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 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.

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.

Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial.

BACKGROUND: Frailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD. METHODS: Participants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability. RESULTS: Six hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence. CONCLUSIONS: This pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD. TRIAL REGISTRATION: ISRCTN87708989; https://clinicaltrials.gov/.

Qualitative meta-synthesis: a guide for the novice.

The emerging field of qualitative synthesis is an exciting area of research with the potential to influence policy and practice. It is also saturated with a variety of unresolved philosophical, terminological and methodological discussions which may seem daunting to the novice researcher This article by Kenneth Finlayson and Annie Dixon attempts to clarify some of the more controversial issues and, by providing a set of guidelines, hopes to encourage novices to enter this stimulating environment with confidence and understanding.