What helps or hinders intervention success in primary care? Qualitative findings with older adults and primary care practitioners during a feasibility study to address malnutrition risk

Background: In the UK, about 14% of community-dwelling adults aged 65 and over are estimated to be at risk of malnutrition. Screening older adults in primary care and treating those identified as ‘at risk’ may help reduce malnutrition risk and associated healthcare use, and improve quality of life. The aim of this study is to explore how primary care practitioners (PCPs) and older adults perceive, use and respond to an intervention to support those identified as ‘at risk’. Methods: We developed and optimised an intervention (screen and treat protocol, online tools and printed materials) to support primary care practitioners to identify malnutrition risk among older adults, and intervene where necessary. We recruited older adults (described as ‘patients’ here) taking part in a feasibility study, and carried out semi-structured interviews to assess PCPs’ and patients’ engagement with the intervention, and identify any contextual issues that supported or undermined their engagement. Results: Four themes were developed, encompassing patients’ and PCPs’ perceptions of undernutrition, study measures and appointments, constraints on PCPs’ enthusiasm to make a difference, and patients’ expectations of nutritional appointments. Key findings included patients commonly not accepting advice for undernutrition/malnutrition but welcoming support for their nutritional needs; checklists potentially distracting patients from recalling discussions about their nutritional needs; a tension between PCPs’ desire to recruit less-well patients and logistical difficulties in doing so; and patients compromising their nutritional needs to suit others. Conclusions: Diverse factors influence whether an intervention succeeds in primary care. PCPs learn about an intervention/study in different ways, vary in how they understand and accept its aims, and desire to make a difference to their patients. Patients bring perceptions and expectations about the study’s aims, coloured by their habits and preferences, prior experience of research and healthcare, and pressure from social expectations. Each aspect must be considered when developing a successful primary care intervention that is viewed as relevant and meaningful, and presented using language that aligns with participants’ values and goals. Our findings suggest that references to ‘malnutrition risk’ should be avoided in any patient-facing materials/interactions as participants do not accept or identify with this label

Sialic acid-binding immunoglobulin-like lectin (Sigelac)-15 is a rapidly internalised cell-surface antigen expressed by acute myeloid leukaemia cells.

Funder: )Sialic acid-binding immunoglobulin-like lectin (Siglec)-15 has recently been identified as a critical tumour checkpoint, augmenting the expression and function of programmed death-ligand 1. We raised a monoclonal antibody, A9E8, specific for Siglec-15 using phage display. A9E8 stained myeloid leukaemia cell lines and peripheral cluster of differentiation (CD)33+ blasts and CD34+ leukaemia stem cells from patients with acute myeloid leukaemia (AML). By contrast, there was minimal expression on healthy donor leucocytes or CD34+ stem cells from non-AML donors, suggesting targeting Siglec-15 may have significant therapeutic advantages over its fellow Siglec CD33. After binding, A9E8 was rapidly internalised (half-life of 180 s) into K562 cells. Antibodies to Siglec-15 therefore hold therapeutic potential for AML treatment

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial

Background The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. Methods A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. Results The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60–80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. Conclusion The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. Trial registration ISCTRN ISRCTN13404264. Registered on 10 October 2018

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk : Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial

Funding Information: The Support Through Mobile Messaging and Digital Health Technology for Diabetes research team acknowledges the support of the National Institute for Health Research (NIHR) through the Clinical Research Networks. AF, LT, and RR have received support from the NIHR Oxford Biomedical Research Centre. RH received support from the NIHR Collaboration for Leadership in Applied Health Research and Care and North Thames at Bart's Health National Health Service (NHS) Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. This paper presents independent research funded by the NIHR under its Program Grants for Applied Research as part of a wider program of work (RP-PG-1214-20003). The authors thank the personnel of the University of Oxford Primary Care and Vaccines Clinical Trials Collaborative for providing support in the conduct of the trial.Peer reviewedPublisher PD

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot) : results of a feasibility randomised trial

Funding Information: This publication presents independent research funded by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-1214–20003). AF and RR are supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre. DPF is supported by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215–20007). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. This research was funded in whole, or in part, by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-1214–20003). For the purpose of Open Access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. The SuMMiT-D research team acknowledges the support of the Primary Care Clinical Trials Unit and the National Institute for Health and Care Research Clinical Research Network (NIHR CRN). The authors would like to thank the Thames Valley and South Midlands, West Midlands, South West Peninsula and the Greater Manchester Clinical Research Networks and the participating general practices for help with recruitment. The funder had no role in the design, execution, analyses, interpretation of the data, or decision to submit results for this study.Peer reviewe

Planning and optimising a digital intervention to protect older adults' cognitive health.

BackgroundBy 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the theory-, evidence- and person-based development of 'Active Brains': a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults.MethodsDuring the initial planning phase, scoping reviews, consultation with PPI contributors and expert co-investigators and behavioural analysis collated and recorded evidence that was triangulated to inform provisional 'guiding principles' and an intervention logic model. The following optimisation phase involved qualitative think aloud and semi-structured interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes and additions to guiding principles, the behavioural analysis and the logic model which, in turn, informed changes to intervention content.ResultsScoping reviews and qualitative interviews suggested that the same intervention content may be suitable for individuals with higher and lower cognitive performance. Qualitative findings revealed that maintaining independence and enjoyment motivated engagement in intervention-targeted behaviours, whereas managing ill health was a potential barrier. Social support for engaging in such activities could provide motivation, but was not desirable for all. These findings informed development of intervention content and functionality that appeared highly acceptable amongst a sample of target users.ConclusionsA digitally delivered intervention with minimal support appears acceptable and potentially engaging to older adults with higher and lower levels of cognitive performance. As well as informing our own intervention development, insights obtained through this process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. OBJECTIVE: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. METHODS: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). RESULTS: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. CONCLUSIONS: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929

Abstracts from the NIHR INVOLVE Conference 2017

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Determination of eigensolutions of arbitrary matrices using simultaneous iteration accelerated by Jacobi-like methods

Imperial Users onl

The role (or not) of patients and the public in realist reviews

Today, patient and public involvement (PPI) in research activities – as contributors rather than participants – is an expected component of health-related studies [1]. Researchers are increasingly held to account for facilitating such involvement and for reporting it accurately in papers they write [2-3]. PPI has become commonplace in empirical, primary research, but it is less readily adopted within evidence synthesis. Evidence synthesis, an umbrella term for different approaches to combining existing literature, includes realist reviews. Realist reviews intend to explore what works, for whom and in what contexts, most commonly for a specific healthcare intervention or innovation [4]. Involving patients and the public within realist reviews has received much less attention than for other forms of evidence synthesis [5-6]. Having recently conducted a number of realist reviews, we reflected on PPI within these pieces of research. Two broad and important issues emerged - why are patient and public contributors being involved and how? We recognised that the need for and purpose of PPI differed between our reviews, as did the processes for involvement. Looking back across our reviews, we have generated the following prompts for researchers (see table 1) that would have been helpful to consider prior to the start of our realist reviews. These prompts have been iteratively developed by the research team with the help from two patient contributors involved in our reviews. We intend for these prompts to act as points of reflection for researchers doing realist reviews. These prompts remind researchers to clarify why and how they will involve patient and public contributors