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Biomedical subjects

D E Kanouse

Publications and source records attributed to D E Kanouse.

At least 37 records · Page 2Linked to original sources
PubMed1996

The impact of zidovudine compared with didanosine on health status and functioning in persons with advanced HIV infection and a varying duration of prior zidovudine therapy. AIDS Clinical Trials Group 116/117 Study Group.

The objective of this study was to compare the effects of zidovudine and didanosine on health-related quality of life in persons with advanced HIV infection and varying duration of prior zidovudine exposure. It was designed as a substudy nested in two similar placebo-controlled active-control-arm randomized trials, using sites of the AIDS Clinical Trials Group participating in the randomized trials of zidovudine versus didanosine (ACTG 116 and 117). The patients comprised 356 participants enrolled in ACTG 116 and 117. All had HIV infection and either a CD4 count of <200 cells/mm3, or a CD4 count of <300 cells/mm3 plus symptoms of HIV disease. Participants were randomized equally within strata defined by duration of prior zidovudine therapy, to receive didanosine sachets at a dose of 500 mg daily (334 mg in subjects weighing <60 kg) or 750 mg daily (500 mg in subjects weighting <60 kg) plus inactive capsules resembling zidovudine, or to receive zidovudine capsules at a dose of 600 mg daily plus inactive sachets resembling didanosine. The main outcome measures were self-reported health-related quality of life, healthcare utilization, disability, work and symptom impact. The results showed no differences in reported symptom impact or healthcare utilization, and most measures of disability were similar. In the group with more than 8 weeks of prior zidovudine therapy, several of the health status scale scores for ongoing participants were significantly better for didanosine recipients, but average differences were small. Use of several different approaches to combining health status and survival showed no differences in the overall quality-time experiences between the treatment groups. Individuals taking zidovudine, low-dose didanosine and high-dose didanosine experienced 33, 34 and 35 weeks, respectively, in at least the typical health state if they had fewer than 8 weeks of previous zidovudine therapy, and had 23, 23 and 26 weeks, respectively, if they had more than 8 weeks previous use of zidovudine. Results did not differ when data were analysed within strata ofpatients who had any versus no prior exposure to zidovudine, or AIDS versus non-AIDS status. In conclusion, functional status and health-related quality of life were substantially similar among persons receiving either zidovudine or didanosine, regardless of the duration of prior zidovudine treatment.

Adult↗
PubMed1995

Derivation and properties of a brief health status assessment instrument for use in HIV disease.

Health status measures adapted from the Medical Outcomes Study (MOS) scales have been shown to be useful and highly reliable in human immunodeficiency virus-infected populations, but acceptance of these measures has been limited in part by concerns over investigator, patient, and data burden. We sought to address these concerns by reducing the number of items in the MOS scales rather than by reducing the number of domains covered. We selected items for the shorter scales based on the static and dynamic relationships to the longer scales and to indicators of clinical and functional status in 10,399 responses from 1,934 participants, as well as in relevant subpopulations. The resulting scales have a total of 21 items, as compared to 38 in the longer instrument. Correlations between the shorter and longer scales were excellent. At 0.78 to 0.85, the reliability of the subscales was lower than that of the full scales. However, compared to an index based on the longer scales, an index based on the subscales had identical reliability, yielded nearly identical values, and was as sensitive in detecting treatment differences in a clinical trial. The resulting instrument continues to cover disability, work, utilization, and health status, but is less than half the length of our previous comprehensive questionnaires.

Activities of Daily Living↗
PubMed1995

Health status and function with zidovudine or zalcitabine as initial therapy for AIDS. A randomized controlled trial. Roche 3300/ACTG 114 Study Group.

