Bronchopulmonale dysplasie (BPD)

Initiatief: NVK Aantal modules: 25

Inhalatie NO bij BPD

Uitgangsvraag

Geeft het toedienen van iNO aan premature neonaten een reductie van het risico op BPD?

Aanbeveling

Sterk

De werkgroep raadt het gebruik af van iNO als behandeling om BPD te reduceren.

Overwegingen

Het bovenstaande bewijs ondersteunt de toediening van iNO aan prematuren in het kader van de preventie van BPD niet. Er is geen effect gevonden op zowel mortaliteit als BPD en dit geldt voor alle bestudeerde strategieën (vroeg bij oxygenatie problemen, later bij hoog risico op BPD of standaard). Een IPD-meta-analyse (Askie, 2011) keek naar het verschil in effect van iNO bij pasgeborenen met verschillende raciale achtergrond. Mogelijk zou er een groter effect van iNO in de preventie van BPD zijn bij kinderen met een Afro-Amerikaanse oorsprong. Vooralsnog is het resultaat van deze IPD-meta-analyse met name hypothese-genererend en is meer onderzoek nodig voordat de toediening van iNO in het kader van preventie van BPD aan deze specifieke patiëntengroep overwogen kan worden.

 

Het gebruik van iNO is kostbaar. In de aanbevelingen over iNO van het Pediatric Pulmonary Hypertension Network wordt het gebruik van iNO voor preventie van BPD bij prematuren pasgeborenen afgeraden, vanwege gebrek aan bewijs van effectiviteit (Kinsella, 2016). Op basis van al deze argumenten komt de werkgroep tot een negatieve aanbeveling. Verdere studies zijn nodig om te zien of een hogere startdosis iNO de uitkomst op BPD of overlijden zou kunnen verbeteren.

Onderbouwing

NO is een belangrijke endogene vasodilator en speelt tevens een wezenlijke rol bij neurotransmissie en bij afweer/immunologische reacties. NO, geproduceerd in endotheelcellen, katalyseert de omzetting van GTP naar c-GMP door activatie van het enzym sGC in de gladde spiercel. c-GMP zorgt voor het relaxerende effect in de spiercel, wat leidt tot vasodilatatie. NO kan via inhalatie/beademing worden toegediend (iNO) en leidt tot pulmonale vasodilatatie (daling van pulmonale tensie, stijging paO2). NO wordt toegepast bij pulmonale hypertensie als gevolg van RDS, meconiumaspiratie syndroom, (GBS-)sepsis, congenitale hartafwijkingen, chirurgische aandoeningen, zoals hernia diafragmatica, en exomphalos.

 

iNO is geopperd als behandeling ter preventie van longschade bij premature neonaten. Het effect en mechanisme van iNO op de longontwikkeling en BPD-gerelateerde longschade is in meerdere studies onderzocht. Toediening van NO doet de luchtwegweerstand afnemen, leidend tot een afname in zuurstofgebruik en beademingsdrukken, wat zou resulteren in minder oxidatieve stress, een normale longontwikkeling en alveolarisatie (Bland, 2005; Hamon, 2005; Martin, 2002). In dierenmodellen vermindert iNO hyperoxische schade (Cotton, 2006), verbetert endogene surfactant functie, en bevordert longgroei, angiogenese en alveolarisatie (McCurnin, 2005; Ballard, 2006a; Lin, 2005; Maniscalco, 2002; Tang, 2010). Daarbij speelt endogene NO een belangrijke rol voor een normale longontwikkeling. Prematuriteit is echter geassocieerd met een tekort aan endogene NO-productie en daarbij kan het toedienen van iNO als een vervangende therapie worden gezien. Dit heeft geleid tot meerdere internationale gerandomiseerde studies bij premature neonaten waarbij het effect van iNO werd onderzocht op de mortaliteit en/of BPD.

Matig

Toedienen van iNO <3 dagen na de geboorte bij respiratoir insufficiënte premature neonaten, met ernstige oxygenatieproblemen, geeft geen reductie van BPD.

 

Matig

Het toedienen van iNO <3 dagen na de geboorte bij respiratoir insufficiënte premature neonaten, met ernstige oxygenatieproblemen, verlaagt de mortaliteit niet.

 

Hoog

Het toedienen van iNO ≥3 dagen na de geboorte bij beademde premature neonaten met hoog risico op BPD geeft geen reductie van BPD.

