RESUMO
Randomized clinical trials (RCTs) often suffer from a lack of representation from historically marginalized populations, and it is uncertain whether virtual RCTs (vRCTs) enhance representativeness or if elements of their consent and enrollment processes may instead contribute to underrepresentation of these groups. In this study, we aimed to identify disparities in enrollment demographics in a vRCT, the BE ACTIVE study, which recruited patients within a single health system. We discovered that the proportions of eligible patients who were randomized differed significantly by gender and race/ethnicity (men 1.2%, women 2.0%, P < .001; White 1.8%, Black 1.3%, Hispanic 0.7%, Asian 0.9%; P < .001), and compared with White patients, non-White patients were less likely to have a valid email address on file and were less likely to click on the email link to the study webpage and begin enrollment.
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Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Etnicidade , Grupos Raciais/estatística & dados numéricos , Idoso , Adulto , Estados Unidos/epidemiologia , Disparidades em Assistência à Saúde/etnologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Hispânico ou Latino/estatística & dados numéricosRESUMO
What is the best way to split one stratum into two to maximally reduce the within-stratum imbalance in many covariates? We formulate this as an integer program and approximate the solution by randomized rounding of a linear program. A linear program may assign a fraction of a person to each refined stratum. Randomized rounding views fractional people as probabilities, assigning intact people to strata using biased coins. Randomized rounding is a well-studied theoretical technique for approximating the optimal solution of certain insoluble integer programs. When the number of people in a stratum is large relative to the number of covariates, we prove the following new results: (i) randomized rounding to split a stratum does very little randomizing, so it closely resembles the linear programming relaxation without splitting intact people; (ii) the linear relaxation and the randomly rounded solution place lower and upper bounds on the unattainable integer programming solution; and because of (i), these bounds are often close, thereby ratifying the usable randomly rounded solution. We illustrate using an observational study that balanced many covariates by forming matched pairs composed of 2016 patients selected from 5735 using a propensity score. Instead, we form 5 propensity score strata and refine them into 10 strata, obtaining excellent covariate balance while retaining all patients. An R package optrefine at CRAN implements the method. Supplementary materials are available online.
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Pontuação de Propensão , Humanos , Modelos Estatísticos , Biometria/métodos , Simulação por ComputadorRESUMO
Importance: Handheld phone use while driving is a major factor in vehicle crashes. Scalable interventions are needed to encourage drivers not to use their phones. Objective: To test whether interventions involving social comparison feedback and/or financial incentives can reduce drivers' handheld phone use. Design, Setting, and Participants: In a randomized clinical trial, interventions were administered nationwide in the US via a mobile application in the context of a usage-based insurance program (Snapshot Mobile application). Customers were eligible to be invited to participate in the study if enrolled in the usage-based insurance program for 30 to 70 days. The study was conducted from May 13 to June 30, 2019. Analysis was completed December 22, 2023. Interventions: Participants were randomly assigned to 1 of 6 trial arms for a 7-week intervention period: (1) control; (2) feedback, with weekly push notification about their handheld phone use compared with that of similar others; (3) standard incentive, with a maximum $50 award at the end of the intervention based on how their handheld phone use compared with similar others; (4) standard incentive plus feedback, combining interventions of arms 2 and 3; (5) reframed incentive plus feedback, with a maximum $7.15 award each week, framed as participant's to lose; and (6) doubled reframed incentive plus feedback, a maximum $14.29 weekly loss-framed award. Main Outcome and Measure: Proportion of drive time engaged in handheld phone use in seconds per hour (s/h) of driving. Analyses were conducted with the intention-to-treat approach. Results: Of 17â¯663 customers invited by email to participate, 2109 opted in and were randomized. A total of 2020 drivers finished the intervention period (68.0% female; median age, 30 [IQR, 25-39] years). Median baseline handheld phone use was 216 (IQR, 72-480) s/h. Relative to control, feedback and standard incentive participants did not reduce their handheld phone use. Standard incentive plus feedback participants reduced their use by -38 (95% CI, -69 to -8) s/h (P = .045); reframed incentive plus feedback participants reduced their use by -56 (95% CI, -87 to -26) s/h (P < .001); and doubled reframed incentive plus feedback participants reduced their use by -42 s/h (95% CI, -72 to -13 s/h; P = .007). The 5 active treatment arms did not differ significantly from each other. Conclusions and Relevance: In this randomized clinical trial, providing social comparison feedback plus incentives reduced handheld phone use while individuals were driving. Trial Registration: ClinicalTrials.gov Identifier: NCT03833219.
