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1.  Patterns of non-adherence to antihypertensive therapy in primary care 
Non-adherence to medications is an important cause of poor blood pressure control. Long-acting antihypertensives (LAs) could theoretically be beneficial in partially adherent patients, who are common in contemporary practice. Little has been reported about the duration of drug holidays (DHs) in treated hypertensives outside of generally compliant subjects in phase 4 clinical trials. We described patterns of non-adherence to single and multiple antihypertensives in a random sample of 120 primary care patients with uncontrolled hypertension. Adherence to up to three antihypertensives was measured by electronic monitoring. We calculated frequencies of single day omissions and DHs of two consecutive days (DH2), three days (DH3) or four days or more (DH≥4) for each drug. Overall, 89 (74%) of patients had at least a one-day omission. A single day omission was found in 61.4% of the patients on one drug, followed by DH≥4 (28.1%), DH2 (26.3%) and DH3 (8.8%). In patients using multiple drugs, single day omissions were also most common, followed by DH≥4, DH2 and DH3. Omissions of three or fewer days comprise on average 74 % of all omissions. Although encouraging full adherence remains important, it may be prudent to prescribe LAs which can compensate for the majority of dose omissions.
PMCID: PMC3711402  PMID: 23339728
Hypertension; medication adherence; drug holidays; electronic monitoring
2.  Conceptual Challenges and Practical Approaches to Screening Capacity for Self-care and Protection in Vulnerable Older Adults 
Identifying impairments in the capacity to make and execute decisions is critical to the assessment and remediation of elder self-neglect. Few capacity assessment tools are available for use outside of health care settings and none have been validated in the context of elder self-neglect. Health and social services professionals are in need of validated tools to assess capacity for self-care and self protection during initial evaluations of older adults with suspected self-neglect syndrome. Currently, legal and medical declarations of incapacity and guardianship rely on clinical evaluations and instruments developed to assess only decision-making capacity. This paper first describes the conceptual and methodological challenges to assessing the capacity to make and execute decisions regarding safe and independent living. Second, the paper describes the pragmatic obstacles to developing a screening tool for the capacity for self-care and self protection (SC&P). Finally, the paper outlines the process for validation and field testing of the screening tool. A valid and feasible screening tool can then be used during field assessments by social services professionals to screen for potential impairments in the capacity for self-care and protection in vulnerable older adults.
PMCID: PMC3717403  PMID: 19016970
self-neglect syndrome; elder abuse and neglect; capacity; decision making
3.  Effect of a Physician Uncertainty Reduction Intervention on Blood Pressure in Uncontrolled Hypertensives—A Cluster Randomized Trial 
Clinical inertia, provider failure to appropriately intensify treatment, is a major contributor to uncontrolled blood pressure (BP). Some clinical inertia may result from physician uncertainty over the patient’s usual BP, adherence, or value of continuing efforts to control BP through lifestyle changes.
To test the hypothesis that providing physicians with uncertainty reduction tools, including 24-h ambulatory BP monitoring, electronic bottle cap monitoring, and lifestyle assessment and counseling, will lead to improved BP control.
Cluster randomized trial with five intervention clinics (IC) and five usual care clinics (UCC).
Six public and 4 private primary care clinics.
A total of 665 patients (63 percent African American) with uncontrolled hypertension (BP ≥140 mmHg/90 mmHg or ≥130/80 mmHg if diabetic).
An order form for uncertainty reduction tools was placed in the IC participants’ charts before each visit and results fed back to the provider.
Percent with controlled BP at last visit. Secondary outcome was BP changes from baseline.
Median follow-up time was 24 months. IC physicians intensified treatment in 81% of IC patients compared to 67% in UCC (p < 0.001); 35.0% of IC patients and 31.9% of UCC patients achieved control at the last recorded visit (p > 0.05). Multi-level mixed effects longitudinal regression modeling of SBP and DBP indicated a significant, non-linear slope difference favoring IC (p time × group interaction = 0.048 for SBP and p = 0.001 for DBP). The model-predicted difference attributable to intervention was −2.8 mmHg for both SBP and DBP by month 24, and −6.5 mmHg for both SBP and DBP by month 36.
The uncertainty reduction intervention did not achieve the pre-specified dichotomous outcome, but led to lower measured BP in IC patients.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-011-1888-1) contains supplementary material, which is available to authorized users.
PMCID: PMC3304039  PMID: 22033742
hypertension control; cluster randomized trial; physician uncertainty
4.  Factors that influence survival in a probable Alzheimer disease cohort 
This longitudinal study examined multiple factors that influence survival in a cohort of Alzheimer patients followed over two decades.
Time to death after symptom onset was determined in 641 probable AD patients who were evaluated annually until death or loss to follow-up, and information was entered into a longitudinal database. Date of death was available for everyone including those eventually lost. Baseline variables included age, sex, race, disease severity, a calculated index of rate of initial cognitive decline from symptom onset to cohort entry (pre-progression rate or PPR), years of education, and medical comorbidities (diabetes, hypertension, hyperlipidemia, coronary disease, cerebrovascular disease). Multivariable Cox proportional hazard regression analysis was used to analyze the baseline and/or time dependent association in Mini-mental Status Exam (MMSE) severity, Physical Self Maintenance Scale (PSMS), Persistency Index (PI) of exposure to antipsychotic and antidementia drugs, and psychotic symptoms (hallucinations, delusions) with mortality.
