Randomised, controlled, feasibility trial comparing vasopressor infusion administered via peripheral cannula versus central venous catheter for critically ill adults: A study protocol.

BACKGROUND: When clinicians need to administer a vasopressor infusion, they are faced with the choice of administration via either peripheral intravenous catheter (PIVC) or central venous catheter (CVC). Vasopressor infusions have traditionally been administered via central venous catheters (CVC) rather than Peripheral Intra Venous Catheters (PIVC), primarily due to concerns of extravasation and resultant tissue injury. This practice is not guided by contemporary randomised controlled trial (RCT) evidence. Observational data suggests safety of vasopressor infusion via PIVC. To address this evidence gap, we have designed the "Vasopressors Infused via Peripheral or Central Access" (VIPCA) RCT. METHODS: The VIPCA trial is a single-centre, feasibility, parallel-group RCT. Eligible critically ill patients requiring a vasopressor infusion will be identified by emergency department (ED) or intensive care unit (ICU) staff and randomised to receive vasopressor infusion via either PIVC or CVC. Primary outcome is feasibility, a composite of recruitment rate, proportion of eligible patients randomised, protocol fidelity, retention and missing data. Primary clinical outcome is days alive and out of hospital up to day-30. Secondary outcomes will include safety and other clinical outcomes, and process and cost measures. Specific aspects of safety related to vasopressor infusions such as extravasation, leakage, device failure, tissue injury and infection will be assessed. DISCUSSION: VIPCA is a feasibility RCT whose outcomes will inform the feasibility and design of a multicentre Phase-3 trial comparing routes of vasopressor delivery. The exploratory economic analysis will provide input data for the full health economic analysis which will accompany any future Phase-3 RCT.

Supporting equitable care of patients transferred from police watch-houses to the emergency department: A qualitative study of the perspectives of emergency doctors.

OBJECTIVE: People detained in short-term police custody often have complex health conditions that may necessitate emergency care, yet little is known about their management in EDs. The present study aimed to understand ED doctors' experiences and perceptions regarding the appropriateness and management of detainee transfers from police watch-houses to the EDs. METHODS: A qualitative descriptive study, using semi-structured interviews undertaken with ED doctors working in five purposively sampled EDs across Queensland, Australia. Data were analysed using inductive content analysis. RESULTS: Fifteen ED specialists and trainees participated. Participants reported that their overarching approach was to provide equitable care for watch-house detainees, as they would for any patient. This equitable approach needed to be responsive to complicating factors common to this population, including presence of police guards; restraints; complexity (physical/mental/social) of presentation; reliance on police to transport; ED doctors' often limited understanding of the watch-house environment; justice processes and uncertain legal disposition; communication with the watch-house; and detainees misreporting symptoms. Thresholds for assessment and treatment of detainees were contextualised to the needs of the patient, ED environment, and imperatives of other relevant agencies (e.g. police). Participants often relied on existing strategies to deliver quality care despite challenges, but also identified a need for additional strategies, including education for ED staff; improved communication with watch-houses; standardised paperwork; extended models of watch-house healthcare; and integrated medical records. CONCLUSIONS: Providing equitable healthcare to patients transported from watch-houses to the EDs is challenging but essential. Numerous opportunities exist to enhance the delivery of optimal care for this underserved population.

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

Patient-Led, Technology-Assisted Malnutrition Risk Screening in Hospital: A Feasibility Study.

Malnutrition risk screening is crucial to identify at-risk patients in hospitals; however, screening rates can be suboptimal. This study evaluated the feasibility, acceptability, and potential cost-effectiveness of patient-led, technology-assisted malnutrition risk screening. A prospective multi-methods study was conducted in a 750-bed public hospital in Australia. Patients were recruited from seven wards and asked to complete an electronic version of the Malnutrition Screening Tool (e-MST) on bedside computer screens. Data were collected on feasibility, acceptability, and cost. Feasibility data were compared to pre-determined criteria on recruitment (≥50% recruitment rate) and e-MST completion (≥75% completion rate). Quantitative acceptability (survey) data were analyzed descriptively. Patient interview data were analyzed thematically. The economic evaluation was from the perspective of the health service using a decision tree analytic model. Both feasibility criteria were met; the recruitment rate was 78% and all 121 participants (52% male, median age 59 [IQR 48-69] years) completed the e-MST. Patient acceptability was high. Patient-led e-MST was modeled to save $3.23 AUD per patient and yield 6.5 more true malnutrition cases (per 121 patients) with an incremental cost saving per additional malnutrition case of 0.50 AUD. Patient-led, technology-assisted malnutrition risk screening was found to be feasible, acceptable to patients, and cost-effective (higher malnutrition yield and less costly) compared to current practice at this hospital.

'The big value of it is getting the patient seen by the right person at the right time': clinician perceptions of the value of allied health primary contact models of care.

Allied health primary contact clinic models of care have increasingly been used as a strategy to increase public health service capacity. A recent systematic review found little consistency or agreement on how primary contact clinics are evaluated. The concept of value of primary contact clinics, which has important implications for evaluation, has not yet been explored in-depth. To explore allied health clinicians' perceptions of the value of allied health primary contact clinics, with the goal of informing an evaluation framework, a descriptive qualitative approach utilizing semi-structured interviews was employed. Participants included allied health staff embedded in clinical lead roles within primary contact clinics across four acute care hospitals in a metropolitan health service located in South-East Queensland, Australia. Lead staff from 30 identified primary contact clinic models in the health service were approached to take part via email. All eligible participants who provided consent were included. An inductive thematic analysis approach was used. A total of 23 clinicians (n = 23) representing 22 diverse models of primary contact clinics participated. Most participants were physiotherapists, dietitians, or occupational therapists, although speech pathology, audiology, and podiatry were also represented. Participant perceptions of the 'value' of PCCs were a highly complex phenomenon, comprising five intersecting domains: (i) patient satisfaction; (ii) clinical outcomes; (iii) care pathway and resource use; (iv) health service performance; and (v) staff satisfaction and professional standing. These five core value domains were positively or negatively influenced by 12 perceived benefits and 8 perceived drawbacks, respectively. Value domains were also highly interrelated and impacted upon each other. The concept of 'value' relating to primary contact clinics involves multiple intersecting domains encompassing different perspectives. This study highlighted potential benefits and drawbacks of primary contact clinics that have not yet been measured or explored in the literature, and as such may be useful for healthcare administrators to consider. The findings of this study will inform an evaluation framework including health economics calculator for primary contact clinics.

An mHealth application for chronic vascular access: Consumer led co-creation.

PURPOSE: Children with chronic and complex health conditions frequently need intravenous devices. The current approach to intravenous device selection, insertion, and monitoring is inconsistent, and healthcare consumers are often negatively affected by siloed health information, and poor future planning. Despite child- and family-centred care being recognised as a pillar of paediatric nursing care, limited implementation for vascular access device planning and management is evident. DESIGN AND METHODS: To address this, we conducted a multi-phased approach to co-create, then evaluate, a mobile health (mHealth) application: IV Passport. Co-creation involved a prioritisation survey, followed by a Passport advisory panel consensus meeting. Following confirmation of the required content and features of the Passport, the mHealth application was designed and content validation achieved via survey. RESULTS: The prioritisation survey yielded recommendations for seven features (e.g., graphical presentations of current/past devices). Content for nine device types (e.g., totally implanted ports) was suggested, each with 10 related items (e.g., insertion site). Content items for device-associated complications, future vascular access plans, and educational resources were also suggested. Following design, the application was released through Apple and Android platforms; and adapted to a paper version. Content validation was established; 100% strongly agreed the application was easy to use; 80% agreed/strongly agreed that they would recommend the Passport to others. CONCLUSION: IV Passport embodies effective child- and family-centred care through consumer co-creation to empower patients and families manage vascular access devices. PRACTICE IMPLICATIONS: IV Passport remains active; and can be utilised across many healthcare settings and patient populations.

