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1.  Factors associated with use of pre-operative chemoradiation therapy for rectal cancer in the Cancer Care Outcomes Research and Surveillance Consortium 
American journal of clinical oncology  2013;36(6):10.1097/COC.0b013e318261082b.
Purpose
Pre-operative (pre-op) chemoradiation therapy (CRT) improves local control and reduces toxicity more than post-operative (post-op) CRT for the treatment of stages II/III rectal cancer, but studies suggest many patients still receive post-op CRT. We examined patient beliefs, and clinical and provider characteristics associated with receipt of recommended therapy.
Methods
We identified stage II/III rectal cancer patients who had primary site resection and CRT among subjects in the Cancer Care Outcomes Research and Surveillance Consortium, a population- and health system-based prospective cohort of newly diagnosed colorectal cancer patients from 2003 to 2005. Patient surveys and abstracted medical records were used to construct variables and determine sequence of CRT and surgery. Logistic regression was used to model the association between predictors and receipt of pre-op CRT.
Results
Of the 201 patients, 66% received pre-op and 34% received post-op CRT. Those visiting a medical oncologist and/or radiation oncologist prior to a surgeon had a 96% (95% CI, 92% to 100%) predicted probability of receiving pre-op CRT, compared to 48% (95% CI, 41% to 55%) for those visiting a surgeon first. Among those visiting a surgeon first, documentation of recommended staging procedures was associated with receiving pre-op CRT.
Conclusion
Sequence of provider visits and documentation of recommended staging procedures were important predictors of receiving pre-op CRT. Initial multidisciplinary evaluation led to better adherence to CRT guidelines. Further evaluation of provider characteristics, referral patterns and related health system processes should be undertaken to inform targeted interventions to reduce variation from recommended care.
doi:10.1097/COC.0b013e318261082b
PMCID: PMC3556239  PMID: 22992624
2.  Field methods in medical record abstraction: assessing the properties of comparative effectiveness estimates 
Background
Comparative effectiveness studies using Medicare claims data are vulnerable to treatment selection biases and supplemental data from a sample of patients has been recommended for examining the magnitude of this bias. Previous research using nationwide Medicare claims data has typically relied on the Medicare Current Beneficiary Survey (MCBS) for supplemental data. Because many important clinical variables for our specific research question are not available in the MCBS, we collected medical record data from a subsample of patients to assess the validity of assumptions and to aid in the interpretation of our estimates. This paper seeks to describe and document the process used to collect and validate this supplemental information.
Methods
Medicare claims data files for all patients with fee-for-service Medicare benefits who had an acute myocardial infarction (AMI) in 2007 or 2008 were obtained. Medical records were obtained and abstracted for a stratified subsample of 1,601 of these patients, using strata defined by claims-based measures of physician prescribing practices and drug treatment combinations. The abstraction tool was developed collaboratively by study clinicians and researchers, leveraging important elements from previously validated tools.
Results
Records for 2,707 AMI patients were requested from the admitting hospitals and 1,751 were received for an overall response rate of 65%; 1,601 cases were abstracted by trained personnel at a contracted firm. Data were collected with overall 96% inter-abstractor agreement across all variables. Some non-response bias was detected at the patient and facility level.
Conclusion
Although Medicare claims data are a potentially powerful resource for conducting comparative effectiveness analyses, observational databases are vulnerable to treatment selection biases. This study demonstrates that it is feasible to abstract medical records for Medicare patients nationwide and collect high quality data, to design the sampling purposively to address specific research questions, and to more thoroughly evaluate the appropriateness of care delivered to AMI patients.
doi:10.1186/1472-6963-14-391
PMCID: PMC4169833  PMID: 25223597
Acute myocardial infarction; Medical record abstraction; Medicare; Cardiovascular medications
3.  Sustained BP Control Following Discontinuation of a Pharmacist Intervention 
Team-based care can improve hypertension control. The purpose of the present study was to evaluate blood pressure control 18 months following the discontinuation of a physician-pharmacist collaborative intervention. This was a retrospective analysis of patients who had previously participated in a prospective, cluster randomized, controlled clinical trial. Six community-based family medicine offices were randomized to control or intervention groups. Research nurses measured blood pressures using an automated device during the prospective trial. The research nurses then abstracted data from medical records including blood pressures, medications, changes in therapy and laboratory values for 18 months following the discontinuation of the 6-month prospective trial. The study included 228 subjects in the control (n=146) or intervention (n=82) groups. The control group contained more patients with diabetes or chronic kidney disease (p<0.013) were older (p=0.047) with more co-existing conditions (p<0.001) than the intervention group. Systolic BP 9 months following discontinuation of the physician-pharmacist intervention was 137.2 ± 18.2 mm Hg and 129.8 ± 13.3 mm Hg in the control and intervention groups respectively (p=0.0015). BP control was maintained in 61 (41.8%) control patients and 55 (67.1%) intervention patients (p=0.0003). At 18 months post-intervention, systolic BP was 138.1 ± 20.4 mm Hg and 130.0 ± 16.0 mm Hg in the control and intervention groups respectively (p=0.023). BP control was maintained in 53 (36.3%) control patients and 55 (67.1%) intervention patients at 18 months post-intervention (p<0.0001). A sensitivity analysis was conducted to address the uneven distribution of subjects with diabetes or chronic kidney disease and the differences between groups were still significant. BP control rates remained significantly higher following a physician-pharmacist intervention compared to usual care for 18 months after discontinuation of the intervention. This model has the potential value as a useful long-term strategy to benefit patients with hypertension.
