THE QUALITY OF REPORTING OF RANDOMIZED CONTROLLED TRIALS IN PELVIC ORGAN PROLAPSE IN CHINA
HE1, Y. WANG 2, J. HAN 3;
1OB & GY, Peking Univ. Third Hosp., Beijing, China, 2Peking Univ. Third Hosp., Beijing, China, 3Dept. of Obstetrics and Gynecology, Peking Un, Beijing, China.
Introduction: Randomized controlled trials (RCTs) must comply with the strict rules of design and conduct and their reporting should reflect it.
Objective: Our aim was to evaluate how the quality of RCT reporting in pelvic organ prolapse (POP) in China has evolved.
Methods: RCTs in POP published in Chinese core journals between 1996 and 2015 were retrieved through a CBM (Chinese BioMedical Literature Database) search. The quality of reporting was assessed by applying the 2010 revised Consolidated Standards of Reporting Trials (CONSORT) statement. Appropriate statistical analysis was performed.
Results: (1) Thirty-two RCTs were identified for review, in which 94% were published after 2010. Eight RCTs (25%) were about Traditional Chinese Medicine and 24 (75%) were related to western medicine treatment. (2) The following 14 items were not reported in any of the 32 RCTs: identification as a randomised trial in the title, trial design, any changes to trial outcomes after the trial commenced, sample size, allocation concealment mechanism and implementation, blindness, participants flow, the reason of ending trail, numbers analysed, outcomes and estimation, ancillary analyses, trail registration and protocol acquiring. (3)The scientific background and explanation of rationale(2a,43.4%), specific objectives or hypotheses(2b,46.9%), method used to generate the random allocation sequence(8a,31.3%),baseline material(15,34.4%), harms(19,40.6%), interpretation consistent with results (22,21.9%)and funding(25,6.3%)were reported in less than half of the trial. (4)The reporting quality of RCTs about western medicine was significantly superior to the Traditional Chinese Medicine in the introduction of background and objectives, statistical methods and baseline data reporting according to the CONSORT criteria.
Conclusions: RCTs in POP are scarce in China. The quality of reporting is suboptimal in many aspects.
References: 1.BMJ. 2010.doi:10.1136/bmj.c869