Skip to main content

Advertisement

SpringerLink
Log in

How Does an Historic Control Study of a Surgical Procedure Compare With the “Gold Standard”?

  • Published:
Diseases of the Colon & Rectum

Purpose

It has been suggested that nonrandomized studies of interventions can neither discriminate between the effect of an intervention and that of bias nor accurately estimate the magnitude of measured effects. This study was designed to compare the results of an historic control study of a surgical procedure with those of a subsequent randomized control trial conducted under similar circumstances.

Methods

The results of an historic control study and a randomized, controlled trial of the safety and efficacy of laparoscopic rectopexy for rectal prolapse that were conducted 17 months apart by the same group of surgeons at the same institution were compared in terms of direction and magnitude of measured effects.

Results

The historic control study was reliable in determining the direction of measured effects in six of six (100 percent) outcomes common between the two studies, and there was agreement on the statistical significance (or lack of it) in five (83 percent); however, the magnitude of measured effects for all but one outcome assessed was 33 to 107 percent larger than in the randomized, controlled trial. There was no agreement in the medical literature on the effect of the historic control design on the direction and magnitude of measured effects.

Conclusions

The results of a surgical historic control trial compared favorably with those of a randomized, controlled trial conducted under similar circumstances in determining the direction of measured effects but tended to yield larger estimates of effect magnitudes. The medical literature is divided on the effect of the historic control study design on study outcomes and more research is required to further define its role in evidence-based surgery.

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

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. MJ Solomon RS McLeod (1993) ArticleTitleClinical studies in surgical journals - have we improved? Dis Colon Rectum 36 43–48 Occurrence Handle8416778 Occurrence Handle1:STN:280:ByyC3crnsVQ%3D Occurrence Handle10.1007/BF02050300

    Article  PubMed  CAS  Google Scholar 

  2. RL Moss MC Henry RA Dimmitt S Rangel N Geraghty ED Skarsgard (2001) ArticleTitleThe role of prospective randomized clinical trials in pediatric surgery: state of the art? J Pediatr Surg 36 1182–1186 Occurrence Handle11479852 Occurrence Handle1:STN:280:DC%2BD3MvjtFygtQ%3D%3D Occurrence Handle10.1053/jpsu.2001.25749

    Article  PubMed  CAS  Google Scholar 

  3. R Peto R Collins R Gray (1995) ArticleTitleLarge-scale randomized evidence: large, simple trials and overviews of trials J Clin Epidemiol 48 23–40 Occurrence Handle7853045 Occurrence Handle1:STN:280:ByqC2MnhtFw%3D Occurrence Handle10.1016/0895-4356(94)00150-O

    Article  PubMed  CAS  Google Scholar 

  4. H Sacks TC Chalmers H Smith (1982) ArticleTitleRandomization versus historic controls for clinical trials Am J Med 72 233–240 Occurrence Handle7058834 Occurrence Handle1:STN:280:Bi2C3s3ntVQ%3D Occurrence Handle10.1016/0002-9343(82)90815-4

    Article  PubMed  CAS  Google Scholar 

  5. JN Miller GA Colditz F Mosteller (1989) ArticleTitleHow study design affects outcomes in comparisons of therapy. II: Surgical Stat Med 8 455–466 Occurrence Handle2727469 Occurrence Handle1:STN:280:BiaB28nislI%3D

    PubMed  CAS  Google Scholar 

  6. GA Colditz JN Miller F Mosteller (1989) ArticleTitleHow study design affects outcomes in comparisons of therapy. I: Medical Stat Med 8 441–454 Occurrence Handle2727468 Occurrence Handle1:STN:280:BiaB28nislE%3D

    PubMed  CAS  Google Scholar 

  7. RR MacLehose BC Reeves IM Harvey TA Sheldon IT Russell AM Black (2000) ArticleTitleA systematic review of comparisons of effect sizes derived from randomised and non-randomised studies Health Technol Assess 4 34

    Google Scholar 

  8. A Britton M McKee N Black K McPherson C Sanderson C Bain (1998) ArticleTitleChoosing between randomised and non-randomised studies: a systematic review Health Technol Assess 2 IssueIDi–iv 1–124 Occurrence Handle10103353

    PubMed  Google Scholar 

  9. K Benson AJ Hartz (2000) ArticleTitleA comparison of observational studies and randomized, controlled trials N Engl J Med 342 1878–1886 Occurrence Handle10861324 Occurrence Handle1:STN:280:DC%2BD3czgt1Chsg%3D%3D Occurrence Handle10.1056/NEJM200006223422506

    Article  PubMed  CAS  Google Scholar 

  10. J Concato N Shah I Ralph MD Horwitz (2000) ArticleTitleRandomized, controlled trials, observational studies, and the hierarchy of research designs N Engl J Med 342 1887–1892 Occurrence Handle10861325 Occurrence Handle1:STN:280:DC%2BD3czgt1Chsw%3D%3D Occurrence Handle10.1056/NEJM200006223422507

    Article  PubMed  CAS  Google Scholar 

  11. R Kunz AD Oxman (1998) ArticleTitleThe unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials BMJ 317 1185–1190 Occurrence Handle9794851 Occurrence Handle1:STN:280:DyaK1M%2FhtlOruw%3D%3D