doi:10.1111/j.1751-7176.2011.00435.x
PMCID: PMC4126237  PMID: 21649843
hypertension management; clinical trial; pharmacist management; blood pressure control; guideline adherence
4.  What is the Effect of Area Size When Using Local Area Practice Style as an Instrument? 
Journal of clinical epidemiology  2013;66(8 0):S69-S83.
Many researchers have used local area practice style measures as instruments in instrumental variable analysis. What constitutes the size of a “local area” for measuring practice styles may affect the strength of the relationship between the instrument and treatment choice, and whether the instrument is related to unmeasured confounding factors. Among previous studies using local area practice style measures as instruments, only two reported whether their estimates were robust to changes in the local area size. There has been no discussion on how area size may affect IV estimates when local area practice style measures are used as instruments. The objective of this study is to discuss the tradeoffs inherent in choosing a local area size when using a measure of local area practice style as an instrument. We used the effectiveness of angiotensin converting-enzyme inhibitors and angiotensin receptor blockers on survival post acute myocardial infarction as an example. Across local area size definitions we contrasted treatment effect estimates in terms of (1) the strength of the relationship between local area practice styles and individual patient treatment choices; and (2) indirect assessments of the assumption of no correlation between local area practice style and unmeasured confounders.
doi:10.1016/j.jclinepi.2013.04.008
PMCID: PMC3718893  PMID: 23849157
5.  Expectations About the Effectiveness of Radiation Therapy Among Patients With Incurable Lung Cancer 
Journal of Clinical Oncology  2013;31(21):2730-2735.
Purpose
Although radiation therapy (RT) can palliate symptoms and may prolong life, it is not curative for patients with metastatic lung cancer. We investigated patient expectations about the goals of RT for incurable lung cancers.
Patients and Methods
The Cancer Care Outcomes Research and Surveillance Consortium enrolled a population- and health system–based cohort of patients diagnosed with lung cancer from 2003 to 2005. We identified patients with stage wet IIIB or IV lung cancer who received RT and answered questions on their expectations about RT. We assessed patient expectations about the goals of RT and identified factors associated with inaccurate beliefs about cure.
Results
In all, 384 patients completed surveys on their expectations about RT. Seventy-eight percent of patients believed that RT was very or somewhat likely to help them live longer, and 67% believed that RT was very or somewhat likely to help them with problems related to their cancer. However, 64% did not understand that RT was not at all likely to cure them. Older patients and nonwhites were more likely to have inaccurate beliefs, and patients whose surveys were completed by surrogates were less likely to have inaccurate beliefs. Ninety-two percent of patients with inaccurate beliefs about cure from RT also had inaccurate beliefs about chemotherapy.
Conclusion
Although patients receiving RT for incurable lung cancer believe it will help them, most do not understand that it is not at all likely to cure their disease. This indicates a need to improve communication regarding the goals and limitations of palliative RT.
doi:10.1200/JCO.2012.48.5748
PMCID: PMC3709058  PMID: 23775958
6.  Similar Blood Pressure Values Across Racial and Economic Groups: Baseline Data from a Group Randomized Clinical Trial 
This paper examines baseline characteristics from a prospective, cluster-randomized trial in 32 primary care offices. Offices were first stratified by percent minorities and level of clinical pharmacy services and then randomized into one of three study groups. The only differences between randomized arms were for marital status (p=0.03) and type of insurance coverage (p<0.001). BPs were similar in Caucasians and minority subjects, primarily Blacks, who were hypertensive at baseline. On multivariate analyses, subjects who were ≥ 65 years of age had higher systolic BP (SBP) (152.4 ± 14.3 mm Hg), but lower diastolic BP (DBP) (77.3 ± 11.8 mm Hg) compared to those <65 years of age (147.4 ± 15.0/88.6 ± 10.6 mm Hg, p<0.001 for both SBP and DBP). Other factors significantly associated with higher SBP were a longer duration of hypertension (p=0.04) and lower basal metabolic index (BMI) (p=0.011). Subjects with diabetes or chronic kidney disease (CKD) had a lower SBP than those without these conditions (p<0.0001). BP was similar across racial and socioeconomic groups for subjects with uncontrolled hypertension in primary care suggesting that subjects with uncontrolled hypertension and an established primary care relationship likely have different reasons for poor BP control than other patient populations.
doi:10.1111/jch.12091
PMCID: PMC3683891  PMID: 23730989
hypertension management; clinical trial; racial disparities; blood pressure control; medication adherence
7.  Palliative Radiation Therapy Practice in Patients With Metastatic Non–Small-Cell Lung Cancer: A Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) Study 
Journal of Clinical Oncology  2013;31(5):558-564.
