Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial.
Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial.
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DOI：
10.1001/jamasurg.2022.4765
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发表时间：
2022-12-01
期刊：
影响因子：
16.9
通讯作者：
Flum DR
中科院分区：
文献类型：
--
作者：
Writing Group for the CODA Collaborative;Zhang IY;Voldal EC;Davidson GH;Liao JM;Thompson CM;Self WH;Kao LS;Cherry-Bukowiec J;Raghavendran K;Kaji AH;DeUgarte DA;Gonzalez E;Mandell KA;Ohe K;Siparsky N;Price TP;Evans DC;Victory J;Chiang W;Jones A;Kutcher ME;Ciomperlik H;Liang MK;Evans HL;Faine BA;Neufeld M;Sanchez SE;Krishnadasan A;Comstock BA;Heagerty PJ;Lawrence SO;Monsell SE;Fannon EEC;Kessler LG;Talan DA;Flum DR
这项对抗生素药物与阑尾切除术（CODA）随机临床试验结果比较的二次分析调查了阑尾炎患者对治疗成功的信念与抗生素治疗结果之间的关系。当使用抗生素治疗阑尾炎时，患者对治疗成功的信念如何与结果相关？对抗生素药物与阑尾切除术结果比较（CODA）随机临床试验425名参与者的二次分析发现，在基线时对阑尾炎抗生素治疗成功的积极信念与抗生素治疗后阑尾切除术风险的显著降低以及30天内体征和症状的缓解相关。在决定阑尾炎治疗时，了解患者对治疗成功的信念可能很重要；将信念与结果联系起来的途径以及信念改善结果的潜在可修改性值得进一步研究。患者对治疗可能成功的信念可能会影响结果，但这在外科试验中尚未得到充分研究。在抗生素药物与阑尾切除术（CODA）结果比较试验中，研究患者对阑尾炎治疗成功可能性的基线信念与抗生素治疗结果之间的关系。这是CODA随机临床试验的二次分析。来自25个美国医疗中心的参与者在2016年5月3日至2020年2月5日期间被招募。纳入分析的是在CODA试验中随机分配接受抗生素治疗的阑尾炎患者。在知情同意后但在随机化之前，被分配接受抗生素的参与者回答了一项基线调查，其中包括他们认为抗生素治疗阑尾炎的成功程度。参与者根据基线调查结果分为三个信念组：不成功/不确定、中等和完全成功。在第30天分配了三个结果：(1)阑尾切除术，(2)对治疗的高度决定后悔或不满意，(3)持续的体征和症状（腹痛、压痛、发烧或寒战）。使用调整后的风险差异（aRDs）对各组结果进行比较，并对社会人口统计学和临床因素进行倾向评分调整。在接受CODA抗生素治疗的776名研究参与者中，共有425人（平均[SD]年龄，38.5[13.6]岁；277名男性[65%]）在知道他们的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（415名中的92名）有不成功/不确定的反应，51%（415名中的212名）有中间反应，27%（415名中的111名）有完全成功的反应。与不成功/不确定组相比，那些相信抗生素可以完全成功的患者阑尾切除术的风险降低了13个百分点（aRD, - 13.49; 95% CI, - 24.57至- 2.40）。中间信念与不成功信念/不确定信念之间的aRD为- 5.68 （95% CI, - 16.57至5.20）。与不成功/不确定组相比，具有中等信念的患者出现持续体征和症状的风险较低（平均生存率，−15.72;95% CI,−29.71至−1.72），完全成功组的结果方向相似（平均生存率，−15.14;95% CI,−30.56至0.28）。患者对抗生素治疗阑尾炎可能成功的积极信念与阑尾切除术的风险较低以及症状和体征在30天内的缓解有关。将信念与结果联系起来的途径以及信念改善结果的潜在可修改性值得进一步研究。ClinicalTrials.gov标识符：NCT02800785
This secondary analysis of the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial investigates the association between patients’ belief in treatment success and outcomes regarding antibiotic management for appendicitis. How are patients’ beliefs about treatment success associated with outcomes when using antibiotics for the treatment of appendicitis? The secondary analysis of the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial of 425 participants found that positive beliefs at baseline about the success of antibiotics for appendicitis were associated with a substantially lower risk of appendectomy after antibiotics and with resolution of signs and symptoms by 30 days. Understanding patients’ beliefs about treatment success when making decisions about treatment for appendicitis may be important; pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. 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. 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
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