Standard of care for COVID-19 in randomized clinical trials registered in trial registries and published in preprint servers and scholarly journals: a cross-sectional study.

BACKGROUND: The concept of standard of care (SoC) treatment is commonly utilized in clinical trials. However, in a setting of an emergent disease, such as COVID-19, where there is no established effective treatment, it is unclear what the investigators considered as the SoC in early clinical trials. The aim of this study was to analyze and classify SoC reported in randomized controlled trial (RCT) registrations and RCTs published in scholarly journals and on preprint servers about treatment interventions for COVID-19. METHODS: We conducted a cross-sectional study. We included RCTs registered in a trial registry, and/or published in a scholarly journal, and/or published on preprint servers medRxiv and bioRxiv (any phase; any recruitment status; any language) that aim to compare treatment interventions related to COVID-19 and SoC, available from January 1, 2020, to October 8, 2020. Studies using "standard" treatment were eligible for inclusion if they reported they used standard, usual, conventional, or routine treatment. When we found such multiple reports of an RCT, we treated those multiple sources as one unit of analysis. RESULTS: Among 737 unique trials included in the analysis, 152 (21%) reported that SoC was proposed by the institutional or national authority. There were 129 (18%) trials that reported component(s) of SoC; the remaining trials simply reported that they used SoC, with no further detail. Among those 129 trials, the number of components of SoC ranged from 1 to 10. The most commonly used groups of interventions in the SoC were antiparasitics (62% of the trials), antivirals (57%), antibiotics (31%), oxygen (17%), antithrombotics/anticoagulants (14%), vitamins (13%), immunomodulatory agents (13%), corticosteroids (12%), analgesics/antipyretics (12%). Various combinations of those interventions were used in the SoC, with up to 7 different types of interventions combined. Posology, timing, and method of administration were frequently not reported for SoC components. CONCLUSION: Most RCTs (82%) about treatment for COVID-19 that were registered or published in the first 9 months of the pandemic did not describe the "standard of care" they used. Many of those interventions have, by now, been shown as ineffective or even detrimental.

Reasons and factors associated with inconclusiveness of systematic reviews about interventions for neuropathic pain.

Aim: Systematic reviews (SRs) are frequently inconclusive. The aim of this study was to analyze factors associated with conclusiveness of SRs about efficacy and safety of interventions for neuropathic pain (NeuP). Materials & methods: The study protocol was registered in the PROSPERO database (No. CRD42015025831). Five electronic databases (Medical Literature Analysis and Retrieval System Online, Cochrane Database of Systematic Reviews, Cumulative Index for Nursing and Allied Health Literature, Database of Abstracts of Reviews of Effects and Psychological Information Database) were searched until July 2018 for SRs about NeuP management. Conclusion statements for efficacy and safety, and characteristics of SRs were analyzed. Conclusiveness was defined as explicit statement by the SR authors that one intervention is better/similar to the other in terms of efficacy and safety. Methodological quality of SRs was assessed with the AMSTAR (A MeaSurement Tool to Assess systematic Reviews) tool. Results: Of 160 SRs, 37 (23%) were conclusive for efficacy and/or safety. In the SRs, conclusions about safety were missing in half of the analyzed abstracts, and a third of the full texts. Conclusive SRs included significantly more trials and participants, searched more databases, had more authors, conducted meta-analysis, analyzed quality of evidence, and had lower methodological quality than inconclusive SRs. The most common reasons for the lack of conclusiveness indicated by the SR authors were the small number of participants and trials, and the high heterogeneity of included studies. Conclusion: Most SRs about NeuP treatment were inconclusive. Sources of inconclusiveness of NeuP reviews need to be further studied, and SR authors need to provide conclusions about both safety and efficacy of interventions.

Association between child/adolescent overweight/obesity and conduct disorder: A systematic review and meta-analysis.

