Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Nov;19(4):281-286.
doi: 10.1177/1751143718755016. Epub 2018 Jan 29.

Psychological outcomes following a nurse-led preventative psychological intervention for critically ill patients trial: Statistical and health economic analysis plan

Jerome Wulff  1 , Zia Sadique  2 , Richard Grieve  2 , David Howell  3 , Paul Mouncey  1 , Dorothy Wade  3 , Kathryn M Rowan  1 , David A Harrison  1
Affiliations

Psychological outcomes following a nurse-led preventative psychological intervention for critically ill patients trial: Statistical and health economic analysis plan

Jerome Wulff et al. J Intensive Care Soc. 2018 Nov.

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.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
POPPI cluster-RCT schedule.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. 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
    1. Wade DM, Howell DC, Weinman JA, et al. Investigating risk factors for psychological morbidity three months after intensive care: a prospective cohort study. Crit Care 2012; 16: R192. - PMC - PubMed
    1. Finfer S, Bellomo R. Why publish statistical analysis plans? Crit Care Resusc 2009; 11: 5–6. - PubMed
    1. 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
    1. Wade DM, Hankins M, Smyth DA, et al. Detecting acute distress and risk of future psychological morbidity in critically ill patients: validation of the intensive care psychological assessment tool. Crit Care 2014; 18: 519. - PMC - PubMed