Validation of the Knee Injury and Osteoarthritis Outcome Score subscales for patients with articular cartilage lesions of the knee.

Background: The Knee Injury and Osteoarthritis Outcome Score (KOOS) assesses acute and chronic knee injuries or early-onset osteoarthritis in young, active patients. The United States Food and Drug Administration guidelines recommend that patient-reported outcome instruments used to support clinical trial label claims should demonstrate content validity using patient input and have acceptable psychometric properties in the target population. To use the KOOS subscales in safety and efficacy trials assessing new treatments for patients with articular cartilage lesions, additional validation work, using input from patients with articular cartilage lesions, was necessary.

Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration.

Purpose: Understand the choice of recall period for PRO measures based on intended use, characteristics of the disease, treatment, and attributes of studies.

Methods: Current practice and considerations were reviewed within several disease areas (overactive bladder, menopausal hot flashes, niacin-induced flushing, osteoarthritis pain, irritable bowel symptoms, benign prostatic hyperplasia, and alopecia).

Results: Rationales were identified for using different recall periods, including event-driven (immediate), daily, up to weekly, and longer than weekly.

Evaluating patient-reported outcome measurement comparability between paper and alternate versions, using the lung function questionnaire as an example.

Objectives: The goal of this study was to provide recommended steps to assess measurement comparability using a crossover study design and to demonstrate these steps using a short patient-reported outcome (PRO) instrument as an example.

Methods: The example PRO instrument was administered via paper, Web, interactive voice response system, and interview; a randomized crossover design was used to gather data across the multiple administration types. Participants completed the PRO instrument, demographic and health questions, and a short preference questionnaire.

Validation of alternate modes of administration of the lung function questionnaire (LFQ) in subjects with smoking history.

Purpose: The lung Function Questionnaire (LFQ) was developed and validated as a case-finding tool to identify patients at risk of airflow obstruction (AO) that should be evaluated further using spirometry. Our objective was to assess the usability and validity of additional questionnaire-administration modes, including Web-based, interactive voice response system (IVRS)-based, and interviewer-based modes.

Design: This multicenter, prospective, noninterventional data-collection study enrolled 149 individuals aged ≥40 years with current or former smoking history.

Development and psychometric properties of the HPV Impact Profile (HIP) to assess the psychosocial burden of HPV.

Objective: A comprehensive questionnaire designed to assess the full spectrum of potential human papillomavirus (HPV)-related psychosocial effects in women does not exist. The HPV Impact Profile (HIP) was developed to determine the psychosocial impact of HPV infection and related interventions.

Research Design And Methods: Draft instrument items and domains were developed using a literature review and cognitive debriefing interviews with women who had experienced HPV-related conditions.

The impact of rotavirus gastroenteritis on the family.

Background: Rotavirus is the leading cause of severe diarrhea in young children and causes substantial morbidity and mortality. Although the clinical aspects have been well described, little information is available regarding the emotional, social, and economic impact of rotavirus gastroenteritis on the family of a sick child. The objectives of this study were to: 1) assess the family impact of rotavirus gastroenteritis through qualitative interviews with parents; 2) compare the clinical severity of rotavirus-positive and negative gastroenteritis; 3) test a questionnaire asking parents to rank the importance of various factors associated with a case of rotavirus gastroenteritis.

Validation of the nighttime symptoms score as a clinically relevant measure of allergic rhinitis.

The aim of this study was to validate the nighttime symptoms score (NSS), which incorporates individual scores for difficulty going to sleep and nighttime awakening caused by nasal symptoms and nasal congestion on awakening, as a clinically relevant measure of allergic rhinitis (AR). Fifty-five general season AR (SAR) symptom items were generated by interviews with 14 patients with symptomatic SAR without concomitant asthma for use in an Importance Rating Questionnaire (IRQ). A second group of patients (n = 83) with symptomatic AR without asthma rated the importance of each item on the IRQ.