Validation Study to Assess the Adherence of RA Patients Taking MTX

A multi-centre psychometric validation study, led by Roche, to validate a PRO tool (MEQ) to assess medication adherence in rheumatoid arthritis (RA) for patients being treated with Methotrexate (MTX).

Once recruited, patients completed the MEQ and two generic compliance questionnaires to self-reported adherence. Physicians of the patients also completed additional questionnaires related to the patient, along with a subjective assessment of their adherence to MTX using a 5-point Likert scale.

Objective

>300 patients with RA completing the study within an 11-month timeframe
Sample required a stratified mix of adherent (70%) and non-adherent (30%) patients

The solution

To recruit the correct sample, a robust patient database was crucial which was achieved through collaboration with a delivery partner, OPCRD.

Clinpal onboarded practices and secured patient participation through to completion. With a seamless, flexible and personalised direct-to-patient invitation process, with telephone follow up, patients were motivated to enrol and complete their questionnaires.

Results

1,043 patients invited
325 patients enrolled from 38 practices, 320 successfully completed
The enrolment and completion rates of circa 31% exceed industry standards for direct-to-patient studies.
Stratification targets were met without incurring over-recruitment
Age demographics showed no significant differences in participation and compliance for the age range 70-90 years
Curtis et al. concluded that the MEQ is a reliable and valid instrument to assess the adherence of RA patients taking MTX

Additional reading and sources

Curtis, J.R., Nebesky, J.M., de Bock, E. et al. Development and validation of the Methotrexate Experience Questionnaire, a new methotrexate oral treatment adherence tool in rheumatoid arthritis. J Patient Rep Outcomes 5, 69 (2021). https://doi.org/10.1186/s41687-021-00339-5.
https://f.hubspotusercontent30.net/hubfs/20088388/METNA%20Case%20Study.pdf