Skip to main content
SpringerLink
Log in

Randomised Controlled Trials: What the Surgeon Needs to Know

  • Chapter
Key Topics in Surgical Research and Methodology

  • 2811 Accesses

Abstract

In this chapter, we discuss some of the methodological issues in the design and conduct of clinical trials of surgical rocedures. The opinion of experts in trial design, management and analysis should be sought at an early stage of a surgical clinical trial programme, recognising that other study designs may also be important including the prospective protocol-driven registry and the case control study.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 229.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 299.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 299.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Peto R, Collins R, Gray R (1995) Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol 48:23–40

    Article  PubMed  CAS  Google Scholar 

  2. Horton R (1996) Surgical research or comic opera: questions, but few answers. Lancet 347:984–985

    Article  PubMed  CAS  Google Scholar 

  3. Sculpher MJ, Seed P, Henderson RA et al (1994) Health service costs of coronary angioplasty and coronary artery bypass surgery: the Randomised Intervention Treatment of Angina (RITA) trial. Lancet 344:927–930

    Article  PubMed  CAS  Google Scholar 

  4. Yusuf S, Zucker D, Peduzzi P et al (1994) Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 344:563–570

    Article  PubMed  CAS  Google Scholar 

  5. Rahbari NN, Diener MK, Fischer L et al (2008) A concept for trial institutions focussing on randomised controlled trials in surgery. Trials 9:3

    Article  PubMed  Google Scholar 

  6. Garrett MD, Walton MI, McDonald E et al (2003) The contemporary drug development process: advances and challenges in preclinical and clinical development. Prog Cell Cycle Res 5:145–158

    PubMed  Google Scholar 

  7. Feldman AM, Koch WJ, Force TL (2007) Developing strategies to link basic cardiovascular sciences with clinical drug development: another opportunity for translational sciences. Clin Pharmacol Ther 81:887–892

    Article  PubMed  CAS  Google Scholar 

  8. Boutron I, Ravaud P, Nizard R (2007) The design and assessment of prospective randomised, controlled trials in orthopaedic surgery. J Bone Joint Surg Br 89:858–863

    PubMed  CAS  Google Scholar 

  9. Balasubramanian SP, Wiener M, Alshameeri Z et al (2006) Standards of reporting of randomized controlled trials in general surgery: can we do better? Ann Surg 244:663–667

    Article  PubMed  Google Scholar 

  10. Tiruvoipati R, Balasubramanian SP, Atturu G et al (2006) Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward. J Thorac Cardiovasc Surg 132:233–240

    Article  PubMed  Google Scholar 

  11. Burger I, Sugarman J, Goodman SN (2006) Ethical issues in evidence-based surgery. Surg Clin North Am 86:151–168; x

    Article  PubMed  Google Scholar 

  12. Boyle K, Batzer FR (2007) Is a placebo-controlled surgical trial an oxymoron? J Minim Invasive Gynecol 14:278–283

    Article  PubMed  Google Scholar 

  13. Mann CJ (2003) Observational research methods. Research design II: cohort, cross sectional, and case-control studies. Emerg Med J 20:54–60

    Article  PubMed  CAS  Google Scholar 

  14. Wolfe F (1999) Critical issues in longitudinal and observational studies: purpose, short versus long term, selection of study instruments, methods, outcomes, and biases. J Rheumatol 26:469–472

    PubMed  CAS  Google Scholar 

  15. Bridgewater B, Grayson AD, Brooks N et al (2007) Has the publication of cardiac surgery outcome data been associated with changes in practice in northwest England: an analysis of 25,730 patients undergoing CABG surgery under 30 surgeons over eight years. Heart 93:744–748

    Article  PubMed  Google Scholar 

  16. Ferguson TB Jr, Dziuban SW Jr, Edwards FH et al (2000) The STS national database: current changes and challenges for the new millennium. Committee to Establish a National Database in Cardiothoracic Surgery, The Society of Thoracic Surgeons. Ann Thorac Surg 69:680–691

    Article  PubMed  Google Scholar 

  17. Keogh BE, Bridgewater B (2007) Toward public disclosure of surgical results: experience of cardiac surgery in the United Kingdom. Thorac Surg Clin 17:403–411; vii

    Article  PubMed  Google Scholar 

  18. Chautard J, Alves A, Zalinski S et al (2008) Laparoscopic colorectal surgery in elderly patients: a matched case-control study in 178 patients. J Am Coll Surg 206:255–260

    Article  PubMed  Google Scholar 

  19. Zondervan KT, Cardon LR, Kennedy SH (2002) What makes a good case-control study? Design issues for complex traits such as endometriosis. Hum Reprod 17:1415–1423

    Article  PubMed  Google Scholar 

  20. Moran BJ (2006) Decision-making and technical factors account for the learning curve in complex surgery. J Public Health (Oxf) 28:375–378

    Article  CAS  Google Scholar 

  21. Murphy GJ, Rogers CA, Caputo M et al (2005) Acquiring proficiency in off-pump surgery: traversing the learning curve, reproducibility, and quality control. Ann Thorac Surg 80:1965–1970

    Article  PubMed  Google Scholar 

  22. Anon (1998) Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet 351:1379–1387

    Article  Google Scholar 

  23. Anon (2002) Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial. Lancet 360:965–970

    Article  Google Scholar 

  24. Barnett HJ, Taylor DW, Eliasziw M et al (1998) Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 339:1415–1425

    Article  PubMed  CAS  Google Scholar 

  25. Serruys PW, Unger F, Sousa JE et al (2001) Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med 344:1117–1124

    Article  PubMed  CAS  Google Scholar 

  26. Rothwell PM, Mehta Z, Howard SC et al (2005) Treating individuals 3: from subgroups to individuals: general principles and the example of carotid endarterectomy. Lancet 365:256–265

    PubMed  Google Scholar 

  27. Flather M, Delahunty N, Collinson J (2006) Generalizing results of randomized trials to clinical practice: reliability and cautions. Clin Trials 3:508–512

    Article  PubMed  Google Scholar 

  28. Rothwell PM (2005) Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 365:176–186

    Article  PubMed  Google Scholar 

  29. Rothwell PM (2005) External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet 365:82–93

    Article  PubMed  Google Scholar 

  30. Aziz O, Rao C, Panesar SS et al (2007) Meta-analysis of minimally invasive internal thoracic artery bypass versus percutaneous revascularisation for isolated lesions of the left anterior descending artery. BMJ 334:617

    Article  PubMed  Google Scholar 

  31. Rao C, Aziz O, Panesar SS et al (2007) Cost effectiveness analysis of minimally invasive internal thoracic artery bypass versus percutaneous revascularisation for isolated lesions of the left anterior descending artery. BMJ 334:621

    Article  PubMed  Google Scholar 

  32. McNamee P (2007) What difference does it make? The calculation of QALY gains from health profiles using patient and general population values. Health Policy 84:321–331

    Article  PubMed  Google Scholar 

  33. Vaz D, Santos L, Machado M et al (2004) Randomization methods in clinical trials. Rev Port Cardiol 23:741–755

    PubMed  Google Scholar 

  34. Perez de Arenaza D, Lees B, Flather M et al (2005) Randomized comparison of stentless versus stented valves for aortic stenosis: effects on left ventricular mass. Circulation 112:2696–2702

    Article  PubMed  Google Scholar 

  35. Smith DH, Neutel JM, Lacourciere Y et al (2003) Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements. J Hypertens 21:1291–1298

    Article  PubMed  CAS  Google Scholar 

  36. Qureshi AI, Hutson AD, Harbaugh RE et al (2004) Methods and design considerations for randomized clinical trials evaluating surgical or endovascular treatments for cerebro-vascular diseases. Neurosurgery 54:248–264; discussion 264–267

    Article  PubMed  Google Scholar 

  37. Taggart DP, Lees B, Gray A et al (2006) Protocol for the arterial revascularisation trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation [ISRCTN46552265]. Trials 7:7

    Article  PubMed  Google Scholar 

  38. Sellier P, Chatellier G, D'Agrosa-Boiteux MC et al (2003) Use of non-invasive cardiac investigations to predict clinical endpoints after coronary bypass graft surgery in coronary artery disease patients: results from the prognosis and evaluation of risk in the coronary operated patient (PERISCOP) study. Eur Heart J 24:916–926

    Article  PubMed  Google Scholar 

  39. Lim E, Drain A, Davies W et al (2006) A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery. J Thorac Cardiovasc Surg 132:1409–1413

    Article  PubMed  Google Scholar 

  40. Sedrakyan A, Wu AW, Parashar A et al (2006) Off-pump surgery is associated with reduced occurrence of stroke and other morbidity as compared with traditional coronary artery bypass grafting: a meta-analysis of systematically reviewed trials. Stroke 37:2759–2769

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Clinical Trials and Evaluation Unit, Royal Brompton Hospital and Imperial College, London, SW3 6NP, UK

    Marcus Flather

  2. Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, London, and National Heart and Lung Institute, Imperial College London, Sydney Street, London, UK

    Belinda Lees & John Pepper

Authors
  1. Marcus Flather
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Belinda Lees
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. John Pepper
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Dept. Biosurgery & Surgical Technology, Imperial College London St. Mary's Hospital London, 10th floor QEQM Bldg. Praed Street, London, W2 1NY, United Kingdom

    Thanos Athanasiou  & Ara Darzi  & 

  2. UCSF Global Health Sciences, 3333 California Street, Suite 285, San Francisco L, CA, 94143-0443, USA

    Haile Debas

Rights and permissions

Reprints and permissions

Copyright information

© 2010 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Flather, M., Lees, B., Pepper, J. (2010). Randomised Controlled Trials: What the Surgeon Needs to Know. In: Athanasiou, T., Debas, H., Darzi, A. (eds) Key Topics in Surgical Research and Methodology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-71915-1_5

Download citation

  • DOI: https://doi.org/10.1007/978-3-540-71915-1_5

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-540-71914-4

  • Online ISBN: 978-3-540-71915-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation