aopa lit review 2013.ppt - american orthotic and ... · pdf file• medicare reimbursed...

10/15/2013

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Prosthetic Management Following Transtibial Amputation

A Systematic Review of High Quality Literature from 1997 to 2012

M. Jason Highsmith, PhD, DPT, CP, FAAOPAssistant Professor

University of South FloridaCollege of Medicine

School of Physical Therapy & Rehabilitation Sciences

The Team

• Jason T. Kahle, MSMS, CPO, FAAOP

• Amanda L. Lewandowski, DPT

• John J. Orriola, MEd

• Jan P. Ertl, MD

• Bryce Sutton, PhD

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Background

TTA in the United States:

• ≈185,000 amputations annually

• 1.6M persons living with limb loss

• ≈1.3M (86%) have LE amputation

• 28% LE amputees (≈378,000) have TTA– 72% of TTAs in the U.S. due to PVD

• higher incidence & prevalence of dysvascular amputation with:– advancing age

– & black individuals have highest incidence of any particular group

– remaining 18%, 7% of TTA’s are from trauma

Background• Impairments associated with TTA:

– Gait (biomechanical/energetic)

– Balance/falls/safety

• TTAs develop 2˚ conditions related to:– sound limb overuse

– sub-optimal/poor alignment

• Conditions may include:– degenerative joint disease

– osteopenia

• Many w/ TTA:– lead functional lifestyles

– at times, participate in sports/athletics

• How do we get there?

– Muscle

– Body image

– sub-optimal movement patterns

– postural issues

– low back pain & others

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BackgroundCosts: transtibial prosthesis use

• considerable lifetime healthcare expense

• Blough et al.: individual lifetime prosthetic costs w/ unilateral LEA ≈$0.5-1.8M depending on factors including:– # prostheses in service at a given time

– Type(s) of prostheses

• Collectively: U.S. societal costs of dysvascular amputee care ≈$4.3B

• Medicare reimbursed $655M worth of lower limb prosthetic services in 2009

Background

• Purpose: to look broadly at the highest quality of evidence available to guide clinical practice for patients with transtibialamputation

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Methods• multi-disciplinary review team:

physical therapists prosthetists health economist

orthopaedic surgeon information scientist

biostatistician

• met 3x to outline search methodology:– multiple databases

– key search terms (1˚ & 2 ˚) to cover key domains from purpose

– search methods based on broad view of TTA re prosthetic mgt

– Preliminary searches conducted & outcomes previewed to assure adequate inclusion of key articles (quantity, quality, specificity).

– search statement planned to be sensitive to condition/intervention but prosthetic/amputation literature sometimes multi-subject, i.e., TTAs might be w/ other groups (i.e. TFA) so statement enhanced to include any prosthesis involving any part of the LE

Methods

Primary Search Term Set

• (prosthe* OR "Prostheses and Implants"[Mesh] OR prosthesis OR prostheses OR preprosthe* OR pre-prosthe*)

AND

• (((transtibial OR trans-tibial OR trans tibial OR below knee OR bka OR tta OR Leg[Mesh] OR leg OR legs OR lower limb OR lower limbs OR lower extremity OR lower extremit* OR "Lower Extremity"[Mesh])))

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MethodsSecondary Search Term SetsProsthetic search terms:

• air limb OR air splint OR air* OR airleg OR Amputation Stumps[Mesh] OR artificial limb OR bandage OR bandag* OR Bandages[Mesh] OR contracture* OR "Contracture"[Mesh] OR cost OR doff [tiab] OR donning [tiab] OR don [tiab] OR soft dress* [tiab] OR econom* [tiab] OR Economics[Mesh] OR elastic* OR fit OR fitt* OR liner OR lined OR lining OR piston* [tiab] OR pneumatic OR prognos* OR "Prognosis"[Mesh] OR “range of motion” OR Range of Motion, Articular[Mesh] OR rigid OR rom OR sock OR socket OR stump* OR suspension*

Rehabilitation search terms:

