The research status and progress of core outcome sets based on COMET database_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , CHEN Shiqi ¹ , HAN Songjie ¹ , HE Tianmai ¹ , HUANG Ya ¹ , LI Min ¹ , HU Jiayuan ¹ , SUN Yang ¹ ,  CHEN Jing ² ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
2. Baokang Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding author：

CHEN Jing, Email: cjshcsyc@126.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Core outcome sets; Research progress

DOI：

10.7507/1672-2531.201804022

Video：

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Core outcome set (COS) is an agreed and minimal set of outcomes that should be measured and reported in all clinical trials in specific areas of health or healthcare, which can reduce the heterogeneity of outcomes in similar clinical trials, so that much more trials can merge in systematic reviews. Meanwhile, using COS may be easy to identify potential selective reporting bias in clinical trials. The research of COS has been developed for more than 30 years in western countries. At present there are much more researchers focusing on this area in China. However the status and progress of COS remain unclear. This paper reviewed the quantity of COS, the disease distributions of COS, the geographical locations involved in the development of COS, as well as the methodological progress of COS, so as to clarify the general situation of COS.

Citation： QIU Ruijin, CHEN Shiqi, HAN Songjie, HE Tianmai, HUANG Ya, LI Min, HU Jiayuan, SUN Yang, CHEN Jing, SHANG Hongcai. The research status and progress of core outcome sets based on COMET database. Chinese Journal of Evidence-Based Medicine, 2019, 19(5): 622-630. doi: 10.7507/1672-2531.201804022 Copy

