title: Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials.
abstract: BACKGROUND
  Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts.
  
  
  METHODS
  The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies.
  
  
  CONCLUSIONS
  Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention.
  
  
  BACKGROUND
  The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.
authors.forename: Jo
authors.initials: J
authors.lastname: Rick
authors.forename: Jonathan
authors.initials: J
authors.lastname: Graffy
authors.forename: Peter
authors.initials: P
authors.lastname: Knapp
authors.forename: Nicola
authors.initials: N
authors.lastname: Small
authors.forename: David J
authors.initials: DJ
authors.lastname: Collier
authors.forename: Sandra
authors.initials: S
authors.lastname: Eldridge
authors.forename: Anne
authors.initials: A
authors.lastname: Kennedy
authors.forename: Chris
authors.initials: C
authors.lastname: Salisbury
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.forename: Paul
authors.initials: P
authors.lastname: Wallace
authors.forename: Vichithranie
authors.initials: V
authors.lastname: Madurasinghe
authors.forename: Adwoa
authors.initials: A
authors.lastname: Hughes-Morley
authors.affiliation: Medical Research Council North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK. peter.bower@manchester.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
mesh_terms: D022126:Access to Information; D003142:Communication; D003661:Decision Support Techniques; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D019212:Multimedia; D010353:Patient Education as Topic / Q000379:methods; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D016730:Program Development; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012108:Research Personnel; D035842:Research Subjects / Q000523:psychology; D018570:Risk Assessment; D018401:Sample Size