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Severity strata for five patient-reported outcomes in adults with atopic dermatitis.

ABSTRACT: BACKGROUND:Several patient-reported outcomes have been used to assess the burden of atopic dermatitis (AD). Some are disease specific, such as the Patient-Oriented Eczema Measure (POEM), while others pertain to itch, for example the numerical rating scale (NRS)-itch, ItchyQoL and 5-D itch, or dermatological disease in general, for example the Dermatology Life Quality Index (DLQI). Development of severity strata is essential for proper interpretability of these assessments. OBJECTIVES:To confirm previously developed strata for POEM, DLQI and raw ItchyQoL, and develop strata for the NRS-itch, mean ItchyQoL and 5-D itch scale for use in adults with AD. METHODS:Self-administered questionnaires were completed by 210 adults with AD in a dermatology practice setting. Strata were selected using an anchoring approach based on patient-reported disease severity. RESULTS:We confirmed the existing strata for POEM (mild 0-7, moderate 8-16, severe 17-28; ? = 0·440), DLQI (mild 0-5, moderate 6-10, severe 11-30; ? = 0·398) and NRS-itch (mild 0-3, moderate 4-6, severe 7-10; ? = 0·499). However, the preferred band for raw ItchyQoL was mild 22-58, moderate 59-74 and severe 75-110 (? = 0·379) and for mean ItchyQoL, mild 1-2·9, moderate 3·0-3·9, severe 4·0-5·0 (? = 0·374). The preferred band for 5-D itch scale was mild 0-11, moderate 12-17 and severe 18-25 (? = 0·331). CONCLUSIONS:Existing strata for POEM and DLQI performed well in adult AD. Previously reported strata for visual analogue scale-itch performed best for NRS-itch. We identified banding for the raw ItchyQoL for our AD population that varies slightly from the banding published for a more heterogeneous population. Finally, we proposed strata for mean ItchyQoL and 5-D itch scale in adult AD.

SUBMITTER: Vakharia PP

PROVIDER: S-EPMC5906166 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Severity strata for five patient-reported outcomes in adults with atopic dermatitis.

Vakharia P P PP Chopra R R Sacotte R R Patel N N Immaneni S S White T T Kantor R R Hsu D Y DY Simpson E L EL Silverberg J I JI

The British journal of dermatology 20180306 4

<h4>Background</h4>Several patient-reported outcomes have been used to assess the burden of atopic dermatitis (AD). Some are disease specific, such as the Patient-Oriented Eczema Measure (POEM), while others pertain to itch, for example the numerical rating scale (NRS)-itch, ItchyQoL and 5-D itch, or dermatological disease in general, for example the Dermatology Life Quality Index (DLQI). Development of severity strata is essential for proper interpretability of these assessments.<h4>Objectives< ...[more]

PMID: 29048751

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Project description:BackgroundThere is limited understanding of severity rating of atopic dermatitis in clinical practice.ObjectivesTo evaluate the agreement between physician- and patient-rated severity of atopic dermatitis.MethodsData were collected from the 2014 Adelphi US Atopic Dermatitis Disease Specific Programme, a cross-sectional survey of physicians and their patients with a history of moderate-to-severe atopic dermatitis; patients voluntarily completed a questionnaire. Current disease severity (mild/moderate/severe), based on personal judgment, was rated independently by patients and their physicians. The weighted kappa statistic identified level of agreement between physicians and patients. Bivariate analyses characterized agreement; multi-nomial logistic regression identified factors associated with discordance.ResultsOverall, 678 patients were included (369 [54.4%] were women, 525 [77.4%] were White, mean age was 39.3 years). Agreement was moderate (weighted kappa = 0.52): compared with physician ratings, patient-rated severity was higher in 76 patients (11.2%), lower in 137 patients (20.2%), and matched in 465 patients (68.6%). There were no differences in the rates of agreement between physician and patient ratings based on physician specialty (p = 0.6781), objective severity measures [Eczema Area and Severity Index score (p = 0.5308), percent body surface area affected (p = 0.9872), and current systemic immunosuppressant use (p = 0.9197)]. Multivariate analysis showed patients with a worse quality of life (Dermatology Life Quality Index) were more likely to rate a higher severity (relative risk ratio 1.04, 95% confidence interval 1.00-1.08; p = 0.0460). Physicians were more likely to rate a higher severity with a greater physician-reported sleep disturbance (relative risk ratio 1.71, 95% confidence interval 1.01-2.89; p = 0.0440).ConclusionsAlmost one-third of patients rated atopic dermatitis severity differently from their physicians, supporting the importance of the patient perspective in the severity assessment of atopic dermatitis and the need for greater communication between patients and physicians.

