Eugenia Buta

Trauma, Social Support, Family Conflict, and Chronic Pain in Recent Service Veterans: Does Gender Matter?

OBJECTIVE Women veterans have a higher prevalence of chronic pain relative to men. One hypothesis is that differential combat and traumatic sexual experiences and attenuated levels of social support between men and women may differentially contribute to the development and perpetuation of pain. This investigation examined [1] gender differences in trauma, social support, and family conflict among veterans with chronic pain, and [2] whether trauma, social support, and family conflict were differentially associated with pain severity, pain interference, and depressive symptom severity as a function of gender. METHODS Participants included 460 veterans (56% female) who served in support of recent conflicts, and who endorsed pain lasting 3 months or longer. Participants completed a baseline survey during participation in a longitudinal investigation. Self-report measures included pain severity, pain interference, depressive symptom severity, exposure to traumatic life events, emotional and tangible support, and family conflict. RESULTS Relative to men, women veterans reporting chronic pain evidenced higher rates of childhood interpersonal trauma (51% vs 34%; P < 0.001) and military sexual trauma (54% vs 3%; P < 0.001), along with lower levels of combat exposure (10.00 vs 16.85, P < 0.001). Gender was found to be a moderator of the association of marital status, combat exposure, childhood interpersonal trauma, and family conflict with pain interference. It also moderated family conflict in the prediction of depressive symptoms. CONCLUSIONS Results underscore the potential importance of developing and testing gender specific models of chronic pain that consider the relative roles of trauma, social support, and family conflict.

Interactive voice response-based self-management for chronic back Pain: The Copes noninferiority randomized trial

Importance Recommendations for chronic pain treatment emphasize multimodal approaches, including nonpharmacologic interventions to enhance self-management. Cognitive behavioral therapy (CBT) is an evidence-based treatment that facilitates management of chronic pain and improves outcomes, but access barriers persist. Cognitive behavioral therapy delivery assisted by health technology can obviate the need for in-person visits, but the effectiveness of this alternative to standard therapy is unknown. The Cooperative Pain Education and Self-management (COPES) trial was a randomized, noninferiority trial comparing IVR-CBT to in-person CBT for patients with chronic back pain. Objective To assess the efficacy of interactive voice response–based CBT (IVR-CBT) relative to in-person CBT for chronic back pain. Design, Setting, and Participants We conducted a noninferiority randomized trial in 1 Department of Veterans Affairs (VA) health care system. A total of 125 patients with chronic back pain were equally allocated to IVR-CBT (n = 62) or in-person CBT (n = 63). Interventions Patients treated with IVR-CBT received a self-help manual and weekly prerecorded therapist feedback based on their IVR-reported activity, coping skill practice, and pain outcomes. In-person CBT included weekly, individual CBT sessions with a therapist. Participants in both conditions received IVR monitoring of pain, sleep, activity levels, and pain coping skill practice during treatment. Main Outcomes and Measures The primary outcome was change from baseline to 3 months in unblinded patient report of average pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes included changes in pain-related interference, physical and emotional functioning, sleep quality, and quality of life at 3, 6, and 9 months. We also examined treatment retention. Results Of the 125 patients (97 men, 28 women; mean [SD] age, 57.9 [11.6] years), the adjusted average reduction in NRS with IVR-CBT (−0.77) was similar to in-person CBT (−0.84), with the 95% CI for the difference between groups (−0.67 to 0.80) falling below the prespecified noninferiority margin of 1 indicating IVR-CBT is noninferior. Fifty-four patients randomized to IVR-CBT and 50 randomized to in-person CBT were included in the analysis of the primary outcome. Statistically significant improvements in physical functioning, sleep quality, and physical quality of life at 3 months relative to baseline occurred in both treatments, with no advantage for either treatment. Treatment dropout was lower in IVR-CBT with patients completing on average 2.3 (95% CI, 1.0-3.6) more sessions. Conclusions and Relevance IVR-CBT is a low-burden alternative that can increase access to CBT for chronic pain and shows promise as a nonpharmacologic treatment option for chronic pain, with outcomes that are not inferior to in-person CBT. Trial Registration clinicaltrials.gov Identifier: NCT01025752

