Top

European Journal of Trauma and Emergency Surgery

Published in:

Open Access 01-04-2021 | Original Article

Study methodology in trauma care: towards question-based study designs

Authors: Roderick M. Houwert, Reinier B. Beks, Marcel G. W. Dijkgraaf, Kit C. B. Roes, F. Cumhur Öner, Falco Hietbrink, Luke P. H. Leenen, Rolf H. H. Groenwold

Published in: European Journal of Trauma and Emergency Surgery | Issue 2/2021

Abstract

The randomized controlled trial (RCT) in surgery may not always be ethical, feasible, or necessary to address a particular research question about the effect of a surgical intervention. If so, properly designed and conducted observational (non-randomized) studies may be valuable alternatives for an RCT and produce credible results. In this paper, we discus differences between RCTs and observational studies and differentiate between three types of comparisons of surgical interventions. We assert that results of different designs should be regarded as complementary to each other when evaluating surgical interventions. Criteria for credible observational research are presented to provide guidance for future observational research of surgical interventions. We argue that the research question that is being asked should guide the discussion about the value of a particular study design.

Crofton J, Mitchison DA. Streptomycin treatment of pulmonary tuberculosis. Br Med J. 1948;2(4582):769–82.CrossRef

Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312(7040):1215–8.CrossRef

McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12.CrossRef

EC/IC Bypass Study Group. Failure of extracranial–intracranial arterial bypass to reduce the risk of ischemic stroke. N Engl J Med. 1985;313(19):1191–200.CrossRef

Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81–8.CrossRef

McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324(7351):1448–511.CrossRef

Ochen Y, Beks RB, van Heijl M, Hietbrink F, Leenen LPH, van der Velde D, et al. Operative treatment versus nonoperative treatment of Achilles tendon ruptures: systematic review and meta-analysis. BMJ. 2019;364:k5120.CrossRef

Beks RB, Peek J, de Jong MB, Wessem KJP, Öner CF, Hietbrink F, et al. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2018;45(4):631–44.CrossRef

Beks RB, Ochen Y, Frima H, Smeeing DPJ, van der Meijden O, Timmers TK, et al. Operative versus nonoperative treatment of proximal humeral fractures: a systematic review, meta-analysis, and comparison of observational studies and randomized controlled trials. J Shoulder Elb Surg. 2018;27(8):1526–34.CrossRef

10.

Houwert RM, Smeeing DP, Ahmed Ali U, Hietbrink F, Kruyt MC, van der Meijden OA. Plate fixation or intramedullary fixation for midshaft clavicle fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies. J Shoulder Elb Surg. 2016;25(7):1195–203.CrossRef

11.

Beks R, Bhashyam AR, Houwert R, van der Velde D, van Heijl M, Smeeing D, et al. When observational studies are as helpful as randomized trials. J Trauma Acute Care Surg. 2019;87:730–2.CrossRef

12.

Sibai T, Carlisle H, Tornetta P. The darker side of randomized trials: recruitment challenges. J Bone Joint Surg Am. 2012;94(Suppl 1):49–55.CrossRef

13.

Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, et al. Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial. JAMA. 2015;313(10):1037.CrossRef

14.

Nowak LL, Vicente MR, McKee MD, Hall JA, Nauth A, Schemitsch EH. Orthopaedic surgeons’ opinions surrounding the management of proximal humerus fractures: an international survey. Int Orthop. 2017;41(9):1749–55.CrossRef

15.

Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, et al. Need for expertise based randomised controlled trials. BMJ. 2005;330(7482):88.CrossRef

16.

Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009;10(1):9.CrossRef

17.

Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887–922.CrossRef

18.

Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342(25):1878–86.CrossRef

19.

Ioannidis JPA, Haidich A-B, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA. 2001;286(7):821–30.CrossRef

20.

Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H. Comparison of effects in randomized controlled trials with observational studies in digestive surgery. Ann Surg. 2006;244(5):668–76.CrossRef

21.

Edwards JP, Kelly EJ, Lin Y, Lenders T, Ghali WA, Graham AJ. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery. Can J Surg. 2012;55(3):155–62.CrossRef

22.

Kunz R, Oxman AD. The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. BMJ. 1998;317(7167):1185–90.CrossRef

23.

Vandenbroucke JP. Observational research, randomised trials, and two views of medical science. PLoS Med. 2008;5(3):e67.CrossRef

24.

Groenwold RHH, Hak E, Hoes AW. Quantitative assessment of unobserved confounding is mandatory in nonrandomized intervention studies. J Clin Epidemiol. 2009;62(1):22–8.CrossRef

25.

Beks RB, Houwert RM, Groenwold RHH. Added value of observational studies in surgery: the hierarchical structure of study designs requires a more refined approach. Ned Tijdschr Geneeskd. 2017;161:D1493.PubMed

26.

