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.
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.
Patient reported outcome measures (PROM) are widely used in clinical research and practice. To aid the interpretation of PROM, researchers have proposed the minimal important difference (MID), the smallest change or difference that patients perceive as important. However, the estimation methods of MID are numerous and inconsistent, which brings difficulties to selecting the optimal MID estimate to interpret PROM results. To address this issue, a research team from McMaster University in Canada has proposed an approach for selecting the optimal MID. This method includes three core steps: evaluating the credibility of MID estimates, assessing the consistency among credible MID estimates, and selecting the optimal value based on contextual factors. The credibility evaluation instrument for anchor-based MID examines five core criteria, including the data sources of PROM and anchor, the interpretability of anchor, the correlation between anchor and PROM, the precision of MID estimates, and the judgment of anchor thresholds. When there are multiple credible MID estimates, the optimal MID estimate is selected by evaluating the consistency among the estimates and considering contextual factors that affect the variability among the estimates, such as the type of intervention, follow-up time, and disease severity. In addition, the team provided recommendations to improve the reporting quality of MID studies. This article provides a detailed introduction and interpretation of these developments, aiming to enhance researchers' and clinicians' understanding and application of MID, thereby supporting clinical research and healthcare decision-making.
ObjectivesTo evaluate the reporting quality of individual/focus group interviews published in nursing journals included in the Chinese science citation database (CSCD).MethodsCSCD database was electronically searched to collect qualitative studies published in nursing journals included in CSCD from January 2016 to December 2018. Two researchers independently screened literatures, extracted data, and assessed the quality of included studies by COREQ guidelines, SPSS 25.0 software was then used for statistical analysis.ResultsA total of 223 qualitative researches were included. The results of COREQ evaluation showed that full report rate of 43.8% (14/32) studies were less than 50%, 78.6% (11/14) were less than 20%, and the full report rate of item 4 was even 0%. There were no significant differences between different total cites and the availability of funding in COREQ guidelines.ConclusionThe reporting quality of the qualitative researches published in the four nursing journals included in the CSCD requires further improvement. Therefore, we suggest that domestic nursing journals should introduce COREQ guidelines in contribution and strictly implement it in editorial review and peer review.
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 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 provide references for scientific selection of different tools/guidelines by comprehensively collecting international and national tools/guidelines for assessing reporting quality and methodological quality of animal experiments, comparing them in development foundation, application scope, and aims. MethodsPubMed, EMbase, CNKI, VIP and WanFang Data were searched up to July 2014, to collect tools/guidelines for reporting quality and methodological quality of primary animal experiments. We extracted data from included guidelines/tools, including the number of items, development foundation, disease models, application scope, and assessment focus. Then descriptive analysis was conducted. ResultsA total of 32 studies were finally included, of which, 6 were for reporting quality and 26 for methodological quality. The item number of the included tools/guidelines ranged from 2 to 54. Seven tools/guidelines applied score system to assess methodological quality. Fifteen tools/guidelines were designed for specific disease models. Nineteen tools/guidelines were suitable for assessing preclinical drug studies, and 4 were designed to assess environmental toxicology research. ConclusionAlthough many tools for assessing methodological quality of animal experiments have been published so far, SYRCLE's risk of bias tool is the only one that is used to assess internal validity of animal experiments at present. Besides, although the ARRIVE guidelines and GSPC are not official mandatory reporting criteria at present, they are acknowledged by many researchers as efficient reference checklists and writing guidelines for writing and publishing animal experiments. We recommend the application of SYRCLE's risk of bias tool, ARRIVE guidelines and GSPC, in order to efficiently improve research design, implementation, reporting, differentiation, and evaluation of animal experiments, promote the development of animal experiments, and to promote full application and translation of scientific achievements.
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.
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
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.