Development and content validity of new patient-reported outcome questionnaires to assess the signs and symptoms and impact of atopic dermatitis: the Atopic Dermatitis Symptom Scale (ADerm-SS) and the Atopic Dermatitis Impact Scale (ADerm-IS)

Foley, Catherine; Tundia, Namita; Simpson, Eric L.; Teixeira, Henrique D.; Litcher‐Kelly, Leighann; Bodhani, Amit

doi:10.1080/03007995.2018.1560222

Cited by 14 publications

(11 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…From various pathophysiological perspectives, atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease associated with pruritus and redness, typically on the face and the inside of elbows and knees [ 1 ]. Therefore, AD is closely connected to patients’ quality of life and comorbidities [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Moringa concanensis L. Alleviates DNCB-Induced Atopic Dermatitis-like Symptoms by Inhibiting NLRP3 Inflammasome-Mediated IL-1β in BALB/c Mice

Kim

Mony

et al. 2022

Pharmaceuticals

View full text Add to dashboard Cite

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus, dry skin and redness on the face and inside elbows or knees. Most patients with AD are children and youths, but it can also develop in adults. In the therapeutic aspect, treatment with corticosteroids for AD has several side effects, such as weight loss, atrophy and acne. In the current study, we examined the anti-inflammatory effect of Moringa concanensis leaves on HaCaT keratinocytes and 2,4-dinitrochlorobenzene (DNCB)-induced atopic dermatitis-like symptoms in BALB/c mice. We observed that M. concanensis treatment exhibited significant inhibition in the production of inflammatory mediators and proinflammatory cytokines, such as IL-1β, in LPS-induced HaCaT keratinocytes by downregulating the NLRP3 inflammasome activation. Moreover, M. concanensis inhibited the activation of JNK, AP-1 and p65, which resulted in the deformation of NLRP3 in LPS-stimulated HaCaT cells. In mice with DNCB-induced AD-like skin lesions, the administration of M. concanensis ameliorated the clinical symptoms, such as the dermatitis score, thickness of lesional ear skin and TEWL. Furthermore, M. concanensis could attenuate the activation of the immune system, such as reducing the spleen index, concentration of the IgE levels and expression of the NLRP3 inflammasome in ear tissues. Therefore, our results suggest that M. concanensis exerts anti-atopic dermatitis effects by inhibiting the NLRP3 inflammasome-mediated IL-1β.

show abstract

Section: Introductionmentioning

confidence: 99%

Moringa concanensis L. Alleviates DNCB-Induced Atopic Dermatitis-like Symptoms by Inhibiting NLRP3 Inflammasome-Mediated IL-1β in BALB/c Mice

Kim

Mony

et al. 2022

Pharmaceuticals

View full text Add to dashboard Cite

show abstract

“…They were recommended to be in category A. Among the 23 multidimensional instruments, 9 (39.1%) were category A (34,35,38,39,(41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57), 6 (26.1%) category B (36,48,(58)(59)(60)(61)(62), and 8 (34.8%) were category C (37,39,46,51,54,(63)(64)(65)(66)(67)(68)(69)(70)(71)(72)(73)(74)(75)(76)(77)(78). None of the included multidimensional instruments has been proved to be sufficient in all of the assessed measurement properties.…”

Section: Psychometric Properties Of the Instruments Identifiedmentioning

confidence: 99%

Patient-reported outcome (PRO) instruments for disease severity and quality of life in patients with atopic dermatitis: a systematic review of English and Chinese literature

Li¹,

Zhang²,

Yang³

et al. 2022

Ann Transl Med

View full text Add to dashboard Cite

Background: Many patient-reported outcome (PRO) on disease severity quality of life (QOL) have been developed for atopic dermatitis (AD) patients. However, none of them on the reliability and validity of the instruments was sufficient for their application in clinical studies. The objective of this study is to identify and assess the quality of recently developed PROs for disease severity and QOL in English and Chinese in AD patients.Methods: We conducted a systematic review of PROs for disease severity and QOL for AD from PubMed, Web of Science, PsycINFO and ERIC (English literatures), and CNKI and Wanfang Data (Chinese literatures) from September 2010 to December 2021 with string including "atopic dermatitis" and "scaling".All studies were screened by 2 reviewers. After being removed duplications, the studies developed the instruments for the AD patients, were reported by patients, and assessing the disease severity or QOL were included.Results: Twenty-six instruments were retrieved. Three single-item Numeric Rating Scale (NRS) and 8 multidimensional instruments assessing disease severity and 15 assessing QOL were found to be originally developed in English (n=23) or Chinese (n=3). After full assessment on the reliability and validity, 3 NRS and 9 multidimensional instruments were recommended. The 3 NRS were Peak Pruritus/Itch NRS, Skin Pain NRS and Sleep Disturbance (SD) NRS. The multidimensional instruments for disease severity included the Patient-Oriented Eczema Measure (POEM), the patient oriented-SCORAD (PO-SCORAD), and Atopic Dermatitis Symptom Score (ADSS), and the instruments for QOLs included Infant's Dermatology Quality of Life Index (IDQOL), Children's Dermatology Life Quality Index (CDLQI), Atopic Dermatitis Control Tool (ADCT), PROMIS ® Itch Questionnaire Mood and Sleep (PIQ-MS), PROMIS-Sleep Disturbance (PROMIS-SD), and PROMIS-Sleep-Related Impairment (PROMIS-SRI) for QOL. However, none of the Chinese PROs either originally developed or adapted were fully validated. Discussion: Single-item NRS is a complement to multidimensional PROs in assessing the disease severity of AD. Quality of these instruments vary greatly and only a few instruments that meet the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) standards are recommended. Therefore, standardization of PROs is essential for developing new instruments, and for adapting a PRO in other populations with different culture and languages.

