Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials. Objective: To examine the association between patients' baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial. Design, Setting, and Participants: This was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis. Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful. Main Outcomes and Measures: Three outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors. Results: Of the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13-percentage point lower risk of appendectomy (aRD, -13.49; 95% CI, -24.57 to -2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was -5.68 (95% CI, -16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, -15.72; 95% CI, -29.71 to -1.72), with directionally similar results for the completely successful group (aRD, -15.14; 95% CI, -30.56 to 0.28). Conclusions and Relevance: Positive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.
Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials. Objective: To examine the association between patients' baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial. Design, Setting, and Participants: This was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis. Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful. Main Outcomes and Measures: Three outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors. Results: Of the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13-percentage point lower risk of appendectomy (aRD, -13.49; 95% CI, -24.57 to -2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was -5.68 (95% CI, -16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, -15.72; 95% CI, -29.71 to -1.72), with directionally similar results for the completely successful group (aRD, -15.14; 95% CI, -30.56 to 0.28). Conclusions and Relevance: Positive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.
Authors: Callie M Thompson; Emily C Voldal; Giana H Davidson; Sabrina E Sanchez; Patricia Ayoung-Chee; Jesse Victory; Mary Guiden; Bonnie Bizzell; Jacob Glaser; Christopher Hults; Thea P Price; Nicole Siparsky; Kristin Ohe; Katherine A Mandell; Daniel A DeUgarte; Amy H Kaji; Lisandra Uribe; Lillian S Kao; Krislynn M Mueck; Farhood Farjah; Wesley H Self; Sunday Clark; F Thurston Drake; Katherine Fischkoff; Elizaveta Minko; Joseph Cuschieri; Brett Faine; Dionne A Skeete; Naila Dhanani; Mike K Liang; Anusha Krishnadasan; David A Talan; Erin Fannon; Larry G Kessler; Bryan A Comstock; Patrick J Heagerty; Sarah E Monsell; Sarah O Lawrence; David R Flum; Danielle C Lavallee Journal: Ann Surg Date: 2022-07-11 Impact factor: 13.787
Authors: David R Flum; Giana H Davidson; Sarah E Monsell; Nathan I Shapiro; Stephen R Odom; Sabrina E Sanchez; F Thurston Drake; Katherine Fischkoff; Jeffrey Johnson; Joe H Patton; Heather Evans; Joseph Cuschieri; Amber K Sabbatini; Brett A Faine; Dionne A Skeete; Mike K Liang; Vance Sohn; Karen McGrane; Matthew E Kutcher; Bruce Chung; Damien W Carter; Patricia Ayoung-Chee; William Chiang; Amy Rushing; Steven Steinberg; Careen S Foster; Shaina M Schaetzel; Thea P Price; Katherine A Mandell; Lisa Ferrigno; Matthew Salzberg; Daniel A DeUgarte; Amy H Kaji; Gregory J Moran; Darin Saltzman; Hasan B Alam; Pauline K Park; Lillian S Kao; Callie M Thompson; Wesley H Self; Julianna T Yu; Abigail Wiebusch; Robert J Winchell; Sunday Clark; Anusha Krishnadasan; Erin Fannon; Danielle C Lavallee; Bryan A Comstock; Bonnie Bizzell; Patrick J Heagerty; Larry G Kessler; David A Talan Journal: N Engl J Med Date: 2020-10-05 Impact factor: 91.245
Authors: Winfried Rief; Meike C Shedden-Mora; Johannes A C Laferton; Charlotte Auer; Keith J Petrie; Stefan Salzmann; Manfred Schedlowski; Rainer Moosdorf Journal: BMC Med Date: 2017-01-10 Impact factor: 8.775
Authors: Giana H Davidson; David R Flum; David A Talan; Larry G Kessler; Danielle C Lavallee; Bonnie J Bizzell; Farhood Farjah; Skye D Stewart; Anusha Krishnadasan; Erin E Carney; Erika M Wolff; Bryan A Comstock; Sarah E Monsell; Patrick J Heagerty; Annie P Ehlers; Daniel A DeUgarte; Amy H Kaji; Heather L Evans; Julianna T Yu; Katherine A Mandell; Ian C Doten; Kevin S Clive; Karen M McGrane; Brandon C Tudor; Careen S Foster; Darin J Saltzman; Richard C Thirlby; Erin O Lange; Amber K Sabbatini; Gregory J Moran Journal: BMJ Open Date: 2017-11-15 Impact factor: 2.692