PubMed · 10665979
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B Dan, G Cheron. 2000. Linking motor impairment to function.. https://doi.org/10.1017/s0012162200000104
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Patients in some randomized clinical trials may start additional non-randomized medication because of an exacerbation of symptoms or insufficient therapeutic effect. Typically this rescue medication reduces the observed treatment effect in intention-to-treat analysis. We discuss methods of analysis which take account of rescue medication in order to achieve a more meaningful comparison of the randomized treatments, focusing on trials with a repeated quantitative outcome. Ignoring all data after rescue is likely to be biased because rescued patients are a highly selected group. Instead we propose using methods based on ranks or multilevel models. The rank-based methods assume that rescued patients have especially bad underlying outcomes. The multilevel regression model relates a patient's outcome to allocated treatment and rescue status at each time, and requires correct modelling of all prognostic factors which predict starting rescue medication and of the covariance between outcomes measured at different times. We also describe sensitivity analyses over a range of possible models for the effect of rescue medication. We illustrate these methods in a trial in Parkinson's disease. It appears that adjustment for rescue medication will not radically alter the randomized treatment comparison unless rescue medication is substantially imbalanced between randomized groups and has a substantial effect on the outcome.
Parkinson's disease (PD) profoundly affects activities of daily living (ADL) and quality of human life. Although unilateral pallidotomy has become a common surgical treatment for persons with advanced PD, functional outcome data from previous reports have failed to uniformly support this procedure. In the present investigation, results from 12 studies meeting specific inclusion criteria were subjected to meta-analysis. Only reports featuring unilateral pallidotomy as the exclusive surgery, a sample size of at least five patients, explicit assessment of ADL, and sufficient quantitative data were subjected to analysis. Type of research design was not a factor in the selection process. The results of our analysis suggest that unilateral pallidotomy successfully enhances functional outcome in patients with clinically advanced PD.
OBJECTIVE: To examine risk factors for nursing home placement in a community-based dementia cohort. METHODS: Cognitively normal participants and cognitively impaired patients from a large AD Patient Registry were followed from diagnosis to placement, death, or last follow-up. This included over 3,600 person-years of surveillance. The normal group included 473 participants who did not, at any point, meet Diagnostic and Statistical Manual of Mental Disorders, 3rd ed., revised (DSM-III-R) criteria for dementia. The patient group included 512 patients who met DSM-III-R criteria for dementia or criteria for mild cognitive impairment at diagnosis. Demographic, medical, social, cognitive, behavioral, and functional predictors of time to placement were examined using Cox modeling. RESULTS: In the normal group, only 21 people (4%) required nursing home placement. With subjects, enrollment year, age at initial evaluation, being widowed, and living in a retirement community were associated with time to placement in separate univariate analyses. Of 512 cognitively impaired patients, 203 (39.6%) were placed in nursing homes. Median time from diagnosis to placement was 5.3 years. Within the patient sample, four predictors were determined to be associated with time to nursing home placement. These included gender, enrollment year, functional status, and cognitive score. Interactions were present for functional status with cognitive score and enrollment year. CONCLUSION: In patients with dementia who are within 5 years of diagnosis, placement rates of approximately 10% per year can be expected. Disease severity indices including degree of cognitive and functional impairment are primary risk factors for placement.