中国循证医学杂志

中国循证医学杂志

基于 COMET 数据库的核心指标集研究现状及进展研究

查看全文

核心指标集是指同一疾病/健康领域所有临床研究应当报告的最小指标集合。使用核心指标集,可以减少同类临床研究由于结局指标选择的异质性而无法纳入系统评价的情况,同时也能更容易识别出临床研究中潜在的选择性报告偏倚。核心指标集研究在国外已有 30 余年的历史,目前国内有不少研究者开始关注该领域,但对核心指标集的研究现状及进展并不清楚。本研究通过对核心指标集研究的数量变化、疾病分布、地域分布及方法学的进展进行综述,以明确核心指标集研究的概况。

Core outcome sets (COS) are an agreed and minimum 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 easily identified potential selective reporting bias in clinical trials. The research of core outcome sets has developed for more than 30 years in foreign countries. Now there are much more researchers focusing on this area, but the status and progress of COS remain unclear. This paper reviewed the number of COS, the disease of COS, the geographical locations involved in the development of COS, as well as the methodological progress of COS, so that the overview of COS will be clear.

关键词: 核心指标集; 研究进展

Key words: Core outcome sets; research progress

登录后 ,请手动点击刷新查看全文内容。 没有账号,
登录后 ,请手动点击刷新查看图表内容。 没有账号,
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 RoyY 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 D G, 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. van den 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.
40. Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia, 2000, 20(9): 765-786.
41. Tfelt-Hansen P, Pascual J, Ramadan N, et al. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia, 2012, 32(1): 6-38.
42. Smelt AF, Louter MA, Kies DA, et al. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One, 2014, 9(6): e98933.
43. Gonzalez U, Whitton M, Eleftheriadou V, et al. Guidelines for designing and reporting clinical trials in vitiligo. Arch Dermatol, 2011, 147(12): 1428-1436.
44. Eleftheriadou V, Thomas KS, Whitton ME, et al. Which outcomes should we measure in vitiligo? Results of a systematic review and a survey among patients and clinicians on outcomes in vitiligo trials. Br J Dermatol, 2012, 67(4): 804-814.
45. Eleftheriadou V, Thomas K, van Geel N, et al. Developing core outcome set for vitiligo clinical trials: international e-Delphi consensus. Pigment Cell Melanoma Res, 2015, 28(3): 363-369.
46. Olliaro P, Vaillant M, Arana B, et al. Methodology of clinical trials aimed at assessing interventions for cutaneous leishmaniasis. PLoS Negl Trop Dis, 2013, 7(3): e2130.
47. Simpson RC, Thomas KS, Murphy R. Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials. Br J Dermatol, 2013, 169(3): 494-501.
48. Tang J, Samuelson E, Schaeffer M, et al. Core outcome set for melasma. Available at: http://www.comet-initiative.org/studies/details/752.
49. Shokeen D, Samuelson E, Schaeffer M, et al. Core outcome set for post-inflammatory hyperpigmentation (PIH). http://www.comet-initiative.org/studies/details/753.
50. Vasic J, Samuelson EP, Goldberg L, et al. Core Outcome Set for Actinic Keratosis. Available at: http://www.comet-initiative.org/studies/details/756.
51. Colavincenzo M, Schlessinger D, Iyengar S, et al. Core Outcome Set for Hair Loss/Non-Scarring Alopecia. Available at: http://www.comet-initiative.org/studies/details/759.
52. Prinsen C, van Akkooi A, Bekkenk M, et al. Developing a Core Outcome Set (COS) for melanoma trials. Available at: http://www.comet-initiative.org/studies/details/783.
53. Page RC, Derouen TA. Design issues specific to studies of periodontitis. J Periodontal Res, 1992, 27(4 Pt 2): 395-404, 412-416.
54. Imrey PB, Chilton NW, Pihlstrom BL, et al. Proposed guidelines for American Dental Association acceptance of products for professional, non-surgical treatment of adult periodontitis. Task Force on Design and Analysis in Dental and Oral Research. J Periodontal Res, 1994, 29(5): 348-360.
55. Lightfoot WS, Hefti A, Mariotti A. Using a Delphi panel to survey criteria for successful periodontal therapy in posterior teeth. J Periodontol, 2005, 76(9): 1502-1507.
56. Lightfoot WS, Hefti A, Mariotti A. Using a Delphi panel to survey criteria for successful periodontal therapy in anterior teeth. J Periodontol, 2005, 76(9): 1508-1512.
57. Glenny A, Worthington H, Walsh T, et al. Core outcome measures and selective outcome reporting in randomised controlled trials for the prevention and treatment of periodontal disease. Available at: http://www.comet-initiative.org/studies/details/265.
58. 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.
59. Barry J, Akeroyd M, Leighton P, et al. Core outcomes for research into management of otitis media with effusion in otherwise-healthy children. Available at: http://www.comet-initiative.org/studies/details/817.
60. Thiboutot D, Tan J, Layton A. Development of clinical trials outcome instruments for acne vulgaris. Available at: http://www.comet-initiative.org/studies/details/358.
61. Clark M, Samuelson E, Schaeffer M, et al. Core outcome set for acne scarring. Available at: http://www.comet-initiative.org/studies/details/754.
