Psychometric evaluation of the patient-reported experience of cognitive impairment in schizophrenia (PRECIS) scale.

BACKGROUND: Cognitive impairment associated with schizophrenia (CIAS) represents a distinct, persistent, and core group of schizophrenia symptoms. Cognitive symptoms have been shown to have an impact on quality of life. There are several published CIAS measures, but none based on direct patient self-report. It is important to capture the patient's perspective to supplement performancebased outcome measures of cognition to provide a complete picture of the patient's experience. This paper describes additional validation work on the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument. METHODS: Data from two large, international, pharmaceutical clinical trials in medically and psychiatrically stable English-speaking patients with schizophrenia and 88 healthy controls were analyzed. An exploratory factor analysis (EFA) was conducted in one trial (n = 215), using the original 35-item PRECIS. The factor structure suggested by EFA was further evaluated using item response theory (IRT; Samejima's graded response model), and tested using confirmatory factor analysis (CFA). Both EFA and CFA results were tested in a second trial with similar inclusion/exclusion characteristics (n = 410). Additional statistical properties were evaluated in healthy controls. RESULTS: EFA suggested that the best solution after item reduction suggested a factor structure of 6 factors based on 26 items (memory, communication, self-control, executive function, attention, sharpness of thought), supporting a total score, with an additional 2-item bother score (28 items in all). IRT analysis indicated the items were well-ordered within each domain. The CFA demonstrated excellent model fit, accounting for 69% of the variance. The statistical properties of the 28-item version of the PRECIS were confirmed in the second trial. Evidence for internal consistency and test-retest reliability was robust. Known-groups validity was supported by comparison of healthy controls with patients with schizophrenia. Correlations indicated moderate associations between PRECIS and functioning instruments like the Schizophrenia Cognition Rating Scale (SCoRS), but weak correlations with performance-based outcomes like MATRICS Consensus Cognitive Battery (MCCB). DISCUSSION: Using two clinical trial samples, we identified a robust factor structure for the PRECIS and were able to replicate it in the second sample. Evaluation of the meaningful score difference (MSD) should be repeated in future studies, as these samples did not show enough change for it to be evaluated. CONCLUSIONS: This analysis provides strong evidence for the reliability and validity of the PRECIS, a 28-item, patient-reported instrument to assess cognitive impairment associated with schizophrenia. The correlation with functioning and the weak correlation with performance on cognitive tasks suggests that patient reports of cognitive impairment measure a unique aspect of patient experience.

Chronic Airways Assessment Test: psychometric properties in patients with asthma and/or COPD.

BACKGROUND: No short patient-reported outcome (PRO) instruments assess overall health status across different obstructive lung diseases. Thus, the wording of the introduction to the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) was modified to permit use in asthma and/or COPD. This tool is called the Chronic Airways Assessment Test (CAAT). METHODS: The psychometric properties of the CAAT were evaluated using baseline data from the NOVELTY study (NCT02760329) in patients with physician-assigned asthma, asthma + COPD or COPD. Analyses included exploratory/confirmatory factor analyses, differential item functioning and analysis of construct validity. Responses to the CAAT and CAT were compared in patients with asthma + COPD and those with COPD. RESULTS: CAAT items were internally consistent (Cronbach's alpha: > 0.7) within each diagnostic group (n = 510). Models for structural and measurement invariance were strong. Tests of differential item functioning showed small differences between asthma and COPD in individual items, but these were not consistent in direction and had minimal overall impact on the total score. The CAAT and CAT were highly consistent when assessed in all NOVELTY patients who completed both (N = 277, Pearson's correlation coefficient: 0.90). Like the CAT itself, CAAT scores correlated moderately (0.4-0.7) to strongly (> 0.7) with other PRO measures and weakly (< 0.4) with spirometry measures. CONCLUSIONS: CAAT scores appear to reflect the same health impairment across asthma and COPD, making the CAAT an appropriate PRO instrument for patients with asthma and/or COPD. Its brevity makes it suitable for use in clinical studies and routine clinical practice. TRIAL REGISTRATION: NCT02760329.

Development of a Patient-Reported Outcomes Tool to Assess Pain and Discomfort in Autosomal Dominant Polycystic Kidney Disease.

BACKGROUND: Pain has been identified as a core outcome for individuals with autosomal dominant polycystic kidney disease (ADPKD), but no disease-specific pain assessment has been developed using current development methodology for patient-reported outcomes (PRO) instruments. We developed and validated an ADPKD-specific pain questionnaire: the ADPKD Pain and Discomfort Scale (ADPKD-PDS). METHODS: Conceptual underpinnings were drawn from literature review, concept elicitation, expert consultation, and measurement performance. In the qualitative analysis phase, concepts were elicited from focus groups of adults with ADPKD, and the resulting draft instrument was refined using cognitive debriefing interviews with individuals with ADPKD. For quantitative analysis, adults with ADPKD completed the draft instrument and other PRO tools in an online survey, and a follow-up survey was conducted 3-4 weeks later. Survey responses were analyzed for item-level descriptive statistics, latent model fit statistics, item discrimination, item- and domain-level psychometric statistics, test-retest reliability, responsiveness to change, and convergent validity. RESULTS: In the qualitative phase, 46 focus groups were conducted in 18 countries with 293 participants. Focus groups described three conceptually distinct types of ADPKD-related pain and discomfort (dull kidney pain, sharp kidney pain, and fullness/discomfort). In the quantitative phase, 298 adults with ADPKD completed the online survey, and 108 participants completed the follow-up survey. After iterative refinement of the instrument, latent variable measurement models showed very good fit (comparative fit and nonnormed fit indices both 0.99), as did item- and domain-level psychometric characteristics. The final ADPKD-PDS contains 20 items assessing pain severity and interference with activities over a 7-day recall period. CONCLUSIONS: The ADPKD-PDS is the first validated tool for systematically assessing pain and discomfort in ADPKD.

Validity and reliability of global ratings of satisfaction with epilepsy surgery.

OBJECTIVE: We aimed to assess the reliability and validity of single-item global ratings (GR) of satisfaction with epilepsy surgery. METHODS: We recruited 240 patients from four centers in Canada and Sweden who underwent epilepsy surgery ≥1 year earlier. Participants completed a validated questionnaire on satisfaction with epilepsy surgery (the ESSQ-19), plus a single-item GR of satisfaction with epilepsy surgery twice, 4-6 weeks apart. They also completed validated questionnaires on quality of life, depression, health state utilities, epilepsy severity and disability, medical treatment satisfaction and social desirability. Test-retest reliability of the GR was assessed with the intra-class correlation coefficient (ICC). Construct and criterion validity were examined with polyserial correlations between the GR measure of satisfaction and validated questionnaires and with the ESSQ-19 summary score. Non-parametric rank tests evaluated levels of satisfaction, and ROC analysis assessed the ability of GRs to distinguish among clinically different patient groups. RESULTS: Median age and time since surgery were 42 years (IQR 32-54) and 5 years (IQR 2-8), respectively. The GR demonstrated good to excellent test-retest reliability (ICC = 0.76; 95% CI 0.67-0.84) and criterion validity (0.85; 95% CI 0.81-0.89), and moderate correlations in the expected direction with instruments assessing quality of life (0.59; 95% CI 0.51-0.63), health utilities (0.55; 95% CI 0.45-0.65), disability (-0.51; 95% CI -0.41, -0.61), depression (-0.48; 95% CI -0.38, -0.58), and epilepsy severity (-0.48; 95% CI -0.38, -0.58). As expected, correlations were lower for social desirability (0.40; 95% CI 0.28-0.52) and medical treatment satisfaction (0.33; 95% CI 0.21-0.45). The GR distinguished participants who were seizure-free (AUC 0.75; 95% CI 0.67-0.82), depressed (AUC 0.75; 95% CI 0.67-0.83), and self-rated as having more severe epilepsy (AUC 0.78; 95% CI 0.71-0.85) and being more disabled (AUC 0.82; 95% CI 0.74-0.90). SIGNIFICANCE: The GR of epilepsy surgery satisfaction showed good measurement properties, distinguished among clinically different patient groups, and appears well-suited for use in clinical practice and research.

