Cheryl McCullumsmith

Patient Reported Outcomes in Routine Care: Advancing Data Capture for HIV Cohort Research

INTRODUCTION Computerized collection of standardized measures of patient reported outcomes (PROs) provides a novel paradigm for data capture at the point of clinical care. Comparisons between data from PROs and Electronic Health Records (EHR) are lacking. We compare EHR and PRO for capture of depression and substance abuse and their relationship to adherence to antiretroviral therapy (ART). METHODS This retrospective study includes HIV-positive patients at an HIV clinic who completed an initial PRO assessment April 2008-July 2009. The questionnaire includes measures of depression (PHQ-9) and substance abuse (ASSIST). Self-reported ART adherence was modeled using separate logistic regression analyses (EHR vs PRO). RESULTS The study included 782 participants. EHR vs PRO diagnosis of current substance abuse was 13% (n = 99) vs 6% (n = 45) (P < .0001), and current depression was 41% (n = 317) vs 12% (n = 97) (P < .0001). In the EHR model, neither substance abuse (OR = 1.25; 95% CI = 0.70-2.21) nor depression (OR = 0.93; 95% CI = 0.62-1.40) was significantly associated with poor ART adherence. Conversely, in the PRO model, current substance abuse (OR = 2.78; 95% CI = 1.33-5.81) and current depression (OR = 1.93; 95% CI = 1.12-3.33) were associated with poor ART adherence. DISCUSSIONS The explanatory characteristics of the PRO model correlated best with factors known to be associated with poor ART adherence (substance abuse; depression). The computerized capture of PROs as a part of routine clinical care may prove to be a complementary and potentially transformative health informatics technology for research and patient care.

Simulated Illness: The Factitious Disorders and Malingering

Consciously simulated illnesses fall into two diagnostic categories: factitious disorders and malingering, differentiated by both motivation for behavior and consciousness of that motivation. Factitious disorder behaviors are motivated by an unconscious need to assume the sick role, while malingering behaviors are driven consciously to achieve external secondary gains. Thus, factitious disorders are psychiatric disorders in the Diagnostic and Statistical Manual-IV text revision (DSM –IV TR), whereas malingering is listed as a condition not attributable to a mental illness. Diagnosis of factitious disorder depends first on detection of the conscious production of symptoms and then on delineation of the motivation behind the deception. This review will focus on the commonalities in detection of consciously simulated illnesses generally and on the difficulties in distinction between factitious disorder and malingering. The background and clinical presentations of factitious disorder and malingering have been extensively reviewed, and will not be extenively covered in this review. This review will discuss current controversies in iagnosis and recent research providing further insights into the detection of imulated illnesses, and end with a discussion of ethical and legal issues associated ith factitious disorder diagnoses.

Venlafaxine extended-release for depression following spinal cord injury a randomized clinical trial

IMPORTANCE Depression is prevalent and associated with negative outcomes in individuals with spinal cord injury (SCI). Antidepressants are used routinely to treat depression, yet no placebo-controlled trials have been published in this population to our knowledge. OBJECTIVE To determine the efficacy and tolerability of venlafaxine hydrochloride extended-release (XR) for major depressive disorder (MDD) or dysthymic disorder in persons with chronic SCI. DESIGN, SETTING, AND PARTICIPANTS Multisite, randomized (1:1), double-blind, placebo-controlled Project to Improve Symptoms and Mood After SCI (PRISMS) trial. All research staff conducting screening, intervention, and outcome procedures were blinded to randomization status. We screened 2536 patients from outpatient clinics at 6 SCI treatment centers in the United States and randomized 133 participants into the trial. Participants were 18 to 64 years old and at least 1 month after SCI, with MDD or dysthymic disorder. Seventy-four percent of participants were male, and participants were on average 40 years old and 11 years after SCI. Forty-seven percent had cervical injuries, 53.4% had American Spinal Injury Association injury severity A (complete injury) SCI, 24.1% had at least 2 prior MDD episodes, and 99.2% had current MDD. Common comorbidities included chronic pain (93.9%), significant anxiety (57.1%), and history of substance dependence (44.4%). INTERVENTIONS Twelve-week trial of venlafaxine XR vs placebo using a flexible-dose algorithm. MAIN OUTCOMES AND MEASURES The Hamilton Depression Rating Scale (HAM-D 17-item version and Maier subscale, which focuses on core depression symptoms and excludes somatic symptoms) over 12 weeks. RESULTS Mixed-effects models revealed a significant difference between the venlafaxine XR and placebo groups in improvement on the Maier subscale from baseline to 12 weeks (treatment effect, 1.6; 95% CI, 0.3-2.9; P = .02) but not on the HAM-D 17-item version (treatment effect, 1.0; 95% CI, -1.4 to 3.4; P = .42). Participants receiving venlafaxine XR reported significantly less SCI-related disability on the Sheehan Disability Scale at 12 weeks compared with placebo (treatment effect, 4.7; 95% CI, 1.5-7.8; P = .005). Blurred vision was the only significantly more common new or worsening adverse effect in the venlafaxine XR group compared with the placebo group over 12 weeks. CONCLUSIONS AND RELEVANCE Venlafaxine XR was well tolerated by most patients and an effective antidepressant for decreasing core symptoms of depression and improving SCI-related disability. Further research is needed to determine the optimal treatment and measurement approaches for depression in chronic SCI. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00592384.

