Reply: SUN vs BEVþIFN in first-line mRCC therapy: no evidence for a statistically significant difference in progression-free survival

Copyright © 2015 Cancer Research UKThis is an BJC Open articleLetter to the Edito

Experiences of the ‘Nearest Relative’ provisions in the compulsory detention of people under the Mental Health Act: rapid systematic review

This is the final version. Available from NIHR Journals Library via the DOI in this record.Background Service users detained for assessment and/or treatment under the Mental Health Act 1983 are allocated a ‘Nearest Relative’. The Nearest Relative has access to confidential information about the service user, and can make decisions about their care and treatment. Tensions exist regarding the identification, displacement and powers of the Nearest Relative. Objectives To examine the experiences of service users, carers and relevant professionals of the Nearest Relative provisions of the Mental Health Act 1983, and the equivalent Named Person provisions in Scotland. Five research objectives were defined, understanding the experiences of and issues associated with i) identification of the Nearest Relative, ii) displacement of the Nearest Relative, iii) confidentiality and information sharing iv) access to support from carers and v) making decisions about treatment or care. Data sources Seven bibliographic databases: MEDLINE (via Ovid), MEDLINE In-Process & Other Non-Indexed Citations (via Ovid), PsycINFO (via Ovid), Social Policy and Practice (via Ovid), HMIC (via Ovid), CINAHL (via EBSCO) and ASSIA (via ProQuest). Citation searching, author contact and grey literature searches were conducted. Review methods A rapid systematic review was conducted in six weeks. Evidence published after 1998 was sought from the UK, pertaining to the experiences of those involved in compulsory detention under the Mental Health Act 1983 (or UK variants), including service users, carers, family members, Nearest Relatives, Named Persons, mental health professionals, policy makers and lawyers. Study selection, data extraction and critical appraisal were completed independently by two reviewers. We sought data about experiences obtained through qualitative means or surveys. Included studies containing several paragraphs of participant quotes and/or author interpretations were entered into a framework synthesis; the rest were summarised descriptively. The framework synthesis was based upon the five research objectives and refined using the findings of key studies from England and Scotland and inductive thematic analysis. Findings Twenty studies were included with 12 prioritised for framework synthesis. Four themes emerged i) issues regarding the identification of the Nearest Relative/Named Person, ii) confidentiality and information sharing, iii) enabling use of the Nearest Relative/Named Person role and iv) importance of maintaining relationships. The involvement of service users in choosing their representative and the role of services in supporting the Nearest Relative/Named Person was identified as important. Limitations There is little recent evidence to inform this important and complex discussion. The review was rigorously conducted despite the short timescale; however a more in-depth, iterative thematic analysis of all the included studies may have provided additional insights into the mechanisms underpinning the issues. Conclusions The Nearest Relative provisions of the Mental Health Act 1983 are complex and of significant importance to individuals detained under the Act and their carers. This rapid review provides specific examples of issues that individuals may experience. More research is needed to aid understanding of this complex topic. Future work Primary research specifically focussed on the perceived and actual use and impact of the Nearest Relative provisions in England and Scotland.This report was commissioned by the Department of Health and Social Care via the NIHR HS&DR programme as a review project within NIHR HS&DR programme project number 16/47/22

Whole-system approaches to improving the health and wellbeing of healthcare workers: A systematic review

