Validation of the Physician's Global Assessment of Fingernail Psoriasis by Rheumatologists Treating Psoriatic Arthritis.

OBJECTIVES: This study aimed to assess the content validity and reliability of the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) by rheumatologists treating patients with psoriatic arthritis. METHODS: There were 3 stages of analyses with 3 clinician cohort groups. Stage 1 (concept confirmation) included rheumatologist qualitative data (cohort 1) to establish content validity, acceptability, utility, and feasibility of the PGA-F in assessing nail severity. Quantitative information regarding the response category utilization in nail abnormalities was assessed by photographs. Stage 2 (inter-rater reliability) involved quantitative analysis of PGA-F data from study investigators, including rheumatologists, involved in a phase III clinical study (cohort 2) and a cohort of newly recruited rheumatologists (cohort 3). Stage 3 included known-groups validity. RESULTS: Qualitative analyses identified consensus that the PGA-F severity levels are comprehensive of real-world patient symptoms and the instrument is simple to use and understand. Psychometric analyses support the PGA-F as a clinical outcome assessment tool. Inter-rater reliability showed rheumatologist agreement across the fingernail psoriasis severity spectrum. They were monotonically ordered by the hypothesized severity structure with excellent fit to the clinicians who evaluated them. Agreement on the rank order of the severity of the photographs in this target rheumatologist population was consistent with previous reports by dermatologists. CONCLUSIONS: The PGA-F was shown to be usable by rheumatologists to measure patients along the full range of the fingernail psoriasis severity spectrum, have a strong relationship with a conceptually similar reference measure, differentiate among patients based on fingernail psoriasis severity, and detect category severity change over a 24-week period.

Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis.

BACKGROUND: Patients with Crohn's disease (CD) or ulcerative colitis (UC) frequently experience fatigue, although it is often overlooked in medical research and practice. AIMS: To explore patients' experience of fatigue and evaluate content validity, psychometric properties, and score interpretability of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in patients with CD or UC. METHODS: Concept elicitation and cognitive interviews were conducted with participants aged ≥ 15 years with moderately-to-severely active CD (N = 30) or UC (N = 33). To evaluate psychometric properties (reliability and construct validity) and interpretation of FACIT-Fatigue scores, data from two clinical trials were analyzed [ADVANCE (CD): N = 850; U-ACHIEVE (UC): 248]. Meaningful within-person change was estimated using anchor-based methods. RESULTS: Almost all interview participants reported experiencing fatigue. Over 30 unique fatigue-related impacts were reported per condition. The FACIT-Fatigue was interpretable for most patients. FACIT-Fatigue items had good internal consistency (Cronbach's α 0.86-0.88 for CD and 0.94-0.96 for UC); the total score displayed acceptable test-retest reliability (intraclass correlation coefficients > 0.60 for CD and > 0.90 for UC). FACIT-Fatigue scores had acceptable convergent validity with similar measures. A 7-10 point improvement for CD and 4-9 point improvement for UC on the FACIT-Fatigue total score may represent meaningful improvements. CONCLUSIONS: These results highlight the importance of fatigue among adolescents and adults with CD or UC and provide evidence that the FACIT-Fatigue is content valid and produces reliable, valid, and interpretable scores in these populations. Care should be taken if using the questionnaire with adolescents who may be less familiar with the word "fatigue." Clinical trial registration numbers NCT03105128 (date of registration: 4 April 2017) and NCT02819635 (date of registration: 28 June 2016).

Key concepts of migraine postdrome: a qualitative study to develop a post-migraine questionnaire.

OBJECTIVE: To understand migraine postdrome by directly interviewing migraine patients with postdrome symptoms. To document these symptoms, as well as impacts, as a prelude to developing a postdrome migraine questionnaire. BACKGROUND: Migraine attacks are traditionally divided into 4 phases. Of these, the postdrome is the least studied, and no patient-reported outcomes to assess symptoms and impacts of this migraine phase have been published. METHODS: Qualitative concept elicitation focus groups were conducted with 34 patients in 3 geographically diverse US cities to elicit the symptoms and burden of migraine postdrome. Data elicited from focus groups were coded using Atlas.ti software to facilitate identification of concepts and terminologies of migraine postdrome. A draft questionnaire was developed based on the symptoms and impacts of migraine postdrome described by patients. Cognitive debriefing interviews were conducted with 15 patients in Connecticut and Chicago to confirm content validity, relevance, and comprehension. RESULTS: Patients defined the onset of postdrome as when they no longer experienced the migraine pain. Postdrome was often described as "[being] or [feeling] wiped out" and "headache hangover." The symptoms most frequently reported by the patients who participated in the focus groups and included in the draft post-migraine questionnaire were: tiredness, difficulty concentrating, weakness, dizziness, lightheadedness, and decreased energy. Patients also reported decreased activity level as a result of experiencing postdrome symptoms. Postdrome symptoms were reported to impact the ability to work, to affect family interactions and social life, and to cause cognitive impairment. A preliminary questionnaire measuring severity and duration of symptoms and severity of impacts of the post-migraine experience, with an 11-point (0 to 10) response scale, was developed. This preliminary questionnaire was tested for content validity, relevance, and comprehension using cognitive debriefing interviews. All patients reported that the questionnaire was relevant to their condition. Irrelevant and redundant items such as body tension and annoyance were eliminated. CONCLUSIONS: Migraine postdrome is debilitating for those who experience it. Concept elicitation and cognitive debriefing research support the relevance of the items in the post-migraine questionnaire. Future research will provide evidence of the post-migraine questionnaire's psychometric properties and interpretation guidelines.

Development of a new patient-reported outcome measure in sarcopenia.

OBJECTIVE: The objective of this study was to develop a patient-reported outcome (PRO) to assess reduced muscle strength in sarcopenia. DESIGN: Qualitative research study. SETTING: University of Arkansas for Medical Sciences. PARTICIPANTS: Subjects with sarcopenia. MEASUREMENTS: Adults aged 55 years and older with sarcopenia (n = 12) attended open-ended, concept elicitation interviews to characterize the functional effects of reduced muscle strength on their lives. The resulting qualitative data were analyzed using a qualitative analysis software program (Atlas.ti [Atlas.ti GmbH, Berlin, Germany]) and a common set of codes was developed to summarize the data. Subsequently, the initial PRO measure was drafted. Cognitive interviews were then conducted with additional sarcopenia subjects (n = 12) to refine the measure. RESULTS: Qualitative interviews identified key concepts (eg, impacts) in the areas of activities of daily living, emotions, social activities, energy, balance, coordination, sleep, and strength. Based on data from the cognitive debriefing interviews (eg, understandability, relevance, suggestions to reword items), the PRO measure development team came to consensus on which items or parts of the instructions to retain, revise, or delete. The final measure included 14 items. CONCLUSION: The final PRO measure, the Age-Related Muscle Loss Questionnaire, can be used in both clinical practice and clinical trial settings to assess functional impacts of reduced muscle strength in sarcopenia.