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Condução de Veículo , Motivação , Humanos , Feminino , Masculino , Adulto , Condução de Veículo/psicologia , Condução de Veículo/estatística & dados numéricos , Pessoa de Meia-Idade , Uso do Telefone Celular/estatística & dados numéricos , Aplicativos Móveis , Retroalimentação , Estados UnidosRESUMO
BACKGROUND: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline-recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally designed gamification, loss-framed financial incentives, or their combination on physical activity compared with attention control over 12-month intervention and 6-month postintervention follow-up periods. METHODS: Between May 2019 and January 2024, participants with clinical atherosclerotic cardiovascular disease or a 10-year risk of myocardial infarction, stroke, or cardiovascular death of ≥7.5% by the Pooled Cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n=151), behaviorally designed gamification (n=304), loss-framed financial incentives (n=302), or gamification+financial incentives (n=305). The primary outcome of the trial was the change in mean daily steps from baseline through the 12-month intervention period. RESULTS: A total of 1062 patients (mean±SD age, 67±8; 61% female; 31% non-White) were enrolled. Compared with control subjects, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0 [95% CI, 186.2-889.9]; P=0.0027), financial incentives arm (adjusted difference, 491.8 [95% CI, 139.6-844.1]; P=0.0062), and gamification+financial incentives arm (adjusted difference, 868.0 [95% CI, 516.3-1219.7]; P<0.0001). During the 6-month follow-up, physical activity remained significantly greater in the gamification+financial incentives arm than in the control arm (adjusted difference, 576.2 [95% CI, 198.5-954]; P=0.0028), but it was not significantly greater in the gamification (adjusted difference, 459.8 [95% CI, 82.0-837.6]; P=0.0171) or financial incentives (adjusted difference, 327.9 [95% CI, -50.2 to 706]; P=0.09) arms after adjustment for multiple comparisons. CONCLUSIONS: Behaviorally designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification+financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT03911141.
Assuntos
Doenças Cardiovasculares , Exercício Físico , Motivação , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Doenças Cardiovasculares/prevenção & controle , IdosoRESUMO
BACKGROUND AND PURPOSE: Children with cerebral malaria have an elevated risk of mortality and neurologic morbidity. Both mortality and morbidity are associated with initially increased brain volume on MR imaging, as graded by the Brain Volume Score, a subjective ordinal rating scale created specifically for brain MRIs in children with cerebral malaria. For the Brain Volume Score to be more widely clinically useful, we aimed to determine its independent reproducibility and whether it can be applicable to lower-resolution MRIs. MATERIALS AND METHODS: To assess the independent reproducibility of the Brain Volume Score, radiologists not associated with the initial study were trained to score MRIs from a new cohort of patients with cerebral malaria. These scores were then compared with survival and neurologic outcomes. To assess the applicability to lower-resolution MRI, we assigned Brain Volume Scores to brain MRIs degraded to simulate a very-low-field (64 mT) portable scanner and compared these with the original scores assigned to the original nondegraded MRIs. RESULTS: Brain Volume Scores on the new cohort of patients with cerebral malaria were highly associated with outcomes (OR for mortality = 16, P < .001). Scoring of the simulated degraded images remained consistent with the Brain Volume Scores assigned to the original higher-quality (0.35 T) images (intraclass coefficients > 0.86). CONCLUSIONS: Our findings demonstrate that the Brain Volume Score is externally valid in reproducibly predicting outcomes and can be reliably assigned to lower-resolution images.
