• No results found

University of Groningen Assessment of malnutrition in patients with head and neck cancer: a multidimensional approach Sealy, Martine Jane

N/A
N/A
Protected

Academic year: 2021

Share "University of Groningen Assessment of malnutrition in patients with head and neck cancer: a multidimensional approach Sealy, Martine Jane"

Copied!
39
0
0

Bezig met laden.... (Bekijk nu de volledige tekst)

Hele tekst

(1)

Assessment of malnutrition in patients with head and neck cancer: a multidimensional

approach

Sealy, Martine Jane

IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below.

Document Version

Publisher's PDF, also known as Version of record

Publication date: 2019

Link to publication in University of Groningen/UMCG research database

Citation for published version (APA):

Sealy, M. J. (2019). Assessment of malnutrition in patients with head and neck cancer: a multidimensional approach.

Copyright

Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).

Take-down policy

If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.

Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum.

(2)



&KDSWHU7UDQVODWLRQDQGFXOWXUDODGDSWDWLRQRIWKHVFRUHG

3DWLHQW*HQHUDWHG6XEMHFWLYH*OREDO$VVHVVPHQW 3*6*$ 

DQLQWHUGLVFLSOLQDU\QXWULWLRQDOLQVWUXPHQWDSSURSULDWHIRU'XWFK

FDQFHUSDWLHQWV

 &DQFHU1XUVLQJ    0DUWLQH-6HDO\ 8OULNHHaß )DLWK'2WWHU\ &HHV3YDQGHU6FKDQV -DQ/15RRGHQEXUJ Harriët Jager:LWWHQDDU   

(3)

 $EVWUDFW %DFNJURXQG7KH6FRUHG3DWLHQW*HQHUDWHG6XEMHFWLYH*OREDO$VVHVVPHQW 3*6*$ LVDQ LQVWUXPHQWWKDWHQDEOHVLQWHUGLVFLSOLQDU\DVVHVVPHQWRIPDOQXWULWLRQDQGLWVULVNIDFWRUVZKLFK LVQRWDYDLODEOHLQ'XWFK 2EMHFWLYH7UDQVODWLRQDQGFXOWXUDODGDSWLRQRIWKHRULJLQDO(QJOLVK3*6*$WRWKH'XWFK VHWWLQJ

0HWKRGV 7KH 6FRUHG 3*6*$ ZDV WUDQVODWHG DQG FXOWXUDOO\ DGDSWHG IROORZLQJ ,6325 SULQFLSOHV3HUFHLYHGFRQWHQWYDOLGLW\FRPSUHKHQVLELOLW\DQGGLIILFXOW\ZHUHH[SORUHGDPRQJD PXOWLGLVFLSOLQDU\ VDPSOH RI KHDOWKFDUH SURIHVVLRQDOV DQG WKHLU FDQFHU SDWLHQWV &RQWHQW YDOLGLW\FRPSUHKHQVLELOLW\DQGGLIILFXOW\ZHUHRSHUDWLRQDOL]HGE\FDOFXODWLQJLWHPDQGVFDOH LQGLFHV2QVFDOHOHYHOLQGLFHVRI0.90 were considered acceptable and indices of ≥0.90 ZHUHFRQVLGHUHGH[FHOOHQW

5HVXOWV&RQVHQVXVZDVUHDFKHGRQDQGGLIIHUHQFHVLQWKHIRUZDUGDQGEDFNWUDQVODWLRQV UHVSHFWLYHO\6FDOH&RQWHQW9DOLGLW\,QGH[ZDV6FDOH&RPSUHKHQVLELOLW\,QGH[ 6&, DQG 6FDOH'LIILFXOW\,QGH[ 6', RIWKHSDWLHQWJHQHUDWHGFRPSRQHQWRIWKH3*6*$ZHUH DQG  UHVSHFWLYHO\ 6&, DQG 6', RI WKH SURIHVVLRQDO FRPSRQHQW ZHUH  DQG  UHVSHFWLYHO\

&RQFOXVLRQV 7UDQVODWLRQ DQG FXOWXUDO DGDSWDWLRQ RI WKH 3*6*$ DFFRUGLQJ WR ,6325 SULQFLSOHVUHVXOWHGLQD'XWFKYHUVLRQWKDWPDLQWDLQHGSXUSRVHPHDQLQJDQGIRUPDWDQGKDV DFFHSWDEOHFRQWHQWYDOLGLW\1RZD'XWFKYHUVLRQRIWKH3*6*$LVDYDLODEOHWKDWLVFRQVLGHUHG FRPSUHKHQVLEOH DQG HDV\ E\ SDWLHQWV DQG FRPSUHKHQVLEOH DQG UHOHYDQW E\ SURIHVVLRQDOV

 +RZHYHU WKH SURIHVVLRQDO FRPSRQHQW ZDV FRQVLGHUHG GLIILFXOW E\ WKH 3*6*$ QDLYH KHDOWKFDUHSURIHVVLRQDOVZKLFKLQGLFDWHVDQHHGIRUWUDLQLQJRISURIHVVLRQDOV

,PSOLFDWLRQVIRU3UDFWLFH$VLPLODUV\VWHPDWLFDSSURDFKIRUIXWXUHWUDQVODWLRQVRIWKH3*6*$ LVUHFRPPHQGHGWRVDIHJXDUGFXOWXUDOHTXLYDOHQFH



,QWURGXFWLRQ

Malnutrition has been defined as “An acute, subacute or chronic state of nutrition, in which a FRPELQDWLRQRIYDU\LQJGHJUHHVRIRYHUQXWULWLRQRUXQGHUQXWULWLRQDQGLQIODPPDWRU\DFWLYLW\ has led to a change in body composition and diminished function”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

(4)

3

 $EVWUDFW %DFNJURXQG7KH6FRUHG3DWLHQW*HQHUDWHG6XEMHFWLYH*OREDO$VVHVVPHQW 3*6*$ LVDQ LQVWUXPHQWWKDWHQDEOHVLQWHUGLVFLSOLQDU\DVVHVVPHQWRIPDOQXWULWLRQDQGLWVULVNIDFWRUVZKLFK LVQRWDYDLODEOHLQ'XWFK 2EMHFWLYH7UDQVODWLRQDQGFXOWXUDODGDSWLRQRIWKHRULJLQDO(QJOLVK3*6*$WRWKH'XWFK VHWWLQJ

0HWKRGV 7KH 6FRUHG 3*6*$ ZDV WUDQVODWHG DQG FXOWXUDOO\ DGDSWHG IROORZLQJ ,6325 SULQFLSOHV3HUFHLYHGFRQWHQWYDOLGLW\FRPSUHKHQVLELOLW\DQGGLIILFXOW\ZHUHH[SORUHGDPRQJD PXOWLGLVFLSOLQDU\ VDPSOH RI KHDOWKFDUH SURIHVVLRQDOV DQG WKHLU FDQFHU SDWLHQWV &RQWHQW YDOLGLW\FRPSUHKHQVLELOLW\DQGGLIILFXOW\ZHUHRSHUDWLRQDOL]HGE\FDOFXODWLQJLWHPDQGVFDOH LQGLFHV2QVFDOHOHYHOLQGLFHVRI0.90 were considered acceptable and indices of ≥0.90 ZHUHFRQVLGHUHGH[FHOOHQW

