Epidemiological Study in Antiviral Innate Immunity.

This chapter summarizes the epidemiological study design of natural immune epidemiology studies based on recent COVID-19-related research. The epidemiological studies on antiviral innate immunity have mainly included randomized controlled trials (RCTs) and observational studies. Importantly, this chapter will discuss how to use these methodologies to answer an epidemiological question of natural immunity in the viral infection process based on previous studies. An observational case- or cohort-based study of antiviral innate immunity may support this theoretical hypothesis but is not appropriate for clinical practice or treatment. RCTs are the gold standard for epidemiological studies and occupy a greater role in the hierarchy of evidence.

Comparison of Intravenous Dexmedetomidine Versus Dexmedetomidine-Dexamethasone Combination for Preventing Postoperative Nausea and Vomiting in Adult Patients After Abdominal Surgeries.

INTRODUCTION:  Postoperative nausea and vomiting (PONV) is a common problem following general anesthesia and is one of the most unpleasant side effects that affects the patient after surgery and is the worst memory of the hospital stay. The present prospective randomized comparative study was designed to compare the effect of intravenous dexmedetomidine with dexmedetomidine-dexamethasone combination for preventing PONV following abdominal surgeries in adult patients and evaluating their sedative and analgesic effects. METHODOLOGY: A total of 75 patients (aged 18-65 years) were assigned to undergo this comparative study via block randomization using a sealed envelope system. They were divided into three groups of 25 each: group A (control) received normal saline, group B received dexmedetomidine, and group C received a combination of dexmedetomidine with dexamethasone over 10 minutes after inducing general anesthesia before skin incision. The primary outcome was to assess PONV, where nausea was assessed by the numerical rating scale and vomiting by the number of gastric content expulsions. The secondary outcome, which is postoperative sedation and pain, was assessed by the Ramsay Sedation Score and Visual Analog Score, respectively, for 24 hours postoperatively. RESULT:  During the first 24 hours after surgery, the incidence of PONV was similar in both dexmedetomidine and combination groups but lower than the control group. Postoperative sedation and analgesia were both statistically and clinically adequate and similar in dexmedetomidine and combination groups. No major side effects requiring pharmacological intervention were reported. CONCLUSION:  Dexmedetomidine alone is as effective as its combination with dexamethasone in preventing PONV in adult patients following abdominal surgeries.

Clinical and Radiographic Evaluation of Diode and Er,Cr:YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Techniques in Primary Molars: A Randomized Controlled Clinical Trial.

Background Pulpotomy treatment is one of the vital pulp therapies that can play a major role in the preservation of primary teeth until their natural exfoliation. The objective of this current clinical trial was to assess the clinical and radiographical success of diode and Er,Cr:YSGG lasers as a viable alternative to formocresol (FC) and sodium hypochlorite in the primary molar pulpotomies. Materials and methods Sixty primary molars were selected and randomly allocated to four groups. All treatment groups followed the same clinical protocol, except for the techniques used for hemostasis of the pulpotomy sites. In group A, hemostasis was achieved by applying a 1:5 dilution of FC solution, whereas in group B, 3% sodium hypochlorite was applied to achieve hemostasis. In group C, exposure to a diode laser of 940 nm was performed, whereas for group D, erbium laser irradiation with Er,Cr:YSGG laser of 2,780 nm was employed to achieve hemostasis. Radicular pulp stamps were covered with a 2 mm layer of mineral trioxide aggregate (MTA) paste. Stainless steel crowns were utilized for the final restorations of the primary teeth. The clinical and radiographic outcomes were evaluated at the six- and 12-month follow-up intervals. The investigation was registered with the ClinicalTrials.gov Protocol and Registration System (ID: NCT06002646). Results The overall clinical and radiographic success rates of pulpotomy were 92.3% for FC, 89% for sodium hypochlorite, 98.3% for a diode laser, and 98.7% for Er,Cr:YSGG lasers. There were no statistically significant differences among the four groups (p > 0.05). Conclusions Both the diode and Er,Cr:YSGG lasers showed outcomes comparable to those of FC and sodium hypochlorite. Therefore, they could be promising alternatives to primary tooth pulpotomies.

Using PRECIS-2 in Chinese herbal medicine randomized controlled trials for irritable bowel syndrome: A methodological exploration based on literature.

Background: The pragmatism levels of randomized controlled trials (RCTs) mean how similar the interventions delivered in the trial setting match those in the setting where the results will be applied. We aimed to investigate the association between the consistency of pragmatism among the characteristics of RCT design and its effect size of results in Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS). Methods: Eight English and Chinese language databases were searched for RCTs on CHM for IBS. Six reviewers independently assessed the pragmatism of trials using the pragmatic-explanatory continuum indicator summary 2 (PRECIS-2) tool. The consistency of pragmatism levels among the characteristics of RCT design was calculated using the coefficient of variation. Linear regression models were adopted to explore influence factors of the pragmatism of RCTs. Results: 78 RCTs were included. The level of consistency in the pragmatism for RCT's design was significantly correlated with the effect size of the results (binary outcome, r = -0.413; P = 0.005; continuous outcome, r = -0.779, P < 0.001). PRECIS-2 score was higher in trials with individualized interventions than fixed interventions (3.29 [0.32] vs 2.90 [0.32]; Cohen's d relative effect size, 0.52; P < 0.001) and in standard or usual-treatment-controlled trials than placebo-controlled (3.05 [0.37] vs 2.83 [0.28]; Cohen's d relative effect size, 0.32; P = 0.048). Conclusion: The consistency of pragmatism level across the 9 domains of the PRECIS-2 tool in CHM IBS RCTs was positively correlated with the effect size of the results.

Ohnut vs waitlist control for the self-management of endometriosis-associated deep dyspareunia: a pilot randomized controlled trial.

Background: Deep dyspareunia affects 50% of people with endometriosis. The Ohnut is a set of interlocking rings that fit over the penis/insertive object. One or more rings can be used to limit insertion depth and reduce deep dyspareunia. Aim: We conducted a pilot, parallel, open-label randomized controlled trial (RCT) to investigate the feasibility of the study design and the acceptability and preliminary efficacy of the Ohnut. Method: Participants were recruited from a tertiary center for endometriosis. Eligibility criteria were surgically confirmed endometriosis, age 19-49 years, monogamous sexual relationship with a partner willing to participate in the study, and no comorbid superficial dyspareunia, anxiety, or depression. Couples were randomized into an intervention group or a waitlist control group using a 1:1 allocation ratio. All couples had sex as normal during weeks 1 to 4 (baseline period), and couples in the intervention group used the Ohnut with sex during weeks 5 to 10 (intervention period) while controls had sex as normal. Patient participants used daily diaries to record sexual activity and deep dyspareunia score (0-10) for the 10-week study. Intervention group participants completed an acceptability questionnaire at the end of the study. Outcomes: The primary outcomes were feasibility of the study and acceptability of the Ohnut. We also assessed differences in deep dyspareunia scores in the participants who used the Ohnut compared to the control participants who did not. Results: We recruited approximately 5 couples per month of active recruitment. Of 864 potentially eligible participants, we successfully contacted 44.7% (n = 386), of whom 8.0% (n = 31) consented, 64.8% (n = 250) were ineligible, and 27.2% (n = 105) declined. Thirty-one couples were randomly assigned to the intervention or control group, and 17 couples completed the study. Intervention group couples used the Ohnut for an average of 72.4% (32.7%) of sexual encounters during the intervention period. The mean acceptability index score for the Ohnut was 0.83 (0.078) among patients and 0.83 (0.049) among partners (index between 0 and 1). After controlling for baseline deep dyspareunia, there was a significant difference in the intervention period mean deep dyspareunia scores between the control and intervention group (4.69 (2.44) vs 2.46 (1.82), P = .012). Clinical Implications: We identified preliminary evidence for the acceptability and efficacy of the Ohnut among both patients and partners, suggesting that the Ohnut may be a useful stand-alone or adjuvant management tool for endometriosis-associated deep dyspareunia. Strengths and Limitations: Strengths of this study were the "real-world" use of the Ohnut and data collection from both patients and partners. Limitations of the study design included the strict eligibility criteria that affected feasibility and generalizability. Conclusion: This pilot RCT indicated that the Ohnut may be an acceptable and effective intervention to reduce endometriosis-associated deep dyspareunia. We identified opportunities to improve design for a larger RCT. Clinical Trial Registration: This clinical trial was registered with clinicaltrials.gov (#NCT04370444).

Anti-IL-4Rα monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease that affects a large proportion of the global population. The treatment of CRSwNP, especially eosinophilic CRSwNP (ECRSwNP), has always been of great obstacle. Our previous phase 2 trial showed that CM310, a monoclonal antibody that targets interleukin-4 receptor alpha, was both safe and effective in reducing the size of nasal polyps, improving symptom scores, and increasing the quality of life for those with severe ECRSwNP. Objective: This phase 3 trial aims to evaluate the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of CM310 in participants with CRSwNP. Result: The CROWNS-2 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial. The study consisted of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period plus 28-week maintenance period), and a safety follow-up period (8 weeks). The study planned to enroll 180 participants with CRSwNP (at least 60% of ECRSwNP) to receive CM310 300 mg/placebo every 2 weeks (Q2W) subcutaneously for a total of 12 doses in double-blind treatment period and 300 mg CM310 Q2W subcutaneously for a total of 14 doses in maintenance period. Enrolled participants continued to use mometasone furoate nasal spray throughout the study. The primary endpoints are a change from baseline in nasal polyp score and nasal congestion score at week 24 between CM310 and placebo in both ECRSwNP and CRSwNP. Conclusion: The CROWNS-2 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical study to evaluate the efficacy and safety of CM310 in patients with CRSwNP. Trial registration: NCT05436275.

Investigating the impact of Tocilizumab, Sarilumab, and Anakinra on clinical outcomes in COVID-19: A systematic review and meta-analysis.

Background: Monoclonal antibodies (mAbs) are currently under investigation as a potential therapeutic option for COVID-19. Clinical trials are examining their efficacy in lowering mortality rates and the requirement for mechanical ventilation (MV). It is necessary to conduct a thorough examination of current randomized controlled trials (RCTs) in order to provide more definitive evidence on their effectiveness for COVID-19 patients. This meta-analysis aims to analyze RCT results on the impact of three mAbs (Anakinra, Sarilumab, Tocilizumab) on COVID-19 patient outcomes. Method: The meta-analysis was conducted in accordance with the PRISMA guidelines. Eligible RCTs were conducted to evaluate the effectiveness of three mAbs in treating patients with COVID-19. These trials were identified by searching various databases up to April 1, 2024. In total, this meta-analysis incorporated 19 trials with a total of 8097 patients. Pooled relative risk and studies' heterogeneity were assessed by statistical analysis, which involved the use of fixed effects models and subgroup analysis. Result: The administration of mAbs (Tocilizumab, Sarilumab, and Anakinra) showed various results in the management of COVID-19 patients. While the overall pooled data did not reveal a significant reduction in the need for MV, the study found that the use of mAbs was associated with a decreased risk of clinical worsening (pooled relative risk: 0.75, 95 % CI [0.59, 0.94], p = 0.01) and an increased probability of discharging COVID-19 patients by day 28 or 29 (pooled relative risk: 1.17, 95 % CI [1.10, 1.26]). Notably, the subgroup analysis revealed that Tocilizumab had a significant effect in reducing the risk of clinical worsening compared to Sarilumab. Additionally, the analysis of mortality outcomes indicated that the administration of mAbs had the potential to decrease the overall risk of mortality over time (pooled RR: 0.90, 95 % CI [0.83, 0.97], p = 0.01). Conclusion: In summary, our meta-analysis suggests that mAbs, particularly Tocilizumab, may play a valuable role in managing COVID-19 by reducing the risk of clinical worsening, improving hospital discharge rates, and decreasing mortality.

The effectiveness and sustainability of health outcomes from a holistic digital weight-loss service with concomitant initiation of tirzepatide: A pragmatic randomized controlled trial in the UK.