 

Laag

Het toedienen van iNO ≥3 dagen na de geboorte bij beademde premature neonaten met hoog risico op BPD verlaagt de mortaliteit niet.

 

Hoog

Het routinematig toedienen van iNO bij beademde premature neonaten geeft geen reductie van BPD.

 

Matig

Het routinematig toedienen van iNO bij beademde premature neonaten verlaagt de mortaliteit niet.

 

Algehele kwaliteit van bewijs* = laag

*De algehele kwaliteit van het bewijs wordt bepaald door de cruciale uitkomstmaat met de laagste kwaliteit van bewijs.

Beschrijving literatuurselectie

In de eerste versie van de richtlijn werden 19 publicaties geselecteerd uit de search, waaronder twee recente SR’s (Askie, 2011; Barrington, 2010), 12 gerandomiseerde studies (Ballard, 2006b; Dani, 2006; Mercier, 2010; Hascoet, 2005; Kinsella, 1999 en 2006; [No authors listed], 1999; Schreiber, 2003; Su, 2008; Sunhedar, 1997; Van Meurs, 2005 en 2007), vier follow up studies (Hibbs, 2008; Walsh, 2010; Mestan, 2005; Patrianakos-Hoobler, 2011) en één economische evaluatiestudie (Zupancic, 2009). In de CR (Barrington, 2010) waren alle gevonden RCT’s geïncludeerd. In de IPD-based review van Askie (2011) waren drie studies niet meegenomen. De CR (Barrington, 2010) en IPD based (Askie, 2011) zijn de hoofddocumenten waarop de resultaten en conclusies zijn gebaseerd. Alleen de CR werd met GRADE beoordeeld, aangezien alle reviews tot dezelfde conclusie komen en de CR de meeste details weergeeft van de meta-analyse en resultaten. Follow-up studies en de economische evaluatiestudie zullen alleen worden meegenomen indien er effect van NO op BPD is aangetoond.

 

Bij de search voor de update werden 88 potentieel relevante studies gevonden, waaronder de update van de eerder geïncludeerde CR (Barrington, 2017). Hiervan bleken 63 studies duidelijk niet relevant. 22 artikelen werden om diverse redenen na het lezen van het abstract of het gehele artikel geëxcludeerd. De update van de CR en twee nieuwe RCT’s werden aan de eerder geselecteerde studies toegevoegd (Barrington, 2017; Hasan, 2017; Kinsella, 2014). Van deze nieuwe RCT’s is er één opgenomen in de CR (Kinsella, 2014), de andere verscheen later (Hasan, 2017). De data van Hasan (2017) werden echter voor publicatie gepresenteerd bij de Hot Topics in Neonatology in 2013. Deze preliminaire data werden wel meegenomen in de CR. Omdat de voor de richtlijn cruciale uitkomstmaten BPD en mortaliteit hierin zijn opgenomen en in het artikel van Hasan (2017) aanvullend met name de lange termijn neurologische uitkomstmaten worden gepresenteerd, wordt de studie van Hasan (2017) nu niet apart besproken.

 

NB. Bij meerdere RCT’s werden prematuren <34 weken AD geïncludeerd. Dit is voor deze PICO geaccepteerd.

 

Beschrijving studies

Cochrane review

In de CR (Barrington, 2010) werden 17 RCT’s geïncludeerd (totaal 4.065 patiënten) met steekproefgrootte variërend van 29 tot 900 patiënten (mediaan 96,5). Prematuren van verschillende zwangerschapsduur, gewicht en klinische condities werden geïncludeerd. Alle studies, op één na, onderzochten de populatie, zoals omschreven in de PICO (iNO versus geen iNO). Eén studie ([No authors listed], 1999) vergeleek vroege versus late start van iNO. In de studies werden patiënten geïncludeerd vanaf geboorte tot 27 dagen na geboorte. De dosis iNO varieerde in de studies van 5 tot 40 ppm, afhankelijk van response.

 

Omdat er grote verschillen waren in de inclusiecriteria bij de studies en de implicaties voor de praktijk zouden kunnen verschillen, werden de studies voor de meta-analyse in drie verschillende groepen verdeeld:

  • groep 1: geïncludeerd voor drie dagen, omdat de studies voldeden aan de oxygenatie criteria (tien trials);
  • groep 2: geïncludeerd na drie dagen in verband met verhoogd risico op BPD (drie trials);
  • groep 3: routine toepassen van iNO bij beademde patiënten (vier trials).

