Eligible Participants Research Articles

Use of opioids and opioid alternatives during general anesthesia: a pan-Canadian survey among anesthesiologists.

While there is limited patient-centred evidence (i.e., evidence that is important for patients and end-users) to inform the use of pharmacologic opioid minimization strategies (i.e., the use of opioid alternatives) for adult surgical patients requiring general anesthesia, such strategies are increasingly being adopted into practice. Our objectives were to describe anesthesiologists' beliefs regarding intraoperative opioid minimizing strategies use and utility, and to explore important clinical decision-making factors. We conducted a pan-Canadian web-based survey of anesthesiologists that was distributed using a modified Dillman technique. Our multidisciplinary team, including a patientpartners panel, participated in the process of domains and items generation, items reduction, formatting, and composition. Our sampling frames were members of the Canadian Anesthesiologists' Society and members of the Association des Anesthésiologistes du Québec. We used the newsletters of each organization to distribute our survey, which was available in English and French and housed on the LimeSurvey (LimeSurvey GmbH, Hamburg, Germany) platform. From our eligible sampling frame, 18% completed the survey (356 respondents out of 2,008 eligible participants). Most of the respondents believed that using opioid minimization strategies during general anesthesia could improve postoperative clinical outcomes, including pain control (84% agree or strongly agree, n = 344/409). Reported use of pharmacologic opioid minimization strategies was variable; however, most respondents believed that nonsteroidal anti-inflammatory drugs, acetaminophen, N-methyl-D-aspartate receptor antagonists (ketamine), α2-adrenoceptor agonists (dexmedetomidine), corticosteroids, and intravenous lidocaine improve prostoperative clinical outcomes. The primary factors guiding decision-making regarding the use of opioid minimization strategies were postoperative acute pain intensity, the impact of acute pain on functioning, patient well-being (i.e., quality of recovery) and patient satisfaction with care. A lack of evidence was the most important barrier limiting the use of opioid minimization strategies. In our survey of Canadian anesthesiologists, several opioid minimization strategies were believed to be effective complements to general anesthesia, although there was substantial variation in their reported use. Future randomized controlled trials and systematic reviews evaluating the effectiveness of opioid minimization strategies should prioritize patient-centred outcome measures assessment such as the quality of recovery or the impact ofacute pain on functioning.

Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016–01)

BackgroundGranulosa cell ovarian tumors (GCT) are orphan disease with limited treatments. Hormone therapy is a potential treatment, due to the overexpression of hormone receptors in most tumors. This study explores the activity of the antiandrogen, enzalutamide, in metastatic cases. MethodsWe designed a phase II clinical trial under the Spanish Collaborative Group for Transversal Oncology and Rare and Orphan Tumors (GETTHI). Eligible participants were adult women with advanced GCT. Primary endpoint was objective response rate. Secondary endpoints included clinical benefit rate, progression-free survival, overall survival, and safety profile. Patients received enzalutamide 160 mg once daily. ResultsFrom April 2018 to March 2020, eighteen patients were screened, and sixteen were included across nine institutions. Median age was 56.4 years (range 45–71), and most were Caucasian (14 cases), one Arabian and one Latin. ECOG performance status was zero in 13 cases (81 %) and one in three (19 %). Six patients (38 %) had previously received hormone therapy as adjuvant treatment or for advanced disease, and 15 (94 %) chemotherapy. Median time from metastasis to study entry was 96 months (range 4.5–198).No objective response was observed, but the clinical benefit rate reached 68.8 % (95 % CI [46 %–91.5 %]). Median progression-free survival was 3.8 months (95 % CI [1.36–6.14]). Median overall survival was not reached, with a median follow-up of 6 months (range 2.2–19).At the time of database closure, 14 patients had discontinued treatment, 13 due to disease progression and one by personal choice. Two deaths attributed to disease progression were recorded.Five grade 3 adverse events were reported, with only one (asthenia) deemed related to the therapy. ConclusionsAlthough enzalutamide demonstrated modest activity in GCT, durable stabilization was observed in some cases.Trial Registration:ClinicalTrials.gov Identifier: NCT03464201

Racial and ethnic and sex differences in at-home estimates of sleep-disordered breathing parameters among Mexican American, Black, and Non-Hispanic White adults.

