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Periconception endogenous and exogenous maternal sex steroid hormones and risk of asthma and allergy in offspring: protocol for a systematic review and meta-analysis

Talovic, Merhumisa,Sheikh, Aziz,McCleary, Nicola,Erkkola, Marjaliisa,Kaila, Minna,Virtanen, Suvi,Nwaru, Bright I

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1 Talo icM, e al. BMJ Open 2017;7:e014637. doi:10.1136/bmjopen-2016-014637 Open Access Abs Ac In oduc ion P egnancy is associa ed wi h se e al ho monal changes which in luence he de eloping e us. Va ia ions in ma e nal endogenous ho mones and p ep egnancy use o ho monal p epa a ions ha e been linked o as hma and alle gy in he o sp ing, bu indings a e inconsis en . We plan o unde ake a sys ema ic e iew o syn hesise he e idence on he associa ion be ween endogenous and exogenous ma e nal sex ho mones and he isk o as hma and alle gy in he o sp ing. Me hods and analysis We will sea ch Medline, Embase, Coch ane Lib a y, Ins i u e o Scien i ic In o ma ion Web o Science, Cumula i e Index o Nu sing and Allied Heal h, Scopus, Google Schola , Allied and Complemen a y Medicine Da abase, Global Heal h, Psychological In o ma ion (PsycINFO), Cen e o Ag icul u e and Bioscience (CAB) In e na ional and WHO Global Heal h Lib a y om incep ion un il 2016 o iden i y ele an s udies on he opic. Addi ional s udies will be iden i ied by sea ching da abases o p oceedings o in e na ional con e ences, con ac ing in e na ional expe s in he ield and sea ching he e e ences ci ed in iden i ied s udies. We will include analy ical epidemiological s udies. Two esea che s will independen ly sc een iden i ied s udies, unde ake da a ex ac ion and assess isk o bias in eligible s udies, while a hi d e iewe will a bi a e any disag eemen . We will use he E ec i e Public Heal h P ac ice P ojec ool o assess he isk o bias in he s udies. We will pe o m a andom-e ec s me a-analysis o syn hesise he e idence. We will use he G ading o Recommenda ions Assessmen , De elopmen and E alua ion app oach o a e he s eng h and quali y o he o e all e idence wi h espec o each ou come. E hics and dissemina ion E hical app o al is no equi ed since he s udy is a sys ema ic e iew o published li e a u e. Ou indings will be epo ed in a pee - e iewed scien i ic jou nal. PROSPERO egis a ion numbe CRD42016048324 In oduc Ion P egnancy is associa ed wi h nume ous adjus - men s ha occu in he endoc ine sys em, which a e no mal and necessa y adap a ions ha adequa ely accommoda e he e us.1–5 These adjus men s include oes ogen and p oges e one ho monal changes, which see s eady le els o inc ease and a e essen ial in supp essing he hypo halamic axis and he mens ual cycle.1–5 Human cho ionic gonad- o opin also inc eases and helps o sus ain he p oduc ion o p oges e one by he co pus lu eum.4 5 P olac in le els inc ease as a esul o he ma e nal pi ui a y gland. Ad enal ho mones such as co isol and aldos e one inc ease, as do pa a hy oid ho mones, which lead o g ea e up ake o calcium in he gu and eabso p ion in he kidney.1–5 Oes ogen plays a key ole in he well-being and de elopmen o he e us.4 5 Inc eases in he le els o p oges e one p oduc ion help o elax b onchiola smoo h muscle and a e associa ed wi h an inc ease in minu e en ila- ion, which can ise o up o 50% g ea e han p ep egnancy le els.4 5 Bo h oes ogen and p oges e one a e hough o ac as immuno- s e oids, al hough he e ec on he di ec ion Pe iconcep ion endogenous and exogenous ma e nal sex s e oid ho mones and isk o as hma and alle gy in o sp ing: p o ocol o a sys ema ic e iew and me a-analysis Me hunisa Talo ic,1 Aziz Sheikh,1 Nicola McClea y,1 Maijaliisa E kkola,2 Minna Kaila,3 Su i M Vi anen,4,5,6,7 B igh I Nwa u1,4 o ci e: Talo icM, SheikhA, McClea yN, e al. Pe iconcep ion endogenous and exogenous ma e nal sex s e oid ho mones and isk o as hma and alle gy in o sp ing: p o ocol o a sys ema ic e iew and me a-analysis. BMJ Open 2017;7:e014637. doi:10.1136/ bmjopen-2016-014637 ►P epublica ion his o y and addi ional ma e ial o his pape a e a ailable online. To iew hese iles please isi he jou nal online (h p:// dx. doi. o g/ 10. 