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A double-blind, crossover, non-inferiority randomised controlled trial where primary care providers and patients compare human-generated and AI-generated digital health messages: the AI-CARE study protocol

Por: Lemieux · A. · Kutcher · S. A. · Galani Tietcheu · B. R. · Seitz · G. · Trickovic · J. · Archibald · D. · Grosjean · S. · Hogg · W. · Johnston · S.
Introduction

Primary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing artificial intelligence (AI)-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as non-inferior compared with those created by human experts.

Methods and analysis

The AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomised controlled trial. Data collection began on 30 May 2025, and is expected to be completed at the end of May 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAI’s ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages’ quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap (Research Electronic Data Capture) surveys and the order in which the 192 messages appear will be randomised and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score.

Ethics and dissemination

The Research Ethics Boards of the Hôpital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymised for dissemination in peer-reviewed scientific journals and conferences.

Trial registration number

NCT06997107.

Prevalence of and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017: a secondary analysis of data from the 2017 Aboriginal Peoples Survey

Por: DeSouza · A. · Cancelliere · C. · Hogg-Johnson · S. · Sheppard · A. J. · Taylor · D. · Ward · J. L. · Radyk · R. · Maher · J. · Garner · J. · Lynds · R. · Cote · P.
Objectives

To determine the prevalence and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017.

Design and setting

Secondary analysis of the 2017 Aboriginal Peoples Survey, a cross-sectional survey of individuals living in private dwellings throughout Canada.

Participants

First Nations people living off-reserve aged 15 years and older (n=9115; weighted n=482 066).

Outcome measure

Pain-related disabilities, defined as pain-related activity limitations lasting ≥6 months.

Results

Overall, 22.1% (95% CI 20.9% to 23.4%) of First Nations people living off-reserve reported pain-related disabilities. Prevalence was higher among females (26.1%; 95% CI (24.3% to 28.0%)), increased with age (34.3%; 95% CI (30.3% to 38.5%) among those 45 to 54 years) and was similar across geographic areas (ranging from 21.0%; 95% CI (18.3% to 23.9%) to 22.5%; 95% CI (20.8% to 24.2%)). Pain-related disabilities increased with the number of coexisting disabilities (96.2%; 95% CI (94.3% to 97.5%) among those with >3 disabilities) and was highest among those reporting physical disabilities (ranging from 88.2%; 95% CI (85.6% to 90.4%) for those with mobility disabilities to 91.0%; 95% CI (88.6% to 92.9%) for those with disability related to flexibility). Regression models suggested that individuals with unmet basic needs, housing dissatisfaction, unmet healthcare needs, a history of mental health consultations, part-time or no employment, chronic conditions, residential school attendance or a low sense of belonging were more likely to report pain-related disabilities.

Conclusions

Pain-related disabilities are common among First Nations people living off-reserve, and their aetiology may be multifactorial. Continued collaboration with Indigenous partners is required to contextualise findings and to inform culturally responsive clinical and rehabilitation strategies.

Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial

Por: Faurholt-Jepsen · M. · Dyreholt · M. S. · Kyster · N. B. · Iversen · N. · Kortsen · E. M. · Amann · B. L. · Hogg · B. · Gatto · D. · Cordoba · C. d. · Petrovic · M. · Allenhof · C. · Schnitzspahn · K. · Reich · H. · Budtz-Jorgensen · E. · Kessing · L. V. · Hegerl · U.
Introduction

Depression and sub-diagnostic depressive syndromes are prevalent and associated with suffering and reduced life expectancy. Access to care is limited even in countries with developed healthcare systems. In this context, it is important to strengthen the self-management expertise of people suffering from depressive symptoms. Smartphones offer the possibilities for improved self-management based on long-term monitoring of symptoms.

The present multicentre randomised controlled trial (the Protecting mental health in times of change (MENTINA) trial) aims to evaluate whether (1) daily smartphone-based monitoring and automatic rule-based feedback+smartphone-based outcome evaluations versus (2) smartphone-based outcome evaluations alone will improve depressive symptoms and other clinically relevant outcomes in participants with current depressive symptoms and/or one or more prior depressive episodes during a 12-month trial period.

Methods and analysis

The MENTINA trial is a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. Participants with current depressive symptoms and/or one or more previous depressive episodes are invited to participate. The included participants will be randomised to (1) daily smartphone-based monitoring and automatic rule-based feedback+outcome evaluations via smartphone (intervention group) or (2) outcome evaluations via smartphone alone (control group). All participants can continue with ongoing treatment in case they receive it. The trial started in May 2025 and has currently included 115 participants. The outcomes are differences between the intervention group and the control group in (1) Patient Health Questionnaire 9-items (PHQ-9) measured every 14th day during the 12-month trial period (primary), (2) WHO Quality of Life-BREF, Generalised Anxiety Disorder-7, monthly change in PHQ-9, proportion of participants with ≥50% reduction in PHQ-9, remission rate defined as PHQ-9≤9 and ≥5-point improvement, PHQ-9 scores after 6 months, area under the curve for PHQ-9 over the 12 months trial period, subgroup analyses in PHQ-9 in participants with or without lifetime depression, Perceived Stress Scale, user-reported healthcare contacts, usability of the app and negative effects, number of depressive episodes+duration and depressive-free days based on PHQ-9. A total of 660 participants will be included in the MENTINA trial.

