Consolidated Standards Of Reporting Trials Statement Research Articles

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.

Effects of Occupational Therapy Interventions on Improving Play Performance in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): A Systematic Review

Objectives: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common disorder among neurodevelopmental disorders. Children with ADHD have serious difficulties in their playing patterns. This review aims at seeing occupational therapy interventions using to improve play among children with ADHD. Methods: Four databases (PubMed, Web of Science, Scopus, and Elsevier) were searched. Rayyan QCRI online application was used for managing and screening the obtained data. The included articles were reviewed for their quality based on the Centre of Evidence-Based Medicine, research pyramid, CONSORT (CONsolidated Standards Of Reporting Trials), and STARD (Standards for Reporting Diagnostic Accuracy) statement. Results: A total of 104 articles were found after the search. After the screening and review process, six articles were included for the main review. Data extraction was done for these six articles (two randomized trial control and four non-randomized trial control studies). Discussion: Play-based interventions could be effective for improving social play in ADHD when delivered by a therapist. For parent-delivered interventions, more studies with larger sample sizes are required.

The Inconsistent and Inadequate Reporting Of Immune-Related Adverse Events in PD-1/PD-L1 Inhibitors: A Systematic Review of Randomized Controlled Clinical Trials.

BackgroundImmune‐related adverse events (irAEs) are of great interest and importance in clinical practice, and many deficiencies and controversies have been noted in the reporting of irAEs. Herein, we aimed to evaluate the current status of irAE reporting in randomized controlled clinical trials (RCTs) of PD‐1/PD‐L1 inhibitors and to attempt to explain and solve the current pitfalls associated with this reporting.Materials and MethodsWe conducted a systematic review across multiple databases, including PubMed, Web of Science, Embase, and the Cochrane Library. The RCTs that compared PD‐1/PD‐L1 inhibitors with standard treatments were included. The Harms extension of the Consolidated Standards of Reporting Trials (CONSORT) was used to evaluate the completeness of irAE reporting.ResultsA total of 44 articles and 23,759 patients were included in the analysis. The terminology of the irAEs changed over time (p = .01) and was different among immune checkpoint inhibitors (ICIs) (p = .005). Twenty‐two of the studies provided a definition of irAE, but only four of them concretely addressed this definition. The incidence of any grade of irAEs ranged from 16.9% to 96%, whereas grade 3–4 irAE ranged from 2% to 23%. The RCTs with combined therapy exhibited a higher incidence of grade 3–4 irAEs (p = .012). Thirty‐two studies reported irAEs in the control arms, whereas seven studies reported irAEs only in the experimental arms. Respiratory, endocrine, and gastrointestinal disorders were the most commonly reported irAEs. IrAEs were generally neglected in the introduction or conclusion sections in all of the study reviews and were never subjected to subgroup analyses. Moreover, withdrawals due to severe irAEs, as well as clarifications of the irAE collection methods, were also poorly reported. RCTs using combination therapies in the experimental arms were associated with a higher reporting quality (p = .032). However, the completeness of the reporting did not improve over the last 5 years (p = .076).ConclusionThe reporting of irAEs was inadequate, and there are still inconsistencies and controversies in the reporting of irAEs. In the future, authors should be encouraged to adhere to the Harms extension of the CONSORT statement.Implications for PracticePD‐1/PD‐L1 inhibitors profoundly changed the landscape of cancer treatment, and thousands of randomized controlled clinical trials (RCTs) were active or completed over the past decade. However, different from chemotherapy or targeted therapy, the profile of immune‐related adverse effects (irAE) was unique. An understanding of irAEs is developed mainly from clinical trials; however, inconsistencies and controversies between trials were noted. This study primarily reviewed the evolution of irAE terminology and definitions and evaluated the reporting quality of each RCT. It was found that RCTs using combined immunotherapy were associated with higher quality of irAE reporting. This article identifies the controversies and deficiencies in current irAE reporting and provides possible explanations and suggestions for these inadequacies.

Quality Evaluation of Randomized Controlled Trials of Rhodiola Species: A Systematic Review.

Background Rhodiola is a worldwide used medicinal plant for its various medicinal functions, and the number of randomized controlled trials (RCTs) of Rhodiola is increasing in recent years. This study aims to evaluate the reporting quality and risk of bias of the current RCT reports of different Rhodiola species. Methods Six databases including Embase, PubMed, Web of Science, the Cochrane Library, ClinicalTrial.gov, and China National Knowledge Infrastructure were searched to identify RCTs that used Rhodiola as a single intervention and were published in English or Chinese from inception to December 2020. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement was used as the checklist for assessment, and a scoring system was applied to the evaluation of RCTs. Score 0 represents no reporting or inadequate reporting, and score 1 represents adequate reporting. The risk of bias of the included studies was also assessed using the Cochrane Risk of Bias tool. Results A total of 39 RCTs were included in this study, including 23 RCTs of Rhodiola rosea (R. rosea), 8 RCTs of Rhodiola crenulata (R. crenulata), and 8 RCTs of Rhodiola wallichiana (R. wallichiana). None of the included studies met all the CONSORT statement criteria, and the reporting quality of RCTs of the three Rhodiola species was all generally poor. Based on the risk of bias assessment, the majority of included studies were judged to have an unclear risk of bias in most domains due to inadequate reporting. Conclusions There is inadequate reporting among the included RCTs of different Rhodiola species, and RCTs of Rhodiola with higher reporting quality and better methodological quality are needed.

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review.

The Consolidated Standards of Reporting Trials (CONSORT) recommends reporting adverse events (AEs) and dropouts (DOs) with their definitions. The purpose of this study was to identify how AEs and DOs were reported in randomized controlled trials of therapeutic exercise for knee osteoarthritis (OA). Data sources were the Cochrane Library, Embase, PubMed, and CINAHL. Databases were searched to identify randomized controlled trials of therapeutic exercise for knee OA published from January 1, 1980, through July 23, 2020. Researchers independently extracted participant and intervention characteristics and determined whether a clear statement of and reasons for AEs and DOs existed. The primary outcome was exercise-related harm. Physiotherapy Evidence Database (PEDro) scoring described study quality and risk of bias. Descriptive and inferential statistics characterized results. Meta-analysis was not performed due to data heterogeneity. One hundred and thirteen studies (152 arms) from 25 countries were included, with 5909 participants exercising. PEDro scores ranged from 4 to 9. Exercise intensity was not specified in 57.9% of exercise arms. Fifty studies (44.2%) included an AE statement and 24 (21.2%) reported AEs, yielding 297 patients. One hundred and three studies (91.2%) had a DO statement. Sixteen studies (15.5%) provided reasons for DOs that could be classified as AEs among 39 patients, yielding a 13.1% increase in AEs. Thus, 336 patients (6.0%) experienced exercise-related harm among studies with a clear statement of AEs and DOs. A significant difference existed in misclassification of DOs pre- and post-CONSORT-2010 (12.2% vs 3.1%; $\chi^{2}_{1} = 21.2$). In some studies, the reason for DOs could be considered AEs, leading to potential underreporting of harm. Improvements in reporting of harm were found pre- and post-CONSORT-2010. Greater clarity regarding AE and DO definitions and therapeutic exercise intensity are needed to determine safe dosing and mode of therapeutic exercise for knee OA. More adherence to the CONSORT statement is needed regarding reporting of and defining of AEs, DOs, and therapeutic exercise intensity; however, despite this, therapeutic exercise seems to be associated with minimal risk of harm.

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.

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.

Requirements for Study Registration and Adherence to Reporting Guidelines in Surgery Journals: A Cross‐Sectional Study

Reporting guidelines and study registration can minimize bias and improve the reporting quality of biomedical research, but may not be fully utilized. The objective of this study was to investigate the policies of surgery journals as for reporting guidelines and study registration and explore associated journal characteristic variables. Study samples were obtained from the Expanded Science Citation Index of the 2018 Journal Citation Reports (surgery category). The online guides for authors were browsed to identify which journals endorsed reporting guidelines and study registration. The predictors related to the endorsement were explored by using Chi-square test and multivariate logistic regression analysis, respectively. One hundred and eighty-eight surgery journals were included in our study. One hundred and sixty-three journals (86.7%) endorsed reporting guidelines and 103 journals (54.8%) endorsed study registration. About reporting guidelines, ICMJE (International Committee of Medical Journal Editors) recommendations were the most frequently endorsed (n = 155, 82.4%) by journals, followed by CONSORT (Consolidated Standards of Reporting Trials) statement (n = 94, 50.0%). About study registration, randomized controlled trial registration was endorsed by 101 (53.7%) journals, whereas the systematic review registration was endorsed by only 9 journals (4.8%). The results of multivariate logistic regression analysis revealed that not North America, higher JCR (Journal Citation Reports) rank journals were more likely to endorse reporting guidelines and study registration. Surgery journals frequently use reporting guidelines, but nearly half of journals did not require study registration. Implementing these two mechanisms can prevent bias, and their adoption should be strengthened by authors, reviewers and journal editors in surgery.

