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Background: Standardization of health systems often hinders client‐centered care. This study investigates whether allowing more flexibility in the planning range of the Dutch home‐based postpartum care service improves its quality of care, as innovative approach to client‐centered care. Methods: A randomized controlled trial was conducted (2017–2019), in which pregnant women who intended to breastfeed were assigned into two groups (1:1). The intervention group was allowed to receive care up to the 14th‐day postpartum, instead of the first 8–10 consecutive days ("usual care"). Primary outcome measure was the proportion of newborns still receiving exclusively breastmilk on final caring day of the service. This so‐called successful breastfeeding rate is currently used by the Dutch health sector to measure the quality of care. Secondary outcome measures were self‐care experience, overall care experience, and exclusive breastfeeding duration rate. Results: Based on data from 1275 participants, there was no difference in exclusive breastfeeding on final caring day (86,7% intervention group vs. 88,9% control group, RR: 1.03, 95% CI: 0.98–1.07). Both groups showed similar self‐care experiences. Women in the intervention group had slightly poorer overall care experience and lower exclusive breastfeeding duration rates. Conclusions: This study found no effect on the quality of care when allowing more flexibility in the planning range of home‐based postpartum care. Women can, therefore, be offered more flexibility to suit them. Given the confusion in interpreting the sector's current main quality indicator, we call for an inclusive dialogue on how to best measure the quality of home‐based postpartum care. [ABSTRACT FROM AUTHOR]

Background: In an Australian randomized controlled trial (RCT), two techniques for intrapartum fetal surveillance were compared: ST analysis (STan) as an adjunct to cardiotocography (CTG), compared with CTG alone. The aim was to determine whether CTG + STan could reduce emergency cesarean birth rates while maintaining or improving neonatal outcomes. Secondary aims were to compare clinical, economic, and psychosocial outcomes. The purpose of this paper was to present psychosocial outcomes from one cohort enrolled in the trial. Methods: The study was conducted at one tertiary referral hospital. Participants who had taken part in the trial from the outset were invited to complete a questionnaire between March 2018 and January 2020, approximately 8 weeks after giving birth. Outcomes included depression, psychological distress, health‐related quality of life, and infant feeding practices. Analysis was by intention to treat. Results: N = 207/527 participants completed the questionnaire (n = 113, STan; n = 94, CTG alone). Overall, no statistically significant or clinically meaningful differences were found in the two groups for symptoms of depression, psychological distress, quality of life, or infant feeding. A statistically significant difference was observed for the subscale of pain‐discomfort, where scores were higher on average in the CTG alone arm relative to that in the CTG + STan arm. Conclusions: Although STan as an adjunct to CTG constitutes a different clinical technology from CTG alone, both monitoring types appeared to produce similar results in terms of postnatal psychosocial outcomes for women. Findings from this study provide service users and staff with a comprehensive assessment of STan that can be used to make evidence‐informed decisions about monitoring options should STan become more widely available. [ABSTRACT FROM AUTHOR]

Background: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results: The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271. [ABSTRACT FROM AUTHOR]

Objectives: This study was conducted in order to determine the effect on halitosis and the antibacterial effect against halitosis‐causing bacteria of the mouthwash made of the natural material, Glycyrrhiza uralensis (G. uralensis) extract. Materials and Methods: A randomized, double‐blind, placebo‐controlled study was conducted on 60 patients who visited M dental clinic located in Busan, South Korea, excluding those with systemic disease that may induce halitosis. There were 30 patients classified to the saline gargle group and the remaining 30 patients were classified to the G. uralensis extract gargle group. In addition, their level of halitosis and halitosis‐causing bacteria were measured. They visited the dental clinic on a fasted state at baseline before gargle application (Baseline), immediately after gargle application (Treatment) and 5 days after gargle application (After 5 Days). For clinical indicators, participants were tested for halitosis and bacteria immediately after waking up without brushing their teeth and without hydration. Results: The prevalence of halitosis decreased in the G. uralensis extract gargle group compared to the saline gargle group at Treatment and After 5 Days. In cases with pseudo halitosis, there was a significant decrease in halitosis‐causing bacteria when G. uralensis extract gargle was applied (p < 0.05). Conclusions: It was identified that using a mouthwash made with G. uralensis extract is effective for halitosis improvement and reduction of halitosis‐causing bacteria. Therefore, using a mouthwash containing G. uralensis extract, it will be effective in improving bad breath and oral hygiene will be possible. [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]

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]

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]

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]

Children's burns are a major public health concern due to their long‐term physical, psychological, and social impacts, as well as their high financial burden. This study aimed to evaluate the effectiveness of a smartphone‐based educational program on outcomes of children with severe burns. This study was designed as a double‐blinded, randomized controlled trial (RCT) to test the effectiveness of a developed mobile application. A total of 93 participants were included in the final analysis. The participants were randomly assigned to either the intervention or control groups. Participants in both groups received usual self‐care training at discharge, but those in the intervention group used an Android‐based application for 2 months. The primary goal of the burn application was scar recovery, and the secondary goals were to increase child caregivers' satisfaction rate and decrease unplanned hospital readmissions. Data collection was conducted using valid and reliable questionnaires. Data were analysed using SPSS software. The study showed that the mobile application significantly affected the frequency of patient visits to the burn clinic and the satisfaction of caregivers of children with burns with the treatment process (p‐value <0.05). Also, there was a significant relationship between the duration of application use and wound healing status ((p‐value <0.001). These findings suggest that smartphone‐based educational programs can be valuable for optimizing care for children with severe burns. Further research is warranted to explore the long‐term impact of this intervention and its potential application in different healthcare settings. [ABSTRACT FROM AUTHOR]

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty‐five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers. [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]

Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16‐week randomized double‐blind, placebo‐controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS‐AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post‐treatment. Results: Both groups were comparable in age (mean = 74 ± 7.2 years in the placebo group and 75 ± 7.4 in the intervention group) and in other demographics. Sixty‐two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS‐cog) was the primary outcome. By week 16, the mean ADAS‐cog reduced from 24.48 to 20.30 (mean reduction = 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reduction = 1.18) for those in the placebo group. The difference in mean reduction of ADAS‐cog was −3.00 (95% confidence interval [CI] = −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t‐scores) pre‐ and post‐treatment between the intervention group (n = 7) and the placebo group (n = 11) was statistically significant (P < 0.001). Conclusion: In this randomized, double‐blind placebo‐controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants. [ABSTRACT FROM AUTHOR]