An mHealth application for chronic vascular access: A multi-method evaluation.

BACKGROUND: Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose. AIM: In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport. DESIGN: Multi-site, parallel, multi-method, prospective cohort study. METHODS: A multi-site, multi-method study was carried out in 2020-2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months. RESULTS: Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5-10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality. CONCLUSION: Several recommendations were made to improve the end-user experience including 'how to' instructions; and scheduling functionality for routine care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The IV Passport can be safely and appropriately integrated into healthcare, to support consumers. IMPACT: Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians. REPORTING METHOD: Not applicable. PATIENT CONTRIBUTION: Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

Associations between facial expressions and observational pain in residents with dementia and chronic pain.

AIM: To identify specific facial expressions associated with pain behaviors using the PainChek application in residents with dementia. DESIGN: This is a secondary analysis from a study exploring the feasibility of PainChek to evaluate the effectiveness of a social robot (PARO) intervention on pain for residents with dementia from June to November 2021. METHODS: Participants experienced PARO individually five days per week for 15 min (once or twice) per day for three consecutive weeks. The PainChek app assessed each resident's pain levels before and after each session. The association between nine facial expressions and the adjusted PainChek scores was analyzed using a linear mixed model. RESULTS: A total of 1820 assessments were completed with 46 residents. Six facial expressions were significantly associated with a higher adjusted PainChek score. Horizontal mouth stretch showed the strongest association with the score, followed by brow lowering parting lips, wrinkling of the nose, raising of the upper lip and closing eyes. However, the presence of cheek raising, tightening of eyelids and pulling at the corner lip were not significantly associated with the score. Limitations of using the PainChek app were identified. CONCLUSION: Six specific facial expressions were associated with observational pain scores in residents with dementia. Results indicate that automated real-time facial analysis is a promising approach to assessing pain in people with dementia. However, it requires further validation by human observers before it can be used for decision-making in clinical practice. IMPACT: Pain is common in people with dementia, while assessing pain is challenging in this group. This study generated new evidence of facial expressions of pain in residents with dementia. Results will inform the development of valid artificial intelligence-based algorithms that will support healthcare professionals in identifying pain in people with dementia in clinical situations. REPORTING METHOD: The study adheres to the CONSORT reporting guidelines. PATIENT OR PUBLIC CONTRIBUTION: One resident with dementia and two family members of people with dementia were consulted and involved in the study design, where they provided advice on the protocol, information sheets and consent forms, and offered valuable insights to ensure research quality and relevance. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry number (ACTRN12621000837820).

Health-related quality of life and experience measures, to assess patients' experiences of peripheral intravenous catheters: a secondary data analysis.

BACKGROUND: Peripheral intravenous catheters (PIVCs) are essential for successful administration of intravenous treatments. However, insertion failure and PIVC complications are common and negatively impact patients' health-outcomes and experiences. We aimed to assess whether generic (not condition-specific) quality of life and experience measures were suitable for assessing outcomes and experiences of patients with PIVCs. METHODS: We undertook a secondary analysis of data collected on three existing instruments within a large randomised controlled trial, conducted at two adult tertiary hospitals in Queensland, Australia. Instruments included the EuroQol Five Dimension - Five Level (EQ5D-5L), the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General measure (FACIT-TS-G, eight items), and the Australian Hospital Patient Experience Question Set (AHPEQS, 12 items). Responses were compared against two clinical PIVC outcomes of interest: all-cause failure and multiple insertion attempts. Classic descriptives were reported for ceiling and floor effects. Regression analyses examined validity (discrimination). Standardised response mean and effect size (ES) assessed responsiveness (EQ5D-5L, only). RESULTS: In total, 685 participants completed the EQ5D-5L at insertion and 526 at removal. The FACIT-TS-G was completed by 264 and the AHPEQS by 262 participants. Two FACIT-TS-G items and one AHPEQS item demonstrated ceiling effect. Instruments overall demonstrated poor discrimination, however, all-cause PIVC failure was significantly associated with several individual items in the instruments (e.g., AHPEQS, 'unexpected physical and emotional harm'). EQ5D-5L demonstrated trivial (ES < 0.20) responsiveness. CONCLUSIONS: Initial investigation of an existing health-related quality of life measure (EQ5D-5L) and two patient-reported experience measures (FACIT-TS-G; AHPEQS) suggest they are inadequate (as a summary measure) to assess outcomes and experiences for patients with PIVCs. Reliable instruments are urgently needed to inform quality improvement and benchmark standards of care.

