MMPI-2-RF Profiles of Treatment-Seeking Veterans in a VA Pain Clinic and Associations with Markers of Physical Performance.

Chronic pain is a debilitating condition for many military Veterans and is associated with posttraumatic stress disorder (PTSD). This study examined the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) in 144 Veterans (88.2% male, mean age = 57.95 years) recruited from a VA outpatient pain clinic and associations with self-reported pain severity, pain-related interference in daily activities, prescription opioid use, and objective metrics of physical performance on tasks impacted by pain (walking, stair climbing, grip strength, indexed by a single latent variable). Among the cohort with valid responses on the MMPI-2-RF (n = 117) and probable PTSD, mean Somatic Complaints (RC1) and Ideas of Persecution (RC6) scores were clinically elevated. All MMPI-2-RF scales were more strongly correlated with self-reported pain interference than severity. Regressions revealed associations between self-rated pain interference (but not pain or PTSD severity) and physical performance scores (ß = .36, p = .001). MMPI-2-RF overreporting Validity and Higher-Order scales contributed incremental variance in predicting physical performance, including Infrequent Psychopathology Responses (ß = .33, p = .002). PTSD severity was associated with prescription opioid use when accounting for the effects of over-reported somatic and cognitive symptoms (odds ratio 1.05, p ≤ .025). Results highlight the role of symptom overreporting and perceptions of functional impairment to observable behaviors among individuals with chronic pain.

Centralizing Telehealth Test-to-Treat Through a Regional Clinical Contact Center: A Veterans Health Administration Pilot.

Background: This project describes a Veterans Health Administration telehealth pilot to facilitate COVID-19 oral antiviral treatment as part of the national test-to-treat (T2T) strategy. The pilot was operationalized for two pilot VA medical centers by the regional clinical contact center (CCC) for a Veteran Integrated Service Network, which offers multiple services through several virtual modalities. Methods: Nurse triage and medical provider evaluation templates were developed for the CCC to standardize clinical interventions with veteran callers reporting positive home COVID-19 test results. When veterans were determined eligible and consented to treatment with an emergency use authorization (EUA) antiviral medication, CCC providers used secure direct messaging for synchronous communication with local pharmacy services to facilitate adjudication and dispensing. Templates for pharmacy documentation and primary care follow-up monitoring were also developed and disseminated. Results: In total, 198 veterans (mean age 65 years, 89% male, 88% non-Hispanic White) were evaluated through telehealth by regional CCC providers using the T2T process and 96% were prescribed an antiviral medication. Primary care follow-up occurred in 86% of cases, a median of 3 days after the telehealth evaluation. The 30-day all-cause hospitalization rate was 1.5% and there were no deaths within 30 days of treatment initiation. Conclusions: Veterans Integrated Service Network's CCC telehealth triage and evaluation processes enabled safe EUA-compliant care delivery, improved evaluator experience and efficiency, and augmented existing EUA processes in place by front-line pharmacy and primary care teams.

A Phase II trial of weekly bortezomib and dexamethasone in veterans with newly diagnosed multiple myeloma not eligible for or who deferred autologous stem cell transplantation.

Once-weekly administration of bortezomib has reduced bortezomib-induced peripheral neuropathy without affecting response rates, but this has only been demonstrated prospectively in three- and four- drug combinations. We report a phase II trial of alternate dosing and schedule of bortezomib and dexamethasone in newly diagnosed multiple myeloma patients who are not eligible for or refused autologous stem cell transplantation. Bortezomib 1·6 mg/m(2) intravenously was given once-weekly for six cycles, together with dexamethasone 40 mg on the day of and day after bortezomib. Fifty patients were enrolled; 58% did not require any dose modification. The majority of patients had multiple co-morbidities, including cardiovascular (76%) and renal insufficiency (54%), and the median number of medications prior to enrollment was 13. Of all evaluable patients, the overall response rate was 79% and at least 45% had at least a very good partial response. The median time to first response was 1·3 months (range, 0·25-2·4 months). The progression-free and overall survivals were 8 months and 46·5 months, respectively. Twenty-four percent developed worsening neuropathy. We conclude that alternate dosing and scheduling of bortezomib and dexamethasone is both safe and effective for management of newly diagnosed multiple myeloma in frail patients. (ClinicalTrials.gov number, NCT01090921).

Prevention of bone loss and vertebral fractures in patients with chronic epilepsy--antiepileptic drug and osteoporosis prevention trial.