A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials.

The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of reporting of TB vaccine trials according to the latest version of the CONSORT statement, released in 2010. We searched PubMed and the Cochrane Central Register of Controlled Trials in August 2019. We conducted screening, study selection, and data extraction in duplicate; and resolved differences through discussion. We assessed reporting to be adequate if trials reported at least 75% of the CONSORT 2010 items. We conducted a trend analysis to assess if there was improvement in reporting over time. We also used logistic regression to assess factors associated with adequate reporting. We included 124 trials in the analyses. The mean proportion of adherence was 67.3% (95% confidence interval 64.4% to 70.1%), with only 46 (37%) trials having adequate reporting. There was a significant improvement in the quality of reporting over time (p < 0.0001). Trials published in journals with impact factors between 10 and 20 were more likely to have adequate reporting (odds ratio 9.4; 95% confidence interval 1.30 to 67.8), compared to lower-impact-factor journals. Despite advances over time, the reporting of TB vaccine trials is still inadequate and requires improvement.

Reporting of Randomized Controlled Trials Investigating an Enteral or Parenteral Nutrition Intervention in Critical Illness According to the CONSORT Statement: A Systematic Review and Recommendation of Minimum Standard Reporting Criteria

Lack of reporting consistency is common in randomized controlled trials (RCTs) in critical care nutrition. This impacts synthesis and interpretation and may misinform clinical practice. The objective was to evaluate reporting of parallel-group RCTs of enteral or parenteral nutrition interventions in critically ill adults against the recommendations in the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines and a priori-defined nutrition criteria. A systematic search of CENTRAL, MEDLINE, EMBASE, and CINAHL was conducted to identify RCTs published from January 2011 to February 14, 2020. The primary outcome was the percentage of CONSORT criteria "completely met" (a score of 1) from all included studies (out of a total possible score of 37). Secondary outcomes included the percentage of CONSORT criteria that were "partially" or "not met" and the percentage of a priori-defined nutrition criteria that were "completely," "partially," or "not met" (adjusted to reflect criteria applicable to the paper). Data are presented as mean (standard deviation). Comparisons of normally distributed continuous data were made using a t-test (P < .05). Of 18,969 articles identified, 56 studies met inclusion criteria. Of these, 60% (19%) of the eligible CONSORT criteria were "completely met," 20% (9%) "partially met," and 20% (15%) "not met." For the nutrition criteria, 41% (20%) of the eligible criteria were "completely met," 25% (14%) "partially met," and 34% (17%) "not met." Reporting against CONSORT guidelines was variable and often incomplete in relation to important a priori-defined nutrition variables.

Quality of patient-reported outcome reporting according to the CONSORT statement in randomized controlled trials with glioblastoma patients.

Randomized controlled trials (RCTs) represent the best evidence in oncology research. Glioblastoma is the most frequent and deadly primary brain tumor, affecting health-related quality of life. An important end point is patient-reported outcomes (PROs). There are no data regarding how well publications of glioblastoma RCTs report PROs. A specific PRO extension of the Consolidated Standards of Reporting Trials (CONSORT) statement was created to improve the quality of reporting. The aim of this study was to evaluate adherence to the CONSORT-PRO statement in reporting RCTs addressing the treatment of patients with glioblastoma. PRO analysis methodology was explored and criteria associated with higher quality of reporting were investigated. From PubMed/MEDLINE and the Cochrane Library databases, all phase 2 and 3 RCTs related to glioblastoma published between 1995 and 2018 were reviewed according to the CONSORT-PRO statements. An overall quality score on a 0 to 100 scale was defined based on these criteria and factors associated with this score were identified. Forty-four RCTs were identified as relevant according to predefined criteria. The median overall quality score was 26. No difference was observed regarding reporting quality over the years. CONSORT-PRO items concerning data collection and analysis were poorly reported. Thirty-four trials (77%) used longitudinal data. The most frequent statistical method for PROs analysis was the mean change from baseline (63%). Factors associated with improved overall quality score were the presence of a secondary publication dedicated to PROs results, the statement of any targeted dimensions, and when trials reported results using multiple methods. Despite the importance of measuring PROs in patients with glioblastoma, employment of the CONSORT-PRO statement is poor in RCTs.

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.

Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis as governed by the CONSORT statement.

