Linda G. Marc

Factors influencing medication adherence beliefs and self-efficacy in persons naive to antiretroviral therapy: a multicenter, cross-sectional study.

It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Beliefs about antiretroviral therapy and psychosocial characteristics of HIV-positive persons naive to therapy may influence early experience with antiretroviral medication adherence and therefore could be important when designing programs to improve adherence to antiretroviral therapy. As part of a multicenter AIDS Clinical Trial Group (ACTG 384) study, 980 antiretroviral-naive subjects (82% male, 47% White, median age 36 years, and median CD4 cell count 278 cells/mm3) completed a self-administered questionnaire prior to random treatment assignment of initial antiretroviral medications. Measures of symptom distress, general health and well-being, and personal and situational factors including demographic characteristics, social support, self-efficacy, depression, stress, and current adherence to (nonantiretroviral) medications were recorded. Associations among variables were explored using correlation and regression analyses. Beliefs about the importance of antiretroviral adherence and ability to take antiretroviral medications as directed (adherence self-efficacy) were generally positive. Fifty-six percent of the participants were “extremely sure” of their ability to take all medications as directed and 48% were “extremely sure” that antiretroviral nonadherence would cause resistance, but only 37% were as sure that antiretroviral therapy would benefit their health. Less-positive beliefs about antiretroviral therapy adherence were associated with greater stress, depression, and symptom distress. More-positive beliefs about antiretroviral therapy adherence were associated with better scores on health perception, functional health, social–emotional–cognitive function, social support, role function, younger age, and higher education (r values = 0.09–0.24, all p < .001). Among the subset of 325 participants reporting current use of medications (nonantiretrovirals) during the prior month, depression was the strongest correlate of nonadherence (r = 0.33, p < .001). The most common reasons for nonadherence to the medications were “simply forgot” (33%), “away from home” (27%), and “busy” (26%). In conclusion, in a large, multicenter survey, personal and situational factors, such as depression, stress, and lower education, were associated with less certainty about the potential for antiretroviral therapy effectiveness and ones perceived ability to adhere to therapy. Findings from these analyses suggest a role for baseline screening for adherence predictors and focused interventions to address modifiable factors placing persons at high risk for poor adherence prior to antiretroviral treatment initiation

Screening Performance of the 15-Item Geriatric Depression Scale in a Diverse Elderly Home Care Population

OBJECTIVE To empirically evaluate the psychometric properties of the 15-item Geriatric Depression Scale (GDS-15); determine the optimal cutoff points and screening performance for the detection of major depression; and examine differential item functioning (DIF) to determine the variability of item responses across sociodemographics in an elderly home care population. DESIGN A secondary analysis of data collected from a random sample study. SETTING Homebound subjects newly admitted over a 2-year-period to a large visiting nurse service agency in Westchester, New York. PARTICIPANTS Five hundred twenty-six subjects over age 65, newly admitted to home care for skilled nursing. MEASUREMENTS Major depression was diagnosed using both patient, Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and best estimate procedures. Self-report measures included the GDS-15, activities of daily living (ADL), instrumental ADL, and pain intensity. Cognitive impairment was assessed using the Mini-Mental State Examination and medical morbidity using the Charlson Comorbidity Index. RESULTS Optimal cutoff (5) yielded sensitivity 71.8% and specificity of 78.2%, however, the accuracy of the GDS-15 was not influenced by severity of medical burden. Persons with a cluster of ailments were twice as likely (Adj odds ratio = 2.47; 95% confidence interval = 1.49-4.09) to be diagnosed with depression. DIF analyses revealed no variability of item responses across sociodemographics. CONCLUSION Main findings suggest that the accuracy of the GDS-15 was not influenced by severity of clinical or functional factors, or sociodemographics. This has broad implications suggesting that the very old, ill, and diverse populations can be appropriately screened for depression using the GDS-15.