Ethics and dissemination

The MENTINA trial is funded by the European Union under Grant Agreement No. 101 080 651. Ethical approval and approval from Medical Agencies have been obtained from Denmark (CIV-25-02-051094), Germany (CIV-25-02-05109) and Spain (CIV-25-02-051094). The results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patients’ organisations and media outlets.

Trial registration number

NCT06919133.

Protocol version

Version 6, January 2026.

Incidence and trends of non-fatal overdoses among people with and without HIV: a population-based cohort study in British Columbia, Canada (2012-2020)

Por: Kooij · K. W. · Marziali · M. · Budu · M. · Trigg · J. · Ye · M. · Zhang · W. · McLinden · T. · Emerson · S. D. · Salters · K. · Martins · S. S. · Montaner · J. · Hogg · R. S.
Objectives

Our study investigated the age-adjusted incidence rates of non-fatal overdoses by HIV status and sex, and examined trends over time.

Design

We used data from the Comparative Outcomes and Service Utilization Trends study, a population-based cohort study that includes clinical and administrative health data on virtually all people with HIV (PWH) and a 10% random sample of people without HIV in the province.

Setting

British Columbia, Canada.

Participants

Between April 2012 and March 2020, 11 050 PWH (81.8% male) and 473 952 people without HIV (50.3% male) who were 19 years and older contributed 68 035 and 3 285 824 person years (PY) of follow-up, respectively.

Outcome measures

The primary outcome was age-adjusted incidence rates of non-fatal overdose events stratified by sex and HIV status. Trends over time were also assessed.

Results

Age-adjusted non-fatal overdose incidence rates among males with and without HIV were 36.4 and 3.12 per 1000 PY, respectively (incidence rate ratio (IRR) = 11.7, 95% CI 10.9 to 12.5). For females with and without HIV, the age-adjusted incidence rates were 61.4 and 2.33 per 1000 PY, respectively (IRR=26.3, 95% CI 24.0 to 28.7). Between 2013 and 2019 (calendar years with full-year data), the age-adjusted non-fatal overdose rate increased significantly among males and females without HIV but not among PWH.

Conclusions

We observed a significantly higher non-fatal overdose rate among PWH compared to people without HIV. The rate was highest among females with HIV. These findings underline the need for policies and programmes oriented towards PWH to mitigate overdoses, especially for females.

Comorbidity prevalence and healthcare costs in people living with HIV compared with the general population: a 19-year retrospective cohort study in British Columbia, Canada

Por: Magee · C. · Nathani · H. · Chan · M. · Takeh · B. · Budu · M. · Kooij · K. W. · Hogg · R. S. · Guillemi · S. · Montaner · J. G. S. · Lima · V. D.
Objectives

Our objectives were (1) to characterise the age-sex-standardised prevalence of comorbidities among people living with HIV (PLWH) and people not living with HIV (PnLWH) between 2001 and 2019 and (2) to examine the effect of comorbidities on direct healthcare costs among PLWH and PnLWH.

Design

This was a retrospective, matched cohort study conducted with the Comparative Outcomes and Service Utilisation Trends (COAST) cohort, which contained all known PLWH in British Columbia (BC), Canada and a general population sample.

Setting

BC, Canada.

Participants

A total of 9554 PLWH and 47 770 PnLWH from the COAST cohort were followed between 2001 and 2019. Participants were at least 19 years old and 82% male in both groups.

Outcome measures

The primary outcomes were the age-sex-standardised prevalence of 16 comorbidities, calculated annually, among PLWH and PnLWH. Secondary outcomes included direct healthcare costs associated with each comorbidity among PLWH and PnLWH. Outcomes were ascertained from administrative health databases.

Results

PLWH exhibited a higher age-sex-standardised prevalence of most comorbidities compared with PnLWH over the study period. Relative disparities in liver and kidney diseases markedly decreased since 2008. Disparities in the prevalence of mental health disorders and substance use disorder (SUD) were consistently large throughout the study period. Comorbidities were associated with high healthcare costs, especially among PLWH.

Conclusions

This study underscores the persistent and evolving burden of non-AIDS-defining comorbidities among PLWH, even in the context of improved HIV management. The high prevalence of mental health disorders and SUD, coupled with the substantial healthcare costs associated with these conditions, emphasises the need for holistic and integrated care models that address the full spectrum of health challenges faced by PLWH.

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