Cov friction ntawm classical thiab innovative kev tshawb fawb
Tus nqi rau kev tshawb fawb los ntawm ib tug pej xeem pej xeem mus rau lawv tus kheej muaj kev noj qab haus huv?? Puas yog ib txoj kev ua tau?, Uas muaj tus nqi rau kev kawm thiab cov neeg mob thiab yog cross-disease? Lub Cooperating Health Funds thiab Health Holland organise no nyob rau hauv 2017 Ib lo lus nug nyob rau hauv lub npe 'Zoo noj qab nyob zoo'. Lawv xaiv los ntawm ib pawg ntau tshaj 40 nkag ib consortium ntawm ob tog, Coj los Amsterdam UMC thiab Stichting Mijn Data Onze Gezondheid (MD|OG).
Yees duab: Liesbeth Dingemans
tswv yim: Tus nqi ntawm tus neeg mob nws tus kheej
Cov neeg mob muaj tau sim rau tej lub sij hawm los pab txhawb lawv rov qab rau hauv ib txoj kev qauv., Ntawm lwm yam los ntawm nws tus kheej xaiv kev cuam tshuam. Tus tsom ntawm tus consortium yog siv ib qhov nyiaj pab los tsim thiab kuaj ib tug tshiab kev tshawb fawb tshiab..
Nyob rau hauv qhov no, ob tug hais txog proposals merge: Yog ib tus AMC thiab lwm tus los ntawm tus neeg mob organisation MD|OG. Immunologist ntawm lub Amsterdam UMC Anje te Velde thiab thawj coj ntawm MD|OG Gaston Remmers: "Peb ob leeg tswv yim txog nrog ib tug qauv mus 'Kawm ntses' hauv lub hiav txwv ntawm cov ntaub ntawv thiab soj ntsuam tias cov neeg mob ua txhua hnub txog lawv kho mob.. Peb teem rau cov neeg uas muaj chronic fatigue., uas tseem muaj cov lus tsis txaus siab. Uas yog ib pawg loj ntawm cov neeg uas muaj kog tej kev cuam tshuam tam sim no., Thaum cov neeg no sim txhua yam, Piv txwv li, kom lawv lub nruab nrog cev tsis muaj zog."
Remmers tseem: "Tus qauv yuav twv tau npaj los pab kom paub kev loj hlob raws li kev xyaum ua tej yam tsim los ntawm pej xeem.. Cov neeg no yog inquisitive thiab sim tej yam tawm.. Txawm li ntawd los, zaum tsis tau siv feem coob ntawm cov thwmsim., Vim lawv tsis xav txog kev scientific txaus. Ntxiv thiab, cov pej xeem tsis haum rau cov raug randomized mus sib hais., feem ntau yuav tsum tau mus tshuaj ntsuam feem ntau. Qhov no yog tias nyob rau hauv xyaum ntau low-Harbor thiab uas yuav pab tau kev cuam tshuam tsis tau sij hawm, Thaum ntawm qhov tod tes, cov neeg mob tseem muaj teeb meem kev cuam tshuam."
neeg mob, Soj ntsuam ntawm, Tus lwm reviewers thiab cov financiers txais tos peb tes num tswv yim txog nrog fervent enthusiasm., Cov miv nyuas muaj siab.
Cov pab pawg neeg yuav ua hauj lwm los ua ib tug pov thawj-ntawm-tswvyim: Qhia tias kev tshawb fawb los ntawm ib tug pej xeem rau lawv tus kheej tsis zoo xwb muab insights rau lawv tus kheej, tab sis kuj rau kev paub txog txoj kev loj hlob.
Nyob rau hauv lub meantime, ib consortium loj consortium muaj emerged, Nqi financed los ntawm cov Cooperating Dutch Health Funds thiab Health Holland (Ib ceg ntawm ministry of Economic Affairs), yim neeg nyiaj txiag. Tus consortium consists ntawm plaub academic centres (Amsterdam UMC, Utrecht University, Tsev kawm ntawv ntawm Amsterdam thiab Maastricht University), tsib tuam txhab uas muag (Winclove Probiotics B.V., Springfield Nutraceuticals, Microbiome Center, Biovis Diagnostik, Danone/Nutricia Research) thiab ob tug pej xeem organisations (Stichting Mijn Data Onze Gezondheid thiab cov Holland Health Data Coöperatie). Peb tes num muaj ib tug dual coj, faib cov zaum thiab cov neeg mob: Amsterdam UMC (kev kawm txog yam xeeb) thiab Stichting Mijn Data Onze Gezondheid (neeg mob). Peb tes num muaj ib tug kws muaj txuj Scientific Board thiab ib tug neeg ua hauj lwm kws muaj txuj Board. Ua txhais tau tias,: Cov kev them nyiaj yug rau peb tes num yog siab heev.
"Peb yuav tau noj cov chij liab tiag lawm."
kev ua kom ib tug: Pej xeem kev kawm raws li ib qho ntxiv rau classical kev tshawb fawb
MijnEigenOnderzoek pib nrog ib pawg loj ntawm cov neeg uas muaj fatigue fatigue thiab intestinal tsis txaus siab. Vim hais tias nws tsis yooj yim rau koj ntiv tes rau ntawm qhov chaw mob, Ntau cov kws kho mob tsis paub yuav ua li cas nrog cov neeg mob. Meanwhile, cov neeg feem coob taug kev xyoo nrog lawv cov lus tsis txaus siab thiab sim txhua yam tawm., xws li probiotics. Muaj cov scientifically muaj zog indications tias qhov zoo tshaj ntawm cov flora flora yog hais txog fatigue. Kom deb li deb, nws muaj proved nyuaj mus nrhiav kom tau ib qhov txuas, Vim muaj ntau txoj kev sib tshuam. Classic randomized thiab placebo-tshuaj mus sib hais thiaj li tsis muab ib daim duab tseeb. Nws yog ib qho nyuaj heev los tsim kom muaj qhov nruab nrab causality thiab nyhuv., Thaum soj ntsuam ntawm ua observe loj sib txawv loj nyob rau hauv cov teebmeem ntawm tus neeg theem.
Common randomised tshuaj mus sib hais (RCTs) sim txo cov yam ntxwv interacting yam rau ib tug tswj thiab standardized number. Vim hais tias cov kev tshawb fawb ntawm cov kev tshawb fawb no muaj cov neeg mob me ntsis, MijnEigenOnderzoek proposes ib lwm foupective: Pub complexity nyob ua ib ke thiab cov ntaub ntawv relevant parameters. Tsis pub dhau txoj kev no, lub hom phiaj no tsis heev muab pov thawj tam sim ntawd rau nyhuv., Peb tes num aims los ua kom muaj ib txoj kev structured los ua kom muaj hypotheses kom paub meej tias raws li kev tshawb fawb.
Rau qhov kawg no, tus consortium yog tsim txoj kev nyob rau hauv peb cov kauj ruam fundamental.:
Ib robust xyuas lawv: Tus neeg mob-soj ntsuam ntawm xaiv ib qho kev cuam tshuam nyob rau hauv cov kev taw qhia ntawm ib tug kws kho mob. Lawv txhais lawv tus kheej relevant sij hawm ntsuas thiab khaws lawv nyob rau hauv ib app
Ib cov ntaub ntawv tsom xam kom paub homogeneous subgroups ntawm sib 'responders' thiab 'tsis-responders'
Ib classical randomized mus sib hais ntawm ib tus nrhiav subgroups los objectify cov nyhuv assumed nyhuv ntawm ib qhov kev cuam tshuam
Qhov no ua rau txoj kev conclusive thiab MijnEigenOnderzoek muab cov pov thawj-ntawm-tswvyim rau ib txoj kev zoo ntawm kev tshawb fawb nrog kev tshawb fawb uas cov neeg xaiv thiab saib lawv tus kheej.. Ib tug piv txwv zoo ntawm pej xeem kev kawm.
Nyob rau hauv lub elaboration ntawm lub tswvyim proof-of-concept, nws zoo nkaus li tias muaj ib txoj kev soj ntsuam raws li txoj cai los ntawm ib pawg neeg kho mob-ethical xyuas pawg neeg. (metc) tsim nyog. Pawg neeg nrees rejects tus thawj tswv yim txog. Thiaj li yuav kos tau lub tswv yim txog revised tswv yim txog, cov pab pawg neeg yuav txawj ntau txuam yuaj rua kev sib tham nrog lwm MREC., nws yog ib qho txawv heev. Feem ntau MREC siv tau ib lub tswv yim txog, ntsuam xyuas tias, muab feedback thiab uas yog nws. Piv txwv li, lawv sim koom tes thiab nug cov MREC. Inhibitors: "Peb xav tau razor ntse: Yog peb tsis tau kev tso cai ces tsawg kawg yog ib qho kev soj ntsuam substantive. "Peb mam li tuaj rov qab nrog ib tug ntse heev ob tswv yim txog.. Peb xa qhov no mus rau lwm MREC., Vim peb tej paternalism txog tus neeg mob foupective ntawm tus thawj METC."
"Ua ib soj ntsuam, tsis txhob ntshai lo koj caj dab tawm. Hais twj ywm: tsawg kawg yog rau cov neeg mob."
tshwm sim: Irreconcilable foupectives tua kuv tus kheej kev tshawb fawb
Lub luag hauj lwm ntawm ib MREC proves unwavering: Inhibitors: "Thaum kawg, peb yuav tsum haum rau xwb ob txoj kev xaiv.: los yog koj tig nws mus rau hauv ib ntshiab RCT, xws li koj opt rau kev tshawb fawb soj ntsuam. Thaum peb xav innovate nyob rau hauv cheeb tsam no., Peb yuav tsum tuaj nrog ib tug sib xyaw."
Txawm li ntawd los, tus thib ob MREC kuj rejects, Muaj kev paab kim heev. "Peb xav hnov tias ib methodologically txawv set-up sai seb puas tsimnyog tau cov lus nug txog sab ethical.," Tseem Remmers. "Peb pib ntawm ib tug ethic txawv, Uas kuj yuav tsum tau ib txoj kev sib txawv methodology. Lub tswv yim prevailing txog qhov no, Txawm li cas respectable ntawm tus pom ntawm ib MREC, tua peb txoj kev."
Ib xyoos thiab ib nrab hnub tom qab, Tom qab ob tug tsis tau tejyam me nyuam no yuav tau tso cai los ntawm kev kho mob ethics xyuas pawg neeg, funders thiab consortium nrog ib tug neeg txiav txim siab los discontinue peb tes num. Cov tensions ntawm cov consortium nrog ib tug neeg thiab kev soj ntsuam pawg neeg muaj proved ib yam nkaus thiab.. Lawv tsis tau nrhiav sib hauv lawv views thiab kev txhawj xeeb txog ethics., methodology thiab kev noj qab haus huv. Peb tes num xav tias nws tau pom muaj ib txoj kev incompatible notions rau ntau theem., Tab sis nws twb tsis tau transcend lub paradoxes.
MijnEigenOnderzoek muaj yielded ob sab zoo los tom qab siv ceev xwmphem.
Anje Te Velde tau txais ib pob nyiaj siv los ntawm cov Amsterdam UMC mus taw ib soj ntsuam ntawm txoj kev kawm. Nws yog tam sim no researching fatigue hauv IBD (mob rau hauv cov hnyuv), Qhov twg cov soj ntsuam ntawm noj questionnaires los ntawm cov neeg mob los txiav txim seb lawv nkees thiab kos ntshav rau immunological thwmsim. Li ntawd, qhov no yog hais txog ib nam ntawm txoj kev tshawb fawb ntawm MijnEigenOnderzoek. Txoj kev soj ntsuam tswv yim txog muaj tam sim no tau pom zoo los ntawm pawg neeg ethics pawg neeg.
Gaston Remmers tam sim no ua haujlwm part-time thaum lub tsev kawm ntawv ntawm Twente. Nws txhim kho cov neeg mob lwm tus pej xeem kev kawm: Li cas koj yuav txuas cov ntaub ntawv thiab kev tshawb fawb los ntawm 'laymen' nrog ua hauj lwm thiab tus nqi thiab txuam yuaj rua cov peev xwm investigative peev xwm ntawm pej xeem? Ib feem ntawm nws tes hauj lwm yog ntxiv deepen txoj kev thiab soj ntsuam ntawm MijnEigenOnderzoek.. Tsis tas li, raws li tus coj ntawm Stichting Mijn Data Onze Gezondheid tus paub txheej txheem 'Kev tshawb fawb los ntawm thiab rau cov neeg mob' muaj tau twv., Nyob rau hauv kev koom tes nrog lwm tus neeg organisations thiab rau ZonMw. Thaum kawg, PublicScience2Health yug, Ib lub teb chaws platform ntawm nws tus kheej investigating zej zog nyob ib ncig ntawm kev noj qab haus huv nrog tej lub 15 affiliated cov pab pawg neeg uas ua ke sawv ntsug rau 10.000 Neeg.
Lub Microbiome Center, Yog ib tus consortium nrog ib tug neeg, Tau ua ib lub innovative infrastructure rau kev kho thiab kev tshawb fawb rau lub foundations uas lub mindset ntawm MijnEigenOnderzoek tau tsim. Cov tshuaj personalized yog tauj muaj, Nrog lub ntiaj teb no ntau yam probiotic components, txuas rau koj tus kheej xyuas. Tam sim no muaj ntau tshaj 3000 Cov neeg mob kho thiab muaj ib tsab ntawv concurring los ntawm ib tsab ntawv MREC siv cov ntaub ntawv rau retrospective kev tshawb fawb.
Cov tshooj lus kawm: Unruly nyuas txog ethics thiab methodology
Kom cov receptivity rau hom kev tshawb fawb no, Kev sis caav sib cav tswv yim ntawm cov neeg thiab organisations rau cov teeb meem no yuav tsum tau. Lub tswvyim mas innovative tswvyim ntawm MijnEigenOnderzoek muaj ntau standing assumptions txog methodology, ethics thiab tus neeg mob khu nyob rau hauv kev tshawb fawb muab tso rau hauv ib lub teeb tshiab.
