Evaluation framework to assess benefits and harms of bone-anchored prosthesis
2015. 6th International Conference Advances in Orthopaedic Osseointegration Page 1 of 4
Evaluation framework to assess benefits and harms of bone-anchored
prosthesis
Frossard Laurent
Queensland University of Technology, Brisbane, QLD, Australia
University of the Sunshine Coast, Maroochydore, QLD, Australia
Frossard L. Evaluation framework to assess benefits and harms of bone-anchored
prosthesis. 6th International Conference Advances in Orthopaedic Osseointegration. 2015.
Las Vegas, Nevada, USA. p 2
Introduction
Bone-anchored prostheses are increasingly
acknowledged as viable alternative method
of attachment of artificial limb compared to
socket-suspended prostheses. To date, a few
osseointegration fixations are commercially
available. Several devices are at different
stages of development particularly in Europe
and the US. [1-15]
Clearly, the current
momentum experienced worldwide is
creating a need for a standardized evaluation
framework to assess the benefits and safety
of each procedure.
Methods
The proposed evaluation framework
was extracted from a systematic review of
the literature including seminal studies
focusing on clinical benefits and safety of
procedures involving screw-type implant
(e.g., OPRA) and press-fit fixations (e.g.,
EEFT, ILP, OPL). [16-25]
Results
The literature review highlighted that a
standard and replicable evaluation
framework should focus on:
The clinical benefits with a
systematic recording of health-
related quality of life (SF-26, Q-
TFA), mobility predictor (e.g.,
AMPRO), ambulation abilities
(TUG, 6MWT), walking abilities
(e.g., characteristic spatio-temporal)
and actual activity level at baseline
and follow-up post Stage 2 surgery,
The potential harms with systematic
recording of residuum care,
infection, implant stability, implant
integrity, injuries (e.g., falls) after
Stage 1 surgery.
Discussion
There was a general consensus around the
instruments to monitor most of the benefits
and harms. The benefits could be assessed
using a wide spectrum of complementary
assessments ranging from subjective patient
self-reporting to objective measurements of
physical activity. However, this latter was
assessed using a broad range of
measurements (e.g., pedometer, load cell,
energy consumption). More importantly, the
lack of consistent grading of infections was
sufficiently noticeable to impede cross-
fixation comparisons. Clearly, a more
universal grading system is needed. In the
meanwhile, investigators are encouraged to
implement an evaluation framework
featuring the domains and instruments
proposed above using a single database to
facilitate robust prospective studies about
potential benefits and harms of their
procedure.
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Evaluation framework to assess benefits and harms of bone-anchored prosthesis
2015. 6th International Conference Advances in Orthopaedic Osseointegration Page 2 of 4
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Adj/Prof Laurent Frossard
Las Vegas, Nevada, USA
26/03/2015
Queensland University of Technology, Brisbane, QLD, Australia
University of the Sunshine Coast, Maroochydore, QLD, Australia
Evaluation framework to assess benefits and harms of bone-anchored
prosthesis
www.LaurentFrossard.com
6th International Conference Advances in Orthopaedic Osseointegration
Background
What is an evaluation framework?• Toolbox including a set of instruments to monitor the treatment and to assess the benefits and harms of bone-anchored prosthesis
• Reflective and evidence-based practice• Speed-up publications• Facilitate approvals (FDA, ISO norm)• Convince decision-makers
Background
Why an evaluation framework is needed?• Quick access to critical data• Systematic way to report progresses
Background
How to design an evaluation framework?• Purpose 1: The content
• Choice of evaluation domains• Choice of instruments
• Purpose 2: The structure • Choice of technical platform
Content – Literature review
benefits and harms of bone-anchored prosthesis
Grey literature
Specific publications
20 yrs of experience
Generic publications
Evaluation framework
Commonly accepted set of standardized evaluations
Personal notes
Content – Overview
Content – Overview
Content – Overview
Content – Overview
Content – Overview
Content – Overview
Content – Benefits
