Consolidated Standards Of Reporting Trials Research Articles

CONSORT 2025 statement: updated guideline for reporting randomized trials.

Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-Pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (such as personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.

CONSORT 2025 statement: Updated guideline for reporting randomised trials.

Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.

CONSORT 2025 statement: updated guideline for reporting randomised trials.

CONSORT 2025 statement: updated guideline for reporting randomised trials.

Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022.

Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022.

Efficacy of D33 Sealed Foam in Preventing Skin Injury from Surgical Positioning: Randomized Clinical Trial.

Objective: To evaluate the efficacy of density-33 (D33) sealed foam in preventing skin injuries from surgical positioning. Approach: The study, reported according to the Consolidated Standards of Reporting Trials, is characterized as a randomized clinical trial, double mask, with 64 adult patients undergoing elective surgery, 35 allocated to the control group (CG), positioned on a conventional surgical table, and 29 to the experimental group (EG), positioned on a conventional surgical table overlaid with a D33 sealed foam support surface (SS) in the occipital, sacral, and heel regions. Simple randomization was carried out, as was masking of the researcher who evaluated the skin of the patient and the statistician. Data collection was carried out immediately preoperatively, intraoperatively, and postoperatively until the third day or until patient discharge. Statistical analysis included measures of association in contingency tables, χ2, and relative risk to compare the incidence of injuries between groups. Results: Skin injuries were greater in the CG, with blanchable erythema being the main injury. The use of D33 sealed foam reduced the incidence of injury in the EG by 61.2% (relative risk: 0.39; 95% confidence interval: 0.220-0.684; p < 0.001). Innovation: One of the first clinical studies to demonstrate that using a D33 sealed foam SS decreased the incidence of blanchable erythema from surgical positioning. Conclusion: D33 sealed foam was effective in preventing skin injury from surgical positioning in patients undergoing elective surgeries.

Establishment of a National Surgical Tissue Biobank for Pediatric Crohn's Disease: An Implementation Feasibility Study.

Establishment of a National Surgical Tissue Biobank for Pediatric Crohn's Disease: An Implementation Feasibility Study.

The effect of MediYoga on sleep-quality, blood pressure and quality of life among older people with hypertension: study protocol of a pragmatic randomized controlled trial

BackgroundHigh blood pressure (BP) is a common condition that is estimated to soon affect one third of the worlds’ population. Poor subjective sleep quality is shown to be associated with an elevated risk of high BP, though it is a risk factor that can be modified. Yoga can be used as a complementary therapy to lower BP, but more knowledge on duration and intensity are needed. The overall aim is to test the effect of an online yoga intervention as a complementary therapy. The objectives are to: (1) Test whether online yoga can improve sleep quality, health related quality of life, and lower BP. (2) To explore and describe the implementation of online yoga and the participants’ experiences and perspectives on the intervention in a process evaluation.MethodsA pragmatic randomized controlled trial will be conducted. The study is described in accordance with the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials) and results will be reported following the CONSORT (CONsolidated Standards Of Reporting Trials) guidelines for pragmatic trials. The study is designed as a three arm, randomized superiority trial. Inclusion criteria: ≥65 years old, diagnosed with high BP, speaking and reading Danish, able to consent, no comorbidity that restricts them from participating in the intervention, and daily access to a smartphone or tablet. Participants will be randomly assigned to (i) control group which will be receiving treatment as usual (TAU), or to one of two intervention-groups (ii) performing yoga twice a week for 20 min (20 MIN) or (iii) 40 min (40 MIN) for a total of 10 weeks in addition to TAU. The primary outcome is sleep quality measured by the Pittsburg Sleep Quality Index and secondary outcomes include health related quality of life and BP. Analysis will present differences between groups and be carried out by a statistician blinded to group allocation.DiscussionThe study is grounded in the urgent need to address high BP since pharmacological interventions remain the primary treatment modality, the exploration of non-pharmacological strategies, such as yoga, offers a promising avenue for enhancing patient outcomes in a holistic manner.Trial registrationClinicalTrials.gov ID NCT06553820. Protocol version 1. 13th November 2024.

Efficacy of short message service (SMS) intervention on medication adherence and knowledge of stroke prevention among clinic attendees at risk of stroke: a randomized controlled trial

BackgroundStroke remains a leading cause of long-term disability and mortality worldwide, particularly in low- and middle-income countries where suboptimal management of modifiable risk factors such as hypertension and diabetes mellitus are prevalent. Poor medication adherence, a critical barrier to effective risk management, is widespread in Nigeria, with adherence rates below 50% in patients with chronic illnesses. This study evaluates the efficacy of a 12-week short message service (SMS)-based intervention in improving medication adherence, knowledge, and prevention practices among hypertensive and diabetic patients attending the Medical Outpatient Clinic at the University College Hospital, Ibadan, Nigeria.MethodologyA single-center randomized controlled trial was conducted with 150 participants aged 18 years and above and had a documented clinical diagnosis of hypertension and/or diabetes mellitus and currently being treated with a prescribed medication. The intervention group received bi-daily SMS reminders on medication adherence, lifestyle modifications, and stroke prevention, alongside standard care. The control group received standard care only. Outcomes assessed included change in medication adherence, knowledge, stroke prevention practices, and quality of life. A p value of 0.05 was used.ResultThe prevalence of hypertension and diabetes were 90.0% and 20.7% respectively; 16 individuals (10.7%) had comorbidity of hypertension and diabetes. There was a 14.7% increase in the proportion of participants with a high medication adherence in the intervention arm whereas the control arm had a 2.7% increase. This 5 times relative increase in proportion was however not statistically significant. The study showed a significant effect of the intervention on participants knowledge of stroke prevention (t = 3.339, p = 0.001). There was no significant impact of the intervention on self-rated health scores (t = 0.132; p = 0.896).ConclusionThe SMS intervention significantly improved stroke prevention knowledge and showed a non-significant trend towards better medication adherence. Baseline motivational and cultural factors likely influenced outcomes, underscoring the need to address behavioral, cultural and economic barriers. This scalable telehealth model warrants further exploration to optimize adherence in resource-limited settings.Clinical trial registrationThis study was registered on the 25th July and approved on 25th of August 2023 by the Pan African Clinical Trials Registry (PACTR) with unique identification number: PACTR202308767234235. The findings from this study are presented in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement.

A Smaller Sample Size Is Associated With Lower Rates of Reporting of Harms in Randomized Controlled Trials Cited in the AAOS Clinical Practice Guidelines for Anterior Cruciate Ligament Injuries

Background: Randomized controlled trials (RCTs) significantly influence clinical decision-making, necessitating comprehensive reporting of trial outcomes. However, previous studies have demonstrated that reporting of harms among RCTs is often inadequate. Purpose/Hypothesis: The purpose of this study was to evaluate reporting of harms among RCTs cited within the American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines (CPGs) for anterior cruciate ligament (ACL) injuries, with an emphasis on study characteristics associated with adherence. We hypothesized that >50% of these trials would have incomplete adherence to the checklist items outlined in the Consolidated Standards of Reporting Trials (CONSORT) extension for harms and that a larger sample size would be associated with greater compliance. Study Design: Cross-sectional study. Methods: We identified RCTs cited in the AAOS CPGs for the management of ACL injuries and assessed compliance with the 18-item CONSORT extension for harms checklist. Descriptive statistics were used to summarize overall adherence to the checklist items, and linear regression analysis evaluated adherence over time. Results: Our analysis included 116 RCTs, the majority of which were single-center studies (81.0%). Most trials had sample sizes of 50-100 patients (45.7%) or 101-500 patients (37.9%). On average, trials adhered to 9.25 of 18 CONSORT items (51.4%), with the most compliant study meeting 15 of 18 items (83.3%) and the least compliant meeting 3 of 18 items (16.7%). Overall, 18 RCTs (15.5%) reported ≤33% of items, and 22 RCTs (19.0%) reported ≥67% of items. Studies with >500 patients had significantly higher adherence compared with studies with <50 patients (P = .046). There was no significant difference in adherence based on the disclosure of funding sources (P = .85) or the implementation of blinding (P = .37). Interrupted time series regression analysis demonstrated no significant change in reporting both before (R2 = 0.017; P = .62) and after (R2 = 0.21; P = .16) the release of the checklist in 2004. Conclusion: On average, RCTs cited within the AAOS CPGs for the management of ACL injuries adhered to 51.4% of CONSORT checklist requirements, with considerable variability across studies. Improvements in reporting practices are warranted to support evidence-based treatment decisions.

