Trial Study Research Articles

Risk of Nephrolithiasis Associated With SGLT2 Inhibitors Versus DPP4 Inhibitors Among Patients With Type 2 Diabetes: A Target Trial Emulation Study.

We aim to compare the risk of nephrolithiasis among type 2 diabetes patients who initiated sodium-glucose cotransporter-2 inhibitors (SGLT2is) versus dipeptidyl-peptidase-4 inhibitors (DPP4is), individually within stone never- and ever-formers. Using the 2010-2021 Korea National Health Insurance Service database, we conducted a population-based cohort study, comparing initiators of SGLT2is versus DPP4is. The primary outcome was incident nephrolithiasis. Osteoarthritis encounters served as a negative control outcome. After 1:1 propensity score (PS) matching in stone never- and ever-formers, pooled and individual hazard ratios (HRs), incidence rate difference (IRD), and 95% CIs were reported. Subgroup analyses by sex, age, thiazide co-use, and baseline cardiovascular risk were done. The 17,006 PS-matched pairs of SGLT2i and DPP4i initiators were pooled from stone never- (105,378 pairs) and ever-formers (11,628 pairs). Over a mean of 654 days, the risk of nephrolithiasis was lower in SGLT2i initiators than in DPP4i: 0.65 vs. 1.12 events per 100 person-years, HR 0.54 (95% CI, 0.50-0.57), IRD -0.46 (95% CI,-0.21 to -0.52). Among never-formers, the HR was 0.43 (95% CI, 0.39-0.48) and IRD was -0.32 (95% CI,-0.27 to -0.36). Among ever-formers, the HR was 0.64 (95% CI, 0.59-0.69) and IRD was -2.26 (95% CI,-1.77 to -2.76). Near-null associations were found for osteoarthritis encounters. Results were consistent across subgroups. We found a lower risk of nephrolithiasis associated with SGLT2is versus DPP4is in stone never- and ever-formers. Despite a greater relative risk reduction in the former, the absolute risk reduction was greater in the latter.

Dietary fat quality indices and risk of pre-diabetes and type 2 diabetes mellitus: Tehran Lipid and Glucose Study.

To assess associations between dietary fat quality indices (FQI) and risk of pre-diabetes and type 2 diabetes mellitus (T2DM) among Iranian adults. Daily intakes of fatty acids were estimated using a validated food frequency questionnaire with 168 food item. Adjusted hazard Ratios (HRs) and 95% confidence intervals (CIs) of pre-diabetes and T2DM were calculated in tertile categories of dietary FQI including atherogenic index (AI), thrombogenic index (TI), health promoting index (HPI), ratio of poly-unsaturated fatty acids to saturated fatty acids (PUFA/SFA) and ratio of hypo and hypercholesterolemia (h/H). Tehran Lipid and Glucose Study. Iranian men and women. Mean (±SD) age of the 2042 pre-diabetes-free participants in pre-diabetes analysis was 38.84 (12.97), and 55.2% were women. In T2DM analysis, mean (±SD) age of the 2295 T2DM-free participants was 40.06 (13.42), and 54.6% of them were women. In the crude model, PUFA/SFA ratio was positively associated with T2DM incidence (HR=1.43, 95% CI: 1.04-1.98). However, after adjustment for confounding variables, there were no significant associations between dietary FQI and risk of pre-diabetes and T2DM. We found no significant association between FQI and risk of pre-diabetes and T2DM. Further prospective and clinical trial studies are needed to clarify the issue.

Comparison Effect of Clonidine and Magnesium Sulfate on Bleeding Volume during Septorhinoplasty: A Double-Blind, Randomized Clinical Trial

Background: Control of hemodynamic changes and blood loss is a daily challenge in general anesthesia for patients undergoing septorhinoplasty. This study aimed to evaluate the effects of magnesium sulfate and clonidine on the control of hemodynamic factors and bleeding volume during this procedure. Methods: This double-blind, randomized clinical trial study was conducted on 60 patients undergoing septorhinoplasty at 5th Azar Medical & Educational Centre of Gorgan in 2021-2022. Patients were divided into two intervention groups (50 mg/kg of magnesium sulfate) and control group (5 μg/kg of clonidine) with permutation random block allocation. All patients underwent induced hypotension. Before induction of anesthesia and every 5 minutes afterwards, blood pressure was recorded. Blood loss volume was calculated at the end of the surgery. Results: In the magnesium group, 36 individuals were evaluated, while in the clonidine group, 24 individuals were examined. There were no statistically significant differences in baseline characteristics of patients in the two groups and the duration of surgery. Both drugs were equally effective in inducing hypotension, however blood pressure changes in magnesium group were more trivial than clonidine group. The bleeding volume in the magnesium sulfate and clonidine groups was 139.44 ml and 141.25, respectively and this difference was not statistically significant (p-value=0.634). Conclusion: The results of this study showed that magnesium sulfate can be effectively used as an alternative to clonidine in controlling hemodynamic changes and ultimately reducing blood loss volume during septorhinoplasty surgery. In addition, magnesium is at least as effective as clonidine in stabilizing hemodynamic changes.

