Consolidated Standards Of Reporting Trials Research Articles

A Meta-Analysis Investigating the Efficacy and Safety of Allergen-Specific Immunotherapy in the Management of Respiratory Allergies

Background: This meta-analysis aimed to evaluate the effectiveness and adverse effects of specific immunotherapy (SIT) in the management of respiratory allergens, including allergic asthma, rhinitis, and related disorders, based on a review of current literature up to November 8, 2022. Methods: We conducted a search of databases, including PubMed, Embase, Cochrane, and Web of Science, to identify relevant randomized controlled trials (RCTs) assessing respiratory allergy-specific immunotherapy. We employed the Consolidated Standards of Reporting Trials (CONSORT) Statement to select RCTs that adhered to rigorous reporting standards. Specifically, we focused on double-blind placebo-controlled (DBPC) trials and open studies involving both adults and children, considering factors such as dosage, inclusion criteria, allergens, and primary outcome measurements. Results: A total of 25 meta-analyses were included in this study. Among them, 14 evaluated sublingual specific allergen immunotherapy (SLIT), 4 assessed subcutaneous allergen immunotherapy (SCIT), 4 explored both sublingual and subcutaneous immunotherapy, and 3 investigated intralymphatic immunotherapy. The outcomes of these meta-analyses indicated a reduction in medication scores in 20 cases and a decrease in symptom scores in 23 cases. Additionally, six studies reported on changes in IgE levels, seven studies focused on IgG4, four studies examined FEV1 (forced expiratory volume in one second), and eight studies reported on symptom and medication scores. Furthermore, eleven studies reported on differences in adverse reactions. Conclusion: The results of our meta-analysis suggest that specific immunotherapy, while associated with some adverse effects, effectively reduces the symptoms of asthma and rhinitis. Therefore, we recommend its use in the treatment of respiratory allergies.

Reporting quality of heart failure randomized controlled trials 2000-2020: Temporal trends in adherence to CONSORT criteria.

Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high-impact journals by assessing their adherence to CONSORT. We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high-impact journals 2000-2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere-Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20-year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (β = 10.17, 95% confidence interval [CI] 7.64-12.70; p < 0.001); two-group parallel individual-level randomization versus other (including multi-group or cluster randomization) (β = 5.81, 95% CI 2.88-8.73; p < 0.001); and multicentre versus single-centre trials (β = 7.26, 95% CI 3.25-11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal.

Diclofenac Transdermal Patch versus Oral Diclofenac on Post Endodontic Pain and Quality of Life- A Randomised Clinical Trial.

To compare the effect of pre-treatment transdermal and oral diclofenac on post-endodontic pain level and oral health-related quality of life (OHRQOL) in patients with symptomatic irreversible pulpitis with apical periodontitis in mandibular molars following single visit root canal treatment. This parallel-arm, randomised, double-blinded clinical trial is reported according to the Consoli-dated Standards of Reporting Trials (CONSORT) 2020 guidelines. The protocol was approved by the Institu-tional Ethical Committee on 30th March 2021 (MADC/IEC-I/029/2021) and registered at the clinical trial reg-istry of India (CTRI/2021/12/038696). Adult patients fulfilling the eligibility criteria were randomised into two groups. Group DTP received a diclofenac transdermal patch 100 mg, and Group DOT received a diclofenac oral tablet 100 mg one hour before root canal treatment. Pain scores were checked at baseline, 2, 4, 6, 8, 24, 48, and 72 hours after the treatment. OHRQOL was assessed at baseline and one week after the treatment. Both groups were associated with a significantly lower incidence of post-operative pain and im-proved OHRQOL. At 2 hours, the pain level was significantly lower with an oral diclofenac tablet, and at 24 hours, the pain level was significantly lower with a diclofenac transdermal patch. Regarding OHRQOL, there was no significant difference between the two groups. Within the limitations of this study, the diclofenac transdermal patch had lesser post-operative pain at 24 hours, whereas the oral diclofenac tablet had lesser pain at 2 hours.

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...

