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.

A Review of Disparities in Outcomes of Hospitalized Patients with Limited English Proficiency: The Importance of Nursing Resources.

Language barriers significantly affect communication between patients and health care staff and are associated with receipt of lower-quality care. Registered nurses are well positioned members of the health care team to reduce and eliminate disparities for patients with limited English proficiency (LEP). Current evidence recommends nurses use interpreters or translation devices to overcome language barriers; however, these recommendations fail to recognize that structural system-level factors, such as unsupportive work environments and poor nurse-to-patient staffing ratios, reduce nurses' ability to implement these recommendations. The Quality Health Outcomes Model (QHOM) is a useful framework for understanding relationships between hospital systems, the delivery of care interventions, and patient outcomes. The goal of this manuscript is to use the QHOM and existing empirical evidence to present a new perspective on the long-standing clinical challenge of reducing language-related health outcome disparities by considering the context in which nurses deliver patient care.

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.

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 .

Machine learning methods, applications and economic analysis to predict heart failure hospitalisation risk: a scoping review protocol.

INTRODUCTION: Machine learning (ML) has emerged as a powerful tool for uncovering patterns and generating new information. In cardiology, it has shown promising results in predictive outcomes risk assessment of heart failure (HF) patients, a chronic condition affecting over 64 million individuals globally.This scoping review aims to synthesise the evidence on ML methods, applications and economic analysis to predict the HF hospitalisation risk. METHODS AND ANALYSIS: This scoping review will use the approach described by Arksey and O'Malley. This protocol will use the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocol, and the PRISMA extension for scoping reviews will be used to present the results. PubMed, Scopus and Web of Science are the databases that will be searched. Two reviewers will independently screen the full-text studies for inclusion and extract the data. All the studies focusing on ML models to predict the risk of hospitalisation from HF adult patients will be included. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. The dissemination strategy includes peer-reviewed publications, conference presentations and dissemination to relevant stakeholders.

Validity and reliability of outcome measures to assess dysfunctional breathing: a systematic review.

OBJECTIVE: This study aimed to systematically review the psychometric properties of outcome measures that assess dysfunctional breathing (DB) in adults. METHODS: Studies on developing and evaluating measurement properties to assess DB were included. The study investigated the empirical research published between 1990 and February 2022, with an updated search in May 2023 in the Cochrane Library database of systematic reviews and the Cochrane Central Register of Controlled Trials, the Ovid Medline (full), the Ovid Excerta Medica Database, the Ovid allied and complementary medicines database, the Ebscohost Cumulative Index to Nursing and Allied Health Literature and the Physiotherapy Evidence Database. The included studies' methodological quality was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist. Data analysis and synthesis followed the COSMIN methodology for reviews of outcome measurement instruments. RESULTS: Sixteen studies met the inclusion criteria, and 10 outcome measures were identified. The psychometric properties of these outcome measures were evaluated using COSMIN. The Nijmegen Questionnaire (NQ) is the only outcome measure with 'sufficient' ratings for content validity, internal consistency, reliability and construct validity. All other outcome measures did not report characteristics of content validity in the patients' group. DISCUSSION: The NQ showed high-quality evidence for validity and reliability in assessing DB. Our review suggests that using NQ to evaluate DB in people with bronchial asthma and hyperventilation syndrome is helpful. Further evaluation of the psychometric properties is needed for the remaining outcome measures before considering them for clinical use. PROSPERO REGISTRATION NUMBER: CRD42021274960.

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.

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.

Identifying research gaps in climate-related mental health outcomes in North America and Europe: a qualitative framework analysis.

BACKGROUND: Climate change and mental health outcomes are two of the most pressing global crises. Despite the increasing global mental health burden, climate-related mental health outcomes research is nascent and isolated, with substantial gaps across regions and disciplines. Connecting Climate Minds is a global initiative connecting researchers, experts, and people with lived experience of adverse mental health outcomes to identify regional research needs and create a community to support improved climate-related mental health outcomes. METHODS: We focused on North America and Europe as part of the global Connecting Climate Minds effort, using semi-structured interviews, focus groups, regional dialogues (ie, discussions between experts in climate health, planetary health, human health, and mental health and with lived experience to discuss the climate threats most affecting their communities, their effects on mental health, and opportunities for action), and a literature review to identify crucial research gaps in climate change and mental health. We collected insights into priorities when addressing mental health outcomes related to climate change in Europe and North America; requirements for effective research, policy, and practice; and encouraging collaboration from a diverse community that included experts, researchers, practitioners from multiple disciplines, indigenous groups, and youth representatives. We used a qualitative framework analysis to identify consensus priorities. FINDINGS: Several themes emerged regarding research gaps. First, research into the effects of climate change on mental health is needed (eg, how pre-existing mental health outcomes are affected by climate disaster events, risk factors and protective factors, the effects of climate action or inaction on mental health, and economic costs). Second, investigating connections between climate-related mental health outcomes and Indigenous and other cultural practices (eg, the effects of climate change on Indigenous peoples and practices, cultural variations in mental health responses, and the effectiveness of integrating Indigenous and cultural knowledge into mental health interventions). Third, mixed-methods research is needed to explore the relationships between climate change, global and national economies, and governance and their associations with mental health outcomes. Fourth, evaluating social and cultural connectedness in mental health outcomes and climate change, community-level interventions, and the effectiveness of climate-education programmes that incorporate mental health considerations are research priorities. Finally, understanding how emerging technology can be used to understand climate-related mental health outcomes and use of technology to collect, analyse, and respond to population health data (with ethical considerations). INTERPRETATION: Connecting Climate Minds aims to psychologically equip people in Europe and North America to navigate the challenges of a changing climate. Climate-related mental health experts in should collaborate and encourage research and action that are proactive, community-led, and accessible. FUNDING: Imperial College London, the Wellcome Trust, and the Planetary Health Alliance via Harvard University.

[Status of outcome measures in randomized controlled trials of kidney-tonifying and blood-activating method in treatment of knee osteoarthritis].

This study assesses the status of outcome measures in the randomized controlled trial(RCT) involving the kidney-tonif-ying and blood-activating method for treating knee osteoarthritis(KOA), aiming to establish a theoretical foundation for the development of a core set of outcome measures in traditional Chinese medicine(TCM) treatment of KOA. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, in addition to ClinicalTrials.gov and the China Clinical Trial Registration Center, with the time interval from inception to August 2023. The RCT of treating KOA with the kidney-tonifying and blood-activating method was included. Two assessors independently conducted literature screening, data collection, and qualitative analysis to compile the outcome measure results. A total of 350 RCTs were included, involving 165 outcome measures with the total frequency of 1 462. These outcome measures were categorized into six domains: symptom and sign measures(23) with the frequency of 718(49.1%), TCM symptom and syndrome measures(3) with the frequency of 53(3.6%), physical examination measures(130) with the frequency of 506(34.6%), quality of life measures(4) with the frequency of 20(1.3%), long-term efficacy measures(2) with the frequency of 6(0.4%), and safety measures(3) with the frequency of 159(10.9%). Additionally, 53 studies used TCM syndrome and symptom scores as indicators of efficacy, employing eight distinct measurement tools. The RCTs involving the kidney-tonifying and blood-activating method for treating KOA had a variety of problems, such as unclear prio-ritization of outcome measures, diversity in measurement tools, absence of standardized assessment criteria for specific measures, and non-standardized usage. These problems affected the research quality and reliability. Hence, it is advisable to draw upon international expertise, improve research design, and merge TCM efficacy characteristics with clinical research to establish a core set of KOA outcome measures aligned with TCM principles.

Health outcomes in Deaf signing populations: A systematic review.

OBJECTIVES: (i) To identify peer reviewed publications reporting the mental and/or physical health outcomes of Deaf adults who are sign language users and to synthesise evidence; (ii) If data available, to analyse how the health of the adult Deaf population compares to that of the general population; (iii) to evaluate the quality of evidence in the identified publications; (iv) to identify limitations of the current evidence base and suggest directions for future research. DESIGN: Systematic review. DATA SOURCES: Medline, Embase, PsychINFO, and Web of Science. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: The inclusion criteria were Deaf adult populations who used a signed language, all study types, including methods-focused papers which also contain results in relation to health outcomes of Deaf signing populations. Full-text articles, published in peer-review journals were searched up to 13th June 2023, published in English or a signed language such as ASL (American Sign Language). DATA EXTRACTION: Supported by the Rayyan systematic review software, two authors independently reviewed identified publications at each screening stage (primary and secondary). A third reviewer was consulted to settle any disagreements. Comprehensive data extraction included research design, study sample, methodology, findings, and a quality assessment. RESULTS: Of the 35 included studies, the majority (25 out of 35) concerned mental health outcomes. The findings from this review highlighted the inequalities in health and mental health outcomes for Deaf signing populations in comparison with the general population, gaps in the range of conditions studied in relation to Deaf people, and the poor quality of available data. CONCLUSIONS: Population sample definition and consistency of standards of reporting of health outcomes for Deaf people who use sign language should be improved. Further research on health outcomes not previously reported is needed to gain better understanding of Deaf people's state of health.

Domestic dogs maintain clinical, nutritional, and hematological health outcomes when fed a commercial plant-based diet for a year.

Domestic dogs can maintain health on complete and well-balanced canine plant-based nutrition (K9PBN). Novel insight on health outcomes in dogs consuming K9PBN is of relevance to veterinary professionals and consumers given a growing interest in non-traditional dog foods with perceived health benefits, while considering potential safety concerns. We aimed to investigate nutritional equivalence by measuring clinical health outcomes in adult dogs fed K9PBN over twelve months compared to a meat-based diet at baseline. We enrolled fifteen clinically healthy adult dogs living in households in Los Angeles County, California in a prospective cohort study and evaluated clinical, hematological, and nutritional parameters in dogs at 0, 6, and 12 months, including complete blood count (CBC), blood chemistry, cardiac biomarkers, plasma amino acids, and serum vitamin concentrations. The study found that clinically healthy, client-owned, adult dogs maintain health, based on physical exams, complete blood count, serum chemistry, plasma amino acids, serum vitamins, and cardiac biomarkers combined with client-reported observations, when fed commercial K9PBN over a twelve-month period. This study is the most comprehensive and longest known K9PBN investigation to date and provides clinically relevant evidence-based nutrition data and new knowledge on outcomes in clinically healthy dogs who thrive without consumption of animal-derived ingredients. These results also provide a valuable foundation for the future study of K9PBN as a potential nutritional intervention for clinically relevant pathologies in canine medicine. Lastly, it is of major relevance to One Health paradigms since ingredients produced independent of industrial food animal production are both more sustainable and help to circumvent ethical dilemmas for maintenance of health in domestic dogs.

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.

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.

Feasibility of a quality-improvement program based on routinely collected health outcomes in Dutch primary care physical therapist practice: a mixed-methods study.

BACKGROUND: This study evaluates the feasibility of a nine-month advanced quality-improvement program aimed at enhancing the quality of care provided by primary care physical therapists in the Netherlands. The evaluation is based on routinely collected health outcomes of patients with nonspecific low back pain, assessing three feasibility domains: (1) appropriateness, feasibility, and acceptability for quality-improvement purposes; (2) impact on clinical performance; and (3) impact on learning and behavioral change. METHODS: A mixed-methods quality-improvement study using a concurrent triangulation design was conducted in primary care physical therapist practice. Feedback reports on the processes and outcomes of care, peer assessment, and self-assessment were used in a Plan-Do-Study-Act cycle based on self-selected goals. The program's appropriateness, feasibility, and acceptability, as well as the impact on clinical performance, were evaluated using the Intervention Appropriate Measure, Feasibility Intervention Measure, Acceptability Intervention Measure (for these three measure, possible scores range from 4 to 20), and with a self-assessment of clinical performance (scored 0-10), respectively. The impact on learning and behavioral change was evaluated qualitatively with a directed content analysis. RESULTS: Ten physical therapists from two practices participated in this study. They rated the program with a mean of 16.5 (SD 1.9) for appropriateness, 17.1 (SD 2.2) for feasibility, and 16.4 (SD 1.5) for acceptability. Participants gave their development in clinical performance a mean score of 6.7 (SD 1.8). Participants became aware of the potential value of using outcome data and gained insight into their own routines and motivations. They changed their data collection routines, implemented data in their routine practice, and explored the impact on their clinical behavior. CONCLUSIONS: This explorative study demonstrated that a quality-improvement program, using health outcomes from a national registry, is judged to be feasible. IMPACT STATEMENT: This study provides preliminary evidence on how physical therapists may use health outcomes to improve their quality, which can be further used in initiatives to improve outcome-based care in primary physical therapy.

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.