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Malária Cerebral , Humanos , Criança , Malária Cerebral/diagnóstico por imagem , Reprodutibilidade dos Testes , Imageamento por Ressonância Magnética/métodos , Neuroimagem , Encéfalo/diagnóstico por imagemRESUMO
Importance: Increasing inpatient palliative care delivery is prioritized, but large-scale, experimental evidence of its effectiveness is lacking. Objective: To determine whether ordering palliative care consultation by default for seriously ill hospitalized patients without requiring greater palliative care staffing increased consultations and improved outcomes. Design, Setting, and Participants: A pragmatic, stepped-wedge, cluster randomized trial was conducted among patients 65 years or older with advanced chronic obstructive pulmonary disease, dementia, or kidney failure admitted from March 21, 2016, through November 14, 2018, to 11 US hospitals. Outcome data collection ended on January 31, 2019. Intervention: Ordering palliative care consultation by default for eligible patients, while allowing clinicians to opt-out, was compared with usual care, in which clinicians could choose to order palliative care. Main Outcomes and Measures: The primary outcome was hospital length of stay, with deaths coded as the longest length of stay, and secondary end points included palliative care consult rate, discharge to hospice, do-not-resuscitate orders, and in-hospital mortality. Results: Of 34â¯239 patients enrolled, 24â¯065 had lengths of stay of at least 72 hours and were included in the primary analytic sample (10â¯313 in the default order group and 13â¯752 in the usual care group; 13â¯338 [55.4%] women; mean age, 77.9 years). A higher percentage of patients in the default order group received palliative care consultation than in the standard care group (43.9% vs 16.6%; adjusted odds ratio [aOR], 5.17 [95% CI, 4.59-5.81]) and received consultation earlier (mean [SD] of 3.4 [2.6] days after admission vs 4.6 [4.8] days; P < .001). Length of stay did not differ between the default order and usual care groups (percent difference in median length of stay, -0.53% [95% CI, -3.51% to 2.53%]). Patients in the default order group had higher rates of do-not-resuscitate orders at discharge (aOR, 1.40 [95% CI, 1.21-1.63]) and discharge to hospice (aOR, 1.30 [95% CI, 1.07-1.57]) than the usual care group, and similar in-hospital mortality (4.7% vs 4.2%; aOR, 0.86 [95% CI, 0.68-1.08]). Conclusions and Relevance: Default palliative care consult orders did not reduce length of stay for older, hospitalized patients with advanced chronic illnesses, but did improve the rate and timing of consultation and some end-of-life care processes. Trial Registration: ClinicalTrials.gov Identifier: NCT02505035.
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Estado Terminal , Cuidados Paliativos , Encaminhamento e Consulta , Idoso , Feminino , Humanos , Masculino , Hospitais para Doentes Terminais , Mortalidade Hospitalar , Estado Terminal/terapia , Hospitalização , Doença Pulmonar Obstrutiva Crônica/terapia , Demência/terapia , Insuficiência Renal/terapiaRESUMO
In many medical studies, the outcome measure (such as quality of life, QOL) for some study participants becomes informatively truncated (censored, missing, or unobserved) due to death or other forms of dropout, creating a nonignorable missing data problem. In such cases, the use of a composite outcome or imputation methods that fill in unmeasurable QOL values for those who died rely on strong and untestable assumptions and may be conceptually unappealing to certain stakeholders when estimating a treatment effect. The survivor average causal effect (SACE) is an alternative causal estimand that surmounts some of these issues. While principal stratification has been applied to estimate the SACE in individually randomized trials, methods for estimating the SACE in cluster-randomized trials are currently limited. To address this gap, we develop a mixed model approach along with an expectation-maximization algorithm to estimate the SACE in cluster-randomized trials. We model the continuous outcome measure with a random intercept to account for intracluster correlations due to cluster-level randomization, and model the principal strata membership both with and without a random intercept. In simulations, we compare the performance of our approaches with an existing fixed-effects approach to illustrate the importance of accounting for clustering in cluster-randomized trials. The methodology is then illustrated using a cluster-randomized trial of telecare and assistive technology on health-related QOL in the elderly.
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Modelos Estatísticos , Qualidade de Vida , Humanos , Idoso , Ensaios Clínicos Controlados Aleatórios como Assunto , Avaliação de Resultados em Cuidados de Saúde , SobreviventesRESUMO
We pay tribute to Marshall Joffe, PhD, and his substantial contributions to the field of causal inference with focus in biostatistics and epidemiology. By compiling narratives written by us, his colleagues, we not only present highlights of Marshall's research and their significance for causal inference but also offer a portrayal of Marshall's personal accomplishments and character. Our discussion of Marshall's research notably includes (but is not limited to) handling of posttreatment variables such as noncompliance, employing G-estimation for treatment effects on failure-time outcomes, estimating effects of time-varying exposures subject to time-dependent confounding, and developing a causal framework for case-control studies. We also provide a description of some of Marshall's unpublished work, which is accompanied by a bonus anecdote. We discuss future research directions related to Marshall's research. While Marshall's impact in causal inference and the world outside of it cannot be wholly captured by our words, we hope nonetheless to present some of what he has done for our field and what he has meant to us and to his loved ones.