This is the final version of the article. Available from Public Library of Science via the DOI in this record.BACKGROUND: Healthcare professionals throughout the developed world report higher levels of sickness absence, dissatisfaction, distress, and "burnout" at work than staff in other sectors. There is a growing call for the 'triple aim' of healthcare delivery (improving patient experience and outcomes and reducing costs; to include a fourth aim: improving healthcare staff experience of healthcare delivery. A systematic review commissioned by the United Kingdom's (UK) Department of Health reviewed a large number of international healthy workplace interventions and recommended five whole-system changes to improve healthcare staff health and wellbeing: identification and response to local need, engagement of staff at all levels, and the involvement, visible leadership from, and up-skilling of, management and board-level staff. OBJECTIVES: This systematic review aims to identify whole-system healthy workplace interventions in healthcare settings that incorporate (combinations of) these recommendations and determine whether they improve staff health and wellbeing. METHODS: A comprehensive and systematic search of medical, education, exercise science, and social science databases was undertaken. Studies were included if they reported the results of interventions that included all healthcare staff within a healthcare setting (e.g. whole hospital; whole unit, e.g. ward) in collective activities to improve physical or mental health or promote healthy behaviours. RESULTS: Eleven studies were identified which incorporated at least one of the whole-system recommendations. Interventions that incorporated recommendations to address local need and engage the whole workforce fell in to four broad types: 1) pre-determined (one-size-fits-all) and no choice of activities (two studies); or 2) pre-determined and some choice of activities (one study); 3) A wide choice of a range of activities and some adaptation to local needs (five studies); or, 3) a participatory approach to creating programmes responsive and adaptive to local staff needs that have extensive choice of activities to participate in (three studies). Only five of the interventions included substantial involvement and engagement of leadership and efforts aimed at up-skilling the leadership of staff to support staff health and wellbeing. Incorporation of more of the recommendations did not appear to be related to effectiveness. The heterogeneity of study designs, populations and outcomes excluded a meta-analysis. All studies were deemed by their authors to be at least partly effective. Two studies reported statistically significant improvement in objectively measured physical health (BMI) and eight in subjective mental health. Six studies reported statistically significant positive changes in subjectively assessed health behaviours. CONCLUSIONS: This systematic review identified 11 studies which incorporate at least one of the Boorman recommendations and provides evidence that whole-system healthy workplace interventions can improve health and wellbeing and promote healthier behaviours in healthcare staff.Funding provided in part to the European Centre for Environment and Human Health (part of the University of Exeter Medical School) by the European Regional Development Fund Programme 2007 to 2013 (https://www.gov.uk/guidance/erdf-programmes-and-resources) and European Social Fund Convergence Programme for Cornwall and the Isles of Scilly (http://www.erdfconvergence.org.uk/esf). This research was also funded in part by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula (http://clahrc-peninsula.nihr.ac.uk/) at the Royal Devon and Exeter NHS Foundation Trust (http://www.rdehospital.nhs.uk/). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

Sleep positioning systems for children and adults with a neurodisability: A systematic review

This is the author's accepted version.The final version is available from SAGE via the DOI in this record.Introduction: Sleep positioning systems are often prescribed as part of a 24-hour postural management programme for children and adults with neurodisabilities. In a search for evidence of effectiveness for children with cerebral palsy a recent Cochrane review found two randomised controlled trials. This review aims to appraise a broader set of studies including any neurological diagnosis and users of all ages to inform therapists about the quality of the evidence underlying practice. Method: A comprehensive search for all peer-reviewed studies that evaluated the use of sleep positioning systems was conducted in MEDLINE, EMBASE, CINAHL, Cochrane Library databases, BNI, HMIC, PEDro, OTSeeker and clinical trials registries. Disability organisations, manufacturers and colleagues worldwide were also contacted. Titles were screened for relevance by two reviewers. Data were extracted into bespoke quantitative or qualitative forms by one reviewer and checked by a second. Findings were analysed into simple themes. Results: A total of 14 studies were eligible for inclusion; all were small and most were of low quality. Inferences of benefits cannot be made from the literature but also no harm was found. Conclusions: The body of evidence supporting practice remains small and mostly of low quality. Therapists should remain cautious when presenting the benefits to families.This review was supported financially by the Posture and Mobility Group who had no other input into the study. We acknowledge support from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care of the South West Peninsula (PenCLAHRC) and the charity Cerebra

Patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review of patient reported outcomes and patient and clinician satisfaction

