OBJECTIVES:

According to current rheumatoid arthritis (RA) guidelines, treatment selection should be based on a shared patient-physician decision. Patient Decision Aids (PDAs) facilitate shared-decision making by improving patient-physician communication and allowing patients to express their preferences. We aim to develop and to assess the effectiveness of a PDA to support treatment decision-making in Spanish patients with moderate-to-severe RA.

METHODS:

The PDA was developed in accordance with the systematic process proposed by the International Patient Decision Aids Standards. A steering group led the project. PDA prototype was developed based on literature reviews and focus groups. To check PDA comprehensibility, acceptability and feasibility, alpha-testing (preliminary test carried out by potential users) was performed through two discussion groups (patients and healthcare professionals) and using the Decision Support Acceptability Scale. To assess PDA effectiveness, beta-testing means before and after PDA use were compared within patients using a paired t-test.

RESULTS:

The PDA developed included: 1) RA brief description; 2) treatment information, and 3) values clarification. Alpha-testing revealed that patients considered that information provided by PDA was good or excellent; and rheumatologists agreed that PDA was easy to understand, to use, and allowed to reach a shared-decision. Results of beta-testing showed that PDA use significantly reduced means for overall scores of decisional conflict scale (33.17 vs. 24.65; p=0.0003) and for all subscales: feeling uncertain (41.13 vs. 30.25; p=0.0001), unclear about values (35.65 vs. 25.00; p=0.0054), uninformed (39.04 vs. 29.32; p=0.0036), ineffective decision (27.66 vs. 18.06; p=0.0001) and unsupported (24.07 vs. 22.84; p=0.0245).

CONCLUSIONS:

A PDA for Spanish patients with moderate-to-severe RA that reduces patients’ decisional conflict and increases their preparation for decision-making has been developed. The use of this PDA in routine clinical practice may promote share-decision and improve the quality of decision-making process and the choice that is made.