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患者对不断演变的憩室炎治疗的看法:对患者参与随机对照试验意愿的评估

Patient Perspectives on Evolving Diverticulitis Treatment: An Assessment of Patient Willingness to Enroll in a Randomized Controlled Trial.

作者信息

Altman-Merino Annie, Bonnet Kemberlee, Schlundt David, Wrenn Jesse, Self Wesley H, Gordon Elisa J, Hawkins Alexander T

机构信息

From the Department of School of Medicine, Vanderbilt University, Nashville, TN.

Department of Psychology, Vanderbilt University, Nashville, TN.

出版信息

Ann Surg Open. 2024 Sep 5;5(3):e476. doi: 10.1097/AS9.0000000000000476. eCollection 2024 Sep.

DOI:10.1097/AS9.0000000000000476
PMID:39310344
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11415118/
Abstract

OBJECTIVE

The objective of the study was to assess patients' attitudes regarding participation in a randomized trial of antibiotics placebo for acute diverticulitis.

BACKGROUND

Despite evidence that antibiotics may not be necessary to treat acute uncomplicated diverticulitis, they remain the mainstay of treatment in the United States. A randomized trial in the United States evaluating antibiotic effectiveness could accelerate the implementation of antibiotic-free treatment, but providers maintain concerns that patients may be unwilling to participate.

METHODS

This mixed-methods study conducted semi-structured interviews of patients presenting to a quaternary care emergency department with acute diverticulitis and a web-based survey of a larger cohort. The interviews assessed patients' experiences with diverticulitis and perceptions of participation in a trial comparing antibiotics versus placebo. The survey quantified patients' willingness to participate in such a study and the relative importance of factors influencing the process.

RESULTS

Thirteen patients completed an interview. Reasons to participate included a desire to help others or contribute to scientific knowledge. Doubts about the efficacy of observation as a treatment method were the main barrier to participation. In a survey of 218 subjects, 62% of respondents reported willingness to participate in a randomized clinical trial. "What my doctor thinks," followed by "What I have experienced in the past" were the most important decision-making factors.

CONCLUSION

Patients with acute uncomplicated diverticulitis maintain complex and varying perceptions of antibiotic use. Most surveyed patients would be willing to participate in a trial of antibiotics placebo. Our findings support the trial's feasibility and may facilitate an informed approach to recruitment and consent.

摘要

目的

本研究的目的是评估患者对于参与急性憩室炎抗生素与安慰剂随机试验的态度。

背景

尽管有证据表明治疗急性非复杂性憩室炎可能无需使用抗生素,但在美国,抗生素仍是主要的治疗手段。在美国进行一项评估抗生素疗效的随机试验可能会加速无抗生素治疗的实施,但医疗服务提供者仍担心患者可能不愿参与。

方法

这项混合方法研究对到一家四级医疗急诊科就诊的急性憩室炎患者进行了半结构化访谈,并对更大的队列进行了基于网络的调查。访谈评估了患者患憩室炎的经历以及对参与抗生素与安慰剂对比试验的看法。该调查量化了患者参与此类研究的意愿以及影响这一过程的因素的相对重要性。

结果

13名患者完成了访谈。参与的理由包括希望帮助他人或为科学知识做出贡献。对观察作为一种治疗方法的疗效的怀疑是参与的主要障碍。在对218名受试者的调查中,62%的受访者表示愿意参与随机临床试验。“我的医生的看法”,其次是“我过去的经历”是最重要的决策因素。

结论

急性非复杂性憩室炎患者对抗生素使用的看法复杂且各不相同。大多数接受调查的患者愿意参与抗生素与安慰剂试验。我们的研究结果支持该试验的可行性,并可能有助于采取明智的招募和同意方式。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/4121f219a5bb/as9-5-e476-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/6851891c9855/as9-5-e476-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/e76adc9e1d22/as9-5-e476-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/4121f219a5bb/as9-5-e476-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/6851891c9855/as9-5-e476-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/e76adc9e1d22/as9-5-e476-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df88/11415118/4121f219a5bb/as9-5-e476-g003.jpg

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本文引用的文献

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AGA 临床实践更新:结肠憩室炎的医学管理:专家综述。
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Patient and Physician Preferences for Antibiotics in Acute Uncomplicated Diverticulitis: A Delphi Consensus Process to Generate Noninferiority Margins.患者和医生对急性单纯性憩室炎抗生素的偏好:生成非劣效性边界的德尔菲共识过程。
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The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Left-Sided Colonic Diverticulitis.美国结肠和直肠外科医师协会左侧结肠憩室炎治疗临床实践指南。
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