The significance of treatment effects: the clinical perspective.
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Health Status Indicators↗
Biomedical subjects
D L Patrick
Publications and source records attributed to D L Patrick.
Medicare reimbursement for preventive care. Changes in performance of services, quality of life, and health care costs.
A randomized, controlled trial was conducted to assess the effects of a financial and office systems intervention to increase preventive care in physicians' offices for patients aged 65 years or older. A total of 1,914 patients from 10 primary-care medical practices in central North Carolina were randomized within practices to an intervention and a usual-care control group. The intervention consisted of full Medicare reimbursement to physicians for preventive care and health promotion packages (thus making these services free for patients), regular prompting of physicians to routinely schedule preventive care visits, a new office system in which nurses carried out many preventive procedures, and a form for charting preventive care. The performance of screening tests dramatically increased in the intervention group relative to control (P < 0.001), but there was evidence of lack of follow-up of abnormal findings by physicians. At the 2-year follow-up, there were minimal differences between intervention and control groups in health-related quality-of-life indicators. Relative to the $294 per patient 3-year cost to Medicare for waivered services, the intervention was reimbursed-cost neutral or slightly cost reducing ($190 over 3 years) for Medicare. It is concluded that adding reimbursement for preventive services to Medicare--even with the office systems changes made in this study--will not by itself lead to effective implementation of preventive services in community medical practices. To enhance patient benefit from preventive services, greater attention needs to be focused on an organized approach to patient follow-up.
Aged↗
Stability of choices about life-sustaining treatments.
OBJECTIVE: To examine the stability of patients' choices for life-sustaining treatments. DESIGN: A longitudinal cohort study. SETTING: Primary care practices in central North Carolina. PATIENTS: Medicare recipients (n = 2536). INTERVENTION: Participants were asked about demographic characteristics, health status, well-being, depression, social support, use of a living will, and desire for life-sustaining treatment if they were to become terminally ill. These questions were repeated 2 years later (n = 2073, 82% follow-up). RESULTS: The population tended to choose to forego one more treatment at follow-up than they did at baseline. A choice to forego treatment was twice as stable as a choice to receive treatment. Patients with a living will were less likely to change their wishes (14%) than those without a living will (41%). Persons were more likely to want increased treatment at a later time if they had been hospitalized (23% compared with 18%), had had an accident (29% compared with 19%), had become more immobile (23% compared with 19%), had become more depressed (25% compared with 15%), or had less social support (25% compared with 14%). CONCLUSIONS: Most patients (85%) who had chosen to forego life-sustaining treatments did not change their choices. Nonetheless, these data suggest that it is important to review patients' preferences for life-sustaining treatments rather than to assume the stability of their choices.
Advance Directive Adherence↗
Untreated anxiety among adult primary care patients in a Health Maintenance Organization.
BACKGROUND: Untreated anxiety may be particularly difficult for primary care physicians to recognize and diagnose because there are no reliable demographic or medical profiles for patients with this condition and because these patients present with a high rate of comorbid psychological conditions that complicate selection of treatment. METHOD: A prospective assessment of untreated anxiety symptoms and disorders among primary care patients. RESULTS: Approximately 10% of eligible patients screened in clinic waiting rooms of a mixed-model health maintenance organization reported elevated symptoms and/or disorders of anxiety that were unrecognized and untreated. These patients with untreated anxiety reported significantly worse functioning on both physical and emotional measures than "not anxious" comparison patients; in fact these patients reported reduced functioning levels within ranges that would be expected for patients with chronic physical diseases, such as diabetes and congestive heart failure. The most severe reductions in functioning were reported by untreated patients whose anxiety was mixed with depression symptoms or disorders. CONCLUSION: Primary care physicians may benefit from screening tools and consultations by mental health specialists to assist in recognition and diagnosis of anxiety symptoms and disorders alone and mixed with depression.
Adaptation, Psychological↗
Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach.
There is a growing demand for tools to assess outcomes multinationally for use in international clinical trials. This has been accompanied by the need to produce valid and reliable questionnaires in a multiplicity of languages within a short time frame. We present an eight-step protocol for rapidly translating a quality of life (QOL) questionnaire into multiple languages, and demonstrate the protocol's utility and effectiveness by evaluating the translations for reliability and validity. The rapid translation protocol represents a minimalist approach to QOL questionnaire translation. Although this minimalist approach is not considered a recommended methodology, it may represent a feasible mechanism for questionnaire translation under certain circumstances. Most of the steps were completed in the USA, including a translation and back-translation by bilingual translators who were native speakers in the target-language, a test-retest of the translated instrument on five bilingual respondents to establish language and cultural equivalence and review of the translation by and editorial review board. The translated instrument was performance tested in the target language country on a pilot population of patients to determine its reliability and validity. Based on the findings, the instrument was further refined for use in the clinical trial.
