Randomized Trial Research Articles

My virtual escape from patient life: a feasibility study on the experiences and benefits of individualized virtual reality for inpatients in palliative cancer care

BackgroundCancer patients benefit from Virtual Reality (VR) in burdensome situations, but evidence is scarce for palliative situations. Based on earlier work in palliative care, individualized VR interventions like seeing the patient’s home may address a patient’s wish to be at home and thus have a greater effect compared to standard VR content. Yet, some patients and relatives may be concerned about their privacy. Also, patient stakeholders raised concerns about triggering depressed mood or homesickness.AimTo test the feasibility and safety of individualized vs. standard 360°video VR interventions in palliative cancer inpatients.MethodsProspective observational study with patient-reported outcome measurement using validated instruments of well-being (MDBF), symptoms and psychosocial burden (IPOS), cybersickness (SSQ), presence experience (SPES), subjective benefit (2 items), content analysis of interviews, and field notes. Individualized VR content was recorded with action camcorder-technology to protect the patients’ privacy.ResultsSeventeen patients participated, median age 65 years (range 20–82), 9 women (53%), 8 single or widowed (47%), 4 childless (23.5%), 4 academics (23.5%), with a median length of stay of 9 days (1–75) in the hematology (10), palliative care (3), or radiotherapy (2) unit of a German university hospital. Eight patients (53.3%) chose their own home environments or family for individualized VR-content. All participants enjoyed the intervention. Compared to standard VR content the individualized VR tended to have a stronger effect on well-being and emotional touch. It was not inferior in terms of psychosocial burden and cybersickness. No subjective and relevant side effects occurred. The patients well tolerated the assessments. However, most patients demanded a lighter headset and a desire for more interactivity.ConclusionsIndividualization of VR content shows potential for enhancement of immersion, which improves the VR experience and does not harm in terms of depressed mood or worsening of symptoms. The patients’ and family desire for privacy is feasible with the support of family members who recorded the individualized videos, which is easily manageable today. We suggest a pragmatic randomized clinical trial to compare the effects of individualized vs. standard VR-content.Trial registrationRegistered at German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS); registration number: DRKS00032172; registration date: 11/07/2023.

Sample Size Planning in the Design of Two-Level Randomized Cost-Effectiveness Trials

This study introduces recent advances in statistical power analysis methods and tools for designing and analyzing randomized cost-effectiveness trials (RCETs) to evaluate the causal effects and costs of social work interventions. The article focuses on two-level designs, where, for example, students are nested within schools, with interventions applied either at the school level (cluster design) or student level (multisite design). We explore three statistical modeling strategies—random-effects, constant-effects, and fixed-effects models—to assess the cost-effectiveness of interventions, and we develop corresponding power analysis methods and tools. Power is influenced by effect size, sample sizes, and design parameters. We developed a user-friendly tool, PowerUp!-CEA, to aid researchers in planning RCETs. When designing RCETs, it is crucial to consider cost variance, its nested effects, and the covariance between effectiveness and cost data, as neglecting these factors may lead to underestimated power.

The efficacy and safety of per-nasal "GTS partner" assisted traction technique for gastric endoscopic submucosal dissection: a prospective single-center randomized clinical trial.

Since the snare traction-assisted ESD has been proven effective in treating flat lesions of the digestive tract, we modified and innovated the process and path of the traditional snare entering the digestive tract, aiming to investigate the efficacy and safety of using the per-nasal "GTS partner" assisted traction technology in gastric ESD. Patients with superficial gastric neoplasms were prospectively enrolled between November 2022 and May 2024 and randomly assigned to a conventional ESD (C-ESD) group or per-nasal "GTS partner" traction-assisted ESD (GTS-ESD) group. The primary outcomes were procedure time and dissection speed. The GTS-ESD and C-ESD groups included 40 patients each, and all the enrolled patients underwent the assigned treatment. The median procedure time in the GTS-ESD group was shorter than that in the C-ESD group (38min vs. 48min; P < 0.001), and the mean resection speed of the GTS-ESD group was faster than that of the C-ESD group (17.95 mm2/min vs. 11.86 mm2/min; P = 0.033). The median resection speed of lesions ≥ 20mm was faster by GTS-ESD than by C-ESD (21.21 mm2/min vs. 12.83 mm2/min, P = 0.002). The en bloc resection rate (100% vs 100%) and R0 resection rate (100% vs. 97.5%) were similar between the two groups. There were no adverse events related to the per-nasal "GTS partner" assisted traction technology, and the traction technology had little interference with the endoscopist. The per-nasal "GTS partner" assisted traction technique can significantly shorten the gastric ESD procedure time and has the advantages of no damage to normal mucosa and adjustable traction direction, especially in the lower 1/3 of the stomach or lesions with a diameter of ≥ 20mm.

Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial

ObjectivesTo compare pulpal survival and treatment needs following selective and total caries removal in mature permanent teeth. MethodsThe design was a parallel double blind, randomized clinical trial. Mature teeth with caries radiographically extending ≥ 2/3 of dentine and without spontaneous pulpitis were included. Teeth were allocated to either selective (SCR) or total caries removal (TCR) using block randomization technique. In the SCR group, caries removal to firm dentine was followed by placement of Biodentine and composite restoration. In TCR group caries removal was to hard dentine; with immediate management by vital pulp therapy (VPT) using Biodentine in case of pulp exposure. Preoperative pain levels were recorded. Teeth were followed up after 6 and 12 months. Data were analyzed using Chi square test and regression analysis. Results124 teeth with a diagnosis of reversible pulpitis were treated (63 in SCR, 61 in TCR). 17/ 61 teeth (28%) in the TCR had pulp exposure, managed by VPT and were successful at recall. Pulp survival was significantly higher in TCR compared to SCR at 6 months (100 % vs 93.65%, p =0.04 respectively) and at 12 months (98.4% vs 82.5, P= 0.003 respectively). Multivariate analysis revealed the type of procedure (SCR vs TCR) and the preoperative pain levels (above or below 5/10) as significant prognostic factors. The odds of failure increased significantly for teeth treated with SCR (OR 27.6, 3.6–212.4, p=0.001) and if preoperative pain levels were ≥5/10 (OR 0.2, 0.04-0.8, P=0.024). ConclusionSelective caries removal for deep carious lesions in mature teeth failed to reveal overt pulp exposures in more than one quarter of cases and led to significantly lower pulp survival over one year, when compared with complete caries removal and immediate VPT. Clinical significanceIn deep carious lesions of mature permeant teeth with revrsible pulpitis, total caries removal to hard dentine is recommended for a predictable pulp survival. Clinical trial registrationThis trial was registered at CliniclTrials.gov (NCT05144711).

The application of Bayesian method in estimating heterogeneity of treatment effect

It is well recognized that the benefit of medical interventions may not be distributed evenly in the target population due to patient heterogeneity, and conclusions based on traditional randomized clinical trials do not apply to everyone. Considering the increasing cost of randomized trials and difficulties in recruiting patients, there is an urgent need to develop analytical methods to estimate treatment effects in subgroups. In particular, due to limited sample sizes of subgroups, standard analysis tends to yield wide confidence intervals for the treatment effect, which are often uninformative. In this article, the superiority of the empirical Bayes estimate of the conditional average treatment effect is demonstrated by using a linear regression model to specifically represent treatment-covariate interactions. To obtain more accurate prior distributions and posterior estimates of treatment effects in subgroups, we utilize the covariate-dependent precision parameter across subgroups. Based on subgroup data obtained from clinical trials, the covariate-dependent precision parameter is used to assess the similarity of treatment effects across subgroups, which is an approach to obtain more reasonable prior information. To verify the validity of the empirical Bayes method, we evaluate it by a real clinical trial comparing insulin and metformin.

A Comparison of Sodium Citrate and Sodium Bicarbonate's Safety and Effectiveness in Treating Metabolic Acidosis in Patients with Chronic Renal Disease