Background Racial and ethnic and sex differences in sleep may exist, but there are limited data directly comparing objective estimates of sleep-disordered breathing (SDB), particularly in rapid eye movement (REM) versus non-rapid eye movement (NREM) sleep, among Black, Mexican American (MA) and non-Hispanic White (NHW) men and women. Our goal is to investigate health disparities in SDB in a new, diverse cohort of older adults. Research Question Do SDB parameters during REM and NREM sleep differ by race and ethnicity or sex in community-dwelling older adults?. Methods The Dormir Study conducted a comprehensive sleep examination among eligible participants enrolled in the ongoing community-based Health and Aging Brain Study-Health Disparities (HABS-HD) cohort (2020-4), among Black, MA, and NHW adults aged 50 years and older. Here we characterize racial and ethnic and sex differences in SDB indices assessed by an FDA-approved Peripheral Arterial Tonometry (PAT)-based home sleep testing system. Results We examined 821 participants, including 543 (66.1%) women, and 284 (34.6%) MA and 174 (21.2%) Black individuals, with a mean age of 66.6±8.5 years. Around half (50.5%) of the participants had moderate to severe SDB as defined by the respiratory event index (REI based on 3% desaturations) of ≥15/ hour, 72.7% with moderate to severe REM SDB (REM-REI ≥ 15/hour) and 39.5% with moderate to severe NREM SDB (NREM-REI ≥15/hour). The prevalence of SDB did not differ by race or sex. However, significant racial and ethnic and sex differences were observed for REM-specific SDB metrics. Overall, Black women had the highest REM REI, and NHW men had the lowest REM REI and REM ODI. After controlling for age, sex, education, income, employment status, cognitive status, BMI, history of hypertension, diabetes, stroke, and coronary heart disease, and sleep medication use, Black participants had a REM-REI that was 3 events per hour higher than that of NHW adults, while NREM-REI were similar. MA individuals had similar REM or NREM SDB parameters compared to NHW adults but exhibited higher average blood oxygen levels. Conclusions In this community-based cohort of middle- to older-aged NHW, MA, and Black adults, PAT-based measures of in-home sleep indicate a higher prevalence of REM SDB in Black adults, particularly Black women, compared to their NHW counterparts; this contrasts with the similar NREM parameters observed across racial and ethnic groups. Given the close link between REM SDB and adverse health outcomes, clinicians should pay more attention to this sleep apnea phenotype, especially in minoritized populations.

Sex differences in LDL-C reduction response to evolocumab: A propensity score matching analysis.

Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have been shown to improve cardiovascular outcomes by reducing low-density lipoprotein cholesterol (LDL-C). However, sex differences in the efficacy of evolocumab remain unclear. This study aimed to investigate sex differences in the efficacy of evolocumab using real-world data. Data were collected from the First Affiliated Hospital of Guangxi Medical University. A total of 416 eligible patients were selected from 1463 patients treated with evolocumab for secondary prevention. Clinical data, including individual characteristics and lipids profiles, were recorded. Propensity score matching (PSM) was used to control for potential confounders, with covariates including age, body mass index, smoking status, and diabetes. All eligible participants were propensity-matched 1:1 for female versus male with a match tolerance of 0.02. The efficacy of evolocumab in females and males was compared by PSM-adjusted analysis. In the PSM analysis, a significant difference was found in the relative percentage reduction of LDL-C between females and males (-42.7% vs. -54.4%, p < 0.001). In addition, the absolute LDL-C reduction was lower in females compared to males (interquartile range: -1.5 [-2.2, -0.8] mmol/L vs. -1.9 [-2.5, -1.0] mmol/L, p = 0.018). The rate of target LDL-C attainment was lower in females than in males after treatment with evolocumab (21.6% vs. 39.8%, p = 0.009). These results suggest that males have a better response to evolocumab in term of LDL-C reduction compared to females.