Purpose
Randomized data suggest that single-fraction or short-course palliative radiation therapy (RT) is sufficient in the majority of patients with metastatic cancer. We investigated population-based patterns in the use of palliative RT among patients with metastatic non–small-cell lung cancer (NSCLC).
Patients and Methods
From patients diagnosed with lung cancer from 2003 to 2005 at a participating geographic or organizational site and who consented to the Cancer Care Outcomes Research and Surveillance Consortium study, we identified patients with metastatic NSCLC who had complete medical records abstractions. Patient characteristics and clinical factors associated with receipt of palliative RT and RT intensity (total dose and number of treatments) were evaluated with multivariable regression.
Results
Of 1,574 patients with metastatic NSCLC, 780 (50%) received at least one course of RT, and 21% and 12% received RT to the chest and bone, respectively. Use of palliative RT was associated with younger age at diagnosis and receipt of chemotherapy and surgery to metastatic sites. Among patients receiving palliative bone RT, only 6% received single-fraction treatment. Among patients receiving palliative chest RT, 42% received more than 20 fractions. Patients treated in integrated networks were more likely to receive lower doses and fewer fractions to the bone and chest.
Conclusion
When palliative RT is used in patients with metastatic NSCLC, a substantial proportion of patients receive a greater number of treatments and higher doses than supported by current evidence, suggesting an opportunity to improve care delivery.
doi:10.1200/JCO.2012.43.7954
PMCID: PMC3565181  PMID: 23295799
8.  Beers Criteria as a Proxy for Inappropriate Prescribing of Other Medications Among Older Adults 
The Annals of pharmacotherapy  2011;45(11):1363-1370.
BACKGROUND
The Beers criteria are a compilation of medications deemed potentially inappropriate for older adults, and widely used a prescribing quality indicator.
OBJECTIVE
To determine whether Beers criteria serve as a proxy measure for other forms of inappropriate prescribing, as measured by comprehensive implicit review.
METHODS
Data for patients 65 years and older were obtained from the VA Enhanced Pharmacy Outpatient Clinic (EPOC) and the Iowa Medicaid Pharmaceutical Case Management (PCM) studies. Comprehensive measurement of prescribing quality was conducted using expert clinician review of medical records according to the Medication Appropriateness Index (MAI). MAI scores attributable to non-Beers medications (non-Beers MAI) were contrasted between patients who did and did not receive a Beers criteria medication.
RESULTS
Beers criteria medications accounted for 12.9% and 14.0% of total MAI scores in the two studies. Importantly, non-Beers MAI scores were significantly higher in patients receiving a Beers criteria medication in both studies (EPOC: 15.1 vs. 12.4, p = 0.02; PCM: 11.1 vs. 8.7, p = 0.04), after adjusting for important confounding factors.
CONCLUSIONS
Beers criteria utility extended beyond direct measurement of a limited set of inappropriate prescribing practices by serving as a clinically meaningful proxy for other inappropriate practices. Using prescribing quality indicators to guide interventions should thus identify patients for comprehensive medication review, rather than identifying specific targets for discontinuation. Future research should explore both the quality measurement and the intervention targeting applications of the Beers criteria, particularly when integrated with other indicators.
doi:10.1345/aph.1Q361
PMCID: PMC3906722  PMID: 21972251
Beers criteria; inappropriate drug use; older adult; quality indicators; health care
9.  Accounting for Unobservable Exposure Time Bias When Using Medicare Prescription Drug Data 
Medicare & Medicaid Research Review  2013;3(4):mmrr.003.04.a01.
Objective
To describe the prevalence and correlates of unobservable medication exposure time, and to recommend approaches for minimizing bias, in studies using Medicare Part D data..
Sample
179,065 Medicare patients hospitalized for an AMI in 2007 or 2008.
Methods
We compared two methods for creating medication exposure observation periods using acute care discharge vs. post-acute care discharge dates. We examined options for increasing cohort sizes by requiring different thresholds for observable days, or by using as a covariate, in the observation period. We calculated the extent and health status correlates of unobserved Medicare Part D exposure time and examined its association with receipt of beta-blockers.
Results
39% of patients had unobservable time during the 30 day exposure assessment period following acute care; they were significantly older, had more comorbidity and longer acute care stays, had worse 1-year survival, and were significantly less likely to be classified as beta-blocker users. Using the alternative exposure assessment window, only 29% of the sample had unobservable time, and differences between groups were less pronounced. Significant gains in sample size can be obtained by restricting or controlling for the number of observable days required in the exposure assessment period.
Conclusions
Unobservable exposure time is common among Medicare Part D beneficiaries, and they are often in worse health. To retain patients with unobservable exposure time, we recommend stratifying patients on receipt of post-acute facility-based care, calculating and using observable days as a covariate and, when appropriate, using the discharge date from contiguous post-acute facility care for beginning the exposure assessment period.
doi:10.5600/mmrr.003.04.a01
PMCID: PMC4011646  PMID: 24834364
Administrative Data Uses; Epidemiology; Medicare; Pharmacy
10.  Standardizing Medicare Payment Information to Support Examining Geographic Variation in Costs 
Medicare & Medicaid Research Review  2013;3(3):mmrr.003.03.a06.
Objectives
Examination of efficiency in health care requires that cost information be normalized. Medicare payments include both geographic and policy-based facility type differentials (e.g., wage index and disproportionate share hospital), which can bias cost comparisons of hospitals and averages across geographic areas. Standardizing payment information to remove the area- and policy-based payment differentials should normalize much of the observed geographic variability in payments, allowing for a more accurate comparison of resource use between providers and across geographic regions. Use of standardized payments will ensure that observed payment variation is due to differences in practice patterns and service use, rather than Medicare payment differences over which the providers have no control. This paper describes a method for standardizing claim payments, and demonstrates the difference in actual versus standardized payments by geographic region.
Study Design and Methods
We used a nationwide cohort of Medicare patients hospitalized with an acute myocardial infarction (AMI) in 2007, then limited our study to those with Medicare Part A and Part B fee-for-service (FFS), and Part D coverage (n = 143,123). Standardized payment amounts were calculated for each Part A and Part B claim; standardized and actual payments were summed for all services for each patient beginning with the index hospitalization through 12 months post discharge.
Principal Findings
Without standardization of payments, certain areas of the country are mischaracterized as either high or low healthcare resource-consuming areas. The difference between actual and standardized payments varies by care setting.
Conclusions
Standardized payment amounts should be calculated when comparing Medicare resource use across geographic areas.
doi:10.5600/mmrr.003.03.a06
PMCID: PMC3983731  PMID: 24753972
Medicare; Administrative Data Uses; Health Care Costs; Medical Geography
11.  Demographic Differences in Incidence for Pituitary Adenoma 
Pituitary  2011;14(1):23-30.
Incidence estimates for pituitary adenomas vary widely, suggesting the effects of numerous risk factors or varying levels of tumor surveillance. We studied the epidemiology of pituitary adenomas using 2004–2007 data collected by 17 Surveillance, Epidemiology, and End Results (SEER) Programs in the United States (N = 8,276). We observed that incidence rates generally increased with age and were higher in females in early life and higher in males in later life. Males are diagnosed with larger tumors on average than females. Diagnosis may be delayed for males, giving tumors a chance to grow larger before clinical detection. We also observed that American Blacks have higher incidence rates for pituitary adenomas compared with other ethnic groups. There are several potential explanations for this finding with some evidence that at least part of the effect may be due to differential diagnosis between races.
doi:10.1007/s11102-010-0253-4
PMCID: PMC3652258  PMID: 20809113
pituitary; adenoma; incidence; race; sex
12.  Diffuse large B-cell lymphoma in the elderly: diffusion of treatment with rituximab and survival advances with and without anthracyclines 
Leukemia & lymphoma  2011;52(6):994-1002.
Anthracycline-based chemotherapy (ABC) is the most effective therapy for diffuse large B-cell lymphoma (DLBCL). The addition of rituximab to ABC in controlled trials has demonstrated superior survival, yet ABC is inconsistently utilized in elderly patients, and little is known about the penetrance or impact of rituximab with other treatments. We analyzed the treatment and survival patterns of 7559 patients with DLBCL over age 66 diagnosed from 1992 to 2002 using a linked Surveillance, Epidemiology and End Results (SEER)–Medicare database. Rituximab use was first detected in 1999 and by 2002 was incorporated in 79% of ABC-treated patients and 71% of patients treated with non-anthracycline chemotherapy, but only 12% of patients not receiving cytotoxic chemotherapy. ABC rates remained constant across time as did rates of no therapy, which were highest among the very old. Rituximab-associated survival improvements were seen among elderly treated with or without anthracyclines. Patients treated with rituximab but not anthracyclines had comparable survival to those treated with anthracycline but not rituximab.
doi:10.3109/10428194.2011.557167
PMCID: PMC3601377  PMID: 21338277
Non-Hodgkin lymphoma; immunotherapy; survival; elderly
14.  Survival Implications Associated with Variation in Mastectomy Rates for Early-Staged Breast Cancer 
Despite a 20-year-old guideline from the National Institutes of Health (NIH) Consensus Development Conference recommending breast conserving surgery with radiation (BCSR) over mastectomy for woman with early-stage breast cancer (ESBC) because it preserves the breast, recent evidence shows mastectomy rates increasing and higher-staged ESBC patients are more likely to receive mastectomy. These observations suggest that some patients and their providers believe that mastectomy has advantages over BCSR and these advantages increase with stage. These beliefs may persist because the randomized controlled trials (RCTs) that served as the basis for the NIH guideline were populated mainly with lower-staged patients. Our objective is to assess the survival implications associated with mastectomy choice by patient alignment with the RCT populations. We used instrumental variable methods to estimate the relationship between surgery choice and survival for ESBC patients based on variation in local area surgery styles. We find results consistent with the RCTs for patients closely aligned to the RCT populations. However, for patients unlike those in the RCTs, our results suggest that higher mastectomy rates are associated with reduced survival. We are careful to interpret our estimates in terms of limitations of our estimation approach.
