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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: This randomized controlled trial aimed to compare the effects of butorphanol and sufentanil on early post-operative cognitive dysfunction (POCD) and systemic inflammation in older surgical patients. Methods: Patients (aged 65  years or above) undergoing surgeries with general anesthesia were randomized to either the butorphanol group (40  μg/kg during anesthesia induction) or the sufentanil group (0.4  μg/kg). Cognitive function changes during the perioperative period were assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) scale up to 3  days after surgery. POCD was defined as a Z-score or composite Z-score greater than 1.96 for both MMSE and MoCA scores. Circulating inflammatory factors, including tumor necrosis factor-alpha (TNF-α), interleukin 1 beta (IL-1β), and interleukin 10 (IL-10), were measured using enzyme-linked immunosorbent assay. Results: The study included 114 patients (median age: 71  years, 57.7% male). Compared to sufentanil, butorphanol significantly reduced the incidence of POCD on the first (11.5% versus 32.7%, p  =  0.017) and third day (3.8% versus 15.4%, p  =  0.046) after surgery. Additionally, patients receiving butorphanol had significantly lower circulating levels of TNF-α and IL-1β at the time of discharge from the post-anesthesia care unit and on the first and third day after surgery (p  <  0.05 for all comparisons). Furthermore, circulating IL-10 levels were significantly higher in patients receiving butorphanol (p  <  0.05 for all comparisons). Conclusion: Administration of butorphanol during anesthesia induction, as opposed to sufentanil, was associated with a significant reduction in the early incidence of POCD in older surgical patients, possibly attributed to its impact on systemic inflammation. [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]

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]

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 Recurrent Clostridioides difficile infection (rCDI) occurs frequently, and concomitant antibiotic (CA) during the initial episode for treatment of non-CDI is a major risk factor. We sought to address the comparative efficacy of fidaxomicin versus vancomycin in the setting of CA during the initial CDI episode. Methods We conducted a randomized, controlled, open-label trial at 2 hospitals in Ann Arbor, Michigan. We consecutively consented and enrolled hospitalized patients ≥18 years old with diarrhea, a positive test for C. difficile , and ≥1 qualifying CA. Complicated CDI, CDI treatment for >24 hours prior to enrollment, and planned long-term (>12 weeks) CA use were notable exclusions. Clinical cure was defined as resolution of diarrhea for 2 consecutive days maintained until 2 days after therapy, and rCDI as recurrent diarrhea with positive testing ≤30 days after initial treatment. Patients were randomized to fidaxomicin or vancomycin. Results Baseline characteristics were similar in the 2 groups of 144 patients. Rates of clinical cure (73% vs 62.9%, P =.195) and rCDI (3.3% vs 4.0%; P >.99) were similar for fidaxomicin and vancomycin in the intention-to-treat and per-protocol cohorts, respectively. Only 4 patients developed rCDI. Conclusions In this study of patients with CDI receiving CA, a numerically higher proportion were cured with fidaxomicin versus vancomycin, but this result did not reach statistical significance. Overall recurrence was lower than anticipated in both arms compared with previous studies that did not extend duration of CDI treatment during CA. Clinical Trials Registration www.clinicaltrials.gov (NCT02692651). [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]

Background: This study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA). Methods: This study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded. Results: A total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group (P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication. Conclusions: Compared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects. Trial Registration: ISRCTN34355813. Registered on 25/01/2021. [ABSTRACT FROM AUTHOR]

Background: Cardiac rehabilitation (CR) referral and participation are generally found to be underused worldwide. The data in Asian regions suggest significant underutilization compared with western countries. Objectives: To promote the continuity and effects of CR, this study aimed at supporting self-care and improving CR effects in phase II CR with mobile health application for Macao patients who have undergone percutaneous coronary intervention. Methods: The study was a randomized controlled trial conducted between January 2018 and June 2020 in a nongovernmental Hospital. Social cognitive theory was applied in the intervention for an experimental group. Measurements including anxiety and depression level, medication adherence, exercise capacity, physical activity level, cardiovascular risk modification, self-efficacy, quality of life, use of healthcare resources, mHealth CR utility, and satisfaction were analyzed. Results: One hundred forty eligible patients were recruited, and 110 patients completed the study. Significant interventional effects of the experimental group were found on the reduction of total cholesterol, low-density lipoprotein, sitting time, anxiety level, and total anxiety and depression level (P <.05). In addition, significant improvement on the 6-minute walk test, regular exercise performance, self-efficacy of cardiac exercise and diet, and quality of life were found as interventional effects in the experimental group (P <.05). The feasibility of intervention was achieved in a satisfactory level. Conclusions: This theoretically grounded mobile health CR study was a unique program tailor-made to meet the care needs of patients post percutaneous coronary intervention. It was feasible and effective to support CR effects and adherence and would inform further design of clinical practice and public policies. [ABSTRACT FROM AUTHOR]

Background: Postpartum depression (PPD) affects up to one in five mothers and birthing parents, yet as few as 10% access evidence-based treatment. One-day cognitive behavioral therapy (CBT)-based workshops for PPD have the potential to reach large numbers of sufferers and be integrated into stepped models of care. Methods: This randomized controlled trial of 461 mothers and birthing parents in Ontario, Canada with Edinburgh Postnatal Depression Scale (EPDS) scores ⩾10, age ⩾18 years, and an infant <12 months of age compared the effects of a 1-day CBT-based workshop plus treatment as usual (TAU; i.e. care from any provider(s) they wished) to TAU alone at 12-weeks post-intervention on PPD, anxiety, the mother–infant relationship, offspring behavior, health-related quality of life, and cost-effectiveness. Data were collected via REDCap. Results: Workshops led to meaningful reductions in EPDS scores (m = 15.77 to 11.22; b = −4.6, p < 0.01) and were associated with three times higher odds of a clinically significant decrease in PPD [odds ratio (OR) 3.00, 95% confidence interval (CI) 1.93–4.67]. Anxiety also decreased and participants had three times the odds of clinically significant improvement (OR 3.20, 95% CI 2.03–5.04). Participants reported improvements in mother–infant bonding, infant-focused rejection and anger, and effortful control in their toddlers. The workshop plus TAU achieved similar quality-adjusted life-years at lower costs than TAU alone. Conclusions: One-day CBT-based workshops for PPD can lead to improvements in depression, anxiety, and the mother–infant relationship and are cost-saving. This intervention could represent a perinatal-specific option that can treat larger numbers of individuals and be integrated into stepped care approaches at reasonable cost. [ABSTRACT FROM AUTHOR]

Objective: Limited studies have yet evaluated the effectiveness of topiramate in the treatment of amphetamine and methamphetamine addiction. Therefore, the aim of this study was to investigate the effectiveness of topiramate in the treatment of patients with this disorder. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 52 patients with amphetamine and methamphetamine use disorder, within the age range of 16-60 years, were randomly divided into an intervention group (n = 26) and a placebo group (n = 26). The intervention group was treated with topiramate tablets with a starting dose of 50 mg, which was gradually increased to the target dose of 200 mg. The control group was treated with placebo. The duration of drug intervention in this clinical trial was 12 weeks, and all participants were evaluated before the intervention and 2, 4, 6, 8, 10, and 12 weeks after beginning the intervention. The Beck Depression Inventory, drug use temptation questionnaire, urine test, and side effects questionnaire were used as outcome measures to assess the patients. The data were analyzed using chi-square, independent t-test, and analysis of variance with repeated measurements. Results: There was no significant difference between the intervention and placebo groups in depression at the beginning of the treatment and at the 4th, 8th, and 12th weeks after the intervention (P > 0.05). The urine test also showed no significant difference between the two groups at any of the evaluation stages (P > 0.05). Although there was no significant difference between the two groups in the drug use temptation results at the beginning and the 2nd, 4th and 6th weeks (P > 0.05), the level of drug temptation in the intervention group was significantly lower than the placebo group in the 8th, 10th, and 12th weeks (P < 0.05). Conclusion: Topiramate can be effective in reducing the desire to use amphetamine and methamphetamine. However, further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Aims Burns and wounds caused by it are a global injury. Finding natural ingredients to accelerate wound healing in patients with fewer side effects could be valuable. This study aimed to determine the effect of oral Centella asiatica extract on the healing of pain and wound of burn in patients. Materials & Methods This study is a clinical trial in which 76 patients hospitalized in the burn department were randomly divided into two intervention (n=38) and control (n=38) groups. The intervention group, in addition to the usual antibiotic treatments, received capsules containing 200mg of Centella asiatica twice daily, and the control group received capsules containing 200mg of starch twice daily. Data collection tools were Bates-Jensen Wound Assessment tool and Visual Analog Scale. Patients' pain and wound healing status were examined at different time of the study. Findings The mean burn pain score showed a significant improvement in the intervention group compared to the control group (p<0.001). The average wound healing score did not show significant improvement in the intervention group compared to the control group (p=0.561). However, size (p=0.023), the degree of destruction of the underlying tissues (p=0.032), the amount of necrotic tissue (p=0.015), and the amount of granulation tissue (p=0.001) improved significantly in the intervention group. In addition, the peripheral tissue edema in the control group decrease significantly compared to the intervention group (p=0.008). Conclusion Oral extract of Centella asiatica reduces pain in burn patients. However, it does not affect wound healing, although it improves some wound healing indicators. [ABSTRACT FROM AUTHOR]

Objectives: Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this trial against placebos in the treatment of the menopausal syndrome. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty women with menopausal syndrome. Interventions: Group 1 (n = 30; IHMs plus concomitant care; verum) versus group 2 (n = 30; placebos plus concomitant care; control). Outcome measures: Primary—the Greene climacteric scale (GCS) total score and menopause rating scale (MRS) total score, and secondary—the Utian quality of life (UQOL) total score; all of them were measured at baseline and every month up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 two-tailed. Between-group differences were nonsignificant statistically—GCS total score (F1, 58 = 1.372, p = 0.246), MRS total score (F1, 58 = 0.720, p = 0.4), and UQOL total scores (F1, 58 = 2.903, p = 0.094). Some of the subscales preferred IHMs significantly against placebos—for example, MRS somatic subscale (F1, 56 = 0.466, p < 0.001), UQOL occupational subscale (F1, 58 = 4.865, p = 0.031), and UQOL health subscale (F1, 58 = 4.971, p = 0.030). Sulfur and Sepia succus were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group. Conclusions: Although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis. Clinical trial registration number: CTRI/2019/10/021634 [ABSTRACT FROM AUTHOR]

Unsuccessful treatment of pulmonary tuberculosis results from medication non-adherence. Family is a significant source of support for adults with pulmonary tuberculosis but has limited ability to continuously support in the first six months of treatments. This randomized controlled trial, a two-arm post-test-only design was utilized to investigate the effects of the family empowerment program on medication adherence and treatment success among adults with pulmonary tuberculosis. The sample comprised 64 family members caring for newly diagnosed adults with pulmonary tuberculosis who visited a tuberculosis clinic of a university hospital in central Thailand. The participants were assigned randomly to either the experimental arm (n = 32) to receive the program or the control arm (n = 32) to receive only usual care. Data were collected using the Demographic and Pulmonary Tuberculosis-related Characteristic Data Collection Form, Family Member's Demographic Characteristic Data Collection Form, Tuberculosis Medication Adherence Scale, and criteria to identify tuberculosis treatment success of the World Health Organization. Data were analyzed using descriptive statistics, Pearson's chi-square, Fisher's Exact, and McNemar tests. The results showed that the experimental arm had significantly higher medication adherence at the 3rd and 19th weeks after the program ended than the control arm. The experimental arm had a significantly higher treatment success rate at the 19th week than the control arm. The family empowerment program was effective in improving medication adherence and treatment success. Nurses need to be trained to empower family members in providing continuous support for adults with pulmonary tuberculosis. To fully assess the program's effectiveness, additional research is required to investigate its performance in different contexts and with various samples. [ABSTRACT FROM AUTHOR]

Background: Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer (CRC). However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine practice. Aim: The aim of this study was to examine the efficacy and safety of electroacupuncture (EA) for the alleviation of CIPN in CRC patients. Design: This was a pilot single-blinded, randomized, sham-controlled trial. Setting/participants: Sixty eligible patients, who had been diagnosed with CRC and were undergoing oxaliplatin-based chemotherapy, were randomized in a ratio of 1:1 to the EA intervention group or sham acupuncture (SA) control group. During a 12-week treatment period, patients in the EA group received EA once a week, while patients in the SA group received SA; both groups were followed up for 12 weeks. Results: Compared with the SA group, the EA group exhibited significant alleviation of CIPN severity during chemotherapy. Moreover, EA also improved the physical function, role function, and social function of CRC patients. However, there were no significant differences in tests of vibration or light touch sensation. In addition, EA appeared to be a safe treatment for CIPN and was both feasible and acceptable to CRC patients during chemotherapy. Conclusion: This study showed preliminary evidence for the efficacy and safety of EA in acute CIPN among CRC patients, although further studies are needed to verify these effects and to further explore the potential role of EA in chronic CIPN (effects on which remain unclear). Trial registration number: NCT03582423 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Background: This study aimed to assess the feasibility and acceptability of an oral health self-care e-learning intervention for overseas workers as well as the research procedures for a future controlled trial. Methods: We randomly allocated participants to either the intervention (n = 48) or control (n = 51) group. The intervention group received a standardized leaflet plus a theory-based oral health e-learning program. The control group received only the standardized leaflet. We assessed health behaviour related to fluoride toothpaste use, oral care knowledge, motivation, oral care self-efficacy, and oral health related quality of life (QoL). Chi-square and t test analyses were performed to make comparisons between the two groups. To evaluate the research process, participants in the intervention group were asked open-ended questions to assess the acceptability and feasibility of the research procedures in practice. Results: A total of 82 participants (Intervention = 36, Control = 46) were included in the analysis. The dropout rate was 17.2%. The modal time taken to complete the e-learning intervention was more than 30 min (33.3%). Of the 36 respondents in the intervention group, 27 (70.4%) said that the e-learning intervention had changed their behaviour. At the three months follow-up, oral care knowledge alone was improved in the e-learning group. Conclusion: This pilot study provides evidence that the theory-based self-care for oral health e-learning intervention is feasible in overseas workers. Next, this feasible and acceptable pilot study should be used with an appropriate sample size in a randomized controlled trial. Trial registration: The trial protocol was registered with UMIN-CTR (ID: UMIN000045883) on 27/10/2021. [ABSTRACT FROM AUTHOR]

