This study compares the efficacy of hydrodilatation (HD) alone with intra-articular corticosteroid injection (ICI) in treating frozen shoulder (FS). A total of 48 patients with FS were randomly assigned to two groups: 24 patients received HD treatment, while the other 24 patients received ICI treatment. HD involved 20 mL 0.9% normal saline solution with 3 mL 2% lidocaine, and ICI included 1 mL of 40 mg/mL methylprednisolone acetate with 1 mL 2% lidocaine and 3 mL normal saline. Outcome measures included Visual Analog Scale (VAS), Shoulder Pain and Disability Index (SPADI), and passive range of motion (ROM) at baseline, two-, four-, and eight-week follow-ups. Both treatments demonstrated significant improvement in the VAS, SPADI, and passive ROM, when between-times comparison was conducted in each group at all follow-up points over the eight-week study period (p < 0.001). However, no significant differences were found in between groups comparison at study end (p > 0.05), with no significant interaction between groups and times (p > 0.05). Absolute changes from baseline to eight-week follow-up were not significantly different between HD and ICI (p > 0.05). In the short term, HD alone demonstrates strong efficacy in managing FS, matching the effectiveness of ICI.

Apical root resorption and alveolar bone loss are potential complications associated with orthodontic treatment. This study aimed to assess apical root resorption and alveolar bone height following orthodontic treatment of moderate crowding with labial vs. lingual fixed appliances using CBCT imaging.

All patients meeting the eligibility criteria were included from March 2022 to June 2022 at the University of Damascus Faculty of Dentistry, Department of Orthodontics. The study involved patients diagnosed with Class I malocclusion and moderate crowding in both arches that could be treated on a non-extraction basis. Participants were randomly divided into two groups. One group was treated using lingual appliances (DTC® IN-Tendo JK-SL, DTC Medical Apparatus Co., Hangzhou, China) with a 0.018-inch slot. The sequence of archwires used included 0.012″, 0.014 0.016″ nickel-titanium, 0.016″×0.022″ TMA, 0.016″×0.022″ stainless steel, and 0.017″×0.025″ stainless steel. The other group received treatment with labial straight-wire appliances (AO Mini Master® - MBT System, metal brackets, Sheboygan, WI, USA) also featuring a 0.018-inch slot. The sequence of archwires used was 0.012″, 0.014″, 0.016″ nickel-titanium, 0.016″×0.022″ nickel-titanium, 0.016 and 0.017″×0.025″ stainless steel. The CBCT images were taken before the commencement of treatment (T0) and one day following the end of treatment (T1). The apical root resorption and alveolar bone height of the upper and lower teeth were assessed at these assessment times. Paired-sample t-test used to analyse the intergroup differences, while a two-sample t-test was employed to assess intragroup changes. The significance level was set at P<0.004 after adjustment using Bonferroni's correction.

Out of forty patients, nineteen patients in each group were included in the statistical analysis (16 men and 24 women; mean age: 21.3years). In both groups, there was a significant decrease in the lengths of all studied teeth at T1 (P<0.004). The apical resorption was significantly greater in the lingual appliance group for lower central and lateral incisors compared to the labial appliance group (0.64mm, 0.7, respectively). The mean lingual bone loss in the lingual appliances was statistically greater than that in the labial appliances for lower central incisors (0.53mm), while the mean buccal bone loss in the labial appliance group was statistically greater than that in the lingual appliance group for the lower lateral incisors (0.52mm).

The use of DTC® lingual or AO Mini Master® labial brackets with archwire sequences is associated with clinically acceptable mild to moderate root resorption and clinically insignificant alveolar bone loss when treating moderate crowding. The record resorption in both cases is less than 1.34mm. The lingual appliances cause greater resorption of lower incisors than labial appliances. Lingual bone loss is greater with lingual orthodontic appliances for lower central incisors, while vestibular bone loss is greater with labial orthodontic appliances for the lower later al incisors.

Repetitive transcranial magnetic stimulation (rTMS) has shown promise as an intervention for pain. An unexplored research question is whether the delivery of rTMS prior to pain onset might protect against a future episode of prolonged pain. The present study aimed to determine whether (1) 5 consecutive days of rTMS delivered prior to experimentally induced prolonged jaw pain has a prophylactic effect on future pain intensity and (2) whether these effects were accompanied by increases in corticomotor excitability (CME) and/or sensorimotor peak alpha frequency (PAF). On each day from day 0 to 4, 40 healthy individuals received a single session of active (n = 21) or sham (n = 19) rTMS over the left primary motor cortex. Peak alpha frequency and CME were assessed on day 0 (before rTMS) and day 4 (after rTMS). Prolonged pain was induced via intramuscular injection of nerve growth factor in the right masseter muscle after the final rTMS session. From days 5 to 25, participants completed twice-daily electronic diaries including pain on chewing and yawning (primary outcomes), as well as pain during other activities (eg, talking), functional limitation in jaw function and muscle soreness (secondary outcomes). Compared to sham, individuals who received active rTMS subsequently experienced lower pain on chewing and yawning. Furthermore, active rTMS led to an increase in PAF. This is the first study to show that rTMS delivered prior to prolonged pain onset can protect against future pain. Our findings suggest that rTMS may hold promise as a prophylactic intervention for pain.

This study assessed the impact of prenatal High-Intensity Interval Training (HIIT) and educational (EDU) interventions on depression symptoms, psychological well-being, and health among postpartum women. Fifty-three Caucasian women in uncomplicated singleton pregnancies were divided into HIIT (n = 34) and EDU (n = 19) groups. Depression symptoms were measured using the Beck Depression Inventory and Edinburgh Postnatal Depression Scale. Psychological well-being and mental and physical health were assessed using the Flourishing Scale and SF-12 at three time points: before and after an 8-week intervention during pregnancy, and five months postpartum. There were no between-group differences in all three assessments, both in the severity of depression symptoms, psychological well-being, as well as physical and mental health. Both groups showed an increase in postpartum scores for depressive symptoms, although mean scores were still relatively low. A postpartum decline in well-being and mental health indicators was significant only in the EDU group. Both interventions had similar effects on depressive symptoms and well-being. Prenatal HIIT may have the potential to maintain postpartum mental health, but this requires further exploration.

This study investigated the effects of a high-impact exercise regimen compared with a reference group on systemic cytokine levels in patients with mild knee osteoarthritis (OA). Furthermore, associations between cytokines and magnetic resonance imaging (MRI) transverse relaxation time (T2) mapping and metabolic equivalent task hours (MET-hours) during leisure-time physical activity (LTPA) were assessed.

In this secondary analysis, 73 postmenopausal women aged 50-65 years with mild knee OA were randomized to a 12-month high-impact aerobic/step aerobics training group (n ​= ​35) or a non-training reference group (n ​= ​38). The serum cytokine levels, including interleukin-1 alpha (IL-1α), IL-2, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17, interferon-gamma (IFN-γ), and tumor necrosis factor alpha (TNF-α), were determined via multiplex cytokine assays. The cartilage structure of the medial tibial condyle was assessed by MRI T2 mapping. The primary outcome was between-group differences in cytokine level changes.

After a 12-month follow-up, no significant differences in cytokine level changes were found between the groups. In the intervention group, 12-month changes in TNF-α levels were associated with changes in medial tibial condyle T2. In the reference group, 12-month changes in IL-10 levels were associated with changes in medial tibial condyle T2 and the number of weekly LTPA MET-hours.

