Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2017 Feb;43(1):43-51.
doi: 10.1007/s00068-016-0720-3. Epub 2016 Sep 1.

Clinical research on postoperative trauma care: has the position of observational studies changed?

Affiliations
Review

Clinical research on postoperative trauma care: has the position of observational studies changed?

D P J Smeeing et al. Eur J Trauma Emerg Surg. 2017 Feb.

Abstract

Objective: The postoperative care regimes of ankle fractures are studied for over 30 years and recommendations have shifted only slightly in the last decades. However, study methodology might have evolved. The aim of this study was to evaluate the changes in time in the design, quality and outcome measures of studies investigating the postoperative care of ankle fractures.

Methods: The MEDLINE and EMBASE database were searched for both RCTs and cohort studies. The original studies were divided into decades of publication over the last 30 years. The methodological quality of the studies was assessed using the 'traditional' risk of bias assessment tool provided by The Cochrane Collaboration and the 'newer' MINORS criteria.

Results: The percentage of RCTs on this subject declined from 67 to 38 % in the last decades. According to the Cochrane tool, the reported quality of RCTs has improved in the last three decades whereas the reported quality of observational studies has remained unchanged. However, when quality was evaluated with the MINORS criteria, equal improvement was observed for both RCTs and observational studies. In the 80s, 67 % of all studies used the range of motion as the primary outcome measure, which decreased to 45 % in the 90s. In the 00s, none of the studies used the range of motion as the primary outcome.

Conclusion: For postoperative care of ankle fractures, results of this study showed a relative decrease in the published number of RCTs. The overall quality of the published articles did not decline. In addition, a gradual shift from physician measured to patient-reported outcome variables was observed. However, it should be borne in mind that the findings are based on a small sample (n = 25).

Keywords: Ankle fracture; Epidemiology; Postoperative care; Research perspective; Study design.

PubMed Disclaimer

Conflict of interest statement

Compliance with ethical standards There are no potential conflicts of interests. The research does not directly include patients and, therefore, informed consent was not applicable. Conflict of interest Diederik Smeeing, Roderick Houwert, Moyo Kruyt, Olivier van der Meijden, and Falco Hietbrink have no conflict of interest.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Quality RCT compared with non-randomised studies using Cochrane. Blue RCTs, green non-randomised studies. Error bars ± 1 SE
Fig. 3
Fig. 3
Quality RCT compared with non-randomised studies using MINORS. Blue RCTs, green non-randomised studies. Error bars ± 1 SE
Fig. 4
Fig. 4
Primary outcomes
Fig. 5
Fig. 5
Most patient-dependent outcome

References

    1. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312:1215–1218. doi: 10.1136/bmj.312.7040.1215. - DOI - PMC - PubMed
    1. Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285:1992–1995. doi: 10.1001/jama.285.15.1992. - DOI - PubMed
    1. Lonjon G, Boutron I, Trinquart L, et al. Comparison of treatment effect estimates from prospective nonrandomized studies with propensity score analysis and randomized controlled trials of surgical procedures. Ann Surg. 2014;259:18–25. doi: 10.1097/SLA.0000000000000256. - DOI - PubMed
    1. Ahmed AU, van der Sluis PC, Issa Y, et al. Trends in worldwide volume and methodological quality of surgical randomized controlled trials. Ann Surg. 2013;258:199–207. doi: 10.1097/SLA.0b013e31829c7795. - DOI - PubMed
    1. Fogel GR, Morrey BF. Delayed open reduction and fixation of ankle fractures. Clin Orthop Relat Res. 1987;215:187–195. - PubMed

LinkOut - more resources