Controlled Design Research Articles

Research on the Rehabilitation Effect of Repetitive Transcranial Magnetic Stimulation Combined with Cognitive Training on Children with Mental Retardation

This study investigated the rehabilitation effect of repetitive transcranial magnetic stimulation (rTMS) combined with cognitive training on children with mental retardation (MR). Through a randomized controlled trial design, 40 children aged 2–6 years with mental retardation were selected as study subjects and randomly divided into two groups: conventional treatment group and rTMS combined with cognitive training treatment group. The results showed that compared with the conventional treatment group, the rTMS combined with cognitive training treatment group exhibited more significant effects in improving children’s cognitive function, social adaptability, and quality of life. This study not only enriched the theoretical basis of rehabilitation treatment for children with mental retardation but also provided strong evidence support for clinical practice.

Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, parallel-group, open-label, randomized clinical trial (RESPECT2).

Lipid management based on cardiovascular risk level is the cornerstone of primary prevention of coronary artery disease (CAD), while the accuracy and adherence of traditional cardiovascular risk stratification have been questioned. Prevention strategies based on imaging screening for atherosclerotic plaques are found to be more objective and adherent in recent studies. This trial aims to investigate the role of coronary computed tomography angiography (CCTA) in guiding the primary prevention of CAD in a randomized controlled design. Approximately 3400 middle-aged asymptomatic community participants will be recruited and randomized in a 1:1 ratio to a traditional cardiovascular risk score-guided (usual care group) or CCTA-guided (CCTA group) strategy. Participants with cardiovascular disease, prior lipid-lowering therapy, CCTA contraindication, or serious diseases that affect life span will be excluded. The intervention strategy includes blood pressure, blood glucose, and lipid management and lifestyle modifications. Blood pressure and glucose targets and lifestyle modification recommendations keep the same in both strategies, while lipid management is personalized based on traditional risk level or CCTA results, respectively. The primary outcome is the proportion of participants taking lipid-lowering medication regularly at both 6 and 12months. The secondary outcomes include the proportion of participants achieving low-density lipoprotein cholesterol lowering targets at 12months, mean changes in lipid levels from baseline to 12months, barriers to adherence, adverse reactions related to CCTA examination, and cardiovascular events. The study is the first randomized clinical trial to examine the effectiveness of a CCTA-guided versus a traditional risk score-guided primary prevention strategy in an asymptomatic community-based population. ClinicalTrials.gov NCT05725096. Registered on 2 February 2023.

Study on the influence of ketogenic diet and intermittent fasting on the change of body fat rate

The purpose of this study is to explore the influence of ketogenic diet and intermittent fasting on the change of body fat rate, and to provide more scientific and effective methods for obese people to lose weight. Through randomized controlled trial design, 120 overweight or obese subjects were recruited and randomly divided into four groups for 12 weeks of dietary intervention. The control group kept their daily eating habits, while the ketogenic diet group adopted a diet scheme of high fat, low carbohydrate and moderate protein. The intermittent fasting group chose two days a week for light fasting, while the combined group used ketogenic diet and intermittent fasting at the same time. The research results show that both the ketogenic diet group and the intermittent fasting group can effectively reduce the weight and body fat percentage of the subjects, and the combination of the two has the most significant effect. The ketogenic diet group showed the greatest decrease in body weight and body fat percentage, at -3.5 ± 1.2kg and -4.8 ± 1.5%, respectively, while the combined group showed a more significant decrease, reaching -4.7 ± 1.4kg and -6.3 ± 1.8%, respectively. Regression analysis shows that ketogenic diet, intermittent fasting and their combination have significant effects on body fat rate, and the increase of weekly exercise time is also significantly related to the decrease of body fat rate. The study also found that ketogenic diet and intermittent fasting have their own advantages in reducing body fat rate, but they may also bring certain health risks, such as hypoglycemia and ketoacidosis. Therefore, doctors or nutritionists should tailor the diet plan according to individual conditions and pay attention to its potential side effects. This study provides a new weight loss option for obese people and provides a direction for future research.

