Search

Objectives Mindfulness-based programs (MBPs) such as the ‘Soles of the Feet’ (SoF) meditation have been shown to be effective for reducing aggressive behavior in people with intellectual disabilities (ID). Research on SoF has shown promising results in the USA but there is an absence of evidence for the approach in the United Kingdom (UK). The aim of this research was to adapt SoF for the UK and to assess the feasibility and cost of implementing the SoF intervention in a UK healthcare setting (UK SoF). Methods The UK SoF intervention consisted of a manualized protocol delivered over a six-week period by National Health Service staff to people with ID and their carers. This was a single-arm study with three measurement time points (baseline and 2- and 6-month follow-ups). Results The UK SoF intervention was shown to be feasible, with recruitment, retention, and adherence figures exceeding the minimum cut-off of 50%. Costs were £2426 per participant, or £2766 when including set-up costs such as therapist training. Although not a primary aim, data suggest that at 6-month follow-up, there was a reduction in scores for anger and aggressive behavior, and depression and anxiety showed improvement. In addition, people with ID were able to self-report on their health-related quality of life. Conclusions This study has indicated areas where the protocol could be further improved, and it is recommended that the research should move to a pilot trial before the development of a full randomized control trial.

Background The effective management of agitation and other neuropsychiatric and behavioural symptoms in people with dementia is a major challenge, particularly in care home settings, where dementia severity is higher and there is limited training and support for care staff. There is evidence for the value of staff training and the use of psychosocial approaches; however, no intervention currently exists that combines these elements into an intervention that is fit for purpose and effective in these settings based on evidence from a randomised controlled trial. Objective The objective was to develop and evaluate a complex intervention to improve well-being, reduce antipsychotic use and improve quality of life in people with dementia in care homes through person-centred care, management of agitation and non-drug approaches. Design This was a 5-year programme that consisted of six work packages. Work package 1 consisted of two systematic reviews of personalised psychosocial interventions for behavioural and psychological symptoms for people with dementia in care homes. Work package 2 consisted of a metasynthesis of studies examining implementation of psychosocial interventions, in addition to developing a draft Well-being and Health for people with Dementia (WHELD) programme. Work package 3 consisted of a factorial study of elements of the draft WHELD programme in 16 care homes. Work package 4 involved optimisation of the WHELD programme based on work package 3 data. Work package 5 involved a multicentre randomised controlled trial in 69 care homes, which evaluated the impact of the optimised WHELD programme on quality of life, agitation and overall neuropsychiatric symptoms in people with dementia. Work package 6 focused on dissemination of the programme. Setting This programme was carried out in care homes in the UK. Participants Participants of this programme were people with dementia living in care homes, and the health and care professionals providing treatment and care in these settings. Results Work package 1: reviews identified randomised controlled trials and qualitative evidence supporting the use of psychosocial approaches to manage behavioural symptoms, but highlighted a concerning lack of evidence-based training manuals in current use. Work package 2: the meta-analysis identified key issues in promoting the use of interventions in care homes. The WHELD programme was developed through adaptation of published approaches. Work package 3: the factorial trial showed that antipsychotic review alone significantly reduced antipsychotic use by 50% (odds ratio 0.17, 95% confidence interval 0.05 to 0.60). Antipsychotic review plus social interaction significantly reduced mortality (odds ratio 0.36, 95% confidence interval 0.23 to 0.57), but this group showed significantly worse outcomes in behavioural and psychological symptoms of dementia than the group receiving neither antipsychotic review nor social interaction (mean difference 7.37 symptoms, 95% confidence interval 1.53 to 13.22 symptoms). This detrimental impact was reduced when combined with social interaction (mean difference –0.44 points, 95% confidence interval –4.39 to 3.52 points), but with no significant benefits for agitation. The exercise intervention significantly improved neuropsychiatric symptoms (mean difference –3.58 symptoms, 95% confidence interval –7.08 to –0.09 symptoms) but not depression (mean difference –1.21 points, 95% confidence interval –4.35 to 1.93 points). Qualitative work with care staff provided additional insights into the acceptability and feasibility of the intervention. Work package 4: optimisation of the WHELD programme led to a final version that combined person-centred care training with social interaction and pleasant activities. The intervention was adapted for delivery through a ‘champion’ model. Work package 5: a large-scale, multicentre randomised controlled trial in 69 care homes showed significant benefit to quality of life, agitation and overall neuropsychiatric symptoms, at reduced overall cost compared with treatment as usual. The intervention conferred a statistically significant improvement in quality of life (Dementia Quality of Life Scale – Proxy z-score of 2.82, mean difference 2.54, standard error of measurement 0.88, 95% confidence interval 0.81 to 4.28, Cohen’s d effect size of 0.24; p = 0.0042). There were also statistically significant benefits in agitation (Cohen-Mansfield Agitation Inventory z-score of 2.68, mean difference –4.27, standard error of measurement 1.59, 95% confidence interval –7.39 to –1.15, Cohen’s d effect size of 0.23; p = 0.0076) and overall neuropsychiatric symptoms (Neuropsychiatric Inventory – Nursing Home version z-score of 3.52, mean difference –4.55, standard error of measurement 1.28, 95% confidence interval –7.07 to –2.02, Cohen’s d of 0.30; p British Medical Journal e-learning module, an updated national best practice guideline and a portfolio of lay and care home outreach activities. Limitations Residents with dementia were not involved in the qualitative work. Conclusions The WHELD programme is effective in improving quality of life and reducing both agitation and overall neuropsychiatric symptoms in people with dementia in care homes. It provides a structured training and support intervention for care staff, with lower overall costs for resident care than treatment as usual. Future work It will be important to consider the long-term sustainability of the WHELD programme and cost-effective means of long-term implementation. Trial registration Current Controlled Trials ISRCTN40313497 and ISRCTN62237498. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 6. See the NIHR Journals Library website for further project information.

Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries.To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods.Home-based care without 24/7 paid care provision, in three UK sites.Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency.Intervention-group carers received training by local nurses using a manualised training package.Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of 40% retention was, therefore, considered not met. A total of 12 carers (intervention,The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.Current Controlled Trials ISRCTN11211024.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inMost people in the UK would prefer to die at home, but only half of them achieve this. This usually depends on having able and willing lay carers (family or friends) to help look after them. Once swallowing is not possible, medicine is given continually under the skin (syringe driver). If common problems such as pain, vomiting or agitation break through, health-care professionals attend to give extra doses. The wait for a health-care professional to arrive can be distressing. In the UK, it is legal (but not routine) for lay carers to give needle-free subcutaneous injections themselves. We reworked an Australian carer education package for UK use. The best way to find out if this would work well is to do a randomised controlled trial. This is a test in which, at random, half of the people taking part receive ‘usual care’ and the other half receive the ‘new care’ or intervention. A pilot randomised controlled trial (a ‘test’ trial to see if a larger one is worth doing) was carried out to determine if lay carer injections were possible in the UK. We approached 90 dyads (a dying person and a key carer) and, of these, 40 were willing to take part and 22 completed the follow-up visit, so we could analyse their data. Of these 22 dyads, 16 were in the intervention group (lay carer injects) and six were in the control group (usual care). All carers were asked to keep a diary. Carers and health-care professionals were interviewed (qualitative study) and carer preferences were assessed. This new practice was safe, acceptable and welcomed. Carer confidence increased rapidly, symptom control was quicker and the interviews backed up these findings. Recruitment was low owing to overstretched health-care professionals. Only certain families were picked. Dyads in the usual-care group often wished they were in the intervention group. Carers found it difficult to complete some of the questionnaires that were used to measure the effect of the intervention. Therefore, uncertainty remains as to whether or not a full trial should proceed. Because the practice is already legal, some areas in the UK are already undertaking it. We plan to study what makes this practice possible or less possible to achieve.