A progressive high-impact exercise regimen did not affect systemic cytokine levels compared to the reference group and could therefore offer a possible mode of exercise for postmenopausal women with mild knee OA.

ISRCTN58314639.

Recent expert consensus publications have highlighted the issue of poor reproducibility in magnetic resonance spectroscopy (MRS) studies, mainly due to the lack of standardized reporting criteria, which affects their clinical applicability. To combat this, guidelines for minimum reporting standards (MRSinMRS) were introduced to aid journal editors and reviewers in ensuring the comprehensive documentation of essential MRS study parameters. Despite these efforts, the implementation of MRSinMRS standards has been slow, attributed to the diverse nomenclature used by different vendors, the variety of raw MRS data formats, and the absence of appropriate software tools for identifying and reporting necessary parameters. To overcome this obstacle, we have developed the REproducibility Made Easy (REMY) standalone toolbox. REMY software supports a range of MRS data formats from major vendors like GE (.7), Siemens (.ima, .rda, .dcm), Philips (.spar/.sdat), and Bruker (.method), and MRS-NIfTI (.nii/nii.gz/.json) files facilitating easy data import and export through a user-friendly interface. REMY employs external libraries such as spec2nii and pymapVBVD to accurately read and process these diverse data formats, translating complex header information into a comprehensive structure that adheres to consensus reporting standards, thereby ensuring compatibility and ease of use for researchers in generating reproducible MRS research outputs. Users can select and import datasets, choose the appropriate vendor and data format, and then generate an MRSinMRS table, log file, and methodological documents in both Latex and PDF formats by just clicking one button. No coding knowledge is required, making the tool accessible to a wider range of users, including researchers and clinicians without programming expertise. This eliminates technical challenges related to data formatting and reporting. REMY effectively populated key sections of the MRSinMRS table with data from all supported file types. Accurate generation of hardware parameters including field strength, manufacturer, and scanner software version were demonstrated. However, it could not input data for RF coil and additional hardware information due to their absence in the files. For the acquisition section, REMY accurately read and populated fields for the pulse sequence name, nominal voxel size, repetition time (TR), echo time (TE), number of acquisitions/excitations/shots, spectral width (Hz), and number of spectral points, significantly contributing to the completion of the "Acquisition" fields of the table. Furthermore, REMY generates a boilerplate methods text section for manuscripts. The use of REMY will facilitate more widespread adoption of the MRSinMRS checklist within the MRS community, making it easier to write and report acquisition parameters effectively.

IntroductionAlthough there is growth in the approach to telerehabilitation (TLRH) in different pathologies, research on TLRH for the management of low back pain is scarce and controversial. Thus, the purpose of this study was to analyze whether a TLRH program is as effective as a clinical exercise program in improving pain and different functional variables in patients with nonspecific low back pain (NLBP).MethodA single-blind, two-armed randomized controlled trial was carried out with 68 individuals with chronic NLBP. Participants were randomly allocated to either the TLRH group (TG) (n = 34) or the clinic group (CG) (n = 34). The TG received an exercise-based TLRH video and an educational program on the neurophysiology of pain. The CG received the same pain education and exercise program at the clinic facility supervised by a clinician. Both groups performed 2 weekly sessions for 8 weeks. Active movements of the lumbar spine, pain and range of motion, and kinesiophobia were assessed at baseline, at the end of 8 weeks of treatment, and at 3 months.ResultsStatistically significant differences for time-by-group interaction were identified in range of motion of right (F = 11.668; p = 0.001) and left (F = 4.219; p = 0.042) legs when knee extended test is performed; as well as in pain intensity when the same test (F = 5.176; p = 0.043). Moreover, higher pain level during flexion (F = 5.133; p = 0.009) and extension movements (F = 6.335; p = 0.003) in patients with bilateral pain location than those with unilateral or central pain location has been appreciated.ConclusionA TLRH rehabilitation program via mobile app is as effective as the same exercise program supervised in a clinic.

To determine whether air-filled systems (AFS) provide comparable urodynamic investigation (UDI) trace quality to water-filled systems (WFS), the recommended standard by the International Continence Society.

A total of 490 patients undergoing UDI from April 2021 to January 2022 were included in this non-inferiority randomised controlled trial. Eligible patients were female and male adults with neurogenic lower urinary tract dysfunction (NLUTD). Patients were allocated by block randomisation in a 1:1 ratio to undergo UDI using a WFS (n = 244) or an AFS (n = 246). The primary endpoint was artefact susceptibility evaluated by a 'blinded' assessor using a modified 'Bristol UTraQ' quality scoring scale ranging from 0 to 18, with higher scores indicating a better quality. A clinically meaningful non-inferiority margin was pre-specified as -2 points on the quality scoring scale (AFS-WFS).

The median (interquartile range [IQR]) overall quality score was 14.5 (13.5-15.5) points for the WFS and 15.5 (14.5-16.5) points for the AFS. Inferiority of AFS could be rejected at the pre-specified non-inferiority margin (0.96, 95% confidence interval 0.68-1.25; P < 0.001). Artefacts were more frequent in WFS. Typical artefacts consisted of repeat rectal contractions, poor pressure transmission during cough test at empty bladder, and detrusor resting pressure outside of the physiological range at empty bladder.

Our results indicate that AFS are non-inferior to WFS regarding overall urodynamic trace quality in patients with NLUTD.

Computed tomography (CT) is as safe as invasive coronary angiography (ICA) in the incidence of major adverse cardiovascular events in patients with atypical chest pain. However, the cost-utility of CT and ICA in healthcare after long-term follow-up is still unknown.

A prespecified cost-utility analysis (CUA) of 329 patients with atypical chest pain from a single-centre randomised trial compared CT and ICA. The CUA was conducted from the health sector perspective up to a 3-year follow-up using quality-adjusted life years (QALYs) from the EQ-5D-3L questionnaire. Costs were obtained from each individual's outpatient and inpatient billing data and included cardiovascular medications, hospitalisations, emergency visits, cardiologist visits, and cardiac examinations. The analysis implemented 500 multiple imputations and 1000 bootstrapping iterations per imputed dataset, followed by calculating the net monetary benefit (NMB).

There was no significant difference in mean QALYs at either 1-year (CT: 0.69 (95% CI: 0.66-0.72); ICA: 0.71 (95% CI: 0.68-0.74); difference: -0.02 (-0.06 to 0.03)) or 3-year follow-up (CT: 2.09 (95% CI: 2.00-2.17); ICA: 2.11 (95% CI: 2.02-2.19); difference: -0.02 (95% CI: -0.14 to 0.12)), while the mean cost per patient was significantly lower in the CT compared with the ICA at both 1-year (difference (€): -1647.8, 95% CI: -2198.3 to 1093.3) and at 3-year follow-ups (difference (€): -1543.3, 95% CI: -2228.0 to -830.0). At a willingness-to-pay of €20,000/QALY, the mean incremental NMB of CT over ICA was €1256.5 (164.8-2331.8) at 1-year and €1202.0 (95% CI: -1378.7 to -3961) at 3-year follow-ups.

A CT-first strategy for the management of patients with atypical angina or chest pain was more cost-effective than a direct ICA strategy.

ClinicalTrials.gov NCT00844220.

Question What is the cost-effectiveness of using CT compared to invasive coronary angiography (ICA) for diagnosing coronary artery disease in patients with atypical chest pain? Findings A CT-first diagnostic strategy was €1543 less costly per patient over a 3-year follow-up, yielding similar quality-adjusted life years compared to ICA. Clinical relevance CT offers a cost-effective, non-invasive alternative to ICA for patients with atypical chest pain, reducing healthcare costs significantly without compromising patient-reported outcomes or quality of life.

Labour pain is an unavoidable feature of childbirth and is characterised by extreme intensity. Adequate pain management is thus essential not only from the aspect of physiological pain but also due to the adverse effects of pain on the psychological well-being of parturients. Many studies have shown the benefits of acupoint hot compress. However, to date, little is known about its use for alleviating labour pain. The purpose is to evaluate the effect of acupoint hot compress on relieving pain in primiparous women during the latent phase of the first stage of labour, as well as its effects on key maternal and neonatal outcomes.

This prospective, multicentre, randomised controlled trial will be conducted across 18 institutions in China from January 2024 to August 2025. A total of 1100 primiparous women aged 20-34 years, with singleton pregnancies at 37-41 weeks of gestation, will be enrolled and randomly allocated to two groups using a central stratified block randomisation method. The controls will be treated only with obstetrical care, while those in the intervention group will receive the same obstetrical care as the control group, with the addition of acupoint hot compress therapy at 42±2°C for 4 hours, starting 1 hour after the onset of regular uterine contractions during the latent phase of labour. The primary outcome will be the pain intensity measured at 1, 3 and 5 hours after the onset of regular uterine contractions using a Visual Analog Scale.

The study has been approved by the ethics committee of Women's Hospital, School of Medicine, Zhejiang University (No. IRB-20230379-R). The results of the main trial will be submitted for publication in a peer-reviewed journal.

This trial is registered at Chinese Clinical Trial Registry, ChiCTR2300079244.

The paucity of exercise rehabilitation services for cancer survivors indicates a research-to-practice gap. Dissemination and Implementation research addresses this gap by focusing on the adoption, implementation, and sustainability of evidence-based interventions. Dissemination, the active process of sharing research findings, is critical to the implementation of evidence-based practice. This systematic review examined adherence of exercise oncology trial protocols to the SPIRIT 2013 checklist items pertaining to dissemination planning, items 31a, 31b, and 31c, which address how dissemination is planned, authorship eligibility is considered, and what plans are in place to share data and the protocol.

A systematic review was conducted following the PRISMA guidelines. EMBASE, MEDLINE, CINAHL, Web of Science-Core Collection, Google Scholar, and the Central Trial Registry via Cochrane were searched (16/05/2024). Title and abstract screening, full-text review, and data extraction were completed in duplicate.

Eighty-six trial protocols were included, thirty-one (36.1%) did not report dissemination plans. Item 31 was reported as follows (n = number of trials, frequency (%)); 31a plans to communicate trial results to: participants (n = 19, 22.1%), healthcare professionals (n = 43, 50%), the public (n = 25, 29.2%), and other relevant groups (n = 22, 25.6%), 31b: author eligibility (n = 3, 3.5%) and plans regarding use of professional writers (n = 4, 4.7%), and 31c plans for granting access to participant level dataset (n = 28, 32.6%), full protocol (n = 1, 1.2%) and statistical code (n = 1, 1.2%). Peer-reviewed journal (n = 41, 47.67%) and conferences/professional meetings (n = 38, 44.2%) were the most frequently reported planned dissemination strategies.

Reporting of the SPIRIT 2013 checklist Item 31 is generally low in exercise oncology trial protocols. Greater consideration of dissemination planning is required to support the implementation of exercise oncology research into practice.

https://doi.org/10.17605/OSF.IO/M8HFP.

This systematic review aimed to examine the impact of technology- and parent-based psychosocial interventions on family factors among children with cancer, focusing on family dynamics.

Data were sourced from ten databases (CNKI, Wanfang, VIP, Sinomed, the Cochrane Library, Embase, PubMed, Web of Science, Scopus, and CINAHL) up to August 2024. The PRISMA statement guidelines, the Cochrane risk bias assessment tool, and the non-randomized controlled trial risk bias assessment tool were used in this study and experimental and quasi-experimental studies were included. The review protocol is registered in PROSPERO (CRD42023435402).

Twelve studies, including seven randomized controlled trials and five quasi-experimental studies, involving 1,309 parents of children with cancer, were included in the review. These studies utilized various theoretical models and delivered interventions through different modes, such as Internet-based platforms and telehealth. Overall, technology- and parent-based interventions have demonstrated positive effects on family dynamics factors, including family function, communication, coping ability, and family burden.

Technology- and parent-based psychosocial interventions showed promise in enhancing family dynamics factors although intervention methods varied across studies. This review recommends larger-scale randomized controlled trials to evaluate the effectiveness of technology- and parent-based psychosocial interventions on family dynamics factors among this vulnerable population and highlights the potential of such interventions to improve care quality, treatment outcomes, and resource allocation in pediatric oncology.

Hypertension is the predominant risk factor for cardiovascular disease morbidity and mortality, with significant healthcare utilization and expenditure. Pharmaceutical management is habitually adopted; although its long-term effectiveness remains ambiguous, and accompanying adverse effects are disquieting. Peppermint owing to its abundance of menthol and flavonoids, possesses a range of potential hypertensive benefits.

Our previous trial has shown that peppermint is able to mediate significant improvements in systolic blood pressure in healthy individuals. But there has yet to be any randomized placebo-controlled studies, examining the efficacy of peppermint supplementation in hypertensive individuals.

This study proposes a placebo randomized controlled trial, exploring the effects of daily peppermint oil supplementation on outcomes pertinent to hypertensive disease in individuals with pre and stage 1 hypertension.

This 20-day, parallel randomized, placebo-controlled trial will recruit 40 individuals, assigned to receive either 100μL per day of either Peppermint oil or a peppermint flavoured placebo. The primary trial outcome will be the between-group difference in systolic blood pressure from baseline to post-intervention. Secondary outcome measurements will be between-group differences in anthropometric, haematological, diastolic blood pressure/ resting heart rate, psychological wellbeing, and sleep efficacy indices. Statistical analysis will be conducted on an intention-to-treat basis using linear mixed effects models to contrast differences in the changes from baseline to 20-days between the two trial arms.

Ethical approval has been granted by the University of Central Lancashire (HEALTH 01074) and the study has formally been registered as a trial (NCT05561543). Dissemination of the trial findings will be through publication in a peer-reviewed journal.

ClinicalTrials.gov NCT05561543.

HEALTH 01074.

