Identifying predictors of COVID-related delays in cancer-specific medical care.

PURPOSE: Evidence of the impact of the COVID-19 pandemic on cancer prevention and control is growing, but little is known about patient-level factors associated with delayed care. We analyzed data from a survey focused on Iowan cancer patients' COVID-19 experiences in the early part of the pandemic. METHODS: Participants were recruited from the University of Iowa Holden Comprehensive Cancer Center's Patients Enhancing Research Collaborations at Holden (PERCH) program. We surveyed respondents on demographic characteristics, COVID-19 experiences and reactions, and delays in any cancer-related health care appointment, or cancer-related treatment appointments. Two-sided significance tests assessed differences in COVID-19 experiences and reactions between those who experienced delays and those who did not. RESULTS: There were 780 respondents (26% response), with breast, prostate, kidney, skin, and colorectal cancers representing the majority of respondents. Delays in cancer care were reported by 29% of respondents. In multivariable-adjusted models, rural residents (OR 1.47; 95% CI 1.03, 2.11) and those experiencing feelings of isolation (OR 2.18; 95% CI 1.37, 3.47) were more likely to report any delay, where experiencing financial difficulties predicted delays in treatment appointments (OR 5.72; 95% CI 1.96, 16.67). Health insurance coverage and concern about the pandemic were not statistically significantly associated with delays. CONCLUSION: These findings may inform cancer care delivery during periods of instability when treatment may be disrupted by informing clinicians about concerns that patients have during the treatment process. Future research should assess whether delays in cancer care impact long-term cancer outcomes and whether delays exacerbate existing disparities in cancer outcomes.

Comparing COVID-19 Response Behaviors between a Cancer Patient Sample and a Population-Based Cancer-Free Sample in a Rural Midwestern State.

INTRODUCTION: The COVID-19 pandemic caused an increase in fear, anxiety, and depressive symptoms globally. For populations at increased risk for adverse outcomes due to illness, such as cancer patients, these worries may have been exacerbated. Understanding how the pandemic impacted cancer patients will inform better preparation for future events that cause disturbances to cancer care delivery. METHODS: This study analyzed data from two surveys to determine whether cancer patients' responses differed from a cancer-free population-based sample in terms of concerns, preventive behaviors, and thoughts on their healthcare provider's communication regarding COVID-19 in a US Midwestern state. In August 2020, a survey was sent to 10,009 Iowans aged 18 and older, randomly selected from the 2018 Iowa voter registration file. In September 2020, a survey was emailed to 2,954 cancer patients aged 18 and older who opted into the University of Iowa Holden Comprehensive Cancer Center's Patients Enhancing Research Collaborations at Holden program. Previously validated and pretested Likert-type and multiple-choice items assessed concern regarding COVID-19, social distancing perception and behaviors, and demographic characteristics of respondents. We used χ2 tests and logistic regression to examine differences between the cancer patient and general population survey responses. RESULTS: We included 3,622 responses from the general population survey and 780 responses from the cancer patient survey in this analysis. Cancer patient survey respondents were more frequently older, lived in urban areas, had Medicare insurance coverage, had a college degree or higher, and were married. Cancer patients were more likely to report engaging in social distancing behaviors and greater concern regarding the pandemic. CONCLUSION: This study suggests differences in the impact of the COVID-19 pandemic on cancer patients compared to cancer-free members of the general population. These results indicate the need for consideration of cancer patients' physical and mental health during large-scale disruptions to cancer care.

Rural and urban differences in perceptions, behaviors, and health care disruptions during the COVID-19 pandemic.

