Women's experiences of psychological treatment and psychosocial interventions for postpartum depression: a qualitative systematic review and meta-synthesis.

BACKGROUND: To provide a comprehensive, systematic evaluation of the literature on experiences of psychological interventions for postpartum depression (PPD) in women. Depression is one of the most common postpartum mental disorders. Studies have identified that psychological interventions reduce depressive symptoms. However, less is known about the experiences of women who have received such treatments. METHODS: A systematic review of the literature was conducted by searching five databases (CINAHL, Cochrane Library, EMBASE, Medline, PsycINFO), in August 2022. Studies with qualitative methodology examining women's experiences of professional treatment for PPD were included and checked for methodological quality. Eight studies (total N = 255) contributed to the findings, which were synthesized using thematic synthesis. Confidence in the synthesized evidence was assessed with GRADE CERQual. FINDINGS: The women had received cognitive behavioral therapy (5 studies) or supportive home visits (3 studies). Treatments were individual or group-based. Two main themes were identified: Circumstances and expectations, and Experiences of treatment, with six descriptive themes. Establishing a good relationship to their health professional was important for the women, regardless of treatment model. They also expressed that they wanted to be able to choose the type and format of treatment. The women were satisfied with the support and treatment received and expressed that their emotional well-being had been improved as well as the relationship to their infant. CONCLUSION: The findings can be helpful to develop and tailor patient-centered care for women who are experiencing postnatal depression.

The use of GRADE-CERQual in qualitative evidence synthesis: an evaluation of fidelity and reporting.

BACKGROUND: GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative Research) is a methodological approach to systematically and transparently assess how much confidence decision makers can place in individual review findings from qualitative evidence syntheses. The number of reviews applying GRADE-CERQual is rapidly expanding in guideline and other decision-making contexts. The objectives of this evaluation were, firstly, to describe the uptake of GRADE-CERQual in qualitative evidence synthesis by review authors and, secondly, to assess both reporting of and fidelity to the approach. METHODS: The evaluation had two parts. Part 1 was a citation analysis and descriptive overview of the literature citing GRADE-CERQual. Authors worked together to code and chart the citations, first by title and abstract and second by full text. Part 2 was an assessment and analysis of fidelity to, and reporting of, the GRADE-CERQual approach in included reviews. We developed fidelity and reporting questions and answers based on the most recent guidance for GRADE-CERQual and then used NVivo12 to document assessments in a spreadsheet and code full-text PDF articles for any concerns that had been identified. Our assessments were exported to Excel and we applied count formulae to explore patterns in the data. We employed a qualitative content analysis approach in NVivo12 to sub-coding all the data illustrating concerns for each reporting and fidelity criteria. RESULTS: 233 studies have applied the GRADE-CERQual approach, with most (n = 225, 96.5%) in the field of health research. Many studies (n = 97/233, 41.6%) were excluded from full fidelity and reporting assessment because they demonstrated a serious misapplication of GRADE-CERQual, for example interpreting it as a quality appraisal tool for primary studies or reviews. For the remaining studies that applied GRADE-CERQual to assess confidence in review findings, the main areas of reporting concern involved terminology, labelling and completeness. Fidelity concerns were identified in more than half of all studies assessed. CONCLUSIONS: GRADE-CERQual is being used widely within qualitative evidence syntheses and there are common reporting and fidelity issues. Most of these are avoidable and we highlight these as gaps in knowledge and guidance for applying the GRADE-CERQual approach.

The TRANSFER Approach for assessing the transferability of systematic review findings.