5HVXOWV&RQVHQVXVZDVUHDFKHGRQDQGGLIIHUHQFHVLQWKHIRUZDUGDQGEDFNWUDQVODWLRQV UHVSHFWLYHO\6FDOH&RQWHQW9DOLGLW\,QGH[ZDV6FDOH&RPSUHKHQVLELOLW\,QGH[ 6&, DQG 6FDOH'LIILFXOW\,QGH[ 6', RIWKHSDWLHQWJHQHUDWHGFRPSRQHQWRIWKH3*6*$ZHUH DQG  UHVSHFWLYHO\ 6&, DQG 6', RI WKH SURIHVVLRQDO FRPSRQHQW ZHUH  DQG  UHVSHFWLYHO\

&RQFOXVLRQV 7UDQVODWLRQ DQG FXOWXUDO DGDSWDWLRQ RI WKH 3*6*$ DFFRUGLQJ WR ,6325 SULQFLSOHVUHVXOWHGLQD'XWFKYHUVLRQWKDWPDLQWDLQHGSXUSRVHPHDQLQJDQGIRUPDWDQGKDV DFFHSWDEOHFRQWHQWYDOLGLW\1RZD'XWFKYHUVLRQRIWKH3*6*$LVDYDLODEOHWKDWLVFRQVLGHUHG FRPSUHKHQVLEOH DQG HDV\ E\ SDWLHQWV DQG FRPSUHKHQVLEOH DQG UHOHYDQW E\ SURIHVVLRQDOV

 +RZHYHU WKH SURIHVVLRQDO FRPSRQHQW ZDV FRQVLGHUHG GLIILFXOW E\ WKH 3*6*$ QDLYH KHDOWKFDUHSURIHVVLRQDOVZKLFKLQGLFDWHVDQHHGIRUWUDLQLQJRISURIHVVLRQDOV

,PSOLFDWLRQVIRU3UDFWLFH$VLPLODUV\VWHPDWLFDSSURDFKIRUIXWXUHWUDQVODWLRQVRIWKH3*6*$ LVUHFRPPHQGHGWRVDIHJXDUGFXOWXUDOHTXLYDOHQFH



,QWURGXFWLRQ

Malnutrition has been defined as “An acute, subacute or chronic state of nutrition, in which a FRPELQDWLRQRIYDU\LQJGHJUHHVRIRYHUQXWULWLRQRUXQGHUQXWULWLRQDQGLQIODPPDWRU\DFWLYLW\ has led to a change in body composition and diminished function”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

(5)



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‘PGSGA’, reflects the extensive clinical and research interest in this instrument.

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ooperative Oncology Group (ECOG) performance status, converted to layman’s language. 7KHVHIRXU%R[HVZHUHGHVLJQHGWRUHIOHFWDSSUR[LPDWHO\RIWKHVFRUHIRUDQ\JLYHQ SDWLHQWDQGDUHRIILFLDOO\NQRZQDVWKH3*6*$6KRUW)RUP 3*6*$6) DWWLPHVUHIHUUHG WR LQ WKH OLWHUDWXUH DV WKH DEULGJHG 3*6*$ 7KH 3*6*$ 6) KDV EHHQ YDOLGDWHG DV DQ LQGHSHQGHQWVFUHHQLQJWRROIRUPDOQXWULWLRQDQGLWVULVNIDFWRUV

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

(6)

3



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‘PGSGA’, reflects the extensive clinical and research interest in this instrument.

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ooperative Oncology Group (ECOG) performance status, converted to layman’s language. 7KHVHIRXU%R[HVZHUHGHVLJQHGWRUHIOHFWDSSUR[LPDWHO\RIWKHVFRUHIRUDQ\JLYHQ SDWLHQWDQGDUHRIILFLDOO\NQRZQDVWKH3*6*$6KRUW)RUP 3*6*$6) DWWLPHVUHIHUUHG WR LQ WKH OLWHUDWXUH DV WKH DEULGJHG 3*6*$ 7KH 3*6*$ 6) KDV EHHQ YDOLGDWHG DV DQ LQGHSHQGHQWVFUHHQLQJWRROIRUPDOQXWULWLRQDQGLWVULVNIDFWRUV

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

(7)

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

,Q FRQWUDVW WR WKH FDWHJRULFDO DVVHVVPHQW WKH 3*6*$ QXPHULFDO VFRUH DOORZV WULDJH IRU LQWHUGLVFLSOLQDU\LQWHUYHQWLRQVDVZHOODVDPHDQVWRPRQLWRURXWFRPHVRIWKHVHLQWHUYHQWLRQV 7KHDGGLWLYHVFRUHLVXVHGWRJXLGHLQWHUGLVFLSOLQDU\LQWHUYHQWLRQVLQFOXGLQJSDWLHQWDQGFDUHU HGXFDWLRQ V\PSWRP PDQDJHPHQW LQFOXGLQJ SKDUPDFRORJLF LQWHUYHQWLRQ DQG QXWULWLRQDO LQWHUYHQWLRQ IRRGQXWULWLRQDOVXSSOHPHQWVHQWHUDORUSDUHQWHUDOQXWULWLRQ 

7ULDJHUHFRPPHQGDWLRQVEDVHGRQ3*6*$SRLQWVFRUHDUHDVIROORZV

1RLQWHUYHQWLRQUHTXLUHGDWWKLVWLPH5HDVVHVVPHQWRQURXWLQHDQGUHJXODUEDVLVGXULQJ WUHDWPHQW

 3DWLHQW  IDPLO\ HGXFDWLRQ E\ GLHWLWLDQ QXUVH RU RWKHU FOLQLFLDQ ZLWK SKDUPDFRORJLF LQWHUYHQWLRQDVLQGLFDWHGE\V\PSWRPVXUYH\ %R[ DQGODEYDOXHVDVDSSURSULDWH

5HTXLUHVLQWHUYHQWLRQE\GLHWLWLDQLQFRQMXQFWLRQZLWKQXUVHRUSK\VLFLDQDVLQGLFDWHGE\ V\PSWRPV %R[ 

≥ 9 Indicates a critical need for improved symptom management and/or nutrient intervention RSWLRQV

 5DWLRQDOHIRUWUDQVODWLRQDQGFXOWXUDODGDSWDWLRQ

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

(8)

3

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

,Q FRQWUDVW WR WKH FDWHJRULFDO DVVHVVPHQW WKH 3*6*$ QXPHULFDO VFRUH DOORZV WULDJH IRU LQWHUGLVFLSOLQDU\LQWHUYHQWLRQVDVZHOODVDPHDQVWRPRQLWRURXWFRPHVRIWKHVHLQWHUYHQWLRQV 7KHDGGLWLYHVFRUHLVXVHGWRJXLGHLQWHUGLVFLSOLQDU\LQWHUYHQWLRQVLQFOXGLQJSDWLHQWDQGFDUHU HGXFDWLRQ V\PSWRP PDQDJHPHQW LQFOXGLQJ SKDUPDFRORJLF LQWHUYHQWLRQ DQG QXWULWLRQDO LQWHUYHQWLRQ IRRGQXWULWLRQDOVXSSOHPHQWVHQWHUDORUSDUHQWHUDOQXWULWLRQ 

7ULDJHUHFRPPHQGDWLRQVEDVHGRQ3*6*$SRLQWVFRUHDUHDVIROORZV

1RLQWHUYHQWLRQUHTXLUHGDWWKLVWLPH5HDVVHVVPHQWRQURXWLQHDQGUHJXODUEDVLVGXULQJ WUHDWPHQW

 3DWLHQW  IDPLO\ HGXFDWLRQ E\ GLHWLWLDQ QXUVH RU RWKHU FOLQLFLDQ ZLWK SKDUPDFRORJLF LQWHUYHQWLRQDVLQGLFDWHGE\V\PSWRPVXUYH\ %R[ DQGODEYDOXHVDVDSSURSULDWH

5HTXLUHVLQWHUYHQWLRQE\GLHWLWLDQLQFRQMXQFWLRQZLWKQXUVHRUSK\VLFLDQDVLQGLFDWHGE\ V\PSWRPV %R[ 

≥ 9 Indicates a critical need for improved symptom management and/or nutrient intervention RSWLRQV

 5DWLRQDOHIRUWUDQVODWLRQDQGFXOWXUDODGDSWDWLRQ

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

(9)



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

(10)

3



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

(11)

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

6WHS)RUZDUGWUDQVODWLRQThe initiator of the project, further referred to as the ‘key country person’, provided the first forwaUGWUDQVODWLRQRIDODUJHSULQWYHUVLRQRIWKH3*SGA (©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

(12)

3

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

6WHS)RUZDUGWUDQVODWLRQThe initiator of the project, further referred to as the ‘key country person’, provided the first forwaUGWUDQVODWLRQRIDODUJHSULQWYHUVLRQRIWKH3*SGA (©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

(13)



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

&RQFHSW ,WHPV3DWLHQWJHQHUDWHGFRPSRQHQW ,WHPV3URIHVVLRQDOFRPSRQHQW

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

(14)

3



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

&RQFHSW ,WHPV3DWLHQWJHQHUDWHGFRPSRQHQW ,WHPV3URIHVVLRQDOFRPSRQHQW

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

(15)



DGDSWHGIRUWKLVVWXG\,QGLFHVIRULWHPFRPSUHKHQVLELOLW\ ,&, DQGLWHPGLIILFXOW\ ,',  ZHUHFDOFXODWHGDQGDYHUDJHGLQWRVFDOHFRPSUHKHQVLELOLW\LQGLFHV 6&, DQGVFDOHGLIILFXOW\ LQGLFHV 6', 

7KHIROORZLQJSURFHGXUHZDVXVHGWRFDOFXODWHDOOLWHPDQGVFDOHLQGLFHV$IRXUSRLQW VFDOH   YHU\ LUUHOHYDQWYHU\ XQFOHDUYHU\ GLIILFXOW   LUUHOHYDQW XQFOHDUGLIILFXOW  UHOHYDQWFOHDUHDV\  YHU\ UHOHYDQWYHU\ FOHDUYHU\ HDV\  ZDV LPSOHPHQWHG WR DYRLG KDYLQJDQHXWUDODQGDPELYDOHQWPLGSRLQWDQGWRGLFKRWRPL]HWKHUHVXOWVRIHDFKLWHP7KLV HQDEOHG XV WR GHFLGH ZKHWKHU FRQWHQW YDOLGLW\ FRPSUHKHQVLELOLW\ DQG NQRZOHGJH FRXOG EH FRQVLGHUHGSUHVHQWRUQRWIRUHDFKLWHP6FRUHVDQGZHUe considered ‘not present’, scores 3 and 4 were considered ‘present’. The ,&9,,&,DQG,',DUHSURSRUWLRQDOVFRUHVUDQJLQJ IURPFDOFXODWHGE\GLYLGLQJWKHQXPEHURIUHVSRQGHQWVWKDWFRQVLGHUHGWKHLWHPWREH ‘present’ by the total number of responGHQWV7KH6&9,ZDVFDOFXODWHGE\DYHUDJLQJWKH, &9,VFRUHVIRUWKHIXOO3*6*$6&,DQG6',RIWKHSDWLHQWJHQHUDWHGFRPSRQHQWRIWKH 3*6*$ZHUHFDOFXODWHGE\DYHUDJLQJ,&,VFRUHVDQG,',VFRUHVRI%R[HVWR6&,DQG6 ',RIWKHSURIHVVLRQDOFRPSRQHQWRIWKH3*6*$ZHUHFDOFXODWHGE\DYHUDJLQJ,&,VFRUHVDQG ,', VFRUHV RI :RUNVKHHWV  WR  7KH VFDOH LQGLFHV 6&, DQG 6', UHIOHFW RYHUDOO FRPSUHKHQVLELOLW\DQGGLIILFXOW\DVSHUFHLYHGE\SDWLHQWVIRUWKHSDWLHQWJHQHUDWHGFRPSRQHQW DQGDVSHUFHLYHGE\SURIHVVLRQDOVIRUWKHSURIHVVLRQDOFRPSRQHQW

$V SUHGHILQHG DQ ,&9, DERYH  ZDV FRQVLGHUHG H[FHOOHQW DQG DQ ,&9,  UHTXLUHVIXUWKHUDQDO\VLVRIWKHLWHP$Q6CVI≥0.80ZDVFRQVLGHUHGDFFHSWDEOHDQGDQ 6CVI≥0.90 was considered excellent.,QDJUHHPHQWZLWKWKHFRQWHQWYDOLGLW\DSSURDFKWKH VDPHFXWRIIVWDQGDUGVZHUHDSSOLHGWR,&,,',DQG6&,DQG6',VFRUHV7UDQVSDUHQF\RI

 UHVSRQVH ZDV SURYLGHG E\ UHSRUWLQJ RYHUDOO LWHP UHVSRQVH 3DWLHQWV DQG KHDOWKFDUH professionals’ non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

(16)

