National Media Coverage of the Veterans Affairs Waitlist Scandal: Effects on Veterans' Distrust of the VA Health Care System.

BACKGROUND: On April 23, 2014, US media outlets broadcast reports of excessive wait times and "secret" waitlists at some Veterans Affairs (VA) hospitals, precipitating legislation to increase Veterans' access to private sector health care. OBJECTIVE: The aims were to assess changes in Veterans' distrust in the VA health care system before and after the media coverage and explore sex and racial/ethnic differences in the temporal patterns. METHODS: Veterans completed semistructured interviews on health care satisfaction from June 2013 to January 2015, including a validated scale of health system distrust (range: 1-5). We used linear splines with knots at 90-day intervals to assess changes in distrust before and after April 23, 2014 ("day 0") in linear mixed models. To explore sex and racial/ethnic differences in temporal patterns, we stratified models by sex and tested for interactions of race/ethnicity with time. RESULTS: For women (n=600), distrust scores (mean=2.09) increased by 0.45 in days 0-90 (P<0.01), then decreased by 0.45 in days 90-180 (P<0.01). Among men (n=575), distrust scores (mean=2.05) increased by 0.18 in days 0-90 (P=0.059). Distrust levels were significantly higher for Black versus White women (time adjusted mean difference=0.21) and for Black and Hispanic versus White men (differences=0.26 and 0.18). However, the temporal patterns did not vary by race/ethnicity for women or men (interaction P=0.85 and 0.21, respectively). CONCLUSIONS: Health system distrust increased in women following media coverage of VA access problems and was higher in Black/Hispanic versus White Veterans at all time periods. Such perceptions could influence Veteran decisions to seek health care in the community rather than VA.

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Veteran Satisfaction with Early Experiences of Health Care Through the Veterans Choice Program: a Concurrent Mixed Methods Study.

BACKGROUND: The 2014 Veterans Access, Choice and Accountability Act (i.e., "Choice") allows eligible Veterans to receive covered health care outside the Veterans Affairs (VA) Healthcare System. The initial implementation of Choice was challenging, and use was limited in the first year. OBJECTIVE: To assess satisfaction with Choice, and identify reasons for satisfaction and dissatisfaction during its early implementation. DESIGN AND PARTICIPANTS: Semi-structured telephone interviews from July to September 2015 with Choice-eligible Veterans from 25 VA facilities across the USA. MAIN MEASURES: Satisfaction was assessed with 5-point Likert scales and open-ended questions. We compared ratings of satisfaction with Choice and VA health care, and identified reasons for satisfaction/dissatisfaction with Choice in a thematic analysis of open-ended qualitative data. RESULTS: Of 195 participants, 35 had not attempted to use Choice; 43 attempted but had not received Choice care (i.e., attempted only); and 117 attempted and received Choice care. Among those who attempted only, a smaller percentage were somewhat/very satisfied with Choice than with VA health care (17.9% and 71.8%, p < 0.001); among participants who received Choice, similar percentages were somewhat/very satisfied with Choice and VA health care (66.6% and 71.1%, p = 0.45). When asked what contributed to Choice ratings, participants who attempted but did not receive Choice care reported poor access (50%), scheduling problems (20%), and care coordination issues (10%); participants who received Choice care reported improved access (27%), good quality of care (19%), and good distance to Choice provider (16%). Regardless of receipt of Choice care, most participants expressed interest in using Choice in the future (70-82%). CONCLUSIONS: Access and scheduling barriers contributed to dissatisfaction for Veterans unsuccessfully attempting to use Choice during its initial implementation, whereas improved access and good care contributed to satisfaction for those receiving Choice care. With Veterans' continued interest in using services outside VA facilities, subsequent policy changes should address Veterans' barriers to care.

Racial, Ethnic, and Gender Equity in Veteran Satisfaction with Health Care in the Veterans Affairs Health Care System.

