Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.

Background: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews: studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children's workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration: This study is registered as PROSPERO CRD42019159008. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.

Between 5% and 30% of children experience constipation at some stage. In one-third of these children, this progresses to chronic functional constipation. Chronic functional constipation affects more children with additional needs. We aimed to find and bring together published information about treatments for chronic functional constipation, to help establish best treatments and treatment combinations. We did not cover assessment or diagnosis of chronic functional constipation. This project was guided by a 'stakeholder group', including parents of children with constipation, people who experienced constipation as children, and healthcare professionals/continence experts. We carried out a 'scoping review' and a series of 'systematic reviews'. Our 'scoping review' provides an overall picture of research about treatments, with 651 studies describing 48 treatments. This helps identify important evidence gaps. 'Systematic reviews' are robust methods of bringing together and interpreting research evidence. Our stakeholder group decided to structure our systematic reviews to reflect who delivered the interventions. We brought together evidence about how well treatments worked when delivered by families/carers (32 studies), the wider children's workforce (e.g. general practitioner, health visitor) (21 studies), continence teams (31 studies) or specialist consultant-led teams (42 studies). We also considered complementary therapies (15 studies) and behavioural strategies (4 studies). Care is affected by what is done and how it is done. We brought together evidence about different models of delivering care (15 studies), barriers and facilitators to implementation of treatments (106 studies) and costs (31 studies). Quality of evidence was mainly low to very low. Despite numerous studies, there was often insufficient information to support generalisable conclusions. Our findings generally agreed with current clinical guidelines. Management of childhood chronic functional constipation should be child-centred, multifaceted and adapted according to the individual child, their needs, the situation in which they live and the health-care setting in which they are looked after. Research is needed to address our identified evidence gaps.

Investigating Scottish Long COVID community rehabilitation service models from the perspectives of people living with Long COVID and healthcare professionals: a qualitative descriptive study.

OBJECTIVES: This study aimed to explore the perceptions and experiences of barriers and facilitators to accessing Long COVID community rehabilitation. DESIGN: We used a qualitative descriptive design over two rounds of data collection with three participant groups: (1) people with experience of rehabilitation for Long COVID (PwLC); (2) National Health Service (NHS) staff delivering and/or managing community rehabilitation services (allied health professionals (AHPs)) and (3) NHS staff involved in strategic planning around Long COVID in their health board (Long COVID leads). SETTING: Four NHS Scotland territorial health boards. PARTICIPANTS: 51 interviews: eight Long COVID leads (11 interviews); 15 AHPs (25 interviews) and 15 PwLC (15 interviews). RESULTS: Three key themes were identified: (1) accessing care for PwLC, (2) understanding Long COVID and its management and (3) strengths and limitations of existing Long COVID rehabilitation services. CONCLUSIONS: Organisational delivery of Long COVID community rehabilitation is complex and presents multiple challenges. In addition, access to Long COVID community rehabilitation can be challenging. When accessed, these services are valued by PwLC but require adequate planning, publicity and resource. The findings presented here can be used by those developing and delivering services for people with Long COVID.

Right at Home: Living with Dementia and Multimorbidities.

Dementia is recognised as the biggest health crisis of our time in terms of high personal and social costs and wider impact on health and social care systems. Increases in people living with dementia and multimorbidities presents critical challenges for homecare worldwide. Healthcare systems struggle to provide adequate home-care services, delivering limited care restricted to a single-condition focus. This study explored the experiences and expectations of homecare from the multiple perspectives of people living with dementia and multimorbidities and homecare workers providing support. Findings draw from qualititative semi-structured interviews with people with dementia (n=2), their partners (n=2), other partners or family carers (n=6) and homecare workers (n=26). Three themes are idenfiifed: (a) the preference for and value of home; (b) inadequate homecare provision and enhanced care-burden; (c) limited training and education. Despite continued calls for homecare investment, the focus on reduction in costs hides key questions and further dialogue required exploring how people with dementia can be supported to live independendently and flourish at-home. This study considers these complex experiences and care requirements through the prism of disability and human rights frameworks. This paper concludes with consideration of more recent human social rights debate. We critically dicuss what this may mean for people living with dementia and consider the implications for corequisite policy development to optimise available homecare support.

Evaluation of the impact of an augmented model of The Productive Ward: Releasing Time to Care on staff and patient outcomes: a naturalistic stepped-wedge trial.

BACKGROUND: Improving the quality and efficiency of healthcare is an international priority. A range of complex ward based quality initiatives have been developed over recent years, perhaps the most influential programme has been Productive Ward: Releasing Time to Care. The programme aims to improve work processes and team efficiency with the aim of 'releasing time', which would be used to increase time with patients ultimately improving patient care, although this does not form a specific part of the programme. This study aimed to address this and evaluate the impact using recent methodological advances in complex intervention evaluation design. METHOD: The objective of this study was to assess the impact of an augmented version of The Productive Ward: Releasing Time to Care on staff and patient outcomes. The design was a naturalistic stepped-wedge trial. The setting included fifteen wards in two acute hospitals in a Scottish health board region. The intervention was the Productive Ward: Releasing Time to Care augmented with practice development transformational change methods that focused on staff caring behaviours, teamwork and patient feedback. The primary outcomes included nurses' shared philosophy of care, nurse emotional exhaustion, and patient experience of nurse communication. Secondary outcomes covered additional key dimensions of staff and patient experience and outcomes and frequency of emergency admissions for same diagnosis within 6 months of discharge. RESULTS: We recruited 691 patients, 177 nurses and 14 senior charge nurses. We found statistically significant improvements in two of the study's three primary outcomes: patients' experiences of nurse communication (Effect size=0.15, 95% CI; 0.05 to 0.24), and nurses' shared philosophy of care (Effect size =0.42, 95% CI; 0.14 to 0.70). There were also significant improvements in secondary outcomes: patients' overall rating of ward quality; nurses' positive affect; and items relating to nursing team climate. We found no change in frequency of emergency admissions within six months of discharge. CONCLUSIONS: We found evidence that the augmented version of The Productive Ward: Releasing Time to Care Intervention was successful in improving a number of dimensions of nurse experience and ward culture, in addition to improved patient experience and evaluations of the quality of care received. Despite these positive summary findings across all wards, intervention implementation appeared to vary between wards. By addressing the contextual factors, which may influence these variations, and tailoring some elements of the intervention, it is likely that greater improvements could be achieved. TRIAL REGISTRATION NUMBER: UKCRN 14195.

Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review.

