Biomedical subjects

M A Testa

Publications and source records attributed to M A Testa.

At least 37 records · Page 2Linked to original sources

PubMed1996

A review of the quality-of-life aspects of urinary urge incontinence.

Urinary incontinence (UI) is prevalent and costly, occurring in 15 to 30% of the US population over the age of 60 years. Among people aged 15 to 64 years, UI occurs in 1.5 to 5% of men and 10 to 25% of women. Severe incontinence occurs in 6% of the general US population, and it is estimated that $US10 billion per year is spent in direct costs alone on care for these patients. This review presents a description of the various types of UI and describes the prevalence and costs of the condition. In addition, 3 approaches to assessing the impact of UI on quality of life are discussed, namely generic measures, disease-specific measures and qualitative approaches. We also review papers on UI and sexual functioning, UI in men, and some aspects of treatment. The review was conducted in the process of developing a new disease-specific measure for urinary urge incontinence (UUI). In general, the literature suggests that UUI has a greater impact than stress incontinence on quality of life, and that UI affects social and psychological functioning more than physical functioning. Only in a minority of individuals is the impact of UI disabling; however, most individuals with UI show significant reduction in their social functioning. Several studies suggest that the impact of UI is not solely a function of its severity, but also depends on individual coping abilities. Some studies also indicate that the social problems associated with UI grow with time, but it is not clear if that is a function of increasing severity of the condition, or the particular adaptations required for coping with this problem. An important distinction appears to be the ability of individuals to avoid public notice of their condition because of uncontrolled accidents. In summary, there is a need for a new measure of the quality-of-life impact of UUI that is based on the literature and on in-depth interviews with patients.

Aged↗

PubMed1995

Discontinuation of antihyperlipidemic drugs--do rates reported in clinical trials reflect rates in primary care settings?

BACKGROUND: Discontinuation rates for drugs used to treat chronic conditions may affect the success of therapy. However, the discontinuation rates reported in clinical trials may not reflect those in primary care settings. METHODS: We conducted a cohort study using computerized research files and medical records on 2369 new users of antihyperlipidemic therapy at two health maintenance organizations (HMOs) from 1988 through 1990. The rates of drug discontinuation in these primary care settings were compared with the rates reported in clinical trials published from 1975 through 1993, located with the Medline data base. RESULTS: In the HMOs, the one-year probability of drug discontinuation was 41 percent for bile acid sequestrants (95 percent confidence interval, 38 to 44 percent), 46 percent for niacin (95 percent confidence interval, 42 to 51 percent), 15 percent for lovastatin (95 percent confidence interval, 11 to 19 percent), and 37 percent for gemfibrozil (95 percent confidence interval, 31 to 43 percent). For the bile acid sequestrants, niacin, and gemfibrozil, the risks of discontinuation were substantially higher in the HMOs than in randomized clinical trials, in which the summary estimates of this risk were 31 percent, 4 percent, and 15 percent, respectively, for trials of one year or longer. The rates of discontinuation in open-label studies were similar to those in the HMOs. CONCLUSIONS: The discontinuation rates reported in randomized clinical trials may not reflect the rates actually observed in primary care settings. The effectiveness and tolerability of antihyperlipidemic medications should be studied further in populations that typically use the agents.

Adult↗

PubMed1995

Reproducibility of DXA absorptiometry: a model for bone loss estimates.

The enhanced precision of dual-energy X-ray absorptiometry (DXA) allows the detection of very small changes in bone mineral density (BMD). True clinical changes in BMD in patients must be evaluated with the appropriate error of variance. We evaluated the responsiveness of our measures to true bone loss using a statistical variance components model that characterizes the variability associated with error introduced by the machine, operator, and subjects. Our techniques were applied to data from a prospective study of BMD measurements on spine phantoms and on pre- and postmenopausal women performed on the same day or up to 4 weeks apart with DXA (QDR 1000W, Hologic). Our model determined that most of the error in measurements was introduced by operators' and subjects' variability rather than machine performance. The false-positive rates for true bone change are significantly reduced when the appropriate CV% is used to estimate the significance of bone loss over time. Our study underscores the need to use the appropriate precision error to evaluate the clinical significance of changes in bone mass in individual subjects over time.

Absorptiometry, Photon↗

PubMed1994

Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. The AIDS Clinical Trials Group.

