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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.

Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0)

Por: Cho · J. · Noonan · S. H. · Fay · R. · Apovian · C. M. · McCarthy · A. C. · Blood · A. J. · Samal · L. · Fisher · N. · Orav · J. E. · Plutzky · J. · Block · J. P. · Bates · D. W. · Rozenblum · R. · Tucci · M. · McPartlin · M. · Gordon · W. J. · McManus · K. D. · Morrison-Deutsch · C. · Sci
Introduction

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

Methods and analysis

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25–29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

Ethics and dissemination

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

Trial registration number

NCT0555925.

Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol

Por: Tesfaye · W. · Krass · I. · Sud · K. · Johnson · D. W. · Van · C. · Versace · V. L. · McMorrow · R. · Fethney · J. · Mullan · J. · Tran · A. · Robson · B. · Vagholkar · S. · Kairaitis · L. · Gisev · N. · Fathima · M. · Tong · V. · Coric · N. · Castelino · R. L.
Introduction

Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.

Methods and analysis

This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.

Ethics and dissemination

The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).

Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial

Por: Schlechter · C. R. · Del Fiol · G. · Jones · D. R. · Orleans · B. · Gibson · B. · Nahum-Shani · I. · Maxfield · E. · Locke · A. · Cornia · R. · Bradshaw · R. · Wirth · J. · Jaggers · S. J. · Lam · C. Y. · Wetter · D. W.
Introduction

Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.

Methods and analysis

This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).

Ethics and dissemination

Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

clinicaltrials.gov; NCT05666323.

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol

Por: Tsze · D. S. · Kuppermann · N. · Casper · T. C. · Barney · B. J. · Richer · L. P. · Liberman · D. B. · Okada · P. J. · Morris · C. R. · Myers · S. R. · Soung · J. K. · Mistry · R. D. · Babcock · L. · Spencer · S. P. · Johnson · M. D. · Klein · E. J. · Quayle · K. S. · Steele · D. W. · Cr
Introduction

Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Methods and analysis

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics and dissemination

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

Implementing paediatric patient-reported outcome measures in outpatient asthma clinics: a feasibility assessment study

Por: Bele · S. · Paolucci · E. O. · Johnson · D. W. · Quan · H. · Santana · M.-J.
Objective

Implementation of patient-reported outcome measures (PROMs) is limited in paediatric routine clinical care. The KidsPRO programme has been codesigned to facilitate the implementation of PROMs in paediatric healthcare settings. Therefore, this study (1) describes the development of innovative KidsPRO programme and (2) reports on the feasibility of implementing PedsQL (Pediatric Quality of Life Inventory) PROM in asthma clinics using the KidsPRO programme.

Design

Feasibility assessment study.

Setting

Outpatient paediatric asthma clinics in the city of Calgary, Canada.

Participants

Five paediatric patients, four family caregivers and three healthcare providers were recruited to pilot the implementation of PedsQL PROM using KidsPRO. Then, a survey was used to assess its feasibility among these study participants.

Main outcome measures

Participants’ understanding of using PROMs, the adequacy of support provided to them, the utility of using PROMs as part of their appointment, and their satisfaction with using PROMs.

Analyses

The quantitative data generated through closed-ended questions was analysed and represented in the form of bar charts for each category of study participants (ie, patients, their family caregivers and healthcare providers). The qualitative data generated through the open-ended questions were content analysed and categorised into themes.

Results

The experience of using PROMs was overwhelmingly positive among patients and their family caregivers, results were mixed among healthcare providers. Qualitative data collected through open-ended questions also complemented the quantitative findings.

Conclusion

The evidence from this study reveals that the implementation of PROMs in routine paediatric clinical care asthma clinics in Alberta is seems to be feasible.

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