Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes.

BACKGROUND: In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood. METHODS: Patients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided. RESULTS: A total of 163 patients were enrolled for an average of 12 months (range = 1-28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P < .001), nausea (P = .01), constipation (P = .038), and Karnofsky Performance Status (P < .001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms. CONCLUSIONS: Longitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are complementary, each providing clinically meaningful information. Inclusion of both types of data in treatment trial results and drug labels appears to be warranted.

An interdisciplinary consensus on managing skin reactions associated with human epidermal growth factor receptor inhibitors.

The use of human epidermal growth factor receptor (HER1/EGFR) inhibitors, such as erlotinib, cetuximab, and panitumumab, often is accompanied by the development of a characteristic spectrum of skin toxicities. Although these toxicities rarely are life threatening, they can cause physical and emotional distress for patients and caregivers. As a result, practitioners often withdraw the drug, potentially depriving patients of a beneficial clinical outcome. These reactions do not necessarily require any alteration in HER1/EGFR-inhibitor treatment and often are best addressed through symptomatic treatment. Although the evidence for using such therapies is limited, an interdisciplinary HER1/EGFR-inhibitor dermatologic toxicity forum was held in October 2006 to discuss the underlying mechanisms of these toxicities and evaluate commonly used therapeutic interventions. The result was a proposal for a simple, three-tiered grading system for skin toxicities related to HER1/EGFR inhibitors to be used in therapeutic decision making and as a framework for building a stepwise approach to intervention.

Putting evidence into practice: evidence-based interventions for cancer-related dyspnea.

Despite the common occurrence of cancer-related dyspnea, a paucity of literature is available for review, especially research literature that reports interventions to control dyspnea. The Oncology Nursing Society's Putting Evidence Into Practice (PEP) initiative organized a team on nurses to examine the literature, rank the evidence, summarize the findings, and make recommendations for nursing practice to improve patient outcomes. Pharmacologic and nonpharmacologic agents have been used to treat dyspnea. Patients who received parenteral or oral immediate-release opioids demonstrated a benefit in the reduction of breathlessness; thus, parenteral or oral opioids are recommended for practice. Five interventions are listed in the effectiveness not established category and include extended-release morphine, midazolam plus morphine, nebulized opioids, the use of gas mixtures, and cognitive-behavioral therapy. This article critically examines the evidence, provides nurses with the best evidence for practice, and identifies gaps in the literature and opportunities for further research.

Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy.

PURPOSE: In cancer treatment trials, clinicians traditionally report patient toxicity symptoms. Alternatively, patients could provide this information directly. PATIENTS AND METHODS: The Common Terminology Criteria for Adverse Events (CTCAE) is the mandated instrument for tracking patient toxicity symptoms in National Cancer Institute (NCI)-sponsored cancer treatment trials. We adapted CTCAE symptom items into patient language and uploaded these to an online platform. Lung cancer outpatients receiving chemotherapy were invited to self-report selected symptoms at visits via waiting area computers or optional home access. Symptom reports were printed for nurses at visits, but no instructions were given with regard to use of this information. RESULTS: From June 2005 through March 2006, 125 patients were invited to participate, and 107 chose to enroll. Mean length of participation was 42 weeks (range, 1 to 71 weeks), by which time 35% died. The average number of clinic visits was 12 (range, 1 to 40 visits). At each consecutive visit, most patients (mean, 78%) logged in without significant attrition. Reasons for failure to log in included having no reminder and having inadequate time. Although 76% of enrollees had home computers, only 15% self-reported from home. Satisfaction with the system was high (90%), but only 51% felt communication was improved. All participating nurses understood the reports and felt this information was useful for clinical decisions, documentation, and discussions. However, only one of seven nurses discussed reports with patients frequently, with insufficient time being the most common barrier to discussions. CONCLUSION: Online patient self-reporting is a feasible long-term strategy for toxicity symptom monitoring during chemotherapy, even among patients with advanced cancer and high symptom burdens. However, without explicit reminders and clinician feedback, patients demonstrated limited voluntary interest in self-reporting between visits.

Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study.

BACKGROUND: The Common Terminology Criteria for Adverse Events (CTCAE) are used as standard practice in trials of cancer treatments by clinicians to elicit and report toxic effects. Alternatively, patients could report this information directly as patient-reported outcomes, but the accuracy of these reports compared with clinician reports remains unclear. We aimed to compare the reporting of symptom severity reported by patients and clinicians. METHODS: Between March and May, 2005, a questionnaire with 11 common CTCAE symptoms was given to consecutive outpatients and their clinicians (physicians and nurses) in lung and genitourinary cancer clinics in the Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Patients completed a version that used language adapted from the CTCAE for patient self-reporting. The results from the questionnaire were compared with clinician reporting of the same symptoms. FINDINGS: Of 435 patients and their clinicians asked to take part in the study, 400 paired surveys were completed. For most symptoms, agreement between patient and clinician was high, and most discrepancies were within a grade difference of one point. Agreement was higher for symptoms that could be observable directly, such as vomiting and diarrhoea, than for more subjective symptoms, such as fatigue and dyspnoea. Differences in symptom reporting rarely would have changed treatment decisions or dosing, and patients assigned greater severity to symptoms more than did clinicians. No significant differences were recorded between the results when the questionnaire was completed by the patient before or after the clinician. INTERPRETATION: Patient reporting of symptoms could add to the current approach to symptom monitoring in cancer treatment trials. Future research should assess the effect of self reporting on clinical outcomes and efficiency, and the use of real-time collection of patient-reported outcomes for early detection of potentially serious adverse events.