1136/ bmjopen- 2016- 014637). Recei ed 16 Oc obe 2016 Re ised 15 May 2017 Accep ed 24 May 2017 Fo numbe ed a ilia ions see end o a icle. Co espondence o Me hunisa Talo ic; me hunisa. alo ic@ gmail. com P o ocol S eng hs and limi a ions o his s udy ►This is he i s sys ema ic e iew examining he ole o endogenous and exogenous ma e nal sex s e oid ho mones and isk o as hma and alle gy in he o sp ing and hus will con ibu e o knowledge on he e al o igin o alle gy and as hma. ►We will iden i y s udies om majo heal hca e da abases wi hou using geog aphical o language limi a ions, as well as including an ex ensi e e iew on all o he cu en li e a u e, ongoing and unpublished s udies and will employ eplicable me hods. ►Exis ing s udies may be he e ogeneous, hus making i di icul o de i e pooled es ima es om included s udies. g oup.bmj.com on Sep embe 5, 2017 - Published by h p://bmjopen.bmj.com/Downloaded om 2Talo icM, e al. BMJ Open 2017;7:e014637. doi:10.1136/bmjopen-2016-014637 Open Access o shi in he T cells is no en i ely clea .4 5 Howe e , i has been sugges ed ha he obse ed changes in le els o ma e nal endogenous sex s e oid ho mones, including oes ogen, p oges e one and es os e one, du ing p eg- nancy may in luence subsequen isk o as hma and alle gy in he o sp ing.6–9 P ep egnancy use o o al con acep i e pills, including combined pills and p oges in-only pills, has been pos u- la ed o modula e he isk o as hma and alle gy in he o sp ing h ough possible dis up ion o he immunolog- ical balance.10–16 Wjs and Dold we e he i s o pos ula e ha he use o con acep i e pills be o e p egnancy may in luence subsequen isk o as hma and alle gy in he o sp ing.10 Acco ding o hei hypo hesis, he e ec o con acep i e pills may las o se e al yea s e en a e discon inua ion; howe e , he dosage, equency and iming o use o o al con acep i e pills which may ins iga e he immune e ec ha can esul in inc eased o sp ing as hma and alle gy isks a e unclea .10 Al hough se e al s udies ha e now in es iga ed he ole o bo h endogenous and exogenous sex s e oid ho mones du ing p egnancy in he de elopmen o as hma and alle gy in he o sp ing, indings a e inconsis en . To cla i y he unde lying e idence base, we plan o unde - ake a sys ema ic e iew o iden i y, c i ically app aise and syn hesise s udies on he ole o changes in endogenous sex s e oid ho mones du ing p egnancy and he ole o exogenous s e oid ho mone use be o e p egnancy in he de elopmen o as hma and alle gy in he o sp ing. Me hods This p o ocol is epo ed ollowing he ecommenda ions o he P e e ed Repo ing I ems o Sys ema ic e iew and Me a-Analysis P o ocols (PRISMA-P) checklis .17 eligibili y c i e ia Types o s udies All analy ical obse a ional epidemiological s udies: coho s udies, case con ol s udies and c oss-sec ional s udies on he opic a e eligible o inclusion. Animal s udies, case se ies, case s udies and e iews will be excluded. Pa icipan s We a e in e es ed in he ole o changes in endogenous sex ho mones and in he use o exogenous sex ho mones in he yea be o e p egnancy and du ing p egnancy. We will he e o e include women du ing p econcep ion and p egnancy and hei o sp ing o any age. Yea s conside ed We will include s udies published om he incep ion o each da abase sea ched un il he end o 2016. Language We will ha e no language es ic ions and we will endea ou o ansla e li e a u e published in languages o he han English whene e his is possible. In o ma ion sou ces Da abase sea ches and o he sou ces o iden i y s udies To iden i y ele an s udies, we will sea ch Medline, Embase, Coch ane Lib a y, Ins i u e o Scien