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Abstract Background Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making. Methods We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis. Results Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation. Conclusions Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.

Background The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people. Objectives The study objectives were as follows: to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets. Design Two-phase study: multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement multimedia information resources’ evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people. Setting United Kingdom trials involving patients aged under 18. Participants Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials). Interventions Multimedia information resources (comprising text, audio, ‘talking heads’ video, trial-specific and trial-generic animations). Printed participant information sheets. Main outcome measures Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis. Results Phase 1 generated two multimedia information resource templates: (1) for children aged 6–11 years; (2) for children aged 12–18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of ‘information was easy to understand’ (Z = 3.03; p = 0.003) and ‘I had confidence in decision-making’ (Z = 2.00; p = 0.044) than printed participant information sheet-only provision. Limitations It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings. Conclusions Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets. Future work There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents. Study registration This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information. Plain language summary Clinical trials are important to National Health Service care, but it can be difficult to recruit enough people. We do not know enough about how to improve recruitment, especially when trying to recruit children and young people. People are normally told about a trial through printed information, which is often long and complex. Multimedia information (text, audio, cartoons and video) might be a better way of telling people. It is important to test whether multimedia interventions can help. One way of doing this is to run a ‘Study Within A Trial’ where people receive information in different ways. We created two multimedia interventions, one for parents and young people being asked for consent, and a simpler one for younger children. Some content applied to all trials, and some about the specific trial people were being asked to consider. We designed these by working closely with children and young people, parents and healthcare staff. We tested the multimedia information in six trials (although only three gave us enough data). Children, young people and their parents saw either standard printed information or our multimedia information. We then collected data on their decision-making, trial recruitment and whether people stayed in the trial. Children and young people who saw multimedia information were more likely to be recruited than those who received standard printed information. Once recruited to a trial, people given multimedia or printed information were similarly likely to remain in the trial. People’s views on multimedia and printed information were also similar, but this finding could have been affected by small numbers of people returning questionnaires. Our study provides evidence that multimedia information can be used in trials with children and young people and that it increases the number of people who agree to take part, but further work is needed. Scientific summary Background There is insufficient evidence on how we should treat children and young people across a range of health conditions, in part due to a lack of trial evidence. The information provided to potential trial participants plays a crucial role in their decision-making about participation. In most cases, mandated recruitment information is provided to patients as printed participant information sheets, which have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information digitally, enabling the use of multimedia information in trial recruitment, that is, through animations, video, audio, diagrams and photos, as well as written text. There is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people. Objectives The study objectives were as follows: to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials to obtain and analyse qualitative data from interviews and focus groups with members of key stakeholder groups (i.e. young patients; parents or guardians; and clinicians) to ensure the content, format and delivery of the multimedia information resources reflect their preferences to user-test the multimedia information resources with children and young people (and parents/guardians), to test the ability of the multimedia information resources to inform potential users to establish a Patient and Parent Advisory Group and actively liaise with them in the development and evaluation of the multimedia information resources to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information, and the provision of multimedia information resources in addition to printed participant information. Methods The study involved a two-phase design: development of the multimedia information resources, followed by evaluation. The Phase 1 development included the following four elements: A qualitative study with stakeholder groups, who participated across a two-round study. In the first round, participants discussed information priorities in relation to trial recruitment, and preferences for multimedia information resource appearance and content. In the second round, participants commented on a prototype multimedia information resource for a trial. Data collection used individual or joint interviews, and focus discussion groups. Data analysis was initially deductive descriptive, to rapidly inform the multimedia information resource development; subsequent analyses were iterative and thematic. A user testing study involved performance-based testing on two versions of the prototype trial multimedia information resource, one for children aged 6–11 and the other for children aged 12–18 and parents. Participants used one of two prototype multimedia information resources to answer ten factual questions on its content. For each question participants had to find the relevant information in the multimedia information resource and, once found, show their understanding. Amending the written text within the multimedia information resources. Enhanced patient and parent involvement. The Phase 2 evaluation phase comprised a series of Studies Within A Trial within six host trials recruiting children and young people. Participants were randomised to receive trial recruitment information in one of three formats: multimedia information resource-only; participant information sheet-only; or combined multimedia information resource and participant information sheet. The primary outcome was trial recruitment in the multimedia information resource-only versus the participant information sheet-only arms. Secondary outcomes were as follows: trial retention; participant decision-making (assessed by Likert scale); and trial recruitment, trial retention and participant decision-making when comparing combined multimedia information resource and participant information sheet with participant information sheet-only. Data from the Studies Within A Trial were combined in a pre-planned statistical meta-analysis. We also undertook a trial in a hypothetical trial setting, comparing the effects on multimedia information resource-only and participant information sheet-only provision on decision-making quality. Results Qualitative study Participants were 62 individuals (21 children and young with long-term health conditions, aged 6–19; 24 parents; 17 clinicians or researchers) who took part across a two-round study. Participants emphasised the need for the views of children and young people to be central to multimedia information resource design. Content seen as important included the following: that leaving a trial was ok; what participation would involve; ensuring that multimedia information resource imagery was not ‘scary’; what the trial was testing; potential risks associated with the trial; possible benefits of