Aim: Hiesho is a condition characterized by having a cold sensation in the hands or feet (i.e., sensitivity of the hands or feet to cold). This condition is common among Japanese women and is an important health problem. In this study, we aimed to evaluate a hiesho intervention program for nurses called "Preventing Hiesho: Intervention Program for Educating Nurses" in terms of its effectiveness in improving the knowledge and perceptions of nurses about the importance of hiesho care. Methods: A total of 130 nurses from Japanese hospitals and clinics providing prenatal care participated in our randomized controlled trial. Sixty‐eight nurses participated in the "Preventing Hiesho: Intervention Program for Educating Nurses" for 2 weeks (intervention group). Sixty‐two nurses received a pamphlet on hiesho care (control group). The responses of the participants to the questionnaire survey were collected by postal mail. An intention‐to‐treat analysis of the results was conducted. Results: One week after the implementation of the web‐based learning program, the scores of knowledge and perceptions of the importance of administering hiesho care were significantly higher in the intervention group than in the control group. Conclusions: A 2‐week web‐based learning program for educating nurses on preventing hiesho significantly improved their knowledge and perceptions of the importance of hiesho care. [ABSTRACT FROM AUTHOR]

Purpose This study was conducted to systematically examine the effect of decision support systems (DSSs) applied to patients with cancer on pain severity. Review methods: Systematic review and meta‐analysis. A search was done on Web of Science, Science Direct, PubMed, ProQuest, EBSCOhost/CINAHL Complete, Scopus, Springer Link, Cochrane Library, and Ovid databases, which covered a period until September 2021. Meta‐analysis of the data was conducted on the CMA 3 software package. Comprehensive reviews were conducted by two independent researchers in line with the PICOS criteria. The study was conducted according to the PRISMA checklist. Findings Five randomized controlled trials with 1.880 participants were included in this systematic review and meta‐analysis. In the study, visits, consultations, simulation of patient outcomes, telephone support, and email applications were employed for periods ranging from 6 weeks to 6 months. The evaluation of the meta‐analysis results indicated that DSSs had positive effects on pain severity in patients with cancer (Hedge's g = 0.22; p < 0.001). Conclusion: The findings of this systematic review and meta‐analysis show that DSSs can be used as an effective and comfortable technological application in reducing the severity of pain in patients with cancer. Clinical relevance: The use of DSSs for pain severity in patients with cancer is an effective method. In line with the findings of this systematic review and meta‐analysis, awareness and knowledge levels of all health disciplines about DSSs will increase. It is believed that the use of DSSs to improve patient‐centered care will be guiding. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study evaluated the effect of the school‐based intervention Charge Your Brainzzz on adolescents' social‐cognitive determinants, sleep hygiene and sleep duration and quality. METHODS: A cluster‐randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post‐intervention (T1) and ±3 months post‐intervention (T2). Mixed model analyses were performed to estimate the effects on social‐cognitive determinants, sleep hygiene, and sleep outcomes. RESULTS: The intervention increased sleep knowledge post‐intervention (b = 1.91; 95%CI: 1.22‐2.60) and at follow up (b = 1.40; 95%CI: 0.70‐2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01‐0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01‐0.22) post‐intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes. CONCLUSIONS: The intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep‐related behaviors, and adolescents' social and physical environment. CLINICAL TRIAL REGISTRATION: Trial name: Evaluation of the school‐based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918. [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]

Background: Compensational movement patterns in hip osteoarthritis (HOA) are associated with hip dysfunction. Basic Body Awareness Therapy (BBAT) promotes functional movement quality and might, accordingly, be beneficial in HOA. Objective: To examine the outcomes of BBAT compared to standard care in people with HOA after first receiving patient education (PE). Study Design: A prospective, assessor‐blinded, and block‐randomized controlled trial. Methods: Community‐living adults with HOA participating in PE were randomly allocated to an intervention group receiving BBAT in groups (12 sessions offered once a week), or a comparison group. Data at baseline (pretest) and at 6 months (posttest) were analyzed. Primary outcomes were pain during walking assessed by the Numeric Rating Scale (NRS) and function by the Hip Osteoarthritis Outcome Score, subscale ADL (HOOS A). Secondary outcomes addressed physical capacity, movement quality, and self‐reported aspects of function and health. Results: At pretest, there were no significant differences in demographic and test data between the intervention (n = 51) and the comparison (n = 50) group. Forty‐one intervention and 45 comparison participants completed the posttest. At posttest, no significant differences in change between groups were found on NRS (p = 0.694, effect size (ES) = 0.02) or HOOS A (p = 0.783, ES = 0.07). Among secondary outcomes, movement quality improved significantly more (p < 0.001, ES = 0.84) in the intervention group. Compliance with BBAT varied substantially. Per‐protocol analysis showed changes in favor of the intervention group for self‐efficacy (p = 0.049, ES = 0.36), health (p = 0.037, ES = 0.44), and function (p = 0.029, ES = 0.53) when only intervention participants who completed at least 10 sessions of BBAT were included. Conclusions: BBAT was not found to be a more effective treatment modality than self‐initiated standard care to reduce pain during walking and improve daily functioning in people with HOA. Movement quality was significantly more improved in participants receiving BBAT, and improvement in other health aspects was associated with sufficient therapy compliance. [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]

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: RobotReviewer is a machine learning system for semi‐automated assistance in risk of bias assessment. The tools's performance in randomized controlled trials (RCTs) in the field of nursing remains unknown. We aimed therefore to evaluate the agreement in risk of bias assessment between RobotReviewer and human reviewers. Design: Evaluation study using a retrospective diagnostic design. Methods: We used RobotReviewer as the index test and human reviewers' risk of bias assessment reported in Cochrane reviews as the reference test. A convenience sample of electronically available English‐language full texts of RCTs included in Cochrane reviews with nurs* in the title were eligible for inclusion. In this context, we assessed random sequence generation, allocation concealment, and blinding (personnel or participants and assessors) corresponding to Cochrane risk of bias version 2011. Two independent research teams performed and double‐checked data extraction and analysis. We calculated sensitivity, specificity, receiver operating characteristic (ROC) curve, the area under the ROC curve, predictive values, observed percentage of agreement, and Cohen's kappa (including confidence intervals, if applicable). Findings: The selection process yielded 190 RCTs published between 1958 and 2016 in 23 Cochrane reviews published between 2000 and 2018. Missing assessments of risk of bias domains in Cochrane reviews or RobotReviewer yielded varying sample sizes per risk of bias domain. Sensitivity ranged from 0.44 to 0.88 and specificity from 0.48 to 0.95. Positive predictive value was highest for allocation concealment (0.79) and lowest for blinding assessors (0.25). Cohen's kappa was moderate for randomization (0.52), allocation concealment (0.60), and for blinding of personnel/patients (0.43). Blinding of outcome assessors had only slight agreement (0.04). Conclusions: This is the first evaluation of risk of bias assessment by RobotReviewer in RCTs included in nursing‐related Cochrane reviews. It yielded a moderate degree of agreement with human reviewers for randomization and allocation concealment, and an adequate sensitivity for detecting low risk of selection bias. Clinical Relevance: Based on our results, using the RobotReviewer for risk of bias assessment in RCTs can be supportive in some risk of bias domains. However, human reviewers should supervise the semi‐automated assessment process. [ABSTRACT FROM AUTHOR]

This randomized controlled trial (RCT) aimed to pilot the newly developed manualized and monitored systemic therapy (ST) for social anxiety disorder (SAD), as compared to manualized and monitored cognitive behavioral therapy (CBT). We conducted a prospective multicenter, assessor‐blind pilot RCT on 38 outpatients (ICD F40.1; Structured Clinical Interview for DSM (SCID); Liebowitz Social Anxiety Scale, LSAS‐SR >30). The primary outcome was level of social anxiety (LSAS‐SR) at the end of treatment. A total of 252 persons were screened, and 38 patients were randomized and started therapy (CBT: 20 patients; ST: 18 patients; age: M = 36 years, SD = 14). Within‐group, simple‐effect intent‐to‐treat analyses (ITT) showed significant reduction in LSAS‐SR (CBT:d = 1.04; ST:d = 1.67), while ITT mixed‐design ANOVA demonstrated the advantage of ST (d = 0.81). Per‐protocol analyses supported these results. Remission based on reliable change indices also demonstrated significant difference (LSAS‐SR: 15% in CBT; 39% in ST;h: 0.550), supported by blind diagnosticians' ratings of those who completed therapy (SCID; 45% in CBT, 78% in ST,p =.083). No adverse events were reported. CBT and ST both reduced social anxiety, supporting patient improvement with the newly developed ST for SAD; this has yet to be verified in a subsequent confirmatory RCT. [ABSTRACT FROM AUTHOR]

Background: Training conversation partners of people with aphasia who use facilitative communication strategies is one method that can improve access to healthcare for people with aphasia. However, the efficacy of communication partner training (CPT) has been investigated almost exclusively in the context of face‐to‐face (F2F) delivery. Online training may offer more cost‐effective and accessible options to a wider range of conversation partners, including student healthcare professionals. Aims: To conduct a pilot randomized controlled trial with student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group) on outcomes relating to attitudes and knowledge of aphasia. Methods & Procedures: A 45‐min introductory aphasia CPT program was developed using the theories and techniques of Supported Conversations for Adults with Aphasia (SCA)™. A total of 30 first‐year undergraduates studying occupational therapy at The University of Sydney were randomly allocated to one of three conditions: online CPT delivery, F2F delivery or delayed training control (no program). Outcomes measures included pre‐post‐testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey. Outcomes & Results: A significant difference existed for the AASK survey pre‐post‐change scores between the online, F2F and control groups (χ2(2) = 20.038, p = 0.000). Post‐hoc analysis revealed that, compared with the control (Ctrl) group, participants in both the online and F2F groups had significantly higher knowledge of aphasia (Online versus Ctrl: p = 0.000; F2F versus control: p = 0.002), knowledge of facilitative strategies (Online versus Ctrl: p = 0.000; F2F versus Ctrl: p = 0.002), and positive attitudes towards aphasia (Online versus Ctrl: p = 0.031; F2F versus Ctrl: p = 0.032). No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000). Conclusions and Implications: The results from this pilot randomized controlled trial indicate that online delivery of the 45‐min introductory CPT is equally as efficacious as F2F delivery, and thus may be a viable mode of delivery for future aphasia CPT programs. These pilot results pave the way for a larger study that will comprehensively evaluate the efficacy of an online aphasia CPT program for improving attitudes, knowledge and skills in a broad range of student healthcare professionals. What this paper addsWhat is already known on this subjectThe efficacy of F2F CPT for aphasia is well established. Online delivery of CPT programs may offer more cost‐effective and accessible services when compared with F2F approaches; however, there is a need to explore the efficacy of online programs.What this paper adds to existing knowledgeThe 45‐min online aphasia CPT program was found to be efficacious for improving student healthcare professionals' knowledge and attitudes towards aphasia and communication, and produced equally successful outcomes when compared with F2F delivery. This is the first study to report the efficacy of an online CPT program that is aligned with SCA for use with student healthcare professionals that also uses a self‐report outcome measure with validated psychometric properties.What are the potential or actual clinical implications of this work?Online CPT programs may be useful in both clinical and education contexts to support improved efficiency of services and to enhance communication environments for people with aphasia in healthcare contexts. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to develop and evaluate the effectiveness of using e‐learning on smartphones to provide dental hygiene education on dental treatment procedures. Methods: This was a randomized controlled trial. Two‐hundred ninety‐three dental hygiene students in four universities, one junior college and one technical school took a preliminary examination, and based on the results, participants in each school were randomly divided into two groups, a test or control group. Both groups took pre‐ and post‐examinations at a 4‐week interval. The test groups learned dental treatment procedures and four‐handed techniques with interactive learning materials using smartphones. The learning materials allowed them to watch videos of dental treatments. The control groups were not provided any learning material. Results: Results of all schools combined showed that the changes from pre‐ to post‐examination scores in the test groups were significantly higher than those of the control groups (p <.05). Post‐examination scores were significantly higher than pre‐examination scores in the test groups in all schools (p <.05). Also, post‐examination scores of the test groups were significantly higher than those of the control groups (p <.05). The changes from pre‐ to post‐examination scores in the test groups of two schools were significantly higher than those of control groups (p <.05). Post‐examination scores of the control groups in two schools were significantly higher than pre‐examination scores (p <.05). Conclusions: Learning dental treatment procedures through e‐learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four‐handed techniques. [ABSTRACT FROM AUTHOR]

Aim: This study was designed to investigate the longitudinal effect of participating in a self‐management program (SMP) on renal function control in patients receiving hemodialysis. Methods: This randomized controlled trial enrolled a total of 58 patients at the hemodialysis center of a teaching hospital in Taiwan. The control group (n = 30) received the usual care and the experimental group (n = 28) received a 4‐week SMP intervention. The results of the follow‐up on the longitudinal data at 3, 6, and 9 months showed that the renal function indices, potassium and phosphorus levels, and interdialytic weight gain were significantly better than at the pre‐test for the experimental group. Results: In terms of the interaction between group and time, the potassium level dropped significantly below the pre‐test value only after 3 months (B = −0.31, SE = 0.15, p =.044), suggesting that the post‐test potassium level had significantly decreased after 3 months. In terms of the interaction between group and time, the phosphorus level dropped significantly below the pre‐test value only after 6 months (B = −0.53, SE = 0.28, p =.050), suggesting that the post‐test phosphorus level significantly decreased after 6 months. Finally, the intervention could effectively control the weight change between dialysis sessions for up to 9 months (B = −1.34, SE = 0.30, p <.001). Conclusions: The SMP intervention decreased potassium and phosphorus levels and helped control interdialytic weight gain in patients undergoing hemodialysis. [ABSTRACT FROM AUTHOR]

Background: The measurement and interpretation of patient experience is a distinct dimension of health care quality. The Midwives @ New Group practice Options (M@NGO) randomized control trial of caseload midwifery compared with standard care among women regardless of risk reported both clinical and cost benefits. This study reports participants' perceptions of the quality of antenatal care within caseload midwifery, compared with standard care for women of any risk within that trial. Methods: A trial conducted at two Australian tertiary hospitals randomly assigned participants (1:1) to caseload midwifery or standard care regardless of risk. Women were sent an 89‐question survey at 6 weeks postpartum that included 12 questions relating to pregnancy care. Ten survey questions (including 7‐point Likert scales) were analyzed by intention to treat and illustrated by participant quotes from two free‐text open‐response items. Results: From the 1748 women recruited to the trial, 58% (n = 1017) completed the 6‐week survey. Of those allocated to caseload midwifery, 66% (n = 573) responded, compared with 51% (n = 444) of those allocated to standard care. The survey found women allocated to caseload midwifery perceived a higher level of quality care across every antenatal measure. Notably, those women with identified risk factors reported higher levels of emotional support (aOR 2.52 [95% CI 1.87‐3.39]), quality care (2.94 [2.28‐3.79]), and feeling actively involved in decision‐making (3.21 [2.35‐4.37]). Conclusions: Results from the study show that in addition to the benefits to clinical care and cost demonstrated in the M@NGO trial, caseload midwifery outperforms standard care in perceived quality of pregnancy care regardless of risk. [ABSTRACT FROM AUTHOR]

Objectives: This single‐centre, controlled, randomized, double‐blinded clinical study in parallel groups was performed to assess the efficacy of an experimental toothpaste on plaque and gingivitis. Methods: In adult subjects with gingivitis, amine fluoride/stannous chloride toothpaste (test) and monofluorophosphate toothpaste (control) were applied twice daily by regular toothbrushing at home. Evaluations of plaque index (PI), gingival index (GI), modified sulcus bleeding index (mSBI) and safety took place at baseline and after 3 and 12 weeks of study product use. After study completion, all subjects received a dental prophylaxis. A descriptive statistical analysis included means and standard deviations. Unpaired t tests compared index reductions between groups at a significance level of 0.05. Results: Intention‐to‐treat analysis included 240 out of 241 subjects. Baseline mean PI was reduced by 0.87 ± 0.35 in the test group and by 0.65 ± 0.41 in the control group. Within‐group differences and between‐group differences in index reduction were statistically significant (P < 0.001). Mean GI and mSBI were reduced significantly over time (P < 0.001) with no clinically meaningful differences between groups. Conclusions: Both toothpastes reduced plaque and gingivitis statistically significant and clinically meaningful over 12 weeks. Compared to the control toothpaste, application of the amine fluoride/stannous chloride toothpaste led to a clinically meaningful and more pronounced plaque reduction. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of an education program for mid‐level Japanese public health nurses (PHNs) to improve their competencies in program planning, which will fulfill community health needs. Design: Randomized control trial. Sample: During 2017, 103 PHNs with 5–20 years of PHN work experience in Japan were enrolled and randomly allocated to the intervention (n = 51) or control group (n = 52). Measurements: The primary outcome measured competency in program planning based on Competency Measurement of Creativity for PHNs (CMC), knowledge, and skills regarding program planning. Intervention: Six web‐based learning modules followed by two face‐to‐face group sessions. Results: The PHN participants averaged about 12 years of experience. In the intervention group, 25 PHNs completed all modules (49.0%). Post intervention, there were no statistically significant differences among any between‐group CMC scores. However, the intervention group's CMC 3 score was significantly higher than that of the control group of ≥12 years of experience. Total knowledge and skill scores also improved significantly in the intervention group compared with the control group. Conclusions: The results suggest that PHNs with ≥12 years of experience are a suitable target of this educational program, and should play a key role in program planning. [ABSTRACT FROM AUTHOR]

