biostudies-literaturePogorzelski DNCATS NIH HHSPhysicians&apos; Services Incorporated FoundationU.S. Department of DefensePatient-Centered Outcomes Research Institute100730https://www.ebi.ac.uk/biostudies/studies/S-EPMC7873628biostudies-literatureUnknown21<h4>Introduction</h4>Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.<h4>Methods</h4>Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategyContemporary clinical trials communicationsManaging work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.PMC7873628UL1 TR003167Bailey DO'Hara NNMalekzadeh ASPilson HOperating Room CoreWilliams DRuth JTDel Fabbro GSzasz OPMarmor MWilliams ARudnicki JRamsey TBLittle KTaylor MGirardi CSeymour RRajaratnam KGardner MJLanghammer CGrissom MFSchaller TMPellejero-Garcia REsposito JGPatient Centred Outcomes CoreHaller JMKettering EReilly RMSlobogean GPBlasman JGraells-Alonso GNeese AHowe AHebden JHurkett CBrownrigg MRojas AData and Safety Monitoring CommitteeRussell MJeray KJMorshed SRistevski BLhowe DWMiclau TKimmel JPichiotino ERWilliams WSparrow CWadenpfuhl LKZura RBergin PFPotter DCruz AGeorge AD'Alleyrand JCPham KHHaaser SMGraves MLPrayson MHarris MBFan CBSmith RMSims SDevereaux PJMarchand LWarner SJNascone JBoyce RCross AWMiller AGage MJSadasivan KHorne BJohnson LNMcMaster University Methods CenterVallier HAVelasco-Barrera ADonegan DJohal HPierrie SMartinez-Grau PEnglish ADAqueous-PREP and PREPAREWentworth DSridhar MSMatityahu AMarti-Garin DSteering CommitteeHagen JERamsey LMunz JWSmith CDManson TKrupko THsu JGjorgjievski MWilson ESTownsend CEBansal MReilly CAGuyatt GHEglseder AStinner DJHollinsworth TFraifogl JHiggins TFDooley MAltman KMSoler-Cano AMcClellan RTFowler JHalliday PGVan CMoola FOTanner SLWells JGaritty MJParker WPaul ACamara MMehta SMaltz EJRao MChip Routt MLThabane LSaeed SGarcia YParyavi ESanders JLCoe MBedard JCMeinberg EBoyer DSSanz-Molero MPenalver JMAlavedra-Massana ALi SCulbert HSnider RGAhn JPollak ALeonard JDemyanovich HMedeiros Mvon Keudell AGFuentes-Lopez RMartinez EKnapp TLebrun CGajari VGaski GEMullin DSHudgins AMilitary CoreHofer EAPhelps KTalerico MVirkus WWGuerra EMayberry RMCole AABreslin MARussell GVCarlisle RMScott TGallant JMillon SJDePalo PJohnson AVenkatarayappa IMorellato JHeng MBeer RLoeffler MFKandemir UGary JLCamara-Cabrera JMarcano-Fernandez FABullard DPorter SEYela-Verdu CBaele JRMartin AHymes RAFriedrich JCuff JARomeo NMPREP-IT Investigators Executive CommitteeRobertson EMossuto FGoodman JBPayne KLiang SPensy RGurich RWClark LJerele JCarballo APatrick MKoenig COrthopaedic Surgery CoreGarcia-Rodriguez RDykes TChoo AMBartel CBoulton CApostle KLSanchez-Fernandez JAdjudication CommitteeMarshall WADehghan NTalbot MO'Toole RVSprague SToogood PCaparros-Garcia ADegani YBhanat ELUniversity of Maryland School of Pharmacy, The PATIENTS ProgramSanchez-Palomino EHall AEBueno-Ruiz MHoran AMarcano-Fernandez FResearch Methodology CoreMarvel DTrochez KAnglada-Torres NPREPAREDavies JJoshi MGAl-Asiri JJornet-Gibert MPelfort XMcKay PBerenguer AInfectious Disease CoreDew TPalmer MJHuggins BSPetrisor BAOsborn PHalvorson JJKuczinski AChampion HKDemyanovich HKMullis BHFillat-Goma FSchwartzbach CCBhandari MWeaver MJPritchett CJaeblon TColello MRay SBZomar MLowney MKarunakar MViskontas DGStewart RWood AJones CBMitchell PCarroll EAPREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE)Rivera JBurnikel APechero GKarim ASeach ASerrano-Sanz JIwu ABrown TRJahangir AAObremskey WTWalker CMRafols-Perramon ODomenech MSSietsema DLMartinez-Carreres LHeels-Ansdell DAcerboni-Flores FMcGee SLMoody MCHolden MBHill LCFaucher GKHale DSorkin ATWatson JTDella Rocca GJWise JChurchill CLowe JSethi MBeckish MLSims MLShearer DBray CCVlasak RMcTague MFMayfield AMcKinley TOGarg KDwyer KPoole ASRothberg DLPogorzelski DGimeno-Calavia NDing ABerhaneselase EO'Hara LMAllen EMDas SGitajn ILRodriguez EUniversity of Maryland School of Medicine Administrative CenterSciadini MAchor TSRodriguez AStone TBMullins DCAhn JSPersico FLemke HMPerey BHDodds SAqueous-PREPHolzman MAHunter MDMcKee MKempton LAdams JDSpicer EVanDemark RMcGee SBelaye TNguyen UTaljaard MDonohue ESzatkowski JPSchwartz JBosse MPfaff BJoseph KPanjshiri FPREP-IT Investigators Executive Committee:Mullins CDLazarus DEDenkers MBabcock SNatoli RMWild JMartinez-Alvarez MHarris ADPalmer JGaribaldi ASchulman JERudisill LEfalseManaging work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.<h4>Introduction</h4>Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.<h4>Methods</h4>Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy2021-01-01T00:00:00Z2021 Mar2025-06-01T12:19:16.579Z2021-02-23T08:12:54ZS-EPMC78736283360594610.1016/j.conctc.2021.100730