Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire

Abstract

Introduction Radiopharmaceuticals may cause adverse events. Knowledge about adverse events from a patient's perspective could help healthcare professionals to detect, understand, and manage adverse events more efficiently when using radiopharmaceuticals. Researchers need a validated questionnaire that can be used in patients to assess adverse events with radiopharmaceuticals. Objective The aim of this study was to develop, validate the content of, and perform initial testing of a questionnaire assessing patient-reported adverse events of radiopharmaceuticals. Methods Based on existing literature, six professionals drafted and evaluated a first version of the questionnaire. Further content validation was performed using cognitive interviews with six patients undergoing a nuclear medicine examination. After adaptations, the questionnaire was developed into a web-based questionnaire. One hundred patients undergoing nuclear examination tested this version, and the results were used to assess its acceptability and evaluate reported adverse events. Results Questions and answer options were revised in the initial questionnaire to improve clarity. In addition, some questions were removed. The final version consisted of 18 questions. In the test phase, the acceptability of the questionnaire was demonstrated (e.g. 79% of the patients who received the questionnaire completed it, and the median time to complete the questionnaire was 12 min for patients who reported an adverse event). Of the 100 patients (53% men, median age 64 years), 12 reported a total of 22 adverse events. One of these adverse events had a high causal association. Conclusion After validation and testing, the developed questionnaire to study patient-reported adverse events of radiopharmaceuticals is a suitable and valid instrument which can be used in future research.

Patient-Reported Adverse Events of Radiopharmaceuticals: A Prospective Study of 1002 Patients

“…We used the questionnaire that we had developed, validated, and tested in our previous work [ 17 ]. The questionnaire in Dutch and an English translation can be found as supplementary material in the Electronic Supplement Material (ESM).…”

“…First, we would expect possible adverse events to occur within a few days after the nuclear medicine examination. Second, longer recall periods may introduce bias due to patients forgetting information or patients bringing up information from other sequential doctor visits or examinations [ 4 , 17 ]. In the questionnaire, we collected data from the patients about several aspects of their characteristics, health status, and occurrence of adverse events at several moments, as well as additional aspects when patients reported an adverse event (Table 1 ).…”

“…The current way of collecting safety data may provide us with information on possible safety signals but cannot provide more detailed knowledge of the frequency and impact on the patient of the adverse events of radiopharmaceuticals. For this reason, we recently developed, validated, and tested a questionnaire specifically designed to assess the adverse events of radiopharmaceuticals from the perspective of the patient [ 17 ]. This validated questionnaire was used to perform a study on a large group of patients who underwent a nuclear medicine examination, focusing especially on adverse events from the perspective of the patients.…”