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Biomedical subjects

Michael Pignone

Publications and source records attributed to Michael Pignone.

At least 19 recordsLinked to original sources
PubMed2006

Aspirin, statins, or both drugs for the primary prevention of coronary heart disease events in men: a cost-utility analysis.

BACKGROUND: Aspirin and statins are both effective for primary prevention of coronary heart disease (CHD), but their combined use has not been well studied. OBJECTIVE: To perform a cost-utility analysis of the effects of aspirin therapy, statin therapy, combination therapy with both drugs, and no pharmacotherapy for the primary prevention of CHD events in men. DESIGN: Markov model. DATA SOURCES: Published literature. TARGET POPULATION: Middle-aged men without a history of cardiovascular disease at 6 levels of 10-year risk for CHD (2.5%, 5%, 7.5%, 10%, 15%, and 25%). TIME HORIZON: Lifetime. PERSPECTIVE: Third-party payer. INTERVENTIONS: Low-dose aspirin, a statin, both drugs as combination therapy, or no therapy. OUTCOME MEASURE: Cost per quality-adjusted life-year gained. RESULTS OF BASE-CASE ANALYSIS: For 45-year-old men who do not smoke, are not hypertensive, and have a 10-year risk for CHD of 7.5%, aspirin was more effective and less costly than no treatment. The addition of a statin to aspirin therapy produced an incremental cost-utility ratio of 56,200 dollars per quality-adjusted life-year gained compared with aspirin alone. RESULTS OF SENSITIVITY ANALYSIS: Excess risk for hemorrhagic stroke and gastrointestinal bleeding with aspirin, risk for CHD, the cost of statins, and the disutility of taking medication had important effects on the cost-utility ratios. LIMITATIONS: Several input parameters, particularly adverse event rates and utility values, are supported by limited empirical data. Results are applicable to middle-aged men only. CONCLUSIONS: Compared with no treatment, aspirin is less costly and more effective for preventing CHD events in middle-aged men whose 10-year risk for CHD is 7.5% or higher. The addition of a statin to aspirin therapy becomes more cost-effective when the patient's 10-year CHD risk before treatment is higher than 10%.

Aspirin↗
PubMed2006

Measures used in studies of informed decision making about cancer screening: a systematic review.

Interventions to promote informed decision making (IDM) for cancer screening are increasingly common. The resulting body of literature provides an opportunity for a systematic review of measures in use. We searched standard databases for intervention trials and other studies of screening decisions and decision aids, finding 2,110 unique citations (most with abstracts) that we reduced to 104 full-text articles; 36 studies met inclusion criteria (prostate = 20, colorectal = 9, breast = 6, cervical = 1). Two independent coders abstracted data on study characteristics, constructs, and measures. Our findings revealed that most studies measured screening (or intention) and knowledge; fewer measured recommended IDM-related constructs and none measured all outcomes proposed for evaluating IDM interventions. Validity and reliability of measures received inadequate attention in study reports, and conceptual overlap exists among measures. Few IDM measures have been developed/carefully adapted from treatment measures and tested for cancer screening or in diverse populations. We recommend that new and in-progress studies emphasize outcomes beyond knowledge-participation in decision making according to personal preference, satisfaction with the process, and consistency between decisions and values. Also needed is better use of theory to guide conceptualization and operationalization of measures, greater attention to reliability and validity (particularly in diverse populations), more thorough reporting of sources and operating characteristics of measures, and increased emphasis and resources focused on these issues by funders, researchers, and journal editors.

Decision Making↗
PubMed2005

Development and initial testing of a computer-based patient decision aid to promote colorectal cancer screening for primary care practice.

BACKGROUND: Although colorectal cancer screening is recommended by major policy-making organizations, rates of screening remain low. Our aim was to develop a patient-directed, computer-based decision aid about colorectal cancer screening and investigate whether it could increase patient interest in screening. METHODS: We used content from evidence-based literature reviews and our previous decision aid research to develop a prototype. We performed two rounds of usability testing with representative patients to revise the content and format. The final decision aid consisted of an introductory segment, four test-specific segments, and information to allow comparison of the tests across several key parameters. We then conducted a before-after uncontrolled trial of 80 patients 50-75 years old recruited from an academic internal medicine practice. RESULTS: Mean viewing time was 19 minutes. The decision aid improved patients' intent to ask providers for screening from a mean score of 2.8 (1 = not at all likely to ask, 4 = very likely to ask) before viewing the decision aid to 3.2 afterwards (difference, 0.4; p < 0.0001, paired t-test). Most found the aid useful and reported that it improved their knowledge about screening. Sixty percent said they were ready to be tested, 18% needed more information, and 22% were not ready to be screened. Within 6 months of viewing, 43% of patients had completed screening tests. CONCLUSION: We conclude that a computer-based decision aid can increase patient intent to be screened and increase interest in screening. PRACTICE IMPLICATIONS: This decision aid can be viewed by patients prior to provider appointments to increase motivation to be screened and to help them decide about which modality to use for screening. Further work is required to integrate the decision aid with other practice change strategies to raise screening rates to target levels.

Academic Medical Centers↗
PubMed2005

Challenges in systematic reviews of economic analyses.

Economic analyses can provide valuable information for health care decision makers. Systematic reviews of economic analyses can integrate information from multiple studies and provide important insights by systematically examining how differences between models lead to different results. We use our experience in developing and implementing systematic reviews of economic analyses for the U.S. Preventive Services T ask Force, particularly our systematic review of the cost-effectiveness of colorectal cancer screening, to illustrate key methodologic challenges and suggest a framework for other researchers in this area.

Colorectal Neoplasms↗
PubMed2005

Interventions to improve health outcomes for patients with low literacy. A systematic review.

OBJECTIVE: To perform a systematic review of interventions designed to improve health outcomes for persons with low literacy skills. DATA SOURCES: We searched MEDLINE, Cumulative Index to Nursing and Allied Health (CINAHL), Educational Resources Information Center (ERIC), Public Affairs Information Service (PAIS), Industrial and Labor Relations Review (ILLR), PsycInfo, and Ageline from 1980 to 2003. STUDY SELECTION: We included controlled and uncontrolled trials that measured literacy and examined the effect of interventions for people with low literacy on health outcomes, including health knowledge, health behaviors, use of health care resources, intermediate markers of disease status, and measures of morbidity or mortality. Two abstractors reviewed each study for inclusion. Disagreements were resolved by consensus among the research team. DATA EXTRACTION: One reviewer abstracted data from each article into an evidence table; the second reviewer checked each entry. Disagreements about information in evidence tables were resolved by team consensus. Both data extractors independently completed an 11-item quality scale for each article; scores were averaged to give a final measure of article quality. DATA SYNTHESIS: We identified 20 articles examining interventions designed to improve health among people with low literacy. The most common outcome studied was health knowledge; fewer studies examined health behaviors, intermediate markers, or measures of disease prevalence or severity. The effectiveness of interventions appeared mixed. Limitations in research quality and heterogeneity in outcome measures make drawing firm conclusions about effective strategies difficult. Only 5 articles examined the interaction between literacy level and the effect of the intervention; they also found mixed results. CONCLUSIONS: Several interventions have been developed to improve health for people with low literacy. Limitations in study design, interventions tested, and outcomes assessed make drawing conclusions about effectiveness difficult. Further research is required to understand better the types of interventions that are most effective and efficient for overcoming literacy-related barriers to good health.

Clinical Trials as Topic↗
PubMed2004

Influence of patient literacy on the effectiveness of a primary care-based diabetes disease management program.

CONTEXT: Low literacy is an important barrier for patients with diabetes, but interventions to address low literacy have not been well examined. OBJECTIVE: To examine the role of literacy on the effectiveness of a comprehensive disease management program for patients with diabetes. DESIGN, SETTING, AND PARTICIPANTS: Analysis of the influence of literacy on glycemic control and systolic blood pressure using data from a randomized controlled trial (conducted from February 2001 through April 2003) of a comprehensive diabetes management program. Participants were 217 patients aged 18 years or older with type 2 diabetes and poor glycemic control (glycosylated hemoglobin [HbA1c] levels > or =8.0%) and presenting to a US academic general internal medicine practice. INTERVENTIONS: All communication to patients was individualized and delivered to enhance comprehension among patients with low literacy. Intervention patients received intensive disease management from a multidisciplinary team. Control patients received an initial management session and continued with usual care. MAIN OUTCOME MEASURES: Achievement of goal HbA1c levels and systolic blood pressure at 12-month follow-up for control and intervention patients stratified by literacy status. RESULTS: Complete 12-month data were available for 193 patients (89%). Among patients with low literacy, intervention patients were more likely than control patients to achieve goal HbA1c levels (< or =7.0%) (42% vs 15%, respectively; adjusted odds ratio [OR], 4.6; 95% confidence interval [CI], 1.3 to 17.2; P = .02). Patients with higher literacy had similar odds of achieving goal HbA1c levels regardless of intervention status (24% vs 23%; adjusted OR, 1.0; 95% CI, 0.4 to 2.5; P = .98). Improvements in systolic blood pressure were similar by literacy status. CONCLUSIONS: Literacy may be an important factor for predicting who will benefit from an intervention for diabetes management. A diabetes disease management program that addresses literacy may be particularly beneficial for patients with low literacy, and increasing access to such a program could help reduce health disparities.

Academic Medical Centers↗
PubMed2004

What does my patient's coronary artery calcium score mean? Combining information from the coronary artery calcium score with information from conventional risk factors to estimate coronary heart disease risk.

BACKGROUND: The coronary artery calcium (CAC) score is an independent predictor of coronary heart disease. We sought to combine information from the CAC score with information from conventional cardiac risk factors to produce post-test risk estimates, and to determine whether the score may add clinically useful information. METHODS: We measured the independent cross-sectional associations between conventional cardiac risk factors and the CAC score among asymptomatic persons referred for non-contrast electron beam computed tomography. Using the resulting multivariable models and published CAC score-specific relative risk estimates, we estimated post-test coronary heart disease risk in a number of different scenarios. RESULTS: Among 9341 asymptomatic study participants (age 35-88 years, 40% female), we found that conventional coronary heart disease risk factors including age, male sex, self-reported hypertension, diabetes and high cholesterol were independent predictors of the CAC score, and we used the resulting multivariable models for predicting post-test risk in a variety of scenarios. Our models predicted, for example, that a 60-year-old non-smoking non-diabetic women with hypertension and high cholesterol would have a 47% chance of having a CAC score of zero, reducing her 10-year risk estimate from 15% (per Framingham) to 6-9%; if her score were over 100, however (a 17% chance), her risk estimate would be markedly higher (25-51% in 10 years). In low risk scenarios, the CAC score is very likely to be zero or low, and unlikely to change management. CONCLUSION: Combining information from the CAC score with information from conventional risk factors can change assessment of coronary heart disease risk to an extent that may be clinically important, especially when the pre-test 10-year risk estimate is intermediate. The attached spreadsheet makes these calculations easy.

Adult↗
PubMed2004

Using the coronary artery calcium score to predict coronary heart disease events: a systematic review and meta-analysis.

BACKGROUND: Primary prevention of coronary heart disease is most appropriate for patients at relatively high risk. Measurement of coronary artery calcium has been proposed as a way to improve risk assessment, but it is unknown whether it adds predictive information to standard risk factor assessment. METHODS: We systematically searched electronic databases for relevant articles published between January 1, 1980, and March 19, 2003, and hand searched bibliographies. We included studies that reported measuring the coronary artery calcium score by electron beam computed tomography in asymptomatic subjects and subsequent follow-up of those patients for coronary events and that presented score-specific relative risks, adjusted for established risk factors. Two abstractors verified inclusion criteria and abstracted data from each study. We estimated adjusted relative risks associated with 3 standard categories of coronary artery calcium scores (1-100, 101-400, and >400), compared with a score of 0, and used a random-effects model for meta-analysis. RESULTS: Meta-analysis of the 4 studies meeting inclusion criteria yielded a summary adjusted relative risk of 2.1 (95% confidence interval, 1.6-2.9) for a coronary artery calcium score of 1 to 100. Relative risk estimates for higher calcium scores were higher, ranging from 3.0 to 17.0 but varied significantly among studies. Subgroup analyses suggested that differences among studies in outcome adjudication (blinded or not), measurement of other risk factors (direct or by patient history), tomographic slice thickness (3 or 6 mm), and/or proportion of female study subjects may account for this heterogeneity. CONCLUSION: The coronary artery calcium score is an independent predictor of coronary heart disease events.

Humans↗
PubMed2004

Drug treatment of hyperlipidemia in women.

CONTEXT: Several clinical trials have evaluated the effects of lipid-lowering medications on coronary heart disease (CHD). Many of the trials have not included enough women to allow sex-specific analyses or have not reported results in women separately. OBJECTIVES: To assess and synthesize the evidence regarding drug treatment of hyperlipidemia for the prevention of CHD events in women and to conduct a meta-analysis of the effect of drug treatment on mortality. DATA SOURCES: We searched MEDLINE, the Cochrane Database, and the Database of Abstracts of Reviews of Effectiveness for articles published from 1966 through December 2003. We reviewed reference lists of articles and consulted content experts. STUDY SELECTION AND DATA EXTRACTION: Studies of outpatients that had a treatment duration of at least 1 year, assessed the impact of lipid lowering on clinical outcomes, and reported results by sex were included. Outcomes evaluated were total mortality, CHD mortality, nonfatal myocardial infarction, revascularization, and total CHD events. Summary estimates of the relative risks (RRs) with therapy were calculated using a random-effects model for patients with and without a previous history of cardiovascular disease. DATA SYNTHESIS: Thirteen studies were included. Six trials included a total of 11 435 women without cardiovascular disease and assessed the effects of lipid-lowering medications. Lipid lowering did not reduce total mortality (RR, 0.95; 95% confidence interval [CI], 0.62-1.46), CHD mortality (RR, 1.07; 95% CI, 0.47-2.40), nonfatal myocardial infarction (RR, 0.61; 95% CI, 0.22-1.68), revascularization (RR, 0.87; 95% CI, 0.33-2.31), or CHD events (RR, 0.87; 95% CI, 0.69-1.09). However, some analyses were limited by too few CHD events in the available trials. Eight trials included 8272 women with cardiovascular disease and assessed the effects of lipid-lowering medications. Lipid lowering did not reduce total mortality in women with cardiovascular disease (RR, 1.00; 95% CI, 0.77-1.29). However, lipid lowering reduced CHD mortality (RR, 0.74; 95% CI, 0.55-1.00), nonfatal myocardial infarction (RR, 0.71; 95% CI, 0.58-0.87), revascularization (RR, 0.70; 95% CI, 0.55-0.89), and total CHD events (RR, 0.80; CI, 0.71-0.91). CONCLUSIONS: For women without cardiovascular disease, lipid lowering does not affect total or CHD mortality. Lipid lowering may reduce CHD events, but current evidence is insufficient to determine this conclusively. For women with known cardiovascular disease, treatment of hyperlipidemia is effective in reducing CHD events, CHD mortality, nonfatal myocardial infarction, and revascularization, but it does not affect total mortality.

