scholarly journals A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials

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.

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 ◽  
2009 ◽  
Vol 339 (oct19 1) ◽  
pp. b4012-b4012 ◽  
Author(s):  
L. Hartling ◽  
M. Ospina ◽  
Y. Liang ◽  
D. M Dryden ◽  
N. Hooton ◽  
...  

2020 ◽  
Vol 22 (3) ◽  
pp. 141-145
Author(s):  
Krishna Chandra Devkota ◽  
S Hamal ◽  
PP Panta

Pleural effusion is present when there is >15ml of fluid is accumulated in the pleural space. It can be divided into two types; exudative and transudative pleural effusion. Tuberculosis and parapneumonic effusion are the common cause of exudative pleural effusion whereas heart failure accounts for most of the cases of transudative pleural effusion. This study was a hospital based cross sectional study performed at Nepal Medical College during the period of January 2016-December 2016. A total of 50 patients who fulfilled the inclusion criteria were enrolled. Pleural effusion was confirmed by clinical examination and radiology. After confirmation of pleural effusion, pleural fluid was aspirated and was analysed for protein, LDH, cholesterol. The Heffner criteria was compared with Light criteria to classify exudative or transudative pleural effusion. Among 50 patients, 30 were male and 20 were female. The mean age of patient was 45.4±21.85 years. The sensitivity and specificity of using Light criteria to detect the two type of pleural effusion was 100% and 90.9%, whereas using Heffner criteria was 94.87%, 100% respectively(P<0.01). There are variety of causes for development of pleural effusion and no one criteria is definite to differentiate between exudative or transudative effusion. In this study Light criteria was more sensitive whereas Heffner criteria was more specific to classify exudative pleural effusion. Hence a combination of criteria might be useful in case where there is difficulty to identify the cause of pleural effusion.


2021 ◽  
pp. 036354652098781
Author(s):  
Mathias Paiva ◽  
Lars Blønd ◽  
Per Hölmich ◽  
Kristoffer Weisskirchner Barfod

Background: Tibial tubercle–trochlear groove (TT-TG) distance is often used as a measure of lateralization of the TT and is important for surgical planning. Purpose: To investigate if increased TT-TG distance measured on axial magnetic resonance images is due to lateralization of the TT or medialization of the TG. Study Design: Cross-sectional study; Level of evidence, 3. Methods: A total of 84 knees (28 normal [NK], 28 with trochlear dysplasia [TD], and 28 with patellar dislocation without TD [PD]) were examined. The medial border of the posterior cruciate ligament (PCL) was chosen as the central anatomic landmark. The distance from the TT to PCL (TT-PCL) was measured to examine the lateralization of the TT. The distance from the TG to the PCL (TG-PCL) was measured to examine the medialization of the TG. Between-group differences were investigated by use of 1-way analysis of variance. Results: The mean values for TT-TG distance were 8.7 ± 3.6 mm for NK, 12.1 ± 6.0 mm for PD, and 16.7 ± 4.3 mm in the TD group ( P < .01). The mean values for TT-PCL distance were 18.5 ± 3.6 mm for NK, 18.5 ± 4.5 mm for PD, and 21.2 ± 4.2 mm in the TD group ( P = .03). The mean values for TG-PCL distance were 9.6 ± 3.0 mm for NK, 7.1 ± 3.4 mm for PD, and 5.1 ± 3.3 mm in the dysplastic group ( P < .01). Conclusion: The present results indicate that increased TT-TG distance is due to medialization of the TG and not lateralization of the TT. Knees with TD had increased TT-TG distance compared with the knees of the control group and the knees with PD. The TT-PCL distance did not differ significantly between groups, whereas the TG-PCL distance declined with increased TT-TG.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Akhila Doddamani ◽  
A. B. Kirthinath Ballala ◽  
Sharath P. Madhyastha ◽  
Asha Kamath ◽  
Muralidhar M. Kulkarni

