Biomedical subjects

D E Kanouse

Publications and source records attributed to D E Kanouse.

At least 19 recordsLinked to original sources

PubMed2001

End-of-life discussions and preferences among persons with HIV.

CONTEXT: Deficits in advance care planning leave many patients and their physicians unprepared for decisions about end-of-life care. Even though the prognosis has improved for many persons with human immunodeficiency virus (HIV) infection, a need for planning remains. OBJECTIVE: To evaluate prevalence of end-of-life discussions, use of advance directives, and preferences concerning end-of-life care and their relationship with patient demographics, clinical status, psychosocial variables, and practitioner characteristics among HIV-infected persons. DESIGN, SETTING, AND PATIENTS: Cross-sectional survey of a US probability sample of 2864, which represents 231 400 adults receiving care for HIV, conducted from January 1996 to April 1997. MAIN OUTCOME MEASURES: Communication with physician regarding end-of-life issues, completion of an advance directive, preference for aggressiveness of care, and willingness to tolerate future permanent adverse health states. RESULTS: A total of 1432 patients (50%) discussed some aspect of end-of-life care with their practitioner and 1088 (38%) completed an advance directive. Patients were more likely to complete an advance directive after a physician discussion (odds ratio [OR], 5.82; 95% confidence interval [CI], 4.50-7.52). Practitioners discussed end-of-life care less with blacks (OR, 0.57; 95% CI, 0.39-0.83) and Latinos (OR, 0.74; 95% CI, 0.55-0.98) than with whites. Women (OR, 1.39; 95% CI, 1.05-1.84) and patients with children in the household (OR, 1.53; 95% CI, 1.12-2.10) communicated the most with practitioners about end-of-life issues. Patients infected with HIV via injection drug use (OR, 0.64; 95% CI, 0.45-0.89) and those with less education communicated the least with physicians about end-of-life issues. Less denial, greater trust in one's practitioner, and longer patient-practitioner relationship were associated with more advance care planning. CONCLUSIONS: Half of all persons infected with HIV are at risk of making end-of-life decisions without prior discussions with their health care practitioners. Blacks, Latinos, intravenous drug users, and less educated individuals need advance care planning interventions in clinical HIV programs.

Adult↗

PubMed2001

Assessing symptoms before hysterectomy: is the medical record accurate?

OBJECTIVE: Our purpose was to evaluate the agreement between the documentation of symptoms leading to hysterectomy and the assessment of those symptoms by the patient. STUDY DESIGN: A retrospective study was performed of 497 women in southern California who had hysterectomies. Sensitivity, specificity, and kappa statistics were calculated for the medical records and were compared with patient interviews for the presence and severity of symptoms. RESULTS: The medical record was 93% sensitive and 61% specific for identifying bleeding and 79% sensitive and 55% specific for identifying pain. Overall agreement between physician records and patient interviews was moderate for bleeding (kappa, 0.55-0.58), fair for pain (kappa, 0.29-0.34), and poor for impairment as a result of bleeding or pain (kappa, 0.0-0.14). CONCLUSIONS: Physician overestimation of symptoms could lead to overuse of hysterectomy, whereas underestimation could result in underuse. Our results suggest that both underestimation and overestimation occur for patients with abnormal bleeding, pain, or both. If physicians accurately assess symptoms but fail to document them, examinations of appropriateness will be faulty unless patients are interviewed.

False Positive Reactions↗

PubMed2001

Changes in health-promoting behavior following diagnosis with HIV: prevalence and correlates in a national probability sample.

Diet, exercise, smoking, and substance use patterns affect the course of illness and quality of life for people with HIV. In interviews with a national probability sample of 2,864 persons receiving HIV care, it was found that most had made health-promoting changes in one or more of these behaviors since diagnosis. Many reported increased physical activity (43%) and improved diet (59%). Forty-nine percent of cigarette smokers quit or cut down; 80% of substance users did so. Desire for involvement in one's HIV care and information seeking-positive coping were the most consistent correlates of change. Other correlates varied by health practice but included health status, emotional well-being, demographics, and attitudes toward other aspects of HIV care. Most people with HIV improve their health behavior following diagnosis, but more might be helped to do so by targeting these behaviors in future interventions.

Adaptation, Psychological↗

PubMed2000

The appropriateness of recommendations for hysterectomy.

OBJECTIVE: To evaluate the appropriateness of recommendations for hysterectomies done for nonemergency and non-oncologic indications. METHODS: We assessed the appropriateness of recommendations for hysterectomy for 497 women who had the operation between August 1993 and July 1995 in one of nine capitated medical groups in Southern California. Appropriateness was assessed using two sets of criteria, the first developed by a multispecialty expert physician panel using the RAND/University of California-Los Angeles appropriateness method, and the second consisting of the ACOG criteria sets for hysterectomies. The main outcome measure was the appropriateness of recommendation for hysterectomy, based on expert panel ratings and ACOG criteria sets. RESULTS: The most common indications for hysterectomy were leiomyomata (60% of hysterectomies), pelvic relaxation (11%), pain (9%), and bleeding (8%). Three hundred sixty-seven (70%) of the hysterectomies did not meet the level of care recommended by the expert panel and were judged to be recommended inappropriately. ACOG criteria sets were applicable to 71 women, and 54 (76%) did not meet ACOG criteria for hysterectomy. The most common reasons recommendations for hysterectomies considered inappropriate were lack of adequate diagnostic evaluation and failure to try alternative treatments before hysterectomy. CONCLUSION: Hysterectomy is often recommended for indications judged inappropriate. Patients and physicians should work together to ensure that proper diagnostic evaluation has been done and appropriate treatments considered before hysterectomy is recommended.

Adult↗

PubMed2000

Propensity of HIV patients to seek urgent and emergent care. HIV Cost and Services Utilization Study Consortium.

OBJECTIVE: To assess the propensity of HIV-infected adults to seek care for common symptoms, and to determine whether they would seek care in the emergency department (ED) or with their primary care provider. DESIGN: Cross-sectional interview study. SETTING: Patients in care in the 48 contiguous United States. PARTICIPANTS: A nationally representative group of HIV- infected adults selected using multistage probability sampling. MEASUREMENTS: Subjects were interviewed between January 1996 and April 1997. Patients with advanced disease (past AIDS diagnosis and/or CD4 cell count <200/microL) and early disease were asked how they would seek care for key HIV-associated symptom complexes. Three advanced disease and 3 early disease symptom scenarios were used. MAIN RESULTS: Most advanced disease patients (78% to 87%) would seek care right away from the ED or primary care provider for the symptoms asked. Most early disease patients (82%) would seek care right away for new respiratory symptoms; fewer would do so for headache (46%) or oral white patches (62%). In a multivariate model, independent predictors of propensity to use the ED for advanced disease symptoms included African-American ethnicity (adjusted odds ratio [OR], 2.5; 95% confidence interval [95% CI], 1.8 to 3.4); less education (adjusted OR, 1.4; 95% CI, 1.1 to 1.7); drug dependence (adjusted OR, 1.4; 95% CI, 1.1 to 1.7); annual income less than $5,000 (adjusted OR, 1.5; 95% CI, 1.0 to 2.3); and lower psychological well-being (adjusted OR, 0.9; 95% CI, 0.9 to 1.0). In early disease, the following independently predicted ED use: African American (adjusted OR, 4.7; 95% CI, 3.1 to 7.1) or Hispanic ethnicity (adjusted OR 2.4; 95% CI, 1.4 to 4.3), female gender (adjusted OR, 1.6; 95% CI, 1.2 to 2.2), annual income less than $5,000 (adjusted OR, 1.8; 95% CI, 1.1 to 3. 0), and lower psychological well-being (adjusted OR, 0.9; 95% CI, 0. 8 to 1.0). CONCLUSIONS: Many patients would use the ED instead of same-day primary care for several common symptoms of HIV disease. African Americans, the poor, and patients with psychological symptoms had a higher propensity to use the ED.

AIDS-Related Opportunistic Infections↗

PubMed2000

HIV-infected parents and their children in the United States.

OBJECTIVES: This study sought to determine the number, characteristics, and living situations of children of HIV-infected adults. METHODS: Interviews were conducted in 1996 and early 1997 with a nationally representative probability sample of 2864 adults receiving health care for HIV within the contiguous United States. RESULTS: Twenty-eight percent of infected adults in care had children. Women were more likely than men to have children (60% vs 18%) and to live with them (76% vs 34%). Twenty-one percent of parents had been hospitalized during the previous 6 months, and 10% had probably been drug dependent in the previous year. Parents continued to have children after being diagnosed with HIV: 12% of all women conceived and bore their youngest child after diagnosis, and another 10% conceived before but gave birth after diagnosis. CONCLUSIONS: Clinical and support services for people affected by the HIV epidemic should have a family focus.

