Consolidated Standards Of Reporting Trials Score Research Articles

Assessment of reporting quality of randomized controlled trials investigating the effects of inulin-type fructans supplementation on cardiovascular disease risk factors: A systematic survey.

Transparent and detailed reporting of randomized controlled trials (RCTs) is essential to judge its validity and generalizability. We assessed the reporting quality of RCTs examining the effects of inulin-type fructans supplementation on cardiovascular risk factors, before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) in 2010. We searched MEDLINE, EMBASE, Emcare, AMED, the Cochrane Library, and CINAHL from inception to May 15, 2022, including the reference lists of selected RCTs. We screened titles and abstracts and extracted the data independently and in duplicate. We included RCTs that investigated the effects of inulin-type fructans on cardiovascular disease risk factors (e.g., low-density lipoprotein cholesterol, triglycerides, fasting blood glucose) in adults (18 years or older). The primary outcomes of this study were: the overall reporting quality of RCTs (defined as the total number of items [0 to 36] present from the CONSORT checklist) published before and after CONSORT; and the study characteristics (e.g., sample size, significance of primary outcome) predictive of the CONSORT score. The secondary outcome was the reporting of each specific item of the CONSORT checklist during pre- and post-CONSORT periods. The mean difference in the total number of reported items in studies published before and after CONSORT were compared using a t-test and Poisson regression to explore the factors associated with overall reporting quality of RCTs. We used Fisher's exact test to compare the adherence to each of the 36 items during pre- and post-CONSORT periods. We identified 1,767 citations from our systematic search, of which 55 were eligible. There was a significant increase in the reporting of CONSORT items (mean difference 8.5, 95% confidence interval [CI] 5.24 to 11.71) between studies published before and after publication of CONSORT. The sole variable that was predictive of better reporting quality of RCTs was whether the study was published before or after CONSORT (incidence rate ratio 1.67, 95% CI 1.40 to 2.02). Completeness of reporting of RCTs only improved in 15 out of 36 items (41.6%) after the publication of CONSORT. The completeness of reporting in RCTs investigating inulin-type fructans supplementation on cardiovascular disease risk factors remains inadequate after the publication of CONSORT. Greater adherence to CONSORT by authors and enforcement of CONSORT by journals may improve the quality of reporting among RCTs.

Abstract 16310: Adherence of Randomized Controlled Trials in Heart Failure to Consort Reporting Standards

Introduction: Randomized control trials (RCTs) have changed care in Heart Failure (HF), but the reliability of results is contingent on trial validity and transparent reporting. The Consolidated Standards of Reporting Trials (CONSORT) checklist was developed in 1996 and subsequently updated to guide the design and reporting of RCTs, but the adherence of HF RCTs to CONSORT remains poorly understood. This study sought to evaluate the adherence of HF RCTs to the CONSORT 2010 update and to examine temporal trends in trial reporting in HF trials. Methods: We searched MEDLINE, EMBASE and CINAHL for HF RCTs in high-impact journals between 2000 and 2020. The primary outcome measure was RCT CONSORT statement or CONSORT extension reporting presented as mean CONSORT score. Descriptive statistics were calculated for CONSORT scores. We used the Jonckheere-Terpstra test to examine temporal trends and employed multivariable linear regression to evaluate the association between prespecified trial characteristics and the mean CONSORT score. Results: There were 221 RCTs, and mean CONSORT score was 69.7% (SD 11.5). Adherence to CONSORT reporting standards improved from 61.5% (SD 11.1) in 2000-2003 to 76.5% (SD 8.8) in 2016-2020 ( P <.001). Adherence was greater in two-group parallel individual-level RCTs (β =6.22 95% CI: 3.14, 9.30; P <.001) than in other trial types. Drug (β= -3.91, 95% CI: -7.32, -0.50; P <.001) and device/surgical (β= -2.82 (95% CI: -7.56, 1.93; P <.001) interventions were associated with lower adherence to CONSORT reporting standards than other interventions, while publication after 2010 was associated with greater adherence (β=10.96, 95% CI: 8.37, 13.55; P <.001). Funding source did not appear to have an association with adherence (β=1.51, 95% CI: -1.53, 4.55; P =.33). Conclusions: Among HF RCTs published in high-impact journals, adherence to CONSORT reporting standards has improved over time, but remains variable and suboptimal overall.

