The need to reform our assessment of evidence from clinical trials: A commentary

Philosophy, Ethics, and Humanities in Medicine

Volumn 3, Issue 1, 2008, Pages

  Bagshaw, Sean M ^a   Bellomo, Rinaldo ^b,c  

^a UNIVERSITY OF ALBERTA HOSPITAL   (Canada)

^b AUSTIN HOSPITAL   (Australia)

^c MONASH UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; EVIDENCE BASED MEDICINE; HUMAN; META ANALYSIS; RANDOMIZED CONTROLLED TRIAL; STANDARD;

EVIDENCE-BASED MEDICINE; HUMANS; META-ANALYSIS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 54349089426     PISSN: None     EISSN: 17475341     Source Type: Journal    
DOI: 10.1186/1747-5341-3-23     Document Type: Article

References (63)

1. Hill AB The Environment and Disease: Association or Causation? Proc R Soc Med 1965, 58:295-300. 1898525 14283879
2. Cook DJ Guyatt GH Laupacis A Sackett DL Rules of evidence and clinical recommendations on the use of antithrombotic agents Chest 1992, 102:305S-311S. 10.1378/chest.102.4.305S 1395818
3. Cook DJ Guyatt GH Laupacis A Sackett DL Goldberg RJ Clinical recommendations using levels of evidence for antithrombotic agents Chest 1995, 108:227S-230S. 10.1378/chest.108.4_Supplement.227S 7555178
4. Guyatt GH Cook DJ Sackett DL Eckman M Pauker S Grades of recommendation for antithrombotic agents Chest 1998, 114:441S-444S. 10.1378/ chest.114.5_Supplement.441S 9822056
5. Bellomo R Ronco C Kellum JA Mehta RL Palevsky P Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: The Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group Crit Care 2004, 8:R204-212. 522841 15312219 10.1186/cc2872
6. Dellinger RP Carlet JM Masur H Gerlach H Calandra T Cohen J Gea-Banacloche J Keh D Marshall JC Parker MM Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock Crit Care Med 2004, 32:858-873. 10.1097/01.CCM.0000117317.18092.E4 15090974
7. Atkins D Best D Briss PA Eccles M Falck-Ytter Y Flottorp S Guyatt GH Harbour RT Haugh MC Henry D Grading quality of evidence and strength of recommendations Bmj 2004, 328:1490. 428525 15205295 10.1136/ bmj.328.7454.1490
8. Konstantinides S Geibel A Heusel G Heinrich F Kasper W Heparin plus alteplase compared with heparin alone in patients with submassive pulmonary embolism N Engl J Med 2002, 347:1143-1150. 10.1056/ NEJMoa021274 12374874
9. Upshur RE The ethics of alpha: Reflections on statistics, evidence and values in medicine Theor Med Bioeth 2001, 22:565-576. 10.1023/ A:1014462116530 11939426
10. Ferreira F Vincent JL Brun-Buisson C Sprung C Sibbald W Cook D Doctors' perceptions of the effects of interventions tested in prospective, randomised, controlled, clinical trials: Results of a survey of ICU physicians Intensive Care Med 2001, 27:548-554. 10.1007/s001340000749 11355124
11. Guyatt GH Meade MO Jaeschke RZ Cook DJ Haynes RB Practitioners of evidence based care. Not all clinicians need to appraise evidence from scratch but all need some skills Bmj 2000, 320:954-955. 1117895 10753130 10.1136/bmj.320.7240.954
12. Atkins D Eccles M Flottorp S Guyatt GH Henry D Hill S Liberati A O'Connell D Oxman AD Phillips B Systems for grading the quality of evidence and the strength of recommendations I: Critical appraisal of existing approaches The GRADE Working Group BMC Health Serv Res 2004, 4:38. 545647 15615589 10.1186/1472-6963-4-38
13. Upshur RE Are all evidence-based practices alike? Problems in the ranking of evidence Cmaj 2003, 169:672-673. 202284 14517125
14. Delaney A Bagshaw SM Ferland A Manns B Laupland KB Doig CJ A systematic evaluation of the quality of meta-analyses in the critical care literature Crit Care 2005, 9:R575-582. 1297628 16277721 10.1186/cc3803
15. Biondi-Zoccai GG Lotrionte M Abbate A Testa L Remigi E Burzotta F Valgimigli M Romagnoli E Crea F Agostoni P Compliance with QUOROM and quality of reporting of overlapping meta-analyses on the role of acetylcysteine in the prevention of contrast associated nephropathy: case study Bmj 2006, 332:202-209. 1352049 16415336 10.1136/ bmj.38693.516782.7C
16. LeLorier: J Gregoire G Benhaddad A Lapierre J Derderian F Discrepancies between meta-analyses and subsequent large randomized, controlled trials N Engl J Med 1997, 337:536-542. 10.1056/NEJM199708213370806 9262498
17. Young C Horton R Putting clinical trials into context Lancet 2005, 366:107-108. 10.1016/S0140-6736(05)66846-8 16005318
