METHODS: The study is a randomised double-blind placebo-controlled phase-II single-site clinical trial conducted in Perth, Australia. The target sample is to recruit 240 participants diagnosed with chronic frequent episodic migraines between 18 and 80 years of age. Participants will be randomised to one of four treatment groups for 14 weeks (placebo induction for 2 weeks, followed by 12 weeks on one of the respective treatment arms): placebo, L-arginine, AGE, or a combination of L-arginine and AGE. The doses of L-arginine and AGE are 1.5 g and 1 g daily, respectively. The primary outcome is to assess migraine response using change in migraine frequency and intensity between baseline and 12 weeks. Secondary outcomes include the impact of L-arginine and/or AGE on photosensitivity, retinal vessel changes, and blood biomarker concentrations of vascular tone, following a 12-week intervention.
DISCUSSION: The protocol describes the oral administration of 2 nutraceutical-based interventions as possible prophylactic treatments for chronic frequent episodic migraines, with potential for direct clinical translation of outcomes. Potential limitations of the study include the fixed-dose design of each treatment arm and that in vivo neuroimaging methods, such as magnetic resonance imaging (MRI), will not be conducted to determine putative cerebro-vasodilatory changes to coincide with the outcome measures. Dose-response studies may be indicated.
TRIAL REGISTRATION: The trial was retrospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12621001476820 (Universal Trial Number: U1111-1268-1117) on 04/08/2021. This is protocol version 1, submitted on 25/11/2022.
METHODS: We used digitised mammograms for 371 monozygotic twin pairs, aged 40-70 years without a prior diagnosis of breast cancer at the time of mammography, from the Australian Mammographic Density Twins and Sisters Study. We generated normalised, age-adjusted, and standardised risk scores based on textures using the Cirrus algorithm and on three spatially independent dense areas defined by increasing brightness threshold: light areas, bright areas, and brightest areas. Causal inference was made using the Inference about Causation from Examination of FAmilial CONfounding (ICE FALCON) method.
RESULTS: The mammogram risk scores were correlated within twin pairs and with each other (r = 0.22-0.81; all P
METHODS: Eight scientific databases were searched. Two independent reviewers screened the literature in title and abstract stages, followed by full-text appraisal, data extraction, and synthesis of eligible studies. Studies were extracted to capture details of the mhealth tools used, the service issues addressed, the study design, and the outcomes evaluated. We then mapped the included studies using the 20 sub-strategies of the WHO Framework on Integrated People-Centred Health Services (IPCHS); as well as with the RE-AIM (Reach, effectiveness, adoption, implementation and maintenance) framework, to understand how studies implemented and evaluated interventions.
RESULTS: We identified 39 studies, predominantly from Australia (n = 16), China (n = 7), Malaysia (n = 4) and New Zealand (n = 4), and little from low income countries. The mHealth modalities included text messaging, voice and video communication, mobile applications and devices (point-of-care, GPS, and Bluetooth). Health issues addressed included: medication adherence, smoking cessation, cardiovascular disease, heart failure, asthma, diabetes, and lifestyle activities respectively. Almost all were community-based and focused on service issues; only half were disease-specific. mHealth facilitated integrated IPCHS by: enabling citizens and communities to bypass gatekeepers and directly access services; increasing affordability and accessibility of services; strengthening governance over the access, use, safety and quality of clinical care; enabling scheduling and navigation of services; transitioning patients and caregivers between care sectors; and enabling the evaluation of safety and quality outcomes for systemic improvement. Evaluations of mHealth interventions did not always report the underlying theories. They predominantly reported cognitive/behavioural changes rather than patient outcomes. The utility of mHealth to support and improve IPCHS was evident. However, IPCHS strategy 2 (participatory governance and accountability) was addressed least frequently. Implementation was evaluated in regard to reach (n = 30), effectiveness (n = 24); adoption (n = 5), implementation (n = 9), and maintenance (n = 1).
CONCLUSIONS: mHealth can transition disease-centred services towards people-centred services. Critical appraisal of studies highlighted methodological issues, raising doubts about validity. The limited evidence for large-scale implementation and international variation in reporting of mHealth practice, modalities used, and health domains addressed requires capacity building. Information-enhanced implementation and evaluation of IPCHS, particularly for participatory governance and accountability, is also important.
METHODS: Staff involved in student support from three medical schools were invited to participate in five workshops facilitated by an Australian educator. Video discussion triggers of students presenting with concerns were used in workshop activities, including written exercises, group discussions and reflection. The quantitative and qualitative data collected included categorical and free-text participant responses to questionnaires and structured field notes from local faculty developers using peer observation.
FINDINGS: Academic and clinician-teacher participants predominated in the workshops. Of 66 participant questionnaires (92% response rate), over 90% agreed that the workshop was relevant, and over 95% agreed that the videos facilitated discussion and the sharing of experiences. Field notes confirmed that participants were engaged by the videos, but identified that one student scenario and the approaches for seeking support in others were not immediately transferable to local contexts. The adaptation of facilitation techniques used in Australian workshops was needed to address audience responses.
DISCUSSION: Our findings confirm faculty development principles of content relevancy and incorporation of reflection. To enhance transferability, we recommend co-facilitation with local faculty members, the explicit signposting of topics and re-contextualising key concepts through reflective discussion.