show abstract

“…Prior to questionnaire development, a review of existing AD-specific instruments was conducted to determine whether there were any existing tools that could be implemented in a clinical trial for the assessment of symptoms and impacts of moderate to severe AD in adolescents and adults [ 5 ]. While AD-specific PRO questionnaires were developed and evaluated by other groups [ 6 – 10 ] [including the consensus group to harmonize core outcome measures for atopic eczema/dermatitis (HOME) [ 11 , 12 ]], none of the reviewed questionnaires met the criteria of the research team for the evaluation of daily and weekly symptoms and impacts in a clinical trial setting for the target patient population.…”

Section: Introductionmentioning

confidence: 99%

“…Thus, three novel PRO questionnaires for adolescents and adults with moderate to severe AD were developed on the basis of best measurement practices summarized in the US Food and Drug Administration’s 2009 PRO guidance [ 13 – 15 ]: Worst Pruritus Numerical Rating Scale (WP-NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS). Evidence of content validity [ 5 , 16 ], psychometric performance, and score interpretation guidance (e.g., meaningful within person change) [ 17 ] has been demonstrated in adolescents and adults with moderate to severe AD.…”

Section: Introductionmentioning

confidence: 99%

“…It is important to translate PRO questionnaire scores into easily understandable reference points for clinicians and patients (i.e., interpretability), as performed for other patient- and clinician-reported assessments for AD [ 18 – 20 ]. This research sought to define severity strata not previously reported for the three PRO questionnaires described above that assess the daily/weekly signs, symptoms, and impacts of moderate to severe AD [ 5 , 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS)

Silverberg

Simpson

Calimlim

et al. 2022

Dermatol Ther (Heidelb)

Self Cite

View full text Add to dashboard Cite

Introduction Three patient-reported outcome (PRO) questionnaires—Worst Pruritus Numerical Rating Scale (WP-NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS)—were developed to assess the symptoms and impacts of atopic dermatitis (AD). Severity strata for these PROs are needed to aid in their interpretation. Methods Using data from a global, randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT03568318) of patients with moderate–severe AD (age ≥ 12 years), equipercentile linking analyses were conducted to define severity strata applying the Patient Global Impression of Severity as an anchor. Analyses were conducted separately for adults and adolescents, and then harmonized between the two age groups. Results The sample included 769 adults and 113 adolescents. For the WP-NRS, 0 was associated with absent, 1–2 with minimal, 3 with mild, 4–7 with moderate, and 8–10 with severe. For the ADerm-SS Skin Pain, 0 was associated with absent, 1 with minimal, 2 with mild, 3–6 with moderate, and 7–10 with severe. For ADerm-SS 7-Item Total Symptom Score (TSS-7), 0–1 was associated with absent, 2–11 with minimal, 12–22 with mild, 23–47 with moderate, and 48–70 with severe. For ADerm-IS Sleep, 0 was associated with absent, 1–3 with minimal, 4–6 with mild, 7–20 with moderate, and 21–30 with severe. For ADerm-IS Daily Activities, 0 was associated with absent, 1–2 with minimal, 3–7 with mild, 8–25 with moderate, and 26–40 with severe. For ADerm-IS Emotional State, 0 was associated with absent, 1–2 with minimal, 3–8 with mild, 9–22 with moderate, and 23–30 with severe. Conclusions These severity strata provide score interpretations of the WP-NRS, ADerm-SS, and ADerm-IS, translating these scores to simple and intuitive outcomes, which can inform clinical studies and clinical practice. Trial Registration Number NCT03568318. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-022-00836-5.

show abstract

Development and content validity of new patient-reported outcome questionnaires to assess the signs and symptoms and impact of atopic dermatitis: the Atopic Dermatitis Symptom Scale (ADerm-SS) and the Atopic Dermatitis Impact Scale (ADerm-IS)

Abstract: Bodhani (2019) Development and content validity of new patient-reported outcome questionnaires to assess the signs and symptoms and impact of atopic dermatitis: the Atopic Dermatitis Symptom Scale (ADerm-SS) and the Atopic Dermatitis Impact Scale (ADerm-IS),

Cited by 14 publications

References 22 publications

Moringa concanensis L. Alleviates DNCB-Induced Atopic Dermatitis-like Symptoms by Inhibiting NLRP3 Inflammasome-Mediated IL-1β in BALB/c Mice

Moringa concanensis L. Alleviates DNCB-Induced Atopic Dermatitis-like Symptoms by Inhibiting NLRP3 Inflammasome-Mediated IL-1β in BALB/c Mice

Patient-reported outcome (PRO) instruments for disease severity and quality of life in patients with atopic dermatitis: a systematic review of English and Chinese literature

Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS)

Contact Info

Product

Resources

About