PURPOSE: To evaluate whether use of a bisphosphonate (risedronate) in addition to calcium and vitamin D in male veterans with epilepsy who were taking antiepileptic drugs (AEDs) long term can prevent the loss of bone mass (BMD, bone mineral density) associated with AED use compared to patients who were treated with a placebo plus calcium and vitamin D. As a secondary end point we studied the incidence of new morphometric vertebral and nonvertebral fractures. METHODS: Antiepileptic drug and osteoporosis prevention trial (ADOPT) was designed as a prospective 2-year double-blind, randomized placebo controlled study involving 80 male veterans with epilepsy who were being treated with AEDs such as phenytoin, phenobarbital, sodium valproate, or carbamazepine for a minimum of 2 years. All enrolled participants received calcium and vitamin D supplementation, and were randomized to risedronate or matching placebo. Total body, bilateral proximal femora, and anteroposterior (AP) lumbar spine BMDs in addition to morphometric lateral vertebral assessments (LVAs) were evaluated by a dual energy x-ray absorptiometry (DXA) instrument. Comparisons of BMDs were made between baseline, 1 year, and after 2 years of enrollment in the study. The incidence of new vertebral and nonvertebral fractures was secondary end point. KEY FINDINGS: Of the 80 patients initially enrolled in the study, 53 patients completed the study. Baseline characteristics of the two groups were similar. At the end of the study, in the placebo plus calcium and vitamin D group, we observed a significant improvement in BMD at any of the evaluated sites when compared to their baseline scans in 69% (18/26) of the participants. In the risedronate plus calcium and vitamin D group, we observed significant improvement of BMDs in 70% (19/27) of the participants. At the end of the study, the risedronate group experienced a significant increase of BMD at the lumbar spine L1-4 (1.267-1.332 g/cm(2)), which was significantly larger than that seen in the placebo group) (1.229 g/cm(2) vs. 1.245 g/cm(2) ; p = 0.0066).There were nonsignificant differences between the two groups regarding changes of total body BMD or at the proximal bilateral femora. Five new vertebral fractures and one nonvertebral fracture were observed only in the placebo group. SIGNIFICANCE: Calcium and vitamin D supplementation or calcium and vitamin D supplementation in addition to risedronate improved BMD in more than 69% of male veterans with epilepsy who were taking AEDs. In the group receiving risedronate plus calcium and vitamin D there was a significant improvement of BMD at the lumbar spine as compared to the placebo group, which also received calcium and vitamin D. The use of risedronate plus calcium and vitamin D prevented the incidence of new vertebral fractures and one nonvertebral fracture in this cohort.

Risk profile of hepatocellular carcinoma reveals dichotomy among US veterans.

BACKGROUND: Hepatocellular carcinoma (HCC) is traditionally associated with chronic liver injury resulting from hepatitis B virus (HBV) and hepatitis C virus (HCV) infection or excessive consumption of alcohol. In addition, recent evidence links HCC to diabetes. AIMS: Since these risk factors are prevalent among US veterans, we analyzedcontribution of various etiologies toHCC incidence in this population. METHODS: Clinicopathological correlates of 150 male US veterans diagnosed with HCC between 2001 and 2010 were analyzed and compared to frequency-matched (2:1) non-cancer controls in a single center. RESULTS: HCC was associated with cirrhosis (odds ratio [OR], 250.84; 95 % confidence interval [CI], 86.92-723.88; p < 0.0001), chronic hepatitis B (OR, 34.30 95 % CI, 1.97-598.47; p = 0.015), chronic hepatitis C (OR, 6.84; 95 % CI, 3.89-12.04; p < 0.0001), alcohol use (OR, 6.76; 95 % CI, 4.35-10.52; p < 0.0001), and smoking (OR, 1.83; 95 % CI, 1.23-2.89; p = 0.009), but surprisingly not with diabetes. Only in a subgroup of HCC patients with no "traditional" risk factors did diabetes become a strong independent predictor of HCC when compared to HCC patients with at least one such risk factor (OR, 10.69; 95 % CI, 1.88-60.63, p = 0.007). This subgroup was further distinguished by older age, increased prevalence of hypertension, nonsmoking, and a trend to develop noncirrhotic HCC. CONCLUSIONS: While HCC in US veterans is overwhelmingly linked to cirrhosis due to "traditional" risk factors, it also occurs with a separate clinical profile characterized by diabetes and no evidence of cirrhosis, suggesting distinct mechanisms of hepatocarcinogenesis and needs for surveillance.

Bevacizumab vs ranibizumab for age-related macular degeneration: early results of a prospective double-masked, randomized clinical trial.

