഑‫ؠ‬͹ϧϱξϞԿർֳࢾ‫ݩ‬ʤNʻ163ʥ
Ͷ͕͜Ζ༙֒ࣆেๅࠄ

PROͲMOTE‫ڂݜ‬Ͷͯ͏ͱҫྏๅࠄͶർ΄ɼ‫ं׳‬ๅࠄͺͲ ΓΕ૥͚ઔ࡜ҫՌ୉ָ ೗ધߗয়ધ֐ՌָͲ ළౕ͗߶͏ฑ ੔ਕ

2022/10/15୊14յ CSPͲHOR೧ճPRO͹ఈٝҫྏं඲ՃʤCTCAEʥͳ‫ं׳‬඲Ճͳ͹Ҳ஗ིz ঳য়ͶΓΕҲ஗ིͺҡ͵Ζ

PatientsReportedOutcome¾ ఈٝ
Ͳ “Patients’reportofahealthconditionanditstreatment”(Valuehealth2003)

յ਼ͶΓΕ඲ՃͲ
͘Ζ঳য়͹Ҳ஗ི͗ർֳద߶͏

Ͳ “Anyreportofthestatusofapatient’shealthconditionthat
comesdirectlyfromthepatient,withoutinterpretationofthepatient’sresponsebyaclinicianoranyoneelse”(FDAPROΪ΢ξϱηɾ2009)“ҫྏंΏ୊ࢀं͹մएΝ‫=|͏͵ܨ‬क؏੓Ν॑ࢻ͗Ξ྘ҮͲPROΝ඲ՃͤΖқٝz ྡজࢾ‫ݩ‬͹॑གྷ͵Φϱχϛ΢ϱφͳ͢ͱ ҫྏं͹XQGHUUHSRUWLQJ ਬওΪ΢χϧ΢ϱ
ʀ$6&2UHFRPPHQGDWLRQʀ)'$352JXLGDQFH
ʀ(602ʤ&OLQLFDO%HQHILW6FDOHʥz ೖ৙͹͗ΞਏྏͶ͕͜Ζ঳য়ϠωνϨϱήͳ͢ͱ ుࢢͲυώ΢η͹‫ٺ‬ଐ͵෕‫ٶ‬ ‫Ͳࡑݳ‬ͺɼHOHFWURQLF352V H352 ͹ཤ༽͗Ն೵ͳ͵ͮͪ1ͲyearsurvivalrateɼSTAR=75%,Usualcare69%,p=0.05

 ઎ߨ‫ڂݜ‬ͶΓΖH352͹༙༽੓͹ๅࠄBasch E,etal.JClinOncol.2016;34:557–565.

Basch E,etal.JAMA2017;318:1935Ͳ1936.

͗ΞਏྏͶ͕͜ΖPROϠωνϨϱή͹қٝͲ‫ं׳‬ຮଏౕ͹րવͲ‫ं׳‬ʀҫྏंαϝωίʖεϥϱ͹րવͲ॑ಠ͵༙֒ࣆে͹૥‫غ‬൅‫ݡ‬Ͳ؉࿪ίΠ͹૥‫غ‬ղ೘Ͳ‫ं׳‬ΠΤφΩϞ͹րવ (QoL,સਫ਼ଚ‫)ؔغ‬

