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OBJECTIVE@#To evaluate the report quality of Chinese and English randomized controlled trials (RCTs) of acupuncture based on the CONSORT statement and STRICTA checklist.@*METHODS@#The Chinese and English RCTs of acupuncture published from January 1, 2015 to December 31, 2019 were searched in 7 databases including PubMed. The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist.@*RESULTS@#A total of 506 Chinese RCTs and 76 English RCTs were included. According to the CONSORT statement, in Chinese RCTs, the items with report rate less than 50% accounted for 78.38% of all items, and the report rate of 25 items, such as background and reason, study design, outcome index, and sample size, was less than 10%. In English RCTs, the items with report rate less than 50% accounted for 35.14% of all items, and 5 items had a report rate of less than 10%. The difference of the report rate of 15 items, such as background, reason and study design, was more than 50% between Chinese and English RCTs. The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs. In Chinese RCTs, the items with report rate less than 50% accounted for 29.41% of all items, which included acupuncture rationale and depth of insertion. In English RCTs, only two items had a report rate less than 50%, which were acupuncture rationale, setting and context of treatment. The report rate of five items, including needle retention time, frequency and duration of treatment sessions, details of other interventions administered to the acupuncture group, setting and context of treatment, and precise description of the control or comparator in Chinese RCTs, were higher than in English RCTs.@*CONCLUSION@#The report quality of Chinese acupuncture RCT needs to be improved urgently, and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.
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Humans , Acupuncture Therapy , Checklist , Randomized Controlled Trials as Topic/standardsABSTRACT
<p><b>OBJECTIVE</b>To evaluate and compare the reports' qualities of acupuncture randomized controlled trials (RCTs) conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials (CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).</p><p><b>METHODS</b>Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item's reporting were calculated and reported differences during different date ranges were compared.</p><p><b>RESULTS</b>For CONSORT items (maximum score 8), there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined (2.5±0.6) and 2004-2005 and 2009-2010 combined (3.0±0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P<0.01). For STRICTA items (maximum score 17), there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined (8.6±2.1) and 2004-2005 and 2009-2010 combined (10.1±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P<0.01).</p><p><b>CONCLUSION</b>Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.</p>
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Humans , China , Guidelines as Topic , Randomized Controlled Trials as Topic , Reference Standards , Research Report , Time FactorsABSTRACT
Objective To explore the quality of clinical trial papers published in medical SCI-tech journal.Methods A total of 1201 original research projects were published in 6 medical journals from Mar.2012 to Mar.2014 in China.Fifty-four of them were selected according to the key words randomizedcontrolled,and they were evaluated using 2010 CONSORT statement.Results In 54 articles,the section of background and abstract were described clearly and standardize.Fifty-one (94.44 ％)papers described intervention method in details.Thirty-five (64.81％) papers described the experimental design method.Thirty-one (57.41％) papers defined the primary and secondary outcome indicators,only 3 (5.56％)of them described distribution order,and the method of blindness.Four (7.41％) papers provides the information on sample size calculation.The using of flow chart accounted for 7.41％.Ten (18.52％) papers described the reason of drop out.Two (3.70％) papers evaluated the effect and accuracy,and the trial results were explained clearly and consider other evidences.Only 18 (33.33％) papers wrote the limitation of the studies.For other information of the studies,5 (9.26％) of them was registered somewhere,the information on funding support was on 20 (37.04％)papers.Conclusions The description on most RCT papers were clear and complete,but close attention should be paid to the method of blindness and sample size determine.
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Objective To search and evaluate the quality of reports of clinical trial studies published in Chinese Pediatric Emergency Medicine according to CONSORT statement.Methods We collected all articles published in Chinese Pediatric Emergency Medicine from January 1,2011 to November 31,2015 through searching the WanFang Database,then evaluated and analyzed clinical trial studies.Results Among all 1317 articles we retrieved,62 (4.7％)of them belong to clinical trial study.According to CONSORT statement,all the articles satisfied items from 1b to 6b (including abstract,introduction,trial design,participants,interventions and outcomes),only 30(48.4％) and 4(6.5％) articles mentioned item 8a (method used to generate the random allocation sequence)and 8b(type of randomization;details of any restriction),respectively.None of the editors reported item 9(mechanism used to implement the random allocation sequence,describing any steps taken to conceal the sequence until interventions were assigned)and 10(who generated the random allocation sequence,who enrolled participants,and who assigned participants to interventions).Among 62 included studies,33(53.2％)studies concentrated on respiratory system diseases.However,studies about nervous system,circulatory system and digestive system were 5(8.1％),4(6.5％)and 4 (6.5％) respectively.Although all the results had statistical significance,only 38(61.3％),7(11.3％) and 5 (8.1％)mentioned randomization,follow-up and blinding respectively.Flow diagram was only included in one (1.6％) article.Conclusion The articles of clinical trial studies published in Chinese Pediatric Emergency Medicine did not take CONSORT statement as reference completely.
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Objective To assess the quality of randomized controlled trials(RCT)abstracts published in Journal of Clinical Anesthesiology by CONSORT for Abstracts.Methods Articles invol-ving human RCTs published from 2012 to 2013 were reviewed and searched through WanFang Med Online.Trials involving animal experiments,in vitro,RCTs without abstract,and meta-analyses were excluded.According to the CONSORT checklists for abstracts,the quality of abstracts for RCT were assessed.Results In total,392 RCT abstracts were analysed.The median word counts of ab-stracts was 364 (IQR 306-444),sample size was 60 (IQR 40-80).Almost all abstracts provided an appropriate description of conclusions (100%), numbers randomized (99.0%) and objective (99.0%).The majority of abstracts described interventions (94.6%)and participants (82.4%).Re-quirements present in less than 50% of the abstracts were details regarding trial design (46.2%)and harms (48.7%).The descriptions of randomization (13.3%),blinding (1.8%),methods-outcome (3.6%)and results-outcome (9.7%)were very low.Moreover,title,recruitment and numbers ana-lysed were not reported.Conclusion The quality of RCT abstracts and adherence to the CONSORT checklist for abstracts remains poor,and the CONSORT for Abstracts should be endorsed to improve the quality of RCT abstracts as early as possible.
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Objective To investigate the current situation of randomized controlled trials (RCTs) on the treatment of chronic obstructive pulmonary disease (COPD) in stationary phase with point application, and provide evidence for clinical practice. Methods Such databases as CNKI, VIP, and CBM were searched from the establishment date to October 2011 to collect the RCTs on the treatment of COPD in stationary phase with point application according to the predefined inclusion criteria. And the quality was assessed by using the Jadad scale, the revised CONSORT statement and other self-defined indexes. Results Among 32 included RCTs, 1 literature scored three points, 8 scored two points, 23 scored one point according to Jadad scale, and no RCT performed the allocation concealment. According to the CONSORT criteria, only one can be prompted randomized trials from the title of the article, 23 from abstracts, 2 literature showed how to determine the sample size, 7 described the method to generate random allocation sequence, only 1 literature mentioned blind method, 15 literature explicitly mentioned syndromes. Conclusion Currently, the methodology and reporting quality of studies on the treatment of COPD in stationary phase with point application are not good enough to provide reliable evidence for clinical practice, and we should improve the quality of our clinical research.