社会和心理学干预随机对照试验的报告规范(2018)解读
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摘要
<正>随机对照试验(RCT)因其消除偏倚、平衡混杂因素、提高统计学检验的有效性等优点,被公认为是评价干预措施效果的金标准[1],逐渐推广到临床以外的社会和心理学研究领域。社会和心理学干预(SPI)旨在改善身体、心理健康和社会结局,相比临床干预类型复杂多样,并且干预间存在相互作用,结局指标也涉及多个层次(如个人、家庭和社区等)[2]。目前,对于SPI的RCT报告仍然采用RCT报告
引文
[1]Byar DP,Simon RM,Friedewald WT,et al. Randomized clinical trials. Perspectives on some recent ideas. N Engl J Med,1976,295(2):74-80
[2]Watson MC. A Framework for Development and Evaluation of RCT’s for Complex Interventions to Improve Health. Int J Pharm Pract,2000,14(4):233-234
[3]Schulz KF,Altman DG,Moher D,et al. CONSORT 2010Statement:updated guidelines for reporting parallel group randomised trials. BMJ,2010,340:c332
[4]Stinson JN,Mc Grath PJ,Yamada JT. Clinical trials in the Journal of Pediatric Psychology:applying the CONSORT Statement. J Pediatr Psychol,2003,28:159-167
[5]Bonell C,Oakley A,Hargreaves J,et al. Assessment of generalisability in trials of health interventions:suggested framework and systematic review. BMJ,2006,333(7563):346-349
[6]Grant SP,Mayo-Wilson E,Melendez-Torres GJ,et al.Reporting quality of social and psychological intervention trials:a systematic review of reporting guidelines and trial publications. PLoS One,2013,8(5):e65442
[7]Grant S,Mayo-Wilson E,Montgomery P,et al. CONSORTSPI 2018 Explanation and Elaboration:guidance for reporting social and psychological intervention trials. Trials,2018,19(1):406
[8]Grant SP,Mayo-Wilson E,Melendez-Torres GJ,et al.Reporting quality of social and psychological intervention trials:a systematic review of reporting guidelines and trial publications. PLoS One,2013,8(5):e65442
[9]杜亮,刁骧.更好地报告随机试验中的危害:CONSORT声明扩展版.中国循证医学杂志,2006,6(9):682-689
[10]詹思延.第二讲:如何报告随机对照试验———国际报告规范CONSORT及其扩展版解读.中国循证儿科杂志,2010,5(2):146-150
[11]Campbell MK,Piaggio G,Elbourne DR,et al. CONSORT2010 statement:extension to cluster randomised trials. BMJ,2012,345:e5661
[12]Gagnier JJ,Boon H,Rochon P,et al. Reporting Randomized,Controlled Trials of Herbal Interventions:An Elaborated CONSORT Statement. Ann Intern Med,2006,144(5):364-367
[13]Hopewell S,Clarke M,Moher D,et al. CONSORT for reporting randomised trials in journal and conference abstracts.Lancet,2008,371(9609):281-283
[14]Mac Pherson H,Altman DG,Hammerschlag R,et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA):extending the CONSORT statement.PLoS Med,2010,7(6):e1000261
[15]Cheng CW,Wu TX,Shang HC,et al. CONSORT Extension for Chinese Herbal Medicine Formulas 2017:Recommendations,Explanation,and Elaboration. Ann Intern Med,2017,167(2):112-121
[2]Watson MC. A Framework for Development and Evaluation of RCT’s for Complex Interventions to Improve Health. Int J Pharm Pract,2000,14(4):233-234
[3]Schulz KF,Altman DG,Moher D,et al. CONSORT 2010Statement:updated guidelines for reporting parallel group randomised trials. BMJ,2010,340:c332
[4]Stinson JN,Mc Grath PJ,Yamada JT. Clinical trials in the Journal of Pediatric Psychology:applying the CONSORT Statement. J Pediatr Psychol,2003,28:159-167
[5]Bonell C,Oakley A,Hargreaves J,et al. Assessment of generalisability in trials of health interventions:suggested framework and systematic review. BMJ,2006,333(7563):346-349
[6]Grant SP,Mayo-Wilson E,Melendez-Torres GJ,et al.Reporting quality of social and psychological intervention trials:a systematic review of reporting guidelines and trial publications. PLoS One,2013,8(5):e65442
[7]Grant S,Mayo-Wilson E,Montgomery P,et al. CONSORTSPI 2018 Explanation and Elaboration:guidance for reporting social and psychological intervention trials. Trials,2018,19(1):406
[8]Grant SP,Mayo-Wilson E,Melendez-Torres GJ,et al.Reporting quality of social and psychological intervention trials:a systematic review of reporting guidelines and trial publications. PLoS One,2013,8(5):e65442
[9]杜亮,刁骧.更好地报告随机试验中的危害:CONSORT声明扩展版.中国循证医学杂志,2006,6(9):682-689
[10]詹思延.第二讲:如何报告随机对照试验———国际报告规范CONSORT及其扩展版解读.中国循证儿科杂志,2010,5(2):146-150
[11]Campbell MK,Piaggio G,Elbourne DR,et al. CONSORT2010 statement:extension to cluster randomised trials. BMJ,2012,345:e5661
[12]Gagnier JJ,Boon H,Rochon P,et al. Reporting Randomized,Controlled Trials of Herbal Interventions:An Elaborated CONSORT Statement. Ann Intern Med,2006,144(5):364-367
[13]Hopewell S,Clarke M,Moher D,et al. CONSORT for reporting randomised trials in journal and conference abstracts.Lancet,2008,371(9609):281-283
[14]Mac Pherson H,Altman DG,Hammerschlag R,et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA):extending the CONSORT statement.PLoS Med,2010,7(6):e1000261
[15]Cheng CW,Wu TX,Shang HC,et al. CONSORT Extension for Chinese Herbal Medicine Formulas 2017:Recommendations,Explanation,and Elaboration. Ann Intern Med,2017,167(2):112-121