Comparative Responsiveness and Minimally Important Difference of Common Anxiety Measures.

BACKGROUND: Anxiety is one of the most prevalent mental disorders and accounts for substantial disability as well as increased health care costs. This study examines the minimally important difference (MID) and responsiveness of 6 commonly used anxiety scales. METHODS: The sample comprised 294 patients from 6 primary care clinics in a single VA medical center who were enrolled in a telecare trial for treatment of chronic musculoskeletal pain and comorbid depression and/or anxiety. The measures assessed were the Patient Reported Outcomes Measurement Information System (PROMIS) 4-item, 6-item, and 8-item anxiety scales; the Generalized Anxiety Disorder 7-item scale (GAD-7); the Symptom Checklist anxiety subscale (SCL); the Posttraumatic Stress Disorder Checklist (PCL); the Short Form (SF)-36 Mental Health subscale; and the SF-12 Mental Component Summary (MCS). Validity was assessed with correlations of these measures with one another and with measures of quality of life and disability. MID was estimated by triangulating several methods. Responsiveness was evaluated by comparing: (a) the standardized response means for patients who reported their mood as being better, the same, or worse at 3 months; (b) the area under the curve for patients who had improved (better) versus those who had not (same/worse). RESULTS: Convergent and construct validity was supported by strong correlations of the anxiety measures with one another and moderate correlations with quality of life and disability measures, respectively. All measures differentiated patients who reported global improvement at 3 months from those who were unchanged, but were less able to distinguish worsening from no change. The area under the curves showed comparable responsiveness of the scales. The estimated MID was 4 for the PROMIS scales; 3 for the GAD-7; 6 for the PCL; 9 for the SF-36 mental health subscale; 5 for the MCS score, and 0.3 for the SCL anxiety scale. CONCLUSIONS: Six commonly used anxiety scales demonstrate similar responsiveness, and estimated MIDs can be used to gauge anxiety change in clinical research and practice.

Automated Self-management (ASM) vs. ASM-Enhanced Collaborative Care for Chronic Pain and Mood Symptoms: the CAMMPS Randomized Clinical Trial.

BACKGROUND: Chronic musculoskeletal pain is often accompanied by depression or anxiety wherein co-occurring pain and mood symptoms can be more difficult to treat than either alone. However, few clinical trials have examined interventions that simultaneously target both pain and mood conditions. OBJECTIVE: To determine the comparative effectiveness of automated self-management (ASM) vs. ASM-enhanced collaborative care. DESIGN: Randomized clinical trial conducted in six primary care clinics in a VA medical center. PARTICIPANTS: Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms. INTERVENTION: ASM consisted of automated monitoring and 9 web-based self-management modules. Comprehensive symptom management (CSM) combined ASM with collaborative care management by a nurse-physician team. Both interventions were delivered for 12 months. MAIN MEASURES: Primary outcome was a composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores: 0.2, 0.5, and 0.8 represent potentially small, moderate, and large clinical differences. Secondary outcomes included global improvement, health-related quality of life, treatment satisfaction, and health services use. KEY RESULTS: Both CSM and ASM groups had moderate PAD score improvement at 12 months (z = - 0.65 and - 0.52, respectively). Compared to the ASM group, the CSM group had a - 0.23 (95% CI, - 0.38 to - 0.08; overall P = .003) greater decline in composite PAD z-score over 12 months. CSM patients were also more likely to report global improvement and less likely to report worsening at 6 (P = .004) and 12 months (P = .013). CONCLUSIONS: Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms. However, the model combining collaborative care led by a nurse-physician team with web-based self-management was superior to self-management alone. TRIAL REGISTRATION: ClinicalTrials.gov : NCT0175730.

Comparative validity and responsiveness of PHQ-ADS and other composite anxiety-depression measures.