HIV among Haitian-born persons in the United States, 1985–2007

Objective:Haitian-born persons have been historically stigmatized for introducing HIV to North America; however, no previous study has reported on the national HIV surveillance trends among this foreign-born group. Methods:Annual AIDS cases were estimated for adults and adolescents (aged >12 years) from all 50 US states and the District of Columbia who were diagnosed between 1985 and 2007, and who reported ‘Haiti’ as country of birth to the Centers for Disease Control and Prevention. HIV data (with or without AIDS) for Haitian-born adults and adolescents diagnosed between 2004 and 2007 were obtained from 34 US states. Denominators for AIDS rates by race/ethnicity are from postcensal estimates, the American Community Survey of the US Census Bureau and the Haitian Consulates. Results:In 2007, Haitian-born persons constituted 1.2% of US AIDS cases, yet accounted for 0.18% of the total US population based on the American Community Survey estimates, which suggests a seven-fold overrepresentation in the CDC AIDS surveillance data. However, when using population estimates from the Haitian Consulate, the overrepresentation ranges from three-to-four-fold, which is similar to the AIDS rate for blacks/African–Americans. Conclusion:The importance of having accurate denominators to estimate the AIDS rate for the Haitian population is paramount.

Psychometric evaluation of the HIV symptom distress scale

Abstract The objective of this article is to psychometrically validate the HIV symptom distress scale (SDS), an instrument that can be used to measure overall HIV symptom distress or clinically relevant groups of HIV symptoms. A secondary data analysis was conducted using the Collaborations in HIV Outcomes Research US Cohort (CHORUS). Inclusion criteria required study participants (N=5521) to have a valid baseline measure of the AIDS Clinical Trial Group Symptom Distress Module, with an SF-12 or SF-36 completed on the same day. Psychometric testing assessed unidimensionality, internal consistency, and factor structure using exploratory and confirmatory factor analysis, and structural equation modeling (SEM). Construct validity examined whether the new measure discriminates across clinical significance (CD4 and HIV viral load). Findings show that the SDS has high reliability (α=0.92), and SEM supports a correlated second-order factor model (physical and mental distress) with acceptable fit (GFI=0.88, AGFI=0.85, NFI=0.99, NNFI=0.99; RMSEA=0.06, [90% CI 0.06 – 0.06]; Satorra Bentler scaled, C 2 =3274.20; p=0.0). Construct validity shows significant differences across categories for HIV-1 viral load (p<0.001) and CD4 (p<0.001). Differences in mean SDS scores exist across gender (p<0.001), race/ethnicity (p<0.05), and educational attainment (p<0.001). Hence, the HIV SDS is a reliable and valid instrument, which measures overall HIV symptoms or clinically relevant groups of symptoms.

HIV+ caregivers and HIV+ non-caregivers: differences in sociodemographics, immune functioning, and quality-of-life.

Abstract Objective: To examine a cohort of HIV+ study participants, who are caregivers (CGs) and non-caregivers (NCGs), to determine whether differences exist across their sociodemographic backgrounds, immune functioning, and quality-of-life (i.e., symptom distress, physical, and mental quality-of-life). Methods: A secondary analysis of the cross-sectional subset of the population-based Collaborations HIV Outcomes Research US Cohort (CHORUS). Sample consists of 5521 HIV+ adults; median age 43 years (SD 8.7); 88.6% male; 70.7% non-Hispanic White, 17.6% African-American, and 7.8% Hispanic. Measures include the HIV Symptom Distress Scale and the SF-12. Analytical models included t-tests and multivariate linear regression. Results: HIV+ CGs have lower educational attainment than HIV+ NCGs (p=0.02). Seropositive CGs also experience greater HIV symptom distress (adjusted p<0.006) and poorer physical quality-of-life (adjusted p<0.001) than their seropostive NCG counterparts. Conclusion: HIV+ CGs may require different supportive services than HIV+ NCGs, suggesting a need to develop tailored interventions to address modifiable factors, such as lower education and poor physical health. Both of these factors have been associated with suboptimal antiretroviral adherence, suggesting a role for the routine screening of adherence predictors amongst HIV+ CGs. These findings may have more relevance in resource-poor settings where the prevalence of HIV is higher, with a likely growing population of informal and family CGs infected with HIV.

