From: A survey of facilitators and barriers to recruitment to the MAGNETIC trial
Factor | Facilitator, n (%) | Not applicable, n (%) | Barrier, n (%) | ||||||
---|---|---|---|---|---|---|---|---|---|
O | PI | RN | O | PI | RN | O | PI | RN | |
Funding | 55 (33.0) | 14 (43.8) | 13 (43.3) | 88 (52.7) | 13 (40.6) | 9 (30.0) | 24 (14.4) | 5 (15.6) | 8 (26.7) |
Trial design | 71 (42.5) | 12 (37.5) | 13 (43.3) | 33 (19.8) | 5 (15.6) | 5 (16.7) | 63 (37.8) | 15 (46.9) | 12 (40.0) |
Patient inclusion criteria | 96 (57.5) | 20 (64.5) | 20 (66.7) | 25 (15.0) | 4 (12.9) | 3 (10.0) | 46 (27.6) | 7 (22.6) | 7 (23.3) |
MAGNETIC being a drug trial | 50 (30.0) | 10 (31.3) | 6 (20.7) | 49 (29.3) | 17 (53.1) | 5 (17.2) | 68 (40.7) | 5 (15.6) | 18 (62.1) |
Study protocol compared to clinical practice | 61 (36.6) | 13 (40.6) | 12 (40.0) | 28 (16.8) | 9 (28.1) | 1 (3.3) | 78 (46.7) | 10 (31.3) | 17 (56.7) |
Clinical equipoise | 69 (42.8) | 13 (41.9) | 16 (53.3) | 72 (44.7) | 16 (51.6) | 10 (33.3) | 20 (12.4) | 2 (6.5) | 4 (13.3) |
Previous feasibility assessment | 51 (31.3) | 9 (28.1) | 11 (39.3) | 99 (60.7) | 20 (62.5) | 15 (53.6) | 13 (8.0) | 3 (9.4) | 2 (7.1) |
Previous pilot trial | 52 (32.1) | 10 (32.3) | 11 (39.3) | 104 (64.2) | 19 (61.3) | 16 (57.1) | 6 (3.7) | 2 (6.5) | 1 (3.6) |
Publicity by the trial team | 103 (62.9) | 19 (59.4) | 22 (75.9) | 43 (26.2) | 12 (37.5) | 1 (3.4) | 18 (10.9) | 1 (3.1) | 6 (20.7) |
External publicity | 36 (21.8) | 6 (18.8) | 6 (20.7) | 110 (66.7) | 24 (75.0) | 17 (58.6) | 19 (11.6) | 2 (6.3) | 6 (20.7) |
Trial management | 101 (62.0) | 19 (59.4) | 24 (82.8) | 42 (25.8) | 9 (28.1) | 2 (6.9) | 20 (12.3) | 4 (12.5) | 3 (10.3) |
Protocol amendments | 49 (29.5) | 5 (15.6) | 12 (40.0) | 90 (54.2) | 20 (62.5) | 14 (46.7) | 27 (16.3) | 7 (21.9) | 4 (13.3) |
Seasonal variation | 40 (24.0) | 4 (12.5) | 10 (33.3) | 40 (24.1) | 8 (25.0) | 2 (6.7) | 86 (51.8) | 20 (62.5) | 18 (60.0) |
Site-level factors | |||||||||
Time to open up site | 33 (20.0) | 5 (15.6) | 6 (20.0) | 75 (45.5) | 9 (28.1) | 11 (36.7) | 57 (34.5) | 18 (56.3) | 13 (43.3) |
Recruitment target | 62 (37.8) | 11 (34.4) | 13 (46.4) | 59 (36.0) | 12 (37.5) | 9 (32.1) | 43 (26.2) | 9 (28.1) | 6 (21.4) |
Time to complete administrative work related to the trial | 24 (14.3) | 3 (9.4) | 7 (23.3) | 32 (19.0) | 9 (28.1) | 5 (16.7) | 112 (66.6) | 20 (62.5) | 18 (60.0) |
Number of trained staff | 26 (15.5) | 4 (12.5) | 3 (10.0) | 12 (7.1) | 2 (6.3) | 2 (6.7) | 130 (77.3) | 26 (81.3) | 25 (83.3) |
Local clinical arrangements | 43 (26.1) | 7 (22.6) | 6 (20.0) | 36 (21.8) | 7 (22.6) | 3 (10.0) | 86 (52.1) | 17 (54.8) | 21 (70.0) |
Choice of recruitment setting | 72 (43.9) | 12 (37.5) | 13 (43.3) | 39 (23.8) | 9 (28.1) | 2 (6.7) | 53 (32.3) | 11 (34.4) | 15 (50.0) |
Good Clinical Practice (GCP) training | 33 (19.8) | 2 (6.3) | 4 (13.3) | 18 (10.8) | 3 (9.4) | 0 (0) | 116 (69.6) | 27 (84.4) | 26 (86.7) |
Data collection process | 44 (26.5) | 10 (31.3) | 6 (20.0) | 44 (26.5) | 14 (43.8) | 4 (13.3) | 78 (47.0) | 8 (25.0) | 20 (66.7) |
Competing local research projects | 23 (13.8) | 2 (6.3) | 3 (10.0) | 116 (69.5) | 25 (78.1) | 19 (63.3) | 28 (16.8) | 5 (15.6) | 8 (26.7) |
Local research culture | 65 (39.2) | 13 (40.6) | 7 (23.2) | 32 (19.3) | 7 (21.9) | 1 (3.3) | 69 (41.6) | 12 (37.5) | 22 (73.3) |
Patient factors | |||||||||
Consent rate | 48 (29.1) | 6 (18.8) | 8 (26.7) | 39 (23.6) | 11 (34.4) | 5 (16.7) | 78 (47.2) | 15 (46.9) | 17 (56.7) |
Familiarity with experimental treatment | 52 (31.3) | 7 (21.9) | 7 (23.3) | 44 (26.5) | 13 (40.6) | 5 (16.7) | 70 (42.1) | 12 (37.5) | 18 (60.0) |
Parent's attitude towards their child taking experimental medicine or placebo | 26 (15.6) | 3 (9.4) | 5 (17.2) | 45 (27.1) | 15 (46.9) | 6 (20.7) | 95 (57.2) | 14 (43.8) | 18 (62.1) |
Parent's preference for a particular treatment | 16 (9.6) | 0 (0.0) | 3 (10.0) | 92 (55.4) | 26 (81.3) | 14 (46.7) | 58 (34.9) | 6 (18.8) | 13 (43.3) |
Parent's concerns about side effects of new drug | 12 (7.2) | 1 (3.1) | 1 (3.3) | 46 (27.5) | 16 (50.0) | 6 (20.0) | 109 (65.3) | 15 (46.9) | 23 (76.7) |
Duration of trial and follow-up | 59 (35.5) | 11 (34.4) | 12 (41.4) | 62 (37.3) | 17 (53.1) | 7 (24.1) | 45 (27.1) | 4 (12.5) | 10 (34.5) |
Treatment choice by random allocation | 42 (25.2) | 7 (21.9) | 7 (23.3) | 80 (47.9) | 21 (65.6) | 13 (43.3) | 45 (27.1) | 4 (12.5) | 10 (33.3) |
Additional trial investigations | 15 (9.1) | 3 (9.4) | 2 (6.7) | 111 (67.3) | 26 (81.3) | 17 (56.7) | 39 (23.6) | 3 (9.4) | 11 (36.7) |
Additional travel and extra costs | 9 (5.4) | 3 (9.4) | 2 (6.7) | 146 (88) | 27 (84.4) | 27 (90.0) | 11 (6.6) | 2 (6.3) | 1 (3.3) |
Intervention available only in the trial | 34 (20.5) | 5 (15.6) | 10 (33.3) | 108 (65.1) | 25 (78.1) | 16 (53.3) | 24 (14.4) | 2(6.3) | 4 (13.3) |
Communication between research team and parents | 83 (50.1) | 11 (34.4) | 21 (70.0) | 55 (33.1) | 19 (59.4) | 3 (10.0) | 28 (16.8) | 2(6.3) | 6 (20.0) |
Clinician influence | 73 (44.0) | 9 (28.1) | 14 (46.7) | 67 (40.4) | 19 (59.4) | 8 (26.7) | 26 (15.6) | 4 (12.5) | 8 (26.7) |
Language or cultural barriers | 11 (6.1) | 1 (3.1) | 1 (3.3) | 72 (43.1) | 20 (62.5) | 13 (43.3) | 84 (50.3) | 11 (34.4) | 16 (53.3) |
Clinical team factors | |||||||||
Research experience of clinical team | 71 (42.6) | 17 (53.1) | 6 (20.0) | 16 (9.6) | 3 (9.4) | 1 (3.3) | 80 (47.9) | 12 (37.5) | 23 (76.7) |
Presence of designated research nurse/practitioner | 113 (68.1) | 22 (68.8) | 19 (65.5) | 17 (10.2) | 2 (6.3) | 2 (6.9) | 36 (21.6) | 8 (25.0) | 8 (27.6) |
Availability of designated research team | 97 (58.5) | 21 (65.6) | 18 (60.0) | 24 (14.5) | 5 (15.6) | 0 (0) | 45 (27.0) | 6 (18.8) | 12 (40.0) |
Availability of research staff out of hours | 30 (18) | 5 (15.6) | 6 (20.0) | 42 (25.1) | 8 (25.0) | 5 (16.7) | 95 (57.0) | 19 (59.4) | 19 (63.3) |
Shift patterns of work | 15 (9) | 3 (9.4) | 1 (3.3) | 22 (13.3) | 2 (6.3) | 4 (13.3) | 129 (77.7) | 27 (84.4) | 25 (83.3) |
Motivation of clinical team | 89 (53.6) | 16 (50.0) | 12 (40.0) | 14 (8.4) | 4 (12.5) | 1 (3.3) | 63 (37.9) | 12 (37.5) | 17 (56.7) |
Clinical workload | 11 (6.6) | 2 (6.3) | 1 (3.3) | 10 (6.0) | 2 (6.3) | 1 (3.3) | 146 (87.3) | 28 (87.5) | 28 (93.3) |
Perceived importance of research generally in clinical practice | 76 (45.8) | 14 (43.8) | 8 (26.7) | 24 (14.5) | 3 (9.4) | 3 (10.0) | 66 (39.8) | 15 (46.9) | 19 (63.3) |
Perceived importance of the particular research question | 99 (60.1) | 20 (62.5) | 16 (53.3) | 34 (20.6) | 6 (18.8) | 6 (20.0) | 32 (19.4) | 6 (18.8) | 8 (26.7) |
Communication skills of clinical team | 116 (70.3) | 24 (75) | 19 (63.3) | 26 (15.8) | 7 (21.9) | 2 (6.7) | 23 (13.9) | 1 (3.1) | 9 (30.0) |
Clinician preference for particular treatment | 36 (22.0) | 5 (16.1) | 7 (24.1) | 110 (67.5) | 23 (74.2) | 19 (65.5) | 17 (10.4) | 3 (9.7) | 3 10.3) |
Clinician attitude to involving patients in research | 101 (60.9) | 18 (56.3) | 18 (60.0) | 35 (21.1) | 9 (28.1) | 5 (16.7) | 30 (18.0) | 5 (15.6) | 7 (23.3) |
Difficulty in approaching patients for consent | 16 (9.6) | 3 (9.4) | 4 (13.3) | 61 (36.5) | 16 (50.0) | 11 (36.7) | 90 (53.9) | 13 (40.6) | 15 (50.0) |
Information and consent-related factors | |||||||||
Amount and complexity of trial information provided | 53 (31.9) | 10 (31.3) | 11 (36.7) | 30 (18.1) | 11 (34.4) | 2 (6.7) | 83 (50.0) | 11 (34.4) | 17 (56.7) |
Clarity in presentation of trial information | 97 (58.4) | 19 (59.4) | 20 (66.7) | 25 (15.1) | 8 (25.0) | 2 (6.7) | 44 (26.5) | 5 (15.6) | 8 (26.7) |
Social and emotional dynamics of trial discussion | 35 (21.0) | 7 (21.9) | 10 (33.3) | 78 (47.0) | 20 (62.5) | 8 (26.7) | 53 (31.9) | 5 (15.6) | 12 (40.0) |
Time and setting of consent seeking | 18 (10.8) | 2 (6.3) | 4 (13.3) | 22 (13.2) | 4 (12.5) | 3 (10.0) | 127 (76.0) | 26 (81.3) | 23 (76.7) |
Senior doctors and nurses seeking consent | 75 (45.3) | 8 (25.8) | 16 (53.3) | 25 (15.1) | 5 (16.1) | 2 (6.7) | 66 (39.8) | 18 (58.1) | 12 (40.0) |
Experience and training of clinical team seeking consent | 84 (50.4) | 12 (37.5) | 16 (53.3) | 27 (16.2) | 8 (25.0) | 0 (0) | 56 (33.6) | 12 (37.5) | 14 (46.7) |
Study team factors | |||||||||
Motivation of MAGNETIC study team at site | 131 (78.9) | 25 (80.6) | 22 (73.3) | 14 (8.4) | 3 (9.7) | 1 (3.3) | 21 (12.6) | 3 (9.7) | 7 (23.3) |
Communication and coordination between study team members at site | 123 (74.5) | 24 (77.4) | 22 (73.3) | 25 (15.2) | 6 (19.4) | 2 (6.7) | 17 (10.2) | 1 (3.2) | 6 (20.0) |
Communication and coordination between study team at site and CTU | 103 (62.1) | 19 (61.3) | 27 (90.0) | 49 (29.5) | 9 (29) | 3 (10.0) | 14 (8.4) | 3 (9.7) | 0 (0) |
Research experience of PI and study team members at site | 105 (63.3) | 19 (61.3) | 21 (70.0) | 38 (22.9) | 7 (22.6) | 3 (10.0) | 23 (13.8) | 5 (16.1) | 6 (20.0) |