Measuring performance in allied health professional role substitution models of care: a clinician survey.

BACKGROUND: Professional role substitution models of care have emerged as a key strategy to address increasing healthcare demand. Gaining insights from those actively engaged in the process of these models' implementation and evaluation is pivotal to ensuring sustainability and further successful implementation. The purpose of this study was to describe allied-health clinicians' perceptions, practice, and experiences of healthcare performance evaluation in professional role substitution models of care. METHODS: Data were collected via an online platform between 22 June - 22 July 2022 using a combination of convenience and network-based sampling of allied-health clinicians involved or interested in the implementation and evaluation of professional role substitution models of care. Clinicians answered 25 questions which consisted of demographic and targeted questions regarding performance evaluation across six domains of healthcare quality (effectiveness, safety, appropriateness, access & equity, continuity of care, and cost, efficiency, productivity & sustainability). RESULTS: A total of 102 clinicians accessed the survey, with 72 providing complete survey data. Eleven allied-health professions were represented, working across twelve specialities in thirteen hospital and health services. Whilst most allied-health clinicians (93-100%) supported measuring performance in each of the six healthcare quality domains, only 26-58% were measuring these domains in practice. Allied-health leadership support (62.5%), clinician drive (62.5%), consumer engagement (50%) and medical support (46%) were enablers whilst a lack of resources (human, time, financial (47%)), healthcare performance frameworks and/or policies (40%) were identified as barriers. Given the opportunity, clinicians would invest the most financial resources in digital solutions as a core strategy to improve performance evaluation. CONCLUSIONS: Allied-health professionals expressed strong support for principles of performance evaluation, however in practice, performance evaluation is still in its infancy in professional role substitution models of care. Organisations can implement strategies that maximise the enablers whilst addressing barriers identified to improve performance evaluation in these models of care.

Health-related quality of life in people with different diabetes-related foot ulcer health states: A cross-sectional study of healed, non-infected, infected, hospitalised and amputated ulcer states.

AIMS: Diabetes-related foot ulcers (DFU) are a leading cause of infection, hospitalisation and amputation. However, to our knowledge no studies have compared the health-related quality of life (HRQoL) of people with DFU that were infected, hospitalised or amputated. This study aimed to investigate and compare the HRQoL of different groups of people with healed, non-infected, infected, hospitalised, or amputated DFU. METHODS: This was a multi-centre cross-sectional study measuring the HRQoL of patients, attending one of 18 Diabetic Foot Services across Queensland, Australia, with one of five DFU health states: healed, non-infected, infected, hospitalised, amputated. HRQoL was measured using the EQ-5D-5L to estimate age-sex adjusted utility values. RESULTS: Of 376 included patients (mean age 63 (12) years, 75% male), age-sex adjusted HRQoL utility estimates (95% CIs) were: healed DFU 0.57 (0.51-0.64), non-infected DFU 0.55 (0.49-0.62), infected DFU 0.45 (0.36-0.55), hospitalised DFU 0.53 (0.42-0.64), and amputated DFU 0.55 (0.46-0.63). CONCLUSION: People in any DFU health state have considerably reduced HRQoL, with greatest reductions in those with infected DFU. These findings provide valuable HRQoL estimates and comparisons for several different important DFU health states, adding to our understanding of the impact of DFU on HRQoL and facilitating future economic evaluations.