Risk for Incident Hypertension Associated With Posttraumatic Stress Disorder in Military Veterans and the Effect of Posttraumatic Stress Disorder Treatment

Objective Posttraumatic stress disorder (PTSD) increases cardiovascular disease and cardiovascular mortality risk. Neither the prospective relationship of PTSD to incident hypertension risk nor the effect of PTSD treatment on hypertension risk has been established. Methods Data from a nationally representative sample of 194,319 veterans were drawn from the Veterans Administration (VA) roster of United States service men and women. This included veterans whose end of last deployment was from September 2001 to July 2010 and whose first VA medical visit was from October 1, 2001 to January 1, 2009. Incident hypertension was modeled as 3 events: (1) a new diagnosis of hypertension and/or (2) a new prescription for antihypertensive medication, and/or (3) a clinic blood pressure reading in the hypertensive range (≥140/90 mm Hg, systolic/diastolic). Posttraumatic stress disorder diagnosis was the main predictor. Posttraumatic stress disorder treatment was defined as (1) at least 8 individual psychotherapy sessions of 50 minutes or longer during any consecutive 6 months and/or (2) a prescription for selective serotonin reuptake inhibitor medication. Results Over a median 2.4-year follow-up, the incident hypertension risk independently associated with PTSD ranged from hazard ratio (HR), 1.12 (95% confidence interval [CI], 1.08–1.17; p < .0001) to HR, 1.30 (95% CI, 1.26–1.34; p < .0001). The interaction of PTSD and treatment revealed that treatment reduced the PTSD-associated hypertension risk (e.g., from HR, 1.44 [95% CI, 1.38–1.50; p < .0001] for those untreated, to HR, 1.20 [95% CI, 1.15–1.25; p < .0001] for those treated). Conclusions These results indicate that reducing the long-term health impact of PTSD and the associated costs may require very early surveillance and treatment.

Psychometric properties of a MOVE!23 subscale: Perceived Contributors to Weight Change in a national sample of veterans.

The MOVE!23, a questionnaire to assess weight-related domains in veterans, was examined. Factor analysis of Perceived Contributors to Weight Change revealed three factors (psychosocial, eating behavior, and medical) that were positively correlated with body mass index, and psychiatric and medical comorbidity (p’s < 0.001). Multivariable cumulative logit models modeling the factor scores indicated that women were more likely than men to endorse psychosocial (odds ratio = 2.15, confidence interval = 2.04–2.27) and medical (odds ratio = 1.69, confidence interval = 1.59–1.79) items. The MOVE!23 Perceived Contributors to Weight Change subscale is a reliable and valid measure that is associated with body mass index and may assist in tailoring treatments according to gender and comorbidity.

Methodological Considerations When Studying the Association between Patient‐Reported Care Experiences and Mortality

OBJECTIVE To illustrate methodological considerations when assessing the relationship between patient care experiences and mortality. DATA SOURCE Medical Expenditure Panel Survey data (2000-2005) linked to National Health Interview Survey and National Death Index mortality data through December 31, 2006. STUDY DESIGN We estimated Cox proportional hazards models with mortality as the dependent variable and patient experience measures as independent variables and assessed consistency of experiences over time. DATA EXTRACTION METHODS We used data from respondents age 18 or older with at least one doctors office or clinic visit during the year prior to the round 2 interview. We excluded subjects who died in the baseline year. PRINCIPAL FINDINGS The association between overall care experiences and mortality was significant for deaths not amenable to medical care and all-cause mortality, but not for amenable deaths. More than half of respondents were in a different care experience quartile over a 1-year period. In the five individual experience questions we analyzed, only time spent with the patient was significantly associated with mortality. CONCLUSIONS Deaths not amenable to medical care and the time-varying and multifaceted nature of patient care experience are important issues to consider when assessing the relationship between care experience and mortality.