62. Schmitt J, Langan S, Williams HC. What are the best outcome measurements for atopic eczema? A systematic review. J Allergy Clin Immunol, 2007, 120(6): 1389-1398.
63. Schmitt J, Williams H. Harmonising Outcome Measures for Eczema (HOME). Report from the First International Consensus Meeting (HOME 1), 24 July 2010, Munich, Germany. Br J Dermatol, 2010, 163(6): 1166-1168.
64. Schmitt J, Langan S, Stamm T, et al. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Invest Dermatol, 2011, 131(3): 623-630.
65. Schmitt J, Spuls P, Boers M, et al. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting. Allergy, 2012, 67(9): 1111-1117.
66. Bussche K V D, Kottner J, Beele H, et al. Core outcome domains in incontinence-associated dermatitis research. http://www.comet-initiative.org/studies/details/383.[2018-3-15].
67. Deyo RA, Battie M, Beurskens AJ, et al. Outcome measures for low back pain research. A proposal for standardized use. Spine (Phila Pa 1976), 1998, 23(18): 2003-2013.
68. Devogelaer JP, Dreiser RL, Abadie E, et al. Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain. Clin Exp Rheumatol, 2003, 21(6): 691-694.
69. Chiarotto A, Deyo RA, Terwee CB, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J, 2015, 24(6): 1127-1142.
70. Devane D, Duane S, Vellinga A, et al. The development of a core outcome set for interventions in the treatment of uncomplicated urinary tract infections (UTI’s) in adult patients. Available at: http://www.comet-initiative.org/studies/details/950.
71. Powers JH. Recommendations for improving the design, conduct, and analysis of clinical trials in hospital-acquired pneumonia and ventilator-associated pneumonia. Clin Infect Dis, 2010, 51(Suppl 1): S18-S28.
72. Barlow GD, Lamping DL, Davey PG, et al. Evaluation of outcomes in community-acquired pneumonia: a guide for patients, physicians, and policy-makers. Lancet Infect Dis, 2003, 3(8): 476-488.
73. Lamb SE, Jorstad-Stein E C, Hauer K, et al. Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus. J Am Geriatr Soc, 2005, 53(9): 1618-1622.
74. Sibley KM, Howe T, Lamb SE, et al. Recommendations for a core outcome set for measuring standing balance in adult populations: a consensus-based approach. PLoS One, 2015, 10(3): e120568.
75. Sun Y, He L, Fan J. Core outcome sets of integrity of modern and traditional Chinese medicine on treatment of chronic Hepatitis B. Available at: http://www.comet-initiative.org/studies/details/669.
76. Cochrane Hepato-Biliary Group. Core outcomes for Cochrane reviews of chronic hepatitis B and C virus infections. http://www.comet-initiative.org/studies/details/813.
77. Offringa M, Butcher N, Monsour A, et al. Core set of outcomes for adolescents with major depressive disorder: A tool of standardized outcomes for clinical research and practice. Available at: http://www.comet-initiative.org/studies/details/1122.
78. Glenny A, Worthington H, Walsh T, et al. Core outcome measures and selective outcome reporting in randomised controlled trials for the prevention and treatment of periodontal disease. Available at: http://www.comet-initiative.org/studies/details/265.
79. Davis K, Gorst SL, Harman N, et al. Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries. PLoS One, 2018, 13(2): e190695.
80. Biggane AM, Brading L, Ravaud P, et al. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials, 2018, 19(1): 113.
81. Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med, 2016, 13(10): e1002148.
82. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials, 2016, 17(1): 449.
83. Kirkham JJ, Davis K, Altman DG, et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
84. Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
85. Zhang L, Zhang J, Chen J, et al. Clinical research of traditional chinese medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
86. Zhang J, Xing D, Shang H. Developing a core outcome set for traditional Chinese medicine for stable angina pectoris. Available at: http://www.comet-initiative.org/studies/details/391.
87. 邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
88. 张冬, 张明妍, 郑文科, 等. 中医药临床试验核心指标集构建及德尔菲法实施规范. 中医杂志, 2017, 58(1): 20-22.
89. 邱瑞瑾, 张晓雨, 李敏, 等. 中医证候命名规范化研究在核心指标集构建中的意义及方法. 中华中医药杂志, 2018, 33(6): 2240-2243.
90. 邱瑞瑾, 陈静, 雷翔, 等. 引入核心指标集概念构建中医临床疗效模糊综合评价方法. 中药新药与临床药理, 2018, 29(4): 528-534.
91. 张明妍, 杨丰文, 李越, 等. 核心指标集报告规范: COS-STAR 声明. 中国循证医学杂志, 2017, 17(4): 470-474.
92. 邱瑞瑾, 李敏, 韩松洁, 等. 《COMET 手册》1.0 版解读及其对构建中医临床研究核心指标集的启示. 中国循证医学杂志, 2017, 17(12): 1482-1488.
93. 邱瑞瑾, 孙杨, 胡嘉元, 等. 临床研究中选择结局指标测量工具的方法. 中国循证医学杂志, 2018, 18(2): 238-243.
94. 张明妍, 张俊华, 杜亮, 等. 译文: 核心指标集研制标准: COS-STAD 推荐. 中国循证医学杂志, 2018, 18(7): 753-757.
95. Qiu R, Li M, Zhang X, et al. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials, 2018, 19(1): 541.
96. McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc, 2015, 4(5): e001767.