Does nature-based social prescription improve mental health outcomes? A systematic review and meta-analysis.

Background: A nature-based social prescription (NBSP) is an approach to improving mental health outcomes that involves prescribing nature-based interventions as complementary or alternative therapy to traditional ones. A variety of advantages are available from NBSP for people looking to enhance their mental well-being. The effect size of the nature-based social prescriptions (NBSPs) has not been thoroughly evaluated by systematic reviews and meta-analyses. Objectives: The current study aimed to analyze existing studies and conduct a meta-analysis to determine the overall effect size of the nature-based social prescriptions (NBSP's) outcomes on mental health. Methods: By choosing the relevant papers from among those that were available, a meta-analysis was carried out in the current study. A systematic search of electronic databases (Pub Med, Web of Science, Scopus, Cochrane Library, Embase, CINAHL, and PsychINFO) was conducted to identify relevant studies. Studies were included if they evaluated the effects of NBSP on mental health outcomes. Effect sizes were calculated using the random effects model. Results: Meta-analysis of interventions statistics shows that CBT (SMD -0.0035; 95% CI: [-0.5090; 0.5020]; Tau^2: 0.1011; Tau: 0.318), digital intervention (SMD -0.3654; 95% CI: [-0.5258; 1.2566]; Tau^2: 0.2976, Tau: 0.5455), music intervention (SMD -2.1281; 95% CI: [-0.4659; 4.7221]; Tau^2: 3.4046; Tau:1.8452), and psychological interventions (SMD -0.8529; 95% CI: [0.3051; 1.4007]; Tau^2: 0.1224; Tau: 0.3499) do not significantly impact. The other interventions [social belongingness, communication training, blue intervention, nature-based education, cognitive behavior group therapy (CBGT), social prescribing coordinator, self-help intervention, participatory, organizational intervention, inpatient services, brief diet, internet-based intervention, prenatal intervention, yoga and meditation, ergonomics training program, yoga nidra intervention, and storytelling] highlighted above are significant. Conclusion: The conclusion of the meta-analysis supports the idea that incorporating nature-based social prescription interventions into mental healthcare plans can effectively complement traditional therapies and improve mental health outcomes. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023412458, CRD42023412458.

Acute spinal cord injury serum biomarkers in human and rat: a scoping systematic review.

STUDY DESIGN: Scoping systematic review. OBJECTIVES: To summarize the available experimental clinical and animal studies for the identification of all CSF and serum-derived biochemical markers in human and rat SCI models. SETTING: Tehran, Iran. METHODS: In this scoping article, we systematically reviewed the electronic databases of PubMed, Scopus, WOS, and CENTRAL to retrieve current literature assessing the levels of different biomarkers in human and rat SCI models. RESULTS: A total of 19,589 articles were retrieved and 6897 duplicated titles were removed. The remaining 12,692 studies were screened by their title/abstract and 12,636 were removed. The remaining 56 were considered for full-text assessment, and 11 papers did not meet the criteria, and finally, 45 studies were included. 26 studies were human observational studies comprising 1630 patients, and 19 articles studied SCI models in rats, including 832 rats. Upon reviewing the literature, we encountered a remarkable heterogeneity in terms of selected biomarkers, timing, and method of measurement, studied models, extent, and mechanism of injury as well as outcome assessment measures. CONCLUSIONS: The specific expression and distribution patterns of biomarkers in relation to spinal cord injury (SCI) phases, and their varied concentrations over time, suggest that cerebrospinal fluid (CSF) and blood biomarkers are effective measures for assessing the severity of SCI.

Malnutrition-Related Health Outcomes in Older Adults with Hip Fractures: A Systematic Review and Meta-Analysis.

Hip fracture is a common condition in older adults, leading to disability and mortality. Several studies have demonstrated the association between nutritional status and the risk of a negative health outcome after fractures. In this systematic review, we evaluated the association between malnutrition and mortality, changes in mobility/living arrangements, and postoperative complications, such as delirium, in older patients with hip fractures. A literature search on the PubMed, Web of Science, and Scopus databases, up to September 2023, was conducted to identify all studies involving older subjects that reported an association between MNA/GNRI/PNI/CONUT and health outcome after hip fracture. Meta-analysis was performed by a random-effects model using risk values (RR, OR, and HR) extracted from the 14 eligible selected studies. Malnutrition significantly increased the risk of any analyzed adverse outcome by 70% at 1 month, and up to 250% at 1 year. Malnutrition significantly increased delirium risk by 275% (OR = 2.75; 95% CI 1.80-4.18; p ≤ 0.05), mortality risk by 342% (OR = 3.42; 95% CI 2.14-5.48; p ≤ 0.05), mortality hazard risk by 351% (HR = 3.51; 95% CI 1.63-7.55; p ≤ 0.05) at 1 month, and transfer-to-more-supported-living-arrangements risk by 218% (OR = 2.18; 95% CI 1.58-3.01; p ≤ 0.05), and declined mobility risk by 41% (OR = 1.41; 95% CI 1.14-1.75; p ≤ 0.05), mortality risk by 368% (OR = 3.68; 95% CI 3.00-4.52; p ≤ 0.05), and mortality hazard risk by 234% (HR = 2.34; 95% CI 1.91-2.87; p ≤ 0.05) at 1 year. Malnutrition of older patients increases the risk of death and worsens mobility and independence after hip fractures. The results of the present study highlight the importance of nutritional status evaluation of older subjects with hip fractures in order to prevent potential adverse outcomes (Registration No: CRD42023468751).

Predictors of Mental Health Outcomes in a Multidisciplinary Weight Management Program for Class 3 Obesity.

This study aimed to examine the potential predictors of improvement in mental health outcomes following participation in an intensive non-surgical outpatient weight management program (WMP) in an Australian public hospital. This was a retrospective cohort study of all adults with Class 3 obesity (BMI ≥ 40 kg/m2) who enrolled in the WMP from March 2018 to June 2021. The participants completed the Eating Disorder Examination Questionnaire Short Version (EDE-QS), Kessler-10 Psychological Distress Scale, and 36-Item Short-Form Survey (SF-36) at baseline and 12-month follow-up. A total of 115 patients completed 12 months in the WMP and were included in the study, with 76.5% being female, a mean ± SD age at baseline of 51.3 ± 13.8 years, a weight of 146 ± 26 kg, and a BMI of 51.1 ± 8.6 kg/m2. The participants lost an average of 8.6 ± 0.2 kg over 12 months, and greater weight loss at follow-up was significantly associated with improved global EDE-QS scores, psychological distress, and improved mental health quality of life. However, improvements in most mental health outcomes were not predicted by weight loss alone. Notably, a lower eating disorder risk at baseline was associated with less psychological distress at follow-up and greater weight loss at follow-up. Our results also found an association between reduced psychological distress and reduced binge eating frequency. These findings support the inclusion components of obesity interventions that target the psychological correlates of obesity to support improved outcomes in people with Class 3 obesity. Future studies should aim to identify which aspects of the WMP helped improve people's psychological outcomes.

Age-related differences in the impact of resilience on mental health outcomes during the COVID-19 pandemic in Hong Kong.

OBJECTIVE: This study investigated changes in mental health in Hong Kong over two years and examined the role of resilience and age in mitigating the negative effects of public health emergencies, particularly the COVID-19 pandemic. METHODS: Complete data of interest from two telephone surveys conducted in 2020 (n = 1182) and 2021 (n = 1108) were analysed. Participants self-reported depressive and anxiety symptoms using the Patient Health Questionnaire 4-item version (PHQ), psychotic-like experiences (PLEs) using three items from the Prodromal Questionnaire Brief (PQB), and resilience using the Connor-Davidson Resilience Scale 2-item version (CD-RISC-2). RESULTS: We observed an increase in the percentage of participants with high depressive and anxiety symptoms and PLEs from 1.6% to 6.5% between 2020 and 2021. The likelihood of having high depressive and anxiety symptoms or PLEs depended on resilience and age, with no significant between-year differences. Resilience and age interaction effects were significant when comparing the high PHQ-high PQB group to the low PHQ-low PQB group only in 2021 but not in 2020. CONCLUSIONS: This study provides valuable insights into the impact of the COVID-19 pandemic on mental health in Hong Kong, emphasising the age-dependent nature of resilience in mitigating negative effects. Future research should explore the mechanisms by which resilience promotes mental health and well-being and identify ways to enhance resilience among older individuals during public health crises.

