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Background We applied Motivational Interviewing (MI) techniques, early after stroke, to facilitate psychological adjustment to life post-stroke. In our trial, MI-plus-usual-care increased the likelihood of normal mood at 3-months post-stroke, compared to usual-care alone. Whilst appropriate training, manuals, and supervision may increase adherence to core principles of this complex intervention, unintended variability in implementation inevitably remains. We aimed to explore the impact of variability on participant outcome. Methods Using our trial data (411 participants), we explored variation in MI delivery, examining: therapist characteristics (stroke care expertise/knowledge, psychology training); MI content (fidelity to MI techniques assessed with Motivational Interviewing Treatment Integrity code, describing therapist behaviours as MI-consistent, MI-neutral or MI-inconsistent); and MI dose (number/duration of sessions). Results The four MI therapists (two nurses/two psychologists) had varying expertise and MI delivery. Across therapists, mean average session duration ranged 29.5–47.8 min. The percentage of participants completing the per-protocol four sessions ranged 47%–74%. These variations were not related to participant outcome. There were uniformly high frequencies (>99%) of MI-consistent and MI-neutral interactions, and low frequencies (<1%) of MI-inconsistent interactions. Conclusions Variation in therapist characteristics and MI dose did not affect participant outcome. These may have been tolerated due to high fidelity to MI principles.

Background We applied Motivational Interviewing (MI) techniques, early after stroke, to facilitate psychological adjustment to life post-stroke. In our trial, MI-plus-usual-care increased the likelihood of normal mood at 3-months post-stroke, compared to usual-care alone. Whilst appropriate training, manuals, and supervision may increase adherence to core principles of this complex intervention, unintended variability in implementation inevitably remains. We aimed to explore the impact of variability on participant outcome. Methods Using our trial data (411 participants), we explored variation in MI delivery, examining: therapist characteristics (stroke care expertise/knowledge, psychology training); MI content (fidelity to MI techniques assessed with Motivational Interviewing Treatment Integrity code, describing therapist behaviours as MI-consistent, MI-neutral or MI-inconsistent); and MI dose (number/duration of sessions). Results The four MI therapists (two nurses/two psychologists) had varying expertise and MI delivery. Across therapists, mean average session duration ranged 29.5–47.8 min. The percentage of participants completing the per-protocol four sessions ranged 47%–74%. These variations were not related to participant outcome. There were uniformly high frequencies (>99%) of MI-consistent and MI-neutral interactions, and low frequencies (<1%) of MI-inconsistent interactions. Conclusions Variation in therapist characteristics and MI dose did not affect participant outcome. These may have been tolerated due to high fidelity to MI principles.

Background Despite simpler regimens than vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), adherence (taking drugs as prescribed) and persistence (continuation of drugs) to direct oral anticoagulants are suboptimal, yet understudied in electronic health records (EHRs). Objective We investigated (1) time trends at individual and system levels, and (2) the risk factors for and associations between adherence and persistence. Methods In UK primary care EHR (The Health Information Network 2011–2016), we investigated adherence and persistence at 1 year for oral anticoagulants (OACs) in adults with incident AF. Baseline characteristics were analysed by OAC and adherence/persistence status. Risk factors for non-adherence and non-persistence were assessed using Cox and logistic regression. Patterns of adherence and persistence were analysed. Results Among 36 652 individuals with incident AF, cardiovascular comorbidities (median CHA2DS2VASc[Congestive heart failure, Hypertension, Age≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category] 3) and polypharmacy (median number of drugs 6) were common. Adherence was 55.2% (95% CI 54.6 to 55.7), 51.2% (95% CI 50.6 to 51.8), 66.5% (95% CI 63.7 to 69.2), 63.1% (95% CI 61.8 to 64.4) and 64.7% (95% CI 63.2 to 66.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. One-year persistence was 65.9% (95% CI 65.4 to 66.5), 63.4% (95% CI 62.8 to 64.0), 61.4% (95% CI 58.3 to 64.2), 72.3% (95% CI 70.9 to 73.7) and 78.7% (95% CI 77.1 to 80.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. Risk of non-adherence and non-persistence increased over time at individual and system levels. Increasing comorbidity was associated with reduced risk of non-adherence and non-persistence across all OACs. Overall rates of ‘primary non-adherence’ (stopping after first prescription), ‘non-adherent non-persistence’ and ‘persistent adherence’ were 3.5%, 26.5% and 40.2%, differing across OA