Oral health-related beliefs among a sample of pregnant women in Southwestern Ontario: a descriptive study

IntroductionUnfavorable beliefs about oral health and dental treatment during pregnancy can lead to the avoidance of dental care and the underutilization of dental services, adversely affecting adherence to good oral hygiene practices and, consequently, the health of the fetus. This study investigated the commonly held oral health beliefs among pregnant women in Southwestern Ontario, Canada.MethodsParticipants were recruited from the Family Medicine Obstetrics Clinic in London, Ontario, Canada. Eligible participants were pregnant women aged 18 or older, excluding those unwilling to participate. Participants completed a 33-item self-administered questionnaire, including three open-ended questions about oral health beliefs and their impacts on pregnancy, which were analyzed for this study. Thematic analysis in NVivo identified key patterns, while analysis determined the most common beliefs and the degree of diversity in responses. Responses were categorized into sub-themes, and the frequency and percentage of each category were calculated.ResultsA total of 130 participants met the inclusion criteria. Among them, 40.7% (n = 46) believed that oral health impacts their child's health, 48.2% (n = 53) believed that dental treatment affects fetal health, and 64.4% (n = 76) believed that pregnancy influences their oral health. Many beliefs regarding oral health during pregnancy regarded infection risks. Participants held negative beliefs about the effects of antibiotics, analgesics, and dental x-rays during pregnancy. Common beliefs about the impacts of pregnancy on oral health included developing conditions, such as tooth sensitivity, caries, and gingivitis, as well as a loss of minerals to the fetus.ConclusionThis study revealed important misconceptions and concerns about oral health and dental treatment among pregnant women in Southwestern Ontario. The findings highlighted the need for enhanced oral health education for pregnant women to address these misconceptions and promote proper care during pregnancy. Healthcare providers are encouraged to focus on dispelling myths, emphasizing the safety of necessary dental treatments, and reinforcing the significance of maintaining good oral health for maternal and fetal well-being.

Addressing Inpatient Hyponatremia Through Targeted Automatic E-consults: A Pilot Randomized Trial.

Hyponatremia is the most common electrolyte abnormality in hospitalized patients. Treatment of hyponatremia is associated with improved outcomes, but more than one in three cases of new onset hyponatremia is not corrected by the time of hospital discharge. Nephrologist input may improve the diagnosis and treatment of hyponatremia, but specialist resources are limited. Targeted automatic electronic consultations (TACos) may be one approach to provide expert nephrologist guidance to the workup and management of hyponatremia using a scalable model. Evaluate the feasibility and acceptability of a TACo intervention for hospitalized patients with hyponatremia. Single-site, parallel-group cluster randomized trial. Adult inpatients with hyponatremia on the hospital medicine service. A nephrologist conducted TACos on intervention patients, making diagnostic and therapeutic recommendations daily (if warranted) until discharge or resolution of hyponatremia. Measures of feasibility included the number of eligible participants, percentage receiving TACos, number of TACos per participant, and percentage of formal nephrology consults. Acceptability was assessed by a post-intervention survey. Clinical outcomes, including the percentage of hyponatremia cases that resolved by discharge, were also assessed. We identified 62 patients who met inclusion criteria: 38 in the intervention group and 24 in the control group. A nephrologist determined that 26 of 38 intervention patients (68%) would likely benefit from diagnostic and management recommendations; 67 TACos were performed (mean 2.6 per patient). Fourteen of 18 primary team physicians (78%) reported that the e-consults changed their management, and 15 of 18 (83%) wanted TACOs to continue. Resolution of hyponatremia, length of stay, 30-day readmissions, and costs were similar in the intervention and control groups. Inpatient TACos for hyponatremia were feasible and acceptable to primary teams, and frequently led to changes in diagnosis and management. Further studies are needed to determine the impact of the TACo model on clinical outcomes and cost-effectiveness.

Self-Monitoring With Coping Skills and Lifestyle Education for Hypertension Control in Primary Care.

