Acetylsalicylic acid (aspirin) for schizophrenia.

BACKGROUND: Schizophrenia is a serious chronic mental illness affecting an estimated 21 million people worldwide and there is increasing evidence linking inflammation in the brain to the pathophysiology of schizophrenia. Antipsychotic drugs are the conventional treatment for people with schizophrenia but are not always fully effective. Acetylsalicylic acid (aspirin) is a non-steroidal anti-inflammatory drug (NSAID) with properties that inhibit the proinflammatory status of the brain. Using aspirin as an adjunct (add-on) treatment to antipsychotics or as a stand-alone treatment could be a novel, relatively inexpensive option for people with schizophrenia. OBJECTIVES: To review the effects of acetylsalicylic acid (aspirin) as adjunct (add-on) or as stand-alone treatment for people with schizophrenia. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (last search 8 March 2018) which is based on regular searches of MEDLINE, Embase, PubMed, CINAHL, BIOSIS, AMED, PsycINFO and registries of Clinical Trials. There are no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA: Randomised clinical trials focusing on aspirin for people with schizophrenia. DATA COLLECTION AND ANALYSIS: We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat (ITT) basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE. MAIN RESULTS: We included two studies, both comparing the effects of adding aspirin to standard antipsychotic treatment with adding placebo to standard antipsychotic treatment. We were hoping to find high-quality data for seven main outcomes of importance: clinically important change in global state, mental state, cognitive functioning and quality of life, numbers leaving the study early, incidence of gastrointestinal adverse events and hospital admission. Clinically important change data were not reported. Global state data were reported by one study as 'unspecified problem necessitating change in dose or type of antipsychotics'; there was no clear difference between treatment groups for this outcome (RR 0.75, 95% CI 0.30 to 1.88; studies = 1; participants = 70; very low-quality evidence). Both trials measured mental state using the Positive and Negative Symptom Scale (PANSS), and mean total PANSS endpoint scores favoured the adjunct aspirin group in the medium term (MD -6.56, 95% CI -12.04 to -1.08; studies = 2; participants = 130; very low-quality evidence). Less than 10% of each group's participants left the studies early (for any reason) and by around three months there was no clear difference between numbers leaving early from the aspirin group compared to numbers leaving early from the placebo group suggesting aspirin is acceptable (RR 1.12, 95% CI 0.40 to 3.14; studies = 2; participants = 130; very low-quality evidence). There was some gastric upset in both groups but rates were not clearly different between the treatment groups (RR 1.03, 95% CI 0.55 to 1.94; studies = 1; participants = 70; very low-quality evidence). We are unclear if 'change in hospital status' is an unfavourable outcome or not as one study reported equivocal data (RR 0.56, 95% CI 0.05 to 5.90; studies = 1; participants = 70; very low-quality evidence). It should be noted that all the above results were based on data of very low-quality and were difficult to interpret for clinicians or patients, and that the two studies, completed in the last decade, failed to report any usable outcomes on cognitive functioning or quality of life. AUTHORS' CONCLUSIONS: We highlighted the evidence that some pioneering researchers feel this question is important enough to merit testing in randomised trials. However, we also highlighted that the evidence produced from these trials was weak and inconclusive. It was impossible to draw clear conclusions on the therapeutic value of aspirin for schizophrenia from these short, small and limited trials.

Digital Clinical Communication for Families and Caregivers of Children or Young People With Short- or Long-Term Conditions: Rapid Review.

BACKGROUND: The communication relationship between parents of children or young people with health conditions and health professionals is an important part of treatment, but it is unclear how far the use of digital clinical communication tools may affect this relationship. OBJECTIVE: The objective of our study was to describe, assess the feasibility of, and explore the impact of digital clinical communication between families or caregivers and health professionals. METHODS: We searched the literature using 5 electronic databases. We considered all types of study design published in the English language from January 2009 to August 2015. The population of interest included families and caregivers of children and young people aged less than 26 years with any type of health condition. The intervention was any technology permitting 2-way communication. RESULTS: We included 31 articles. The main designs were randomized controlled trials (RCTs; n=10), cross-sectional studies (n=9), pre- and postintervention uncontrolled (pre/post) studies (n=7), and qualitative interview studies (n=2); 6 had mixed-methods designs. In the majority of cases, we considered the quality rating to be fair. Many different types of health condition were represented. A breadth of digital communication tools were included: videoconferencing or videoconsultation (n=14), and Web messaging or emails (n=12). Health care professionals were mainly therapists or cognitive behavioral therapists (n=10), physicians (n=8), and nurses (n=6). Studies were very heterogeneous in terms of outcomes. Interventions were mainly evaluated using satisfaction or acceptance, or outcomes relating to feasibility. Clinical outcomes were rarely used. The RCTs showed that digital clinical communication had no impact in comparison with standard care. Uncontrolled pre/post studies showed good rates of satisfaction or acceptance. Some economic studies suggested that digital clinical communication may save costs. CONCLUSIONS: This rapid review showed an emerging body of literature on the use of digital clinical communication to improve families' and caregivers' involvement in the health management of children or young people. Further research with appropriate study designs and longer-term outcome measures should be encouraged. TRIAL REGISTRATION: PROSPERO CRD42016035467; http://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD 42016 035467(Archived by WebCite at http://www.webcitation.org/6vpgZU1FU).

