Examples

“The study was conducted in paediatric diabetes services experienced in the use of CSII [continuous subcutaneous insulin infusion], in nine University and six local hospitals within the NHS in England and Wales” [177].

 

“Setting: One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. Although described as a single centre, NHS Greater Glasgow and Clyde has the largest health board population (1.2m) in the United Kingdom. It is spread over a wide geographical area including severely materially deprived post-industrial areas as well as some more affluent communities. Maternity booking and antenatal care are provided in both hospital and local healthcare settings. Delivery (13 844 infants in 2013[reference]) takes place in three major maternity hospitals” [178].

 

Explanation

Along with the eligibility criteria for participants (item 12a) and the description of the interventions (item 13), information on the settings and locations where the trial was conducted is crucial to enable readers to judge the applicability and generalisability of a trial. Were participants recruited from primary, secondary, or tertiary healthcare, or from the community? Healthcare institutions vary greatly in their organisation, experience, and resources and the baseline risk for the condition under investigation. Other aspects of the setting, including the social, economic, and cultural environment, might also affect a study’s external validity.

 

Authors should report the number and type of settings and describe the care providers involved. They should report the locations in which the study was carried out, including the country, city if applicable, and immediate environment (eg, community, general practice, hospital outpatient clinic, or inpatient unit). In particular, it should be reported whether the trial was carried out in one site (single centre trials) or several sites (multicentre trials). The description of the setting should provide enough information so that readers can judge whether the results of the trial could be relevant to their own setting. The environment in which the trial is conducted might differ considerably from the setting in which the trial’s results are later used to guide practice and policy [179, 180]. Authors should also report any other information about the settings and locations that could have influenced the observed results.