Objective To investigate the reporting quality of randomized controlled trials (RCT) on laparoscopic surgery for treating colorectal disease in three SCI indexed. Methods We electronically retrieved the Ovid MEDLINE(R) from 1950 to present with Daily Updates for RCTs on laparoscopic surgery published in Diseases of the Colon amp; Rectum, International Journal of Colorectal Disease, or Colorectal Disease. The revised CONSORT statement and additional surgical items were adopted to assess the reporting quality. One point was assigned for each full description of an item, 0 for no description, and 0.5 for a partial description. Results A total of 20 RCTs were included and 8 RCTs were excluded. Their reporting quality was low. The average scores for the following items were relatively lower, 0.150 for settings where data collected; 0.250 for sample size estimation; 0.500 for sequence generation of randomization; 0.325 for allocation concealment; 0.150 for implementation; 0.475 for measurement of outcome; 0.150 for participant flow chart; 0.450 for adverse events; 0.450 for external validity; 0.400 for financial conflicts of interest; 0.250 for perioperative pharmacological treatment; 0.075 for perioperative nonphamacological treatment; 0.000 for participation of a trial methodologist; 0.350 for surgeon’s experience (years or position). Items with the lower scores were mainly in the methods and results section and surgical items. Conclusions The reporting quality of laparoscopic RCTs in these journals is low. Colorectal surgeons should rigorously evaluate reports in these journals before they apply to them in clinical practice.
The quality of reporting of randomized clinical trials could be significantly improved by the application of CONSORT （Consolidated Standards of Reporting Trials） statement. We compared and analyzed the difference of acceptance of CONSORT statement between Chinese medical journals and Western medical journals, and proposed to disseminate and apply CONSORT statement to improve the quality of reporting of randomized clinical trials and medical journals.
Within person trial is an efficient study design for randomized controlled trials which has been widely used in fields of dentistry, dermatology and ophthalmology. However, due to a series of inherent methodological difficulties, the design, conduct and reporting of within person trials usually requires additional methodological knowledge and considerations from researchers. To standardize and improve the reporting quality of these trials, the BMJ recently published the CONSORT statement extension for within person trials. The present article aimed to provide interpretation of this reporting guideline, and thereby promote its understanding and use among Chinese researchers.
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.
Surrogate endpoints, defined as biomarkers or intermediate outcomes utilized in clinical trials to replace the ultimate targeted outcomes, have witnessed a growing prevalence in both clinical trials and drug-device approvals in recent years. To standardize the application and reporting of surrogate endpoints in clinical trial protocols and associated studies, relevant scholars published the SPIRIT-Surrogate and CONSORT-Surrogate reporting guidelines in the BMJ in July 2024. This article provides an interpretation of these guidelines in conjunction with published case studies, with the aim of offering references for domestic researchers, elevating the overall quality of related clinical trials, and eventually facilitating the enhancement of domestic healthcare level.
ObjectiveTo evaluate the reporting quality of clinical randomized controlled trials (RCTs) published in five Chinese psychiatric journals from 2016 to 2020 and to compare the reporting quality with that from 2004 to 2008. MethodsRCTs in five Chinese psychiatric journals were collected through a computerized search of the CNKI, WanFang Data, and CBM databases and manual searches of paper journals, all with a search timeframe from 2016 to 2020. The CONSORT 2010 statement and two extensions (CONSORT extension for abstracts and CONSORT harms extension) were used to evaluate the RCTs. The criteria for reporting quality were the evaluation score, reporting proportion, and compliance proportion. The reporting quality of RCTs in the past 5 years was compared by year group. In addition, the RCT reporting quality from 2004 to 2008 was compared with that from 2016 to 2020. ResultsIn total, 226 RCTs were included. There was no statistically significant difference in the total evaluation score or abstract score from 2016 to 2020 (F=0.54, P=0.71; H=1.49, P=0.83). However, there were statistically significant differences in the harm scores from 2016 to 2020 (H=10.78, P=0.03). Further analysis of the items revealed statistically significant differences in the reporting proportion of items 16 and 19 (Fisher’s=8.61, P=0.04; χ2=11.63, P=0.02) and no significant differences in the other items (P>0.05). The reporting proportion of defined primary and secondary outcome indicators, allocation concealment, randomization implementation, outcomes and estimation, generalization, trial registration, and flow chart was <10% in each year. There was a statistically significant difference in the compliance proportion of RCT reporting quality from 2016 to 2020 versus 2004 to 2008 (39.54%±8.92% vs. 34.76%±9.16%, t=6.60, P<0.001). ConclusionThe reporting quality of RCTs in five Chinese psychiatric journals from 2016 to 2020 is better than that from 2004 to 2008. However, the reporting quality of RCTs within the latter 5 years still have reporting deficiencies in important items, and many aspects still are needed to be improved and enhanced.