Study protocol: process and outcome evaluation of the Walk with Ease program for fall prevention

BackgroundFalls are the leading cause of injury related morbidity and mortality in older adults. Primary and secondary prevention strategies that address modifiable risk factors are critically important to reduce the number of falls and fall related injuries. A number of evidence-based fall prevention programs are available, but few offer potential for broad dissemination and public health impact due to implementation barriers, such as a need for trained program leaders and clinicians.MethodsThe study will use a randomized controlled trial design to evaluate incorporating physical therapy exercises (primary prevention strategy) within an existing intervention called Walk with Ease. While Walk with Ease has an established evidence-base related to the management of arthritis pain and symptoms, the present study will determine the potential to also reduce falls and fall risk in community-dwelling older adults. The integrated process and outcome evaluation will determine the relative effectiveness of individually-prescribed exercises (compared to standardized exercises) as well as the potential of ‘habit training’ resources (relative to generic behavior prompts) to improve compliance with exercises in this population.DiscussionThe study, conducted through a local clinical-community partnership will advance both the science and practice of community-based fall prevention programming, while also informing implementation strategies needed to promote broader dissemination.Trial registrationClinicalTrials.gov, NCT05693025, Registered January 20, 2023, Updated March 1, 2023.

Exploration and Application of the Flipped Classroom Based on Outcome-Oriented Educational Principles in Vocational Nursing Practical Training

Purpose: To explore the practical effects of using the flipped classroom approach based on outcome-oriented educational concepts in nursing practical training at vocational colleges. Methods: From February 2023 to February 2024, a total of 62 nursing trainees from our school were sampled and randomly divided into a study group and a control group using a randomized controlled trial design, with 31 students in each group. The control group received conventional training, while the study group received practical training based on the outcome-oriented educational concept in flipped classrooms. Comparison was made between the two groups on assessment scores, teaching satisfaction, and self-directed learning ability ratings. Results: Statistical comparisons showed that the study group’s assessment scores, teaching satisfaction, and self-directed learning ability ratings were significantly higher than those of the control group (P < 0.05). Conclusion: The flipped classroom model based on outcome-oriented educational concepts in nursing practical training at vocational colleges can improve students’ assessment scores and self-directed learning abilities, and enhance teaching satisfaction, demonstrating potential for wider application and dissemination.

Acute Effects of High-intensity Circuit Training Using Body Weight on Body Composition Indices in Sedentary Collegiate Females

High-intensity circuit training (HICT) has become increasingly popular for enhancing health and fitness. However, limited research exists on the effects of high-intensity circuit training using body weight (HICTBW) on body composition in sedentary young adults. This study aimed to explore the impact of a 4-week HICTBW program on body composition in sedentary collegiate females. A randomized controlled trial design was employed. Twenty sedentary collegiate females were randomly assigned to either a training group (n=10), which participated in a 4-week HICTBW program, or a control group (n=10), which did not engage in any training. Body composition was assessed using bioelectrical impedance analysis (r = 0.642 to 0.78), measuring body fat percentage, fat mass, muscle mass, waist-to-hip ratio, and body mass index (BMI). Repeated measure ANOVA was used to compare between and within groups. Although no significant differences in body composition variables were observed between pre- and post-training (p>0.05), slight positive changes were noted in all measured parameters. The lack of significant findings may be attributed to the short duration and frequency of the intervention. Future studies with extended training periods are recommended to better understand the potential impact of HICTBW on body composition in sedentary collegiate females. This research highlights the need for more comprehensive studies to validate the effectiveness of HICTBW in improving body composition among this population.

Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price

ObjectiveThis study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval.MethodsWe identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed.ResultsThe median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062).ConclusionsOver the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life.

A Review of Studies on HIV Pre-Exposure Prophylaxis in Community Pharmacies in States with Restrictive Pharmacist Prescription Authority in the United States.

A systemic literature review was conducted to identify the primary literature that involved community pharmacy service and PrEP conducted in states that do not have expanded pharmacist prescriptive authority between 2000 to 2024. Ten publications were identified, describing nine studies, including four interview and survey studies, three intervention reports, and two ongoing clinical trials. None of these studies have a control group. Most pharmacists provide PrEP services in the community through a collaborative practice agreement with a primary care provider. Future clinical studies with randomized controlled designs are required to test novel strategies in the education and implementation of pharmacy-led PrEP services in a community pharmacy setting to increase PrEP access.

