39 Result(s)
within
Kathleen W. Wyrwich
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Article
The challenges inherent with anchor-based approaches to the interpretation of important change in clinical outcome assessments
Anchor-based methods are group-level approaches used to derive clinical outcome assessment (COA) interpretation thresholds of meaningful within-patient change over time for understanding impacts of disease and...
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Article
Using qualitative methods to establish the clinically meaningful threshold for treatment success in alopecia areata
Traditionally, appropriate anchors are used to investigate the amount of change on a clinician-reported outcome assessment that is meaningful to individual patients. However, novel qualitative methods involvin...
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Article
Open AccessA Qualitative Study to Develop and Evaluate the Content Validity of the Vitiligo Patient Priority Outcome (ViPPO) Measures
Vitiligo can be associated with a psychological burden, stigmatization and impaired quality of life. Tools to assess the impact of vitiligo exist; however, none were developed in line with the FDA’s patient-re...
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Article
Open AccessMeaningful Changes in What Matters to Individuals with Vitiligo: Content Validity and Meaningful Change Thresholds of the Vitiligo Area Scoring Index (VASI)
This study explored patients’ and dermatologists’ priority outcomes for treatment to address, clinical outcome assessments (COA) for use in vitiligo clinical trials, and perceptions of within-patient meaningfu...
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Article
Open AccessKey measurement concepts and appropriate clinical outcome assessments in pediatric achondroplasia clinical trials
This study aimed to identify fit-for-purpose clinical outcome assessments (COAs) to evaluate physical function, as well as social and emotional well-being in clinical trials enrolling a pediatric population wi...
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Article
Open AccessCorrection to: Validation of the Alopecia Areata Patient Priority Outcomes (AAPPO) Questionnaire in Adults and Adolescents with Alopecia Areata
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Article
Open AccessValidation of the Alopecia Areata Patient Priority Outcomes (AAPPO) Questionnaire in Adults and Adolescents with Alopecia Areata
Individuals with alopecia areata (AA) may experience significant impacts on their health-related quality of life. The novel Alopecia Areata Patient Priority Outcomes (AAPPO) questionnaire has been developed to...
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Article
Open AccessDevelopment of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata
Eyebrow and eyelash hair loss and nail damage—in addition to scalp hair loss—are important signs/symptoms of alopecia areata (AA) to patients and deserve assessment in AA clinical trials.
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Article
Open Access“‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata
Alopecia areata (AA) is characterized by hair loss that can affect the scalp and body. This study describes the psychosocial burden of AA.
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Article
Open AccessExploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis
Atopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQ...
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Article
Open AccessContent validity of the Migraine-Specific Quality of Life Questionnaire version 2.1 electronic patient-reported outcome
A concept elicitation, cognitive debriefing, and usability study was undertaken to: 1) ascertain the migraine experience with a particular focus on the impact on roles and daily functioning; 2) determine the c...
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Article
Open AccessPsychometric properties of the single-item measure, severity of worst tiredness, in patients with moderately to severely active rheumatoid arthritis
To assess the reliability, validity, and responsiveness to treatment change of the single-item measure, Severity of Worst Tiredness, in patients with rheumatoid arthritis (RA).
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Article
Open AccessPsychometric properties of morning joint stiffness duration and severity measures in patients with moderately to severely active rheumatoid arthritis
To assess the measurement properties of two single-item patient-reported outcome (PRO) measures that assessed the length of time (in minutes) and severity of morning joint stiffness (MJS) experienced each day.
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Article
Open AccessThe direct and indirect effects of lurasidone monotherapy on functional improvement among patients with bipolar depression: results from a randomized placebo-controlled trial
Bipolar depression is characterized by depressive symptoms and impairment in many areas of functioning, including work, family, and social life. The objective of this study was to assess the independent, direc...
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Reference Work Entry In depth
Patient-Centered Comparative Effectiveness Research
Dating back to the early Greek philosophers, medical practice and the role of healers have oscillated between theories where (1) the classification of disease serves as the basis for the subsequent approach to...
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Living Reference Work Entry In depth
Patient-Centred Comparative Effectiveness Research
Dating back to the early Greek philosophers, medical practice and the role of healers have oscillated between theories where (1) the classification of disease serves as the basis for the subsequent approach to...
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Article
Is Rasch model analysis applicable in small sample size pilot studies for assessing item characteristics? An example using PROMIS pain behavior item bank data
Large samples are generally considered necessary for Rasch model to obtain robust item parameter estimates. Recently, small sample Rasch analysis was suggested as preliminary assessment of items’ psychometric ...
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Article
ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research
An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate intervent...
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Article
Community-Acquired Pneumonia: Symptoms and Burden of Illness at Diagnosis among US Adults Aged 50 Years and Older
Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality in older adults, yet few studies have comprehensively measured the burden of CAP symptoms and their impact from the patient pers...
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Article
Open AccessThe Fatigue Associated with Depression Questionnaire (FAsD): responsiveness and responder definition
The Fatigue Associated with Depression Questionnaire (FAsD) was developed to assess fatigue and its impact among patients with depression. The purpose of this study was to examine the questionnaire’s responsiv...