Objectives The Rare Dementia Support (RDS) Impact study will be the first major study of the value of multicomponent support groups for people living with or supporting someone with a rare form of dementia. The multicentre study aims to evaluate the impact of multicomponent support offered and delivered to people living with a rare form of dementia, comprising the following five work packages (WPs): (a) longitudinal cohort interviews, (b) theoretical development, (c) developing measures, (d) novel interventions, and (e) economic analysis. Methods This is a mixed-methods design, including a longitudinal cohort study (quantitative and qualitative) and a feasibility randomised control trial (RCT). A cohort of more than 1000 individuals will be invited to participate. The primary and secondary outcomes will be in part determined through a co-design nominal groups technique prestudy involving caregivers to people living with a diagnosis of a rare dementia. Quantitative analyses of differences and predictors will be based on prespecified hypotheses. A variety of quantitative (eg, analysis of variance [ANOVA] and multiple linear regression techniques), qualitative (eg, thematic analysis [TA]), and innovative analytical methods will also be developed and applied by involving the arts as a research method. Results The UCL Research Ethics Committee have approved this study. Data collection commenced in January 2020. Conclusions The study will capture information through a combination of longitudinal interviews, questionnaires and scales, and novel creative data collection methods. The notion of "impact" in the context of support for rare dementias will involve theoretical development, novel measures and methods of support interventions, and health economic analyses.

Background People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness. Methods We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13–25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants’ homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective. Discussion We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia. Trial registration ISRCTN, ISRCTN15320670. Registered on 4 September 2018.

Background and study aims The English National Bowel Scope Screening Programme (BSSP) invites 55-year-olds for a one-off, unsedated flexible sigmoidoscopy (FSIG). Data from BSSP participant-reported experience studies shows 1 in 3 participants report moderate or severe discomfort. Water-assisted colonoscopy (WAS) may improve participants’ comfort. The primary objective of this study is to ascertain if post-procedural participant-assessed pain is reduced in WAS compared with carbon dioxide (CO2) insufflation, in invitees undergoing FSIG in BSSP. Patients and methods This is a multicenter, prospective, randomized, two-arm, single-blinded trial designed to evaluate the performance of WAS versus CO2 insufflation in BSSP. Participants will be randomized to either CO2 or WAS and will be asked to rate pain post-procedure. Key procedure-related data will be analyzed, including adenoma detection rates (ADR) and degree of sigmoid looping. A cost-effectiveness analysis of WAS versus CO2 and a discrete choice experiment exploring preferences of participants for attributes of sigmoidoscopy will also be performed. Discussion This is the first trial in the United Kingdom (UK) to investigate the effects of WAS in a screening setting. If the trial shows WAS either reduces pain or increases ADR, this may result in a practice change to implement WAS in screening and non-screening endoscopic practice directly impacting on 256,000 people a year who will undergo BSSP FSIG by 2020.Trial funding came from National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) supported by the NIHR Clinical Research Network. The trial is actively recruiting. ID: 35866 ISRCTN: 81466870

Background Compared to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing COVID-19 pandemic and its major impact on cancer referrals. The ThinkCancer! workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! intervention for a future definitive randomised controlled trial. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect primary care intervals (PCI), 2-week wait (2WW) referral rates, conversion rates and detection rates at baseline and 6 months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial. Trial registration ClinicalTrials.gov NCT04823559.

Funder: Public Health Research Programme; doi: http://dx.doi.org/10.13039/501100001921; Grant(s): NIHR-PHR: 16/122/35, Background: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children’s well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0–10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far. Methods/design: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3–18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention. Discussion: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities. Trial registration: Prospectively registered Randomised Controlled Trial ISRCTN15194500.

Background Evidence for interventions promoting oral health amongst care home residents is weak. The National Institute for Health and Care Excellence (NICE) guideline NG48 aims to maintain and improve the oral health of care home residents. A co-design process that worked with residents and care home staff to understand how the NG48 guideline could be best implemented in practice has been undertaken to refine a complex intervention. The aim of this study is to assess the feasibility of the intervention to inform a future larger scale definitive trial. Methods This is a protocol for a pragmatic cluster randomised controlled trial with a 12-month follow-up that will be undertaken in 12 care homes across two sites (six in London, six in Northern Ireland). Care homes randomised to the intervention arm (n = 6) will receive the complex intervention based on the NG48 guideline, whilst care homes randomised to the control arm (n = 6) will continue with routine practice. The intervention will include a training package for care home staff to promote knowledge and skills in oral health promotion, the use of the Oral Health Assessment Tool on residents by trained care home staff, and a ‘support worker assisted’ daily tooth-brushing regime with toothpaste containing 1500 ppm fluoride. An average of ten residents, aged 65 years or over who have at least one natural tooth, will be recruited in each care home resulting in a recruited sample of 120 participants. Assessments will be undertaken at baseline, 6 months and 12 months, and will include a dental examination and questionnaires on general health and oral health administered by a research assistant. A parallel process evaluation involving semi-structured interviews will be undertaken to explore how the intervention could be embedded in standard practice. Rates of recruitment and retention, and intervention fidelity will also be recorded. A cost-consequence model will determine the relevance of different outcome measures in the decision-making context. Discussion The study will provide valuable information for trialists, policymakers, clinicians and care home staff on the feasibility and associated costs of oral health promotion in UK care homes. Trial registration ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613.

Mindfulness-based programs have been delivered to people with intellectual disabilities (ID) and aggressive behaviour with some success. The current study is part of a wider feasibility study, which aimed to test the adaptation of the Soles of the Feet (SoF) meditation practice to a six-session, one-to-one intervention delivered within the UK National Health Service. It was designed for adults with ID to help reduce their aggressive behaviour. Eighteen stakeholders were interviewed from three groups: (1) people with ID who took part in the intervention, (2) their supporters, and (3) therapists who delivered the intervention. Thematic analysis was used to analyse the data. The intervention had high acceptability among participants, although they reported mixed outcomes, these outcomes aligned closely with reports on effectiveness from supporters and therapists. Some people with ID and their supporters reported positive changes, such as reduced aggression, increased sociability, and higher quality of life. Some participants reported no change. Four participants and their supporters reported clear benefits from the SoF intervention. For the three that did not report benefits, this appeared to be related to whether the person with ID understood the intervention and/or were motivated to reduce their aggressive behaviour. There was also evidence of supporters needing more direct instruction on how to facilitate the SoF intervention with the person they care for. Suggestions for future research are made, and clinical implications explored.

BackgroundCognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning.ObjectivesTo determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer’s disease or vascular or mixed dementia, and their carers.DesignThis multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation.SettingCommunity.ParticipantsParticipants had anInternational Classification of Diseases, Tenth Edition, diagnosis of Alzheimer’s disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm.InterventionCognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants’ homes. The therapists were nine occupational therapists and one nurse.Outcome measuresThe primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants’ group allocation.ResultsA total of 475 participants were randomised (CR arm,n = 239; TAU arm,n = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm,n = 208, TAU arm,n = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen’sd = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen’sd = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen’sd = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen’sd = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost–utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.LimitationsPossible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia.ConclusionsCognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions.Future workNext steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia.Trial registrationCurrent Controlled Trials ISRCTN21027481.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 10. See the NIHR Journals Library website for further project information.

ObjectiveTo determine the feasibility of a definitive trial in primary care of electronic clinical decision support (eCDS) for possible oesophago-gastric (O-G) cancer.Design and settingFeasibility study in 42 general practices in two regions of England, cluster randomised controlled trial design without blinding, nested qualitative and health economic evaluation.ParticipantsPatients aged 55 years or older, presenting to their general practitioner (GP) with symptoms associated with O-G cancer. 530 patients (mean age 68 years, 58% female) participated.InterventionPractices randomised 1:1 to usual care (control) or to receive a previously piloted eCDS tool for suspected cancer (intervention), for use at the discretion of the GPs, supported by a theory-based implementation package and ongoing support. We conducted semistructured interviews with GPs in intervention practices. Recruitment lasted 22 months.OutcomesPatient participation rate, use of eCDS, referrals and route to diagnosis, O-G cancer diagnoses; acceptability to GPs; cost-effectiveness. Participants followed up 6 months after index encounter.ResultsFrom control and intervention practices, we screened 3841 and 1303 patients, respectively; 1189 and 434 were eligible, 392 and 138 consented to participate. Ten patients (1.9%) had O-G cancer. eCDS was used eight times in total by five unique users. GPs experienced interoperability problems between the eCDS tool and their clinical system and also found it did not fit with their workflow. Unexpected restrictions on software installation caused major problems with implementation.ConclusionsThe conduct of this study was hampered by technical limitations not evident during an earlier pilot of the eCDS tool, and by regulatory controls on software installation introduced by primary care trusts early in the study. This eCDS tool needed to integrate better with clinical workflow; even then, its use for suspected cancer may be infrequent. Any definitive trial of eCDS for cancer diagnosis should only proceed after addressing these constraints.Trial registration numberISRCTN125595588.

Background Many dental ‘check-ups’ in the NHS result in no further treatment. The patient is examined by a dentist and returned to the recall list for a further check-up, commonly in 6 or 12 months’ time. As the oral health of regular dental attenders continues to improve, it is likely that an increasing number of these patients will be low risk and will require only a simple check-up in the future, with no further treatment. This care could be delivered by dental therapists. In 2013, the body responsible for regulating the dental profession, the General Dental Council, ruled that dental therapists could see patients directly and undertake check-ups and routine dental treatments (e.g. fillings). Using dental therapists to undertake check-ups on low-risk patients could help free resources to meet the future challenges for NHS dentistry. Objectives The objectives were to determine the most appropriate design for a definitive study, the most appropriate primary outcome measure and recruitment and retention rates, and the non-inferiority margin. We also undertook a realist-informed process evaluation and rehearsed the health economic data collection tool and analysis. Design A pilot randomised controlled trial over a 15-month period, with a realist-informed process evaluation. In parallel, we rehearsed the health economic evaluation and explored patients’ preferences to inform a preference elicitation exercise for a definitive study. Setting The setting was NHS dental practices in North West England. Participants A total of 217 low-risk patients in eight high-street dental practices participated. Interventions The current practice of using dentists to provide NHS dental check-ups (treatment as usual; the control arm) was compared with using dental therapists to provide NHS dental check-ups (the intervention arm). Main outcome measure The main outcome measure was difference in the proportion of sites with bleeding on probing among low-risk patients. We also recorded the number of ‘cross-over’ referrals between dentists and dental therapists. Results No differences were found in the health status of patients over the 15 months of the pilot trial, suggesting that non-inferiority is the most appropriate design. However, bleeding on probing suffered from ‘floor effects’ among low-risk patients, and recruitment rates were moderately low (39.7%), which suggests that an experimental design might not be the most appropriate. The theory areas that emerged from the realist-informed process evaluation were contractual, regulatory, institutional logistics, patients’ experience and logistics. The economic evaluation was rehearsed and estimates of cost-effectiveness made; potential attributes and levels that can form the basis of preference elicitation work in a definitive study were determined. Limitations The pilot was conducted over a 15-month period only, and bleeding on probing appeared to have floor effects. The number of participating dental practices was a limitation and the recruitment rate was moderate. Conclusions Non-inferiority, floor effects and moderate recruitment rates suggest that a randomised controlled trial might not be the best evaluative design for a definitive study in this population. The process evaluation identified multiple barriers to the use of dental therapists in ‘high-street’ practices and added real value. Future work Quasi-experimental designs may offer more promise for a definitive study alongside further realist evaluation. Trial registration Current Controlled Trials ISRCTN70032696. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

Introduction Bowel cancer is the UK’s 2nd most common cause of cancer death. To reduce this risk, the NHS Bowel Cancer Screening Programme invites 55-year olds for sigmoidoscopy (Bowel Scope Screening-BSS). A national patient survey showed much higher procedural pain than anticipated, potentially impacting on compliance and screening effectiveness. Studies indicate that a new technique using water-assisted scope insertion (WAS) may minimise bowel distension, hence reduce pain and also increase polyp detection. We aimed to assess the effect of WAS on procedural pain and adenomatous polyp detection, compared to CO2 assisted scope insertion. We aimed to perform a cost-effectiveness analysis of WAS, a discrete choice experiment (DCE) to ascertain patient preferences, and to survey trial endoscopists’ technique preference after the trial. Methods We performed an RCT of 1123 people undergoing BSS, randomised 1:1 to WAS (for which the endoscopists received training) or CO2. The primary outcome was patient-reported moderate/severe pain. The key secondary outcome was adenoma detection rate (ADR). Results We found no difference in patient-reported moderate/severe pain between WAS and CO2 (p=0.47;logistic regression; predictive marginal estimates 14% in WAS and 15% in CO2). Moderate/severe pain was significantly lower in both arms than in the previous national survey (p ADR was significantly higher in the CO2 arm (p=0.03, logistic regression; odds ratio 1.45 (95% CI; 1.03, 2.04); predictive marginal estimates 11% in WAS and 15% in CO2). However, it remained above the minimum national performance standard in both arms and there was no statistical difference in mean number of adenomas nor overall polyp detection rate. Cost-consequence analysis revealed a negligible difference between the two techniques. The DCE revealed that patients care more about the risk of missing an abnormality and risk of a serious complication than the level of pain experienced. Exit survey of trial endoscopists revealed 10 preferred WAS, one preferred CO2 and 4 were neutral. Conclusions In the context of enema-prepared unsedated screening sigmoidoscopies performed by screening-accredited endoscopists, no difference in patient-reported pain was seen when using either a CO2 or WAS intubation technique. There is no need for screening sigmoidoscopists to switch to a WAS technique. Caution should be given to monitoring ADR if WAS is used in enema-prepared sigmoidoscopies. Research funded by NIHR RfPB. ISRCTN: 81466870

IntroductionThe public health measures imposed to contain Covid-19 during the first UK lockdown resulted in significant changes in the provision of community support and care for people with dementia. People with low prevalence and young-onset dementias often experience non-memory, behavioural or neuropsychiatric symptoms that require specialised support.ObjectiveWe explored the impact of the first Covid-19 lockdown on people living with low prevalence and young-onset dementia and their carers in the UK.MethodAn online survey, including eleven questions about the impact of the lockdown on both the person with dementia and their family caregivers was conducted. Participants were people living with dementia and caregivers who are members of the UK national-reach organisation Rare Dementia Support.Results184 carers and 24 people with dementia completed the survey. People with dementia experienced worsening of cognitive symptoms (70%), ability to do things (62%) and well-being (57%) according to their carers. Carers also reported a reduction in the support received for caring (55%). 93% of carers of people living in care homes reported a reduction in their ability to provide care. 26% of carers reported changes in the medication of the person with dementia during the lockdown. 74% of people with dementia reported decreased ability to connect with people socially.ConclusionsPeople with dementia experienced a worsening of dementia symptoms, removal of support and increased difficulty to connect with other people socially during the 1st wave of Covid-19. Carers encountered barriers to both receiving and providing support and a decline in their own mental health and well-being.Key points70 % of carers reported cognitive symptoms getting worse during the lockdown (e.g., the person with dementia being more disoriented and finding it more difficult to communicate).26 % of carers reported a change (initiation or increase) in medication in the person with dementia during the lockdown.79 % carers reported their own physical or mental health getting worse due to the lockdown. This increased to 93% when considering responses only from family carers of people living in care homes.93 % of family carers of people living in care homes found it harder to continue providing care and support for their relative due to Covid-19.

BackgroundRelatively poor UK cancer outcomes are blamed upon late diagnosis. Despite most cancer patients presenting to their GP with symptoms, diagnostic delay remains a common theme, with many clinical and non-clinical factors responsible. Early diagnosis is key to improving outcomes and survival. This paper reports the multi-method process to design a complex intervention to improve the timely diagnosis of symptomatic cancer.MethodsA review of reviews, survey, discrete choice experiment, qualitative interviews and focus groups, all informed a realist evidence synthesis. This in turn informed the design of a complex intervention, guided by the Behaviour Change Wheel framework using a multi-step process.ResultsKey themes from the realist evidence synthesis included effective safety netting at practitioner and practice system level, increased vigilance and lowering referral thresholds. Qualitative findings explored the tensions, barriers and facilitators affecting suspected cancer referral. The Think Cancer! intervention is an educational and quality improvement workshop directed at the whole primary care team. Bespoke cancer safety netting plans and appointment of cancer champions are key components.ConclusionsThink Cancer! is a novel primary care early cancer diagnosis intervention, requiring evaluation through a cluster randomised control trial.

ObjectivesThe English Bowel Cancer Screening Programme invites 55 year olds for a sigmoidoscopy (Bowel Scope Screening (BSS)), aiming to resect premalignant polyps, thus reducing cancer incidence. A national patient survey indicated higher procedural pain than anticipated, potentially impacting on screening compliance and effectiveness. We aimed to assess whether water-assisted sigmoidoscopy (WAS), as opposed to standard CO2 technique, improved procedural pain and detection of adenomatous polyps.DesignThe WASh (Water-Assisted Sigmoidoscopy) trial was a multicentre, single-blind, randomised control trial for people undergoing BSS. Participants were randomised to either receive WAS or CO2 from five sites across England. The primary outcome measure was patient-reported moderate/severe pain, as assessed by patients on a standard Likert scale post procedure prior to discharge. The key secondary outcome was adenoma detection rate (ADR). The costs of each technique were also measured.Results1123 participants (50% women, mean age 55) were randomised (561 WAS, 562 CO2). We found no difference in patient-reported moderate/severe pain between WAS and CO2 (14% in WAS, 15% in CO2; p=0.47). ADR was 15% in the CO2 arm and 11% in the WAS arm (p=0.03); however, it remained above the minimum national performance standard in both arms. There was no statistical difference in mean number of adenomas nor overall polyp detection rate. There was negligible cost difference between the two techniques.ConclusionIn the context of enema-prepared unsedated screening sigmoidoscopies performed by screening-accredited endoscopists, no difference in patient-reported pain was seen when using either a CO2 or WAS intubation technique.Trial registration numberISRCTN81466870.

BackgroundWe tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions.MethodsWe conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register.Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary.ResultsBetween September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention.ConclusionWe conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial.Trial registrationClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016),ISRCTN: 10550694(date assigned 31st August 2016).

BackgroundAlthough it is widely recognised that adopting a person-centred approach is beneficial in the care of people living with dementia, a gap remains between the rhetoric and the reality of quality care. Some widely adopted care practices can result in the personhood of this group being threatened and their human rights being undermined.ObjectivesTo evaluate the impact of applying a human rights based approach in dementia inpatient wards and care homes on the quality of care delivered and the well-being of the person living with dementia.DesignA cluster randomised design was employed to compare the impact of implementing a human rights based approach intervention (i.e. training, applying the ‘Getting It Right’ assessment tool and receiving booster sessions) at 10 intervention sites with 10 control sites.SettingEight NHS dementia inpatient wards and 12 care homes in the north-west of England.ParticipantsPeople living with dementia who were residing on dementia inpatient wards or in care homes, and staff working at these sites. The aim was to recruit 280 people living with dementia.InterventionsA sample of staff (an average of 8.9 per site) at each of the sites was trained in a human rights based approach to care, including the application of the ‘Getting It Right’ assessment tool. The tool was then introduced at the site and monthly booster sessions were delivered.Main outcome measuresThe primary outcome measure used in the research was the Quality of Life in Alzheimer’s Disease scale to assess the subjective well-being of the person with dementia. Secondary outcome measures included measures of the quality of care provided (dementia care mapping) and direct measures of the effectiveness of the training in increasing knowledge of and attitudes towards human rights. The study also included an economic evaluation utilising the EuroQol-5 Dimensions, three-level version, and the Adult Social Care Outcomes Toolkit measure.ResultsThe study recruited 439 people living with dementia: 213 to the intervention arm and 226 to the control arm. Primary outcome data were analysed using a linear mixed model. There were no significant differences found in the reported quality of life of residents between the control and intervention groups after the intervention [F(1,16.51) = 3.63;p = 0.074]. The mean difference between the groups was 1.48 (95% confidence interval –7.86 to 10.82).ConclusionsDespite the fact that the training increased staff knowledge of and positive attitudes towards human rights, and although there were some changes in staff decision-making strategies in clinical situations, there was no change in the quality of care provided or in the reported well-being of people living with dementia in these settings. This led to questions about the efficacy of training in bringing about cultural change and improving care practices.LimitationsThere was limited uptake of the training and booster sessions that were integral to the intervention.Future workFuture work could usefully focus on understanding the difficulty in translating change in attitude and knowledge into behaviour.Trial registrationCurrent Controlled Trials ISRCTN94553028.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 6, No. 13. See the NIHR Journals Library website for further project information.

