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Biomedical subjects

Marc B Rosenman

Publications and source records attributed to Marc B Rosenman.

10 recordsLinked to original sources

Genotype-Guided Antidepressant Prescribing for Patients With Depression: A Randomized Clinical Trial.

IMPORTANCE: The effectiveness of pharmacogenetics to guide prescribing of selective serotonin reuptake inhibitors (SSRIs) for depression remains unclear, despite the well-established association between SSRI pharmacokinetics and genetic variation. OBJECTIVE: To determine whether pharmacogenetic-guided prescribing of SSRIs improves treatment response in patients with depression. DESIGN, SETTING, AND PARTICIPANTS: The ADOPT PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) Depression pragmatic randomized clinical trial was conducted from August 10, 2021, through April 27, 2024, at primary care, psychiatry, or family medicine clinics at enrolling sites throughout the US. Patients were aged 8 years or older and had experienced depression for 3 months or longer. INTERVENTION: Patients were randomized to genotype-guided SSRI prescribing (intervention group) or usual care (control group). Actionable drug metabolism phenotypes were defined as those for which pharmacogenetic clinical guidelines recommend alternative medication selection or dose adjustment. MAIN OUTCOMES AND MEASURES: The primary outcome was change in Patient-Reported Outcomes Measurement Information System (PROMIS) depression T scores at 3 months among patients with the actionable phenotype. Secondary end points included adverse effect severity of SSRIs at 3 months and depression remission (measured with PROMIS depression scores and Patient Health Questionnaire-8 [PHQ-8] scores) at 6 months. RESULTS: This study of 1460 patients included 1239 adults (84.9%) (mean [SD] age, 40.6 [16.7] years) and 221 children (15.1%) (mean [SD] age, 14.6 [1.8] years). Most patients were female (1096 [75.1%]). A total of 692 patients (47.4%) had an actionable phenotype; 351 (50.7%) were assigned to the intervention, and 341 (49.3%) were assigned to usual care. At baseline, 463 of the 692 patients (66.9%) reported having depressive symptoms for more than 2 years, 603 (87.1%) were receiving pharmacologic treatment, and 354 (51.2%) were receiving nonpharmacologic treatment. At 3 months, no significant differences were observed between the intervention and usual care groups in change in PROMIS depression T scores (mean [SD] change, -4.3 [8.4] vs -4.0 [8.1]; P = .68), medication adverse effect burden (mean [SD] change, 8.2 [4.3] vs 7.8 [4.5]; P = .37), or Patient Health Questionnaire-8 score change (mean [SD] change, -3.3 [5.2] vs -2.7 [4.8]; P  = .13). However, at 6 months, the PROMIS depression T-score remission rate (score ≤16) was higher in the intervention group compared with the usual care group (153 of 317 patients [48.3%] vs 122 of 310 patients [39.4%]; P = .02). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, genotype-guided prescribing of SSRIs did not improve control of depression symptoms at 3 months compared with usual care but was associated with higher depression remission rates at 6 months. These findings suggest a possible longer-term clinical benefit and indicate that future studies should focus on the durability and long-term impact of genotype-guided prescribing in the management of depressive symptoms. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT04445792 (Master Protocol Research Program platform trial) and NCT05966155 (ADOPT PGx Depression trial).

Humans↗

The Indiana Chronic Disease Management Program.

The Indiana Chronic Disease Management Program (ICDMP) is intended to improve the quality and cost-effectiveness of care for Medicaid members with congestive heart failure (chronic heart failure), diabetes, asthma, and other conditions. The ICDMP is being assembled by Indiana Medicaid primarily from state and local resources and has seven components: (1) identification of eligible participants to create regional registries, (2) risk stratification of eligible participants, (3) nurse care management for high-risk participants, (4) telephonic intervention for all participants, (5) an Internet-based information system, (6) quality improvement collaboratives for primary care practices, and (7) program evaluation. The evaluation involves a randomized controlled trial in two inner-city group practices, as well as a statewide observational design. This article describes the ICDMP, highlights challenges, and discusses approaches to its evaluation.

Chronic Disease↗

Pelvic inflammatory disease during the post-partum year.

OBJECTIVE: To investigate the occurrence of, and risk factors for, pelvic inflammatory disease (PID) occurring during the post-partum year. METHODS: Demographic and clinical data for women who delivered a term infant with 5-minute Apgar score > or = 8 from 1992 through 1999 at a large urban hospital were extracted from an electronic medical record system. RESULTS: During the study period, 15 206 deliveries occurred among 12 549 women. PID was diagnosed during the post-partum year of 148 (1.0%) deliveries. In univariate analysis, young age, black race, and both pre-delivery history and post-partum diagnosis of chlamydial and gonococcal infection were associated with PID. In multivariate analysis, only young age and a positive test for gonorrhea before delivery or post-partum were independent predictors of PID. CONCLUSIONS: Pelvic inflammatory disease was diagnosed during the post-partum year in 1% of women studied. Young maternal age was an important demographic risk factor. Further investigation of post-partum STD acquisition and progression to PID is needed to determine whether women are at increased risk following delivery.

Chlamydia Infections↗

Indiana chronic disease management program risk stratification analysis.

OBJECTIVE: The objective of this study was to compare the ability of risk stratification models derived from administrative data to classify groups of patients for enrollment in a tailored chronic disease management program. SUBJECTS: This study included 19,548 Medicaid patients with chronic heart failure or diabetes in the Indiana Medicaid data warehouse during 2001 and 2002. MEASURES: To predict costs (total claims paid) in FY 2002, we considered candidate predictor variables available in FY 2001, including patient characteristics, the number and type of prescription medications, laboratory tests, pharmacy charges, and utilization of primary, specialty, inpatient, emergency department, nursing home, and home health care. METHODS: We built prospective models to identify patients with different levels of expenditure. Model fit was assessed using R statistics, whereas discrimination was assessed using the weighted kappa statistic, predictive ratios, and the area under the receiver operating characteristic curve. RESULTS: We found a simple least-squares regression model in which logged total charges in FY 2002 were regressed on the log of total charges in FY 2001, the number of prescriptions filled in FY 2001, and the FY 2001 eligibility category, performed as well as more complex models. This simple 3-parameter model had an R of 0.30 and, in terms in classification efficiency, had a sensitivity of 0.57, a specificity of 0.90, an area under the receiver operator curve of 0.80, and a weighted kappa statistic of 0.51. CONCLUSION: This simple model based on readily available administrative data stratified Medicaid members according to predicted future utilization as well as more complicated models.

Adult↗

Hospital resource utilization in childhood cancer.

To describe the patterns and predictors of hospital resource utilization in a cohort of children with newly diagnosed cancer, a retrospective cohort study of 195 consecutively diagnosed children with cancer at a single large Midwestern children's hospital was conducted. Patients were diagnosed between November 1995 and March 1997. All hospital encounters for these patients starting from the time of diagnosis to 3 years from diagnosis were identified using hospital administrative data. The patients were categorized into four diagnostic groups: lymphoid malignancies (acute lymphoblastic leukemia and lymphoma), myeloid leukemias (acute myeloid leukemia and chronic myeloid leukemia), central nervous system tumors, and solid tumors. Hospital charges and length of stay for patients in each diagnostic category were described. Predictive models for total resource consumption (total hospital charges) and intensive care use were derived. One hundred sixty-five of the 195 were admitted to Riley Hospital for Children at least once during the 3-year period following diagnosis. Among these 165, mean age at diagnosis was 6.9 years (minimum newborn, maximum 18.7 years). The ratio of boys to girls was 99:66 (1.5:1). The distribution of 165 diagnoses was as follows: 65 (39%) with lymphoid malignancy, 13 (8%) with myeloid leukemia, 36 (22%) with central nervous system tumors, and 51 (31%) with solid tumors. Sixty-two patients (38%) used the pediatric intensive care unit (PICU) at least once; 22 patients (13%) underwent stem cell transplantation. Sixty-five patients (39%) entered clinical trials. One hundred thirty-nine patients (84%) were alive at the end of 3 years. Three-year cumulative hospital charges were USD 16 million--almost USD 100,000/child hospitalized. Half of these charges were incurred in the first 4.5 months after diagnosis. Half of all hospital charges accrued to only 12.7% of patients; these patients were more likely to have a diagnosis of myeloid leukemia, to have undergone stem cell transplantation, and to have used the PICU. There were three independent predictors of hospital charges (log transformed): stem cell transplantation, PICU utilization, and death within 3 years of diagnosis. PICU utilization was predicted by tumor type (myeloid leukemia and central nervous system tumors were positive predictors of PICU utilization; lymphoid malignancy and solid tumors were negative predictors), stem cell transplantation, and death within 3 years of diagnosis. The authors conclude that hospitalization for childhood cancer is common, costly in the short term, and to some extent predictable. These data suggest that failures of current treatment not only lead to death but also add significantly to hospital resource utilization.

Adolescent↗

Prevalence of adrenocorticotropin deficiency in children with idiopathic growth hormone deficiency.

We sought to determine the prevalence of ACTH deficiency in children with GH deficiency (GHD) of unknown etiology with and without TSH deficiency and to correlate the structural characteristics of the hypothalamic-pituitary region on magnetic resonance imaging (MRI) with TSH and ACTH status. The electronic medical records system of a children's hospital was used to identify all patients less than 18 yr of age with GHD. TSH and ACTH deficiency were defined as being present if the patient was prescribed replacement hormone therapy. The medical records of 236 GHD subjects were reviewed, and the results of their MRI scans were recorded. Ninety had hypothalamic-pituitary-adrenal axis testing, and nine were ACTH deficient (10% of those tested; 4% of all subjects). Twenty-one (9%) of 236 were TSH deficient. All of the ACTH-deficient subjects were also TSH deficient: eight of nine had a gross abnormality on MRI, and one did not have an MRI report in the medical record. We conclude that patients with GHD, normal thyroid function, and no gross abnormalities on MRI do not need hypothalamic-pituitary-adrenal testing because no ACTH-deficient subjects would have been missed using this strategy (95% confidence interval, 0-5%).

Adolescent↗

Syphilis testing in association with gonorrhea/chlamydia testing during a syphilis outbreak.

We used an electronic medical records system retrospectively to evaluate how frequently, in a public hospital and its clinics, combined gonorrhea/chlamydia tests were accompanied by a syphilis test before and during a syphilis outbreak. Among 70,330 gonorrhea/chlamydia tests (1996-2000), the proportion with a syphilis test increased from 13% (preoutbreak) to 50% (intervention period) for men and from 6% to 13% for nonpregnant women. The increased syphilis testing coincided with a multifaceted public health intervention.

Adult↗

Oral erythromycin prophylaxis vs watchful waiting in caring for newborns exposed to Chlamydia trachomatis.

BACKGROUND: Chlamydia trachomatis exposure at birth may cause conjunctivitis or pneumonia. Until recently, a course of oral erythromycin prophylaxis was recommended for C trachomatis-exposed neonates. However, recognition of an association between erythromycin and pyloric stenosis prompted a change to a watchful waiting recommendation under which only infants who develop symptomatic C trachomatis infection are treated with oral erythromycin. OBJECTIVE: To compare erythromycin prophylaxis with watchful waiting for a hypothetical cohort of 100 000 neonates exposed to C trachomatis. METHODS: In a decision tree, potential outcomes were C trachomatis conjunctivitis, C trachomatis pneumonia (which could require inpatient or outpatient therapy), no clinical disease, and pyloric stenosis. Published data were reviewed to derive probability point estimates and ranges. Estimated charges served as outcome measures. RESULTS: Watchful waiting is less expensive than erythromycin prophylaxis ($15.1 million vs $28.3 million); prophylaxis prevents 5986 cases of C trachomatis pneumonia, including 1197 hospital admissions, but causes 3284 pyloric stenosis cases. (For every 30 infants given oral erythromycin prophylaxis, one additional case of pyloric stenosis would be expected to occur, and approximately 1.8 cases of C trachomatis pneumonia would be prevented.) In sensitivity analyses, if more than 3.4% of exposed neonates are hospitalized for C trachomatis pneumonia, prophylaxis becomes favored. CONCLUSIONS: This study supports the watchful waiting recommendation for asymptomatic C trachomatis-exposed neonates. However, there are wide plausible ranges for pyloric stenosis risk after erythromycin administration and for the incidence of C trachomatis pneumonia severe enough to require hospitalization; under some combinations of these rates, prophylaxis could be favored.

Anti-Bacterial Agents↗

Postpartum Chlamydia trachomatis and Neisseria gonorrhoeae infections.

OBJECTIVE: The purpose of this study was to investigate Chlamydia trachomatis and Neisseria gonorrhoeae infections that are diagnosed during the postpartum period (defined as the 3 months after delivery). STUDY DESIGN: This was a retrospective cohort study of women delivered of infants at >or=28 weeks of gestation at an urban hospital from 1992 through 1998, including each woman's first delivery during this period. Postpartum C trachomatis and N gonorrhoeae testing were routine. Data were extracted from an electronic medical record system. RESULTS: Of 13,086 women with eligible deliveries, 7258 women (55.5%) underwent postpartum C trachomatis tests; 191 of those women (2.6%) had positive test results. Similarly, 7148 women (54.6%) underwent postpartum N gonorrhoeae tests; 95 of those women (1.3%) had positive test results. Most women with positive postpartum tests had prenatal testing (182/191 with C trachomatis; 94/95 with N gonorrhoeae ), and the last prenatal test results were usually negative (153/182 women with negative prenatal C trachomatis testing; 91/94 women with negative prenatal N gonorrhoeae testing). CONCLUSION: Substantial rates of C trachomatis and N gonorrhoeae were found in postpartum women, most of whom had negative results on the last prenatal test.

Chlamydia Infections↗

Telephonic case-finding of major depression in a Medicaid chronic disease management program for diabetes and heart failure.

OBJECTIVE: Major depression is common in low-income and chronically ill persons and is a barrier for effective chronic disease care. We evaluated a Medicaid-sponsored strategy for detecting depressive symptoms in adults with diabetes or congestive heart failure. METHODS: Using a two-item screening tool, 890 adults enrolled in the Indiana Chronic Disease Management Program were assessed by telephone for depressive symptoms between December 2003 and March 2004. A subset of 386 participants also completed the eight-item Patient Health Questionnaire (PHQ-8) depression measure. Antidepressant use was examined using pharmacy claims. RESULTS: Depressed mood or anhedonia was reported by 51% of participants. About one in four participants had a PHQ-8 score indicating a high risk for major depression (score >or=10). The two-item screen was 96% sensitive [95% confidence interval (CI), 89-99%] and 60% specific (95% CI, 54-65%) for identifying members at high risk for depression by the full PHQ-8 instrument. Only half of participants with high-risk PHQ-8 scores had a pharmacy claim indicating that an antidepressant medication was filled within 120 days of the depression screening. CONCLUSIONS: A two-stage, telephonic approach involving the PHQ-8 instrument for Medicaid members with either depressed mood or anhedonia could identify two clinically depressed persons for every nine members screened.

Antidepressive Agents↗