Injury, Int. J.
Care Injured 42 (2011) 231
Contents lists available at ScienceDirect
Injury
journal homepage: www.elsevier.com/locate/injury
Editorial
Assessing patient outcomes: Pearls for clinical practice and research
The ‘‘outcomes’’ movement in orthopaedic surgery involves
careful attention to the design of clinical research. The delineation
between ‘‘outcomes’’ research and ‘‘evidence-based medicine’’
remains vague.11 Central to practicing evidence based orthopae-
dics involves integration of our clinical expertise and judgement
with patients’ perceptions and societal values, and with the best
available research evidence. Evidence becomes more trustworthy
when it reflects the underlying ‘truth’ about a particular treatment
and its outcome. Fundamental to the reduction of bias in clinical
research is the choice of valid and reliable outcomes.
The choice of the ideal outcome in a clinical study has become
increasingly complex, largely due to the variety of measures
promoted in orthopaedics.1–5 The search term ‘orthopaedic
outcomes’ retrieves over 3.5 million webpages in the Google
search engine and over 6500 publications in PubMED. The
consistency in which outcomes are chosen or applied in the
orthopaedic literature is highly variable.
Given the ever-increasing body of outcomes used in orthopae-
dics,6–10 we enlisted the support of several researchers with
experience in orthopaedic clinical research to provide a practical
guide to outcomes assessment. Getting outcomes assessment right
requires a basic understanding of the language of the outcomes
movement. To this end, we provide readers with a primer on
validity, reliability and criteria for evaluating the quality of an
outcome. We further provide annotated checklists of existing
outcome measures across a variety of injuries including shoulder,
hand and wrist, spine, hip, knee and foot and ankle. We provide
insight into outcomes following severe trauma, and post traumatic
stress disorder as well as head injury.
Despite decades of fracture research, we continue to struggle
with basic definitions of healing including fracture healing as well
as spine fusion. Our symposium addresses the literature focusing
on fracture healing and spine fusion with a goal to provide
recommended guidelines for clinical research. Operationalising
fracture healing outcomes in today’s environment requires
specialised infrastructure and outcome assessment tools. We
present guidelines for outcomes adjudication in fracture healing
trials to emphasise the practical aspects of endpoint committees in
research and regulatory requirements when evaluating a device or
drug.
The purpose of the ‘‘outcomes movement’’ and ‘‘evidence-based
medicine’’ is to provide surgeons with tools that allow them to
gather, access, interpret, and summarise the evidence. It is not an
end in itself, but rather a set of principles and tools that help us
ultimately provide better patient care.
We hope that this special issue will become a practical guide to
outcomes assessment and will assist both clinicians and research-
0020–1383/$ – see front matter ß 2010 Elsevier Ltd. All rights reserved.
doi:10.1016/j.injury.2010.11.055
ers in making the right choice of the ideal outcome measure in
trauma and orthopaedic surgery.
References
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3. Clay FJ, Newstead SV, McClure RJ. A systematic review of early prognostic
factors for return to work following acute orthopaedic trauma. Injury
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4. Fraschini G, Ciampi P, Scotti C, et al. Surgical treatment of chronic acromio-
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injured patients with peripheral nerve lesions. Injury 2010;41(5):540–3.
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8. Moumni M, Voogd EH, Duis HJ, Wendt KW. Long-term functional outcome
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Mohit Bhandari
Division of Orthopaedic Surgery, Department of Surgery,
McMaster University, Hamilton, Ontario, Canada
Peter V. Giannoudis*
Academic Department of Trauma and Orthopaedics,
School of Medicine, University of Leeds,
LIMM Section of Musculoskeletal Disease, LGI, Clarendon Wing,
Great George St, LS1 3EX Leeds, UK
*Corresponding author. Tel.: +44 113 392 2750;
fax: +44 113 392 3290
E-mail address: pgiannoudi@aol.com (P.V. Giannoudis)
bhandam@mcmaster.ca
(M. Bhandari)