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1.
Am J Perinatol ; 40(8): 893-897, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-34282573

RESUMO

OBJECTIVE: Antibiotic stewardship should be an essential component of neonatology training as neonatal intensive care units (NICU) have unique stewardship needs. Our aim was to assess neonatology fellowship trainees' knowledge, attitudes, and perceptions about antibiotic stewardship to inform sustainable curriculum development. STUDY DESIGN: We distributed an electronic survey to neonatology fellows in the United States over 4 months (January-April 2018) via Accreditation Council for Graduate Medical Education program directors. RESULTS: Of 99 programs in the United States with an estimated 700 fellows, 159 (23%) fellows from 52 training programs (53%) responded to the survey and 139 (87%) provided analyzed responses. Majority of respondents were training in southern (59; 42%) and northeastern (43; 31%) regions and were equally spread across all 3 years of training. One hundred (72%) respondents reported an antibiotic stewardship program (ASP) in their institution. While 86% (120/139) were able to identify the components of an ASP, 59% (82/139) either did not or were unsure if they had received antibiotic stewardship training during fellowship.Furthermore, while answering case studies, 124 (89%) respondents identified the optimal antibiotic for methicillin susceptible Staphylococcus aureus (MSSA) infection and 69 (50%) respondents chose appropriate empiric antibiotics for neonatal meningitis. Notably, fellowship training year was not significantly related to the proportion of incorrect knowledge responses (p = 0.40). Most survey respondents (81; 59%) identified small group sessions as the most useful teaching format, while others chose audit and feedback of individual prescribing behavior (52; 38%) and didactic lectures (52; 38%). Finally, ninety-five (69%) respondents preferred trainee-led ASP interventions targeting focal areas such as antifungal and surgical prophylaxis. CONCLUSION: Antibiotic stewardship is a critical part of neonatology training. Neonatology fellows report variation in access to ASP during their training. Fellows prefer dedicated trainee-led interventions and stewardship curriculum taught within small group settings to promote targeted NICU ASP. KEY POINTS: · Most neonatology programs expose trainees to internal or external antibiotic stewardship programs.. · Over half of fellow trainees are unsure about receiving targeted antibiotic stewardship training.. · Most neonatology fellows prefer a trainee-led antibiotic stewardship intervention..


Assuntos
Gestão de Antimicrobianos , Neonatologia , Recém-Nascido , Humanos , Estados Unidos , Conhecimentos, Atitudes e Prática em Saúde , Currículo , Educação de Pós-Graduação em Medicina , Inquéritos e Questionários , Bolsas de Estudo
2.
J Pediatr ; 246: 56-63.e3, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35430250

RESUMO

OBJECTIVE: To evaluate the cost-utility of catheterization-obligate treatment in preterm infants with pulmonary hypertension, as compared with empiric initiation of sildenafil based on echocardiographic findings alone. STUDY DESIGN: A Markov state transition model was constructed to simulate the clinical scenario of a preterm infant with echocardiographic evidence of pulmonary hypertension associated with bronchopulmonary dysplasia (BPD) and without congenital heart disease under consideration for the initiation of pulmonary vasodilator therapy via one of two modeled treatment strategies-empiric or catheterization-obligate. Transitional probabilities, costs and utilities were extracted from the literature. Forecast quality-adjusted life-years was the metric for strategy effectiveness. Sensitivity analyses for each variable were performed. A 1000-patient Monte Carlo microsimulation was used to test the durability of our findings. RESULTS: The catheterization-obligate strategy resulted in an increased cost of $10 778 and 0.02 fewer quality-adjusted life-years compared with the empiric treatment strategy. Empiric treatment remained the more cost-effective paradigm across all scenarios modeled through one-way sensitivity analyses and the Monte Carlo microsimulation (cost-effective in 98% of cases). CONCLUSIONS: Empiric treatment with sildenafil in infants with pulmonary hypertension associated with BPD is a superior strategy with both decreased costs and increased effectiveness when compared with catheterization-obligate treatment. These findings suggest that foregoing catheterization before the initiation of sildenafil is a reasonable strategy in preterm infants with uncomplicated pulmonary hypertension associated with BPD.


