Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery

Shelley Potter, Sara T Brookes, Christopher Holcombe, Joseph A Ward, Jane M Blazeby, Shelley Potter, Sara T Brookes, Christopher Holcombe, Joseph A Ward, Jane M Blazeby

Abstract

Background: The development and use of core outcome sets (COSs) in trials may improve data synthesis and reduce outcome reporting bias. The selection of outcomes in COSs is informed by views of key stakeholders, yet little is known about the role and influence of different stakeholders' views during COS development. We report an exploratory case study examining how stakeholder selection and incorporation of stakeholders' views may influence the selection of outcomes for a COS in reconstructive breast surgery (RBS). We also make recommendations for future considerations.

Methods: Key stakeholder groups and subgroups were identified from the literature and expert opinion by the COS management group. They included health care professionals, subdivided by profession (breast and plastic surgeons, specialist nurses and psychologists) and patients, subdivided according to type of surgery received, timing of reconstruction, time since surgery and patient age. All participated in a survey in which they were asked to prioritise outcomes. Outcomes were prioritised using a 9-point scale from 1 (not important) to 9 (extremely important). The proportion of (1) all participants, ignoring stakeholder group (single heterogeneous panel analysis), (2) 'professional' and 'patient' groups separately (two heterogeneous panels), ignoring prespecified subgroups and (3) each participant subgroup separately (multiple homogeneous panel analysis) rating each item 'extremely important' was summarised and compared to explore how selection and integration of stakeholder views may influence outcome prioritisation.

Results: There were many overlaps between items rated as most important by all groups. Specific stakeholders, however, prioritised specific concerns and a broader range of outcomes were prioritised when the subgroups were considered separately. For example, two additional outcomes were prioritised when patient and professional groups were considered separately and eight additional outcomes were identified when the views of the individual subgroups were explored. In general, patient subgroups preferentially valued additional clinical outcomes, including unplanned surgery, whereas professional subgroups prioritised additional psychosocial issues including body image.

Conclusion: Stakeholder groups value different outcomes. Selection of groups, therefore, is important. Our recommendations for robust and transparent stakeholder selection and integration of stakeholder views may aid future COS developers in the design and conduct of their studies and improve the validity and value of future COS.

Keywords: Breast reconstruction; Core outcome sets; Delphi; Methodology; Stakeholder selection.