• "Activities of Daily Living"[Mesh] OR adl OR ambulate* OR ambulation OR athletic OR balance OR contracture* OR "Contracture"[Mesh] OR cost OR econom* OR Economics[Mesh] OR fall OR mobility OR mobilize OR physical therapy OR prognosis OR “range of motion” OR Range of Motion, Articular[Mesh] OR recreation OR Recreation[Mesh] OR rehabilitation OR "Rehabilitation"[Mesh] OR Resistance Training[Mesh] OR rom OR safety OR sport OR Sports[Mesh] OR stage OR strength* OR stumble OR therapy OR train* OR training

Medical search terms:

• bone bridge OR bone spur OR community ambulat* OR contracture* OR "Contracture"[Mesh] OR cost OR econom* OR Economics[Mesh] OR ertl [tiab] OR heterotopic ossification OR household ambulat* OR infection OR "K Level" OR Medicare Functional Classification Level OR Ossification, Heterotopic[Mesh] OR osteomyoplast* OR "Osteophyte"[Mesh] OR pain OR phantom OR "Phantom Limb"[Mesh] OR postoperative OR prognosis OR "range of motion" OR Range of Motion, Articular[Mesh] OR rom OR surgery OR surgical OR therapeutic ambulat* OR variable cadence

Methods• Search Conducted: Mar 11-19, 2013

• Data bases searched:1. Pubmed (1947-present)

2. CINAHL (1981-present)

3. EMBASE (1974-present)

4. RECAL Legacy (1900s-2007)

5. Web of Science (1900-present)

6. Google Scholar (early 1900s-present)

7. Cochrane Database of Systematic Reviews (1992-present)

8. Cochrane Clinical Trials Registry (1992-present)

9. PMC-NIH Research Publication Database (2000-present)

• Date limits: 1997 (Jan 1) - 2012 (Dec 31)

• Additionally, selected articles manually searched for potential references missed in the electronic search

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MethodsArticle Screening:

• References exported to EndNote bibliographic citation software

• Articles divided equally b/t 4 reviewers

• assigned 1° & 2° reviewers

• 2 reviewers independently screened references– per inclusion/exclusion criteria

• classified as either: – Pertinent

– Not pertinent

– Uncertain pertinence

• Full-text articles reviewed for all citations classified as pertinent or uncertain pertinence

• Disagreement of uncertain pertinence resolved by discussion at weekly follow up meetings with the 2 other reviewers

• Review & discussion of full-text articles led to group consensus & ultimate inclusion/exclusion

Methods• Following screening, full-text articles sorted by

specific pertinence in ≥1 identified subtopics

• scope of topics categorized following screening– i.e. grouping sockets + liners into a group called

“interface”

– based on articles that made it through screening

• healthcare economics for each of the topics will be assessed another time– ongoing

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Methods• Search completed articles input to endnote

• prior to scoring study quality & bias…

• Exclusion Criteria:– Endnote vX6 search of articles for the following terms used as

filters to eliminate references outside the scope of interest:

1. Case studies or reports

2. Foreign language(i.e. non-English language)

3. Developing countries

4. Modeling/fine element analysis studies& other non-subject studies

5. Pilot studies

6. Preliminary studies

7. Theses or dissertations

8. Pediatric studies

9. Technical notes

10. Retrospective

11. Economic

12. Observational/survey

Methods

• Inclusion Criteria:1. High quality study

2. Intervention study or Systematic Review

3. Transtibial management by means of intervention within a key interest area

4. Published within the timeline

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MethodsPEDro Scale (Intervention Studies/Comparative Efficacy/Clinical Trials)• methodologic quality (for safety and energy efficiency topics)• fair to good reliability for application in rehabilitative clinical trials• results in a 0-10 score

– higher scores = higher methodologic quality– 11 criteria– 1st criterion not scored– To receive a point in each of the remaining 10 criteria, it must be clearly stated in the study resulting in a ‘yes’ answer

for presence of that item, and the awarding of one (1) point. If an item is not clearly stated, it receives a ‘no’ answer and receives no point for that criterion

– ≥6/10 = high methodologic quality– ≤ 5/10 = low methodologic quality

Sign 50 (2 Checklists: Intervention Studies/RCT and Systematic Reviews)• 1) assess internal validity, 2) degree of bias 3) extract useful data from studies (safety and energy

efficiency topics)• The risk of bias is:

– Low- All/most criteria from internal validity assessment satisfied. Study conclusions not likely altered if methods changed.