Background: Falls are the leading cause of fatal and non-fatal unintentional injuries in older people. The use of Exergames (active, gamified video-based exercises) is a possible innovative, community-based approach. This study aimed to determine the effectiveness of a tailored OTAGO/FaME based strength and balance Exergame programme for improving balance, maintaining function and reducing falls risk in older people. Methods: A two-arm cluster randomised controlled trial recruiting adults aged 55 years and older living in 18 assisted-living (sheltered housing) facilities (clusters) in the UK. Standard care (physiotherapy advice and leaflet) was compared to a tailored 12-week strength and balance Exergame programme, supported by physiotherapists or trained assistants. Complete-case analysis (intention to treat) was used to compare Berg Balance Scale (BBS) at baseline and at 12 weeks. Secondary outcomes included: fear of falling, mobility, falls risk, pain, mood, fatigue, cognition, healthcare utilisation and health-related quality of life; self-reported physical activity and falls. Results: Eighteen clusters were randomised (9 to each arm) with 56 participants allocated to the intervention and 50 to the control (78% female, mean age 78 years). Fourteen participants withdrew over the 12 weeks (both arms), mainly for ill health. There was an adjusted mean improvement in balance (BBS) of 6.2 (95% CI 2.4 to 10.0), reduced fear of falling (p=0.007) and pain (p=0.02) in Exergame group. Mean attendance at sessions was 69% (mean exercising time of 33 minutes/week). 24% of control group and 20% of Exergame group fell over trial period. The change in falls rates significantly favoured the intervention (incident rate ratio 0.31 (95% CI 0.16 to 0.62, p=0.001)). The point estimate of the incremental cost effectiveness ratio (ICER) was £15,209.80 per QALY. Using 10,000 bootstrap replications, at the lower bound of the NICE threshold of £20,000 per QALY, there was a 61% probability

Background Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI. Objective To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI. Design A multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation. Setting Three NHS major trauma centres (MTCs) in England. Participants Adults with TBI admitted for > 48 hours and working or studying prior to injury. Interventions Early specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model. Main outcome measures Self-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation. Results Out of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC, n = 23; intervention, n = 29), completing 90% of the work questions; 21 out of 23 (91%)

Background Regular outpatient follow-up programmes are usually offered to patients following treatment for gynaecological and other cancers. Despite the substantial resources involved in providing these programmes, there is evidence that routine follow-up programmes do not affect survival or the likelihood of detecting recurrence and may not meet patient needs. Alternative follow-up modalities may offer the same outcomes at lower cost. We examined the costs of using telephone-based routine follow-up of women treated for endometrial cancer undertaken by specialist gynaecology oncology nurses in comparison to routine hospital-based follow-up. Methods The ENDCAT trial randomised 259 women at five centres in the north west of England with a known diagnosis of Stage I endometrial cancer who had completed primary treatment on a 1:1 basis to receive either standard hospital outpatient follow-up or a telephone follow-up intervention administered by specialist nurses. A cost-consequence analysis was undertaken in which we compared costs to the health system and to individuals with the trial’s co-primary outcomes of psychological morbidity and participant satisfaction with information received. Results Psychological morbidity, psychosocial needs, patient satisfaction and quality of life did not differ between arms. Patients randomised to telephone follow-up underwent more and longer consultations. There was no difference in total health service mean per patient costs at 6 months (mean difference £8, 95% percentile confidence interval: − £147 to £141) or 12 months (mean difference: − £77, 95% percentile confidence interval: − £334 to £154). Estimated return journey costs per patient for hospital consultations were £11.47. Productivity costs were approximately twice as high under hospital follow-up. Conclusion Telephone follow-up was estimated to be cost-neutral for the NHS and may free up clinic time for other patients. There was some evidence that telephone follow-up may be m

Lois Thomas, Christine Roffe, Joanne Booth, Christopher Chapple, Caroline Watkins, Brenda Roe, Christopher Sutton, Bruce Hollingsworth, Céu Mateus, David Britt, Cliff Panton and Kina Bennett; for the MRC Continence Programme and R&D Stroke and Incontinence Study

Falls are the leading cause of fatal and non-fatal unintentional injuries in older people. The use of Exergames (active video-games) is a possible innovative, community-based approach to reduce falls risk. The objective of this study was to evaluate the effectiveness of a tailored physiotherapy-based Exergame programme for reducing falls risk in older residents of assisted living facilities in the UK. A multi-site, two-arm cluster randomised controlled trial with 3 month follow up of falls in eighteen assisted-living facilities in the UK was conducted. Tailored 12-week strength and balance Exergame programme, supported by physiotherapists or assistants plus standard care (physio advice and leaflet) against standard care only, in older adults dwelling in assisted living facilities. The primary outcome measure was balance as assessed by the Berg Balance scale (BBS). Secondary outcomes included fear of falling, mobility, pain, falls risk, fatigue, cognition and incidence of falls. Eighteen sites were recruited and randomised to each intervention (106 participants of which 56 Exergames; 50 control). Intention-to-treat analysis revealed that balance was significantly improved at 12 wks in the Exergame group with an adjusted mean increase in BBS of 6.18 (95% CI 2.38 to 9.97) and significant improvements in secondary outcomes of fear of falling and pain. Falls rate was significantly lower in the Exergames group (incidence rate ratio 0.40, (95%CI 0.22 to 0.74, p=0.001). Exergames, as delivered in this trial, improve balance, pain and fear of falling and may be considered as a fall prevention strategy in assistive living facilities for older people.

Objective: To assess 5 physical signs to see whether they can assist in the screening of patients with CFS/ME, and potentially lead to quicker treatment. Methods: This was a diagnostic accuracy study with inter-rater agreement assessment. Participants recruited from 2 NHS hospitals, local CFS/ME support groups and the community were examined by three practitioners on the same day in a randomized order. Two Allied Health Professionals (AHPs) performed independent examinations of physical signs including; postural/mechanical disturbances of the thoracic spine, breast varicosities, tender Perrin’s Point, tender coeliac plexus and dampened cranial flow. A physician conducted a standard clinical neurological and rheumatological assessment, whilst looking for patterns of illness behaviour. Each examination lasted approximately 20 minutes. Results: Ninety-four participants were assessed, 52 CFS/ME patients and 42 non-CFS/ME controls, aged 18-60. Cohen’s kappa revealed agreement between the AHPs was substantial for presence of the tender coeliac plexus (κ=0.65, p<0.001) and moderate for postural/mechanical disturbance of the thoracic spine (κ=0.57, p<0.001) and Perrin’s point (κ=0.56, p<0.001). A McNemar’s test found no statistically significant bias in the diagnosis by the experienced AHP relative to actual diagnosis, (p=1.0) and a marginally non-significant bias by the newly trained AHP, p=0.052. There was however, a significant bias in the diagnosis made by the physician relative to actual diagnosis, (p<0.001), indicating poor diagnostic utility of the clinical neurological and rheumatological assessment. Conclusions: Using the physical signs appears to improve the accuracy of identifying people with CFS/ME and shows agreement with current diagnostic techniques, however the present study concludes that only 2 of these may be needed. Examining for physical signs is both quick and simple for the AHP and may be used as an efficient screening tool for CFS/ME. This is a small

Web-based interventions to support people to manage long-term health conditions are available and effective but rarely used in clinical services. The aim of this study is to identify critical factors impacting on the implementation of an online supported self-management intervention for relatives of people with recent onset psychosis or bipolar disorder into routine clinical care and to use this information to inform an implementation plan to facilitate widespread use and inform wider implementation of digital health interventions. A multiple case study design within six early intervention in psychosis (EIP) services in England, will be used to test and refine theory-driven hypotheses about factors impacting on implementation of the Relatives' Education And Coping Toolkit (REACT). Qualitative data including behavioural observation, document analysis, and in-depth interviews collected in the first two EIP services (wave 1) and analysed using framework analysis, combined with quantitative data describing levels of use by staff and relatives and impact on relatives' distress and wellbeing, will be used to identify factors impacting on implementation. Consultation via stakeholder workshops with staff and relatives and co-facilitated by relatives in the research team will inform development of an implementation plan to address these factors, which will be evaluated and refined in the four subsequent EIP services in waves 2 and 3. Transferability of the implementation plan to non-participating services will be explored. Observation of implementation in a real world clinical setting, across carefully sampled services, in real time provides a unique opportunity to understand factors impacting on implementation likely to be generalizable to other web-based interventions, as well as informing further development of implementation theories. However, there are inherent challenges in investigating implementation without influencing the process under observation. We outline our s

