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Background: Active surveillance (AS) is increasingly used to monitor patients with lower risk prostate cancer (PCa). The Prostate Cancer Active Lifestyle Study (PALS) was a randomized controlled trial to determine whether weight loss improves obesity biomarkers on the causal pathway to progression in patients with PCa on AS. Methods: Overweight/obese men (body mass index >25 kg/m2) diagnosed with PCa who elected AS were recruited. The intervention was a 6‐month, individually delivered, structured diet and exercise program adapted from the Diabetes Prevention Program with a 7% weight loss goal from baseline. Control participants attended one session reviewing the US Dietary and Physical Activity Guidelines. The primary outcome was change in glucose regulation from baseline to the end of the 6‐month intervention, which was measured by fasting plasma glucose, C‐peptide, insulin, insulin‐like growth factor 1, insulin‐like growth factor binding protein‐3, adiponectin, and homeostatic model assessment for insulin resistance. Results: Among 117 men who were randomized, 100 completed the trial. The mean percentage weight loss was 7.1% and 1.8% in the intervention and control arms, respectively (adjusted between‐group mean difference, −6.0 kg; 95% confidence interval, −8.0, −4.0). Mean percentage changes from baseline for insulin, C‐peptide, and homeostatic model assessment for insulin resistance in the intervention arm were −23%, −16%, and −25%, respectively, compared with +6.9%, +7.5%, and +6.4%, respectively, in the control arm (all p for intervention effects ≤.003). No significant between‐arm differences were detected for the other biomarkers. Conclusions: Overweight/obese men with PCa undergoing AS who participated in a lifestyle‐based weight loss intervention successfully met weight loss goals with this reproducible lifestyle intervention and experienced improvements in glucose‐regulation biomarkers associated with PCa progression. The Prostate Cancer Active Lifestyle Study was a randomized controlled trial to determine whether weight loss improves obesity biomarkers on the causal pathway to progression in patients with prostate cancer undergoing active surveillance. Overweight/obese men with prostate cancer on active surveillance who participated in a lifestyle‐based weight loss intervention successfully met weight loss goals and experienced improvements in glucose‐regulation biomarkers associated with prostate cancer progression. [ABSTRACT FROM AUTHOR]

Objective: The objective was to assess the one year implant treatment outcome and patient‐related outcome measures (PROMs) following maxillary sinus floor augmentation (MSFA) with autogenous bone graft (ABG) from the zygomatic buttress (control) compared with 1:1 mixture of ABG and anorganic porcine bone mineral (APBM) (Test I) or biphasic bone graft material (BBGM) (Test II). Materials and Methods: Sixty healthy patients (34 females, 26 males) were randomly allocated to either control or test groups. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of peri‐implant tissue, peri‐implant marginal bone loss, frequency of complications, and PROMs using Oral Health Impact Profile‐14 combined with questionnaire assessing patient perception of peri‐implant soft tissue, prosthetic solution, implant function, and implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was.05. Results: All suprastructures and implants were well‐functioning after one year of functional implant loading. There was no significant difference between control and test groups in any of the applied outcome measures. The implant stability significantly increased from implant placement to abutment connection within all groups (p <.001). High patient satisfaction and significant improvement in oral health‐related quality of life was also reported within all groups. Conclusion: This study demonstrates that MSFA with composite grafts containing minimal amounts of ABG reveals comparable implant treatment outcomes as compared with ABG alone, after one year of functional implant loading. Extensive ABG harvesting in conjunction with MSFA therefore seems not to be needed. [ABSTRACT FROM AUTHOR]

Financial education represents a powerful tool for improving economic literacy of citizens. This paper presents results from an experiment providing a group of 136 workers in an Italian university (administrative staff) an online, synchronous course. Classes were organized in 5 sessions of 2h each and covered basic topics about personal finance. The effectiveness of the course is assessed through a rigorous randomized controlled trial (RCT). In addition to the analysis of improvements in financial knowledge, financial self‐efficacy and the role of prior attitudes and behaviors were explored. Participants obtained post‐test scores statistically higher than individuals in the control group, with an average effect size of 0.55 SD. The effect is particularly relevant for participants starting with low levels of financial knowledge. Moreover, two novel findings emerge: financial self‐efficacy increases (0.51 SD) after the course, and pre‐treatment individuals' financial attitudes and behaviors shed further light on the financial learning process. [ABSTRACT FROM AUTHOR]

Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [ABSTRACT FROM AUTHOR]

Introduction: Childhood cancer survivors (CCS) are at risk of experiencing lower quality-of-life, fatigue, and depression. Few randomized controlled trials have studied the effect of physical activity (PA) on these in adult long-term CCS. This study investigated the effect of a 1-year individualized PA intervention on healthrelated quality-of-life (HRQOL), fatigue, and distress symptoms in adult CCS. Methods: The SURfit trial randomized 151 CCS =16 years old, <16 at diagnosis and =5 years since diagnosis, identified through the Swiss Childhood Cancer Registry. Intervention participants received personalized PA counselling to increase intense PA by =2.5 h/week for 1 year. Controls maintained usual PA levels. The authors assessed physical- and mental-HRQOL, fatigue, and distress symptoms at baseline, 3, 6, and 12 months. T-scores were calculated using representative normative populations (mean = 50, standard deviation = 10). Generalized linear mixed-effects models with intention-to-treat (ITT, primary), and three per-protocol allocations were used. Results: At 12 months, ITT (-3.56 larger decrease, 95% confidence interval -5.69 to -1.43, p = .001) and two per-protocol analyses found significantly lower fatigue. Physical-HRQOL improved significantly in two per-protocol analyses at 12 months. No other effects were found. Conclusion: SURfit showed that increased intense PA over 1 year improved fatigue in adult CCS. Survivors should be recommended PA to reduce the burden of late-effects. [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]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Background: Hand eczema (HE) is a common and heterogeneous condition. It has a wide range of etiologies and clinical manifestations. In this study the efficacy of triamcinolone 0.1% cream and sulfur 2% creams was compared in treating patients with HE. Methods: This randomized, triple‐blind clinical trial was performed on 70 patients with HE (including 70 right and 70 left hands). In this study, two creams were used including triamcinolone 0.1% and sulfur 2.0%. Patients were treated with these creams twice a day (once in every 12 h) for 4 weeks. Follow‐up was 4 weeks after treatment. Hand Eczema Severity Index (HECSI), itching, dryness, burning sensation, and erythema scores were collected three times during the study and compared between treatment regimens. Results: Findings showed that both triamcinolone (0.1%) and sulfur (2.0%) creams could significantly reduce the scores of HECSI, itching, dryness, burning sensation, and erythema, and the therapeutic effects lasted for at least 4 weeks after cessation of topical treatment. Conclusion: Topical sulfur cream (2.0%) is as effective as triamcinolone (0.1%) cream in treatment of HE without any prominent adverse reactions. [ABSTRACT FROM AUTHOR]

Objective: Our ability to predict responsiveness to digital interventions for eating disorders has thus far been poor, potentially for three reasons: (1) there has been a narrow set of predictors explored; (2) prediction has mostly focused on symptom change, ignoring other aspects of the user journey (uptake, early engagement); and (3) there is an excessive focus on the unique effects of predictors rather than the combined contributions of a predictor set. We evaluated the univariate and multivariate effects of outcome predictors in the context of a randomized trial (n = 398) of digitally delivered interventions for recurrent binge eating. Method: Thirty baseline variables were selected as predictors, ranging from specific symptoms, to key protective factors, to technological acceptance, and to online treatment attitudes. Outcomes included uptake, early engagement, and remission. Univariate (d) and multivariate (D) standardized mean differences were calculated to estimate the individual and combined effects of predictors, respectively. Results: At the univariate level, few predictors produced an effect size larger than what is considered small (d >.20) across outcomes. However, our multivariate approach enhanced prediction (Ds =.65 to 1.12), producing accuracy rates greater than chance (63%–71% accuracy). Less than half of the chosen variables proved to be useful in contributing to predictions in multivariate models. Conclusion: Findings suggest that accuracy in outcome prediction from digitally delivered interventions may be better driven by the aggregation of many small effects rather than one or several largely influential predictors. Replication with different data streams (sensor, neuroimaging) would be useful. Public Significance: Our ability to predict who will and will not benefit from digital interventions for eating disorders has been poor. We highlight the viability of a multivariate approach to outcome prediction, whereby prediction may be better driven by the aggregation of many small effects rather than one or a few influential predictors. [ABSTRACT FROM AUTHOR]

