Search Results for: Ulcere del piede diabetico: review

Introduction
Dermoscopy has a proved validity in the diagnosis of cutaneous melanoma, which is one of the most aggressive forms of skin cancer. Although some studies have demonstrated a relationship between specific dermoscopic and pathologic melanoma features, there is no solid evidence allowing reliable conclusions. This study will evaluate the evidence regarding this association.

Methods and analysis
Observational studies eligible for our systematic review will enrol adults with histological cutaneous non-volar melanoma diagnosis and with dermoscopy image analysis. We will search the following databases: PubMed, Embase, Web of Science, MEDLINE and Cochrane Library. We will not impose any language or date restrictions. Outcomes of interest include the association of at least one of the melanoma dermoscopy features (irregular pigmentation, blue-white veil, atypical network, multicomponent pattern, atypical dots and/or globules, regression, peripheral tan structureless area, negative network, shiny white structures, atypical vessels and streaks/pseudopods), with melanoma Breslow index or other histopathology characteristics (melanoma subtype, mitotic index and presence of ulceration). Two reviewers will independently screen and search results, extract data from eligible studies and assess risk of bias. The evidence derived by this study will elucidate the possible link between melanoma dermoscopy and histopathology. If we could predict melanoma thickness based on dermoscopy, we would be able to anticipate melanoma treatment with impact on survival.

Ethics and dissemination
Ethical approval is not required because this is a literature-based study. It will be published in scientific Pubmed indexed open access journals to ensure its accessibility.

PROSPERO registration number
CRD42024564919.

Introduction
Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.

Methods
Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.

Analysis
The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.

Ethics and dissemination
The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.

Trial registration number
COMET registration number 3223.

Introduction
Differences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably Lactobacillus species, is associated with increased pregnancy chances. However, to date, limited evidence is available on the effect of active modification strategies to facilitate the modulation of the VMB profile to help restore a VMB dominated by Lactobacillus species.

Methods and analysis
This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF.

Ethics and dissemination
Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Trial registration number
CCMO NL81210.068.22, registered 25 September 2023.

Introduction
The experimental EuroQol Toddler and Infant Populations (EQ-TIPS) instrument is currently under development as a health-related quality of life (HRQoL) measure for toddlers and infants aged 0–36 months. Using this protocol, researchers can conduct surveys with discrete choice experiments (DCEs) that examine the key properties of HRQoL instruments, specifically whether severity aligns with preferences across each attribute and the extent to which attributes influence choices. To demonstrate this protocol, we will conduct two waves of DCE surveys using different choice tasks and a common scenario (a 1-month health episode for a 1-year-old child).

Methods and analysis
In the first wave (a general population sample of 400 Australian adults; 14 kaizen tasks each), respondents will view a single EQ-TIPS-five-level (v3.0) profile for each task and be asked to make a series of choices that sequentially alleviate the child’s health problems. Using this exploratory evidence, we will assess whether EQ-TIPS severity aligns with preferences and the extent to which each attribute level influences choices (ie, main effects). In the second wave (1000 Australian adults; 28 paired comparisons), respondents will see two EQ-TIPS profiles for each task and be asked to choose between them. Using this confirmatory evidence, we will compare the main effects and their uncertainty by wave. For each DCE, we will estimate a main-effects conditional logit model and test for differences in effects using cluster bootstrap techniques. As sensitivity analyses, we will evaluate the effects of task sequence, attribute order and sample size on uncertainty in each wave.

Ethics and dissemination
The independent review board at Includovate evaluated the application for ethical clearance and approved the study on 19 February 2025. To disseminate our findings, we will prepare multiple manuscripts for publication in peer-reviewed journals and present highlights at scientific meetings, such as the EuroQol Plenary Meeting and the International Academy of Health Preference Research.

Introduction
Artemisinin-based combination therapies (ACTs) remain the WHO-recommended treatment for uncomplicated Plasmodium falciparum malaria. However, the emergence and spread of artemisinin resistance (ART-R) threatens ACT efficacy. ART-R is phenotypically expressed as delayed parasite clearance, which can facilitate ACT partner drug resistance. ART-R has been causally linked to specific mutations in the Pfkelch13 gene.

Methods and analysis
The systematic review and associated meta-analysis aim to determine the correlation between Pfkelch13 (alleles present in the Kelch13 gene region of the P. falciparum parasite) genotypes and clinical and parasitological response to ACTs from a globally representative data set pooling individual patient data (IPD) from eligible published and unpublished studies. The eligibility criteria include Pfkelch13 genotyping results at baseline complemented by individually linked parasitological and clinical assessments following artemisinin-based treatment. The data will be curated, standardised and analysed using this proposed statistical analysis plan (SAP), adhering to PRISMA-IPD (PRISMA, Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Our SAP will apply hierarchical modelling to assess the effect of the P. falciparum parasite Pfkelch13 mutations on parasite clearance half-life and therapeutic efficacy across different regions. This will include study sites as random effects in the model and potential predictors such as age, sex, baseline parasite load and other potential effect modifiers as fixed effects. This analysis will enhance the understanding of the influence of Pfkelch13 mutations on malaria treatment outcomes.