 

Askie

In deze review werden 11 van de 14 trials geïncludeerd (3.298 patiënten) voor analyse. De auteurs van resterende drie trials konden geen data aanleveren voor een IPD meta-analyse.

 

Bij alle drie de groepen meta-analyses werden de relevante uitkomstmaten bestudeerd: BPD bij 36 weken PML, mortaliteit bij 36 weken PML, deze twee uitkomsten gecombineerd, mortaliteit of neurologische follow-up en eveneens een combinatie van deze laatste twee uitkomsten. Voor deze richtlijn is alleen de CR met GRADE beoordeeld. De review van Askie (2011) bevat geen studies die niet ook in de CR zaten, dus was het overbodig beide te beoordelen.

 

Kwaliteit van het bewijs

Voor de kwaliteit van het bewijs is de meta-analyse van de CR gebruikt.

Groep 1: geïncludeerd voor drie dagen, omdat de studies voldeden aan oxygenatie criteria

De kwaliteit van het bewijs voor alle cruciale uitkomstmaten (BPD, overlijden bij 36 weken PML, gecombineerde uitkomst dood of BPD bij 36 weken PML en overlijden gedurende opname) was matig. Bij het merendeel van de studies was er een risico op bias voor alle uitkomstmaten, behoudens voor de uitkomstmaat overlijden bij 36 weken PML.

 

Groep 2: geïncludeerd na drie dagen in verband met verhoogd risico op BPD

De kwaliteit van het bewijs voor de uitkomstmaat BPD bij 36 weken PML was hoog. De kwaliteit van het bewijs voor de mortaliteit bij 36 weken PML was laag. Deze uitkomst is gebaseerd op twee studies waarvan er één voortijdig beëindigd werd in verband met 100% nadelige effecten, wat een risico op bias en imprecisie van de resultaten oplevert. De kwaliteit van het bewijs voor de gecombineerde uitkomst was matig door inconsistentie. De kwaliteit van het bewijs voor overlijden gedurende opname was matig, wederom door imprecisie van de resultaten.

 

Groep 3: routine toepassen van iNO bij beademde patiënten

De kwaliteit van het bewijs voor BPD bij 36 weken PML was hoog. De kwaliteit van het bewijs voor de mortaliteit bij 36 weken PML was matig door imprecisie van de resultaten. De kwaliteit van het bewijs voor de gecombineerde uitkomst BPD of mortaliteit was hoog. Voor overlijden gedurende opname was de kwaliteit van bewijs matig, wederom door imprecisie van de resultaten.

 

Gewenste effecten

De twee meta-analyses lieten geen significante verbeteringen zien op de uitkomstmaten BPD en/of mortaliteit (Barrington, 2017; Askie, 2011).

 

Cochrane

De analyses voor de drie verschillende groepen lieten bij alle groepen geen verbetering zien op de uitkomstmaat BPD bij 36 weken PML (groep 1: RR 0,89; 95% BI 0,76 tot 1,04; groep 2: RR 0,91; 95% BI 0,83 tot 1,01; groep 3: RR 0,95; 95% BI 0,85 tot 1,05).

 

De analyses voor de drie verschillende groepen lieten bij alle groepen geen verbetering zien op de uitkomstmaat mortaliteit bij 36 weken PML (groep 1: RR 0,89; 95% BI 0,72 tot 1,11; groep 2: RR 1,33; 95% BI 0,81 tot 2,20; groep 3: RR 1,31; 95% BI 0,90 tot 1,89).

 

De analyses voor de drie verschillende groepen lieten bij alle groepen geen verbetering zien op de gecombineerde uitkomstmaat BPD of dood bij 36 weken PML (groep 1: RR 0,94; 95% BI 0,87 tot 1,01; groep 2: RR 0,92; 95% BI 0,85 tot 1,01; groep 3: RR 0,94; 95% BI 0,87 tot 1,02).

 

De analyses voor de drie verschillende groepen lieten bij alle groepen geen verbetering zien op de uitkomstmaat mortaliteit gedurende ziekenhuisopname (groep 1: RR 1,02; 95% BI 0,89 tot 1,18; groep 2: RR 1,18; 95% BI 0,81 tot 1,71; groep 3: RR 0,90; 95% BI 0,74 tot 1,10) (Barrington, 2010).