To compare the analgesic efficacy and adverse events of proximal versus distal ACB for adults undergoing knee arthroplasty, we searched PubMed, Cochrane, Web of Science, and Embase to identify all eligible randomized controlled trials (RCTs). The study quality of the RCTs was evaluated using the Cochrane risk of bias assessment tool. Heterogeneity among studies was examined by Cochrane Q test. Our primary outcomes were pain intensity at rest/during movement and morphine consumption. Statistical analyses were conducted by RevMan Software. Seven eligible studies involving 400 subjects were included in this meta‐analysis with 202 participants in the proximal ACB group and 198 participants in the distal ACB group. The results demonstrated that proximal ACB provided significantly better pain relief at rest at 2 h (SMD −0.27, 95% CI −0.54 to −0.01, four trials, 222 participants, I2 = 0, p = 0.04) and 24 h (SMD −0.28, 95% CI −0.48 to −0.08, seven trials, 400 participants, I2 = 0, p = 0.006) following the surgery. We found no evidence of a difference in postoperative pain intensity at other timepoints. Furthermore, we noted no evidence of a difference in cumulative morphine consumption and occurrence of adverse events. Proximal ACB provides better pain relief and comparable adverse effects profile compared with distal ACB. The analgesic benefit offered by proximal ACB, however, did not appear to extend beyond the first 24 h. The overall evidence level was mostly low or very low, which requires more well‐organized multicenter randomized trials in the future. [ABSTRACT FROM AUTHOR]

Background: To assess the frequency of patient‐reported outcomes (PROs) and non‐PROs in randomized controlled trials (RCTs) addressing head/neck cancers. Methods: We included RCTs about interventions to treat head/neck cancers. PubMed was searched on September 16, 2022 and included studies published during three periods (2000–2002, 2010–2012, and 2020–2022). Data on types of outcomes and instruments to measure them were extracted and organized into PROs and non‐PROs, and temporal trends for reporting outcomes were determined. Results: There was a reduction in the frequency of non‐PROs (40% to 22%) and an increase in PROs (5% to 19%) over 20 years. The frequency of reporting both non‐PROs and PROs seemed to be stable over the same period (55% to 58%). A great variety of instruments to measure PROs and non‐PROs was identified. Conclusions: There has been a growth in the types of PROs in more recent years, and they were more frequently reported in RCTs. However, head/neck cancer trials with a combination of PROs and non‐PROs were the most prevalent. [ABSTRACT FROM AUTHOR]

Background and purpose: In 2016, we concluded a randomized controlled trial testing 1 mg rasagiline per day add‐on to standard therapy in 252 amyotrophic lateral sclerosis (ALS) patients. This article aims at better characterizing ALS patients who could possibly benefit from rasagiline by reporting new subgroup analysis and genetic data. Methods: We performed further exploratory in‐depth analyses of the study population and investigated the relevance of single nucleotide polymorphisms (SNPs) related to the dopaminergic system. Results: Placebo‐treated patients with very slow disease progression (loss of Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised [ALSFRS‐R] per month before randomization of ≤0.328 points) showed a per se survival probability after 24 months of 0.85 (95% confidence interval = 0.65–0.94). The large group of intermediate to fast progressing ALS patients showed a prolonged survival in the rasagiline group compared to placebo after 6 and 12 months (p = 0.02, p = 0.04), and a reduced decline of ALSFRS‐R after 18 months (p = 0.049). SNP genotypes in the MAOB gene and DRD2 gene did not show clear associations with rasagiline treatment effects. Conclusions: These results underline the need to consider individual disease progression at baseline in future ALS studies. Very slow disease progressors compromise the statistical power of studies with treatment durations of 12–18 months using clinical endpoints. Analysis of MAOB and DRD2 SNPs revealed no clear relationship to any outcome parameter. More insights are expected from future studies elucidating whether patients with DRD2CC genotype (Rs2283265) show a pronounced benefit from treatment with rasagiline, pointing to the opportunities precision medicine could open up for ALS patients in the future. [ABSTRACT FROM AUTHOR]

Summary: Weighted blankets are a non‐pharmacological intervention for treating sleep and anxiety problems in children with attention‐deficit/hyperactivity disorder. However, research on the efficacy of weighted blankets is sparse. The aim of this randomized controlled trial with a crossover design (4 + 4 weeks) was to evaluate the efficacy of weighted blankets on sleep among children with attention‐deficit/hyperactivity disorder and sleeping problems. Children diagnosed with uncomplicated Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition attention‐deficit/hyperactivity disorder with verified sleep problems were randomized to start with either a weighted blanket or a lighter control blanket. Data collection was performed at weeks 0, 4 and 8 using actigraphy, questionnaires and a daily sleep diary. T‐tests were used to evaluate efficacy. The study included 94 children with attention‐deficit/hyperactivity disorder (mean age 9.0 [sd 2.2] years; 54 [57.4%] boys). Weighted blankets had a significant effect on total sleep time (mean diff. 7.72 min, p = 0.027, Cohen's d = 0.24), sleep efficiency (mean diff. 0.82%, p = 0.038, Cohen's d = 0.23) and wake after sleep onset (mean diff. −2.79 min, p = 0.015, Cohen's d = −0.27), but not on sleep‐onset latency (p = 0.432). According to our exploratory subgroup analyses, weighted blankets may be especially beneficial for improving total sleep time in children aged 11–14 years (Cohen's d = 0.53, p = 0.009) and in children with the inattentive attention‐deficit/hyperactivity disorder subtype (Cohen's d = 0.58, p = 0.016). Our results suggest that weighted blankets may improve children's sleep and could be used as an alternative to pharmacological sleep interventions. [ABSTRACT FROM AUTHOR]

Introduction: Treatment of pregnancy‐associated breast cancer is complex, as providers try to balance risks to the pregnant person and the developing fetus. Given increased case fatality and increasing incidence, there is a pressing need understand the efficacy and safety of different treatment regimens in this population; however, pregnant and lactating people have traditionally been excluded from participating in randomized controlled trials (RCTs). Given recent efforts to expand the inclusion criteria for oncology RCTs, this study aimed to review the inclusion/exclusion criteria of current breast cancer RCTs to assess what proportion of trials permitted enrollment of pregnant and lactating persons. Material and methods: We conducted a comprehensive search of ClinicalTrials.gov in January 2022 to identify interventional studies of breast cancer in adults that were actively recruiting. The primary outcomes were the exclusion of pregnant and lactating people. Results: The search identified 1706 studies, of which 1451 met eligibility criteria. Overall, 69.4% and 54.8% of studies excluded pregnant and lactating people, respectively. The exclusion of pregnant and lactating persons differed by study characteristics but extended across all trial designs, locations, phases and interventions. Exclusion of pregnant and lactating persons was most common in trials where the intervention was biological (86.3%), drug (83.5%) or radiation (81.5%). Conclusions: The exclusion of pregnant and lactating people from clinical trials contributes to evidence gaps in how to treat this population. A paradigm shift is needed that focuses on how research can be used to protect pregnant people from future harms, instead of protecting pregnant people from research‐related risks. [ABSTRACT FROM AUTHOR]