i ic In o ma- ion (ISI) Web o Science, Cumula i e Index o Nu sing and Allied Heal h, Scopus, Google Schola , Allied and Complemen a y Medicine Da abase, Global Heal h, Psychological In o ma ion (PsycINFO), Cen e o Ag i- cul u e and Bioscience (CAB) In e na ional and WHO Global Heal h Lib a y. Addi ional e e ences will be iden- i ied by sea ching he e e ences ci ed in eligible s udies; by sea ching da abases o he p oceedings o in e na- ional con e ences, such as ISI Con e ence P oceedings Ci a ion Index ia Web o Science, Ze oc B i ish Lib a y's Elec onic Table o Con en s (ZETOC) and by con ac ing a panel o in e na ional expe s and au ho s who ha e published in he ield. We will sea ch ial egis ies, such as Cu en Con olled T ials (h p://www. con olled- ials. com), ClinicalT ials. go (h p://www. clinical ials. go ), and Aus alian and New Zealand Clinical T ials Regis y (h p://www. anzc . o g. au) o iden i y ongoing s udies. Sea ch s a egy We ha e p epa ed a sea ch s a egy using he O id in e - ace o Medline (see online supplemen a y appendix 1) o iden i y and e ie e ele an s udies. We will adap his sea ch s a egy when sea ching he o he da abases. s udy eco ds Da a managemen We will use Endno e Lib a y o managing he e e ences iden i ied om he da abases. All eco ds will be expo ed o Endno e Lib a y o onwa d s udy sc eening, de-dupli- ca ion and o e all managemen o he e ie ed eco ds. Selec ion p ocess Two e iewe s (MT and NM) will independen ly sc een he i les and/o abs ac s and ull ex s o po en ially eligible s udies. A hi d e iewe (BN) will a bi a e any disag eemen s. Da a ex ac ion Two e iewe s will independen ly ex ac ele an s udy da a om eligible s udies on o a cus omised da a ex ac ion o m, while a hi d e iewe will a bi a e any disc epancies. The da a ex ac ion o m will be pilo ed using a selec sample o he eligible s udies p io o use in ex ac ing da a om all s udies. Da a i ems We will p oduce desc ip i e summa y ables o summa ise eligible s udies. All ele an s udy da a will be abula ed and as a minimum he ables will include he ollowing: s udy au ho , coun y o s udy, yea o publica ion, s udy design, size o s udy popula ion, sou ce o s udy popula- ion, ype o exposu e s udied (endogenous s exogenous sex ho mones and he speci ic ypes) and me hod o assessmen , ime be o e p egnancy and imes e du ing g oup.bmj.com on Sep embe 5, 2017 - Published by h p://bmjopen.bmj.com/Downloaded om 3 Talo icM, e al. BMJ Open 2017;7:e014637. doi:10.1136/bmjopen-2016-014637 Open Access p egnancy exposu e was asce ained, leng h o ollow-up ( o ollow-up s udies), con ounding ac o s conside ed, s udy ou comes and me hods o assessmen , analysis me hods and key esul s. The PRISMA checklis will guide he epo ing o he sys ema ic e iew.18 Types o exposu es We will include s udies ha ha e in es iga ed he ole o all ele an endogenous sex s e oid ho mones (including oes ogen, p oges e one, es os e one) and exogenous sex ho mones (including oes ogen only, p oges e one only and combined o al con acep i es). Ou comes and p io i isa ion Ou p ima y ou comes will include: objec i ely measu ed o sel - epo ed as hma, a opic de ma i is/eczema, alle gic hini is, anaphylaxis, u ica ia, angioedema and ood alle gy. The seconda y ou comes will include: a opic sensi isa ion as de ined ei he by skin p ick es o aised an igen speci ic IgE; objec i e and subjec i e measu es o disease se e i y and impac on quali y o li e, including as hma exace ba ions, use o as hma medica ions, hospi- alisa ion o as hma, wheeze as de ined by sel - epo o objec i e diagnosis; indica o s o ai way unc ion including (peak expi a o y low, o ced expi a o y olume in 1 s, o ced i al capaci y, o ced expi a o y low a e o al e na i e age app op ia e pulmona y unc ion es s (oscillome y o exhaled ni ic oxide analysis)) and measu es o pa ien - epo ed heal h- ela ed quali y o li e ela ed o