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Purpose: This study aimed to determine the validity and reliability of the electronic Compassion Competence Scale (e-CCS). Methods: A cross-sectional, randomized, two-period crossover design was used. Nursing students from four South Korean universities were surveyed between June 2017 and April 2018. The participants were randomly assigned to one of three groups-paper/paper, electronic/electronic, and paper/electronic or electronic/paper-and a test-retest procedure was implemented. The reliability and validity of the e-CCS were evaluated using linear weighted kappa coefficients and intraclass correlation coefficients (ICCs). Internal consistency reliability was verified using linear weighted kappa coefficients and ICCs. Pearson's correlation coefficients between the initial test and retest scores were all statistically significant. Results: The newly developed e-CCS was found to have good reliability and validity. We suggest that future research should increase sample heterogeneity by recruiting diverse age groups, nurses working in different nursing fields, and students from multiple colleges. Conclusion: This electronic instrument will help determine the differences in the level of compassion competence and devise interventions to improve compassion competence in nurses and nursing students. Further studies on enhancing compassion competence among nurses and nursing students may rely on the use of this electronic format. [ABSTRACT FROM AUTHOR]

Objectives: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants. [ABSTRACT FROM AUTHOR]

The herbal medicine Yukgunja-tang has been widely used for the treatment of functional dyspepsia (FD) in the clinical setting of East Asian traditional medicine. This paper presents a protocol for a randomized, assessor-blind, controlled, multicenter, three-arm parallel clinical trial comparing the effectiveness, safety, and cost-effectiveness of Yukgunja-tang with Pyeongwi-san and usual care. A total of 140 participants with Rome IV-diagnosed FD will be randomly assigned to either the Yukgunja-tang (n = 56), Pyeongwi-san (n = 56), or usual care (n = 28) groups. All participants will be educated on dietary guidelines for FD patients. Participants in the Yukgunja-tang and Pyeongwi-san groups will take investigational products for 6 weeks. All participants will be assessed for clinical parameters at weeks 0, 3, 6, 9, and 24. The primary outcome will be measured on the total dyspepsia symptom scale, and the secondary outcome will include the single dyspepsia symptom scale, overall treatment effect, the visual analog scale for dyspepsia, FD-related quality of life, hospital anxiety and depression scale, EuroQol-5 dimension, pattern identification, and serum levels of acyl-ghrelin and deacyl-ghrelin. Adverse events and laboratory tests will be monitored for safety assessment. The results will provide evidence of the effectiveness, safety, and cost-effectiveness of Yukgunja-tang in the treatment of FD. [ABSTRACT FROM AUTHOR]

Background: The transition from teacher‐centred towards student‐centred approaches in English language teaching, accompanied by developments in educational technology, has attracted researchers' attention to reverse teaching or flipped class. The related literature asserts that this mode of instruction might influence instructors' and students' participation in the class. Objectives: To shed more light on the role of flipped class in affecting language learning strategies and skills, this study applied a sequential explanatory mixed‐methods approach to explore the impact of flipped class on English as a foreign language (EFL) learners' writing metacognitive strategies and writing skills. Methods: Forty‐six intermediate EFL learners with an age range of 21–27, studying at a private language institute, were randomly divided into two groups of 23 learners. The two groups were randomly assigned to a flipped class, which received writing metacognitive strategies and writing skills through video clips before the class time, and a non‐flipped class, which received writing metacognitive strategies and writing skills in a conventional way during the class time. Results and Conclusions: The results revealed that both flipped and non‐flipped classes improved the EFL learners' writing metacognitive strategies, writing performance, writing content, and writing organisation. Furthermore, one‐way ANCOVA analyses indicated that the flipped class outperformed the non‐flipped class in writing metacognitive strategies, writing performance, writing content, and writing organisation. Thematic analyses, which were used to help analyse individual semi‐structured interviews, uncovered a number of categories and themes, signifying the flipped learners' positive perceptions towards the flipped class, such as enhancing motivation, self‐confidence, and writing collaboration. Implications: Pedagogical implications were discussed for flipping writing metacognitive strategies and writing skills. Lay Description: What is already known about this topic?: Metacognitive strategies, including planning, monitoring, and evaluation strategies, help English language learners become more successful writers.Writing skills, including writing content, writing organisation, and language use, help learners deal with collaborative writing activities effectively.Flipped class has been shown to be an effective mode of instruction to improve English language learners' language learning strategies and skills. What this paper adds?: Flipped class improves English language learners' writing metacognitive strategies, writing performance, writing content, and writing organisation.Flipped class is more effective than non‐flipped class in improving English language learners' writing metacognitive strategies and writing skills.English language learners' motivation, self‐confidence, and writing collaboration are increased as a result of the flipped writing course. Pedagogical implications: Writing metacognitive strategies and writing skills need to be flipped in English language contexts in order to free up time for more effective in‐class collaborative writing activities. [ABSTRACT FROM AUTHOR]

Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Introduction: Occupational therapy often involves handwriting acquisition practices that include the non‐dominant hand when improvements in the dominant hand function are not possible because of trauma or stroke. This study explored whether character tracing and using a pegboard can effectively improve the handwriting of the non‐dominant hand. Methods: A randomised controlled trial involving 60 healthy university students aged ≥18 years was conducted. Participants were randomly assigned to the writing group, peg group or control group. The character recognition rate was evaluated by computer software. Furthermore, character quality and writing speed were evaluated by humans using global legibility scales. Evaluations were performed before the intervention (baseline) and on days 5 and 10 of the intervention. Using the non‐dominant hand, the writing group traced characters on paper with a ballpoint pen, and the peg group used a pegboard for 15 min/day for 10 days. Results: Compared with the peg and control groups, the writing group showed significant improvements in the character recognition rate and global legibility scale score. However, the global legibility scale score did not improve to the same level as that achieved with the dominant hand. None of the evaluation scores of the peg group showed significant improvements compared with those of the control group. There were no significant differences in improvements in the writing speed of the writing and peg groups compared with the control group. Conclusion: Tracing characters can improve the handwriting ability of the non‐dominant hand, but using a pegboard may be less effective. Future research is needed to examine how much practice is necessary to improve the handwriting ability of the non‐dominant hand sufficiently. [ABSTRACT FROM AUTHOR]

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We investigated the effects of readymade versus self‐generated graphic organizers (GOs) on learning, comparing the performances of undergraduates (N = 81) tasked with learning a multimedia document. This document was either presented on its own (control group), with a readymade GO, or with a blank GO that students had to fill in either before or during the learning of the document. In line with previous research, adding a readymade GO increased students' memorization and transfer scores, compared with controls. By displaying the main ideas in the text and their hierarchical relations, GOs act as visual aids to learning. Results showed that self‐generating a GO was no more beneficial than viewing a readymade GO when students were placed in a dual‐task situation (generation + learning). However, when the students' information processing was guided by sequencing these tasks (generation then learning), they outperformed the control and readymade groups on memorization and comprehension. Lay Description: What is already known about this topic: Graphic organizers (GOs) consist in visual displays showing the main ideas of a text and their interrelations.Adding GOs to pedagogical document have been shown to improve students' learning.However, self‐generating GOs has been proven to be detrimental for learning in several studies. What this paper adds: In previous studies, self‐generation of graphic organizers (GOs) have often been carried out while learning, however this task should be separated from the learning task.In the present study, students' learning performances increased when the self‐generated task was separated from the learning task compared to a condition with a readymade GO.These benefits on learning were not observed when the self‐generated activity was not guided. Implications for practitioners: Graphic organizers gathering all the key elements of a multimedia document and highlighting the structure of this document should be used in order to increase students' learning.Students should not be placed in double‐task situation when learning from a pedagogical document.In‐task guidance should be provided when self‐generative tasks are performed. [ABSTRACT FROM AUTHOR]

