The effect of alendronate on fracture-related healthcare utilization and costs: the fracture intervention trial.

The Vertebral Fracture Arm (VFA) of the Fracture Intervention Trial (FIT) study demonstrated that alendronate reduced the incidence of spine, forearm and hip fractures in women with low bone mass and existing vertebral fractures by about 50%. The objective of the present study was to determine the effects of alendronate therapy versus placebo on fracture-related healthcare utilization and costs. Participants were randomly assigned to double-masked treatment with alendronate (5 mg/day for 2 years and then 10 mg/day for 1 year) or placebo for 3 years. For each patient experiencing a clinical fracture, we determined whether treatment in an emergency room, hospital, nursing home and/or rehabilitation hospital was a consequence of the fracture. The VFA of the FIT Study enrolled 2027 women aged 55-81 years with low bone mass and pre-existing vertebral fractures from population-based listings in 11 metropolitan areas of the United States. We measured (1) the proportion of patients who had any fracture-related healthcare event and (2) the estimated cost of fracture-related healthcare services. Alendronate significantly reduced the proportion of patients utilizing fracture-related healthcare (emergency room, hospital, rehabilitation hospital or nursing home) by 25% (p = 0.038). Alendronate significantly reduced the costs associated with hip-fracture-related care by 58%, or $181 per patient randomized (p = 0.036). The reduction in fracture-related total costs was 35% ($190 per patient randomized) in the alendronate group relative to the placebo group (p = 0.114). Alendronate thus not only reduces the incidence of clinical fractures and associated morbidity, but reduces the proportion of patients utilizing the associated healthcare resources.

Economic and health-related quality of life considerations of new therapies in Parkinson's disease.

The progressive disability of Parkinson's disease results in substantial burdens for patients, their families and society in terms of increased health resource use, poorer quality of life, caregiver burden, disrupted family relationships, decreases in social and leisure activities, deteriorating emotional well-being, and direct and indirect costs of illness. Health-related quality of life (HR-QOL) measures have been used successfully in cross-sectional studies to identify and characterise these burdens; however, there is not yet substantial evidence that these instruments will be responsive to changes in patients over time and that the results will provide patients and health professionals with clinically meaningful information useful in making decisions about treatment strategies. The few studies documenting direct and indirect costs indicate increased use of ancillary health and community services, significant adaptations in home and transportation, increased use of mobility and self-care aids, and lack of access to appropriate healthcare providers. Patients with Parkinson's disease incur higher hospital expenses, have increased number of prescriptions, and experience earnings loss; the latter also applies to family caregivers. The choice, intensity and timing of therapy are determined by a variety of factors: presenting symptoms, age, employment status, comorbidity, cognitive impairment and level of functional impairment. Choices must be individually tailored to a patient's physical and personal needs. To be useful for patients with Parkinson's disease in clinical practice, clinicians should be able to use HR-QOL measures to identify appropriate medical interventions or socio-behavioural modifications to modify the HR-QOL deficits. However, while the interplay of interventions and clinical outcomes are often well understood, the effects of interventions on HR-QOL outcomes have not been studied extensively. Little research has been done that explicitly links the signs and symptoms of Parkinson's disease to the HR-QOL outcomes. The only Parkinson's disease cost-effectiveness study as yet performed indicated higher costs for patients receiving pramipexole than for those not taking the drug, but additional quality life-years were gained. Longer term effectiveness of many treatment strategies, and the usefulness of HR-QOL instruments to assess these treatments for individual patients over time, are critical areas for future research.

Illness episodes and cortisol in healthy older adults during a life transition.

Alterations in neuroendocrine functioning and in the neuroendocrine response to stress have been observed in older adults. Stressful life events have also been associated with increased illness vulnerability. However effects of natural life stressors on neuroendocrine functioning and health of the elderly have not been well characterized. This research examines relationships among cortisol, dehydroepiandrosterone sulfate (DHEA-S), distress, and illness episodes in an elderly population experiencing the life transition of housing relocation. Thirty older adults moving to congregate livingfacilities were assessed in their homes 1 month premove and 2 weeks postmove. Twenty-eight nonmoving comparison participants were assessed at similar time points. Assessments included measures of intrusion, cortisol, DHEA-S, and self-reported infectious illness episodes. Movers reported more illness episodes between the two assessments than controls. Significant alterations in neuroendocrine measures were not observed among movers at either time point. Individuals with more intrusive thoughts had higher cortisol levels concurrently and prospectively, but these relationships did not vary by group. Greater intrusion at premove was associated with a greater likelihood of reported illness episodes between the two assessments, but there were no relationships between neuroendocrine factors and illness episodes, and intrusion did not mediate the relationships between group and likelihood of illness. In healthy elders, a temporary life stressor may increase vulnerability to illness but does not

Estimation of the average correlation coefficient for stratified bivariate data.

If the relationship between two ordered categorical variables X and Y is influenced by a third categorical variable with K levels, the Cochran-Mantel-Haenszel (CMH) correlation statistic QC is a useful stratum-adjusted summary statistic for testing the null hypothesis of no association between X and Y. Although motivated by and developed for the case of K I x J contingency tables, the correlation statistic QC is also applicable when X and Y are continuous variables. In this paper we derive a corresponding estimator of the average correlation coefficient for K I x J tables. We also study two estimates of the variance of the average correlation coefficient. The first is a restricted variance based on the variances of the observed cell frequencies under the null hypothesis of no association. The second is an unrestricted variance based on an asymptotic variance derived by Brown and Benedetti. The estimator of the average correlation coefficient works well in tables with balanced and unbalanced margins, for equal and unequal stratum-specific sample sizes, when correlation coefficients are constant over strata, and when correlation coefficients vary across strata. When the correlation coefficients are zero, close to zero, or the cell frequencies are small, the confidence intervals based on the restricted variance are preferred. For larger correlations and larger cell frequencies, the unrestricted confidence intervals give superior performance. We also apply the CMH statistic and proposed estimators to continuous non-normal data sampled from bivariate gamma distributions. We compare our methods to statistics for data sampled from normal distributions. The size and power of the CMH and normal theory statistics are comparable. When the stratum-specific sample sizes are small and the distributions are skewed, the proposed estimator is superior to the normal theory estimator. When the correlation coefficient is zero or close to zero, the restricted confidence intervals provide the best performance. None of the confidence intervals studied provides acceptable performances across all correlation coefficients, sample sizes and non-normal distributions.

The usefulness of the Functional Status Questionnaire and Medical Outcomes Study Short Form in Parkinson's disease research.

Parkinson's disease (PD) has no cure and is a progressive neurological disorder with treatment aimed at the maintenance of function and limitation of the symptoms. No extensive studies of the disease's impact on health-related quality of life (HRQoL) have been conducted. The purpose of this study was to assess the potential usefulness of the Medical Outcomes Study Short Form (SF-36) and the Functional Status Questionnaire (FSQ) in Parkinson's disease research. This cross-sectional study of 193 PD patients who visited two hospital-based neurology clinics used self-administered in-clinic and take-home questionnaires to ascertain the demographic and environmental characteristics of the subjects and to gain health profile measures from the SF-36 and the FSQ. The two health profiles provide important HRQoL information supplementary to the traditional signs and symptoms evaluated by the Unified Parkinson's Disease Rating Scale (UPDRS). Many of the HRQoL measures discriminate progressive stages of disease in this study group and distinguish those with complications of therapy from subjects without complications.

The health burdens of Parkinson's disease.

Parkinson's disease (PD) is likely to have a substantial impact on an individual's health-related quality of life (HRQL), health-related resource use, and productivity. Data about the health burdens of PD by disease stage are fundamental to understanding the effectiveness of care, both from a clinical and a fiscal point of view. This study's goal was to describe the associations of patient-reported HRQL and economic characteristics with PD stage. We hypothesized that later stages of PD would be associated with poorer HRQL, greater health-related resource use, and lower work productivity than early stages of PD. We used a cross-sectional analysis to study 193 PD patients attending two hospital-based neurology clinics. Self-administered questionnaires and in-person interviews measured clinical features, functional status, general health perceptions, well-being, overall HRQL, work productivity, and health-related resource use. Consistent, strong associations were found between stage and functional status, general health perceptions, well-being, and overall HRQL even after controlling for age, gender, and comorbid conditions. Most resource use and work productivity measures were also associated with disease stage. However, physician services use was not. This study confirms that the burdens of illness are progressively higher for PD patients with early, moderate, and advanced illness. The results suggest that such important facets of the health burden as HRQL and health-related resource use may be seriously misjudged if not carefully measured but inferred from clinical observations alone.

Physical activity, physical function, and the risk of breast cancer in a prospective study among elderly women.

BACKGROUND: Accumulating evidence suggests that physical activity may protect against the development of breast cancer, but less is known about the role of modest physical activity during the postmenopausal years and in the context of physical function. METHODS: We evaluated this association in the Iowa 65+ Rural Health Study, a population-based, prospective cohort study of elderly adults. The cohort was linked to a population-based cancer registry for the years 1973-93, and the at-risk cohort consisted of 1806 women ages 65 to 102 years with an in-person baseline interview in 1982 and with no documented cancer between 1973 and the baseline interview. Through 1993 (16,857 person-years of follow-up) there were 46 incident cases of breast cancer. RESULTS: Greater level of physical activity in women with no physical disabilities was inversely associated with breast cancer risk (p for trend = .01). Compared to inactive women with no physical disability, women reporting moderate (age-adjusted relative risk [RR] = 0.5, 95% confidence interval [CI] 0.3-1.1) or high (age-adjusted RR = 0.2, 95% CI .05-0.9) activity levels were at decreased risk of breast cancer. Women with any disability were also at decreased risk of breast cancer compared to inactive women with no disability (age-adjusted RR = 0.4; 95% CI 0.2-0.9). Adjustment for education, body mass index, age at menarche, age at menopause, previous use of hormone replacement therapy, pregnancy history, systolic blood pressure, smoking, and alcohol use did not alter these associations. In addition, these associations were similar after exclusion of cases occurring during the first two years of follow-up, after adjusting for the number of doctor visits, and after stratifying by stage at diagnosis. CONCLUSIONS: These data suggest that postmenopausal activity level, after accounting for physical disability, is inversely associated with breast cancer risk.

The impact of Parkinson's disease on health status, health expenditures, and productivity. Estimates from the National Medical Expenditure Survey.

Parkinson's disease (PD) is a common disorder that leads to severe disability, despite pharmacological and surgical interventions. As PD progresses, patients and their families experience substantial health and economic burdens. Little research has been conducted into the economic consequences of PD or the impairment of health dimensions, such as social function and mental health, that may accompany the deterioration in economic resources and physical function. In the current study, the US National Medical Expenditure Survey (NMES) was examined as a source of population-based information about health-resource use, medical expenditures and health status. 43 patients with PD were identified, and each was matched with 3 individuals without PD to estimate the costs attributable to PD. Data from the NMES demonstrate the serious health and economic burdens of PD. The patients with PD were clearly shown to have decreased health status, increased health expenditures and lost productivity relative to controls. However, these estimates of the magnitude of disease burden must be used with caution. The small sample size appears to have inadequately represented patients in the earliest and the most advanced stages of PD. There was also considerable variability in case-control groups, resulting in wide confidence intervals for the estimates.

Association of smoking, body mass, and physical activity with risk of prostate cancer in the Iowa 65+ Rural Health Study (United States).

Smoking, obesity, alcohol, and physical activity can modulate the endocrine system, and therefore have been hypothesized to play a role in the etiology of prostate cancer. At baseline in 1982, 80 percent (n = 3,673) of the noninstitutionalized persons age 65+ in two rural Iowa (United States) counties were enrolled into the Iowa 65+ Rural Health Study. Follow-up for mortality was complete through 1993, and cancer experience was determined by linkage to the State Health Registry of Iowa cancer database for the years 1973-93. We analyzed data on 1,050 men aged 65 to 101 years (mean age 73.5) with a full interview in 1982 and with no documented cancer in the 10 years prior to baseline. Through 1993 (8,474 person-years of follow-up), there were 71 incident cases of prostate cancer. In a multivariate model, age, cigarette smoking (relative risk [RR] = 2.9 for currently smoking 20 or more cigarettes per day compared with never smoking; P trend = 0.009), greater body mass index (BMI) (wt/ht2) (RR = 1.7 for BMI > 27.8 kg/m2 compared with < 23.6; P trend = 0.1), and greater level of physical activity (RR = 1.9 for high activity level cf inactive; P trend = 0.05) were independent predictors of prostate cancer, and these associations were stronger for regional or disseminated disease at diagnosis. Percent change in BMI from age 50 to baseline was associated positively with risk (P trend = 0.01), and this association appeared to be stronger in heavier men. There were no data on diet. These findings suggest that smoking, overweight, and weight gain in later life are risk factors for prostate cancer and support a hormonal etiology; the positive association for physical activity confirms some previous reports, but remains without a credible biologic mechanism.

Nonsteroidal antiinflammatory drugs and cognitive decline in the elderly.

OBJECTIVE: To better define the role of nonsteroidal antiinflammatory drugs (NSAID) in cognitive decline of the elderly. METHODS: Population based inception cohort of the rural elderly. NSAID user status was characterized as high dose, low/medium dose, or nonuser at 2 successive in-person interviews 3 years apart (F3 and F6). Respondents were from the Iowa 65+ Rural Health Study, one of the 4 cohorts of the National Institute on Aging's Established Populations for Epidemiologic Studies of the Elderly. Memory decline was assessed by a change in immediate word recall between F3 and F6. Multivariable logistic regression models were created to determine important predictors of the F3 to F6 recall memory decline in groups with poor, average, and good word recall at the F3 interview. Specific NSAID were compared to assess which drugs, if any, were associated with memory decline. RESULTS: The 2 factors most strongly associated with a significant immediate word recall decline between F3 and F6 among individuals in the average F3 word recall group were limitation in functional status [odds ratio (OR) = 2.31, 95% Confidence Interval (CI) (1.51, 3.52)] and high dose NSAID use [OR = 2.04, 95% CI (1.07, 3.89)]. No single NSAID agent was significantly more strongly associated with word recall decline than the others. However, in exploratory analyses use of high dose NSAID of the proprionic acid family neared significance for recall decline [OR = 3.17, 95% CI (0.92, 10.9). CONCLUSION: In elderly respondents with average baseline recall memory, high dose NSAID were a significant risk factor for longitudinal memory decline in this community based cohort. Although a large scale clinical trial is needed to definitely address this issue, we provide further evidence that NSAID play a role in cognitive dysfunction in the elderly.