Ethics and dissemination
Data were obtained with informed consent and ethical approvals from the relevant countries and were pseudonymised before curation in the Infectious Diseases Data Observatory (IDDO)/WorldWide Antimalarial Resistance Network (WWARN) repository. Data ownership remains with contributors. This IPD meta-analysis met the Oxford Tropical Research Ethics Committee criteria for waiving ethical review, as it is a secondary analysis of existing pseudonymised data. The resulting peer-reviewed publication and conference proceedings will help strengthen and enhance the efficiency of ART-R surveillance and response and support policy decisions.

PROSPERO registration number
CRD42019133366.

Introduction
Pre-eclampsia (PEC) is a morbid and potentially lethal complication of pregnancy and is more common in women with risk factors such as hypertension, diabetes, autoimmune disease, kidney disease or multifetal pregnancies. Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. In the USA, the currently available low-dose ASA is over-the-counter and found in 81 mg tablets. Therefore, when clinicians initiate low-dose ASA therapy, they may prescribe one or two tablets of 81 mg per day without comparative evidence to guide their decision. Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.

Methods and analysis
We designed a pragmatic phase 3 prospective randomised open label blinded-end point clinical trial with parallel assignment between two groups of pregnant people at high risk for PEC, as defined by the US Preventive Services Task Force and American College of Obstetricians and Gynecologists (ACOG). The primary outcome is the incidence of preterm (

Objectives
Women with severe mental illness (SMI) face barriers to cervical cancer screening, leading to lower participation and poorer outcomes. This research aimed to develop and test an informed-choice tool to help women with SMI make informed decisions about screening attendance.

Design
The tool was developed using a realist review of physical health interventions and a systematic review of informed-choice tools for people with SMI. A mixed-methods approach informed its development. Usability and acceptability were assessed through semistructured interviews and the think-aloud method with service users (n=18), clinicians (n=16) and key informants. A preliminary proof-of-concept (n=25) evaluated the impact on decisional conflict—the uncertainty around making value-sensitive choices.

Setting and participants
Conducted in two National Health Service (NHS) Mental Health Trusts (urban and rural). Participants included women with SMI accessing secondary mental healthcare, clinicians and service user groups. A key informants’ group guided clinical content.

Intervention
A cervical screening informed-choice leaflet and an accompanying video.

Results
The tool was usable and acceptable, especially for women overdue or never screened. It may reduce decisional conflict and increase screening uptake, potentially improving survival. An National Institute for Health and Care Research (NIHR)-funded feasibility trial (Improving uptake of cervical screening in people with severe mental illness (OPTMISE)) is underway. The current UK government guidance on Support for people who find it hard to attend cervical screening due to having a mental health condition or having experienced trauma or abuse is based on this research.

Conclusions
Future research may involve further assessments of the real-world impact of the tool and its adaptation to other health-related decisions.

Introduction
The global population of individuals aged 60 years and older is growing rapidly, presenting multiple complex challenges, including frailty, cognitive decline, functional impairments, multimorbidity and polypharmacy. Consequently, addressing the rehabilitation needs of this age group poses significant difficulties in today’s world. There is some evidence that community-based rehabilitation approaches can meet the unique rehabilitation needs of older individuals. Therefore, this scoping review aims to explore the application of community-based rehabilitation approaches for the older adult population.

Methods and analysis
This scoping review will follow the methodological framework outlined by Arksey and O’Malley. The search will be conducted using academic databases, including PubMed, ScienceDirect, Embase, CINAHL and Web of Science, with the search terms ‘community-based rehabilitation,’ ‘aged,’ ‘older,’ ‘elder’ and ‘geriatric’. Additionally, Google Scholar will be used to identify relevant literature. Publications in English from inception to January 2025 that explicitly address community-based rehabilitation programmes for older adults will be eligible. Inclusion criteria encompass studies reporting on CBR interventions, outcomes or implementation targeting older adults with disabilities or vulnerabilities, across diverse geographic and socioeconomic contexts. Both peer-reviewed articles and grey literature (eg, reports, guidelines, theses) will be considered. Studies focusing solely on clinical or institutional rehabilitation without community components will be excluded. The study selection process will occur in two stages, involving the participation of three reviewers. A data extraction form will be used to systematically extract data from all included studies.

Ethics and dissemination
This scoping review was approved by the Ethics Committee of the University of Social Welfare and Rehabilitation Sciences (Code:IR.USWR.REC.1404.034), and the results will be published in a peer-reviewed scientific journal.