participation; confidentiality. Sources of trial funding, and payments to participants were seen as less important. They wanted multimedia information resources to be colourful but also appear ‘professional’. They selected from a choice of animation character sets. They had strong preferences for: plain fonts; clear multimedia information resource structure; concise animations with engaging voiceover. A strong theme was being able to identify with participation, possibly through use of video testimony from trial leaders, participants and parents. There were mixed views on interactivity within the multimedia information resources. User testing The first round of testing involved 26 participants (seven children aged 7–11 with a parent; six adolescents aged 12–17; seven parents of adolescents). Ninety-two per cent of information was found without difficulty, and comprehension was high (85% answered all correct). Following minor revisions to wording and layout of the multimedia information resources, they were tested in round 2 with 26 new participants (seven children aged 7–11 with a parent; six adolescents aged 12–17; seven parents of adolescents). Ninety-three per cent of information was found without difficulty, and comprehension was high (95% answered all correct). Following the second user testing round, changes were made to layout of multimedia information resource ‘tabs’ and further information was added on potential risks and contacting trial personnel. Amending the written text within the multimedia information resources involved using the approved version of the trial participant information sheet and rewriting (through plain English and readability metrics, to ensure it was age-appropriate) and restructuring (through reduced number of headings, to aid navigation). Enhanced patient and parent involvement through the formation of a Patient and Parent Advisory Group comprising three people aged 19–24 with long-term health conditions, and three parents of young people with long-term health conditions. The Patient and Parent Advisory Group met three-monthly throughout the study and, between meetings, provided feedback on planned methods, multimedia information resource written content, and animation characters and storyboards. The Phase 1 development phase informed two template multimedia information resources (one for children and young people aged 6–11; one for children and young people aged 12–18 and parents), which would include all written text of the trial participant information sheet, short ‘talking head’ videos with trial personnel and a participant, and five short, animated videos with voiceover (an explainer, which was trial-specific; and four that were trial-generic, explaining aspects of trials). SWAT evaluation The Phase 2 evaluation phase comprised six Studies Within A Trial within different host trials, plus a small randomised controlled trial with adolescents asked to imagine themselves being recruited to a trial. In the Study Within A Trial potential host trial participants were randomly allocated to receive recruitment information as follows: participant information sheet-only; multimedia information resource-only; or combined multimedia information resource and participant information sheet. The multimedia information resources were accessed on PC, laptop, tablet computer or phone. The six host trials were recruiting children and young people with a range of ages and health conditions. Three of the Studies Within A Trial generated sufficient data for logistic regression models, which were combined within a preplanned statistical meta-analysis. Unfortunately, three Studies Within A Trial could not be used to generate logistic regression models, due to being too small (n = 2) or having insufficient variation in outcomes (n = 1). Meta-analysis was based on three Studies Within A Trial (total n = 1758). Providing potential trial participants with multimedia information resource rather than participant information sheet resulted in an increase in trial recruitment (OR = 1.54; 95% CI 1.05 to 2.28; p = 0.03; I2 = 0%), which was statistically significant. It resulted in no increase in rates of retention in trials (OR = 1.29; 95% CI 0.36 to 4.65; p = 0.70; I2 = 0%), assessed at 6 weeks to 6 months after randomisation in the host trial. Decision-Making Questionnaire scores were the same in the multimedia information resource-only and participant information sheet-only arms: adjusted mean difference –0.79 (95% CI –2.80 to 1.22; p = 0.44; I2 = 53.6%). Providing potential trial participants with combined multimedia information resource and participant information sheet rather than participant information sheet-only did not result in an increase in trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; p = 0.67; I2 = 0%) or trial retention (OR = 2.18; 95% CI 0.48 to 10.00; p = 0.31; I2 = 0%). Providing combined multimedia information resource and participant information sheet resulted in lower Decision-Making Questionnaire scores (OR = –2.07; 95% CI –4.13 to –0.01; p = 0.05; I2 = 0%), which was borderline statistically significant. Rates of Decision-Making Questionnaire scores in the Study Within A Trial was low, particularly among those who declined host trial recruitment. In the trial undertaken in a hypothetical setting, multimedia information resource-only provision produced higher ratings of ‘information was easy to understand’ (Z = 3.03; p = 0.003) and ‘I had confidence in decision-making’ (Z = 2.00; p = 0.044) than participant information sheet-only provision, with no differences between arms on the other seven questionnaire items. Conclusions The study produced two multimedia information resource templates (one for younger children aged 6–11; and one for older children aged 12–18 and parents), which were informed by significant empirical co-design work to ensure they met the preferences and information needs of potential trial participants and those recruiting them. The qualitative study found that children and young people, and their parents, said they would place high value on knowing about the experiences of trial participation, when making consent decisions themselves. Trials should consider including short video, audio or written accounts from trial personnel and current trial participants in their recruitment information. The multimedia information resources were acceptable to host trials and Research Ethics Committees, and there was no evidence of resistance to this format of recruitment information. Six Studies Within A Trial were undertaken with host trials recruiting children and young people; three were successful in providing data but three were not successful due to funding, governance and COVID-19 challenges to recruitment. Providing multimedia trial information rather than standard participant information sheets increased trial recruitment rates, which could reduce trial recruitment periods. Trials should consider using multimedia information as an alternative to print, although further evaluation is needed before it can be recommended for routine use. Providing multimedia trial information rather than standard participant information sheets did not increase trial retention or quality of participant decision-making. Providing multimedia trial information in addition to standard participant information sheets did not increase trial recruitment or retention, and resulted in lesser quality of participant decision-making, and it does not appear to be beneficial for trials to develop both formats of information for concurrent provision to potential participants, although further evidence is needed to test this conclusion. Further evaluation of the use of multimedia information in trial recruitment involving other population groups (including trials involving adults) is needed, as the current evidence base is lacking. There is a need for research to evaluate which elements of multimedia information are used by potential trial participants when making consent decisions. There is a need for research to evaluate the impact of multimedia information on communication between potential trial participants and those involved in recruiting them. Research studies using novel information formats in research recruitment or retention processes should ideally use a form of co-design and/or user testing before implementing the information. Study registration This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.