The Effect of Preventive Nursing Interventions on Reduction of Obesity Risk University Students: A Randomized Controlled Trial

Objective: The aim of the study was to assess the effect of an obesity prevention program to decrease obesity risk on university students at risk.&#x0D; Methods: This is a parallel-group randomized controlled trial that is suitable for the Consolidated Standards of Reporting Trials (CONSORT) statement. The study was carried out at a University in Turkey. The study participants were 70 students (experiments 35 and control 35). The obesity prevention program, which includes education and practices about eating habits and physical activity, and motivational messages,&#x0D; was implemented for 11 weeks. Nutrition training attitude score, exercise nutrition behavior score and exercise benefit/barrier score, body mass index, waist size ratio, and body fat percentage are the outcomes of the research. Dependent samples t-test, independent t-test, and intention to treat (ITT) were used for data analysis.&#x0D; Results: The difference between the experimental group and the control group was statistically significant in attitude and behavior of nutrition exercise (p

Comparison of low-dose maximal-intent versus controlled-tempo resistance training on quality-of-life, functional capacity, and strength in untrained healthy adults: a comparative effectiveness study

Lack of physical activity is a global issue for adults that can lead to sedentary behaviour and a higher prevalence of health complications and chronic diseases, resulting in reduced quality-of-life (QoL) and functional capacity (FC). A potential strategy to mitigate this inactivity is low-dose resistance training (RT); however, physiological, and psychological responses are limited in evidence. Twenty untrained participants aged 30–60 years old (mean ± SD age 42 ± 7 years, mass 77 ± 13 kg, stature 166 ± 8 cm; 18 females and two males) were recruited and randomly assigned to maximal velocity-intent (MI, n = 10) or controlled-tempo (CT, n = 10) RT according to CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Participants attended one training session per week for 6 weeks, consisting of five sets of five repetitions at 60% of one-repetition maximum (1RM) leg press. The interventions differed only during the concentric phase, with MI group pushing with maximal intent, and CT group pushing in a time-controlled manner (3 s). Outcome measures assessed pre- and post-RT included body mass, body mass index (BMI), strength-to-mass ratio, bipedal balance, 6-minute walk test (6MWT), 30-second sit-to-stand (30s-STS), timed up and go (TUG), and leg press 1RM. Time effects were observed for all demographics and FC-related outcomes, such as identical reductions in mass and BMI (− 2%), improvements in strength-to-mass ratio (25%) leg press 1RM (22%), 6MWT (3%), and 30s-STS (14%), as well as a 9% improvement in both TUG-clockwise and anticlockwise. Results show low-dose once-weekly RT is effective in improving QoL, FC, and strength in untrained healthy adults, regardless of modality. Positive responses from participants suggest an increased likelihood of consistent participation for low-dose once-weekly RT over more intense modalities. Retrospective ClinicalTrials.gov ID (TRN): NCT06107855, 24/10/2023.

Quality reporting of randomized controlled trials on SGLT2 inhibitors for heart failure: a comprehensive assessment

Randomised controlled trials (RCTs) provide clinicians with the best evidence of the effectiveness of an intervention, and complete and transparent trial reports help to critically assess and use trial results. The objective of our study was to assess the quality of reporting in RCTs of sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for heart failure (HF) and identify factors associated with improved reporting quality. Two researchers conducted a comprehensive search in four databases (PubMed, Web of Science, EMBASE, and Cochrane). The quality of each report was assessed using a 25-point Overall Quality Score (OQS) based on the guidelines provided in the 2010 Consolidated Standards for Reporting of Trials (CONSORT) statement. We included a total of 58 relevant RCTs. The median OQS in the 2010 CONSORT statement was 15 (range 7.5–24). The missing items were primarily found in the 'Methods' and 'Results' sections of the 2010 CONSORT statement. Multivariate regression modeling revealed that a more recent publication year, high impact factor, and large sample size were significant predictors of OQS improvement. The findings suggest that the overall quality of reported RCTs of SGLT2 inhibitors in HF is unsatisfactory, which reduces their potential usefulness.

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.

From Basic Science to Clinical Practice: A Review of Current Periodontal/Mucogingival Regenerative Biomaterials.

Periodontitis is a dysbiosis-driven inflammatory disease affecting the tooth-supporting tissues, characterized by their progressive resorption, which can ultimately lead to tooth loss. A step-wise therapeutic approach is employed for periodontitis. After an initial behavioral and non-surgical phase, intra-bony or furcation defects may be amenable to regenerative procedures. This review discusses the regenerative technologies employed for periodontal regeneration, highlighting the current limitations and future research areas. The search, performed on the MEDLINE database, has identified the available biomaterials, including biologicals (autologous platelet concentrates, hydrogels), bone grafts (pure or putty), and membranes. Biologicals and bone grafts have been critically analyzed in terms of composition, mechanism of action, and clinical applications. Although a certain degree of periodontal regeneration is predictable in intra-bony and class II furcation defects, complete defect closure is hardly achieved. Moreover, treating class III furcation defects remains challenging. The key properties required for functional regeneration are discussed, and none of the commercially available biomaterials possess all the ideal characteristics. Therefore, research is needed to promote the advancement of more effective and targeted regenerative therapies for periodontitis. Lastly, improving the design and reporting of clinical studies is suggested by strictly adhering to the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.

