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Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial.

Prostate cancer patients receiving androgen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment. Because physical activity improves physical and psychological well-being, a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life (QOL). No studies have evaluated an intervention to improve multiple QOL domains in patients receiving androgen ablation therapy. Active for Life After Cancer is a three-group randomized controlled trial designed to evaluate the effectiveness of a lifestyle physical activity intervention (Lifestyle Program) in improving QOL. The Lifestyle Program, a 6-month behavioral skills training group, is compared to an Educational Support Program and Standard Care. The purpose of this paper is to describe the design of the randomized trial and present baseline data that will characterize the QOL of the sample. Challenges to recruitment for the trial also will be presented and discussed.

Activities of Daily Living↗

Studies of the inner life: the impact of spirituality on quality of life.

This article defines spirituality and relates the importance of spirituality to understanding quality of life. Spirituality is examined through organizational religious activities, non-organizational activities and/or as an expression of faith. Spirituality as a variable in the study of quality of life is not a new concept; however, it has returned to the scene during recent years, and has gone through an evolutionary process.

Activities of Daily Living↗

Impact of erectile dysfunction (ED) on sexual life of female partners: assessment with the Index of Sexual Life (ISL) questionnaire.

Using the Index of Sexual Life (ISL) questionnaire specifically designed to measure the impact of erectile dysfunction (ED) on female partners' sexuality, we demonstrated that ED has a negative impact on the sexual life of female partners, specifically on their sexual satisfaction and sexual drive. Further analyses showed lower sexual satisfaction and sexual drive for women reporting a disturbance or change in their own sexual lives than for women who did not. Older women had lower scores compared to younger women, independent of whether their partner had ED or not. The ISL will be useful in treatment decisions when assessing the couple's satisfaction with treatment for ED.

Adult↗

Potential gains in life expectancy or years of potential life lost: impact of competing risks of death.

BACKGROUND: Measuring the impact of competing risks of death on society is important for setting public health policy and allocating resources. However, various indicators may result in inconsistent conclusions. The potential gains in life expectancy (PGLE) by elimination of deaths from HIV/AIDS, diseases of the heart and malignant neoplasms were compared to the years of potential life lost (YPLL) due to these causes in measuring the impact of premature death for the US population of working age (15-64 years). METHODS: The PGLE and the YPLL were computed from mortality reports (1987-1992) by race and gender group for deaths from HIV/AIDS, diseases of the heart and malignant neoplasms for the US population of working age. RESULTS: The YPLL overestimated the importance of premature deaths from HIV/AIDS compared to the PGLE. For the total US population and total US white population of working age, the YPLL were about 20-30% higher than the PGLE. However, the YPLL were about 20-30% lower than the PGLE for the US black population of working age. Furthermore the relative importance of the impact of death from various diseases may be interchanged by these two indicators. For example, for US black males of working age, the impact of deaths from HIV/AIDS by PGLE in 1992 was higher than that from malignant neoplasms and lower than that from diseases of the heart, but by using YPLL, the impact of premature deaths from HIV/AIDS was higher than that from both diseases of the heart and malignant neoplasms. CONCLUSIONS: The PGLE by elimination of deaths from diseases takes into account the competing risks on the population and it can be compared easily across populations. The YPLL is an index that does not take into account competing risks and it is also heavily influenced by the age structure and total population size. Although there are several standardization techniques proposed to improve the comparability of the YPLL across different populations, the YPLL fails to address the central issue of competing risks operating on the population. For this reason, we prefer the PGLE to the YPLL in measuring the impact of premature deaths on a population.

Acquired Immunodeficiency Syndrome↗

Long-term survival, quality of life, and quality-adjusted life-years among critically ill elderly patients.

