JAMA Network Open最新文献

Importance: Digital health in biomedical research and its expanding list of potential clinical applications are rapidly evolving. A combination of new digital health technologies (DHTs), novel uses of existing DHTs through artificial intelligence- and machine learning-based algorithms, and improved integration and analysis of data from multiple sources has enabled broader use and delivery of these tools for research and health care purposes. The aim of this study was to assess the growth and overall trajectory of DHT funding through a National Institutes of Health (NIH)-wide grant portfolio analysis.

Observations: This study used 21 preselected DHT search terms to identify the funding allocations in DHT research across a 9-year period between fiscal year 2015 and fiscal year 2023. A subset of grants were manually curated to confirm the search terms' accuracy and ascertain the stage of development, focus, and types of tools or approaches. To understand the translation of DHTs from biomedical research to clinical application, common measures, such as digital health publications and clinical trials were included. The DHT portfolio represented 3.2% (US $7 628 967 500) of the overall NIH grants funded from 2015 to 2023. DHT research funding increased during this period from $348 725 600 to $1 533 281 000. DHT research publications and clinical trials using the same search terms increased from 3714 to 14 786 and from 89 to 240, respectively. More DHT research funding was used for research and development purposes (59.3%) than for clinical or regulatory purposes (41.0%) based on manual, second-level data curation.

Conclusions and relevance: This study found that investments in DHT research at the NIH has increased over the past 9 years and that this increase has been steady since 2015, including during and even after the COVID-19 pandemic. Increased use of DHTs is expected to continue as these technologies become a more integral part of the biomedical research ecosystem.

Importance: The ability of surgeons to choose the right patient for fusion in addition to decompression when operating for degenerative spondylolisthesis with symptomatic spinal stenosis is debated. The addition of fusion increases risk, morbidity, and costs but has been claimed to give better results for selected patients.

Objective: To investigate whether following surgeons' opinions regarding fusion was associated with clinical outcomes.

Design, setting, and participants: This cohort study was conducted alongside the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis randomized clinical trial, which showed noninferiority for decompression alone compared with decompression with fusion. From February 12, 2014, to December 18, 2017, trial surgeons from 16 Norwegian departments denoted their preferred treatment for 222 of 267 patients with symptomatic spinal stenosis and degenerative spondylolisthesis. For this analysis, the clinical outcomes of the patients who were and were not randomized to the recommended treatment were compared.

Main outcome and measures: The primary outcome was a reduction of at least 30% from baseline to 2 years after surgery on the Oswestry Disability Index, ranging from 0 (no impairment) to 100 (maximum impairment). Secondary outcomes included the Zürich Claudication Questionnaire, leg and back pain scores, and the EuroQol 5-Dimension score.

Results: Among 222 patients (155 [70%] female; mean [SD] age, 66.2 [7.7] years), decompression alone was recommended for 112 patients, of whom 59 received only decompression, and additional fusion for 110 patients, of whom 57 received fusion. At 2-year follow-up, 87 of 116 patients (75%) who received surgery in agreement with the surgeons' recommendations and 77 of 106 (73%) who received surgery in disagreement with the surgeons' recommendations reached the primary outcome (difference, 2.4 percentage points; 95% CI, -9.1 to 13.9 percentage points). All secondary outcomes were in the same direction as the primary outcome.

Conclusions and relevance: In this cohort study of 222 patients with degenerative spondylolisthesis who participated in a randomized clinical trial, surgeons' recommendations were not associated with better outcomes than a random allocation when deciding between decompression alone and decompression with instrumented fusion. The results suggest that surgeons performing degenerative spondylolisthesis surgery could rely safely on evidence of operating with decompression alone, despite the conflict of expert opinion.

Importance: There is limited evidence regarding the association between age at menopause and incident type 2 diabetes (T2D).

Objective: To investigate whether age at menopause and premature menopause are associated with T2D incidence in postmenopausal Korean women.

Design, setting, and participants: This population-based cohort study was conducted among a nationally representative sample from the Korean National Health Insurance Service database of 1 125 378 postmenopausal women without T2D who enrolled in 2009. The median (IQR) follow-up was 8.4 (8.1-8.7) years. Data were analyzed in March 2024.

Exposures: Age at menopause and premature menopause (menopause onset at age <40 years).

Main outcomes and measures: The primary outcome was incident T2D. Multivariable Cox proportional hazards regression analysis was used to estimate hazard ratios (HRs) and 95% CIs for incident T2D by age at menopause, adjusting for potential confounders.