 

Askie

De meta-analyse liet geen verbetering zien op de uitkomstmaat BPD (RR 0,93; 95% BI 0,87 tot 1,00), mortaliteit bij 36 weken (RR 1,05; 95% BI 0,93 tot 1,20), overlijden gedurende opname (RR 1,06; 95% BI 0,94 tot 1,2) en gecombineerde uitkomstmaat BPD of dood bij 36 weken PML (RR 0,96; 95% BI 0,92 tot 1,01).

 

Er waren geen statistisch significante verschillen in effect van NO voor elke subgroep (zwangerschapsduur, geboortegewicht, meerling, ras, antenatale steroïden, leeftijd bij randomisatie, oxygenatie index, PDA, pulmonale hypertensie, postnataal steroïden, gebruik van surfactant en type beademing) (Askie, 2011).

Analyse liet zien dat een startdosis van >5 ppm een reductie geeft van de kans op overlijden of BPD bij 36 weken PML (interactie p 0,02; RR 0,83; 95% BI 0,73 tot 0,95). Dit verschil is echter niet gezien bij andere doseringen. Daarbij zijn er studies die gestart zijn met lage dosis, waarbij de dosis werd opgevoerd op geleide van respons, en er waren studies waarbij met hoge dosis werd gestart en omlaag werd getitreerd. Daarbij is dit resultaat voornamelijk gebaseerd op één studie (Ballard, 2006b) waarbij met een dosis van 20 ppm werd gestart. Er waren echter meer verschillen in onderzoeksopzet aanwezig dan alleen de dosering die het effect op overlijden of BPD kunnen hebben veroorzaakt.

 

Ongewenste effecten

Vanwege het ontbreken van effectiviteit op de voor de werkgroep cruciale uitkomstmaten BPD, mortaliteit en de combinatie daarvan, werd geen analyse gemaakt van de ongewenste effecten. De follow-up studies en de economische evaluatie werden daardoor uiteindelijk niet gebruikt bij het opstellen van de aanbevelingen.

De volgende PICO werd opgesteld voor deze uitgangsvraag:

P Prematuren met een AD <32 weken.

I Toediening van iNO.

C Geen toediening van iNO.

O Incidentie van BPD, dood, gecombineerde uitkomst dood of BPD, lange termijn neurologische uitkomsten, bijwerkingen en kosten.

 

Er werd een systematische literatuursearch gedaan in Medline van 1995 tot augustus 2012. Deze search werd herhaald voor de update in 2019.

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Autorisatiedatum en geldigheid

Laatst beoordeeld  : 11-03-2021

Laatst geautoriseerd  : 11-03-2021

Geplande herbeoordeling  : 01-01-2027

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Kindergeneeskunde
Geautoriseerd door:
  • Nederlandse Vereniging voor Kindergeneeskunde
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
  • Verpleegkundigen en Verzorgenden Nederland
  • Care4Neo (voorheen Vereniging van Ouders van Couveusekinderen - VOC)
  • Longfonds

Doel en doelgroep

Doel

De doelen van deze richtlijn zijn:

  • het uniform en beter identificeren van patiënten met BPD;
  • formuleren van aanbevelingen ten aanzien van preventieve en therapeutische evidence-based behandeling;
  • het beter registreren van patiënten met BPD.

 

Doelgroep

De doelgroep omvat pasgeborenen met een verhoogd risico op BPD, namelijk prematuren met een AD <32 weken die nog niet de gecorrigeerde leeftijd van 36 weken hebben bereikt, maar wel pulmonale morbiditeit hebben. Dit uit zich in: beademingsbehoefte en/of CPAP-behoefte en/of extra O2-behoefte en/of hypercapnie en/of tachydyspneu. De doelgroep omvat eveneens zuigelingen met een vastgestelde BPD.

Samenstelling werkgroep

Kernwerkgroep

  • Mw. drs. M. van de Loo, kinderarts-neonatoloog, Emma Kinderziekenhuis Amsterdam UMC, NVK, projectleider
  • Dhr. prof. dr. A.H.L.C. van Kaam, kinderarts-neonatoloog, Emma Kinderziekenhuis Amsterdam UMC, NVK, voorzitter
  • Dhr. dr. W. Onland, kinderarts-neonatoloog, Emma Kinderziekenhuis Amsterdam UMC, sectie neonatologie, NVK

 

