A Study Design to Harmonize Patient-Reported Outcomes Across Data Sets.

PURPOSE: Using patient-reported outcomes (PROs) provides important insights from the patient's perspective and can be valuable to monitor and manage treatment-related adverse events during cancer treatment. Additionally, the digital administration of PROs (electronic PROs [ePROs]) provides real-time updates to clinical care teams on treatment-related symptoms in-between clinic visits. However, given the variability in the methodology and timing of the data collection, using and harmonizing these data across different systems remains challenging. Identifying data elements to capture and operating procedures for harmonization across ePRO tools will expedite efforts to generate relevant and robust data on use of ePRO data in clinical care. METHODS: Friends of Cancer Research assembled a consortium of project partners from key health care sectors to align on a framework for ePRO data capture across ePRO tools and assessment of the impact of ePRO data capture on patient outcomes. RESULTS: We identified challenges and opportunities to align ePRO data capture across ePRO tools and aligned on key data elements for assessing the impact of ePRO data capture on patient care and outcomes. Ultimately, we proposed a study protocol to leverage ePRO data for symptom and adverse event management to measure real-world effectiveness of ePRO tool implementation on patient care and outcomes. CONCLUSION: This work provides considerations for harmonizing ePRO data sets and a common framework to align across multiple ePRO tools to assess the value of ePROs for improving patient outcomes. Future efforts to interpret evidence and evaluate the impact of ePRO tools on patient outcomes will be aided by improved alignment across studies.

Communicating Treatment-Related Symptoms Using Passively Collected Data and Satisfaction/Loyalty Ratings: Exploratory Study.

BACKGROUND: Electronic patient-reported outcomes' real time communication of treatment-related symptoms is increasingly associated with better outcomes including longer survival and less health care resource use, but the primary method of collecting this information, static questionnaires, has not evolved. OBJECTIVE: The aim of this paper is to describe the use of Noona's three methods of communicating treatment-related symptoms, which are as follows: (1) Noona symptom questionnaires (NSQ), which incorporate branching logic; (2) a diary; and (3) secure messaging, the last two of which have NSQ reporting functionality. It also aims to explore, using multivariable analyses, whether patients find value using these features. METHODS: Noona users (N=1081) who have an active account for more than 30 days, who responded to the satisfaction/loyalty item, and who were undergoing active cancer treatment (systemic or radiotherapy) in the United States were included in this study. All study data were collected via software embedded within Noona code. This includes metadata, patient activities (measured in clicks), and responses to a satisfaction/loyalty question ("How likely are you to recommend Noona to another patient") displayed on the Noona home page. RESULTS: Noona users expressed a high degree of satisfaction/loyalty when asked to rate how likely they would recommend Noona to another patient. Multivariable analyses indicate small but significant effects for some of the analyses. Use of NSQs were significantly related to satisfaction/loyalty, users of NSQs had significantly higher satisfaction/loyalty than those who did not use any, and secure communication use was significantly higher for those who rated the app highly compared to those who did not. These relationships will likely be further explicated with the use of satisfaction/loyalty questions that focus specifically on feature use. CONCLUSIONS: Noona is well liked by respondents, and exploratory multivariable analyses demonstrate the potential for using passively and minimally invasive data to demonstrate value.

Patient and economic burdens of postherpetic neuralgia in China.

