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JMIR Research Protocols Jun 2024Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have...
BACKGROUND
Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.
OBJECTIVE
This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
METHODS
This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
RESULTS
The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
CONCLUSIONS
Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
TRIAL REGISTRATION
PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/51614.
Topics: Humans; Randomized Controlled Trials as Topic; Artificial Intelligence; Algorithms; Systematic Reviews as Topic; Patient Harm; Equipment and Supplies; Research Design
PubMed: 38941147
DOI: 10.2196/51614 -
JAMA Network Open Jun 2024Understanding the cost of drug development can help inform the development of policies to reduce costs, encourage innovation, and improve patient access to drugs.
IMPORTANCE
Understanding the cost of drug development can help inform the development of policies to reduce costs, encourage innovation, and improve patient access to drugs.
OBJECTIVE
To estimate the cost of drug development by therapeutic class and trends in pharmaceutical research and development (R&D) intensity over time.
DESIGN, SETTING, AND PARTICIPANTS
In this economic evaluation study, an analytical model of drug development constructed using public and proprietary sources that collectively cover data from 2000 to 2018 was used to estimate the cost of bringing a drug to market, overall and for specific therapeutic classes. The analysis for the study was completed in October 2020.
MAIN OUTCOMES AND MEASURES
Three measures of development cost from nonclinical through postmarketing stages were estimated: mean out-of-pocket cost or cash outlay, mean expected cost, and mean expected capitalized cost. Pharmaceutical R&D intensity, defined as the ratio of R&D spending to total sales, from 2008 to 2019, based on the time frame for available data, was also analyzed.
RESULTS
The estimated mean cost of developing a new drug was approximately $172.7 million (2018 dollars) (range, $72.5 million for genitourinary to $297.2 million for pain and anesthesia), inclusive of postmarketing studies. The cost increased to $515.8 million when cost of failures was included. When the costs of failures and capital were included, the mean expected capitalized cost of drug development increased to $879.3 million (range, $378.7 million for anti-infectives to $1756.2 million for pain and anesthesia); results varied widely by therapeutic class. The pharmaceutical industry as a whole experienced a decline of 15.6% in sales but increased R&D intensity from 11.9% to 17.7% from 2008 to 2019. By contrast, R&D intensity of large pharmaceutical companies increased from 16.6% to 19.3%, whereas sales increased by 10.0% (from $380.0 to $418.0 billion) over the same 2008 to 2019 period, even though the cost of drug development remained relatively stable or may have even decreased.
CONCLUSIONS AND RELEVANCE
In this economic evaluation of new drug development costs, even though the cost of drug development appears to have remained stable, R&D intensity of large pharmaceutical companies remained relatively unchanged, despite substantial growth in revenues during this period. These findings can inform the design of drug-related policies and their potential impacts on innovation and competition.
Topics: Drug Development; United States; Humans; Drug Costs; Drug Industry; Pharmaceutical Research
PubMed: 38941099
DOI: 10.1001/jamanetworkopen.2024.15445 -
JAMA Network Open Jun 2024Air pollution is a recognized risk factor associated with chronic diseases, including respiratory and cardiovascular conditions, which can lead to physical and cognitive...
IMPORTANCE
Air pollution is a recognized risk factor associated with chronic diseases, including respiratory and cardiovascular conditions, which can lead to physical and cognitive impairments in later life. Although these losses of function, individually or in combination, reduce individuals' likelihood of living independently, little is known about the association of air pollution with this critical outcome.
OBJECTIVE
To investigate associations between air pollution and loss of independence in later life.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study was conducted as part of the Environmental Predictors Of Cognitive Health and Aging study and used 1998 to 2016 data from the Health and Retirement Study. Participants included respondents from this nationally representative, population-based cohort who were older than 50 years and had not previously reported a loss of independence. Analyses were performed from August 31 to October 15, 2023.
EXPOSURES
Mean 10-year pollutant concentrations (particulate matter less than 2.5 μm in diameter [PM2.5] or ranging from 2.5 μm to 10 μm in diameter [PM10-2.5], nitrogen dioxide [NO2], and ozone [O3]) were estimated at respondent addresses using spatiotemporal models along with PM2.5 levels from 9 emission sources.
