The delivery of clinical trial information to prospective participants is a requirement of gaining informed consent. Traditionally, printed information has been given to prospective participants, however, it has been suggested that other methods of information delivery may be more suitable, particularly for adolescent participants. Multimedia information, such as information presented via websites, animations and videos, may improve flexibility in the way information is delivered and therefore increase engagement of adolescents in research. This age group have become familiar with digital information, however, it is not clear if multimedia is the preferred method of information delivery, or if traditional printed information is preferred.
The Bone Anchored Maxillary Protraction (BAMP) trial was a hypothetical trial made to assess patient’s understanding of a particular surgical intervention to treat class III malocclusions and class III skeletal relationships in adolescents. BAMP is a surgical procedure involving the use of titanium mini-plates placed in the zygomatic buttress and lower lateral incisor and canine region to encourage maxillary protraction without the use of headgear.
The aim of this randomised controlled trial was to compare the use of multimedia websites and printed information for their quality and ease of understanding, as well as their impact on decision making amongst adolescents.
This randomised controlled trial included 109 participants between the age of 11-14 years who were receiving orthodontic treatment. The study used a two arm parallel-group and a randomised number generator was used to randomise participants into either group. One group received information about the BAMP trial from an NHS REC approved participant information sheet (ISP). The other group received information on a multimedia website (MMI) which was accessed on a tablet computer (all of the information given on the ISP could be accessed on the tablet, as well as animations and ‘talking head’ videos).
Each group were given as long as they required to review their given resource before they were given a printed Decision-Making Questionnaire (DMQ) to complete, which asked participants to rate various aspects of the information provided and its impact on their decisions regarding the trial. Parents in attendance could also access the information and complete the DMQ with them. Both groups were also given three free-text questions to allow for suggestions or comments about the trial and resources used.
A power calculation was used for the sample size (90% power estimated). Analyses were conducted on an intention-to-treat basis using two-sided tests at the 5% significance level. Total DMQ scores for the ISP and MMI groups were compared using a linear regression model and a sensitivity analysis was conducted using only participants that had responded to all nine DMQ questions. Scores on each question between the two groups were compared using the Wilcoxon Mann-Whitney tests. Free text answers were analysed statistically (based on the number of participants giving positive/negative reposnses and also descriptively, using a basic content analysis) and an odds ratio comparing the number of positive responses between the groups was given.
• 109 participants were randomised (55 to ISP and 54 to MMI); 5 participants did not complete any questions and were not included
- The overall mean score for the DMQ score for both groups was 27.5 +/- 4.3 (maximum DMQ score of 36)
- The mean score was higher in the multimedia resources group (28.1 +/- 4.2) than the paper information group (27.0 +/- 4.3)
- A linear regression showed no difference between the groups (adjusted mean difference (AMD) 0.99 (95% CI = -0.66 to 2.64; P=0.24)) and a sensitivity analysis also showed no difference (AMD 1.06 (95% CI = -0.63 to 2.74; P=0.22)
- Statistically signifcant differences were found to favour the MMI group in two of the DMQ questions:
- ‘the information I saw about the BAMP trial was easy to understand’ (P=0.003)
- ‘I am confident that I have made the right decision about whether or not to take part in the BAMP trial’ (P=0.044)
- There were no statistically significant differences in the other seven questions on the DMQ
- In the free-text questions, there were no statistically significant differences between the groups (odds ratio [OR] = 1.50; 95% CI = 0.68-3.30; P=0.32)
The authors concluded: –
The results of this small trial, using a hypothetical scenario, show that multimedia information (such as websites) can provide information to potential trial participants at least as well as printed information, and it may improve ease of understanding, decisional confidence and other subjective evaluations.
The result of the study showed that multimedia resources increased participants understanding as well as their confidence in making decisions about the treatment and involvement in the trial compared to printed information. The majority of results from this trial, however, were shown not to be statistically significant and highlights a need for further trials with larger sample sizes. The difference in results between the ISP and MMI groups was smaller than the study had anticipated. Other studies in the use of multimedia for trial recruitment have recorded better comprehension and retention of information from multimedia, however, none of these studies were conducted in children and adolescents. A possible reason for this could be the fact that participants in this trial were patients who were already receiving orthodontic treatment and therefore may have a better initial understanding of the orthodontic treatment journey. This initial knowledge could skew results in favour of participants having a better understanding of the information provided, which may explain the small difference in both multimedia and paper information groups. The high completion rate and favourable responses recorded in this randomised controlled trial may be attributed to the participants desire to please their orthodontist. A more realistic result may be achieved by using participants who have not yet started orthodontic treatment to compare differences between both groups.
This is an interesting area of research and, as technology and multimedia becomes more incorporated into everyday life, shows promise as a tool to use to provide patient information regarding their treatment and participation in clinical trials in the future.
Knapp P, Mandall N, Hulse W, Roche J, Moe-Byrne T, Martin-Kerry J, Sheridan R, Higgins S; (for the TRECA study group). Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial. J Orthod. 2021 Dec;48(4):343-351. doi: 10. 10.1177/14653125211024250. Epub 2021 Jul 6. PMID: 34227411; PMCID: PMC8652365.
Thoma A, Farrokhyar F, McKnight L, Bhandari M. Practical tips for surgical research: how to optimize patient recruitment. Can J Surg. 2010 Jun;53(3):205-10. PMID: 20507795; PMCID: PMC2878987.