Aim: This study investigated the impact of an 8‐month daily‐guided intensive meditation‐based intervention (iMI) on persistent hallucinations/delusions and health‐related quality of life (QoL) in male inpatients with schizophrenia with treatment‐refractory hallucinations and delusions (TRHDs). Methods: A randomized controlled trial assigned 64 male inpatients with schizophrenia and TRHD equally to an 8‐month iMI plus general rehabilitation program (GRP) or GRP alone. Assessments were conducted at baseline and the third and eighth months using the Positive and Negative Syndrome Scale (PANSS), 36‐Item Short Form‐36 (SF‐36), and Five Facet Mindfulness Questionnaire (FFMQ). Primary outcomes measured PANSS reduction rates for total score, positive symptoms, and hallucinations/delusions items. Secondary outcomes assessed PANSS, SF‐36, and FFMQ scores for psychotic symptoms, health‐related QoL, and mindfulness skills, respectively. Results: In the primary outcome, iMI significantly improved the reduction rates of PANSS total score, positive symptoms, and hallucination/delusion items compared with GRP at both the third and eighth months. Treatment response rates (≥25% reduction) for these measures significantly increased in the iMI group at the eighth month. Concerning secondary outcomes, iMI significantly reduced PANSS total score and hallucination/delusion items, while increasing scores in physical activity and mindfulness skills at both the third and eighth months compared with GRP. These effects were more pronounced with an 8‐month intervention compared with a 3‐month intervention. Conclusions: An iMI benefits patients with TRHDs by reducing persistent hallucinations/delusions and enhancing health‐related QoL. Longer iMI duration yields superior treatment outcomes. [ABSTRACT FROM AUTHOR]

Objective: Although inpatient treatment is highly effective for patients with bulimia nervosa (BN), some patients show a resurgence of symptoms and relapse after discharge. Therefore, the aim of this study is to evaluate the efficacy of a guided smartphone‐based aftercare intervention following inpatient treatment to support recovery. Method: 172 female patients with BN (DSM‐5: 307.51) will be randomized to receive a 16‐week smartphone‐based aftercare intervention (German version of 'Recovery Record') with therapist feedback as an add‐on element to treatment as usual (TAU) or TAU alone. Assessments will take place at baseline (discharge, T0), during the intervention (after 4 weeks, T1), post‐intervention (after 16 weeks, T2) and at 6‐month follow‐up (T3). Primary outcome will be remission at T2. Moderator and mediator analyses will investigate for whom the aftercare intervention suits best and how it works. Conclusions: This is the first randomized controlled trial to examine a guided smartphone‐based aftercare intervention following inpatient treatment of patients with BN. We expect that this innovative aftercare intervention is highly accepted by the patients and that it has the potential to support recovery after inpatient treatment and thereby could contribute to improving aftercare for patients with BN. Highlights: There are several studies reporting relapse rates for patients with bulimia nervosa (BN) after having received remission or abstinence at the end of treatment.This is the first randomized controlled trial (RCT) to investigate the effects of a guided smartphone‐based aftercare following inpatient treatment of patients with BN.If this innovative aftercare intervention is accepted by the patients and supports recovery after inpatient treatment for patients with BN, it could contribute to improving aftercare for patients with BN. [ABSTRACT FROM AUTHOR]

External validity is an important parameter that needs to be considered for decision making in health research, but no widely accepted measurement tool for the assessment of external validity of randomized controlled trials (RCTs) exists. One of the most limiting factors for creating such a tool is probably the substantial heterogeneity and lack of consensus in this field. The objective of this study was to reach consensus on a definition of external validity and on criteria to assess the external validity of RCTs included in systematic reviews. A three‐round online Delphi study was conducted. The development of the Delphi survey was based on findings from a previous systematic review. Potential panelists were identified through a comprehensive web search. Consensus was reached when at least 67% of the panelists agreed to a proposal. Eighty‐four panelists from different countries and various disciplines participated in at least one round of this study. Consensus was reached on the definition of external validity ("External validity is the extent to which results of trials provide an acceptable basis for generalization to other circumstances such as variations in populations, settings, interventions, outcomes, or other relevant contextual factors"), and on 14 criteria to assess the external validity of RCTs in systematic reviews. The results of this Delphi study provide a consensus‐based reference standard for future tool development. Future research should focus on adapting, pilot testing, and validating these criteria to develop measurement tools for the assessment of external validity. [ABSTRACT FROM AUTHOR]

The Mediterranean diet (MD) is one of the healthiest and most sustainable food regimes. Nevertheless, MD diffusion is still limited, emphasizing the need to understand the psychosocial factors that could predict and promote its adoption. Starting from an integrated model of Theory of Planned Behavior (TPB) and Self‐Determination Theory (SDT), the present randomized controlled trial investigated the effect of manipulating motivation (autonomous vs. controlled) on intention and MD adherence behavior. Participants included 726 Italian adults randomly allocated to one of three conditions: autonomous motivation manipulation, controlled motivation manipulation, and control group. TPB variables were measured immediately after manipulation (T1), while MD adherence was evaluated 2 weeks later (T2). Results from multivariate analyses of variance highlighted that participants in the autonomous motivation condition reported higher intention and a more favorable cognitive attitude than control group participants. However, no change in behavior was found. Moreover, a path analysis with mediation effect showed that the impact of autonomous motivation condition versus control group on intention was mediated by cognitive attitude. Findings support the integration of TPB and SDT to encourage intention to adhere to the MD, also suggesting that prompting autonomous motivation may help to promote a greater diffusion of this healthy and sustainable dietary pattern. [ABSTRACT FROM AUTHOR]

Background: Under the guidance of a preliminary Live with Love Conceptual Framework, a Caring for Couples Coping with Colorectal Cancer (4Cs: CRC) programme was designed specifically for colorectal cancer couples. The objectives of this study included examining the efficacy of the programme for couples adapting to colorectal cancer and comparing the effects of different intervention delivery modes (online, face‐to‐face and blended) on couple outcomes. Methods: A four‐arm randomized controlled trial was conducted among Chinese colorectal cancer couples. Couples were randomly assigned to an online intervention, a face‐to‐face intervention, a blended intervention or a control group. Self‐efficacy, dyadic coping, communication and dyadic outcomes (physical and mental health, negative and positive emotions and marital satisfaction) were evaluated at baseline and 6 weeks later. Analysis of variance (ANOVA) and repeated measures ANOVA were employed to assess between‐group differences and within‐group effects in the four groups, respectively. Results: A total of 179 couples completed the 6‐week study and post‐study assessments. The intervention showed generally medium‐to‐large effects across multiple measured outcomes, including self‐efficacy, dyadic coping, communication, mental health, negative emotions and positive emotions for both patients and spouse caregivers. Additionally, interventions delivered through different modes produced equally significant effects on couple outcomes. Conclusions: The integrated intervention programme is effective in improving cancer adaptation in colorectal cancer couples. Long‐term follow‐up and a mix of quantitative and qualitative assessments are crucial for further evaluation of the programme. Trial registration: Retroactive registration is under review. [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]

Background and aims: Controlled drinking (CD) is an attractive treatment goal for a large proportion of individuals with alcohol use disorder (AUD), but the availability of treatment methods supporting a goal of CD is scarce. We tested if behavioural self‐control training (BSCT) was superior to motivational enhancement therapy (MET) for individuals with AUD with a treatment goal of CD. Design: Randomized controlled two‐group trial. Follow‐ups were conducted at 12 and 26 weeks (primary end‐point) after inclusion. Setting: Three specialized dependency care clinics in Stockholm, Sweden. Participants: Two hundred and fifty self‐referred adults (52% men) fulfilling criteria of AUD (DSM‐5) and a stated treatment goal of CD. Intervention and comparator: BSCT (n = 125), a five‐session treatment based on cognitive behavioural therapy versus the active comparator, MET (n = 125), containing four sessions based on Motivational Interviewing. Measurements Primary outcome measure was mean weekly alcohol consumption at the 26‐week follow‐up, adjusted for baseline consumption. Conclusions: A randomized controlled trial found no evidence of a difference between behavioural self‐control training and motivational enhancement therapy in reducing weekly alcohol consumption. Both groups substantially reduced consumption and behavioural self‐control training was superior in reducing hazardous drinking. [ABSTRACT FROM AUTHOR]