18. Atkins D Briss PA Eccles M Flottorp S Guyatt GH Harbour RT Hill S Jaeschke R Liberati A Magrini N Systems for grading the quality of evidence and the strength of recommendations II: Pilot study of a new system BMC Health Serv Res 2005, 5:25. 1084246 15788089 10.1186/ 1472-6963-5-25
19. Schunemann HJ Best D Vist G Oxman AD Letters, numbers, symbols and words: How to communicate grades of evidence and recommendations Cmaj 2003, 169:677-680. 202287 14517128
20. Grossman J Mackenzie FJ The randomized controlled trial: Gold standard, or merely standard? Perspect Biol Med 2005, 48:516-534. 10.1353/ pbm.2005.0092 16227664
21. Mercer SL DeVinney BJ Fine LJ Green LW Dougherty D Study designs for effectiveness and translation research: Identifying trade-offs Am J Prev Med 2007, 33:139-154. 10.1016/j.amepre.2007.04.005 17673103
22. Delaney: A Angus DC Bellomo R Cameron P Cooper DJ Finfer S Harrison DA Huang DT Myburgh JA Peake SL Bench-to-bedside review: The evaluation of complex interventions in critical care Crit Care 2008, 12:210. 2447586 18439321 10.1186/cc6576
23. Deans KJ Minneci PC Suffredini AF Danner RL Hoffman WD Ciu X Klein HG Schechter AN Banks SM Eichacker PQ Natanson C Randomization in clinical trials of titrated therapies: Unintended consequences of using fixed treatment protocols Crit Care Med 2007, 35:1509-1516. 10.1097/ 01.CCM.0000266584.40715.A6 17440420
24. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network N Engl J Med 2000, 342:1301-1308. 10.1056/NEJM200005043421801 10793162
25. Hebert PC Wells G Blajchman MA Marshall J Martin C Pagliarello G Tweeddale M Schweitzer I Yetisir E A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group N Engl J Med 1999, 340:409-417. 10.1056/NEJM199902113400601 9971864
26. 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
27. 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
28. Whitley E Ball J Statistics review 4: Sample size calculations Crit Care 2002, 6:335-341. 137461 12225610 10.1186/cc1521
29. Montori VM Devereaux PJ Adhikari NK Burns KE Eggert CH Briel M Lacchetti C Leung TW Darling E Bryant DM Randomized trials stopped early for benefit: A systematic review Jama 2005, 294:2203-2209. 10.1001/ jama.294.17.2203 16264162
30. Le Henanff A Giraudeau B Baron G Ravaud P Quality of reporting of noninferiority and equivalence randomized trials Jama 2006, 295:1147-1151. 10.1001/jama.295.10.1147 16522835
31. Wheatley K Clayton D Be skeptical about unexpected large apparent treatment effects: The case of an MRC AML12 randomization Control Clin Trials 2003, 24:66-70. 10.1016/S0197-2456(02)00273-8 12559643
32. Banting FG Best CH Collip JB Campbell WR Fletcher AA Pancreatic extracts in the treatment of diabetes mellitus: Preliminary report. 1922 Cmaj 1991, 145:1281-1286. 1335942 1933711
33. Walker MB Some discoveries on myasthenia gravis: The background Br Med J 1973, 2:42-43. 1588990 4572033
34. Mangano DT Miao Y Vuylsteke A Tudor IC Juneja R Filipescu D Hoeft A Fontes ML Hillel Z Ott E Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery Jama 2007, 297:471-479. 10.1001/jama.297.5.471 17284697
35. Mangano DT Tudor IC Dietzel C The risk associated with aprotinin in cardiac surgery N Engl J Med 2006, 354:353-365. 10.1056/NEJMoa051379 16436767
36. Nissen SE Wolski K Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes N Engl J Med 2007, 356:2457-2471. 10.1056/NEJMoa072761 17517853
37. Bavry AA Kumbhani DJ Helton TJ Borek PP Mood GR Bhatt DL Late thrombosis of drug-eluting stents: A meta-analysis of randomized clinical trials Am J Med 2006, 119:1056-1061. 10.1016/j.amjmed.2006.01.023 17145250
38. Shaw AD Stafford-Smith M White WD Phillips-Bute B Swaminathan M Milano C Welsby IJ Aronson S Mathew JP Peterson ED Newman MF The effect of aprotinin on outcome after coronary-artery bypass grafting N Engl J Med 2008, 358:784-793. 10.1056/NEJMoa0707768 18287601
39. Leibovici L Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infection: Randomised controlled trial Bmj 2001, 323:1450-1451. 61047 11751349 10.1136/bmj.323.7327.1450
40. Hettiaratchy S Hemsley C Effect of retroactive intercessory prayer. Paper proves power of statistics, not prayer Bmj 2002, 324:1037. author reply 1038-1039 10.1136/bmj.324.7344.1037 11977259
41. Bernard GR Vincent JL Laterre PF LaRosa SP Dhainaut JF Lopez-Rodriguez A Steingrub JS Garber GE Helterbrand JD Ely EW Fisher CJ Jr Efficacy and safety of recombinant human activated protein C for severe sepsis N Engl J Med 2001, 344:699-709. 10.1056/NEJM200103083441001 11236773
