Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Klimawandel und Gesundheit Neues aus dem Markt COVID-19 Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Konkret geht es um den Diabetes-Patienten mit kardiovaskulären Erkrankungen oder Risiken, die Herzinsuffizienz sowie die kardiovaskuläre Primär- und Sekundärprävention. Sind Sie hier schon auf dem neuesten Stand? Unsere Experten beleuchten, wo und warum das bisherige Procedere geändert werden soll und was in der Praxis sinnvoll ist. Holen Sie sich Ihr Update und 2 CME-Punkte beim MMW-Webinar am 24. April von 17.30 bis 19 Uhr. 
Erweiterte Suche
Anmelden
nach oben
Current Dermatology Reports
Erschienen in: Current Dermatology Reports 3/2017

01.06.2017 | Epidemiology (R Dellavalle, Section Editor)

Why Outcome Measures in Dermatology Are Becoming Patient Centric

verfasst von: Jennifer Nergard-Martin, Fariha Siddiqui, Ajay Kailas, Monet Winslow, James A Solomon

Erschienen in: Current Dermatology Reports | Ausgabe 3/2017

Einloggen, um Zugang zu erhalten

Abstract

Purpose of Review

Many “validated” treatment outcome assessments in clinical trials fail to include outcomes important to patients. This review will focus on recent efforts to revise and make patient-centric clinical trial outcomes used in psoriasis, acne vulgaris, atopic dermatitis, and hidradenitis suppurativa.

Recent Findings

Over recent years, international coalitions have been formed to revise the investigator-oriented “validated” measures (e.g., PASI, IGA) in order to incorporate outcomes important to patients These not only include quality of life (QoL) assessments but also the anatomic location, physical discomfort, and appearance. This review discusses work underway to include patients in formatting revised outcome assessments.

