Object naming tests are commonly included in neuropsychological test batteries. Differential item functioning (DIF) in these tests due to cultural and language differences may compromise the validity of cognitive measures in diverse populations. We evaluated 26 object naming items for DIF due to Spanish and English language translations among Latinos (n=1,159), mean age of 70.5 years old (Standard Deviation (SD)±7.2), using the following four item response theory-based approaches: Mplus/Multiple Indicator, Multiple Causes (Mplus/MIMIC; Muthén & Muthén, 1998–2011), Item Response Theory Likelihood Ratio Differential Item Functioning (IRTLRDIF/MULTILOG; Thissen, 1991, 2001), difwithpar/Parscale (Crane, Gibbons, Jolley, & van Belle, 2006; Muraki & Bock, 2003), and Differential Functioning of Items and Tests/MULTILOG (DFIT/MULTILOG; Flowers, Oshima, & Raju, 1999; Thissen, 1991). Overall, there was moderate to near perfect agreement across methods. Fourteen items were found to exhibit DIF and 5 items observed consistently across all methods, which were more likely to be answered correctly by individuals tested in Spanish after controlling for overall ability.

Context

Estimation of six-month prognosis is essential in hospice referral decisions, but accurate, evidence-based tools to assist in this task are lacking.

Objectives

To develop a new prognostic model, the Patient-Reported Outcome Mortality Prediction Tool (PROMPT), for six-month mortality in community-dwelling elderly patients.

Methods

We used data from the Medicare Health Outcomes Survey (MHOS) linked to vital status information. Respondents were 65 years old or older, with self-reported declining health over the past year (n=21,870), identified from four MHOS cohorts (1998–2000, 1999–2001, 2000–2002, and 2001–2003). A logistic regression model was derived to predict six-month mortality, using sociodemographic characteristics, comorbidities, and health-related quality of life (HRQOL), ascertained by measures of activities of daily living (ADLs) and the Medical Outcomes Study Short Form-36 Health Survey (SF-36®); k-fold cross-validation was used to evaluate model performance, which was compared to existing prognostic tools.

Results

The PROMPT incorporated 11 variables including four HRQOL domains: general health perceptions, ADLs, social functioning, and energy/fatigue. The model demonstrated good discrimination (c-statistic=0.75) and calibration. Overall diagnostic accuracy was superior to existing tools. At cutpoints of 10%–70%, estimated six-month mortality risk sensitivity and specificity ranged from 0.8%–83.4% and 51.1%–99.9%, respectively, and positive likelihood ratios at all mortality risk cut-points ≥40% exceeded 5.0. Corresponding positive and negative predictive values were 23.1%–64.1% and 85.3%–94.5%. Over 50% of patients with estimated six-month mortality risk ≥30% died within 12 months.

Conclusion

The PROMPT, a new prognostic model incorporating HRQOL, demonstrates promising performance and potential value for hospice referral decisions. More work is needed to evaluate the model.

Objective

Sleep disturbance and hot flashes are common during menopause, but their association is not well understood. We sought to understand the associations among sleep disturbance and the frequency, bothersomeness, and interference of hot flashes in mid-life women.

Study Design

STRIDE is a study of women ages 40–65 years at varied menopausal stages. We examined the cross-sectional associations of sleep disturbance with the frequency and bothersomeness of hot flashes, and interference of hot flashes with work, social, and leisure activities during the 2nd year of STRIDE.

Main Outcome Measure

Self-reported sleep disturbance

Results

Of the 623 women with complete data, 370 (59%) reported having hot flashes. Bivariate analyses showed that reporting hot flashes with bother, but not hot flashes alone, was associated with sleep disturbance (odds ratio [OR] [95% confidence interval (CI)]: 2.8[2.0–4.0] and 1.3[0.7–2.5], respectively). In multivariable models, women reporting bothersome hot flashes were more likely to report sleep disturbance (OR [95% CI]: 2.1 [1.4–3.2]) compared to women who reported no hot flashes. When the perceived interference of hot flashes with work, social activities, and leisure activities were included in the model, the relationships between bothersome hot flashes and sleep disturbance disappeared.

Conclusions

Hot flashes are not associated with sleep disturbance, unless they are bothersome. Mid-life patients should routinely be queried about the bothersomeness of their hot flashes.

Objective

Adjust for subgroup differences in extreme response tendency (ERT) in ratings of health care, which otherwise obscure disparities in patient experience.

Data Source

117,102 respondents to the 2004 Consumer Assessment of Healthcare Providers and Systems (CAHPS) Medicare Fee-for-Service survey.

Study Design

Multinomial logistic regression is used to model respondents‘ use of extremes of the 0–10 CAHPS rating scales as a function of education. A new two-stage model adjusts for both standard case-mix effects and ERT. Ratings of subgroups are compared after these adjustments.

Principal Findings

Medicare beneficiaries with greater educational attainment are less likely to use both extremes of the 0–10 rating scale than those with less attainment. Adjustments from the two-stage model may differ substantially from standard adjustments and resolve or attenuate several counterintuitive findings in subgroup comparisons.

Conclusions

Addressing ERT may be important when estimating disparities or comparing providers if patient populations differ markedly in educational attainment. Failures to do so may result in misdirected resources for reducing disparities and inaccurate assessment of some providers. Depending upon the application, ERT may be addressed by the two-stage approach developed here or through specified categorical or stratified reporting.

Purpose

To study the associations of eye diseases and visual symptoms with the most widely used health-related quality of life (HRQOL) generic profile measure.

Design

HRQOL was assessed using the SF-36® version 1 survey administered to a sample of patients receiving care provided by a physician group practice association.

Methods

Eye dieases, ocular symptoms, and general health was assessed in a sample of patients from 48 physician groups. A total of 18,480 surveys were mailed out and 7,093 returned; 5,021of these had complete data. Multiple linear regression models were used to examine the decrements in self-reported physical and mental health associated with eye diseases and symptoms, including trouble seeing and blurred vision.

Results

Nine percent of the respondents had cataracts, 2% had age-related macular degeneration, 2% glaucoma, 8% blurred vision, and 13% trouble seeing. Trouble seeing and blurred vision both had statistically unique associations with worse scores on the SF-36 mental health summary score. Only trouble seeing had a significant association with the SF-36 physical health summary score. While these ocular symptoms were significantly associated with SF-36® scores, having an eye disease (cataracts, glaucoma, macular degeneration) was not, after adjusting for other variables in the model.

Conclusions

Our results suggest an important link between visual symptoms and general HRQOL. The study extends the findings of prior research to show that both trouble seeing and blurred vision have independent, measurable associations with HRQOL, while the presence of specific eye diseases may not.

Objective

Assess proxy respondent effects on health care evaluations by Medicare beneficiaries.

Data Source

110,215 respondents from the nationally representative 2001 CAHPS® Medicare Fee-for-Service Survey.

Study Design/Data Collection/Extraction Methods

We compare the effects of both proxy respondents and proxy assistance (reading, writing, or translating) on 23 “objective” report items and four “subjective” global measures of health care experiences using propensity-score-weighted regression. We assess whether proxy effects differ among spouses, other relatives, or nonrelatives.

Principal Findings

Proxy respondents provide less positive evaluations of beneficiary health care experiences than otherwise similar self-reporting beneficiaries for more subjective global ratings (average effect of 0.21 standard deviations); differences are smaller for relatively objective and specific report items. Proxy assistance differences are similar, but about half as large. Reports from spouse proxy respondents are more positive than those from other proxies and are similar to what would have been reported by the beneficiaries themselves. Standard regression techniques may overestimate proxy effects in this instance.

Conclusions

One should treat proxy responses to subjective ratings cautiously. Even seemingly innocuous reading, writing, and translation by proxies may influence answers. Spouses may be accurate proxies for the elderly in evaluations of health care.