Background: Arthritis gloves are regularly provided as part of the management of people with rheumatoid arthritis (RA) and undifferentiated (early) inflammatory arthritis (IA). Usually made of nylon and elastane (i.e. Lycra®), these arthritis gloves apply pressure with the aims of relieving hand pain, stiffness and improving hand function. However, a systematic review identified little evidence supporting their use. We therefore designed a trial to compare the effectiveness of the commonest type of arthritis glove provided in the United Kingdom (Isotoner gloves) (intervention) with placebo (control) gloves (i.e. larger arthritis gloves providing similar warmth to the intervention gloves but minimal pressure only) in people with these conditions. Methods: Participants aged 18 years and over with RA or IA and persistent hand pain will be recruited from National Health Service Trusts in the United Kingdom. Following consent, participants will complete a questionnaire booklet, then be randomly allocated to receive intervention or placebo arthritis gloves. Within three weeks, they will be fitted with the allocated gloves by clinical specialist rheumatology occupational therapists. Twelve weeks (i.e. the primary endpoint) after completing the baseline questionnaire, participants will complete a second questionnaire, including the same measures plus additional questions to explore adherence, benefits and problems with glove-wear. A sub-sample of participants from each group will be interviewed at the end of their participation to explore their views of the gloves received. The clinical effectiveness and cost-effectiveness of the intervention, compared to placebo gloves, will be evaluated over 12 weeks. The primary outcome measure is hand pain during activity. Qualitative interviews will be thematically analysed. Discussion: This study will evaluate the commonest type of arthritis glove (Isotoner) provided in the NHS (i.e. the intervention) compared to a placebo glove. The

Background Cardiac arrest outside hospital is a catastrophic medical emergency experienced by an estimated 60 000 people a year in the UK. The speed and accuracy with which cardiac arrest outside hospital is recognised by 999 call handlers is fundamental to improving the chance of survival, but is extremely challenging. We aimed to identify how cardiac arrest is actually described by callers during dialogues with 999 call handlers. Methods Data was obtained from two acute NHS trusts and their two local ambulance trusts for all cases of suspected or actual out-of-hospital cardiac arrest (OHCA) or imminent medically witnessed cardiac arrest (MWCA) which led to transfer to one of the study hospitals, for a one year period (1/7/2013–30/6/2014). The 999 call recordings were listened to in full; words or phrases used by callers to describe clinical signs and symptoms were identified and clustered into key indicator symptoms using a thematic approach. Findings 429 cases of cardiac arrest were identified, of which 246 (57.3%) were dispatched using a ‘cardiac arrest’ code. 6 callers (1.4%) used the term ‘cardiac arrest’ or a synonym. Key indicator symptoms reported most frequently were unconsciousness (64.8%), ineffective breathing (61.9%), and absent breathing (48.8%). Descriptors of conscious level included diverse colloquialisms and terms relating to reduced or fluctuating level of consciousness (17.2%). Descriptors of ineffective breathing included diverse terms relating to slow, fast, irregular, agonal, dyspnoea, and shallow breathing, plus nonspecific terms (e.g. ‘breathing’s funny); and ‘don’t know’ statements. Conclusion Callers’ descriptors of key symptoms of OHCA are varied and include many colloquialisms. Call handler training should include awareness of likely descriptions, particularly of ineffective breathing, which may be more commonly reported than absent breathing.

Background and Aims: Outcomes for stroke patients are improved by reducing time to, and increasing accessibility of, stroke-specialist consultation and treatments (e.g. delivery of thrombolysis). Telemedicine is a way that this can be facilitated, especially outside routine working hours. This study compared the timeliness of treatment and short-term patient outcomes when telemedicine or face-to-face assessment was used as part of the decision process of administering thrombolysis to patients affected by stroke. Method: Stroke data from SINAP and DASH databases between July 2011 and March 2013 was provided from six trusts in Lancashire and Cumbria which used telemedicine for the assessment of acute stroke, and eleven trusts within the North East of England which assessed patients face-to-face. Data was analysed from 220 stroke patients who received thrombolysis; this was restricted to those admitted out-of-hours as this was when telemedicine would normally be used. Results: The results showed that stroke patients assessed via telemedicine had a subsequent longer door-to needle time in comparison to those assessed via traditional face-to-face methods (95%CI: -32.43 to -11.15 minutes). Also, no significant differences were found between telemedicine and face-to-face assessments on patient outcomes such as length of stay in hospital (95%CI: -10.29 to 3.23 days), stay in stroke unit (95%CI: -10.42 to 3.01 days), rate of complications (OR 95%CI: 0.33 to 1.82) or discharge destination (OR 95%CI: 0.30 to 1.11). Conclusion: Patients assessed by telemedicine have a longer door-toneedle time than those assessed face-to-face. However, whether assessment was via telemedicine or face-to-face does not appear to affect short-term patient outcomes.

Background: Web-based interventions to support people to manage long-term health conditions are available and effective but rarely used in clinical services. The aim of this study is to identify critical factors impacting on the implementation of an online supported self-management intervention for relatives of people with recent onset psychosis or bipolar disorder into routine clinical care and to use this information to inform an implementation plan to facilitate widespread use and inform wider implementation of digital health interventions. Methods: A multiple case study design within six early intervention in psychosis (EIP) services in England, will be used to test and refine theory-driven hypotheses about factors impacting on implementation of the Relatives’ Education And Coping Toolkit (REACT). Qualitative data including behavioural observation, document analysis, and in-depth interviews collected in the first two EIP services (wave 1) and analysed using framework analysis, combined with quantitative data describing levels of use by staff and relatives and impact on relatives’ distress and wellbeing, will be used to identify factors impacting on implementation. Consultation via stakeholder workshops with staff and relatives and co-facilitated by relatives in the research team will inform development of an implementation plan to address these factors, which will be evaluated and refined in the four subsequent EIP services in waves 2 and 3. Transferability of the implementation plan to non-participating services will be explored. Discussion: Observation of implementation in a real world clinical setting, across carefully sampled services, in real time provides a unique opportunity to understand factors impacting on implementation likely to be generalizable to other web-based interventions, as well as informing further development of implementation theories. However, there are inherent challenges in investigating implementation without influencing the process un

• Background Current multimodal approaches for the management of non-specific patellofemoral pain are not optimal, however, targeted intervention for subgroups could improve patient outcomes. This study explores whether subgrouping of non-specific patellofemoral pain patients, using a series of low cost simple clinical tests, is possible. • Method The exclusivity and clinical importance of potential subgroups was assessed by applying à priori test thresholds (1 SD) from seven clinical tests in a sample of adult patients with non-specific patellofemoral pain. Hierarchical clustering and latent profile analysis, were used to gain additional insights into subgroups using data from the same clinical tests. • Results One hundred and thirty participants were recruited, 127 had complete data: 84 (66%) female, mean age 26 years (SD 5.7) and mean BMI 25.4 (SD 5.83), median (IQR) time between onset of pain and assessment was 24 (7-60) months. Potential subgroups defined by the à priori test thresholds were not mutually exclusive and patients frequently fell into multiple subgroups. Using hierarchical clustering and latent profile analysis three subgroups were identified using 6 of the 7 clinical tests. These subgroups were given the following nomenclature: (i) ‘strong’, (ii) ‘weak and tighter’, and (iii) ‘weak and pronated foot’. • Conclusions We conclude that three subgroups of patellofemoral patients may exist based on the results of six clinical tests which are feasible to perform in routine clinical practice. Further research is needed to validate these findings in other datasets and, if supported by external validation, to see if targeted interventions for these subgroups improve patient outcomes.