People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses. We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis. In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial. ClinicalTrials.gov: NCT02874300 ; ISRCTN 10550694 .

ObjectiveLow adenoma detection rates (ADR) are linked to increased postcolonoscopy colorectal cancer rates and reduced cancer survival. Devices to enhance mucosal visualisation such as Endocuff Vision (EV) may improve ADR. This multicentre randomised controlled trial compared ADR between EV-assisted colonoscopy (EAC) and standard colonoscopy (SC).DesignPatients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme were recruited from seven hospitals. ADR, mean adenomas per procedure, size and location of adenomas, sessile serrated polyps, EV removal rate, caecal intubation rate, procedural time, patient experience, effect of EV on workload and adverse events were measured.Results1772 patients (57% male, mean age 62 years) were recruited over 16 months with 45% recruited through screening. EAC increased ADR globally from 36.2% to 40.9% (P=0.02). The increase was driven by a 10.8% increase in FOBt-positive screening patients (50.9% SC vs 61.7% EAC, PConclusionEV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection.Trial registration numberNCT02552017, Results; ISRCTN11821044, Results.

Purpose: To compare the performance of near vision activities using additional portable electronic vision enhancement systems (p-EVES), to using optical magnifiers alone, by individuals with visual impairment. Methods: A total of 100 experienced optical aid users were recruited from low vision clinics at Manchester Royal Eye Hospital, Manchester, UK, to a prospective two-arm cross-over randomised controlled trial. Reading, performance of near vision activities, and device usage were evaluated at baseline; and at the end of each study arm (Intervention A: existing optical aids plus p-EVES; Intervention B: optical aids only) which was after 2 and 4 months. Results: A total of 82 participants completed the study. Overall, maximum reading speed for high contrast sentences was not statistically significantly different for optical aids and p-EVES, although the critical print size and threshold print size which could be accessed with p-EVES were statistically significantly smaller (p

OBJECTIVE: There is evidence that Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy are effective in mild to moderate dementia. There is, however, little evidence available for its implementation in practice and the impact of outreach support on the sustainability of the programme. METHODS: Two hundred and forty-one staff members were randomised from 63 dementia care settings between outreach support including an online forum, email, and telephone support, compared to usual Cognitive Stimulation Therapy control group. The primary outcome was average number of attendees to the Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy programmes. RESULTS: There was no difference in average number of attendees between the intervention and usual Cognitive Stimulation Therapy control groups for the Cognitive Stimulation Therapy (p = 0.82) or the maintenance Cognitive Stimulation Therapy programme (p = 0.97). CONCLUSIONS: Outreach support does not affect the average number of people with dementia attending the Cognitive Stimulation Therapy or maintenance Cognitive Stimulation Therapy programme. Irrespective of outreach support, the programmes remain widely implemented and yield perceived benefits for people with dementia.

Background The sensitivity of endoscopic ultrasound (EUS) in staging gastro-oesophageal cancers (GOCs) has been widely studied. However, the economic evidence of EUS staging in the management of patients with GOCs is scarce. This review aimed to examine all economic evidence (not limited to randomised controlled trials) of the use of EUS staging in the management of GOCs patients, and to offer a review of economic evidence on the costs, benefits (in terms of GOCs patients’ health-related quality of life), and economic implications of the use of EUS in staging GOCs patients. Methods The protocol was registered prospectively with PROSPERO (CRD42016043700; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42016043700). MEDLINE (ovid), EMBASE (ovid), The Cochrane Collaboration Register and Library (including the British National Health Service Economic Evaluation Database), CINAHL (EBSCOhost) and Web of Science (Core Collection) as well as reference lists were systematically searched for studies conducted between 1996 and 2018 (search update 28/04/2018). Two authors independently screened the identified articles, assessed study quality, and extracted data. Study characteristics of the included articles, including incremental cost-effectiveness ratios, when available, were summarised narratively. Results Of the 197 articles retrieved, six studies met the inclusion criteria: three economic studies and three economic modelling studies. Of the three economic studies, one was a cost-effectiveness analysis and two were cost analyses. Of the three economic modelling studies, one was a cost-effectiveness analysis and two were cost-minimisation analyses. Both of the cost-effectiveness analyses reported that use of EUS as an additional staging technique provided, on average, more QALYs (0.0019–0.1969 more QALYs) and saved costs (by £1969–£3364 per patient, 2017 price year) compared to staging strategy without EUS. Of the six studies, only one included GOCs participants and the other five included oesophageal cancer participants. Conclusions The data available suggest use of EUS as a complementary staging technique to other staging techniques for GOCs appears to be cost saving and offers greater QALYs. Nevertheless, future studies are necessary because the economic evidence around this EUS staging intervention for GOCs is far from robust. More health economic research and good quality data are needed to judge the economic benefits of EUS staging for GOCs. PROSPERO Registration Number CRD42016043700.

ObjectivesAdenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population.DesignBowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken.Results3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR.ConclusionEV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further.Trial registration numbersNCT03072472,ISRCTN30005319and CPMS ID 33224.

