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 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.
ObjectivesUsing the ARRIVE guidelines (Animal Research Reporting: In Vivo Experiments Guidelines) to carry out a retrospective study of the reporting quality of animal studies published in Chinese journals.MethodsWe searched databases including CNKI, WanFang Data, VIP and CBM to July, 2018. Four reviewers independently screened literatures and extracted data. The ARRIVE guidelines were used to assess reporting quality and the comparative analysis based on different published time.ResultsA total of 4 342 studies were included. About the cited frequency, 73.03% studies were ≤5, and merely 29.04% studies were published in journals of CSCD. The assessment results showed that the number of reported items with "low risk" in the ARRIVE guidelines, which have 20 items, that meaning 39 sub items, more than half of sub items (51.28%, 20/39) rated as "low risk" had a compliance rate of less than 50%. Among them, 65.00% (13/20) of sub items had a lower rate of compliance with "low risk" than 10%.ConclusionThe reporting quality of domestic animal studies is generally low. The coincidence rate of domestic animal studies has been improved to some extent in most of items after the ARRIVE guidelines published, however, some items of methodology, results and conclusions had problems with insufficient reporting. Therefore, we suggest that it is necessary to popularize the ARRIVE guidelines, advocate more researchers following the ARRIVE guidelines and promote endorsement of the ARRIVE Guideline by Chinese Journals to improve the design, implementation and reporting of animal experiments, and ultimately enhance the quality of animal studies.
Objective To assess the reporting quality of systematic reviews/meta-analyses related to interventions published in Chinese Journal of Evidence-Based Medicine by PRISMA guidelines, and to analyze its influencing factors. Methods The systematic reviews/meta-analyses related to interventions were searched in the Chinese Journal of Evidence-Based Medicine from its inception to 2011. The quality of the included reviews was assessed in accordance with the PRISMA checklist. Based on the degree of conformity with each criterion of PRISMA, the reviews were scored as “1”, “0.5” or “0” orderly. The data were put into Excel, and the Meta-analyst software was used for statistical analysi. Results Among all literature in the volume 11 (95) of the Chinese Journal of Evidence-Based Medicine from 2001 to 2011, a total of 379 studies were included, and the number of publication showed a yearly rising trend. The PRISMA scale score ranged from 8.5 to 26 (X±SD) was 19.97±3.15. Among all studies, 25 (6.60%) scored 21-27 points, which were regarded as the complete reporting; 226 (59.63%) scored 15-21 points, regarded as relatively complete reporting; and 128 (33.77%) scored less than 15 points, regarded as serious lack of information. The results of stratified analysis showed that, both the issue of PRISMA and fund support could improve the reporting quality, with a significant difference (Plt;0.05); and authors more than 3, authors from universities, and authors from more than 2 institutions could improve the reporting quality, but without a significant difference (Pgt;0.05). Conclusion The overall reporting quality of systematic reviews/meta-analyses related to interventions published in the Chinese Journal of Evidence-Based Medicine is poor, and it is influenced by the factors of protocol and registration, risk of bias across studies, other analyses, and fund support, which have to be taken seriously. The reasonable utilization of the PRISMA checklist will improve the reporting quality of systematic reviews/meta-analyses.
ObjectiveTo investigate the application status of survival analysis in studies published in Chinese oncology journals, and assess their reporting quality and summarize the existing problems, so as to promote the application of survival analysis and reporting quality. MethodsStudies that used survival analysis were collected from 1 492 studies published in Chinese Journal of Oncology, Chinese Journal of Clinical Oncology, Chinese Journal of Radiation Oncology and Chinese Journal of Cancer Prevention and Treatment in 2013. The application status of survival analysis of included studies was analysed and their reporting quality was evaluated. ResultsA total of 242 survival analysis studies were included. Among them, the utilization rates of Kaplan-Meier method, life table method, log-rank test, Breslow test and Cox proportional hazards model were 91.74%, 3.72%, 78.51%, 0.41% and 46.28%, respectively. 112 studies did multivariate analysis through Cox proportional hazards model. A total of 396 end points and 10 different types of survival time were reported. Overall survival (OS) was reported in 233 studies (92.15%). Survival terms were defined to 158 end points (39.90%) of 103 studies (42.56%). The follow-up rates were mentioned in 155 studies (64.05%), of which 4 studies were under 80% and the lowest was 75.25%, 55 studies were 100%. The main problems of survival analysis studies published in Chinese journals were as follows:None of the studies which used Cox proportional hazards model reported the proportional hazards assumption. None of the studies used the method of parametric survival analysis. 130 studies (53.72%) did not use the method of multiple factor analysis. 139 studies (57.44%) did not define the survival terms. Only 11 of 100 studies which reported loss to follow-up had stated how to treat it in the analysis. None of the studies reported the methods of calculating sample size. None of the studies reported the censoring proportion. ConclusionThe methods of survival analysis are used in a low rate in studies published in Chinese oncology journals, and the overall reporting quality of survival analyses is poor. So the reporting guideline of survival analysis should be developed and the authors should be encouraged to cooperate with professional statisticians, in order to improve the design, analysis and reporting quality of survival analysis studies.
