方积乾教授讲座讲稿.doc
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1、精心设计和报告临床研究- 解读CONSORT方积乾 (中山大学公共卫生学院)前言推荐一篇文章The CONSORT Statement for Reporting Randomized Trials:Explanation and Elaboration作者:Altman, Schulz, Moher, Egger, Davidoff, Elbourne, Gtzsche and Lang for the CONSORT Group.杂志: Annals of Internal Medicine,Volume 134 Number 8 66317 April 2001。什么是 CONSORT
2、Statement?Consolidated Standards of Reporting Trials : CONSORT statement(JAMA, 1996)DerSimonian and colleagues (N Engl J Med, 1982) 建议“编辑向作者提供一份他们希望认真报告的项目清单将会大大改善临床试验报告的质量” 。早在1990年代,两组杂志编辑、试验人员和方法学专家独立地发表了关于试验报告的建议 (JAMA, 1994)。接着,Rennie (JAMA, 1995) 强烈要求这两个小组会面,并发展一套共同的建议; 其成果就是 CONSORT statement
3、. 此后,CONSORT statement的修改始于1999年. 2001年,The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials 同时发表于ANN Intern Med. , JAMA 和 Lancet 三个杂志,作者是The CONSORT Group。CONSORT statement (Consolidated Standards of Reporting Trials): (1) 医学报告基本项目的
4、清单(checklist) (2) 医学试验的病人流程图 (Flow Chart)许多杂志,如 The Lancet, British Medical Journal, Journal of the AmericanMedical Association, Annals of Internal Medicine, Journal of Hand Surgery, Journal of Pediatric Psychology 和越来越多的生物医学编辑部,如 The International Committee of Medical Journals Editors (Vancouver Gr
5、oup)和 The Council of Science Editors 都正式支持CONSORT.当人们必须做观察时,总是可能有偏倚.良好设计的随机对照试验(RCT)是干预效果的最佳证据; 但方法学不当会夸大疗效;粗糙设计和报告的试验会误导医疗卫生决策.Table 2. Checklist of Items To Include When Reporting a Randomized TrialPaper Section and TopicItemNumberDescriptorTitle and abstract1How participants were allocated to int
6、erventions (e。g。, “random allocation, “randomized” or “randomly assigned)。IntroductionBackground2Scientific background and explanation of rationale。MethodsParticipants3Eligibility criteria for participants and the settings and locations where the data were collected.Interventions4Precise details of
7、the interventions intended for each group and how and when they were actually administered。Objectives5Specific objectives and hypotheses.Outcomes6Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple obser
8、vations, training of assessors).Sample sizeRandomization7How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules。Sequence generation8Method used to generate the random allocation sequence, including details of any restriction (e。g。, blocking, strat
9、ification)。Allocation concealment9Method used to implement the random allocation sequence (e.g。, numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned。Implementation10Who generated the allocation sequence, who enrolled participants
10、, and who assigned participants to their groups。Blinding (masking)11Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated。Statistical methods12Statistical methods used
11、to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses.ResultsParticipant flow13Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly as
12、signed, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome.Describe protocol deviations from study as planned, together with reasons.Recruitment14Dates defining the periods of recruitment and followup。Baseline data15Baseline demographic and clinical cha
13、racteristics of each group。Numbers analyzed16Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention to treat。” State the results in absolute numbers when feasible (e.g., 10 of 20, not 50)。Outcomes and estimation17For each primary and s
14、econdary outcome, a summary of results for each group and the estimated effect size and its precision (e。g。, 95 confidence interval)。Ancillary analyses18Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified an
15、d those exploratory.Adverse events19All important adverse events or side effects in each intervention group.DiscussionInterpretation20Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyse
16、s and outcomes.Generalizability21Generalizability (external validity) of the trial findings。Overall evidence22General interpretation of the results in the context of current evidence. From references 5658.Figure 1. Revised template of the CONSORT (Consolidated Standards of Reporting Trials) diagram
17、showing the flow of participants through each stage of a randomized trial (5658).MethodsItem 3a。 Eligibility criteria for participants. (参加者合格的标准)Example all women requesting an IUCD intrauterine contraceptive device at the Family Welfare Centre, Kenyatta National Hospital, who were menstruating reg
18、ularly and who were between 20 and 44 years of age, were candidates for inclusion in the study. They were not admitted to the study if any of the following criteria were present: (1) a history of ectopic pregnancy, (2) pregnancy within the past 42 days, (3) leiomyomata of the uterus, (4) active pelv
19、ic inflammatory disease, (5) a cervical or endometrial malignancy, (6) a known hypersensitivity to tetracyclines, (7) use of any antibiotics within the past 14 days or longacting injectable penicillin, (8) an impaired response to infection, or (9) residence outside the city of Nairobi, insufficient
20、address for followup, or unwillingness to return for follow-up (74).在Kenyatta National Hospital 家庭福利中心要求宫内避孕装置IUCD的所有妇女, 有正常月经,年龄在20与44岁之间均可纳入研究。如果发生以下任何一项,不可进入研究:(1)异位妊娠史,(2)前42天内怀孕,(3)子宫平滑肌瘤,(4)现患骨盆炎性疾病PID,(5)宫颈或子宫内膜恶性肿瘤,(6)已知四环素过敏,(7)前14天内用过任何抗生素或长期注射青霉素,(8)弱感染反应,(9)Nairobi以外的居民,随访地址不详,或不愿返回做随访。E
21、xplanation研究者通常用“eligibility criteria来限定一个人群,并在这个人群中选择一、二个中心进行试验。 “Eligibility criteria”:年龄、性别、临床诊断、病情“Exclusion criteria”:常为保障病人安全。 l 计划书上必须准确描述“Eligibility criteria”和“Exclusion criteria”-以便研究者据此实施和报告,读者据此判断研究结果可以应用到什么范围.Item 3b。 The settings and locations where the data were collected。(收集数据的地方和位置)
22、ExampleVolunteers were recruited in London from four general practices and the ear, nose, and throat outpatient department of Northwick Park Hospital. The prescribers were familiar with homoeopathic principles but were not experienced in homoeopathic immunotherapy (79).从伦敦的四家全科医生和Northwick Park Hosp
23、ital的耳鼻喉科招募志愿者。推荐的医生熟悉顺势疗法的原则,但没有顺势免疫治疗的经验(79)。Explanationl 必须报告是否多中心,Settings和医务人员的数量-“Settings and locations影响该试验可推广的范围。 Item 4。 Precise details of the interventions intended for each group and how and when they were actually administered.(确切描述各组干预的细节以及如何、何时实施)。ExamplePatients with psoriatic arthr
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