To determine the efficacy of the "Training for Occupational health physicians To Involve Significant others" (TOTIS) e-learning module for improving occupational health physicians' (OHPs) knowledge, attitudes, and self-efficacy regarding involving significant others in the return-to-work process. A randomized controlled trial with 87 OHPs, involving an intervention group and a wait-listed control group. Between-group differences in knowledge, attitude, and self-efficacy outcomes, and retention of effects were assessed using ANOVA and paired t-tests. Reactions to the e-learning module were analyzed with descriptive statistics and thematic analysis. We found moderate to large effects on OHPs' knowledge (p < 0.001, ηp2 = 0.202), attitudes (p = 0.003, ηp2 = 0.098), and self-efficacy (p < 0.001, ηp2 = 0.237), with retention of all changes at 10-week follow-up. OHPs graded the e-learning module with a mean score of 7.9 out of 10 (SD = 1.11) and indicated that the module increased their awareness of the role of significant others and encouraged them to address this more often. The TOTIS e-learning module and accompanying materials are valuable resources for OHPs to learn how significant others influence work outcomes of workers with chronic diseases and to manage their involvement in the re-integration process. This study is registered in the Netherlands Trial Register under trial number NL8744; . The TOTIS e-learning module is the first evidence-based training to improve the knowledge, attitudes, and self-efficacy of occupational health physicians with regard to involving significant others in the re-integration process of workers with chronic diseases. The e-learning module and accompanying tools can increase the awareness of occupational health physicians about the role of significant others and encourage them to address the role of significant others in the re-integration process of sick-listed workers. It could be beneficial to expand on the e-learning module with a face-to-face training program involving group interaction, peer discussion, and skills development. [ABSTRACT FROM AUTHOR]

Background: The risk of postoperative cognitive dysfunction(POCD) in laparoscopic surgery should not be overlooked. Intravenous lidocaine can reduce perioperative inflammatory response in patients undergoing laparoscopic surgery, while the effect of intraoperative intravenous lidocaine on postoperative cognitive function in patients undergoing laparoscopic colorectal cancer surgery has not been well studied. We investigated whether intraoperative lidocaine improves postoperative cognitive function after laparoscopic radical resection for colorectal cancer. Methods: We conducted a prospective, randomized double blinded controlled trial to investigate the effect of intravenous lidocaine on rapid postoperative recovery in patients undergoing laparoscopic radical resection of colorectal cancer. The patients were randomly assigned to receive either intravenous lidocaine or saline. The primary outcome was cognitive dysfunction defined by a decrease from pre- to postoperative ≥ 2 of the Mini-Mental State Examination (MMSE) score, at the 3rd and the 7th postoperative days. Secondary outcomes were the MMSE raw score and parameters of the patients' postoperative recovery such as agitation and length of stay in the post-anaesthesia care unit (PACU), length of hospital stay, markers of inflammation (white blood cell count and CRP), and incidence of complications. Results: Seventy-three patients in the lidocaine group and 77 patients in the control group completed the trial. The rate of cognitive dysfunction was lower in the lidocaine group than that in the control group, both at the 3rd (18.57% vs. 63.64% for each group respectively; RR = 0.26, 95%CI = 0.19–0.32; p < 0.0001) and at the 7th postoperative day (12.33% vs. 53.25% for each group respectively; RR = 0.28, 95%CI = 0.22–0.35; P < 0.001). The postoperative MMSE scores were also higher in the lidocaine group than in the control group both at the 3rd (median 25 vs. 24 respectively) and at the 7th postoperative day (26 vs. 24 respectively). Also, patients in the lidocaine group displayed a lower white blood cell count than the control group at the 1st postoperative day (8.5 ± 2.7 vs. 10.4 ± 3.3; p < 0. 001). No differences were evidenced for the other secondary outcomes. Conclusions: Intraoperative intravenous lidocaine can significantly improve postoperative cognitive function in patients undergoing laparoscopic radical resection of colorectal cancer. Trial registration: Chinese Clinical Trial Registry (16/1/2022, registration number: ChiCTR2200055683) [ABSTRACT FROM AUTHOR]

Aims: People living with HIV are at a high risk for cardiovascular disease owing to antiretroviral therapy use and chronic inflammation. There is limited evidence on the evaluation of serum lipid levels through lifestyle modification. This study aims to evaluate the effect of a smartphone application‐based diet and exercise improvement program on men living with HIV and dyslipidemia. Methods: This was a randomized controlled trial recruiting Japanese men living with HIV who have dyslipidemia: intervention group (n = 19) and control group (n = 19). The intervention group received a third individual guidance session during the 6‐month intervention and was encouraged to record their diet on a smartphone application. An intention‐to‐treat analysis of the results was conducted. Results: The intervention group showed significantly reduced change in low‐density lipoprotein levels compared to the control group (−4.00 ± 20.2 mg/dL vs. 10.11 ± 21.1 mg/dL) (p =.042) from baseline to 6 months post‐intervention. No significant differences were found in other serum lipid levels. Abdominal circumference decreased significantly in the intervention group (p =.048) from baseline to 6 months post‐intervention. Total energy, protein, carbohydrate, fat, and salt intake, dietary and physical activity behavior change stages and social support, dietary self‐efficacy, and loneliness significantly improved in the intervention group (p <.05) from baseline to 6 months post‐intervention. Conclusions: A diet and physical activity improvement program using a smartphone application based on Japanese‐specific health guidance may reduce low‐density lipoprotein cholesterol levels in this population. Further sample expansion and examination of long‐term effects are needed. [ABSTRACT FROM AUTHOR]

Background: Many individuals with posttraumatic stress disorder (PTSD) have limited access to first-line treatments, warranting the development of remotely-delivered treatments. Attention bias modification (ABM), targeting perturbed threat-related attentional patterns, shows promise when delivered in-person. However, previous studies found ABM to be ineffective when delivered remotely. Randomized clinical trials usually applied two variations of ABM: ABM away from threat or attention control training (ACT) balancing attention between threat-related and neutral stimuli. We tested remotely-delivered ACT/ABM with tighter supervision and video-based interactions that resemble in-clinic protocols. We expected to replicate the results of in-clinic trials, in which ACT outperformed ABM for PTSD. Methods: In this double-blinded, parallel-group randomized controlled trial, 60 patients diagnosed with PTSD were randomized (ABM n = 30; ACT n = 30). Patients performed eight bi-weekly remotely-delivered supervised ABM/ACT sessions. Symptoms were assessed pre- and post-treatment with Clinician-Administered PTSD Scale 5 (CAPS-5) severity score and PTSD diagnosis as the primary outcomes. Current depressive episode, current anxiety-related comorbidity, and time elapsed since the trauma were examined as potential moderators of treatment outcome. Results: Significant decrease in CAPS-5 severity scores and PTSD diagnosis was observed following both ACT and ABM with no between-group difference. Patients without depression or whose trauma occurred more recently had greater symptom reduction in the ACT than the ABM group. Conclusions: Contrary to our expectation, symptoms decreased similarly following ACT and ABM. Moderator analyses suggest advantage for ACT in non-depressed patients and patients whose trauma occurred more recently. Further refinements in remotely-delivered ABM/ACT may be needed. [ABSTRACT FROM AUTHOR]