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Bioestatística , Humanos , Masculino , Causalidade , Estudos de Casos e ControlesRESUMO
We conduct an observational study of the effect of sickle cell trait Haemoglobin AS (HbAS) on the hazard rate of malaria fevers in children. Assuming no unmeasured confounding, there is strong evidence that HbAS reduces the rate of malarial fevers. Since this is an observational study, however, the no unmeasured confounding assumption is strong. A sensitivity analysis considers how robust a conclusion is to a potential unmeasured confounder. We propose a new sensitivity analysis method for recurrent event data and apply it to the malaria study. We find that for the causal conclusion that HbAS is protective against malarial fevers to be overturned, the hypothesized unmeasured confounder must be as influential as all but one of the measured confounders.
Assuntos
Malária , Criança , Humanos , CausalidadeRESUMO
Unmeasured confounding is a major obstacle to reliable causal inference based on observational studies. Instrumented difference-in-differences (iDiD), a novel idea connecting instrumental variable and standard DiD, ameliorates the above issue by explicitly leveraging exogenous randomness in an exposure trend. In this article, we utilize the above idea of iDiD, and propose a novel group sequential testing method that provides valid inference even in the presence of unmeasured confounders. At each time point, we estimate the average or conditional average treatment effect under iDiD setting using the data accumulated up to that time point, and test the significance of the treatment effect. We derive the joint distribution of the test statistics under the null using the asymptotic properties of M-estimation, and the group sequential boundaries are obtained using the α $$ \alpha $$ -spending functions. The performance of our proposed approach is evaluated on both synthetic data and Clinformatics Data Mart Database (OptumInsight, Eden Prairie, MN) to examine the association between rofecoxib and acute myocardial infarction, and our method detects significant adverse effect of rofecoxib much earlier than the time when it was finally withdrawn from the market.
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Viés , Estatística como Assunto , Humanos , Infarto do Miocárdio , Retirada de Medicamento Baseada em SegurançaRESUMO
Firearm-related deaths are a leading cause of death in the USA. Webster et al. (2014) found an association between Missouri's repeal of a permit-to-purchase handgun licensing law and an increase in firearm-related homicides. The evidence for causality of this association would be strengthened by finding that the increase occurred through the hypothesized mechanism of increasing the ease with which those with violent intent could obtain guns. This study examines two measures: (1) proportion of guns recovered and purchased in-state and (2) time between firearm purchase and recovery by police following criminal use. The repeal was associated from 2008 to 2019 with a 0.05 increase in the proportion own-state gun trace (p < 0.0001, 95% confidence interval: 0.08,0.13) and a 0.10 increase in the proportion of guns recovered prior to 1 year after purchase (p = 0.01, 95% confidence interval: 1.20, 1.90). Our study provides supportive evidence for the repeal increasing firearm-related homicides.
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Armas de Fogo , Suicídio , Humanos , Homicídio , Missouri/epidemiologia , Licenciamento , Comportamento do ConsumidorRESUMO
Importance: Although racial and ethnic minority patients with sepsis and acute respiratory failure (ARF) experience worse outcomes, how patient presentation characteristics, processes of care, and hospital resource delivery are associated with outcomes is not well understood. Objective: To measure disparities in hospital length of stay (LOS) among patients at high risk of adverse outcomes who present with sepsis and/or ARF and do not immediately require life support and to quantify associations with patient- and hospital-level factors. Design, Setting, and Participants: This matched retrospective cohort study used electronic health record data from 27 acute care teaching and community hospitals across the Philadelphia metropolitan and northern California areas between January 1, 2013, and December 31, 2018. Matching analyses were performed between June 1 and July 31, 2022. The study included 102 362 adult patients who met clinical criteria for sepsis (n = 84â¯685) or ARF (n = 42â¯008) with a high risk of death at the time of presentation to the emergency department but without an immediate requirement for invasive life support. Exposures: Racial or ethnic minority self-identification. Main Outcomes and Measures: Hospital LOS, defined as the time from hospital admission to the time of discharge or inpatient death. Matches were stratified by racial and ethnic minority patient identity, comparing Asian and Pacific Islander patients, Black patients, Hispanic patients, and multiracial patients with White patients in stratified analyses. Results: Among 102 362 patients, the median (IQR) age was 76 (65-85) years; 51.5% were male. A total of 10.2% of patients self-identified as Asian American or Pacific Islander, 13.7% as Black, 9.7% as Hispanic, 60.7% as White, and 5.7% as multiracial. After matching racial and ethnic minority patients to White patients on clinical presentation characteristics, hospital capacity strain, initial intensive care unit admission, and the occurrence of inpatient death, Black patients experienced longer LOS relative to White patients in fully adjusted matches (sepsis: 1.26 [95% CI, 0.68-1.84] days; ARF: 0.97 [95% CI, 0.05-1.89] days). Length of stay was shorter among Asian American and Pacific Islander patients with ARF (-0.61 [95% CI, -0.88 to -0.34] days) and Hispanic patients with sepsis (-0.22 [95% CI, -0.39 to -0.05] days) or ARF (-0.47 [-0.73 to -0.20] days). Conclusions and Relevance: In this cohort study, Black patients with severe illness who presented with sepsis and/or ARF experienced longer LOS than White patients. Hispanic patients with sepsis and Asian American and Pacific Islander and Hispanic patients with ARF both experienced shorter LOS. Because matched differences were independent of commonly implicated clinical presentation-related factors associated with disparities, identification of additional mechanisms that underlie these disparities is warranted.