Research and Experiments on Adaptive Root Cutting Using a Garlic Harvester Based on a Convolutional Neural Network

Aimed at the problems of a high leakage rate, a high cutting injury rate, and uneven root cutting in the existing combined garlic harvesting and root-cutting technology, we researched the key technologies used in a garlic harvester for adaptive root cutting based on machine vision. Firstly, research was carried out on the conveyor alignment and assembly of the garlic harvester to realize the adjustment of the garlic plant position and the alignment of the bulb’s upper surface before the roots were cut, to establish the parameter equations and to modify the structure of the conveyor to form the adaptive garlic root-cutting system. Then, a root-cutting test using the double-knife disk-type cutting device was carried out to examine the root-cutting ability of the cutting device. Finally, a bulb detector trained with the IRM-YOLO model was deployed on the Jetson Nano device (NVIDIA, Jetson Nano(4GB), Santa Clara, CA, USA) to conduct a harvester field trial study. The pass rate for the root cutting was 82.8%, and the cutting injury rate was 2.7%, which tested the root cutting performance of the adaptive root cutting system and its field environment adaptability, providing a reference for research into combined garlic harvesting technology.

The effect of computer-based Stress Inoculation Training (SIT) approach on the pelvic pain, depression, and anxiety in students with primary dysmenorrhea: a clinical trial study

BackgroundPrimary dysmenorrhea (PD) is one of the most common pains experienced by women. Stress Inoculation Training (SIT) is a cognitive-behavioral technique that immunizes them against future periods of stress. The purpose of this research is to investigate the effectiveness of a computer-based stress inoculation approach on pelvic pain, depression, and anxiety symptoms in students with PD.MethodsThe present study is a clinical trial conducted on 100 students with PD. The SIT intervention consisted of eight consecutive sessions. The content of the sessions was created as multimedia on a computer platform of a site. In each session, several interactive questions were asked about the topics of that session, and participants answered them, with responses recorded in the system. Then, each individual session, lasting about 50 min, was sent as a link (offline) to a participant. Data collection tools included the demographics Checklist, McGill Pain Questionnaire (MPQ), Moos Menstrual Distress Questionnaire (MMDQ), Hospital Anxiety and Depression Scale (HADS), Pain Self-Efficacy Questionnaire (PSEQ), and Perceived Stress Scale (PSS-14), which were completed on the second menstrual day of the cycle before the study and for three consecutive cycles after the intervention by each student. The data were analyzed using chi-square, generalized linear mixed models (GLMM), and multiple linear regression tests. The significance level was set at P < 0.05.ResultsThe results of the GLMM test showed that the SIT intervention decreased depression (p = 0.002), anxiety (p = 0.001), menstrual distress (p = 0.001), pain intensity (p = 0.003), and perceived stress (p = 0.002), while it increased pain self-efficacy (p = 0.001). Based on multiple linear regression analysis, the main predictors of depression were the student’s age and residence in a dormitory (β=-0.255, p = 0.047 and β=-0.376, p = 0.005, respectively). The factors influencing pain self-efficacy were birth rank and the type of university admission (β=-0.351, p = 0.027 and β=-0.249, p = 0.030, respectively). In the presence of confounding variables, increasing age and living in a dormitory were risk factors that increased depression, while studying with tuition fees and a higher birth rank were associated with decreased self-efficacy.ConclusionThe computer-based SIT was effective in reducing pelvic pain, and psychological factors, and in increasing pain self-efficacy in students with primary dysmenorrhea. Therefore, it can be used as a useful solution to manage complications associated with primary dysmenorrhea.Trial registrationIRCT20230130057274N5Date of registration: 2024-04-29Retrospectively registered

Investigating the effect of the educational intervention based on the Health Belief Model on the knowledge and beliefs of Yemeni teachers in the use of breast cancer screening: a randomized controlled trial study

