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Objective: Computer-assisted child-focused interventions are expected to improve efficiency and personalization of therapist-led treatments for children and adolescents. However, therapist-led, outpatient interventions using computer assistance are lacking for children with oppositional defiant disorder (ODD) or conduct disorder (CD). The present randomized controlled trial examined the efficacy of individualized computer-assisted social skills training for children with aggressive behavior compared to a resource activation intervention.Method: A total of 100 children aged 6-12 years with a diagnosis of ODD/CD and peer-related aggression were randomly (1:1) assigned to either individually delivered computer-assisted social skills training (ScouT) or an individually delivered supportive resource activation treatment (STARK). The primary outcome was parent-rated peer-related aggression, assessed with the respective scale of the Questionnaire for Aggressive Behavior of Children (FAVK) and measured at pre-assessment and after the 16-week intervention (post-assessment). Further parent-, self-, teacher- and/or clinician-rated outcomes included ODD and CD symptoms, a wide range of behavioral and emotional symptoms, callous-unemotional traits, functional impairment, and quality of life.Results: After correcting for multiple testing, analyses of covariance comparing the efficacy of ScouT to the efficacy of STARK yielded small to moderate treatment effects in favor of the ScouT condition regarding parent-rated peer-related aggression (primary outcome; d = -0.64, 95% CI = -1.05, -0.24), parent-rated callous and uncaring traits, and parent-rated quality of life. However, the analyses did not reveal any significant effects for self- or teacher-rated peer-related aggression assessed with the respective scale of the FAVK (self-report: d = -0.21, 95% CI = -0.69, 0.29; teacher rating: d = -0.17, 95% CI = -0.56, 0.22). Moreover, after controlling for multiple comparisons, no significant effects emerged for the following: parent-, self-, and teacher-rated adult-related aggression; parent-, self-, teacher-, and clinician-rated ODD and CD symptoms; parent-, self-, and teacher-rated emotional and behavioral symptoms; and parent-rated functional impairment.Conclusion: According to parent ratings, school-age children with disruptive behavior disorders and peer-related aggression seem to benefit more from individualized, computer-assisted social skills training than from resource activation treatment. However, this conclusion is limited by the missing effects on the clinician-, self-, and teacher-rated measures.Clinical Trial Registration Information: Treatment of Children With Peer Related Aggressive Behavior (ScouT); https://clinicaltrials.gov/; NCT02143427. [ABSTRACT FROM AUTHOR]

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be the lack of time and training of surgeons and anaesthesiologists. We therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery.Methods: The present study is a single-centre, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. We plan to randomize 251 patients. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting 4 weeks before surgery compared to patients in the advice-only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include the length of hospital stay, cost of care, quality of life, smoking abstinence, and reduction in nicotine consumption.Discussion: The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing surgery.Trial Registration: BASEC #2021-02004; ClinicalTrials.gov: NCT05192837 . Registered on January 14, 2022. [ABSTRACT FROM AUTHOR]

Background: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone.Methods: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events.Results: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64).Conclusions: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT01070771. [ABSTRACT FROM AUTHOR]

Background and Objective: Zishen Pingchan granule (ZPG), a traditional Chinese herbal recipe for treating Parkinson's disease (PD), is usually used as an add-on drug with some antiparkinsonian drugs in China. The objectives of this study were to evaluate the efficacy, safety, and tolerability of ZPG combined with pramipexole in the treatment of depression in PD (dPD).Methods: A 12-week, multicenter, randomized, double-blind, and placebo-controlled study on ZPG was performed on a total of 200 patients who were treated with pramipexole but still had mild to moderate depressive symptoms. Patients were randomly divided into ZPG (n = 100) or placebo (n = 100). The primary effective result was the mean change from the baseline on the Hamilton Depression Scale 17 items (HAM-D-17) over 12 weeks and the clinical efficacy rate. Secondary endpoints were the mean change from the baseline in the Geriatric Depression Scale (GDS-15), Unified Parkinson's disease rating scale Part III (UPDRS III), Parkinson's quality of life scale (PDQ-8), and Parkinson's disease sleep scale (PDSS-2) over 12 weeks.Results: After 12 weeks of treatment, ZPG significantly reduced the mean [95% confidence interval] HAMD score vs. placebo (- 1.43 scores [- 2.50, - 0.36]; p = 0.009). The clinical remission rate and responders of the ZPG group were higher than those of the placebo (46.1% vs. 31.0%; p = 0.041; 34.8% vs. 18.4%; p = 0.014). A significant improvement in the PDSS-2 score was also observed in the ZPG group compared with that in the placebo group (- 3.56 scores [- 5.77, - 1.35]; p = 0.002). A total of 7 patients (7.1%) in the ZPG group had mild adverse events (AEs) vs 9 patients (9%) in the placebo group. No severe AEs were observed in either group. The randomization and controlled clinical study revealed that ZPG was effective, safe, and well-tolerated.Conclusion: ZPG combined with pramipexole further reduced the depressive symptoms and improved the sleeping quality of PD patients. Trial registration The protocol was retrospectively registered at the Chinese Clinical Trial Registry, Unique identifier: ChiCTR1800019942, date of registration: December 9, 2018; http://www.chictr.org.cn/showproj.aspx?proj=30432. [ABSTRACT FROM AUTHOR]

Background: There is a need for high-quality research regarding exercise interventions for persons with anxiety disorders. We investigate whether a 12-week exercise intervention, with different intensities, could reduce anxiety symptoms in patients with anxiety disorders.Methods: 286 patients were recruited from primary care in Sweden. Severity of symptoms was self-assessed using the Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S). Participants were randomly assigned to one of two group exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation.Results: Patients in both exercise groups showed larger improvements in both anxiety and depressive symptoms compared to the control group. No differences in effect sizes were found between the two groups. To study a clinically relevant improvement, BAI and MADRS-S were dichotomized with the mean change in the control group as reference. In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively. There was a significant intensity trend for improvement in anxiety symptoms.Limitations: The use of self-rating measures which bears the risk of an under- or overestimation of symptoms.Conclusions: A 12-week group exercise program proved effective for patients with anxiety syndromes in primary care. These findings strengthen the view of physical exercise as an effective treatment and could be more frequently made available in clinical practice for persons with anxiety issues. [ABSTRACT FROM AUTHOR]

Objective: Family caregivers (FCs) of cancer patients often experience high distress. This randomized clinical trial assessed the feasibility and preliminary effects of an intervention to improve FC supportive care.Method: A pragmatic and minimal intervention to improve FC supportive care was developed and pretested with FCs, oncology team, and family physicians to assess its relevance and acceptability. Then, FCs of lung cancer patients were randomized to the intervention or the control group. The intervention included (1) systematic FC distress screening and problem assessment in the first months after their relative cancer diagnosis, and every 2 months after; (2) privileged contact with an oncology nurse to address FC problems, provide emotional support and skills to play their caregiving role; (3) liaison with the family physician of FCs reporting high distress (distress thermometer score ≥4/10) to involve them in the provision of supportive care. Distress, the primary outcome, was measured every 3 months, for 9 months. Secondary outcomes included quality of life, caregiving preparedness, and perceived burden. At the end of their participation, a purposive sample of FC from the experimental group was individually interviewed to assess the intervention usefulness. Content analysis was performed.Results: A total of 109 FCs participated in the trial. FC distress decreased over time, but this reduction was observed in both groups. Similar results were found for secondary outcomes. However, FCs who received the intervention felt better prepared in caregiving than controls (p = 0.05). All 10 interviewed FCs valued the intervention, even though they clearly underused it. Knowing they could contact the oncology nurse served as a security net.Significance Of Results: Although the intervention was not found effective, some of its aspects were positively perceived by FCs. As many of them experience high distress, an improved intervention should be developed to better support them. [ABSTRACT FROM AUTHOR]

