Pro-con debate: Cohort studies vs the randomized clinical trial methodology in pediatric anesthesia: Pro-Con Debate

Paediatric Anaesthesia

Volumn 20, Issue 9, 2010, Pages 880-894

  Hansen, Tom G ^a   Henneberg, Steen W ^b   Morton, Neil S ^c   Christensen, Kaare ^d   Davidson, Andrew J ^e,f   Lee, Katherine J ^f   Hardy, Pollyanna ^f   Wolf, Andrew ^g  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b University of Copenhagen   (Denmark)

^c ROYAL HOSPITAL FOR SICK CHILDREN   (United Kingdom)

^d UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^e ROYAL CHILDREN'S HOSPITAL   (Australia)

^f MURDOCH CHILDREN'S RESEARCH INSTITUTE   (Australia)

^g BRISTOL ROYAL HOSPITAL FOR CHILDREN   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

THALIDOMIDE;

ADVERSE OUTCOME; BRAIN DEVELOPMENT; CASE CONTROL STUDY; CAUSAL ATTRIBUTION; CESAREAN SECTION; CHI SQUARE TEST; CHILD BEHAVIOR CHECKLIST; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COHORT ANALYSIS; CONFOUNDING VARIABLE; CONTROL GROUP; COST MINIMIZATION ANALYSIS; DATA BASE; EPIDEMIOLOGY; FOLLOW UP; GENERAL ANESTHESIA; GOLD STANDARD; HERNIOPLASTY; HUMAN; INCIDENCE; INFORMATION SYSTEM; INFORMED CONSENT; INTERMETHOD COMPARISON; KAPLAN MEIER METHOD; LEARNING DISORDER; LINEAR REGRESSION ANALYSIS; LOG RANK TEST; LOGISTIC REGRESSION ANALYSIS; MEDICAL ETHICS; MEDICAL RECORD REVIEW; MEDICAL RESEARCH; MONOZYGOTIC TWINS; NEUROTOXICITY; OBSERVATIONAL STUDY; OBSERVER BIAS; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PEDIATRIC ANESTHESIA; PEDIATRIC SURGERY; PHOCOMELIA; POPULATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROPOFOL INFUSION SYNDROME; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RECALL BIAS; REGIONAL ANESTHESIA; RELIABILITY; REVIEW; RISK FACTOR; SAMPLE SIZE; SCORING SYSTEM; STRATIFIED SAMPLE; SURVIVAL TIME; SYSTEMATIC ERROR; TREATMENT RESPONSE; VALIDITY;

ANESTHESIOLOGY; CHILD; COHORT STUDIES; EVIDENCE-BASED MEDICINE; HUMANS; PATIENT SELECTION; PEDIATRICS; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGRESSION ANALYSIS; RESEARCH DESIGN; RISK ASSESSMENT; SELECTION BIAS;

EID: 77955798109     PISSN: 11555645     EISSN: 14609592     Source Type: Journal    
DOI: 10.1111/j.1460-9592.2010.03367.x     Document Type: Review

References (45)

1. Mayer D. Essential Evidence Based Medicine.
2. http://www.cebm.net/levels-of-evidence.asp
3. Myles PS, Leslie K, McNeil J. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet 2004 363 : 1757 1763.
4. Avidan MS, Zhang L, Burnside BA et al. Anesthesia awareness and the bispectral index. N Engl J Med 2008 358 : 1097 1108.
5. Van den Berghe G, Wouters P, Weekers F et al. Intensive insulin therapy in critically ill patients. N Engl J Med 2001 345 : 1359 1367.
6. Van den Berghe G, Wilmer A, Hermans G et al. Intensive insulin therapy in the medical ICU. N Engl J Med 2006 354 : 449 461.
7. Malmberg K, Ryden L, Wedel H et al. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infaction (DIGAMI 2): effects on mortality and morbidity. Eur Heart J 2005 26 : 650 661.
8. Anand KJ, Barton BA, McIntosh N. Analgesia and sedation in preterm neonates who require ventilatory support: results from the NOPAIN trial. Neonatal Outcome and Prolonged Analgesia in Neonates. Arch Pediatr Adolesc Med 1999 153 : 331 338.
9. Anand KJS, Hall RW, Desai N et al. Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial. Lancet 2004 363 : 1673 1682.
10. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000 342 : 1887 1892.
11. Benson K, Hartz AJ. A comparison of observational studies and randomized controlled trials. N Engl J Med 2000 342 : 1878 1886.
12. Pocock SJ, Elbourne DR. Randomized trials or observational tribulations? N Engl J Med 2000 342 : 1907 1909.
13. Barton S. Which clinical studies provide the best evidence? The best RCT still trumps the best observational study. BMJ 2000 321 : 255 256.
14. Von Elm E, Altman DG, Egger M et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 2007 147 : 573 577. (Pubitemid 351664504)
15. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996 312 : 1215 1218.
16. McKee M, Britton A, Black N et al. Methods in health services research. Interpreting the evidence: choosing between randomised and non-randomised controlled studies. BMJ 1991 1999 : 312 315.
17. Hodgson R, Bushe C, Hunter R. Measurement of long-term outcomes in observational and randomised controlled trials. Br J Psychiatry Suppl 2007 191 (Suppl. 50 s78 s84.
18. Davidson AJ, McCann ME, Morton NS et al. Anesthesia and outcome after neonatal surgery: the role for randomized trials. Anesthesiology 2008 109 : 941 944.
19. Wilder RT, Flick RP, Sprung J et al. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology 2009 110 : 796 804.
20. Kalkman CJ, Peelen L, Moons KG et al. Behaviour and development in children and age at the time of first anesthetic exposure. Anesthesiology 2009 110 : 805 812.
21. DiMaggio C, Sun LS, Kakavouli A et al. A retrospective cohort study of the association of anesthesia and hernia repair surgery with behavioral and developmental disorders in young children. J Neurosurg Anesthesiol 2009 21 : 286 291.
22. Bartels M, Althoff RR, Boomsma DI. Anesthesia and cognitive performance in children: no evidence for a causal relationship. Twin Res Hum Genet 2009 12 : 246 253.
23. Sprung J, Flick RP, Wilder RT et al. Anesthesia for caesarean delivery and learning disabilities in a population-based birth cohort. Anesthesiology 2009 111 : 302 310.
24. Rothwell PM. Treating Individuals 1. External validity of randomised controlled trials: To whom do the results of this trial apply? Lancet 2005 365 : 82 93.
25. Parke TJ, Stevens JE, Rice AS et al. Metabolic acidosis and fatal myocardial failure after propofol infusion in children: five case reports. BMJ 1992 305 : 613 616.
26. Rochon PA, Gurwitz JH, Sykora K et al. Reader's guide to critical appraisal of cohort studies: 1. Role and design. BMJ 2005 330 : 895 897.
27. Vandenbroucke JP, von Elm E, Altman DG et al. Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. Ann Intern Med 2007 147 : w163 w194. (Pubitemid 351664503)
28. Mamdani M, Sykora K, Li P et al. Reader's guide to critical appraisal of cohort studies: 2. Assessing potential for confounding. BMJ 2005 330 : 960 962. (Pubitemid 40592320)
29. Normand SLT, Sykora K, Li P et al. Reader's guide to critical appraisal of cohort studies: 3. Analytical strategies to reduce confounding. BMJ 2005 330 : 1021 1023. (Pubitemid 40604289)
30. Wunsch H, Linde-Zwirble WT, Angus DC. Methods to adjust for bias and confounding in critical care health services research involving observational data. J Crit Care 2006 21 : 1 7.
31. Altman DG, Schulz KF, Moher D et al. The revised CONSORT statement for reporting randomized clinical trials: explanation and elaboration. Ann Intern Med 2001 134 : 663 694.
32. Brennan P, Croft P. Education and debate. Interpreting the results of observational research: chance is not such a fine thing. BMJ 1994 309 : 727 730.
33. Assmann SF, Pocock SJ, Enos LE et al. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000 355 : 1064 1069.
34. Hansen TG, Danish Registry Study Group, Flick R Mayo Clinic Pediatric Anesthesia and Learning Disabilities Study Group. Anesthetic effects on the developing brain: insights from epidemiology. Anesthesiology 2009 110 : 1 3.
35. Guyatt GH, DiCenso A, Farewell V et al. Randomized trials versus observational studies in adolescent pregnancy prevention. J Clin Epidemiol 2000 53 : 167 174.
36. Hemminki E, McPherson K. Impact of postmenopausal hormone therapy on cardiovascular events and cancer: pooled data from clinical trials. BMJ 1997 315 : 149 153. (Pubitemid 27303059)
37. MacLehose RR, Reeves BC, Harvey IM et al. A systematic review of comparisons of effect sizes derived from randomised and non-randomised studies. Health Technol Assess 2000 4 : 1 154.
38. Omenn GS, Goodman GE, Thornquist MD et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 1996 334 : 1150 1155.
39. Altman DG, Bland JM. Statistics notes. Treatment allocation in controlled trials: why randomise?. BMJ 1999 318 : 1209.
40. Cummings S, Grady D, Hulley S. Designing a randomized blinded trial. In : Hulley S, Cummings S, Browner W, Grady D, eds. Designing Clinical Research, 3rd edn.
41. Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003 327 : 1459 1461.
42. Davidson AJ, O'Brien M. Ethics and medical research in children. Paediatr Anaesth 2009 19 : 994 1004.
43. Weiss M, Dullenkopf A, Fischer JE et al. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth 2009 103 : 867 873.
44. Lopez U, Habre W. Evaluation of intraoperative memory and postoperative behavior in children: are we really measuring what we intend to measure? Paediatr Anaesth 2009 19 : 1147 1151.
45. Zwarenstein M, Treweek S, Gagnier JJ et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008 337 : a2390.