Title: Assessment of the intervention studies published in Chinese Journal of Cardiology
Abstract: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 studi...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.Read More
Publication Year: 2000
Publication Date: 2000-01-01
Language: en
Type: article
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