不同招募方式对针灸临床试验中受试者的影响与思考
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摘要
受试者招募困难是所有临床试验研究中普遍存在的问题,现有的临床试验受试者招募多适用于药物临床试验。由于针灸临床试验干预措施与药物不同,具有"理、法、穴、术"的特殊性,因此制定适合于针灸临床试验的受试者招募策略很有必要。本文在分析常见临床试验招募方式及其利弊的基础上,对国内外针灸临床试验中所采用的招募方式进行了比较和分析。与药物不同,针灸属于操作性治疗手段,临床试验中更强调就近原则,可选择一种招募方式,也可以同时选择传统与现代多种招募方式相结合,以更好地提高针灸临床试验中招募的成功率及病人的依从性,为临床试验的顺利开展提供重要保障。
Recruitment difficulties are all common problems in the research of clinical trials,the existing clinical trial subjects were recruited more suitable for drug clinical trials,because of the different acupuncture intervention and drug clinical trials has"the principle,method,acupuncture point,"particularity,therefore suitable for acupuncture clinical trials of recruitment strategy is necessary. Based on the analysis of recruitment methods of common clinical trials and their advantages and disadvantages,this paper compares and analyzes the recruitment methods used in clinical trials of acupuncture at home and abroad. Belongs to the operational treatment,unlike drugs,acupuncture clinical trials more emphasis on nearby principle,can choose a way of recruiting,can also choose combining traditional and modern multiple recruitment methods,in order to better improve the acupuncture clinical trials recruiting success rate and patient compliance,and provide important guarantee for the smooth progress in clinical trials.
Recruitment difficulties are all common problems in the research of clinical trials,the existing clinical trial subjects were recruited more suitable for drug clinical trials,because of the different acupuncture intervention and drug clinical trials has"the principle,method,acupuncture point,"particularity,therefore suitable for acupuncture clinical trials of recruitment strategy is necessary. Based on the analysis of recruitment methods of common clinical trials and their advantages and disadvantages,this paper compares and analyzes the recruitment methods used in clinical trials of acupuncture at home and abroad. Belongs to the operational treatment,unlike drugs,acupuncture clinical trials more emphasis on nearby principle,can choose a way of recruiting,can also choose combining traditional and modern multiple recruitment methods,in order to better improve the acupuncture clinical trials recruiting success rate and patient compliance,and provide important guarantee for the smooth progress in clinical trials.
引文
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[14]BISHOP FL,LEWITH GT.Patients’preconceptions of acupuncture:a qualitative study exploring the decisions patients make when seeking acupuncture[J].BMC Complement Alten Med,2013(13):102.
[15]LINDE K,WITT CM,STRENG A,et al.The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain[J].Pain,2007,128(3):264-271.
[16]SHERMAN K J,HAWKES R J,ICHIKAWA L,et al.Comparing recruitment strategies in a study of acupuncture for chronic back pain[J].BMC Med Res Methodol,2009(9):69.
[2]FOY R,PARRY J,DUGGAN A,et al.How evidence based are recruitment strategies to randomized controlled trials in primary care?Experience from seven studies[J].Fam Pract,2003,20(1):83-92.
[3]KASENDA BENJAMIN,VON ELM ERIK,YOU JOHN,et al.Prevalence,characteristics,and publication of discontinued randomized trials[J].JAMA,2014,311(10):1045-51.
[4]WATSON JUDITH M,TORGERSON DAVID J.Increasing recruitment to randomized trials:a review of randomized controlled trials[J].BMC Med Res Methodol,2006,6:34.
[5]GORDON JS,AKERS L,SEVERSON HH,et al.Successful participant recruitment strategies for an online smokeless tobacco cessation program[J].Nicotine Tob Res,2006,8(Suppl 1):S35-S41.
[6]牟钰洁,韩梅,王丽琼,等.中医药临床试验受试者招募过程中的策略制定[J].中国药物评价,2013,30(5):261-264.
[7]ELAINE ES.Research ethics,informed consent,and participant recruitment[J].Clinical nurse specialist,2004,18(2):88-96.
[8]严康.临床试验中影响受试者招募的因素分析[D].南京:南京中医药大学,2015.
[9]梁繁荣,许能贵.针灸学临床研究[M].北京:人民卫生出版社,2016:113-115.
[10]李宁,王丹琳,王成伟,等.关于针灸医学临床随机对照试验研究的思考[J].中国针灸,2007,27(7):529-532.
[11]樊海龙,赵凌,李涓,等.浅谈针灸临床试验中社区义诊招募策略的制定[J].中国针灸,2016,36(4):413-416.
[12]李旭东,董成双.浅谈微信公众号的推广及传播[J].新闻研究导刊,2015,6(17):247.
[13]FEMAN SP,NGUYEN LT,QUILTY MT,et al.Effectiveness of recruitment in clinical trials:an analysis of methods used in a trials:an analysis of methods used in a trial for irritable bowel syndrome patients[J].Contemp Clin Trials 2008,29(2):41-251.
[14]BISHOP FL,LEWITH GT.Patients’preconceptions of acupuncture:a qualitative study exploring the decisions patients make when seeking acupuncture[J].BMC Complement Alten Med,2013(13):102.
[15]LINDE K,WITT CM,STRENG A,et al.The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain[J].Pain,2007,128(3):264-271.
[16]SHERMAN K J,HAWKES R J,ICHIKAWA L,et al.Comparing recruitment strategies in a study of acupuncture for chronic back pain[J].BMC Med Res Methodol,2009(9):69.