BackgroundBreast cancer (BC) is the most prevalent cancer among women. Teachers play a crucial role in promoting healthy behaviors, including breast cancer screening (BCS). This study aimed to assess the impact of an Health Belief Model (HBM)-based educational intervention on BCS uptake, knowledge, and beliefs among female Yemeni teachers in Klang Valley, Malaysia.MethodsA cluster-randomized controlled trial was conducted with 180 participants from 12 schools, randomly assigned to intervention or control groups. The intervention group participated in a 90-minute educational session, with follow-up assessments at baseline, and at 1, 3, and 6 months’ post-intervention, using validated Arabic questionnaires. Data analysis was performed using SPSS version 22.0, with Generalized Estimating Equations (GEE) applied to assess differences within and between groups over time. Statistical significance was set at P < 0.05.ResultsAt baseline, there were no significant differences between groups. Post-intervention, the intervention group showed significantly higher rates of breast self-examination (BSE) and clinical breast examination (CBE) compared to the control group, with adjusted odds ratios (AOR) of 17.51 (CI: 8.22–37.29) for BSE and 2.75 (CI: 1.42–5.32) for CBE. Over six months, BSE performance in the intervention group increased, with AORs improving from 11.01 (CI: 5.05–24.04) to 18.55 (CI: 8.83–38.99). Similarly, CBE uptake rose from 1.60 (CI: 1.02–2.52) to 2.27 (CI: 1.44–3.58). Secondary outcomes revealed significant gains in knowledge and beliefs in the intervention group, including increased confidence in performing BSE and reduced perceived barriers.ConclusionsThe HBM-based educational intervention effectively enhanced BCS uptake, improved knowledge, and decreased barriers to BCS among Yemeni teachers in Malaysia, highlighting the potential of targeted educational programs to promote cancer screening behaviors in underserved populations.Clinical trial registrationRetrospectively registered, ANZCTR (ACTRN12618000173291). Registered on February 02, 2018.

Investigating the Effect of Bromelain Capsules on Stress, Anxiety and Depression in Patients with Diabetic Foot Ulcers

Depression and stress are common among individuals with diabetic foot ulcers. The purpose of this study was to find whether bromelain can alleviate these symptoms. This single blind, two-group clinical trial study was conducted in 2023. Eighty people with diabetic foot ulcers in specialised wound clinics of Tehran University of Medical Sciences were selected and randomly assigned to the test and control groups. The test group received capsules containing 500mg of bromelain twice a day for four weeks, and the control group received the same amount and number of placebos. After the intervention, the DASS-21 was completed again by the participants. The mean scores of depression, anxiety and stress of people with diabetic foot ulcers in the test group before taking bromelain were 16.02 ± 1.44, 11.62 ± 1.25 and 13.65 ± 1.81 respectively. After the intervention, they were 10.45 ± 1.44, 7.25 ± 1.17 and 10.80 ±1.72 respectively. The mean of this index in the control group before the intervention was 15.50 ± 3.25, 11.55 ± 3.43 and 13.22 ± 3.33. After the intervention, it reached 15.15 ± 1.87, 12.22 ± 2.15 and 13.17 ± 2.34. There was a statistically significant difference between the mean indices of depression (p=0.00), anxiety (p=-0.02) and stress (p˂0.001) in the test group before and after the intervention. However, this difference in the control group was not significant (p ≥ 0.05). The core of caring for patients with chronic diseases involves using safe and low-complication treatment methods. The study findings show that bromelain capsules can effectively alleviate depression, anxiety and stress. Therefore, it is recommended that healthcare providers, especially nurses, consider using bromelain for patients with diabetes and other acute and chronic diseases.

A natural history study of pediatric patients with early onset of GM1 gangliosidosis, GM2 gangliosidoses, or gaucher disease type 2 (RETRIEVE)

BackgroundThe GM1 and GM2 gangliosidoses and type 2 Gaucher disease (GD2) are inherited lysosomal storage disorders with most cases having symptom onset in infancy and reduced life expectancy. The conditions are rare, and there is therefore a need for accurate and up to date information concerning the disease course and survival to assist in the design of clinical trials. RETRIEVE is a natural history study aiming to: (1) collect data on the survival of patients with early-onset (onset of first neurological manifestation before 24 months of age) GM1, GM2, or GD2; (2) collect data that could constitute a historical control group for future clinical trials; and (3) evaluate whether the conditions can be assessed together in a single interventional clinical trial. Group A included patients who were deceased or with unknown survival status at enrollment and was thus limited to retrospective data. Group B included patients who were alive at enrollment, who were followed prospectively with additional retrospective data collection.ResultsGroup A included 185 patients (60 with GM1, 78 with GM2, and 47 with GD2), and Group B included 40 patients (18 with GM1, 16 with GM2, and 6 with GD2). Mean and median age at diagnosis and age at onset of first neurological manifestation were youngest in patients with GD2 and oldest in patients with GM2 in both groups. In Group A, median (95% CI) survival was 19.0 (18.0, 22.0), 44.0 (37.0, 51.9) and 14.0 (10.0, 16.0) months in patients with GM1, GM2 and GD2, respectively. In Group B, hypotonia was experienced by most patients with GM1 (17/18, 94.4%), and was less common in patients with GM2 (12/16, 75.0%) and GD2 (4/6, 66.7%). Strabismus and splenomegaly were reported in all six patients with GD2.ConclusionsRETRIEVE is one of the largest natural history studies of GM1, GM2, and GD2. Results were generally consistent with the published literature, with differences potentially due to variation in inclusion criteria. The difference in median survival between patients with early-onset GM1, GM2, and GD2 reported in this study suggests that the three diseases should not be pooled for study in clinical trials.

