COA instrument development
Adelphi Values have experience of developing all types of Clinical Outcome Assessments (COAs) including PRO, ObsRO, ClinRO and PerfO measures. In addition we develop ‘fit for purpose’ instruments to assess the broad range of concepts that can be relevant for assessment in clinical trials and general clinical practice, including: symptoms, physical functioning, domains of health-related quality of life and treatment satisfaction.
Any instrument development should start with consideration of both the ‘Concept of Interest’ and the ‘Context of Use’ for any given COA and set of circumstances. We understand the importance of ensuring instrument development/modification is grounded in qualitative research with patients. However, for symptom assessments especially, the clinical perspective is also highly important. With our strong heritage in instrument development, we are highly focused on developing not just items, but also instructions, response scales and recall periods that will be easy for patients to understand and appropriate and relevant for the intended assessment concept. We have an in-depth understanding of not just the standards that are required by the FDA and EMA for any instrument that might be used to support label claims, but also considerations that are important in other Context of Use. Our established methods are founded on FDA/EMA requirements and conform to the highest industry standards.
Our global team of over 80 people has experience of developing COA instruments in a wide variety of therapeutic areas which we have published extensively.
Taylor F, Higgins S, Carson RT, et al. Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD). Am J Gastroenterol. 2018; 113(1):39-48.
Banderas B, Skup M, Shields AL, Mazar I, Ganguli A. Development of the Rheumatoid Arthritis Symptom Questionnaire (RASQ): a patient reported outcome scale for measuring symptoms of rheumatoid arthritis. Curr Med Res Opin. 2017; 33(9):1643-1651.
Bonner N, Panter C, Kimura A, Sinert R, Moellman J, Bernstein J A. Development and validation of the angiotensin-converting enzyme inhibitor (ACEI) induced angioedema investigator rating scale and proposed discharge criteria. BMC Health Serv Res. 2017; 17: 366
Gater A, Nelson L, Fleming S, Lundy J, Bonner N, Hall R, Marshall C, Staunton H, Krishnan J, Stoloff S, Schatz M, Haughney J on behalf of the Patient-Reported Outcome Consortium’s Asthma Working Group. Assessing asthma symptoms in adolescents and adults: Qualitative research supporting development of the asthma daily symptom diary. Value in Health 2016; 9:440-450