AIM: To measure the effectiveness and sustainability of the Juniper UK digital weight-loss service (DWLS), which delivers 6 months of personalized, proactive lifestyle coaching supplemented with tirzepatide to patients through a multidisciplinary team (MDT). METHODS: An observer-blinded randomized controlled trial (RCT) will be conducted on a cohort of non-diabetic patients of the Juniper DWLS in the UK. Participants in both the intervention and control groups will receive weekly subcutaneous injections of 2.5 mg tirzepatide for 4 weeks, uptitrating the dose to 5.0 mg from weeks 5 to 8, and by 2.5 mg every 4 weeks until reaching 15 mg in week 21, which they will maintain until the end of the intervention period at 6 months, when participants will be taken off the medication. The intervention group will receive personalized weeklylifestyle coaching with a focus on protein intake and resistance training for 6 months. Participants in the control group will attend a diet and exercise group counselling session at programme inception and will be sent a summary of the session's content at months 2 and 4. Aside from these events, health coaches will only interact with control group participants on a reactive basis. From month 6 to month 12, participants from both groups will no longer have access to their MDTs. The trial's co-primary endpoints include weight loss, fat-free to fat-mass ratio and composite strength measures at 12 months (6 months following the end of treatment), compared with baseline. Secondary endpoints include percentage change in weight, fat-free to fat-mass ratio, and composite strength from baseline to 6 months, side effect incidence, and change in cardiometabolic risk factors at 12 months. Quality of life and programme engagement represent the study's exploratory endpoints. RESULTS: A total of 688 participants enrolled in the study, with a mean age of 44.6 (± 11.4) years and a mean body mass index of 34.8 (± 7.5) kg/m2; 81.0% of participants are women, and 72.8% are of White ethnicity. More than three-quarters of participants have at least one co-morbidity, with dyslipidaemia (42.4%), hypertension (35.3%) and high cholesterol (31.8%) being the most prevalent conditions. CONCLUSIONS: This RCT will be the first to assess the effectiveness and sustainability of a real-world intensive, multidisciplinary DWLS, and it should highlight the potential of such a service for long-term obesity treatment compared with programmes that deliver standard health counselling.

Effectiveness of a nurse-led family empowerment program to improve the quality of life among pregnant adolescents: A randomized controlled trial.

OBJECTIVE: The present study examined the effects of a nurse-led family empowerment program on the quality of life of Palestinian pregnant adolescents. METHODS: This was a randomized controlled trial with a two-group pre-/post-test design. The sample consisted of 58 pregnant adolescents recruited from six governmental primary health care clinics in Palestine. Participants were randomly allocated in equal numbers to either the control group (n = 29), which received routine care, or the experimental group (n = 29), which received both routine care and the study program. Data collection instruments included a demographic form and the WHO Quality of Life-BREF (WHOQoL-BREF). Data were collected twice: at 32 or 33 weeks' gestation to establish a baseline and at 36 or 37 weeks' gestation post-test. Statistical analyses were performed and included descriptive statistics, chi-square and t-tests. RESULTS: The study findings indicated a significant increase in the mean quality of life scores of the experimental group in the post-test compared to the pre-test (P < 0.001). Additionally, pregnant adolescents in the experimental group demonstrated significantly higher post-test QoL scores than those in the control group (P < 0.001). CONCLUSION: The nurse-led family empowerment program emerges as a viable and efficacious alternative intervention for improving the quality of life among Palestinian pregnant adolescents. CLINICALTRIALS: The study was registered with the NIH U.S. National Library of Medicine ClinicalTrials.gov on 01/09/2021 with the registration code NCT05031130. It can be accessed via this link: https://classic. CLINICALTRIALS: gov/ct2/show/NCT05031130.

Evaluating analytic models for individually randomized group treatment trials with complex clustering in nested and crossed designs.

Many individually randomized group treatment (IRGT) trials randomly assign individuals to study arms but deliver treatments via shared agents, such as therapists, surgeons, or trainers. Post-randomization interactions induce correlations in outcome measures between participants sharing the same agent. Agents can be nested in or crossed with trial arm, and participants may interact with a single agent or with multiple agents. These complications have led to ambiguity in choice of models but there have been no systematic efforts to identify appropriate analytic models for these study designs. To address this gap, we undertook a simulation study to examine the performance of candidate analytic models in the presence of complex clustering arising from multiple membership, single membership, and single agent settings, in both nested and crossed designs and for a continuous outcome. With nested designs, substantial type I error rate inflation was observed when analytic models did not account for multiple membership and when analytic model weights characterizing the association with multiple agents did not match the data generating mechanism. Conversely, analytic models for crossed designs generally maintained nominal type I error rates unless there was notable imbalance in the number of participants that interact with each agent.

