Ruth Garside

The GRADE-CERQual (‘Confidence in the Evidence from Reviews of Qualitative research’) approach provides guidance for assessing how much confidence to place in findings from systematic reviews of qualitative research (or qualitative evidence syntheses). The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. Confidence in the evidence from qualitative evidence syntheses is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. CERQual provides a systematic and transparent framework for assessing confidence in individual review findings, based on consideration of four components: (1) methodological limitations, (2) coherence, (3) adequacy of data, and (4) relevance. A fifth component, dissemination (or publication) bias, may also be important and is being explored. As with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach for effectiveness evidence, CERQual suggests summarising evidence in succinct, transparent, and informative Summary of Qualitative Findings tables. These tables are designed to communicate the review findings and the CERQual assessment of confidence in each finding. This article is the first of a seven-part series providing guidance on how to apply the CERQual approach. In this paper, we describe the rationale and conceptual basis for CERQual, the aims of the approach, how the approach was developed, and its main components. We also outline the purpose and structure of this series and discuss the growing role for qualitative evidence in decision-making. Papers 3, 4, 5, 6, and 7 in this series discuss each CERQual component, including the rationale for including the component in the approach, how the component is conceptualised, and how it should be assessed. Paper 2 discusses how to make an overall assessment of confidence in a review finding and how to create a Summary of Qualitative Findings table. The series is intended primarily for those undertaking qualitative evidence syntheses or using their findings in decision-making processes but is also relevant to guideline development agencies, primary qualitative researchers, and implementation scientists and practitioners.

Simon Lewin and colleagues present a methodology for increasing transparency and confidence in qualitative research synthesis.

Attention Restoration Theory (ART) suggests the ability to concentrate may be restored by exposure to natural environments. Although widely cited, it is unclear as to the quantity of empirical evidence that supports this. A systematic review regarding the impact of exposure to natural environments on attention was conducted. Seven electronic databases were searched. Studies were included if (1) they were natural experiments, randomized investigations, or recorded “before and after” measurements; (2) compared natural and nonnatural/other settings; and (3) used objective measures of attention. Screening of articles for inclusion, data extraction, and quality appraisal were performed by one reviewer and checked by another. Where possible, random effects meta-analysis was used to pool effect sizes. Thirty-one studies were included. Meta-analyses provided some support for ART, with significant positive effects of exposure to natural environments for three measures (Digit Span Forward, Digit Span Backward, and Trail Making Test B). The remaining 10 meta-analyses did not show marked beneficial effects. Meta-analysis was limited by small numbers of investigations, small samples, heterogeneity in reporting of study quality indicators, and heterogeneity of outcomes. This review highlights the diversity of evidence around ART in terms of populations, study design, and outcomes. There is uncertainty regarding which aspects of attention may be affected by exposure to natural environments.

The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on making an overall assessment of confidence in a review finding and creating a CERQual Evidence Profile and a CERQual Summary of Qualitative Findings table.We developed this guidance by examining the methods used by other GRADE approaches, gathering feedback from relevant research communities and developing consensus through project group meetings. We then piloted the guidance on several qualitative evidence syntheses before agreeing on the approach.Confidence in the evidence is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. Creating a summary of each review finding and deciding whether or not CERQual should be used are important steps prior to assessing confidence. Confidence should be assessed for each review finding individually, based on the judgements made for each of the four CERQual components. Four levels are used to describe the overall assessment of confidence: high, moderate, low or very low. The overall CERQual assessment for each review finding should be explained in a CERQual Evidence Profile and Summary of Qualitative Findings table.Structuring and summarising review findings, assessing confidence in those findings using CERQual and creating a CERQual Evidence Profile and Summary of Qualitative Findings table should be essential components of undertaking qualitative evidence syntheses. This paper describes the end point of a CERQual assessment and should be read in conjunction with the other papers in the series that provide information on assessing individual CERQual components.

The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method implementation evidence. Choice of appropriate methodologies, methods, and tools is essential when developing a rigorous protocol and conducting the synthesis. Cochrane authors who conduct qualitative evidence syntheses have thus far used a small number of relatively simple methods to address similarly written questions. Cochrane has invested in methodological work to develop new tools and to encourage the production of exemplar reviews to show the value of more innovative methods that address a wider range of questions. In this paper, in the series, we report updated guidance on the selection of tools to assess methodological limitations in qualitative studies and methods to extract and synthesize qualitative evidence. We recommend application of Grades of Recommendation, Assessment, Development, and Evaluation–Confidence in the Evidence from Qualitative Reviews to assess confidence in qualitative synthesized findings. This guidance aims to support review authors to undertake a qualitative evidence synthesis that is intended to be integrated subsequently with the findings of one or more Cochrane reviews of the effects of similar interventions. The review of intervention effects may be undertaken concurrently with or separate to the qualitative evidence synthesis. We encourage further development through reflection and formal testing.

Seventy six senior academics from 11 countries invite <i>The BMJ</i>’s editors to reconsider their policy of rejecting qualitative research on the grounds of low priority. They challenge the journal to develop a proactive, scholarly, and pluralist approach to research that aligns with its stated mission

Objectives To investigate the harmful health effects of taking ecstasy (3,4-methylenedioxymethamphetamine, MDMA) for recreational purposes. Data sources MEDLINE, EMBASE, PsycINFO and Web of Knowledge were searched. Additional information on deaths was collected from the General Mortality Register (GMR) and the Special Mortality Register collated by the National Programme on Substance Abuse Deaths (np-SAD). Review methods Studies were categorised according to design, with systematic research syntheses (Level I evidence) the most valid and least open to bias. Where Level I evidence was not available, controlled observational studies (Level II evidence) were systematically reviewed. If neither Level I nor Level II evidence was available, uncontrolled case series and case reports (Level III evidence) were systematically surveyed. Data were extracted by one reviewer and a sample checked by a second. The heterogeneity of Level II evidence was addressed by undertaking stratified analyses for current and former ecstasy users and comparing them either with control groups using other illegal drugs but not ecstasy (polydrug controls) or with controls naïve to illegal drugs (drug-naïve controls). Statistical heterogeneity was minimised by using a random-effects model throughout and investigated using study-level regression analysis (metaregression). Results Five Level I syntheses were identified; for each it was difficult to ascertain the exact methods adopted and evidence included. Small but significant deficits for ecstasy users compared to controls were reported in areas relating to attention, memory, psychomotor speed, executive systems functioning, and self-reported depressive symptoms. Data from Level II studies were directly pooled for seven individual outcomes, suggesting that ecstasy users performed worse than controls on common measures of immediate and delayed verbal recall (RAVLT, RBMT, digit span). No difference was seen in IQ (NART). The 915 outcome measures identified in Level II studies were analysed in broad domains: immediate and delayed verbal and visual memory, working memory, two measures of attention, three measures of executive function, perceptual organisation, self-rated depression, memory and anxiety, and impulsivity measured objectively and subjectively. Ecstasy users performed significantly worse than polydrug controls in 13/16 domains and significantly worse than drug-naïve controls in 7/12 domains for which sufficient data were available. The largest, most consistent exposure effects were seen in meta-analyses of memory (especially verbal and working memory, with less marked effects seen in visual memory). Former ecstasy users frequently showed deficits that matched or exceeded those seen amongst current users. At aggregate level, the effects do not appear to be dose-related, but are variably confounded by other drug use, particularly alcohol. Of Level III evidence, in the 10 years to 2006, the np-SAD and the GMR recorded an average of around 50 drug-related deaths per year involving ecstasy; it was the sole drug implicated in around 10 cases per year. Retrospective case series, based on hospital emergency department records, reported a death rate of 0–2% from emergency admissions related to ecstasy. Two major syndromes are most commonly reported as the immediate cause of death in fatal cases: hyperthermia and hyponatraemia. Conclusions A broad range of relatively low-quality literature suggests that recreational use of ecstasy is associated with significant deficits in neurocognitive function (particularly immediate and delayed verbal memory) and increased psychopathological symptoms. The clinical significance of the exposure effect in individual cases will be variable but, on average, deficits are likely to be relatively small. Ecstasy is associated with a range of acute harms but appears to be a rare cause of death in isolation.

Systematic literature searching is recognised as a critical component of the systematic review process. It involves a systematic search for studies and aims for a transparent report of study identification, leaving readers clear about what was done to identify studies, and how the findings of the review are situated in the relevant evidence. Information specialists and review teams appear to work from a shared and tacit model of the literature search process. How this tacit model has developed and evolved is unclear, and it has not been explicitly examined before. The purpose of this review is to determine if a shared model of the literature searching process can be detected across systematic review guidance documents and, if so, how this process is reported in the guidance and supported by published studies. A literature review. Two types of literature were reviewed: guidance and published studies. Nine guidance documents were identified, including: The Cochrane and Campbell Handbooks. Published studies were identified through ‘pearl growing’, citation chasing, a search of PubMed using the systematic review methods filter, and the authors’ topic knowledge. The relevant sections within each guidance document were then read and re-read, with the aim of determining key methodological stages. Methodological stages were identified and defined. This data was reviewed to identify agreements and areas of unique guidance between guidance documents. Consensus across multiple guidance documents was used to inform selection of ‘key stages’ in the process of literature searching. Eight key stages were determined relating specifically to literature searching in systematic reviews. They were: who should literature search, aims and purpose of literature searching, preparation, the search strategy, searching databases, supplementary searching, managing references and reporting the search process. Eight key stages to the process of literature searching in systematic reviews were identified. These key stages are consistently reported in the nine guidance documents, suggesting consensus on the key stages of literature searching, and therefore the process of literature searching as a whole, in systematic reviews. Further research to determine the suitability of using the same process of literature searching for all types of systematic review is indicated.

The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting.Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality.The eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes.The study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes.Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance.The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.

This paper is one of a series exploring the implications of complexity for systematic reviews and guideline development, commissioned by the WHO. The paper specifically explores the role of qualitative evidence synthesis. Qualitative evidence synthesis is the broad term for the group of methods used to undertake systematic reviews of qualitative research evidence. As an approach, qualitative evidence synthesis is increasingly recognised as having a key role to play in addressing questions relating to intervention or system complexity, and guideline development processes. This is due to the unique role qualitative research can play in establishing the relative importance of outcomes, the acceptability, fidelity and reach of interventions, their feasibility in different settings and potential consequences on equity across populations. This paper outlines the purpose of qualitative evidence synthesis, provides detail of how qualitative evidence syntheses can help establish understanding and explanation of the complexity that can occur in relation to both interventions and systems, and how qualitative evidence syntheses can contribute to evidence to decision frameworks. It provides guidance for the choice of qualitative evidence synthesis methods in the context of guideline development for complex interventions, giving ‘real life’ examples of where this has occurred. Information to support decision-making around choice qualitative evidence synthesis methods in the context of guideline development is provided. Approaches for reporting qualitative evidence syntheses are discussed alongside mechanisms for assessing confidence in the findings of a review.

Antibiotic-resistant bacteria (ARB) present a global public health problem. With numbers of community-acquired resistant infections increasing, understanding the mechanisms by which people are exposed to and colonised by ARB can help inform effective strategies to prevent their spread. The role natural environments play in this is poorly understood. This is the first study to combine surveillance of ARB in bathing waters, human exposure estimates and association between exposure and colonisation by ARB in water users. 97 bathing water samples from England and Wales were analysed for the proportion of E. coli harbouring blaCTX-M. These data were used to estimate the likelihood of water users ingesting blaCTX-M-bearing E. coli. Having identified surfers as being at risk of exposure to ARB, a cross-sectional study was conducted. Regular surfers and non-surfers were recruited to assess whether there is an association between surfing and gut colonisation by blaCTX-M-bearing E. coli. 11 of 97 bathing waters sampled were found to contain blaCTX-M-bearing E. coli. While the percentage of blaCTX-M-bearing E. coli in bathing waters was low (0.07%), water users are at risk of ingesting these ARB. It is estimated that over 2.5 million water sports sessions occurred in 2015 resulting in the ingestion of at least one blaCTX-M-bearing E. coli. In the epidemiological survey, 9/143 (6.3%) surfers were colonised by blaCTX-M-bearing E. coli, as compared to 2/130 (1.5%) of non-surfers (risk ratio = 4.09, 95% CI 1.02 to 16.4, p = 0.046). Surfers are at risk of exposure to and colonisation by clinically important antibiotic-resistant E. coli in coastal waters. Further research must be done on the role natural environments play in the transmission of ARB.

The use of non-medical referral, community referral or social prescribing interventions has been proposed as a cost-effective alternative to help those with long-term conditions manage their illness and improve health and well-being. However, the evidence base for social prescribing currently lags considerably behind practice. In this paper, we explore what is known about whether different methods of social prescribing referral and supported uptake do (or do not) work. Supported by an Expert Advisory Group, we conducted a realist review in two phases. The first identified evidence specifically relating to social prescribing in order to develop programme theories in the form of ‘if-then’ statements, articulating how social prescribing models are expected to work. In the second phase, we aimed to clarify these processes and include broader evidence to better explain the proposed mechanisms. The first phase resulted in 109 studies contributing to the synthesis, and the second phase 34. We generated 40 statements relating to organising principles of how the referral takes place (Enrolment), is accepted (Engagement), and completing an activity (Adherence). Six of these statements were prioritised using web-based nominal group technique by our Expert Group. Studies indicate that patients are more likely to enrol if they believe the social prescription will be of benefit, the referral is presented in an acceptable way that matches their needs and expectations, and concerns elicited and addressed appropriately by the referrer. Patients are more likely to engage if the activity is both accessible and transit to the first session supported. Adherence to activity programmes can be impacted through having an activity leader who is skilled and knowledgeable or through changes in the patient's conditions or symptoms. However, the evidence base is not sufficiently developed methodologically for us to make any general inferences about effectiveness of particular models or approaches.

Infections caused by antibiotic resistant bacteria (ARB) are associated with poor health outcomes and are recognised globally as a serious health problem. Much research has been conducted on the transmission of ARB to humans. Yet the role the natural environment plays in the spread of ARB and antibiotic resistance genes is not well understood. Antibiotic resistant bacteria have been detected in natural aquatic environments, and ingestion of seawater during water sports is one route by which many people could be directly exposed. The aim was to estimate the prevalence of resistance to one clinically important class of antibiotics (third-generation cephalosporins (3GCs)) amongst Escherichia coli in coastal surface waters in England and Wales. Prevalence data was used to quantify ingestion of 3GC-resistant E. coli (3GCREC) by people participating in water sports in designated coastal bathing waters. A further aim was to use this value to derive a population-level estimate of exposure to these bacteria during recreational use of coastal waters in 2012. The prevalence of 3GC-resistance amongst E. coli isolated from coastal surface waters was estimated using culture-based methods. This was combined with the density of E. coli reported in designated coastal bathing waters along with estimations of the volumes of water ingested during various water sports reported in the literature to calculate the mean number of 3GCREC ingested during different water sports. 0.12% of E. coli isolated from surface waters were resistant to 3GCs. This value was used to estimate that in England and Wales over 6.3 million water sport sessions occurred in 2012 that resulted in the ingestion of at least one 3GCREC. Despite the low prevalence of resistance to 3GCs amongst E. coli in surface waters, there is an identifiable human exposure risk for water users, which varies with the type of water sport undertaken. The relative importance of this exposure is likely to be greater in areas where a large proportion of the population enjoys water sports. Millions of water sport sessions occurred in 2012 that were likely to have resulted in people ingesting E. coli resistant to a single class of antibiotics (3GCs). However, this is expected to be a significant underestimate of recreational exposure to all ARB in seawater. This is the first study to use volumes of water ingested during different water sports to estimate human exposure to ARB. Further work needs to be done to elucidate the health implications and clinical relevance of exposure to ARB in both marine and fresh waters in order to fully understand the risk to public health.

Abstract Background Global policy initiatives and international conservation organizations have sought to emphasize and strengthen the link between the conservation of natural ecosystems and human development. While many indices have been developed to measure various social outcomes to conservation interventions, the quantity and strength of evidence to support the effects, both positive and negative, of conservation on different dimensions of human well-being, remain unclear, dispersed and inconsistent. Methods We searched 11 academic citation databases, two search engines and 30 organisational websites for relevant articles using search terms tested with a library of 20 relevant articles. Key informants were contacted with requests for articles and possible sources of evidence. Articles were screened for relevance against predefined inclusion criteria at title, abstract and full text levels according to a published protocol. Included articles were coded using a questionnaire. A critical appraisal of eight systematic reviews was conducted to assess the reliability of methods and confidence in study findings. A visual matrix of the occurrence and extent of existing evidence was also produced. Results A total of 1043 articles were included in the systematic map database. Included articles measured effects across eight nature conservation-related intervention and ten human well-being related outcome categories. Linkages between interventions and outcomes with high occurrence of evidence include resource management interventions, such as fisheries and forestry, and economic and material outcomes. Over 25 % of included articles examined linkages between protected areas and aspects of economic well-being. Fewer than 2 % of articles evaluated human health outcomes. Robust study designs were limited with less than 9 % of articles using quantitative approaches to evaluate causal effects of interventions. Over 700 articles occurred in forest biomes with less than 50 articles in deserts or mangroves, combined. Conclusions The evidence base is growing on conservation-human well-being linkages, but biases in the extent and robustness of articles on key linkages persist. Priorities for systematic review, include linkages between marine resource management and economic/material well-being outcomes; and protected areas and governance outcomes. Greater and more robust evidence is needed for many established interventions to better understand synergies and trade-offs between interventions, in particular those that are emerging or contested. Registration CEE review 14-012

The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual’s methodological limitations component. We developed the methodological limitations component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual methodological limitations component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. When applying CERQual, we define methodological limitations as the extent to which there are concerns about the design or conduct of the primary studies that contributed evidence to an individual review finding. In this paper, we describe the methodological limitations component and its rationale and offer guidance on how to assess methodological limitations of a review finding as part of the CERQual approach. This guidance outlines the information required to assess methodological limitations component, the steps that need to be taken to assess methodological limitations of data contributing to a review finding and examples of methodological limitation assessments. This paper provides guidance for review authors and others on undertaking an assessment of methodological limitations in the context of the CERQual approach. More work is needed to determine which criteria critical appraisal tools should include when assessing methodological limitations. We currently recommend that whichever tool is used, review authors provide a transparent description of their assessments of methodological limitations in a review finding. We expect the CERQual approach and its individual components to develop further as our experiences with the practical implementation of the approach increase.

The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations; (2) coherence; (3) adequacy of data; and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual’s adequacy of data component. We developed the adequacy of data component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual adequacy of data component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. When applying CERQual, we define adequacy of data as an overall determination of the degree of richness and the quantity of data supporting a review finding. In this paper, we describe the adequacy component and its rationale and offer guidance on how to assess data adequacy in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess data adequacy, the steps that need to be taken to assess data adequacy, and examples of adequacy assessments. This paper provides guidance for review authors and others on undertaking an assessment of adequacy in the context of the CERQual approach. We approach assessments of data adequacy in terms of the richness and quantity of the data supporting each review finding, but do not offer fixed rules regarding what constitutes sufficiently rich data or an adequate quantity of data. Instead, we recommend that this assessment is made in relation to the nature of the finding. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.

The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's relevance component.We developed the relevance component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual relevance component within several qualitative evidence syntheses before agreeing on the current definition and principles for application.When applying CERQual, we define relevance as the extent to which the body of data from the primary studies supporting a review finding is applicable to the context (perspective or population, phenomenon of interest, setting) specified in the review question. In this paper, we describe the relevance component and its rationale and offer guidance on how to assess relevance in the context of a review finding. This guidance outlines the information required to assess relevance, the steps that need to be taken to assess relevance and examples of relevance assessments.This paper provides guidance for review authors and others on undertaking an assessment of relevance in the context of the CERQual approach. Assessing the relevance component requires consideration of potentially important contextual factors at an early stage in the review process. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.

The GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) relevance, (3) coherence and (4) adequacy of data. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual’s coherence component. We developed the coherence component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual coherence component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. When applying CERQual, we define coherence as how clear and cogent the fit is between the data from the primary studies and a review finding that synthesises that data. In this paper, we describe the coherence component and its rationale and offer guidance on how to assess coherence in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess coherence, the steps that need to be taken to assess coherence and examples of coherence assessments. This paper provides guidance for review authors and others on undertaking an assessment of coherence in the context of the CERQual approach. We suggest that threats to coherence may arise when the data supporting a review finding are contradictory, ambiguous or incomplete or where competing theories exist that could be used to synthesise the data. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.

Exposure to ‘real’ nature can increase positive affect and decrease negative affect, but direct access is not always possible, e.g. for people in health/care settings who often experience chronic boredom. In these settings ‘virtual’ forms of nature may also have mood-related benefits (e.g. reducing boredom) but it has been difficult to separate effects of nature content from those of delivery mode. The present laboratory-based study explored whether exposure to three different delivery modes of virtual nature could reduce negative affect (including boredom) and/or increase positive affect. Adult volunteer participants (n = 96) took part in a boredom induction task (to simulate the emotional state of many people in health/care settings) before being randomly assigned to view/interact with a virtual underwater coral reef in one of three experimental conditions: (a) 2D video viewed on a high-definition TV screen; (b) 3600 video VR (360-VR) viewed via a head mounted display (HMD); or (c) interactive computer-generated VR (CG-VR), also viewed via a HMD and interacted with using a hand-held controller. Visual and auditory content was closely matched across conditions with help from the BBC's Blue Planet II series team. Supporting predictions, virtual exposure to a coral reef reduced boredom and negative affect and increased positive affect and nature connectedness. Although reductions in boredom and negative affect were similar across all three conditions, CG-VR was associated with significantly greater improvements in positive affect than TV, which were mediated by greater experienced presence and increases in nature connectedness. Results improve our understanding of the importance of virtual nature delivery mode and will inform studies in real care settings.

In this review of reviews, we overview the current global body of available evidence from structured reviews of epidemiological studies that explore human health outcomes associated with exposure to phthalates (chemical plasticisers commonly found in plastics). We found robust evidence for an association with lower semen quality, neurodevelopment and risk of childhood asthma, and moderate to robust evidence for impact on anogenital distance in boys. We identified moderate evidence for an association between phthalates/metabolites and low birthweight, endometriosis, decreased testosterone, ADHD, Type 2 diabetes and breast/uterine cancer. There was some evidence for other outcomes including anofourchette distance, fetal sex hormones, pre-term birth, lower antral follicle count, reduced oestrodiol, autism, obesity, thyroid function and hearing disorders. We found no reviews of epidemiological human studies on the impact of phthalates from recycled plastics on human health. We recommend that future research should use urine samples as exposure measures, consider confounders in analyses and measure impacts on female reproductive systems. Our findings align with emerging research indicating that health risks can occur at exposure levels below the "safe dose" levels set out by regulators, and are of particular concern given potential additive or synergistic "cocktail effects" of chemicals. This raises important policy and regulatory issues for identifying and controlling plastics and health related impacts and highlights a need for more research into substances of concern entering plastics waste streams via recycling.

Objective To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis.Design Systematic review and meta-analysis.Data sources Electronic searches of the Cochrane Library, Medline, and Embase.Study selection Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability.Data extraction Efficacy: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life.Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections.Data synthesis 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus.Both drugs were significantly more effective than a vehicle control.Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6).Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4).In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8).Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99).Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks).Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids.Rates of skin infections in any of the comparisons did not differ.Conclusions Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear.Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly.In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear.The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear. MethodsWe included randomised controlled trials that compared topical pimecrolimus or topical tacrolimus at a licensed therapeutic dose with vehicle or another active treatment (for example, topical corticosteroids) in patients with atopic dermatitis, and that reported efficacy outcomes or adverse events.

To examine the impact of gardens and outdoor spaces on the mental and physical well-being of people with dementia who are resident in care homes and understand the views of people with dementia, their carers, and care home staff on the value of gardens and outdoor spaces.Systematic review.Fourteen databases were searched from inception to February 2013. Forward and backward citation chasing of included articles was conducted; 38 relevant organizations were contacted to identify unpublished reports. Titles, abstracts, and full texts were screened independently by 2 reviewers in a 2-stage process and were discussed with a third reviewer where necessary. Results were synthesized narratively.Seventeen studies were included: 9 quantitative, 7 qualitative, and 1 mixed methods. The quantitative studies were of poor quality but suggested decreased levels of agitation were associated with garden use. The views and experiences of the garden are discussed in relation to themes of how the garden was used, nature of interactions, impact/effect of the gardens, mechanisms/how the garden was thought to have an effect, and negatives (such as perception of the garden as a hazard and the limited staff time).There are promising impacts on levels of agitation in care home residents with dementia who spend time in a garden. Future research would benefit from a focus on key outcomes measured in comparable ways with a separate focus on what lies behind limited accessibility to gardens within the residential care setting.

In the UK, women aged 50-73 years are invited for screening by mammography every 3 years. In 2009-10, more than 2.24 million women in this age group in England were invited to take part in the programme, of whom 73% attended a screening clinic. Of these, 64,104 women were recalled for assessment. Of those recalled, 81% did not have breast cancer; these women are described as having a false-positive mammogram.The aim of this systematic review was to identify the psychological impact on women of false-positive screening mammograms and any evidence for the effectiveness of interventions designed to reduce this impact. We were also looking for evidence of effects in subgroups of women.MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Health Management Information Consortium, Cochrane Central Register for Controlled Trials, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination (CRD) Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment (HTA), Cochrane Methodology, Web of Science, Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index-Science, Conference Proceeding Citation Index-Social Science and Humanities, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Sociological Abstracts, the International Bibliography of the Social Sciences, the British Library's Electronic Table of Contents and others. Initial searches were carried out between 8 October 2010 and 25 January 2011. Update searches were carried out on 26 October 2011 and 23 March 2012.Based on the inclusion criteria, titles and abstracts were screened independently by two reviewers. Retrieved papers were reviewed and selected using the same independent process. Data were extracted by one reviewer and checked by another. Each included study was assessed for risk of bias.Eleven studies were found from 4423 titles and abstracts. Studies that used disease-specific measures found a negative psychological impact lasting up to 3 years. Distress increased with the level of invasiveness of the assessment procedure. Studies using instruments designed to detect clinical levels of morbidity did not find this effect. Women with false-positive mammograms were less likely to return for the next round of screening [relative risk (RR) 0.97; 95% confidence interval (CI) 0.96 to 0.98] than those with normal mammograms, were more likely to have interval cancer [odds ratio (OR) 3.19 (95% CI 2.34 to 4.35)] and were more likely to have cancer detected at the next screening round [OR 2.15 (95% CI 1.55 to 2.98)].This study was limited to UK research and by the robustness of the included studies, which frequently failed to report quality indicators, for example failure to consider the risk of bias or confounding, or failure to report participants' demographic characteristics.We conclude that the experience of having a false-positive screening mammogram can cause breast cancer-specific psychological distress that may endure for up to 3 years, and reduce the likelihood that women will return for their next round of mammography screening. These results should be treated cautiously owing to inherent weakness of observational designs and weaknesses in reporting. Future research should include a qualitative interview study and observational studies that compare generic and disease-specific measures, collect demographic data and include women from different social and ethnic groups.

More than a third of people over the age of 65 years fall each year. Falling can lead to a reduction in quality of life, mortality, and a risk of prolonged hospitalisation. Reducing and preventing falls has become an international health priority. To help understand why research evidence has often not been translated into changes in clinical practice, we undertook a systematic review and synthesis of qualitative research in order to identify what factors serve as barriers and facilitators to the successful implementation of fall-prevention programmes. We conducted a review of literature published between 1980 and January 2012 for qualitative research studies that examined barriers and facilitators to the effective implementation of fall-prevention interventions among community-dwelling older people and healthcare professionals. Two reviewers independently screened studies for inclusion, extracted data, and assessed methodological quality according to predefined criteria. Findings were synthesised using meta-ethnography. Of the 5010 articles identified through database searching, 19 were included in the review. Analysis of the 19 studies revealed limited information about the mechanisms by which barriers to implementation of fall-prevention interventions had been overcome. Data synthesis produced three overarching concepts: (1) practical considerations, (2) adapting for community, and (3) psychosocial. A line of argument synthesis describes the barriers and facilitators to the successful implementation of fall-prevention programmes. These concepts show that the implementation of fall-prevention programmes is complex and multifactorial. This is the first systematic review and synthesis of qualitative studies to examine factors influencing the implementation of fall-prevention programmes from the perspectives of both the healthcare professional and the community-dwelling older person. The current literature on barriers and facilitators to the implementation of fall-prevention programmes examines a variety of interventions. However, the ways in which the interventions are reported suggests there are substantial methodological challenges that often inhibit implementation into practice. We recommend that successful implementation requires individuals, professionals, and organisations to modify established behaviours, thoughts, and practice. The issues identified through this synthesis need to be fully considered and addressed if fall-prevention programmes are to be successfully implemented into clinical practice.

School gardening programmes are increasingly popular, with suggested benefits including healthier eating and increased physical activity. Our objectives were to understand the health and well-being impacts of school gardens and the factors that help or hinder their success. We conducted a systematic review of quantitative and qualitative evidence (PROSPERO CRD42014007181). We searched multiple databases and used a range of supplementary approaches. Studies about school gardens were included if they reported on physical or mental health or well-being. Quantitative studies had to include a comparison group. Studies were quality appraised using appropriate tools. Findings were narratively synthesised and the qualitative evidence used to produce a conceptual framework to illustrate how benefits might be accrued. Evidence from 40 articles (21 quantitative studies; 16 qualitative studies; 3 mixed methods studies) was included. Generally the quantitative research was poor. Evidence for changes in fruit and vegetable intake was limited and based on self-report. The qualitative research was better quality and ascribed a range of health and well-being impacts to school gardens, with some idealistic expectations for their impact in the long term. Groups of pupils who do not excel in classroom activities were thought to particularly benefit. Lack of funding and over reliance on volunteers were thought to threaten success, while involvement with local communities and integration of gardening activities into the school curriculum were thought to support success. More robust quantitative research is needed to convincingly support the qualitative evidence suggesting wide ranging benefits from school gardens.

Behaviour change interventions can be effective in helping people to lose weight, but weight is often regained. Effective interventions are required to prevent this. We conducted a systematic review and synthesis of qualitative research on people's experiences of weight loss maintenance. We searched bibliographic databases for qualitative studies about the experience of currently or previously overweight adults trying to maintain weight loss. We thematically synthesised study findings to develop a model of weight loss maintenance. Twenty six studies from five countries with 710 participants were included. The model developed through our synthesis proposes that making the behaviour changes required for weight loss maintenance generates psychological 'tension' due to the need to override existing habits, and incompatibility of the new behaviours with the fulfilment of psychological needs. Successful maintenance involves management or resolution of this tension. Management of tension can be achieved through self-regulation, renewing of motivation and managing external influences, although this can require constant effort. Resolution may be achieved through changing habits, finding non-obesogenic methods for addressing needs, and potentially through change in self-concept. Implications for the development of weight loss maintenance interventions are explored.

To quantify and compare the treatment effect and risk of bias of trials reporting biomarkers or intermediate outcomes (surrogate outcomes) versus trials using final patient relevant primary outcomes.Meta-epidemiological study.All randomised clinical trials published in 2005 and 2006 in six high impact medical journals: Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Lancet, New England Journal of Medicine, and PLoS Medicine.Two independent reviewers selected trials.Trial characteristics, risk of bias, and outcomes were recorded according to a predefined form. Two reviewers independently checked data extraction. The ratio of odds ratios was used to quantify the degree of difference in treatment effects between the trials using surrogate outcomes and those using patient relevant outcomes, also adjusted for trial characteristics. A ratio of odds ratios >1.0 implies that trials with surrogate outcomes report larger intervention effects than trials with patient relevant outcomes.84 trials using surrogate outcomes and 101 using patient relevant outcomes were considered for analyses. Study characteristics of trials using surrogate outcomes and those using patient relevant outcomes were well balanced, except for median sample size (371 v 741) and single centre status (23% v 9%). Their risk of bias did not differ. Primary analysis showed trials reporting surrogate endpoints to have larger treatment effects (odds ratio 0.51, 95% confidence interval 0.42 to 0.60) than trials reporting patient relevant outcomes (0.76, 0.70 to 0.82), with an unadjusted ratio of odds ratios of 1.47 (1.07 to 2.01) and adjusted ratio of odds ratios of 1.46 (1.05 to 2.04). This result was consistent across sensitivity and secondary analyses.Trials reporting surrogate primary outcomes are more likely to report larger treatment effects than trials reporting final patient relevant primary outcomes. This finding was not explained by differences in the risk of bias or characteristics of the two groups of trials.

High grade glioma (HGG) is an aggressive form of brain cancer. Treatment of HGG usually entails biopsy, or resection if safe, followed by radiotherapy. Temozolomide is a novel oral chemotherapy drug that penetrates into the brain and purportedly has a low incidence of adverse events.To assess whether temozolomide has any advantage for treating HGG in either primary or recurrent disease settings.The following databases were searched: CENTRAL (Issue 10, 2012), MEDLINE, EMBASE, Science Citation Index, Physician Data Query and the Meta-Register of Controlled Trials in October, 2012. Reference lists of identified studies were searched. The Journal of Neuro-Oncology and Neuro-oncology were handsearched from 1999 to 2012 including conference abstracts. We contacted neuro-oncologists regarding ongoing and unpublished trials.Randomised controlled trials (RCTs) where the interventions were the use of temozolomide during primary therapy or for recurrent disease. Comparisons included no chemotherapy, non-temozolomide chemotherapy or different dosing schedules of temozolomide. Patients included those of all ages with histologically proven HGG.Two review authors undertook the quality assessment and data extraction. Outcome measures included: overall survival (OS); progression-free survival (PFS); quality of life (QoL); and adverse events.For primary therapy three RCTs were identified, enrolling a total of 745 patients, that investigated temozolomide in combination with radiotherapy versus radiotherapy alone for glioblastoma multiforme (GBM). Temozolomide increased OS (hazard ratio (HR) 0.60, 95% confidence interval (CI) 0.46 to 0.79, P value 0.0003) and increased PFS (HR 0.63, 95% CI 0.43 to 0.92, P value 0.02), when compared with radiotherapy alone, although these benefits only appear to emerge when therapy is given in both concomitant and adjuvant phases of treatment. A single RCT found that temozolomide did not have a statistically significant effect on QoL. Risk of haematological complications, fatigue and infections were increased with temozolomide.In recurrent HGG, two RCTs enrolling 672 patients in total found that temozolomide did not increase OS compared to standard chemotherapy (HR 0.9, 95% CI 0.76 to 1.06, P value 0.2) but it did increase PFS in a subgroup analysis of grade IV GBM tumours (HR 0.68, 95% CI 0.51 to 0.90, P value 0.008). Adverse events were similar between arms.In the elderly, 2 RCTs of 664 patients found OS and PFS was similar with temozolomide alone versus radiotherapy alone. QoL did not appear to differ between arms in a single trial but certain adverse events were significantly more common with temozolomide.Temozolomide when given in both concomitant and adjuvant phases is an effective primary therapy in GBM compared to radiotherapy alone. It prolongs survival and delays progression without impacting on QoL but it does increase early adverse events. In recurrent GBM, temozolomide compared with standard chemotherapy improves time-to-progression (TTP) and may have benefits on QoL without increasing adverse events but it does not improve overall. In the elderly, temozolomide alone appears comparable to radiotherapy in terms of OS and PFS but with a higher instance of adverse events.

Cochrane reviews are systematic reviews of primary research in human health care and health policy and are internationally recognized health care resources for use in a decision-making process [ [1] Jørgensen A.W. Hilden J. Gøtzsche P.C. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. Research. 2006; 333: 782 Google Scholar ]. Cochrane works collaboratively with contributors around the world to produce authoritative, relevant, and reliable reviews. Cochrane reviews are commonly used in a guideline development process to determine recommendations for practice. The Cochrane Qualitative and Implementation Methods Group provide methodological advice and guidance to Cochrane as well as leading methodological development to benefit the wider qualitative evidence synthesis community. In this introductory paper 1, we briefly outline the evolution of qualitative and mixed-method synthesis methods, the role of qualitative and mixed-method syntheses in a decision-making process, and the contribution of qualitative and mixed-method syntheses to understand the complexity in complex intervention reviews. We then introduce a series of papers that provide Cochrane guidance on conducting qualitative and mixed-method evidence syntheses for a decision-making context.

This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whether evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. The process of question formulation allows reviewers to situate the topic in relation to how it informs and explains effectiveness, using the criterion of meaningfulness, appropriateness, feasibility, and implementation. Questions related to complex questions and interventions can be structured by drawing on an increasingly wide range of question frameworks. Logic models and theoretical frameworks are useful tools for conceptually mapping the literature to illustrate the complexity of the phenomenon of interest. Furthermore, protocol development may require iterative question formulation and searching. Consequently, the final protocol may function as a guide rather than a prescriptive route map, particularly in qualitative reviews that ask more exploratory and open-ended questions.

<h2>Abstract</h2> The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this article, we report updated guidance from the group on approaches, methods, and tools, which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations. We draw on conceptual analyses of mixed methods systematic review designs and the range of methods and tools that have been used in published reviews that have successfully integrated different types of evidence. We outline five key methods and tools as devices for integration which vary in terms of the levels at which integration takes place; the specialist skills and expertise required within the review team; and their appropriateness in the context of limited evidence. In situations where the requirement is the integration of qualitative and process evidence within intervention effectiveness reviews, we recommend the use of a sequential approach. Here, evidence from each tradition is synthesized separately using methods consistent with each tradition before integration takes place using a common framework. Reviews which integrate qualitative and process evaluation evidence alongside quantitative evidence on intervention effectiveness in a systematic way are rare. This guidance aims to support review teams to achieve integration and we encourage further development through reflection and formal testing.

Robopets are small animal-like robots which have the appearance and behavioural characteristics of pets.To bring together the evidence of the experiences of staff, residents and family members of interacting with robopets and the effects of robopets on the health and well-being of older people living in care homes.Systematic review of qualitative and quantitative research.We searched 13 electronic databases from inception to July 2018 and undertook forward and backward citation chasing.Eligible studies reported the views and experiences of robopets from residents, family members and staff (qualitative studies using recognised methods of qualitative data collection and analysis) and the effects of robopets on the health and well-being of care home residents (randomised controlled trials, randomised crossover trials and cluster randomised trials). Study selection was undertaken independently by two reviewers. We used the Wallace criteria and the Cochrane Risk of Bias tool to assess the quality of the evidence. We developed a logic model with stakeholders and used this as a framework to guide data extraction and synthesis. Where appropriate, we used meta-analysis to combine effect estimates from quantitative studies.Nineteen studies (10 qualitative, 2 mixed methods and 7 randomised trials) met the inclusion criteria. Interactions with robopets were described as having a positive impact on aspects of well-being including loneliness, depression and quality of life by residents and staff, although there was no corresponding statistically significant evidence from meta-analysis for these outcomes. Meta-analysis showed evidence of a reduction in agitation with the robopet "Paro" compared to control (-0.32 [95% CI -0.61 to -0.04, p = 0.03]). Not everyone had a positive experience of robopets.Engagement with robopets appears to have beneficial effects on the health and well-being of older adults living in care homes, but not all chose to engage. Whether the benefits can be sustained are yet to be investigated.Robopets have the potential to benefit people living in care homes, through increasing engagement and interaction. With the robopet acting as a catalyst, this engagement and interaction may afford comfort and help reduce agitation and loneliness.

AbstractSystematic reviews of qualitative research have increasing currency for evidence-based policy-making. Potentially, this can prevent further marginalization of qualitative evidence, increase our understanding of the body of work undertaken by qualitative researchers and allow broader, more overarching theories about studied phenomenon to be built. Qualitative researchers have so far failed to agree what constitutes “validity” or “quality” in their work: these debates have mirrored the epistemological differences within which such research is undertaken. This paper explores the arguments about quality appraisal and, drawing on this literature, builds a proposal to which, it is hoped, qualitative researchers from across disciplines may be able to ascribe. Technical reporting standards could be agreed that make the conduct of the research clearer. Additional elements, related to study trustworthiness and theoretical and practical considerations, could be appraised discursively, allowing the intention of the researchers working within their particular milieu to be accommodated.Keywords: qualitative researchsystematic reviewresearch methodologypolicy-makingevidence-based policy-making AcknowledgementsI would like to thank Professor N. Britten and Professor K. Stein for their discussions about these issues. Thanks to the peer reviewers for their helpful comments on an earlier draft. The European Centre for Environment and Human Health (part of the University of Exeter Medical School) is supported by investment from the European Regional Development Fund and the European Social Fund Convergence Programme for Cornwall and the Isles of Scilly. Ruth Garside is partially supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula. The views expressed in this publication are those of the author and not necessarily those of the EU, NHS, the NIHR or the Department of Health in England.

Educational policy and the school effectiveness movement often involve rhetoric about the benefit of parent involvement in schools, but high‐quality relationships between parents and teachers are not always straightforwardly achieved, and this may be particularly true in the case of parents of children presenting with academic problems and/or social, emotional and behavioural difficulties. A systematic review of qualitative research was conducted to explore the school‐related experiences of parents of pupils diagnosed with attention deficit hyperactivity disorder ( ADHD ). Six studies reported in seven papers met the inclusion criteria. High‐quality parent–teacher relationships were found to be the exception, with mothers feeling silenced and criticised. Findings show commonalities with wider research about parents, but identify additional grounds for conflict resulting from parental blame for pupils' disruptive behaviour, and the ambivalent nature of the concept of ADHD .

The purpose and contribution of supplementary search methods in systematic reviews is increasingly acknowledged. Numerous studies have demonstrated their potential in identifying studies or study data that would have been missed by bibliographic database searching alone. What is less certain is how supplementary search methods actually work, how they are applied, and the consequent advantages, disadvantages and resource implications of each search method. The aim of this study is to compare current practice in using supplementary search methods with methodological guidance.Four methodological handbooks in informing systematic review practice in the UK were read and audited to establish current methodological guidance. Studies evaluating the use of supplementary search methods were identified by searching five bibliographic databases. Studies were included if they (1) reported practical application of a supplementary search method (descriptive) or (2) examined the utility of a supplementary search method (analytical) or (3) identified/explored factors that impact on the utility of a supplementary method, when applied in practice.Thirty-five studies were included in this review in addition to the four methodological handbooks. Studies were published between 1989 and 2016, and dates of publication of the handbooks ranged from 1994 to 2014. Five supplementary search methods were reviewed: contacting study authors, citation chasing, handsearching, searching trial registers and web searching.There is reasonable consistency between recommended best practice (handbooks) and current practice (methodological studies) as it relates to the application of supplementary search methods. The methodological studies provide useful information on the effectiveness of the supplementary search methods, often seeking to evaluate aspects of the method to improve effectiveness or efficiency. In this way, the studies advance the understanding of the supplementary search methods. Further research is required, however, so that a rational choice can be made about which supplementary search strategies should be used, and when.

Article impact statement : Machine learning optimizes processes of systematic evidence synthesis and improves its utility for evidence‐based conservation.

Systematic review teams and guideline development groups face considerable challenges when considering context within the evidence production process. Many complex interventions are context-dependent and are frequently evaluated within considerable contextual variation and change. This paper considers the extent to which current tools used within systematic reviews and guideline development are suitable in meeting these challenges. The paper briefly reviews strengths and weaknesses of existing approaches to specifying context. Illustrative tools are mapped to corresponding stages of the systematic review process. Collectively, systematic review and guideline production reveals a rich diversity of frameworks and tools for handling context. However, current approaches address only specific elements of context, are derived from primary studies which lack information or have not been tested within systematic reviews. A hypothetical example is used to illustrate how context could be integrated throughout the guideline development process. Guideline developers and evidence synthesis organisations should select an appropriate level of contextual detail for their specific guideline that is parsimonious and yet sensitive to health systems contexts and the values, preferences and needs of their target populations.

Chapter 21 Qualitative evidence Jane Noyes, Jane NoyesSearch for more papers by this authorAndrew Booth, Andrew BoothSearch for more papers by this authorMargaret Cargo, Margaret CargoSearch for more papers by this authorKate Flemming, Kate FlemmingSearch for more papers by this authorAngela Harden, Angela HardenSearch for more papers by this authorJanet Harris, Janet HarrisSearch for more papers by this authorRuth Garside, Ruth GarsideSearch for more papers by this authorKarin Hannes, Karin HannesSearch for more papers by this authorTomás Pantoja, Tomás PantojaSearch for more papers by this authorJames Thomas, James ThomasSearch for more papers by this author Jane Noyes, Jane NoyesSearch for more papers by this authorAndrew Booth, Andrew BoothSearch for more papers by this authorMargaret Cargo, Margaret CargoSearch for more papers by this authorKate Flemming, Kate FlemmingSearch for more papers by this authorAngela Harden, Angela HardenSearch for more papers by this authorJanet Harris, Janet HarrisSearch for more papers by this authorRuth Garside, Ruth GarsideSearch for more papers by this authorKarin Hannes, Karin HannesSearch for more papers by this authorTomás Pantoja, Tomás PantojaSearch for more papers by this authorJames Thomas, James ThomasSearch for more papers by this author Book Editor(s):Julian P.T. Higgins, Julian P.T. HigginsSearch for more papers by this authorJames Thomas, James ThomasSearch for more papers by this authorJacqueline Chandler, Jacqueline ChandlerSearch for more papers by this authorMiranda Cumpston, Miranda CumpstonSearch for more papers by this authorTianjing Li, Tianjing LiSearch for more papers by this authorMatthew J. Page, Matthew J. PageSearch for more papers by this authorVivian A. Welch, Vivian A. WelchSearch for more papers by this author First published: 20 September 2019 https://doi.org/10.1002/9781119536604.ch21Citations: 7 AboutPDFPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShareShare a linkShare onFacebookTwitterLinked InRedditWechat Summary This chapter provides authors (who already have experience of undertaking qualitative research and qualitative evidence synthesis) with additional guidance on undertaking a qualitative evidence synthesis that is subsequently integrated with an intervention review. There are two main designs for synthesizing qualitative evidence with evidence of the effects of interventions: sequential reviews; and convergent mixed-methods review. The Cochrane Qualitative and Implementation Methods Group website provides links to practical guidance and key steps for authors who are considering a qualitative evidence synthesis. The RETREAT framework outlines seven key considerations that review authors should systematically work through when planning a review. The review question is critical to development of the qualitative evidence synthesis. Question development affords a key point for integration with the intervention review. Review authors can integrate a qualitative evidence synthesis with an existing intervention review published on a similar topic, or conduct a new intervention review and qualitative evidence syntheses in parallel before integration. Citing Literature Cochrane Handbook for Systematic Reviews of Interventions, Second Edition RelatedInformation

Antimicrobial resistance (AMR) is predicted to become the leading cause of death by 2050 with antibiotic resistance being an important component. Anthropogenic pollution introduces antibiotic resistant bacteria (ARB) and antibiotic resistance genes (ARGs) to the natural environment. Currently, there is limited empirical evidence demonstrating whether humans are exposed to environmental AMR and whether this exposure can result in measurable human health outcomes. In recent years there has been increasing interest in the role of the environment and disparate evidence on transmission of AMR to humans has been generated but there has been no systematic attempt to summarise this. We aim to create two systematic maps that will collate the evidence for (1) the transmission of antibiotic resistance from the natural environment to humans on a global scale and (2) the state of antibiotic resistance in the environment in the United Kingdom.Search strategies were developed for each map. Searches were undertaken in 13 bibliographic databases. Key websites were searched and experts consulted for grey literature. Search results were managed using EndNote X8. Titles and abstracts were screened, followed by the full texts. Articles were double screened at a minimum of 10% at both stages with consistency checking and discussion when disagreements arose. Data extraction occurred in Excel with bespoke forms designed. Data extracted from each selected study included: bibliographic information; study site location; exposure source; exposure route; human health outcome (Map 1); prevalence/percentage/abundance of ARB/antibiotic resistance elements (Map 2) and study design. EviAtlas was used to visualise outputs.For Map 1, 40 articles were included, from 11,016 unique articles identified in searches, which investigated transmission of AMR from the environment to humans. Results from Map 1 showed that consumption/ingestion was the most studied transmission route. Exposure (n = 17), infection (n = 16) and colonisation (n = 11) being studied as an outcome a similar number of times, with mortality studied infrequently (n = 2). In addition, E. coli was the most highly studied bacterium (n = 16). For Map 2, we included 62 studies quantifying ARB or resistance elements in the environment in the UK, from 6874 unique articles were identified in the searches. The most highly researched species was mixed communities (n = 32). The most common methodology employed in this research question was phenotypic testing (n = 37). The most commonly reported outcome was the characterisation of ARBs (n = 40), followed by characterisation of ARGs (n = 35). Other genetic elements, such as screening for intI1 (n = 15) (which encodes a Class 1 integron which is used as a proxy for environmental ARGs) and point mutations (n = 1) were less frequently reported. Both maps showed that research was focused towards aquatic environments.Both maps can be used by policy makers to show the global (Map 1) and UK (Map 2) research landscapes and provide an overview of the state of AMR in the environment and human health impacts of interacting with the environment. We have also identified (1) clusters of research which may be used to perform meta-analyses and (2) gaps in the evidence base where future primary research should focus.The online version contains supplementary material available at 10.1186/s13750-022-00262-2.

To assess what is known about the effectiveness, safety, affordability, cost-effectiveness and organisational impact of endoscopic surveillance in preventing morbidity and mortality from adenocarcinoma in patients with Barrett's oesophagus. In addition, to identify important areas of uncertainty in current knowledge for these programmes and to identify areas for further research.Electronic databases up to March 2004. Experts in Barrett's oesophagus from the UK.A systematic review of the effectiveness of endoscopic surveillance of Barrett's oesophagus was carried out following methodological guidelines. Experts in Barrett's oesophagus from the UK were invited to contribute to a workshop held in London in May 2004 on surveillance of Barrett's oesophagus. Small group discussion, using a modified nominal group technique, identified key areas of uncertainty and ranked them for importance. A Markov model was developed to assess the cost-effectiveness of a surveillance programme for patients with Barrett's oesophagus compared with no surveillance and to quantify important areas of uncertainty. The model estimates incremental cost--utility and expected value of perfect information for an endoscopic surveillance programme compared with no surveillance. A cohort of 1000 55-year-old men with a diagnosis of Barrett's oesophagus was modelled for 20 years. The base case used costs in 2004 and took the perspective of the UK NHS. Estimates of expected value of information were included.No randomised controlled trials (RCTs) or well-designed non-randomised controlled studies were identified, although two comparative studies and numerous case series were found. Reaching clear conclusions from these studies was impossible owing to lack of RCT evidence. In addition, there was incomplete reporting of data particularly about cause of death, and changes in surveillance practice over time were mentioned but not explained in several studies. Three cost--utility analyses of surveillance of Barrett's oesophagus were identified, of which one was a further development of a previous study by the same group. Both sets of authors used Markov modelling and confined their analysis to 50- or 55-year-old white men with gastro-oesophageal reflux disease (GORD) symptoms. The models were run either for 30 years or to age 75 years. As these models are American, there are almost certainly differences in practice from the UK and possible underlying differences in the epidemiology and natural history of the disease. The costs of the procedures involved are also likely to be very different. The expert workshop identified the following key areas of uncertainty that needed to be addressed: the contribution of risk factors for the progression of Barrett's oesophagus to the development of high-grade dysplasia (HGD) and adenocarcinoma of the oesophagus; possible techniques for use in the general population to identify patients with high risk of adenocarcinoma; effectiveness of treatments for Barrett's oesophagus in altering cancer incidence; how best to identify those at risk in order to target treatment; whether surveillance programmes should take place at all; and whether there are clinical subgroups at higher risk of adenocarcinoma. Our Markov model suggests that the base case scenario of endoscopic surveillance of Barrett's oesophagus at 3-yearly intervals, with low-grade dysplasia surveyed yearly and HGD 3-monthly, does more harm than good when compared with no surveillance. Surveillance produces fewer quality-adjusted life-years (QALYs) for higher cost than no surveillance, therefore it is dominated by no surveillance. The cost per cancer identified approaches pound 45,000 in the surveillance arm and there is no apparent survival advantage owing to high recurrence rates and increased mortality due to more oesophagectomies in this arm. Non-surveillance continues to cost less and result in better quality of life whatever the surveillance intervals for Barrett's oesophagus and dysplastic states and whatever the costs (including none) attached to endoscopy and biopsy as the surveillance test. The probabilistic analyses assess the overall uncertainty in the model. According to this, it is very unlikely that surveillance will be cost-effective even at relatively high levels of willingness to pay. The simulation showed that, in the majority of model runs, non-surveillance continued to cost less and result in better quality of life than surveillance. At the population level (i.e. people with Barrett's oesophagus in England and Wales), a value of pound 6.5 million is placed on acquiring perfect information about surveillance for Barrett's oesophagus using expected value of perfect information (EVPI) analyses, if the surveillance is assumed to be relevant over 10 years. As with the one-way sensitivity analyses, the partial EVPI highlighted recurrence of adenocarcinoma of the oesophagus (ACO) after surgery and time taken for ACO to become symptomatic as particularly important parameters in the model.The systematic review concludes that there is insufficient evidence available to assess the clinical effectiveness of surveillance programmes of Barrett's oesophagus. There are numerous gaps in the evidence, of which the lack of RCT data is the major one. The expert workshop reflected these gaps in the range of topics raised as important in answering the question of the effectiveness of surveillance. Previous models of cost-effectiveness have most recently shown that surveillance programmes either do more harm than good compared with no surveillance or are unlikely to be cost-effective at usual levels of willingness to pay. Our cost--utility model has shown that, across a range of values for the various parameters that have been chosen to reflect uncertainty in the inputs, it is likely that surveillance programmes do more harm than good -- costing more and conferring lower quality of life than no surveillance. Probabilistic analysis shows that, in most cases, surveillance does more harm and costs more than no surveillance. It is unlikely, but still possible, that surveillance may prove to be cost-effective. The cost-effectiveness acceptability curve, however, shows that surveillance is unlikely to be cost-effective at either the 'usual' level of willingness to pay ( pound 20,000-30,000 per QALY) or at much higher levels. The expected value of perfect information at the population level is pound 6.5 million. Future research should target both the overall effectiveness of surveillance and the individual elements that contribute to a surveillance programme, particularly the performance of the test and the effectiveness of treatment for both Barrett's oesophagus and ACO. In addition, of particular importance is the clarification of the natural history of Barrett's oesophagus.

Background Functional endoscopic sinus surgery (FESS) has been used for &gt;20 years for the management of sinus disease including the excision of nasal polyps. Our objective was to perform a systematic review of safety and effectiveness of FESS for the removal of nasal polyps. Methods The Cochrane Library, MEDLINE, Embase, Science Citation Index, other databases, and websites were searched in January and December 2005 using key words for nasal polyps and endoscopic surgery. All randomized controlled trials, nonrandomized comparative studies, and case series studies that described outcomes associated with FESS for the excision of nasal polyps were included. Forty-two publications were included from the 632 (6.6%) articles initially identified. Two reviewers assessed validity of included studies and extracted relevant data. Results Three randomized controlled trials, 4 nonrandomized comparative studies, and 35 case series studies were included in the review. FESS was compared with endoscopic polypectomy, Caldwell-Luc, radical nasalization, and intranasal ethmoidectomy. In general, studies were of poor quality and lacked description of important variables influencing surgical outcome. Overall complications for FESS from case series studies ranged from 0.3 to 22.4% (median, 7.0%). Major complications ranged from 0 to 1.5% (median, 0%) and minor complications ranged from 1.1 to 20.8% (median, 7.5%). The potentially most serious complications were cerebrospinal fluid leaks, injury to the internal carotid artery, dural exposure, meningitis, bleeding requiring transfusion, periorbital/orbital fat exposure, and orbital penetration. Symptomatic improvement ranged from 78 to 88% for FESS compared with 43 to 84% for comparative procedures. From case series, symptomatic improvement ranged from 40 to 98% (median, 88%). Conclusion FESS may offer some advantages in safety and effectiveness over comparative techniques, but wide variation in reported results and methodological shortcomings of studies limit the certainty of these conclusions. Wide variation in complication rates suggests the need for audit of existing practice. Additional high-quality studies with a fuller description of potential confounding factors and effect modifiers will help to define the effectiveness of FESS more clearly.

