Patient-reported outcomes following treatment with the human GLP-1 analogue liraglutide or glimepiride in monotherapy: results from a randomized controlled trial in patients with type 2 diabetes.

AIM: As weight gain and hypoglycaemia associated with glimepiride therapy can negatively impact weight perceptions, psychological well-being and overall quality of life in type 2 diabetes, we investigated whether liraglutide treatment could improve these factors. METHODS: Seven hundred and thirty-two patients with type 2 diabetes completed a 77-item questionnaire during a randomized, 52-week, double-blind study with liraglutide 1.2 mg (n = 245) or 1.8 mg (n = 242) compared with glimepiride 8 mg (n = 245). RESULTS: Mean (SE) decreases in glycated haemoglobin levels were greater with liraglutide 1.2 mg [-0.84 (0.08)%] and 1.8 mg [-1.14 (0.08)%] than glimepiride [-0.51 (0.08)%; p = 0.0014 and p < 0.0001, respectively]. Patients gained weight on glimepiride [mean (SE), 1.12 (0.27) kg] but lost weight on liraglutide [1.2 mg: -2.05 (0.28) kg; 1.8 mg: -2.45 (0.28) kg; both p < 0.0001]. Patient weight assessment was more favourable with liraglutide 1.8 mg [mean (SE) score: 40.0 (2.0)] than glimepiride [48.7 (2.0); p = 0.002], and liraglutide 1.8 mg patients were 52% less likely to feel overweight [odds ratio (OR) 0.48; 95% confidence interval (CI): 0.331-0.696]. Mean (SE) weight concerns were less with liraglutide [1.2 mg: 30.0 (1.2); 1.8 mg: 32.8 (1.2)] than glimepiride [38.8 (1.2); p < 0.0001 and p < 0.001, respectively], with liraglutide groups 45% less likely to report weight concern (OR 0.55, 95% CI: 0.41-0.73). Mean (SE) mental and emotional health and general perceived health improved more with liraglutide 1.8 mg [476.1 (2.8) and 444.2 (3.2), respectively] than glimepiride [466.3 (2.8) and 434.5 (3.2), respectively; p = 0.012 and p = 0.033, respectively]. CONCLUSIONS: Improved glycaemic control and decreased weight with liraglutide 1.8 mg vs. glimepiride can improve psychological and emotional well-being and health perceptions by reducing anxiety and worry associated with weight gain.

[Cardiovascular risk factors in a community in Piedmont: changes after 11 years and a comparison with other regional and national data]. / Fattori di rischio cardiovascolare in una comunità del Piemonte: variazioni a distanza di undici anni e confronto con altri dati regionali e nazionali.

BACKGROUND: In 1986 the Cardiology Department, including an outpatient clinic, was established in the community hospital of Savigliano (Italy). In 1987, as a part of a cardiovascular community prevention program, an epidemiological survey on cardiovascular risk factors was carried out. Similar indicators have been object of the study held in 1998 by ANMCO-Istituto Superiore di Sanità: the Italian Cardiovascular Epidemiological Observatory. So, 11 years later, we have had the chance to compare the changes, in the same community, of three important risk factors: tobacco smoking, arterial blood pressure, and obesity. METHODS: The 1987 survey included 280 subjects, aged 20 to 59 years. The 1998 survey has examined 200 subjects, aged 35 to 74 years. In both cases the subjects have been randomly selected from the Electoral Registers; subjects were asked to answer a questionnaire on tobacco smoking; arterial blood pressure measured using a cuff manometer was registered and weight and height have been recorded. In order to have comparable data we have only considered subjects 35 to 59 years old. RESULTS: One hundred and fifty-seven subjects (84 males and 73 females) were included in the 1987 survey and 123 (60 males and 63 females) in the 1998 survey. In 1987, the percentage of smokers was 40.7% (61.4% of males and 17.8% of females), with an average of 23.4 cigarettes/day among males and 14.7 among females. In 1998, the percentage of smokers has dropped to 18.6%, without any differences between sexes, with an average of 11.9 cigarettes/day among males and 12.7 among females. The mean values of blood pressure were lower in 1998 than in 1987 both in males (129.4/85.7 vs 138.0/88.2 mmHg) and females (119.3/80.2 vs 138.4/86.5 mmHg). Although not statistically significant, the percentage of individuals with systolic blood pressure > or = 160 mmHg or diastolic blood pressure > or = 95 mmHg was lower in 1998 (15.9% among males and 14.2% among females) than in 1987 (25.6% among males and 22.8% among females). The mean values of body mass index were unchanged (from 25.4 to 25.2 kg/m2 in males and from 23.4 to 23.1 kg/m2 in females). CONCLUSIONS: The incidence of tobacco smoking and of hypertension has shown a significant reduction in the population of Savigliano between 1987 and 1998. No significant variation was found in body mass index or in the prevalence of obesity. The distribution of these three risk factors seems to be lesser than that reported in northern Italy.