UMINͲCTRࢾ‫໌ݩ‬ଲে࣮‫׳‬ࣰࢬૌ৭ࢾ‫ݩ‬υδ΢ϱN

RESPECTstudy഑‫ؠ‬ɼ‫ڵ‬ຜ஦ൿञɼভԿ‫ؠح‬
ʤICI౦༫ྭʥ౨‫ښ‬ҫՌ୉ָ؏ࡱ‫ڂݜ‬290

FORECASTstudy୉ௐ‫ؠ‬ɼҥ‫ؠ‬ɼᢆ‫ؠ‬ɼ஀ಕ‫ؠ‬ʤ‫ࡐؠ߇޳ܨ‬ʥൂԨࢢ༂ࡐιϱνʖ؏ࡱ‫ڂݜ‬

80

CONNRCTͲePRO
study֐པԿָྏ๑

‫౐ښ‬୉ָ

؏ࡱ‫ڂݜ‬

750

ASTROࢾ‫ݩ‬೗‫ؠ‬ʤึঁԿָྏ๑ʥ

੗༂Ռ୉ָ؏ࡱ‫ڂݜ‬250

LIBRAࢾ‫ݩ‬೗‫ؠ‬ʤΠϗϜεέϨϔʥ‫ܜ‬ጱٝग़୉ָ

RCT

60

QOLͲePACᢆଃ‫ؠ‬ʤ࣏̐Կָྏ๑ʥ

ҏྜྷ୉ָ؏ࡱ‫ڂݜ‬

150

RegiPRO study‫ؠܙݽ‬੡ϜϨΠϱψҫՌ୉ָ؏ࡱ‫ڂݜ‬

400

ePROΝ༽͏ͪ෯ࡠ༽Ϝϋζϟϱφ೗‫ؠ‬૮ྒྷබӅ؏ࡱ‫ڂݜ‬

80

PROͲMOTE

‫ؠܙݽ‬

CSPOR

RCT

1500

ePROϠωνϨϱή௒ࠬ‫ڂݜ‬఺Ң೗‫ؠ‬Ԯࢃ୉ָ؏ࡱ‫ڂݜ‬200

NOVOͲGQoLstudyҥ‫ؠ‬ʤωϚϩϜϔʥ੡ϜϨΠϱψҫՌ୉ָ؏ࡱ‫ڂݜ‬30؏ࡱ‫ڂݜ‬,9;RCT, 2

PRO-MOTEjRCT

Patient Reported Outcomes study using electronic MOnitoring sysTEm
for advanced or metastatic solid cancerࢾ‫໌ݩ‬ଲে࣮‫׳‬ࣰࢬૌ৭ࢾ‫ݩ‬υδ΢ϱN

CarbonatiticePRO
studyਝࡋ๖͗ΞʤΩϚδϱοωϔ౦༫ྭʥ

๼քಕ୉ָ
ʤଡࢬઅʥ

Phase2,RCT105

PROͲDUCE೗͗ΞʤΦϱύʖς౦༫ྭʥ๼཮୉ָʤଡࢬઅɼCSPORͲBCʥ

RCT110ᄂᆮƷಒᙲЏᨊɧᏡᡶᘍƕǜƓǑƼ᠃ᆆȷϐႆ‫࢟׍‬ƕǜधᎍƴ‫ݣ‬Ƣǔ
'NGEVTQPKE2CVKGPV4GRQTVGF1WVEQOG G241 ȢȋǿȪȳǰƷஊဇࣱǛ౨ᚰƢǔ‫଀ٶ‬ᚨσӷ᩼Ⴙ౨ȩȳȀȠ҄ൔ᠋ᚾ᬴Ƃᚾ᬴ӸဦᆅᲴ241/16'ƃ

5VWF[ UEJGOCଲে࣮‫׳‬ʁ઀ঈ෈೵਒ߨ͗Ξ͕Γ;఺Ңʀ࠸൅‫͗ܙݽ‬Ξ‫ं׳‬
೧ྺʁ20ࡂҐ৏80ࡂາຮ࣑ྏʁ͗ΞͶଲͤΖસਐ༂෼ྏ๑Νࣰࢬ஦Ήͪͺౌ࿧ೖ͖Δ1͖݆Ґ಼Ͷࣰࢬ༩ఈ1ʛ3࣏࣑ྏΝଲেుࢢυώ΢ηʁࣙਐͲଲԢՆ೵΍͚͢ͺҲ෨ึঁ͗චགྷׄ෉௒੖Ҿࢢʀ͗ΞझʀPSʀ࣑ྏϧ΢ϱʀ೧ྺʀ͗ΞझพҾࢢຌ‫ڂݜ‬͹ઈ໎ʀಋқखಚౌ࿧ϧϱξϞׄ෉ϠωνϨϱή‫܊‬750ྭ
͗ΞझຘͶ‫و‬ఈͪ͢ePROϠωνϨϱή
঳য়ऊౕʁPROͲCTCAEʤ10Ͳ15ߴ໪ఖౕʥ࣎‫غ‬ʁౌ࿧࣎ʤ+7ೖʥౌ࿧‫ޛ‬1ुຘʤʸ2ೖʥ‫ؔغ‬ʁౌ࿧͖࣎Δ2025೧5݆຦Ήͪͺ͗ΞͶଲͤΖ੷‫ۅ‬ద͵࣑ྏश྅ΉͲଲল‫܊‬
750ྭ
௪৙ਏྏ