Prediction of low birth weight from fetal ultrasound and clinical characteristics: a comparative study between a low- and middle-income and a high-income country

IntroductionAdverse perinatal outcomes (APO) pose a significant global challenge, particularly in low- and middle-income countries (LMICs). This study aims to analyse two cohorts of high-risk pregnant women for APO to...

Nurses' Knowledge and Skills After Use of an Augmented Reality App for Advanced Cardiac Life Support Training: Randomized Controlled Trial.

Advanced cardiac life support (ACLS) skills are essential for nurses. During the COVID-19 pandemic, augmented reality (AR) technologies were incorporated into medical education to increase learning motivation and accessibility. This study aims to determine whether AR for educational applications can significantly improve crash cart learning, learning motivation, cognitive load, and system usability. It focused on a subgroup of nurses with less than 2 years of experience. This randomized controlled trial study was conducted in a medical center in southern Taiwan. An ACLS cart training course was developed using AR technologies in the first stage. Additionally, the efficacy of the developed ACLS training course was evaluated. The AR group used a crash cart learning system developed with AR technology, while the control group received traditional lecture-based instruction. Both groups were evaluated immediately after the course. Performance was assessed through learning outcomes related to overall ACLS and crash cart use. The Instructional Materials Motivation Survey, System Usability Scale, and Cognitive Load Theory Questionnaire were also used to assess secondary outcomes in the AR group. Subgroup analyses were performed for nurses with less than 2 years of experience. All 102 nurses completed the course, with 43 nurses in the AR group and 59 nurses in the control group. The AR group outperformed the control group regarding overall ACLS outcomes and crash cart learning outcomes (P=.002; P=.01). The improvement rate was the largest for new staff regardless of the overall learning effect and the crash cart effect. Subgroup analysis revealed that nurses with less than 2 years of experience in the AR group showed more significant improvements in both overall learning (P<.001) and crash cart outcomes (P<.001) compared to their counterparts in the control group. For nurses with more than 2 years of experience, no significant differences were found between the AR and control groups in posttraining learning outcomes for the crash cart (P=.32). The AR group demonstrated high scores for motivation (Instructional Materials Motivation Survey mean score 141.65, SD 19.25) and system usability (System Usability Scale mean score 90.47, SD 11.91), as well as a low score for cognitive load (Cognitive Load Theory Questionnaire mean score 15.42, SD 5.76). AR-based learning significantly improves ACLS knowledge and skills, especially for nurses with less experience, compared to traditional methods. The high usability and motivational benefits of AR suggest its potential for broader applications in nursing education. ClinicalTrials.gov NCT06057285; https://clinicaltrials.gov/ct2/show/NCT06057285.

Fasting mimicking diet during neo-adjuvant chemotherapy in breast cancer patients: a randomized controlled trial study

ObjectivePreclinical evidences suggests that while fasting can reduce the side effects and toxicity of chemotherapy, it can make cancer cells more susceptible to chemotherapy. This study aimed to examine the effects of fasting mimicking diet (FMD) during neo-adjuvant chemotherapy in breast cancer (BC) patients.MethodsForty-four newly diagnosed human epidermal growth factor receptor 2-negative (HER2-negative) patients with BC were randomized equally into two groups (22 each), to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy. This FMD was repeated every 3 weeks for 8 cycles. Efficacy, toxicity, hematologic, metabolic, and inflammatory parameters were measured and compared.ResultsThe occurrence of grade III vomiting and neutropenia in the control group was significantly higher than the FMD group (P = &amp;lt;0.001 and p = 0.04 respectively). Erythrocytes (p = 0.01) and neutrophils (p = 0.002) counts were significantly higher in FMD group compared to control group after cycle 8. There was a significant increase in median glucose and median insulin levels (p = 0.01 and p = 0.005, respectively) in the control group between baseline and after cycle 8. While, the median Insulin-like growth factor-1 (IGF1) (p = 0.006) and hs-CRP (p = 0.02) levels were significantly decreased in the FMD group. At the end of study (after cycle 8), the median glucose level was significantly higher in control group (p = 0.008), while the median hs-CRP level was significantly lower in FMD group (p = 0.01). The Miller and Payne pathological response 4/5 (90–100% tumor cell loss) and the radiologically complete or partial response, as measured by MRI or ultrasound before surgery occurred more frequently in FMD group compared to the controls (p = 0.01).ConclusionFasting mimicking diet was well tolerated during chemotherapy and reduced toxicity of chemotherapy and also, had beneficial effects of some metabolic parameters.Clinical Trial Registrationhttps://irct.behdasht.gov.ir/user/trial/61386/view.