Background Few studies have focused on the immune response to more recent influenza vaccine formulations such as cell-cultured inactivated influenza vaccine (ccIIV4) or live-attenuated influenza vaccine (LAIV4) in older children and young adults, or differences in immunoglobulin response using newer antibody landscape technology. Methods Participants ages 4–21 were randomized to receive ccIIV4 (n = 112) or LAIV4 (n = 118). A novel high-throughput multiplex influenza antibody detection assay was used to provide detailed IgG, IgA, and IgM antibody isotypes, along with hemagglutination inhibition levels (HAI), measured pre- and 28 days post-vaccination. Results The HAI and immunoglobulin isotype response to ccIIV4 was greater than LAIV4, with significant increases in IgG but not IgA or IgM. The youngest participants had the highest LAIV4 response. Prior LAIV4 vaccination was associated with a higher response to current season ccIIV4. Cross-reactive A/Delaware/55/2019(H1N1)pdm09 antibodies were present pre-vaccination and increased in response to ccIIV4, but not LAIV4. Immunoglobulin assays strongly correlated with and confirmed the findings of HAI titers to measure immune response. Conclusions Age and prior season vaccination may play a role in the immune response in children and young adults to ccIIV4 and LAIV4. While immunoglobulin isotypes provide high-level antigen-specific information, HAI titers alone can provide a meaningful representation of day 28 post-vaccination response. Clinical Trials No NCT03982069 [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effects of mutual goal‐based continuous care program on the outcomes of patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI). Design: A single‐blinded randomized controlled trial. Methods: 87 patients with CHD after PCI in Hangzhou, Zhejiang, China, were randomly divided into study (n = 42) and control (n = 45) groups. The control group received 12‐week cardiac rehabilitation and routine care. The study group received routine care and cardiac rehabilitation and the 12‐week intervention program developed according to the goal attainment theory, including the mutual goal‐based face‐to‐face guidance, and every‐2‐week telephone follow‐ups. The self‐management behaviour, quality of life, unscheduled readmission rate, and satisfaction of patients were examined. Results: For the patients subjected to the developed continuous nursing program based on mutual goals, achievement rates of all dimension mutual goals were at high levels (from 80.21% to 98.41%), except for the weight control (60.94%). Moreover, according to the comparable base data, compared with the control group, the self‐management behaviour (study group 93.43 vs. control group 76.00), quality of life (QoL), and patients' satisfaction (study group 4.64 vs. control group 4.11) were higher, while the unscheduled readmission rate (study group 4.76% vs. control group 22.22%) was lower, in the study group, with statistically significant differences. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Background: People aging with long-term physical disabilities are living longer and experiencing the challenges of aging, including the onset of secondary and age-related health conditions. People aging with long-term physical disabilities are at high risk of falls, fall injuries, diminished functional abilities, and compromised participation. However, no available programs support people aging with long-term physical disabilities to participate safely at home and in the community. The proposed study is to examine the feasibility and efficacy of an adapted intervention: removing environmental barriers to independent living. Method/Design: A single-blinded randomized controlled trial will be conducted. Participants who are 45–65 years old; self-report difficulty with ⩾2 daily activities; have had a physical disability for ⩾5 years; and live within 60 mi of the research lab are eligible. All participants will receive an initial in-home evaluation before randomization. The treatment group will receive removing environmental barriers to independent living (total five visits) intervention, which is tailored. The waitlist control group will be offered the same intervention after 6-month follow-up. Expected outcomes are high acceptability, fidelity, and adherence; low safety risk; improved community participation and daily activities performance; and fewer environmental barriers and fall hazards. Discussion: Findings will serve as preliminary evidence for occupational therapy community practice. Outcomes will also inform future large, pragmatic trials. Trial Registration: ClinicalTrials.gov identifier NCT04589988 [ABSTRACT FROM AUTHOR]

Simple Summary: Effective and scalable diet, exercise, and weight management interventions are needed for primary cancer prevention in the general public, as well as for cancer control and tertiary prevention among the growing population of cancer survivors. A 6-month online intervention, entitled "Daughters, dUdes, mothErs, and others Together" (DUET), was designed to promote weight loss, a healthful diet, and increased physical activity among cancer survivors and their chosen partners. Fifty-six cancer survivor-partner dyads (n = 112 participants in total) were recruited into a randomized controlled trial that compared DUET to a waitlist control. The trial surpassed all feasibility endpoints with regard to uptake, retention, and safety; the DUET intervention also resulted in significant weight loss and reductions in caloric intake, as well as having a promising impact on physical activity and performance, blood glucose, and indicators of inflammation. (1) Background: A healthful diet, regular physical activity, and weight management are cornerstones for cancer prevention and control. Yet, adherence is low in cancer survivors and others, calling for innovative solutions. Daughters, dUdes, mothers, and othErs fighting cancer Together (DUET) is a 6-month, online, diet-and-exercise, weight-loss intervention to improve health behaviors and outcomes among cancer survivor-partner dyads. (2) Methods: DUET was tested in 56 dyads (survivors of obesity-related cancers and chosen partners) (n = 112), both with overweight/obesity, sedentary behavior, and suboptimal diets. After baseline assessment, dyads were randomized to DUET intervention or waitlist control arms; data were collected at 3- and 6-months and analyzed using chi-square, t-tests, and mixed linear models (α < 0.05). (3) Results: Retention was 89% and 100% in waitlisted and intervention arms, respectively. Dyad weight loss (primary outcome) averaged −1.1 (waitlist) vs. −2.8 kg (intervention) (p = 0.044/time-by-arm interaction p = 0.033). Caloric intake decreased significantly in DUET survivors versus controls (p = 0.027). Evidence of benefit was observed for physical activity and function, blood glucose, and c-reactive protein. Dyadic terms were significant across outcomes, suggesting that the partner-based approach contributed to intervention-associated improvements. (4) Conclusions: DUET represents a pioneering effort in scalable, multi-behavior weight management interventions to promote cancer prevention and control, calling for studies that are larger in size, scope, and duration. [ABSTRACT FROM AUTHOR]

Diabetic retinopathy is a microvascular complication of diabetes resulting in visual impairment. Controlling the progression of diabetic retinopathy and living with visual impairment are crucial tasks and skills for older people with diabetic retinopathy and visual impairment. This randomized controlled trial investigated the effects of a self- and family management support program on health outcomes of Thai older people with diabetic retinopathy and visual impairment who lived with family members in the community and on family satisfaction. Eighty-four participants were recruited at an eye-specialized hospital in a central province of Thailand and randomly assigned to either the experimental group (n = 42) or the comparison group (n = 42). The experimental group received the intervention program plus usual care, while the comparison group received only usual care. Instruments for data collection included a Demographic Data Form, the Perceived Security in Performance of Daily Life Activities Questionnaire, the Self-Management Behavior Questionnaire, the Sirindhorn National Medical Rehabilitation Center Functional Assessment, the Thai Visual Function Questionnaire 28, and the Family Satisfaction Questionnaire. Data analyses were performed using descriptive statistics, t-test, chi-square, two-way repeated measures ANOVA, and ANCOVA. Results showed that the experimental group had significantly more improved perceived security, self-management behavior, HbA1c, visual-related quality of life: performing activities dimension, and family satisfaction than the comparison group at Week 16. However, no significant differences in perceived security, self-management behavior, functional ability, and overall visual-related quality of life were found between the two groups at Week 8. This program be further tested before being implemented into practice. However, it has a potential for healthcare providers to create an intervention program encompassing disease control and skill training for older people with diabetic retinopathy and visual impairment and encourage their families to support them. [ABSTRACT FROM AUTHOR]