PURPOSE: The objective of this study was to assess perceptions, health behaviors, and disruptions related to the COVID-19 pandemic in a largely rural, Midwestern state, and to examine differences between rural and urban respondents. METHODS: A questionnaire was mailed August 2020 to a sample of 10,009 registered voters in Iowa ages 18-100 years, with oversampling from 6 select rural counties. Previously validated and tested items assessed COVID-19 precautions, health care disruptions, emotional reactions, health behavior changes, telehealth and experiences with the internet, and demographic characteristics. FINDINGS: There were 4,048 respondents (40% response rate); 65% were rural and 35% were urban residents. The average age of respondents was 58.3 years and 45% of respondents identified as female. Rural respondents reported less concern about COVID-19 in their community (29% vs 40%, P<.001) and lower perceived importance of social distancing (51% vs 64%, P<.001). Urban respondents more often reported experiencing disruption to daily living, stronger negative emotional reactions, and displayed more pronounced behavior change compared to their rural counterparts. For example, urban respondents reported more pandemic-related job losses (6% vs 4%, P = .05), disruptions to daily activities (48% vs 35%, P<.001), and use of telehealth services during the pandemic (24% vs 16%, P<.001). CONCLUSIONS: The majority of respondents reported disruptions to normal activities, medical appointment cancellations, and emotional distress during the first 6 months of the pandemic. The impact of the pandemic on urban residents appeared to be greater than for rural respondents. Timing of pandemic spread and varying beliefs are potential explanations.

A cluster randomized trial to evaluate a centralized remote clinical pharmacy service in large, health system primary care clinics.

Background: We developed a remote cardiovascular risk service (CVRS) managed by clinical pharmacists to support primary care teams. The purpose of this study was to examine whether the CVRS could improve guideline adherence in primary care clinics with diverse geographic and patient characteristics. Methods: This study was a cluster-randomized trial initiated in 20 primary care clinics across the US. Clinics were stratified as high or low minority and then randomized to receive the intervention or maintain usual care for 12 months. The primary outcome was adherence to relevant The Guideline Advantage (TGA) criteria met. TGA is a compilation of criteria from practice guidelines intended to improve the quality of primary care. Post-hoc outcomes included changes in individual TGA measures. Results: A total of 401 study subjects were included in the analysis. Mean TGA scores remained the same in the intervention group (n=193, 0.72) and slightly decreased in the usual care group (n=208, 0.67 to 0.66) over the 12-month study period. There was no significant difference between the mean TGA scores in intervention and usual care groups for the overall population at 12 months (0.72 versus 0.66 respectively, p=0.10). For under-represented minority subjects, there was no significant difference between TGA scores at 12 months (n=186; 0.70 versus 0.67, respectively, p=0.50). In a post-hoc analysis of subjects uncontrolled at baseline, there was a significant improvement in systolic BP at 12 months in the intervention group versus usual care (model-based difference of -8.03mmHg, p=0.03). Conclusions: Improvements in individual TGA measures were limited, in part, due to higher than expected baseline TGA scores. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02215408; https://clinicaltrials.gov/ct2/show/NCT02215408?id=NCT02215408.

Exploration of PCORnet Data Resources for Assessing Use of Molecular-Guided Cancer Treatment.

PURPOSE: Examine the ability of PCORnet data resources to investigate molecular-guided cancer treatment. PATIENTS AND METHODS: Patients (N = 86,154) had single primary solid tumors (diagnosed 2013-2017) from hospital oncology registries linked to the PCORnet Common Data Model (CDM) at 11 medical institutions. Molecular and anatomic test procedures and oral and infused therapies were identified with Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, RxNorm Concept Unique Identifier, and National Drug Codes from CDM tables. Chart review (2 institutions, n = 213) for advanced colorectal cancer and Medicare claims linkages (7 institutions, n = 1,731) for breast cancer explored options for increasing electronic data capture. RESULTS: Molecular testing prevalence detected via analyte-specific molecular CPT/HCPCS codes was 5.5% (n = 4,784); for the nonspecific anatomic pathology codes, for which only some testing is performed to guide therapy selection, it was an additional 44.8% (n = 38,610). Molecular-guided therapy prevalence was 5% (n = 4,289). Testing and treatment were most common with stage IV disease and varied across cancer types and study institutions (testing, 0%-10.4%; treatment, 0.8%-8.4%). Therapy-concordant test results were found in charts for all 36 treated patients with colorectal cancer at the 2 institutions, 3 (8.3%) of whom received treatment outside the institution. Breast cancer Medicare claims linkage increased rates of identified testing from 62.7%-98.9% and treatment from 3.9%-8.2%. CONCLUSION: Although a minority of patients received molecular-guided therapies, the majority had testing that could guide cancer treatment. Claims data extended electronic data capture for therapies and test orders but often was uninformative for types of test ordered. Test results continue to require text data curation from narrative pathology reports.