The Effectiveness of Therapeutic Exercise Interventions With Virtual Reality on Balance and Walking Among Persons With Chronic Stroke: Systematic Review, Meta-Analysis, and Meta-Regression of Randomized Controlled Trials.

Well-targeted balance, walking, and weight-shift training can improve balance capabilities in the chronic phase of stroke. There is an urgent need for a long-term approach to rehabilitation that extends beyond the acute and subacute phases, supporting participation without increasing the demand for health care staff. This study aims to evaluate the effectiveness of therapeutic exercise interventions with virtual reality (VR) training on balance and walking at the activity and participation levels in individuals with chronic stroke, compared with control groups receiving no treatment, conventional physical therapy, specific training, similar treatment, or identical treatment without VR. Studies were searched across 6 databases. The inclusion criteria were as follows: Adults aged 18 years or older with a stroke diagnosis for at least 6 months (population). Therapeutic exercises within a VR environment, using VR glasses or interactive games (intervention). Control groups without the use of VR (including no treatment, conventional physical therapy, specific training, similar treatment without VR, or identical treatment without the additional use of VR; comparison). We evaluated the Berg Balance Scale score, Functional Reach Test performance, Activities-specific Balance Confidence Scale score, Six-minute Walk Test, Two-minute Walk Test, 10-meter Walk Test results, and cadence (outcome measures). We investigated randomized controlled trials (study design). A meta-analysis and a meta-regression analysis were conducted to evaluate whether the content of VR interventions or control groups, as well as the level of VR immersion used, was related to balance or walking outcomes. A total of 43 randomized controlled trials involving 1136 participants were included in this review. The use of VR training in therapeutic exercise interventions had a large effect on balance (standardized mean difference 0.51, 95% CI 0.29-0.72; P<.001) and a moderate effect on walking (standardized mean difference 0.31, 95% CI 0.09-0.53; P=.006) in individuals with chronic stroke, compared with pooled control groups (no treatment, conventional physical therapy, specific training, similar treatment, or identical treatment without the use of VR). According to the meta-regression findings, the content of VR interventions (P=.52), the type of control groups (P=.79), and the level of VR immersion (P=.82) were not significantly related to the pooled balance or walking outcomes. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) was moderate for balance and low for walking. Therapeutic exercise training with VR had a positive, albeit moderate, effect on balance and a low impact on walking at the level of activity (capacity), even in the chronic phase of stroke, without serious side effects. The results are applicable to working-aged stroke rehabilitees who are able to walk without assistance. Further research is needed with defined VR methods and outcomes that assess performance at the level of real-life participation.

Predictive model for converting optic neuritis to multiple sclerosis; decision tree in focus.

Optic neuritis (ON) can be an initial clinical presentation of multiple sclerosis This study aims to provide a practical predictive model for identifying at-risk ON patients in developing MS. We utilized data from the Optic Neuritis Treatment Trial study, which enrolled 457 patients aged from 18 to 46 years, all diagnosed with acute ON. These patients underwent up to 15 years of neurological and ophthalmologic examinations and imaging. The selection of variables for the developing model was based on clinical importance and statistical significance, and any missing values were appropriately addressed. We developed a Decision Tree (DT) classifier as the primary model and manually tuned its hyperparameters for optimal performance. We employed SHapley Additive exPlanations (SHAP) for feature importance evaluation. All analysis was performed using Python version 3.10.9 and its associated libraries. A total of 388 patients completed the study, of which 154 developed clinically definite multiple sclerosis (CDMS). It was observed that 61% of patients with magnetic resonance imaging (MRI) lesions developed CDMS. The final variables selected for analysis were MRI lesions, neurologic history, ON type, gender, and visual field mean deviation. The DT model achieved an accuracy of 70.1% during cross-validation and 69.1% on the test set, with an area under the curve of 74.9% and 71.7%, respectively. Comparative analysis of DT with other models showed similar performance. SHAP analysis revealed that MRI lesions and ON type emerged as the two most significant features, with relative importance of 61% and 18%, respectively. The decision tree model, with satisfactory performance, effectively stratifies patients, based on baseline findings and offers valuable insights for informed decision-making by physicians.

Chest CT assess the impact of omalizumab treatment on airway remodeling in refractory asthma.

