[show abstract][hide abstract] ABSTRACT: Storytelling is emerging as a powerful tool for health promotion in vulnerable populations. However, these interventions remain largely untested in rigorous studies.
To test an interactive storytelling intervention involving DVDs.
Randomized, controlled trial in which comparison patients received an attention control DVD. Separate random assignments were performed for patients with controlled or uncontrolled hypertension. (ClinicalTrials.gov registration number: NCT00875225)
An inner-city safety-net clinic in the southern United States.
230 African Americans with hypertension.
3 DVDs that contained patient stories. Storytellers were drawn from the patient population.
The outcomes were differential change in blood pressure for patients in the intervention versus the comparison group at baseline, 3 months, and 6 to 9 months.
299 African American patients were randomly assigned between December 2007 and May 2008 and 76.9% were retained throughout the study. Most patients (71.4%) were women, and the mean age was 53.7 years. Baseline mean systolic and diastolic pressures were similar in both groups. Among patients with baseline uncontrolled hypertension, reduction favored the intervention group at 3 months for both systolic (11.21 mm Hg [95% CI, 2.51 to 19.9 mm Hg]; P = 0.012) and diastolic (6.43 mm Hg [CI, 1.49 to 11.45 mm Hg]; P = 0.012) blood pressures. Patients with baseline controlled hypertension did not significantly differ over time between study groups. Blood pressure subsequently increased for both groups, but between-group differences remained relatively constant.
This was a single-site study with 23% loss to follow-up and only 6 months of follow-up.
The storytelling intervention produced substantial and significant improvements in blood pressure for patients with baseline uncontrolled hypertension.
Finding Answers: Disparities Research for Change, a national program of the Robert Wood Johnson Foundation.
Annals of internal medicine 01/2011; 154(2):77-84. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: Guidelines recommend that patients with nonmetastatic rectal cancer receive surgery and adjuvant chemotherapy and/or radiation therapy (XRT) after surgery (especially if stage II and III). Studies reported that 90% of stage II and III patients received surgery, and 70% received adjuvant treatment. In states where socioeconomics and limited medical resources may hinder treatment, cancer care is understudied. The objective is to describe initiation and completion of rectal cancer treatment in Alabama.
Medicare claims were obtained for 675 stage I to III rectal cancer patients diagnosed in 1999-2003, enrolled in fee-for-service Medicare, and with at least 9 months of followup. Logistic regressions were used to identify significant differences by sex, age, and race in the likelihood of initiating treatment and receiving an incomplete course of chemotherapy or XRT (< or = 120 days of chemotherapy and < or = 28 days of XRT).
Overall, 90% received surgery, of which 43% received some adjuvant treatment. Among stage II to III patients, 58.8% received adjuvant treatment. Except for patients aged 75 years and greater being less likely to start chemotherapy, there were no significant differences in initiation by age, sex, and race. Depending on concurrent administration of chemotherapy and XRT, 29% to 35% received incomplete chemotherapy, and 16% to 23% incomplete XRT. Women were more likely to have incomplete chemotherapy than men.
Adjuvant treatment was less than reported in previous studies. Treatment initiation and completion did not differ across demographic factors. Future studies should explore reasons why older rectal cancer patients in Alabama are less likely to receive recommended treatment.
Journal of the National Medical Association 03/2010; 102(3):190-8. · 0.91 Impact Factor
[show abstract][hide abstract] ABSTRACT: Information on the health care costs associated with nonadherence to treatments for diabetes is both limited and inconsistent. We reviewed and critically appraised the literature to identify the main methodological issues that might explain differences among reports in the relationship of nonadherence and costs in patients with diabetes.
Two investigators reviewed Medline, EMBASE, Cochrane library and CINAHL and studies with information on costs by level of adherence in patients with diabetes published between January 1, 1997 and September 30th 2007 were included.
A total of 209 studies were identified and ten fulfilled the inclusion criteria. All included studies analyzed claims data and 70% were based on non-Medicaid and non-Medicare databases. Low medication possession ratios were associated with higher costs. Important differences were found in the ICD-9/ICD-9 CM codes used to identify patients and their diagnoses, data sources, analytic window period, definitions of adherence measures, skewness in cost data and associated statistical issues, adjustment of costs for inflation, adjustment for confounders, clinical outcomes and costs.
Important variation among cost estimates was evident, even within studies of the same population. Readers should be cautious when comparing estimated coefficients from various studies because methodological issues might explain differences in the results of costs of nonadherence in diabetes. This is particularly important when estimates are used as inputs to pharmacoeconomic models.
Value in Health 05/2009; 12(6):915-22. · 2.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: This study assesses the impact of computerized physician order entry (CPOE) implementation in pediatric hospitals on reported adverse drug events. Using a nested matched case-control design; we linked CPOE implementation information from the health information management systems society analytics database with reported adverse drug event (ADE) from the national association of children's hospitals and related institutions case mix comparative data program. Differences were examined using univariate and multivariate conditional logistic regression analyses. Patients from CPOE hospitals were more frequently seen in larger hospitals have more co-morbidities than those from non-CPOE hospitals. When matched by admitting diagnosis, age, gender and race, ADE cases were associated with more reported co-morbidities, and were reported less frequently in hospitals with CPOE. Patients from hospitals without CPOE were 42% more likely to experience reportable ADE after adjusting for the presence of co-morbidities. In conclusion, we found significant beneficial associations between reportable ADE and CPOE adoption in a representative sample of pediatric hospitals.
Pharmacoepidemiology and Drug Safety 05/2009; 18(8):751-5. · 2.90 Impact Factor
[show abstract][hide abstract] ABSTRACT: While self-efficacy plays an important role in physical activity, relatively little research has examined this construct in minorities. This study identified theoretical correlates associated with self-efficacy among insufficiently active, hypertensive Black women.
Correlates of self-efficacy to: (1) overcoming barriers to physical activity; (2) making time for activity; and (3) "sticking with" physical activity were studied.
Sixty-one women (M=50.48+/-4.2 years) participated. We accounted for 32% of the variance in confidence in overcoming barriers. Women confident in overcoming barriers reported less worry about physical activity. The TTM processes of change were also in the model: consciousness raising, environmental reevaluation, counter conditioning, and self-liberation. We accounted for 16% of the variance in "making time" self-efficacy. An aversiveness barrier (e.g., physical activity is boring, physical activity is hard work) was the dominant variable in the model. Confidence to 'stick with' physical activity was associated with self-reevaluation (i.e., reflection on how personal values correspond to behavior). Social support and competing demands were not associated with self-efficacy.
Consistent with Social Cognitive Theory, results suggest that self-efficacy is behavior specific and each measure likely provides unique information.
Interventions should be tailored to address specific self-efficacy types.
Patient Education and Counseling 08/2008; 72(1):137-45. · 2.37 Impact Factor
[show abstract][hide abstract] ABSTRACT: Objective: To assess associations between race/ethnicity and medication adherence, and the potential modifying effects of weight category (normal, overweight, obese) in a community-based sample. Study design and setting: We studied 1355 participants from the CARDIA (Coronary Artery Risk Development in Young Adults) study who were taking prescription medications in 2000-1. Medication adherence, as rated on the four-item Morisky medication adherence scale (score of 4 = maximum adherence), was reported for all participants. Results: The mean age +- SD of participants was 40 +- 3.6 years; 45% were African American and 36% were male. Overall, Whites had a higher proportion of maximum adherence than African Americans (59 vs 41%, respectively; p = 0.001). However, this difference was statistically significant only for participants within the normal weight category, of whom 54% of Whites were maximally adherent versus 35% of African Americans (p < 0.05). After adjustment for possible confounding covariates, race/ethnicity was associated with adherence only in those of normal weight: the odds ratio for maximum adherence in Whites versus African Americans of normal weight was 1.98 (95% CI 1.13, 3.47). Within race/ethnicity subgroups, weight category was associated with adherence in Whites but not in African Americans. Conclusion: Weight category modifies the association of race/ethnicity with medication adherence. The high levels of non-adherence observed among African Americans and obese and overweight Whites bodes poorly for treatment of obesity-associated diseases such as cardiovascular disease or diabetes mellitus.
The Patient: Patient-Centered Outcomes Research. 01/2008; 1(1):41-54.
[show abstract][hide abstract] ABSTRACT: In the past, postmarketing research, postmarketing surveillance and pharmacovigilance were synonymous with phase IV studies
because the main activities of the regulatory agency (e.g. FDA) were focused on the monitoring of adverse drug events and
inspections of drug manufacturing facilities and products. (1) However, the fact that not all FDA mandated (classical phase
IV trials) research consists of randomized controlled trials (RCTs), and not all postmarketing activities are limited to safety
issues (pharmacovigilance), these terms require clarification. This chapter attempts to clarify the confusing terminology;
and, to discuss many of the postmarketing research designs-both their place in clinical research as well as their limitations.
[show abstract][hide abstract] ABSTRACT: Background: Recent studies have suggested that there has been an increase in the number of `warning letters' issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion. Methods: All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached. Results: Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims. Discussion: There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines. Conclusion: We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the main causes of FDA issued warning letters for promotional claims related to medications.
[show abstract][hide abstract] ABSTRACT: The new drug application database submitted to the US Food and Drug Administration for drug approval (phases I-III or phases 1-3) is limited both in scope and size. Although randomized controlled trials, the hallmark of phase III trials, are the gold standard for the drug-approval process, they invariably have a number of limitations, including relatively small sample sizes, selective populations, short follow-up, the use of intermediate (surrogate) endpoints (almost always), and limited generalizability. The challenges of monitoring drugs once approved are also numerous. After approval by the Food and Drug Administration, marketed drugs undergo continued scrutiny, and this scrutiny is increasing because of problems that have surfaced with some drugs after their approval. Postmarketing research includes a variety of study designs and the use of registries and self-reporting of drug side effects. Along with this has come great confusion about what postmarketing research is and what a phase IV study is. Among the important strengths of phase IV research are the exposure of a broader range of patients to the drug under study, resulting in more "real-world" information about the drug's safety and efficacy, and consideration of a broader range of clinical endpoints. As a result, phase IV, or postmarketing research, has become an integral part of the drug evaluation process for a wide range of agents. The authors discuss the different types of study designs that are common under the phase IV terminology and provide some examples. They also discuss the use of registries and self-reporting of adverse events using the MedWatch System.
The Journal of Clinical Pharmacology 10/2007; 47(9):1074-86. · 2.84 Impact Factor