Life Cycle Assessment of a system for the extraction and transformation of Waste Water Treatment Sludge (WWTS)-derived lipids into biodiesel.

In recent years, the demand for biofuels has been growing exponentially, as has the interest in biodiesel produced from organic matrices. Particularly interesting, due to its economic and environmental advantages, is the use of the lipids present in sewage sludge as a raw material for the synthesis of biodiesel. The possible processes of this biodiesel synthesis, starting from lipid matter, are represented by the conventional process with sulfuric acid, by the process with aluminium chloride hexahydrate and by processes that use solid catalysts such as those consisting of mixed metal oxides, functionalized halloysites, mesoporous perovskite and functionalized silicas. In literature there are numerous Life Cycle Assessment (LCA) studies concerning biodiesel production systems, but not many studies consider processes that start from sewage sludge and that use solid catalysts. In addition, no LCA studies were reported on solid acid catalysts nor on those based on mixed metal oxides which present some precious advantages, over the homogeneous analogous ones, such as higher recyclability, prevention of foams and corrosion phenomena, and an easier separation and purification of biodiesel product. This research work reports the results of a comparative LCA study applied to a system that uses a solvent free pilot plant for the extraction and transformation of lipids from sewage sludge via seven different scenarios that differ in the type of catalyst used. The biodiesel synthesis scenario using aluminium chloride hexahydrate as catalyst has the best environmental profile. Biodiesel synthesis scenarios using solid catalysts are worse due to higher methanol consumption which requires higher electricity consumption. The worst scenario is the one using functionalized halloysites. Further future developments of the research require the passage from the pilot scale to the industrial scale in order to obtain environmental results to be used for a more reliable comparison with the literature data.

Experimental assessment of proton dose calculation accuracy in inhomogeneous media.

PURPOSE: Proton therapy with Pencil Beam Scanning (PBS) has the potential to improve radiotherapy treatments. Unfortunately, its promises are jeopardized by the sensitivity of the dose distributions to uncertainties, including dose calculation accuracy in inhomogeneous media. Monte Carlo dose engines (MC) are expected to handle heterogeneities better than analytical algorithms like the pencil-beam convolution algorithm (PBA). In this study, an experimental phantom has been devised to maximize the effect of heterogeneities and to quantify the capability of several dose engines (MC and PBA) to handle these. METHODS: An inhomogeneous phantom made of water surrounding a long insert of bone tissue substitute (1×10×10 cm3) was irradiated with a mono-energetic PBS field (10×10 cm2). A 2D ion chamber array (MatriXX, IBA Dosimetry GmbH) lied right behind the bone. The beam energy was such that the expected range of the protons exceeded the detector position in water and did not attain it in bone. The measurement was compared to the following engines: Geant4.9.5, PENH, MCsquare, as well as the MC and PBA algorithms of RayStation (RaySearch Laboratories AB). RESULTS: For a γ-index criteria of 2%/2mm, the passing rates are 93.8% for Geant4.9.5, 97.4% for PENH, 93.4% for MCsquare, 95.9% for RayStation MC, and 44.7% for PBA. The differences in γ-index passing rates between MC and RayStation PBA calculations can exceed 50%. CONCLUSION: The performance of dose calculation algorithms in highly inhomogeneous media was evaluated in a dedicated experiment. MC dose engines performed overall satisfactorily while large deviations were observed with PBA as expected.

Technical Note: Experimental carbon ion range verification in inhomogeneous phantoms using prompt gammas.