doi:10.1155/2012/127854
PMCID: PMC3423912  PMID: 22928097
15.  Use of Colony-Stimulating Factors With Chemotherapy: Opportunities for Cost Savings and Improved Outcomes 
Myeloid colony-stimulating factors (CSFs) decrease the risk of febrile neutropenia (FN) from high-risk chemotherapy regimens administered to patients at 20% or greater risk of FN, but little is known about their use in clinical practice. We evaluated CSF use in a multiregional population-based cohort of lung and colorectal cancer patients (N = 1849). Only 17% (95% confidence interval [CI] = 8% to 26%) patients treated with high-risk chemotherapy regimens received CSFs, compared with 18% (95% CI = 16% to 20%) and 10% (95% CI = 8% to 12%) of patients treated with intermediate- (10%–20% risk of FN) and low-risk (<10% risk of FN) chemotherapy regimens, respectively. Using a generalized estimating equation model, we found that enrollment in a health maintenance organization (HMO) was strongly associated with a lower adjusted odds of discretionary CSF use, compared with non-HMO patients (odds ratio = 0.44, 95% CI = 0.32 to 0.60, P < .001). All statistical tests were two-sided. Overall, 96% (95% CI = 93% to 98%) of CSFs were administered in scenarios where CSF therapy is not recommended by evidence-based guidelines. This finding suggests that policies to decrease CSF use in patients at lower or intermediate risk of FN may yield substantial cost savings without compromising patient outcomes.
doi:10.1093/jnci/djr152
PMCID: PMC3119647  PMID: 21670423
16.  Outcomes following local therapy for early-stage breast cancer in non-trial populations 
Recent studies suggest trends toward more mastectomies for primary breast cancer treatment. We assessed survival after mastectomy and breast-conserving surgery (BCS) with radiation for early-stage breast cancer among non-selected populations of women and among women similar to those in clinical trials. Using population-based data from Surveillance Epidemiology, and End Results cancer registries linked with Medicare administrative data from 1992 to 2005, we conducted propensity score analysis of survival following primary therapy for early-stage breast cancer, including BCS with radiation, BCS without radiation, mastectomy with radiation, and mastectomy without radiation. Adjusted survival was greatest among women who had BCS with radiation (median survival = 10.98 years). Compared with this group, mortality was higher among women who had mastectomy without radiation (median survival 10.04 years, adjusted hazard ratio (HR) = 1.19, 95% confidence interval (CI) = 1.14–1.23), mastectomy with radiation (median survival 10.02 years, HR = 1.20, 95% CI = 1.14–1.27), and BCS without radiation (median survival 7.63 years, HR = 1.81, 95% CI = 1.70–1.92). Among women representative of those eligible for clinical trials (age ≤70 years, Charlson comorbidity score = 0/1, and stage 1 tumors), there were no differences in survival for women who underwent BCS with radiation or mastectomy. In conclusion, after careful adjustment for differences in patient, physician, and hospital characteristics, we found better survival for BCS with radiation versus mastectomy among older early-stage breast cancer patients, with no difference in survival for BCS with radiation versus mastectomy among women representative of those in clinical trials. These findings are reassuring in light of recent trends towards more aggressive primary breast cancer therapy.
doi:10.1007/s10549-010-0865-4
PMCID: PMC2924956  PMID: 20376555
Breast cancer; Surgery; Outcomes; Mastectomy; Breast conservation
17.  Clinical Variables Impacting Prescribing of Olanzapine, Quetiapine, and Risperidone 
Pharmacotherapy  2011;31(8):806-812.
Objective
To identify determinants of new use of the first-line SGAs associated with weight gain.
Design
Retrospective chart review.
Setting
Outpatient and inpatient psychiatry services at a tertiary, academic medical center.
Patients
Sample of 340 consecutive patients over two time periods with major depression with psychotic features, bipolar I, bipolar II, bipolar not otherwise specified, and schizoaffective disorder.
Interventions
None.
Measurements and Main Results
Clinical and sociodemographic variables associated with new use of olanzapine, risperidone, and quetiapine were identified using univariate and multivariate logistic regression. Several clinical factors were individually associated with initiation of these SGAs: mania (OR 3.6, 95% CI 1.2–10.8), psychosis (OR 3.3, 95% CI 1.5–6.9), and inpatient treatment (OR 3.8, 95% CI 1.8–7.9). Prevalent use of lithium (OR 0.3, 95% CI 0.1–0.9) and being married (OR 0.3, 95% CI 0.1–0.8) were inversely associated. Mania, psychosis, married status, and lithium use remained independently associated on multivariate analysis. Factors related to metabolic or vascular risk were not associated with SGA initiation.
Conclusions
Psychiatric clinicians weigh clinical features related to mental status and acuity heavily in determining whether to initiate SGAs. However, factors related to vascular risk were not associated. Future observational studies should consider current clinical status as an important factor in determining propensity to receive antipsychotics or other acute treatments for bipolar disorder.
doi:10.1592/phco.31.8.806
PMCID: PMC3192400  PMID: 21923607
Antipsychotic agents; Bipolar disorder; Inpatients; Logistic models; Major Depressive Disorder; Outpatients; Propensity Score; Psychotic Disorders
18.  Incidence of and risk factors for community-associated Clostridium difficile infection: A nested case-control study 
BMC Infectious Diseases  2011;11:194.
Background
Clostridium difficile is the most common cause of nosocomial infectious diarrhea in the United States. However, recent reports have documented that C. difficile infections (CDIs) are occurring among patients without traditional risk factors. The purpose of this study was to examine the epidemiology of CA-CDI, by estimating the incidence of CA-CDI and HA-CDI, identifying patient-related risk factors for CA-CDI, and describing adverse health outcomes of CA-CDI.
Methods
We conducted a population-based, retrospective, nested, case-control study within the University of Iowa Wellmark Data Repository from January 2004 to December 2007. We identified persons with CDI, determined whether infection was community-associated (CA) or hospital-acquired (HA), and calculated incidence rates. We collected demographic, clinical, and pharmacologic information for CA-CDI cases and controls (i.e., persons without CDI). We used conditional logistic regression to estimate the odds ratios (ORs) for potential risk factors for CA-CDI.
Results
The incidence rates for CA-CDI and HA-CDI were 11.16 and 12.1 cases per 100,000 person-years, respectively. CA-CDI cases were more likely than controls to receive antimicrobials (adjusted OR, 6.09 [95% CI 4.59-8.08]) and gastric acid suppressants (adjusted OR, 2.30 [95% CI 1.56-3.39]) in the 180 days before diagnosis. Controlling for other covariates, increased risk for CA-CDI was associated with use of beta-lactam/beta-lactamase inhibitors, cephalosporins, clindamycin, fluoroquinolones, macrolides, and penicillins. However, 27% of CA-CDI cases did not receive antimicrobials in the 180 days before their diagnoses, and 17% did not have any traditional risk factors for CDI.
Conclusions
Our study documented that the epidemiology of CDI is changing, with CA-CDI occurring in populations not traditionally considered "high-risk" for the disease. Clinicians should consider this diagnosis and obtain appropriate diagnostic testing for outpatients with persistent or severe diarrhea who have even remote antimicrobial exposure.
doi:10.1186/1471-2334-11-194
PMCID: PMC3154181  PMID: 21762504
19.  Prior Hospitalization and the Risk of Heart Attack in Older Adults: A 12-Year Prospective Study of Medicare Beneficiaries 
Background.
We investigated whether prior hospitalization was a risk factor for heart attacks among older adults in the survey on Assets and Health Dynamics among the Oldest Old.
Methods.
Baseline (1993–1994) interview data were linked to 1993–2005 Medicare claims for 5,511 self-respondents aged 70 years and older and not enrolled in managed Medicare. Primary hospital International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) 410.xx discharge codes identified postbaseline hospitalizations for acute myocardial infarctions (AMIs). Participants were censored at death or postbaseline managed Medicare enrollment. Traditional risk factors and other covariates were included. Recent postbaseline non-AMI hospitalizations (ie, prior hospitalizations) were indicated by a time-dependent marker, and sensitivity analyses identified their peak effect.
Results.
The total number of person-years of surveillance was 44,740 with a mean of 8.1 (median = 9.1) per person. Overall, 483 participants (8.8%) suffered postbaseline heart attacks, with 423 participants (7.7%) having their first-ever AMI. As expected, significant traditional risk factors were sex (men); race (whites); marital status (never being married); education (noncollege); geography (living in the South); and reporting a baseline history of angina, arthritis, diabetes, and heart disease. Risk factors were similar for both any postbaseline and first-ever postbaseline AMI analyses. The time-dependent recent non-AMI hospitalization marker did not alter the effects of the traditional risk factors but increased AMI risk by 366% (adjusted hazards ratio = 4.66, p < .0001).
Discussion.
Our results suggest that some small percentage (<3%) of heart attacks among older adults might be prevented if effective short-term postdischarge planning and monitoring interventions were developed and implemented.
doi:10.1093/gerona/glq003
PMCID: PMC2904597  PMID: 20106961
Heart attack; Recent hospitalization; Epidemiology; Prospective cohort study
20.  A Cluster-randomized Effectiveness Trial of a Physician\Pharmacist Collaborative Model to Improve Blood Pressure Control 
Background
Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study is to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained.
Methods
This study is a randomized prospective trial in 27 primary care offices first stratified by the percent of under-represented minorities and the level of clinical pharmacy services within the office. Each medical office was then randomized to either a 9 or 24 month intervention or to a control group. Patients will be enrolled in this study until 2012.
