中华心血管病杂志部分治疗性研究文献的分析和评价  

Assessment of the intervention studies published in Chinese Journal of Cardiology

作　　者：李静[1] 王家良[1] 俞红吉[1] 

机构地区：[1]华西医科大学第一临床医学院临床流行病学教研室,成都610041

出　　处：《中华心血管病杂志》2000年第2期135-139,共5页Chinese Journal of Cardiology

摘　　要：目的　 (1)分析确定非随机试验中应该采用随机对照试验 (RCT)的比例 ;(2 )评价RCT的质量 ,发现治疗性研究文献中存在的方法学缺陷 ,为提高临床科研质量提供信息。方法　手工检索1996～ 1998年发表在中华心血管病杂志上的所有治疗性研究文献 ,分析未采用随机、对照、盲法的文献其采用RCT和盲法的可行性 ;对采用RCT者 ,分析其采用的随机方法是否完善、是否有基线情况的报告以及对失访者的处理是否恰当。结果　检出 85篇治疗性研究 ,RCT为 36篇 (占 42 4% ) ,49篇未采用RCT。有 36篇无对照组的研究 ,其中应该采用对照有 2 1篇 (占 5 8 3% ) ;在 13篇有对照而未采用随机方法分配受试对象的研究中 ,6篇 (46 2 % )应该将研究对象随机分配入组 ;6 9篇未采用盲法的研究中 ,2 9篇 (42 0 % )至少应该对结果测量者采用盲法。 36篇RCT中 ,33篇均未描述产生随机分配方案的方法 ,3篇描述了采用随机分配的方法 ,2 8篇提供了基线资料。 10篇RCT有研究对象中途退出研究 ,只有 2篇文献将退出者纳入结果分析中。结论　作为治疗性研究“金方案”的RCT的应用仍不够广泛 ,且存在一定的缺陷和问题。作者在报告时应该向读者提供有关随机、对照、盲法、基线情况、失访及其处理、样本估算等方面的详细信息 ,以便读者评价文献的?Objective To determine whether randomized controlled trial (RCT) methodology was used appropriately in papers of Chinese Journal of Cardiology, we (1) determined the proportion of non randomized studies that should have been RCTs, and (2) assessed reporting quality of the RCTs. Methods All studies assessing effects of intervention from 1996-1998 published in Chinese Journal of Cardiology were handsearched. Studies that did not use control, randomization or blindness were analyzed for their feasibility of RCT methods and blindness; RCTs were analyzed for the adequacy of randomization, baseline comparisons and appropriate handling of treatment violators. Results Eighty five intervention studies were identified and 42 4% (36/85) was RCTs. Of those without control, 58 3% (21/36) should have; of those not using randomization while having a control, 46 2% (6/13) should have; of those not using blindness, 42 0% (29/69) should have at least single blindness on outcome assessors. Among the 36 RCTs, only three studies described the method for generating random sequence, one study reported the method of allocation concealment, 77 8% (28/36) of the RCTs contained baseline comparisons of key variables that might affect the outcome of interests. Only 2 of the 10 RCTs, which had treatment violators, used intention to treat analysis. Only one study mentioned sample size estimation. Conclusions RCT is regarded as the “gold standard” for evaluation of the effects of interventions. RCTs in this Journal are underused and the reports provide inadequate information on treatment allocation. Given the deficiency of methodological rigor and the importance of quality of primary studies in producing unbiased systematic reviews, the quality of reporting of RCTs with relevant information on the design, conduct, analysis and generalizability of trials must be emphasized.

关 键 词：期刊 《中华心血管病》 治疗性研究文献 评价 

分 类 号：G257[文化科学—图书馆学]