Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist / 中国针灸

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.

Fecal Microbiota Transplantation for Ulcerative Colitis:An Overview of Systematic Review/meta-analysis / 胃肠病学

Background:The morbidity of ulcerative colitis(UC)is high,and is easily recurrent.A number of systematic review/meta-analysis have explored the efficacy and safety of fecal microbiota transplantation(FMT)in the treatment of UC with varying conclusions,however,the quality of these studies has not yet been adequately assessed.Aims:To overview the systematic review/meta-analysis of FMT for UC.Methods:Systematic review/meta-analysis of FMT in the treatment of UC were retrieved from PubMed,Cochrane Library,Embase,Web of Science,CNKI,CBM,Wanfang,VIP and other databases from the date of database establishment to May 2023,while gray literatures were searched and experts were consulted.Literature screening and extract information were performed by two researchers.The PRISMA checklist,AMSTAR-2 tool was used to assess the reporting quality and methodological quality,respectively,as well as to grade the quality of evidence for outcome measurements based on the GRADE system.Results:Seventeen systematic review/meta-analysis were finally included.The original studies included randomized controlled trials and observational studies.Most of the studies drew positive conclusions about the efficacy and safety of FMT in the treatment of UC.The PRISMA checklist score was 12.5-22.5,and the mean score was 17.68.Three studies reported relative completeness;ten had some deficiencies;and four had relatively serious report deficiencies.AMSTAR-2 tool showed that two were of intermediate quality,three were of low quality,and twelve were of very low quality.GRADE system ratings showed that six of the eight outcome measurements were of intermediate quality and two were of low quality.Conclusions:FMT may be a safe and effective treatment for UC,but the quality of the current evidence is low and users of clinical evidence need to treat the above evidence with caution.

Fecal Microbiota Transplantation for Ulcerative Colitis:An Overview of Systematic Review and Meta-analysis / 胃肠病学

Background:Ulcerative colitis(UC)is highly prevalent and recurrent.A number of systematic review/meta-analysis have explored the efficacy and safety of fecal microbiota transplantation(FMT)in the treatment of UC with varying conclusions,however,the quality of these studies has not yet been adequately assessed.Aims:To overview of systematic review/meta-analysis of FMT for UC.Methods:Systematic review/meta-analysis of FMT for the treatment of UC were retrieved from PubMed,Cochrane Library,Embase,Web of Science,CNKI,CBM,Wanfang,VIP and other databases from the date of database establishment to May 2023,while gray literature was searched manually and experts were consulted.Literature screening and extract information were performed by two researchers.The PRISMA checklist,AMSTAR-2 tool was used to assess the reporting quality and methodological quality,respectively,as well as to grade the quality of evidence for outcome measurements based on the GRADE system.Results:Seventeen systematic review/meta-analysis were finally included.The original studies included randomized controlled trials and observational studies.Most of the studies drew positive conclusions about the effectiveness and safety of FMT in the treatment of UC,but some of them only made inferences about possible effectiveness.The PRISMA checklist score was 12-22.5,and the mean score was 17.68.Four studies(23.5%)reported relative completeness;nine(52.9%)had some deficiencies;and four(23.5%)had relatively serious information deficiencies.AMSTAR-2 score showed that two were of intermediate quality,three were of low quality,and twelve were of very low quality.GRADE ratings showed that five of the eight outcome measurements were of intermediate quality and three were of low quality.Conclusions:FMT may be a safe and effective treatment for UC,but the quality of the current evidence is low and users of clinical evidence need to treat the above evidence with caution.