Abstract Background India is currently facing a rising epidemic of Non-Communicable Diseases (NCDs). Identification of modifiable risk factors is of paramount importance to curb this menace. Fishermen are one of the most vulnerable occupational groups with unique characteristics that make them prone to acquire NCDs, as a significant share of their life is spent at sea. Hence, this study was planned to ascertain the burden of NCDs, determine various risk factors of NCDs, and measure the association between risk factors and NCDs among fishermen of Coastal Karnataka in South India. Methods A cross-sectional study was conducted among 681 fishermen aged 18 years and above as per the semi-structured interview schedule for two years (2017–2019). A convenience sampling strategy was adopted. The data was entered and analyzed using SPSS v.15.0. The results were described in terms of proportions and their 95% confidence intervals. Continuous data were summarized using the mean and standard deviation or median and interquartile range depending on the skewness of data. Chi-square test was used to study the association between NCDs and modifiable risk factors. Multiple logistic regression was used to identify risk factors of NCDs. Results The mean (SD) age of the population was 42.5 (SD 12.5) years. The mean years involved in fishing was 19.8 years (SD 10.9). More than half (59.5%) of the study participants had severe stress and most (80.3%) were ever substance users. Advancing age, not being able to contact family while at sea, poor dietary practice, ever substance use, increasing waist circumference were significant correlates of NCDs. Conclusions The commonly prevalent risk factors of NCDs among fishermen included poor dietary practice, higher stress levels, substance use, increasing waist circumference, and inability to contact with family while at sea. Hypertension and Diabetes were the two common NCDs in the study population. There is a need for immediate attention in managing NCDs’ risk factors by promoting a healthy lifestyle by primary health care providers through a sustainable community awareness program targeting fishermen at a convenient time and location, either at the sea-port or meeting places. Harmful effects of substance use, healthy dietary practices, and the importance of physical activity outside their job need emphasis. In addition, screening programs should be organized with the help of boat owners and fishing associations at-least once a year to pick up NCDs at an early stage.


Author(s):  
AA Toubasi ◽  
BR Khraisat ◽  
RB AbuAnzeh ◽  
HM Kalbouneh

Objective Medicine is considered one if not the most stressful educational field. Thus, the aim of this study is to investigate the prevalence of stress and poor sleeping quality among medical students and the association between them. Method This cross-sectional study was conducted at the University of Jordan on second- and third-year medical students. The questionnaire consisted of: 1) Demographics; 2) The assessment tools which were Pittsburgh Quality of Sleep Index (PSQI) and Kessler Psychological Distress Status (K10). Binary logistic regression, chi-square and linear regression were used to investigate the association between PSQI, K10, and their determinants. Results The mean for PSQI score was 6.76 ± 3.32. PSQI scores interpretation revealed that 61.7% of the 282 participants of this study were poor sleepers. Logistic regression results showed that only the category of not napping at all from the napping hours variable was significantly associated with sleeping quality. Furthermore, the mean of K10 scores was 24.5 ± 8.5. K10 scores revealed that 66.3% of the participants were stressed. Logistic regression results showed that gender and regular exercise were significantly associated with psychological distress. Additionally, chi-square test, logistic regression and linear regression showed that PSQI was significantly associated with K10 (P <0.01). Conclusions Stress and poor sleeping quality in medical students at the University of Jordan were highly prevalent and strongly associated. What determined PSQI was daytime napping, and for K10 were regular exercise and gender. Further investigations into stress and sleep quality in the Arabian region are needed.


2021 ◽  
Vol 10 ◽  
Author(s):  
Rachel M. Harris ◽  
Angela M. C. Rose ◽  
Suzanne Soares-Wynter ◽  
Nigel Unwin

Abstract Our objective was to describe, for the first time in an English-speaking Caribbean country, the contribution of ultra-processed foods (UPFs) to nutrients linked to non-communicable disease. Using a cross-sectional study design, dietary data were collected from two non-consecutive 24-h dietary recalls. Recorded food items were then classified according to their degree of processing by the NOVA system. The present study took place in Barbados (2012–13). A representative population-based sample of 364 adult Barbadians (161 males and 203 females) aged 25–64 years participated in the study. UPFs represented 40⋅5 % (838 kcal/d; 95 % CI 791, 885) of mean energy intake. Sugar-sweetened beverages made the largest contribution to energy within the UPF category. Younger persons (25–44 years) consumed a significantly higher proportion of calories from UPF (NOVA group 4) compared with older persons (45–64 years). The mean energy shares of UPF ranged from 22⋅0 to 58⋅9 % for those in the lowest tertile to highest tertile. Within each tertile, the energy contribution was significantly higher in the younger age group (25–44 years) compared with the older (45–64 years). One-quarter of persons consume ≥50 % of their daily calories from UPF, this being significantly higher in younger persons. The ultra-processed diet fraction contained about six times the mean of free sugars and about 0⋅8 times the dietary fibre of the non-ultra-processed fraction (NOVA groups 1–3). Targeted interventions to decrease the consumption of UPF especially in younger persons is thus of high priority to improve the diet quality of Barbadians.


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