ORCID Profile
0000-0001-8300-3204
Current Organisation
Newcastle University
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Publisher: Springer Science and Business Media LLC
Date: 20-05-2011
Publisher: Springer Science and Business Media LLC
Date: 11-04-2013
Publisher: National Institute for Health and Care Research
Date: 09-2020
DOI: 10.3310/PHR08130
Abstract: Looked-after children and care leavers (henceforth children in care) are young people placed under the care of local authorities, often because of a history of family abuse and/or neglect. These young people have significantly increased risk of substance use and mental health problems compared with peers. The Supporting Looked After Children and Care Leavers In Decreasing Drugs, and alcohol (SOLID) trial aimed to investigate the feasibility of a definitive randomised controlled trial comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol) in and improve the mental health of children in care aged 12–20 years. The study consisted of two phases: (1) a formative phase that adapted the motivational enhancement therapy and social behaviour and network therapy interventions for use with children in care and (2) a three-arm pilot randomised controlled trial (comparing motivational enhancement therapy, social behaviour and network therapy and usual care), and a linked process and economic (return on investment) evaluation. Trial feasibility was compared with prespecified STOP/GO criteria. Six local authority areas in the north-east of England. Children in care (aged 12–20 years) who screened positive for drug and/or alcohol use within the last 12 months were eligible for the trial. The formative and process evaluations included children in care, carers, social workers, and drug and alcohol workers. The primary outcomes were recruitment and retention rates at 12 months’ follow-up. Baseline and 12-month follow-up questionnaires measured self-reported drug and alcohol use, mental health and health-related quality of life. The process evaluation considered acceptability and engagement with the interventions and trial procedures. Formative findings ( n = 65) highlighted the need for interventions to increase the emphasis on therapeutic relationships, use creative methods of engagement and support the identification of treatment goals wider than substance misuse. Within the randomised controlled trial, of 860 participants screened, 211 (24.5%) met the inclusion criteria. One hundred and twelve (53%) of the 211 eligible children were recruited and randomised. Just 15 of the 76 (20%) participants allocated to intervention attended any of the motivational enhancement therapy of social behaviour and network therapy sessions, and 60 (54%) participants completed the 12-month follow-up. The screening and recruitment of children in care required significantly more time and resource investment by researchers and children’s services than planned. The process evaluation ( n = 116) demonstrated that, despite participants engaging in risky substance use, they did not often acknowledge this nor felt that they needed help. Children in care had complex, chaotic lives and children’s services departments were less research mature and extremely stretched this, coupled with the multiple steps in the intervention pathway and study protocol, resulted in low adherence to the intervention and the trial. The SOLID trial demonstrated successful engagement with children in care to adapt the motivational enhancement therapy and social behaviour and network therapy interventions. However, the pilot randomised controlled trial found that a definitive trial is not feasible. The current screen, refer and treat pathway for children in care did not work. There is an urgent need to radically rethink how we deliver therapeutic services for children in care. A pragmatic evaluation design, coupled with additional research resource for children’s services, is needed to evaluate these novel models of care at scale. This study is registered as PROSPERO CRD42018098974 and Current Controlled Trials ISRCTN80786829. This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research Vol. 8, No. 13. See the NIHR Journals Library website for further project information.
