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Methods for assessing quality of life in the cardiac arrhythmia suppression trial (CAST).

The CAST was a randomized, double-blind placebo-controlled multicentre trial of antiarrhythmic medications designed to suppress ventricular arrhythmias in patients after an acute myocardial infarction (MI). A collection of 21 items derived from established scales was used to assess aspects of quality of life in CAST. The questions focused on symptoms, mental health, physical functioning, social functioning, life satisfaction, and life expectancy. Additional aspects included exposure to major stressful life events, and perceived social support and social integration. Work status was also recorded. Using the baseline values of 1465 (98%) out of 1498 patients enrolled in the CAST main study between 15 June 1987 and 19 April 1989, the reliability and validity of the scales used in CAST were computed. High internal consistency reliability (> or = 0.70) was found for Symptoms, Mental Health, and Physical Functioning. The discriminative validity, in particular for Symptoms, Mental Health, Physical and Social Functioning, showed that patients with heart failure and previous MI, as well as those suffering from angina and dyspnea, had a worse quality of life than those patients who were not experiencing these symptoms. It was concluded that the scales selected to form the CAST quality of life questionnaire were both reliable and clinically valid for this patient population and therefore could be used to detect disease progression and treatment effects.

Aged↗

The tools of disability outcomes research functional status measures.

OBJECTIVE: To review the major functional status measures currently used in rehabilitation research, including the domains and scope of functional status measures, as well as the psychometric properties of selected functional status measures and their use in adult rehabilitation populations. DATA SOURCES: Measures of physical functioning widely used in rehabilitation research. STUDY SELECTION: Major generic measures included the following activities of daily living and instrumental activities of daily living: the FIM instrument, the Katz Activities of Daily Living Scale, the Level of Rehabilitation Scale, the Barthel index, and the Patient Evaluation and Conference System. Measures were evaluated based on published evidence of validity, reliability, and sensitivity. DATA EXTRACTION: Measures were chosen on the basis of the amount and quality of published research on the functional measures widely used in rehabilitation medicine. Independent research of computer databases and reviews of functional measures were conducted to determine suitability for inclusion. The quality and validity of the measures were assessed using standard psychometric guidelines. DATA SYNTHESIS: Measures were evaluated based on published evidence of validity, reliability, sensitivity response and administrative burdens and instrument bias. Each criterion was graded on a 3-point scale reflecting the level of evidence. CONCLUSION: Researchers in the field of disabilities research need to consider carefully study objectives when measuring physical functioning in people with disabilities.

Activities of Daily Living↗

Health-related quality of life in WHO class II-III obese men losing weight with very-low-energy diet and behaviour modification: a randomised clinical trial.

OBJECTIVE: To study health-related quality of life responses to marked weight loss in WHO Class II-III (body mass index (BMI) > or = 35 kg/m2) obese men. DESIGN: An 8 month randomised clinical trial with a 4 month weight loss programme (10 weeks on a very-low-energy diet (VLED) and 17 behaviour modification visits) in the treatment group and no intervention in the control group. SUBJECTS: Nineteen men (mean age 45.9 y, mean BMI 39.3 kg/m2) in the treatment group and 19 men (47.2 y, 39.4 kg/m2) in the control group. MEASUREMENTS: Weight and questionnaires measuring health-related quality of life (RAND 36-Item Health Survey 1.0 and obesity-related psychosocial problems scale). RESULTS: In the treatment group, the mean (s.d.) weight loss was 17.0 (7.4)% at the end of the 4 month therapy. At the end of follow-up, nearly 6 months after the end of VLED in the treatment group, the average maintained weight loss was 13.9 (7.8)% of baseline weight. The control group was weight stable throughout the study. During treatment, there was only transient improvement in general health, bodily pain, mental health, emotional role functioning and vitality (all increases in the scores were not statistically significant). Improvements in physical functioning, social functioning and obesity-related psychosocial problems were maintained until the end of follow-up. The treatment group also reported improvement in perceived health in the past year. There was only minor fluctuation in questionnaire scores in the control group. CONCLUSION: The short-term and maintained health-related quality of life effects of weight loss may differ. Marked weight loss in WHO Class II-III obese men leads to improvements in physical functioning, social functioning, obesity-related psychosocial problems, and perceived health; these improvements were maintained at 4 month post-intervention follow-up.

