The femoral head contralateral to the collapsed femoral head requiring total hip arthroplasty (THA) often manifests in the precollapse stage of osteonecrosis of the femoral head (ONFH). It is not yet demonstrated how autologous concentrated bone marrow injection may prevent collapse of the femoral head concurrent with contralateral THA. The primary objective is to evaluate the efficacy of autologous concentrated bone marrow injection for the contralateral, non-collapsed, femoral head in patients with bilateral ONFH, with the ipsilateral collapsed femoral head undergoing THA.

This is a multicentre, prospective, non-randomised, historical-data controlled study. We will recruit patients with ONFH who are scheduled for THA and possess a non-collapsed contralateral femoral head. Autologous bone marrow will be collected using a point-of-care device. After concentration, the bone marrow will be injected into the non-collapsed femoral head following the completion of THA in the contralateral hip. The primary outcome is the percentage of femoral head collapse evaluated by an independent data monitoring committee using plain X-rays in two directions 2 years after autologous concentrated bone marrow injection. Postinjection safety, adverse events, pain and hip function will also be assessed. The patients will be evaluated preoperatively, and at 6 months, 1 year and 2 years postoperatively.

This protocol has been approved by the Certified Committee for Regenerative Medicine of Tokyo Medical and Dental University and Japan’s Ministry of Healthy, Labour and Welfare and will be performed as a class III regenerative medicine protocol, in accordance with Japan’s Act on the Safety of Regenerative Medicine. The results of this study will be submitted to a peer-review journal for publication. The results of this study are expected to provide evidence to support the inclusion of autologous concentrated bone marrow injections in the non-collapsed femoral head in Japan’s national insurance coverage.

jRCTc032200229.

Opioid overdoses in the USA have increased to unprecedented levels. Administration of the opioid antagonist naloxone can prevent overdoses.

This study was conducted to reveal the pharmacoepidemiologic patterns in naloxone prescribing to Medicaid patients from 2018 to 2021 as well as Medicare in 2019.

Observational pharmacoepidemiologic study

US Medicare and Medicaid naloxone claims

The Medicaid State Drug Utilisation Data File was utilised to extract information on the number of prescriptions and the amount prescribed of naloxone at a national and state level. The Medicare Provider Utilisation and Payment was also utilised to analyse prescription data from 2019.

States with naloxone prescription rates that were outliers of quartile analysis were noted.

The number of generic naloxone prescriptions per 100 000 Medicaid enrollees decreased by 5.3%, whereas brand naloxone prescriptions increased by 245.1% from 2018 to 2021. There was a 33.1-fold difference in prescriptions between the highest (New Mexico=1809.5) and lowest (South Dakota=54.6) states in 2019. Medicare saw a 30.4-fold difference in prescriptions between the highest (New Mexico) and lowest states (also South Dakota) after correcting per 100 000 enrollees.

This pronounced increase in the number of naloxone prescriptions to Medicaid patients from 2018 to 2021 indicates a national response to this widespread public health emergency. Further research into the origins of the pronounced state-level disparities is warranted.

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Pessary therapy and surgery.

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

NTR4883.

The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder.

Multicentre, randomised feasibility trial, with embedded qualitative study.

Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services.

Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder.

Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later.

(1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months.

Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%.

This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment.

ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

Improving sustainable transportation options will help cities tackle growing challenges related to population health, congestion, climate change and inequity. Interventions supporting active transportation face many practical and political hurdles. Implementation science aims to understand how interventions or policies arise, how they can be translated to new contexts or scales and who benefits. Sustainable transportation interventions are complex, and existing implementation science frameworks may not be suitable. To apply and adapt implementation science for healthy cities, we have launched our mixed-methods research programme, CapaCITY/É. We aim to understand how, why and for whom sustainable transportation interventions are successful and when they are not.

Across nine Canadian municipalities and the State of Victoria (Australia), our research will focus on two types of sustainable transportation interventions: all ages and abilities bicycle networks and motor vehicle speed management interventions. We will (1) document the implementation process and outcomes of both types of sustainable transportation interventions; (2) examine equity, health and mobility impacts of these interventions; (3) advance implementation science by developing a novel sustainable transportation implementation science framework and (4) develop tools for scaling up and scaling out sustainable transportation interventions. Training activities will develop interdisciplinary scholars and practitioners able to work at the nexus of academia and sustainable cities.

This study received approval from the Simon Fraser University Office of Ethics Research (H22-03469). A Knowledge Mobilization Hub will coordinate dissemination of findings via a website; presentations to academic, community organisations and practitioner audiences; and through peer-reviewed articles.

We conducted an updated systematic review and meta-analysis to investigate the effect of colchicine treatment on clinical outcomes in patients with COVID-19.

Systematic review and meta-analysis.

We searched PubMed, Embase, the Cochrane Library, medRxiv and ClinicalTrials.gov from inception to January 2023.

All randomised controlled trials (RCTs) that investigated the efficacy of colchicine treatment in patients with COVID-19 as compared with placebo or standard of care were included. There were no language restrictions. Studies that used colchicine prophylactically were excluded.

We extracted all information relating to the study characteristics, such as author names, location, study population, details of intervention and comparator groups, and our outcomes of interest. We conducted our meta-analysis by using RevMan V.5.4 with risk ratio (RR) and mean difference as the effect measures.

We included 23 RCTs (28 249 participants) in this systematic review. Colchicine did not decrease the risk of mortality (RR 0.99; 95% CI 0.93 to 1.05; I²=0%; 20 RCTs, 25 824 participants), with the results being consistent among both hospitalised and non-hospitalised patients. There were no significant differences between the colchicine and control groups in other relevant clinical outcomes, including the incidence of mechanical ventilation (RR 0.75; 95% CI 0.48 to 1.18; p=0.22; I²=40%; 8 RCTs, 13 262 participants), intensive care unit admission (RR 0.77; 95% CI 0.49 to 1.22; p=0.27; I²=0%; 6 RCTs, 961 participants) and hospital admission (RR 0.74; 95% CI 0.48 to 1.16; p=0.19; I²=70%; 3 RCTs, 8572 participants).

The results of this meta-analysis do not support the use of colchicine as a treatment for reducing the risk of mortality or improving other relevant clinical outcomes in patients with COVID-19. However, RCTs investigating early treatment with colchicine (within 5 days of symptom onset or in patients with early-stage disease) are needed to fully elucidate the potential benefits of colchicine in this patient population.

CRD42022369850.

Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.

We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.

This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.

Globally, cardiovascular disease (CVD) remains the leading cause of death, warranting effective management and prevention measures. Risk prediction tools are indispensable for directing primary and secondary prevention strategies for CVD and are critical for estimating CVD risk. Machine learning (ML) methodologies have experienced significant advancements across numerous practical domains in recent years. Several ML and statistical models predicting CVD time-to-event outcomes have been developed. However, it is not known as to which of the two model types—ML and statistical models—have higher discrimination and calibration in this regard. Hence, this planned work aims to systematically review studies that compare ML with statistical methods in terms of their predictive abilities in the case of time-to-event data with censoring.

Original research articles published as prognostic prediction studies, which involved the development and/or validation of a prognostic model, within a peer-reviewed journal, using cohort or experimental design with at least a 12-month follow-up period will be systematically reviewed. The review process will adhere to the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies checklist.

Ethical approval is not required for this review, as it will exclusively use data from published studies. The findings of this study will be published in an open-access journal and disseminated at scientific conferences.

CRD42023484178.

An important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution.

A cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms.

The study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients.

NCT04624737

To analyse monthly changes in public access defibrillation (PAD) incidence and outcomes of out-of-hospital cardiac arrest (OHCA) during the 2020–2021 COVID-19 pandemic compared with those during the 2016–2019 prepandemic period with consideration of pandemic-related movement restriction.

Retrospective cohort study.

An extended database was created by combining and reconciling the nationwide Utstein-style OHCA and the emergency medical service (EMS) transportation databases in Japan.

We analysed 226 182 EMS-witnessed, non-newborn and out-of-home OHCA cases in Japan.

The primary outcomes were the PAD incidence and neurologically favourable 1-month survival rate. The secondary outcomes were bystander cardiopulmonary resuscitation (CPR) provision and dispatcher-assisted CPR attempts.

The proportion of out-of-home OHCA cases slightly decreased during the pandemic (from 33.7% to 31.9%). Although the pandemic was associated with a decreased PAD incidence, 2-year trend analyses by an interaction test showed that the PAD incidence was lower during the first nationwide declaration of a state of emergency (p

Prolonged and repeated movement restrictions during the COVID-19 pandemic worsened the OHCA outcomes concurrently with disturbed BLS actions, including the reduced PAD incidence in out-of-home settings. Maintaining BLS training, re-arranging automated external defibrillator placement and establishing a local alert system for recruiting well-trained citizens to the scene are essential.

Inadequate counselling of pregnant women regarding pregnancy danger signs contributes to a delay in deciding to seek care, which causes up to 77% of all maternal deaths in developing countries. However, its spatial variation and region-specific predictors have not been studied in Ethiopia. Hence, the current study aimed to model its predictors using geographically weighted regression analysis.

The 2019 Ethiopian Mini Demographic and Health Survey data were used. A total weighted sample of 2922 women from 283 clusters was included in the final analysis. The analysis was performed using ArcGIS Pro, STATA V.14.2 and SaTScan V.10.1 software. The spatial variation of inadequate counselling was examined using hotspot analysis. Ordinary least squares regression was used to identify factors for geographical variations. Geographically weighted regression was used to explore the spatial heterogeneity of selected variables to predict inadequate counselling.

Significant hotspots of inadequate counselling regarding pregnancy danger signs were found in Gambella region, the border between Amhara and Afar regions, Somali region and parts of Oromia region. Antenatal care provided by health extension workers, late first antenatal care initiation and antenatal care follow-up at health centres were spatially varying predictors. The geographically weighted regression model explained about 66% of the variation in the model.

Inadequate counselling service regarding pregnancy danger signs in Ethiopia varies across regions and there exists within country inequality in the service provision and utilisation. Prioritisation and extra efforts should be made by concerned actors for those underprivileged areas and communities (as shown in the maps), and health extension workers, as they are found in the study.

Unintended teenage pregnancies have become a global public health challenge, particularly in sub-Saharan Africa. There is a notably high prevalence of unintended pregnancies among unmarried teenagers in Uganda. This study will develop an intervention programme using mobile money shops (vendors) as a platform to deliver sexual and reproductive health and rights (SRHR) services to teenagers and assess its effectiveness and scalability in Uganda.

This hybrid study comprises two integral components: an intervention study to assess the effectiveness of vendor-mediated intervention and implementation research to evaluate the implementation process. 30 vendors will be recruited for both intervention and control arms in 2 municipalities in Eastern Uganda, which have a high unintended pregnancy prevalence rate among unmarried teens aged 15–19 years. A preintervention and postintervention repeated survey involving 600 participants for each arm will be conducted over 4 months. The primary outcome is the rate of condom users among teenage vendor users. The secondary outcomes include the rate of preference for receiving SRHR services at vendors and knowledge regarding SRHR. A difference-in-differences analysis will be used to determine the effectiveness of the intervention. The Bowen model will be employed to evaluate the implementation design.

Ethical approval was obtained from the Ethics Review Committee of Uganda Christen University and JICA Ogata Sadako Research Institute for Peace and Development in Japan. The findings will be widely disseminated. This study was registered with the University Hospital Medical Information Network in Japan (UMIN000053332) on 12 January 2024.

UMIN000053332.

Mental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL. This systematic review will examine and compare the measurement properties of the MHLS in different languages, enabling academics, clinicians and policymakers to make informed judgements regarding its use in assessments.

The review will adhere to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of patient-reported outcome measures and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and will be presented following the Preferred Reporting Items for Systematic reviews and Meta-Analysis 2020 checklist. The review will be conducted in four stages, including an initial search confined to PubMed, a search of electronic scientific databases PsycINFO, CINAHL, Scopus, MEDLINE, Embase (Elsevier), PubMed (NLM) and ERIC, an examination of the reference lists of all papers to locate relevant publications and finally contacting the MHLS original author to identify validation studies that the searches will not retrieve. These phases will assist us in locating studies that evaluate the measurement properties of MHLS across various populations, demographics and contexts. The search will focus on articles published in English between May 2015 and December 2023. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, and a comprehensive qualitative and quantitative data synthesis will be performed.

Ethics approval is not required. The publication will be in peer-reviewed journals and presented at national and international conferences.

CRD42023430924.

Deep brain stimulation (DBS) can be used to treat several neurological and psychiatric conditions such as Parkinson’s disease, epilepsy and obsessive-compulsive disorder; however, limited work has been done to assess the disparities in DBS access and implementation. The goal of this scoping review is to identify sources of disparity in the clinical provision of DBS.

A scoping review will be conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-extension for Scoping Reviews methodology. Relevant studies will be identified from databases including MEDLINE/PubMed, EMBASE and Web of Science, as well as reference lists from retained articles. Initial search dates were in January 2023, with the study still ongoing. An initial screening of the titles and abstracts of potentially eligible studies will be completed, with relevant studies collected for full-text review. The principal investigators and coauthors will then independently review all full-text articles meeting the inclusion criteria. Data will be extracted and collected in table format. Finally, results will be synthesised in a table and narrative report.

No institutional board review or approval is necessary for the proposed scoping review. The findings will be submitted for publication to relevant peer-reviewed journals and conferences.

This protocol has been registered prospectively on the Open Science Framework (https://osf.io/cxvhu).

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

We conducted a secondary data analysis with a quasi-experimental design.

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

To examine the relative importance of the drivers of mental health care-seeking intention and how these, along with intention itself, are geographically distributed across integrated care systems (ICS) and health boards (HBs) in the UK. Also, to examine the degree of acceptance of virtual modes of care.

Community-based cross-sectional survey.

A national online survey of 17 309 adults between August and September 2021 recruited via a research technology company, Lucid. Sample size quotas were set to ensure coverage across the UK and match population distributions for gender, age and ethnicity. After exclusions, 16 835 participants remained (54% female, 89% white).

Care-seeking intention, using a continuous measure of likelihood and a categorical measure of estimated time to seek professional help for a future mental health difficulty.

20.5% (95% CI 19.8% to 21.2%) reported that they would significantly delay or never seek mental healthcare, ranging from 8.3% to 25.7% across ICS/HBs. Multilevel regression analysis showed mental health knowledge was the most predictive of care-seeking intention, followed by attitudes towards others with mental illness and a combination of stigma, negative attitudes to treatment and instrumental barriers to accessing care. The model explained 17% of the variance. There was substantial geographical variation in prevalence of preclinical symptoms of depression and anxiety, attitudes to mental health, and barriers to care, leading to complex ICS/HB profiles. Remote and self-guided therapies did not pose as a major barrier to care with more than half of respondents likely or very likely to use them.

Our locally relevant and actionable findings suggest possible interventions that may improve care-seeking intention and indicate which of these interventions need to be geographically tailored to have maximal effect.

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.

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.

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.

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

NCT04766866.

Sexual and gender minority (SGM) populations in sub-Saharan Africa (SSA) are disproportionately impacted by HIV and often face multiple HIV-related stigmas. Addressing these stigmas could reduce SGM HIV vulnerability but little is known about how the stigmas operate and intersect. Intersectional stigma offers a lens for understanding the experiences of stigmatised populations and refers to the synergistic negative health effects of various systems of oppression on individuals with multiple stigmatised identities, behaviours or conditions. This review aims to (1) assess how often and in what ways an intersectional lens is applied in HIV-related stigma research on SGM populations in SSA and (2) understand how intersectional stigma impacts HIV risk in these populations.

Scoping review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews.

Public health and regional databases were searched in 2020 and 2022.

Articles in French and English on HIV-related stigma and HIV outcomes among men who have sex with men, women who have sex with women and/or transgender individuals in SSA.

Articles were screened and extracted twice and categorised by use of an intersectional approach. Study designs and stigma types were described quantitatively and findings on intersectional stigma were thematically analysed.

Of 173 articles on HIV-related stigma among SGM in SSA included in this review, 21 articles (12%) applied an intersectional lens. The most common intersectional stigmas investigated were HIV and same-sex attraction/behaviour stigma and HIV, same-sex attraction/behaviour and gender non-conformity stigma. Intersectional stigma drivers, facilitators and manifestations were identified across individual, interpersonal, institutional and societal socioecological levels. Intersectional stigma impacts HIV vulnerability by reducing HIV prevention and treatment service uptake, worsening mental health and increasing exposure to HIV risk factors.

Intersectional approaches are gaining traction in stigma research among SGM in SSA. Future research should prioritise quantitative and mixed methods investigations, diverse populations and intervention evaluation.