Assuntos
Displasia Broncopulmonar , Hipertensão Pulmonar , Displasia Broncopulmonar/complicações , Displasia Broncopulmonar/terapia , Cateterismo Cardíaco/efeitos adversos , Humanos , Hipertensão Pulmonar/tratamento farmacológico , Hipertensão Pulmonar/etiologia , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Citrato de Sildenafila
3.
Hum Reprod ; 37(11): 2690-2699, 2022 10 31.
Artigo em Inglês | MEDLINE | ID: mdl-36149255

RESUMO

STUDY QUESTION: Do women with polycystic ovary syndrome (PCOS) have a greater risk of adverse pregnancy complications (gestational diabetes, preeclampsia, cesarean section, placental abnormalities) and neonatal outcomes (preterm birth, small for gestational age, prolonged delivery hospitalization) compared to women without a PCOS diagnosis and does this risk vary by BMI, subfertility and fertility treatment utilization? SUMMARY ANSWER: Deliveries to women with a history of PCOS were at greater risk of complications associated with cardiometabolic function, including gestational diabetes and preeclampsia, as well as preterm birth and prolonged length of delivery hospitalization. WHAT IS KNOWN ALREADY: Prior research has suggested that women with PCOS may be at increased risk of adverse pregnancy outcomes. However, findings have been inconsistent possibly due to lack of consistent adjustment for confounding factors, small samples size and other sources of bias. STUDY DESIGN, SIZE, DURATION: Massachusetts deliveries among women ≥18 years old during 2013-2017 from state vital records linked to hospital discharges, observational stays and emergency department visits were linked to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) and the Massachusetts All-Payers Claims Database (APCD). PARTICIPANTS/MATERIALS, SETTING, METHODS: PCOS was identified by ICD9 and ICD10 codes in APCD prior to index delivery. Relative risks (RRs) and 95% CI for pregnancy and delivery complications were modeled using generalized estimating equations with a log link and a Poisson distribution to take multiple cycles into account and were adjusted a priori for maternal age, BMI, race/ethnicity, education, plurality, birth year, chronic hypertension and chronic diabetes. Tests for homogeneity investigated differences between maternal pre-pregnancy BMI categories (<30, ≥30, <25 and ≥25 kg/m2) and between non-infertile deliveries and deliveries that used ART or had a history of subfertility (defined by birth certificates, SART CORS records, APCD or hospital records). MAIN RESULTS AND THE ROLE OF CHANCE: Among 91 825 deliveries, 3.9% had a history of PCOS. Women with a history of PCOS had a 51% greater risk of gestational diabetes (CI: 1.38-1.65) and a 25% greater risk of preeclampsia (CI: 1.15-1.35) compared to women without a diagnosis of PCOS. Neonates born to women with a history of PCOS were more likely to be born preterm (RR: 1.17, CI: 1.06-1.29) and more likely to have a prolonged delivery hospitalization after additionally adjusting for gestational age (RR: 1.23, CI: 1.09-1.40) compared to those of women without a diagnosis of PCOS. The risk for gestational diabetes for women with PCOS was greater among women with a pre-pregnancy BMI <30 kg/m2. LIMITATIONS, REASONS FOR CAUTION: PCOS was defined by ICD documentation prior to delivery so there may be women with undiagnosed PCOS or PCOS diagnosed after delivery included in the unexposed group. The study population is limited to deliveries within Massachusetts among most private insurance payers and inpatient or observational hospitalization in Massachusetts during the follow-up window, therefore there may be diagnoses and or deliveries outside of the state or outside of our sample that were not captured. WIDER IMPLICATIONS OF THE FINDINGS: In this population-based study, women with a history of PCOS were at greater risk of pregnancy complications associated with cardiometabolic function and preterm birth. Obstetricians should be aware of patients' PCOS status and closely monitor for potential pregnancy complications to improve maternal and infant perinatal health outcomes. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by the NIH (R01HD067270). S.A.M. receives grant funding from NIH, AbbVie and the Marriot Family Foundation; payment/honoraria from the University of British Columbia, World Endometriosis Research Foundation and Huilun Shanghai; travel support for attending meetings for ESHRE 2019, IASP 2019, National Endometriosis Network UK meeting 2019; SRI 2022, ESHRE 2022; participates on the data safety monitoring board/advisory board for AbbVie, Roche, Frontiers in Reproductive Health; and has a leadership role in the Society for Women's Health Research, World Endometriosis Research Foundation, World Endometriosis Society, American Society for Reproductive Medicine and ESHRE. The other authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.


