Patient-reported outcomes in individuals with hepatitis C virus infection treated with elbasvir/grazoprevir.

Purpose: People chronically infected with hepatitis C virus (HCV) have diminished patient-reported outcomes (PROs). This study aimed to compare the impact of elbasvir/grazoprevir (EBR/GZR) treatment versus sofosbuvir with pegylated interferon and ribavirin (SOF/PR) on changes in PROs: 1) during the treatment period and 2) at posttreatment follow-up.

Patients And Methods: PRO data collected during the Phase III C-EDGE Head-2-Head (H2H) open-label study was analyzed.

Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO.

Background And Purpose: Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version.

Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8-45.

Objectives: The content validity of the 28-item PedsQL™ 3.0 Diabetes Module has not been established in research on pediatric and adult patients with newly diagnosed Type 1 diabetes across a broad age range. This study aimed to document the content validity of three age-specific versions (8-12 years, 13-18 years, and 18-45 years) of the PedsQL™ Diabetes Module in a population of newly diagnosed patients with Type 1 diabetes.

Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder.

Background: Although many symptoms of Major Depressive Disorder (MDD) are assessed through patient-report, there are currently no patient-reported outcome (PRO) instruments that incorporate documented evidence of patient input in PRO instrument development. A review of existing PROs used in MDD suggested the need to conduct qualitative research with patients with MDD to better understand their experience of MDD and develop an evaluative instrument with content validity. The aim of this study was to develop a disease-specific questionnaire to assess symptoms important and relevant to adult MDD patients.

Development of a next day functioning measure to assess the impact of sleep disturbance due to restless legs syndrome: the restless legs syndrome-next day impact questionnaire.

Objectives: Symptoms of Restless Legs Syndrome (RLS) affect patients' quality and duration of sleep, which can have next day sequelae detrimental to daytime performance. To date, no measure sufficiently assesses such sequelae. This study aimed to develop a new self-reported outcome measure to assess the impact of disturbed sleep due to RLS on next day functioning and to support its content validity.

Patients' experiences with cancer-related fatigue: a review and synthesis of qualitative research.

Purpose/objectives: To systematically review published qualitative reports of descriptions of fatigue by patients with cancer and how cancer-related fatigue (CF) affects their lives.

Data Sources: MEDLINE®, CANCERLIT®, Cochrane Database of Systematic Reviews, and the Cumulative Index to Nursing and Allied Health Literature.

Data Synthesis: Two researchers conducted independent reviews of 667 patient quotes found in 154 articles published from 1996-2009 to identify concepts and language used to describe CF.

PRO development: rigorous qualitative research as the crucial foundation.

Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them.

Evaluation of a cancer pain education module.

Purpose/objectives: To assess whether a case-based cancer pain education module would lead to acquisition and retention of knowledge and attitudes at the graduate nursing student level.

Design: Quasi-experimental pretest, post-test, and follow-up.

Setting: Three nursing schools in the New England area.