scholarly journals Publish or perish: reporting characteristics of peer-reviewed publications, pre-prints and registered studies on the COVID-19 pandemic

2020 ◽  
Author(s):  
S Gianola ◽  
TS Jesus ◽  
S Bargeri ◽  
G Castellini
Keyword(s):  
Clinical Trial ◽  
Systematic Reviews ◽  
Case Reports ◽  
Time Frame ◽  
Trial Registry ◽  
Medical Subject Headings ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Publish Or Perish ◽  
Print Publications

AbstractBackgroundThe COVID-19 pandemic has resulted in a mass of academic papers being published in a very brief span of time. Our aim was to compare the amount and reporting characteristics of COVID-19 related peer-reviewed and pre-prints publications. We also investigated the amount of ongoing trials and systematic reviews.Methods and findingsA cross-sectional study of publications covering the COVID-19 pandemic time frame, up to May 20, 2020 was conducted. PubMed with appropriate combinations of Medical Subject Headings and COVID-19 section of MedRxiv and BioRxiv archives were searched. We examined Clinicaltrial.gov, Chinese Clinical Trial Registry, EU Register and 15 other trial registers as well as the international prospective register of systematic reviews (PROSPERO). Characteristics of each publication source were extracted. Regression analyses and Z tests were used to analyze publication trends over the weeks and compare their relative proportions.We found 3635 peer-reviewed publications and 3805 pre-prints, of which 8.6% (n=329) were published in indexed journals. Peer-reviewed and pre-print publications amount both increased significantly over time (p<0.001). Case reports (peer-reviewed: 6% vs pre-prints: 0.9%, p<0.001) and letters (17.4% vs 0.5%, p<0.001) accounted for a greater share of the peer-reviewed compared to pre-print publications. In turn, randomized controlled trials (0.22% vs 0.63% p<0.001) and systematic reviews (0.08% vs 5%) accounted for a significantly greater share of the pre-print publications. Clinicaltrials.gov, Chinese Clinical Trial Registry and EU register included 57.9%, 49.5 % and 98.9% trials mostly still “recruiting”. PROSPERO amounted to 962 systematic review protocols.ConclusionPre-prints were slightly more prevalent than peer-reviewed publications, yet both are growing. To fill the void given by the absence of published primary studies, immediate opinions (i.e., letters) has virulently been published in PubMed. However, preprints has been promoted as rapid responses to give direct and promptly access at scientific findings in this pandemic.

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

Guidance for reporting clinical trial registry records and published protocols use in systematic reviews of interventions

2019 ◽  
Author(s):  
Julia Bidonde ◽  
Jose Francisco Meneses-Echavez ◽  
Angela Jean Busch ◽  
Catherine Boden
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Systematic Reviews ◽  
Cochrane Collaboration ◽  
Subject Area ◽  
Selective Reporting ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Reporting Practices ◽  
Starting Point

Abstract Background: Transparency is a tenet of systematic reviews. Searching for clinical trial registry records and published protocols has become a mandatory standard when conducting a systematic review of interventions. However, there is no comprehensive guidance for review authors on how to report the use of registry records and published protocols in their systematic review. The objective of this study was to generate initial guidance to assist authors of systematic reviews of interventions in the reporting of registry records and published protocols in systematic reviews of interventions. Methods: We used a compilation of the procedures recommended by expert organizations (e.g., Cochrane Collaboration) related to the reporting of use of registry records and published protocols in the conduct of systematic reviews. The compilation was developed by one of the authors in this study and served as a starting point in developing the algorithm. We extracted current practice data related to registry records and published protocols from a stratified random sample of Cochrane systematic reviews of interventions published between 2015 and 2016 (n=169). We identified examples that adhered to or extended the current guidance. Based on the on the elements above, we created the algorithm to bridge gaps and improve current reporting practices. Results: Trial protocols should be used to account for all evidence in a subject area, evaluate reporting bias (i.e. selective reporting and publication bias), and determine the nature and number of ongoing or unpublished studies for planning review updates. Review authors’ terminology (e.g., ongoing, terminated) and consequent reporting in the review should reflect the phase of the trial found. Protocols should be clearly and consistently reported throughout the review (e.g. abstract, methods, results) as is done with published articles. Conclusions: Our study expands on available guidance to describe in greater detail the reporting of registry records and published protocols for review authors. We believe this is a timely investigation that will increase transparency in the reporting of trial records in systematic reviews of interventions and bring clarification to current fuzziness in terminology. We invite researchers to provide feedback on our work for its improvement and dissemination. Trial Registration: not applicable

Clinical trial registry use in anaesthesiology systematic reviews

2017 ◽  
Vol 34 (12) ◽  
pp. 797-807 ◽  
Author(s):  
Blake A. Umberham ◽  
Byron N. Detweiler ◽  
Matthew T. Sims ◽  
Matt Vassar
Keyword(s):  
Clinical Trial ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Clinical Trial Registry

Clinical trial registry use in minimally invasive surgical oncology systematic reviews and meta-analyses

2019 ◽  
Vol 25 (2) ◽  
pp. 1.1-2
Author(s):  
Kaleb Fuller ◽  
Aaron Bowers ◽  
Matt Vassar
Keyword(s):  
Clinical Trial ◽  
Minimally Invasive ◽  
Publication Bias ◽  
Systematic Reviews ◽  
Clinical Decision Making ◽  
Surgical Oncology ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Minimally Invasive Surgical ◽  
Meta Analyses

