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Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded 'study within a trial' aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to this questionnaire. Methods: This study was a two-armed randomised controlled trial nested in the Gentle Years Yoga (GYY) trial. Participants in the intervention group of the GYY trial were allocated 1:1 using simple randomisation to either receive a pen (intervention) or no pen with their 3-month questionnaire (control). The primary outcome was the proportion of participants sent a 3-month questionnaire who returned it. Secondary outcomes were time taken to return the questionnaire, proportion of participants sent a reminder to return the questionnaire, and completeness of the questionnaire. Binary outcomes were analysed using logistic regression, time to return by Cox Proportional Hazards regression and number of items completed by linear regression. Results: There were 111 participants randomised to the pen group and 118 to the no pen group who were sent a 3-month questionnaire. There was no evidence of a difference in return rates between the two groups (pen 107 (96.4%), no pen 117 (99.2%); OR 0.23, 95% CI 0.02 to 2.19, p=0.20). Furthermore, there was no evidence of a difference between the two groups in terms of time to return the questionnaire (HR 0.90, 95% CI 0.69 to 1.18, p=0.47), the proportion of participants sent a reminder (OR 0.85, 95% CI 0.48 to 1.53, p=0.60) nor the number of items completed (mean difference 0.51, 95% CI -0.04 to 1.06, p=0.07). Conclusion: The inclusion of a pen with the postal 3-month follow-up questionnaire did not have a statistically significant effect on response rate.
RESUMO
AIMS: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. METHODS: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods. DISCUSSION: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open 2021;2(3):150-163.
RESUMO
BACKGROUND: Although considered important, the direct involvement of young children in research design is scarce and to our knowledge its impact has never been measured. We aim to demonstrate impact of young children's involvement in improving the understanding of a new 3D eye test or stereotest. METHODS: After a pre-measure of understanding was taken, we explored issues with the test instructions in patient and public involvement (PPI) sessions where children acted as advisers in the test design. Feedback was collected via observations, rating scales and verbal comments. An interdisciplinary panel reviewed the feedback, discussed potential changes to the test design, and decided on the implementation. Subsequently, a post-measure of understanding (Study 1-2) and engagement (Study 3) was collected in a pre-post study design. Six hundred fifty children (2-11.8 years old) took part in the pre-measure, 111 children (1-12 years old) in the subsequent PPI sessions, and 52 children (4-6 years old) in the first post-measure. One hundred twenty-two children (1-12 years old) and unrelated adults took then part in a second series of PPI sessions, and 53 people (2-39 years old) in the final post-measure. Adults were involved to obtain verbal descriptions of the target that could be used to explain the task to children. RESULTS: Following feedback in Study 1, we added a frame cue and included a shuffle animation. This increased the percentage of correct practice trials from 76 to 97% (t (231) = 14.29, p < .001), but more encouragements like 'Keep going!' were needed (t (64) = 8.25, p < .001). After adding a cardboard demo in Study 2, the percentage of correct trials remained stable but the number of additional instructions given decreased (t (103) = 3.72, p < .001) as did the number of encouragements (t (103) = 8.32, p < .001). Therefore, changes in test design following children's feedback significantly improved task understanding. CONCLUSIONS: Our study demonstrates measurable impact of involvement of very young children in research design through accessible activities. The changes implemented following their feedback significantly improved the understanding of our test. Our approach can inform researchers on how to involve young children in research design and can contribute to developing guidelines for involvement of young children in research.