Resistance exercise snacks as a workplace health intervention

Introduction & Purpose Although resistance training (RT) is essential to preserve musculoskeletal fitness and maintain a healthy, independent life into old age, only 10-30% of adults perform the recommended number of 2 RT per week, with women participating in even less RT (Bennie et al., 2016, 2018). As women have less skeletal muscle mass, experience an earlier strength loss, and a greater decline in muscle quality, RT appears especially beneficial for them (Doherty, 2001; Janssen et al., 2000). A novel approach to deal with common participation barriers (lack of time, limited access to equipment/facilities) are resistance exercise snacks (RES; Fyfe et al., 2022). Therefore, it was investigated whether RES is an efficient concept for the workplace health promotion (WHP) to facilitate RT in women and improve musculoskeletal fitness. Methods This pilot-study followed a prospective, controlled intervention design. Female employees with sedentary occupations doing RT on less than 2 days/week before study participation were included. Participants self-selected for intervention group (IG) or control group (CG). While the IG (N = 15, mean age 42.1 ± 11.1 years) completed 10 min of RES each working day for 12 weeks supervised by a trainer, the CG (N = 15, mean age 49.9 ± 9.7 years) maintained their habitual physical activity. Primary outcome was change in muscle mass (bioelectrical impedance analysis, SECA® mBCA515 scale). Secondary outcome was change in maximum isometric strength (Dr. WOLFF BackCheck® 617). Balance (Y-balance composite-score, Y-Balance test kit), cardiovascular fitness, (6-minute walking test), perceived health (minimum European health module), and general life satisfaction (general life satisfaction short scale) were assessed for exploratory purpose. Measurements were taken before and after the intervention. The difference in change between groups for muscle mass, strength, balance, and cardiovascular fitness was analyzed via mixed model ANOVA. For perceived health and general life satisfaction Wilcoxon test was applied to analyze within group changes. Results 12 participants of IG and 14 of CG completed the study. Muscle mass improved significantly more in the IG (+.42 kg ± .54) compared to the CG (-.16 kg ± .51) (p = .01, ⴄ²p = .24). Strength did not change significantly between groups. Nevertheless, there was a trend for greater improvements in the IG compared to the CG for trunk extension, trunk flexion, and upper body push but not upper body pull. Regarding exploratory endpoints, no significant changes were found. Discussion Findings of the present study support the notion that training with light loads (< 30% of 1RM) effectively stimulate muscle protein synthesis if the intensity of effort is high. Higher training loads might be required to maximally recruit muscle fibers and induce optimal strength gains. For improvements in balance and cardiovascular fitness more specific training programs are required. Future studies should investigate what training stimuli are needed within RES (e.g., volume, load, frequency) to optimize improvements in musculoskeletal fitness and motivate participants in the long-term applying randomized controlled intervention designs. Conclusion RES is an efficient approach for the WHP to improve muscle mass in inactive women with sedentary occupations. References Bennie, J. A., Lee, D.-C., Khan, A., Wiesner, G. H., Bauman, A. E., Stamatakis, E., & Biddle, S. J. H. (2018). Muscle-strengthening exercise among 397,423 U.S. adults: Prevalence, correlates, and associations with health conditions. American Journal of Preventive Medicine, 55(6), 864–874. https://doi.org/10.1016/j.amepre.2018.07.022 Bennie, J. A., Pedisic, Z., van Uffelen, J. G. Z., Charity, M. J., Harvey, J. T., Banting, L. K., Vergeer, I., Biddle, S. J. H., & Eime, R. M. (2016). Pumping iron in Australia: Prevalence, trends and sociodemographic correlates of muscle strengthening activity participation from a national sample of 195,926 adults. PLoS ONE, 11(4), Article e0153225. https://doi.org/10.1371/journal.pone.0153225 Doherty, T. J. (2001). The influence of aging and sex on skeletal muscle mass and strength. Current Opinion in Clinical Nutrition & Metabolic Care, 4(6), 503–508. Fyfe, J. J., Hamilton, D. L., & Daly, R. M. (2022). Minimal-dose resistance training for improving muscle mass, strength, and function: A narrative review of current evidence and practical considerations. Sports Medicine, 52(3), 463–479. https://doi.org/10.1007/s40279-021-01605-8 Janssen, I., Heymsfield, S. B., Wang, Z., & Ross, R. (2000). Skeletal muscle mass and distribution in 468 men and women aged 18–88 yr. Journal of Applied Physiology, 89(1), 81–88. https://doi.org/10.1152/jappl.2000.89.1.81

Controllable Design of Polyamide Composite Membrane Separation Layer Structures via Metal-Organic Frameworks: A Review.

