A review of patient and carer participation and the use of qualitative research in the development of core outcome sets

Abstract

BackgroundTo be meaningful, a core outcome set (COS) should be relevant to all stakeholders including patients and carers. This review aimed to explore the methods by which patients and carers have been included as participants in COS development exercises and, in particular, the use and reporting of qualitative methods.MethodsIn August 2015, a search of the Core Outcomes Measures in Effectiveness Trials (COMET) database was undertaken to identify papers involving patients and carers in COS development. Data were extracted to identify the data collection methods used in COS development, the number of health professionals, patients and carers participating in these, and the reported details of qualitative research undertaken.ResultsFifty-nine papers reporting patient and carer participation were included in the review, ten of which reported using qualitative methods. Although patients and carers participated in outcome elicitation for inclusion in COS processes, health professionals tended to dominate the prioritisation exercises. Of the ten qualitative papers, only three were reported as a clear pre-designed part of a COS process. Qualitative data were collected using interviews, focus groups or a combination of these. None of the qualitative papers reported an underpinning methodological framework and details regarding data saturation, reflexivity and resource use associated with data collection were often poorly reported. Five papers reported difficulty in achieving a diverse sample of participants and two reported that a large and varied range of outcomes were often identified by participants making subsequent rating and ranking difficult.ConclusionsConsideration of the best way to include patients and carers throughout the COS development process is needed. Additionally, further work is required to assess the potential role of qualitative methods in COS, to explore the knowledge produced by different qualitative data collection methods, and to evaluate the time and resources required to incorporate qualitative methods into COS development.

Patient and public involvement in the design of clinical trials: An overview of systematic reviews

“…Researchers are not evaluated as performance partners within research manuscripts, but their research is evaluated after peer reviewed publication and impact is evaluated by external parties. Research prioritization and the development of core outcome sets as stand‐alone exercises hinder widespread usage. DUETS UK previously provided a platform where those navigating public preferences, priorities, and research questions could find common ground, but DUETS was subsumed by NICE and not maintained .…”

A Core Outcome Set for Multimorbidity Research (COSmm)

“…This strategy also allowed for purposive selection of a panel to ensure representation of a range of stakeholders from different countries and health care systems with both professional and patient representation. 24 Panelists achieved a high level of consensus after the first round for 11 outcomes. The level seen is higher than might have been expected.…”

“…We used this approach to ensure that panelists could make independent judgments and avoid moving toward a group average score. 24 Guidance on the use of Delphi techniques recommends that a measure of distribution around final scores should be reported, which we have done. Reporting of the final scores alone can mask major disagreement within the group, which might be the case if there was a wide distribution around scores.…”

“…Another potential limitation of our study is that although we included panelists from 13 countries, all were based in high-income countries. In addition, although we included patient representatives as Delphi panel members, as for many previous core outcome set studies, 24 it is a limitation that they were not directly involved in the development of the initial COSmm.…”

Adding value to core outcome set development using multimethod systematic reviews

“…Although some COS teams do not actively engage public stakeholders in the identification of outcomes for the inventory, many will try to identify outcomes from parent/patient/public for the inventory. However, this tends to be done using stand‐alone, original qualitative research that can be expensive and time consuming, often only sampling a small and very specific population . Research that explores the perspectives, opinions, or experiences of the public should inform the range of outcome domains identified for COS development .…”