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Establishing Equivalence of Electronic Clinician-Reported Outcome Measures.
Fuller, Rebecca L M; McNamara, Cynthia W; Lenderking, William R; Edgar, Chris; Rylands, Angela; Feaster, Todd; Sabatino, Donald; Miller, David S.
Afiliação
  • Fuller RLM; 1 Bracket, Wayne, PA, USA.
  • McNamara CW; 1 Bracket, Wayne, PA, USA.
  • Lenderking WR; 2 Evidera, Lexington, MA, USA.
  • Edgar C; 3 Roche, Welwyn Garden City, United Kingdom.
  • Rylands A; 3 Roche, Welwyn Garden City, United Kingdom.
  • Feaster T; 1 Bracket, Wayne, PA, USA.
  • Sabatino D; 1 Bracket, Wayne, PA, USA.
  • Miller DS; 1 Bracket, Wayne, PA, USA.
Ther Innov Regul Sci ; 50(1): 30-36, 2016 Jan.
Article em En | MEDLINE | ID: mdl-30236021
BACKGROUND: Electronic administration of clinician-reported outcomes (eClinROs) has advantages over paper-based methods, but the mode of administration change has the potential to affect the validity of the scale. The literature on migration of patient-reported outcomes (PROs) suggests that there are different levels of modification, which necessitate different approaches to demonstrating mode equivalence. However, little has been written on the migration of ClinROs to electronic administration. METHODS: We propose a method of comparing paper and electronic versions of scales that includes a comparison based on content and a comparison based on format. The determination of whether the eClinRO has undergone minor, moderate, or substantial modification will drive the necessary studies required for validation. RESULTS: The unique characteristics of ClinROs suggest 2 additional types of modifications, including functionality adaptation and adaptation of instructions. CONCLUSIONS: In many respects, the migration of a ClinRO to electronic administration is similar to that of a PRO. This article has explored the ways in which there might be special considerations for ClinROs that have not been elaborated for PROs.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2016 Tipo de documento: Article