Adult↗
Necessary but not sufficient: the effect of screening and feedback on outcomes of primary care patients with untreated anxiety.
OBJECTIVE: To consider the impact on primary care patient outcomes of using both a screener to determine elevated anxiety levels among patients with previously undetected anxiety and a physician intervention to inform physicians of their patients' conditions. DESIGN: Participating physicians were randomized to either the demonstration or the control arm, and patients were assigned to a study arm based on the randomization of their physicians. The patients were followed for change in outcome measures during the five-month study period. SETTING: A mixed-model health maintenance organization serving approximately 110,000 enrollees in central Colorado. PATIENTS/PARTICIPANTS: 573 patients who had unrecognized and untreated anxiety identified from the approximately 8,000 patients who completed the waiting room screening questionnaire. INTERVENTIONS: A physician intervention served the dual function of 1) providing an educational demonstration of anxiety in the primary care setting and 2) providing a reporting system for summarizing the anxiety symptom levels and functioning status of the patients enrolled in the study. MEASUREMENTS AND MAIN RESULTS: Patient outcomes were measured as changes in global anxiety scores, functioning and well-being, and patients' reports of global improvements. CONCLUSIONS: The findings indicate that this method of reporting symptoms and functioning status to primary care physicians did not significantly change patient outcomes. Improvement in outcomes appeared to be more closely associated with the patient's severity of psychological distress.
Adult↗
Measuring, managing, and improving quality in the end-stage renal disease treatment setting: committee statement.
The Institute of Medicine (IOM) committee that organized the conference reported in this issue of the journal on assessing quality of care and quality of life, wishes to emphasize that it regards the task of measuring quality as one that can be approached systematically, albeit with caution. Outcomes of end-stage renal disease (ESRD) care by dialysis and transplantation (and variations of outcomes among treatment units) and related processes of care need to be measured in ways useful to clinicians. In addition to clinical measures of outcome, the committee also favored giving greater attention to functional outcomes and health-related quality of life. The interest in maintaining and improving quality in the treatment setting reflects an underlying need to encourage its systematic assessment on a sustained basis, with appropriate weight devoted to practical issues.
Humans↗
Toward an epidemiology of disablement.
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Data Collection↗
The validity of self-reported smoking: a review and meta-analysis.
OBJECTIVES: The purpose of this study was to identify circumstances in which biochemical assessments of smoking produce systematically higher or lower estimates of smoking than self-reports. A secondary aim was to evaluate different statistical approaches to analyzing variation in validity estimates. METHODS: Literature searches and personal inquiries identified 26 published reports containing 51 comparisons between self-reported behavior and biochemical measures. The sensitivity and specificity of self-reports of smoking were calculated for each study as measures of accuracy. RESULTS: Sensitivity ranged from 6% to 100% (mean = 87.5%), and specificity ranged from 33% to 100% (mean = 89.2%). Interviewer-administered questionnaires, observational studies, reports by adults, and biochemical validation with cotinine plasma were associated with higher estimates of sensitivity and specificity. CONCLUSIONS: Self-reports of smoking are accurate in most studies. To improve accuracy, biochemical assessment, preferably with cotinine plasma, should be considered in intervention studies and student populations.
Humans↗
Methodological issues in measuring patient-reported outcomes: the agenda of the Work Group on Outcomes Assessment.
The primary goal of the Inter-PORT work group on Outcomes Assessment is to foster methodological knowledge about the implications of various measure and design decisions for studies of the outcomes of treatment. A number of key methodological issues currently are unresolved and are in need of further study. These include: 1) the best questions to ask to assess how patients are affected by their treatments; 2) the comparative advantages of various study designs, including prospective cohorts, retrospective studies, and randomized clinical trials; 3) the way data collection decisions, such as mode of data collection and use of proxy respondents, affect study results; and 4) the best way to assess the significance of observed effects from patient, provider, and public policy perspectives. Studies conducted by the Patients Outcomes Research Teams (PORTs) are using diverse designs, measures, and data collection procedures. They provide a unique opportunity to further knowledge about methods of obtaining information about treatment outcomes. Through meetings, conferences, and publications, the Inter-PORT work group on Outcomes Assessment is trying to stimulate analyses aimed at methodological issues summarized in this paper and to ensure that new knowledge about methods is disseminated to a wide audience.