1.	Available at: http://www.comet-initiative.org/.
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1. Available at: http://www.comet-initiative.org/.
2. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer, 1981, 47(1): 207-214.
3. Tugwell P, Boers M. OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction. J Rheumatol, 1993, 20(3): 528-530.
4. Tugwell P, Boers M, Brooks P, et al. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials, 2007, 8: 38.
5. Kirkham JJ, Clarke M, Williamson PR. A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis. BMJ, 2017, 357: j2262.
6. Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
7. Hutton JL, Williamson PR. Bias in meta-analysis due to outcome variable selection within studies. J R Stat Soc, 2000, 49(3): 359-370.
8. Blackwood B, Marshall J, Rose L. Progress on core outcome sets for critical care research. Curr Opin Crit Care, 2015, 21(5): 439-444.
9. Gargon E, Williamson PR, Altman DG, et al. The COMET Initiative database: progress and activities update (2015). Trials, 2017, 18(1): 54.
10. Maclennan S, Williamson PR, Bekema H, et al. A core outcome set for localised prostate cancer effectiveness trials. BJU Int, 2017, 120(5B): E64-E79.
11. van den Bos W, Muller BG, Ahmed H, et al. Focal therapy in prostate cancer: international multidisciplinary consensus on trial design. Eur Urol, 2014, 65(6): 1078-1083.
12. vanden Bos W, Muller BG, de Bruin DM, et al. Salvage ablative therapy in prostate cancer: international multidisciplinary consensus on trial design. Urol Oncol, 2015, 33(11): 491-495.
13. Morgans AK, van Bommel AC, Stowell C, et al. Development of a standardized set of patient-centered outcomes for advanced prostate cancer: an international effort for a unified approach. Eur Urol, 2015, 68(5): 891-898.
14. Chen RC, Chang P, Vetter RJ, et al. Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials. J Natl Cancer Inst, 2014, 106(7): dju506.
15. Harris Y, Gilman B, Ward MM, et al. Building the evidence base for tele-emergency care: efforts to identify a standardized set of outcome measures. Telemed J E Health, 2017, 23(7): 561-566.
16. van Brussel M, van der Net J, Hulzebos E, et al. The Utrecht approach to exercise in chronic childhood conditions: the decade in review. Pediatr Phys Ther, 2011, 23(1): 2-14.
17. Micke O, Seegenschmiedt MH, German Working Group on Radiotherapy in Germany. Consensus guidelines for radiation therapy of benign diseases: a multicenter approach in Germany. Int J Radiat Oncol Biol Phys, 2002, 52(2): 496-513.
18. Angus DC, Carlet J. Surviving intensive care: a report from the 2002 Brussels Roundtable. Intensive Care Med, 2003, 29(3): 68-377.
19. Fair C, Cuttance J, Sharma N, et al. International and interdisciplinary identification of health care transition outcomes. JAMA Pediatr, 2016, 170(3): 205-211.
20. Cooper NAM, Rivas C, Manchanda R, et al. Development of a core outcomes set to standardise reporting in endometrial cancer. Available at: http://www.comet-initiative.org/studies/details/986.
21. Cooper NAM, Rivas C, Manchanda R, et al. Development of a core outcomes set to standardise reporting for fertility sparing treatment of endometrial cancer and endometrial hyperplasia. Available at: http://www.comet-initiative.org/studies/details/984.
22. Smith P, Coomarasamy A, Clark J, et al. Core outcome measures for surgical management of miscarriage. Available at: http://www.comet-initiative.org/studies/details/679.
23. Smith P, Coomarasamy A, Khan K. Core outcome measures for prevention of miscarriage trials. Available at: http://www.comet-initiative.org/studies/details/815.
24. Collaborators. G D A I. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the global burden of disease Study 2016. Lancet, 2017, 390(10100): 1211-1259.
25. Ioannidis JP, Greenland S, Hlatky MA, et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet, 2014, 383(9912): 166-175.
26. Schwendicke F, Innes N. Outcomes in Trials for Management of Caries Lesions (OuTMaC). Available at: http://www.comet-initiative.org/studies/details/694.
27. Pitts NB, Stamm JW. International Consensus Workshop on Caries Clinical Trials (ICW-CCT)--final consensus statements: agreeing where the evidence leads. J Dent Res, 2004, 83 Spec No C: C125-C128.
28. Dyson MP, Shave K, Gates A, et al. Which outcomes are important to patients and families who have experienced paediatric acute respiratory illness? Findings from a mixed methods sequential exploratory study. BMJ Open, 2017, 7(12): e18199.
29. Schoenen J. Guidelines for trials of drug treatments in tension-type headache. First edition: International Headache Society Committee on Clinical Trials. Cephalalgia, 1995, 15(3): 165-179.
30. Penzien DB, Andrasik F, Freidenberg B M, et al. Guidelines for trials of behavioral treatments for recurrent headache, first edition: American headache society behavioral clinical trials workgroup. headache, 2005, 45(Suppl 2): S110-S132.
31. Penzien DB. Guidelines for trials of behavioral treatments for recurrent headache: purpose, process, and product. Headache, 2005, 45(Suppl 2): S87-S89.
32. Bendtsen L, Bigal ME, Cerbo R, et al. Guidelines for controlled trials of drugs in tension-type headache: second edition. Cephalalgia, 2010, 30(1): 1-16.
33. Andrasik F, Lipchik GL, Mccrory DC, et al. Outcome measurement in behavioral headache research: headache parameters and psychosocial outcomes. Headache, 2005, 45(5): 429-437.
34. Haywood K. Towards a core outcome set for clinical trials in headache (COSH): an international, multi-perspective Towards a core outcome set for clinical trials in headache (COSH): an international, multi-perspective initiative. Available at: http://www.comet-initiative.org/studies/details/953.
35. Karas J, Ashkenazi S, Guarino A, et al. Developing a core outcome measurement set for clinical trials in acute diarrhoea. Acta Paediatr, 2016, 105(4): e176-e180.
36. Heffernan E, Ferguson M, Hall D, et al. Development of a core outcome set for adults with mild-severe sensorineural hearing loss. Available at: http://www.comet-initiative.org/studies/details/996.
37. Malinowski AK, Shehata N, Souza RD, et al. Constructing a core outcome set for Iron Deficiency and Iron Deficiency Anaemia in Pregnancy and Postpartum. Available at: http://www.comet-initiative.org/studies/details/836.
38. Pitts NB, Stamm JW. International Consensus Workshop on Caries Clinical Trials (ICW-CCT)--final consensus statements: agreeing where the evidence leads. J Dent Res, 2004, 83 Spec No C: C125-C128.
39. Migraine I HSC. Guidelines for controlled trials of drugs in migraine. First edition. International Headache Society Committee on Clinical Trials in Migraine. Cephalalgia, 1991, 11(1): 1-12.
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