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)

References

• Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(Suppl 1):8–16
   PubMed Web of Science ®Google Scholar
• National Eczema Association. Atopic dermatitis. NEA; 2016 [cited 2016 July 7]. San Rafael, California, USA. Available from: https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis-2/.
   Google Scholar
• National Institute of Arthritis and Musculoskeletal and Skin Diseases. Who has atopic dermatits? NIAMSD; 2013 [cited 2016 July 7]. Bethesda, Maryland, USA. Available from: http://www.niams.nih.gov/health_info/atopic_dermatitis/#b.
   Google Scholar
• Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23:S115–S123.
   PubMed Web of Science ®Google Scholar
• Drucker AM, Wang AR, Li WQ, et al. The burden of atopic dermatitis: summary of a report for the National Eczema Association. J Invest Dermatol. 2017;137:26–30.
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. Silver Spring, Maryland, USA. US DoHHS; 2009.
   Google Scholar
• Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument. Value Health. 2011;14:967–977.
   PubMed Web of Science ®Google Scholar
• Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2-assessing respondent understanding. Value Health. 2011;14:978–988.
   PubMed Web of Science ®Google Scholar
• Ando T, Hashiro M, Noda K, et al. Development and validation of the psychosomatic scale for atopic dermatitis in adults. J Dermatol. 2006;33:439–450.
   PubMed Web of Science ®Google Scholar
• Chalmers JR, Simpson E, Apfelbacher CJ, 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;175:69–79.
   PubMed Web of Science ®Google Scholar
• Whalley D, McKenna SP, Dewar AL, et al. A new instrument for assessing quality of life in atopic dermatitis: international development of the Quality of Life Index for Atopic Dermatitis (QoLIAD). Br J Dermatol. 2004;150:274–283.
   PubMed Web of Science ®Google Scholar
• Taieb A, Boralevi F, Seneschal J, et al. Atopic dermatitis burden scale for adults: development and validation of a new assessment tool. Acta Derm Venereol. 2015;95:700–705.
   PubMed Web of Science ®Google Scholar
• Marquis P, Lasch KE, Delgado-Herrera L, et al. Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome. ClinTranslGastroenterol. 2014;5:e59.
   Web of Science ®Google Scholar
• Trask PC, Trivedi B, Palsgrove A, et al. Symptoms of multiple myeloma: results of hybrid concept elicitation/cognitive debriefing interviews. Blood. 2014;124:5973.
   Web of Science ®Google Scholar
• Weitzman EA, Miles MB. Computer programs for qualitative data analysis. London: Sage Publications; 1995.
   Google Scholar
• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15:1277–1288.
   PubMed Web of Science ®Google Scholar
• Lamoureux R, Galipeau N, Yaworsky A, et al. How many subjects are enough for symptom-focused concept elicitation studies? A retrospective analysis of saturation across twenty-six studies. Abstract presented at: the 20th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 16–20 May, 2015.; Philadelphia, Pennsylvania, USA. 2015.
   Google Scholar
• Turner-Bowker DM, Lamoureux RE, Stokes J, et al. Informing a priori sample size estimation in qualitative concept elicitation interview studies for clinical outcome assessment instrument development. Value Health. 2018;21:839–842.
   PubMed Web of Science ®Google Scholar
• Willis GB. Cognitive interviewing: a tool for improving questionnaire design. Thousand Oaks, CA: Sage Publications; 2005.
   Google Scholar
• Ericsson KA, Simon HA. Protocol analysis: Verbal reports as data. Cambridge, MA: MIT Press; 1993.
   Google Scholar
• Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273:59–65.
   PubMed Web of Science ®Google Scholar
• Stull DE, Leidy NK, Parasuraman B, et al. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin. 2009;25:929–942.
   PubMed Web of Science ®Google Scholar
• Gorin AA, Stone AA. Recall biases and cognitive errors in retrospective self-reports: a call for momentary assessments. In: Baum A, Revenson T, Singer J, editors. Handbook of health psychology. Mahwah, NJ: Erlbaum; 2001. p. 405–414.
   Google Scholar
• Stone AA, Broderick JE, Shiffman SS, et al. Understanding recall of weekly pain from a momentary assessment perspective: absolute agreement, between- and within-person consistency, and judged change in weekly pain. Pain. 2004;107:61–69.
   PubMed Web of Science ®Google Scholar
• Broderick JE, Schwartz JE, Vikingstad G, et al. The accuracy of pain and fatigue items across different reporting periods. Pain. 2008;139:146–157.
   PubMed Web of Science ®Google Scholar
• Benjamin K. Workshop 13: Application of the Report’s Final Recommendations: Clinical Outcomes Assessment (COA) Measurement in Rare Disease Clinical Trials Emerging Good Practices Task Force. ISPOR 22nd Annual International Meeting; 20–24 May 2017. Boston, Massachusetts, USA.
   Google Scholar
• Napolitano M, Megna M, Patruno C, et al. Giornale italiano di dermatologia e venereologia: organo ufficiale. [Adult atopic dermatitis: a review.] Societa italiana di dermatologia e sifilografia. 2016;151:403–411
   Google Scholar