Key lifestyles and health outcomes across 16 prevalent chronic diseases: A network analysis of an international observational study.

Background: Central and bridge nodes can drive significant overall improvements within their respective networks. We aimed to identify them in 16 prevalent chronic diseases during the coronavirus disease 2019 (COVID-19) pandemic to guide effective intervention strategies and appropriate resource allocation for most significant holistic lifestyle and health improvements. Methods: We surveyed 16 512 adults from July 2020 to August 2021 in 30 territories. Participants self-reported their medical histories and the perceived impact of COVID-19 on 18 lifestyle factors and 13 health outcomes. For each disease subgroup, we generated lifestyle, health outcome, and bridge networks. Variables with the highest centrality indices in each were identified central or bridge. We validated these networks using nonparametric and case-dropping subset bootstrapping and confirmed central and bridge variables' significantly higher indices through a centrality difference test. Findings: Among the 48 networks, 44 were validated (all correlation-stability coefficients >0.25). Six central lifestyle factors were identified: less consumption of snacks (for the chronic disease: anxiety), less sugary drinks (cancer, gastric ulcer, hypertension, insomnia, and pre-diabetes), less smoking tobacco (chronic obstructive pulmonary disease), frequency of exercise (depression and fatty liver disease), duration of exercise (irritable bowel syndrome), and overall amount of exercise (autoimmune disease, diabetes, eczema, heart attack, and high cholesterol). Two central health outcomes emerged: less emotional distress (chronic obstructive pulmonary disease, eczema, fatty liver disease, gastric ulcer, heart attack, high cholesterol, hypertension, insomnia, and pre-diabetes) and quality of life (anxiety, autoimmune disease, cancer, depression, diabetes, and irritable bowel syndrome). Four bridge lifestyles were identified: consumption of fruits and vegetables (diabetes, high cholesterol, hypertension, and insomnia), less duration of sitting (eczema, fatty liver disease, and heart attack), frequency of exercise (autoimmune disease, depression, and heart attack), and overall amount of exercise (anxiety, gastric ulcer, and insomnia). The centrality difference test showed the central and bridge variables had significantly higher centrality indices than others in their networks (P < 0.05). Conclusion: To effectively manage chronic diseases during the COVID-19 pandemic, enhanced interventions and optimised resource allocation toward central lifestyle factors, health outcomes, and bridge lifestyles are paramount. The key variables shared across chronic diseases emphasise the importance of coordinated intervention strategies.

A Novel Blended Transdiagnostic Intervention (eOrygen) for Youth Psychosis and Borderline Personality Disorder: Uncontrolled Single-Group Pilot Study.

BACKGROUND: Integrating innovative digital mental health interventions within specialist services is a promising strategy to address the shortcomings of both face-to-face and web-based mental health services. However, despite young people's preferences and calls for integration of these services, current mental health services rarely offer blended models of care. OBJECTIVE: This pilot study tested an integrated digital and face-to-face transdiagnostic intervention (eOrygen) as a blended model of care for youth psychosis and borderline personality disorder. The primary aim was to evaluate the feasibility, acceptability, and safety of eOrygen. The secondary aim was to assess pre-post changes in key clinical and psychosocial outcomes. An exploratory aim was to explore the barriers and facilitators identified by young people and clinicians in implementing a blended model of care into practice. METHODS: A total of 33 young people (aged 15-25 years) and 18 clinicians were recruited over 4 months from two youth mental health services in Melbourne, Victoria, Australia: (1) the Early Psychosis Prevention and Intervention Centre, an early intervention service for first-episode psychosis; and (2) the Helping Young People Early Clinic, an early intervention service for borderline personality disorder. The feasibility, acceptability, and safety of eOrygen were evaluated via an uncontrolled single-group study. Repeated measures 2-tailed t tests assessed changes in clinical and psychosocial outcomes between before and after the intervention (3 months). Eight semistructured qualitative interviews were conducted with the young people, and 3 focus groups, attended by 15 (83%) of the 18 clinicians, were conducted after the intervention. RESULTS: eOrygen was found to be feasible, acceptable, and safe. Feasibility was established owing to a low refusal rate of 25% (15/59) and by exceeding our goal of young people recruited to the study per clinician. Acceptability was established because 93% (22/24) of the young people reported that they would recommend eOrygen to others, and safety was established because no adverse events or unlawful entries were recorded and there were no worsening of clinical and social outcome measures. Interviews with the young people identified facilitators to engagement such as peer support and personalized therapy content, as well as barriers such as low motivation, social anxiety, and privacy concerns. The clinician focus groups identified evidence-based content as an implementation facilitator, whereas a lack of familiarity with the platform was identified as a barrier owing to clinicians' competing priorities, such as concerns related to risk and handling acute presentations, as well as the challenge of being understaffed. CONCLUSIONS: eOrygen as a blended transdiagnostic intervention has the potential to increase therapeutic continuity, engagement, alliance, and intensity. Future research will need to establish the effectiveness of blended models of care for young people with complex mental health conditions and determine how to optimize the implementation of such models into specialized services.

Cross-cultural adaptation and psychometric validation of point-of-care outcome assessment tools in Chinese palliative care clinical practice.

BACKGROUND: A standardized national approach to routinely assessing palliative care patients helps improve patient outcomes. However, a quality improvement program-based on person centered outcomes within palliative care is lacking in Mainland China. The well-established Australian Palliative Care Outcome Collaboration (PCOC) national model improves palliative care quality. This study aimed to culturally adapt and validate three measures that form part of the PCOC program for palliative care clinical practice in China: The PCOC Symptom Assessment Scale (PCOC SAS), Palliative Care Problem Severity Scale (PCPSS), Palliative Care Phase. METHODS: A study was conducted on cross-cultural adaptation and validation of PCOC SAS, PCPSS and Palliative Care Phase, involving translation methods, cognitive interviewing, and psychometric testing through paired assessments. RESULTS: Cross-cultural adaptation highlighted the need to strengthen the link between the patient's care plan and the outcome measures to improve outcomes, and the concept of distress in PCOC SAS. Analysis of 368 paired assessments (n = 135 inpatients, 22 clinicians) demonstrated that the PCOC SAS and PCPSS had good and acceptable coherence (Cronbach's a = 0.85, 0.75 respectively). Palliative Care Phase detected patients' urgent needs. PCOC SAS and PCPSS showed fair discriminant and concurrent validity. Inter-rater reliability was fair for Palliative Care Phase (k = 0.31) and PCPSS (k = 0.23-0.30), except for PCPSS-pain, which was moderate (k = 0.53). CONCLUSIONS: The Chinese version of PCOC SAS, PCPSS, and Palliative Care Phase can be used to assess outcomes as part of routine clinical practice in Mainland China. Comprehensive clinical education regarding the assessment tools is necessary to help improve the inter-rater reliability.