Predicting postoperative epilepsy surgery satisfaction in adults using the 19-item Epilepsy Surgery Satisfaction Questionnaire and machine learning.

OBJECTIVE: The 19-item Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19) is a validated and reliable post hoc means of assessing patient satisfaction with epilepsy surgery. Prediction models building on these data can be used to counsel patients. METHODS: The ESSQ-19 was derived and validated on 229 patients recruited from Canada and Sweden. We isolated 201 (88%) patients with complete clinical data for this analysis. These patients were adults (≥18 years old) who underwent epilepsy surgery 1 year or more prior to answering the questionnaire. We extracted each patient's ESSQ-19 score (scale is 0-100; 100 represents complete satisfaction) and relevant clinical variables that were standardized prior to the analysis. We used machine learning (linear kernel support vector regression [SVR]) to predict satisfaction and assessed performance using the R2 calculated following threefold cross-validation. Model parameters were ranked to infer the importance of each clinical variable to overall satisfaction with epilepsy surgery. RESULTS: Median age was 41 years (interquartile range [IQR] = 32-53), and 116 (57%) were female. Median ESSQ-19 global score was 68 (IQR = 59-75), and median time from surgery was 5.4 years (IQR = 2.0-8.9). Linear kernel SVR performed well following threefold cross-validation, with an R2 of .44 (95% confidence interval = .36-.52). Increasing satisfaction was associated with postoperative self-perceived quality of life, seizure freedom, and reductions in antiseizure medications. Self-perceived epilepsy disability, age, and increasing frequency of seizures that impair awareness were associated with reduced satisfaction. SIGNIFICANCE: Machine learning applied postoperatively to the ESSQ-19 can be used to predict surgical satisfaction. This algorithm, once externally validated, can be used in clinical settings by fixing immutable clinical characteristics and adjusting hypothesized postoperative variables, to counsel patients at an individual level on how satisfied they will be with differing surgical outcomes.

Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD.

Background: The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD). Methods: Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (ClinicalTrials.gov: NCT02760329). The total sample (n=1530) comprised three randomly selected samples (n=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD and COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses. Results: For the total sample, the mean±sd RSQ score was 5.6±4.3 (range 0-16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's α=0.76-0.80). All items had high factor loadings and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the θ score range of -2.0 to 2.8, with discrimination coefficients for individual items being high to very high (1.7-2.6). Strong convergent correlations were observed between the RSQ and the St George's Respiratory Questionnaire (0.77, p<0.001). Conclusions: The RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies.

Development and validation of the Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19).

OBJECTIVE: No validated tools exist to assess satisfaction with epilepsy surgery. We aimed to develop and validate a new measure of patient satisfaction with epilepsy surgery, the 19-item Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19). METHODS: An initial 31-item measure was developed based on literature review, patient focus groups, thematic analysis, and Delphi panels. The questionnaire was administered twice, 4-6 weeks apart, to 229 adults (≥18 years old) who underwent epilepsy surgery ≥1 year earlier, at three centers in Canada and one in Sweden. Participants also completed seven validated questionnaires to assess construct validity. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) assessed the factorial structure of the questionnaire. Cronbach alpha and intraclass correlation coefficients (ICCs) assessed the internal consistency and test-retest reliability of the ESSQ-19. Spearman and polyserial correlations assessed construct validity. RESULTS: Median age of participants and time since surgery were 42 years (interquartile range [IQR] = 32-54) and 5 years (IQR = 2-8.75), respectively. EFA and CFA yielded 18 items that segregated into four domains (mean score [SD]), namely, seizure control (76.4 [25]), psychosocial functioning (67.3 [26]), surgical complications (84 [22]), and recovery from surgery (73 [24]), one global satisfaction item, and a summary global score (74 [21]). The domain and summary scores demonstrated good to excellent internal reliability (Cronbach ⍺ range = .84-.95) and test-retest reliability (ICC range = 0.71-0.85). Construct validity was supported by predicted correlations with other instruments. SIGNIFICANCE: The ESSQ-19 is a new, valid, and reliable measure of patient satisfaction with epilepsy surgery that can be used in clinical and research settings.