BACKGROUND: Little is known about the patient-reported and economic burdens of postherpetic neuralgia (PHN) among China's urban population. METHODS: This noninterventional study was conducted among adults ≥40 years with PHN who were seeking medical care at eight urban hospitals in China. At one study site, patients completed a questionnaire evaluating the patient-reported disease burden (N=185). The questionnaire consisted of validated patient-reported outcomes including the Brief Pain Inventory (BPI), 5-dimension, 3-level EuroQol (EQ-5D-3L), Medical Outcomes Study Sleep Scale, and Work Productivity and Activity Impairment Questionnaire for Specific Health Problems. Questions on non-pharmacologic therapy and out-of-pocket (OOP) expenses were also included. At all study sites, physicians (N=100) completed a structured review of patient charts (N=828), which was used to derive health care resource utilization and associated costs from the societal perspective. Annual costs in Chinese Yuan Renminbi (RMB) for the year 2016 were converted to US dollars (US$). RESULTS: Patients (N=185, mean age 63.0 years, 53.5% female) reported pain of moderate severity (mean BPI score 4.6); poor sleep quantity (average of 5.3 hrs per night) and quality; and poorer health status on the EQ-5D-3L relative to the general Chinese population. Respondents also reported average annual OOP costs of RMB 16,873 (US$2541) per patient, mainly for prescription PHN medications (RMB 8990 [US$1354]). Substantial work impairment among employed individuals resulted in annual indirect costs of RMB 28,025 (US$4221). In the chart review, physicians reported that patients (N=828) had substantial health resource utilization, especially office visits; 98% had all-cause and 95% had PHN-related office visits. Total annual direct medical costs were RMB 10,002 (US$1507), mostly driven by hospitalizations (RMB 8781 [US$1323]). CONCLUSION: In urban China, PHN is associated with a patient-reported burden, affecting sleep, quality-of-life, and daily activities including work impairment, and an economic burden resulting from direct medical costs and indirect costs due to lost productivity. These burdens suggest the need for appropriate prevention and management of PHN.

The Epidemiology of Herpes Zoster and Postherpetic Neuralgia in China: Results from a Cross-Sectional Study.

INTRODUCTION: Few studies have examined the epidemiology of herpes zoster (HZ) and postherpetic neuralgia (PHN) in China. The aim of this study was to estimate the prevalence of HZ and PHN in China, and to examine the clinical characteristics of patients identified with PHN. METHODS: This was a cross-sectional study conducted in 24 hospitals in seven cities in China. Prevalence of HZ and PHN was determined by physician (n = 100) chart review of patients (n = 36,170) aged ≥ 40 years seeking medical care over a 30- to 60-day period. The health history of patients identified with PHN was obtained and included time since diagnosis of HZ or PHN, time since onset of PHN-related pain, and the methods used for diagnosing HZ and PHN. RESULTS: The prevalence rates of HZ and PHN were 7.7% [95% confidence interval (CI) 7.5-8.0] and 2.3% (95% CI 2.2-2.5), respectively. Of patients with HZ, 29.8% developed PHN. Rates of HZ and PHN increased with age and were highest in patients aged ≥ 70 years (10.6% and 4.1%, respectively). The majority of patients with PHN were diagnosed with HZ (80.9%) and PHN (83.8%) for < 1 year, and had experienced PHN-related pain for < 1 year (80.5%). Patient description and clinical examination were most commonly used to diagnose HZ and PHN. CONCLUSION: These results provide current estimates of the prevalence of HZ and PHN in the general adult population in urban China. These rates are similar to previously reported rates in China and worldwide, and highlight the global nature of HZ and PHN. FUNDING: Pfizer Inc.

Psychometric properties of NIH PROMIS® instruments in bariatric surgery candidates.

OBJECTIVE: Ascertain the psychometric properties of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Depression (PROMIS-D®) and Anxiety (PROMIS-A®) Short Forms in a sample of presurgical bariatric patients. METHOD: This retrospective chart review included 259 patients who completed a presurgical psychological evaluation comprising a semistructured interview and self-report measures. Other data used included demographics, psychiatric diagnoses, and initial psychological clearance for surgery (yes/no). Reliability of the PROMIS-D® and PROMIS-A® instruments was assessed using Cronbach's alpha, interitem correlations, and item-total correlations. Convergent, predictive, and concurrent validity were assessed using various methods (correlations, logistic regressions, and generalized linear models) to determine whether PROMIS® instruments were correlated with similar measures, predicted surgical clearance and psychiatric diagnosis, and whether psychiatric diagnosis status was associated with significantly different PROMIS® scores. Categorical confirmatory factor analyses assessed the factor structure, and multiple-indicator multiple cause models assessed invariance. RESULTS: Patients were predominantly female (78%), white (97%) and middle-aged (M = 43.49, SD = 11.26). Rates of diagnosed anxiety and depression-related disorders were high (17% and 23%). At least 65% of respondents reported "never" or "rarely" experiencing symptoms across both measures, and the mean T scores for the PROMIS-A® and PROMIS-D® were 48.31 (SD = 8.99) and 48.64 (SD = 9.49), respectively. Both measures demonstrated good psychometric properties and were essentially unidimensional. CONCLUSIONS: Analyses supported using both PROMIS® measures. Additionally, two subgroups were identified: those who reported virtually no symptoms of anxiety or depression, likely because they want surgical approval, and those not receiving initial psychological clearance for surgery based on PROMIS® self-reported scores indicating distress and clinician-diagnosed psychopathology. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Epidemiology of physician-diagnosed neuropathic pain in Brazil.

OBJECTIVES: Estimate the prevalence of neuropathic pain (NeP) among chronic pain patients attending Brazilian hospitals and pain clinics in São Paulo, Ceara, and Bahia and explore clinical characteristics by subtypes: painful diabetic peripheral neuropathy (pDPN), central neuropathic pain (CNP), chronic low back pain with a neuropathic component (CLBP-NeP), postherpetic neuralgia (PHN), post-traumatic neuropathic pain (PTN), and post-surgical neuropathic pain (PSN). METHODS: Physicians screened patients reporting chronic pain for ≥3 months (n=2,118) for probable NeP, using the Douleur Neuropathique 4 questionnaire and physician assessment, and reported their NeP subtype(s), symptoms, and medications. Identified NeP patients completed a questionnaire including treatment experiences, quality of life EuroQol 5 Dimensions [EQ-5D]), pain severity and interference (Brief Pain Inventory [BPI]), and Work Productivity and Activity Impairment scales. Descriptive analyses were performed by NeP subtype. RESULTS: The prevalence of probable NeP was 14.5% (n=307). NeP patients were mostly female (80.5%), middle-aged (mean [M]=52.5, SD=13.9), and Pardo (44.3%). Of those diagnosed with an NeP subtype (n=209), the largest proportions were CLBP-NeP (36.8%), followed by pDPN (18.7%), CNP (17.7%), PTN (17.2%), PSN (13.4%), and PHN (3.3%). Across subtypes, the most widely reported symptoms were numbness (range: 62.2%-89.7%) and hyperalgesia (range: 32.1%-76.9%) and the most commonly prescribed pain analgesics were NSAID (range: 18.2%-57.1%), opioids (range: 0.0%-39.3%), and antiepileptics (range: 18.2%-57.1%). PTN and PSN patients reported the least favorable EQ-5D index scores (M=0.42, SD=0.19) and BPI-Pain Severity scores (M=7.0, SD=1.9), respectively. Those diagnosed with CNP had the least favorable BPI-Pain Interference scores (M=6.0, SD=2.7). Patients with PHN reported the least impairment based on EQ-5D index scores (M=0.60, SD=0.04). Those with pDPN had the most favorable BPI scores (BPI-Pain Severity: M=4.6, SD=2.3; BPI-Pain Interference: M=4.7, SD=2.7). CONCLUSION: Evaluation of chronic pain patients in Brazil yielded a 14.5% probable NeP prevalence. NSAIDs and opioids were commonly used, and there was a high incidence of NeP-related symptoms with varying levels of dysfunction across subtypes.

Characteristics of patients with neuropathic pain syndromes screened by the painDETECT questionnaire and diagnosed by physician exam.

BACKGROUND: The aim of this study was to identify the clinical characteristics, treatment usage, and health outcomes of US adults diagnosed with neuropathic pain (NeP) by experienced physicians. METHODS: Adults with scores exceeding the threshold for probable NeP (painDETECT ≥19) and diagnosed with NeP by a qualified physician completed a questionnaire that included comorbid conditions, pain symptoms and experiences, medication use, health status (3-level EuroQol 5 Dimensions (EQ-5D-3L]: health utilities index and visual analog scale), pain severity and interference with functioning (Brief Pain Inventory), and work and activity impairment (Work Productivity and Activity Impairment questionnaire). Descriptive analyses were performed for each NeP subtype. RESULTS: Participants (n=295) were predominantly female (64.4%), middle-aged (53.9%), and white (51.5%). Chronic low back pain was the most frequently diagnosed major NeP syndrome (n=166), followed by diabetic peripheral neuropathy (n=58), post-trauma neuropathy (n=47), post-surgical neuropathy (n=28), and central NeP (n=23). An additional 45 participants were diagnosed, but did not meet the criteria for the aforementioned subtypes. Participants could be diagnosed with multiple subtypes. Across each NeP subtype, patients reported high rates of comorbid disease, including arthritis (range: 39.1%-64.3%) and high blood pressure (range: 26.1%-69.0%), as well as symptomology that included numbness (range: 68.1%-91.4%) and changes in muscular strength (range: 24.1%-65.2%). The majority of patients reported back pain (range: 77.8%-95.7%) and arthritis/joint pain (range: 68.1%-78.6%). The most commonly reported types of NeP pain medication were non-steroidal anti-inflammatory drugs (range: 43.1%-70.2%), weak opioids (range: 22.2%-39.3%), and strong opioids (range: 8.7%-28.6%). All six NeP groups generally reported similar levels of dysfunction on all self-report measures. The most notable finding was that the EuroQol-5D-3L health utilities index scores for each of the six groups were lower than the US norms by a clinically important amount. CONCLUSION: These exploratory findings indicate that patients with NeP across different etiologies are medically complex and experience impaired function across multiple domains.

Systemwide Implementation of Patient-Reported Outcomes in Routine Clinical Care at a Children's Hospital.

BACKGROUND: Despite a growing literature on patient-reported outcomes (PROs), little has been written to guide development of a standardized, systemwide PRO program across multiple clinics and conditions. A PRO implementation program, which was created at Cincinnati Children's Hospital Medical Center, a large children's hospital, can serve as a standardized approach for the use of PROs in a clinical setting. METHODS: Recommended standardized PRO implementation components include identification of a committed clinical leader and team, selection of an instrument that addresses the identified outcome of interest, specifying threshold scores that indicate when an intervention is needed, identification of clinical interventions to be triggered by threshold scores, provision of training for providers and staff involved in the PRO implementation process, and the measurement and monitoring of PRO use. RESULTS: For each instrument, the completion goal is 80%, defined as the number of PRO measures that were actually completed divided by the number that should have been completed. The overall combined completion rate is 75% for the 68 unique instruments currently in use. Case studies of specific clinical team experiences demonstrate the value of using PROs and the implementation components and shows how PROs are used to promote patient-centered care. CONCLUSION: Data on PRO implementation are collected on an ongoing basis to confirm the value of the program, define ongoing improvement, and fuel collaborative research to further refine essential implementation components and successful spread. Next steps include measuring the influence of PRO use on coproduction of patient-centered clinical care and the impact PRO measurement has on patient outcomes.

Sleep Tracking and Exercise in Patients With Type 2 Diabetes Mellitus (Step-D): Pilot Study to Determine Correlations Between Fitbit Data and Patient-Reported Outcomes.