OBJECTIVES: To assess mortality, quality of life (QOL), and quality-adjusted life-years (QALYs) for critically ill elderly patients. DESIGN: Cross-sectional survey. SETTING: A ten-bed medical-surgical intensive care unit (ICU) in a tertiary care university hospital. PATIENTS: The study group included 882 elderly patients (> or =65 yrs of age) and 1,827 controls (<65 yrs of age) treated during the period of 1995 to 2000. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Mortality was assessed during the ICU and hospital stays, and 12, 24, and 36 months after ICU discharge. The cumulative 3-yr mortality rate among the elderly (57%) was higher (p < .05) than that among the controls (40%). The majority (66%) of the elderly nonsurvivors died within 1 month after intensive care discharge. All elderly patients with day-1 Sequential Organ Failure (SOFA) scores >15 died during the ICU stay. QOL was assessed with EQ-5D and RAND-36 measures from 10 months to 7 yrs after discharge. The majority (88%) of the elderly survivors assessed their present health state as good or satisfactory; 66% found it to be similar or better than 12 months earlier, and 48% similar or better than their preadmission state. QOL measures by RAND-36 revealed that aging decreased their competencies most in physical functioning, physical role limitations, and vitality, but the elderly had better values in mental health than the controls. However, QALYs of the elderly respondents were 21% to 35% lower than the mean QALY minus 2 sd units of the age- and gender-adjusted general population. CONCLUSIONS: High age alone is not a valid reason to refuse intensive care, but the benefits perceived by intensive care seem to decrease with aging, if reflected as QALYs. However, 97% of the elderly survivors lived at home and 88% of them considered their QOL satisfactory or good after hospital discharge. Therefore, more reliable information on the outcome for the elderly is clearly needed.

APACHE↗

What impact would pancreatic beta-cell preservation have on life expectancy, quality-adjusted life expectancy and costs of complications in patients with type 2 diabetes? A projection using the CORE Diabetes Model.

OBJECTIVE: Type 2 diabetes is characterised by progressive failure of pancreatic beta-cell function against a background of insulin resistance. Multifactorial interventions, including intensive glycaemic and blood pressure control, reduce the risk of onset and progression of complications. However, current management of type 2 diabetes focuses on treatment of signs and symptoms of disease instead of targeting underlying causes. A number of newer pharmacological interventions, including thiazolidinediones and glucagon-like peptides, have shown early promise in preserving pancreatic beta-cell function. The aim of this study was to investigate the impact of stabilising beta-cell function on long-term outcomes in patients with type 2 diabetes. METHODS: The CORE Diabetes Model was used to project life expectancy (LE), quality-adjusted LE (QALE) and total lifetime complication costs (TC) for a cohort of newly-diagnosed patients with type 2 diabetes, either with a typical increase of HbA1c over time as observed in the UKPDS, or assuming stabilisation of HbA1c after diagnosis with a hypothetical new treatment, representing beta-cell function stabilisation. Costs due to diabetes-related complications (from a US third-party payer perspective), were discounted at 3% annually. Both non-discounted and discounted (at 3% annually) LE and QALE were calculated. Sensitivity analyses were performed to test the robustness of results. RESULTS: Over a time period of 50 years, in a cohort with no increase of HbA1c over time, LE and QALE were improved by mean (SD) 1.02 (0.36) and 0.96 (0.25) years, and total costs of complications were reduced by 6,377 dollars (2,568) per patient compared to the cohort with a typical increase in HbA1c over time. Results were robust under a wide range of plausible assumptions. CONCLUSIONS: New interventions that stabilise pancreatic betacell function may have an important impact on length and quality of life, and lead to reduced costs of complications in patients with type 2 diabetes.

Computer Simulation↗

Application of a quality of life measure, the life situation survey (LSS), to alcohol-dependent subjects in relapse and remission.