Examining Gender as a Correlate of Self-Reported Pain Treatment Use Among Recent Service Veterans with Deployment-Related Musculoskeletal Disorders

Objective Women veterans with chronic pain utilize health care with greater frequency than their male counterparts. However, little is known about gender differences in the use of specialty pain care in this population. This investigation examined gender differences in self-reported use of opioids, interventional pain treatments, rehabilitation therapies, and complementary and integrative health (CIH) services for chronic pain treatment both within and outside of the Veterans Health Administration in a sample of veterans who served in support of recent conflicts. Methods Participants included 325 veterans (54% women) who completed a baseline survey as part of the Women Veterans Cohort Study and reported deployment-related musculoskeletal conditions and chronic pain. Measures included self-reported use of pain treatment modalities, pain severity, self-rated health, access to specialty care, disability status, and presence of a mental health condition. Results Men were more likely to report a persistent deployment-related musculoskeletal condition but were no more likely than women to report chronic pain. Overall, 21% of the sample reported using opioids, 27% used interventional strategies, 59% used rehabilitation therapies, and 57% used CIH services. No significant gender differences in use of any pain treatment modality were observed. Conclusions Use of pain specialty services was common among men and women, particularly rehabilitative and CIH services. There were no gender differences in the self-reported use of different modalities. These results are inconsistent with documented gender differences in pain care. They encourage further examination of gender differences in preferences and other individual difference variables as predictors of specialty pain care utilization.

Studying the interactive effects of menthol and nicotine among youth: An examination using e-cigarettes

BACKGROUND Tobacco products containing menthol are widely used by youth. We used e-cigarettes to conduct an experimental evaluation of the independent and interactive effects of menthol and nicotine among youth. PROCEDURES Pilot chemosensory experiments with fourteen e-cigarette users identified low (barely perceptible, 0.5%) and high (similar to commercial e-liquid, 3.5%) menthol concentrations. Sixty e-cigarette users were randomized to a nicotine concentration (0mg/ml, 6mg/ml, 12mg/ml) and participated in 3 laboratory sessions. During each session, they received their assigned nicotine concentration, along with one of three menthol concentrations in random counterbalanced order across sessions (0, 0.5%, 3.5%), and participated in three fixed-dose, and an ad-lib, puffing period. Urinary menthol glucuronide and salivary nicotine levels validated menthol and nicotine exposure. We examined changes in e-cigarette liking/wanting and taste, coolness, stimulant effects, nicotine withdrawal and ad-lib use. RESULTS Overall, the high concentration of menthol (3.5%) significantly increased e-cigarette liking/wanting relative to no menthol (p<0.001); there was marginal evidence of nicotine* menthol interactions (p=0.06), with an increase in liking/wanting when 3.5% menthol was combined with 12mg/ml nicotine, but not 6mg/ml nicotine. Importantly, both 0.5% and 3.5% menthol concentrations significantly improved taste and increased coolness. We did not observe nicotine or menthol-related changes in stimulant effects, nicotine withdrawal symptoms or ad-lib use. CONCLUSIONS Menthol, even at very low doses, alters the appeal of e-cigarettes among youth. Further, menthol enhances positive rewarding effects of high nicotine-containing e-cigarettes among youth.

Biochemical, demographic, and self-reported tobacco-related predictors of the acute heart rate response to nicotine in smokers.

ABSTRACT Understanding the stimulatory effects of nicotine on cardiovascular function in humans is of great interest given the wide‐spread use of different forms of combustible and smokeless products that deliver nicotine. An intravenous nicotine infusion procedure was used to evaluate factors associated with the acute heart rate (HR) response to nicotine (0.5 mg per 70 kg bodyweight) in a sample of 213 smokers. We tested for differential response to nicotine based on demographic characteristics (race [European American vs African America], sex, body mass index and age); a set of blood‐based biomarkers (baseline nicotine, cotinine and cortisol levels and nicotine metabolite ratio); and a set of self‐reported measures related to tobacco use. Nicotine infusion was first noted to increase HR approximately 10 beats per minute (95% CI: 7.8–12.3) one minute post‐infusion, and 13 beats per minute (95% CI: 11.0–15.2) two minutes post‐infusion. Higher cortisol, lower nicotine levels, higher nicotine metabolite ratio, being female and greater withdrawal symptoms were independently associated with a potentiated increase in HR 1 or 2 min after nicotine infusion. Factors associated with the acute HR effects of nicotine warrant further investigation given their potential to inform the development of nicotine delivery systems as tobacco harm reduction approaches for smokers. HighlightsIntravenous nicotine increased heart rate 10–13 beats per minute within 2 min.Cortisol, nicotine and nicotine metabolite ratio were associated with HR response.Females had a potentiated HR response to nicotine.Withdrawal symptoms were positively correlated with HR response.