Cohort Studies↗
Measuring health-related quality of life.
Clinicians and policymakers are recognizing the importance of measuring health-related quality of life (HRQL) to inform patient management and policy decisions. Self- or interviewer-administered questionnaires can be used to measure cross-sectional differences in quality of life between patients at a point in time (discriminative instruments) or longitudinal changes in HRQL within patients during a period of time (evaluative instruments). Both discriminative and evaluative instruments must be valid (really measuring what they are supposed to measure) and have a high ratio of signal to noise (reliability and responsiveness, respectively). Reliable discriminative instruments are able to reproducibly differentiate between persons. Responsive evaluative measures are able to detect important changes in HRQL during a period of time, even if those changes are small. Health-related quality of life measures should also be interpretable--that is, clinicians and policymakers must be able to identify differences in scores that correspond to trivial, small, moderate, and large differences. Two basic approaches to quality-of-life measurement are available: generic instruments that provide a summary of HRQL; and specific instruments that focus on problems associated with single disease states, patient groups, or areas of function. Generic instruments include health profiles and instruments that generate health utilities. The approaches are not mutually exclusive. Each approach has its strengths and weaknesses and may be suitable for different circumstances. Investigations in HRQL have led to instruments suitable for detecting minimally important effects in clinical trials, for measuring the health of populations, and for providing information for policy decisions.
Chronic Disease↗
Quality of life of persons with onychomycosis.
Onychomycosis is a fungal infection of the nails which, although unsightly in appearance, is often considered to be a cosmetic problem. This research reports on the development and performance of a quality-of-life instrument to measure the impact of this disease on the patients' mental and general health, social functioning, pain, and self-confidence. In telephone interviews, 680 members of a health maintenance organization (299 with onychomycosis and 381 without) were asked a battery of items regarding quality of life (mental and social functioning, self-esteem, pain) and specific problems and symptoms related with one's nails. Persons with onychomycosis had significantly poorer ratings compared with the healthy persons with respect to general health (p = 0.02) and bodily pain p < 0.001). Persons with onychomycosis also had significantly (p < 0.05) poorer ratings for mental health, social functioning, health concern, physical appearance, and functional limitations associated with activities involving standing on one's feet or working with one's fingers. This study is the first to document the impact of onychomycosis on an individual's quality of life. Persons with onychomycosis may adapt to this condition, but they continue to experience embarrassment and discomfort that reduces their quality of life.
Adolescent↗
Life-sustaining treatments during terminal illness: who wants what?
OBJECTIVE: To determine patient characteristics associated with the desire for life-sustaining treatments in the event of terminal illness. DESIGN: In-person survey from October 1986 to June 1988. SETTING: 13 internal medicine and family practices in North Carolina. PATIENTS: 2,536 patients (46% of those eligible) aged 65 years and older who were continuing care patients of participating practices, enrolled in Medicare. The patients were slightly older than the 65+ general population, 61% female, and 69% white, and most had one or more chronic illnesses. MEASUREMENTS AND MAIN RESULTS: The authors asked the patients whether they would want each of six different treatments (hospitalization, intensive care, cardiopulmonary resuscitation, surgery, artificial ventilation, or tube feeding) if they were to have a terminal illness. The authors combined responses into three categories ranging from the desire for more treatment to the desire for less treatment. After adjustment for other factors, 53% of women chose less treatment compared with 43% of men; 35% of blacks vs 15% of whites and 23% of the less well educated vs 15% of the better educated expressed the desire for more treatment. High depression scores also were associated with the desire for more treatment (26% for depressed vs 18% for others). CONCLUSION: Patients' choices for care in the event of terminal illness relate to an intricate set of demographic, educational, and cultural factors. These results should not be used as a shortcut to determine patient preferences for care, but may provide new insights into the basis for patients' preferences. In discussing choices for future life-sustaining care, physicians need to explore with each individual the basis for his or her choices.
Aged↗
Disease-specific versus generic measurement of health-related quality of life in insulin-dependent diabetic patients.
The health-related quality of life of 170 adult insulin-dependent diabetic patients was measured cross-sectionally to compare a disease-specific instrument, Diabetes Quality of Life (DQOL) questionnaire, and two generic instruments, the Duke Health Profile (DUKE) and the General Health Perceptions Questionnaire (GHP). The generic measures provided as much or more information about health-related quality of life as the disease-specific instrument. This was demonstrated both by comparison of the DQOL with the DUKE and GHP and by comparison of the disease-specific with the generic components of a modified version of the DQOL. Patients with the diabetic complication of nephropathy had increased worry over their health and lower general health perceptions. Neither the duration of diabetes nor the intensity of insulin therapy, however, was found to have a statistically significant effect on any of the health-related quality of life scores. Nondiabetic factors, such as the comorbidity, nondiabetic medications, marital status, social relationships, and family arguments were found to be predictors of health-related quality of life more often than the diabetic factors duration of diabetes, complications, and intensity of insulin therapy. These analyses suggest the clinical value of using generic questionnaires to measure health-related quality of life and psychosocial factors to identify nondiabetic problems that might respond to intervention, thereby potentially enhancing the effect of diabetes-specific therapy.