BACKGROUND: Patient satisfaction is an important dimension of health care quality. The Veterans Health Administration (VA) is committed to providing high-quality care to an increasingly diverse patient population. OBJECTIVE: To assess Veteran satisfaction with VA health care by race/ethnicity and gender. DESIGN AND PARTICIPANTS: We conducted semi-structured telephone interviews with gender-specific stratified samples of black, white, and Hispanic Veterans from 25 predominantly minority-serving VA Medical Centers from June 2013 to January 2015. MAIN MEASURES: Satisfaction with health care was assessed in 16 domains using five-point Likert scales. We compared the proportions of Veterans who were very satisfied, somewhat satisfied, and less than satisfied (i.e., neither satisfied nor dissatisfied, somewhat dissatisfied, or very dissatisfied) in each domain, and used random-effects multinomial regression to estimate racial/ethnic differences by gender and gender differences by race/ethnicity. KEY RESULTS: Interviews were completed for 1222 of the 1929 Veterans known to be eligible for the interview (63.3%), including 421 white, 389 black, and 396 Hispanic Veterans, 616 of whom were female. Veterans were less likely to be somewhat satisfied or less than satisfied versus very satisfied with care in each of the 16 domains. The highest satisfaction ratings were reported for costs, outpatient facilities, and pharmacy (74-76% very satisfied); the lowest ratings were reported for access, pain management, and mental health care (21-24% less than satisfied). None of the joint tests of racial/ethnic or gender differences in satisfaction (simultaneously comparing all three satisfaction levels) was statistically significant (p > 0.05). Pairwise comparisons of specific levels of satisfaction revealed racial/ethnic differences by gender in three domains and gender differences by race/ethnicity in five domains, with no consistent directionality across demographic subgroups. CONCLUSIONS: Our multisite interviews of a diverse sample of Veterans at primarily minority-serving sites showed generally high levels of health care satisfaction across 16 domains, with few quantitative differences by race/ethnicity or gender.

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.

BACKGROUND: Despite perceptions that institutional review boards (IRBs) delay research, little is known about how long it takes to secure IRB approval. We retrospectively quantified IRB review times at 10 large Veterans Affairs (VA) IRBs. METHODS: We collected IRB records pertaining to a stratified random sample of research protocols drawn from 10 of the 26 largest VA IRBs. Two independent analysts abstracted dates from the IRB records, from which we calculated overall and incremental review times. We used multivariable linear regression to assess variation in total and incremental review times by IRB and review level (i.e., exempt, expedited, or full board) and to identify potential targets for efforts to improve the efficiency and uniformity of the IRB review process. RESULTS: In a sample of 277 protocols, the mean review time was 112 d (95% confidence interval [CI]: 105-120). Compared with full-board reviews at IRB 1, average review times at IRBs 3, 8, 9, and 10 were 27 (95% CI: 6-48), 37 (95% CI: 11-63), 45 (95% CI: 20-69), and 24 (95% CI: 2-45) d shorter, and at IRB 6, times were 56 (95% CI: 28-84) d longer. Across all IRBs, expedited reviews were 44 (95% CI: 30-58) d shorter on average than were full-board reviews, with no significant difference between exempt and full-board reviews. However, after subtracting the time required for Research and Development Committee review, exempt reviews were 21 (95% CI: 1-41) d shorter on average than were full-board reviews. CONCLUSIONS: IRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 d for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for Research and Development Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.

Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial.

The purpose of this 2-arm randomized clinical trial was to evaluate the effectiveness of a 12-month, expert system-based, print-delivered physical activity intervention in a primary care Veteran population in Pittsburgh, Pennsylvania. Participants were not excluded for many health conditions that typically are exclusionary criteria in physical activity trials. The primary outcome measures were physical activity reported using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and an accelerometer-based activity assessment at baseline, 6, and 12 months. Of the 232 Veterans enrolled in the study, 208 (89.7%) were retained at the 6-month follow-up and 203 (87.5%) were retained at 12 months. Compared to the attention control, intervention participants had significantly increased odds of meeting the U.S. recommended guideline of ≥ 150 min/week of at least moderate-intensity physical activity at 12 months for the modified CHAMPS (odds ratio [OR] = 2.86; 95% CI: 1.03-7.96; p = 0.04) but not at 6 months (OR = 1.54; 95% CI: 0.56-4.23; p = 0.40). Based on accelerometer data, intervention participants had significantly increased odds of meeting ≥ 150 min/week of moderate-equivalent physical activity at 6 months (OR = 6.26; 95% CI: 1.26-31.22; p = 0.03) and borderline significantly increased odds at 12 months (OR = 4.73; 95% CI: 0.98-22.76; p = 0.053). An expert system physical activity counseling intervention can increase or sustain the proportion of Veterans in primary care meeting current recommendations for moderate-intensity physical activity. Trial Registration Clinical trials.gov identifier: NCT00731094 URL: http://www.clinicaltrials.gov/ct2/show/NCT00731094.