BACKGROUND: Evidence from disease epidemics shows that healthcare workers are at risk of developing short- and long-term mental health problems. The World Health Organization (WHO) has warned about the potential negative impact of the COVID-19 crisis on the mental well-being of health and social care professionals. Symptoms of mental health problems commonly include depression, anxiety, stress, and additional cognitive and social problems; these can impact on function in the workplace. The mental health and resilience (ability to cope with the negative effects of stress) of frontline health and social care professionals ('frontline workers' in this review) could be supported during disease epidemics by workplace interventions, interventions to support basic daily needs, psychological support interventions, pharmacological interventions, or a combination of any or all of these. OBJECTIVES: Objective 1: to assess the effects of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. Objective 2: to identify barriers and facilitators that may impact on the implementation of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. SEARCH METHODS: On 28 May 2020 we searched the Cochrane Database of Systematic Reviews, CENTRAL, MEDLINE, Embase, Web of Science, PsycINFO, CINAHL, Global Index Medicus databases and WHO Institutional Repository for Information Sharing. We also searched ongoing trials registers and Google Scholar. We ran all searches from the year 2002 onwards, with no language restrictions. SELECTION CRITERIA: We included studies in which participants were health and social care professionals working at the front line during infectious disease outbreaks, categorised as epidemics or pandemics by WHO, from 2002 onwards. For objective 1 we included quantitative evidence from randomised trials, non-randomised trials, controlled before-after studies and interrupted time series studies, which investigated the effect of any intervention to support mental health or resilience, compared to no intervention, standard care, placebo or attention control intervention, or other active interventions. For objective 2 we included qualitative evidence from studies that described barriers and facilitators to the implementation of interventions. Outcomes critical to this review were general mental health and resilience. Additional outcomes included psychological symptoms of anxiety, depression or stress; burnout; other mental health disorders; workplace staffing; and adverse events arising from interventions. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently applied selection criteria to abstracts and full papers, with disagreements resolved through discussion. One review author systematically extracted data, cross-checked by a second review author. For objective 1, we assessed risk of bias of studies of effectiveness using the Cochrane 'Risk of bias' tool. For objective 2, we assessed methodological limitations using either the CASP (Critical Appraisal Skills Programme) qualitative study tool, for qualitative studies, or WEIRD (Ways of Evaluating Important and Relevant Data) tool, for descriptive studies. We planned meta-analyses of pairwise comparisons for outcomes if direct evidence were available. Two review authors extracted evidence relating to barriers and facilitators to implementation, organised these around the domains of the Consolidated Framework of Implementation Research, and used the GRADE-CERQual approach to assess confidence in each finding. We planned to produce an overarching synthesis, bringing quantitative and qualitative findings together. MAIN RESULTS: We included 16 studies that reported implementation of an intervention aimed at supporting the resilience or mental health of frontline workers during disease outbreaks (severe acute respiratory syndrome (SARS): 2; Ebola: 9; Middle East respiratory syndrome (MERS): 1; COVID-19: 4). Interventions studied included workplace interventions, such as training, structure and communication (6 studies); psychological support interventions, such as counselling and psychology services (8 studies); and multifaceted interventions (2 studies). Objective 1: a mixed-methods study that incorporated a cluster-randomised trial, investigating the effect of a work-based intervention, provided very low-certainty evidence about the effect of training frontline healthcare workers to deliver psychological first aid on a measure of burnout. Objective 2: we included all 16 studies in our qualitative evidence synthesis; we classified seven as qualitative and nine as descriptive studies. We identified 17 key findings from multiple barriers and facilitators reported in studies. We did not have high confidence in any of the findings; we had moderate confidence in six findings and low to very low confidence in 11 findings. We are moderately confident that the following two factors were barriers to intervention implementation: frontline workers, or the organisations in which they worked, not being fully aware of what they needed to support their mental well-being; and a lack of equipment, staff time or skills needed for an intervention. We are moderately confident that the following three factors were facilitators of intervention implementation: interventions that could be adapted for local needs; having effective communication, both formally and socially; and having positive, safe and supportive learning environments for frontline workers. We are moderately confident that the knowledge or beliefs, or both, that people have about an intervention can act as either barriers or facilitators to implementation of the intervention. AUTHORS' CONCLUSIONS: There is a lack of both quantitative and qualitative evidence from studies carried out during or after disease epidemics and pandemics that can inform the selection of interventions that are beneficial to the resilience and mental health of frontline workers. Alternative sources of evidence (e.g. from other healthcare crises, and general evidence about interventions that support mental well-being) could therefore be used to inform decision making. When selecting interventions aimed at supporting frontline workers' mental health, organisational, social, personal, and psychological factors may all be important. Research to determine the effectiveness of interventions is a high priority. The COVID-19 pandemic provides unique opportunities for robust evaluation of interventions. Future studies must be developed with appropriately rigorous planning, including development, peer review and transparent reporting of research protocols, following guidance and standards for best practice, and with appropriate length of follow-up. Factors that may act as barriers and facilitators to implementation of interventions should be considered during the planning of future research and when selecting interventions to deliver within local settings.

The barriers and facilitators influencing the sustainability of hospital-based interventions: a systematic review.