BACKGROUND: Few studies assessing the correlation between patient-reported outcomes and patient-generated health data from wearable devices exist. OBJECTIVE: The aim of this study was to determine the direction and magnitude of associations between patient-generated health data (from the Fitbit Charge HR) and patient-reported outcomes for sleep patterns and physical activity in patients with type 2 diabetes mellitus (T2DM). METHODS: This was a pilot study conducted with adults diagnosed with T2DM (n=86). All participants wore a Fitbit Charge HR for 14 consecutive days and completed internet-based surveys at 3 time points: day 1, day 7, and day 14. Patient-generated health data included minutes asleep and number of steps taken. Questionnaires assessed the number of days of exercise and nights of sleep problems per week. Means and SDs were calculated for all data, and Pearson correlations were used to examine associations between patient-reported outcomes and patient-generated health data. All respondents provided informed consent before participating. RESULTS: The participants were predominantly middle-aged (mean 54.3, SD 13.3 years), white (80/86, 93%), and female (50/86, 58%). Use of oral T2DM medication correlated with the number of mean steps taken (r=.35, P=.001), whereas being unaware of the glycated hemoglobin level correlated with the number of minutes asleep (r=-.24, P=.04). On the basis of the Fitbit data, participants walked an average of 4955 steps and slept 6.7 hours per day. They self-reported an average of 2.0 days of exercise and 2.3 nights of sleep problems per week. The association between the number of days exercised and steps walked was strong (r=.60, P<.001), whereas the association between the number of troubled sleep nights and minutes asleep was weaker (r=.28, P=.02). CONCLUSIONS: Fitbit and patient-reported data were positively associated for physical activity as well as sleep, with the former more strongly correlated than the latter. As extensive patient monitoring can guide clinical decisions regarding T2DM therapy, passive, objective data collection through wearables could potentially enhance patient care, resulting in better patient-reported outcomes.

The association between body mass index and health and economic outcomes in Brazil.

BACKGROUND: Obesity is associated with significant physical, psychosocial and economic burden globally. In Brazil, almost 50% of the population is either overweight or obese. The prevalence of morbid obesity increased by 255% between 1975 and 2003. The current study sought to quantify the relationship between weight status and health outcomes. METHODS: Data from three waves (2011, 2012, and 2015) of the Brazil National Health and Wellness Survey, an Internet-based survey administered to a demographically diverse sample of Brazilian adults, were used. Body mass index category was calculated based on self-reported height and weight and respondents were categorized into five groups (normal, overweight, obese class I, obese class II, obese class III; n = 34,254). Multivariable analyses, controlling for sociodemographic variables and health history, tested the association with body mass index group and outcomes including health status (Medical Outcomes Study Short Form 12-Item Health Survey version 2/Medical Outcomes Study Short Form 36-Item Health Survey version 2), work productivity (Work Productivity and Activity Impairment-General Health Questionnaire), and costs associated with work impairment (indirect costs), self-reported healthcare resource use and associated direct costs. RESULTS: Overall, 53.6% of the surveyed Brazilian population reported being overweight or obese. In virtually all the analyses, increasing body mass index group was associated with significant and progressively worse outcomes. Most notable was the finding that hospitalization costs were over twice as high (R$3141.84 vs. R$1349.60) and indirect costs were nearly double (R$1656.80 vs. R$884.15) for obesity class III than for normal body mass index respondents. CONCLUSIONS: Obesity rates in Brazil are considerable and, from a patient and societal perspective, increasingly burdensome, thereby highlighting the need for stakeholders to prioritize strategies for weight management interventions.

Impact of Obesity on Work Productivity in Different US Occupations: Analysis of the National Health and Wellness Survey 2014 to 2015.

OBJECTIVE: The aim of this study was to quantify the relationship between workers' body mass index and work productivity within various occupations. METHODS: Data from two administrations (2014 and 2015) of the United States (US) National Health and Wellness Survey, an Internet-based survey administered to an adult sample of the US population, were used for this study (n = 59,772). Occupation was based on the US Department of Labor's 2010 Standardized Occupation Codes. Outcomes included work productivity impairment and indirect costs of missed work time. RESULTS: Obesity had the greatest impact on work productivity in Construction, followed by Arts and Hospitality occupations. Outcomes varied across occupations; multivariable analyses found significant differences in work productivity impairment and indirect costs between normal weight and at least one obesity class. CONCLUSION: Obesity differentially impacted productivity and costs, depending upon occupation.