BACKGROUND: Zidovudine therapy is recommended for asymptomatic patients infected with the human immunodeficiency virus (HIV) who have fewer than 500 CD4+ cells per cubic millimeter. An analysis of the quality of life associated with therapy that integrated both the effects of adverse events and the benefits of delayed disease progression might influence this recommendation. METHODS: We applied a survival analysis adjusted for the quality of life to data from a randomized trial conducted by the AIDS Clinical Trials Group. The trial compared treatment with 500 mg of zidovudine per day, 1500 mg of zidovudine per day, and placebo (Protocol 019) in 1338 asymptomatic HIV-infected patients. RESULTS: The average time with neither a progression of disease nor an adverse event (symptom or laboratory finding) was 15.7, 15.6, and 14.8 months for patients receiving placebo, 500 mg of zidovudine, and 1500 mg of zidovudine, respectively. The incidence of severe symptoms was 13.8 percent in the placebo group, 15.2 percent in the 500-mg group, and 19.9 percent in the 1500-mg group (P = 0.038). After 18 months, the 500-mg group gained an average of 0.5 months without disease progression, as compared with the placebo group, but had severe adverse events an average of 0.6 months sooner. The 500-mg group had more quality-of-life--adjusted time than the placebo group only if the time lived after the progression of disease was considered by a patient to have less value than the time after the occurrence of a severe symptom. CONCLUSIONS: For asymptomatic patients treated with 500 mg of zidovudine, a reduction in the quality of life due to severe side effects of therapy approximately equals the increase in the quality of life associated with a delay in the progression of HIV disease.

CD4-Positive T-Lymphocytes↗

PubMed1994

Methods for quality-of-life studies.

Methodologies involving the use of quality-of-life patient outcomes in observational and interventional studies of health are drawn from a large and diverse field of research methods. The multidimensional way in which quality of life is conceptualized will affect the way it is measured and the complexity of the measurement. At the earliest stages of research, one must rely on methods common to the fields of tests and measurement, survey research, psychometrics and sociometrics to measure constructs that are not directly observable. Indices measuring performance can either focus on the scale's ability to perform in noninterventional, cross-sectional studies or interventional, longitudinal studies. Indices of stability, internal consistency, responsiveness with respect to true changes in quality of life, and sensitivity to treatment effects can be used to assess the scale's adequacy as a dependent variable of interest. Respondent variability can occur due to factors such as different reporters (patient, spouse, physician), the manner and form of administration (long form vs short form; self-administration vs interview) and the assessment environment (clinic, home). Finally, since quality-of-life research often involves inferential statistics and hypothesis testing, the statistical and epidemiologic principles of good study design should be followed. In addition, one should account for the reliability, responsiveness, and the sensitivity of the scale when designing the scientific hypotheses, and should specifically address the meaning of quality-of-life effect sizes by interventional-based validation. Design considerations must address the statistical issues of power, the determination of effect sizes through validation by external criteria, longitudinal data, effects of withdrawal and early termination, ceiling and floor effects, and heterogeneity of responsiveness and sensitivity among individuals. The problem of estimating quality-of-life summary parameters for use in pharmacoeconomic models is receiving increasing attention in this era of health-care reform and fiscal restraint. While medical decision theory has used cost-effectiveness models and quality-adjusted life years since the early 1970s, estimation of population parameters to differentiate among different medical interventions is relatively new. The assessment of the patient outcomes associated with medical interventions in terms of the risks, benefits and costs will clearly be a major focus of health-care reform. Development of new methodologies in quality-of-life research should build upon the strong foundation already established in the areas of clinical research, epidemiology, biostatistics, economics and behavioral science.(ABSTRACT TRUNCATED AT 400 WORDS)

Bias↗

PubMed1994

Morning increase in ambulatory ischemia in patients with stable coronary artery disease. Importance of physical activity and increased cardiac demand.