BackgroundTo evaluate the benefits of omalizumab treatment in patients through real-world follow-up and assess the impact of omalizumab treatment on airway remodeling using chest CT. MethodsThis is a single-center prospective, observational study included Chinese patients with refractory asthma who received omalizumab treatment from May 2021 to December 2022. We collected real-world clinical data, including their hospitalization information, pulmonary function, FENO, laboratory assessment, ACT scores, chest CT at baseline and every follow-up month. A comparison was made between the pre-treatment and post-treatment laboratory indicators, pulmonary function, airway parameters, and mucous plug scores under chest CT. ResultsThis study included a total of 61 patients with refractory asthma treated with omalizumab. The study found that: ①regardless of whether the treatment lasted for a full four months or not, it significantly improved patient asthma control scores and reduced hospitalization costs and length of stay (p<0.05). ②After four months of treatment, pulmonary ventilation function examination revealed significant improvements (p<0.05) in MEF75, MEF50, MEF75/25, PEF, and FEV1/FVC. ③After four months of omalizumab treatment, the ratio of wall thickness and outer radius (T/D) and wall area percentage (WA%) of the bronchial wall decreased significantly (p<0.05). ④After medication, the expression of airway mucous plugs decreased. ConclusionsOmalizumab treatment can reduce airway wall thickness, decrease the percentage of airway wall area, and the expression of airway mucous plugs, thereby improving airflow limitation. Utilizing chest CT provides a novel and intuitive assessment of the efficacy of omalizumab treatment. Trial registrationThis study was registered in Chinese Clinical Trial Registry, the number is ChiCTR2100046343.

Effectiveness of a guided multicomponent internet and mobile gratitude training program - A pragmatic randomized controlled trial

ObjectiveTo investigate the effectiveness of a guided, internet- and smartphone-based gratitude intervention on the transdiagnostic risk-factor ‘repetitive negative thinking’. The multicomponent intervention integrates a variety of gratitude exercises, targeting the cognitive, emotional and behavioural facets of gratitude. MethodTwo hundred adults with pronounced repetitive negative thinking were recruited from the general population. Participants were randomly assigned to either a four-session guided gratitude intervention (n = 100) or waiting list (n = 100). The primary outcome was repetitive negative thinking three months after randomization, with exploratory assessments at six weeks and six months, the latter just for participants in the intervention group. ResultsFollowing the intention-to-treat principle, by analyses of covariance (ANCOVA), the gratitude intervention group exhibited significantly lower levels of repetitive negative thinking than controls at three months, with d = 0.66, 95 % CI [0.37, 0.94] maintained at six-month follow-up. Significant and meaningful beneficial effects were observed in symptoms of depression (d = 0.42) and generalized anxiety (d = 0.38). These effects were notably stronger in intervention completers who finished at least three sessions. ConclusionsResults suggest that a multicomponent gratitude intervention is effective at reducing repetitive negative thinking. Multicomponent interventions may be a next step needed to fully realize the potential of gratitude interventions. Such interventions could expand the repertoire of transdiagnostic interventions, especially for repetitive negative thinking. Furthermore, due to its positive connotations, gratitude is a candidate for an indirect intervention aimed at reducing the burden of depression in the general population. Trial registrationThe study is registered in the German Clinical Trial Register (approved primary register of the WHO) as DRKS00006825. The trial protocol can be assessed at: https://www.drks.de/

Excess weight by degree and duration and cancer risk (ABACus2 consortium): a cohort study and individual participant data meta-analysis

Elevated body mass index (BMI)≥25kg/m2 is a major preventable cause of cancer. A single BMI measure does not capture the degree and duration of exposure to excess BMI. We investigate associations between adulthood overweight-years, incorporating exposure time to BMI ≥25kg/m2, and cancer incidence, and compare this with single BMI. In this cohort study and individual participant data meta-analysis, we obtained data from the ABACus 2 Consortium, consisting of four US cohorts: Atherosclerosis Risk in Communities (ARIC) study (1987-2015), Women's Health Initiative (WHI; 1991 to 2005 [main study], to 2010 [Extension 1], and to 2020 [Extension 2]), Prostate, Lung, Colorectal, Ovarian Cancer Screening (PLCO) Trial (1993-2009), NIH-AARP Diet and Health Study (1996-2011), and one European cohort, the European Prospective Investigation into Cancer and Nutrition (EPIC; participants enrolled in 1990 and administrative censoring was centre-specific). Participants with at least 3 BMI measurements and complete cancer follow-up data were included. We calculated overweight-years: degree of overweight (BMI ≥25kg/m2) multiplied by the duration of overweight (years). Using random effects two-stage individual participant data meta-analyses, associations between cancer and overweight-years, single BMI, cumulative overweight degree and duration, measured at the same time and captured over a median of 41 years in men and 39 years in women, were evaluated with Cox proportional hazards models. Models were age-adjusted or multivariable (MV) adjusted for baseline age, ethnicity, alcohol, smoking and hormone replacement therapy (HRT). Harrell's C-statistic of metrics were compared. This study is registered at PROSPERO, CRD42021238270. 720,210 participants, including 312,132 men and 408,078 women, were followed up for cancer incidence over a median 9.85 years (interquartile range (IQR) 8.03, 11.67) in men and 10.80 years (IQR 6.05, 15.55) in women. 12,959 men (4.15%) and 36,509 women (8.95%) were diagnosed with obesity-related cancer. Hazard ratios for obesity-related cancers in men, per 1 standard deviation (SD) overweight-years were 1.15 (95% CI: 1.14, 1.16, I2: 0) age-adjusted and 1.15 (95% CI: 1.13, 1.17, I2: 0%) MV-adjusted and per 1SD increment in single BMI were 1.17 (95% CI: 1.16, 1.18, I2: 0) age-adjusted and 1.16 (95% CI: 1.15, 1.18, I2: 0%) MV-adjusted. The HR for overweight-years in women per 1 SD increment was 1.08 (95% CI: 1.04, 1.13, I2: 82%) age-adjusted and 1.08 (95% CI: 1.04, 1.13, I2: 83%) MV-adjusted and per 1SD increment in single BMI was 1.10 (95% CI: 1.07, 1.14, I2: 72%) age-adjusted and 1.11 (95% CI: 1.07, 1.15, I2: 79%) MV-adjusted. C-statistics for overweight-years and single BMI for obesity-related cancers were 0.612 (95% CI: 0.578, 0.646) and 0.611 (95% CI: 0.578, 0.644) respectively for men and 0.566 (95% CI: 0.534, 0.598) and 0.573 (95% CI: 0.546, 0.600) for women. Adulthood degree and duration of excess BMI were associated with cancer risk. Both factors should be considered in cancer prevention strategies and policies. This study only focused on adulthood exposure to excess BMI, so the minimal differences in the predictive performance between adiposity metrics may be due to underestimation of cumulative excess BMI exposure. Cancer Research UK, the Manchester NIHR Biomedical Research Centre, the National Cancer Institute, the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, U.S. Department of Health and Human Services, the Intramural Research Program of the National Cancer Institute, the International Agency for Research on Cancer, Imperial College London, European Commission (DG-SANCO), the Danish Cancer Society, Ligue Contre le Cancer, Institut Gustave-Roussy, Mutuelle Générale de l'Education Nationale, Institut National de la Santé et de la Recherche Médicale, Deutsche Krebshilfe, Deutsches Krebsforschungszentrum, German Federal Ministry of Education and Research, the Hellenic Health Foundation, Associazione Italiana per la Ricerca sul Cancro-AIRC-Italy and National Research Council, Dutch Ministry of Public Health, Welfare, and Sports, Netherlands Cancer Registry, LK Research Funds, Dutch Prevention Funds, Dutch Zorg Onderzoek Nederland, World Cancer Research Fund, Statistics Netherlands, Health Research Fund, Instituto de Salud Carlos III, regional Spanish governments of Andalucía, Asturias, Basque Country, Murcia, and Navarra, the Catalan Institute of Oncology, Swedish Cancer Society, Swedish Scientific Council, and Region Skåne and Region Västerbotten, and the Medical Research Council.

Kids save lives: Who should train schoolchildren in resuscitation? A systematic review

AimCPR training for schoolchildren to increase bystander CPR-rates is widely applied. HCPs are regarded as the instructor gold standard, but using non-HCP instructors (e.g., peer-tutors, schoolteachers, medical students) challenges that. This systematic review assesses whether cardiopulmonary resuscitation (CPR) training for children led by peer-tutors, schoolteachers, or medical students results in different learning outcomes to training by health-care professionals (HCPs). MethodsWe searched studies that compared CPR training for schoolchildren (population) delivered by peer-tutors, schoolteachers, or medical students (intervention), with training led by HCPs (comparison), assessing student knowledge, skills, willingness and/or confidence to perform CPR (outcome). We included randomized and non-randomized controlled trials (study design). Medline, Embase, Psychinfo, Cinahl, Cochrane, Scopus, Web of Science, and Eric were searched from inception until December 23rd, 2023 (timeframe). Two independent reviewers performed title, abstract, full text screening, bias assessment, and grading of certainty of evidence. We followed the Preferred Reporting Items for a Systematic Review and Meta-Analysis (PRISMA) guidelines, and registered the review with PROSPERO. ResultsOf 9′092 studies identified, 14 were included. Comparison of intervention groups to HCP-led training showed similar overall results (knowledge, skills, self-confidence). Superior results for HCP training were only reported for ‘ventilation volume’, while schoolteachers and medical students achieved superior knowledge transfer. A meta-analysis was possible for ‘compression depth’ between peer-tutors and HCPs showing no significant differences. Certainty of evidence was ‘low’ to ‘very low’. ConclusionThis systematic review of CPR training for school children revealed that peer-tutors, schoolteachers and medical students achieve similar educational outcomes compared to those of HCPs. Non-HCPs training schoolchildren is an appropriate cost-efficient alternative and easy to implement in school curricula.

