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Quality of Life Research

, Volume 21, Issue 7, pp 1255–1266 | Cite as

The anemia impact measure (AIM): development and content validation of a patient-reported outcome measure of anemia symptoms and symptom impacts in cancer patients receiving chemotherapy

  • Leah Kleinman
  • Katy Benjamin
  • Hema Viswanathan
  • Maria Stoeckl Mattera
  • Linda Bosserman
  • Douglas W. Blayney
  • Dennis A. Revicki
Article

Abstract

Purpose

To develop a patient-reported outcome instrument for measuring anemia symptoms and their impact in patients with chemotherapy-induced anemia (CIA).

Methods

Qualitative research was conducted using six focus groups and 24 interviews with 46 CIA patients, eight interviews in patients receiving chemotherapy with no CIA history and two interviews in patients successfully treated for CIA. Atlas.ti 5.0 was used to organize key concepts. Cognitive interviews with 16 CIA patients and assessment of relevance of each item to CIA by 10 clinicians were also conducted to evaluate content validity.

Results

Most CIA patients were white (76%) and female (83%), and the average age was 60 years. The most common cancer types were breast cancer (54%) and lung cancer (17%). Tiredness was the most prevalent symptom and rated as the most important by 83% of CIA patients; weakness, shortness of breath, lightheadedness, and dizziness were ranked next in importance. The final anemia impact measure (AIM) contains: (1) daily CIA symptom diary (9 items), and (2) impact of CIA-related tiredness (29 items covering daily living activities, social activities, cognitive function, and emotions). Cognitive interviews found that the AIM was relevant and easy to understand.

Conclusions

The AIM assesses important patient-perceived CIA symptoms and their impact and was developed using extensive patient qualitative data.

Keywords

Chemotherapy Anemia Symptom Instrument development Content validity Qualitative research 

Abbreviations

ADLs

Activities of Daily Living

AIM

Anemia Impact Measure

CIA

Chemotherapy-Induced Anemia

ePDA

Electronic Personal Digital Assistant

FACT-An

Functional Assessment of Cancer Therapy-Anemia

FACT-Fatigue

Functional Assessment of Cancer Therapy-Fatigue

FDA

Food and Drug Administration

Hb

Hemoglobin

HRQOL

Health-Related Quality of Life

IADLs

Instrumental Activities of Daily Life

MCS

Mental Component Summary Score

NIH

National Institutes of Health

PCS

Physical Component Summary Score

PDA

Personal Digital Assistant

PRO

Patient-Reported Outcomes

SD

Standard Deviation

Notes

Acknowledgments

The authors thank Mona Martin, RN, MPA, and the research group at Health Research Associates, Inc. for an independent analysis of the data and comments on an earlier draft. The authors thank both Joel Kallich at Amgen Inc. for reviews of the protocol and manuscript and Linda Runft at Amgen Inc. for editorial assistance on the manuscript. The authors also wish to extend their acknowledgment to David Henry, MD; Heinz Ludwig, MD; Barbara Piper, DNSc, RN, AOCN, FAAN, and Lee Schwartzberg, MD, who served as members of the expert panel for their extensive input during the conceptualization and implementation of the instrument development study. Panel members participated in meetings with the authors during protocol development and during the study to discuss the recording and graduation of anemia symptoms and the difficulties in discriminating anemia symptoms from symptoms due to cancer and cancer therapy.

Supplementary material

11136_2011_34_MOESM1_ESM.doc (106 kb)
Supplementary material 1 (DOC 106 kb)

