WHY DO PATIENTS CHOOSE NOT TO PARTICIPATE IN RANDOMIZED CONTROLLED TRIALS COMPARING OPERATIVE WITH NONOPERATIVE TREATMENT?

Shared decision-making with patients regarding operative or non-operative treatment requires careful consideration of patient factors, preferences, and potential treatment outcomes. Recent data supports that open reduction and internal fixation (ORIF) of isolated ulnar diaphyseal fractures results in earlier functional recovery with minimal complications; however, shared-decision-making should include patient preferences, perspectives, expectations, and experiences. This study aimed to understand why patients prefer operative or non-operative management. Participants with isolated, closed AO/OTA type 22-A and B injuries, without extension into the proximal or distal radio-ulnar joints were approached for participation in a multi-centre, open-label, parallel randomized controlled trial (RCT). Those patients who refused randomization were given the opportunity to provide informed consent to participate in a parallel prospective cohort arm. Reason for non-participation in the RCT was collected, as well as Disabilities of Arm, Shoulder, and Hand (DASH) score, pain Visual Analogue Scale (VAS), ROM, grip strength, adverse events, and time-to-union (modified RUST score) until 12 months post-injury. Chi-squared, Wilcoxon rank sum, and Fisher's Exact test were used to compare between the groups. A total of 99 participants were randomized across 11 participating sites for the RCT analysis and 40 patients participated in the prospective cohort (PC) group. There were no differences between groups in age (41.0 years for RCT vs. 42.0 years for PC; p=0.7), sex (73% male for RCT vs. 62% for PC; p=0.2), or OTA/AO classification (p=0.2). A total of 29 participants (72.5%) in the PC group chose non-operative management. The most common reason for declining participation in the RCT was not wanting surgical treatment (61.1%), followed by a notable rationale that the patient had already been advised of one treatment over the other (19.4%). Additional concerns were surgical disruption of tattoos and the risk associated with surgery. The DASH score and pain VAS were not different between the RCT and the PC participants from 2-week to 12-month follow-up (all p < 0 .05). This comparative data suggests that patient education and engagement in participation in RCTs, as well as in surgical decision-making is important and that further investigation into patient decision aids are warranted.