Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The VSports app下载. gov means it’s official. Federal government websites often end in . gov or . mil. Before sharing sensitive information, make sure you’re on a federal government site. .

Https

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. V体育官网.

. 2022 Dec 1;157(12):1080-1087.
doi: 10.1001/jamasurg.2022.4765.

"V体育ios版" Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial

Writing Group for the CODA Collaborative; Irene Y Zhang  1 , Emily C Voldal  1 , Giana H Davidson  1 , Joshua M Liao  1 , Callie M Thompson  2   3 , Wesley H Self  2 , Lillian S Kao  4 , Jill Cherry-Bukowiec  5 , Krishnan Raghavendran  5 , Amy H Kaji  6 , Daniel A DeUgarte  6 , Eva Gonzalez  6 , Katherine A Mandell  7 , Kristen Ohe  7 , Nicole Siparsky  8 , Thea P Price  8 , David C Evans  9 , Jesse Victory  10 , William Chiang  11 , Alan Jones  12 , Matthew E Kutcher  12 , Hailie Ciomperlik  13 , Mike K Liang  13   14 , Heather L Evans  15   16 , Brett A Faine  17 , Miriam Neufeld  18 , Sabrina E Sanchez  18 , Anusha Krishnadasan  19 , Bryan A Comstock  1 , Patrick J Heagerty  1 , Sarah O Lawrence  1 , Sarah E Monsell  1 , Erin E C Fannon  1 , Larry G Kessler  1 , David A Talan  19   20 , David R Flum  1
Collaborators, Affiliations

Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial (V体育安卓版)

Writing Group for the CODA Collaborative et al. JAMA Surg. .

Erratum in

Abstract

Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials VSports手机版. .

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. V体育安卓版.

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. V体育ios版.

Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful VSports最新版本. .

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. V体育平台登录.

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 VSports注册入口. 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 V体育官网入口. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. .

Trial registration: ClinicalTrials. gov Identifier: NCT02800785. VSports在线直播.

PubMed Disclaimer

VSports最新版本 - Conflict of interest statement

Conflict of Interest Disclosures: Dr Voldal reported receiving grants from the Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. Dr Liao reported receiving personal fees from Kaiser Permanente Washington Health Research Institute; honoraria from Wolters Kluwer, the Journal of Clinical Pathways, and the American College of Physicians; and grants from the National Institute of Aging all outside of this submitted work. Dr Thompson reported serving as a reviewer for the Shriner’s Research Fund and receiving personal fees from UpToDate. Dr Self reported receiving grants from PCORI during the conduct of the study. Dr Price reported having an association with Kerecis as a key opinion leader, Acera for research and a key opinion leader, and Medline for research and as a key opinion leader. Dr D. Evans reported receiving consulting fees from Tetraphase, consulting and speaking fees from Fresenius Kabi, and consulting and speaking fees from Abbott Laboratories outside the submitted work. Dr H. Evans reported receiving personal fees from Tetraphase outside the submitted work. Dr Faine reported receiving grants from Spero Therapeutics outside the submitted work. Dr Neufeld reported receiving grants from the National Institutes of Health outside the submitted work. Drs Heagerty, Monsell, Fannon, Kessler, and Flum reported receiving grants from PCORI during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Cumulative Incidence of Appendectomy After Being Randomly Assigned to Antibiotics, by Belief Group
Shaded regions correspond to 95% CIs. Cumulative incidence (95% CI) and number of participants still at risk for an appendectomy are shown at 48 hours and 30 days after randomization for each belief group. Ten participants were excluded from this figure for missing data on belief.
Figure 2.
Figure 2.. Association Between Belief and Appendectomy Within 30 Days With 95% CIs
Estimates are pooled from multiply imputed data sets. Baseline factors accounted for in the adjusted risk differences (RDs) were age, sex, body mass index, race, Hispanic ethnicity, health literacy help, education, low income or Medicaid/state program, average pain in the previous 7 days, appendiceal diameter, and appendicolith. Information on appendectomy status at 30 days was missing for 14 participants (eAppendix 4 in Supplement 3 for counts from complete case data).
Figure 3.
Figure 3.. Association Between Belief and Signs or Symptoms of Appendicitis Up to 30 Days With 95% CIs
Estimates are pooled from multiply imputed data sets. Baseline factors accounted for in the adjusted risk differences (RDs) were age, sex, body mass index, race, Hispanic ethnicity, health literacy help, education, low income or Medicaid/state program, average pain in the previous 7 days, appendiceal diameter, and appendicolith. Information on persistent signs and symptoms at 30 days was missing for 41 participants (eAppendix 4 in Supplement 3 for counts from complete case data).
Figure 4.
Figure 4.. Association Between Belief and High Regret or Dissatisfaction at 30 Days With 95% CIs
Estimates are pooled from multiply imputed data sets. Baseline factors accounted for in the adjusted risk differences (RDs) were age, sex, body mass index, race, Hispanic ethnicity, health literacy help, education, low income or Medicaid/state program, average pain in the previous 7 days, appendiceal diameter, and appendicolith. Information on regret or dissatisfaction at 30 days was missing for 50 participants (eAppendix 4 in Supplement 3 for counts from complete case data).
See this image and copyright information in PMC

V体育2025版 - Comment in

References

    1. Welliver C, Kottwitz M, Feustel P, McVary K. Clinically and statistically significant changes seen in sham surgery arms of randomized, controlled benign prostatic hyperplasia surgery trials. J Urol. 2015;194(6):1682-1687. doi:10.1016/j.juro.2015.06.091 - DOI - PubMed
    1. Roji R, Stone P, Ricciardi F, Candy B. Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression. BMJ Support Palliat Care. 2020;10(4):385-394. doi:10.1136/bmjspcare-2019-002163 - DOI - PMC - PubMed
    1. Musial F, Klosterhalfen S, Enck P. Placebo responses in patients with gastrointestinal disorders. World J Gastroenterol. 2007;13(25):3425-3429. doi:10.3748/wjg.v13.i25.3425 - DOI - PMC - PubMed
    1. Beasley MJ, Ferguson-Jones EA, Macfarlane GJ. Treatment expectations but not preference affect outcome in a trial of CBT and exercise for pain. Can J Pain. 2017;1(1):161-170. doi:10.1080/24740527.2017.1384297 - DOI - PMC - PubMed
    1. Davidson GH, Flum DR, Talan DA, et al. . Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment. BMJ Open. 2017;7(11):e016117. doi:10.1136/bmjopen-2017-016117 - DOI - PMC - PubMed

Substances

Associated data