A rapid evaluation of the implementation of Digital Social Care Records in England.

Health and Social Care Delivery Research (HSDR) Programme is part of the National Institute for Health and Care Research (NIHR). As such, it aims to contribute to the NIHR's mission of improving the health and wealth of the nation by funding evaluative research projects that have the potential to improve the quality, accessibility and organisation of health and social care services by providing useful outputs for decision-makers, staff, service users, academic, and public audiences. More information about the programme can be found on the NIHR website. A logic model is a visual way of showing how an activity, programme or intervention is expected to work and bring about the benefits and changes it intends to achieve. By summarising the core elements, a logic model can be used to support programme planning, implementation, and evaluation. NIHR logic models presentin a linear flow diagramthe key activities, outputs, outcomes and impacts of each funding programme as a series of logical steps.

Developing an International Core Outcome Set for SSD Interventions

To assess the effects of consumer engagement in health care policy, research and services. We updated a review published in 2006 and 2009 and revised the previous search strategies for key databases (The Cochrane Central Register of Controlled Trials; MEDLINE; EMBASE; PsycINFO; CINAHL; Web of Science) up to February 2020. Selection criteria included randomised controlled trials assessing consumer engagement in developing health care policy, research, or health services. The International Association for Public Participation, Spectrum of Public Participation was used to identify, describe, compare and analyse consumer engagement. Outcome measures were effects on people; effects on the policy/research/health care services; or process outcomes. We included 23 randomised controlled trials with a moderate or high risk of bias, involving 136,265 participants. Most consumer engagement strategies adopted a consultative approach during the development phase of interventions, targeted to health services. Based on four large cluster-randomised controlled trials, there is evidence that consumer engagement in the development and delivery of health services to enhance the care of pregnant women results in a reduction in neonatal, but not maternal, mortality. From other trials, there is evidence that involving consumers in developing patient information material results in material that is more relevant, readable and understandable for patients, and can improve knowledge. Mixed effects are reported of consumer-engagement on the development and/or implementation of health professional training. There is some evidence that using consumer interviewers instead of staff in satisfaction surveys can have a small influence on the results. There is some evidence that consumers may have a role in identifying a broader range of health care priorities that are complementary to those from professionals. There is some evidence that consumer engagement in monitoring and evaluating health services may impact perceptions of patient safety or quality of life. There is growing evidence from randomised controlled trials of the effects of consumer engagement on the relevance and positive outcomes of health policy, research and services. Health care consumers, providers, researchers and funders should continue to employ evidence-informed consumer engagement in their jurisdictions, with embedded evaluation.Systematic review registration: PROSPERO CRD42018102595.

To assess the effects of consumer engagement in health care policy, research and services. We updated a review published in 2006 and 2009 and revised the previous search strategies for key databases (The Cochrane Central Register of Controlled Trials; MEDLINE; EMBASE; PsycINFO; CINAHL; Web of Science) up to February 2020. Selection criteria included randomised controlled trials assessing consumer engagement in developing health care policy, research, or health services. The International Association for Public Participation, Spectrum of Public Participation was used to identify, describe, compare and analyse consumer engagement. Outcome measures were effects on people; effects on the policy/research/health care services; or process outcomes. We included 23 randomised controlled trials with a moderate or high risk of bias, involving 136,265 participants. Most consumer engagement strategies adopted a consultative approach during the development phase of interventions, targeted to health services. Based on four large cluster-randomised controlled trials, there is evidence that consumer engagement in the development and delivery of health services to enhance the care of pregnant women results in a reduction in neonatal, but not maternal, mortality. From other trials, there is evidence that involving consumers in developing patient information material results in material that is more relevant, readable and understandable for patients, and can improve knowledge. Mixed effects are reported of consumer-engagement on the development and/or implementation of health professional training. There is some evidence that using consumer interviewers instead of staff in satisfaction surveys can have a small influence on the results. There is some evidence that consumers may have a role in identifying a broader range of health care priorities that are complementary to those from professionals. There is some evidence that consumer engagement in monitoring and evaluating health services may impact perceptions of patient safety or quality of life. There is growing evidence from randomised controlled trials of the effects of consumer engagement on the relevance and positive outcomes of health policy, research and services. Health care consumers, providers, researchers and funders should continue to employ evidence-informed consumer engagement in their jurisdictions, with embedded evaluation. Systematic review registration: PROSPERO CRD42018102595.

Will the new Health Research Authority (HRA) framework go far enough? Dr Emily Phipps, Professor Sian Griffiths of The Chinese University of Hong Kong, and Dr Mark Sheehan of the Nuffield Department of Population Health, Oxford University, consider the challenges facing the new HRA framework in addressing research into public health interventions on both an individual and a population level.IntroductionIn 2013, the public health functions of the National Health Service (NHS) in England moved to local government as part of reforms under the Health and Social Care Act 2012.[1] In this setting, the public health team commissions and manages a broad portfolio of programmes that aim to positively influence the local population's health and wellbeing, reduce inequalities and promote a healthy lifestyle.[2] The very nature of this work requires public health interventions to span the functions of health and politics, bringing together expertise from clinical, nursing, social care and local government backgrounds.Developing a robust evidence base for the delivery of public health interventions is key to ensuring that public health teams can provide the most effective and efficient service possible. Research governance processes regulate the design, implementation and dissemination of studies into public health interventions and are a legal requirement of health research conducted in England. However, there is currently significant variation in the quality and accessibility of research governance processes in local authorities in England to support the study of public health interventions.[1] In a recent nationwide study by Rainey et al.,[3] 35% of research governance leads listed on a national local authority database were no longer in post, and 25% of respondents from local authority public health and social care teams reported not having or not being aware of research governance arrangements in their local authority.Where such processes are available, a lack of familiarity with the relatively recently introduced public health functions to local authority can make it difficult for research projects to be assessed in a robust and appropriate manner. Research governance leads unfamiliar with governance issues pertinent to the study of public health interventions may be reluctant to pass review and approval. This risk may mean that projects are altered at the point of design to 'fit' the model most familiar to the research governance lead, rather than being of a methodology best suited to the hypothesis in question, in order to increase the likelihood of approval.Ethical review processes are a fundamental part of research governance, protecting the safety, dignity, rights and wellbeing of study participants. Researchers wishing to study public health interventions in local authorities rely on there being robust and appropriate ethical review services available in that organisation. As the nature of this research is unlikely to involve conventional methodology or typically medical interventions, local NHS research governance teams will likely not feel appropriately equipped to provide approval. In addition, academic research ethics committees often will not review the ethics of applications for research that is being conducted without university involvement, and vary widely in their approval processes and remit.[4] National guidance on the provision of research governance services, such as ethical review processes within local authority settings in England, may be one way to ensure standardised and appropriate services are available.In January 2015, the Health Research Authority (HRA) took over the responsibilities of the National Research Ethics Service and National Social Care Research Ethics Committee, so that all research involving health and social care in England is now governed by the same authority. The HRA are currently developing a high-level framework to guide the revision of local research governance policy which should recognise the changes to health and social care functions introduced in 2012. …