ҫྏंଈ΍
ϨΠϩν΢ϞͶ
‫ݡ‬Ζ͞ͳ͗Ͳ͘Ήͤҫྏंଈͺ‫ݡ‬Ζ͞ͳ͗Ͳ͘ΉͦΞ

HRQoL඲Ճ
ʀHRQoLऊౕʁEORTCQLQͲC30
࣎‫غ‬ʁౌ࿧࣎ʤ+7ೖʥҐ‫ޛ‬4ुຘɼ24ु໪ΉͲ
ऊౕʁEQͲ5DͲ5L࣎‫غ‬ʁౌ࿧࣎ʤ+7ೖʥҐ‫ޛ‬4ुຘɼౌ࿧͖࣎Δ2025೧5݆຦ΉͲʀ࣑ྏ‫ؖ‬࿊ΠΤφΩϞʀ‫ं׳‬ҫྏंαϝϣωίʖεϥϱऊౕʁEORTCQLQͲCOMU26࣎‫غ‬ʁౌ࿧࣎ʤ+7ೖʥౌ࿧‫ޛ‬24ु໪ʤʸ2ुʥʀҫྏ‫ࡃܨ‬඲ՃΠΤφΩϞ඲Ճकགྷ඲Ճߴ໪ʁOSɼHRQoL෯࣏ద඲Ճߴ໪ʁQALYɼࡑ୒Ͳ͹ࢰ๤ׄ߻ɼ࠹श༂෼ྏ๑͖Δࢰ๤ΉͲ͹‫ؔغ‬ɼ༩ఈ֐པӅյ਼ɼ༂෼ྏ๑͹RDIʀϪζϟϱ਼ɼICERɼ‫ं׳‬ҫྏंαϝϣωίʖεϥϱ
2023೧11݆30ೖʁ஦ؔ఺‫ؾ‬௒ࠬ
2025೧ 5݆31ೖʁ࠹श఺‫ؾ‬௒ࠬᢠ৸ؕแ ЏᨊɧᏡƳᡶᘍȷ᠃ᆆȷϐႆƷ‫࢟׍‬ƕǜ ႇ᥵଺ƔǒƔஉˌɥŴᐯೞ᧙ưƷ඙ၲŴƋǔƍƸᚇ‫ݑ‬ƕᙸᡂǊǔ '%1)Ʒ25ƕ ႇ᥵଺ໜưŴƕǜƴ‫ݣ‬Ƣǔμ៲ᕤཋၲඥᲢኬᏘᨦࣱܹ৴ƕǜᕤŴЎ‫܇‬೅ႎᕤŴβ၃ȁǧȃǯȝǤȳȈ᧹ܹᕤሁᲣǛҥдǋƠƘƸ́ဇ৲ɨưܱ଀ƠƯƍǔŴǇƨƸႇ᥵ଐǑǓƔஉˌϋƴӷᕤཋၲඥǛ᧏‫ڼ‬ʖ‫ܭ‬ᲢҾЩƱƠƯ‫ٳ‬ஹᕤཋၲඥưƷ඙ၲǛ‫ݣ‬ᝋƱƢǔᲣ ᩓ‫܇‬ȇȐǤǹƷ‫ࣖݣ‬ƕӧᏡưƋǔᲢɟᢿᙀяƕ࣏ᙲƳ‫ئ‬ӳǋԃǉᲣ ӷॖӕࢽ଺Ʒ࠰ᱫƕബˌɥബச฼ưƋǔ ‫ݣ‬ᝋᎍஜʴƔǒஜᄂᆮƴ‫ݣ‬ƠƯ૨୿ƴǑǔӷॖƕࢽǒǕƯƍǔ16ᄂᆮǹǱǸȥȸȫᲢʼλƱᚸ̖Უᨊ‫ؕٳ‬แ ᡶᘍȷ᠃ᆆȷϐႆƷ‫࢟׍‬ƕǜƴ‫ݣ‬ƠŴഏˌࢸƷᕤཋၲඥǛܱ଀ƠƯƍǔᲤදඅ‫ंݩ‬͹
QOL௒ࠬյ౶࣎‫غ‬ 241Ǜᛦ௹ƠŴƔƭᛦ௹ኽௐƕҔၲᎍƴᢩΨƞǕǔᄂᆮƴӋьƠƯƍǔ ƦƷ˂Ŵᄂᆮᝧ˓ҔࠖǇƨƸᄂᆮЎਃҔࠖƕஜᄂᆮƷႇ᥵ƴƸɧᢘ࢘ƱЙૺƠƨ‫ئ‬ӳᲤදᲴ ԗᘐ஖ᙀя҄‫ܖ‬ၲඥɶƷϐႆŴǇƨƸᙀя҄‫ܖ‬ၲඥࢸᡵˌϋƷϐႆၐ̊ưƸŴᙀя҄‫ܖ‬ၲඥǛഏၲඥƱƠƯৢƏ ʐƕǜƴ‫ݣ‬ƢǔϋЎඣၲඥƸԃǇƳƍŵ17͗Ξझพ͹ϠωνϨϱήߴ໪ͳΠϧʖφᮤ஍͹અఈz PROͲCTCAEitems͖ΔΦΫηϏʖφΨϒωΨϱͶΓΕઅఈ೗‫ؠ‬,13ߴ໪;഑‫ؠ‬,6ߴ໪;ҥ‫ ؠ‬11ߴ໪;୉ௐ͗Ξ 11ߴ໪;ᶅᶆᶇᶈଲল‫܊‬

ᶅᶆᶇ

ᶅ

ᶆ

ᶇ

ᶈ

EQͲ5DͲ5L

EORTC
QLQͲC30EORTCQLQͲCOMU26

PROͲCTCAE˖ౌ࿧࣎+7ೖː˖˖˖ౌ࿧‫ ޛ‬1ु໪ʸ2ೖؑؑؑ˖ౌ࿧‫ޛ‬1ुຘʤʸ2ೖʥʸ2ु˖˖ؑౌ࿧‫ ޛ‬8ु໪ʸ2ु˖˖ؑౌ࿧‫ ޛ‬12ु໪ʸ2ु˖˖ؑౌ࿧‫ ޛ‬16ु໪ʸ2ु˖˖ؑౌ࿧‫ ޛ‬20ु໪ʸ2ु˖˖ؑౌ࿧‫ ޛ‬24ु໪ʸ2ु˖˖ʤ24ु໪ΉͲʥ˖

2023/11/30
஦ؔ఺‫ؾ‬௒ࠬҐ‫ ޛ‬4ुຘ
ʤ2025/5/31ΉͲʥ

ʸ2ु

˖

ؑ

ؑ

2025/5/31
࠹श఺‫ؾ‬௒ࠬSample of the patient input screen
PROͲCTCAE

PROͲCTCAE

PROͲCTCAE

Ex.೗͗Ξ
ߴ໪

1
2
3
4
5
6
7
8
9
10
11
1213ৱཋ෈৾ృ͘‫ـ‬
ᅇృ
สඁ
Ծཫ
ଋ઀Η
֑
௩Ί
෈ເ
᷼ଷ‫״‬
෈҈
घଏ঳ޫ‫܊‬͢;Η

॑঳ౕ
SevereSevereSevereͲͲModerate
ModerateSevereͲ
SevereͲͲͲΠϧʖφ൅ਫ਼ᮤ஍ළౕਫ਼‫΃׈‬͹ࢩ্Ͳ
Quiteabit
FrequentlyͲ
FrequentlyͲͲͲ
AlmostconstantlyͲͲ
SomewhatͲ
SomewhatFrequently
QuiteabitͲͲ
QuiteabitͲͲͲͲͲͲඅ‫ंݩ‬ഐ‫ܢ‬ౌ࿧‫ ޛ‬4ु໪ಆܳ෨‫ؠ‬,11ߴ໪;،ଃ‫ ؠ‬10ߴ໪;ࢢ‫ٸ‬ର‫ ؠ‬12ߴ໪; ཝ૧‫ ؠ‬11ߴ໪No.