Adolescent↗

Balance confidence improves with resistance or agility training. Increase is not correlated with objective changes in fall risk and physical abilities.

BACKGROUND: While the fear of falling is a common psychological consequence of falling, older adults who have not fallen also frequently report this fear. Fear of falling can lead to activity restriction that is self-imposed rather than due to actual physical impairments. Evidence suggests that exercise can significantly improve balance confidence, as measured by falls-related self-efficacy scales. However, there are no prospective reports that correlate change in balance confidence with changes in fall risk and physical abilities as induced by participating in a group-based exercise program. OBJECTIVE: The primary purpose of this prospective study was to examine the relationship between the change in balance confidence and the changes in fall risk and physical abilities in older women with confirmed low bone mass after 13 weeks of exercise participation. The secondary purpose of this study was to examine the relationship between the change in balance confidence and the change in physical activity level. METHODS: The sample comprised 98 women aged 75-85 years with low bone mass. Participants were randomly assigned to one of three groups: resistance training (n = 32), agility training (n = 34), and stretching (sham) exercises (n = 32). The 50-min exercise classes for each study arm were held twice weekly at a local YMCA community centre. RESULTS: Both resistance training and agility training significantly improved balance confidence by 6% from baseline after 13 weeks. However, the change in balance confidence was only weakly correlated with improved general physical function and not significantly correlated with the changes in fall risk score, postural stability, gait speed, or physical activity level. As well, we observed balance confidence enhancement in the presence of increased fall risk or deterioration in physical abilities. CONCLUSIONS: Two different types of exercise training improved balance confidence in older women with low bone mass. This change in balance confidence was significantly correlated with change in general physical function. Because of the observation of discordance between balance confidence change and changes in fall risk and physical abilities, those who design group-based exercise programs for community-dwelling older adults may wish to consider including an education component on factors that influence fear of falling. Objective changes in fall risk factors cannot be assumed to mirror change in fear of falling and physical abilities in older adults in the short-term.

Accidental Falls↗

Measuring functional outcomes in therapeutic trials for chronic disease.

For clinical trials of many chronic diseases, the outcome of greatest interest may be patient function. Unfortunately, most scales for measuring functional status are crude and rarely consider important psychosocial impacts of disease. This paper briefly considers the pressures for improving functional status measurement, proposes six criteria for assessing functional or "health status" scales, and selectively reviews representative instruments using these criteria. Older functional classifications and many scales used for quality-of-care assessment are narrowly focussed on physical function. Their reliability, validity, and sensitivity to clinical changes are generally unknown. Traditional scales of "Activities of Daily Living" are similarly focussed on physical function, and are most appropriate for severely disabled inpatients. A new generation of "health status" instruments offers wider applicability, more comprehensiveness, and feasibility for clinical applications. Their validity and reliability are generally quite good. None of the instruments reviewed, however, has yet demonstrated convincing success as a "transition" variable (sensitivity to small but clinically important changes). Based on this analysis, future investigation should seek to (1) define the optimal balance between brevity on the one hand, and comprehensiveness and reliability on the other, (2) describe the sensitivity of scales to clinically important changes, and (3) directly compare existing instruments to aid selection by investigators who are considering their use in clinical trials.

Activities of Daily Living↗

Physiological improvements and health benefits during an exercise-based comprehensive rehabilitation program in medically complex patients.

OBJECTIVES: To determine the effects of an exercise-based comprehensive rehabilitation program on the physiological, health, and cost benefit in medically complex patients. DESIGN: Case series SETTING: Comprehensive rehabilitation centers. PARTICIPANTS: Elderly chronically ill men (n = 39, age = 75.3 +/- 1.4) and women (n = 74, age = 76.5 +/- 0.9 years). INTERVENTION: Patients participated in individualized physical therapy with therapeutic exercises (stretching, strengthening, endurance, balance, sitting and standing dynamic exercises) three times/week for three months under the supervision of a physician. MEASUREMENTS: Upper (back) and lower (leg flexors) extremity strength, aerobic power as measured by metabolic equivalents (METS) at 80% of age predicted maximal heart rate (APMHR), physical functioning and mental health as assessed by the Short Form-36 (SF-36) questionnaire, and medical events (falls, physician visits, and hospitalizations) questionnaire was collected at baseline and after three months of the program. RESULTS: Strength measures improved by approximately 30% (P < 0.05) as well as aerobic power improved by approximately 25% (P < 0.05) over the three-month period. There were significant improvements in two of the SF-36 Physical Component Scales: Physical Functioning (P < 0.05) and Role Physical (P < 0.05); plus, there were significant improvements in all four of the Mental Component Scales: Vitality (P < 0.05), Social Functioning (P < 0.05), Role Emotional (P < 0.05), and Mental Health (P < 0.05). There were significant reductions in fall rate (P < 0.05), physician visits (P < 0.05), and hospitalizations (P < 0.05). CONCLUSION: Patients improve physical capacity, which result in improvements in health status with concurrent reductions in healthcare utilization during a comprehensive rehabilitation program.

