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评价基于国家综合癌症网络指南的决策支持工具在非小细胞肺癌患者中的应用:一项非随机临床试验。

Evaluation of a National Comprehensive Cancer Network Guidelines-Based Decision Support Tool in Patients With Non-Small Cell Lung Cancer: A Nonrandomized Clinical Trial.

机构信息

Department of Radiation Oncology, University of California, San Francisco.

Department of Epidemiology and Biostatistics, University of California, San Francisco.

出版信息

JAMA Netw Open. 2020 Sep 1;3(9):e209750. doi: 10.1001/jamanetworkopen.2020.9750.

Abstract

IMPORTANCE

The association of guideline-based decision support with the quality of care in patients with non-small cell lung cancer (NSCLC) is not known.

OBJECTIVE

To evaluate the association of exposure to the National Comprehensive Cancer Center (NCCN) guidelines with guideline-concordant care and patients' decisional conflict.

DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized clinical trial, conducted at a tertiary care academic institution, enrolled patients from February 23, 2015, to September 28, 2017. Data analysis was conducted from July 19, 2019, to April 22, 2020. A cohort of 76 patients with NSCLC seen at diagnosis or disease progression and a retrospective cohort of 157 patients treated before the trial were included. Adherence to 6 NCCN recommendations were evaluated: (1) smoking cessation counseling, (2) adjuvant chemotherapy for patients with stage IB to IIB NSCLC after surgery, (3) pathologic mediastinal staging in patients with stage III NSCLC before surgery, (4) pathologic mediastinal staging in patients with stage III NSCLC before nonsurgical treatment, (5) definitive chemoradiotherapy for patients with stage III NSCLC not having surgery, and (6) molecular testing for epidermal growth factor receptor and anaplastic lymphoma kinase alterations for patients with stage IV NSCLC. Subgroup analysis was conducted to compare the rates of guideline concordance between the prospective and retrospective cohorts. Secondary end points included decisional conflict and satisfaction.

INTERVENTIONS

An online tool customizing the NCCN guidelines to patients' clinical and pathologic features was used during consultation, facilitated by a trained coordinator.

MAIN OUTCOMES AND MEASURES

Concordance of practice with 6 NCCN treatment recommendations on NSCLC and patients' decisional conflict.

RESULTS

Of the 76 patients with NSCLC, 44 were men (57.9%), median age at diagnosis was 68 years (interquartile range [IQR], 41-87 years), and 59 patients (77.6%) had adenocarcinoma. In the retrospective cohort, 91 of 157 patients (58.0%) were men, median age at diagnosis was 66 years (IQR, 61-65 years), and 105 patients (66.9%) had adenocarcinoma. After the intervention, patients received more smoking cessation counseling (4 of 5 [80.0%] vs 1 of 24 [4.2%], P < .001) and less adjuvant chemotherapy (0 of 7 vs 7 of 11 [63.6%]; P = .012). There was no significant change in mutation testing of non-squamous cell stage IV disease (20 of 20 [100%] vs 48 of 57 [84.2%]; P = .10). There was no significant change in pathologic mediastinal staging or initial chemoradiotherapy for patients with stage III disease. After consultation with the tool, decisional conflict scores improved by a median of 20 points (IQR, 3-34; P < .001).

CONCLUSIONS AND RELEVANCE

The findings of this study suggest that exposure to the NCCN guidelines is associated with increased guideline-concordant care for 2 of 6 preselected recommendations and improvement in decisional conflict.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03982459.

摘要

重要性

非小细胞肺癌(NSCLC)患者的基于指南的决策支持与护理质量之间的关联尚不清楚。

目的

评估接触国家综合癌症网络(NCCN)指南与指南一致的护理和患者决策冲突之间的关联。

设计、设置和参与者:在三级护理学术机构进行的非随机临床试验,从 2015 年 2 月 23 日至 2017 年 9 月 28 日招募患者。数据分析于 2019 年 7 月 19 日至 2020 年 4 月 22 日进行。包括在诊断或疾病进展时就诊的 76 例 NSCLC 患者队列和在试验前接受治疗的 157 例回顾性队列。评估了 6 项 NCCN 建议的依从性:(1)对吸烟的咨询,(2)手术后 IB 期至 IIB 期 NSCLC 患者的辅助化疗,(3)手术前 III 期 NSCLC 患者的病理纵隔分期,(4)手术前 III 期 NSCLC 患者的病理纵隔分期,(5)无手术治疗的 III 期 NSCLC 患者的确定性放化疗,(6)IV 期 NSCLC 患者的表皮生长因子受体和间变性淋巴瘤激酶改变的分子检测。进行了亚组分析,以比较前瞻性和回顾性队列之间的指南一致性率。次要终点包括决策冲突和满意度。

干预措施

在培训协调员的协助下,使用定制患者临床和病理特征的 NCCN 指南的在线工具进行咨询。

主要结果和措施

6 项 NSCLC 治疗建议与实践的一致性和患者的决策冲突。

结果

76 例 NSCLC 患者中,44 例为男性(57.9%),诊断时中位年龄为 68 岁(四分位距[IQR],41-87 岁),59 例(77.6%)为腺癌。在回顾性队列中,157 例患者中有 91 例(58.0%)为男性,诊断时中位年龄为 66 岁(IQR,61-65 岁),105 例(66.9%)为腺癌。干预后,患者接受了更多的戒烟咨询(4/5 [80.0%] vs 1/24 [4.2%],P <.001)和更少的辅助化疗(0/7 vs 7/11 [63.6%];P =.012)。非鳞状细胞 IV 期疾病的突变检测没有明显变化(20/20 [100%] vs 48/57 [84.2%];P =.10)。III 期疾病患者的病理纵隔分期或初始放化疗没有明显变化。使用工具咨询后,决策冲突评分中位数提高了 20 分(IQR,3-34;P <.001)。

结论和相关性

这项研究的结果表明,接触 NCCN 指南与 6 项预先选定建议中的 2 项更一致的护理和决策冲突的改善有关。

试验注册

ClinicalTrials.gov 标识符:NCT03982459。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9766/7527870/d74fc89593b6/jamanetwopen-e209750-g001.jpg

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