Werkgroep

  • Mw. M. Barnhoorn, projectleider, Longfonds
  • Mw. dr. A.C.M. Dassel, kinderarts-neonatoloog, Deventer Ziekenhuizen, sectie neonatologie, NVK
  • Mw. G. Hoekman, ouder, Longfonds
  • Dhr. dr. M.J.K. de Kleine, kinderarts-neonatoloog n.p., Care4Neo (voorheen VOC)
  • Dhr. dr. B.W.W. Kramer, kinderarts-neonatoloog, Maastricht Universitair Medisch Centrum sectie neonatologie, NVK
  • Dhr. dr. A. Kroon, kinderarts-neonatoloog, Erasmus MC – Sophia Kinderziekenhuis, sectie neonatologie, NVK
  • Mw. P.W. Mansvelt, verpleegkundig specialist, Radboudumc afdeling neonatologie, V&VN
  • Dhr. drs. P.R. Matthijsse, kinderarts-neonatoloog, Radboudumc, sectie neonatologie, NVK
  • Mw. dr. M. Pijnenburg, kinderarts-pulmonoloog, Erasmus MC en Sophia Kinderziekenhuis, sectie kinderlongziekten, NVK
  • Mw. drs. A.J. Sprij, kinderarts-neonatoloog, Hagaziekenhuis en locatie Juliana Kinderziekenhuis, sectie neonatologie, NVK
  • Mw. dr. R.N.G.B. Tan, kinderarts-neonatoloog, Willem-Alexander KJC en LUMC, sectie neonatologie, NVK
  • Mw. dr. J.L.E. Vrijlandt, kinderarts-pulmonoloog, Beatrix Kinderziekenhuis UMCG, sectie kinderlongziekten, NVK

 

Meelezer namens NVOG

  • Mw. dr. C.J. Bax, gynaecoloog-perinatoloog, Amsterdam UMC, NVOG

 

Met dank voor hulp en/of advies

  • Mw. Drs. E.J.S. Jansen, kinderarts-fellow neonatologie, Isala ziekenhuis Zwolle
  • Mw. H. Ahmed, student geneeskunde, Universiteit van Amsterdam
  • Dhr. prof. dr. R.M.F. Berger, kindercardioloog, Beatrix Kinderziekenhuis en UMCG

Belangenverklaringen

De werkgroepleden hebben een belangenverklaring ingevuld waarin zij hun banden met de farmaceutische industrie hebben aangegeven. De verklaringen liggen ter inzage bij de NVK.

Inbreng patiëntenperspectief

Het perspectief van patiënten/ouders wat betreft de zorg rondom BPD was in de eerste versie van de richtlijn gewaarborgd door een focusgroepbijeenkomst te hebben met ouders van patiënten met BPD. Daarnaast was in de werkgroep Care4Neo (voorheen de VOC) vertegenwoordigd. Voor de update van de richtlijn is de deelname van patiëntenvertegenwoordigers in de werkgroep verder uitgebreid. Naast een afgevaardigde van Care4Neo namen ook een ouder en een medewerker van het Longfonds deel aan de werkgroep. Er werd opnieuw een focusgroepbijeenkomst gehouden. Hier wordt meer in detail op ingegaan in de module 'Begeleiding ouders'.

Methode ontwikkeling

Evidence based

Implementatie

In de verschillende fasen van de ontwikkeling van het concept van de richtlijn is zoveel mogelijk rekening gehouden met de implementatie van de richtlijn en de daadwerkelijke uitvoerbaarheid van de aanbevelingen. De definitieve richtlijn is onder de verenigingen verspreid en via de website van de NVK en de Richtlijnendatabase elektronisch beschikbaar gesteld. Op wetenschappelijke bijeenkomsten van de betrokken wetenschappelijke verenigingen zijn de aanbevelingen van de richtlijn gepresenteerd. Verder zal er patiëntenvoorlichtingsmateriaal worden ontwikkeld ter ondersteuning van de richtlijn op de website thuisarts.nl.

Werkwijze

De ontwikkeling van de richtlijn BPD is gefinancierd door de SKMS. Gedurende de periode oktober 2011 tot september 2013 is aan de ontwikkeling van de eerste versie van de richtlijn gewerkt door leden van de (kern)werkgroep. Allereerst werd door de leden van de werkgroep een knelpuntenanalyse uitgevoerd om de huidige werkwijze ten aanzien van de diagnostiek en behandeling bij BPD in Nederland in kaart te brengen. Op basis van de resultaten van de knelpuntenanalyse werden met de werkgroep de uitgangsvragen opgesteld. Vervolgens werd per vraag een uitgebreid literatuuronderzoek uitgevoerd.

 

De update van de richtlijn werd gedurende de periode van mei 2018 tot mei 2020 geschreven. Omdat er een budget beschikbaar was voor de update van in totaal 13 uitgangsvragen, werd eerst door de werkgroep vastgesteld welke uitgangsvragen de hoogste prioriteit hadden voor de update. De werkgroep is er in geslaagd alle uitgangsvragen te updaten en twee nieuwe uitgangsvragen te ontwikkelen. Voor de update van de bestaande uitgangsvragen werd het literatuuronderzoek met de eerder gebruikte zoektermen herhaald om te zoeken naar studies die zijn verschenen na de ontwikkeling van de eerste versie van de richtlijn. Voor de nieuwe vragen werd een uitgebreid literatuuronderzoek gedaan.

 

Zoeken (inter)nationale richtlijnen

In eerste instantie werd gezocht naar evidence-based richtlijnen. Hierbij werd gebruik gemaakt van de volgende databases: National Guideline Clearinghouse, de GIN-database en Medline. Ook werd gezocht naar nationale medisch specialistische richtlijnen. De gevonden richtlijnen werden op kwaliteit beoordeeld door de kernwerkgroepleden met behulp van AGREE II (2013). De met AGREE vastgestelde domeinscores werden gebruikt als houvast voor de beoordeling van de richtlijn.

 

Zoeken artikelen

In de Cochrane database of systematic reviews, de DARE en het CCTR, beide eveneens van Cochrane, werd een algemene search uitgevoerd voor alle uitgangsvragen tegelijk. In Medline werd vervolgens een literatuursearch per uitgangsvraag of per set van uitgangsvragen uitgevoerd. Per uitgangsvraag werd beschreven welke zoektermen zijn gebruikt, welke zoekperiode en welke in- en exclusiecriteria werden aangehouden. Gedetailleerde informatie over de gebruikte zoektermen en de selectie van de artikelen is terug te vinden in de bijlage van de de richtlijn BPD.

 

Eerst werd gezocht naar de hoogste mate van bewijs: systematische reviews en gerandomiseerd en gecontroleerd onderzoek. Als dat niets opleverde werd verder gezocht naar observationele artikelen (prospectief en retrospectief cohortonderzoek en patiënt-controleonderzoek). Er werd niet gezocht naar onderzoek van een lager niveau van bewijs, zoals case studies en dierexperimenteel onderzoek. Alleen literatuur die voldoende valide en toepasbaar was, werd meegenomen in de richtlijn. Bij de resultaten is per uitgangsvraag de precieze PICO uitgeschreven en zijn specifieke aandachtspunten bij de methodiek toegelicht.

 

Beoordeling artikelen met GRADE

De methodologische kwaliteit van de geïncludeerde artikelen werd met de GRADE-methode beoordeeld om de kwaliteit van evidence transparant weer te geven. Aan het begin van het richtlijntraject werden uitkomstmaten gedefinieerd. Resultaten werden per uitkomstmaat samengevat, waarbij tevens de overall kwaliteit van de onderliggende bewijslast (evidence) werd aangegeven. Bij de beoordeling werd gebruik gemaakt van de software GRADE-pro. Met behulp van dit programma werd bij elke uitgangsvraag een tabel met bevindingen (summary of findings) en een tabel met de beoordeling van het bewijs (GRADE evidence profile) gemaakt. Deze tabellen zijn per uitgangsvraag te vinden in de Bijlagen bij de richtlijn BPD.

 

GRADE kent vier niveaus: high, moderate, low en very low. Per uitkomstmaat werd voor de kwaliteit van het bewijs met behulp van GRADE-pro een GRADE-niveau toegekend.

 

High ofwel hoog

Wanneer de kwaliteit van bewijs voor een uitkomst als high ofwel hoog geclassificeerd werd, wil dit zeggen dat het onwaarschijnlijk is dat toekomstig onderzoek de schatting van de uitkomst zal veranderen. Met andere woorden: er is veel vertrouwen in de juistheid van de schatting van de uitkomst.

 

Moderate ofwel matig

Wanneer de kwaliteit van bewijs voor een uitkomst als moderate ofwel matig geclassificeerd werd, wil dit zeggen dat het waarschijnlijk is dat toekomstig onderzoek effect heeft op het vertrouwen in de schatting van de uitkomst en zou de schatting van de uitkomst kunnen veranderen. Met andere woorden; er is matig vertrouwen in de juistheid van de schatting van de uitkomst.

