Improving the quality of mental health care in multiple sclerosis.

OBJECTIVE: An exploratory study of mental health treatment of people with multiple sclerosis (MS) to identify hypotheses for future testing. METHODS: We mailed surveys to 8750 MS patients in four geographically distributed MS Centers; 3384 completed the survey. We used a modified version of the Experience of Care and Health Outcome Survey™ to assess mental health problems and experiences with mental health treatment and the Kessler 6 scale to identify serious mental illness. RESULTS: In the year before the survey, sixty percent of patients reported mental health problems. Less than one half of these individuals received mental health treatment, either from their MS care provider or a mental health professional in the MS Center or the community. Patients generally had good mental health treatment experiences, and felt helped by their treatment, but gave less positive reports about how long it took to be seen, receiving information about treatment options and managing their condition, and phone contact. Care experiences were more positive among those who received care from mental health professionals (compared to medical care providers) and among those receiving mental health treatment in the MS Center (compared to in the community). CONCLUSIONS: The unmet need for mental health treatment for people with MS is high. Options for MS care providers to help meet this need include hiring mental health professionals to provide on-site treatment; providing mental health treatment themselves; and referring patients to mental health professionals in the community and collaborating in integrated care. This study provided preliminary data for two related hypotheses that warrant further testing: MS patients will receive better mental health care if their mental health treatment is co-located with their MS care and if it is provided by mental health professionals.

The quality of care received by HIV patients without a primary provider.

The goal of this study was to compare the quality of care received by HIV patients who report that their primary HIV care provider is a physician, a nurse practitioner (NP) or a physician assistant (PA) to that of patients who cannot identify a primary HIV provider. We used data from patients who participated in the HIV Cost and Services Utilization Study (HCSUS), a study of a probability sample of non-institutionalized HIV-infected individuals in care in the US. We compared patients who did and did not name a primary HIV care provider in terms of patient and care site characteristics, and level of clinician HIV expertise. Care quality measures included receipt of highly active antiretroviral therapy (HAART), reported problems with care, satisfaction with care, unmet needs and perceived access to care. Patients in care who did not report having a primary HIV care provider received HAART at significantly lower rates (p<0.05) and were less satisfied with their care (p<0.05) than patients with a primary HIV care provider, after adjusting for illness severity and other patient characteristics. There were similar but non-significant trends for reported problems, unmet needs and perceived access to care. Patients who had lower income or were drug users were more likely not to have a primary provider. We conclude that having a primary HIV care provider who is knowledgeable about a patient's care is related to the quality of medical care received by persons with HIV infection.

Hearing the patient's voice? Factors affecting the use of patient survey data in quality improvement.

OBJECTIVE: To develop a framework for understanding factors affecting the use of patient survey data in quality improvement. DESIGN: Qualitative interviews with senior health professionals and managers and a review of the literature. SETTING: A quality improvement collaborative in Minnesota, USA involving teams from eight medical groups, focusing on how to use patient survey data to improve patient centred care. PARTICIPANTS: Eight team leaders (medical, clinical improvement or service quality directors) and six team members (clinical improvement coordinators and managers). RESULTS: Respondents reported three types of barriers before the collaborative: organisational, professional and data related. Organisational barriers included lack of supporting values for patient centred care, competing priorities, and lack of an effective quality improvement infrastructure. Professional barriers included clinicians and staff not being used to focusing on patient interaction as a quality issue, individuals not necessarily having been selected, trained or supported to provide patient centred care, and scepticism, defensiveness or resistance to change following feedback. Data related barriers included lack of expertise with survey data, lack of timely and specific results, uncertainty over the effective interventions or time frames for improvement, and consequent risk of perceived low cost effectiveness of data collection. Factors that appeared to have promoted data use included board led strategies to change culture and create quality improvement forums, leadership from senior physicians and managers, and the persistence of quality improvement staff over several years in demonstrating change in other areas. CONCLUSION: Using patient survey data may require a more concerted effort than for other clinical data. Organisations may need to develop cultures that support patient centred care, quality improvement capacity, and to align professional receptiveness and leadership with technical expertise with the data.