Abstract Background Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and related complications. INFIX is a pelvic fixation device used in younger patients with high-energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients’ ability to mobilise and reduce the risk of immobility-related complications. However, there is a risk of complications related to surgery, and robust evidence is required on patient outcomes. This study will investigate the clinical and cost-effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications. Discussion The L1FE study aims to compare the clinical and cost-effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision-making and allocation of NHS resources. Trial registration International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019

Objectives To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.Design Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.Setting Emergency departments in 23 UK hospitals.Participants 1409 children aged 4–16 years attending with a torus (buckle) fracture, and their parents/guardian. Children’s mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language.Interventions Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728).Outcome measures Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three ‘free text’ questions (deriving subjective evaluations) and trial retention.Results MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI −1.23 to 1.32, p=0.94). The MMI group was more likely to report the information ‘very easy’ to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks’ timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).Conclusions MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively.Trial registration number ISRCTN73136092 and ISRCTN13955395.

Abstract Background Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga’s Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. Methods This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. Discussion This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity. Trial registration ISRCTN ISRCTN13567538 . Registered on 18 March 2019

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: 2x2 factorial ‘study within a trial’ of including a pen and/or £5 (GBP) in cash with a postal recruitment pack to increase the number of participants randomised into the host trial (‘Gentle Years Yoga’) for older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant randomised. Binary data were analysed using logistic regression and time to return using Cox proportional hazards regression. Results: 818 potential host trial participants were included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the proportion of participants randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63–3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75–1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77–1.55). Between those sent £5 (n=409) and not sent £5 (n=409), there was no evidence of increased randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54–2.57), but more screening forms were returned (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13–2.45) and there was decreased time to return screening form (HR 1.56, 95% CI 1.09–2.22). No significant interaction between the interventions was observed. The cost per additional participant randomised was £32 and £1000 for the pen and £5, respectively. Conclusion: A small, monetary incentive did not result in more participants being randomised into the host trial but did encourage increased and faster response to the recruitment invitation. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens were cheaper but did not provide evidence of benefit.