Assuntos
Doenças Cardiovasculares , Diabetes Gestacional , Endometriose , Infertilidade , Síndrome do Ovário Policístico , Pré-Eclâmpsia , Complicações na Gravidez , Nascimento Prematuro , Humanos , Feminino , Recém-Nascido , Gravidez , Estados Unidos , Adolescente , Síndrome do Ovário Policístico/complicações , Nascimento Prematuro/epidemiologia , Cesárea , Endometriose/complicações , Placenta , China , Resultado da Gravidez , Infertilidade/complicações , Sistema de Registros , Doenças Cardiovasculares/complicações
4.
Am J Obstet Gynecol ; 226(6): 829.e1-829.e14, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35108504

RESUMO

BACKGROUND: Endometriosis and uterine fibroids are common gynecologic conditions associated with a greater risk for infertility. Previous research has suggested that these conditions are associated with adverse pregnancy outcomes, potentially because of increased utilization of fertility treatments. OBJECTIVE: Our objective was to investigate whether women with a history of endometriosis or fibroids had a greater risk for adverse pregnancy outcomes and whether this risk varied by infertility history and fertility treatment utilization. STUDY DESIGN: Deliveries (2013-2017) recorded in Massachusetts' vital records were linked to assisted reproductive technology data, hospital stays, and all-payer claims database. We identified endometriosis and fibroids diagnoses via the all-payer claims database before index delivery. Adjusted relative risks for pregnancy complications were modeled using generalized estimating equations with a log link and Poisson distribution. The influence of subfertility or infertility and assisted reproductive technology was also investigated. RESULTS: Among 91,825 deliveries, 1560 women had endometriosis and 4212 had fibroids. Approximately 30% of women with endometriosis and 26% of women with fibroids experienced subfertility or infertility without utilizing assisted reproductive technology, and 34% of women with endometriosis and 21% of women with fibroids utilized assisted reproductive technology for the index delivery. Women with a history of endometriosis or fibroids were at a greater risk for pregnancy-induced hypertension, preeclampsia, or eclampsia (endometriosis relative risk, 1.17; fibroids relative risk, 1.08), placental abnormalities (endometriosis relative risk, 1.65; fibroids relative risk, 1.38), and cesarean delivery (endometriosis relative risk, 1.22; fibroids relative risk, 1.17) than women with no history of those conditions. Neonates born to women with a history of endometriosis or fibroids were also at a greater risk for preterm birth (endometriosis relative risk, 1.24; fibroids relative risk, 1.17). Associations between fibroids and low birthweight varied by fertility status or assisted reproductive technology (P homogeneity=.01) and were stronger among noninfertile women. CONCLUSION: Endometriosis or fibroids increased the risk for adverse pregnancy outcomes, possibly warranting differential screening or treatment.


Assuntos
Endometriose , Infertilidade , Leiomioma , Nascimento Prematuro , Endometriose/complicações , Endometriose/epidemiologia , Feminino , Humanos , Recém-Nascido , Leiomioma/epidemiologia , Massachusetts/epidemiologia , Placenta , Gravidez , Resultado da Gravidez/epidemiologia , Gravidez Múltipla , Nascimento Prematuro/epidemiologia , Sistema de Registros , Técnicas de Reprodução Assistida
5.
Am J Perinatol ; 38(10): 1023-1030, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-32052399

RESUMO

OBJECTIVE: The aim of this study is to examine presence trends for parents and family members during an infant's Neonatal Intensive Care Unit (NICU) hospitalization. STUDY DESIGN: We conducted a review of 386 infants hospitalized in a Level IV NICU in the Northwestern United States between June 2013 and April 2014 to quantitatively examine presence trends. RESULTS: Infants were visited by multiple family members. The father was the most common first family member at the bedside after admission. Parents were present over half of the days their infants were in the NICU (medians: mothers 75% and fathers 59%), but a relatively small percentage of the total hospitalization time (medians: 10% mothers and 5% fathers). Fathers', grandmothers', and grandfathers' presence with their infants in the NICU were negatively correlated with infants' total length of stay in the NICU. This finding was not replicated for mothers. Female family members were present in the NICU more than male family members. CONCLUSION: Parents are present a small percent of the time their infants are hospitalized in the NICU. NICU based methods to improve family presence may lead to improved patient and family centered care. KEY POINTS: · Mothers are present 10% of total NICU time.. · Fathers are present 5% of total NICU time.. · Fathers' presence was associated with a shorter stay.. · Grandparents' presence was associated with a shorter stay.. · Females were present significantly more than males..


