Objective To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes. Methods We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004. Results A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow. Conclusion The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.
ObjectiveTo evaluate the reporting quality of systematic reviews (SRs)/meta-analyses on acupuncture focusing on literature screening results and explore the influencing factors of the complete reporting.MethodsPubMed, EMbase, CNKI, WanFang Data, and VIP databases were searched to collect SRs/meta-analyses on acupuncture from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and evaluated the reporting quality of literature screening results of SRs/meta-analyses on acupuncture based on PRISMA statement. Logistic regression model analysis was applied to explore the influencing factors of the complete reporting rate of literature screening results. Statistical analysis was performed by using Excel 2016 and SPSS 16.0 software.ResultsA total of 1 227 SRs/meta-analyses were included. Only 62.3% SRs fully reported the four parts of literature screening results. The parts with a low reporting rate included the number of studies assessed for eligibility (73.2%) and the reasons for exclusions at each stage (67.0%). And the reporting rate of the literature screening flowchart was also low (63.6%). The reporting rate of literature screening results in Chinese SRs was lower than that in English SRs, and there was significantly statistical difference (P<0.001). Multivariate logistic regression analysis showed that the type of published journal, publication year, pages of article and the number of searched databases were correlated with the complete reporting rate of literature screening results (P<0.001).ConclusionsThe complete reporting rate of the literature screening results of SRs on acupuncture is low, especially in Chinese SRs. The complete reporting rate of literature screening results is significantly higher for SRs published after PRISMA statement, in SCI journals, with longer length and more searched databases.
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.
Objective To assess the methodological quality and reporting quality of meta-analysis published in Chinese Acupuncture & Moxibustion. Methods We searched CNKI database to collect meta-analysis published in Chinese Acupuncture & Moxibustion up to 2015. Methodological quality assessment was carried out using AMSTAR tool, and quality assessment was carried out by PRISMA checklist. Data analysis was performed by using SPSS 19.0 software. Results A total of 31 meta-analyses were enrolled. Among all the 31 meta-analyses, the first authors came from 19 institutions, and 21 meta-analysis were supported by fundings. All meta-analyses were about the evaluations of acupuncture intervention, involving 10 disease systems (ICD-10) and sub-health. The mean score of the methodological assessment was 7.42±1.13. In addition, the mean score of reporting quality was 18.79±2.04. Conclusion The meta-analyses published in Chinese Acupuncture & Moxibustion have high quality on methodology as well as reporting. Due to the limited quality and quantity of included studies, the above results are needed to be further assessed by more studies.
ObjectivesTo analyze the current methodological and reporting quality of both domestic and overseas clinical practice guidelines on acupuncture, and to provide reference for the development of high quality acupuncture clinical practice guidelines.MethodsGIN, NICE, AHRQ, PubMed, EMbase, AMED, CINAHL, WanFang Data, CNKI, VIP and CBM databases were electronically searched to collect domestic and overseas clinical practice guidelines on acupuncture from inception to September, 2018. Two reviewers independently screened literature, extracted data and evaluated the methodological and reporting quality by using AGREE Ⅱ and RIGHT tools.ResultsA total of 23 acupuncture clinical practice guidelines were included, in which three were developed by foreign institutions, and the remaining 20 guidelines were jointly developed by WHO Western Pacific Region and China Institute of Acupuncture and Moxibustion. Three foreign and two domestic guidelines were selected for evaluation. The AGREE Ⅱ evaluation showed that the domestic guidelines have higher scores in terms of " scope and purpose”, " stakeholder involvement”, " rigor of development”, " applicability” and " clarity of presentation”, while only " editorial independence” is lower. The overall recommendation is stronger than the foreign guidelines. The RIGHT evaluation showed that for three foreign guidelines, the " reported” items accounted for 52.38%, " unreported” items accounted for 38.09%, " partly reported” items accounted for 6.66%%; however, for domestic guidelines, the " reported” accounted for 45.71%, " unreported” items accounted for 40%, and " partly reported” items accounted for 14.28% respectively. Overall, the difference is not significant (SD<10%). Due to the specificity of acupuncture interventions, the use of AGREEⅡ and RIGHT to evaluate acupuncture clinical practice guidelines still had barriers to some extend on its applicability.ConclusionThe methodological and reporting quality of acupuncture clinical practice guidelines are relatively low. It is urgent to further improve the methodological level and reporting standards of the guidelines, and to develop evaluation tools for the acupuncture field guidelines.
Objective To evaluate reporting and methodological quality of systematic reviews or meta-analyses in nursing field in China. Methods CNKI database was searched for systematic reviews or meta-analyses in nursing field from the establishment date to December 2011. Two reviewers independently identified the literature according to inclusion and exclusion criteria, and then extracted the data using Excel software. The PRISMA and AMSTAR checklists were used to assess reporting characteristics and methodological quality, respectively. Results A total of 63 systematic reviews or meta-analyses involving 21 systematic reviews and 42 meta-analyses were identified. These articles were published on 13 journals such as The Chinese Nursing Research, the Chinese Journal of Nursing, and the Chinese Journal of Evidence-Based Medicine. The deficiencies of methodological quality mainly contained literature search, heterogeneity handling, recognition and assessment of publication bias. In addition, the deficiencies of reporting characteristics were reflected on incomplete reporting of literature search, quality assessment, risk of bias and results (some studies lacked forest plot, estimated value of pooled results, 95%CI or heterogeneity). Conclusion As a whole, the included reviews and meta-analyses have more or less flaws with regard to the quality of reporting and methodology based on the PRISMA and AMSTAR checklists. Focusing on the improvement of reporting and methodological quality of systematic review or meta-analysis in nursing field in China is urgently needed in order to increase the value of these studies.
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.
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.
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.