scholarly journals Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study

2017 ◽  
Vol 13 (1) ◽  
Author(s):  
K. J. Wareham ◽  
R. M. Hyde ◽  
D. Grindlay ◽  
M. L. Brennan ◽  
R. S. Dean
BMJ ◽  
2009 ◽  
Vol 339 (oct19 1) ◽  
pp. b4012-b4012 ◽  
Author(s):  
L. Hartling ◽  
M. Ospina ◽  
Y. Liang ◽  
D. M Dryden ◽  
N. Hooton ◽  
...  

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022233 ◽  
Author(s):  
Amanda Jane Blatch-Jones ◽  
Wei Pek ◽  
Emma Kirkpatrick ◽  
Martin Ashton-Key

ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034635
Author(s):  
Junsheng Chen ◽  
Yubin Cao ◽  
Meijie Wang ◽  
Xueqi Gan ◽  
Chunjie Li ◽  
...  

ObjectivesTo analyse the relationship between demographic characteristics, reporting quality and final publication rate of conference abstracts of prosthodontic randomised-controlled trials (RCTs) presented at International Association for Dental Research (IADR) general sessions (2002–2015).DesignA cross-sectional study on conference abstracts.MethodsConference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015) were obtained. Literature search was performed in multiple databases to confirm the final publication status of conference abstracts. Two investigators independently extracted the data including conference date, origin, presentation type, exact p value, number of centres, institution type, overall conclusion, subspecialty, publication time and journal. The reporting quality of abstracts was assessed by two investigators according to the Consolidated Standards of Reporting Trials statement. The relationship between demographic characteristics, reporting quality and final publication was analysed by χ2test.Setting, participants and interventionsNot applicable.Primary and secondary outcome measuresFinal publication rate, demographic characteristics and reporting quality of conference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015).ResultsOf the 340 prosthodontic RCT abstracts, 43.24% were published. The mean time to final publication was 22.86 months. Europe contributed the most number of abstracts but Asia and Australia had the highest publication rate. Oral presentation, multicentre trial and complete denture and overdenture subspecialty were associated with a higher publication rate. Reporting quality of eligibility criteria of participants, random assignment and primary outcome results for each group correlated with a higher final publication rate.ConclusionsOver half of conference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015) were unpublished. Oral presentation and multiple centres were associated with higher publication rates. Abstracts’ reporting quality addressing participant recruitment, assignment and primary results correlated with trials’ validity and applicability. Conference attendees may refer to this research to identify valid and applicable prosthodontic trials but should treat and apply results cautiously.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017462 ◽  
Author(s):  
Anthony Chauvin ◽  
David Moher ◽  
Doug Altman ◽  
David L Schriger ◽  
Sabina Alam ◽  
...  

IntroductionSystematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports.Methods and analysisThis is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals,BMJ,BMJ OpenandAnnals of Emergency Medicineand indexed with the publication type ‘Randomised Controlled Trial’. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers.Ethics and disseminationThe research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent.Trial registration numberNCT03119376.


2016 ◽  
Vol 4 (1) ◽  
pp. 19
Author(s):  
Tanzeela Imran ◽  
Naseer Ahmed ◽  
Bushra Nazeer

The purpose of this study was to determine the patterns of occlusal contacts and location in intercuspal position of natural teeth.A cross-sectional study was conducted with a sample size of around seventy patients within a span of seven months, complete mouth impressions were made of each patient with hydrocolloid material and the impressions were poured in dental stone. The contact areas of the teeth in the maximum intercuspation position were determined by wax. Three distinct types of indentations were noted on the wax interocclusal record. Then similarly the centric occlusion contacts of the teeth on the cast were determined by interposing a new piece of wax, approximating the casts in the maximum intercuspation position by hand, and applying pressure. The oral and cast wax recordings were then compared. The occlusal relation for each individual tooth was then classified and recorded in a Performa.Following wax interocclusal record of natural teeth in intercuspation an ideal occlusion was absent, a difference in morphology of anterior and posterior teeth was also evident that inevitably affects the nature of occlusal contacts.The ideal occlusion was not found in any of the patient’s investigation.


2013 ◽  
Vol 202 (2) ◽  
pp. 100-107 ◽  
Author(s):  
Rebecca E. S. Anglin ◽  
Zainab Samaan ◽  
Stephen D. Walter ◽  
Sarah D. McDonald

BackgroundThere is conflicting evidence about the relationship between vitamin D deficiency and depression, and a systematic assessment of the literature has not been available.AimsTo determine the relationship, if any, between vitamin D deficiency and depression.MethodA systematic review and meta-analysis of observational studies and randomised controlled trials was conducted.ResultsOne case-control study, ten cross-sectional studies and three cohort studies with a total of 31 424 participants were analysed. Lower vitamin D levels were found in people with depression compared with controls (SMD = 0.60,95% Cl 0.23–0.97) and there was an increased odds ratio of depression for the lowest v. highest vitamin D categories in the cross-sectional studies (OR = 1.31, 95% CI 1.0–1.71). The cohort studies showed a significantly increased hazard ratio of depression for the lowest v. highest vitamin D categories (HR=2.21, 95% CI 1.40–3.49).ConclusionsOur analyses are consistent with the hypothesis that low vitamin D concentration is associated with depression, and highlight the need for randomised controlled trials of vitamin D for the prevention and treatment of depression to determine whether this association is causal.


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