No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study.

OBJECTIVE: To evaluate the efficacy of behavioral counseling combined with technology-based self-monitoring for sodium restriction in hemodialysis (HD) patients. DESIGN: Randomized clinical trial. SUBJECTS: English literate adults undergoing outpatient, in-center intermittent HD for at least 3 months. INTERVENTIONS: Over a 16-week period, both the intervention and the attention control groups were shown 6 educational modules on the HD diet. The intervention group also received social cognitive theory-based behavioral counseling and monitored their diets daily using handheld computers. MAIN OUTCOME MEASURES: Average daily interdialytic weight gain (IDWGA) was calculated for every week of HD treatment over the observation period by subtracting the post-dialysis weight at the previous treatment time (t-1) from the pre-dialysis weight at the current treatment time (t), dividing by the number of days between treatments. Three 24-hour dietary recalls were obtained at baseline, 8 weeks, and 16 weeks and evaluated using the Nutrient Data System for Research. RESULTS: A total of 179 participants were randomized, and 160 (89.4%) completed final measurements. IDWGA did not differ significantly by treatment group at any time point considered (P > .79 for each). A significant differential change in dietary sodium intake observed at 8 weeks (-372 mg/day; P = .05) was not sustained at 16 weeks (-191 mg/day; P = .32). CONCLUSION: The BalanceWise Study intervention appeared to be feasible and acceptable to HD patients although IDWGA was unchanged and the desired behavioral changes observed at 8 weeks were not sustained. Unmeasured factors may have contributed to the mixed findings, and further research is needed to identify the appropriate patients for such interventions.

Adapting the Index of Relative Rurality (IRR) to Estimate Rurality at the ZIP Code Level: A Rural Classification System in Health Services Research.

BACKGROUND: Accurate analysis of health problems facing rural residents depends on how rurality is defined. Health services research relies frequently on the rural urban commuting area (RUCA) codes to estimate rurality at the small area level. We modified the county-level Index of Relative Rurality (IRR) to the ZIP code level (IRRZIP ) to create an alternative small-area-level rural classification system. We then compared how the 2 rural classification systems differ in how rural areas and populations are defined and in methodological analysis. METHODS: We linked data for veterans (n = 37,466) who attended the VA Pittsburgh Healthcare System to 2000 United States Census and the US Department of Agriculture's Economic Research Service data. RESULTS: The RUCA and the IRRZIP do not consistently classify the same ZIP code areas and populations as rural. Using the IRRZIP , each 10th increment in increased rurality was associated with a 2.6 increased odds of receiving primary care at a satellite clinic. CONCLUSIONS: The IRRZIP is a straightforward measure that is easy to use and interpret and may be a relevant alternative rural classification system that can be used in health services research.

Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.

BACKGROUND: Institutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs. METHODS: 680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB. RESULTS: 390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified. CONCLUSIONS: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.

Using the IRB Researcher Assessment Tool to Guide Quality Improvement.

Institutional Review Boards (IRBs) are intended to protect those who participate in research. However, because there is no established measure of IRB quality, it is unclear whether these committees achieve their goal. The IRB Researcher Assessment Tool is a previously validated, internally normed, proxy measure of IRB quality that assesses 45 distinct IRB activities and functions. We administered this instrument to a sample of investigators and IRB members at a large urban VA Medical Center. We describe a systematic approach to analyze and interpret survey responses that can identify the IRB activities and functions most in need of quality improvement. The proposed approach to empirical data analysis and presentation could inform local initiatives to improve the quality of IRB review.

Adjuvant chemotherapy for stage III colon cancer: relative dose intensity and survival among veterans.