Randomized controlled trials (RCTs) are the gold standard research in evaluating healthcare interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement improves the quality of RCTs in an evidence-based approach. To evaluate the reporting quality of published RCTs concerning the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis according to the CONSORT statement.Electronic databases were searched for English-language RCTs involving patients who received either anticoagulant or antiplatelet medication for prophylaxis of deep vein thrombosis and pulmonary embolism published from 2000 to 2019. Trials were considered eligible when the included patients received either anticoagulant or antiplatelet medication for primary and secondary prevention of deep vein thrombosis or pulmonary embolism and were randomly assigned to at least two treatment arms. Quality of reporting was assessed using a 37-item questionnaire based on the CONSORT 2010 checklist. Reporting was assessed in 2 publication periods (2000-2009) and (2010-2019). The effect of CONSORT statement in high- and low-ranked medical journals, according to their impact factor, has also been evaluated. The search identified 13 eligible articles for analysis. Only 12 of the 37 items of the checklist were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Improvements over time were seen for items that assessed the methodological quality with no statistically significant difference. RCTs published in high-ranked journals showed better quality of reporting.Quality of reporting in RCTs focusing on the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.

The effect of the CONSORT statement on the amount of "unclear" Risk of Bias reporting in Cochrane Systematic Reviews.

The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear". In this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews. All Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (≤1995, 1996-2000, 2001-2009 and ≥2010) based on the release- and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression. Data was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published ≥2010, compared to ≤1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)). A slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.

The effect of home-based exercise in sleep quality and excessive daytime sleepiness in elderly people: A protocol of randomized controlled clinical trial

Background: Sleep-disordered breathing is associated with significant morbidity and mortality, presenting a high prevalence in the general population and being considered today as an important public health problem worldwide, affecting about 45% of the world population. It is estimated that about from 50 to 75% of the elderly complain of difficulties in initiating or maintaining sleep. The regular practice of physical exercise of mild to moderate intensity is associated with improved sleep quality in the elderly and has increased its recommendation as one of the main non-pharmacological resources of preventive and therapeutic action. Objectives: To verify the effect of a semi-supervised home-based physical exercise program on sleep quality in a sedentary elderly population, which influences the improvement of self-reported sleep quality and the reduction of excessive daytime sleepiness in a sedentary elderly population. Methods: This protocol study of randomized, controlled, blinded clinical trial was designed, is being conducted and will be reported according to the guidelines of the CONSORT (Consolidated Standards of Reporting Trials) Statement, and is being conducted from July 2016 to December 2017, involving elderly people of both sexes, over 60 years old, living in Senhor do Bonfim. The home physical exercise program is based on the recommendations of the American College of Sports Medicine for exercise and physical activity for the elderly. Results: The first expected outcome is the improvement of self-reported sleep quality verified through the PSQI. The secondary outcomes are reduction in excessive daytime sleepiness among the sedentary elderly subjects undergoing the semi-supervised home-based physical exercise program, verified by the ESS, and the adherence of the subjects to the program. Conclusions: We hope that through this study, we can show that the regular practice of semi-supervised home exercises is effective in improving sleep quality and reducing excessive daytime sleepiness in sedentary elderly people and can be considered as a therapeutic, safe, easy-to-implement, and low-cost non-pharmacological resource.

Randomized Controlled Trials of Electronic Health Record Interventions: Design, Conduct, and Reporting Considerations.

Electronic health record (EHR) systems can be configured to deliver novel EHR interventions that influence clinical decision making and to support efficient randomized controlled trials (RCTs) designed to evaluate the effectiveness, safety, and costs of those interventions. In designing RCTs of EHR interventions, one should carefully consider the unit of randomization (for example, patient, encounter, clinician, or clinical unit), balancing concerns about contamination of an intervention across randomization units within clusters (for example, patients within clinical units) against the superior control of measured and unmeasured confounders that comes with randomizing a larger number of units. One should also consider whether the key computational assessment components of the EHR intervention, such as a predictive algorithm used to target a subgroup for decision support, should occur before randomization (so that only 1 subgroup is randomized) or after randomization (including all subgroups). When these components are applied after randomization, one must consider expected heterogeneity in the effect of the differential decision support across subgroups, which has implications for overall impact potential, analytic approach, and sample size planning. Trials of EHR interventions should be reviewed by an institutional review board, but may not require patient-level informed consent when the interventions being tested can be considered minimal risk or quality improvement, and when clinical decision making is supported, rather than controlled, by an EHR intervention. Data and safety monitoring for RCTs of EHR interventions should be conducted to guide institutional pragmatic decision making about implementation and ensure that continuing randomization remains justified. Reporting should follow the CONSORT (Consolidated Standards of Reporting Trials) Statement, with extensions for pragmatic trials and cluster RCTs when applicable, and should include detailed materials to enhance reproducibility.

