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 evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for acute ischemic stroke. Methods Six databases including The Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2005), MEDLINE (1966 to December 2005), EMbase (1984 to December 2005), China National Knowledge Infrastructure (CNKI, 1994 to December 2005), China Biomedicine Database disc (CBMdisc, 1980 to December 2005), VIP (a full text issues database of China, 1989 to December 2005) were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).Results In regard to the items in the CONSORT statement, 54 (73%) RCTs described baseline demographic and clinical characteristics in each group. Twenty-six (35%) mentioned the method of generating the random sequence, with 4 (5%) using a computer allocation. Only 6 (8%) RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 (11%) RCTs used blinding, including 5 described as double-blind. Four (5%) RCTs reported the sample size calculation and 5 (7%) RCTs reported that an intention-to-treat (ITT) analysis. In regard to the items in STRICTA , only 4 (5%) RCTs reported the numbers of needles inserted. In 35 (47%) RCTs the needle type was reported, but only 26 (35%) mentioned the depths of insertion. Only 1 (1%) RCT mentioned the length of clinical experience and 6 (8%) RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training.Conclusion The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.
ObjectivesTo assess the methodological and reporting quality of surgical meta-analyses published in English in 2014.MethodsAll meta-analyses investigating surgical procedures published in 2014 were selected from PubMed and EMbase. The characteristics of these meta-analyses were collected, and their reporting and methodological quality were assessed by the PRISMA and AMSTAR, respectively. Independent predictive factors associated with these two qualities were evaluated by univariate and multivariate analyses.ResultsA total of 197 meta-analyses covering 10 surgical subspecialties were included. The mean PRISMA and AMSTAR score (by items) were 22.2±2.4 and 7.8±1.2, respectively, and a positive linear correlation was found between them with a R2 of 0.754. Those meta-analyses conducted by the first authors who had previously published meta-analysis was significantly higher in reporting and methodological quality than those who had not (P<0.001). Meanwhile, there were also significant differences in these reporting (P<0.001) and methodological (P<0.001) quality between studies published in Q1 ranked journals and (Q2+Q3) ranked jounals. On multivariate analyses, region of origin (non-Asiavs. Asia), publishing experience of first authors (ever vs. never), rank of publishing journals (Q1 vs. Q2+Q3), and preregistration (presence vs. absence) were associated with better reporting and methodologic quality, independently.ConclusionThe reporting and methodological quality of current surgical meta-analyses remained suboptimal, and first authors' experience and ranking of publishing journals were independently associated with both qualities. Preregistration may be an effective measure to improve the quality of meta-analysis, which deserves more attention from future meta-analysis reviewers.
ObjectiveTo analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials, and to analyze the progress and shortcomings of health Qigong-related clinical trials.MethodsChinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15st, 2020. Characteristics of trials were analyzed in the aspects of basic information, funding source, study content and more. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).ResultsA total of 121 registered clinical trials were included. The annual registration quantity has been increasing with a peak (33.06%) reached in 2020. Among the registered trials, Baduanjin exercise- related studies accounted for the highest proportion (65.29%). The quantity of studies registered in Shanghai accounted for the most (29.75%). The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (5.79%). 50.83% funds in trials were originated from universities and hospitals. Type 2 diabetes, and chronic obstructive pulmonary disease were the most studied diseases in the registered trials. 90.08% trials were designed as randomised parallel control studies, and the sample sizes of trials were concentrated between 30 and 100 (71.07%), and the age of the subjects was distributed over 40 years old (46.15%). The average quality of registration completion of the two registries was 87.44%.ConclusionsAt present, the general trend of health Qigong clinical research is positive. However, these trials contain unbalanced attributes such as the research type of health Qigong, distribution of registration area and organization, allocation of funds, and age composition of subjects. The design of clinical trials and registration details are needed to be improved.
ObjectivesTo assess the methodological quality and reporting quality of meta-analysis published on The Chinese Journal of Nursing.MethodsCNKI and WanFang Data databases were electronically searched to collect meta-analysis which published on The Chinese Journal of Nursing from inception to December 2017. Two reviewers independently screened literature, extracted data and assessed the methodological quality and the reporting quality by AMSTAR scale and PRISMA statement. Statistical analysis was then performed by using SPSS 19.0 software.ResultsA total of 53 meta-analyses were included, which involved 7 disease systems and sub-health status. The mean score of the methodological assessment by AMSTAR was 7.75±1.32, including 9 high-quality papers (17.0%), 41 middle-quality papers (77.4%), and 3 low-quality papers (5.6%). The mean score of the reporting quality assessment by PRISMA was 22.5±3.08, including 39 relatively complete papers (73.6%), 11 papers with certain defects (20.8%), and 3 papers with serious defects (5.6%).ConclusionsThe methodological and reporting quality of meta-analysis published on The Chinese Journal of Nursing deserves further improvement.
Objective While reporting of adverse drug reactions (ADR) and adverse drug events (AE) following Chinese medicine injection (CMI) is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of ADR/AE was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (CJN) (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were 7 reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned ‘adverse effect,’ ‘safety’ or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, while 128 cases (56.89%) in Type II papers and Fourteen (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CMI procedure, such as the drug company, product serial number, or the drug’s validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized. Much fundamental information of ADR/AE following CMI is therefore missing. A standard reporting format for ADR should be developed, and should include the following: 1) a title mentioning adverse effects and safety; 2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; 3) demographic characteristic of the patients (gender, age, etc.); 4) clinical characteristics of patients (disease, syndrome, etc); 5) allergic history of patients; 6) diagnosis and syndrome based on Chinese medicine theory; 7) detailed information about the Chinese materia medica intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); 8) concomitant drug use; 9) time and symptoms of ADR/AE; 10) type and grading of ADR/AE; 11) physiological systems affected by ADR/AE; 12) specific treatment and prognosis for ADR/AE; 13) evidence of the cause and effect of ADR/AE; 14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.