Background: Metabolic acidosis is a common complication in patients with chronic kidney disease (CKD) that accelerates disease progression and worsens overall health outcomes. Objective: This study compares the safety and effectiveness of sodium citrate and sodium bicarbonate in treating metabolic acidosis in CKD patients to determine the optimal therapeutic approach. Method: A prospective randomized clinical trial was conducted at the Department of Anesthesiology and ICU, Shaheed Monsur Ali Medical College and Hospital, Dhaka, Bangladesh, from October 2023 to September 2024. A total of 132 CKD patients with metabolic acidosis were randomly assigned to two groups: Group A (66 patients) received sodium citrate, and Group B (66 patients) received sodium bicarbonate. Safety, efficacy, and acid-base balance were monitored over 12 months. Results: Both sodium citrate and sodium bicarbonate significantly improved serum bicarbonate levels and reduced blood acidity. In Group A, 85% of patients showed a 50% reduction in acidemia, compared to 78% in Group B. However, Group A demonstrated superior gastrointestinal tolerance (10% side effects) compared to Group B (25% side effects). Sodium citrate also improved bone health markers, with a 15% improvement in calcium levels, while sodium bicarbonate patients had a 10% increase. However, sodium bicarbonate was more cost-effective. Conclusions: Sodium citrate appears to be more effective and better tolerated than sodium bicarbonate in treating metabolic acidosis in CKD patients, though cost considerations may influence therapeutic choices.

The potential cutaneous benefits of bentonites and montmorillonites.

Bentonites and montmorillonites, natural clay minerals originating from volcanic ash, possess unique properties that have traditionally been utilized in industrial applications. Recently, their potential biomedical applications, particularly in dermatology, have garnered significant interest. This review explores the cutaneous benefits of bentonites and montmorillonites, highlighting their anti-inflammatory, wound-healing, oil-absorbing, drug delivery, photoprotective, and anti-aging effects. Evidence from in vitro experiments, animal studies, and preliminary clinical trials demonstrate that these clays can significantly reduce inflammation, accelerate wound healing, absorb excess oil, enhance drug delivery, protect against ultraviolet radiation, and improve skin hydration and elasticity. Larger scale randomized clinical trials (RCTs) are needed to further establish the safety and efficacy of bentonites and montmorillonites. Given the increasing consumer demand for natural ingredients in skincare, bentonites and montmorillonites present a promising area for further research and development in dermatologic applications.

Effects of healthy low-carbohydrate diet and time-restricted eating on weight and gut microbiome in adults with overweight or obesity: Feeding RCT.

The effect of a healthy low-carbohydrate diet (HLCD) and time-restricted eating (TRE), alone or in combination, on body weight and gut microbiome beyond caloric restriction remains unclear. In this 12-week two-by-two factorial randomized trial with a 28-week follow-up among 96 participants with overweight or obesity, isocaloric-restricted feeding yields significant weight loss, ranging from 2.57 to 4.11kg across different groups. Beyond caloric restriction, HLCD and TRE lead to additional reduction in body mass index. HLCD results in additional fat mass loss while TRE yields more lean mass loss. Additionally, HLCD leads to decreased fecal branched-chain amino acids, and TRE tends to yield an increased abundance of probiotic species involved in synthesizing short-chain fatty acids. Moreover, the effect of HLCD on reducing fat mass is sustained during the post-intervention follow-up. Overall, HLCD and TRE are effective in weight management and yield profound gut microbiome and metabolome alteration beyond caloric restriction. This study was registered at ChiCTR.org.cn (ChiCTR2200056363).

Retraction Note: To do or not to do emergency cervical cerclage (a rescue stitch) at 24-28 weeks gestation in addition to progesterone for patients coming early in labor? A prospective randomized trial for efficacy and safety.

Retraction Note: To do or not to do emergency cervical cerclage (a rescue stitch) at 24-28 weeks gestation in addition to progesterone for patients coming early in labor? A prospective randomized trial for efficacy and safety.

Safety of single-dose bedaquiline combined with rifampicin for leprosy post-exposure prophylaxis: A Phase 2 randomized non-inferiority trial in the Comoros Islands.

