LINGUISTIC VALIDATION AND ELECTRONIC MIGRATION OF THE KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE (KCCQ)

Author(s)

Sydor B1, Spertus J2
1TransPerfect, Washington, DC, USA, 2Health Outcomes Sciences, Overland Park, KS, USA

OBJECTIVES:  The Kansas City Cardiomyopathy Questionnaire (KCCQ), developed by Dr. John Spertus in US English, is a reliable and valid 15-item measure of quality of life in heart failure patients. For a multinational trial, linguistically validated and electronically migrated versions of the KCCQ needed to be created in Cebuano (Philippines), English, Malay, Simplified Chinese (Malaysia), Spanish (Peru), and Sotho and Xhosa (South Africa). METHODS:  An ISPOR- and FDA-compliant methodology was utilized to develop linguistically validated KCCQ paper translations and migrate them to an electronic platform. This process included: 1) Concept definition of the English items; 2) Adaptation for specific countries using existing validated translations; 3) Dual forward translations, reconciliation, back translation into English, and resolution for languages where an existing translation could not be leveraged; 4) Developer review of the back translations (JS); 5) Review of the forward translations by the Sponsor; 6) Cognitive interviewing with five patients with cardiovascular disease; 7) Developer review of the cognitive interviewing feedback; 8) Final proofreading of the paper PROs; 9) Electronic migration. RESULTS:  Developer review was essential to creating conceptually equivalent translations of the KCCQ. Several of his suggested updates were approved by the linguists and enabled the items and response choices to be more suitably adapted for the target country, especially with regard to terms used to define distance. For example, “walking 1 block” was updated to “walking 100m” for South Africa to more effectively illustrate the task for that country. Minimal adaptation was required for the migration of the paper PRO to ePRO. CONCLUSIONS:  Collaboration between the language services provider and instrument developer throughout the linguistic validation and electronic migration process facilitated the achievement of conceptual equivalence and cultural relevance between the English and foreign KCCQ versions. Linguistically validated paper and electronic versions of the KCCQ in these languages are now available for use.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PRM186

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Cardiovascular Disorders

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×