ObjectivesTo evaluate the methodology quality and report quality of the published systematic reviews/meta-analyses (SRs/MAs) of pediatric tuina domestically and abroad.MethodsCBM, VIP, CNKI, WanFang Data, PubMed, EMbase, and The Cochrane Library were electronically searched to collect published pediatric tuina SRs/MAs from inception to December 10th, 2018. The SRs/MAs which includes scale evaluation used AMSTAR2 and the PRISMA report quality evaluation tool to systematically review methodology, adopts Excel to carry out data collation and statistical analysis. ResultsA total of 18 studies (14 in Chinese and 4 in English) on the SRs/MAs of pediatric tuina were finally included. In terms of methodological quality, 6 studies were of low quality and 12 studies were of very low quality. All studies did not explain the reasons for adopting a particular research design type, and few of them explained the pre-plan, exclusion list, reasons and funding. In terms of report quality, 7 studies were relatively complete, 10 studies had certain defects and one study had serious defects. The existing problems were program and registration, comprehensive retrieval, information sources, financial support and so on. ConclusionsSRs/MAs of pediatric tuina have different degrees of issues in terms of methodological quality and report quality which still require further improvement and continuous strengthening.
Objective To evaluate the methodological and reporting quality of systematic reviews/meta-analyses related to the efficacy and safety of corticosteroid-assisted treatment for severe pneumonia. Methods PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, WanFang Data and VIP databases were searched by computer, and the systematic reviews/meta-analyses of corticosteroid hormone as an auxiliary means for the treatment of severe pneumonia which were published from establishment of the databases to October 25th, 2018 were searched. A Measurement Tool to Assess Systematic Review-2 (AMSTAR-2) was used to assess the methodological quality of the included studies, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used to evaluate the quality of literature reports. Results A total of 16 systematic reviews/meta-analyses were included, all of which were non-Cochrane systematic reviews. In terms of methodological quality assessed by AMSTAR-2, there was no plan in all studies; only one study explained the reasons for inclusion in the study type; eight studies did not describe the dose and follow-up time of the intervention/control measures in detail; three studies did not indicate the evaluation tools and did not describe the risk bias; six studies did not explicitly examine publication bias. In terms of reporting quality assessed by PRISMA, all studies had no pre-registered study protocol or registration number; thirteen studies did not describe the specific amount of articles retrieved from each database; three studies did not present their retrieval strategies or excluded reasons in detail; no funding sources were identified in included studies; eight studies reported both whether the study was funded and whether there was a conflict of interest. Conclusions At present, there are many systematic review/meta-analysis studies on the efficacy and safety of corticosteroid-assisted treatment for severe pneumonia, and the overall quality of the study has been gradually improved. However, the common problems in the study are relatively prominent. The follow-up period and dose of intervention in the study of severe pneumonia are different, so the baseline is difficult to be unified. Suggestions: strengthening the training of researchers, standardize the research process, and report articles in strict accordance with the PRISMA statement; subgroup analysis being conducted according to the dose and duration of the hormone.
ObjectivesTo evaluate the reporting quality of clinical practice guidelines published in Chinese journals in 2017.MethodsCBM, CNKI and WanFang Data databases were searched for articles published in 2017. Two reviewers independently screened literature, extracted data, and evaluated the reporting quality of clinical practice guidelines using the Reporting Items for Practice Guidelines in Healthcare (RIGHT).ResultsOne hundred and seven clinical practice guidelines were included and a total reporting rate of 34.8%±0.1% in RIGHT. Among the seven domains of RIGHT, field on basic information had the highest reporting rate (56.8%) and fields on review and quality assurance had the lowest reporting rate (9.3%).The average reporting rate of RIGHT items of Chinese Science Citation Database (CSCD) articles was lower than non-CSCD [MD=−0.73, 95%CI (−0.78, −0.68)] articles. The average reporting rates of RIGHT items differed between Chinese Medical Association (CMA) journal articles and non-CMA journal articles [MD=2.30, 95%CI (2.26, 2.34)]. The average reporting rates of RIGHT items was lower in guidelines established by associations or institutes [MD=−3.78, 95%CI (−3.83, −3.73)], and was higher reported in Chinese medicine guidelines [MD=21.94, 95%CI (21.91, 21.97)].ConclusionsThe reporting quality of clinical practice guidelines published in journals of mainland China in 2017 is low in general, especially in fields such as review and quality assurance, funding and declaration and management of interests and other information. To improve this phenomena, it is suggested that guideline developers report the guidelines rigorously with international standard.
ObjectivesTo assess the characteristics, methodological and reporting qualities of systematic reviews on community interventions in China.MethodsThe Cochrane Library, PubMed, EMbase, Web of Science, CNKI, VIP, WanFang Data and CBM databases were searched for studies of community interventions from inception to August 2017. Two reviewers independently screened literature, extracted data and assessed the methodological and reporting quality by AMSTAR tool and PRISMA checklist. Data analysis was performed by SPSS 20.0 software.ResultsA total of 18 systematic reviews of community interventions were included. The average AMSTAR score was 4.67±1.68, and all studies did not provide the list of included and excluded studies or a statement on conflict of interests. The average PRISMA score was 16.42±3.65, and over 50.0% of the included systematic reviews did not perform protocol and registration, search, additional analyses, risk of bias of included studies and funding.ConclusionsThe evidence shows that the reporting and methodological quality of meta-analyses of community interventions in China is insufficient. The combination of results, quality of individual research and the evaluation of publication bias should be paid more attention to improve methodological quality. The reporting of meta-analyses of community interventions in China should follow the PRISMA checklist.