Self-monitoring with support, lifestyle modifications, and emotion management improves blood pressure (BP). Patients with hypertension need continual support to modify behaviors, but time pressures limit lifestyle education in primary care settings. Using mixed methods, we aimed to study the feasibility and acceptability of an innovative 6-week program that combined self-monitoring with coping skills and lifestyle education for patients with uncontrolled hypertension. Patients with uncontrolled hypertension interested in lifestyle modifications before intensifying medications were enrolled from primary care clinics. Patients self-monitored emotions, behaviors, and BPs and received education from medical providers and mind-body therapists through shared medical appointments (SMAs) with an option of weekly printed materials. Over 6 months, 31 eligible participants completed the program with higher uptake (21/41) from physician referrals (74.2% women, 41.9% Black, median household income $100 000). Fourteen participants opted for weekly educational materials due to upcoming SMA sessions being fully booked or personal schedules. Pre- to post-intervention paired t-test showed improvement in systolic BP of 11.6mmHg (95% CI, 6.6-16.6, p < 0.0001), and hypertension control rate improved by 36% (11/31) post-intervention. Higher baseline systolic BP was associated with higher BP reduction (p < 0.001). Thematic analysis showed the perceived benefit of self-awareness, education, and peer support, whereas time constraints were perceived as challenges. Self-monitoring with education on coping skills and lifestyle modification is feasible and improved BP and hypertension control across diverse primary care patients interested in lifestyle modifications; however, few low-income patients enrolled. Less burdensome and community-based interventions may improve participation in low-income patients.

Psilocybin-assisted neurofeedback for the improvement of executive functions: a randomized semi-naturalistic-lab feasibility study.

Executive function deficits, common in psychiatric disorders, hinder daily activities and may be linked to diminished neural plasticity, affecting treatment and training responsiveness. In this pioneering study, we evaluated the feasibility and preliminary efficacy of psilocybin-assisted frontal-midline theta neurofeedback (NF), a neuromodulation technique leveraging neuroplasticity, to improve executive functions (EFs). Thirty-seven eligible participants were randomized into an experimental group (n = 18) and a passive control group (n = 19). The experimental group underwent three microdose sessions and then three psilocybin-assisted NF sessions, without requiring psychological support, demonstrating the approach's feasibility. NF learning showed a statistical trend for increases in frontal-midline theta from session to session with a large effect size and non-significant but medium effect size dynamical changes within sessions. Placebo effects were consistent across groups, with no tasks-based EF improvements, but significant self-reported gains in daily EFs-working memory, shifting, monitoring and inhibition-showing medium and high effect sizes. The experimental group's significant gains in their key training goals underscored the approach's external relevance. A thorough study with regular sessions and an active control group is crucial to evaluate EFs improvement and their specificity in future. Psilocybin-enhanced NF could offer significant, lasting benefits across diagnoses, improving daily functioning. This article is part of the theme issue 'Neurofeedback: new territories and neurocognitive mechanisms of endogenous neuromodulation'.

Truth is relative; Client report versus provider report, a post-modern analysis of data from a trial in the private retail medicine sector.

In malaria-endemic countries, private retail outlets are a major source of antimalarials for individuals experiencing an acute febrile illness. However, there remains a challenge in how the decision to dispense the drugs is made. The lack of malaria diagnostic tools in the retail sector leads to a presumptive approach to diagnosis and overuse of ACTs. The TESTsmART study trained retail outlet attendants to perform malaria rapid diagnostic tests (mRDTs) in conjunction with a mobile application to capture testing and drug dispensing data. Concurrently, febrile clients were randomly selected for exit interviews outside the outlet, and analogous information about testing and drug purchasing was recorded based on self-report. A small subset of clients enrolled in exit interviews were also asked to participate in exit Plasmodium falciparum mRDT testing to confirm the accuracy of mRDTs in the outlet and to estimate malaria positivity amongst untested clients. In this sub-study, comparison of these two concurrent data sources showed the testing rate for eligible participants was slightly lower in the exit interview (42.8%, 2436/5695) than in the app (51.1%, 24,446/49,804). We noted important differences in the experiences of testing and adherence reported by outlets compared to clients; 11.0% of clients had positive mRDT reported in the app (and validated by photo review) compared to 35.3% from exit interviews. Outlets reported that 97% of test-positive clients received a first-line Artemether Combination Therapy (ACT), but only 77% of clients who reported a positive test also reported receiving the first-line ACT in the exit interview. For test-negative clients, 35% received an ACT based on outlet reports compared to 25% by exit interviews. Among 109 clients randomly selected for re-test at exit interview, nearly two-thirds of those who reported a positive test from the outlet had a negative mRDT (64.3%, 9/14) when retested. Contrasting outcomes reported by the provider and the client highlight barriers to improving testing and adherence for malaria as well as challenges for monitoring case management in the retail sector. These include accurate communication of results to the client, poor confidence in a negative result, and reluctance to withhold antimalarials from test-negative clients.