as hma o alle gy. We will also assess he impac o sex ho mones on any alle gic o espi a o y ou come. Risk o bias in indi idual s udies Two e iewe s (MT and NM) will independen ly e alua e he isk o bias in eligible s udies and consensus will be eached h ough discussion; a hi d e iewe (BN) will a bi a e any disc epancies. We will use he E ec i e Public Heal h P ac ice P ojec ool (EPHPP) (www. ephpp. ca) o app aise he isk o bias in s udies. The EPHPP ool allows o he g ading o key componen s o he s udies, including: sui abili y o he s udy design o he esea ch ques ion; isk o selec ion bias; exposu e measu emen ; ou come assessmen (gi ing a highe g ade o objec i ely de ined ou comes han subjec i ely de ined ou comes) and gene alisabili y o indings. F om hese compo- nen -speci ic g adings, we will de i e an o e all g ading o each s udy. Da a syn hesis All analyses will be unde aken sepa a ely o s udies on exogenous ho mones and s udies on endogenous ho mones. We will syn hesise he da a bo h na a i ely and quan i a i ely. Fo quan i a i e syn hesis, we will pe o m andom-e ec s me a-analysis o combine he es ima es om s udies judged o be clinically, me hodologically and s a is ically homogeneous. He e ogenei y be ween s udies will be quan i ied using he I2 s a is ic. Fo anal- yses in es iga ing he ole o endogenous sex ho mones, da a syn heses will be unde aken by p egnancy imes e . Subg oup analyses will be pe o med acco ding o age o o sp ing a onse /diagnosis o ou comes (whe e possible using he ollowing age g oups: <5 yea s, 5–12 yea s, >12 yea s), sex, pa i y and o analyses in es iga ing he ole o exogenous sex ho mones, ime o exposu e be o e p egnancy (eg, 6 mon hs s 12 mon hs be o e p egnancy). Using he g ading de i ed om he quali y app aisal o eligible s udies, we will pe o m sensi i i y analyses o e alua e he obus ness o ou indings and whe he hey a e in luenced by he isk o bias in s udies. The me a-analyses will be pe o med using he s a is ical package S a a V.14. Publica ion bias We will e alua e he po en ial o publica ion bias by using unnel plo s and Begg and Egge es s.19 20 con idence in he cumula i e es ima e We will e alua e and g ade he s eng h and quali y o he o e all e idence emana ing om he e iew using he G ading o Recommenda ions Assessmen , De elopmen and E alua ion app oach.21 We do no en isage making clinical ecommenda ions om his la gely and exclusi ely epidemiological e idence base. The e may be no need o in e e e wi h p egnancy ho mones in o he wise heal hy emales. Howe e , i p ena al endogenous ho mones con ibu e o he isk o alle gy and as hma in he o sp ing, unde s anding his ole and he mechanisms h ough which hese ho mones ope a e is essen ial o he ield, as his will con ibu e o knowledge o he e al o igin o alle gy and as hma. Mo e- o e , since s udies ha e now epo ed such associa ions, wi h a ying esul s, a syn hesis o he unde lying e idence is essen ial in cla i ying any pu a i e ole o p ena al sex ho mones in he de elopmen o as hma and alle gy in he o sp ing. e hIcs and dIsseMIna Ion We comple ed he Ushe Ins i u e o Popula ion Heal h Sciences and In o ma ics Le el 1 e hics sel -assessmen o m, which indica ed ha no u he e hical pe mission was equi ed o his wo k as he s udy will only in ol e e iew o he published li e a u e. Ou indings will be epo ed in a pee - e iewed scien i ic jou nal. Au ho a ilia ions 1As hma UK Cen e o Applied Resea ch, Cen e o Medical In o ma ics, Ushe Ins i u e o Popula ion Heal h Sciences and In o ma ics, The Uni e si y o Edinbu gh, Edinbu gh, UK 2Depa men o Food and En i onmen al Sciences, Uni e si y o Helsinki, Helsinki, Finland 3Depa men o Pedia ics, Public Heal h Medicine, Uni e si y o Helsinki and Helsinki Uni e si y Hospi al, Uni e si y o Helsinki, Tampe e Uni e si y Hospi al, Helsinki, Finland 4School o Heal h Sciences, Uni e si y o Tampe e, Tampe e, Finland 