References

  1. 1.
    Groopman, J. E., & Itri, L. M. (1999). Chemotherapy-induced anemia in adults: Incidence and treatment. Journal of the National Cancer Institute, 91(19), 1616–1634.PubMedCrossRefGoogle Scholar
  2. 2.
    Knight, K., Wade, S. & Balducci, L. (2004). Prevalence and outcomes of anemia in cancer: A systematic review of the literature. Am J Med, 116(Suppl 7A), 11S–26S.Google Scholar
  3. 3.
    Merli, F., Bertini, M., Luminari, S., Mozzana, R., Berte, R., Trottini, M., et al. (2004). Quality of life assessment in elderly patients with aggressive non-Hodgkin’s Lymphoma treated with anthracycline-containing regimens. Report of a prospective study by the Intergruppo Italiano Linfomi. Haematologica, 89(8), 973–978.PubMedGoogle Scholar
  4. 4.
    Pujade-Lauraine, E. & Gascon, P. (2004). The burden of anaemia in patients with cancer. Oncology, 67(Suppl 1), 1–4.Google Scholar
  5. 5.
    Bokemeyer, C. & Foubert, J. (2004). Anemia impact and management: focus on patient needs and the use of erythropoietic agents. Semin Oncol, 31(3 Suppl 8), 4–11.Google Scholar
  6. 6.
    Boccia, R., Lillie, T., Tomita, D., & Balducci, L. (2007). The effectiveness of darbepoetin alfa administered every 3 weeks on hematologic outcomes and quality of life in older patients with chemotherapy-induced anemia. Oncologist, 12(5), 584–593.PubMedCrossRefGoogle Scholar
  7. 7.
    Berndt, E., Crown, W., Kallich, J., Long, S., Song, X., & Lyman, G. H. (2005). The impact of anaemia and its treatment on employee disability and medical costs. Pharmacoeconomics, 23(2), 183–192.PubMedCrossRefGoogle Scholar
  8. 8.
    Kallich, J. D., Tchekmedyian, N. S., Damiano, A. M., Shi, J., Black, J. T. & Erder, M. H. (2002). Psychological outcomes associated with anemia-related fatigue in cancer patients. Oncology (Williston Park), 16(9 Suppl 10), 117–124.Google Scholar
  9. 9.
    Littlewood, T. J., Kallich, J. D., San Miguel, J., Hendricks, L., & Hedenus, M. (2006). Efficacy of darbepoetin alfa in alleviating fatigue and the effect of fatigue on quality of life in anemic patients with lymphoproliferative malignancies. Journal of Pain and Symptom Management, 31(4), 317–325.PubMedCrossRefGoogle Scholar
  10. 10.
    Cella, D., Kallich, J., McDermott, A., & Xu, X. (2004). The longitudinal relationship of hemoglobin, fatigue and quality of life in anemic cancer patients: results from five randomized clinical trials. Annals of Oncology, 15(6), 979–986.PubMedCrossRefGoogle Scholar
  11. 11.
    Berndt, E., Kallich, J., McDermott, A., Xu, X., Lee, H., & Glaspy, J. (2005). Reductions in anaemia and fatigue are associated with improvements in productivity in cancer patients receiving chemotherapy. Pharmacoeconomics, 23(5), 505–514.PubMedCrossRefGoogle Scholar
  12. 12.
    Lyman, G. H., Berndt, E. R., Kallich, J. D., Erder, M. H., Crown, W. H., Long, S. R., et al. (2005). The economic burden of anemia in cancer patients receiving chemotherapy. Value Health, 8(2), 149–156.PubMedCrossRefGoogle Scholar
  13. 13.
    Seidenfeld, J., Piper, M., Bohlius, J., Weingart, O., Trelle, S., Engert, A., et al. (2006). Comparative effectiveness of epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment. Comparative effectiveness review no. 3. (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Available at: http://www.effectivehealthcare.ahrq.gov/reports/final.cfm.
  14. 14.
    Bamias, A., Aravantinos, G., Kalofonos, C., Timotheadou, N., Siafaka, V., Vlahou, I., et al. (2003). Prevention of anemia in patients with solid tumors receiving platinum-based chemotherapy by recombinant human Erythropoietin (rHuEpo): A prospective, open label, randomized trial by the Hellenic Cooperative Oncology Group. Oncology, 64(2), 102–110.PubMedCrossRefGoogle Scholar
  15. 15.
    Boogaerts, M., Coiffier, B., & Kainz, C. (2003). Impact of epoetin beta on quality of life in patients with malignant disease. British Journal of Cancer, 88(7), 988–995.PubMedCrossRefGoogle Scholar
  16. 16.
    Littlewood, T. J., Bajetta, E., Nortier, J. W., Vercammen, E., & Rapoport, B. (2001). Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: Results of a randomized, double-blind, placebo-controlled trial. Journal of Clinical Oncology, 19(11), 2865–2874.PubMedGoogle Scholar