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Insuficiência Respiratória , Sepse , Adulto , Humanos , Masculino , Idoso , Idoso de 80 Anos ou mais , Feminino , Etnicidade , Tempo de Internação , Estudos de Coortes , Estudos Retrospectivos , Grupos Minoritários , Sepse/terapia , BrancosRESUMO
Hospital readmission prediction models often perform poorly, but most only use information collected until the time of hospital discharge. In this clinical trial, we randomly assigned 500 patients discharged from hospital to home to use either a smartphone or wearable device to collect and transmit remote patient monitoring (RPM) data on activity patterns after hospital discharge. Analyses were conducted at the patient-day level using discrete-time survival analysis. Each arm was split into training and testing folds. The training set used fivefold cross-validation and then final model results are from predictions on the test set. A standard model comprised data collected up to the time of discharge including demographics, comorbidities, hospital length of stay, and vitals prior to discharge. An enhanced model consisted of the standard model plus RPM data. Traditional parametric regression models (logit and lasso) were compared to nonparametric machine learning approaches (random forest, gradient boosting, and ensemble). The main outcome was hospital readmission or death within 30 days of discharge. Prediction of 30-day hospital readmission significantly improved when including remotely-monitored patient data on activity patterns after hospital discharge and using nonparametric machine learning approaches. Wearables slightly outperformed smartphones but both had good prediction of 30-day hospital-readmission.
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Readmissão do Paciente , Dispositivos Eletrônicos Vestíveis , Humanos , Alta do Paciente , Monitorização Fisiológica , HospitaisRESUMO
Peer comparison feedback is a promising strategy for reducing opioid prescribing and opioid-related harms. Such comparisons may be particularly impactful among underestimating clinicians who do not perceive themselves as high prescribers relative to their peers. But peer comparisons could also unintentionally increase prescribing among overestimating clinicians who do not perceive themselves as lower prescribers than peers. The objective of this study was to assess if the impact of peer comparisons varied by clinicians' preexisting opioid prescribing self-perceptions. Subgroup analysis of a randomized trial of peer comparison interventions among emergency department and urgent care clinicians was used. Generalized mixed-effects models were used to assess whether the impact of peer comparisons, alone or combined with individual feedback, varied by underestimating or overestimating prescriber status. Underestimating and overestimating prescribers were defined as those who self-reported relative prescribing amounts that were lower and higher, respectively, than actual relative baseline amounts. The primary outcome was pills per opioid prescription. Among 438 clinicians, 54% (n = 236) provided baseline prescribing self-perceptions and were included in this analysis. Overall, 17% (n = 40) were underestimating prescribers whereas 5% (n = 11) were overestimating prescribers. Underestimating prescribers exhibited a differentially greater decrease in pills per prescription compared to nonunderestimating clinicians when receiving peer comparison feedback (1.7 pills, 95% CI, -3.2 to -0.2 pills) or combined peer and individual feedback (2.8 pills, 95% CI, -4.8 to -0.8 pills). In contrast, there were no differential changes in pills per prescription for overestimating versus nonoverestimating prescribers after receiving peer comparison (1.5 pills, 95% CI, -0.9 to 3.9 pills) or combined peer and individual feedback (3.0 pills, 95% CI, -0.3 to 6.2 pills). Peer comparisons were more impactful among clinicians who underestimated their prescribing compared to peers. By correcting inaccurate self-perceptions, peer comparison feedback can be an effective strategy for influencing opioid prescribing.
