Reporting of Randomized Controlled Trials in Cleft Lip and Palate: A 10-Year Review

2017 ◽  
Vol 54 (2) ◽  
pp. 142-152 ◽  
Author(s):  
Joseph Hardwicke ◽  
Mohammad Nassimizadeh ◽  
Bruce Richard
Keyword(s):  
Randomized Controlled Trials ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Journal Article ◽  
Controlled Trials ◽  
Jadad Score ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
The Mean

Objectives Reviews of the quality of reporting of randomized controlled trials (RCTs) have recently been conducted in different surgical specialties. In this review of RCTs relating to cleft lip, cleft palate, and cleft lip and palate (CL/P), we investigate the quality of reporting against the Consolidated Standards of Reporting Trials (CONSORT) checklist. Design A systematic review of CL/P RCTs published from 2004 to 2013, with the included articles scored against the CONSORT checklist. Patients, Participants The literature search identified 174 articles. Studies were selected for participants with CL/P who were involved in an RCT with prospective data collection and reported in a full journal article. A total of 6352 participants were included from 65 CUP RCTs during the study period. Main Outcome Measures The methodological quality of RCTs was assessed using the CONSORT checklist and Jadad scale. Results The mean CONSORT score was 15.8, and the mean Jadad score was 3.3. There was a significant positive correlation between the CONSORT and Jadad score ( P < .0001, ρ = .47). The only significant correlation showed that with an increasing number of authors, both the CONSORT and the Jadad score increased. Conclusion This analysis has shown that that there are deficiencies in the transparent reporting of factors such as randomization implementation, blinding, and participant flow. Interventions, outcomes, and the interpretation of results are well presented. We would recommend that RCTs are conceived and undertaken using the CONSORT checklist and reported in a clear and reproducible manner.

Standards for reporting randomized controlled trials in neurosurgery

2011 ◽  
Vol 114 (2) ◽  
pp. 280-285 ◽  
Author(s):  
Erin N. Kiehna ◽  
Robert M. Starke ◽  
Nader Pouratian ◽  
Aaron S. Dumont
Keyword(s):  
New England ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Jadad Score ◽  
Quality Of Reporting ◽  
Medical Journals ◽  
Journal Editors ◽  
Randomized Controlled ◽  
Neurosurgical Patients

Object The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. Methods The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. Results In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39–44) compared with those published in neurosurgical journals (mean 26.4, range 17–38; p < 0.0001). Jadad scores were also significantly higher for the major medical journals (mean 3.42, range 2–5) than neurosurgical journals (mean 2.45, range 1–5; p = 0.05). Conclusions Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could improve the methodology and reporting of RCTs in neurosurgery.

scholarly journals EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Randomized Controlled Trials ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices

Surgery ◽  
2019 ◽  
Vol 165 (5) ◽  
pp. 965-969 ◽  
Author(s):  
Wenwen Chen ◽  
Jiajie Yu ◽  
Longhao Zhang ◽  
Guanyue Su ◽  
Wen Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Devices ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled

Quality of reporting of randomized controlled trials published in Intensive Care Medicine from 2001 to 2010

2013 ◽  
Vol 39 (8) ◽  
pp. 1386-1395 ◽  
Author(s):  
Nicola Latronico ◽  
Marta Metelli ◽  
Maddalena Turin ◽  
Simone Piva ◽  
Frank A. Rasulo ◽  
...  
Keyword(s):  
Intensive Care ◽  
Randomized Controlled Trials ◽  
Intensive Care Medicine ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled

Quality of surgical randomized controlled trials in hand surgery: a systematic review

2018 ◽  
Vol 43 (8) ◽  
pp. 801-807 ◽  
Author(s):  
Chao Long ◽  
Heather E. desJardins-Park ◽  
Rita Popat ◽  
Paige M. Fox
Keyword(s):  
Randomized Controlled Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Jadad Score ◽  
Surgical Interventions ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Treat Analysis ◽  
Over Time

We assessed the quantity, quality and trends of randomized controlled trials comparing hand surgical interventions. Study characteristics were collected for 125 randomized controlled trials comparing hand surgical interventions. The Jadad scale (0–5), which assesses methodological quality of trials, was calculated. Logistic regressions were conducted to determine associations with the Jadad score. The studies were published between 1981 and 2015, with an increase over time, most often in Journal of Hand Surgery (European). Mean study size was 68 patients. Mean Jadad score was 2.1, without improvement over time. Thirty percent conducted a power analysis and 8% an intention-to-treat analysis. Studies conducted in the United Kingdom and with smaller sample sizes, power analysis and intention-to-treat analysis were associated with a higher Jadad score. The quantity of trials has increased over time while methodological quality has remained low, indicating a need to improve quality of trials in hand surgery literature.