Background: Caring for someone with dementia is associated with negative and positive experiences. There is little evidence based on large datasets.Objective: To present data around the experience of caring for someone with dementia, to identify support (emotional and practical) needs, and inform future service provision.Methods: A mixed-methods study embedded in the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) Randomized Controlled Trial. We administered questionnaires on strain, quality of life (QoL), and perceived health to 301 caregivers and assessment of cognitive performance, depression, anxiety, and disability in activities of daily living to 301 participants with dementia. Data were analyzed through descriptive and modelling statistics. A subsample of 20 patient-caregiver dyads were qualitatively interviewed. Data around caregivers' experience of providing care were extrapolated and analyzed through inductive thematic analysis.Results: There were significant negative associations between caregiver strain and QoL (p < 0.01) and between caregiver age and QoL (p < 0.01), and significant positive associations between caregiver strain and disability (p < 0.01), cognitive impairment (p < 0.01), depression (p < 0.05), and anxiety of the person with dementia (p < 0.05). Older caregivers reported a lack of support, reinforced by their reluctance to seek help. All caregivers reported contradictory emotions associated with caring and accumulation of strain over time.Conclusion: While there is recognition that it is essential to support caregivers, dedicated intervention programs, and support strategies to respond to the needs of older caregivers are still needed. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to investigate the effectiveness of a Computer-based Cognitive Behavioral Therapy (CCBT) and identify the characteristics of depressed adolescents that participated in the CCBT program.Methods: Screening tests for depression and help-seeking variables were conducted in school-aged Korean adolescents (n= 376, mean age=15.71 years, 53.7% female). The number of adolescents that scored above the threshold for mild depression (PHQ-9, CES-D) was 139. Fifty adolescents agreed to participate in the randomized controlled trial (RCT) of CCBT program. Twenty-five adolescents were randomly assigned to the treatment group, and the other 25 to the waitlist control group. The treatment group engaged in CCBT with therapeutic support. To identify variables affecting the outcomes, the quality of their homework compliance also was assessed.Results: Participants (n=50) who agreed to participate in the CCBT program demonstrated different help-seeking attitudes - a greater recognition of the need for help and lower interpersonal openness - compared to the adolescents (n=87) who did not participate (t = -2.93, p < .01; t = 3.50, p < .001). The treatment group showed significant improvements in depression, self-esteem, and quality of life compared to the waitlist group. Adolescents with high homework compliance showed a significant decrease in the depression scores compared to adolescents with low homework compliance.Limitations: Small sample size, no follow-up assessments.Conclusion: CCBT could be an effective alternative for depressed adolescents, especially those who tend to have low interpersonal openness. To improve the effects of CCBT, therapeutic support needs to be provided. [ABSTRACT FROM AUTHOR]

Background: Patients with unipolar depressive disorder are frequently hospitalized, and the period following discharge is a high-risk-period. Smartphone-based treatments are receiving increasing attention among researchers, clinicians, and patients. We aimed to investigate whether a smartphone-based monitoring and treatment system reduces the rate and duration of readmissions, more than standard treatment, in patients with unipolar depressive disorder following hospitalization.Methods: We conducted a pragmatic, investigator-blinded, randomized controlled trial. The intervention group received a smartphone-based monitoring and treatment system in addition to standard treatment. The system allowed patients to self-monitor symptoms and access psycho-educative information and cognitive modules. The patients were allocated a study-nurse who, based on the monitoring data, guided and supported them. The control group received standard treatment. The trial lasted six months, with outcome assessments at 0, 3, and 6 months.Results: We included 120 patients with unipolar depressive disorder (ICD-10). Intention-to-treat analyses showed no statistically significant differences in time to readmission (Log-Rank p=0.9) or duration of readmissions (B=-16.41,95%CI:-47.32;25.5,p=0.3) (Primary outcomes). There were no differences in clinically rated depressive symptoms (p=0.6) or functioning (p=0.1) (secondary outcomes). The intervention group had higher levels of recovery (B=7,29, 95%CI:0.82;13,75,p=0.028) and a tendency towards higher quality of life (p=0.07), wellbeing (p=0,09) satisfaction with treatment (p=0.05) and behavioral activation (p=0.08) compared with the control group (tertiary outcomes).Limitations: Patients and study-nurses were unblinded to allocation.Conclusions: We found no effect of the intervention on primary or secondary outcomes. In tertiary outcomes, patients in the intervention group reported higher levels of recovery compared to the control group. [ABSTRACT FROM AUTHOR]

Objectives: There is little evidence to guide fluid administration to patients admitted to the ICU following cardiac surgery. This study aimed to determine if a protocolized strategy known to reduce fluid administration when compared with usual care reduced ICU length of stay following cardiac surgery.Design: Prospective, multicenter, parallel-group, randomized clinical trial.Setting: Five cardiac surgical centers in New Zealand conducted from November 2016 to December 2018 with final follow-up completed in July 2019.Patients: Seven-hundred fifteen patients undergoing cardiac surgery; 358 intervention and 357 usual care.Interventions: Randomization to protocol-guided strategy utilizing stroke volume variation to guide administration of bolus fluid or usual care fluid administration until desedation or up to 24 hours. Primary outcome was length of stay in ICU. Organ dysfunction, mortality, process of care measures, patient-reported quality of life, and disability-free survival were collected up to day 180.Measurements and Main Results: Overall 666 of 715 (93.1%) received at least one fluid bolus. Patients in the intervention group received less bolus fluid (median [interquartile range], 1,000 mL [250-2,000 mL] vs 1,500 mL [500-2,500 mL]; p < 0.0001) and had a lower overall fluid balance (median [interquartile range], 319 mL [-284 to 1,274 mL] vs 673 mL [38-1,641 mL]; p < 0.0001) in the intervention period. There was no difference in ICU length of stay between the two groups (27.9 hr [21.8-53.5 hr] vs 25.6 hr [21.9-64.6 hr]; p = 0.95). There were no differences seen in development of organ dysfunction, quality of life, or disability-free survival at any time points. Hospital mortality was higher in the intervention group (4% vs 1.4%; p = 0.04).Conclusions: A protocol-guided strategy utilizing stroke volume variation to guide administration of bolus fluid when compared with usual care until desedation or up to 24 hours reduced the amount of fluid administered but did not reduce the length of stay in ICU. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of studying creatine in juvenile dermatomyositis (JDM). Secondary objectives were to determine the effect of creatine on muscle function and metabolism, aerobic capacity, fatigue, physical activity, and quality of life (QOL), as well as its safety.Methods: We conducted a 6-month, double-blind, randomized, multiple-baseline design; patients were assigned to creatine or placebo. Feasibility was assessed using attended study visits, completed study procedures, and adherence. Muscle function, aerobic capacity, and muscle strength were assessed with standardized exercise tests. Muscle metabolism was assessed using a 31-Phosphorus Magnetic Resonance Spectroscopy protocol. Fatigue, physical activity, and QOL were assessed by questionnaires. Statistical significance was estimated using a randomization (permutation) test. Changes in outcome measures taken at baseline and end-of-study were calculated using paired t-tests.Results: Median (range) adherence to the study drug was 88.5% (20.5-95.5%) and the proportion of subjects with 80% adherence or higher was 76.9%. There were no missed study visits. There were no statistically significant changes in muscle function, strength, aerobic capacity, disease activity, fatigue, physical activity, or QOL while subjects were receiving creatine compared to placebo. There were statistically significant adaptations in muscle metabolism (e.g., decrease in change in muscle pH following exercise, and decrease in phosphate/phosphocreatine ratio) at the end-of-study compared to baseline. There were no significant adverse effects.Conclusion: Creatine supplementation in children with JDM is feasible to study, and is safe and well-tolerated; it may lead to improvements in muscle metabolism. [ABSTRACT FROM AUTHOR]