  17. 17.
    de Castro, J., Ordonez, A., Isla, D., Sanchez, A., Arrivi, A., Manzano, J. L., et al. (2007). Early intervention with epoetin beta prevents severe anaemia in patients with solid tumours receiving platinum-based chemotherapy: Results of the NeoPrevent study. Cancer Chemotherapy and Pharmacology, 59(1), 35–42.PubMedCrossRefGoogle Scholar
  18. 18.
    Gabrilove, J. L., Cleeland, C. S., Livingston, R. B., Sarokhan, B., Winer, E., & Einhorn, L. H. (2001). Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life are similar to three-times-weekly dosing. Journal of Clinical Oncology, 19(11), 2875–2882.PubMedGoogle Scholar
  19. 19.
    Glaspy, J., Vadhan-Raj, S., Patel, R., Bosserman, L., Hu, E., Lloyd, R. E., et al. (2006). Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. Journal of Clinical Oncology, 24(15), 2290–2297.PubMedCrossRefGoogle Scholar
  20. 20.
    Cella, D. (1997). The Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale: A new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol, 34(3 Suppl 2), 13–19.Google Scholar
  21. 21.
    Yellen, S. B., Cella, D. F., Webster, K., Blendowski, C., & Kaplan, E. (1997). Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. Journal of Pain and Symptom Management, 13(2), 63–74.PubMedCrossRefGoogle Scholar
  22. 22.
    Levin, T. T., Riskind, J. H., & Li, Y. (2007). Looming threat-processing style in a cancer cohort. General Hospital Psychiatry, 29(1), 32–38.PubMedCrossRefGoogle Scholar
  23. 23.
    Manser, R. L., Wright, G., Byrnes, G., Hart, D., Conron, M., Carter, R., et al. (2006). Validity of the Assessment of Quality of Life (AQoL) utility instrument in patients with operable and inoperable lung cancer. Lung Cancer, 53(2), 217–229.PubMedCrossRefGoogle Scholar
  24. 24.
    Witzig, T. E., Silberstein, P. T., Loprinzi, C. L., Sloan, J. A., Novotny, P. J., Mailliard, J. A., et al. (2005). Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. Journal of Clinical Oncology, 23(12), 2606–2617.PubMedCrossRefGoogle Scholar
  25. 25.
    Food and Drug Administration (FDA). (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74(235), 65132–65133.Google Scholar
  26. 26.
    Revicki, D. A., Osoba, D., Fairclough, D., Barofsky, I., Berzon, R., Leidy, N. K., et al. (2000). Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Quality of Life Research, 9(8), 887–900.PubMedCrossRefGoogle Scholar
  27. 27.
    Patrick, D. L., Burke, L. B., Powers, J. H., Scott, J. A., Rock, E. P., Dawisha, S., et al. (2007). Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health, 10(Suppl 2), S125–137.Google Scholar
  28. 28.
    Marquis, P., Arnould, B., Acquadro, C., & Roberts, W. M. (2006). Patient-reported outcomes and health-related quality of life in effectiveness studies: pros and cons. Drug Development Research, 67, 193–201.CrossRefGoogle Scholar
  29. 29.
    Leidy, N. K., Revicki, D. A., & Geneste, B. (1999). Recommendations for evaluating the validity of quality of life claims for labeling and promotion. Value Health, 2(2), 113–127.PubMedCrossRefGoogle Scholar
  30. 30.
    Willke, R. J., Burke, L. B., & Erickson, P. (2004). Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Controlled Clinical Trials, 25(6), 535–552.PubMedCrossRefGoogle Scholar
  31. 31.
    Kahneman, D., Krueger, A. B., Schkade, D. A., Schwarz, N., & Stone, A. A. (2004). A survey method for characterizing daily life experience: The day reconstruction method. Science, 306(5702), 1776–1780.PubMedCrossRefGoogle Scholar
  32. 32.
    Ware, J. E., Kosinski, M., & Keller, S. D. (1995). SF-12: How to score the SF-12 physical and mental health summary scales. Boston, MA: The Health Institute, New England Medical Center.Google Scholar
  33. 33.
    Gandek, B., Ware, J. E., Aaronson, N. K., Apolone, G., Bjorner, J. B., Brazier, J. E., et al. (1998). Cross-validation of item selection and scoring for the SF-12 health survey in nine countries: Results from the IQOLA project international quality of life assessment. Journal of Clinical Epidemiology, 51(11), 1171–1178.PubMedCrossRefGoogle Scholar
  34. 34.
