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Biomedical subjects

Kevin P Weinfurt

Publications and source records attributed to Kevin P Weinfurt.

At least 19 recordsLinked to original sources
PubMed2007

Value of high-cost cancer care: a behavioral science perspective.

Concerns about the high costs of cancer care have led to a renewed interest in understanding how patients value the outcomes of care. Psychologists, economists, and others have highlighted some of the ways in which patients and caregivers perceive and make treatment decisions. Prospect theory is the predominant framework for understanding decisions made in situations where the outcomes of each choice are uncertain. Prospect theory assumes that a patient values the outcomes of care not in absolute terms, such as years of life saved, but as deviations from the patient's point of reference. This article discusses some of the implications of this notion, along with discussing differences among people in their reference points. These and other considerations from the psychology of decision making help to clarify why some patients might be inclined to seek expensive or risky treatments in the hopes of achieving benefits that others might consider not worthwhile. An appreciation of these psychological issues might improve the quality of debates concerning the rising costs of cancer care.

Behavioral Sciences↗
PubMed2006

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

PURPOSE: To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. METHOD: The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. RESULTS: Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant. CONCLUSIONS: Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

Academic Medical Centers↗
PubMed2006

Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure.

BACKGROUND: There is little guidance regarding how to disclose researchers' financial interests to potential research participants. OBJECTIVE: To determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement. DESIGN AND PARTICIPANTS: Sixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer. APPROACH: Focus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis. RESULTS: Participants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know. CONCLUSIONS: Financial interests are important to potential research participants, but obstacles to effective disclosure exist.

Adolescent↗
PubMed2006

Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators.

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.

Attitude of Health Personnel↗
PubMed2006

Racial differences in health concern.

An understanding of racial differences in risk-related affect may help explain racial differences in health behaviors and outcomes and provide additional opportunities for intervention. In phone interviews with a random community sample of 197 whites, 155 blacks and 163 Latinos, we assessed concern that respondents' health would be hurt by their diet, an inability to exercise, an inability to follow a doctor's recommendations and disease. A multivariate analysis of variance with follow-up profile analysis revealed that whites were less concerned than blacks and Latinos about an inability to follow their doctors' recommendations (ps < 0.01). There were no racial differences in the other health concern variables. Interventions to inform blacks and Latinos about their health risks must strike a balance between creating enough health concern to encourage health behavior but not so much that it interferes with health-promoting behaviors.

Adolescent↗
PubMed2005

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials.

BACKGROUND: There is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials. METHODS: Surveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency-type numeracy was assessed using a multiple-choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in "40% of cases like yours." In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified. RESULTS: The correct frequency-type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief-type answer, "The doctor is 40% confident that the treatment will control my cancer." In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies. CONCLUSIONS: Because the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment.

Adult↗
PubMed2005

Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT).

BACKGROUND: In a multinational clinical trial, valsartan was statistically not inferior to captopril in reducing mortality and cardiovascular morbidity after myocardial infarction (MI) in patients with signs of heart failure and/or left ventricular dysfunction. We conducted a prospective economic evaluation to compare within-trial resource use, costs, and quality of life in patients receiving valsartan, captopril, or both after MI. METHODS: We assigned country-specific unit costs to resource use data for 14703 patients and measured health-related quality of life in a subset of 4524 patients. We used the nonparametric bootstrap method to compare rates of resource use and costs, and a piecewise linear mixed-effects regression analysis to compare longitudinal measures of quality of life. RESULTS: There were no significant differences in rates of resource use between the valsartan and captopril groups. During an average follow-up of 2 years, total costs for patients receiving valsartan were significantly higher than for patients receiving captopril (USD 14103 vs USD 13038; 95% CI USD 369-USD 1875). The cost differential was caused primarily by the cost of the study medications (USD 1056 for valsartan vs USD 165 for captopril; 95% CI USD 867 to USD 912). Quality of life did not differ significantly between groups. CONCLUSIONS: For most patients at high risk after MI, the availability of generic captopril confers a cost advantage over valsartan because of lower medication costs. The difference will be smaller or nonexistent in settings where brand-name ACE inhibitors are prescribed.

Ambulatory Care↗
PubMed2005

Performance of the Thrombolysis in Myocardial Infarction (TIMI) ST-elevation myocardial infarction risk score in a national cohort of elderly patients.

BACKGROUND: The TIMI ST-elevation myocardial infarction (STEMI) score was developed and validated in a randomized controlled trial population. We sought to assess its accuracy in a community-based cohort of elderly patients hospitalized with STEMI. METHODS: We evaluated the TIMI STEMI score in 47,882 patients aged > or = 65 years hospitalized with STEMI in US hospitals from 1994 to 1996. We assessed TIMI STEMI score discrimination and calibration for 30-day mortality and compared observed and published TIMI mortality rates. RESULTS: The cohort's median TIMI score was 6 (25th-75th percentile 4, 8). Thirty-day mortality rates were higher among patients with higher TIMI scores (TIMI score 2: 4.4% vs TIMI score > 8: 35.6%, P < .0001 for trend). However, the TIMI score provided only modest discrimination (c = 0.67) and calibration (goodness-of-fit P < .0001). Mortality rates for TIMI scores differed between patients who did and did not receive reperfusion therapy (P < .0001 for TIMI score x reperfusion therapy interaction). Thirty-day mortality rates in the cohort were higher than published TIMI estimates (P = .001; eg, TIMI score 2: 4.4% cohort vs 2.2% published rate). CONCLUSIONS: The TIMI score provided modest prognostic discrimination and calibration among elderly patients with STEMI. Our findings highlight the difficulties in applying risk scores developed in randomized controlled trial cohorts to elderly patients.

Aged↗
PubMed2005

Perceived discrimination and reported delay of pharmacy prescriptions and medical tests.

BACKGROUND: Access to health care varies according to a person's race and ethnicity. Delaying treatment is one measure of access with important health consequences. OBJECTIVE: Determine whether perceptions of unfair treatment because of race or ethnicity are associated with reported treatment delays, controlling for economic constraints, self-reported health, depression, and demographics. DESIGN: Cross-sectional, observational study. PARTICIPANTS: A randomly selected community sample of 181 blacks, 148 Latinos, and 193 whites in Durham County, NC. MEASUREMENTS: A phone survey conducted in 2002 to assess discrimination, trust in medical care, quality of care, and access to care. Treatment delays were measured by whether or not a person reported delaying or forgoing filling a prescription and delaying or forgoing having a medical test/treatment in the past 12 months. Perceived discrimination was measured as unfair treatment in health care and as racism in local health care institutions. RESULTS: The odds of delaying filling prescriptions were significantly higher (odds ratio (OR)=2.02) for persons who perceived unfair treatment, whereas the odds of delaying tests or treatments were significantly higher (OR=2.42) for persons who thought racism was a problem in health care locally. People with self-reported depression and people who reported not working had greater odds of delaying both types of care. CONCLUSIONS: A prospective cohort study with both personal and macro measures of discrimination, as well as more refined measures of treatment delays, would help us better understand the relationship between perceived discrimination and treatment delays.

Adult↗
PubMed2005

Who trusts healthcare institutions? Results from a community-based sample.

OBJECTIVE: The goal of this research was to examine racial differences in trust in various healthcare institutions. METHOD: In telephone interviews, 195 Whites, 183 Blacks, and 171 Latinos from Durham, NC indicated how often they trust various institutions (community doctors, local hospitals, county health department, insurance companies, and state and federal government) to do what is best for patients. RESULTS: In bivariate analyses, trust in various healthcare institutions was associated with race; Whites and Latinos trusted physicians more often than Blacks, and Latinos trusted the health department, insurance companies, and both government entities more often than Whites and Blacks (Ps < .01). In adjusted analyses controlling for marital status, financial status, and education, race was still associated with trust. Whites trusted physicians more often than Blacks, and Latinos trusted insurance companies, the state government, and the federal government more often than Whites and Blacks (Ps < .01). CONCLUSIONS: Racial differences in trust of healthcare institutions vary by institution type. Future studies of trust and interventions designed to improve trust must account for race and target institution differences.

Adult↗
PubMed2004

Parents' reported preference scores for childhood atopic dermatitis disease states.

BACKGROUND: We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic dermatitis would assign different preferences to the health state scenarios compared with parents who did not have a child with atopic dermatitis. METHODS: Subjects were parents of children aged 3 months to 18 years. The sample was derived from the General Panel, Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris Interactive. Participants rated health scenarios for atopic dermatitis, asthma, and eyeglasses on a visual analog scale, imagining a child was experiencing the described state. RESULTS: A total of 3539 parents completed the survey. Twenty-nine percent had a child with a history of atopic dermatitis. Mean preference scores for atopic dermatitis were as follows: mild, 91 (95% confidence interval [CI], 90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4); moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61 (95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1); asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI, 86.3 to 87.4). CONCLUSIONS: Parents perceive that atopic dermatitis has a negative effect on quality of life that increases with disease severity. Estimates of parents' preferences can provide physicians with insight into the value that parents place on their children's treatment and can be used to evaluate new medical therapies for atopic dermatitis.