Reporting quality of RCTs of acupuncture for vascular dementia / 中国针灸

OBJECTIVE@#To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for vascular dementia.@*METHODS@#The RCTs of acupuncture for vascular dementia were systematically retrieved from the Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP and Wanfang databases from the date of establishment to October 31, 2018. The reporting quality of RCT was evaluated based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).@*RESULTS@#A total of 33 RCTs were included. According to the CONSORT statement, 12 items had a reporting rate of 0%, including important changes to methods after trial commencement, sample size, blind method, trial registry, etc.; 5 items had a reporting rate of below 10%, including trial design, type of randomization, random allocation sequence, randomization implementation and participant flow. The reporting rate was 36.36% for baseline data and 57.58% for randomization sequence generation. According to the STRICTA statement, the reporting rate was 21.21% for description of acupuncture depth, 60.61% for description of acupuncture response, 27.27% for description of additional intervention details and 0% for qualification of acupuncturists, respectively.@*CONCLUSION@#At present, the reporting quality of RCTs of acupuncture for vascular dementia is generally low. In the future, the RCTs of acupuncture for vascular dementia should be normatively reported according to the CONSORT statement and STRICTA statement.

Reporting quality of randomized controlled trials of acupuncture for cancer pain / 中国针灸

Based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), the reported quality of randomized controlled trials (RCTs) of acupuncture for cancer pain during last 10 years were evaluated. The RCTs of acupuncture for cancer pain were searched by computer. The English databases included PubMed and EMbase while the Chinese databases included CNKI, Wanfang, VIP and SinoMed. The publication date of the literature was from March 2009 to March 2019. As a result, 22 Chinese RCTs and 13 English RCTs were included. According to the CONSORT statement, among the Chinese studies, 1 RCT reported primary and secondary outcomes, 8 RCTs reported randomization, none of RCTs reported allocation concealment and blind method, and 4 RCTs reported baseline data; among the English studies, 8 RCTs reported primary and secondary outcomes, 8 RCTs reported randomization, 6 RCTs reported described allocation concealment, 7 RCTs reported blind method, and 13 RCTs reported baseline data. According to the STRICTA statement, among the Chinese studies, 17 RCTs reported the name of acupoints, 6 RCTs reported depth of insertion, 17 RCTs reported acupuncture response sought, and none of RCTs reported the qualifications of acupuncturists; among the English studies, 12 RCTs reported the name of acupoints, 7 RCTs reported depth of insertion, 8 RCTs reported acupuncture response sought, and 7 RCTs reported the qualifications of acupuncturists. The Chinese RCTs have more detailed description of acupuncture intervention and theory, but not enough attention is paid to methodological description such as randomization, blindness, data analysis. On the other hand, the English RCTs have better description of methodology, but the description of theory and details of acupuncture is relatively weak. It is concluded that more efforts were needed to further improve the clinical trial design according to the CONSORT statement and STRICTA statement to improve the quality of clinical evidence.

Quality assessment of reporting items in randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer / 国际生物医学工程杂志

Objective To evaluate the reporting item quality of randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. Methods The terms including Chinese medicine, Chinese herbal medicine, randomized controlled trials, and non-small cell lung cancer were searched in Chinese and English databases by computer systems to collect relevant literatures. Based on the CONSORT 2010 (consolidated standards of reporting trials 2010), the reporting item quality of the abstracts and main text in eligible papers was evaluated. Results Ninety-five eligible studies were identified from 692 potential eligible articles. None reported all of abstract and main text items in CONSORT 2010. Only 4.12％could be identified as the randomized trial in the title. More than 40％of reports showed the scientific background or rationale in the abstract but not in the main text. Three (3.16％) eligible reports defined the primary or secondary outcome measures. None reported complete information of subjects throughout the clinical trial process. Results A total of 95 eligible papers were collected, of which 0 papers reported complete abstracts and text entries according to the CONSORT. The titles of 4.12％papers were identified as randomized trials. More than 40％of the papers only reported the study purpose or hypothesis in the abstract. 3.16％of the papers reported primary and secondary efficacy index entries, and 0 papers reported complete information of subjects from enrollment to included data analysis sets. Conclusion There is a serious problem of items shortage in the literatures of randomized controlled clinical trials on Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. The randomized controlled clinical trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer should be reported based on the CONSORT to improve the quality of trials.