Publisher: Springer Science and Business Media LLC
Date: 09-2017
Publisher: National Institute for Health and Care Research
Date: 11-2016
DOI: 10.3310/HTA20850
Abstract: Many patients awaiting lung transplantation die before a donor organ becomes available. Ex vivo lung perfusion (EVLP) allows initially unusable donor lungs to be assessed and reconditioned for clinical use. The objective of the Donor Ex Vivo Lung Perfusion in UK lung transplantation study was to evaluate the clinical effectiveness and cost-effectiveness of EVLP in increasing UK lung transplant activity. A multicentre, unblinded, non-randomised, non-inferiority observational study to compare transplant outcomes between EVLP-assessed and standard donor lungs. Multicentre study involving all five UK officially designated NHS adult lung transplant centres. Patients aged ≥ 18 years with advanced lung disease accepted onto the lung transplant waiting list. The study intervention was EVLP assessment of donor lungs before determining suitability for transplantation. The primary outcome measure was survival during the first 12 months following lung transplantation. Secondary outcome measures were patient-centred outcomes that are influenced by the effectiveness of lung transplantation and that contribute to the health-care costs. Lungs from 53 donors unsuitable for standard transplant were assessed with EVLP, of which 18 (34%) were subsequently transplanted. A total of 184 participants received standard donor lungs. Owing to the early closure of the study, a non-inferiority analysis was not conducted. The Kaplan–Meier estimate of survival at 12 months was 0.67 [95% confidence interval (CI) 0.40 to 0.83] for the EVLP arm and 0.80 (95% CI 0.74 to 0.85) for the standard arm. The hazard ratio for overall 12-month survival in the EVLP arm relative to the standard arm was 1.96 (95% CI 0.83 to 4.67). Patients in the EVLP arm required ventilation for a longer period and stayed longer in an intensive therapy unit (ITU) than patients in the standard arm, but duration of overall hospital stay was similar in both groups. There was a higher rate of very early grade 3 primary graft dysfunction (PGD) in the EVLP arm, but rates of PGD did not differ between groups after 72 hours. The requirement for extracorporeal membrane oxygenation (ECMO) support was higher in the EVLP arm (7/18, 38.8%) than in the standard arm (6/184, 3.2%). There were no major differences in rates of chest radiograph abnormalities, infection, lung function or rejection by 12 months. The cost of EVLP transplants is approximately £35,000 higher than the cost of standard transplants, as a result of the cost of the EVLP procedure, and the increased ECMO use and ITU stay. Predictors of cost were quality of life on joining the waiting list, type of transplant and number of lungs transplanted. An exploratory model comparing a NHS lung transplant service that includes EVLP and standard lung transplants with one including only standard lung transplants resulted in an incremental cost-effectiveness ratio of £73,000. Interviews showed that patients had a good understanding of the need for, and the processes of, EVLP. If EVLP can increase the number of usable donor lungs and reduce waiting, it is likely to be acceptable to those waiting for lung transplantation. Study limitations include small numbers in the EVLP arm, limiting analysis to descriptive statistics and the EVLP protocol change during the study. Overall, one-third of donor lungs subjected to EVLP were deemed suitable for transplant. Estimated survival over 12 months was lower than in the standard group, but the data were also consistent with no difference in survival between groups. Patients receiving these additional transplants experience a higher rate of early graft injury and need for unplanned ECMO support, at increased cost. The small number of participants in the EVLP arm because of early study termination limits the robustness of these conclusions. The reason for the increased PGD rates, high ECMO requirement and possible differences in lung injury between EVLP protocols needs evaluation. Current Controlled Trials ISRCTN44922411. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 20, No. 85. See the NIHR Journals Library website for further project information.
Publisher: Wiley
Date: 15-08-2017
DOI: 10.1111/CCH.12505
Publisher: National Institute for Health and Care Research
Date: 11-2010
DOI: 10.3310/HTA14520
Abstract: To investigate the clinical effectiveness and cost-effectiveness of laxatives versus dietary and lifestyle advice, and standardised versus personalised dietary and lifestyle advice. A prospective, pragmatic, three-armed cluster randomised trial with an economic evaluation. General practices in England and Scotland, UK. People aged ≥ 55 years with chronic constipation, living in private households. Participants were identified as those who had been prescribed laxatives three or more times in the previous 12 months, or with a recorded diagnosis of chronic functional constipation. Prescription of laxatives, with class of laxative and dose at the discretion of the GP and patient (standard care control arm) standardised, non-personalised dietary and lifestyle advice and, personalised dietary and lifestyle advice, with reinforcement. The primary outcome was the constipation-specific Patient Assessment of Constipation-Symptoms (PAC-SYM)/Patient Assessment of Constipation-Quality of Life (PAC-QOL). The trial planned to recruit and retain 1425 patients from 57 practices (19 per arm) however, only 154 patients were recruited from 19 practices. Due to these low recruitment rates it was not possible to report the conventional trial findings. Baseline characteristics of the s le from data gathered from both postal self-completion questionnaires and face-to-face interviews suggest that our s le experienced very few symptoms of constipation (PAC-SYM) and that the condition itself did not have a major impact upon their quality of life (PAC-QOL). The low level of symptoms of constipation is most likely explained by 90% of the s le using a laxative in the previous week. Most participants in our s le were satisfied with the performance of their laxatives, and levels of anxiety and depression were low. Their fibre consumption was classified as 'moderate' but their average water consumption fell below the recommended guidelines. Daily diaries, completed each day for a period of 6 months, were analysed primarily in terms of overall response rate and item response rates, and the participants accepted this method of data collection. For the economic evaluation, all of the trial arms experienced a reduction in utility, as measured by EQ-5D. There was no statistical evidence to suggest that either the personalised intervention arm or the standardised intervention arm was associated with significant changes in utility at 3 months compared with the control arm. Data on related health-care costs show a cost saving of £13.34 for those in the personalised arm, compared with the control arm, and a smaller cost saving for the standardised arm. These savings primarily occurred because of reduced hospital costs. There was no significant change measured in utility, so the personalised arm appeared to be the preferred course, producing the greatest cost savings. Due to the low number of participants in the trial, no firm conclusions could be drawn about the effectiveness of the interventions. However, a number of factors that contributed to the conduct and progress of the trial are highlighted, which may be relevant to others conducting research on a similar topic or population. ISRCTN73881345. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 14, No. 52. See the HTA programme website for further project information.
