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302


Exploring the utility of automated drug alerts in home healthcare

Feldman, Penny Hollander; McDonald, Margaret; Rosati, Robert J; Murtaugh, Christopher; Kovner, Christine; Goldberg, Judith D; King, Lori
Computerized drug utilization review (DUR) can potentially reduce adverse drug events. We examined automated DUR for home healthcare patients with diabetes or hypertension. Sixty-eight percent of diabetes patients and 50.7% of hypertension patients triggered severe, moderate, or duplicative alerts. Among diabetes patients, 74.3% of duplicative alerts were trivial or inappropriate, compared with 3.9% among hypertension patients. Experts judged that 40.5% of high-risk diabetes patients and 53.6% of hypertension patients had alerts requiring nurse follow-up. Adequate follow-up was significantly lower for the former. The relationship between inappropriate alerts and poorer follow-up reinforces the need for more specific alert systems to focus clinicians' attention on clinically important alerts.
PMID: 16681298
ISSN: 1062-2551
CID: 156593

False discovery rate for statistical designs to test both superiority and non-inferiority in controlled

Mukhi, Vandana; Goldberg, Judith; Shao, Yongzhao
ORIGINAL:0006006
ISSN: 1543-3218
CID: 71028

The changing role of statistics in medical research : experiences from the past and directions for the future. Invited paper

Goldberg, Judith D
ORIGINAL:0006007
ISSN: 1543-3218
CID: 71155

Evaluation of pro-carboxypeptidase A and carboxypeptidase A as serologic markers for adenocarcinoma of the pancreas

Shamamian, Peter; Goldberg, Judith D; Ye, Xiang Y; Stewart, Jonathan D; White, Peter J; Gilvarg, Charles
Background: A serological marker for pancreatic cancer may allow for early detection and potentially more effective treatments. Pro-carboxypeptidase A (pro-CPA) is produced exclusively in the pancreas and converted to its active form, CPA, in the intestinal lumen. We hypothesized that alterations in serum pro-CPA and/or CPA may be useful as a diagnostic test for pancreatic cancer. Patients and methods: Serum samples obtained from 34 patients with pancreatic adenocarcinoma prior to surgical intervention and 64 control patients were assayed for pro-CPA and CPA. A variety of statistical methods was used to evaluate the utility of these measurements individually and in combination to classify the samples with respect to the presence or absence of pancreatic adenocarcinoma. Results: Because of positive skewing of the data in some populations, transformation of the data to natural logarithmic scales was used and resulted in normal distributions. All pancreatic cancer patients had ln(CPA) levels within or below the normal range defined as two standard deviations from the control group mean (-2.714+/-0.413). Ln(pro-CPA) levels in 24 of 34 cancer patients were outside the normal range of the control group (0.306+/-0.33). Pancreatic cancer patients with ln pro-CPA values within the control range had low ln CPA, advanced stage and/or evidence of pancreatic insufficiency. While each of these individual values (ln pro-CPA or ln CPA) does not adequately separate all control from cancer patients, a bivariate classification rule is presented that uses both ln pro-CPA and ln CPA simultaneously to predict the presence of pancreatic cancer with a sensitivity of 91% and a specificity of 95%. Conclusions: The data presented suggest that abnormalities in serum pro-CPA and CPA levels are associated with the presence of pancreatic cancer
PMCID:2020764
PMID: 18333101
ISSN: 1365-182x
CID: 96470

Quality of life and behavioral follow-up study of pediatric survivors of craniopharyngioma

Sands, Stephen A; Milner, Jessica S; Goldberg, Judith; Mukhi, Vandana; Moliterno, Jennifer A; Maxfield, Carol; Wisoff, Jeffrey H
OBJECT: The authors set out to evaluate the quality of life (QOL), social-emotional functioning, and behavioral functioning of children treated surgically for craniopharyngiomas. METHODS: Twelve girls and 17 boys with a mean age at diagnosis of 8 +/- 3.8 years were surgically treated between 1985 and 1998 at the New York University Medical Center. After a mean follow-up period of 6.8 +/- 3.5 years, these 29 patients were administered either the 36-item Short Form Health Survey version 2 or the Child Health Questionnaire-Parent Form to assess QOL, as well as the Achenbach Child Behavior Checklist or Young Adult Checklist to measure social-emotional and behavioral functioning. Patients older than 19 years of age and parents of patients younger than 19 years of age reported low average overall physical QOL, with overall psychosocial QOL in the average range. Behavioral difficulties were noted, including internalizing, attention, somatic, and social difficulties. Further analyses indicated that retrochiasmatic tumor location, recurrence, and additional surgery were associated with poorer outcomes. In contrast, hydrocephalus, tumor size, and sex were not prognostic variables, and patients significantly improved as post-operative time increased. CONCLUSIONS: Attention toward late effects arising after the treatment of pediatric craniopharyngioma, including decreased postoperative physical health and behavioral functioning, is warranted. Future approaches to treatment should consider the documented effects of either gross-total resection or limited surgery followed by cranial irradiation on QOL, with specific evaluation for those with retrochiasmatic tumors, a recurrent tumor, or the need for additional surgery. Psychosocial QOL and social-emotional functioning should be maintained through ongoing counseling and education
PMID: 16270681
ISSN: 0022-3085
CID: 71024

