Psychological outcomes following a nurse-led preventative psychological intervention for critically ill patients trial: Statistical and health economic analysis plan
- PMID: 30515237
- PMCID: PMC6259092
- DOI: 10.1177/1751143718755016
Psychological outcomes following a nurse-led preventative psychological intervention for critically ill patients trial: Statistical and health economic analysis plan
Abstract
The Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients trial is a cluster-randomised controlled trial of the clinical and cost-effectiveness of a complex nurse-led preventative psychological intervention compared with usual care in reducing patient-reported post-traumatic stress disorder symptom severity, and other reported psychological morbidities, at six months among Level 3 (intensive care) patients in adult general critical care units in England, Wales and Northern Ireland. This paper describes the proposed statistical and health economic analyses for the Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients trial. It is important to complete and publish this plan before inspecting and locking the trial data to ensure that post hoc and data-derived decisions are avoided. Trial registration: ISRCTN53448131.
Keywords: Cognitive therapy; cost–benefit analysis; critical care; post-traumatic; statistics; stress disorders.
References
-
- Ely EW, Inouye SK, Bernard GR, et al. Delirium in mechanically ventilated patients – validity and reliability of the Confusion Assessment Method for the intensive care Unit (CAM-ICU). J Am Med Assoc 2001; 286: 2703–2710. - PubMed
-
- Finfer S, Bellomo R. Why publish statistical analysis plans? Crit Care Resusc 2009; 11: 5–6. - PubMed
-
- Sessler CN, Gosnell MS, Grap MJ, et al. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med 2002; 166: 1338–1344. - PubMed
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