Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2009

Open Access 01-12-2009 | Review

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

Author: Jonathan A Cook

Published in: Trials | Issue 1/2009

Login to get access

Abstract

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.
Appendix
Available only for authorised users
Literature
1.
2.
3.
4.
5.
Fransen M, Anderson C, Douglas J, MacMahon S, Neal B, Norton R, Woodward M, Cameron ID, Crawford R, Lo SK, Tregonning G, Windolf M, 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. 2006, 333: 519-CrossRefPubMedPubMedCentral
6.
Medical Research Council: Streptomycin treatment of pulmonary tuberculosis. BMJ. 1948, 2: 769-782.CrossRef
7.
8.
9.
Stirrat GM, Farrow SC, Farndon J, Dwyer N: The challenge of evaluating surgical interventions. Ann R Coll Surg Engl. 1992, 74: 80-84.PubMedPubMedCentral
10.
Deeks JJ, Dinnes J, D'Amico R, Sowden AJ, Sakarovitch C, Song F, Petticrew M, Altman D: Evaluating non-randomised intervention studies. Health Technol Assess. 2003, 7: 1-173.CrossRef
11.
12.
Solomon MJ, McLeod RS: Clinical Studies in surgical journals – have we improved?. Dis Colon Rectum. 1993, 36: 43-48.CrossRefPubMed
13.
Ko CY, Sack J, Chang JT, Fink A: Reporting randomised, controlled trials: where quality of reporting may be improved. Dis Colon Rectum. 2002, 45: 443-447.CrossRefPubMed
14.
Wente MN, Seiler CM, Uhl W, Büchler MW: Perspectives of evidence-based surgery. Dig Surg. 2003, 20: 263-269.CrossRefPubMed
15.
Ellis J, Mulligan I, Rowe J, Sackett DL: Inpatient general medicine is evidence based. Lancet. 1995, 364: 407-410.
16.
Howes N, Chagla L, Thorpe M, McCulloch P: Surgical practice is evidence based. Br J Surg. 1997, 84: 1220-1223.CrossRefPubMed
17.
Kenny SE, Shankar KR, Rintula R, Lamont GL, Lloyd DA: Evidence-based surgery: interventions in a regional paediatric surgical unit. Arch Dis Child. 1997, 76: 50-53.CrossRefPubMedPubMedCentral
18.
Agha R, Cooper D, Muir G: The reporting quality of randomised controlled trials in surgery: A systematic review. Int J Surg. 2007, 5: 413-422.CrossRefPubMed
19.
Bhandari M, Guyatt GH, Lochner H, Sprague S, Tronetta P: Application of the consolidated standards of reporting trials (CONSORT) in the fracture care literature. J Bone Joint Surg Am. 2002, 84A: 485-489.
20.
Hall JC, Mills B, Nguyen H, Hall JL: Methodologic standards in surgical trials. Surgery. 1996, 119: 466-472.CrossRefPubMed
21.
22.
Chalmers TC: Randomized clinical trials in surgery. Controversy in Surgery. Edited by: Varco RL, Delaney JP. 1976, Philadelphia: WB Saunders, 3-11.
23.
Haines SJ: Randomized clinical trials in the evaluation of surgical innovation. J Neurosurg. 1979, 51: 5-11.CrossRefPubMed
24.
van Der Linden W: Pitfalls in randomized surgical trials. Surgery. 1980, 7: 258-262.
25.
Pollock AV: The rise and fall of the randomised controlled trial in surgery. Theor Surg. 1989, 4: 163-170.
26.
Solomon MJ, McLeod RS: Should we be performing more randomized controlled trials evaluating surgical operations?. Surgery. 1995, 118: 459-467.CrossRefPubMed
27.
28.
29.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-CrossRefPubMedPubMedCentral
30.
Mowatt G, Bower DJ, Brebner JA, Cairns JA, Grant AM, McKee L: When and how to assess fast-changing technologies: a comparative study of medical applications of four generic technologies. Health Technol Assess. 1997, 1: 14-
31.
Johnasson O, Reda D: General Surgery. Textbook of clinical trials. Edited by: Machin D, Day S, Green S. 2006, Chichester: John Wiley & Sons, Ltd, 543-552. 2CrossRef
32.
Campbell WB, Barnes SJ, Kirby RA, Willett SL, Wortley S, Lyratzopoulos G: Association of study type, sample size, and follow-up length with type of recommendation produced by the National Institute for Health and Clinical Excellence Interventional Interventions Programme. Int J Technol Assess Health Care. 2007, 23: 101-107.CrossRefPubMed
33.
Cook JA, Ramsay CR, Fayers P: Statistical evaluation of learning curve effects in surgical trials. Clin Trials. 2004, 1: 421-427.CrossRefPubMed
34.
35.
Ramsay CR, Grant AM, Wallace SA, Garthwaite PH, Monk AF, Russell IT: Statistical assessment of the learning curves of health technologies. Health Technol Assess. 2001, 5: 1-79.CrossRefPubMed
36.
Mann M, Tendulkar A, Birger N, Howard C, Ratcliffe MB: National institutes of health funding for surgical research. Ann Surg. 2008, 247: 217-221.CrossRefPubMed
37.
Cook JA, Ramsay CR, Norrie J: Recruitment to publicity funded trials – Are surgical trials really different?. Contemp Clin Trials. 2008, 29: 631-634.CrossRefPubMedPubMedCentral
38.
Kuppermann M, Varner RE, Summitt RL, Learman LA, Ireland C, Vittinghoff E, Stewart AL, Lin F, Richter HE, Showstack J, Hulley SB, Washington AE, 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. 2004, 291: 1447-1455.CrossRefPubMed
39.
Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH: Need for expertise based randomised controlled trials. BMJ. 2005, 330: 88-CrossRefPubMedPubMedCentral
40.
Prescott R, Counsell C, Gillespie W, Grant A, Russell I, Kiauka S, Colthart IR, Ross S, Shephard SM, Russell S: Factors that limit the quality, number and progress of randomized controlled trials. Health Technol Assess. 1999, 3: 1-142.PubMed