Sleep disturbance is a significant problem affecting around 50% of cancer patients. Non‐pharmacological interventions can be used to improve sleep quality in cancer patients, but little is known about the feasibility, acceptability, and effectiveness of auricular point acupressure (APA) to reduce sleep disturbance in women with ovarian cancer undergoing chemotherapy. A pilot randomized controlled trial was conducted at a publicly funded hospital in southern Taiwan. Fifty‐five eligible women were approached and 47 women participated. Women randomly assigned to the control group (n = 24) received sleep hygiene practices alone. Women in the intervention group (n = 23) received sleep hygiene practices and APA treatment which involved gentle fingertip pressure at acupoints on the external ear. The Pittsburgh Sleep Quality Index (PSQI) was completed at four time points. Forty women completed the trial giving a retention rate of 85%. Women receiving the intervention reported a 65% reduction in sleep disturbance according to PSQI global scores from Time 1 (mean = 13.2) to Time 2 (mean = 4.65) after 4 weeks of APA treatment. There was a further 10% decrease in PSQI scores at Time 3 (mean = 4.21) after 6 weeks of APA treatment. Compared to controls, women receiving APA had significantly lower PSQI mean global scores at both Time 2 and Time 3 (p < .001). APA treatment for women with ovarian cancer produced significantly improved sleep. Participants found the procedure easy to perform. Pilot findings support the feasibility of a longitudinal study with a larger, representative sample. [ABSTRACT FROM AUTHOR]

Abstract: This study aimed to evaluate the impact of peer counselling on early initiation of breastfeeding (EIBF) and exclusive breastfeeding (EBF) rates for mother–infant pairs living in urban slums, Dhaka, Bangladesh. This randomized controlled trial enrolled 350 mother–infant pairs from selected slums between September 2014 and July 2016. The women assigned to intervention group received peer counselling from locally recruited, trained community female volunteers starting in third trimester of pregnancy until 6 months after delivery; control group received no intervention. EIBF, any liquids given after birth, and EBF were compared between groups. Follow‐up was scheduled at enrolment, following childbirth, and every 2 months up to 6 months after delivery. Multiple logistic regressions were used to assess the effect peer counselling and other associated factors on EIBF and EBF practices. EIBF rate was higher in the intervention group than in the control group (89.1% vs. 77.4%, p = .005). More mothers in intervention group were exclusively breastfeeding at 5 months than mothers in the control group (73% vs. 27%, p < .005). Control mothers were twice as likely to not practice EIBF compared with intervention mothers (adjusted odds risk [aOR]: 2.53, CI [1.29, 4.97], p = .007). Overall, caesarean section was associated with an 8.9‐fold higher risk of not achieving EIBF (aOR: 8.90, CI [4.05, 19.55], p < .001). Intervention mothers were 5.10‐fold more likely to practice EBF compared with control mothers (aOR: 5.10, CI [2.89, 9.01], p < .001) at 5 months. This study demonstrates peer counselling can positively influence both EIBF and EBF among mothers living in urban area. [ABSTRACT FROM AUTHOR]

Abstract: Background and purpose: Patients with hip osteoarthritis have impairments in muscle function (muscle strength and power) and hip range of motion (ROM), and it is commonly believed that effective clinical management of osteoarthritis should address these impairments to reduce pain and disability. Therefore, the purpose of this study was to compare the short‐ and long‐term effects of 4 months of physiotherapist‐supervised strength training, physiotherapist‐supervised Nordic Walking (NW), or unsupervised home‐based exercise (HBE) on muscle function and hip ROM in patients diagnosed with hip osteoarthritis. Methods: Secondary outcome analyses from an observer‐blinded three‐armed parallel‐design randomized controlled trial in 60+‐year‐old patients with clinical hip osteoarthritis (American College of Rheumatology criteria) who were not on a waiting list for hip replacement. One hundred and fifty‐two patients were randomized to either 4 months of physiotherapist‐supervised, moderate, progressive, strength training (n = 50), physiotherapist‐supervised NW (n = 50), or unsupervised HBE (n = 52). Maximal isometric hip and thigh muscle strength and leg extensor power and active hip ROM were assessed at baseline 2, 4, and 12 months. Results: Intention‐to‐treat‐analyses did not show any significant between‐group differences for improvements in muscle strength and power or ROM at any time points. Short‐term significant (p < .05) increases in muscle strength were present in the physiotherapist‐supervised exercise groups and in the long‐term for muscle power in the NW‐group. All exercise modes resulted in significant increases of ROM but long‐term improvements were only shown for NW and HBE. Discussion: Four months of physiotherapist‐supervised, progressive, moderate, and strength training was less effective than hypothesized for improving muscle strength and power in patients with hip osteoarthritis who are not awaiting hip replacement. Our results may indicate that in these patients, improvements in disability are not necessarily dependent on improvements in strength and power or ROM. [ABSTRACT FROM AUTHOR]

Abstract: Background and purpose: Pneumonia is the most important respiratory problem in low‐to‐middle income countries. Airway clearance therapy continues to be used in children with pneumonia and secretion retention; however, there is lack of evidence to support or reject this treatment. This study aimed to investigate the feasibility of a randomized controlled trial (RCT) on the efficacy and safety of assisted autogenic drainage (AAD) compared to standard nursing care in children hospitalized with uncomplicated pneumonia. Methods: A single‐blinded pilot RCT was conducted on 29 children (median age 3.5 months, IQR 1.5–9.4) hospitalized with uncomplicated pneumonia. The intervention group received standard nursing care with additional bi‐daily AAD, for 10 to 30 min. The control group only received standard nursing care, unless otherwise deemed necessary by the physician or physiotherapist. The primary outcome measure was duration of hospitalization. The secondary outcome measures included days of fever and supplemental oxygen support; respiratory rate (RR) and heart rate adjusted for age; RR and oxygen saturation pre‐, post‐, and 1‐hr post‐treatment; oxygen saturation; adverse events; and mortality. Results: No difference was found for duration of hospitalization (median 7.5 and 7.0 days for the control and intervention groups, respectively); however, Kaplan–Meier analysis revealed a strong tendency towards a shorter time to discharge in the intervention group (p = .06). No significant differences were found for the other outcome measures at time of discharge. No adverse events were reported. Within the intervention group, a significant reduction in RR adjusted for age was found. Discussion: As no adverse events were reported, and AAD did not prolong hospitalization; AAD might be considered as safe and effective in young children with uncomplicated pneumonia. However, a larger multicentred RCT is warranted to determine the efficacy of AAD compared to standard nursing care. [ABSTRACT FROM AUTHOR]

Abstract: Aim: We aimed to assess the use of metformin (MTF) in the prevention of gestational diabetes mellitus (GDM) in patients with pregestational insulin resistance (PIR). Methods: A double blind, multicenter, randomized trial was carried out in patients with a history of PIR and pregestational MTF treatment. Groups were allocated either to MTF 1700 mg/day or placebo. Patients were recruited between 12+0 and 15+6 gestational weeks, and treatment was extended until week 36. A multiple logistic regression analysis was applied to determine the relation between the use of metformin and the development of GDM. Results: One hundred and forty one patients were randomized (68 patients in the MTF group and 73 in the placebo group). A total of 30 patients withdrew from the study during follow‐up. Administration of MTF was not associated with a decrease in the incidence of GDM as compared to placebo (37.5% vs 25.4%, respectively; P = 0.2). Moreover, MTF administration was associated with a significant increase in drug intolerance as compared to placebo (14.3% vs 1.8%, respectively; P = 0.02). Conclusion: The use of MTF is not effective in prevention of GDM in populations with PIR. The use of MTF shows a significantly higher frequency of drug intolerance than placebo. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to investigate whether twice-daily use of a rotating-oscillating power toothbrush (Oral-B Professional Care 1000™) in nursing home ( NH) residents over a 6-week period, compared to usual care (UC), would reduce periodontal inflammation. Methods In this repeated measures single-blinded randomized controlled trial, 59 residents of one NH in Winnipeg, Canada, were randomized to receive either twice-daily tooth brushing with a rotating-oscillating power toothbrush ( PB) or UC by caregivers. Consent was obtained from residents or their proxies. Participants had some natural teeth, periodontal inflammation, non-aggressive behaviour, no communicable diseases, were non-smokers and non-comatose. Outcomes were measured at baseline and 6 weeks, which included: inflammation ( MGI, Lobene), bleeding ( PBI, Loesche) and Plaque (Turesky). Comparisons of group changes in outcomes were analysed using an ANOVA with a repeated measure. Results Of 59 original study participants, one withdrew, one died prior to study commencement and three died before study completion. All oral parameters improved significantly for the remaining 54 residents over time ( P<.0001), with no differences between groups. Conclusions These results demonstrate that it is possible for caregivers to improve periodontal inflammation of residents over a 6-week period. Despite no significant group differences, periodontal inflammation of all study participants improved significantly, particularly in the reduction of bleeding, a direct measure of periodontal inflammation, which is a unique finding. [ABSTRACT FROM AUTHOR]

Background Shared decision making is an important component of patient-centred care and decision aids are tools designed to support patients' decision making and help patients with depression to make informed choices. Objective The study aim was to assess the effectiveness of a web-based decision aid for patients with unipolar depression. Design Randomized controlled trial. Setting and participants Adults diagnosed with a major depressive disorder and recruited in primary care centres were included and randomized to the decision aid (n=68) or usual care (n=79). Intervention Patients in the decision aid group reviewed the decision aid accompanied by a researcher. Outcome measures Knowledge about treatment options, decisional conflict, treatment intention and preference for participation in decision making. We also developed a pilot measure of concordance between patients' goals and concerns about treatment options and their treatment intention. Results Intervention significantly improved knowledge ( P<.001) and decisional conflict ( P<.001), and no differences were observed in treatment intention, preferences for participation, or concordance. One of the scales developed to measure goals and concerns showed validity issues. Conclusion The decision aid 'Decision making in depression' is effective improving knowledge of treatment options and reducing decisional conflict of patients with unipolar depression. More research is needed to establish a valid and reliable measure of concordance between patients' goals and concerns regarding pharmacological and psychological treatment, and the choice made. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effects of a hospital-community partnership transitional program among patients with coronary heart disease. Methods: This was a randomized controlled trial with 236 patients who were randomized into two groups. The patients in the control group received the usual care. In contrast, the patients in the study group received the transitional care program. The data were collected at the baseline, 30 days, and 90 days after discharge. The primary outcomes were the 30 and 90 day readmission rates after discharge. The secondary outcomes included the quality-of-care transitions, medicine adherence, and chronic disease self-efficacy. Results: The findings indicated that: (i) the patients in the study group reported significantly lower 30 and 90 day readmission rates after their discharge than those in the control group; (ii) statistically significant differences were found in the quality-of-care transitions at 30 days postdischarge between the two groups as the patients in the study group reported significantly higher quality-of-care transitions, compared to those in the control group; and (iii) the patients in the study group reported significantly higher scores in medication adherence and chronic disease self-efficacy at 30 and 90 days after discharge than those in the control group. Conclusion: This study is an original effort to establish and evaluate a hospital-community partnership transitional care program in patients with coronary heart disease in China and the findings have demonstrated its effects. [ABSTRACT FROM AUTHOR]

This study was conducted to determine and compare the effectiveness of nature sounds and relaxation exercises for reducing preoperative anxiety. A repeated measures randomized controlled trial design was used. We divided 159 preoperative patients into three groups: nature sounds ( n = 53), relaxation exercises ( n = 53), and control groups ( n = 53). We evaluated anxiety using the visual analog scale and state anxiety inventory scores immediately before, immediately after, and 30 min after interventions in nature sounds and relaxation exercises groups, and silent rest in the control. We found no differences between the measurement values in the intervention groups, but we did observe a difference between the intervention and control groups. The two interventions were similarly effective in reducing preoperative anxiety. These simple and low-cost interventions can be used to reduce preoperative anxiety in surgical clinics. [ABSTRACT FROM AUTHOR]

Background Adapted parenting support may alleviate the high levels of parenting stress experienced by many parents with intellectual disabilities. Methods Parents with mild intellectual disabilities or borderline intellectual functioning were randomized to experimental ( n = 43) and control ( n = 42) conditions. Parents in both groups received care-as-usual. The experimental group also received an adapted version of video-feedback intervention for positive parenting and learning difficulties ( VIPP- LD). Measures of parenting stress were obtained pre-test, post-test and 3-month follow-up. Results Randomization to the experimental group led to a steeper decline in parenting stress related to the child compared to the control group ( d = 0.46). No statistically significant effect on stress related to the parent's own functioning or situation was found. Conclusions The results of the study suggest the feasibility of reducing parenting stress in parents with mild intellectual disability (MID) through parenting support, to the possible benefit of their children. [ABSTRACT FROM AUTHOR]

Objectives To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). Methods A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. Results Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. Conclusion Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended. [ABSTRACT FROM AUTHOR]

Aims To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. Design A parallel-group randomized controlled trial of brief motivational ( n = 185), reduction ( n = 186) or usual care ( n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. Setting United States. Participants A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. Measurements The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. Findings A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Conclusions Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. [ABSTRACT FROM AUTHOR]