Summary

Historically, outcome measures have been developed by clinicians and pharmaceutical companies for use in clinical trials. Nonetheless, a movement is underway supported by regulatory agencies, government officials, and patient advocacy groups to include patients in the process of redesigning clinical trial outcome measures.
Literatur
1.
Marcus AD. Design power: patients play researchers in drug trials. 2014.
2.
de Wit MP, Berlo SE, Aanerud GJ, Aletaha D, Bijlsma JW, Croucher L, et al. European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects. Ann Rheum Dis. 2011;70(5):722–6.CrossRefPubMed
3.
CSG Annual Meeting 2015. Cochrane Skin. 2015.
4.
Norlin JM, Steen Carlsson K, Persson U, Schmitt-Egenolf M. Analysis of three outcome measures in moderate to severe psoriasis: a registry-based study of 2450 patients. Br J Dermatol. 2012;166(4):797–802.CrossRefPubMed
5.
Naldi L, Svensson A, Zenoni D, Diepgen T, Elsner P, Grob JJ, et al. Comparators, study duration, outcome measures and sponsorship in therapeutic trials of psoriasis: update of the EDEN psoriasis survey 2001-2006. Br J Dermatol. 2010;162(2):384–9.CrossRefPubMed
6.
Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003;49(2 Suppl):S57–61.CrossRefPubMed
7.
Schmitt J, Ford DE. Understanding the relationship between objective disease severity, psoriatic symptoms, illness-related stress, health-related quality of life and depressive symptoms in patients with psoriasis—a structural equations modeling approach. Gen Hosp Psychiatry. 2007;29(2):134–40.CrossRefPubMed
8.
• Armstrong AW, Villanueva Quintero DG, Echeverria CM, Gu Y, Karunaratne M, Reyes SO. Body region involvement and quality of life in psoriasis: analysis of a randomized controlled trial of adalimumab. Am J Clin Dermatol. 2016;17(6):691–9. This study discusses how body region impact on quality of life and association with PASI score, thus the importance of including body region in patient-centric outcome measures. CrossRefPubMedPubMedCentral
9.
• Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nyirady J, Papavassilis C, et al. Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis. Int J Dermatol. 2016;55(3):e147–55. This study reviews the reliability and validity of a new tool, Psoriasis Symptom Diary, generating patient-reported endpoints. CrossRefPubMed
10.
• Blome C, Gosau R, Radtke MA, Reich K, Rustenbach SJ, Spehr C, et al. Patient-relevant treatment goals in psoriasis. Arch Dermatol Res. 2016;308(2):69–78. This study emphasizing the importance to include changes from baseline as part of routine patient-centric outcome assessments. Current assessments are static, thus based on the status at the moment of assessment without consideration of changes from baseline. CrossRefPubMed
11.
Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001;137(3):280–4.PubMed
12.
Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician’s Global Assessment. J Am Acad Dermatol. 2004;51(4):563–9.CrossRefPubMed
13.
Spuls PI, Lecluse LL, Poulsen ML, Bos JD, Stern RS, Nijsten T. How good are clinical severity and outcome measures for psoriasis?: quantitative evaluation in a systematic review. J Investig Dermatol. 2010;130(4):933–43.CrossRefPubMed
14.
Puzenat E, Bronsard V, Prey S, Gourraud PA, Aractingi S, Bagot M, et al. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol : JEADV. 2010;24(Suppl 2):10–6.CrossRefPubMed
15.
Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol. 1999;141(2):185–91.CrossRefPubMed
16.
Varada S, Kim N, Abernethy A, Armstrong A, Callis-Duffin K, Garg A, et al. IDEOM: International Dermatoloy Outcome Measures—proceedings from the first meeting. Psoriasis Forum. 2014;20(2):66–72.
17.
• Solomon JA, Schuering BS. An update on the IDEOM (International Dermatology Outcome Measures) initiative to restructure current psoriasis outcome assessment measures to a globally uniform set of patient-centric outcome measures for use in clinical trials and clinical practice. Psoriasis Forum. 2015;21(1):50–2. This paper is an update on IDEOM and its goals for establishing an internation consensus of patient-centric outcome assessments. This paper also reviewed pSOAR, a similar effort initiated by ADEN and DermEpi ERG. This group later joined with IDEOM.
18.
• Elman SA, Merola JF, Armstrong AW, Duffin KC, Latella J, Garg A, et al. The International Dermatology Outcome Measures (IDEOM) initiative: a review and update. J Drugs Dermatol : JDD. 2017;16(2):119–24. This paper is the latest update on the IDEOM initiative which is determined to develop internationally acceptable patient-centric outcomes measures through a collaborative effort of patients, patient advocacy groups, health economists, physicians, industry partners, payers, and regulatory agencies. PubMed
19.
Gottlieb A, Swerlick R. IDEOM: International Dermatology Outcomes Measures; A Call to Action. Psoriasis Forum. 2013;19(3):107–9.
20.
Gottlieb AB, Armstrong AW, Christensen R, Garg A, Duffin KC, Boehncke WH, et al. The International Dermatology Outcome Measures initiative as applied to psoriatic disease outcomes: a report from the GRAPPA 2013 meeting. J Rheumatol. 2014;41(6):1227–9.CrossRefPubMed
21.
Gottlieb AB, Levin AA, Armstrong AW, Abernethy A, Duffin KC, Bhushan R, et al. The International Dermatology Outcome Measures Group: formation of patient-centered outcome measures in dermatology. J Am Acad Dermatol. 2015;72(2):345–8.CrossRefPubMed
22.
Lynn DD, Umari T, Dunnick CA, Dellavalle RP. The epidemiology of acne vulgaris in late adolescence. Adolescent health, medicine and therapeutics. 2016;7:13–25.CrossRefPubMedPubMedCentral
23.
• Barratt H, Hamilton F, Car J, Lyons C, Layton A, Majeed A. Outcome measures in acne vulgaris: systematic review. Br J Dermatol. 2009;160(1):132–6. This journal article, albeit more than 3 years prior to this review, is an excellent review of the importance to include the psychological impact of acne as an essential feature of patient-centric outcomes. CrossRefPubMed
24.
• Agnew T, Furber G, Leach M, Segal L. A comprehensive critique and review of published measures of acne severity. The Journal of clinical and aesthetic dermatology. 2016;9(7):40–52. This paper is a comprehensive review of the published measures of acne severity that also suggests what an ideal acne outcome measure scale would include. PubMedPubMedCentral
25.
• Yap FB. Cardiff acne disability index in Sarawak, Malaysia. Ann Dermatol. 2012;24(2):158–61. This paper is of historical importance, introducing a patient-centric outcome measure for global use. CrossRefPubMedPubMedCentral
26.
Bonafede M, Joseph GJ, Princic N, Harrison DJ. Annual acquisition and administration cost of biologic response modifiers per patient with rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis. Med Econ. 2013;16(9):1120–8.
27.
• Alexis A, Daniels SR, Johnson N, Pompilus F, Burgess SM, Harper JC. Development of a new patient-reported outcome measure for facial acne: the Acne Symptom and Impact Scale (ASIS). J Drugs Dermatol : JDD. 2014;13(3):333–40. An article describes the development of a new, promising acne outcome measure, the Acne Symptoms and Impact Scale (ASIS). PubMed
28.
• Hudgens S, Harper JC, Daniels SR, Banderas B, Varon S, Alexis AF. Validation of a new patient-reported outcome measure for facial acne: the Acne Symptom and Impact Scale (ASIS). J Drugs Dermatol : JDD. 2015;14(6):552–9. An article describing that the content of the ASIS is both reliable and valid for Caucasian populations, with similar findings noted for non-Caucasian subgroups. PubMed
29.
Furue M, Chiba T, Tsuji G, Ulzii D, Kido-Nakahara M, Nakahara T, et al. Atopic dermatitis: immune deviation, barrier dysfunction, IgE autoreactivity and new therapies. Allergology international : official journal of the Japanese Society of Allergology. 2017.
30.
Kim J, Kim H, Lim D, Lee YK, Kim JH. Effects of indoor air pollutants on atopic dermatitis. Int J Environ Res Public Health. 2016;13(12):1220. doi:10.​3390/​ijerph13121220.
31.
Han RT, Back SK, Lee H, Lee J, Kim HY, Kim HJ, et al. Formaldehyde-induced aggravation of pruritus and dermatitis is associated with the elevated expression of Th1 cytokines in a rat model of atopic dermatitis. PLoS One. 2016;11(12):e0168466.CrossRefPubMedPubMedCentral
32.
Schwensen JF, Friis UF, Menne T, Flyvholm MA, Johansen JD. Contact allergy to preservatives in patients with occupational contact dermatitis and exposure analysis of preservatives in registered chemical products for occupational use. International archives of occupational and environmental health. 2017.
33.
Celakovska J, Bukac J. The severity of atopic dermatitis evaluated with the SCORAD index and the occurrence of bronchial asthma and rhinitis, and the duration of atopic dermatitis. Allergy & rhinology (Providence, RI). 2016;7(1):8–13.CrossRef
34.
Chalmers JR, Simpson E, Apfelbacher CJ, Thomas KS, von Kobyletzki L, Schmitt J, et al. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative). Br J Dermatol. 2016;175(1):69–79.CrossRefPubMed
35.
36.
37.
Thorlacius L, Ingram JR, Garg A, Villumsen B, Esmann S, Kirby JS, et al. Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes. BMJ Open. 2017;7(2):e014733.CrossRefPubMedPubMedCentral
38.
• Ingram JR, Hadjieconomou S, Piguet V. Development of core outcome sets in hidradenitis suppurativa: systematic review of outcome measure instruments to inform the process. Br J Dermatol. 2016;175(2):263–72. This paper is a recent systematic review of 30 outcome measures used for hidradenitis suppurativa used in clinical trials that followed PRISM guidelines. CrossRefPubMed
39.
Kimball AB, Jemec GB, Yang M, Kageleiry A, Signorovitch JE, Okun MM, et al. Assessing the validity, responsiveness and meaningfulness of the hidradenitis suppurativa clinical response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014;171(6):1434–42.CrossRefPubMed
40.
Chiricozzi A, Faleri S, Franceschini C, Caro RD, Chimenti S, Bianchi L. AISI: a new disease severity assessment tool for hidradenitis suppurativa. Wounds : a compendium of clinical research and practice. 2015;27(10):258–64.
Metadaten
Titel
Why Outcome Measures in Dermatology Are Becoming Patient Centric
verfasst von
Jennifer Nergard-Martin
Fariha Siddiqui
Ajay Kailas
Monet Winslow
James A Solomon
Publikationsdatum
01.06.2017
Verlag
Springer US
Erschienen in
Current Dermatology Reports / Ausgabe 3/2017
Elektronische ISSN: 2162-4933
DOI
https://doi.org/10.1007/s13671-017-0187-4

