Department of Radiation Oncology, Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor.
University of Michigan, Ann Arbor.
JAMA Oncol. 2022 Jun 1;8(6):887-894. doi: 10.1001/jamaoncol.2022.0114.
Understanding whether physicians accurately detect symptoms in patients with breast cancer is important because recognition of symptoms facilitates supportive care, and clinical trials often rely on physician assessments using Common Toxicity Criteria for Adverse Events (CTCAE).
To compare the patient-reported outcomes (PROs) of patients with breast cancer who received radiotherapy from January 1, 2012, to March 31, 2020, with physicians' CTCAE assessments to assess underrecognition of symptoms.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study included a total of 29 practices enrolled in the Michigan Radiation Oncology Quality Consortium quality initiative. Of 13 725 patients with breast cancer who received treatment with radiotherapy after undergoing lumpectomy, 9941 patients (72.4%) completed at least 1 PRO questionnaire during treatment with radiotherapy and were evaluated for the study. Of these, 9868 patients (99.3%) were matched to physician CTCAE assessments that were completed within 3 days of the PRO questionnaires.
Patient and physician ratings of 4 symptoms (pain, pruritus, edema, and fatigue) were compared.
We used multilevel multivariable logistic regression to evaluate factors associated with symptom underrecognition, hypothesizing that it would be more common in racial and ethnic minority groups.
Of 9941 patients, all were female, 1655 (16.6%) were Black, 7925 (79.7%) were White, and 361 (3.6%) had Other race and ethnicity (including American Indian/Alaska Native, Arab/Middle Eastern, and Asian), either as self-reported or as indicated in the electronic medical record. A total of 1595 (16.0%) were younger than 50 years, 2874 (28.9%) were age 50 to 59 years, 3353 (33.7%) were age 60 to 69 years, and 2119 (21.3%) were 70 years or older. Underrecognition of symptoms existed in 2094 of 6781 (30.9%) observations of patient-reported moderate/severe pain, 748 of 2039 observations (36.7%) of patient-reported frequent pruritus, 2309 of 4492 observations (51.4%) of patient-reported frequent edema, and 390 of 2079 observations (18.8%) of patient-reported substantial fatigue. Underrecognition of at least 1 symptom occurred at least once for 2933 of 5510 (53.2%) of those who reported at least 1 substantial symptom. Factors independently associated with underrecognition were younger age (younger than 50 years compared with 60-69 years: odds ratio [OR], 1.35; 95% CI, 1.14-1.59; P < .001; age 50-59 years compared with 60-69 years: OR, 1.19; 95% CI, 1.03-1.37; P = .02), race (Black individuals compared with White individuals: OR, 1.56; 95% CI 1.30-1.88; P < .001; individuals with Other race or ethnicity compared with White individuals: OR, 1.52; 95% CI, 1.12-2.07; P = .01), conventional fractionation (OR, 1.26; 95% CI, 1.10-1.45; P = .002), male physician sex (OR, 1.54; 95% CI, 1.20-1.99; P = .002), and 2-field radiotherapy (without a supraclavicular field) (OR, 0.80; 95% CI, 0.67-0.97; P = .02).
The results of this cohort study suggest that PRO collection may be essential for trials because relying on the CTCAE to detect adverse events may miss important symptoms. Moreover, since physicians in this study systematically missed substantial symptoms in certain patients, including younger patients and Black individuals or those of Other race and ethnicity, improving symptom detection may be a targetable mechanism to reduce disparities.
了解医生是否能准确识别乳腺癌患者的症状非常重要,因为症状的识别有助于提供支持性护理,且临床试验通常依赖于医生使用不良事件通用毒性标准(CTCAE)进行的评估。
比较 2012 年 1 月 1 日至 2020 年 3 月 31 日接受放射治疗的乳腺癌患者的患者报告结局(PRO)与医生的 CTCAE 评估,以评估症状识别不足的情况。
设计、地点和参与者:本队列研究共纳入了密歇根放射肿瘤质量联盟质量计划中 29 个实践。在接受保乳手术后接受放疗的 13725 例乳腺癌患者中,有 9941 例(72.4%)在接受放疗期间完成了至少 1 项 PRO 问卷,并纳入本研究进行评估。其中,9868 例(99.3%)患者与医生在 PRO 问卷完成后 3 天内完成的 CTCAE 评估相匹配。
患者和医生对 4 种症状(疼痛、瘙痒、水肿和疲劳)的评分进行了比较。
我们使用多水平多变量逻辑回归来评估与症状识别不足相关的因素,假设在少数族裔中这种情况更为常见。
在 9941 例患者中,均为女性,1655 例(16.6%)为黑人,7925 例(79.7%)为白人,361 例(3.6%)为其他种族和民族(包括美国印第安人/阿拉斯加原住民、阿拉伯/中东和亚洲),这些信息或为患者自报,或在电子病历中记录。共有 1595 例(16.0%)年龄小于 50 岁,2874 例(28.9%)年龄在 50 至 59 岁之间,3353 例(33.7%)年龄在 60 至 69 岁之间,2119 例(21.3%)年龄在 70 岁及以上。在 6781 次观察中,有 2094 次(30.9%)患者报告中度/重度疼痛,748 次(36.7%)患者报告瘙痒频繁,4492 次(51.4%)患者报告水肿频繁,2079 次(18.8%)患者报告疲劳明显。在报告至少 1 项严重症状的 5510 例患者中,至少有 1 项症状被漏诊的患者有 2933 例(53.2%)。与症状识别不足相关的独立因素包括年龄较小(年龄小于 50 岁与年龄 60-69 岁相比:比值比[OR],1.35;95%置信区间[CI],1.14-1.59;P<0.001;年龄 50-59 岁与年龄 60-69 岁相比:OR,1.19;95%CI,1.03-1.37;P=0.02)、种族(黑人与白人相比:OR,1.56;95%CI,1.30-1.88;P<0.001;其他种族与白人相比:OR,1.52;95%CI,1.12-2.07;P=0.01)、常规分割(OR,1.26;95%CI,1.10-1.45;P=0.002)、男性医生(OR,1.54;95%CI,1.20-1.99;P=0.002)和 2 野放疗(无锁骨上野)(OR,0.80;95%CI,0.67-0.97;P=0.02)。
本队列研究的结果表明,PRO 收集可能对试验至关重要,因为仅依赖 CTCAE 来检测不良事件可能会遗漏重要的症状。此外,由于该研究中的医生系统性地遗漏了某些患者的严重症状,包括年轻患者和黑人或其他种族和民族的患者,因此改善症状检测可能是减少差异的一个有针对性的机制。