Conclusions
The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations and whether BP control can be sustained long-term.
doi:10.1161/CIRCOUTCOMES.109.908038
PMCID: PMC2931811  PMID: 20647575
hypertension management; clinical trial; pharmacist management; blood pressure control
21.  Continuity of Care with a Primary Care Physician and Mortality in Older Adults 
Background
We examined whether older adults who had continuity of care with a primary care physician (PCP) had lower mortality.
Methods
Secondary analyses were conducted using baseline interview data (1993–1994) from the nationally representative Survey on Assets and Health Dynamics among the Oldest Old (AHEAD). The analytic sample included 5,457 self-respondents 70 years old or more who were not enrolled in managed care plans. AHEAD data were linked to Medicare claims for 1991–2005, providing up to 12 years of follow-up. Two time-dependent measures of continuity addressed whether there was more than an 8-month interval between any two visits to the same PCP during the prior 2-year period. The “present exposure” measure calculated this criterion on a daily basis and could switch “on” or “off” daily, whereas the “cumulative exposure” measure reflected the percentage of follow-up days, also on a daily basis allowing it to switch on or off daily, for which the criterion was met.
Results
Two thousand nine hundred and fifty-four (54%) participants died during the follow-up period. Using the cumulative exposure measure, 27% never had continuity of care, whereas 31%, 20%, 14%, and 8%, respectively, had continuity for 1%–33%, 34%–67%, 68%–99%, and 100% of their follow-up days. Adjusted for demographics, socioeconomic status, social support, health lifestyle, and morbidity, both measures of continuity were associated (p < .001) with lower mortality (adjusted hazard ratios of 0.84 for the present exposure measure and 0.31, 0.39, 0.46, and 0.62, respectively, for the 1%–33%, 34%–67%, 68%–99%, and 100% categories of the cumulative exposure measure).
Conclusion
Continuity of care with a PCP, as assessed by two distinct measures, was associated with substantial reductions in long-term mortality.
doi:10.1093/gerona/glp188
PMCID: PMC2844057  PMID: 19995831
Continuity; Primary care; Mortality; Medical home
22.  Deterioration in BP Control Following Discontinuation of a Physician/Pharmacist Collaborative Intervention 
Pharmacotherapy  2010;30(3):228-235.
Study Objective
To evaluate blood pressure (BP) control following discontinuation of a physician\pharmacist collaborative intervention.
Design
BP was previously measured at baseline and at the end of a 9-month cluster-randomized intervention trial. This study abstracted medical record data for mean BP and BP control at 18 months (9 months after the discontinuation of the intervention) and at 27 months (18 months after discontinuation of the intervention).
Setting
Five primary care medical offices operated by a university health system.
Patients
Subjects with hypertension who were enrolled in a previous controlled trial and who consented to have data abstracted for an additional 18 months following the end of that study.
Intervention
A physician\pharmacist collaborative intervention to improve BP control was withdrawn after 9 months and BP and the change in BPs following withdrawal of the intervention were evaluated.
Measurements
A research nurse measured BP during the 9-month interventional study. BP values were then abstracted from the medical record for the 18 month period after the end of that study.
Main Results
104 patients had BP values at all 4 time periods. At baseline, systolic BP (SBP) was 152.5 ± 9.5 and 150.1 ± 9.6 mm Hg in the intervention and control groups, respectively (p=0.22). At 9 months, SBP decreased to 124.5 ± 10.7 and 132.0 ± 15.1 mm Hg (p=0.0038 between groups) and BP was controlled in 78.5% and 48.7% in the intervention and control groups, respectively (p=0.0017). By 18 months, SBP had deteriorated to 131.0 ± 12.2 and 143.3 ± 17.5 mm Hg (p<0.001) and BP control rates deteriorated to 53.9% and 30.8% in the intervention and control groups, respectively (p=0.02). By 27 months, SBP was 131.3 ± 13.0 and 141.2 ± 15.8 mm Hg (p=0.0008) and BP control was 55.3% and 35.9% in the intervention and control groups, respectively (p=0.05).
Conclusions
This study found a sustained effect on BP control up to 18 months following discontinuation of a pharmacist intervention. However, BP control deteriorated at a similar rate in both the intervention and control group but remained significantly higher in the intervention group. This study suggests that continued interventions by pharmacists may be necessary to maintain high rates of BP control, especially in those patients who lose BP control.
doi:10.1592/phco.30.3.228
PMCID: PMC2882166  PMID: 20180606
hypertension management; clinical trial; pharmacist management; team-care; blood pressure control
23.  Adverse Events Among the Elderly Receiving Chemotherapy for Advanced Non–Small-Cell Lung Cancer 
Journal of Clinical Oncology  2009;28(4):620-627.
Purpose
To describe chemotherapy use and adverse events (AEs) for advanced-stage, non–small-cell lung cancer (NSCLC) in community practice, including descriptions according to variation by age.
Methods
We interviewed patients with newly diagnosed, stages IIIB and IV NSCLC in the population-based cohort studied by the Cancer Care Outcomes Research and Surveillance Consortium, and we abstracted the patient medical records. AEs were medical events occurring during chemotherapy. Using logistic regression, we assessed the association between age and chemotherapy; with Poisson regression, we estimated event rate ratios and adjusted the analysis for age, sex, ethnicity, radiation therapy, stage, histology, and presence and grade of 27 comorbidities.
