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Interactions in the...
Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions : a protocol for a simulation study
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- Olsen, Markus Harboe (författare)
- Copenhagen University Hospital
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- Jensen, Aksel Karl Georg (författare)
- University of Copenhagen
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- Dankiewicz, Josef (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Skrifvars, Markus B. (författare)
- Helsinki University Central Hospital
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- Reinikainen, Matti (författare)
- University of Eastern Finland
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- Tiainen, Marjaana (författare)
- Helsinki University Central Hospital
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- Saxena, Manoj (författare)
- University of New South Wales
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- Aneman, Anders (författare)
- University of New South Wales,South Western Sydney Local Health District
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- Gluud, Christian (författare)
- University of Southern Denmark,Copenhagen University Hospital
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- Ullén, Susann (författare)
- Skåne University Hospital
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- Nielsen, Niklas (författare)
- Lund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Kliniska Vetenskaper, Helsingborg,Institutionen för kliniska vetenskaper, Lund,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,SEBRA Sepsis and Bacterial Resistance Alliance,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Sciences, Helsingborg,Department of Clinical Sciences, Lund,Center for cardiac arrest,Lund University Research Groups,Helsingborg Hospital
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- Jakobsen, Janus Christian (författare)
- University of Southern Denmark,Copenhagen University Hospital
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(creator_code:org_t)
- 2022-10-22
- 2022
- Engelska.
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 23:1
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background: Randomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions have no interactions on outcomes. Here, we present a protocol for a simulation study investigating the consequences of different levels of interactions between the trial interventions on outcomes for the future 2×2×2 factorial designed randomised clinical Sedation, TEmperature, and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial in comatose patients after out-of-hospital cardiac arrest. Methods: By simulating a multisite trial with 50 sites and 3278 participants, and a presumed six-month all-cause mortality of 60% in the control population, we will investigate the validity of the trial results with different levels of interaction effects on the outcome. The primary simulation outcome of the study is the risks of type-1 and type-2 errors in the simulated scenarios, i.e. at what level of interaction is the desired alpha and beta level exceeded. When keeping the overall risk of type-1 errors ≤ 5% and the risk of type-2 errors ≤ 10%, we will quantify the maximum interaction effect we can accept if the planned sample size is increased by 5% to take into account possible interaction between the trial interventions. Secondly, we will assess how interaction effects influence the minimal detectable difference we may confirm or reject to take into account 5% (small interaction effect), 10% (moderate), or 15% (large) positive interactions in simulations with no ‘true’ intervention effect (type-1 errors) and small (5%), moderate (10%), or large negative interactions (15%) in simulations with ‘true’ intervention effects (type-2 errors). Moreover, we will investigate how much the sample size must be increased to account for a small, moderate, or large interaction effects. Discussion: This protocol for a simulation study will inform the design of a 2×2×2 factorial randomised clinical trial of how potential interactions between the assessed interventions might affect conclusions. Protocolising this simulation study is important to ensure valid and unbiased results.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Factorial design
- Interactions
- Protocol
- Randomised clinical trial
- Simulation study
- Statistical analysis plan
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Olsen, Markus Ha ...
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Jensen, Aksel Ka ...
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Dankiewicz, Jose ...
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Skrifvars, Marku ...
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Reinikainen, Mat ...
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Tiainen, Marjaan ...
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Saxena, Manoj
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Aneman, Anders
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Gluud, Christian
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Ullén, Susann
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Nielsen, Niklas
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Jakobsen, Janus ...
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