5Depa men o Li es yle and Pa icipa ion, Nu i ion Uni , Na ional Ins i u e o Heal h and Wel a e, Helsinki, Finland 6Tampe e Cen e o Child Heal h Resea ch, Tampe e Uni e si y Hospi al, Tampe e, Finland g oup.bmj.com on Sep embe 5, 2017 - Published by h p://bmjopen.bmj.com/Downloaded om 4Talo icM, e al. BMJ Open 2017;7:e014637. doi:10.1136/bmjopen-2016-014637 Open Access 7Science Cen e o Pi kanmaa Hospi al Dis ic , Tampe e Uni e si y Hospi al and Uni e si y o Tampe e, Tampe e, Finland Con ibu o s BN concei ed he idea o his wo k and is he gua an o . AS con ibu ed subjec expe ise o he de elopmen o he p o ocol. The p o ocol was d a ed by MT and BN and was hen e ised a e se e al ounds o c i ical commen s om AS and addi ional eedback om MK, ME, SV and NM. All au ho s a e in ol ed in he sys ema ic e iew p ocess. Funding MT unde akes his wo k as pa o he equi emen o he disse a ion o he awa d o a Mas e ’s in Public Heal h a The Uni e si y o Edinbu gh. The wo k ecei ed no speci ic unding. BN was suppo ed by he Ins i u e o Ad anced Social Resea ch Fellowship, Uni e si y o Tampe e, Finland; School o Heal h Sciences, Uni e si y o Tampe e, Finland. Addi ional suppo was ecei ed om he Fa Ins i u e and As hma UK Cen e o Applied Resea ch. The iews p esen ed he e a e hose o he au ho s and no necessa ily hose o he Uni e si ies o Tampe e and Edinbu gh. Compe ing in e es s None decla ed. E hics app o al Le el 1 e hics o m om Edinbu gh Ins i u ional Re iew Boa d was comple ed o his s udy, which indica ed ha no e hics app o al is equi ed since i is based only on he published li e a u e. P o enance and pee e iew No commissioned; ex e nally pee e iewed. Open Access This is an Open Access a icle dis ibu ed in acco dance wi h he C ea i e Commons A ibu ion Non Comme cial (CC BY-NC 4.0) license, which pe mi s o he s o dis ibu e, emix, adap , build upon his wo k non-comme cially, and license hei de i a i e wo ks on di e en e ms, p o ided he o iginal wo k is p ope ly ci ed and he use is non-comme cial. See: h p:// c ea i ecommons. o g/ licenses/ by- nc/ 4. 0/ © A icle au ho (s) (o hei employe (s) unless o he wise s a ed in he ex o he a icle) 2017. All igh s ese ed. No comme cial use is pe mi ed unless o he wise exp essly g an ed. 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BMJ 2008;336:924–6. g oup.bmj.com on Sep embe 5, 2017 - Published by h p://bmjopen.bmj.com/Downloaded om a sys ema ic e iew and me a-analysis as hma and alle gy in o sp ing: p o ocol o ma e nal sex s e oid ho mones and isk o Pe iconcep ion endogenous and exogenous Minna Kaila, Su i M Vi anen and B igh I Nwa u Me hunisa Talo ic, Aziz Sheikh, Nicola McClea y, Maijaliisa E kkola, doi: 10.1136/bmjopen-2016-014637 2017 7: BMJ Open h p://bmjopen.bmj.com/con en /7/7/e014637 Upda ed in o ma ion and se ices can be ound a : These include: Re e ences #BIBLh p://bmjopen.bmj.com/con en /7/7/e014637 This a icle ci es 20 a icles, 3 o which you can access o ee a : Open Access h p://c ea i ecommons.o g/licenses/by-nc/4.0/non-comme cial. See: p o ided he o iginal wo k is p ope ly ci ed and he use is non-comme cially, and license hei de i a i e wo ks on di e en e ms, pe mi s o he s o dis ibu e, emix, adap , build upon his wo k Commons A ibu ion Non Comme cial (CC BY-NC 4.0) license, which This is an Open Access a icle dis ibu ed in acco dance wi h he C ea i e se ice Email ale ing box a he op igh co ne o he online a icle. Recei e ee email ale s when new a icles ci e his a icle. Sign up in he Collec ions Topic A icles on simila opics can be ound in he ollowing collec ions (349)Respi a o y medicine No es h p://g oup.bmj.com/g oup/ igh s-licensing/pe missions To eques pe missions go o: h p://jou nals.bmj.com/cgi/ ep in o m To o de ep in s go o: h p://g oup.bmj.com/subsc ibe/ To subsc ibe o BMJ go o: g oup.bmj.com on Sep embe 5, 2017 - Published by h p://bmjopen.bmj.com/Downloaded om