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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To develop a patient-reported outcome instrument for measuring anemia symptoms and their impact in patients with chemotherapy-induced anemia (CIA).
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.
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.
The AIM assesses important patient-perceived CIA symptoms and their impact and was developed using extensive patient qualitative data.
KeywordsChemotherapy Anemia Symptom Instrument development Content validity Qualitative research
Activities of Daily Living
Anemia Impact Measure
Electronic Personal Digital Assistant
Functional Assessment of Cancer Therapy-Anemia
Functional Assessment of Cancer Therapy-Fatigue
Food and Drug Administration
Health-Related Quality of Life
Instrumental Activities of Daily Life
Mental Component Summary Score
National Institutes of Health
Physical Component Summary Score
Personal Digital Assistant
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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