To provide an evidence-based perspective on the prognostic value of novel markers in localised prostate cancer and to identify the best prognostic model including the three classical markers and investigate whether models incorporating novel markers are better.Eight electronic bibliographic databases were searched during March-April 2007. The reference lists of relevant articles were checked and various health services research-related resources consulted via the internet. The search was restricted to publications from 1970 onwards in the English language.Selected studies were assessed, data extracted using a standard template, and quality assessed using an adaptation of published criteria. Because of the heterogeneity regarding populations, outcomes and study type, meta-analyses were not undertaken and the results are presented in tabulated format with a narrative synthesis of the results.In total 30 papers met the inclusion criteria, of which 28 reported on prognostic novel markers and five on prognostic models. A total of 21 novel markers were identified from the 28 novel marker studies. There was considerable variability in the results reported, the quality of the studies was generally poor and there was a shortage of studies in some categories. The marker with the strongest evidence for its prognostic significance was prostate-specific antigen (PSA) velocity (or doubling time). There was a particularly strong association between PSA velocity and prostate cancer death in both clinical and pathological models. In the clinical model the hazard ratio for death from prostate cancer was 9.8 (95% CI 2.8-34.3, p < 0.001) in men with an annual PSA velocity of more than 2 ng/ml versus an annual PSA velocity of 2 ng/ml or less; similarly, the hazard ratio was 12.8 (95% CI 3.7-43.7, p < 0.001) in the pathological model. The quality of the prognostic model studies was adequate and overall better than the quality of the prognostic marker studies. Two issues were poorly dealt with in most or all of the prognostic model studies: inclusion of established markers and consideration of the possible biases from study attrition. Given the heterogeneity of the models, they cannot be considered comparable. Only two models did not include a novel marker, and one of these included several demographic and co-morbidity variables to predict all-cause mortality. Only two models reported a measure of model performance, the C-statistic, and for neither was it calculated in an external data set. It was not possible to assess whether the models that included novel markers performed better than those without.This review highlighted the poor quality and heterogeneity of studies, which render much of the results inconclusive. It also pinpointed the small proportion of models reported in the literature that are based on patient cohorts with a mean or median follow-up of at least 5 years, thus making long-term predictions unreliable. PSA velocity, however, stood out in terms of the strength of the evidence supporting its prognostic value and the relatively high hazard ratios. There is great interest in PSA velocity as a monitoring tool for active surveillance but there is as yet no consensus on how it should be used and, in particular, what threshold should indicate the need for radical treatment.

Too many studies go unread. Collate them to enable synthesis and guide decision-making in sustainability, urge Madeleine C. McKinnon and colleagues.

Objectives: Licensing of, and coverage decisions on, new therapies should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may not only expedite the regulatory approval of new therapies but also inform coverage decisions. It is, therefore, essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how the evidence thus derived should be applied by policy makers. Methods: We review current statistical approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumor settings. We assessed the suitability of two surrogates (progression-free survival [PFS] and time-to-progression [TTP]) using three current validation frameworks: Elston and Taylor's framework, the German Institute of Quality and Efficiency in Health Care's (IQWiG) framework and the Biomarker-Surrogacy Evaluation Schema (BSES3). Results: A wide variety of statistical methods have been used to assess surrogacy. The strength of the association between the two surrogates and OS was generally low. The level of evidence (observation-level versus treatment-level) available varied considerably by cancer type, by evaluation tools and was not always consistent even within one specific cancer type. Conclusions: Not in all solid tumors the treatment-level association between PFS or TTP and OS has been investigated. According to IQWiG's framework, only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents. Our study emphasizes the challenges of surrogate-endpoint validation and the importance of building consensus on the development of evaluation frameworks.

Background Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by age-inappropriate levels of inattention, impulsivity and hyperactivity. School can be particularly challenging for children with ADHD. Few reviews have considered non-pharmacological interventions in school settings. Objectives To assess the effectiveness of non-pharmacological interventions delivered in school settings for pupils with, or at risk of, ADHD and to explore the factors that may enhance, or limit, their delivery. Data sources Twenty electronic databases (including PsycINFO, MEDLINE, EMBASE, Education Resources Information Centre, The Cochrane Library and Education Research Complete) were searched from 1980 to February–August 2013. Three separate searches were conducted for four systematic reviews; they were supplemented with forward and backwards citation chasing, website searching, author recommendations and hand-searches of key journals. Review methods The systematic reviews focused on (1) the effectiveness of school-based interventions for children with or at risk of ADHD; (2) quantitative research that explores attitudes towards school-based non-pharmacological interventions for pupils with ADHD; (3) qualitative research investigating the attitudes and experiences of children, teachers, parents and others using ADHD interventions in school settings; and (4) qualitative research exploring the experience of ADHD in school among pupils, their parents and teachers more generally. Methods of synthesis included a random-effects meta-analysis, meta-regression and narrative synthesis for review 1, narrative synthesis for review 2 and meta-ethnography and thematic analysis for reviews 3 and 4. Results For review 1, 54 controlled trials met the inclusion criteria. For the 36 meta-analysed randomised controlled trials, beneficial effects ( p &lt; 0.05) were observed for several symptom and scholastic outcomes. Mean weighted effect sizes ranged from very small ( d + &lt; 0.20) to large ( d + ≥ 0.80), but substantial heterogeneity in effect size estimates across studies was reported. Moderator analyses were not able to clarify which intervention features were linked with effectiveness. For review 2, 28 included studies revealed that educators’ attitudes towards interventions ranged in positivity. Most interventions were rated positively or neutrally across different studies. The only intervention that consistently recorded positive attitudes from educators was daily report cards. For review 3, 33 studies met the inclusion criteria. Key findings included tensions regarding the preferred format of interventions, particularly how structured interventions were and the extent to which they are tailored to the child with ADHD. There were mixed views about the impact of interventions, although it was clear that interventions both influence and are influenced by the relationships held by children with ADHD and participants’ attitudes towards school and ADHD. For review 4, 34 studies met the inclusion criteria. Key findings included the importance of causal attributions that teachers, parents and pupils made about ADHD symptoms, the decisions teachers made about treatment, the self-perceptions pupils developed about themselves, the role of the classroom environment and stigma in aggravating ADHD symptoms, and the significant barrier to treatment posed by the common presence of conflict in relationships between pupils–teachers, parents–teachers and pupils–peers in relation to ADHD. An overarching synthesis of the four reviews highlighted the importance of the context affecting interventions. It suggested that ADHD psychoeducation and relationship-building skills are potential implications for interventions. Limitations The breadth of both interventions and outcomes in the reviewed studies presented a challenge for categorisation, analysis and interpretation in reviews 1–3. Across reviews, relatively few studies were conducted in the UK, limiting the applicability of findings to UK education. In reviews 1 and 2, the poor methodological quality of some included studies was identified as a barrier to establishing effectiveness or comparing attitudes. In review 3 the descriptive analysis used by the majority of studies constrained theorising during synthesis. Studies in review 4 lacked detail regarding important issues like gender, pupil maturity and school level. Conclusion Findings suggest some beneficial effects of non-pharmacological interventions for ADHD used in school settings, but substantial heterogeneity in effect sizes was seen across studies. The qualitative reviews demonstrate the importance of the context in which interventions are used. Future work should consider more rigorous evaluation of interventions, as well as focus on what works, for whom and in which contexts. Gaps in current research present opportunities for the development and testing of standardised tools to describe interventions, agreement on gold-standard outcome measures assessing ADHD behaviour and testing a range of potential moderators alongside intervention trials. Study registration This study is registered as PROSPERO CRD42011001716. Funding The National Institute for Health Research Health Technology Assessment programme.

There is growing research and policy interest in the potential for using the natural environment to enhance human health and well-being. This resource may be underused as a health promotion tool to address the increasing burden of common health problems such as increased chronic diseases and mental health concerns. Outdoor environmental enhancement and conservation activities (EECA) (for instance unpaid litter picking, tree planting or path maintenance) offer opportunities for physical activity alongside greater connectedness with local environments, enhanced social connections within communities and improved self-esteem through activities that improve the locality which may, in turn, further improve well-being.To assess the health and well-being impacts on adults following participation in environmental enhancement and conservation activities.We contacted or searched the websites of more than 250 EECA organisations to identify grey literature. Resource limitations meant the majority of the websites were from UK, USA, Canada and Australia. We searched the following databases (initially in October 2012, updated October 2014, except CAB Direct, OpenGrey, SPORTDiscus, and TRIP Database), using a search strategy developed with our project advisory groups (predominantly leaders of EECA-type activities and methodological experts): ASSIA; BIOSIS; British Education Index; British Nursing Index; CAB Abstracts; Campbell Collaboration; Cochrane Public Health Specialized Register; DOPHER; EMBASE; ERIC; Global Health; GreenFILE; HMIC; MEDLINE-in-Process; MEDLINE; OpenGrey; PsychINFO; Social Policy and Practice; SPORTDiscus; TRoPHI; Social Services Abstracts; Sociological Abstracts; The Cochrane Library; TRIP database; and Web of Science. Citation and related article chasing was used. Searches were limited to studies in English published after 1990.Two review authors independently screened studies. Included studies examined the impact of EECA on adult health and well-being. Eligible interventions needed to include each of the following: intended to improve the outdoor natural or built environment at either a local or wider level; took place in urban or rural locations in any country; involved active participation; and were NOT experienced through paid employment.We included quantitative and qualitative research. Includable quantitative study designs were: randomised controlled trials (RCTs), cluster RCTs, quasi-RCTs, cluster quasi-RCTs, controlled before-and-after studies, interrupted-time-series, cohort studies (prospective or retrospective), case-control studies and uncontrolled before-and-after studies (uBA). We included qualitative research if it used recognised qualitative methods of data collection and analysis.One reviewer extracted data, and another reviewer checked the data. Two review authors independently appraised study quality using the Effective Public Health Practice Project tool (for quantitative studies) or Wallace criteria (for qualitative studies). Heterogeneity of outcome measures and poor reporting of intervention specifics prevented meta-analysis so we synthesised the results narratively. We synthesised qualitative research findings using thematic analysis.Database searches identified 21,420 records, with 21,304 excluded at title/abstract. Grey literature searches identified 211 records. We screened 327 full-text articles from which we included 21 studies (reported in 28 publications): two case-studies (which were not included in the synthesis due to inadequate robustness), one case-control, one retrospective cohort, five uBA, three mixed-method (uBA, qualitative), and nine qualitative studies. The 19 studies included in the synthesis detailed the impacts to a total of 3,603 participants: 647 from quantitative intervention studies and 2630 from a retrospective cohort study; and 326 from qualitative studies (one not reporting sample size).Included studies shared the key elements of EECA defined above, but the range of activities varied considerably. Quantitative evaluation methods were heterogeneous. The designs or reporting of quantitative studies, or both, were rated as 'weak' quality with high risk of bias due to one or more of the following: inadequate study design, intervention detail, participant selection, outcome reporting and blinding.Participants' characteristics were poorly reported; eight studies did not report gender or age and none reported socio-economic status. Three quantitative studies reported that participants were referred through health or social services, or due to mental ill health (five quantitative studies), however participants' engagement routes were often not clear.Whilst the majority of quantitative studies (n = 8) reported no effect on one or more outcomes, positive effects were reported in six quantitative studies relating to short-term physiological, mental/emotional health, and quality-of-life outcomes. Negative effects were reported in two quantitative studies; one study reported higher levels of anxiety amongst participants, another reported increased mental health stress.The design or reporting, or both, of the qualitative studies was rated as good in three studies or poor in nine; mainly due to missing detail about participants, methods and interventions. Included qualitative evidence provided rich data about the experience of participation. Thematic analysis identified eight themes supported by at least one good quality study, regarding participants' positive experiences and related to personal/social identity, physical activity, developing knowledge, spirituality, benefits of place, personal achievement, psychological benefits and social contact. There was one report of negative experiences.There is little quantitative evidence of positive or negative health and well-being benefits from participating in EECA. However, the qualitative research showed high levels of perceived benefit among participants. Quantitative evidence resulted from study designs with high risk of bias, qualitative evidence lacked reporting detail. The majority of included studies were programme evaluations, conducted internally or funded by the provider.The conceptual framework illustrates the range of interlinked mechanisms through which people believe they potentially achieve health and well-being benefits, such as opportunities for social contact. It also considers potential moderators and mediators of effect.One main finding of the review is the inherent difficulty associated with generating robust evidence of effectiveness for complex interventions. We developed the conceptual framework to illustrate how people believed they benefited. Investigating such mechanisms in a subsequent theory-led review might be one way of examining evidence of effect for these activities.The conceptual framework needs further refinement through linked reviews and more reliable evidence. Future research should use more robust study designs and report key intervention and participant detail.

Despite the increased scholarly interest in the senses and sensory experiences, the topic of older people’s sensory engagement with nature is currently under researched. This paper reviews and synthesises qualitative research evidence about how older people, including those living with dementia, describe their sensory engagement with the natural world. Ten databases were searched from 1990 to September 2014: MEDLINE (Ovid), MEDLINE-in-Process (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), GreenFILE (EBSCO), ProQuest Sociology, ASSIA (ProQuest), International Bibliography of the Social Sciences (ProQuest); HMIC (Ovid); Social Policy and Practice (Ovid). Forward and backward citation chasing of included articles was conducted; 20 organizations were contacted to identify unpublished reports. Screening was undertaken independently by two reviewers. Twenty seven studies were included. Thematic analysis revealed that descriptions of sensory experiences are encompassed within six themes: descriptions from ‘the window’; sensory descriptions that emphasise vision; descriptions of ‘being in nature’; descriptions of ‘doing in nature’; barriers to sensory engagement; and meanings of being and doing in nature. Older people derive considerable pleasure and enjoyment from viewing nature, being and doing in nature which, in turn has a positive impact on their wellbeing and quality of life. Future research could usefully explore how sensory engagement with nature could be used to stimulate reminiscences of places and people, and evoke past sensory experiences to enrich everyday life and maintain a sense of self. The protocol was registered with PROSPERO ( CRD42015020736 ).

Every year, more than 800,000 people worldwide die by suicide. The aim of this study was to conduct a systematic review of the effectiveness of brief psychological interventions in addressing suicidal thoughts and behaviour in healthcare settings. Following PRISMA guidelines, systematic searches were conducted in MEDLINE, CINAHL, EMBASE, the Cochrane Central Register of Controlled Trials and PsycINFO databases. A predefined search strategy was used. Two independent reviewers screened titles and abstracts followed by full texts against predefined inclusion criteria. Backward and forward citation tracking of included papers was conducted. Quality appraisal was conducted using the Cochrane Risk of Bias Tool for Randomized Controlled Trials and the CASP tool for randomised controlled trials. The small number and heterogeneity of studies did not allow for meta-analysis to be conducted. A narrative synthesis was conducted. Four controlled studies of brief psychological interventions were included, conducted in Switzerland, the U.S. and across low and middle-income countries. Three studies were conducted with adults and one with adolescents. All studies were judged to be at low risk of bias. All of the interventions were implemented with patients after attending emergency departments and involved 3412 participants. The main outcomes were suicide, suicide attempts, suicidal ideation, depression and hospitalization. The components of the interventions were early therapeutic engagement, information provision, safety planning and follow-up contact for at least 12 months. The interventions drew to, different degrees, on psychological theory and techniques. Two trials that measured suicidal ideation found no impact. Two studies showed fewer suicide attempts, one showed fewer suicides and one found an effect on depression. Although the evidence base is small, brief psychological interventions appear to be effective in reducing suicide and suicide attempts. All studies to date have been conducted with people who had attended the ED but the interventions could potentially be adopted for inpatient and other outpatient settings. Early engagement and therapeutic intervention based on psychological theories of suicidal behaviour, sustained in follow-up contacts, may be particularly beneficial. Systematic review registration: PROSPERO CRD42015025867.

The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting.Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality.The eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes.The study, conducted from 2015 - 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes.Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance.The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.目的: 本研究的目的是为提高元人种志报告的完整性和清晰度提供指导。 背景: 基于证据的政策和实践需要强有力的证据合成,以进一步了解人们的经验和相关的社会过程。 种志是由诺伯特和黑尔开发的一种严谨的七-相定性证据综合方法。元人种志在健康研究中被广泛使用,但报告质量往往很差,这阻碍了对研究结果的信任和使用。元人种志报告指南是提高报告质量所必需的。 设计: 本研究采用了严格的混合方法设计和基于证据的方法来开发新的报告指南和注释。 方法: 这项研究从2015年到2017年进行,包括:(1)对元人种志行为和报告指南的方法系统审查;(2)审查和审计已出版的元人种志,以确定良好的实践原则;(3)国际、多学科的共识--建立过程以达成指导内容;(4)创新发展的指导和说明。 研究发现: 新确定的所有七个元人种志实施和报告阶段的建议和良好做法提供了19项报告准则,并附有详细的指南。 结论: 定制的新兴报告指南,包含了新的方法论的发展和进步,可以帮助研究人员报告元人种志的重要方面。使用指南应提高报告质量。更好的报告可以使对调查结果的信心评估更加可靠,并增加对元人种学输出的使用,以改进卫生和其他领域的实践、政策和服务用户结果。这是第一个为元人种学量身定制的报告指南。本文同时发表于《高级护理杂志》、《精神肿瘤学》、《教育评论》和《英国医学委员会医学研究方法论》等期刊。.

Background Although mental health difficulties can severely complicate the lives of children and young people (CYP) with long-term physical conditions (LTCs), there is a lack of evidence about the effectiveness of interventions to treat them. Objectives To evaluate the clinical effectiveness and cost-effectiveness of interventions aiming to improve the mental health of CYP with LTCs (review 1) and explore the factors that may enhance or limit their delivery (review 2). Data sources For review 1, 13 electronic databases were searched, including MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Science Citation Index. For review 2, MEDLINE, PsycINFO and CINAHL were searched. Supplementary searches, author contact and grey literature searches were also conducted. Review methods The first systematic review sought randomised controlled trials (RCTs) and economic evaluations of interventions to improve elevated symptoms of mental ill health in CYP with LTCs. Effect sizes for each outcome were calculated post intervention (Cohen’s d ). When appropriate, random-effects meta-analyses produced pooled effect sizes ( d ). Review 2 located primary qualitative studies exploring experiences of CYP with LTCs, their families and/or practitioners, regarding interventions aiming to improve the mental health and well-being of CYP with LTCs. Synthesis followed the principles of metaethnography. An overarching synthesis integrated the findings from review 1 and review 2 using a deductive approach. End-user involvement, including topic experts and CYP with LTCs and their parents, was a feature throughout the project. Results Review 1 synthesised 25 RCTs evaluating 11 types of intervention, sampling 12 different LTCs. Tentative evidence from seven studies suggests that cognitive–behavioural therapy interventions could improve the mental health of CYP with certain LTCs. Intervention–LTC dyads were diverse, with few opportunities to meta-analyse. No economic evaluations were located. Review 2 synthesised 57 studies evaluating 21 types of intervention. Most studies were of individuals with cancer, a human immunodeficiency virus (HIV) infection or mixed LTCs. Interventions often aimed to improve broader mental health and well-being, rather than symptoms of mental health disorder. The metaethnography identified five main constructs, described in an explanatory line of argument model of the experience of interventions. Nine overarching synthesis categories emerged from the integrated evidence, raising implications for future research. Limitations Review 1 conclusions were limited by the lack of evidence about intervention effectiveness. No relevant economic evaluations were located. There were no UK studies included in review 1, limiting the applicability of findings. The mental health status of participants in review 2 was usually unknown, limiting comparability with review 1. The different evidence identified by the two systematic reviews challenged the overarching synthesis. Conclusions There is a relatively small amount of comparable evidence for the effectiveness of interventions for the mental health of CYP with LTCs. Qualitative evidence provided insight into the experiences that intervention deliverers and recipients valued. Future research should evaluate potentially effective intervention components in high-quality RCTs integrating process evaluations. End-user involvement enriched the project. Study registration This study is registered as PROSPERO CRD42011001716. Funding The National Institute for Health Research (NIHR) Health Technology Assessment programme and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

Abstract Background Forests provide an essential resource to the livelihoods of an estimated 20% of the global population. The contribution of forest ecosystems and forest-based resources to poverty reduction is increasingly emphasized in international policy discourse and conservation and development investments. However, evidence measuring the effect of forest-based activities on poverty outcomes remains scattered and unclear. Lack of systematic understanding of forest-poverty relationships, in turn, inhibits research, policymaking, and efficient financial resource allocation. Methods To identify relevant studies for inclusion in this systematic map we searched six bibliographic databases, 15 organizational websites, eight systematic evidence syntheses (reviews and maps), and solicited information from key informants. Search results were screened for relevance against predefined inclusion criteria at title, abstract, and full text levels, according to a published protocol. Included articles were coded using a predefined framework. Trends in the evidence, knowledge gaps and relatively well-researched sub-topics are reported in a narrative synthesis. Occurrence and extent of existing evidence about links between interventions and outcomes are presented in a visual heatmap. Data are available through the open access Evidence for Nature and People Data Portal ( http://www.natureandpeopleevidence.org ). Results A total of 242 articles were included in the systematic map database. Included articles measured effects of 14 forest-based intervention types on 11 poverty dimensions. The majority of the evidence base (72%) examined links between productivity-enhancement strategies (e.g. forest management, agroforestry, and habitat management) and monetary income and/or social capital outcomes. Other areas with high occurrence of articles include linkages between interventions involving governance, individual rights/empowerment or linked enterprises/livelihood alternatives with impacts on monetary income from direct sale of goods. A key knowledge gap was on the impacts of investment-based interventions (i.e. enhancing produced, human, and social capitals). Another was the impacts of forest-based interventions on financial capital (savings, debt), non-monetary benefits, and health. Conclusions The evidence base on forest-based productive activities and poverty alleviation is growing but displays a number of biases in the distribution of articles on key linkages. Priorities for future systematic reviews and evaluations include in-depth examinations into the impacts of rights-based activities (e.g. governance, empowerment) on poverty dimensions; and productivity-enhancing activities on social capital. More comprehensive and robust evidence is needed to better understand the synergies and trade-offs among the different objectives of forest conservation and management and variation in outcomes for different social groups in different social-ecological contexts.