‫୴ڂݜ‬౲ंͶΓΖ
EDC೘ྙ࣎‫غ‬ʀΠ ϧ ổ φ ௪ எ ‫ ޛ‬͹ ଲ Ԣʀ஦ ࢯ ࣎ Ͷ ͺ ‫ و‬ఈ ߴ ໪ Ν ೘ ྙ ƕǜᆔКƷᨊ‫ؕٳ‬แƱƠƯŴˌɦƷǑƏƴ‫ܭ‬ǊǔĬ ʐƕǜ• țȫȢȳӖܾ˳ࣱᨗ̊ƴ‫ݣ‬ƢǔϋЎඣၲඥᲢ˂дƱƷ́ဇǛԃǉᲣǛܱ଀ʖ‫ܭ‬ŴƋǔƍƸܱ଀ƠƯƍǔ• *'4ࣱᨗ̊ƴ‫ݣ‬ƢǔИ‫ׅ‬Ʒ৴*'4ၲඥǛܱ଀ʖ‫ܭ‬ŴƋǔƍƸܱ଀ƠƯƍǔĭ Ꮑƕǜ
• %JKNF2WIJ$%ƷᏁೞᏡ̊‫ڒ‬༲൥ҕϠωνϨϱή‫܊‬ʀʀʀїҫྏंͺ؇ཀྵժ໚ͲePROMΝ
ϨΠϩν΢ϞͶࢂলͲ͘ΖΠϧʖφ௪எࢾ‫وͲݩ‬ఈ͠ΗͪΠϧʖφ௪எͶଲͤΖϓϫʖοϡʖφ*ePROMͺ‫ؠ‬ͶଲͤΖ੷‫ۅ‬ద࣑ྏ‫ؔغ‬ͺ‫ܩ‬କͤΖ*ҫྏंͶΓΖΠιηϟϱφ
yesnoEDC΃͹ཀྵ༟͹‫ࡎى‬no‫͠ं׳‬Ξ΃͹࿊ཙ͹චགྷ੓Ν൓இyes‫͠ं׳‬Ξ΃͹࿊ཙ
yesnoEDC΃͹ཀྵ༟͹‫ࡎى‬
EDC΃͹ཀྵ༟͹‫ࡎى‬*Πϧʖφ௪எ͖Δ72࣎ؔҐ಼Ͷ‫͠ं׳‬ΞͳαϱνέφΝͳΖ‫͠ं׳‬Ξ΃͹࿊ཙ‫ޛ‬͹ଲԢ• ు࿫Ͳ͹࿊ཙͲ ‫ܨ‬գ؏ࡱͲ ࢩ࣍ྏ๑༂͹ෲ༽ࢨࣖͲ ‫ྏ࣑޳ܨ‬༂౵͹ෲ༽஦ࢯࢨࣖͲ ͨ͹ଠ• णਏΝࢨࣖͲ ‫ࠬݗ‬͹ࣰࢬʤ݄ӹ‫ࠬݗ‬ɼժ଀‫ࠬݗ‬ʥͲ णਏ‫ޛ‬͹౦༂• णਏ‫ޛ‬͹ଲԢͲ ‫୒ؾ‬Ͳ ೘Ӆࣆྭ̏ҫྏं΃͹Πϧʖφ௪எʤ‫ܠ‬ଵΠϕϨɼE-mailʥ˖Πϧʖφ಼༲͹֮೟˖ࣆྭ̐ԠԞԙषးඡੳ

