We expect that the Dutch language versions of the AOFAS Ankle-Hindfoot and the AOFAS Midfoot score will have adequate measurement properties (e.g. reliability and validity).
ID
Bron
Verkorte titel
Aandoening
Ankle, hindfoot, or midfoot fracture or (fracture) dislocation
Ondersteuning
Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Content validity
Achtergrond van het onderzoek
BACKGROUND
Patient-Reported Outcome Measures (PROMs) are increasingly used in order to measure (functional) recovery over time from a patient�s perspective. The AOFAS Ankle-Hindfoot Score is the most commonly used PROM for measuring outcome of treatment in patients who sustained a complex ankle or hindfoot injury. Similarly, the AOFAS Midfoot Score is a commonly used PROM for measuring outcome of treatment in patients who sustained a midfoot fracture or (fracture) dislocation. A valid, Dutch version of these instruments is currently not yet available. Such translated and validated PROMs will allow objective comparison across hospitals and with shown validity and reliability it may become a quality of care indicator in future.
AIM
1) To translate and culturally adept the AOFAS Ankle-Hindfoot Score and AOFAS Midfoot Score questionnaires into Dutch according to international guidelines, 2) to evaluate the measurement properties of the AOFAS Ankle-Hindfoot Score-Dutch Language Version (DLV) in patients with a unilateral ankle or hindfoot fracture or (fracture) dislocation, and 3) to evaluate the measurement properties of the AOFAS Midfoot Score-DLV in patients with a unilateral midfoot fracture or (fracture) dislocation.
STUDY DESIGN
Multicenter, prospective observational study.
POPULATION
Adult patients (18 years or older) presenting to the Emergency Department with a unilateral ankle, hindfoot, or midfoot fracture or (fracture) dislocation.
INTERVENTION
Not applicable, this is a questionnaire study.
ENDPOINTS
Measurement properties of the AOFAS Ankle-Hindfoot Score-DLV and the AOFAS Midfoot Score-DLV will be determined. Primary outcome measure is the content validity. Secondary outcome measures include the reliability (i.e., internal consistency, test-retest reliability, measurement error), smallest detectable change, floor and ceiling effect, and responsiveness.
RECRUITING COUNTRIES
The Netherlands.
Doel van het onderzoek
We expect that the Dutch language versions of the AOFAS Ankle-Hindfoot and the AOFAS Midfoot score will have adequate measurement properties (e.g. reliability and validity).
Onderzoeksopzet
Test-retest analysis:
1)7-9 months (ankle or midfoot) or 6-24 months (hindfoot) after injury
2) 2-3 weeks after first completion.
Responsiveness analysis:
1) between 6 weeks and 3 months (ankle or midfoot) or between 3 and 6 months (hindfoot) after injury
2) 5-6 months after first completion.
Onderzoeksproduct en/of interventie
Not applicable, this is a questionnaire study.
Algemeen / deelnemers
Mailbox H-822k 's-Gravendijkwal 230
3015 CE Rotterdam
E.M.M. van Lieshout
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
+31-10 7031050
E-mail e.vanlieshout@erasmusmc.nl
Wetenschappers
Mailbox H-822k 's-Gravendijkwal 230
3015 CE Rotterdam
E.M.M. van Lieshout
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
+31-10 7031050
E-mail e.vanlieshout@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Group 1 (test of pre-final version):
1) Patients with a unilateral ankle, hindfoot, or midfoot fracture or (fracture) dislocation
a. Ankle-Hindfoot: ankle fracture, calcaneal fracture, talar fracture, subtalar dislocation, tibiotalar dislocation, or Chopart's fracture dislocation
b. Midfoot: cuboid fracture, navicular fracture, cuneiform fracture, or Lisfranc (fracture) dislocation
2) Age 18 years or older
3) Provision of informed consent by patient.
Group 2 (validity and (test-retest) reliability):
1) Patients with a unilateral ankle, hindfoot or midfoot fracture or (fracture) dislocation
a) Ankle: ankle fracture
b) Hindfoot: calcaneal fracture, talar fracture, subtalar dislocation, tibiotalar dislocation, or Chopart's fracture dislocation
c) Midfoot: cuboid fracture, navicular fracture, cuneiform fracture, or Lisfranc (fracture) dislocation
2) Treatment started between seven and nine months (ankle and midfoot) or between six and 24 months (hindfoot) prior to the start of the study
3) Age 18 years or older
4) Povision of informed consent by patient.
Group 3 (validity and responsiveness):
1) Patients with a unilateral ankle or hindfoot fracture (as defined for group 2 above)
2) Treatment started between six weeks and three months (ankle and midfoot) or between three and six months (hindfoot) prior to the start of the study
3) Age 18 years or older
4) Provision of informed consent by patient.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) Multiple trauma patient (if additional injury limits function at time of enrolment)
2) Pathological fracture
3) Severe physical comorbidity (ASA ¡Ý3)
4) Patient was non-ambulatory prior to the injury
5) Insufficient comprehension of the Dutch language to understand and complete the questionnaires
6) Patients with expected problems of maintaining follow-up
For testing the pre-final version of the Dutch AOFAS Ankle-Hindfoot or Midfoot Score (group 1), only exclusion criteria 5 and 6 will apply.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5469 |
| NTR-old | NTR5613 |
| Ander register | : MEC-2014-215 (METC Erasmus MC) |
Samenvatting resultaten
<br><br>
- De Boer AS, Tjioe RJC, Van der Sijde F, Meuffels DE, Den Hoed PT, Van der Vlies CH, Tuinebreijer WE, Verhofstad MHJ, Van Lieshout EMM, AOFAS study Group. The American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score; Translation and Validation of the Dutch Language Version for ankle fractures. BMJ Open. 2017 Aug 3;7(8):e017040.
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- De Boer AS, Meuffels DE, Van der Vlies CH, Den Hoed PT, Tuinebreijer WE, Verhofstad MHJ, Van Lieshout EMM, AOFAS study Group. Validation of the American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale Dutch Language Version in Patients with Hindfoot Fractures. De Boer AS, et al. BMJ Open 2017;7:e018314.