Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies.Objectives
Methods
Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.Objectives
Methods
A rigorous approach to developing, delivering and documenting
rehabilitation within randomised controlled trials of surgical interventions
is required to underpin the generation of reliable and usable evidence.
This article describes the key processes used to ensure provision
of good quality and comparable rehabilitation to all participants
of a multi-centre randomised controlled trial comparing surgery
with conservative treatment of proximal humeral fractures in adults. These processes included the development of a patient information
leaflet on self-care during sling immobilisation, the development
of a basic treatment physiotherapy protocol that received input
and endorsement by specialist physiotherapists providing patient
care, and establishing an expectation for the provision of home
exercises. Specially designed forms were also developed to facilitate
reliable reporting of the physiotherapy care that patients received.Objectives
Methods
To investigate the differences of open reduction and internal
fixation (ORIF) of complex AO Type C distal radius fractures between
two different models of a single implant type. A total of 136 patients who received either a 2.4 mm (n = 61)
or 3.5 mm (n = 75) distal radius locking compression plate (LCP
DR) using a volar approach were followed over two years. The main
outcome measurements included motion, grip strength, pain, and the
scores of Gartland and Werley, the Short-Form 36 (SF-36) and the
Disabilities of the Arm, Shoulder, and Hand (DASH). Differences
between the treatment groups were evaluated using regression analysis
and the likelihood ratio test with significance based on the Bonferroni
corrected p-value of <
0.003.Objectives
Methods