Background: A Growing body of literature indicates therapeutic effectiveness of mindfulness for mental disorders. Only few trials have been conducted with schizophrenia spectrum disorders (SSD), mostly in outpatient settings. Primary objective was to assess feasibility, acceptability, and preliminary outcomes of mindfulness-based group therapy (MBGT) for in-patients with SSD.Methods: A pre-registered randomized controlled trial was conducted to assess feasibility and acceptability of the MBGT. The primary outcome was mindfulness measured with the Southampton Mindfulness Questionnaire (SMQ). Secondary outcomes were rater-blinded positive- and negative symptoms, depression, social functioning, and self-reported mindfulness, depression, anxiety, psychological flexibility, quality of life, and medication regime at baseline, post-intervention, and follow-up (Clinical Trails NCT03671005).Results: 40 participants received either treatment-as-usual (TAU; n=19) or (MBGT+TAU; n = 21) for four weeks. At post-intervention, protocol adherence was 95.2%, and retention rate was 95%. ANCOVA revealed significant improvements in the MBGT+TAU for the primary outcome SMQ as well as negative symptoms at post-intervention between groups. In exploratory analyses, secondary outcomes showed medium-to-large pre-to-post-intervention effects on mindfulness, positive-, negative-, and depressive symptoms, psychological flexibility, quality of life, and social functioning for MBGT+TAU and small-to-moderate changes on positive symptoms and social functioning for TAU. No serious adverse effects were reported.Conclusions: MBGT appears feasible and acceptable for in-patient settings, with high protocol adherence and retention rates. Preliminary findings highlight a proof of concept of MBGT and various improvements in clinical- and process dimensions. A fully powered trial is warranted to determine efficacy, cost-efficiency, and longitudinal changes based on these promising outcomes. [ABSTRACT FROM AUTHOR]

Background: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.Methods: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.Results: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.Limitations: Results are limited to green professions and representativeness might be restricted by self-selection of participants.Conclusion: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.Trial Registration: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).Study Design: Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).Results: CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).Conclusions: Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to compare the effect of ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy on long term secondary outcomes of the MYOMEX-trial, regarding quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control. A cost-analysis was also performed. Short-term primary and secondary outcomes are reported elsewhere.Study Design: A double-blind, randomized, controlled, non-inferiority trial in nine hospitals in the Netherlands. Participants were randomized in a 1:1 ratio (block size of four, stratified per hospital) to either UPA or GnRHa pre-treatment. Additional placebo injections containing saline, respectively daily placebo tablets were given to both groups to ensure double-blinding. Surgery was performed within a month after the last tablet. Women were followed up until six months post-surgery.Results: A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017. Uterine volume at six weeks post-operative did not differ significantly between both pre-treatment groups with 170.1 cm3 (106.8-243.5; N = 29) vs. 152.8 cm3 (92.3-205.6; N = 23) for the UPA- and GnRHa-group respectively (p = 0.423). Hemoglobin levels six weeks post-operatively recovered back to baseline and were not significantly different between groups with 7.7 mmol/L for the UPA- vs. 8.1 mmol/L for the GnRHa-group (p = 0.157; mean difference -0.4 (CI -0.9, 0.2). Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups. Symptom severity scores also decreased significantly at 6 week post-operatively compared to baseline, but did not differ between the treatment groups. Fibroid characteristics at baseline (e.g. mean diameter of largest fibroid) appeared not to be a confounding factor. An exploratory cost analysis showed no significant differences in absenteeism costs, total healthcare and societal costs, after adjustment for confounding factors.Conclusion: Pre-treatment prior to laparoscopic myomectomy with UPA compared to GnRHa has similar effects on bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life from baseline up to six months post-operative. Due to the small sample size, these findings should be interpreted with caution. Also, no firm conclusions on costs could be made. [ABSTRACT FROM AUTHOR]

Background: Cancer-related fatigue represents one major cause of reduced quality of life in cancer patients and can seriously affect the physical, emotional, and cognitive functioning impeding coping with the disease. Options for effective treatment of cancer-related fatigue are limited, consisting only of non-pharmacologic interventions like physical activity, psychosocial, and mind-body interventions. Recent evidence suggests that vitamin D3 supplementation might alleviate cancer-related fatigue. However, confirmation in a randomized controlled trial is needed.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 456 colorectal cancer (CRC) patients aged 18 years and older are being recruited in three German rehabilitation clinics. Study inclusion requires hospitalization of at least 3 weeks at such a clinic, a diagnosis of non-metastatic CRC (stage I-III), surgical removal of the tumor within the past 9 months, and season-adapted vitamin D insufficiency or deficiency. Eligible patients are randomly assigned to a personalized regimen of vitamin D3 or placebo for 12 weeks. In the intervention group, a loading dose of 20,000 or 40,000 IU vitamin D3 will be administered daily during the first 11 days, followed by a maintenance dose of 2000 IU daily. Patients will complete questionnaires for secondary outcomes (fatigue subdomains, quality of life and subdomains, depression, functional well-being, and infection frequency). Blood and urine samples will be collected for analyses of safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, and renal impairment) and efficacy biomarkers (25-hydroxyvitamin D, HbA1c, white blood cell count, leukocyte subtype counts, serum C-reactive protein, uric acid, creatinine, triglycerides, total, low- and high-density lipoprotein cholesterol).Discussion: This trial tests whether a personalized vitamin D3 dosing regimen reduces or prevents fatigue among non-metastatic CRC patients by treating the underlying vitamin D deficiency/insufficiency. If efficacy can be confirmed, personalized vitamin D3 supplementation could be used as a tertiary prevention measure in addition to non-pharmacological treatments of cancer-related fatigue in CRC patients. We expect to detect an effect of vitamin D3 supplementation on secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia.Trial Registration: European Clinical Trials Database: EudraCT-No: 2019-000502-30, January 21, 2019; German Clinical Trials Register (DRKS): DRKS00019907 , April 30, 2019. [ABSTRACT FROM AUTHOR]

Background: Up to 75% of women diagnosed with breast cancer report chemotherapy-related cognitive changes (CRCC) during treatment, including decreased memory, attention, and processing speed. Though CRCC negatively impacts everyday functioning and reduces overall quality of life in women diagnosed with breast cancer, effective interventions to prevent and/or manage CRCC are elusive. Consequently, women seldom receive advice on how to prevent or manage CRCC. Aerobic exercise is associated with improved cognitive functioning in healthy older adults and adults with cognitive impairments. Accordingly, it holds promise as an intervention to prevent and/or manage CRCC. However, evidence from randomized controlled trials (RCTs) supporting a beneficial effect of aerobic exercise on CRCC is limited. The primary aim of the ACTIVATE trial is to evaluate the impact of supervised aerobic exercise on CRCC in women receiving chemotherapy for breast cancer.Methods: The ACTIVATE trial is a two-arm, two-centre RCT. Women diagnosed with stage I-III breast cancer and awaiting neo-adjuvant or adjuvant chemotherapy are recruited from hospitals in Ottawa (Ontario) and Vancouver (British Columbia), Canada. Recruits are randomized to the intervention group (aerobic exercise during chemotherapy) or the wait-list control group (usual care during chemotherapy and aerobic exercise post-chemotherapy). The primary outcome is cognitive functioning as measured by a composite cognitive summary score (COGSUM) of several neuropsychological tests. Secondary outcomes are self-reported cognitive functioning, quality of life, and brain structure and functioning (measured by magnetic resonance imaging (MRI)/functional MRI and electroencephalography). Assessments take place pre-chemotherapy (pre-intervention), mid-way through chemotherapy (mid-intervention/mid-wait period), end of chemotherapy (post-intervention/post-wait period; primary endpoint), 16-weeks post-chemotherapy, and at 1-year post-baseline.Discussion: Aerobic exercise is a promising intervention for preventing and/or managing CRCC and enhancing quality of life among women diagnosed with breast cancer. The ACTIVATE trial tests several novel hypotheses, including that aerobic exercise can prevent and/or mitigate CRCC and that this effect is mediated by the timing of intervention delivery (i.e., during versus post-chemotherapy). Findings may support prescribing exercise during (or post-) chemotherapy for breast cancer and elucidate the potential role of aerobic exercise as a management strategy for CRCC in women with early-stage breast cancer.Trial Registration: The trial was registered with the ClinicalTrials.gov database ( NCT03277898 ) on September 11, 2017. [ABSTRACT FROM AUTHOR]

