Consolidated Standards Of Reporting Trials Statement Research Articles

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol

IntroductionThe aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension...

Adverse Events Reported in Trials Assessing Manual Therapy to the Extremities: A Systematic Review.

Objective: This review aimed to describe the quality and comprehensiveness of adverse event (AE) reporting in clinical trials incorporating manual therapy (MT) as an intervention for extremity conditions using the Consolidated Standards of Reporting Trials (CONSORT)-Harms extension as the benchmark. The secondary aim was to determine whether the quality of AE reporting improved after the availability of the CONSORT reporting checklist. Design: Systematic review. Methods: A literature search was conducted using multiple databases to identify trials where MT was used to treat extremity conditions. Studies that reported AEs were identified and evaluated using the CONSORT-Harms extension. The frequency of trials reporting study AEs before and after the publication of the updated 2010 CONSORT statement was calculated, along with the categorization of how study AEs were reported. Results: Of the 55,539 studies initially identified, 220 trials met all inclusion criteria. Eighty trials (36.4%) reported AE occurrence. None of the studies that reported AEs adhered to all 10 criteria proposed by the 2010 CONSORT-Harms extension. The most commonly reported criterion was number four, which clarified how AE-related information was collected (30% of trials). The least reported criterion was number six, which describes the participant withdrawals for each arm due to AEs and the experience with the allocated treatment (1.3% of trials). The nomenclature used to describe AEs varied substantially. Fifty-nine of 76 trials (33.3%) were published after the updated CONSORT Harms-checklist was available, compared to 21 of 44 trials (46.7%) published before it was available. Conclusion: Reporting of AEs in trials investigating MT for extremity conditions is poor. Every included trial lacked adherence to all 10 criteria proposed by the CONSORT-Harms Extension. The quality and comprehensiveness of AE reporting did not improve after the most recent CONSORT update recommending AE reporting. Clinicians must obtain informed consent before performing any intervention, including MT, which requires disclosing potential risks, which could be better known with improved tracking, analyzing, and reporting of AEs. The authors recommend improved adherence to best practices for adequately tracking and reporting AEs in future MT trials.

The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas.

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors.

Reporting quality of randomized controlled trials of percutaneous patent foramen ovale closure for the treatment of migraine based on the CONSORT statement

Abstract Background Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine. Purpose The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist. Methods Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement. Results The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF>30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score. Conclusions Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.

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.

Intracluster correlation coefficients in osteoarthritis cluster randomized trials: A systematic review

The design, analysis, and interpretation of cluster randomized clinical trials (RCTs) require accounting for potential correlation of observations on individuals within the same cluster. Reporting of observed intracluster correlation coefficients (ICCs) in cluster RCTs, as recommended by Consolidated Standards of Reporting Trials (CONSORT), facilitates sample size calculation of future cluster RCTs and understanding of the trial statistical power. Our objective was to summarize observed ICCs in osteoarthritis (OA) cluster RCTs. Systematic review of knee/hip OA cluster RCTs. We searched Cochrane Central Register of Controlled Trials for trials published from 2012, when CONSORT cluster RCTs extension was published, to September 2022. We calculated the proportion of cluster RCTs that reported observed ICCs. Of those that did, we extracted observed ICCs. CRD42022365660. We screened 1121 references and included 20 cluster RCTs. Only 5 trials (25%) reported the observed ICC for at least one outcome variable. ICC values for pain outcomes were: 0, 0.01, 0.18; for physical function outcomes were: 0, 0.06, 0.13 (knee)/0.27 (hip); Western Ontario and McMaster Universities Arthritis Index (WOMAC) total: 0.02, 0.02; symptoms of anxiety/depression: 0.22; disability: 0; and global change: 0. One out of four (25%) trials reported an ICC that was larger than the ICC used for sample size calculation and thus was underpowered. Despite CONSORT statement recommendations for reporting cluster RCTs, few OA trials reported the observed ICC. Given the importance of the ICC to interpretation of trial results and future trial design, this reporting gap warrants attention.

