Between June 15, 2005, and June 14, 2006, 190 consecutive patients with lung cancer were approached, of whom 185 were eligible and 163 consented to participate. Baseline characteristics are shown in . The median age was 63 years (range = 35–85 years). Most patients (69%) were diagnosed with advanced or metastatic non–small cell lung cancer, with predominantly good baseline provider–reported performance status. A majority of patients received cytotoxic chemotherapy in clinic once every 3 weeks. Mean enrollment was 12 months (range = 1–28 months), and the average number of clinic visits was 11 (range = 1–40). Sixty-seven (41%) of the 163 patients died during the study period. Twenty clinicians cared for these patients and documented their adverse symptoms in medical charts, including nine attending oncologists and 11 oncology nurses. The average number of patients cared for by any given oncologist was 16, with three oncologists treating fewer than 10 patients, three treating 10–20, and three treating 30–40. During the study, there were a total of 1712 clinic visits at which adverse symptom forms were submitted by patients at 1362 visits (80%) and by clinicians at 1601 visits (95%). Rates of missing data varied by symptom (). In general, rates of survey completion were higher among clinicians than patients. Reasons cited by patients for not completing forms included “no changes in symptoms from the previous time reporting” (56%), “inconvenient timing” (15%), “staff forgot to administer form” (14%), “felt too sick” (8%), and “did not feel like it” (6%). There was no effect of treatment type on compliance levels. At most visits, clinician documentation of adverse symptoms was completed by nurses (53%), followed by attending oncologists (38%), and oncology fellows (7%).
Proportion of patients and clinicians completing reports for each symptom at successive clinic visits
shows the cumulative incidence of attaining various severity levels of symptom items and performance status as reported by patients vs clinicians, with death considered as a competing risk. In general, each symptom severity level (ie, threshold) was reached earlier in the course of care and more frequently according to patient reports as opposed to clinician reports.
Figure 1 Cumulative incidence of symptoms and performance status as reported by patients vs clinicians and by month of follow-up, with death considered as a competing risk. A) Moderate (grade 2) or severe (grade 3) symptoms according to the National Cancer Institute's (more ...)
shows the associations of symptoms reported by patients or clinicians with the risk of death and the risk of emergency room visits. For the threshold of moderate fatigue in a univariate analysis, there was no relationship between patient self-reports and the risk of death (P = .23), whereas there was a highly statistically significant relationship for clinician reports of this symptom severity level (P < .001), with a hazard ratio for death of 2.75. The threshold was reached by a similar number of patients by each reporting approach, with a similar number of deaths among those reaching the threshold (46% and 48%). Raising the threshold to severe fatigue yielded similar results, with a non-statistically significant relationship for patient self-reports (P = .15), but a statistically significant relationship for clinician reports (P = .003), with a hazard ratio for death of 2.39. In this case, fewer patients reached the threshold by the clinician's report compared with the patient's report (37% vs 17%), yet a relatively higher proportion of those identified by clinicians as having severe fatigue died (57% vs 48%).
Associations of patient-reported or clinician-reported symptoms and performance status with risk of death or risk of ER admission (n = 163)*
A similar pattern was observed for the relationships of moderate nausea and constipation thresholds with the risk of death, with non-statistically significant relationships for patient reports (P
= .38 and P
= .40, respectively) and statistically significant relationships for clinician reports (P
= .01 and P
= .038, respectively). Too few reports of severe nausea or vomiting existed to conduct analyses of these thresholds. The pattern was repeated for KPS, for which clinician reports yielded the strongest observed association (hazard ratio = 6.39, 95% CI 3.88 to 11.08; P
< .001) compared with patient reports (hazard ratio = 1.40, 95% CI = 0.84 to 2.35; P
= .20). The cutoff KPS score of 70 or less [defined as “cares for self; unable to carry on normal activity or to do active work” (30
)] was the most predictive threshold, although other cutoffs yielded similar results. Notably, worse survival was seen in patients for whom clinicians reported severe nausea, pain, fatigue, or KPS score of 70 or less during the initial month of observation (with a median survival time of 12 months) compared with patients for whom severe grades were not assigned (who did not reach a median survival time during the study).
Analyses were generally not informative for symptoms when using mild as a threshold (because of commonness at baseline by both patient and clinician reports) or when using disabling as a threshold (because of its overall rarity in this outpatient population). Too few events existed for any threshold levels of vomiting or diarrhea to conduct analyses of these symptoms. No effect on any estimates by patient characteristics including sex, age, education level, clinician type (physician or nurse), treating oncologist, disease stage, or chemotherapy type was observed.
A sensitivity analysis evaluated the associations between the second time patients reached each severity threshold and the outcomes of interest, and results were similar. In a bivariate analysis, patient-reported data did not augment the predictive ability of clinician reporting. In a multivariable model that included all items, KPS dominated in its ability to predict the measured endpoints.
Results were similar for the association of symptom thresholds with risk of emergency room admission, with statistically significant relationships observed for clinician-reported moderate fatigue, pain, and KPS thresholds but not for patient reports. There were too few events for other thresholds to conduct analyses.
shows the relative strengths of concordance between patient-reported and clinician-reported CTCAE symptoms and KPS with the two validated measures of health status (EuroQoL EQ-5D questionnaire and 0–100 global question). In general, higher levels of concordance were seen for patient reports compared with clinician reports. Results were more pronounced for EQ-5D scores, which were measured at each sequential clinic visit, compared with 0–100 global question scores, which were measured only at baseline.
Figure 2 Relative strengths of concordance of patient-reported and clinician-reported Karnofsky Performance Status and symptoms with two measures of health status (28,29). A) Concordance with EuroQoL EQ-5D questionnaire scores. B) Concordance with 0–100 (more ...)