Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.

BACKGROUND: To better understand symptoms experienced by patients infected with chronic hepatitis C virus (HCV), valid and reliable patient-reported outcome (PRO) measures are needed. AIM: To assess the reliability and validity of 10 patient-reported outcomes measurement information system (PROMIS) measures and the Headache Impact Test-6 (HIT-6) in a large national sample of patients with HCV. METHODS: Pre-treatment data from 961 patients with HCV starting direct acting antiviral therapy at 11 U.S. liver centers were analyzed. Internal reliability was evaluated using Cronbach's alpha coefficient; frequency distributions were examined for floor and ceiling effects; structural validity was investigated via item-response-theory models; convergent validity was evaluated using correlations with theoretically-similar items from the HCV-PRO and memorial symptom assessment scale (MSAS); and known-groups validity was investigated by observing PRO differences by liver disease status and number of comorbidities. RESULTS: The HIT-6 and the majority of the PROMIS measures yielded excellent reliability (alphas ≥ 0.87). Ceiling effects were infrequent ( < 4%), while 30%-59% of patients reported no symptoms (floor effects). The data supported structural validity of the HIT-6 and most PROMIS measures. The PROMIS measures showed moderate to strong correlations with theoretically-similar items from the HCV-PRO and MSAS (0.39-0.77). Trends were observed between worse PRO scores and advanced cirrhosis and greater number of comorbidities, lending support for known-groups validity. CONCLUSIONS: The psychometric properties of the HIT-6 and PROMIS measures performed satisfactorily in this large cohort of patients with HCV starting direct acting antiviral therapy. Opportunities exist for further refinement of these PROs. Evaluation of performance over time and in under-represented subgroups is needed.

Characterization of nonrapid virologic response patients infected with HCV genotype 1 who may relapse after standard therapy with peginterferon plus ribavirin.

Approximately 50% of patients with hepatitis C virus (HCV) genotype 1 treated with peginterferon alfa-2a/ribavirin discontinue treatment early or experience a suboptimal response despite 48 weeks of therapy. The objective of this analysis was to develop a model to identify nonrapid virologic response (non-RVR) patients who may be candidates for intensified therapy that would increase treatment response. The retrospective analysis included non-RVR patients from four trials of 48-week peginterferon alfa-2a/ribavirin treatment. Patients were grouped into those who cleared virus between weeks 5 and 12 (complete early virologic responders, cEVR) or between weeks 13 and 24 (slow responders). A model was developed to predict relapse at the end of follow-up (week 72). An optimal model was evaluated and compared with current practice by using receiver operating characteristic curves, sensitivity and specificity. In total, 539 non-RVR patients were eligible for analysis of which 72% experienced cEVR and 28% were slow responders. Variables associated with relapse included age, ethnicity, baseline HCV RNA and interval of time to HCV RNA undetectable. The optimal model was most accurate at predicting patients at risk for relapse. The practice of considering treatment intensification (e.g. extending treatment duration) in all slow responders was less accurate but likely most practical. A week 4 HCV <2-log reduction was the earliest but least accurate marker. We developed a model that could identify non-RVR patients at high risk for relapse after 48 weeks of peginterferon alfa-2a plus ribavirin and who may benefit from intensified therapy to reduce this risk of relapse.

Infant and toddler feeding patterns and problems: normative data and a new direction. Pediatric Practice Research Group.

To fill information gaps, predominantly non-Hispanic white parents in five Chicago-area pediatric offices were surveyed concerning infant (n = 130) and toddler (n = 151) feeding times and behaviors. Feeding time distributions did not differ by age. Percentiles (in minutes) were: 10th, 9.4; 50th, 17.7; and 90th, 29.3. The most common infant problematic feeding behavior (PFB) was "not always hungry at mealtime" (33%). Toddler PFB included "not always hungry at mealtime" (52%), "trying to end meals after a few bites" (42%), "picky eating" (35%), and strong food preferences (33%). Toddler picky eaters ate more slowly (means 23.3 vs 19.7 minutes, p < .04). Toddlers with recalled PFB at 6 and 12 months ate most slowly (mean 37.5 minutes). We conclude that: (1) infants and toddlers who take >30 minutes to feed are slow feeders; (2) reports of behavioral feeding problems are common in toddlers and are related to slow feeding; (3) and these data can guide clinical care and future studies.