Background: Self-management is becoming essential for breast cancer survivors, but evidence about the effectiveness of self-management support (SMS) intervention is lacking. To address this issue, we developed a theory-based SMS intervention, the 'EMPOWER', aimed at empowering breast cancer survivors. Here we describe the rationale of the intervention and its development.Methods: The conceptual framework of this study is the Chronic Care Model, which posits that SMS can influence patient-provider relationships and ultimately improve health outcomes. We will conduct a multi-center, 2-armed randomized controlled trial to assess the effectiveness of EMPOWER among post-treatment breast cancer survivors in South Korea. The trial will include 94 women who completed primary breast cancer treatment within the last 6 months. Participants will be randomly assigned to the intervention group or the wait-list control group (1:1). The intervention group will receive a 7-week partnership-based and needs-tailored SMS intervention via telephone counseling. The primary outcome is empowerment. The secondary outcomes include self-efficacy for post-treatment self-management behaviors, mental adjustment, psychological distress, and health-related quality of life (HRQOL). Data will be collected by self-reported questionnaire at baseline, post-intervention, and 3-month follow-up.Discussion: We believe that the EMPOWER intervention could improve HRQOL of post-treatment breast cancer survivors by enhancing their empowerment. If found successful, it could aid clinicians engaged in the long-term care of breast cancer survivors.Trial Registration: Clinical Research Information Service, KCT0004794. Registered 5 March 2020. [ABSTRACT FROM AUTHOR]

Background: The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.Objective: This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.Methods: The functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ).Results: The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F1,3=7.78, P=.001), Ex-SRES (F1,3=21.91, P<.001), and mMRC scores (F1,3=29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.Conclusions: The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.Trial Registration: Chinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3. [ABSTRACT FROM AUTHOR]

Background: The innovative treatment model Improving Access to Psychological Therapies (IAPT) and its Norwegian adaptation, Prompt Mental Health Care (PMHC), have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled.Objective: To investigate the effectiveness of the PMHC treatment compared to treatment as usual (TAU) at 6-month follow-up.Methods: A randomized controlled trial with parallel assignment was performed in two PMHC sites (Sandnes and Kristiansand) and enrolled clients between November 9, 2015 and August 31, 2017. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression (Patient Health Questionnaire [PHQ-9]/Generalized Anxiety Disorder scale [GAD-7] scores above cutoff). These were randomly assigned (70:30 ratio; n = 463 to PMHC, n = 218 to TAU) with simple randomization within each site with no further constraints. The main outcomes were recovery rates and changes in symptoms of depression (PHQ-9) and anxiety (GAD-7) between baseline and follow-up. Primary outcome data were available for 73/67% in PMHC/TAU. Sensitivity analyses based on observed patterns of missingness were also conducted. Secondary outcomes were work participation, functional status, health-related quality of life, and mental well-being.Results: A reliable recovery rate of 58.5% was observed in the PMHC group and of 31.9% in the TAU group, equaling a between-group effect size of 0.61 (95% CI 0.37 to 0.85, p < 0.001). The differences in degree of improvement between PMHC and TAU yielded an effect size of -0.88 (95% CI -1.23 to -0.43, p < 0.001) for PHQ-9 and -0.60 (95% CI -0.90 to -0.30, p < 0.001) for GAD-7 in favor of PMHC. All sensitivity analyses pointed in the same direction, with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69).Conclusions: The PMHC treatment was substantially more effective than TAU in alleviating the burden of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access to effective treatment for adults who suffer from anxiety and mild to moderate depression. A potential effect on work participation needs further examination. [ABSTRACT FROM AUTHOR]

Context: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated.Objectives: Does oxycodone reduce chronic breathlessness compared with placebo?Methods: A multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less doses/day) was available for both arms as required by one ethics committee overseeing the trial. Recruitment occurred from 2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology, and palliative care services across Australia. Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0-100 mm visual analogue scale) comparing arms Days 5-7. Secondary end points were average and worst breathlessness, quality of life, function, and harms.Results: Of 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P < 0.001).Conclusion: There was no signal of benefit from oxycodone over placebo. Future research should focus on investigating the existence of an opioid class effect on the reduction of chronic breathlessness. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy.Methods: Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later).Results: A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016).Conclusions: CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted. [ABSTRACT FROM AUTHOR]

Engaging in meaningful and enjoyable activities is an important contributor to well-being and maintaining good quality of life. There is a paucity of randomized controlled trials of interventions supporting people with mild dementia to engage in meaningful and purposeful activity. The aim of this study was to assess whether Behavioral Activation (BA) is an acceptable psychological intervention for people with mild dementia and whether a large-scale trial is feasible. Participants were randomly assigned to BA (n = 42) or treatment as usual (TAU) (n = 21). BA aimed at increasing engagement in enjoyable and meaningful activity, and preventing low mood. Follow-up was at 3 and 6 months. Assessors were blind to treatment allocation (trial registration number: ISRCTN75503960). Retention rate was above 80% at both assessment time points. Treatment acceptability and credibility were high. Depressive symptoms remained unchanged in both groups. There was evidence of improvement associated with BA for every day function (-3.92, 95% Confidence Interval (CI) -6.87 to -0.97), and engagement in meaningful and enjoyable activity (5.08, 95% CI 0.99 to 9.16) post-treatment (3 months) in comparison to TAU. Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months. Improvements in meaningful and enjoyable activity were maintained at 6 months.BA for people with mild dementia is feasible and acceptable and may be associated with clinically significant changes in function and quality of life. A full scale randomized controlled trial of clinical effectiveness is now needed. [ABSTRACT FROM AUTHOR]

Background: Although single-port laparoscopic cholecystectomy (SILC) is safe and effective, inherent surgeons' discomfort has prevented a large-scale adaptation of this technique. Recent advances in robotic technology suggest that da Vinci Single-Site™ cholecystectomy (dVSSC) may overcome this issue by reducing the stress load of the surgeon compared to SILC. However, evidence to objectively assess differences between the two approaches is lacking.Methods: 60 patients [36 women, 24 men (mean age 52 years)] with benign gallbladder disease were randomly assigned to dVSSC (n = 30) or SILC (n = 30) in this single-centre, single-blinded controlled trial. The primary endpoint was surgeon's stress load. Secondary endpoints included operating time, conversion rates, additional trocar placement, blood loss, length of hospital stay, procedure costs, health-related quality of life, cosmesis and complications. Data were collected preoperatively, during the hospital stay, and at 1 and 12 months' follow-up.Results: The dVSSC group showed a significant reduction of mental stress load of the surgeon compared to SILC [Subjective Mental Effort Questionnaire (SMEQ) score: median 25.0 (range 8-89) vs. 42.5 (range 13-110) points; p = 0.002] and a trend towards reduced physical stress load [Local Experienced Discomfort (LED) score: median 8 (range 2-27) vs. 12 (range 0-64) points; p = 0.088]. The length of hospital stay was longer in the SILC group [mean 3.06 (median 2; range 1-26) vs. 1.9 (median 2; range 1-4) days, p = 0.034] but overall hospital costs were higher for dVSSC [median 9734 (range 5775-16729) vs. 6900 (range 4156-99977) CHF; p = 0.001]. There were no differences in the rate of postoperative complications that required re-intervention (Dindo-Clavien grade ≥ IIIa; SILC n = 2 vs. dVSSC n = 0, p = 0.492) or other secondary endpoints.Conclusions: Da Vinci Single-Site™ cholecystectomy provides significant benefits over Single-Port Laparoscopic Cholecystectomy in terms of surgeon's stress load, matches the standards of the laparoscopic single-incision approach with regard to patients' outcomes but increases expenses. Clinicaltrials.gov registration-No.: NCT02485392. [ABSTRACT FROM AUTHOR]

Purpose: Head and neck cancer and its treatment deteriorate quality of life, but symptoms improve with person-centred care. We examined the cost-effectiveness of a person-centred care intervention versus standard medical care.Methods: In this randomized clinical trial of a person-centred intervention, patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1 year. Annual healthcare costs were identified from medical records and administrative register data. Productivity costs were calculated from reported sick leave. Health-related quality of life was collected using the EuroQol Group's five-dimension health state questionnaire.Results: Characteristics were similar between 53 patients in the intervention group and 39 control patients. The average total cost was Euro (EUR) 55,544 (95% confidence interval: EUR 48,474-62,614) in the intervention group and EUR 57,443 (EUR 48,607-66,279) among controls, with similar health-related quality of life.Conclusions: This person-centred intervention did not result in increased costs and dominated the standard medical care.Trial Registration: ClinicalTrials.gov (registration number: NCT02982746). [ABSTRACT FROM AUTHOR]

Purpose: Chronic pain, depression, and fatigue are common effects resulting from the cancer experience; new interventions are needed. This study examined the effect of Reimagine, an online symptom self-management curriculum that teaches coping skills, on key outcomes.Methods: Adult breast cancer survivors with chronic pain were recruited from the Army of Women volunteer registry for this randomized controlled trial and randomized 1:1 to Reimagine or usual care conditions. Electronic surveys collected demographic, clinical, and outcome data at baseline and 18 weeks post-intervention.Results: Participants (N = 89) were mean age 56.7 ± 8.7 years; 67% married; 58% employed; mean years since diagnosis 8.2 ± 6.6; and 89% were in remission or cured of their breast cancer. There was a significant difference in the change in depression scores for treatment (M = - 1.7, SD = 4.5) and usual care (M = 0.3, SD = 3.8) conditions; t(85) = - 2.3, p = .03. Difference in the change in fatigue scores was significant for treatment (M = 4.8, SD = 9.0) and usual care (M = 1.2, SD = 6.6) conditions; t(87) = 2.2, p = .03. Most Reimagine users (94%) would recommend the curriculum to others.Conclusions: These results suggest that Reimagine has an effect on depression and fatigue symptoms for breast cancer survivors. Online programs can be a feasible and effective alternative to in-person support. Additional research is recommended with larger and more diverse samples. [ABSTRACT FROM AUTHOR]

Objective: Bibliotherapy refers to psychological self-help interventions that utilize treatment books to improve psychological well-being. Research supports bibliotherapy as an efficacious intervention for a variety of mental health problems. Yet, few studies have investigated bibliotherapy in psychosocial oncology. The objective of this randomized controlled trial was to examine the efficacy of the NuCare intervention, delivered as a self-directed workbook, for enhancing empowerment, coping, and quality of life and reducing distress in patients with cancer.Methods: Eighty-nine adult patients with cancer were randomized to receive the workbook for 6 weeks or the control condition, usual care. Participants completed questionnaires at baseline, 6 weeks post-baseline, and 10 weeks post-baseline.Results: The increase of empowerment (main outcome) and quality of life and the decrease of distress in the NuCare group from pre-intervention to follow-up assessment differed significantly from the respective difference scores in the control group.Conclusions: The self-administered NuCare workbook is a potentially cost-effective, minimal intervention addressing psychosocial needs of patients with cancer.Practice Implications: Evidence-based bibliotherapy can empower patients and has the promise of reducing the burden on the healthcare system while enhancing the immediacy of psychosocial support. [ABSTRACT FROM AUTHOR]

Purpose: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.Methods: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment.Results: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.Conclusions: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.Trial Registration: JIVROSG-0402, JIVROSG-0807. [ABSTRACT FROM AUTHOR]

Background: Ischemic stroke has no approved treatments to enhance recovery. ALD-401 is an enriched population of aldehyde dehydrogenase-bright stem cells, capable of reducing neurological deficits in animal models. The primary objective of this trial was to determine the safety of internal carotid artery, intra-arterially delivered autologous bone marrow-derived ALD-401 in patients with disabling middle cerebral artery stroke in comparison with sham harvest with sham infusion. Secondary objectives were to determine feasibility and efficacy.Methods: This was a prospective phase 2, industry-funded, randomized, sham-controlled, parallel-group, multicenter study with blinded assessments. One hundred subjects were planned, aged 30 to 83 years, with confirmed first-time middle cerebral artery ischemic stroke with modified Rankin scale ≥3. Study patients were randomly assigned 3:2 to bone marrow harvest at 11 to 17 days after stroke followed 2 days later by intracarotid infusion of ALD-401 versus sham harvest and then sham infusion in the same timeframe. The primary study outcome was safety based on the incidence of a 4-point National Institutes of Health Stroke Scale worsening and the proportion of serious adverse events. Efficacy was based on modified Rankin scale change at 90 days. Other secondary outcomes were the proportions of patients experiencing adverse events, disability by Barthel Index, quality of life using EQ-5D, rehabilitation utilization, disability at 1 year, and MRI evidence of complications.Results: There were no infusional or allergic reactions and no difference in treatment emergent adverse events. Four patients had small areas of asymptomatic restricted diffusion on MRI in the treatment group. There was no significant difference between the ALD-401 and placebo groups on the modified Rankin scale for the intent-to-treat population at day 90 (mean difference, 0.3; 95% CI, -0.3 to 0.8; P=0.330). There were no significant differences between the groups on any of the secondary efficacy measures.Conclusions: Intracarotid infusion of ALD-401 does not lead to clinical adverse events in patients with subacute ischemic stroke, although there was a higher incidence of small lesions on MRI in the treatment group. There was no difference in the primary efficacy end point between the groups. The study provides a framework for the design and conduct of future intra-arterial cell therapy trials in stroke.Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01273337. [ABSTRACT FROM AUTHOR]

Objectives: We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts.Methods: We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17). Injections were administered 2 weeks before and 2 weeks after aspiration sclerotherapy. The primary endpoint was proportional cyst diameter reduction (%) from baseline to 6 weeks. Secondary outcomes included long-term cyst reduction at 26 weeks, patient-reported outcomes including the polycystic liver disease-questionnaire (PLD-Q) and safety.Results: Thirty-four patients (32 females; 53.6 ± 7.8 years) were randomized between pasireotide or placebo. Pasireotide did not improve efficacy of aspiration sclerotherapy at 6 weeks compared to controls (23.6 % [IQR 12.6-30.0] vs. 21.8 % [9.6-31.8]; p = 0.96). Long-term cyst diameter reduction was similar in both groups (49.1 % [27.0-73.6] and 45.6 % [29.6-59.6]; p = 0.90). Mean PLD-Q scores improved significantly in both groups (p < 0.01) without differences between arms (p = 0.92).Conclusions: In patients with large symptomatic hepatic cysts, complementary pasireotide to aspiration sclerotherapy did not improve cyst reduction or clinical response.Key Points: • Complementary pasireotide treatment does not improve efficacy of aspiration sclerotherapy. • Cyst fluid reaccumulation after aspiration sclerotherapy is a transient phenomenon. • Aspiration sclerotherapy strongly reduces symptoms and normalizes quality of life. [ABSTRACT FROM AUTHOR]

Introduction: Vitamin E is one of the most promising agents for nonalcoholic steatohepatitis (NASH) treatment, and its drug responsiveness may be closely associated with haptoglobin (Hp) genotype. However, its efficacy and safety remain unknown in China. This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH.Methods: VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in nondiabetic adults with NASH versus treatment with placebo in China. Liver biopsies are read by a pathological evaluation committee independently according to the NASH Clinical Research Network (CRN) scoring system. The NAFLD activity score (NAS) represents the sum of scores for steatosis, lobular inflammation, and hepatocyte ballooning. The definition of histologic improvement requires all three of the following criteria to be met: (a) either improvement in NAS by at least 2 points or post-treatment NAS score no higher than 3, (b) at least 1-point improvement in the score for ballooning, and (c) no worsening of fibrosis stages. We plan to recruit 120 biopsy-proven NASH patients from13 centers in China. Participants will be randomly assigned to groups treated with either with vitamin E (100 mg, tid) or placebo for 96 weeks then followed by 24 weeks of post-treatment observation. Biochemical parameters, cytokines, anthropometric parameters, CAP and TE values, Hp genotype, and several questionnaires will be collected as per the schedule. This protocol was approved by the Ethics Committee of Hangzhou Normal University Affiliated Hospital to ensure patients safety, and R&G Pharmastudies Co., Ltd. was established for monitoring the accumulated interim data to review efficacy and quality of data collection and overall study management.Results: As a preliminary study, a mobile phone application (app) for lifestyle modification and database recording ( http://laiyivens.365hy.com ) was exploited for every participant. The percentage of NAFLD patients with Hp 2-2 allele is much higher than that of Western patients (65.71% vs 36%, respectively), which suggests that the Chinese benefit more from vitamin E treatment.Conclusion: VENS is the first randomized controlled trial (RCT) to evaluate the efficacy of Vitamin E in treating nondiabetic NASH patients in China.Trial Registration: This study registered at https://clinicaltrials.gov (registration number: NCT02962297).Funding: Zhejiang Medicine Co., Ltd. [ABSTRACT FROM AUTHOR]

Context: Provision of home-based palliative care (PC) for seriously ill patients is important, yet few home-based PC services specifically or exclusively focus on end-stage heart failure (ESHF) patients.Objectives: This study aimed to examine the effect of a home-based palliative heart failure (HPHF) program on quality of life (QOL), symptoms burden, functional status, patient satisfaction, and caregiver burden among patients with ESHF.Methods: This study was a two-group randomized controlled trial undertaken in three hospitals. We recruited a total of 84 hospitalized ESHF patients who were referred to PC. They were randomized to the intervention or control group. The intervention group received a 12-week structured program with regular home visits/telephone calls provided by the nurse case managers. Data were collected at baseline (T1) and at four (T2) and 12 weeks (T3) after discharge.Results: A statistically significant between-group effect was found, with the HPHF group having significantly higher McGill QOL total score than the control group (P = 0.016) and there was significant group × time interaction effect (P = 0.032). There was no significant between-group effects detected for the measures of symptom distress or functional status at 12 weeks. The intervention group had higher satisfaction (P = 0.001) and lower caregiver burden (P = 0.024) than the control group at 12 weeks.Conclusion: The HPHF program is effective in enhancing the QOL of ESHF patients, satisfaction with care, and caregiver burden. The program has potential to reduce distress for some of the symptoms. [ABSTRACT FROM AUTHOR]

Background: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA.Methods: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed.Discussion: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective.Trial Registration: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016. [ABSTRACT FROM AUTHOR]

Background: In Parkinson's disease (PD) patients, fluctuations in symptoms commonly occur after many years of dopamine replacement therapy. The so-called wearing-off phenomenon exists of both motor and non-motor symptoms, such as rigidity and anxiety. Current treatment options are limited and an integrated approach is needed to address the complex interactions between motor and non-motor symptoms. Since wearing-off is eventually inevitable, treatment needs to focus on coping, acceptance and self-efficacy. We developed the body awareness training, named BEWARE, combining physical therapy with acceptance and commitment therapy to help PD patients deal better with wearing-off related anxiety (WRA).Methods: This was an investigator-blinded randomized controlled trial. Forty PD patients with WRA were randomly assigned to the BEWARE or to the treatment as usual (TAU) condition. Assessments were performed prior to and immediately after the treatment period, and at 3-months follow up. The primary outcome was self-efficacy, secondary outcomes focused on mobility, daily functioning, anxiety, depression and quality of life.Results: There was no significant improvement in self-efficacy in the BEWARE treatment condition when compared to TAU. However, standing balance and emotional wellbeing showed a significant improvement, and feelings of stigmatization showed a trend-significant decrease in the BEWARE condition.Conclusions: We consider the BEWARE training to be a promising therapeutic approach to address WRA. Improvement points from the participants included 1) less frequent but longer therapy sessions; 2) active involvement of caregivers; and 3) the development of a supportive workbook. The optimized treatment protocol needs further evaluation in a phase III RCT.Trial Registration: ClinicalTrials.gov identifier: NCT02054845. [ABSTRACT FROM AUTHOR]

Objective: Lung cancer patients report among the highest distress rates of all cancer patients. Partners report similar distress rates. The present study examined the effectiveness of additional mindfulness-based stress reduction (care as usual [CAU] + MBSR) versus solely CAU to reduce psychological distress in lung cancer patients and/or their partners.Methods: We performed a multicentre, parallel-group, randomized controlled trial. Mindfulness-based stress reduction is an 8-week group-based intervention, including mindfulness practice and teachings on stress. Care as usual included anticancer treatment, medical consultations, and supportive care. The primary outcome was psychological distress. Secondary outcomes included quality of life, caregiver burden, relationship satisfaction, mindfulness skills, self-compassion, rumination, and posttraumatic stress symptoms. Outcomes were assessed at baseline, post-intervention, and 3-month follow-up. Linear mixed modeling was conducted on an intention-to-treat sample. Moderation (gender, disease stage, baseline distress, participation with/without partner) and mediation analyses were performed.Results: A total of 31 patients and 21 partners were randomized to CAU + MBSR and 32 patients and 23 partners to CAU. After CAU + MBSR patients reported significantly less psychological distress (p = .008, d = .69) than after CAU. Baseline distress moderated outcome: those with more distress benefitted most from MBSR. Additionally, after CAU + MBSR patients showed more improvements in quality of life, mindfulness skills, self-compassion, and rumination than after CAU. In partners, no differences were found between groups.Conclusion: Our findings suggest that psychological distress in lung cancer patients can be effectively treated with MBSR. No effect was found in partners, possibly because they were more focused on patients' well-being rather than their own. [ABSTRACT FROM AUTHOR]

Background: Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).Methods: This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.Discussion: The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Trial Registration: Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016. [ABSTRACT FROM AUTHOR]

Background: Psychological distress is prevalent among people with Parkinson's disease (PD) and aggravates their motor symptoms, thereby leading to increased disability, high healthcare costs, and poor health-related quality of life (HRQoL). The under-recognition and adverse effects of the pharmacological management of anxiety and depression among the PD population are considerable. Thus, adopting a Complementary and Alternative Management (CAM) approach to address this problem is important. Yoga, one of the most common "mind-body" CAM therapies, can improve the psychological wellbeing of people with chronic illnesses. However, limited research on the effects of yoga in people with PD has been conducted. This study will determine the effects of yoga on the psychological wellbeing of people with mild-to-moderate PD and will compare these effects with those of stretching and resistance training exercises.Methods: A community-based, single-blind, randomized trial will be conducted. A total of 126 subjects will be recruited and randomly divided into yoga (n = 63) or stretching and resistance exercise (n = 63) groups. For 8 weeks, the yoga group will receive a weekly 90-min session of yoga, and the control group will receive a weekly 60-min session of stretching and resistance exercises. The primary outcome will be the level of psychological distress measured using the Hospital Anxiety and Depression Scale. The secondary outcomes will include the severity of motor symptoms measured by the Movement Disorders Society - Unified Parkinson's Disease Scale - Part III Motor Examination; mobility, balance, and fall risk measured by the Timed Up and Go test; spiritual wellbeing measured by the Holistic Wellbeing Scale; and HRQoL measured by the Parkinson's Disease Questionnaire-8. Assessment will be conducted at baseline, 8th, and 20th weeks of follow-ups.Discussion: This study will be the first randomized trial to compare the effect of yoga versus stretching and resistance training exercises in a PD population. Results will contribute to the value of yoga as a therapeutic option for managing psychological distress in PD patients. Multiple outcomes including psychological, physiological, and spiritual and HRQoL will also be measured to elucidate the potential mechanisms of yoga. The effect of yoga on people with chronic illnesses will further be elucidated. This information should contribute to future research, practice, and policy related to PD management.Trial Registration: WHO Primary Registry - Chinese Clinical Trials Registry (ChiCTR): CUHK_CCRB00522 Registered on 8 October 2016; date of approval 19 August 2016. [ABSTRACT FROM AUTHOR]

Background: Previous studies have shown that acupuncture is beneficial for the alleviation of chemotherapy-induced nausea and vomiting. However, there is a lack of clinical evidence concerning the effects of acupoint-matching on chemotherapy-induced nausea and vomiting.Methods/design: This is a parallel randomized controlled trial to evaluate the occurrence of nausea and vomiting after chemotherapy (the incidence of nausea and vomiting, frequency, VAS score, RINVR rating) as the main outcome for cancer. Quality of life, anxiety and depression scores are the secondary outcomes. Quality of life, anxiety and depression scores are the secondary phase. Use of remedy drugs, routine blood examination, and blood biochemical tests are the safety evaluation. We also compare the different effects of ST36 (single acupoint), CV12 (single acupoint), and ST36-CV12 matching groups.Discussion: The results of this trial are expected to explore the effects of matching different acupoints and to offer biologic plausibility for the use of acupuncture in the treatment of chemotherapy-induced nausea and vomiting (CINV).Trial Registration: This trial is registered with clinicaltrials.gov NCT02195921 , The date of registration was 17 July 2014. [ABSTRACT FROM AUTHOR]

Background: Low back pain is a debilitating condition for older adults, who may seek healthcare from multiple providers. Few studies have evaluated impacts of different healthcare delivery models on back pain outcomes in this population. The purpose of this study was to compare clinical outcomes of older adults receiving back pain treatment under 3 professional practice models that included primary medical care with or without chiropractic care.Methods: We conducted a pilot randomized controlled trial with 131 community-dwelling, ambulatory older adults with subacute or chronic low back pain. Participants were randomly allocated to 12 weeks of individualized primary medical care (Medical Care), concurrent medical and chiropractic care (Dual Care), or medical and chiropractic care with enhanced interprofessional collaboration (Shared Care). Primary outcomes were low back pain intensity rated on the numerical rating scale and back-related disability measured with the Roland-Morris Disability Questionnaire. Secondary outcomes included clinical measures, adverse events, and patient satisfaction. Statistical analyses included mixed-effects regression models and general estimating equations.Results: At 12 weeks, participants in all three treatment groups reported improvements in mean average low back pain intensity [Shared Care: 1.8; 95% confidence interval (CI) 1.0 to 2.6; Dual Care: 3.0; 95% CI 2.3 to 3.8; Medical Care: 2.3; 95% CI 1.5 to 3.2)] and back-related disability (Shared Care: 2.8; 95% CI 1.6 to 4.0; Dual Care: 2.5; 95% CI 1.3 to 3.7; Medical Care: 1.5; 95% CI 0.2 to 2.8). No statistically significant differences were noted between the three groups on the primary measures. Participants in both models that included chiropractic reported significantly better perceived low back pain improvement, overall health and quality of life, and greater satisfaction with healthcare services than patients who received medical care alone.Conclusions: Professional practice models that included primary care and chiropractic care led to modest improvements in low back pain intensity and disability for older adults, with chiropractic-inclusive models resulting in better perceived improvement and patient satisfaction over the primary care model alone.Trial Registration: Clinicaltrials.gov, NCT01312233 , 4 March 2011. [ABSTRACT FROM AUTHOR]

Background: Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU).Methods: The authors conducted a parallel-group randomized controlled trial. Severely fatigued, disease-free survivors of breast cancer who had completed cancer treatment at least 3 months previously were eligible. Participants were randomly allocated to ICBT or CAU using computer-generated stratified block randomization. The primary outcome of fatigue severity was assessed at baseline and after 6 months, as were the secondary outcomes of functional impairment, psychological distress, and quality of life. Statistical effects were tested with analyses of covariance (intention-to-treat analysis).Results: Participants were recruited between January 2014 and March 2016 and assigned to ICBT (66 patients) or CAU (66 patients). Compared with the participants who had received CAU, those who had received ICBT reported lower fatigue scores at 6 months (mean difference [Δ], 11.5; 95% confidence interval [95% CI], 7.7-15.3) and a large effect size (Cohen d = 1.0), with the majority of patients (73%) demonstrating clinically significant improvement. ICBT also was found to lead to lower functional impairment (Δ, 297.8; 95% CI, 145.5-450.1) and psychological distress scores (Δ, 5.7; 95% CI, 3.4-7.9) and higher quality-of-life scores (Δ, 11.7; 95% CI, 5.8-17.7) compared with CAU, with medium to large effect sizes (Cohen d = 0.6-0.8).Conclusions: ICBT appears to be effective in reducing severe fatigue and related symptoms and meets the current need for easy accessible and more efficient evidence-based treatment options for severely fatigued survivors of breast cancer. Cancer 2017;123:3825-34. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: Research is yet to investigate whether psychological interventions delivered early after diagnosis can benefit patients with head and neck cancer (HNC).Purpose: The aim of this study was to investigate the effectiveness of a brief self-regulatory intervention (targeting illness perceptions and coping) at improving HNC patient health-related quality of life (HRQL).Methods: A pilot randomized controlled trial was conducted, in which 64 patients were assigned to receive three sessions with a health psychologist in addition to standard care or standard care alone. Participants completed questionnaires assessing HRQL, general distress, and illness perceptions at baseline and again 3 and 6 months later.Results: Compared to the control group, patients who received the intervention had increased treatment control perceptions at 3 months (p = .01), and increased social quality of life at 6 months (p = .01). The intervention was particularly helpful for patients exhibiting distress at baseline.Conclusion: A brief psychological intervention following HNC diagnosis can improve patient perceptions of treatment and social quality of life over time. Such interventions could be targeted to patients who are distressed in order to confer the greatest benefit.Trial Registration Number: 12614000813684. [ABSTRACT FROM AUTHOR]

Background: Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.Methods: The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.Discussion: This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial Registration: Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1. [ABSTRACT FROM AUTHOR]

Background: Patients with Parkinson's disease exhibit disturbed manual dexterity. This impairment leads to difficulties in activities of daily living, such as buttoning a shirt or hand-writing. The aim of the present study was to investigate the effectiveness of a home-based dexterity program on fine motor skills in a single-blinded, randomized controlled trial, in patients with Parkinson's disease.Methods: One hundred and three patients with Parkinson's disease (aged between 48 and 80 years, Hoehn & Yahr stage I-IV) were randomized to either a home-based dexterity program (HOMEDEXT) or Thera-band program. All patients trained over a period of 4 weeks, 5 times/week, 30 min for each session. A baseline, post-intervention, and follow-up assessment (12 weeks later, time period without intervention) were done. The primary outcome measure was dexterity as measured with the Nine Hole peg test (9-HPT). Secondary outcome measures included strength, motor parkinsonian symptoms, dexterity-related activities of daily living (ADL) and Health-related Quality of Life (HrQoL).Results: There was a significant difference in favor of the HOMEDEXT group as compared to the Thera-band group on the primary outcome 9-HPT (p = 0.006) and dexterity-related ADL (p = 0.02) at post intervention. No significant differences were found for the other outcomes, nor at follow-up.Conclusion: This is the first randomized controlled trial showing that an intensive, task specific home-based dexterity program significantly improved fine motor skills in Parkinson's disease. The effect generalized to dexterity-related ADL functions. As these improvements did not sustain, the finding suggest that continuous training is required to maintain the benefit. [ABSTRACT FROM AUTHOR]

Background: Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months' time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care.Methods: The Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group.Discussion: To our knowledge, this is the first depressive symptom stratification tool designed for primary care which takes a prognosis-based approach to provide a tailored treatment recommendation. If shown to be effective, this tool could be used to assist general practitioners to implement stepped mental-healthcare models and contribute to a more efficient and effective mental health system.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR 12616000537459 ). Retrospectively registered on 27 April 2016. See Additional file 1 for trial registration data. [ABSTRACT FROM AUTHOR]

Background: Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to improve the cognition of community living elderly with mild cognitive impairment.Methods/design: This open-label, interventional study involves a parallel randomized controlled trial design with three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based randomization system. Interventions will be provided by trained staff with a control group not receiving any intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated measurements and further analysis may be undertaken to adjust for potential confounders.Discussion: This will be the first study to compare the effectiveness of art therapy and music reminiscence activity in a randomized controlled trial. We expect that the trial will provide useful evidence for developing psychosocial interventions for the elderly with mild cognitive impairment.Trial Registration: The study was registered on 7 July 2016 at Clinical Trials.gov, a service of the US National Institute of Health ( NCT02854085 ), retrospectively. [ABSTRACT FROM AUTHOR]

Background: Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life.Methods: We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2). In control clinics, women received screening and a referral card from nurses. Surveys were conducted at T1, T2, and T3 (15 months from baseline). Our main outcome was past-year physical and sexual IPV. Intent-to-treat analyses were conducted via three-level random intercepts models to evaluate the interaction term for treatment status by time.Results: Between April and October 2013, 950 women (480 in control clinics, 470 in treatment clinics) with recent IPV experiences enrolled in the study. While reductions in IPV were observed for both women enrolled in treatment (OR, 0.40; 95% CI, 0.28-0.55; P < 0.01) and control (OR, 0.51; 95% CI, 0.36-0.72; P < 0.01) clinics at T3 (July to December 2014), no significant treatment effects were observed (OR, 0.78; 95% CI, 0.49-1.24; P = 0.30). At T2 (July to December 2013), women in treatment clinics reported significant improvements, compared to women in control clinics, in mental quality of life (β, 1.45; 95% CI, 0.14-2.75; P = 0.03) and safety planning behaviors (β, 0.41; 95% CI, 0.02-0.79; P = 0.04).Conclusion: While reductions in IPV levels were seen among women in both treatment and control clinics, the enhanced nurse intervention was no more effective in reducing IPV. The enhanced nursing intervention may offer short-term improvements in addressing safety planning and mental quality of life. Nurses can play a supportive role in assisting women with IPV experiences.Trial Registration: Clinicaltrials.gov ( NCT01661504 ). Registration Date: August 2, 2012. [ABSTRACT FROM AUTHOR]

Background: Family caregivers (FC) often experience higher distress levels than their relative with cancer. Many cancer centers have implemented distress screening programs, but most of them concentrate their efforts on patients, with little attention to their FC. To fill this gap, a pragmatic intervention has been designed to improve supportive care for FC of patients with lung cancer. This article describes the study protocol of a single-center randomized controlled trial to assess its effectiveness.Methods/design: A total of 120 lung cancer patients and their FC are randomly assigned to the experimental group (exposed to intervention, N = 60) or to the control group (usual care, N = 60). The intervention includes: (1) systematic FC distress screening and problem assessment near their relative's cancer diagnosis, and every 2 months, (2) privileged contact with an oncology nurse (ON) away from the patient to address FC problems and (3) liaison by the ON with the family physician of FC reporting high distress (thermometer score ≥5/10), or problems relying on FP expertise. In both groups, FC, patient and process-of-care outcomes are measured at baseline and every 3 months, up to 9 months. The primary endpoint is FC distress measured by the Hospital Anxiety and Depression Scale (HADS) and the Psychological Distress Index used in the Quebec Health Survey (PDQHS). Individual interviews with 10 FC and a focus group with the oncology team will be conducted at the study end to further document the effectiveness of the intervention and its impact on quality of life (for FC) and practice organization (for the oncology team).Discussion: This trial will assess the effectiveness of an innovative intervention based on interprofessional collaboration between primary care and oncology care. It targets a population in great need, yet often neglected, and has the potential to clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.Trial Registration: ClinicalTrials.gov, ID: NCT02531464 . Registered on 15 July 2015. [ABSTRACT FROM AUTHOR]

Background: Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC).Methods: This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727).Results: The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups.Conclusions: In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC. [ABSTRACT FROM AUTHOR]

Background: A text messaging service (short message service [SMS]) has the potential to target large groups of people with long-term illnesses such as serious mental disorders, who may have difficulty with treatment adherence. Robust research on the impact of mobile technology interventions for these patients remains scarce.Objective: The main objective of our study was to investigate the impact of individually tailored short text messages on the rate of psychiatric hospital readmissions, health care service use, and clinical outcomes. In addition, we analyzed treatment costs.Methods: Between September 2011 and November 2012, we randomly assigned 1139 people to a tailored text message intervention (n=569) or usual care (n=570). Participants received semiautomated text messages for up to 12 months or usual care. The primary outcome, based on routinely collected health register data, was patient readmission into a psychiatric hospital during a 12-month follow-up period. Secondary outcomes were related to other service use, coercion, medication, adverse events, satisfaction, social functioning, quality of life, and economic factors (cost analysis).Results: There was 98.24% (1119/1139) follow-up at 12 months. Tailored mobile telephone text messages did not reduce the rate of hospital admissions (242/563, 43.0% of the SMS group vs 216/556, 38.8% of the control group; relative risk 1.11; 95% CI 0.92-1.33; P=.28), time between hospitalizations (mean difference 7.0 days 95% CI -8.0 to 24.0; P=.37), time spent in a psychiatric hospital during the year (mean difference 2.0 days 95% CI -2.0 to 7.0; P=.35), or other service outcomes. People who received text messages were less disabled, based on Global Assessment Scale scores at the time of their readmission, than those who did not receive text messages (odds ratio 0.68; 95% CI 0.47-0.97; P=.04). The costs of treatment were higher for people in the SMS group than in the control group (mean €10,103 vs €9210, respectively, P<.001).Conclusions: High-grade routinely collected data can provide clear outcomes for pragmatic randomized trials. SMS messaging tailored with the input of each individual patient did not decrease the rate of psychiatric hospital visits after the 12 months of follow-up. Although there may have been other, more subtle effects, the results of these were not evident in outcomes of agreed importance to clinicians, policymakers, and patients and their families.Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6rVzZrbuz). [ABSTRACT FROM AUTHOR]

Background: For some stroke patients and caregivers, navigating the transition between hospital discharge and returning home is associated with substantial psychosocial and health-related challenges. Currently, no evidence-based standard of care exists that addresses the concerns of stroke patients and caregivers during the transition period. Objectives of the Michigan Stroke Transitions Trial (MISTT) are to test the impact of a social worker home-based case management program, as well as an online information and support resource, on patient and caregiver outcomes after returning home.Methods: The Michigan Stroke Transitions Trial is a randomized, pragmatic, open (un-blinded), 3-group parallel designed superiority trial conducted in 3 Michigan hospitals. Eligible participants are adult acute stroke patients discharged home directly or within 4 weeks of being discharged to a rehabilitation facility. The patient's primary caregiver is also invited to participate. Patients are randomized on the day they return home using a randomized block design. Consented patients discharged to a rehabilitation facility who do not go home within 4 weeks are dropped from the study. The 2 study interventions begin within a week of returning home and conclude 3 months later. The 3-group design compares usual care to either a home-based social worker stroke case management (SWSCM) program, or a combination of the SWSCM program plus access to an online information and support resource (MISTT website). Outcomes data are collected at 7-days and 90-days by trained telephone interviewers. Primary patient outcomes include the PROMIS global 10 score (a generic Quality of Life scale), and the Patient Activation Measure (PAM). Caregiver outcomes include the Bakas Caregiving Outcomes Scale. Final analysis will be based on 214 randomized acute stroke patients. To accommodate subjects excluded due to prolonged rehabilitation stays, as well as those lost-to-follow-up, up to 315 patients will be consented.Discussion: The MISTT study will determine if a home-based case management program designed around the needs and preferences of stroke patients and caregivers, alone or in combination with a patient-centered online information and support resource can improve stroke survivor and caregiver outcomes 3 months after returning home.Trial Registration: ClinicalTrials.gov: NCT02653170 (Protocol ID: 135457). Registered April 9, 2015. [ABSTRACT FROM AUTHOR]