Background
Method
Materials
Survey instrument
A. Has participant experience of factor? | B. Participants assessment of the influence of factor on access to participants | ||||
---|---|---|---|---|---|
Valid responses = 98 (unless stated) | Enhances access | Makes no difference | Inhibits access | ||
N (%) | N (%) | N (%) | N (%) | ||
Site management position re. trial
| |||||
1 | Gatekeepers refer to the NHS commitment to patient participation in research |
41 (41.8)
|
68 (69.4)
|
28 (28.6)
|
2 (2.0)
|
2 | Gatekeepers have protected time to undertake research activity |
55 (56.1)
|
81 (82.7)
|
8 (8.2)
|
9 (9.2)
|
3 | Service management proactively endorse the trial and promote referral to the study |
77 (78.6)
|
93 (94.9)
|
4 (4.1)
|
1 (1.0)
|
4 | Managers instruct gatekeepers to refer potential participants |
76 (77.6)
|
83 (84.7)
|
9 (9.2)
|
6 (6.1)
|
5 | An identified member of the gatekeeping team is responsible for facilitating referral |
76 (77.6)
|
80 (81.6)
|
15 (15.3)
|
3 (3.1)
|
Trial design
| |||||
6 | Concurrent recruitment to multiple trials at research site |
89/97 (90.8)
|
11 (11.3)
|
24 (24.7)
|
62 (63.9)
|
7 | Trial design is non-simple |
78/97 (79.6)
|
0 (0)
|
26 (26.8)
|
71 (73.2)
|
8 | Gatekeepers are masked to treatment allocation |
88/97 (89.8)
|
5 (5.2)
|
68 (70.1)
|
24 (24.7)
|
Site characteristics
| |||||
9 | Site is undergoing substantial change such as reconfiguration or restructuring |
92 (93.9)
|
0 (0)
|
3 (3.1)
|
95 (96.9)
|
Relationship between recruitment and clinic procedures
| |||||
10 | Trial participation requires ongoing involvement of the gatekeeper (e.g. enabling attendance at an intervention/completing outcome measures) |
84 (85.7)
|
12 (12.2)
|
10 (10.2)
|
76 (77.6)
|
11 | Referral to the trial requires gatekeepers to complete questionnaires or an interview about themselves |
45 (45.9)
|
3 (3.1)
|
17 (17.3)
|
78 (79.6)
|
12 | Assessment of eligibility is integrated with routine clinical processes (e.g. case review) |
68 (69.4)
|
90 (91.8)
|
6 (6.1)
|
2 (2.0)
|
13 | Referral requires gatekeepers to complete questionnaires or an interview about trial participants |
80 (81.6)
|
6 (6.1)
|
12 (12.2)
|
80 (81.6)
|
Characteristics of the trial intervention
| |||||
14 | The trial intervention is only accessible through referral to the trial |
95 (96.9)
|
52 (53.1)
|
25 (25.5)
|
21 (21.4)
|
15 | Gatekeepers hold views about the effectiveness and/or appropriateness of the trial intervention (gatekeeper would not accept that equipoise exists) |
93/97 (94.9)
|
7 (7.2)
|
6 (6.2)
|
84 (86.6)
|
Trial marketing
| |||||
16 | Trial investigators have a structured approach to promoting the trial to gatekeepers |
81 (82.7)
|
76 (77.6)
|
17 (17.3)
|
5 (5.1)
|
17 | A senior member (e.g. principal investigator) of the research team meets with gatekeepers to promote the trial |
74 (75.5)
|
89 (90.8)
|
8 (8.2)
|
1 (1.0)
|
18 | Gatekeepers receive structured updates (e.g. regular newsletters/formal feedback at meetings) about recruitment progress |
90 (91.8)
|
82 (83.7)
|
15 (15.3)
|
1 (1.0)
|
19 | The trial is marketed directly to the target population (with a view to potential participants seeking referral) |
90 (91.8)
|
87 (88.8)
|
10 (10.2)
|
1 (1.0)
|
Service user involvement
| |||||
20 | Members of the target population (those potentially affected by trial outcomes) promote referral to the trial, with gatekeepers |
39/97 (39.8)
|
87 (89.7)
|
10 (10.3)
|
0 (0)
|
21 | Gatekeepers are advised that the target population has been involved in the trial design and/or implementation |
79 (80.6)
|
69 (70.4)
|
28 (28.6)
|
0 (0)
|
Clinician attitudes
| |||||
22 | Researchers share the professional background of the gatekeeper |
78 (79.6)
|
58 (59.2)
|
39 (39.8)
|
1 (1.0)
|
23 | Gatekeepers express a personal interest in research |
93 (94.9)
|
94 (95.9)
|
2 (2.0)
|
2 (2.0)
|
24 | Gatekeepers base referral on criteria other than those specified in the trial protocol (i.e. they make referrals on the basis of their opinion about suitability) |
85/94 (86.7)
|
11 (11.7)
|
12 (12.8)
|
72 (76.6)
|
25 | Gatekeepers believe trial participation will negatively affect their relationship with potential participants |
76 (77.6)
|
1 (1.0)
|
5 (5.1)
|
92 (93.9)
|
Incentives/motivational interventions
| |||||
26 | Incentives (e.g. chocolates/prize draw) are provided to gatekeepers for the referral of potential participants |
54 (55.1)
|
70 (71.4)
|
26 (26.5)
|
2 (2.0)
|
27 | Researchers encourage competition between study sites in relation to recruitment |
86 (87.8)
|
48 (49.0)
|
47 (48.0)
|
3 (3.1)
|
28 | Researchers are set specific recruitment targets which are monitored by their management |
96 (98.0)
|
54 (55.1)
|
40 (40.8)
|
4 (4.1)
|
29 | Site recruitment targets (number of participants and/or time frames) are agreed with gatekeepers |
75 (76.5)
|
57 (58.2)
|
37 (37.8)
|
4 (4.1)
|
Study sample and recruitment
Analysis
Results
Participants
Variable | Response | N (%) |
---|---|---|
Gender
| Male | 14 (14.3) |
Female | 80 (80.6) | |
Missing | 4 (4.1) | |
Age
| Years (Mean, SD) | 35.3 (9.4) |
Ethnicity
| White British/White Other | 81 (82.7) |
Asian/Asian British | 10 (10.2) | |
Black/Black British African | 1 (1.0) | |
Black/Black British Caribbean | 1 (1.0) | |
Other | 1 (1.0) | |
Missing | 4 (4.1) | |
Highest academic qualification
| Diploma | 5 (5.1) |
Bachelor’s degree | 42 (42.8) | |
Masters degree | 39 (39.8) | |
PhD | 4 (4.1) | |
Missing | 8 (8.2) | |
Professional qualifications
| Psychology | 31 (31.6) |
Nursing | 24 (24.5) | |
Allied health | 11 (11.2) | |
Physical sciences | 4 (4.1) | |
From which populations have you recruited to RCTs?
| Children (aged <13) | 33 (33.7) |
Adolescents (aged 13-18) | 50 (51.0) | |
Adults (aged 18-65) | 87 (88.8) | |
Older adults (aged >65) | 49 (50.0) | |
Severe mental illness | 75 (76.5) | |
Eating disorders | 25 (25.5) | |
Common mental health problems | 67 (68.4) | |
Drug & alcohol misuse problems | 54 (55.1) | |
Gambling problems | 4 (4.1) | |
From which settings have you recruited to RCTs?
| Primary care | 37 (37.8) |
Community mental health services | 87 (88.8) | |
Inpatient units | 59 (60.2) | |
Residential services | 33 (33.7) | |
Secure/forensic services | 22 (22.4) | |
Years of experience in research
| Mean (SD) | 4.3 (4.3) |
Years of experience recruiting to RCTs
| Mean (SD) | 3.4 (3.4) |
Number of RCTs recruited to
| Mean (SD) | 5.8 (4.7) |
Number of sites recruited from
| Mean (SD) | 9.1 (9.1) |
Very commonly reported (80% +) | Reported by majority (50-79%) | Reported by minority (<50%) | |
---|---|---|---|
Strong consensus (>80%) that factor enhances access to potential participants
|
23. Gatekeepers express interest in research |
17. A senior member of the research team meets gatekeepers to promote the trial. |
20. Members of the target population (those potentially affected by trial outcomes) promote referral to the trial with gatekeepers. |
18. Gatekeepers receive structured updates about recruitment progress |
4. Managers instruct gatekeepers to refer participants. | ||
19. The trial is marketed directly to the target population |
5. An identified member of the gatekeeping team is responsible for facilitating referral. | ||
3. Site management proactively endorses trial referral. | |||
12. Assessment of eligibility is integrated with routine clinical practice. | |||
2. Gatekeepers have protected time for research. | |||
Majority (50-79%) felt that factor enhances access to potential participants
|
14. The intervention is only accessible through the trial. |
29. Site recruitment targets (number of participants and/or time frames) are agreed with gatekeepers. |
1. Gatekeepers refer to the NHS commitment to patient participation in research. |
28. Researchers set recruitment targets. |
22. Researchers share the professional background of the gatekeeper. | ||
16. Trial investigators have a structured approach to promoting the trial. |
26. Incentives (e.g. chocolates/prize draw) are provided to gatekeepers for the referral of potential participants. | ||
21. Gatekeepers are advised that the target population has been involved in trial design | |||
Majority (>50%) reported factor made no difference
|
27. Researchers encourage competition between study sites in relation to recruitment | ||
8. Gatekeepers are masked to treatment allocation | |||
Majority (50-79%) felt that factor inhibits access to potential participants
|
6. Concurrent recruitment to multiple trials is taking place from individual sites. |
11. Referral to the trial requires gatekeepers to complete questionnaires or an interview about themselves. | |
24. Gatekeepers base referral on criteria other than those specified in the trial protocol. | |||
15. Gatekeepers hold views about the effectiveness/appropriateness of the intervention. |
7. Trial design is non-simple. | ||
Strong consensus (>80%) that factor inhibits access to potential participants
| |||
9. Site is undergoing substantial organisational restructuring/change. |
25. Gatekeepers believe trial participation will negatively affect their relationship with potential participants. | ||
10. Trial participation requires ongoing involvement of the gatekeeper. | |||
13. Referral requires gatekeepers to complete questionnaires or an interview about service users. |