Principles of good practice for translation of electronic clinical outcome assessments.

Background: While many publications have outlined good practice recommendations for translation and electronic implementation of clinical outcome assessments (COAs), they are often treated as independent processes. The scientific literature currently lacks recommended guidelines on the process of concurrent translation, cultural adaptation and electronic implementation of COAs for clinical research. In response to this need, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) sought to identify actionable steps for addressing the scientific and operational intricacies in this concurrent process.

Methods: Using snowball sampling, semi-structured questions were sent to language service providers (LSPs), electronic clinical outcome assessment (eCOA) providers, and developers/copyright holders. The TCA-SIG workgroup, consisting of 13 members, then led the methodological groundwork for the disseminated surveys and established a cohesive set of recommendations.

Results: The collective feedback that led to the recommendations included a total of 30 experts who responded to the surveys. Most of the respondents worked in companies or represented organizations based in the US and Europe.

Recommendations: The recommendations fall into two main categories: namely, operational and scientific. The operational recommendations consist of active involvement from all stakeholders, the communication of clear expectations from the start, and better clarification of timelines of LSPs involved. Examples of scientific recommendations are electronic language feasibility assessment (ELFA), screenshot proofreading, as well as COA-specific developer and copyright holder guidelines for electronic implementation. COA-specific guidelines and instructions for electronic implementation and evaluation were seen to be needed and key recommendations are discussed in detail in this paper.