Consolidated Standards Of Reporting Trials Checklist Research Articles

Quality and completeness of, and spin in reporting of, pilot and feasibility studies in hip and knee arthroplasty: a protocol for a methodological survey

IntroductionPilot or feasibility trials examine the feasibility, viability and recruitment potential of larger, main trials. Specifically, a pilot trial can be instrumental in identifying methodological issues essential to the development...

Physicochemical and Biological Properties of Pulp Capping Agents: A Systematic Review of In Vitro Studies

Abstract Aim: The primary aim was to evaluate the physicochemical and biological characteristics of pulp capping materials. Materials and Methods: The systematic review report adhered to the latest Preferred Reporting Items for Systematic Reviews and Meta-Analysis statements, and the protocol was pre-registered (CRD42023471030) in the PROSPERO database before its commencement. To retrieve relevant literature, electronic searches were conducted using the Medline and Google Scholar databases from January 2000, up to August 2023. The records obtained through our electronic search were managed using a specialized web application for systematic review screening, and data were extracted using a standardized form. The evaluation of potential bias within the studies employed the modified Consolidated Standards of Reporting Trials (CONSORT) checklist specifically designed for reporting in vitro dental material research. Results: The results revealed that out of 255 identified records, 16 studies were included. An analysis based on the modified CONSORT checklist identified a moderate risk of bias in the included studies, with compliance scores ranging from 50% to 70%. Studies scoring below 50% were omitted from the discussion because of a higher risk of bias. Conclusion: This study concludes that the physicochemical properties of resin-incorporated materials are better than those of calcium silicate cement (CSCs). However, the biological properties of CSCs are superior to those of resin-incorporated materials.

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.

Clinical and immunological aspects of gingival retraction systems in fixed dental prostheses: A systematic review

Objective To describe the existing knowledge on the efficacy of the different gingival retraction systems (GRSs) in gingival displacement, to know their effects on biological functions of human gingival fibroblasts (HGFs), and on the expression of inflammatory mediators (TNF-α and MCP-1) in gingival crevicular fluid (GCF), and saliva. Methods The protocol used for this systematic review was registered in INPLASY: 202410005. A digital search was performed in the databases PubMed/MEDLINE, Scopus, Science Direct, Web of Science, and Google Scholar of the literature published in the English language in the last 17 years (from December 10th, 2006, to May 15th, 2023), and included retrospective randomized clinical studies, prospective, and in vitro experimental studies. In addition, PRISMA criteria were followed. The methodological validity of the selected articles was assessed using Joanna Briggs Institute (JBI) critical appraisal tool, and the modified Consolidated Standards of Reporting Trials checklist (CONSORT). Results 27 articles published between 2006 and 2023 were evaluated. Six hundred 32 subjects, aged between 18 and 65, participated in the clinical studies. 93.7% of the studies assessed periodontally healthy patients, and only 6.3% evaluated patients with mild gingivitis. Also, 882 teeth were samples, of which the majority were posterior teeth (54%). The most commonly used GRSs was aluminum chloride gingival retraction paste (74%). The GCF samples were taken in 67% of the studies, and ELISA was used in all studies (100%) to determine inflammatory mediators. The most frequently analyzed marker was TNF-α (67%). Conclusion The system Merocel Strips (Mystic, conn, USA) achieved the highest level of gingival displacement (1.66 ± 3.7 mm). In addition, the braided cords produced the lowest TNF-α levels (0.43 ± 0.08pg/mL). Astringent systems such as ferric sulfate had higher toxicity in HGFs.

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.

Authors arbitrarily used methodological approaches to analyze the quality of reporting in research reports: a meta-research study

ObjectivesMany authors used reporting checklists as an assessment tool to analyze the reporting quality of diverse types of evidence. We aimed to analyze methodological approaches used by researchers assessing reporting quality of evidence in randomized controlled trials, systematic reviews, and observational studies. Study Design and SettingWe analyzed articles reporting quality assessment of evidence with Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA), CONsolidated Standards of Reporting Trials (CONSORT), or the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) checklists published up to 18 July 2021. We analyzed methods used for assessing reporting quality. ResultsAmong 356 analyzed articles, 293 (88%) investigated a specific thematic field. The CONSORT checklist (N = 225; 67%) was most often used, in its original, modified, partial form, or its extension. Numerical scores were given for adherence to checklist items in 252 articles (75%), of which 36 articles (11%) used various reporting quality thresholds. In 158 (47%) articles, predictors of adherence to reporting checklist were analyzed. The most studied factor associated with adherence to reporting checklist was the year of article publication (N = 82; 52%). ConclusionThe methodology used for assessing reporting quality of evidence varied considerably. The research community needs a consensus on a consistent methodology for assessing the quality of reporting.

Assessment of Reporting Quality of Drug-Related Randomized Controlled Trials Conducted in India and Published in MEDLINE-Indexed Indian Journals Over a Decade: A Systematic Review.

Poorly published trials may result in biased and erroneous healthcare decisions. We conducted this systematic review to evaluate the reporting quality of drug-related randomized controlled trials (RCTs) conducted in India and published in MEDLINE-indexed Indian journals over a decade (between January 1, 2011, and December 31, 2020), as per the Consolidated Standards of Reporting Trials (CONSORT) Checklist 2010. An extensive literature search was conducted using the terms "Randomized controlled trial AND India." The full-length papers were extracted for RCTs related to drugs. Two independent investigators assessed each article against the checklist containing 37 criteria. Each article was scored 1 or 0 against each criterion which was finally summed up and evaluated. None of the articles fulfilled all 37 criteria. A compliance rate of >75% was seen in only 15.5% of articles. More than 75% of articles fulfilled a minimum of 16 criteria. Major checklist points observed to be deficient were "important changes to methods after trial commencement" (7%), "interim analysis and stopping guidelines" (7%), and "description of similarity of interventions while blinding" (4%). There remains ample room for improvement regarding research methodology and manuscript preparation in India. Moreover, journals should stringently implement the CONSORT Checklist 2010 to enhance the standard and quality of publications.

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.

Effectiveness of ergonomic interventions on work activity limitations in adults with rheumatoid arthritis: A systematic review.

Rheumatoid arthritis (RA) is one of the leading causes of work disability in the United States. Ergonomic interventions offer an individualized treatment approach, and when used in conjunction with pharmacological treatment interventions, may improve work outcomes and improve the overall quality of life for individuals with RA. To identify the current body of evidence regarding the effectiveness of ergonomic interventions in reducing work activity limitations in adults with RA. A systematic review was conducted to identify articles of ergonomic interventions targeting working adults with RA. The CONsolidated Standards of Reporting Trials (CONSORT) checklist and Non-Pharmacological Treatment (NPT) Extension evaluated the reporting quality of each randomized controlled trial (RCT), and the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) evaluated the quality of the evidence. Six studies were identified and reviewed for the quality of their reporting on evidence related to work activity limitations. Sixty-six percent of the items on the CONSORT checklist were fully reported by all studies and analysis through the GRADE framework demonstrated moderate confidence that the reported effects of ergonomic interventions on work activity limitations in the studies are accurate. This review revealed varied results for the effectiveness of ergonomic interventions on work activity limitations and at-work productivity. The results of this review indicate a need for further investigation. Future studies should focus on reviewing specific ergonomic interventions to determine the dosage needed to see results in reducing work activity limitations for working adults with RA.

Comparison of the effectiveness of 38% silver diamine fluoride and atraumatic restorative treatment for treating dental caries in a school setting: A randomized clinical trial.

Dental caries is an infectious microbial disease of the teeth, affecting mostly young children. It is caused by the interplay of numerous factors that are more common in susceptible and lower-income groups. Therefore, there is a dire need for a simple yet effective method of treating dental caries. The aim of the study was to compare the effectiveness of 38% silver diamine fluoride (SDF) and atraumatic restorative treatment (ART) in the treatment of dental caries in a school setting. A randomized clinical trial (RCT) using a parallel-group design was conducted among schoolchildren aged 6-12 years. Oral hygiene practices and sugar exposure were recorded at baseline. In the schoolchildren, 190 dental caries lesions were restored using 38% SDF (group 1) or ART (group 2). The χ 2 test and the Kaplan-Meier survival analysis were done to assess the 2 treatment modalities. The RCT was carried out and reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) checklist. A total of 190 children fulfilled the inclusion criteria and the mean age of the study population was 9.3 ±1.3 years. The majority of the participants brushed their teeth once daily, using a toothbrush, rinsed their mouth after meals and had optimal sugar exposure. In measuring the outcome of the interventions after 9 months, 58.9% of the participants from group 1 had their restorations intact as compared to 47.8% in group 2, and this was found to be statistically significant (p = 0.004). The survival analysis using the log rank test showed 38% SDF to be better in comparison with ART. This study indicated that SDF was better at arresting caries, and hence it can be considered a viable treatment option in areas with limited access to oral healthcare.

Effectiveness of Ergonomic Interventions on Work Activity Limitations in Adults with Rheumatoid Arthritis: A Systematic Review

<h3>Research Objectives</h3> Rheumatoid arthritis (RA) is one of the leading causes of work disability in the United States. Ergonomic interventions offer an individualized treatment approach, and when used in conjunction with pharmacological treatment interventions, may improve work outcomes and improve the overall quality of life for individuals with RA. To identify the current body of evidence regarding the effectiveness of ergonomic interventions in reducing work activity limitations in adults with RA. <h3>Design</h3> A systematic review was conducted to identify articles of ergonomic interventions targeting working adults with RA. The CONsolidated Standards of Reporting Trials (CONSORT) checklist and Non-Pharmacological Treatment (NPT) Extension evaluated the reporting quality of each randomized controlled trial (RCT), and the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) evaluated the quality of the evidence. <h3>Setting</h3> N/A. <h3>Participants</h3> N/A. <h3>Interventions</h3> N/A. <h3>Main Outcome Measures</h3> N/A. <h3>Results</h3> Six studies were identified and reviewed for the quality of their reporting on evidence related to work activity limitations. Sixty-six percent of the items on the CONSORT checklist were fully reported by all studies and analysis through the GRADE framework demonstrated moderate confidence that the reported effects of ergonomic interventions on work activity limitations in the studies are accurate. This review revealed varied results for the effectiveness of ergonomic interventions on work activity limitations and at-work productivity. <h3>Conclusions</h3> The results of this review indicate a need for further investigation. Future studies should focus on reviewing specific ergonomic interventions to determine the dosage needed to see results in reducing work activity limitations for working adults with RA.

A Cross-sectional literature survey showed the reporting quality of multicenter randomized controlled trials should be improved

ObjectiveTo assess the reporting quality of randomized controlled trials (RCTs) with multicenter design, particularly whether necessary information related to multicenter characteristics was adequately reported. Study Design and SettingThrough a search of 4 international electronic databases, we identified multicenter RCTs published in English from 1975 to 2019. Reporting quality was assessed by the CONSORT (Consolidated Standards of Reporting Trials) checklist (37 items) and by a self-designed multicenter-specific checklist (27 items covering multicenter design, implement and analysis). The scores of trials published in three time periods (1975-1995; 1996-2009; and 2010-2019) were also compared. ResultsA total of 2,844 multicenter RCTs were included. For the CONSORT checklist, the mean (standard deviation) reporting score was 24.1 (5.5), 12 items were assessed as excellent (>90%), 12 items as good (50%-90%), and 13 items as poor (<50%). For the multicenter checklist, the reporting score was 3.9 (2.2), only 3 items were excellent or good, and the remaining 24 items were poor. Time period comparison showed that reporting quality improved over time, especially after the CONSORT 2010 issued. ConclusionAlthough CONSORT appears to have enhanced the reporting quality of multicenter RCTs, further improvement is needed. A “CONSORT extension for multicenter trials” should be developed.

Adherence to the Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Randomized Controlled Trials Related to Mandibular Third Molars

Randomized controlled trials (RCTs) are the backbone of evidence-based medicine. Despite the widespread acceptance of the Consolidated Standards of Reporting Trials (CONSORT), its use for reporting clinical trials in journals remains poor. The purpose of this study was to find out to what extent RCTs related to mandibular third molars have adhered to the CONSORT statement. This study was carried out during April 2020 to June 2020. PubMed was used to retrieve RCTs related to mandibular third molars conducted during the last 5years. The search terms used were mandibular third molar OR lower third molar OR impacted mandibular third molar AND randomized controlled trial. Each article was assessed for adherence to the CONSORT statement. Eighty unique articles were retrieved. The mean percentage adherence to the CONSORT statement noted was 60.26%. Of the 37 CONSORT items, only 4 items showed 100% adherence (2a, 2b, 4a, and 12a). The most underreported items were #10, 12b, 17a, 17b, 18, 19, 23 to 25. Of the 23 journals considered, 6 journals did not recommend CONSORT for reporting RCT in the "Instructions to Authors" guidelines. Within the limits of the study, it is clear that the RCTs related to third molar do not show 100% adherence to the CONSORT checklist. The editorial policy, peer reviewers, and researchers should endorse the use of the CONSORT checklist for transparent reporting of the RCTs.

Reporting quality of abstracts of veterinary randomized controlled trials.

To evaluate the adherence of veterinary randomized controlled trial (RCT) abstracts to the recommendations on minimum abstract information included in the Consolidated Standards of Reporting Trials (CONSORT) checklist for RCT abstracts and to identify characteristics associated with the number of CONSORT items reported. 212 abstracts representing all RCTs published in 5 general veterinary journals in 2013 and 2018. 2 investigators independently assessed whether each of the 15 CONSORT checklist items for abstracts applicable to veterinary medicine was reported. Generalized linear mixed models were built to explore associations of selected variables with the total number of checklist items reported. Abstracts included a median of 5 checklist items (range, 2 to 10 items). None met the recommendations for reporting participant recruitment and funding source. Less than 25% of abstracts met the recommendations for the title, participant eligibility criteria, primary outcome, randomization technique, blinding, numbers analyzed, primary outcome results, and harms to participants. The number of items reported was higher in abstracts of RCTs that included clinical patients (vs other participants; OR, 1.13; 95% CI, 1.05 to 1.22). The number of items reported did not significantly change over time. Results suggested that the reporting quality of abstracts of RCTs in general veterinary journals was suboptimal per CONSORT recommendations. Because abstracts may be the only reference material available in certain settings, improvements are warranted to ensure readers have the information they need to properly interpret reported findings.

Quality of prospective controlled randomized trials regarding platelet-rich plasma injection for osteoarthritis of the knee

