Measuring upper limb function in MS: Which existing patient reported outcomes are fit for purpose?

ABSTRACT:

Background

Multiple Sclerosis (MS) clinical trials increasingly focus on progressive and advanced MS, with upper limb function (ULF) as a key outcome. Within clinical trials, Patient Reported Outcomes (PROs) quantify clinical variables and establish meaningfulness of changes. Scientific standards and regulatory criteria (from Food and Drug Administration [FDA]) require PROs be "fit-for-purpose": well-defined and reliable measures of specific concepts in defined contexts.

Objective

To identify, from literature, existing PROs measuring ULF and determine which satisfy scientific and regulatory clinical trials requirements.

Method

We screened PubMed/Web of Science using multiple relevant terms. Abstracts and full texts were screened using suitability criteria. PRO develop

SUBMITTER: Close J 

PROVIDER: S-EPMC7125352 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature