Improving Core Outcome Set Development: Qualitative Interviews with Developers Provided Pointers to Inform Guidance

Overview

Journal J Clin Epidemiol

Publisher Elsevier

Specialty Public Health

Date 2017 May 13

PMID 28495644

Citations 23

Authors

Elizabeth Gargon

Paula R Williamson

Bridget Young

Affiliations

Soon will be listed here.

Abstract

Objectives: The objective of the study was to explore core outcome set (COS) developers' experiences of their work to inform methodological guidance on COS development and identify areas for future methodological research.

Study Design And Setting: Semistructured, audio-recorded interviews with a purposive sample of 32 COS developers. Analysis of transcribed interviews was informed by the constant comparative method and framework analysis.

Results: Developers found COS development to be challenging, particularly in relation to patient participation and accessing funding. Their accounts raised fundamental questions about the status of COS development and whether it is consultation or research. Developers emphasized how the absence of guidance had affected their work and identified areas where guidance or evidence about COS development would be useful including, patient participation, ethics, international development, and implementation. They particularly wanted guidance on systematic reviews, Delphi, and consensus meetings.

Conclusion: The findings raise important questions about the funding, status, and process of COS development and indicate ways that it could be strengthened. Guidance could help developers to strengthen their work, but over specification could threaten quality in COS development. Guidance should therefore highlight common issues to consider and encourage tailoring of COS development to the context and circumstances of particular COS.

Citing Articles

Uptake of core outcome sets in paediatric clinical trials: a protocol.

Lei R, Estill J, Florez I, Li Q, Chen Y, Williamson P BMJ Paediatr Open. 2025; 9(1).

PMID: 40032589 PMC: 11877272. DOI: 10.1136/bmjpo-2024-003054.

Assessment of the methodological quality of studies on core outcome sets for respiratory diseases: A systematic review and meta-research study.

Liu M, Wang J, Wang L, Zhang X, Hao R, Wang D PLoS One. 2025; 20(1):e0316670.

PMID: 39746037 PMC: 11695018. DOI: 10.1371/journal.pone.0316670.

'Without the Data You're Not Going to Know If It's Important or Not': A Mixed Methods Study on What Dysphagia Intervention Outcomes are Important to People with Parkinson's Disease and Family Members.

Hirschwald J, Mooney L, Wolf M, Boyle G, Warnecke T, Walshe M Dysphagia. 2024; .

PMID: 39644337 DOI: 10.1007/s00455-024-10788-x.

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

Quirke F, Ariff S, Battin M, Bernard C, Biesty L, Bloomfield F Pediatr Res. 2023; 95(4):922-930.

PMID: 38135724 PMC: 10920183. DOI: 10.1038/s41390-023-02938-y.

To adopt or adapt an existing neonatal core outcome set in Kenya: a study protocol.

Karumbi J, Gathara D, Young B, Williamson P Trials. 2023; 24(1):806.

PMID: 38102720 PMC: 10722714. DOI: 10.1186/s13063-023-07821-z.

References

Barbour R . Checklists for improving rigour in qualitative research: a case of the tail wagging the dog?. BMJ. 2001; 322(7294):1115-7. PMC: 1120242. DOI: 10.1136/bmj.322.7294.1115. View

Daly J, Willis K, Small R, Green J, Welch N, Kealy M . A hierarchy of evidence for assessing qualitative health research. J Clin Epidemiol. 2006; 60(1):43-9. DOI: 10.1016/j.jclinepi.2006.03.014. View

Salmon P, Peters S, Rogers A, Gask L, Clifford R, Iredale W . Peering through the barriers in GPs' explanations for declining to participate in research: the role of professional autonomy and the economy of time. Fam Pract. 2007; 24(3):269-75. DOI: 10.1093/fampra/cmm015. View

Tong A, Sainsbury P, Craig J . Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007; 19(6):349-57. DOI: 10.1093/intqhc/mzm042. View

Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L . OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials. 2007; 8:38. PMC: 2169260. DOI: 10.1186/1745-6215-8-38. View

Dwan K, Altman D, Arnaiz J, Bloom J, Chan A, Cronin E . Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008; 3(8):e3081. PMC: 2518111. DOI: 10.1371/journal.pone.0003081. View

Chalmers I, Glasziou P . Avoidable waste in the production and reporting of research evidence. Lancet. 2009; 374(9683):86-9. DOI: 10.1016/S0140-6736(09)60329-9. View

Reddel H, Taylor D, Bateman E, Boulet L, Boushey H, Busse W . An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009; 180(1):59-99. DOI: 10.1164/rccm.200801-060ST. View

Stige B, Malterud K, Midtgarden T . Toward an agenda for evaluation of qualitative research. Qual Health Res. 2009; 19(10):1504-16. DOI: 10.1177/1049732309348501. View

10.

Erkut S . Developing Multiple Language Versions of Instruments for Intercultural Research. Child Dev Perspect. 2011; 4(1):19-24. PMC: 3060794. DOI: 10.1111/j.1750-8606.2009.00111.x. View

11.

Miyar J, Adams C . Content and quality of 10,000 controlled trials in schizophrenia over 60 years. Schizophr Bull. 2012; 39(1):226-9. PMC: 3523927. DOI: 10.1093/schbul/sbr140. View

12.

Busse W, Morgan W, Taggart V, Togias A . Asthma outcomes workshop: overview. J Allergy Clin Immunol. 2012; 129(3 Suppl):S1-8. PMC: 4259286. DOI: 10.1016/j.jaci.2011.12.985. View

13.

Sinha I, Gallagher R, Williamson P, Smyth R . Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012; 13:103. PMC: 3433381. DOI: 10.1186/1745-6215-13-103. View

14.

Hirsch B, Califf R, Cheng S, Tasneem A, Horton J, Chiswell K . Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med. 2013; 173(11):972-9. DOI: 10.1001/jamainternmed.2013.627. View

15.

Gale N, Heath G, Cameron E, Rashid S, Redwood S . Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013; 13:117. PMC: 3848812. DOI: 10.1186/1471-2288-13-117. View

16.

Chan A, Song F, Vickers A, Jefferson T, Dickersin K, Gotzsche P . Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014; 383(9913):257-66. PMC: 4533904. DOI: 10.1016/S0140-6736(13)62296-5. View

17.

Gargon E, Gurung B, Medley N, Altman D, Blazeby J, Clarke M . Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014; 9(6):e99111. PMC: 4059640. DOI: 10.1371/journal.pone.0099111. View

18.

OBrien B, Harris I, Beckman T, Reed D, Cook D . Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014; 89(9):1245-51. DOI: 10.1097/ACM.0000000000000388. View

19.

Kirkham J, Gorst S, Altman D, Blazeby J, Clarke M, Devane D . COS-STAR: a reporting guideline for studies developing core outcome sets (protocol). Trials. 2015; 16:373. PMC: 4546355. DOI: 10.1186/s13063-015-0913-9. View

20.

Gargon E, Williamson P, Altman D, Blazeby J, Clarke M . The COMET initiative database: progress and activities update (2014). Trials. 2015; 16:515. PMC: 4642751. DOI: 10.1186/s13063-015-1038-x. View