The authors investigate the effects of centering meditation on state hope among college and graduate students through a randomized controlled trial. Participants (n = 150; 65% white, 84% female) were randomized to either a centering meditation group or a waitlist control group. Time‐series analyses indicated that centering meditation significantly improved hope, suggesting long‐term dynamic adjustment, compared to a control group. Specifically, the autoregressive integrated moving average (ARIMA) procedures indicated that the treatment group exhibited a statistically significant upward trend in hope, ARIMA (1, 1, 0). As expected, the control group's levels of hope were stationary, ARIMA (1, 0, 1). The study highlights the potential benefits of centering meditation as an evidence‐based counseling intervention for improving hope in the college population. [ABSTRACT FROM AUTHOR]

Introduction: Unhealthy alcohol use significantly contributes to viral non‐suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub‐Saharan Africa (SSA). Methods: As part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills‐based alcohol intervention among PWH with self‐reported unhealthy alcohol use (Alcohol Use Disorders Identification Test–Consumption [AUDIT‐C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non‐suppression, defined as either recent HIV viral non‐suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3‐month in‐person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (<400 copies/ml) at 24 weeks, and the secondary outcome was unhealthy alcohol use, defined by AUDIT‐C or phosphatidylethanol (PEth), an alcohol biomarker, ≥50 ng/ml at 24 weeks. Results: Between April and September 2021, 401 persons (198 intervention, 203 control) were enrolled from HIV clinics in Uganda (58%) and Kenya (27%) and alcohol‐serving venues in Kenya (15%). At baseline, 60% were virally suppressed. Viral suppression did not differ between arms at 24 weeks: suppression was 83% in intervention and 82% in control arms (RR: 1.01, 95% CI: 0.93–1.1). Among PWH with baseline viral non‐suppression, 24‐week suppression was 73% in intervention and 64% in control arms (RR 1.15, 95% CI: 0.93–1.43). Unhealthy alcohol use declined from 98% at baseline to 73% in intervention and 84% in control arms at 24 weeks (RR: 0.86, 95% CI: 0.79–0.94). Effects on unhealthy alcohol use were stronger among women (RR 0.70, 95% CI: 0.56–0.88) than men (RR 0.93, 95% CI: 0.85–1.01) and among participants with a baseline PEth⩽200 ng/ml (RR 0.68, 95% CI: 0.53–0.87) versus >200 ng/ml (RR 0.97, 95% CI: 0.92–1.02). Conclusions: In a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non‐suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV‐associated co‐morbidities. [ABSTRACT FROM AUTHOR]

Background: Alcohol use and its related consequences are a public health problem among young adults. Building upon efficacious personalized normative feedback interventions, dynamic norms can be used to highlight the decreasing prevalence of alcohol use over time among young adults' peers, thereby increasing their motivation to change drinking consistent with the trend. Because limited research has examined dynamic norms feedback interventions for alcohol use, we examined the acceptability and initial efficacy of such an intervention, and potential iatrogenic effects of showing norms feedback about drinking to light drinkers and nondrinkers. Methods: Participants were 546 unvaccinated young adults ages 18–24 who completed a baseline survey, intervention, and 1‐month follow‐up assessment. Participants were block randomized to receive a brief web‐based dynamic norms intervention, with feedback content focused on either (a) alcohol‐related behaviors (intervention) or (b) COVID‐19 vaccine behaviors (the attention‐matched control for the present study). Results: On average, participants who received the alcohol intervention rated it as generally engaging, helpful, and acceptable, with the majority (90.8%) indicating that they would recommend it to a friend. Supporting initial efficacy, in generalized linear models controlling for demographics and baseline alcohol outcomes, at 1‐month follow‐up the alcohol intervention was associated with statistically and clinically significant reductions in all indices of perceived drinking norms, drinking quantity, drinking frequency, and driving after drinking occasions. Lighter drinkers showed no adverse iatrogenic effects. Conclusions: Presenting alcohol‐related personalized normative feedback using dynamic trends is a promising intervention for reducing alcohol use in a community sample of young adults. Further research clarifying the optimal presentation of dynamic norms is needed. [ABSTRACT FROM AUTHOR]

Background and Aims: There is little RCT evidence that brief interventions improve treatment seeking in individuals with severe alcohol use disorder (AUD) or treatment seeking reduces alcohol use. The aim was to test the efficacy of a brief intervention to increase treatment seeking in treatment naïve adults with severe AUD and measure its effects on alcohol use. Design: Parallel group, non‐pharmacologic RCT with intervention (n = 197) and active control (n = 203) conditions, with blinded assessors conducting follow‐ups at 1, 3 and 6 months. Setting: Online recruitment in a 17‐county region of upstate New York, USA. Participants: Inclusion criteria consisted of ages ≥18 years, Alcohol Use Disorders Identification Test score ≥16, exceeds recommended limits for alcohol use and no history of AUD treatment. n = 400; 50% female; 79% white; mean age, 40.7; mean education, 14.6 years. Intervention and comparator: One‐session telephone‐delivered interventions: Cognitive‐Behavioral Therapy for Treatment Seeking (CBT‐TS; intervention), review of a National Institute on Alcohol Abuse and Alcoholism pamphlet on AUD treatment (control). Measurements Self‐report of any AUD treatment use over 3 months (primary outcome) and two standard measures of alcohol use over 6 months (secondary outcomes). Findings Intent‐to‐treat analyses were used. Assessment follow‐up rates were ≥93%. Any alcohol‐related treatment use over 3‐month follow‐up was obtained by 38 (19%) intervention participants and 36 (18%) control participants, a non‐significant difference, χ2 [1] = 0.16, P = 0.689. Secondary analysis showed a significant interaction term between sex and intervention assignment (β = −1.197, P = 0.027). The interaction suggested CBT‐TS was effective in men (22% vs 13%), although the evidence was somewhat weak (P = 0.071), and it was not effective in women (17% vs 24%). Conclusions: A one‐session cognitive‐behavioral therapy intervention to increase treatment seeking in treatment naïve adults with severe alcohol use disorder did not increase treatment seeking. [ABSTRACT FROM AUTHOR]

Objective: The aim was to evaluate the 1‐year implant outcome and patient‐related outcome measures (PROMs) after maxillary sinus membrane elevation and coagulum (test) compared with maxillary sinus floor augmentation and a 1:1 ratio of autogenous bone graft from the buccal antrostomy and deproteinised porcine bone mineral (DPBM) (control). Materials and methods: Forty patients (30 female, 10 male) with a mean age of 50 years (range 25–71 years) and an alveolar ridge height between 4 and 7 mm were randomly allocated to test or control. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of the peri‐implant tissue, peri‐implant marginal bone loss, frequency of complications and PROMs using Oral Health Impact Profile‐14 combined with questionnaires assessing patient's perception of the peri‐implant soft tissue, implant crown, function of the implant, and total implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was 0.05. Results: All suprastructures and implants were well‐functioning after 1‐year of functional implant loading. No significant difference in any of the applied outcome measures was observed between test and control. Both treatments revealed high patient satisfaction scores and significant improvement in oral health‐related quality of life. Conclusion: There were no significant differences in implant outcome and PROMs between test and control, after 1‐year of functional implant loading. Neither of the treatments can therefore be considered better than the other. Thus, long‐term randomized controlled trials are needed before definitive conclusions can be provided about the two treatment modalities. [ABSTRACT FROM AUTHOR]