3

 DGDSWHGIRUWKLVVWXG\,QGLFHVIRULWHPFRPSUHKHQVLELOLW\ ,&, DQGLWHPGLIILFXOW\ ,',  ZHUHFDOFXODWHGDQGDYHUDJHGLQWRVFDOHFRPSUHKHQVLELOLW\LQGLFHV 6&, DQGVFDOHGLIILFXOW\ LQGLFHV 6',  7KHIROORZLQJSURFHGXUHZDVXVHGWRFDOFXODWHDOOLWHPDQGVFDOHLQGLFHV$IRXUSRLQW VFDOH   YHU\ LUUHOHYDQWYHU\ XQFOHDUYHU\ GLIILFXOW   LUUHOHYDQW XQFOHDUGLIILFXOW  UHOHYDQWFOHDUHDV\  YHU\ UHOHYDQWYHU\ FOHDUYHU\ HDV\  ZDV LPSOHPHQWHG WR DYRLG KDYLQJDQHXWUDODQGDPELYDOHQWPLGSRLQWDQGWRGLFKRWRPL]HWKHUHVXOWVRIHDFKLWHP7KLV HQDEOHG XV WR GHFLGH ZKHWKHU FRQWHQW YDOLGLW\ FRPSUHKHQVLELOLW\ DQG NQRZOHGJH FRXOG EH FRQVLGHUHGSUHVHQWRUQRWIRUHDFKLWHP6FRUHVDQGZHUe considered ‘not present’, scores 3 and 4 were considered ‘present’. The ,&9,,&,DQG,',DUHSURSRUWLRQDOVFRUHVUDQJLQJ IURPFDOFXODWHGE\GLYLGLQJWKHQXPEHURIUHVSRQGHQWVWKDWFRQVLGHUHGWKHLWHPWREH ‘present’ by the total number of responGHQWV7KH6&9,ZDVFDOFXODWHGE\DYHUDJLQJWKH, &9,VFRUHVIRUWKHIXOO3*6*$6&,DQG6',RIWKHSDWLHQWJHQHUDWHGFRPSRQHQWRIWKH 3*6*$ZHUHFDOFXODWHGE\DYHUDJLQJ,&,VFRUHVDQG,',VFRUHVRI%R[HVWR6&,DQG6 ',RIWKHSURIHVVLRQDOFRPSRQHQWRIWKH3*6*$ZHUHFDOFXODWHGE\DYHUDJLQJ,&,VFRUHVDQG ,', VFRUHV RI :RUNVKHHWV  WR  7KH VFDOH LQGLFHV 6&, DQG 6', UHIOHFW RYHUDOO FRPSUHKHQVLELOLW\DQGGLIILFXOW\DVSHUFHLYHGE\SDWLHQWVIRUWKHSDWLHQWJHQHUDWHGFRPSRQHQW DQGDVSHUFHLYHGE\SURIHVVLRQDOVIRUWKHSURIHVVLRQDOFRPSRQHQW

$V SUHGHILQHG DQ ,&9, DERYH  ZDV FRQVLGHUHG H[FHOOHQW DQG DQ ,&9,  UHTXLUHVIXUWKHUDQDO\VLVRIWKHLWHP$Q6CVI≥0.80ZDVFRQVLGHUHGDFFHSWDEOHDQGDQ 6CVI≥0.90 was considered excellent.,QDJUHHPHQWZLWKWKHFRQWHQWYDOLGLW\DSSURDFKWKH VDPHFXWRIIVWDQGDUGVZHUHDSSOLHGWR,&,,',DQG6&,DQG6',VFRUHV7UDQVSDUHQF\RI

 UHVSRQVH ZDV SURYLGHG E\ UHSRUWLQJ RYHUDOO LWHP UHVSRQVH 3DWLHQWV DQG KHDOWKFDUH professionals’ nonUHVSRQVHWRLWHPVZDVH[FOXGHGIURPWKHFDOFXODWLRQRIWKHLQGH[VFRUHV 5HVSHFWLYHO\,&,,',DQG,&9,SHULWHPDQG6&,6',DQG6&9,SHUVFDOHZHUHFDOFXODWHG LQ6366 ,%0,QF   5HVXOWV 7KHIRUZDUGWUDQVODWLRQSURFHVVSURYLGHGWKHILUVWWZR'XWFK WUDQVODWLRQVRIWKH3*6*$ 'XULQJWKHUHFRQFLOLDWLRQSKDVHFRQVHQVXVZDVUHDFKHGRQWKHGLIIHUHQFHV SDWLHQW UHSRUWHG LWHPV DQG  SURIHVVLRQDOUHSRUWHG LWHPV  WKDW ZHUH LGHQWLILHG EHWZHHQ WKH WZR IRUZDUGWUDQVODWLRQVLQWR'XWFK7KH'XWFKGRFXPHQWDWLRQRIWKHUHFRQFLOLDWLRQVHVVLRQFDQ EH SURYLGHG XSRQ UHTXHVW E\ WKH FRUUHVSRQGLQJ DXWKRU 7KH EDFN WUDQVODWLRQ DQG KDUPRQL]DWLRQSURFHVVUHVXOWHGLQHLJKWDGGLWLRQDODGDSWDWLRQV ILYHSDWLHQWUHSRUWHGLWHPV DQG WKUHH SURIHVVLRQDOUHSRUWHG LWHPV  'RFXPHQWDWLRQ RI WKH EDFN WUDQVODWLRQ UHYLHZ DQG KDUPRQL]DWLRQSURFHVVLVSUHVHQWHGLQ7DEOH7KHKDUPRQL]DWLRQSURFHVVUHVXOWHGLQDILYH SDJHGRFXPHQWDVSURWRW\SHRIWKH'XWFKYHUVLRQRIWKH3*6*$ (LJKW'XWFKKHDOWKFDUHSURIHVVLRQDOVFRPSOHWHGWKHTXHVWLRQQDLUHGHYHORSHGIRUWKH SURIHVVLRQDOVVL[GLHWLWLDQVRQHQXUVHSUDFWLWLRQHUDQGRQHPHGLFDOLQWHUQ:LWKLQWKLVVDPSOH VL[KHDOWKFDUHSURIHVVLRQDOVSDUWLFLSDWHGZLWKDSDWLHQWUHVXOWLQJLQVL[SDWLHQWVFRPSOHWLQJWKH TXHVWLRQQDLUHGHYHORSHGIRUWKHSDWLHQWV7KHVDPSOHRISDWLHQWVFRQVLVWHGRIIRXUZRPHQDQG WZRPHQ DJHG\HDUV ZLWKFDQFHU KHDGDQGQHFNFDQFHUQ SDQFUHDVFDQFHUQ  RYDULDQFDQFHUQ  'DWDRQGLIILFXOW\RILWHPVRIWKHSURIHVVLRQDOFRPSRQHQWRIWKH3*6*$ ZHUHPLVVLQJLQRQHKHDOWKFDUHSURIHVVLRQDO

(17)



