ABSTRACT
Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial.In this paper , we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method . Methods According to the randomized sequence , a two-couplet random allocation should be prepared for every subject and bound into a book in order , which named random assignment book with cover and instructions .The first couplet is to collect the enroll information and the second couplet is to show the allocation informa -tion.The serial numbers of the two couplets which around sealant are the same , and leave blank at the same areas of the two couplets for signing the enter information .The content of the first couplet can be completely copied to the second couplet .In order to avoid expo-sing the allocation information in advance , the back of the second couplet should be black-printed. When the subjects are sure qualified, the researchers selected the corresponding two couplet in a sequential order .Exposing the allocation infromation in the second couplet, and the subjects will be allocated to the group designated on the second couplet .This random allocation book should be entrusted to professional printing mechanism ,printing according to the random assignment sequence table and in the strict quality control .For the multicenter clinical trials , it can be printed in parts . Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise . Conclusion The random allocation book method is easy to produce , simple operation and convenient in monitoring , which can effectively achieve the random allocation concealment in a clinical trial as well as having a sig -nificantly practical value in ensuring the quality of randomization .
ABSTRACT
Objective and fair clinical trials are the main methods for assessing the clinical significances of the experimental findings. The development of translational medicine highly relies on high-quality clinical trials as well as trial reports. Although the definition of"quality of clinical trials"and"quality of trial reports"differs from each other, they are closely related and can be consistent in most circumstance in the context of"scientific integrity". The quality of trial reports can be basically assessed by their internal and external properties. The quality of a randomized trial can be assessed by Jadad scale and Cochrane collaboration's tool for assessing risk of bias, and the quality of a non-randomized trial by risk of bias tool and Newcastle-Ottawa scale. However, since Jadad scale lacks appropriate appraisal of allocation concealment and is too simple in evaluating blind method, assessment of allocation concealment should be added. A more widely accepted approach for assessing the quality of random trials is the combination of Jadad scale and Schulz's approach to allocation concealment till recent years.For non-randomized cohort studies and case-control studies, Newcastle-Ottawa scale might be suitable at present time.
ABSTRACT
BACKGROUND: Because low quality trials may lead to wrong conclusions, quality assessments are necessary. Thus, this study scrutinizes randomized controlled trials (RCTs) in the Journal of the Korean Academy of Family Medicine (KAFM) to assess the quantity and the quality. METHODS: Upon extracting randomized controlled trials from all the articles published in the Journal of the KAFM from 1980 to 2005, assessments were made on the Jadad scale and the adequacy of allocation concealment. The selections and assessments were performed independently by two researchers, and adjustment of the differences were done by a third-party researcher. In addition, the factors that may affect the quality levels were analyzed. RESULTS: Twenty-three trials were included. In 1980s, there were only 1.09% of the total original articles, but in 2000s, 2.63% were RCTs. The mean total Jadad score increased from 1 point in 1980s to 2.17 in 2000s, and the "good quality" trials also increased from 0% to 33.33%. As for the adequate allocation concealment, however, only two studies were observed in 2000s. The most lacking aspect was the appropriate double-blinding. Also, studies intervened by medicine or funded or examined by Institutional Review Boards (IRBs) tended to receive higher quality assessments. CONCLUSION: Although RCTs consistently increased in quantity and quality, in future studies, researchers should continue to strive towards achieving adequate allocation concealment and appropriate double-blinding. In addition, researchers must become more interested in receiving funds and examination by IRBs.