Background: Although most patients with cancer are treated with local therapy (LT), the proportion of late‐phase clinical trials investigating local therapeutic interventions is unknown. The purpose of this study was to determine the proportion, characteristics, and trends of phase 3 cancer clinical trials assessing the therapeutic value of LT over time. Methods: This was a cross‐sectional analysis of interventional randomized controlled trials in oncology published from 2002 through 2020 and registered on ClinicalTrials.gov. Trends and characteristics of LT trials were compared to all other trials. Results: Of 1877 trials screened, 794 trials enrolling 584,347 patients met inclusion criteria. A total of 27 trials (3%) included a primary randomization assessing LT compared with 767 trials (97%) investigating systemic therapy or supportive care. Annual increase in the number of LT trials (slope [m] = 0.28; 95% confidence interval [CI], 0.15–0.39; p <.001) was outpaced by the increase of trials testing systemic therapy or supportive care (m = 7.57; 95% CI, 6.03–9.11; p <.001). LT trials were more often sponsored by cooperative groups (22 of 27 [81%] vs. 211 of 767 [28%]; p <.001) and less often sponsored by industry (5 of 27 [19%] vs. 609 of 767 [79%]; p <.001). LT trials were more likely to use overall survival as primary end point compared to other trials (13 of 27 [48%] vs. 199 of 767 [26%]; p =.01). Conclusions: In contemporary late‐phase oncology research, LT trials are increasingly under‐represented, under‐funded, and evaluate more challenging end points compared to other modalities. These findings strongly argue for greater resource allocation and funding mechanisms for LT clinical trials. Plain language summary: Most people who have cancer receive treatments directed at the site of their cancer, such as surgery or radiation.We do not know, however, how many trials test surgery or radiation compared to drug treatments (that go all over the body).We reviewed trials testing the most researched strategies (phase 3) completed between 2002 and 2020.Only 27 trials tested local treatments like surgery or radiation compared to 767 trials testing other treatments.Our study has important implications for funding research and understanding cancer research priorities. In this comprehensive study, the authors aimed to evaluate the representation of LT in 794 phase 3 randomized trials registered on ClinicalTrials.gov and published between 2002 and 2020. Study results showed that only 27 trials (3.4%) tested LT, compared with 767 trials (96.6%) that investigated other modalities such as systemic therapy or supportive care. [ABSTRACT FROM AUTHOR]

The current study aimed to examine the effects of a conversation map (CM) psychosocial intervention on diet and exercise health beliefs and health behaviors among people with diabetes (PWD). Based on the Health Belief Model, this large‐scale randomized controlled trial (N = 615) investigated whether an added 1‐h theory‐driven CM intervention (N = 308), compared with usual shared‐care service only (N = 307), could significantly better improve PWD's diet and exercise health beliefs and health behaviors at 3‐month posttest. Multivariate linear autoregression analysis demonstrated that, controlling for baseline, the CM group had significantly better diet (β =.270) and exercise (β =.280) health behaviors at 3‐month posttest than the control group. The intervention effects on health behavior change were primarily mediated through desired changes in targeted health beliefs, as informed by the theory. For example, as regards diet, the CM group had significantly greater increases in perceived susceptibility (β =.121), perceived benefits (β =.174), and cues to action (β =.268), as well as greater decreases in perceived barriers (β = −.156), between pretest and 3‐month posttest. In conclusion, future diabetes care may integrate brief theory‐driven CM interventions, as in this study, into current shared‐care practice to help PWD improve diabetes self‐management health behaviors more effectively. Implications for practice, policy, theory, and research are discussed. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether use of ST analysis of the fetal electrocardiogram (STan) as an adjunct to continuous cardiotocography (CTG) reduces the rate of emergency Cesarean section (EmCS) compared with CTG alone. Methods: This was a randomized controlled trial of patients with a singleton fetus in cephalic presentation at ≥ 36 weeks' gestation, requiring continuous electronic fetal monitoring during labor at a tertiary maternity hospital in Adelaide, Australia, between January 2018 and July 2021. Participants were randomized to undergo CTG + STan or CTG alone. The calculated sample size was 1818 participants. The primary outcome was EmCS. Secondary outcomes included metabolic acidosis, a composite adverse perinatal outcome, and other maternal and neonatal morbidity and safety outcomes. Results: The present study enrolled 970 women, of whom 967 were included in the primary analysis. EmCS occurred in 107/482 (22.2%) deliveries in the CTG + STan arm and in 107/485 (22.1%) in the CTG arm (adjusted relative risk, 1.02 (95% CI, 0.81–1.27); P = 0.89). There was no difference in the rate of adverse maternal or neonatal outcomes between arms. Conclusions: The addition of STan as an adjunct to continuous CTG did not reduce the EmCS rate. The smaller‐than‐anticipated sample size meant that this study was underpowered to detect absolute differences of ≤ 5% and, therefore, this negative finding could be due to a Type‐2 error. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to evaluate the peri‐implant soft tissue and marginal bone loss (MBL) around implants with platform‐switching and internal conical connection placed at crestal and subcrestal levels in posterior areas. Materials and methods: Nineteen partially edentulous patients with at least two adjacent missing teeth in posterior areas unilaterally or bilaterally were included. Forty‐two implants were placed randomly at the crestal or subcrestal (1 mm) level in a split‐mouth design. Implant‐supported fixed dental prostheses with screw retention were delivered after 4 months of healing. Clinical and radiological measurements were performed at implant placement (T0), restoration delivery (T1), and 1‐year follow‐up after loading (T2). MBL was calculated as the change in distance from the implant‐abutment interface to the first radiographically visible bone‐implant contact. A repeated‐measures mixed ANOVA followed by a paired Student's t‐test with the Bonferroni correction was used for statistical analysis. p < 0.05 was considered statistically significant. Results: Eighteen patients with thirty‐eight implants completed the study at T2. The MBL was lower in the subcrestal group than in the crestal group (0.04 ± 0.08 vs. 0.17 ± 0.17 mm, p = 0.004). The peri‐implant probing depth (PD) was 2.31 ± 0.48 mm in the subcrestal group and 1.92 ± 0.43 mm in the crestal group; this difference was statistically significant (p = 0.002). Intragroup comparison showed no significant differences in MBL, or PD around the crestal group and subcrestal group from T1 to T2. Conclusion: After 1 year of functional loading, subcrestal placement of implants with platform‐switching and internal conical connection showed lower MBL and was associated with greater PD and peri‐implant soft tissue height than implants placed at the crestal level. [ABSTRACT FROM AUTHOR]

Background: Montelukast is a highly selective and specific cysteinyl leukotriene receptor antagonist used in the treatment of asthma. Whether montelukast as adjuvant therapy can significantly and safely treat adults with cough variant asthma (CVA) remains inconclusive. Aims: This meta‐analysis systematically evaluated the efficacy and safety of montelukast as an adjuvant treatment for adults with CVA. Materials and methods: Randomized controlled trials (RCTs) on montelukast combined with inhaled corticosteroids (ICS) and long‐acting β2 agonists (LABAs) to treat CVA in adults, from inception to March 6, 2023, were retrieved from the CNKI, Wanfang, VIP, CBM, PubMed, Embase, Cochrane Library, and Web of Science databases and Clinical Trials website. Review Manager (version 5.4) and Stata (version 15.0) were used to conduct the meta‐analysis. Results: A total of 15 RCTs were ultimately included in the meta‐analysis. It was established that montelukast as adjuvant therapy raised the total effective rate (RR = 1.20, 95% confidence interval [CI] [1.13, 1.27], P < 0.01) and improved the FEV1% (SMD = 0.91, 95% CI [0.40, 1.41], P < 0.01), PEF% (SMD = 0.63, 95% CI [0.38, 0.88], P < 0.01), FEV1 (SMD = 1.15, 95% CI [0.53, 1.77], P < 0.01), PEF (SMD = 0.64, 95% CI [0.42, 0.86], P < 0.01), and FEV1/FVC% (SMD = 0.76, 95% CI [0.51, 1.01], P < 0.01) and reduced the recurrence rate (RR = 0.28, 95% CI [0.15, 0.53], P < 0.01). The incidence of adverse reactions was higher in the montelukast auxiliary group compared to the control group but with no statistical difference (RR = 1.32, 95% CI [0.89, 1.96], P = 0.17). Conclusion: Existing evidence indicated that the use of montelukast as an adjuvant therapy had therapeutic efficacy superior to ICS + LABA alone for the treatment of adult patients with CVA. However, further research is needed, especially a combination of high‐quality long‐term prospective studies and carefully designed RCTs. [ABSTRACT FROM AUTHOR]

