Identification and authentication of claimed RCTs for Cochrane systematic review

Article type
Authors
Zhuo Q, Wu T, Yang X, Zeng X, Yuan Y
Abstract
Background: More than 90% claimed RCTs published in China are not real RCTs due to the original authors having misconceptions of randomization. We developed a method to identify the authentication of such ‘RCTs’ and to assess the quality of authentic RCTs. Methods: We raised a question based on the fact that most Chinese claimed RCTs were formulated retrospectively and were the collection of the authors’ experience in their daily clinical practice. We investigate the key issue, whether a study protocol had been developed beforehand, by the means of interviewing the original authors via telephone. Questions and procedure: 1. Did you develop a study protocol before recruiting the participants? If the answer is negative, the study will be judged as a false ‘RCT’, and will be excluded. If the answer is positive, the second question will be asked. 2. Who generated the allocation sequence? If it was the author or statistician, we will ask the next question. 3. What method did you use to generate the sequence? Or did you know what method was used? 4. How did you treat the allocation sequence? 5. Did you take any funding from anywhere? 6. Who paid for the trial materials and related examinations? 7. How did you assess the results of treatment? Results: After contacting the second time all the authors of the 27 included studies in three reviews by the new interview schedule described above, we discovered an interesting result: of the 27 included ‘RCTs’ judged by the old interview schedule, 12 did not develop a protocol previously. They were thus judged as retrospective studies and only 15 with study protocol were judged as authentic RCTs. Consequently, one published Cochrane systematic review (CSR), ‘‘Chinese Medicinal Herb for Influenza’’, and another two being peer-reviewed now, ‘‘Traditional Chinese interventions for Stable Angina’’ and ‘‘Tongxinluo capsule for acute stroke’’ only identified 10 studies (another 5 excluded for other reasons) as authentic RCTs, by contrast 27 claimed ‘RCTs’ were included in original versions. We will update all of our published CSRs and making new CSRs according to the new method to identify the authentication of claimed RCTs published in China.