English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

Background  Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information.  We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates by conducting a pragmatic ‘study within a trial’ (SWAT) embedding a trial of a multimedia resource within an existing trial.    Methods  The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care.  For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource.  The multimedia resource was developed by patient and public involvement (PPI) contributors and researchers, and included  study-specific information  (e.g. study purpose, risks), and  generic information  about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components.  The primary outcome was the proportion of participants randomised.    Results  Nine point six percent of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (odds ratio (OR) = 0.844, 95% confidence interval (CI) 0.58 to 1.22).  We also found no effects on the proportion of people responding to the invitation (OR = 1.02, 95% CI 0.79 to 1.33) or retention in the trial at 6 (ORs 0.84, 95% CI 0.57 to 1.22) and 12 months after randomisation (ORs 0.80, 95% CI 0.54 to 1.18), respectively.    Conclusions  The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population.    Trial registration  Current controlled trials  ISRCTN 06710391 . Registered on 21 November 2013.    SWAT registration  SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START). Registered on 11 January 2012.    Electronic supplementary material  The online version of this article (10.1186/s13063-019-3496-z) contains supplementary material, which is available to authorized users.

trials

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled ‘study within a trial’ (SWAT) of a multimedia information resource