biostudies-literatureNIHR Global Research Health Unit on Global SurgeryNational Institute for Health Research (NIHR)259https://www.ebi.ac.uk/biostudies/studies/S-EPMC10077601biostudies-literatureUnknown24(1)<h4>Background</h4>Cluster randomised controlled trials (cRCT) present challenges regarding risks of bias and chance imbalances by arm. This paper reports strategies to minimise and monitor biases and imbalances in the ChEETAh cRCT.<h4>Methods</h4>ChEETAh was an international cRCT (hospitals as clusters) evaluating whether changing sterile gloves and instruments prior to abdominal wound closure reduces surgical site infection at 30 days postoperative. ChEETAh planned to recruit 12,800 consecutive patients from 64 hospitals in seven low-middle income countries. Eight strategies to minimise and monitor bias were pre-specified: (1) minimum of 4 hospitals per country; (2) pre-randomisation identification of units of exposure (operating theatres, lists, teams or sessions) within clusters; (3) mTrialsStrategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries.PMC1007760116/136/79Zuloaga Fernandez Del Valle CJBatangana MGautham AKOriji VKWani RASamuel VMChowdri NAMumuni KHaque PDKanyarukiko SPeters NJAdze JAIbarra Camargo SABarimah CGAdeoluwa ASowande OASeyi-Olajide JOGundu ISivakumar MVVillela GMEde CJChaturvedi AMiranda Ackerman RCMshelbwala PMAwodele KSukumar AHadonou ARwagahirima EOsagie OOOsagie OTNaah ANtwari GKalyanapu JAMathew AEOgudi DKDMathai SBarradas PDMathew AJMuroruhirwe PQuarchey KNDBature SBPai MVMukamazera LSethoana MEAlly ZAlpheus RAFasanu AOAppiah ABTijerina Avila JJOgunyemi AAOyelowo NPerez Bocanegra VHTabiri 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FAkoto ESingh SRamirez DOKoledade AKAkpla MDaluk EBEniola SBTabuanu NOBaolboa LGPMutabazi EBalogun AOMorales JFMMgbemena CVNunoo-Ghartey KWondoh PChoudhrie AVAdeniyi AAMalechi HOwie EMalade EShah ZAAtoyebi OANsilu JNTinajero CCSalawu AIPrakash PUsman MImam ZOYome HDuru NJNiyongombwa IMaalekuu AVillanueva-Martinez EEKyeremeh CEmeka JJNyirasebura DKumari POkonoboh TOVicencio Ramirez MLAlhassan JDominguez ACGTeye-Topey CUgboajah JODuruewuru IOArias RGCGoudou RMusengo FBHounsou NROlajide TOThami GTrinity POrewole TOAlasi IOKudoh VMohammed-Durosinlorun AASakyi ACalderon Llamas MAOwusu FMoreno-Portillo MGarcia Gonzalez LAHospital Principle InvestigatorYevide ABWilliams RGuevara GCOkoro PERomo Ascencio EVOjewuyi ARAdebayo SAAgboadoh NAriyibi ALHedefoun SEEgharevba PATakai IUKichu MAvalos Herrera VJAdeyeye AAOlanrewaju OAnasara GAGMathew SGeorge MDHamadou SBakare AAmponsah-Manu FVishnoi JRZepeda FDAlia BAWordui TGuerrero Ramirez CSTobome SRKola HPAgyemang EVarghese RSanchez Martinez JAAgbadebo MUsam EAgossou HHoundji AChaudhary RChristian NAOwusu PYAgbowada EAAbiyere HOKpangon CMagashi MKMbajiekwe NPoonia DRDusabeyezu MOyegbola CBSentholang NSaluja SSKanyesigye SGuzman Barba JABruce-Adjei AAbdus-Salam RAIhediwa GCUzikwambara LOshodi YANirere FAbraham ESLomeli AFMAsabre ESreekar DYusuf SAAnyanwu NAggarwal MCifuentes Andrade LREtchisse LRodriguez IOOmotola OEzenwa AORobertson ZAgbulu MVOnu OAFatuga ALRajan SVillasenor GSArroyo GLAbdur-Rahman LOHabumuremyi SEscobar CNSuarez Carreon LOVega Gastelum JOBawa KGMoore ROludara MAPathak MLuri PTAwere-Kyere LKBZechariah PPais RMHernandez ABTorres MIAgyen TAlvarez Villasenor ASAhogni DIsmavel VALokavarapu MJYhoshu EAngeles LOMChejfec Ciociano JMBarreiro AOAmoako-Boateng MPBecerra Moscoso MRMorkor Opandoh INGonzalez Ponce FYAwoyinka BSKoomson BBoukari KAMalik MASeenivasagam RKMartinez ECOrozco CFAttepor GSDewamon HMandrelle KDar RAUche CFSambo AAdu-Aryee NAGuzman Ruvalcaba MJTolani MADhar TRuiz Velasco CBFatudimu OSTotin MKoggoh PGandaho IBanka CAlhassan MSHernandez EELRamirez JARInyang ESYigah MMukangabo Cde Dieu Haragirimana JDukuzimana RNgaguene JOjo ODIgiraneza JAscencio Diaz KVSallau SBHoundote ABakari FAttinon JMichael VPrasad SRamirez Gonzalez LRDokurugu MABadmus TAGhosh DNLarbi-Siaw LADelano-Alonso ROjewuyi OOIbarrola Pena JCTimo MTTrejo-Avila MAbdul-Aziz IIAGbenga-Oke CDusabimana ABucyibaruta GOkoye OAHinvo SMisra SMathe MNMuhammad ABOlayioye OMutimamwiza IUwayezu RAbdulkarim AAKarekezi AMellado DHOladele OOAlitonou AKache SAKouroumta MCUgwu AOOshodi OASehrawat VIji LOBabalola OFSoibi-Harry APBallu CAmbriz-Gonzalez GFaboya OMMohammed TOYussif SButana HTakure AONoufuentes CBrancaccio Perez IVHinojosa RNMukasine AAjibola GKabanda EfalseStrategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries.<h4>Background</h4>Cluster randomised controlled trials (cRCT) present challenges regarding risks of bias and chance imbalances by arm. This paper reports strategies to minimise and monitor biases and imbalances in the ChEETAh cRCT.<h4>Methods</h4>ChEETAh was an international cRCT (hospitals as clusters) evaluating whether changing sterile gloves and instruments prior to abdominal wound closure reduces surgical site infection at 30 days postoperative. ChEETAh planned to recruit 12,800 consecutive patients from 64 hospitals in seven low-middle income countries. Eight strategies to minimise and monitor bias were pre-specified: (1) minimum of 4 hospitals per country; (2) pre-randomisation identification of units of exposure (operating theatres, lists, teams or sessions) within clusters; (3) m2023-01-01T00:00:00Z2023 Apr2026-03-17T15:19:32.057Z2025-04-06T00:31:56.377ZS-EPMC100776013702031110.1186/s13063-022-06852-2