We aimed to map the systematic review evidence available to inform the optimal prescribing of statins and antihypertensive medication.Systematic umbrella review and evidence and gap map (EGM).Eight bibliographic databases (Cochrane Database of Systematic Reviews, CINAHL, EMBASE, Health Management Information Consortium, MEDLINE ALL, PsycINFO, Conference Proceedings Citation Index-Science and Science Citation Index) were searched from 2010 to 11 August 2020. Update searches conducted in MEDLINE ALL 2 August 2022. We searched relevant websites and conducted backwards citation chasing.We sought systematic reviews of quantitative or qualitative research where adults 16 years+ were currently receiving, or being considered for, a prescription of statin or antihypertensive medication. Eligibility criteria were applied to the title and abstract and full text of each article independently by two reviewers.Quality appraisal was completed by one reviewer and checked by a second. Review characteristics were tabulated and incorporated into an EGM based on a patient care pathway. Patients with lived experience provided feedback on our research questions and EGM.Eighty reviews were included within the EGM. The highest quantity of evidence focused on evaluating interventions to promote patient adherence to antihypertensive medication. Key gaps included a lack of reviews synthesising evidence on experiences of specific interventions to promote patient adherence or improve prescribing practice. The evidence was predominantly of low quality, limiting confidence in the findings from individual reviews.This EGM provides an interactive, accessible format for policy developers, service commissioners and clinicians to view the systematic review evidence available relevant to optimising the prescribing of statin and antihypertensive medication. To address the paucity of high-quality research, future reviews should be conducted and reported according to existing guidelines and address the evidence gaps identified above.

To estimate the effectiveness and cost-effectiveness of dual-chamber pacemakers versus single-chamber atrial or single-chamber ventricular pacemakers in the treatment of bradycardia due to sick sinus syndrome (SSS) or atrioventricular block (AVB).Electronic databases and relevant Internet sites. Contact with device manufacturers and experts in the field.A systematic review was carried out of randomised controlled trials (RCTs). The quality of selected studies was appraised using standard frameworks. Meta-analyses, using random effects models, were carried out where appropriate. Limited exploration of heterogeneity was possible. Critical appraisal of economic evaluations was carried out using two frameworks. A decision-analytic model was developed using a Markov approach, to estimate the cost-effectiveness of dual-chamber versus ventricular or atrial pacing over 5 and 10 years as cost per quality-adjusted life-year (QALY). Uncertainty was explored using one-way and probabilistic sensitivity analyses.The searches retrieved a systematic review of effectiveness and cost-effectiveness published in 2002, four parallel group RCTs and 28 cross-over trials. Dual-chamber pacing was associated with lower rates of atrial fibrillation, particularly in SSS, than ventricular pacing, and prevents pacemaker syndrome. Higher rates of atrial fibrillation were seen with dual-chamber pacing than with atrial pacing. Complications occurred more frequently in dual-chamber pacemaker insertion. The cost of a dual-chamber system, over 5 years, including cost of complications and subsequent clinical events in the population, was estimated to be around 7400 pounds. The overall cost difference between single and dual systems is not large over this period: around 700 pounds more for dual-chamber devices. The cost-effectiveness of dual-chamber compared with ventricular pacing was estimated to be around 8500 pounds per QALY in AVB and 9500 pounds in SSS over 5 years, and around 5500 pounds per QALY in both populations over 10 years. Under more conservative assumptions, the cost-effectiveness of dual-chamber pacing is around 30,000 pounds per QALY. The probabilistic sensitivity analysis showed that, under the base-case assumptions, dual-chamber pacing is likely to be considered cost-effective at levels of willingness to pay that are generally considered acceptable by policy makers. In contrast, atrial pacing may be cost-effective compared with dual-chamber pacing.Dual-chamber pacing results in small but potentially important benefits in populations with SSS and/or AVB compared with ventricular pacemakers. Pacemaker syndrome is a crucial factor in determining cost-effectiveness; however, difficulties in standardising diagnosis and measurement of severity make it difficult to quantify. Dual-chamber pacing is in common usage in the UK. Recipients are more likely to be younger. Insufficient evidence is currently available to inform policy on specific groups who may benefit most from pacing with dual-chamber devices. Further important research is underway. Outstanding research priorities include the economic evaluation of UKPACE studies of the classification, diagnosis and utility associated with pacemaker syndrome and evidence on the effectiveness of pacemakers in children.

To provide a systematic review of the clinical effectiveness of endoscopic sinus surgery (ESS) for the removal of nasal polyps.Searches of electronic databases, websites and reference lists were made to identify relevant studies.An extensive search was performed to identify all articles where FESS is used for the excision of nasal polyps. Two reviewers independently screened articles for inclusion according to predefined criteria. Comparative studies were included if they were primary research, focused on FESS for the removal of nasal polyps, reported patient relevant outcomes and were published in English. In addition, case series studies were included if they met the above criteria and enrolled more than 50 patients with polyps. Data were then extracted by one reviewer and checked by a second. A structured form was used to assess the internal and external validity of included studies. Comparative data were reported where available. Excluded case series and case reports were grouped and described. A group of nine ear, nose and throat (ENT) experts were selected, then using the literature and their own experience, they generated a list of priority research questions. Existing economic evaluations were sought and described.Of the 33 studies included, the randomised controlled trials and controlled trials reported overall symptomatic improvement that ranged from 78 to 88% for FESS compared with 43 to 84% for similar techniques (including polypectomy, Caldwell-Luc and intranasal ethmoidectomy). Disease recurrence was 8% for FESS compared with 14% for Caldwell-Luc and polyp recurrence was 28% for endoscopic ethmoidectomy compared with 35% for polypectomy. Revision surgery was reported in one study only and was the same for FESS and Caldwell-Luc procedures. Percentage of overall complications was reported in only one comparative study and was 1.4% for FESS compared with 0.8% for conventional procedures. The case series studies reported overall symptomatic improvement for patients with nasal polyps ranging from 37 to 99% (median 89%). For the mixed patient groups (with and without polypoid disease) overall symptomatic improvement ranged from 40 to 98% (median 88%). Total complications in the case series studies ranged from 22.4 to 0.3% (median 6%).The majority of studies report that symptoms improve following FESS with relatively few complications; however, only a small proportion of evidence is comparative. Results from non-comparative studies do not inform the choices that need to be made by ENT surgeons and commissioners. Health economics data are also lacking and therefore cannot inform these decisions. FESS may offer some advantages in effectiveness over comparative techniques, but there is enormous variation in the range of results reported and there are severe methodological limitations. There is a clear need for quality-controlled trials in order to answer questions regarding the effectiveness of FESS. A number of priority research questions from a selection of ENT surgeons within the UK are identified and presented.

The HTA Programme was set up in 1993.Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS.'Health technologies' are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care, rather than settings of care.The HTA programme commissions research only on topics where it has identified key gaps in the evidence needed by the NHS.Suggestions for topics are actively sought

The HTA Programme was

To assess the clinical and cost-effectiveness of adjuvant carmustine wafers (BCNU-W) and also of adjuvant and concomitant temozolomide (TMZ), compared with surgery with radiotherapy.Electronic databases were searched up to August 2005.Included trials were critically appraised for key elements of internal and external validity. Relevant data were extracted and a narrative synthesis of the evidence produced. Where possible, data on absolute survival at a fixed time point were meta-analysed using a random effects model. A Markov (state transition) model was developed to assess the cost-utility of the two interventions. The model compared BCNU-W or TMZ separately with current standard treatment with surgery and radiotherapy. The simulated cohort had a mean age of 55 years and was modelled over 5 years.Two randomised controlled trials (RCTs) (n = 32, n = 240) and two observational studies of BCNU-W compared with placebo wafers as adjuvant therapy to surgery and radiotherapy for newly diagnosed high-grade glioma were identified. All the studies were in adults and provided data on 193 patients who had received BCNU-W. The RCT findings excluded under 65-year-olds and those with a Karnofsky Performance Status of less than 60. The largest multi-centre RCT suggested a possible survival advantage with BCNU-W among a cohort of patients with grade III and IV tumours, adding a median of 2.3 months [95% confidence interval (CI) -0.5 to 5.1]. However, analysis using per-protocol, unstratified methods shows this difference to be not statistically significant (HR 0.77, 95% CI 0.57 to 1.03, p = 0.08). Long-term follow-up suggests a significant survival advantage using unstratified analysis. No difference in progression-free survival (PFS) was demonstrated. Subgroup analysis of those with grade IV tumours also showed no significant survival advantage with BCNU-W [hazard ratio (HR) 0.82, 95% CI 0.55 to 1.11, p = 0.20, unstratified analysis]. It is estimated that the cost of surgery and radiotherapy, with follow-up, treatment of adverse effects and end of life care is around 17,000 pounds per patient. Treatment with BCNU-W adds an additional 6600 pounds. Across the modelled cohort of 1000 patients, use of BCNU-W costs an additional 6.6 million pounds and confers an additional 122 quality-adjusted life-years (QALYs). On average, that is 6600 pounds per patient for 0.122 QALYs (6.3 quality-adjusted life-weeks). The base-case incremental cost-effectiveness ratio (ICER) is 54,500 pounds/QALY. In probabilistic sensitivity analyses, BCNU-W was not cost-effective in 89% of the simulations assuming a willingness to pay threshold of 30,000 pounds/QALY. In 15% of simulations, BCNU-W was dominated (i.e. did more harm than good, conferring fewer QALYs at greater cost). The cost-effectiveness acceptability curve (CEAC) suggests that it is very unlikely to be the most cost-effective option at normal levels of willingness to pay (11% probability at 30,000 pounds/QALY), only becoming likely to be the most cost-effective option at much higher levels of willingness to pay (50% probability at 55,000 pounds/QALY). Two RCTs (n = 130, n = 573) and two observational studies were included, giving evidence for 429 adult patients receiving TMZ. Currently, TMZ is licensed for use in those with newly diagnosed grade IV gliomas only. The RCTs excluded those with lower performance status and, in the larger RCT, those older than 70 years. TMZ provides a small but statistically significant median survival benefit of 2.5 months (95% CI 2.0 to 3.8), giving an HR of 0.63 (95% CI 0.52 to 0.75, p < 0.001). At 2 years, 26.5% of patients treated with TMZ were alive compared with 10.4% of those in the control arm. Median PFS is also enhanced with TMZ, giving a median 1.9 months' advantage (95% CI 1.4 to 2.7, p < 0.001). No analysis of the subgroup of patients with confirmed grade IV tumours was undertaken. Subgroup analysis of patients by O6-methylguanine-DNA methyltransferase (MGMT) activity showed a significant treatment advantage for those with reduced MGMT activity but not for those with normal activity, although this analysis was based on a selected sample of patients and the test used has proved difficult to replicate. A median gain of 6.4 (95% CI 4.4 to 9.5) more life-months is seen with TMZ among those with reduced MGMT, giving an HR of 0.51 (p < 0.007). PFS is increased by a median of 4.4 months (95% CI 1.2 to 6.3), giving an HR of 0.48 (p = 0.001). The model shows a cost per patient for being treated with surgery, radiotherapy and including adverse effects of treatment and end of life care of around 17,000 pounds per patient. TMZ in the adjuvant and concomitant phase adds an additional cost of around 7800 pounds. Across the modelled cohort of 1000 patients, use of TMZ costs an additional 7.8 million pounds and confers an additional 217 QALYs. For the average patient this is 7800 pounds for an additional 0.217 QALYs (11 quality-adjusted life-weeks). The base-case ICER is 36,000 pounds/QALY. Probabilistic sensitivity analyses shows that TMZ was not cost-effective in 77% of the simulations. The CEAC suggests that there is a 23% chance that TMZ is the most cost-effective option at a willingness to pay level of 30,000 pounds/QALY, rising to be more cost-effective than no TMZ at slightly higher levels (50% probability at 35,000 pounds/QALY).BCNU-W has not been proven to confer a significant advantage in survival for patients with grade III tumours when treated with the drug, compared with placebo. There does not appear to be a survival advantage for patients with grade IV tumours. No increase in PFS has been shown. Limited evidence suggests a small but significant advantage in both overall survival and PFS with TMZ among a mixed population with grade IV and grade III (7-8%) tumours. However, it remains unclear whether this is true in grade IV tumours alone. On the basis of best available evidence, the authors consider that neither BCNU-W nor TMZ is likely to be considered cost-effective by NHS decision-makers. However, data for the model were drawn from limited evidence of variable quality. Tumour type is clearly important in assessing patient prognosis with different treatments. Grade IV tumours are commonest and appear to have least chance of response. There were too few grade III tumours included to carry out a formal assessment, but they appear to respond better and drive results for both drugs. Future use of genetic and biomarkers may help identify subtypes which will respond, but current licensing indications do not specify these. Further research is suggested into the effectiveness of these drugs, and also into areas such as genetic markers, chemotherapy regimens, patient and carer quality of life, and patient views on survival advantages vs treatment disadvantages.

This review considers barriers to, and facilitators of, success for interventions to reduce unintentional injury to children in the home through supply and/or installation of home safety equipment, and looks at risk assessments.A systematic review of qualitative research. Bibliographic databases were searched for studies on interventions to reduce unintentional child injury in the home, or on related attitudes and behaviours. Studies were quality appraised, findings extracted, and a conceptual framework was developed to assess factors affecting the success of interventions.Nine peer-reviewed journal articles were included. Barriers and facilitators were highlighted at organisational, environmental and personal levels. Effective provision of safety equipment involves ongoing support with installation and maintenance. Take up and success of interventions depends on adjusting interventions according to practical limitations and parents' cultural expectations. A particular barrier was parents' inability to modify rented or shared accommodation.The review highlights ways in which health inequalities affect the take up and success of home safety interventions, and how health workers can use this knowledge to facilitate future interventions.

Standard treatment for high grade glioma (HGG) usually entails surgery (either biopsy or resection) followed by radiotherapy plus or minus temozolomide. Implanting wafers impregnated with chemotherapy agents into the resection cavity represents a novel means of delivering drugs directly to the resection cavity with potentially fewer systemic side effects. It is not clear how effective this modality is or whether it should be recommended as part of standard care for patients with HGG.To estimate the clinical effectiveness of chemotherapy wafers for patients with HGG.The following databases were searched: CENTRAL (issue 4. 2010); MEDLINE and EMBASE. The original search strategy also included: Science Citation Index; Physician Data Query; and the meta-Register of Controlled Trials. Reference lists of all identified studies were searched. The Journal of Neuro-Oncology and Neuro-oncology were hand searched from 1999 to 2010, including all conference abstracts. Neuro-oncologists, trial authors and drug manufacturers were contacted regarding ongoing and unpublished trials.Patients included those of all ages with a histologically proven diagnosis of HGG (using intra-operative analysis when undergoing first resection). Therapy could be instigated for either newly diagnosed disease (primary therapy) or at recurrence. Interventions included insertion of chemotherapy wafers to the resection cavity. Included studies had to be randomised controlled trials (RCTs).Two independent review authors assessed the search results for relevance and undertook critical appraisal according to pre-specified guidelines.In primary disease two RCTs assessing the effect of carmustine impregnated wafers (Gliadel®) and enrolling a total of 272 participants were identified. Survival was increased with Gliadel® compared to placebo (hazard ratio (HR) 0.65, 95% Confidence Interval (CI) 0.48 to 0.86, P = 0.003). In recurrent disease a single RCT was included comparing Gliadel® with placebo and enrolled 222 participants. It did not demonstrate a significant survival increase (HR 0.83, 95% CI 0.62 to 1.10, P = 0.2). There was no suitable data for any of the secondary outcome measures. Adverse events were not more common in either arm and are presented in a descriptive fashion.Carmustine impregnated wafers (Gliadel®) result in improved survival without an increased incidence of adverse events over placebo wafers when used for primary disease therapy. There is no evidence of benefit for any other outcome measures. In recurrent disease Gliadel® does not appear to confer any additional benefit.

To identify the psychological effects of false-positive screening mammograms in the UK.Systematic review of all controlled studies and qualitative studies of women with a false-positive screening mammogram. The control group participants had normal mammograms. All psychological outcomes including returning for routine screening were permitted. All studies had a narrative synthesis.The searches returned seven includable studies (7/4423). Heterogeneity was such that meta-analysis was not possible. Studies using disease-specific measures found that, compared to normal results, there could be enduring psychological distress that lasted up to 3 years; the level of distress was related to the degree of invasiveness of the assessment. At 3 years the relative risks were, further mammography, 1.28 (95% CI 0.82 to 2.00), fine needle aspiration 1.80 (95% CI 1.17 to 2.77), biopsy 2.07 (95% CI 1.22 to 3.52) and early recall 1.82 (95% CI 1.22 to 2.72). Studies that used generic measures of anxiety and depression found no such impact up to 3 months after screening. Evidence suggests that women with false-positive mammograms have an increased likelihood of failing to reattend for routine screening, relative risk 0.97 (95% CI 0.96 to 0.98) compared with women with normal mammograms.Having a false-positive screening mammogram can cause breast cancer-specific distress for up to 3 years. The degree of distress is related to the invasiveness of the assessment. Women with false-positive mammograms are less likely to return for routine assessment than those with normal ones.