BACKGROUND: Composite measures that assess the overall burden of anxiety and depressive symptoms have been infrequently evaluated in the same study. The objective of this study was to compare the validity and responsiveness of the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) and other composite anxiety-depression measures. METHODS: The sample comprised 256 primary care patients enrolled in a telecare trial of chronic musculoskeletal pain and comorbid depression and/or anxiety. Measures included the PHQ-ADS; the 8-item and 4-item depression and anxiety scales from the PROMIS profiles; the PHQ-anxiety-depression scale (PHQ-4); the SF-36 Mental Health scale; and the SF-12 Mental Component Summary scale. Correlations among these measures and health-related quality of life measures were examined. Responsiveness was evaluated by standardized response means, area under the curve (AUC) analyses, and treatment effect sizes in the trial. RESULTS: Convergent and construct validity was supported by strong correlations of the composite depression-anxiety measures with one another and moderate correlations with health-related quality of life measures, respectively. All composite measures differentiated patients who were better at 3 months, whereas the PHQ-ADS and PHQ-4 also distinguished the subgroup that had worsened. AUCs for composite measures were generally similar, whereas treatment effect sizes were largest for the PHQ-ADS. LIMITATIONS: The study sample was predominantly male veterans enrolled from primary care who had chronic musculoskeletal pain and moderate levels of depression and anxiety. CONCLUSIONS: Composite depression and anxiety scales are valid and responsive measures that may be useful as outcomes in research and clinical practice.

Clinical Characteristics and Outcomes of Mild to Moderate Alcoholic Hepatitis.

INTRODUCTION & AIM: Much is known about alcoholic hepatitis (AH) that is severe enough to require hospitalization. The characteristics of individuals with alcoholic hepatitis presenting with mild to moderate severity are not well understood. In this study we investigated the risk factors, characteristics, and outcomes of mild to moderate AH. METHODS: Two hundred and fifty five Individuals with AH enrolled into a multicenter, prospective, observational study between 12/2014 and 4/2018 were included. Participants were seen at enrollment, 6 months, and 12 months. Mild to moderate AH (M-AH) was defined as MELD ≤ 20 at presentation whereas severe AH as MELD ≥ 21. RESULTS: One hundred individuals had M-AH whereas 155 had severe AH. Individuals with M-AH were older (49 vs 44 years, p=0.01), had lower BMI (27 vs 31 kg/m2, p=0.0007) and more likely to be male (68% vs 55%, p=0.046) compared to severe AH group. A higher proportion in M-AH group consumed coffee in the last 5 years compared to the severe AH (29% vs 18%, p=0.03), and fewer had PNPLA3 risk allele G (p=0.019) compared to the severe AH group. Average drinks per drinking day (12.9 vs 10.7, p=0.13) and total number of drinks in last 30 day period (331 vs 280, p=0.14) were not different between two groups. Compared to severe AH, patients with M-AH had significantly lower mortality at 30 days (2% vs. 13.6%), 90 days (3% vs. 22.6%), and 12 months (10.4% vs. 31.4%) (p <0.001 for all). CONCLUSIONS: Individuals with mild to moderate AH were older, less obese, drank coffee more often and carried more favorable PNPLA3 genotype compared to severe AH, despite similar alcohol consumption. Mild to moderate AH had substantial mortality with one in ten dying by 12 months. (Word Count 286).

Posttraumatic Stress Disorder in Patients with Heavy Alcohol Consumption and Alcoholic Hepatitis.

BACKGROUND: Lifetime prevalence of posttraumatic stress disorder (PTSD) in the general population is reported to be 6.8%. Individuals with alcohol dependence and substance abuse have high prevalence of PTSD. However, the prevalence of PTSD in heavy drinkers with alcoholic hepatitis (AH) is not known.The study's aim was to determine the prevalence of PTSD in heavy drinkers with and without AH. METHODS: We screened for PTSD using the Primary Care-PTSD questionnaire among heavy drinkers with (n = 115) and without (n = 64) AH participating in a multicenter observational study in which participants were followed up to 12 months following their enrollment. RESULTS: The prevalence of PTSD in heavy drinkers with AH was 34% and was not different from heavy drinking controls without liver disease (34%). In the entire group screened for PTSD, the presence of PTSD was associated with higher alcohol consumption as reported by average drinks per last 30 days and average grams of alcohol consumed per day (p = 0.047 for both tests), but not associated with relapse of heavy drinking or mortality. Similarly, patients with AH and PTSD did not have higher relapse rate or higher mortality compared to patients with AH but no PTSD. CONCLUSIONS: Compared to previously reported prevalence in general population, heavy drinking individuals with or without AH have significantly higher prevalence of PTSD. However, PTSD was not associated with higher relapse rate or higher mortality in this population.

What predicts medication therapy management completion rates? The role of community pharmacy staff characteristics and beliefs about medication therapy management.

OBJECTIVES: To model the association between pharmacy technicians' attitudes and planned behaviors toward participating in medication therapy management (MTM) and MTM completion rates. Secondary objectives included 1) to compare pharmacy technician and pharmacist attitudes and planned behaviors toward participating in MTM and 2) to identify respondent and pharmacy demographic factors associated with MTM completion rates. DESIGN: A 27-item survey, adapted from a previously published survey tool based on the Theory of Planned Behavior (TPB), was used to collect respondent perceptions of MTM. Study procedures were approved by the institutional review board. SETTING AND PARTICIPANTS: Pharmacy technicians and pharmacists representing 116 Midwestern community pharmacy locations within a national supermarket chain were eligible to complete a telephone survey during February to May 2017. MAIN OUTCOME MEASURES: MTM completion rates were recorded during the 6-month time frame before survey administration. Unique, nonmeaningful survey codes were used to link responses from respondents to their store's MTM completion rates. Multivariate linear regression analysis was used to model the association between survey responses, pharmacy and staff demographics, and MTM completion rates. RESULTS: Of the 116 eligible pharmacy technicians and 114 pharmacists, 77 pharmacy technicians and 99 pharmacists completed the survey yielding response rates of 66.4% and 86.8%, respectively. Pharmacy technicians held significantly more positive perceptions about MTM delivery, particularly regarding adequate time and support. However, pharmacy technicians reported having the necessary knowledge and skills significantly less frequently compared with pharmacists. TPB variables for pharmacy technicians were not significant predictors of MTM completion rates. However, pharmacist attitudes, pharmacy technician education, and number of technician hours worked per week were positively associated with MTM completion rates. CONCLUSION: Pharmacists' attitudes, pharmacy technician level of education, and number of technician hours worked per week were associated with MTM completion rates.

Interaction between the patatin-like phospholipase domain-containing protein 3 genotype and coffee drinking and the risk for acute alcoholic hepatitis.

Only a subset of subjects with excessive alcohol consumption develops alcoholic liver disease (ALD). One of the major risk factors for ALD is the genetic variant of the patatin-like phospholipase domain-containing protein 3 (PNPLA3) gene. Coffee is one of the most commonly consumed beverages, and coffee consumption has been associated with lower levels of serum alanine aminotransferase. The aim of this study was to investigate the role of coffee drinking and PNPLA3 rs738409 and their association with alcoholic hepatitis (AH) in a well-characterized cohort of subjects from the Translational Research and Evolving Alcoholic Hepatitis Treatment consortium. AH subjects and heavy drinking controls without a history of liver disease who were enrolled between May 2013 and May 2016 were included (n = 339), and the details of alcohol and coffee consumption were assessed. The PNPLA3 variant was determined among participants of European ancestry (n = 183). Relationships between baseline data and AH status were determined, and multivariable logistic regression modeling was performed. During the study period, 189 cases with AH and 150 heavy drinking controls were prospectively enrolled. The prevalence of regular coffee consumption was significantly lower in patients with AH compared to controls (20% versus 43%; P < 0.0001). The overall minor allele frequency of the PNPLA3 variant was higher in AH cases. Multivariable logistic regression revealed that coffee consumption and PNPLA3 were significantly associated with AH status at baseline after adjusting for relevant patient characteristics. Conclusion: We found a higher prevalence of AH among heavy drinkers with PNPLA3 G/G and G/C genotypes regardless of coffee consumption status and a higher prevalence of AH among heavy drinkers who were not regular coffee drinkers. These findings remained after considering relevant baseline patient characteristics. Further studies are needed to confirm our observation. (Hepatology Communications 2018;2:29-34).

Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial: Study design and sample characteristics.

BACKGROUND: Pain is the most common presenting somatic symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. They frequently co-occur, are under-treated, and result in substantial disability and reduced health-related quality of life. OBJECTIVES: The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource technology-assisted intervention for the management of patients suffering from pain plus anxiety and/or depression. METHODS/DESIGN: CAMMPS has enrolled 294 primary care patients with chronic pain plus comorbid anxiety and/or depression and randomized them to either: 1) Assisted Symptom Management (ASM) consisting of automated symptom monitoring by interactive voice recording or Internet and prompted pain and mood self-management; or 2) Comprehensive Symptom Management (CSM) which combines ASM with optimized medication management delivered by a nurse-physician specialist team and facilitated mental health care. Outcomes are assessed at baseline, 1, 3, 6, and 12months. The primary outcome is a composite pain-anxiety-depression (PAD) severity score. Secondary outcomes include individual pain, anxiety, and depression scores, health-related quality of life, disability, healthcare utilization, and treatment satisfaction. DISCUSSION: CAMMPS provides an integrated approach to PAD symptoms rather than fragmented care of single symptoms; coordinated symptom management in partnership with primary care clinicians and psychologists embedded in primary care; efficient use of health information technology; attention to physical and psychological symptom comorbidity; and the coupling of self-management with optimized medication management and facilitated mental health care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01757301.

Movement sequencing in Huntington disease.

OBJECTIVES: To examine longitudinal changes in movement sequencing in prodromal Huntington's disease (HD) participants (795 prodromal HD; 225 controls) from the PREDICT-HD study. METHODS: Prodromal HD participants were tested over seven annual visits and were stratified into three groups (low, medium, high) based on their CAG-Age Product (CAP) score, which indicates likely increasing proximity to diagnosis. A cued movement sequence task assessed the impact of advance cueing on response initiation and execution via three levels of advance information. RESULTS: Compared to controls, all CAP groups showed longer initiation and movement times across all conditions at baseline, demonstrating a disease gradient for the majority of outcomes. Across all conditions, the high CAP group had the highest mean for baseline testing, but also demonstrated an increase in movement time across the study. For initiation time, the high CAP group showed the highest mean baseline time across all conditions, but also faster decreasing rates of change over time. CONCLUSIONS: With progress to diagnosis, participants may increasingly use compensatory strategies, as evidenced by faster initiation. However, this occurred in conjunction with slowed execution times, suggesting a decline in effectively accessing control processes required to translate movement into effective execution.

Utility of death certificate data in predicting cancer incidence.

BACKGROUND: Studies often rely on death certificates to identify cancer occurrence. This research assessed the death certificate's ability to reflect cancer incidence and factors that influence agreement with cancer registry data. METHODS: This study compared death certificates to cancer incidence data for an occupational cohort of 1,795 deceased workers who were registered by the Iowa Cancer Registry (ICR) between 1973 and 2005. Logistic regression models examined the effects of factors such as survival time, age at diagnosis, and gender on the odds of agreement between death certificate and incidence data. RESULTS: Death certificates under-reported cancer incidence by 10-100%, depending on site. A 1-year increase in survival decreased the odds of agreement between death certificate and ICR data by 18%. Younger and female workers had increased odds of agreement. CONCLUSIONS: Death certificates can be useful predictors of cancer incidence, particularly for diseases with shorter survival and among subjects diagnosed earlier in life.