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随机对照试验研究计算机辅助决策对早期甲状腺乳头状癌患者辅助放射性碘治疗的影响。

Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early-stage papillary thyroid cancer.

机构信息

University Health Network and University of Toronto, Toronto General Hospital, 200 Elizabeth St, 12 EN-212, Toronto, Ontario, Canada M5G 2C4.

出版信息

J Clin Oncol. 2012 Aug 10;30(23):2906-11. doi: 10.1200/JCO.2011.41.2734. Epub 2012 Jul 2.

DOI:10.1200/JCO.2011.41.2734
PMID:22753906
Abstract

PURPOSE

Decision-making on adjuvant radioactive iodine (RAI) treatment for early-stage papillary thyroid cancer (PTC) is complex because of uncertainties in medical evidence. Using a parallel, two-arm, randomized, controlled trial design, we examined the impact of a patient-directed computerized decision aid (DA) on the medical knowledge and decisional conflict in patients with early-stage PTC considering the choice of being treated with adjuvant RAI or not. The DA describes the rationale, possible risks and benefits, and the medical evidence uncertainty relating to the choice.

PATIENTS AND METHODS

We recruited 74 patients with early-stage PTC after thyroidectomy. Participants were assigned by using 1:1 central computerized randomization to either the DA group with usual care (intervention) or usual care alone (control). Medical knowledge about PTC and RAI treatment (the primary outcome), as well as decisional conflict (a secondary outcome), were measured by using validated questionnaires, and the respective scores were compared between groups.

RESULTS

Consistent with PTC epidemiology, 83.8% (62 of 74) of the participants were women, and the mean age was 45.8 years (range, 19 to 79 years). Medical knowledge about PTC and RAI treatment was significantly greater and decisional conflict was significantly reduced in the DA group compared with the control group (respective P values < .001). The use of adjuvant RAI treatment was not significantly different between groups (DA group, 11 of 37 [29.7%]; controls, seven of 37 [18.9%]; P = .278).

CONCLUSION

A computerized DA improves informed decision making in patients with early-stage PTC who are considering adjuvant RAI treatment. DAs are useful for patients facing decisions subject to medical evidence uncertainty.

摘要

目的

由于医学证据存在不确定性,因此在决定早期甲状腺乳头状癌(PTC)患者是否进行辅助放射性碘(RAI)治疗时,决策非常复杂。本研究采用平行、双臂、随机、对照试验设计,通过评估患者导向的计算机化决策辅助工具(DA)对考虑是否接受辅助 RAI 治疗的早期 PTC 患者的医学知识和决策冲突的影响,来研究该工具的作用。DA 描述了与选择是否接受辅助 RAI 治疗相关的选择依据、可能的风险和获益以及医学证据的不确定性。

患者和方法

本研究在甲状腺切除术后招募了 74 例早期 PTC 患者。使用 1:1 中央计算机化随机分组,将患者分为 DA 组(干预组)和常规护理组(对照组)。通过使用经过验证的调查问卷来测量患者的 PTC 和 RAI 治疗相关的医学知识(主要结局)和决策冲突(次要结局),并比较两组之间的评分。

结果

符合 PTC 流行病学特征,83.8%(62/74)的参与者为女性,平均年龄为 45.8 岁(19-79 岁)。与对照组相比,DA 组患者的 PTC 和 RAI 治疗相关医学知识明显提高,决策冲突明显降低(相应的 P 值均<0.001)。两组患者辅助 RAI 治疗的使用率无显著差异(DA 组 37 例中有 11 例[29.7%];对照组 37 例中有 7 例[18.9%];P=0.278)。

结论

计算机化 DA 可改善考虑辅助 RAI 治疗的早期 PTC 患者的知情决策。对于面临受医学证据不确定性影响的决策的患者,DA 非常有用。

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