JAMA Network Open
Published by: American Medical Association (AMA)
Total articles ≅ 8,167
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JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6315
The hypoglycemia risk stratification tool1,2 was developed to identify patients with diabetes at high risk of emergency department (ED) visits or hospitalizations due to hypoglycemia using electronic health records only. The 12-month rate of hypoglycemia-related ED visits or hospitalizations among patients at high risk was 6.7%, vs 0.3% for those at low or intermediate risk (C statistic = 0.83).1 This tool also performed well in 2 external validations among 1 350 938 patients with diabetes (C statistic = 0.79 and 0.81).1 Kaiser Permanente Northern California (KPNC) uses this tool to identify patients at high risk (those with ≥3 hypoglycemia-related ED visits or hospitalizations and insulin users with any history of hypoglycemia-related ED visits or hospitalizations). The tool is available as a free online calculator.3 To our knowledge, this tool has not been validated against biochemical hypoglycemia based on continuous glucose monitor (CGM) data.
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6324
In recent years, the concept of the tumor immune microenvironment, with the presence of tumor cells and infiltrating immune cells, has been intensively studied. Of particular interest are the complex interactions between tumor and immune cells that are involved in the dynamic balance between tumor control and progression.1-5 Several studies6-8 have reported the potential prognostic relevance of tumor-infiltrating T lymphocytes in various types of cancer, including studies conducted in patients with head and neck cancers. Specifically, head and neck squamous cell carcinoma (HNSCC) is considered a tumor with high immunogenic potential.5,9
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.4149
Importance: Disulfiram has demonstrated broad antitumoral effect in several preclinical studies. One of the proposed indications is for the treatment of glioblastoma.Objective: To evaluate the efficacy and safety of disulfiram and copper as add-on to alkylating chemotherapy in patients with recurrent glioblastoma.Design, Setting, and Participants: This was a multicenter, open-label, randomized phase II/III clinical trial with parallel group design. Patients were recruited at 7 study sites in Sweden and 2 sites in Norway between January 2017 and November 2020. Eligible patients were 18 years or older, had a first recurrence of glioblastoma, and indication for treatment with alkylating chemotherapy. Patients were followed up until death or a maximum of 24 months. The date of final follow-up was January 15, 2021. Data analysis was performed from February to September 2022.Interventions: Patients were randomized 1:1 to receive either standard-of-care (SOC) alkylating chemotherapy alone, or SOC with the addition of disulfiram (400 mg daily) and copper (2.5 mg daily).Main Outcomes and Measures: The primary end point was survival at 6 months. Secondary end points included overall survival, progression-free survival, adverse events, and patient-reported quality of life.Results: Among the 88 patients randomized to either SOC (n = 45) or SOC plus disulfiram and copper (n = 43), 63 (72%) were male; the mean (SD) age was 55.4 (11.5) years. There was no significant difference between the study groups (SOC vs SOC plus disulfiram and copper) in 6 months survival (62% [26 of 42] vs 44% [19 of 43]; P = .10). Median overall survival was 8.2 months (95% CI, 5.4-10.2 months) with SOC and 5.5 months (95% CI, 3.9-9.3 months) with SOC plus disulfiram and copper, and median progression-free survival was 2.6 months (95% CI, 2.4-4.6 months) vs 2.3 months (95% CI, 1.7-2.6 months), respectively. More patients in the SOC plus disulfiram and copper group had adverse events grade 3 or higher (34% [14 of 41] vs 11% [5 of 44]; P = .02) and serious adverse events (41% [17 of 41] vs 16% [7 of 44]; P = .02), and 10 patients (24%) discontinued disulfiram treatment because of adverse effects.Conclusions and Relevance: This randomized clinical trial found that among patients with recurrent glioblastoma, the addition of disulfiram and copper to chemotherapy, compared with chemotherapy alone, resulted in significantly increased toxic effects, but no significant difference in survival. These findings suggest that disulfiram and copper is without benefit in patients with recurrent glioblastoma.Trial Registration: ClinicalTrials.gov Identifier: NCT02678975; EUDRACT Identifier: 2016-000167-16