BACKGROUND: Identifying factors that influence sustained implementation of hospital-based interventions is key to ensuring evidence-based best practice is maintained across the NHS. This study aimed to identify, appraise and synthesise the barriers and facilitators that influenced the delivery of sustained healthcare interventions in a hospital-based setting. METHODS: A systematic review reported in accordance with PRISMA. Eight electronic databases were reviewed in addition to a hand search of Implementation Science journal and reference lists of included articles. Two reviewers were used to screen potential abstracts and full text papers against a selection criteria. Study quality was also independently assessed by two reviewers. Barriers and facilitators were extracted and mapped to a consolidated sustainability framework. RESULTS: Our searching identified 154,757 records. We screened 14,626 abstracts and retrieved 431 full text papers, of which 32 studies met the selection criteria. The majority of studies employed a qualitative design (23/32) and were conducted in the UK (8/32) and the USA (8/32). Interventions or programmes were all multicomponent, with the majority aimed at improving the quality of patient care and/ or safety (22/32). Sustainability was inconsistently reported across 30 studies. Barriers and facilitators were reported in all studies. The key facilitators included a clear accountability of roles and responsibilities (23/32); ensuring the availability of strong leadership and champions advocating the use of the intervention (22/32), and provision of adequate support available at an organisational level (21/32). The most frequently reported barrier to sustainability was inadequate staff resourcing (15/32). Our review also identified the importance of inwards spread and development of the initiative over time, as well as the unpredictability of sustainability and the need for multifaceted approaches. CONCLUSIONS: This review has important implications for practice and research as it increases understanding of the factors that faciliate and hinder intervention sustainability. It also highlights the need for more consistent and complete reporting of sustainability to ensure that lessons learned can be of direct benefit to future implementation of interventions. TRIAL REGISTRATION: The review is registered on PROSPERO ( CRD42017081992 ).

A national survey of community rehabilitation service provision for people with long Covid in Scotland.

Background: Over 50 million cases of COVID-19 have been confirmed globally as of November 2020. Evidence is rapidly emerging on the epidemiology of COVID-19, and its impact on individuals and potential burden on health services and society. Between 10-35% of people with COVID-19 may experience post-acute long Covid. This currently equates to between 8,129 and 28,453 people in Scotland. Some of these people will require rehabilitation to support their recovery. Currently, we do not know how to optimally configure community rehabilitation services for people with long Covid. Methods: This national survey aimed to provide a detailed description of current community rehabilitation provision for people with long Covid in Scotland. We developed, piloted, and conducted a national electronic survey of current community rehabilitation service provision for people presenting with long Covid symptomatology. Our sample were the Allied Health Professions Directors of all 14 territorial NHS Health Boards in Scotland. Fixed response and narrative data were analysed descriptively. Results: Responses were received from all respondents (14/14), enabling a national picture to be gained. Almost all Health Boards (13/14) currently deliver rehabilitation for people with long Covid within pre-existing services. Fatigue (11/14) and respiratory conditions (9/14) were the two most common presenting problems of patients. Most long Covid community rehabilitation services are delivered through a combination of face-to-face and digital contact (13/14). Conclusions: Community rehabilitation for people with long Covid is an emerging reality. This survey provides a national picture of current community rehabilitation for people with long Covid. We do not know how community rehabilitation can be optimally delivered for this population. This is vital as community rehabilitation services were already under pressure prior to the emergence of COVID-19. Further research is urgently required to investigate the implementation, outcomes and cost-effectiveness of differing models of community rehabilitation for this patient population.

Understanding the training and education needs of homecare workers supporting people with dementia and cancer: A systematic review of reviews.

Many people with dementia, supported by family carers, prefer to live at home and may rely on homecare support services. People with dementia are also often living with multimorbidities, including cancer. The main risk factor for both cancer and dementia is age and the number of people living with dementia and cancer likely to rise. Upskilling the social care workforce to facilitate more complex care is central to national workforce strategies and challenges. Training and education development must also respond to the key requirements of a homecare workforce experiencing financial, recruitment and retention difficulties. This systematic review of reviews provides an overview of dementia and cancer training and education accessible to the homecare workforce. Findings reveal there is a diverse range of training and education available, with mixed evidence of effectiveness. Key barriers and facilitators to effective training and education are identified in order to inform future training, education and learning development for the homecare workforce supporting people with dementia and cancer.

