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Clin Obes. 2022 Feb;12(1):e12489. doi: 10.1111/cob.12489. Epub 2021 Oct 07.

The development of a core outcomes set for self-management interventions for patients living with obesity.

Clinical obesity

Claudia Valli, Rosa Suñol, Carola Orrego, Ena Niño de Guzmán, Valentina Strammiello, Nina Adrion, Kaisa Immonen, Lyudmil Ninov, Marieke van der Gaag, Marta Ballester, Pablo Alonso-Coello

Affiliations

  1. Iberoamerican Cochrane Centre Barcelona-Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
  2. Department of Paediatrics, Obstetrics, Gynaecology and Preventive Medicine, Universidad Autónoma de Barcelona, Barcelona, Spain.
  3. Universitat Autònoma de Barcelona, Barcelona, Spain.
  4. Avedis Donabedian Research Institute (FAD), Spain.
  5. Red de investigación en servicios de salud en enfermedades crónicas (REDISSEC), Barcelona, Spain.
  6. Cancer Prevention and Control Programme, Catalan Institute of Oncology, IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.
  7. European Patients' Forum (EPF), Brussels, Belgium.
  8. OptiMedis AG, Hamburg, Germany.
  9. Netherlands Institute for Health Services Research (Nivel), The Netherlands.
  10. CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

PMID: 34617681 DOI: 10.1111/cob.12489

Abstract

Self-management interventions (SMIs) can improve the life of patients living with obesity. However, there is variability in the outcomes used to assess the effectiveness of SMIs and these are often not relevant for patients. In the context of COMPAR-EU, our aim was to develop a core outcome set (COS) for the evaluation of SMIs for patients with obesity. We followed a four steps multimethod approach: (1) the development of the initial catalogue of outcomes; (2) a scoping review of reviews on patients' values and preferences on outcomes of self-management (SM); (3) a Delphi survey including patients and patient representatives to rate the importance of outcomes; and (4) a 2-day consensus workshop with patients, patient representatives, healthcare professionals and researchers. The initial catalogue included 82 outcomes. Ten patients and patient's representatives participated in the Delphi survey. We identified 16 themes through the thematic synthesis of the scoping review that informed 37.80% of the outcomes on initial catalogue. Five patients, five healthcare professionals, and four researchers participated in the consensus workshop. After the consensus process, 15 outcomes were selected to be part of the final COS, and five supplementary outcomes were also provided. We developed a COS for the evaluation of SMIs in obesity with a significant involvement of patients and other key stakeholders. This COS will help improving data synthesis and increasing the value of SM research data in healthcare decision making.

© 2021 The Authors. Clinical Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.

Keywords: core outcome set; obesity; patients; self-management interventions

References

  1. World Health Organisation. Obesity and overweight. Accessed May 13, 2020. https://www.who.int/en/news-room/fact-sheets/detail/obesity-and-overweight - PubMed
  2. Kyrou I, Randeva SH, Tsigos C, Grigorios Kaltsas G, Weickert OM. Clinical problems caused by obesity. In: Feingold KR, Anawalt B, Boyce A, et al., eds. Endotext. MDText.com, Inc.; 2000. - PubMed
  3. Atlantis E, Baker M. Obesity effects on depression: systematic review of epidemiological studies. Int J Obes (Lond). 2008;32:881-891. - PubMed
  4. Puhl RM, Moss-Racusin CA, Schwartz MB, Brownell KD. Weight stigmatization and bias reduction: perspectives of overweight and obese adults. Health Educ Res. 2008;23:347-358. - PubMed
  5. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1-7. - PubMed
  6. Ballester M, Orrego C, Heijmans M, et al. Comparing the effectiveness and cost-effectiveness of self-management interventions in four high-priority chronic conditions in Europe (COMPAR-EU): a research protocol. BMJ Open. 2020;10(1):e034680. - PubMed
  7. Schulman-Green D, Jaser S, Martin F, et al. Processes of self-management in chronic illness. J Nurs Scholarsh. 2012;44(2):136-144. - PubMed
  8. Tattersall RL. The expert patient: a new approach to chronic disease management for the twenty-first century. Clin Med (Lond). 2002;2(3):227-229. - PubMed
  9. Hartmann-Boyce J, Johns DJ, Jebb SA, Summerbell C, Aveyard P, Behavioural Weight Management Review Group. Behavioural weight management programmes for adults assessed by trials conducted in everyday contexts: systematic review and meta-analysis. Obes Rev. 2014;15(11):920-932. - PubMed
  10. Chiarotto A, Terwee CB, Deyo RA, et al. A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set. Trials. 2014;15:511. - PubMed
  11. Young B, Bagley H. Including patients in core outcome set development: issues to consider based on three workshops with around 100 international delegates. Res Involv Engagem. 2016;2:25. - PubMed
  12. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132. - PubMed
  13. Moloney RM, Messner DA, Tunis SR. The increasing complexity of the core outcomes landscape. J Clin Epidemiol. 2019;116:150-154. - PubMed
  14. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1.0. Trials. 2017;18(suppl 3):280. - PubMed
  15. Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-STAndards for reporting: the COS-STAR statement. PLoS Med. 2016;13(10):e1002148. - PubMed
  16. Webbe J, Brunton G, Ali S, Duffy JM, Modi N, Gale C. Developing, implementing and disseminating a core outcome set for neonatal medicine. BMJ Paediatr Open. 2017;1(1):e000048. https://doi.org/10.1136/bmjpo-2017-000048 - PubMed
  17. Schlessinger DI, Iyengar S, Yanes AF, et al. Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2017;18(1):4-9. - PubMed
  18. EU-PROSTEP Project Promoting Self-Management for Chronic Diseases in the EU-PROSTEP Project. European Commission. Pilot project on the promotion of self-care in chronic diseases in the European Union. Final report 2018. Accessed September 14, 2020. https://www.eu-patient.eu/globalassets/projects/prostep/pro-step-final-report.pdf - PubMed
  19. EMPATHiE Consortium. EMPATHiE Empowering patients in the management of chronic diseases. Final summary report. 2014. Accessed September 14, 2020. https://ehff.eu/wp-content/uploads/2015/10/empathie_frep_en.pdf - PubMed
  20. Orrego C, Ballester M, Pacheco-Barrios K, et al. Development and external validation of a comprehensive taxonomy of self-management interventions in chronic conditions: the COMPAR-EU taxonomy. 2019. Accessed September 14, 2020. https://self-management.eu/wp-content/uploads/2019/11/7863_Taxonomy_GIN_Poster.pdf. - PubMed
  21. Arksey H, O'Malley L. Scoping studies: towards a methodological Frascoping mework. Int J Soc. 2005;8(1):19-32. - PubMed
  22. Selva A, Sola I, Zhang Y, et al. Development and use of a content search strategy for retrieving studies on patients' views and preferences. Health Qual Life Outcomes. 2017;15(1):126. - PubMed
  23. Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol. 2008;8(1):45. - PubMed
  24. Campbell R, Pound P, Morgan M, et al. Evaluating meta-ethnography: systematic analysis and synthesis of qualitative research. Health Technol Assess. 2011;15(43):1-164. - PubMed
  25. Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. Pract Assess Res Eval. 2007;12:10. - PubMed
  26. Akins RB, Tolson H, Cole BR. Stability of response characteristics of a Delphi panel: application of bootstrap data expansion. BMC Med Res Methodol. 2005;5:37. - PubMed
  27. Coulman KD, Hopkins J, Brookes ST, et al. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project. PLoS Med. 2016;13(11):e1002187. - PubMed
  28. Weigl M, Cieza A, Andersen C, Kollerits B, Amann E, Stucki G. Identification of relevant ICF categories in patients with chronic health conditions: a Delphi exercise. J Rehabil Med. 2004;36(suppl 44):12-21. - PubMed
  29. Coulman KD, Abdelrahman T, Owen-Smith A, Andrews RC, Welbourn R, Blazeby JM. Patient-reported outcomes in bariatric surgery: a systematic review of standards of reporting. Obes Rev. 2013;14(9):707-720. - PubMed
  30. Hopkins JC, Howes N, Chalmers K, 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. - PubMed
  31. Anderson JW. Clinical trial design for obesity agents: a workshop report. Obes Res. 1998;6(4):311-315. - PubMed
  32. Garip G, Yardley L. A synthesis of qualitative research on overweight and obese people's views and experiences of weight management. Clin Obes. 2011;1(2-3):110-126. - PubMed
  33. Ohsiek S, Williams M. Psychological factors influencing weight loss maintenance: an integrative literature review. J Am Acad Nurse Prac. 2011;23(11):592-601. - PubMed
  34. Henderson E. Obesity in primary care: a qualitative synthesis of patient and practitioner perspectives on roles and responsibilities. Br J Gen Pract. 2015;65(633):e240-e247. - PubMed
  35. Mold F, Forbes A. Patients' and professionals' experiences and perspectives of obesity in health-care settings: a synthesis of current research. Health Expect. 2013;16(2):119-142. - PubMed
  36. Archibald D, Douglas F, Hoddinott P. A qualitative evidence synthesis on the management of male obesity. BMJ Open. 2015;5:e008372. - PubMed
  37. Lyzwinski LN, Caffery LJ, Bambling M, Edirippulige S. Consumer perspectives on mHealth for weight loss: a review of qualitative studies. J Telemed Telecare. 2018;24(4):290-302. - PubMed
  38. Doyle S, Lloyd A, Moore L, Ray J, Gray A. A systematic review and critical assessment of health state utilities: weight change and type 2 diabetes mellitus. Pharmacoeconomics. 2012;30(12):1133-1143. - PubMed
  39. McIntosh T, Hunter DJ, Royce S. Barriers to physical activity in obese adults: a rapid evidence assessment. J Res Nurs. 2016;21(4):271-287. - PubMed
  40. Greaves C, Poltawski L, Garside R, Briscoe S. Understanding the challenge of weight loss maintenance: a systematic review and synthesis of qualitative research on weight loss maintenance. Health Psychol Rev. 2017;11(2):145-163. - PubMed
  41. Malterud K, Ulriksen K. Obesity, stigma, and responsibility in health care: a synthesis of qualitative studies. Int J Qual Stud Health Well-Being. 2011;6(4):8404. - PubMed
  42. Papadopoulos S, Brennan L. Correlates of weight stigma in adults with overweight and obesity: a systematic literature review. Obesity. 2015;23(9):1743-1760. - PubMed
  43. Brown I, Gould J. Decisions about weight management: a synthesis of qualitative studies of obesity. Clin Obes. 2011;1(2-3):99-109. - PubMed
  44. Dewhurst A, Peters S, Devereux-Fitzgerald A, Hart J. Physicians' views and experiences of discussing weight management within routine clinical consultations: a thematic synthesis. Patient Educ Couns. 2017;100(5):897-908. - PubMed
  45. Sherson EA, Yakes Jimenez E, Katalanos N. A review of the use of the 5 A's model for weight loss counselling: differences between physician practice and patient demand. Fam Pract. 2014;31(4):389-398. - PubMed
  46. Moredich CA, Kessler TA. Physical activity and nutritional weight loss interventions in obese, low-income women: an integrative review. J Midwifery Womens Health. 2014;59(4):380-387. - PubMed
  47. Gargon E, Gorst SL, Williamson PR. Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research. PLoS ONE. 2019;14(12):e0225980. - PubMed
  48. 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. - PubMed
  49. Reddel HK, Taylor DR, Bateman ED, et al. 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. - PubMed
  50. Busse WW, Morgan WJ, Taggart V, Togias A. Asthma outcomes workshop: overview. J Allergy Clin Immunol. 2012;129(3 suppl):S1-S8. - PubMed
  51. Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-STAndardsfor reporting: the COS-STAR statement. PLoS Med. 2016;13(10):e1002148. - PubMed
  52. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132. - PubMed
  53. Mackenzie RM, Ells LJ, Simpson SA, Logue J. Core outcome set for behavioural weight management interventions for adults with overweight and obesity: standardised reporting of lifestyle weight management interventions to aid evaluation (STAR-LITE). Obes Rev. 2020;21(2):e12961. - PubMed
  54. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2008;32(4):1008-1015. - PubMed
  55. McKenna HP. The Delphi technique: a worthwhile research approach for nursing? J Adv Nurs. 1994;19(6):1221-1225. - PubMed

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