Characteristics of Victims of Sexual Abuse by Gender and Race in a Community Corrections Population

The purpose of this study was to examine how victims of sexual abuse in a community corrections population differ as a result of their sex and race. Of the 19,422 participants, a total of 1,298 (6.7%) reported a history of sexual abuse and were compared with nonabused participants. The sample was analyzed by race–gender groups (White men, White women, African American men, and African American women) using univariate and logistic regression analyses, which were conducted separately for each group. White women were the most likely to report a history of sexual abuse (26.5%), followed by African American women (16.0%), White men (4.0%), and African American men (1.1%). For all groups, histories of suicidal ideation and suicide attempts were associated with a history of sexual abuse. Sexual abuse was associated with substance abuse problems for women but not the men. Cannabis dependence was associated with sexual abuse for the White women while cocaine dependence was associated with sexual abuse for the African American women. Several other variables were associated with sexual abuse for women but not men, including lower education (White women only), a history of violent offenses (White women only), and living in a shelter (African American women only). African American men tended to have higher levels of education; this was the only variable uniquely associated with either male group. Receiving psychiatric medications was associated with sexual abuse for all groups except African American men and a history of sex for drugs was associated with sexual abuse for all groups except White men. Consistent with national sample, women, particularly White women, were more likely to be victims of sexual abuse. The gender–race differences for the sociodemographic factors associated with sexual abuse, particularly the risk of substance abuse for women, suggest the need for tailored interventions for sexual abuse prevention and treatment.

Post-traumatic growth following spinal cord injury

Abstract Context/objective Examine the relationship of post-traumatic psychological growth (PTG), depression, and personal and injury characteristics in persons with spinal cord injury (SCI). Design Cross-sectional survey. Setting Community. Participants Eight hundred and twenty-four adults with SCI. Interventions None. Outcome measures Five items from the Post-traumatic Growth Inventory, reflecting positive change after injury in life priorities, closeness to others, new opportunities being available, stronger faith, and personal strength. Results Initial structural equation model testing of a conceptual model of personal and injury characteristics, violent etiology, depression, and PTG resulted in a poor fit. Model modifications resulted in an improved fit, but explained only 5% of the variance in PTG. Being female, younger, having less formal education, and less time since injury had significant relationships with PTG, whereas depression, violent etiology, and injury level/severity did not. In each PTG domain, between 54 and 79% of the sample reported at least some positive change after injury. Conclusions The results of this study, while promising, explained only a small portion of the variance in PTG. A majority of the sample experienced some positive change after injury, with the greatest change in discovering that they were stronger than they thought they were. Comparing means previously reported in a non-SCI sample of those who experienced trauma, positive change after injury was comparable for each PTG item except for new opportunities being available, which was significantly lower for those with SCI. Future directions of research include the development of theoretical models of PTG after SCI.

HIV-risk characteristics in community corrections.

Objective: Individuals in the criminal justice system engage in behaviors that put them at high risk for HIV. This study sought to identify characteristics of individuals who are under community corrections supervision (eg, probation) and at risk for HIV. Methods: Approximately 25,000 individuals under community corrections supervision were assessed for HIV risk, and 5059 participants were deemed high-risk or no-risk. Of those, 1519 exhibited high sexual-risk (SR) behaviors, 203 exhibited injection drug risk (IVR), 957 exhibited both types of risk (SIVR), and 2380 exhibited no risk. Sociodemographic characteristics and drug of choice were then examined using univariate and binary logistic regression. Results: Having a history of sexual abuse, not having insurance, and selecting any drug of choice were associated with all forms of HIV risk. However, the effect sizes associated with the various drugs of choice varied significantly by group. Aside from those common risk factors, very different patterns emerged. Female gender was a risk factor for the SR group but was less likely to be associated with IVR. Younger age was associated with SR, whereas older age was associated with IVR. Black race was a risk factor for SR but had a negative association with IVR and SIVR. Living in a shelter, living with relatives/friends, and being unemployed were all risk factors for IVR but were protective factors for SR. Conclusions: Distinct sociodemographic and substance use characteristics were associated with sexual versus injection drug use risk for individuals under community corrections supervision who were at risk for HIV. Information from this study could help identify high-risk individuals and allow tailoring of interventions.

Efficacy of venlafaxine XR for the treatment of pain in patients with spinal cord injury and major depression: a randomized, controlled trial.