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6178
Importance: It is challenging to ensure timely performance of radiologist-recommended additional imaging when radiologist recommendation language is incomplete or ambiguous.Objective: To evaluate whether voluntary use of an information technology tool with forced structured entry of recommendation attributes was associated with improved completeness of recommendations for additional imaging over time.Design, Setting, and Participants: This cohort study of imaging report data was performed at an academic quaternary care center in Boston, Massachusetts, and included consecutive adults with radiology examinations performed from September 12 to 13, 2019 (taxonomy validation), October 14 to 17, 2019 (before intervention), April 5 to 7, 2021 (1 week after intervention), and April 4 to 7, 2022 (1 year after intervention), with reports containing recommendations for additional imaging. A radiologist scored the 3 groups (preintervention group, 1-week postintervention group, and 1-year postintervention group) of 336 consecutive radiology reports (n = 1008) with recommendations for additional imaging.Intervention: Final implementation on March 27, 2021, of a voluntary closed-loop communication tool embedded in radiologist clinical workflow that required structured entry of recommendation attributes.Main Outcomes and Measures: The a priori primary outcome was completeness of recommendations for additional imaging, defined in a taxonomy created by a multidisciplinary expert panel. To validate the taxonomy, 2 radiologists independently reviewed and scored language attributes as present or absent in 247 consecutive radiology reports containing recommendations for additional imaging. Agreement was assessed with Cohen κ. Recommendation completeness over time was compared with with 1-sided Fisher exact tests and significance set at P < .05.Results: Radiology-related information for consecutive radiology reports from the 4 time periods was collected from the radiology department data warehouse, which does not include data on patient demographic characteristics or other nonimaging patient medical information. The panel defined 5 recommendation language attributes: complete (contains imaging modality, time frame, and rationale), ambiguous (equivocal, vague language), conditional (qualifying language), multiplicity (multiple options), and alternate (language favoring a different examination to that ordered). Two radiologists had more than 90% agreement (κ > 0.8) for these attributes. Completeness with use of the tool increased more than 3-fold, from 14% (46 of 336) before the intervention to 46% (153 of 336) (P < .001) 1 year after intervention; completeness in the corresponding free-text report language increased from 14% (46 of 336) before the intervention to 25% (85 of 336) (P < .001) 1 year after the intervention.Conclusions and Relevance: This study suggests that supplementing free-text dictation with voluntary use of a structured entry tool was associated with improved completeness of radiologist recommendations for additional imaging as assessed by an internally validated taxonomy. Future research is needed to assess the association with timely performance of clinically necessary recommendations and diagnostic errors. The taxonomy can be used to evaluate and build interventions to modify radiologist reporting behaviors.
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6286
As a field, much is known about behavioral sleep intervention (BSI) in infants. Infant BSI is an umbrella term for behaviorally based interventions that promote
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6318
Hernia surgery is commonly performed with a low rate of postoperative adverse events (AEs). Risk of complications (eg, infection, bleeding, and superficial wound dehiscence) is higher for patients with type 1 or 2 diabetes,1 and several academic societies recommend testing glycemic control preoperatively, including the American Diabetes Association,2 the Society for Ambulatory Anesthesia,3 and the Endocrine Society.4 However, there is limited evidence that keeping within recommended blood glucose (BG) concentrations of 100 to 180 mg/dL (to convert to millimoles per liter, multiply by 0.0555) is associated with improved outcomes in ambulatory surgery. Our objective was to test the hypothesis that poor same-day preoperative glycemic control was associated with higher odds of postoperative AEs among Veterans Health Administration (VHA) patients with diabetes undergoing ambulatory hernia surgery.
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6173
The US has high infant mortality rates, ranking 34 of 38 among Organisation for Economic Co-operation and Development nations in 2019.1 Infant mortality is most commonly associated with preterm birth and low birth weight,2 with earlier preterm and lower weight newborns having higher risk of death.3-5 Rates of infant mortality have substantial disparities by race and socioeconomic status, with Black and low-income people most likely to have adverse birth outcomes.6-9 These disparities are associated with both individual-level socioeconomic factors and structural determinants of health that function at a neighborhood and societal level.8,10-15 A recent consensus statement on racial disparities on preterm birth highlighted stress and neighborhood disadvantage as likely factors.10
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6185
Importance: A previous meta-analysis of the association between alcohol use and all-cause mortality found no statistically significant reductions in mortality risk at low levels of consumption compared with lifetime nondrinkers. However, the risk estimates may have been affected by the number and quality of studies then available, especially those for women and younger cohorts.Objective: To investigate the association between alcohol use and all-cause mortality, and how sources of bias may change results.Data Sources: A systematic search of PubMed and Web of Science was performed to identify studies published between January 1980 and July 2021.Study Selection: Cohort studies were identified by systematic review to facilitate comparisons of studies with and without some degree of controls for biases affecting distinctions between abstainers and drinkers. The review identified 107 studies of alcohol use and all-cause mortality published from 1980 to July 2021.Data Extraction and Synthesis: Mixed linear regression models were used to model relative risks, first pooled for all studies and then stratified by cohort median age (<56 vs ≥56 years) and sex (male vs female). Data were analyzed from September 2021 to August 2022.Main Outcomes and Measures: Relative risk estimates for the association between mean daily alcohol intake and all-cause mortality.Results: There were 724 risk estimates of all-cause mortality due to alcohol intake from the 107 cohort studies (4 838 825 participants and 425 564 deaths available) for the analysis. In models adjusting for potential confounding effects of sampling variation, former drinker bias, and other prespecified study-level quality criteria, the meta-analysis of all 107 included studies found no significantly reduced risk of all-cause mortality among occasional (>0 to <1.3 g of ethanol per day; relative risk [RR], 0.96; 95% CI, 0.86-1.06; P = .41) or low-volume drinkers (1.3-24.0 g per day; RR, 0.93; P = .07) compared with lifetime nondrinkers. In the fully adjusted model, there was a nonsignificantly increased risk of all-cause mortality among drinkers who drank 25 to 44 g per day (RR, 1.05; P = .28) and significantly increased risk for drinkers who drank 45 to 64 and 65 or more grams per day (RR, 1.19 and 1.35; P < .001). There were significantly larger risks of mortality among female drinkers compared with female lifetime nondrinkers (RR, 1.22; P = .03).Conclusions and Relevance: In this updated systematic review and meta-analysis, daily low or moderate alcohol intake was not significantly associated with all-cause mortality risk, while increased risk was evident at higher consumption levels, starting at lower levels for women than men.
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.6276
Black individuals in the US experience disparities in sleep throughout their lifespan.1-3 During infancy, Black infants have shorter sleep durations than White infants and are less likely to meet recommended guidelines of at least 12 hours of sleep per day.4-6 These patterns are concerning, given links between infants’ sleep and later outcomes, including child overweight and obesity,7,8 social-emotional functioning,9,10 and cognitive development.11,12 Behavioral interventions for parents can improve infants’ sleep by encouraging the use of recommended parenting practices, such as consistent bedtime routines and developmentally appropriate responses to night wakings.13-18 These interventions are seen as a promising approach to reducing sleep and sleep-related health disparities early in development.19,20 To date, however, implementation of these interventions among racially and ethnically diverse populations has been limited.21 To our knowledge, only 1 intervention study has specifically aimed to promote better sleep among Black infants,22 and results from that study indicated no significant differences between the intervention and control groups in maternal reports of infant sleep problems or infant nighttime awakenings over the first 15 months post partum.23 As such, there is a need to identify behavioral interventions that improve infant sleep among Black families.
JAMA Network Open, Volume 6; https://doi.org/10.1001/jamanetworkopen.2023.1198
Widespread diffusion of minimally invasive technologies and advances in perioperative care have substantially reduced the length of time that patients spend in the hospital recovering from surgery. In the current climate of value-based care, surgical procedures are increasingly performed in an outpatient setting. The adoption of outpatient surgery has been pervasive across surgical subspecialties, with studies describing the feasibility and safety of outpatient procedures such as colectomy,1,2 inguinal hernia repair,3 and adrenalectomy.4 Benefits of same-day discharge include a reduced risk of exposure to nosocomial infections, cost savings due to reduced use of resources, and increased patient satisfaction due to the ability to convalesce in familiar surroundings.5