    PubMed  CAS  Google Scholar 

  12. J Ioannidis AB Haidich M Pappa et al. (2001) ArticleTitleComparisons between randomised and non-randomised evidence JAMA 286 821–830 Occurrence Handle11497536 Occurrence Handle1:STN:280:DC%2BD3Mvmslyqug%3D%3D Occurrence Handle10.1001/jama.286.7.821

    Article  PubMed  CAS  Google Scholar 

  13. MJ Solomon AA Eyers (1996) ArticleTitleLaparoscopic rectopexy using mesh fixation with a spiked chromium staple Dis Colon Rectum 39 279–284 Occurrence Handle8603548 Occurrence Handle1:STN:280:BymC1cvkslw%3D Occurrence Handle10.1007/BF02049468

    Article  PubMed  CAS  Google Scholar 

  14. MJ Solomon CJ Young AA Eyers RA Roberts (2002) ArticleTitleRandomized clinical trial of laparoscopic versus open abdominal rectopexy for rectal prolapse Br J Surg 89 35–39 Occurrence Handle11851660 Occurrence Handle1:STN:280:DC%2BD387hvVCntg%3D%3D Occurrence Handle10.1046/j.0007-1323.2001.01957.x

    Article  PubMed  CAS  Google Scholar 

  15. JG Neely JM Hartman JW Forsen SuffixJr MS Wallace (2003) ArticleTitleTutorials in clinical research: VII. Understanding comparative statistics (contrast)—part B: application of T-test, Mann-Whitney U, and chi-square Laryngoscope 113 1719–1725 Occurrence Handle14520096 Occurrence Handle10.1097/00005537-200310000-00011

    Article  PubMed  Google Scholar 

  16. KF Schulz I Chalmers RJ Hayers DG Altman (1995) ArticleTitleEmpirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials JAMA 273 408–412 Occurrence Handle7823387 Occurrence Handle1:STN:280:ByqC38zntFI%3D Occurrence Handle10.1001/jama.273.5.408

    Article  PubMed  CAS  Google Scholar 

  17. RJ Horwitz CM Viscoli JD Clemens RT Sadock (1990) ArticleTitleDeveloping improved observational methods for evaluating therapeutic effectiveness Am J Med 89 630–638 Occurrence Handle1978566 Occurrence Handle1:STN:280:By6D2M7lvFA%3D Occurrence Handle10.1016/0002-9343(90)90182-D

    Article  PubMed  CAS  Google Scholar 

  18. RI Horwitz AR Feinstein (1979) ArticleTitleMethodologic standards and contradictory results in case-control research Am J Med 66 556–564 Occurrence Handle433963 Occurrence Handle1:STN:280:CSaC283ntlQ%3D Occurrence Handle10.1016/0002-9343(79)91164-1

    Article  PubMed  CAS  Google Scholar 

  19. P Jüni A Witschi R Bloch M Egger (1999) ArticleTitleThe hazards of scoring the quality of clinical trials for meta-analysis JAMA 282 1054–1060 Occurrence Handle10493204 Occurrence Handle10.1001/jama.282.11.1054

    Article  PubMed  Google Scholar 

  20. JS Torgerson L Sjostrom (2001) ArticleTitleThe Swedish Obese Subjects (SOS) Study – rationale and results Int J Obes Relat Metab Disord 25 S2–S4 Occurrence Handle11466577 Occurrence Handle10.1038/sj/ijo/0801687

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Coffs Harbour Health Campus, Faculty of Medicine, The University of New South Wales, Locked Bag 812 Coffs Harbour, NSW, 2450, Australia

    Ned S. Abraham M.B.B.S.(Hons.), M.M.(ClinEpid.) F.R.A.C.S., F.R.C.S.

  2. Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, Australia

    Ramu DuraiRaj M.B.B.S., Christopher J. Young M.B.B.S., F.R.A.S.C. & Michael J. Solomon M.B.B.Ch.(Hons.), M.Sc.(ClinEpid.), F.R.A.C.S.

  3. The Surgical Outcomes Research Centre, Sydney South West Area Health Service, The University of Sydney, Sydney, Australia

    Jane M. Young M.B.B.S., M.P.H., Ph.D., F.A.F.P.H.M., Christopher J. Young M.B.B.S., F.R.A.S.C. & Michael J. Solomon M.B.B.Ch.(Hons.), M.Sc.(ClinEpid.), F.R.A.C.S.

Authors
  1. Ned S. Abraham M.B.B.S.(Hons.), M.M.(ClinEpid.) F.R.A.C.S., F.R.C.S.
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ramu DuraiRaj M.B.B.S.
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jane M. Young M.B.B.S., M.P.H., Ph.D., F.A.F.P.H.M.
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Christopher J. Young M.B.B.S., F.R.A.S.C.
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Michael J. Solomon M.B.B.Ch.(Hons.), M.Sc.(ClinEpid.), F.R.A.C.S.
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ned S. Abraham M.B.B.S.(Hons.), M.M.(ClinEpid.) F.R.A.C.S., F.R.C.S..

About this article

Cite this article

Abraham, N.S., DuraiRaj, R., Young, J.M. et al. How Does an Historic Control Study of a Surgical Procedure Compare With the “Gold Standard”?. Dis Colon Rectum 49, 1141–1148 (2006). https://doi.org/10.1007/s10350-006-0614-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10350-006-0614-2

Key words

Search

Navigation