Publisher: Wiley
Date: 16-04-2019
DOI: 10.1111/CCH.12659
Abstract: Consensus opinion supports standing frame use as part of postural management for nonambulant young people with cerebral palsy. Most young people with cerebral palsy in the United Kingdom, who use standing frames, use them at nursery or school, rather than at home. In this paper we report professionals' and parents' experiences and views of standing frame use specifically in educational settings. This research was conducted as part of a large mixed methods study to determine the acceptability and inform the design of a future trial of standing frames. Qualitative methods were used: focus groups with educational professionals, parents and clinicians (paediatricians, physiotherapists and occupational therapists) were convened. Data were analysed thematically using framework analysis. Five focus groups were conducted. The overarching theme "flexibility" encompassed four subordinate themes: (i) "balancing education and therapy," which described the way education professionals had to juggle different priorities from health professionals within a multi-disciplinary team (ii) "young people's autonomy," which highlighted participants' belief that standing frame use should be centred on the in idual young person and their needs (iii) "working within logistical boundaries," which demonstrated that "ideal" standing frame use was not always possible due to logistical issues (e.g., staffing and standing frame availability) and (iv) "competence and confidence," which highlighted that educational professionals felt that they lacked the training to confidently position young people in their standing frame. This paper highlights the complexity of standing frame use in the educational setting. If a standing frame programme is prescribed to be delivered in an educational setting, strong multidisciplinary and interagency communication is essential to balance therapy versus education. Training is required to ensure staff are competent in using the standing frame with the young person understanding their in idual requirements. A flexible approach-inclusive of the young person's needs, logistical demands and resource-is necessary.
Publisher: Springer Science and Business Media LLC
Date: 06-06-2014
Publisher: National Institute for Health and Care Research
Date: 09-2018
DOI: 10.3310/HTA22500
Abstract: Standing frames are recommended as part of postural management for young people with cerebral palsy (CP) Gross Motor Function Classification System (GMFCS) level IV or V. They may have a variety of benefits, including improving bone mineral density, gastrointestinal function and social participation. The NHS needs to know if these benefits are real, given the cost implications of use and the reported negative effects (e.g. pain). The lack of evidence for the clinical effectiveness of standing frames demonstrates the need for evaluative research. The aim of the study was to explore the acceptability of a future trial to determine the clinical effectiveness of standing frames. A sequential mixed-methods design was used. The findings of each stage informed the next stage. We conducted surveys, focus groups and in-depth interviews. Professionals who work with young people who use standing frames and parents who have a child who uses a standing frame took part in a survey of current standing frame practice ( n = 551), a series of focus groups (seven focus groups, 49 participants in total) and a survey of research trial acceptability and feasibility ( n = 585). Twelve young people who use a standing frame were interviewed. Standing frames were widely used as part of postural management for young people with CP both in school and at home but more frequently in school, and particularly by young people in primary school. Achieving the prescribed use was not always possible owing to resources, environment and family factors. Participation and activity engagement were important to young people. The majority of participants believed that standing frames research is necessary. Some reported concern that stopping standing frame use for a trial would cause irreversible damage. The maximum amount of time most health professionals and parents would agree to suspend standing frame use would be 12 weeks. Owing to the nature of recruitment, we could not calculate response rates or determine non-response bias. Therefore, participants may not be representative of all standing frame users. Although parents and professionals who engaged in the qualitative aspect of this research and stakeholders who took part in the design workshops appreciated the lack of clinical evidence, our surveys, qualitative information and PPI demonstrated that most people had strong beliefs regarding the clinical effectiveness of standing frames. However, with key stakeholder engagement and careful planning, a trial would be acceptable. We recommend a carefully planned trial that includes a pilot phase. The trial should evaluate the following question: ‘does using a standing frame in school improve patient-reported outcomes of participation (primary outcome), quality of life, subjective well-being, body function and body structure (secondary outcomes) in young children (aged 4–11 years) with CP GMFCS III–V?’. The National Institute for Health Research Health Technology Assessment programme.
