Health‐related quality of life trajectories in critical illness: Protocol for a Monte Carlo simulation study Article Swipe
Benjamin Skov Kaas‐Hansen
,
Maj‐Brit Nørregaard Kjær
,
Morten Hylander Møller
,
Aksel Karl Georg Jensen
,
Mia Esta Larsen
,
Brian H. Cuthbertson
,
Anders Perner
,
Anders Granholm
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1111/aas.14324
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1111/aas.14324
Background Health‐related quality of life (HRQoL) is a patient‐centred outcome increasingly used as a secondary outcome in critical care research. It may cover several important dimensions of clinical status in intensive care unit (ICU) patients that arguably elude other more easily quantified outcomes such as mortality. Poor associations with harder outcomes, conflicting data on HRQoL in critically ill compared to the background population, and paradoxical effects on HRQoL and mortality complicate the current operationalisation in critical care trials. This protocol outlines a simulation study that will gauge if the areas under the HRQoL trajectories could be a viable alternative. Methods We will gauge the behaviour of the proposed HRQoL operationalisation through Monte Carlo simulations, under clinical scenarios that reflect a broad critical care population eligible for inclusion in a large pragmatic trial. We will simulate 15,360 clinical scenarios based on a full factorial design with the following seven simulation parameters: number of patients per arm, relative mortality reduction in the interventional arm, acceleration of HRQoL improvement in the interventional arm, the relative improvement in final HRQoL in the interventional arm, dampening effect of mortality on HRQoL values at discharge from the ICU, proportion of so‐called mortality benefiters in the interventional arm and mortality trajectory shape. For each clinical scenario, we will simulate 100,000 two‐arm trials with 1:1 randomisation. HRQoL will be sampled fortnightly after ICU discharge. Outcomes will include HRQoL in survivors and all patients at the end of follow‐up; mean areas under the HRQoL trajectories in both arms; and mean difference between areas under the HRQoL trajectories and single‐sampled HRQoLs at the end of follow‐up. Discussion In the outlined simulation study, we aim to assess whether the area under the HRQoL trajectory curve could be a candidate for reconciling the seemingly paradoxical effects on improved mortality and reduced HRQoL while remaining sensitive to early or accelerated improvement in patient outcomes. The resultant insights will inform subsequent methodological work on prudent collection and statistical analysis of such data from real critically ill patients.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1111/aas.14324
- OA Status
- hybrid
- References
- 37
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4386305822
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4386305822Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1111/aas.14324Digital Object Identifier
- Title
-
Health‐related quality of life trajectories in critical illness: Protocol for a Monte Carlo simulation studyWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-08-31Full publication date if available
- Authors
-
Benjamin Skov Kaas‐Hansen, Maj‐Brit Nørregaard Kjær, Morten Hylander Møller, Aksel Karl Georg Jensen, Mia Esta Larsen, Brian H. Cuthbertson, Anders Perner, Anders GranholmList of authors in order
- Landing page
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https://doi.org/10.1111/aas.14324Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://doi.org/10.1111/aas.14324Direct OA link when available
- Concepts
-
Medicine, Protocol (science), Monte Carlo method, Critical illness, Quality of life (healthcare), Intensive care medicine, Statistics, Nursing, Critically ill, Alternative medicine, Pathology, MathematicsTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
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37Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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