健康公平相关随机对照试验的报告规范(CONSORT-Equity)扩展声明与解读
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摘要
为提升不同类型的随机对照试验的报告质量,CONSORT工作组一直在不断地对CONSORT声明进行完善和修订。2017年BMJ发表了健康公平相关随机对照试验的报告规范(CONSORT-Equity),旨在改善健康公平相关随机对照试验的报告现状和提高报告质量,进而依托这类研究证据改善社会健康公平性或减少社会健康的不公平现象。为此,本文结合健康公平相关随机对照试验的实例,对CONSORT-Equity进行全方位的介绍和解读。
CONSORT Group members update the CONSORT(Consolidated Standards of Reporting Trials)statement by collecting relevant literatures to improve the reporting quality of randomised controlled trials. Recently, they have outlined CONSORT-Equity reporting standards, an extension to the CONSORT statement, which had been developed to improve the reporting of intervention effects in randomised trials where health equity is relevant. It will be helpful to improve social health equity or reduce social health inequities. This paper aims to introduce CONSORT-Equity and interprets its usage by a series of randomised trials where health equity is relevant.
CONSORT Group members update the CONSORT(Consolidated Standards of Reporting Trials)statement by collecting relevant literatures to improve the reporting quality of randomised controlled trials. Recently, they have outlined CONSORT-Equity reporting standards, an extension to the CONSORT statement, which had been developed to improve the reporting of intervention effects in randomised trials where health equity is relevant. It will be helpful to improve social health equity or reduce social health inequities. This paper aims to introduce CONSORT-Equity and interprets its usage by a series of randomised trials where health equity is relevant.
引文
1WHO. Health systems financing:the path to universal coverage.World health report 2010, Available at:http://www.who.int/whr/2010/en/.
2 O’neill J, Tabish H, Welch V, et al. Applying an equity lens to interventions:using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. J Clin Epidemiol, 2014, 67(1):56-64.
3Schulz KF, Altman DG, Moher D, et al. CONSORT 2010statement:updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340:c332.
4 Dans AM, Dans L, Oxman AD, et al. Assessing equity in clinical practice guidelines. J Clin Epidemiol, 2007, 60(6):540-546.
5Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 122(8):637-639.
6 Welch VA, Norheim OF, Jull J, et al. CONSORT-Equity 2017extension and elaboration for better reporting of health equity in randomised trials. BMJ, 2017, 359(j5085).
7Listed N. A proposal for structured reporting of randomized controlled trials. the standards of reporting trials group. JAMA,1994, 272(24):1926.
8 Listed N. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working group on recommendations for reporting of clinical Trials in the Biomedical Literature. Ann Intern Med, 1994, 121(11):894-895.
9Moher D, Schulz KF, Altman D, et al. The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore(NY), 2005, 1(1):40-45.
10 Hugh MP, Altman DG, Richard H, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA):extending the CONSORT statement. J Evid Based Med, 2015, 3(3):35-46.
11Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for chinese herbal medicine formulas 2017:recommendations,explanation, and elaboration(traditional Chinese version). Ann Intern Med, 2017, 167(2):W7-W20.
12 Marcus AC, Crane LA, Kaplan CP, et al. Improving adherence to screening follow-up among women with abnormal pap smears:results from a large clinic-based trial of three intervention strategies. Med Care, 1992, 30(3):216.
13Oliver S, Kavanagh J, Caird J, et al. Health promotion, inequalities and young people’s health. 2008,
14 唐宏亮,庞军,陆慧,等.太极拳干预社区中老年人亚健康状态的临床随机对照试验.南京体育学院学报(自然科学版), 2011,2(6):6-9.
15张玲华,王君俏,白姣姣,等.社区压力性尿失禁行为管理方案对中老年女性患者认知水平及症状的影响.护理学杂志, 2011,26(15):1-4.
16 Kaufman CE, Whitesell NR, Keane EM, et al. Effectiveness of circle of life, an HIV-preventive intervention for American Indian middle school youths:a group randomized trial in a Northern Plains tribe. Am J Public Health, 2014, 104(6):e106-112.
17常芳,王欢,刘琪林,等.人力资本视角下的信息干预与农村学生身体健康-基于随机干预试验中工具变量的应用.劳动经济研究,2017,(3):64-84.
18 高云英,韩兰唐,狄巨岚,等.抗心衰标准三联疗法联合应用美托洛尔治疗老年人慢性充血性心力衰竭.临床荟萃, 2003, 18(13):739-741.
19杨娜,马融,胡思源,等.评价抽动宁胶囊治疗小儿多发性抽动障碍脾虚痰聚证有效性和安全性的分层区组随机、双盲双模拟、三臂平行对照、多中心、Ⅲ期临床研究.中国中药杂志, 2016,41(16):3100-3106.
20Raine R, Moss SM, Wagner CV, et al. A national clusterrandomised controlled trial to examine the effect of enhanced reminders on the socioeconomic gradient in uptake in bowel cancer screening. Br J Cancer, 2016, 115(12):1479-1486.
21 Booth A R, Norman P, Goyder E, et al. Pilot study of a brief intervention based on the theory of planned behaviour and selfidentity to increase chlamydia testing among young people living in deprived areas. Br Health Psychol, 2013, 19(3):636.
22周欣,刘军翔,石蕊,等.新型低钠复合离子盐降压作用的社区人群干预研究.中华高血压杂志, 2009, 6:546-552.
