Sheri E. Fehnel

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Because depressed patients commonly experience reductions in motivation and energy, both as symptoms of their disorder and as side effects of pharmacotherapy, it is important to identify interventions that can restore their vitality. The Motivation and Energy Inventory (MEI) was recently developed to facilitate the evaluation of such efforts both in(More)
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(More)
The psychometric properties of the Brief Pain Inventory (BPI), a widely used measure of pain and its impact on functioning, were assessed using data from two clinical trials of controlled-release oxycodone in osteoarthritis (OA) patients. Specifically, the pain-related functional interference subscale and the sleep item from that subscale were examined. In(More)
BACKGROUND The Diabetic Foot Ulcer Scale (DFS) provides comprehensive measurement of the impact of diabetic foot ulcers on patients' QOL through self-administration of 64 items comprising 15 subscales. OBJECTIVE To develop and evaluate a short form of the DFS (DFS-SF) to reduce patient burden and the number of outcome measures, and to improve sensitivity(More)
Two experiments examined the role of cognitive inflexibility and reduced working memory in age-related declines on the Wisconsin Card Sorting Test. Both standard scoring procedures and newly developed scores were used to measure each construct, and modifications of the test further evaluated the role of working memory. Results indicated that age differences(More)
The objective of this study was to assess specific areas of life in which obesity affects individuals with type 2 diabetes mellitus (T2DM), and changes that obese persons with T2DM experience with weight loss of varying degrees. Thirty in-depth interviews were conducted in persons identified as: age ≥40 years, diagnosed with T2DM for ≥2 years, on oral(More)
BACKGROUND Fast-acting anxiolytics are important to patients and society. Measuring early onset, however, requires a sensitive and clinically responsive measure. This study develops and evaluates the psychometric properties of a new patient-reported instrument, the Daily Assessment of Symptoms - Anxiety (DAS-A), designed to detect reduction of anxiety(More)
OBJECTIVE To describe characteristics of vasomotor symptoms, specifically daily frequency and severity, among women 40-65 years old in the United States (US). DESIGN A survey was completed by a nationally representative sample of 4402 US women aged 40-65 years old. A questionnaire focusing on menopausal symptoms was administered online in April 2005. (More)
BACKGROUND & AIMS There is debate about how best to measure patient-reported outcomes (PROs) in irritable bowel syndrome (IBS). We pooled data to measure the psychometric properties of IBS end points, including binary responses (eg, "adequate relief") and 50% improvement in symptom severity. METHODS We pooled data from 12 IBS drug trials involving 10,066(More)
OBJECTIVE To better understand depression's impact on family functioning from the perspectives of patients with major depressive disorder (MDD) and their partners; to develop and test patient and partner versions of a new self-reported measure, the Depression and Family Functioning Scale (DFFS), for use in clinical trials. METHODS Concept elicitation(More)