BACKGROUND: Recent studies have shown that quality of life (QOL) is improved significantly when subjects do not relapse to heavy drinking, and QOL deteriorates significantly on prolonged relapse. This article further investigates these relationships using a QOL index, the Life Situation Survey (LSS). METHODS: Eighty-two DSM-IV alcohol-dependent subjects admitted for alcohol detoxification were studied at baseline and 12 week follow-up. Sociodemographic data were collected, and severity of alcohol dependence (SADQ) and General Health Questionnaire (GHQ-12) were baseline indices only. The main outcome measure, the LSS, was administered at both time points. RESULTS: Two subjects were lost to follow-up and one died during the study period. Thus, the relapse/ nonrelapse analysis related to 79 subjects. Fifty subjects (63%) had relapsed to heavy drinking at 3 months follow-up. There was a significant correlation between LSS and GHQ-12 scores. Significant changes occurred in total LSS scores as a result of relapse and nonrelapse. The improvement in LSS scores associated with nonrelapse was larger than the deterioration that accompanied relapse. In those subjects who did not relapse to heavy drinking, the mean follow-up score remained in the poor/borderline LSS range. Remission from heavy drinking was accompanied by significant improvements in appetite, sleep, and self-esteem. Relapse to heavy drinking coincided with a significant deterioration in mood/affect, public support, and work/life role scores. CONCLUSION: QOL as assessed by the LSS in recently detoxified alcoholics is impaired significantly. In the nonrelapse group, there was a significant improvement in LSS scores after 3 months. Relapse was accompanied by a smaller deterioration in LSS scores. The LSS can play an important role in monitoring the clinical care and progress of alcohol-dependent subjects.

Alcoholism↗

[The relationship between years of life lost and life expectancy: applications to the analysis of mortality].

"This paper presents a new, continuous, version of the index of years of life lost (YLL) in the population, distinguishing different causes of death. Also, it shows the mathematical relationship between the YLL and temporary life expectancies in the discrete and continuous cases....The model is applied to the analysis of mortality of the province of Cordoba, Argentina, during 1947-1991." (SUMMARY IN ENG)

Americas↗

Does increased life expectancy imply active life expectancy?

From Danish results, it is argued that longer life need not imply worse health. If we as individuals and society will prevent the "pawnbroker-diseases," increase access to geriatric rehabilitation, and supply necessary services in an individualised way, most added years can be active years. The following conclusions are drawn: In the first decades after the year 2000, morbidity, disability and mortality will be postponed, but treatment will be more important for prolongation of life than prevention. Therefore, the net result will be extension of morbidity. The next question is how severe disability will be among the increased number of people who have a disease, but are not dying from it. The elderly will be more healthy in the future, but the prevalence of chronic disabling diseases may not change, or may even increase. That is because healthy men and women can postpone disability and death until higher ages (successful aging), but some elderly persons live with premature disabling diseases, which might have killed them some decades ago. When elderly people make the transition from autonomy to dependence in the course of a disease, it is possible by early geriatric intervention and rehabilitation to restore them to functional levels and provide them with more active years. It is possible to disseminate geriatric rehabilitation to a much wider population of elderly with multipathology and social problems. In this way, disability can be overcome in a higher fraction of diseased elderly.(ABSTRACT TRUNCATED AT 250 WORDS)

Activities of Daily Living↗

[Right to life vs right to a determined quality of life. Reflections on human cloning].

This article studies the bioethic divergences appeared as a consequence of the use and therapeutic obtaining of stem cells. It also chronicles the development of the cloning techniques and then, following the parameters of Bioethics, it distinguishes a categorization of the cloning with reproductive aims and cloning with therapeutic aims. It emphasizes how this problematic takes us to the beginning of human life and to the determination of the moment where this one deserves ethic recognition and legal protection. It also marks that the impact that would have the development of the therapeutic-cloning over the quality of life of sick persons and old men changes the traditional points of view. It is necessary a urgent normative with intenational validity, nevertheless the real safeguard against abuses would only be possible by the respect to human dignity by all the people who are involve in the investigation of these techniques.

Cloning, Organism↗

[Assessment of physicians employed in emergency medical services about their level of knowledge on basic life support, advanced cardiac life support and medicolegal responsibilities].

BACKGROUND: We aimed to determine the level of knowledge of Emergency Medical Services (EMS) physicians on Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and medicolegal responsibilities in conjunction with related factors. METHODS: Fifty-three physicians (43 male, 10 females; mean age 39 years; range 28 to 50 years) employed in EMS were required to respond a questionnaire consisting of demographic data and educational background. They also answered 25 multiple-choice questions about BLS, ACLS and medicolegal responsibilities of physicians in a face-to-face manner. The data were analyzed using Mann-Whitney U-test and Kruskal-Wallis Analysis of Variance test. RESULTS: Mean level of knowledge was 45.4 on a hundred-point scale. Attendance to courses covering emergency aid and working as an ambulance physician for more than one year were associated with higher levels of knowledge (p=0.012; p=0.015). CONCLUSION: In-service training should be undertaken to raise the level of knowledge of the physicians employed in rural EMS and to improve the quality of field care.

Adult↗

[Can quality of life be measured? Problems of quantitative and possibilities for qualitative assessment of quality of life in psychiatry].

In a critical review of the theoretical background and recent empirical results of quality of life research in psychiatry the problems of a onesided quantitative methodological orientation will be discussed. For the surmounting of the theoretical difficulties a dynamic model of subjective quality of life in psychiatry will be presented and according to this model the necessity of a combination of quantitative and qualitative research methods will be suggested.

Adaptation, Psychological↗

The Pediatric Cancer Quality of Life Inventory: a modular approach to measuring health-related quality of life in children with cancer.

Measurement of pediatric cancer patients' health-related quality of life (HRQL) in phase III randomized, controlled clinical trials is being recognized increasingly as an essential component in evaluating the comprehensive health outcomes of modern anti-neoplastic treatment protocols. Use of a brief core measure of HRQL plus disease-specific symptom modules is a way to assess specific HRQL outcomes with a minimum of subject burden. Demonstrating a measure's feasibility, reliability and validity also represents children's ability to provide reliable and valid responses to HRQL questions. The Pediatric Cancer Quality of Life Inventory (PCQL) Modular Approach consists of a 15-item core measure of HRQL and 2 specific symptom modules: pain and nausea. To validate a patient-report form and a parent-report form, the PCQL was administered to 291 pediatric cancer patients and to their parents. Feasibility and range of measurement, as well as patient-parent concordance, were assessed. Internal consistency reliability was assessed via Cronbach's alpha. Validity was determined by the known-groups approach and by correlating PCQL scores with days missed from school. Patients had minimal missing data, and the range of measurement for the items was good. Patient-parent concordance was large but not perfect. For both patient and parent forms, internal consistency reliability of the PCQL core scale (0.83 and 0. 86, respectively) was strong. The internal consistency reliabilities of the 2 symptom modules for both patient and parent forms were in the acceptable range for group comparisons. Regarding clinical validity, the core scale and the 2 symptom modules distinguished between patients on and off treatment for both patient and parent reports. Further, both patient and parent reports correlated with days of missed school in the past 6 and 12 months. The PCQL Modular Approach has demonstrated acceptable internal consistency reliability and clinical validity for both patient-report and parent-report forms. By implication, children are capable of providing reliable and valid responses to these HRQL questions.

Child↗

A brief spiritual beliefs inventory for use in quality of life research in life-threatening illness.

This paper reports on the initial efforts to validate a brief self-report inventory, the Systems of Belief Inventory(SBI-15R), for use in quality of life (QOL) and psychosocial research studying adjustment to illness. The SBI-15R was designed to measure religious and spiritual beliefs and practices, and the social support derived from a community sharing those beliefs. The authors proposed this scale to address the need for greater exploration of spiritual and religious beliefs in QOL, stress and coping research. Phase I: Item generation. The research team identified four domains comprised of 35 items that make up spiritual and religious beliefs and practices. The instrument was piloted in a structured interview format on 12 hospitalized patients with varying sites of cancer. Phase II: Formation of SBI-54. After these initial efforts, the research team increased the number of items to 54 and adopted a self-report format. To assess patients reactions to the questionnaire, the new version was piloted on 50 outpatients with malignant melanoma. Phase III: Initial validation. To begin establishing validation, 301 healthy individuals with no history of cancer or serious illness in the prior year were asked to complete the SBI-54 and several other instruments. A principal components analysis with varimax rotation of the SBI-54 identified two factors, in contrast to the four which were hypothesized, one measuring spiritual beliefs and practices, the other measuring social support related to the respondent's religious community. Phase IV: Item reduction of the SBI-54. A shortened version of the SBI-54 with 15 items, five from the items identifying factor I and ten from those identifying factor II, was developed to lessen patient burden. The new SBI-15 correlated highly with the SBI-54, and demonstrated convergent, divergent, and discriminant validity. Revision of SBI-15. The investigators rephrased one statement in order to broaden the applicability of the SBI-15 to patients other than those with a diagnosis of cancer, and to healthy individuals. DISCUSSION. The SBI-15R met tests of internal consistency, test-retest reliability, and convergent, divergent, and discriminant validity in both physically healthy and physically ill individuals. The SBI-15R may have value in measuring religious and spiritual beliefs as a potentially mediating variable in coping with life-threatening illness, and in the measurement of QOL.