Introduction Adenoma detection rate (ADR) is the most important measure of mucosal visualisation at lower gastrointestinal endoscopy. Higher ADRs are associated with lower post-colonoscopy colorectal cancer (PCCRC) rates with a 3% reduction in PCCRCs with every 1% increase in ADR. In the English flexible sigmoidoscopy screening programme (Bowel scope) there is also significant variation in ADRs across screening centres. Large studies have demonstrated improved detection rates during screening procedures utilising Endocuff Vision™ (EV). The aim of this study is to determine the effect of Endocuff Vision on ADR in a flexible sigmoidoscopy bowel cancer screening population. Methods B-ADENOMA was a multicentre, randomised controlled trial involving 16 English Bowel scope screening centres, performed between February 2017 and April 2018. Patients attending for Bowel scope screening were randomised to Endocuff™-assisted Bowel scope (EAB) or Standard Bowel scope (SB). Adenoma Detection Rate (ADR) was compared between trial arms on an intention-to-treat basis. Secondary analyses compared Mean number of Adenomas per Procedure (MAP), Polyp Detection Rate (PDR), characteristics and location of polyps, procedural characteristics between arms and made comparisons with national Bowel scope data. Patient experience, procedure extent and complication rates were assessed for non-inferiority. Results 3222 patients were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between the two arms. ADR in the EAB arm was 13.3% and in the SB arm was 12.2% (p=0.353). Also, no statistically significant differences between arms were found in MAP, PDR, polyp morphology or location. Patient experience and complication rates were similar in both arms. The cuff exchange rate in the EAB arm was 4.2%. ADR in the SB arm was 3.1% higher than the national ADR (9.1%). Conclusions EV did not improve Bowel scope ADR when compared with standard Bowel scope. ADR in both arms was higher than the national ADR. This suggests that, where detection rates are already high, use of EV does not improve detection further. Reasons for the high ADR in the SB arm require further exploration but may include selection effects at centre level and contamination effects at endoscopist level.

Background: Whilst the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK. Methods: The paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life, wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval. Discussion: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial, and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37). Trial registration: ISRCTN, ISRCTN 11211024. Assigned 27 September 2016, http://www.isrctn.com/ISRCTN11211024. Keywords: End-of-life care, Care of the dying, Palliative care, Symptom control, Carer administration, Randomised pilot trial

PurposeRebuilding one’s life after stroke is a key priority persistently identified by patients yet professionally led interventions have little impact. This co-design study constructs and tests a novel peer-led coaching intervention to improve post-stroke leisure and general social participation. MethodsThis study followed the principles of co-design by actively engaging and harnessing the knowledge of stroke survivors in order to develop and test a peer-lead coaching intervention. Phase 1 assessed function, mood and involvement in leisure and social activities six months following stroke (n=79). Phase 2 involved semi-structured, in-depth interviews with 18 stroke survivors and 10 family carers to explore experiences related to social and leisure participation. Phase 3 tested the co-designed peer-led coaching intervention. Data collected also included co-design feedback sessions and a training workshop with selected peer coaches and in addition, interviews with stroke survivors and their peer coaches at two time-points: following the training programme (n=5) and delivery of the intervention (n=2). Results A peer coaching intervention was successfully co-designed and tested combining the use of lay knowledge sociocognitive and self-regulatory theories with principles of transformational leadership theory. Both peers and stroke survivors reported having benefited at a personal level. ConclusionsThis study reports on an innovative community-based and peer-led intervention and its results have generated new evidence on how stroke survivors engage with and respond to peer coaching support. It further provides a theoretical platform for designing and implementing peer interventions. Hence, these results have the potential to inform the development of future peer coaching intervention not only for stroke rehabilitation but also for a wide range of chronic conditions.

Background Crisis situations in dementia can lead to hospital admission or institutionalisation. Offering immediate interventions may help avoid admission, whilst stabilising measures can help prevent future crises. Objective Our objective was to identify the main causes of crisis and interventions to treat or prevent crisis in persons with dementia based on different stakeholder perspectives. Methods An online questionnaire was developed to identify the causes of crisis and appropriate interventions in a crisis. Participants included people with dementia, family carers and staff working in health and social care, including emergency and voluntary sectors, and academia. Results The results ranked the main causes of crisis, interventions that can prevent a crisis and interventions that can be useful in a crisis. Wandering, falls and infection were highly rated as risk factors for crises across all stakeholder groups. Consumers rated aggression as less important but severity of memory impairment as much more important than the other groups did. Education and support for family carers and home care staff were highly valued for preventing crises. Well-trained home care staff, communication equipment, emergency contacts and access to respite were highly valued for managing crises. Conclusions We identified triggers and interventions that different stakeholders see as important for crisis in dementia. Recognition of these may be critical to planning effective and accepted support and care for people with dementia.

Background Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. Methods A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months’ duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. Results The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. Conclusions Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. Trial registration Current Controlled Trials, ISRCTN14569274. Registered on 15 December 2014.

Background Health economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants’ recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases. The aim was to test methods for obtaining these data and compare with those data collected using the CSRI, within a feasibility study of an enhanced rehabilitation intervention following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation: FEMuR). Methods Primary care activity including prescribing data was obtained from the Secure Anonymised Information Linkage (SAIL) Databank and secondary care activity (Emergency Department attendances, out-patient visits and in-patient days) directly from Betsi Cadwaladr University Health Board (BCUHB), North Wales, UK. These data were compared with patient responses from the CSRI using descriptive statistics and the intraclass correlation coefficient (ICC). Results It was possible to compare health service resource use data for 49 out of 61 participants in the FEMuR study. For emergency department (ED) attendances, records matched in 23 (47%) cases, 21 (43%) over-reported on electronic records compared with CSRI and five participants (10%) under-reported, with an overall ICC of 0.42. For out-patient episodes, records matched in only six cases, 28 participants over-reported on electronic records compared with CSRI and 15 (12%) under-reported, with an overall ICC of only 0.27. For in-patient days, records matched exactly in only five cases (10%), but if an error margin of 7 days was allowed, then agreement rose to 39 (66%) cases, and the overall ICC for all data was 0.88. It was only possible to compare prescribing data for 12 participants. For prescribing data, the SAIL data reported 117 out of 118 items (99%) and the CSRI only 89 (79%) items. Conclusions The use of routinely collected data has the potential to improve the efficiency of trials and other studies. Although the methodology to make the data available has been demonstrated, the data obtained was incomplete and the validity of using this method remains to be demonstrated. Trial registration Trial registration: ISRCTN22464643 Registered 21 July 2014. Electronic supplementary material The online version of this article (10.1186/s40814-018-0269-5) contains supplementary material, which is available to authorized users.

Objective The present parallel randomised control trial evaluated the feasibility of a nurse-led psycho-educational intervention aimed at improving the self-management of prostate cancer survivors. Methods We identified 305 eligible patients from a district general hospital, diagnosed 9-48 months previously, who completed radical treatment, or were monitored clinically (ineligible for treatment). Ninety-five patients were recruited by blinded selection and randomised to Intervention (N = 48) and Control (N = 47) groups. Participant allocation was revealed to patients and researchers after recruitment was completed. For 36 weeks, participants received augmented usual care (Control) or augmented usual care and additional nurse support (Intervention) provided in two community hospitals and a university clinic, or by telephone. Results Data from 91 participants (Intervention, N = 45; Control, N = 46) were analysed. All feasibility metrics met predefined targets: recruitment rate (31.15%; 95% CI: 25.95%-36.35%), attrition rate (9.47%; 95% CI: 3.58%-15.36%) and outcome measures completion rates (77%-92%). Forty-five patients received the intervention, with no adverse events. The Extended Prostate Cancer Index Composite can inform the minimum sample size for a future effectiveness trial. The net intervention cost was £317 per patient. Conclusions The results supported the feasibility and acceptability of the intervention, suggesting that it should be evaluated in a fully powered trial to assess its effectiveness and cost-effectiveness.