MAIN OUTCOMES AND MEASURES
Loss of independence was defined as newly receiving care for at least 1 activity of daily living or instrumental activity of daily living due to health and memory problems or moving to a nursing home. Associations were estimated with generalized estimating equation regression adjusting for potential confounders.
RESULTS
Among 25 314 respondents older than 50 years (mean [SD] baseline age, 61.1 [9.4] years; 11 208 male [44.3%]), 9985 individuals (39.4%) experienced lost independence during a mean (SD) follow-up of 10.2 (5.5) years. Higher exposure levels of mean concentration were associated with increased risks of lost independence for total PM2.5 levels (risk ratio [RR] per 1-IQR of 10-year mean, 1.05; 95% CI, 1.01-1.10), PM2.5 levels from road traffic (RR per 1-IQR of 10-year mean, 1.09; 95% CI, 1.03-1.16) and nonroad traffic (RR per 1-IQR of 10-year mean, 1.13; 95% CI, 1.03-1.24), and NO2 levels (RR per 1-IQR of 10-year mean, 1.05; 95% CI, 1.01-1.08). Compared with other sources, traffic-generated pollutants were most consistently and robustly associated with loss of independence; only road traffic-related PM2.5 levels remained associated with increased risk after adjustment for PM2.5 from other sources (RR per 1-IQR increase in 10-year mean concentration, 1.10; 95% CI, 1.00-1.21). Other pollutant-outcome associations were null, except for O3 levels, which were associated with lower risks of lost independence (RR per 1-IQR increase in 10-year mean concentration, 0.94; 95% CI, 0.92-0.97).
CONCLUSIONS AND RELEVANCE
This study found that long-term exposure to air pollution was associated with the need for help for lost independence in later life, with especially large and consistent increases in risk for pollution generated by traffic-related sources. These findings suggest that controlling air pollution could be associated with diversion or delay of the need for care and prolonged ability to live independently.
Topics: Humans; Male; Aged; Female; Air Pollution; Middle Aged; United States; Particulate Matter; Environmental Exposure; Air Pollutants; Cohort Studies; Ozone; Independent Living; Nitrogen Dioxide; Aged, 80 and over; Risk Factors
PubMed: 38941096
DOI: 10.1001/jamanetworkopen.2024.18460 -
JAMA Network Open Jun 2024While adults aged 80 years and older account for 70% of hip fractures in the US, performance of fracture risk assessment tools in this population is uncertain.
IMPORTANCE
While adults aged 80 years and older account for 70% of hip fractures in the US, performance of fracture risk assessment tools in this population is uncertain.
OBJECTIVE
To compare performance of the Fracture Risk Assessment Tool (FRAX), Garvan Fracture Risk Calculator, and femoral neck bone mineral density (FNBMD) alone in 5-year hip fracture prediction.
DESIGN, SETTING AND PARTICIPANTS
Prognostic analysis of 3 prospective cohort studies including participants attending an index examination (1997 to 2016) at age 80 years or older. Data were analyzed from March 2023 to April 2024.
MAIN OUTCOMES AND MEASURES
Participants contacted every 4 or 6 months after index examination to ascertain incident hip fractures and vital status. Predicted 5-year hip fracture probabilities calculated using FRAX and Garvan models incorporating FNBMD and FNBMD alone. Model discrimination assessed by area under receiver operating characteristic curve (AUC). Model calibration assessed by comparing observed vs predicted hip fracture probabilities within predicted risk quintiles.
RESULTS
A total of 8890 participants were included, with a mean (SD) age at index examination of 82.6 (2.7) years; 4906 participants (55.2%) were women, 866 (9.7%) were Black, 7836 (88.1%) were White, and 188 (2.1%) were other races and ethnicities. During 5-year follow-up, 321 women (6.5%) and 123 men (3.1%) experienced a hip fracture; 818 women (16.7%) and 921 men (23.1%) died before hip fracture. Among women, AUC was 0.69 (95% CI, 0.67-0.72) for FRAX, 0.69 (95% CI, 0.66-0.72) for Garvan, and 0.72 (95% CI, 0.69-0.75) for FNBMD alone (FNBMD superior to FRAX, P = .01; and Garvan, P = .01). Among men, AUC was 0.71 (95% CI, 0.66-0.75) for FRAX, 0.76 (95% CI, 0.72-0.81) for Garvan, and 0.77 (95% CI, 0.72-0.81) for FNBMD alone (P < .001 Garvan and FNBMD alone superior to FRAX). Among both sexes, Garvan greatly overestimated hip fracture risk among individuals in upper quintiles of predicted risk, while FRAX modestly underestimated risk among those in intermediate quintiles of predicted risk.