It is believed that clinical management of osteoarthritis should address muscle weakness to improve physical function and prevent disability and frailty This sub-study investigated the effects of supervised progressive resistance training (RT), supervised Nordic Walking (NW), and unsupervised home-based exercise (HBE) on muscle and functional performance; and associations between these exercise-induced changes in persons with hip osteoarthritis. Forty-two patients with hip osteoarthritis were recruited from a larger RCT (NCT01387867). All the groups (RT, n = 15; NW, n = 12; HBE, n = 15) exercised 1 h 3 times/week for 4 months. Quadriceps cross-sectional area (QCSA, MRI-determined); quadriceps strength (QMVC); leg extensor power (LEP); functional performance (chair stands (30sCS); stair climbs (TSC); and 6-minute walk (6MWT)) were assessed at baseline and 4 months. Per protocol analyses (one-way ANOVA and Bonferroni test) showed significant between-group differences for improvements in QCSA in the most symptomatic leg favoring RT versus NW (2.3 cm2, 95% CI [0.6, 3.9]) and HBE (2.3 cm2 [0.8, 3.9]); and 30sCS (1.8 repetitions [0.2–3.3]), and 6MWT (35.1 m [3.5–66.7]) favoring NW versus HBE. Associations existed between exercise-induced changes in QCSA and QMVC (r = 0.366, p =.019) for the most symptomatic leg and between changes in 6MWT and QMVC (r = 0.320, p =.04) and LEP (r = 0.381, p =.01), respectively, for the least symptomatic leg. Resistance training appeared effective for improving muscle mass, but less effective for improving muscle strength, power, and functional performance. Only exercise-induced changes in muscle strength and power of the least symptomatic leg, not the most symptomatic leg, were related to changes in functional performance. [ABSTRACT FROM AUTHOR]

Objective: Sleep disturbance is one of the most prevalent problems in post-menopausal females. The current research intended to evaluate the effects of Dracocephalum on sleep disorder in post-menopausal females. Method: The current study is a randomized, double-blind controlled trial, in which 110 post-menopausal women were randomly allocated to Dracocephalum or placebo groups. The intervention group took Dracocephalum capsules containing 250 mg Dracocephalum extract twice daily for one month. While, the placebo group took the same capsule containing 250 mg of starch twice daily for one month. Pittsburgh Sleep Quality Index was completed by the participants of both groups before and after the treatment and the data obtained were analyzed with Chi-square, paired and independent t-test in SPSS (version 20). Results: The mean score of sleep quality before and after the treatment was 12.69 ± 3.98 and 8.58 ± 1.97 in the treatment group, respectively. Also, the score of sleep quality in the placebo group was 13.48 ± 2.60 and 11.21 ± 2.74 at the beginning and end of the research, respectively. The symptoms of sleep disorder in the intervention group significantly improved after the treatment (P < 0.001), while this was not the case with the placebo group (P = 0.155). Besides, there was a significant difference between the two groups in the mean score of sleep quality after the treatment (P = 0.012). Conclusion: Dracocephalum extracts are effective in reducing symptoms of sleep disorders in post-menopausal women. [ABSTRACT FROM AUTHOR]

Purpose: We examined the effectiveness of the "positive diary," in which family caregivers of people with dementia write down three good things that happened with reasons at the end of each day. Design and Methods: In this randomized controlled trial, the intervention group used the "positive diary," while the control group kept a record of each meal for 4 weeks. Findings: The intervention group showed improvement on several measures of wellbeing including Neuropsychiatric Inventory Questionnaire and Center for Epidemiologic Studies Depression Scale. Practice Implications: The "positive diary" is a useful self‐care tool for caregivers of people with dementia. [ABSTRACT FROM AUTHOR]

This study was carried out to identify the influence of a shock-absorbing insole, developed by the author for use with high-heeled shoes, on walking. The research design included single-blind randomized parallel groups; namely, a group of 26 participants who wore the shock-absorbing insoles and another group of 26 participants who did not wear the insoles, both carried out walking while wearing 7 cm high-heels. During walking, plantar pressure analysis (via in-shoe plantar pressure measurements), surface electrode electromyography (surface EMG), gait analysis, subjective comfort evaluation, and functional movement (functional mobility) analysis were carried out. In order to compare the two groups, statistical verification (paired t-test) was performed. Wearing the shock-absorbing insole with the high-heeled shoes improved posture stability during walking, as well as increasing the walking speed. In addition, the heel pressure, the pressure of the front foot at the inner side, and the shock ability were decreased. For these reasons, the wearers reported higher comfort. Changes in the muscle activities of the tibialis anterior muscle (TA) and the gastrocnemius muscle (GA) heightened the stability of the ankle joints. Overall, the proposed shock-absorbing insole for use with high-heeled shoes improved the postural stability when walking, as well as improving the distribution of pressure on the soles. A decrease in the diverse side-effects of wearing high-heeled shoes can thus be expected. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to examine the effectiveness of an augmented home visiting programme in preventing intimate partner violence among Latinx mothers by nativity. Background: Intimate partner violence diminishes home visit programmes' effectiveness. Immigrant Latinx mothers are especially vulnerable and need culturally tailored prevention. Methods: We performed secondary analyses of 33 US‐born and 86 foreign‐born Latinx mothers at baseline and 1‐ and 2‐year follow‐up in a longitudinal randomized controlled trial of the Nurse‐Family Partnership programme augmented with nurse‐delivered Within My Reach relationship education curriculum and violence screening and referrals in Oregon. We estimated proportional odds models via generalized estimating equations on total physical and sexual victimization and/or perpetration forms (an ordinal variable), adjusting for intervention, wave, age and education. Results: The intervention–nativity interaction was not significant (p =.953). Foreign‐born status was associated with lower reported violence at baseline (adjusted odds ratio: 0.29, 95% confidence interval: 0.13–0.67, p =.004). This association was marginally significant at 1‐year follow‐up (0.43, 0.17–1.08, p =.072) and not significant at 2‐year follow‐up (0.75, 0.33–1.67, p =.475). Conclusions: This augmented programme was not effective for Latinx mothers by nativity. Their nativity gap diminished over time. Implications for Nursing Management: Nursing leaders should support culturally tailored home visiting programmes to detect and prevent intimate partner violence affecting Latinx immigrants. Clinical Trial Registration: This study is registered at www.clinicaltrials.gov NCT01811719. The full trial protocol can be accessed at https://clinicaltrials.gov/ct2/show/NCT01811719. [ABSTRACT FROM AUTHOR]

Aims Tai Chi is a promising exercise option in cardiac rehabilitation to manage coronary heart disease (CHD). Increasing attention was paid on home-based cardiac rehabilitation to improve participation rate, but no study has yet emphasized the effect of home-based Tai Chi. A single-blinded randomized controlled trial is used to examine the effects of a group- plus home-based Tai Chi program on functional health. Methods and results Ninety-eight community-dwelling patients with CHD were randomly assigned to the Tai Chi and control groups. Participants in the Tai Chi group attended 6-week group- plus 6-week home-based Tai Chi program. Outcome measures included physical functions, cardiovascular risk factors, and exercise self-efficacy. Data were collected at baseline, 6-week, 12-week, and 24-week. Intervention effects were analysed using the generalized estimating equation model. Compared with changes in the control group, the intervention group achieved significant improvements in aerobic endurance, lower-body strength, agility and dynamic balance, diastolic blood pressure, and exercise self-efficacy over the 24-week study period (all Ps < 0.05). Intervention adherence was high (79.6% of participants attending >75% of all Tai Chi sessions). Conclusions This Tai Chi program significantly improved the functional health of patients with CHD, indicating that Tai Chi could be taught in group sessions and then continued independently as a home exercise routine for health promotion. [ABSTRACT FROM AUTHOR]

Although aquatic‐based interventions are increasingly used in the psychiatric rehabilitation services, the effects of this type of community program as an adjuvant therapy for psychosocial problems of people with serious mental illness (SMI) have been under‐explored. This research evaluated the feasibility and outcomes of an occupational therapy program consisting of aquatic‐based activities (AA‐OT program) in the community in Spain. This study is the first randomized controlled trial (RCT) on this topic. This pilot trial was conducted with a sample of 16 adults with SMI who were randomly allocated to the AA‐OT program plus treatment as usual or treatment as usual alone (eight in each group). The AA‐OT program included activation of daily living skills, warm‐up, group activities/tasks, and relaxation. It consisted of two sessions per week over 12 weeks. Outcomes were evaluated at week 0 and 12. A total of 14 participants (87.5%) completed the trial. No adverse events or side‐effects were noted. Comparisons between the two groups on change scores showed that participants in the intervention group showed significant improvements in several outcome measures: psychosocial problems (HoNOS), two health‐related quality of life scales (SF‐36: Physical Functioning and Mental Health), and performance of social activities (Activity and Social Relations scale). Satisfaction with the program was high. In conclusion, the results support the feasibility and potential benefits of this occupational therapy program. 12 weeks of aquatic‐based activities in a group intervention may enhance the outcomes of psychiatric rehabilitation improving the severity of psychosocial problems, patient‐reported health status, and social relations. This community‐based program may be beneficial as a non‐pharmacologic method in the illness management and recovery of people with SMI. The findings from this pilot trial need to be confirmed in a large, fully‐powered RCT. [ABSTRACT FROM AUTHOR]

A 3-arm, parallel group, randomized clinical trial examines the effect of aromatherapy through inhalation and foot massage on blood pressure and stress response in patients with essential hypertension. Lavender oil reduced blood pressure, heart rate, serum cortisol, and subjective anxiety in hypertensive patients. [ABSTRACT FROM AUTHOR]

Objective: To study the long-term effectiveness of case-management rehabilitation intervention on vocational reintegration of patients after myocardial infarction (MI). Design: Blinded simple randomization was used to construct an intervention and control groups that were followed up for two years. Subjects and setting: 151 patients, aged 50.3 ± 5.9 years, who experienced uncomplicated MI and were enrolled in a cardiac rehabilitation program were recruited. Interventions: included an early referral to an occupational physician, tailoring an occupational rehabilitation program, based on individual patient needs, coordination with relevant parties, psychosocial intervention, intensive follow-up sessions during a two-year follow-up. Main measures: Return to work within six months of hospitalization and maintenance of employment at one and two years of follow-up. Results: Return-to-work (RTW) rate in the intervention group was 89% and nearly all maintained employment at one year of follow-up (92%) and two years of follow-up (87%). Moreover, almost all of them returned to and maintained their previous jobs. The corresponding figures were: 98%, 94% and 98%, respectively. The figures for the RTW and employment maintenance for the control group were: 74%, 75%, and 72%, respectively. Only about 75%, in this group kept their previous job. The case-management intervention was associated with increased odds of maintaining employment at follow-up of one year (OR = 5.89, 95% CI 1.42–24.30) and two years (OR = 3.12, 95% CI 1.01–10.03). Conclusions: The extended case-management rehabilitation intervention had a substantial positive impact on both the RTW of MI patients and their maintenance of employment at one and two years of follow-up. Trial Registration: This trial is registered at US National Institutes of Health #NCT04934735. [ABSTRACT FROM AUTHOR]

Objective: To determine the clinical effectiveness of adding virtual reality via the Nintendo Wii console and its Wii Balance Board to physiotherapy treatment in patients with total hip arthroplasty. Design: Randomized controlled trial. Setting: Clinical Hospital San Borja Arriaran, Santiago, Chile. Participants: A total of 73 patients over 50 years of age with total hip arthroplasty were randomly allocated to two groups. Interventions: The control group (n = 37) received 6 weeks of physiotherapy treatment; the intervention group (n = 36) received the same treatment plus virtual reality exercises with the Nintendo Wii console. Outcome measures: The two groups were assessed at baseline and after the 6 weeks of treatment. The primary outcome assessed was the function with the WOMAC questionnaire. The secondary outcomes were the Berg Balance Scale, distance covered with the six-minute walk test, and difference in weight load on the lower extremities. Results: A total of 73 patients, 37 patients in the control group (20 women; mean age of 70.9 ± 9.16 years) and 36 patients in the intervention group (18 women; mean age of 70.39 ± 9.02 years) were analyzed. At the end of the treatment, the difference between groups for the total WOMAC score was −10.4 points (p = 0.00), 4.7 points (p = 0.00) for the Berg Balance Scale, and 45.2 mt (p = 0.00) for the six-minute walk test All differences were in favor of the intervention group. Conclusions: In the short term, the addition of virtual reality via the Nintendo Wii and its Wii Balance Board platform showed statistically significant differences in the function of patients with total hip replacement, but these differences were not minimally clinically important. Trial registration : This research was registered in the Clinical Trials Registry of Australia and New Zealand, with reference ACTRN12618001252202. [ABSTRACT FROM AUTHOR]

Background: Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of nonexpanded adipose-derived mesenchymal stem cells. Autologous microfragmented lipoaspirate tissue is expected to create a suitable microenvironment for tendon repair and regeneration. Rotator cuff tears show a high incidence of rerupture and represent an ideal target for nonexpanded mesenchymal stem cells. Purpose: To evaluate the safety and efficacy of autologous lipoaspirate tissue in arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Consecutive patients referring to the investigation center for surgical treatment of magnetic resonance imaging–confirmed degenerative posterosuperior rotator cuff tears were assessed for eligibility. Those who were included were randomized to receive a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology (treatment group) or not (control group). Clinical follow-up was conducted at 3, 6, 12, 18, and 24 months; at 18 months after surgery, magnetic resonance imaging of the operated shoulder was obtained to assess tendon integrity and rerupture rate. Results: An overall 177 patients were screened, and 44 (22 per group) completed the 24-month follow-up. A statistically significant difference in favor of the treatment group in terms of Constant-Murley score emerged at the primary endpoint at 6-month follow-up (mean ± SD; control group, 76.66 ± 10.77 points; treatment group, 82.78 ± 7.00 points; P =.0050). No significant differences in clinical outcome measures were encountered at any of the other follow-up points. No significant differences emerged between the groups in terms of rerupture rate, complication rate, and number of adverse events. Conclusion: This prospective randomized controlled trial demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair. Registration: NCT02783352 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Background: There is insufficient study using Kinesio taping (KT) in bladder problems. Objectives: To investigate the effects of pelvic floor muscle training (PFMT) combined with KT on bladder symptoms, pelvic floor muscle strength, and quality of life in women with overactive bladder (OAB) syndrome and compare this combination with PFMT plus sham tape (ST). Methods: Women with OAB were randomly allocated into PFMT+KT and PFMT+ST groups. All patients were given PFMT for 6 weeks and applied taping according to groups. Before and after treatment, the OAB symptoms with the Overactive Bladder Assessment Form (OAB-V8) and Patients' Perception of Intensity of Urgency Scale (PPIUS), bladder function with a 3-day voiding diary, pelvic floor muscle strength with the Modified Oxford Scale, and quality of life with the King's Health Questionnaire (KHQ) were assessed. Results: OAB-V8, PPIUS, and KHQ scores decreased and the MOS improved in both groups (P <.05) after treatment. The intergroup comparisons revealed a further decrease in voids/day, voids/night, incontinence episodes/day, and personal limitation scores of the KHQ in the PFMT+KT group compared to the PFMT+ST group (P <.05). Conclusion: PFMT+KT was more effective in reducing the OAB symptoms compared to PFMT+ST. KT could be a complementary application for reducing symptoms in OAB. [ABSTRACT FROM AUTHOR]