Methodological quality of randomized controlled trials of home-based rehabilitation in knee osteoarthritis: A cross-sectional survey

Background/Aim: This study aimed to evaluate the methodological quality of randomized controlled trials (RCTs) that examine home-based rehabilitation (HBR) trials for knee osteoarthritis (KOA) using the Physiotherapy Evidence Database (PEDro) scale and the nine methodology-related items of the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.
 Methods: Three electronic databases were scanned from baseline to October 10, 2021. Two reviewers independently evaluated the articles according to the two inclusion criteria: (1) in individuals diagnosed with KOA, at least one group received home-based rehabilitation as a study intervention and (2) at least one group received a comparison intervention or no intervention. The methodological quality of the included studies (n=22) was assessed using the PEDro scale and nine items of the CONSORT 2010 statement.
 Results: Among 1557 RCTs, 22 studies that fulfilled our criteria were included in the review. The mean PEDro scale score was 5.77 (1.54). This result reflects moderate methodological quality. Concealed allocation (6; 27.3%), blinding of subjects (4; 18.2%), and (0; 0.0%) of therapists associated with the methodological quality were not reported in most studies. An author’s expertise in epidemiology and/or statistics was 0.78 points (95% confidence interval [CI] 0.11–1.44), the multicenter study 0.94 points (95% CI: 0.19–1.68), and a one-unit increase in the total score of the CONSORT statement led to an increase in methodological quality of 0.55 points (95% CI: 0.34–0.76).
 Conclusion: The methodological quality of most RCTs examining HBR in KOA that we included in our systematic review was moderate. The adherence of journals and authors to CONSORT checklists in reporting of studies may lead to an improvement in the methodological quality of future published studies.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

Effects of Roux-en-Y gastric bypass on the metabolic profile and systemic inflammatory status of women with metabolic syndrome: randomized controlled clinical trial

BackgroundObesity remains a public health problem worldwide. The high prevalence of this condition in the population raises further concerns, considering that comorbidities are often associated with obesity. Among the comorbidities closely associated with obesity, metabolic syndrome (MS) is particularly important, which potentially increases the risk of manifestation of other disorders, such as the prothrombotic and systemic pro-inflammatory states.MethodsA randomized, controlled clinical trial was performed involving female patients (n = 32) aged between 18 and 65 years, with a clinical diagnosis of MS, with severe obesity undergoing Roux-en-Y gastric bypass (RYGB). The study design followed the Consolidated Standards of Reporting Trials statement (CONSORT). Lipid profile, blood glucose and adipokines (adiponectin, leptin, and resistin) and (cytokines IL-1β, IL-6, IL-17, IL-23, and TNF-α) in blood plasma samples were evaluated before and six months after RYGB.ResultsPatients undergoing RYGB (BSG) showed a significant improvement from preoperative grade III obesity to postoperative grade I obesity. The results showed that while HDL levels increased, the other parameters showed a significant reduction in their postoperative values when compared not only to the values observed before surgery in the BSG group, but also to the values obtained in the control group (CG). As for systemic inflammatory markers adiponectin, leptin, resistin, IL-1β, IL-6, IL-17, IL-23 and TNF- α it was observed that the levels of resistin and IL-17 in the second evaluation increased significantly when compared to the levels observed in the first evaluation in the CG. In the BSG group, while the levels of adiponectin increased, the levels of the other markers showed significant reductions in the postoperative period, in relation to the respective preoperative levels. The analysis of Spearman’s correlation coefficient showed a significant positive correlation between IL-17 and IL-23 in the preoperative period, significant positive correlations between TNF-α and IL-6, TNF-α and IL-17, IL-6 and IL-17, and IL-17 and IL-23 were observed postoperatively.ConclusionsAccording to our results, the reduction of anthropometric measurements induced by RYGB, significantly improves not only the plasma biochemical parameters (lipid profile and glycemia), but also the systemic inflammatory status of severely obese patients with MS.Trials registration NCT02409160

Acute Adductor Muscle Injury: A Systematic Review on Diagnostic Imaging, Treatment, and Prevention

Background: Controversies remain regarding the diagnosis, imaging, and treatment of acute adductor injuries in athletes. Purpose: To investigate the diagnostic imaging, treatment, and prevention of acute adductor injuries based on the most recent and relevant scientific evidence. Study Design: Systematic review; Level of evidence, 4. Methods: The PubMed and Web of Science databases were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify articles studying acute adductor injury in athletes. Inclusion criteria were original publication on acute adductor injury in amateur or professional athletes, level 1 to 4 evidence, mean patient age >15 years, and results presented as return-to-sport, pain, or functional outcomes. Quality assessment was performed with the CONSORT (Consolidated Standards of Reporting Trials) statement or the methodological index for non-randomized studies criteria. Articles were grouped as imaging, treatment, prevention focused, or mixed. Results: A total of 30 studies published between 2001 and 2021 were selected, involving 594 male patients with a mean age 26.2 years (range, 16-68 years). The most frequent sports were soccer (62%), basketball (14%), futsal (6%), American football (3%), and ice hockey and handball (2%). Risk factors for acute adductor injury were previous acute groin injury, adductor weakness compared with the uninjured side, any injury in the previous season, and reduced rotational hip range of motion. The frequency of complete adductor muscle tears on magnetic resonance imaging was 21% to 25%. For complete adductor tears, the average time to return to play was 8.9 weeks in patients treated nonoperatively and 14.2 weeks for patients treated surgically. Greater stump retraction was observed in individuals treated surgically. Partial acute adductor tears were treated nonoperatively with physical therapy in all studies in the present systematic review. The average time to return to play was 1 to 6.9 weeks depending on the injury grade. The efficacy of adductor strengthening on preventing acute adductor tears has controversial results in the literature. Conclusion: Athletes with partial adductor injuries returned to play 1 to 7 weeks after injury with physical therapy treatment. Nonoperative or surgical treatment is an acceptable option for complete adductor longus tendon tear.

A comparison of a precordial belt ECG and a gel-adhesive electrode in terms of ECG acquisition time and usability in emergency department patients

An electrocardiogram (ECG) is a fast, valuable, and non-invasive test that has a wide range of uses in the diagnosis, examination, screening, and prognosis of many cardiac and non-cardiac morbidities. The study was designed as a prospective, single-blind randomized controlled, single center. The CONSORT (Consolidated Standards of Reporting Trials) statement is used. The patients were divided into two groups: Group Gel Adhesive Electrode (GAE) and Group precordial belt ECG (PBE), according to the ECG recording technique. The results between the two groups were compared. A total of 250 patients were included in the study. 127 patients were included in the Group GAE and 123 patients were included in the Group PBE. The mean ECG recording time of patients in the Group GAE was 86.83 ± 22.53 seconds, while it was 59.56 ± 15.08 seconds in the Group PBE. When the ECG recording time is evaluated, the mean of the patients in the Group PBE is shorter, and there is a statistically significant difference between the two groups (p < 0.001). When evaluated in terms of the need for repeat ECG acquisitions of the ECG (Group PBE: 9.75%, Group GAE: 14.96%), there is no statistically significant difference between the groups (p = 0.251). Causes of a repeat ECG were chest hair (Group GAE: 3.15%, Group PBE: 6.50%; p = 0.215), perspiration (Group GAE: 8.66%, Group PBE: 3.15%; p = 0.108), shaking (Group GAE: 15%, Group PBE: 0%; p = 0.122). Compared to the GAE, the precordial ECG Belt may be more advantageous in terms of examination time.

Assessment of the reporting quality of randomised controlled trials for vitamin D supplementation in autoimmune thyroid disorders based on the CONSORT statement.

Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine, yet their quality is often suboptimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is a list of advice to upgrade the quality of RCTs. The aim of this study was the assessment of the quality of RCTs for vitamin D supplements in thyroid autoimmunity according to the revised CONSORT 2010 checklist. Databases were searched for RCTs involving patients with autoimmune thyroid disorders (AITDs) who received vitamin D supplements published from 2011 to 2021. A list of 37-items was used and adherence ≥75% was considered of optimal quality. The primary outcome was the mean CONSORT adherence of studies. Secondary outcomes were the estimation of compliance per CONSORT item and the examination for possible determinants of the reporting quality. Thirteen eligible trials were finally included. The mean compliance was 61.15% ± 14.86%. Only threeof the studies (23%) achieved a good reporting quality (≥75%), while ten (77%) were presented with inadequate reporting (<75%). Randomization and blinding were mainly poorly reported. Impact Factor (IF) of journal was associated with the reporting quality in the univariate analysis [p = 0.033, OR = 1.65, 95%CI = (1316, 1773)]. Sample size (p = 0.067), number of authors (p = 0.118) and number of citations (p = 0.125) were marginally not significant. None of the factors showed significant results in multivariate analysis. Reporting quality and IF were strongly positively correlated [Pearson's r = 0.740, p = 0.04]. This study shows that mean CONSORT adherence of RCTs for Vitamin D supplementation in AITDs is moderate, reflecting that study quality and transparency could be improved with better adherence to CONSORT rules.

Establishing an institutional EAP teacher development scheme based on BALEAP's competency framework: A critical review of the competencies

In clinical research, randomised controlled trials (RCTs) are considered to be “the gold standard” for evaluating treatments. Accordingly, RCT reporting in top English-medium medical journals is specifically regulated by The Consolidated Standards of Reporting Trials (CONSORT) Statement. However, although the CONSORT Statement prescribes the content items that are to be included in a report, little guidance is offered on how the content can be communicated effectively. This paper explores a linguistic construction of a research gap in the introductory sections of medical research articles that report on RCTs (i.e., RCT reports), which has been identified as crucial in the process of RCT justification. In this study, a sample of Introduction sections extracted form recently published RCT reports was analysed using a systemic functional linguistic (SFL) approach to genre and evaluation. The findings indicate that RCT report writers tend to create a research gap by embedding the rhetorical structures of three arguing genres – expositions, discussions, and challenges – into their research warrants. The results of this study carry pedagogical implications for RCT report writing training.

Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation

IntroductionIncisional hernia (IH) is the most frequent mid-term and long-term complication after midline laparotomy. The current standard treatment includes repair using a mesh. In a contaminated field, the use of...

A linguistic construction of a research gap in reports of randomised controlled trials: A systemic functional perspective

In clinical research, randomised controlled trials (RCTs) are considered to be “the gold standard” for evaluating treatments. Accordingly, RCT reporting in top English-medium medical journals is specifically regulated by The Consolidated Standards of Reporting Trials (CONSORT) Statement. However, although the CONSORT Statement prescribes the content items that are to be included in a report, little guidance is offered on how the content can be communicated effectively. This paper explores a linguistic construction of a research gap in the introductory sections of medical research articles that report on RCTs (i.e., RCT reports), which has been identified as crucial in the process of RCT justification. In this study, a sample of Introduction sections extracted form recently published RCT reports was analysed using a systemic functional linguistic (SFL) approach to genre and evaluation. The findings indicate that RCT report writers tend to create a research gap by embedding the rhetorical structures of three arguing genres – expositions, discussions, and challenges – into their research warrants. The results of this study carry pedagogical implications for RCT report writing training.

Assessment of Reporting Quality in Randomized Controlled Trials of Acupuncture for Primary Insomnia with CONSORT Statement and STRICTA Guidelines

Aim To assess the reporting quality of randomized controlled trials (RCTs) on acupuncture for primary insomnia (PI). Methods Seven Chinese and English databases were searched for publication reporting RCTs on acupuncture for PI from the inception of the databases to August 6, 2021. The internationally recognized Consolidated Standards of Reporting Trials (CONSORT) statement and the International Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines were used to evaluate the reporting quality. The agreement between two researchers was calculated by Cohen's kappa. Results A total of 102 eligible RCTs were assessed. According to the CONSORT statement (2017), the positive reporting rates of items such as “abstract,” “background,” “participants,” and “numbers analyzed” were above 80%. However, the positive reporting rates of items such as “sample size,” “randomization implementation,” “Outcomes and estimation,” “Ancillary analyses,” and “Registration” were below 20%. According to STRICTA guidelines, the positive reporting rates of items such as “style of acupuncture,” “reasons for acupuncture treatment,” “Number of needles inserted,” “Needle retention time,” “Treatment regimen,” and “precise description of the control intervention” were above 80%. However, the positive reporting rates of items such as “setting and context of treatment” and “practitioner background” were below 20%. Conclusion It is essential to advocate the endorsement of the CONSORT statement and STRICTA guidelines to improve the quality of acupuncture RCT reports.

Analysis report of adherence to consort statement for reporting randomized controlled trials (RCTs) Associated with temporomandibular disorders (TMDs): A cross-sectional study

Purpose: Temporomandibular disorders (TMDs) and their management are widely sought after by clinicians. They often refer to the reported randomized controlled trials (RCTs) in the literature. The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve the quality of published RCTs and is endorsed by healthcare journals. Despite the widespread acceptance of CONSORT, its use for reporting clinical trials in the journals remains suboptimal. The purpose of this study was to evaluate, to what extent RCTs related to TMDs have adhered to the CONSORT statement. Methodology: RCTs related to TMDs, published in PubMed from January 2017 to March 2021 were retrieved. Each article was assessed for its adherence to the CONSORT statement by four trained and calibrated investigators. Results: 88 articles were evaluated. Out of 37 items in the checklist, only 4 items demonstrated 100% adherence (item 2a, 2b, 5, 12a, and 16). The most under-reported items were 7a, 8b, 9, 10, 17a, 17b, 19, 23, and 24 (less than 50%). The mean percentage of adherence remained 71.2 ± 12.6. Only one study showed 100% adherence and three studies had less than 50% adherence. Considering adherence of abstract checklist, three items demonstrated 100% adherence (items 4, 5, and 6). Poor reporting was noted with items 8, 13, 15, and 16. The mean percentage of adherence to abstract reporting remained 68.60 ± 11.79. Conclusion: The present study indicates good adherence to CONSORT statement in reporting RCTs related to TMD management. Probably the mandatory instructions from the journals and increasing awareness among the researchers about CONSORT reporting might have done the trick.

Application of the Consolidated Standards of Reporting Trials (CONSORT) Statement Guideline in Nursing Studies: Analytical Review

Background: Randomized Controlled Trials (RCTs), also called randomized clinical trials, are regarded as the most reputable source of evidence that provides the best guide of the effectiveness of nursing interventions during the Evidence-Based Practice (EBP) period and, however, yet in the nursing literature, has not been evaluated the quality of reporting RCT. Practical and conceptual challenges to the EBP nursing movement have been. The limited available scientific evidence on the efficacy of many nursing practices is one of the serious concerns. EBP requests that study evidence from RCTs and other forms of intervention studies that are still limited in nursing be synthesized. On the other hand, comprehensive evaluations, meta-analyses, and systematic reviews that are performed in nursing are also that limited when compared to other disciplines, such as psychology and medicine. Aims of the study: The study aimed at applying the declaration of the Consolidated Standards of Reporting Trials (CONSORT) statement to nursing and healthcare provider studies and adequacy of the published reports adhere to the statement and how the content of the published RCTs is being influenced by the adoption of CONSORT on the quality of reporting RCT. Methodology: Analytical review of literature based on previous studies and reviews derived of international publishers such as (Scopus, PubMed, and Medline) databases concerning Consolidated Standards of Reporting Trials (CONSORT) Statement Guideline. The collection of data was conducted from 24 November 2020 to 10 February 2021. These studies were collected and filtered according to the specific criteria. Also, was used keywords such as CONSORT, nursing studies, evidence-based practice, evidence-based nursing practice, randomized controlled trial, as well as the articles by the National Library of Medicine, which provided valid and documented data of global research and epidemiology. Conclusion: Evidence-based practice (EBP) is rooted in solid evidence that the assumption (science-based nursing) in patient care should be supported by sound evidence. It is important that nursing professionals use the CONSORT statement to review, publish, and utilize their reports of nursing clinical and gather the best evidence to support their clinical practice of use and their decision-making. Recommendations: The authors should consult supervisors and biostatisticians experts early when formulating the study and analysis protocol to improve the quality of reporting the trials in nursing studies. Determine primary and secondary outcomes in advance, preferably in a published protocol. Use adequate checklists reporting, e.g., Consolidated Standards of Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).