Uptake of the COVID-19 vaccine has been low in the US (~ 22% among adults in 2023 - 241) despite ongoing public health recommendations. This has been linked to many factors including pandemic fatigue, reduced risk perception, dis/misinformation, and recently, symptoms of depression and anxiety. Novel communication and messaging strategies are one potential approach to promote vaccine uptake. This randomized control trial tests two communication-based approaches compared to standard public health messaging on vaccine uptake in a cohort of adult US residents. We completed a 3-arm, parallel-group, assessor-blinded stratified-randomized trial between April-15-2024 and May-2-2024. Eligible individuals were ≥ 18 years old who: 1)had received at least one dose of the COVID-19 vaccine, but, 2)had not received COVID-19 vaccine doses since September-11-2023, and 3)had not been infected with SARS-CoV-2 in the past three months. We purposively sampled eligible individuals with and without symptoms of anxiety and depression. Participants were randomly allocated to: 1) attitudinal inoculation intervention; 2) CBT-kernels intervention; or 3) standard public health messaging intervention. At four-week follow up, these groups showed no meaningful differences in uptake (CBT- kernels:1.6% [95%CI:0.4-2.8]; Inoculation:0.9% [95%CI:0.0-1.8]; and Standard:1.3% [95%CI:0.3-2.4]) or level of vaccine willingness. Successful efforts to increase uptake of the COVID-19 vaccine via theory-enhanced messaging remain elusive.

To evaluate the effectiveness of adding Dynamic Tape® to a progressive load exercise program in patients with patellar tendinopathy.

Randomized controlled trial.

University research.

Forty-eight subjects with patellar tendinopathy.

Participants were divided into two groups: dynamic group, which received progressive load exercises and Dynamic Tape®, and sham group, which received progressive load exercises and sham taping. The intervention was conducted three times per week over 12 weeks.

The pain during decline squatting was assessed using a visual analog scale. The severity of patellar tendinopathy was measured using the Victorian Institute of Sport Assessment-Patella (VISA-P).

There was no effect of group-time interaction for the pain (Z = 0.844, p = 0.472) or severity (Z = 1.275, p = 0.286) of patellar tendinopathy. Reduced pain and severity were observed over time (p < 0.05), however there was no between-group differences (p > 0.05).

Dynamic Tape® does not provide additional benefits when combined with a progressive load exercise program for reducing pain and severity in patellar tendinopathy.

Minimally invasive surgery (MIS) is the standard approach in bariatric surgery. The most common bariatric procedures are sleeve gastrectomy and Roux-en-Y-Gastric Bypass (RYGB). Simulation training, including virtual reality (VR), is useful when learning MIS. Training in pairs has proven beneficial in acquiring basic MIS skills. However, this has not been tested on more complex procedures such as MIS RYGB. The study aimed to assess the learning effects of training MIS RYGB on a VR trainer in pairs compared to solo training.

Medical students (n = 60) were randomized into the intervention group, trained in pairs (n = 30), and the control group, trained solo (n = 30). Both groups needed to train MIS RYGB on a VR trainer under the supervision of trained tutors until proficiency was reached. The MIS RYGB proficiency was defined as 105/110 points according to the Bariatric Objective Structured Assessment of Technical Skills (BOSATS) score. The primary outcome was the number of exercise repetitions until proficiency was reached. Secondary outcomes compared the BOSATS scores, bleeding incidents, and the validated score on current motivation.

The intervention group achieved proficiency with significantly fewer repetitions than the control group (p = 0.002). Most participants in the intervention group reached proficiency by the fifth repetition, and none required an eighth repetition. The intervention group had better BOSATS scores than the control group after the second, fourth, and fifth MIS RYGB (91.1 ± 6.4 vs. 87.1 ± 7.0 points, p = 0.025; 104.0 ± 4.7 vs. 100.3 ± 6.1 points, p = 0.014; 106.2 ± 2.8 vs. 101.9 ± 5.8 points, p = 0.026), respectively. Additionally, the intervention group experienced fewer bleeding complications in the fifth and sixth MIS RYGB repetitions than the control group (2 vs. 10, p = 0.001; 0 vs. 8, p < 0.001, respectively).

Training MIS RYGB on a VR trainer in pairs enables trainees to reach procedural proficiency with fewer exercise repetitions than training alone.

Most minimally invasive surgery (MIS) training curricula involve practical training (PT) and cognitive learning (CL) to different extents. It has been proven that acquiring and training specific skills through CL can improve MIS skills. This study aimed to discover the most efficient combination of these two approaches and examine their effects on acquiring MIS skills in novices.

Sixty medical students without MIS experience participated in this randomized controlled study and were divided into three groups. The first group received the same amount of PT (50%) as CL (50%). The second group focused on PT (75%) compared to the CL (25%). The third group focused more on CL (75%), with less PT implemented (25%). Before and after training, participants performed an ex vivo laparoscopic cholecystectomy (LCHE). Objective Structured Assessment of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Skills (GOALS) scores were used for MIS skill evaluation.

Group 1 improved all four performance assessments (global GOALS 14.3 vs. 18.0, p < 0.001, LCHE-specific GOALS 5.9 vs. 6.9, p = 0.016, global OSATS 19.4 vs. 26.4, p < 0.001, LCHE-specific OSATS 37.9 vs. 46.5, p = 0.004). Group 2 and Group 3 improved three of four performance scores (Group 2: global GOALS 15.0 vs. 18.4, p < 0.001, LCHE-specific GOALS 7.0 vs. 7.7, p = 0.115, global OSATS 19.6 vs. 25.8, p < 0.001, LCHE-specific OSATS 41.3 vs. 50.7, p = 0.001; Group 3: global GOALS 13.8 vs. 17.9, p < 0.001, LCHE-specific GOALS 5.8 vs. 6.6, p = 0.148, global OSATS 18.9 vs. 25.5, p < 0.001, LCHE-specific OSATS 36.8 vs. 43.5, p = 0.034).

A balanced combination of PT and CL seems to offer the most effective training compared to predominantly PT or CL training. All three training modes improved MIS skills in novices.

Postoperative period of Coronary Artery Bypass Grafting can be challenging, with physical and psychological problems and symptoms. We conducted this study to explore the effect of a psycho-educational intervention on anxiety, pain and physiological parameters among Coronary Artery Bypass Grafting surgery patients.

A randomized clinical trial design included one experimental and control group. Data were collected from 56 candidates for coronary artery bypass surgery (n = 28) in the intervention and (n = 28) in the usual care groups. Settings were the cardiac centers of the three teaching, specialty, and subspecialty Nemazee, Faghihi, and Al-Zahra hospitals affiliated with Shiraz University of Medical Sciences (SUMS). The data were collected using a demographic information form, the Short-Form McGill Pain Questionnaire, the Spielberger State-Trait Anxiety Inventory, and the physiological parameters form (systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation). Psycho-educational interventions were performed individually through face-to-face sessions. All tests were two-tailed, and the statistical level was considered 0.05.

The mean scores of state anxiety and pain decreased significantly after the intervention (p < 0.05). Also, psycho-educational interventions affected peripheral oxygen saturation percentage, and breathing rate mean scores (P < 0.05). But, they did not affect the blood pressure and pulse rate (P > 0.05). At the same time, there was no significant difference in the control group.

This study indicated that the pre-operative psycho-educational interventions facilitated intrapersonal caring, reduce state anxiety, relieve pain and stabilize physiological parameters such as peripheral oxygen saturation percentage and breathing rate after surgery among Coronary Artery Bypass Grafting surgery patients. Hence, this intervention is recommended for developing care programs in same population.

https://www.irct.ir/trial/55652 : IRCT20090908002432N8 (2021-09-17).