OBJECTIVES To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain. DESIGN Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD. SETTING Six Departments of Physical Medicine and Rehabilitation in university-based medical schools. PARTICIPANTS Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain. INTERVENTION Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders. RESULTS The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites. CONCLUSIONS Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.

Gender and Racial Differences for Suicide Attempters and Ideators in a High-Risk Community Corrections Population

BACKGROUND Community corrections populations are a high-risk group who carry multiple suicide risk factors. AIMS To identify factors correlated with historical suicide attempts and ideation among African-American men, African-American women, White men, and White women in a community corrections population. METHOD Self-report data from 18,753 enrollees in community corrections were analyzed. Multinomial logistic regression analyses were conducted to determine associations between historical suicidal ideation and attempts among the four demographic groups. RESULTS Participants with historical suicide attempts tended to be younger, White, female, be taking psychotropic medication, have a history of physical or sexual abuse, and meet criteria for dependence on alcohol, amphetamines, cocaine, opioids, or sedatives. Five variables were commonly associated with suicide attempts for all four race/gender groups: younger age, being on disability or retirement, taking psychotropic medication, history of sexual or physical abuse, and cocaine dependence. Other demographic variables had race or gender specificities as risk factors for suicide attempts. CONCLUSIONS Participants had high rates of historical suicide attempts with unique correlates differentiating attempters from ideators among different racial and gender groups. Cocaine dependence was universal predictor of suicide attempts, while other substance dependencies show specific racial and gender profiles associated with suicide attempts.

Assessment of the relationship of spiritual well-being to depression and quality of life for persons with spinal cord injury

Abstract Objective: This study sought to describe the association between spiritual well-being, demographic characteristics, quality of life (QOL) and depressive symptoms following spinal cord injury (SCI). We hypothesized QOL and depressed mood would both be explained by extent of spiritual well-being, and meaning-focused (M&P) spirituality would have a stronger impact than faith-focused spirituality. Methods: 210 individuals with SCI were screened as part of a randomized control trial of venlafaxine XR for major depressive disorder (MDD). 204 completed all measures: Patient Health Questionniare-9 (PHQ-9) assessed depression, the FACIT-Sp assessed spiritual well-being, the Neuro-QOL PAWB scale assessed QOL, and the PANAS assessed affect. Results: Approximately 26% had major depression. Bivariate correlations of scores on PAWB and PANAS and FACIT-Sp showed that all four scales had strong associations with those on PAWB (p < 0.0005). As hypothesized, both the M&P and Faith scales of the FACIT-Sp were significant predictors of QOL (β = 0.544; p < 0.0005 and β = 0.151; p = 0.004), though only the M&P scale was an independently significant predictor of likely MDD. Conclusion: The findings support that spirituality, as measured by the FACIT-Sp, is strongly associated with QOL and likelihood of MDD. Assessment of spirituality should be included along with more traditional psychological measurements to better inform treatment. Implications for Rehabilitation Spiritual beliefs can contribute to quality of life and may help moderate depressive symptoms that accompany chronic illness and disability, suggesting that rehabilitation professionals should address spirituality in working with their patients with spinal cord injury (SCI). While spiritual issues are often deferred to pastoral counselors during hospitalization, it is clear that addressing these is not the domain of one discipline and does not end upon inpatient discharge. In addressing spirituality, clinicians should tap the spiritual strengths present in their clients, whether meaning/peace-focused or religious, understanding that spirituality involves more than religiosity and also that having a sense of meaning and peace appears to be of great importance.

Cigarette Smokers are Less Likely to Have Undetectable Viral Loads: Results From Four HIV Clinics.

Background:The prevalence of smoking among HIV-infected individuals is 2–3 times that of the general population, increasing the risk of smoking-related morbidity and mortality. We examined characteristics associated with smoking behavior among a large cohort of HIV-infected individuals in care in the United States. Methods:A convenience sample of 2952 HIV-infected patients in the Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) was assessed during routine clinic visits and was included. Multinomial logistic regression was used to examine the relationship between smoking status, depression/panic symptoms, alcohol/substance use, and demographic and clinical characteristics. Results:Compared with never-smokers, current smokers were more likely to have moderate to severe depression (odds ratio [OR] 1.37), endorse current substance use (OR 14.09), and less likely to report low-risk alcohol use on the Alcohol Use Disorders Identification Test (AUDIT-C) (OR 0.73). Current smokers were less likely to have an undetectable viral load (OR 0.75), and more likely to have current substance abuse (OR 2.81) and moderate to severe depression (OR 1.50), relative to smokers who had quit smoking. Conclusions:HIV-infected smokers are less likely to have undetectable viral loads and frequently have psychosocial comorbidities including depression and substance abuse that impact antiretroviral therapy adherence and viral load suppression. To be effective, smoking-cessation interventions need to address the complex underlying concurrent risks in this population.