Remote self-report and speech-in-noise measures predict clinical audiometric thresholds.

OBJECTIVE: Developments in smartphone technology and the COVID-19 pandemic have highlighted the feasibility and need for remote, but reliable hearing tests. Previous studies used remote testing but did not directly compare results in the same listeners with standard lab or clinic testing. This study investigated validity and reliability of remote, self-administered digits-in-noise (remote-DIN) compared with lab-based, supervised (lab-DIN) testing. Predictive validity was further examined in relation to a commonly used self-report, Speech, Spatial, and Qualities of Hearing (SSQ-12), and lab-based, pure tone audiometry. DESIGN: DIN speech reception thresholds (SRTs) of adults (18-64 y/o) with normal hearing (NH, N = 16) and hearing loss (HL, N = 18), were measured using English-language digits (0-9), binaurally presented as triplets in one of four speech-shaped noise maskers (broadband, low-pass filtered at 2, 4, 8 kHz) and two phases (diotic, antiphasic). RESULTS: High, significant intraclass correlation coefficients indicated strong internal consistency of remote-DIN SRTs, which also correlated significantly with lab-DIN SRTs. There was no significant mean difference between remote- and lab-DIN on any tests. NH listeners had significantly higher SSQ scores and remote- and lab-DIN SRTs than listeners with HL. All versions of remote-DIN SRTs correlated significantly with pure-tone-average (PTA), with the 2-kHz filtered test being the best predictor, explaining 50% of the variance in PTA. SSQ total score also significantly and independently predicted PTA (17% of variance) and all test versions of the remote-DIN, except the antiphasic BB test. CONCLUSIONS: This study underscores the effectiveness of remote DIN test and SSQ-12 in assessing auditory function. These findings suggest the potential for wider access to reliable hearing assessment, particularly in remote or underserved communities.

Comparing the Efficacy and Efficiency of Human and Generative AI: Qualitative Thematic Analyses.

BACKGROUND: Qualitative methods are incredibly beneficial to the dissemination and implementation of new digital health interventions; however, these methods can be time intensive and slow down dissemination when timely knowledge from the data sources is needed in ever-changing health systems. Recent advancements in generative artificial intelligence (GenAI) and their underlying large language models (LLMs) may provide a promising opportunity to expedite the qualitative analysis of textual data, but their efficacy and reliability remain unknown. OBJECTIVE: The primary objectives of our study were to evaluate the consistency in themes, reliability of coding, and time needed for inductive and deductive thematic analyses between GenAI (ie, ChatGPT and Bard) and human coders. METHODS: The qualitative data for this study consisted of 40 brief SMS text message reminder prompts used in a digital health intervention for promoting antiretroviral medication adherence among people with HIV who use methamphetamine. Inductive and deductive thematic analyses of these SMS text messages were conducted by 2 independent teams of human coders. An independent human analyst conducted analyses following both approaches using ChatGPT and Bard. The consistency in themes (or the extent to which the themes were the same) and reliability (or agreement in coding of themes) between methods were compared. RESULTS: The themes generated by GenAI (both ChatGPT and Bard) were consistent with 71% (5/7) of the themes identified by human analysts following inductive thematic analysis. The consistency in themes was lower between humans and GenAI following a deductive thematic analysis procedure (ChatGPT: 6/12, 50%; Bard: 7/12, 58%). The percentage agreement (or intercoder reliability) for these congruent themes between human coders and GenAI ranged from fair to moderate (ChatGPT, inductive: 31/66, 47%; ChatGPT, deductive: 22/59, 37%; Bard, inductive: 20/54, 37%; Bard, deductive: 21/58, 36%). In general, ChatGPT and Bard performed similarly to each other across both types of qualitative analyses in terms of consistency of themes (inductive: 6/6, 100%; deductive: 5/6, 83%) and reliability of coding (inductive: 23/62, 37%; deductive: 22/47, 47%). On average, GenAI required significantly less overall time than human coders when conducting qualitative analysis (20, SD 3.5 min vs 567, SD 106.5 min). CONCLUSIONS: The promising consistency in the themes generated by human coders and GenAI suggests that these technologies hold promise in reducing the resource intensiveness of qualitative thematic analysis; however, the relatively lower reliability in coding between them suggests that hybrid approaches are necessary. Human coders appeared to be better than GenAI at identifying nuanced and interpretative themes. Future studies should consider how these powerful technologies can be best used in collaboration with human coders to improve the efficiency of qualitative research in hybrid approaches while also mitigating potential ethical risks that they may pose.

