Congruence of patient‐ and clinician‐reported toxicity in women receiving chemotherapy for early breast cancer

Abstract

Background The National Cancer Institute's Patient‐Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, collected alongside the clinician‐reported Common Terminology Criteria for Adverse Events, enables comparisons of patient and clinician reports on treatment toxicity. Methods In a multisite study of women receiving chemotherapy for early‐stage breast cancer, symptom reports were collected on the same day from patients and their clinicians for 17 symptoms; their data were not shared with each other. The proportions of moderate, severe, or very severe patient‐reported symptom severity were compared with the proportions of clinician‐rated grade 2, 3, or 4 toxicity. Patient‐clinician agreement was assessed via κ statistics. Chi‐square tests investigated whether patient characteristics were associated with patient‐clinician agreement. Results Among 267 women, the median age was 58 years (range, 24‐83 years), and 26% were nonwhite. There was moderate scoring agreement (κ = 0.413‐0.570) for 53% of symptoms, fair agreement for 41% (κ = 0.220‐0.378), and slight agreement for 6% (κ = 0.188). For example, patient‐reported and clinician‐rated percentages were 22% and 8% for severe or very severe fatigue, 41% and 46% for moderate fatigue, 32% and 39% for mild fatigue, and 6% and 7% for none. Clinician severity scores were lower for nonwhite patients in comparison with white patients for peripheral neuropathy, nausea, arthralgia, and dyspnea. Conclusions Although clinician reporting of symptoms is common practice in oncology, there is suboptimal agreement with the gold standard of patient self‐reporting. These data provide further evidence supporting the integration of patient‐reported outcomes into oncological clinical research and clinical practice to improve monitoring of symptoms as well as timely interventions for symptoms.

The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial

“…Overall, we found fair agreement for long-lasting symptoms, whereas for the more recent symptoms (defined as those recorded 1-7 days earlier), the degree of agreement in symptom reporting between the patient and physician was moderate and comparable to results from a study in early breast cancer [ 19 ]. However, the congruence between patients and physicians gained substantial reliability when analyses on levels of agreement in subgroups of the specific symptoms (ie, pain, fever, diarrhea, obstipation, nausea, vomiting, and stomatitis) were performed and also in an identical manner to that in the most frequently occurring symptoms, including fatigue, hot flashes, sleep disorder, headache, and taste disorder.…”

Patient‐reported symptom severity, interference with daily activities, and adverse events in older and younger women receiving chemotherapy for early breast cancer

“…Although the women in the current study scored symptom interference as consistently lower than symptom severity, the high prevalence of moderate or higher symptom severity in both age groups underscores the importance of ongoing symptom monitoring in patients of all ages and communication regarding symptom management with the treatment team 30,31 . It is perhaps easier for patients to communicate that a symptom is interfering with their daily activities rather than convey the absolute severity of a symptom, which may explain why clinicians are reported to often underestimate actual symptom intensity 18 …”

“…We previously observed that patient‐reported symptom severity varies significantly among 4 chemotherapy regimens commonly used in current clinical practice for the treatment of early breast cancer, and that patients receiving anthracycline‐based regimens had significantly higher rates of moderate, severe, or very severe (MSVS) symptoms compared with patients receiving regimens that were not anthracycline based 17 . In this sample of patients, we also observed that clinicians often underestimate the severity of chemotherapy side effects compared with patient reports of symptom severity 18 …”

“…For all 3 studies, women with histologically confirmed state I to stage III breast cancer 20 who were scheduled to receive (neo)adjuvant chemotherapy were approached in the clinic, confirmed for eligibility (clinician consent to engage in moderate walking), and invited to participate by providing written informed consent meeting all federal, state, and institutional guidelines. Further details regarding the patient population have been published previously 17,18,21 …”

Assessing concordance between patient-reported and investigator-reported CTCAE after proton beam therapy for prostate cancer

“…Recently, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) has been developed as a novel, validated, and reliable method for reporting patient-reported adverse events [14][15][16][17]. Because investigator-reported CTCAE (IR-CTCAE) often under-detects symptomatic adverse events, PRO-CTCAE can be used to enhance the precision and patientcenteredness of adverse event reporting in cancer clinical research [18,19]. In this study, we report acute PRO-CTCAE of proton beam therapy for patients with high or unfavorable-intermediate risk prostate cancer who received radiotherapy to the prostate/seminal vesicles and the regional pelvic lymph nodes in a prospective clinical trial.…”