This is the final version of the article. Available from BioMed Central via the DOI in this record.BACKGROUND: The cost to the NHS of missed or inappropriate hospital appointments is considerable. Alternative methods of appointment scheduling might be more flexible to patients' needs without jeopardising health and service quality. The objective was to systematically review evidence of patient initiated clinics in secondary care on patient reported outcomes among patients with chronic/recurrent conditions. METHODS: Seven databases were searched from inception to June 2013. Hand searching of included studies references was also conducted. Studies comparing the effects of patient initiated clinics with traditional consultant led clinics in secondary care for patients with long term chronic or recurrent diseases on health related quality of life and/or patient satisfaction were included. Data was extracted by one reviewer and checked by a second. Results were synthesised narratively. RESULTS: Seven studies were included in the review, these covered a total of 1,655 participants across three conditions: breast cancer, inflammatory bowel disease and rheumatoid arthritis. Quality of reporting was variable. Results showed no significant differences between the intervention and control groups for psychological and health related quality of life outcomes indicating no evidence of harm. Some patients reported significantly more satisfaction using patient-initiated clinics than usual care (p < 0.001). CONCLUSIONS: The results show potential for patient initiated clinics to result in greater patient and clinician satisfaction. The patient-consultant relationship appeared to play an important part in patient satisfaction and should be considered an important area of future research as should the presence or absence of a guidebook to aid self-management. Patient initiated clinics fit the models of care suggested by policy makers and so further research into long term outcomes for patients and service use in this area of practice is both relevant and timely.This systematic review was funded by the National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health

The clinical effectiveness of patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review

This is the final version of the article. Available from Public Library of Science via the DOI in this record.BACKGROUND: Missed or inappropriate hospital appointments cost the UK National Health Service millions of pounds each year and delay treatment for other patients. Innovative methods of appointment scheduling that are more flexible to patient needs, may improve service quality and preserve resources. METHODS: A systematic review of the evidence for the clinical effectiveness of patient initiated clinics in managing long term care for people with chronic or recurrent conditions in secondary care. Seven databases were searched including MEDLINE, Embase and PsycINFO (using the OVID interface), the Cochrane Library of Systematic Reviews and CENTRAL, Science Citation Index Expanded, Social Sciences Citation Index, and Conference Proceedings Citation Index (via the Web of Science interface) from inception to June 2013. Studies comparing patient initiated clinics with traditional consultant-led clinics in secondary care for people with long term chronic or recurrent diseases were included. Included studies had to provide data on clinical or resource use outcomes. Data were extracted and checked by two reviewers using a piloted, standardised data extraction form. RESULTS: Eight studies (n = 1927 individuals) were included. All were conducted in the UK. There were few significant differences in clinical outcomes between the intervention and control groups. In some instances, using the patient initiated clinics model was associated with savings in time and resource use. The risk of harm from using the patient initiated clinic model of organising outpatient care is low. Studies with longer follow-up periods are needed to assess the long term costs and the ongoing risk of potential harms. CONCLUSIONS: The UK policy context is ripe for evidence-based, patient-centred services to be implemented, especially where the use of health care resources can be optimised without reducing the quality of care. Implementation of patient initiated clinics should remain cautious, with importance placed on ongoing evaluation of long term outcomes and costs.This systematic review was funded by the National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care for the South West. The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