OBJECTIVE: To evaluate the functional and health status implications of prescribing zalcitabine or zidovudine for initial therapy of acquired immunodeficiency syndrome (AIDS). DESIGN: A substudy of a randomized controlled trial. SETTING: Private and public clinics and referral centers. PATIENTS: Had human immunodeficiency virus (HIV) infection, less than 0.20 x 10(9)/L (200 microliters) CD4+ cells, and either a history of Pneumocystis carinii pneumonia or symptoms of HIV infection. Fifty-eight percent (338/668) of main study enrollees representing 90% of enrollees at participating sites were included in this substudy. INTERVENTIONS: Either zalcitabine at 0.75 mg every 8 hours plus inactive capsules identical in appearance to zidovudine or zidovudine at 200 mg (later 100 mg) every 4 hours plus inactive tablets identical in appearance to zalcitabine. MAIN OUTCOME MEASURES: Results of a periodically completed self-report survey instrument containing specific questions about symptom impact, disability, work, functioning, and utilization as well as nine health and functioning scales adapted from the Medical Outcomes Study (MOS). RESULTS: Zalcitabine recipients were twice as likely to undergo an invasive procedure (P = .004) or be admitted to hospital (P = .01). Zalcitabine recipients reported greater than 40% more symptoms that interfered with activity (P = .001) and greater than 50% more disability days (P < .01). They also had a 7% lower employment rate and a 35% lower monthly income. Average observed health status scores were lower in zalcitabine recipients overall, but especially in the early portion of the study. New methods for combining survival and health status data showed that, over 76 weeks of study, a typical zidovudine recipient spent about 4 (10%) more weeks with at least the typical health state than did a typical zalcitabine recipient. CONCLUSIONS: Zidovudine has substantial advantages over zalcitabine in initial monotherapy of AIDS in terms of functional outcomes such as symptoms impact, disability, work, utilization, and health status. In this case, the differences in functional outcomes presaged differences in physiological and clinical measures. The inclusion of functional outcomes can greatly improve the information available from a clinical trial.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Dissemination of effectiveness and outcomes research.

Effectiveness and outcomes research seeks to improve patients' health outcomes by improving the quality of the health care they receive. Dissemination of the findings of such research is a necessary step in that process. This paper reviews what is known about designing and disseminating effective information packages aimed at health care providers (mainly physicians), where effectiveness means promoting behavior change on the part of practitioners that leads to better patient care. Practice-relevant research information is delivered to providers through publication of results from randomized clinical trials, dissemination of consensus recommendations, development and use of computer-based aids to clinical decision making, and provision of continuing medical education. Each of these areas offers numerous examples of the exceedingly modest behavioral response that can be expected from the mere provision of information. The literature also offers some principles that may improve the chances for success, including the desirability of techniques that involve face-to-face interaction, promoting the active involvement of the learner, repeating the message, making recommendations explicit and relevant to clinical practice, and making use of opinion leaders and peer influence. Little basic research has been done on providers' motivations and actual decision-making processes. Research aimed at furthering a behavioral science of providers could yield new insights on effective dissemination strategies as well.

Communication↗
PubMed1995

Comparison of health-related quality of life in clinical trial and nonclinical trial human immunodeficiency virus-infected cohorts.

Clinical trials randomly assign treatments and select participants to maximize internal validity, but such selection threatens generalizability by excluding important groups with the diseases under study. Particularly in human immunodeficiency virus (HIV) disease, the results of clinical trials are applied broadly to populations, despite limited representation by minorities and disadvantaged groups. Health-related quality of life (HRQOL), which is increasingly recognized as an important outcome in these studies, may be sensitive to differences that affect generalization of trial results to target populations. This study compared HRQOL in two HIV-infected cohorts: 1) multicenter AIDS Clinical Group Trials in which most subjects are white, privately insured, and high-income (n = 1,907); and 2) a study of ethnically diverse, low-income patients recruited from public clinics (n = 205). Both studies included 30 HRQOL items developed in the Medical Outcomes Study (MOS) and items on symptoms, medications, and demographic characteristics. HRQOL scores were significantly lower in the nontrial sample (P < 0.001) by about one standard deviation, even after direct adjustment for clinical and demographic characteristics, and also after comparison of the nontrial sample with the most symptomatic in the trial sample. The relationships of characteristics with HRQOL differed between nontrial and trial samples, suggesting problems generalizing results from HIV clinical trials to important target populations. HRQOL measures such as those from the MOS can be useful in detecting differences that affect generalization.

Acquired Immunodeficiency Syndrome↗
PubMed1995

A Windows-based tool for the study of clinical decision-making.