Project description:Patient-reported outcome measures (PROMs) provide an important complement to physician-assessed clinical outcome measures in dermatologic diseases such as atopic dermatitis (AD) and chronic hand eczema (CHE). AD and CHE are chronic and relapsing inflammatory skin conditions that often co-occur. While both diseases result in various signs and symptoms that are burdensome and can negatively affect patients' lives, there may be distinct differences in the signs, symptoms, burden, and health-related quality of life (HRQOL) impact of these diseases. The objective of this study was to identify and evaluate PROMs used in studies of AD and CHE. The aim was to explore the assessment of key symptoms and impacts, and identify any gaps in the measures in use. A structured review of the PubMed database was conducted to identify PROMs used or developed for use in AD or CHE. The Dermatology Life Quality Index (DLQI), the Pruritus/Itch Numeric Rating Scale (NRS), the Patient-Oriented Eczema Measure (POEM), and the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) were identified and reviewed in detail. With these measures, the AD and CHE symptoms and impacts most commonly evaluated in the literature include dermatology-related HRQOL in the domains of symptoms and feelings, daily activities, leisure, work and school, personal relationships, and adverse effects; pruritus; sleep disturbance; AD-specific symptoms (dryness, itching, flaking, cracking, bleeding, and weeping/oozing); and CHE-specific symptoms (pain, itch, fissuring, redness, bleeding, and dryness). A review of regulatory labels of drugs approved for AD by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) found that, among the four measures reviewed, the Pruritus NRS was included in the FDA and EMA labels for dupilumab, the DLQI was included in the EMA labels for dupilumab and tacrolimus, and the POEM was included in the EMA label for dupilumab. Key symptoms of AD (e.g. itching, flaking, cracking) and CHE (e.g. pain, itching, fissuring) are increasingly being assessed with PROMs; however, primary endpoints in clinical trials are often based on clinician-reported outcome measures. As therapeutic strategies in dermatology are targeted at specific dermatologic symptoms and diseases affecting specific sites (e.g. CHE), future research should explore patients' experiences with these symptoms and sites and the changes with treatment that are most meaningful to them.

Project description:BackgroundPatient-focused approaches to capturing day-to-day variability in sleep disturbance are needed to properly evaluate the sleep benefits of new treatments. Such approaches rely on patient-reported outcome (PRO) measures validated in the target patient population.MethodsUsing atopic dermatitis (AD) as an example of a disease in which sleep is commonly disturbed, we developed a strategy for measuring sleep disturbance in AD trials. In developing this strategy, we conducted a targeted literature review and held concept elicitation interviews with adolescents and adults with AD. We subsequently identified potentially suitable PRO measures and cognitively debriefed them. Finally, we evaluated their psychometric properties using data from phase 2b (NCT03100344) and phase 3 (NCT03985943 and NCT03989349) clinical trials.ResultsThe literature review confirmed that sleep disturbance is a key impact of AD but failed to identify validated PRO measures for assessing fluctuations in sleep disturbance. Subsequent concept elicitation interviews confirmed the multidimensional nature of sleep disturbance in AD and supported use of a single-item measure to assess overall sleep disturbance severity, complemented by a diary to capture individual components of sleep disturbance. The single-item sleep disturbance numerical rating scale (SD NRS) and multi-item Subject Sleep Diary (SSD)-an AD-adapted version of the Consensus Sleep Diary-were identified as potentially suitable PRO measures. Cognitive debriefing of the SD NRS and SSD demonstrated their content validity and their understandability to patients. Psychometric analyses based on AD trial data showed that the SD NRS is a well-defined, reliable, and fit-for-purpose measure of sleep disturbance in adults with AD. Furthermore, the SD NRS correlated with many SSD sleep parameters, suggesting that most concepts from the SSD can be covered using the SD NRS.ConclusionsUsing these findings, we developed an approach for measuring sleep disturbance in AD trials. Subject to further research, the same approach could also be applied to future trials of other skin diseases where itch causes sleep disturbance.

Project description:BackgroundAtopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life.ObjectiveThis analysis evaluated changes in patient-reported outcomes of disease-specific signs/symptoms and health-related quality of life in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with once-daily oral abrocitinib 200-mg or 100-mg monotherapy.MethodsPooled data from one phase IIb (NCT02780167) and two phase III (NCT03349060, JADE MONO-1; NCT03575871, JADE MONO-2) monotherapy trials in adult and adolescent patients with moderate-to-severe atopic dermatitis were analyzed. Patient-reported outcome assessments included: global severity, itch, and multi-item measures that assess other signs and symptoms of atopic dermatitis. Additional patient-reported outcome assessments measured depression, anxiety, fatigue, disease-specific and general health-related quality of life, and work and general productivity among employed patients.ResultsOverall, 942 patients were included in this analysis. Improvements were observed from the first post-baseline assessment to week 12 across all patient-reported outcomes, including Patient Global Assessment (PtGA) score of 0/1 (35.5%, 19.8%, and 5.9% for 200 mg, 100 mg, and placebo, respectively), ≥ 4-point improvement in Night Time Itch Scale (NTIS; 57.0%, 42.7%, and 12.7%), change from baseline in Patient-Oriented Eczema Measure (POEM) score (- 11.4, - 8.2, and - 3.4), 1-point improvement in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD; 75.2%, 65.1%, and 33.5%), Hospital Anxiety and Depression Scales (HADS) anxiety (- 2.0, - 1.7, and - 1.0) and depression (- 1.7, - 1.3, and - 0.1).ConclusionsAbrocitinib monotherapy improved disease-specific signs/symptoms and health-related quality of life across multiple domains as reported by adult and adolescent patients with moderate-to-severe atopic dermatitis, complementing clinician-reported efficacy and safety outcomes.Clinical trial registrationNCT02780167 (registered 23 May, 2016), NCT03349060 (registered 21 November, 2017), NCT03575871 (registered 3 July, 2018).

Dataset Information

Severity strata for five patient-reported outcomes in adults with atopic dermatitis.

Publications

Severity strata for five patient-reported outcomes in adults with atopic dermatitis.

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