BACKGROUND: The morning increase in asymptomatic ambulatory ischemia may be due to heightened coronary tone, increased physical activity, or both. If ambulatory ischemia is primarily due to physical activity, then alterations in the schedule of physical activity should be reflected in a corresponding alteration in the occurrence of ischemia. This study was designed to examine the relation between activity patterns and the frequency of ambulatory ischemic episodes and the effect of nadolol on these relations. METHODS AND RESULTS: A double-blind, randomized, placebo-controlled, crossover trial of nadolol versus placebo was performed in 20 patients with stable coronary artery disease. At the end of each 2-week treatment phase, patients were hospitalized for 48 hours. In the hospital, there was a regular activity day (awaken and assume normal activities at 8:00 AM) and a delayed activity day (awaken at 8:00 AM, arise at 10:00 AM, and begin normal activity at noon). Ambulatory ECG monitoring was performed throughout the hospitalization. On the regular activity day, there was a morning increase in heart rate and in the number of ischemic episodes during therapy with placebo that began at 8:00 AM. In contrast, on the delayed activity day, there was a 4-hour phase shift of the increases in heart rate and the increase in ischemic episodes (ie, at noon) corresponding to the onset of physical activities. Therapy with nadolol caused a 50% reduction in the total number of ischemic episodes (129 versus 65, placebo versus nadolol; P < .02). During nadolol therapy, there was no discernible circadian peak in the number of ischemic episodes on either activity day. During placebo treatment, 87% of ischemic episodes were preceded by an increase in heart rate > or = 5 beats per minute. Although nadolol caused a significant reduction in the total number of episodes preceded by a heart rate increase compared with placebo (99 versus 38 episodes, P < .04), this therapy was associated with a significant increase in the number of episodes not associated with a heart rate increase (15 versus 21 episodes, P < .002). CONCLUSIONS: The morning increase in ambulatory ischemic episodes is due to physical activity patterns. The majority of ischemic episodes are preceded by a heart rate increase, and it is these episodes that are primarily responsible for the morning increase in ischemia. Therapy with nadolol caused a reduction in the total number of ischemic episodes solely by reducing those episodes preceded by a heart rate increase. In contrast, nadolol caused a significant increase in the number of ischemic episodes not associated with a heart rate increase, perhaps in part because it potentiated coronary vasoconstriction.

Aged↗

PubMed1993

Quality of life and antihypertensive therapy in men. A comparison of captopril with enalapril. The Quality-of-Life Hypertension Study Group.

BACKGROUND: We conducted a multicenter trial comparing two angiotensin-converting-enzyme inhibitors to determine whether effects on quality of life during antihypertensive therapy are uniform within this pharmacologic class of agents, and to relate the effects of the drugs on quality of life to objective adverse events, such as the loss of a job or the death of a spouse. METHODS: After a four-week washout period when they received placebo, 379 men with mild-to-moderately-severe hypertension were randomly assigned to receive captopril (25 to 50 mg twice daily, with or without hydrochlorothiazide) or enalapril (5 to 20 mg per day, with or without hydrochlorothiazide) for 24 weeks. Blood pressure, quality of life, and life events were monitored. Differences between treatments were evaluated by calibrating measures of quality of life with objective life events. RESULTS: Throughout the treatment period, no differences were found in blood pressure, frequency of withdrawal of patients from the study, or major side effects. Patients treated with captopril had more favorable changes in overall quality of life, general perceived health, vitality, health status, sleep, and emotional control (P < 0.05 for each). The changes varied according to the quality of life at base line (P < 0.001); patients with a low quality of life at base line remained stable or improved with either drug, whereas those with a higher quality of life remained stable with captopril but worsened with enalapril. The quality-of-life scales correlated with life events and symptom distress (P < 0.001), and calibration analysis indicated that differences between treatments were clinically important. CONCLUSIONS: Two angiotensin-converting-enzyme inhibitors, captopril and enalapril, indistinguishable according to clinical assessments of efficacy and safety, had different effects on quality of life. Calibration with life events showed that drug-induced changes are substantial and that the different effects of these two agents on quality of life can be clinically meaningful.

Affective Symptoms↗

PubMed1993

Parallel perspectives on quality of life during antihypertensive therapy: impact of responder, survey environment, and questionnaire structure.

A multicenter clinical trial comparing nifedipine gastrointestinal therapeutic system (GITS) to atenolol was conducted to evaluate the effects of reporter (physician, patient, and spouse) and assessment of environment (clinic vs. take-home), and structure (long vs. short forms). After a 4-week single-blind, placebo washout, 394 male patients with mild-to-moderate hypertension were randomized to receive 20 weeks of either atenolol or nifedipine GITS, titrated to achieve goal blood pressure of < 90 mm hg for 8 weeks and maintained at the final dose for 12 weeks. Quality-of-life assessments included "long-form" clinical assessments by the patient, parallel "short-form," take-home, mail-back assessments by patient and spouse and a side effects and symptom distress evaluation by the physician. Patients completing 20 weeks of therapy indicated a more favorable quality-of-life profile (p < 0.05) for nifedipine GITS compared with atenolol for psychosocial, positive well-being, emotional ties, behavior/emotional control, vitality, and leisure scales using the long-form clinical assessment. The short-form, take-home, mail-back assessments were highly correlated with the clinic assessments, but their responsiveness to treatment differences was less owing to item structure and lower return rates. Spouse reports were more sensitive to treatment differences in sexual functioning with a more favorable response for patients taking nifedipine GITS (p < 0.02). Physicians were less sensitive to the overall impact of side effects, reporting only 14.9% of symptoms reported by the patient. Physician evaluation of symptoms and side effects does not provide the sensitivity required for detecting quality-of-life treatment differences.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

PubMed1992

Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. The AIDS Clinical Trials Group.

OBJECTIVE: To evaluate the effects of zidovudine therapy in patients with mildly symptomatic HIV infection using Q-TWiST (quality-adjusted: Time Without Symptoms and Toxicity). DESIGN: Analysis of a previously reported multicenter, randomized, placebo-controlled clinical trial. SETTING: Thirty-two AIDS Clinical Trial units. PATIENTS: A total of 351 patients with mildly symptomatic HIV infection were assigned to placebo, and 360 patients were assigned to zidovudine, 1200 mg/d. MEASUREMENTS: A modified Q-TWiST method for comparing treatments based on time spent without severe symptomatic adverse events and without disease progression. Zidovudine and placebo were compared in a threshold utility analysis considering reduction in quality of life associated with adverse events and disease progression. Adverse events defined by laboratory findings were distinguished from findings representing symptomatic events. RESULTS: The incidence of severe symptomatic adverse events was 22.8% for the zidovudine group and 15.1% for the placebo group (P = 0.01), but, as previously reported, zidovudine improved progression-free survival relative to placebo (at 18 months, 91% compared with 81%; P = 0.001). In an 18-month period, patients receiving zidovudine went an average of 14.5 months without disease progression or a severe symptomatic adverse event compared with 14.7 months for placebo. The zidovudine group gained 0.9 months without disease progression but lost 1.1 months due to adverse events. Within the 18-month observation period, treatment provided more Q-TWiST than placebo if the quality of life after HIV disease progression was assumed to be 10% to 20% worse than the quality of life after a severe symptomatic adverse event. CONCLUSIONS: The Q-TWiST analysis projects that quality-of-life reductions due to severe symptomatic adverse events might be balanced by the quality-of-life benefits of delayed HIV disease progression for patients who received zidovudine for mildly symptomatic HIV infection. At currently recommended doses (500 to 600 mg/d, half the dose used in this study) zidovudine therapy is likely to yield a more favorable result.

Double-Blind Method↗

PubMed1992

Interpreting pharmacoeconomic and quality-of-life clinical trial data for use in therapeutics.

Interpretation of quality-of-life (QOL) and pharmacoeconomic data for therapeutic decision making and therapeutic policy planning requires a basic understanding of the methods, assumptions and limitations of the data and associated methods of analysis. Measures of the effectiveness of different pharmaceutical agents can be modified by including functions which involve assessment of the treated individual's quality of life. These quality-adjusted effectiveness measures will alter conclusions concerning clinical decisions as well as the cost-effectiveness of the comparative agents under consideration. To provide a conceptual and analytical framework for understanding the relationship between QOL assessment and pharmacoeconomic modelling, interpretations of the quality-adjusted analyses are reviewed, conceptual and analytical models are proposed, and recommendations for using QOL data in pharmacoeconomic models are outlined. Techniques for incorporating QOL measures in pharmacoeconomic models are examined using a hypothetical model involving therapeutic assessments of antiviral treatments for individuals with HIV disease. Adjustments of effectiveness measures based upon QOL-related functions are then globally addressed using stochastic compartmental models. Three specific methods for adjustment used in therapeutic trials are reviewed. Applications of these techniques to 3 studies involving the treatment of HIV disease and hypertension are critically reviewed. Issues relevant to choosing or estimating measures of quality of life for use in pharmacoeconomic models are summarised, and research guidelines are proposed.

Clinical Trials as Topic↗

PubMed1991

Assessment of quality of life by patient and spouse during antihypertensive therapy with atenolol and nifedipine gastrointestinal therapeutic system.

To evaluate differences in efficacy, safety, and quality of life, 394 male patients with mild-to-moderate hypertension were randomized to receive 20 weeks of either atenolol or nifedipine gastrointestinal therapeutic system (GITS) in a multicenter double-blind trial. A four-week placebo washout was followed by 8 weeks of titration and 12 weeks of maintenance therapy. Quality-of-life evaluation included clinical assessments by the patient and parallel take-home assessments by patient and spouse. Blood pressure was controlled equally in both groups. The total incidence of adverse reactions was similar in both groups, but a greater percentage of nifedipine GITS patients withdrew due to peripheral edema. Patients completing 20 weeks of therapy demonstrated a more favorable quality-of-life profile (P less than .05) for nifedipine GITS over atenolol in psychosocial (P less than .01), well-being (P less than .05), general affect (P less than .05), emotional ties (P less than .01), emotional control (P less than .05), vitality (P less than .05), and leisure (P less than .05) scores. Treatment differences were particularly pronounced for patients over 50 years of age and were not fully detectable until after 14 weeks of therapy. Deterioration in quality of life was associated with withdrawal. Spouses of younger patients receiving atenolol reported deterioration in sexual satisfaction as compared to spouses of patients taking nifedipine GITS (P less than .02). Thus age, length of trial, and third-party observation are important factors in quality-of-life assessment. Comparison of adverse reactions provides an incomplete measure of how well a drug is tolerated. In contrast, findings indicate that even subtle CNS-mediated effects on mood and well-being can be detected by quality-of-life evaluation.

Adult↗

PubMed1988

Commercial research and development in times of financial restraint.

More than most other areas of medical practice, radiology depends on technology for the practice of its specialty, the effectiveness of its specialists, and the contribution it can make to medical care. Consequently, manufacturers of diagnostic imaging equipment and supplies have special importance to radiologists, and there has long been a productive interrelationship between those vendors and radiologists, resulting in rapid growth in the sophistication and effectiveness of diagnostic imaging products. Presumably because the market for imaging equipment and supplies is narrowing, in the past three years there has been some redirection of research expenditures away from pure research into applied research and product development, although absolute levels of research funding have not decreased. Understanding the theory of the firm provides an insight into how vendors might respond to changes in the size of the equipment market or the certainty of the market in the future. Because the research and development activities of these vendors are important to radiology practice, radiologists need to understand corporate behavior, just as managers of companies providing imaging equipment and supplies need to understand the requirements and concerns of their market. Finally, individuals and agencies that determine the ultimate reimbursement for diagnostic medicine should be mindful of the effect their decisions have on costs and efficiencies in this area, particularly the risk that the long-range effect on the cost and quality of medical care is quite different from that intended.

Commerce↗

PubMed1988

Measuring quality of life in hypertensive patients with diabetes.

A general health status measurement instrument which assessed quality of life components was developed for diabetic patients with hypertension. The instrument was conceptualized using a broad definition of health status including measures of physical, emotional and social well-being. Because certain antihypertensive agents can alter the metabolic state of the diabetic patient, the instrument was designed to evaluate diabetes-specific symptomatology as well as interactions between antihypertensive agents and metabolic control. The background and structure of the instrument is discussed and the basic item content outlined. A preliminary pilot study consisting of 58 volunteers including healthy normals, patients with diabetes and patients with hypertension indicated that the instrument was practical for the clinic setting and that the scales and composite scores obtained from individual item responses were internally consistent and reliable over repeated trials. Discrimination among the groups also indicated the instrument's ability to be sensitive to a broad range of responses.

Adult↗

PubMed1987

Quality of life during antihypertensive therapy: techniques for clinical assessment and evaluation.

Assessment of the impact of antihypertensive therapy upon the quality of life of the hypertensive patient can provide practical data associated with patient acceptance of therapy. For measurement purposes, quality of life is the organizing concept around which the major components relating to the patient's subjective evaluation of symptoms, functions and perceptions revolve. Substantive evaluation of quality of life involves the organization of psychometric items or questions which form the basic scales underlying these major components including, symptom distress, well-being, vitality, depression, anxiety, work performance, sexual functioning, cognition and life satisfaction.

Antihypertensive Agents↗

PubMed1987

Effects of antihypertensive medications on vitality and well-being.

