Example

 

“The trial is based in Kaffrine District, Senegal. The total population is 257 696 inhabitants. The population of children under 23 month is 17 780, and the prevalence of low birth weight (BW) is 17%. Data from 2015 indicated a prevalence of stunted children under five of 26.8%.[reference] The district has 28 health posts or clinics and 32 health huts administered by the Kaffrine Health Centre. The AASH [Action Against Stunting Hub] will recruit participants in seven clinics, and women participating in the AASH study will be targeted for the recruitment of their newborns in the SENGSYN study [202].

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“Study setting: Healthy pregnant individuals registered to deliver at either St. Paul’s Hospital or BC Women’s Hospital, Vancouver, British Columbia, Canada, and under the care of a regulated maternity care provider (midwife, obstetrician or family doctor) will be invited to participate in the study… Those registered but who ultimately deliver outside of either hospital will still be included in the study" [203]. 

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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].

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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