A review of clinical trial registry use in dermatology systematic reviews

2018 ◽  
Vol 178 (5) ◽  
pp. 1218-1219
Author(s):  
T. Combs ◽  
P. Atakpo ◽  
M. Vassar
Keyword(s):  
Clinical Trial ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Clinical Trial Registry

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reporting bias (i.e. selective reporting and publication bias), and determine the nature and number of ongoing or unpublished studies for planning review updates.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

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.

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.

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.

Clinical Trial Registry Use in Orthopaedic Surgery Systematic Reviews

2021 ◽  
Vol 103 (10) ◽  
pp. e41
Author(s):  
Arjun K. Reddy ◽  
J. Michael Anderson ◽  
Harrison M. Gray ◽  
Keith Fishbeck ◽  
Matt Vassar
Keyword(s):  
Clinical Trial ◽  
Systematic Reviews ◽  
Orthopaedic Surgery ◽  
Trial Registry ◽  
Clinical Trial Registry

scholarly journals Primary success of electrical cardioversion for new-onset atrial fibrillation and its association with clinical course in non-cardiac critically ill patients: sub-analysis of a multicenter observational study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Nozomu Shima ◽  
Kyohei Miyamoto ◽  
Seiya Kato ◽  
Takuo Yoshida ◽  
Shigehiko Uchino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Sinus Rhythm ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Icu Discharge ◽  
Primary Success ◽  
Success Group ◽  
Onset Atrial Fibrillation ◽  
New Onset

Abstract Background Electrical cardioversion (ECV) is widely used to restore sinus rhythm in critically ill adult patients with atrial fibrillation, although its prognostic value is uncertain. This study aims to elucidate the clinical meaning of successful ECV. Methods This is a sub-analysis of the AFTER-ICU study, a multicenter prospective study with a cohort of 423 adult non-cardiac patients with new-onset atrial fibrillation (AF). Patients that underwent ECV within 7 days after initial onset of AF were included in the sub-analysis. We compared intensive care unit (ICU) and overall hospital mortality, survival time within 30 days, cardiac rhythm at ICU discharge, and the length of ICU and overall hospital stay between patients whose sinus rhythm was restored immediately after the first ECV session (primary success group) and those in whom it was not restored (unsuccessful group). To find the factors related to the primary success of ECV, we also compared patient characteristics, the delivered energy, and pretreatment. Results Sixty-five patients received ECV and were included in this study. Although 35 patients (54%) had primary success, recurrence of AF occurred in 24 of these patients (69%). At ICU discharge, three patients still had AF in the unsuccessful group, but no patients in the primary success group still had AF. ICU mortality was 34% in the primary success group and 17% in the unsuccessful group (P = 0.10). Survival time within 30 days did not differ between the groups. Delivered energy and pretreatment were not associated with primary success of ECV. Conclusions The primary success rate of ECV for new-onset AF in adult non-cardiac ICU population was low, and even if it succeeded, the subsequent recurrence rate was high. Primary success of ECV did not affect the rate of mortality. Pretreatment and delivered energy were not associated with the primary success of ECV. Trial registration UMIN clinical trial registry, the Japanese clinical trial registry (registration number: UMIN000026401, March 31, 2017).

scholarly journals Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study

2021 ◽  
Author(s):  
Mayte Buchbender ◽  
Jakob Fehlhofer ◽  
Peter Proff ◽  
Tobias Möst ◽  
Jutta Ries ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Oral Cavity ◽  
Bowel Disease ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Expression Levels ◽  
Inflammatory Bowel ◽  
Group 2

Abstract Objectives Inflammatory bowel disease (IBD) has multiple impacts on soft and hard tissues in the oral cavity. The aim of this study was to analyze the expression of cytokines in biofilm samples from patients suffering from IBD and compare them to healthy patients. It was hypothesized that different cytokine expression levels and clinical associations might be drawn. Material and methods A total of 56 biofilm samples from three different patient cohorts (group 0 = healthy, HC n = 30; group 1 = Crohn’s disease, CD, n = 19; group 2 = ulcerative colitis, UC, n = 7) were examined for the expression levels of the cytokine interleukins IL-2, -6, and -10; matrix metalloproteinases 7 and 9; and surface antigens CD90/CD11a by quantitative real-time PCR and according to clinical parameters (plaque index, BOP, PD, DMFT, CAL). Relative gene expression was determined using the ∆∆CT method. Results The mean BOP values (p = 0.001) and PD (p = 0.000) were significantly higher in the CD group compared to controls. Expression of IL-10 was significantly higher in the CD (p = 0.004) and UC groups (p = 0.022). Expression of MMP-7 was significantly higher in the CD group (p = 0.032). IBD patients treated with TNF inhibitors (p = 0.007) or other immunosuppressants (p = 0.014) showed significant overexpression of IL-10 compared to controls. Conclusion Different expression levels of IL-10 and MMP-7 were detected in plaque samples from IBD patients. As only BOP was significantly increased, we conclude that no clinical impairment of periodontal tissue occurred in IBD patients. Clinical relevance With the worldwide increasing incidence of IBD, it is important to obtain insights into the effects of the disease on the oral cavity. The study was registered (01.09.2020) at the German clinical trial registry (DRKS00022956). Clinical trial registration The study is registered at the German clinical trial registry (DRKS00022956).

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