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Biomedical subjects

D L Patrick

Publications and source records attributed to D L Patrick.

At least 19 recordsLinked to original sources

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

Ulcerative colitis and Crohn's disease health status scales for research and clinical practice.

We report the development of ulcerative colitis (UC) and Crohn's disease (CD) Health Status Scales that improve on existing inflammatory bowel disease (IBD) activity measures by their added association with health status. We surveyed 991 members of the Crohn's and Colitis Foundation of America (CCFA) and analyzed the half with greater disease activity (114 UC, 330 CD, ostomies excluded). Our analysis strategy involved (a) identification of items that discriminated active from inactive disease, (b) factor analysis to reduce the items to clusters sharing common symptom relationships, and (c) regression analysis to select those variables best associated with a composite measure of health status (health care use, daily function, psychologic distress). The factor analyses yielded two indexes for UC and CD: "Diarrhea," and "Other GI symptoms" (Cronbach's alpha 0.59-0.84). The regression analyses for both diseases showed that poorer well-being, the Diarrhea index, and dependence on medication for pain were associated with poorer health status. For UC, lower educational attainment and lower steroid dose, and for CD, the Other GI symptoms index and eye disease, also correlated with poorer health status. By design, the UC and CD Scales are better predictors of health status than the survey version of the CD Activity Index (CDAI), explaining 17 and 21% more of the variance of the health status measure. The final UC and CD Health Status Scales can be used in research and clinical care. They contain symptom items used to assess disease activity and also correlate with health status. Prospective assessment is needed to confirm their accuracy in assessing prognosis and treatment response.

Adult

Restricted activity days among older adults.

OBJECTIVES: The number of restricted activity days experienced by an individual in the course of a year is an important measure of functional well-being, particularly for older adults. We sought to determine multivariate associations between restricted activity days and various health conditions. METHODS: We used data from the 1984 Supplement on Aging of the National Health Interview Survey to estimate the relationship between restricted activity days and age, gender, and the presence or absence of selected chronic conditions and falls for all noninstitutionalized people aged 65 years and over. Chronic conditions and falls accounted for most of the variance in the model. RESULTS: Of an annual average of 31 restricted activity days, 6 days were associated with falls; 4 days with heart disease; 4 days with arthritis and rheumatism; 2 days each with high blood pressure, cerebrovascular disease, and visual impairment; and 1 day each with atherosclerosis, diabetes, major malignancies, and osteoporosis. CONCLUSIONS: These results can be used in estimating the potential impact of health promotion programs on the health status of noninstitutionalized older adults.

Accidental Falls

A prospective study of advance directives for life-sustaining care.

BACKGROUND: The use of advance directives is recommended so that people can determine the medical care they will receive when they are no longer competent, but the effectiveness of such directives is not clear. METHODS: In a prospective study conducted over a two-year period, 126 competent residents of a nursing home and 49 family members of incompetent patients were interviewed to determine their preferences with respect to hospitalization, intensive care, cardiopulmonary resuscitation, artificial ventilation, surgery, and tube feeding in the event of critical illness, terminal illness, or permanent unconsciousness. Advance directives, consisting of signed statements of treatment preferences, were placed in the medical record to assist in care in the nursing home and to be forwarded to the hospital if necessary. RESULTS: In an analysis of 96 outcome events (hospitalization or death in the nursing home), care was consistent with previously expressed wishes 75 percent of the time; however, the presence of the written advance directive in the medical record did not facilitate consistency. Among the 24 events in which inconsistencies occurred, care was provided more aggressively than had been requested in 6 cases, largely because of unanticipated surgery or artificial ventilation, and less aggressively than requested in 18, largely because hospitalization or cardiopulmonary resuscitation was withheld. Inconsistencies were more likely in the nursing home than in the hospital. CONCLUSIONS. The effectiveness of written advance directives is limited by inattention to them and by decisions to place priority on considerations other than the patient's autonomy. Since our study was performed in only one nursing home and one hospital, other studies are necessary to determine the generalizability of our findings.

Adult

Health status and health care use in persons with inflammatory bowel disease. A national sample.

We randomly surveyed 997 members of the Crohn's and Colitis Foundation of America with inflammatory bowel disease (320 ulcerative colitis and 671 Crohn's disease) in order to: (1) assess their health status, (2) compare members with ulcerative colitis and Crohn's disease, and (3) determine the correlates of health care use. Data collection included variables relating to physical and psychological symptoms, medication use, daily functional status, perceptions of health, and coping styles. The findings indicate that: (1) despite a number of symptoms and complications related to inflammatory bowel disease, the health status of this population is generally good and may be a result of effective coping styles; (2) those with Crohn's disease have more psychosocial difficulties, which appear related to greater symptom severity; (3) both psychosocial and physical health variables are related to number of physician visits, while primarily physical health variables are related to number of hospitalizations and surgeries. Further studies are needed to determine the representativeness of this self-selected sample with others having IBD. In this study, we have provided the basis for developing a more sensitive measure of health status than currently exists, and one which may have implications for future clinical studies.

