临床康复干预研究的常见问题及质量控制
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摘要
基于本团队干预研究实践并结合文献,临床干预研究主要在临床试验注册、干预方案构建、研究对象招募和依从性、干预保真度、结局指标的选择与数据采集分析等方面存在问题。应充分认识临床试验注册必要性,并遵循注册程序,以理论框架为基础规范化构建干预方案,关注阻碍及促进干预对象招募的因素以保证样本量,制订提高干预对象依从性及干预保真度的策略,根据研究内容选择恰当的结局指标、适宜的数据收集和分析方法,以保证研究质量。
Based on the experience of our team combined with literature analysis, there were some problems in study of clinical in-tervention, mainly in the aspects of clinical trial registration, construction of intervention programs, recruitment and com-pliance of research objects, intervention fidelity, selection of outcome indicators and data collection and analysis. It is necessary to understand the importance of clinical trial registration and follow the registration procedure, establish an in-tervention program based on the theoretical framework, focus on the factors that impede or promote the recruitment of objects to ensure the sample size, formulate strategies to improve the compliance and intervention fidelity of the inter-vention objects and select the appropriate outcome indicators,apply appropriate data collection and analysis methods based on the content of the study, and thus improve the quality of intervention researches.
Based on the experience of our team combined with literature analysis, there were some problems in study of clinical in-tervention, mainly in the aspects of clinical trial registration, construction of intervention programs, recruitment and com-pliance of research objects, intervention fidelity, selection of outcome indicators and data collection and analysis. It is necessary to understand the importance of clinical trial registration and follow the registration procedure, establish an in-tervention program based on the theoretical framework, focus on the factors that impede or promote the recruitment of objects to ensure the sample size, formulate strategies to improve the compliance and intervention fidelity of the inter-vention objects and select the appropriate outcome indicators,apply appropriate data collection and analysis methods based on the content of the study, and thus improve the quality of intervention researches.
引文
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[3]Laba J M,Senan S,Schellenberg D,et al.Identifying barriers to accru-al in radiation oncology randomized trials[J].Curr Oncol,2017,24(6):e524-e530.
[4]吴泰相,李幼平,李静,等.中国临床试验注册和发表机制及实施说明[J].中国康复理论与实践,2006,12(9):778-779.
[5]Gray R,Badnapurkar A,Hassanein E,et al.Registration of randomized controlled trials in nursing journals[J].Res Integr Peer Rev,2017,2(1):8.
[6]杜亮,李幼平,张永刚.强化两端,健全高质量证据生产的全程质控[J].中国循证医学杂志,2017,17(11):1241-1244.
[7]Viergever R F,Li K.Trends in global clinical trial registration:an anal-ysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013[J].BMJ Open,2015,5(9):e008932.
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[11]Yamato T,Maher C,Saragiotto B,et al.Improving completeness and transparency of reporting in clinical trials using the template for inter-vention description and replication(TIDieR)checklist will benefit the physiotherapy profession[J].J Man Manip Ther,2016,24(4):183-184.
[12]Bacon S L,Lavoie K L,Ninot G,et al.An international perspective on improving the quality and potential of behavioral clinical trials[J].Curr Cardiovascul Risk Rep,2015,9(1):1-6.
[13]Chan A W,Tetzlaff J M,Altman D G,et al.SPIRIT 2013 Statement:Defining Standard Protocol Items for Clinical Trials[J].Ann Intern Med,2013,158(3):200-207.
[14]Schulz K F,Altman D G,Moher D.CONSORT 2010 Statement:up-dated guidelines for reporting parallel group randomised trials[J].Int JSurg,2011,9(8):672-677.
[15]Daykin A,Clement C,Gamble C,et al.'Recruitment,recruitment,re-cruitment'-the need for more focus on retention:a qualitative study of five trials[J].Trials,2018,19(1):76.
[16]Fletcher B,Gheorghe A,Moore D,et al.Improving the recruitment activity of clinicians in randomised controlled trials:a systematic re-view[J].BMJ Open,2012,2(1):e000496.
[17]Spaar A,Frey M,Turk A,et al.Recruitment barriers in a randomized controlled trial from the physicians'perspective-a postal survey[J].BMC Med Res Methodol,2009,9(1):14.
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[19]Briel M,Olu K K,Von E E,et al.A systematic review of discontin-ued trials suggested that most reasons for recruitment failure were pre-ventable[J].J Clin Epidemiol,2016,80:8-15.
[20]Alba R,Ann A,Peter W,et al.A new simple six-step model to pro-mote recruitment to RCTs was developed and successfully implement-ed[J].J Clin Epidemiol,2016,76:166-174.