Design and Baseline Characteristics of the STRIDE Trial: evaluating Semaglutide in People with Symptomatic Peripheral Artery Disease and Type 2 Diabetes.

People with lower extremity peripheral artery disease (PAD) suffer from a high burden of symptoms and significant functional impairment. There are few therapies that improve function and reduce symptoms in this population. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been shown to improve glycemic control, reduce body weight and reduce the risk of major adverse cardiovascular events, in people with atherosclerotic cardiovascular disease and type 2 diabetes (T2D). STRIDE (NCT04560998) is a randomized, placebo-controlled, double-blind phase 3b trial evaluating 1mg once-weekly subcutaneous semaglutide (GLP-1 RA) vs. placebo, in people with symptomatic PAD (Fontaine IIa claudication) and T2D. Eligible participants were≥18 years, had hemodynamically stable PAD, had no planned intervention, and were not receiving a GLP-1 RA. The primary endpoint is change in maximum walking distance on a constant-load treadmill (CLT). Secondary endpoints include quality of life and cardiometabolic assessments. A total of 792 participants were randomized in 20 countries. Participants' median age was 68 and they had T2D for a median of 12 years. Risk factors included 25.6% current smokers, 87.9% with hypertension, and 42.7% with coronary heart disease. The mean BMI was 29.6kg/m2 and mean HbA1C was 7.3%. Participants exhibited baseline functional impairment with a median maximum walking distance of 186 meters on a CLT. STRIDE has enrolled participants with symptomatic PAD and T2D, frequent risk factors and comorbidities, and functional impairment. The trial will provide evidence for the functional outcomes with semaglutide in people with PAD and T2D.

Efficacy of ursodeoxycholic acid for bile reflux after distal gastrectomy in patients with gastric cancer: A secondary analysis of the PEGASUS-D randomized clinical trial.

Few studies have been conducted on the prevention of bile reflux in gastric cancer patients who have undergone gastrectomy. The aim of this study was to evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) in preventing bile reflux after gastrectomy in patients with gastric cancer. This study was a secondary analysis of the PEGASUS-D trial, a randomized, double-blind, placebo-controlled clinical trial. Adults with a diagnosis of gastric cancer who underwent gastrectomy were enrolled. Eligible participants were randomly assigned to receive 300mg of UDCA, 600mg of UDCA, or placebo at a ratio of 1:1:1. UDCA and placebo were administered daily for 52 weeks. The primary outcomes included bile reflux symptoms at each time point, percentage of participants with bile reflux, and the grade of gastritis. Among 521 participants who underwent randomization, 151, 164, and 150 participants were analyzed from the 300 mg UDCA, 600mg UDCA, and placebo groups, respectively. The difference in symptoms between the three groups was not significant. Bile reflux was less evident in the UDCA group than in the placebo group; however, this difference was significant only in the 300-mg group at 12 months post-operation (odds ratio, 0.44; P = 0.0076). A significant reduction in gastritis was also observed in the 300-mg group at 12 months post-operation (odds ratio, 0.50; P = 0.0368) compared to the placebo group. This study showed that UDCA administration significantly reduced bile reflux and gastritis by approximately 50% at the 12 months-postoperative follow-up in patients who underwent gastrectomy for gastric cancer.

Are toddlers with neurosensory impairment more difficult to follow up? A secondary analysis of the hPOD follow-up study

ObjectiveTo describe strategies used to maximise follow-up after a neonatal randomised trial, how these differed for families of different ethnicity, socioeconomic status and urban versus rural residence and investigate relationships...