Objective This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment—Gynaecological. Methods The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals. We randomized participants to either usual hospital-based follow-up or specialist nurse–led telephone education, empowerment, and structured needs assessment follow-up. The primary outcomes assessed the feasibility of running a larger trial including patient eligibility, recruitment and retention rates, and outcome measure completion. Secondary outcomes were generic and health-related quality of life and a patient self-report health service use (Client Service Receipt Inventory) data collected at 3 time points (baseline, 3 months, and 6 months). Results Of the 58 women screened, 44 were eligible (76%) and 24 (55%) were recruited and randomized (12:12 to control and intervention, respectively). One participant was lost to follow-up. Recruited participants had a mean (SD) age of 60 (11.2) years and were approximately 5 months from their initial diagnosis (mean [SD], 159 [58] days). Seventeen (71%) of the participants had an endometrial cancer diagnosis. All outcome measure completion rates exceeded 96%. Although not a core feasibility objective, analyses of outcome measures indicated positive changes in quality of life and well-being within the Optimal Personalised Care After Treatment—Gynaecological group; exploratory cost consequence analysis indicated that the nurse-led intervention had a mean total service use cost of £27 per patient (bootstrapped 95% confidence interval, −£290 to £240) lower than did the standard care group. Conclusion Eligibility, recruitment, and retention rates as well as outcome measure completion showed that the trial is feasible.

This study aimed to assess and compare the psychometric performance of the EQ-5D in relation to other dementia-specific measures, the QoL-AD and DEMQoL, within a psychosocial intervention study. Two hundred and seventy-two people with dementia completed the EQ-5D, DEMQoL and QoL-AD. Convergent and discriminant validity of the measures were assessed, and inter-rater reliability was tested by comparing the self-reported and proxy scores of the measures. Internal consistency was tested using Cronbach’s alpha. Results satisfy convergent validity amongst the three outcome measures. EQ-5D, DEMQoL and QoL-AD total scores were shown to be significantly correlated with each other (p

BackgroundProximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking.ObjectivesTo develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation.DesignPhase I – realist review, survey and focus groups to develop the rehabilitation package. Phase II – parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study.SettingRecruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge.ParticipantsOlder adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area.InterventionsParticipants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients’ self-efficacy and increasing the amount and quality of patients’ practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions.Main outcome measuresThe primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale – International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers.ResultsSixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control,n = 32; intervention,n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen’sd = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen’sd = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen’sd = 0.31) and 1.3 (Cohen’sd = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported.ConclusionsTrial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure.Trial registrationCurrent Controlled Trials ISRCTN22464643.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information.

Purpose To determine the incremental cost-effectiveness of portable electronic vision enhancement system (p-EVES) devices compared with optical low vision aids (LVAs), for improving near vision visual function, quality of life and well-being of people with a visual impairment. Methods An AB/BA randomized crossover trial design was used. Eighty-two participants completed the study. Participants were current users of optical LVAs who had not tried a p-EVES device before and had a stable visual impairment. The trial intervention was the addition of a p-EVES device to the participant's existing optical LVA(s) for 2 months, and the control intervention was optical LVA use only, for 2 months. Cost-effectiveness and cost-utility analyses were conducted from a societal perspective. Results The mean cost of the p-EVES intervention was £448. Carer costs were £30 (4.46 hr) less for the p-EVES intervention compared with the LVA only control. The mean difference in total costs was £417. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £736 (95% CI £481 to £1525) for a 7% improvement in near vision visual function. Cost per quality-adjusted life year (QALY) ranged from £56 991 (lower 95% CI = £19 801) to £66 490 (lower 95% CI = £23 055). Sensitivity analysis varying the commercial price of the p-EVES device reduced ICERs by up to 75%, with cost per QALYs falling below £30 000. Conclusion Portable electronic vision enhancement system (p-EVES) devices are likely to be a cost-effective use of healthcare resources for improving near vision visual function, but this does not translate into cost-effective improvements in quality of life, capability or well-being.

OBJECTIVE: To examine the appropriateness and feasibility of cognitive rehabilitation for people with dementias associated with Parkinson's in a pilot randomised controlled study.\ud \ud METHODS: This was a single-blind pilot randomised controlled trial of goal-oriented cognitive rehabilitation for dementias associated with Parkinson's. After goal setting, participants were randomised to cognitive rehabilitation (n = 10), relaxation therapy (n = 10), or treatment-as-usual (n = 9). Primary outcomes were ratings of goal attainment and satisfaction with goal attainment. Secondary outcomes included quality of life, mood, cognition, health status, everyday functioning, and carers' ratings of goal attainment and their own quality of life and stress levels. Assessments were at 2 and 6 months following randomisation.\ud \ud RESULTS: At 2 months, cognitive rehabilitation was superior to treatment-as-usual and relaxation therapy for the primary outcomes of self-rated goal attainment (d = 1.63 and d = 1.82, respectively) and self-rated satisfaction with goal attainment (d = 2.04 and d = 1.84). At 6 months, cognitive rehabilitation remained superior to treatment-as-usual (d = 1.36) and relaxation therapy (d = 1.77) for self-rated goal attainment. Cognitive rehabilitation was superior to treatment as usual and/or relaxation therapy in a number of secondary outcomes at 2 months (mood, self-efficacy, social domain of quality of life, carers' ratings of participants' goal attainment) and at 6 months (delayed recall, health status, quality of life, carer ratings of participants' goal attainment). Carers receiving cognitive rehabilitation reported better quality of life, health status, and lower stress than those allocated to treatment-as-usual.\ud \ud CONCLUSIONS: Cognitive rehabilitation is feasible and potentially effective for dementias associated with Parkinson's disease.

Background There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson’s disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer’s disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson’s disease or dementia with Lewy bodies. Methods/design Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson’s disease, Parkinson’s disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke’s Cognitive Examination – III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient’s Parkinson’s disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients’ perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients’ objective cognitive performance (on tests of memory and executive function) and satisfaction with goal attainment, carers’ perception of patients’ goal attainment and patients’ and carers’ health status and psychosocial well-being, measured at the same time points. Cost-effectiveness will be examined to explore the design of a larger cost-effectiveness analysis alongside a full trial. Discussion This pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson’s disease dementia and dementia with Lewy bodies. The results of the study will inform the design of a fully powered randomised controlled trial. Trial registration ISRCTN16584442 DOI 10.1186/ISRCTN16584442 13 April 2015

This practical paper explains how to design an randomised controlled trial (RCT) for those who have little prior knowledge of the topic. It covers the basics of radomisation, statistical testing, sample size caluclations, bias and the role of Clinical Trial Units.