– Moderate- Some criteria satisfied. Study conclusions not likely altered if methods changed.– High- Few/none of the criteria satisfied. Study conclusions likely or very likely altered if methods changed.

CEBM• Grades literature from A to D• Following assessment of methodologic quality and risk of bias, the level and grade of evidence was

determined by using the model designed by the Center for Evidence Based Medicine.

Effect Size• Cohen effect sizes: small (0.2), medium (0.5), large (0.8)

Eliminated after Endnote filtering

Results

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Results

Records identified through database searching

(n = 23,142)

Screening

Included

Eligibility

Iden

tification

Eliminated: duplicates (multi‐copy), foreign language, modeling, pediatric (n = 22,516)

Title & Abstracts screened(n =626)

Records excluded(n = 491)

Full‐text articles assessed for eligibility(n = 135)

Full‐text articles excluded(n = 103)

Studies included in qualitative synthesis

(n =32)

Intervention Studies (n = 26)

Systematic Reviews(n=6)

Interface (n = 5)

Pylon (n = 5)

Post‐op Dressings (n = 5)

Feet (n = 7)

Alignment(n = 4)

Feet (n = 1)

Post‐op Dressings (n = 3)

Interface (n = 2)

=32 total

ResultsIntervention Studies

Author Year JournalPEDro Score/Item

Topic1 2 3 4 5 6 7 8 9 10 11 SUM

Grumillier 2008 J Biomech 1 1 0 1 0 0 0 1 1 1 1 6 alignBeyaert 2008 G&P 1 1 0 1 0 0 0 1 1 1 1 6 alignBoone 2012 JRRD 1 1 0 1 1 0 0 1 1 1 1 7 align

van Velzen 2005 POI 1 1 1 1 0 0 0 0 1 1 1 6 alignZmitrewicz 2006 APMR 1 1 0 1 1 0 0 1 1 1 1 7 feetPostema 1997 POI 1 1 0 1 1 1 0 1 0 1 1 7 feetYack 1999 JPO 0 1 0 1 0 0 0 1 1 1 1 6 feetHsu 1999 JOSPT 1 1 0 1 0 0 0 1 1 1 1 6 feet

Postema 1997 POI 0 1 0 0 1 0 1 1 1 1 1 7 feetUnderwood 2004 Clin Biomech 1 1 0 1 0 0 0 1 1 1 1 6 feet

Perry 1997 IEEE 0 1 0 1 0 0 0 1 1 1 1 6 feet Johannesson 2008 ACTA Orth 1 1 1 0 1 1 1 0 0 1 1 7 post‐op dressings

Graf 2003 POI 1 1 0 1 0 0 0 1 1 1 1 6 post‐op dressingsVigier 1999 APMR 1 1 0 1 0 0 0 1 1 1 1 6 post‐op dressings

Woodburn 2004 POI 1 1 1 1 0 1 0 0 0 1 1 7 post‐op dressingsMazari 2010 J of Vasc Surg 1 1 1 1 0 0 0 1 1 1 1 7 post‐op dressingsKlute 2006 APMR 1 1 0 1 1 0 0 0 1 1 1 6 pylonJones 2006 Clin Biom 0 1 0 1 1 0 0 1 1 1 1 7 pylonLee 2006 IEEE 0 1 0 1 1 0 0 1 1 1 1 7 pylonBerge 2005 JRRD 1 1 0 1 1 0 0 1 0 1 1 7 pylonSegal 2010 Jrnl Biomech 1 1 0 1 1 0 0 1 1 1 1 7 pylonBeil 2002 JRRD 0 1 0 1 0 0 0 1 1 1 1 6 socketSelles 2005 APMR 1 1 1 1 0 0 0 0 0 1 1 5 socketKlute 2011 APMR 1 1 1 1 0 0 0 0 1 1 1 6 socket