BACKGROUND: Systematic reviews are a key input to health and social welfare decisions. Studies included in systematic reviews often vary with respect to contextual factors that may impact on how transferable review findings are to the review context. However, many review authors do not consider the transferability of review findings until the end of the review process, for example when assessing confidence in the evidence using GRADE or GRADE-CERQual. This paper describes the TRANSFER Approach, a novel approach for supporting collaboration between review authors and stakeholders from the beginning of the review process to systematically and transparently consider factors that may influence the transferability of systematic review findings. METHODS: We developed the TRANSFER Approach in three stages: (1) discussions with stakeholders to identify current practices and needs regarding the use of methods to consider transferability, (2) systematic search for and mapping of 25 existing checklists related to transferability, and (3) using the results of stage two to develop a structured conversation format which was applied in three systematic review processes. RESULTS: None of the identified existing checklists related to transferability provided detailed guidance for review authors on how to assess transferability in systematic reviews, in collaboration with decision makers. The content analysis uncovered seven categories of factors to consider when discussing transferability. We used these to develop a structured conversation guide for discussing potential transferability factors with stakeholders at the beginning of the review process. In response to feedback and trial and error, the TRANSFER Approach has developed, expanding beyond the initial conversation guide, and is now made up of seven stages which are described in this article. CONCLUSIONS: The TRANSFER Approach supports review authors in collaborating with decision makers to ensure an informed consideration, from the beginning of the review process, of the transferability of the review findings to the review context. Further testing of TRANSFER is needed.

Qualitative Evidence Synthesis (QES) for Guidelines: Paper 1 - Using qualitative evidence synthesis to inform guideline scope and develop qualitative findings statements.

BACKGROUND: WHO has recognised the need to ensure that guideline processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable. Along with decision-making criteria that require findings from effectiveness reviews, WHO is increasingly using evidence derived from qualitative evidence syntheses (QES) to inform the values, acceptability, equity and feasibility implications of its recommendations. This is the first in a series of three papers examining the use of QES in developing clinical and health systems guidelines. METHODS: WHO convened a group of methodologists involved in developing recent (2010-2018) guidelines that were informed by QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. Our aim in this paper is to (1) describe and discuss how the findings of QES can inform the scope of a guideline and (2) develop findings for key guideline decision-making criteria. RESULTS: QES resulted in the addition of new outcomes that are directly relevant to service users, a stronger evidence base for decisions about how much effective interventions and related outcomes are valued by stakeholders in a range of contexts, and a more complete database of summary evidence for guideline panels to consider, linked to decisions about values, acceptability, feasibility and equity. CONCLUSIONS: Rigorously conducted QES can be a powerful means of improving the relevance of guidelines, and of ensuring that the concerns of stakeholders, at all levels of the healthcare system and from a wide range of settings, are taken into account at all stages of the process.

Qualitative Evidence Synthesis (QES) for Guidelines: Paper 2 - Using qualitative evidence synthesis findings to inform evidence-to-decision frameworks and recommendations.

BACKGROUND: WHO has recognised the need to improve its guideline methodology to ensure that guideline decision-making processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable. To help achieve this, WHO guidelines now typically enhance intervention effectiveness data with evidence on a wider range of decision-making criteria, including how stakeholders value different outcomes, equity, gender and human rights impacts, and the acceptability and feasibility of interventions. Qualitative evidence syntheses (QES) are increasingly used to provide evidence on this wider range of issues. In this paper, we describe and discuss how to use the findings from QES to populate decision-making criteria in evidence-to-decision (EtD) frameworks. This is the second in a series of three papers that examines the use of QES in developing clinical and health system guidelines. METHODS: WHO convened a writing group drawn from the technical teams involved in its recent (2010-2018) guidelines employing QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. RESULTS: We describe a step-wise approach to populating EtD frameworks with QES findings. This involves allocating findings to the different EtD criteria (how stakeholders value different outcomes, equity, acceptability and feasibility, etc.), weaving the findings into a short narrative relevant to each criterion, and inserting this summary narrative into the corresponding 'research evidence' sections of the EtD. We also identify areas for further methodological research, including how best to summarise and present qualitative data to groups developing guidelines, how these groups draw on different types of evidence in their decisions, and the extent to which our experiences are relevant to decision-making processes in fields other than health. CONCLUSIONS: This paper shows the value of incorporating QES within a guideline development process, and the roles that qualitative evidence can play in integrating the views and experiences of relevant stakeholders, including groups who may not be otherwise represented in the decision-making process.

Qualitative Evidence Synthesis (QES) for Guidelines: Paper 3 - Using qualitative evidence syntheses to develop implementation considerations and inform implementation processes.

BACKGROUND: This is the third in a series of three papers describing the use of qualitative evidence syntheses (QES) to inform the development of clinical and health systems guidelines. WHO has recognised the need to improve its guideline methodology to ensure that decision-making processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable to end users. In addition to the standard data on effectiveness, WHO guidelines increasingly use evidence derived from QES to provide information on acceptability and feasibility and to develop important implementation considerations. METHODS: WHO convened a group drawn from the technical teams involved in formulating recent (2010-2018) guidelines employing QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. As members of WHO guideline technical teams, our aim in this paper is to explore how we have used findings from QES to develop implementation considerations for these guidelines. RESULTS: For each guideline, in addition to using systematic reviews of effectiveness, the technical teams used QES to gather evidence of the acceptability and feasibility of interventions and, in some cases, equity issues and the value people place on different outcomes. This evidence was synthesised using standardised processes. The teams then used the QES to identify implementation considerations combined with other sources of information and input from experts. CONCLUSIONS: QES were useful sources of information for implementation considerations. However, several issues for further development remain, including whether researchers should use existing health systems frameworks when developing implementation considerations; whether researchers should take confidence in the evidence into account when developing implementation considerations; whether qualitative evidence that reveals implementation challenges should lead guideline panels to make conditional recommendations or only point to implementation considerations; and whether guideline users find it helpful to have challenges pointed out to them or whether they also need solutions. Finally, we need to explore how QES findings can be incorporated into derivative products to aid implementation.

Recommendations for Off-Label Drug Use in Ophthalmology in China: A Clinical Practice Guideline.

Off-label drugs use is widespread in ophthalmology due to the delay in drug approvals and package inserts update. It has been found to vary among different medical institutions in China, leading to safety problems since inappropriate use. Guidance is urgently needed regarding how best to use the drugs for unapproved indications and routes of administration. We aimed to develop an evidence-based guideline to guide off-label drugs used in ophthalmology in China. The practice guideline was developed by the Hospital Pharmacy Professional Committee, Chinese Pharmaceutical Association, following the WHO handbook for guideline development. The guideline was initially registered in the International Practice Guidelines Registry Platform (IPGRP-2021CN096). The clinical questions included in the guideline were identified through a three-round Delphi vote. Databases search was performed in PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, Chinese National Knowledge Infrastructure, and WanFang Database from their inception to 31 March 2021. Systematic reviews and meta-analyses for each clinical question were conducted individually to synthesize available scientific evidence. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and grade the recommendations' strengths. The multidisciplinary guideline groups were set up, including ophthalmologists, pharmacists, methodology experts, pharmacologists, pharmacoeconomists, and lawyers. The guideline identified 25 clinical questions included. A total of 32 systematic reviews, including 24 conducted by the systematic review group and eight high-relevance published within 2 years, were referred to address these questions. Finally, the guideline presented 32 recommendations addressing 25 clinical questions, involving five strong recommendations and 27 weak recommendations for the treatment of ocular fundus, corneal disease, glaucoma, and endophthalmitis. Current evidence from clinical studies supports the off-label drugs used in ophthalmology. We developed an evidence-based guideline using a rigorous multidisciplinary approach to guide these usages in route clinical practice.

Subsequent full publication of qualitative studies presented at United Kingdom Royal College of Nursing Research Conference 2015 and 2016: A follow-up study.