The prevalence of probable neuropathic pain in the US: results from a multimodal general-population health survey.

BACKGROUND: The prevalence of neuropathic pain (NeP) has been estimated within specific health conditions; however, there are no published data on its broad prevalence in the US. The current exploratory study addresses this gap using the validated PainDetect questionnaire as a screener for probable NeP in a general-population health survey conducted with a multimodal recruitment strategy to maximize demographic representativeness. MATERIALS AND METHODS: Adult respondents were recruited from a combination of Internet panels, telephone lists, address lists, mall-based interviews, and store-receipt invitations using a random stratified-sampling framework, with strata defined by age, sex, and race/ethnicity. Older persons and minorities were oversampled to improve prevalence estimates. Results were weighted to match the total adult US population using US Census data. Demographic information was collected, and respondents who experienced physical pain in the past 12 months completed the PainDetect and provided additional pain history. A cutoff score of 19 or greater on the PainDetect was used to define probable NeP. RESULTS: A total of 24,925 respondents (average response rate 2.5%) provided demographic data (52.2% female, mean age 51.5 years); 15,751 respondents reported pain (63.7%), of which 2,548 (15.7%, 95% confidence interval 14.9%-16.5%) had probable NeP based on the PainDetect, which was 10% (95% confidence interval 9.5%-10.5%) of all respondents. Among those reporting pain, the prevalence of probable NeP among Blacks and Hispanics was consistently higher than Whites in each age- and sex group. The highest prevalence among those with pain was among male Hispanics 35-44 years (32.4%) and 45-54 years (24.2%) old. The most commonly used medications reported by those with probable NeP were nonsteroidal anti-inflammatory drugs (44.2%), followed by weak opioids (31.7%), antiepileptics (10.9%), and strong opioids (10.9%). CONCLUSION: This is the first study to provide an estimate of the prevalence of probable NeP in the US, showing significant variation by age and ethnicity.

Health-related quality of life in children with heart failure as perceived by children and parents.

Advancements in paediatric heart failure management have resulted in improved survival and a focus on long-term outcomes including health-related quality of life. We compared health-related quality of life in children with heart failure with healthy patients, children with chronic conditions, and children with cardiovascular disease. Families (n=63) and children (n=73) aged 2-20 years with heart failure were enrolled and compared with data previously published for healthy patients (n=5480), those with chronic conditions (n=247), and those with cardiovascular disease (n=347). Patients and parents completed the PedsQL 4.0 and the Cardiac 3.0 Module health-related quality-of-life questionnaires. PedsQL scores including Total, Psychosocial Health Summary, and Physical were compared between groups. In general, patients with heart failure had lower scores than the healthy population (p=0.001), and comparable scores with those with chronic conditions. Parents perceived no difference in physical scores for children with heart failure when compared with healthy children, and perceived higher scores for children with heart failure when compared with those with chronic conditions (p⩽0.003). Furthermore, children with heart failure had decremental health-related quality-of-life scores as the American Heart Association stage of heart failure increased, such that patients with stage C heart failure had scores similar to children with severe cardiovascular disease. Children with heart failure reported significantly impaired health-related quality of life compared with healthy children and similar scores compared with children with chronic conditions. Parental perceptions appear to underestimate these impairments. Children with heart failure appear to have progressive impairment of health-related quality of life with advancing stage of heart failure.

Multidimensional assessment of spirituality/religion in patients with HIV: conceptual framework and empirical refinement.

A decade ago, an expert panel developed a framework for measuring spirituality/religion in health research (Brief Multidimensional Measure of Religiousness/Spirituality), but empirical testing of this framework has been limited. The purpose of this study was to determine whether responses to items across multiple measures assessing spirituality/religion by 450 patients with HIV replicate this model. We hypothesized a six-factor model underlying a collective of 56 items, but results of confirmatory factor analyses suggested eight dimensions: Meaning/Peace, Tangible Connection to the Divine, Positive Religious Coping, Love/Appreciation, Negative Religious Coping, Positive Congregational Support, Negative Congregational Support, and Cultural Practices. This study corroborates parts of the factor structure underlying the Brief Multidimensional Measure of Religiousness/Spirituality and some recent refinements of the original framework.