Effect of peanut butter supplementation on physical and cognitive functions in community-dwelling older adults: study protocol for a 6-month randomised controlled trial.

INTRODUCTION: Ageing is associated with physical and cognitive declines, which may be further exacerbated by poor nutrition. Nuts are energy and nutrient dense, and their consumption is associated with better physical and cognitive functions in older adults, but data from interventional studies are limited. This 6-month randomised controlled trial is designed to investigate the effects of consuming 43 g/day of peanut butter (equivalent to 1.5 servings of nuts) on physical function, including walking speed (primary outcome), standing and dynamic balance, upper and lower body strength, lower body power and endurance, and associated factors including muscle mass, cognitive function and DNA telomere length in community-dwelling older adults. METHOD AND ANALYSIS: A total of 120 participants aged ≥65 years will be recruited and randomly allocated (1:1 ratio) to either the intervention group (n=60) that will receive individually packaged sealed containers containing 43 g of peanut butter to be consumed once daily for 6 months alongside habitual diet, or the control group (n=60) that will maintain their habitual diet. Primary and secondary outcomes will be assessed at baseline and at 6 months. The primary outcome is walking speed assessed using the 4 m usual gait speed test. Secondary outcomes include other physical function assessments: standing balance, chair stand time, timed-up-and-go test and four-square step test; and hand grip and knee extensor muscle strength; cognitive function assessed using the Montreal Cognitive Assessment and trail making tests; body composition; nutritional status; and DNA telomere length from participants' buccal cell samples. Linear mixed models will be used to compare changes in outcomes between intervention and control groups. ETHICS AND DISSEMINATION: The study protocol is approved by the Deakin University Human Research Ethics Committee. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622001291774. The results will be disseminated through peer-reviewed journals, conference presentations and media. TRIAL REGISTRATION NUMBER: ANZCTR12622001291774.

Cost-effectiveness analysis of app-delivered self-management support (selfBACK) in addition to usual care for people with low back pain in Denmark.

OBJECTIVES: This study aims to investigate the cost-effectiveness of individually tailored self-management support, delivered via the artificial intelligence-based selfBACK app, as an add-on to usual care for people with low back pain (LBP). DESIGN: Secondary health-economic analysis of the selfBACK randomised controlled trial (RCT) with a 9-month follow-up conducted from a Danish national healthcare perspective (primary scenario) and a societal perspective limited to long-term productivity in the form of long-term absenteeism (secondary scenario). SETTING: Primary care and an outpatient spine clinic in Denmark. PARTICIPANTS: A subset of Danish participants in the selfBACK RCT, including 297 adults with LBP randomised to the intervention (n=148) or the control group (n=149). INTERVENTIONS: App-delivered evidence-based, individually tailored self-management support as an add-on to usual care compared with usual care alone among people with LBP. OUTCOME MEASURES: Costs of healthcare usage and productivity loss, quality-adjusted life-years (QALYs) based on the EuroQol-5L Dimension Questionnaire, meaningful changes in LBP-related disability measured by the Roland-Morris Disability Questionnaire (RMDQ) and the Pain Self-Efficacy Questionnaire (PSEQ), costs (healthcare and productivity loss measured in Euro) and incremental cost-effectiveness ratios (ICERs). RESULTS: The incremental costs were higher for the selfBACK intervention (mean difference €230 (95% CI -136 to 595)), where ICERs showed an increase in costs of €7336 per QALY gained in the intervention group, and €1302 and €1634 for an additional person with minimal important change on the PSEQ and RMDQ score, respectively. At a cost-effectiveness threshold value of €23250, the selfBACK intervention has a 98% probability of being cost-effective. Analysis of productivity loss was very sensitive, which creates uncertainty about the results from a societal perspective limited to long-term productivity. CONCLUSIONS: From a healthcare perspective, the selfBACK intervention is likely to represent a cost-effective treatment for people with LBP. However, including productivity loss introduces uncertainty to the results. TRIAL REGISTRATION NUMBER: NCT03798288.

The influence of different intensity of Tan Tui exercises on the posture control of students in the Tai Chi Elective Course: protocol for a randomized controlled trial.

BACKGROUND: Tai Chi (TC) holds a unique and valued place in promoting the physical and mental health of college students. Its significance is underscored by its incorporation as a compulsory physical education course in every university in China. TC, with its rich tradition, places a strong emphasis on posture control as a core sports ability. However, the students in Tai Chi Elective Course (TCEC) have very poor posture control ability. This study protocol investigates the potential of Tan Tui (TT) to address these issues, as TT is a fundamental skill for beginners of traditional Chinese martial arts and has a track record of enhancing lower limb strength and balance, making it a promising choice for improving posture control in TCEC. METHODS/DESIGN: To investigate the impact of different intensities of TT exercises on posture control in TCEC students, we have designed a randomized, double-blind, parallel-controlled trial. Seventy-six students in the TCEC will be randomly divided into low-intensity Tan Tui (LTT), medium-intensity Tan Tui (MTT), and high-intensity Tan Tui exercises group (HTT) and control group (CON), each with 19 people. The LTT group, MTT group, and HTT group will be given different intensity of TT exercises, and the CON group will be given regular TCEC. The intervention period will be 6 weeks (2 times a week, 20 min each time). At baseline (before), 4 weeks of intervention (middle), and 6 weeks of intervention (after), the Unipedal Stance Test (UST), the Star Excursion Balance Test (SEBT), 60°/s angular velocity knee joint flexion and extension relative peak torque (RPT), and knee joint position perception (KJPP) will be evaluated. DISCUSSION: This is the first randomized controlled trial protocol from the perspective of training intensity to evaluate the effect of different intensity of TT exercises on posture control of students in TCEC. Should our research reveal a significant intervention effect, the results will offer preliminary, higher-quality evidence supporting the positive impact of varying intensities of Tan Tui exercises on posture control in TCEC students. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000039109. Registered on October 17, 2020.

Effectiveness of WhatsApp based debunking reminders on follow-up visit attendance for individuals with hypertension: a randomized controlled trial in India.

BACKGROUND: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. METHODS: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. RESULTS: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). CONCLUSIONS: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. TRIAL REGISTRATION: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35].

A Meta-Analysis of 3-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small-Vessel Coronary Artery Disease.

Background: Drug-coated balloons (DCBs) may be a viable alternative to drug-eluting stents (DES) for de novo small caliber coronary artery lesions. However, there remains a lack of data regarding the long-term efficacy of this approach. Objectives: The purpose of this study was to compare the rates of major adverse cardiovascular events (MACE) after 3-year follow-up among patients randomized to DCB versus DES for the treatment of small caliber coronary arteries with reference vessel diameter between 2 and 3 mm. Methods: We systematically searched MEDLINE, EMBASE, and CENTRAL databases from their inception to July 2023 for randomized controlled trials comparing DCB versus DES for small caliber coronary artery disease. The primary end point was MACE at 3-year follow-up. Risk of bias was assessed using the Cochrane Risk of Bias Tool (RoB 2). Pooled risk ratios (RRs) and 95% CIs were estimated using random effects meta-analytic models. Results: Four randomized controlled trials (n = 1,402) were included. In total, 706 patients were randomized to DCB and 696 to DES. Participants were mostly male (74%), with a mean/median age ranging from 60 to 68 years. Pooled data across trials for MACE showed wide CIs, with little indication of DES superiority over DCB (RR: 0.71; 95% CI: 0.36-1.41). Most individual components of MACE were inconclusive. There was a potential signal for a reduction of target vessel thrombosis with DCB compared to DES (RR: 0.25; 95% CI: 0.06-1.08). Conclusions: Although sample sizes are small, 3-year outcomes suggest that DCB may be a reasonable alternative to DES for the treatment of small coronary arteries.

Efficacy of Save Medical Corporation (SMC)-01, a Smartphone App Designed to Support Type 2 Diabetes Self-Management Based on Established Guidelines: Randomized Controlled Trial.

BACKGROUND: Lifestyle modifications are a key part of type 2 diabetes mellitus treatment. Many patients find long-term self-management difficult, and mobile apps could be a solution. In 2010, in the United States, a mobile app was approved as an official medical device. Similar apps have entered the Japanese market but are yet to be classified as medical devices. OBJECTIVE: The objective of this study was to determine the efficacy of Save Medical Corporation (SMC)-01, a mobile app for the support of lifestyle modifications among Japanese patients with type 2 diabetes mellitus. METHODS: This was a 24-week multi-institutional, prospective randomized controlled trial. The intervention group received SMC-01, an app with functions allowing patients to record data and receive personalized feedback to encourage a healthier lifestyle. The control group used paper journals for diabetes self-management. The primary outcome was the between-group difference in change in hemoglobin A1c from baseline to week 12. RESULTS: The change in hemoglobin A1c from baseline to week 12 was -0.05% (95% CI -0.14% to 0.04%) in the intervention group and 0.06% (95% CI -0.04% to 0.15%) in the control group. The between-group difference in change was -0.11% (95% CI -0.24% to 0.03%; P=.11). CONCLUSIONS: There was no statistically significant change in glycemic control. The lack of change could be due to SMC-01 insufficiently inducing behavior change, absence of screening for patients who have high intention to change their lifestyle, low effective usage of SMC-01 due to design issues, or problems with the SMC-01 intervention. Future efforts should focus on these issues in the early phase of developing interventions. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCT2032200033; https://jrct.niph.go.jp/latest-detail/jRCT2032200033.

Effect of Hospital-to-Home Transitional Care for COPD on Patient-Centered Outcomes.

BACKGROUND: Appropriate hospital-to-home transitional care has been recognized for its positive impact on health care usage and health outcomes in patients with COPD. However, there is limited research assessing its effects on patient-centered outcomes, focusing on patient symptoms and experiences. METHODS: This single-blind randomized controlled trial included subjects diagnosed with COPD at one of 2 university hospitals in South Korea. The study included 179 subjects (transitional care group [transitional care], 87; usual care group [usual care], 92). The transitional care received transitional care comprising post-discharge care planning, personalized education, breathing exercises, telephone counseling, home visits, and referral to social services. We analyzed the effects of these interventions by comparing breathing symptoms and various patient-centered outcomes between the 2 groups. RESULTS: The Modified Medical Research Council scores (mean [SD], transitional care 1.3 [1.06], usual care 1.82 [1.1], P = .002) and COPD Assessment Test scores (transitional care 6.32 [5.5], usual care 9.43 [7.16], P = .001) in the intervention group demonstrated more significant improvement than did those in the usual care. Following intervention, the subjects exhibited enhanced awareness of their disease, an increased frequency of inhaler use (transitional care 49.69 [1.67], usual care 46.86 [7.92], P = .002), and lower depression and anxiety scores. Additionally, the transitional care outperformed the usual care in the domain of subject experience during hospitalization (transitional care 39.34 [6.14], usual care 37.5 [5.61], P = .036), preparedness before discharge (transitional care 34.54 [4.96], usual care 32.3 [5.09], P = .003), and post-discharge management (transitional care 34.72 [4.36], usual care 30.29 [4.26], P = .003). CONCLUSIONS: Evidence-based transitional care services can exert positive effects on patient-centered indices. Our findings can be used as evidence of the need to establish patient-centered transitional care as a form of universal care for patients with COPD.

The impact of a small-group mammography video discussion on promoting screening uptake among nonadherent Chinese American immigrant women: A randomized controlled trial.

BACKGROUND: The objective of this study was to evaluate the efficacy of an in-person, small-group mammography video discussion (SMVD) intervention on mammography uptake among nonadherent Chinese American immigrant women. METHODS: Women (N = 956) were randomized into either an SMVD group, where Chinese-speaking community health workers (CHWs) used an effective, culturally appropriate video to discuss mammography, or a video-only group, which viewed the cultural video sent by mail. Outcomes were mammography uptake at 6 months and 21 months postintervention. RESULTS: Women in both groups increased mammography uptake, and an outcome analysis revealed no group differences (adjusted odds ratio [AOR], 1.18; 95% confidence interval [CI], .68-2.06). Overall, 61.2% of the SMVD group and 55.3% of the video-only group had at least one mammogram during the 21-month follow-up period. When considering attendance to the SMVD, SMVD attendees had higher mammography uptake than the video-only group (AOR, 1.51; 95% CI, 1.19-1.92), and SMVD nonattendees had lower mammography uptake than the video-only group (AOR, .33; 95% CI, .22-.50). CONCLUSIONS: Both intervention strategies were associated with increased mammography uptake. The authors observed that the increase in use was greater among women who participated in the SMVD session compared with those who viewed the cultural video only. Future research may explore a virtual SMVD intervention for higher session attendance and increased mammography uptake (ClinicalTrials.gov identifier NCT01292200).