Patient satisfaction with epilepsy surgery: what is important to patients?

Patient satisfaction with therapeutic interventions is an important outcome of care. Although generic measures of patient satisfaction exist, there is no validated scale for measuring patient satisfaction with epilepsy surgery. We aimed to systematically obtain patient-identified factors related to satisfaction with epilepsy surgery as a means of informing clinicians about the ways that patients evaluate outcomes of their treatment and as a conceptual basis for the future development of epilepsy surgery patient satisfaction scales. Focus group discussions with epilepsy surgery patients (n=9) were conducted to identify themes relevant to patient satisfaction with epilepsy surgery and to draft initial items of importance. Consensus methodology (Delphi technique) was used to obtain expert opinion (n=13) to refine the items. Member-checking with focus group participants was performed to ensure the identified items were relevant, clear, and inclusive. A list of 31 items embodied 12 themes related to patient-reported satisfaction with epilepsy surgery. These included adverse effects, medical care or rehabilitation, seizure control, post-operative recovery, anti-seizure medication, independence, seizure worry, ability to drive, social relationships, self-confidence, improved cognitive function, and improved physical health. This study used a systematic approach to identify factors that are important to patients when assessing satisfaction with epilepsy surgery. This knowledge can assist clinicians caring for these patients and is also a critical step towards the validation of a formal scale to assess satisfaction with epilepsy surgery.

TOMMORROW neuropsychological battery: German language validation and normative study.

INTRODUCTION: Assessment of preclinical Alzheimer's disease (AD) requires reliable and validated methods to detect subtle cognitive changes. The battery of standardized cognitive assessments that is used for diagnostic criteria for mild cognitive impairment due to AD in the TOMMORROW study have only been fully validated in English-speaking countries. We conducted a validation and normative study of the German language version of the TOMMORROW neuropsychological test battery, which tests episodic memory, language, visuospatial ability, executive function, and attention. METHODS: German-speaking cognitively healthy controls (NCs) and subjects with AD were recruited from a memory clinic at a Swiss medical center. Construct validity, test-retest, and alternate form reliability were assessed in NCs. Criterion and discriminant validities of the cognitive measures were tested using logistic regression and discriminant analysis. Cross-cultural equivalency of performance of the German language tests was compared with English language tests. RESULTS: A total of 198 NCs and 25 subjects with AD (aged 65-88 years) were analyzed. All German language tests discriminated NCs from persons with AD. Episodic memory tests had the highest potential to discriminate with almost twice the predictive power of any other domain. Test-retest reliability of the test battery was adequate, and alternate form reliability for episodic memory tests was supported. For most tests, age was a significant predictor of group effect sizes; therefore, normative data were stratified by age. Validity and reliability results were similar to those in the published US cognitive testing literature. DISCUSSION: This study establishes the reliability and validity of the German language TOMMORROW test battery, which performed similarly to the English language tests. Some variations in test performance underscore the importance of regional normative values. The German language battery and normative data will improve the precision of measuring cognition and diagnosing incident mild cognitive impairment due to AD in clinical settings in German-speaking countries.

Developing culturally congruent weight maintenance programs for African American church members.

OBJECTIVES: Developing community-based and culturally congruent weight loss maintenance programs is an important component of weight reduction interventions in high-risk populations. This qualitative investigation was conducted to guide development of faith-based weight maintenance programs for African American church members. DESIGN: Twenty African American church members who previously participated in a church-based group weight loss program were recruited to participate in focus groups. This qualitative inquiry focused on the role of faith in maintaining healthy lifestyle behaviors, such as healthy eating and regular physical activity. Within these groups, a nominal group process was used to identify activities and language to be included within a faith-based maintenance program. RESULTS: Content analysis identified seven conceptual domains that participants thought were important aspects of a faith-based weight maintenance program: (1) accountability for change targets, (2) programmatic tools, (3) group benefits and support, (4) keys to successful behavior change, (5) keys to church and programmatic level success, (6) addressing barriers, and (7) faith. The faith sub-domains included faith in the Lord, using the body for God, and a spiritual focus. The nominal group process resulted in 11 recommended components for a faith-based weight maintenance program. The top four included scriptures and prayers are 'walk of faith,' healthy diet, exercise, and focusing on God. CONCLUSIONS: The results suggest that integrating faith themes into a weight loss maintenance program may increase its long-term impact on participants' health behavior change.

A qualitative investigation of visual tasks with which to assess distance-specific visual function.

BACKGROUND: The ability to perform many daily tasks relies on good visual acuity at various distances. A review of existing measures of visual function revealed gaps in task content, particularly tasks that rely on intermediate vision. PURPOSE: This research sought to extend the content base and visual range coverage of tasks used to assess visual function. METHODS: Ophthalmology patients (n = 72) with myopia, hyperopia, presbyopia, astigmatism, cataracts, and/or glaucoma were involved in various qualitative sub-studies, including life event journaling, telephone interviews, and both on-line and face-to-face focus groups. The resulting journal entries and transcripts were thematically analyzed to identify visual tasks that rely on visual acuity in the near, intermediate, and distant visual ranges. RESULTS: A wide variety of distance-specific visual tasks were identified. Certain types of tasks relied on distance vision, such as; ambulation, driving, leisure and sports, and social functions. Other task groupings such as technology use and activities of daily living relied primarily on near and intermediate vision. Two new content areas were identified, technology use and safe task performance. CONCLUSIONS: This thematic analysis provides a rich body of information about tasks that affect daily life and are made more difficult by poor visual acuity at various distance ranges.

Economic burden of ventilator-associated pneumonia based on total resource utilization.

OBJECTIVES: To characterize the current economic burden of ventilator-associated pneumonia (VAP) and to determine which services increase the cost of VAP in North American hospitals. DESIGN AND SETTING: We performed a retrospective, matched cohort analysis of mechanically ventilated patients enrolled in the North American Silver-Coated Endotracheal Tube (NASCENT) study, a prospective, randomized study conducted from 2002 to 2006 in 54 medical centers, including 45 teaching institutions (83.3%). METHODS: Case patients with microbiologically confirmed VAP (n = 30)were identified from 542 study participants with claims data and were matched by use of a primary diagnostic code, and subsequently by the Acute Physiology and Chronic Health Evaluation II score, to control patients without VAP (n = 90). Costs were estimated by applying hospital-specific cost-to-charge ratios based on all-payer inpatient costs associated with VAP diagnosis-related groups. RESULTS: Median total charges per patient were $198,200 for case patients and $96,540 for matched control patients (P < .001); corresponding median hospital costs were $76,730 for case patients and $41,250 for control patients (P = .001). After adjusting for diagnosis-related group payments, median losses to hospitals were $32,140 for case patients and $19,360 for control patients (P = .151). The median duration of intubation was longer for case patients than for control patients (10.1 days vs 4.7 days; P < .001), as were the median duration of intensive care unit stay (18.5 days vs 8.0 days; P < .001) and the median duration of hospitalization (26.5 days vs 14.0 days; P < .001). Examples of services likely to be directly related to VAP and having higher median costs for case patients were hospital care (P < .05) and respiratory therapy (P < .05). CONCLUSIONS: VAP was associated with increased hospital costs, longer duration of hospital stay, and a higher number of hospital services being affected, which underscores the need for bundled measures to prevent VAP. TRIAL REGISTRATION: NASCENT study ClinicalTrials.gov Identifier: NCT00148642.

