scholarly journals Methodological Rigor in COVID-19 Clinical Research: A Systematic Review and Case-Control Analysis

Author(s):  
Richard G Jung ◽  
Pietro Di Santo ◽  
Cole Clifford ◽  
Graeme Prosperi-Porta ◽  
Stephanie Skanes ◽  
...  

Objective: To systematically evaluate the quality of reporting of currently available COVID-19 studies compared to historical controls. Design: A systematic review and case-control analysis Data sources: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials until May 14, 2020 Study selection: All original clinical literature evaluating COVID-19 or SARS-CoV2 were identified and 1:1 historical control of the same study type in the same published journal was matched from the previous year Data extraction: Two independent reviewers screened titles, abstracts, and full-texts and independently assessed methodological quality using Cochrane Risk of Bias Tool, Newcastle-Ottawa Scale, QUADAS-2 Score, or case series checklist. Results: 9895 titles and abstracts were screened and 686 COVID-19 articles were included in the final analysis in which 380 (55.4%) were case series, 199 (29.0%) were cohort, 63 (9.2%) were diagnostic, 38 (5.5%) were case-control, and 6 (0.9%) were randomized controlled trials. Overall, high quality/low-bias studies represented less than half of COVID-19 articles - 49.0% of case series, 43.9% of cohort, 31.6% of case-control, and 6.4% of diagnostic studies. We matched 539 control articles to COVID-19 articles from the same journal in the previous year for a final analysis of 1078 articles. The median time to acceptance was 13.0 (IQR, 5.0-25.0) days in COVID-19 articles vs. 110.0 (IQR, 71.0-156.0) days in control articles (p<0.0001). Overall, methodological quality was lower in COVID-19 articles with 220 COVID-19 articles of high quality (41.0%) vs. 392 control articles (73.3%, p<0.0001) with similar results when stratified by study design. In both unadjusted and adjusted logistic regression, COVID-19 articles were associated with lower methodological quality (odds ratio, 0.25; 95% CI, 0.20 to 0.33, p<0.0001). Conclusion: Currently published COVID-19 studies were accepted more quickly and were found to be of lower methodological quality than comparative studies published in the same journal. Given the implications of these studies to medical decision making and government policy, greater effort to appropriately weigh the existing evidence in the context of emerging high-quality research is needed. Study registration: PROSPERO: CRD42020187318

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
M Wong ◽  
M Ghobrial ◽  
W M Han ◽  
J Alsousou ◽  
D Chou ◽  
...  

Abstract Aim A “Floating Hip” injury describes a simultaneous ipsilateral fracture of the femur and pelvis. We performed a descriptive study of the injury patterns, management, and outcomes of floating hip patients, and compared these patients to those with similar pelvic fractures without femoral involvement. Method This was a retrospective case-series review with secondary case-control analysis. Medical records of patients presenting with a floating hip injury to our tertiary orthopaedics department between 2015 and 2020 were reviewed. The control group comprised of patients with pelvic fractures but without associated femoral fractures, matched by age, sex, pelvic fracture classification, and mechanism of injury. Results 46 Floating Hip cases were identified (34 males), of average age 39 (15-86) years. 20 had acetabular fractures, 21 had pelvic ring fractures and 5 had both fractures, concomitant with ipsilateral femoral fractures. The most common site of femoral fracture was mid-shaft (21.7%), followed by distal (19.6%). 69.6% of P/A fractures were managed surgically, with ORIF (43%) the most common option. 4 (12.50%) patients suffered complications, including 2 infections and 1 DVT. Compared to controls, Floating Hip patients were more likely to require surgical management (67.6% vs 47.8%, p = 0.03), and had higher rates of surgical complications (12.5% vs 4.6%), though not statistically significant (p = 0.3). Conclusions Our study describes the patterns, management, and outcomes of Floating Hip injuries, and observes differences in the management and complications compared to similar pelvic fractures without femoral involvement. These findings suggest Floating Hip cases may warrant consideration as a distinct injury pattern.


2006 ◽  
Vol 22 (4) ◽  
pp. 408-418 ◽  
Author(s):  
Catriona M. Mc Daid ◽  
Suzanne Hartley ◽  
Anne-Marie Bagnall ◽  
Gill Ritchie ◽  
Kate Light ◽  
...  