How well do orthodontic RCTs comply with CONSORT guidelines?

To assess the changes in compliance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized controlled trials (RCTs) in four orthodontic journals. To assess whether reporting of randomization, concealment, and blinding has improved. Electronic hand searching was undertaken to identify orthodontic RCTs published in four orthodontic journals from January 2016 to June 2017 (T1) and from January 2019 to June 2020 (T2). The journals were the American Journal of Orthodontics and Dentofacial Orthopaedics (AJO-DO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO), and Journal of Orthodontics (JO). Each item on the CONSORT checklist was scored as either reported, not reported, or not applicable for each paper reporting an RCT. The study included 69 papers reporting an RCT published in T1 and 64 RCTs published in T2. The median CONSORT score in T1 was 48.7% (interquartile range [IQR] 27.6%, 68.6%) and 67% in T2 (IQR 43.9%, 79.5%). This increase was statistically significant (P = 0.001) and largely attributable to improved reporting in AO (P = 0.016) and EJO (P = 0.023). Reporting did not change significantly in AJO-DO (P = 0.13) or in JO (P = 1.0). Reporting of random allocation sequence generation (OR 2.09; 95% CI 1.01, 4.29) and concealment of allocation (OR 2.27%, 95% CI 1.12, 4.57) were significantly higher in T2 compared with T1. Reporting of blinding did not change significantly. Overall reporting of CONSORT items in reports of orthodontic RCTs published in the AJO-DO, AO, EJO, and JO, improved significantly from 2016-17 to 2019-20. This could be improved further by authors, journal referees, and editors adhering to the guidelines.

What is the quality of reporting in randomized controlled trials in spinal conditions.

Substandard quality across published randomized controlled trials (RCTs) is a major concern. Imperfect reporting has the potential to distort the evidence landscape and waste valuable health-care resources. In this study, we aim to assess the current quality of reporting in the field of spine using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist. A list of published RCTs in the field of spine disease from January 1, 2013, to December 31, 2020, was built. Two reviewers scored the published RCTs against a modified CONSORT checklist. The mean adjusted CONSORT scores for each study, reporting category, and checklist item were calculated. The mean and median scores across all of the RCTs were 0.72 and 0.74 out of 1.00, respectively. The spectrum of scores was wide, ranging from 0.45 to 0.94. The reporting categories with the lowest score included randomization, blinding, and abstract. The items which were most under-reported included allocation sequence generation, type of randomization used, full trial protocol details, and abstract methodology. The inter-rater reliability between our reviewers was substantial (κ = 0.7, κ = 0.71). Our findings correlate with only a moderate level of compliance to the CONSORT criteria on the quality of reporting for RCTs in spinal conditions. This is in line with previous reports on compliance, both within and outside the field of spinal conditions. Further continued and sustained efforts are still required to enhance the quality and consistency of RCT reporting, ultimately reducing health-care resource wastage and improving patient safety.

Pharmacologic Treatments in Upper Extremity Complex Regional Pain Syndrome: A Review and Analysis of Quality of Evidence.