Implementing paediatric appropriate use criteria for endotracheal suction to reduce complications in mechanically ventilated children with respiratory infections.

BACKGROUND: Endotracheal suction is used to maintain endotracheal tube patency. There is limited guidance to inform clinical practice for children with respiratory infections. OBJECTIVE: The objective of this study was to determine whether implementation of a paediatric endotracheal suction appropriate use guideline Paediatric AirWay Suction (PAWS) is associated with an increased use of appropriate and decreased use of inappropriate suction interventions. METHODS: A mixed-method, pre-implementation-post-implementation study was conducted between September 2021 and April 2022. Suction episodes in mechanically ventilated children with a respiratory infection were eligible. Using a structured approach, we implemented the PAWS guideline in a single paediatric intensive care unit. Evaluation included clinical (e.g., suction intervention appropriateness), implementation (e.g., acceptability), and cost outcomes (implementation costs). Associations between implementation of the PAWS guideline and appropriateness of endotracheal suction intervention use were investigated using generalised linear models. RESULTS: Data from 439 eligible suctions were included in the analysis. Following PAWS implementation, inappropriate endotracheal tube intervention use reduced from 99% to 58%, an absolute reduction (AR) of 41% (95% confidence interval [CI]: 25%, 56%). Reductions were most notable for open suction systems (AR: 48%; 95% CI: 30%, 65%), 0.9% sodium chloride use (AR: 23%; 95% CI: 8%, 38%) and presuction and postsuction manual bagging (38%; 95% CI: 16%, 60%, and 86%; 95% CI: 73%, 99%), respectively. Clinicians perceived PAWS as acceptable and suitable for use. CONCLUSIONS: Implementation of endotracheal tube suction appropriate use guidelines in a mixed paediatric intensive care unit was associated with a large reduction in inappropriate suction intervention use in paediatric patients with respiratory infections.

A non-randomised feasibility study of a mHealth follow-up program in bariatric surgery.

BACKGROUND: Behavioural support via mobile health (mHealth) is emerging. This study aimed to assess the feasibility, acceptability, cost, and potential effect on weight of a mHealth follow-up program in bariatric surgery. METHODS: This was a non-randomised feasibility study describing intervention development and proof in the concept of a mHealth follow-up program in bariatric surgery. The study compares a prospective cohort with a historical control group and was conducted in a tertiary bariatric surgery service in Australia. The intervention group included individuals who had bariatric surgery (2019-2021) and owned a smart device, and the historical control group received usual postoperative care (2018). The intervention involved usual care plus codesigned biweekly text messages, monthly email newsletters, and online resources/videos over a 6-month period. The primary outcome measures included feasibility (via recruitment and retention rate), acceptability (via mixed methods), marginal costs, and weight 12 months postoperatively. Quantitative analysis was performed, including descriptive statistics and inferential and regression analysis. Multivariate linear regression and mixed-effects models were undertaken to test the potential intervention effect. Qualitative analysis was performed using inductive content analysis. RESULTS: The study included 176 participants (n = 129 historical control, n = 47 intervention group; mean age 56 years). Of the 50 eligible patients, 48 consented to participate (96% recruitment rate). One participant opted out of the mHealth program entirely without disclosing their reason (98% retention rate). The survey response rate was low (n = 16/47, 34%). Participants agreed/strongly agreed that text messages supported new behaviours (n = 13/15, 87%); however, few agreed/strongly agreed that the messages motivated goal setting and self-monitoring (n = 8/15, 53%), dietary change (n = 6/15, 40%), or physical activity (n = 5/15, 33%). Interviews generated four main themes (n = 12): 'motivators and expectations', 'preferences and relevance', 'reinforced information", and 'wanting social support'. The intervention reinforced information, email newsletters were lengthy/challenging to read, and text messages were favoured, yet tailoring was recommended. The intervention cost AUD 11.04 per person. The mean 12-month weight was 86 ± 16 kg and 90 ± 16 kg (intervention and historical control) with no statistically significant difference. Intervention recipients enrolled at 3 months postoperatively demonstrated a statistically significant difference in 12-month weight (p = 0.014). CONCLUSION: Although this study observed high rates of recruitment and retention, findings should be considered with caution as mHealth may have been embraced more by the intervention cohort as a result of the 2019 coronavirus pandemic. Of the various digital strategies developed and tested, the text message approach was the most acceptable; however, future intervention iterations could be strengthened through tailoring information when possible. The use of email newsletters and online resources/videos requires further testing of effectiveness to determine their value for continued use in bariatric surgery services.

Police perspectives on the economic considerations of providing healthcare in short-term custodial settings in Australia.

Providing appropriate healthcare to people in short-term police custody settings (i.e. watch-houses) is challenging due to the complexity of detainee health needs and the limitations of the custodial environment. However, little is known about how detainee healthcare is managed in Australia, including economic considerations. This study had two aims: (1) to understand police perspectives on the costs associated with the delivery of healthcare to watch-house detainees in Queensland, Australia and (2) to scope the applicability of the Prison Healthcare Expenditure Reporting Checklist (PHERC) tool for the Australian watch-house context. The study employed an exploratory qualitative descriptive approach. A purposive sample comprised 16 watch-house staff from six regions in Queensland, Australia, interviewed between April and November 2021. A key finding was that police viewed healthcare expenditure as a major, but largely unavoidable cost for Australian watch-houses. Participants reported that direct expenditure comprised mostly of in-house healthcare services (of which there were a variety of models), but also costs of medication and health-related consumables. Indirect costs included costs of escorting and guarding detainees requiring transfer to hospital for health assessment and treatment. Participants reported that the PHERC was not applicable to the Australian watch-house context. Future research should explore the cost-effectiveness of different watch-house healthcare delivery models and how best to measure this.

RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice.

BACKGROUND: Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationally yet is not recommended for most people. Long-term use is associated with adverse effects including weight gain, sexual dysfunction, lethargy, emotional numbing and increased risk of falls and fractures. This study aims to determine the effectiveness of two multi-strategy interventions (RELEASE and RELEASE+) in supporting the safe cessation of long-term antidepressants, estimate cost-effectiveness, and evaluate implementation strategies. METHODS: DESIGN: 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1. SETTING: primary care general practices in southeast Queensland, Australia. POPULATION: adults 18 years or older taking antidepressants for longer than 1 year. Practices will be randomised on a 1.5:1:1 ratio of Usual care:RELEASE:RELEASE+. INTERVENTION: RELEASE for patients includes evidence-based information and resources and an invitation to medication review; RELEASE for GPs includes education, training and printable resources via practice management software. RELEASE+ includes additional internet support for patients and prescribing support including audit and feedback for GPs. OUTCOME MEASURES: the primary outcome is antidepressant use at 12 months self-reported by patients. Cessation is defined as 0 mg antidepressant maintained for at least 2 weeks. SECONDARY OUTCOMES: at 6 and 12 months are health-related quality of life, antidepressant side effects, well-being, withdrawal symptoms, emotional numbing, beliefs about antidepressants, depressive symptoms, and anxiety symptoms; and at 12 months 75% reduction in antidepressant dose; aggregated practice level antidepressant prescribing, and health service utilisation for costs. SAMPLE SIZE: 653 patients from 28 practices. A concurrent evaluation of implementation will be through mixed methods including interviews with up to 40 patients and primary care general practitioners, brief e-surveys, and study administrative data to assess implementation outcomes (adoption and fidelity). DISCUSSION: The RELEASE study will develop new knowledge applicable internationally on the effectiveness, cost-effectiveness, and implementation of two multi-strategy interventions in supporting the safe cessation of long-term antidepressants to improve primary health care and outcomes for patients. TRIAL REGISTRATION: ANZCTR, ACTRN12622001379707p. Registered on 27 October 2022.