Measuring sports participation decisional conflict in youth with cardiac pacemakers and/or ICDs.

AIMS: We examined the Decisional Conflict Scale to determine if it would be useful to measure conflict around sports participation decision-making in youth with cardiac pacemakers and/or implantable cardioverter defibrillators. BACKGROUND: Sports participation decisions made by parents and youth with implanted cardiac devices can have profound implications. Contact sports can result in damage to the device and leads, but the value of exercise is well documented and restriction from a cherished activity can increase resistance and distress in the young. The extent of this problem is unknown. METHODS: An explanatory mixed methods design was used with a convenience sample (N=35) of youth aged 12-21 (Mean=16.5; sd=3) years awaiting services at an electrophysiology clinic. Data were collected between 2007 and 2008. The Decisional Conflict Scale is a self-report measure, used worldwide in adult populations. Analyses and interviews determined the properties of the measure and whether the instrument captured conflict. RESULTS: The scale showed strong internal consistency (Cronbach alpha=0.87). Overall scores were low (Mean=17.31; SD=10.99; range=0-37). There was no statistically significant difference (P>0.05) in total scores between boys (n=25) and girls (n=10) using independent t-tests. Qualitative analysis documented conflict and non-adherence to clinician recommendation despite low scores. CONCLUSIONS: Analyses indicate that youth aged 12-21 years understand and can effectively complete the Decisional Conflict Scale, but this instrument alone did not capture all conflict. These results can guide study of the extent of this problem and eventual development of an intervention to support sports participation decision-making.

Spirituality and religiosity in patients with HIV: a test and expansion of a model.

BACKGROUND: A causal model developed by Koenig suggests that higher levels of spirituality and religiosity effect intermediary variables and eventually result in better mental health, which then positively affects physical function. PURPOSE/METHODS: Using structural equation modeling, we tested the model and expanded versions that use self-report data of patients with HIV (n = 345). RESULTS: All models demonstrated good overall fit with significant parameters. The final model found that increased spirituality/religiosity predicted increased religious coping, which influenced social support. Social support, in turn, positively influenced depressed mood (as a measure of mental health); depressed mood affected fatigue; and both variables predicted self-reported physical function. These three variables predicted health rating/utility for one's health state. Additional analyses found that two covariates, religiosity and race, differentially predicted spirituality/religiosity and religious coping. CONCLUSION: In patients with HIV, an expanded version of Koenig's model found that increased spirituality/religiosity is positively associated with self-reported outcomes.

Development of an electronic medical record-based clinical decision support tool to improve HIV symptom management.

Common symptoms associated with HIV disease and its management are often underrecognized and undertreated. A clinical decision support tool for symptom management was developed within the Veterans Health Administration electronic medical record (EMR), aiming at increasing provider awareness of and response to common HIV symptoms. Its feasibility was studied in March to May 2007 by implementing it within a weekly HIV clinic, comparing a 4-week intervention period with a 4-week control period. Fifty-six patients and their providers participated in the study. Patients' perceptions of providers' awareness of their symptoms, proportion of progress notes mentioning any symptom(s) and proportion of care plans mentioning any symptom(s) were measured. The clinical decision support tool used portable electronic "tablets" to elicit symptom information at the time of check-in, filtered, and organized that information into a concise and clinically relevant EMR note available at the point of care, and facilitated clinical responses to that information. It appeared to be well accepted by patients and providers and did not substantially impact workflow. Although this pilot study was not powered to detect effectiveness, 25 (93%) patients in the intervention group reported that their providers were very aware of their symptoms versus 27 (75%) control patients (p = 0.07). The proportion of providers' notes listing symptoms was similar in both periods; however, there was a trend toward including a greater number of symptoms in intervention period progress notes. The symptom support tool seemed to be useful in clinical HIV care. The Veterans Health Administration EMR may be an effective "laboratory" for developing and testing decision supports.

