Outcomes of Best-Practice Guided Digital Mental Health Interventions for Youth and Young Adults with Emerging Symptoms: Part I. A Systematic Review of Socioemotional Outcomes and Recommendations.

Youth-specific digital mental health interventions (DMHI) represent an emerging field of study, and aim to increase access, improve socioemotional outcomes, and, where required, support triage to targeted interventions. However, prior reviews have reported inconsistent findings on the clinical effectiveness of such interventions in young adults (12-25 years). Further, shortfalls remain for the impact of guided interventions based on the mode of delivery and the type of human support personnel (e.g., professional or peer) guiding the intervention. In response, this systematic review, co-designed with Australia's leading mental health organization, aims to assess the effectiveness of guided digital programs in improving youth socioemotional outcomes. Included studies involve young people experiencing mental ill-health, receiving brief (i.e., 1-12 sessions), digitally delivered (at least partially) psychological interventions that were guided or partially guided, tested in a type of experimental study, with a socioemotional outcome. Specific socioemotional outcomes examined were depression, anxiety, stress, wellbeing, mindfulness, and quality of life. A systematic search of the contemporary published and grey literature identified 22,482 records with 32 relevant records published between 2018 and 2023. A narrative synthesis guided integration of findings. Results demonstrated strong evidence for the effectiveness of guided interventions on socioemotional outcomes (i.e., depression, anxiety, stress) yet these effects were short-lived. When factoring in the use of different control groups (i.e., active vs. inactive), inconsistent effects were observed for the socioemotional outcomes of depression, anxiety, and stress. The mode of delivery (i.e., asynchronous, synchronous, combined) and the type of human support personnel did not appear to impact socioemotional outcomes. Results indicate efficacious brief digital interventions for depression and anxiety include refresher/follow-up content, goal setting content, and relapse prevention content. In contrast, poor efficacy is associated with interventions that include homework tasks, self-monitoring, and log-keeping content.PROSPERO, ID CRD42023405812.

Practice, governance, and culture characteristics of lived experience organisations, and evidence of efficacy: A scoping review protocol.

BACKGROUND: Mental health policy and service design is increasingly recognizing the importance of the lived experience voice and its inclusion in all aspects of work. Effective inclusion requires a deeper understanding of how best to support lived experience workforce and community members to meaningfully participate in the system. OBJECTIVES: This scoping review aims to identify key features of organizational practice and governance that facilitate the safe inclusion of lived experience in decision-making and practice within mental health sector contexts. Specifically, the review focuses on mental health organizations devoted to lived experience advocacy or peer support or those in which lived experience membership (paid or voluntary) is central to advocacy and peer support operations. METHODS: This review protocol was prepared with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and registered with the Open Science Framework. The review will be guided by the Joanna Briggs Institute methodology framework and is being conducted by a multidisciplinary team including lived experience research fellows. It will include published and grey literature, including government reports, organizational online documents, and theses. Included studies will be identified through comprehensive searches of five databases: PsycINFO (Ovid), CINAHL (EBSCO), EMBASE (Ovid), MEDLINE (Ovid), and ProQuest Central. Studies published in English from 2000 onwards will be included. Data extraction will be guided by pre-determined extraction instruments. Results will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flow chart. Results will be presented in tabular form and narratively synthesized. The planned commencement and completion dates for this review were July 1, 2022 and April 1, 2023. DISCUSSION: It is anticipated that this scoping review will map the current evidence base underpinning organizational practices in which lived experience workers are involved, specifically in the mental health system. It will also inform future mental health policy and research. TRIAL REGISTRATION: Registration: Open Science Framework (registered: July 26, 2022; registration DOI: 10.17605/OSF.IO/NB3S5).

Methodological and statistical approaches for the assessment of foot shape using three-dimensional foot scanning: a scoping review.

OBJECTIVE: The objectives of this study were to: (i) review and provide a narrative synthesis of three-dimensional (3D) foot surface scanning methodological and statistical analysis protocols, and (ii) develop a set of recommendations for standardising the reporting of 3D foot scanning approaches. METHODS: A systematic search of the SCOPUS, ProQuest, and Web of Science databases were conducted to identify papers reporting 3D foot scanning protocols and analysis techniques. To be included, studies were required to be published in English, have more than ten participants, and involve the use of static 3D surface scans of the foot. Papers were excluded if they reported two-dimensional footprints only, 3D scans that did not include the medial arch, dynamic scans, or derived foot data from a full body scan. RESULTS: The search yielded 78 relevant studies from 17 different countries. The available evidence showed a large variation in scanning protocols. The subcategories displaying the most variation included scanner specifications (model, type, accuracy, resolution, capture duration), scanning conditions (markers, weightbearing, number of scans), foot measurements and definitions used, and statistical analysis approaches. A 16-item checklist was developed to improve the consistency of reporting of future 3D scanning studies. CONCLUSION: 3D foot scanning methodological and statistical analysis protocol consistency and reporting has been lacking in the literature to date. Improved reporting of the included subcategories could assist in data pooling and facilitate collaboration between researchers. As a result, larger sample sizes and diversification of population groups could be obtained to vastly improve the quantification of foot shape and inform the development of orthotic and footwear interventions and products.

Study design and rationale for the TETON phase 3, randomised, controlled clinical trials of inhaled treprostinil in the treatment of idiopathic pulmonary fibrosis.

INTRODUCTION: Idiopathic pulmonary fibrosis (IPF) greatly impacts quality of life and eventually leads to premature death from respiratory failure. Inhaled treprostinil was associated with improvements in forced vital capacity (FVC) and reduced exacerbations of underlying lung disease in post hoc analyses from a phase 3 study in patients with precapillary pulmonary hypertension due to interstitial lung disease. These results, combined with preclinical evidence of treprostinil's antifibrotic activity, support its investigation in the treatment of IPF. METHODS AND ANALYSIS: The TETON programme consists of two replicate, 52-week, randomised, double-blind placebo-controlled, phase 3 studies, each enrolling 396 subjects (NCT04708782, NCT05255991). Eligible subjects must have a diagnosis of IPF confirmed by central imaging review, along with an FVC ≥45%. Stable background use of pirfenidone or nintedanib is allowed. The primary endpoint is change in absolute FVC at week 52. Secondary endpoints include time to clinical worsening (first event of death, respiratory hospitalisation or ≥10% decline in % predicted FVC), time to first acute exacerbation of IPF, overall survival, change in % predicted FVC and change in the King's Brief Interstitial Lung Disease Questionnaire at week 52. Safety parameters include adverse events, hospitalisations, oxygenation and laboratory parameters. Patients who complete week 52 will be eligible to enter an open-label extension study. ETHICS AND DISSEMINATION: Studies will be conducted in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice, Declaration of Helsinki principles, and local regulatory, ethical and legal requirements. Results will be published in a peer-reviewed publication.

Adverse effects of pegaspargase in pediatric patients receiving doses greater than 3,750 IU.

BACKGROUND: Increased toxicities have been identified with higher doses of pegaspargase (PEG-ASP) in adults. This has led to routine use of a dose cap of 3,750 IU for adult acute lymphoblastic leukemia (ALL) patients in most institutions. In pediatric ALL patients, PEG-ASP is not capped. There is concern at our institution that larger doses may result in increased rates of adverse effects and that increased monitoring may be warranted in pediatric patients receiving doses greater than 3,750 IU. The objective of this study is to quantify the difference in the rates of PEG-ASP-associated adverse events between pediatric patients who received doses greater than 3,750 IU and less than or equal to 3,750 IU. METHODS: Retrospective chart review of patients 1-21 years old with pre-B-cell ALL who received PEG-ASP between 2007 and 2014 at an academic medical center. RESULTS: Of 183 patients included in the analysis, 24 received PEG-ASP doses higher than 3,750 IU and 159 received doses less than or equal to 3,750 IU. The incidence of venous thromboembolism (VTE) was significantly higher for patients in the group that received more than 3,750 IU compared with those who received 3,750 IU or less (20.8 vs. 1.89%, respectively; P = 0.0011). The incidence of pancreatitis (P = 0.0306) and hyperglycemia (P = 0.0089) were also higher in the group that received more than 3,750 IU. CONCLUSIONS: PEG-ASP doses higher than 3,750 IU are associated with higher rates of VTE, pancreatitis, and hyperglycemia in pediatric patients with pre-B-cell ALL. Patients receiving more than 3,750 IU should have increased monitoring, and larger, multicenter trials are needed to determine if monitoring, VTE prophylaxis, and potential dose capping recommendations should be added to clinical trial protocols.

Integrating New Pharmacologic Agents into Heart Failure Care: Role of Heart Failure Practice Guidelines in Meeting This Challenge.

Heart failure is well recognized as a major public health concern not only due to severe and frequent adverse health outcomes but also related to the major financial burden this syndrome presents with advancing age in Western societies. Despite the dire need for more efficacious therapies and better application of existing advances, treatment gaps persist, and outcomes in heart failure remain poor, with continually high mortality and morbidity. Treatment guidelines provide one strategy for advancing quality of care in patients with heart failure. This approach, with well-known potential strengths and weaknesses, has both adherents and detractors. Heart failure treatment guidelines have been in sharp focus recently due to updates that address the United States Food and Drug Administration (FDA) approval in 2015 of two new pharmacologic therapies for heart failure with reduced ejection fraction: sacubitril-valsartan and ivabradine. Our commentary will revisit issues in guideline methodology and discuss these in the context of the updates addressing the FDA approval of new pharmacologic agents for heart failure with reduced ejection fraction.

A scoping review of Australian allied health research in ehealth.

BACKGROUND: Uptake of e-health, the use of information communication technologies (ICT) for health service delivery, in allied health appears to be lagging behind other health care areas, despite offering the potential to address problems with service access by rural and remote Australians. The aim of the study was to conduct a scoping review of studies into the application of or attitudes towards ehealth amongst allied health professionals conducted in Australia. METHODS: Studies meeting inclusion criteria published from January 2004 to June 2015 were reviewed. Professions included were audiology, dietetics, exercise physiology, occupational therapy, physiotherapy, podiatry, social work, and speech pathology. Terms for these professions and forms of ehealth were combined in databases of CINAHL (EBSCO), Cochrane Library, PsycINFO (1806 - Ovid), MEDLINE (Ovid) and AMED (Ovid). RESULTS: Forty-four studies meeting inclusion criteria were summarised. They were either trials of aspects of ehealth service delivery, or clinician and/or client use of and attitudes towards ehealth. Trials of ehealth were largely from two research groups located at the Universities of Sydney and Queensland; most involved speech pathology and physiotherapy. Assessments through ehealth and intervention outcomes through ehealth were comparable with face-to-face delivery. Clinicians used ICT mostly for managing their work and for professional development, but were reticent about its use in service delivery, which contrasted with the more positive attitudes and experiences of clients. CONCLUSION: The potential of ehealth to address allied health needs of Australians living in rural and remote Australia appears unrealised. Clinicians may need to embrace ehealth as a means to radicalise practice, rather than replicate existing practices through a different mode of delivery.