Read on Twitter
1/ THREAD: Here are some of the things I admire about Bridge-It, a pragmatic cluster-randomised crossover trial from colleagues at @hsru_aberdeen published in @TheLancet https://twitter.com/hsru_aberdeen/status/1327175492710117379
2/ First thing I noticed was a justification for the choice to use cluster over individual randomisation:
"We chose cluster design because the pilot study showed that randomisation of individual participants (rather than pharmacies), would not recruit enough participants."
"We chose cluster design because the pilot study showed that randomisation of individual participants (rather than pharmacies), would not recruit enough participants."
3/ Since people often fail to report a justification, I was EVEN MORE EXCITED to see a justification for the use of the crossover design:
"The crossover design was chosen for efficiency so that each cluster was acting as its own control and fewer pharmacies were required."
"The crossover design was chosen for efficiency so that each cluster was acting as its own control and fewer pharmacies were required."
4/ Although the clusters are the unit of randomisation, the study interventions are divisible to the level of the individual. This means that there is a presumption for investigators to obtain informed consent from trial participants.
5/ And so: "Pharmacists assessed women’s eligibility for the study, invited them to participate, and obtained written informed consent for the study (including access to sexual and reproductive health records and data linkage with the national abortion registries)." Nice!
6/ As an added bonus: "Pharmacists also provided a patient information sheet." (I assume the information was about the trial, but it would be great to know what was included in this.)
7/ Question: To what degree does training health providers about research prior to its conduct interfere with the aims of pragmatism? @charlesweijer @SpencerPHey @AlexJohnLondon @GrimshawJeremy @scottbioethics @MzwarEn @shauntreweek @MarionKCampbell
8/ A challenge for this trial: "pharmacists are typically unfamiliar with participating in research" & "asking [them] to recruit participants, provide further information, and complete additional paperwork" added burden & resulted in large recruitment differences between sites.
9/ Ideally, pragmatic trials require no (or little) additional resources and mimic the real-world setting as closely as possible. But the provision of training to health providers may reduce research burdens and improve recruitment. Is this a common consideration?
