| Literature DB >> 34227411 |
Peter Knapp1, Nicky Mandall2, Wendy Hulse2, Jenny Roche1,3, Thirimon Moe-Byrne1,3, Jacqueline Martin-Kerry1,3, Rebecca Sheridan1,3, Steven Higgins4.
Abstract
OBJECTIVE: To compare two methods of providing information about the Bone Anchored Maxillary Protraction (BAMP) trial: standard printed information and multimedia websites, for their quality and ease of understanding, and impact on decision-making.Entities:
Keywords: adolescents; consent; multimedia information; research ethics; trial
Mesh:
Year: 2021 PMID: 34227411 PMCID: PMC8652365 DOI: 10.1177/14653125211024250
Source DB: PubMed Journal: J Orthod ISSN: 1465-3125
Decision-Making Questionnaire item responses, by trial allocation.
| Very hard | Hard | OK | Easy | Very easy | Missing | ||
|---|---|---|---|---|---|---|---|
| 1. The information I saw about the BAMP trial was easy to understand. | MMI | 0 (0.0) | 1 (1.9) | 8 (14.8) | 30 (55.6) | 13 (24.1) | 2 (3.7) |
| ISP | 0 (0.0) | 2 (3.6) | 20 (36.4) | 25 (45.5) | 5 (9.1) | 3 (5.5) | |
| Overall | 0 (0.0) | 3 (2.8) | 28 (25.7) | 55 (50.5) | 18 (16.5) | 5 (4.6) | |
| Not at all | Not really | Not sure | Yes, mostly | Yes, completely | Missing | ||
| 2. After seeing the information about the BAMP trial I knew what taking part would be like. | MMI | 0 (0.0) | 0 (0.0) | 7 (13.0) | 30 (55.6) | 15 (27.8) | 2 (3.7) |
| ISP | 0 (0.0) | 1 (1.8) | 8 (14.6) | 27 (49.1) | 16 (29.1) | 3 (5.5) | |
| Overall | 0 (0.0) | 1 (0.9) | 15 (13.8) | 57 (52.3) | 31 (28.4) | 5 (4.6) | |
| 3. The information helped me understand how my treatment or care might change if I took part in the BAMP trial. | MMI | 0 (0.0) | 2 (3.7) | 5 (9.3) | 31 (57.4) | 14 (25.9) | 2 (3.7) |
| ISP | 0 (0.0) | 3 (5.5) | 4 (7.3) | 33 (60.0) | 11 (20.0) | 4 (7.3) | |
| Overall | 0 (0.0) | 5 (4.6) | 9 (8.3) | 64 (58.7) | 25 (22.9) | 6 (5.5) | |
| 4. The possible benefits of taking part in the BAMP trial were made clear in the information. | MMI | 0 (0.0) | 1 (1.9) | 9 (16.7) | 19 (35.2) | 23 (42.6) | 2 (3.7) |
| ISP | 0 (0.0) | 2 (3.6) | 4 (7.3) | 29 (52.7) | 17 (30.9) | 3 (5.5) | |
| Overall | 0 (0.0) | 3 (2.8) | 13 (11.9) | 48 (44.0) | 40 (36.7) | 5 (4.6) | |
| 5. The possible disadvantages of taking part in the BAMP trial were made clear in the information. | MMI | 0 (0.0) | 5 (9.3) | 6 (11.1) | 20 (37.0) | 21 (38.9) | 2 (3.7) |
| ISP | 0 (0.0) | 2 (3.6) | 11 (20.0) | 24 (43.6) | 15 (27.3) | 3 (5.5) | |
| Overall | 0 (0.0) | 7 (6.4) | 17 (15.6) | 44 (40.4) | 36 (33.0) | 5 (4.6) | |
| 6. The information about the BAMP trial helped me discuss the trial with the person who asked me to take part (usually a doctor, nurse or researcher). | MMI | 1 (1.9) | 4 (7.4) | 10 (18.5) | 23 (42.6) | 14 (25.9) | 2 (3.7) |
| ISP | 0 (0.0) | 0 (0.0) | 12 (21.8) | 31 (56.4) | 9 (16.4) | 3 (5.5) | |
| Overall | 1 (0.9) | 4 (3.7) | 22 (20.2) | 54 (49.5) | 23 (21.1) | 5 (4.6) | |
| 7. The information about the BAMP trial helped me discuss taking part with my parent(s) or family. | MMI | 1 (1.9) | 1 (1.9) | 6 (11.1) | 32 (59.3) | 12 (22.2) | 2 (3.7) |
| ISP | 0 (0.0) | 1 (1.8) | 12 (21.8) | 26 (47.3) | 13 (23.6) | 3 (5.5) | |
| Overall | 1 (0.9) | 2 (1.8) | 18 (16.5) | 58 (53.2) | 25 (22.9) | 5 (4.6) | |
| 8. I am confident that I have made the right decision about whether or not to take part in the BAMP trial. | MMI | 0 (0.0) | 3 (5.6) | 4 (7.4) | 22 (40.7) | 23 (42.6) | 2 (3.7) |
| ISP | 1 (1.8) | 0 (0.0) | 11 (20.0) | 27 (49.1) | 13 (23.6) | 3 (5.5) | |
| Overall | 1 (0.9) | 3 (2.8) | 15 (13.8) | 49 (45.0) | 36 (33.0) | 5 (4.6) | |
| 9. In all, the information about the BAMP trial helped me make my decision about whether or not to take part. | MMI | 0 (0.0) | 1 (1.9) | 5 (9.3) | 24 (44.4) | 22 (40.7) | 2 (3.7) |
| ISP | 0 (0.0) | 0 (0.0) | 7 (12.7) | 31 (56.4) | 14 (25.5) | 3 (5.5) | |
| Overall | 0 (0.0) | 1 (0.9) | 12 (11.0) | 55 (50.5) | 36 (33.0) | 5 (4.6) |
Values are given as n (%).
BAMP, bone anchored maxillary protraction; ISP, participant information sheet; MMI, multimedia website.
Figure 1.Trial CONSORT diagram.
Figure 2.Box plot of total scores on the Decision-Making Questionnaire scale.
Exploratory analysis of each question in the Decision-Making Questionnaire.
| Question | Allocation | N | Median (IQR) | Z-statistic | |
|---|---|---|---|---|---|
| Q1 The information I saw about the BAMP trial was easy to understand. | ISP | 52 | 3 (1) | −3.03 | 0.002 |
| MMI | 52 | 3 (0.5) | |||
| Q2 After seeing the information about the BAMP trial I knew what taking part would be like. | ISP | 52 | 3 (1) | −0.13 | 0.940 |
| MMI | 52 | 3 (1) | |||
| Q3 The information helped me understand how my treatment or care might change if I took part in the BAMP trial. | ISP | 51 | 3 (0) | −0.52 | 0.601 |
| MMI | 52 | 3 (1) | |||
| Q4 The possible benefits of taking part in the BAMP trial were made clear in the information. | ISP | 52 | 3 (1) | −0.53 | 0.602 |
| MMI | 52 | 3 (1) | |||
| Q5 The possible disadvantages of taking part in the BAMP trial were made clear in the information. | ISP | 52 | 3 (1.5) | −0.92 | 0.362 |
| MMI | 52 | 3 (1) | |||
| Q6 The information about the BAMP trial helped me discuss the trial with the person who asked me to take part (usually a doctor, nurse or researcher). | ISP | 52 | 3 (0) | −0.04 | 0.981 |
| MMI | 52 | 3 (2) | |||
| Q7 The information about the BAMP trial helped me discuss taking part with my parent(s) or family. | ISP | 52 | 3 (1) | −0.50 | 0.647 |
| MMI | 52 | 3 (0) | |||
| Q8 I am confident that I have made the right decision about whether or not to take part in the BAMP trial. | ISP | 52 | 3 (0.5) | −2.00 | 0.044 |
| MMI | 52 | 3 (1) | |||
| Q9 In all, the information about the BAMP trial helped me make my decision about whether or not to take part. | ISP | 52 | 3 (1) | −1.41 | 0.160 |
| MMI | 52 | 3 (1) |
BAMP, bone anchored maxillary protraction; ISP, participant information sheet; MMI, multimedia website.