scholarly journals Deficiencies in the reporting quality of RCTs in neurosurgery: How can we do better?

2015 ◽  
Vol 42 (S1) ◽  
pp. S12-S12
Author(s):  
A Mansouri ◽  
B Cooper ◽  
S Shin ◽  
D Kondziolka
Keyword(s):  
Sample Size Calculation ◽  
Reporting Quality ◽  
Allocation Concealment ◽  
High Yield ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Study Designs ◽  
Design Factors

Background: Deficiencies in design and reporting of randomized controlled trials (RCTs) limit their validity. The quality of recent RCTs in neurosurgery was analyzed to assess adequacy of design and reporting. Methods: A high-yield search of the MEDLINE and EMBASE databases (2000-present) was conducted. The CONSORT and Jadad scales were used to assess the quality of design/reporting. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman’s test was used to assess correlations. Regression analysis was used to assess associations. Results: Sixty-one articles were identified. Vascular was the most common sub-specialty (37%). The median CONSORT and Jadad scores were 36 (IQR 27.5-39) and 3 (IQR 2-3). Blinding, sample size calculation and allocation concealment were most deficiently reported. The quality of reporting did not correlate with the study impact. The majority of studies (83%) had pragmatic objectives; while pragmatic studies had compatible design factors, trials with explanatory objectives were less successful. Conclusions: The prevalence and quality of neurosurgical RCTs is low. Many study designs are not compatible with stated objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting. Alternative methodologies merit discussion.

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.

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

2017 ◽  
Vol 35 (2) ◽  
pp. 100-106 ◽  
Author(s):  
Jingchun Zeng ◽  
Guohua Lin ◽  
Lixia Li ◽  
Liming Lu ◽  
Chuyun Chen ◽  
...  
Keyword(s):  
Stroke Rehabilitation ◽  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Post Stroke ◽  
Randomised Controlled

Objectives To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Methods Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. Results A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items “Randomised’ in the title or abstract’, ‘Participants’, ‘Statistical methods’, ‘Recruitment’, ‘Baseline data’, and ‘Outcomes and estimation’, with positive rates >80%. However, the quality of reporting for the items ‘Trial design’, ‘Outcomes’, ‘Sample size’, ‘Allocation concealment’, ‘Implementation’, ‘Blinding’, ‘Flow chart’, ‘Intent-to-treat analysis’, and ‘Ancillary analyses’ was very poor with positive rates <10%. Based on STRICTA, the items ‘Number of needle insertions per subject per session’, ‘Responses sought’, and ‘Needle type’ had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. Conclusions The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review

2012 ◽  
Vol 30 (2) ◽  
pp. 210-216 ◽  
Author(s):  
Benoit You ◽  
Hui K. Gan ◽  
Gregory Pond ◽  
Eric X. Chen
Keyword(s):  
Systematic Review ◽  
Randomized Clinical Trials ◽  
Sample Size Calculation ◽  
Trial Registration ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Peer Reviewers ◽  
Over Time

Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P < .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P < .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.

scholarly journals Randomized Controlled Trials of Acupuncture (1997–2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument

2011 ◽  
Vol 2011 ◽  
pp. 1-25 ◽  
Author(s):  
Richard Hammerschlag ◽  
Ryan Milley ◽  
Agatha Colbert ◽  
Jeffrey Weih ◽  
Beth Yohalem-Ilsley ◽  
...  
Keyword(s):  
English Language ◽  
Assessment Tool ◽  
Geographical Origin ◽  
Reporting Quality ◽  
Inclusion Criteria ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Practitioner Training ◽  
Acupuncture Research

The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997–2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P<.001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n=5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.

scholarly journals Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

2018 ◽  
Vol 5 (1) ◽  
pp. 21
Author(s):  
Mahmood E. Elrggal ◽  
Morooj Al-Muwallad ◽  
Areej Al-Otaibi ◽  
Jomanah Alsiddik ◽  
Alaa Shahbar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Helicobacter Pylori ◽  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Randomised Controlled

<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>

Quality of Randomized Controlled Trials Reporting in the Primary Treatment of Brain Tumors

2006 ◽  
Vol 24 (7) ◽  
pp. 1136-1144 ◽  
Author(s):  
Rose Lai ◽  
Rong Chu ◽  
Michael Fraumeni ◽  
Lehana Thabane
Keyword(s):  
Brain Tumors ◽  
Regression Models ◽  
Reporting Quality ◽  
Primary Treatment ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Significant Factors

Purpose To assess the reporting quality of randomized controlled trials (RCTs) in the primary treatment of brain tumors and to identify significant predictors of quality. Patients and Methods Two investigators searched MEDLINE, EMBASE, and bibliographies of retrieved articles for RCTs in the primary treatment of brain tumors published between January 1990 and December 2004. We assessed the quality of overall reporting and key methodologic factors reporting (allocation concealment, blinding, and intention to treat [ITT]). Two investigators also rated articles independently using items from the revised Consolidated Standards of Reporting Trials statement. A generalized estimated equation was used to generate regression models that identified significant factors associated with quality of reporting. Results We retrieved 74 relevant RCTs that randomly assigned 14,498 brain tumor patients. The quality of overall reporting has improved during the last 15 years, but eight of the 15 methodologic items were reported in less than 50% of trials. In the appraisal of the reporting quality of key methodologies, allocation concealment, blinding, and adherence to the ITT principle were reported in less than 30% of articles. Multivariable regression models revealed that an impact factor more than 1.66, publication after 1995, and sample size more than 280 were significant factors associated with better overall reporting, whereas complete industrial funding, impact factors more than 2.64, and positive primary outcomes were predictors of higher ratings of the three most important methodologic qualities. Conclusion Despite improvement in general reporting quality, key methodologies that safeguard against biases may still benefit from better description. Significant factors associated with better reporting may act as surrogates for other characteristics.