Baseline covariates significantly associated with increased survival were younger age (p = .0016), female sex (p = .0001), and a slower PPR (p < .0001). Overall disease severity at baseline, medical comorbidities, and education did not influence time to death. Time-dependent changes in antipsychotic drug use, development of psychotic symptoms, antidementia drug use, and observed MMSE change were not predictive. In the final model the only time-dependent covariate that significantly decreased survival was worsening of functional ability on the PSMS (hazard ratio = 1.10; CI: 1.07-1.11).
In this large AD cohort survival is influenced by age, sex, and the development of functional disability during follow-up. The most important predictor of mortality was a faster rate of cognitive decline at the initial patient visit (PPR). The currently available antidementia drugs do not prolong survival in Alzheimer patients.
PMCID: PMC3506931  PMID: 22594761
5.  Progress in understanding variability in cognitive responses to cholinesterase inhibitor treatment 
Limitations on the duration of clinical trials, and the constraints of participant selection for such studies, have left many unanswered questions regarding the optimal duration of drug treatment for Alzheimer's disease patients, as well as the subgroups of patients that benefit most. Carefully designed observational studies in naturalistic settings can provide important supplementary information to aid clinical decision-making and patient counseling. A paper by Wattmo and colleagues published recently in Alzheimer's Research & Therapy has provided important new information on differential responses to cholinesterase inhibitor (ChEI) treatment in specific subgroups of patients over a 3-year follow-up period. All of the participants in their study were started on one of three ChEIs after their initial assessment, and periodic assessments of cognitive change and the dosage of ChEIs as well as concomitant medications were subsequently recorded. In addition to providing strong evidence of nondifferential effects on cognition of the three ChEIs as used in this practice, the study identified clinically significant differences in the responses of specific subgroups of patients to the initiation of ChEI treatment. Of particular interest to clinicians is the finding that older patients and those with worse cognitive functioning at baseline had a better treatment response. The notion that treatment may be futile in the oldest or the most impaired patients was thus not supported by Wattmo and colleagues' cohort. Additional well-designed naturalistic studies of this type are needed to advance our knowledge of the long-term outcomes obtained with different therapeutic agents, and of the covariates that significantly modify responses to Alzheimer's disease treatments.
PMCID: PMC3218807  PMID: 21999183
6.  Vitamin E Use Is Associated with Improved Survival in an Alzheimer's Disease Cohort 
Vitamin E at a dose of 2,000 IU per day has been shown to delay Alzheimer's disease (AD) progression, but recent studies have questioned the safety of this dose level and the overall efficacy of vitamin E in AD treatment.
We analyzed the survival history of 847 probable or mixed AD patients followed in a research center between 1990 and the censoring date of December 31, 2004. Standard practice during this period was to recommend vitamin E at 1,000 IU twice daily to all patients. We used Cox proportional hazards modeling to assess the association of vitamin E alone, or in combination with a cholinesterase inhibitor (ChEI), with all-cause mortality, adjusting for important covariates. Approximately two thirds of the patients took vitamin E with a ChEI, 10% took vitamin E alone, and 15% took no antidementia drug.
The adjusted hazard ratio (HR) associated with vitamin E (with or without a ChEI) was 0.71 (95% CI: 0.57–0.89; p = 0.003). Compared to the no drug treatment group, the HR for vitamin E alone or with another drug was 0.77 (95% CI: 0.60–1.0); the HR for ChEI use alone was 1.2 (95% CI: 0.87–1.60).
The results do not support a concern over increased mortality with high-dose vitamin E supplementation.
PMCID: PMC2866579  PMID: 20016184
Alzheimer's disease; Survival; Vitamin E
7.  Does Reducing Physician Uncertainty Improve Hypertension Control? Rationale and Methods 
Hypertension affects nearly one-third of the U.S. population overall, and the prevalence rises sharply with age. In spite of public educational campaigns and professional education programs to encourage blood pressure measurement and control of both systolic and diastolic control to < 140/90 mmHg (or 130/80 mmHg if diabetic), 43% of treated hypertensives do not achieve the recommended JNC VII target. Among African-Americans, 48% are uncontrolled on treatment. The majority of persons classified as poorly controlled hypertensives have mild systolic blood pressure elevation (in the range of 140–160 mmHg). We hypothesized that physician uncertainty regarding the patient’s usual blood pressure, as well as uncertainty regarding the extent of medication non-adherence represent an important barrier to further reductions in the proportion of uncontrolled hypertensives in the U.S.
