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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

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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.

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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

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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.

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Authors and Affiliations

  1. Outcomes Research, United BioSource Corporation, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD, 20814, USA

    Leah Kleinman, Katy Benjamin, Maria Stoeckl Mattera & Dennis A. Revicki

  2. Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA, USA

    Hema Viswanathan

  3. Wilshire Oncology Medical Group, Rancho Cucamonga, CA, USA

    Linda Bosserman

  4. Stanford Cancer Center, Stanford, CA, USA

    Douglas W. Blayney

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  1. Leah Kleinman
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  2. Katy Benjamin
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  3. Hema Viswanathan
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  4. Maria Stoeckl Mattera
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  5. Linda Bosserman
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  7. Dennis A. Revicki
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Correspondence to Dennis A. Revicki.

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Kleinman, L., Benjamin, K., Viswanathan, H. et al. 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. Qual Life Res 21, 1255–1266 (2012). https://doi.org/10.1007/s11136-011-0034-1

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