The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: Digital health definitions are abundant, but often lack clarity and precision. We aimed to develop a minimum information framework to define patient-facing digital health interventions (DHIs) for outcomes research. METHODS: Definitions of digital-health-related terms (DHTs) were systematically reviewed, followed by a content analysis using frameworks, including PICOTS (population, intervention, comparator, outcome, timing, and setting), Shannon-Weaver Model of Communication, Agency for Healthcare Research and Quality Measures, and the World Health Organization's Classification of Digital Health Interventions. Subsequently, we conducted an online Delphi study to establish a minimum information framework, which was pilot tested by 5 experts using hypothetical examples. RESULTS: After screening 2610 records and 545 full-text articles, we identified 101 unique definitions of 67 secondary DHTs in 76 articles, resulting in 95 different patterns of concepts among the definitions. World Health Organization system (84.5%), message (75.7%), intervention (58.3%), and technology (52.4%) were the most frequently covered concepts. For the Delphi survey, we invited 47 members of the ISPOR Digital Health Special Interest Group, 18 of whom became the Delphi panel. The first, second, and third survey rounds were completed by 18, 11, and 10 respondents, respectively. After consolidating results, the PICOTS-ComTeC acronym emerged, involving 9 domains (population, intervention, comparator, outcome, timing, setting, communication, technology, and context) and 32 optional subcategories. CONCLUSIONS: Patient-facing DHIs can be specified using PICOTS-ComTeC that facilitates identification of appropriate interventions and comparators for a given decision. PICOTS-ComTeC is a flexible and versatile tool, intended to assist authors in designing and reporting primary studies and evidence syntheses, yielding actionable results for clinicians and other decision makers.

National Hospital Care Survey Demonstration Projects: Examination of Maternal Health Outcomes by Housing Assistance Status.

Objectives-Objective-This report demonstrates the use of linked National Hospital Care Survey (NHCS) and U.S. Department of Housing and Urban Development (HUD) administrative data to examine demographic characteristics and maternal health outcomes among both patients who received and did not receive housing assistance. Methods-Administrative claims data and electronic health records data from the 2016 NHCS were linked to 2015-2017 HUD administrative data using patient identifiers. HUD administrative data for Housing Choice Voucher, Public Housing, and Multifamily housing program participation were used to identify patients who received housing assistance before, during, or after their delivery hospitalization. Exploratory analyses were conducted for patients who had a delivery hospitalization in 2016 and were eligible for linkage to HUD administrative data. Demographic characteristics and maternal health outcomes were compared by housing assistance status. The linked NHCS-HUD data are unweighted and not nationally representative. Results-In the 2016 NHCS, 146,672 patients had a delivery hospitalization and were eligible for linkage to 2015-2017 HUD administrative data (95.6% had a live birth, 1.0% had a stillbirth, and 3.4% were unspecified). Among this study population, 9,559 patients (6.5%) received housing assistance from 2015 to 2017. Among those who received housing assistance, 66.5% visited large metropolitan hospitals, 71.8% were insured by Medicaid, and 3.0% experienced severe maternal morbidity. Among patients who did not receive housing assistance, 74.0% visited large metropolitan hospitals, 35.6% were insured by Medicaid, and 1.9% experienced severe maternal morbidity. Nearly two-thirds of patients who received housing assistance from 2015 to 2017 were receiving housing assistance at the time of their delivery hospitalization (63.6%). Conclusion-Although these findings are not nationally representative, this report illustrates how linked NHCS-HUD data may provide insight into maternal health outcomes of patients who received housing assistance compared with those who did not.

Early Childhood in Marginalized Roma Communities: Health Risks and Health Outcomes.

Objectives: This study aims to compare selected early childhood health risks and health outcomes of children from marginalized Roma communities (MRCs) in Slovakia with those of the majority. Methods: We obtained cross-sectional data from mother-child dyads from the majority (N = 109) and MRCs (N = 143) via questionnaires and from medical records. Socioeconomic status, health risks and health outcomes were compared using chi-square and Mann-Whitney U tests in SPSS. Results: Mothers from MRCs reported significantly worse socioeconomic status. Air quality in the households in MRCs was significantly worse, affected by heating with stoves, burning fresh wood and indoor smoking. The diet composition of children from MRCs was characterized by shorter breastfeeding and unhealthy diet composition less fresh fruits and vegetables, more processed meat products, and sweet and salty snacks. Children from MRCs more often suffered from respiratory and diarrheal diseases, used antibiotics and were hospitalized. Conclusion: The health and healthy development of children living in MRCs is endangered by various poverty-related factors. Persistent differences in exposures and health in early childhood should be a priority goal of the state's social and health policies.

Moxibustion for declined cardiorespiratory fitness of apparently healthy older adults: A study protocol for a randomized controlled trial.

BACKGROUND: Aging and age-related declines lead to varying degrees of decreased cardiorespiratory fitness (CRF) in apparently healthy older adults. Exercise training, the primary approach for enhancing CRF, encounters several constraints when used with elderly individuals. Existing evidence implies that moxibustion might enhance the CRF of older adults. However, clinical research in this area still needs to be improved. METHODS: This study will employ a randomized, assessor-blinded, controlled trial design involving 126 eligible participants. These participants will be stratified and randomly assigned to one moxibustion group, one sham moxibustion group, and one blank control group. Acupoints of bilateral Zusanli (ST36), Shenque (CV8), and Guanyuan (CV4) are selected for both real and sham moxibustion groups. The treatment will last 60 min per session, 5 sessions a week for 12 weeks. The blank control group will not receive any intervention for CRF improvement. Primary outcomes will be the mean change in peak oxygen uptake (VO2peak), anaerobic threshold (AT), and serum central carbon metabolites (CCB) from the baseline to observation points. Secondary outcome measures involve the six-minute walk distance (6MWD), the Short Form 36 Health Survey (SF-36), and the Qi and Blood Status Questionnaire (QBSQ). Outcome assessments will be conducted at weeks 4, 8, 12, and 24 as part of the follow-up. Adverse events will be assessed at each visit. DISCUSSION: This trial can potentially ascertain moxibustion's effectiveness and safety in enhancing CRF among apparently healthy older adults. TRAIL REGISTRATION: ChiCTR, ChiCTR2300070303. Registered on April 08, 2023.

Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: the PRECEDENT project.

INTRODUCTION: Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved. METHODS AND ANALYSIS: A COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance. ETHICS AND DISSEMINATION: Ethical approval for the consensus process will be obtained from the Queen's University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely. REGISTRATION: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).

Perceived pressure to breastfeed negatively impacts postpartum mental health outcomes over time.

Introduction: Positive maternal mental health is associated with improved outcomes for infants, and yet the consideration of maternal mental health is often neglected in breastfeeding interventions. Breastfeeding interventions typically focus on breastfeeding promotion, and do not always include supports for the mother. This may result in isolated perceived pressure to breastfeed, the mental health impacts of which are not well understood. Methods: This mixed-methods, longitudinal study examined whether perceived pressure to breastfeed was associated with depression, suicide ideation, anxiety, birth trauma and stress concurrently and 4 weeks later for postpartum mothers. It also examined qualitative experiences of feeding. Results: Perceived pressure to breastfeed was associated with increased anxiety, stress and birth trauma symptoms four weeks later. Thematic analysis suggested this may be due to difficulties living up to the "breast is best" ideal, believing breastfeeding was part of success as a mother, lack of choices and autonomy in feeding choices for infants and general lack of support. Discussion: As such it appears we may be doing more harm than good by focusing our interventions for breastfeeding primarily on increasing pressure to breastfeed, and interventions should consider strategies for promoting positive maternal mental health alongside breastfeeding.

Two-year follow-up of a clustered randomised controlled trial of a multicomponent general practice intervention for people at risk of poor health outcomes.

BACKGROUND: This study was a two-year follow-up evaluation of health service use and the cost-effectiveness of a multicomponent general practice intervention targeted at people at high risk of poor health outcomes. METHODS: A two-year follow-up study of a clustered randomised controlled trial was conducted in South Australia during 2018-19, recruiting 1044 patients from three cohorts: children; adults (aged 18-64 years with two or more chronic diseases); and older adults (aged ≥ 65 years). Intervention group practices (n = 10) provided a multicomponent general practice intervention for 12 months. The intervention comprised patient enrolment to a preferred general practitioner (GP), access to longer GP appointments and timely general practice follow-up after episodes of hospital care. Health service outcomes included hospital use, specialist services and pharmaceuticals. The economic evaluation was based on quality-adjusted life years (QALYs) calculated from EuroQoL 5 dimensions, 5 level utility scores and used an A$50,000 per QALY gained threshold for determining cost-effectiveness. RESULTS: Over the two years, there were no statistically significant intervention effects for health service use. In the total sample, the mean total cost per patient was greater for the intervention than control group, but the number of QALYs gained in the intervention group was higher. The estimated incremental cost-effectiveness ratio (ICER) was A$18,211 per QALY gained, which is lower than the A$50,000 per QALY gained threshold used in Australia. However, the intervention's cost-effectiveness was shown to differ by cohort. For the adult cohort, the intervention was associated with higher costs and lower QALYs gained (vs the total cohort) and was not cost-effective. For the older adults cohort, the intervention was associated with lower costs (A$540 per patient), due primarily to lower hospital costs, and was more effective than usual care. CONCLUSIONS: The positive cost-effectiveness results from the 24-month follow-up warrant replication in a study appropriately powered for outcomes such as hospital use, with an intervention period of at least two years, and targeted to older people at high risk of poor health outcomes.

Qualitative interviews of patients with COPD and muscle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and muscle weakness can cause impaired physical function, significantly impacting patients' health-related quality of life (HRQoL). Loss of muscle strength is usually assessed through clinical and performance outcome (PerfO) assessments, which consists of tasks performed in a standardized manner, providing evidence of a patient's functional ability. However, evidence documenting the patient experience of COPD and muscle weakness is limited. METHODS: This two-stage qualitative study used semi-structured interviews in patients aged 45-80 years with COPD (post-bronchodilator forced expiratory volume in 1s [FEV1]/forced vital capacity ratio < 0.70, and FEV1% predicted of 30-80%) and muscle weakness. In Stage 1, 30-minute concept elicitation interviews were conducted with participants recruited across three US sites to explore impacts on physical functioning and activities of daily living. In Stage 2, interviews were performed with participants exiting a Phase IIa trial investigating the efficacy of a selective androgen receptor modulator (GSK2881078) on leg strength, whereby PerfOs were used to evaluate strength and physical functioning endpoints. These participants completed either 60-minute in-depth (n = 32) or 15-minute confirmatory (n = 35) interviews exploring trial experience, completion of outcome measures, disease experience and treatment satisfaction. RESULTS: In Stage 1 (n = 20), most participants described their muscles as weak (83.3%). Difficulties with walking (100%) and lifting heavy objects (90%) were reported. In Stage 2, 60-minute interviews, all participants (n = 32) reported a positive trial experience. Most participants reported that the home exercise program was easy to fit into daily life (77.8%), the PROactive daily diary was easy to complete (100%) and wearable sensors were easy to use (65.6%). However, technical issues were reported (71%), and few participants (19.4%) found physical assessments easy to complete. Improvements in muscle strength and functional limitations were reported by most participants. The shorter 15-minute confirmatory interviews (n = 35) supported the in-depth interview results. CONCLUSION: The qualitative interviews generated in-depth evidence of key concepts relevant to patients with COPD and muscle weakness and support the assessments of patient strength and physical function as outcome measures in this population in future studies. TRIAL NUMBER: GSK Stage 1: 206869; Stage 2: 200182, NCT03359473; Registered December 2, 2017, https://clinicaltrials.gov/ct2/show/NCT03359473 .

Combining mHealth Technology and Pharmacotherapy to Improve Mental Health Outcomes and Reduce Human Rights Abuses in West Africa: Intervention Field Trial.