Valuing the Dental Caries Utility Index in Australia.

INTRODUCTION: The Dental Caries Utility Index (DCUI) is a new oral health-specific health state classification system for adolescents, consisting of 5 domains: pain/discomfort, difficulty eating food/drinking, worried, ability to participate in activities, and appearance. Each domain has 4 response levels. This study aims to generate an Australian-specific utility algorithm for the DCUI. METHODS: An online survey was conducted using a representative sample of the adult Australian general population. The discrete choice experiment (DCE) was used to elicit the preferences on 5 domains. Then, the latent utilities were anchored onto the full health-dead scale using the visual analogue scale (VAS). DCE data were modeled using conditional logit, and 2 anchoring procedures were considered: anchor based on the worst health state and a mapping approach. The optimal anchoring procedure was selected based on the model parsimony and the mean absolute error (MAE). RESULTS: A total of 995 adults from the Australian general population completed the survey. The conditional logit estimates on 5 dimensions and levels were monotonic and statistically significant, except for the second level of the "worried" and "appearance" domains. The mapping approach was selected based on a smaller MAE between the 2 anchoring procedures. The Australian-specific tariff of DCUI ranges from 0.1681 to 1. CONCLUSION: This study developed a utility algorithm for the DCUI. This value set will facilitate utility value calculations from the participants' responses for DCUI in economic evaluations of dental caries interventions targeted for adolescents. HIGHLIGHTS: Preference-based quality-of-life measures (PBMs), which consist of a health state classification system and a set of utility values (a scoring algorithm), are used to generate utility weights for economic evaluations.This study is the first to develop an Australian utility value set for the Dental Caries Utility Index (DCUI), a new oral health-specific classification system for adolescents.The availability of a utility value set will enable using DCUI in economic evaluations of oral health interventions targeted for adolescents and may ultimately lead to more effective and efficient planning of oral health care services.

Midline Compared With Peripheral Intravenous Catheters for Therapy of 4 Days or Longer in Pediatric Patients: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) frequently fail during treatment causing therapy interruption, pain, recatheterization, and additional health care costs. Midline catheters (MCs) may improve functional dwell time and reduce failure compared with traditional PIVCs. Objective: To compare device failure of MCs with PIVCs. Design, Setting, and Participants: This was a pragmatic, randomized clinical superiority trial with an embedded internal pilot study conducted from July 2020 to May 2022. The study took place in a quaternary pediatric hospital in Brisbane, Queensland, Australia. Inclusion criteria were patients aged 1 to 18 years requiring peripherally compatible intravenous therapy for 4 days or longer. Interventions: Patients were randomly assigned 1:1 to receive a PIVC or MC, stratified by age (≤5 years, >5 years). One catheter was studied per patient. Main Outcomes and Measures: The primary outcome was all-cause device failure, defined as premature cessation of device function. Secondary outcomes included number of insertion attempts, insertion failure, pain (on insertion), procedural time, patient/parent satisfaction (with insertion), device dwell time, device complications during dwell time, additional vascular access devices required to complete treatment, clinician satisfaction (at removal), and health care costs. Results: Of the 128 patients randomly assigned to study groups, 127 patients (median [IQR] age, 7 [2-13] years; 71 male [56%]) had a device inserted, with 65 (51.2%) in the PIVC group and 62 (48.8%) in the MC group. All patients were included in the intention-to-treat analysis. Device failure was lower in patients in the MC group (10 [16.1%]) compared with those in the PIVC group (30 [46.2%]; odds ratio [OR], 0.22; 95% CI, 0.10-0.52; P <.001). MCs were associated with fewer insertion attempts (mean difference [MD], -0.3; 95% CI, -0.5 to 0; P = .04), increased dwell time (MD, 66.9 hours; 95% CI, 36.2-97.5 hours; P <.001), and fewer patients required additional vascular access devices to complete treatment in the MC group (4 [6.5%]) and PIVC group (19 [29.2%]; OR, 0.17; 95% CI, 0.05-0.52; P = .002). Compared with PIVCs, use of MCs was associated with greater patient (9.0 vs 7.1 of 10; P = .002) and parent (9.1 vs 8.2 of 10; P = .02) satisfaction and lower health care costs (AUS -$151.67 [US -$101.13] per person; 95% credible interval, AUS -$171.45 to -$131.90 [US -$114.20 to -$87.95]). Conclusions and Relevance: Findings suggest that MC insertion for patients requiring peripherally compatible intravenous therapy for 4 days or longer should be prioritized to reduce the resource intensive, expensive, and burdensome sequelae of device failure. Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12620000724976.