Methods and applications of quality-of-life measurement during antihypertensive therapy.

The measurement and evaluation of health-related quality of life during antihypertensive therapy has contributed to physicians' understanding of how patients respond to therapy in terms of physical, psychological, and social well-being. Comparative clinical trials of antihypertensive drug therapies have demonstrated that treatment produces no perceptible improvements in health status. Thus, the "burden" of the therapeutic regimen from the patient's perspective is greatly magnified. Research has also demonstrated that patient expectation and preference are important components of quality-of-life assessment when the purpose of this assessment is to predict or explain human behavior. Drug properties, including mechanism of action and pharmacokinetics, have been shown to influence the impact of drug side effects and the degree to which patients tolerate therapy. Researchers have attempted to standardize the construct of quality of life to have broad applications in health care policy and management; however, clinical research in hypertension should focus on the components of health-related quality of life that influence patient outcomes with regard to behaviors affecting adherence. Antihypertensive agents that maximize patient acceptance and quality of life are now available. Future quality-of-life research should be directed toward learning more about human behavior so that adherence to nonpharmacologic interventions such as diet and exercise will be enhanced.

Measuring the impact of onychomycosis on patient quality of life.

According to survey research, onychomycosis, a fungal infection of the toenail or fingernail, affects quality of life including physical and social functioning and emotional health. We developed an onychomycosis disease-specific questionnaire (ODSQ) that sensitively assessed symptom distress, functional impact, and social stigma associated with the disease. Samples of patients enrolled in a randomized controlled clinical trial were used for the psychometric evaluations. The multi-item scales were internally consistent (alpha > or = 0.80) and reproducible (ICC > 0.85). Interscale correlations between the ODSQ and generic scales were moderate and consistent with the hypothesized magnitude and directions. Construct validation, employing known groups analysis, supported the hypothesized impact of onychomycosis on three domains of quality of life: physical functioning, emotional health, and social functioning. Significant differences were found between clinically "cured", "improved", or "failed" patients, and between mycologically "eradicated" and "persistent" patients. The ODSQ was responsive to clinical change and more sensitive than derived Medical Outcomes Study Short Form-36 scales. The ODSQ provides reliable, validated and responsive information about the consequences of onychomycosis and its treatment.

Interpretation of quality-of-life outcomes: issues that affect magnitude and meaning.

When quality-of-life outcomes are used to evaluate treatment effectiveness, the importance of the treatment effect relative to other clinical factors is often difficult to assess. A major methodological issue addressed in this review is the interpretation of quality-of-life treatment effects. The problem is challenging for a number of reasons, including the subjective nature of the quality-of-life construct, the indirect way which it is assessed, the multiple sources of measurement error, the heterogeneity of the stochastic properties of longitudinal changes over the full range of the scale, the complex associations among multiple outcomes, and the lack of clearly directed therapeutic goals defined in terms of quality-of-life changes. The interpretation question can be addressed at 2 levels: measurement and inference. At the first level of measurement, it is necessary to establish the relevance of the quality-of-life metric across the distribution of changes by establishing meaningful category intervals that are important to the individual patient. The second level of inference involves an evaluation of the relative benefit of a quality-of-life improvement or the risk of a quality-of-life worsening for alternative treatments in populations in whom other issues, such as overall cost and available health resources, must also be considered. This report focuses on the quantitative issues that must be addressed in an interpretation of the treatment-related changes in quality-of-life outcomes. The conceptual framework of the problem is outlined, and problems that contribute to the interpretation dilemma are discussed.

Can you measure the quality of this life? Interview by Lauren M. Walker.

