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Marcia A Testa

Publications and source records attributed to Marcia A Testa.

11 recordsLinked to original sources
PubMed2006

Quality-of-life and health benefits of early treatment of mild anemia: a randomized trial of epoetin alfa in patients receiving chemotherapy for hematologic malignancies.

BACKGROUND: Chemotherapy-related anemia is prevalent among patients with hematologic malignancies. A randomized, open-label, multicenter trial of early versus late epoetin alfa in this population was conducted, focusing on quality of life (QOL). METHODS: Patients with non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma and baseline hemoglobin of 10 to 12 g/dL who were scheduled for > or = 4 months of myelosuppressive chemotherapy were randomized to receive < or = 16 weeks of epoetin alfa at a dose of 40,000 U once weekly immediately (early) or to wait and only receive epoetin alfa if hemoglobin decreased to < 9 g/dL (late). Those patients with a hemoglobin level > 12 g/dL after 3 chemotherapy cycles were not randomized. The primary endpoint was a mean change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) total. RESULTS: In all, 269 patients with a hemoglobin level < or = 12 g/dL were randomized. The mean total FACT-An increased 3.84 (95% confidence interval [95% CI], 0.21-7.46) in early patients and decreased 4.37 (95% CI, -7.99 to -0.74) in late patients (P = .003). Early patients had significantly (P < .05) higher mean scores for total FACT-General; FACT-General physical and functional well-being subscales, total anemia scale, and fatigue subscale; and daily activity, energy, and important activity Linear Analog Scale Assessment scales, as well as reduced bedrest days and restricted activity days. The mean hemoglobin increased 1.2 g/dL (95% CI, 0.98-1.46) in early patients but decreased 0.2 g/dL (95% CI, -0.32-0.12) in late patients (P < .0001). Adverse events were similar between groups (with fatigue being the most prevalent); clinically relevant thromboembolic events were more common in early patients. CONCLUSIONS: Treating mild anemia immediately with epoetin alfa during chemotherapy for hematologic malignancy significantly improved QOL, productivity, and hemoglobin compared with delaying treatment until the hemoglobin level decreases to < 9.0 g/dL.

Adult↗
PubMed2006

The changing face of race: risk factors for neonatal hyperbilirubinemia.

OBJECTIVES: Race is a predictor of health outcomes and risk for some clinical conditions, for example, mother's race predicts risk for hyperbilirubinemia in newborns, with blacks at lowest risk. Little is known about the correlation of race as recorded in medical records with self-reported race. Also, use of maternal race to predict newborn risk for hyperbilirubinemia has not been tested for multiracial mothers and newborns. We sought to examine how maternal race documented in medical records correlates with self-reported race and to examine the correlation between mothers' and newborns' race in the context of risk for neonatal hyperbilirubinemia, focusing on multiracial mothers and newborns. DESIGN: A cohort study with 3021 newborns at > or =35 weeks gestation discharged from normal nursery between January 2001 and October 2002 with a telephone survey of their mothers within 6 months of birth. SETTING: The study was conducted in the Neonatology Department of Henry Ford Hospital. PATIENTS: There were 1773 mothers (58%) with incorrect telephone numbers. Of 1248 mothers contacted, 866 (69%) completed the interview. OUTCOME MEASURES: We measured mother's race in hospital database and mother's reported race for herself, her newborn, and the father, allowing < or =5 responses for each. RESULTS: Of mothers documented in the medical record as white, 64% self-reported as white. Among mothers recorded as black, 70% self-reported as black. Mothers identified 93 newborns as > or =2 races with primary race matching both parents for 41%, father for 25%, mother for 23%, and neither parent for 11%. Of 70 newborns whose parents were not the same race, mothers identified 45 (64%) as > or =2 races. CONCLUSIONS: There is incomplete overlap between racial identification in medical records versus self-report. Given 1 choice, mothers of multiracial infants overselect black in their newborns' ancestry. Because black race is the lowest risk category for neonatal hyperbilirubinemia, this may lead to underestimating their risk.

Female↗
PubMed2005

Four measures of antiretroviral medication adherence and virologic response in AIDS clinical trials group study 359.

AIDS Clinical Trials Group (ACTG) 359 was a randomized, partially double-blinded factorial study of 6 antiretroviral regimens, all including saquinavir, among HIV-infected persons in whom prior therapy had failed (n = 258). Counts of remaining saquinavir capsules were determined between weeks 0 and 4; at weeks 4, 8, and 16, self-reported adherence was estimated from 2-day report of doses skipped, therapeutic coverage, and percent of doses taken were determined by electronic monitoring devices applied to saquinavir bottles, and the saquinavir 24-hour area under the curve (AUC) was estimated. Relationships were evaluated among these 4 adherence measures and the primary endpoint of week 16 HIV RNA change. Thirty percent of 254 subjects had HIV RNA < or =500 copies/mL at week 16. Only self-reported adherence and saquinavir AUC were significantly associated with week 16 HIV RNA change (P = 0.019 and 0.023, respectively), and these measures were higher in subjects with week 16 HIV RNA < or =500 copies/mL (P = 0.03 and 0.008, respectively). The ability to detect a correlation between electronically monitored adherence and virologic response was limited by the small sample size. Self-reported adherence and saquinavir AUC were significant predictors of virologic response, in this evaluation. These findings provide insight into methods of assessing and improving adherence to antiretroviral regimens.

Acquired Immunodeficiency Syndrome↗
PubMed2004

Factors influencing medication adherence beliefs and self-efficacy in persons naive to antiretroviral therapy: a multicenter, cross-sectional study.

It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Beliefs about antiretroviral therapy and psychosocial characteristics of HIV-positive persons naive to therapy may influence early experience with antiretroviral medication adherence and therefore could be important when designing programs to improve adherence to antiretroviral therapy. As part of a multicenter AIDS Clinical Trial Group (ACTG 384) study, 980 antiretroviral-naive subjects (82% male, 47% White, median age 36 years, and median CD4 cell count 278 cells/mm3) completed a self-administered questionnaire prior to random treatment assignment of initial antiretroviral medications. Measures of symptom distress, general health and well-being, and personal and situational factors including demographic characteristics, social support, self-efficacy, depression, stress, and current adherence to (nonantiretroviral) medications were recorded. Associations among variables were explored using correlation and regression analyses. Beliefs about the importance of antiretroviral adherence and ability to take antiretroviral medications as directed (adherence self-efficacy) were generally positive. Fifty-six percent of the participants were "extremely sure" of their ability to take all medications as directed and 48% were "extremely sure" that antiretroviral nonadherence would cause resistance, but only 37% were as sure that antiretroviral therapy would benefit their health. Less-positive beliefs about antiretroviral therapy adherence were associated with greater stress, depression, and symptom distress. More-positive beliefs about antiretroviral therapy adherence were associated with better scores on health perception, functional health, social-emotional-cognitive function, social support, role function, younger age, and higher education (r values = 0.09-0.24, all p < .001). Among the subset of 325 participants reporting current use of medications (nonantiretrovirals) during the prior month, depression was the strongest correlate of nonadherence ( r = 0.33, p < .001). The most common reasons for nonadherence to the medications were "simply forgot" (33%), "away from home" (27%), and "busy" (26%). In conclusion, in a large, multicenter survey, personal and situational factors, such as depression, stress, and lower education, were associated with less certainty about the potential for antiretroviral therapy effectiveness and one's perceived ability to adhere to therapy. Findings from these analyses suggest a role for baseline screening for adherence predictors and focused interventions to address modifiable factors placing persons at high risk for poor adherence prior to antiretroviral treatment initiation.

Acquired Immunodeficiency Syndrome↗
PubMed2003

Who receives lipid-lowering drugs: the effects of comorbidities and patient characteristics on treatment initiation.

AIMS: Little is known about the effects of comorbidities and patient characteristics on treatment initiation of lipid-lowering drugs (LLDs), which can be helpful in the evaluation of the risks and benefits of LLDs. METHODS: Baseline characteristics among subjects who received their first ever-recorded LLD prescription in general practice between 1 January 1990 and 31 December 1997, and hyperlipidaemic patients without LLD therapy during the same period were obtained from the UK General Practice Research Database. Differences between patients who received and patients who did not receive LLDs, as well as patients who received different classes of LLDs were compared by fitting multivariate logistic regression models that adjusted for age, sex, body mass index, smoking status, and year of treatment initiation or hyperlipidaemia diagnosis. RESULTS: We found that there were many differences in the baseline characteristics, such as number of general practitioner visits, diagnosis and severity of cardiovascular diseases, and concurrent medications, between the 25 331 patients who received and the 16 287 patients who did not receive LLDs. We also noted that patients with statin therapy had more prior hospitalization, more recent myocardial infarction/stroke, and more concurrent cardiovascular medications, than those patients who received other LLDs. CONCLUSIONS: Patients who received LLDs in primary care, especially patients with statin therapy, were more likely to be elderly and to have more concomitant severe cardiovascular comorbidities than those hyperlipidaemic patients who did not receive LLDs. Examining the medical records of individuals eligible for LLD therapy is an important first step in selectively targeting who will experience the greatest benefit to risk ratio for the treatment of hyperlipidaemia, and is an important step in avoiding confounding by indication when designing epidemiological studies comparing the risks and benefits of treatments for hyperlipidaemia.

Adult↗
PubMed2003

Discontinuation and switching of therapy after initiation of lipid-lowering drugs: the effects of comorbidities and patient characteristics.

AIMS: To evaluate the effects of comorbidities and patient characteristics on treatment continuation among patients starting their first course of lipid-lowering drug (LLD) therapy. METHODS: Within the UK General Practice Research Database (GPRD), we identified 22 408 patients who started LLD therapy due to coronary heart disease, hyperlipidaemia, or other atherosclerotic diseases, and who received > or = two prescriptions for LLD between January 1 1990 and December 31 1997. Differences in potential predictors of treatment continuation between patients who continued, and patients who discontinued/switched lipid-lowering therapy within 1 year after treatment initiation were compared by fitting multivariate logistic regression models. The effects of baseline characteristics on treatment continuation after switching of LLDs were also analysed. RESULTS: Discontinuation/switching of lipid-lowering therapy was common during the study period, especially among patients who received nonstatin, nonfibrate LLDs (log-rank test P = 0.0001). Statin use, more frequent physician visits, more concurrent cardiovascular medications, diabetes, and fewer noncardiovascular medications were associated with treatment continuation of LLDs. Among patients who switched therapy, prescribing of a statin as the substituted LLD, more concurrent cardiovascular medications, and later treatment switching were related to a higher probability of treatment continuation after switching LLDs. CONCLUSIONS: Treatment continuation after initiation or switching of lipid-lowering therapy largely increased with concomitant cardiovascular comorbidities, and more health care utilization, and is more common for statins than for other LLDs. Practice guidelines, patient education, and quality of care assessment for lipid-lowering therapy should emphasize factors that predispose patients to discontinuation/switching, in an effort to optimize the choice of therapeutic regimens and to improve patient adherence.

Adult↗
PubMed2003

Management of hyperbilirubinemia in newborns: measuring performance by using a benchmarking model.

BACKGROUND: Accreditors hold hospitals accountable for harm from serious newborn hyperbilirubinemia, yet standards for evaluating performance in prevention are lacking. OBJECTIVE: We confirmed prognostic variables for newborn hyperbilirubinemia and developed a benchmarking model for self-evaluation of hyperbilirubinemia management. METHODS: We conducted a 3-year prospective cohort study in the Henry Ford Health System (HFHS) on 5507 healthy newborns of >or=35 weeks' gestational age. HFHS follows a rigorous protocol for hyperbilirubinemia management. Defining hyperbilirubinemia as age-specific levels of total serum bilirubin exceeding American Academy of Pediatrics criteria for considering phototherapy and severe hyperbilirubinemia as total serum bilirubin >or=20 mg/dL, we used logistic and Poisson regressions to determine predictors and estimate parameters for a benchmarking model. We compared incidence rates for severe hyperbilirubinemia from HFHS to aggregate data from 11 hospitals reported to have less rigorous management. RESULTS: Newborns were 52.9% black, 14.4% white, 24.3% Latino, and 2.4% Asian; 30% were exclusively and 28% partially breastfed. Regression analyses revealed associations for hyperbilirubinemia and severe hyperbilirubinemia with black mothers (negative) and exclusive or partial breastfeeding and younger gestational age (positive). Male newborns and older mothers were also associated with severe hyperbilirubinemia. For all 5 variables, we found a lower risk for severe hyperbilirubinemia at HFHS than in the comparison hospital group. To compare hospitals, we developed a benchmarking model for incidence of hyperbilirubinemia adjusting for race, feeding method, and gestational age. CONCLUSIONS: Hospitals with access to newborns' inpatient and postdischarge data can use our benchmarking model to compare their management of hyperbilirubinemia with a reference population that received rigorous care.

Benchmarking↗
PubMed2002

Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study.

PURPOSE: Liposomal anthracyclines and paclitaxel are considered the best available cytotoxic therapies for Kaposi's sarcoma (KS), but relapse is common. To identify new interventions for relapsed or progressive KS, a phase II study of low-dose etoposide to assess its toxicity and efficacy was conducted. PATIENTS AND METHODS: Thirty-six patients with high-risk KS were treated with oral etoposide 50 mg/d for 7 consecutive days of every 2-week cycle. All patients' disease had relapsed or progressed after prior combination chemotherapy or anthracycline therapy. For patients without a complete or partial response after two cycles of therapy and no toxicity greater than grade 2, the dose of etoposide was escalated to 100 mg/d orally on days 1 to 7 of each 14-day cycle. Treatment-related and disease-specific quality of life was evaluated using patient reports on the General Health Self-Assessment Form and a KS-specific measure. RESULTS: One patient achieved a complete response, 12 patients had a partial response (overall response rate, 36.1%), and stable disease was observed in 12 patients (33.3%). Tumor responses were seen in all disease sites. Fourteen patients had their dose escalated, of whom five responded. The median time to response was 17.7 weeks; the median duration of response was 25 weeks. The most frequent hematologic abnormality was neutropenia, which was grade 4 in seven patients and grade 3 in six. Opportunistic infections occurred in eight patients during the treatment period. Both response to treatment and toxicity influenced patient-reported quality of life. CONCLUSION: We conclude that low-dose oral etoposide at a dose of 50 mg/d is safe and effective for the treatment of refractory or progressed AIDS-related KS and has an overall positive effect on the quality of life of responding patients.

Acquired Immunodeficiency Syndrome↗
PubMed2002

Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: a randomized phase II AIDS clinical trials group study.

We wished to evaluate the efficacy and safety of a low and an intermediate daily dose of interferon-alpha2b (IFN-alpha2b) with didanosine in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi's sarcoma (KS). HIV-seropositive subjects with biopsy-confirmed cutaneous KS were randomized to receive either a low (1 million IU) or an intermediate (10 million IU) dose of IFN-alpha2b once daily with twice daily doses of didanosine. Treatment assignment was stratified by CD4 count. Response, toxicity, changes in CD4 counts, and survival were evaluated. Sixty-eight eligible subjects were accrued, 35 to low-dose and 33 to intermediate-dose IFN-alpha2b. The response rate was 40% in the low-dose group (95% CI, 24-58) and 55% in the intermediate-dose group (95% CI, 36-72) (p = 0.338). The median response duration was approximately 110 weeks in both groups. Intermediate-dose IFN induced grade 3/4 neutropenia more often (21% vs. 3%, p = 0.048) and grade 3/4 toxicity faster (p = 0.0231) and necessitated treatment discontinuation earlier for drug-related toxicities (p = 0.0416) than low-dose IFN. There were no significant differences in survival between the treatment groups. Baseline CD4 count was the only significant factor predicting response. Once-daily low-dose and intermediate-dose IFN-alpha2b induced similar response rates, which were achieved without optimal antiretroviral therapy. The slightly higher response rate in the intermediate-dose group was offset by its significantly poorer tolerance. These findings justify the use of lower, well-tolerated IFN doses for treatment of KS with currently used antiretroviral regimens.

Acquired Immunodeficiency Syndrome↗