Assuntos
Família , Unidades de Terapia Intensiva Neonatal , Assistência Centrada no Paciente , Pai , Feminino , Humanos , Recém-Nascido , Tempo de Internação/estatística & dados numéricos , Masculino , Mães
6.
J Assist Reprod Genet ; 38(1): 211-218, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33185819

RESUMO

PURPOSE: Among infants following ART-treated, subfertile, and fertile deliveries to determine (1) the presence and magnitude of sex differences in health outcomes and (2) whether the presence of sex differences varied among maternal fertility groups. METHODS: Retrospective cohort analysis of infants born in Massachusetts (MA) in 2004-2013 who were conceived by ART. The Society for Assisted Reproductive Technology Clinic Outcome Reporting System was linked to the Pregnancy to Early Life Longitudinal data system, which links birth certificates to hospital discharge records for MA mothers and infants. Included were singletons born via ART-treated, subfertile, and fertile deliveries. Multivariable logistic regression was used to model the association between infant sex and health outcomes, controlling for maternal demographic and health characteristics. RESULTS: A total of 16,034 ART-treated, 13,277 subfertile, and 620,375 fertile singleton live births were included. For all three groups, males had greater odds of being preterm (AOR range 1.15-1.2), having birth defects (AOR range 1.31-1.71), experiencing respiratory (AOR range 1.33-1.35) and neurologic (AOR range 1.24-1.3) conditions, and prolonged hospital stay (AOR range 1.19-1.25) compared to females. The interaction between maternal fertility group and infant sex for all infant outcomes was nonsignificant, denoting that the presence of sex differences among fertile, subfertile, and ART groups did not vary. CONCLUSION: Sex differences in birth outcomes of infants following ART-treated, subfertile, and fertile deliveries exist but the magnitude of these differences does not vary among these maternal fertility groups.


Assuntos
Fertilidade/fisiologia , Saúde do Lactente/estatística & dados numéricos , Infertilidade/fisiopatologia , Técnicas de Reprodução Assistida/efeitos adversos , Adulto , Feminino , Fertilidade/genética , Humanos , Recém-Nascido de Baixo Peso/fisiologia , Recém-Nascido , Recém-Nascido Prematuro/fisiologia , Infertilidade/genética , Masculino , Gravidez , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/fisiopatologia , Estudos Retrospectivos , Caracteres Sexuais
7.
J Assist Reprod Genet ; 38(5): 1089-1100, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33606146

RESUMO

PURPOSE: We previously developed a subfertile comparison group with which to compare outcomes of assisted reproductive technology (ART) treatment. In this study, we evaluated whether insurance claims data in the Massachusetts All Payers Claims Database (APCD) defined a more appropriate comparison group. METHODS: We used Massachusetts vital records of women who delivered between 2013 and 2017 on whom APCD data were available. ART deliveries were those linked to a national ART database. Deliveries were subfertile if fertility treatment was marked on the birth certificate, had prior hospitalization with ICD code for infertility, or prior fertility treatment. An infertile group included women with an APCD outpatient or inpatient ICD 9/10 infertility code prior to delivery. Fertile deliveries were none of the above. Demographics, health risks, and obstetric outcomes were compared among groups. Multivariable generalized estimating equations were used to calculate adjusted relative risk (aRR) and 95% confidence intervals (CI). RESULTS: There were 70,726 fertile, 4,763 subfertile, 11,970 infertile, and 7,689 ART-treated deliveries. Only 3,297 deliveries were identified as both subfertile and infertile. Both subfertile and infertile were older, and had more education, chronic hypertension, and diabetes than the fertile group and less than the ART-treated group. Prematurity (aRR = 1.15-1.17) and birthweight (aRR = 1.10-1.21) were increased in all groups compared with the fertile group. CONCLUSION: Although the APCD allowed identification of more women than the previously defined subfertile categorization and allowed us to remove previously unidentified infertile women from the fertile group, it is not clear that it offered a clinically significantly improved comparison group.


Assuntos
Fertilidade/fisiologia , Infertilidade Feminina/epidemiologia , Nascimento Prematuro/epidemiologia , Técnicas de Reprodução Assistida/tendências , Adulto , Grupos Controle , Feminino , Fertilidade/genética , Humanos , Recém-Nascido de Baixo Peso/metabolismo , Recém-Nascido , Idade Materna , Pacientes Ambulatoriais , Gravidez
8.
Value Health ; 23(5): 559-565, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32389220

RESUMO

OBJECTIVES: The challenges of understanding how interventions influence follow-up medical care are magnified during genomic testing because few patients have received it to date and because the scope of information it provides is complex and often unexpected. We tested a novel strategy for quantifying downstream healthcare utilization after genomic testing to more comprehensively and efficiently identify related services. We also evaluated the effectiveness of different methods for collecting these data. METHODS: We developed a risk-based approach for a trial of newborn genomic sequencing in which we defined primary conditions based on existing diagnoses and family histories of disease and defined secondary conditions based on unexpected findings. We then created patient-specific lists of services associated with managing primary and secondary conditions. Services were quantified based on medical record reviews, surveys, and telephone check-ins with parents. RESULTS: By focusing on services that genomic testing would most likely influence in the short-term, we reduced the number of services in our analyses by more than 90% compared with analyses of all observed services. We also identified the same services that were ordered in response to unexpected findings as were identified during expert review and by confirming whether recommendations were completed. Data also showed that quantifying healthcare utilization with surveys and telephone check-ins alone would have missed the majority of attributable services. CONCLUSIONS: Our risk-based strategy provides an improved approach for assessing the short-term impact of genomic testing and other interventions on healthcare utilization while conforming as much as possible to existing best-practice recommendations.


Assuntos
Testes Genéticos , Genômica , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Feminino , Humanos , Lactente , Estudos Longitudinais , Masculino , Pais/psicologia , Fatores de Risco , Inquéritos e Questionários , Telefone
9.
Am J Perinatol ; 37(1): 1-7, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31370065

RESUMO

OBJECTIVE: Our cost-effectiveness analysis investigated rooming-in versus not rooming-in to determine optimal management of neonates with neonatal opioid withdrawal (NOW). STUDY DESIGN: A decision-analytic model was constructed using TreeAge to compare rooming-in versus not rooming-in in a theoretical cohort of 23,200 newborns, the estimated annual number affected by NOW in the United States. Additional considerations included the effect of breast milk versus formula milk in evaluating the need for pharmacotherapy. Primary outcomes were needed for pharmacotherapy and neurodevelopment. We assumed a societal perspective in evaluating costs and maternal-neonatal quality-adjusted life years (QALYs) using a willingness-to-pay threshold of $100,000/QALY. Model inputs were derived from literature and varied in sensitivity analyses. RESULTS: Rooming-in resulted in fewer neonates requiring pharmacotherapy when compared with not rooming-in. The rooming-in group had more neonates with intact/mild neurodevelopmental impairment and fewer cases of moderate to severe impairment. Rooming-in resulted in cost savings of $509,652,728 and 12,333 additional QALYs per annual cohort. When the risk ratio of need for pharmacotherapy in rooming-in was varied across a clinically plausible range, rooming-in remained the cost-effective strategy. CONCLUSION: Maternal rooming-in with newborns affected by NOW leads to reduced costs and increased effectiveness. Management strategies should optimize nonpharmacological interventions as first-line treatment.


Assuntos
Aleitamento Materno/economia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Síndrome de Abstinência Neonatal/economia , Berçários Hospitalares/economia , Alojamento Conjunto/economia , Estudos de Coortes , Redução de Custos , Feminino , Humanos , Incidência , Recém-Nascido , Modelos Econômicos , Síndrome de Abstinência Neonatal/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Estados Unidos/epidemiologia
10.
J Pediatr ; 205: 272-276.e1, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30291023

RESUMO

Up to 20% of newborn infants retro-transferred to a lower level of care require readmission to a higher-level facility. In this study, we developed and validated a prediction rule (The Rule for Elective Transfer between Units for Recovering Neonates [RETURN]) to identify clinical characteristics of infants at risk for failing retro-transfer.


Assuntos
Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Berçários Hospitalares/estatística & dados numéricos , Transferência de Pacientes/normas , Encaminhamento e Consulta , Feminino , Seguimentos , Humanos , Recém-Nascido , Masculino , Prognóstico , Curva ROC , Estudos Retrospectivos
11.
Am J Perinatol ; 36(6): 632-640, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30292175

RESUMO

OBJECTIVE: To test the hypothesis that maternal height is associated with adverse perinatal outcomes, controlling for and stratified by maternal body mass index (BMI). STUDY DESIGN: This was a retrospective cohort study of all births in California between 2007 and 2010 (n = 1,775,984). Maternal height was categorized into quintiles, with lowest quintile (≤20%) representing shorter stature and the uppermost quintile (≥80%) representing taller stature. Outcomes included gestational diabetes mellitus (GDM), preeclampsia, cesarean, preterm birth (PTB), macrosomia, and low birth weight (LBW). We calculated height/outcome associations among BMI categories, and BMI/outcome associations among height categories, using various multivariable logistic regression models. RESULTS: Taller women were less likely to have GDM, nulliparous cesarean, PTB, and LBW; these associations were similar across maternal BMI categories and persisted after multivariable adjustment. In contrast, when stratified by maternal height, the associations between maternal BMI and birth outcomes varied by specific outcomes, for example, the association between morbid obesity (compared with normal or overweight) and the risk of GDM was weaker among shorter women (adjusted odds ratio [aOR], 95% confidence interval [CI]: 3.48, 3.28-3.69) than taller women (aOR, 95% CI: 4.42, 4.19-4.66). CONCLUSION: Maternal height is strongly associated with altered perinatal risk even after accounting for variations in complications by BMI.


Assuntos
Estatura , Índice de Massa Corporal , Obesidade Materna , Resultado da Gravidez , Adulto , Cesárea/estatística & dados numéricos , Diabetes Gestacional/epidemiologia , Feminino , Macrossomia Fetal/epidemiologia , Humanos , Recém-Nascido de Baixo Peso , Pré-Eclâmpsia/epidemiologia , Gravidez , Nascimento Prematuro/epidemiologia , Estudos Retrospectivos
12.
Genet Med ; 20(12): 1544-1553, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29565423

RESUMO

PURPOSE: Great uncertainty exists about the costs associated with whole-genome sequencing (WGS). METHODS: One hundred cardiology patients with cardiomyopathy diagnoses and 100 ostensibly healthy primary care patients were randomized to receive a family-history report alone or with a WGS report. Cardiology patients also reviewed prior genetic test results. WGS costs were estimated by tracking resource use and staff time. Downstream costs were estimated by identifying services in administrative data, medical records, and patient surveys for 6 months. RESULTS: The incremental cost per patient of WGS testing was $5,098 in cardiology settings and $5,073 in primary care settings compared with family history alone. Mean 6-month downstream costs did not differ statistically between the control and WGS arms in either setting (cardiology: difference = -$1,560, 95% confidence interval -$7,558 to $3,866, p = 0.36; primary care: difference = $681, 95% confidence interval -$884 to $2,171, p = 0.70). Scenario analyses showed the cost reduction of omitting or limiting the types of secondary findings was less than $69 and $182 per patient in cardiology and primary care, respectively. CONCLUSION: Short-term costs of WGS were driven by the costs of sequencing and interpretation rather than downstream health care. Disclosing additional types of secondary findings has a limited cost impact following disclosure.


Assuntos
Análise Custo-Benefício/economia , Testes Genéticos/economia , Atenção Primária à Saúde/economia , Sequenciamento Completo do Genoma/economia , Cardiologia/economia , Cardiologia/tendências , Feminino , Testes Genéticos/tendências , Humanos , Masculino , Projetos Piloto
13.
Value Health ; 21(9): 1054-1061, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30224109

RESUMO

OBJECTIVE: To summarize lessons learned while analyzing the costs of integrating whole genome sequencing into the care of cardiology and primary care patients in the MedSeq Project by conducting the first randomized controlled trial of whole genome sequencing in general and specialty medicine. METHODS: Case study that describes key methodological and data challenges that were encountered or are likely to emerge in future work, describes the pros and cons of approaches considered by the study team, and summarizes the solutions that were implemented. RESULTS: Major methodological challenges included defining whole genome sequencing, structuring an appropriate comparator, measuring downstream costs, and examining clinical outcomes. Discussions about solutions addressed conceptual and practical issues that arose because of definitions and analyses around the cost of genomic sequencing in trial-based studies. CONCLUSIONS: The MedSeq Project provides an instructive example of how to conduct a cost analysis of whole genome sequencing that feasibly incorporates best practices while being sensitive to the varied applications and diversity of results it may produce. Findings provide guidance for researchers to consider when conducting or analyzing economic analyses of whole genome sequencing and other next-generation sequencing tests, particularly regarding costs.


Assuntos
Genômica/métodos , Sequenciamento Completo do Genoma/economia , Serviço Hospitalar de Cardiologia/normas , Análise Custo-Benefício , Genômica/instrumentação , Genômica/tendências , Humanos , Atenção Primária à Saúde/normas , Sequenciamento Completo do Genoma/normas
14.
Ann Intern Med ; 167(3): 159-169, 2017 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-28654958

RESUMO

Background: Whole-genome sequencing (WGS) in asymptomatic adults might prevent disease but increase health care use without clinical value. Objective: To describe the effect on clinical care and outcomes of adding WGS to standardized family history assessment in primary care. Design: Pilot randomized trial. (ClinicalTrials.gov: NCT01736566). Setting: Academic primary care practices. Participants: 9 primary care physicians (PCPs) and 100 generally healthy patients recruited at ages 40 to 65 years. Intervention: Patients were randomly assigned to receive a family history report alone (FH group) or in combination with an interpreted WGS report (FH + WGS group), which included monogenic disease risk (MDR) results (associated with Mendelian disorders), carrier variants, pharmacogenomic associations, and polygenic risk estimates for cardiometabolic traits. Each patient met with his or her PCP to discuss the report. Measurements: Clinical outcomes and health care use through 6 months were obtained from medical records and audio-recorded discussions between PCPs and patients. Patients' health behavior changes were surveyed 6 months after receiving results. A panel of clinician-geneticists rated the appropriateness of how PCPs managed MDR results. Results: Mean age was 55 years; 58% of patients were female. Eleven FH + WGS patients (22% [95% CI, 12% to 36%]) had new MDR results. Only 2 (4% [CI, 0.01% to 15%]) had evidence of the phenotypes predicted by an MDR result (fundus albipunctatus due to RDH5 and variegate porphyria due to PPOX). Primary care physicians recommended new clinical actions for 16% (CI, 8% to 30%) of FH patients and 34% (CI, 22% to 49%) of FH + WGS patients. Thirty percent (CI, 17% to 45%) and 41% (CI, 27% to 56%) of FH and FH + WGS patients, respectively, reported making a health behavior change after 6 months. Geneticists rated PCP management of 8 MDR results (73% [CI, 39% to 99%]) as appropriate and 2 results (18% [CI, 3% to 52%]) as inappropriate. Limitation: Limited sample size and ancestral and socioeconomic diversity. Conclusion: Adding WGS to primary care reveals new molecular findings of uncertain clinical utility. Nongeneticist providers may be able to manage WGS results appropriately, but WGS may prompt additional clinical actions of unclear value. Primary Funding Source: National Institutes of Health.


Assuntos
Anamnese , Medidas de Resultados Relatados pelo Paciente , Atenção Primária à Saúde/métodos , Sequenciamento Completo do Genoma , Adulto , Idoso , Doenças Assintomáticas , Feminino , Comportamentos Relacionados com a Saúde , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Projetos Piloto , Encaminhamento e Consulta/economia , Medição de Risco
15.
J Assist Reprod Genet ; 35(9): 1585-1593, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29926374

RESUMO

PURPOSE: To determine whether differences in birth outcomes among assisted reproductive technology (ART)-treated, subfertile, and fertile women exist in primiparous women with, singleton, vaginal deliveries. METHODS: Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) data were linked to Massachusetts vital records and hospital discharges for deliveries between July 2004 and December 2010. Primiparous women with in-state vaginal deliveries, adequate prenatal care, and singleton birth at ≥ 20 weeks (n = 117,779) were classified as ART-treated (linked to ART data from SART CORS, n = 3138); subfertile (not ART-treated but with indicators of subfertility, n = 1507); or fertile (neither ART-treated nor subfertile, n = 113,134). Outcomes of prematurity (< 37 weeks), low birthweight (< 2500 g), perinatal death (death at ≥ 20 weeks to ≤ 7 days), and maternal prolonged length of hospital stay (LOS > 3 days) were compared using multivariable logistic regression. RESULTS: Compared to fertile, higher odds were found for prematurity among ART-treated (adjusted odds ratio [AOR] 1.40, 95% confidence interval [CI] 1.25-1.50) and subfertile (AOR 1.25, 95% CI 1.03-1.50) women, low birthweight among ART-treated (AOR 1.41, 95% CI 1.23-1.62) and subfertile (AOR 1.40, 95% CI 1.15-1.71) women, perinatal death among subfertile (AOR 2.64, 95% CI 1.72-4.05), and prolonged LOS among ART-treated (AOR 1.33, 95% CI 1.19-1.48) women. Differences remained despite stratification by young age and absence of pregnancy/delivery complications. CONCLUSIONS: Greater odds of prematurity and low birthweight in ART-treated and subfertile, and perinatal death in subfertile deliveries are evident among singleton vaginal deliveries. The data suggest that even low-risk pregnancies to ART-treated and subfertile women be managed for adverse outcomes.


Assuntos
Fertilidade/fisiologia , Paridade/fisiologia , Complicações na Gravidez/epidemiologia , Técnicas de Reprodução Assistida/tendências , Adulto , Feminino , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Infertilidade/epidemiologia , Infertilidade/patologia , Gravidez , Resultado da Gravidez , Nascimento Prematuro/epidemiologia , Transferência de Embrião Único
16.
J Perinatol ; 44(2): 224-230, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37805592

RESUMO

OBJECTIVE: To examine association of costs with quality of care and patient outcome across hospitals in California. METHODS: Retrospective study of very low birth weight (VLBW) births from 2014-2018 linking birth certificate, hospital discharge records and clinical data. Quality was measured using the Baby-MONITOR score. Clinical outcome was measured using survival without major morbidity (SWMM). Hierarchical generalized linear models, adjusting for clinical factors, were used to estimate risk-adjusted measures of costs, quality, and outcome for each hospital. Association between these measures was evaluated using Pearson correlation coefficient. RESULTS: In total, 15,415 infants from 104 NICUs were included. Risk-adjusted Baby-MONITOR score, SWMM rate, and costs varied substantially. There was no correlation between risk-adjusted cost and Baby-MONITOR score (r = 0, p = 0.998). Correlation between risk-adjusted cost and SWMM rate was inverse and not significant (r = -0.07, p = 0.48). CONCLUSIONS: With the metrics used, we found no correlation between cost, quality, and outcomes in the care of VLBW infants.


Assuntos
Recém-Nascido de muito Baixo Peso , Unidades de Terapia Intensiva Neonatal , Recém-Nascido , Lactente , Humanos , Estudos Retrospectivos , California , Fatores de Risco , Peso ao Nascer
19.
Am J Perinatol ; 30(8): 631-42, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23283805

RESUMO

OBJECTIVE: A previous multisite, randomized, controlled trial of peer support compared with usual care for prevention of postpartum depression demonstrated a reduction in depression symptoms at 12 weeks postbirth. Our objective was to determine the cost-effectiveness of this intervention. STUDY DESIGN: Prospectively planned economic evaluation alongside the clinical trial to determine the cost per case of postpartum depression averted, using individual patient data (n = 610) and societal perspective. All costs were expressed in 2011 Canadian dollars. RESULTS: The mean cost per woman was $4,497 in the peer support group and $3,380 in the usual care group (difference of $1,117, p < 0.0001). There was a 95% probability that the program would cost less than $20,196 per case of postpartum depression averted. CONCLUSIONS: Although this is a volunteer-based program, it results in a net cost to the health care system and society. However, this cost is within the range for other accepted interventions for this population.


Assuntos
Depressão Pós-Parto/prevenção & controle , Serviços Preventivos de Saúde/economia , Apoio Social , Telemedicina/métodos , Canadá , Análise Custo-Benefício , Feminino , Humanos , Grupo Associado , Gravidez , Estudos Prospectivos , Resultado do Tratamento , Voluntários
20.
Health Equity ; 7(1): 466-476, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37731785

RESUMO

Background: Racial inequities in maternal health outcomes, the result of systemic racism and social determinants of health, require maternity care systems to implement interventions that reduce disparities. One such approach may be support from a community doula, a health worker who provides emotional support, peer education, navigation, and advocacy for pregnant, birthing, and postpartum people who share similar racial identities, cultural backgrounds, and/or lived experiences. While community support during birth has a long tradition within communities of Black Indigenous and People of Color (BIPOC), the reframing of community doula support as a social intervention that reduces disparities in clinical outcomes is recent. Methods: We conducted a pragmatic randomized trial at an urban safety net hospital, comparing standard maternity care with standard care plus enhanced community doula support. We tested the effectiveness of a community doula program embedded in a safety net hospital in improving birth outcomes and explored the association between community doula support and health equity. Participants were nulliparous, insured by publicly funded health plans, and had lower risk pregnancies. The primary outcome was cesarean birth. Secondary outcomes included preterm birth and breastfeeding outcomes. Exploratory subgroup analysis was conducted by race-ethnicity. Results: Three hundred sixty-seven participants were included in the primary analysis. In the intent-to-treat analysis, outcomes were similar between groups. There was a trend toward increased breastfeeding initiation (p=0.08). There was a statistically nonsignificant 12% absolute reduction in cesarean birth and 11.5% increase in exclusive breastfeeding during delivery hospitalization among Black non-Hispanic participants. Discussion: While outcomes for the study sample were similar between randomization groups, health outcomes were improved for Black birthing people in cesarean and breastfeeding rates. Conclusion: This study demonstrates the need for larger studies of community doula support for Black birthing people. Clinicaltrials.gov ID: NCT02550730.

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