Zuidgeest MG, Goetz I, Grobbee DE. PRECIS-2 in perspective: what is next for pragmatic trials? J Clin Epidemiol. 2017;84:22–4.CrossRef

27.

Lemans JVC, Wijdicks SPJ, Boot W, Govaert GAM, Houwert RM, Öner FC, et al. Intrawound treatment for prevention of surgical site infections in instrumented spinal surgery: a systematic comparative effectiveness review and meta-analysis. Glob Spine J. 2018;9:219–30.CrossRef

28.

Smeeing DPJ, Houwert RM, Briet JP, Groenwold RHH, Lansink KWW, Leenen LPH, et al. Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures: a multicenter randomized controlled trial. Eur J Trauma Emerg Surg. 2018. https://doi.org/10.1007/s00068-018-1016-6.

29.

Bhandari M, Guyatt GH, Swiontkowski MF, Tornetta P, Hanson B, Weaver B, et al. Surgeons’ preferences for the operative treatment of fractures of the tibial shaft. J Bone Jt Surg. 2001;83:1746–52.CrossRef

30.

Wijdicks FJ, Houwert M, Dijkgraaf M, de Lange D, Oosterhuis K, Clevers G, et al. Complications after plate fixation and elastic stable intramedullary nailing of dislocated midshaft clavicle fractures: a retrospective comparison. Int Orthop. 2012;36(10):2139–45.CrossRef

31.

Beks RB, Reetz D, de Jong MB, Groenwold RHH, Hietbrink F, Edwards MJR, et al. Rib fixation versus non-operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma: a multicenter cohort study. Eur J Trauma Emerg Surg. 2018;45(4):655–63.CrossRef

32.

Beks RB, de Jong MB, Sweet A, Peek J, van Wageningen B, Tromp T, et al. Multicentre prospective cohort study of nonoperative versus operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma: study protocol. BMJ Open. 2019;9(8):e023660.CrossRef

33.

Viele K, Berry S, Neuenschwander B, Amzal B, Chen F, Enas N, et al. Use of historical control data for assessing treatment effects in clinical trials. Pharm Stat. 2014;13(1):41–544.CrossRef

34.

Schmidt AF, Klugkist I, Klungel OH, Nielen M, de Boer A, Hoes AW, et al. Bayesian methods including nonrandomized study data increased the efficiency of postlaunch RCTs. J Clin Epidemiol. 2015;68(4):387–96.CrossRef

35.

Darvishian M, Gefenaite G, Turner RM, Pechlivanoglou P, Van der Hoek W, Van den Heuvel ER, et al. After adjusting for bias in meta-analysis seasonal influenza vaccine remains effective in community-dwelling elderly. J Clin Epidemiol. 2014;67(7):734–44.CrossRef

36.

van der Vliet QMJ, van Maarseveen OEC, Smeeing DPJ, Houwert RM, van Wessem KJP, Simmermacher RKJ, et al. Severely injured patients benefit from in-house attending trauma surgeons. Injury. 2019;50(1):20–6.CrossRef

37.

Stadhouder A, Buskens E, de Klerk LW, Verhaar JA, Dhert WA, Verbout AJ, et al. Traumatic thoracic and lumbar spinal fractures: operative or nonoperative treatment: comparison of two treatment strategies by means of surgeon equipoise. Spine (Phila Pa 1976). 2008;33(9):1006–177.CrossRef

38.

Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, Orgill DP, Pagano D, et al. The STROCSS statement: strengthening the reporting of cohort studies in surgery. Int J Surg. 2017;46:198–202.CrossRef

39.

Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso-Coello P, et al. GRADE guidelines: 9. rating up the quality of evidence. J Clin Epidemiol. 2011;64(12):1311–6.CrossRef

Title: Study methodology in trauma care: towards question-based study designs
Authors: Roderick M. Houwert
Reinier B. Beks
Marcel G. W. Dijkgraaf
Kit C. B. Roes
F. Cumhur Öner
Falco Hietbrink
Luke P. H. Leenen
Rolf H. H. Groenwold
Publication date: 01-04-2021
Publisher: Springer Berlin Heidelberg
Published in: European Journal of Trauma and Emergency Surgery / Issue 2/2021
Print ISSN: 1863-9933
Electronic ISSN: 1863-9941
DOI: https://doi.org/10.1007/s00068-019-01248-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Study methodology in trauma care: towards question-based study designs

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 2/2021

Effects of negative-pressure therapy with and without ropivacaine instillation in the early evolution of severe peritonitis in pigs

Nonunion of fractures in children

Third day laboratory follow-up: mandatory for surgical site infections of tibial plateau fractures

Mortality after abdominal emergency surgery in nonagenarians

Central venous oxygen saturation/lactate ratio: a novel predictor of outcome following emergency open laparotomy

Idarucizumab in major trauma patients: a single centre real life experience