Using cluster randomization, ten primary care clinics (six from a public health care system and four from a private clinic system) were randomized to either the uncertainty reduction intervention condition or to usual care. An average of 68 patients per clinic were recruited to serve as units of observation. Physicians in the five intervention clinics were provided with a specially designed study form that included a graph of recent blood pressure measurements in their study patients, a check box to indicate their assessment of the adequacy of the patient’s blood pressure control, and a menu of services they could order to aid in patient management. These menu options included: 24-hour ambulatory blood pressure monitoring (ABPM); electronic bottle cap assessment of medication adherence, followed by medication adherence counseling in patients found to be non-adherent; and lifestyle assessment and counseling followed by 24-hour ABPM. Physicians in the five usual practice clinics did not have access to these services, but were informed of which patients had been enrolled in the study. Substudies carried out to further characterize the study population and interpret intervention results included ABPM and electronic bottle cap monitoring in a random subsample of patients at baseline, and audio recording of patient-physician encounters after intervention implementation.
The primary study endpoint was defined as the proportion of patients with controlled blood pressure (BP < 140/90 mmHg or < 130/80 mmHg if diabetic). Secondary endpoints include actual measured clinic systolic and diastolic blood pressure, patient physician communication patterns, physician prescribing patient self-reported lifestyle and medication adherence, physician knowledge, attitude and beliefs regarding the utility of intervention tools to achieve blood pressure control, and the cost-effectiveness of the intervention. Six-hundred eighty patients have been randomized, and 675 remain in active follow-up after 1.5 years. Patient closeout will be complete in March of 2009. Analysis of the baseline data is in progress.
Office-based blood pressure measurement error and bias, as well as physician and patient beliefs about the need for treatment intensification may be important factors that limit further progress in blood pressure control. This trial will provide data on the extent to which available technologies not widely used in primary care will change physician prescribing behavior and patient adherence to prescribed treatment.
PMCID: PMC2780342  PMID: 20031846
Hypertension Control; African-Americans; Cluster-randomized Trial; 24-hour Ambulatory Blood Pressure Monitoring; electronic bottle cap monitoring
8.  Adherence to diabetes self-care behaviors in English- and Spanish-speaking Hispanic men 
We conducted a qualitative study to elicit attitudes, attributions, and self-efficacy related to diabetes self-care in both English- and Spanish-speaking Hispanic men. Transcripts from six focus groups (three in English and three in Spanish) were reviewed by the authors to extract principal and secondary themes. Participants could describe their medication and lifestyle regimens and were aware of whether they were adherent or nonadherent to physician recommendations. Lack of skills on how to incorporate diet and regular physical activity into daily living, lack of will power, and reluctance to change culturally rooted behaviors emerged as significant barriers to diabetes self-management. Medication adherence is for some men the principal diabetes self-care behavior. Nonadherence appeared to fit two profiles: 1) intentional, and 2) nonintentional. In both instances low self-efficacy emerged as a significant influence on attainment and maintenance of diabetes self-care goals. Participants also expressed a strong sense of fatalism regarding the course of their disease, and seemed to have little motivation to attempt long-term dietary control. Educational and counseling messages should stress that a diagnosis of diabetes is not a death sentence, and full functional capacity can be maintained with good control.
PMCID: PMC2778413  PMID: 19936154
type 2 diabetes; self-care; glycemic control; adherence
9.  Persistent treatment with cholinesterase inhibitors and/or memantine slows clinical progression of Alzheimer disease 
There are no empiric data to support guidelines for duration of therapy with antidementia drugs. This study examined whether persistent use of antidementia drugs slows clinical progression of Alzheimer disease (AD) assessed by repeated measures on serial tests of cognition and function.
Six hundred forty-one probable AD patients were followed prospectively at an academic center over 20 years. Cumulative drug exposure was expressed as a persistency index (PI) reflecting total years of drug use divided by total years of disease symptoms. Baseline and annual testing consisted of Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Baylor Profound Mental Status Examination (BPMSE), Clinical Dementia Rating-Sum of Boxes (CDR-SB), Physical Self-Maintenance Scale (PSMS), and Instrumental Activities of Daily Living (IADL). Annual change in slope of neuropsychological and functional tests as predicted by follow-up time, PI, and the interaction of these two variables was evaluated.
PI was associated with significantly slower rates of decline (with, without adjustment for covariates) on MMSE (P < 0.0001), PSMS (P < 0.05), IADL (P < 0.0001), and CDR-SB (P < 0.001). There was an insignificant trend (P = 0.053) for the PI to be associated with slower rate of decline on BPMSE. The association of PI with ADAS-Cog followed a quadratic trend (P < 0.01). Analysis including both linear and quadratic terms suggests that PI slowed ADAS-Cog decline temporarily. The magnitude of the favorable effect of a rate change in PI was: MMSE 1 point per year, PSMS 0.4 points per year, IADL 1.4 points per year, and CDR-SB 0.6 points per year. The change in mean test scores is additive over the follow-up period (3 ± 1.94 years).
Persistent drug treatment had a positive impact on AD progression assessed by multiple cognitive, functional, and global outcome measures. The magnitude of the treatment effect was clinically significant. Positive treatment effects were even found in those with advanced disease.
PMCID: PMC2874259  PMID: 19845950

Results 1-9 (9)