The effects of captopril, methyldopa, and propranolol were assessed for sense of well-being and vitality among 626 men with mild to moderate hypertension in a multicenter, randomized, double-blind clinical trial. After a 24-week treatment period, patients taking captopril, compared with patients taking methyldopa and propranolol, scored significantly higher on measures of well-being and vitality. In addition, patients on captopril had more favorable results in being able to keep up with their work and in not feeling tired or sleepy at work. The effects of each of the drugs manifested themselves at different periods. For example, the negative effects of methyldopa on vitality were evident by week 8, whereas the negative effects did not become manifest for propranolol until week 24. On the other hand, a steady progressive improvement in vitality scores was evident at week 8 and at week 24 for patients on captopril. The findings of the study also suggest that the effects of the treatment drugs were most marked in patients who had had previous antihypertensive medications and who were on single-drug therapy during the course of the clinical trial. Further, the differences between patients taking captopril and those on methyldopa and propranolol appear to be obscured by the addition of a diuretic. The findings of the study may guide the physician in orienting his or her patient and in planning and implementing a therapeutic regimen.

Adaptation, Psychological↗

PubMed1987

Impact of antihypertensive therapy on quality of life: effect of hydrochlorothiazide.

Six hundred and twenty-six male patients with mild to moderate hypertension were enrolled in a multicentre randomized double-blind clinical trial to determine the effect of methyldopa, captopril and propranolol on the quality of life of these patients. During the 6-month trial hydrochlorothiazide was added to the treatment programme of those patients whose blood pressure was not normalized. More individuals in the captopril group (33%) required hydrochlorothiazide than in the propranolol group (22%). As a group, those individuals who required a diuretic were heavier and had higher basal and end-of-study blood pressure than those individuals requiring only monotherapy. However, the basal quality-of-life indices were similar in the six treatment subgroups. The withdrawal rate from the study was twice as high for those patients treated with propranolol and methyldopa as for those treated with captopril, whether a diuretic was added or not. More individuals requiring a diuretic experienced sexual dysfunction and a substantial worsening of their general well-being and of physical symptom indices over the 24 weeks of the study (P less than 0.01), particularly in the captopril and propranolol treatment subgroups. In summary, the present results suggest that diuretic therapy may have a greater negative impact on the quality of life of hypertensive patients than captopril, propranolol or methyldopa alone.

Adult↗

PubMed1987

Work performance, absenteeism and antihypertensive medications.

Relationships between antihypertensive medications and selected aspects of work performance and absenteeism were explored in a multicentre, randomized, double-blind, clinical trial with 626 male hypertensive patients assigned to regimens of captopril, methyldopa or propranolol, either alone or supplemented as needed by a diuretic for blood pressure control. Patients previously on antihypertensive therapy did not differ from new patients in work absenteeism, both before and throughout the clinical trial. After a 24-week treatment period patients on captopril alone improved significantly over baseline in work-performance measures of mental acuity and job satisfaction-morale, while significant worsening in the methyldopa group and no change in the propranolol group occurred among patients given these drugs alone. When 24-week changes between groups not on diuretic were compared, significant differences in the measures appeared in favour of captopril. However, patients also taking a diuretic did not differ from baseline either within or between the three groups. Withdrawal from the trial because of lethargy and fatigue was significantly greater among patients on methyldopa and propranolol than among those receiving captopril. Absenteeism did not differ between the drug groups. The study shows that there are measurable differences in the impact of the antihypertensive drugs on aspects of work performance, and it underlines the importance of considering this factor in assigning patients to therapy.

Absenteeism↗

PubMed1987

Interpreting quality-of-life clinical trial data for use in the clinical practice of antihypertensive therapy.

The use of quality-of-life indices in therapeutic trials is gaining recognition as important outcome variables for evaluating the total impact of antihypertensive therapy. While the statistical significance of treatment differentials in quality-of-life indices has been well documented, their clinical relevance still remains unclear. The interpretation of clinical trial quality-of-life treatment differentials depends on a clear understanding of the normal variability in the index due to changes in day-to-day living and the relationship between the size of the differential and shifts in population responses. Using the results from a large-scale randomized clinical trial on quality of life and antihypertensive therapy, a rationale for the interpretation of clinical trial results for use by the practicing clinician is presented.

Antihypertensive Agents↗