Helicobacter pylori and overweight status in the United States: data from the Third National Health and Nutrition Examination Survey

Cho, Ilseung; Blaser, Martin J; Francois, Fritz; Mathew, Jomol P; Ye, Xiang Y; Goldberg, Judith D; Bini, Edmund J
Obesity is an important public health problem in the United States. Because of its potential effects on gastric leptin homeostasis, Helicobacter pylori may play a role in regulating body weight. The authors' aim in this study was to examine the association between H. pylori colonization and overweight status. Nonpregnant participants in the Third National Health and Nutrition Examination Survey (1988-1994) aged > or = 20 years who had had H. pylori testing performed and body mass index (weight (kg)/height (m2)) measured were studied. Overweight was defined as a body mass index greater than or equal to 25. On the basis of serologic results, the participants were categorized into three H. pylori status groups: H. pylori-positive and cytotoxin-associated gene A (cagA)-positive (H. pylori+ cagA+), H. pylori-positive and cagA-negative (H. pylori+ cagA-), and H. pylori-negative (H. pylori-). Of the 7,003 subjects with complete body mass index and H. pylori data, 2,634 (weighted percentage, 22.9%) were H. pylori+ cagA+, 1,385 (15.1%) were H. pylori+ cagA-, and 2,984 (62.0%) were H. pylori-. The adjusted odds of being overweight were 1.17 (95% confidence interval: 0.98, 1.39; p = 0.075) for the H. pylori+ cagA+ group and 0.99 (95% confidence interval: 0.80, 1.22; p = 0.92) for the H. pylori+ cagA- group in comparison with H. pylori- subjects. Serum leptin levels did not differ significantly between the three H. pylori groups. In this US population-based study, there was no significant association between H. pylori colonization, cagA+ strains of H. pylori, and being overweight
PMID: 16093294
ISSN: 0002-9262
CID: 58658

Fludrocortisone in patients with familial dysautonomia--assessing effect on clinical parameters and gene expression

Axelrod, Felicia B; Goldberg, Judith D; Rolnitzky, Linda; Mull, James; Mann, Sandra P; Gold von Simson, Gabrielle; Berlin, Dena; Slaugenhaupt, Susan A
The common familial dysautonomia (FD) mutation causes a splicing defect that leads to production of both wild-type (WT) and mutant (MU) IKBKAP mRNA. Because drugs may alter splicing, seven drugs, fludrocortisone, midodrine, diazepam, albuterol, clonidine, caffeine, and dopamine were screened. Since only fludrocortisone negatively altered gene expression, we assessed fludrocortisone's efficacy in treating postural hypotension, and its effect on survival and secondary long-term FD problems. For 341 FD patients we obtained demographic data and clinical information from the last Center evaluation (most current or prior to death) including mean blood pressures (supine, 1 min erect and 5 min erect) and history regarding syncope and presyncope symptoms. For 175 fludrocortisone-treated patients, data from the evaluation prior to start of fludrocortisone and from the last Center evaluation were compared. The fludrocortisone-treated patient cohort was compared to the nontreated patient cohort with respect to overall survival and event-free survival for crisis frequency, worsening gait, frequent fractures, spine curvature, renal insufficiency, and pacemaker insertion. Overall survivals of patients on fludrocortisone alone, on fludrocortisone and midodrine, and on neither drug were compared. Cumulative survival was significantly higher in fludrocortisone-treated patients than in non-treated patients during the first decade. In subsequent decades, the addition of midodrine improved cumulative survival. Fludrocortisone significantly increased mean blood pressures and decreased dizziness and leg cramping, but not headaches or syncope. Fludrocortisone was associated with more long-term problems, which may reflect more symptomatic status associated with longer survival. Our data suggest that fludrocortisone has clinical efficacy despite negative in vitro observations on gene expression
PMID: 16032383
ISSN: 0959-9851
CID: 58717

