How to select relevant items for monitoring? Case example of a pragmatic process for mapping immune checkpoint inhibitor #SideEffects to items from existing item libraries ( #CTCAE #EORTC #FACIT )
https://jpro.springeropen.com/articles/10.1186/s41687-025-00855-8
SpringerOpenMapping immune checkpoint inhibitor side effects to item libraries for use in real-time side effect monitoring systems - Journal of Patient-Reported OutcomesBackground Monitoring for the side effects of novel therapies using patient-reported outcomes (PROs) is critical for ensuring patient safety. Existing static patient-reported outcome measures may not provide adequate coverage of novel side effects. Item libraries provide a flexible approach to monitoring for side effects using customized item lists, but the ideal process for matching side effects to items sourced from multiple item libraries is yet to be established. We sought to develop a pragmatic process for mapping side effects to items from three major item libraries using immune checkpoint inhibitor (ICI) side effects as an example. Methods Using a consumer- and clinician-driven list of 36 ICI side effects, two authors independently mapped side effects to Common Terminology Criteria for Adverse Event (CTCAE) terms, and then to three item libraries: the Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), the European Organisation for Research and Treatment of Cancer (EORTC) Item Library, and the Functional Assessment of Chronic Illness Therapy (FACIT) searchable library. The rates of inter-rater agreement were recorded. Following item collation from the item libraries, we devised criteria for selecting the optimal item for each side effect for inclusion in a future electronic PRO system based on guidance from the above groups. Results All 36 side effects mapped to at least one CTCAE term, with eight mapping to more than one term. Twenty-three side effects mapped to at least one PRO-CTCAE term, 35 side effects mapped to at least one EORTC item, and 31 side effects mapped to at least one FACIT item. The inter-rater agreement rate was 100% (PRO-CTCAE), 83% (EORTC) and 75% (FACIT). Pre-determined criteria were applied to select the optimal item for each side effect from the three item libraries, producing a final 61-item list. Conclusion Using ICI side effects as an example, we developed a pragmatic approach to creating customized item lists from three major item libraries to monitor for side effects of novel therapies in routine care. This process highlighted the challenges of using item libraries and priorities for future work to improve their usability.
![Patient-reported measurement is the idea that patient perspectives should play an evidentiary role in determining how effective a drug is taken to be, the degree to which a hospital provides good quality care or improvements in patient-clinician communication. This idea may sound prosaic, but in fact it’s nothing short of revolutionary. It says, patient views matter – not as an afterthought, and not only at the bedside, but in the nuts and bolts of creating our evidence base, and thus in health-care decision-making. But patient-reported measures present a puzzle: How can measurement, which relies on standardization, represent patient perspectives, which, if not idiosyncratic are at least various and changeable? [redacted for length, sorry!]
Melanie Hawkins, PhD, Swinburne University of Technology, Melbourne, Australia
Sebastian Rodriguez Duque, PhD Candidate, McGill University, Montreal, Quebec, Canada
Jan R. Boehnke, PhD, School of Health Sciences, University of Dundee, Dundee, United Kingdom
Alessandra Basso, PhD, London School of Economics, United Kingdom
Richard Sawatzky, PhD RN, Trinity Western University, Langley, British Columbia, Canada
Leah McClimans, PhD, University of South Carolina, Columbia, South Carolina, United States
Kevin Weinfurt, PhD, Duke University School of Medicine, Durham, North Carolina, United States
Rebecca L. Jackson, PhD, Durham University, Durham, United Kingdom](https://files.mastodon.social/media_attachments/files/113/344/966/136/588/896/original/24d8b80e1f1d7d91.png "Patient-reported measurement is the idea that patient perspectives should play an evidentiary role in determining how effective a drug is taken to be, the degree to which a hospital provides good quality care or improvements in patient-clinician communication. This idea may sound prosaic, but in fact it’s nothing short of revolutionary. It says, patient views matter – not as an afterthought, and not only at the bedside, but in the nuts and bolts of creating our evidence base, and thus in health-care decision-making. But patient-reported measures present a puzzle: How can measurement, which relies on standardization, represent patient perspectives, which, if not idiosyncratic are at least various and changeable? [redacted for length, sorry!]
Melanie Hawkins, PhD, Swinburne University of Technology, Melbourne, Australia
Sebastian Rodriguez Duque, PhD Candidate, McGill University, Montreal, Quebec, Canada
Jan R. Boehnke, PhD, School of Health Sciences, University of Dundee, Dundee, United Kingdom
Alessandra Basso, PhD, London School of Economics, United Kingdom
Richard Sawatzky, PhD RN, Trinity Western University, Langley, British Columbia, Canada
Leah McClimans, PhD, University of South Carolina, Columbia, South Carolina, United States
Kevin Weinfurt, PhD, Duke University School of Medicine, Durham, North Carolina, United States
Rebecca L. Jackson, PhD, Durham University, Durham, United Kingdom")
) and Rebecca Jackson discussed how even the often ignored response options reflect assumptions of how we want to represent what we are measuring!
![Tarmac path with a red line on it. Below the line it is stencil sprayed in white (all CAPS):
"Ab hier sinkt Deine Lebenserwartung um 6 Jahre."
[engl. "From here on your life expectancy lowers by six years."]
This is on the foot and cycle path of the massive rail bridge in Cologne, on the left you can see some fencing and below it the river Rhine, and to the right the (potentially famous?) padlocks put up by people as a memento to their relatiionships.](https://files.mastodon.social/media_attachments/files/113/295/035/682/251/242/original/4665bfbb852016e8.jpg "Tarmac path with a red line on it. Below the line it is stencil sprayed in white (all CAPS):
\"Ab hier sinkt Deine Lebenserwartung um 6 Jahre.\"
[engl. \"From here on your life expectancy lowers by six years.\"]
This is on the foot and cycle path of the massive rail bridge in Cologne, on the left you can see some fencing and below it the river Rhine, and to the right the (potentially famous?) padlocks put up by people as a memento to their relatiionships.")