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Analgésicos Opioides , Médicos , Humanos , Analgésicos Opioides/uso terapêutico , Retroalimentação , Padrões de Prática Médica , Serviço Hospitalar de EmergênciaRESUMO
BACKGROUND: Higher levels of physical activity are associated with improvements in cardiovascular health, and consensus guidelines recommend that individuals with or at risk for atherosclerotic cardiovascular disease (ASCVD) participate in regular physical activity. However, most adults do not achieve recommended levels of physical activity. Concepts from behavioral economics have been used to design scalable interventions that increase physical activity over short time periods, but the longer-term efficacy of these strategies is uncertain. STUDY DESIGN AND OBJECTIVES: BE ACTIVE (NCT03911141) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of 3 strategies informed by behavioral economic concepts to increase daily physical activity in patients with established ASCVD or 10-year ASCVD risk > 7.5% who are seen in primary care and cardiology clinics affiliated with the University of Pennsylvania Health System. Patients are contacted by email or text message, and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 33% to 50%, and are randomized 1:2:2:2 to control, gamification, financial incentives, or both gamification and financial incentives. Interventions continue for 12 months, with follow-up for an additional 6 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 1050 participants, with a primary endpoint of change from baseline in daily steps over the 12-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 6-month post-intervention follow-up period and change in moderate to vigorous physical activity over the intervention and follow-up periods. If the interventions prove effective, their effects on life expectancy will be compared with their costs in cost-effectiveness analysis. CONCLUSIONS: BE ACTIVE is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification, financial incentives, or both are superior to attention control in increasing physical activity. Its results will have important implications for strategies to promote physical activity in patients with or at risk for ASCVD, as well as for the design and implementation of pragmatic virtual clinical trials within health systems.
Assuntos
Doenças Cardiovasculares , Motivação , Adulto , Humanos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Gamificação , Exercício FísicoRESUMO
To understand how strain-process-outcome relationships in patients with sepsis may vary among hospitals. DESIGN: Retrospective cohort study using a validated hospital capacity strain index as a within-hospital instrumental variable governing ICU versus ward admission, stratified by hospital. SETTING: Twenty-seven U.S. hospitals from 2013 to 2018. PATIENTS: High-acuity emergency department patients with sepsis who do not require life support therapies. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The mean predicted probability of ICU admission across strain deciles ranged from 4.9% (lowest ICU-utilizing hospital for sepsis without life support) to 61.2% (highest ICU-utilizing hospital for sepsis without life support). The difference in the predicted probabilities of ICU admission between the lowest and highest strain deciles ranged from 9.0% (least strain-sensitive hospital) to 45.2% (most strain-sensitive hospital). In pooled analyses, emergency department patients with sepsis (n = 90,150) experienced a 1.3-day longer median hospital length of stay (LOS) if admitted initially to the ICU compared with the ward, but across the 27 study hospitals (n = 517-6,564), this effect varied from 9.0 days shorter (95% CI, -10.8 to -7.2; p < 0.001) to 19.0 days longer (95% CI, 16.7-21.3; p < 0.001). Corresponding ranges for inhospital mortality with ICU compared with ward admission revealed odds ratios (ORs) from 0.16 (95% CI, 0.03-0.99; p = 0.04) to 4.62 (95% CI, 1.16-18.22; p = 0.02) among patients with sepsis (pooled OR = 1.48). CONCLUSIONS: There is significant among-hospital variation in ICU admission rates for patients with sepsis not requiring life support therapies, how sensitive those ICU admission decisions are to hospital capacity strain, and the association of ICU admission with hospital LOS and hospital mortality. Hospital-level heterogeneity should be considered alongside patient-level heterogeneity in critical and acute care study design and interpretation.