An overview of reproductive carrier screening panels for autosomal recessive and/or X-linked conditions: How much do we know?

BACKGROUND & AIM: Reproductive carrier screening seeks to identify couples at a high risk of having offspring affected by autosomal recessive and X-linked (XL) conditions. The aim of this paper is to provide a comprehensive overview of existing carrier screening panels by examining their gene content and characteristics, identifying the most common genes/conditions included in these panels, and analyzing their listed prices. METHODS: A comprehensive evaluation of existing carrier screening panels was conducted by searching for web-based content, reviewing information brochures, and establishing direct contact with the providers via email or phone. RESULTS: Twenty-two panels and their providers were identified with a cumulative total of 2205 unique genes. The number of genes included in these panels varied from 44 to 2054. Only 15 genes (0.7%) were included in all the panels. The carrier frequency of these 15 common genes and their associated conditions varied greatly, but the conditions associated with the genes are "severe". The price of these 22 panels ranged from $349 to $4320 per couple (USD in 2023). The correlation between the listed price and the number of selected genes among these panels was small and not statistically significant (r = 0.1023, p = 0.6959). CONCLUSION: Considerable discrepancies exist among carrier screening panels. Ongoing research and monitoring are necessary to capture the dynamic nature of the carrier screening landscape, providing up-to-date information for clinical practice and informed decision-making.

Activating pharmacists to reduce the frequency of medication-related problems (ACTMed): a stepped wedge cluster randomised trial.

BACKGROUND: Medicines are the most frequent health care intervention type; their safe use provides significant benefits, but inappropriate use can cause harm. Systemic primary care approaches can manage serious medication-related problems in a timely manner. OBJECTIVES: ACTMed (ACTivating primary care for MEDicine safety) uses information technology and financial incentives to encourage pharmacists to work more closely with general practitioners to reduce the risk of harm, improve patients' experience of care, streamline workflows, and increase the efficiency of medical care. METHODS AND ANALYSIS: The stepped wedge cluster randomised trial in 42 Queensland primary care practices will assess the effectiveness of the ACTMed intervention. The primary outcome will be the proportion of people at risk of serious medication-related problems - patients with atrial fibrillation, heart failure, cardiovascular disease, type 2 diabetes, or asthma or chronic obstructive pulmonary disease - who experience such problems. We will also estimate the cost per averted serious medication-related problem and the cost per averted potentially preventable medication-related hospitalisation. ETHICS APPROVAL: The University of Queensland Human Research Ethics Committee approved the pilot (2021/HE002189) and trial phases of the ACTMed study (2022/HE002136). Access to Patron data was granted by the Patron Data Governance Committee (PAT052ACTMed). Access to linked hospitalisations and deaths data are subject to Public Health Act approval (pending). DISSEMINATION OF FINDINGS: A comprehensive dissemination plan will be co-developed by the researchers, the ACTMed steering committee and consumer advisory group, project partners, and trial site representatives. Aboriginal and Torres Strait Islander communities will be supported in leading community-level dissemination. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (pilot: ACTRN12622000595718; 21 April 2022; full trial: ACTRN12622000574741; 14 April 2022).