42. Nadel S Goldstein B Williams MD Dalton H Peters M Macias WL Abd-Allah SA Levy H Angle R Wang D Drotrecogin alfa (activated) in children with severe sepsis: A multicentre phase III randomised controlled trial Lancet 2007, 369:836-843. 10.1016/S0140-6736(07)60411-5 17350452
43. Abraham E Laterre PF Garg R Levy H Talwar D Trzaskoma BL Francois B Guy JS Bruckmann M Rea-Neto A Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death N Engl J Med 2005, 353:1332-1341. 10.1056/NEJMoa050935 16192478
44. Fry DE Beilman G Johnson S Williams MD Rodman G Booth FV Bates BM McCollam JS Lowry SF Safety of drotrecogin alfa (activated) in surgical patients with severe sepsis Surg Infect (Larchmt) 2004, 5:253-259. 10.1089/sur.2004.5.253 15684796
45. Chalfin DB Teres D Rapoport J A price for cost-effectiveness: implications for recombinant human activated protein C (rhAPC) Crit Care Med 2003, 31:306-308. 10.1097/00003246-200301000-00049 12545034
46. Manns BJ Lee H Doig CJ Johnson D Donaldson C An economic evaluation of activated protein C treatment for severe sepsis N Engl J Med 2002, 347:993-1000. 10.1056/NEJMsa020969 12324556
47. Berghe van den G Wouters P Weekers F Verwaest C Bruyninckx F Schetz M Vlasselaers D Ferdinande P Lauwers P Bouillon R Intensive insulin therapy in the critically ill patients N Engl J Med 2001, 345:1359-1367. 10.1056/NEJMoa011300 11794168
48. Hillman K Chen J Cretikos M Bellomo R Brown D Doig G Finfer S Flabouris A Introduction of the medical emergency team (MET) system: A cluster-randomised controlled trial Lancet 2005, 365:2091-2097. 10.1016/ S0140-6736(05)66733-5 15964445
49. Ronco C Bellomo R Homel P Brendolan A Dan M Piccinni P La Greca G Effects of different doses in continuous veno-venous haemofiltration on outcomes of acute renal failure: A prospective randomised trial Lancet 2000, 356:26-30. 10.1016/S0140-6736(00)02430-2 10892761
50. Derdak S Mehta S Stewart TE Smith T Rogers M Buchman TG Carlin B Lowson S Granton J High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: A randomized, controlled trial Am J Respir Crit Care Med 2002, 166:801-808. 10.1164/rccm.2108052 12231488
51. Rivers E Nguyen B Havstad S Ressler J Muzzin A Knoblich B Peterson E Tomlanovich M 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
52. Green LW Glasgow RE Evaluating the relevance, generalization, and applicability of research: Issues in external validation and translation methodology Eval Health Prof 2006, 29:126-153. 10.1177/0163278705284445 16510882
53. Dellinger RP Levy MM Carlet JM Bion J Parker MM Jaeschke R Reinhart K Angus DC Brun-Buisson C Beale R Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008 Crit Care Med 2008, 36:296-327. 10.1097/CCM.0b013e31817d7ee4 18158437
54. Steinberg KP Hudson LD Goodman RB Hough CL Lanken PN Hyzy R Thompson BT Ancukiewicz M Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome N Engl J Med 2006, 354:1671-1684. 10.1056/NEJMoa051693 16625008
55. Blair E Gold is not always good enough: The shortcomings of randomization when evaluating interventions in small heterogeneous samples J Clin Epidemiol 2004, 57:1219-1222. 10.1016/ j.jclinepi.2004.06.003 15617946
56. Sanson-Fisher RW Bonevski B Green LW D'Este C Limitations of the randomized controlled trial in evaluating population-based health interventions Am J Prev Med 2007, 33:155-161. 10.1016/ j.amepre.2007.04.007 17673104
57. Hiatt WR Observational studies of drug safety - aprotinin and the absence of transparency N Engl J Med 2006, 355:2171-2173. 10.1056/ NEJMp068252 17124013
58. US Food and Drug Administration (FDA) Early Communication about an Ongoing Safety Review Aprotinin Injection (marketed as Trasylol) Center for Drug Evaluation and Research 2007.
59. Mangano DT Layug EL Wallace A Tateo I Effect of atenolol on mortality and cardiovascular morbidity after noncardiac surgery. Multicenter Study of Perioperative Ischemia Research Group N Engl J Med 1996, 335:1713-1720. 10.1056/NEJM199612053352301 8929262
60. POISE Investigators Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): A randomised controlled trial Lancet 2008.
61. Herman J Shortcomings of the randomized controlled trial: A view from the boondocks J Eval Clin Pract 1998, 4:283-286. 10.1111/ j.1365-2753.1998.tb00087.x 9927239
62. Simon SD Is the randomized clinical trial the gold standard of research? J Androl 2001, 22:938-943. 11700857
63. Glasziou P Vandenbroucke JP Chalmers I Assessing the quality of research Bmj 2004, 328:39-41. 313908 14703546 10.1136/bmj.328.7430.39