Background: The early detection of fall risk in older adults is crucial for prevention. This study assessed the 3-Meter Backward Walk Test (3m-BWT) as a predictor of falls. Methods: A retrospective observational case-control study was conducted with 483 community-dwelling participants (mean age 76.3 ± 6.5 years), including 101 individuals with a history of falls in the previous 12 months. A standardized battery of functional assessments was applied. Results: Significant differences were observed between fallers and non-fallers across all functional variables (p < 0.001), with fallers demonstrating slower performance on the 3m-BWT (6.8 ± 3.4 s vs. 5.1 ± 1.3 s). The 3m-BWT showed moderate correlations with Short Physical Performance Battery, 5-repetition Sit-to-Stand, gait speed, and 4-Square Step Test, and a moderate-to-strong correlation with Timed Up-and-Go (r = 0.632), even after adjusting for age, sex, and BMI. Although the 3m-BWT exhibited superior discriminative ability compared to other tests (AUC = 0.655), its predictive power in isolation remains limited. The optimal cut-off point was identified at 5.5 s (sensitivity: 59.5%; specificity: 68.6%), while a threshold of <3.5 s yielded high sensitivity (98%) but low specificity, supporting its use in fall risk screening. Conclusions: These findings support the integration of the 3m-BWT as a complementary tool within comprehensive geriatric assessments, particularly in contexts requiring high sensitivity. Given the multifactorial nature of falls, combining the 3m-BWT with other clinical evaluations and fall history is recommended to enhance risk stratification and inform preventive strategies.

Exclusion criteria are designed to optimize the scientific yield and safety of clinical trials. However, periodic analysis is necessary to understand the impact on trial complexity, enrollment, generalizability, and costs. We analyzed the types of exclusion criteria used among clinical trials performed in subarachnoid hemorrhage (SAH) patients and impact upon exclusion of patients.

We identified trials involving SAH patients that provided a list of exclusion criteria and determined the number and proportion of those trials which used various exclusion criteria, proportion of excluded patients for each of the exclusion criteria and whether Consolidated Standards of Reporting Trials (CONSORT) was used. We also used target trial emulation approach and applied arbitrary trial exclusion criteria to a single center cohort of SAH patients to determine proportions of patients excluded for each of the reasons for exclusion.

A total of 109 trials involving SAH patients were identified, of which 68(62.3%) provided a list of the exclusion criteria. The median number of exclusion criteria was 6 (range 2-9). The most common exclusion criteria were pregnancy (n = 31 trials), SAH due to other causes (trauma, fusiform or mycotic aneurysm, n = 26 trials) and significant liver disease/hepatic insufficiency (n = 19 trials). CONSORT was used in 16(23.5%) trials and 18 (16.5%) trials provided the proportion of patients excluded according to each of the exclusion criteria. In a single center cohort, the highest proportion of patients were excluded because no aneurysm was identified on imaging (23%) followed by withdrawal of care (9.6%) and need for dual anti-platelet treatment (8.6%). The in-hospital mortality was higher in patients who were excluded as compared with those who were included in the hypothetical trial (22 [30.1%] of 73 and 0 [0%] of 31 patients).

Our analysis on exclusion criteria used and proportion of patients excluded in clinical trials involving SAH patients will assist in future trial enrollment, completion, and generalizability. Standardized reporting using CONSORT in clinical trials involving SAH patients is strongly recommended.

This study aimed to assess whether brief stop-smoking advice given to women who smoke and visit their general practice for cervical cancer screening improves smoking cessation outcomes.

This two-arm cluster-randomized controlled trial was conducted in 75 Dutch general practices. Participants in the intervention group received brief stop-smoking advice based on the Ask-Advise-Connect method, delivered by a practice assistant. Patient-reported outcomes were measured at 6 months: undertaking a serious quit attempt of at least 24 hours during follow-up (primary outcome), 7-day point prevalence abstinence at 6 months, reduction in number of cigarettes smoked, increase in motivation to quit smoking, exposure to advice or support, and other psychological and behavioral measurements.

There was no significant difference in undertaking a serious quit attempt between the intervention (39.8% of n = 266) and control group (36.0% of n = 214), odds ratio 1.18 (95% confidence intervals: 0.80-1.72, p = .41). Neither did the point prevalence abstinence significantly differ between groups: 21.1% versus 16.3%, odds ratio 1.38 (95% confidence interval: 0.83-2.29, p = .21). Although nonsignificant, the direction of effects for the aforementioned outcomes was in favor of the intervention group. The reduction in the number of cigarettes smoked and increase in motivation to quit did not differ between groups. The uptake of cessation counseling was higher in the intervention (14.7%) than in the control group (2.8%).

A brief stop-smoking strategy after the smear test for cervical screening might encourage women who smoke to attempt quitting and seek cessation counseling, but a significant effect could not be demonstrated in this trial.

The results of this cluster-randomized trial suggest that brief advice to stop-smoking delivered by a practice assistant after routine cervical screening in general practice might encourage women who smoke to attempt quitting, but a significant effect could not be proven. Also, women who receive advice show a higher uptake of professional cessation counseling compared to their controls. Providing brief advice after the cervical smear might therefore be a useful opportunistic approach to stimulate cessation in women who smoke.

To explore secondary outcomes at endpoint comparing treatments with adequate self-mediated physical activity combined with either night-time brace (NB), scoliosis-specific exercise (SSE), or adequate self-mediated physical activity alone (PA) in Adolescent Idiopathic Scoliosis (AIS).

A longitudinal, prospective, multicenter RCT was conducted including 135 girls/boys, Cobb angle 25-40°, 9-17 years, and ≥1-year remaining growth were randomly allocated into NB, SSE, or PA group. Endpoint was curve progression of ≤6° (success) at skeletal maturity or >6° (failure). Outcomes included angle of trunk rotation (ATR), major curve Cobb angle, Spinal Appearance Questionnaire (pSAQ), Scoliosis Research Society-22r (SRS-22r), EQ-5Dimensions Youth 3Levels (EQ-5D-Y-3L), and EQ-Visual-Analogue-Scale (EQ-VAS), adherence to treatment and International Physical Activity Questionnaire (IPAQ-SF).

At endpoint, 122 patients were analyzed per protocol, mean age 12.7 (±1.4) years, and mean Cobb angle 31° (±4.3). A significant difference in change for ATR favored NB group compared to SSE group -2.0º (95% CI -3.7 to -0.3). EQ-5D-Y-3L dimensions showed a significant difference in change with decrease in mobility (p=0.031), and usual activities (p=0.003) for SSE compared to NB and PA groups. Treatment adherence was adequate but slightly better in NB and PA groups compared to SSE on self-report (p=0.012), and health care provider (HCP) report was better in PA compared to SSE group (p=0.013). Higher motivation and capability explained 53% of the variability and gave better odds for higher adherence (OR = 11.12, 95% CI = 1.5 to 34.4; OR = 7.23, 95% CI = 2.9 to 43.3), respectively.

Night-time brace, scoliosis-specific exercise or physical activity interventions for adolescents with idiopathic scoliosis showed small differences between groups in trunk rotation, spinal deformity and appearance, health-related quality of life, and treatment adherence but not likely reaching clinical relevance.

Integrated care models enhanced by the clinical decision support system offer innovative approaches to managing the growing global burden of older adult care. However, their efficacy remains uncertain.

This study aimed to evaluate the efficacy of an intelligent and integrated older adult care model, termed the SMART (Sensors and scales [receptor], a Mobile phone autonomous response system [central nervous system in the spinal cord], a Remote cloud management center [central nervous system in the brain], and a Total care system [effector]) system, in improving the quality of life (QOL) for home-dwelling older adults.

In this stratified randomized controlled trial, we consecutively recruited older adults aged 65 years or older from November 1, 2020, to December 31, 2020. Eligible participants were randomly allocated 1:1 to either the SMART group, receiving routine discharge instructions and personalized integrated care interventions across 11 domains (decreased or lost self-care ability, falls, delirium, dysphagia, incontinence, constipation, urinary retention, cognitive decline, depression, impaired skin integrity, and common diseases) generated by the SMART system, or the usual care group, receiving only routine discharge instructions. The intervention lasted for 3 months. The primary end point was the percent change in QOL from baseline to the 3-month follow-up, assessed using the World Health Organization Quality of Life Instrument - Older Adults Module. Secondary end points included functional status at the 3-month follow-up and percent changes in health self-management ability, social support, and confidence in avoiding falling from baseline to the 3-month follow-up. Data were analyzed following the intention-to-treat principle, using covariance or logistic regression models, as appropriate. Subgroup and sensitivity analyses were conducted to assess result consistency and robustness.

In total, 94 participants were recruited, with 48 assigned to the SMART group. The personalized and integrated care by the SMART system significantly improved the QOL among the older adults, with an estimated intervention difference of 11.97% (95% CI 7.2%-16.74%, P<.001), and social support and health self-management ability as well, with estimated intervention differences of 6.75% (95% CI 3.19%-10.3%, P<.001) and 4.95% (95% CI 0.11%-10%, P=.003), respectively, while insignificantly improving in the Modified Falls Efficacy Scale score. Similarly, the SMART system had a 66% reduction in instrumental activities of daily living disability (odds ratio [OR] 0.34, 95% CI 0.11-0.83, P=.02). However, the SMART system did not significantly affect activities of daily living disability or the Modified Falls Efficacy Scale score. The subgroup and sensitivity analyses confirmed the robustness of the findings.

The personalized and integrated older adult care by the SMART system demonstrated significant efficacy in improving QOL, health self-management ability, and social support, while reducing instrumental activities of daily living disability among home-dwelling older adults.

Chinese Clinical Trial Registry ChiCTR-IOR-17010368; https://tinyurl.com/2zax24xr.

Evaluate a knee/hip osteoarthritis eLearning course for patients.

Randomised controlled trial. 124 community volunteers with knee/hip osteoarthritis were randomised to either i) a 4-week self-directed eLearning or ii) an electronic osteoarthritis pamphlet (control).

change in knowledge (Osteoarthritis Knowledge Scale (OAKS)) and pain self-efficacy (Arthritis Self-Efficacy Scale (ASES pain subscale)) over 5 weeks.

fear of movement, exercise self-efficacy, osteoarthritis illness perceptions, physical activity levels, and use of physical activity/exercise, weight loss, pain medication, and health professional care seeking to manage joint symptoms.

117(94 %) participants (mean (SD) age, 67.1(8.8) years; 91(77.8 %) female) provided 5-week primary outcomes. At 5-weeks, eLearning group showed greater improvements in osteoarthritis knowledge (mean difference 5.3(95 % CI 2.5,8.2), < 0.001), which was sustained at 13-weeks (4.6(2.1,7.0), < 0.001). There were no between-group differences in pain self-efficacy. Between-group differences for exercise self-efficacy and osteoarthritis illness perceptions at 5-weeks, and fear of movement and use of weight loss to manage joint symptoms at 13-weeks, favoured eLearning group.

eLearning produced immediate and sustained improvements in osteoarthritis knowledge but not pain self-efficacy compared to a typical osteoarthritis education intervention (information pamphlet).

Self-directed interactive eLearning is an effective method to educate patients about hip/knee osteoarthritis and its management.

In recent years, the prevalence of cardiometabolic disease (CMD) in African American women has risen; the risk also increases with age, in comparison to men. Evidence demonstrates that stressful life events, including experiences of racism and perceived discrimination, contribute substantially to inflammatory diseases, such as CMD. Despite this evidence, few evidence-based interventions are available to assist individuals from minoritized communities in coping with the chronic stress related to their racial or ethnic identity.

Our proposed randomized controlled trial will test a novel, race-based intervention tailored to African American women, called Resilience, Stress, and Ethnicity (RiSE).

In this randomized controlled trial, we will randomize participants 1:1 to the 8-week, group-based RiSE program (intervention) or a health education program (active control group). Both programs will consist of synchronous classes on Zoom and will be led by experts. The primary end point will be stress at 6 months after the intervention, and the efficacy of RiSE will be evaluated for improving stress-related symptoms (current perceived stress, depressive symptoms, fatigue, and sleep disturbance), improving coping strategies, and reducing inflammatory burden in African American women at risk for CMD. Validated survey measures and inflammatory biomarkers will be assessed at baseline, midintervention, intervention completion, and 6 months after the intervention, and differences over time by intervention will be evaluated using mixed effects models.

This study was funded by the National Institute on Aging on March 30, 2023, with recruitment and enrollment beginning in October 2023. The study is underway, with 120 participants enrolled as of March 2025.

This study will be one of the first to examine a race-based stress reduction intervention in African American women and has the potential to improve the health of minoritized groups faced with chronic stress associated with experiencing racism and discrimination. We anticipate that RiSE will reduce stress-related symptoms, enhance adaptive coping, and reduce inflammation.

ClinicalTrials.gov NCT05902741; https://www.clinicaltrials.gov/study/NCT05902741.

Study DesignCross sectional.ObjectiveSpin bias, where authors distort findings to overstate efficacy, is prevalent in the medical literature. The comparative superiority of polyetheretherketone (PEEK) and titanium (Ti) cages in spinal fusion remains controversial. This study aims to assess the prevalence of spin bias in meta-analyses and systematic reviews comparing PEEK vs Ti cages in spinal fusion.MethodsThe PubMed, Embase, and Web of Science databases were searched to identify meta-analyses and systematic reviews comparing PEEK and titanium cages in spinal fusion. Included studies were assessed for the presence of the 9 most severe types of spin bias. This study also graded the quality of these articles using A Measurement Tool to Assess systematic Reviews 2 (AMSTAR 2) criteria.ResultsThe search resulted in 2352 articles, of which 13 met the inclusion criteria. Spin bias was identified in 8/13 (61.54%) of the included studies, with the most prevalent types being Type 3 (38.46%) and Type 5 (30.77%). Using AMSTAR 2, 1/13 (7.69%) studies were rated as critically low quality, 4/13 (30.77%) as low, 8/13 (61.54%) as moderate, with none rated as high.ConclusionsSpin was found in 61.54% of the reviews comparing PEEK and Ti cages in spinal fusion, with none achieving a high-quality rating. Surgeons must critically evaluate these articles for bias prior to utilizing them in clinical decision making.

Many people with schizophrenia do not respond to an initially prescribed antipsychotic drug. In such cases, one treatment strategy could be to switch to a different antipsychotic drug.

To examine the effects of switching antipsychotic drugs in treating people with schizophrenia who have not responded to initial antipsychotic treatment.

We searched the Cochrane Schizophrenia Group Trials Register (to December 2022). We inspected the references of all included studies for further relevant trials.

We included all relevant randomised controlled trials (RCTs) comparing switching to a different antipsychotic drug rather than continuing treatment with the same antipsychotic drug for people with schizophrenia who did not respond to their initial antipsychotic treatment.