Coronary Disease↗
PubMed2004

Exercise tolerance testing to screen for coronary heart disease: a systematic review for the technical support for the U.S. Preventive Services Task Force.

BACKGROUND: Coronary heart disease is the leading cause of morbidity and mortality in the United States. Exercise tolerance testing has been proposed as a means of better identifying asymptomatic patients at high risk for coronary heart disease events. PURPOSE: To review the evidence on the use of exercise tolerance testing to screen adults with no history of cardiovascular disease for coronary heart disease. DATA SOURCES: The MEDLINE database from 1966 through February 2003, hand-searching of bibliographies, and expert input. STUDY SELECTION: Eligible studies evaluated the benefits or harms of exercise tolerance testing when added to traditional risk assessment for adults with no known history of cardiovascular events. DATA EXTRACTION: One reviewer extracted information from eligible articles into evidence tables, and another reviewer checked the tables. Disagreements were resolved by consensus. DATA SYNTHESIS: No study has directly examined the effect of screening asymptomatic patients with exercise tolerance testing on coronary heart disease outcomes or risk-reducing behaviors or therapies. Multiple cohort studies demonstrate that screening exercise tolerance testing identifies a small proportion of asymptomatic persons (up to 2.7% of those screened) with severe coronary artery obstruction who may benefit from revascularization. Several large prospective cohort studies, conducted principally in middle-aged men, suggest that exercise tolerance testing can provide independent prognostic information about the risk for future coronary heart disease events (relative risk with abnormal exercise tolerance testing, 2.0 to 5.0). However, when the risk for coronary heart disease events is low, most positive findings will be false and may result in unnecessary further testing or worry. The risk level at which the benefits of additional prognostic information outweigh the harms of false-positive results is unclear and requires further study. CONCLUSIONS: Although screening exercise tolerance testing detects severe coronary artery obstruction in a small proportion of persons screened and can provide independent prognostic information about the risk for coronary heart disease events, the effect of this information on clinical management and disease outcomes in asymptomatic patients is unclear.

Coronary Disease↗
PubMed2004

Development and pilot testing of a disease management program for low literacy patients with heart failure.

UNLABELLED: Development and pilot testing of a disease management program for low literacy patients with heart failure. BACKGROUND: Randomized trials have shown that disease management programs can reduce hospitalizations and improve symptoms for patients with congestive heart failure. We sought to create and pilot test such a program for patients with low literacy skills. METHODS: We used focus groups and individual cognitive response interviews (CRIs) to develop an educational booklet for low literacy patients with heart failure. We incorporated the booklet into a disease management intervention that also included an initial individualized 1-h educational session and scheduled supportive phone calls that were tapered over 6 weeks. We then conducted a 3-month before-after study on patients with low literacy skills (<9th grade literacy level) in a university internal medicine clinic to test the acceptability and efficacy of our program. Outcomes of interest included heart failure-related knowledge, self-care behavior and heart failure-related symptoms measured on the Minnesota Living with Heart Failure (MLwHF) scale. RESULTS: Twenty-five patients were enrolled and 23 (92%) completed 3-month follow-up. Mean age was 60 years (range 35-74), 60% were men, 60% were African-American, and 74% had household income under $15,000 per year. The median reading level was fifth grade with 32% reading at or below the third grade level. Mean knowledge score at baseline was 67% and did not improve after the intervention. The proportion of patients reporting weighing themselves daily increased from 32% at baseline to 100% at 12 weeks. Mean improvement on the MLwHF scale was 9.9 points over the 3-month trial (95% CI: 0.5, 19.2), which corresponds to an improvement in one class on the New York Heart Association heart failure scale. CONCLUSION: A heart failure disease management program designed specifically for patients with low literacy skills is acceptable and is associated with improvement in self-care behavior and heart failure related symptoms.

Adult↗