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BACKGROUND: In early-onset severe hemolytic disease of the fetus and newborn (HDFN), transplacental transfer of maternal antierythrocyte IgG alloantibodies causes fetal anemia that leads to the use of high-risk intrauterine transfusions in order to avoid fetal hydrops and fetal death. Nipocalimab, an anti-neonatal Fc receptor blocker, inhibits transplacental IgG transfer and lowers maternal IgG levels. METHODS: In an international, open-label, single-group, phase 2 study, we assessed treatment with intravenous nipocalimab (30 or 45 mg per kilogram of body weight per week) administered from 14 to 35 weeks' gestation in participants with pregnancies at high risk for recurrent early-onset severe HDFN. The primary end point was live birth at 32 weeks' gestation or later without intrauterine transfusions as assessed against a historical benchmark (0%; clinically meaningful difference, 10%). RESULTS: Live birth at 32 weeks' gestation or later without intrauterine transfusions occurred in 7 of 13 pregnancies (54%; 95% confidence interval, 25 to 81) in the study. No cases of fetal hydrops occurred, and 6 participants (46%) did not receive any antenatal or neonatal transfusions. Six fetuses received an intrauterine transfusion: five fetuses at 24 weeks' gestation or later and one fetus before fetal loss at 22 weeks and 5 days' gestation. Live birth occurred in 12 pregnancies. The median gestational age at delivery was 36 weeks and 4 days. Of the 12 live-born infants, 1 received one exchange transfusion and one simple transfusion and 5 received only simple transfusions. Treatment-related decreases in the alloantibody titer and IgG level were observed in maternal samples and cord blood. No unusual maternal or pediatric infections were observed. Serious adverse events were consistent with HDFN, pregnancy, or prematurity. CONCLUSIONS: Nipocalimab treatment delayed or prevented fetal anemia or intrauterine transfusions, as compared with the historical benchmark, in pregnancies at high risk for early-onset severe HDFN. (Funded by Janssen Research and Development; UNITY ClinicalTrials.gov number, NCT03842189.).
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Anticuerpos Monoclonales Humanizados , Transfusión de Sangre Intrauterina , Eritroblastosis Fetal , Inmunoglobulina G , Humanos , Femenino , Embarazo , Recién Nacido , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Adulto , Inmunoglobulina G/sangre , Transfusión de Sangre Intrauterina/efectos adversos , Nacimiento Vivo , Isoanticuerpos/sangre , Receptores Fc , Edad Gestacional , Antígenos de Histocompatibilidad Clase IRESUMEN
OBJECTIVE: Bariatric surgery leads to substantial improvements in weight and weight-related conditions, but prior literature on post-surgical health expenditures is equivocal. In a retrospective cohort study, we compared expenditures between surgical and matched non-surgical patients. SUMMARY BACKGROUND DATA AND METHODS: In a retrospective study, total, outpatient, inpatient and medication expenditures 3 years before and 5.5 years after surgery were compared between 22,698 bariatric surgery (n=7,127 RYGB, 15,571 sleeve gastrectomy) patients from 2012-2019 and 66,769 matched non-surgical patients, using generalized estimating equations. We also compared expenditures between patients receiving the two leading surgical procedures in weighted analyses. RESULTS: Surgical and non-surgical cohorts were well matched, 80-81% female, with mean body mass index (BMI) of 44, and mean age of 47 (RYGB) and 44 (SG) years. Estimated total expenditures were similar between surgical and non-surgical groups 3 years before surgery ($27 difference, 95% confidence interval (CI): -42, 102)), increased 6 months prior to surgery for surgical patients, and decreased below pre-period levels for both groups after 3-5.5 years to become similar (difference at 5.5 y=-$61, 95% CI: -166, 52). Long-term outpatient expenditures were similar between groups. Surgical patients' lower long-term medication expenditures ($314 lower at 5.5 y, 95% CI: -419, -208) were offset by a higher risk of hospitalization. Total expenditures were similar between RYGB and SG patients 3.5 to 5.5 years after surgery. CONCLUSIONS: Bariatric surgery translated into lower medication expenditures than matched controls, but not lower overall long-term expenditures. Expenditure trends appear similar for the two leading bariatric operations.
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OBJECTIVE: The association between participation in a behavioral weight intervention and health expenditures has not been well characterized. We compared Veterans Affairs (VA) expenditures of individuals participating in MOVE!, a VA behavioral weight loss program, and matched comparators 2 years before and 2 years after MOVE! initiation. METHODS: Retrospective cohort study of Veterans who had one or more MOVE! visits in 2008-2017 who were matched contemporaneously to up to 3 comparators with overweight or obesity through sequential stratification on an array of patient characteristics, including sex. Baseline patient characteristics were compared between the two cohorts through standardized mean differences. VA expenditures in the 2 years before MOVE! initiation and 2 years after initiation were modeled using generalized estimating equations with a log link and distribution with variance proportional to the standard deviation (gamma). RESULTS: MOVE! participants (n=499,696) and comparators (n=1,336,172) were well-matched, with an average age of 56, average body mass index of 35, and similar total VA expenditures in the fiscal year before MOVE! initiation ($9662 for MOVE! participants and $10,072 for comparators, standardized mean difference=-0.019). MOVE! participants had total expenditures that were statistically lower than matched comparators in the 6 months after initiation but modestly higher in the 6 months to 2 years after initiation, though differences were small in magnitude (1.0%-1.6% differences). CONCLUSIONS: The VA's system-wide behavioral weight intervention did not realize meaningful short-term health care cost savings for participants.
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Veteranos , Programas de Reducción de Peso , Estados Unidos , Humanos , Persona de Mediana Edad , Gastos en Salud , Estudios Retrospectivos , United States Department of Veterans Affairs , Salud de los VeteranosRESUMEN
BACKGROUND: Anti-obesity medications (AOMs) can be initiated in conjunction with participation in the VA national behavioral weight management program, MOVE!, to help achieve clinically meaningful weight loss. OBJECTIVE: To compare weight change between Veterans who used AOM + MOVE! versus MOVE! alone and examine AOM use, duration, and characteristics associated with longer duration of use. DESIGN: Retrospective cohort study using VA electronic health records. PARTICIPANTS: Veterans with overweight or obesity who participated in MOVE! from 2008-2017. MAIN MEASURES: Weight change from baseline was estimated using marginal structural models up to 24 months after MOVE! initiation. The probability of longer duration of AOM use (≥ 180 days) was estimated via a generalized linear mixed model. RESULTS: Among MOVE! participants, 8,517 (1.6%) used an AOM within 24 months after MOVE! initiation with a median of 90 days of cumulative supply. AOM + MOVE! users achieved greater weight loss than MOVE! alone users at 6 (3.2% vs. 1.6%, p < 0.001), 12 (3.4% vs. 1.4%, p < 0.001), and 24 months (2.7% vs. 1.5%, p < 0.001), and had a greater probability of achieving ≥ 5% weight loss at 6 (38.8% vs. 26.0%, p < 0.001), 12 (43.1% vs. 28.4%, p < 0.001), and 24 months (40.4% vs. 33.3%, p < 0.001). Veterans were more likely to have ≥ 180 days of supply if they were older, exempt from medication copays, used other medications with significant weight-gain, significant weight-loss, or modest weight-loss side effects, or resided in the West North Central or Pacific regions. Veterans were less likely to have ≥ 180 days of AOM supply if they had diabetes or initiated MOVE! later in the study period. CONCLUSIONS: AOM use following MOVE! initiation was uncommon, and exposure was time-limited. AOM + MOVE! was associated with a higher probability of achieving clinically significant weight loss than MOVE! alone.
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Fármacos Antiobesidad , Veteranos , Programas de Reducción de Peso , Estados Unidos , Humanos , Estudios Retrospectivos , United States Department of Veterans Affairs , Pérdida de PesoRESUMEN
BACKGROUND: Prior research demonstrates that SARS-COV-2 infection can be associated with a broad range of mental health outcomes including depression symptoms. Veterans, in particular, may be at elevated risk of increased depression following SARS-COV-2 infection given their high rates of pre-existing mental and physical health comorbidities. However, few studies have tried to isolate SARS-COV-2 infection associations with long term, patient-reported depression symptoms from other factors (e.g., physical health comorbidities, pandemic-related stress). OBJECTIVE: To evaluate the association between SARS-COV-2 infection and subsequent depression symptoms among United States Military Veterans. DESIGN: Survey-based non-randomized cohort study with matched comparators. PARTICIPANTS: A matched-dyadic sample from a larger, stratified random sample of participants with and without known to SARS-COV-2 infection were invited to participate in a survey evaluating mental health and wellness 18-months after their index infection date. Sampled participants were stratified by infection severity of the participant infected with SARS-COV-2 (hospitalized or not) and by month of index date. A total of 186 participants in each group agreed to participate in the survey and had sufficient data for inclusion in analyses. Those in the uninfected group who were later infected were excluded from analyses. MAIN MEASURES: Participants were administered the Patient Health Questionnaire-9 as part of a phone interview survey. Demographics, physical and mental health comorbidities were extracted from VHA administrative data. KEY RESULTS: Veterans infected with SARS-COV-2 had significantly higher depression symptoms scores compared with those uninfected. In particular, psychological symptoms (e.g., low mood, suicidal ideation) scores were elevated relative to the comparator group (MInfected = 3.16, 95%CI: 2.5, 3.8; MUninfected = 1.96, 95%CI: 1.4, 2.5). Findings were similar regardless of history of depression. CONCLUSION: SARS-COV-2 infection was associated with more depression symptoms among Veterans at 18-months post-infection. Routine evaluation of depression symptoms over time following SARS-COV-2 infection is important to facilitate adequate assessment and treatment.
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COVID-19 , Depresión , Veteranos , Humanos , COVID-19/psicología , COVID-19/epidemiología , Veteranos/psicología , Veteranos/estadística & datos numéricos , Masculino , Femenino , Persona de Mediana Edad , Depresión/epidemiología , Depresión/psicología , Estados Unidos/epidemiología , Adulto , Anciano , Estudios de Cohortes , SARS-CoV-2RESUMEN
BACKGROUND: Negative mental health-related effects of SARS-COV-2 infection are increasingly evident. However, the impact on suicide-related outcomes is poorly understood, especially among populations at elevated risk. OBJECTIVE: To determine risk of suicide attempts and other self-directed violence (SDV) after SARS-COV-2 infection in a high-risk population. DESIGN: We employed an observational design supported by comprehensive electronic health records from the Veterans Health Administration (VHA) to examine the association of SARS-COV-2 infection with suicide attempts and other SDV within one year of infection. Veterans with SARS-COV-2 infections were matched 1:5 with non-infected comparators each month. Three periods after index were evaluated: days 1-30, days 31-365, and days 1-365. PARTICIPANTS: VHA patients infected with SARS-COV-2 between March 1, 2020 and March 31, 2021 and matched non-infected Veteran comparators. MAIN MEASURES: Suicide attempt and other SDV events for the COVID-19 and non-infected comparator groups were analyzed using incidence rates per 100,000 person years and hazard ratios from Cox regressions modeling time from matched index date to first event. Subgroups were also examined. KEY RESULTS: 198,938 veterans with SARS-COV-2 (COVID-19 group) and 992,036 comparators were included. Unadjusted one-year incidence per 100,000 for suicide attempt and other SDV was higher among the COVID-19 group: 355 vs 250 and 327 vs 235, respectively. The COVID-19 group had higher risk than comparators for suicide attempts: days 1-30 hazard ratio (HR) = 2.54 (CI:2.05, 3.15), days 31-365 HR = 1.30 (CI:1.19, 1.43) and days 1-365 HR = 1.41 (CI:1.30, 1.54), and for other SDV: days 1-30 HR = 1.94 (CI:1.51, 2.49), days 31-365 HR = 1.32 (CI:1.20, 1.45) and days 1-365 HR = 1.38 (CI:1.26, 1.51). CONCLUSIONS: COVID-19 patients had higher risks of both suicide attempts and other forms of SDV compared to uninfected comparators, which persisted for at least one year after infection. Results support suicide risk screening of those infected with SARS-COV-2 to identify opportunities to prevent self-harm.
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COVID-19 , Veteranos , Humanos , SARS-CoV-2 , Intento de Suicidio , Registros Electrónicos de SaludRESUMEN
BACKGROUND: Research suggests an association between COVID-19 infection and certain financial hardships in the shorter term and among single-state and privately insured samples. Whether COVID-19 is associated with financial hardship in the longer-term or among socially vulnerable populations is unknown. Therefore, we examined whether COVID-19 was associated with a range of financial hardships 18 months after initial infection among a national cohort of Veterans enrolled in the Veterans Health Administration (VHA)-the largest national integrated health system in the US. We additionally explored the association between Veteran characteristics and financial hardship during the pandemic, irrespective of COVID-19. METHODS: We conducted a prospective, telephone-based survey. Out of 600 Veterans with COVID-19 from October 2020 through April 2021 who were invited to participate, 194 Veterans with COVID-19 and 194 matched comparators without a history of infection participated. Financial hardship outcomes included overall health-related financial strain, two behavioral financial hardships (e.g., taking less medication than prescribed due to cost), and seven material financial hardships (e.g., using up most or all savings). Weighted generalized estimating equations were used to estimate risk ratios (RR) and 95% confidence intervals (CI) of financial hardship by COVID-19 status, and to assess the relationship between infection and Veteran age, VHA copay status, and comorbidity score, irrespective of COVID-19 status. RESULTS: Among 388 respondents, 67% reported at least one type of financial hardship since March 2020, with 21% reporting behavioral hardships and 64% material hardships; 8% reported severe-to-extreme health-related financial strain. Compared with uninfected matched comparators, Veterans with a history of COVID-19 had greater risks of severe-to-extreme health-related financial strain (RR: 4.0, CI: 1.4-11.2), taking less medication due to cost (RR: 2.9, 95% CI: 1.0-8.6), and having a loved one take time off work to care for them (RR: 1.9, CI: 1.1-3.6). Irrespective of COVID-19 status, Veterans aged < 65 years had a greater risk of most financial hardships compared with Veterans aged ≥ 65 years. CONCLUSIONS: Health-related financial hardships such as taking less medication due to cost and severe-to-extreme health-related financial strain were more common among Veterans with a history of COVID-19 than among matched comparators. Strategies are needed to address health-related financial hardship after COVID-19. TRIAL REGISTRATION: NCT05394025, registered 05-27-2022.
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COVID-19 , Estrés Financiero , Veteranos , Humanos , COVID-19/epidemiología , COVID-19/economía , Estados Unidos/epidemiología , Estudios Prospectivos , Masculino , Femenino , Veteranos/estadística & datos numéricos , Persona de Mediana Edad , Estrés Financiero/epidemiología , Anciano , SARS-CoV-2 , Adulto , Pandemias/economía , United States Department of Veterans AffairsRESUMEN
OBJECTIVE: In a large multisite cohort of Veterans who underwent Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy, we compared the 5-year suicidal ideation and attempt rates with matched nonsurgical controls. BACKGROUND: Bariatric surgery has significant health benefits but has also been associated with adverse mental health outcomes. METHODS: Five-year rates of suicidal ideation and suicide attempts of Veterans who underwent Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy from the fiscal year 2000-2016 to matched nonsurgical controls using sequential stratification using cumulative incidence functions (ideation cohort: n=38,199; attempt cohort: n=38,661 after excluding patients with past-year outcome events). Adjusted differences in suicidal ideation and suicide attempts were estimated using a Cox regression with a robust sandwich variance estimator. RESULTS: In the matched cohorts for suicidal ideation analyses, the mean age was 53.47 years and the majority were males (78.7%) and White (77.7%). Over 40% were treated for depression (41.8%), had a nonrecent depression diagnosis (40.9%), and 4.1% had past suicidal ideation or suicide attempts >1 year before index. Characteristics of the suicide attempt cohort were similar. Regression results found that risk of suicidal ideation was significantly higher for surgical patients (adjusted hazard ratio=1.21, 95% CI: 1.03-1.41), as was risk of suicide attempt (adjusted hazard ratio=1.62, 95% CI: 1.22-2.15). CONCLUSIONS: Bariatric surgery appears to be associated with a greater risk of suicidal ideation and attempts than nonsurgical treatment of patients with severe obesity, suggesting that patients need careful monitoring for suicidal ideation and additional psychological support after bariatric surgery.
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Cirugía Bariátrica , Derivación Gástrica , Obesidad Mórbida , Masculino , Humanos , Persona de Mediana Edad , Femenino , Cirugía Bariátrica/psicología , Intento de Suicidio/psicología , Obesidad Mórbida/complicaciones , Obesidad Mórbida/cirugía , Obesidad Mórbida/psicología , Derivación Gástrica/métodos , Ideación SuicidaRESUMEN
RATIONALE & OBJECTIVE: Community-acquired acute kidney injury (CA-AKI) develops outside of the hospital and is the most common form of AKI globally. National estimates of CA-AKI in the United States are absent due to limited availability of laboratory data. This study leverages national data from the Veterans Health Administration (VA) to estimate incidence and risk factors of CA-AKI. STUDY DESIGN: Retrospective cohort study using national VA administrative and laboratory data to assess cumulative CA-AKI incidence. SETTING & PARTICIPANTS: VA primary care patients in 2013-2017 with recorded outpatient serum creatinine (Scr) and no history of chronic kidney disease≥stage 5. PREDICTOR: Sociodemographics, comorbidities, medication use, and health care utilization. OUTCOME: Annual incidence of CA-AKI defined as a≥1.5-fold relative increase in Scr on either a subsequent outpatient Scr or inpatient Scr obtained within ≤24 hours of admission. ANALYTICAL APPROACH: We calculated the relative change in Scr within 12 months of an outpatient Scr value. A Cox model was used to estimate the association between CA-AKI and baseline characteristics, accounting for repeated measurements. RESULTS: Of approximately 2.5 million eligible veterans each year, the cumulative incidence of CA-AKI was approximately 2% annually. Only 27% of CA-AKI was detected at hospital admission. In adjusted analyses, high health care utilization, chronic illness, cancer, rural location, female sex, and use of renin-angiotensin aldosterone system inhibitors or diuretics were associated with increased CA-AKI risk (all, HR>1.20). LIMITATIONS: Limited generalizability of results outside a veteran population, lack of a standardized definition for CA-AKI, and possibility of surveillance bias and misclassification. CONCLUSIONS: CA-AKI affects 1 of every 50 US veterans annually. With less than a third of CA-AKI observed in the inpatient hospital setting, reliance on inpatient evaluation of AKI suggests significant underrecognition and missed opportunities to prevent and manage the long-term consequences of AKI.
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Lesión Renal Aguda , Insuficiencia Renal Crónica , Veteranos , Humanos , Femenino , Estudios Retrospectivos , Lesión Renal Aguda/etiología , Hospitalización , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/complicaciones , Factores de Riesgo , CreatininaRESUMEN
BACKGROUND: Obesity (body mass index [BMI]≥30kg/m2) among US adults has tripled over the past 45 years, but it is unclear how this population-level weight change has occurred. OBJECTIVE: We sought to identify distinct long-term BMI trajectories and examined associations with demographic and clinical characteristics. DESIGN: The design was latent trajectory modeling over 10 years of a retrospective cohort. Subgroups were identified via latent class growth mixture models, separately by sex. Weighted multinomial logistic regressions identified factors associated with subgroup membership. PARTICIPANTS: Participants were a retrospective cohort of 292,331 males and 62,898 females enrolled in VA. MAIN MEASURES: The main outcome measure was 6-month average VA-measured BMI over the course of 10 years. Additional electronic health record measures on demographic, clinical, and services utilization characteristics were also used to characterize latent trajectories. KEY RESULTS: Four trajectories were identified for men and for women, corresponding to standard BMI categories "normal weight" (BMI <25), "overweight" (BMI 25-29.99), and "with obesity" (BMI ≥30): "normal weight" and increasing (males: 28.4%; females: 22.8%), "overweight" and increasing (36.4%; 35.6%), "with obesity" and increasing (33.6%; 40.0%), and "with obesity" and stable (males: 1.6%) or decreasing (females: 1.6%). Race, ethnicity, comorbidities, mental health diagnoses, and mental health service utilization discriminated among classes. CONCLUSIONS: BMI in the 10 years following VA enrollment increased modestly. VA should continue prioritizing weight management interventions to the large number of veterans with obesity upon VA enrollment, because the majority remain with obesity.
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Veteranos , Masculino , Adulto , Humanos , Femenino , Índice de Masa Corporal , Estudios Retrospectivos , Alta del Paciente , Estudios Longitudinales , Factores de Riesgo , Obesidad/epidemiología , Obesidad/terapiaRESUMEN
BACKGROUND: Understanding how SARS-CoV-2 infection impacts long-term patient outcomes requires identification of comparable persons with and without infection. We report the design and implementation of a matching strategy employed by the Department of Veterans Affairs' (VA) COVID-19 Observational Research Collaboratory (CORC) to develop comparable cohorts of SARS-CoV-2 infected and uninfected persons for the purpose of inferring potential causative long-term adverse effects of SARS-CoV-2 infection in the Veteran population. METHODS: In a retrospective cohort study, we identified VA health care system patients who were and were not infected with SARS-CoV-2 on a rolling monthly basis. We generated matched cohorts within each month utilizing a combination of exact and time-varying propensity score matching based on electronic health record (EHR)-derived covariates that can be confounders or risk factors across a range of outcomes. RESULTS: From an initial pool of 126,689,864 person-months of observation, we generated final matched cohorts of 208,536 Veterans infected between March 2020-April 2021 and 3,014,091 uninfected Veterans. Matched cohorts were well-balanced on all 39 covariates used in matching after excluding patients for: no VA health care utilization; implausible age, weight, or height; living outside of the 50 states or Washington, D.C.; prior SARS-CoV-2 diagnosis per Medicare claims; or lack of a suitable match. Most Veterans in the matched cohort were male (88.3%), non-Hispanic (87.1%), white (67.2%), and living in urban areas (71.5%), with a mean age of 60.6, BMI of 31.3, Gagne comorbidity score of 1.4 and a mean of 2.3 CDC high-risk conditions. The most common diagnoses were hypertension (61.4%), diabetes (34.3%), major depression (32.2%), coronary heart disease (28.5%), PTSD (25.5%), anxiety (22.5%), and chronic kidney disease (22.5%). CONCLUSION: This successful creation of matched SARS-CoV-2 infected and uninfected patient cohorts from the largest integrated health system in the United States will support cohort studies of outcomes derived from EHRs and sample selection for qualitative interviews and patient surveys. These studies will increase our understanding of the long-term outcomes of Veterans who were infected with SARS-CoV-2.
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COVID-19 , Veteranos , Humanos , Masculino , Anciano , Estados Unidos/epidemiología , Persona de Mediana Edad , Femenino , COVID-19/epidemiología , SARS-CoV-2 , Estudios Retrospectivos , Prueba de COVID-19 , MedicareRESUMEN
PURPOSE: This study explored Veteran and family member perspectives on factors that drive post-traumatic stress disorder (PTSD) therapy engagement within constructs of the Andersen model of behavioral health service utilization. Despite efforts by the Department of Veterans Affairs (VA) to increase mental health care access, the proportion of Veterans with PTSD who engage in PTSD therapy remains low. Support for therapy from family members and friends could improve Veteran therapy use. METHODS: We applied a multiple methods approach using data from VA administrative data and semi-structured individual interviews with Veterans and their support partners who applied to the VA Caregiver Support Program. We integrated findings from a machine learning analysis of quantitative data with findings from a qualitative analysis of the semi-structured interviews. RESULTS: In quantitative models, Veteran medical need for health care use most influenced treatment initiation and retention. However, qualitative data suggested mental health symptoms combined with positive Veteran and support partner treatment attitudes motivated treatment engagement. Veterans indicated their motivation to seek treatment increased when family members perceived treatment to be of high value. Veterans who experienced poor continuity of VA care, group, and virtual treatment modalities expressed less care satisfaction. Prior marital therapy use emerged as a potentially new facilitator of PTSD treatment engagement that warrants more exploration. CONCLUSIONS: Our multiple methods findings represent Veteran and support partner perspectives and show that amid Veteran and organizational barriers to care, attitudes and support of family members and friends still matter. Family-oriented services and intervention could be a gateway to increase Veteran PTSD therapy engagement.
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Servicios de Salud Mental , Trastornos por Estrés Postraumático , Veteranos , Estados Unidos , Humanos , Veteranos/psicología , Trastornos por Estrés Postraumático/terapia , Trastornos por Estrés Postraumático/psicología , Salud Mental , United States Department of Veterans AffairsRESUMEN
BACKGROUND: The effectiveness of a third mRNA COVID-19 vaccine dose (booster dose) against the Omicron (B.1.1.529) variant is uncertain, especially in older, high-risk populations. OBJECTIVE: To determine mRNA booster vaccine effectiveness (VE) against SARS-CoV-2 infection, hospitalization, and death in the Omicron era by booster type, primary vaccine type, time since primary vaccination, age, and comorbidity burden. DESIGN: Retrospective matched cohort study designed to emulate a target trial of booster vaccination versus no booster, conducted from 1 December 2021 to 31 March 2022. SETTING: U.S. Department of Veterans Affairs health care system. PARTICIPANTS: Persons who had received 2 mRNA COVID-19 vaccine doses at least 5 months earlier. INTERVENTION: Booster monovalent mRNA vaccination (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) versus no booster. MEASUREMENTS: Booster VE. RESULTS: Each group included 490 838 well-matched persons, who were predominantly male (88%), had a mean age of 63.0 years (SD, 14.0), and were followed for up to 121 days (mean, 79.8 days). Booster VE more than 10 days after a booster dose was 42.3% (95% CI, 40.6% to 43.9%) against SARS-CoV-2 infection, 53.3% (CI, 48.1% to 58.0%) against SARS-CoV-2-related hospitalization, and 79.1% (CI, 71.2% to 84.9%) against SARS-CoV-2-related death. Booster VE was similar for different booster types (BNT162b2 or mRNA-1273), age groups, and primary vaccination regimens but was significantly higher with longer time since primary vaccination and higher comorbidity burden. LIMITATION: Predominantly male population. CONCLUSION: Booster mRNA vaccination was highly effective in preventing death and moderately effective in preventing infection and hospitalization for up to 4 months after administration in the Omicron era. Increased uptake of booster vaccination, which is currently suboptimal, should be pursued to limit the morbidity and mortality of SARS-CoV-2 infection, especially in persons with high comorbidity burden. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.
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Vacuna nCoV-2019 mRNA-1273 , COVID-19 , Estados Unidos , Humanos , Masculino , Anciano , Persona de Mediana Edad , Femenino , Vacuna BNT162 , Vacunas contra la COVID-19 , Estudios de Cohortes , Estudios Retrospectivos , SARS-CoV-2 , HospitalizaciónRESUMEN
ABSTRACT: Efforts to improve access to high-quality, efficient primary care have highlighted the need for team-based care. Most primary care teams are designed to maintain continuity of care between patients and primary care providers (PCPs), because continuity of care can improve some patient outcomes. However, PCPs are interdependent because they care for, or share, patients. PCP interdependence, and its association with continuity of care, is not well described. This study describes a measure of PCP interdependence. We also evaluate the association between patient and panel characteristics, including PCP interdependence. Our results found that the extent of interdependence between PCPs in the same clinic varies widely. A range of patient and panel characteristics affect continuity of care, including patient complexity and PCP interdependence. These results suggest that continuity of care for complex patients is sensitive to panel characteristics, including PCP interdependence and panel size. This information can be used by primary care organizations for evidence-based team design.
