The calories trial: Statistical analysis plan

Critical Care and Resuscitation

Volumn 16, Issue 4, 2014, Pages 248-254

  Harvey, Sheila E ^a   Parrott, Francesca ^a   Harrison, David A ^a   Mythen, Michael ^b   Rowan, Kathryn M ^a  

^a King's College London   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CONTROLLED STUDY; COST BENEFIT ANALYSIS; CRITICAL ILLNESS; ECONOMICS; ENTERIC FEEDING; HUMAN; INTENTION TO TREAT ANALYSIS; PARENTERAL NUTRITION; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

COST-BENEFIT ANALYSIS; CRITICAL ILLNESS; ENTERAL NUTRITION; HUMANS; INTENTION TO TREAT ANALYSIS; PARENTERAL NUTRITION; TREATMENT OUTCOME;

EID: 84922332524     PISSN: 14412772     EISSN: 26529335     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. 1 McClave SA, Martindale RG, Vanek VW, et al; ASPEN Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient; Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (ASPEN). JPEN J Parenter Enteral Nutr 2009; 33: 277-316.
2. 2 De Jonghe B, Appere-De-Vechi C, Fournier M, et al. A prospective survey of nutritional support practices in intensive care unit patients: what is prescribed? What is delivered? Crit Care Med 2001; 29: 8-12.
3. 3 Engel JM, Muhling J, Junger A, et al. Enteral nutrition practice in a surgical intensive care unit: what proportion of energy expenditure is delivered enterally? Clin Nutr 2003; 22: 187-92.
4. 4 Gramlich L, Kichian K, Pinilla J, et al. Does enteral nutrition compared to parenteral nutrition result in better outcomes in critically ill adult patients? A systematic review of the literature. Nutrition 2004; 20: 843-8.
5. 5 Heyland DK, Dhaliwal R, Drover JW, et al. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. JPEN J Parenter Enteral Nutr 2003; 27: 355-73.
6. 6 Simpson F, Doig GS. Parenteral vs. enteral nutrition in the critically ill patient: a meta-analysis of trials using the intention to treat principle. Intensive Care Med 2005; 31: 12-23.
7. 7 Boitano M, Bojak S, McCloskey S, et al. Improving the safety and effectiveness of parenteral nutrition: results of a quality improvement collaboration. Nutr Clin Pract 2010; 25: 663-71.
8. 8 Naylor CJ, Griffiths RD, Fernandez RS. Does a multidisciplinary total parenteral nutrition team improve patient outcomes? A systematic review. JPEN J Parenter Enteral Nutr 2004; 28: 251-8.
9. 9 Gales BJ, Gales MJ. Nutritional support teams: a review of comparative trials. Ann Pharmacother 1994; 28: 227-35.
10. 10 Harrison DA, Brady AR, Rowan K. Case mix, outcome and length of stay for admissions to adult, general critical care units in England, Wales and Northern Ireland: the Intensive Care National Audit & Research Centre Case Mix Programme Database. Crit Care 2004; 8: R99-111.
11. 11 United Kingdom Department of Health. Saving lives: reducing infection, delivering clean and safe care. High impact intervention no 1: central venous catheter care bundle. London: Department of Health, 2007. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/ groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_ 078120.pdf (accessed Jul 2014).
12. 12 National Collaborating Centre for Acute Care. Nutrition support for adults oral nutritional support, enteral tube feeding and parenteral nutrition. Methods, Evidence and Guidance. London: National Collaborating Centre for Acute Care, 2006. http://www.nice.org.uk/guidance/CG32 (accessed Aug 2014).
13. 13 National Patient Safety Agency. Reducing the harm caused by misplaced nasogastric feeding tubes. Patient safety alert. London: NPSA, 2005.
14. 14 National Patient Safety Agency. How to confirm the correct position of nasogastric feeding tubes in infants, children and adults. London: NPSA, 2005. http://www.npsa.nhs.uk/EasySiteWeb/GatewayLink. aspx?alId=3399 (accessed Jul 2014).
15. 15 National Cancer Institute. Common terminology criteria for adverse events. Version 4. Bethesda, Md: NCI, 2009. http://evs.nci.nih.gov/ ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference:5x7.pdf (accessed Mar 2014).
16. 16 Harvey S, Harrison DA, Singer M, et al. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet 2005; 366: 472-7.
17. 17 Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008; 148: 295-309.
18. 18 Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985; 13: 818-29.
19. 19 Vincent JL, Moreno R, Takala J, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/ failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996; 22: 707-10.
20. 20 Harrison DA, Parry GJ, Carpenter JR, et al. A new risk prediction model for critical care: the Intensive Care National Audit & Research Centre (ICNARC) model. Crit Care Med 2007; 35: 1091-8.
21. 21 Information Standards Board for Health and Social Care. Critical care minimum data set. Standard ISB 0153. 2010. http:// www.isb.nhs.uk/library/standard/112 (accessed Mar 2014)
22. 22 Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ 2000; 320: 1197-200.
23. 23 Greenland S. An introduction to instrumental variables for epidemiologists. Int J Epidemiol 2000; 29: 722-9.
24. 24 Fischer K, Goetghebeur E, Vrijens B, White IR. A structural mean model to allow for noncompliance in a randomized trial comparing 2 active treatments. Biostatistics 2011; 12: 247-57.
25. 25 Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ 2010; 340: c332.