The purpose of this study was to assess the quality of evidence informing on common pharmacologic modalities used in upper extremity complex regional pain syndrome (CRPS). A literature search was performed for primary prospective trials that reported on the pharmacologic treatment of CRPS type I and II specific to the upper extremity. Thirty-one trials were included and evaluated by 2 independent reviewers according to the Oxford Levels of Evidence (LOE), modified Coleman Methodology Score, and the revised Consolidated Standards of Reporting Trials (CONSORT) score. Cohen's kappa coefficient was calculated to measure interrater reliability. Twenty-two Oxford LOE I and 9 level II trials met the inclusion criteria. Overall, there was high interrater reliability in the Oxford LOE (100% agreement), modified Coleman Methodology Score (87% agreement), and CONSORT score (94% agreement). The pharmacologic interventions with the highest quality of evidence supporting use in treatment of upper extremity CRPS were bisphosphonates and ketamine. Interventions that lack high-quality evidence are tricyclic antidepressants (TCAs) and topical dimethyl sulfoxide (DMSO). Pharmacologic agents that remain inconclusive are calcitonin, gabapentin, mycophenolate, probiotics, steroids, nonsteroidal anti-inflammatory drugs, vitamin C, and N-acetylcysteine. Agents with limited benefit are mannitol, isosorbide dinitrate, guanethidine, and morphine. Based on the evidence evaluated in this study, bisphosphonates should be considered as a first-line medication in the treatment of CRPS. In patients presenting with chronic or refractory CRPS, strong consideration should be given for the use of ketamine. Adjunct treatment in the acute setting should include TCAs and/or topical DMSO.

An Analysis of the Evidence Underpinning the American Academy Orthopaedic Surgery Pediatrics Clinical Practice Guidelines.

Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations. We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010. Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test. Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.

Analysis of the Quality of Prospective Randomized Controlled Trials for Treatment of Boxer's Fractures.

This study aimed to review level I and II therapeutic studies on boxer's fractures to measure variation in quality among the highest level study designs. We used quantitative measures of study quality to evaluate prospective randomized controlled trials (RCTs) of treatments of boxer's fractures. A search of PubMed, using terms "boxer's fracture" and "fifth metacarpal neck fracture" identified 164 articles from 1961 to 2019. From this list, we identified 6 RCTs. Two observers classified each trial according to 3 systems: the Oxford Levels of Evidence, the modified Coleman Methodology Score, and the revised Consolidated Standards of Reporting Trials (CONSORT) score. The 2 reviewers were consistent in their use of the Oxford Levels of Evidence (100% agreement). The differences between the average modified Coleman Methodology scores and the average CONSORT scores assigned by the 2 observers were not significant (46.2 vs 45.3 points, κ = 0) and (13.7 vs 14.3 points, κ = 0.33), respectively. Both observers rated all the studies as level I and as unsatisfactory according to the Coleman Methodology Score (100% and 100%), and less than half as unsatisfactory according to the CONSORT score (50% and 17%). Areas of deficiency included randomization, blinding, group comparability, clinical effect measurements, and allocation into treatment arms. Classifying orthopedic scientific reports according to the levels of evidence implies a degree of respect for level I and II studies that may not always be merited. Our data suggest that the quality of higher level studies, namely those involving boxer's fractures, varies and may often be unsatisfactory when critically evaluated.

Adherence to the CONSORT statement and extension for nonpharmacological treatments in randomized controlled trials of bariatric surgery: A systematic survey.

Reporting is critical for establishing the value of randomized controlled trials (RCTs). This study evaluated the adherence of bariatric surgery RCT reporting to the CONsolidated Standards Of Reporting Trials (CONSORT) statement 2010 and its 2017 extension for non-pharmacologic treatments (NPT extension). We identified all RCTs comparing bariatric surgery with conservational therapy or alternative bariatric surgery up to June 30, 2020. Reporting quality was assessed using criteria developed from the CONSORT statement and the NPT extension and scored as a percentage. The factors associated with reporting quality were explored by univariate and multivariate analysis. In total, 102 RCTs of bariatric surgery were included. The median scores according to the CONSORT statement and NPT extension were 63.3 and 26.8 of a maximum possible 100, respectively. Two-thirds of NPT extension items were reported in less than 25% of the RCTs. The median score improved over time for the CONSORT statement but not the NPT extension. A higher CONSORT score was associated with publication in core clinical journals, protocol registration, and funding. No factors associated with the NPT extension score were identified. Substantial efforts are warranted from authors, journals, registration platforms, and funders to overcome the flaws in the reporting of bariatric surgery RCTs.

Improved quality of reporting safety data of medication in paediatric randomised controlled trials

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event...

