Evaluation framework to assess benefits and harms of...

Evaluation framework to assess benefits and harms of bone-anchored prosthesis

2015. 6th International Conference Advances in Orthopaedic Osseointegration 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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2014. In press.

Adj/Prof Laurent Frossard

Las Vegas, Nevada, USA

26/03/2015




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 – 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 – 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

Structure - Technical platform

Medical information

X-ray, MRI, Scans, etc…


Outcome measures

Benefits:SF-36, Q-TFA, TUG,

6MWT, etc…

Adverse events:Deep infection, breakage, etc…

Mainly majors events picked up at follow-

ups


https://www.pinterest.com/brothertedd/the-good-the-bad-and-the-ugly/


Patient journey

e.g., Static and dynamics load

bearing progression, first

walk, etc…


Incidental events

e.g., Fall, new components, etc…


Minor events

Minor infections treated by GP,

Self-adjustment of fixation, etc…

Not typically pickup at

follow-ups


Commercial software

MicrosoftExcel

MicrosoftAccess

Web-based software

400 hrs 400 hrs 500 hrs

Open source

600 hrs


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.


Cross-correlations between cofounders and outcomes

http://gibraltardatabases.com/database_portfolio.html


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




prosthesis

www.LaurentFrossard.com

6th International Conference Advances in Orthopaedic Osseointegration

Websitewww.laurentfrossard.com

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