Objective: To optimize treatment recommendations for eating disorders, it is important to investigate whether some individuals may benefit more (or less) from certain treatments. The current study explored predictors and moderators of an automated online self‐help intervention "Featback" and online support from a recovered expert patient. Methods: Data were used from a randomized controlled trial. For a period of 8 weeks, participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, (2) chat or e‐mail support from an expert patient, (3) Featback with expert‐patient support, and (4) a waitlist. A mixed‐effects partitioning method was used to see if age, educational level, BMI, motivation to change, treatment history, duration of eating disorder, number of binge eating episodes in the past month, eating disorder pathology, self‐efficacy, anxiety and depression, social support, or self‐esteem predicted or moderated intervention outcomes in terms of eating disorder symptoms (primary outcome), and symptoms of anxiety and depression (secondary outcome). Results: Higher baseline social support predicted less eating disorder symptoms 8 weeks later, regardless of condition. No variables emerged as moderator for eating disorder symptoms. Participants in the three active conditions who had not received previous eating disorder treatment, experienced larger reductions in anxiety and depression symptoms. Discussion: The investigated online low‐threshold interventions were especially beneficial for treatment‐naïve individuals, but only in terms of secondary outcomes, making them well‐suited for early intervention. The study results also highlight the importance of a supportive environment for individuals with eating disorder symptoms. Public Significance: To optimize treatment recommendations it is important to investigate what works for whom. For an internet‐based intervention for eating disorders developed in the Netherlands, individuals who had never received eating disorder treatment seemed to benefit more from the intervention than those who had received eating disorder treatment, because they experienced larger reductions in symptoms of depression and anxiety. Stronger feelings of social support were related to less eating disorder symptoms in the future. [ABSTRACT FROM AUTHOR]

Aims: Misoprostol is a prostaglandin E1 analogue that is used to prevent nonsteroidal anti‐inflammatory drug (NSAID)‐induced gastrointestinal disorders. The aim of this systematic review and meta‐analysis was to evaluate whether use of misoprostol also decreases the risk of NSAID‐induced kidney injury. Methods: Randomized controlled trials that compared misoprostol vs. placebo in an adult patient population were selected. The primary outcome was kidney injury and the secondary outcome was severe adverse events. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Twelve studies were eligible for inclusion. Although the rates of kidney injury and severe adverse events did not differ significantly between misoprostol and placebo, a posthoc subgroup analysis that excluded studies in which different NSAIDs were used in the misoprostol and placebo groups suggested that misoprostol may reduce the risk of NSAID‐induced kidney injury (risk difference −0.09, 95% confidence interval −0.15 to −0.03, P <.01, I2 = 87%; evidence of very low certainty). Conclusion: There is limited evidence that misoprostol reduces the risk of NSAID‐induced kidney injury. Misoprostol possibly contributes to reducing the risk of kidney injury associated with chronic NSAID use. The findings of this meta‐analysis suggest further high‐quality clinical trials are warranted. [ABSTRACT FROM AUTHOR]

Objective: This pragmatic randomized control trial aimed to evaluate clinical efficacy of the Making Sense of Brain Tumour program delivered via videoconferencing (Tele‐MAST) for improving mental health and quality of life (QoL) relative to standard care in individuals with primary brain tumor (PBT). Method: Adults with PBT experiencing at least mild distress (Distress Thermometer ≥4) and caregivers were randomly allocated to the 10‐session Tele‐MAST program or standard care. Mental health and QoL were assessed pre‐intervention, post‐intervention (primary endpoint), and 6‐weeks and 6‐months follow‐up. The primary outcome was clinician‐rated depressive symptoms on the Montgomery‐Asberg Depression Rating Scale. Results: 82 participants with PBT (34% benign, 20% lower‐grade glioma, 46% high‐grade glioma) and 36 caregivers were recruited (2018–2021). Controlling for baseline functioning, Tele‐MAST participants with PBT had lower depressive symptoms at post‐intervention (95% CI: 10.2–14.6, vs. 15.2–19.6, p = 0.002) and 6‐weeks post‐intervention (95% CI: 11.5–15.8 vs. 15.6–19.9, p = 0.010) than standard care, and were almost 4 times more likely to experience clinically reduced depression (OR, 3.89; 95% CI: 1.5–9.9). Tele‐MAST participants with PBT also reported significantly better global QoL, emotional QoL and lower anxiety at post‐intervention and 6‐weeks post‐intervention than standard care. There were no significant intervention effects for caregivers. At 6‐months follow‐up participants with PBT who received Tele‐MAST reported significantly better mental health and QoL relative to pre‐intervention. Conclusions: Tele‐MAST was found to be more effective for reducing depressive symptoms at post‐intervention than standard care for people with PBT but not caregivers. Tailored and extended psychological support may be beneficial for people with PBT. [ABSTRACT FROM AUTHOR]

Enhanced Academic Support (EAS) is an intervention designed to improve academic achievement among children who receive support from the child welfare services (CWSs) in the home. We investigated the effects of EAS in a randomized controlled trial in Norway. In total, 82 families who received support from the CWS were included in the study (37 in the intervention group, 45 in the comparison group). Both groups were invited to a pretest, posttest, and follow‐up measure of the children's math and reading skills, their teachers' evaluation of their academic competence, and of parental involvement in children's education. CWS workers, parents, and children reported the dosage of academic support received. In the intervention group, 48% of families received the threshold dosage of EAS needed for the intervention to be considered as delivered. There were no statistically significant differences between the intervention and comparison group on the children's math and reading skills, or their teachers' evaluation of the children's academic competence. Given the variation in intervention delivery and the limited statistical power, limited conclusions about the effect of EAS can be made. Important lessons from implementation in CWS and on conducting a pragmatic randomized trial are discussed. Practitioner Points: We investigated the effects of Enhanced Academic Support in a randomized controlled trialThere were no differences between the intervention and comparison group on the children's math and reading skills, or their academic competenceThe lack of effects may be due to variation in intervention delivery and the limited statistical power, and important lessons from the trial are discussed [ABSTRACT FROM AUTHOR]

Introduction: Children born to mothers with gestational diabetes mellitus (GDM) are at risk of metabolic disturbances such as diabetes mellitus and overweight. However, few have examined the outcome of children whose mothers were at risk of GDM. The aim of the study was to investigate how mothers' risk of developing GDM affects physical health and neurodevelopment of the children at 7 years of age. Material and methods: This is a secondary analysis of a follow‐up study of a multicenter randomized controlled trial including 855 pregnant women, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital in Norway from 2007 to 2009. Risk factors for developing GDM included age >40 years, diabetes in near family, previous child with birthweight ≥4500 g and pre‐pregnancy body mass index (BMI) ≥25 kg/m2. Data on GDM risk factors were available for 750 women, who were divided into a risk group if they had one or more risk factors for developing GDM (n = 238) and a no risk (n = 512) group. At 7 years of age, 72 children born to mothers in the risk group and 194 children born to mothers in the no risk group participated. The children's height, weight and physical activity were reported by their parents. Neurodevelopmental outcomes were assessed by using the Five‐to‐Fifteen questionnaire, which includes motor skills, executive functions, perception, memory, language, social skills, and emotional/behavioral problems. Results: Most women had only one risk factor for GDM, and pre‐pregnancy overweight was the most prevalent risk factor. Children of mothers in the risk group had higher birthweight and length. At the 7‐year follow‐up, they had a higher weight and BMI, and the odds ratio of being overweight was 3.0 (95% confidence interval 1.1–8.3). There was no group difference in the children's physical activity and their neurodevelopmental outcomes were similar. Conclusions: We found higher BMI and increased risk of overweight in children born to mothers with one or more risk factors for developing GDM. A focus on preventing pre‐pregnancy overweight should be encouraged. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Background: Despite extensive efforts and advances in developing and fostering evidence‐based delirium prevention interventions, the incidence of delirium remains high in hospitalized patients. Evidence suggests that sensory stimulation is a core component in interventions to prevent delirium among critically ill patients. However, its impact on the occurrence and outcomes of delirium is poorly understood. Aim: To evaluate the effects of a sensory stimulation intervention on preventing delirium in a surgical intensive care unit (ICU). Study Design: A prospective, assessor‐blind, parallel‐group randomized controlled trial. Adult patients were recruited from a surgical ICU of one tertiary hospital in Guangzhou, China. Participants in the intervention group received a daily 30‐min auditory and visual stimulation session for a week, taking into consideration the participants' predefined condition and intervention protocol. The primary outcomes were delirium incidence and delirium‐free days, and the secondary outcomes were delirium duration, severity and the first occurrence of delirium. Demographic and clinical data were collected at recruitment, and delirium was assessed three times a day for seven consecutive days using Confusion Assessment‐ICU. Results: One hundred and fifty‐two participants were randomly assigned to intervention or control groups. For primary outcomes, there were fewer patients with delirium in the intervention group than in the control group (10 vs. 19, risk ratio = 0.53), although statistical significance was not reached. The result showed that there were longer delirium‐free days among participants in the intervention group than in the control group (3.66 vs. 2.84, p =.019). For secondary outcomes, the intervention could significantly reduce delirium duration (1.70 ± 0.82 vs. 4.53 ± 2.74 days, p =.004) and delirium severity (3.70 ± 1.25 vs. 5.68 ± 1.57, p =.002). The Kaplan–Meier curve showed the intervention group had a significantly delayed first occurrence of delirium compared with the control group (p =.043). Conclusions: The study did not provide significant evidence to support that sensory stimulation could reduce the incidence of delirium, but significant difference on delirium‐free days. Relevance to Clinical Practice: This study provides evidence‐based practice for clinical healthcare providers to adopt the sensory stimulation protocol to prevent delirium, significantly reducing delirium duration and severity. [ABSTRACT FROM AUTHOR]

Introduction: The aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self‐help cognitive behavioral therapy‐enhanced (CBT‐E) for binge‐eating disorder (BED) to a waiting list control condition. Methods: BED patients (N = 212) were randomly assigned to guided self‐help CBT‐E or the 3‐month waiting list. Measurements took place at baseline and the end‐of‐treatment. The cost‐effectiveness analysis was performed using the number of binge‐eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost‐utility analysis was performed using the EuroQol‐5D. Results: The difference in societal costs over the 3 months of the intervention between both conditions was €679 (confidence interval [CI] 50–1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self‐help condition was approximately €18 (CI 1–41). From a societal perspective there was a 96% likelihood that guided self‐help CBT‐E led to a greater number of binge‐eating episodes prevented, but at higher costs. Each additional quality‐adjusted life year (QALY) gained was associated with incremental costs of €34,000 (CI 2494–154,530). With a 95% likelihood guided self‐help CBT‐E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness‐to‐pay threshold of €35,000 per QALY, guided self‐help CBT‐E can be considered cost‐effective with a likelihood of 95% from a societal perspective. Discussion: Guided self‐help CBT‐E is likely a cost‐effective treatment for BED in the short‐term (3‐month course of treatment). Comparison to treatment‐as‐usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. Public Significance: Offering treatment remotely has several benefits for patients suffering from binge‐eating disorders. Guided self‐help CBT‐E is an efficacious and likely cost‐effective treatment, reducing binge eating and improving quality‐of‐life, albeit at higher societal costs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of reconstructive peri‐implantitis treatment. Materials and Methods: Forty participants, with peri‐implantitis and a contained intraosseous defect, were randomized to access flap (control) or access flap with xenograft and collagen membrane (test). All received systemic antimicrobials. Blinded examiners recorded probing depths (PD), bleeding and suppuration on probing (BOP & SOP), soft tissue levels, and marginal bone levels (MBL) at baseline and 12 months. Patient reported outcomes were recorded. The primary outcome was PD change. Results: All 40 participants (40 implants) completed the 12‐month study. The mean (standard deviation) PD reduction (deepest site) was 4.2 (1.8) mm in the control and 3.7 (1.9) mm in the test group. MBL gain (deepest site) was 1.7 (1.6) mm in the control and 2.4 (1.4) mm in the test group. Absence of BOP & SOP was observed at 60% of both control and test implants. Buccal recession was 0.9 (1.6) mm in the control and 0.4 (1.1) mm in the test group. A successful outcome (absence of PD ≥ 5 mm with BOP, absence of SOP and absence of progressive bone loss) was achieved for 90% of the control and 85% of test group implants. No statistically significant differences in clinical or radiographic parameters were found between treatment groups. 30% of participants experienced mild gastro‐intestinal disturbances. Reporting followed CONSORT guidelines. Conclusion: Similar clinical and radiographic improvements at 12 months were observed with high levels of patient satisfaction for both the access flap and xenograft covered by collagen membrane groups. Registered clinical trials.gov. ID:NCT03163602 (23/05/2017). [ABSTRACT FROM AUTHOR]

In a randomized controlled trial, outcomes of different subjects may be independent at baseline, but correlated at a follow‐up measurement due to treatment. This treatment‐related clustering at follow‐up can arise for instance because the treatment is given in a group or because subjects are treated individually but by the same therapist (therapist effect). There is substantial literature on the design and analysis of such trials when estimation of the intervention effect is based on a follow‐up measurement (eg, directly after treatment or at a later time point). However, often the baseline measurement of the outcome is highly correlated with the follow‐up measurement, and this information can be used in the analysis. For a randomized design with a baseline and a follow‐up measurement, we compare sample size requirements for analyses with and without adjustment for this baseline measure. We show that adjusting for baseline reduces required sample size. This reduction depends on the variance of the difference between arms at baseline, the variance of this difference at follow‐up, and the correlation between the two. From this, we derive sample size formulas for partially or fully nested designs, and cluster randomized trials with treatment as a partially or fully cross‐classified factor. Also, we discuss situations where clusters are already present at baseline or where treatment by cluster interaction is present. For the partially nested design, we work out practical design considerations (eg, use of content‐matter input, design factors and optimal allocation ratio) and investigate small sample properties of the sample size formula. [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease (PD) is the second most common neurodegenerative disorder worldwide. Mindfulness and meditation therapies have been demonstrated as effective alternative treatments for patients with neurological disorders. However, the effects of mindfulness and meditation therapies on PD remain unclear. This meta‐analysis investigated the effects of mindfulness and meditation therapies in PD patients. Methods: A literature search was conducted using PubMed, Embase, Cochrane Library, and ClinicalTrials.gov for randomized controlled trials comparing mindfulness and meditation therapies with control treatments in patients with PD. Results: Nine articles involving eight trials were included, with a total of 337 patients. Our meta‐analysis revealed that mindfulness and meditation therapies significantly improved Unified Parkinson's Disease Rating Scale‐Part III score (mean difference [MD] = −6.31, 95% confidence interval [95% CI] = −8.57 to −4.05) and cognitive function (standard mean difference [SMD] = 0.62, 95% CI = 0.23 to 1.02). However, no significant differences were discovered between mindfulness therapies and control in gait velocity (MD = 0.05, 95% CI = −0.23 to 0.34), Parkinson's Disease Questionnaire‐39 Summary Index (MD = 0.51, 95% CI = −1.12 to 2.14), activities of daily living (SMD = −1.65, 95% CI = −3.74 to 0.45), depression (SMD = −0.43, 95% CI = −0.97 to 0.11), anxiety (SMD = −0.80, 95% CI = −1.78 to 0.19), pain (SMD = 0.79, 95% CI = −1.06 to 2.63), or sleep disturbance (SMD = −0.67, 95% CI = −1.58 to 0.24). Conclusion: Mindfulness and meditation therapies may serve as complementary and alternative treatments for PD patients. [ABSTRACT FROM AUTHOR]