Introduction: In this paper, we evaluated the feasibility of a telemedical (TM) support program and its effect on glycemic control in adolescents with type 1 diabetes mellitus (T1DM). Thirty-six adolescents (m=20, median age at the start of the study: 15.3 years (range: 10.7-19.3 years), median age at diagnosis: 9.3 years (2.1-13.8 years), median duration of disease: 6.4 years (1.0-12.8 years), HbA1c>8%, all on intensified insulin therapy) were randomized in a crossover trial over 6 months (3 months with TM, 3 months with conventional support and paper diary (PD)). During the TM phase, the patients sent their data (date, time, blood glucose, carbohydrate intake, insulin dosage) via mobile phone, at least daily, to our server and diabetologists sent back their advice via short message service (SMS) once a week.Results: Glycemic control improved during the TM phase, while it deteriorated during the PD phase: TM-PD group HbA1c (%, median (range)): 9.05 (8-11.3) (at 0 months), 8.9 (6.9-11.3) (at 3 months), and 9.2 (7.4-12.6) (at 6 months), and PD-TM group: 8.9 (8.3-11.6), 9.9 (8.1-11), and 8.85 (7.3-11.7) (p<0.05). Patients rated the TM support program to be a good idea. Technical problems with General Packet Radio Service (GPRS) data transmission led to data loss and decreased patient satisfaction.Conclusion: Our telemedical support program, VIE-DIAB, proved to be feasible in adolescents and helped to improve glycemic control. [ABSTRACT FROM AUTHOR]

Background: In recent years, an increasing number of studies have examined the potential efficacy of cognitive training procedures in individuals with normal ageing and mild cognitive impairment (MCI). Objective: The aims of this study were to (i) evaluate the efficacy of the cognitive Virtual Reality Rehabilitation System (VRRS) combined with anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex compared to placebo tDCS stimulation combined with VRRS and (ii) to determine how to prolong the beneficial effects of the treatment. A total of 109 subjects with MCI were assigned to 1 of 5 study groups in a randomized controlled trial design: (a) face-to-face (FTF) VRRS during anodal tDCS followed by cognitive telerehabilitation (TR) (clinic-atDCS-VRRS+Tele@H-VRRS); (b) FTF VRRS during placebo tDCS followed by TR (clinic-ptDCS-VRRS+Tele@H-VRRS); (c) FTF VRRS followed by cognitive TR (clinic-VRRS+Tele@H-VRRS); (d) FTF VRRS followed by at-home unstructured cognitive stimulation (clinic-VRRS+@H-UCS); and (e) FTF cognitive treatment as usual (clinic-TAU). Results: An improvement in episodic memory was observed after the end of clinic-atDCS-VRRS (p < 0.001). We found no enhancement in episodic memory after clinic-ptDCS-VRRS or after clinic-TAU. Moreover, the combined treatment led to prolonged beneficial effects (clinicatDCS- VRRS+Tele@H-VRRS vs. clinic-ptDCS-VRRS+Tele@H-VRRS: p = 0.047; clinic-atDCS-VRRS+Tele@H-VRRS vs. clinic-VRRS+Tele@H-VRRS: p = 0.06). Discussion: The present study provides preliminary evidence supporting the use of individualized VRRS combined with anodal tDCS and cognitive telerehabilitation for cognitive rehabilitation. [ABSTRACT FROM AUTHOR]

Background: Social prescribing link workers are non-health or social care professionals who connect people with psychosocial needs to non-clinical community supports. They are being implemented widely, but there is limited evidence for appropriate target populations or cost effectiveness. This study aimed to explore the feasibility, potential impact on health outcomes and cost effectiveness of practice-based link workers for people with multimorbidity living in deprived urban communities. Methods: A pragmatic exploratory randomised trial with wait-list usual care control and blinding at analysis was conducted during the COVID 19 pandemic (July 2020 to January 2021). Participants had two or more ongoing health conditions, attended a general practitioner (GP) serving a deprived urban community who felt they may benefit from a one-month practice-based social prescribing link worker intervention.. Feasibility measures were recruitment and retention of participants, practices and link workers, and completion of outcome data. Primary outcomes at one month were health-related quality of life (EQ-5D-5L) and mental health (HADS). Potential cost effectiveness from the health service perspective was evaluated using quality adjusted life years (QALYs), based on conversion of the EQ-5D-5L and ICECAP-A capability index to utility scoring. Results: From a target of 600, 251 patients were recruited across 13 general practices. Randomisation to intervention (n = 123) and control (n = 117) was after baseline data collection. Participant retention at one month was 80%. All practices and link workers (n = 10) were retained for the trial period. Data completion for primary outcomes was 75%. There were no significant differences identified using mixed effects regression analysis in EQ-5D-5L (MD 0.01, 95% CI -0.07 to 0.09) or HADS (MD 0.05, 95% CI -0.63 to 0.73), and no cost effectiveness advantages. A sensitivity analysis that considered link workers operating at full capacity in a non-pandemic setting, indicated the probability of effectiveness at the €45,000 ICER threshold value for Ireland was 0.787 using the ICECAP-A capability index. Conclusions: While the trial under-recruited participants mainly due to COVID-19 restrictions, it demonstrates that robust evaluations and cost utility analyses are possible. Further evaluations are required to establish cost effectiveness and should consider using the ICE-CAP-A wellbeing measure for cost utility analysis. Registration: This trial is registered on ISRCTN. Title: Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas. Trial ID: ISRCTN10287737. Date registered 10/12/2019. Link: https://www.isrctn.com/ISRCTN10287737 [ABSTRACT FROM AUTHOR]

Aim: This study was conducted to determine the effect of music on the pain, anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy. Methods: This study was conducted on patients with hematological malignancies. Music was used with the intervention group. Patients' pain, anxiety, and comfort levels were measured. In addition, qualitative data were obtained through in-depth interviews with patients. Results: A significant difference (p < 0.05) was found between the experimental and control groups regarding pain, comfort and anxiety levels following the application of music. It was found that there was a negative correlation between comfort and pain (r=-0.442 p < 0.001) and between comfort and anxiety (r=-0.544 p < 0.001). As a result of qualitative interviews, patients mentioned the relaxing effect of music and the reduction of anxiety and pain levels. They also stated that music can be utilized as an alternative method. Conclusion: According to the results of the present study, music reduced the pain and anxiety levels of the patients in bone marrow aspiration and biopsy and increased their comfort levels. We can say that music can be used in the clinic as a non-pharmacological method for pain, anxiety and comfort. Clinical Trials Number: NCT05895357 (Date:08/06/2023). [ABSTRACT FROM AUTHOR]

Purpose: Eczema is a pediatric skin disease that affects the psychosocial well-being of both children and their parent caregivers. This paper outlines a protocol for an experimental study that evaluates the effectiveness of a psychosocial empowerment program for children with eczema and their parent caregivers. Method: A multi-center randomized controlled trial is proposed, where parent–child dyads are randomized into two arms: an intervention group and wait-list control group. The intervention is delivered to participants in a parallel group format based on the Integrative Body-Mind-Spirit model which focuses on holistic well-being. Quality of life is measured before and after the intervention is provided, and five weeks after the intervention has been completed. Discussion: The suggested model fills a research gap in existing interventions, and provides new knowledge by evaluating the effectiveness of a tailored psychosocial intervention, delivered in group settings, for parent–child dyads affected by eczema. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus.Methods: The cognition substudy is an integral part of the ongoing event-driven, randomised, double blind CARdiOvascular safety of LINAgliptin (CAROLINA®) trial, which evaluates the effect of treatment with linagliptin versus glimepiride on cardiovascular outcomes. CAROLINA® includes patients with type 2 diabetes mellitus with sub-optimal glycaemic control at elevated cardiovascular risk. The substudy will evaluate patients randomised and treated who have a baseline Mini Mental State Examination (MMSE) score ≥ 24, documented years of formal education with at least one valid cognitive assessment at baseline and during follow-up. The primary cognitive outcome is the occurrence of accelerated cognitive decline at the end of follow-up. The two treatment groups will be compared by using a logistic regression. Accelerated cognitive decline is defined as a rate of cognitive decline that falls at or below the 16th percentile of decline for the whole cohort on either the MMSE or a combined score of the trail making and verbal fluency test. Potential confounders are taken into account at an individual patient level, using a regression based index.Discussion: Between December 2010 and December 2012, 6042 patients were randomised and treated with either linagliptin (5 mg) or glimepiride (1-4 mg) once daily in CAROLINA®. Cognitive tests were conducted in nearly 4500 participants at baseline and are scheduled for two subsequent assessments, after 160 weeks of follow-up and end of follow-up. This substudy of the ongoing CAROLINA® trial will establish if linagliptin is superior to glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. Final results are expected in 2019.Trial Registration: ClinicalTrials.gov Identifier: NCT 01243424 . [ABSTRACT FROM AUTHOR]

Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.Trial Registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016. [ABSTRACT FROM AUTHOR]

INTRODUCTION Tobacco use remains the single most modifiable cause of adverse pregnancy outcomes. It is crucial to be able to accurately quantify the burden of tobacco exposure on both the mother and fetus to have better measures of efficacy with interventions being studied. METHODS This is a descriptive and exploratory study conducted within a randomized controlled trial. Pregnant smoking and non-smoking women were followed from ≤22 weeks' gestation through delivery with monthly maternal smoking questionnaires, urine cotinine levels, and collection of maternal and infant hair and nail samples, at delivery. Nicotine was extracted and measured (ng/mg) using high-performance liquid chromatography with electrochemical detection. RESULTS Forty-six mother--infant dyads (34 pregnant smokers and 12 pregnant non-smokers) had successful completion of maternal and infant hair and nails samples. The median hair nicotine levels of the smoking mothers and their infants was significantly higher than those of the non-smokers (1.015 vs 0.037 ng/ mg, p<0.05 for the mothers; 0.445 vs 0.080 ng/mg, p<0.01 for the infants). Similarly, the median nail nicotine levels for smoking mothers and their infants were significantly higher than the non-smokers (2.130 vs 0.056 ng/mg, p<0.01 for the mothers; 0.594 vs 0.132 ng/mg, p<0.05 for the infants). We found a moderate but significant correlation between maternal hair and nail nicotine (r=0.64, p<0.001), infant hair and nail nicotine (r=0.64; p<0.001), maternal and infant hair nicotine (r=0.61, p<0.001), and maternal and infant nail nicotine levels (r=0.58, p<0.001). CONCLUSIONS Our study shows that both infant hair and nail nicotine levels are valid biomarkers of intrauterine tobacco smoke exposure, and can be used to identify prenatal smoke exposure, correlating well with the level of maternal nicotine exposure. [ABSTRACT FROM AUTHOR]

Background: Missing outcome data can lead to bias in the results of systematic reviews. One way to address missing outcome data is by requesting the data from the trial authors, but non-response is common. One way to potentially improve response rates is by sending study participants advance communication. During the update of a systematic review examining the effect of pre-notification on response rates, study authors needed to be contacted for further information. This study was nested within the systematic review by randomising authors to receive a notification of the upcoming request for information. The objective was to test if pre-notification increased response rates.Methods: The participants were study authors included in the systematic review, whose studies were at unclear risk of bias. The intervention was a pre-notification of the request for further information, sent 1 day before the request. The outcome was defined as the proportion of authors who responded to the request for information. Authors were randomised by simple randomisation. Thirty three authors were randomised to the pre-notification arm, and 42 were randomised to the control arm. Authors were blinded to the possibility of an alternative condition.Results: All authors randomised were analysed. 14/33 (42.4%) authors in the pre-notification arm had returned responses to the questionnaire, and 18/42 (42.9%) in the control arm. There was no evidence of a difference between these groups (absolute difference = - 0.5, 95% CI (- 23.4 to 22.5%), p = 1). We received no complaints about receiving the pre-notification.Conclusions: This study's results do not support the hypothesis that pre-notification increases response from study authors being contacted for a request for more information. However, the study has a low power, and the results may not generalise to other contexts, methods of administering a pre-notification, or study populations.Trial Registration: Registration and protocol: This trial is not registered with any trial registry. However, the protocol was posted in advance on the Open Science Framework website and is available on the Open Science Framework website: DOI: https://doi.org/10.17605/OSF.IO/MSV2W or https://osf.io/msv2w/. [ABSTRACT FROM AUTHOR]

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

(1) Background: This study examines the effects of a 6-week swimming intervention on motor competence in children. (2) Methods: A total of 107 children (n = 52 boys, n = 55 girls) aged 7.8 ± 0.63 years that were recruited from five primary schools in central England participated in this study, undertaking either an aquatic intervention once a week for six weeks or acting as a control group completing their usual physical education program. Participants underwent pre- and post-assessments of general motor competence using the Test of Gross Motor Development, Third Edition (TGMD-3) (a process measure) and a composite of 10 m running sprint time and standing long jump distance (product measures). Aquatic motor competence was assessed via the Aquatic Movement Protocol (AMP). Fear of drowning and swimming opportunities were also assessed by implementing a questionnaire. (3) Results: Following a mixed-model ANOVA, an overall main effect was found from pre (40.05 ± 13.6) to post (48.3 ± 18.6) for TGMD-3 scores (p < 0.05) and pre (38.7 ± 31.7) to post (50.6 ± 36.8) for AMP scores (p = 0.001). A negative significant relationship was found between AMP scores with both fear of water (p = 0.01) and fear of drowning (p < 0.05). A positive significant relationship was found between swimming opportunities and AMP score (p = 0.001). (4) Conclusions: The aquatic-based intervention improves not only aquatic motor competence but also transfers improvements in dryland movement competencies. Future research should look to implement control groupings which do not participate in swimming to further investigate the difference between swimmers and non-swimmers; however, due to swimming being a part of the national curriculum in England, this may not be feasible. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the efficacy of a self-guided Web-based cognitive behaviour therapy (CBT) intervention compared to an attention control in improving cancer-related distress, health-related quality of life (HRQOL), and maladaptive coping, among people recently diagnosed with cancer.Methods: Sixty individuals with cancer diagnosed in the previous 6 months and receiving treatment with curative intent were randomised to receive either the 6-week intervention Cancer Coping Online (CCO: n = 30) or the 6-week Web-based attention control (n = 30). Outcome measures, including cancer distress (the Posttraumatic Stress Scale - Self-Report), general distress (Depression Anxiety Stress Scale), quality of life (EORTC QLQ-C30), and coping (mini-MAC), were administered at baseline, immediately post-intervention, and at 3 and 6 months post-intervention.Results: Significant main effects for time were found for cancer distress, global QOL, physical function, role function, social function, and anxious preoccupation. Post hoc between-group comparisons showed CCO participants had statistically significantly higher physical functioning compared to controls at 3 months of follow-up (d = -0.52, p = 0.02). Furthermore, compared to controls, post hoc comparisons found moderate between-group effect sizes favouring CCO post-intervention for cancer distress (d = 0.43) and anxious preoccupation (d = 0.38), and at 6 months of follow-up for global QOL (d = -0.43).Conclusions: These results provide preliminary support for the potential efficacy of a self-guided Web-based CBT programme in improving aspects of HRQOL, cancer-related distress, and anxious preoccupation after cancer diagnosis. This paper provides justification for, and will help inform the development of, subsequent larger multi-site studies. [ABSTRACT FROM AUTHOR]

