IMPOSE (IMProving Outcomes after Sepsis)-the effect of a multidisciplinary follow-up service on health-related quality of life in patients postsepsis syndromes-a double-blinded randomised controlled trial: Protocol

BMJ Open

Volumn 4, Issue 5, 2014, Pages

  Paratz, Jennifer D ^a,b,c   Kenardy, Justin ^d   Mitchell, Geoffrey ^a   Comans, Tracy ^c   Coyer, Fiona ^e   Thomas, Peter ^a,b   Singh, Sunil ^f   Luparia, Louise ^a,c   Boots, Robert J ^a,b  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^c GRIFFITH UNIVERSITY   (Australia)

^d UNIVERSITY OF QUEENSLAND   (Australia)

^e QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

^f Wide Bay Hospital and Health Service   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CONTROLLED STUDY; COST UTILITY ANALYSIS; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HEALTH CARE COST; HEALTH CARE UTILIZATION; HOSPITAL READMISSION; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; OUTPATIENT DEPARTMENT; POST SEPSIS SYNDROME; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCREENING; SEPSIS; SHORT FORM 36; AFTERCARE; METHODOLOGY; PATIENT CARE; SYNDROME;

AFTERCARE; DOUBLE-BLIND METHOD; FOLLOW-UP STUDIES; HUMANS; PATIENT CARE TEAM; QUALITY OF LIFE; RESEARCH DESIGN; SEPSIS; SYNDROME;

EID: 84901411458     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2014-004966     Document Type: Article

References (48)

1. Oeyen SG, Vandijck DM, Benoit DB, et al. Quality of life after intensive care: a systematic review of the literature. Crit Care Med 2010;38:2386-400.
2. Myhren H, Ekeberg O, Stokland O. Health related quality of life and return to work after critical illness in general intensive care unit patients: a 1-year follow up study. Crit Care Med 2010;38:1554-61.
3. Williams TA, Dobb GJ, Finn JC, et al. Long term survival from intensive care: a review. Intensive Care Med 2005;31:1306-15. (Pubitemid 41437724)
4. Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med 2011;39:371-9.
5. Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care 2013;17:R101. http://ccforum.com.contnet/17/3/R101
6. Griffiths J, Hatch RA, Bishop J, et al. An exploration of social and economic outcome and health related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care 2013;17:R100. http://ccforum.com/content/17/3/R100
7. Needham DM, Feldman DR, Kho ME. The functional costs of ICU survivorship. Collaborating to improve post-ICU disability. Am J Respir Crit Care Med 2011;183:1037-42.
8. Rehabilitation after critical illness. NHS National Institute for Health and Clinical Excellence 2009. http://www.guidance.nice.org.uk/cg83
9. Hofhuis JGM, Spronk PE, van Stel HF, et al. The impact of severe sepsis on health related quality of life: a long term follow up study. Crit Care Trauma 2008;107:1957-64.
10. Levy MM, Fink MP, Marshall JC, et al. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med 2003;29:530-8. (Pubitemid 36523666)
11. Angus DC, Lind-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States analysis of incidence outcome, and associated costs. Crit Care Med 2001;29:1303-10. (Pubitemid 32641789)
12. Silva E, Araujo DV. Economic and social burden of sepsis. In: Yearbook of Intensive Care and Emergency Medicine. Vincent J-L, Eds. Berlin: Springer-Verlag, 2009:129-38.
13. Karlsson S, Ruokonen E, Varpula T, et al. Long-term outcome and quality adjusted life years after severe sepsis. Crit Care Med 2009;37:1268-74.
14. Zhang K, Mao X, Fang Q, et al. Impaired long-term quality of life in survivors of severe sepsis Chinese multicenter study over 6 years. Anaesthesist 2013;62:995-1002.
15. Cuthbertson BH, Elder A, Hall S, et al. Mortality and quality of life in the five years after severe sepsis. Crit Care 2013;17:R70. http://ccforum.com/ content/17/2/R70
16. Winters BD, Eberlein M, Leung J, et al. Long-term mortality and quality of life in sepsis: a systematic review. Crit Care Med 2010;38:1276-83.
17. Paratz JD, Kayambu G. Early exercise and attenuation of myopathy in the patient with sepsis in ICU. Phys Ther Rev 2011;16:58-65.
18. Baldwin CE, Bersten AD. Alterations in respiratory and limb muscle strength and size in patients with sepsis who are mechanically ventilated. Phys Ther 2014;94:68-82.
19. Zimmer A, Rothaug J, Mescha S, et al. Chronic pain after surviving sepsis. Crit Care 2006;10(Suppl 1):421.
20. Iwashyna TJ, Ely EW, Smith DM, et al. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA 2010;304:1787-94.
21. Griffiths JA, Barber VS, Cuthbertson BH, et al. A national survey of intensive care follow-up clinics. Anaesthesia 2006;61:950-5. (Pubitemid 44377455)
22. Bambi S, Solaro M, Cianchi G, et al. Outpatient intensive care unit follow-up services in Italy: a national survey: a brief report. Dimens Crit Care Nurs 2013;32:46-9.
23. Williams TA, Leslie GD. Beyond the walls: a review of ICU clinics and their impact on patient outcomes after leaving hospital. Aust Crit Care 2008;21:6-17.
24. Cuthbertson BH, Rattray J, Campbell MK, et al. The PRaCTICal study of nurse led, intensive care follow up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009;339:b3723.
25. Williams TA, Leslie GD. Challenges and possible solutions for long-term follow-up of patients surviving critical illness. Aust Crit Care 2011;24:175-85.
26. Boots RJ, Singh S, Terblanche M, et al. Remote care by telemedicine in the ICU: many models of care can be effective. Curr Opin Crit Care 2011;17:634-40.
27. Moher D, Schulz K, Altman D. The CONSORT statement: revised recommendations for improving the quality of parallel-group randomized controlled trials. Ann Internal Med 2001;134:657-62. (Pubitemid 32322244)
28. Chan AW, Teztlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:37586.
29. Waldman E, Potter JF. A prospective evaluation of the Cumulative Illness Rating Scale. Aging 1992;4:171-8.
30. Baldwin CE, Paratz JD, Bersten AD. Muscle strength assessment in critically ill patients with handheld dynamometry: an investigation of reliability, minimal detectable change, and time to peak force generation. J Crit Care 2012;28:77-86.
31. Lennon S, Johnson L. The modified Rivermead Mobility Index: validity and reliability. Disabil Rehabil 2000;22:833-9. (Pubitemid 32014165)
32. Thorbahn LD, Newton RA. Use of the Berg Balance test to predict falls in elderly persons. Phys Ther 1996;76:576-85. (Pubitemid 26181497)
33. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist 1980;20:649-55. (Pubitemid 11170845)
34. Cleeland CS. Measurement of pain by subjective report. In: Chapman CRLoeser JD, eds. Advances in pain research and therapy, volume 12: issues in pain measurement. New York: Raven Press, 1989:391-403.
35. Conybeare D, Behar E, Solomon A, et al. The PTSD Checklist-Civilian Version: reliability, validity, and factor structure in a nonclinical sample. J Clin Psychol 2012;68:699-713.
36. Spitzer RL, Kroenke K, Williams JBW, et al. A brief measure for assessing generalized anxiety disorder. Arch Intern Med 2006;166:1092-7. (Pubitemid 43765180)
37. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9 validity of a brief depression severity measure. J Gen Intern Med 2001;16:606-13. (Pubitemid 32823891)
38. Ware JD, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
39. Contopoulos-Ioannidis DG, Karvouni A, Kouri I, et al. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ 2009;338:a3006.
40. Heyland DK, Hopman W, Coo H, et al. Long-term health-related quality of life in survivors of sepsis. Short Form 36: a valid and reliable measure of health-related quality of life. Crit Care Med 2000;28:3599-605.
41. Kayambu G, Boots R, Paratz J. A prospective randomised controlled trial investigating functional and physiological outcomes following early rehabilitation in sepsis: the i-PERFORM Trial - protocol article. BMC Anesthesiol 2011;11:21.
42. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21:271-92. (Pubitemid 34143147)
43. Reilly MC, Zbrozek AS, Dukes E. The validity and reproducibility of a work productivity and activity impairment measure. Pharmacoeconomics 1993;4:353-65.
44. Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale, NJ: Erlbaum, 1988.
45. Knaus WA, Draper EA, Wagner DP, et al. APACHE II: a severity of disease classification system. Crit Care Med 1985;13:818-29. (Pubitemid 15250137)
46. Twisk J, de Vente W. Attrition in longitudinal studies. How to deal with missing data. J Clin Epidemiol 2002;55:329-37. (Pubitemid 34240484)
47. Schoenfeld D. Sample-size formula for the proportional-hazards regression model. Biometrics 1983;39:499-503. (Pubitemid 14267522)
48. Drummond M, O'Brien B, Stoddart G, et al. Methods for the economic evaluation of health care programmes. New York: Oxford Medical Publications, 1993.