PURPOSE: The purpose of this study was to experimentally assess the possibility to monitor carbon ion range variations--due to tumor shift and/or elongation or shrinking--using prompt-gamma (PG) emission with inhomogeneous phantoms. Such a study is related to the development of PG monitoring techniques to be used in a carbon ion therapy context. METHODS: A 95 MeV/u carbon ion beam was used to irradiate phantoms with a variable density along the ion path to mimic the presence of bone and lung in homogeneous humanlike tissue. PG profiles were obtained after a longitudinal scan of the phantoms. A setup comprising a narrow single-slit collimator and two detectors placed at 90° with respect to the beam axis was used. The time of flight technique was applied to allow the selection between PG and background events. RESULTS: Using the positions at 50% entrance and 50% falloff of the PG profiles, a quantity called prompt-gamma profile length (PGPL) is defined. It is possible to observe shifts in the PGPL when there are absolute ion range shifts as small as 1-2 mm. Quantitatively, for an ion range shift of -1.33 ± 0.46 mm (insertion of a Teflon slab), a PGPL difference of -1.93 ± 0.58 mm and -1.84 ± 1.27 mm is obtained using a BaF2 and a NaI(Tl) detector, respectively. In turn, when an ion range shift of 4.59 ± 0.42 mm (insertion of a lung-equivalent material slab) is considered, the difference is of 4.10 ± 0.54 and 4.39 ± 0.80 mm for the same detectors. CONCLUSIONS: Herein, experimental evidence of the usefulness of employing PG to monitor carbon ion range using inhomogeneous phantoms is presented. Considering the homogeneous phantom as reference, the results show that the information provided by the PG emission allows for detecting ion range shifts as small as 1-2 mm. When considering the expected PG emission from an energy slice in a carbon ion therapy scenario, the experimental setup would allow to retrieve the same PGPL as the high statistics of the full experimental dataset in 58% of the times. However, this success rate increases to 93% when using a better optimized setup by means of Monte Carlo simulations.

The implantable cardioverter defibrillator in congestive heart failure patients in primary prevention: assessment of neuropsychological impact.

AIM: Cognitive impairment, anxiety and depression have been described in patients with congestive heart failure (CHF). The aim was to analyse the prevalence of cognitive impairment and anxiety-depression in an in-hospital CHF population before discharge attempting to correlate with the presence of an implantable cardioverter defibrillator (ICD). METHODS: All subjects underwent a mini mental state examination (MMSE), geriatric depression scale (GDS), hospital anxiety and depression scale test (HADS). RESULTS: Three-hundred and eighteen CHF patients (age 71.6 years, 195 males) were analysed. The mean New York Heart Association class (NYHA) was 2.9±0.8, left ventricular ejection fraction (LVEF) was 43.4±15.8%; brain natriuretic peptide (BNP) plasma level was 579.8±688.4 pg/mL. In 9.6% a pathological MMSE score emerged; a depression of mood in 18.2% and anxiety in 23.4% of patients were observed. An ICD was implanted in 43 (14.2%) CHF patients for primary prevention of cardiac sudden death. Patients in ICD group demonstrated a higher prevalence of renal impairment (creatinine 1.7±0.7 vs. 1.2±0.8 mg/dL; P=0.0001), lower LVEF (24.9±8.9 vs. 46.2±14.6% P=0.0001) and higher BNP (717.1±538 vs. 345.4±448.6 pg/ml; P=0.0001) but similar 6-minute walking test (338.6±81.3 vs. 345.3±114.9 m; P=0.8). An ICD intervention was registered in 9 (20.9%) patients. Although clinical parameters seemed to describe a sicker population in ICD implanted patients, from neuropsychological tests did not emerge any significant differences (P=NS for MMSE, GDS and HADS). CONCLUSION: ICD-implanted CHF patients for primary prevention did not reveal a worsening in anxiety and depression of mood demonstrating a similar cognitive performance in comparison with non-ICD implanted.

Experimental validation of the TOPAS Monte Carlo system for passive scattering proton therapy.

PURPOSE: TOPAS (TOol for PArticle Simulation) is a particle simulation code recently developed with the specific aim of making Monte Carlo simulations user-friendly for research and clinical physicists in the particle therapy community. The authors present a thorough and extensive experimental validation of Monte Carlo simulations performed with TOPAS in a variety of setups relevant for proton therapy applications. The set of validation measurements performed in this work represents an overall end-to-end testing strategy recommended for all clinical centers planning to rely on TOPAS for quality assurance or patient dose calculation and, more generally, for all the institutions using passive-scattering proton therapy systems. METHODS: The authors systematically compared TOPAS simulations with measurements that are performed routinely within the quality assurance (QA) program in our institution as well as experiments specifically designed for this validation study. First, the authors compared TOPAS simulations with measurements of depth-dose curves for spread-out Bragg peak (SOBP) fields. Second, absolute dosimetry simulations were benchmarked against measured machine output factors (OFs). Third, the authors simulated and measured 2D dose profiles and analyzed the differences in terms of field flatness and symmetry and usable field size. Fourth, the authors designed a simple experiment using a half-beam shifter to assess the effects of multiple Coulomb scattering, beam divergence, and inverse square attenuation on lateral and longitudinal dose profiles measured and simulated in a water phantom. Fifth, TOPAS' capabilities to simulate time dependent beam delivery was benchmarked against dose rate functions (i.e., dose per unit time vs time) measured at different depths inside an SOBP field. Sixth, simulations of the charge deposited by protons fully stopping in two different types of multilayer Faraday cups (MLFCs) were compared with measurements to benchmark the nuclear interaction models used in the simulations. RESULTS: SOBPs' range and modulation width were reproduced, on average, with an accuracy of +1, -2 and ±3 mm, respectively. OF simulations reproduced measured data within ±3%. Simulated 2D dose-profiles show field flatness and average field radius within ±3% of measured profiles. The field symmetry resulted, on average in ±3% agreement with commissioned profiles. TOPAS accuracy in reproducing measured dose profiles downstream the half beam shifter is better than 2%. Dose rate function simulation reproduced the measurements within ∼2% showing that the four-dimensional modeling of the passively modulation system was implement correctly and millimeter accuracy can be achieved in reproducing measured data. For MLFCs simulations, 2% agreement was found between TOPAS and both sets of experimental measurements. The overall results show that TOPAS simulations are within the clinical accepted tolerances for all QA measurements performed at our institution. CONCLUSIONS: Our Monte Carlo simulations reproduced accurately the experimental data acquired through all the measurements performed in this study. Thus, TOPAS can reliably be applied to quality assurance for proton therapy and also as an input for commissioning of commercial treatment planning systems. This work also provides the basis for routine clinical dose calculations in patients for all passive scattering proton therapy centers using TOPAS.

Objective assessment of mandibular motor control using a 'reach-and-hold' task.

Mandibular motor function is well known to be impaired in the presence of temporomandibular disorders. However, while a vast literature is available concerning accuracy of motor control in limbs, quantitative and objective assessment of mandibular motor control has been seldom performed, also because of the lack of adequate investigative tools. Aim of this work is to present a technique for reliable evaluation of the motor performance of the mandible based on a kinesiography-monitored reach-and-hold task. Nineteen healthy subjects were engaged in a task in which they had to drive a cursor on a screen by corresponding movements of the mandible in the frontal plane and reach 30 random targets sequentially displayed on the screen. The whole task was repeated three times per session in two different days. The individual performance was assessed by different indices evaluating precision and steadiness of target matching. The performance progressively improved in the three trials of the first session, further improved and stabilised in the second session, with an average positioning error of 0·59 ± 038 mm and was slightly correlated with the horizontal dimension of the mandible border movement (r = 0·55). Intraclass correlation coefficient ranged between 0·76 and 0·94 for the different indices indicating good repeatability. The kinesiographic technique allowed for objective and reliable assessment of the voluntary control of the mandible position. Its potential applications include support to the characterisation of temporomandibular disorders and to motor training and progress monitoring in rehabilitation treatments.

The impact of cancer treatment on quality of life outcomes for patients with localized prostate cancer.