Background: There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae between the 10th thoracic vertebra and the second lumbar vertebra without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty about whether surgical or conservative management is best for stable fractures. Objectives: To assess the feasibility of a definitive randomised controlled trial comparing surgical fixation with initial conservative management of stable thoracolumbar fractures without spinal cord injury. Design: External randomised feasibility study, qualitative study and national survey. Setting: Three NHS hospitals. Methods: A feasibility randomised controlled trial using block randomisation, stratified by centre and type of injury (high- or low-energy trauma) to allocate participants 1 : 1 to surgery or conservative treatment; a costing analysis; a national survey of spine surgeons; and a qualitative study with clinicians, recruiting staff and patients. Participants: Adults aged ≥ 16 years with a high- or low-energy fracture of the body of a thoracolumbar vertebra between the 10th thoracic vertebra and the second lumbar vertebra, confirmed by radiography, computerised tomography or magnetic resonance imaging, with at least one of the following: kyphotic angle > 20° on weight-bearing radiographs or > 15° on a supine radiograph or on computerised tomography; reduction in vertebral body height of 25%; a fracture line propagating through the posterior wall of the vertebra; involvement of two contiguous vertebrae; or injury to the posterior longitudinal ligament or annulus in addition to the body fracture. Interventions: Surgical fixation: open spinal surgery (with or without spinal fusion) or minimally invasive stabilisation surgery. Conservative management: mobilisation with or without a brace. Main outcome measure: Recruitment rate (proportion of eligible participants randomised). Results: Twelve patients were randomised (surgery, n = 8; conservative, n = 4). The proportion of eligible patients recruited was 0.43 (95% confidence interval 0.24 to 0.63) over a combined total of 30.7 recruitment months. Of 211 patients screened, 28 (13.3%) fulfilled the eligibility criteria. Patients in the qualitative study (n = 5) expressed strong preferences for surgical treatment, and identified provision of information about treatment and recovery and when and how they are approached for consent as important. Nineteen surgeons and site staff participated in the qualitative study. Key themes were the lack of clinical consensus regarding the implementation of the eligibility criteria in practice and what constitutes a stable fracture, alongside lack of equipoise regarding treatment. Based on the feasibility study eligibility criteria, 77% (50/65) and 70% (46/66) of surgeons participating in the survey were willing to randomise for high- and low-energy fractures, respectively. Limitations: Owing to the small number of participants, there is substantial uncertainty around the recruitment rate. Conclusions: A definitive trial is unlikely to be feasible currently, mainly because of the small number of patients meeting the eligibility criteria. The recruitment and follow-up rates were slightly lower than anticipated; however, there is room to increase these based on information gathered and the support within the surgical community for a future trial. Future work: Development of consensus regarding the population of interest for a trial. Trial registration: Current Controlled Trials ISRCTN12094890. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 62. See the NIHR Journals Library website for further project information.

Background: Poor response to questionnaires collecting outcome data in randomised controlled trials (RCTs) can affect the validity of trial results. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of including a pen with a follow-up postal questionnaire on response rate. Methods: A two-armed RCT was embedded within SSHeW (Stopping Slips among Healthcare Workers), a trial of slip-resistant footwear to reduce slips in NHS staff. Participants were randomised 1:1 to receive a pen or no pen with their follow-up questionnaire. The primary outcome was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, and whether a postal reminder notice was required. Data were analysed using logistic regression, linear regression and Cox proportional hazards regression. Results: Overall, 1466 SSHEW trial participants were randomised into the SWAT. In total, 13 withdrew from the host trial before they were due to be sent their follow-up questionnaire, 728 participants received a pen with their questionnaire, and 725 did not receive a pen. A questionnaire was returned from 67.7% of the pen group and 64.7% of the group who did not receive a pen. There was no significant difference in return rates between the two groups (OR 1.15, 95% CI 0.92 to 1.43, p=0.22), nor level of completeness of the questionnaires (AMD -0.01, 95% CI 0.06 to 0.05, p=0.77). There was weak evidence of a reduction in the proportion of participants requiring a reminder and in time to response in the pen group. Conclusion: Inclusion of a pen with the follow-up postal questionnaire sent to participants in the SSHeW trial did not statistically significantly increase the response rate. These results add to the body of evidence around improving response rates in trials. Trial registration: ISRCTN 33051393 (for SSHEW). Registered on 14/03/2017.

