Delta inflation: A bias in the design of randomized controlled trials in critical care medicine

Critical Care

Volumn 14, Issue 2, 2010, Pages

  Aberegg, Scott K ^a   Richards, D Roxanne ^b   O'Brien, James M ^c  

^a Jordan Valley Medical Center   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONTROLLED STUDY; CRITICAL ILLNESS; CRITICALLY ILL PATIENT; DELTA INFLATION; EFFECT SIZE; FOLLOW UP; HUMAN; INTENSIVE CARE; MORTALITY; PREVALENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STATISTICAL ANALYSIS; SYSTEMATIC ERROR; BIOASSAY; EPIDEMIOLOGY; LITERATURE; METHODOLOGY;

BIAS (EPIDEMIOLOGY); CRITICAL CARE; ENDPOINT DETERMINATION; HUMANS; MORTALITY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; REVIEW LITERATURE AS TOPIC;

EID: 77951520818     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc8990     Document Type: Article

References (44)

1. Ospina-Tascon GA, Buchele GL, Vincent JL. Multicenter, randomized, controlled trials evaluating mortality in intensive care: doomed to fail?. Crit Care Med 2008, 36:1311-1322. 10.1097/CCM.0b013e318168ea3e, 18379260.
2. Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med 2001, 345:1359-1367. 10.1056/NEJMoa011300, 11794168.
3. Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med 2006, 354:449-461. 10.1056/NEJMoa052521, 16452557.
4. The NICE-SUGAR Study Investigators Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009, 360:1283-1297. 10.1056/NEJMoa0810625, 19318384, The NICE-SUGAR Study Investigators.
5. Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002, 288:862-871. 10.1001/jama.288.7.862, 12186604.
6. Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J, . CORTICUS Study Group Hydrocortisone therapy for patients with septic shock. N Engl J Med 2008, 358:111-124. 10.1056/NEJMoa071366, 18184957, CORTICUS Study Group.
7. Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K, . German Competence Network Sepsis (SepNet) Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008, 358(2):125-139. 10.1056/NEJMoa070716, 18184958, German Competence Network Sepsis (SepNet).
8. Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ 2009, 338:b1732. 10.1136/bmj.b1732, 2680945, 19435763.
9. Moher D, Schulz KF, Altman D, . for the CONSORT Group The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001, 285:1987-1991. 10.1001/jama.285.15.1987, 11308435, for the CONSORT Group.
10. Chan KB, Man-Son-Hing M, Molnar FJ, Laupacis A. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ 2001, 165:1197-1202. 81581, 11706908.
11. Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet 2005, 365:1348-1353. 10.1016/S0140-6736(05)61034-3, 15823387.
12. Matthews JN. Small clinical trials: are they all bad?. Stat Med 1995, 14:115-126. 10.1002/sim.4780140204, 7754260.
13. Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med 1994, 121:200-206.
14. Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med 2008, 5:e4. 10.1371/journal.pmed.0050004, 2174963,2174963, 18177203.
15. Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K, . PAC-Man study collaboration Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet 2005, 366:472-477. 10.1016/S0140-6736(05)67061-4, 16084255, PAC-Man study collaboration.
16. The National Heart LaBIARDSACTN Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med 2006, 354:1671-1684. 10.1056/NEJMoa051693, 16625008, The National Heart LaBIARDSACTN.
17. Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, Rodriguez AL, Beale R, Svoboda P, Laterre PF, Simon S, Light B, Spapen H, Stone J, Seibert A, Peckelsen C, De Deyne C, Postier R, Pettilä V, Artigas A, Percell SR, Shu V, Zwingelstein C, Tobias J, Poole L, Stolzenbach JC, Creasey AA, . OPTIMIST Trial Study Group Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA 2003, 290:238-247. 10.1001/jama.290.2.238, 12851279, OPTIMIST Trial Study Group.
18. Finfer S, Bellomo R, Boyce N, French J, Myburgh J, Norton R, . SAFE Study Investigators A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004, 350:2247-2256. 10.1056/NEJMoa040232, 15163774, SAFE Study Investigators.
19. Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ, . Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001, 344:699-709. 10.1056/NEJM200103083441001, 11236773, Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group.
20. Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M, . Early Goal-Directed Therapy Collaborative Group Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001, 345:1368-1377. 10.1056/NEJMoa010307, 11794169, Early Goal-Directed Therapy Collaborative Group.
21. Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía C, Nightingale P, Arroliga AC, Tobin MJ, . Mechanical Ventilation International Study Group Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA 2002, 287:345-355. 10.1001/jama.287.3.345, 11790214, Mechanical Ventilation International Study Group.
22. Sloan EP, Koenigsberg M, Gens D, Cipolle M, Runge J, Mallory MN, Rodman G. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial. JAMA 1999, 282:1857-1864. 10.1001/jama.282.19.1857, 10573278.
23. Weaver CS, Leonardi-Bee J, Bath-Hextall FJ, Bath PM. Sample size calculations in acute stroke trials: a systematic review of their reporting, characteristics, and relationship with outcome. Stroke 2004, 35:1216-1224. 10.1161/01.STR.0000125010.70652.93, 15031455.
24. Raju TN, Langenberg P, Sen A, Aldana O. How much 'better' is good enough? The magnitude of treatment effect in clinical trials. Am J Dis Child 1992, 146:407-411.
25. Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994, 272:122-124. 10.1001/jama.272.2.122, 8015121.
26. Chan AW, Hrobjartsson A, Jorgensen KJ, Gotzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 2008, 337:a2299. 10.1136/bmj.a2299, 2600604, 19056791.
27. Chalmers I, Matthews R. What are the implications of optimism bias in clinical research?. Lancet 2006, 367:449-450. 10.1016/S0140-6736(06)68153-1, 16473106.
28. Aberegg SK, O'Brien J, Khoury P, Patel R, Arkes HR. The influence of treatment effect size on willingness to adopt a therapy. Med Decis Making 2009, 29:599-605. 10.1177/0272989X09336078, 19498080.
29. Gould ALL. Planning and revising the sample size for a trial. Stat Med 1995, 14:1039-1051. 10.1002/sim.4780140922, 7569499.
30. Naylor CD, Llewellyn-Thomas HA. Can there be a more patient-centred approach to determining clinically important effect sizes for randomized treatment trials?. J Clin Epidemiol 1994, 47:787-795. 10.1016/0895-4356(94)90176-7, 7722592.
31. Chan KB, Man-Son-Hing M, Molnar FJ, Laupacis A. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ 2001, 165:1197-1202. 81581, 11706908.
32. Decullier E, Chan AW, Chapuis F. Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS Med 2009, 6:e1000034. 10.1371/journal.pmed.1000034, 2642878,2642878, 19226185.
33. Bedard PL, Krzyzanowska MK, Pintilie M, Tannock IF. Statistical power of negative randomized controlled trials presented at American Society for Clinical Oncology annual meetings. J Clin Oncol 2007, 25:3482-3487. 10.1200/JCO.2007.11.3670, 17687153.
34. Hebert RS, Wright SM, Dittus RS, Elasy TA. Prominent medical journals often provide insufficient information to assess the validity of studies with negative results. J Negat Results Biomed 2002, 1:1. 10.1186/1477-5751-1-1, 131026, 12437785.
35. Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF, Hite RD, Harabin AL. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network Comparison of two fluid-management strategies in acute lung injury. N Engl J Med 2006, 354:2564-2575. 10.1056/NEJMoa062200, 16714767, National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.
36. Rivers EP. Fluid-management strategies in acute lung injury -- liberal, conservative, or both?. N Engl J Med 2006, 354:2598-2600. 10.1056/NEJMe068105, 16714769.
37. Feinstein AR, Concato J. The quest for "power": contradictory hypotheses and inflated sample sizes. J Clin Epidemiol 1998, 51:537-545. 10.1016/S0895-4356(98)00029-8, 9674660.
38. Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA 2002, 288:358-362. 10.1001/jama.288.3.358, 12117401.
39. Altman DG, Bland JM. Absence of evidence is not evidence of absence. Aust Vet J 1996, 74:311. 10.1111/j.1751-0813.1996.tb13786.x, 8937675.
40. Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, . CONSORT Group Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004, 141:781-788. CONSORT Group.
41. Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty?. JAMA 2003, 289:2554-2559. 10.1001/jama.289.19.2554, 12759327.
42. Lim E, Brown A, Helmy A, Mussa S, Altman DG. Composite outcomes in cardiovascular research: a survey of randomized trials. Ann Intern Med 2008, 149:612-617.
43. Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, Alonso-Coello P, Alonso J, Worster A, Upadhye S, Jaeschke R, Schünemann HJ, Permanyer-Miralda G, Pacheco-Huergo V, Domingo-Salvany A, Wu P, Mills EJ, Guyatt GH. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007, 334:786. 10.1136/bmj.39136.682083.AE, 1852019, 17403713.
44. Dowdy DW, Eid MP, Sedrakyan A, Mendez-Tellez PA, Pronovost PJ, Herridge MS, Needham DM. Quality of life in adult survivors of critical illness: a systematic review of the literature. Intensive Care Med 2005, 31:611-620. 10.1007/s00134-005-2592-6, 15803303.