BackgroundRandomized controlled trials (RCTs) are the gold standard for study design and are considered to have the highest level of evidence. The purpose of this study is to evaluate quality of evidence of prospective RCTs that investigated the clinical efficacy of platelet-rich plasma (PRP) treatments for knee osteoarthritis. We hypothesized that a high level of clinical evidence does not correlate with a high-quality scientific study. Material and methodsA systematic literature search to identified RCTs that evaluated the efficacy of PRP treatments for knee osteoarthritis. Inclusion criteria included studies that contained key terms “Platelet-rich plasma,” “PRP”, “knee”, and “osteoarthritis”. Exclusion criteria excluded studies that were not prospective RCTs. Ten RCTs were evaluated by four independent reviewers. The studies were assessed according to the Oxford Levels of Evidence, a modified Coleman Methodology Score, and the revised Consolidated Standards of Reporting Trials (CONSORT) score. ResultsThree of the four Observers rated all 10 studies as Level I, while one Observer rated 80% of the studies as Level I. Using the Coleman Methodology Score, the average score for all studies was 58.0 out of 100 points, designating the studies as “fair.” Areas of deficiency included clinical effect measurement and intent-to-treat analysis. Using the CONSORT checklist, the average score was 16.9 out of 22 points, designating the studies as “good”. Areas of deficiency included inadequate implementation of randomization and interpretation of results. DiscussionClinicians should critically evaluate research studies regardless of study design. A sophisticated study design and high level of evidence designation does not guarantee quality research. We determined that RCTs for PRP treatment of knee osteoarthritis were not as robust in quality despite their Level I Oxford Level of Evidence rating.

Completeness of reporting and outcome switching in trials published in Indian journals from 2017 to 2019: A cross-sectional study.

Context:Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences.Aims:The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred.Settings and Design:This cross-sectional study was conducted in the department of pharmacology.Methods:Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed.Statistical Analysis Used:Descriptive statistics were used to summarize the data.Results:Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison.Conclusions:Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.

Guidelines for reporting randomized controlled trials in paediatric dentistry based on the CONSORT statement.

The significance of randomized controlled trials (RCT) depends on how thoroughly the results were reported. Reporting of RCTs should be accurate and transparent and encompasses design, implementation, analysis, and results of the trial. The Consolidated Standards of Reporting Trials (CONSORT) statement and its extension were developed to guide the researchers to report clinical trials in a systematic manner. Despite this recommendation, the overall reporting quality of RCTs still remains suboptimal. To describe the relevance and importance of CONSORT reporting guidelines and explain the items using examples derived from randomized trials published in Paediatric Dentistry. This is a narrative review that illustrates the importance of reporting items in the CONSORT guidelines from relevant sources. RCTs published in the International Journal of Paediatric Dentistry between 2017 and 2020 were identified from PubMed and Scopus databases and through handsearching. An explanation has been provided for each of the 37 items in the 2010 CONSORT checklist and 17 items in the CONSORT extension for reporting abstracts. This explanation and elaboration document would enable investigators to report trials in Paediatric Dentistry with accuracy and transparency as well as for reviewers and editors in evaluating the suitability of RCTs for publication.

Development and Validation of a Natural Language Processing Tool to Generate the CONSORT Reporting Checklist for Randomized Clinical Trials

Adherence to the Consolidated Standards of Reporting Trials (CONSORT) for randomized clinical trials is associated with improvingquality because inadequate reporting in randomized clinical trials may complicate the interpretation and the application of findings to clinical care. To evaluate an automated reporting checklist generation tool that uses natural language processing (NLP), called CONSORT-NLP. This study used published journal articles as training, testing, and validation sets to develop, refine, and evaluate the CONSORT-NLP tool. Articles reporting randomized clinical trials were selected from 25 high-impact-factor journals under the following categories: (1) general and internal medicine, (2) oncology, and (3) cardiac and cardiovascular systems. For an evaluation of the performance of this tool, an accuracy metric defined as the number of correct assessments divided by all assessments was calculated. The CONSORT-NLP tool uses the widely used Portable Document Format as an input file. Of the 37 CONSORT reporting items, 34 (92%) were included in the tool. Of these 34 reporting items, 30 were fully implemented; 28 (93%) of the fully implemented CONSORT reporting items had an accuracy of more than 90% for the validation set. The remaining 2 (7%) had an accuracy between 80% and 90% for the validation set. Two to 5 articles were selected from each of these journals for a total of 158 articles to establish a training set of 111 articles to train CONSORT-NLP for CONSORT reporting items, a testing set of 25 articles to refine CONSORT-NLP, and a validation set of 22 articles to assess the performance of CONSORT-NLP. The CONSORT-NLP tool used the Portable Document Format of the articles as input files. A CONSORT-NLP graphical user interface was built using Java in 2019. The time required to complete the CONSORT checklist manually vs using the CONSORT-NLP tool was compared for 30 articles. Two case studies for randomized clinical trials are provided as an illustration for the CONSORT-NLP tool. For the 30 articles investigated, CONSORT-NLP required a mean (SD) 23.0 (4.1) seconds, whereas the manual reviewer required a mean (SD) 11.9 (2.2), 22.6 (4.6), and 57.6 (7.1) minutes, for 3 reviewers, respectively. The CONSORT-NLP tool is designed to assist in the reporting of randomized clinical trials. Potential users of CONSORT-NLP include clinicians, researchers, and scientists who plan to publish a randomized trial study in a peer-reviewed journal. The use of CONSORT-NLP may help them save substantial time when generating the CONSORT checklist. This tool may also be useful for manuscript reviewers and journal editors who review these articles.