Adolescent↗
Who enrolled in a state program for the uninsured: was there adverse selection?
Managed care plans may hesitate to participate in programs for uninsured persons because they fear adverse selection, whereby only the sickest people or highest users would choose to join the program. We studied this issue in Washington State's Basic Health Plan, a demonstration program that provides subsidized health insurance for families earning less than 200% of the poverty level. We interviewed people in three counties who enrolled in the program, and compared them to people in the same counties who were eligible but did not enroll. There were substantial differences between enrollees and eligibles in education, age, income, employment, race, and insurance status. In spite of these demographic and access differences, health status was remarkably similar for enrollees and eligibles, with the few significant differences favoring the enrollees. In addition, previous and subsequent use of health services was similar or lower for enrollees. The results for health status and utilization were similar across the three counties, even though the counties and the providers were quite different. We conclude that there is no evidence of adverse selection. This is welcome news for the health plans, but suggests that the BHP may not have reached those most in need of insurance.
Age Factors↗
Race and survival time with AIDS: a synthesis of the literature.
OBJECTIVE: This study summarizes the evidence concerning the association of Black and White race with acquired immunodeficiency syndrome (AIDS) survival time. METHODS: English-language articles measuring survival time with AIDS for Black and White persons were reviewed. Each article was assigned to one of three groups based on the method of subject accrual. RESULTS: Of the nine eligible studies identified, five studies had inclusive methods of accruing study subjects, and four of these five showed decreased survival time among Black persons. In the studies with more restrictive accrual methods, survival time for Blacks was not decreased. CONCLUSIONS: Although the published studies vary in their results, this variation appears to be systematic according to the method of accruing study subjects. If the accrual method serves to minimize socioeconomic differences between Blacks and Whites, there is no difference in survival time by race. However, if a more inclusive method is used, a significant decrease in AIDS survival time is observed among Blacks. This analysis suggests that, in some studies, race may function as a marker for socioeconomic factors and/or access to health care and that AIDS patients in the lowest socioeconomic or access group have significantly shorter survival times.
Acquired Immunodeficiency Syndrome↗
Insights pertaining to patient assessments of states worse than death.
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Adult↗
Validation of a symptoms questionnaire for benign prostatic hyperplasia.
We developed a questionnaire to assess the effect of finasteride on symptoms of benign prostatic hyperplasia (BPH) by modifying that of Boyarsky (1977). To validate the questionnaire, a cohort study was conducted in 2 groups of patients with BPH and 3 control groups without BPH. The BPH groups were: (1) 34 patients before TURP (transurethral resection of the prostate), average age 68 years; (2) 65 patients after TURP, average age 68 years; (3) 40 patients after other nonserious nonurological surgery, average age 50 years; (4) 14 healthy non-BPH volunteers, average age 58 years; and (5) 73 healthy non-BPH volunteers, average age 37 years. The questionnaire was administered once to all subjects, and a subset responded to a second administration. Mean total symptoms scores (TSS) from the initial questioning were 6.4, 3.2, 2.9, 2.6, and 1.6 for the 5 groups, respectively (pooled SD = 3.3); mean total troublesome symptoms scores (TTSS) were 4.8, 2.1, 1.4, 1.1, and 0.6, respectively (pooled SD = 2.2). All other groups were significantly less symptomatic and troubled than the pre-TURP group, and all surgical groups were significantly more so than the younger volunteer group. These data demonstrate the discriminant validity of the questionnaire. Corroborating prior data [Gregg et al., 1990], responsiveness was shown by the 3.7-point mean TSS improvement in response to TURP, which was significantly different from the near-zero changes in the other groups. Reproducibility was shown by kappa statistics being nearly all greater than 0.75 and an intraclass correlation coefficient of 0.64; construct validity and reliability were demonstrated by correlation (r = 0.7) with a general urination problems question; and internal consistency was documented by Cronbach's alpha values of approximately 0.6. We conclude that this questionnaire is a useful and validated tool for assessing BPH symptoms.
Evaluation Studies as Topic↗