Aged↗

Acute delirium and functional decline in the hospitalized elderly patient.

BACKGROUND: Delirium is often considered a transient cognitive syndrome. Its effect on long-term physical function, however, has not been well defined. METHODS: In a prospective study of 325 hospitalized community and nursing home elderly, we analyzed the effect of in-hospital delirium on subsequent physical function. ADL performance was assessed prior to admission, and at 3 and 6 months after hospital discharge. RESULTS: There was a strong univariate (unadjusted) association between incident delirium and functional decline (p < .02). Delirious subjects lost a mean of almost one ADL, as measured 3 months after hospital discharge. Using multivariate linear regression analysis, with adjusted change in function as the dependent variable, delirium persisted as the sole predictor of loss of function (p = .009) at 3 months after discharge. The functional decline persisted at 6 months after hospital discharge. CONCLUSION: This finding of a nontransient, perhaps permanent consequence of delirium invites reexamination of the definition of delirium from that of an acute, reversible syndrome to one of acute onset with long-term sequelae.

Activities of Daily Living↗

Human macrophage function and physical exercise: phagocytic and histochemical studies.

Macrophages derived from human connective tissue were assayed for their enzyme content and phagocytic activity after physical exercise. A single exhaustive endurance-running test caused increased phagocytic and enzymatic activities of the macrophages. Thus, an exercise challenge activates the functional status of the cells. This effect of physical exercise on macrophages is inconsistent with the practical experience that high performance athletes suffer more frequently from harmless infectious diseases.

Adult↗

Physical and functional association of LFA-1 with DNAM-1 adhesion molecule.

Whereas ligation of the DNAM-1 adhesion molecule triggers cytotoxicity mediated by normal NK and T cells, this function was defective in NK cell clones from leukocyte adhesion deficiency syndrome. However, genetic reconstitution of cell surface expression of LFA-1 restored the ability of DNAM-1 to initiate anti-DNAM-1 mAb-induced cytotoxicity, indicating a functional relationship between DNAM-1 and LFA-1. Further studies demonstrated that LFA-1 physically associates with DNAM-1 in NK cells and anti-CD3 mAb stimulated T cells, for which serine phosphorylation of DNAM-1 plays a critical role. In addition, cross-linking of LFA-1 induces tyrosine phosphorylation of DNAM-1, for which the Fyn protein tyrosine kinase is responsible. These results indicate that DNAM-1 is involved in the LFA-1-mediated intracellular signals.

Animals↗

Assessing mobility in older adults: the UAB Study of Aging Life-Space Assessment.

BACKGROUND AND PURPOSE: The University of Alabama at Birmingham (UAB) Study of Aging Life-Space Assessment (LSA) is a relatively new instrument to measure mobility. The purpose of this report is to describe the relationships between LSA and traditional measures of physical function, sociodemographic characteristics, depression, and cognitive status. SUBJECTS: Subjects were a stratified random sample of 998 Medicare beneficiaries aged > or =65 years. The sample was 50% African American, 50% male, and 50% from rural (versus urban) counties. METHODS: In-home interviews were conducted. Mobility was measured using the LSA, which documents where and how often subjects travel and any assistance needed during the 4 weeks prior to the assessment. Basic activities of daily living (ADL) and instrumental activities of daily living (IADL), cognitive status, income level, presence of depressive symptoms, and transportation resources were determined. The Short Physical Performance Battery (SPPB) was used to assess physical performance. RESULTS: Simple bivariate correlations indicated a significant relationship between LSA and all variables except residence (rural versus urban). In a regression model, physical function (ADL, IADL) and physical performance (SPPB) accounted for 45.5% of the variance in LSA scores. An additional 12.7% of the variance was explained by sociodemographic variables, and less than 1% was explained by cognition and depressive symptoms. DISCUSSION AND CONCLUSION: The LSA can be used to document patients' mobility within their home and community. The LSA scores are associated with a person's physical capacity and other factors that may limit mobility. These scores can be used in combination with other tests and measures to generate clinical hypotheses to explain mobility deficits and to plan appropriate interventions to address these deficits.

Activities of Daily Living↗

Relationship between functional ability and physical fitness in juvenile idiopathic arthritis patients.

OBJECTIVE: To determine the relationship between aerobic and anaerobic physical fitness and functional ability in children with juvenile idiopathic arthritis (JIA). METHODS: Eighteen children with JIA (age 7 to 14 yr., 3 male/15 female) performed a maximal aerobic exercise test and a Wingate anaerobic exercise test. Functional ability was concurrently assessed using the Childhood Health Assessment Questionnaire (CHAQ). RESULTS: A low relationship between aerobic fitness and functional ability was found (r = 0.0 to 0.4, p > 0.05, except for eating r = 0.46, p < 0.05). The correlations between anaerobic physical fitness and functional ability in JIA patients were strong (r = 0.5 to 0.75, p < 0.05). This indicated a good relationship between anaerobic fitness and functional ability. CONCLUSION: The strong association between anaerobic physical fitness and functional ability showed the importance of anaerobic physical fitness for children with JIA.

Activities of Daily Living↗

Health related quality of life in multiple musculoskeletal diseases: SF-36 and EQ-5D in the DMC3 study.

OBJECTIVE: To examine the health related quality of life of persons with one or more self reported musculoskeletal diseases, as measured by the short form 36 item health status survey (SF-36) and the Euroqol questionnaire (EQ-5D). METHODS: A sample of Dutch inhabitants aged 25 years or more (n = 3664) participated in a questionnaire survey. Twelve lay descriptions of common musculoskeletal diseases were presented and the subjects were asked whether they had ever been told by a physician that they had any of these. Their responses were used to assess the prevalence of these conditions. Commonly used scores of SF-36 and descriptive scores from EQ-5D are presented, along with standardised differences between disease groups and the general population. RESULTS SUBJECTS: with musculoskeletal diseases had significantly lower scores on all SF-36 dimensions than those without musculoskeletal disease, especially for physical functioning (SF-36 score (SE), 75.2 (0.5) v 87.8 (0.5)); role limitations caused by physical problems (67.1 (0.9) v 85.8 (0.8)); and bodily pain (68.5 (0.5) v 84.1 (0.5)). The worst health related quality of life patterns were found for osteoarthritis of the hip, osteoporosis, rheumatoid arthritis, and fibromyalgia. Those with multiple musculoskeletal diseases had the poorest health related quality of life. Similar results were found for EQ-5D. CONCLUSIONS: All musculoskeletal diseases involve pain and reduced physical function. The coexistence of musculoskeletal diseases should be taken into account in research and clinical practice because of its high prevalence and its substantial impact on health related quality of life.

Adult↗

Patient-reported quality of life early in dialysis treatment: effects associated with usual exercise activity.

The purpose of this study was to investigate factors associated with quality of life (QoL) early in treatment in a cohort of incident (i.e. newly diagnosed) dialysis patients. This multicenter study investigated QoL reported by patients on chronic hemodialysis (HD) and peritoneal dialysis (PD) at approximately 60 days following the start of treatment. QoL was assessed by the Medical Outcomes Study Short-Form 36 (MOS-SF 36) and by disease-targeted scales from the Kidney Disease Quality of Life (KDQOL). Patient's QoL as measured by the SF-36 was substantially impaired compared to norms for the general population. In univariate analyses, patients' QoL scores were related to demographic variables (age, race, sex, educational level), clinical variables (predialysis BUN and serum creatinine, primary diagnosis of diabetes, cardiovascular comorbidity, average hematocrit and serum albumin in first months of treatment), dialysis variables (HD/PD modality, PD dialysis adequacy, facility patient-staff ratio) and patient's level of usual exercise activity. In multivariate analyses, the most important independent QoL predictor was patient's usual level of exercise activity. Exercise activity independently predicted two performance measures of physical functioning, maximal gait speed and repeated chair rises, as well as patient-perceived physical functioning. Continued study of patient outcomes in relation to adequacy of delivered dialysis, early versus late diagnosis of chronic renal failure (CRF), and patient's usual exercise activity is important because these variables can be the focus for intervention strategies to prevent early deterioration in dialysis patients' functional health status.

Adult↗

An HIV self-care symptom management intervention for African American mothers.

BACKGROUND: Human immunodeficiency virus (HIV) infection has become a serious health problem for low-income African American women in their childbearing years. Interventions that help them cope with feelings about having HIV and increase their understanding of HIV as a chronic disease in which self-care practices, regular health visits, and medications can improve the quality of life can lead to better health outcomes. OBJECTIVE: This study aimed to determine the efficacy of an HIV self-care symptom management intervention for emotional distress and perceptions of health among low-income African American mothers with HIV. METHOD: Women caregivers of young children were randomly assigned to self-care symptom management intervention or usual care. The intervention, based on a conceptual model related to HIV in African American women, involved six home visits by registered nurses. A baseline pretest and two posttests were conducted with the mothers in both groups. Emotional distress was assessed as depressive symptoms, affective state, stigma, and worry about HIV. Health, self-reported by the mothers, included the number of infections and aspects of health-related quality of life (i.e., perception of health, physical function, energy, health distress, and role function). RESULTS: Regarding emotional distress, the mothers in the experimental group reported fewer feelings of stigma than the mothers in the control group. Outcome assessments of health indicated that the mothers in the experimental group reported higher physical function scores than the control mothers. Within group analysis over time showed a reduction in negative affective state (depression/dejection and tension/anxiety) and stigma as well as infections in the intervention group mothers, whereas a decline in physical and role function was found in the control group. CONCLUSIONS: The HIV symptom management intervention has potential as a case management or clinical intervention model for use by public health nurses visiting the home or by advanced practice nurses who see HIV-infected women in primary care or specialty clinics.

Adult↗

Health-related quality of life in Persian Gulf War Veterans.

OBJECTIVE: The objective of this investigation is to describe the health-related quality of life of Persian Gulf War (GW) veterans and to examine the effects of current chronic medical conditions and psychiatric status on physical functioning. METHODS: To measure health-related quality of life, the Medical Outcomes Short Form Survey (SF36) was administered approximately 4 years after the GW to a stratified, random sample of New England-area GW-deployed veterans and a group of military personnel deployed to Germany during the GW. The SF36 scores for the GW-deployed study population (N = 141) were compared with those for the Germany-deployed group (N = 46) and with published U.S. population norms. Multiple linear regression analyses were performed to identify risk factors associated with lower physical health functioning in the GW-deployed study group. RESULTS: Functional health status was significantly lower in the GW-deployed group compared with the Germany-deployed group for each of the SF36 subscales and the two summary scores (Physical Component Summary [PCS] and Mental Component Summary). Compared with the general U.S. population, the GW-deployed group median was between the 25th and 50th percentile for the Physical Functioning subscale and the PCS score. Within the GW-deployed group, lower education, psychological symptomatology, and a higher number of chronic self-reported medical conditions were significant predictors of the PCS score. CONCLUSION: GW-deployed veterans report lower functional health status compared with a group of Germany-deployed veterans and published general U.S. population norms. Within the group of GW-deployed veterans, several current medical and psychological conditions predictive of lower physical functioning levels were identified.

Adult↗

Functional health and well-being of relatively young women with peripheral arterial disease is decreased but stable after diagnosis.