The value and application of quality of life measurements in evaluating health care remain difficult to determine and controversial. Can quality of life be measured in a meaningful way? Can improved quality of life be connected to productivity improvements or other cost factors? We talked to two of the liveliest (and most opinionated) researchers in the field of quality of life outcomes assessment. Paul C. Langley, PhD, is currently employed by 3M Pharmaceuticals as U.S. and international manager of health economics. Before that, he was director of the Program in Pharmaceutical Economics and Health Systems Research at the University of Colorado. Marcia A. Testa, MPH, PhD, is a senior lecturer in biostatistics at the Harvard School of Public Health and a consultant with Phase V Technologies Inc., a firm that assists health care organizations in outcomes trials. Here are their thoughts on the state of the art.

Defining and measuring quality of diabetes care.

The literature on diabetes mellitus has increasingly focused on the quality of diabetes care and its measurement. Serious and widespread quality problems exist throughout American medicine. Current efforts to improve will not succeed unless we undertake a major, systematic effort to overhaul how we deliver health care services, educate and train clinicians, and assess and improve quality. This article defines the components of quality of diabetes care provision and discusses approaches to their measurement individually and globally.

Kaposi's sarcoma and non-Hodgkin's lymphoma incidence trends in AIDS Clinical Trial Group study participants.

Combination therapy with protease inhibitors and nucleoside analogues dramatically suppresses plasma HIV-1 RNA and delays progression to AIDS, but the impact on HIV-associated malignancy remains to be established. We therefore examined incidence trends of Kaposi's sarcoma and non-Hodgkin's lymphoma in patients with advanced HIV infection in nine AIDS Clinical Trial Group studies of antiviral therapies for HIV and cytomegalovirus infections. Among a total of 6587 patients enrolled between November 1987 and February 1997, there were 280 cases of Kaposi's sarcoma and 68 cases of non-Hodgkin's lymphoma. Incidence rates per 100 person-years of both malignancies declined in concert with decreases in mortality, but the decreases in Kaposi's sarcoma were more profound and consistent than the decreases in non-Hodgkin's lymphoma. These data suggest that current therapies have ameliorated the incidence of Kaposi's sarcoma, but may not have had an equal effect on non-Hodgkin's lymphoma.

The effects of venlafaxine on social activity level in depressed outpatients.

BACKGROUND: Although most depression treatment outcome scales focus on symptoms, depression also affects daily functioning, social activity, and quality of life. We examined the effects of venlafaxine on social activity, general life functioning, and depressive symptoms in 2 placebo-controlled clinical trials of venlafaxine. METHOD: Subjects were 600 outpatients with major depression (DSM-III-R criteria). Treatment outcomes were examined separately in each study, primarily because of differing lengths of follow-up. RESULTS: Treatment with venlafaxine significantly improved activity level, general life functioning, and depressive symptoms. Treatment accounted for statistically significant changes in both activity level and general life functioning even after controlling for changes in depression. CONCLUSION: We provide evidence that social activity is a behavioral domain distinct from depressive symptoms and that venlafaxine improves social activity level and general life functioning in addition to its positive effects on depressive symptoms in outpatients with major depression.

Valuing quality of life and improvements in glycemic control in people with type 2 diabetes.

Outcomes research is used increasingly for assessing the health economic benefits of new therapeutic programs and interventions. The measurement properties of the outcomes assessment tools are important. If overlooked, they can mislead health care administrators and caregivers regarding the importance and value of these programs and interventions. We reviewed the literature and conducted two analyses to determine the absolute, relative, and operative quality-of-life ranges for people with type 2 diabetes. Quality of life and fasting blood glucose and HbA1c concentrations were measured at baseline and at 4, 8, and 12 weeks of treatment in 569 men and women randomized to either glipizide gastrointestinal therapeutic system (GITS) or placebo in a double-blind, multicenter clinical trial. A subgroup of 290 patients completed a diabetes-specific health states questionnaire at endpoint (week 12 or early termination) rating 10 health-state descriptions on a health thermometer scale ranging from 0 (death) to 100 (full health). Health losses at the higher end of the scale had a greater negative utility than did comparable losses at lower health states, indicating patients' strong preferences for maintaining asymptomatic or mildly symptomatic conditions. Patients rated their current health state at 83.4 +/- 0.8% of full health and indicated that a loss of 27 points below this value would prevent them from living and working as they currently do. The calibration analysis applied to the quality-of-life scales suggested that the targeted range for clinical investigation and quality-of-care evaluation must be more narrowly focused. Effect sizes as seemingly small as 2% (0.25 responsiveness units) on the absolute scale can correspond to quality-of-life losses of 15-20% on the personal operative scale. Differences in glycemic control clearly affected quality of life. Those patients with the best HbA1c responses (decreasing 1.5% or more from baseline) versus those with the worst responses (increasing 1.5% or more from baseline) were separated by 0.6 responsiveness units for the overall quality-of-life summary measure. The calibration analysis suggested that this degree of better glycemic control provides a nearly 50% gain in quality of life according to personal expectations within the operative range. In conclusion, general measures of quality of life may be too crude and insensitive to capture the important gains in health outcomes due to new therapeutic interventions and programs in diabetes. Quality-of-care evaluations for diabetes are at risk of favoring inferior programs with lower costs simply because gains or losses in health outcomes go undetected.

Quality of life and calcium channel blockade with nifedipine GITS versus amlodipine in hypertensive patients in Spain. Gastrointestinal Therapeutic System.

OBJECTIVE: Compliance with hypertension treatment is affected by treatment-related factors (complexity, side effects), efficacy and compound-specific effects that impact on quality of life. This study examined the differences in quality of life produced by two once-daily calcium channel blockers using different delivery systems: nifedipine gastrointestinal therapeutic system (GITS) and amlodipine. DESIGN: This was a double-blind, double-dummy, randomized clinical trial comparing nifedipine GITS (30 mg) and amlodipine (5 mg) for 24 weeks following a placebo run-in. Clinical, laboratory evaluations and quality-of-life data were assessed at screening, baseline randomization and three times during active therapy. SETTING: The study was conducted in 13 medical clinics in Spain. PATIENTS: The sample comprised 430 screened and 356 randomized patients with mild to moderate hypertension (diastolic blood pressure 95-114 mmHg). MAIN OUTCOME MEASURES: Change in systolic and diastolic blood pressure and in health-related quality of life were the main outcome measures. RESULTS: There were no significant differences between active treatment groups in the blood pressure changes (systolic blood pressure: nifedipine GITS -15.5 mmHg; amlodipine -15.7 mmHg). Spontaneous adverse events consistent with calcium channel blockage were not different. The nifedipine GITS group improved in all quality-of-life measures except Sexual Symptom Distress and showed a significantly greater improvement than amlodipine in overall Quality of Life (P< 0.05), General Perceived Health (P < 0.026) and its subscale Vitality (P < 0.019). The amlodipine group declined in overall Quality of Life, General Perceived Health, Vitality and Sleep Disturbance, and significantly in Sexual Symptom Distress (P < 0.045). However, this group improved in self-reported Cognitive Functioning (P=0.036), Mental Acuity (P < 0.005) and Detachment/disorientation (P=0.01). CONCLUSIONS: These results suggest compound-specific effects on quality of life that may be due to differences in the delivery system. Nifedipine GITS is short-acting (2 h half-life) and is delivered continuously over a 24 h period, while amlodipine has a half-life of 40 h, which may produce more sustained low-level effects. While a more beneficial profile was observed for nifedipine, amlodipine demonstrated potential positive effects on cognitive functioning.

Prognostic factors in the treatment of human immunodeficiency virus-associated non-Hodgkin's lymphoma: analysis of AIDS Clinical Trials Group protocol 142--low-dose versus standard-dose m-BACOD plus granulocyte-macrophage colony-stimulating factor. National Institute of Allergy and Infectious Diseases.

PURPOSE: The overall results of chemotherapy in human immunodeficiency virus (HIV)-associated non-Hodgkin's lymphoma (NHL) have been poor. To define a subgroup of patients who may have a better outcome, an analysis of prognostic factors was performed of patients treated in AIDS Clinical Trials Group (ACTG) protocol 142, a phase III randomized trial of low-dose versus standard-dose methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD) plus granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of patients with newly diagnosed HIV-associated NHL. MATERIALS AND METHODS: The following baseline variables were included as potential predictors of survival among 192 patients who received treatment: age; intravenous drug use (IVDU); specific type of sexual contact as risk factors (homosexual, bisexual, or heterosexual contact); prior AIDS diagnosis; CD4 cell count; serum lactic acid dehydrogenase (LDH); histology; Karnofsky performance status (KPS); stage; B symptoms; race (white/nonwhite); nodal involvement; extranodal involvement; number of extranodal sites; specific sites: bone marrow, liver, kidney, lung, or gastrointestinal tract; and treatment arm (standard-dose m-BACOD/low-dose m-BACOD). RESULTS: Age greater than 35 years, IVDU, stages III/IV, and CD4 cell counts less than 100/microL were adverse prognostic factors in multivariate analyses using the Cox proportional hazards model. The median overall survival for patients with none or one of the adverse factors was 46 weeks, with two was 44 weeks, and with three or four was 18 weeks. At 144 weeks, 29.5% of patients with none or one, 16.9% with two, and 0% with three or four factors were alive (P < .001). CONCLUSION: Long-term survival can be achieved in approximately one third of patients with HIV-associated NHL with favorable characteristics.

Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: a randomized, controlled, double-blind trial.

CONTEXT: Although the long-term health benefits of good glycemic control in patients with diabetes are well documented, shorter-term quality of life (QOL) and economic savings generally have been reported to be minimal or absent. OBJECTIVE: To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM). DESIGN: Double-blind, randomized, placebo-controlled, parallel trial. SETTING: Sixty-two sites in the United States. PARTICIPANTS: A total of 569 male and female volunteers with type 2 DM. INTERVENTION: After a 3-week, single-blind placebo-washout period, participants were randomized to diet and titration with either 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n = 377) or placebo (n = 192) for 12 weeks. MAIN OUTCOME MEASURES: Change from baseline in glucose and hemoglobin A1c (HbA1c) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries. RESULTS: After 12 weeks, mean (+/-SE) HbA1c and fasting blood glucose levels decreased with active therapy (glipizide GITS) vs placebo (7.5% 0.1% vs 9.3%+/-0.1% and 7.0+/-0.1 mmol/L [126+/-2 mg/dL] vs 9.3+/-0.2 mmol/L [168+/-4 mg/ dL], respectively; P<.001). Quality-of-life treatment differences (SD units) for symptom distress (+0.59; P<.001), general perceived health (+0.36; P= .004), cognitive functioning (+0.34; P=.005), and the overall visual analog scale (VAS) (+0.24; P=.04) were significantly more favorable for active therapy. Subscales of acuity (+0.38; P=.002), VAS emotional health (+0.35; P=.003), general health (+0.27; P=.01), sleep (+0.26; P=.04), depression (+0.25; P=.05), disorientation and detachment (+0.23; P= .05), and vitality (+0.22; P=.04) were most affected. Favorable health economic outcomes for glipizide GITS included higher retained employment (97% vs 85%; P<.001), greater productive capacity (99% vs 87%; P<.001), less absenteeism (losses = $24 vs $115 per worker per month; P<.001), fewer bed-days (losses = $1539 vs $1843 per 1000 person-days; P=.05), and fewer restricted-activity days (losses = $2660 vs $4275 per 1000 person-days; P=.01). CONCLUSIONS: Improved glycemic control of type 2 DM is associated with substantial short-term symptomatic, QOL, and health economic benefits.

AIDS-related Kaposi's sarcoma: prospective validation of the AIDS Clinical Trials Group staging classification. AIDS Clinical Trials Group Oncology Committee.

PURPOSE: To prospectively validate the AIDS Clinical Trials Group (ACTG) staging classification for AIDS-associated Kaposi's sarcoma (KS). PATIENTS AND METHODS: Two hundred ninety-four consecutive patients enrolled in eight ACTG therapeutic trials for AIDS-associated KS were staged prospectively according to tumor extent (T), severity of immunosuppression (I), and other systemic human immunodeficiency virus type 1 (HIV-1)-associated illness (S) and were observed for survival. Patients were classified as good risk (subscript 0) or poor risk (subscript 1) for each variable according to published ACTG criteria. Univariate and multivariate analyses were used to evaluate the associations between TIS variables and survival; additional analyses were conducted to improve the predictive value of the staging system. RESULTS: Survival was significantly shorter for patients in the poor-risk category for each of the TIS variables. Respective median survivals for patients in the good- and poor-risk categories were 27 and 15 months for T (P < .001); 40 and 13 months for I (P < .001) when I0 included CD4 counts > or = 200/microL and 22 and 16 months for S (P = .04). Multivariate analysis indicated that severity of immunosuppression gave the most predictive information but also showed that T provided significant additional predictive information in patients whose immune function was least impaired. Refined Cox models using a CD4 count of 150/microL rather than 200/microL to distinguish I0 and I1 yielded a simplified model with better fit to the observed data. CONCLUSION: The ACTG TIS classification predicts survival in patients with AIDS-associated KS; CD4 count and tumor stage provide the most predictive information. However, a lower CD4 count than the one originally proposed provides better discrimination between prognostic groups.