BACKGROUND: Research findings of the association and its pattern between obesity and psychiatric/psychological comorbidities are not consistent across the types of comorbidities or the study subgroups. OBJECTIVES: We aimed to perform meta-analysis of cross-sectional studies and longitudinal studies analysing obesity as a risk factor for conduct disorder in order to assess the association between child/adolescent overweight/obesity and conduct disorder. METHODS: Systematic literature search, study selection and data extraction were performed independently by the two authors. Data were analysed by Comprehensive Meta-analysis software. RESULTS: Analysis of 13 high-quality cross-sectional studies including 79 027 children and adolescents indicated a significant association between overweight/obesity and conduct disorder among children and adolescents (OR 1.32 [95% CI, 1.18-1.49], I2 = 86.68), with no publication bias. Subgroup analyses yielded a significant difference (P < .01) between boys and girls. Analysis of four low- to moderate-quality longitudinal studies (OR 1.11 [95% CI, 0.89-1.38], I2 = 57.69) showed no prospective association between overweight/obesity and conduct disorder. Subgroup analysis according to gender revealed a significant positive association for boys and negative association for girls. CONCLUSIONS: Based on the high-quality cross-sectional data, overweight and obesity are associated with conduct disorder among children and adolescents, affecting boys more frequently than girls. Results of the longitudinal analysis indicated possible association in boys, while girls seem to be protected from conduct disorder. However, these results are very unreliable, indicating the need of well-designed longitudinal studies to elucidate the pattern of association between these disorders.

Pain associated with psoriasis: systematic scoping review protocol.

INTRODUCTION: Psoriasis is a common chronic skin inflammatory disease. Its presentation, apart from affected skin areas, involves other unpleasant symptoms, such as pain. Pain deteriorates the patient's quality of life, impairing their daily behaviour and functioning. Therefore, the alleviation of pain in patients with psoriasis should be one of the most desired outcomes of successful treatment. The aim of this study is to summarise available evidence about pain in patients with psoriasis using systematic scoping review methodology in order to map the relevant literature. METHODS AND ANALYSES: Our scoping systematic review will provide evidence synthesis of the literature, both quantitative and qualitative, about the pain associated with psoriasis, including pain associated with psoriatic arthritis. Any types of studies will be eligible for inclusion, and we will not have any time, language or publication status restrictions. We will search MEDLINE, Embase and PsycINFO via OVID, as well as Cochrane Central Register of Clinical Trials, Cochrane Database of Systematic Reviews via Cochrane Library, CINAHL via EBSCO, OpenGrey and ProQuest Dissertations and Theses Global. All databases will be searched from the date of their inception. Retrieved bibliographic records and potentially relevant full texts will be screened by two authors independently. Two researchers will extract data independently. Any discrepancies will be resolved via discussion or consultation of the third author, if necessary. To appraise studies, we will use a Mixed Methods Appraisal Tool, AMSTAR 2, Cochrane risk of bias tool and ROBINS. Our findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. ETHICS AND DISSEMINATION: The proposed study will not be conducted with human participants. We will only use published data and therefore ethics approval is not required. Our findings will be disseminated via peer-reviewed manuscript and conference reports.

Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19.

BACKGROUND: The research community reacted rapidly to the emergence of COVID-19. We aimed to assess characteristics of journal articles, preprint articles, and registered trial protocols about COVID-19 and its causal agent SARS-CoV-2. METHODS: We analyzed characteristics of journal articles with original data indexed by March 19, 2020, in World Health Organization (WHO) COVID-19 collection, articles published on preprint servers medRxiv and bioRxiv by April 3, 2010. Additionally, we assessed characteristics of clinical trials indexed in the WHO International Clinical Trials Registry Platform (WHO ICTRP) by April 7, 2020. RESULTS: Among the first 2118 articles on COVID-19 published in scholarly journals, 533 (25%) contained original data. The majority was published by authors from China (75%) and funded by Chinese sponsors (75%); a quarter was published in the Chinese language. Among 312 articles that self-reported study design, the most frequent were retrospective studies (N = 88; 28%) and case reports (N = 86; 28%), analyzing patients' characteristics (38%). Median Journal Impact Factor of journals where articles were published was 5.099. Among 1088 analyzed preprint articles, the majority came from authors affiliated in China (51%) and were funded by sources in China (46%). Less than half reported study design; the majority were modeling studies (62%), and analyzed transmission/risk/prevalence (43%). Of the 927 analyzed registered trials, the majority were interventional (58%). Half were already recruiting participants. The location for the conduct of the trial in the majority was China (N = 522; 63%). The median number of planned participants was 140 (range: 1 to 15,000,000). Registered intervention trials used highly heterogeneous primary outcomes and tested highly heterogeneous interventions; the most frequently studied interventions were hydroxychloroquine (N = 39; 7.2%) and chloroquine (N = 16; 3%). CONCLUSIONS: Early articles on COVID-19 were predominantly retrospective case reports and modeling studies. The diversity of outcomes used in intervention trial protocols indicates the urgent need for defining a core outcome set for COVID-19 research. Chinese scholars had a head start in reporting about the new disease, but publishing articles in Chinese may limit their global reach. Mapping publications with original data can help finding gaps that will help us respond better to the new public health emergency.