Do the observational studies using propensity score analysis agree with randomized controlled trials in the area of sepsis?

Journal of Critical Care

Volumn 29, Issue 5, 2014, Pages 886.e9-886.e15

  Zhang, Zhongheng ^a   Ni, Hongying ^a   Xu, Xiao ^a  

^a ZHEJIANG UNIVERSITY   (China)

Author keywords

Propensity score; Randomized controlled trial; Sepsis

Indexed keywords

ANTIBIOTIC AGENT; ANTITHROMBIN III; DROTRECOGIN; ETOMIDATE; FISH OIL; RECOMBINANT THROMBOMODULIN; STEROID; ACTIVATED PROTEIN C; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; THROMBOMODULIN;

ANTIBIOTIC THERAPY; ARTICLE; CLINICAL EFFECTIVENESS; EFFECT SIZE; HUMAN; INTUBATION; LOW DRUG DOSE; META ANALYSIS; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PROPENSITY SCORE; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; SEPSIS; SUPPLEMENTATION; SYSTEMATIC REVIEW; INTENSIVE CARE UNIT; METHODOLOGY; MONITORING; MORBIDITY; MORTALITY; PUBLICATION; SENSITIVITY ANALYSIS; SEPTICEMIA; COMPARATIVE STUDY; COMPLICATION; SHOCK, SEPTIC; STATISTICAL ANALYSIS; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

HUMANS; MATCHED-PAIR ANALYSIS; OBSERVATIONAL STUDY AS TOPIC; PROPENSITY SCORE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEPSIS; SHOCK, SEPTIC; TREATMENT OUTCOME;

EID: 84906056240     PISSN: 08839441     EISSN: 15578615     Source Type: Journal    
DOI: 10.1016/j.jcrc.2014.05.023     Document Type: Article

References (46)

1. Linde-Zwirble W.T., Angus D.C. Severe sepsis epidemiology: sampling, selection, and society. Crit Care 2004, 8(4):222-226.
2. Cheng B., Xie G., Yao S., Wu X., Guo Q., Gu M., et al. Epidemiology of severe sepsis in critically ill surgical patients in ten university hospitals in China. Crit Care Med 2007, 35(11):2538-2546.
3. Dombrovskiy V.Y., Martin A.A., Sunderram J., Paz H.L. Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med 2007, 35(5):1244-1250.
4. Dellinger R.P., Levy M.M., Rhodes A., Annane D., Gerlach H., Opal S.M., et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med 2013, 39(2):165-228.
5. Albert R.K. "Lies, damned lies . . ." and observational studies in comparative effectiveness research. Am J Respir Crit Care Med 2013, 187(11):1173-1177.
6. Marko N.F., Weil R.J. The role of observational investigations in comparative effectiveness research. Value Health 2010, 13(8):989-997.
7. Biondi-Zoccai G., Romagnoli E., Agostoni P., Capodanno D., Castagno D., D'Ascenzo F., et al. Are propensity scores really superior to standard multivariable analysis?. Contemp Clin Trials 2011, 32(5):731-740.
8. Gayat E., Pirracchio R., Resche-Rigon M., Mebazaa A., Mary J.Y., Porcher R. Propensity scores in intensive care and anaesthesiology literature: a systematic review. Intensive Care Med 2010, 36(12):1993-2003.
9. Rice M.J. Evidence-based practice: a model for clinical application. J Am Psychiatr Nurses Assoc 2013, 19(4):217-221.
10. DerSimonian R., Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986, 7(3):177-188.
11. Sterne J.A., Sutton A.J., Ioannidis J.P., Terrin N., Jones D.R., Lau J., et al. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ 2011, 343:d4002.
12. Egger M., Davey Smith G., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997, 315(7109):629-634.
13. Begg C.B., Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994, 50(4):1088-1101.
14. Laterre P.-F., Nelson D.R., Macias W., Abraham E., Sashegyi A., Williams M.D., et al. International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: 28-day survival and safety. J Crit Care 2007, 22(2):142-152.
15. Dhainaut J.-F., Payet S., Vallet B., França L.R., Annane D., Bollaert P.-E., et al. Cost-effectiveness of activated protein C in real-life clinical practice. Crit Care 2007, 11(5):R99.
16. Lindenauer P.K., Rothberg M.B., Nathanson B.H., Pekow P.S., Steingrub J.S. Activated protein C and hospital mortality in septic shock: a propensity-matched analysis. Crit Care Med 2010, 38(4):1101-1107.
17. Sadaka F., O'Brien J., Migneron M., Stortz J., Vanston A., Taylor R.W. Activated protein C in septic shock: a propensity-matched analysis. Crit Care 2011, 15(2):R89.
18. Rimmer E., Kumar A., Doucette S., Marshall J., Dial S., Gurka D., et al. Activated protein C and septic shock: a propensity-matched cohort study. Crit Care Med 2012, 40(11):2974-2981.
19. Ferrer R., Artigas A., Suarez D., Palencia E., Levy M.M., Arenzana A., et al. Effectiveness of treatments for severe sepsis: a prospective, multicenter, observational study. Am J Respir Crit Care Med 2009, 180(9):861-866.
20. Raurich J.M., Llompart-Pou J.A., Ibáñez J., Frontera G., Pérez O., García L., et al. Low-dose steroid therapy does not affect hemodynamic response in septic shock patients. J Crit Care 2007, 22(4):324-329.
21. Beale R., Janes J.M., Brunkhorst F.M., Dobb G., Levy M.M., Martin G.S., et al. Global utilization of low-dose corticosteroids in severe sepsis and septic shock: a report from the PROGRESS registry. Crit Care 2010, 14(3):R102.
22. Moubarak P., Zilker S., Wolf H., Hofner B., Kneib T., Küchenhoff H., et al. Activity-guided antithrombin III therapy in severe surgical sepsis: efficacy and safety according to a retrospective data analysis. Shock 2008, 30(6):634-641.
23. Kumar A., Zarychanski R., Light B., Parrillo J., Maki D., Simon D., et al. Early combination antibiotic therapy yields improved survival compared with monotherapy in septic shock: a propensity-matched analysis. Crit Care Med 2010, 38(9):1773-1785.
24. Wohlmuth C., Dünser M.W., Wurzinger B., Deutinger M., Ulmer H., Torgersen C., et al. Early fish oil supplementation and organ failure in patients with septic shock from abdominal infections: a propensity-matched cohort study. JPEN J Parenter Enteral Nutr 2010, 34(4):431-437.
25. Mekontso Dessap A., Ouanes I., Rana N., Borghi B., Bazin C., Katsahian S., et al. Effects of discontinuing or continuing ongoing statin therapy in severe sepsis and septic shock: a retrospective cohort study. Crit Care 2011, 15(4):R171.
26. Jung B., Clavieras N., Nougaret S., Molinari N., Roquilly A., Cisse M., et al. Effects of etomidate on complications related to intubation and on mortality in septic shock patients treated with hydrocortisone: a propensity score analysis. Crit Care 2012, 16(6):R224.
27. Yamakawa K., Ogura H., Fujimi S., Morikawa M., Ogawa Y., Mohri T., et al. Recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis. Intensive Care Med 2013, 39(4):644-652.
28. Marti-Carvajal A.J., Sola I., Gluud C., Lathyris D., Cardona A.F. Human recombinant protein C for severe sepsis and septic shock in adult and paediatric patients. Cochrane Database Syst Rev 2012, 12:CD004388.
29. Minneci P.C., Deans K.J., Eichacker P.Q., Natanson C. The effects of steroids during sepsis depend on dose and severity of illness: an updated meta-analysis. Clin Microbiol Infect 2009, 15(4):308-318.
30. Afshari A., Wetterslev J., Brok J., Moller A.M. Antithrombin III for critically ill patients. Cochrane Database Syst Rev 2008, 3:CD005370.
31. Brunkhorst F.M., Oppert M., Marx G., Bloos F., Ludewig K., Putensen C., et al. Effect of empirical treatment with moxifloxacin and meropenem vs meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial. JAMA 2012, 307(22):2390-2399.
32. Barbosa V.M., Miles E.A., Calhau C., Lafuente E., Calder P.C. Effects of a fish oil containing lipid emulsion on plasma phospholipid fatty acids, inflammatory markers, and clinical outcomes in septic patients: a randomized, controlled clinical trial. Crit Care 2010, 14(1):R5.
33. Patel J.M., Snaith C., Thickett D.R., Linhartova L., Melody T., Hawkey P., et al. Randomized double-blind placebo-controlled trial of 40mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial). Crit Care 2012, 16(6):R231.
34. Kruger P., Bailey M., Bellomo R., Cooper D.J., Harward M., Higgins A., et al. A multicenter randomized trial of atorvastatin therapy in intensive care patients with severe sepsis. Am J Respir Crit Care Med 2013, 187(7):743-750.
35. Jabre P., Combes X., Lapostolle F., Dhaouadi M., Ricard-Hibon A., Vivien B., et al. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet 2009, 374(9686):293-300.
36. Tekwani K.L., Watts H.F., Sweis R.T., Rzechula K.H., Kulstad E.B. A comparison of the effects of etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a prospective, randomized study. Ann Emerg Med 2010, 56(5):481-489.
37. Vincent J.L., Ramesh M.K., Ernest D., LaRosa S.P., Pachl J., Aikawa N., et al. A randomized, double-blind, placebo-controlled, Phase 2b study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation. Crit Care Med 2013, 41(9):2069-2079.
38. Poole D., Bertolini G., Garattini S. Withdrawal of 'Xigris' from the market: old and new lessons. J Epidemiol Community Health 2012, 66(7):571-572.
39. Mitka M. Drug for severe sepsis is withdrawn from market, fails to reduce mortality. JAMA 2011, 306(22):2439-2440.
40. Pham T., Combes A., Roze H., Chevret S., Mercat A., Roch A., et al. Extracorporeal membrane oxygenation for pandemic influenza A(H1N1)-induced acute respiratory distress syndrome: a cohort study and propensity-matched analysis. Am J Respir Crit Care Med 2013, 187(3):276-285.
41. Rubin D.B. Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997, 127(8 Pt 2):757-763.
42. Austin P.C. Primer on statistical interpretation or methods report card on propensity-score matching in the cardiology literature from 2004 to 2006: a systematic review. Circ Cardiovasc Qual Outcomes 2008, 1(1):62-67.
43. Nallamothu B.K., Hayward R.A., Bates E.R. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation 2008, 118(12):1294-1303.
44. Dhainaut J.F., Antonelli M., Wright P., Desachy A., Reignier J., Lavoue S., et al. Extended drotrecogin alfa (activated) treatment in patients with prolonged septic shock. Intensive Care Med 2009, 35(7):1187-1195.
45. Angus D.C., Laterre P.F., Helterbrand J., Ely E.W., Ball D.E., Garg R., et al. The effect of drotrecogin alfa (activated) on long-term survival after severe sepsis. Crit Care Med 2004, 32(11):2199-2206.
46. Harbarth S., Garbino J., Pugin J., Romand J.A., Lew D., Pittet D. Inappropriate initial antimicrobial therapy and its effect on survival in a clinical trial of immunomodulating therapy for severe sepsis. Am J Med 2003, 115(7):529-535.