@cementino.bsky.social
Last week we achieved a major milestone at @eortc.bsky.social, by activating the first pan-european TwiCs (Trial within Cohorts) in oncology. This design, also known as cmRCT (cohort multiple Randomized Controlled Trial) was first brought up by Clare Relton in 2010 https://www.bmj.com/content/340/bmj.c1066.full.pdf+html
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
#HRQL #JPRO #PatientCentered #PatientReported #ePRO
Mapping immune checkpoint inhibitor side effects to item libraries for use in real-time side effect monitoring systems - Journal of Patient-Reported Outcomes
Background 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.
Using simulation studies to develop a portfolio of standard settings for computerised adaptive testing with the #EORTC CAT Core optimised for different purposes and populations
https://link.springer.com/article/10.1007/s11136-023-03576-x
#Psychometrics #HRQL
Development of standard computerised adaptive test (CAT) settings for the EORTC CAT Core - Quality of Life Research
Aims Computerised adaptive test (CAT) provides individualised patient reported outcome measurement while retaining direct comparability of scores across patients and studies. Optimal CAT measurement requires an appropriate CAT-setting, the set of criteria defining the CAT including start item, item selection criterion, and stop criterion. The European Organisation for Research and Treatment of Cancer (EORTC) CAT Core allows for assessing the 14 functional and symptom domains covered by the EORTC QLQ-C30 questionnaire. The aim was to present a general approach for selecting CAT-settings and to use this to develop a portfolio of standard settings for the EORTC CAT Core optimised for different purposes and populations. Methods Using simulations, the measurement properties of CATs of different length and precision were evaluated and compared allowing for identifying the most suitable settings. All CATs were initiated with the most informative QLQ-C30 item. For each domain two fixed-length and two fixed-precision standard CATs were selected focusing on efficiency (brief version) and precision (long), respectively. Results The brief fixed-length CATs included 3–5 items each while the long versions included 5–8 items. The fixed-precision CATs aimed for reliability of 0.65–0.95 (brief versions) and 0.85–0.98 (long versions), respectively. Median sample size savings using the CATs compared to the QLQ-C30 scales ranged 20%-31%, although savings varied considerably across the domains. Conclusion The EORTC CAT Core standard settings simplify selection of relevant and appropriate CATs. The CATs prioritise either brevity and efficiency or precision, but all provide increased measurement precision and hence, reduced sample size requirements compared to the QLQ-C30 scales. The CATs may be used as they are or modified to accommodate specific requirements.
Danish #ValueSet for the #EORTC QLU-C10D based on a quota sample from an online panel (n=1001):
https://link.springer.com/article/10.1007/s11136-023-03569-w
The analyses suggest that the domains with the largest utility decrements are physical functioning, pain, and role functioning.
#HealthEconomics #HRQL
Danish value sets for the EORTC QLU-C10D utility instrument - Quality of Life Research
Purpose In this study, we developed Danish utility weights for the European Organisation for Research and Treatment of Cancer (EORTC) QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30. Methods Following a standardized methodology, 1001 adult participants from the Danish general population were quota-sampled and completed a cross-sectional web-based survey and discrete choice experiment (DCE). In the DCE, participants considered 16 choice sets constructed from the key 10 dimensions of the QLU-C10D and chose their preferred health state for each one. Utility weights were calculated using conditional logistic regression with correction for non-monotonicity. Results The sample (n = 1001) was representative of the Danish general population with regard to age and gender. The domains with the largest utility decrements, i.e., the domains with the biggest impact on health utility, were physical functioning (− 0.224), pain (− 0.160), and role functioning (− 0.136). The smallest utility decrements were observed for the domains lack of appetite (− 0.024), sleep disorders (− 0.057), and fatigue (− 0.064). Non-monotonicity of severity levels was observed for the domains sleep disturbances, lack of appetite, and bowel problems. Deviations from monotonicity were not statistically significant. Conclusion The EORTC QLU-C10D is a relatively new multi-attribute utility instrument and is a promising cancer-specific health technology assessment candidate measure. The country-specific Danish utility weights from this study can be used for cost-utility analyses in Danish patients and for comparison with other country-specific utility data.
Quality of Life Research | Volume 32, issue 7
Volume 32, issue 7 articles listing for Quality of Life Research
cementino
Jan R. Boehnke