Bridging the literacy gap for surgical consents: an AI-human expert collaborative approach.

Despite the importance of informed consent in healthcare, the readability and specificity of consent forms often impede patients' comprehension. This study investigates the use of GPT-4 to simplify surgical consent forms and introduces an AI-human expert collaborative approach to validate content appropriateness. Consent forms from multiple institutions were assessed for readability and simplified using GPT-4, with pre- and post-simplification readability metrics compared using nonparametric tests. Independent reviews by medical authors and a malpractice defense attorney were conducted. Finally, GPT-4's potential for generating de novo procedure-specific consent forms was assessed, with forms evaluated using a validated 8-item rubric and expert subspecialty surgeon review. Analysis of 15 academic medical centers' consent forms revealed significant reductions in average reading time, word rarity, and passive sentence frequency (all P < 0.05) following GPT-4-faciliated simplification. Readability improved from an average college freshman to an 8th-grade level (P = 0.004), matching the average American's reading level. Medical and legal sufficiency consistency was confirmed. GPT-4 generated procedure-specific consent forms for five varied surgical procedures at an average 6th-grade reading level. These forms received perfect scores on a standardized consent form rubric and withstood scrutiny upon expert subspeciality surgeon review. This study demonstrates the first AI-human expert collaboration to enhance surgical consent forms, significantly improving readability without sacrificing clinical detail. Our framework could be extended to other patient communication materials, emphasizing clear communication and mitigating disparities related to health literacy barriers.

High-dose, short-duration versus standard rifampicin for tuberculosis preventive treatment: a partially blinded, three-arm, non-inferiority, randomised, controlled trial.

BACKGROUND: Tuberculosis preventive treatment (TPT) is a key component of tuberculosis elimination. To improve completion and reduce the burden for people and health systems, short, safe, and effective TPT regimens are needed. We aimed to compare safety and treatment completion of various doses and durations of rifampicin in people who were recommended to receive TPT. METHODS: This partially blinded, parallel-arm, non-inferiority, randomised, controlled, phase 2b trial was done at seven university-affiliated clinics in Canada, Indonesia, and Viet Nam. Participants aged 10 years or older were included if they had an indication for TPT according to WHO guidelines for Indonesia and Viet Nam, or Canadian guidelines for Canadian sites, and a positive tuberculin skin test or interferon-γ release assay. Participants were randomly assigned (1:1:1) to receive oral rifampicin at 10 mg/kg once daily for 4 months (standard-dose group), 20 mg/kg daily for 2 months (20 mg/kg group), or 30 mg/kg daily for 2 months (30 mg/kg group). The randomisation sequence was computer generated with blocks of variable size (three, six, and nine) and stratified by country for Indonesia and Viet Nam, and by city within Canada. Participants and investigators were masked to dose in high-dose groups, but unmasked to duration in all groups. The two co-primary outcomes were safety (in the safety population, in which participants received at least one dose of the study drug) and treatment completion (in the modified intention-to-treat [mITT] population, excluding those ineligible after randomisation). Protocol-defined adverse events were defined as grade 3 or worse, or rash or allergy of any grade, judged by an independent and masked panel as possibly or probably related to the study. A margin of 4% was used to assess non-inferiority. This study is registered with ClinicalTrials.gov, NCT03988933 (active). RESULTS: Between Sept 1, 2019, and Sept 30, 2022, 1692 people were assessed for eligibility, 1376 were randomly assigned, and eight were excluded after randomisation. 1368 participants were included in the mITT population (454 in the standard group, 461 in the 20 mg/kg group, and 453 in the 30 mg/kg group). 589 (43%) participants were male and 779 (57%) were female. 372 (82%) in the standard-dose group, 329 (71%) in the 20 mg/kg group, and 293 (65%) in the 30 mg/kg group completed treatment. No participants in the standard-dose group, one (<1%) of 441 participants in the 20 mg/kg group, and four (1%) of 423 in the 30 mg/kg group developed grade 3 hepatotoxicity. Risk of protocol-defined adverse events was higher in the 30 mg/kg group than in the standard-dose group (adjusted risk difference 4·6% [95% CI 1·8 to 7·4]) or the 20 mg/kg group (5·1% [2·3 to 7·8]). There was no difference in the risk of adverse events between the 20 mg/kg and standard-dose groups (-0·5% [95% CI -2·4 to 1·5]; non-inferiority met). Completion was lower in the 20 mg/kg group (-7·8% [95% CI -13·6 to -2·0]) and the 30 mg/kg group (-15·4% [-21·4 to -9·4]) than in the standard-dose group. INTERPRETATION: In this trial, 2 months of 30 mg/kg daily rifampicin had significantly worse safety and completion than 4 months of 10 mg/kg daily and 2 months of 20 mg/kg daily (the latter, a fully blinded comparison); we do not consider 30 mg/kg to be a good option for TPT. Rifampicin at 20 mg/kg daily for 2 months was as safe as standard treatment, but with lower completion. This difference remains unexplained. FUNDING: Canadian Institutes of Health Research.