A Needs Assessment of Family Physicians to Inform Development of Educational Resources on Antipsychotic Use in Dementia.

OBJECTIVES: Objectives of this study were to (1) assess the needs and preferred resources of Iowa physicians to inform the development of educational resources for best practice dementia care and (2) compare the responses of nursing home medical directors with nonmedical directors. METHODS: Of 498 physicians, 101 (20%) completed and returned the survey. Family physicians were obtained from a list of family physicians from the Iowa Board of Medical Examiners. Respondent answers were summarized and presented as total numbers and percentages in tables. Significant differences between medical directors and nonmedical directors were evaluated using chi-square tests, Fisher exact tests, and Wilcoxon rank-sum tests. RESULTS: Medical directors and nonmedical directors had similar preferences for resources used and information needs. Online resources, pocket guides, a handbook, consulting pharmacists, and facility in-services were the most commonly preferred sources of new information. Medical directors were significantly more aware of the Food and Drug Administration warning on antipsychotic use in dementia and treated more nursing home patients. No differences were observed between groups related to confidence in and use of nondrug strategies instead of antipsychotics to manage behavioral symptoms of dementia. CONCLUSION: The results of this survey illustrate physician preferences for information and resources on the management of behavioral and psychological symptoms in dementia. Information was used to inform the development of resources to aid physicians and other health care providers in making decisions about managing these symptoms.

Upper extremity disability and quality of life after breast cancer treatment in the Greater Plains Collaborative clinical research network.

PURPOSE: Chronic upper extremity disability (UED) is common after breast cancer treatment but under-identified and under-treated. Although UED has been linked to quality of life (QoL), the role of UED as mediator between contemporary treatment practices and QoL has not been quantified. This investigation describes UED in a contemporary sample of breast cancer patients and examines its relationship with personal and treatment factors and QoL. METHODS: Eight hundred and thirty-three women diagnosed at eight medical institutions during 2013-2014 with microscopically confirmed ductal carcinoma in situ or invasive stage I-III breast cancer were surveyed an average of 22 months after diagnosis. UED was measured with a modified QuickDASH and QoL with the FACT-B. The questionnaire also collected treatments, sociodemographic information, comorbidity, body mass index, and a 3-item health literacy screener. RESULTS: Women who received post-mastectomy radiation and chemotherapy experienced significantly worse UED and QoL. Women who had lower income, lower health literacy and prior diabetes, arthritis or shoulder diagnoses had worse UED. Patients with worse UED reported significantly worse QoL. Income and health literacy were independently associated with QoL after adjustment for UED but treatment and prior conditions were not, indicating mediation by UED. UED mediated 52-79% of the effect of mastectomy-based treatments on QoL as compared with unilateral mastectomy without radiation. UED and QoL did not differ by type of axillary surgery or post-mastectomy reconstruction. CONCLUSIONS: A large portion of treatment effect on QoL is mediated by UED. Rehabilitation practices that prevent and alleviate UED are likely to improve QoL for breast cancer survivors.

Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices.

BACKGROUND: The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities. METHODS AND RESULTS: This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects. There was no improvement in the Guideline Advantage score from baseline to 12 months in the control group (64.7% versus 63.1%, respectively; P=0.21). There was a statistically significant improvement in the intervention group from 63.3% at baseline to 67.8% at 12 months (P=0.02). The estimated benefit of the intervention was 5.0%±2.4% (95% confidence interval=-0.5% to 10.4%; P=0.07). Several criteria were significantly better for intervention subjects, including appropriate statin therapy (P<0.001), body mass index, screening (P<0.001), and alcohol screening (P<0.001). Only 13.7% of subjects with diabetes mellitus had hemoglobin A1c at goal at baseline, and this increased to 30.8% and 21.0% in the intervention and control group, respectively, at 12 months (P=0.10). CONCLUSIONS: The centralized, remote pharmacist intervention was successfully implemented. The improvements in outcomes were modest, in part because of higher than expected baseline guideline adherence. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT 01983813.

