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
. 2019 Aug 28;20(1):388.
doi: 10.1186/s12891-019-2770-2.

Primary outcome measures used in interventional trials for ankle fractures: a systematic review

Rebecca McKeown  1 , Abdul-Rasheed Rabiu  2 , David R Ellard  3 , Rebecca S Kearney  3
Affiliations

Primary outcome measures used in interventional trials for ankle fractures: a systematic review

Rebecca McKeown et al. BMC Musculoskelet Disord. .

Abstract

Background: Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture.

Methods: We performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type.

Results: The searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980's.

Conclusion: This review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results.

Keywords: Ankle; Ankle fractures; Ankle injuries; Outcome measures; Patient reported outcome measures; Randomised controlled trials.

PubMed Disclaimer

Conflict of interest statement

RSK is a member of the UK NIHR HTA CET board, NIHR ICA Doctoral board and NIHR RfPB board.

Figures

Fig. 1
Fig. 1
PRISMA Diagram
Fig. 2
Fig. 2
Bar chart showing frequency of use of most commonly used eight primary outcome measures in included studies
Fig. 3
Fig. 3
Bar chart showing frequency of multi-item PROM use in included studies
Fig. 4
Fig. 4
Graph showing temporal trends of most commonly used five outcome measures
See this image and copyright information in PMC

References

    1. McPhail S, Dunstan J, Canning J, Haines T. Life impact of ankle fractures: qualitative analysis of patient and clinician experiences. BMC Musculoskelet Disord. 2012;13:224. - PMC - PubMed
    1. Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures - an increasing problem? Acta Orthop Scand. 1998;69(1):43–47. doi: 10.3109/17453679809002355. - DOI - PubMed
    1. Murray A, McDonald S, Archbold P, Crealey G. Cost description of inpatient treatment for ankle fracture. Injury. 2011;42:1226–1229. doi: 10.1016/j.injury.2010.08.023. - DOI - PubMed
    1. Kannus P, Palvanen M, Niemi S, Parkkari J, Jarvinnen M. Increasing number and incidence of low-trauma ankle fractures in ederly people: Finnish statistics during 1970–2000 and projections for the future. Bone. 2002;31(3):430–433. doi: 10.1016/S8756-3282(02)00832-3. - DOI - PubMed
    1. Court-Brown CM, Duckworth AD, Clement ND, McQueen MM. Fractures in older adults. A view of the future? Injury. 2018;49(12):2161–2166. doi: 10.1016/j.injury.2018.11.009. - DOI - PubMed

Publication types

MeSH terms