scholarly journals Assessing the quality of reporting of harms in randomized controlled trials published in high impact cardiovascular journals

2019 ◽  
Vol 6 (2) ◽  
pp. 177-179
Author(s):  
Muhammad Shahzeb Khan ◽  
Rohan Kumar Ochani ◽  
Asim Shaikh ◽  
Muthiah Vaduganathan ◽  
Safi U Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
High Impact ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled

A qualitative assessment of randomized controlled trials in otolaryngology

1998 ◽  
Vol 112 (5) ◽  
pp. 460-463 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony
Keyword(s):  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Qualitative Assessment ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Future Assessment ◽  
The Consort Statement ◽  
The Mean ◽  
Better Than

AbstractIn 1996 the CONSORT statement made recommendations on the strict reporting of randomized controlled trials (RCT). This will facilitate the future assessment of such trials and will highlight those trials that have been performed suboptimally and whose results may be biased.We have devised a scoring system, based on CONSORT, to assess RCT quality and by reading each original paper in full we have now assessed the quality of trials published from 1966 to 1995.The mean score for trials identified was 7.3 out of a maximum 12 points. No one journal was significantly better than the others. Trials in rhinology are reported better than head and neck oncology trials (mean scores 7.6 and 6.5 respectively). The past 30 years has not seen an improvement in the quality of the trials.The reporting of RCTs in the ENT literature is poor. CONSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.

scholarly journals Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review

2015 ◽  
Vol 15 (1) ◽  
Author(s):  
Faeze Gohari ◽  
Hamid Reza Baradaran ◽  
Morteza Tabatabaee ◽  
Shabnam Anijidani ◽  
Fatemeh Mohammadpour Touserkani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled

scholarly journals Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

2016 ◽  
Vol 124 (2) ◽  
pp. 558-568 ◽  
Author(s):  
Alireza Mansouri ◽  
Benjamin Cooper ◽  
Samuel M. Shin ◽  
Douglas Kondziolka
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
English Language ◽  
Sample Size Calculation ◽  
Median Number ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Mesh Terms

OBJECT Randomized-controlled trials (RCTs) are advocated to provide high-level medical evidence. However, in neurosurgery, there are barriers to conducting RCTs. The authors of this study sought to analyze the quality of neurosurgical RCTs since 2000 to determine the adequacy of their design and reporting. METHODS A search of the MEDLINE and EMBASE databases (2000–2014) was conducted. The medical subject heading (MeSH) terms used in the search included: “neurosurgery” OR “neurosurgical procedure,” “brain neoplasms,” “infarction” and “decompression,” “carotid stenosis,” “cerebral hemorrhage,” and “spinal fusion.” These studies were limited to RCTs, in humans, and in the English language. The Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scales were used to assess the quality of RCT design and reporting. The standardized median times cited (median citations divided by years since publication) were used to assess impact. A pragmatic-explanatory continuum indicator summary-based scale was used to assess the design of the studies as primarily pragmatic or explanatory. RESULTS Sixty-one articles were identified, and the following subspecialties were the most common: vascular (23, 37%), followed by functional neurosurgery and neurooncology (both 13, 21%). The following nations were the primary leaders in RCTs: US (25 studies, 41%), Germany (8 studies, 13%), and the United Kingdom (7 studies, 11%). Median sample size was 100 (interquartile range [IQR] 41.5–279). The majority of the studies (40, 66%) had pragmatic objectives. The median number of times cited overall was 69 (IQR 20.5–193). The combined median CONSORT score was 36 (IQR 27.5–39). Blinding was most deficiently reported. Other areas with a relatively low quality of reporting were sample size calculation (34.2% of surgical, 38.5% of drug, and 20% of device studies), allocation concealment (28.9% of surgical, 23.1% of drug, and 50% of device studies), and protocol implementation (18.4% of surgical, 23% of drug, and 20% of device studies). The quality of reporting did not correlate with the study impact. All studies had a median Jadad score ≤ 3. Thirty-three pragmatic studies (83%) and 5 explanatory studies (25%) met the design objectives. All pragmatic studies based on drug and device trials met their objectives, while 74% of pragmatic surgical trials met their objectives. CONCLUSIONS The prevalence of neurosurgical RCTs is low. The quality of RCT design and reporting in neurosurgery is also low. Many study designs are not compatible with stated objectives. Pragmatic studies were more likely to meet design objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting.

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