PROFITS in short (1) presentatie NPI_ 2016... · STRUCTURAL AND MULTI-NETWORK ASSESSMENT OF...

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PROFITS A CLINICAL INFRASTRUCTURE FOR

STRUCTURAL AND MULTI- NETWORK

ASSESSMENT OF DETERMINANTS & MODULATORS OF FUNCTIONAL

OUTCOME AFTER STROKE

LeidenDelft

Rotterdam

Amsterdam

Twente

Nijmegen

• A longitudinal observational cohort (n=160).

• 0-26 weeks post- stroke

• Evolving in a clinical infrastructure

• Of standardized prognosis, monitoring and outcomeassessment of motor recovery post- stroke

PROFITS in short (1)

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• A longitudinal observational cohort (n=160).

• 0-26 weeks post- stroke

• Evolving in a clinical infrastructure

• Of standardized prognosis, monitoring and outcomeassessment of motor recovery post- stroke

PROFITS in short (1)

• Connect between acute phase and rehab phase.

– Effects of interventions in the acute phase ?

– Effects of interventions in the rehab phase ?

– Prediction rules for planning of rehab.

• As a basis for network care.

– Transport of information in the chain

• Integrating clinical care with research- development

Why PROFITS ?

3

Acu

te c

are

ACUTE PHASECHRONIC

PHASE

SUB

ACUTE

Prediction

Optimisation

Home

Acute

Rehab phase

Chronic phase

Strokeunit

Rehabcenter

Acute phase

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• Modified ranking scale:

– 0 = goed

– 6= dood.

• Barthel Index

• NIHSS score

MrClean, primary outcome

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STRONG TECHNOLOGICAL PUSH

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Left/right 2 1

Dominant side affected 19 15

476

Figure 3 Change in FMA-UE as compared to baseline during the course of study - a comparison between 477

conventional (control) and robotic therapy groups (ARMin); Error bars are standard deviations. 478

479

Table 3 F-ratios,significance levels, estimated marginal means, and confidence intervals for primary and 480

secondary outcomes. CI: confidence interval; FMA-UE: Fugl-Meyer Assessment (upper extremity motor 481

function); WMFT: Wolf Motor Function Test: MAL-QOM: Motor Activity Log, quality of movement; SIS = Stroke 482

Impact Scale, mAS = modified Ashworth Scale; GAS = Goal Attainment Scale. 483

group effect

F-ratio p value estimated marginal means CI

FMA-UE 4·2 ·041 0·78 0·03 to 1.53

WMFT time 1·4 ·173 2·02 -0·90 to 4·93

WMFT function 1·6 ·212 -0·37 -0·10 to 0·021

SIS total 3·6 ·059 1·42 -0·05 to 2·91

SIS physical domain 0·8 ·387 0·76 -0·96 to 2·47

BUT ADDED VALUE NOT YET PROVEN…

Kwakkel et al. 2008, Klamroth-Marganska et al. 2014, Kwakkel & Meskers, Lancet Neurology 2015.

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• Proper selection of patients?

• Proper timing of assessment?

• Target disease specific mechanisms?

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Left/right 2 1

Dominant side affected 19 15

476

Figure 3 Change in FMA-UE as compared to baseline during the course of study - a comparison between 477

conventional (control) and robotic therapy groups (ARMin); Error bars are standard deviations. 478

479

Table 3 F-ratios,significance levels, estimated marginal means, and confidence intervals for primary and 480

secondary outcomes. CI: confidence interval; FMA-UE: Fugl-Meyer Assessment (upper extremity motor 481

function); WMFT: Wolf Motor Function Test: MAL-QOM: Motor Activity Log, quality of movement; SIS = Stroke 482

Impact Scale, mAS = modified Ashworth Scale; GAS = Goal Attainment Scale. 483

group effect

F-ratio p value estimated marginal means CI

FMA-UE 4·2 ·041 0·78 0·03 to 1.53

WMFT time 1·4 ·173 2·02 -0·90 to 4·93

WMFT function 1·6 ·212 -0·37 -0·10 to 0·021

SIS total 3·6 ·059 1·42 -0·05 to 2·91

SIS physical domain 0·8 ·387 0·76 -0·96 to 2·47

]

INDIVIDUAL RECOVERY PATTERNS

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In first ever ischemic MCA- strokeDeterministic patterns of upper limb functionalrecovery in time (Kwakkel et al. Lancet 1999, Kwakkel et al. Stroke,

2006).P

robability for

achie

vin

g

dexte

rity

aft

er

MC

A s

troke

0

10

20

30

40

50

60

70

80

90

100

1 2 3 4 5 6 7 8 9 10

weeks

0

10

20

30

40

50

60

70

80

90

100

<72h 5d 1 2 3 4 5 6 7 8 9 10

Weeks post stroke

Good prognosis

Poor prognosis

Nijland et al, Stroke. 2010;41:745-50 Stinear et al, Lancet Neurol 2010; Dec;9(12):1228-32.De EPOS cohortstudie

SAFE-model

<72 hours

Probability (%) ARAT ≥ 10 points at 6 months post stroke (N=188)

FUNCTIONAL OUTCOME CAN BE PREDICTED

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Stroke: the 70% recovery rule

Winters et al. 2015 NNR

Kwakkel et al. NNR 2016

Explicit-stroke

S

NS

9

Restitution (spontaneous) Substitution

+Neurological

recovery

‘activities’

Kwakkel et al, Rest. Neurology & Neuroscience 2004;22:281-299

Buma et al, Rest Neurol Neuroscience 2013; 31(6):707-722)

Compensational

behavior

?

• Can we improve current prediction models of functionalrecovery post stroke in terms of restitution andcompensation?

– Do they hold in patients other than first ever MCA stroke? (recurrent stroke, bleeds, co-morbidity)?

– Can we identify the non- fitters?– Can we improve individual predictability?

PROFITS Research questions

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Acute Phase Rehab. phase

PredictionFunctional outcome

CLINICAL INFRASTRUCTURE

Chronic phase

Acute Phase Chronic phase

PredictionFunctional outcome

• Phenotype

• Clinimetry

• EEG

CLINICAL INFRASTRUCTURE

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Acute Phase Chronic phase

PredictionFunctional outcome

• Phenotype

• Clinimetry

• EEG

CLINICAL INFRASTRUCTURE

]

Acu

te c

are

HIGH PRECISION PROFILING COHORT

FUNCTIONALOUTCOME

PREDICTION

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+ +

References+

· Berkheimer+et+al.,+NEJM+2015;+372:11=20.+

· Nijland+et+al,+Stroke.+2010;+41:745=50;+

· Kwakkel+et+al.,+Neurorehabil+Neural+Repair+2016;+Jan+7.+

· Kwakkel+&+Meskers,+Lancet+Neurol.+2014;+13:132=3+

· Kwakkel+et+al.+Lancet+1999.+

· Kwakkel+et+al.+Stroke+2006.+

· Prabhakaran+et+al.,+Neurorehabil+Neural+Repair+2008;+22:64=71.+

· Stinear+et+al,+Lancet+Neurol+2010;+9:1228=32.+

· Winters+et+al.+Stroke+2016.+++Measurement+schemes.++I.+PROFITS+CORE.++

+++

II.+PROFITS=+FULL+++

+

+

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Clinimetrie- NIHSS- Fugl meyer- Trunk control- FAC- MI- Timed Balance Test- Barthel- MOCA

Uitkomst- Fugl Meyer BE- Fugl Meyer OE

- ARAT- 10 meter looptest

Type patient- Leeftijd/geslacht- Type stroken- Trombolyse?- Comorbiditeit- Risicofactoren- Complicaties

ACUTE FASE-PREDICTIE

FOLLOW-UP/HERSTEL

Clinimetrie- NIHSS- Fugl meyer- Trunk control- FAC- MI- Timed Balance Test- Barthel- MOCA

Uitkomst- Fugl Meyer BE- Fugl Meyer OE

- ARAT- 10 meter looptest

Type patient- Leeftijd/geslacht- Type stroken- Trombolyse?- Comorbiditeit- Risicofactoren- Complicaties

ACUTE FASE-PREDICTIE

FOLLOW-UP/HERSTEL

Restitutie

Compensatie

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Rehabcenter

Strokeunit

Nursinghome

Strokeunit

Nursinghome

Rehabcenter

Home

“Brain Van”

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Project support

Local assessment

Effo

rt

Time

Acute Phase Chronic phase

PredictionFunctional outcome

WEB BASED ICT SOLUTION

Web-baseddatabase

INDIVIDUALIZEDPREDCTION MODELS

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PROFITS APPROACH

Routine outcome measurements: Win-Win for clinical care and research

PROFITS SHOULD CREATE VALUE FOR

Treatment of individual patients

At the level of a organization/hospital

For research and development

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Create data on health care outcomes

AIMS AND STARTING POINTS

PROFITS

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HOW CAN IT HELP RESEARCH?

Research and development

Cohort studies, for example to develop clinical prediction models

Using practice variation for comparative effectiveness

Add-on studies:

Diagnostic and clinimetric

Randomized controlled trials

Etcetera

Rehabcenter

Strokeunit

Nursinghome

Strokeunit

Nursinghome

Rehabcenter

Home

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ICT INFRASTRUCTURE

EXISTING GEMSTRACKER APPLICATION

Dupuytren surgeryN=±2200

Thumb base OA n=±2000

Carpal tunnel syndromn=±4000

2011-present:

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EXISTING GEMSTRACKER APPLICATION

Combination of:

Patient-reported outcome

measures (PROMS)

Clinical reported outcome

measures (CROMS)

EXAMPLE USE CASE

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Example use case 2

GEMSTRACKER DATABASE

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23

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25

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STAPSGEWIJS

Klinimetrie coreset is gedefinieerd

Training van assessoren

Dataverzameling in PROFITS onderzoekcohort

Dataverzameling in reguliere zorg

Clinimetrie is standaardzorg

Clinimetrie over zorgketen

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Project support

Local assessment

Effo

rt

Time

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A. Andringa MScDr. C.G.M. Meskers MDDr. E.E.H. Van WegenProf dr. G. Kwakkel

Prof dr F.C.T van der Helm

Dr. R.W. SellesDr. J.B.J. Bussmann

Prof dr. G. Ribbers MDDr. J. Slaman

Dr. L. Aerden MD

MEER WETEN OF MEE DOEN?

Neem contact op met: Carel Meskers, Ruud Selles of Carel Meskers

Wij helpen graag met verdure afstemming intern op jullie afdeling, oamet de neurologen

C.meskers@vumc.nl

R.selles@erasmusmc.nl

G.Kwakkel@vumc.nl