References

    1. Williamson PR, Clarke M. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative: its role in improving Cochrane Reviews (editorial) Cochrane Database Syst Rev. 2013;3(5):ED000041.
    1. Williamson P, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy. 2012;17(1):1–2. doi: 10.1258/jhsrp.2011.011131.
    1. Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of . JAMA Intern Med. 2013;173(11):972–9. doi: 10.1001/jamainternmed.2013.627.
    1. Blencowe NS, Chana P, Whistance RN, Stevens D, Wong NACS, Falk SJ, Blazeby JM. Outcome reporting in neoadjuvant surgical trials: a systematic review of the literature and proposals for new standards. J Natl Cancer Inst. 2014;106(9). doi: 10.1093/jnci/dju217.
    1. Blencowe NS, Strong S, McNair AGK, Brookes ST, Crosby T, Griffin SM, Blazeby JM. Reporting of short-term clinical outcomes after esophagectomy: a systematic review. Ann Surg. 2012;255(4):658–66. doi: 10.1097/SLA.0b013e3182480a6a.
    1. Currie A, Brigic A, Blencowe NS, Potter S, Faiz OD, Kennedy RH, Blazeby JM. Systematic review of surgical innovation reporting in laparoendoscopic colonic polyp resection. Br J Surg. 2015;102(2):e108–16. doi: 10.1002/bjs.9675.
    1. Hopkins JC, Howes N, Chalmers K, Savovic J, Whale K, Coulman KD, Welbourn R, Whistance RN, Andrews RC, Byrne JP, et al. Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. Obes Rev. 2015;16(1):88–106. doi: 10.1111/obr.12240.
    1. Potter S, Brigic A, Whiting PF, Cawthorn SJ, Avery KN, Donovan JL, Blazeby JM. Reporting clinical outcomes of breast reconstruction: a systematic review. J Natl Cancer Inst. 2011;103(1):31–46. doi: 10.1093/jnci/djq438.
    1. Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials. 2007;8(1):39. doi: 10.1186/1745-6215-8-39.
    1. Williamson P, Altman D, Blazeby J, Clarke M, Devane D, Gargon E, Tugwell P. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132. doi: 10.1186/1745-6215-13-132.
    1. Kirkham J, Gorst S, Altman D, Blazeby J, Clarke M, Devane D, Gargon E, Williamson P, COS-STAR Group COS-STAR: a reporting guideline for studies developing core outcome sets (protocol) Trials. 2015;16(1):373. doi: 10.1186/s13063-015-0913-9.
    1. COMET Inititative. Core outcome measures in effectiveness trials. 2011. .
    1. Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, Williamson PR. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014;9(6):e99111. doi: 10.1371/journal.pone.0099111.
    1. Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O’Brien K, Bennett AMD, Chorbachi R, Hall PN, Harding-Bell A, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS One. 2015;10(6):e0129514. doi: 10.1371/journal.pone.0129514.
    1. Potter S, Holcombe C, Ward JA, Blazeby JM, the BSG Development of a core outcome set for research and audit studies in reconstructive breast surgery. Br J Surg. 2015;102(11):1360–71. doi: 10.1002/bjs.9883.
    1. Sinha IP, Smyth RL, Williamson PR. Using the Delphi Technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393. doi: 10.1371/journal.pmed.1000393.
    1. Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, Wales PW. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–09.
    1. Brookes ST, Macefield RC, Williamson PR, McNair AG, Potter S, Blencowe NS, Strong S, Blazeby JM. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials. 2016;17(1):1–14. doi: 10.1186/s13063-016-1479-x.
    1. Thiruchelvam PTR, McNeill F, Jallali N, Harris P, Hogben K. Post-mastectomy breast reconstruction. BMJ. 2013;347. doi: 10.1136/bmj.f5903.
    1. Potter S, Mills N, Cawthorn S, Blazeby J. Understanding decision-making for reconstructive breast surgery: a qualitative study. Eur J Surg Oncol. 2012;38(5):458. doi: 10.1016/j.ejso.2012.02.006.
    1. Potter S, Mills N, Cawthorn S, Wilson S, Blazeby J. Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study. Br J Cancer. 2013;109:1181–91. doi: 10.1038/bjc.2013.461.
    1. Wolf L. Part I: Decision making and sources of information. Eur J Oncol Nurs. 2004;8:211–23. doi: 10.1016/j.ejon.2003.12.012.
    1. Temple-Oberle C, Ayeni O, Webb C, Bettger-Hahn M, Ayeni O, Mychailyshyn N. Shared decision-making: applying a person-centered approach to tailored breast reconstruction information provides high satisfaction across a variety of breast reconstruction options. J Surg Oncol. 2014;110(7):796-800.
    1. Lee CN, Belkora J, Chang Y, Moy B, Partridge A, Sepucha K. Are patients making high-quality decisions about breast reconstruction after mastectomy? Plast Reconstr Surg. 2011;127(1):18–26.
    1. Alderman A, Hawley S, Morrow M, Salem B, Hamilton A, Graff J, Katz S. Receipt of delayed breast reconstruction after mastectomy: do women revisit the decision? Ann Surg Oncol. 2011;18(6):1748–56. doi: 10.1245/s10434-010-1509-y.
    1. Wolf L. The information needs of women who have undergone breast reconstruction, Part II: Information giving and content of information. Eur J Oncol Nurs. 2004;8:315–24. doi: 10.1016/j.ejon.2003.12.013.
    1. Potter S, Harcourt D, Cawthorn SJ, Warr R, Mills N, Havercroft D, Blazeby J. Assessment of cosmesis after breast reconstruction surgery: a systematic review. Ann Surg Oncol. 2011;18(3):813–23. doi: 10.1245/s10434-010-1368-6.
    1. Potter S, Mills N, Cawthorn S, Wilson S, Blazeby J. Exploring information provision in reconstructive breast surgery: a qualitative study. Breast. 2015;24(6):732–8. doi: 10.1016/j.breast.2015.09.003.
    1. Potter S, Mills N, Cawthorn S, Donovan J, Blazeby J. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials. 2014;15(1):80. doi: 10.1186/1745-6215-15-80.
    1. Potter S, Mills N, Cawthorn SJ, Blazeby J. Improving the patient journey in breast reconstruction: a qualitative study. Eur J Surg Oncol. 2012;38(5):426. doi: 10.1016/j.ejso.2012.02.057.
    1. Potter S. Investigating the feasibility of randomised clinical trials in breast reconstruction. University of Bristol; 2011.
    1. Mays N, Pope C. Qualitative research: rigour and qualitative research. BMJ. 1995;311(6997):109–12. doi: 10.1136/bmj.311.6997.109.
    1. Mays N, Pope C. Assessing quality in qualitative research. BMJ. 2000;320:50–2. doi: 10.1136/bmj.320.7226.50.
    1. Stata. 2009. . Accessed 19 Sept 2016.
    1. Schmitt J, Langan S, Stamm T, Williams HC, on behalf of the Harmonizing Outcome Measurements in Eczema Delphi panel Core outcome domains for controlled trials and clinical recordkeeping in eczema: International Multiperspective Delphi Consensus Process. J Invest Dermatol. 2011;131(3):623–30. doi: 10.1038/jid.2010.303.
    1. Kirwan JR, Minnock P, Adebajo A, Bresnihan B, Choy E, de Wit M, Hazes M, Richards P, Saag K, Suarez-Almazor M, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol. 2007;34(5):1174–7.
    1. Kirkham JJ, Boers M, Tugwell P, Clarke M, Williamson PR. Outcome measures in rheumatoid arthritis randomised trials over the last 50 years. Trials. 2013;14. doi: 10.1186/1745-6215-14-324.
    1. 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. doi: 10.1186/1745-6215-8-38.
    1. McNair A, Whistance R, Forsythe R, Macefield R, Rees J, Jones J, Smith G, Pullyblank A, Avery K, Brookes S, et al. The development of a colorectal cancer surgery core outcome set. Trials. 2015;16(Suppl 1):12. doi: 10.1186/1745-6215-16-S1-P12.
    1. Avery K, Chalmers K, Whale K, Blencowe N, Macefield R, Brookes S, Metcalfe C, Blazeby J. The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection. Trials. 2015;16(Suppl 2):47. doi: 10.1186/1745-6215-16-S2-P47.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel