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.
Stepped wedge cluster randomized trials (SW-CRT) is a kind of cluster randomized controlled trial mainly applied in the field of public health policy that has emerged in recent years, which has gradually attracted the attention of workers in the field of health and wellness. At present, this trial method is not widely used at home and abroad, and there are various ways of sample size calculation and statistical analysis. This paper describes the principles, categories, and differences between SW-CRT and traditional randomized controlled trials, and outlines sample size calculation and statistical analysis methods. In general, SW-CRT is characterized by clustering, cross-design, and measurement of results at multiple time points. In terms of sample size calculation, it is necessary to distinguish between clusters with the same and different sizes, and commonly used sample size calculation procedures can be implemented in Stata, R, and SAS software, as well as in fixed online websites, including the "Steppedwedge" program, the "swCRTdesign" program, the "Swdpwr" program, the "CRTpowerdist" program, and the "Shiny CRT Calculator" tool and so on. Based on the design characteristics of SW-CRT, the researcher should also consider the confounding factors of time effects and repeated measurements of result. Therefore, the statistical analysis methods are often based on generalized linear mixed model (GLMM) and generalized estimating equations (GEE). However, most of the above models have been proposed based on cross-sectional studies, there is a lack of statistical methods for queue design and SW-CRT with transitional period now, and more comprehensive methodological exploration is still needed in the future.
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.
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.