[21]Mills N,Blazeby J M,Hamdy F C,et al.Training recruiters to ran-domized trials to facilitate recruitment and informed consent by explor-ing patients'treatment preferences[J].Trials,2014,15(1):323.
[22]Wilson C,Rooshenas L,Paramasivan S,et al.Development of a framework to improve the process of recruitment to randomised con-trolled trials(RCTs):the SEAR(Screened,Eligible,Approached,Ran-domised)framework[J].Trials,2018,19(1):50.
[23]Ailish H,Mary O,Byrne M C,et al.Identifying strategies to maxi-mise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care[J].BMC Med Res Methodol,2009,9(1):40.
[24]Mars T,Ellard D,Carnes D,et al.Fidelity in complex behavior change interventions:a standardised approach to evaluate intervention integrity[J].BMJ Open,2013,3(11):e003555.
[25]Bellg A J,Borrelli B,Resnick B,et al.Enhancing treatment fidelity in health behavior change studies:best practices and recommendations from the NIH Behavior Change Consortium[J].Health Psychol,2004,23(5):443-451.
[26]Spillane V,Byrne M C,Byrne M,et al.Monitoring treatment fidelity in a randomized controlled trial of a complex intervention[J].J Adv Nurs,2007,60(3):343-352.
[27]Morgan P P.Compliance in health care[J].Can Med Assoc J,1979,121(11):1495.
[28]El Feky A,Gillies K,Gardner H,et al.A protocol for a systematic re-view of non-randomised evaluations of strategies to increase participant retention to randomised controlled trials[J].Syst Rev,2018,7(1):30.
[29]Brueton V C,Tierney J F,Stenning S,et al.Strategies to improve re-tention in randomised trials:a Cochrane systematic review and metaanalysis[J].BMJ Open,2014,4(2):e003821.
[30]Booker C L,Harding S,Benzeval M.A systematic review of the ef-fect of retention methods in population-based cohort studies[J].BMCPublic Health,2011,11(1):1-12.
[31]Abshire M,Dinglas V D,Cajita M I A,et al.Participant retention practices in longitudinal clinical research studies with high retention rates[J].BMC Med Res Methodol,2017,17(1):30.
[32]Donabedian A.The quality of care.How can it be assessed?1988[J].Arch Pathol Lab Med,1997,121(11):1145-1150.
[33]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[J].中国循证医学杂志,2018,18(2):238-243.
[34]赵玉婷.临床试验数据管理常见问题类型分析方法的建立[D].上海:复旦大学,2012.
[35]Hussain J A,White I R,Langan D,et al.Missing data in randomised controlled trials testing palliative interventions pose a significant risk of bias and loss of power:a systematic review and meta-analyses[J].JClin Epidemiol,2015,74:57-65.
[2]吴蓉,董冰媛,刘一洋.医学论文文稿撰写中的质量问题及改进意见[J].实用医药杂志,2017,34(7):664-666.
[3]Laba J M,Senan S,Schellenberg D,et al.Identifying barriers to accru-al in radiation oncology randomized trials[J].Curr Oncol,2017,24(6):e524-e530.
[4]吴泰相,李幼平,李静,等.中国临床试验注册和发表机制及实施说明[J].中国康复理论与实践,2006,12(9):778-779.
[5]Gray R,Badnapurkar A,Hassanein E,et al.Registration of randomized controlled trials in nursing journals[J].Res Integr Peer Rev,2017,2(1):8.
[6]杜亮,李幼平,张永刚.强化两端,健全高质量证据生产的全程质控[J].中国循证医学杂志,2017,17(11):1241-1244.
[7]Viergever R F,Li K.Trends in global clinical trial registration:an anal-ysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013[J].BMJ Open,2015,5(9):e008932.
[8]邬兰,田国祥,王行环,等.临床试验的注册及注册平台比较分析[J].中国循证心血管医学杂志,2017,9(2):129-134.
[9]耿朝辉,袁长蓉.构建移动医疗领域健康行为干预模式的常用理论框架[J].解放军护理杂志,2016,33(3):43-48.
[10]Lewis F M,张娜芹,刘均娥,等.设计以证据为基础的干预:从描述性研究到临床实验研究[J].中国护理管理,2016,16(8):1013-1017.
[11]Yamato T,Maher C,Saragiotto B,et al.Improving completeness and transparency of reporting in clinical trials using the template for inter-vention description and replication(TIDieR)checklist will benefit the physiotherapy profession[J].J Man Manip Ther,2016,24(4):183-184.