 

Low ofwel laag

Wanneer de kwaliteit van bewijs voor een uitkomst als low ofwel laag geclassificeerd werd, wil dit zeggen dat het heel waarschijnlijk is dat toekomstig onderzoek effect heeft op het vertrouwen in de schatting van de uitkomst en zal deze schatting waarschijnlijk veranderen. Met andere woorden; er is beperkt vertrouwen in de juistheid van de schatting van de uitkomst.

 

Very low ofwel zeer laag

Een very low ofwel zeer lage classificatie wil zeggen dat er veel onzekerheid is over de juistheid van de uitkomst.

 

De onderzoeksopzet is een belangrijke factor binnen GRADE. Gerandomiseerde en gecontroleerde studies krijgen daarom in beginsel de kwalificatie hoog. Er zijn vijf factoren die kunnen zorgen voor een lagere kwalificatie:

  1. beperkingen in de onderzoeksopzet;
  2. inconsistentie: onverklaarde heterogeniteit van de resultaten;
  3. indirectheid: de populatie, interventie, controle en uitkomst (PICO) waarop de evidence gebaseerd is, wijken op een of meer punten af van de PICO die men wil onderzoeken. Ook het gebruik van surrogaatmarkers valt onder indirectheid;
  4. imprecisie: wijde betrouwbaarheidsintervallen rond een geschat effect duiden op onzekerheid in de grootte van het effect. Er is sprake van imprecisie bij een te kleine steekproef (lage statistische power), weinig gebeurtenissen (events) en een betrouwbaarheidsinterval dat wel statistisch significant is, maar zowel in het gebied van klinische relevantie als in het gebied van een verwaarloosbaar effect ligt;
  5. publicatiebias.

 

Observationele studies daarentegen krijgen in beginsel de kwalificatie laag. Er zijn drie factoren die kunnen zorgen voor een hogere kwalificatie:

  1. groot effect;
  2. aanwezigheid van dosisresponsrelatie;
  3. confounding die het werkelijke effect onderschat of een in werkelijkheid niet bestaand effect overschat.

Iedere beperkende of bevorderende factor kan leiden tot het verlagen of verhogen van de classificatie met een of twee niveaus. Indien de resultaten niet gepoold konden worden, werd volstaan met een globale inschatting van de kwaliteit van de onderliggende bewijslast. Voor een uitgebreidere beschrijving van GRADE verwijst de werkgroep naar https://www.gradeworkinggroup.org/ en het artikel van Guyatt (2008).

 

Bij de start van de ontwikkeling van de eerste versie van de richtlijn is er door de werkgroep voor gekozen om uitgangsvragen te beantwoorden die het gehele spectrum van BPD omvatten. Omdat dit meer uitgangsvragen opleverde dan door de epidemiologen die de richtlijn ondersteunden uitgewerkt konden worden, werden de vragen verdeeld over alle werkgroepleden. Voor een uniforme beoordeling door alle werkgroepleden van de kwaliteit van bewijs met behulp van GRADE-pro, werden de hieronder genoemde afspraken gemaakt.

 

Beoordelen van beperkingen in de onderzoeksopzet

Blindering interventie

Afgesproken werd altijd af te waarderen bij niet geblindeerd zijn van de interventie, ook als dit niet mogelijk was omwille van het soort interventie. Niet blinderen van de interventie kan in alle gevallen effect hebben op de resultaten van de studie. In iedere module werd in de paragraaf Van bewijs naar aanbeveling, indien nodig, meegenomen dat de kwaliteit van de evidence niet hoger kon vanwege de beperkingen opgelegd door het soort interventie en werd toegelicht waarom de werkgroep deze mening was toegedaan.

 

Blindering uitkomst

Indien de uitkomstmaat mortaliteit niet geblindeerd werd vastgesteld, werd hiervoor niet afgewaardeerd, omdat dit een harde uitkomstmaat is. Indien de uitkomstmaat BPD niet geblindeerd werd vastgesteld, werd wel afgewaardeerd.

 

Cumuleren beperkingen in de onderzoeksopzet (bias)

Indien er een tot twee beperkingen waren in de onderzoeksopzet, werd de kwaliteit van bewijs met één niveau afgewaardeerd. Indien er drie tot vier beperkingen waren in de onderzoeksopzet, werd de kwaliteit van bewijs met twee niveaus afgewaardeerd. Indien er onvoldoende informatie beschikbaar was in de studies om vast te stellen of er beperkingen waren in de onderzoeksopzet, werd de kwaliteit van bewijs afgewaardeerd, maar minder streng, dus niet alleen op basis van een onbekende factor van -1 naar -2 niveaus.