The reporting quality of randomized controlled trials and experimental animal studies for urethroplasty.

To assess the reporting quality of randomized controlled trials and experimental animal studies examining urethroplasty in reconstructive urological surgery literature. We performed a comprehensive literature search to identify all urethroplasty-related RCTs examining humans as well as animal models. We used the Consolidated Standards ofReportingTrials (CONSORT) and the Animals in Research: Reportingin vivoExperiments (ARRIVE) guidelines to assess reporting quality. Two reviewers performed data abstraction independently and in duplicate. We then generated descriptive statistics including CONSORT (0-25) and ARRIVE (0-20) summary scores using the median and interquartile range. Twenty studies were ultimately included; 14 randomized controlled trials and 6 experimental animal studies. All studies were two-armed, parallel group studies. Median sample sizes (and interquartile range) of the human and animal studies were 48.5 (31.8-53.8) and 18 (15.3-27.5), respectively. The median CONSORT and ARRIVE scores were 10.0 (8.75-12.63) and 7.97 (6.79-8.64), respectively. Human randomized controlled trials did not consistently report the method of allocation concealment (6/14; 42.9%), blinding (2/14; 14.3%), or discuss the generalizability of the results (6/14; 42.9%). Animal studies infrequently reported why a given animal model was used (1/6; 16.7%), how they were allocated to groups (0/6; 0%) or what the experimental primary and secondary outcomes were (0/6; 0%). Urethroplasty literature is marked by a paucity of both randomized controlled trials and experimental design animal studies. The existing studies are inconsistently reported and are therefore of uncertain methodological quality.

Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Safety Outcomes in Trials of Medical Cannabis and Cannabis-based Medicines for Chronic Noncancer Pain: A Systematic Review.

Current treatments for chronic pain have limited effectiveness and tolerability. With growing interest in the potential of cannabinoids, there is a need to inform risk-benefit considerations. Thus, this focused systematic review assesses the quality of safety assessment and reporting in chronic noncancer pain cannabinoid trials. The protocol for this review has been published, and, registered in PROSPERO. We searched MEDLINE, Embase, The Cochrane Library, Scopus, and PsychINFO for double-blind, placebo-controlled, randomized controlled trials of cannabinoids for chronic pain, with a primary outcome related to pain. The primary review outcome is adherence to the 2004 Consolidated Standards of Reporting Trials (CONSORT) Harms extension. Secondary outcomes included type, reporting method, frequency and severity of adverse events (AEs), trial participant withdrawals, and reasons for withdrawals. In total, 43 studies (4436 participants) were included. Type of cannabinoid (number of studies) included nabiximols (12), dronabinol (8), nabilone (7), oral cannabis extract preparations (5), smoked tetrahydrocannabinol (5), vaporized tetrahydrocannabinol (3), novel synthetic cannabinoids (2), sublingual cannabis extract preparations (1). The median CONSORT score was 7. On average, 3 to 4 recommendations of the CONSORT guidelines were not being met in trials. Seventeen trials did not provide their method of AE assessment, 14 trials did not report on serious AEs and, 7 trials provided no quantitative data about AEs. Better harms assessment and reporting are needed in chronic pain cannabinoid trials. Improvements may be achieved through: expanded education/knowledge translation increased research regulation by ethics boards, funding agencies and journals, and greater emphasis on safety assessment and reporting throughout research training.

Quality assessment of randomized controlled trial abstracts on drug therapy of periodontal disease from the abstracts published in dental Science Citation Indexed journals in the last ten years.

Background Randomized controlled trials (RCTs) provide the highest level of evidence and are likely to influence clinical decision-making. This study evaluated the reporting quality of RCT abstracts on drug therapy of periodontal disease and assessed the associated factors. Material and Methods The Pubmed database was searched for periodontal RCTs published in Science Citation Indexed (SCI) dental journals from 2010/01/01 to 2019/07/17. Information was extracted from the abstracts according to a modified Consolidated Standards of Reporting Trials (CONSORT) guideline checklist. The data was analyzed using descriptive statistical analysis and the statistical associations were examined using the linear regression analysis (P <0.05). Results This study retrieved 1715 articles and 249 of them were finally included. The average overall CONSORT score was 15.6 ± 3.4, which represented 40.9% (±0.6) of CONSORT criteria filling. The reporting rate of some items (trial design, numbers analyzed, confidence intervals, intention-to-treat analysis or per-protocol analysis, harms, registration) was less than 30%. The adequate reporting rate of some items (participants, randomization, numbers analyzed, confidence intervals, intention-to-treat analysis or per protocol analysis) was no more than 4%. None of the abstracts reported funding. According to the multivariable linear regression results, number of authors (P=0.030), word count (P <0.001), continent (P=0.003), structured format (P <0.001), type of periodontal disease (P <0.001) and international collaboration (P=0.023) have a significant association with reporting quality. Conclusions The quality of RCT abstracts on drug therapy of periodontal disease in SCI dental journals remained suboptimal. More efforts should be made to improve RCT abstracts reporting quality. Key words:s, RCT, drug therapy, periodontal disease, CONSORT, reporting quality assessment.

Quality assessment of randomized controlled trials of Iranian traditional medicine: An eight-year study

IntroductionIranian traditional medicine (ITM) has a long history that dates back to a thousand years ago. In recent years, quantity of scientific productions in this field have significantly grown, but there are no reviews of randomized controlled trials (RCT) conducted in this field and their quality has not been assessed. In this review, we evaluated the quality of RCTs in ITM between 2010 and 2017. MethodsA systematic online search was done in national and international databases between 2010 and 2017. Inclusion criteria were: RCTs investigating some aspect/s of ITM. Nnon-randomized trial designs, animal experiments, reviews and meta-analyses, conference abstracts, short communications, editorials, letters and case reports or case series were excluded. Quality assessment of each RCT was conducted using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane risk of bias tool. ResultsFrom 9568 records initially retrieved, only 151 RCTs remained eligible and were included in the study. The number of RCTs increased during 2010–2017, with a mean annual growth rate of 63 %. Based on the Cochrane Collaboration’s tool, most studies (51 %) were at moderate risk of bias. The mean (SD) CONSORT score for all items was 1.25(0.46, ranging from 0 to 2). Mean scores were low for some key items related to methodology. ConclusionDespite the significant increase in the number of RCTs conducted between 2010 and 2017 and some improvements in the quality of reporting, no improvement was observed in the trial methodology. Shortcomings in the methodology of trials can be overcome by further adherence to CONSORT statement.

Adherence of Randomized Controlled Trials to Consolidated Standards of Reporting Trials 2010 Guidelines: A Survey of Randomized Controlled Trials Published in 2011-2016 in 3 Periodontology Journals

ObjectiveTo assess the quality of reporting of randomized controlled trials (RCTs) in the Journal of Clinical Periodontology (JCP), Journal of Periodontology (JOP), and Journal of Periodontal Research (JPR), published in the years 2011 until 2016, using Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. MethodsA thorough search of PubMed for RCTs published between January 2011 and December 2016 in the three journals was carried out. The CONSORT 2010 checklist (36 questions) was used to evaluate the adherence of these RCTs to these guidelines. A modified CONSORT score was calculated and categorized as “perfect” (100%), “excellent” (80%-99%), “good” (60%-79%), “modest” (40%-59%), and “poor” (<40%). ResultsA total of 369 RCTs were published in the three periodontology journals from 2011 until 2016. Based on the modified CONSORT score among all the RCTs, title, abstract, and introduction sections of the included RCTs showed good adherence to the CONSORT 2010 guidelines (60%-79%), whereas the adherence was poor for half the items in methodology (<40%), results (<40%), and discussion (40%). The highest modified CONSORT score was obtained for the trials published in the JCP from 2011 to 2016, whereas the lowest score was achieved by the RCTs in the JPR. Overall, none of the RCTs in any of the journals were perfect in reporting the trials as per the guidelines. Almost half of the RCTs in the JCP showed good adherence (51.1%), whereas almost three-fourths of the RCTs in the JOP (72%) and JPR (82.7%) showed modest to poor adherence as per the reporting guidelines (P < .001). ConclusionAmong the three periodontology journals assessed, the JCP showed better adherence than the JOP and JPR from 2011 until 2016.