At least two review authors independently extracted data. The primary outcomes were: clinically relevant response as defined by study authors; tolerability (participants leaving the study early due to adverse effects); and quality of life assessed by the change score in the 36-Item Short Form survey. We analysed dichotomous data using the risk ratio (RR) and its 95% confidence interval (CI). We analysed continuous data using mean differences (MD) and corresponding 95% CI. We assessed the risk of bias of the included studies and used GRADE to evaluate the certainty of evidence for the following outcomes: clinically relevant response, tolerability (leaving the study early due to adverse effects), quality of life score change, acceptability (leaving the study early for any reason), general mental state (average change in general mental state scores), duration of hospitalisation, and number of participants experiencing at least one adverse effect.

We included 10 RCTs with 997 participants in the review. Nine studies used a parallel design, and one used a cross-over design. Seven studies were double-blind, two were single-blind and one did not provide any detail regarding blinding. All studies included people who were non-responsive to ongoing antipsychotic treatment. The minimum duration of the ongoing antipsychotic treatment ranged from three days to two years. The length of the comparison phase varied from two weeks to six months. The studies were published between 1993 and 2022. In about half of the studies, the methods of randomisation, allocation and blinding were poorly reported. The evidence is very uncertain regarding the effect of switching antipsychotics on clinically relevant response (RR 1.25, 95% CI 0.77 to 2.03; I² = 43%; 7 studies, 693 participants), quality of life (MD -1.30, 95% CI -3.44 to 0.84; 1 study, 188 participants), Positive and Negative Syndrome Scale (PANSS) score change (MD -0.92, 95% CI -4.69 to 2.86; I² = 47%; 6 studies, 777 participants), duration of hospitalisation (in days) (MD 9.19, 95% CI -8.93 to 27.31; I² = 0%; 2 studies, 34 participants) and the number of people experiencing at least one adverse effect (RR 1.29, 95% CI 0.81 to 2.05; I² = 36%; 3 studies, 412 participants). Compared to continuing current treatment, switching antipsychotics may result in little to no difference in tolerability, defined as the number of participants leaving the study early due to adverse effects (RR 0.73, 95% CI 0.24 to 2.26; I² = 31%; 6 studies, 672 participants; low-certainty evidence) and leaving the study early for any reason (RR 0.91, 95% CI 0.71 to 1.17; I² = 0%; 6 studies, 672 participants; low-certainty evidence).

This review synthesises currently available RCT evidence on switching antipsychotics versus continuing the same antipsychotic in individuals with schizophrenia who did not respond to their initial treatment. Overall, the evidence remains highly uncertain regarding the effects of either strategy on efficacy and safety outcomes, and no definitive recommendations can currently be made. There is an urgent need for larger, well-designed trials to identify the optimal treatment strategy for these cases.

Amongst the main perspectives when evaluating the results of medical studies are statistical significance (following formal statistical testing) and clinical significance. While statistical significance shows that a factor's observed effect on the study results is unlikely (for a given alpha) to be due to chance, effect size shows that the factor's effect is substantial enough to be clinically useful. The essence of statistical significance is "negative" - that the effect of a factor under study probably did not happen by chance. In contrast, effect size and clinical significance evaluate whether a clinically "positive" effect of a factor is effective and cost-effective. Medical diagnoses and treatments should never be based on the results of a single study. Results from numerous well-designed studies performed in different circumstances are needed, focusing on the magnitude of the effects observed and their relevance to the medical matters being studied rather than on the p-values. This paper discusses statistical inference and its relevance to clinical importance of quantitative testing in clinical laboratories. To achieve this, we first pose questions focusing on fundamental statistical concepts and their relationship to clinical significance. The paper also aims to provide examples of using the methodological approaches of superiority, equivalence, non-inferiority, and inferiority studies in clinical laboratories, which can be used in evidence-based decision-making processes for laboratory professionals.

Fixed orthodontic appliances facilitate microbial adhesion and plaque accumulation. Although chlorhexidine has proven to be the most effective antiplaque and antigingivitis agent, it has several side effects.

The present study aims to evaluate and compare the effectiveness of silver nanoparticles (SNP) and Chlorhexidine (CHX) mouthwash on reducing the microbial count and improving oral health during fixed orthodontic treatment.

4-arm parallel, placebo-controlled, double-blind randomized clinical trial with an allocation ratio of 1:1:1:1.

Microbial count of Streptococcus spp., Plaque Index, Gingival Index, Gingival Bleeding Index and Pocket Probing Depth were evaluated in 80 orthodontic patients at T0 (Pretreatment), T1 (four weeks after bonding) and T2 (four weeks after mouthwash prescription). Then patients were randomized into four groups: G1) NanOlife (containing SNP), G2) Chlorhex (containing 0.2% chlorhexidine), G3) Placebo, and G4) negative control (no mouthwash prescription) (n=20 each group). The effects of orthodontic treatment and mouthwashes were analyzed statistically.

The microbial count and all the four indices increased between T0 and T1 (P<0.05). They decreased below the baseline levels in Gp2, and back to baseline levels in Gp1 at T2 (P<0.05), except Gingival Bleeding index and Pocket Probing Depth. Both mouthwashes showed significantly improved therapeutic effects compared to placebo and negative control.

Although SNP mouthwash was effective in the reduction of all the assessed parameters, it could not decrease them to the baseline levels, suggesting its limited efficacy. CHX mouthwash proved to be extremely effective by decreasing the microbial count, plaque index and gingival index below the baseline level.

To compare the keep moving together (KMT) protocol between telerehabilitation (Tele KMT) or face-to-face (Face KMT).

A randomized controlled clinical trial, including a goal-oriented training program for gross motor function activities for children/adolescents with cerebral palsy. One group will have supervised sessions with a physical therapist through telerehabilitation while the other will have face-to-face sessions. Both groups will receive sessions supervised only by a caregiver 3 times per week, at home. The KMT protocol is for 12 weeks. The primary outcome will be gross motor function using the Gross Motor Function Measure. Secondary outcomes are mobility, goals achieved, participation, caregivers' satisfaction, and adverse events. Impact statement: If effective, the Tele-KMT may be an alternative when face-to-face interventions are not possible.

Learning basic laparoscopic skills can be efficiently performed ex vivo in a safe environment using simulation devices. However, in many countries, the broad and mandatory implementation of ex vivo laparoscopic simulation training in surgical residency is still lacking. The aim of the study was to evaluate the efficacy of laparoscopic basic skills simulation training on the surgical performance of residents during their first laparoscopic procedures in the operating room.

This was a multicenter, prospective, randomized, two-arm, single-blind trial. The study recruited first-year surgical residents (NOVICE) with no previous personal experience in laparoscopic surgery. After the participants had performed their first laparoscopic cholecystectomy, they were randomized into two groups: the intervention group underwent six weeks of standardized laparoscopic basic skills simulation training (Lübeck Toolbox Curriculum), whereas the control group did not. After six weeks, both groups performed a second cholecystectomy. The videotapes of the first and second cholecystectomies were evaluated blinded based on the Global Operative Assessment of Laparoscopic Skill (GOALS) score. The primary endpoint was the changes in the GOALS scores between the first and second cholecystectomies.

22 surgical residents from 11 surgical clinics in Germany were included, and 4 residents dropped out. The median improvement in the LTB-Curriculum group between CHE I and CHE II was 8.5 GOALS score points in contrast to 2 points in the control group. This difference was statistically significant (95%CI: 1-15 points, P = 0.013).

Ex-vivo training in basic laparoscopic skills significantly improved the surgical performance of residents during their first laparoscopic cholecystectomies in the operating room.

Physical activity (PA) is critical for healthy development in preschoolers, with long-lasting benefits that can affect later life. The World Health Organization (WHO) recommends that children aged 5-17 years should engage in 60 min of moderate-to-vigorous PA per day. However, physical inactivity in children is on the rise globally, with declines in PA starting at the age of 4 years. Increasing PA during early childhood is important to delay adiposity rebound, promote behavioral changes, improve physical fitness, and facilitate future PA engagement. However, limited evidence has been established on the effects of school-based PA interventions on preschoolers. This study examines the effects and sustainability of a preschool-based PA intervention on increasing PA, improving physical fitness and health in preschoolers, with the exercise dose benchmarked to the WHO PA guidelines.

This assessor-blinded, two-arm cluster randomized controlled trial will include 3300 preschoolers (aged 5-6 years) from 110 kindergartens in Hong Kong, China. Kindergartens will be randomized into intervention and control groups in a 1:1 ratio. The control kindergartens will continue their usual curriculum of ∼2.5 h PA/week, whereas preschoolers in the intervention kindergartens will engage in an additional 75-min game-based PA class twice per week (extra 2.5 h PA/week) over the preschool year. This multi-component intervention will also target parents, teachers, and the kindergarten environment to further encourage PA in preschoolers and their families. Objectively measured PA, cardiorespiratory fitness and other physical fitness components (muscle strength and power, agility, balance, flexibility, body composition), and psychological health will be examined at the start (0 month) and end (10 months) of the preschool year. Maintenance effects will be assessed after preschoolers' transition into primary school (16 months). Generalized estimating equations or other appropriate statistical models will be used to examine the treatment effects with adjustment for baseline values.

This study will investigate the effects of a preschool-based PA intervention with PA dose benchmarked to the WHO recommendations on promoting PA, physical fitness, and health in preschoolers, and its sustainability after preschoolers' transition into primary education. The findings will raise public awareness on the importance of PA in young children, and will inform policy making to facilitate early childhood educational reforms to incorporate adequate PA into preschool curriculums to improve children's health in the long run.

ClinicalTrials.gov (NCT05521490).

Physiotherapists play a crucial role in managing patients with musculoskeletal pain. However, their training often lacks focus on pain management.

This randomized controlled trial evaluated the effects of two e-learning programs on physiotherapists' knowledge, attitudes, and confidence in musculoskeletal pain management.

Eligible participants had active professional registration, treated patients with musculoskeletal pain, and had internet access. Participants were randomized into two groups (video-based and booklet-based), with interventions lasting 5 weeks. Assessments were conducted at baseline, 6 weeks (T1), and 12 weeks (T2) using the Neurophysiology of Pain Questionnaire, a pain attitude survey, and self-reported confidence.

A total of 211 physiotherapists were randomized (video = 106; booklet = 105). Both groups improved pain neurophysiology knowledge, with the booklet group scoring higher at T1 (adjusted mean difference = 1.25, 95%CI = 0.93 to 1.58) and T2 (adjusted mean difference = 1.30, 95%CI = 0.97 to 1.63). Attitudes varied: the booklet group improved in emotion (adjusted mean difference = -0.19, 95%CI = -0.35 to -0.03) and control (adjusted mean difference = -0.20, 95%CI = -0.37 to -0.03) at T2, while the video group improved in solicitude (adjusted mean difference = -0.37, 95% CI: 0.55 to -0.19) and disability at T1 and T2. No significant effects were found in the medical cure domain, and no interaction effects were observed in the physical harm domain. Confidence increased in both groups, with no between-group differences.

Both e-learning programs effectively enhanced physiotherapists' knowledge, attitudes, and confidence in musculoskeletal pain management, demonstrating the value of e-learning for continuing education.

Various acupuncture techniques are widely applied in clinics for pain control and dysfunction relief in patients with knee osteoarthritis (KOA). The purpose of this trial was to investigate whether the different acupuncture techniques were more effective in treating joint pain and dysfunction than were sham acupuncture or drug treatment in patients with KOA and to determine the differences in efficacy among them.

In this multi-center, single-blind, randomized, controlled trial, participants were randomly assigned to the manual acupuncture (MA), electroacupuncture (EA), warm-needling acupuncture (WA), mild moxibustion (MM), sham acupuncture (SA), or drug treatment (Celebrex) groups. Each participant in the above groups received individual treatments for 4 consecutive weeks. The primary outcome measures included the visual analog scale score (VAS) and the physical function score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Compared with the SA group, the acupuncture technique groups (MA, EA, WA, and MM) had markedly lower patient VAS scores (- 0.61; 95% CI - 1.09 to - 0.13; P = 0.01) and lower WOMAC physical function scores (- 13.84; 95% CI - 21.14 to - 6.54; P < 0.01). Compared with Celebrex, EA had a significant advantage in reducing the VAS score (1.14; 95% CI 0.55 to 1.72; P < 0.01) and WOMAC physical function score (14.81; 95% CI 5.69 to 23.93; P < 0.01).

The observed acupuncture techniques effectively relieve pain and ameliorate knee joint dysfunction in patients with KOA. EA is the most effective method of alleviating pain intensity in treating KOA.

The trial was registered on ClinicalTrials.gov (NCT03563690).

Despite advances in research on training and nutritional supplementation, it is largely unknown how micronutrient intake modulates the response to training in older adults. This study investigates the relationship between nutrient intake and response to training in older women at risk of sarcopenia.

A randomized clinical trial with two parallel groups (high-speed resistance training (H-RT) and multicomponent training (MT)) was conducted over a 32-week intervention involving 80 older women at risk of sarcopenia (mean age: 77.36 ± 6.71 years). A food frequency questionnaire was administered to assess whether nutrient intake influenced strength outcomes measured by the Five Times Sit-to-Stand Test (5STS) and other functional variables.

Significant improvements in the five times sit to stand test (5STS) were observed in both groups post-intervention (p < 0.001), with no significant differences between them (p = 0.127), suggesting comparable effectiveness. In both groups, lower levels of vitamin B12 (H-RT: rp = -0.52; MT: rp = -0.50) and vitamin D (H-RT: rp = -0.55; MT: rp = -0.69) were associated with worse 5STS performance. Additionally, in the H-RT group, lower levels of vitamin E (rp = -0.36), magnesium (rp = -0.48), iron (rp = -0.43), and potassium (rp = -0.47) were also correlated with poorer performance.

The results indicate that improvements in strength are related to micronutrient sufficiency rather than macronutrient sufficiency. Deficiencies in vitamin D and B12 negatively impacted muscle strength gains in both H-RT and MT, while vitamin E, potassium, magnesium, and iron influenced H-RT outcomes. The lesser effect of micronutrient deficiencies on MT suggests it may be more suitable for individuals with mild deficiencies, as it requires fewer specific nutrients for muscle strength.

The study is registered at ClinicalTrials.gov under the identifier NCT05870046.

Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery.

The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021.

For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95% HR-CI, 0.809-1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95% HR-CI, 0.817-1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95% HR-CI, 0.932-2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45).

Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.