Sexual Dysfunction in Men With Inflammatory Bowel Disease: A New IBD-Specific Scale

Background Men with inflammatory bowel disease (IBD) may have increased sexual dysfunction. To measure the prevalence of sexual dysfunction in our male patients, we aimed to develop a new IBD-specific Male Sexual Dysfunction Scale (the IBD-MSDS). Methods We used a cross-sectional survey and enrolled male patients (N = 175) ≥18 years old who attended IBD clinics at 2 Boston hospitals. We collected information on sexual functioning via a 15-item scale. General male sexual functioning was measured using the International Index of Erectile Dysfunction (IIEF); the Patient Health Questionnaire (PHQ-9) measured depressive symptoms. Medical history and sociodemographic information were extracted from medical record review. Exploratory factor analyses (EFA) assessed unidimensionality, factor structure, reliability, and criterion and construct validity of the 15-item scale. We used regression models to identify clinical factors associated with sexual dysfunction. Results EFA suggested retaining 10-items generating a unidimensional scale with strong internal consistency reliability, α = 0.90. Criterion validity assessed using Spearmans coefficient showing that the IBD-MSDS was significantly correlated with all the subscales of the IIEF. The IBD-MSDS was significantly correlated (construct validity) with the PHQ-9 (P < 0.001) and the composite score for active IBD cases (P < 0.05). Male sexual dysfunction in IBD was significantly associated with the presence of an ileoanal pouch anastomosis (P = 0.047), depression (P < 0.001), and increased disease activity (P = 0.021). Conclusions We have developed and validated an IBD-specific scale to assess the psychosexual impact of IBD. This new survey tool may help physicians screen for and identify factors contributing to impaired sexual functioning in their male patients.

Implementing and Evaluating Computer-Assisted Coding of Adverse Events

Collecting and evaluating adverse events is an essential aspect of weighing the risk-benefit ratio of a drug. By providing a mechanism for classifying adverse events, dictionary coding is integral to evaluating safety data. In this paper, coding philosophy is discussed in terms of organizational structure (centralized versus decentralized) and level of automation (manual versus computer-assisted). Then a strategy for implementing a computer-assisted coding methodology that maximizes coding consistency and accuracy using the Astra Merck coding system as a case study is presented. Finally, techniques for evaluating and improving coding systems are described.

Automating Surveillance for the Analysis of Adverse Event Case Reports

The traditional method of manually reviewing large numbers of adverse event reports is not conducive to efficiently maintaining an up-to-date safety profile of a drug or to rapidly responding to inquiries on adverse events. The development of a computerized system was undertaken to perform the preliminary scrutiny of enormous quantities of information by evaluating the unique contents of each case report and quantifying the results. This paper will focus on how a computerized surveillance system identifies, in a patients record, concomitant drugs and preexisting medical conditions known to be associated with the adverse event under surveillance. The automated capability is not meant to replace the function of the expert medical reviewer but to assist in rapidly drawing attention to case reports that require further skilled review. Automating surveillance can improve the quality of AE review and also allow more efficient use of limited resources.

Development of a sexual dysfunction scale for women with inflammatory bowel disease

Background Women with inflammatory bowel disease (IBD) may have decreased sexual function. To understand how common this condition is in our female patients, we developed a new IBD-specific Female Sexual Dysfunction Scale (the IBD-FSDS). Methods We performed a prospective cross-sectional study of 454 female IBD patients ≥18 years of age attending 1 of 3 IBD clinics in the United States or Denmark. We gathered information on sexual function via a de novo 23-item scale. General sexual functioning was measured with the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). Depressive symptoms were measured with the Patient Health Questionnaire-9 (PHQ-9). Medical history and sociodemographic data were collected via chart review. Exploratory factor analyses (EFAs) of the English language version of IBD-FSDS assessed unidimensionality, factor structure, reliability, criterion validity, and construct validity. Results EFAs suggested retaining 15-items creating a unidimensional scale with strong internal consistency reliability (α = 0.93). Validity of the English language IBD-FSDS was measured using Spearmans coefficient, demonstrating significant criterion validity with the FSDS-R (P < 0.05) and the FSFI (P < 0.05) and significant construct validity with the composite for cases of active IBD (P < 0.05) and PHQ-9 (P < 0.05). Sexual dysfunction in women with IBD was significantly associated with depression (P = 0.042), active IBD (P = 0.002), and no history of surgery (P = 0.044). Conclusions We have developed and validated an IBD-specific scale to assess the psychosexual impact of IBD in women. This novel screening questionnaire may help health care providers recognize factors contributing to impaired sexual function in their female patients.