JAMA network open · 2025
Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Khan Aimal, Sellyn Georgina E, Ali Danish, Moazzam Zorays, Samaras Hillary, McChesney Shannon L, Hopkins Michael B, Ford Molly M, Muldoon Roberta L, Geiger Timothy M, Martin Dann, Chu Daniel I, VanKoevering Kyle K, Hawkins Alexander T
Аннотация
IMPORTANCE: Patients undergoing surgery report a lack of involvement in health care decisions and increased anxiety. Three-dimensional (3D)-printed models serve as educational tools to encourage patient engagement, reduce anxiety levels, and aid understanding.
OBJECTIVE: To determine the impact of 3D-printed anatomic models on shared decision-making (SDM) and patient anxiety during the preoperative surgical consultation for colon or rectal resection.
DESIGN, SETTING, AND PARTICIPANTS: This single-center cluster randomized clinical trial was conducted from March 2022 to June 2023 at a colorectal surgery clinic at an academic medical institution and included adult patients scheduled for partial or complete colon and/or rectal resection for colorectal cancer, diverticular disease, or inflammatory bowel disease.
INTERVENTION: Six surgeons (clusters) were randomized to counsel patients using a modular 3D-printed model or providing usual care during preoperative clinic visits.
MAIN OUTCOMES AND MEASURES: The primary outcome was the patient's perception of involvement in decision-making using the 9-item Shared Decision Making Questionnaire. The secondary outcome was the change in anxiety level measured using the State-Trait Anxiety Inventory. Patient characteristics were compared between the 3D-printed model and usual care arms using a χ2 test for categorical variables and a t test for comparisons between continuous variables.
RESULTS: Among the 51 patients enrolled (mean [SD] age, 50.7 [14.5] years; 28 female [54.9%]), 28 (54.9%) were in the 3D-printed model arm and 23 (45.1%) were in the usual care arm. Patients counseled with the 3D-printed model reported a significantly higher involvement in SDM compared with those in the usual care group (mean [SD] score, 89.5 [17.6] vs 80.5 [14.4]; P = .01). Additionally, using a 3D-printed model significantly reduced mean anxiety scores (from 53.5 [SD, 21.2] to 44.1 [SD, 15.8]) compared with conventional methods (from 50.4 [SD, 18.3] to 48.0 [SD, 15.3]) (P = .04).
CONCLUSIONS AND RELEVANCE: This cluster randomized clinical trial found that counseling aided with 3D models during preoperative clinic visits improved SDM among patients undergoing colorectal surgery. This study highlights the potential of 3D-printed models as a tool to enhance patient-clinician collaborations. Given the findings, further research into the effectiveness and implementation of these tools is recommended in more diverse clinical settings.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06625008.
OBJECTIVE: To determine the impact of 3D-printed anatomic models on shared decision-making (SDM) and patient anxiety during the preoperative surgical consultation for colon or rectal resection.
DESIGN, SETTING, AND PARTICIPANTS: This single-center cluster randomized clinical trial was conducted from March 2022 to June 2023 at a colorectal surgery clinic at an academic medical institution and included adult patients scheduled for partial or complete colon and/or rectal resection for colorectal cancer, diverticular disease, or inflammatory bowel disease.
INTERVENTION: Six surgeons (clusters) were randomized to counsel patients using a modular 3D-printed model or providing usual care during preoperative clinic visits.
MAIN OUTCOMES AND MEASURES: The primary outcome was the patient's perception of involvement in decision-making using the 9-item Shared Decision Making Questionnaire. The secondary outcome was the change in anxiety level measured using the State-Trait Anxiety Inventory. Patient characteristics were compared between the 3D-printed model and usual care arms using a χ2 test for categorical variables and a t test for comparisons between continuous variables.
RESULTS: Among the 51 patients enrolled (mean [SD] age, 50.7 [14.5] years; 28 female [54.9%]), 28 (54.9%) were in the 3D-printed model arm and 23 (45.1%) were in the usual care arm. Patients counseled with the 3D-printed model reported a significantly higher involvement in SDM compared with those in the usual care group (mean [SD] score, 89.5 [17.6] vs 80.5 [14.4]; P = .01). Additionally, using a 3D-printed model significantly reduced mean anxiety scores (from 53.5 [SD, 21.2] to 44.1 [SD, 15.8]) compared with conventional methods (from 50.4 [SD, 18.3] to 48.0 [SD, 15.3]) (P = .04).
CONCLUSIONS AND RELEVANCE: This cluster randomized clinical trial found that counseling aided with 3D models during preoperative clinic visits improved SDM among patients undergoing colorectal surgery. This study highlights the potential of 3D-printed models as a tool to enhance patient-clinician collaborations. Given the findings, further research into the effectiveness and implementation of these tools is recommended in more diverse clinical settings.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06625008.