Studies of health-provider decision-making, and of their practice patterns, play a central role in efforts to improve the quality and effectiveness of care and in decreasing costs of healthcare delivery systems. Researchers from a variety of disciplines have studied a broad range of clinical conditions, using a number of methodological approaches and measurement tools, including self-report, written clinical vignettes, simulated clinical encounters using actors as patients and analysis of medical records and administrative data. Although these provide information about the outcomes of clinical decisions, they provide little or no information about the process of the decision. Most clinicians agree that the decision process is as important as the outcome, and indeed it is not unusual to have an exemplary process but a poor outcome. Process information is therefore a crucial dimension of care evaluation. In this paper, we describe a new software product that was originally used to measure diagnostic reasoning in the basic medical science of immunology; subsequently adapted to measure key steps in the clinical decision-making process. This Windows-based software is user-friendly, inexpensive, and requires only commonly available hardware for its operation. It is very flexible, permitting the creation of unlimited numbers and types of clinical scenarios, with diagnostic and/or management approaches. Being clinically "real-world," the scenarios are familiar to the user, who is therefore likely to respond in a "real-world" fashion, with the consequent improved accuracy of data. In addition, a wide range of users may be accommodated. The clinical activities of physicians, nurses, pharmacists, and any other clinical providers may be measured and analyzed by the system. Non-clinical providers, such as managers and administrators, could also be assessed. The system has three major modes. In the Authoring Mode, the author creates a menu, which is common to a number of linked scenarios. For example, the menu for physicians might include the History, Physical examination, Laboratory tests, Radiology, Consultations, etc. The actual details of each related clinical case may then be varied. There is virtually unlimited flexibility in the design of the menu and the clinical details, depending on the needs of the author, and the type of information desired. Both diagnostic and management scenarios are easily constructed. The cost for each individual step may be assigned, using any scoring scale desired. Actual dollar costs, or a suitable point score, are equally possible. Once the menu and associated scenarios are generated, the candidate is asked to solve the clinical problem in the User Mode. The candidate obtains information by "mouse-clicking," so it is not necessary to be a computer expert to use the system. Eventually, the candidate is presented with a short vignette outlining the desired solution, which may include the authors comments, sources for further information, etc. In the Data Collection and Analysis Mode, the candidate proceeds to solve the scenario, the software captures and stores each individual information request i.e., each step in the candidates reasoning process. Thus, the reasoning process can be examined, including timing and order and types of information used; this may be done both for individual candidates, and also for groups. A "gold standard" reasoning may be predetermined by the author for comparison purposes. The software has already been used to teach immunology to medical students, and is currently being expanded to train gynecology surgeons in the use of Clinical Practice Guidelines. The software has potential applications in many aspects of the healthcare field. For educators, it could serve in traditional exit examinations for the clinical disciplines, both undergraduate and postgraduate. (abstract truncated)

Computer-Assisted Instruction↗
PubMed1994

A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity.

Acceptance of health status as an outcome in clinical trials of new treatments for HIV disease has been hampered by the lack of valid and clinically relevant means of summarizing differences across multiple dimensions. We formed a summary Perceived Health Index from health status measures adapted from RAND Medical Outcomes Study scale and contained in the HIV-PARSE survey instrument, which had been administered to a large number of participants in clinical trials for advanced HIV disease. The psychometric properties of the included health status scales were assessed using multitrait scaling and test-retest stability. Weights for the index were derived from regressions of Current Health Perceptions on the domain-specific health status scales. The effect of participant characteristics on weights was tested. Finally, the reliability and known-clinical groups validity of the index was assessed. Data were obtained from 1,862 clinical trial participants who provided a total of 7,352 observations. The mean CD4 count was 131. The internal consistency reliability of the multi-item scales ranged from 0.86 to 0.90, and items demonstrated excellent discrimination across scales. The domain-specific scales explained 59% of the variation in the Current Health Perceptions scale (P < 0.00001). The resulting Perceived Health Index was equal to 0.20 Physical Functioning + 0.15 Pain + 0.41 Energy/Fatigue + 0.10 Emotional Well-being + 0.05 Social Functioning + 0.09 Role Functioning. The strong positive bivariate relationship between the Cognitive Function/Distress scale and the Current Health Perceptions scale was subsumed by the combination of the other domain-specific scales in multiple regressions, so it does not appear independently in the index. The proportional weights used in the index were insensitive to variations in demographics. The reliability of the index was conservatively estimated to be 0.94. Patients with index scores in the lowest quartile had a 2- to 11-fold higher probability than those in the highest quartile of reporting various specific clinical events, and the index correlated significantly more highly with the number of such events than did the current health perceptions scale. The modified MOS health status scales included in the HIV-PARSE are reliable and valid in patients with advanced HIV disease. The Perceived Health Index provides a reliable and valid means of summarizing self-reported current health, correlates strongly with clinical indicators, and should be useful as a outcome measure in patients enrolling into clinical trials of therapies for advanced HIV disease. Regression based weights are a useful means of summarizing multidimensional measures.

Adolescent↗
PubMed1990

Changing practice patterns in the management of primary breast cancer: Consensus Development Program.

In the last decade, new knowledge has emerged concerning the efficacy of treatment for breast cancer. For that reason, the National Institutes of Health devoted a consensus conference to this topic. To determine whether the consensus conference had influenced practice patterns, and to evaluate the level of quality of care given to women with breast cancer, the medical records of 573 patients treated in ten hospitals throughout the state of Washington were abstracted and analyzed. Results showed no changes with respect to the consensus conference's recommendations for use of a total mastectomy with axillary dissection or the use of a two-step procedure in which the biopsy is performed first and therapeutic options are discussed before a definitive surgery is undertaken. Analyses of quality of care issues not addressed by the consensus conference revealed that 4 percent of the sample were explicitly staged preoperatively and 29 percent postoperatively and that little changed over time in the use of sentinel laboratory tests. These results also show that consensus recommendations will not necessarily change physicians' behavior even where change is possible, and that quality of care in diagnosis and treatment of breast cancer still needs to be addressed.

Adult↗
PubMed1990

The relation between resource use and in-hospital mortality for patients with acquired immunodeficiency syndrome-related Pneumocystis carinii pneumonia.

A central issue in health policy with regard to the acquired immunodeficiency syndrome (AIDS) is whether quality of care and patient outcomes are affected by resource constraints. In an earlier study of 15 California hospitals between October 1986 and October 1987, we observed a markedly lower in-hospital mortality rate for Pneumocystis carinii pneumonia in the group of patients treated in hospitals that had a high level of experience with AIDS relative to the group treated in hospitals with low experience. We present the patterns of resource use at hospitals with high and low AIDS familiarity. Average charges and resource use did not differ between the two groups of hospitalized patients; however, there were marked variations in how the resources were used. Among survivors, patients who received care at hospitals with high AIDS familiarity stayed in the hospital longer, underwent a bronchoscopy more often, stayed in an intensive care unit longer, and accrued higher average total charges than patients at hospitals with low AIDS familiarity. Conversely, among nonsurvivors, a greater intensity of care was received at the hospitals with low AIDS familiarity. These results suggest that, in these 15 hospitals, the markedly higher rate of in-hospital death at hospitals with low AIDS familiarity was not related to the quantity of resources that were used; rather it was related to differences in how the resources were used. Our results show that additional resources significantly improved the chances of in-hospital survival for patients at hospitals with high AIDS familiarity, but did not affect the chances of survival in hospitals with low AIDS familiarity. Our findings suggest that physicians in those hospitals in which the care of patients with AIDS is relatively infrequent might improve the chances of in-hospital survival of patients with AIDS by more timely and efficient use of resources.

Acquired Immunodeficiency Syndrome↗
PubMed1989

The relation between hospital experience and in-hospital mortality for patients with AIDS-related PCP.

There is marked debate by physicians and policymakers regarding the creation of regionalized acquired immunodeficiency syndrome (AIDS) centers. A central issue is whether outcomes of care, particularly mortality, differ as a function of hospital experience with patients with AIDS. We evaluated the experience of 257 patients with AIDS and Pneumocystis carinii pneumonia treated at 15 California hospitals between October 1986 and October 1987. An overall 15.2% in-hospital mortality rate was observed. However, a markedly lower in-hospital mortality rate was observed in the group of patients treated at hospitals that had a high level of experience with patients with AIDS (greater than or equal to 30 human immunodeficiency virus-related discharges per 10,000 hospital discharges) relative to the group treated at hospitals with less experience (less than 30 human immunodeficiency virus-related discharges per 10,000 hospital discharges): 12% vs 33%. Other factors significantly associated with in-hospital mortality included intensive care unit use, admission from an emergency department or through an interhospital transfer, and a history of hospitalizations. A logistic regression model indicated that, after controlling for severity indicators, AIDS experience remained significantly related to mortality. Our findings suggest that policymakers should consider three options: creating regional AIDS centers, implementing policies that promote a rapid but carefully monitored increase in experience of low-volume hospitals with human immunodeficiency virus-infected individuals, or providing highly focused educational efforts at low-AIDS-experience facilities. Without such policy initiatives, differences in mortality rates like those we have found might persist as cases of AIDS begin to occur in every area of the country.

Acquired Immunodeficiency Syndrome↗
PubMed1988

When does information change practitioners' behavior?

