Developing core outcome sets for clinical research and guideline development - qualitative systematic reviews to increase the volume, depth and diversity of patient perspectives included.Tuberculosis: a case study.

Abstract

Background. Patient involvement is a core value of contemporary healthcare, and an emerging component of core outcome set (COS) methodology. This research pilots the use of qualitative systematic reviews to increase the volume, depth and diversity of patient perspectives included in COS development, specifically for a COS for tuberculosis (TB). A COS for TB will ensure that outcomes across trials are consistent, free from selection bias and relevant to patients, clinicians and policy-makers.Methods. ASSIA, CINAHL, Embase, MEDLINE and PsycINFO were searched for qualitative studies exploring patient perspectives on tuberculosis and its management. Studies were appraised using the CASP checklist and thematic synthesis utilised to identify treatment outcomes of potential importance to patients. The overall confidence in the review findings was assessed using the CERQual approach.The outcomes identified as important were compared against those used in planned and existing Cochrane reviews, and against those used in the new NICE guidance on TB, to investigate the need for future work to consider more patient-centred outcomes.In order to assess the potential value of adding qualitative evidence synthesis into COS methodology, the volume and diversity of patient perspectives incorporated in the review were compared against those included in published COS literature that utilised qualitative research in patient populations (without synthesis).Findings. Improvement in the signs and symptoms of disease, mortality and survival, treatment failure, success and cure, the adverse effects of treatment, and the impact of treatment on the patient's ability to function were identified as important to patients. The confidence in these review findings ranged from low to very low.These outcomes were not consistently reported in Cochrane reviews, nor in the primary studies included in these reviews. The outcomes were addressed to a greater extent in the reviews underpinning the updated NICE guidance. The impact of treatment on the patient's ability to function was not considered by any review.The use of qualitative systematic reviews improved the volume and diversity - the geographical coverage, the range of age groups and the balance of men and women - of patients' perspectives available when compared to the published COS literature.Conclusions. The outcomes identified in the review should be considered within the development of a core outcome set for TB, but also by those planning future trials into the effectiveness of antituberculosis treatments and future qualitative research into outcome prioritisation for TB trials. The research has provided a tentative rationale for the use of qualitative systematic reviews more widely within COS development. However, these benefits should be considered in light of a trade-off against the significant time and resource required in conducting a qualitative systematic review. More extensive use of these methods should perhaps wait until there is a greater volume of directly relevant qualitative research available.

Date of Award	31 Dec 2016
Original language	English
Awarding Institution	The University of Manchester
Supervisor	Tanya Walsh (Supervisor) & Anne-Marie Glenny (Supervisor)