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Table 1 Gatekeepers and gatekeeper roles in diverse CRTs in health research

From: What is the role and authority of gatekeepers in cluster randomized trials in health research?

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]

  1. 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.
  2. bStudies that report ‘consent’ from a potential gatekeeper have not specified if this is cluster permission or proxy consent for cluster members.
  3. cIndex members were defined the ‘leaders of Roma (gypsy) men’s social networks’.
  4. 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’.
  5. 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.
  6. fResearchers reported that directors of nursing ‘were given the opportunity to participate in the study’ without further clarification.
  7. 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.