Effect of Implicit Learning Methods With the External Focus of Attention on Bowling Skills in Children With Autism Spectrum Disorder: A Randomized Control Trial Study.

The aim of the current study was to compare implicit learning methods with an emphasis on the external focus of attention on bowling skill in autistic children. Twenty children with autism spectrum disorder (ASD) were selected. After the participants were randomly divided into two groups, the pretest was performed, evaluating the participants both quantitatively (score of bowling pins falling) and qualitatively (TGMD3 subscale test of underhand ball throwing). Group A was trained using the errorless learning method with the external focus of attention, while Group B was trained using the analogical learning method with the external focus of attention. The results showed that analogical learning with the external focus of attention has significant effects (p≤0.05) on both bowling and underhand ball-throwing skills in autistic children. Errorless learning with external focus of attention, on the other hand, had a significant effect (p≤0.05) on the bowling skill. The results of the research showed that analogical learning with an external focus of attention can be effective in developing both bowling skill and underhand ball-throwing skill in children with ASD; however, errorless learning with an external focus of attention was useful in developing bowling skill and failed to show a significant effect on enhancing the underhand ball-throwing skill in children diagnosed with ASD. IRCT20220920056007N1.

The Effect of Combined Exercises with and Without Blood Flow Restriction and Vitamin D Supplementation on Serum Levels of Alkaline Phosphatase in Elderly Women: A Randomized Clinical Trial Study

The Effect of Combined Exercises with and Without Blood Flow Restriction and Vitamin D Supplementation on Serum Levels of Alkaline Phosphatase in Elderly Women: A Randomized Clinical Trial Study

Association of fall risk-increasing drugs with falls in generally healthy older adults: a 3-year prospective observational study of the DO-HEALTH trial

BackgroundThe association between fall risk-increasing drugs (FRIDs, medications known to be associated with falls) and the number of falls among generally healthy and active community-dwelling older adults is understudied. Prior studies have focused on individual medication classes or have predominantly relied on retrospective assessments of falls. The aim of this study was to investigate the association between FRID use at baseline and the prospective incidence rates of total, injurious and recurrent falls in community-dwelling older adults.MethodsThis is a 3-year observational analysis of DO-HEALTH, a randomized controlled trial, among community-dwelling adults aged ≥ 70 years without major diseases at baseline. The main exposures were use of at least one FRID and multiple FRIDs (≥ 2 FRIDs) at baseline. The number of total falls (including high- and low-trauma falls, as well as injurious falls) over 3 years of follow-up was defined as the primary outcome, and the number of injurious and the number of recurrent total falls (≥ 2 falls), as the two separate secondary outcomes. To examine these associations, separate negative binomial regression models controlled for the fixed effects of treatment allocation in the DO-HEALTH trial, study site, fall in the last year, age, sex, BMI, and walking aid were used. Additionally, an offset of the logarithm of each participant’s time in the study was included in the models.ResultsA total of 2157 participants were included, with a baseline median age of 74.0 years, 61.7% of whom were women, and 41.9% having experienced a prior fall in the year preceding enrolment. At baseline, 908 (42.1%) participants used at least one FRID, and 351 (16.3%) reported multiple FRIDs use. Prospectively, over 3 years of follow-up, 3333 falls were reported by 1311 (60.8%) out of the 2157 participants. Baseline use of at least one FRID was significantly associated with increased incidence rates of total falls (incidence rate ratio (IRR) [95% Confidence Interval (CI)] = 1.13 [1.01–1.27]), injurious falls (IRR = 1.15 [1.02–1.29]), and recurrent falls (IRR = 1.12 [1.01–1.23]) over 3 years. These associations were most pronounced among users of multiple FRIDs, with increased incidence rates of total falls (IRR = 1.22 [1.05–1.42]), injurious falls (IRR = 1.33 [1.14–1.54]) and recurrent falls (IRR = 1.14 [1.02–1.29]).ConclusionOur results suggest that FRID use is associated with increased prospective incidence rates of total, injurious, and recurrent falls even among generally healthy older adults.Trial registrationDO-HEALTH is registered as NCT01745263 on clinicaltrials.gov, with a registration date of 2012-12-06.