7$%/('RFXPHQWDWLRQRIDGDSWDWLRQVPDGHLQWKHEDFNWUDQVODWLRQUHYLHZDQG KDUPRQL]DWLRQPHHWLQJ

%R[ 5HFRQFLOLDWLRQ 7UDQVODWRU 7UDQVODWRU

%R[–6\PSWRPV PRHLWHPHWVOLNNHQ GLIILFXOW\VZDOORZLQJ GLIILFXOW\ZLWKVZDOORZLQJ

%R[–$FWLYLWLHVDQG

IXQFWLRQLQJ 9DQGHDIJHORSHQPDDQGEHRRUGHHOLNPLMQDFWLYLWHLWHQDOV ,ZRXOGDVVHVVP\DFWLYLWLHVRIWKHSUHYLRXV PRQWKVDV

2YHUWKHSDVWPRQWK, ZRXOGUDWHP\DFWLYLWLHVDV %R[–$FWLYLWLHVDQG

IXQFWLRQLQJ EHSHUNWLQ]ZDUHOLFKDPHOLMNHDFWLYLWHLWPDDUDPEXODQWHQWRW OLFKWHDUEHLGLQVWDDW OLPLWHGKHDY\SK\VLFDO DFWLYLW\EXWDPEXODQW DQGDEOHWRSHUIRUPOLJKW ZRUN FDQQRWGRKHDY\SK\VLFDO DFWLYLWLHVEXWPRYLQJ DERXWDQGDEOHWRGROLJKW ZRUN %R[–$FWLYLWLHVDQG

IXQFWLRQLQJ VOHFKWVWRWEHSHUNWH]HOIYHU]RUJLQJLQVWDDWPHHUGDQYDQGHGDJ LQEHGRIRSVWRHO RQO\OLPLWHGVHOIFDUH PRUHWKDQRIWKH GD\LQEHGRUFKDLU XQDEOHWRORRNDIWHUP\VHOI VSHQGPRUHWKDQKDOIWKH GD\LQEHGRURQDFKDLU :RUNVKHHW 5HFRQFLOLDWLRQ 7UDQVODWRU 7UDQVODWRU

:RUNVKHHW –&DWHJRU\– 6WDJH%

OLFKWWRWPDWLJRQGHUYRHG PLOGWRPRGHUDWHO\

PDOQRXULVKHG OLJKWWRPRGHUDWHO\PDOQRXULVKHG :RUNVKHHW –&DWHJRU\– 6WDJH%DQG& DDQZH]LJKHLGYDQV\PSWRPHQGLH GHYRHGLQJVLQQDPHNXQQHQ YHUVWRUHQ SUHVHQFHRIV\PSWRPV WKDWPD\GLVUXSWWKH QXWULWLRQDOLQWDNH SUHVHQFHRIV\PSWRPVWKDW FRXOGLQIOXHQFHIRRGLQWDNH :RUNVKHHW3K\VLFDO H[DP–VWDJH% GXLGHOLMNPLOGHRIPDWLJHGHSOHWLHYDQYHWPDVVDRIVSLHUPDVVDHQRI VSLHUWRQXVELMSDOSDWLH PDUNHGPLOGRU PRGHUDWHGHSOHWLRQRI IDWPDVVRUPXVFOHPDVV DQGRUPXVFOHWRQH GXULQJSDOSDWLRQ FOHDUPLOGRUPRGHUDWH GHILFLWLQIDWVWRUHVRU PXVFOHPDVVRUWRQHRQ SDOSDWLRQ   

2ULJLQDO +DUPRQL]DWLRQ &RPPHQWV

SUREOHPVVZDOORZLQJ SUREOHPHQPHWVOLNNHQ “problemen” implies the symptom is VHULRXVHQRXJKQRWWREHDEOHWRHDW “moeite” could imply it takes more time EXWGRHVQRWDIIHFWLQWDNH

2YHUWKHSDVWPRQWK,ZRXOG

JHQHUDOO\UDWHP\DFWLYLW\DV ,NEHRRUGHHOPLMQDFWLYLWHLWHQYDQGHDIJHORSHQPDDQGRYHUKHWDOJHPHHQ DOV

to start with “Ik (I)” fits better in Dutch use of language; generally “over het algemeen” was added 

UHVWULFWHGLQSK\VLFDOO\VWUHQXRXV DFWLYLW\EXWDPEXODWRU\DQGDEOH WRFDUU\RXWOLJKWZRUN EHSHUNWLQ]ZDUHOLFKDPHOLMNH DFWLYLWHLWPDDUQLHWEHGOHJHULJHQWRW OLFKWHDUEHLGLQVWDDW 

“ambulant” appears to difficult. ”niet bedlegerig” is clearer to theSDWLHQW FDSDEOHRIRQO\OLPLWHGVHOIFDUH FRQILQHGWREHGRUFKDLUPRUH WKDQRIZDNLQJKRXUV VOHFKWVWRWEHSHUNWH]HOIYHU]RUJLQJLQ VWDDWPHHUGDQYDQGHGDJLQ EHGRIVWRHO

“;”interpunction added to clarify “op” deleted 

2ULJLQDO +DUPRQL]DWLRQ &RPPHQWV

PRGHUDWHO\PDOQRXULVKHGRU

VXVSHFWHGPDOQRXULVKHG PDWLJRQGHUYRHGRIYHUGHQNLQJRQGHUYRHGLQJ “verdenkingondervoeding”ZDVFKDQJHGWR“lichtWRWmatig”LQWKHIRUZDUG WUDQVODWHGDQGLVQRZFKDQJHGEDFNDJDLQ SUHVHQFHRIQXWULWLRQLPSDFW

V\PSWRPV ER[RI3*6*$  DDQZH]LJKHLGYDQV\PSWRPHQGLHGHYRHGLQJVLQQDPHYHUVWRUHQ “kunnen”GHOHWHGV\PSWRPVPXVWKDYHDFWXDOO\KLQGHUHGLQWDNHDVVWDWHGLQER[  HYLGHQFHRIPLOGWRPRGHUDWHORVV RI64IDW RUPXVFOHPDVV RU PXVFOHWRQHRQSDOSDWLRQ GXLGHOLMNPLOGHRIPDWLJHGHSOHWLHYDQ YHWPDVVDHQRIVSLHUPDVVDHQRI VSLHUWRQXVELMSDOSDWLH “en/of”DGGHGDIWHU“vetmassa”EHFDXVHLW LVGLIIHUHQWIURP“of”   

(18)

3



7$%/('RFXPHQWDWLRQRIDGDSWDWLRQVPDGHLQWKHEDFNWUDQVODWLRQUHYLHZDQG KDUPRQL]DWLRQPHHWLQJ

%R[ 5HFRQFLOLDWLRQ 7UDQVODWRU 7UDQVODWRU

%R[–6\PSWRPV PRHLWHPHWVOLNNHQ GLIILFXOW\VZDOORZLQJ GLIILFXOW\ZLWKVZDOORZLQJ

%R[–$FWLYLWLHVDQG

IXQFWLRQLQJ 9DQGHDIJHORSHQPDDQGEHRRUGHHOLNPLMQDFWLYLWHLWHQDOV ,ZRXOGDVVHVVP\DFWLYLWLHVRIWKHSUHYLRXV PRQWKVDV

2YHUWKHSDVWPRQWK, ZRXOGUDWHP\DFWLYLWLHVDV %R[–$FWLYLWLHVDQG

IXQFWLRQLQJ EHSHUNWLQ]ZDUHOLFKDPHOLMNHDFWLYLWHLWPDDUDPEXODQWHQWRW OLFKWHDUEHLGLQVWDDW OLPLWHGKHDY\SK\VLFDO DFWLYLW\EXWDPEXODQW DQGDEOHWRSHUIRUPOLJKW ZRUN FDQQRWGRKHDY\SK\VLFDO DFWLYLWLHVEXWPRYLQJ DERXWDQGDEOHWRGROLJKW ZRUN %R[–$FWLYLWLHVDQG

IXQFWLRQLQJ VOHFKWVWRWEHSHUNWH]HOIYHU]RUJLQJLQVWDDWPHHUGDQYDQGHGDJ LQEHGRIRSVWRHO RQO\OLPLWHGVHOIFDUH PRUHWKDQRIWKH GD\LQEHGRUFKDLU XQDEOHWRORRNDIWHUP\VHOI VSHQGPRUHWKDQKDOIWKH GD\LQEHGRURQDFKDLU :RUNVKHHW 5HFRQFLOLDWLRQ 7UDQVODWRU 7UDQVODWRU

:RUNVKHHW –&DWHJRU\– 6WDJH%

OLFKWWRWPDWLJRQGHUYRHG PLOGWRPRGHUDWHO\

PDOQRXULVKHG OLJKWWRPRGHUDWHO\PDOQRXULVKHG :RUNVKHHW –&DWHJRU\– 6WDJH%DQG& DDQZH]LJKHLGYDQV\PSWRPHQGLH GHYRHGLQJVLQQDPHNXQQHQ YHUVWRUHQ SUHVHQFHRIV\PSWRPV WKDWPD\GLVUXSWWKH QXWULWLRQDOLQWDNH SUHVHQFHRIV\PSWRPVWKDW FRXOGLQIOXHQFHIRRGLQWDNH :RUNVKHHW3K\VLFDO H[DP–VWDJH% GXLGHOLMNPLOGHRIPDWLJHGHSOHWLHYDQYHWPDVVDRIVSLHUPDVVDHQRI VSLHUWRQXVELMSDOSDWLH PDUNHGPLOGRU PRGHUDWHGHSOHWLRQRI IDWPDVVRUPXVFOHPDVV DQGRUPXVFOHWRQH GXULQJSDOSDWLRQ FOHDUPLOGRUPRGHUDWH GHILFLWLQIDWVWRUHVRU PXVFOHPDVVRUWRQHRQ SDOSDWLRQ   

2ULJLQDO +DUPRQL]DWLRQ &RPPHQWV

SUREOHPVVZDOORZLQJ SUREOHPHQPHWVOLNNHQ “problemen” implies the symptom is VHULRXVHQRXJKQRWWREHDEOHWRHDW “moeite” could imply it takes more time EXWGRHVQRWDIIHFWLQWDNH

2YHUWKHSDVWPRQWK,ZRXOG

JHQHUDOO\UDWHP\DFWLYLW\DV ,NEHRRUGHHOPLMQDFWLYLWHLWHQYDQGHDIJHORSHQPDDQGRYHUKHWDOJHPHHQ DOV

to start with “Ik (I)” fits better in Dutch use of language; generally “over het algemeen” was added 

UHVWULFWHGLQSK\VLFDOO\VWUHQXRXV DFWLYLW\EXWDPEXODWRU\DQGDEOH WRFDUU\RXWOLJKWZRUN EHSHUNWLQ]ZDUHOLFKDPHOLMNH DFWLYLWHLWPDDUQLHWEHGOHJHULJHQWRW OLFKWHDUEHLGLQVWDDW 

“ambulant” appears to difficult. ”niet bedlegerig” is clearer to theSDWLHQW FDSDEOHRIRQO\OLPLWHGVHOIFDUH FRQILQHGWREHGRUFKDLUPRUH WKDQRIZDNLQJKRXUV VOHFKWVWRWEHSHUNWH]HOIYHU]RUJLQJLQ VWDDWPHHUGDQYDQGHGDJLQ EHGRIVWRHO

“;”interpunction added to clarify “op” deleted 

2ULJLQDO +DUPRQL]DWLRQ &RPPHQWV

PRGHUDWHO\PDOQRXULVKHGRU

VXVSHFWHGPDOQRXULVKHG PDWLJRQGHUYRHGRIYHUGHQNLQJRQGHUYRHGLQJ “verdenkingondervoeding”ZDVFKDQJHGWR“lichtWRWmatig”LQWKHIRUZDUG WUDQVODWHGDQGLVQRZFKDQJHGEDFNDJDLQ SUHVHQFHRIQXWULWLRQLPSDFW

V\PSWRPV ER[RI3*6*$  DDQZH]LJKHLGYDQV\PSWRPHQGLHGHYRHGLQJVLQQDPHYHUVWRUHQ “kunnen”GHOHWHGV\PSWRPVPXVWKDYHDFWXDOO\KLQGHUHGLQWDNHDVVWDWHGLQER[  HYLGHQFHRIPLOGWRPRGHUDWHORVV RI64IDW RUPXVFOHPDVV RU PXVFOHWRQHRQSDOSDWLRQ GXLGHOLMNPLOGHRIPDWLJHGHSOHWLHYDQ YHWPDVVDHQRIVSLHUPDVVDHQRI VSLHUWRQXVELMSDOSDWLH “en/of”DGGHGDIWHU“vetmassa”EHFDXVHLW LVGLIIHUHQWIURP“of”   

(19)

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………..    %R[$FWLYLWLHVDQG)XQFWLRQ D2YHUWKHSDVWPRQWK,ZRXOGJHQHUDOO\UDWHP\DFWLYLW\DV   1    1    DQRUPDOZLWKQROLPLWDWLRQV   1     DQRWP\QRUPDOVHOIEXWDEOHWREHXSDQGDERXWZLWKIDLUO\   QRUPDODFWLYLWLHV   1     DQRWIHHOLQJXSWRPRVWWKLQJVEXWLQEHGRUFKDLUOHVVWKDQ   KDOIWKHGD\   1     DDEOHWRGROLWWOHDFWLYLW\DQGVSHQGPRVWRIWKHGD\LQEHG   RUFKDLU   1     DSUHWW\PXFKEHGULGGHQUDUHO\RXWRIEHG   1    6FDOH,QGLFHV3DWLHQW*HQHUDWHG&RPSRQHQW 6&9,   6&,   6',    2YHUDOOLWHPUHVSRQVH   

,&9,LWHPFRQWHQWYDOLGLW\LQGH[,&,LWHPFRPSUHKHQVLELOLW\LQGH[,',LWHPGLIILFXOW\LQGH[ 6&9,VFDOHFRQWHQWYDOLGLW\LQGH[6&,VFDOHFRPSUHKHQVLELOLW\LQGH[6',VFDOHGLIILFXOW\LQGH[ LQFOQRQUHVSRQVHLQFOQRQUHVSRQVHLQFOQRQUHVSRQVH

,&9,,&,,',!H[FHOOHQW6&9,6&,6',!DFFHSWDEOH6&9,6&,6',!H[FHOOHQW

(20)

3

 7$%/(,QGLFHVIRUFRQWHQWYDOLGLW\FRPSUHKHQVLELOLW\DQGGLIILFXOW\IRUWKHSDWLHQW JHQHUDWHGFRPSRQHQWRIWKH'XWFK3*6*$DVSHUFHLYHGE\SURIHVVLRQDOVDQGSDWLHQWV ZLWKFDQFHU 6DPSOH SURIHVVLRQDOV SDWLHQWV 3DWLHQWV ,WHP ,&9, 1   ,&, 1   ,', 1   %R[:HLJKW D,FXUUHQWO\ZHLJKDERXWBBBBBBBSRXQGV    E,DPDERXWBBBBBBBBBIHHWBBBBBBBBBWDOO    F2QHPRQWKDJR,ZHLJKHGDERXWBSRXQGV    G6L[PRQWKVDJR,ZHLJKHGDERXWBBSRXQGV    H'XULQJWKHSDVWWZRZHHNVP\ZHLJKWKDV GHFUHDVHGQRWFKDQJHGLQFUHDVHG    %R[)RRGLQWDNH D$VFRPSDUHGWRP\QRUPDOLQWDNH,ZRXOGUDWHP\IRRGLQWDNH GXULQJWKHSDVWPRQWKDV    1    1    DXQFKDQJHG    1     DPRUHWKDQXVXDO   1     DOHVVWKDQXVXDO    E,DPQRZWDNLQJ  1    1    1    EQRUPDOIRRGEXWOHVVWKDQQRUPDODPRXQW   1     EOLWWOHVROLGIRRGV  1    1     ERQO\OLTXLGV   1     ERQO\QXWULWLRQDOVXSSOHPHQWV   1     EYHU\OLWWOHRIDQ\WKLQJ  1    1     ERQO\WXEHIHHGLQJVRURQO\QXWULWLRQE\YHLQ    %R[6\PSWRPV D,KDYHKDGWKHIROORZLQJSUREOHPVWKDWKDYHNHSWPHIURP HDWLQJHQRXJKGXULQJWKHSDVWWZRZHHNV     1    DQRSUREOHPVHDWLQJ     DQRDSSHWLWHMXVWGLGQRWIHHOOLNHHDWLQJ     D1DXVHD     D&RQVWLSDWLRQ       7$%/(&RQWLQXHG  6DPSOH SURIHVVLRQDOV SDWLHQWV SDWLHQWV ,WHP ,&9, 1   ,&, 1   ,', 1    DPRXWKVRUHV     DWKLQJVWDVWHIXQQ\RUKDYHQRWDVWH     DSUREOHPVVZDOORZLQJ     DSDLQZKHUH"     D9RPLWLQJ     D'LDUUKHD     DGU\PRXWK     DVPHOOVERWKHUPH     DIHHOIXOOTXLFNO\     D)DWLJXH     DRWKHU………..    %R[$FWLYLWLHVDQG)XQFWLRQ D2YHUWKHSDVWPRQWK,ZRXOGJHQHUDOO\UDWHP\DFWLYLW\DV   1    1    DQRUPDOZLWKQROLPLWDWLRQV   1     DQRWP\QRUPDOVHOIEXWDEOHWREHXSDQGDERXWZLWKIDLUO\   QRUPDODFWLYLWLHV   1     DQRWIHHOLQJXSWRPRVWWKLQJVEXWLQEHGRUFKDLUOHVVWKDQ   KDOIWKHGD\   1     DDEOHWRGROLWWOHDFWLYLW\DQGVSHQGPRVWRIWKHGD\LQEHG   RUFKDLU   1     DSUHWW\PXFKEHGULGGHQUDUHO\RXWRIEHG   1    6FDOH,QGLFHV3DWLHQW*HQHUDWHG&RPSRQHQW 6&9,   6&,   6',    2YHUDOOLWHPUHVSRQVH   

,&9,LWHPFRQWHQWYDOLGLW\LQGH[,&,LWHPFRPSUHKHQVLELOLW\LQGH[,',LWHPGLIILFXOW\LQGH[ 6&9,VFDOHFRQWHQWYDOLGLW\LQGH[6&,VFDOHFRPSUHKHQVLELOLW\LQGH[6',VFDOHGLIILFXOW\LQGH[ LQFOQRQUHVSRQVHLQFOQRQUHVSRQVHLQFOQRQUHVSRQVH

,&9,,&,,',!H[FHOOHQW6&9,6&,6',!DFFHSWDEOH6&9,6&,6',!H[FHOOHQW

(21)



7$%/(  ,QGLFHV IRU FRQWHQW YDOLGLW\ FRPSUHKHQVLELOLW\ DQG GLIILFXOW\ IRU WKH SURIHVVLRQDOFRPSRQHQWRIWKH'XWFK3*6*$DVSHUFHLYHGE\SURIHVVLRQDOV

6DPSOH SURIHVVLRQDOV SURIHVVLRQDOV SURIHVVLRQDOV ,WHP ,&9, 1   ,&, 1   ,', 1   :RUNVKHHW6FRULQJ:HLJKW/RVV    1   :RUNVKHHW'LVHDVHDQGLWVUHODWLRQWRQXWULWLRQDO UHTXLUHPHQWV    1   D$OOUHOHYDQWGLDJQRVHV    E3ULPDU\GLVHDVHVWDJH  1     F$JH  1     :RUNVKHHW0HWDEROLF'HPDQG D)HYHU    E)HYHUGXUDWLRQ    F&RUWLFRVWHURLGV    :RUNVKHHW3K\VLFDO([DP D0XVFOH6WDWXV  1     1    D7HPSOHV WHPSRUDOLVPXVFOH   1     1    D&ODYLFOHV SHFWRUDOLV GHOWRLGV   1     1    D6KRXOGHUV GHOWRLGV   1     1    D,QWHURVVHRXVPXVFOHV  1     1    D6FDSXOD  1     1    D7KLJK TXDGULFHSV   1     1    D&DOI JDVWURFQHPLXV   1     1   E)DWVWRUHV  1     1    E2UELWDOIDWSDGV  1     1    E7ULFHSVVNLQIROG  1     1    E)DWRYHUO\LQJORZHUULEV  1     1   F)OXLGVWDWXV  1     1    F$QNOHHGHPD  1     1      7DEOH&RQWLQXHG 

6DPSOH SURIHVVLRQDOV SURIHVVLRQDOV SURIHVVLRQDOV ,WHP ,&9, 1   ,&, 1   ,', 1    F6DFUDOHGHPD    1    F$VFLWHV    1   :RUNVKHHW*OREDO$VVHVVPHQW&DWHJRULHV  1     1   D:HLJKW    E1XWULHQWLQWDNH    F1XWULWLRQ,PSDFW6\PSWRPV    G)XQFWLRQLQJ    H3K\VLFDOH[DP    *OREDO3*6*$5DWLQJ  1     7ULDJH1RLQWHUYHQWLRQUHTXLUHGDWWKLVWLPH    7ULDJH3DWLHQW IDPLO\HGXFDWLRQ    7ULDJH  LQWHUYHQWLRQ E\ GLHWLWLDQ LQ FRQMXQFWLRQ ZLWK