Publication bias can arise in systematic reviews when unpublished data are omitted and lead to inaccurate clinical decision making and adverse clinical outcomes. By conducting searches of clinical trial registries (CTRs), researchers can create more accurate systematic reviews and mitigate the risk of publication bias. The aims of this study are: to evaluate CTR use in systematic reviews and meta-analyses within the minimally invasive surgical oncology (MISO) literature; to conduct a search of ClinicalTrials.gov for a subset of reviews to determine if eligible trials exist that could have been used. This is a cross-sectional study of 197 systematic reviews and meta-analyses retrieved from PubMed. Of 137 included studies, 18 (13.1%) reported searching a CTR. Our ClinicalTrials.gov search revealed that of the 25 randomly selected systematic reviews that failed to conduct a trial registry search, 16 (64.0%) would have identified additional data sources. MISO systematic reviews and meta-analyses do not regularly use CTRs in their data collection, despite eligible trials being freely available.

Evaluation of Fontan failure by classifying the severity of Fontan-associated liver disease: a single-centre cross-sectional study

2020 ◽  
Author(s):  
Anastasia Schleiger ◽  
Peter Kramer ◽  
Madeleine Salzmann ◽  
Friederike Danne ◽  
Stephan Schubert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Liver Disease ◽  
Transient Elastography ◽  
Venous Pressure ◽  
Cardiopulmonary Exercise Testing ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Fontan Failure

Abstract OBJECTIVES Fontan-associated liver disease (FALD) is a hallmark of the failing Fontan circulation, but no general classification of FALD severity exists. In this study, we propose a scoring system to grade the severity of FALD and analyse its applicability for evaluation of Fontan failure. METHODS From 2017 to 2019, a total of 129 successive Fontan patients received a comprehensive hepatic assessment. The FALD score was based on results from laboratory testing, hepatic ultrasound and transient elastography by assigning scoring points for each abnormality detected. FALD severity was graded mild, moderate and severe. Haemodynamic assessment was performed using echocardiography, cardiopulmonary exercise testing and catheterization. RESULTS FALD was graded absent/ mild, moderate and severe in 53, 26 and 50 patients, respectively. Cardiopulmonary capacity was significantly impaired in patients with severe FALD compared to patients with absent/mild FALD (P = 0.001). The FALD score significantly correlated with pulmonary artery pressure (P = 0.001), end-diastolic ventricular pressure (P &lt; 0.001), hepatic venous pressure (P = 0.004) and wedged hepatic venous pressure (P = 0.009). Fontan failure was present in 21 patients. FALD was graded moderate in 2 and severe in 19 of these patients. The FALD score accurately discriminated patients with and without Fontan failure (sensitivity 90.5%, specificity 71.3%). CONCLUSIONS The FALD score significantly correlates with impaired Fontan haemodynamics. A cut-off value ≥6.0 has a high diagnostic accuracy in detecting Fontan failure. Clinical trial registry DRKS (GCTR, German clinical trial registry) Clinical trial registration number DRKS00015039

scholarly journals Characteristics of COVID-19 Clinical Trials in India Based on the Registration Data on CTRI (Clinical Trials Registry- India): a cross-sectional analysis

2020 ◽  
Author(s):  
P Sathiyarajeswaran ◽  
MS Shree Devi ◽  
K Kanakavalli ◽  
NP Vinod
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Multiple Drug ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Registration Data ◽  
Post Marketing Surveillance ◽  
Sectional Analysis

AbstractObjectivesThe 2019 pandemic of coronavirus disease (COVID-19) has prompted several efforts to find safe and effective drugs, but little is understood as to where early efforts were centered. Several clinical trials, both Allopathy and AYUSH medicines have been registered in the Clinical Trial Registry of India (CTRI). We aimed to characterize and extract relevant data registered under CTRI for COVID-19.Materials and MethodsA cross-sectional analysis was performed of clinical trials for the treatment of COVID-19 that were registered in the Clinical Trial Registry of India (CTRI) from 1st March 2020 to 22nd June 2020. Relevant trial records were downloaded, deduplicated, and independently analyzed by three reviewers.Main outcomesTrial intervention, design, sponsorship, phase of the trial, and indicated outcomes.Results233 COVID-19 clinical trials, was registered from India in CTRI. Out of these, 146 were Interventional trials, 84 Observational trials, and three Post-marketing surveillance. Questionnaire and survey-based intervention occupy a significant portion. Randomized control trials are large in number 37.8% than non-randomized. 20% of the trials were recruiting patients, and the Research institution (34%) sponsored more than half of the trials. Global trials are minimal, occupying 3% of total trials and Indian trials were 97%. In most of the trials, the interventional agent is either multiple drug combinations or compound drug formulations compared to single drug administration. Among the trials, 46 Allopathic interventions, 41 Ayurveda interventions, 14 Homeopathy interventions, one in Unani, and 2 in yoga and Naturopathy.ConclusionThis study will provide a background of COVID-19 clinical trials registered in CTRI and provide specific issues observed related to clinical trial designs, which offer information to perform clinical trials on COVID-19

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