Background and Purpose: The purpose of this study was to analyze recovery of motor function in a cohort of patients presenting with an acute occlusion in the carotid distribution. Analysis of recovery patterns is important for estimating patient care needs, establishing therapeutic plans, and estimating sample sizes for clinical intervention trials.Methods: We prospectively measured the motor deficits of 104 stroke patients over a 6-month period to identify earliest measures that would predict subsequent motor recovery. Motor function was measured with the Fugl-Meyer Assessment. Fifty-four patients were randomly assigned to a training set for model development; SO patients were assigned to a test set for model validation. In a second analysis, patients were stratified on basis of time and stroke severity. The sample size required to detect a 50% improvement in residual motor function was calculated for each level of impairment and at three points in time.Results: At baseline the initial Fugl-Meyer motor scores accounted for only half the variance in 6-month motor function (r
Parathyroidectomy is the definitive therapy for patients with symptomatic primary hyperparathyroidism. However, the role of surgery in mild asymptomatic primary hyperparathyroidism remains controversial. Accordingly, we conducted a prospective, randomized, controlled clinical trial of parathyroidectomy to determine the benefits of surgery vs. adverse effects of no surgery. Fifty-three patients were randomly assigned to either parathyroidectomy (n = 25) or regular follow-up (n = 28). Bone mineral density (BMD), biochemical indices of the disease, quality of life, and psychological function were measured at 6- or 12-month intervals for at least 24 months. Twenty-three of the 25 patients randomized to parathyroidectomy had surgery within the specified time of the protocol and three of the 28 patients randomized to regular follow-up had parathyroidectomy during follow-up. After parathyroidectomy, there was an increase in BMD of the spine (1.2%/yr, P < 0.001), femoral neck (0.4%/yr, P = 0.031), total hip (0.3%/yr, P = 0.07), and forearm (0.4%/yr, P < 0.001) and an expected fall in serum total and ionized calcium, serum PTH, and urine calcium (P < 0.001 for all). In contrast, patients followed up without surgery lost BMD at the femoral neck (-0.4%/yr, P = 0.117) and total hip (-0.6%/yr, P = 0.007) but gained at the spine (0.5%/yr; P = ns) and forearm (0.2%/yr, P = 0.047), with no significant changes in biochemical indices of disease. Consequently, a significant effect of parathyroidectomy on BMD was evident only at the femoral neck (a group difference of 0.8%/yr; P = 0.01) and total hip (a group difference of 1.0%/yr; P = 0.001) but not at the spine (a group difference of 0.6%/yr) or forearm (a group difference of 0.2%/yr). Quality-of-life scores as measured by a 36-item short-form health survey showed significant declines in five of the nine domains (social functioning, physical problem, emotional problem, energy, and health perception) in patients followed up without surgery but in only one of the nine domains (physical function) in the patients who had parathyroidectomy. Consequently, a modest measurable benefit of parathyroidectomy was evident in social and emotional role function (P = 0.007 and 0.012, respectively). Psychological function as assessed by the symptom checklist revised did not change significantly in either group, except for a significant decline in anxiety (P = 0.003) and phobia (P = 0.024) in patients who had surgery in comparison with those who did not. We conclude that it is feasible to conduct a randomized, controlled clinical trial of parathyroidectomy in patients with mild asymptomatic primary hyperparathyroidism, and measurable benefits of surgery on BMD, quality of life, and psychological function can be demonstrated. However, the small but significant benefits of parathyroidectomy must be weighed against the risks of surgery in these otherwise healthy individuals.
OBJECTIVE -Although poor medication adherence may contribute to inadequate diabetes control, ways to feasibly measure adherence in routine clinical practice have yet to be established. The present study was conducted to determine whether pharmacy claims-based measures of medication adherence are associated with clinical outcomes in patients with diabetes.RESEARCH DESIGN AND METHODS -The study setting was a large, integrated delivery and financial system serving the residents of southeastern Michigan. The study population consisted of 677 randomly selected patients aged Ն18 years with a diagnosis of diabetes, hypercholesterolemia, and hypertension and who filled at least one prescription for either an antidiabetic, lipid-lowering, or antihypertensive drug in each of the 3 study years (1999 -2001). The main outcome measures were HbA 1c , LDL cholesterol levels, and blood pressure.RESULTS -Nonadherent patients had both statistically and clinically worse outcomes than adherent patients. Even after adjusting for demographic and clinical characteristics, nonadherence was significantly associated with HbA 1c and LDL cholesterol levels. A 10% increase in nonadherence to metformin and statins was associated with an increase of 0.14% in HbA 1c and an increase of 4.9 mg/dl in LDL cholesterol levels. Nonadherence to ACE inhibitors was not significantly associated with blood pressure.CONCLUSIONS -Claims-based measures of medication adherence are associated with clinical outcomes in patients with diabetes and may therefore prove to be useful in clinical practice. More research is needed on methods to introduce claims-based adherence measurements into routine clinical practice and how to use these measurements to effectively improve adherence and health outcomes in chronic care management. Diabetes Care 27:2800 -2805, 2004N onadherence to medications is a common problem in clinical practice, especially among patients with asymptomatic chronic conditions such as diabetes, hypertension, and hypercholesterolemia (1-4). A recent meta-analysis has showed that the average adherence in patients with diabetes is 67.5%, which is lower than that found among many conditions (5). Also, recently, a specific systematic review on adherence to medications for diabetes showed that average adherence to oral hypoglycemic agents ranged from 36 to 93% (6). In general, poor adherence to medications has been shown to be associated with the development of complications, disease progression, avoidable hospitalizations, premature disability, and death. In total, the costs associated with poor medication adherence are estimated to approach $100 billion per year (7). Despite these known consequences, adherence rates have remained unchanged since the 1970s (1,8).Nonadherence is the result of a complex interaction among the social environment, the patient, and the health providers (9). Adherence to medications is not routinely measured in clinical practice, and a gold standard that can be easily implemented, even for research purposes, does not exist (1,5,...
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