基于COMET数据库的核心指标集研究现状及进展
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摘要
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不同结局指标选择导致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 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.
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.
引文
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15Harris 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.
16van 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.
17Micke 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.
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21Cooper 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.
22Smith 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.
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24Collaborators.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.
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26Schwendicke F,Innes N.Outcomes in Trials for Management of Caries Lesions(OuTMaC).Available at:http://www.comet-initiative.org/studies/details/694.
27Pitts 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.
28Dyson 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.
29Schoenen 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.
30Penzien 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.
31Penzien DB.Guidelines for trials of behavioral treatments for recurrent headache:purpose,process,and product.Headache,2005,45(Suppl 2):S87-S89.
32Bendtsen 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.
33Andrasik F,Lipchik GL,Mccrory DC,et al.Outcome measurement in behavioral headache research:headache parameters and psychosocial outcomes.Headache,2005,45(5):429-437.
34Haywood 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.
35Karas 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.
36Heffernan 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.
37Malinowski 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.
38Pitts 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.
39Migraine 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.
40Tfelt-Hansen P,Block G,Dahlof C,et al.Guidelines for controlled trials of drugs in migraine:second edition.Cephalalgia,2000,20(9):765-786.
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