Rapid diagnostic testing for seasonal influenza: an evidence-based review and comparison with unaided clinical diagnosis.

BACKGROUND: Worldwide, seasonal influenza imposes a considerable health and economic burden. Clinical diagnosis of influenza-like illness (ILI) is complicated by non-specific symptomatology. Rapid flu tests (RFTs) impact treatment decisions and may improve patient care; yet, recommendations for RFT use are broad, and the performance of unaided clinical diagnosis relative to RFTs is unclear. OBJECTIVES: To determine age-stratified, overall sensitivities and specificities of the widely studied RFT, QuickVue® (Quidel Corporation, San Diego, CA), and clinical diagnosis of ILI by meta-analysis and to seek factors associated with poorer clinical diagnostic discrimination. METHODS: A systematic literature review was conducted using article selection criteria identifying studies indexed in PubMed/MEDLINE, the Cochrane Library, and other pertinent sources of studies reporting sensitivity, specificity, and effects of RFTs and clinical diagnosis on decision-making for patients with ILI. RESULTS: QuickVue's® diagnostic specificity exceeds that of unaided clinical diagnosis by 29-31%. False-positive results occur approximately 8.2 times more frequently by unaided clinical diagnosis than by the RFT alone. These findings were unaffected by seasonal variations in disease prevalence. RFTs reduce diagnostic testing, antibiotic use, and emergency department utilization while increasing antiviral prescription rates. No systematic relationship between the broadness of clinical diagnostic criteria for influenza and diagnostic performance was observed across studies included in this review. CONCLUSIONS: Use of RFTs improves seasonal influenza diagnostic specificity above that based on unaided clinical diagnosis irrespective of the broadness of clinical diagnostic criteria, and affects clinical decision-making. These results provide an improved framework upon which to diagnose influenza, design future RFT studies, and modify existing recommendations for improved ILI patient management.

An evidence-based review of treatment-related determinants of patients' nonadherence to HIV medications.

Patients' adherence to antiretroviral medications is a primary determinant of both the effectiveness of treatment and the clinical course of HIV/AIDS. This empirical review is intended to compare the relative importance of patient and treatment characteristics on nonadherence behavior and the impact of nonadherence on treatment failure. Articles cited in PubMed and published between 2006 and June 2008 (n = 200) were reviewed to select those that address patient or treatment characteristics associated with nonadherence. Twenty-two articles were selected that provided odds ratio or hazard ratio statistics that quantified predictors of patients' level of nonadherence (e.g., <80%, 80%-95% and >95%). Results were summarized using random effects meta-analytic models. Predictors of nonadherence were divided into four predictive clusters (clinical predictors, comorbid predictors, treatment competence predictors, and dosing predictors). The summary odds ratios (ORs) of nonadherence for each cluster (in order of strength) were treatment competence 2.0 (95% confidence interval [CI]: 1.6-2.6), clinical predictors 1.6 (95% CI: 1.4-1.8), comorbid predictors 1.6 (95% CI: 1.4-1.8), and dosing predictors 1.5 (95% CI: 1.3-1.7). The effect of nonadherence on treatment failure supported the findings of two prior empirical reviews (OR 2.0, 95% CI: 1.6-2.5). Within dosing predictors, a pill burden of more versus less than 10 pills per day was associated with a much higher odds of nonadherence than twice versus once daily dosing or small differences in the number of types of antiretroviral treatments in a regimen. These results provide insight into the relative importance of various determinants of patient nonadherence that may inform the design of patient educational initiatives and initiatives to simplify treatment regimens.

A qualitative inquiry into the community and programmatic dimensions associated with successful implementation of church-based diabetes prevention programs.

PURPOSE: This study explored church members' perspectives regarding implementation of a church-based diabetes prevention program (CBDPP) within African American churches. METHODS: Qualitative exploration of themes associated with planning for program implementation and good program outcomes was conducted using a series of four focus groups in churches located in the southeastern United States. Three of these focus groups were conducted with church leaders during the planning phases of program initiation and one focus group involved program participants who had realized the most weight loss and decrease in fasting glucose. Focus group transcripts were subject to content analysis. Participants discussed their views about how to implement a CBDPP within their church and how both the program and broader church community had helped them succeed. RESULTS: Two broad thematic domains emerged with respect to successful CBDPP implementation. The first domain covered church functions and program integration within the church. This was further divided into three thematic clusters relating to church organization, promotion from the pulpit and program visibility, and church service. The second domain addressed the motivational and relationship factors associated with successful program involvement. This was divided into three clusters relating to individuals' motives and beliefs, learning from others, and the support of others. CONCLUSIONS: Implementation of a CBDPP depends on the endorsement by the church leadership, congregational awareness of the program objectives, and active community and program support of CBDPP participants. These occur through a variety of formal and informal channels within the church community.

Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications.

BACKGROUND: The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 is a reliable and valid instrument to assess patients' satisfaction with medication, providing scores on four scales--side effects, effectiveness, convenience and global satisfaction. In naturalistic studies, administering the TSQM with the side effects domain could provoke the physician to assess the presence or absence of adverse events in a way that is clinically atypical, carrying the potential to interfere with routine medical care. As a result, an abbreviated 9-item TSQM (TSQM-9), derived from the TSQM Version 1.4 but without the five items of the side effects domain was created. In this study, an interactive voice response system (IVRS)-administered TSQM-9 was psychometrically evaluated among patients taking antihypertensive medication. METHODS: A total of 3,387 subjects were invited to participate in the study from an online panel who self-reported taking a prescribed antihypertensive medication. The subjects were asked to complete the IVRS-administered TSQM-9 at the start of the study, along with the modified Morisky scale, and again within 7 to 14 days. Standard psychometric analyses were conducted; including Cronbach's alpha, intraclass correlation coefficients, structural equation modeling, Spearman correlation coefficients and analysis of covariance (ANCOVA). RESULTS: A total of 396 subjects completed all the study procedures. Approximately 50% subjects were male with a good racial/ethnic mix: 58.3% white, 18.9% black, 17.7% Hispanic and 5.1% either Asian or other. There was evidence of construct validity of the TSQM-9 based on the structural equation modeling findings of the observed data fitting the Decisional Balance Model of Treatment Satisfaction even without the side effects domain. TSQM-9 domains had high internal consistency as evident from Cronbach's alpha values of 0.84 and greater. TSQM-9 domains also demonstrated good test-retest reliability with high intraclass correlation coefficients exceeding 0.70. As expected, the TSQM-9 domains were able to differentiate between individuals who were low, medium and high compliers of medication, with moderate to high effect sizes. There was evidence of convergent validity with significant correlations with the medication adherence scale. CONCLUSION: The IVRS-administered TSQM-9 was found to be a reliable and valid measure to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care.

Patient experiences with oily skin: the qualitative development of content for two new patient reported outcome questionnaires.

OBJECTIVE: To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. METHODS: Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. RESULTS: There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. CONCLUSION: The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures reported elsewhere.

Addressing ceiling effects in health status measures: a comparison of techniques applied to measures for people with HIV disease.