41.
McDonald A, Knight R, Campbell MK, Entwistle V, Grant A, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C: What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006, 7: 9-CrossRefPubMedPubMedCentral
42.
43.
Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters t, Frankel S, Neal D, Hamdy F: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002, 325: 766-770.CrossRefPubMedPubMedCentral
44.
Keating JF, Grant A, Masson M, Scott NW, Forbes 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. 2005, 9: 41-CrossRef
45.
46.
47.
Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA: Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006, 296: 2441-2450.CrossRefPubMedPubMedCentral
48.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group: Methods and Processes of the CONSORT Group: Example of an extension for Trials assessing nonpharmacologic treatments. Ann Intern Med. 2008, 148: W60-W67.PubMed
49.
Bonenkamp JJ, Songun I, Hermans J, Sasako M, Welvaart K, Plukker JT, van Elk P, Obertop H, Gouma DJ, Taat CW, Van Lanschot J, Meyer S, De Graaf PW, Von Meyenfeldt MF, Tilanus H, Velde Van De CJH: Randomized comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients. Lancet. 1995, 345: 745-748.CrossRefPubMed
50.
51.
Wellwood J, Sculpher MJ, Stoker D, Nicholls GJ, Geddes C, Whitehead A, Singh R, Spiegelhalter D: Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost. BMJ. 1998, 317: 103-110.CrossRefPubMedPubMedCentral
52.
Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J, Reda D, Henderson W, for the Veterans Affairs Cooperative Studies Program: Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004, 350: 1819-1827.CrossRefPubMed
53.
Vickers AJ, Bianco FJ, Serio AM, Eastham JA, Schrag D, Klein EA, Reuther AM, Kattan MW, Pontes JE, Scardino PT: The surgical learning curve for prostate cancer control after radical prostatectomy. J Natl Cancer Inst. 2007, 99: 1171-1177.CrossRefPubMed
54.
Cook JA, Ramsay CR, Fayers P: Using the literature to quantify the learning curve. nt J Technol Assess Health Care. 2007, 23: 255-260.
55.
Schulz KF, Chalmers I, Altman DG: The landscape and lexicon of blinding in randomized trials. Ann Intern Med. 2002, 136: 254-259.CrossRefPubMed
56.
Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P: Reporting methods of blinding in randomized controlled trials assessing non pharmacological treatments. PLos Med. 2007, 4: 371-379.CrossRef
57.
Douek M, Smith G, Oshowo A, Stoker DL, Wellwood JM: Prospective randomised controlled trial of laparoscopic versus open inguinal hernia mesh repair: Five year follow up. BMJ. 2003, 326: 1012-1013.CrossRefPubMedPubMedCentral
58.
Poolman RW, Struijs PA, Krips R, Sierevelt IN, Marti RK, Farrokhyar F, Bhandari M: Reporting of outcomes in orthopaedic randomized trials: does blind of outcome assessors matter?. J Bone Joint Surg. 2007, 89: 550-558.CrossRefPubMed
59.
Chan S, Bhandari M: The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies. J Bone Joint Surg Am. 2007, 89: 1970-1978.CrossRefPubMed
60.
Majeed AW, Troy G, Nicholl JP, Smythe A, Reed MW, Stoddard CJ, Peacock J, Johnson AG: Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet. 1996, 347: 989-994.CrossRefPubMed
61.
London AJ, Kadane JB: Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res. 2002, 11: 413-427.CrossRefPubMed
62.
Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP: A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002, 347: 81-88.CrossRefPubMed
63.
64.
Roberts C, Roberts SA: Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials. 2005, 2: 152-162.CrossRefPubMed
65.
Diener MK, Knaebel HP, Witte ST, Rossion I, Kieser M, Buchler MW, Seiler CM, DISPACT Trial Group: DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy – study rationale and design. Clin Trials. 2008, 5: 534-545.CrossRefPubMed
66.
Rothwell P: Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet. 2005, 365: 176-186.CrossRefPubMed
67.
White IR: Uses and limitations of randomization-based efficacy estimators. Stat Methods Med Res. 2005, 14: 327-347.CrossRefPubMed
68.
Fergusson D, Aaron SD, Guyatt G, Hébert P: Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002, 325: 652-654.CrossRefPubMedPubMedCentral
Metadata
Title
The challenges faced in the design, conduct and analysis of surgical randomised controlled trials
Author
Jonathan A Cook
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-9

Other articles of this Issue 1/2009

Trials 1/2009 Go to the issue

Study protocol

Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial – The NeuroMorfeo trial

Research

Quality of reporting of randomized controlled trials in polycystic ovary syndrome

Study protocol

Hypertension Improvement Project (HIP): study protocol and implementation challenges

Study protocol

The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection tools

Research

Paying clinicians to join clinical trials: a review of guidelines and interview study of trialists

Study protocol

Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively