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Importance: Few studies are available on informed consent (IC) among detained persons, even with ethics being a critical aspect of prison research. In IC research, audiovisual material seems to improve understanding and satisfaction compared with conventional paper-based material, but findings remain unclear., Objective: To compare audiovisual and paper-based materials for 1-time general IC for research in prisons., Design, Setting, and Participants: This cross-sectional randomized clinical trial was conducted in 2 corrections facilities in Switzerland (an adult prison and a juvenile detention center). The study was conducted from December 14, 2019, to December 2, 2020, in the adult prison and from January 15, 2020, to September 9, 2021, in the juvenile detention center. In the adult prison, study participation was offered to detained persons visiting the medical unit (response rate, 84.7%). In the juvenile detention center, all newly incarcerated adolescents were invited to participate (response rate, 98.0%)., Interventions: Participants were randomized to receive paper-based conventional material or to watch a 4-minute video. Materials included the same legal information, as required by the Swiss Federal Act on Research Involving Human Beings., Main Outcomes and Measures: The main outcome was acceptance to sign the IC form. Secondary outcomes included understanding, evaluation, and time to read or watch the IC material., Results: The study included 190 adults (mean [SD] age, 35.0 [11.8] years; 190 [100%] male) and 100 adolescents (mean [SD] age, 16.0 [1.1] years; 83 [83.0%] male). In the adult prison, no significant differences were found between groups in acceptance to sign the IC form (77 [81.1%] for paper-based material and 81 [85.3%] for audiovisual material; P = .39) and to evaluate it (mean [SD] correct responses, 5.09 [1.13] for paper-based material and 5.01 [1.07] for audiovisual material; P = .81). Understanding was significantly higher in the audiovisual material group (mean [SD] correct responses, 5.09 [1.84]) compared with the paper-based material group (mean [SD] correct responses, 4.61 [1.70]; P = .04). In the juvenile detention center, individuals in the audiovisual material group were more likely to sign the IC form (44 [89.8%]) than the paper-based material group (35 [68.6%], P = .006). No significant difference was found between groups for understanding and evaluation. Adults took a mean (SD) of 5 (2) minutes to read the paper material, and adolescents took 7 (3) minutes., Conclusions and Relevance: Given the small benefit of audiovisual material, these findings suggest that giving detained adults and prison health care staff a choice regarding IC material is best. For adolescents, audiovisual material should be provided. Future studies should focus on increasing understanding of the IC process., Trial Registration: ClinicalTrials.gov Identifier: NCT05505058.

Importance: The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients., Objective: To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement., Design, Setting, and Participants: This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019., Exposures: Respondents read and returned the aforementioned paper survey, while nonrespondents did not., Main Outcomes and Measures: The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups., Results: Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold., Conclusions and Relevance: In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

Importance: Mass violence incidents (MVIs) are prevalent in the US and can have profound and long-lasting psychological consequences on direct survivors, but their outcomes among the broader communities where the MVI occurred are unknown., Objective: To investigate the prevalence of and factors associated with past-year and current posttraumatic stress disorder (PTSD) among adults in communities that experienced an MVI., Design, Setting, and Participants: This cross-sectional survey was completed between February and September 2020 with a household probability sample of adults from 6 communities that had experienced an MVI between 2015 and 2019: Dayton, Ohio; El Paso, Texas; Parkland, Florida; Pittsburgh, Pennsylvania; San Bernadino, California; and Virginia Beach, Virginia. Address-based sampling was used to identify randomly selected households, mail invitations, and select 1 adult per household to complete a self-administered paper or online survey. Data analysis was performed from September to November 2023., Main Outcomes and Measures: The primary outcome was presumptive diagnostic-level past-year PTSD and current (past month) PTSD determined using American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) PTSD criteria., Results: A total of 6867 adults aged 18 years or older accessed the website with a description of the study and consent materials. Of these, 5991 (87.2%) agreed to participate and completed the survey, 343 (6.3%) partially completed the survey, and 443 (6.5%) did not meet eligibility criteria or refused to participate. Most of the 5991 respondents were female (3825 individuals [53.5%]) and had a mean (SD) age of 45.56 (17.58) years. A total of 1261 of 5931 individuals (21.0%) reported high exposure to the MVI (either they or a close friend and/or family member was on site during the shooting). Nearly one-quarter (23.7%; 1417 of 5977 participants reporting PTSD) met presumptive DSM-5 diagnostic criteria for past-year PTSD, with 8.9% (530 participants) meeting the criteria for current PTSD. Regression analyses found that being female (odds ratio, 2.32; 95% CI, 2.01-2.68) and having a history of both physical or sexual assault and other potentially traumatic events (odds ratio, 9.68; 95% CI, 7.48-12.52) were associated with the greatest risk of past-year PTSD., Conclusions and Relevance: In this survey study of 5991 participants, presumptive PTSD was quite prevalent long after the MVI among adults in communities that have experienced an MVI, suggesting that MVIs have persistent and pervasive public health impacts on communities, particularly among those with prior exposure to physical or sexual assault and other potentially traumatic events. Focusing exclusively on direct exposure to MVIs is not sufficient. Incorporating these findings into screening should improve efforts to identify the individuals most in need of prevention or mental health service after MVIs.

Importance: The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship., Objective: To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy., Design, Setting, and Participants: This prospective, longitudinal cohort study was conducted between May 2018 and July 2020, with time points over 12 months. Participants included patients at National Cance Institute Community Oncology Research Program sites. Eligibility criteria included age at least 18 years, newly diagnosed stage I to III CRC, not started chemotherapy and/or radiation, treated with curative intent, and able to speak English. Data were analyzed from December 2022 through April 2023., Main Outcomes and Measures: The primary end point was financial hardship, measured using the Comprehensive Score for Financial Toxicity (COST), which assesses the psychological domain of financial hardship (range, 0-44; higher score indicates better financial well-being). Participants completed 30-minute surveys (online or paper) at baseline and 3, 6, and 12 months., Results: A total of 450 participants (mean [SD] age, 61.0 [12.0] years; 240 [53.3%] male) completed the baseline survey; 33 participants (7.3%) were Black and 379 participants (84.2%) were White, and 14 participants (3.1%) identified as Hispanic or Latino and 424 participants (94.2%) identified as neither Hispanic nor Latino. There were 192 participants (42.7%) with an annual household income of $60 000 or greater. There was an improvement in financial hardship from diagnosis to 12 months of 0.3 (95% CI, 0.2 to 0.3) points per month (P < .001). Patients with better quality of life and greater self-efficacy had less financial toxicity. Each 1-unit increase in Functional Assessment of Cancer Therapy-General (rapid version) score was associated with an increase of 0.7 (95% CI, 0.5 to 0.9) points in COST score (P < .001); each 1-unit increase in self-efficacy associated with an increase of 0.6 (95% CI, 0.2 to 1.0) points in COST score (P = .006). Patients who lived in areas with lower neighborhood socioeconomic status had greater financial toxicity. Neighborhood deprivation index was associated with a decrease of 0.3 (95% CI, -0.5 to -0.1) points in COST score (P = .009)., Conclusions and Relevance: These findings suggest that interventions for financial toxicity in cancer care should focus on counseling to improve self-efficacy and mitigate financial worry and screening for these interventions should include patients at higher risk of financial burden.

Importance: Since the onset of the COVID-19 outbreak, an extremely high number of studies have been published worldwide, with variable quality. Research trends of highly cited papers may enable identification of influential research, providing insights for new research ideas; it is therefore important to investigate trends and focus on more influential publications in COVID-19-related studies., Objective: To examine research trends of highly cited studies by conducting a bibliometric analysis of highly cited studies in the previous 2 months about COVID-19., Design, Setting, and Participants: In this cross-sectional study, Essential Science Indicators (ESI) and Web of Science (WOS) Core Collection were used to find studies with a focus on COVID-19 that were identified as highly cited studies from Clarivate Analytics. Highly cited studies were extracted from the ESI database bimonthly between January 2020 and December 2022. Bibliographic details were extracted from WOS and combined with ESI data using unique accession numbers. The number of highly cited studies was counted based on the fractional counting method. Data were analyzed from January through July 2023., Main Outcomes and Measures: The number of publications by research field, country, and institutional affiliation., Results: The number of published COVID-19-related highly cited studies was 14 studies in January to February 2020, peaked at 1292 studies in November to December 2021, and showed a downward trend thereafter, reaching 649 studies in November to December 2022. China had the highest number of highly cited studies per 2-month period until July to August 2020 (138.3 studies vs 103.7 studies for the US, the second highest country), and the US had the greatest number of highly cited studies afterward (159.9 studies vs 157.6 studies for China in September to October 2020). Subsequently, the number of highly cited studies per 2-month period published by China declined (decreasing from 179.7 studies in November to December 2020 to 40.7 studies in September to October 2022), and the UK produced the second largest number of such studies in May to June 2021 (171.3 studies). Similarly, the top 5 institutional affiliations in May to June 2020 by highly cited studies per 2-month period were from China (Huazhong University: 14.7 studies; University of Hong Kong: 6.8 studies; Wuhan University: 4.8 studies; Zhejiang University: 4.5 studies; Fudan University: 4.5 studies), while in November to December 2022, the top 5 institutions were in the US and UK (Harvard University: 15.0 studies; University College London: 11.0 studies; University of Oxford: 10.2 studies; University of London: 9.9 studies; Imperial College London: 5.8 studies)., Conclusions and Relevance: This study found that the total number of highly cited studies related to COVID-19 peaked at the end of 2021 and showed a downward trend until the end of 2022, while the origin of these studies shifted from China to the US and UK.

Importance: Deviations from international resuscitation guidelines during the management of pediatric cardiac arrest are frequent and affect clinical outcomes. An interactive tablet application (app), PediAppRREST, was developed to reduce guideline deviations during pediatric cardiac arrest., Objective: To assess the effectiveness of PediAppRREST in improving the management of simulated in-hospital pediatric cardiac arrest., Design, Setting, and Participants: This multicenter 3-group simulation-based randomized clinical trial was conducted from September 2020 to December 2021 at 4 Italian university hospitals (Padua, Florence, Rome, Novara). Participants included residents in pediatrics, emergency medicine, and anesthesiology. Analyses were conducted as intention-to-treat. Data were analyzed from January to June 2022., Interventions: Teams were randomized to 1 of 3 study groups: an intervention group that used the PediAppRREST app; a control group that used a paper-based cognitive aid, the Pediatric Advanced Life Support (PALS) pocket card; and a control group that used no cognitive aids. All the teams managed the same standardized simulated scenario of nonshockable pediatric cardiac arrest., Main Outcomes and Measures: The primary outcome was the number of deviations from guidelines, measured by a 15-item checklist based on guideline recommendations. The main secondary outcomes were quality of chest compressions, team clinical performance (measured by the Clinical Performance Tool), and perceived team leader's workload. Study outcomes were assessed via video reviews of the scenarios., Results: Overall 100 teams of 300 participants (mean [SD] age, 29.0 [2.2] years; 195 [65%] female) were analyzed by intention-to-treat, including 32 teams randomized to the PediAppRREST group, 35 teams randomized to the PALS control group, and 33 teams randomized to the null control group. Participant characteristics (210 pediatric residents [70%]; 48 anesthesiology residents [16%]; 42 emergency medicine residents [14%]) were not statistically different among the study groups. The number of deviations from guidelines was significantly lower in the PediAppRREST group than in the control groups (mean difference vs PALS control, -3.0; 95% CI, -4.0 to -1.9; P < .001; mean difference vs null control, -2.6; 95% CI, -3.6 to -1.5; P < .001). Clinical Performance Tool scores were significantly higher in the PediAppRREST group than control groups (mean difference vs PALS control, 1.4; 95% CI, 0.4 to 2.3; P = .002; mean difference vs null control, 1.1; 95% CI, 0.2 to 2.1; P = .01). The other secondary outcomes did not significantly differ among the study groups., Conclusions and Relevance: In this randomized clinical trial, the use of the PediAppRREST app resulted in fewer deviations from guidelines and a better team clinical performance during the management of pediatric cardiac arrest., Trial Registration: ClinicalTrials.gov Identifier: NCT04619498.

Importance: SARS-CoV-2 infection has been associated with more severe disease and death in patients with cancer. However, the implications of certain tumor types, treatments, and the age and sex of patients with cancer for the outcomes of COVID-19 remain unclear., Objective: To assess the differences in clinical outcomes between patients with cancer and SARS-CoV-2 infection and patients without cancer but with SARS-CoV-2 infection, and to identify patients with cancer at particularly high risk for a poor outcome., Data Sources: PubMed, Web of Science, and Scopus databases were searched for articles published in English until June 14, 2021. References in these articles were reviewed for additional studies., Study Selection: All case-control or cohort studies were included that involved 10 or more patients with malignant disease and SARS-CoV-2 infection with or without a control group (defined as patients without cancer but with SARS-CoV-2 infection). Studies were excluded if they involved fewer than 10 patients, were conference papers or abstracts, were preprint reports, had no full text, or had data that could not be obtained from the corresponding author., Data Extraction and Synthesis: Two investigators independently performed data extraction using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Meta-analysis was performed using a random-effects model., Main Outcomes and Measures: The difference in mortality between patients with cancer and SARS-CoV-2 infection and control patients as well as the difference in outcomes for various tumor types and cancer treatments. Pooled case fatality rates, a random-effects model, and random-effects meta-regressions were used., Results: A total of 81 studies were included, involving 61 532 patients with cancer. Among 58 849 patients with available data, 30 557 male individuals (52%) were included and median age ranged from 35 to 74 years. The relative risk (RR) of mortality from COVID-19 among patients with vs without cancer when age and sex were matched was 1.69 (95% CI, 1.46-1.95; P < .001; I2 = 51.0%). The RR of mortality in patients with cancer vs control patients was associated with decreasing age (exp [b], 0.96; 95% CI, 0.92-0.99; P = .03). Compared with other cancers, lung cancer (RR, 1.68; 95% CI, 1.45-1.94; P < .001; I2 = 32.9%), and hematologic cancer (RR, 1.42; 95% CI, 1.31-1.54; P < .001; I2 = 6.8%) were associated with a higher risk of death. Although a higher point estimate was found for genitourinary cancer (RR, 1.11; 95% CI, 1.00-1.24; P = .06; I2 = 21.5%), the finding was not statistically significant. Breast cancer (RR, 0.51; 95% CI, 0.36-0.71; P < .001; I2 = 86.2%) and gynecological cancer (RR, 0.76; 95% CI, 0.62-0.93; P = .009; I2 = 0%) were associated with a lower risk of death. Chemotherapy was associated with the highest overall pooled case fatality rate of 30% (95% CI, 25%-36%; I2 = 86.97%; range, 10%-100%), and endocrine therapy was associated with the lowest at 11% (95% CI, 6%-16%; I2 = 70.68%; range, 0%-27%)., Conclusions and Relevance: Results of this study suggest that patients with cancer and SARS-CoV-2 infection had a higher risk of death than patients without cancer. Younger age, lung cancer, and hematologic cancer were also risk factors associated with poor outcomes from COVID-19.

Importance: The cardiovascular outcome in selected populations when sodium-glucose cotransporter 2 inhibitors (SGLT2-Is) are emerging as standard therapy is not clearly understood. It is important to learn the magnitude of cardiovascular benefit using SGLT2-Is across the select subgroups that include both sexes and multiple age and racial and ethnic groups., Objectives: To evaluate the association between use of SGLT2-Is and cardiovascular benefits in a prespecified group in a larger sample size using data obtained from randomized clinical trials., Data Sources: Search of electronic databases PubMed, Google Scholar, Web of Science, and Cochrane from inception to January 10, 2021, with additional studies identified through conference papers and meeting presentations, ClinicalTrials.gov, and reference lists of published studies., Study Selection: Placebo-controlled randomized clinical trials in which participants had atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD, diabetes, or heart failure and which reported the primary outcome were included in this study. Multicenter observational and nonobservational studies and those with different outcomes of interest were excluded., Data Extraction and Synthesis: Medical Subject Heading search terms included SGLT2-I and multiple cardiovascular outcomes in different combinations. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. The analysis of all outcomes was performed using a Mantel-Haenszel equation and the random-effects model., Main Outcomes and Measures: Six efficacy outcomes of SGLT2-I use (cardiovascular death and hospitalization for heart failure [HHF] as the primary outcome and major adverse cardiovascular event, HHF, cardiovascular death, acute myocardial infarction, and all-cause mortality as secondary outcomes), were evaluated. Subgroup analysis was performed for the primary outcome of cardiovascular death or HHF. Odds ratios (ORs) and 95% CIs were used to compare 2 interventions., Results: Ten studies with 71 553 participants were included, among whom 39 053 received SGLT2-Is; among studies that reported these data, 28 809 were men and 15 655 were women (mean age, 65.2 [range, 61.9-70.0] years). Race and ethnicity were defined in the original trials and were categorized as Asian, Black, or other (6900 participants) and White (26 646 participants) for the purposes of this analysis (the category "other" was not specified consistently). In terms of age, 16 793 were younger than 65 years and 17 087 were 65 years or older. At a mean follow-up 2.3 (range, 0.8-4.2) years, the SGLT2-I group favored reduction in primary outcome (3165 of 39 053 [8.10%] vs 3756 of 32 500 [11.56%]; OR, 0.67 [95% CI, 0.55-0.80]; P < .001). No difference was noted in the rate of acute myocardial infarction compared with the placebo group (1256 of 26 931 [4.66%] vs 958 of 20 373 [4.70%]; OR, 0.95 [95% CI, 0.87-1.03]; P = .22). Subgroup analysis favored SGLT2-I use for the primary outcome in both sexes, age groups, and racial and ethnic groups., Conclusions and Relevance: This meta-analysis supports that SGLT2-Is have emerged as an effective class of drugs for improving cardiovascular morbidity and mortality in selected patients. Sodium-glucose cotransporter 2 inhibitors were not associated with reduced risk of acute myocardial infarction. Future long-term prospective studies are warranted to understand the long-term cardiovascular benefits.

Importance: Thousands of pregnant people with opioid use disorder (OUD) enter US jails annually, yet their access to medications for OUD (MOUD) that meet the standard of care (methadone and/or buprenorphine) is unknown., Objective: To assess the availability of MOUD for the treatment of pregnant individuals with OUD in US jails., Design, Setting, and Participants: In this cross-sectional study, electronic and paper surveys were sent to all 2885 identifiable US jails verified in the National Jails Compendium between August 19 and November 7, 2019. Respondents were medical and custody leaders within the jails., Main Outcomes and Measures: The primary outcome was the availability of MOUD (methadone and/or buprenorphine) for the treatment of pregnant people with OUD in US jails. Availability of MOUD was assessed based on (1) continuation of MOUD for pregnant incarcerated individuals (if the individual was receiving MOUD before incarceration), with or without initiation of MOUD; (2) both initiation and continuation of MOUD for pregnant individuals; (3) only continuation of MOUD for pregnant individuals; and (4) management of opioid withdrawal for pregnant individuals. Secondary outcomes included MOUD availability during the postpartum period and logistical factors associated with the provision of MOUD. Multivariate logistic regression analysis was used to assess factors associated with MOUD availability during pregnancy., Results: Among 2885 total surveys sent, 1139 (39.5%) were returned; of those, 836 surveys (73.4%; 29.0% of all surveys sent) could be analyzed, with similar proportions from metropolitan (399 jails [47.7%]) and rural (381 jails [45.6%]) settings. Overall, 504 jails (60.3%) reported that MOUD was available for medication continuation, with or without medication initiation, during pregnancy. Of those, 267 jails (53.0%; 31.9% of surveys included in the analysis) both initiated and continued MOUD, and 237 jails (47.0%; 28.3% of surveys included in the analysis) only continued MOUD; 190 of 577 jails (32.9%; 22.7% of surveys included in the analysis) reported opioid withdrawal as the only management for pregnant people with OUD. Among the 504 medication-providing jails, only 120 (23.8%) continued to provide MOUD during the postpartum period. Methadone was more commonly available at jails that only continued MOUD (84 of 123 jails [68.3%]), whereas buprenorphine was more commonly available at jails that both initiated and continued MOUD (73 of 119 jails [61.3%]). In an adjusted model, jails with higher odds of MOUD availability were located in the Northeast (odds ratio [OR], 10.72; 95% CI, 2.43-47.36) or metropolitan areas (OR, 1.92; 95% CI, 1.31-2.83), had private health care contracts (OR, 1.49; 95% CI, 1.03-2.14) and a higher number of women (≥70) reported in the female census (OR, 1.69; 95% CI, 1.02-2.80), and provided pregnancy testing within 2 weeks of arrival at the jail (OR, 2.66; 95% CI, 1.69-4.17)., Conclusions and Relevance: In this cross-sectional study, a substantial proportion of US jails did not provide access to MOUD to pregnant people with OUD. Although most jails reported continuing to provide MOUD to individuals who were receiving medication before incarceration, few jails initiated MOUD, and most medication-providing jails discontinued MOUD during the postpartum period. These results suggest that many pregnant and postpartum people with OUD in US jails do not receive medication that is the standard of care and are required to endure opioid withdrawal, signaling an opportunity for intervention to improve care for pregnant people who are incarcerated.

Importance: Geographic targeting of public health interventions is needed in resource-constrained developing countries., Objective: To develop methods for estimating health and development indicators across micropolicy units, using assembly constituencies (ACs) in India as an example., Design, Setting, and Participants: This cross-sectional study included children younger than 5 years who participated in the fourth National Family and Health Survey (NFHS-4), conducted between January 2015 and December 2016. Participants lived in 36 states and union territories and 640 districts in India. Children who had valid weight and height measures were selected for stunting, underweight, and wasting analysis, and children between age 6 and 59 months with valid blood hemoglobin concentration levels were included in the anemia analysis sample. The analysis was performed between February 1 and August 15, 2020., Exposures: A total of 3940 ACs were identified from the geographic location of primary sampling units in which the children's households were surveyed in NFHS-4., Main Outcomes and Measures: Stunting, underweight, and wasting were defined according to the World Health Organization Child Growth Standards. Anemia was defined as blood hemoglobin concentration less than 11.0 g/dL., Results: The main analytic sample included 222 172 children (mean [SD] age, 30.03 [17.01] months; 114 902 [51.72%] boys) from 3940 ACs in the stunting, underweight, and wasting analysis and 215 593 children (mean [SD] age, 32.63 [15.47] months; 112 259 [52.07%] boys) from 3941 ACs in the anemia analysis. The burden of child undernutrition varied substantially across ACs: from 18.02% to 60.94% for stunting, with a median (IQR) of 35.56% (29.82%-42.42%); from 10.40% to 63.24% for underweight, with a median (IQR) of 32.82% (25.50%-40.96%); from 5.56% to 39.91% for wasting, with a median (IQR) of 19.91% (15.70%-24.27%); and from 18.63% to 83.05% for anemia, with a median (IQR) of 55.74% (48.41%-63.01%). The degree of inequality within states varied across states; those with high stunting, underweight, and wasting prevalence tended to have high levels of inequality. For example, Uttar Pradesh, Jharkhand, and Karnataka had high mean AC-level prevalence of child stunting (Uttar Pradesh, 45.29%; Jharkhand, 43.76%; Karnataka, 39.77%) and also large SDs (Uttar Pradesh, 6.90; Jharkhand, 6.02; Karnataka, 6.72). The Moran I indices ranged from 0.25 to 0.80, indicating varying levels of spatial autocorrelation in child undernutrition across the states in India. No substantial difference in AC-level child undernutrition prevalence was found after adjusting for possible random displacement of geographic location data., Conclusions and Relevance: In this cross-sectional study, substantial inequality in child undernutrition was found across ACs in India, suggesting the importance of considering local electoral units in designing targeted interventions. The methods presented in this paper can be further applied to measuring health and development indicators in small electoral units for enhanced geographic precision of public health data in developing countries.

Importance: Knowing the expected effect of treatment on an individual patient is essential for patient care., Objective: To explore clinicians' conceptualizations of the chance that treatments will decrease the risk of disease outcomes., Design, Setting, and Participants: This survey study of attending and resident physicians, nurse practitioners, and physician assistants was conducted in outpatient clinical settings in 8 US states from June 2018 to November 2019. The survey was an in-person, paper, 26-item survey in which clinicians were asked to estimate the probability of adverse disease outcomes and expected effects of therapies for diseases common in primary care., Main Outcomes and Measures: Estimated chance that treatments would benefit an individual patient., Results: Of 723 clinicians, 585 (81%) responded, and 542 completed all the questions necessary for analysis, with a median (interquartile range [IQR]) age of 32 (29-44) years, 287 (53%) women, and 294 (54%) White participants. Clinicians consistently overestimated the chance that treatments would benefit an individual patient. The median (IQR) estimated chance that warfarin would prevent a stroke in the next year was 50% (5%-80%) compared with scientific evidence, which indicates an absolute risk reduction (ARR) of 0.2% to 1.0% based on a relative risk reduction (RRR) of 39% to 50%. The median (IQR) estimated chance that antihypertensive therapy would prevent a cardiovascular event within 5 years was 30% (10%-70%) vs evidence of an ARR of 0% to 3% based on an RRR of 0% to 28%. The median (IQR) estimated chance that bisphosphonate therapy would prevent a hip fracture in the next 5 years was 40% (10%-60%) vs evidence of ARR of 0.1% to 0.4% based on an RRR of 20% to 40%. The median (IQR) estimated chance that moderate-intensity statin therapy would prevent a cardiovascular event in the next 5 years was 20% (IQR 5%-50%) vs evidence of an ARR of 0.3% to 2% based on an RRR of 19% to 33%. Estimates of the chance that a treatment would prevent an adverse outcome exceeded estimates of the absolute chance of that outcome for 60% to 70% of clinicians. Clinicians whose overestimations were greater were more likely to report using that treatment for patients in their practice (eg, use of warfarin: correlation coefficient, 0.46; 95% CI, 0.40-0.53; P < .001)., Conclusions and Relevance: In this survey study, clinicians significantly overestimated the benefits of treatment to individual patients. Clinicians with greater overestimates were more likely to report using treatments in actual patients.

Importance: Poor work-life integration (WLI) occurs when career and personal responsibilities come in conflict and may contribute to the ongoing high rates of physician burnout. The characteristics associated with WLI are poorly understood., Objective: To identify personal and professional factors associated with WLI in physicians and identify factors that modify the association between gender and WLI., Design, Setting, and Participants: This cross-sectional study was based on electronic and paper surveys administered October 2017 to March 2018 at private, academic, military, and veteran's practices across the US. It used a population-based sample of US physicians across all medical specialties. Data analysis was performed from November 2019 to July 2020., Main Outcomes and Measures: WLI was assessed using an 8-item scale (0-100 point scale, with higher scores indicating favorable WLI), alongside personal and professional factors. Multivariable linear regressions evaluated independent associations with WLI as well as factors that modify the association between gender and WLI., Results: Of 5197 physicians completing surveys, 4370 provided complete responses. Of the physicians who provided complete responses, 2719 were men, 3491 were White/Caucasian (80.8%), 3560 were married (82.4%), and the mean (SD) age was 52.3 (12.0) years. The mean (SD) WLI score was 55 (23). Women reported lower (worse) mean (SD) WLI scores than men overall (52 [22] vs 57 [23]; mean difference, -5 [-0.2 SDs]; P < .001). In multivariable regression, lower WLI was independently associated with being a woman (linear regression coefficient, -6; SE, 0.7; P < .001) as well as being aged 35 years or older (eg, aged 35 to 44 years: linear regression coefficient, -7; SE, 1.4; P < .001), single (linear regression coefficient, -3 vs married; SE, 1.1; P = .003), working more hours (eg, 50 to 59 hours per week vs less than 40 hours per week: linear regression coefficient, -9; SE, 1.0; P < .001) and call nights (linear regression coefficient, -1 for each call night per week; SE, 0.2; P < .001), and being in emergency medicine (linear regression coefficient, -18; SE, 1.6, P < .001), urology (linear regression coefficient, -11; SE, 4.0; P = .009), general surgery (linear regression coefficient, -4; SE, 2.0; P = .04), anesthesiology (linear regression coefficient, -4; SE, 1.7; P = .03), or family medicine (linear regression coefficient, -3; SE, 1.4; P = .04) (reference category, internal medicine subspecialties). In interaction modeling, physician age, youngest child's age, and hours worked per week modified the associations between gender and WLI, such that the largest gender disparities were observed in physicians who were aged 45 to 54 years (estimated WLI score for women, 49; 95% CI, 47-51; estimated WLI score for men, 57, 95% CI, 55-59; P < .001), had youngest child aged 23 years or older (estimated WLI score for women, 51; 95% CI, 48-54; estimated WLI score for men, 60; 95% CI, 58-62; P < .001), and were working less than 40 hours per week (estimated WLI score for women, 61; 95% CI, 59-63; estimated WLI score for men; 70; 95% CI, 68-72; P < .001)., Conclusions and Relevance: This study found that lower WLI was reported by physicians who are women, single, aged 35 years or older, and who work more hours and call nights. These findings suggest that systemic change is needed to improve WLI among physicians.

Importance: Hypertension and albuminuria are markers of diabetes-related nephropathy and important factors associated with kidney outcomes in pediatric type 2 diabetes. However, their prevalence in these patients is unknown., Objective: To measure the prevalence of hypertension and albuminuria in pediatric patients with type 2 diabetes and to evaluate the association of sex and race/ethnicity with these conditions., Data Sources: MEDLINE, Embase, CINAHL, Cochrane Library, Web of Science, the gray literature, and references of the screened articles were searched for human studies from date of database inception to February 20, 2020., Study Selection: Observational studies with at least 10 participants reporting the prevalence of hypertension and/or albuminuria in pediatric patients with type 2 diabetes were included. Three teams of 2 independent reviewers screened 7614 papers, of which 60 fulfilled the eligibility criteria., Data Extraction and Synthesis: Three teams of 2 independent reviewers performed data extraction, risk of bias analysis, and level of evidence analyses. The meta-analysis was conducted using a random-effects model and followed the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines., Main Outcomes and Measures: The primary outcomes included the pooled prevalence rates (percentages with 95% CI) for hypertension and albuminuria. The secondary outcomes assessed pooled prevalence rates by sex and racial/ethnic group., Results: Sixty studies were included in the systematic review. Diabetes duration varied from inclusion at diagnosis to 15.0 years after diagnosis, and the reported mean age at diagnosis ranged from 6.5 to 21.0 years. Hypertension prevalence among 3463 participants was 25.33% (95% CI, 19.57%-31.53%). Male participants had higher hypertension risk than female participants (odds ratio [OR], 1.42 [95% CI, 1.10-1.83]), with Pacific Islander and Indigenous youth having the highest prevalence of all racial/ethnic groups (Pacific Islander youth: 26.71% [95% CI, 14.54%-40.72%]; Indigenous youth: 26.48% [95% CI, 17.34%-36.74%]; White youth: 20.95% [95% CI, 12.65%-30.57%]; African American youth: 19.04% [95% CI, 12.01%-27.23%]; Hispanic/Latino youth: 15.11% [95% CI, 6.56%-26.30%]; Asian youth: 18.37% [95% CI, 9.49%-29.23%]). Albuminuria prevalence among 2250 participants was 22.17% (95% CI, 17.34%-27.38%). Pacific Islander youth, Indigenous youth, and Asian youth had higher prevalence rates than White youth (Pacific Islander youth: 31.84% [95% CI, 11.90%-55.47%]; Indigenous youth: 24.27% [95% CI, 14.39%-35.73%]; Asian youth: 23.00% [95% CI, 18.85%-27.41%]; White youth: 12.59% [95% CI, 7.75%-18.33%]), with no sex differences (OR for male vs female participants, 0.68 [95% CI, 0.46-1.01]). Heterogeneity was high among studies, with a low to moderate risk of bias., Conclusions and Relevance: In this study, markers of diabetes-related nephropathy were commonly detected in pediatric patients with type 2 diabetes, with a disproportionate burden noted among Pacific Islander and Indigenous youth. Personalized management strategies to target kidney outcomes are urgently needed in pediatric patients with type 2 diabetes to alleviate the burden of this condition on the kidneys.

Importance: The collection of patient-reported outcomes (PROs) has garnered intense interest, but dissemination of PRO programs has been limited, as have analyses of the factors associated with successful programs., Objective: To identify factors associated with improving PRO collection rates within a large health care system using a centralized PRO infrastructure., Design, Setting, and Participants: This cohort study included 205 medical and surgical clinics in the Partners Healthcare system in Massachusetts that implemented a PRO program between March 15, 2014, and December 31, 2018, using a standardized centralized infrastructure. Data were analyzed from March to April 2019., Exposures: Relevant clinical characteristics were recorded for each clinic launching a PRO program., Main Outcomes and Measures: The primary outcome was the mean PRO collection rate during each clinic's most recent 6 months of collection prior to January 2019. Data were analyzed using a linear regression model with the 6-month PRO collection rate as the dependent variable and clinic characteristics as independent variables. Secondary analysis used a logistic regression model to assess clinical factors associated with successful clinics, defined as those that collected PROs at a rate greater than 50%., Results: Between March 2014 and December 2018, 205 Partners Healthcare clinics were available for analysis, and 4 061 205 PRO measures from 745 028 encounters were collected. Among these, 103 clinics (50.2%) collected at a rate greater than 50%. Increased collection rates were associated with more than 50% of physicians in a clinic trained on PROs (change, 19.6% [95% CI, 9.9%-29.4%]; P < .001), routine administrative oversight of collection rates (change, 16.0% [95% CI, 6.6%-25.5%]; P = .001), previous collection of PROs on paper (change, 12.5% [95% CI, 4.7%-20.3%]; P = .002), presence of a clinical champion (change, 11.2% [95% CI, 2.5%-20.0%]; P = .01) and payer incentive (change, 10.5% [95% CI, 2.0%-18.9%]; P = .02)., Conclusions and Relevance: These findings suggest that training physicians on the use of PROs, administrative surveillance of collection rates, and the presence of a local clinical champion may be promising interventions for increasing PRO collection. Clinics that have previously collected PROs may have greater success in increasing collections. Payer incentive for collection was associated with improved collections, but not associated with successful programs.

Importance: Following the adoption of electronic health records into a regulatory environment designed for paper records, there has been little investigation into the accuracy of physician documentation., Objective: To quantify the percentage of emergency physician documentation of the review of systems (ROS) and physical examination (PE) that observers can confirm., Design, Setting, and Participants: This case series took place at emergency departments in 2 academic medical centers between 2016 and 2018. Participants' patient encounters were observed to compare real-time performance with clinical documentation., Exposures: Resident physicians were shadowed by trained observers for 20 encounters (10 encounters per physician per site) to obtain real-time observational data; associated electronic health record data were subsequently reviewed., Main Outcomes and Measures: Number of confirmed ROS systems (range, 0-14) divided by the number of documented ROS systems (range, 0-14), and number of confirmed PE systems (range, 0-14) divided by the number of documented PE systems (range, 0-14)., Results: The final study cohort included 9 licensed emergency medicine residents who evaluated a total of 180 patients (mean [SD] age, 48.7 [20.0] years; 91 [50.5%] women). For ROS, physicians documented a median (interquartile range [IQR]) of 14 (8-14) systems, while audio recordings confirmed a median (IQR) of 5 (3-6) systems. Overall, 755 of 1961 documented ROS systems (38.5%) were confirmed by audio recording data. For PE, resident physicians documented a median (IQR) of 8 (7-9) verifiable systems, while observers confirmed a median (IQR) of 5.5 (3-6) systems. Overall, 760 of 1429 verifiable documented PE systems (53.2%) were confirmed by concurrent observation. Interrater reliability for rating of ROS and PE was more than 90% for all measures., Conclusions and Relevance: In this study of 9 licensed year emergency medicine residents, there were inconsistencies between the documentation of ROS and PE findings in the electronic health record and observational reports. These findings raise the possibility that some documentation may not accurately represent physician actions. Further studies should be undertaken to determine whether this occurrence is widespread. However, because such studies are unlikely to be performed owing to institution-level barriers that exist nationwide, payers should consider removing financial incentives to generate lengthy documentation.

Importance: Sources of data in the intensive care setting are increasing exponentially, but the benefits of displaying multiparametric, high-frequency data are unknown. Decision making may not benefit from this technology if clinicians remain cognitively overburdened by poorly designed data integration and visualization technologies (DIVTs)., Objective: To systematically review and summarize the published evidence on the association of user-centered DIVTs with intensive care clinician performance., Data Sources: MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and Web of Science were searched in May 2014 and January 2018., Study Selection: Studies had 3 requirements: (1) the study tested a viable DIVT, (2) participants involved were intensive care clinicians, and (3) the study reported quantitative results associated with decision making in an intensive care setting., Data Extraction and Synthesis: Of 252 records screened, 20 studies, published from 2004 to 2016, were included. The human factors framework to assess health technologies was applied to measure study completeness, and the Quality Assessment Instrument was used to assess the quality of the studies. PRISMA guidelines were adapted to conduct the systematic review and meta-analysis., Main Outcomes and Measures: Study completeness and quality; clinician performance; physical, mental, and temporal demand; effort; frustration; time to decision; and decision accuracy., Results: Of the 20 included studies, 16 were experimental studies with 410 intensive care clinician participants and 4 were survey-based studies with 1511 respondents. Scores for study completeness ranged from 27 to 43, with a maximum score of 47, and scores for study quality ranged from 46 to 79, with a maximum score of 90. Of 20 studies, DIVTs were evaluated in clinical settings in 2 studies (10%); time to decision was measured in 14 studies (70%); and decision accuracy was measured in 11 studies (55%). Measures of cognitive workload pooled in the meta-analysis suggested that any DIVT was an improvement over paper-based data in terms of self-reported performance, mental and temporal demand, and effort. With a maximum score of 22, median (IQR) mental demand scores for electronic display were 10 (7-13), tabular display scores were 8 (6.0-11.5), and novel visualization scores were 8 (6-12), compared with 17 (14-19) for paper. The median (IQR) temporal demand scores were also lower for all electronic visualizations compared with paper, with scores of 8 (6-11) for electronic display, 7 (6-11) for tabular and bar displays, 7 (5-11) for novel visualizations, and 16 (14.3-19.0) for paper. The median (IQR) performance scores improved for all electronic visualizations compared with paper (lower score indicates better self-reported performance), with scores of 6 (3-11) for electronic displays, 6 (4-11) for tabular and bar displays, 6 (4-11) for novel visualizations, and 14 (11-16) for paper. Frustration and physical demand domains of cognitive workload did not change, and differences between electronic displays were not significant., Conclusions and Relevance: This review suggests that DIVTs are associated with increased integration and consistency of data. Much work remains to identify which visualizations effectively reduce cognitive workload to enhance decision making based on intensive care data. Standardizing human factors testing by developing a repository of open access benchmarked test protocols, using a set of outcome measures, scenarios, and data sets, may accelerate the design and selection of the most appropriate DIVT.

Importance: Cannabis legalization and commercialization have introduced novel alternative cannabis products, including edible and vaporized cannabis that might appeal to youth and be associated with polyuse (ie, use of ≥2 different products)., Objective: To investigate the prevalence, patterns, and sociodemographic correlates of cannabis product use across combustible, edible, and vaporized administration methods, including polyuse of cannabis via multiple administration methods., Design, Setting, and Participants: This cross-sectional survey study included 10th-grade students from 10 Los Angeles, California, area high schools from January 2 through October 6, 2015. Students were recruited from respondents in the Happiness and Health Study, an ongoing prospective cohort study in the 10 high schools. Students not in school during administration of the pencil-and-paper survey completed abbreviated surveys by telephone, internet, or mail. Data were analyzed from July 17, 2017, through July 12, 2018., Exposures: Self-reported sex, race/ethnicity, and socioeconomic status (SES). Students with high SES had parents who attained college or a higher educational level and were ineligible for free or subsidized lunch; those with low SES had parents with lower educational attainment or were eligible for free or subsidized lunch., Main Outcomes and Measures: Self-report of ever use (yes or no) and past 30-day use (yes or no) status and frequency of use (days in past 30 days) of combustible, edible, and vaporized cannabis., Results: The sample included 3177 tenth-grade students (93.5% of study enrollees); among these students, 1715 (54.0%) were girls and the mean (SD) age was 16.1 (0.4) years. Among those with available demographic data, respondents were diverse in race/ethnicity (537 [17.2%] Asian; 149 [4.8%] black; 1510 [48.3%] Hispanic; 507 [16.2%] white; 207 [6.6%] multiethnic/multiracial; and 216 [6.9%] other) and included 1654 (60.1%) with a low SES. Prevalence of ever use was highest for combustible products (993 [31.3%]), followed by edible (676 [21.3%]) and vaporized (333 [10.5%]) products. A similar pattern was found for past 30-day use (426 [13.4%] for combustible, 249 [7.8%] for edible, and 156 [4.9%] for vaporized cannabis). Among participants who reported using cannabis in the past 30 days, mean frequency of use of combustible cannabis was higher by 2.65 days (95% CI, 1.40-3.91 days, P = .001) than the mean frequency of use for edible cannabis and 1.75 days higher (95% CI, 0.59-2.90 days, P = .003) than frequency of use for vaporized cannabis. Most cannabis users (665 [61.7%]) used multiple administration methods, and 260 (8.2%) used all 3 methods. Boys had higher prevalence of ever use for vaporized (170 [11.6%] vs 163 [9.5%]) but not combustible (459 [31.4%] vs 534 [31.1%]) or edible (303 [20.7%] vs 373 [21.7%]) cannabis. Respondents with low SES had higher prevalence of ever use for combustible (614 [37.1%] vs 242 [22.0%]) and edible (408 [24.7%] vs 166 [15.1%]) but not vaporized (186 [11.2%] vs 93 [8.5%]) cannabis., Conclusions and Relevance: Among 10th-grade students in Los Angeles, use of cannabis via alternative administration methods was of appreciable prevalence, predominately reported in conjunction with other cannabis products and unequally distributed across sociodemographic strata. Prevention programs and regulatory restrictions addressing the spectrum of cannabis products might benefit pediatric public health.