[12]Bacon S L,Lavoie K L,Ninot G,et al.An international perspective on improving the quality and potential of behavioral clinical trials[J].Curr Cardiovascul Risk Rep,2015,9(1):1-6.
[13]Chan A W,Tetzlaff J M,Altman D G,et al.SPIRIT 2013 Statement:Defining Standard Protocol Items for Clinical Trials[J].Ann Intern Med,2013,158(3):200-207.
[14]Schulz K F,Altman D G,Moher D.CONSORT 2010 Statement:up-dated guidelines for reporting parallel group randomised trials[J].Int JSurg,2011,9(8):672-677.
[15]Daykin A,Clement C,Gamble C,et al.'Recruitment,recruitment,re-cruitment'-the need for more focus on retention:a qualitative study of five trials[J].Trials,2018,19(1):76.
[16]Fletcher B,Gheorghe A,Moore D,et al.Improving the recruitment activity of clinicians in randomised controlled trials:a systematic re-view[J].BMJ Open,2012,2(1):e000496.
[17]Spaar A,Frey M,Turk A,et al.Recruitment barriers in a randomized controlled trial from the physicians'perspective-a postal survey[J].BMC Med Res Methodol,2009,9(1):14.
[18]Mills E J,Seely D,Rachlis B,et al.Barriers to participation in clini-cal trials of cancer:a meta-analysis and systematic review of patient-re-ported factors[J].Lancet Oncol,2006,7(2):141-148.
[19]Briel M,Olu K K,Von E E,et al.A systematic review of discontin-ued trials suggested that most reasons for recruitment failure were pre-ventable[J].J Clin Epidemiol,2016,80:8-15.
[20]Alba R,Ann A,Peter W,et al.A new simple six-step model to pro-mote recruitment to RCTs was developed and successfully implement-ed[J].J Clin Epidemiol,2016,76:166-174.
[21]Mills N,Blazeby J M,Hamdy F C,et al.Training recruiters to ran-domized trials to facilitate recruitment and informed consent by explor-ing patients'treatment preferences[J].Trials,2014,15(1):323.
[22]Wilson C,Rooshenas L,Paramasivan S,et al.Development of a framework to improve the process of recruitment to randomised con-trolled trials(RCTs):the SEAR(Screened,Eligible,Approached,Ran-domised)framework[J].Trials,2018,19(1):50.
[23]Ailish H,Mary O,Byrne M C,et al.Identifying strategies to maxi-mise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care[J].BMC Med Res Methodol,2009,9(1):40.
[24]Mars T,Ellard D,Carnes D,et al.Fidelity in complex behavior change interventions:a standardised approach to evaluate intervention integrity[J].BMJ Open,2013,3(11):e003555.
[25]Bellg A J,Borrelli B,Resnick B,et al.Enhancing treatment fidelity in health behavior change studies:best practices and recommendations from the NIH Behavior Change Consortium[J].Health Psychol,2004,23(5):443-451.
[26]Spillane V,Byrne M C,Byrne M,et al.Monitoring treatment fidelity in a randomized controlled trial of a complex intervention[J].J Adv Nurs,2007,60(3):343-352.
[27]Morgan P P.Compliance in health care[J].Can Med Assoc J,1979,121(11):1495.
[28]El Feky A,Gillies K,Gardner H,et al.A protocol for a systematic re-view of non-randomised evaluations of strategies to increase participant retention to randomised controlled trials[J].Syst Rev,2018,7(1):30.
[29]Brueton V C,Tierney J F,Stenning S,et al.Strategies to improve re-tention in randomised trials:a Cochrane systematic review and metaanalysis[J].BMJ Open,2014,4(2):e003821.
[30]Booker C L,Harding S,Benzeval M.A systematic review of the ef-fect of retention methods in population-based cohort studies[J].BMCPublic Health,2011,11(1):1-12.
[31]Abshire M,Dinglas V D,Cajita M I A,et al.Participant retention practices in longitudinal clinical research studies with high retention rates[J].BMC Med Res Methodol,2017,17(1):30.
[32]Donabedian A.The quality of care.How can it be assessed?1988[J].Arch Pathol Lab Med,1997,121(11):1145-1150.
[33]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[J].中国循证医学杂志,2018,18(2):238-243.
[34]赵玉婷.临床试验数据管理常见问题类型分析方法的建立[D].上海:复旦大学,2012.
[35]Hussain J A,White I R,Langan D,et al.Missing data in randomised controlled trials testing palliative interventions pose a significant risk of bias and loss of power:a systematic review and meta-analyses[J].JClin Epidemiol,2015,74:57-65.
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