CONCLUSIONS AND RELEVANCE
In this prognostic study of adults aged 80 years and older, FRAX and Garvan tools incorporating FNBMD compared with FNBMD alone did not improve 5-year hip fracture discrimination. FRAX modestly underpredicted observed hip fracture probability in intermediate-risk individuals. Garvan markedly overpredicted observed hip fracture probability in high-risk individuals. Until better prediction tools are available, clinicians should prioritize consideration of hip BMD, life expectancy, and patient preferences in decision-making regarding drug treatment initiation for hip fracture prevention in late-life adults.
Topics: Humans; Hip Fractures; Male; Female; Risk Assessment; Aged, 80 and over; Prospective Studies; Bone Density; Risk Factors; Femur Neck
PubMed: 38941095
DOI: 10.1001/jamanetworkopen.2024.18612 -
JAMA Network Open Jun 2024Studies on the familial effects of body mass index (BMI) status have yielded a wide range of data on its heritability.
IMPORTANCE
Studies on the familial effects of body mass index (BMI) status have yielded a wide range of data on its heritability.
OBJECTIVE
To assess the heritability of obesity by measuring the association between the BMIs of fathers, mothers, and their offspring at the same age.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study used data from population-wide mandatory medical screening before compulsory military service in Israel. The study included participants examined between January 1, 1986, and December 31, 2018, whose both parents had their BMI measurement taken at their own prerecruitment evaluation in the past. Data analysis was performed from May to December 2023.
MAIN OUTCOMES AND MEASURES
Spearman correlation coefficients were calculated for offsprings' BMI and their mothers', fathers', and midparental BMI percentile (the mean of the mothers' and fathers' BMI cohort- and sex-specific BMI percentile) to estimate heritability. Logistic regression models were applied to estimate the odds ratios (ORs) and 95% CIs of obesity compared with healthy BMI, according to parental BMI status.
RESULTS
A total of 447 883 offspring (235 105 male [52.5%]; mean [SD] age, 17.09 [0.34] years) with both parents enrolled and measured for BMI at 17 years of age were enrolled in the study, yielding a total study population of 1 343 649 individuals. Overall, the correlation between midparental BMI percentile at 17 years of age and the offspring's BMI at 17 years of age was moderate (ρ = 0.386). Among female offspring, maternal-offspring BMI correlation (ρ = 0.329) was somewhat higher than the paternal-offspring BMI correlation (ρ = 0.266). Among trios in which both parents had a healthy BMI, the prevalence of overweight or obesity in offspring was 15.4%; this proportion increased to 76.6% when both parents had obesity and decreased to 3.3% when both parents had severe underweight. Compared with healthy weight, maternal (OR, 4.96; 95% CI, 4.63-5.32), paternal (OR, 4.48; 95% CI, 4.26-4.72), and parental (OR, 6.44; 95% CI, 6.22-6.67) obesity (midparent BMI in the ≥95th percentile) at 17 years of age were associated with increased odds of obesity among offspring.
CONCLUSIONS AND RELEVANCE
In this cohort study of military enrollees whose parents also underwent prerecruitment evaluations, the observed correlation between midparental and offspring BMI, coupled with a calculated narrow-sense heritability of 39%, suggested a substantive contribution of genetic factors to BMI variation at 17 years of age.
Topics: Humans; Body Mass Index; Male; Female; Israel; Adolescent; Obesity; Cohort Studies; Adult; Fathers
PubMed: 38941093
DOI: 10.1001/jamanetworkopen.2024.19029 -
Alternative Therapies in Health and... Jun 2024Medicine logistics, particularly cryogenic storage, maintains pharmaceutical efficacy and safety. Ensuring seamless transportation and storage prevents spoilage,...
BACKGROUND
Medicine logistics, particularly cryogenic storage, maintains pharmaceutical efficacy and safety. Ensuring seamless transportation and storage prevents spoilage, degradation, or contamination, safeguarding patient health.