QXUVHRUSK\VLFLDQDVLQGLFDWHGE\V\PSWRPV    7ULDJH≥9:FULWLFDOQHHGIRULPSURYHGV\PSWRPPDQDJHPHQW

DQGRUQXWULHQWLQWHUYHQWLRQRSWLRQV   

6FDOH,QGLFHV3URIHVVLRQDO&RPSRQHQW 6&9,  6&,  6', 

,WHPUHVSRQVH3URIHVVLRQDO&RPSRQHQW    6FDOH,QGLFHV)XOO3*6*$ 6&9,   

2YHUDOOLWHPUHVSRQVH   

,&9,LWHPFRQWHQWYDOLGLW\LQGH[,&,LWHPFRPSUHKHQVLELOLW\LQGH[,',LWHPGLIILFXOW\LQGH[6&9,

VFDOHFRQWHQWYDOLGLW\LQGH[6&,VFDOHFRPSUHKHQVLELOLW\LQGH[6',VFDOHGLIILFXOW\LQGH[LQFOQRQ

UHVSRQVH LQFO QRQUHVSRQVH LQFO QRQUHVSRQVH  ,&9,,&,,',! H[FHOOHQW 6

(22)

3



7$%/(  ,QGLFHV IRU FRQWHQW YDOLGLW\ FRPSUHKHQVLELOLW\ DQG GLIILFXOW\ IRU WKH SURIHVVLRQDOFRPSRQHQWRIWKH'XWFK3*6*$DVSHUFHLYHGE\SURIHVVLRQDOV

6DPSOH SURIHVVLRQDOV SURIHVVLRQDOV SURIHVVLRQDOV ,WHP ,&9, 1   ,&, 1   ,', 1   :RUNVKHHW6FRULQJ:HLJKW/RVV    1   :RUNVKHHW'LVHDVHDQGLWVUHODWLRQWRQXWULWLRQDO UHTXLUHPHQWV    1   D$OOUHOHYDQWGLDJQRVHV    E3ULPDU\GLVHDVHVWDJH  1     F$JH  1     :RUNVKHHW0HWDEROLF'HPDQG D)HYHU    E)HYHUGXUDWLRQ    F&RUWLFRVWHURLGV    :RUNVKHHW3K\VLFDO([DP D0XVFOH6WDWXV  1     1    D7HPSOHV WHPSRUDOLVPXVFOH   1     1    D&ODYLFOHV SHFWRUDOLV GHOWRLGV   1     1    D6KRXOGHUV GHOWRLGV   1     1    D,QWHURVVHRXVPXVFOHV  1     1    D6FDSXOD  1     1    D7KLJK TXDGULFHSV   1     1    D&DOI JDVWURFQHPLXV   1     1   E)DWVWRUHV  1     1    E2UELWDOIDWSDGV  1     1    E7ULFHSVVNLQIROG  1     1    E)DWRYHUO\LQJORZHUULEV  1     1   F)OXLGVWDWXV  1     1    F$QNOHHGHPD  1     1      7DEOH&RQWLQXHG 

6DPSOH SURIHVVLRQDOV SURIHVVLRQDOV SURIHVVLRQDOV ,WHP ,&9, 1   ,&, 1   ,', 1    F6DFUDOHGHPD    1    F$VFLWHV    1   :RUNVKHHW*OREDO$VVHVVPHQW&DWHJRULHV  1     1   D:HLJKW    E1XWULHQWLQWDNH    F1XWULWLRQ,PSDFW6\PSWRPV    G)XQFWLRQLQJ    H3K\VLFDOH[DP    *OREDO3*6*$5DWLQJ  1     7ULDJH1RLQWHUYHQWLRQUHTXLUHGDWWKLVWLPH    7ULDJH3DWLHQW IDPLO\HGXFDWLRQ    7ULDJH  LQWHUYHQWLRQ E\ GLHWLWLDQ LQ FRQMXQFWLRQ ZLWK

QXUVHRUSK\VLFLDQDVLQGLFDWHGE\V\PSWRPV    7ULDJH≥9:FULWLFDOQHHGIRULPSURYHGV\PSWRPPDQDJHPHQW

DQGRUQXWULHQWLQWHUYHQWLRQRSWLRQV   

6FDOH,QGLFHV3URIHVVLRQDO&RPSRQHQW 6&9,  6&,  6', 

,WHPUHVSRQVH3URIHVVLRQDO&RPSRQHQW    6FDOH,QGLFHV)XOO3*6*$ 6&9,   

2YHUDOOLWHPUHVSRQVH   

,&9,LWHPFRQWHQWYDOLGLW\LQGH[,&,LWHPFRPSUHKHQVLELOLW\LQGH[,',LWHPGLIILFXOW\LQGH[6&9,

VFDOHFRQWHQWYDOLGLW\LQGH[6&,VFDOHFRPSUHKHQVLELOLW\LQGH[6',VFDOHGLIILFXOW\LQGH[LQFOQRQ

UHVSRQVH LQFO QRQUHVSRQVH LQFO QRQUHVSRQVH  ,&9,,&,,',! H[FHOOHQW 6

Referenties

GERELATEERDE DOCUMENTEN

Beste Bernarda, echtgenoot van Pieter, u zult ongetwijfeld het nodige hebben meegekregen waar we met het onderzoek tegenaan zijn gelopen. Bedankt dat je Pieter de mogelijkheid

In this study, based on a large study population (n=730) with a variety of tumour and treatment characteristics, we therefore (1) determined the prevalence of trismus and

De belasting voor de hoofd-halskanker patiënt tijdens oefentherapie voor trismus, staat niet in verhouding tot het effect van deze therapie. Oefentherapie voor trismus bij

Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright

 DGGLWLRQZHQHHGEHWWHULQVLJKWLQWRWKHSV\FKRORJLFDOPHFKDQLVPVWKDWLQIOXHQFHSK\VLFDO DFWLYLW\LQSDWLHQWVZLWKKHDGDQGQHFNFDQFHU 

 LQGHSHQGHQWO\ $Q\ GLVDJUHHPHQW RQ GDWD SURSHUWLHV WKDW FRXOG QRW EH UHVROYHG E\ FRQVHQVXV ZDV UHVROYHG E\ FRQVXOWLQJ D WKLUG DXWKRU ZKR

,Q WKLV SURVSHFWLYH HYDOXDWLRQ VWXG\ FKDUDFWHULVWLFV RI SHUFHLYHG GLIILFXOW\ DQG

7KH UHVXOWV RI RXU VWXG\ LQGLFDWH WKDW FURVVVHFWLRQDO PHDVXUHPHQWV RI ODUJH DQG