A considerable proportion of quantitative research remains unpublished once completed. Little research has documented non-dissemination and dissemination bias in qualitative research. This study aimed to generate evidence on the extent of non-dissemination in qualitative research. We followed a cohort of qualitative studies presented as conference abstracts to ascertain their subsequent publication status. We searched for subsequent full publication in MEDLINE, in the Cumulative Index to Nursing & Allied Health Literature and in Google Scholar. We matched abstracts to subsequent publications according to authors, method of data collection and phenomenon of interest. Fisher's exact test was calculated to examine associations between study characteristics and publication. Factors potentially associated with time to publication were evaluated with Cox regression analysis. For 91 of 270 included abstracts (33.70%; 95% CI 28.09%-39.68%), no full publication was identified. Factors that were found to be associated with subsequent full publication were oral presentation (OR 4.62; 95% CI 2.43-8.94) and university affiliation (OR 1.96; 95% CI 1.05-3.66). Compared to oral presentations, studies presented as posters took longer time to reach full publication (hazard ratio 0.35, 95% CI 0.21-0.58). This study shows that it was not possible to retrieve a full publication for over one-third of abstracts. Our findings suggest that where this non-dissemination is systematic, it may lead to distortions of the qualitative evidence-base for decision-making through dissemination bias. Our findings are congruent with those of other studies. Further research might investigate non-dissemination of qualitative studies in other disciplines to consolidate our findings.

Cochrane Qualitative and Implementation Methods Group guidance series-paper 3: methods for assessing methodological limitations, data extraction and synthesis, and confidence in synthesized qualitative findings.

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.

Hand hygiene among healthcare workers: A qualitative meta summary using the GRADE-CERQual process.

BACKGROUND: Hand hygiene is considered an effective and potentially modifiable infection control behaviour among healthcare workers (HCW). Several meta-studies have been published that compare quantitatively expressed findings, but limited efforts have been made to synthesise qualitative research. OBJECTIVES: This paper provides the first report of integrated findings from qualitative research reports on hand hygiene compliance among HCW worldwide that employs the GRADE-CERQual process of quality assessment. METHODS: We conducted database searches and identified 36 reports in which authors conducted qualitative or mixed methods research on hand hygiene compliance among HCW. We used Dedoose analysis software to facilitate extraction of relevant excerpts. We applied the GRADE-CERQual process to describe relative confidence as high, moderate or low for nine aggregate findings. FINDINGS: Highest confidence findings included that HCW believe they have access to adequate training, and that management and resource support are sometimes lacking. Individual, subjective criteria also influence hand hygiene. DISCUSSION: These results suggest the need for further investigation into healthcare cultures that are perceived as supportive for infection control. Surveillance processes have potential, especially if information is perceived by HCW as timely and relevant.

Expanding the evidence base for global recommendations on health systems: strengths and challenges of the OptimizeMNH guidance process.

BACKGROUND: In 2012, the World Health Organization (WHO) published recommendations on the use of optimization or "task-shifting" strategies for key, effective maternal and newborn interventions (the OptimizeMNH guidance). When making recommendations about complex health system interventions such as task-shifting, information about the feasibility and acceptability of interventions can be as important as information about their effectiveness. However, these issues are usually not addressed with the same rigour. This paper describes our use of several innovative strategies to broaden the range of evidence used to develop the OptimizeMNH guidance. In this guidance, we systematically included evidence regarding the acceptability and feasibility of relevant task-shifting interventions, primarily using qualitative evidence syntheses and multi-country case study syntheses; we used an approach to assess confidence in findings from qualitative evidence syntheses (the Grading of Recommendations, Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative Research (GRADE-CERQual) approach); we used a structured evidence-to-decision framework for health systems (the DECIDE framework) to help the guidance panel members move from the different types of evidence to recommendations. RESULTS: The systematic inclusion of a broader range of evidence, and the use of new guideline development tools, had a number of impacts. Firstly, this broader range of evidence provided relevant information about the feasibility and acceptability of interventions considered in the guidance as well as information about key implementation considerations. However, inclusion of this evidence required more time, resources and skills. Secondly, the GRADE-CERQual approach provided a method for indicating to panel members how much confidence they should place in the findings from the qualitative evidence syntheses and so helped panel members to use this qualitative evidence appropriately. Thirdly, the DECIDE framework gave us a structured format in which we could present a large and complex body of evidence to panel members and end users. The framework also prompted the panel to justify their recommendations, giving end users a record of how these decisions were made. CONCLUSIONS: By expanding the range of evidence assessed in a guideline process, we increase the amount of time and resources required. Nevertheless, the WHO has assessed the outputs of this process to be valuable and is currently repeating the approach used in OptimizeMNH in other guidance processes.