OBJECTIVE: This study was undertaken to investigate the extent to which health-related quality of life (HQOL) is reduced in young women with peripheral arterial disease (PAD) compared with age-matched and gender-matched control subjects. Moreover, potential determinants of HQOL in young women with PAD were studied, ie, traditional cardiovascular risk factors, location of stenosis and time since diagnosis. METHODS: This was a population-based case-control study. Subjects were 208 young (<50 years) women with PAD diagnosed at angiography and 471 population-based age-matched and gender-matched control subjects. All participants completed the RAND-36 questionnaire, which produces a HQOL profile. The questionnaire contains 36 items that assess 8 domains of HQOL. Each domain is given a mean score ranging from 0 to 100, with higher scores indicative of better quality of life. RESULTS: PAD had a deleterious effect on HQOL in young women. Ability to deal with the physical requirements of daily life was affected, and physical capabilities limited activity to a considerable extent. Mean differences observed for 2 domains, ie, Physical functioning and Role-physical, were -25.1 (95% confidence interval [CI], -28.8,-21.4) and -22.5 (95% CI, -28.9,-16.0). Within the group of young women with PAD, HQOL did not depend on age, smoking, hypercholesterolemia, or education. However, women with hyperglycemia, hypertension, or increased body mass index scored lower on 1 or more domains of RAND-36. Location of stenosis was also related to HQOL; patients with more proximal stenosis scored slightly higher on the domain Physical functioning, compared with women with more distal stenosis. Time (0-10 years) between diagnosis (1990-1999) and when RAND-36 was filled out (2000) is related to score on the Mental health domain; score increases over time. Scores on the other 7 domains of HQOL showed no significant relation to duration of disease. CONCLUSION: Quality of life in young women with PAD was statistically significant diminished for all domains of RAND-36 in comparison with HQOL in healthy age-matched control subjects. HQOL of patients with recently diagnosed PAD is comparable to that of patients in whom the diagnosis was made several years previously. Effective therapy might stabilize, albeit not improve, quality of life in this specific patient population.

Adult↗

Contributions of physical and sexual abuse to women's experiences with chronic pelvic pain.

OBJECTIVE: To examine the roles of physical and sexual abuse in women with chronic pelvic pain using multi-dimensional pain assessment and to compare the chronic pelvic pain experiences of women with physical abuse to those of women with sexual abuse. STUDY DESIGN: Structured questionnaires were used to measure self-reported abuse, pain severity, psychological distress, physical functioning, interpersonalfunctioning, and coping in 63 women attending a tertiary care gynecologic clinic for diagnosis and treatment of chronic pelvic pain. RESULTS: Women with chronic pelvic pain who reported abuse demonstrated significantly more psychological distress than did women who reported no abuse, but there were no differences in pain severity, physical functioning, interpersonal functioning or coping. Women with physical abuse reported more overall psychological distress, depression, anxiety and somatization than women who reported no physical abuse. Women who reported sexual abuse showed more overall psychological distress and anxiety than women who reported no sexual abuse. While physical abuse was more consistently associated with psychological distress than was sexual abuse, both types of abuse were risk factors for distress. CONCLUSION: These results suggest that both physical and sexual abuse are associated with psychological distress in women with chronic pelvic pain but not with other domains of pain experience. Additional research to improve identification and treatment of women with both chronic pelvic pain and abuse is indicated.

Adult↗

Health-related quality of life among renal-transplant recipients in Japan.

BACKGROUND: This study had four goals: (1) to evaluate an index of health-related quality of life (HQOL) among renal-transplant recipients in Japan, (2) to compare HQOL of renal-transplant recipients with that of the Japanese population as a whole, and (3,4) to study associations of HQOL with renal function and with the time since transplantation. METHODS: Questionnaires were distributed to 570 subjects. All were outpatients, were 16 years old or older, and were studied at least 1 year after they had received their latest renal transplant. HQOL was assessed with the Short Form 36-item health survey. Subjects' physicians provided data on renal function. Associations of HQOL with serum creatinine concentration and with the time since transplantation were evaluated by logistic regression. RESULTS: The response rate was 83%. Data from patients with diabetes and from those who had had at least two renal transplants were excluded; data from 395 recipients were analyzed. On the physical functioning, general health perception, vitality, and social functioning scales, the patients' scores were significantly lower than the Japanese national-norm scores. General health perception was particularly low. Serum creatinine concentrations were associated with general health perception, vitality, and social functioning. Longer times since transplantation were associated with better social functioning. CONCLUSIONS: Although social and physical functioning may improve after transplant surgery, a low self-rating of general health seemed to remain. The rarity of renal transplantation in Japan and other psychosocial factors may explain the low self-rating of general health in Japanese renal-transplant recipients.

Adolescent↗