Table 1 Prevalence of experience and reported impact of different factors on access to potential participants as reported by 98 CSOs
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) |