The importance of location in determining breast conservation rates

Hiotis, Karen; Ye, Wei; Sposto, Richard; Goldberg, Judith; Mukhi, Vandana; Skinner, Kristin
BACKGROUND: This study evaluates differences in the utilization of breast conservation surgery (BCS) between major metropolitan areas in the United States (US) and the United Kingdom (UK). METHODS: Surgical and staging information were obtained from the Cancer Surveillance Program for Los Angeles County (LAC), the New York State (NYS) Department of Health Cancer Registry, and the UK National Health Service (NHS) Breast Screening Program. Demographic data were obtained from the census databases from the US, UK, Northern Ireland, and Scotland. Descriptive statistics, correlation analysis, and chi-square tests were used to compare rates of BCS across the locations under study. RESULTS: Breast conservation rates were highest in London (79.3%) compared to New York City (NYC) (69.7%) and LAC (66.5%) (P < .0001). Both in NYS and the UK, the cities differ from the surrounding regions in population density, education levels, agricultural activities, and unemployment. BCS rates tended to increase with population density and education levels, and decrease with increased unemployment and agricultural activity, but there was no impact on BCS rates when adjustments for these variables were included in regression models. BCS rates increase with increasing hospital case volume in LAC and NYC (P < .0001). CONCLUSION: When comparing large metropolitan areas in the US and UK there are significantly different rates of BCS in different locations. These differences reflect differences in population density, socioeconomic status (SES), education levels, hospital volume, and the effects of a nationally funded screening program
PMID: 15972165
ISSN: 0002-9610
CID: 71025

Examining nurses' decision process for medication management in home care

Kovner, Christine; Menezes, Joyce; Goldberg, Judith D
BACKGROUND: The process of medication management within home care agencies was prospectively described, with a focus on the nurse's role and critical points in the process. The process the nurse must follow includes preparing, checking, and administering medications; updating knowledge of medications; monitoring the effectiveness of treatment; reporting adverse reactions; and teaching patients about their drugs. PROCESSES FOR MEDICATION MANAGEMENT IN HOME HEALTH CARE: The steps that home health nurses (HHNs) go through with families and the system changes that could be developed to decrease errors were identified. The approach was based on Failure Mode and Effects Analysis-a method to identify and prevent process problems before they occur. The medication management process was divided into drug utilization review (DUR) for duplicative and harmful interactions; drug administration by the patient, family member, and/or caregiver; and side effects. Failure modes were developed for a DUR for duplicative and harmful interactions. DISCUSSION: Home health agencies should analyze the medication management process in their own agencies and identify system solutions. The difficulty encountered by HHNs in contacting physicians to discuss changes to the drug regimen following the assessment of potential drug interactions or duplications is an ongoing problem. Careful monitoring by HHNs could decrease the impact of adverse drug effects.
PMID: 16130981
ISSN: 1553-7250
CID: 156556

The importance of end-systole for optimal reconstruction protocol of coronary angiography with 16-slice multidetector computed tomography

Sanz, Javier; Rius, Teresa; Kuschnir, Paola; Fuster, Valentin; Goldberg, Judith; Ye, Xiang Y; Wisdom, Paul; Poon, Michael
OBJECTIVES: Multidetector-row computed tomography coronary images are usually analyzed in mid-diastole (MD). Because of slow coronary motion also in end-systole (ES), we evaluated the impact on image quality of including ES images and defined an efficient reconstruction protocol. MATERIAL AND METHODS: In 50 coronary multidetector-row computed tomography studies, 9 reconstructions (at 10% increments of the RR interval) were graded for image quality. Multiple combinations of reconstructions were compared. RESULTS: MD (60-70% of the RR interval) offered the best image quality. In 44% patients, the best reconstruction for >or=1 coronary was found in ES (20-30%). Their heart rate was higher (68.2+/-9.9 bpm vs. 59.2+/-8.8 bpm, P=0.0014). Combining ES and MD consistently offered superior image quality and less nonevaluable vessels than even larger numbers of diastolic reconstructions alone. A combination of 2-3 reconstructions was most efficient. Adding more reconstructions did not significantly improve results. CONCLUSIONS: Combining ES and MD reconstructions reduces nonevaluable coronary arteries, particularly with higher heart rates. A protocol including 2-3 reconstructions is the most efficient
PMID: 15714090
ISSN: 0020-9996
CID: 71026