PURPOSE: We evaluated the impact of localized prostate cancer treatment on general, cancer specific and symptom domains of quality of life for up to 5 years after diagnosis. MATERIALS AND METHODS: A total of 842 men from the Health Professionals Followup Study, diagnosed between 1993 and 1998, were included in cross-sectional analyses of quality of life associated with prostate cancer treatment. A subset of 146 men diagnosed after 1995 were followed prospectively. Quality of life was assessed with the Medical Outcomes Study Short-Form 36 Health Status Survey, Cancer Rehabilitation Evaluation System Short Form and University of California Los Angeles Prostate Cancer Index by mailed questionnaires. Primary treatment modality was taken from medical records and patient self-report. RESULTS: Significant treatment differences were observed in all quality of life measures, with the largest occurring in sexual, urinary and bowel symptoms. Bowel function was significantly worse in patients who received external radiation and brachytherapy compared with prostatectomy (p <0.05). Although they had better or equivalent urinary and sexual function (p <0.05), patients treated with external radiation, hormones or watchful waiting had lower generic quality of life scores in multiple domains compared with those who underwent prostatectomy. Patients who had brachytherapy had similar generic quality of life outcomes compared with prostatectomy in all domains. CONCLUSIONS: Our findings suggest that important differences in quality of life go beyond known physical symptoms associated with various prostate cancer treatment options, many of which involve making a trade-off. It is important for patients with prostate cancer and health care providers to consider these differences while making treatment decisions.

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.

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.

Direct and indirect assessment of skeletal muscle blood flow in patients with congestive heart failure.

Techniques which are currently used to measure skeletal muscle blood flow (SMBF) in patients with congestive heart failure (CHF) are neither convenient nor accurate. They have led to discrepant results in patients with congestive heart failure and are, in part, responsible for the ongoing debate regarding the factors which limit the rise in body oxygen consumption during exercise in these patients. However, direct measurement of SMBF may not be needed during exercise in patients with severe CHF. Their skeletal muscles maximally extract oxygen. Consequently, increase in oxygen consumption by the skeletal muscles is only mediated by a concomitant increase in SMBF. In patients with severe CHF, peak body oxygen consumption attained during maximal exercise closely depends on the rise in SMBF, and thus provides an indirect measurement of SMBF.

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.

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.

The nature of outcomes assessment in speech-language pathology.

In this article, the clinician/researcher dichotomy as it exists for speech-language pathology will be presented, followed by a discussion of the concept of clinical significance. Several clinical effectiveness studies will be discussed, with an emphasis on descriptive follow-up studies--one of the most prevalent types of clinical effectiveness studies used by speech-language pathologists. The American Speech-Language-Hearing Association's (ASHA) task force on treatment outcomes and cost effectiveness, developed to generate an efficacy database for speech-language pathologists, will be discussed. In addition, implications for the education of speech-language pathologists with respect to outcomes will be discussed, including areas such as course content, clinical practicums, future research needs, and continuing education. Finally, future needs in the area of outcomes assessment in speech-language pathology will be presented, particularly the need for improved measurements, follow-up studies, and further initiatives by the American Speech-Language-Hearing Association.

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)

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.

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.

Efficacy, safety, and quality-of-life assessment of captopril antihypertensive therapy in clinical practice.

Successful long-term treatment of hypertension must include consideration of individual patients' life-style interfaced with the potential for adverse drug events. In a postmarketing surveillance study, 30,515 patients received captopril monotherapy and were evaluated by 7792 physicians. Mean systolic and diastolic blood pressures were reduced 17 and 11 mm Hg, respectively. Mean diastolic blood pressure was reduced 10% for patients with mild hypertension; larger mean reductions were noted for patients with moderate (16.5%) and severe (21.5%) hypertension. Captopril therapy was equally effective in all races (white, Hispanic, and black patients), age groups, and in isolated instances of systolic hypertension. Only 4.9% of patients reporting an adverse event required discontinuation of therapy. Headache (1.8%) and dizziness (1.6%) were the most frequently reported adverse events. Quality-of-life measures improved.