a b s t r a c tSince its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcriptionpolymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital

These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

This systematic review was performed to determine the clinical efficacy and safety of total flavonoids from Rhizoma Drynariae (TFRD) for osteoporotic fractures and to provide clear evidence for clinical practice. Eight databases were searched to identify relevant randomized controlled trials (RCTs) until December 2016. Six RCTs involving 846 patients were included. The primary outcomes included fracture recurrence and death. Meta-analysis showed that both the combination therapy and TFRD alone were better than conventional treatments in improving bone mineral density (BMD) value (weighted mean difference [WMD] =3.68, 95% confidence interval [CI]: 0.01 to 0.04, P=0.0002), (WMD =0.14; 95% CI: 0.11 to 0.16; P<0.00001), respectively, and enhancing therapeutic effect (OR =0.25; 95% CI: 0.12 to 0.51; P=0.0002). Thirty-three patients experienced adverse drug reactions (ADRs), none of the ADRs were severe and all were resolved after symptomatic treatments. Gastrointestinal symptoms were the most common ADRs in the usage of TFRD. Overall, the effect of TFRD on osteoporotic fractures was supported by improving BMD and therapeutic effect. Due to the methodological drawbacks of the included studies, the conclusions should be treated with caution for future research. Registration number: CRD42017052797.

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BackgroundShenmai injection (SM), as a traditional Chinese medicine injection, is widely used for chronic cor pulmonale heart failure in mainland China. It is essential to systematically assess the efficacy and safety of SM as an adjuvant treatment for chronic cor pulmonale heart failure.MethodsEight English and Chinese electronic databases were searched, from inception to December 2014, to identify randomized controlled trials (RCTs) of SM for chronic cor pulmonale heart failure. The Cochrane Risk of Bias tool was used to evaluate the methodological quality of eligible studies. Meta-analysis was performed by Review Manager 5.2.ResultsTwenty-seven RCTs with 2045 participants were identified. The methodological quality of the included studies was generally low. Only one trial reported data on death. None of the included trials reported quality of life. The meta-analysis indicated that compared to conventional treatment, the combination of SM and conventional treatment was more effective in terms of the New York Heart Association classification (RR, 1.26; 95 % CI, 1.20–1.32; P < 0.00001), Left Ventricular Ejection Fraction (MD, 11.33; 95 % CI, 8.59–14.07; p < 0.00001), partial pressure of oxygen (MD, 1.00; 95 % CI, 0.64–1.36; P < 0.00001) and partial pressure of carbon dioxide (MD, 0.83; 95 % CI, 0.58–1.08; p < 0.00001). In addition, two trials reported that SM plus conventional treatment was superior to the conventional treatment alone to reduce B-type natriuretic peptide. No serious adverse drug events or reactions were reported.ConclusionsSM plus conventional treatment appeared to be effective and relatively safe for chronic cor pulmonale heart failure. However, due to the generally low methodological quality and small sample size, this review didn’t find evidence to support routine use of SM as an adjuvant treatment for chronic cor pulmonale heart failure.Electronic supplementary materialThe online version of this article (doi:10.1186/s12906-015-0939-2) contains supplementary material, which is available to authorized users.