Metabolic Dysfunction-Associated Steatotic Liver Disease Increases the Risk of Severe Infection: A Population-Based Cohort Study.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is linked to various intrahepatic and extrahepatic diseases, but its association with severe infectious disease remains to be investigated. We analysed data from the Shanghai Suburban Adult Cohort and Biobank, encompassing participants enrolled in 2016 and 2017 with available abdominal ultrasonography data, and followed them up until December 2022 (median follow-up = 5.71 years). We categorised the participants into the MASLD group and those without steatotic liver disease (non-SLD). Multivariable-adjusted Cox regression was used to estimate hazard ratios (HR) for severe infections in patients with MASLD compared to the non-SLD group. Cumulative incidences were calculated while accounting for competing risks (non-infection-related deaths). Mediation analyses were performed to explore the roles of cardiometabolic risk factors in the association between MASLD and severe infections. Among the 33 072 eligible participants (mean age 56.37 years; 38.20% male), 11 908 (36.01%) were diagnosed with MASLD at baseline. Severe infections occurred in 912 (7.66%) MASLD patients and 1258 (5.94%) non-SLD. The rate of severe infections per 1000 person-years was higher in MASLD patients (13.58) than in comparators (10.48) (fully adjusted HR 1.18, 95% CI 1.07-1.30). The most frequent infections in MASLD were respiratory (7.25/1000 person-years) and urinary tract infections (2.61/1000 person-years). The 5-year cumulative incidence of severe infections was 6.79% (95% CI 6.36-7.26) in MASLD and 5.08% (95% CI 4.79-5.38) in comparators. Cardiometabolic risk factors, including waist circumference, triglycerides and HbA1C, partially mediate the association between MASLD and severe infections. Patients with MASLD were at significantly higher risk of incident severe infections compared to the non-SLD group. Future studies are needed to elucidate the mechanisms linking MASLD to severe infections.

Determinants of preterm delivery among mothers who gave birth in hospitals of Wolaita zone, southern Ethiopia, 2023: unmatched case-control study

BackgroundPreterm delivery refers to childbirth that occurs before 37 full weeks’ gestation. Globally, around 13.4 million babies are born preterm annually, a million died due to its complications. Identifying its determinants is mandatory to decrease preterm birth and thereby neonatal deaths. Therefore, this study aimed to identify the determinants of preterm delivery among mothers who gave birth in hospitals in the Wolaita zone, southern Ethiopia.MethodsA hospital-based unmatched case-control study design was conducted from March 29 to May 20, 2023, in the Wolaita zone, southern Ethiopia. Cases were women who gave birth after 28 weeks and before 37 completed weeks, and controls were women who gave birth at and after 37 and before 42 weeks of gestation from the first day of the last normal menstrual period. A consecutive sampling method was used. Data were collected by a structured interviewer-administered questionnaire. Data were coded and entered into Epi data 3.1 and analyzed by using SPSS version 25. Variables that had a P-value < 0.25 in the bivariate logistic regression analysis were entered into a multivariable logistic regression model. Finally, p-value < 0.05 was used to claim statistical significance.ResultFrom a total of 405 eligible participants, 399 respondents (133 cases and 266 controls) participated in this study with a response rate of 98.52%. The result of the multivariable analysis shows that mothers who resided in rural areas [AOR = 2.78:95% CI (1.51–5.12)], not receiving support from their partner [AOR = 2.37:95% CI (1.24–4.51)], less than four antenatal care visits [AOR = 4.52:95%CI (2.38–8.57)], developed pregnancy-induced hypertension [AOR = 5.25:95%CI (2.27–12.14)] and exposed for intimate partner violence [AOR = 2.95:95%CI (1.105–7.85)], had statistically significant association with experiencing preterm delivery.Conclusion and recommendationMost of the determinants for preterm delivery have been proven modifiable. Thus, designing new strategies, providing comprehensive mobile clinic services to address hard-to-reach areas and Health care providers should give due attention to mothers with pregnancy-induced hypertension and exposure to intimate partner violence and increase the awareness of antenatal care follow-up and benefit of support during pregnancy to reduce preterm delivery.

Effects of Virtual Reality Therapy for Patients With Breast Cancer During Chemotherapy: Randomized Controlled Trial.