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Continuidad de la Atención al Paciente , Atención Primaria de Salud , Humanos , Atención Primaria de Salud/métodos , Calidad de la Atención de Salud , Instituciones de Atención AmbulatoriaRESUMEN
OBJECTIVE: In a large multisite cohort of Veterans who underwent Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG), initiation of (ie, incident) and persistence of (ie, continuation of preoperative) depression treatment are compared with matched nonsurgical controls. BACKGROUND: Bariatric surgery has been associated with short-term improvements in depression but less is known about longer term outcomes. METHODS: In a retrospective cohort study, we matched 1713 Veterans with depression treatment who underwent bariatric surgery in Veterans Administration bariatric centers from fiscal year 2001 to 2016 to 15,056 nonsurgical controls using sequential stratification and examined the persistence of depression treatment via generalized estimating equations. Incidence of depression treatment was compared using Cox regression models between 2227 surgical patients and 20,939 matched nonsurgical controls without depression treatment at baseline. RESULTS: In surgical patients with depression treatment at baseline, the use of postsurgical depression treatment declined over time for both surgical procedures, but postsurgical patients had greater use of depression treatment at 5 years [RYGB: odds ratio=1.24, 95% confidence interval (CI): 1.04-1.49; LSG: odds ratio=1.27, 95% CI: 1.04-1.56] compared with controls. Among those without depression treatment at baseline, bariatric surgery was associated with a higher incidence of depression treatment compared with matched controls (RYGB: hazard ratio=1.34, 95% CI: 1.17-1.53; LSG: hazard ratio at 1-5 years=1.27, 95% CI: 1.10-1.47). CONCLUSIONS: Bariatric surgery was associated with a greater risk of postoperative incident depression treatment and greater persistence of postoperative depression treatment. Depression may worsen for some patients after bariatric surgery, so clinicians should carefully monitor their patients for depression postoperatively.
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Cirugía Bariátrica , Depresión , Obesidad , Cirugía Bariátrica/efectos adversos , Depresión/epidemiología , Depresión/terapia , Gastrectomía/métodos , Derivación Gástrica/métodos , Humanos , Laparoscopía , Obesidad/cirugía , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Of the 26.4 million family caregivers in the United States, nearly 40% report high levels of emotional strain and subjective burden. However, for the 5 million caregivers of Veterans, little is known about the experiences of caregivers of Veterans during the coronavirus disease 2019 (COVID-19) pandemic. OBJECTIVE: The aim was to examine pandemic-related changes of caregiver well-being outcomes. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Using a pre/post design and longitudinal data of individual caregivers captured pre-COVID-19 and during COVID-19, we use multilevel generalized linear mixed models to examine pandemic-related changes to caregiver well-being (n=903). The primary outcome measures include Zarit Subjective Burden, Center for Epidemiologic Studies Short Depression Scale, perceived financial strain, life chaos, and loneliness. RESULTS: During the pandemic, we observe slight improvements for caregivers across well-being measures except for perceived financial strain. Before the pandemic, we observed that caregivers screened positive for clinically significant caregiver burden and probable depression. While we do not observe worsening indicators of caregiver well-being during the COVID-19 pandemic, the average predicted values of indicators of caregiver well-being remain clinically significant for caregiving subjective burden and depression. CONCLUSIONS: These findings illuminate pandemic-related impacts of caregivers receiving support through the Veterans Affairs (VA) pre-COVID and during the COVID-19 pandemic while caring for a population of frail, older care-recipients with a high burden of mental illness and other chronic conditions. Considering the long-term impacts of the pandemic to increase morbidity and the expected increased demand for caregivers in an aging population, these consistently high levels of distress despite receiving support highlight the need for interventions and policy reform to systematically support caregivers more broadly.
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COVID-19 , Veteranos , Anciano , COVID-19/epidemiología , Cuidadores/psicología , Enfermedad Crónica , Humanos , Pandemias , Veteranos/psicologíaRESUMEN
BACKGROUND: Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging. OBJECTIVE: To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas. DESIGN: Mixed-methods implementation study. PARTICIPANTS: 230 patients with clinic-refractory, uncontrolled T2D. INTERVENTION: ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period. MAIN MEASURES: Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). KEY RESULTS: From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years. CONCLUSIONS: When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.
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Diabetes Mellitus Tipo 2 , Telemedicina , Instituciones de Atención Ambulatoria , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Femenino , Hemoglobina Glucada , Humanos , Masculino , Población Rural , Telemedicina/métodosRESUMEN
BACKGROUND: As COVID-19 continued to impact society and health, maternity care, as with many other healthcare sectors across the globe, experienced tumultuous changes. These changes have the potential to considerably impact on the experience of maternity care. To gain insight and understanding of the experience of maternity care during COVID-19, from the perspectives of women and maternity care providers, we undertook a qualitative evidence synthesis (QES). METHODS: The population of interest for the QES were pregnant and postpartum women, and maternity care providers, who provided qualitative data on their experiences of maternity care during COVID-19. The electronic databases of MEDLINE, CINAHL, EMBASE, PsycINFO and the Cochrane COVID study register were systematically searched from 01 Jan 2020 to 13 June 2021. The methodological quality of the included studies was appraised using a modified version of the quality assessment tool, based on 12-criteria, designed by the Evidence for Policy and Practice Information coordinating Centre (EPPI-Centre). Data were extracted by two reviewers independently and synthesised using the Thomas and Harden framework. Confidence in the findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual). RESULTS: Fifty records relating to 48 studies, involving 9,348 women and 2,538 maternity care providers, were included in the QES. The methodological quality of the studies varied from four studies meeting all 12 quality criteria to two studies meeting one quality criterion only. The synthesis revealed eight prominent themes. Five of these reflected women's experiences: 1) Altered maternity care (women), 2) COVID-related restrictions, 3) Infection prevention and risk, 4) 'the lived reality' - navigating support systems, and 5) Interactions with maternity services. Three themes reflected maternity care providers' experiences: 6) Altered maternity care (providers), 7) Professional and personal impact, and 8) Broader structural impact. Confidence in the findings was high or moderate. CONCLUSION: Although some positive experiences were identified, overall, this QES reveals that maternity care during COVID-19 was negatively experienced by both women and maternity care providers. The pandemic and associated changes evoked an array of emotive states for both populations, many of which have the potential to impact on future health and wellbeing. Resource and care planning to mitigate medium- and longer-term adverse sequelae are required. PROSPERO REGISTRATION: CRD42021232684.
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COVID-19 , Servicios de Salud Materna , Obstetricia , Femenino , Humanos , Embarazo , Investigación CualitativaRESUMEN
OBJECTIVE: Increased demand for quality primary care and value-based payment has prompted interest in implementing primary care teams. Evidence-based recommendations for implementing teams will be critical to successful PA participation. This study sought to describe how primary care providers (PCPs) define team membership boundaries and coordinate tasks. METHODS: This mixed-methods study included 28 PCPs from a primary care network. We analyzed survey data using descriptive statistics and interview data using content analysis. RESULTS: Ninety-six percent of PCPs reported team membership. Team models fell into one of five categories. The predominant coordination mechanism differed by whether coordination was required in a visit or between visits. CONCLUSIONS: Team-based primary care is a strategy for improving access to quality primary care. Most PCPs define team membership based on within-visit task interdependencies. Our findings suggest that team-based interventions can focus on clarifying team membership, increasing interaction between clinicians, and enhancing the electronic health record to facilitate between-visit coordination.
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Registros Electrónicos de Salud , Atención Primaria de Salud , Personal de Salud , Humanos , Grupo de Atención al Paciente , Calidad de la Atención de Salud , Encuestas y CuestionariosRESUMEN
Emerging evidence suggests mild traumatic brain injury related headache (MTBI-HA) is a form of neuropathic pain state. Previous supraspinal mechanistic studies indicate patients with MTBI-HA demonstrate a dissociative state with diminished levels of supraspinal prefrontal pain modulatory functions and enhanced supraspinal sensory response to pain in comparison to healthy controls. However, the relationship between supraspinal pain modulatory functional deficit and severity of MTBI-HA is largely unknown. Understanding this relationship may provide enhanced levels of insight about MTBI-HA and facilitate the development of treatments. This study assessed pain related supraspinal resting states among MTBI-HA patients with various headache intensity phenotypes with comparisons to controls via functional magnetic resonance imaging (fMRI). Resting state fMRI data was analyzed with self-organizing-group-independent-component-analysis in three MTBI-HA intensity groups (mild, moderate, and severe) and one control group (n = 16 per group) within a pre-defined supraspinal pain network based on prior studies. In the mild-headache group, significant increases in supraspinal function were observed in the right premotor cortex (T = 3.53, p < 0.001) and the left premotor cortex (T = 3.99, p < 0.0001) when compared to the control group. In the moderate-headache group, a significant (T = -3.05, p < 0.01) decrease in resting state activity was observed in the left superior parietal cortex when compared to the mild-headache group. In the severe-headache group, significant decreases in resting state supraspinal activities in the right insula (T = -3.46, p < 0.001), right premotor cortex (T = -3.30, p < 0.01), left premotor cortex (T = -3.84, p < 0.001), and left parietal cortex (T = -3.94, p < 0.0001), and an increase in activity in the right secondary somatosensory cortex (T = 4.05, p < 0.0001) were observed when compared to the moderate-headache group. The results of the study suggest that the increase in MTBI-HA severity may be associated with an imbalance in the supraspinal pain network with decline in supraspinal pain modulatory function and enhancement of sensory/pain decoding.