RESUMO
Importance: Serious illness conversations (SICs) between oncology clinicians and patients are associated with improved quality of life and may reduce aggressive end-of-life care. However, most patients with cancer die without a documented SIC. Objective: To test the impact of behavioral nudges to clinicians to prompt SICs on the SIC rate and end-of-life outcomes among patients at high risk of death within 180 days (high-risk patients) as identified by a machine learning algorithm. Design, Setting, and Participants: This prespecified 40-week analysis of a stepped-wedge randomized clinical trial conducted between June 17, 2019, and April 20, 2020 (including 16 weeks of intervention rollout and 24 weeks of follow-up), included 20â¯506 patients with cancer representing 41â¯021 encounters at 9 tertiary or community-based medical oncology clinics in a large academic health system. The current analyses were conducted from June 1, 2021, to May 31, 2022. Intervention: High-risk patients were identified using a validated electronic health record machine learning algorithm to predict 6-month mortality. The intervention consisted of (1) weekly emails to clinicians comparing their SIC rates for all patients against peers' rates, (2) weekly lists of high-risk patients, and (3) opt-out text messages to prompt SICs before encounters with high-risk patients. Main Outcomes and Measures: The primary outcome was SIC rates for all and high-risk patient encounters; secondary end-of-life outcomes among decedents included inpatient death, hospice enrollment and length of stay, and intensive care unit admission and systemic therapy close to death. Intention-to-treat analyses were adjusted for clinic and wedge fixed effects and clustered at the oncologist level. Results: The study included 20 506 patients (mean [SD] age, 60.0 [14.0] years) and 41 021 patient encounters: 22 259 (54%) encounters with female patients, 28 907 (70.5%) with non-Hispanic White patients, and 5520 (13.5%) with high-risk patients; 1417 patients (6.9%) died by the end of follow-up. There were no meaningful differences in demographic characteristics in the control and intervention periods. Among high-risk patient encounters, the unadjusted SIC rates were 3.4% (59 of 1754 encounters) in the control period and 13.5% (510 of 3765 encounters) in the intervention period. In adjusted analyses, the intervention was associated with increased SICs for all patients (adjusted odds ratio, 2.09 [95% CI, 1.53-2.87]; P < .001) and decreased end-of-life systemic therapy (7.5% [72 of 957 patients] vs 10.4% [24 of 231 patients]; adjusted odds ratio, 0.25 [95% CI, 0.11-0.57]; P = .001) relative to controls, but there was no effect on hospice enrollment or length of stay, inpatient death, or end-of-life ICU use. Conclusions and Relevance: In this randomized clinical trial, a machine learning-based behavioral intervention and behavioral nudges to clinicans led to an increase in SICs and reduction in end-of-life systemic therapy but no changes in other end-of-life outcomes among outpatients with cancer. These results suggest that machine learning and behavioral nudges can lead to long-lasting improvements in cancer care delivery. Trial Registration: ClinicalTrials.gov Identifier: NCT03984773.
Assuntos
Neoplasias , Qualidade de Vida , Humanos , Feminino , Pessoa de Meia-Idade , Neoplasias/terapia , Comunicação , Aprendizado de Máquina , MorteRESUMO
Importance: Statins reduce the risk of major adverse cardiovascular events, but less than one-half of individuals in America who meet guideline criteria for a statin are actively prescribed this medication. Objective: To evaluate whether nudges to clinicians, patients, or both increase initiation of statin prescribing during primary care visits. Design, Setting, and Participants: This cluster randomized clinical trial evaluated statin prescribing of 158 clinicians from 28 primary care practices including 4131 patients. The design included a 12-month preintervention period and a 6-month intervention period between October 19, 2019, and April 18, 2021. Interventions: The usual care group received no interventions. The clinician nudge combined an active choice prompt in the electronic health record during the patient visit and monthly feedback on prescribing patterns compared with peers. The patient nudge was an interactive text message delivered 4 days before the visit. The combined nudge included the clinician and patient nudges. Main Outcomes and Measures: The primary outcome was initiation of a statin prescription during the visit. Results: The sample comprised 4131 patients with a mean (SD) age of 65.5 (10.5) years; 2120 (51.3%) were male; 1210 (29.3%) were Black, 106 (2.6%) were Hispanic, 2732 (66.1%) were White, and 83 (2.0%) were of other race or ethnicity, and 933 (22.6%) had atherosclerotic cardiovascular disease. In unadjusted analyses during the preintervention period, statins were prescribed to 5.6% of patients (105 of 1876) in the usual care group, 4.8% (97 of 2022) in the patient nudge group, 6.0% (104 of 1723) in the clinician nudge group, and 4.7% (82 of 1752) in the combined group. During the intervention, statins were prescribed to 7.3% of patients (75 of 1032) in the usual care group, 8.5% (100 of 1181) in the patient nudge group, 13.0% (128 of 981) in the clinician nudge arm, and 15.5% (145 of 937) in the combined group. In the main adjusted analyses relative to usual care, the clinician nudge significantly increased statin prescribing alone (5.5 percentage points; 95% CI, 3.4 to 7.8 percentage points; P = .01) and when combined with the patient nudge (7.2 percentage points; 95% CI, 5.1 to 9.1 percentage points; P = .001). The patient nudge alone did not change statin prescribing relative to usual care (0.9 percentage points; 95% CI, -0.8 to 2.5 percentage points; P = .32). Conclusions and Relevance: Nudges to clinicians with and without a patient nudge significantly increased initiation of a statin prescription during primary care visits. The patient nudge alone was not effective. Trial Registration: ClinicalTrials.gov Identifier: NCT04307472.
Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases , Idoso , Feminino , Humanos , Masculino , Registros Eletrônicos de Saúde , Hispânico ou Latino , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Pacientes , Atenção Primária à SaúdeRESUMO
In malaria endemic areas, a high proportion of children have detectable parasitemia but show no clinical symptoms. When comatose from a cause other than malaria, this group confounds the cerebral malaria (CM) definition, making accurate diagnosis challenging. One important biomarker of CM is malarial retinopathy, a set of specific features visible in the ocular fundus. In this study, we quantified the contribution of malarial retinopathy in discriminating malaria-caused coma from non-malaria-caused coma. We estimated that 10% of our study cohort of N = 1,192 patients who met the WHO clinical definition of CM in Malawi had non-malarial coma based on a Gaussian mixture model using the parasite protein Plasmodium falciparum histidine-rich protein-2. A classification based on platelets, white blood cells, and retinopathy significantly improved the discriminative power of a previously established model including only platelets plus white blood cells (area under the receiver operating characteristic curve: 0.89 versus 0.75, P value < 0.001). We conclude that malarial retinopathy is highly predictive of malaria-caused versus non-malaria-caused coma and recommend that an ocular funduscopic examination to determine malarial retinopathy status be included in the assessment of parasitemic comatose African children.
Assuntos
Malária Cerebral , Malária Falciparum , Doenças Retinianas , Criança , Humanos , Malária Cerebral/complicações , Malária Cerebral/diagnóstico , Coma , Doenças Retinianas/diagnóstico , Fundo de Olho , Biomarcadores , Malária Falciparum/complicações , Malária Falciparum/diagnóstico , Plasmodium falciparumRESUMO
Rationale: We have previously shown that hospital strain is associated with intensive care unit (ICU) admission and that ICU admission, compared with ward admission, may benefit certain patients with acute respiratory failure (ARF). Objectives: To understand how strain-process-outcomes relationships in patients with ARF may vary among hospitals and what hospital practice differences may account for such variation. Methods: We examined high-acuity patients with ARF who did not require mechanical ventilation or vasopressors in the emergency department (ED) and were admitted to 27 U.S. hospitals from 2013 to 2018. Stratifying by hospital, we compared hospital strain-ICU admission relationships and hospital length of stay (LOS) and mortality among patients initially admitted to the ICU versus the ward using hospital strain as a previously validated instrumental variable. We also surveyed hospital practices and, in exploratory analyses, evaluated their associations with the above processes and outcomes. Results: There was significant among-hospital variation in ICU admission rates, in hospital strain-ICU admission relationships, and in the association of ICU admission with hospital LOS and hospital mortality. Overall, ED patients with ARF (n = 45,339) experienced a 0.82-day shorter median hospital LOS if admitted initially to the ICU compared with the ward, but among the 27 hospitals (n = 224-3,324), this effect varied from 5.85 days shorter (95% confidence interval [CI], -8.84 to -2.86; P < 0.001) to 4.38 days longer (95% CI, 1.86-6.90; P = 0.001). Corresponding ranges for in-hospital mortality with ICU compared with ward admission revealed odds ratios from 0.08 (95% CI, 0.01-0.56; P < 0.007) to 8.89 (95% CI, 1.60-79.85; P = 0.016) among patients with ARF (pooled odds ratio, 0.75). In exploratory analyses, only a small number of measured hospital practices-the presence of a sepsis ED disposition guideline and maximum ED patient capacity-were potentially associated with hospital strain-ICU admission relationships. Conclusions: Hospitals vary considerably in ICU admission rates, the sensitivity of those rates to hospital capacity strain, and the benefits of ICU admission for patients with ARF not requiring life support therapies in the ED. Future work is needed to more fully identify hospital-level factors contributing to these relationships.