A qualitative study of clinicians' experience of a clinical trial for displaced distal radius fractures.

Aims: The aim of this study was to explore clinicians' experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures. Methods: Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis. Results: Analysis of the findings identified the overarching theme of "overcoming obstacles", which described the challenge of alleviating staff concerns about the use of non-surgical casting and recruiting families where there was treatment uncertainty. In order to embed and recruit to the Children's Radius Acute Fracture Fixation Trial (CRAFFT), staff needed to fit the study within clinical practice, work together, negotiate treatment decisions, and support families. Conclusion: Recruiting families to this RCT was challenging because staff were uncertain about longer-term patient outcomes, and the difficulties were exacerbated by interdisciplinary tensions. Strong family and clinician beliefs, coupled with the complex nature of emergency departments and patient pathways that differed site-by-site, served as barriers to recruitment. Cementing a strong research culture, and exploring families' treatment preferences, helped to overcome recruitment obstacles.

Being recovered: a qualitative study of parents' experience of their child's recovery up to a year after a displaced distal radius fracture.

Aims: The aim of this study was to explore parents' experience of their child's recovery, and their thoughts about their decision to enrol their child in a randomized controlled trial (RCT) of surgery versus non-surgical casting for a displaced distal radius fracture. Methods: A total of 20 parents of children from 13 hospitals participating in the RCT took part in an interview five to 11 months after injury. Interviews were informed by phenomenology and analyzed using thematic analysis. Results: Analysis of the findings identified the theme "being recovered", which conveyed: 1) parents' acceptance and belief that their child received the best treatment for them; 2) their memory of the psychological impact of the injury for their child; and 3) their pride in how their child coped with their cast and returned to activities. The process of recovery was underpinned by three elements of experience: accepting the treatment, supporting their child through challenges during recovery, and appreciating their child's resilience. These findings extend our framework that highlights parents' desire to protect their child during early recovery from injury, by making the right decision, worrying about recovery, and comforting their child. Conclusion: By one year after injury, parents in both treatment groups considered their child "recovered". They had overcome early concerns about healing, the appearance of the wrist, and coping after cast removal. Greater educational support for families during recovery would enable parents and their child to cope with the uncertainty of recovery, particularly addressing the loss of confidence, worry about reinjury, and the appearance of their wrist.

A qualitative study exploring the experience of viewing three-dimensional medical images during an orthopaedic outpatient consultation from the perspective of patients, health care professionals, and lay representatives.

RATIONALE, AIMS AND OBJECTIVES: Three-dimensional (3D) medical images are shown to patients during clinical consultations about certain health conditions. However, little is known about patients' experience of viewing them. The aim of this qualitative study was to explore the impact of sharing 3D medical images with patients during a clinical consultation about hip surgery, from the perspective of patients, health care professionals, and lay representatives. METHOD: Interviews were conducted with 14 patients who were shown their own 3D medical images during their clinical consultation and four health care professionals conducting consultations within one orthopaedic outpatient clinic. In addition to interviews, 31 lay representatives participated in six focus groups. The focus groups aimed to gain a broader understanding of the advantages and concerns of showing patients their medical images and to compare 3D and two-dimensional (2D) medical images. Interviews and focus groups were audio-recorded, transcribed verbatim, and analysed using thematic analysis. RESULTS: Three themes were developed from the data: (a) the truthful image, (b) the empowering image, and (c) the unhelpful image. Focus group participants' preference for 3D or 2D images varied between conditions and groups, suggesting that the experience of viewing images may differ between individuals and conditions. CONCLUSIONS: When shown to patients during an orthopaedic clinical consultation, 3D medical images may be an empowering resource. However, in this study, patients and focus group participants perceived medical images as factual and believed they could provide evidence of a diagnoses. This perception could result in overreliance in imaging tests or disregard for other forms of information.

Unattainable equipoise in randomized controlled trials : staff views of a feasibility study of surgical treatments for segmental tibial fractures.