Publisher: National Institute for Health and Care Research
Date: 06-2015
DOI: 10.3310/HTA19410
Abstract: The needs of children with autism spectrum disorder (ASD) are complex and this is reflected in the number and ersity of outcomes assessed and measurement tools used to collect evidence about children’s progress. Relevant outcomes include improvement in core ASD impairments, such as communication, social awareness, sensory sensitivities and repetitiveness skills such as social functioning and play participation outcomes such as social inclusion and parent and family impact. To examine the measurement properties of tools used to measure progress and outcomes in children with ASD up to the age of 6 years. To identify outcome areas regarded as important by people with ASD and parents. The MeASURe (Measurement in Autism Spectrum disorder Under Review) research collaboration included ASD experts and review methodologists. We undertook systematic review of tools used in ASD early intervention and observational studies from 1992 to 2013 systematic review, using the COSMIN checklist (Consensus-based Standards for the selection of health Measurement Instruments) of papers addressing the measurement properties of identified tools in children with ASD and synthesis of evidence and gaps. The review design and process was informed throughout by consultation with stakeholders including parents, young people with ASD, clinicians and researchers. The conceptual framework developed for the review was drawn from the International Classification of Functioning, Disability and Health, including the domains ‘Impairments’, ‘Activity Level Indicators’, ‘Participation’, and ‘Family Measures’. In review 1, 10,154 papers were sifted – 3091 by full text – and data extracted from 184 in total, 131 tools were identified, excluding observational coding, study-specific measures and those not in English. In review 2, 2665 papers were sifted and data concerning measurement properties of 57 (43%) tools were extracted from 128 papers. Evidence for the measurement properties of the reviewed tools was combined with information about their accessibility and presentation. Twelve tools were identified as having the strongest supporting evidence, the majority measuring autism characteristics and problem behaviour. The patchy evidence and limited scope of outcomes measured mean these tools do not constitute a ‘recommended battery’ for use. In particular, there is little evidence that the identified tools would be good at detecting change in intervention studies. The obvious gaps in available outcome measurement include well-being and participation outcomes for children, and family quality-of-life outcomes, domains particularly valued by our informants (young people with ASD and parents). This is the first systematic review of the quality and appropriateness of tools designed to monitor progress and outcomes of young children with ASD. Although it was not possible to recommend fully robust tools at this stage, the review consolidates what is known about the field and will act as a benchmark for future developments. With input from parents and other stakeholders, recommendations are made about priority targets for research. Priorities include development of a tool to measure child quality of life in ASD, and validation of a potential primary outcome tool for trials of early social communication intervention. This study is registered as PROSPERO CRD42012002223. The National Institute for Health Research Health Technology Assessment programme.
Publisher: Springer Science and Business Media LLC
Date: 22-09-2015
Publisher: Springer Science and Business Media LLC
Date: 15-11-2018
Publisher: Springer Science and Business Media LLC
Date: 15-11-2018
Publisher: Public Library of Science (PLoS)
Date: 18-04-2017
Publisher: Springer Science and Business Media LLC
Date: 04-01-2007
Abstract: The aim of the LIFELAX randomised controlled trial (diet and life style vs. lax atives in the management of chronic constipation) is to develop and evaluate a cost effective intervention to promote diet and lifestyle in the treatment and management of chronic constipation for older people in Primary Care. Constipation affects the quality of life in around 20% of older people in the community. In the 65 years plus population, a significant proportion of men and women both living in institutions (81% and 75% respectively) and free living (30% and 37% respectively) use laxatives. Approximately £42 million is spent each year on prescribed laxatives in England in addition to laxatives purchased over the counter. Although bowel problems are often multifactorial, diet and lifestyle have an extremely important role in their management. This paper describes one aspect of the main study, the development and piloting of the Patient information leaflets (PILs). Following review of the literature and interviews with practitioners and patients, 8 PILs were designed on: constipation, activity, bowel health, fruit and vegetables, fibre, fluid, alternative therapies and laxatives. To check the patient's understanding of terms used in the PILS and the clarity and accessibility of the information understanding, cognitive interviews (CI) were used with nine patients (selected from 3 GP surgeries), aged ≥ 55 years, who had received ≥ 3 prescriptions of laxatives over 12 months. Interviews were recorded and transcribed. Changes made following the CI process included the lay-out, words used (e.g. 'exercise' was changed to 'activity', 'gut motility' changed to 'bowel movement') and descriptions and ex les were adapted to be more appropriate for the target population. Pilot testing with CIs resulted in improvements in the PILs, which emphasises the need to pilot PILs with the target population before use. The techniques employed are relatively inexpensive and could be routinely used when preparing literature for research or clinical use including those intended for use with healthcare professionals and patients.