Adolescent↗

PubMed2000

Do consumer reports of health plan quality affect health plan selection?

OBJECTIVE: To learn whether consumer reports of health plan quality can affect health plan selection. DATA SOURCES: A sample of 311 privately insured adults from Los Angeles County. STUDY DESIGN: The design was a fractional factorial experiment. Consumers reviewed materials on four hypothetical health plans and selected one. The health plans varied as to cost, coverage, type of plan, ability to keep one's doctor, and quality, as measured by the Consumer Assessment of Health Plans Study (CAHPS) survey. DATA ANALYSIS: We used multinomial logistic regression to model each consumer's choice among health plans. PRINCIPAL FINDINGS: In the absence of CAHPS information, 86 percent of consumers preferred plans that covered more services, even though they cost more. When CAHPS information was provided, consumers shifted to less expensive plans covering fewer services if CAHPS ratings identified those plans as higher quality (59 percent of consumers preferred plans covering more services). Consumer choices were unaffected when CAHPS ratings identified the more expensive plans covering more services as higher quality (89 percent of consumers preferred plans covering more services). CONCLUSIONS: This study establishes that, under certain realistic conditions, CAHPS ratings could affect consumer selection of health plans and ultimately contain costs. Other studies are needed to learn how to enhance exposure and use of CAHPS information in the real world as well as to identify other conditions in which CAHPS ratings could make a difference.

Adolescent↗

PubMed1999

Quality of life among women undergoing hysterectomies.

OBJECTIVE: To measure the association between gynecologic conditions and quality of life in women before hysterectomy. METHODS: We retrospectively identified 482 women who had hysterectomies for nononcologic and nonemergency indications in one of nine capitated medical groups in Southern California between 1993 and 1995. Their symptoms and quality of life before hysterectomy were assessed by medical record review and telephone interview. Women were placed into four symptom-based groups (pain, bleeding, pelvic discomfort, and asymptomatic groups) and compared across six quality-of-life scales. RESULTS: Women with primary pain conditions reported the highest average role impairment compared with women with primary bleeding, pelvic discomfort, or asymptomatic conditions (8.6 days/month versus 5.0, 2.5, and 1.9 days/month, respectively; P < .05). On the five 0 to 100-point quality-of-life scales, women with primary pain conditions, compared with women with bleeding, pelvic discomfort, or asymptomatic conditions, had the highest mean levels of sexual impairment (71.5 versus 54.1, 29.6, and 17.9, respectively; P < .05) and mood impairment (55.2 versus 45.2, 34.6, and 38.1, respectively; P < .05), the poorest perception of general health (74.4 versus 60.7, 44.1, and 49.4, respectively; P < .05), and the greatest increase in severity of symptoms before hysterectomy (77.2 versus 68.7, 61.5, and 57.1, respectively; P < .05). CONCLUSION: Women's primary symptoms before hysterectomy are associated differentially with varying levels of impairment. Standardized measurement of quality of life among women with gynecologic complaints that lead to hysterectomy might help in the development of treatment guidelines and in the assessment of appropriateness and outcomes of care for those women.

Adult↗

PubMed1999

Making survey results easy to report to consumers: how reporting needs guided survey design in CAHPS. Consumer Assessment of Health Plans Study.

OBJECTIVES: CAHPS is designed to report information about health care quality from the consumer perspective. Enrollees are surveyed about their experiences with their health plan and medical care, and results are reported to other consumers choosing among health plans. Based on survey instruments designed to elicit reliable and valid information about health plan experiences from plan enrollees, the aim of the CAHPS team was to design a series of reporting products that present survey results so that consumers find the information understandable, meaningful, and useful in choosing among health plans. METHODS: Design of the survey instruments and reporting products were closely linked. The approach to reporting was based on previous research on consumers' information interests and needs in evaluating and choosing among plans. Cognitive tests were conducted with consumers to get their reactions to mock-ups of various approaches to reporting CAHPS survey results. RESULTS: Findings from previous research and cognitive testing, together with feedback from various experts and the public, were used to modify the survey questions, response options, and reporting formats to make it easier for consumers to understand and use reports. Changes included dropping topics of less interest to consumers, changing question wordings that were hard to understand, minimizing the number of different response categories, and revising questions to make them easier to group together for purposes of reporting. CONCLUSIONS: The CAHPS focus on reporting results to consumers presented an unusual challenge for survey design, requiring close coordination between instrument design and report development to produce a survey and reporting kit that serves consumers' information needs.

