Abstract
In the hierarchy of research designs, randomised controlled trials and meta-analyses of randomised controlled trials are considered to be the highest level of evidence. They have been established as essential areas of research since their introduction into clinical sciences. Research in the interventional disciplines such as surgery, rely mostly on observational studies. Therefore, the quality and quantity of randomised trials with regards to interventions remain limited. Researchers in these disciplines face various obstacles during building, assessment or implementation of evidence. This chapter aims to provide a critical overview of the obstacles to randomised trials and meta-analyses. It also proposes solution to these problems.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
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.
MRC_Investigation. Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. BMJ. 1948;2:769-782.
Egger M, Smith GD, Phillips AN. Meta-analysis: principles and procedures. BMJ. 1997;315:1533-1537.
Huque MF. Experiences with meta-analysis in NDA submissions. Proc Biopharm Sect Am Stat Assoc. 1988;2:28-33.
Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med. 1982;72:233-240.
Farrokhyar F, Karanicolas PJ, Thoma A, et al. Randomized controlled trials of surgical interventions. Ann Surg. 2010;251:409-416.
Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312:1215-1218.
Solomon MJ, McLeod RS. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery. 1995;118:459-467.
Shaw LW, Chalmers TC. Ethics in cooperative clinical trials. Ann NY Acad Sci. 1970;169:487-495.
Weijer C, Shapiro SH, Cranley Glass K. For and against: clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. BMJ. 2000;321:756-758.
McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324:1448-1451.
Barkun JS, Barkun AN, Sampalis JS, et al. Randomised controlled trial of laparoscopic versus mini cholecystectomy. The McGill Gallstone Treatment Group. Lancet. 1992;340:1116-1119.
McMahon AJ, Russell IT, Baxter JN, et al. Laparoscopic versus minilaparotomy cholecystectomy: a randomised trial. Lancet. 1994;343:135-138.
Neugebauer E, Troidl H, Kum CK, Eypasch E, Miserez M, Paul A. The E.A.E.S. Consensus development conferences on laparoscopic cholecystectomy, appendectomy, and hernia repair. Consensus statements – September 1994. The Educational Committee of the European Association for Endoscopic Surgery. Surg Endosc. 1995;9:550-563.
Ahmed K, Khan MS, Vats A, et al. Current status of robotic assisted pelvic surgery and future developments. Int J Surg. 2009;7:431-440.
Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM, Pruthi RS. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. Eur Urol. 2010;57:196-201.
Ouriel K. The PIVOTAL study: a randomized comparison of endovascular repair versus surveillance in patients with smaller abdominal aortic aneurysms. J Vasc Surg. 2009;49:266-269.
Solomon MJ, Laxamana A, Devore L, McLeod RS. Randomized controlled trials in surgery. Surgery. 1994;115:707-712.
Solomon MJ, McLeod RS. Surgery and the randomised controlled trial: past, present and future. Med J Aust. 1998;169:380-383.
Hall JC, Mills B, Nguyen H, Hall JL. Methodologic standards in surgical trials. Surgery. 1996;119:466-472.
Diamond GA, Forrester JS. Clinical trials and statistical verdicts: probable grounds for appeal. Ann Intern Med. 1983;98:385-394.
Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet. 1991;337:867-872.
Hochman JS, Sleeper LA, Godfrey E, et al. Should we emergently revascularize Occluded Coronaries for cardiogenic shock: an international randomized trial of emergency PTCA/CABG-trial design. The SHOCK Trial Study Group. Am Heart J. 1999;137:313-321.
Hochman JS, Sleeper LA, White HD, et al. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001;285:190-192.
van der Linden W. Pitfalls in randomized surgical trials. Surgery. 1980;87:258-262.
Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials. N Engl J Med. 1983;309:1358-1361.
McCulloch P. Developing appropriate methodology for the study of surgical techniques. J R Soc Med. 2009;102:51-55.
Parikh D, Johnson M, Chagla L, Lowe D, McCulloch P. D2 gastrectomy: lessons from a prospective audit of the learning curve. Br J Surg. 1996;83:1595-1599.
Testori A, Bartolomei M, Grana C, et al. Sentinel node localization in primary melanoma: learning curve and results. Melanoma Res. 1999;9:587-593.
Bonenkamp JJ, Songun I, Hermans J, et al. Randomised comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients. Lancet. 1995;345:745-748.
Bonenkamp JJ, Hermans J, Sasako M, et al. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999;340:908-914.
McCulloch P. D1 versus D2 dissection for gastric cancer. Lancet. 1995;345:1516-1517. author reply 1517–1518.
Sauerland S, Seiler CM. Role of systematic reviews and meta-analysis in evidence-based medicine. World J Surg. 2005;29:582-587.
Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629-634.
Slim K, Raspado O, Brugere C, Lanay-Savary MV, Chipponi J. Failure of a meta-analysis on the role of elective surgery for left colonic diverticulitis in young patients. Int J Colorectal Dis. 2008;23:665-667.
Hernandez AV, Walker E, Ioannidis JP, Kattan MW. Challenges in meta-analysis of randomized clinical trials for rare harmful cardiovascular events: the case of rosiglitazone. Am Heart J. 2008;156:23-30.
Borzak S, Ridker PM. Discordance between meta-analyses and large-scale randomized, controlled trials. Examples from the management of acute myocardial infarction. Ann Intern Med. 1995;123:873-877.
Cappelleri JC, Ioannidis JP, Schmid CH, et al. Large trials vs meta-analysis of smaller trials: how do their results compare? JAMA. 1996;276:1332-1338.
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.
Bailar JC 3rd. The promise and problems of meta-analysis. N Engl J Med. 1997;337:559-561.
Lau J, Ioannidis JP, Schmid CH. Summing up evidence: one answer is not always enough. Lancet. 1998;351:123-127.
Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992;327:248-254.
Huston P, Naylor CD. Health services research: reporting on studies using secondary data sources. CMAJ. 1996;155:1697-1709.
Wachter KW. Disturbed by meta-analysis? Science. 1988;241:1407-1408.
Abrams KR, Gillies CL, Lambert PC. Meta-analysis of heterogeneously reported trials assessing change from baseline. Stat Med. 2005;24:3823-3844.
Ioannidis JP, Patsopoulos NA, Evangelou E. Uncertainty in heterogeneity estimates in meta-analyses. BMJ. 2007;335:914-916.
Davey Smith G, Egger M, Phillips AN. Meta-analysis. Beyond the grand mean? BMJ. 1997;315:1610-1614.
Rosenberg MS. The file-drawer problem revisited: a general weighted method for calculating fail-safe numbers in meta-analysis. Evolution. 2005;59:464-468.
Peters JL, Sutton AJ, Jones DR, Abrams KR, Rushton L. Comparison of two methods to detect publication bias in meta-analysis. JAMA. 2006;295:676-680.
Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1-12.
Oxman AD. Checklists for review articles. BMJ. 1994;309:648-651.
Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet. 1999;354:1896-1900.
Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000;283:2008-2012.
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
Juni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999;282:1054-1060.
Huedo-Medina TB, Sanchez-Meca J, Marin-Martinez F, Botella J. Assessing heterogeneity in meta-analysis: Q statistic or I2 index? Psychol Methods. 2006;11:193-206.
Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539-1558.
Bailey KR. Inter-study differences: how should they influence the interpretation and analysis of results? Stat Med. 1987;6:351-360.
Sevdalis N, Jacklin R. Interaction effects and subgroup analyses in clinical trials: more than meets the eye? J Eval Clin Pract. 2008;14:919-922.
Cook DI, Gebski VJ, Keech AC. Subgroup analysis in clinical trials. Med J Aust. 2004;180:289-291.
Mayer EK, Bottle A, Rao C, Darzi AW, Athanasiou T. Funnel plots and their emerging application in surgery. Ann Surg. 2009;249:376-383.
Duval S, Tweedie R. Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics. 2000;56:455-463.
Gray SM. Knowledge management: a core skill for surgeons who manage. Surg Clin North Am. 2006;86:17-39. vii-viii.
Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg. 1997;84:1220-1223.
Kingston R, Barry M, Tierney S, Drumm J, Grace P. Treatment of surgical patients is evidence-based. Eur J Surg. 2001;167:324-330.
Meakins JL. Evidence-based surgery. Surg Clin North Am. 2006;86:1-16. vii.
Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet. 2009;374:1097-1104.
Knight T, Brice A. Librarians, surgeons, and knowledge. Surg Clin North Am. 2006;86:71-90. viii–ix.
Glasziou P. Managing the evidence flood. Surg Clin North Am. 2006;86:193-199. xi.
Lee MJ. Evidence-based surgery: creating the culture. Surg Clin North Am. 2006;86:91-100. ix.
McCulloch P, Badenoch D. Finding and appraising evidence. Surg Clin North Am. 2006;86:41-57. viii.
Ahmed K, Ashrafian H. Life-long learning for physicians. Science. 2009;326:227.
Ahmed K, Jawad M, Dasgupta P, Darzi A, Athanasiou T, Khan MS. Assessment and maintenance of competence in urology. Nat Rev Urol. 2010;7:403-413.
Arora S, Sevdalis N, Suliman I, Athanasiou T, Kneebone R, Darzi A. What makes a competent surgeon?: experts’ and trainees’ perceptions of the roles of a surgeon. Am J Surg. 2009;198:726-732.
Satava RM, Gallagher AG, Pellegrini CA. Surgical competence and surgical proficiency: definitions, taxonomy, and metrics. J Am Coll Surg. 2003;196:933-937.
Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials. 2006;1:e9.
Marshall JC. Surgical decision-making: integrating evidence, inference, and experience. Surg Clin North Am. 2006;86:201-215. xii.
Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59:877-883.
Sevdalis N, McCulloch P. Teaching evidence-based decision-making. Surg Clin North Am. 2006;86:59-70. viii.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2011 Springer London
About this chapter
Cite this chapter
Ahmed, K., Sevdalis, N., Darzi, A., Athanasiou, T. (2011). Barriers to Evidence Synthesis. In: Darzi, A., Athanasiou, T. (eds) Evidence Synthesis in Healthcare. Springer, London. https://doi.org/10.1007/978-0-85729-206-3_2
Download citation
DOI: https://doi.org/10.1007/978-0-85729-206-3_2
Published:
Publisher Name: Springer, London
Print ISBN: 978-0-85729-175-2
Online ISBN: 978-0-85729-206-3
eBook Packages: MedicineMedicine (R0)