PURPOSE: To report early outcomes of a prospective, double-masked, controlled trial comparing bevacizumab (Avastin; Genentech Inc, South San Francisco, California, USA) to ranibizumab (Lucentis; Genentech Inc) for the treatment of age-related macular degeneration. DESIGN: Prospective, double-masked, randomized clinical trial. METHODS: This is a single-center, randomized clinical trial at the Boston Veterans Affairs Healthcare System. Patients who met inclusion criteria were randomized 2:1 to bevacizumab or ranibizumab. Each patient contributed 1 eye to the study. All subjects and investigators (except for the pharmacist responsible for study assignments) were masked to treatment arms. Visual acuity (VA) was checked on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Patients were given either bevacizumab or ranibizumab every month for the first 3 months, followed by optical coherence tomography-guided, variable-dosing schedule. Main outcomes measured were VA and foveal thickness. RESULTS: Twenty patients completed the 6-month follow up. Thirteen patients received bevacizumab and 7 patients received ranibizumab. No subjects in either group lost more than 15 letters on ETDRS chart. The average preoperative VA was 31.6 letters in the bevacizumab group and 30.4 letters in the ranibizumab group. At 6 months follow-up, mean vision was 46.4 letters in the bevacizumab group and 37.4 letters in the ranibizumab group. Two-tailed ttest failed to show statistical significance between the two groups. Patients in the bevacizumab group underwent an average of 5 injections, while patients in the ranibizumab group underwent a mean of 4 injections. CONCLUSION: Early results of a head-to-head, randomized, double-masked, prospective, single-center controlled trial between bevacizumab and ranibizumab show no difference in efficacy between the two treatments for choroidal neovascularizaton in the treatment of age-related macular degeneration. As this study conveys results of a small number of patients, further studies with larger sample sizes are needed in order to establish statistical significance.

Reasons provided by prescribers when overriding drug-drug interaction alerts.

OBJECTIVES: To investigate prescribers' rationales for overriding drug-drug interaction (DDI) alerts and to determine whether these reasons were helpful to pharmacists as a part of prescription order verification. STUDY DESIGN: An observational retrospective database analysis was conducted using override reasons derived from a computerized system at 6 Veterans Affairs medical centers. METHODS: Data on DDI alerts (for interactions designated as "critical" and "significant") were obtained from ambulatory care pharmacy records from July 1, 2003, to June 30, 2004. Prescribers' reasons for overriding alerts were organized into 14 categories and were then rated as clinically useful or not to the pharmacist in the assessment of potential patient harm. RESULTS: Of 291,890 overrides identified, 72% were for critical DDIs. Across the Veterans Affairs medical centers, only 20% of the override reasons for critical DDI alerts were rated as clinically useful for order verification. Despite a mandatory override reason for critical DDI alerts, 53% of the responses were "no reason provided." The top response categories for critical and significant DDI alerts were "no reason provided," "patient has been taking combination," and "patient being monitored." CONCLUSIONS: When given the opportunity to provide a reason for overriding a DDI alert, prescribers rarely enter clinical justifications that are useful to order verification pharmacists. This brings into question how computerized physician order entry systems should be designed.

Practitioners' views on computerized drug-drug interaction alerts in the VA system.

OBJECTIVES: To assess Veterans Affairs (VA) prescribers' and pharmacists' opinions about computer-generated drug-drug interaction (DDI) alerts and obtain suggestions for improving DDI alerts. DESIGN: A mail survey of 725 prescribers and 142 pharmacists from seven VA medical centers across the United States. MEASUREMENTS: A questionnaire asked respondents about their sources of drug and DDI information, satisfaction with the combined inpatient and outpatient computerized prescriber order entry (CPOE) system, attitude toward DDI alerts, and suggestions for improving DDI alerts. RESULTS: The overall response rate was 40% (prescribers: 36%; pharmacists: 59%). Both prescribers and pharmacists indicated that the CPOE system had a neutral to positive impact on their jobs. DDI alerts were not viewed as a waste of time and the majority (61%) of prescribers felt that DDI alerts had increased their potential to prescribe safely. However, only 30% of prescribers felt DDI alerts provided them with what they needed most of the time. Both prescribers and pharmacists agreed that DDI alerts should be accompanied by management alternatives (73% and 82%, respectively) and more detailed information (65% and 89%, respectively). When asked about suggestions for improving DDI alerts, prescribers most preferred including management options whereas pharmacists most preferred making it more difficult to override lethal interactions. Prescribers and pharmacists reported primarily relying on electronic references for general drug information (62% and 55%, respectively) and DDI information (51% and 79%, respectively). CONCLUSION: Respondents reported neutral to positive views regarding the effect of CPOE on their jobs. Their opinions suggest DDI alerts are useful but still require additional work to increase their clinical utility.