Table 1.
Setting | Country | Cluster type | Level of intervention | Individual consent reported | Gatekeeper | Gatekeeper role | Ref. |
---|---|---|---|---|---|---|---|
Athletic organizations |
Norway |
Sports clubs |
Cluster |
No |
Coaches |
Agreement to participatea |
[12] |
Netherlands |
Geographic regions |
Individual |
No |
Coaches |
Consentb |
[13] |
|
Canada |
Athletic teams |
Individual |
Yes |
Head athletic therapist, trainer or sports medicine physician |
Identification of cluster members |
[14] |
|
Communities |
USA |
Cities |
Cluster |
No |
Community medical leaders |
Permission to randomize |
[15] |
USA |
Rural communities |
Cluster |
Yes |
Community advisory board |
Cluster consultation |
[16] |
|
Bulgaria |
Social circles |
Individual |
Yes |
Index memberc |
Identification of cluster members |
[17] |
|
Gambia |
Geographic areas/districts |
Individual |
Yes |
Community leaders |
Cluster permission |
[18] |
|
Tanzania |
Residential areas (Bazoli) |
Cluster |
Yes |
Tanzania Institute for Medical Research |
Protocol approval |
[19] |
|
India |
Villages |
Individual |
Yes |
Local health system and community leaders |
Cluster consultation; agreement to participatea |
[20] |
|
Uganda |
Villages |
Individual |
Yes |
Local government authorities and local leaders |
Protocol approval |
[21] |
|
Health centers |
USA |
Health centers |
Individual |
Yes |
Practicing internists |
Identification of cluster members; permission to approach cluster members |
[22] |
UK |
Primary-care practices |
Cluster/ Individual |
Yes |
Primary-care trust administrative authority |
Protocol approval |
[23] |
|
UK |
Primary-care practice locations |
Cluster |
Yes |
General practitioners |
Identification of cluster members; permission to approach cluster members |
[24] |
|
UK |
Midwives |
Individual |
Yes |
NHS trustsd |
Agreement to participatea |
[25] |
|
Nursing homes |
Canada |
Nursing homes |
Individual |
Yes |
Management |
Not applicablee |
[26] |
Australia |
Nursing homes |
Individual |
Yes |
Director of nursing |
Not applicablef |
[27] |
|
UK |
Nursing homes |
Individual |
Yes |
Management |
Agreement to participatea |
[28] |
|
New Zealand |
Wards within nursing homes |
Individual |
Yes |
Senior management |
Consentb |
[29] |
|
Schools |
Germany |
Classrooms |
Cluster |
Yes |
Responsible local governments |
Agreement to participatea |
[30] |
Belgium |
Classrooms |
Cluster |
No |
Principals |
Organizational permission |
[31] |
|
USA |
Classrooms |
Cluster |
No |
School districtg |
Protocol approval |
[32] |
|
UK |
Teachers |
Individual |
Yes |
Principals |
Organizational permission |
[33] |
|
Canada |
Schools |
Cluster |
No |
District principals |
Proxy consent for cluster members |
[34] |
|
Work sites |
Sweden |
Work sites |
Individual |
No |
Managers and human resources |
Identification of cluster members; permission to randomize |
[35] |
USA |
Work sites |
Cluster |
No |
Employee advisory board |
Cluster consultation |
[36] |
|
USA |
Fire stations |
Individual |
Yes |
Department chiefs/ union representatives |
Identification of cluster members; organizational permission |
[37] |
|
USA | Pools | Individual | Yes | Pool managers, community advisors, recreation leaders, pool directors | Cluster consultation | [38] |
aSeveral studies report ‘agreement to participate’ or ‘permission to conduct the study’ although it remains unclear if these are cluster permission, protocol approval, or another gatekeeper role.
bStudies that report ‘consent’ from a potential gatekeeper have not specified if this is cluster permission or proxy consent for cluster members.
cIndex members were defined the ‘leaders of Roma (gypsy) men’s social networks’.
dMidwives may also have acted as gatekeepers as ‘all participating midwives were given detailed training on the procedure to identify, recruit, and obtain written informed consent from participants’.
eGatekeeper involvement was indicated by the statement that ‘[n]ursing homes withdrew…based on a decision by the nursing home management’, although a specific role was not given.
fResearchers reported that directors of nursing ‘were given the opportunity to participate in the study’ without further clarification.
gThis study also used a joint staff service committee (principal, vice principal, and faculty) that was informed and provided support for the study. The committee was not identified as a gatekeeper.