Manual therapy plus sexual advice compared with manual therapy or exercise therapy alone for lumbar radiculopathy: a randomized controlled trial.

CONTEXT: The biopsychosocial approach to managing low back pain (LBP) has the potential to improve the quality of care for patients. However, LBP trials that have utilized the biopsychosocial approach to treatment have largely neglected sexual activity, which is an important social component of individuals with LBP. OBJECTIVES: The objectives of the study are to determine the effects of manual therapy plus sexual advice (MT+SA) compared with manual therapy (MT) or exercise therapy (ET) alone in the management of individuals with lumbar disc herniation with radiculopathy (DHR) and to determine the best sexual positions for these individuals. METHODS: This was a single-blind randomized controlled trial. Fifty-four participants diagnosed as having chronic DHR (>3 months) were randomly allocated into three groups with 18 participants each in the MT+SA, MT and ET groups. The participants in the MT+SA group received manual therapy (including Dowling's progressive inhibition of neuromuscular structures and Mulligan's spinal mobilization with leg movement) plus sexual advice, those in the MT group received manual therapy only and those in the ET group received exercise therapy only. Each group received treatment for 12 weeks and then followed up for additional 40 weeks. The primary outcomes were pain, activity limitation, sexual disability and kinesiophobia at 12 weeks post-randomization. RESULTS: The MT+SA group improved significantly better than the MT or ET group in all outcomes (except for nerve function), and at all timelines (6, 12, 26, and 52 weeks post-randomization). These improvements were also clinically meaningful for back pain, leg pain, medication intake, and functional mobility at 6 and 12 weeks post-randomization and for sexual disability, activity limitation, pain catastrophizing, and kinesiophobia at 6, 12, 26, and 52 weeks post-randomization (p<0.05). On the other hand, many preferred sexual positions for individuals with DHR emerged, with "side-lying" being the most practiced sexual position and "standing" being the least practiced sexual position by females. While "lying supine" was the most practiced sexual position and "sitting on a chair" was the least practiced sexual position by males. CONCLUSIONS: This study found that individuals with DHR demonstrated better improvements in all outcomes when treated with MT+SA than when treated with MT or ET alone. These improvements were also clinically meaningful for sexual disability, activity limitation, pain catastrophizing, and kinesiophobia at long-term follow-up. There is also no one-size-fits-all to sexual positioning for individuals with DHR.

Articulated ankle-foot orthoses associated with home-based task-specific training improve functional mobility in patients with stroke: a randomized clinical trial.

INTRODUCTION: We compared fixed and articulated ankle-foot orthoses (AFOs) in home-based mobility tasks to assess short-term mobility, dynamic balance, quality of life, anxiety/depression, disability level, stroke severity, autonomy, human functioning, and patient satisfaction. METHODS: This was a two-arm, parallel-group, randomized controlled trial with concealed allocation, assessor blinding, and a complete case analysis involving patients with chronic stroke. The participants were randomized into two groups: fixed (n = 24) and articulated (n = 23) AFOs. The AFOs were custom-fabricated, and both groups performed four-week home-based mobility tasks five days weekly. Primary outcome measures included changes in balance and mobility assessed using the Tinetti Performance-Oriented Mobility Assessment (POMA), Timed Up and Go (TUG) test, and Functional Ambulation Category (FAC). Secondary outcomes included quality of life, anxiety/depression, disability, stroke severity, autonomy, human functioning, and patient satisfaction. RESULTS: In a between-group comparison, after adjusting for age, sex, stroke severity, and thrombolysis, the articulated AFO group showed better performance in the TUG test (p = 0.020; d = 0.93), POMA-Gait (p = 0.001; d = 0.53), POMA-Total (p = 0.048; d = 0.98), and FAC (p = 0.003; d = 1.03) than the fixed AFO group. Moreover, significant difference was noted in human functioning (moving around using equipment)between the groups (p = 0.047; d = 92). CONCLUSION: A program involving home-based mobility tasks and articulated AFOs improved functional mobility after stroke.