The motor examination section of the unified Parkinson's disease rating scale (UPDRS) is widely used in research but few studies have examined whether subscales exist that tap relatively distinct motor abnormalities. We analyzed data from 193 persons enrolled in a population-based study in Central California. Patients were examined after overnight PD medication washout (“OFF” state) and approximately one hour after taking medication (“ON” state). We performed confirmatory factor analysis of the UPDRS for OFF and ON state examinations; correlations, reliability, and relative validity of resulting subscales were evaluated. A model with five factors (gait/posture, tremor, rigidity, bradykinesia affecting the left extremities, bradykinesia affecting the right extremities) fit the data well, with similar results for OFF and ON states. Internal consistency reliability coefficients were 0.90 or higher for all subscales. The gait/posture subscale most strongly discriminated across levels of patient reported PD symptom severity and of how PD affects them on a daily basis. Compared to the right sided bradykinesia subscale, the left sided bradykinesia subscale had higher discrimination across levels of self-reported PD symptom severity and functional impairment. This supports motor UPDRS containing multiple subscales that can be analyzed separately and provide information distinct from the total score that may be useful in clinical studies.

Purpose

To provide minimally important difference (MID) estimates for the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) in a longitudinal observational cohort.

Methods

We administered the UCLA SCTC GIT 2.0 to 115 patients with SSc at 2 time points 6 months apart. UCLA SCTC GIT 2.0 has 7 multi-item scales: Reflux, Distention/Bloating, Diarrhea, Fecal Soilage, Constipation, Emotional Well-being, and Social Functioning and a Total GIT score. All scales are scored from 0 (better HRQOL) to 3 (worse HRQOL) except the diarrhea and constipation scales (ranges are 0–2 and 0– 2.5, respectively). Patients also rated their overall, upper, and lower GIT involvement during the 2nd visit using a “Much better, somewhat better, almost the same, somewhat worse, or much worse” response scale. The minimally changed group was defined by those reporting they were somewhat better or somewhat worse compared to 1st visit.

Results

Study participants were 84% female and 81% white with a mean disease duration of 6.9 years. The MID estimates for improvement ranged from 0.07 for the Social Functioning scale to 0.36 for Emotional Well-Being scale. For worsening, the MID estimates ranged from 0.06 for Fecal Soilage scale to 0.21 for the Social Functioning Scale.

Conclusion

We provide MID estimates for the UCLA SCTC GIT 2.0 scales. This information can aid in interpreting scale scores in future RCTs and observational studies.

Item response theory (IRT) has a number of potential advantages over classical test theory in assessing self-reported health outcomes. IRT models yield invariant item and latent trait estimates (within a linear transformation), standard errors conditional on trait level, and trait estimates anchored to item content. IRT also facilitates evaluation of differential item functioning, inclusion of items with different response formats in the same scale, and assessment of person fit and is ideally suited for implementing computer adaptive testing. Finally, IRT methods can be helpful in developing better health outcome measures and in assessing change over time. These issues are reviewed, along with a discussion of some of the methodological and practical challenges in applying IRT methods.

Objective

To estimate the effect of survey mode (mail versus telephone) on reports and ratings of hospital care.

Data Sources/Study Setting

The total sample included 20,826 patients discharged from a group of 24 distinct hospitals in three states (Arizona, Maryland, New York). We collected CAHPS® data in 2003 by mail and telephone from 9,504 patients, of whom 39 percent responded by telephone and 61 percent by mail.

Study Design

We estimated mode effects in an observational design, using both propensity score blocking and (ordered) logistic regression on covariates. We used variables derived from administrative data (either included as covariates in the regression function or used in estimating the propensity score) grouped in three categories: individual characteristics, characteristics of the stay and hospital, and survey administration variables.

Data Collection/Extraction Methods

We mailed a 66-item questionnaire to everyone in the sample and followed up by telephone with those who did not respond.