Impact of programs to reduce antipsychotic and anticholinergic use in nursing homes.

INTRODUCTION: Antipsychotics are used for managing behavioral and psychological symptoms of dementia (BPSD) but have risks. Anticholinergics can worsen outcomes in dementia. The Improving Antipsychotic Appropriateness in Dementia Patients educational program (IA-ADAPT) and Centers for Medicare and Medicaid Services Partnership to Improve Dementia Care (CMS Partnership) promote improved care for BPSD. The purpose of this study was to evaluate the impact of these programs on medication use and BPSD among nursing home residents. METHODS: This quasi-experimental longitudinal study used Medicare and assessment data for Iowa nursing home residents from April 2011 to December 2012. Residents were required to be eligible for six continuous months for inclusion. Antipsychotic use and anticholinergic use were evaluated on a monthly basis, and changes in BPSD were tracked using assessment data. Results are presented as odds ratios (ORs) per month after exposure to the IA-ADAPT or the start of the CMS Partnership. RESULTS: Of 426 eligible Iowa nursing homes, 114 were exposed to the IA-ADAPT in 2012. Nursing home exposure to the IA-ADAPT was associated with reduced antipsychotic use (OR [95% CI] = 0.92 [0.89-0.95]) and anticholinergic use (OR [95% CI] = 0.95 [0.92-0.98]), reduced use of excessive antipsychotic doses per CMS guidance (OR [95% CI] = 0.80 [0.75-0.86]), increased odds of a potentially appropriate indication among antipsychotic users (OR [95% CI] = 1.04 [1.00-1.09]), and decreased documentation of verbal aggression (OR [95% CI] = 0.96 [0.94-0.99]). Facilities with two or more IA-ADAPT exposures had greater reductions in antipsychotic and anticholinergic use than those with only one. The CMS Partnership was associated with reduced antipsychotic use (OR [95% CI] = 0.96 [0.94-0.98]) and decreased documentation of any measured BPSD (OR [95% CI] = 0.98 [0.97-0.99]) as well as delirium specifically (OR [95% CI] = 0.98 [0.96-0.99]). DISCUSSION: This study suggests that the IA-ADAPT and the CMS Partnership improved medication use with no adverse impact on BPSD.

Selection bias and subject refusal in a cluster-randomized controlled trial.

BACKGROUND: Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. METHODS: The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE) study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site's allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. RESULTS: There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1.92). CONCLUSIONS: Though there appeared to be a higher consent rate for females than for males, the overall impact of potential selection bias and refusal to participate was minimal. Without rigorous methodology, selection bias may be a threat to external validity in cluster-randomized trials. TRIAL REGISTRATION: NCT01983813 . Date of registration: Oct. 28, 2013.

A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence.

BACKGROUND: Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular (CV) guidelines, medication adherence, and risk factor control. However, there is limited information on whether these models can be successfully implemented more widely in diverse settings and populations. The purpose of this study is to evaluate whether a centralized, web-based cardiovascular risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics. METHODS: This study is a prospective trial in 20 primary care offices stratified by the percent of under-represented minorities and then randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. The primary outcome is the difference in guideline adherence between groups. Data will also be abstracted from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS: Patient enrollment will continue through 2016, with results expected in 2019. This study will provide information on whether a distant, centralized CVRS can be implemented in large numbers of medical offices, if it is effective in diverse populations, and if there is a long-term sustained effect.

A centralized cardiovascular risk service to improve guideline adherence in private primary care offices.

