Explanation

Along with the eligibility criteria for participants (Item 14) and the description of the interventions/comparators (Item 15), information on the settings and locations where the trial will be conducted is crucial to assess the generalisability of the trial.(204) The environment in which the trial will be conducted may differ considerably from the setting in which the trial’s results are later used to guide practice and policy.

Reviews of two samples of 108 and 292 trial protocols from 2016 found that 42% and 56% listed the countries where data were to be collected; 40% and 44% reported the location of participant recruitment; and 90% and 91% described the setting of intervention delivery, respectively.(9, 10)

Authors of protocols should report the number and type of settings and describe the type of care providers involved. They should report the locations in which the trial will be carried out, including the country, city if applicable, and immediate environment (e.g., community primary care practice, hospital outpatient clinic, inpatient unit). In particular, it should be clear whether the trial will be carried out in one or more sites (i.e., single versus multicentre trial).

Summary of key elements to address

●      Setting of participant recruitment (e.g., primary or tertiary care; outpatient community or hospital clinic; inpatient unit)

●      Location(s) where the trial will be carried out (e.g., country, city)

●      Planned number of sites