Religiousness and spirituality among HIV-infected Americans.

PURPOSE: To describe the demographic and clinical factors associated with the importance of religiousness and spirituality among patients with human immunodeficiency virus (HIV) infection in the United States. METHODS: Longitudinal study of a nationally representative cohort of 2266 patients receiving care for HIV infection surveyed in 1996 and again in 1998. Measures included 12 items assessing religious affiliation and attendance, the importance of religion and spirituality in life, and religious and spiritual practices. Multi-item religiousness and spirituality scales were constructed. RESULTS: Eighty percent of respondents reported a religious affiliation. Sixty-five percent affirmed that religion and 85% that spirituality was "somewhat" or "very" important in their lives. A majority indicated that they "sometimes" or "often" rely on religious or spiritual means when making decisions (72%) or confronting problems (65%). Women, nonwhites, and older patients were more religious and spiritual. Residents of regions other than the western United States reported higher religiousness. High school graduates were more religious and spiritual than those with less education. Patients who did not report one of the risk factors assessed for HIV infection had higher religiousness scores than injection drug users (IDUs). Women, nonwhites other than Hispanics, patients older than 45 years of age compared to those between 18 and 34 years of age, and more educated patients reported higher spirituality. Clinical stage was not associated with religiousness or spirituality. CONCLUSIONS: A large majority of HIV-infected patients in the United States affirm the importance of religiousness and spirituality. These findings support a comprehensive, humanistic approach to the care of HIV-infected patients.

Differences in patient and clinic characteristics at CARE Act funded versus non-CARE Act funded HIV clinics.

The Ryan White CARE Act supports comprehensive care to persons with HIV infection. With an annual budget of over $1 billion, it is the largest federally funded programme for HIV care in the USA. We analysed data from the HIV Costs and Services Utilization Study, a nationally representative sample of HIV patients. Patient data were collected in 1996-97 and clinic data were collected in 1998-99. We examined whether CARE Act funded clinics differed from other HIV clinics in (1) the characteristics of their patients, and (2) their organization, staffing, and services. We found that patients at CARE Act clinics were younger, less educated, poorer, and more likely to be female, non-white, unemployed, uninsured, and have heterosexual contact as an HIV risk factor, compared to patients at other HIV clinics. CARE Act clinics tended to specialize in HIV care, had more infectious disease specialists, had fewer total patients, and provided more support services (e.g. mental health, nutrition, case management, child care). These results are consistent with findings of other studies that were limited by non-probability samples or restricted geographical areas.

What do patients value in their hospital care? An empirical perspective on autonomy centred bioethics.

OBJECTIVE: Contemporary ethical accounts of the patient-provider relationship emphasise respect for patient autonomy and shared decision making. We sought to examine the relative influence of involvement in decisions, confidence and trust in providers, and treatment with respect and dignity on patients' evaluations of their hospital care. DESIGN: Cross-sectional survey. SETTING: Fifty one hospitals in Massachusetts. PARTICIPANTS: Stratified random sample of adults (N=27 414) discharged from a medical, surgical, or maternity hospitalisation between January and March, 1998. Twelve thousand six hundred and eighty survey recipients responded. MAIN OUTCOME MEASURE: Respondent would definitely be willing to recommend the hospital to family and friends. RESULTS: In a logistic regression analysis, treatment with respect and dignity (odds ratio (OR) 3.4, 99% confidence interval (CI) 2.8 to 4.2) and confidence and trust in providers (OR 2.5, CI 2.1 to 3.0) were more strongly associated with willingness to recommend than having enough involvement in decisions (OR 1.4, CI 1.1 to 1.6). Courtesy and availability of staff (OR 2.5, CI 2.1 to 3.1), continuity and transition (OR 1.9, CI 1.5 to 2.2), attention to physical comfort (OR 1.8, CI 1.5 to 2.2), and coordination of care (OR 1.5, CI 1.3 to 1.8) were also significantly associated with willingness to recommend. CONCLUSIONS: Confidence and trust in providers and treatment with respect and dignity are more closely associated with patients' overall evaluations of their hospitals than adequate involvement in decisions. These findings challenge a narrow emphasis on patient autonomy and shared decision making, while arguing for increased attention to trust and respect in ethical models of health care.

Quality of informed consent in cancer clinical trials: a cross-sectional survey.

BACKGROUND: Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. METHODS: We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. FINDINGS: 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. INTERPRETATION: Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.

National quality monitoring of Medicare health plans: the relationship between enrollees' reports and the quality of clinical care.

BACKGROUND: The clinical quality of health plans varies. The associations between different measures of health plan quality are incompletely understood. OBJECTIVE: To assess the relationships between enrollee reports on the quality of health plans as measured by the Consumer Assessment of Health Plans Study (CAHPS 2.0) survey and the clinical quality of care measured by the Medicare Health Plan Employer Data and Information Set (HEDIS). DESIGN: Observational cohort study. SAMPLE: National sample of 233 Medicare health plans that reported data using the CAHPS 2.0 survey and Medicare HEDIS during 1998. MEASURES: Five composite measures and four ratings derived from the CAHPS survey and six measures of clinical quality from Medicare HEDIS. RESULTS: Two composite measures ("getting needed care" and "health plan information and customer service") were significantly associated with most of the HEDIS clinical quality measures. The proportion of enrollees having a personal doctor was also significantly associated with rates of mammography, eye exams for diabetics, beta-blocker use after myocardial infarction, and follow-up after mental health hospitalization. Enrollees' ratings of health plan care were less consistently associated with HEDIS performance. In multivariable analyses, the measure of health plan communication ("health plan information and customer service") was the most consistent predictor of HEDIS performance. CONCLUSIONS: The pattern of associations we observed among some of the measures suggests that the CAHPS survey and HEDIS are complementary quality monitoring strategies. Our results suggest that health plans that provide better access and customer service also provide better clinical care.

Patients' experiences with hospital care in five countries.

Analysis of patient surveys carried out in Germany, Sweden, Switzerland, the United Kingdom, and the United States in 1998-2000 revealed high rates of problems during inpatient hospital stays. Problems with information and education, coordination of care, respect for patients' preferences, emotional support, physical comfort, involvement of family and friends, and continuity and transition were prevalent in all five countries. These dimensions of patients' experience appear to be salient and relevant in each of the five countries, but attempts to develop international rankings based on this type of evidence will have to overcome a number of methodological problems.

Racial disparity in influenza vaccination: does managed care narrow the gap between African Americans and whites?

CONTEXT: Substantial racial disparities exist in use of some health services. Whether managed care could reduce racial disparities in the use of preventive services is not known. OBJECTIVE: To determine whether the magnitude of racial disparity in influenza vaccination is smaller among managed care enrollees than among those with fee-for-service insurance. DESIGN, SETTING, AND PARTICIPANTS: The 1996 Medicare Current Beneficiary Survey of a US cohort of 13 674 African American and white Medicare beneficiaries with managed care and fee-for-service insurance. MAIN OUTCOME MEASURES: Percentage of respondents (adjusted for sociodemographic characteristics, clinical comorbid conditions, and care-seeking attitudes) who received influenza vaccination and magnitude of racial disparity in influenza vaccination, compared among those with managed care and fee-for-service insurance. RESULTS: Eight percent of the beneficiaries were African American and 11% were enrolled in managed care. Overall, 65.8% received influenza vaccination. Whites were substantially more likely to be vaccinated than African Americans (67.7% vs 46.1%; absolute disparity, 21.6%; 95% confidence interval [CI], 18.2%-25.0%). Managed care enrollees were more likely than those with fee-for-service insurance to receive influenza vaccination (71.2% vs 65.4%; difference, 5.8%; 95% CI, 3.6%-8.3%). The adjusted racial disparity in fee-for-service was 24.9% (95% CI, 19.6%-30.1%) and in managed care was 18.6% (95% CI, 9.8%-27.4%). These adjusted racial disparities were both statistically significant, but the absolute percentage point difference in racial disparity between the 2 insurance groups (6.3%; 95% CI, -4.6% to 17.2%) was not. CONCLUSION: Managed care is associated with higher rates of influenza vaccination for both whites and African Americans, but racial disparity in vaccination is not reduced in managed care. Our results suggest that additional efforts are needed to adequately address this disparity.

Toward a national consumer survey: evaluation of the CABHS and MHSIP instruments.

This article describes a study evaluating the Consumer Assessment of Behavioral Health Survey (CABHS) and the Mental Health Statistics Improvement Program (MHSIP) surveys. The purpose of the study was to provide data that could be used to develop recommendations for an improved instrument. Subjects were 3,443 adults in six behavioral health plans. The surveys did not differ significantly in response rate or consumer burden. Both surveys reliably assessed access to treatment and aspects of appropriateness and quality. The CABHS survey reliably assessed features of the insurance plan; the MHSIP survey reliably assessed treatment outcome. Analyses of comparable items suggested which survey items had greater validity. Results are discussed in terms of consistency with earlier research using these and other consumer surveys. Implications and recommendations for survey development, quality improvement, and national policy initiatives to evaluate health plan performance are presented.

Quality of ambulatory care after myocardial infarction among Medicare patients by type of insurance and region.

PURPOSE: To evaluate use of effective cardiac medications and rehabilitation after myocardial infarction in the ambulatory setting in health maintenance organizations (HMOs) and fee-for-service care, and by region. SUBJECTS AND METHODS: We surveyed elderly Medicare patients during 1996 and 1997 in California (n = 516), Florida (n = 304), and the Northeast (n = 220; Massachusetts, New York, and Pennsylvania) approximately 18 months after myocardial infarction. We assessed use of cardiac medications and rehabilitation for HMO (n = 520) and fee-for-service (n = 520) patients matched by age, sex, month of infarct, and region. RESULTS: Across all regions, similar proportions of HMO and fee-for-service patients were using aspirin (72%, n = 374 vs. 74%, n = 387), beta-blockers (38%, n = 195 vs. 32%, n = 168), angiotensin-converting enzyme inhibitors (31%, n = 159 vs. 29%, n = 148), cholesterol-lowering agents (28%, n = 146 vs. 30%, n = 157), and calcium channel blockers (31%, n = 162 vs. 31%, n = 159; all P >0.07), except in California where more HMO patients received beta-blockers (36%, n = 93 vs. 26%, n = 66, P = 0.01). In adjusted analyses, use of these drugs did not differ significantly between HMO and fee-for-service patients. Substantial regional differences were evident in the use of beta-blockers (Northeast 46%, n = 102; Florida 34%, n = 102; California 31%, n = 159) and cholesterol-lowering agents (California 35%, n = 182; Florida 24%, n = 73; Northeast 22%, n = 48; each P <0.001). Fee-for-service patients were more likely than HMO patients to receive cardiac rehabilitation in unadjusted (32%, n = 167, vs. 22%, n = 141, P = 0.001) and adjusted analyses. CONCLUSIONS: Both HMO and fee-for-service patients would likely benefit from greater use of beta-blockers and cholesterol-lowering agents. Professional fees for cardiac rehabilitation may promote increased use among fee-for-service patients. Future studies should assess the quality of ambulatory cardiac care in different types of HMOs and the reasons for geographic variations in cardiac drug use.

Adjusting for patient characteristics when analyzing reports from patients about hospital care.

OBJECTIVES: To determine which patient characteristics are associated with reports and ratings of hospital care, and to evaluate how adjusting reports and ratings for hospital differences in such variables affects comparisons among hospitals. DESIGN: A telephone survey of a sample of patients hospitalized in 22 hospitals in a single city and a statewide mail survey of hospitalized patients. MEASURES: The surveys assessed: respect for patients' preferences, coordination of care, information exchange between patient and providers, physical care, emotional support, involvement of family and friends, and transition and continuity. The surveys also asked patients to rate their doctors, nurses, and other hospital staff. RESULTS: The variables with the strongest and most consistent associations with patient-reported problems were age and reported health status. Patient gender and education level also sometimes predicted reports and/or ratings. Models including these variables explained only between 3% and 8% of the variation in reports and ratings. CONCLUSIONS: The impact of adjusting for patient characteristics on hospital rankings was small, although a larger impact would be expected when comparing hospitals with more variability in types of patients. Nevertheless, we recommend adjusting at least for the most important predictors, such as age and health status. Such adjustment helps alleviate concerns about bias. It also may be useful to present data for certain groups of patients (ie, medical, surgical, obstetric) separately to facilitate interpretation and quality improvement efforts.

Detecting suicide risk in a pediatric emergency department: development of a brief screening tool.

OBJECTIVE: To develop a brief screening tool that will allow emergency department (ED) staff to rapidly and accurately detect suicide risk in child and adolescent patients. DESIGN: Cross-sectional survey. Participants. One hundred forty-four children and adolescents, mean age of 13.6 years, presenting to an urban university teaching hospital pediatric ED for primarily psychiatric reasons. Data Collection. As part of a quality improvement initiative, we developed a 14-item screening survey (the Risk of Suicide Questionnaire [RSQ]) that was administered by a triage nurse to all pediatric mental health patients on admission to the ED. All patients were subsequently administered the 30-item Suicide Ideation Questionnaire (SIQ) by a mental health clinician, which served as the criterion standard assessment of suicidality. Other information collected included demographic and clinical characteristics. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive predictive value, negative predictive value (NPV), and area under the receiver operating characteristic curve for responses to individual and combinations of RSQ items, relative to determinations of suicidality by the criterion standard SIQ. RESULTS: Four of the items from the RSQ had a predictive c statistic of 0.87, a sensitivity of 0.98, and a NPV of 0.97. Little improvement in predictive ability was obtained by including other RSQ items (c statistic for the most predictive 4-item model = 0.87; c statistic for the model containing all 14 items = 0.90). Among all possible combinations of 4 RSQ items, the combination of items inquiring about current suicidal behavior, past suicidal ideation, past self-destructive behavior, and current stressors yielded the highest sensitivity (0.98), NPV (0.97), and c statistic (0.87), as assessed by the criterion standard SIQ. CONCLUSIONS: A brief 4-item screening tool can be used by nonmental health clinicians to accurately detect suicidality in children and adolescents who visit an ED. Early and accurate identification of suicidality is a critical first step that could lead to better treatment and improved health outcomes for children and adolescents with mental health concerns.

Physician incentives and disclosure of payment methods to patients.

OBJECTIVE: There is increasing public discussion of the value of disclosing how physicians are paid. However, little is known about patients' awareness of and interest in physician payment information or its potential impact on patients' evaluation of their care. DESIGN: Cross-sectional survey SETTING: Managed care and indemnity plans of a large, national health insurer. PARTICIPANTS: Telephone interviews were conducted with 2,086 adult patients in Atlanta, Ga; Baltimore, Md/Washington DC; and Orlando, Fla (response rate, 54%). MEASUREMENTS AND MAIN RESULTS: Patients were interviewed to assess perceptions of their physicians' payment method, preference for disclosure, and perceived effect of different financial incentives on quality of care. Non-managed fee-for-service patients (44%) were more likely to correctly identify how their physicians were paid than those with salaried (32%) or capitated (16%) physicians. Just over half (54%) wanted to be informed about their physicians' payment METHOD: Patients of capitated and salaried physicians were as likely to want disclosure as patients of fee-for-service physicians. College graduates were more likely to prefer disclosure than other patients. Many patients (76%) thought a bonus paid for ordering fewer than the average number of tests would adversely affect the quality of their care. About half of the patients (53%) thought a particular type of withhold would adversely affect the quality of their care. White patients, college graduates, and those who had higher incomes were more likely to think that these types of bonuses and withholds would have a negative impact on their care. Among patients who believed that these types of bonuses adversely affected care, those with non-managed fee-for-service insurance and college graduates were more willing to pay a higher deductible or co-payment in order to get tests that they thought were necessary. CONCLUSIONS: Most patients were unaware of how their physicians are paid, and only about half wanted to know. Most believed that bonuses or withholds designed to reduce the use of services would adversely affect the quality of their care. Lack of knowledge combined with strong attitudes about various financial incentives suggest that improved patient education could clarify patient understanding of the nature and rationale for different types of incentives. More public discussion of this important topic is warranted.