Models for analyzing zero-inflated and overdispersed count data: an application to cigarette and marijuana use.

Introduction This paper describes different methods for analyzing counts and illustrates their use on cigarette and marijuana smoking data. Methods The Poisson, zero-inflated Poisson (ZIP), hurdle Poisson (HUP), negative binomial (NB), zero-inflated negative binomial (ZINB) and hurdle negative binomial (HUNB) regression models are considered. The different approaches are evaluated in terms of the ability to take into account zero-inflation (extra zeroes) and overdispersion (variance larger than expected) in count outcomes, with emphasis placed on model fit, interpretation, and choosing an appropriate model given the nature of the data. The illustrative data example focuses on cigarette and marijuana smoking reports from a study on smoking habits among youth e-cigarette users with gender, age, and e-cigarette use included as predictors. Results Of the 69 subjects available for analysis, 36% and 64% reported smoking no cigarettes and no marijuana, respectively, suggesting both outcomes might be zero-inflated. Both outcomes were also overdispersed with large positive skew. The ZINB and HUNB models fit the cigarette counts best. According to goodness-of-fit statistics, the NB, HUNB, and ZINB models fit the marijuana data well, but the ZINB provided better interpretation. Conclusion In the absence of zero-inflation, the NB model fits smoking data well, which is typically overdispersed. In the presence of zero-inflation, the ZINB or HUNB model is recommended to account for additional heterogeneity. In addition to model fit and interpretability, choosing between a zero-inflated or hurdle model should ultimately depend on the assumptions regarding the zeros, study design, and the research question being asked. Implications Count outcomes are frequent in tobacco research and often have many zeros and exhibit large variance and skew. Analyzing such data based on methods requiring a normally distributed outcome are inappropriate and will likely produce spurious results. This study compares and contrasts appropriate methods for analyzing count data, specifically those with an over-abundance of zeros, and illustrates their use on cigarette and marijuana smoking data. Recommendations are provided.

Discontinuing a non-steroidal anti-inflammatory drug (NSAID) in patients with knee osteoarthritis: Design and protocol of a placebo-controlled, noninferiority, randomized withdrawal trial

BACKGROUND Knee osteoarthritis (OA) is the most common cause of knee pain in older adults. Despite the limited data supporting their use, non-steroidal anti-inflammatory drugs (NSAID) are among the most commonly prescribed medications for knee OA. The use of NSAIDs for knee pain warrants careful examination because of toxicity associated with this class of medications. METHODS We describe the design of a placebo-controlled, noninferiority, randomized withdrawal trial to examine discontinuation of an NSAID in patients with painful knee OA. Participants will be veterans enrolled in the VA Healthcare System with knee OA pain despite NSAID use and/or relatively higher risk of NSAID toxicity. After a two-week run-in period where eligible subjects will replace their current NSAID with the study NSAID (meloxicam), those remaining eligible (target N=544) will be randomized to receive four weeks of either placebo or continued meloxicam. The primary outcome is knee pain (Western Ontario and McMaster Universities Osteoarthritis Index pain subscale, range 0-20) at four weeks post-randomization. The primary hypothesis is that placebo will be noninferior to (that is, not much worse than) meloxicam within a noninferiority margin of 1. Secondary outcomes include lower extremity disability, global impression of change, adherence to study medication and use of co-therapies. DISCUSSION This study is the first clinical trial to date examining the effects of withdrawing an NSAID for OA knee pain. If successful, this trial will provide evidence against the continued use of NSAIDs in patients with OA knee pain. TRIAL REGISTRATION ClinicalTrials.gov: NCT01799213. Registered February 22, 2013.