Programs that disseminate information to health care practitioners often do so partly to encourage appropriate changes in practice. However, merely providing information is seldom enough to accomplish such changes. If information transfer programs are to influence practice, they must be designed to maximize the conditions facilitating change. Reliance on a diffusion model for thinking about how information reaches practitioners has led researchers to over-emphasize the importance of exposure to information and ignore other factors that determine whether change will occur, such as practitioners' motivation to change, the context in which clinical decisions are made, and how information is presented. The fact that successful dissemination will not necessarily produce change also has implications for how information transfer programs should be monitored and evaluated.

Attitude of Health Personnel↗
PubMed1988

Stylistic variations in National Institutes of Health consensus statements, 1979-1983.

This paper describes a content analysis of the statements of 24 Consensus Development Conferences conducted by the Office of Medical Applications of Research (OMAR) of the National Institutes of Health in the years 1979-1983. The goal was to understand the potential influence of the consensus statements by identifying characteristics that might determine whether and how physicians become aware of their findings and adopt their recommendations. Three characteristics emerged, each suggestive of a different style of consensus statement: discursiveness, didacticism, and scholarliness. Variations in style among consensus statements may affect their acceptance by the medical profession.

Consensus Statements as Topic↗
PubMed1987

Effects of the National Institutes of Health Consensus Development Program on physician practice.

The effects of the National Institutes of Health Consensus Development Program on physician behavior were investigated. The medical records of 2770 patients treated in ten hospitals throughout the state of Washington were reviewed to determine if quality of care improved with respect to 12 recommendations put forth by four consensus panels concerning surgical management of primary breast cancer, the use of steroid receptors in breast cancer, cesarean childbirth, and coronary artery bypass surgery. Care was studied during 24 months before and 13 to 24 months after each consensus conference. Results showed that the conferences mostly failed to stimulate change in physician practice, despite moderate success in reaching the appropriate target audience. It was concluded that the consensus development conference is an important educational tool whose effects might be enhanced by focusing on areas of practice that need improvement and by encouraging follow-up programs at the state and local level.

Breast Neoplasms↗
PubMed1986

Popular press coverage of eight National Institutes of Health consensus development topics.

The quality of medical journalism has been widely criticized. As part of a larger evaluation study, we analyzed popular press coverage of eight topics selected by the National Institutes of Health for consensus development conferences in 1979 and 1980. Using periodical indexes to identify relevant articles, we analyzed the characteristics of 269 topical articles published in newspapers and magazines in the four years surrounding each conference and examined the role that the conference played in subsequent reporting. Most topics received widespread press interest that culminated around the time of each conference. Consensus findings were widely cited in articles that appeared after the conferences. Articles were mostly factual and balanced, relied on experts, and emphasized major themes covered by the conference. We conclude that the popular press can make an important contribution to the dissemination of new medical information.

National Institutes of Health (U.S.)↗
PubMed1982

Informing patients about drug side effects.

Two hundred forty-nine newly diagnosed hypertensive patients prescribed thiazide medication were recruited for study. Two-thirds were given a leaflet or patient package insert (PPI) that described the drug and its possible side effects, and one-third were not. At a revisit about 1 month later, patients were asked whether they had experienced any of 17 different "health problems." For each problem that they experienced, they were asked whether they thought the problem was related to the medicine they were taking. Ten of the health problems were taken verbatim from the PPI's list of possible drug side effects. Patients who received the PPI reported experiencing about the same number of side effects as the non-PPI subjects. However, those who received the PPI were more likely to attribute experienced reactions to the drug. This was true for both reactions specifically listed in the PPI and for similar reactions not listed. Results support the notion of an "attribution-labeling" process rather than a "suggestion" effect.

Benzothiadiazines↗
PubMed1981

Consumer reactions to the tone of written drug information.

Emotional and cognitive reactions to four different patient package inserts (PPIs) describing flurazepam were tested. All documents contained the same basic information. However, this information was presented in a frank manner to half the subjects and in a reassuring manner to the other half. In addition, in both cases, drug side effects were presented either as a list or in paragraph form. Study subjects--456 members of a college community--each read one of the PPIs and then completed a self-administered questionnaire that had 10 multiple-choice questions about flurazepam and 19 scaled questions focusing on semantics. The frank version was judged clearer, more interesting, longer, and more appropriate for an adult audience. Tone also affected which items of information in the PPI were remembered best, possibly because it helped to establish which information was considered most important. Caution should be observed in generalizing the study conclusions until they are corroborated by research on a wider patient population.

Adult↗