Measuring quality of life in early HIV disease: the modular approach.

RATIONALE: to examine the reliability and validity of the General Health Self-assessment, a modular questionnaire for self-assessment of quality of life (QoL) in human immunodeficiency virus (HIV) clinical trials and to describe the baseline QoL of participants in a large HIV clinical trial. DESIGN: the domains assessed include health perceptions, physical, psychological and role/social functioning, health care utilization and symptom distress. METHOD: 1,694 subjects with early HIV infection enrolled in the AIDS Clinical Trials Group Protocol 175 completed the scale at baseline. RESULTS: the domains demonstrated reliability, construct and discriminant validity. A worse QoL was associated with recent hospitalization and symptomatic status. Prior antiretroviral therapy was associated with higher health perceptions and well-being. The presence of symptom distress was related to lower QoL on the other scales. There was no relationship between QoL scales and the baseline CD4 count. Women showed a lower QoL than men on all scales, while ethnicity was related to differences in health perceptions and physical and psychological functioning. CONCLUSIONS: the General Health Self-assessment shows excellent potential as a measure of QoL for HIV-infected patients in clinical trials. Further research is necessary to determine the responsiveness of the scale to clinical and immunological changes in HIV-infected individuals.

Low-dose compared with standard-dose m-BACOD chemotherapy for non-Hodgkin's lymphoma associated with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group.

BACKGROUND: Reduced doses of cytotoxic chemotherapy or standard-dose therapy plus a myeloid colony-stimulating factor decreases hematologic toxicity and its complications in patients with non-Hodgkin's lymphoma associated with infection with the human immunodeficiency virus (HIV). However, the effect of reducing the doses of cytotoxic chemotherapeutic agents on clinical outcome is not known. METHODS: We randomly assigned 198 HIV-seropositive patients with previously untreated, aggressive non-Hodgkin's lymphoma to receive standard-dose therapy with methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD) along with granulocyte-macrophage colony-stimulating factor (GM-CSF; n=94) or reduced-dose m-BACOD with GM-CSF administered only as indicated (n=98). RESULTS: A complete response was achieved in 39 of the 94 assessable patients assigned to low-dose therapy (41 percent) and in 42 of the 81 assessable patients assigned to standard-dose therapy (52 percent, P= 0.56). There were no significant differences in overall or disease-free survival; median survival times were 35 weeks for patients receiving low-dose therapy and 31 weeks for those receiving standard-dose therapy (risk ratio for death in the standard-dose group=1.17; 95 percent confidence interval, 0.84 to 1.63; P=0.25). Toxic effects of chemotherapy rated grade 3 or higher occurred in 66 of 94 patients assigned to standard-dose therapy (70 percent) and 50 of 98 patients assigned to low-dose treatment (51 percent, P=0.008). Hematologic toxicity accounted for the difference. CONCLUSIONS: As compared with treatment with standard doses of cytotoxic chemotherapy (m-BACOD), reduced doses caused significantly fewer hematologic toxic effects yet had similar efficacy in patients with HIV-related lymphoma. Dose-modified chemotherapy should be considered for most HIV-infected patients with lymphoma.

Modeling fracture risk using bone density, age, and years since menopause.

INTRODUCTION: Preventive strategies are essential for reducing the incidence of osteoporosis and its consequences. However, simple algorithms that predict an individual's future risk of fractures are scarce. The purpose of the study was to define a clinical decision aid that enables physicians to project an individual's life-time fracture risk and therefore institute preventive therapies. METHODS: A predictor equation for bone loss was developed using bone mineral density (BMD), age, years since menopause, and weight. This was applied to normal and osteoporotic women, ages 40-80 years (n = 117) screened for osteoporosis studies. RESULTS: A spinal BMD cutoff of 0.86 gm/cm2 had a sensitivity of 90% and a specificity of 60% for detecting subjects with vertebral fractures and was therefore defined as a high-risk BMD. Using the parameter estimates from the above equation and an individual's clinical data, we derived prediction curves to forecast the age at which that individual would reach the above defined high-risk BMD, and therefore that person's expected number of remaining life-years at high risk for fractures. CONCLUSIONS: This study proposes a conceptual framework for the development of a clinical decision aid to provide guidelines for the prevention of osteoporosis. A longitudinal study that incorporates other variables such as prevalent fractures and biochemical markers of bone turnover would further validate this model and enhance its application.