Objectives: The aim of this study was to conduct a systematic review of the evidence for treatments for retinoblastoma in children.Methods: Seventeen electronic databases were searched. Two reviewers independently selected studies. Studies of participants diagnosed with childhood retinoblastoma, any interventions, and all clinical outcomes were eligible. Randomized and nonrandomized controlled trials and cohort studies with clear comparisons between treatment groups were included. Methodological quality was assessed.Results: Thirty-one observational comparative studies were included, of which twenty-seven were retrospective. The methodological quality was generally poor, with a high risk of selection bias in all studies. Although there were high levels of treatment success in many of the studies, due to the limitations of the evidence identified, it was not possible to make meaningful and robust conclusions about the relative effectiveness of different treatment approaches for retinoblastoma in children.Conclusions: Good quality randomized controlled trials are required. Where controlled trials are not feasible, only high quality prospective, nonrandomized studies should be given consideration, due to the generally higher risk of bias in retrospective studies.


2016 ◽  
Vol 25 (11) ◽  
pp. 1313-1319 ◽  
Author(s):  
Annemie Stewart ◽  
Rannakoe Lehloenya ◽  
Andrew Boulle ◽  
Renee de Waal ◽  
Gary Maartens ◽  
...  

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Chao-qin Gou ◽  
Jing Gao ◽  
Chen-xi Wu ◽  
Ding-xi Bai ◽  
Hong-yuan Mou ◽  
...  

Primary dysmenorrhea (PD) is one of the most common diseases in gynecology at present. Some clinical trials have reported the effects of moxibustion and confirmed temporal factors are the important elements influencing the efficacy of moxibustion. However, no systematic review has yet been conducted. In this study, we assessed the effects of moxibustion in patients with PD enrolled in randomized controlled trials (RCTs) and the difference among different intervention times to start moxibustion. We extracted data for studies searched from 10 electronic databases and evaluated the methodological quality of the included studies. We discussed three outcomes: effective rate, pain remission, and the level of PGF2αin serum. Current clinical researches showed that, compared with nonmoxibustion treatments for PD, moxibustion leads to higher effective rate and lower level of PGF2αin serum. However, there was no difference in using moxibustion to treat PD at different intervention times. Based on the theory of Chinese medicine and the results of this study, choosing 5 ± 2 days before menstruation to start moxibustion can achieve good efficacy for PD patients. However, more high-quality RCTs are needed to confirm the conclusions.


Author(s):  
Subhranil Saha ◽  
Malay Mundle ◽  
Shubhamoy Ghosh ◽  
Munmun Koley ◽  
Sk. Intaj Hossain

Background & Aim: Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine. The objective of this review is to test whether there is enough evidence of efficacy of homeopathy from conducted clinical trials in humans suffering from HIV/AIDS. Methods: The study design was criteria-based systematic review of cumulative research and assessment of the methodological quality of only 5 published clinical trials and one review article. Among the clinical outcome studies, 3 studies were of open-label, non-randomized, non-controlled format, 2 were randomized controlled trials and one was a set of replication study. The qualities of the trials were evaluated using a list of validated and pre-defined criteria of good methodology, and the outcomes of the trials were interpreted in relation to their quality. Main outcome measures were methodological qualities in terms of consideration of threats to external, internal, construct and statistical conclusion validity. Results: Trials were too few in number and were not of very high quality. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. The results of this review may be complicated by publication bias. Conclusions: At this moment, the evidences are not sufficient to draw definitive conclusions. So, further evaluation of homeopathy by well-performed controlled trials of high methodological quality is required.


2018 ◽  
Author(s):  
David R Vago ◽  
Resh Gupta ◽  
Sara Lazar

One potential pathway by which mindfulness-based meditation improves health outcomes is through changes in cognitive functioning. A systematic review of randomized controlled trials of mindfulness-based interventions (MBIs) was conducted with a focus on assessing the state of the evidence for effects on cognitive processes and associated assays. Here, we comment on confounding issues surrounding the reporting of these and related findings, including 1) criteria that appropriately define an MBI; 2) limitations of assays used to measure cognition; and 3) methodological quality of MBI trials and reporting of findings. Because these issues contribute to potentially distorted interpretations of existing data, we offer constructive means for interpretation and recommendations for moving the field of mindfulness research forward regarding the effects on cognition.


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