"Tib lub sijhawm, peb yuav tau noj cov chij liab tiag lawm., Vim lawv muaj heev ntxov heev rau.", Hais te Velde. "Thaum pib, peb twb tau txais teeb liab tias cov pawg neeg ethics wondered seb cov neeg ntawm cov AMC yuav tsum xav coj lub luag hauj lwm rau 'irresponsible txoj kev'., quackery thiab tsev kws kho mob'." Inhibitors: "Peb tswv yim yog precisely los tiv thaiv quackery thiab tsev-docking., uas yuav siv sij hawm lawm, ntaub pua txaj. Peb muaj overestimated peb tus kheej hauv peb muaj peev xwm fim no lus ceeb toom., Peb yuav tsum tau gained zoo txawj ntse sai." Te Velde ntxiv: "Tib lub sijhawm, kuv xav tias tam sim no: Raws li ib tug soj ntsuam, tsis txhob ntshai lo koj caj dab tawm. Txawm tias neeg nyob hauv cheeb tsam xav tias nws tseem tsis tau koj qhov chaw, Hais twj ywm: tsawg kawg yog rau cov neeg mob."
Saib rov qab, Remmers qhia: "Raws li consortium nrog ib tug neeg, peb tau paub zoo txog txoj kev sib tw systemic., Tab sis peb cherished lub vam cia tias peb tes num yuav transcend nws. Peb muaj overlooked nws toughness thiab nws cov neeg, Thiab tau nyob rau hauv ib tug txiav txim zoo naïve".
"Txoj kev ntawm peb tes num yog lossi confronted nrog lawv nam.. Qhov no yuav tsum tau ua nrog lub nyuas kev tshawb fawb thiab sawv views ntawm ethics thiab methodology.. Cov no muab tsis tau bridgeable nyob rau lub sij hawm uas cov kev tshawb fawb tau muab.", hais remmers.
Inhibitors: "Txoj kev ntawm MijnEigenOnderzoek yog visionary, Tab sis mus rau comprehension, competences thiab paradigms ntawm rov xyuas lub cev tshaj ntawd. Qhov tseem ceeb tshaj plaws tam sim no yog coj cov ntsiab lus sanding saum lub rooj thiab maj mam ua hauj lwm lawv.. Rau qhov no, nws muaj kev koom tes ntawm cov koom haum uas cov koom haum, tub ceev xwm, Zaum thiab financiers indispensable."
Muaj yeej yuav tsum tau hloov hauv txoj kev ZonMw, HealthHolland thiab lwm ob tog qhov teeb meem lawv hu rau kev tshawb fawb. Inhibitors: "Nyob rau hauv innovative approaches qhov twg ethics, methodology thiab kev ua si ib lub luag hauj lwm, Nws yuav tsis txaus los tsim nyiaj thiab ces khi rau incumbent xyuas. Hom lawv innovation yuav tsum tau muaj kev kuaj xyuas ntawm cov ntsiab lus ntawm friction., ceev tau lub voj voog."
Tus Einstein taw tes (soj ntsuam txog complexity): Nws tau yooj yim xyoo kom nyuab, soj ntsuam heev heterogeneous tus neeg mob. Cov tsis muaj insights tshiab rau cov neeg mob tau coj mus kev sib nrig sib tsis pom kev zoo alignment ntawm lub koom haum los tsoo kev tshawb fawb nyob rau hauv ib txoj kev tshiab..
Lub canyon (ingrained qauv): Cov kev kho mob Ethical review Committee (metc) Pom RCTs raws li tus holy grail ntawm kev tshawb fawb txog kev tshawb fawb uas kev tshuaj ntsuam yuav tsum tau raws li. Tu siab lub CONVICTIONS ntawm lub MREC twb tsis lov nrog cov kev tshawb fawb tam sim no., muaj zog heev.
Qhov chaw ntawm lub rooj (Tsis yog txhua ob tog koom tes nrog): Tus organisations koom tes nrog MijnEigenOnderzoek thiab pab neeg no uas ua no consortium, tsis tau muaj xws li cov METC nyob rau hauv peb tes num pib. Txawm li ntawd los, lawv tau ua qhov txawv los hloov txoj kev txheej txheem ntawm cov MREC los cia li ntsuam xyuas proposals rau ntau nqi creation..
Tus ncej-nws (lub hwj huam ntawm serendipity): Txawm hais tias pab neeg no ua tus consortium tau ua nquag kev txiav txim siab uas contributed rau lub sij hawm disappointing, Pab neeg no puas tau muaj kev teebmeem tom qab siv ceev xwmphem MijnEigenOnderzoek. Piv txwv li, ob tug kev tshawb fawb scientific tau pib los ntawm ib tug neeg pab neeg uas peb tes num ua ib tug tib neeg ncaj qha.
