A Core Outcome Set for the Benefits and Adverse Events of Bariatric and Metabolic Surgery: The BARIACT Project

English version České info

Karen Coulman and colleagues present a core outcome set developed by patients and health professionals for BARIAtric and metabolic surgery Clinical Trials (BARIACT).

Vyšlo v časopise: A Core Outcome Set for the Benefits and Adverse Events of Bariatric and Metabolic Surgery: The BARIACT Project. PLoS Med 13(11): e32767. doi:10.1371/journal.pmed.1002187
Kategorie: Guidelines and Guidance
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002187

Souhrn

Karen Coulman and colleagues present a core outcome set developed by patients and health professionals for BARIAtric and metabolic surgery Clinical Trials (BARIACT).

Zdroje

1. World Health Organisation. Obesity and overweight. 2016. http://www.who.int/mediacentre/factsheets/fs311/en/.

2. Dietz WH, Baur LA, Hall K, Puhl RM, Taveras EM, Uauy R, et al. Management of obesity: improvement of health-care training and systems for prevention and care. Lancet 2015; 385(9986): 2521–33. doi: 10.1016/S0140-6736(14)61748-7 25703112

3. Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev 2014 Aug; (8):CD003641.

4. National Institute for Health and Care Excellence [Internet]. Obesity: identification, assessment and management of overweight and obesity in children, young people and adults. London, 2014 [cited 11.4.2016]. https://www.nice.org.uk/guidance/cg189.

5. Angrisani L, Santonicola A, Iovino P, Formisano G, Buchwald H, Scopinaro N. Bariatric Surgery Worldwide 2013. Obes Surg 2015; 25(10): 1822–32. doi: 10.1007/s11695-015-1657-z 25835983

6. Buwen JP, Kammerer MR, Beekley AC, Tichansky DS. Laparoscopic sleeve gastrectomy: The rightful gold standard weight loss surgery procedure. Surg Obes Relat Dis 2015; 11(6): 1383–5. doi: 10.1016/j.soard.2015.06.013 26278194

7. O'Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg 2013; 257(1): 87–94. doi: 10.1097/SLA.0b013e31827b6c02 23235396

8. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials 2012; 13: 132. doi: 10.1186/1745-6215-13-132 22867278

9. 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 22294719

10. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A- W, Cronin E, et al. Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias. PLoS ONE 2008; 3(8): e3081. doi: 10.1371/journal.pone.0003081 18769481

11. Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews?—a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials 2013; 14: 21. doi: 10.1186/1745-6215-14-21 23339751

12. Coulman K, Owen-Smith A, Blazeby J, Welbourn R, Andrews R. The patient perspective of living with surgery for morbid obesity: Creating a patient 'core' outcome set, and investigating ways to improve follow-up care [Internet]. 2012 [cited 6.10.2016]. http://www.comet-initiative.org/studies/details/169?result=true.

13. Hopkins J, Blazeby J. Development of a core outcome set for bariatric surgery [Internet]. 2011 [cited 6.10.2016]. http://www.comet-initiative.org/studies/details/131?result=true.

14. Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al. (2016) Core Outcome Set–STAndards for Reporting: The COS-STAR Statement. PLoS Med 13(10): e1002148. doi: 10.1371/journal.pmed.1002148 27755541

15. Hopkins JC, Howes N, Chalmers K, Savovic J, Whale K, Coulman 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. doi: 10.1111/obr.12240 25442513

16. 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): 707–20. doi: 10.1111/obr.12041 23639053

17. Coulman KD, Owen-Smith A, Andrews RC, Chalmers K, Ferguson Y, Norton S, et al. The Patient Perspective of Bariatric Surgery Outcomes: Developing a 'Core' Set of Patient-Reported Outcomes. Obes Surg 2014; 24(8): 1296.

18. Coulman K, Owen-Smith A, Andrews R, Norton S, Welbourn R, Blazeby J. The patient perspective of outcomes of bariatric surgery: The need for a 'core' set of patient-reported outcomes. Br J Surg 2013; 100(S3): 2–3.

19. Macefield RC, Jacobs M, Korfage IJ, Nicklin J, Whistance RN, Brookes ST, et al. Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials 2014; 15: 49. doi: 10.1186/1745-6215-15-49 24495582

20. Coulman K, Howes N, Hopkins J, Whale K, Chalmers K, Brookes S, et al. A comparison of health professionals' and patients' views of the importance of the outcomes of bariatric surgery. Obes Surg 2016; May 2 [epub ahead of print].

21. Blazeby J, Andrews R, Byrne J, Donovan J, Reeves B, Roderick P, et al. HTA—09/127/53: Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial (The By-Band-Sleeve study) [Internet]. 2012 [cited 11.4.2016]. http://www.nets.nihr.ac.uk/projects/hta/0912753.

22. 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 21283604

23. Blazeby JM, Macefield R, Blencowe NS, Jacobs M, McNair AG, Sprangers M, et al. Core information set for oesophageal cancer surgery. Br J Surg 2015; 102(8): 936–43. doi: 10.1002/bjs.9840 25980524

24. TurningPoint 5. Turning Technologies, LLC [software]. 2013.

25. Stata/MP 13.1. College Station, Texas: StataCorp LP [software]. 2013.

26. Stucki A, Daansen P, Fuessl M, Cieza A, Huber E, Atkinson R, et al. ICF Core Sets for obesity. J Rehabil Med 2004 Jul; (44 Suppl): 107–13. doi: 10.1080/16501960410016064 15370757

27. 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 Jul; (44 Suppl): 12–21. doi: 10.1080/16501960410015443 15370743

28. Wolff B, Cieza A, Parentin A, Rauch A, Sigl T, Brockow T, et al. Identifying the concepts contained in outcome measures of clinical trials on four internal disorders using the International Classification of Functioning, Disability and Health as a reference. J Rehabil Med 2004 Jul; (44 Suppl): 37–42. doi: 10.1080/16501960410015407 15370746

29. Ewert T, Fuessl M, Cieza A, Andersen C, Chatterji S, Kostanjsek N, et al. Identification of the most common patient problems in patients with chronic conditions using the ICF checklist. J Rehabil Med 2004 Jul; (44 Suppl): 22–9. doi: 10.1080/16501960410015362 15370744

30. Main BG, Blencowe N, Williamson PR, Blazeby JM. RE: Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst 2015; 107(4): dju506.

31. Meana M, Ricciardi L. Obesity surgery: Stories of altered lives. Reno: University of Nevada Press; 2008.

32. Boers M, Kirwan JR, Wells J, Beaton D, Gossec L, d'Agostino MA, et al. Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0. J Clin Epidemiol 2014; 67(7): 745–53. doi: 10.1016/j.jclinepi.2013.11.013 24582946

33. VU University Medical Center. COnsensus-based Standards for the selection of health Measurement INstruments [Internet]. 2016 [cited 11.4.2016]. http://www.cosmin.nl/index.html.