title: Publishing protocols for trials of complex interventions before trial completion - potential pitfalls, solutions and the need for public debate.
abstract: Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed.
  
  
  
  Triallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.
authors.affiliation: Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK. anna.basu@ncl.ac.uk.|Department of Paediatric Neurology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE7 7DN, UK. anna.basu@ncl.ac.uk.
authors.forename: Anna Purna
authors.initials: AP
authors.lastname: Basu
authors.affiliation: Therapy Services, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE7 7DN, UK.
authors.forename: Janice Elizabeth
authors.initials: JE
authors.lastname: Pearse
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Rapley
mesh_terms: D022126:Access to Information; D015982:Bias; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D033181:Information Dissemination; D010506:Periodicals as Topic; D011639:Public Opinion; D012107:Research Design; D016896:Treatment Outcome
keywords: Advance publication; Behaviour change; Clinical trials; Codesign; Complex interventions; E-Health; Open Science; Protocols; Therapy interventions; Trial registration