Our findings indicate that TT may benefit patients with newly diagnosed TP53m MCL, and Allo-HSCT, CAR-T cell therapy, or TT could be considered for relapsed/refractory cases. However, -suboptimal long-term survival highlights the urgent need for innovative therapies. Key limitations, including small sample sizes and few randomised controlled trials (RCTs), emphasize the need for well-designed RCTs with adequate sample size in this field.

Introduction
Histopathological evaluation of prostate biopsies using the Gleason scoring system is critical for prostate cancer diagnosis and treatment selection. However, grading variability among pathologists can lead to inconsistent assessments, risking inappropriate treatment. Similar challenges complicate the assessment of other prognostic features like cribriform cancer morphology and perineural invasion. Many pathology departments are also facing an increasingly unsustainable workload due to rising prostate cancer incidence and a decreasing pathologist workforce coinciding with increasing requirements for more complex assessments and reporting. Digital pathology and artificial intelligence (AI) algorithms for analysing whole slide images show promise in improving the accuracy and efficiency of histopathological assessments. Studies have demonstrated AI’s capability to diagnose and grade prostate cancer comparably to expert pathologists. However, external validations on diverse data sets have been limited and often show reduced performance. Historically, there have been no well-established guidelines for AI study designs and validation methods. Diagnostic assessments of AI systems often lack preregistered protocols and rigorous external cohort sampling, essential for reliable evidence of their safety and accuracy.

Methods and analysis
This study protocol covers the retrospective validation of an AI system for prostate biopsy assessment. The primary objective of the study is to develop a high-performing and robust AI model for diagnosis and Gleason scoring of prostate cancer in core needle biopsies, and at scale evaluate whether it can generalise to fully external data from independent patients, pathology laboratories and digitalisation platforms. The secondary objectives cover AI performance in estimating cancer extent and detecting cribriform prostate cancer and perineural invasion. This protocol outlines the steps for data collection, predefined partitioning of data cohorts for AI model training and validation, model development and predetermined statistical analyses, ensuring systematic development and comprehensive validation of the system. The protocol adheres to Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis+AI (TRIPOD+AI), Protocol Items for External Cohort Evaluation of a Deep Learning System in Cancer Diagnostics (PIECES), Checklist for AI in Medical Imaging (CLAIM) and other relevant best practices.

Ethics and dissemination
Data collection and usage were approved by the respective ethical review boards of each participating clinical laboratory, and centralised anonymised data handling was approved by the Swedish Ethical Review Authority. The study will be conducted in agreement with the Helsinki Declaration. The findings will be disseminated in peer-reviewed publications (open access).

Background
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

Methods
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

Ethics and dissemination
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Trial registration numbers
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

Introduction
Effective health management is critical for patients with tuberculosis (TB), especially given the need for long-term treatment adherence and continuous monitoring. Artificial intelligence (AI)-assisted remote health management services offer a promising solution to increase patient engagement, optimise follow-up and improve treatment outcomes. However, little research has explored TB patients’ preferences for these services, and no discrete choice experiment (DCE) has systematically investigated how they make trade-offs between different service attributes. This study aims to (1) identify key attributes of AI-assisted remote health management services that influence TB patients’ choices, (2) assess how patients with TB evaluate trade-offs between different service options using a DCE and (3) examine whether preferences vary by sociodemographic characteristics and health system factors.

Methods and analysis
Six attributes were identified through a literature review, focus group discussions and expert consultations. A fractional factorial design was used to generate choice sets while maintaining statistical efficiency and minimising respondent burden. The DCE will be analysed using a multinomial logit model to estimate average preferences. A mixed logit model will be applied to explore preference heterogeneity among participants, incorporating interaction terms with sociodemographic and attitudinal variables. Stratified and latent class analyses will also be considered to further investigate sources of heterogeneity.

Ethics and dissemination
This study complies with the Declaration of Helsinki and has been approved by the Ethics Committee of Wuhan Pulmonary Hospital. All participant data will remain anonymous, and individuals may withdraw from the study at any time. The findings will inform the development of patient-centred AI-assisted TB management strategies and contribute to broader policy discussions on AI integration in TB care. The results will be disseminated through peer-reviewed journal publications, policy briefs, conferences and online platforms.

Introduction
Globally, drug shortages affect low-, middle- and high-income countries to different degrees. The challenges associated with drug shortages in health systems, particularly in public health facilities, and the consequent multiple adverse effects on patients and the health systems have led countries to continue to explore and implement different strategies to combat this challenge. Various factors implicated in drug shortages range from manufacturing concerns, demand issues, supply chain disruptions and regulatory issues. The effects of drug shortages in health systems range from poor patient compliance and therapeutic failure to antimicrobial resistance, low morale among healthcare workers and public distrust in government services. Furthermore, the effects of drug shortages in public health facilities include unavailability of drugs to patients, hospitalisation and readmissions, and associated costs that could be avoided, high out-of-pocket expenditures suffered by patients as patients resort to buying drugs from private pharmacies where the prices are usually exorbitant and prohibitive, putting patients at risk of treatment default due to lack of affordability. Successful mitigation strategies deployed to prevent and manage drug shortages in sub-Saharan Africa (SSA) remain unshared despite the potential of these strategies to serve as valuable lessons if the evidence is scientifically synthesised and reported. The scoping review will synthesise evidence to provide policy guidance for better planning of health services and resources, resulting in improved quality of life for citizens, underscoring the importance of functional and responsive health systems.

Methods and analysis
Using the Joanna Briggs Institute (JBI) scoping review methodology, a five-stage review is outlined: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. The literature search will use PubMed, SCOPUS and the Elsevier Science Direct search interfaces, reflecting empirical and grey literature. We will focus on literature published between 2000 and 2025. The study start and end dates are 1 September–30 November 2025. A two-stage screening process will be used to determine the eligibility of articles. All articles will be individually assessed for eligibility by two reviewers, while a third reviewer will resolve any disagreements. The data from eligible articles will be extracted and charted using a standardised form. Extracted data will be analysed using narrative and descriptive analyses.

Ethics and dissemination
Ethical approval is not required for this scoping review as it will use only previously published data. It does not require human participation. The results of this search will be disseminated through academic presentations at conferences and peer-reviewed publications.

Introduction
Social media sites are increasingly used to assess and treat different mental health problems in adolescents and young adults. However, it is still unclear which social network sites are the most used for this purpose and what interventions for tackling unhealthy body image have been validated. This systematic review will assess evidence on the effectiveness of social media interventions in improving unhealthy body image among adolescents and young adults.

Methods and analysis
Five databases, including Embase, Scopus, MEDLINE, Web of Science (Core Collection) and PsycINFO, will be consulted, with a publication window starting in 2011 and ending on 31 October 2024. Rayyan software will detect and eliminate duplicates. We will include only studies based on social media-based interventions for adolescents and young adults with body image problems. Two independent reviewers will screen titles, abstracts and full-text articles, resolving conflicts through discussion with a third reviewer as needed. The two reviewers will complete the risk of bias assessments for each included study, using the Joanna Briggs Institute critical appraisal checklists for randomised controlled trials and quasi-experimental studies. We will report on the characteristics of studies, participants and interventions in descriptive narrative form, along with the results from the assessment of social media interventions.

Ethics and dissemination
Universidad Cesar Vallejo’s ethics committee approved this systematic review protocol as part of a wider project (code 100-CEI-EPM-UCV-2022). Results will be shared via social media to engage stakeholders and promote awareness of body image issues.

Objectives
Fertility therapies are becoming an increasingly common option for conception, but there is little knowledge on the interactions of assisted reproductive technology (ARTs) and stroke in women, and its use among women with a history of stroke. This scoping review aims to examine the current state of knowledge and identify the knowledge gaps regarding: (1) the stroke risk with use of fertility therapy and (2) the safety of fertility therapy among stroke survivors, to help guide future research and clinical practice.

Design
The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist for scoping reviews was followed.

Data sources
MEDLINE (Ovid), Cochrane Central Registry of Controlled Trials (Ovid), EMBASE (Ovid), Medline, ClinicalTrials.gov and International Clinical Trials Registry Platform were searched through 20 June 2023.

Eligibility criteria for selecting studies
All observational studies pertaining to use of fertility and stroke in humans over the age of 18 were included in this review.

Data extraction and synthesis
Title and abstract and subsequent full-text review were performed by two independent reviewers in duplicate. A narrative synthesis of final articles for data abstraction is presented.

Results
10 studies met inclusion criteria. The only meta-analysis that was included could not estimate the risk of stroke among all individuals undergoing fertility therapy due to lack of high-quality prospective cohort studies. There was only one prospective cohort that examined pregnancy among stroke survivors. Among the 32 pregnancies, one was conceived through in vitro fertilisation (IVF), although the details regarding stroke type, time since stroke, medications and IVF protocol were not specified. Therefore, the safety and effectiveness of ART among stroke survivors is currently unknown.

Conclusion
In this comprehensive review of existing fertility therapy science and stroke risk, we identify a large knowledge gap and a major scientific need for a systematic approach and prospective studies to better inform the risk of stroke during fertility therapy, especially among stroke survivors. Understanding this risk and developing treatment strategies serves to better inform women and healthcare providers as more women with a history of stroke seek and contemplate fertility therapy.

Trial registration number
DOI 10.17605/OSF.IO/PHQ4X

Introduction
Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.

Methods and analysis
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.

Ethics and dissemination
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.

Trial registration number
ACTRN12624001409561.