To reduce leprosy risk in contacts of patients with leprosy by around 50%, the World Health Organization (WHO) recommends leprosy post-exposure prophylaxis (PEP) using single-dose rifampicin (SDR). Results from a cluster randomized trial in the Comoros and Madagascar suggest that PEP with a double dose of rifampicin led to a similar reduction in incident leprosy, prompting the need for stronger PEP. The objective of this Phase 2 trial was to assess safety of a bedaquiline-enhanced PEP regimen (intervention arm, bedaquiline 800 mg with rifampicin 600 mg, BE-PEP), relative to the WHO recommended PEP with rifampicin 600 mg alone (control arm, SDR-PEP). From July 2022 to January 2023, consenting participants were screened for eligibility, including a heart rate-corrected QT interval (QTc) <450 ms and liver enzyme tests (ALT/AST) below 3× the upper limit of normal (ULN), before they were individually randomized 1:1 in an open-label design. Recruitment was sequential, by age group. Pediatric dosages were weight adjusted. Follow-up was done at day 1 post-dose (including ECG) and day 14 (including ALT/AST), with repeat of ALT/AST on the last follow-up at day 30 in case of elevation on day 14. The primary outcome was non-inferiority of BE-PEP based on a <10 ms difference in QTc 24 h after treatment administration, both unadjusted and adjusted for baseline QTc. Of 408 screened participants, 313 were enrolled, starting with 187 adults, then 38 children aged 13 to 17 years, and finally 88 children aged 5 to 12 years, of whom 310 (99%) completed all visits. Across all ages, the mean QTc change on BE-PEP was from 393 ms to 396 ms, not significantly different from the change from 392 ms to 394 ms on SDR-PEP (difference between arms 1.8 ms, 95% CI -1.8, 5.3, p = 0.41). No individual's QTc increased by >50 ms or exceeded 450 ms after PEP administration. Per protocol, all children were analyzed together, with no significant difference in mean QTc increase for BE-PEP compared to SDR-PEP, although non-inferiority of BE-PEP in children was not demonstrated in unadjusted analysis, as the upper limit of the 95% CI of 10.4 ms exceeded the predefined margin of 10 ms. Adjusting for baseline QTc, the regression coefficient and 95% CI (3.3; -1.4, 8.0) met the 10 ms non-inferiority margin. No significant differences in ALT or AST levels were noted between the intervention and control arms, although a limitation of the study was false elevation of ALT/AST during adult recruitment due to a technical error. In both study arms, one serious adverse event was reported, both considered unlikely related to the study drugs. Dizziness, nausea, headache, and diarrhea among adults, and headaches in children, were nonsignificantly more frequently observed in the BE-PEP group. In this study, we observed that safety of single-dose bedaquiline 800 mg in combination with rifampicin is comparable to rifampicin alone, although non-inferiority of QTc changes was demonstrated in children only after adjusting for the baseline QTc measurements. A Phase 3 cluster randomized efficacy trial is currently ongoing in the Comoros. ClinicalTrials.gov NCT05406479.

A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial

IntroductionRobotic-assisted complete mesorectal excision (RATME) is increasingly being used by colorectal surgeons. Most surgeons consider RATME a safe method, and believe it can facilitate total mesorectal excision (TME) in rectal cancer, and may potentially have advantages over intersphincteric resection (ISR) and anus preservation. Therefore, this trial was designed to investigate whether RATME has technical advantages and can increase the ISR rate compared with laparoscopic-assisted TME (LATME) in patients with middle and low rectal cancer.Methods and analysisThis is a multicenter, superiority, randomized controlled trial designed to compare RATME and LATME in middle and low rectal cancer. The primary endpoint is the ISR rate. The secondary endpoints are coloanal anastomosis (CAA) rate, conversion to open surgery, conversion to transanal TME (TaTME), abdominoperineal resection (APR) rate, postoperative morbidity and mortality within 30 days, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measurements will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.DiscussionThis trial will clarify if RATME improves ISR and promotes anus preservation in patients with mid- and low-rectal cancer. Furthermore, this trial will provide evidence on the optimal treatment strategies for RATME and LATME in patients with mid- and low-rectal cancer regarding improved operational safety.Trial registrationClinicalTrials.gov NCT06105203. Registered on October 27, 2023.

Nutritional guidance through digital media for glycemic control of women with gestational diabetes mellitus: a randomized clinical trial.