An exploration of how domains of quality of care relate to overall care experience.

PURPOSE: The purpose of this paper is to determine the relative influence of the different domains of healthcare quality from the Care Experience Feedback Improvement Tool (CEFIT) and identify key predictors of healthcare quality from the patients' perspective. Measurement is necessary to determine whether the quality of healthcare is improving. The CEFIT was developed as a brief measure of patient experience. It is important to determine the relative influence of the different domains of healthcare quality to further clarify how the CEFIT can be used and identify key predictors of healthcare quality from the patients' perspective. DESIGN/METHODOLOGY/APPROACH: In sum, 802 people with a healthcare experience during the previous 12 months were telephoned to complete the CEFIT questions and an additional 11-point global rating of patient experience. To estimate the influence of different domains of healthcare quality on patient overall ratings of quality of healthcare experience, the authors regressed the overall rating of patient experience with each component of quality (safety, effectiveness, timely, caring, enables system navigation and person-centred). FINDINGS: The authors found that all of the domains of the CEFIT influenced patient experience ratings of healthcare quality. Specifically, results show the degree of influence, the impact of demographics and how high scores for overall rating of patient experience can be predicted. ORIGINALITY/VALUE: The findings suggest that all of the CEFIT domains are important in terms of capturing the wholeness of the patient experience of healthcare quality to direct local quality improvement.

Loneliness and social isolation causal association with health-related lifestyle risk in older adults: a systematic review and meta-analysis protocol.

BACKGROUND: The health impacts of loneliness and social isolation among older adults are widely acknowledged. Despite this, there is no consensus on the possible causal nature of this relationship, which could undermine effectiveness of interventions. One body of thought is that loneliness and social isolation affect health-related behaviours to indirectly damage health. However, there has not been any systematic assessment of the association between loneliness and social isolation and health-related behaviours which considers the possible impact from confounding factors and the causal direction of this association. METHODS/DESIGN: The research will comprise a systematic review and meta-analysis to address the evidence gap. EMBASE, MEDLINE, PSYCINFO, CINAHL, SocIndex, Scopus and Web of Science will be systematically searched for quantitative observational studies considering an association between loneliness/social isolation and key health-related behaviours in older adults. Two reviewers will independently check the study titles and abstracts for eligibility. Included studies will be critically appraised using Newcastle-Ottawa Scale by the lead author and checked by the second reviewer. Discrepancies in eligibility or quality assessment will be resolved via discussion or referral to a third reviewer. Results will be synthesised and reported in accordance with the Centre for Reviews and Dissemination (CRD) guidelines. This will be in the form of a descriptive summary, risk of bias assessment together with a meta-analysis and sub-group analyses (for covariate adjusted results) where sufficient heterogeneity of results is established. Finally, any associations identified will be analysed using the Bradford-Hill criteria to explore causal relationships which, if they exist, will be reported by means of a computed causations score. DISCUSSION: This review aims to assess the extent and causal nature of associations between loneliness/social isolation and health-related behaviours among older adults. This data will provide a comprehensive overview of the quality of the evidence base to inform stakeholders in tackling the growing public health challenges arising from loneliness/social isolation in ageing populations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017020845.

Electronic Swallowing Intervention Package to Support Swallowing Function in Patients With Head and Neck Cancer: Development and Feasibility Study.

BACKGROUND: Many patients undergoing treatment for head and neck cancer (HNC) experience significant swallowing difficulties, and there is some evidence that swallowing exercises may improve outcomes, including quality of life. This feasibility study developed an evidence-based, practical Swallowing Intervention Package (SiP) for patients undergoing chemoradiotherapy (CRT) for HNC. As part of the study, an electronic version of SiP (e-SiP) was concurrently developed to support patients to self-manage during treatment. This paper reports on the e-SiP component of this work. OBJECTIVE: The objective of our study was to develop and conduct a preliminary evaluation of an electronic support system (e-SiP) for patients undergoing CRT for HNC. METHODS: The study was conducted using a recognized mHealth development and evaluation framework and involved health professionals and patients who were undergoing CRT for HNC. The scoping stage of e-SiP development investigated the potential usefulness of the app, exploring how e-SiP would look and feel and what content would be appropriate to provide. Patient and carer focus groups and a health professionals' consensus day were used as means of data gathering around potential e-SiP content. A repeat focus group looked at an outline version of e-SiP and informed the next stage of its development with regard to refining the requirements for the tool. This was followed by further development and a testing stage of e-SiP that involved the coding of a prototype, which was then evaluated using a series of steering group meetings, semistructured interviews with both patients and health care professionals, and analysis of e-SiP log data. RESULTS: Feedback from focus groups and health professional interviews was very positive, and it was felt e-SiP use would support and encourage patients in conducting their swallowing exercises. However, of the 10 patients who were offered e-SiP, only 2 opted to use it. For these patients, the aspects of the e-SiP app were considered useful, in particular, the ease of keeping a diary of exercises performed. Interviews with users and nonusers suggested significant barriers to its use. Most significantly, the lack of flexibility of the platform on which e-SiP could be accessed appeared a dominant factor in deterring e-SiP use. CONCLUSIONS: The results suggest that further research needs to be conducted around the implementation of e-SiP. This involves evaluating how e-SiP can be better integrated into usual care and through patient training and staff engagement, can be perceived as a beneficial tool to help support patients in conducting swallowing exercises.

Improving the sustainability of hospital-based interventions: a study protocol for a systematic review.

INTRODUCTION: Sustaining effective interventions in hospital environments is essential to improving health outcomes, and reducing research waste. Current evidence suggests many interventions are not sustained beyond their initial delivery. The reason for this failure remains unclear. Increasingly research is employing theoretical frameworks and models to identify critical factors that influence the implementation of interventions. However, little is known about the value of these frameworks on sustainability. The aim of this review is to examine the evidence regarding the use of theoretical frameworks to maximise effective intervention sustainability in hospital-based settings in order to better understand their role in supporting long-term intervention use. METHODS AND ANALYSIS: Systematic review. We will systematically search the following databases: Medline, AMED, CINAHL, Embase and Cochrane Library (CENTRAL, CDSR, DARE, HTA). We will also hand search relevant journals and will check the bibliographies of all included studies. Language and date limitations will be applied. We will include empirical studies that have used a theoretical framework (or model) and have explicitly reported the sustainability of an intervention (or programme). One reviewer will remove obviously irrelevant titles. The remaining abstracts and full-text articles will be screened by two independent reviewers to determine their eligibility for inclusion. Disagreements will be resolved by discussion, and may involve a third reviewer if required. Key study characteristics will be extracted (study design, population demographics, setting, evidence of sustained change, use of theoretical frameworks and any barriers or facilitators data reported) by one reviewer and cross-checked by another reviewer. Descriptive data will be tabulated within evidence tables, and key findings will be brought together within a narrative synthesis. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data will be collected. Dissemination of results will be through peer-reviewed journal publications, presentation at an international conference and social media. PROSPERO REGISTRATION NUMBER: CRD42017081992.

Evaluation of a Digital Consultation and Self-Care Advice Tool in Primary Care: A Multi-Methods Study.

Digital services are often regarded as a solution to the growing demands on primary care services. Provision of a tool offering advice to support self-management as well as the ability to digitally consult with a General Practitioner (GP) has the potential to alleviate some of the pressure on primary care. This paper reports on a Phase II, 6-month evaluation of eConsult, a web-based triage and consultation system that was piloted across 11 GP practices across Scotland. Through a multi-method approach the evaluation explored eConsult use across practices, exposing both barriers and facilitators to its adoption. Findings suggest that expectations that eConsult would offer an additional and alternative method of accessing GP services were largely met. However, there is less certainty that it has fulfilled expectations of promoting self-help. In addition, low uptake meant that evaluation of current effectiveness was difficult for practices to quantify. The presence of an eConsult champion(s) within the practice was seen to be a significant factor in ensuring successful integration of the tool. A lack of patient and staff engagement, insufficient support and lack of protocols around processes were seen as barriers to its success.

The Use of Facebook Advertising to Recruit Healthy Elderly People for a Clinical Trial: Baseline Metrics.

BACKGROUND: This report provides data on the use of social media advertising as a clinical trial recruitment strategy targeting healthy volunteers aged 60 years and older. The social media advertising campaign focused on enrollment for a Phase 1 clinical trial. Traditional means of recruiting-billboards, newspaper advertising, word of mouth, personal referrals, and direct mail-were not producing enough qualified participants. OBJECTIVE: To demonstrate the effectiveness of using targeted advertising on the social networking site Facebook to recruit people aged 60 years and older for volunteer clinical trial participation. METHODS: The trial sponsor used a proactive approach to recruit participants using advertising on social media. The sponsor placed and monitored an Institutional Review Board-approved advertising campaign on Facebook to recruit potential candidates for a Phase 1 clinical trial. The clinical trial required a 10-day residential (overnight) stay at a clinic in Michigan, with one follow-up visit. The sponsor of the clinical trial placed the advertising, which directed interested respondents to a trial-specific landing page controlled by the Contract Research Organization (CRO). The CRO provided all follow-up consenting, prescreening, screening, and enrollment procedures. The campaign was waged over an 8-week period to supplement recruiting by the CRO. RESULTS: A total of 621 people responded to a Facebook advertising campaign by completing an online form or telephoning the CRO, and the clinical trial was fully enrolled at 45 subjects following an 8-week Facebook advertising campaign. CONCLUSIONS: An 8-week Facebook advertising campaign contributed to 868 inquiries made regarding a Phase 1 clinical trial seeking to enroll healthy elderly subjects. Over the initial 11 weeks of recruitment, 178 inquiries were received using traditional methods of outreach. Respondents to the Facebook advertising campaign described in this report engaged with the sponsored advertising at a higher rate than is typical for social media-based clinical trial recruitment strategies. The older adults' engagement rate of 4.92% was more than twice as high as click-through rates of younger adults engaged with social media advertising in other clinical trial recruitment studies. Advertising placed on the social media platform Facebook is effective with the healthy volunteer population aged 60 years and older. This approach can quickly and cost-effectively reach qualified candidates for clinical trial recruitment as a supplement to traditional means of recruiting. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02840279; https://clinicaltrials.gov/ct2/show/NCT02840279 (Archived by WebCite at http://www.webcitation.org/6wamIWXAt).

Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery.

BACKGROUND: Few studies explore stroke survivor views and motivations towards stem cell therapy (SCT). This qualitative study explores the views and motivations of both stroke survivors and their partners/carers towards a proposed 2-arm Phase III Randomised Controlled Trial (RCT) comparing intracerebral insertion of stem cells with placebo neurosurgery in stroke survivors with disability. OBJECTIVE: To explore views and motivations towards a proposed 2-arm stem cell trial and identify factors that may impede and enhance participation. DESIGN: This study adopts a naturalistic design to explore the complexity of this field, employing a participatory action-research approach comprising a specialized Conversation (World) Café form of focus group. Data were collected via 5 Conversation Cafés with stroke survivors (age 40-75) and partners/carers between June and October 2016. Of 66 participants, 53 (31 male, 22 female) were stroke survivors and 13 (6 female, 7 male) were partners/carers. Qualitative data were analysed using a thematic approach. DISCUSSION AND CONCLUSION: Stroke survivor views and motivations reflect anticipation of the personal and future benefits of regenerative medicine. Partners/carers sought to balance the value of stroke survivor hope with carrying the weight of hope as carer, a conflict burden adding to known caregiver burden. All participants expressed the need for during and post-trial psychological support. This study provides a rare opportunity to explore the prospective views and motivations of stroke survivors and their partners/carers towards a proposed Phase III 2-arm RCT. This adds weight to qualitative evidence exploring capacity, consent, decision making, perceptions of treatment risk and supports required for clinical trial participation.

Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer-the SiP study protocol.

BACKGROUND: Head and neck cancer (HNC) is the sixth most common cancer worldwide, and the functional, psychological and social consequences of HNC cancer and its treatment can be severe and chronic. Dysphagia (swallowing problems) affects up to two thirds of patients undergoing combined chemoradiotherapy. Recent reviews suggest that prophylactic swallowing exercises may improve a range of short- and long-term outcomes; however, the importance of psychological and behavioural factors on adherence to swallowing exercises has not been adequately studied. This study aims to develop and test the feasibility of a Swallowing intervention Package (SiP) designed in partnership with patients, speech and language therapists (SLTs) and other members of the head and neck multi-disciplinary team (MDT), for patients undergoing chemoradiotherapy (CRT) or radiotherapy (RT) for head and neck cancer. METHODS/DESIGN: This feasibility study uses quantitative and qualitative research methods, within a quasi-experimental design, to assess whether patients will tolerate and adhere to the SiP intervention, which aspects of the intervention can be implemented and which cannot, whether treatment fidelity can be achieved across different contexts, whether study processes and outcome measures will be feasible and acceptable and to what extent the intervention is likely to have an impact on swallowing dysfunction and quality of life. Patients are being recruited from five sites in Scotland and England (three interventions and two usual care). The SLT based in the relevant intervention centre teaches the exercise programme and provides supporting materials. A combination of patient-reported outcome measures (PROMs), adherence measures and clinical swallowing assessments are used prior to intervention (baseline), at the end of treatment, 3 and 6 months post-treatment. DISCUSSION: This collaborative study has taken a unique approach to the development of a patient-centred and evidence-based swallowing intervention. The introduction of an e-SiP app provides an exploration of the use of technology in delivering this intervention. The study provides an opportunity to examine the feasibility of delivering and participating in a supported swallowing intervention across several different NHS sites and will provide the evidence needed to refine intervention and study processes for a future trial. TRIAL REGISTRATION: NCRI portfolio, 18192 & 20259.

Development and preliminary psychometric properties of the Care Experience Feedback Improvement Tool (CEFIT).

OBJECTIVE: To develop a structurally valid and reliable, yet brief measure of patient experience of hospital quality of care, the Care Experience Feedback Improvement Tool (CEFIT). Also, to examine aspects of utility of CEFIT. BACKGROUND: Measuring quality improvement at the clinical interface has become a necessary component of healthcare measurement and improvement plans, but the effectiveness of measuring such complexity is dependent on the purpose and utility of the instrument used. METHODS: CEFIT was designed from a theoretical model, derived from the literature and a content validity index (CVI) procedure. A telephone population surveyed 802 eligible participants (healthcare experience within the previous 12 months) to complete CEFIT. Internal consistency reliability was tested using Cronbach's α. Principal component analysis was conducted to examine the factor structure and determine structural validity. Quality criteria were applied to judge aspects of utility. RESULTS: CVI found a statistically significant proportion of agreement between patient and practitioner experts for CEFIT construction. 802 eligible participants answered the CEFIT questions. Cronbach's α coefficient for internal consistency indicated high reliability (0.78). Interitem (question) total correlations (0.28-0.73) were used to establish the final instrument. Principal component analysis identified one factor accounting for 57.3% variance. Quality critique rated CEFIT as fair for content validity, excellent for structural validity, good for cost, poor for acceptability and good for educational impact. CONCLUSIONS: CEFIT offers a brief yet structurally sound measure of patient experience of quality of care. The briefness of the 5-item instrument arguably offers high utility in practice. Further studies are needed to explore the utility of CEFIT to provide a robust basis for feedback to local clinical teams and drive quality improvement in the provision of care experience for patients. Further development of aspects of utility is also required.