Mapping Perioperative Care Randomized Controlled Trials in Sub-Saharan Africa: A Scoping Review.

The World Health Organization has recognized surgical and anesthesia care as integral components of universal health coverage. In sub-Saharan Africa (SSA), 93% of the population lacks access to essential surgical services. Postsurgery mortality in Africa is double the global average. The involvement of anesthesia providers is crucial for improved outcomes. Perioperative research can produce context-specific solutions to challenges faced in the perioperative period. SSA conducts fewer randomized controlled trials (RCTs) than high-income countries, limiting its contribution to global evidence. Our primary objectives were to document the geographical distribution of included RCTs, describe their characteristics, and evaluate the reporting quality using the Consolidated Standards of Reporting Trials (CONSORT)-2010 checklist. We followed the PRISMA Scoping Reviews (PRISMAScR) Checklist. We searched MEDLINE, the Cochrane Library, and Scopus. We identified perioperative care RCTs within SSA published from 2000 to 2022. Two independent reviewers screened potential studies and extracted data in duplicate, with disagreements resolved through consensus or a third reviewer. Quantitative analysis was done with STATA 16, and data were summarized narratively. We compared RCT quality pre-CONSORT-2010 to post-CONSORT-2010, using Pearson's χ2 test or Fisher exact test (as applicable), considering P < .05 as statistically significant. Of 3319 records, 169 eligible RCTs were identified, randomizing 45,376 participants, with a mean sample size of 98. Between the years 2000 and 2022, there was an exponential trend towards an increasing number of RCTs in SSA (y = 1,5619e0,1051x). The RCTs were from 16 countries in SSA. Most studies were single-country, single-center, led by authors from Nigeria (63/169, 37.3 %) and South Africa (41/169, 24.3%). Most interventions were conducted intraoperatively (n = 125/169, 74%). Pharmacotherapy interventions were most investigated (n = 64/169, 37.9%), followed by analgesic interventions (n = 42/169, 24.9%). The surgical discipline most investigated was obstetrics (n = 51/169, 30.2%). The reporting quality was generally poor, with most RCTs not adhering to CONSORT guidelines and failing to register on a trial registry. This scoping review provides a comprehensive overview of perioperative care RCTs in SSA, highlighting limitations such as small sample sizes, under-representation of high surgical burden disciplines, and poor outcome reporting. Clinical trial capacity is limited to a few countries and institutions, and methodological quality remains poor despite reporting guidelines. There is an opportunity to enhance context-appropriate RCTs in SSA by prioritizing high-quality research through collaborative efforts. Our findings serve as a resource for researchers, funders, and policymakers in perioperative care research in Africa to improve future RCT designs and reporting.

AI-Powered Image-Based Assessment of Pressure Injuries Using You Only Look once (YOLO) Version 8 Models.

Objective: The primary objective of this study is to enhance the detection and staging of pressure injuries using machine learning capabilities for precise image analysis. This study explores the application of the You Only Look Once version 8 (YOLOv8) deep learning model for pressure injury staging. Approach: We prepared a high-quality, publicly available dataset to evaluate different variants of YOLOv8 (YOLOv8n, YOLOv8s, YOLOv8m, YOLOv8l, and YOLOv8x) and five optimizers (Adam, AdamW, NAdam, RAdam, and stochastic gradient descent) to determine the most effective configuration. We followed a simulation-based research approach, which is an extension of the Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for dataset preparation and algorithm evaluation. Results: YOLOv8s, with the AdamW optimizer and hyperparameter tuning, achieved the best performance metrics, including a mean average precision at intersection over union ≥0.5 of 84.16% and a recall of 82.31%, surpassing previous YOLO-based models in accuracy. The ensemble model incorporating all YOLOv8 variants showed strong performance when applied to unseen images. Innovation: Notably, the YOLOv8s model significantly improved detection for challenging stages such as Stage 2 and achieved accuracy rates of 0.90 for deep tissue injury, 0.91 for Unstageable, and 0.74, 0.76, 0.70, and 0.77 for Stages 1, 2, 3, and 4, respectively. Conclusion: These results demonstrate the effectiveness of YOLOv8s and ensemble models in improving the accuracy and robustness of pressure injury staging, offering a reliable tool for clinical decision-making.