OBJECTIVES: To compare different approaches to address ceiling effects when predicting EQ-5D index scores from the 10 subscales of the MOS-HIV Health Survey. STUDY DESIGN: Data were collected from an HIV treatment trial. Statistical methods included ordinary least squares (OLS) regression, the censored least absolute deviations (CLAD) approach, a standard two-part model (TPM), a TPM with a log-transformed EQ-5D index, and a latent class model (LCM). Predictive accuracy was evaluated using percentage of absolute error (R(1)) and squared error (R(2)) predicted by statistical methods. FINDINGS: A TPM with a log-transformed EQ-5D index performed best on R(1); a LCM performed best on R(2). In contrast, the CLAD was worst. Performance of the OLS and a standard TPM were intermediate. Values for R(1) ranged from 0.33 (CLAD) to 0.42 (TPM-L); R(2) ranged from 0.37 (CLAD) to 0.53 (LCM). CONCLUSIONS: The LCM and TPM with a log-transformed dependent variable are superior to other approaches in handling data with ceiling effects.

The association of consumer expectations, experiences and satisfaction with newly prescribed medications.

OBJECTIVE: To examine the association between medication expectations and subsequent experience on treatment satisfaction and intention to continue using the medication. METHODS: A longitudinal study with two surveys administered to each patient. Patients prescribed a new medication were recruited in pharmacies within Michigan. Medication-related expectations were evaluated at baseline. Experiences, satisfaction and intent to continue were evaluated a month later. Analyses used included factorial ANOVA models, multiple linear regressions and structural equation modeling (SEM). Impact of satisfaction on intention to continue was evaluated using correlation analysis and SEM. RESULTS: A total of 344 usable responses were obtained. SEM showed that expectation scores were not associated with both experience (path coefficient = 0.10) and satisfaction (path coefficient = 0.02, NS). On the other hand, experience was strongly associated with satisfaction (path coefficient = 0.89) and satisfaction was strongly associated with intent to continue using the new medication (path coefficient = 0.81). CONCLUSIONS: This study empirically supports the value of the patient's experience and its contribution to satisfaction, which in turn is associated with intended continued use mainly due to greater effectiveness of the newly prescribed medication. Satisfied consumers should be more adherent, thus enhancing the probability of positive therapeutic outcomes.

US and UK versions of the EQ-5D preference weights: does choice of preference weights make a difference?

BACKGROUND: Most US studies that estimate EQ-5D index score generally apply the UK preference weights. We compared the validity of a newly-developed US weights to the UK weights for use of EQ-5D as a measure of health-related quality of life. METHODS: Data were collected from a randomized clinical trial for patients with HIV (n = 1,126) in the US. Convergent validity was examined by comparing Pearson correlations of EQ-5D index scores with the MOS-HIV Health Survey scale scores and Physical and Mental Health Summary (PHS, MHS) scores using the US and UK weights. Known-groups validity of EQ-5D US versus UK index scores was compared using clinical variables (CD4+ cell count and HIV viral load), and the MOS-HIV PHS and MHS. Score changes in the EQ-5D index from baseline to week 50 were examined using effect size (ES) estimates. RESULTS: The mean EQ-5D index scores was slightly higher using US weights than UK weights (0.87 vs. 0.84, respectively). The correlation coefficient for EQ-5D utilities using the US and UK weights was 0.98. The correlations of EQ-5D index scores with the MOS-HIV scores were moderate and similar using the US and UK weights. The EQ-5D index scores discriminated equally well for both versions between levels of CD4+ count, HIV viral load, and PHS and MHS scores (P < 0.05), suggesting equivalent known-groups validity. The changes in EQ-5D index scores from baseline to week 50 were similar for both versions (ES: 0.21 vs. 0.22 for US and UK, respectively), suggesting equivalent responsiveness to score changes. CONCLUSIONS: EQ-5D index scores generated using UK and US preference weights showed equivalent psychometric properties. For assessing treatment benefit in a single population, the use of either the UK or US weights as a measure of HRQOL will not change inferences. However, for comparisons across US and UK populations, the choice between these two weights should be based on their relevance to the study population.