Biostatistician behind bars: by design and on trial

Sheila Bird (University of Cambridge, UK)

A quarter century of surveillance designs (with associated biological sample), record-linkage studies, and bespoke "questionnaries" - a phrase coined from Hill and Doll - have improved prisoners' access to harm reduction (eg Hepatitis B immunization), contributed to changed policy in prisons (eg put an end to random mandatory drugs testing), got us barred, yet quantified a 7 times higher risk of overdose death soon after prison-release, and eventually enabled three musketeers to mount the pilot N-ALIVE Trial in England to test whether those randomized to receive naloxone-on-release have 30% fewer opioid-related deaths in the 4-weeks post-release than controls (prior estimate: 1 in 200).

Even before the N-ALIVE Trial's first randomization, however, Scotland became the first country to introduce take-home-naloxone as a funded public health policy. Wales followed in May 2011. I shall describe the trials and tribulations of Scotland's closely-monitored evaluation of its 2011-15 National Naloxone Programme, which is complicated because Scotland's policy was introduced against a still-rising trajectory of age-related opioid-deaths.

Is it impact for an RCT to be overtaken by the policy it seeks to inform?