Investigation of human brucellosis diagnosis and report quality in medical institutions in key areas of Shanxi province / 中华流行病学杂志

Objective To evaluate the accuracy of human brucellosis diagnosis and reporting in medical institutions in Shanxi province, and understand the performance of clinical doctors to diagnose human brucellosis according to diagnostic criteria. Methods Field investigation was conducted in 6 medical institutions in the key areas of human brucellosis in Shanxi province. The diagnosis data of the reported brucellosis cases in 2015 were collected and reviewed retrospectively for the evaluation of the diagnosis accuracy with systematic sampling method. The database was established with Excel 2010 and the descriptive analysis and statistical test were conducted with software R 3.3.2. Results The diagnosis consistent rate of the 377 brucellosis cases reviewed was 70.8% (267/377), the diagnosis consistent rates in medical institutions at city-level and country-level were 77.0%(127/165) and 66.0%(140/212) respectively, the differences had significance (χ2=5.4, P=0.02). Among the reviewed cases, the diagnosis consistent rate of laboratory diagnosis and clinical diagnosis were 87.1%(256/294) and 13.3%(11/83) respectively, and the differences had significance (χ2=170.7, P<0.001) . Among the 21 investigated clinical doctors, the numbers of the doctors who correctly diagnosed the suspected cases, probable cases and lab-confirmed cases were only 3, 0 and 8 respectively. All of the clinical doctors knew that it is necessary to report the brucellosis cases within 24 hours after diagnosis. Conclusion The accuracy of human brucellosis diagnosis in key areas of human brucellosis in Shanxi was low, and the performance of the clinical doctors to diagnose human brucellosis according to diagnostic and case classification criteria was unsatisfied.

Investigation of human brucellosis diagnosis and report quality in medical institutions in key areas of Shanxi province / 中华流行病学杂志

Objective To evaluate the accuracy of human brucellosis diagnosis and reporting in medical institutions in Shanxi province, and understand the performance of clinical doctors to diagnose human brucellosis according to diagnostic criteria. Methods Field investigation was conducted in 6 medical institutions in the key areas of human brucellosis in Shanxi province. The diagnosis data of the reported brucellosis cases in 2015 were collected and reviewed retrospectively for the evaluation of the diagnosis accuracy with systematic sampling method. The database was established with Excel 2010 and the descriptive analysis and statistical test were conducted with software R 3.3.2. Results The diagnosis consistent rate of the 377 brucellosis cases reviewed was 70.8% (267/377), the diagnosis consistent rates in medical institutions at city-level and country-level were 77.0%(127/165) and 66.0%(140/212) respectively, the differences had significance (χ2=5.4, P=0.02). Among the reviewed cases, the diagnosis consistent rate of laboratory diagnosis and clinical diagnosis were 87.1%(256/294) and 13.3%(11/83) respectively, and the differences had significance (χ2=170.7, P<0.001) . Among the 21 investigated clinical doctors, the numbers of the doctors who correctly diagnosed the suspected cases, probable cases and lab-confirmed cases were only 3, 0 and 8 respectively. All of the clinical doctors knew that it is necessary to report the brucellosis cases within 24 hours after diagnosis. Conclusion The accuracy of human brucellosis diagnosis in key areas of human brucellosis in Shanxi was low, and the performance of the clinical doctors to diagnose human brucellosis according to diagnostic and case classification criteria was unsatisfied.

Assessment the methodological and ethical quality of randomized controlled trials of non-small cell lung cancer in China / 中华医学图书情报杂志

Objective To assess the methodological and ethical quality of randomized controlled trials (RCT) of non-small cell lung cancer ( NSCLC ) in China. Methods The methodological and ethical quality on RCT of NSCLC, covered in CBM, CNKI, VIP and Wanfang was assessed according to the Jadad Scale and Berdeu Scale respectively. Results The average methodological and ethical quality was 62. 24% according to the Jadad Scale and was 18. 79% according to the Berdeu Scale. Correlation analysis showed that the methodological quality was closely correlated with the ethical quality, except that of curative effect of invasive therapy (OR=1. 064, 95%CI:0. 832-1. 361, P>0. 05). Conclusion The methodological and ethical quality of RCT of NSCLC in China is low. The methodological quality is positively correlated with the ethical quality.