OBJECTIVE
This study aimed to analyze the relationships among the components of the medication cold chain logistics system using grey relational analysis (GRA). Additionally, we utilized GRA to construct an adjacency matrix, facilitating a comprehensive understanding of the interdependencies within the system.
METHODS
Data from pertinent indices spanning 2021 and 2022 were utilized to conduct a quantitative analysis using GRA. This analysis aimed to identify the most influential elements affecting the growth of pharmaceutical cold chain logistics in a specific location. The negative aspects of the medication cold chain logistics system in particular areas were examined by assessing the grey relationship grades between various components and the medicine cold chain logistics system in those regions.
RESULTS
The analysis revealed significant insights into the correlated risk factors impacting medicine logistics operations. Through an examination of the financial status and operational processes of medicine logistics assets, four categories of risks were identified, encompassing transportation, storage, distribution, and quality management. These categories were established by analyzing the most significant risk factors across these operational domains. Additionally, GRA was employed to assess the factors influencing medicine logistics. The study found a strong relationship between key parameters, such as transportation risk and site facilities and equipment, and the growth of the pharmaceutical logistics sector. Operation risk emerged as the least influential factor, while site facilities and equipment, transportation risk, and operation risk demonstrated substantial influence on the region's medical logistics sector growth.
CONCLUSION
This study provides important recommendations to improve medicine logistics, aiming to mitigate adverse effects and elevate inventory management. Implementation can enhance efficiency and safety in the medicine supply chain, benefiting patient care and public health.
PubMed: 38940801
DOI: No ID Found -
Journal of the Korean Association of... Jun 2024Dentoalveolar (DA) trauma, which can involve tooth, alveolar bone, and surrounding soft tissues, is a significant dentofacial emergency. In emergency settings,...
Dentoalveolar (DA) trauma, which can involve tooth, alveolar bone, and surrounding soft tissues, is a significant dentofacial emergency. In emergency settings, physicians might lack comprehensive knowledge of timely procedures, causing delays for specialist referral. This systematic review assesses the literature on isolated DA fractures, emphasizing intervention timing and splinting techniques and duration in both children and adults. This systematic review adhered to PRISMA guidelines and involved a thorough search across PubMed, Google Scholar, Semantic Scholar, and the Cochrane Library from January 1980 to December 2022. Inclusion and exclusion criteria guided study selection, with data extraction and analysis centered on demographics, etiology, injury site, diagnostics, treatment timelines, and outcomes in pediatric (2-12 years) and adult (>12 years) populations. This review analyzed 26 studies, categorized by age into pediatrics (2-12 years) and adults (>12 years). Falls were a common etiology, primarily affecting the anterior maxilla. Immediate management involved replantation, repositioning, and splinting within 24 hours (pediatric) or 48 hours (adult). Composite resin-bonded splints were common. Endodontic treatment was done within a timeframe of 3 days to 12 weeks for children and 2-12 weeks for adults. Tailored management based on patient age, tooth development stage, time elapsed, and resource availability is essential.
PubMed: 38940648
DOI: 10.5125/jkaoms.2024.50.3.123 -
Journal of Global Health Jun 2024Understanding chronic disease prevalence, patterns, and co-occurrence is pivotal for effective health care planning and disease prevention strategies. In this paper, we...
BACKGROUND
Understanding chronic disease prevalence, patterns, and co-occurrence is pivotal for effective health care planning and disease prevention strategies. In this paper, we aimed to identify the clustering of major non-communicable diseases among Indian adults aged ≥50 years based on their self-reported diagnosed non-communicable disease status and to find the risk factors that heighten the risk of developing the identified disease clusters.
METHODS
We utilised data from the nationally representative survey Study on Global AGEing and Adult Health (SAGE Wave-2). The eligible sample size was 6298 adults aged ≥50 years. We conducted the latent class analysis to uncover latent subgroups of multimorbidity and the multinomial logistic regression to identify the factors linked to observed latent class membership.
RESULTS
The latent class analysis grouped our sample of men and women >49 years old into three groups - mild multimorbidity risk (41%), moderate multimorbidity risk (30%), and severe multimorbidity risk (29%). In the mild multimorbidity risk group, the most prevalent diseases were asthma and arthritis, and the major prevalent disease in the moderate multimorbidity risk group was low near/distance vision, followed by depression, asthma, and lung disease. Angina, diabetes, hypertension, and stroke were the major diseases in the severe multimorbidity risk category. Individuals with higher ages had an 18% and 15% higher risk of having moderate multimorbidity and severe multimorbidity compared to those in the mild multimorbidity category. Females were more likely to have a moderate risk (3.36 times) and 2.82 times more likely to have severe multimorbidity risk.
CONCLUSIONS
The clustering of diseases highlights the importance of integrated disease management in primary care settings and improving the health care system to accommodate the individual's needs. Implementing preventive measures and tailored interventions, strengthening the health and wellness centres, and delivering comprehensive primary health care services for secondary and tertiary level hospitalisation may cater to the needs of multimorbid patients.
Topics: Humans; Female; Male; India; Middle Aged; Chronic Disease; Aged; Risk Factors; Multimorbidity; Cluster Analysis; Latent Class Analysis; Prevalence; Noncommunicable Diseases; Health Surveys
PubMed: 38940270
DOI: 10.7189/jogh.14.04079 -
Polish Archives of Internal Medicine Jun 2024This narrative review summarizes the current body of literature regarding the periprocedural management of direct anticoagulants (DOACs) for patients undergoing...
This narrative review summarizes the current body of literature regarding the periprocedural management of direct anticoagulants (DOACs) for patients undergoing digestive endoscopy since the publication of the 2022 American College of Gastroenterology - Canadian Association of Gastroenterology guidelines. We provide a detailed analysis of TE risk, endoscopic procedure-specific bleeding risks, contemporary intra-procedural techniques to reduce bleeding risk, and a summary of major gastrointestinal societies' periprocedural DOAC guidelines, including procedure risk stratification. While there exists heterogeneity in the data, the overall trend of the current literature supports the contemporary practice of a minimal DOAC interruption without the need for heparin bridging.
PubMed: 38940268
DOI: 10.20452/pamw.16781 -
JACC. Advances Jan 2024Low-density lipoprotein cholesterol (LDL-C) is used to guide lipid-lowering therapy after a myocardial infarction (MI). Lack of LDL-C testing represents a missed...
BACKGROUND
Low-density lipoprotein cholesterol (LDL-C) is used to guide lipid-lowering therapy after a myocardial infarction (MI). Lack of LDL-C testing represents a missed opportunity for optimizing therapy and reducing cardiovascular risk.
OBJECTIVES
The purpose of this study was to estimate the proportion of Medicare beneficiaries who had their LDL-C measured within 90 days following MI hospital discharge.
METHODS
We conducted a retrospective cohort study of Medicare beneficiaries ≥66 years of age with an MI hospitalization between 2016 and 2020. The primary analysis used data from all beneficiaries with fee-for-service coverage and pharmacy benefits (532,767 MI hospitalizations). In secondary analyses, we used data from a 5% random sample of beneficiaries with fee-for-service coverage without pharmacy benefits (10,394 MI hospitalizations), and from beneficiaries with Medicare Advantage (176,268 MI hospitalizations). The proportion of beneficiaries who had their LDL-C measured following MI hospital discharge was estimated accounting for the competing risk of death.
RESULTS
In the primary analysis (mean age 76.9 years, 84.4% non-Hispanic White), 29.9% of beneficiaries had their LDL-C measured within 90 days following MI hospital discharge. Among Hispanic, Asian, non-Hispanic White, and non-Hispanic Black beneficiaries, the 90-day postdischarge LDL-C testing was 33.8%, 32.5%, 30.0%, and 26.0%, respectively. Postdischarge LDL-C testing within 90 days was highest in the Middle Atlantic (36.4%) and lowest in the West North Central (23.4%) U.S. regions. In secondary analyses, the 90-day postdischarge LDL-C testing was 26.9% among beneficiaries with fee-for-service coverage without pharmacy benefits, and 28.6% among beneficiaries with Medicare Advantage coverage.
CONCLUSIONS
LDL-C testing following MI hospital discharge among Medicare beneficiaries was low.
PubMed: 38939806
DOI: 10.1016/j.jacadv.2023.100753