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Defining acceptable data collection and reuse standards for queer artificial intelligence research in mental health: protocol for the online PARQAIR-MH Delphi study

Por: Joyce · D. W. · Kormilitzin · A. · Hamer-Hunt · J. · McKee · K. R. · Tomasev · N.
Introduction

For artificial intelligence (AI) to help improve mental healthcare, the design of data-driven technologies needs to be fair, safe, and inclusive. Participatory design can play a critical role in empowering marginalised communities to take an active role in constructing research agendas and outputs. Given the unmet needs of the LGBTQI+ (Lesbian, Gay, Bisexual, Transgender, Queer and Intersex) community in mental healthcare, there is a pressing need for participatory research to include a range of diverse queer perspectives on issues of data collection and use (in routine clinical care as well as for research) as well as AI design. Here we propose a protocol for a Delphi consensus process for the development of PARticipatory Queer AI Research for Mental Health (PARQAIR-MH) practices, aimed at informing digital health practices and policy.

Methods and analysis

The development of PARQAIR-MH is comprised of four stages. In stage 1, a review of recent literature and fact-finding consultation with stakeholder organisations will be conducted to define a terms-of-reference for stage 2, the Delphi process. Our Delphi process consists of three rounds, where the first two rounds will iterate and identify items to be included in the final Delphi survey for consensus ratings. Stage 3 consists of consensus meetings to review and aggregate the Delphi survey responses, leading to stage 4 where we will produce a reusable toolkit to facilitate participatory development of future bespoke LGBTQI+–adapted data collection, harmonisation, and use for data-driven AI applications specifically in mental healthcare settings.

Ethics and dissemination

PARQAIR-MH aims to deliver a toolkit that will help to ensure that the specific needs of LGBTQI+ communities are accounted for in mental health applications of data-driven technologies. The study is expected to run from June 2024 through January 2025, with the final outputs delivered in mid-2025. Participants in the Delphi process will be recruited by snowball and opportunistic sampling via professional networks and social media (but not by direct approach to healthcare service users, patients, specific clinical services, or via clinicians’ caseloads). Participants will not be required to share personal narratives and experiences of healthcare or treatment for any condition. Before agreeing to participate, people will be given information about the issues considered to be in-scope for the Delphi (eg, developing best practices and methods for collecting and harmonising sensitive characteristics data; developing guidelines for data use/reuse) alongside specific risks of unintended harm from participating that can be reasonably anticipated. Outputs will be made available in open-access peer-reviewed publications, blogs, social media, and on a dedicated project website for future reuse.

Cost-effectiveness of the top 100 drugs by public spending in Canada, 2015-2021: a repeated cross-sectional study

Por: Gaudette · E. · Rizzardo · S. · Zhang · Y. · Pothier · K. R. · Tadrous · M.
Objectives

To assess the distribution and spending by cost-effectiveness category among those drugs with the highest public spending levels in Canada.

Design

Repeated cross-sectional study.

Setting

The Canadian provinces of Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland.

Main outcomes and measures

Cost-effectiveness assessments by the Canadian Agency for Drugs and Technologies in Health (CADTH) for top-100 brand-name outpatient drugs by gross public plan spending in any year between 2015 and 2021 in Canada Institute for Health Information’s National Prescription Drug Utilization Information System data. Gross public plan spending by cost-effectiveness category.

Results

From 2015 to 2021, 152 brand-name drugs occupied a top-100 rank and were included in the analysis. Of those, 117 had been assessed by CADTH. During the 7-year period, there was an increase in both top-100 drugs with cost-effective (from 18 to 24) and cost-ineffective (from 29 to 41) assessments, while drugs not assessed or with an unclear assessment declined (from 31 to 19 and from 22 to 16, respectively). As a share of spending on top-100 drugs with an assessment, spending on cost-effective drugs was mostly stable at 40%–46% from 2015 to 2021, while spending on cost-ineffective drugs increased from 30% to 45%.

Conclusion

A large and growing share of public drug spending has been allocated to cost-ineffective drugs in Canada. Dedicating large budgets to such treatments prevents spending with greater health impact elsewhere in the healthcare system and could restrain the capacity to pay for groundbreaking pharmaceutical innovation in the future.

Biomechanical and neuromuscular characteristics in patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair: a clinical prospective cohort study protocol

Por: Malmberg · C. · Andreasen · K. R. · Bencke · J. · Kjaer · B. H. · Holmich · P. · Barfod · K. W.
Introduction

Traumatic shoulder dislocation is a common shoulder injury, especially among the young and active population. More than 95% of dislocations are anterior, in which the humeral head is forced beyond the anterior glenoid rim. The injury leads to increased joint laxity and recurrence rates are high. There is evidence that the shoulder biomechanics and neuromuscular control change following dislocation, but the existing literature is scarce, and it remains to be established if and how these parameters are useful in the clinical setting. The aim of this exploratory prospective cohort study is to investigate biomechanical and neuromuscular outcomes in patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair, to test the hypothesis that examinations of these characteristics are applicable in the clinical setting to assess shoulder instability.

Methods and analysis

This is a prospective multicentre cohort study with repeated measures of 30 patients undergoing arthroscopic Bankart repair. With carefully selected and completely non-invasive examination methods, we will investigate biomechanical and neuromuscular outcomes in the affected shoulders once presurgically and twice post surgically at 6 and 12 months. Patients’ contralateral shoulders are investigated once to establish a preinjury level.

Ethics and dissemination

The study was approved by the Capital Region Ethics Committee (journal-no: H-21027799) and the Capital Region Knowledge Center for Data Reviews (journal-no: P-2021-842) before patient recruitment began. The study results will be published in international peer-reviewed journals, online and in other relevant media, presented at medical conventions and disseminated to clinicians and patients as appropriate.

Trial registration number

NCT05250388.

Older adults attitudes towards deprescribing and medication changes: a longitudinal sub-study of a cluster randomised controlled trial

Por: Jungo · K. T. · Weir · K. R. · Cateau · D. · Streit · S.
Objective

To investigate the association between older patients’ willingness to have one or more medications deprescribed and: (1) change in medications, (2) change in the appropriateness of medications and (3) implementation of prescribing recommendations generated by the electronic decision support system tested in the ‘Optimising PharmacoTherapy In the Multimorbid Elderly in Primary CAre’ (OPTICA) trial.

Design

A longitudinal sub-study of the OPTICA trial, a cluster randomised controlled trial.

Setting

Swiss primary care settings.

Participants

Participants were aged ≥65 years, with ≥3 chronic conditions and ≥5 regular medications recruited from 43 general practitioner (GP) practices.

Exposures

Patients’ willingness to have medications deprescribed was assessed using three questions from the ‘revised Patient Attitudes Towards Deprescribing’ (rPATD) questionnaire and its concerns about stopping score.

Measures/analyses

Medication-related outcomes were collected at 1 year follow-up. Aim 1 outcome: change in the number of long-term medications between baseline and 12 month follow-up. Aim 2 outcome: change in medication appropriateness (Medication Appropriateness Index). Aim 3 outcome: binary variable on whether any prescribing recommendation generated during the OPTICA medication review was implemented. We used multilevel linear regression analyses (aim 1 and aim 2) and multilevel logistic regression analyses (aim 3). Models were adjusted for sociodemographic variables and the clustering effect at GP level.

Results

298 patients completed the rPATD, 45% were women and 78 years was the median age. A statistically significant association was found between the concerns about stopping score and the change in the number of medications over time (per 1-unit increase in the score the average number of medications use was 0.65 higher; 95% CI: 0.08 to 1.22). Other than that we did not find evidence for statistically significant associations between patients’ agreement with deprescribing and medication-related outcomes.

Conclusions

We did not find evidence for an association between most measures of patient agreement with deprescribing and medication-related outcomes over 1 year.

Trial registration number

NCT03724539.

Feasibility of a pregnancy intervention mimicking viral transmission mitigation measures on the incidence of preterm birth in high-risk pregnant women enrolled in antenatal clinics in Melbourne, Australia: protocol for a pilot, randomised trial

Por: Sridhar · S. · Mol · B. W. · Hodges · R. · Palmer · K. R. · Sundram · S. · de Carvalho Pacagnella · R. · Souza · R. T. · Barbosa-Junior · F. · Mackin · D. · Said · J. · Rolnik · D. · Malhotra · A.
Introduction

Preterm birth is a leading cause of perinatal morbidity and mortality. During the COVID-19 pandemic, reduction in rates of preterm birth in women exposed to viral mitigation measures was reported by multiple studies. In addition, others and we observed a more pronounced reduction of preterm birth in women who had previously experienced a preterm birth. The aim of this pilot study is to establish the feasibility of a lifestyle intervention based on viral mitigation measures in high-risk pregnancies, with the ultimate aim to reduce the incidence of preterm birth.

Methods and analysis

One hundred pregnant women, enrolled in antenatal clinics at two tertiary maternity centres in Melbourne, Australia, who have had a previous preterm birth between 22 and 34 weeks gestation will be recruited. This is a two-arm, parallel group, open-label randomised controlled feasibility trial: 50 women will be randomised to the intervention group, where they will be requested to comply with a set of lifestyle changes (similar to the viral mitigation measures observed during the pandemic). Another 50 women will be randomised to the control group, where they will undergo standard pregnancy care. The primary outcome of this trial is feasibility, which will be assessed by measuring patient eligibility rate, recruitment rate, compliance rate and data completion rate. Secondary outcomes include incidence of preterm birth, maternal satisfaction, maternal quality of life and other pregnancy outcomes. Standard methods in statistical analysis for randomised controlled trials on an intention to treat basis will be followed.

Ethics and dissemination

This trial has been approved by the Monash Human Research Ethics Committee; approval reference number RES-22-0000-122A. Study findings will be reported and submitted to peer-reviewed journals for publication, and presentation at conferences.

Trial registration number

ACTRN12622000753752; Pre-results.

Adverse COVID-19 outcomes in American Veterans with age-related macular degeneration: a case-control study

Por: Armbrust · K. R. · Westanmo · A. · Gravely · A. · Chew · E. Y. · van Kuijk · F. J.
Objectives

Prior studies suggest that patients with age-related macular degeneration (AMD) have poorer COVID-19 outcomes. This study aims to evaluate whether AMD is associated with adverse COVID-19 outcomes in a large clinical database.

Design

Case–control study.

Setting

We obtained demographic and clinical data from a national US Veterans Affairs (VA) database for all Veterans aged 50 years or older with positive COVID-19 testing prior to 2 May 2021.

Primary and secondary outcome measures

The primary outcome measure was hospitalisation. Secondary outcome measures were intensive care unit admission, mechanical ventilation and death. Potential associations between AMD and outcome measures occurring within 60 days of COVID-19 diagnosis were evaluated using multiple logistic regression analyses.

Results

Of the 171 325 patients in the study cohort, 7913 (5%) had AMD and 2152 (1%) had severe AMD, defined as advanced atrophic or exudative AMD disease coding. Multiple logistic regression adjusting for age, Charlson Comorbidity Index, sex, race, ethnicity and COVID-19 timing showed that an AMD diagnosis did not significantly increase the odds of hospitalisation (p=0.11). Using a Bonferroni-adjusted significance level of 0.006, AMD and severe AMD also were not significant predictors for the secondary outcomes, except for AMD being modestly protective for death (p=0.002).

Conclusions

After adjusting for other variables, neither AMD nor severe AMD was a risk factor for adverse COVID-19 outcomes in the VA healthcare system. These findings indicate that an AMD diagnosis alone should not alter recommended ophthalmic management based on COVID-19 adverse outcome risk.

Exploring disease-related and treatment-related issues and concerns experienced by adults with spondyloarthritis, inflammatory bowel disease and psoriasis to identify unmet needs: a qualitative clinical concept mapping study

Por: Stisen · Z. R. · Skougaard · M. · Christensen · K. R. · Ainsworth · M. A. · Hansen · R. L. · Thomsen · S. F. · Mogensen · M. · Dreyer · L. · Kristensen · L. E. · Jorgensen · T. S.
Objectives

Exploring patients’ perspectives for significant factors of relevance in living with a chronic disease is important to discover unmet needs and challenges. The primary objective of this study was to explore disease-related and treatment-related issues and concerns experienced by adults with spondyloarthropathies (SpA) and associated diseases. As a secondary objective, we wanted to explore whether these factors were generic or disease dependent.

Design

We used group concept mapping (GCM), a validated qualitative method, to identify disease-related and treatment-related issues and concerns. Participants generated statements in the GCM workshops and organised them into clusters to develop concepts. Furthermore, participants rated each statement for importance from 1: ‘not important at all’ to 5: ‘of great importance’.

Setting

Participants were recruited during routine care at the outpatient clinic at the hospitals in the period from May 2018 to July 2022.

Participants

Eligible participants were adults ≥18 years and diagnosed with axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), psoriasis (PsO) or inflammatory bowel disease —split into Crohn’s disease (CD) and ulcerative colitis (UC).