23 Fors A, Gyllensten H, Swedberg K, et al. Effectiveness of personcentred care after acute coronary syndrome in relation to educational level:subgroup analysis of a two-armed randomised controlled trial. Int J Cardiol, 2016, 221(957).
24Stevens A, Shamseer L, Weinstein E, et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines:systematic review. BMJ, 2014, 348(g3804).
25 Kelly JA, Amirkhanian YA, Kabakchieva E, et al. Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma(Gypsy)men in Bulgaria:randomised controlled trial. BMJ, 2006, 333(7578):1098-1101.
26张玲,郑蓉,王琛琛,等.新疆缺碘地区重点人群口服碘油丸的随机化干预研究.中国地方病防治杂志, 2013,(5):346-347.
27 Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2):e1000217.
28WHO. Definition of an older or elderly person. Available at:http://www.who.int/healthinfo/survey/ageingdefnolder/en/.
29 国务院人口普查办公室.中国2010年人口普查资料.中国统计出版社, 2012.
2 O’neill J, Tabish H, Welch V, et al. Applying an equity lens to interventions:using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. J Clin Epidemiol, 2014, 67(1):56-64.
3Schulz KF, Altman DG, Moher D, et al. CONSORT 2010statement:updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340:c332.
4 Dans AM, Dans L, Oxman AD, et al. Assessing equity in clinical practice guidelines. J Clin Epidemiol, 2007, 60(6):540-546.
5Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 122(8):637-639.
6 Welch VA, Norheim OF, Jull J, et al. CONSORT-Equity 2017extension and elaboration for better reporting of health equity in randomised trials. BMJ, 2017, 359(j5085).
7Listed N. A proposal for structured reporting of randomized controlled trials. the standards of reporting trials group. JAMA,1994, 272(24):1926.
8 Listed N. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working group on recommendations for reporting of clinical Trials in the Biomedical Literature. Ann Intern Med, 1994, 121(11):894-895.
9Moher D, Schulz KF, Altman D, et al. The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore(NY), 2005, 1(1):40-45.
10 Hugh MP, Altman DG, Richard H, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA):extending the CONSORT statement. J Evid Based Med, 2015, 3(3):35-46.
11Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for chinese herbal medicine formulas 2017:recommendations,explanation, and elaboration(traditional Chinese version). Ann Intern Med, 2017, 167(2):W7-W20.
12 Marcus AC, Crane LA, Kaplan CP, et al. Improving adherence to screening follow-up among women with abnormal pap smears:results from a large clinic-based trial of three intervention strategies. Med Care, 1992, 30(3):216.
13Oliver S, Kavanagh J, Caird J, et al. Health promotion, inequalities and young people’s health. 2008,
14 唐宏亮,庞军,陆慧,等.太极拳干预社区中老年人亚健康状态的临床随机对照试验.南京体育学院学报(自然科学版), 2011,2(6):6-9.
15张玲华,王君俏,白姣姣,等.社区压力性尿失禁行为管理方案对中老年女性患者认知水平及症状的影响.护理学杂志, 2011,26(15):1-4.
16 Kaufman CE, Whitesell NR, Keane EM, et al. Effectiveness of circle of life, an HIV-preventive intervention for American Indian middle school youths:a group randomized trial in a Northern Plains tribe. Am J Public Health, 2014, 104(6):e106-112.
17常芳,王欢,刘琪林,等.人力资本视角下的信息干预与农村学生身体健康-基于随机干预试验中工具变量的应用.劳动经济研究,2017,(3):64-84.
18 高云英,韩兰唐,狄巨岚,等.抗心衰标准三联疗法联合应用美托洛尔治疗老年人慢性充血性心力衰竭.临床荟萃, 2003, 18(13):739-741.
19杨娜,马融,胡思源,等.评价抽动宁胶囊治疗小儿多发性抽动障碍脾虚痰聚证有效性和安全性的分层区组随机、双盲双模拟、三臂平行对照、多中心、Ⅲ期临床研究.中国中药杂志, 2016,41(16):3100-3106.
20Raine R, Moss SM, Wagner CV, et al. A national clusterrandomised controlled trial to examine the effect of enhanced reminders on the socioeconomic gradient in uptake in bowel cancer screening. Br J Cancer, 2016, 115(12):1479-1486.
21 Booth A R, Norman P, Goyder E, et al. Pilot study of a brief intervention based on the theory of planned behaviour and selfidentity to increase chlamydia testing among young people living in deprived areas. Br Health Psychol, 2013, 19(3):636.
22周欣,刘军翔,石蕊,等.新型低钠复合离子盐降压作用的社区人群干预研究.中华高血压杂志, 2009, 6:546-552.
23 Fors A, Gyllensten H, Swedberg K, et al. Effectiveness of personcentred care after acute coronary syndrome in relation to educational level:subgroup analysis of a two-armed randomised controlled trial. Int J Cardiol, 2016, 221(957).
24Stevens A, Shamseer L, Weinstein E, et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines:systematic review. BMJ, 2014, 348(g3804).
25 Kelly JA, Amirkhanian YA, Kabakchieva E, et al. Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma(Gypsy)men in Bulgaria:randomised controlled trial. BMJ, 2006, 333(7578):1098-1101.
26张玲,郑蓉,王琛琛,等.新疆缺碘地区重点人群口服碘油丸的随机化干预研究.中国地方病防治杂志, 2013,(5):346-347.
27 Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2):e1000217.
28WHO. Definition of an older or elderly person. Available at:http://www.who.int/healthinfo/survey/ageingdefnolder/en/.
29 国务院人口普查办公室.中国2010年人口普查资料.中国统计出版社, 2012.