Background: In West Africa, healers greatly outnumber trained mental health professionals. People with serious mental illness (SMI) are often seen by healers in "prayer camps" where they may also experience human rights abuses. We developed "M&M," an 8-week-long dual-pronged intervention involving (1) a smartphone-delivered toolkit designed to expose healers to brief psychosocial interventions and encourage them to preserve human rights (M-Healer app), and (2) a visiting nurse who provides medications to their patients (Mobile Nurse). Objective: We examined the feasibility, acceptability, safety, and preliminary effectiveness of the M&M intervention in real-world prayer camp settings. Methods: We conducted a single-arm field trial of M&M with people with SMI and healers at a prayer camp in Ghana. Healers were provided smartphones with M-Healer installed and were trained by practice facilitators to use the digital toolkit. In parallel, a study nurse visited their prayer camp to administer medications to their patients. Clinical assessors administered study measures to participants with SMI at pretreatment (baseline), midtreatment (4 weeks) and post treatment (8 weeks). Results: Seventeen participants were enrolled and most (n=15, 88.3%) were retained. Participants had an average age of 44.3 (SD 13.9) years and 59% (n=10) of them were male. Fourteen (82%) participants had a diagnosis of schizophrenia and 2 (18%) were diagnosed with bipolar disorder. Four healers were trained to use M-Healer. On average, they self-initiated app use 31.9 (SD 28.9) times per week. Healers watched an average of 19.1 (SD 21.2) videos, responded to 1.5 (SD 2.4) prompts, and used the app for 5.3 (SD 2.7) days weekly. Pre-post analyses revealed a significant and clinically meaningful reduction in psychiatric symptom severity (Brief Psychiatric Rating Scale score range 52.3 to 30.9; Brief Symptom Inventory score range 76.4 to 27.9), psychological distress (Talbieh Brief Distress Inventory score range 37.7 to 16.9), shame (Other as Shamer Scale score range 41.9 to 28.5), and stigma (Brief Internalized Stigma of Mental Illness Scale score range 11.8 to 10.3). We recorded a significant reduction in days chained (1.6 to 0.5) and a promising trend for reduction in the days of forced fasting (2.6 to 0.0, P=.06). We did not identify significant pre-post changes in patient-reported working alliance with healers (Working Alliance Inventory), depressive symptom severity (Patient Health Questionnaire-9), quality of life (Lehman Quality of Life Interview for the Mentally Ill), beliefs about medication (Beliefs about Medications Questionnaire-General Harm subscale), or other human rights abuses. No major side effects, health and safety violations, or serious adverse events occurred over the course of the trial. Conclusions: The M&M intervention proved to be feasible, acceptable, safe, and clinically promising. Preliminary findings suggest that the M-Healer toolkit may have shifted healers' behaviors at the prayer camp so that they commit fewer human rights abuses.

User satisfaction with child and adolescent mental health services: the association between user satisfaction and clinical outcomes.

BACKGROUND: This study aimed to examine the association between user satisfaction and clinical outcomes with child and adolescent mental health services (CAMHS) from the perspective of young people and their parents. The evidence bases for CAMHS user satisfaction measures are limited, with few studies investigating the link between user satisfaction and clinical outcomes. In particular, the perspectives of young people are missing. METHODS: The parent and youth versions of the Experience of Service Questionnaire (ESQ), which evaluates the factors of general satisfaction (GS), satisfaction with care (SWC) and satisfaction with environment (SWE), were used to measure user satisfaction. The outcome measures were scores on the Strengths and Difficulties Questionnaire (SDQ), Children's Global Assessment Scale (CGAS), and Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA). Hierarchical regression analysis was conducted on data collected from 233 young people and 495 parents who utilized CAMHS services. RESULTS: GS and SWC predicted outcomes for both young people (ΔR2 = 0.08, p <.05) and parents (ΔR2 = 0.01, p <.05), indicating that user satisfaction had a significant impact on clinical outcomes for CAMHS users. In addition, GS and SWC significantly predicted young people-reported outcomes in the interaction model (ΔR2 = 0.10, p <.05), while no significant association was found with parent-reported outcomes (ΔR2 = 0.02, p =.09). CONCLUSION: User satisfaction, particularly for young people, has a significant impact on clinical outcomes. The causal relationship between user satisfaction and mental health outcomes requires further study.