First international recommendations on the use of item libraries for patient-reported outcome measurement
31 Jan 2023
The first international recommendations on the use of item libraries for patient-reported outcome measurement in oncology were published this week in The Lancet Oncology. This important work carried out by Claire Piccinin et al.1 addresses the need for more flexible ways to capture the patient voice, while preserving the rigour of standard (static) questionnaires.
Patient-reported outcome (PRO) measures are critical for assessing the impact of disease and treatment on cancer patients’ lives. Item libraries are a type of such measures, consisting of a list of questions (“items”); the most relevant ones can then be selected for a specific trial and patient group. The resulting customised questionnaire allows for the measurement of health-related quality of life in cancer patients, including disease-related symptoms and side effects of treatment. Item libraries enable the tailoring of questions, allowing patients to describe their experiences more fully.
About the publication by Piccinin et al.
In light of the increasing use of item libraries worldwide, this project aimed to create recommendations to optimise their use in oncology trials. Co-author Claire Piccinin, EORTC Quality of Life Department (Belgium), explains that “Given the number of choices clinical trialists face regarding which item libraries to use, how to select and analyse questions, and how to combine these with other measures, there was an important need for guidance”. To do so, an international, multidisciplinary group was brought together, including key developers of item libraries along with representatives from industry, academia, health technology assessment/regulatory agencies, and patient advocacy organisations.
Andrew Bottomley, Assistant Director and Head of the EORTC Quality of Life Department (Belgium), and senior author, highlights: “This publication is a critical piece of work that will be of value to researchers when designing new clinical trials where an item library is used. Many organisations joined forces to produce these recommendations, which reflect the current thinking of a wide range of international stakeholders, and their excellent input adds immense value to the recommendations”.
The group identified nine primary research questions to guide recommendations on how to select questions from item libraries and implement these in oncology trials. These cover, for example: the methodology to follow to select items; when to prioritise single items over multi-item scales; how to minimise bias in the design of item lists; recommendations on how to order the questions; how to identify and minimise patient burden; recommendations on the use of item lists in conjunction with traditional (static) measures and/or other measurement systems.
Co-author Daniel O’Connor, Medicines and Healthcare products Regulatory Agency (UK), commented that: “These recommendations represent an important milestone that will help to capture the patient voice in drug development and regulatory approval. Regulatory authorities are increasingly interested in the use of patient-reported outcomes in their decision making, and these expert consensus-based recommendations provide further opportunity to ensure that patient experience is integrated into our processes”.
About the Quality of Life Group
The Quality of Life Group (QLG) strives to improve health-related quality of life (HRQoL) of cancer patients, through dedicated research and the use of HRQoL measures within cancer clinical trials and clinical practice. HRQoL constitutes an important aspect of cancer research and care: it gives a voice to patients, putting their experience at the forefront. The QLG is part of the European Organisation for Research and Treatment of Cancer (EORTC).
For further information, please visit the QLG website.
The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.
Caroline Hance (EORTC QLG)
1 Claire Piccinin, Ethan Basch, Vishal Bhatnagar, Melanie Calvert, Alicyn Campbell, David Cella, Charles S Cleeland, Corneel Coens, Anne-Sophie Darlington, Amylou C Dueck, Mogens Groenvold, Ralf Herold, Bellinda L King-Kallimanis, Paul G Kluetz, Dagmara Kuliś, Daniel O’Connor, Kathy Oliver, Madeline Pe, Bryce B Reeve, Jaap C Reijneveld, Xin Shelley Wang, Andrew Bottomley, Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group, The Lancet Oncology, Volume 24, Issue 2, 2023, Pages e86-e95, ISSN 1470-2045, https://doi.org/10.1016/S1470-2045(22)00654-4. (https://www.sciencedirect.com/science/article/pii/S1470204522006544)
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