The effect of virtual reality and music on anxiety, non-stress test parameters, and satisfaction of high-risk pregnant women undergoing non-stress tests: Randomized controlled trial

BackgroundPrenatal tests cause high-risk pregnant women to experience high anxiety levels. AimThis paper investigated the effect of Virtual Reality (VR) and music on anxiety, non-stress test parameters, and satisfaction of high-risk pregnant women undergoing non-stress tests (NSTs). MethodsThis was a randomized controlled trial. The sample consisted of 102 participants randomized into three groups (VR = 34, music = 34, and control = 34). Maternal anxiety was assessed using the Spielberger State-Trait Anxiety Inventory-S (STAI-S) before and after NSTs. Satisfaction was evaluated using the Visual Analogue Scale (VAS) after NSTs. NST parameters were evaluated after NSTs. The findings were reported based on the Consolidated Standards of Reporting Trials (CONSORT). ResultsThe VR and music groups had significantly lower mean posttest STAI-S scores than the control group (p <.05). There was no significant difference in NST findings (reactive/nonreactive) between the groups (p >.05). The VR group had a significantly shorter reactive NST duration than the control group (p <.05). The VR and music groups had significantly higher mean VAS-satisfaction scores than the control group (p <.05) ConclusionVirtual reality and music during NSTs help high-risk pregnant women experience less anxiety and satisfy them more with the procedure. We recommend that obstetric midwives and nurses use these low-cost, simple, and noninvasive methods to reduce anxiety in high-risk pregnant women during prenatal testing.

Two-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations: a randomized clinical trial

ObjectiveThis study aimed to compare the clinical performance of dual- and light-cure bulk-fill resin composites (BFRCs) in Class ӀӀ restorations after 2 years.Materials and methodsA double-blinded, prospective, randomized clinical trial (RCT) was conducted following the CONSORT (Consolidated Standard of Reporting Trials) guidelines. Forty patients were enrolled in the study. Each patient received three compound Class ӀӀ restorations. One dual-cure (Fill-Up; Coltene Waledent AG) and two light-cure (QuiXfil; Dentsply, and Tetric N-Ceram Bulk Fill; Ivoclar Vivadent) BFRCs were used for 120 Class ӀӀ restorations. A universal adhesive (ONE COAT 7 UNIVERSAL; Coltene Waledent AG) was used with all restorations. Restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months, and finally after 24 months using the FDI World Dental Federation (FDI) criteria. The Kruskal–Wallis test was used for comparison between BFRCs groups at baseline and at each recall period, and the Wilcoxon signed-rank test was used for comparing different follow-up times of each BFRC to baseline. The level of significance was set at p < 0.05.ResultsAll BFRCs restorations showed only minor changes and revealed no statistically significant differences between their clinical performance for all evaluated parameters at all recall periods; also, there was no statistically significant difference between all recall periods and baseline for all evaluated parameters.ConclusionThe two-year clinical performance of dual-cure BFRC was comparable to light-cure BFRCs in Class ӀӀ restorations.Clinical relevanceDual- and light-cure BFRCs showed excellent clinical performance in Class ӀӀ restorations after a 2-year clinical follow-up.

INTENTION TO TREAT ANALYSIS IN CLINICAL RESEARCH: BASIC CONCEPTS FOR CLINICIANS.

This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. Additionally, we included studies from manual searches that were already cataloged within the first author's personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

BackgroundDespite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C).MethodsThe development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to “lock” the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12–24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations.DiscussionSPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste.Trial RegistrationThe development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35) and CONSORT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD).

Clinical trials of pharmacological interventions for SARS-CoV-2 published in leading medical journals report adherence but not how it was assessed.

Adherence to pharmacological interventions in clinical trials is crucial for accurate identification of beneficial and adverse outcomes. The ways in which adherence to interventions should be reported in trial publications are described in the Template for Intervention Description and Replication (TIDieR), a 12-item extension of the Consolidated Standards of Reporting Trials reporting guidelines. The objective of this study was to assess compliance with TIDieR Items 11 and 12 of randomized controlled trials (RCTs) of interventions in SARS-CoV-2 infection published in 5 selected journals during 2021. We assessed pharmacological interventions for SARS-CoV-2 infection reported in RCTs published in 2021 in the Annals of Internal Medicine, The BMJ, JAMA, The Lancet and The New England Journal for Medicine for compliance with TIDieR items addressing intervention adherence (Items 11 and 12). We calculated proportional adherence for pharmacological and comparator interventions where available. We found 75 eligible RCTs. Twenty-eight (37%) reported results of SARS-CoV-2 vaccinations. Compliance with Items 11 and 12 could be assessed in 71 of these 75. Of the 71 RCTs, 37 (52%) reported how adherence was assessed (Item 11), and 70 reported adherence rates (Item 12). Only 1 of the 71 RCTs (1.4%, 0-7.6%) fully complied with TIDieR Items 11 and 12. Half of RCTs of SARS-CoV-2 pharmacological interventions published in leading medical journals in 2021 complied with reporting of how adherence assessments were made and almost none complied with both TIDieR Items 11 and 12. The implications for interpretation, application and replication of findings based on these publications warrant consideration.