Protocol for a randomised controlled feasibility trial of an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis: the PIMS trial

BackgroundMultiple Sclerosis (MS) is a long-term condition that significantly diminishes quality of life (QoL). Sexual difficulties (SDs) are common, but often overlooked symptom, affecting 50–80% of people with MS (PwMS). The emergence of SDs in MS results from the intricate interplay of disease processes, treatments, and psychosocial factors, contributing to a further decline in QoL and adverse effects on body image, relationships, and psychological well-being. Despite the limited treatment options, which mainly include medications and physiotherapy, there is promise in psychological interventions for addressing SDs in PwMS, although integrating them into routine care poses challenges. This protocol details the trial assessing the acceptability and feasibility of an eight-session, clinicians supported integrated Psychosexual Intervention for people with Multiple Sclerosis (PIMS).MethodsThis is a multicentre interventional two-arm randomized feasibility trial with a nested qualitative study to gather preliminary data about the intervention and the feasibility of conducting a full-scale trial. We aim to recruit 50 PwMS across three research sites in England’s National Health Service (NHS). Participants will be randomised to either the PIMS intervention (comprised of 8 sessions: 6 self-led and 2-facilitator led over the course of 12 weeks) or psychosexual education (one appointment with a facilitator to discuss treatment options). Feasibility will be assessed by collecting descriptive data on recruitment and retention rates and willingness to be randomised according to Consolidated Standards of Reporting Trials (CONSORT) feasibility and pilot trial guidelines. Patient reported outcomes (e.g., measures of sexual functioning and distress, psychological functioning, and quality of life) will be measured at baseline and follow up 14-weeks after randomisation. We will also use a nested qualitative study will use inductive thematic analysis to identify barriers to engagement with and delivery of the intervention, and to make appropriate modifications to PIMS.DiscussionThe PIMS intervention will be the first integrated psychosexual intervention developed for people with Multiple Sclerosis in the UK. Assessing the feasibility of PIMS is an important first step to establishing future implementation and efficacy via a definitive randomised controlled trial.Trial registrationThis trial is registered at ISRCTN: 12202900.Registration date: 28th February 2023; Retrospectively registered.IRAS identification: 305830.NIHR award reference: NIHR202006.Trial sponsorship: This trial is co-sponsored by South London and Maudsley NHS Foundation Trust and King’s College London. Contact: slam-ioppn.research@kcl.ac.uk.Protocol version: 2.0, 10th February, 2025

Assessment of Adherence to Consolidated Standards of Reporting Trials 2010 Guidelines of Randomized Controlled Trials Published in an Indian and International Pharmacology Journal From 2019 to 2023.

Randomized controlled trials (RCTs) are considered the gold standard in clinical research, providing the highest level of evidence for the effectiveness of healthcare interventions. However, the validity and utility of RCTs depend on the quality of their design, conduct, and reporting. The purpose of this review was to assess the adherence of RCTs published in Indian and international pharmacology journals to the Consolidated Standards of Reporting Trials (CONSORT) statement. RCTs published from 2019 to 2023 from one Indian and one international pharmacology journal were assessed using the CONSORT 2010 checklist, and the items were assigned as "present" or "absent." Data was analyzed using descriptive statistics, and chi-square and Fisher's exact tests were used for categorical data. A total of 61 articles were analyzed, out of which 31 and 30 articles belonged to international and Indian journals, respectively. RCTs published in international journals consistently showed higher adherence rates compared to Indian journals, with statistically significant differences for several checklist items, including trial design description (31, 100%), intervention details (31, 100%), and reporting of harms (27, 87%) (p < 0.05). While Indianjournals performed better on points like additional analyses (19, 63.3%) and recruitment dates (23, 76.6%). Overall, the international journal demonstrated significantly higher overall adherence to CONSORT guidelines compared to the Indian journal (p < 0.05). The international journal exhibited greater overall adherence than the Indian journal, with the difference being statistically significant (p < 0.05). The overall reporting was suboptimal. Adherence should be improved further, andthe journals should ensure the compliance of authors and reviewers with the standard reporting guidelines.