The National Criminal Justice Drug Abuse Treatment Studies research program conducted cluster randomized trials to test an organizational process improvement strategy for implementing evidence-based improvements in HIV services for preventing, detecting, and/or treating HIV for individuals under correctional supervision. Nine research centers conducted cluster randomized trials in which one correctional facility used a modified Network for Improvement of Addiction Treatment (NIATx) change team approach to implementing improved HIV services and the other facility used their own approach to implement the improved HIV services. This paper examines whether the intervention increased the perceived value of HIV services among staff of correctional and community HIV organizations. Baseline and follow-up measures of the perceived acceptability, feasibility, and organizational support for implementing HIV service improvements were collected from correctional, medical, and community HIV treatment staff. Results indicated that the perceived acceptability and feasibility of implementing HIV services improved among staff in the facilities using the modified NIATx change team approach as compared to staff in the comparison facilities. [ABSTRACT FROM AUTHOR]

Aims: The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.Methods: Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.Discussion: The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation. [ABSTRACT FROM AUTHOR]

Introduction/Objectives: Annually, HPV infections result in $775 million in direct medical costs and approximately 46 000 new cases of HPV-associated cancers. Safe and highly effective vaccines have been available to prevent HPV for children/adolescents since 2006. Vaccination rates remain low, especially in rural areas. Parental attitudes and beliefs affect HPV vaccination rates. Methods: We developed, tested, and administered a survey that asked how parents and healthcare providers interacted about the HPV vaccine following a healthcare visit with an age-eligible child, as part of a multicomponent randomized controlled trial designed to improve HPV vaccination rates in rural Oregon. The 21-item survey assessed parents' information-seeking behavior, knowledge about HPV cancer risk reduction, the HPV vaccine series, and their vaccine confidence. Results: Forty-three participants (59.7%) were in the intervention group; 29 (40.3%) were controls. Over 90% of healthcare visits were illness, injury, sports physical, or well-child visits (n = 67 or 93.1%), and 6.9% of visits were vaccine-specific. No statistically significant differences were found between study groups for healthcare visits. Over half the parents reported having discussions about HPV and the HPV vaccine (54.5%) with their care providers, 31.3% had recently learned about HPV, HPV risks, and the HPV vaccine prior to the visit, 83.1% were knowledgeable about cancers associated with HPV, and 79.2% were considering vaccinating their child(ren), which did not differ between study groups. Conclusions: Knowledge about HPV-related cancers and consideration for vaccinating children was higher than expected, but not associated with the intervention tested. [ABSTRACT FROM AUTHOR]

Introduction: Perinatal depression is common among women living with HIV, but depression care is limited in low-resource settings. We examined (1) characteristics of women receiving Problem Solving Therapy (PST) versus antidepressant therapy (ADT), (2) treatment response by modality, and (3) correlates of treatment response. Methods: This analysis used data from 191 Ugandan women in the intervention arm of a cluster randomized controlled trial of task-shifted, stepped-care depression treatment for pregnant women living with HIV (PWLWH). Treatment response was defined as scoring < 5 on the nine-item Patient Health Questionnaire (PHQ-9). Bivariate analysis and multivariable logistic regression were used to examine characteristics of women by treatment group and correlates of treatment response. Results: Of 134 participants with depression, 129 (96%) were treated: 84 (65%) received PST and 45 (35%) received ADT. Severe depression at treatment initiation was more common in those receiving ADT (28.9% versus 4.8%, Fischer's Exact Test < 0.001). Treatment response was higher for PST (70/84; 83.3%) than ADT (30/45; 66.7%; p =.03). ADT side effects were rare and minor; no infants had serious congenital defects. Of 22 participants (19%) who did not respond to treatment, only five received intensified management. Social support and interpersonal violence were associated with treatment response (adjusted odds ratio, [aOR] = 3.06, 95% CI = 1.08–8.66 and aOR = 0.64, 95% CI = 0.44–0.93). Discussion: Both depression treatment modalities yielded high response rates in Ugandan PWLWH; ADT was well-tolerated. Our results highlight a need to build capacity to implement the stepped-care protocol for non-responders and screen for social support and interpersonal violence. Significance: What is Already Known on this Subject?Prior research has demonstrated the feasibility and effectiveness of delivering collaborative care for depression in low-resource settings including Uganda. What this Study adds?Both Problem-Solving Therapy and antidepressant therapy yielded high treatment response rates among pregnant women living with HIV in Uganda who met criteria for depression, and antidepressant therapy was well tolerated. This study highlights a need to build capacity to implement the task-shifted stepped-care protocol for women whose depression does not respond to initial treatment, and to screen for social support and interpersonal violence. [ABSTRACT FROM AUTHOR]

Background: Conveying information to parents is a core part of pediatric oncology nursing; however, most published interventions do not tailor information to individual parental needs. Objective: To evaluate the effect on parental illness-related stress of person-centered information provided to parents of children with cancer. Methods: A multicenter, unblinded randomized controlled trial with two parallel arms recruiting parents of children diagnosed within the past two months from two tertiary children's cancer centers in Sweden. Parents were randomized using sealed envelopes prepared and opened by an independent person. Parents in the intervention arm met four times with experienced nurses trained in the intervention, whereas controls received standard care. The effect of the intervention was measured five times regarding parents' illness-related stress. Secondary outcomes were psychosocial states, experiences with healthcare providers, and received information. Further, we collected process data on the intervention's content and fidelity. Results: Of the 32 parents included and analyzed in the study, 16 were randomized to the intervention, which addressed a broad variety of topics. The intervention increased parents' knowledge about the biophysiological and functional aspects of their child's illness, but it had no measurable effect on their distress. Discussion: Although fidelity to the intervention protocol was sufficient, the study was flawed by recruitment difficulties, primarily due to organizational factors, which may have prevented us from observing any possible effects on psychosocial distress. Having a person-centered perspective could be promising for future studies aimed at parents of children with cancer. (Registered at Clinicaltrials.gov, number NCT02332226.) [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of a structured goal-setting and tailored follow-up rehabilitation intervention with existing rehabilitation in patients with rheumatic and musculoskeletal diseases. Design: A pragmatic stepped-wedge cluster randomized trial. Setting: Eight rehabilitation centers in secondary healthcare, Norway. Participants: A total of 374 adults with rheumatic and musculoskeletal diseases were included in either the experimental (168) or the control group (206). Interventions: A new rehabilitation intervention which comprised structured goal setting, action planning, motivational interviewing, digital self-monitoring of goal progress, and individual follow-up support after discharge according to patients' needs and available resources in primary healthcare (the BRIDGE-intervention), was compared to usual care. Main measures: Patient-reported outcomes were collected electronically on admission and discharge from rehabilitation, and after 2, 7, and 12 months. The primary outcome was patients' goal attainment measured by the Patient Specific Functional Scale (0–10, 10 best) at 7 months. Secondary outcome measures included physical function (30-s Sit-To-Stand test), health-related quality of life (EQ-5D-5L-index), and self-assessed health (EQ-VAS). The main statistical analyses were performed on an intention-to-treat basis using linear mixed models. Results: No significant treatment effects of the BRIDGE-intervention were found for either primary (Patient Specific Functional Scale mean difference 0.1 [95% CI: −0.5, 0.8], p = 0.70), or secondary outcomes 7 months after rehabilitation. Conclusion: The BRIDGE-intervention was not shown to be more effective than existing rehabilitation for patients with rheumatic and musculoskeletal diseases. There is still a need for more knowledge about factors that can improve the quality, continuity, and long-term health effects of rehabilitation for this patient group. [ABSTRACT FROM AUTHOR]

Background Secondary arm lymphoedema continues to affect at least 20% of women after treatment for breast cancer requiring lifelong professional treatment and self-management. The holistic practice of yoga may offer benefits as an adjunct self-management option. The aim of this small pilot trial was to gain preliminary data to determine the effect of yoga on women with stage one breast cancer-related lymphoedema (BCRL). This paper reports the results for the primary and secondary outcomes. Methods Participants were randomised, after baseline testing, to receive either an 8-week yoga intervention (n = 15), consisting of a weekly 90-minute teacher-led class and a 40-minute daily session delivered by DVD, or to a usual care wait-listed control group (n = 13). Primary outcome measures were: arm volume of lymphoedema measured by circumference and extracellular fluid measured by bioimpedance spectroscopy. Secondary outcome measures were: tissue induration measured by tonometry; levels of sensations, pain, fatigue, and their limiting effects all measured by a visual analogue scale (VAS) and quality of life based on the Lymphoedema Quality of Life Tool (LYMQOL). Measurements were conducted at baseline, week 8 (post-intervention) and week 12 (four weeks after cessation of the intervention). Results At week 8, the intervention group had a greater decrease in tissue induration of the affected upper arm compared to the control group (p = 0.050), as well as a greater reduction in the symptom sub-scale for QOL (p = 0.038). There was no difference in arm volume of lymphoedema or extra-cellular fluid between groups at week 8; however, at week 12, arm volume increased more for the intervention group than the control group (p = 0.032). Conclusions An 8-week yoga intervention reduced tissue induration of the affected upper arm and decreased the QOL sub-scale of symptoms. Arm volume of lymphoedema and extra-cellular fluid did not increase. These benefits did not last on cessation of the intervention when arm volume of lymphoedema increased. Further research trials with a longer duration, higher levels of lymphoedema and larger numbers are warranted before definitive conclusions can be made. [ABSTRACT FROM AUTHOR]

Background: We implemented a comprehensive intervention program targeting general practice staff, that proved successful in optimizing practice organization and clinical decision-making. In this paper, health-related quality of life (HRQL) is investigated as a clinical outcome.Objective: To evaluate the effect of the implementation of an intervention program on the HRQL in patients at high cardiovascular risk.Research Design: Randomized controlled trial. Intervention practices (n = 62) received a comprehensive intervention program (by means of outreach visitors) lasting 21 months. HRQL of patients at high cardiovascular risk was assessed by the MOS 36-Item Short-Form Health Survey (SF-36), at baseline and after intervention. Three patient categories were distinguished: diabetes mellitus, cardiovascular disease and hypertension.Results: HRQL deteriorated in all respondents, but more pronounced in the control group. In diabetes patients the differences between intervention and control group were significant for the Vitality and Mental Health scales, with mean difference in change of 3.93 (95% CI: 1.08-6.78) and 3.71 (95% CI: 0.73-6.68), respectively. Patients with cardiovascular disease had significantly different changes on three scales: physical functioning (3.57, 95% CI: 0.71-6.43), vitality (3.01, 95% CI: 0.72-5.30) and social functioning (3.96, 95% CI: 0.50-7.42). In patients with hypertension, there were no differences between the intervention and control group.Conclusion: Our comprehensive intervention program resulted in changes in HRQL on several domains, particularly in patients with diabetes and cardiovascular disease. [ABSTRACT FROM AUTHOR]

Background: Lifetime trajectories of mental ill-health are often established during adolescence. Effective interventions to prevent the emergence of mental health problems are needed. In the current study we assessed the efficacy of the cognitive behavioural therapy (CBT)-informed Climate Schools universal eHealth preventive mental health programme, relative to a control. We also explored whether the intervention had differential effects on students with varying degrees of social connectedness. Method: We evaluated the efficacy of the Climate Schools mental health programme (19 participating schools; average age at baseline was 13.6) v. a control group (18 participating schools; average age at baseline was 13.5) which formed part of a large cluster randomised controlled trial in Australian schools. Measures of internalising problems, depression and anxiety were collected at baseline, immediately following the intervention and at 6-, 12- and 18-months post intervention. Immediately following the intervention, 2539 students provided data on at least one outcome of interest (2065 students at 18 months post intervention). Results: Compared to controls, we found evidence that the standalone mental health intervention improved knowledge of mental health, however there was no evidence that the intervention improved other mental health outcomes, relative to a control. Student's social connectedness did not influence intervention outcomes. Conclusion: These results are consistent with recent findings that universal school-based, CBT-informed, preventive interventions for mental health have limited efficacy in improving symptoms of anxiety and depression when delivered alone. We highlight the potential for combined intervention approaches, and more targeted interventions, to better improve mental health outcomes. [ABSTRACT FROM AUTHOR]

Abstract Background: Chronic muscle diseases (MD) are progressive and cause wasting and weakness in muscles and are associated with reduced quality of life (QoL). The ACTMuS trial examined whether Acceptance and Commitment Therapy (ACT) as an adjunct to usual care improved QoL for such patients as compared to usual care alone. Methods: This two-arm, randomised, multicentre, parallel design recruited 155 patients with MD (Hospital and Depression Scale ⩾ 8 for depression or ⩾ 8 for anxiety and Montreal Cognitive Assessment ⩾ 21/30). Participants were randomised, using random block sizes, to one of two groups: standard medical care (SMC) (n = 78) or to ACT in addition to SMC (n = 77), and were followed up to 9 weeks. The primary outcome was QoL, assessed by the Individualised Neuromuscular Quality of Life Questionnaire (INQoL), the average of five subscales, at 9-weeks. Trial registration was NCT02810028. Results: 138 people (89.0%) were followed up at 9-weeks. At all three time points, the adjusted group difference favoured the intervention group and was significant with moderate to large effect sizes. Secondary outcomes (mood, functional impairment, aspects of psychological flexibility) also showed significant differences between groups at week 9. Conclusions: ACT in addition to usual care was effective in improving QoL and other psychological and social outcomes in patients with MD. A 6 month follow up will determine the extent to which gains are maintained. [ABSTRACT FROM AUTHOR]

Objectives: Assess (a) the variability of behaviour problems in children with Hyperkinetic Disorder/Attention‐DeficitHyperactivity Disorder (HKD/ADHD) across a range of family situations and (b) the degree to which behaviour in each situation can be modified through a cognitive behavioural parent training (CBPT). Furthermore (c), compare the effectiveness of training in two different formats and (d) test the proposition that group treatment benefits behaviour in a wider range of situations than individual treatment. Method: A registered multicentre randomized controlled trial comparing individual and group parent training to treatment‐as‐usual (TAU) for N = 237 children with HKD/ADHD. A German version of the Home Situations Questionnaire (HSQ) was employed to examine behaviour problems across a range of family situations, treatment‐related changes post‐treatment and at 6‐month follow‐up, while controlling for medication status. Results: Parents reported considerable variance in severity of behaviour problems across situations. All groups improved with time, but individual and group CBPT led to significantly greater improvement than TAU in many family situations. Results present situation‐specific treatment trajectories and demonstrate somewhat greater impact of individual compared with group training in certain situations post‐training and 6 months later. Conclusions: CBPT clearly adds to TAU (with effect sizes in the small to moderate range depending on situation). Individual was somewhat more successful than group format (which did not succeed in a wider range of situations). HSQ situations reveal a differentiated picture of child behaviour and treatment results. Situation‐specific assessment with an instrument like the HSQ offers promising perspectives that invite further development. [ABSTRACT FROM AUTHOR]

Background: Many patients undergoing anaesthesia and surgery experience postoperative complications. Our aim was to investigate whether a systematic follow-up smartphone-based assessment, using recovery assessment by phone points (RAPP) compared with standard care, had a positive effect on day surgery patients' postoperative recovery. We also investigated whether there were differences in women and men's recovery and recovery scores.Methods: The study was a single-blind, multicentre randomized controlled trial. A total of 997 patients were randomly allocated to either RAPP or standard care. The Swedish web version of a quality of recovery (SwQoR) questionnaire was used to evaluate the patients' postoperative recovery, either on paper or using an application (RAPP) on postoperative days seven and 14.Results: On postoperative day seven the RAPP group reported significantly better values in seven out of 24 items of the SwQoR: sleeping difficulties; not having a general feeling of wellbeing; having difficulty feeling relaxed/comfortable; and dizziness; headache; pain in the surgical wound; and a swollen surgical wound compared with the control group, implying a good postoperative recovery. Both men and women in the RAPP group reported significantly better values (and, hence good postoperative recovery) compared with the control group in the items sleeping difficulties; not having a general feeling of wellbeing and pain in the surgical wound.Conclusions: Measurement of patient-reported outcomes using a smartphone-based application was associated with decreased discomfort from several postoperative symptoms. Systematic e-assessment can thereby increase patients' quality of recovery and identify key areas for improvement in perioperative care.Clinical Trial Registration: NCT02492191. [ABSTRACT FROM AUTHOR]

Background: The PARAMEDIC cluster randomised trial evaluated the LUCAS mechanical chest compression device, and did not find evidence that use of mechanical chest compression led to an improvement in survival at 30 days. This paper reports patient outcomes from admission to hospital to 12 months after randomisation.Methods: Information about hospital length of stay and intensive care management was obtained through linkage with Hospital Episode Statistics and the Intensive Care National Audit and Research Centre. Patients surviving to hospital discharge were approached to complete questionnaires (SF-12v2, EQ-5D, MMSE, HADS and PTSD-CL) at 90days and 12 months. The study is registered with Current Controlled Trials, number ISRCTN08233942.Results: 377 patients in the LUCAS arm and 658 patients in the manual chest compression were admitted to hospital. Hospital and intensive care length of stay were similar. Long term follow-up assessments were limited by poor response rates (53.7% at 3 months and 55.6% at 12 months). Follow-up rates were lower in those with worse neurological function. Among respondents, long term health related quality of life outcomes and emotional well-being was similar between groups. Cognitive function, measured by MMSE, was marginally lower in the LUCAS arm mean 26.9 (SD 3.7) compared to control mean 28.0 (SD 2.3), adjusted mean difference -1.5 (95% CI -2.6 to -0.4).Conclusion: There were no clinically important differences identified in outcomes at long term follow-up between those allocated to the mechanical chest compression compared to those receiving manual chest compression. [ABSTRACT FROM AUTHOR]

Aims Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC. Methods and results This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was –11.6 m, 95% confidence interval: –36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin). Conclusion The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year. Registration ClinicialTrials.gov: NCT02341716. [ABSTRACT FROM AUTHOR]

Standard empirical studies are needed despite three decades of research on child sexual abuse prevention programs (CSAPPs). This study aimed to investigate the effects of CSAPP on the child's sexual safety. A multicenter, random cluster, quasi-experimental controlled survey was conducted in a 1:1 ratio in Tehran, Iran, from May to December 2019 in seventy 5- to 6-years-old children from 10 kindergartens. In groups of 7 to 8, the intervention group participated in four sessions of 45 minutes of face-to-face sexual self-care training, 3 to 4 days apart. The control groups received one session on accident safety. Knowledge, self-protective skills, fear, and self-disclosure were assessed respectively by the "Personal Safety Questionnaire (PSQ)," "What If Situation Test (WIST)," "Fear Assessment Thermometer Scale (FATS)," and researcher-made questions before and 8 weeks after the intervention. At the baseline, children obtained 70% of knowledge and 45% of protective skills scores. After the intervention, knowledge, protective skills, and detection of "appropriate requests" were significantly promoted (p <.001). Detecting "inappropriate requests" did not differ; however, all quadruple skills (Say, Do, Tell, and Report) improved significantly. "Girl sex" and "parents' education" were related factors promoting children's protective skills. Sexual abuse self-disclosure was 4.2% (n = 3), and one child reported child sexual abuse (CSA) only after the intervention. Despite the lack of formal education, children's basic knowledge reflects the importance of parents in preventing CSA. However, the CSAPP significantly improved children's skills and revealed one CSA case. CSAPP should not focus solely on risky scenarios because if children cannot distinguish between safe and unsafe situations, they will experience unnecessary anxiety. Even after recognizing the dangerous conditions, CSA prevention will practically fail without appropriate reactions such as escaping and reporting. CSAPP should emphasize individual rights such as body ownership and assertiveness skills and explain the "danger of known people" with detailed scenarios, especially in collectivistic and traditional societies. [ABSTRACT FROM AUTHOR]

FindMyApps is a web-based selection-tool and errorless learning training program to help people with mild dementia/Mild Cognitive Impairment (MCI) and caregivers find user-friendly apps. In preparation of a definitive trial, the impact and feasibility of the FindMyApps intervention on self-management and engagement in meaningful activities, including social participation, was explored. An exploratory pilot randomised controlled trial (trial registration approval number: NL7210) with pre/post measurements was conducted with community-dwelling people with mild dementia/MCI and their caregivers (n = 59) in the Netherlands. Dyads in the experimental group (n = 28) received training to use the tablet and FindMyApps, and the errorless learning method was taught to their caregivers. Control group dyads (n = 31) received a tablet (without FindMyApps), instructions on tablet-use and links to dementia-friendly apps. Validated instruments were used to assess person with dementia's self-management, meaningful activities and social participation, caregiver's sense of competence and both their quality of life. No statistical significant group differences on the outcomes were found. Small to moderate effect-sizes in favour of the FindMyApps group were found for self-management and social participation. Caregivers tended to have more positive care experiences. Subgroup analyses showed that people older than 70 benefitted more from FindMyApps regarding self-management and higher educated people benefitted more regarding social participation. FindMyApps is feasible for the target group and may have potential to improve self-management and social participation. For a future definitive effectiveness trial a larger sample size is recommended, as well as taking into account the possible impact of education and age. The FindMyApps program is feasible for people with dementia/MCI and may have potential to improve their self-management and social participation. Informal caregivers may develop a more positive care experience when utilizing FindMyApps to find suitable apps for self-management and social participation for the person with dementia/MCI. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome. Methods: In this multi-center, randomized, controlled study, 140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table, with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening, 100 mL each time), and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2–6), both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Traditional Chinese Medicine Symptom Scale (TCMSS), and Clinlcal Global Impression (CGI) scores at the 2nd, 4th, and 6th weekends of treatment, HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ⩽7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded. Results: From baseline to week 6, the HAMD-17 scores decreased 10.2 ± 4.0 and 9.1 ± 4.9 points in the JJD and paroxetine groups, respectively (P=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (P=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients, respectively (P=0.128). The differences of CGI scores at the 6th week were not statistically significant (P>0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (P=0.001 and P=0.014). The HAMA scores declined 8.1 ± 3.0 and 6.9 ± 4.3 points from baseline to week 6 in the JJD and paroxetine groups, respectively (P=0.905 between groups). At 4th week of treatment, there was a significant difference in HAMA between the two groups (P=0.037). TCMSS decreased 11.4 ± 5.1, and 10.1 ± 6.8 points in the JJD and paroxetine groups, respectively (P=0.080 between groups). At the 6th week, the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14% vs. 22.86%, P<0.05). Conclusion: Compared with paroxetine, JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome, with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922) [ABSTRACT FROM AUTHOR]

Purpose We studied the effectiveness of a new cardiac rehabilitation (CR) program developed for patients with obesity compared with standard CR on HRQOL and psychosocial well-being. Materials and methods OPTICARE XL was a multicentre RCT in patients with cardiac disease and obesity (Netherlands Trial Register: NL5589). Patients were randomized to OPTICARE XL CR (n = 102) or standard CR (n = 99). The one-year OPTICARE XL CR group program included endurance and resistance exercises, behavioural coaching, and after-care. Standard CR consisted of a 6- to 12-week endurance exercise group program, and cardiovascular lifestyle education. Primary endpoint was HRQOL (MacNew) at six months post CR. Second, we assessed anxiety and depression (both HADS), fatigue (FSS), and participation in society (USER-P). Results In both groups, improvements in HRQOL were observed six months post CR. Mean HRQOL improved from 4.92 to 5.40 in standard CR [mean change (95% CI): 0.48 (0.28, 0.67)] and from 4.96 to 5.45 in OPTICARE XL CR (mean change (95% CI): 0.49 (0.29, 0.70), without between-group differences. Psychosocial well-being improvements within both groups were obtained at six months post CR, regardless of allocated program. Conclusions OPTICARE XL CR did not have added value in improving HRQOL and psychosocial well-being in patients with obesity. More than a third of cardiac patients suffers from obesity, and standard cardiac rehabilitation (CR) programs are suboptimal in this increasing patient population. The OPTICARE XL CR program is a state-of-the art, one-year CR program designed for patients with obesity including aerobic and strength exercises, behavioural coaching towards a healthy diet and an active lifestyle, and after-care. Improvements in HRQOL and psychosocial well-being were comparable between patients with obesity allocated to standard CR and OPTICARE XL CR. Therefore, there was no additional benefit of OPTICARE XL CR. [ABSTRACT FROM AUTHOR]

Background: This study aimed to compare the consistency of anesthesia consciousness index (Ai) with that of bispectral index (BIS) in monitoring the depth of anesthesia (DOA) during sevoflurane anesthesia, to reveal the optimal cutoff values in different states of consciousness, and explore the stability of DOA monitoring during intraoperative injurious stimulation. Methods: We enrolled 145 patients (97 men and 48 women) from 10 medical centers. General anesthesia was induced using intravenous anesthetics and maintained with sevoflurane. Ai and BIS values were recorded. Results: The mean difference between the Ai and BIS was-0.1747 (95% confidence interval, -0.6660 to 0.3166; p = 0.4857). The regression equation of Ai and BIS from the Deming regression analysis was y = 5.6387 + 0.9067x (y is BIS, x is Ai), and the slope and intercept were statistically significant. Meanwhile, the receiver operating characteristic curve analysis of anesthesia-induced unconsciousness, loss of consciousness, and recovery of consciousness revealed that the accuracy of Ai and BIS were similar. In addition, the optimal cutoff values of the different states of consciousness were not sensitive to age, and both Ai and BIS had no correlation with hemodynamics. Conclusion: We conclude that Ai and BIS show no systematic deviation in readings with high consistency, similar accuracy, and good stability; these insights provide more data for clinical application. [ABSTRACT FROM AUTHOR]

Background: Anaemia is highly prevalent in people with advanced, palliative cancer yet sufficiently effective and safe treatments are lacking. Oral iron is poorly tolerated, and blood transfusion offers only transient benefits. Intravenous iron has shown promise as an effective treatment for anaemia but its use for people with advanced, palliative cancer lacks evidence. Aims: To assess feasibility of the trial design according to screening, recruitment, and attrition rates. To evaluate the efficacy of intravenous iron to treat anaemia in people with solid tumours, receiving palliative care. Design: A multicentre, randomised, double blind, placebo-controlled trial of intravenous iron (ferric derisomaltose, Monofer®). Outcomes included trial feasibility, change in blood indices, and change in quality of life via three validated questionnaires (EQ5D5L, QLQC30, and the FACIT-F) over 8 weeks. (ISRCTN; 13370767). Setting/Participants: People with anaemia and advanced solid tumours who were fatigued with a performance status ⩽2 receiving support from a specialist palliative care service. Results: 34 participants were randomised over 16 months (17 iron, 17 placebo). Among those eligible 47% of people agreed to participate and total study attrition was 26%. Blinding was successful in all participants. There were no serious adverse reactions. Results indicated that intravenous iron may be efficacious at improving participant haemoglobin, iron stores and select fatigue specific quality of life measures compared to placebo. Conclusion: The trial was feasible according to recruitment and attrition rates. Intravenous iron increased haemoglobin and may improve fatigue specific quality of life measures compared to placebo. A definitive trial is required for confirmation. [ABSTRACT FROM AUTHOR]

Objective: To determine whether a single session of botulinum toxin type A (BTA) injections into both hands more effectively decreases the frequency of systemic sclerosis–associated Raynaud's phenomenon (SSc‐RP) episodes than placebo. Methods: This multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group phase III trial in patients with SSc‐RP assessed the effect of 50‐unit BTA or placebo injections into the palms of both hands around each neurovascular bundle during 1 session in winter. The primary end point was the between‐group difference in the median change in the number of RP episodes from baseline (day 0) to 4 weeks postinjection. Values between the groups were compared with the Wilcoxon rank‐sum test. Results: The intent‐to‐treat analysis included 46 BTA‐treated patients and 44 placebo recipients. At 4 weeks after assigned treatment injections, the median number of daily RP episodes decreased comparably in the BTA and placebo groups (median change –1 episode/day [interquartile range (IQR) –1.5, 0 episodes/day] and –1 episode/day [IQR –2.5, 0 episodes/day], respectively) (P = 0.77 versus placebo). Moreover, change in Raynaud's Condition Score, quality of life assessed by Health Assessment Questionnaire disability index, and hand function assessed by shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and Cochin Hand Function Scale from baseline to follow‐up weeks 4, 12, and 24 did not differ significantly between groups. The BTA group experienced transient hand muscle weakness significantly more frequently (P = 0.003). Conclusion: Neither the primary nor secondary end points were reached, and our results do not support any beneficial effect of palmar BTA injections to treat SSc‐RP. [ABSTRACT FROM AUTHOR]

Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0–100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512. [ABSTRACT FROM AUTHOR]

Aim: This study piloted a digital self-help intervention facilitating healthy lifestyle for patients with mental health problems in primary care. Background: Patients with mental health problems show more unhealthy lifestyle behaviors than the general population and prior research indicates that healthy lifestyle behaviors can improve mental health. Methods: This pilot study assessed use of a self-help digital intervention for healthy lifestyle promotion and included an embedded randomized recruitment trial, where all patients were randomized to digital self-help plus treatment as usual (TAU) or to TAU only. Patients seeking help for mental health problems were recruited from two primary care clinics in Stockholm, Sweden, and offered participation in a healthy lifestyle promotion study via digital self-help. Outcome measures included use-related assessment of inclusion and follow-up rates at both clinics, participant characteristics, and intervention adherence. Secondary outcomes included depression (the Patient Health Questionnaire-9) and anxiety (the GAD-7) up to 10 weeks, and changes in alcohol and tobacco use, physical activity, and diet. Results: The study included 152 patients. The recruitment rate, initially low, increased after involving the clinicians more and maintaining more frequent contact with the patients. The 10-week missing data rate was 33/152 (22%). Participants were 70% (106/152) women, with a mean age of 42 years (SD = 14); fewer than half (38%, n = 58/152) had one or more high-risk unhealthy behaviors at inclusion. Psychiatric symptoms were moderate at baseline and declined in both groups after 10 weeks (d = 0.57–0.75). No between-group effects over time occurred on depression (b = 0.3 [95% CI −1.6, 2.2]; d = 0.06), anxiety (b = −0.7 [−2.5, 1.2]; d = 0.13), or lifestyle behaviors (b = 0.01 [−0.3, 0,3]; d = −0.01). Conclusions: Recruitment routines seemed to be decisive for reaching as many patients as possible. The relatively low rate of unhealthy lifestyle behaviors and small effect sizes suggests that the intervention may only suit patients at risk. Trial registration: ClinicalTrials.gov NCT03691116 (01/10/2018), focusing on the embedded trial. Retrospectively registered for the first clinic and prospectively for the second clinic. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although positive youth development (PYD) programs have demonstrated effectiveness in improving adolescent reproductive health outcomes, there is a lack of evidence on effective school‐based interventions designed especially for high school settings. This study examined the efficacy of Peer Group Connection (PGC‐HS), a school‐based PYD program, in improving sexual health outcomes for high school participants. METHODS: A total of 1523 ninth‐grade students at 18 schools were randomly assigned to be offered PGC‐HS or a classes‐as‐usual control condition during 2016 to 2017 and 2017 to 2018 school years. Impacts were assessed on three confirmatory and 6 exploratory outcomes via self‐reported participant questionnaire data collected at the beginning of 10th grade. RESULTS: Although the offer of PGC‐HS had no statistically detectable effect on confirmatory behavioral outcomes (sexual initiation, frequency of sex, and number of sexual partners) at 10th grade follow‐up, causal impact estimates indicate that PGC‐HS participants were less likely than control participants to ever have had vaginal sex. PGC‐HS participants also scored higher on decision‐making skills and perceived connection to peer connectedness. CONCLUSIONS: Results suggest that by building social and emotional skills and helping students form supportive peer relationships, PGC‐HS may encourage students to make healthier choices and avoid risky behaviors during a critical period in high school, thus, reducing the risk of pregnancy. [ABSTRACT FROM AUTHOR]