Patients with breast cancer endure high levels of psychological and physical pain. Virtual reality (VR) may be an acceptable, safe intervention to alleviate the negative emotions and pain of patients with cancer. We aimed to test the long-term effects of VR on psychological distress and quality of life (QOL) with traditional care in Chinese patients with breast cancer. We also explored the intervention mechanism and the acceptability of VR. A total of 327 eligible participants were randomly assigned to a VR intervention group or a control group. The Distress Thermometer, QLQ-C30 (Quality of Life Questionnaire version 3.0), and Virtual Reality Symptom Questionnaire were assessed at baseline, postintervention (3 mo), and follow-up (6 mo). Analysis followed the intention-to-treat (ITT) principle. The generalized estimating equations model was used to analyze the longitudinal data, and the PROCESS macro was used to analyze the mediating effect. Compared with the control group, patients with breast cancer in the VR group had lower distress scores (P=.007), and higher health-related QOL scores (physical, role, emotional, cognitive, and social functioning) after 6 months (P<.05). Psychological distress had mediating effects on the longitudinal association between VR and the health-related QOL (indirect effect=4.572-6.672, all P<.05). VR intervention technology may help reduce distress and improve QOL for patients with breast cancer over time. By incorporating a mediating analysis, we showed that the QOL benefits of VR intervention was manifested through positive effects on psychological distress risk factors.

The efficacy of wrapping with polyglycolic acid mesh and fibrin glue in preventing clinically relevant pancreatic fistula after minimally invasive distal pancreatectomy (WRAP Study): study protocol for a multicenter randomized controlled trial in Japan

BackgroundPostoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP.MethodsThis multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C).DiscussionThe WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety.Trial registrationThis trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120).

Association between serum IgM and all-cause mortality risk in Chinese centenarians: a prospective cohort study

BackgroundWe investigated the associations between IgM, IgG, IgA, and IgE levels and all-cause mortality risk in Chinese centenarians.MethodsAll participants were from the China Hainan Centenarian Cohort Study. Eligible participants were divided into quartiles based on their IgM, IgG, IgA, and IgE levels. We used restricted cubic spline analyses, Cox regression analyses, and Kaplan–Meier survival curves to analyze associations between IgM, IgG, IgA, and IgE and all-cause mortality risk.ResultsA total of 906 centenarian participants were included in this study (81.2% female; median age, 102 years). During a median follow-up of 30.1 months, 838 (92.5%) participants died. Restricted cubic spline analysis revealed a nonlinear relationship (“L” type) between serum IgM level and all-cause mortality. Compared with the higher three quartiles of serum IgM level, the lowest quartile was associated with a higher risk of death (Q1 versus Q2-Q4: HR, 1.365; 95% CI, 1.166–1.598; P < 0.001). Among individuals for whom IgM < 0.708 g/L (Q1), the risk of all-cause mortality was 36.5% higher. Kaplan–Meier analyses showed that centenarians with lower serum IgM levels had significantly shorter median survival time (Q1 versus Q2-Q4: 26 months versus 32 months, log-rank P = 0.001).ConclusionSerum IgM levels in centenarians significantly correlated with the risk of death, suggesting that they are suitable for predicting the overall risk of death in centenarians and can be used as an independent predictor of death.

Virtual reality for the management of pain and anxiety during outpatient manual vacuum aspiration for miscarriage or incomplete abortion: a mixed methods trial.

To evaluate the efficacy and acceptability of virtual reality (VR) as a distraction technique in the management of acute pain and anxiety during outpatient uterine aspiration using a manual vacuum aspirator (MVA). This mixed methods study included a prospective multi-centre randomised controlled trial and structured individual interviews. Of the 72 patients approached, 50 consenting, eligible participants were randomised to VR intervention (immersive video content 'The Forest of Serenity') or standard care during MVA for the management of miscarriage or incomplete abortion from July 2021-July 2022 across two university hospitals in London, UK. Expected and actual pain scores, and anxiety before and after the procedure were measured as numeric rating scores (0-10). Structured interviews were undertaken after the procedure in women randomised to VR. Statistical analysis of pain and anxiety scores were by intention-to-treat including all randomised participants, using Stata-12 software. Qualitative analysis was achieved by thematic analysis of transcribed interviews. There was no significant difference in pain or anxiety scores reported by participants randomised to VR compared with standard care. Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively (p-value 0.13), with corresponding anxiety scores at the end of the procedure 3.94 and 3.3 (p-value 0.57). Qualitative analysis from interviews was highly favourable from women randomised to VR with all participants reporting a positive experience. 90% (18/20) of participants reported that VR reduced their anxiety and 71% (15/21) stated that it helped to reduce or distract from their pain. While virtual reality did not decrease pain or anxiety scores during MVA, it is a feasible and acceptable option that may improve patient experience. Randomisation to VR during MVA did not reduce pain or anxiety scores. However, at structured interview most participants reported that VR reduced their anxiety and reduced or distracted them from their pain. VR is a feasible and acceptable option that may improve patient experience during MVA.

Dosimetry model for photobiomodulation based on anthropometric and hemodynamic variables in patients with orofacial pain post-Covid-19: Study protocol for randomized clinical trial.

Orofacial pain and tension headache are symptoms that affect a large portion of the population, compromising productivity, social ability, and functional development. The treatment for reducing painful sensation should be chosen carefully, as pharmacological treatment may bring side effects and overload the organism of patients in pain. Low-level laser therapy has been used with local and systemic [vascular] applications for pain control. However, there is still uncertainty in the literature about the ideal dosimetric parameters for photobiomodulation treatment according to patient characteristics. The objective of this project is to validate a dosimetry model based on the relationship between the effects of photobiomodulation with anthropometric and hemodynamic variables, both in local application and systemic application in patients with symptoms of orofacial pain and tension headache. For this purpose, 180 participants with orofacial pain post-covid eligible participants will be randomly assigned to Group 1-Local Photobiomodulation, Group 2-Vascular Photobiomodulation, Group 3-Placebo Local Photobiomodulation, or Group 4-Placebo Vascular Photobiomodulation [Therapy EC-DMC device, São Carlos, Brazil,- 660 nm, 100mW] using stratified block randomization. Before the application, sociodemographic information such as age, skin phototype [classified by the Fitzpatrick scale], weight, height, body mass index [BMI], oxygen saturation [SaO2], blood pressure [BP], heart rate [HR], and thickness of skin, fat, and facial muscles will be collected. During the application, we will collect local temperature, SaO2, BP, and HR. Before and after laser application, blood levels of lactate and hemoglobin, BP, and HR will be measured in the first and last session. In addition to demographic, anthropometric, and hemodynamic variables, the penetrated energy will be quantified using a power meter, and information from orofacial pain and headache symptom questionnaires will be analyzed. The Monte Carlo simulation technique will be used to systematically study the relationship between the light penetration profile into the target tissues and the most relevant variables, namely BMI, tissue layer thicknesses, and skin phototype. Light transmittance, measured in vivo and simulated, will be compared to validate a personalized dosimetry model. The results of this study contribute to validating a Monte Carlo Simulation model to calculate the appropriate dosimetry for photobiomodulation therapies in the control of patients with Post-Covid-19 orofacial pain. Trial registration number: NCT06065969.

Assessing Anxiety and Satisfaction Levels among Dental Students during Online Learning amid the COVID-19 Pandemic: A Cross-Sectional Study

Introduction: The COVID-19 pandemic led to widespread adoption of online learning. In April 2020, the Higher Education Commission (HEC) of Pakistan released policy guidance on online readiness with three levels: basic, effective, and exemplary. However, concerns about the quality and readiness for online curriculum delivery in Pakistan persisted. This study assesses the anxiety and satisfaction levels of undergraduate dental students with online classes during the pandemic. Methods: An analytical cross-sectional study was conducted between June and July 2020. Data were collected via email from undergraduate dental students of a private dental college using convenience sampling, after three months of online teaching. Two tools were used: a student satisfaction questionnaire adapted from Bolliger and Halupa’s study, and a student anxiety questionnaire. Frequencies, percentages, means, and standard deviations were calculated for satisfaction and anxiety scores. Univariate and multiple linear regression analyses were performed to assess factors associated with student satisfaction. Results: Out of 300 eligible participants, 237 responded (79% response rate). Most participants (53.16% female, 59.07% hostellers) had no prior experience with online learning (85.65%). The mean anxiety score was 54.87 (SD=9.6), and the mean satisfaction score was 58.63 (SD=16.66). Male students showed less satisfaction than females, though not statistically significant. Second-year students had significantly higher satisfaction scores than third- and fourth-year students. Conclusion: Most students had no prior experience with online learning, resulting in increased anxiety and poor satisfaction with the modality during the COVID-19 pandemic.