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.

Evaluation of Reporting Quality of Glaucoma Randomized Controlled Trial Abstracts: Current Status and Future Perspectives.

The aim of this study was to explore adherence to the Consolidated Standards of Reporting Trials (CONSORT) reporting standards in abstracts of randomized controlled trials on glaucoma. A cross-sectional observational study was conducted on the aforementioned abstracts, indexed in MEDLINE/PubMed between the years 2017 and 2021. In total, 302 abstracts met the inclusion criteria and were further analyzed. The median score of CONSORT-A items was 8 (interquartile range, 7-10) out of 17 (47.0%). Most analyzed studies were conducted in a single center (80.5%) and the abstracts were predominantly structured (95.0%). Only 20.5% of the abstracts adequately described the trial design, while randomization and funding were described by 6.0% of the abstracts. Higher overall scores were associated with structured abstracts, a multicenter setting, statistically significant results, funding by industry, a higher number of participants, and having been published in journals with impact factors above four (p < 0.001, respectively). The results of this study indicate a suboptimal adherence to CONSORT-A reporting standards, especially in particular items such as randomization and funding. Since these factors could contribute to the overall quality of the trials and further translation of trial results into clinical practice, an improvement in glaucoma research reporting transparency is needed.

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.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, eg, External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONsolidated Standards of Reporting Trials (CONSORT) 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Identifying the Anatomical Variations of the Inferior Alveolar Nerve with Magnetic Resonance Imaging.

The inferior alveolar nerve (IAN) is located in the mandibular canal (MC). It is critical to evaluate the position of the MC during treatment planning to prevent intra or postoperative complications. This retrospective study aimed to identify the anatomy and anatomical variations of the IAN using soft tissue imaging (pulse sequence magnetic resonance imaging [MRI]). This study was designed as a retrospective Consolidated Standards of Reporting Trials (CONSORT) study. In total, 220 MR images were obtained. Nutrient canals (NCs) were classified as intraosseous and dental NCs, while bifid MCs (BMCs) were classified as forward, retromolar, and buccolingual canals. IBM SPSS Statistics 22 was used. Kolmogorov-Smirnov and Shapiro-Wilk tests, descriptive statistical methods (means, standard deviations, and frequencies), and the Chi-square test were used. Statistical significance was set at P < 0.05. In total, 220 patients (172 females and 48 males) were evaluated. NCs were present in 92.3% of all MCs and were significantly higher in patients aged <25 years. BMCs were observed in 106 patients (24.1%). The most common BMC of MC/IAN was in the forward canal (14.4%), followed by the retromolar canal (7.5%). Although previously, the dental canal was considered as an anatomical variation, this study revisited the classification and suggested that dental canals are anatomical structures.

Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery

PurposeThis study aims to determine the effect of introducing the operating room environment with different informative multimedia methods to pediatric patients aged 7–12 in the preoperative period in day surgery on fear, pain, and patient satisfaction in three different groups comparatively. Design and methodsThis randomized controlled study was conducted with the guidelines of Consolidated Standards of Reporting Trials (CONSORT). The sample of children was allocated to the Short Film Group (n:30), Video Based Education Group (n:30) and Control Group (n:30). Fear, pain, and satisfaction were measured. ResultsThe age distribution of the children in the study was 7.57 ± 1.25 years in the short film group, 7.27 ± 0.52 years in the video-based education group, and 7.57 ± 2.27 years in the control group. There was no significant difference between the groups in terms of demographic status, fear, and vital signs before the procedure. Fear, pain, and satisfaction levels of children in short film groups were lower than video-based education groups. ConclusionThe result of this research reveals that preoperative short film education in children is more effective than video-based education in reducing fear, pain, and satisfaction levels. This intervention could be an effective method to improve outcomes. Nurses can increase children's comfort by using educational programs that attract children's attention. Practice implicationsHealthcare team members working in pediatric surgical units can use the short film method, which is effective, easy, and applicable in the field, to reduce pain and fear in the preoperative period and increase satisfaction in children undergoing day surgery.