Results
Of 1,371 patients, 58% (95% CI, 55% to 61%) received chemotherapy and 35% (95% CI, 32% to 38%) had AEs. After adjustment, 72% (95% CI, 65% to 79%) of those younger than 55 years and 47% (95% CI, 42% to 52%) of those age 75 years and older received chemotherapy. Platinum-based therapies were less common in the older-age groups. Pretreatment medical event rates were 18.6% for patients younger than 55 years and were only 9.2% for those age 75 years and older (adjusted rate ratio, 0.49; 95% CI, 0.26 to 0.91). In contrast, older adults were more likely to have AEs during chemotherapy. The adjusted rate ratios compared with age younger than 55 years were 1.70 for 65- to 74-year-olds (95% CI, 1.19 to 2.43) and 1.34 for those age 75 years and older (95% CI, 0.90 to 2.00).
Conclusion
Older patients who received chemotherapy had fewer pretherapy events than younger patients and were less likely to receive platinum-based regimens. Nevertheless, older patients had more adverse events during chemotherapy, independent of comorbidity. Potential implicit trade-offs between symptom management and treatment toxicity should be made explicit and additionally studied.
doi:10.1200/JCO.2009.23.8485
PMCID: PMC2815997  PMID: 20038726
24.  Physician/Pharmacist Collaboration to Improve Blood Pressure Control 
Archives of internal medicine  2009;169(21):1996-2002.
Background
Studies have demonstrated that blood pressure (BP) control can be improved when clinical pharmacists assist with patient management. The purpose of this study was to evaluate the effectiveness of a physician/pharmacist intervention to improve BP control.
Methods
This was a prospective, cluster-randomized controlled clinical trial with clinics randomized to control (n=3) or intervention (n=3) groups. The study enrolled 402 patients with uncontrolled hypertension (mean age 58.3 years). Clinical pharmacists made drug-therapy recommendations to physicians based on national guidelines. Research nurses performed BP measurements and 24-hour BP monitoring.
Results
Guideline adherence scores increased from 49.4 ± 19.3 at baseline to 53.4 ± 18.1 at 6 months (9% increase) in the control group and from 40.4 ± 22.6 to 62.8 ± 13.5 (57% increase) in the intervention group (p=0.089 adjusted comparison between groups). Mean BP decreased 6.8/4.5 and 20.7/9.7 mm Hg in the control and intervention groups, respectively, (p<0.05 for between-group systolic BP (SBP) comparison). The adjusted difference in SBP was −12.0 (95% CI: −24.0, 0.0) mm Hg, while the difference in diastolic BP (DBP) was −1.8 (CI: −11.9, 8.3). The 24-hour BP levels showed similar effect sizes. BP was controlled in 29.9% of patients in the control group and 63.9% in the intervention group (adjusted odds ratio 3.2; CI: 2.0, 5.1; p<0.001).
Conclusions
A physician/pharmacist collaborative intervention achieved significantly better mean BP and overall BP control rates when compared to a control group. Additional research should be conducted to evaluate efficient strategies to implement team-based chronic disease management.
doi:10.1001/archinternmed.2009.358
PMCID: PMC2882170  PMID: 19933962
hypertension management; clinical trial; pharmacist management; blood pressure control; guideline adherence
25.  The Aftermath of Hip Fracture: Discharge Placement, Functional Status Change, and Mortality 
American Journal of Epidemiology  2009;170(10):1290-1299.
The authors prospectively explored the consequences of hip fracture with regard to discharge placement, functional status, and mortality using the Survey on Assets and Health Dynamics Among the Oldest Old (AHEAD). Data from baseline (1993) AHEAD interviews and biennial follow-up interviews were linked to Medicare claims data from 1993–2005. There were 495 postbaseline hip fractures among 5,511 respondents aged ≥69 years. Mean age at hip fracture was 85 years; 73% of fracture patients were white women, 45% had pertrochanteric fractures, and 55% underwent surgical pinning. Most patients (58%) were discharged to a nursing facility, with 14% being discharged to their homes. In-hospital, 6-month, and 1-year mortality were 2.7%, 19%, and 26%, respectively. Declines in functional-status-scale scores ranged from 29% on the fine motor skills scale to 56% on the mobility index. Mean scale score declines were 1.9 for activities of daily living, 1.7 for instrumental activities of daily living, and 2.2 for depressive symptoms; scores on mobility, large muscle, gross motor, and cognitive status scales worsened by 2.3, 1.6, 2.2, and 2.5 points, respectively. Hip fracture characteristics, socioeconomic status, and year of fracture were significantly associated with discharge placement. Sex, age, dementia, and frailty were significantly associated with mortality. This is one of the few studies to prospectively capture these declines in functional status after hip fracture.
doi:10.1093/aje/kwp266
PMCID: PMC2781759  PMID: 19808632
activities of daily living; hip fractures; mobility limitation; mortality; patient discharge

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