BACKGROUND: Many large health systems now employ clinical pharmacists in team-based care to assist patients and physicians with management of cardiovascular (CV) diseases. However, small private offices often lack the resources to hire a clinical pharmacist for their office. The purpose of this study is to evaluate whether a centralized, web-based CV risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in primary care medical offices in rural and small communities. METHODS: This study is a cluster randomized prospective trial in 12 primary care offices. Medical offices were randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. Primary outcomes will include adherence to treatment guidelines and control of key CV risk factors. Data will also be abstracted from the medical record at 30 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS: This study will enroll subjects through 2015 and results will be available in 2018. This study will provide information on whether a distant, centralized CV risk service can improve guideline adherence in medical offices that lack the resources to employ clinical pharmacists.

Beyond comorbidity: expanding the definition and measurement of complexity among older adults using administrative claims data.

BACKGROUND: Studies of patients with multiple chronic conditions using claims data are often missing important determinants of treatments and outcomes, such as function status and disease severity. We sought to identify and evaluate a class of function-related indicators (FRIs) from administrative claims data. POPULATION: The study cohort comprised US Medicare beneficiaries aged 65 years or older with Parts A and B fee-for-service and Part D coverage, with a hospitalization for acute myocardial infarction during 2007. METHODS: Measures during the year before admission included the FRIs, demographics, conventional comorbidity measures, and prior hospitalization. Outcomes were receipt of cardiac catheterization during the index hospitalization and 12-month mortality. Model development used a random sample (n=72,056) with an equal sample for validation. RESULTS: In addition to prior cardiovascular conditions (85%), 40% had ≥1 comorbid condition, 30% were hospitalized in the prior 6 months, and 65% had ≥1 FRI [eg, delirium/dementia (22.7%), depression (16.7%), mobility limitation (16.1%), and chronic skin ulcers (12.6%)]. Including the FRIs improved mortality and cardiac catheterization prediction models (C-statistics 0.71 and 0.77, respectively). Patients with more cardiovascular conditions received less cardiac catheterization [minimally adjusted odds ratio (OR) 0.83; 95% confidence interval (CI), 0.82-0.83], as did patients with more comorbidities (minimally adjusted OR 0.70; 95% CI, 0.69-0.71), but this was attenuated by adjusting for functional status (fully adjusted OR for cardiovascular conditions 0.95; 95% CI, 0.94-0.96 and for comorbid conditions 0.94; 95% CI, 0.92-0.95). CONCLUSIONS: Claims data studies that include indicators of potentially diminished patient functional status better capture heterogeneity of patients with multiple chronic conditions.

Medication therapy management and complex patients with disability: a randomized controlled trial.

BACKGROUND: Drug therapy problems, adverse drug events (ADEs), and symptom burden are high among adults with disabilities. OBJECTIVE: To compare the effects of a modified medication therapy management (MTM) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations. METHODS: Three-group randomized controlled trial among adults (age 40 and older) with self-reported activity limitations in community practice. INTERVENTIONS: 8 weekly Living Well With a Disability (LWD) 2-hour workshop sessions with and without a collaborative medication management (CMM) module. PRIMARY OUTCOME: mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms. Process measures: changes in medication regimens and self-reported ADEs. ANALYSIS: general linear mixed models (continuous outcomes) and generalized estimating equations (categorical outcomes). RESULTS: Participants had high symptom burden, low physical health, and took many medications. There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups (Study group × Time P = .014), and there were significantly more changes in medication regimens in the LWD + CMM group (P = .013 LWD only vs LWD + CMM). The oldest third of participants had significantly fewer mean symptoms but received more intense CMM. There was no difference between the LWD-only, LWD + CMM, and usual care groups in symptom burden over time. CONCLUSION: Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations.

Personal health records: a randomized trial of effects on elder medication safety.

PURPOSE: To examine the impact of a personal health record (PHR) on medication-use safety among older adults. BACKGROUND: Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have. METHODS: A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems. RESULTS: Older adults were interested in keeping track of their health and medication information. A majority (55.2%) logged into the PHR and used it, but only 16.1% used it frequently. At follow-up, those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs-the most common warning generated by the system (viewed by 23% of participants). Compared with low/non-users, high users reported significantly more changes in medication use and improved medication reconciliation behaviors, and recognized significantly more side effects, but there was no difference in use of inappropriate medications or adherence measures. CONCLUSIONS: PHRs can engage older adults for better medication self-management; however, features that motivate continued use will be needed. Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes.