CONSORT endorsement improves the quality of reports of randomized clinical trials in dentistry

ObjectivesThis study aimed to assess if the Consolidated Standards of Reporting Trials (CONSORT) endorsement by journals is associated with improved completeness of reporting of randomized clinical trials (RCTs) in dentistry. Study Design and SettingWe searched for RCTs in dentistry indexed/published on PubMed in 2017. Study selection was undertaken by two reviewers independently. Data related to the general characteristics, reports of methodological characteristics, and whether the trial report was published in a journal that endorses the CONSORT Statement were extracted by two reviewers. Descriptive statistics were used to present the data surrounding the general and methodological characteristics of the included studies. We explored differences in the reporting of 12 methodological items between journals that endorsed CONSORT and those that did not. ResultsFive hundred and thirty three reports were included. The main area was implant dentistry with 101 articles (18.9%). Most studies had a parallel design (75.8%), performed at a single center (89.3%) and presenting two groups of comparison (75.6%). The median number of sample size was 50 (interquartile range: 31-90). Six of the 12 methodologic items were reported more often for RCTs published in journals that endorsed CONSORT than in journals that did not. ConclusionCONSORT endorsement by journals is linked to improvement in the quality of RCT reports in dentistry.

Standards for reporting interventions in clinical trials of cupping (STRICTOC): extending the CONSORT statement

BackgroundThe standards for reporting interventions in clinical trials of cupping (STRICTOC), in the form of a checklist and explanations for users, were designed to improve reporting of cupping trials, particularly the interventions, and thereby facilitating their interpretation and replication.MethodsA group of clinical experts, methodologists, epidemiologists, and editors has developed this STRICTOC checklist through a comprehensive process, including registration of this guideline, literature review, solicitation of comments, consensus meeting, revision, and finalization.ResultsThe STRICTOC checklist includes 6 items and 16 sub-items, namely cupping rationale, details of cupping, treatment regimen, other components of treatment, treatment provider background, and control or comparator interventions. Illustrative examples of each item are also provided.ConclusionsIt is intended that the STRICTOC, in conjunction with both the main Consolidated Standards of Reporting Trials (CONSORT) Statement and extension for nonpharmacologic treatment, will raise the reporting quality of clinical trials of cupping.Trial registration We have registered this study on the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#STRICTOC.

Using Bluetooth beacon technology to reduce distracted pedestrian behaviour: a cross-over trial study protocol

ObjectiveOver 6400 American pedestrians die annually, a figure that is currently increasing. One hypothesised reason for the increasing trend is the role of mobile technology in distracting both pedestrians and...

Toward Better Reporting Standards of Patients' Characteristics in Rehabilitation Trials: Applying a New Conceptual Framework to Current Standards.

The reporting of clinical studies in rehabilitation has been criticized in several aspects, including the reporting of patient characteristics. This article aims to contribute to the improvement of the reporting of patient characteristics in rehabilitation trials. Specifically, we want to determine the type of information that should be reported in rehabilitation trials that is specific to rehabilitation patients and how this information is captured by current reporting standards. In the first step, we made a conceptual analysis of characteristics of rehabilitation patients by addressing the specifics of the field of medical rehabilitation, including the definition of rehabilitation and a description of its beneficiaries. In the second step, we compared this reference framework to the current reporting standards, especially the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions, as well as standards for the reporting of clinical guidelines (agree, right). Patients included in rehabilitation interventions should be distinguished by specific information. From a clinical perspective, patients dealt with in rehabilitation comprise broader diagnostic groups compared with other clinical settings. Information on comorbidities should be added in the description of the patients. In addition, a description of baseline characteristics of patients should always include functioning characteristics of the patients, including information on relevant context factors, ie, environmental and personal factors. The CONSORT statement aims to provide patient characteristic to enable transferability of results to users. It is represented in terms of selection (inclusion/exclusion) criteria and the description of the resulting samples. Extensions of the CONSORT statement specified that information on socioeconomic variables should be added, and the selection of patient characteristics to be reported at baseline should be based on the selection of outcome variables. In addition, all relevant prognostic variables should be reported. Only one CONSORT extension asks explicitly to include comorbid conditions. The reporting standards on guidelines demand a more comprehensive characterization of patients, specific to the rehabilitation area. Present reporting standards can only partly address relevant issues pertinent to medical rehabilitation. The present analysis provides a conceptual and empirical framework for the development of reporting standards on patient characteristics in rehabilitation trials.