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.
N-of-1 trials are prospective clinical randomized cross-over controlled trials with multiple rounds of trial phase alternation designed with regard to a single patient. N-of-1 trials can provide clinical decision-makers with high-level evidence of the comparison of effect of intervention measures. Recently, an international team composed of many scholars published a SPIRIT extension for N-of-1 trials list (SPENT 2019) on the BMJ, with the purposes of clarifying the content design and improving the integrity and transparency of N-of-1 trial protocols. This article showed a detailed interpretation of the 14 main extension sub-items of the SPENT 2019 list with specific cases, aiming to further standardize the publication of domestic N-of-1 trials.
Objective To evaluate the reporting quality of randomized controlled trials (RCTs) in seven military medical journals. Methods Seven journals in 2007, including Medical Journal of Chinese People’s Liberation Army, Journal of South Medical University, Journal of Second Military Medical University, Journal of Third Military Medical University, Journal of Fourth Military Medical University, Bulletin of the Academy of Military of Medical Sciences and Academic Journal of PLA Postgraduate Medical School, were handsearched. We identified RCTs labeled “random” and assessed the quality of these reports using the Consolidated Standards for Reporting of Trials (CONSORT) statement. Results We identified 99 RCTs, but found an incorrect randomized method was used in 6 RCTs. According to the items in the CONSORT statement in 93 RCTs, 62 (66.7%) RCTs described baseline demographic and clinical characteristics in each group. Sixteen (17.2%) RCTs mentioned the method of random sequence generation, with 5 (5.4%) using a computer allocation. Only 1 RCT had adequate allocation concealment. Only 9 (9.7%) RCTs used blinding, with 2 mentioning blinding, 1 using single blinding and 6 described as double-blind (2 were correct). Zero (0%) reported the sample size calculation and 1 RCT reported the intention-to-treat (ITT) analysis. Conclusion The reporting quality of RCTs in seven journals is poor. The CONSORT statement should be used to standardize the reporting of RCTs.
ObjectiveTo analyze the reporting and methodological quality of tranexamic acid meta-analyses published in Chinese journals. MethodsThe CNKI, WanFang Data, and CBM databases were electronically searched for meta-analyses of tranexamic acid from inception to August 12th, 2021. Two reviewers independently screened literature, extracted data, and used AMSTAR 2 and PRISMA 2009 to assess the methodological and reporting quality of publications. ResultsA total of 68 meta-analyses were included. The identified meta-analyses required improvement for items 2, 3, 4, 7, 8, 10, 12, 15, and 16 in the AMSTAR 2, and items 2, 5, 8, 12, 15, 17, 22, 24, and 27 in the PRISMA 2009 assessments, respectively. The methodological and reporting quality scores were positively correlated (rs=0.36, P=0.002). Linear regression analysis identified the mentioning of PRISMA and funding support as the independent factors potentially affecting the reporting quality score (P<0.05). ConclusionsBoth the methodological and reporting quality of the tranexamic acid meta-analyses published in Chinese journals require improvement.
Objective To investigate the health technology assessment reports, analyze publication characteristics and report quality, and explore hot topics in health technology assessment. Methods Web of Science and CNKI databases were searched to collect complete health technology assessment reports from inception to January 2023. SPSS 26.0 software was used to analyze the publication journals, countries, number of authors, assessment types and assessment contents of the assessment reports. The report quality was assessed based on International Network of Agencies for Health Technology Assessment (INAHTA) report criteria (2007 edition). VOSviewer 1.6.11 was used to analyze keywords clustering. Results A total of 216 papers were included, with 158 published by Chinese authors, and a rapid growth trend in the number of reports over past four years. The rate of reports on health technology social adaptability assessment was only 17.13%. Among the Chinese reports, 25 were general health technology assessments, 35 were rapid assessments, and 3 were mini assessments. Among the English reports, 4 were rapid assessments, and 54 were regular healthcare technology assessments. For the 14 items in the INAHTA reporting criteria, the reporting rates were high for the brief summary (98.61%), problem description (94.91%), and results discussion entries (97.69%). However, the reporting rates were low for criteria such as personnel responsibilities, conflict of interest statements, and peer review statements, at 31.94%, 19.44%, and 3.24% respectively. English literature generally exhibited higher report quality. Conclusion In recent years, the volume of health technology assessment reports in China has been increasing, with developments in assessment types and application fields. However, there are also problems with standardization of reporting.