Results: Of 1 125 378 participants (mean [SD] age at enrollment, 61.2 [8.4] years), 113 864 individuals (10.1%) were diagnosed with T2D at least 1 year after enrollment. Women with menopause onset at ages younger than 40 years (premature menopause; HR, 1.13; 95% CI, 1.08-1.18) and ages 40 to 44 years (HR, 1.03; 95% CI, 1.00-1.06) had increased risk of T2D compared with those with onset at age 50 years or older, with adjustment for sociodemographic, lifestyle, cardiometabolic, psychiatric, and reproductive factors; a younger age at menopause was associated with increased risk of developing T2D (P for trend <.001). Body mass index, depressive disorder, and prediabetes modified the association in subgroup analyses; for example, for individuals with premature menopause vs those with menopause at ages 50 years or older, HRs were 1.54 (95% CI, 1.14-2.06) for a BMI less than 18.5 and 1.14 (95% CI, 1.00-1.30) for a BMI of 30 or greater (P < .001), 1.28 (95% CI, 1.12-1.45) for individuals with depression and 1.11 (95% CI, 1.07-1.16) for those without depression (P = .01), and 1.25 (95% CI, 1.18-1.33) for individuals who were not prediabetic and 1.04 (95% CI, 0.99-1.11) those who were prediabetic (P < .001).

Conclusions and relevance: In this study, premature and early menopause were associated with a higher risk of T2D, highlighting the need for targeted public health strategies aimed at preventing or delaying T2D among postmenopausal women.

Importance: Improving access to high-quality maternity care and reducing maternal morbidity and mortality are major policy priorities in the US. Previous research has primarily focused on access to general obstetric care rather than access to high-risk pregnancy care provided by maternal-fetal medicine subspecialists (MFMs).

Objective: To measure access to MFM services and determine patient factors associated with MFM service use, including MFM telemedicine.

Design, setting, and participants: This cohort study identified pregnancies in commercial health insurance claims from the Health Care Cost Institute from 2016 to 2021. More than 2.1 million pregnancies were included, where age at delivery was 18 years or greater and people were continuously enrolled for the duration of their pregnancy. The association of patient and pregnancy covariates with MFM involvement in care was analyzed using logistic regression; and rates of telemedicine for pregnancies in urban and rural areas were reported over time. Data were analyzed from June 2022 to March 2024.

Main outcomes and measures: Primary study outcomes included whether a pregnancy ever had a service from an MFM, the type of MFM services provided, and whether MFM care occurred via telemedicine.

Results: There were 2 169 026 pregnancies among 1 968 091 unique people (1 325 212 [61.2%] aged 25 to 34 years). Among 1 625 237 pregnancies at risk for conditions that might require MFM involvement, 838 493 (51.6%) had an MFM service. Rates of MFM involvement in care varied considerably by geography, with pregnancies in rural areas having lower use than urban areas. Use of telemedicine-enabled MFM care increased in 2020 and 2021 but remained low: in 2021, 2.7% of urban pregnancies (7535 of 276 599) and 1.7% of rural pregnancies (550 of 32 949) received telemedicine-enabled MFM care.

Conclusions and relevance: In this cohort study, access to MFM services varied across geography, even among pregnancies at risk for conditions that might require MFM involvement. These results suggested a need to improve access to MFM care for at-risk pregnancies and to further explore expanded access via telemedicine.

Importance: Environmental service workers (ESWs) have a critical role within the hospital infrastructure and are at the frontline of infection prevention. ESWs are highly trained in managing all forms of regulated waste, which includes biohazardous waste, and are responsible for the overall patient experience, janitorial work, and infection prevention. Without environmental services, patients have a 6 times greater risk of being infected by pathogens from patients who previously occupied their room.

Objective: To understand how ESWs felt proud, connected, and not connected to their hospital-based clinical teams.

Design, setting, and participants: This qualitative study included 10 ESWs who were members of clinical care teams at a medical university hospital in upstate New York. Data were collected from February to May 2024.

Main outcome and measures: Participants were asked to take pictures and write vignettes about what makes them feel proud of their work, how they feel connected to their clinical team, and how they feel disconnected from their clinical team.

Results: This study included 10 participants (5 males [50%]; 10 non-Hispanic Black or African American individuals [100%]; mean [range] age, 53 [38-66] years; 8 were high school graduates or had some college credit [80%]). When asked about their feeling of pride, participants expressed maintaining a clean space, having meaningful relationships, and helping others as generating a sense of pride. Participants' feelings of disconnectedness were felt by their colleagues not following the rules set in place. In addition, participants reported feeling invisible, not listened to, unappreciated, and undervalued. Participants felt connected to their clinical teams by feeling a sense of community, having valuable relationships, and being able to communicate with members of the clinical team. Additionally, participants expressed a collective desire to be acknowledged, recognized, and treated as equals on the clinical team.

Conclusions and relevance: The study found that ESWs identified feeling both connected to and disconnected from their clinical teams. Based on these results, hospital infrastructure and leadership should continue to exhaust all efforts to explore work experiences of ESWs to improve job retention, morale, satisfaction, overall clinical teamwork, and comradery.

Importance: Data characterizing the severity and changing prevalence of bone mineral density (BMD) deficits and associated nonfracture consequences among childhood cancer survivors decades after treatment are lacking.

Objective: To evaluate risk for moderate and severe BMD deficits in survivors and to identify long-term consequences of BMD deficits.

Design, setting, and participants: This cohort study used cross-sectional and longitudinal data from the St Jude Lifetime (SJLIFE) cohort, a retrospectively constructed cohort with prospective follow-up. Participants in SJLIFE are adult survivors of childhood cancer who were diagnosed between 1962 and 2012 and survived 5 years or more from diagnosis. Data were collected from November 2007 to June 2020 and analyzed from January 2021 to November 2023.

Exposures: Childhood cancer therapy exposures, clinically ascertained comorbid conditions, substance use, and sedentary lifestyle.

Main outcomes and measures: BMD was evaluated using lumbar quantitative computed tomography and classified by age- and sex-specific z scores with moderate (≤-1 SD) or severe (≤-2 SD) deficits. Multivariable logistic regression estimated odds ratios (ORs), attributable fractions (AFs), and associations between BMD deficits and long-term sequelae (social, functional, and quality of life [QOL]).

Results: Among 3919 five-year survivors (median [range] age, 31.7 [18.0-69.9] years; 2063 [52.6%] male; 105 [2.7%] Hispanic, 607 [15.5%] non-Hispanic Black, and 3153 [80.4%] non-Hispanic White), prevalence of moderate or severe BMD deficits were 21.7% (95% CI, 20.4%-23.0%) and 6.9% (95% CI, 6.1%-7.7%), respectively. Treatment exposures (including age at diagnosis), comorbid conditions, and smoking and sedentary behavior explained 18.5%, 10.2%, and 7.0% of moderate and 55.4%, 51.1%, and 9.9% of severe deficits. Severe deficits were associated with 30 Gy or greater cranial radiotherapy (CRT) (OR, 5.22; 95% CI, 3.74-7.30; AF, 33.0%), testicular or pelvic radiation (OR, 1.70, 95% CI, 1.19-2.44; AF, 11.5%), hypogonadism (OR, 3.27, 95% CI, 2.35-4.55; AF, 25.1%), growth hormone deficiency (OR, 5.28, 95% CI, 3.68-7.56; AF, 26.0%), smoking (OR, 1.71, 95% CI, 1.21-2.43; AF, 6.7%), and sedentary behavior (OR, 2.06, 95% CI, 1.15-3.69; AF, 6.2%). CRT exposure increased risk for declining BMD (OR, 2.94, 95% CI, 1.46-5.91; AF, 8.8%). Survivors with deficits were less likely to live alone and to be employed and more likely to require personal care assistance and to report depressive symptoms and poor QOL.

Conclusions and relevance: While treatment exposures were associated with long-term BMD deficits, modifiable risk factors, including smoking, sedentary behavior, hypogonadism, and growth hormone deficiency, suggest feasible targets for intervention.

Importance: Recently, the US Food and Drug Administration gave premarketing approval to an algorithm based on its purported ability to identify individuals at genetic risk for opioid use disorder (OUD). However, the clinical utility of the candidate genetic variants included in the algorithm has not been independently demonstrated.

Objective: To assess the utility of 15 genetic variants from an algorithm intended to predict OUD risk.

Design, setting, and participants: This case-control study examined the association of 15 candidate genetic variants with risk of OUD using electronic health record data from December 20, 1992, to September 30, 2022. Electronic health record data, including pharmacy records, were accrued from participants in the Million Veteran Program across the US with opioid exposure (n = 452 664). Cases with OUD were identified using International Classification of Diseases, Ninth Revision, or International Classification of Diseases, Tenth Revision, diagnostic codes, and controls were individuals with no OUD diagnosis.

Exposures: Number of risk alleles present across 15 candidate genetic variants.

Main outcome and measures: Performance of 15 genetic variants for identifying OUD risk assessed via logistic regression and machine learning models.

Results: A total of 452 664 individuals with opioid exposure (including 33 669 with OUD) had a mean (SD) age of 61.15 (13.37) years, and 90.46% were male; the sample was ancestrally diverse (with individuals of genetically inferred European, African, and admixed American ancestries). Using Nagelkerke R2, collectively, the 15 candidate genes accounted for 0.40% of variation in OUD risk. In comparison, age and sex alone accounted for 3.27% of the variation. The ensemble machine learning. The ensemble machine learning model using the 15 variants as predictive factors correctly classified 52.83% (95% CI, 52.07%-53.59%) of individuals in an independent testing sample.

Conclusions and relevance: Results of this study suggest that the candidate genetic variants included in the approved algorithm do not meet reasonable standards of efficacy in identifying OUD risk. Given the algorithm's limited predictive accuracy, its use in clinical care would lead to high rates of both false-positive and false-negative findings. More clinically useful models are needed to identify individuals at risk of developing OUD.