Background People living with multiple long-term conditions represent a significant concern for National Health Service policy and practice, and their care is a major theme in the 2019 National Health Service Long Term Plan. The Birmingham RAND and Cambridge Rapid Evaluation Centre team has undertaken a thematic synthesis of the 10 evaluations it has conducted from 2018 to 2023, exploring the needs, priorities and implications for people with multiple long-term conditions. Objectives The aims for this overarching study were to: (1) build a body of learning about service innovations in primary and community settings for people of all ages with multiple long-term conditions, focused on questions that matter most to people with multimorbidity; and (2) develop methodological insights about how rapid evaluation can be used to inform the scoping, testing and implementation of service innovations for people with multiple long-term conditions. Design The focus on multiple long-term conditions came from a Birmingham RAND and Cambridge Rapid Evaluation Centre prioritisation process undertaken in 2018 using James Lind Alliance methods. Cross-analysis of the findings from the 10 individual rapid evaluations was supplemented by (1) building aspects of multimorbidity into the design of later evaluations; (2) interviewing national and regional stakeholders (n=19) working in or alongside integrated care systems; (3) undertaking a rapid review of evidence on remote monitoring for people with multiple long-term conditions (19 papers included); and (4) testing overall insights with organisations representing patients and carers through a patient, public and professional engagement workshop with 10 participants plus members of the research team. Results While living with multiple long-term conditions is common and is the norm for people over the age of 50 using health and care services, it is not often a focus of health service provision or innovation, nor of research and evaluation activity. We discuss six themes emerging from the totality of the study: (1) our health system is mainly organised around single conditions and not multiple long-term conditions; (2) research calls and studies usually focus on single conditions and associated services; (3) building opportunities for engaged, informed individuals and carers and improved self-management; (4) the importance of measures that matter for patients and carers; (5) barriers to developing and implementing service innovations for people with multiple long-term conditions; and (6) what is needed to make patients with multiple long-term conditions a priority in healthcare planning and delivery. Limitations Care of people with multiple long-term conditions was not the principal focus of several of the rapid evaluations. While this was a finding in itself, it limited our learning about designing and implementing, as well as methodological approaches to evaluating, service innovations for people with multiple long-term conditions. Conclusions Through a thematic analysis of the portfolio of evaluations, we have deduced a set of suggested implications for how the needs of people with multiple long-term conditions can be better embedded in policy, research and practice. Future work Areas of uncertainty related to the care of people with multiple long-term conditions should be further explored, including developing and testing measures of patient experience of (un)co-ordinated care across settings, and interrogating the experience of health and care staff when working with people with multiple long-term conditions, to understand what works. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR134284) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 15. See the NIHR Funding and Awards website for further award information.

Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. 90146150 (28/03/2019).

IntroductionPolypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting.MethodsThis trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care.Ethics and disseminationThe protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers.ISRCTN Registration90146150 (28/03/2019)

Introduction: Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. Methods: This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. Ethics and dissemination: The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. ISRCTN Registration: 90146150 (28/03/2019)

Significant advances in systemic therapy have improved survival for patients with advanced-stage non-small cell lung cancer (NSCLC). However, the present treatment strategies and dose-fractionation for high-dose palliative radiotherapy (RT) are based on trials from the 1990s, when RT planning was simple with less precise delivery. Contemporary lung RT uses 4D-CT, volumetric modulated arc radiotherapy, aided by online verification using cone beam CT, which enables greater accuracy and better target volume coverage, while reducing doses to normal organs at risk. The Shortened High-dose Palliative Radiotherapy for Lung Cancer study aims to evaluate the safety and feasibility of reducing the number of RT fractions and RT duration, using contemporary planning, verification and delivery techniques. This single-arm, multicentre, phase-II study will test the shortened hypofractionated accelerated palliative RT regimen of 30 Gy in 6 alternate-day fractions, with strict normal tissue dose constraints. We aim to recruit 37 patients across 4 sites within the West Midlands. Quality assurance for the RT is supported by the Radiotherapy Trials Quality Assurance Group (RTTQA). Patients with locally advanced or metastatic NSCLC, who are candidates for high-dose palliative RT, before or after first-line systemic therapy, are eligible for recruitment. The primary objective of this study is to assess the safety of the proposed dose-fractionation. Secondary objectives include evaluating toxicity profiles, patient-reported outcome measures, time to progression, feasibility and the National Health Service cost-saving. This study is conducted in accordance with the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines and all applicable regulatory frameworks, including, but not limited to, the UK policy framework for health and social care research, as well as the Health Research Authority and Health and Care Research Wales regulations. Approval for the study was granted on 18 April 2024 (IRAS project ID: 332998; REC reference: 24/WM/0032). The chief investigator is responsible for obtaining informed consent from participants. Any individual delegated this responsibility is thoroughly authorised, trained and competent to conduct the informed consent process. On completion of the trial, the results will be shared with participants in a plain language summary and will be submitted for publication in a peer-reviewed journal. If successful, this study will inform a phase III randomised controlled trial to assess efficacy. For updates on the study, visit the study web page (https://research.mededcoventry.org/About-Us/Meet-The-Team/TMU/Ship-Rt). NCT06483308.

. As such, it aims to contribute to the NIHR's mission of improving the health and wealth of the nation by funding research that assesses the clinical and cost-effectiveness of healthcare treatments in comparison with the current best alternative(s), and that is therefore immediately useful to patients, clinical practice, and policy or decision-makers. More information about the programme can be found on the NIHR website. A logic model is a visual way of showing how an activity, programme or intervention is expected to work and bring about the benefits and changes it intends to achieve. By summarising the core elements, a logic model can be used to support programme planning, implementation and evaluation. NIHR logic models representin a linear flow diagramthe key activities, outputs, outcomes and impacts of each funding programme as a series of logical steps.

The NHS: what are the UK's political parties promising?

Introduction: Cancer-related fatigue is well described. Fatigue in patients with a malignant pleural effusion (MPE) has not been directly studied. Methods: A prospective observational cohort pilot study ‘Do Interventions for Malignant Pleural Effusions (MPE) impact on patient reported fatigue levels (IMPE-F study)’ is planned to determine whether pleural interventions reduce fatigue in MPE. Fatigue will be assessed with a validated patient reported outcome measure, FACIT-F. Discussion: MPE-F has funding from Rocket Medical Plc, and is part of a Masters in Clinical Research at Newcastle University. Respondent fatigue will be addressed by the investigators going through the questionnaire with the participants. Inclusion criteria are all patients above 18 years of age with a presumed MPE undergoing a procedure and able to consent. The expected number of participants is 50. Trial registration: The IMPE-F study has Research Ethics Committee (REC) [20/YH/0224] and Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approvals [IRAS project ID: 276451]. The study has been adopted on National Institute for Health Research portfolio [CPMS ID 46430].

Early delayed gastric emptying (DGE) occurs in up to 37% of patients following esophagectomy. This can contribute to increased anastomotic leak and respiratory infection rates. Although the treatment of DGE in the form of pyloric balloon dilatation (PBD) post-operatively is well established, there is no consensus on the optimal approach in the prevention of DGE. The aim is to carry out a randomised control trial to determine the efficacy of prophylactic PBD in the prevention of DGE following esophagectomy. This presentation details the protocol, recruitment strategy and potential timeline for a feasibility study addressing this. We detail the rationale, objectives, design, and methods of this study. Patients will be recruited over a three to six-month period (starting in January 2022) and randomised to either a control group (no intervention) or a treatment group (prophylactic PBD). The Chief Investigator has obtained approval from the UK Health Research Authority (HRA) and Research Ethics Committee (REC) on 01/12/21 (IRAS project ID: 287659). As a feasibility study, the objectives will be to ascertain the following: Number of patients approached; Number of patients who agreed to be randomised; Number of patients successfully randomised; Number of patients who dropped out; Successful measurement of outcome measures (delayed gastric emptying, pneumonia, anastomotic leak). Prophylactic pyloric balloon dilatation is potentially a safe and effective procedure which can significantly improve outcomes in patients after an esophagectomy. This protocol describes details for the feasibility study to be carried out which will allow important learning points for the main randomised controlled trial.

Evaluation of the National Institute for Health and Care Research’s (NIHR) Global Health Research (GHR) Portfolio - Inception Report