Abstract
Background
The Functional Living Index—Emesis (FLIE), a patient-reported outcome measure, was originally developed to assess the impact of chemotherapy-induced nausea and vomiting (CINV) on patients' daily lives over the 3 days following chemotherapy. More recent studies of CINV include assessments covering the 5 days following chemotherapy in an effort to capture information during both the acute (within 24 h) and delayed (up to 5–7 days) phases of CINV.
Goals
To assess the measurement characteristics of a modified version of the FLIE with 5-day recall. Instrument reliability, validity, and missing data were assessed.
Patients and methods
Data were collected from 183 patients receiving cisplatin ≥70 mg/m2 as part of a phase IIb antiemetic trial of an NK-1 receptor antagonist (MK-0869). Patients recorded the number of vomiting episodes and nausea ratings in a 5-day daily diary.
Results
The 5-day FLIE had: (1) excellent internal consistency within FLIE Nausea and Vomiting domains (Cronbach's alpha 0.77–0.78), (2) acceptable construct validity shown by FLIE item-total correlations stronger within domains (r=0.74–0.97) than across domains (r=0.52–0.76), and (3) acceptable convergent validity as shown by moderate to strong correlations between FLIE domain scores and independent endpoints of emetic episodes, nausea ratings, and use of rescue medications. The extent of missing data was within acceptable limits with less than 2% of patients missing data.
Conclusion
The 5-day FLIE had adequate measurement characteristics for studying the impact of CINV on patients' daily lives during the period covering both the acute and delayed phases.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Aaronson NK, Ahmedzai S, Bergman B, et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376
Bernhard J, Maibach R, Thurlimann B, Sessa C, Aapro MS (2002) Patients' estimation of overall treatment burden: why not ask the obvious? J Clin Oncol 20:65–72
Borjeson S, Hursti TJ, Tishelman C, et al (2002) Treatment of nausea and emesis during cancer chemotherapy. Discrepancies between antiemetic effect and well-being. Pain Symptom Manage 24:345–358
Cella DF, Tulsky DS, Gray G, et al (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579
Clavel M, Soukop M, Greenstreet YLA (1993) Improved control of emesis and quality of life with ondansetron in breast cancer. Oncology 50:180–185
Clavel M, Bonneterre J, d'Allens H, Paillarse JM, and the French Ondansetron Study Group (1995) Oral ondansetron in the prevention of chemotherapy-induced emesis in breast cancer patients. Eur J Cancer 31A:15–19
Cronbach LJ (1951) Coefficient alpha and the internal structure of tests. Psychometrika 16:297–334
Crucitt MA, Hyman W, Grote T, et al (1996) Efficacy and tolerability of oral ondansetron versus prochlorperazine in the prevention of emesis associated with cyclophosphamide-based chemotherapy and maintenance of health-related quality of life. Clin Ther 18:508–518
de Boer-Dennert M, de Wit R, Schmitz PI, et al (1997) Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. Br J Cancer 76:1055–1061
Gralla RJ, Rittenberg C, Peralta M, et al (1996) Cisplatin and emesis: aspects of treatment and a new trial for delayed emesis using oral dexamethasone plus ondansetron beginning at 16 hours after cisplatin. Oncology 53 [Suppl 1]:86–91
Gralla RJ, Osoba D, Kris MG, et al (1999) Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. J Clin Oncol 17:2971–2994
Griffin AM, Butow PN, Coates AS, et al (1996) On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol 7:189–195
Lindley CM, Hirsch JD, O'Neill CV, et al (1992) Quality of life consequences of chemotherapy-induced emesis. Qual Life Res 1:331–340
Multinational Association of Supportive Care in Cancer (1998) Prevention of chemotherapy- and radiotherapy-induced emesis: results of Perugia Consensus Conference. Antiemetic Subcommittee of the MASCC. Ann Oncol 9:811–819
Shipper H, Clinch J, McMurray A, et al (1984) Measuring the quality of life of cancer patients: the Functional Living Index—Cancer) development and validation. J Clin Oncol 2:472–483
Stewart A, McQuade B, Cronje JDE, et al (1995) Ondansetron compared with granisetron in the prophylaxis of cyclophosphamide-induced emesis in out-patients: a multicentre, double-blind, double-dummy, randomized, parallel-group study. Oncology 52:202–210
Streiner DL (1993) A checklist for evaluating the usefulness of rating scales. Can J Psychiatry 38:140–148
Acknowledgements
This work was funded by Merck & Co., Inc.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Martin, A.R., Pearson, J.D., Cai, B. et al. Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives: a modified version of the Functional Living Index—Emesis (FLIE) with 5-day recall. Support Care Cancer 11, 522–527 (2003). https://doi.org/10.1007/s00520-003-0482-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-003-0482-4