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Page 4 of 14 Webster et al. J Cancer Metastasis Treat 2020;6:8 I http://dx.doi.org/10.20517/2394-4722.2019.38

Figure 1. Classes of immunotherapy

Library offers targeted assessment options, enables custom form creation, and has the flexibility needed
to accommodate new content in order to stay current with the changing landscape of immunotherapy
treatment.

METHODS
A consortium of investigators across several institutions, represented by the author list, convened around a
commitment to produce a set of PRO items to assess symptoms associated with immunotherapy. Figure 1
depicts the range of immunotherapies we considered. The array of treatments covered by Figure 1 produced
a large number of candidate adverse events to capture, leading us to recognize that a modular approach to
assessment would be most practical, perhaps even necessary, for most applications.

Although our ultimate goal is to catalogue immunotherapy toxicities generally (and as depicted in Figure 1),
we began with where the most experience and interest lies, namely the adverse effects associated with
immune checkpoint modulators (ICMs; Figure 1, Column 1). We therefore expected this would be an
exercise in identifying common toxicity profiles and their associated symptoms, followed by a prioritizing
of item content. We reviewed published literature to inform an immunotherapy construct definition and
conceptual framework. We mapped identified symptom experiences and impact onto previously developed
survey items from the FACIT Measurement System, modifying existing items and drafting new items as
necessary. This process produced a working version of an irAE item library. A shorter list of the more
common and clinically relevant symptoms was developed based on iterations of symptom review and
feedback from an expert panel, and then incorporated into the library. Figure 2 depicts our development
process, representing parallel tracks of literature review and expert input.

Expert input
A convenience sample of clinicians and researchers whose expertise aligned with project goals was
identified to provide ongoing input and guidance during the ICM Primary Symptom List development.