Browsing by Author "Schulman, Kevin A"

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Open Access
Can prospect theory explain risk-seeking behavior by terminally ill patients?
(Med Decis Making, 2005-11) Rasiel, Emma B; Weinfurt, Kevin P; Schulman, Kevin A
Patients with life-threatening conditions sometimes appear to make risky treatment decisions as their condition declines, contradicting the risk-averse behavior predicted by expected utility theory. Prospect theory accommodates such decisions by describing how individuals evaluate outcomes relative to a reference point and how they exhibit risk-seeking behavior over losses relative to that point. The authors show that a patient's reference point for his or her health is a key factor in determining which treatment option the patient selects, and they examine under what circumstances the more risky option is selected. The authors argue that patients' reference points may take time to adjust following a change in diagnosis, with implications for predicting under what circumstances a patient may select experimental or conventional therapies or select no treatment.
Open Access
Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.
(PLoS One, 2008-05-07) Weinfurt, Kevin P; Seils, Damon M; Tzeng, Janice P; Lin, Li; Schulman, Kevin A; Califf, Robert M
BACKGROUND: Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. CONCLUSIONS/SIGNIFICANCE: In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.
Open Access
Evaluating the Quality of Anti-Hypertensive Drugs in Lagos State, Nigeria
(2018) Ndichu, Elizabeth Thithi
ABSTRACT
Background
As the burden of non-communicable diseases grows, access safe to medical therapy is increasing in importance. The aim of this study was to develop a methodology for establishing the prevalence of the quality of anti-hypertensive drugs and to examine whether this prevalence varies by socio-economic variables.
Methods
Through a cross-sectional survey study design, 6 local government areas(LGA) in Lagos State,Nigeria were sampled. A list of all registered pharmacies in the state, derived from the Pharmacists Council of Nigeria, was used in the sampling process. A mystery shopper randomly purchased 102 samples (14 brands) of the antihypertensive nifedipine from 17 pharmacies in each of the six LGA in Lagos State. Definitive drug quality was assessed through High-Performance Lipid Chromatography (HPLC). The quality assessment comprised two main domains; the level of active pharmaceutical ingredients (API) was used to identify falsely labelled drugs whereas the amounts of impurities revealed substandard drug samples. Good quality drugs met specifications for both the API and impurities.
Results
Seventy-eight (76%) drug samples did not meet both quality standards. Of the 30 falsely labelled drugs,17(56.67%) emanated from LGA categorized as low social economic status or hard-to-reach, 18( 60%) were manufactured in Asia and had a price average of 375.67 Nigerian Naira(NGN).Seventy six(74.51%) drug samples were substandard with 40(52.63%) drug samples emanating from high social economic status LGA,37(48.68%) were manufactured in Asia and had a price average of 383.33 NGN.
Of the 102 samples collected, 24 (23.53%) complied with both tolerance limits; 72 (70.59%) met the active pharmaceutical ingredient standards; and 26 (25.49%) met the drug purity standards. Most of the good quality drug samples, 14(58.33%),were from low social economic status LGA,15 (62.5%) were manufactured in Asia and had a price average of 375.67 NGN.
Conclusion
We found a high prevalence of falsely labeled and substandard drug samples with only 24(23.53%) having good quality. To treat non-communicable diseases, we need efforts to monitor and assure drug quality for populations.
Open Access
STAR 3 randomized controlled trial to compare sensor-augmented insulin pump therapy with multiple daily injections in the treatment of type 1 diabetes: research design, methods, and baseline characteristics of enrolled subjects.
(Diabetes Technol Ther, 2010-04) Davis, Stephen N; Horton, Edward S; Battelino, Tadej; Rubin, Richard R; Schulman, Kevin A; Tamborlane, William V
BACKGROUND: Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes. METHODS: Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c < or =7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c < or =7%, key safety end points, user satisfaction, and responses on standardized assessments. RESULTS: A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010. CONCLUSIONS: Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI.
Open Access
Who enrolls in the Medicare Part D prescription drug benefit program? Medication use among patients with heart failure.
(J Am Heart Assoc, 2013-09-11) Eapen, Zubin J; Hammill, Bradley G; Setoguchi, Soko; Schulman, Kevin A; Peterson, Eric D; Hernandez, Adrian F; Curtis, Lesley H
BACKGROUND: Dispensing data from Medicare Part D standalone prescription drug plans are now available, but characteristics of enrollees with heart failure have not been well described. METHODS AND RESULTS: We identified 81 874 patients with prevalent heart failure as of January 1, 2010, in a nationally representative 5% sample of Medicare beneficiaries. We classified patients according to enrollment in a Medicare Part D plan as of January 1, 2010. Demographic characteristics, comorbid conditions, and prescriptions were compared by enrollment status. A total of 49 252 (60.2%) were enrolled in a Medicare Part D plan as of January 1. Enrollees were more often women, black, and of lower socioeconomic status. Enrollees with heart failure more often filled prescriptions for loop diuretics than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, or aldosterone antagonists. During the first 4 months of 2010, 5444 (12.3%) reached the coverage gap, and 566 (1.3%) required catastrophic coverage beyond the gap. CONCLUSIONS: Medicare beneficiaries with heart failure differ significantly according to enrollment in Part D prescription drug plans and represent a population underrepresented in clinical efficacy trials. Many face the coverage gap, and few select Medicare Part D plans that provide coverage during the gap. Linking Medicare Part D event data with clinical registries could help to determine whether eligible enrollees are undertreated for heart failure.