Through a consideration of audience experience of embodiment in contemporary dance performance, this project used kinesthetic empathy as a theoretical construct to inform choreographic decision-making. The research outcome challenged the traditional performer/audience relationship through an interactive dance performance work entitled 'Planets. 'This acted as a platform that allowed both audience and performer to collaboratively listen to, process and form movement in a shared kinesthetic state. This connection was enabled through the distribution of interactive art objects, which responded to the shifting proximity between performer and audience. The performance was thus experienced through following a shared goal as instigated by the interactive technology. Through practice-led research, knowledge from kinesthetic empathy, embodied cognition and the mirror neuron system were used to develop the project’s aim in encouraging interactive audiences to engage in movement. This aim influenced studio explorations of movement through an enquiry into the kinesthetic self in dance. Investigations used movement quality, tension, mobility and acceleration to access a familiar movement vocabulary appropriate for a broad interactive audience. This informed the role of the researcher as performer. 'Planets 'was developed as a collaborative project between Michael Smith and interactive visual designer Andy Bates and performed over three nights at the Ars Electronica Festival 2014 in Linz, Austria. Supported by documented footage from 'Planets 'and audience responses to the performances', 'this paper draws together the theoretical underpinnings behind the development of the work and includes the experiential perspective of the performer.

Background: Digital multimedia information (MMI) has potential for use in trial recruitment but there is little formal evaluation. The objectives were to evaluate digital MMI about a trial for its effects on recruitment, retention, participation decisions, and patients’ acceptability, compared with printed information (PIS) alone and when combined with PIS. Methods: SWAT (study within a trial) using random parallel-group individual allocation within the Thermic-3 trial evaluating warm versus cold cardioplegia solution during cardiac surgery. Set in one UK hospital, participants were 147 children (0-16 years) awaiting surgery for congenital heart defects; 38% were female. Participants and their parents/guardian received trial information via multimedia (including text, animated videos and talking-head videos) for viewing at home (MMI group; n=49), or PIS (PIS group; n=47), or both (PIS&MMI group; n=51). Primary outcome was recruitment rate to the Thermic-3 trial comparing PIS-alone and MMI-alone. Secondary outcomes were recruitment rate comparing PIS-alone and combined PIS&MMI; Decision-Making Questionnaire; 3 ‘free-text’ questions (deriving subjective evaluations); trial retention. Results: MMI produced a 14.2% absolute increase in recruitment, which was not statistically significant: 32 (65.3%) participants were recruited from the MMI group; 24 (51.1%) from the PIS group (OR 1.80; 95% CI 0.79 to 4.10, p = 0.16); and 22 from the PIS&MMI group. There was no difference in recruitment through combined PIS&MMI (43.1% vs 51.1%; OR 0.73; 95% CI 0.33 to 1.61; p= 0.43). Questionnaires were returned by 17 (12%) participants and analysed descriptively. Trial retention (at 3 months) was high in all groups (72/77; 93.5% overall) and there was no difference due to information format received before participating. Conclusions: MMI increased recruitment to the Thermic-3 trial but the difference was not statistically significant, and the SWAT was small. Trial registration: TRECA ISRCTN73136092 and NI Hub for Trials Methodology Research SWAT Repository (SWAT 97). Thermic-3: ISRCTN13467772.

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: 2x2 factorial ‘study within a trial’ of including a pen and/or £5 (GBP) in cash with a postal recruitment pack to increase the number of participants randomised into the host trial (‘Gentle Years Yoga’) for older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant randomised. Binary data were analysed using logistic regression and time to return using Cox proportional hazards regression. Results: 818 potential host trial participants were included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the proportion of participants randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63–3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75–1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77–1.55). Between those sent £5 (n=409) and not sent £5 (n=409), there was no evidence of increased randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54–2.57), but more screening forms were returned (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13–2.45) and there was decreased time to return screening form (HR 1.56, 95% CI 1.09–2.22). No significant interaction between the interventions was observed. The cost per additional participant randomised was £32 and £1000 for the pen and £5, respectively. Conclusion: A small, monetary incentive did not result in more participants being randomised into the host trial but did encourage increased and faster response to the recruitment invitation. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens were cheaper but did not provide evidence of benefit.

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: This was a 2x2 factorial ‘study within a trial’ of including a pen and/or £5 with a postal recruitment pack to improve randomisation rate (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression. Results: 818 potential host trial participants included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63–3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75–1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77–1.55). There was evidence of improved screening return rates (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13–2.45) and time to return screening form (HR 1.56, 95% CI 1.09–2.22) but not randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54–2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive. Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.