Implications of a qualitative study on Core Outcome Set development

Abstract

Background: the use of qualitative methods within Core Outcome Set (COS) development has been recognised as a potentially beneficial methodological innovation. Although preliminary guidance on the use of qualitative methods as a pre-Delphi stage in COS development has been published, additional appraisal on the use of this novel approach is still encouraged. The present study reports on the implications of a qualitative study on the development of a COS to evaluate physical activity interventions for people with dementia, across different stages of the condition and intervention settings.

Methods: in-depth qualitative interviews (n=29) were conducted with people with dementia, their family carers and health professionals. Data were analysed thematically and the outcomes identified in the interviews were compared against those reported in a previous literature review. Interview data was also used to define the scope of each outcome domain. Possible implications of this qualitative study on the development of the COS were identified.

Results: the present qualitative study generated 10 new outcomes; nine outcomes were identified in previous literature, but not in this qualitative study. A final list of 77 outcomes was generated to be used in the Delphi stage. A glossary was also developed based on these qualitative findings, clearly defining the scope of each domain prior to the Delphi. The large majority of outcomes were mentioned by participants across stages of dementia. Thus the COS protocol was changed from a Delphi survey subdivided per stages of dementia, to a single Delphi survey common to all stages.

Conclusions: qualitative studies can generate new outcomes to those generated through literature reviews, and they can be paramount in defining the scope of each outcome pre-Delphi. Qualitative studies can inform the structure of COS, by providing an in-depth understanding of how outcomes can be meaningful across stages of disease progression.

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Identifiers

ORCID for Ana Carolina, Vieira Goncalves: orcid.org/0000-0003-4055-0894

ORCID for Dinesh Samuel: orcid.org/0000-0003-3610-8032

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