Multidisciplinary assessment and interventions for childhood auditory processing disorder (APD) and listening difficulties (LiD).

Purpose: Auditory processing disorder (APD) has been studied in both research and clinic settings, but the relation between the two has not been addressed. In a longitudinal research study (SICLiD), we found that children with clinically normal audiometry who had caregiver-reported listening difficulties (LiD), with or without clinically assessed APD, performed poorly on both listening and cognitive tests. Specific questions asked here were, for the children with LiD, what other neurodevelopmental clinical conditions were identified, what interventions were used by different clinical providers, and how clinical practice was predicted by research results. Methods: Study setting was a large, research-led, tertiary pediatric hospital. Electronic medical records of 74 children aged 6-13 years, recruited into SICLiD and assigned to an LiD group based on a validated and reliable caregiver report (ECLiPS), were independently reviewed. Focus was on clinical assessments and interventions following appointments provided in the Hospital Divisions of Audiology, Occupational Therapy, Psychology (Developmental and Behavioral Pediatrics), and Speech-Language Pathology (SLP), prior to participation in SICLiD. Descriptive statistics on clinical encounters, identified conditions, and interventions were compared with quantitative, standardized performance on SICLiD assessments of listening and cognitive function. SICLiD z-scores were compared for participants with and without each clinical condition using univariate and logistic prediction analyses. Results: Most (86%) of the children with LiD had been evaluated by at least one clinical service. Overall, 24 assessment categories related to LiD, including APD, were identified. Most common conditions were attention (32%), language (28%), hearing (18%), anxiety (16%), and autism spectrum (6%) disorders. Performance on SICLiD measures varied significantly between providers, conditions, and interventions. Significant relationships between SICLiD and clinical conditions were mostly caregiver-reported items from the ECLiPS or the Children's Communication Checklist (CCC-2). Other significant correlations were scarce, but included the SCAN composite score, which predicted clinical language and attention, but not other auditory abilities or APD. SICLiD data combined with caregiver reports provided reliable predictions of all clinical conditions except APD. Conclusions: The variety of disciplines, assessments, conditions and interventions revealed here supports previous studies showing that LiD and APD are multifaceted problems of neurodevelopment. Comparisons between clinical- and research-based assessments suggest a diagnostic path that prioritizes caregiver reports and selected psychometric tests for screening and diagnostic purposes.

The surgical outpatient clinic and the environment.

Rising global temperatures will have a radical impact on the environment where global warming is associated with weather extremes such as thunderstorms and droughts which can affect the regional ecosystems. The healthcare sector is a major emitter of greenhouse gasses. Within healthcare, the outpatient clinic is responsible for a considerable sum of emissions. These can be organized under scopes 1, 2 and 3 as described in the Greenhouse Gas Protocol where scope 1 accounts for direct emissions from healthcare facilities, scope 2 is emissions from purchased electricity and scope 3 is indirect emissions including procurement and waste. Emissions and mitigation strategies from the surgical outpatient clinic are outlined under each scope of the Greenhouse Gas Protocol. These include using insulation materials, renovating or building new facilities, incorporating renewable energy sources and utilizing more efficient appliances. Telehealth and virtual clinics have been shown to be an effective method of delivering care while avoiding the combustion of fossil fuels to facilitate patient transport. In addition, virtual set-ups are cost effective and have not been proven to compromise patient safety when implemented correctly.

Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids.

Importance: With rising interest in over-the-counter (OTC) hearing aids as an alternative to traditional audiologist-fit devices, understanding their long-term efficacy is crucial. However, given the novelty of the US Food and Drug Administration category of OTC hearing aids, minimal evidence currently supports their long-term efficacy. Objective: To compare the long-term self-reported outcomes at 8 months of self-fit OTC hearing aids to the same hearing aids fit by audiologists. Design, Setting, and Participants: Building on a previous randomized clinical trial, this follow-up comparative effectiveness research study reassessed a number of the original participants that were not lost to follow-up. Participants were initially divided into those with self-fit OTC hearing aids and those with audiologist-fit devices. Approximately 8 months after fitting, participants completed self-reported questionnaires. Missing data were addressed through multiple imputation. The original noninferiority trial was conducted at the University of Pretoria in South Africa from April 2022 to August 2022. The current analysis took place between July 7, 2023, to November 20, 2023. Interventions: In the original trial, participants in the self-fit device group received a pair of OTC hearing aids and independently fit them with remote support as needed. The audiologist-fit device group received the same hearing aids fit by a certified audiologist using best practices. Main Outcomes and Measures: The main outcomes were self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA). Results: Of 64 participants in the trial, 44 participants were included in the extension study (21 [47.7%] in the audiologist-fit group; 23 [52.3%] in the self-fit group). The mean (SD) age of these participants was 63.0 (13.2) years, and 21 (47.7%) were male. At the long-term follow-up, self-fit and audiologist-fit groups showed no significant differences in the APHAB global score (mean difference, 0.02 [95% CI, -7.1 to 7.1]; Cohen d, 0.01 [95% CI, -0.5 to 0.5]) or the IOI-HA total score (mean difference, 1.5 [95% CI, -1.4 to 4.4]; Cohen d, 0.3 [95% CI, -0.2 to 0.8]). From 6 weeks to 8 months, no clinically meaningful group-time interaction was found between groups for the APHAB global score (Cohen d, 0.1 [95% CI, -0.2 to 0.3]), but a significant interaction for the IOI-HA total score was found (Cohen d, -0.6 [95% CI, -0.8 to -0.3]), with the self-fit group generally performing better. Conclusion: This comparative effectiveness research study demonstrated that self-fit OTC hearing aids can offer comparable long-term benefits to audiologist-fit hearing aids for individuals with mild to moderate hearing loss.

Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial.

Importance: Fewer than 20% of US adults with hearing loss use hearing aids due to barriers like high cost. Over-the-counter (OTC) hearing aids offer a potential solution, incorporating self-fitting strategies via smartphone apps. Self-fitting strategies have been validated for Food and Drug Administration (FDA)-approved OTC hearing aids compared with prescription-based approaches. However, no direct comparative analysis exists between in situ audiometry and self-adjustment strategies using self-fitting OTC (OTC-SF) hearing aids. Objective: To compare self-adjustment and in situ audiometry self-fitting strategies in OTC-SF hearing aids for adults with mild to moderate hearing difficulties. Design Settings and Participants: A crossover, within-participant pseudorandomized clinical trial was conducted between July and November 2023. Twenty-eight participants were pseudo-randomly assigned to 1 of the 2 self-fitting strategies, and they experienced both interventions for 4 consecutive weeks. Interventions: The self-adjustment group manually adjusted settings, including overall gain and spectral tilt, using Lexie B2 hearing aids, while the in situ audiometry group used Lexie B2 Plus hearing aids (Lexie Hearing by hearX Group), with an automated fitting based on in situ tests conducted through the app. Main Outcomes and Measures: The primary outcome was Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary outcomes were International Outcome Inventory for Hearing Aids (IOI-HA), speech-in-noise tests (DIN and QuickSIN), and real-ear measurements (REMs). Measures were completed at baseline and after the 4-week field trial using each strategy. Results: Twenty-eight participants (mean [SD] age, 60.2 [12.0] years) were included; 14 men and 14 women. Self-adjustment and in situ audiometry strategies produced no clinically meaningful differences across various outcome measures, including overall APHAB benefit (Cohen d = 0.2; 95% CI, -0.2 to 0.6) and overall IOI-HA satisfaction (Rosenthal r = 0.0; 95% CI, -0.3 to 0.2). Self-adjustment users reported higher satisfaction (Rosenthal r = -0.4; 95% CI, -0.6 to -0.1) and longer daily use (Rosenthal r = -0.3; 95% CI, -0.5 to 0.0) compared with those using in situ audiometry. No clinically meaningful differences were observed in speech-in-noise benefit and real-ear measurements. Conclusion and Relevance: In this clinical trial of OTC-SF hearing aids, self-adjustment and in situ audiometry strategies resulted in similar outcomes. However, self-adjustment may produce higher satisfaction and longer daily use, highlighting the potential advantages of active user involvement in the fitting process. Further investigation is needed for long-term outcomes. Trial registration: ClinicalTrials.gov Identifier: NCT05782153.

Prevalence of Oral Human Papillomavirus Infection Among Urban Gay, Bisexual, and Other Men Who Have Sex With Men in Canada, 2017-2019.

BACKGROUND: Oral human papillomavirus (HPV) infections are a leading cause of oropharyngeal cancers. In 2015 and 2016, HPV vaccines became publicly funded for gay, bisexual, and other men who have sex with men (GBM) under 27 years of age in most Canadian provinces. METHODS: Between 2017 and 2019, sexually-active GBM in Montreal, Toronto, and Vancouver were recruited through respondent-driven sampling. Participants aged 16 to 30 years were invited to self-collect oral rinse specimens for HPV testing. We estimated HPV prevalence in the oral tract overall and compared these by vaccination status. RESULTS: Among the 838 GBM with a valid oral specimen, 36.9% reported receiving ≥1 dose of HPV vaccine. Overall, oral HPV prevalence was 2.6% (95% confidence interval, CI: 1.5, 3.7%) for at least one HPV type and 1.2% (95% CI: 0.5, 1.9%) for any high-risk type. We detected quadrivalent (HPV 6/11/16/18) vaccine-preventable types in 0.3% (95% CI: 0.0, 1.0%) of vaccinated individuals and 1.1% (95% CI: 0.1, 2.0%) in unvaccinated individuals. CONCLUSIONS: Oral HPV prevalence was low in a population of young urban GBM in Canada of whom 37% were vaccinated. Findings serve as a benchmark for monitoring of vaccination impacts on oral HPV infection within this priority population.

Second Primary Lung Cancer - An Emerging Issue in Lung Cancer Survivors.

As a result of an increased focus on early detection including lung cancer screening, combined with more curative treatment options, the 5-year survival rates for lung cancer are improving. Welcome though this is, it brings new, hitherto unseen challenges. As more patients are cured and survive longer, they are at risk of developing second primary cancers, particularly lung cancer. In this review, we examine the challenges that surveillance, diagnosis, and management of second primary lung cancer (SPLC) bring and how these can be addressed. Recent data from prospective follow-up studies suggests that the incidence of SPLC may be higher than previously appreciated, partly due to an increase in multi-focal adenocarcinoma spectrum disease. Over 5 years, up to 1 in 6 long-term lung cancer survivors may develop a SPLC. Although not routinely used in clinical practice at present, genomic approaches for differentiating SPLC from intrapulmonary metastases of the first primary are emerging, and we highlight how this could be used to help differentiate lesions. An accurate distinction between SPLC and the recurrence of the first primary is of paramount importance due to the very different management strategies that may be required. Wrongly classifying an SPLC as a recurrence of the first primary may have significant consequences for patient management and overall survival. Updated approaches to the classification of SPLC combining clinical history, histopathological assessment, and genomic profiling are needed. Finally, we review the potential role of early detection biomarkers in the identification of SPLC, focusing in particular on blood-based biomarkers that are being examined in a multi-center prospective study recruiting lung cancer survivors.

Postural Stability as a Measure of Fall Risk in Older People with and without HIV.

As the number of older people with HIV (PWH) grows, accidental falls and their associated negative health outcomes are of increasing concern. Fall risk can be measured using novel screening tools such as evaluating postural stability using force plate technology. The aims of this study were to test this technology to assess fall risk among older PWH. In a cross-sectional, observational study of people without HIV (PWoH) with a range of fall risk, participants underwent balance assessment using the validated BTrackS balance plate. Postural stability was compared by HIV serostatus. Multivariable linear regressions were used to examine the relationship between postural stability and validated measures of fall risk balance and frailty status. Among 34 PWH and 30 PWoH, all ≥50 years, postural stability was worse among PWH (35.4 cm vs. 28.3 cm, p = .07). In multivariable models, worse postural stability was associated with reporting a fall in the past 6 months (ß = 0.32, p = .004), worse fall efficacy (ß = 0.45, p < .001), and being frail or prefrail (ß = 0.26, p = .027). In multivariable models stratified by HIV serostatus, worse postural stability was significantly associated with worse fall efficacy (ß = 0.53, p < .01) and lower balance confidence (ß = -0.33, p =. 04) among PWH but not PWoH. Among older PWH and PWoH, worse postural stability was associated with validated measures of fall risk, including history of falls and poorer fall efficacy. Assessment of postural sway is a promising objective screening test for fall risk among older PWH.

A longitudinal study investigating the effects of noise exposure on behavioural, electrophysiological and self-report measures of hearing in musicians with normal audiometric thresholds.

Musicians are at risk of hearing loss and tinnitus due to regular exposure to high levels of noise. This level of risk may have been underestimated previously since damage to the auditory system, such as cochlear synaptopathy, may not be easily detectable using standard clinical measures. Most previous research investigating hearing loss in musicians has involved cross-sectional study designs that may capture only a snapshot of hearing health in relation to noise exposure. The aim of this study was to investigate the effects of cumulative noise exposure on behavioural, electrophysiological, and self-report indices of hearing damage in early-career musicians and non-musicians with normal hearing over a 2-year period. Participants completed an annual test battery consisting of pure tone audiometry, extended high-frequency hearing thresholds, distortion product otoacoustic emissions (DPOAEs), speech perception in noise, auditory brainstem responses, and self-report measures of tinnitus, hyperacusis, and hearing in background noise. Participants also completed the Noise Exposure Structured Interview to estimate cumulative noise exposure across the study period. Linear mixed models assessed changes over time. The longitudinal analysis comprised 64 early-career musicians (female n = 34; age range at T0 = 18-26 years) and 30 non-musicians (female n = 20; age range at T0 = 18-27 years). There were few longitudinal changes as a result of musicianship. Small improvements over time in some measures may be attributable to a practice/test-retest effect. Some measures (e.g., DPOAE indices of outer hair cell function) were associated with noise exposure at each time point, but did not show a significant change over time. A small proportion of participants reported a worsening of their tinnitus symptoms, which participants attributed to noise exposure, or not using hearing protection. Future longitudinal studies should attempt to capture the effects of noise exposure over a longer period, taken at several time points, for a precise measure of how hearing changes over time. Hearing conservation programmes for "at risk" individuals should closely monitor DPOAEs to detect early signs of noise-induced hearing loss when audiometric thresholds are clinically normal.

Gene expression and chromatin conformation of microglia in virally suppressed people with HIV.

The presence of HIV in sequestered reservoirs is a central impediment to a functional cure, allowing HIV to persist despite life-long antiretroviral therapy (ART), and driving a variety of comorbid conditions. Our understanding of the latent HIV reservoir in the central nervous system is incomplete, because of difficulties in accessing human central nervous system tissues. Microglia contribute to HIV reservoirs, but the molecular phenotype of HIV-infected microglia is poorly understood. We leveraged the unique "Last Gift" rapid autopsy program, in which people with HIV are closely followed until days or even hours before death. Microglial populations were heterogeneous regarding their gene expression profiles but showed similar chromatin accessibility landscapes. Despite ART, we detected occasional microglia containing cell-associated HIV RNA and HIV DNA integrated into open regions of the host's genome (∼0.005%). Microglia with detectable HIV RNA showed an inflammatory phenotype. These results demonstrate a distinct myeloid cell reservoir in the brains of people with HIV despite suppressive ART. Strategies for curing HIV and neurocognitive impairment will need to consider the myeloid compartment to be successful.

Waste management in the operating theatre.

INTRODUCTION: Poor clinical waste management and its effect on the environment is an increasingly recognised concern for global healthcare systems. Approximately two thirds of waste produced in healthcare is from the operating theatre. In the Republic of Ireland, an estimated 580,977 tonnes of hazardous waste was produced in 2019. The cost of incineration of this hazardous waste is approximately €2,125 per tonne and €935 per tonne for sterilisation. Pollution from incineration is substantial and harmful. METHODS: A literature review was performed on the topic of hospital waste management, specifically looking at the Republic of Ireland. A comparison could then be drawn between Ireland, Europe and the United States of America. Observation of our current operating theatre environment and practices were carried out. DISCUSSION: An increased focus towards sustainability and reusable equipment means that there is potentially a decreased amount of waste for disposal, but an increase in the process of sterilisation. Approximately 66% of healthcare related waste is inappropriately contaminated, meaning that significant savings are possible if correct segregation and recycling were to occur. An increase in the amount of bins, identification labels above bins and education of staff results in an increased likelihood of successful segregation of waste. Clear and concise hospital guidelines of what is considered hazardous versus non-hazardous waste will decrease the amount of inappropriately disposed items.

Biopsychosocial phenotypes in people with HIV in the CHARTER cohort.

Neuropsychiatric complications such as neurocognitive impairment and depression are common in people with HIV despite viral suppression on antiretroviral therapy, but these conditions are heterogeneous in their clinical presentations and associated disability. Identifying novel biopsychosocial phenotypes that account for neurocognitive performance and depressive and functional symptoms will better reflect the complexities encountered in clinical practice and may have pathological and therapeutic implications. We classified 1580 people with HIV based on 17 features, including 7 cognitive domains, 4 subscales of the Beck depression inventory-II, 5 components of the patient's assessment of own functioning inventory, and dependence in instrumental and basic activities of daily living. A two-stage clustering procedure consisting of dimension reduction with self-organizing maps and Mahalanobis distance-based k-means clustering algorithms was applied to cross-sectional data. Baseline demographic and clinical characteristics were compared between the phenotypes, and their prediction on the biopsychosocial phenotypes was evaluated using multinomial logistic regression. Four distinct phenotypes were identified. Participants in Phenotype 1 overall did well in all domains. Phenotype 2 had mild-to-moderate depressive symptoms and the most substance use disorders. Phenotype 3 had mild-to-moderate cognitive impairment, moderate depressive symptoms, and the worst daily functioning; they also had the highest proportion of females and non-HIV conditions that could affect cognition. Phenotype 4 had mild-to-moderate cognitive impairment but with relatively good mood, and daily functioning. Multivariable analysis showed that demographic characteristics, medical conditions, lifetime cocaine use disorder, triglycerides, and non-antiretroviral therapy medications were important variables associated with biopsychosocial phenotype. We found complex, multidimensional biopsychosocial profiles in people with HIV that were associated with different risk patterns. Future longitudinal work should determine the stability of these phenotypes, assess factors that influence transitions from one phenotype to another, and characterize their biological associations.

Mechanical Detection of Nuclear Decays.

We report the detection of individual nuclear α decays through the mechanical recoil of the entire micron-sized particle in which the decaying nuclei are embedded. Momentum conservation ensures that such measurements are sensitive to any particles emitted in the decay, including neutral particles that may otherwise evade detection with existing techniques. Detection of the minuscule recoil of an object more than 10^{12} times more massive than the emitted particles is made possible by recently developed techniques in levitated optomechanics, which enable high-precision optical control and measurement of the mechanical motion of optically trapped particles. Observation of a change in the net charge of the particle coincident with the recoil allows decays to be identified with background levels at the micro-Becquerel level. The techniques developed here may find use in fields ranging from nuclear forensics to dark matter and neutrino physics.

Social inflation and health care risk management.

This paper examines the concept of social inflation as it affects medical malpractice insurance claims, a phenomenon that warrants monitoring by risk managers in health care. The authors define social inflation as the growth in the cost of insurance claims that exceeds general inflation. The authors use data aggregated from insurance company Annual Statements and from a national database of malpractice reports to estimate that social inflation added $2.4 billion to $3.5 billion to booked losses over the 10 years ending in 2021, which is between 8% and 11% of total losses. The authors' approach is to show growth in loss development factors, a metric that property/casualty actuaries use to estimate claim costs. This approach is explained in detail. The paper concludes with commentary on how risk managers can incorporate consideration of social inflation in their overall assessment of risk.

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Minority Stress, Psychological Distress, Sexual Compulsivity, and Avoidance-Based Motivations Associated with Methamphetamine Use Among Sexual Minority Men Living with HIV: Examining Direct and Indirect Associations Using Cross-Sectional Structural Equation Modeling.

OBJECTIVE: Sexual minority men (SMM) living with HIV report significantly greater methamphetamine use compared with heterosexual and HIV-negative peers. Greater use may be related to stressors (e.g., HIV-related stigma) faced by SMM living with HIV and subsequent psychological and behavioral sequelae. We tested an integrated theoretical model comprised of pathways between stigma, discrimination, childhood sexual abuse, psychological distress, sexual compulsivity, and cognitive escape in predicting methamphetamine use among SMM living with HIV. METHODS: Among 423 SMM living with HIV, we tested a structural equation model examining factors hypothesized to be directly and indirectly associated with methamphetamine use. Analyses were adjusted for demographic covariates and sampling bias. RESULTS: The model showed good fit (CFI = 0.96, RMSEA = 0.01). Heterosexist discrimination was associated with psychological distress (ß = 0.39, p < 0.001) and psychological distress was associated with sexual compulsivity (ß = 0.33, p < 0.001). Sexual compulsivity was associated with cognitive escape (ß = 0.31, p < 0.001), which was associated with methamphetamine use (ß = 0.51, p < 0.001). Psychological distress was associated with methamphetamine use via serial indirect effects of sexual compulsivity and cognitive escape (ß = 0.05, p < 0.05). CONCLUSIONS: Heterosexist discrimination contributed to psychological distress among SMM living with HIV. Psychological distress is linked to methamphetamine use via sexual compulsivity and cognitive avoidance. Interventions seeking to reduce the likelihood that SMM living with HIV use methamphetamine should include coping strategies specific to heterosexism and related psychological distress.