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The challenges faced in the design, conduct and analysis of surgical randomised trials

By Jonathan Alistair Cook


Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials

Topics: Randomised Controlled Trials as Topic, Research Design, Surgical Procedures, Operative
Publisher: BMC
Year: 2009
OAI identifier:

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  1. (1996). AG: Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet
  2. (2003). Altman D: Evaluating non-randomised intervention studies. Health Technol Assess
  3. (2002). Altman DG: The landscape and lexicon of blinding in randomized trials. Ann Intern Med
  4. (2003). Büchler MW: Perspectives of evidence-based surgery. Dig Surg
  5. Council UK: Developing and evaluating complex interventions: new guidance. [ plexinterventionsguidance].
  6. (2002). D: Randomised trials in surgery: problems and possible solutions. BMJ
  7. (1995). De: Randomized comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients. Lancet
  8. (2005). Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials
  9. (2006). Deyo RA: Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA
  10. (2008). DISPACT Trial Group: DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy – study rationale and design. Clin Trials
  11. (1995). DL: Inpatient general medicine is evidence based. Lancet
  12. (2004). Ethics and evidence based surgery.
  13. (1995). Evaluating new surgical interventions. BMJ
  14. (1997). Evidencebased surgery: interventions in a regional paediatric surgical unit. Arch Dis Child
  15. (1999). Factors that limit the quality, number and progress of randomized controlled trials. Health Technol Assess
  16. (2004). Fayers P: Statistical evaluation of learning curve effects in surgical trials. Clin Trials
  17. (2007). Fayers P: Using the literature to quantify the learning curve. nt J Technol Assess Health Care
  18. (2002). Fink A: Reporting randomised, controlled trials: where quality of reporting may be improved. Dis Colon Rectum
  19. (2008). for the CONSORT Group: Methods and Processes of the CONSORT Group: Example of an extension for Trials assessing nonpharmacologic treatments. Ann Intern Med
  20. (2006). for the HIPAID Collaborative Group: Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial. BMJ
  21. (2004). for the Veterans Affairs Cooperative Studies Program: Open mesh versus laparoscopic mesh repair of inguinal hernia.
  22. General Surgery. In Textbook of clinical trials 2nd edition. Edited by:
  23. (2005). Guyatt GH: Need for expertise based randomised controlled trials. BMJ
  24. (2002). Hamdy F: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ
  25. (2008). Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ
  26. (2002). Innovation in surgery.
  27. (1985). Is surgery worthwhile? Arch Surg
  28. (1999). Issues in surgical randomized controlled trials.
  29. (2001). IT: Statistical assessment of the learning curves of health technologies. Health Technol Assess
  30. (2005). JF: Displaced intracapsular hip fractures in fit, older people: a randomised comparison of reduction and fixation, bipolar hemiarthroplasty and total hip arthroplasty. Health technol Assess
  31. (1996). JL: Methodologic standards in surgical trials. Surgery
  32. (2002). Kadane JB: Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res
  33. (2007). Lyratzopoulos G: Association of study type, sample size, and followup length with type of recommendation produced by the National Institute for Health and Clinical Excellence Interventional Interventions Programme. Int J Technol Assess Health Care
  34. (2008). MB: National institutes of health funding for surgical research. Ann Surg
  35. (1993). McLeod RS: Clinical Studies in surgical journals – have we improved? Dis Colon Rectum
  36. (1995). McLeod RS: Should we be performing more randomized controlled trials evaluating surgical operations? Surgery
  37. (1948). Medical Research Council: Streptomycin treatment of pulmonary tuberculosis.
  38. (2004). Ms Research Group: Effect of hysterectomy vs medical treatment on health-related quality of life and sexual functioning: the medicine or surgery (Ms) randomized trial. JAMA
  39. (2002). NP: A controlled trial of arthroscopic surgery for osteoarthritis of the knee.
  40. (1980). Pitfalls in randomized surgical trials. Surgery
  41. (2002). Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ
  42. (2003). Prospective randomised controlled trial of laparoscopic versus open inguinal hernia mesh repair: Five year follow up. BMJ
  43. (1975). Randomization of the first patient. Med Clin North Am
  44. Randomized clinical trials in surgery.
  45. (1979). Randomized clinical trials in the evaluation of surgical innovation.
  46. (2007). Ravaud P: Reporting methods of blinding in randomized controlled trials assessing non pharmacological treatments. PLos Med
  47. (2008). Recruitment to publicity funded trials – Are surgical trials really different? Contemp Clin Trials
  48. (2007). Scardino PT: The surgical learning curve for prostate cancer control after radical prostatectomy.
  49. (2000). SJ: Trials and fast changing technologies: the case for tracker studies. BMJ
  50. (2006). Snowdon C: What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials
  51. (1991). Some problems with clinical trials. Arch Surg
  52. (1998). Spiegelhalter D: Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost. BMJ
  53. (2005). Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet
  54. (1993). Surgical evaluation at the crossroads.
  55. (1997). Surgical practice is evidence based.
  56. (2004). T: Trials in surgery.
  57. (1992). The challenge of evaluating surgical interventions. Ann R Coll Surg Engl
  58. (1983). The practical and ethical defects of surgical randomised prospective trials.
  59. (2007). The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies. J Bone Joint Surg Am
  60. (2007). The reporting quality of randomised controlled trials in surgery: A systematic review.
  61. (1989). The rise and fall of the randomised controlled trial in surgery. Theor Surg
  62. (2005). Treatment allocation by minimisation. BMJ
  63. (2002). Tronetta P: Application of the consolidated standards of reporting trials (CONSORT) in the fracture care literature.
  64. (2005). Uses and limitations of randomization-based efficacy estimators. Stat Methods Med Res
  65. (2008). Waiting times for scoliosis surgery. Lancet
  66. (1998). What is Zelen's design? BMJ
  67. (1997). When and how to assess fast-changing technologies: a comparative study of medical applications of four generic technologies. Health Technol Assess

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