Sleep positioning systems for children with cerebral palsy

PublishedArticleThis review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2015, Issue 11. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review.Background Sleep positioning systems can be prescribed for children with cerebral palsy to help reduce or prevent hip migration, provide comfort to ease pain and/or impr ove sleep. As sleep disturbance is common in children with developmental disabilities, with impact on their carers’ sleep, and as sleep positioning systems can be expensive, guidance is needed to support decisions as to their use. Objectives To determine whether commercially-available sleep positioning systems, compared with usual care, reduce or prevent hip migration in children with cerebral palsy. Any negative effect of sleep positioning systems on hip migration will be considered within this objective. Secondary objective s were to determine the effect of sleep positioning systems on: (1) number or frequency of hip problems; (2) sleep patterns and quality; (3) quality of life of the child and family; (4) pain; and (5) physical functioning. We also sought to identify any adverse effects from using sleep positioning systems. Search methods In December 2014, we se arched CENTRAL, Ovid MEDLINE, Embase, and 13 other databases. We also searched two trials registers. We applied no restrictions on date of publication, language, publication status or study design. We checked references and contacted manufacturers and authors for potentially relevant literature , and searched the internet using Google. Selection criteria We included all randomised controlled trials (RCTs) evaluating whole body sleep positioning systems for children and adolescents (up to 18 years of age) with cerebral palsy. Data collection and analysis Two review authors independently screened reports retrieved from the search against pre-determined inclusion criteria and assessed the quality of eligible studies. Members of the public (parent carers of children with neurodisability) contributed to this review by suggesting the topic, refining the research objectives, interpreting the findings, and reviewing the plain language summaryNIHRCerebra, U

Dietary interventions for recurrent abdominal pain in childhood

This is the final version of the article. Available from Wiley via the DOI in this record.BACKGROUND: This is an update of the original Cochrane review, last published in 2009 (Huertas-Ceballos 2009). Recurrent abdominal pain (RAP), including children with irritable bowel syndrome, is a common problem affecting between 4% and 25% of school-aged children. For the majority of such children, no organic cause for their pain can be found on physical examination or investigation. Many dietary inventions have been suggested to improve the symptoms of RAP. These may involve either excluding ingredients from the diet or adding supplements such as fibre or probiotics. OBJECTIVES: To examine the effectiveness of dietary interventions in improving pain in children of school age with RAP. SEARCH METHODS: We searched CENTRAL, Ovid MEDLINE, Embase, eight other databases, and two trials registers, together with reference checking, citation searching and contact with study authors, in June 2016. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing dietary interventions with placebo or no treatment in children aged five to 18 years with RAP or an abdominal pain-related, functional gastrointestinal disorder, as defined by the Rome III criteria (Rasquin 2006). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We grouped dietary interventions together by category for analysis. We contacted study authors to ask for missing information and clarification, when needed. We assessed the quality of the evidence for each outcome using the GRADE approach. MAIN RESULTS: We included 19 RCTs, reported in 27 papers with a total of 1453 participants. Fifteen of these studies were not included in the previous review. All 19 RCTs had follow-up ranging from one to five months. Participants were aged between four and 18 years from eight different countries and were recruited largely from paediatric gastroenterology clinics. The mean age at recruitment ranged from 6.3 years to 13.1 years. Girls outnumbered boys in most trials. Fourteen trials recruited children with a diagnosis under the broad umbrella of RAP or functional gastrointestinal disorders; five trials specifically recruited only children with irritable bowel syndrome. The studies fell into four categories: trials of probiotic-based interventions (13 studies), trials of fibre-based interventions (four studies), trials of low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diets (one study), and trials of fructose-restricted diets (one study).We found that children treated with probiotics reported a greater reduction in pain frequency at zero to three months postintervention than those given placebo (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.98 to -0.12; 6 trials; 523 children). There was also a decrease in pain intensity in the intervention group at the same time point (SMD -0.50, 95% CI -0.85 to -0.15; 7 studies; 575 children). However, we judged the evidence for these outcomes to be of low quality using GRADE due to an unclear risk of bias from incomplete outcome data and significant heterogeneity.We found that children treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (odds ratio (OR) 1.63, 95% CI 1.07 to 2.47; 7 studies; 722 children). The estimated number needed to treat for an additional beneficial outcome (NNTB) was eight, meaning that eight children would need to receive probiotics for one to experience improvement in pain in this timescale. We judged the evidence for this outcome to be of moderate quality due to significant heterogeneity.Children with a symptom profile defined as irritable bowel syndrome treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (OR 3.01, 95% CI 1.77 to 5.13; 4 studies; 344 children). Children treated with probiotics were more likely to experience improvement in pain at three to six months postintervention compared to those receiving placebo (OR 1.94, 95% CI 1.10 to 3.43; 2 studies; 224 children). We judged the evidence for these two outcomes to be of moderate quality due to small numbers of participants included in the studies.We found that children treated with fibre-based interventions were not more likely to experience an improvement in pain at zero to three months postintervention than children given placebo (OR 1.83, 95% CI 0.92 to 3.65; 2 studies; 136 children). There was also no reduction in pain intensity compared to placebo at the same time point (SMD -1.24, 95% CI -3.41 to 0.94; 2 studies; 135 children). We judged the evidence for these outcomes to be of low quality due to an unclear risk of bias, imprecision, and significant heterogeneity.We found only one study of low FODMAP diets and only one trial of fructose-restricted diets, meaning no pooled analyses were possible.We were unable to perform any meta-analyses for the secondary outcomes of school performance, social or psychological functioning, or quality of daily life, as not enough studies included these outcomes or used comparable measures to assess them.With the exception of one study, all studies reported monitoring children for adverse events; no major adverse events were reported. AUTHORS' CONCLUSIONS: Overall, we found moderate- to low-quality evidence suggesting that probiotics may be effective in improving pain in children with RAP. Clinicians may therefore consider probiotic interventions as part of a holistic management strategy. However, further trials are needed to examine longer-term outcomes and to improve confidence in estimating the size of the effect, as well as to determine the optimal strain and dosage. Future research should also explore the effectiveness of probiotics in children with different symptom profiles, such as those with irritable bowel syndrome.We found only a small number of trials of fibre-based interventions, with overall low-quality evidence for the outcomes. There was therefore no convincing evidence that fibre-based interventions improve pain in children with RAP. Further high-quality RCTs of fibre supplements involving larger numbers of participants are required. Future trials of low FODMAP diets and other dietary interventions are also required to facilitate evidence-based recommendations

Psychosocial interventions for recurrent abdominal pain in childhood

This is the final version. Available from the publisher via the DOI in this record.BACKGROUND: This review supersedes the original Cochrane review first published in 2008 (Huertas-Ceballos 2008).Between 4% and 25% of school-aged children complain of recurrent abdominal pain (RAP) severe enough to interfere with their daily activities. No organic cause for this pain can be found on physical examination or investigation for the majority of such children. Although many children are managed by reassurance and simple measures, a large range of psychosocial interventions involving cognitive and behavioural components have been recommended. OBJECTIVES: To determine the effectiveness of psychosocial interventions for reducing pain in school-aged children with RAP. SEARCH METHODS: In June 2016 we searched CENTRAL, MEDLINE, Embase, eight other databases, and two trials registers. We also searched the references of identified studies and relevant reviews. SELECTION CRITERIA: Randomised controlled trials comparing psychosocial therapies with usual care, active control, or wait-list control for children and adolescents (aged 5 to 18 years) with RAP or an abdominal pain-related functional gastrointestinal disorder defined by the Rome III criteria were eligible for inclusion. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Five review authors independently selected studies, assessed them for risk of bias, and extracted relevant data. We also assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: This review includes 18 randomised controlled trials (14 new to this version), reported in 26 papers, involving 928 children and adolescents with RAP between the ages of 6 and 18 years. The interventions were classified into four types of psychosocial therapy: cognitive behavioural therapy (CBT), hypnotherapy (including guided imagery), yoga, and written self-disclosure. The studies were carried out in the USA, Australia, Canada, the Netherlands, Germany, and Brazil. The majority of the studies were small and short term; only two studies included more than 100 participants, and only five studies had follow-up assessments beyond six months. Small sample sizes and the degree of assessed risk of performance and detection bias in many studies led to the overall quality of the evidence being rated as low to very low for all outcomes.For CBT compared to control, we found evidence of treatment success postintervention (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.18 to 27.32; Z = 2.16; P = 0.03; 4 studies; 175 children; very low-quality evidence), but no evidence of treatment success at medium-term follow-up (OR 3.08, 95% CI 0.93 to 10.16; Z = 1.85; P = 0.06; 3 studies; 139 children; low-quality evidence) or long-term follow-up (OR 1.29, 95% CI 0.50 to 3.33; Z = 0.53; P = 0.60; 2 studies; 120 children; low-quality evidence). We found no evidence of effects of intervention on pain intensity scores measured postintervention (standardised mean difference (SMD) -0.33, 95% CI -0.74 to 0.08; 7 studies; 405 children; low-quality evidence), or at medium-term follow-up (SMD -0.32, 95% CI -0.85 to 0.20; 4 studies; 301 children; low-quality evidence).For hypnotherapy (including studies of guided imagery) compared to control, we found evidence of greater treatment success postintervention (OR 6.78, 95% CI 2.41 to 19.07; Z = 3.63; P = 0.0003; 4 studies; 146 children; low-quality evidence) as well as reductions in pain intensity (SMD -1.01, 95% CI -1.41 to -0.61; Z = 4.97; P < 0.00001; 4 studies; 146 children; low-quality evidence) and pain frequency (SMD -1.28, 95% CI -1.84 to -0.72; Z = 4.48; P < 0.00001; 4 studies; 146 children; low-quality evidence). The only study of long-term effect reported continued benefit of hypnotherapy compared to usual care after five years, with 68% reporting treatment success compared to 20% of controls (P = 0.005).For yoga therapy compared to control, we found no evidence of effectiveness on pain intensity reduction postintervention (SMD -0.31, 95% CI -0.67 to 0.05; Z = 1.69; P = 0.09; 3 studies; 122 children; low-quality evidence).The single study of written self-disclosure therapy reported no benefit for pain.There was no evidence of effect from the pooled analyses for any type of intervention on the secondary outcomes of school performance, social or psychological functioning, and quality of daily life.There were no adverse effects for any of the interventions reported. AUTHORS' CONCLUSIONS: The data from trials to date provide some evidence for beneficial effects of CBT and hypnotherapy in reducing pain in the short term in children and adolescents presenting with RAP. There was no evidence for the effectiveness of yoga therapy or written self-disclosure therapy. There were insufficient data to explore effects of treatment by RAP subtype.Higher-quality, longer-duration trials are needed to fully investigate the effectiveness of psychosocial interventions. Identifying the active components of the interventions and establishing whether benefits are sustained in the long term are areas of priority. Future research studies would benefit from employing active control groups to help minimise potential bias from wait-list control designs and to help account for therapist and intervention time.The work of the evidence synthesis team is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula (PenCLAHRC). However, the funder had no role in the review itself

Can person-centred care for people living with dementia be delivered in the acute care setting?

This is the final version. Available from Oxford University Press / British Geriatrics Society via the DOI in this record. The need to improve care for people living with dementia in the hospital setting has long been recognised. Person-centred care has the potential to improve the experience of care for persons living with dementia and their carers, and has been shown to improve the experiences of hospital staff caring for the persons living with dementia, however it remains challenging to deliver in a time- and task-focussed acute care setting. This commentary suggests that to embed person-centred care across the hospital environment, cultural changes are needed at organisational and ward levels. In particular there needs to be: leadership that supports and advocates for workforce capacity to recognise and meet both psychological and physical needs of people living with dementia, promotion of physical environments that support familiarisation and social interactions, an inclusive approach to carers and the development of a culture of sharing knowledge and information across hierarchies and roles. An evidence-based set of pointers for service change are described which highlight institutional and environmental practices and processes that need to be addressed in order for person-centred care to become part of routine care.National Institute for Health Research (NIHR)National Institute for Health Research (NIHR