BACKGROUND: Given the paucity of information on dose intensity, the objective of this study is to describe the use of adjuvant chemotherapy for stage III colon cancer, focusing on relative dose intensity (RDI), overall survival (OS) and disease-free survival (DFS). METHODS: Retrospective cohort of 367 patients diagnosed with stage III colon cancer in 2003-2008 and treated at 19 VA medical centers. Kaplan-Meier curves summarize 5-year OS and 3-year DFS by chemotherapy regimen and RDI, and multivariable Cox proportional hazards regression was used to model these associations. RESULTS: 5-fluorouracil/leucovorin (FU/LV) was the most commonly initiated regimen in 2003 (94.4%) and 2004 (62.7%); in 2005-2008, a majority of patients (60%-74%) was started on an oxaliplatin-based regimen. Median RDI was 82.3%. Receipt of >70% RDI was associated with better 5-year OS (p < 0.001) and 3-year DFS (P = 0.009) than was receipt of ≤70% RDI, with 5-year OS rates of 66.3% and 50.5%, respectively and 3-year DFS rates of 66.1% and 52.7%, respectively. In the multivariable analysis of 5-year OS, oxaliplatin + 5-FU/LV (versus 5-FU/LV) (HR = 0.55; 95% CI = 0.34-0.91), >70% RDI at the first year (HR = 0.58; 95% CI = 0.37-0.89) and married status (HR = 0.66; 95% CI = 0.45-0.97) were associated with significantly decreased risk of death, while age ≥75 (versus 55-64) (HR = 2.06; 95% CI = 1.25-3.40), Charlson Comorbidity Index (HR = 1.17; 95% CI = 1.06-1.30), T4 tumor status (versus T1/T2) (HR = 5.88; 95% CI = 2.69-12.9), N2 node status (HR = 1.68; 95% CI = 1.12-2.50) and bowel obstruction (HR = 2.32, 95% CI = 1.36-3.95) were associated with significantly increased risk. Similar associations were observed for DFS. CONCLUSION: Patients with stage III colon cancer who received >70% RDI had improved 5-year OS. The association between RDI and survival needs to be examined in studies of adjuvant chemotherapy for colon cancer outside of the VA.

Potentially suboptimal prescribing for older veteran nursing home patients with dementia.

BACKGROUND: Nursing home patients with dementia may be more likely to suffer adverse drug events from suboptimal prescribing. Previous studies have not used national samples, nor have they examined multiple types of suboptimal prescribing by dementia severity. OBJECTIVE: To examine the prevalence of and factors associated with potentially suboptimal prescribing in older veteran nursing home patients with dementia. METHODS: This is a retrospective descriptive study of 1303 veterans 65 years or older admitted between January 1, 2004, and June 30, 2005, with dementia for long stays (90+ days) to 133 Veterans Affairs Community Living Centers. Dementia severity was determined by the Cognitive Performance Scale and functional status dependences. RESULTS: Overall, 70.2% with mild-moderate dementia (n = 1076) had underuse because they did not receive an acetylcholinesterase inhibitor (AChEI), and 27.2% had evidence of inappropriate use because of a drug-disease or drug-drug-disease interaction. Of the 227 with severe dementia, 36.1% had overuse by receiving an AChEI or lipid-lowering or other agents, and 25.1% had evidence of inappropriate use as a result of a drug-disease or drug-drug interaction. Multinomial logistic regression analyses among those with mild to moderate dementia identified that living in the South versus other regions was the single factor associated with all 3 types of suboptimal prescribing. In those with severe dementia, antipsychotic use was associated with all 3 suboptimal prescribing types. CONCLUSIONS: Potentially suboptimal prescribing was common in older veteran nursing home patients with dementia. Clinicians should develop a heightened awareness of these problems. Future studies should examine associations between potentially suboptimal prescribing and health outcomes in patients with dementia.

Racial Differences in Satisfaction with VA Health Care: A Mixed Methods Pilot Study.

INTRODUCTION: As satisfied patients are more adherent and play a more active role in their own care, a better understanding of factors associated with patient satisfaction is important. PURPOSE: In response to a United States Veterans Administration (VA) Hospital Report Card that revealed lower levels of satisfaction with health care for African Americans compared to Whites, we conducted a mixed methods pilot study to obtain preliminary qualitative and quantitative information about possible underlying reasons for these racial differences. METHODS: We conducted telephone interviews with 30 African American and 31 White veterans with recent inpatient and/or outpatient health care visits at three urban VA Medical Centers. We coded the qualitative interviews in terms of identified themes within defined domains. We summarized racial differences using ordinal logistic regression for Likert scale outcomes and used random effects logistic regression to assess racial differences at the domain level. RESULTS: Compared to Whites, African Americans were younger (p < 0.001) and better educated (p = 0.04). Qualitatively, African Americans reported less satisfaction with trust/confidence in their VA providers and healthcare system and less satisfaction with patient-provider communication. Quantitatively, African Americans reported less satisfaction with outpatient care (odds ratio = 0.28; 95 % confidence interval (CI) 0.10-0.82), but not inpatient care. At the domain level, African Americans were significantly less likely than Whites to express satisfaction themes in the domain of trust/confidence (odds ratio = 0.36; 95 % CI 0.18-0.73). CONCLUSION: The current pilot study demonstrates racial differences in satisfaction with outpatient care and identifies some specific sources of dissatisfaction. Future research will include a large national cohort, including Hispanic veterans, in order to gain further insight into the sources of racial and ethnic differences in satisfaction with VA care and inform future interventions.

Epidemiology of drug-disease interactions in older veteran nursing home residents.

OBJECTIVES: To describe the prevalence of and factors associated with drug-disease interactions (DDIs) in older nursing home residents according to the American Geriatrics Society 2012 Beers Criteria. DESIGN: Cross-sectional. SETTING: Fifteen Veterans Affairs Community Living Centers. PARTICIPANTS: Individuals aged 65 and older with a diagnosis of dementia or cognitive impairment, a history of falls or hip fracture, heart failure (HF), a history of peptic ulcer disease (PUD), or Stage IV or V chronic kidney disease (CKD). MEASUREMENTS: Medications that could exacerbate the above conditions (DDIs). RESULTS: Three hundred sixty-one of 696 (51.9%) eligible residents had one or more DDIs. None involved residents with a history of PUD, one involved a resident with CKD, and four occurred in residents with HF. Of 540 residents with dementia or cognitive impairment, 50.7% took a drug that could exacerbate these conditions; the most commonly involved medications were antipsychotics (35.4%) and benzodiazepines (14.4%). Of 267 with a history of falls or hip fracture, 67.8% received an interacting medication, with selective serotonin reuptake inhibitors (33.1%), antipsychotics (30.7%), and anticonvulsants (25.1%) being most commonly involved. Using separate multivariable logistic regression models, factors associated with DDIs in dementia or cognitive impairment and falls or fractures included age 85 and older (adjusted odds ratio (aOR) = 0.38, 95% confidence interval (CI) = 0.24-0.60 and aOR = 0.48, 95% CI = 0.24-0.96, respectively), taking five to eight medications (aOR = 2.06, 95% CI = 1.02-4.16 and aOR = 4.76, 95% CI = 1.68-13.5, respectively), taking nine or more medications (aOR = 1.99, 95% CI = 1.03-3.85 and aOR = 3.68, 95% CI = 1.41-9.61, respectively), and being a long-stay resident (aOR = 1.80, 95% CI = 1.04-3.12 and aOR = 2.35, 95% CI = 1.12-4.91, respectively). CONCLUSION: DDIs were common in older nursing home residents with dementia or cognitive impairment or a history of falls or fractures.

Time required for institutional review board review at one Veterans Affairs medical center.

IMPORTANCE: Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. OBJECTIVE: To measure the overall and incremental process times for IRB review as a process of quality improvement. DESIGN, SETTING, AND PARTICIPANTS: After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. MAIN OUTCOMES AND MEASURES: Calendar days from initial submission to final approval of research protocols. RESULTS: Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. CONCLUSIONS AND RELEVANCE: Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies.

Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study.

BACKGROUND: Much of the existing literature on physical activity (PA) interventions involves physically inactive individuals recruited from community settings rather than clinical practice settings. Recruitment of patients into interventions in clinical practice settings is difficult due to limited time available in the clinic, identification of appropriate personnel to efficiently conduct the process, and time-consuming methods of recruitment. The purpose of this report is to describe the approach used to identify and recruit veterans from the Veterans Affairs (VA) Pittsburgh Healthcare System Primary Care Clinic into a randomized controlled PA study. METHODS: A sampling frame of veterans was developed using the VA electronic medical record. During regularly scheduled clinic appointments, primary care providers (PCPs) screened identified patients for safety to engage in moderate-intensity PA and willingness to discuss the study with research staff members. Research staff determined eligibility with a subsequent telephone screening call and scheduled a research study appointment, at which time signed informed consent and baseline measurements were obtained. RESULTS: Of the 3,482 veterans in the sampling frame who were scheduled for a primary care appointment during the study period, 1,990 (57.2%) were seen in the clinic and screened by the PCP; moderate-intensity PA was deemed safe for 1,293 (37.1%), 871 (25.0%) agreed to be contacted for further screening, 334 (9.6%) were eligible for the study, and 232 (6.7%) enrolled. CONCLUSIONS: Using a semiautomated screening approach that combined an electronically-derived sampling frame with paper and pencil prescreening by PCPs and research staff, VA-STRIDE was able to recruit 1 in 15 veterans in the sampling frame. Using this approach, a high proportion of potentially eligible veterans were screened by their PCPs. TRIAL REGISTRATION: Clinical trials.gov identifier: NCT00731094.

