PROTECT-DIVERSITY

Utility of multi-lingual consent to promote inclusivity in clinical trials

Patients who experience language barriers are often excluded from taking part in research.

Aim

To test whether multi-lingual consent materials can improve the diversity of the platform sample compared to traditional consent materials.

Inclusion criteria:

  1. Patients aged 18 years and over undergoing elective surgery

Exclusion criteria:

  1. Inability or refusal to provide informed consent
  2. Co-enrolment in PROTECT CTIMP comparisons
  3. Previous enrolment to the PROTECT-DIVERSITY comparison

Objectives:

  1. Compare the impact of using multi-lingual consent forms compared to consent forms in English
    on the ethnic diversity of patients included in the study.
  2. Compare the accuracy and completeness of protected characteristics data collection (age, sex, ethnicity, partner status, disability, pregnancy status, religion, sexual orientation and gender reassignment) using different methods (HES, electronic questionnaires, direct questioning).

Outcome measures

  1. Primary outcome: Reciprocal diversity index for ethnicity on a scale of 0 to 100
  2. Secondary outcome:
    • Completeness of data collection for protected characteristics.
    • Degree of agreement for protected characteristics data between data collection modalities.

Expected outputs

A publication describing the utility of multi-lingual consent methods to improve the diversity of patient inclusion in perioperative research. This will inform the consent strategy for PROTECT.

PROTECT-DIVERSITY Appendix v2.0 20.01.2025

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