Pre-op S1 Post-op
-18mth
0mth
6mth
12mth
24mth
36mth
18mth
Rehab Community-based
Unstable Stable
Follow-ups
http://news.err.ee/v/health/895aba12-fc3e-4258-bbf8-8ba1efd5791fhttp://www.concordmonitor.com/news/nation/world/7229818-95
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Benefits
Content – Harms
S1 Post-op
0mth
6mth
12mth
24mth
36mth
18mth
Rehab Activity
Treatment-related AE Lifestyle-related AE
Op
Post-op
+mth
http://www.parrfoundation.org/http://www.drsumit.co.in/treatment-queries.html
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Content – Harms
Structure - Technical platform
Medical information
X-ray, MRI, Scans, etc…
Structure - Technical platform
Outcome measures
Benefits:SF-36, Q-TFA, TUG,
6MWT, etc…
Adverse events:Deep infection, breakage, etc…
Mainly majors events picked up at follow-
ups
Structure - Technical platform
https://www.pinterest.com/brothertedd/the-good-the-bad-and-the-ugly/
Structure - Technical platform
Patient journey
e.g., Static and dynamics load
bearing progression, first
walk, etc…
Structure - Technical platform
Incidental events
e.g., Fall, new components, etc…
Structure - Technical platform
Minor events
Minor infections treated by GP,
Self-adjustment of fixation, etc…
Not typically pickup at
follow-ups
Structure - Technical platform
Commercial software
MicrosoftExcel
MicrosoftAccess
Web-based software
400 hrs 400 hrs 500 hrs
Open source
600 hrs
Structure - Technical platform
Commercial software
MicrosoftExcel
MicrosoftAccess
Web-based software
400 hrs 400 hrs 500 hrs
Open source
600 hrs
Structure - Technical platform
cloud-based system
800 hrshttp://www.soshawaii.com/services/cloud-computing-for-oahu-businesses/.
Structure - Organisation
Easy to import and export data sets (SF-36)
https://skyvia.com/connectors/salesforce.
Structure - Organisation
Cross-correlations between cofounders and outcomes
http://gibraltardatabases.com/database_portfolio.html
Structure - Organisation
Reporting overall and individual data
http://theunboundedspirit.com/
Conclusion – Tips
1. Identify all your outcome measures first
Do the “thinking” before the “doing”!
Conclusion – Tips
1. Identify all your outcome measures first2. Implement at least the common outcomes
Make sure you are using validated instruments providing publishable data!
Conclusion – Tips
1. Identify all your outcome measures first2. Implement at least the common outcomes3. Choose a commonly used platform
Do you want to “build” or to “drive” the car?
Conclusion – Tips
1. Identify all your outcome measures first2. Implement at least the common outcomes3. Choose a commonly used platform4. Choose a flexible platform
Needs and standards change: make sure you can accommodate adjustments
Conclusion – Tips
1. Identify all your outcome measures first2. Implement at least the common outcomes3. Choose a commonly used platform4. Choose a flexible platform 5. Start building your DB with Case 1
Entering back-log of data could take a long time!
Conclusion – Tips
1. Identify all your outcome measures first2. Implement at least the common outcomes3. Choose a commonly used platform4. Choose a flexible platform 5. Start building your DB with Case 16. Generate statistically-ready outcomes
Data matter… but statistical analyses matter more!
Conclusion – To know more
Publication submitted to
APMR:
• Al Muderis M, Khemka A,
Lord S, Bosley B, Frossard
L. Clinical pathways and evaluation framework for bone-anchored prostheses: The Osseointegration Group of Australia Accelerated Protocol. 2015.
http://www.archives-pmr.org/
Conclusion – To know more
Presentation at 2nd Australasian
Osseointegrated for Amputees
Conference :
• Frossard L, Formosa D,
Quincey T, Berg D, Burkett B.
Cost effectiveness of osseointegration. 2015.
Brisbane, Australia. p 3
http://eprints.qut.edu.au/82497/
Adj/Prof Laurent Frossard
Las Vegas, Nevada, USA
26/03/2015
Queensland University of Technology, Brisbane, QLD, Australia
University of the Sunshine Coast, Maroochydore, QLD, Australia
Evaluation framework to assess benefits and harms of bone-anchored
prosthesis
www.LaurentFrossard.com
6th International Conference Advances in Orthopaedic Osseointegration
Websitewww.laurentfrossard.com
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LinkedInwww.ca.linkedin.com/pub/laurent-frossard/5/4b4/b59/
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