Optimizing the structure of the polyamide (PA) layer to improve the separation performance of PA thin-film composite (TFC) membranes has always been a hot topic in the field of membrane preparation. As novel crystalline materials with high porosity, multi-functional groups, and good compatibility with membrane substrate, metal-organic frameworks (MOFs) have been introduced in the past decade for the modification of the PA structure in order to break through the separation trade-off between permeability and selectivity. This review begins by summarizing the recent progress in the control of MOF-based thin-film nanocomposite (TFN) membrane structures. The review also covers different strategies used for preparing TFN membranes. Additionally, it discusses the mechanisms behind how these strategies regulate the structure and properties of PA. Finally, the design of a competent MOF material that is suitable to reach the requirements for the fabrication of TFN membranes is also discussed. The aim of this paper is to provide key insights into the precise control of TFN-PA structures based on MOFs.

Testing the Effectiveness of a Mobile Smartphone App Designed to Improve the Mental Health of Junior Physicians: Protocol for a Randomized Controlled Trial.

Shift (Black Dog Institute) is the first mobile health smartphone appcreated to support the mental health of junior physicians. Junior physicians experience demanding work conditions, leading to high levels of psychological distress and burnout. However, they are often concerned about the potential career impacts of seeking mental health support. The confidentiality and ease of access of digital interventions may be particularly suited to address these concerns. The Shift app provides therapeutic and psychoeducational content and strategies contextualized for the specific needs of physicians in training. App content includes information on mental health, help seeking, mindfulness, and common workplace-related concerns of junior physicians. This study aims to test, at scale, the effectiveness of Shift among junior physicians working in Australia using a randomized controlled trial design. The primary aim is to examine whether junior physicians using Shift experience a reduction in depressive symptoms compared with a waitlist control group. The secondary aim is to examine whether the app intervention group experiences improvements in anxiety, work and social functioning, help seeking, quality of life, and burnout compared with the control group. A total of 778 junior physicians were recruited over the internet through government and nongovernment medical organizations across Australia, as well as through paid social media advertisements. They were randomly allocated to one of 2 groups: (1) the intervention group, who were asked to use the Shift app for a period of 30 days, or(2) the waitlist control group, who were placed on a waitlist and were asked to use the app after 3 months.Participants completed psychometric measures for self-assessing mental health and wellbeing outcomes, with assessments occurring at baseline, 1 month after completing the baseline period, and 3 months after completing the baseline period. Participants in the waitlist control group were asked to complete an additional web-based questionnaire 1 month after receiving access to the app or 4 months after completing the baseline survey. Participants took part in the study on the internet; the study was completely automated. The study was funded from November 2022 to December 2024 by the New South Wales Ministry of Health. Data collection for the study occurred between January and August 2024, with 780 participants enrolling in the study during this time. Data analysis is underway; the effectiveness of the intervention will be estimated on an intention-to-treat basis using a mixed-model, repeated measures analysis. Results are expected to be submitted for publication in 2025. To the best of our knowledge, this is the first randomized controlled trial to examine the effectiveness of a mobile health smartphone app specifically designed to support the mental health of junior physicians. Australia and New Zealand Clinical Trials Registry ACTRN12623000664640; https://tinyurl.com/7xt24dhk. DERR1-10.2196/58288.

Development of a Generative Design System for 3D-Printed Houses in Chile

Three dimensional-printing construction is an emerging technology with significant potential for faster building execution and more precise, controllable designs. This technology utilizes material deposition managed by computer data, enabling additive construction of shapes. This research aims to develop a generative design system for 3D-printed houses in Chile, addressing the country’s growing demand for housing across diverse geographical locations and social groups, also present in other parts of the world. The development process involves synthesizing the external form features of existing Chilean houses and analyzing prototypes of 3D-printed houses worldwide to establish a set of geometric characteristics suitable for 3D-printed homes in Chile. A procedure is then outlined to create design alternatives using parametric programming on a BIM platform, followed by toolpath development for printing the building components. Various models are generated to demonstrate housing shapes’ versatility and adaptability to Chilean contexts and 3D-printed construction methods. Finally, a detailed design is created and printed to construct a housing prototype, testing the entire digital workflow. This experience highlights the variety of 3D-printed housing shapes that can be developed while assessing their feasibility for the Chilean context. This research complements the flexible design capabilities of 3D printing construction, resulting in buildings better suited to various locations and occupancy needs.

Remote electrical neuromodulation to treat children and adolescents with migraine in the emergency department: Arandomized double-dummy pilot trial.

Using a double-dummy pilot randomized controlled trial design, we aimed to determine the feasibility and acceptability of comparing remote electrical neuromodulation (REN) to typical care intravenous pharmacologic interventions for the treatment of children and adolescents visiting the emergency department (ED) with migraine, and to compare parallel-group versus crossover trial designs. There are limited data to guide the management of migraine in the ED. Children and adolescents are interested in neuromodulation, and specifically REN, for treatment in this setting, but there are no existing data on this approach. We employed a double-dummy, double-blind, pilot randomized controlled trial that tested two designs in two phases: a parallel-group design and a crossover design (ClinicalTrials.gov identifier: NCT05102591). The intervention arms consisted of: (i) active REN stimulation with matched normal saline placebo intravenously, and (ii) matched sham REN stimulation, intravenous metoclopramide (0.15 mg/kg, maximum 10 mg), and intravenous ketorolac (0.5 mg/kg, maximum 30 mg). Youth aged 8.0-<18.0 years visiting a Canadian tertiary care pediatric ED with migraine attacks as per criteria B-E of the International Classification of Headache Disorders third edition were eligible. Primary outcomes were focused on trial feasibility and acceptability, and preliminary efficacy and safety data were also collected. A total of 34% (22/65) of those who screened eligible were enrolled. Three participants (14%) withdrew prior to receiving any study interventions. In all, 10 participants were allocated to typical care, and nine to REN. All treated participants (19/19) completed all assessments. Recruitment was higher during the parallel-group phase: 1.1 participants/month versus 0.6 participants/month, and 36% (17/47) versus 28% (five of 18) of screened eligible were enrolled in the parallel-group and crossover phases, respectively. Participants reported positive impressions of REN use in the ED, e.g., higher mean (standard deviation [SD]) levels of interest in using REN only at 3.7 (1.0) versus 2.8 (1.0) in using intravenous interventions only for a future ED visit. Participants and clinical staff reported overall positive impressions regarding the study protocol. Employing an 11-point pain numerical rating scale, the mean (SD) reduction in pain severity score was 2.1 (1.3) and 2.9 (2.9) from baseline to 1 h, and 2.4 (1.6) and 4.0 (3.5) from baseline to 2 h for REN and intravenous interventions, respectively. One participant in the typical care group and none in the REN group experienced adverse events. We demonstrated the feasibility and acceptability of our trial protocol and of using REN to treat youth presenting to the ED with migraine. The parallel-group design generated a higher recruitment rate than the crossover design. Our preliminary efficacy and safety data suggest that REN could be non-inferior to typical care, but we were not powered for these outcomes. Further research on REN's use in the ED setting is warranted.

Rational design of a room‐temperature curing method, based on the epoxy–thiol click reaction, for UV‐curable hard coatings with ultrahigh strength and adhesion

AbstractIn recent years, there has been a growing demand for UV‐curable hard coatings because they offer several advantages, for example, lower energy consumption and the absence of volatile organic compound emissions. Anionic UV curing with photobase generators (PBGs), such as epoxy–thiol cross‐linking, enables curing under ambient conditions. However, designing a room‐temperature photoanionic curing system for epoxy–thiols remains challenging due to the complex effects of resin combinations on the cured products, thus making it difficult to prepare films with high hardness. Herein, we present a controlled reaction design for an anionic UV‐curing system by combining the chemical structures of epoxy resins and multifunctional thiols. The anionic UV‐curing system using PBGs that generate organic superbases demonstrated UV‐delayed curability, as evidenced by FT‐IR and photorheological analyses. To achieve high hardness, it was necessary to create the thiols with ultrarigid structures; epoxy resins with a bisphenol F structure were optimal for reacting with thiols for ultrarigid structures. This combination afforded an indentation hardness of 262 MPa with an epoxy conversion rate of 77% even at room temperature.

Estimation of efficacy of a home monitoring and communication platform to prevent frailty among older adults in Sweden- a pilot study with a randomized controlled trial design

BackgroundThe aging population of the world is increasing. Aging leads to risks for frailty and other chronic diseases and health systems must focus more on prevention to guarantee healthy aging. The primary objective was to estimate the efficacy of the POSITIVE-(The Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs) system in improving frailty during a 6-month follow-up period. MethodA randomized controlled, assessor-blinded pilot study (RCT) with 50 individual < 70 years, pre-frail or frail was recruited from a primary care center in Stockholm Region. All participants received a drug review, nutritional recommendations, and a Vivifrail physical exercise program. In addition, the intervention group received POSITIVE including a tablet, an application, and portable measurement devices. The intervention group was monitored remotely by a primary care nurse at the primary health care centre during a six-month follow-up period. ResultsAt baseline there was a significance between the groups regarding the FTS-5 scale, and significantly more obese participants in the intervention group. The drug reviews showed that three of 43 participants got a review and new diseases were discovered. The test of interactions showed a tendency for significant differences over time between the groups in frailty measured by Fried Frailty Phenotype's and FTS-5 scales. ConclusionFrailty status over time in the intervention group not differed significantly from the controls. Including individuals to the project even through a pandemic showing that the design is possible for future studies to show effects of new ways of preventing frailty at home. Trial RegistrationClinicalTrials.gov. Registration number: NCT04592146. October 19, 2020. https://clinicaltrials.gov/ct2/show/NCT04592146?term=positive&draw=2&rank=7

Psychological Health and Wellness and the Impact of a Supportive Text Messaging Program (Wellness4MDs) Among Physicians and Medical Learners in Canada: Protocol for a Longitudinal Study.

Burnout, anxiety, and depression continue to affect physicians, postgraduate medical trainees, and medical students globally and in Canada particularly after the COVID-19 pandemic. The primary goal of this project is to design, implement, monitor, and evaluate a daily supportive SMS text messaging program (Wellness4MDs, Global Psychological e-Health Foundation). The program aims to reduce the prevalence and severity of burnout, anxiety, and depression symptoms among physicians, postgraduate medical trainees, and medical students in Canada. This longitudinal study represents a multistakeholder, mixed methods, multiyear implementation science project. Project evaluation will be conducted through a quantitative prospective longitudinal approach using a paired sample comparison, a naturalistic cross-sectional controlled design, and satisfaction surveys. Prevalence estimates for psychological problems would be based on baseline data from self-completed validated rating scales. Additional data will be collected at designated time points for paired comparison. Outcome measures will be assessed using standardized rating scales, including the Maslach Burnout Inventory for burnout symptoms, the 9-item Patient Health Questionnaire for depression symptoms, the 7-item Generalized Anxiety Disorder scale for anxiety symptoms, and the World Health Organization-Five Well-Being Index. The project launched in the last quarter of 2023, and program evaluation results will become available within 36 months. The Wellness4MDs program is expected to reduce the prevalence and severity of psychological problems among physicians in Canada and achieve high subscriber satisfaction. The results from the Wellness4MDs project evaluation will provide key information regarding the effectiveness of daily supportive SMS text messages and links to mental health resources on these mental health parameters in Canadian physicians, postgraduate trainees, and medical students. Information will be useful for informing policy and decision-making concerning psychological interventions for physicians in Canada. PRR1-10.2196/44368.

Active versus passive foam rolling on range of motion, tissue property, and neural adaptation in healthy young adults: A randomised controlled trial

IntroductionSelf-massage using a foam roller (foam rolling) is effective for increasing range of motion (ROM). However, the independent effects of pressure stimulation and voluntary movement during foam rolling remain unclear. This study investigated the effects of pressure stimulation and voluntary movement during the foam rolling intervention on ROM and its related parameters from the aspects of tissue mechanical properties and the central nervous system. MethodsThis study set a randomised open-label controlled parallel group design involving active foam rolling with pressure stimulation and voluntary movement (A-FR), passive foam rolling with only pressure stimulation (P-FR), and sham rolling with only voluntary movement (SHAM) of the calf muscle. Twenty-seven healthy active adults (males: 16, females: 11) were analysed. Parameters of tissue mechanical properties (as measured by tissue stiffness and thickness) and systemic nervous adaptation (as measured by PPT, stretch tolerance, HRV, and mood states), as well as maximal ankle active/passive dorsiflexion ROM, were measured. ResultsA-FR significantly improved pressure pain threshold, stretch tolerance, and negative mood and increased active and passive ROM. P-FR significantly improved parasympathetic nervous activity and negative mood and increased passive ROM. However, SHAM did not affect any ROM or parameters of tissue mechanical properties and systemic neural adaptation except for some negative mood improvement. ConclusionVoluntary movement does not independently affect ROM, whereas pressure simulation independently enhances ROM during the foam rolling intervention. Combining pressure stimulation and voluntary movement can enhance the ROM effect and influence parameters of tissue mechanical properties and the central nervous system.

The effect of education provided with the escape room game on nursing students' learning of parenteral drug administration

AimThe present study was conducted to determine the effect of education provided to first-year nursing students with the escape room game on their learning of parenteral drug administration. BackgroundThe use of escape room games in education supports formal education in providing students with professional knowledge and skills. DesignA randomized controlled study design was used in this study. MethodThe current study was conducted with 72 first-year nursing students. Data were collected with the Descriptive Characteristics Questionnaire (DCQ), Parenteral Drug Administration Information Test (PDAIT), Parenteral Drug Administration Sub-Checklists (PDASC) and Game Evaluation Form (GEF) between May and June 2022. The initial knowledge and skills of all students participating in the study were measured after completing the parenteral drug administration theoretical course and laboratory skills course. Students were assigned to the intervention (n=36) and control (n=36) groups by the stratified block randomization method according to their initial knowledge and skill measurements. Unlike the control group, the intervention group played the escape room game once in groups of four. The control group was allowed to work freely in the laboratory during this period. The final knowledge and skills of the intervention and control groups were measured immediately after the intervention. Students' skills were measured with an objective structured clinical examination. ResultsIt was determined that the post-test knowledge level of the students in the intervention group and their post-test skill mean scores for drug withdrawal from an ampoule, subcutaneous injection administration, intradermal injection administration and intravenous push drug administration were higher than those of the students in the control group (p<0.05). Additionally, Intervention group students evaluated the escape room game positively. ConclusionThis study concluded that the escape room game supported formal education and could be used in teaching parenteral drug administration.

Effects of Virtual Reality Motor-Cognitive Training for Older People With Cognitive Frailty: Multicentered Randomized Controlled Trial.

Cognitive frailty refers to a clinical syndrome in which physical frailty and mild cognitive impairment coexist. Motor-cognitive training and virtual reality (VR) have been used to launch various therapeutic modalities to promote health in older people. The literature advocates that motor-cognitive training and VR are effective in promoting the cognitive and physical function of older people. However, the effects on older people with cognitive frailty are unclear. This study examined the effects of VR motor-cognitive training (VRMCT) on global cognitive function, physical frailty, walking speed, visual short-term memory, inhibition of cognitive interference, and executive function in older people with cognitive frailty. This study used a multicentered, assessor-blinded, 2-parallel-group randomized controlled trial design. Participants were recruited face-to-face in 8 older adult community centers. Eligible participants were aged ≥60 years, were community dwelling, lived with cognitive frailty, had no dementia, and were not mobility restricted. In the intervention group, participants received VRMCT led by interventionists with 16 one-hour training sessions delivered twice per week for 8 weeks. In the control group, participants received the usual care provided by the older adult community centers that the investigators did not interfere with. The primary outcome was global cognitive function. The secondary outcomes included physical frailty, walking speed, verbal short-term memory, inhibition of cognitive interference, and executive function. Data were collected at baseline (T0) and the week after the intervention (T1). Generalized estimating equations were used to examine the group, time, and interaction (time × group) effects on the outcomes. In total, 293 eligible participants enrolled in the study. The mean age of the participants was 74.5 (SD 6.8) years. Most participants were female (229/293, 78.2%), had completed primary education (152/293, 52.1%), were married (167/293, 57.2%), lived with friends (127/293, 43.3%), and had no VR experience (232/293, 79.5%). In the intervention group, 81.6% (119/146) of participants attended >80% (13/16, 81%) of the total number of sessions. A negligible number of participants experienced VR sickness symptoms (1/146, 0.7% to 5/146, 3%). VRMCT was effective in promoting global cognitive function (interaction effect: P=.03), marginally promoting executive function (interaction effect: P=.07), and reducing frailty (interaction effect: P=.03). The effects were not statistically significant on other outcomes. VRMCT is effective in promoting cognitive functions and reducing physical frailty and is well tolerated and accepted by older people with cognitive frailty, as evidenced by its high attendance rate and negligible VR sickness symptoms. Further studies should examine the efficacy of the intervention components (eg, VR vs non-VR or dual task vs single task) on health outcomes, the effect of using technology on intervention adherence, and the long-term effects of the intervention on older people with cognitive frailty at the level of daily living. ClinicalTrials.gov NCT04730817; https://clinicaltrials.gov/study/NCT04730817.

Three-Dimensional Printing Technology Based on Digital Orthopedics: 5-Point Positioning Point-Contact Pedicle Navigation Template in the Case of Scoliosis and Complex Pedicle.

Imperfect fitting of the navigation template leads to prolonged surgery time and increased blood loss. These problems have not been effectively addressed in previous research. This study explores the efficacy of a novel 5-point positioning point-contact pedicle navigation template in complex pedicle situations in scoliosis. This study employed a retrospective controlled design. From November 2019 to November 2023, 28 patients with scoliosis and complex pedicle were selected and underwent scoliosis correction surgery. A 5-point positioning point-contact pedicle navigation template was used intraoperatively to guide pedicle screw placement. Matched with 56 historical cases as a control group. The analysis included screw placement time, screw placement bleeding volume, fluoroscopy frequency, manual repositioning frequency, screw placement accuracy and grade, screw placement complications, and main curve correction rate. Continuous variables were compared using the independent samples t-test. Categorical data were analyzed with the chi-square test. All 28 patients successfully underwent surgery, with a total of 268 pedicle screws placed. The surgery duration ranged from 220 to 410 min, with an average of (283.16 ± 51.26) min. Intraoperative blood loss ranged from 630 to 1900 mL, with an average of (902.17 ± 361.25) mL. Pedicle screw placement time ranged from 60 to 130 min, with an average of (85.24 ± 24.65) min. Pedicle screw placement bleeding volume ranged from 40 to 180 mL, with an average of (76.47 ± 42.65) mL. Fluoroscopy frequency ranged from 3 to 7 times, with an average of (4.31 ± 1.14) times. Manual repositioning frequency ranged from 0 to 2 times, with an average of (0.46 ± 0.58) times. Pedicle screw placement grades: Grade I: 237 screws; Grade II: 25 screws; Grade III: 6 screws; Grade IV: 0 screws. There were no screw-related complications. The correction rate ranged from 46% to 68%, with an average of (55.83 ± 9.22)%. Compared to the experienced screw group, the differences in screw placement time, screw placement bleeding volume, fluoroscopy procedures, and manual redirections were statistically significant (p < 0.05). The 5-point positioning point-contact pedicle navigation template features a claw-like structure that securely adapts to various deformed vertebral facet joints, avoiding drift phenomena and ensuring accurate screw placement. Its pointed contact structure with the lamina of the spine avoids extensive and complete detachment of posterior structures, reducing blood loss, surgery time, and trauma. Predesigned pedicle screw entry points and directions reduce fluoroscopy frequency and surgery time.