FDA warning and removal of rosiglitazone from VA national formulary.

OBJECTIVES: To describe changes in rosiglitazone prescribing following the US Food and Drug Administration (FDA) warning of potentially increased risk of myocardial infarction and removal from the Department of Veterans Affairs National Formulary (VANF), assess patient-level factors associated with rosiglitazone discontinuation, and evaluate changes in glucose control. STUDY DESIGN: Historical cohort. METHODS: Veterans with an active outpatient prescription for rosiglitazone on April 1, 2007, were followed until June 30, 2008. Incidence rate ratios (IRRs) of rosiglitazone discontinuation were compared over time using Poisson methods. We identified patient-level factors associated with stopping rosiglitazone using multivariable Poisson regression and compared glycated hemoglobin (A1C) values across time among patients who discontinued/continued rosiglitazone using linear mixed models. RESULTS: Of 95,539 veterans with an active outpatient rosiglitazone prescription, 86.7% discontinued rosiglitazone. Discontinuation rates increased significantly after the FDA warning, with IRRs from 1.6 to 1.8. After removal from the VANF, rosiglitazone discontinuation rates again increased significantly. Discontinuing rosiglitazone was associated with the FDA warning, removal from the VANF, female sex, black race, Hispanic ethnicity, comorbidity, A1C greater than 9%, and use of rosiglitazone as first- or second-line therapy. Among patients who did and did not receive a replacement medication, the mean changes in A1C from baseline were 0.12% and 0.46%, respectively. For those who continued rosiglitazone, the mean change in A1C was -0.02%. CONCLUSION: The rosiglitazone discontinuation rate increased following the FDA warning and increased further following removal of rosiglitazone from the VANF. Glucose control may have declined among those who discontinued rosiglitazone.

Incremental cost effectiveness of pharmacist-managed erythropoiesis-stimulating agent clinics for non-dialysis-dependent chronic kidney disease patients.

BACKGROUND: Pharmacists successfully manage patients with anemia and chronic kidney disease (CKD), but the cost effectiveness of these programs is unknown. OBJECTIVE: To compare the cost effectiveness of pharmacist-managed erythropoiesis-stimulating agent (ESA) clinics with that of usual care in patients with non-dialysis-dependent (NDD)-CKD. METHODS: A Markov model was used to estimate the incremental cost effectiveness of pharmacist-managed ESA clinics compared with usual care in outpatient veterans receiving ESAs for NDD-CKD in 2009. The analysis was conducted from a US Veterans Health Administration perspective with a 5-year time horizon, and the year of valuation for cost results was 2012. The effect of parameter uncertainty was explored in one-way and probabilistic sensitivity analyses. RESULTS: In the deterministic base case analysis, costs and effectiveness per patient over 5 years were US$13,412 and 2.096 quality-adjusted life-years (QALYs) in the pharmacist-managed ESA clinics and US$16,173 and 2.093 QALYs in usual care; ESA clinics dominated usual care. In one-way sensitivity analyses, ESA clinics no longer dominated if their patients' probability of being in the target hemoglobin range fell to 52 % (base case 71 %) or if the mean cost/patient/month of epoetin or darbepoetin in ESA clinics increased to approximately US$382 (base case US$226) or US$477 (base case US$268), respectively. When all parameters were varied simultaneously in a probabilistic sensitivity analysis, ESA clinics were favored ≥80 % of the time at willingness-to-pay thresholds of US$0-$100,000 per QALY gained. CONCLUSIONS: Pharmacist-managed ESA clinics were less costly and more effective than usual care in patients receiving ESAs for anemia and NDD-CKD. Results were robust to variation and support the use of pharmacist-managed ESA clinics.