Publisher: Public Library of Science (PLoS)
Date: 14-03-2018
Publisher: National Institute for Health and Care Research
Date: 07-2016
DOI: 10.3310/HTA20560
Abstract: Falls cause fear, anxiety and loss of confidence, resulting in activity avoidance, social isolation and increasing frailty. The umbrella term for these problems is ‘fear of falling’, seen in up to 85% of older adults who fall. Evidence of effectiveness of physical and psychological interventions is limited, with no previous studies examining the role of an in idually delivered cognitive–behavioural therapy (CBT) approach. Primary objective To develop and then determine the effectiveness of a new CBT intervention (CBTi) delivered by health-care assistants (HCAs) plus usual care compared with usual care alone in reducing fear of falling. Secondary objectives To measure the impact of the intervention on falls, injuries, functional abilities, anxiety/depression, quality of life, social participation and loneliness investigate the acceptability of the intervention for patients, family members and professionals and factors that promote or inhibit its implementation and measure the costs and benefits of the intervention. Phase I CBTi development. Phase II Parallel-group patient randomised controlled trial (RCT) of the new CBTi plus usual care compared with usual care alone. Multidisciplinary falls services. Consecutive community-dwelling older adults, both sexes, aged ≥ 60 years, with excessive or undue fear of falling per Falls Efficacy Scale–International (FES-I) score of 23. Phase I Development of the CBTi. The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting. Phase II RCT. The CBTi was delivered by HCAs weekly for 8 weeks, with a 6-month booster session plus usual care. These were assessed at baseline, 8 weeks, 6 months and 12 months. Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months. Secondary outcome measures These comprised falls, injuries, anxiety/depression [Hospital Anxiety and Depression Scale (HADS)], quality of life, social participation, loneliness and measures of physical function. There were process and health-economic evaluations alongside the trial. Four hundred and fifteen patients were recruited, with 210 patients randomised to CBTi group and 205 to the control group. There were significant reductions in mean FES-I [–4.02 95% confidence interval (CI) –5.95 to –2.1], single-item numerical fear of falling scale (–1.42 95% CI –1.87 to 1.07) and HADS (–1 95% CI –1.6 to –0.3) scores at 12 months in the CBTi group compared with the usual care group. There were no differences in the other secondary outcome measures. Most patients found the CBTi acceptable. Factors affecting the delivery of the CBTi as part of routine practice were identified. There was no evidence that the intervention was cost-effective. Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services. There was no impact on other measures. Further work should focus on a joint CBTi and physical training approach to fear of falling, more rational targeting of CBTi, the possibility of mixed group and in idual CBTi, and the cost-effectiveness of provision of CBTi by non-specialists. Current Controlled Trials ISRCTN78396615. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 20, No. 56. See the NIHR Journals Library website for further project information.
Publisher: Wiley
Date: 23-11-2017
DOI: 10.1111/CCH.12540
Abstract: Consensus opinion supports standing frame use as part of postural management for nonambulant young people with cerebral palsy. Although the rationale for standing frame use and the associated challenges have been described, little attention has been given to the users' experiences. The aim of the current study was to explore young people's positive and negative experiences, and attitudes regarding standing frame use. Framework analysis informed an open exploration of young people's opinions of standing frames. Using semistructured interviews, 12 young people with cerebral palsy (6 female) were interviewed, providing the data set for transcription and thematic analysis. The first theme "attitudes to standing frames" describes the young people's understanding of why they use standing frames. Although standing frames can be painful, some young people believe they should be endured to improve their body structure and function. There were mixed views about the impact standing frames have socially, with some young people feeling excluded from their peers, and others feeling as though standing frames helped them "fit in." Some young people are not offered a choice about how and when they use their standing frame. The second theme "challenges of standing frame use" highlights the issues with standing frame use such as manual handling, interference from siblings, and the lack of aesthetically pleasing standing frame designs. Young people report benefits related to choice, pain relief, and participation but can also cause pain, discomfort, and reduced independence and participation. Healthcare professionals should have open, informative conversations about potential benefits and challenges of standing frames on all aspects of the young people's lives, including participation and activity.
Publisher: Springer Science and Business Media LLC
Date: 03-02-2014
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2012
End Date: 2016
Funder: Medical Research Council
View Funded ActivityStart Date: 2012
End Date: 2015
Funder: Economic and Social Research Council
View Funded Activity