A Historical Analysis of Randomized Controlled Trials in Rotator Cuff Tears.

Background and objectives: Our research aimed to evaluate the quality of reporting of randomized controlled trials (RCTs) linked to rotator cuff (RC) tears. The present study analyzed factors connected to the quality of the RCTs and trends in the quality of reporting through time. Materials and Methods: The online databases used to search all RCTs on the topic of RC surgery completed until March 2020 were PubMed and Ovid (MEDLINE). The quality of reporting was evaluated using the modified Coleman methodology score (MCMS) and the consolidated standards of reporting trials (CONSORT). Results: The online search found 957 articles. Finally, 183 studies were included in the quantitative synthesis. A total of 97 (53%) of 183 studies had a level of evidence I and 86 (47%) of 183 studies had a level of evidence II, according to the Oxford Center of Evidence Based Medicine (EBM). A statistically significant difference in MCMS between articles written before 2010 and articles written after 2010 was found. Articles written after 2010 had, on average, the highest Coleman score. The average number of CONSORT checklist items for each article across all analyzed RCTs was 21.67. The 37 studies completed up to 2010 averaged a number of checklist items of 19.97 and the studies completed between 2011 and 2019 averaged a number of checklist items of 22.10. A statistically significant difference in the number of checklist items between articles written before 2010 and articles written after 2010 was found. Articles written after 2010 had on average more checklist items. However, low correlation (0.26) between the number of checklist items for each article and the respective Coleman score was found. On the other hand, articles with the CONSORT diagram had a significantly high Coleman score. Conclusions: An improvement in the quantity and quality of RCTs relating to RC surgery over the analyzed period was found.

Assessment of the Quality of Randomized Clinical Trials Published by Iranian Researchers in Persian Internal Journals in 2014

Introduction: A randomized clinical trial is known as the best and most effective way to assess the effects of interventions if it is properly planned and implemented. The purpose of this study was to evaluate the quality of clinical trials published in Persian internal journals by Iranian researchers. Method: In this cross-sectional study, all the clinical trials published by Iranian researchers in the Iranian Journals in 2014, were evaluated according to entry criteria and finally 587 included articles were reviewed and their quality was evaluated by using Consolidated Standards of Reporting Trials (CONSORT) checklist. Results: The results revealed that the mean±SD adherence to the CONSORT checklist’s item in our included articles was 59.61±24.99. The lowest adherence to the items was seen for random allocation (76.1%), description of the sampling method (70.1%) and presenting RCT code registration (60.4%), respectively. The highest adherence was observed for title suitability (96%), appropriate presentation time and place of study (84.2%), a suitable expression of study participants (82.8%) and time duration of the study (82.3%). Conclusion: The adherence to the various items of CONSORT checklist in Iranian Persian language journals was not in satisfactory status. In this regard, the CONSORT checklist needs to be carefully followed for conducting and reporting RCTs by Iranian researchers.