Influence of different print orientations on properties and behavior of additively manufactured resin dental devices: A systematic review and meta-analysis.

Influence of different print orientations on properties and behavior of additively manufactured resin dental devices: A systematic review and meta-analysis.

Effect of perioperative remote ischemic conditioning on myocardial injury in patients with unstable angina undergoing percutaneous coronary intervention: protocol of a multicenter, randomized, double-blind clinical trial

BackgroundCardiovascular disease is a leading cause of death, with ischemic heart disease being a significant contributor. While percutaneous coronary intervention (PCI) effectively reduces mortality in myocardial infarction patients, its efficacy for unstable angina (UA) patients is controversial. Complications associated with PCI further limit application in UA. RIC is hypothesized to be an effective co-intervention that reduces PCI-related complications and may potentially enhance the efficacy of the PCI procedure itself.MethodsThis is a pragmatic, prospective, dual-center, double-blind, randomized controlled clinical trial assessing the effect of remote ischemic conditioning (RIC) during percutaneous coronary intervention (PCI) on injury in unstable angina patients aged ≥ 18 years undergoing coronary angiography. Participants will be randomized to receive either RIC or Sham RIC, in addition to standard pharmacotherapy. Primary outcome includes periprocedural myocardial injury measured by hs-cTnT levels, while secondary outcomes encompass major adverse cardiovascular events, coronary artery lesions Gensini Score, arrhythmia, angina incidence, SAQ scores, ECG changes, and cardiac function assessed by two-dimensional echocardiography. The trial aims to recruit 574 participants and is scheduled to be initiated on 15 January 2024. We will conduct the primary statistical analysis using the intention-to-treat principle. Results from the trial will be presented as comparative summary statistics following the Consolidated Standards of Reporting Trials (CONSORT) guidelines.Trial registrationChiCTR2400079855, 15 January 2024.

Pilot randomized controlled trial of extracorporeal shock wave therapy for temporomandibular joint disorders.

Temporomandibular joint disorders (TMDs) are collective terms for a series of clinical diseases. However, due to the complexity of the temporomandibular joint (TMJ), TMDs are still unknown as to their pathogenesis. This pilot randomized controlled trial aimed to evaluate the efficacy of extracorporeal shock wave therapy (ESWT) in conjunction with drug therapy for myogenic TMDs. In accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines, we conducted a randomized controlled trial involving 60 patients diagnosed with myogenic TMDs. Patients with myogenic TMDs (Class I) were randomly divided into ESWT group and Ultrashort Wave (UW) group. The UW group was given ultrashort wave combined with drug therapy, while the ESWT group was given extracorporeal shock wave combined with drug therapy. The primary outcome was pain intensity measured by the Visual Analog Scale (VAS), and secondary outcomes included maximum mouth opening (MMO) and temporomandibular joint function indices. Post-treatment assessments revealed significant improvements in VAS scores and MMO in both groups (p < 0.05). Besides, compared with the UW group, the VAS score, the degree of MMO and Friction indexes of the TMDs patients in the ESWT group were remarkably improved after treatment (p < 0.05). For TMDs patients, extracorporeal shock wave combined with drug therapy can more quickly and effectively relieve the pain of the patient and improve the patient's dysfunction. However, due to the limitations of a small sample size and lack of prospective registration, these findings should be interpreted with caution. Future studies with larger sample sizes and proper registration are warranted.

Evaluating the Knowledge Level, Practice, and Behavioral Change Potential of Care Managers in Pressure Injury Prevention Using a Mobile App Prototyping Model in the Home-Care Setting: Single-Arm, Pre-Post Pilot Study.

The use of mobile apps to promote knowledge level, practice, and behavioral change potential has become increasingly common. However, studies on apps targeting social welfare employees working in the home-care setting to prevent pressure injury (PI) are lacking. The care manager (CM) plays a key role in connecting the demand and supply of home-care services. PI is more prevalent in the home-care setting, where resources are limited, than in acute settings. The research hypothesis was that CMs who use a mobile app will have improved general knowledge and heightened practice for PI prevention, compared to that before using the app. This study aimed to assess the effectiveness of a PI prevention support mobile app prototyping model (Pips-Map) in improving the knowledge level, practice, and behavioral change potential of CMs in PI prevention in the home-care setting. This was conducted between December 2021 and December 2023 as a single-arm, pre-post pilot study including 27 CMs who worked in a Japanese city. Pips-Map was used for 6 months in daily practice, and a self-administered test questionnaire was used to assess participants' knowledge and practice in PI prevention before or after using Pips-Map. At the end of the posttest, a validated App Behavior Change Scale was used to analyze behavioral change potential. This study followed the Consolidated Standards of Reporting Trials (CONSORT) extension to pilot and feasibility trials. In total, 19 participants were analyzed. Out of 55 points, the total mean knowledge score significantly increased from 30.9 (SD 5.9) in the pretest group to 36.1 (SD 5.9) in the posttest group (P=.0003). The number of participants with a total score of >70% (adequate knowledge level) increased from 2 (11%) to 7 (36.8%), but the difference was not statistically significant (P=.07). For the level of practice, out of 21 points, the total score increased from 15.2 (SD 3.1) in the pretest group to 16.2 (SD 3.0) in the posttest group, but no statistically significant differences were observed (P=.16). The behavior change scale revealed that participants positively evaluated the Pips-Map to provide information on PI prevention guidelines but had concerns regarding inadequate usability and financial incentives of Pips-Map. The use of Pips-Map for 6 months in actual practice increased the knowledge level of Japanese CMs in PI prevention, but it did not change the level of practice. Considering the need for updating apps that aim to promote behavioral change, this study identified some limitations of Pips-Map. Thus, revisions must be made to adapt Pips-Map to home-based care needs.

Impact of BRACTS exercises on muscular strength in eumenorrheic women

The sex steroid hormones significantly impact women’s physiology. Therefore, recently developed integrated exercises consisting of Bending, Roll-ups, Arm swings with loads, Crunches, Tandem walks, and Squats (BRACTS) were formulated. It was the exercise approach that required minimal equipment and was cost-effective and practical for implementation across a broad spectrum of women. So, this study aims to evaluate the effects of BRACTS exercises on strength during different phases of the menstrual cycle in eumenorrheic women. This is a two-armed parallel design, single-blinded, randomized controlled trial following Consolidated Standards of Reporting Trials (CONSORT) guidelines, and the study protocol is based on Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Participants were randomly allocated with a 1:1 ratio into Group A (control group) and Group B (treatment group). Group A was given an educational program related to menstrual hygiene and active lifestyle maintenance with 20 min walk 3 times a week for 16 weeks, while group B was given an educational program related to menstrual hygiene along with BRACTS exercises of 50 min for 3 times per week for 16 weeks. Assessments were done at baseline, midline, and end of the therapy using SPSS version 25. The experimental group demonstrated a notable improvement in muscular strength in follicular, mid-cycle, and luteal phases, with Cohen’s d values for left and right hand grip strength to be maximum in follicular phase while for left and right quadriceps, left and gastro-soleus showed maximum Cohen’s d value in mid-cycle phase of menstrual cycle. The mixed model ANOVA indicates statistically significant differences (p < 0.05) between the two groups, with influence from menstrual cycle phases. So, the BRACTS exercise protocol significantly improves muscular strength across different phases of the menstrual cycle in eumenorrheic women, demonstrating its efficacy as a cost-effective and practical approach. The trial was registered on clinicaltrials.gov for registration with ID: NCT05460741 on 05/31/2022 and was last released on 04/29/2024.Trial registration number: NCT05460741.

Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study

BackgroundExtensions to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting recommendations specifically for factorial trials have been developed by the Reporting Factorial...

A call for transparency, improved reporting, and interpretation of trials using surrogate end points in cardiac electrophysiology.

A call for transparency, improved reporting, and interpretation of trials using surrogate end points in cardiac electrophysiology.