BackgroundDementia is a national priority and this research addresses the Prime Minister’s commitment to dementia research as demonstrated by his 2020 challenge and the new UK Dementia Research Institute. In the UK > 800,000 older people have dementia. It has a major impact on the lives of people with dementia themselves, on the lives of their family carers and on services, and costs the nation £26B per year. Pharmacological cures for dementias such as Alzheimer’s disease are not expected before 2025. If no cure can be found, the ageing demographic will result in 2 million people living with dementia by 2050. People with dementia lose much more than just their memory and their daily living skills; they can also lose their independence, their dignity and status, their confidence and morale, and their roles both within the family and beyond. They can be seen as a burden by society, by their families and even by themselves, and may feel unable to contribute to society. This programme of research aims to find useful interventions to improve the quality of life of people with dementia and their carers, and to better understand how people with dementia can be supported at home and avoid being admitted to hospital.Objectives(1) To develop and evaluate the maintenance cognitive stimulation therapy (MCST) for people with dementia; (2) to develop the Carer Supporter Programme (CSP), and to evaluate the CSP and Remembering Yesterday, Caring Today (RYCT) for people with dementia both separately and together in comparison with usual care; and (3) to develop a home treatment package (HTP) for dementia, to field test the HTP in practice and to conduct an exploratory trial.Methods(1) The MCST programme was developed for people with dementia based on evidence and qualitative work. A randomised controlled trial (RCT) [with a pilot study of MCST plus acetylcholinesterase inhibitors (AChEIs)] compared MCST with cognitive stimulation therapy (CST) only. The MCST implementation study conducted a trial of outreach compared with usual care, and assessed implementation in practice. (2) The CSP was developed based on existing evidence and the engagement of carers of people with dementia. The RCT (with internal pilot) compared the CSP and reminiscence (RYCT), both separately and in combination, with usual care. (3) A HTP for dementia, including the most promising interventions and components, was developed by systematically reviewing the literature and qualitative studies including consensus approaches. The HTP for dementia was evaluated in practice by conducting in-depth field testing.Results(1) Continuing MCST improved quality of life and improved cognition for those taking AChEIs. It was also cost-effective. The CST implementation studies indicated that many staff will run CST groups following a 1-day training course, but that outreach support helps staff go on to run maintenance groups and may also improve staff sense of competence in dementia care. The study of CST in practice found no change in cognition or quality of life at 8-month follow-up. (2) The CSP/RYCT study found no benefits for family carers but improved quality of life for people with dementia. RYCT appeared beneficial for the quality of life of people with dementia but at an excessively high cost. (3) Case management for people with dementia reduces admissions to long-term care and reduces behavioural problems. In terms of managing crises, staff suggested more costly interventions, carers liked education and support, and people with dementia wanted family support, home adaptations and technology. The easy-to-use home treatment manual was feasible in practice to help staff working in crisis teams to prevent hospital admissions for people with dementia.LimitationsGiven constraints on time and funding, we were unable to compete the exploratory trial of the HTP package or to conduct an economic evaluation.Future researchTo improve the care of people with dementia experiencing crises, a large-scale clinical trial of the home treatment manual is needed.ConclusionThere is an urgent need for effective psychosocial interventions for dementia. MCST improved quality of life and was cost-effective, with benefits to cognition for those on AChEIs. MCST was feasible in practice. Both CSP and RYCT improved the quality of life of people with dementia, but the overall costs may be too high. The HTP was useful in practice but requires evaluation in a full trial. Dementia care research may improve the lives of millions of people across the world.Trial registrationsCurrent Controlled Trials ISRCTN26286067 (MCST), ISRCTN28793457 (MCST implementation) and ISRCTN37956201 (CSP/RYCT).FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 5, No. 5. See the NIHR Journals Library website for further project information.

BackgroundBiological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention.ObjectivesTo test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica.DesignPragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot.SettingParticipants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics.ParticipantsAdults with persistent symptoms of sciatica of 1–6 months’ duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica.InterventionsAfter a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy.Main outcome measuresOutcomes were measured at the start, and after 6 weeks’ and 6 months’ follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland–Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects.Sample sizeTo detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailedt-test and 80% retention rate, 332 participants would have needed to be recruited.Analysis planThe primary effectiveness analysis would have been linear mixed models for repeated measures to measure the effects of time and group allocation. An internal pilot study would have involved the first 50 participants recruited across all centres. The primary economic analysis would have been a cost–utility analysis.ResultsThe internal pilot study was discontinued as a result of low recruitment after eight participants were recruited from two out of six sites. One site withdrew from the study before recruitment started, one site did not complete contract negotiations and two sites signed contracts shortly before trial closure. In the two sites that did recruit participants, recruitment was slow. This was partly because of operational issues, but also because of a low rate of uptake from potential participants.LimitationsAlthough large numbers of invitations were sent to potential participants, identified by retrospective searches of general practitioner (GP) records, there was a low rate of uptake. Two sites planned to recruit participants during GP consultations but opened too late to recruit any participants.ConclusionThe main failure was attributable to problems with contracts. Because of this we were not able to complete the internal pilot or to test all of the different methods for primary care recruitment we had planned. A trial of biological therapy in patients with sciatica still needs to be done, but would require a clearer contracting process, qualitative research to ensure that patients would be willing to participate, and simpler recruitment methods.Trial registrationCurrent Controlled Trials ISRCTN14569274.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 60. See the NIHR Journals Library website for further project information.

Research investigating structured, comprehensive numeracy curricula appropriate for children with Intellectual Disabilities (ID) is limited. We conducted a pilot study focused on an adaptation of the Maths Recovery program. Twenty four elementary school children with severe ID or autism were randomly allocated into the intervention and control groups. For 12 weeks, children in the intervention group received individualized numeracy teaching based on the adapted Maths Recovery curriculum, whereas children in the control group received “mathematics as usual” teaching. Pre- and post- intervention tests on standardized numeracy measures were conducted. Children were successfully recruited into the study, parents were willing for their child to be randomised to one of the arms of the study, and the vast majority of children were retained to follow-up. Analysis of data from outcome measures indicated that the Maths Recovery group made improvements at post-intervention in comparison to the control group. A follow-up test showed that gains were maintained 7 months after the end of the intervention. These pilot results support the case for a definitive research trial of the adapted Maths Recovery intervention.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects and costs of primary, secondary and tertiary strategies to prevent oral disease in dependent older people.

OBJECTIVE: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture.SETTING: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community.PARTICIPANTS: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.INTERVENTION: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary.PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers.RESULTS: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported.CONCLUSIONS: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT.TRIAL REGISTRATION NUMBER: ISRCTN22464643; Results.

This article, which is the first in a two-part series, provides an introduction to understanding quantitative research, basic statistics and terminology used in research articles. Critical appraisal of research articles is essential to ensure that nurses remain up to date with evidence-based practice to provide consistent and high-quality nursing care. This article focuses on developing critical appraisal skills and understanding the use and implications of different quantitative approaches to research. Part two of this article will focus on explaining common statistical terms and the presentation of statistical data in quantitative research.