 

Beoordelen van imprecisie

Indien het aantal gebeurtenissen (events) <300 bedroeg, werd afgewaardeerd. Indien het 95% BI rondom het RR zowel geen effect als een klinisch relevant effect omvatte, werd eveneens afgewaardeerd. Het aantal gebeurtenissen boven de 300 is een kwaliteitscriterium dat in de neonatologie, met relatief kleine aantallen patiënten, in het merendeel van de studies niet gehaald wordt. Ook de door GRADE voorgestelde drempel van 25% voor een klinisch relevant effect werd als te hoog gezien. Omdat de beoordeling van imprecisie volgens deze criteria in de ogen van de werkgroep onevenredig bij kon dragen aan verlies van kwaliteit van de beschikbare studies, werd afgesproken slechts met één niveau af te waarderen voor imprecisie, ook als beide criteria niet voldaan waren.

 

Voor de update was geen epidemioloog beschikbaar in de werkgroep. Er werd gekozen om het herhalen van het literatuuronderzoek, het beoordelen van de kwaliteit van bewijs en het updaten van de richtlijntekst te laten uitvoeren door de leden van de kernwerkgroep. De overige werkgroepleden hebben aan de hand van de gevonden nieuwe literatuur bijgedragen aan het formuleren van de conclusies en de aanbevelingen. Voor het uitwerken van twee nieuwe uitgangsvragen werden de taken als volgt verdeeld: één vraag werd uitgewerkt door de patiëntenvertegenwoordigers in de werkgroep en één vraag werd uitgewerkt door de projectleider.

 

Van bewijs naar aanbevelingen

Tijdens voornamelijk telefonische vergaderingen van de werkgroep werd de evidence in de context van de dagelijkse praktijk besproken en werden de voor- en nadelen van de verschillende beleidsopties afgewogen. Voor het komen tot een aanbeveling zijn er naast het wetenschappelijk bewijs vaak andere factoren van belang, bijvoorbeeld: patiëntenvoorkeuren, beschikbaarheid van speciale technieken of expertise, organisatorische aspecten, maatschappelijke consequenties en veiligheid of kosten. Deze aspecten vallen onder de paragraaf Van bewijs naar aanbevelingen. De uiteindelijk geformuleerde aanbeveling is het resultaat van het beschikbare bewijs uit de literatuur in combinatie met deze aspecten.

 

De aanbevelingen zijn onder te verdelen in:

  • De werkgroep beveelt een interventie aan. Dit betekent dat de werkgroep van mening is dat het beschikbare bewijs voldoende is om alleen of in combinatie met andere aspecten, zoals eerder benoemd, te concluderen dat deze interventie zeker genoeg een positief effect oplevert voor de patiënt om aanbeveling te rechtvaardigen.
  • De werkgroep kan een interventie niet aanbevelen. Dit betekent dat de werkgroep van mening is dat er onvoldoende bewijs of overige aspecten zijn om zeker genoeg te zijn dat de interventie een positief effect oplevert voor de patiënt. Er is echter ook onvoldoende bewijs om de interventie af te raden.
  • De werkgroep raadt de interventie af. Dit betekent dat er ofwel in de ogen van de werkgroep voldoende bewijs is dat de interventie niet het beoogde effect zal opleveren, ofwel dat het effect onvoldoende bewezen is en de (potentiële) nadelen/bijwerkingen van de interventie niet opwegen tegen de kans op effect.

 

Bij iedere aanbeveling wordt verder aangegeven of het een sterke of een zwakke aanbeveling is. De sterkte van de aanbeveling wordt bepaald door de kwaliteit van het bewijs, de balans tussen gewenste en ongewenste effecten, het patiëntenperspectief, professioneel perspectief, middelenbeslag, organisatie van zorg en maatschappelijk perspectief. Toelichting bij de bepaling van de sterkte van de aanbevelingen is terug te vinden in de bijlage van deze module (zie Bijlagen bij de richtlijn BPD).

 

De werkgroep wil, wellicht ten overvloede, benadrukken dat alle aanbevelingen betrekking hebben op het effect van de interventie op de reductie van het risico op of op de behandeling van BPD. Over toepassen van interventies beschreven in de richtlijn voor andere indicaties dan BPD laat de werkgroep zich niet uit. Het is aan de behandelend arts om daarover te beslissen.

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