Community gardening is defined by its shared nature; gardeners work collectively to manage a garden for shared benefit. Although communal gardening activities, and recognition of their perceived benefits have a long history, it is in recent years that interest has developed in assessing the potential of the approach to address many of the threats to health and wellbeing faced by global populations. Community gardening may address chronic and non-communicable disease through the provision of opportunities for physical activity, improved nutrition and reduced stress. Participation in the gardening activities may improve wellbeing through increased social contact, culturally valued activities and mitigation of food poverty. The benefits of community gardening are argued to extend beyond the participants themselves through more coherent and cohesive communities, improved physical environments and the sharing of the products of the labour. While there are many claims made and an emerging body of research, no previous systematic review has sought to identify and synthesise the evidence in a global context. The objectives of the mixed method systematic review are to understand the health and wellbeing impacts of active participation in community gardening. Both quantitative and qualitative evidence will be sought using a broad and diverse search strategy to address the four review questions: 1) does active involvement in community gardening lead to improved health or wellbeing; 2) if so, how does active involvement in community gardening affect health and wellbeing; 3) are there different impacts for different population groups (for instance according to age, socio-economic status or sex); and 4) do different types of community gardening (for example producing vegetables or a flower garden) or in different contexts have different types of impacts? A theoretical framework, informed by an initial theory of change model, will illustrate the outcomes of participation and any mechanisms of action (i.e. how such impacts are achieved). The synthesis will be sensitive to factors which may affect the impacts, such as the context of the activities, the demographics of participants, and the implementation and specifics of the community gardening interventions.

Qualitative research on self-management for people with Type 2 Diabetes Mellitus (T2DM) has typically reported one-off retrospective accounts of individuals' strategies. The aim of this research was to identify the ways in which self-management strategies are perceived by people with T2DM as being either supportive or unsupportive over time, by using qualitative findings from both longitudinal intervention studies and usual care.A systematic review of qualitative literature, published between 2000 and 2013, was conducted using a range of searching techniques. 1374 prospective qualitative papers describing patients' experiences of self-management strategies for T2DM were identified and screened. Of the 98 papers describing qualitative research conducted in the UK, we identified 4 longitudinal studies (3 intervention studies, 1 study of usual care). Key concepts and themes were extracted, reviewed and synthesised using meta-ethnography techniques.Aspects of self-management strategies in clinical trials (e.g. supported exercise regimens) can be perceived as enabling the control of biomarkers and facilitative of quality of life. In contrast, aspects of self-management strategies outwith trial conditions (e.g. self-monitoring) can be perceived of as negative influences on quality of life. For self-management strategies to be sustainable in the long term, patients require a sense of having a stake in their management that is appropriate for their beliefs and perceptions, timely information and support, and an overall sense of empowerment in managing their diabetes in relation to other aspects of their life. This enables participants to develop flexible diabetes management strategies that facilitate quality of life and long term medical outcomes.This synthesis has explored how patients give meaning to the experiences of interventions for T2DM and subsequent attempts to balance biomarkers with quality of life in the long term. People with T2DM both construct and draw upon causal accounts as a resource, and a means to counter their inability to balance medical outcomes and quality of life. These accounts can be mediated by the provision of timely and tailored information and support over time, which can allow people to develop a flexible regimen that can facilitate both quality of life and medical outcomes.

To quantify and compare the treatment effects on three surrogate end points, progression-free survival (PFS), time to progression (TTP), and tumor response rate (TR) vs. overall survival (OS) based on a meta-analysis of randomized controlled trials (RCTs) of drug interventions in advanced colorectal cancer (aCRC).We systematically searched for RCTs of pharmacologic therapies in aCRC between 2003 and 2013. Trial characteristics, risk of bias, and outcomes were recorded based on a predefined form. Univariate and multivariate random-effects meta-analyses were used to estimate pooled summary treatment effects. The ratio of hazard ratios (HRs)/odds ratios (ORs) and difference in medians were used to quantify the degree of difference in treatment effects on the surrogate end points and OS. Spearman ρ, surrogate threshold effect (STE), and R(2) were also estimated across predefined trial-level covariates.We included 101 RCTs. In univariate and multivariate meta-analyses, we found larger treatment effects for the surrogates than for OS. Compared with OS, treatment effects were on average 13% higher when HRs were measured and 3% to 45% higher when ORs were considered; differences in median PFS/TTP were higher than on OS by an average of 0.5 month. Spearman ρ ranged from 0.39 to 0.80, mean R(2) from 0.06 to 0.65, and STE was 0.8 for HRPFS, 0.64 for HRTTP, or 0.28 for ORTR. The stratified analyses revealed high variability across all strata.None of the end points in this study were found to achieve the level of evidence (ie, mean R(2)trial > 0.60) that has been set to select high or excellent correlation levels by common surrogate evaluation tools. Previous surrogacy relationships observed between PFS and TTP vs. OS in selected settings may not apply across other classes or lines of therapy.

The use of non-drug, non-health-service interventions has been proposed as a cost-effective alternative to help those with long-term conditions manage their illness and improve their health and well-being. Interventions typically involve accessing activities run by the third sector or community agencies and may also be described as non-medical referral, community referral or social prescribing. To be effective, patients need to be "transferred" from the primary care setting into the community and to maintain their participation in activities. However, it is not currently known how and why these approaches enable which people under what circumstances to reach community services that may benefit their health and well-being.Database searches and extensive searching of grey sources will be carried out in an attempt to find evidence associated with referral and retention in social prescribing. After initial scoping searches, two main phases of searching will be conducted: (a) will focus on the identification of programme theories to illustrate how approaches to social prescribing work for different people and in different contexts and (b) will consist of targeted searches to locate evidence to refine these candidate theories into configurations of the contexts in which populations and the main mechanisms outcomes are achieved. Inclusion criteria will initially be broad in order to develop a clear picture of the ways in which social prescriptions might operate but may iteratively become more focused in response to initially identified evidence, for example, in terms of the population group. An expert advisory group consisting of professionals working in a range of organisations involved in social prescribing will be convened to check the approaches in the review and provide real-life experience of social prescribing. Findings from the review will be disseminated to commissioners, published in a peer-reviewed journal and used to help refine an intervention model for an outdoor nature-based group intervention.This realist review will explore why mechanisms of social prescribing work, for what groups of people and their impact on enrolment, attendance and adherence to programmes. The use of realist approaches to detail the social prescribing process is novel and will offer insights into effective transfer of patients.PROSPERO CRD42016039491.

Abstract Background International policy has sought to emphasize and strengthen the link between the conservation of natural ecosystems and human development. Furthermore, international conservation organizations have broadened their objectives beyond nature-based goals to recognize the contribution of conservation interventions in sustaining ecosystem services upon which human populations are dependent. While many indices have been developed to measure various human well-being domains, the strength of evidence to support the effects, both positive and negative, of conservation interventions on human well-being, is still unclear. Methods/Design This protocol describes the methodology for examining the research question: What are the impacts of nature conservation interventions on different domains of human well-being in developing countries? Using systematic mapping, this study will scope and identify studies that measure the impacts of nature conservation interventions on human well-being at local to regional scales. The primary objective of this study is to synthesize the state and distribution of the existing evidence base linking conservation and human well-being. In addition, a theory of change approach will be used to identify and characterize the causal linkages between conservation and human well-being, with attention on those studies that examine the role of ecosystem services. Key trends among the resulting studies will be synthesized and the range of studies organized and presented in a graphical matrix illustrating the relationships between types of interventions and types of outcomes. Results of the study are intended to help conservation and development practitioners and the academic community to improve research studies and conservation practices in developing countries in order to achieve both conservation and human well-being outcomes.

Background We undertook a systematic review to evaluate the health benefits of environmental enhancement and conservation activities. We were concerned that a conventional process of study identification, focusing on exhaustive searches of bibliographic databases as the primary search method, would be ineffective, offering limited value. The focus of this study is comparing study identification methods. We compare (1) an approach led by searches of bibliographic databases with (2) an approach led by supplementary search methods. We retrospectively assessed the effectiveness and value of both approaches. Methods Effectiveness was determined by comparing (1) the total number of studies identified and screened and (2) the number of includable studies uniquely identified by each approach. Value was determined by comparing included study quality and by using qualitative sensitivity analysis to explore the contribution of studies to the synthesis. Results The bibliographic databases approach identified 21 409 studies to screen and 2 included qualitative studies were uniquely identified. Study quality was moderate, and contribution to the synthesis was minimal. The supplementary search approach identified 453 studies to screen and 9 included studies were uniquely identified. Four quantitative studies were poor quality but made a substantive contribution to the synthesis; 5 studies were qualitative: 3 studies were good quality, one was moderate quality, and 1 study was excluded from the synthesis due to poor quality. All 4 included qualitative studies made significant contributions to the synthesis. Conclusions This case study found value in aligning primary methods of study identification to maximise location of relevant evidence.

<h2>Abstract</h2><h3>Objectives</h3> This article provides reviewers with guidance on methods for identifying and processing evidence to understand intervention implementation. <h3>Study Design and Setting</h3> Strategies, tools, and methods are applied to the systematic review process to illustrate how process and implementation can be addressed using quantitative, qualitative, and other sources of evidence (i.e., descriptive textual and nonempirical). <h3>Results</h3> Reviewers can take steps to navigate the heterogeneity and level of uncertainty present in the concepts, measures, and methods used to assess implementation. Activities can be undertaken in advance of a Cochrane quantitative review to develop program theory and logic models that situate implementation in the causal chain. Four search strategies are offered to retrieve process and implementation evidence. Recommendations are made for addressing rigor or risk of bias in process evaluation or implementation evidence. Strategies are recommended for locating and extracting data from primary studies. The basic logic is presented to assist reviewers to make initial review-level judgments about implementation failure and theory failure. <h3>Conclusion</h3> Although strategies, tools, and methods can assist reviewers to address process and implementation using quantitative, qualitative, and other forms of evidence, few exemplar reviews exist. There is a need for further methodological development and trialing of proposed approaches.

ObjectiveTo identify examples of how social theories are used in systematic reviews of complex interventions to inform production of Cochrane guidance.Study Design and SettingSecondary analysis of published/unpublished examples of theories of social phenomena for use in reviews of complex interventions identified through scoping searches, engagement with key authors and methodologists supplemented by snowballing and reference searching. Theories were classified (low-level, mid-range, grand).ResultsOver 100 theories were identified with evidence of proliferation over the last 5 years. New low-level theories (tools, taxonomies, etc) have been developed for classifying and reporting complex interventions. Numerous mid-range theories are used; one example demonstrated how control theory had changed the review's findings. Review-specific logic models are increasingly used, but these can be challenging to develop. New low-level and mid-range psychological theories of behavior change are evolving. No reviews using grand theory (e.g., feminist theory) were identified. We produced a searchable Wiki, Mendeley Inventory, and Cochrane guidance.ConclusionsUse of low-level theory is common and evolving; incorporation of mid-range theory is still the exception rather than the norm. Methodological work is needed to evaluate the contribution of theory. Choice of theory reflects personal preference; application of theory is a skilled endeavor.

This systematic review and synthesis of qualitative research explored contextual factors relevant to non-pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) in schools.We conducted meta-ethnography to synthesise 34 studies, using theories of stigma to further develop the synthesis.Studies suggested that the classroom context requiring pupils to sit still, be quiet and concentrate could trigger symptoms of ADHD, and that symptoms could then be exacerbated through informal/formal labelling and stigma, damaged self-perceptions and resulting poor relationships with staff and pupils.Influences of the school context on symptoms of ADHD were often invisible to teachers and pupils, with most attributions made to the individual pupil and/or the pupil's family.We theorise that this 'invisibility' is at least partly an artefact of stigma, and that the potential for stigma for ADHD to seem 'natural and right' in the context of schools needs to be taken into account when planning any intervention.

Abstract Aims The aim of this study was to provide guidance to improve the completeness and clarity of meta‐ethnography reporting. Background Evidence‐based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta‐ethnography is a rigorous seven‐phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta‐ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta‐ethnography reporting guidance is needed to improve reporting quality. Design The eMERGe study used a rigorous mixed‐methods design and evidence‐based methods to develop the novel reporting guidance and explanatory notes. Methods The study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta‐ethnography conduct and reporting; (2) a review and audit of published meta‐ethnographies to identify good practice principles; (3) international, multidisciplinary consensus‐building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. Findings Recommendations and good practice for all seven phases of meta‐ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. Conclusion The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta‐ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta‐ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta‐ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho‐oncology, Review of Education, and BMC Medical Research Methodology .

Antimicrobial resistance (AMR) is a public health crisis that is predicted to cause 10 million deaths per year by 2050. The environment has been implicated as a reservoir of AMR and is suggested to play a role in the dissemination of antibiotic resistance genes (ARGs). Currently, most research has focused on measuring concentrations of antibiotics and characterising the abundance and diversity of ARGs and antibiotic resistant bacteria (ARB) in the environment. To date, there has been limited empirical research on whether humans are exposed to this, and whether exposure can lead to measureable impacts on human health. Therefore, the objective of this work is to produce two linked systematic maps to investigate previous research on exposure and transmission of AMR to humans from the environment. The first map will investigate the available research relating to exposure and transmission of ARB/ARGs from the environment to humans on a global scale and the second will investigate the prevalence of ARB/ARGs in various environments in the UK. These two maps will be useful for policy makers and research funders to identify where there are significant gluts and gaps in the current research, and where more primary and synthesis research needs to be undertaken.Separate search strategies will be developed for the two maps. Searches will be run in 13 databases, and grey literature will be sought from key websites and engagement with experts. Hits will be managed in EndNote and screened in two stages (title/abstract then full text) against predefined inclusion criteria. A minimum of 10% will be double screened with ongoing consistency checking. All included studies will have data extracted into a bespoke form designed and piloted for each map. Data to be extracted will include bibliographic details, study design, location, exposure source, exposure route, health outcome (Map 1); and prevalence/percentage of ARB/ARG (Map 2). No validity appraisal will be undertaken. Results will be tabulated and presented narratively, together with graphics showing the types and areas of research that has been undertaken and heatmaps for key exposure-health outcomes (Map 1) and exposure-prevalence (Map 2).

Abstract 1. To be effective, the next generation of conservation practitioners and managers need to be critical thinkers with a deep understanding of how to make evidence‐based decisions and of the value of evidence synthesis. 2. If, as educators, we do not make these priorities a core part of what we teach, we are failing to prepare our students to make an effective contribution to conservation practice. 3. To help overcome this problem we have created open access online teaching materials in multiple languages that are stored in Applied Ecology Resources. So far, 117 educators from 23 countries have acknowledged the importance of this and are already teaching or about to teach skills in appraising or using evidence in conservation decision‐making. This includes 145 undergraduate, postgraduate or professional development courses. 4. We call for wider teaching of the tools and skills that facilitate evidence‐based conservation and also suggest that providing online teaching materials in multiple languages could be beneficial for improving global understanding of other subject areas.

There is some evidence to suggest that animal-assisted interventions can have beneficial impact for residents in long-term care, but the focus of the evidence has largely been on behavioural and psychosocial measured outcomes. Animals, either as companion animals or in the form of pet/animal-assisted therapy, may provide benefits in the form of social contact, as well as opportunities for sensory experiences and meaningful engagement not picked up by outcome tools. This review aimed to create a state-of-knowledge synthesis, bringing together qualitative and quantitative findings, on the impact of animal-human interaction on care home residents and care home staff.Fourteen databases were searched from inception to July 2020. Forward and backward citation chasing of included articles was conducted. Screening was undertaken independently by a team of reviewers. Thematic synthesis and meta-analysis were used to synthesise the qualitative and quantitative data.Thirty-four studies, published in 40 articles (20 qualitative and 20 quantitative) were included. Five themes relating to resident wellbeing were identified in the qualitative evidence synthesis. These were animals as 'living beings', reminiscence and storytelling, caring (as 'doing' and 'feeling'), respite (from loneliness, institutionalisation, and illness), and sensory engagement. A sixth theme related to staff perceptions and wellbeing, and a seventh to animal health and wellbeing. Maintaining identity was identified as an overarching theme. The majority of randomised trials had small sample sizes and were rated as low quality, mostly showing no evidence of beneficial effect. There was, however, limited evidence of a positive effect of pet/animal interaction on outcomes of loneliness, anxiety and depression, supporting the themes of respite and sensory engagement.The presence of animals can significantly impact the health and wellbeing of some care home residents. Residents had meaningful relationships with animals and derived pleasure and comfort from them. Interacting with animals offered residents a way to maintain a sense of self in the care homes, and with support, residents with dementia could also express their identities. Facilitating residents to interact with animals as part of person-centred care may also help residents to feel 'at home' in the care home.PROSPERO registration no: CRD42017058201.

To review the use of case series in National Institute for Clinical Excellence (NICE) Health Technology Assessment (HTA) reports, to review systematically the methodological literature for papers relating to the validity of aspects of case series design, and to investigate characteristics and findings of case series using examples from the UK's Health Technology Assessment programme.Electronic databases. NICE website. Reports produced as part of the UK's HTA programme.NICE HTAs that used information from case series studies were obtained from the NICE website and a range of quality criteria applied. Searches of electronic databases, handsearched journals and the bibliographies of papers were made in order to find studies that assessed aspects of case series design, analysis or quality in relation to study validity. Hypotheses relating to the design of case series studies were developed and empirically investigated using four case examples from existing reports produced as part of the UK's HTA programme (functional endoscopic sinus surgery for nasal polyps, spinal cord stimulation for chronic back pain, percutaneous transluminal coronary angioplasty and coronary artery bypass grafting for chronic angina). Analysis was undertaken comparing studies within each review.There was no consensus on which case series to include in HTAs, how to use them or how to assess their quality, despite them being used in 30% of NICE HTAs. No previous studies empirically investigating methodological characteristics of case series were found. However, it is possible that the search strategy failed to find relevant studies. Poor reporting of case series characteristics severely constrained analysis and there were insufficient data to investigate all the hypotheses. Findings were not consistent across the different topics and were subject to considerable uncertainty. All the examples in our analysis were surgical interventions, which are prone to additional confounding factors due to difficulties of standardisation compared with drug treatment. Our findings may not be generalisable outside the interventions studied. The case series reports included generally exhibited poor reporting of methodological characteristics. This constrained our analysis. The use of several methods of analysis has led to apparently discrepant results. Given the number of analysis performed, the usual level of significance (p = 0.05) should be viewed with caution. The most important limitation of this study is the small number of cases on which the findings are based. The results are therefore tentative and should be viewed with caution.Case series are incorporated in a significant proportion of health technology assessments. Quality criteria have been used to appraise the quality of case series and decide on their inclusion in reviews of studies using this design. In this small series of case studies drawn from HTAs carried out for the NHS HTA programme, little evidence was found to support the use of many of the factors included in quality assessment tools. Importantly, no relationship was found between study size and outcome across the four examples studied. Isolated examples of a potentially important relationship between other methodological factors and outcome were shown, such as blinding of outcome measurement, but these were not shown consistently across the small number of examples studied. This study is based on a very small sample of studies and should therefore be considered as exploratory. Further investigation of the relationship between methodological features and outcome is justified given the frequency of use of case series in health technology assessments. Further research into the methodological features of case series and their outcome is justified in a wider sample of technologies and larger sets of case series. Value of information analyses including case series could be explored. Further exploration of the differences between case series and randomised controlled trial results, preferably using registry or comprehensive case series data, would be valuable.

Purpose There has been a considerable effort over the last decade to increase awareness of the tsunami risk in coastal Washington, USA. However, contemporary research on warning systems spawned by the recent Indian Ocean tsunami tragedy highlights the need for development of an effective tsunami warning system for both residents and transient populations, including visitors and tourists. This study sets out evaluate staff training for emergencies, emergency management exercises (including drills and evacuation), and hazard signage within motels and hotels in Ocean Shores, Washington, USA. Design/methodology/approach Data were collected from interviews with reception staff and managers at 18 hotels, motels, and other accommodation establishments. Findings Levels of staff training and preparedness for tsunami and other hazards were found to be generally very low, although examples of “best practice” were found at a select few establishments. Larger hotels already had orientation or general training programmes set up which had the potential to incorporate future tsunami and hazard training, while smaller “owner‐operator” businesses did not. Research limitations/implications Suggestions on how to improve preparedness are discussed, including undertaking training needs analyses and conducting workshops, simulations and employee training to empower both businesses and employees. Originality/value This case study provides an insight into the challenges faced by emergency managers and the tourism sector in improving the effectiveness of warning systems in areas with high transient populations.

Skin cancer is an increasing problem in Europe, America and Australasia, although largely preventable by avoiding excessive ultraviolet (UV) exposure. This paper presents the findings of a systematic review of qualitative research about the prevention of skin cancer attributable to UV exposure. The aim is to understand elements that may contribute to the successful or unsuccessful conveyance of skin cancer prevention messages and their uptake by the public. A systematic review was undertaken using evidence identified through searching electronic bibliographic databases and Web sites and reference list checks. Predefined inclusion and exclusion criteria were used. Sixteen study reports (relating to 15 separate studies) were included from the United Kingdom, United States, Australia, Canada and New Zealand. Each included study was quality appraised, and the findings were extracted into an evidence table. A coding scheme, framed by the Health Belief Model, was developed by the reviewers and informed analysis and synthesis. This showed that most people perceived their susceptibility to skin cancer, and its severity, as low. While benefits of adopting changed behaviour were acknowledged, there were substantial barriers to this, including positive perceptions of a tan as healthy and attractive and the hassle of covering up or using sunscreen. Peers, parents and media may offer ‘cues to action’ that encourage adoption of preventative behaviour and finally self-efficacy or the perceived ability to make such changes. Effective health education messages will need to address the barriers to adopting protective behaviours identified through this review.

This paper is a report of a systematic review and meta-ethnography of the experience of heavy menstrual bleeding.Heavy menstrual bleeding is common. Not all women seeking help have heavy menstrual bleeding as measured objectively and, conversely, some who do have this problem do not seek help.Seven electronic databases were searched in 2004 and updated in 2008, and supplemented with hand-searching.We identified four papers describing qualitative research among women with heavy menstrual bleeding. Key themes and concepts were extracted and synthesised using meta-ethnography, the key process of which is translation, identifying similar or contradictory findings in primary research. In the updated search three papers were identified.Three papers were largely descriptive. These provided support for the fourth paper's conceptual framework of a lay model of heavy menstrual bleeding which shows little overlap with the traditional clinical definition. Details of physical, practical and emotional elements of this model were identified. A matrix of uncertainties were identified suggesting reasons why women may or may not seek medical help for heavy menstrual bleeding. Women and healthcare professionals may conspire to privilege blood loss over other symptoms and the disease model of heavy menstrual bleeding is little help to either. Two papers from the updated search were also largely descriptive. The third interpreted key elements of the lay model as relating to the need for concealment demanded by 'menstrual etiquette'.A lay model of heavy menstrual bleeding is proposed, detailing key physical, social and emotional impacts that women find problematic.

This paper reports on a systematic review of qualitative research about vaginal practices in Sub-Saharan Africa, which used meta-ethnographic methods to understand their origins, their meanings for the women who use them, and how they have evolved in time and place. We included published documents which were based on qualitative methods of data collection and analysis and contained information on vaginal practices. After screening, 16 texts were included which dated from 1951 to 2008. We found that practices evolve and adapt to present circumstances and that they remain an important source of power for women to negotiate challenges that they face. Recent evidence suggests that some practices may increase a woman's susceptibility to HIV and other sexually transmitted infections. The success of new female-controlled prevention technologies, such as microbicides, might be determined by whether they can and will be used by women in the course of their daily life.

Nilotinib and dasatinib are now being considered as alternative treatments to imatinib as a first-line treatment of chronic myeloid leukaemia (CML).This technology assessment reviews the available evidence for the clinical effectiveness and cost-effectiveness of dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of Philadelphia chromosome-positive CML.Databases [including MEDLINE (Ovid), EMBASE, Current Controlled Trials, ClinicalTrials.gov, the US Food and Drug Administration website and the European Medicines Agency website] were searched from search end date of the last technology appraisal report on this topic in October 2002 to September 2011.A systematic review of clinical effectiveness and cost-effectiveness studies; a review of surrogate relationships with survival; a review and critique of manufacturer submissions; and a model-based economic analysis.Two clinical trials (dasatinib vs imatinib and nilotinib vs imatinib) were included in the effectiveness review. Survival was not significantly different for dasatinib or nilotinib compared with imatinib with the 24-month follow-up data available. The rates of complete cytogenetic response (CCyR) and major molecular response (MMR) were higher for patients receiving dasatinib than for those with imatinib for 12 months' follow-up (CCyR 83% vs 72%, p < 0.001; MMR 46% vs 28%, p < 0.0001). The rates of CCyR and MMR were higher for patients receiving nilotinib than for those receiving imatinib for 12 months' follow-up (CCyR 80% vs 65%, p < 0.001; MMR 44% vs 22%, p < 0.0001). An indirect comparison analysis showed no difference between dasatinib and nilotinib for CCyR or MMR rates for 12 months' follow-up (CCyR, odds ratio 1.09, 95% CI 0.61 to 1.92; MMR, odds ratio 1.28, 95% CI 0.77 to 2.16). There is observational association evidence from imatinib studies supporting the use of CCyR and MMR at 12 months as surrogates for overall all-cause survival and progression-free survival in patients with CML in chronic phase. In the cost-effectiveness modelling scenario, analyses were provided to reflect the extensive structural uncertainty and different approaches to estimating OS. First-line dasatinib is predicted to provide very poor value for money compared with first-line imatinib, with deterministic incremental cost-effectiveness ratios (ICERs) of between £256,000 and £450,000 per quality-adjusted life-year (QALY). Conversely, first-line nilotinib provided favourable ICERs at the willingness-to-pay threshold of £20,000-30,000 per QALY.Immaturity of empirical trial data relative to life expectancy, forcing either reliance on surrogate relationships or cumulative survival/treatment duration assumptions.From the two trials available, dasatinib and nilotinib have a statistically significant advantage compared with imatinib as measured by MMR or CCyR. Taking into account the treatment pathways for patients with CML, i.e. assuming the use of second-line nilotinib, first-line nilotinib appears to be more cost-effective than first-line imatinib. Dasatinib was not cost-effective if decision thresholds of £20,000 per QALY or £30,000 per QALY were used, compared with imatinib and nilotinib. Uncertainty in the cost-effectiveness analysis would be substantially reduced with better and more UK-specific data on the incidence and cost of stem cell transplantation in patients with chronic CML.The Health Technology Assessment Programme of the National Institute for Health Research.

Systematic reviews of qualitative evidence have been widely used to provide information on the context and implementation of interventions, and their potential barriers and facilitators. However, such reviews face a number of methodological challenges, and there are ongoing debates as to how qualitative evidence can best be used to inform our understanding of interventions. In this paper, we use a case study of two systematic reviews of qualitative evidence on the prevention of skin cancer to explore these issues. We find that qualitative evidence not directly related to interventions is likely to be of value for such reviews, that it is often not possible to construct fully comprehensive search strategies, and that there are diminishing returns to the synthesis, in terms of added value or insight, from the inclusion of large numbers of primary studies. We conclude that there are a number of ways in which systematic reviews of qualitative evidence can be utilised in conjunction with evidence on intervention effectiveness, without compromising the rigour of the review process. In particular, the use of theory to inform frameworks for synthesis is a promising way to integrate a broader range of qualitative evidence. Copyright © 2012 John Wiley & Sons, Ltd.

Numerous illnesses are associated with bathing in natural waters, although it is assumed that the risk of illness among bathers exposed to relatively clean waters found in high-income countries is negligible. A systematic review was carried out to quantify the increased risk of experiencing a range of adverse health outcomes among bathers exposed to coastal water compared with non-bathers.In all 6919 potentially relevant titles and abstracts were screened, and from these 40 studies were eligible for inclusion in the review. Odds ratios (OR) were extracted from 19 of these reports and combined in random-effect meta-analyses for the following adverse health outcomes: incident cases of any illness, ear infections, gastrointestinal illness and infections caused by specific microorganisms.There is an increased risk of experiencing symptoms of any illness [OR = 1.86, 95% confidence interval (CI): 1.31 to 2.64, P = 0.001] and ear ailments (OR = 2.05, 95% CI: 1.49 to 2.82, P < 0.001) in bathers compared with non-bathers. There is also an increased risk of experiencing gastrointestinal ailments (OR = 1.29, 95% CI: 1.12 to 1.49, P < 0.001).This is the first systematic review to evaluate evidence on the increased risk of acquiring illnesses from bathing in seawater compared with non-bathers. Our results support the notion that infections are acquired from bathing in coastal waters, and that bathers have a greater risk of experiencing a variety of illnesses compared with non-bathers.

Reducing unnecessary prescribing remains a key priority for tackling the global rise of antibiotic-resistant infections.The authors sought to update a 2011 qualitative synthesis of GPs' experiences of antibiotic prescribing for acute respiratory tract infections (ARTIs), including their views of interventions aimed at more prudent prescribing. They expanded the original scope to encompass all primary care professionals (PCPs) who can prescribe or dispense antibiotics for ARTIs (for example, nurses and pharmacists).Systematic review and meta-ethnography of qualitative studies.A systematic search was conducted on MEDLINE, EMBASE, PsycINFO, CINAHL, ASSIA, and Web of Science. No date or language restrictions were used. Identified studies were grouped according to their thematic focus (usual care versus intervention), and two separate syntheses were performed.In all, 53 articles reporting the experiences of >1200 PCPs were included. Analysis of usual-care studies showed that PCPs tend to assume multiple roles in the context of ARTI consultations (the expert self, the benevolent self, the practical self), depending on the range of intrapersonal, interpersonal, and contextual situations in which they find themselves. Analysis of intervention studies identified four possible ways in which PCPs may experience quality improvement interventions (compromise, 'supportive aids', source of distress, and unnecessary).Contrary to the original review, these results suggest that the use of the same intervention is experienced in a totally different way by different PCPs, and that the same elements that are perceived as benefits by some could be viewed as drawbacks by others. Acceptability of interventions is likely to increase if these are context sensitive and take into account PCPs' varying roles and changing priorities.

Action taken to enhance or conserve outdoor environments may benefit health and wellbeing through the process of participation but also through improving the environment. There is interest, amongst both health and environmental organisations, in using such activities as health promotion interventions. The objective of this systematic review was to investigate the health and wellbeing impacts of participation in environmental enhancement and conservation activities and to understand how these activities may be beneficial, to whom and in what circumstances or contexts. A theory-led mixed-method systematic review was used to assess evidence of effect and to identify pathways to change (protocol: http://onlinelibrary.wiley.com/doi/ 10.1002/14651858.CD010351/full ). Due to the multi-disciplinary, dispersed and disparate body of evidence an extensive multi-stage search strategy was devised and undertaken. Twenty-seven databases and multiple sources of grey literature were searched and over 200 relevant organisations were contacted. The heterogenous evidence was synthesised using a narrative approach and a conceptual model was developed to illustrate the mechanisms of effect. Due to the limited nature of the evidence additional higher order evidence was sought to assess the plausibility of the proposed mechanisms of effect through which health and wellbeing may accrue. The majority of the quantitative evidence (13 studies; all poor quality and lower-order study designs) was inconclusive, though a small number of positive and negative associations were observed. The qualitative evidence (13 studies; 10 poor quality, 3 good) indicated that the activities were perceived to have value to health and wellbeing through a number of key mechanisms; including exposure to natural environments, achievement, enjoyment and social contact. Additional high level evidence indicated that these pathways were plausible. Despite interest in the use of environmental enhancement activities as a health intervention there is currently little direct evidence of effect, this is primarily due to a lack of robust study designs. Further rigorous research is needed to understand the potential of the activities to benefit health and environment.

Abstract Background Forests provide an essential resource that support the livelihoods of an estimated 20% of the global population. Forests are thought to serve in three primary roles to support livelihoods: subsistence, safety nets, and pathways to prosperity. While we have a working understanding of how poor people depend on forests in individual sites and countries, much of this evidence is dispersed and not easily accessible. Thus, while the importance of forest ecosystems and resources to contribute to poverty alleviation has been increasingly emphasized in international policies, conservation and development initiatives and investments—the strength of evidence to support how forests can affect poverty outcomes is still unclear. This study takes a systematic mapping approach to scope, identify and describe studies that measure the effect of forest-based activities on poverty outcomes at local and regional scales. This effort builds upon an existing systematic map on linkages between conservation and human well-being in order to make this process more efficient. We will conduct a refined and updated search strategy pertinent to forests-poverty linkages to glean additional evidence from studies outside the scope of the original map. Results of this study can be used for informing conservation and development policy and practices in global forest ecosystems and highlight evidence gaps where future primary studies and systematic reviews can add value. Methods We build upon the search strategy outlined in McKinnon et al. (Environ Evid 1–25, 2016) and expand our search to cover a total of 7 bibliographic databases, 15 organizational websites, 8 existing systematic reviews and maps, and evidence gap maps, and solicit key informants. All searches will be conducted in English and encompass all nations. Search results will be screened at title, abstract, and full text levels, recording both the number of excluded articles and reasons for exclusion. Full text assessment will be conducted on all included article and extracted data will be reported in a narrative review that will summarize trends in the evidence, report any knowledge gaps and gluts, and provide insight for policy, practice and future research. The data from this systematic map will be made available as well, through an open access, searchable data portal and visualization tool.

Having contact with nature can be beneficial for health and wellbeing, but many older adults face barriers with getting outdoors. We conducted a systematic review of quantitative studies on health and wellbeing impacts of indoor forms of nature (both real and simulated/artificial), for older adults in residential settings.Search terms relating to older adults and indoor nature were run in 13 scientific databases (MEDLINE, CINAHL, AgeLine, Environment Complete, AMED, PsychINFO, EMBASE, HMIC, PsychARTICLES, Global Health, Web of Knowledge, Dissertations and Theses Global, and ASSIA). We also pursued grey literature, global clinical trials registries, and a range of supplementary methods.Of 6,131 articles screened against eligibility criteria, 26 studies were accepted into the review, and were quality-appraised using the Effective Public Health Practice Project (EPHPP) tool. The participants were 930 adults aged over 60. Nature interventions and health/wellbeing outcomes were heterogeneous, which necessitated a narrative synthesis. The evidence base was generally weak, with 18 of 26 studies having a high risk of bias. However, several higher-quality studies found indoor gardening and horticulture programs were effective for cognition, psychological wellbeing, social outcomes, and life satisfaction.There is inconsistent evidence that indoor nature exposures are beneficial for older care residents. We expect that successful interventions were, at least partly, facilitating social interaction, supporting feelings of autonomy/control, and promoting skill development, that is, factors not necessarily associated with nature per se. Higher-quality studies with improved reporting standards are needed to further elucidate these mechanisms.

Approaches to synthesizing qualitative data have, to date, largely focused on integrating the findings from published reports. However, developments in text mining software offer the potential for efficient analysis of large pooled primary qualitative datasets. This case study aimed to (a) provide a step‐by‐step guide to using one software application, Leximancer, and (b) interrogate opportunities and limitations of the software for qualitative data synthesis. We applied Leximancer v4.5 to a pool of five qualitative, UK‐based studies on transportation such as walking, cycling, and driving, and displayed the findings of the automated content analysis as intertopic distance maps. Leximancer enabled us to “zoom out” to familiarize ourselves with, and gain a broad perspective of, the pooled data. It indicated which studies clustered around dominant topics such as “people.” The software also enabled us to “zoom in” to narrow the perspective to specific subgroups and lines of enquiry. For example, “people” featured in men's and women's narratives but were talked about differently, with men mentioning “kids” and “old,” whereas women mentioned “things” and “stuff.” The approach provided us with a fresh lens for the initial inductive step in the analysis process and could guide further exploration. The limitations of using Leximancer were the substantial data preparation time involved and the contextual knowledge required from the researcher to turn lines of inquiry into meaningful insights. In summary, Leximancer is a useful tool for contributing to qualitative data synthesis, facilitating comprehensive and transparent data coding but can only inform, not replace, researcher‐led interpretive work.

Qualitative research related to the human dimensions of conservation and environment is growing in quantity. Rigorous syntheses of such studies can help develop understanding and inform decision-making. They can combine findings from studies in varied or similar contexts to address questions relating to, for example, the lived experience of those affected by environmental phenomena or interventions, or to intervention implementation. Researchers in environmental management have adapted methodology for systematic reviews of quantitative research so as to address questions about the magnitude of intervention effects or the impacts of human activities or exposure. However, guidance for the synthesis of qualitative evidence in this field does not yet exist. The objective of this paper is to present a brief overview of different methods for the synthesis of qualitative research and to explore why and how reviewers might select between these. The paper discusses synthesis methods developed in other fields but applicable to environmental management and policy. These methods include thematic synthesis, framework synthesis, realist synthesis, critical interpretive synthesis and meta-ethnography. We briefly describe each of these approaches, give recommendations for the selection between them, and provide a selection of sources for further reading.

For more than 4 5 billion people, approximately 15% of their daily per capita intake of animal protein comes from marine products 5 Seafood provides a source of micronutrients and omega-3 fatty acids essential for good physical and mental health Studies over the past 10 years have demonstrated that spending time in highquality blue spaces (through leisure activities or living in a coastal environment) directly supports and enhances health and well-being, combatting obesity and mental health problems, particularly in deprived populations 6 This highlights an enormous potential for these well-being promotion initiatives and healthcare interventions to address both preexisting and emerging health issues beyond the lifetime of the pandemic There is now a tremendous opportunity and public momentum for health professionals to join with ocean researchers to help policymakers, the business community, and the wider public to address systemic global challenges in a new way (http://bit ly/2ZDFMS3) 7 We need international alliances, transdisciplinary collaborations, and global governance that support innovative, systemic ways of managing ocean resources ACKNOWLEDGMENTS The research was supported in part by the European Union's Horizon 2020 research and innovation programme (grants 774567 [H2020 SOPHIE Project] and 666773 [H2020 BlueHealth Project]);the UK Natural Environment Research Council and the UK Research and Innovation's Global Challenges Research Fund for the Blue Communities Project;the Blue Climate Initiative Health and Wellbeing Subgroup (https://www blueclimateinitiative org);the University of Girona;the City Council of Roses;the Catalan Fishmonger's Association;the Roses Fishers' Association;the Town Council of Tossa de Mar;and the government of Catalonia (the sponsors of the Roses Oceans and Human Health Chair)

Abstract Introduction We conducted a systematic review of qualitative evidence to improve understanding of the processes and outcomes of redress and reconciliation following a life‐changing event from the perspectives of individuals experiencing the event and their families. Methods We searched six bibliographic databases for primary qualitative evidence exploring the views of individuals who have experienced a life‐changing event, and/or their family or carers, of redress or reconciliation processes. This was supplemented with targeted database searches, forward and backward citation chasing and searches of Google Scholar and relevant websites. Title and abstract and full‐text screening were undertaken independently by two reviewers. Data extraction and quality appraisal were conducted by one reviewer and checked by a second. We used a best‐fit framework synthesis approach, drawing upon procedural and restorative justice concepts. Findings Fifty‐three studies (61 papers) were eligible for inclusion. Forty‐one studies (47 papers) were included in the synthesis, from which we identified four themes. Three themes ‘Transparency’, ‘Person‐centered’ and ‘Trustworthy’ represent the procedural elements required to support a fair and objective process. The fourth, ‘Restorative justice’ encapsulates how a fair process feels to those who have experienced a life‐changing event. This theme highlights the importance of an empathic relationship between the different parties involved in the redress‐reconciliation process and the significance of being able to engage in meaningful action. Conclusion Our findings highlight the procedural aspects and context of redress‐reconciliation processes required to ensure that the process and outcomes are experienced as fair. These criteria may be applied to the processes used to investigate both recent and historical patient safety events. Public Contribution One member of the public affiliated with the Exeter Policy Research Programme Evidence Review Facility helped develop the review protocol. Two people with experience of medically life‐changing events provided insight which corroborated our findings and identified important limitations of the evidence included in this review.

To establish the effectiveness and cost-effectiveness of cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) for people on dialysis due to end-stage renal disease (ESRD).Electronic databases were searched up to February 2006.Included randomised controlled trials (RCTs) on the clinical effectiveness of cinacalcet for SHPT in ESRD were critically appraised, had relevant data extracted and were summarised narratively. A Markov (state transition) model was developed that compared cinacalcet in addition to current standard treatment with phosphate binders and vitamin D to standard treatment alone. A simulated cohort of 1000 people aged 55 with SHPT was modelled until the whole cohort was dead. Incremental costs and quality-adjusted life-years (QALYs) were calculated. Extensive one-way sensitivity analysis was undertaken as well as probabilistic sensitivity analysis.Seven trials comparing cinacalcet plus standard treatment with placebo plus standard treatment were included in the systematic review. A total of 846 people were randomised to receive cinacalcet. Cinacalcet was more effective at meeting parathyroid hormone (PTH) target levels (40% vs 5% in placebo, p < 0.001). In those patients meeting PTH targets, 90% also experienced a reduction in calcium-phosphate product levels, compared with 1% in placebo. Significantly fewer people treated with cinacalcet were hospitalised for cardiovascular events, although no difference was seen in all-cause hospitalisation or mortality. Significantly fewer fractures and parathyroidectomies were also seen with cinacalcet. Findings on all patient-based clinical outcomes were based on small numbers. The authors' economic model estimated that, compared to standard treatment alone, cinacalcet in addition to standard care costs an additional 21,167 pounds and confers 0.34 QALYs (or 18 quality-adjusted weeks) per person. The incremental cost-effectiveness ratio (ICER) was 61,890 pounds/QALY. In most cases, even extreme adjustments to individual parameters did not result in an ICER below a willingness-to-pay threshold of 30,000 pounds/QALY with probabilistic analysis showing only 0.5% of simulations to be cost-effective at this threshold. Altering the assumptions in the model through using different data sources for the inputs produced a range of ICERs from 39,000 pounds to 92,000 pounds/QALY.Cinacalcet in addition to standard care is more effective than placebo plus standard care at reducing PTH levels without compromising calcium levels. However, there is limited information about the impact of this reduction on patient-relevant clinical outcomes. Given the short follow-up in the trials, it is unclear how data should be extrapolated to the long term. Together with the high drug cost, this leads to cinacalcet being unlikely to be considered cost-effective. Recommendations for future research include obtaining accurate estimates of the multivariate relationship between biochemical disruption in SHPT and long-term clinical outcomes.

To review and synthesise qualitative research studies that have explored patients' experience of deep brain stimulation (DBS) in advanced Parkinson's disease (PD).Systematic review and meta-synthesis of 7 original papers, using metaethnography.Studies conducted in Denmark, France and Sweden.116 patients who had undergone DBS and 9 spouses of patients.Prior to surgery, the experience of advancing PD is one of considerable loss and a feeling of loss of control. There are significant hopes for what DBS can bring. Following surgery, a sense of euphoria is described by many, although this does not persist and there is a need for significant transitions following this. We suggest that normality as a concept is core to the experience of DBS and that a sense of control may be a key condition for normality. Experience of DBS for patients and spouses, and of the transitions that they must undertake, is influenced by their hopes of what surgery will enable them to achieve, or regain (ie, a new normality).There is a need for further qualitative research to understand the nature of these transitions to inform how best patients and their spouses can be supported by healthcare professionals before, during and after DBS. In assessing the outcomes of DBS and other treatments in advanced PD, we should consider how to capture holistic concepts such as normality and control. Studies that examine the outcomes of DBS require longer term follow-up.

To identify the metrics or methods used by researchers to determine the effectiveness of literature searching where supplementary search methods are compared to bibliographic database searching. We also aimed to determine which metrics or methods are summative or formative and how researchers defined effectiveness in their studies.Systematic review. We searched MEDLINE and Embase to identify published studies evaluating literature search effectiveness in health or allied topics.Fifty studies met full-text inclusion criteria. Six metrics (sensitivity, specificity, precision, accuracy, number needed to read, and yield) and one method (capture recapture) were identified.Studies evaluating effectiveness need to identify clearly the threshold at which they will define effectiveness and how the evaluation they report relates to this threshold. Studies that attempt to investigate literature search effectiveness should be informed by the reporting of confidence intervals, which aids interpretation of uncertainty around the result, and the search methods used to derive effectiveness estimates should be clearly reported and validated in studies.

Globally, there is increasing scientific evidence of critical links between the oceans and human health, with research into issues such as pollution, harmful algal blooms and nutritional contributions. However, Oceans and Human Health (OHH) remains an emerging discipline. As such these links are poorly recognized in policy efforts such as the Sustainable Development Goals, with OHH not included in either marine (SDG14) or health (SDG3) goals. This is arguably short-sighted given recent development strategies such as the EU Blue Growth Agenda. In this systematic map we aim to build on recent efforts to enhance OHH in Europe by setting a baseline of existing evidence, asking: What links have been researched between marine environments and the positive and negative impacts to human health and wellbeing? We searched eight bibliographic databases and queried 57 organizations identified through stakeholder consultation. Results include primary research and systematic reviews which were screened double blind against pre-defined inclusion criteria as per a published protocol. Studies were limited to Europe, US, Australia, New Zealand and Canada. Data was extracted according to a stakeholder-defined code book. A narrative synthesis explores the current evidence for relationships between marine exposures and human health outcomes, trends in knowledge gaps and change over time in the OHH research landscape. The resulting database is available on the website of the Seas, Oceans and Public Health in Europe website (https://sophie2020.eu/). A total of 1,542 unique articles were included in the database, including those examined within 56 systematic reviews. Research was dominated by a US focus representing 50.1% of articles. A high number of articles were found to link: marine biotechnology and cardiovascular or immune conditions, consumption of seafood and cardiovascular health, chemical pollution and neurological conditions, microbial pollution and gastrointestinal or respiratory health, and oil industry occupations with mental health. A lack of evidence relates to direct impacts of plastic pollution and work within a number of industries identified as relevant by stakeholders. Research over time is dominated by marine biotechnology, though this is narrow in focus. Pollution, food and disease/injury research follow similar trajectories. Wellbeing and climate change have emerged more recently as key topics but lag behind other categories in volume of evidence. The evidence base for OHH of relevance to European policy is growing but remains patchy and poorly co-ordinated. Considerable scope for future evidence synthesis exists to better inform policy-makers, though reviews need to better incorporate complex exposures. Priorities for future research include: proactive assessments of chemical pollutants, measurable impacts arising from climate change, effects of emerging marine industries, and regional and global assessments for OHH interactions. Understanding of synergistic effects across multiple exposures and outcomes using systems approaches is recommended to guide policies within the Blue Growth Strategy. Co-ordination of research across Europe and dedicated centres of research would be effective first steps.

Conservation activities and natural resource management interventions have often aimed to tackle the dual challenge of improving nature conservation and human well-being. However, there is concern over the extent to which this dual goal has been achieved, and an increasing recognition of trade-offs and synergies within and between aspects of each of the goals. The amount and scope of the available evidence on the success of conservation and management interventions in both arenas has lacked documentation, for a number of reasons, including limited resources for monitoring and evaluation and the difficulty in bringing together a disparate evidence base. This systematic map focuses on the interaction between marine conservation management and the health and well-being of coastal communities in South East Asia. We searched bibliographic databases to find published literature, and identified grey literature through institutional and organisational website searches and key stakeholders. Eligibility criteria were applied in two stages, title and abstract and full text, with consistency checks. We extracted meta-data on the design and characteristics of each study, from which we produced an interactive database and map, and a narrative summary. We assessed 42,894 records at title and abstract from the main searches. 1,331 articles were assessed at full text (30 articles were not retrievable). 287 articles (281 studies) were included in the systematic map. Most studies were peer-reviewed publications (90%), and from the Philippines and Indonesia (72%). 31% of studies were solely qualitative, 45% were solely quantitative and 24% included both qualitative and quantitative research. Only 24% (31/127) of quantitative studies included a comparator. We identified knowledge clusters where studies investigated the links between the marine conservation interventions: Site Protection, Economic or Livelihood Incentives or Alternatives, or Habitat Management, and the human health and well-being outcomes: Economic Living Standards, Governance and Empowerment, or Social Relations. In addition, qualitative research clusters were identified exploring the links between the intervention Habitat Management, and the outcome Governance and Empowerment, and between the intervention Economic or Livelihood Incentives or Alternatives, and the outcomes of Governance and Empowerment, and Social Relations. We identified major knowledge gaps in evidence for the effect of marine conservation interventions on the outcomes Freedom of Choice and Action, Security and Safety, Subjective Well-being, Health, and Culture and Spirituality. There was a lack of studies involving Education, Awareness and Activism interventions that reported any human health and well-being outcomes. We present the first updatable, interrogable and comprehensive evidence map on this topic for South East Asia. Our work supports further, detailed investigation of knowledge clusters using systematic review and also serves to identify understudied topic areas. The lack of comparative, quantitative studies suggests that future research should include counterfactuals to strengthen the robustness of evidence base. Users of this systematic map should recognise that much evidence may be national or locally specific, and that we did not undertake an assessment of study quality. Thus, when considering implications for policy and decision-making, users should carefully consider the heterogeneity of available evidence and refer to original research articles to gain a full depth of understanding and context.

To estimate the clinical effectiveness and cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA) for heavy menstrual bleeding (HMB), compared with the existing (first-generation) endometrial ablation (EA) techniques of transcervical resection (TCRE) and rollerball (RB) ablation, and hysterectomy.Electronic databases, bibliographies of articles, and also experts in the field and relevant industry bodies were asked to provide information.A detailed search strategy was carried out to identify systematic reviews and controlled trials of MEA and TBEA versus first-generation techniques for EA. In addition to electronic database searching, reference lists were hand-searched and information sought from manufacturers of EA devices and by experts in the field. A deterministic Markov model was developed to assess cost-effectiveness. Data for the model were taken from a range of sources.The systematic review of first-generation EA techniques versus hysterectomy found that EA offered an alternative to hysterectomy for HMB, with fewer complications and a shorter recovery period. Satisfaction and effectiveness were high for both MEA and TBEA. Costs were lower with EA although the difference narrows over time. Second-generation EA techniques are an alternative treatment to first-generation techniques for HMB, and first-generation techniques are known to offer an alternative to hysterectomy. Although no trials of second-generation techniques and hysterectomy have been undertaken, it seems reasonable to assume that second-generation techniques also offer an alternative surgical treatment. Using the model to assess cost-effectiveness, costs were very slightly higher for MEA when compared to TBEA, and differences in quality-adjusted life-years (QALYs) were negligible. For MEA compared with transcervical resection of the endometrium (TCRE) and RB ablation, costs were slightly lower with MEA and MEA accrued very slightly more QALYs. Compared with hysterectomy, MEA costs less and accrues slightly fewer QALYs. For TBEA compared with TCRE and RB ablation, costs were lower with TBEA and TBEA accrued slightly more QALYs. Compared with hysterectomy, TBEA costs moderately less and accrues moderately fewer QALYs.Overall, there were few significant differences between the outcomes of first- and second-generation techniques including bleeding, satisfaction and QoL measures and repeat surgery rates. Second-generation techniques had significantly shorter operating and theatre times and there appear to be fewer serious perioperative adverse effects with second-generation techniques and postoperative effects are similar. Compared with hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalisation and faster return to work. Hysterectomy results in more adverse effects and is more expensive, although the need for retreatment leads this difference to decrease over time. Satisfaction with hysterectomy is initially higher, but there is no significant difference after 2 years. The economic model suggests that second-generation techniques are more cost-effective than first-generation techniques of EA for HMB. Both TBEA and MEA appear to be less costly than hysterectomy, although the latter results in more QALYs. Further research is suggested to make direct comparisons of the cost-effectiveness of second-generation EA techniques, to carry out longer term follow-up for all methods of EA in RCTs, and to develop more sophisticated modelling studies. Further research is also recommended into HMB to establish health-state utility values, its surgical treatment, convalescence, complications of treatment, symptoms and patient satisfaction.

Objective To assess the cost effectiveness of the second‐generation surgical treatments for heavy menstrual bleeding (microwave and thermal balloon endometrial ablation) compared with existing endometrial ablation techniques (transcervical resection and rollerball, alone or in combination) and hysterectomy. Design A state transition (Markov) cost–utility economic model. Population Women with heavy menstrual bleeding. Methods A Markov model was developed using spreadsheet software. Transition probabilities, costs and quality of life data were obtained from a systematic review of effectiveness undertaken by the authors, from published sources, and expert opinion. Cost data were obtained from the literature and from a NHS trust hospital. Indirect comparison of thermal balloon endometrial ablation versus microwave endometrial ablation or either second‐generation endometrial ablation method versus hysterectomy, and comparison of second‐generation versus first‐generation techniques were carried out from the perspective of health service payers. The effects of uncertainty were explored through extensive one‐way sensitivity analyses and Monte Carlo simulation. Main outcome measures Incremental cost effectiveness ratios based on cost per quality adjusted life year (QALY) gained, and cost effectiveness acceptability curves. Results Compared with first‐generation techniques, both microwave and thermal balloon endometrial ablation cost less and accrued more QALYs. Hysterectomy was more expensive, but accrued more QALYs than all endometrial ablation methods. Baseline results showed that differences between microwave endometrial ablation and thermal balloon endometrial ablation were slight. Sensitivity analyses showed that small changes in values may have a marked effect on cost effectiveness. Probabilistic simulation highlighted the uncertainty in comparisons between different endometrial ablation options, particularly between second‐generation techniques. Conclusions Despite limitations in available data, the analysis suggests that second‐generation techniques are likely to be more cost effective than first‐generation techniques in most cases. Hysterectomy, where a woman finds this option acceptable, continues to be a very cost effective procedure compared with all endometrial ablation methods.

While confidentiality is recognised as a key aspect of successful health services aimed at young people, most research has looked at the concerns of those in urban centres. This paper reports on qualitative and quantitative data collected from general practitioners (GPs) and young people in a rural health district.To assess the concerns of rural teenagers regarding anonymity and confidentiality when accessing sexual health services.The views of teenagers about using health services for issues of sexual health were sought through an in-school survey of 311 Year 9 and 119 Year 11 students. In addition, 18 single-sex focus groups discussions were conducted in North and East Devon. All GPs in the district were asked to complete a questionnaire.These reveal that the particular concerns of young people from small communities are more to do with the difficulties of remaining anonymous, which are related to visibility and lack of privacy in small communities. These problems were more pervasive among rural young people than those concerns more usually reported about confidential consultations.

Conventional treatments for atopic eczema include topical corticosteroids (TCS) and emollients. Pimecrolimus, an immunosuppressant, was licensed in the U.K. in 2003 as an alternative treatment of mild to moderate atopic eczema.To assess the cost-utility of pimecrolimus as a treatment for mild and moderate atopic eczema when compared with conventional treatments which use TCS and emollients.A Markov state-transition model was developed to represent the cyclical nature of atopic eczema and provide an economic analysis of cost-utility for treatment alternatives from the perspective of a third party payer (U.K. National Health Service). A range of methods was used to obtain data for transition probabilities, costs and quality of life. These included a systematic review of published effectiveness data, expert opinion, and a utility study conducted by the authors. Separate cohort analyses were modelled to distinguish between children and adult populations and between differing treatment patterns for facial and body eczema. One-way sensitivity analyses and probabilistic sensitivity analysis (using Monte-Carlo simulation) were performed.Baseline cost-utility outputs from the model show that, in all tested scenarios, TCS dominate pimecrolimus (i.e. TCS are both cheaper and more effective). However, the differences in benefits between treatments output by the model are very small. Sensitivity analyses highlight the importance of cost variations in pimecrolimus. Where pimecrolimus is compared with emollient only it is probably cost effective at a willingness-to-pay threshold of 30 000 UK pounds per quality-adjusted life year.There are likely to be few situations in which the use of pimecrolimus for the treatment of atopic eczema can be justified on economic grounds. Exceptions are likely to be in cases where TCS have been shown to be ineffective, unacceptable due to adverse events, or where a patient is unwilling to accept TCS treatment despite appropriate education and support and emollient alone is the alternative clinical option.

Secondary hyperparathyroidism (SHPT) is a common side effect of end-stage renal disease (ESRD) and is associated with increased risk of fracture and cardiovascular events (CV). Current standard treatment includes dietary control, phosphate binders and vitamin D. However, many patients do not have their parathyroid hormone (PTH), calcium and phosphate levels controlled by this regimen. Cinacalcet is the first of a new class of calcimimetic drugs which suppress PTH production. Although there is convincing evidence of the impact of cinacalcet on serum biomarkers, the long-term clinical implications of treatment are less clear. The aim of this study is to estimate the cost-utility of cinacalcet as an addition to standard treatment of SHPT compared with standard treatment alone.A Markov model was developed to estimate the incremental cost-utility of cinacalcet. Uncertainty was explored through extensive sensitivity analysis.Compared with standard treatment, cinacalcet incurs average additional lifetime costs of pound21,167 per person and confers an additional 0.34 quality adjusted life years, resulting in an incremental cost-effectiveness ratio of pound61,890 (approximately euro89,000) per quality-adjusted life-year (QALY). Extensive one-way sensitivity analysis showed that cinacalcet was only likely to be considered cost-effective if the relative risk of mortality for people with very high levels of PTH was 2.2 compared with people whose PTH reached target levels, or if drug costs were considerably reduced. Probabilistic sensitivity analysis showed cinacalcet was very unlikely to be cost-effective at usual levels of willingness to pay in the National Health Service (NHS).Unless the cost of cinacalcet is considerably reduced, it is unlikely to be considered a cost-effective treatment for people with SHPT.