Principal Findings

We found significant (p<.01) mode effects for 13 of the 21 questions examined in this study. The maximum magnitude of the survey mode effect was an 11 percentage-point difference in the probability of a “yes” response to one of the survey questions. Telephone respondents were more likely to rate care positively and health status negatively, compared with mail respondents. Standard regression-based case-mix adjustment captured much of the mode effects detected by propensity score techniques in this application.

Conclusions

Telephone mode increases the propensity for more favorable evaluations of care for more than half of the items examined. This suggests that mode of administration should be standardized or carefully adjusted for. Alternatively, further item development may minimize the sensitivity of items to mode of data collection.

Objective

To examine the predictors of unit and item nonresponse, the magnitude of nonresponse bias, and the need for nonresponse weights in the Consumer Assessment of Health Care Providers and Systems (CAHPS®) Hospital Survey.

Methods

A common set of 11 administrative variables (41 degrees of freedom) was used to predict unit nonresponse and the rate of item nonresponse in multivariate models. Descriptive statistics were used to examine the impact of nonresponse on CAHPS Hospital Survey ratings and reports.

Results

Unit nonresponse was highest for younger patients and patients other than non-Hispanic whites (p<.001); item nonresponse increased steadily with age (p<.001). Fourteen of 20 reports of ratings of care had significant (p<.05) but small negative correlations with nonresponse weights (median −0.06; maximum −0.09). Nonresponse weights do not improve overall precision below sample sizes of 300–1,000, and are unlikely to improve the precision of hospital comparisons. In some contexts, case-mix adjustment eliminates most observed nonresponse bias.

Conclusions

Nonresponse weights should not be used for between-hospital comparisons of the CAHPS Hospital Survey, but may make small contributions to overall estimates or demographic comparisons, especially in the absence of case-mix adjustment.

Objective

To review the existing literature (1980–2003) on survey instruments used to collect data on patients' perceptions of hospital care.

Study Design

Eight literature databases were searched (PubMED, MEDLINE Pro, MEDSCAPE, MEDLINEplus, MDX Health, CINAHL, ERIC, and JSTOR). We undertook 51 searches with each of the eight databases, for a total of 408 searches. The abstracts for each of the identified publications were examined to determine their applicability for review.

Methods of Analysis

For each instrument used to collect information on patient perceptions of hospital care we provide descriptive information, instrument content, implementation characteristics, and psychometric performance characteristics.

Principal Findings

The number of institutional settings and patients used in evaluating patient perceptions of hospital care varied greatly. The majority of survey instruments were administered by mail. Response rates varied widely from very low to relatively high. Most studies provided limited information on the psychometric properties of the instruments.

Conclusions

Our review reveals a diversity of survey instruments used in assessing patient perceptions of hospital care. We conclude that it would be beneficial to use a standardized survey instrument, along with standardization of the sampling, administration protocol, and mode of administration.

Objective

Patients in the U.S. often turn to complementary and alternative medicine (CAM) and may use it concurrently with conventional medicine to treat illness and promote wellness. However, clinicians vary in their openness to the merging of treatment paradigms. Because integration of CAM with conventional medicine can have important implications for health care, we developed a survey instrument to assess clinicians' orientation toward integrative medicine.

Study Setting

A convenience sample of 294 acupuncturists, chiropractors, primary care physicians, and physician acupuncturists in academic and community settings in California.

Data Collection Methods

We used a qualitative analysis of structured interviews to develop a conceptual model of integrative medicine at the provider level. Based on this conceptual model, we developed a 30-item survey (IM-30) to assess five domains of clinicians' orientation toward integrative medicine: openness, readiness to refer, learning from alternate paradigms, patient-centered care, and safety of integration.

Principal Findings

Two hundred and two clinicians (69 percent response rate) returned the survey. The internal consistency reliability for the 30-item total scale and the five subscales ranged from 0.71 to 0.90. Item-scale correlations for the five subscales were higher for the hypothesized subscale than other subscales 75 percent or more of the time. Construct validity was supported by the association of the IM-30 total scale score (0–100 possible range, with a higher score indicative of greater orientation toward integrative medicine) with hypothesized constructs: physician acupuncturists scored higher than physicians (71 versus 50, p<.001), dual-trained practitioners scored higher than single-trained practitioners (71 versus 62, p<.001), and practitioners' self-perceived “integrativeness” was significantly correlated (r=0.60, p<.001) with the IM-30 total score.