Weitere Artikel der Ausgabe 3/2017

Current Dermatology Reports 3/2017 Zur Ausgabe

Epidemiology (R Dellavalle, Section Editor)

Phytochemicals and Naturally Occurring Substances in the Chemoprevention of Skin Cancer

Epidemiology (R Dellavalle, Section Editor)

Epidemiology of Keratinocyte Carcinoma

Epidemiology (R Dellavalle, Section Editor)

Environmental Risk Factors for Development of Atopic Dermatitis: a Systematic Review

Skin Cancer (D Siegel and O Markowitz, Section Editors)

Reflectance Confocal Microscopy for Margin Assessment and Management of Lentigo Maligna

Atopic Dermatitis (T.Bieber, Section Editor)

Atopic Dermatitis in Infants and Toddlers: a Diagnostic Challenge in Daily Practice

Epidemiology (R Dellavalle, Section Editor)

Skin Cancer Prevention Among Hispanics: a Review of the Literature

Leitlinien kompakt für die Dermatologie

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Kostenlos registrieren

Neu im Fachgebiet Dermatologie

16.04.2024 | Infektiologie | Nachrichten

Kein Abstrich bei chronischen Wunden ohne Entzündungszeichen!

12.04.2024 | Vitiligo | Nachrichten

Vitiligo: Prävalenz steigt und viele Erkrankte werden spät behandelt

12.04.2024 | Atopische Dermatitis | Nachrichten

Dupilumab ist mit kutanen T-Zell-Lymphomen assoziiert

09.04.2024 | DGP 2024 | Kongressbericht | Nachrichten

Chemotherapie mit Hindernissen
weitere anzeigen

Update Dermatologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen
Bildnachweise