Spiritual well-being and mental health outcomes in adolescents with or without inflammatory bowel disease.

PURPOSE: The purpose of this study was threefold: 1) to describe spiritual well-being (existential and religious well-being) in adolescents with inflammatory bowel disease (IBD) versus healthy peers; 2) to examine associations of spiritual well-being with mental health outcomes (emotional functioning and depressive symptoms); and 3) to assess the differential impact of existential versus religious well-being on mental health. METHODS: A total of 155 adolescents aged 11-19 years from a children's hospital and a university hospital filled out questionnaires including the Spiritual Well-Being Scale, the Children's Depression Inventory-Short Form, and the Pediatric Quality of Life Inventory. Covariates in multivariable models included demographics, disease status, and interactions. RESULTS: Participants' mean (SD) age was 15.1 (2.0) years; 80 (52%) were male; and 121 (78%) were of white ethnicity. Levels of existential and religious well-being were similar between adolescents with IBD and healthy peers. In multivariable analyses, existential well-being was associated with mental health (partial R(2) change = .08-.11, p < .01) above and beyond other characteristics (total R(2) = .23, p < .01). Presence of disease moderated both the relationship between existential well-being and emotional functioning and that between religious well-being and depressive symptoms: that is, the relationships were stronger in adolescents with IBD as compared with healthy peers. Religious well-being was only marginally significantly associated with mental health after controlling for other factors. CONCLUSIONS: Although both healthy adolescents and those with IBD had high levels of spiritual well-being, having IBD moderated the relationship between spiritual well-being and mental health. Meaning/purpose was related to mental health more than was connectedness to the sacred.

The association of perceived partner-related social support with self-reported outcomes in women post-mastectomy.

Marital satisfaction is an important indicator of adaptation in patients with cancer; however, its relationship to medium-to-long-term health-related outcomes is less well understood. Married women (N = 152) at least six months post-mastectomy were surveyed to determine whether marital satisfaction predicted non-weight-related body image distress (BID), pain impact, and mood, or whether the directionality of this association operated in reverse. Structural equation modeling indicated that the model predicting medium-to-long-term health-related outcomes from satisfaction better fit the data and that time influences mood.

Quantifying the decrement in utility from perceived side effects of combination antiretroviral therapies in patients with HIV.

BACKGROUND: The decrement in utility attributable to side effects from combination antiretroviral therapy (CART) is unknown and likely to influence clinical decisions regarding CART initiation and cost-effectiveness. OBJECTIVE: To quantify the decrement in utility attributable to side effects from CART. METHODS: We estimated SF-6D utilities (quality-of-life weights on a scale from 0.29 [worst possible health] to 1.00 [perfect health]) from SF-12 scores among patients with HIV in the Veterans Aging Cohort Study by using a published and validated conversion algorithm. We then compared utilities among patients who: 1) did not have bothersome symptoms while taking CART; 2) had bothersome symptoms that they thought might be due to CART; and 3) had bothersome symptoms that they were confident were due to CART; we controlled for other characteristics known to influence quality of life and stratified analyses by CD4 count. RESULTS: Among 1864 patients with available data, symptoms perceived to be attributable to CART were associated with a mean (95% confidence interval) decrement in utility of 0.06 (0.05, 0.08) points in univariate analyses and 0.08 (0.06, 0.10) in multivariable analyses, clinically significant differences that are comparable to utility decrements reported for partial impotence or mild angina. Other significant predictors of changes in SF-6D utilities were hazardous alcohol consumption, recent drug use, cigarette smoking, homelessness, and African American race (R(2) = 0.12). Stratifying by CD4 count, symptoms attributable to CART side effects decreased utility by 0.03 to 0.08 points. CONCLUSIONS: Symptoms perceived to be related to CART are associated with a substantial decrement in utility.