Background and Hypothesis Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia, yet a significant proportion of individuals on clozapine continue to experience disabling symptoms, despite being treated with an adequate dose. There is a need for adjunct treatments to augment clozapine, notably for negative and cognitive symptoms. One such potential agent is the glutathione precursor N -acetylcysteine (NAC). Study Design A randomized double-blind, multi-center, placebo-controlled trial for clozapine patients with enduring psychotic symptoms (n = 84) was undertaken to investigate the efficacy of adjunctive NAC (2 g daily) for negative symptoms, cognition and quality of life (QoL). Efficacy was assessed at 8, 24, and 52 weeks. Study Results NAC did not significantly improve negative symptoms (P =.62), overall cognition (P =.71) or quality of life (Manchester quality of life: P =.11; Assessment of quality of life: P =.57) at any time point over a 1-year period of treatment. There were no differences in reported side effects between the groups (P =.26). Conclusions NAC did not significantly improve schizophrenia symptoms, cognition, or quality of life in treatment-resistant patients taking clozapine. This trial was registered with "Australian and New Zealand Clinical Trials" on the 30 May, 2016 (Registration Number: ACTRN12615001273572). [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease reduces patients' function, activities of daily living, and quality of life, and increases their guardians' burden of care. This study verified the effectiveness of a multimodal rehabilitation programme for patients with Parkinson's disease. Trial design: This study was a multicentre parallel randomised controlled, single-blind, trial conducted in three hospitals in Korea. Methods: A central randomisation centre used computer generated tables to randomly allocate 60 of 75 patients with Parkinson's disease who fulfilled the study requirements into experimental (n = 30; multimodal rehabilitation; consisting of daily living training, guardian education, home environment modification, fine muscle exercise, balance training, and training using auxiliary tools performed 50 min per session, twice a week, in 10 sessions) and control (n = 30; traditional rehabilitation; consisting of task-oriented training, joint exercise, and daily living training performed 50 min per session, twice a week, in 10 sessions) groups. Results: Multimodal rehabilitation for Parkinson's disease significantly improved the activities of daily living (p < 0.01) and quality of life of patients (p < 0.001) and eased the guardians' burden of care (p < 0.001). Conclusions: Multimodal rehabilitation is suggested to improve activities of daily living, quality of life of patients with Parkinson's disease, and reduce the burden of care of their guardians. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to compare the effect of emotional freedom technique (EFT) on sleep quality and happiness of women who underwent breast cancer surgery and lived in military and nonmilitary families. Design and Methods: The patients were randomly divided into four groups of military intervention (n = 34), nonmilitary intervention (n = 33), military control (n = 31), and nonmilitary control (n = 35). Data were collected using demographic information form, Pittsburgh Sleep Quality Index, and Oxford Happiness Questionnaire. Findings: The mean scores of sleep quality and happiness in military and nonmilitary intervention groups improved significantly immediately and 1 month after the intervention compared to control groups (p < 0.001). However, there was no statistically significant difference between the military and nonmilitary intervention groups regarding the mean scores of sleep quality and happiness before, immediately, and 1 month after the intervention (p > 0.05). Practice Implications: Given the efficacy of EFT in improving sleep quality and happiness, it is recommended that this technique be taught to nurses to implement in the entire process of providing nursing care to cancer patients. [ABSTRACT FROM AUTHOR]

Background: Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression - three features of The Healthlines Study. Advance notification, including a photograph and using action-oriented email subject lines might increase response rates, but require further investigation. We examined the effectiveness of these interventions in three embedded Healthlines studies.Methods: Based in different trial sites, participants with depression were alternately allocated to be pre-called or not ahead of the 8-month follow-up questionnaire (Study 1), randomized to receive a research team photograph or not with their 12-month questionnaire (Study 2), and randomized to receive an action-oriented ('ACTION REQUIRED') or standard ('Questionnaire reminder') 12-month email reminder (Study 3). Participants could complete online or postal questionnaires, and received up to five questionnaire reminders. The primary outcome was completion of the Patient Health Questionnaire (PHQ-9). Secondary outcome measures were the number of reminders and time to questionnaire completion.Results: Of a total of 609 Healthlines depression participants, 190, 251 and 231 participants were included in Studies 1-3 (intervention: 95, 126 and 115), respectively. Outcome completion was ≥90 % across studies, with no differences between trial arms (Study 1: OR 0.38, 95 % CI 0.07-2.10; Study 2: OR 0.84, 95 % CI 0.26-2.66; Study 3: OR 0.53 95 % CI 0.19-1.49). Pre-called participants were less likely to require a reminder (48.4 % vs 62.1 %, OR 0.41, 95 % CI 0.21-0.78), required fewer reminders (adjusted difference in means -0.67, 95 % CI -1.13 to -0.20), and completed follow-up quicker (median 8 vs 15 days, HR 1.35, 95 % CI 1.00-1.82) than control subjects. There were no significant between-group differences in Studies 2 or 3.Conclusions: Eventual response rates in this trial were high, with no further improvement from these interventions. While the photograph and email interventions were ineffective, pre-calling participants reduced time to completion. This strategy might be helpful when the timing of study completion is important. Researchers perceived a substantial benefit from the reduction in reminders with pre-calling, despite no overall decrease in net effort after accounting for pre-notification.Trial Registration: Current Clinical Trials ISRCTN14172341. [ABSTRACT FROM AUTHOR]

Aims The hybrid comprehensive telerehabilitation (HCTR) consisting of telecare (with psychological telesupport), telerehabilitation, and remote monitoring of cardiovascular implantable electronic devices might be an option to improve both physical capacity and depressive symptoms. The aim of the study was to investigate the influence of HCTR on depressive symptoms and physical capacity in heart failure (HF) patients in comparison with usual care (UC). Methods and results The present analysis formed part of a multicentre, randomized trial that enrolled 850 HF patients (New York Heart Association I–III, left ventricular ejection fraction ≤ 40%). Patients were randomized 1:1 to HCTR or UC. Patients underwent an HCTR programme (1 week in hospital and 8 weeks at home; exercise training 5 times weekly) or UC with observation. The Beck Depression Inventory II (BDI-II) score (cut point for depression ≥ 14) was used to assess depression and the physical capacity was measured by peak oxygen consumption (peak VO2; mL/kg/min). Measurements were made before and after 9-week intervention/observation (HCTR/UC group). Both groups were comparable in terms of demographic and clinical characteristics. In HCTR group, at entry, 23% of the sample obtained BDI-II scores ≥14 vs. 27.5% in UC group. There were no significant differences between groups regarding ΔBDI-II score (P = 0.992) after 9-week HCTR/UC. There was a significant improvement in physical capacity only in the HCTR group in both patients with (P = 0.033) and without (P < 0.001) depression. Conclusions In HF patients, HCTR provided similar reduction of depressive symptoms as UC. HCTR resulted in a significant improvement in physical capacity in patients with and without depression. [ABSTRACT FROM AUTHOR]