Validating recommendations for coronary angiography following acute myocardial infarction in the elderly: a matched analysis using propensity scores.

We determined whether adherence to recommendations for coronary angiography more than 12 h after symptom onset but prior to hospital discharge after acute myocardial infarction (AMI) resulted in better survival. Using propensity scores, we created a matched retrospective sample of 19,568 Medicare patients hospitalized with AMI during 1994-1995 in the United States. Twenty-nine percent, 36%, and 34% of patients were judged necessary, appropriate, or uncertain, respectively, for angiography while 60% of those judged necessary received the procedure during the hospitalization. The 3-year survival benefit was largest for patients rated necessary [mean survival difference (95% CI): 17.6% (15.1, 20.1)] and smallest for those rated uncertain [8.8% (6.8, 10.7)]. Angiography recommendations appear to select patients who are likely to benefit from the procedure and the consequent interventions. Because of the magnitude of the benefit and of the number of patients involved, steps should be taken to replicate these findings.

Use of consumer ratings for quality improvement in behavioral health insurance plans.

BACKGROUND: The Consumer Assessment of Behavioral Healthcare Services (CABHS) survey collects consumers' reports about their health care plans and treatment. The use of the CABHS to identify opportunities for improvement, with specific attention to how organizations have used the survey information for quality improvement, is described. METHODS: In 1998 and 1999, data were collected from five groups of adult patients in commercial health plans and five groups of adult patients in public assistance health plans with services received through four organizations (one of three managed behavioral health care organizations or a health system). Patients who received behavioral health care services during the previous year were mailed the CABHS survey. Non-respondents were contacted by telephone to complete the survey. RESULTS: Response rates ranged from 49% to 65% for commercial patient groups and from 36% to 51% for public assistance patients. Promptly getting treatment from clinicians and aspects of care most influenced by health plan policies and operations, such as access to treatment and plan administrative services, received the least positive responses, whereas questions about communication received the most positive responses. In addition, questions about access- and plan-related aspects of quality showed the most interplan variability. Three of the organizations in this study focused quality improvement efforts on access to treatment. DISCUSSION: Surveys such as the CABHS can identify aspects of the plan and treatment that are improvement priorities. Use of these data is likely to extend beyond the behavioral health plan to consumers, purchasers, regulators, and policymakers, particularly because the National Committee for Quality Assurance is encouraging behavioral health plans to use a similar survey for accreditation purposes.

Health plan characteristics and consumers' assessments of quality.

Many purchasers and consumers of health care have become concerned about the quality of care being delivered in managed care plans. Little is known, however, about the health plan characteristics that are associated with better performance. We used survey responses from 82,583 Medicare beneficiaries from 182 health plans to study the association of consumers' assessments of care with health plan characteristics. For-profit and nationally affiliated health plans received much worse scores on the outcomes of interest, particularly for overall ratings of the health plan and composite measures of customer service and access to care. Health plans accredited by the National Committee for Quality Assurance did not receive higher scores.

Quality of informed consent: a new measure of understanding among research subjects.

BACKGROUND: The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking. METHODS AND RESULTS: We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and perceived (subjective) understanding of cancer clinical trials. The QuIC incorporates the basic elements of informed consent specified in federal regulations, assesses the therapeutic misconception (the belief that all aspects of a clinical trial are designed to directly benefit the subject), and employs the language and structure of the new National Cancer Institute template for informed consent documents. We modified the QuIC after receiving feedback from pilot tests with cancer research subjects, as well as validation from two independent expert panels. We then sent the QuIC to 287 adult cancer patients enrolled on phase I, II, or III clinical trials. Two hundred seven subjects (72%) completed the QuIC. To assess test-retest reliability, a random sample of 32 respondents was selected, of whom 17 (53%) completed the questionnaire a second time. The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective understanding and.77 for tests of subjective understanding. The current version of the QuIC, which consists of 20 questions for objective understanding and 14 questions for subjective understanding, was tested for time and ease of administration in a sample of nine adult cancer patients. The QuIC required an average of 7.2 minutes to complete. CONCLUSIONS: The QuIC is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.