Adolescent↗
PubMed2004

Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions.

BACKGROUND: Research on individual differences in health-related quality of life (HRQOL) can identify intervention targets and important covariates in analyses of treatment outcomes. OBJECTIVES: The objectives of this study were to describe HRQOL trajectories for women with metastatic breast cancer in a randomized trial of bisphosphonates and to identify characteristics associated with variations in HRQOL. RESEARCH DESIGN: We conducted a prospective quality-of-life study within a randomized, controlled trial. SUBJECTS: We studied women with metastatic breast cancer receiving zoledronic acid or pamidronate disodium to reduce the incidence of skeletal-related events (SREs). MAIN OUTCOME MEASURES: HRQOL was measured at fixed time points during the trial. Individual growth-curve modeling was used to describe longitudinal trajectories and to identify predictors of trajectories. RESULTS: For most domains of HRQOL, the mean trajectory reflected a mild increase, which leveled off later in the trial. Older age and full-time employment were associated with higher baseline HRQOL. Longer time from cancer diagnosis to randomization, lower Eastern Cooperative Oncology Group (ECOG) status (score of 2 ["inactive"]), and a history of SREs were associated with lower baseline HRQOL. Significant differences across geographic regions were observed for all domains. Active ECOG status (score of 0-1) at baseline was predictive of greater increases in all domains of HRQOL except Social/Family Well-Being. Age, geographic region, and time from first bone metastases to randomization were associated with longitudinal changes in some domains. CONCLUSIONS: Women with metastatic breast cancer receiving bisphosphonates for prevention of SREs experienced an overall increase in HRQOL. Variations among women's experiences are explained partly by such characteristics as a history of SREs.

Bone Neoplasms↗
PubMed2003

The correlation between patient characteristics and expectations of benefit from Phase I clinical trials.

BACKGROUND: Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials. METHODS: Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data. RESULTS: Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy. CONCLUSIONS: Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.

Adult↗
PubMed2003

Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication.

PURPOSE: To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials. METHODS: Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient's physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations. RESULTS: Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P <.0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P <.0001). CONCLUSION: Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients' stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.

Adult↗
PubMed2003

Validity of a simple ST-elevation acute myocardial infarction risk index: are randomized trial prognostic estimates generalizable to elderly patients?

BACKGROUND: Risk-stratification scores derived from randomized clinical trial (RCT) data should be evaluated in community-based populations. A simple risk-stratification index for patients with ST-segment elevation myocardial infarction derived from an RCT population was recently proposed, but it has not been validated in a community-based cohort. METHODS AND RESULTS: We evaluated the simple risk index using data from 49 711 patients > or =65 years of age hospitalized with ST-elevation myocardial infarction. We evaluated the distribution of patients in the 5 simple risk index groups, compared observed and published 30-day mortality rates, and assessed the score's discrimination and calibration. The simple risk index provided poor discrimination (c=0.62) and calibration (goodness of fit P<0.001) for survival at 30 days. Risk score distribution was skewed, because two thirds (66.1%) of all patients were classified in the highest-risk group, whereas fewer than 11.0% were classified in the 3 lowest-risk groups. Thirty-day mortality estimates were lower than those observed in the cohort (risk group 2 to 5: 1.9% to 17.4% versus 5.3% to 27.9%). Risk index discrimination, calibration, score distribution, and mortality estimates were worse among patients who did not receive acute reperfusion therapy than among those who did. CONCLUSIONS: The limited performance of the simple risk index highlights the limitations of applying prognostic models derived in RCT populations to the general population of patients 65 years and older. Prognostic scores must be validated in community-based cohorts before integration into clinical practice.

Aged↗
PubMed2003

Outcomes research related to patient decision making in oncology.

For outcomes research, what are the implications of seeing the patient as a decision maker? In the current medical environment, greater emphasis is placed on the role played by the patient in clinical decision making. In the past 2 decades, considerable work has been done to identify and measure decision-related outcomes, including knowledge about the treatment options (risks and benefits), satisfaction, anxiety, decisional conflict, and involvement in the decision process. Attempts to improve these decision-related outcomes involve patient decision aids, which convey patient-specific information and sometimes help patients proceed through an explicit decision-making process. These interventions have produced positive results, especially with respect to improving patient knowledge. Future research is needed to understand which aspects of the interventions work and for what types of patients. Research is also needed to better understand the decision making process of patients who do not use decision aids.

Decision Making↗
PubMed2002

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

BACKGROUND: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards. METHODS: From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials. RESULTS: Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items. CONCLUSIONS: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.

Clinical Trials as Topic↗