Exploring methods of improving patient understanding and communication in a complex anal fistula clinic: results from a randomized controlled feasibility study.

AIM: Patient understanding of disease can guide decision-making in the management of anal fistula. This prospective feasibility study aimed to assess the acceptability and methods of assessing the impact of viewing realistic models on patients with anal fistula.

METHODS

New referrals to a tertiary clinic participated in this single-centre, parallel-group randomized controlled study. Baseline characteristics, Decisional Conflict Scale and understanding of disease were assessed pre-consultation. Participants were randomized to a standard consultation, where disease and treatment options were explained using magnetic resonance images and drawn diagrams, or a similar consultation supplemented with an appropriate generic three-dimensional (3D) printed model. Understanding of disease and proposed surgery, Decisional Conflict Scale and ratings of visual aids were assessed post-consultation, along with 3D model feedback.

RESULTS

All 52 patients who were approached agreed to be randomized (25 standard, 27 3D consultation). Understanding of disease increased post-consultation in both groups. Post-consultation decisional conflict (0, no; 100, high decisional conflict) was low (median 27 post-standard vs. 24 post-3D consultation). Patients scored highly on measures assessing understanding of proposed surgery. 3D models were rated highly, with 96% of patients wanting to see them again in future consultations.

CONCLUSIONS

Three-dimensional printed fistula models are a welcome addition to outpatient consultations with results suggesting that understanding of surgery is improved. A future trial should be powered to detect whether 3D models result in a significant improvement in understanding beyond traditional methods of explanation and explore the conditions in which models have their maximal utility.

GOV REGISTRATION ID: This study was registered on ClinicalTrials.gov (ID: NCT04069728). Registered on 23 August 2019.