AIMS: To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. METHODS: A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants' experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. RESULTS: The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes: the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident; an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills; and treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment. CONCLUSION: Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity, and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice. Cite this article: Bone Jt Open 2021;2(7):486-492.

A qualitative study of parents' and their child's experience of a medial epicondyle fracture.

AIMS: The aim of this study was to explore parents and young people's experience of having a medial epicondyle fracture, and their thoughts about the uncertainty regarding the optimal treatment. METHODS: Families were identified after being invited to participate in a randomized controlled trial of surgery or no surgery for displaced medial epicondyle fractures of the humerus in children. A purposeful sample of 25 parents (22 females) and five young people (three females, mean age 11 years (7 to 14)) from 15 UK hospitals were interviewed a mean of 39 days (14 to 78) from injury. Qualitative interviews were informed by phenomenology and themes identified to convey participants' experience. RESULTS: The results identify parents' desire to do the best for their child expressed through two themes: 1) 'uncertainty' (being uncertain about the best treatment option); and 2) 'facilitating recovery' (sharing the experience). Parents and young people were shocked when confronted with uncertainty about treatment and they felt responsible for the decision. They searched for further information, drew on their own experience, and struggled to weigh up risks of the treatments. Discussion with surgeons provided crucial support for decision-making, and young people were involved to a varying degree. In facilitating recovery, parents balanced increasing activity with protecting their child, but lacked knowledge about pain management, and how to improve strength and function of the arm. They hoped for a return to normal, including competitive sports. CONCLUSION: Surgeons are aware of the impact of injury on children and their parents; however, they may be less aware of the turmoil created by treatment uncertainty. Confident surgeons who appreciate and contextualize the importance of pre-existing experience and beliefs are best placed to help the family develop confidence to embrace uncertainty, particularly regarding participation in clinical trials. Cite this article: Bone Jt Open 2021;2(6):359-364.

Reamed intramedullary nailing versus circular frame external fixation for segmental tibial fractures (STIFF-F): a mixed methods feasibility study.

BACKGROUND: Segmental tibial fractures are fractures in two or more areas of the tibial diaphysis resulting in a separate intercalary segment of the bone. Surgical fixation is recommended for patients with segmental tibial fractures as non-operative treatment outcomes are poor. The most common surgical interventions are intramedullary nailing (IMN) and circular frame external fixation (CFEF), but evidence about which is better is of poor quality. An adequately powered randomised controlled trial (RCT) to determine optimum treatment is required. STIFF-F aimed to assess the feasibility of a multicentre RCT comparing IMN with CFEF for segmental tibial fracture. METHODS: STIFF-F was a mixed-methods feasibility study comprising a pilot RCT conducted at six UK Major Trauma Centres, qualitative interviews drawing on Phenomenology and an online survey of rehabilitation. The primary outcome was recruitment rate. Patients, 16 years and over, with a segmental tibial fracture (open or closed) deemed suitable for IMN or CFEF were eligible to participate. Randomisation was stratified by site using random permuted blocks of varying sizes. Participant or assessor blinding was not possible. Interviews were undertaken with patients about their experience of injury, treatment, recovery and participation. Staff were interviewed to identify contextual factors affecting trial processes, their experience of recruitment and the treatment pathway. An online survey was developed to understand the rehabilitation context of the treatments. RESULTS: Eleven patients were screened and three recruited to the pilot RCT. Nineteen staff and four patients participated in interviews, and 11 physiotherapists responded to the survey. This study found the following: (i) segmental tibial fractures were rarer than anticipated, (ii) the complexity of the injury, study setup times and surgeon treatment preferences impeded recruitment, (iii) recovery from a segmental tibial fracture is challenging, and rehabilitation protocols are inconsistent and (iv) despite the difficulty recruiting, staff valued this research question and strived to find a way forward. CONCLUSION: The proposed multicentre RCT comparing IMN with CFEF is not feasible. This study highlighted the difficulty of recruiting patients to an RCT of a complex rare injury over a short time period. TRIAL REGISTRATION: The study was registered with the International Standard Randomised Controlled Trials Number Registry: ISRCTN11229660.

A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials.