849P - Quality of docetaxel toxicity reporting for castration resistant prostate cancer (CRPC): A systematic review

Background: Prostate cancer trial design is structured following the Prostate Cancer Clinical Trials Working Group (PCWG) guidelines which focus on harmonization of inclusion criteria and outcome data. The PCWG, however, does not provide clear outlines for reporting of safety data. In fact, there is a perceived lack of widely accepted guidelines for safety reporting. Methods: A PubMed search of phase II and III clinical trials published until 2015 (included) was conducted using keywords “prostate cancer” and “docetaxel.” Docetaxel-naïve CRPC patients who received 75 mg/m2 docetaxel monotherapy every three weeks were included. To assess quality of toxicity reporting, the Consolidated Standards of Reporting Trials (CONSORT) harms checklist was adapted and each trial scored by two independent reviewers. CONSORT scores as well as PSA and radiological response rates over time were examined with Spearman correlation coefficients. Univariable and multivariable linear regression examined associations between scores and phase II versus III trials, publication year, midpoint of accrual, number of patients, sponsor type, journal impact factor, presence of supplementary data, and geographical region. Results: From 21 clinical trials including 5,460 patients in docetaxel monotherapy arms, the median CONSORT score was 15.3 (IQR 13.7–16.5) out of 22. Correlation coefficients were not significant for all comparisons of CONSORT scores and response rates versus years of accrual or year of publication. In univariable linear regression, phase III clinical trials were associated with a significantly higher CONSORT score (p = 0.01) as was a journal impact factor greater than 15 (p = 0.02). In exploratory analyses, none of the examined factors were significant in multivariable linear regression. Conclusions: CONSORT scores and thus toxicity reporting quality in CRPC trials studying docetaxel show need for improvement and should be subject to further discussion. There has been no significant improvement in toxicity reporting quality over time. It remains to be studied if our findings also apply to other agents used for the treatment of CRPC. Legal entity responsible for the study: Sunnybrook Research Institute. Funding: Joseph and Silvana Melara Cancer Fund. Disclosure: All authors have declared no conflicts of interest.

The impact of STRICTA and CONSORT on reporting of randomised control trials of acupuncture: a systematic methodological evaluation

BackgroundClear and unambiguous reporting is essential for researchers and clinicians to be able to assess the quality of research. To enhance the quality of reporting, consensus-based reporting guidelines are commonly...

Compliance of Randomized Clinical Trials in Noncarious Cervical Lesions With the CONSORT Statement: A Systematic Review of Methodology

The literature was reviewed to evaluate the compliance of randomized clinical trials (RCTs) with the CONsolidated Standards of Reporting Trials (CONSORT ) and the risk of bias of these studies through the Cochrane Collaboration risk of bias tool (CCRT). RCTs were searched at Cochrane Library, PubMed, and other electronic databases to find studies about adhesive systems for cervical lesions. The compliance of the articles with CONSORT was evaluated using the following scale: 0 = no description, 1 = poor description, and 2 = adequate description. Descriptive analyses about the number of studies by journal, follow-up period, country, and quality assessments were performed with CCRT for assessing risk of bias in RCTs. One hundred thirty-eight RCTs were left for assessment. More than 30% of the studies received scores of 0 or 1. Flow chart, effect size, allocation concealment, and sample size were more critical items, with 80% receiving a score of 0. The overall CONSORT score for the included studies was 15.0 ± 4.8 points, which represents 46.9% of the maximum CONSORT score. A significant difference among countries was observed ( p<0.001), as well as range of year ( p<0.001). Only 4.3% of the studies were judged as at low risk; 36.2% were classified as having unclear risk and 59.4% as having high risk of bias. The adherence of RCTs evaluating adhesive systems to the CONSORT is low with unclear/high risk of bias.

Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely.

Quality of Randomized Controlled Trials Reporting in the Treatment of Adult Patients with High-Grade Gliomas

The randomized controlled trial (RCT) is the gold standard to objectively assess the effect of treatments. To help improve the quality of RCTs, experts established a list of recommendations, the CONsolidated Standards of Reporting Trials (CONSORT) Statement. In this study, we evaluated the implementation of the CONSORT Statement in the field of high-grade gliomas in adult patients and looked for criteria associated with higher quality of RCTs. We searched all high-grade gliomas RCTs published in PubMed between January 1990 and December 2016. The quality of these RCTs was assessed by completing a modified CONSORT Score (CS). Ninety-six published RCTs were identified. The median CS was 19.5 on a scale of 0-33. Items were not equally reported. Items regarding the method of randomization or the blinding were reported in less than 25% of RCTs. However, the CS has constantly improved over the years. Before the implementation of the CONSORT Statement in 1996, the median CS was 13, whereas it was 17 for the period 1996-2004 and 22 after 2005. A higher CS was observed when RCTs were published in a journal with an impact factor above 10 (p < .001) or after 2010 (p = .001), when the primary outcome was clearly defined (p < .001) and for RCTs that enrolled more than 200 patients (p = .004). Although there has been a steady improvement in the CS over the years in the field of high-grade gliomas, a major effort must be made in the reporting methods for randomization and blinding. This study showed that the quality of reporting of randomized control trials (RCTs) concerning the treatment of high-grade gliomas is poor. Factors associated with a better quality of reports were identified and should be incorporated into the design of future RCTs. When clinicians read the results of RCTs, they should be aware of the possible inadequate reporting from these trials and take it into account for the management of their patients. This study identifies how RCTs can be improved in their reporting but also in their design, in order to advance care for patients with high-grade gliomas in the future.

P09.58 Quality of randomized controlled trials reporting in the treatment of adult high grade gliomas

Abstract Introduction: Randomized Controlled Trial (RCTs) is the gold standard to objectively assess the effect of a treatment. The RCTs methodology must be particularly rigorous to achieve strong evidence of efficiency. To help improve the quality of RCTs, a group of experts established a list of recommendations, adopted by most international journals, called the CONSORT (CONsolidated Standards of Reporting Trials) Statement. First published in 1996, it was actualised in 2001 and 2010. In this study, we assessed the implementation of the CONSORT Statement criteria in the field of adult high grade gliomas. We also aimed to identify criteria associated with higher quality of RCTs. METHODS: We searched PUBMED to retrieve all RCTs concerning high grade gliomas published between the 1st January 1990 and the 1st March 2016. The quality of these RCTs was assessed by completing a modified CONSORT Score containing 33 items. This work was done independently by two investigators and every discordance was resolved by consensus. We also extracted data that seemed relevant to assess the quality of RCTs. Results: Eighty-four published RCTs were identified. The median CONSORT Score was 19 (range: 3-30). Items were not equally reported and items regarding the method of randomization, the blinding or the accessibility of the protocol were reported in less than 25% of RCTs which could raise important biases and led to inappropriate interpretation of the results. However, the CONSORT Score constantly improved over the years. Before the onset of the CONSORT Statement in 1996, the median CONSORT Score was 13 (range: 4-19) whereas it was equal to 18 (range: 3-26) for the period 1996-2004 and equal to 22 (range: 6-30) after 2005. A higher CONSORT Score was observed when RCTs were published in journal with impact factor above 10 (24 vs 17, p<0.001). RCTs that enrolled more than 200 patients had a significantly higher CONSORT Score (20.6 vs 16.4, p=0.004). CONCLUSION: This study demonstrated a continuous improvement over the years of the CONSORT Score of published RCTs in the field of high grade gliomas. We identified three factors associated with a better report of RCTs: the date of publication, the impact factor of the journal and the number of patients included in the study.