A weighted-random sample of 12 500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified.
Around 1.2m incidents are being voluntarily reported each year in the NHS, the vast majority of which cause no or low harm – but they provide a huge learning opportunity which will grow as more reports are made.
In prospective studies of children and young adults, low harm avoidance has been associated with worse health-related behavior and health outcomes, possibly because young people with a low level of harm avoidance trait tend to engage in risky behaviors [ 4, 5].
Harm was defined by user self-reports; the degree of harm was classified as either: no harm, low harm (minimal harm patient(s) required extra observation or minor treatment), moderate harm (short-term harm patient(s) required further treatment, or procedure), severe harm (permanent or long-term harm) or death.
David Nutt, who was sacked in 2009 by the then home secretary after claiming ecstasy and LSD were less dangerous than alcohol, said: "Its evidenced, measured recommendation to use current legislation and community measures to address the relatively low harms of khat is just the sort of rational thinking that we need more of in the drug policy debate".
Its size, duration and the inclusion of reports of low levels of harm as well as adverse outcomes, are all unique strengths.
This pragmatic randomised controlled trial will fill an important gap in our understanding of the potential harms and benefits of a low intensity harm reduction intervention: brief advice encouraging long-term use of existing forms of medicinal nicotine (mouth spray, inhalator, gum, lozenge) and e-cigarettes as cigarette substitutes, in addition to advice on short-term use to quit smoking.
This is one of many examples of the perverse effects of prohibition: limiting availability of a relatively low-harm drug can lead to greater harms from alternatives.
The analysis of the algorithms brings to the fore that the CHUK algorithm is the one that leads to the highest sensitivity and induces the lowest harm in terms of morbidity and mortality.
Such research is of low risk of direct harm to the original subjects/patients, but may harm them indirectly or run against their reasonable will if the relevant sensitive information is leaked or misused by the researchers.