Background: The optimal allocation of training time to different intensities in cardiac rehabilitation is still under debate. The objective of this study was to explore whether in a 12‐week cardiac rehabilitation program, replacement of two of four usual continuous endurance training (CET) sessions per week with energy expenditure‐matched high‐intensity interval training (HIIT) affects the trajectories of cardiopulmonary exercise test (CPET) variables such as ventilatory equivalents for O2 (EqO2) and CO2 (EqCO2), and blood lactate (BLa) during CPET. Methods: Eighty‐two male patients undergoing outpatient cardiac rehabilitation after an acute coronary syndrome were randomized to CET (age [mean ± SD] 61.7 ± 9.8 years, body mass index [BMI] 28.1 ± 3.4) or HIIT+CET (60.0 ± 9.4 years, BMI 28.5 ± 3.5). CPET was performed at baseline, after 6 and after 12 weeks. HIIT consisted of ten 60‐s bouts of cycling at an intensity of 100% of the maximal power output (Pmax) achieved in an incremental test to exhaustion, interspersed with 60 s at 20% Pmax. CET was performed at 60% Pmax with equal duration. Training intensities were adjusted after 6 weeks to account for the training‐induced improvement in cardiorespiratory fitness. The entire functions defining the relationship between EqO2, EqCO2, and BLa, with power output were modeled using linear mixed models to assess how these trajectories are affected by HIIT. Results: After 6 and 12 weeks, Pmax increased to 112.9% and 117.5% of baseline after CET, and to 113.9% and 124.7% after HIIT+CET (means). Twelve weeks of HIIT+CET elicited greater reductions of EqO2 and EqCO2 than CET alone (p < 0.0001 each) in a range above 100% baseline Pmax. Specifically, at 100% of baseline Pmax, least squares arithmetic mean EqO2 values of CET and HIIT+CET patients were 36.2 versus 33.5. At 115% and 130% of baseline Pmax, EqO2 values were 41.2 versus 37.1 and 47.2 versus 41.7. Similarly, corresponding EqCO2 values of CET and HIIT+CET patients were 32.4 versus 31.0, 34.3 versus 32.2, and 37.0 versus 34.0. Conversely, mean BLa levels (mM) were not differently affected (p = 0.64). At 100%, 115%, and 130% of baseline Pmax after 12 weeks, BLa levels did not differ to a relevant extent (least squares geometric means, 3.56 vs. 3.63, 5.59 vs. 5.61, 9.27 vs. 9.10). Conclusions: While HIIT+CET reduced ventilatory equivalents more effectively than CET alone, specifically when patients were approaching their maximal performance during CPET, both training strategies were equally effective in reducing BLa levels. [ABSTRACT FROM AUTHOR]

Objective: Eating disorders (EDs) are serious mental illnesses with high mortality and relapse rates and carry significant societal and personal costs. Nevertheless, there are few evidence‐based treatments available. One aspect that makes treatment difficult is the high heterogeneity in symptom presentation. This heterogeneity makes it challenging for clinicians to identify pertinent treatment targets. Personalized treatment based on idiographic models may be well‐suited to address this heterogeneity, and, in turn, presumably improve treatment outcomes. Methods: In the current randomized controlled trial, participants will be randomly assigned to either 20 sessions of enhanced cognitive behavioral therapy (CBT‐E) or transdiagnostic network‐informed personalized treatment for EDs (T‐NIPT‐ED). Assessment of ED symptoms, clinical impairment, and quality of life will occur at pre‐, mid‐, posttreatment, and 1‐month follow‐up. Results: We will examine the acceptability and feasibility of T‐NIPT‐ED compared to CBT‐E. We also will test the initial clinical efficacy of T‐NIPT‐ED versus CBT‐E on clinical outcomes (i.e., ED symptoms and quality of life). Finally, we will test if the network‐identified precision targets are the mechanisms of change. Discussion: Ultimately, this research may inform the development and dissemination of evidence‐based personalized treatments for EDs and serve as an exemplar for personalized treatment development across the broader field of psychiatry. Public Significance: Current evidence‐based treatments for eating disorders result in low rates of recovery, especially for adults with AN. Our study aims to test the feasibility, acceptability, and clinical efficacy of a data‐driven, individualized approach to ED treatment, network‐informed personalized treatment, compared to the current evidence‐based treatment for EDs, Enhanced CBT. Findings have the potential to improve treatment outcomes for EDs by identifying and targeting core symptoms maintaining EDs. [ABSTRACT FROM AUTHOR]

Objective: The aims of this clinical trial were to evaluate the radiographic dimensional changes in alveolar ridge and patient‐reported outcomes following tooth extraction and alveolar ridge preservation (ARP) using either deproteinized bovine bone mineral (DBBM) with EMD or DBBM alone. Methods: Participants requiring at least one posterior tooth extraction and ARP were randomly allocated into two treatment groups: ARP using either DBBM with EMD or DBBM alone. Cone‐beam computed tomography (CBCT) images were recorded immediately prior to extraction and at 6 months. Changes in alveolar ridge height (ARH) and alveolar ridge width (ARW) at 1, 3, and 5 mm were recorded. Results: A total of 18 participants with 25 preserved sites were evaluated. ARH and ARW changed significantly from baseline to 6 months for both treatment groups but the difference between the groups was not statistically significant over the 6‐month follow‐up period (ARH: DBBM/EMD 1.26 ± 1.53 mm vs. DBBM 2.26 ± 1.60 mm; ARW‐1 DBBM/EMD 1.98 ± 1.80 mm vs. DBBM 2.34 ± 1.89 mm). A significant difference, favoring DBBM with EMD group, was observed in percentage of sites that had less than 1 mm loss in ARH (54.5% sites in DBBM/EMD group vs. 14.3% sites in DBBM alone group). The participants' perception of bruising, bleeding, and pain in the first two postoperative days was significantly in favor of DBBM alone group. Conclusions: There were no significant differences in radiographic mean measurements of ARH and ARW following ARB with DBBM and EMD or DBBM alone. [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]

Objective: To investigate whether a virtual reality learning environment (VRLE) enhanced student understanding and knowledge compared with a traditional tutorial. Method: A randomized controlled trial involving medical students from University College Dublin, Ireland. Participants were assigned to an intervention (VRLE involving a 15‐min learning experience on the stages of fetal development) or control (PowerPoint tutorial on the same topic) group. Multiple choice questionnaires (MCQs) assessed knowledge at three time points: preintervention, immediately postintervention, and 1 week postintervention. Primary outcomes were differences in MCQ knowledge scores postintervention between groups. Secondary outcomes included attitudes on the learning experience assessed using the Student Satisfaction and Self‐Confidence in Learning Scale (SCLS) and the Virtual Reality Design Scale (VRDS). Results: No statistically significant between‐group differences were found in the primary outcome assessing postintervention knowledge scores. Within‐group differences in knowledge scores were significant among the three time points for both the intervention (P < 0.01 [95% confidence interval, 5.33–6.19]) and control (P = 0.02 [95% confidence interval, 5.74–6.49]) groups. Mean levels of satisfaction and self‐confidence in learning were higher in the intervention group compared with the control group: 54.2 (standard deviation, 7.5) and 50.5 (standard deviation, 7.2), respectively (P = 0.21). Conclusion: VRLEs are a learning tool that can support knowledge development. Synopsis: This study supports the benefit of three‐dimensional lessons to improve knowledge and understanding of complex topics in obstetrics and gynecology education. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [ABSTRACT FROM AUTHOR]

Adolescents with a visible difference to the face or body (e.g., due to a congenital condition, illness, or injury), may be at risk of elevated psychological distress. Young Person's Face IT (YPF), a web‐based psychosocial intervention, has displayed effectiveness, but no previous study has specifically evaluated its cost‐effectiveness. The aim of our study was to investigate whether YPF could be a cost‐effective alternative for psychosocial support to adolescents distressed by a visible difference, relative to care‐as‐usual (CAU). Within the context of a randomized controlled trial in Norway, 102 participants (43% boys) were allocated to intervention (n = 55) or waiting list control group (n = 47). Mean age was 13.9 years (SD = 1.71; range 11–18), and all self‐identified as experiencing distress related to a visible difference. Participants answered questionnaires including measures of health‐related quality of life and social anxiety at baseline and 3‐month follow‐up. A health economic evaluation using the method of cost‐utility analysis was performed, including quality‐adjusted life‐years (QALYs). Results indicated that the incremental cost‐effectiveness of YPF was 63,641 Norwegian kroner per QALYs gained, which is well within the acceptability threshold in the Norwegian healthcare sector. Hence, YPF could potentially be considered a cost‐effective intervention for adolescents experiencing distress related to a visible difference, but more research is needed that includes comparisons of YPF to other health‐ and societal resources and long‐term follow‐ups. Our study also constitutes an addition to research as, compared to interventions for somatic diseases, there is a lack of studies exploring the cost‐effectiveness of psychological interventions. [ABSTRACT FROM AUTHOR]