Traballesi 2012 Eur J Rehab 1 1 1 1 0 0 0 1 1 1 1 7 socketColeman 2004 JRRD 1 1 0 1 0 0 0 1 1 1 1 7 liner

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Topic1 2 3 4 5 6 7 8 9 10 11 SUM








All high quality TTA intervention studies:

1. Randomized (item 2)

2. Presented comparisons for at least 1 outcome (item 10)

3. Presented point & variance measures (item 11)



Topic1 2 3 4 5 6 7 8 9 10 11 SUM








Less than half of high quality TTA studies

1. Concealed allocation to intervention (item 3)

– 7/26 studies

2. Blinded subjects (item 5)– 10/26 studies

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Topic1 2 3 4 5 6 7 8 9 10 11 SUM








ONLY

1. 3 studies blinded the clinician (item 6)

2. 2 studies blinded raters (item 7)

Results• Bias Risk (Sign 50 checklist): Intervention Studies

• Collectively– 4/26 studies High

• 3 interface

• 1 post op dressing

• High attrition (mean 33% vs mean 12% for the total sample)

– 20/26 studies Moderate

– 2/26 studies Low• 1 each: post-op dressing & pylon

• Interestingly, the post-op study had 38% attrition

• Bias Risk collectively: – 100% had: research question & randomization

– Small # points lost for non-validated outcomes

– Most points lost for: blinding, concealment, ITT

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ResultsSystematic Reviews

Author Year Journal Category # Databases Bias RiskHofstad 2004 Cochrane Foot Ankle 6 LOWNawjin 2005 POI stump mgt post amp 2 LOW

Sanders 2011 JRRD Limb Volume 4 LOWSmith 2003 JRRD Post op mgt 1 MODERATEBaars 2005 POI Liners 5 MODERATEKlute 2010 POI Liners 2 MODERATE

1. 6 Systematic Reviews Included

2. Bias Risk: (as scored by Sign 50) 3 Low & 3 Moderate

3. # databases searched 1-6

4. No meta-analyses. Dissimilarity of data/methods.

1 meta analysis found but did not support one of the identified areas

Adaptation strategies

Results & Discussion

Feet/Ankle

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Feet & Ankles

• Single Axis Foot (Perry et al.)– Sagittal hinge accelerates plantar & dorsiflexion while balanced on the heel

– Otto Bock Lager (Single Axis; conventional) foot scored lower in fatigue & walking speed vs.(Postema et al.):

• Otto Bock Multi-axial (conventional) foot and

• 2 ESARs (Otto Bock Dynamic Pro & Hanger Quantum) feet

– Ankle ROM w/ Otto Bock Lager (SA) larger than other feet due to ankle mechanism (Postema et al.)

•

• Multi-axial feet & ankles (Zmitrewics et al. Postema et al.)– MA ankles added to prosthetic feet improves (Zmitrewics et al.):

• residual limb propulsive impulses

• thus leg load symmetry

• preference for feet that improve symmetry

– MA foot less fatiguing & ↑d walk speed over SA foot (Postema et al.)

– Older, dysvascular TTAs may not benefit from ↑d ankle flexibility (Zmitrewics et al.):

– Preference for MA ankles vs. same feet (SACH & flexible keel) w/out ankles


Bias Risk1 2 3 4 5 6 7 8 9 10 11 SUM

Zmitrewicz 2006 APMR 1 1 0 1 1 0 0 1 1 1 1 7 ModerateUnderwood 2004 Clin Biomech 1 1 0 1 0 0 0 1 1 1 1 6 Moderate

Hsu 1999 JOSPT 1 1 0 1 0 0 0 1 1 1 1 6 ModerateYack 1999 JPO 0 1 0 1 0 0 0 1 1 1 1 6 ModeratePerry 1997 IEEE 0 1 0 1 0 0 0 1 1 1 1 6 Moderate

Postema 1997 POI 1 1 0 1 1 1 0 1 0 1 1 7 ModeratePostema 1997 POI 0 1 0 0 1 0 1 1 1 1 1 7 Moderate

Feet & Ankles• Energy Storing Feet

– General:

• Unilateral TTAs use amputated side hip (instead of knee) strategy to ascend stairs– ↑d hip extensor demand; ↑d hip work req’d w/ SACH means ESR feet offer advantage for TTAs who

walk stairs regularly

• Older, dysvascular amputees may not benefit from ↑d energy storage & return

– Flex foot (Vari-flex) (Systematic Review: Hofstad et al.): compared to SACH, flex foot (trend) ↑ stride length & ↓energy cost

– Seattle Lightfoot & Flex Foot designs (Perry et al.):

• Stiffer & conversely prolong unstable heel only support

• delays forefoot contact & ↓s fwd progression in stance (weight acceptance)

– Flex Walk

• improves prosthetic foot walking propulsion & stability w/ minimal compensations at remaining joints

– Dynamic Pro (Otto Bock) Quantum (Hanger) (Postema et al.)

• ↓d fatigue & improved walk speed vs. SA foot (Otto Bock Lager)

• no clear biomechanical diff b/t ESAR vs. 2 conventional feet (Otto Bock Lager-SA & Multi-axial foot)

• Non-significant diff in mechanical ESAR, determined from ankle power; unlikely noticeable in normal walking

– Re-Flex VSP

• positively influences energy cost, gait efficiency & relative exercise intensity vs. SACH & Flex Foot in walking & running


Bias Risk1 2 3 4 5 6 7 8 9 10 11 SUM

Zmitrewicz 2006 APMR 1 1 0 1 1 0 0 1 1 1 1 7 ModerateUnderwood 2004 Clin Biomech 1 1 0 1 0 0 0 1 1 1 1 6 Moderate

Hsu 1999 JOSPT 1 1 0 1 0 0 0 1 1 1 1 6 ModerateYack 1999 JPO 0 1 0 1 0 0 0 1 1 1 1 6 ModeratePerry 1997 IEEE 0 1 0 1 0 0 0 1 1 1 1 6 Moderate

Postema 1997 POI 1 1 0 1 1 1 0 1 0 1 1 7 ModeratePostema 1997 POI 0 1 0 0 1 0 1 1 1 1 1 7 Moderate

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Pylons

Pylons

• Compared w/ typical rigid pylon, in unilateral TTAs, telescopic/torsional pylons were equally effective in terms of:

– step down task biomechanics (Jones et al.)

– activity level & duration (Klute et al.)

– spatiotemporal/biomechanical gait & subjective measures (Berge et al.)

– stability & walking speed when tested in linear and circular walking (Segal et al.)

• Elliptical vs. Circular Shank Monolimbs (Lee et al.)– More flexible ES (elliptical shank) monolimb significantly ↓d sound

limb vGRF at early stance phase & prosthetic limb at terminal stance.

– Most subjects reported ↑d comfort w/ their current prostheses, but welcomed lighter weight from either monolimb & could perceive ↑d flexibility w/ ES monolimb

– Comparing ES w/ CS (circular shank) monolimb, all subjects perceived ES ↑d comfort


Topic1 2 3 4 5 6 7 8 9 10 11 SUM

Segal 2010 J Biomech 1 1 0 1 1 0 0 1 1 1 1 7 LowJones 2006 Clin Biom 0 1 0 1 1 0 0 1 1 1 1 7 ModerateKlute 2006 APMR 1 1 0 1 1 0 0 0 1 1 1 6 ModerateLee 2006 IEEE 0 1 0 1 1 0 0 1 1 1 1 7 Moderate

Berge 2005 JRRD 1 1 0 1 1 0 0 1 0 1 1 7 Moderate

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Alignment

AlignmentPerception of malalignment:

• Subjects perceived extreme coronal & sagittal malalignments (Boone et al.)

• Instrumentation may be useful to detect minor malalignments– particularly in sagittal plane

Known effects of malalignment:

• In TTA, prosthetic malalignment into internal rotation vs. initial alignment– ↓ comfort

– Total hip work ↑d (Grumillier et al.)• potential compensatory strategy 2° ↓d prosthetic shock absorption

– Sound limb experience max knee flexion & ↑ total work vs prosthetic & control legs (Beyaert et al.)

– does not alter prosthetic side knee kinetics

• Step duration ↓d w/ 15° malalignment into dorsiflexion (van Velzen et al.)

• Medial force ↓d in late stance w/ malalignment into: (van Velzen et al.)– Varus vs. Valgus

– Internal rotation vs. External rotation


Bias Risk1 2 3 4 5 6 7 8 9 10 11 SUM

Boone 2012 JRRD 1 1 0 1 1 0 0 1 1 1 1 7 ModerateGrumillier 2008 J Biomech 1 1 0 1 0 0 0 1 1 1 1 6 ModerateBeyaert 2008 G&P 1 1 0 1 0 0 0 1 1 1 1 6 Moderate

van Velzen 2005 POI 1 1 1 1 0 0 0 0 1 1 1 6 Moderate

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Post-Operative Care:

Dressings &

Early Walking Aids


Bias Risk1 2 3 4 5 6 7 8 9 10 11 SUM

Mazari 2010 J Vasc Surg 1 1 1 1 0 0 0 1 1 1 1 7 HighJohannesson 2008 ACTA Orth 1 1 1 0 1 1 1 0 0 1 1 7 Moderate

Woodburn 2004 POI 1 1 1 1 0 1 0 0 0 1 1 7 LowGraf 2003 POI 1 1 0 1 0 0 0 1 1 1 1 6 Moderate

Vigier 1999 APMR 1 1 0 1 0 0 0 1 1 1 1 6 Moderate

Early Walking Aids (Mazari, et al.)• No difference in clinical & QOL outcomes b/t articulated vs. non-

articulated walk aids in TTA rehab

• (SR: Sanders et al.) early weight bearing ↓ post-op edema (Low level evidence)

Results

RRDs • Polymer elastic gel socks vs non-elastic socks, in conjunction w/ RRD

can influence stump volume ↓ in first 3 wks post-op (Graf, et al.)

• Results similar from VAS & plaster RRD post-op dressing types (Johannesson, et al.)

• Plaster RRD vs soft dressing bandage did not ↓ time to prosthetic fitting or infection rate (Woodburn, et al.)

• Plaster RRD ↓d healing time by 25 days & hospital stay by 30 days vselastic bandage (Vigier, et al.)

• (SR: Nawjin et al.) trend favoring rigid & semi-rigid dressings to achieve stump healing & volume reduction in vascular TTA patients

• (SR: Sanders et al.) rigid & semi-rigid dressings control post-op edema better than soft dressings in TTA patients (Moderate evidence)

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Interface:

Socket, Liner &

VASS


Topic1 2 3 4 5 6 7 8 9 10 11 SUM

Traballesi 2012 Eur J Rehab 1 1 1 1 0 0 0 1 1 1 1 7 HighKlute 2011 APMR 1 1 1 1 0 0 0 0 1 1 1 6 HighSelles 2005 APMR 1 1 1 1 0 0 0 0 0 1 1 6 High

Coleman 2004 JRRD 1 1 0 1 0 0 0 1 1 1 1 7 ModerateBeil 2002 JRRD 0 1 0 1 0 0 0 1 1 1 1 6 Moderate

ResultsInterface• Socket Design

– PTB & TSB similar in patient satisfaction, gait & ADLs

(Selles, et al.)

– TSB ↑material cost; ↓fab time (Selles, et al.)

– Pelite improved preference & ambulatory activity vs Alpha liner (Coleman, et al.)

– (SR: Baars et al.) indication liner use improves: suspension, walking performance (i.e. distance, walk aid dependence). Unclear if skin problems caused or solved by liners.

– (SR: Klute et al.) indication liner use distributed load & ↓ pain. Prescription practice not well supported by literature.

• Vacuum Assisted Suspension (VAS)

– improved fitting time into prosthesis vs TSB in subjects post op or w/ ulcerations in definitive (Traballessi,et al.)

– ↓ step count, ↑ fab time (# check sockets) ↓ preference, but ↓ pistoning (Klute, et al.)

– ↓ positive pressure in stance but ↑ negative pressure in swing (Beil, et al.)

– (SR: Sanders et al.) evidence lacking to support the idea that volume control sockets control/adapt to limb condition.

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Results

Limitations• Using only high quality evidence could limit:

– Quantity of evidence

– Consistency of evidence

• Grading scales– Disagreement on best instrument & process

– We chose a reliable, internationally recognized tool

• Searching such a broad topic forces stringent limits (i.e. quality)– May be value in more focused search to ↑ quantity

– i.e. instead of 6/10 PEDro, maybe 4/10 to ↑ article count

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ConclusionsLevel Therapy/Prevention, Aetiology/Harm

1a SR (with homogeneity*) of RCTs1b Individual RCT (with narrow Confidence Interval‡)1c All or none§2a SR (with homogeneity*) of cohort studies

2bIndividual cohort study (including low quality RCT;

e.g., <80% follow-up)2c "Outcomes" Research; Ecological studies3a SR (with homogeneity*) of case-control studies3b Individual Case-Control Study

4Case-series (and poor quality cohort

and case-control studies§§)

5Expert opinion without explicit critical appraisal, or based on

physiology, bench research or "first principles"

Most Evidence Statements supported by level 1 studies.

High quality studies (≥6/10 PEDro)

Grade of Recommendation:A consistent level 1 studies B consistent level 2 or 3 studies or extrapolations from level 1 studiesC level 4 studies or extrapolations from level 2 or 3 studies D level 5 evidence or troublingly inconsistent or inconclusive studies of any level









A small # Evidence Statements supported by

consistent level 1 studies.

High quality studies (≥6/10 PEDro); EXAMPLE…

Grade of Recommendation:A consistent level 1 studies B consistent level 2 or 3 studies or extrapolations from level 1 studiesC level 4 studies or extrapolations from level 2 or 3 studies D level 5 evidence or troublingly inconsistent or inconclusive studies of any level

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Conclusions

RRDs• Plaster RRD ↓d healing time by 25 days & hospital stay by 30 days

vs elastic bandage (Vigier, et al.)

• (SR: Nawjin et al.) trend favoring rigid & semi-rigid dressings to achieve stump healing & volume reduction in vascular TTA patients

• (SR: Sanders et al.) rigid & semi-rigid dressings control post-op edema better than soft dressings in TTA patients (Moderate evidence)









A small # Evidence Statements that have disagreement

consistent level 1 studies.

High quality studies (≥6/10 PEDro); EXAMPLE:Grade of Recommendation:

A consistent level 1 studies B consistent level 2 or 3 studies or extrapolations from level 1 studiesC level 4 studies or extrapolations from level 2 or 3 studies D level 5 evidence or troublingly inconsistent or inconclusive studies of any level

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Interface• Socket Design

– PTB & TSB similar in patient satisfaction, gait & ADLs

(Selles, et al.)

– TSB ↑material cost; ↓fab time (Selles, et al.)

– Pelite improved preference & ambulatory activity vs Alpha liner (Coleman, et al.)

– (SR: Baars et al.) indication liner use improves: suspension, walking performance (i.e. distance, walk aid dependence). Unclear if skin problems caused or solved by liners.

– (SR: Klute et al.) indication liner use distributed load & ↓ pain. Prescription practice not well supported by literature.

• Translation: – 1 trial equivalent

– 2SR support liners

– 1 trial support pelite

• CEBM: “Troubling disagreement”

Conclusions

Conclusion

• Study Quality– Not terribly difficult to improve intervention study

quality by:• Blinding raters from intervention

• Assuring baseline similarity of subjects

• Follow up with subjects (prevent attrition)

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Future/Ongoing Work• Economics search/evaluation ongoing

• AOPA work group convening in 1 month to review

• Eventual publication

• Acknowledgement: supported by a grant from AOPA. Opinions are those of the authors.

Questions

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References

• Throughout presentation

aopa lit review 2013.ppt - american orthotic and ... · pdf file• medicare reimbursed...

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