Background and purpose Currently, there are limited options for treatment of postherpetic neuralgia ( PHN) patients in China. While pregabalin is an effective treatment option for PHN in several countries, there is limited information on its efficacy in Chinese patients. Methods This was an 8-week, double-blind, placebo-controlled trial in Chinese patients with PHN randomized (1:1) to pregabalin 300 mg/day or placebo. Primary efficacy endpoint was change from baseline in mean pain score (Daily Pain Rating Scale; 0 = 'no pain' to 10 = 'worst possible pain'). Secondary efficacy endpoints included change from baseline in overall pain intensity score, by visual analog scale ( VAS; 0 = 'no pain' to 100 = 'worst possible pain') and daily sleep interference score (0 = 'pain does not interfere with sleep' to 10 = 'completely interferes'). Results A total of 220 patients were randomized and received treatment (111 pregabalin and 109 placebo). Improvement in mean pain score with pregabalin was significantly greater than placebo, least squares mean difference (95% CI), −0.71 (−1.08, −0.34); P = 0.0002. Improvements in VAS and sleep interference score at endpoint were significantly greater with pregabalin than placebo, least squares mean difference (95% CI), −8.18 (−11.99, −4.37); P < 0.0001, and −0.54 (−0.93, −0.14); P = 0.0079, respectively. Adverse events were consistent with current product labeling, with dizziness the most commonly reported adverse event (24.3% of pregabalin-treated patients). Conclusion Pregabalin improved measures of pain and sleep, and is well tolerated in Chinese patients with PHN. These results may inform physicians treating patients with PHN in China. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective To investigate the cost-utility of the internet-based intervention 'Featback' provided with different levels of therapist support, in comparison to a waiting list. Method This economic evaluation was conducted from a societal perspective and was part of a randomized controlled trial in which participants ( N = 354) with self-reported ED symptoms were randomized to: (1) 8 weeks of Featback, consisting of psychoeducation and a fully automated monitoring- and feedback system, (2) Featback with low-intensity (weekly) therapist support, (3) Featback with high-intensity (three times a week) therapist support, and (4) a waiting list. Participants were assessed at baseline, postintervention, and 3-month follow-up. Cost-utility acceptability curves were constructed. Results No significant differences between the study conditions were found regarding quality-adjusted life-years ( P = 0.55) and societal costs ( P = 0.45), although the mean costs per participant were lowest in the Featback condition with low-intensity therapist support (€1951), followed by Featback with high-intensity therapist support (€2032), Featback without therapist support (€2102), and the waiting list (€2582). Featback seemed to be cost-effective as compared to the waiting list. No clear preference was found for Featback with or without therapist support. Discussion A fully automated Internet-based intervention for ED symptoms with no, low-, or high-intensity therapist support represented good value for money when compared to a waiting list. This finding may have important implications for clinical practice, as both the unguided- and guided intervention could allow for more efficient care and widespread dissemination, potentially increasing the accessibility and availability of mental health care services for individuals with ED symptoms. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2016; 49:1068-1076) [ABSTRACT FROM AUTHOR]

Aim The objective of this report was to present histological characteristics and gene expression profile of newly formed bone following horizontal augmentation of the atrophic anterior maxilla using recombinant human bone morphogenetic protein-2 in an absorbable collagen sponge carrier (rh BMP-2/ ACS) versus an autogenous bone graft ( ABG). Methods Bone core biopsies from 24 subjects participating in a randomized clinical trial were obtained at dental implant placement, 6 months following alveolar ridge augmentation using rh BMP-2/ ACS (rh BMP-2 at 1.5 mg/ml; total dose 4.2 mg) or a particulate ABG harvested from the mandibular retro-molar region. A titanium mesh was used to provide wound stability and space for bone formation. Analysis included histological/histometric observations and gene expression profile of the newly formed bone. Results rh BMP-2/ ACS yielded bone marrow rich in capillaries, undifferentiated cells and bone lining cells compared with the ABG ( p = 0.002). Whereas no significant differences were observed in total bone fraction ( p = 0.53), non-vital bone particles trapped in lamellar vital bone were observed in the ABG group ( p < 0.001). Real-time PCR showed greater BMP-2 and RUNX2 expression for rh BMP-2/ ACS over the ABG ( p = 0.001 and 0.0021, respectively), while the ABG exhibited greater expression of RANKL: OPG, BSP and OPN over rh BMP-2/ ACS ( p = 0.01, 0.005 and 0.0009, respectively). Conclusions Our observations suggest that formative biological processes explain bone formation following implantation of rh BMP-2/ ACS, whereas remodelling, resorptive/formative processes, characterizes sites receiving ABGs. [ABSTRACT FROM AUTHOR]

Aim To compare the effectiveness of two-ridge preservation treatments. Materials and Methods Forty subjects with extraction sockets exhibiting substantial buccal dehiscences were enrolled and randomized across 10 standardized centres. Treatments were demineralized allograft plus reconstituted and cross-linked collagen membrane ( DFDBA + RECXC) or deproteinized bovine bone mineral with collagen plus native, bilayer collagen membrane ( DBBMC + NBCM). Socket dimensions were recorded at baseline and 6 months. Wound closure and soft tissue inflammation were followed post-operatively, and biopsies were retrieved for histomorphometric analysis at 6 months. Results Primary endpoint: at 6 months, extraction socket horizontal measures were significantly greater for DBBMC + NBCM (average 1.76 mm greater, p = 0.0256). Secondary and Exploratory endpoints: (1) lingual and buccal vertical bone changes were not significantly different between the two treatment modalities, (2) histomorphometric % new bone and % new bone + graft were not significantly different, but significantly more graft remnants remained for DBBMC; (3) at 1 month, incision line gaps were significantly greater and more incision lines remained open for DFDBA + RECXC; (4) higher inflammation at 1 week tended to correlate with lower ridge preservation results; and (5) deeper socket morphologies with thinner bony walls correlated with better ridge preservation. Thirty-seven of 40 sites had sufficient ridge dimension for implant placement at 6 months; the remainder were DFDBA + RECXC sites. Conclusion DBBMC + NBCM provided better soft tissue healing and ridge preservation for implant placement. Deeper extraction sockets with higher and more intact bony walls responded more favourably to ridge preservation therapy. [ABSTRACT FROM AUTHOR]