People with diabetes frequently have elevated diabetes distress. Although mindfulness‐based stress reduction (MBSR) therapy has been shown effective in reducing diabetes distress, it has only been delivered by psychologists or a multidisciplinary team with an attrition rate of up to 39%, which limits its dissemination to a broader audience. This study was aimed to pilot evaluate the feasibility of a nurse‐led MBSR therapy and explore its potential efficacy amongst people with type 2 diabetes mellitus. A total of 100 participants were randomly allocated either to the intervention group (nurse‐led MBSR therapy + regular diabetes education) or the control group (regular diabetes education). Data on diabetes distress, diabetes self‐efficacy, and diabetes self‐management were collected at baseline, 8 and 12 weeks. Hemoglobin A1c (HbA1c) was collected at baseline and 12 weeks. A generalized estimating equation analysis for repeated measures was used to determine intervention and time effects. As predicted, the nurse‐led MBSR therapy had a significant time‐by‐group interaction effect on diabetes distress total score (95% confidence interval [CI]: 0.58–0.77, p < 0.001), diabetes self‐efficacy (95% CI: −0.93 to −0.74, p < 0.001), diabetes self‐management (95% CI: −10.80 to −7.83, p < 0.001), and HbA1c levels (95% CI: 0.04–1.14, p = 0.03) in the intervention group compared with the control group over 12 weeks. This is the first nurse‐led MBSR therapy in a hospital setting that is feasible and has the potential to improve health outcomes. This approach may offer an innovative model to deliver MBSR therapy. A randomized controlled trial comparing the nurse‐led MBSR plus usual diabetes education with usual diabetes education along with a mechanism to equalize intervention attention between the groups is indicated. [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]

Objectives: Despite the various treatment approaches proposed for major depressive disorder (MDD), the right treatment protocol for different patients is not the same. Supplementation of L-carnitine to antidepressants has been recommended in some studies; however, different results have been reported. This study aimed to evaluate the effectiveness of adding L-carnitine to sertraline in the treatment of patients diagnosed with MDD. Material and Methods: This double-blind randomized controlled trial was conducted on 60 patients with MDD. The severity of the depressive disorder, as the primary research outcome, was assessed using the Beck depression inventory. The intervention group received 1000 mg of daily L-carnitine oral capsule along with 100 mg of sertraline; and the control group received a placebo (oral capsule containing 1000 mg of starch), along with 100 mg of sertraline every day. The primary outcome was assessed at baseline, the 3rd, and the 6th week. Results: Although depression score decreased in both groups over time, the difference between the two groups was not significant (P = 0.634). Three patients reported adverse side effects; however, the difference between the two groups was not significant (P = 0.554). Conclusion: Supplementation of L-carnitine to sertraline in patients with MDD did not show a significant effect on the improvement of depression severity. [ABSTRACT FROM AUTHOR]

Pivotal Response Treatment (PRT) is promising for children with Autism Spectrum Disorder (ASD), but more methodologically robust designed studies are needed. In this randomized controlled trial, forty-four children with ASD, aged 9–15 years, were randomly allocated to PRT (n = 22) or treatment-as-usual (TAU; n = 22). Measurements were obtained after 12- and 20-weeks treatment, and 2-month follow-up. PRT resulted in significant greater improvements on parent-rated social-communicative skills after 12 weeks treatment (p =.004, partial η2 = 0.22), compared to TAU. Furthermore, larger gains in PRT compared to TAU were observed on blindly rated global functioning, and parent-rated adaptive socialization skills and attention problems. Implications for clinical practice and suggestions for future research are discussed. [ABSTRACT FROM AUTHOR]

Background. Immune-related adverse events (irAEs) are of great interest and importance in clinical practice, and many deficiencies and controversies have been noted in the reporting of irAEs. Herein, we aimed to evaluate the current status of irAE reporting in randomized controlled clinical trials (RCTs) of PD-1/PD-L1 inhibitors and to attempt to explain and solve the current pitfalls associated with this reporting. Materials and Methods. We conducted a systematic review across multiple databases, including PubMed, Web of Science, Embase, and the Cochrane Library. The RCTs that compared PD-1/PD-L1 inhibitors with standard treatments were included. The Harms extension of the Consolidated Standards of Reporting Trials (CONSORT) was used to evaluate the completeness of irAE reporting. Results. A total of 44 articles and 23,759 patients were included in the analysis. The terminology of the irAEs changed over time (p = .01) and was different among immune checkpoint inhibitors (ICIs) (p = .005). Twenty-two of the studies provided a definition of irAE, but only four of them concretely addressed this definition. The incidence of any grade of irAEs ranged from 16.9% to 96%, whereas grade 3-4 irAE ranged from 2% to 23%. The RCTs with combined therapy exhibited a higher incidence of grade 3-4 irAEs (p = .012). Thirty-two studies reported irAEs in the control arms, whereas seven studies reported irAEs only in the experimental arms. Respiratory, endocrine, and gastrointestinal disorders were the most commonly reported irAEs. IrAEs were generally neglected in the introduction or conclusion sections in all of the study reviews and were never subjected to subgroup analyses. Moreover, withdrawals due to severe irAEs, as well as clarifications of the irAE collection methods, were also poorly reported. RCTs using combination therapies in the experimental arms were associated with a higher reporting quality (p = .032). However, the completeness of the reporting did not improve over the last 5 years (p = .076). Conclusion. The reporting of irAEs was inadequate, and there are still inconsistencies and controversies in the reporting of irAEs. In the future, authors should be encouraged to adhere to the Harms extension of the CONSORT statement. [ABSTRACT FROM AUTHOR]

Hypertension is one of the serious health issues worldwide and requires medications and lifestyle modifications to prevent its serious complications. Lifestyle modification requires health literacy which is an important factor for people with hypertension to manage themselves to control blood pressure. Health literacy is the cognitive and social skills of individuals to acquire, access to, understand, and use information to stay healthy. This randomized controlled trial aimed to examine the effectiveness of Health Education and Health Empowerment Program to improve health literacy in Thai adults with uncontrolled hypertension. Two sub-district health promoting hospitals in a province in the east of Thailand were randomly selected and assigned to an intervention hospital and a control hospital. Twenty participants in each hospital were randomly selected. Participants in the experimental group received a 4-week Program, whereas participants in the control group received only usual care. The Health Literacy for Hypertension Questionnaire was administered at baseline (week 0), immediate post-in- tervention (week 4) and at follow-up after 4 weeks of intervention completion (week 8). Two-way mixed ANOVA and repeated measures were used to analyze the data. The results indicated that participants in intervention group had a significantly higher health literacy mean scores than those in the control group at immediately post-intervention and follow-up period. The mean scores of health literacy in hypertension in the intervention group had significantly increased over time. These findings indicate the benefit of the program in improving health literacy among people with uncontrolled hypertension. Further testing of the program with participants in other provinces is needed to validate the results before implementation in practice. [ABSTRACT FROM AUTHOR]

Objective: The present study determined the feasibility and initial efficacy of a kindergarten‐based, family‐involved intervention in improving children's hand hygiene (HH) behaviors. Design: A cluster‐randomized controlled trial was performed, with a cluster defined as a kindergarten class. Sample: Participants were recruited from 20 classes in six kindergartens. A total of 289 children and their families were enrolled in the intervention group, and 293 children and their families were enrolled in the control group. Measurements: HH behavior and a related knowledge survey, as well as data on absences due to infection, were collected. Intervention: An 8‐week training session on HH for children and an education program combining a seminar and WeChat groups for parents were provided to participants in the intervention group. Results: Two HH behaviors of children, namely, HH after playing outside and 7‐stage HH compliance, were significantly different between the two groups after the intervention. The two HH behaviors and knowledge of infections of parents/legal guardians in the intervention group were better than those in the control group after the intervention. The number of absences due to infections in children was lower in the intervention group than in the control group. Conclusions: Kindergarten‐based, family‐involved interventions effectively improved the HH behavior of kindergarten children and decreased absences due to infections. [ABSTRACT FROM AUTHOR]

Background: Few randomized controlled trials with a midterm follow-up have compared matrix-assisted autologous chondrocyte transplantation (MACT) with microfracture (MFx) for knee cartilage lesions. Purpose: To compare the structural, clinical, and safety outcomes at midterm follow-up of MACT versus MFx for treating symptomatic knee cartilage lesions. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 48 patients aged between 18 and 50 years, with 1- to 4-cm2 International Cartilage Repair Society (ICRS) grade III to IV knee chondral lesions, were randomized in a 1:1 ratio to the MACT and MFx treatment groups. A sequential prospective evaluation was performed using magnetic resonance imaging (MRI) T2 mapping, the MOCART (magnetic resonance observation of cartilage repair tissue) score, second-look arthroscopic surgery, patient-reported outcome measures, the responder rate (based on achieving the minimal clinically important difference for the Knee injury and Osteoarthritis Outcome Score [KOOS] pain and KOOS Sport/Recreation), adverse events, and treatment failure (defined as a reoperation because of symptoms caused by the primary defect and the detachment or absence of >50% of the repaired tissue during revision surgery). Results: Overall, 35 patients (18 MACT and 17 MFx) with a mean chondral lesion size of 1.8 ± 0.8 cm2 (range, 1-4 cm2) were followed up to a mean of 6 years postoperatively (range, 4-9 years). MACT demonstrated significantly better structural outcomes than MFx at 1 to 6 years postoperatively. At final follow-up, the MRI T2 mapping values of the repaired tissue were 37.7 ± 8.5 ms for MACT versus 46.4 ± 8.5 ms for MFx (P =.003), while the MOCART scores were 59.4 ± 17.3 and 42.4 ± 16.3, respectively (P =.006). More than 50% defect filling was seen in 95% of patients at 2 years and 82% at 6 years in the MACT group and in 67% at 2 years and 53% at 6 years in the MFx group. The second-look ICRS scores at 1 year were 10.7 ± 1.3 for MACT and 9.0 ± 1.8 for MFx (P =.001). Both groups showed significant clinical improvements at 6 years postoperatively compared with their preoperative status. Significant differences favoring the MACT group were observed at 2 years on the KOOS Activities of Daily Living (P =.043), at 4 years on all KOOS subscales (except Symptoms; P <.05) and the Tegner scale (P =.008), and at 6 years on the Tegner scale (P =.010). The responder rates at 6 years were 53% and 77% for MFx and MACT, respectively. There were no reported treatment failures after MACT; the failure rate was 8.3% in the MFx group. Neither group had serious adverse events related to treatment. Conclusion: Patients who underwent MACT had better structural outcomes than those who underwent MFx at 1 to 6 years postoperatively. Both groups of patients showed significant clinical improvements at final follow-up compared with their preoperative status. MACT showed superiority at 4 years for the majority of the KOOS subscales and for the Tegner scale at 4 to 6 years. The MACT group also had a higher responder rate and lower failure rate at final follow-up. Registration: NCT01947374 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Aim: To explore the effects of an educational‐ counselling programme based on the precede–proceed model during pregnancy on preventing post‐partum depression. Design: A randomized clinical trial (RCT) study. Method: 130 pregnant women were selected and randomly assigned to intervention and control groups. Data collection was carried out using questionnaires of predisposing, reinforcing and enabling factors, GHQ and Edinburgh Postnatal Depression Scale (EPDS). The Education programme was designed and performed in each group in a given weekday through four 60‐minute sessions. The whole intervention lasted for one month in all groups. The participants in the control group were given routine pregnancy care. Data were gathered before and after the intervention in both groups. Results: Independent t test showed a significant difference between the two groups in terms of the mean score of predisposing, reinforcing, enabling factors and post‐partum depression (p <.05). Regression tests indicated predisposing, reinforcing, enabling factors and general health as the most important factors associated with post‐partum depression (p <.05). The results supported the effectiveness of the educational intervention on reducing post‐partum depression and showed that implementing these training during pregnancy leads to a reduced level of post‐partum depression. [ABSTRACT FROM AUTHOR]

Purpose The aim of this research was to study the effectiveness on return to work (RTW) of an early tailored work-related support intervention in patients diagnosed with curative gastrointestinal cancer. Methods A multicenter randomized controlled trial was undertaken, in which patients were assigned randomly to the intervention or the control group (usual care). The intervention encompassed three psychosocial work-related support meetings, starting before treatment. Five self-reported questionnaires were sent over twelve months of follow-up. Primary outcome was days until RTW (fulltime or partial) and secondary outcomes included work status, quality of life, work ability, and work limitations. Descriptive analysis, Kaplan–Meier analysis, relative risk ratio and linear mixed models were applied. Results Participants (N = 88) had a mean age of 55 years; 67% were male and the most common cancer type was colon cancer (66%). Of the participants, 42 were randomized to the intervention group. The median time from sick leave until RTW was 233 days (range 187–279 days) for the control group, versus 190 days (range 139–240 days) for the intervention group (log-rank p = 0.37). The RTW rate at twelve months after baseline was 83.3% for the intervention group and 73.5% for the control group. Work limitations did statistically differ between the groups over time (p = 0.01), but quality of life and work ability did not. Conclusion Patients in the intervention group seem to take fewer days to RTW, albeit not to a statistically significant extent. Trial registration Trial NL4920 (NTR5022) (Dutch Trial Register https://www.trialregister.nl) [ABSTRACT FROM AUTHOR]