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19).

OBJECTIVE: Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19. DESIGN: Phase 2a randomised, placebo-controlled, double-blinded, trial. SETTING: Hospitals in Canada, Turkey and the USA. PARTICIPANTS: A total of 61 subjects with moderate-to-severe COVID-19. INTERVENTIONS: Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers. RESULTS: At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups. CONCLUSION: In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19. TRIAL REGISTRATION NUMBER: NCT04402957.

Demographic Representation in 3 Leading Artificial Intelligence Text-to-Image Generators.

Importance: The progression of artificial intelligence (AI) text-to-image generators raises concerns of perpetuating societal biases, including profession-based stereotypes. Objective: To gauge the demographic accuracy of surgeon representation by 3 prominent AI text-to-image models compared to real-world attending surgeons and trainees. Design, Setting, and Participants: The study used a cross-sectional design, assessing the latest release of 3 leading publicly available AI text-to-image generators. Seven independent reviewers categorized AI-produced images. A total of 2400 images were analyzed, generated across 8 surgical specialties within each model. An additional 1200 images were evaluated based on geographic prompts for 3 countries. The study was conducted in May 2023. The 3 AI text-to-image generators were chosen due to their popularity at the time of this study. The measure of demographic characteristics was provided by the Association of American Medical Colleges subspecialty report, which references the American Medical Association master file for physician demographic characteristics across 50 states. Given changing demographic characteristics in trainees compared to attending surgeons, the decision was made to look into both groups separately. Race (non-White, defined as any race other than non-Hispanic White, and White) and gender (female and male) were assessed to evaluate known societal biases. Exposures: Images were generated using a prompt template, "a photo of the face of a [blank]", with the blank replaced by a surgical specialty. Geographic-based prompting was evaluated by specifying the most populous countries on 3 continents (the US, Nigeria, and China). Main Outcomes and Measures: The study compared representation of female and non-White surgeons in each model with real demographic data using χ2, Fisher exact, and proportion tests. Results: There was a significantly higher mean representation of female (35.8% vs 14.7%; P < .001) and non-White (37.4% vs 22.8%; P < .001) surgeons among trainees than attending surgeons. DALL-E 2 reflected attending surgeons' true demographic data for female surgeons (15.9% vs 14.7%; P = .39) and non-White surgeons (22.6% vs 22.8%; P = .92) but underestimated trainees' representation for both female (15.9% vs 35.8%; P < .001) and non-White (22.6% vs 37.4%; P < .001) surgeons. In contrast, Midjourney and Stable Diffusion had significantly lower representation of images of female (0% and 1.8%, respectively; P < .001) and non-White (0.5% and 0.6%, respectively; P < .001) surgeons than DALL-E 2 or true demographic data. Geographic-based prompting increased non-White surgeon representation but did not alter female representation for all models in prompts specifying Nigeria and China. Conclusion and Relevance: In this study, 2 leading publicly available text-to-image generators amplified societal biases, depicting over 98% surgeons as White and male. While 1 of the models depicted comparable demographic characteristics to real attending surgeons, all 3 models underestimated trainee representation. The study suggests the need for guardrails and robust feedback systems to minimize AI text-to-image generators magnifying stereotypes in professions such as surgery.

Associations between season, climate, and pediatric alopecia areata flares in Providence, Rhode Island.

Patients with alopecia areata (AA) may experience episodic hair loss that follows seasonal patterns. To assess associations between seasonal variation, climate factors, and AA flare frequency in pediatric AA patients, we performed a retrospective chart review of 123 pediatric AA patients at Brown Dermatology (Providence, Rhode Island) who experienced hair loss between January 2017 and December 2019. We assessed association of seasonal variation with monthly occurrence of AA flares. We then assessed association between climate variables and monthly AA hair loss frequency using Spearman rank correlation analyses. We conducted stratified analyses in patients with and without history of atopy. The greatest proportion of hair loss episodes occurred in winter (28.1%), followed by autumn (26.3%), spring (23.8%), and summer (21.7%). We found significant correlations between AA hair loss frequency and air pressure (R = 0.61) and hours of sunlight (R = - 0.60). These correlations remained significant among patients with no history of atopic disease but were not significant among those with history of atopy. Limitations include small sample size. This regional analysis supports the role of climate in AA hair loss episodes through assessment of seasonal occurrences and identification of correlations between climate characteristics and AA flare frequency.

Characterizing long-COVID brain fog: a retrospective cohort study.

BACKGROUND: Long COVID or post-COVID condition (PCC) is a common complication following acute COVID-19 infection. PCC is a multi-systems disease with neurocognitive impairment frequently reported regardless of age. Little is known about the risk factors, associated biomarkers and clinical trajectory of patients with this symptom. OBJECTIVE: To determine differences in clinical risk factors, associated biochemical markers and longitudinal clinical trajectories between patients with PCC with subjective neurocognitive symptoms (NC+) or without (NC-). METHODS: A retrospective longitudinal cohort study was performed using a well-characterized provincial database of patients with clinically confirmed PCC separated into NC+ and NC- cohorts. Demographical, clinical and biochemical differences at initial consultation between the two patient cohorts were analyzed in cross-section. Multivariate regression analyses were conducted to identify independent risk factors for neurocognitive impairment. Determination of the recovery trajectory was performed using serial assessments of the patient-reported health-related quality of life (HR-QoL) metric Eq-5D-5L-vas score. FINDINGS: Women, milder acute infection and pre-existing mental health diagnoses were independently associated with subjective neurocognitive impairment at 8 months post-infection. NC + patients demonstrated lower levels of IgG, IgG1 and IgG3 compared to NC- patients. The NC + cohort had poorer HR-QoL at initial consultation 8 months post-infection with gradual improvement over 20 months post-infection. CONCLUSIONS: Neurocognitive impairment represents a severe phenotype of PCC, associated with unique risk factors, aberrancy in immune response and a delayed recovery trajectory. Those with risk factors for neurocognitive impairment can be identified early in the disease trajectory for more intense medical follow-up.

A critical review of COVID-19 course and vaccination in dermatology patients on immunomodulatory/biologic therapy: recommendations should not differ between non-pregnant and pregnant individuals.

COVID-19 can have detrimental effects on immunosuppressed patients. Here, we evaluate the evidence regarding continuing immunomodulatory/biologic (IMBI) therapy in pregnant dermatology patients during the COVID-19 pandemic. Also, we discuss the risks of COVID-19 vaccination in pregnant dermatology patients on IMBI therapy. As indicated in this review, regarding continuing IMBI therapy in pregnant dermatology patients during the pandemic, there is no compelling reason for treating them differently than non-pregnant. The body of evidence indicates that mRNA COVID-19 vaccines are safe during pregnancy. Studies on rheumatology patients, a group that overlaps significantly with the dermatology group, provided essential findings. IMBI in a non-pregnant rheumatology patient was not associated with COVID-19 mortality (except for rituximab), and vaccination of the rheumatology patient during pregnancy improved the obstetric outcomes compared to the unvaccinated patient. Based on this data, it can be stated that after weighing the benefit-risk profile of the available COVID-19 vaccines, the recommendation for the pregnant dermatology patient speaks in favor of the COVID-19 vaccination. COVID-19 vaccine recommendations in pregnant dermatology patients on IMBI should not differ from those for their non-pregnant counterparts.

Assessment of factors and interventions towards therapeutic adherence among persons with non-cystic fibrosis bronchiectasis.

Non-cystic fibrosis bronchiectasis (NCFB) is a highly prevalent chronic respiratory disease with substantial burden to both patients and healthcare systems. Persons with NCFB (pwNCFB) are often given complex acute and chronic treatment regimens consisting of medications, airway clearance techniques and exercise. Accordingly, the high burden in NCFB has contributed to lower therapy adherence, with estimates of 53% to medications, 41% to airway clearance and only 16% to all prescribed therapy. Consequent clinical outcomes from lower adherence include reduced quality of life, accelerated lung function decline and recurrent pulmonary exacerbations. In this narrative review, we explore the impact of multifactorial mechanisms underpinning adherence in NCFB and evaluate the available evidence towards interventions to improve uptake of therapy as demonstrated in other chronic respiratory diseases. A holistic approach, starting with a careful review of patient adherence at regular intervals, may increase the success of multidimensional therapeutic interventions in pwNCFB, but robust ongoing studies are an area of need in this population.

Quality of life, respiratory symptoms, and health care utilization 1 year following outpatient management of COVID-19: a prospective cohort study.

The long-term impact of COVID-19 among those with mild infections is not well characterized. Among 81 adults who completed online assessments at 3- and 12-months following infection, quality of life scores did not significantly improve over time. Among 62 subjects who also completed telephone interviews, respiratory symptoms or exercise limitation were reported by 42% at a median follow-up of 387 days (IQR 251-402 days). Those with persistent respiratory symptoms scored lower on the EQ-5D visual analog score compared to those without. Persistent respiratory symptoms were associated with a lower likelihood of full-time employment at 1 year (aOR 0.09, 95%CI 0.01-0.91; P = 0.041). In an adjusted linear regression, persistent respiratory symptoms (P = 0.037) and female sex (P = 0.016) were both independent risks for increased visits to a primary care provider. This cohort study demonstrates that respiratory symptoms are frequent at 1 year following COVID-19 and more importantly, are associated with negative impacts on employment, quality of life, and health care utilization. Further research is needed to determine the pathophysiology and risk factors for persistent symptoms as well as optimal management strategies to improve the level of functioning and quality of life.

Predictors of Vitamin D Insufficiency in Children and Adolescents With Alopecia Areata.

INTRODUCTION: Limited data regarding predictors of vitamin D deficiency in US children exist. We aimed to identify predictors of vitamin D insufficiency among children with alopecia areata. METHODS: The medical records of 439 pediatric patients diagnosed with alopecia areata (AA) between January 2015 and December 2017 were reviewed. Those with 25-hydroxyvitamin D levels and no documented vitamin supplementation, chronic illness, or other autoimmune comorbidities other than AA were included. Demographic data, Fitzpatrick skin type, and the month of blood collection were recorded. Monthly UV index information from Philadelphia, PA corresponding to the month of blood collection was also collected. RESULTS: Within our cohort, 60.4% of patients had insufficient vitamin D levels, of which 38.2% were deficient. The mean age was nine years old. In multivariate analyses, higher Fitzpatrick skin type, non-summer season, and non-White race were associated with vitamin D insufficiency, while the monthly UV index was inversely associated. DISCUSSION/CONCLUSION: Higher Fitzpatrick skin type, non-summer season, and non-White race may be associated with vitamin D insufficiency in US pediatric patients. Larger studies are warranted to replicate our findings and fully evaluate predictors of pediatric vitamin D deficiency in the US.

Coffee consumption and risk of renal cancer: a meta-analysis of cohort evidence.

PURPOSE: There is increasing evidence that coffee consumption is related to reduced risks for some cancers, but the evidence for renal cancer is inconclusive. Therefore, we conducted a meta-analysis to summarize the cohort evidence of this relationship. METHODS: A literature search was performed in PubMed and Embase through February 2021. Meta-analyses using a random effects model were conducted for reported relative risk estimates (RRs) relating coffee intake and renal cancer incidence or mortality. We also performed a two-stage random effects exposure-response meta-analysis. Between-study heterogeneity was assessed. RESULTS: In a meta-analysis of the ten identified cohort studies, we found a summary RR of 0.88 [95% confidence interval (CI) 0.78-0.99] relating the highest vs. the lowest category of coffee intake and renal cancer, with no significant between-study heterogeneity observed (I2 = 35%, p = 0.13). This inverse association remained among studies of incident cancers (RR 0.85, 95% CI 0.76-0.96) and studies adjusting for smoking and body mass index (RR 0.87, 95% CI 0.77-0.99). CONCLUSIONS: Our findings from this meta-analysis of the published cohort evidence are suggestive of an inverse association between coffee consumption and renal cancer risk.

Acceptability and uptake of HIV self-testing in emergency care settings: A systematic review and meta-analysis.

BACKGROUND: Emergency departments (ED) interface with large numbers of patients that are often missed by conventional HIV testing approaches. ED-based HIV self-testing (HIVST) is an innovative engagement approach which has potential for testing gains among populations that have failed to be reached. This systematic review and meta-analysis evaluated acceptability and uptake of HIVST, as compared to standard provider-delivered testing approaches, among patients seeking care in ED settings. METHODS: Six electronic databases were systematically searched (Dates: January 1990-May 2021). Reports with data on HIVST acceptability and/or testing uptake in ED settings were included. Two reviewers identified eligible records (κ= 0.84); quality was assessed using formalized criteria. Acceptability and testing uptake metrics were summarized, and pooled estimates were calculated using random-effects models with assessments of heterogeneity. RESULTS: Of 5773 records identified, seven met inclusion criteria. The cumulative sample was 1942 subjects, drawn from three randomized control trials (RCTs) and four cross-sectional studies. Four reports assessed HIVST acceptability. Pooled acceptability of self-testing was 92.6% (95% confidence interval [CI]: 88.0%-97.1%). Data from two RCTs demonstrated that HIVST significantly increased testing uptake as compared to standard programs (risk ratio [RR] = 4.41, 95% CI: 1.95-10.10, I2  = 25.8%). Overall, the quality of evidence was low (42.9%) or very low (42.9%), with one report of moderate quality (14.2%). CONCLUSIONS: Available data indicate that HIVST may be acceptable and may increase testing among patients seeking emergency care, suggesting that expanding ED-based HIVST programs could enhance HIV diagnosis. However, given the limitations of the reports, additional research is needed to better inform the evidence base.

Evaluating hemoptysis hospitalizations among patients with bronchiectasis in the United States: a population-based cohort study.

BACKGROUND: The burden of hospitalizations and mortality for hemoptysis due to bronchiectasis is not well characterized. The primary outcome of our study was to evaluate in-hospital mortality in patients admitted with hemoptysis and bronchiectasis, as well as the rates of bronchial artery embolization, length of stay, and hospitalization costs. METHODS: The authors queried the Nationwide Inpatient Sample (NIS) claims database for hospitalizations between 2016 and 2017 using the ICD-10-CM codes for hemoptysis and bronchiectasis in the United States. Multivariable regression was used to evaluate predictors of in-hospital mortality, embolization, length of stay, and hospital costs. RESULTS: There were 8240 hospitalizations (weighted) for hemoptysis in the United States from 2016 to 2017. The overall in-hospital mortality was 4.5%, but higher in males compared to females. Predictors of in-hospital mortality included undergoing three or more procedures, age, and congestive heart failure. Bronchial artery embolization (BAE) was utilized during 2.1% of hospitalizations and was more frequently used in those with nontuberculous mycobacteria and aspergillus infections, but not pseudomonal infections. The mean length of stay was 6 days and the median hospitalization cost per patient was USD $9,610. Having comorbidities and procedures was significantly associated with increased length of stay and costs. CONCLUSION: Hemoptysis is a frequent indication for hospitalization among the bronchiectasis population. In-hospital death occurred in approximately 4.5% of hospitalizations. The effectiveness of BAE in treating and preventing recurrent hemoptysis from bronchiectasis needs to be explored.