Bee venom acupuncture for the treatment of

1、附表1 SPIRIT清单分配及评价表SPIRIT清单分配及评价表一、被评论文标题：Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial 二、评价者姓名： 单位科室： 手机： 邮箱： 说明：1.原文报告者为：“是”，未报告者为“否”， 2.如遇到原文未涉及到的条目，而作者未予以说明者，暂且按：“否”计算，如有争议的根据情况再讨论分析； 3.最后汇总。论文部分条 目分配内容评价是否

2、报告题目1标题中描述研究设计、研究对象、干预措施。如果适用写出试验缩略词Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlledtrial试验注册2a试验标识符和注册的名称。如果还没有注册，预计可能注册的名称NCT014913212b所有项目都来自于世界卫生组织试验注册数据集(可在查到附录表)未提及方案版本3方案版本确定的日期和版本号未提及资金4资金、材料和其他支持

3、的来源、类型。This work was supported by a grant from Kyung Hee University in 2010(KHU-20101884).角色和职责5a方案贡献者的姓名、单位和角色BKS is responsible for developing the treatment protocol, carrying out the clinical study and drafting the manuscript. JHL contributed to the study conception and design, participated in th

4、e acquisition of data and revised the manuscript. WSS and EMS carried out the clinical study and participated in manuscript drafting. DJJ contributed to the design of the study and supervised the protocol fulfillment and the acquisition of funding for the study. All authors have read, revised and ap

5、proved the final manuscript.5b试验赞助者的姓名和联络方式未提及5c明确研究赞助者和公司的角色,例如在研究设计;收集、管理、分析和解释数据;撰写报告,决定提交报告出版等方面。包括他们是否将有最高权威的这些活动未提及5d如果有协调中心、指导委员会、终点裁定委员会、数据管理团队和其他个人或团体监督此试验，说明其成分、角色和职责。 (见条目21对 DMC的说明)未提及介绍背景和理论基础6a描述实施此试验研究的问题和理由，包括总结相关研究(已发表和未发表的)，检查每个干预的好处和坏处详细提及6b解释选择的对照组未提及目标7特定目标或假设a rigorous randomiz

6、ed controlled trial is needed to develop clinical indications and a manual for the optimal practical guidelines of BVA试验设计8试验设计的描述,包括试验的类型 (如平行组、交叉、阶乘、单组),分配比和框架(如优效性、等效性、非劣效性、探索性)This study is a randomized, double-blinded, shamcontrolled clinical trial with two parallel arms. We intend to compare t

7、he effects of BVA and pharmacotherapy with sham-BVA and pharmacotherapy in patients with CLBP.方法参与者,干预措施和结果研究场所9描述研究场所(例如社区诊所、学术医院)，收集数据的国家名单。提及的研究场所名单能被获得Kyung Hee University Hospital at Gangdong,纳入标准10受试者的纳入和排除标准。如果可以，写明研究中心和个人谁将纳入患者(如外科医生、心理咨询师) 纳入和排除标准提及Participants will be recruited through adv

8、ertisements in local newspapers, on hospital websites and on bulletin boards. If patients are interested in participation, they will be asked to answer screening questions to determine their eligibility. If eligible, they will be guided through the informed consent process. After written consent is

9、obtained, a study researcher will administer the baseline questionnaire then randomly allocate the participants into the real or sham BVA group. After randomization, the interviewer will schedule the treatment procedure. All recruit procedures will be recorded in a log file干预措施11a足够详细的描述每组干预措施以便重复,包

10、括如何执行干预措施以及何时执行干预措施详细描述，table111b给一个既定的试验参与者制定终止或修改分配干预的标准(如应对药物剂量改变导致的不良反应、参与者的需要、或改善/恶化的疾病) Participation in can be ended at any stage if the patient refuses to continue or in the presence of significant clinical deterioration, as determined by the attending KMD researchers. For those participants

11、 who will be lost to follow-up and who dropout, intention-to-treat analysis will be applied to the existing data (Table 2).11c制定策略来提高干预方案的依从性以及完善任何监测依从性的程序(如药物回收,实验室测试)未提及11d在试验期间，哪些相关保健和干预措施是被允许或禁止的all participants will receive a copy of the Exercise Manual for Patients with Low Back Pain from the

12、spine center of KHUHGD and will be encouraged to exercise according to the manual during the entire treatment period. all the participants will be prescribed loxonin (Loxoprofen, 60 mg/tablet; Dong Wha Pharm Co., Ltd., Seoul,Korea) per os one tablet three times a day throughoutthe treatment period结果

13、12主要的,次要的,和其他的结果,包括特定的测量变量(如收缩压)、分析指标(如基线的改变、终值的改变、时间事件的改变)、收集方法(如中值、比例),和每个结果的时间点。解释的临床相关性的功效和危害结果的选择是强烈推荐详细提及参与者时间表13形成登记、干预(包括任何争执和褪色)、评估和随访参与者的时间表。高度推荐做一个示意图(图) 样本大小14估计需要完成研究目标的参与人数和它的确定方式,包括临床和统计假设支持任何样本大小的计算We have performed sample size calculations for CLBP according to another acupuncture s

14、tudy on the same disease using the same primary outcome measure because no such BVA research has been reported The expected mean difference and common standard deviation between the two groups are estimated (mean difference = 1.5, SD = 2.73) according to that former acupuncture research 28 on CLBP u

15、sing the 10-cm VAS as a primary outcome measure. For two arms (control-sham BVA and experimental-BVA), we consider the two-sample t-test model. Twenty-seven participants will be required per intervention group to achieve 0.80 power (1-) at the 0.05 level after adjusting for a 20% attrition rate.招聘15

16、制定策略使得所招募的参与者能够达到目标样本量Participants will be recruited through advertisements in local newspapers, on hospital websites and on bulletin boards.分配的干预(对照试验) 分配序列生成16a生成分配序列的方法(如计算机生成的随机数)和列出任何因素的分层。减少一个随机序列的可预测性,任何限制设计的细节(如盲法)应以一个单独文件的形式被提供,不可用那些报名参与者或分配的干预措施Randomization will be undertaken through a co

17、mputerized software randomization program by an independent statistician who is concealed with respect to the patients.16b分配序列的实施机制(如中心电话，顺序编号，不透明，密封信封),描述从隐藏序列到干预分配的所有步骤。Participant details will be recorded, and the treatment arm and randomization number will be allocated to the patients; both of t

18、hese are included in the participants hospital files. The randomization form will becompleted and returned to the principal investigator.16c谁生成分配顺序,谁招纳参与者,谁将分配参与者参与干预。randomization program by an independent statisticianParticipants will be recruited through advertisements in local newspapers, on hos

19、pital websites and on bulletin boards. study researcherParticipant details will be recorded, and the treatment arm and randomization number will be allocated to the patients设盲（隐藏）17a谁会在分配干预后被盲(如试验参与者、护理提供者、结果评估者、数据分析师)，以及如何被盲。the researcher performing the outcome measure assessments will be blinded

20、to the patients treatment allocation. Furthermore, the people who administer treatments will be blinded as to whether the patientreceives real or sham BVA, and the pharmacopunctures will be prepared by independent researchers17b在试验过程中如果设盲，何种情况下是允许揭盲的，如何揭示一个参与者的分配干预过程。未提及数据收集方法18a拟定评估和收集结果、基线、其他试验数据的

21、计划，包括任何相关流程以保证数据质量(如重复测量，评估者培训)和一个描述的研究工具(如问卷调查、实验室检测)以及它们的可靠性和有效性。如果已知，写出引用的数据收集形式；如果不是，在方案中说明。A series of measurements to assess back pain-related dysfunction, pain, quality of life and adverse experiences will be collected at baseline and week 1, 2, 3, 4, 8 and 12.At the screening visit, patients

22、 will be asked to fill out a questionnaire regarding their sociodemographic characteristics, including age, gender, marital status, residence, occupation and education level. A medical history will be also taken before their physical check-ups, and these factors will determine their eligibility for

23、our study.18b做一个促使参与者保留和完整随访的计划，包括列出所有从干预方案中退出或脱落患者的结果。Participation in can be ended at any stage if the patient refuses to continue or in the presence of significant clinical deterioration, as determined by the attending KMD researchers. For those participants who will be lost to follow-up and who

24、drop out, intention-to-treat analysis will be applied to the existing data数据管理19做一个数据录入、编码、安全性和存储的计划，包括任何相关流程以提高数据质量(如双数据输入；数据值的范围检查)。参考细节数据管理过程可以发现；如果不是，在方案写明。未提及统计方法20a列出分析主要和次要结果的统计方法。如果有参考其他详细的统计分析计划可列出；如果不是，在方案写明。The statistical analysis will be performed in the principle of intention-to-treat

25、analysis and per-protocol analysis. For the intention-to-treat analysis, data will be processed with the last observation carried forward method. A homogeneity test of the baseline characteristics will be performed on both demographical and clinical data using a two-sample t-test for quantitative da

26、ta and a chi-square test for qualitative data. The two-sample t-test will be used for the VAS to evaluate the bothersomeness of LBP at baseline and again at four weeks (primary endpoint) for the comparison of the two groups and to determine differencesfrom baseline. All statistical analyses will be

27、carried out with the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL,USA) for Windows version 18.0, and a significance level of 0.05 will be used.20b任何其他的分析方法(如子群和调整分析)For each outcome variable, an analysis of covariance will be performed on the data to adjust the baseline chara

28、cteristics. Trends over time and time-by-treatment interactions will be explored using a repeated measures analysis of variance.20c定义分析人口相关方案的不依从性(例如作为随机分析)，以及任何统计方法来处理缺失数据(如多个因素)A chi-square test or a Fishers exact test will be performed to determine the difference between groups and the adverse ef

29、fects, which will be recorded and described as frequency and percentage.数据监查21a成立DMC，总结其角色和报告其结构；声明其是否独立于赞助者和是否有利益冲突；参考更多细节关于其章节中可以发现。如果在方案中没有DMC，写明为什么不需要DMC。未提及21b描述任何临时分析和终止准则，包括谁将评估这些中间结果和作出最后决定终止试验。Participation will be ended at any stage if the patient refuses to continue, withdraws consent, vi

30、olates inclusion or exclusion criteria or the trial protocol, or completes less than four treatment sessions as determined by the attending KMD researchers. The trial will be stopped if the principleinvestigator believes that there are unacceptable risks of serious adverse events.不良事件22做一个计划，针对收集、评估

31、、报告和管理请求、自发报告不良事件和其他意想不到的效果的试验干预或试验指导。Any adverse experiences at any visit during the six treatment sessions will be monitored. The research team will review all trial protocols, monitor patient safety and investigate any adverse events, which are defined as treatmentrelated experiences.审计23频率和程序审计实验指导，若有的话，实施这个过程的人员将独立于调查员和赞助者。未提及伦理和传播研究伦理批准24计划寻求REC / IRB的批准s approved by the Institutional Review Board of Kyung Hee University Hosp