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Background: One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques. Method: Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery. Results: Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups. Conclusions: %EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB. Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT02601092. [ABSTRACT FROM AUTHOR]

The study aimed to compare the effectiveness of a traditional cardiac rehabilitation (CR) program with an enhanced program incorporating the model of therapeutic engagement (MTE) and extended remote support for patients undergoing coronary artery bypass graft (CABG) patients. In a randomized controlled trial, 88 CABG patients were assigned to experimental and control groups. The experimental group received integrated MTE cardiac rehabilitation, and assessments were conducted at three time points: pre-CR, one month later, and three months post-CR. The study measured medication adherence (MARS-5) and sense of coherence (SoC-13) scales. The study found no significant differences in demographic factors between the experimental and control groups. However, significant differences were observed in MARS and individuals' SoC scores over time in the experimental group, with notable improvements (p < 0.001). The control group showed significant changes only up to one month. Group effects were evident, with consistent increases in the experimental group's outcomes at each assessment point. Integrating the MTE into CR programs offers benefits in terms of medication adherence and individuals' sense of coherence, which warrants further investigation and clinical implementation. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs). This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program. The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes. This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Background and aims: Pre‐clinical studies suggest that the simultaneous blockade of the α1b and 5HT2A receptors may be effective in reducing alcohol consumption. This study aimed to assess the efficacy and safety of prazosin (α1b blocker) and cyproheptadine (5HT2A blocker) combination in decreasing total alcohol consumption (TAC) in alcohol use disorder (AUD). Design, setting and participants: This was a double‐blind, parallel group, placebo‐controlled, Phase 2, randomized clinical trial conducted in 32 addiction treatment centres in France. A total of 108 men and 46 women with severe AUD took part. Intervention: Participants were randomly assigned to one of the following 3‐month treatments: (1) low‐dose group (LDG) receiving 8 mg cyproheptadine and 5 mg prazosin extended‐release (ER) formulation daily; (2) high‐dose group (HDG) receiving 12 mg cyproheptadine and 10 mg prazosin ER daily; and (3) placebo group (PG) receiving placebo of cyproheptadine and prazosin ER. A total of 154 patients were randomized: 54 in the PG, 54 in the LDG and 46 in the HDG. Measurements The primary outcome was TAC change from baseline to month 3. Findings: A significant main treatment effect in the change in TAC was found in the intent‐to‐treat population (P = 0.039). The HDG and LDG showed a benefit in the change in TAC from baseline to month 3 compared with PG: −23.6 g/day, P = 0.016, Cohen's d = −0.44; −18.4 g/day, P = 0.048 (Bonferroni correction P < 0.025), Cohen's d = −0.36. In a subgroup of very high‐risk drinking‐level participants (> 100 g/day of pure alcohol for men and > 60 g/day for women), the difference between the HDG and the PG in the primary outcome was −29.8 g/day (P = 0.031, Cohen's d = −0.51). The high and low doses were well‐tolerated with a similar safety profile. Conclusions: A randomized controlled trial of treatment of severe alcohol use disorder with a cyproheptadine−prazosin combination for 3 months reduced drinking by more than 23 g per day compared with placebo. A higher dose combination was associated with a larger magnitude of drinking reduction than a lower dose combination while showing similar safety profile. [ABSTRACT FROM AUTHOR]

Aim: To systematically identify, synthesize and critically summarize the available scientific evidence from randomized controlled trials (RCTs) regarding whether short (≤6 mm) perform as well as long (≥10 mm) implants regarding implant survival, marginal bone loss, and biologic and prosthetic complications in different clinical scenarios. Materials and Methods: Cochrane Collaboration's risk of bias tool and the GRADE approach were applied. Results were synthesized using random‐effects meta‐analyses assessed by trial sequential analyses. Results: Forty reports on 19 RCTs comprising 2214 (1097 short; 1117 long) implants were included. Moderate/high certainty/quality evidence demonstrated similar 5‐year survival rates for ≤6‐mm and ≥10‐mm implants in non‐augmented bone and full‐mouth rehabilitation in either jaw, and for 6‐mm implants in the maxilla instead of sinus lift. Nevertheless, the evidence for 5‐year survival rates remains inconclusive or insufficient for the remaining combinations of implant lengths and clinical scenarios. They include 4‐mm and 5‐mm implants as alternatives to sinus lift as well as placing all implant lengths ≤6 mm instead of vertical ridge augmentation with long implants. Marginal bone level and short‐ and long‐term biologic or prosthetic complications were similar. Conclusions: Based on moderate/high certainty/quality evidence from 5‐year RCTs, implants ≤6 mm may be viable alternatives to ≥10‐mm implants in either jaw in native bone and full‐arch rehabilitation, and 6‐mm implants may be used as an alternative to sinus lift. Trial registration: PROSPERO ID: CRD42021254365. [ABSTRACT FROM AUTHOR]

Background: Periprosthetic joint infection after total joint arthroplasty has a large incidence, and it may often require two or more stages of revision, placing an additional burden on clinicians and patients. The purpose of this network meta-analysis is to evaluate the effect of four different preventive strategies during total joint arthroplasty on the prevention of periprosthetic joint infection. Methods: The study protocol was registered at PROSPERO (CRD: 42,023,448,868), and the literature search databases included Web of Science, PubMed, OVID Cochrane Central Register of Controlled Trials, OVID EMBASE, and OVID MEDLINE (R) ALL that met the requirements. The network meta-analysis included randomized controlled trials, retrospective cohort studies and prospective cohort studies with the outcome of periprosthetic joint infection. The gemtc R package was applied to perform the network meta-analysis to evaluate the relative results of different preventive strategies. Results: This network meta-analysis study included a total of 38 articles with 4 preventive strategies and negative controls. No improvement was observed in antibiotic-loaded bone cement compared with negative controls. Chlorhexidine showed the highest probability of delivering the best preventive effect, and povidone iodine had the second highest probability. Although vancomycin ranked after chlorhexidine and povidone iodine, it still showed a significant difference compared with negative controls. In addition, the incidence after applying chlorhexidine was significantly lower than that after applying negative controls and vancomycin. In the heterogeneity test between direct and indirect evidence, there was no apparent heterogeneity between them. Conclusion: The study indicated that chlorhexidine, povidone iodine and vancomycin showed significant efficacy in preventing periprosthetic joint infection after total joint arthroplasty, while antibiotic-loaded bone cement did not. Therefore, more high-quality randomized controlled trials are needed to verify the results above. [ABSTRACT FROM AUTHOR]

Background: Veterans have a high prevalence of opioid prescriptions to manage chronic low back pain (CLBP), resulting in increased risk of becoming addicted and overdosing. It is important to identify effective and safe mind–body interventions to reduce opioid use for veterans with CLBP. Qigong, a mind–body therapy, is a promising approach to manage CLBP in veterans. This study assessed the feasibility and acceptability of qigong and examined whether pain is reduced after a qigong intervention. Methods: In this randomized controlled trial, 31 participants were randomized to the qigong intervention (n = 15) or a wait-list control group (WLCG; n = 16). The qigong intervention was conducted twice weekly in 45-minute sessions for 8 weeks (total of 16 sessions). Participants who completed the qigong intervention were invited to participate in a focus group conducted through videoconferencing. In addition to assessing feasibility and acceptability of the qigong intervention, pain intensity, pain interference, and low back pain and disability were measured at baseline and postintervention. Results: Qigong is a feasible intervention for veterans with CLBP, based on retention (83%), attendance (70%), and fidelity (100%), with no injury or other adverse events. Qigong was acceptable to the veterans with CLBP, who reported that they would continue to practice qigong to manage CLBP for long-term effects. Statistically significant differences in reduction in pain intensity (p =.047), pain interference (p =.04), and pain-related disability (p =.028) between the qigong group and WLCG from baseline to postintervention were identified. Conclusion: Qigong is a mind–body approach to manage CLBP in veterans who receive care through the Veterans Health Administration and in the community. For future studies, a larger sample would provide a higher level of empirical evidence to support qigong practice for CLBP in veterans. Future studies should assess sustainability of the intervention. [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Background: There is inconsistent utilisation of clinical practice guidelines (CPGs) for cardiovascular disease (CVD) screening and management by healthcare professionals to identify CVD risk factors early and to intervene using current recommendations. To address this issue, the Cardiovascular Assessment Screening Program (CASP) was developed, implemented, and evaluated. This manuscript reports on the second phase of an exploratory sequential mixed methods study that tested the effectiveness of the CASP with nurse practitioners (NPs) and patients in Canada. Methods: A two-armed, non-blinded, cluster randomised controlled trial (cRCT) compared the NP-led implementation of CASP with usual care by NPs in community practice clinics across one Canadian province. The NPs were the cluster variable as their screening practices could be affected by their educational training, resources, or other factors. NPs were eligible for inclusion in the study if they were located in different urban and rural community settings and could conduct follow-up visits with patients. NPs recruited and enrolled the patients from their own practices as participants if they were healthy individuals, aged 40–74 years, with no established CVD or vascular disease. Researchers randomly allocated the NPs (n = 10) to the intervention group (IG) or the control group (CG). Results: Eight (8) NPs and 167 patients participated in the cRCT study. Patient participant-level data were analysed by the originally assigned groups IG (n = 68) and CG (n = 99). Utilising GLM (generalized linear modeling) more IG patients (90%; n = 61) received comprehensive CVD screening compared to the CG patients (2%; n = 2), RR = 30.2, 95% CI [8.76, 103.9], p <.0001, controlling for the effect of NP and BP category. Conclusion: NP implementation of CASP was effective for comprehensive screening compared to usual care and led to identifying previously unknown CVD risk factors, calculated FRS, heart health priorities and personalised goal-setting. Trial registration: ClinicalTrial.gov ID#: NCT03170752, date of registration 2017/05/31. [ABSTRACT FROM AUTHOR]

Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate whether attentional control serves as a mediator for mindfulness‐based interventions for emotional distress, utilizing a randomized waitlist (WL)‐controlled design. Methods: A total of 498 participants with high emotional distress was recruited online and randomly assigned to a 49‐day online Mindfulness Intervention for Emotional Distress (MIED) group (N = 249) or a WL control group (N = 249). Levels of attentional control, anxiety and depression were assessed at baseline (T0), Week 3 (T3), Week 5 (T5) and Week 7 (postintervention, T7). Results: Linear mixed models revealed significant Group‐by‐Time interaction effects for attentional control (p < 0.001), anxiety (p < 0.001) and depression (p < 0.05). Latent growth curve analyses demonstrated a significant increase in attentional control and a decrease in anxiety and depression levels during the MIED programme. These changes becoming evident starting Week 3. Longitudinal mediation analyses revealed that the slope of attentional control significantly mediated the effects of the MIED programme on the slope of anxiety and depression levels. Further, attentional control level at Week 3 significantly mediates the effect of MIED programme on anxiety and depression levels at Weeks 5 and 7. Similarly, attentional control level at Week 5 significantly mediates the MIED programme's effects on anxiety and depression levels at Week 7. Conclusions: The present trial provides evidence suggesting that mindfulness interventions may alleviate emotional distress through the enhancement of attentional control. Trial Registration: Chinese Clinical Trial Registry number: ChiCTR2200064140 [ABSTRACT FROM AUTHOR]

Simple Summary: Head and neck cancer is associated with significant morbidity. Shoulder and neck dysfunction, weight loss, and declines in muscular strength and physical functioning are commonly seen following cancer therapies. This pragmatic randomized controlled trial involved sixty-one individuals with cancer in the head and neck region who had completed their cancer treatment. The primary aim was to assess the effectiveness of the addition of lower-body resistance exercise training to a physiotherapeutic shoulder and neck exercise protocol on fatigue-related quality of life. Findings support the benefit of the combined intervention for fatigue-related quality of life, six-minute walk test distance, upper- and lower-body muscular strength, and physical activity level. The continued improvement in treatment effect over the one-year follow-up period suggests promise from this interdisciplinary approach to bridge individuals with head and neck cancer from rehabilitation care to general exercise and physical activity. Background: Established barriers to general exercise and physical activity among individuals with head and neck cancer include dry mouth, difficulty eating, weight loss, fear of injury, comorbidities, and treatment-related symptoms of pain and fatigue. Methods/Design: A 12-week pragmatic randomized controlled trial was conducted followed by an optional supported exercise transition phase. Eligible participants were individuals with head and neck cancers who had undergone surgery and/or radiation therapy to lymph node regions in the neck. Participants were randomized to a comparison group involving a shoulder and neck physiotherapeutic exercise protocol, or to a combined experimental group comprising the shoulder and neck physiotherapeutic exercise protocol and lower-body resistance exercise training. The primary outcome of this study was fatigue-related quality of life. Results: Sixty-one participants enrolled, 59 (97%) completed the randomized trial phase, 55 (90%) completed the 24-week follow-up, and 52 (85%) completed the one-year follow-up. Statistically significant between-group differences were found in favor of the combined experimental group for the fatigue-related quality of life, fitness outcomes, and overall physical activity. Paired comparisons confirmed significant within-group improvements for both groups from baseline to one-year follow-up across most outcomes. Discussion: A group-based combined physiotherapeutic and lower-body resistance exercise program was feasible and effective. Findings are limited to individuals who had undergone a surgical neck dissection procedure. Given the complexity of head and neck cancer, further pragmatic interdisciplinary research is warranted. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Background: The purpose of the present study was to systematically delve into the efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) on the quality of recovery after general anesthesia. Methods: Randomized controlled trials related to TEAS improving postoperative recovery quality were searched in Cochrane Library, Web of Science, Embase, PubMed, CNKI, VIP, Wanfang and Chinese biomedical database from the inception of each database to June 2023. After literature screening and data extraction, Stata15 software was employed for meta-analysis, and the quality of the included literature was evaluated utilizing ROB2. Results: The study included 10 articles involving 2,383 patients in total. The meta-analysis results unveiled that TEAS could improve 24-hour and 48-hour postoperative QoR-40 scores as well as 24-hour postoperative QoR-40 dimension scores [WMD = 8.52, 95%CI (5.12, 11.91), P < 0.001; WMD = 1.99, 95%CI (0.91, 3.07), P < 0.001], emotional state [WMD = 1.38, 95%CI (0.66, 2.09), P < 0.001], physical comfort [WMD = 2.99, 95%CI (1.59, 4.39), P < 0.001], psychological support [WMD = 0.63, 95%CI (0.36, 0.90), P < 0.001], and physical independence [WMD = 0.76, 95%CI (0.22, 1.30), P = 0.006]; pain [WMD = 1.81, 95%CI (0.87, 2.75), P < 0.001]; decrease 24-hour postoperative VAS pain scores [WMD = -0.84, 95%CI (-1.45, -0.23), P = 0.007] and the incidence of postoperative nausea and vomiting [RR = 0.88, 95%CI (0.81, 0.97), P = 0.006; RR = 0.62, 95%CI (0.52, 0.73), P < 0.001]. Conclusion: TEAS can improve postoperative QoR-40 scores and the quality of recovery, relieve pain, and decrease the incidence of nausea and vomiting after surgery in patients who underwent general anesthesia. Trial registration: CRD42023433959. [ABSTRACT FROM AUTHOR]

Objectives To assess eligibility criteria that either explicitly or implicitly exclude older patients from randomized controlled trials (RCTs) in RA. Methods Our analysis included RCTs of pharmacological interventions registered with ClinicalTrials.gov and started between 2013 and 2022. Co-primary outcomes were proportions of trials with an upper age limit and the eligibility criteria indirectly increasing risk of the exclusion of older adults. Results A total of 143/290 (49%) trials had an upper age limit of 85 years or less. Multivariable analysis showed that the odds of an upper age limit were significantly lower in trials performed in the USA [adjusted odds ratio (aOR), 0.34; CI, 0.12–0.99; P  = 0.04] and intercontinental trials (aOR, 0.4; CI, 0.18–0.87; P  = 0.02). In total, 154/290 (53%) trials had at least one eligibility criterion implicitly excluding older adults. These included specific comorbidities (n  = 114; 39%), compliance concerns (n  = 67; 23%), and broad and vague exclusion criteria (n  = 57; 20%); however, we found no significant associations between these criteria and trial characteristics. Overall, 217 (75%) trials either explicitly or implicitly excluded older patients; we also noted a trend towards increasing proportion of these trials over time. Only one trial (0.3%) enrolled solely patients aged 65 and older. Conclusion Older adults are commonly excluded from RCTs in RA based on both age limits and other eligibility criteria. This seriously limits the evidence base for the treatment of older patients in clinical practice. Given the growing prevalence of RA in older adults, relevant RCTs should be more inclusive to them. [ABSTRACT FROM AUTHOR]

Paretic side collisions frequently occur in stroke patients, especially while walking through narrow spaces. We determined whether training for walking through an opening (T-WTO) while entering from the paretic side would improve collision avoidance behavior and prevent falls after 6 months. Thirty-eight adults with moderate-to-mild hemiparetic gait after stroke who were hospitalized in a rehabilitation setting were randomly allocated to the T-WTO (n = 20) or regular rehabilitation (R-Control; n = 18) program. Both groups received five sessions of 40 min per week, for three weeks total. T-WTO included walking through openings of various widths while rotating with the paretic side in front, and R-Control involved normal walking without body rotation. Obstacle avoidance ability, 10-m walking test, timed Up and Go test, Berg Balance Scale, Activities-specific Balance Confidence, the perceptual judgment of passability, and fall incidence were assessed. Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrast, T-WTO did not lead to significant improvements in other outcomes. T-WTO improved efficiency and safety in managing subacute stroke patients. Such training could improve patient outcomes/safety because of the paretic body side during walking. R000038375 UMIN000033926 Individuals with stroke often collide with the paretic side while walking through narrow spaces. Training for walking through a narrow opening from the paretic side improved an individual's ability to avoid obstacles in similar tasks. Moreover, such training could improve patient outcomes/safety because such interventions may temporarily increase attentional focus to the paretic side in specific tasks. [ABSTRACT FROM AUTHOR]

Background: To evaluate the efficacy and safety of Keluoxin (KLX) capsules and provide validated evidence for the application of KLX in the treatment of diabetic kidney disease (DKD). Methods: A multicenter, randomized, double-blind, placebo-controlled trial design was used to screen 129 patients with DKD (urinary albumin-to-creatinine ratio [UACR]: male, 2.5–30 mg/mmol; female, 3.5–30 mg/mmol) and with Qi and Yin deficiency and blood stasis symptoms. Written informed consent was obtained from all patients. The patients were randomly divided into KLX and control groups. The KLX group was orally administered KLX (6 g/day) and irbesartan tablets (150 mg/day), whereas the control group was administered KLX placebo (6 g/day) and irbesartan tablets (150 mg/day). Patients were observed for 24 weeks to evaluate the natural logarithm of the UACR (log-UACR), the odds ratio (OR) for a sustained increase in the UACR of at least 30% and 40%, estimated glomerular filtration rate (eGFR), changes in symptoms and quality–of-life scores, and adverse events. Results: The changes of the natural log-UACR during the 24 weeks compared with baseline in the KLX group were better than those in the control group (LS mean ± standard error, −0.26 ± 0.10 vs. 0.01 ± 0.09, p = 0.0292). The incidence of a sustained increase in the UACR of at least 30% and 40% was found to be significantly lower in the KLX group (OR, 0.26; 95% confidence interval [CI], 0.09–0.75; OR, 0.29; 95% CI, 0.10–0.82). Changes in symptoms and quality-of-life scores in the KLX group were better than those in the control group. There was no statistically significant difference in eGFR or the incidence of adverse events between the groups. Conclusions: Overall, these results suggest that KLX capsules combined with irbesartan can reduce microalbuminuria, relieve the symptoms, and improve the quality of life for patients with type 2 early DKD compared with the use of irbesartan alone. Trial registration: Chinese Clinical Trial Registry, registration number: ChiCTR2100052764. [ABSTRACT FROM AUTHOR]

Background: Intensive care unit (ICU) patients often experience significant physiological stress. This study evaluated the effect of a defined family visitation protocol on physiological responses in the ICU. Methods: A randomized, block-randomized clinical trial was conducted on 78 ICU patients at Imam Reza Hospital between February 8, 2017, and August 8, 2017. The intervention group received protocol-based visits, and the control group continued with standard visitation. Block randomization was utilized for group assignments. The primary outcome was the measurement of physiological signs using designated monitoring devices. Data were analyzed using SPSS version 22, employing independent t-tests, Mann-Whitney U test, repeated measures analysis, and Friedman's test. Results: The results showed no significant differences in systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, and arterial blood oxygen levels between the two groups. However, heart rate in the intervention group was significantly lower in three stages before, during, and after the meaningful visiting (P = 0.008). Conclusion: Protocol-based scheduled family visits in the ICU may reduce physiological stress, as evidenced by a decrease in patients' heart rate. Implementing tailored visitation protocols sensitive to patient preferences and clinical contexts is advisable, suggesting the integration of family visits into standard care practices for enhanced patient outcomes. Trial Registration: IRCT20161229031654N2; 25/01/2018; Iranian Registry of Clinical Trials (https://en.irct.ir). [ABSTRACT FROM AUTHOR]

Purpose: This study compared the effectiveness of age‐appropriate, high technology, interactive virtual reality (VR) distraction with standard care (SC) provided by the nurse on adolescents' acute procedural pain intensity perception during burn wound care treatment in the ambulatory clinic setting. Design: This randomized controlled trial included 43 adolescents ages 10–21 from the ambulatory burn clinic of a large children's hospital. Methods: Blinded study participants were randomly assigned to either VR or SC (non‐significantly different, current mean burn surface area, 1.3 and 1.7, respectively) during the first burn wound care procedure in the burn clinic. Blinded research staff collected pre‐procedure data including Spielberger's State‐Trait Anxiety Inventory and postprocedure wound care pain intensity using the Adolescent Pediatric Pain Tool. A total of 41 participants completed all study procedures. Results: No statistically significant difference in burn wound care procedural pain was noted between the VR and SC groups after adjusting for several factors. Pre‐procedure state and trait anxiety correlated with reported pre‐procedure pain. Wound care pain was found to be significantly associated with pre‐wound care pain score, time from original burn to clinic burn care treatment, and length of wound care treatment. These factors accounted for approximately 45% of the variation in pain scores during wound care treatment. Practice Implications: VR distraction can be a useful pain management strategy but may not take the place of the unique nurse‐patient relationship that occurs during clinical encounters. Tailoring pain management during burn wound care requires consideration of anxiety, time from the burn injury to the wound care procedure, length of time of the wound care procedure, and pretreatment pain level. Knowing patients' needs, desires, and temperaments along with the specifics about the healthcare procedures are critical to formulating individualized care plans that may or may not include VR. Newer technology, such as easier‐to‐use, less expensive VR, may assist with translation into practice making its clinical use more routine. [ABSTRACT FROM AUTHOR]

This study sought to evaluate the impact of the subcutaneous tunneling technique on peripherally inserted central catheter (PICC) placement. We randomized 694 patients who needed PICC placement to either the tunneled PICCs (experimental group) or the non-tunneled PICCs (control group) from August to December 2021. The cumulative frequency of complications was assessed as the primary outcome. Secondary outcomes comprised of the amount of bleeding, catheter insertion time, self-reported pain score, and one-puncture success rate. After 6 months of follow-up, the tunneled PICCs group showed a significant decrease in the frequency of total complications, especially in infection (3.0% vs. 7.1%, p =.021) and catheter-related thrombosis (3.3% vs. 8.3%, p =.008), although approximately 0.5 ml bleeding and 3.5 min time were increased. This randomized multicenter study supports the efficacy of subcutaneous tunneling technology in reducing PICC-related complications, enhancing patient comfort, and encouraging using subcutaneous tunneling technology for PICC placement. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to develop a mobile application for improving self‐management and to evaluate its effects in adult patients on peritoneal dialysis (PD). Methods: This randomized controlled trial was registered with the Korean Clinical Research Information Service Registry (KCT0007267) and conducted at a tertiary hospital. A self‐management mobile application (SMA) was developed based on social cognitive theory and the ADDIE (analysis, design, development, implementation, and evaluation) model. The SMA includes information about disease management; self‐recording of data on diet, exercise, medication, and health behavior; and healthcare providers' support and feedback. Participants aged 19–65 years were randomly allocated to the intervention group (n = 27) using the SMA for 10 weeks, and the control group (n = 26) receiving usual care. PD‐related knowledge and self‐efficacy, PD‐related health behavior, biomarkers, and health‐related quality of life (HRQoL) were surveyed pretest/posttest and analyzed using SPSS 23.0. Results: Compared to the controls, the intervention group showed significant improvement in PD‐related knowledge and health behavior, albumin, and hemoglobin. HRQoL domains of symptoms/problems of kidney disease and disease impact on daily activity were improved in the intervention group. Conclusion: The SMA is an effective intervention for enhancing health behaviors as well as improving the HRQoL of patients with PD. Without any limitations on time or location, patients with PD can easily use the SMA to monitor their health conditions, efficiently manage their disease, and perform PD‐related behaviors. Nurses can implement high‐quality tailored healthcare by using patients' lifelog data from the SMA. [ABSTRACT FROM AUTHOR]

Chinese herbal medicine is increasingly used as complementary therapy to manage nausea and vomiting in different cultures. One such herbal recipe is the Hezhong granules, which contain classical antiemetic formulations, and are commonly used to prevent chemotherapy-induced nausea and vomiting (CINV). Modern pharmacological studies have shown that the key components of Hezhong granules, including Pinellia ternata (Thunb.), Evodia rutaecarpa (Juss.), and Zingiber officinale exhibit significant antiemetic and antitumor properties. Despite this promising evidence, controlling CINV remains a significant challenge in cancer treatment. Moreover, there is a lack of scientifically designed clinical trials to validate the efficacy and safety of classical antiemetic formulas for CINV interventions. To investigate the efficacy and safety of Hezhong granules in preventing CINV in patients with advanced colorectal cancer (CRC). This study was conducted between October 2020 and February 2022 in 12 hospital wards in Southwest China. In this multicenter, randomized controlled trial, we enrolled patients with advanced CRC who received fluorouracil-based chemotherapy. The patients were randomly assigned in a 1:1 ratio to either the Hezhong granule group (receiving a 5-HT3-receptor antagonist, dexamethasone, and Hezhong granules) or the placebo group (receiving a 5-HT3-receptor antagonist, dexamethasone, and placebo) during the first and second courses of chemotherapy. A 5-day diary was provided to all patients. Acute and delayed CINV were defined as CINV occurring within 24 h or between 24 and 120 h after the start of treatment. The primary endpoints were complete response rate (CRR, defined as the proportion of patients without nausea/vomiting) and objective response rate (ORR, defined as the proportion of patients without nausea/vomiting plus mild nausea/vomiting) for both acute and delayed CINV. Secondary endpoints were the daily rates of CINV events and Functional Living Index-Emesis (FLIE). To identify the predictors of CINV, we conducted multivariate ordered logistic regression analysis. This study was registered with the Chinese Clinical Trial, number ChiCTR2100041643. A total of 120 participants were randomly assigned, of whom 112 (56/56) completed two cycles and were included in the full analysis. In the acute phase, there were minor improvements in the Hezhong granule group, but there were no significant differences in the CRRs for nausea and vomiting (mean difference:10.7 %, P = 0.318, 0.324), while the ORRs increased by approximately 17.5 % (mean difference:16.1 %, P = 0.051; 17.9 %, P = 0.037, respectively). In the delayed phase, significant improvements of approximately 20 % were observed in both the CRRs (mean difference:19.6 %, P = 0.053; 21.4 %, P = 0.035) and ORRs (mean difference:17.9 %, P = 0.037, 0.043) for nausea and vomiting. Additionally, the daily rate of CINV events showed a mean difference of 19 % (P < 0.05). According to FLIE scores, approximately 70 % of patients who received Hezhong granules reported an improvement in their quality of life, with CINV symptoms having"no impact on daily life (NIDL)". No serious adverse events were attributed to herbal medicine. Hezhong granules proved to be both effective and well-tolerated in preventing CINV in patients with advanced CRC, with notable benefits in preventing delayed CINV. These promising results set the stage for subsequent phase III clinical trials and experimental research on Hezhong Granules. [Display omitted] • Hezhong granule can increase the complete response rate of CINV by about 10 %–20 %. • Hezhong granule can increase the objective response rate of CINV by about 16 %–18 %. • Hezhong granule show better efficacy in preventing delayed CINV. • Hezhong granule is well tolerated and can significantly improve the quality of life of patients. [ABSTRACT FROM AUTHOR]

Although swallowing exercises are a fundamental treatment for dysphagia, few studies have evaluated the effectiveness of swallowing training in patients with Alzheimer's disease. We recruited 93 patients with Alzheimer's disease from three hospitals in Guangdong, China. This was a parallel armed randomized controlled trial that randomly assigned patients to intervention (n = 48) and control (n = 45) groups. The intervention group adopted systematic stepwise swallowing training for four weeks based on routine dysphagia care. The control group implemented routine dysphagia care, including diet and posture management and health education about swallowing dysfunction. The swallowing function was the primary outcome, which was assessed using the Water Swallowing Test and Standard Swallowing Assessment. An abnormal eating behavior questionnaire was used to assess the incidence of aberrant eating behavior in patients with Alzheimer's disease. The Mini-Nutritional Assessment Short Form and Barthel index were adopted to evaluate the nutritional status and ability to carry out daily activities between groups. SPSS software was used to perform the chi-square test, t -test, and generalized estimation equation for data analysis. We analyzed the effects of the stepwise swallowing training program using the generalized estimating equation method. The intervention group exhibited greater improvements in their swallowing function (Water Swallowing Test: β = − 3.133, 95 % CI: − 4.113, − 2.154, P < 0.001; Standard Swallowing Assessment: β = − 5.813, 95 % CI: − 7.782, − 3.844, P < 0.001), abnormal eating behaviors (abnormal eating behavior questionnaire: β = − 13.324, 95 % CI: − 21.643, − 5.005, P = 0.002), daily function (Barthel index: β = 11.280, 95 % CI: 4.021, 18.540, P = 0.002), and nutritional status (Mini-Nutritional Assessment Short Form: β = 2.402, 95 % CI: 1.313, 3.490, P < 0.001) over time than the routine-care group in the fourth week. Stepwise swallowing training is a safe and effective intervention for managing dysphagia and other related symptoms in patients with Alzheimer's disease. [ABSTRACT FROM AUTHOR]