Top

BMC Musculoskeletal Disorders

Published in:

Open Access 01-12-2019 | Ankle Fracture | Research article

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

Authors: Rebecca McKeown, Abdul-Rasheed Rabiu, David R. Ellard, Rebecca S. Kearney

Published in: BMC Musculoskeletal Disorders | Issue 1/2019

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.

Available only for authorised users

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.

Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures - an increasing problem? Acta Orthop Scand. 1998;69(1):43–7.CrossRefPubMed

Murray A, McDonald S, Archbold P, Crealey G. Cost description of inpatient treatment for ankle fracture. Injury. 2011;42:1226–9.CrossRefPubMed

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):430–3.CrossRefPubMed

Court-Brown CM, Duckworth AD, Clement ND, McQueen MM. Fractures in older adults. A view of the future? Injury. 2018;49(12):2161–6.CrossRefPubMed

Lin C, Donkers N, Refshauge K, Beckenkamp P, Khera K, Moseley A. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2012;11:CD005595.

Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011;128(1):305–10.CrossRefPubMedPubMedCentral

Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27:1147–57.CrossRefPubMedPubMedCentral

Mwachukwu BU, Hamid KS, Bozic KJ. Measuring value in Orthopaedic surgery. JBJS Reviews. 2013;1(1):1.CrossRef

10.

Fitzpatrick R, Davey C, Buxton M, Jones D. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2:14.

11.

Ng R, Broughton N, Williams C. Measuring recovery after ankle fractures: a systematic review of the psychometric properties of scoring systems. J Foot Ankle Surg. 2018;57(1):149–54.CrossRefPubMed

12.

Matthews PA, Scammell BE, Ollivere BJ. Letters to the editor. Re: measuring recovery after ankle fractures: a systematic review of the psychometric properties of scoring systems. J Foot Ankle Surg. 2018;57(4):854–5.CrossRefPubMed

13.

Button G, Pinney S. A meta analysis of outcome rating scales in foot and ankle surgery: is there a valid, reliable, and responsive system? Foot Ankle Int. 2004;25(8):521–5.CrossRefPubMed

14.

Moher D, Liberati A, Tetzlaff J, Altman DG, Group TP. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.CrossRefPubMedPubMedCentral

15.

Higgins JPT, Green SE. Cochrane handbook for systematic reviews of interventions: the Cochrane collaboration; 2011 [updated updated March 2011. Available from: www.handbook.cochrane.org.

16.

Blackburn EW, Aronsson DD, Rubright JH, Lisle JW. Ankle fractures in children. J Bone Joint Surg. 2012;94-A(13):1234–44.CrossRef

17.

Sirkin M, Sanders R, DiPasquale T, Herscovici D Jr. A staged protocol for soft tissue management in the treatment if complex pilon fractures. J Orthop Trauma. 1999;13(2):78–84.CrossRefPubMed

18.

Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial Pilon fractures: a review of incidence, diagnosis, treatment and complications. Acta Orthop Belg. 2011;77(4):432–40.PubMed

19.

Froud R, Patel S, Rajendran D, Bright P, Bjorkli T, Buchbinder R, et al. A systematic review of outcome measures use, analytical approaches, reporting methods and publication volume by year in low Back pain trails published between 1980 and 2012: Respice, adspice, et prospice. PLoS One. 2016;11(10):e0164573.CrossRefPubMedPubMedCentral

20.

Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg. 1984;103:190–4.CrossRefPubMed

21.

Binkley JM, Stratford PW, Lott SA, Riddle DL. The lower extremity functional scale (LEFS): scale development, measurement properties, and clinical application. Phys Ther. 1999;79(4):371–83.PubMed

22.

Busija L, Osborne RH, Nilsdotter A, Buchbinder R, Roos EM. Magnitude and meaningfulness of change in SF-36 scores in four types of orthopaedic surgery. Health Qual Life Outcomes. 2008;6(55).CrossRefPubMedPubMedCentral

23.

Dawson J, Boller I, Doll H, Lavis G, Sharp R, Cooke P, et al. The MOXFQ patient-reported questionnaire: assessment of data quality, reliability and validity in relation to foot and ankle surgery. Foot. 2011;21(2):92–102.CrossRefPubMed

24.

Johanson NA, Liang MH, Daltroy L, Rudicel S, Richmond J. American Academy of Orthopaedic surgeons lower limb outcomes assessment instruments: reliability, validity, and sensitivity to change. J Bone Joint Surg - Ser A. 2004;86(5):902–9.CrossRef

25.