Conclusion

This study provides support for the reliability and validity of the IM-30 as a measure of clinicians' orientation toward integrative medicine. The IM-30 survey, which we estimate as requiring 5 minutes to complete, can be administered to both conventional and CAM clinicians.

Objective

To assess patients' use of and preferences for information about technical and interpersonal quality when using simulated, computerized health care report cards to select a primary care provider (PCP).

Data Sources/Study Setting

Primary data collected from 304 adult consumers living in Los Angeles County in January and February 2003.

Study Design/Data Collection

We constructed computerized report cards for seven pairs of hypothetical individual PCPs (two internal validity check pairs included). Participants selected the physician that they preferred. A questionnaire collected demographic information and assessed participant attitudes towards different sources of report card information. The relationship between patient characteristics and number of times the participant selected the physician who excelled in technical quality are estimated using an ordered logit model.

Principal Findings

Ninety percent of the sample selected the dominant physician for both validity checks, indicating a level of attention to task comparable with prior studies. When presented with pairs of physicians who varied in technical and interpersonal quality, two-thirds of the sample (95 percent CI: 62, 72 percent) chose the physician who was higher in technical quality at least three out of five times (one-sample binomial test of proportion). Age, gender, and ethnicity were not significant predictors of choosing the physician who was higher in technical quality.

Conclusions

These participants showed a strong preference for physicians of high technical quality when forced to make tradeoffs, but a substantial proportion of the sample preferred physicians of high interpersonal quality. Individual physician report cards should contain ample information in both domains to be most useful to patients.

Objective

To create an efficient imputation algorithm for imputing the SF-12 physical component summary (PCS) and mental component summary (MCS) scores when patients have one to eleven SF-12 items missing.

Study Setting

Primary data collection was performed between 1996 and 1998.

Study Design

Multi-pattern regression was conducted to impute the scores using only available SF-12 items (simple model), and then supplemented by demographics, smoking status and comorbidity (enhanced model) to increase the accuracy. A cut point of missing SF-12 items was determined for using the simple or the enhanced model. The algorithm was validated through simulation.

Data Collection

Thirty-thousand-three-hundred and eight patients from 63 physician groups were surveyed for a quality of care study in 1996, which collected the SF-12 and other information. The patients were classified as “chronic” patients if they reported that they had diabetes, heart disease, asthma/chronic obstructive pulmonary disease, or low back pain. A follow-up survey was conducted in 1998.

Principal Findings

Thirty-one percent of the patients missed at least one SF-12 item. Means of variance of prediction and standard errors of the mean imputed scores increased with the number of missing SF-12 items. Correlations between the observed and the imputed scores derived from the enhanced models were consistently higher than those derived from the simple model and the increments were significant for patients with ≥6 missing SF-12 items (p<.03).

Conclusion

Missing SF-12 items are prevalent and lead to reduced analytical power. Regression-based multi-pattern imputation using the available SF-12 items is efficient and can produce good estimates of the scores. The enhancement from the additional patient information can significantly improve the accuracy of the imputed scores for patients with ≥6 items missing, leading to estimated scores that are as accurate as that of patients with <6 missing items.

Objective. Rheumatologic disorders are associated with sleep disturbances. This study examines sleep disturbance correlates in patients with SSc.

Methods. Participants are 180 SSc patients in an observational study. At baseline, patients completed the Medical Outcomes Study Sleep measure (MOS-Sleep scale). In addition, patients were administered other patient-reported outcome (PRO) measures including the 36-item short form (SF-36), HAQ disability index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Center for Epidemiologic Studies Depression (CESD) scale and a University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Questionnaire (UCLA SCTC GIT 2.0). Descriptive statistics were assessed for six scales of MOS-Sleep and the 9-item sleep problem index (SLP-9; a composite index). We computed Spearman’s rank-order correlations between the MOS-Sleep scales and the HAQ-DI, FACIT-Fatigue, CESD, SSc-SCTC GIT 2.0 and SF-36 scales. In addition, we developed a regression model to assess predictors of SLP-9 scores. Covariates included demographics, physician variables of disease severity and patient-reported variables of worsening symptoms and the PRO measures.

Results. SSc patients reported a mean (s.d.) of 7.1 (1.73) h of sleep a night. Patients reported worse scores on four of six scales (except for snoring and sleep quantity) compared with the US general population (P < 0.001). SLP-9 was correlated with worsening pain and dyspnoea over the past 1 month, reflux scale of the UCLA SCTC GIT 2.0, CESD and FACIT-Fatigue (ρ 0.26–0.56). In the stepwise multivariate regression model, the CESD, worsening dyspnoea and reflux scale were significantly associated with SLP-9 index.

Conclusion. Sleep disturbances are common in SSc and are associated with worsening dyspnoea, depressed mood and severity of reflux symptoms.

Objective

To estimate the reliability and validity of survey measures used to evaluate health plans and providers from the consumer's perspective.

Data Sources

Members (166,074) of 306 U.S. health plans obtained from the National CAHPS® Benchmarking Database 2.0, a voluntary effort in which sponsors of CAHPS® surveys contribute data to a common repository.

Study Design

Members of privately insured health plans serving public and private employers across the United States were surveyed by mail and telephone. Interitem correlations and correlations of items with the composite scores were estimated. Plan-level and internal consistency reliability are estimated. Multivariate associations of composite measures with global ratings are also examined to assess construct validity. Confirmatory factor analysis is used to examine the factor structure of the measure.

Findings

Plan-level reliability of all CAHPS® 2.0 reporting composites is high with the given sample sizes. Fewer than 170 responses per plan would achieve plan-level reliability of .70 for the five composites. Two of the composites display high internal consistency (Cronbach's alpha >=.75), while responses to items in the other three composites were not as internally consistent (Cronbach's alpha from .58 to .62). A five-factor model representing the CAHPS® 2.0 composites fits the data better than alternative two- and three-factor models.

Conclusion

Two of the five CAHPS® 2.0 reporting composites have high internal consistency and plan-level reliability. The other three summary measures were reliable at the plan level and approach acceptable levels of internal consistency. Some of the items that form the CAHPS® 2.0 adult core survey, such as the measure of waiting times in the doctor's office, could be improved. The five-dimension model of consumer assessments best fits the data among the privately insured; therefore, consumer reports using CAHPS® surveys should provide feedback using five composites.

Objective

Consumer assessments of health care provide important information about how well health plans and clinicians meet the needs of the people they serve. The purpose of this study was to examine whether consumer reports and ratings of care in Medicaid managed care vary by race/ethnicity and language.

Data Sources

Data were derived from the National CAHPS ® Benchmarking Database (NCBD) 3.0 and consisted of 49,327 adults enrolled in Medicaid managed care plans in 14 states in 2000.

Data Collection

The CAHPS® data were collected by telephone and mail. Surveys were administered in Spanish and English. The response rate across plans was 38 percent.

Study Design

Data were analyzed using linear regression models. The dependent variables were CAHPS ® 2.0 global rating items (personal doctor, specialist, health care, health plan) and multi-item reports of care (getting needed care, timeliness of care, provider communication, staff helpfulness, plan service). The independent variables were race/ethnicity, language spoken at home (English, Spanish, Other), and survey language (English or Spanish). Survey respondents were assigned to one of nine racial/ethnic categories based on Hispanic ethnicity and race: White, Hispanic/Latino, Black/African American, Asian/Pacific Islanders, American Indian/Alaskan native, American Indian/White, Black/White, Other Multiracial, Other Race/Ethnicity. Whites, Asians, and Hispanics were further classified into language subgroups based on the survey language and based on the language primarily spoken at home. Covariates included gender, age, education, and self-rated health.

Principal Findings

Racial/ethnic and linguistic minorities tended to report worse care than did whites. Linguistic minorities reported worse care than did racial and ethnic minorities.

Conclusions

This study suggests that racial and ethnic minorities and persons with limited English proficiency face barriers to care, despite Medicaid-enabled financial access. Health care organizations should address the observed disparities in access to care for racial/ethnic and linguistic minorities as part of their quality improvement efforts.

Purpose

We assessed cancer survivors' perceptions of the quality of their follow-up care.

Methods

We surveyed a population-based cohort of leukemia, bladder, and colorectal cancer survivors diagnosed 2 to 5 years previously in northern California (N = 623; participation rate, 69.2%; overall response rate, 49.2%). Data were collected between April 2003 and November 2004. Ten scales assessed survivors' perceptions of different aspects of care in the last 12 months, and an eleventh scale measured their overall ratings of care.

Results

On nine of the 11 scales, mean scores ranged from 88 to 97 on a 0 to 100 response format, indicating very positive experiences. The two areas where quality perceptions were lower were discussions about health promotion and the physician's knowledge of the whole patient. In adjusted analyses, those without private health insurance (P = .02) and Hispanic and Asian survivors compared with whites (P < .001) reported worse timeliness of care. Survivors who had multiple comorbidities reported better scores on timeliness of care (P < .01) and physicians' knowledge (P = .05) than survivors without any comorbidity. Length of the patient-physician relationship was the variable most consistently found to be significantly associated with survivors' quality assessments. Physicians' information exchange had the strongest relationship with overall ratings of care, followed by physicians' affective behavior, their knowledge of the survivor, and survivors' perceptions of coordination of care (P < .001 for all).

Conclusion

Delivery of quality follow-up care to cancer survivors may require efforts to improve patient-centered communication and coordination. Special emphasis may need to be placed on health promotion discussions and adoption of a whole-person orientation.

Objectives. SSc-associated gastrointestinal tract involvement (SSc-GIT) is an important predictor of depressive symptoms. University of California at Los Angeles Scleroderma Clinical trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) is a 34-item valid instrument that captures GIT symptom severity and impact on quality of life. It has seven GI-specific scales and a total GIT score. The objectives were to assess: (i) whether there is an association between depressed mood with GI symptom scales as assessed by the UCLA SCTC GIT 2.0 instrument; and (ii) to explore which GI-specific symptom scales are associated with depressed mood in patients with SSc.

Methods. One hundred and fifty-two patients with SSc completed the UCLA SCTC GIT 2.0 and the Center for Epidemiologic Studies Short Depression scale (CES-D10). Patients were divided into depressed (CES-D ≥ 10) or non-depressed group (CES-D < 10) and compared using t-test or chi-square test. Multiple linear regression was used to determine associations between GI scales and depressed mood (CES-D).

Results. Study participants were 84% female, 78% Caucasian and 40% had depressed mood (CES-D10 ≥ 10). Patients with depressed mood had statistically worse GI scale scores (except fecal soilage) and worse total GIT score (P < 0.05). In the multivariable model reflux and constipation scales were independently associated with worse CES-D scores (P = 0.01–0.06)

Conclusion. SSc-GIT involvement is associated with depressed mood. Reflux and constipation scales of UCLA-SCTC GIT 2.0 were independently associated with CES-D. Future studies should assess if treatment of GIT symptoms will improve depressed mood in patients with SSc-GIT.

In recent years, the US FDA has become more critical of instruments used to measure patient-reported outcomes (PROs) in clinical trials. To facilitate decisions related to the approval of drugs, labels and promotional claims based on PROs, the FDA created the Study Endpoints and Label Development (SEALD) group. SEALD has developed a PRO guidance related to the use of PRO measures used to support drug approvals and label claims, including recommendations for establishing thresholds for meaningful change at the individual level (i.e., defining a responder). This article examines in detail the FDA-recommended methodology for defining a responder and analyzing responder-based PRO measure results. We also present other responder analysis approaches for consideration in furthering the precision and interpretation of this methodology.

Aim

Develop a reliable and valid self-report health-related quality of life (HRQOL) instrument for human immunodeficiency virus (HIV)-infected children in Thailand.

Methods

The Thai Quality of Life for HIV-infected Children instrument, the ThQLHC (an HRQOL measure that uses the Pediatric Quality of Life Inventory as a generic core and a 17-item HIV-targeted scale), was developed and administered cross-sectionally to 292 HIV-infected children in Thailand. The disease-targeted scale included HIV-related symptoms, ability to adhere with their treatment regimens and self-image. The internal consistency reliability (Cronbach’s α) and construct validity of the ThQLHC scales were then evaluated.

Results

Internal consistency reliability coefficients ranged from 0.57 to 0.82, with four of five scales reaching the minimal acceptable level (>0.70). Significant associations were found between poor HRQOL and poor self-rated disease severity, care giver’s rated overall quality of life, cluster of differentiation (CD) 4 percent and plasma HIV ribonucleic acid level.

Conclusion

Reliable and valid disease-targeted HRQOL measures for HIV-infected children are essential in the assessment of therapeutic effectiveness. The findings of this cross-sectional survey provide support for the reliability and validity of the ThQLHC as an HRQOL outcome measure for HIV-infected Thai children.

Purpose

To assess diagnostic accuracy of two self-administered depression measures compared to an interviewer-administered measure in subjects with Parkinson's Disease (PD), and to analyze clinical and sociodemographic factors associated with disagreement among the three depression assessment tools.

Methods

We assessed 214 PD subjects using the Patient Health Questionnaire-9 (PHQ-9), the Geriatric Depression Scale-15 (GDS-15), and the Structured Clinical Interview for the DSM-IV depression module (SCID). Diagnostic accuracy of the PHQ-9 and GDS-15 compared to the SCID was evaluated. Multivariate logistic regression was conducted to analyze factors associated with measure disagreement. We compared item agreement between the PHQ-9 and SCID to test the hypothesis that there would be less agreement between items assessing depression symptoms overlapping with common PD symptoms, compared to items having minimal overlap with PD manifestations.

Results

Compared to SCID diagnosis of major depression, PHQ-9 sensitivity is 50% and specificity is 93%; GDS-15 sensitivity is 43% and specificity is 96%. The GDS-15 has 85% sensitivity and 79% specificity and the PHQ-9 has 54% sensitivity and 85% specificity compared to SCID diagnosis of minor or major depression. The PHQ-9 and SCID show more agreement on items unrelated to PD manifestations. Pain was the only factor associated with disagreement between the SCID and PHQ-9.

Conclusion

Compared to the PHQ-9, the GDS-15 had higher sensitivity and similar positive predictive value, suggesting it is a superior screening tool in clinical applications for PD. On future depression screening or diagnostic instruments, consideration should be given to excluding depression items overlapping with PD manifestations.

We assessed degree of Parkinson disease motor symptom improvement with medication among subjects enrolled in an ongoing, population-based study in Central California. The motor section of the unified Parkinson disease rating scale (UPDRS) was performed on subjects in both OFF and ON medication states, and difference between these scores was used as an indicator of symptomatic benefit. Higher OFF minus ON scores correlated with more severe baseline symptoms. There was equivalent improvement on the motor UPDRS scale for subjects divided according to medication classes used: levodopa alone 7.3 points, levodopa plus other medications 8.5 points, and dopamine agonists but not levodopa 6.1 points. In addition, there was no difference in the magnitude of improvement when subjects were divided according to Parkinson disease subtype, defined as tremor dominant, akinetic-rigid, or mixed. In this community-based sample, these values are within the range of a clinically important difference as defined by previous studies.