RATIONALE: Randomised controlled trials (RCTs) of surgical interventions are increasing. Such trials encounter challenges that are not present in RCTs of non-surgical interventions because of the nature of the intervention. Several studies have explored patients' experiences of surgical trials to improve recruitment or identify barriers and facilitators to research in this setting. Synthesizing these studies may reveal further insights or confirm whether saturation of relevant themes has been achieved. OBJECTIVE: This review aimed to understand the experiences of adults who are invited to participate in surgical RCTs. METHOD: MEDLINE, Web of Science, and CINAHL were searched to identify articles meeting the inclusion criteria. Assessment of quality was conducted with studies given an overall quality rating of good, fair, or poor. A segregated approach was used to synthesize the data. This method included a thematic synthesis of the qualitative data and a narrative review of the quantitative data. The findings of both syntheses were then integrated. RESULTS: Thirty-four articles reporting 28 trials were included. This review found that the decision to participate in a surgical trial is influenced by multiple factors including patients' individual circumstances and attitudes, and the characteristics of the trial itself. The study identified three themes which encompass both qualitative and quantitative findings. These themes reveal it was important for patients to i) make sense of the trial and trial processes, ii) weigh up the risks and benefits of their different treatment options and participation, and iii) trust the trial and staff. CONCLUSIONS: A patient-centred approach to trial recruitment may help staff build trusting relationships with patients and address their individual concerns about the trial and the risks and benefits of participation.

Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial.

BACKGROUND: Qualitative research has been used to explore patients' and healthcare professionals' experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury. Little research, however, has explored patients' and healthcare professionals' experiences of surgical RCTs in a trauma setting. This study aimed to understand patients' and staff's experiences of an orthopaedic trauma trial. METHODS: We carried out semi-structured interviews with 11 patients and 24 staff (10 surgeons and 14 research associates) participating in a UK multi-centre feasibility trial comparing intramedullary nails versus distal locking plates for fractures of the distal femur (TrAFFix). Interviews explored patients' experience of TrAFFix and their reason for participating and staffs' experience of recruiting to TrAFFix and trauma trials more generally. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using thematic analysis. RESULTS: Three themes were identified. These were i) navigating research with patients after orthopaedic trauma, ii) knowing that it is the right decision and iii) making it work. These themes reflect: i) how research associates supported and guided patients through the consent process enabling them to participate, ii) the difficulty in engaging surgeons in a trial when individual equipoise and experience of the interventions are low despite the presence of community equipoise and iii) the way in which research teams worked together and encouraged the development of a research culture within the clinical teams in order to facilitate recruitment. CONCLUSIONS: Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs supported patients to enable them to make a decision about participation and assisted in developing a research culture within the team by promoting studies and communicating research to clinical staff. Our findings also reinforce surgeons' difficulty with equipoise and suggest that accepting community equipoise could facilitate recruitment.

A qualitative study of patients' experience of recovery after a distal femoral fracture.

PURPOSE: This qualitative study was conducted as part of a feasibility study for TrAFFix, (ISRCTN92089567), a randomised controlled trial that will compare two surgical interventions used to fix distal femoral fractures. Our aim was to understand patients' experiences of treatment and the early phase of recovery after a distal femoral fracture. While, much is known about the experience of recovery from hip fracture, little is known about whether patients with other lower limb fragility fractures experience the same concerns and challenges. MATERIALS AND METHODS: Semi-structured interviews were conducted with 11 patients participating in TrAFFix or their relative. Interviews were conducted face to face or by telephone. With agreement from participants, interviews were audio recorded and transcribed. Transcripts were analysed inductively using thematic analysis. As part of the user involvement for TrAFFix, we held a focus group with PPI representatives who had experience or knowledge of lower limb fractures, to learn about factors that might influence patients' recovery after a fragility facture. Data from the focus group relevant to themes from our thematic analysis are also presented. RESULTS: Three themes were identified within patients' accounts of their experience. Our data revealed that: i) being informed about treatment and recovery was important to patients; ii) patients muddled through and found ways to manage at home, often needing the support of others; and iii) rehabilitation was arduous for patients who received limited rehabilitative support and at times lacked confidence to follow the instructions that they were given. CONCLUSIONS: Our findings highlight the struggle patients endure while recovering after a distal femoral fracture and the limited rehabilitative support they receive after discharge from hospital. They reinforce the need to ensure a patient feels informed about their treatment and recovery and the need for greater support for patients to manage at home and move with confidence.

Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT.

BACKGROUND: Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. OBJECTIVES: This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. DESIGN: A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. SETTING: Seven NHS hospitals. PARTICIPANTS: Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. INTERVENTIONS: Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion. OUTCOMES: The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation. RESULTS: The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, n = 11; plate, n = 12). The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month. Data completeness of the EQ-5D-5L was estimated at 65% (95% CI 43% to 83%). CONCLUSIONS: This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018;22(25)], which delivered to target and budget. FUTURE WORK: A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. REGISTRATION: Current Controlled Trials ISRCTN92089567. 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. 23, No. 51. See the NIHR Journals Library website for further project information. Funding was also supported by the NIHR Oxford Biomedical Research Centre.

Breaks of the lower end of the thigh bone are increasingly common injuries. Two operations are used to treat these injuries: a rod placed along the centre of the bone or a plate attached to the edge of the bone. It is not clear which is better. We report the results from a study that will help develop the design of a definitive study to test which operation produces the best outcomes for patients. Adult patients with a break at the end of the thigh bone treated in one of seven hospitals were eligible to take part in the study. Participants were treated with one of two operations; the choice was made by chance using a computer program. Participants' basic information and pre-injury health status were recorded and participants were followed up at 6 and 16 weeks. We assessed the rate at which participants agreed to take part in the study and the number who completed follow-up. A value-for-money analysis was performed to determine how to plan this element of a future study. Staff and patients were interviewed about the study processes and the context of the treatments and hospitals to understand how the treatments work and the practicalities of delivering the study. Lower than expected numbers of participants took part in the study; 173 patients were considered for the study, but only 23 agreed to participate. The main reason was that several of the participating surgeons felt strongly that one or the other operation was superior. The rate of follow-up was similar to that of other studies using these treatments. Therefore, the proposed definitive trial is unlikely to be successful if designed in the same way as this feasibility study. Several important considerations that informed the planning of this study were found not to hold true. We believe a modified study could be delivered and could answer this important research question.

Intramedullary nails versus distal locking plates for fracture of the distal femur: results from the Trial of Acute Femoral Fracture Fixation (TrAFFix) randomised feasibility study and process evaluation.

OBJECTIVES: This feasibility study and process evaluation assessed the likely success of a definitive trial of intramedullary fixation with locked retrograde nails versus extramedullary fixation with fixed angle plates for fractures of the distal femur. DESIGN & SETTING: A multicentre, parallel, two-arm, randomised controlled feasibility study with an embedded process evaluation was conducted at seven NHS hospitals in England. Treatment was randomly allocated in 1:1 ratio, stratified by centre and chronic cognitive impairment. Participants, but not surgeons or research staff, were blinded to the allocation. PARTICIPANTS: Patients 18 years and older with a fracture of the distal femur, who their surgeon believed would benefit from internal fixation, were eligible to take part.Participants were allocated to receive either a retrograde intramedullary nail or an anatomical locking plate. OUTCOMES: The primary outcomes for this feasibility study were the recruitment rate and completion rate of the EQ-5D-5L at 4 months post-randomisation. Baseline characteristics, disability rating index, quality of life scores, measurements of social support and self-efficacy, resource use and radiographic assessments were also collected. The views of patients and staff were collected during interviews. RESULTS: Recruitment and data completion were lower than expected. 23 of 82 eligible patients were recruited (nail, 11; plate, 12). The recruitment rate was estimated as 0.42 (95% CI 0.27 to 0.62) participants per centre-month. Data completeness of the EQ-5D-5L at 4 months was 61 per cent (95% CI 43% to 83%). The process evaluation demonstrated that the main barriers to recruitment were variation in treatment pathways across centres, lack of surgeon equipoise and confidence in using both interventions and newly formed research cultures that lacked cohesion. CONCLUSIONS: A modified trial design, with embedded recruitment support intervention, comparing functional outcome in cognitively intact adults who have sustained a fragility fracture of the distal femur is feasible. ETHICS APPROVAL: The Wales Research Ethics Committee 5 approved the study (ref: 16/WA/0225). TRIAL REGISTRATION NUMBER: ISRCTN92089567; Pre-results.

Do medical images aid understanding and recall of medical information? An experimental study comparing the experience of viewing no image, a 2D medical image and a 3D medical image alongside a diagnosis.

OBJECTIVE: This study compared the experience of viewing 3D medical images, 2D medical images and no image presented alongside a diagnosis. METHODS: We conducted two laboratory experiments, each with 126 healthy participants. Participants heard three diagnoses; one accompanied by 3D medical images, one accompanied by 2D medical images and one with no image. Participants completed a questionnaire after each diagnosis rating their experience. In Experiment 2, half of the participants were informed that image interpretation can be susceptible to errors. RESULTS: Participants preferred to view 3D images alongside a diagnosis (p<0.001) and reported greater understanding (p<0.001), perceived accuracy (p<0.001) and increased trust (p<0.001) when the diagnosis was accompanied by an image compared to no image. There was no significant difference in trust between participants who were informed of errors within image interpretation and those who were not. CONCLUSION: When presented alongside a diagnosis, medical images may aid patient understanding, recall and trust in medical information. PRACTICAL CONSIDERATIONS: Medical images may be a powerful resource for patients that could be utilised by clinicians during consultations.