ObjectiveTo investigate the methodological and reporting quality of clinical trials involving Xiaoyao San for chronic fatigue syndrome. MethodsWe searched PubMed, CBM, CNKI, VIP and WanFang Data to identify randomized controlled trials (RCTs) about Xiaoyao San for chronic fatigue syndrome. The methodological and reporting quality of included RCTs was respectively evaluated according to the assessment tool of risk of bias of the Cochrane Handbook 5.1.0 and the CONSORT 2010 statement, combined with complementary assessment by the characteristic indicators of traditional Chinese medicine (TCM). The methodological and reporting quality of included case series study was respectively assessed by the methods recommended by the Britain's National Institute for Clinical Excellence (NICE) and the STROBE statement. ResultsA total of 27 clinical trials were included, involving 11 RCTs and 16 case series studies. According to the assessment tool of risk of bias of the Cochrane Handbook, 54.5% of the RCTs performed proper random method, 9.1% conducted allocation concealment and blinding, 72.7% selected intention-to-treat (ITT) analysis without the report of loss to follow-up, and no RCT existed selective reports. Corresponding to the characteristic indicators of TCM, 54.5% of the RCTs did not conduct TCM syndrome diagnosis, the curative effect standard of TCM syndrome was discrepant, and no RCT was multi-center study. The CONSORT 2010 statement indicated that no RCT explained sample size estimation, implementation details of randomization, flow diagram of participant, use of ITT and clinical trial registration. According to the items recommended by Britain's NICE, 6.25% of the case series studies were multi-center, 81.25% did not report clear inclusion and exclusion criteria, and no case series study performed continuous patient recruitment and stratification analysis of outcome. The STROBE statement indicated that no case series study reported research design, sample size, flow chart, bias, limitations and generalizability. ConclusionThe quality of clinical trials about Xiaoyao San for chronic fatigue syndrome is still low in methodological and reporting aspects. It is suggested that the future clinical trials should be conducted with references of CONSORT statement and STROBE statement, to propel the modernization and internationalization of TCM.
ObjectivesTo evaluate the reporting quality of domestic and foreign randomized controlled trials (RCTs) on acupuncture for dry eye based on Consolidated Standards of Reporting Trials Expand Statement 2010 (CONSORT 2010) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).MethodsCNKI, VIP, CBM, WanFang Data, PubMed, EMbase and The Cochrane Library databases were electronically searched to collect RCTs of acupuncture for dry eye at home and abroad from inception to February 2020. The reporting quality of the selected literature was evaluated with the items in the CONSORT and STRICTA, respectively.ResultsA total of 69 Chinese literatures and 8 English literatures were included. The average reporting rate of all items of CONSORT in Chinese and English literatures was 41.4% and 56.4%, respectively. The missing items of Chinese literature report primarily focused on the sections of “methodology”, “results”, and “other information”. The Chinese and English literature report rate was relatively close in terms of the literature report rate of STRICTA, and both were relatively complete in the description of acupuncture intervention.ConclusionsThe reporting quality of RCTs of acupuncture treatment for dry eye in China and abroad is generally low. Further improving the relevant reporting quality according to the CONSORT statement 2010 and STRICTA 2010 is urgent.
Objective To investigate the current situation of randomized controlled trials (RCTs) on compound salvia pellet (CSP) for angina pectoris and assess whether there is adequate evidence for clinical practice. Methods We collected all the published clinical studies on CSP for angina pectoris from 1994 to December 2005, and assessed each included report using the Jadad scale, the revised CONSORT statement and other self-edited items. Results We finally identified 115 RCTs. Among which, 1 scored 3 points, 6 scored 2 points, 106 scored 1 points and 2 socred 0 points. No RCT performed allocation concealment according to the CONSORT criteria, only 4 RCTs (3.5%) described the generation of the randomization sequence, among which 2 were quasi-randomized. No RCT provided randomization implementation,1 RCT (0.9%) carried out placebo control, 1 RCT (0.9%) reported endpoint, 9 RCTs (7.8%) adopted single blinding, 4 RCTs (3.5%) reported double blinding, 11 RCTs (9.6%) calculated statistical values, 2 RCTs (1.7%) provided the record of follow-up, 1 RCT (0.9%) reported negative outcome, 25 RCTs (21.8%) described adverse events, no RCT described how the sample size was estimated, and how an intent-to-treat (ITT) analysis and correlation analysis were reported, 1 RCT (0.9%) was multi-center, no RCT completed ethical approval and informed consent, 27 RCTs (23.5%) described syndrome type of TCM. Conclusion Currently, the methodology and reporting of studies on CSP for angina pectoris are not good enough to provide reliable evidence for clinical practice.