Adult↗

PubMed1999

HIV and people with serious mental illness: the public sector's role in reducing HIV risk and improving care.

OBJECTIVE: The paper discusses issues related to the detection, prevention of transmission, and treatment of human immunodeficiency virus (HIV) infection among persons with serious mental illness and suggests ways public mental health systems can address these issues. METHODS: MEDLINE was searched from 1980 through 1998, and all pertinent references were reviewed. RESULTS: Persons with severe mental illness are at greatly increased risk of HIV infection due to increased likelihood of high-risk sexual behaviors and injection drug use. The formidable barriers to detection and effective treatment of HIV that exist in this population can be attributed to the unique characteristics of this population, lack of knowledge and expertise among mental and physical health care providers, and fragmented mental and physical health care systems. CONCLUSIONS: In the last five years, treatments for HIV that are far more efficacious than earlier treatments have become available, making it more important for HIV infection be detected and treated among persons with serious mental illness. Public mental health systems need to implement active prevention policies and practices, educate both mental health and physical health care providers about key treatment issues, and develop effective linkages between mental and physical health care providers and systems.

Disease Susceptibility↗

PubMed1998

The sexual practices of Asian and Pacific Islander high school students.

PURPOSE: To describe the sexual behaviors, beliefs, and attitudes of Asian and Pacific Islander California high school students and to compare them to other racial/ethnic groups. METHODS: Data were collected from an anonymous self-administered survey of 2026 ninth to 12th graders in a Los Angeles County school district; 186 of the respondents described themselves as Asian and Pacific Islander. The survey was conducted in April 1992. RESULTS: A higher percentage of Asian and Pacific Islander adolescents (73%) compared with African-American (28%, p < .001), Latino (43%, p < .001), white (50%, p < .001), and other (48%, p < .001) adolescents had never had vaginal intercourse. Asian and Pacific Islander adolescents were less likely than other adolescents to report having engaged in heterosexual genital sexual activities during the prior year, including masturbation of or by a partner, fellatio with ejaculation, cunnilingus, and anal intercourse. Few students in any group reported homosexual genital sexual activities. Asians and Pacific Islanders who had had vaginal intercourse were more likely than most other groups to have used a condom at first vaginal intercourse, but Asians and Pacific Islanders had not used condoms more consistently over the prior year. Asians and Pacific Islanders were more likely to expect parental disapproval if they had vaginal intercourse and less likely to think that their peers had had vaginal intercourse. CONCLUSIONS: Asian and Pacific Islander high school students in one California school district appear to be at lower sexual risk than other racial/ethnic groups. However, a large minority are engaging in activities that can transmit disease and lead to unwanted pregnancy. Therefore, current efforts to develop culturally sensitive clinical and community-based approaches to sexual risk prevention should include Asians and Pacific Islanders.

Adolescent↗

PubMed1997

Treatment adequacy for HIV-related pneumocystis pneumonia: quality measures for inpatient care.

To develop and evaluate severity-adjusted indicators of treatment timeliness and adequacy for inpatient care of first episode of HIV-related pneumocystis pneumonia, a retrospective cohort study (n = 414) using medical record review was conducted in six California medical centers (1 January 1983-30 June 1987). Measures included patient baseline characteristics and complexity, process-of-care indicators (delay in treatment initiation and proportion of adequate treatment delivered), and overall survival of hospitalization and survival without respiratory failure. Logistic regression models of severity were developed among optimally treated patients and cross-validated. Exposure to medication with pneumocystis activity within 30 days prior to admission was protective. After controlling for pre-admission medication and severity, the average proportion of adequate pneumocystis medication delivered during the first 7 and 30 days were significant predictors of outcome in all models. Delay in treatment initiation, while not a statistically significant predictor, was associated with baseline severity. Summary measures of treatment adequacy show promise as process-of-care indicators.

AIDS-Related Opportunistic Infections↗

PubMed1997

Students' acquisition and use of school condoms in a high school condom availability program.

OBJECTIVES: To determine what students know about a condom availability program in their high school, how they react to the program, whether they obtain condoms from it, and what they do with these condoms. DESIGN: Self-administered anonymous survey conducted 1 year after the program began. SETTING: An urban California school district. PARTICIPANTS: A total of 1112 students, 9th through 12th grade, 59% of eligible students present on the survey day. MAIN OUTCOME MEASURES: History of obtaining condoms from the program, use of these condoms, knowledge about the program, and attitudes toward the program. RESULTS: Forty-eight percent of students had personally taken school condoms, and another 5% had gotten them from someone else, for a total of 53% who had obtained school condoms. Seventy percent of nonvirgins and 38% of virgins obtained condoms. Males were more likely than females to have obtained condoms (60% vs 45%). Fifty-four percent of students who had obtained school condoms had used them for sexual activity: 52% had used them for vaginal intercourse, 7% for anal intercourse, and 4% for fellatio. Students also explored school condoms without having sex, eg, removing them from the packet, putting them on fingers, or putting them on their penis or a partner's penis. Thirty-four percent of students who had used a condom for vaginal intercourse during the previous year had obtained the condom they last used from school, with more males than females reporting the school as their source (41% vs 26%). Eighty-eight percent of students knew that all students were allowed to obtain condoms, and 74% knew that parental permission was not required. Students generally supported the condom program: 88% thought the school should give out condoms, and 79% thought that if the school were to require parental permission for students to get condoms, students would get them less often than with the present system (which does not require permission). Thirteen percent agreed and 71% disagreed that "having condoms available at school makes it harder for someone who doesn't want to have sex to say no." CONCLUSIONS: Providing high school students with direct access to condoms leads to widespread use of school condoms, both for sexual activity and for exploratory activities that familiarize students with condoms. Condoms are of interest to both students who have and students who have not engaged in sexual activities for which condoms are recommended.

Adolescent↗

PubMed1996

Communication between adolescents and physicians about sexual behavior and risk prevention.

OBJECTIVES: To assess the extent to which adolescents in a nonclinical community-based population have talked with a physician about sexual behavior and risk prevention and to examine whether adolescents value these discussions and trust physicians to protect their confidentiality. DESIGN: Self-administered anonymous survey. SETTING: Urban California school district. PARTICIPANTS: A total of 2026 students in 9th to 12th grade, 98% of the eligible students present on the survey day. OUTCOME MEASURES: Discussions with physicians about sexual matters, helpfulness of discussions, trust in physicians to protect confidentiality, and knowledge about confidentiality laws. RESULTS: Thirty-nine percent of adolescents reported discussions with physicians about how to avoid getting acquired immunodeficiency syndrome from sex, 37% about using condoms for vaginal intercourse, 13% about how to use condoms, 15% about the adolescent's sex life, 13% about how to say no to unwanted sex, and 8% about sexual orientation. In addition, 8% of adolescents had been given a condom by a physician. Adolescents were more likely to report most of these topics if they had ever had vaginal intercourse or if they had a regular physician. Most adolescents (80%-90%) would find it at least a little helpful to talk with a physician about various sexual matters. Most would trust a physician to keep secret that they asked questions about sex (75%), that they were having sex (65%), or that they were using contraception (68%). Fewer would trust physicians to keep secret a sexually transmitted disease (44%) or pregnancy (44%). For adolescents who knew that physicians in their state do not have to tell parents about sexually transmitted diseases or pregnancy, levels of trust rose, but only to 54%. CONCLUSIONS: Although professional medical organizations recommend that physicians discuss sexual matters and risk prevention with their adolescent patients, most adolescents report not having received these services. Physicians should be more aggressive about discussing these topics.

Adolescent↗

PubMed1996

The sexual practices of adolescent virgins: genital sexual activities of high school students who have never had vaginal intercourse.

OBJECTIVES: The purpose of this study was to determine whether high school-aged virgins engage in sexual practices that can transmit sexually transmitted diseases, including the human immunodeficiency virus (HIV). METHODS: Data were collected from an anonymous self-administered survey of 2026 urban students in 9th through 12th grades. RESULTS: Forty-seven percent of adolescents were virgins (42% of male adolescents and 53% of female adolescents). Of those who were virgins, 29% and 31% reported that, during the prior year, they had engaged in heterosexual masturbation of a partner and masturbation by a partner, respectively. The corresponding rates for heterosexual fellatio with ejaculation, cunnilingus, and anal intercourse were 9%, 10%, and 1%. Homosexual sexual activities were rare. Condom use for fellatio was also rare. Level of risk of virgins' sexual activities was associated with illicit substance use and other non-sexual risk behaviors, even after demographic variables had been controlled. CONCLUSIONS: Few high school-aged virgins engaged in anal intercourse, but many engaged in other genital sexual activities. Some of these activities can transmit disease, and all can indicate a need for counseling about sexual decision making, risk, and prevention.

Adolescent↗

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↗