To compare the effectiveness of outpatient nutritional guidance supplemented by digital media with exclusively standard outpatient nutritional guidance in pregnant women with gestational diabetes mellitus (GDM). This was a randomized, patient-blinded clinical trial conducted at the Diabetes and Pregnancy outpatient clinic from February 2021 to January 2023. Pregnant women with GDM were randomly allocated into two groups: the control group received exclusively outpatient nutritional guidance, and the Intervention Group received outpatient nutritional guidance along with reminders via WhatsApp. Dietary intake (calories, carbohydrates, lipids, proteins, and fibers) was evaluated using 24 h dietary recalls. Glycemic control and the need for pharmacological treatment were also assessed. A total of 81 women were included, 34 allocated to the control group, and 47 to the intervention group. Patients were followed for a period of 4-8weeks. Significant differences were observed in some points of glycemic control between the two groups over the follow-up period. There were no statistical differences in pharmacological therapy (p=0.498); 188 24 h dietary recall were conducted inthe control group and 290 in the intervention group. Astatistically significant increase in lipid intake was observed in the intervention group over the follow-up period compared to the control group (p<0.001). No changes in calorie intake, other macronutrients, or fiber consumption were noted. Glycemic control was significantly improved with the addition of frequent text reminders about dietary choices, and a significant increase in lipid intake was seen in all women, more so in the reminder group.

Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial.

Transcranial direct current stimulation (tDCS) has been proposed as a new treatment in major depressive disorder (MDD). This is a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of 10-week home-based tDCS in MDD. Participants were 18 years or older, with MDD in current depressive episode of at least moderate severity as measured using the Hamilton Depression Rating Scale (mean = 19.07 ± 2.73). A total of 174 participants (120 women, 54 men) were randomized to active (n = 87, mean age = 37.09 ± 11.14 years) or sham (n = 87, mean age = 38.32 ± 10.92 years) treatment. tDCS consisted of five sessions per week for 3 weeks then three sessions per week for 7 weeks in a 10-week trial, followed by a 10-week open-label phase. Each session lasted 30 min; the anode was placed over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex (active tDCS 2 mA and sham tDCS 0 mA, with brief ramp up and down to mimic active stimulation). As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point improvement (10-week mean = 9.58 ± 6.02) and sham 7.14 ± 6.10 point improvement (10-week mean = 11.66 ± 5.96) (95% confidence interval = 0.51-4.01, P = 0.012). There were no differences in discontinuation rates. In summary, a 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety. ClinicalTrials.gov registration: NCT05202119.

Neutrophil activation markers can predict rheumatoid arthritis treatment response to the Janus Kinase 1/2 inhibitor baricitinib.

Neutrophils play an important role in regulating immune and inflammatory responses in rheumatoid arthritis (RA). We assessed whether baricitinib, a JAK1/JAK2 inhibitor, could reduce neutrophil activation, and whether a neutrophil activation score could predict treatment response. Markers of neutrophil activation, calprotectin, and neutrophil extracellular traps (NETs) were analyzed using ELISA in RA plasma (n=271) and healthy controls (n=39). For RA patients, neutrophil activation markers were measured at baseline, 12 weeks, and 24 weeks after treatment with placebo, 2 mg, and 4 mg baricitinib. Whole blood RNA analyses from multiple randomized baricitinib RA trials were performed to study neutrophil-related transcripts (n=1651). Baseline levels of plasma neutrophil markers were elevated in RA patients compared to healthy controls (p<0.001). Baricitinib reduced levels of soluble calprotectin at 12 and 24 weeks, especially in RA patients responding to treatment, as determined by ACR20. Whole blood RNA analysis revealed similar changes in the predominant neutrophil markers calprotectin and FcαRI upon treatment with baricitinib in three randomized clinical trials involving RA patients at various stages of disease modifying therapy. Clustering analysis of plasma activation markers showed elevated levels of calprotectin and NETs, e.g., a neutrophil activation score, at baseline, could predict treatment response to baricitinib. In contrast, CRP levels could not distinguish between responders and non-responders. Neutrophil activation markers may add clinical value in predicting treatment response to baricitinib and other drugs targeting RA. This study supports personalized medicine, in treating RA patients, not only based on symptoms, but also based on immunophenotyping.

Assessing the Impact of the Prostate Cancer Patient Empowerment Program (PC-PEP) on Relationship Satisfaction, Quality of Life, and Support Group Participation: A Randomized Clinical Trial.