Efficacy and safety of nighttime dosing of antihypertensives: review of the literature and design of a pragmatic clinical trial.

Blood pressure exhibits circadian variability, and nighttime blood pressure is one of the best predictors of cardiovascular (CV) events. Adults with hypertension who lack a nighttime dipping pattern are at particularly high risk. Several studies have found that bedtime dosing of antihypertensive agents reduces sleep blood pressure and improves the dipping pattern in nondippers. One small study and 2 substudies of diabetes and chronic kidney disease suggest that bedtime dosing of ≥ 1 antihypertensives significantly reduced CV events. A Cochrane review of 5 studies found no difference in adverse events between morning and evening dosing. However, several evaluations in ophthalmology have found that nocturnal arterial hypotension precipitated ocular vascular disorders such as ischemic optic neuropathy. Some authors have suggested that additional studies of nighttime dosing of antihypertensive agents that evaluate CV events need to be conducted. The authors describe a randomized controlled pragmatic trial that is being planned at the University of Iowa and Duke University. Patients with hypertension and other comorbid conditions will be randomized to either continue morning dosing of all antihypertensive agents or to switch their nondiuretic medications to bedtime dosing. Patients will be followed for 36 to 42 months. This study will determine whether nighttime dosing reduces CV risk when compared with traditional morning dosing of antihypertensive agents.

Improving antipsychotic agent use in nursing homes: development of an algorithm for treating problem behaviors in dementia.

Many issues related to safety and quality care emerge from reports that nearly one in three nursing home residents is treated with antipsychotic medication, a rate that exceeds levels that led to nursing home reform more than 2 decades ago. Atypical antipsychotic medications have become the mainstay of treatment for behavioral problems among residents with dementia, despite federal "black box" warnings about health risks and research demonstrating their limited effectiveness. The purpose of this article is to briefly describe a dissemination research project designed to increase appropriate antipsychotic prescribing for older adults with dementia. A step-wise problem-solving algorithm designed to reduce unnecessary psychotropic medication use is described. Formative evaluation results provided by nursing home personnel are reviewed. Discussion focuses on nursing home culture as an important influence on the adoption of evidence-based practices and changes needed to promote use of behavioral interventions in dementia care and reduction of reliance on antipsychotic medications.

Older adults' views about "Managing Your Medications" booklet.

The objectives were to evaluate Managing Your Medications (MYM) booklet to improve medication management. Mailed packets, including MYM booklet and 4-page survey assessing comprehensibility, communicative effectiveness, and usefulness, were sent to a random sample of 250 older adults. The survey included perceptions of booklet, how to disseminate, and respondent's health history. Descriptive statistics were used, and individuals were stratified by number of prescription medications and whether they reported side effects. A 59.6% response rate was obtained. The readability was Grade 8. Older adults reported it was comprehensible and 17% reported behavioral intentions to change their current actions regarding medications. Overall, 12.7% of respondents agreed that MYM changed their opinion of the topic. The most popular means to disseminate were doctors' offices and senior citizens' centers. Most older adults indicated the MYM booklet was readable, comprehensible, and would generate some behavior change regarding medication management.

Dietary supplement polypharmacy: an unrecognized public health problem?

Excessive and inappropriate use of medications, or 'polypharmacy', has been recognized as a public health problem. In addition, there is growing use of dietary supplements in the United States; however, little is known about the patterns of supplement use. Recent reports in the literature of cases of excessive or inappropriate use of herbal dietary supplements leading to the term 'polyherbacy'. The clinical vignettes described in this article highlight the need for further research on the nature and extent of multiple and inappropriate dietary supplement use or 'dietary supplement polypharmacy'. Clinical interviewing and population surveys both address this issue in complementary ways, and provide a further understanding of dietary supplement use patterns.

Application of FDA adverse event report data to the surveillance of dietary botanical supplements.

BACKGROUND: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects. OBJECTIVE: To characterize data on DBSs associated with adverse event reports submitted to CAERS. METHODS: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. RESULTS: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. CONCLUSIONS: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.