Results

52 patients participated in the 11 workshops divided into groups according to their diagnosis. They created a total of 1275 statements that generated 10 AxSpA concepts, 7 PsA concepts, 7 PsO concepts, 10 CD concepts and 11 UC concepts. The highest rated concepts within each disease group were: AxSpA, ‘lack of understanding/to be heard and seen by healthcare professionals’ (mean rating 4.0); PsA, ‘medication (effects and side effects)’ (mean rating 3.8); PsO, ‘social and psychological problems, the shame’ (mean rating 4.0); CD, ‘positive attitudes’ (mean rating 4.3) and UC; ‘take responsibility and control over your life’ (mean rating 4.0).

Conclusion

People with SpA and associated diseases largely agree on which concepts describe their disease-related and treatment-related issues and concerns with a few of them being more disease-specific.

Mapping the scientific literature on obstetrical and perinatal health among sexual and gender minoritised (SGM) childbearing people and their infants: a scoping review protocol

Por: Huang · A. K. · Soled · K. R. S. · Chen · L. · Schulte · A. R. · Hall · M.-F. E. · McLaughlin · C. · Srinivasan · S. · Jahan · A. B. · Mita · C. · Charlton · B. M.
Introduction

Sexual and gender minoritised (SGM) populations are disproportionately impacted by multilevel risk factors for obstetrical and perinatal outcomes, including structural (eg, stigma, discrimination, access to care) and individual risk factors (eg, partner violence, poor mental health, substance use). Emerging evidence shows SGM childbearing people have worse obstetrical outcomes and their infants have worse perinatal outcomes, when compared with their cisgender and heterosexual counterparts; this emerging evidence necessitates a comprehensive examination of existing literature on obstetrical and perinatal health among SGM people. The goal of this scoping review is to comprehensively map the extent, range and nature of scientific literature on obstetrical and perinatal physical health outcomes among SGM populations and their infants. We aim to summarise findings from existing literature, potentially informing clinical guidelines on perinatal care, as well as highlighting knowledge gaps and providing directions for future research.

Methods and analysis

We will follow the Joanna Briggs Institute (JBI) scoping review framework and report findings according to the PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. We will conduct a broad systematic search in Medline/PubMed, Embase, CINAHL and Web of Science Core Collection. Eligible studies will include peer-reviewed, empirical, English-language publications pertaining to obstetrical and perinatal physical health outcomes of SGM people or their infants. No temporal or geographical limitations will be applied to the search. Studies conducted in all settings will be considered. Records will be managed, screened and extracted by two independent reviewers. Study characteristics, key findings and research gaps will be presented in tables and summarised narratively.

Ethics and dissemination

Ethical approval is not required as primary data will not be collected. The findings of this scoping review will be disseminated through a peer-reviewed journal and conference presentations.

Protocol registration

Open Science Framework https://osf.io/6fg4a/.

Impact of a short online course on the accuracy of non-ophthalmic diabetic retinopathy graders in recognising glaucomatous optic nerves in Vietnam

Por: Olawoye · O. O. · Ha · T. H. · Pham · N. · Nguyen · L. · Cherwek · D. H. · Fowobaje · K. R. · Ross · C. · Coote · M. · Chan · V. F. · Kahook · M. · Peto · T. · Azuara-Blanco · A. · Congdon · N.
Purpose

To test an online training course for non-ophthalmic diabetic retinopathy (DR) graders for recognition of glaucomatous optic nerves in Vietnam.

Methods

This was an uncontrolled, experimental, before-and-after study in which 43 non-ophthalmic DR graders underwent baseline testing on a standard image set, completed a self-paced, online training course and were retested using the same photographs presented randomly. Twenty-nine local ophthalmologists completed the same test without the training course. DR graders then underwent additional one–to-one training by a glaucoma specialist and were retested. Test performance (% correct, compared with consensus grades from four fellowship-trained glaucoma experts), sensitivity, specificity, positive and negative predictive value, and area under the receiver operating (AUC) curve, were computed.

Results

Mean age of DR graders (32.6±5.5 years) did not differ from ophthalmologists (32.3±7.3 years, p=0.13). Online training required a mean of 297.9 (SD 144.6) minutes. Graders’ mean baseline score (33.3%±14.3%) improved significantly after training (55.8%±12.6%, p

Conclusion

Non-ophthalmic DR graders can be trained to recognise glaucoma using a short online course in this setting, with no additional benefit from more expensive one–to-one training. After 5-hour online training in recognising glaucomatous optic nerve head, scores of non-ophthalmic DR graders doubled, and did not differ from local ophthalmologists. Intensive one-to-one training did not further improve performance

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