The current study examines the efficacy of intensified group therapy for social anxiety disorder with fear of blushing. Task concentration training (TCT) and cognitive therapy (CT) were applied during one weekend and compared with a waiting list condition in a randomized controlled trial including 82 patients. On a second weekend, another intervention was added (resulting in TCT-CT and CT-TCT sequences) to examine order effects. Task concentration training and CT were both superior to the waiting list and equally effective after the first therapy weekend. Also, no differences were found between the sequences TCT-CT and CT-TCT at post-assessment. At 6- and 12-month follow-up, effects remained stable or further improved. At the 6-month follow-up, remission rates in completers, established by diagnostic status, were between 69% and 73%. Intensified group therapy is highly effective in treating social anxiety disorder with fear of blushing. Group formats for patients sharing a common primary concern may contribute to the dissemination of cognitive-behavioural therapy. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message: This study focuses on blushing from fearful individuals within the SAD spectrum to improve evidence for treatment efficacy in those whose social fears are centred around observable bodily sensations., This study integrates task concentration training into the SAD model of Clark and Wells to combine two evidence-based treatments for SAD under one treatment model., This study uses an innovative format of brief, intensified group therapy, conducted on two full-day weekend group sessions delivered over two weekends, with strong observed effect sizes. [ABSTRACT FROM AUTHOR]

Brain-directed treatment techniques, such as neurofeedback, have recently been proposed as adjuncts in the treatment of eating disorders to improve therapeutic outcomes. In line with this recommendation, a cue exposure EEG-neurofeedback protocol was developed. The present study aimed at the evaluation of the specific efficacy of neurofeedback to reduce subjective binge eating in a female subthreshold sample. A total of 75 subjects were randomized to EEG-neurofeedback, mental imagery with a comparable treatment set-up or a waitlist group. At post-treatment, only EEG-neurofeedback led to a reduced frequency of binge eating ( p = .015, g = 0.65). The effects remained stable to a 3-month follow-up. EEG-neurofeedback further showed particular beneficial effects on perceived stress and dietary self-efficacy. Differences in outcomes did not arise from divergent treatment expectations. Because EEG-neurofeedback showed a specific efficacy, it may be a promising brain-directed approach that should be tested as a treatment adjunct in clinical groups with binge eating. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association. [ABSTRACT FROM AUTHOR]

Objective To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. Methods One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified. Results The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects ( P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort ( P = .008) and total population ( P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred. Conclusions In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. identifier: NCT01792817. [ABSTRACT FROM AUTHOR]

Objectives To test a new cognitive behavioral therapy for insomnia ( CBT-I) program designed for use by nonclinicians. Design Randomized controlled trial. Setting Department of Veterans Affairs healthcare system. Participants Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159). Intervention Nonclinician 'sleep coaches' delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education. Measurements Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency ( SOL-D), wake after sleep onset ( WASO-D), total wake time ( TWT-D), and sleep efficiency ( SE-D); Pittsburgh Sleep Quality Index ( PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index ( ISI), depressive symptoms (Patient Health Questionnaire-9 ( PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 ( SF-12v2)). Results Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2. Conclusion Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia. [ABSTRACT FROM AUTHOR]

Objectives To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Design Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Setting Primary care setting, 39 general practices in the Netherlands. Participants Community-dwelling people aged 60 and older (N = 3,092). Interventions A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Measurements Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living ( ADLs), 8 instrumental activities of daily living ( IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. Results The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval ( CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Conclusion Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. [ABSTRACT FROM AUTHOR]

Dialectical behaviour therapy (DBT)-informed skills training for borderline personality disorder (BPD) aims at the development of specific emotion regulation skills in patients, particularly with regard to the regulation of problematic anger. While the effects of dialectical behaviour skills training have been shown, their processes of change are rarely examined. Neacsiu, Rizvi and Linehan (2010) found that patient's self-reported use of emotion regulation skills was a mediator of therapeutic change in these treatments; however, they found no effect for problematic anger. From an integrative perspective on anger (Pascual-Leone & Greenberg, 2007; Pascual-Leone & Paivio, 2013), there are several forms of anger, varying in their degree of therapeutic productivity. The present add-on randomized controlled trial included n = 41 patients with BPD ( n = 21 DBT-informed skills training versus n = 20 treatment as usual). The first study examined the outcome of the DBT-informed skills training encompassing basic components of training in mindfulness, distress tolerance, interpersonal effectiveness and emotion regulation. Results showed that symptom reduction was significantly greater in the DBT-informed skills training, compared with the treatment as usual. The second study used process assessment, for which all patient completers underwent a 50-min-long psychological interview both early and late in treatment, which was rated using the Classification of Affective Meaning States. DBT-informed skills training produced increased levels of primary 'assertive' anger, as compared with the treatment as usual, whereas no effect was found for 'rejecting' secondary anger. Most importantly, we showed that changes in assertive anger mediated the reported symptom reduction, in particular in patient's social roles. We discuss these results in the context of underlying mechanisms of change in DBT skills group treatments, in particular towards developing more productive forms of anger in this patient population. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message A 20-session dialectical behaviour therapy (DBT)-informed skills training is a promising adjunct intervention for patients with borderline personality disorder, in particular for reducing problems related to social role., Increases in assertive anger mediate the effects of DBT-informed skills training, whereas rejecting anger remains unchanged over the course of treatment., Short-term objectives for intervention might involve the specific increase of assertive anger in BPD, by using DBT-informed skills training; long-term objectives for intervention might involve a specific decrease of rejecting anger in BPD. [ABSTRACT FROM AUTHOR]

Objectives To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease ( AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Design Randomized, controlled trial. Setting Community. Participants Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Intervention Two types of intervention comprising customized home-based exercise ( HE) and group-based exercise ( GE), each twice a week for 1 year, were compared with a control group ( CG) receiving usual community care. Measurements Cognitive function was measured using the Clock Drawing Test ( CDT), Verbal Fluency ( VF), Clinical Dementia Rating ( CDR), and Mini-Mental State Examination ( MMSE) at baseline and 3, 6, and 12 months of follow-up. Results Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Conclusion Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. [ABSTRACT FROM AUTHOR]