2022೧8݆31ೖ఼࣎ԠԞԙषးՔ‫؞ח‬՛‫ྫྷ׽‬ཐ໴ࣤඡੳӼӺӼӻႩԀଈ ⿤ ӼӺӼӼႩԂଈԟԡԞӷԚԞԣԏ‫׼‬՛‫״بװ״‬՛ԟԡԞӷԍԣԍԋԏӨಐৼᇠ षးඡੳ%/ुुुुुुुुϗʖηϧ΢ϱ2022೧8݆31ೖ఼࣎                        ૱਼         յ౶਼  ुुुुुղ೘‫܊‬ଲল‫܊‬֚౲঳ྭ਼೗͗Ξु ु ु ु ु ु ु ु ु ु ु ु ु ु ु ु ु ु ु ु   ुԟԡԞӷԍԣԍԋԏӨ֋‫ג‬೟ᇠ षးඡੳुพյ౶ི ुྈ‫܊‬഑͗Ξҥ͗Ξ୉ௐ͗Ξಆᰏ෨Ἱฑ৏ൿ͗Ξ،͗Ξࢢ‫ٸ‬ର͗Ξཝ૧͗Ξ͗Ξझพյ౶ི૱਼յ౶਼ʤ૱਼ʁ঳ྭ͟ͳ͹චགྷյ౶࣎‫਼غ‬͹࿪ʥ‫؞ח‬՛‫׽‬ᄇภඡੳԟԡԞӷԍԣԍԋԏषးಐ৖ॵյʀຘुʀࢾ‫ݩ‬श྅࣎ΉͲ૱਼ʤ݇ʥ ർིʤʥ૱յ౶Πϧʖφ൅ਫ਼࿊ཙᇓઍ֘‫֧׊‬ӡ଼෗௭Քᇤ‫ב׉‬ൊփ֥ணև֞඘஽Ӣ‫؞ח‬՛‫׽‬ᄇภӱ㕱ԁӧԀ² Ç Ԁᇀ֭㕱 ࿘ဗՔࡴ෗֭঵ೄ֔‫֌֣֪ג‬ՒԀഃ֪ӻष࿘ဗՒ‫؞ח‬՛‫׽‬ᄇภՓӡቴषးൊ֎ӢՔ֧֞և֯Ւ‫ץب؟״؀ؗ‬ૌ ֭঵ೄ֔‫ בג‬Ԁ኎ ࿘ဗ֓༶ဴ֖֞඘஽Ւӻഃ৖֪ӻष࿘ဗ֭‫؞ח‬՛‫ྫྷ׽‬ཐ ՓՔզᎌጛէ֮Ւ‫؞ח‬՛‫ྫྷ׽‬ཐ֭ዃӻӹӽӽഃ৖֪ӻष࿘ဗՒ঵ೄ֔‫ַג‬ᎌጛՓ࿊ཙ‫ޛ‬͹য়‫(ڱ‬෵਼յ౶)‫ܨ‬գ؏ࡱࢩ࣍ྏ๑༂಼ෲࢨࣖणਏࢨࣖ߇͗Ξࡐ಼ෲ஦ࢯͨ͹ଠ

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݃ ‫ޢ‬
z ePROMͺࠅ಼Ͳ΍ɼଡ͚͹खΕૌΊ͗࢟Ήͮͱ͕Εɼ‫ৼؖ‬ͺ߶͏
z ePROM͹໪దͺɼଡ༹੓Ͷ෍ΞͲ͏ΖͲ ༂෼ྏ๑͹෯ࡠ༽ϜϋζϟϱφΝ໪దͳͪ͢ePROM͗कླྀͲ ಝఈ͹༂෼ʀ༙֒ࣆেͶಝԿͪ͢ePROM
Ͳ ૥‫͗غ‬Ξ͹ึঁྏ๑ɼ఺Ңʀ࠸൅ྭ͹༂෼ྏ๑Ͳ ΠχϐΠϧϱηɼQOLɼਫ਼ଚ‫ؔغ‬Ͳ บஏʀ཯ౣҫྏ΃͹Ԣ༽ɼҫྏं͹ෝ୴ܲ‫ݰ‬z ࠅ಼͖Δ͹ePROMͶ‫ͤؖ‬ΖΦϑυϱη͹૓ड़͗‫غ‬ଶ͠ΗΖ

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