Megan Wainwright

Applying GRADE-CERQual to qualitative evidence synthesis findings: introduction to the series

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.

Applying GRADE-CERQual to qualitative evidence synthesis findings—paper 2: how to make an overall CERQual assessment of confidence and create a Summary of Qualitative Findings table

BackgroundThe 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.MethodsWe 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.ResultsConfidence 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.ConclusionsStructuring 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.

Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 6: how to assess relevance of the data

BackgroundThe 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.MethodsWe 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.ResultsWhen 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.ConclusionsThis 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.

Self-management of medical abortion : a qualitative evidence synthesis.

Abstract Medical abortion is a method of pregnancy termination that by its nature enables more active involvement of women in the process of managing, and sometimes even administering the medications for, their abortions. This qualitative evidence synthesis reviewed the global evidence on experiences with, preferences for, and concerns about greater self-management of medical abortion with lesser health professional involvement. We focused on qualitative research from multiple perspectives on women’s experiences of self-management of first trimester medical abortion (< 12 weeks gestation). We included research from both legal and legally-restricted contexts whether medical abortion was accessed through formal or informal systems. A review team of four identified 36 studies meeting inclusion criteria, extracted data from these studies, and synthesized review findings. Review findings were organized under the following themes: general perceptions of self-management, preparation for self-management, logistical considerations, issues of choice and control, and meaning and experience. The synthesis highlights that the qualitative evidence base is still small, but that the available evidence points to the overall acceptability of self-administration of medical abortion. We highlight particular considerations when offering self-management options, and identify key areas for future research. Further qualitative research is needed to strengthen this important evidence base. Résume L’avortement médicamenteux est une méthode d’interruption de grossesse qui, par sa nature, permet une participation plus active des femmes à la gestion, et parfois même l’administration des médicaments pour leur propre avortement. Cette synthèse de données qualitatives a examiné les données mondiales sur les expériences, les préférences et les préoccupations relatives à une autogestion croissante de l’avortement médicamenteux, avec une moindre participation des professionnels de santé. Nous nous sommes concentrés sur la recherche qualitative, depuis de multiples perspectives, sur la manière dont les femmes ont vécu l’autogestion d’un avortement médicamenteux du premier trimestre (< 12 semaines) de gestation. Nous avons inclus la recherche portant sur des environnements légaux et juridiquement restrictifs, que l’avortement médicamenteux ait été obtenu par des systèmes formels ou informels. Une équipe de quatre personnes a sélectionné 36 études réunissant les critères d’inclusion, en a extrait des données et rédigé un projet de synthèse. Les résultats ont été organisés d’après les thèmes suivants : perceptions générales de l’autogestion, préparation à l’autogestion, considérations logistiques, questions de choix et contrôle, et signification et expérience. La synthèse montre que la base de données qualitative est encore mince, mais que ces informations indiquent une acceptabilité globale de l’auto-administration. Nous soulignons des points particuliers à prendre en compte lors de l’application des options d’autogestion, et nous identifions des domaines clés pour de futures recherches. Il faut poursuivre les recherches qualitatives pour étoffer cette base de données importante. Resumen El aborto con medicamentos es un método de interrupción del embarazo que por su naturaleza permite una participación más activa de las mujeres en el proceso de manejar, y en algunos casos incluso administrar los medicamentos, para su aborto. Esta síntesis de evidencia cualitativa revisó la evidencia mundial de experiencias, preferencias e inquietudes relacionadas con mayor automanejo del aborto con medicamentos y menos participación de profesionales de la salud. Nos enfocamos en investigaciones cualitativas, desde múltiples puntos de vista sobre las experiencias de las mujeres con el automanejo del aborto con medicamentos en el primer trimestre de embarazos (< 12 semanas) de gestación. Incluimos investigaciones de contextos donde es legal y donde es restringido por la ley, ya sea que los servicios de aborto con medicamentos hayan sido accedidos por medio de sistemas formales o informales. Un equipo de revisión integrado por cuatro personas identificó 36 estudios que reunían los criterios de inclusión, extrajó datos de estos estudios y redactó los hallazgos de la revisión sintetizada. Los hallazgos fueron organizados bajo las siguientes temáticas: percepciones generales del automanejo, preparación para el automanejo, consideraciones logísticas, asuntos de elección y control, y significado y experiencia. La síntesis destaca que la base de evidencia cualitativa aún es pequeña, pero que la evidencia existente indica la aceptación general de la autoadministración. Destacamos asuntos específicos que deben ser considerados al aplicar las opciones de automanejo, e identificamos áreas clave para futuras investigaciones. Se necesitan más investigaciones cualitativas para fortalecer esta importante base de evidencia.

Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 4: how to assess coherence

BackgroundThe 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.MethodsWe 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.ResultsWhen 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.ConclusionsThis 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.

Applying GRADE-CERQual to qualitative evidence synthesis findings — paper 5: how to assess adequacy of data.

BackgroundThe 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.MethodsWe 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.ResultsWhen 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.ConclusionsThis 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.

Applying GRADE-CERQual to qualitative evidence synthesis findings—paper 3: how to assess methodological limitations

BackgroundThe 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.MethodsWe 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.ResultsWhen 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.ConclusionsThis 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.

Challenging the Biopsychosocial Model in a Chronic Constipation Clinic

In this article we discuss the results of an ethnographic study of professionals’ and patients’ experiences within a specialist constipation clinic in England. Chronic constipation tends to be poorly understood and inadequately treated. Eleven patients were followed through their illness trajectory during a 5-month fieldwork period, involving 21 home interviews, clinic-based interviews, participant observation, and a focus group. Professionals were likewise observed and interviewed. The clinic could be broadly described as biopsychosocial in its approach. However, professionals expressed uncertainty about how best to provide biopsychosocial care and suggested that some patients were not “open” to psychosocial therapies or to discussing psychosocial aspects of their disease. Patients’ concerns were with being taken seriously, receiving treatment, and narrating intersections of life events, emotional well-being, and the bowels. We situate these findings within the discourse of “functional” disorders and discuss why implementing a biopsychosocial approach is problematic in this case.

Is a qualitative perspective missing from COPD guidelines

As researchers in the Centre for Medical Humanities we are interested in what the medical humanities and social sciences can contribute to the understanding and treatment of somatic illness. Our interest in the historical development of the disease entity known as COPD was born-out of ethnographic work carried out by the first author (MW) on COPD in Uruguay and is directed at future research on lay and medical concepts of the illness. We are interested in how, by widening our cultural—historical understandings of COPD, we may better interpret the clear evidence of a distinction between measured and experienced symptoms in this illness. To get to grips with how the current definition, treatment and management of COPD came to be, we decided to compare present and past national and international clinical guidelines.

Means and ENDS – e-cigarettes, the Framework Convention on Tobacco Control, and global health diplomacy in action

ABSTRACT E-cigarettes are a new and disruptive element in global health diplomacy (GHD) and policy-making. This is an ethnographic account of how e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS) were tackled at the 6th Conference of the Parties to the World Health Organizations Framework Convention on Tobacco Control. It demonstrates how uncertainty about ENDS and differences of opinion are currently so great that ‘agreeing to disagree’ as a consensus position and ‘strategic use of time’ were the principles that ensured effective GHD in this case. Observers representing accredited non-governmental organisations were active in briefing and lobbying country delegates not to spend too much time debating an issue for which insufficient evidence exists, and for which countries were unlikely to reach a consensus on a specific regulatory approach or universally applicable regulatory measures. Equally, the work of Costa Rica in preparing and re-negotiating the draft decision, and the work of the relevant Committee Chair in managing the discussion, contributed to effectively reining in lengthy statements from Parties and focusing on points of consensus. As well as summarising the debate itself and analysing the issues surrounding it, this account offers an example of GHD working effectively in a situation of epistemic uncertainty.