Adaptation, Psychological↗

Quality of life in patients with prostatic cancer. A feasibility study. The Members of Quality of Life Committee of the EORTC Genitourinary Group.

BACKGROUND: In recent years, there has been a growing recognition of the need to include parameters representing the patients' view of their conditions that, therefore, are more subjective in nature. METHODS: As a first effort to introduce quality-of-life (QOL) assessment in prostatic cancer clinical trials, the European Organization for Research and Treatment of Cancer (EORTC) Genitourinary Group, in cooperation with the EORTC QOL Group, activated Protocol 30853 (orchiectomy versus goserelin acetate and flutamide in previously untreated patients with Stage M+ disease. Study Coordinator: Louis Denis). The use of patient-administered QOL questionnaires was optional, and of 327 patients, only 22% underwent pretreatment assessments. RESULTS: Psychologic distress, fatigue, social and family life, and pain are the most important to the patient on a subjective basis, and these were confirmed in relation to objective parameters. There was a discrepancy between the doctors' evaluations and the patients' opinions about subjective morbidity, namely, in regard to sexual status and pain. CONCLUSIONS: This EORTC trial revealed the reluctance of clinicians to do QOL research, partly related to feasibility problems and partly to the doctors' doubts about the value of such efforts. QOL assessment should become a mandatory part of clinical trials in prostatic cancer.

Activities of Daily Living↗

Effects of socio-demographic variables on health-related quality of life determined by the quality of life index--German version.

STUDY OBJECTIVE: The purpose of this study was to determine subjective health-related quality of life (HRQoL) in a sample of the Austrian population over 14 years of age in order to evaluate the effect of socio-demographic variables on HRQoL. DESIGN/SETTING: HRQoL was determined by means of the quality of life index-German version (QLI-Ge). The influence of socio-demographic variables on HRQoL was assessed by statistical analysis using the Kruskal-Wallis test and an analysis of variance. PARTICIPANTS: A random-quota procedure was used to get balanced representation from regions and demographic groups of the Austrian population. The sample consisted of 1049 participants, 493 men and 556 women. MAIN RESULTS: Age was found to influence the QLI-Ge total score (index score) and most individual items, with increasing age resulting in a decrease in HRQoL. Differences between the sexes were observed in three dimensions: males scored higher in 'physical well-being', 'psychological well-being' and 'occupational functioning'. Marital status impacted most items with married persons showing better values than divorced persons or singles. Profession had only a minor effect on HRQoL, the level of education showed no influence at all. CONCLUSIONS: The socio-demographic variables age, sex and objective living conditions had a major influence on subjectively rated HRQoL, whereas profession and education were found to play a minor role in this context. It is recommended that in the interpretation of studies assessing HRQoL the above-mentioned objective factors be considered. This will be of particular importance when determining the effect of a pharmacotherapy on HRQoL in patients.

Adolescent↗

The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life.

The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A 'core' instrument-the QLQ-C30-has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales ('modules') to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term 'module' is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.

Breast Neoplasms↗

Measuring quality of life in hospice patients using a newly developed Hospice Quality of Life Index.

The purpose of this study was to evaluate the validity and reliability of the newly developed Hospice Quality of Life Index (HQLI). Sixty-eight patient/caregiver dyads from one hospice were asked to fill out the HQLI on admission and after 3 weeks of hospice care. Hospice experts evaluated the items on the tool to assess content validity. The content validity index (0.83) and the alpha coefficients (r = 0.87 and 0.83) supported the validity and reliability of the HQLI. Item analysis revealed items with which patients were most satisfied and aspects of quality of life that were considered to be most important.

Adult↗