Compliance of randomized controlled trials in posterior restorations with the CONSORT statement: a systematic review of methodology.

This study aims to investigate the compliance of randomized controlled trials (RCTs) in posterior restorations with the Consolidated Standards of Reporting Trials Statement (CONSORT) statement and to analyze the risk of bias (RoB) of these studies. A systematic search was performed in PubMed, Scopus, Web of Science, LILACS/BBO, and Cochrane Library. Only RCTs published in peer-reviewed journals were included. The compliance with the CONSORT was evaluated in a 0-2 scale where 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the CONSORT mean score by journal, country, and RoB were performed. The RoB in RCTs was evaluated by using the Cochrane Collaboration's tool version 1.0. A total of 15,476 studies were identified after duplicates removal. O only 202 meet the eligibility criteria, among which 31 were follow-up studies. Concerning the overall RoB, only 29 out of 171 were classified as low risk of bias. The overall mean CONSORT score was 19 ± 5.4 points, which means compliance of approximately 59%. Significant differences among countries, publication period, and RoB were observed (p < 0.001). The journal's impact factor was not correlated with the overall CONSORT score (p = 0.36). The adherence of RCTs conducted in posterior restorations to the CONSORT Statement is still low. In addition, most studies were classified as at unclear risk of bias. These results call up an urgent need for improvement. Most RCTs conducted in posterior teeth have poor reporting and are mainly classified as having an unclear risk of bias.

Surgical Outcomes of Inguinal-, Pubic-, and Adductor-Related Chronic Pain in Athletes: A Systematic Review Based on Surgical Technique.

Background:Controversies remain regarding the surgical treatment of inguinal-, pubic-, and adductor-related chronic groin pain (CGP) in athletes.Purpose:To investigate the outcomes of surgery for CGP in athletes based on surgical technique and anatomic area addressed.Study Design:Systematic review; Level of evidence, 4.Methods:The PubMed and Embase databases were searched for articles reporting surgical treatment of inguinal-, pubic-, or adductor-related CGP in athletes. Inclusion criteria were level 1 to 4 evidence, mean patient age >15 years, and results presented as return-to-sport, pain, or functional outcomes. Quality assessment was performed with the CONSORT (Consolidated Standards of Reporting Trials) statement or MINORS (Methodological Index for Non-randomized Studies) criteria. Techniques were grouped as inguinal, adductor origin, pubic symphysis, combined inguinal and adductor, combined pubic symphysis and adductor, or mixed.Results:Overall, 47 studies published between 1991 and 2020 were included. There were 2737 patients (94% male) with a mean age at surgery of 27.8 years (range, 12-65 years). The mean duration of symptoms was 13.1 months (range, 0.3-144 months). The most frequent sport involved was soccer (71%), followed by rugby (7%), Australian football (5%), and ice hockey (4%). Of the 47 articles reviewed, 44 were classified as level 4 evidence, 1 study was classified as level 3, and 2 randomized controlled trials were classified as level 1b. The quality of the observational studies improved modestly with time, with a mean MINORS score of 6 for articles published between 1991 and 2000, 6.53 for articles published from 2001 to 2010, and 6.9 for articles published from 2011 to 2020. Return to play at preinjury or higher level was observed in 92% (95% CI, 88%-95%) of the athletes after surgery to the inguinal area, 75% (95% CI, 57%-89%) after surgery to the adductor origin, 84% (95% CI, 47%-100%) after surgery to the pubic symphysis, and 89% (95% CI, 70%-99%) after combined surgery in the inguinal and adductor origin.Conclusion:Return to play at preinjury or higher level was more likely after surgery for inguinal-related CGP (92%) versus adductor-related CGP (75%). However, the majority of studies reviewed were methodologically of low quality owing to the lack of comparison groups.