Buker N, Savkin R, Gokalp O, Ok N. Validity and reliability of Turkish version of Olerud-Molander ankle score in patients with malleolar fracture. J Foot Ankle Surg. 2017;56:1209–12.CrossRefPubMed

26.

Garratt AM, Naumann MG, Sigurdsen U, Utvag SE, Stavem K. Evaluation of three patient reported outcome measures following operative fixation of closed ankle fractures. BMC Musculoskelet Disord. 2018;19(1):134 (no pagination)(134).CrossRefPubMedPubMedCentral

27.

McPhail S, Williams C, Shuetz M, Baxter B, Tonks P, Haines TP. Development and validation of the ankle fracture outcome of rehabilitation measure (A-FORM). J Orthop Sports Phys Ther. 2014;44(7):488–B2.CrossRefPubMed

28.

Mont M, Sedlin E, Weiner L, Miller A. Postoperative radiographs as predictors of clinical outcome in unstable ankle fractures. J Orthop Trauma. 1992;6(3):352–7.CrossRefPubMed

29.

Rai P, Mangwani J. Mid-term prospective follow-up of ankle fracture fixation using patient reported outcome measuresWhich Aspects of Reduction Are Most Important? AOFAS Annual Meeting 2018. Foot Ankle Orthopaed. 2018;3(3):2473011418S0039.

30.

Plant C, Parsons N, Costa M. Do radiological and functional outcomes correlate for fractures of the distal radius? Wrist Hand. 2017;99:376–82.

31.

Matthews M, Klein E, Youssef A, Weil L, Sorensen M, Weil LS, et al. Correlation of radiographic measurements with patient-centered outcomes in hallux valgus surgery. Foot Ankle Int. 2018;39(12):1416–22. https://doi.org/10.1177/1071100718790255.CrossRefPubMed

32.

van Gerven P, Weil NL, Termaat MF, Rubinstein SM, El Moumni M, Zuidema WP, et al. Routine follow-up radiographs for ankle fractures seldom add value to clinical decision-making: a retrospective, observational study. J Foot Ankle Surg. 2018;57(5):957–60.CrossRefPubMed

33.

Guyton GP. Theoretical limitations of the AOFAS scoring systems: an analysis using Monte Carlo modeling. Foot Ankle Int. 2001;22(10):779–87.CrossRefPubMed

34.

Malviya A, Makwana N, Laing P. Correlation of the AOFAS scores with a generic health Qualy score in foot and ankle surgery. Foot Ankle Int. 2007;28(4):494–8.CrossRefPubMed

35.

Pinsker E, Daniels TR. AOFAS position statement regarding the future of the AOFAS clinical rating systems. Foot Ankle Int. 2011;32(9):841–2.CrossRefPubMed

36.

Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg (Am Vol). 2013;95(16):e1181–9.

37.

Moverley R, Rankin KS, McNamara IR, Davidson DJ, Reed M, Sprowson AP. Impact factors of orthopaedic journals between 2000 and 2010: trends and comparisons with other surgical specialties. Int Orthop. 2013;37:561–7.CrossRefPubMedPubMedCentral

38.

Chan S, Bhandari M. The quality of reporting of orthopaedics randomized trials with use of a checklist for nonpharmacological therapies. J Bone Joint Surg Am. 2007;89(9):1970–8.PubMed

39.

Harish S, Vince AS, Patel AD. Routine radiography following ankle fracture fixation: a case for limiting it's use. Injury. 1999;30(10):699–701.CrossRefPubMed

Title: Primary outcome measures used in interventional trials for ankle fractures: a systematic review
Authors: Rebecca McKeown
Abdul-Rasheed Rabiu
David R. Ellard
Rebecca S. Kearney
Publication date: 01-12-2019
Publisher: BioMed Central
Keyword: Ankle Fracture
Published in: BMC Musculoskeletal Disorders / Issue 1/2019
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-019-2770-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2019

Technical variation of trans-articular sacroiliac joint (SIJ) fusion using three screws considering the effects of sacral dysplasia in patients with non-traumatic SIJ pain

Percutaneous periarticular multi-drug injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial

Multidisciplinary approach to scheduling surgery for diabetic foot: a case report

The role of wearables in spinal posture analysis: a systematic review

Outcomes and predictors of treatment failure following two-stage total joint arthroplasty with articulating spacers for evolutive septic arthritis

Proximal femoral nail anti-rotation versus cementless bipolar hemiarthroplasty for unstable femoral intertrochanteric fracture in the elderly: a retrospective study