Background/Objectives: The Prostate Cancer Patient Empowerment Program (PC-PEP) is a 6-month, home-based intervention aimed at enhancing mental health in men undergoing curative prostate cancer treatment. This exploratory secondary analysis evaluates PC-PEP's impact on relationship satisfaction, quality of life, and support group attendance among partnered participants. Methods: In a crossover randomized clinical trial ClinicalTrials.gov identifier: NCT03660085) of 128 men aged 50-82 scheduled for curative prostate cancer surgery or radiotherapy, 119 participants in relationships were included. Of these, 59 received the 6-month PC-PEP intervention, while 60 were randomized to a waitlist-control arm, receiving standard care for 6 months before starting PC-PEP. The intervention included daily emails with video instructions on mental and physical health, diet, social support, fitness, stress reduction, and intimacy. Outcomes were assessed using the Dyadic Adjustment Scale (DAS) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Results: While relationship satisfaction remained stable, a significant improvement in emotional well-being was observed at 12 months in participants undergoing radiation therapy (p = 0.045). The PC-PEP intervention also led to significantly higher support group attendance at both 6 months (p = 0.001) and 12 months (p = 0.003), emphasizing its role in fostering social support and community engagement. Conclusions: The PC-PEP program effectively maintains relationship satisfaction and enhances emotional well-being, particularly in patients with fewer physical side effects. Its design promotes comprehensive care by integrating physical, psychological, and social support, making it a valuable resource for improving the quality of life in prostate cancer patients and potentially applicable to other cancer types.

High-Risk Medications in Persons Living With Dementia

Individuals with Alzheimer disease (AD) and Alzheimer disease-related dementias (ADRD) may be at increased risk for adverse outcomes relating to inappropriate prescribing of certain high-risk medications, including antipsychotics, sedative-hypnotics, and strong anticholinergic agents. To evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD. This prospective, open-label, pragmatic randomized clinical trial, embedded in 2 large national health plans, was conducted from April 2022 to June 2023. The trial included patients with AD or ADRD and use of any of 3 drug classes targeted for deprescribing (antipsychotics, sedative-hypnotics, or strong anticholinergics). Patients were randomized to 1 of 3 arms: (1) a mailing of educational materials specific to the medication targeted for deprescribing to both the patient and their prescribing clinician; (2) a mailing to the prescribing clinician only; or (3) a usual care arm. Analysis was performed using a modified intention-to-treat approach. The primary study outcome was the dispensing of the medication targeted for deprescribing during a 6-month study observation period. Secondary outcomes included changes in medication-specific mean daily dose and health service utilization. Among 12 787 patients included in the modified intention-to-treat analysis, 8742 (68.4%) were female, and the mean (SD) age was 77.3 (9.4) years. The cumulative incidence of being dispensed a medication targeted for deprescribing was 76.7% (95% CI, 75.4-78.0) in the patient and prescriber mailing group, 77.9% (95% CI, 76.5-79.1) in the prescriber mailing only group, and 77.5% (95% CI, 76.2-78.8) in the usual care group. Hazard ratios were 0.99 (95% CI, 0.94-1.04) for the patient and prescriber group and 1.00 (95% CI, 0.96-1.06) for the prescriber only group compared with the usual care group. There were no differences between the groups for secondary outcomes. These findings suggest medication-specific educational mailings targeting patients with AD or ADRD and their clinicians are not effective in reducing the use of high-risk medications. ClinicalTrials.gov Identifier: NCT05147428.

Effect of kegel pelvic floor muscle exercise on improving urinary disorder in rectum cancer patients after rectal surgery: a randomized clinical trial.

Postoperative urinary dysfunction poses a significant challenge for rectal cancer patients. While pelvic floor muscle training (PFMT) has shown promise in other contexts, its efficacy following rectal cancer surgery remains uncertain. A clinical trial involving 79 rectal cancer patients found that initiating Kegel exercises post-surgery led to significant improvements in urinary symptoms compared to standard care. Adherence to exercises correlated with symptom reduction, with no reported adverse events. We have defined the main outcome of our study as the improvement in urinary function scores post-surgery. Effectiveness is considered as any statistically significant improvement in these scores. Early initiation of Kegel exercises shows promise in alleviating postoperative urinary dysfunction in rectal cancer patients. Further research is needed to optimize postoperative care protocols and enhance patient outcomes.

Meal replacements on obesity and leptin: a systematic review and meta-analysis.

The global prevalence of obesity and overweight is a significant concern in the field of public health. Numerous interventional studies have been conducted to assess the possible meal replacements (MRs) effect on anthropometric indicators and indices and laboratory test that reflect obesity. However, there are no comprehensive results in this field. The study aim was to understand the possible effects of MRs on body weight, body mass index (BMI), fat mass, waist circumferences (WC), and leptin levels. A systematic search was conducted in five electronic databases in order to find randomized clinical trials (RCTs) that examined the possible MRs effect on obesity. Analyses were performed in R software, version 4.2.1. The random-effects model analysis was used to provide pooled mean difference and 95% confidence intervals (95% CI). Seventy studies were included. Body weight (WMD: -3.35 kg, 95% CI: -4.28 to -2.42), BMI (WMD: -1.12 kg/m2, 95% CI: -1.51 to -0.72), fat mass (WMD: -2.77 kg, 95% CI: -3.59 to -1.6), WC (WMD: -2.82 cm, 95% CI: -3.51 to -2.12) were significantly reduced after MRs compared to control. No significant effect was observed on leptin (WMD: -3.37 ng/ml, 95% CI: -8.23 to 1.49). Subgroup analyses indicated that impact of total MRs on anthropometric factors was greater in comparison to partial MRs. Considering other lifestyle factors, MRs can lead to anthropometric indicators and indices reduction.

Community Health Workers Linking Clinics and Schools and Asthma Control

Childhood asthma is characterized by pervasive disparities, including 3-fold higher hospitalization rates and 7-fold higher death rates for Black children compared with White children. To address asthma disparities, one must intervene in all lived environments. To determine if a community health worker (CHW) intervention to connect the primary care, home, and school for low-income minoritized school-aged children with asthma and their caregivers improves asthma control. This study was a hybrid effectiveness/implementation trial using a 2 × 2 factorial, cluster randomized clinical trial design of 36 schools crossed with participant-level randomization into a clinic-based CHW intervention. The study was conducted from May 2018 to June 2022. The intervention took place in primary care offices, homes, and 36 West Philadelphia, Pennsylvania, public and charter schools. Children aged 5 to 13 years with uncontrolled asthma were recruited from local primary care practices. Asthma management, trigger remediation, and care coordination occurred in school, home, and primary care settings. Children were followed up for 12 months. The Yes We Can Children's Asthma Program, Open Airways For Schools Plus, and school-based asthma therapy were implemented. Improvement in asthma control, as measured by the Asthma Control Questionnaire, comparing the mean difference between groups 1 year after randomization with their baseline (difference in differences). Both primary care and school interventions were dramatically disrupted by the COVID-19 pandemic; therefore, stratified analyses were performed to assess per-protocol intervention efficacy before the pandemic disruptions. A total of 1875 participants were approached, 1248 were excluded, and 1 was withdrawn. The 626 analyzed study participants (mean [SD] age, 8.7 [2.4] years; 363 male [58%]) self-identified as Black race (96%) and non-Hispanic ethnicity (98%). Although all groups had statistically significant improvements in asthma control from baseline to 12 months (P- group: -0.46; 95% CI, -0.58 to -0.33; P+ group: -0.57; 95% CI, -0.74 to -0.44; S- group: -0.47; 95% CI, -0.58 to -0.35; S+ group: -0.59; 95% CI, -0.74 to -0.44), none of the difference-in-differences estimates from the primary prespecified models showed a clinically meaningful improvement in asthma control. Analysis from the prepandemic interval, however, demonstrated that children in the combined clinic-school intervention had a statistically significant improvement in asthma control scores compared with control (-0.79; 95% CI, -1.40 to -0.18). This randomized clinical trial provides preliminary evidence that connecting all lived environments for care of children can be accomplished through linkages with CHWs.

Protocol for a prospective randomized trial of surgical versus conservative management for unstable fractures of the distal radius in patients aged 65 years and older.

The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups. A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178). The results of this study will help guide treatment of dorsally displaced distal radial fractures in the elderly and assess whether surgery offers functional benefit to patients. This is an important finding, as the number of elderly distal radial fractures is estimated to increase in the future due to the ageing population. Evidence-based management strategies are therefore required to ensure the best outcome for the patient and to optimize the use of increasingly scarce healthcare resources.