Adaptation, Psychological

Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation.

Before being introduced to wide use, health status instruments should be evaluated for reliability and validity. Increasingly, they are also tested for responsiveness to important clinical changes. Although standards exist for assessing these properties, confusion and inconsistency arise because multiple statistics are used for the same property; controversy exists over how to measure responsiveness; many statistics are unavailable on common software programs; strategies for measuring these properties vary; and it is often unclear how to define a clinically important change in patient status. Using data from a clinical trial of therapy for back pain, we demonstrate the calculation of several statistics for measuring reproducibility and responsiveness, and demonstrate relationships among them. Simple computational guides for several statistics are provided. We conclude that reproducibility should generally be quantified with the intraclass correlation coefficient rather than the more common Pearson r. Assessing reproducibility by retest at one-to-two week intervals (rather than a shorter interval) may result in more realistic estimates of the variability to be observed among control subjects in a longitudinal study. Instrument responsiveness should be quantified using indicators of effect size, a modified effect size statistic proposed by Guyatt, or the use of receiver operating characteristic (ROC) curves to describe how well various score changes can distinguish improved from unimproved patients.

Analysis of Variance

Participation and adherence among older men and women recruited to the Beta-Carotene and Retinol Efficacy trial (CARET).

We evaluated as functions of age and gender participation and adherence rates in older adults recruited to pilot studies for CARET, a multicenter chemoprevention trial. Eligible were men and women aged 50-69 who were current or recent former smokers, and men aged 45-74 with occupational exposure to asbestos. We found negligible differences by age in response to recruitment mailings, drop out during the enrollment process and after randomization, and adherence to taking the study capsules. Men had numerically lower drop-out and higher adherence rates than women, but differences were not statistically significant. These results should encourage researchers to recruit older men and women (at least up to age 69) to clinical trials.

Age Factors

Participation of higher users in a randomized trial of Medicare reimbursement for preventive services.

In a study of older enrollees in an HMO, we found that seniors who are higher users of health care services are willing to participate in health promotion programs. Although people aged 85 or older and those with chronic diseases are slightly more reluctant to participate, they are willing to make additional visits for health promotion purposes. Close proximity to the clinic and support from their family physician are important correlates of participation.

Age Factors

Measurement of health status in the 1990s.

The use of health-related quality of life measures, especially those based on function, are likely to increase during the next decade. This increase, however, is most likely to occur in clinical research and clinical practice. Unless the necessary political will, resources, data, and policy researchers coexist, there will be relatively little advance in the use of health status measures for decision-making and policy. This prediction is based on the observation that policy research tends to rely on available national data, that currently these data provide limited information about health status, and that there appears to be insufficient interest and resources to broaden data collection or to develop methods that incorporate a broad spectrum of health outcomes (e.g. death, impairment, functional status, and perceptions) into a single instrument or measure of health on large populations and communities. This state of affairs is particularly unfortunate as we face a decade in which available health and medical care may become more limited and social inequity in access and health status may become more marked. The effect of social inequities and restrictions to health care on the health of the nation cannot continue to be determined with reference only to the structure and process of the health care system. Health and quality of life outcomes are what count. And, these outcomes cannot be determined without appropriate and inclusive measures of health-related quality of life. Of course, we hope our prediction is wrong and that the motivation and resources will be found to help resolve methodologic issues in the measurement of population health status and quality of life and to provide the necessary data. We hope that government agencies, employers, and private providers will begin to collect health-related quality of life data on the constituents and populations they serve. Even if these data are imperfect or primitive, the effects of improving accessibility and quality of health care can only be assessed adequately in terms of the health-related quality of life of the nation.

Community Health Services

Measuring quality of life in clinical trials: a taxonomy and review.

Measurement of quality of life is becoming increasingly relevant to controlled clinical trials. Two basic types of instrument are available: generic instruments, which include health profiles and utility measurements based on the patient's preferences in regard to treatment and outcome; and specific instruments, which focus on problems associated with individual diseases, patient groups or areas of function. The two approaches are not mutually exclusive; each has its strengths and weaknesses and may be suitable under different circumstances. We surveyed 75 randomized trials published in three medical journals in 1986 and categorized them according to the importance of quality of life as a measure of outcome and the extent to which quality of life was actually measured. Although a number of the investigators used quality-of-life instruments in a sophisticated manner, in only 10 of 55 trials in which the measurement had been judged to be crucial or important were instruments with established validity and responsiveness used. We conclude that although accurate measurement of quality of life in randomized trials is now feasible it is still not widely done. Using the framework we have outlined, investigators can choose generic or specific instruments according to the purpose and the focus of their trial.

Clinical Trials as Topic

Health-related quality of life in inflammatory bowel disease. Functional status and patient worries and concerns.

The assessment of health-related quality of life may be an adjunct to understanding the chronic illness experience and its effects on health outcomes. In this study, we evaluated health-related quality of life of 150 patients with inflammatory bowel disease (63 ulcerative colitis, 87 Crohn's disease). We used a standardized measure, the Sickness Impact Profile, and a questionnaire we developed that elicits and prioritizes the disease-related worries and concerns of patients with IBD. Our preliminary data indicate that: (1) IBD patients experience moderate functional impairment more in the social and psychological than in the physical dimensions; (2) Crohn's disease patients report psychosocial dysfunction to a greater degree than ulcerative colitis patients; (3) IBD patients report greatest concerns about having surgery, degree of energy, and body image issues such as having an ostomy bag; and (4) functional status and patient concerns correlate better with other measures of health status and previous health care utilization than the physician's rating of disease activity. We believe that questionnaires measuring health-related quality of life (HRQOL) can be used in research and patient care to extend the clinical assessment of patients with IBD. Further work is needed to determine the role of HRQOL relative to disease activity and other physician-based assessments in predicting health outcomes.

Adult

Generic and disease-specific measures in assessing health status and quality of life.

Application of generic and specific measures of health status and quality of life to different diseases, conditions, states, and populations is increasing. Four strategies for using these measures are separate generic and specific measures, modified generic measures, disease-specific supplements, and batteries. The preferred strategy depends on project aims, methodological concerns, and practical constraints. Generic measures are necessary to compare outcomes across different populations and interventions, particularly for cost-effectiveness studies. Disease-specific measures assess the special states and concerns of diagnostic groups. Specific measures may be more sensitive for the detection and quantification of small changes that are important to clinicians or patients. Comparison studies are needed of the validity, reliability, and responsiveness of generic and disease-specific measures in the same population and in minority and age-specific groups.

Chronic Disease

Barriers to the use of health status measures in clinical investigation, patient care, and policy research.

Despite growing interest and sophistication in health status assessment, these measures are not widely used in settings where they would be appropriate. The reasons include conceptual, methodologic, practical, and attitudinal barriers, some of which are common to a variety of applications (e.g., clinical research, patient care, or policy research). These barriers include skepticism about the validity and importance of self-rated health; preferences for physiologic outcomes or death rates; unfamiliarity with questionnaire scores; a paucity of direct instrument comparisons to aid in selection; and the costs of pilot testing, data collection, and data manipulation. In clinical trials, the uncertain responsiveness of questionnaire instruments to small but clinically important changes may be of particular concern. For patient care, additional barriers are posed by the need for rapidly processing data, the need for providing highly understandable results to clinicians, and clinicians' uncertainty about how to use the information. In policy research, there is often insufficient time for responding (with health status measurement) to decision makers' needs, and many have reservations about concepts such as quality-adjusted life years that arise from health status measurement. To facilitate a better intuitive grasp of health status scores, more comparisons with traditional clinical scales and physiologic measures are needed. More effort should be given to demonstrating (and improving) the responsiveness of scales to clinically important changes and to developing very brief questionnaires. Better education of health professionals about these measurement techniques is needed, as well as better methods of presenting results. Finally, a "laboratory" to provide measurement services to investigators and clinicians may make use of these scales more attractive.

Attitude of Health Personnel

Collaboration, consultation and referral in an integrated health-mental health program at an HMO.

The paper describes interactions between primary care physicians (PCP's) and mental health clinicians (MHC's) in a "team collaborative model." A study of the interactions showed there were about two consultations a day with PCP's for each MHC, that they were largely unscheduled, took place mostly in PCP or MHC offices or in corridors, and increased in frequency over a two-year period. Role definition was a continuing process; PCP's and MHC's each learned through repeated discussions what to expect from the other in patient care. It is found that a model with close working arrangements between PCP's and MHC's is of therapeutic value for that large population of emotionally disturbed patients seen often by PCP's much less often by MHC's.

Community Mental Health Services

Primary care treatment of emotional problems in an HMO.

Integrating mental health services into primary care should improve the availability, access, and delivery of psychiatric care to the whole population. Health maintenance organizations (HMOs) are settings for the development of integrated medical-mental health services. This paper reports findings of a project to evaluate a team collaborative model in an HMO. In this model, primary care clinicians carry major responsibility for emotional problems of their patients, and mental health clinicians collaborate with and support primary care clinicians as well as treat referred patients. Over a two-year study period, 15.7 per cent of all patients who visited the HMO presented a mental or emotional difficulty. When psychotropic drug prescriptions were used as an unobtrusive measure for estimating underenumeration, this prevalence figure rose to 19 per cent. Primary care clinicians treated an increasing proportion of the emotional problem demand, although this increase could not be attributed only to the establishment of the team collaborative model. Findings concerning the psychiatric problems treated and psychotropic drugs prescribed by primary care clinicians are also presented. We conclude that the primary care clinicians did assume major responsibility for emotional problem treatment when encouraged and supported through the team collaborative process and other organizational arrangements.

Affective Symptoms