scholarly journals Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

2011 ◽  
Vol 2011 ◽  
pp. 1-10 ◽  
Author(s):  
Jing-Yi Li ◽  
Yuan-Fen Zhang ◽  
Gordon S. Smith ◽  
Chuan-Jiang Xue ◽  
Yan-Nan Luo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Tai Chi ◽  
Randomized Clinical Trials ◽  
Reporting Quality ◽  
Evidence Base ◽  
Substantial Improvement ◽  
Allocation Concealment ◽  
Quality Of Reporting ◽  
Study Results

Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs) in the Tai Chi literature following the publication of the CONSORT guidelines in 2001.Data Sources. The OVID MEDLINE and PUBMED databases.Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i) it was an original report of the trial; (ii) its design was RCT; (iii) one of the treatments being tested was Tai Chi; and (iv) it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews.Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials.Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

scholarly journals Randomized Controlled Trials

2021 ◽  
Vol 2 (2) ◽  
Author(s):  
Nidhi Bhatia ◽  
Anju Grewal
Keyword(s):  
Controlled Trial ◽  
Research Question ◽  
Sample Size Calculation ◽  
Allocation Concealment ◽  
Randomised Control Trial ◽  
Sample Population ◽  
Random Allocation ◽  
Randomized Controlled ◽  
Comparison Groups ◽  
Study Designs

A randomized controlled trial (RCT) is a prospective, comparative, quantitative experiment/study that is performed under controlled conditions with random allocation of interventions to comparison groups. Among all the clinical study designs, evidence generated from RCTs is considered to be at top of the evidence pyramid. There are many different RCT designs and they can be classified on the basis of interventions evaluated, participants’ exposure and level of blinding. All RCTs should be planned prospectively, a research question should be formulated, sample population approached and informed consent obtained from participants of the trial. These consented subjects are randomly assigned to any of the study arms and the changes are then measured over time. The basic principles to designing an RCT include formulating a research question, developing a protocol, randomization, allocation concealment, blinding, sample size calculation and registering of RCTs. Appropriate guidelines for reporting RCTs should be followed and RCTs should only be conducted if they are ethically viable, economical and clinically worthwhile. Keywords: Randomised Control Trial (RCT)

scholarly journals Methodological reporting quality of randomized controlled trials in three leading sports medicine journals over 10 years

2020 ◽  
Author(s):  
Qian Chen ◽  
Qirong Zhou ◽  
Sihua Pan ◽  
Xin Zhi ◽  
Xiaoqun Li ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Sports Medicine ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Scientific Testing

Abstract Background Randomized controlled trials (RCTs) are the gold standard scientific testing for medical interventions. However, low-quality RCTs may provide misleading evidence. This research elucidated the methodological reporting quality of randomized controlled trials (RCTs) in three sports medicine journals over 10 years following the CONSORT statement. Methods and Findings In this study, we evaluated the methodological reporting quality of RCTs in three major sports medicine journals, including Journal of Science and Medicine in Sport, British Journal of Sports Medicine and Clinical Journal of Sports Medicine from 2008 to 2017. The methodological reporting quality, including the allocation sequence generation, allocation concealment, blinding, type of analysis, handling of dropouts were revealed. Number of patients, funding source, type of intervention and country were retrieved. The methodological reporting quality was descriptively reported. A total of 475 trials were involved and 166 (34.9%) trials reported adequate allocation generation, 124 (26.1%) trials reported adequate allocation concealment, 262(55.2%) trials reported adequate blinding, 122 (25.7%) trials reported type of analysis and 100 (21.1%) trials reported handling of dropouts. Conclusions This study shows that the methodological reporting quality of RCTs in the three major sports medicine journals were unsatisfactory and it can be further improved.

Quality of Randomized Controlled Trials Reporting in the Treatment of Sarcomas

2011 ◽  
Vol 29 (9) ◽  
pp. 1204-1209 ◽  
Author(s):  
Maud Toulmonde ◽  
Carine Bellera ◽  
Simone Mathoulin-Pelissier ◽  
Marc Debled ◽  
Binh Bui ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Quality Score ◽  
Controlled Trials ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Oncology Practice

PurposeRandomized controlled trials (RCTs) represent the best evidence in oncology practice. The aim of this study was to assess the reporting quality of sarcoma RCTs and to identify significant predictors of quality.Patients and MethodsTwo investigators searched MEDLINE for pediatric and adult bone and soft tissue sarcoma RCTs published between January 1988 and December 2008. The quality of each report was assessed by using a 15-point overall reporting quality score based on 15 items from the revised Consolidated Standards of Reporting Trials (CONSORT) statement (overall quality score [OQS] range, 0 to 15 points). Concealment of allocation, appropriate blinding, and analysis according to intention-to-treat principle were assessed separately because of their crucial methodologic importance by using a 3-point key methodologic index score (MIS; range, 0 to 3).ResultsWe retrieved 72 relevant RCTs that included 16,029 patients. The median OQS was 9.5. Allocation concealment, blinding, and analysis by intent to treat were reported only in 21 (29%), nine (12.5%), and 23 (32%) of the 72 RCTs, respectively. The median MIS was 1 with a minimum of 0 and a maximum of 2. On multivariate analysis, publication after 1996 and high impact factor remained independent and significant predictors of improved OQS. The sole variable associated with improved MIS was the publication of chemotherapy-only trials.ConclusionAlthough the overall quality of sarcoma RCTs reporting has improved over time, reporting of key methodologic issues remains poor. This may lead to biased interpretation of sarcoma trial results.

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