    World Health Organization. (1993). Indicators and strategies for iron deficiency and anemia programmes (pp. 6–10). Report of the WHO/UNICEF/UNU Consultation. Geneva, Switzerland.Google Scholar
  35. 35.
    Woolf, N. (2007). Best practices: a little structure in your codes. Atlas.ti Newsletter. Available at: http://www.atlasti.com/downloads/ATLASti_Newsletter_2007_01.pdf.
  36. 36.
    Hays, R. D., & Revicki, D. A. (2005). Reliability and validity, including responsiveness. In P. Fayers & R. D. Hays (Eds.), Assessing quality of life in clinical trials. New York: Oxford University Press.Google Scholar
  37. 37.
    McColl, E. (2005). Developing questionnaires. In P. Fayers & R. Hays (Eds.), Assessing quality of life in clinical trials (pp. 9–23). New York: Oxford University Press.Google Scholar
  38. 38.
    Willis, G., Reeve, B., & Barofsky, I. (2004). The use of cognitive interviewing techniques in quality-of-life and patient-reported outcomes assessment. In J. Lipscomb, C. Gotay, & C. Synder (Eds.), Outcomes assessment in cancer: measures, methods and applications. Cambridge, UK: Cambridge University Press.Google Scholar
  39. 39.
    Cella, D., Lai, J. S., Chang, C. H., Peterman, A., & Slavin, M. (2002). Fatigue in cancer patients compared with fatigue in the general United States population. Cancer, 94(2), 528–538.PubMedCrossRefGoogle Scholar
  40. 40.
    Harper, P. & Littlewood, T. (2005). Anaemia of cancer: impact on patient fatigue and long-term outcome. Oncology, 69(Suppl 2), 2–7.Google Scholar
  41. 41.
    Brown, D. J., McMillan, D. C., & Milroy, R. (2005). The correlation between fatigue, physical function, the systemic inflammatory response, and psychological distress in patients with advanced lung cancer. Cancer, 103(2), 377–382.PubMedCrossRefGoogle Scholar
  42. 42.
    Mancuso, A., Migliorino, M., De Santis, S., Saponiero, A., & De Marinis, F. (2006). Correlation between anemia and functional/cognitive capacity in elderly lung cancer patients treated with chemotherapy. Annals of Oncology, 17(1), 146–150.PubMedCrossRefGoogle Scholar
  43. 43.
    Vogelzang, N. J., Breitbart, W., Cella, D., Curt, G. A., Groopman, J. E., Horning, S. J., et al. (1997). Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The fatigue coalition. Seminars in Hematology, 34(3 Suppl 2), 4–12.Google Scholar
  44. 44.
    Hedenus, M., Adriansson, M., San Miguel, J., Kramer, M. H., Schipperus, M. R., Juvonen, E., et al. (2003). Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: A randomized, double-blind, placebo-controlled study. British Journal Haematology, 122(3), 394–403.CrossRefGoogle Scholar
  45. 45.
    Vansteenkiste, J., Pirker, R., Massuti, B., Barata, F., Font, A., Fiegl, M., et al. (2002). Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. Journal of the National Cancer Institute, 94(16), 1211–1220.PubMedCrossRefGoogle Scholar
  46. 46.
    Pirker, R., Ramlau, R. A., Schuette, W., Zatloukal, P., Ferreira, I., Lillie, T., et al. (2008). Safety and efficacy of darbepoetin alpha in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. Journal of Clinical Oncology, 26(14), 2342–2349.PubMedCrossRefGoogle Scholar
  47. 47.
    Cella, D., Lai, J. S., & Stone, A. (2010). Self-reported fatigue: One dimension or more? Lessons from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. Support Care Cancer.Google Scholar
  48. 48.
    Lai, J.-S., & Chen, W.-H. (2006). Fatigue archival analysis report prepared for: The PROMIS SCC analysis team. Available at: http://www.nihpromis.org/Data%20Analysis/FatigueArchivalAnalysisReport.doc.
  49. 49.
    Ryan, J. L., Carroll, J. K., Ryan, E. P., Mustian, K. M., Fiscella, K. & Morrow, G. R. (2007). Mechanisms of cancer-related fatigue. Oncologist, 12(Suppl 1), 22–34.Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Leah Kleinman
    • 1
  • Katy Benjamin
    • 1
  • Hema Viswanathan
    • 2
  • Maria Stoeckl Mattera
    • 1
  • Linda Bosserman
    • 3
  • Douglas W. Blayney
    • 4
  • Dennis A. Revicki
    • 1
  1. 1.Outcomes Research, United BioSource CorporationUnited BioSource CorporationBethesdaUSA
  2. 2.Amgen, Inc.Thousand OaksUSA
  3. 3.Wilshire Oncology Medical GroupRancho CucamongaUSA
  4. 4.Stanford Cancer CenterStanfordUSA

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