Department of Surgery, Surgical Outcomes Research Center, University of Washington, Seattle.
Vanderbilt University Medical Center, Nashville, Tennessee.
JAMA Surg. 2022 Dec 1;157(12):1080-1087. doi: 10.1001/jamasurg.2022.4765.
A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials.
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.
Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT02800785.
患者对治疗成功可能性的信念可能会影响治疗结果，但这在外科试验中研究得还不够充分。
研究 CODA 试验中患者对治疗成功可能性的基线信念与抗生素治疗阑尾炎结果之间的关联。
设计、地点和参与者：这是 CODA 随机临床试验的二次分析。来自 25 家美国医疗中心的参与者于 2016 年 5 月 3 日至 2020 年 2 月 5 日期间入组。分析纳入了患有阑尾炎并随机分配接受 CODA 试验中抗生素治疗的参与者。在知情同意但在随机分组之前，接受抗生素治疗的参与者回答了一项基线调查，其中包括一个关于他们认为抗生素治疗他们的阑尾炎可能成功的问题。
根据基线调查的回答，参与者被分为 3 个信念组之一：不成功/不确定、中间和完全成功。
在 30 天时，分配了 3 个结局：（1）阑尾切除术，（2）高度决策后悔或对治疗不满，（3）持续存在的体征和症状（腹痛、压痛、发热或寒战）。使用调整后的风险差异（aRD），并对社会人口统计学和临床因素进行倾向评分调整，比较各组之间的结局。
在 CODA 中被分配抗生素治疗的 776 名研究参与者中，共有 425 名（平均[SD]年龄，38.5[13.6]岁；277 名男性[65%]）在知道治疗分配之前完成了基线信念调查。基线信念如下：22%的参与者（92/415）有不成功/不确定的反应，51%（212/415）有中间反应，27%（111/415）有完全成功的反应。与不成功/不确定组相比，那些认为抗生素可以完全成功的患者阑尾切除术风险降低了 13 个百分点（aRD，-13.49；95%CI，-24.57 至-2.40）。中间组与不成功/不确定组相比，aRD 为-5.68（95%CI，-16.57 至 5.20）。与不成功/不确定组相比，中间信念组持续存在体征和症状的风险较低（aRD，-15.72；95%CI，-29.71 至-1.72），完全成功组也有类似的方向结果（aRD，-15.14；95%CI，-30.56 至 0.28）。
对阑尾炎抗生素治疗可能成功的积极信念与阑尾切除术风险降低以及 30 天内体征和症状缓解相关。信念与结局之间的相关途径以及信念的潜在可改变性以改善结局值得进一步研究。
ClinicalTrials.gov 标识符：NCT02800785。
