Table 2 Proportion of studies reporting information relevant to the 12 TIDieR checklist items and item-specific intervention details (n = 122)
Original TIDieR element | Descriptive item | Frequency (% of studies) for which descriptive item was extractable |
|---|---|---|
1. Name/description | Description of intervention | 122 (100.0) |
Example: | “The CI [coaching intervention] was to provide flexible, individualized, nondirective basic education and support for patients in order to create a context of trust that promoted clinical trial enrollment.” [73] | |
2. Why (rationale) | Intervention rationale information | 122 (100.0) |
Item details: | Rationale linked to intervention: | |
Rationale linked | 68 (55.7) | |
No clear link | 38 (31.1) | |
Not applicable | 16 (13.1) | |
3. What (materials) | Materials information | 122 (100.0) |
Item details: | Materials used: | |
Modified recruitment document | 41 (33.6) | |
None | 16 (13.1) | |
Additional recruitment document | 15 (12.3) | |
Video | 15 (12.3) | |
Computer program/site | 11 (9.0) | |
Recruiter materials | 9 (7.4) | |
Other (e.g., incentives, SMS messages) | 15 (12.3) | |
Item details: | Materials access provided: | |
No/partial materials access | 80 (65.6) | |
Access to full materials | 31 (25.4) | |
Not applicable | 11 (9.0) | |
4. What (procedure) | Intervention design information | 122 (100.0) |
Item details: | Intervention design, ORRCA categories: | |
Modified information | 67 (54.9) | |
Modification to consent process | 15 (12.3) | |
Host trial design | 13 (10.7) | |
Changes during trial | 10 (8.2) | |
Recruiter/site intervention | 10 (8.2) | |
Incentives | 5 (4.1) | |
Other | 2 (1.6) | |
5. Who (provider) | Intervention provider | 101 (82.8) |
Item details: | Type of intervention provider: | |
Member of research team | 72 (59.0) | |
Member of clinical care team | 20 (16.4) | |
Other | 9 (7.4) | |
Not reported | 21 (17.2) | |
6. How (modes of delivery) | Mode(s) of delivery | 122 (100.0) |
Item details: | Primary mode(s) of delivery:* | |
Informational – Printed material | 57 (46.7) | |
Informational – Electronic | 44 (36.1) | |
Informational – Human Interactional | 29 (23.8) | |
Informational – Audio/visual | 9 (7.4) | |
Environmental change | 3 (4.5) | |
Other | 6 (4.9) | |
7. Where (intervention location) | Intervention location | 115 (94.3) |
Item details: | Location type: | |
Hospital, clinic | 50 (41.0) | |
Non-clinical setting | 39 (32.0) | |
Multiple locations | 7 (5.7) | |
Virtual | 19 (15.6) | |
Not reported | 7 (5.7) | |
8a. Frequency of intervention | Information about frequency | 121 (99.2) |
Item details: | Intervention frequency: | |
One-time event | 110 (90.2) | |
Multiple intervention times | 11 (9.0) | |
Not reported | 1 (0.8) | |
8b. Duration of intervention | Information about duration | 32 (26.2) |
Item details: | Range in reported intervention duration (minutes) | 5–774 |
9. Tailoring | Information about tailoring | 10 (8.2) |
Examples: | “Emails to the clinical sites from the central trial coordinators generally contained highly-tailored site-specific information about recruitment performance relative to goals,…” [32] | |
“The coach provided flexible social support and education addressing (1) general issues in the patient’s life (to establish rapport and show interest in the patient),… and (4) promotion of participation in clinical trials.” [73] | ||
10. Modifications during study | Information about modifications | 0 (0.0) |
11. Planned fidelity/adherence | Information about planned fidelity | 6 (4.9) |
Examples: | “The project coordinator reviewed records weekly to assure protocol adherence.” [37] | |
“The packs were placed in order of the random allocation list and then numbered sequentially by the researcher before being sent to the practice. By numbering the packs, the researcher had a record of which PIL type was in each pack, which enabled the researcher to monitor if packs were sent out in the correct randomized order.” [69] | ||
12. Actual fidelity/adherence | Information about actual fidelity | 17 (13.9) |
Examples: | “A few participants could not complete some of the tasks (17%, 14/89) due to technical or other problems.” [92] | |
“We reported higher reminder delivery in the SMS group (88% delivered) compared with the phone group (67% delivered, 78% if voicemail messages are also included). However, this apparent difference in intervention delivery fidelity is likely to be an artifact of how delivery was measured in each group.” [105] |