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Developing theoretically grounded strategies to enable and promote patient and public involvement in implementation research studies
Full text linkImplementation research has emerged as a branch of healthcare research. It studies methods to promote the application of research findings into practice, and, thus, to improve the quality and effectiveness of services and care. Patient and public involvement (PPI) in implementation research is a means of bridging research and practice. However, the progress to achieve greater involvement is slow. The reasons might include potential tensions when including perspectives of stakeholders with diverse skills, backgrounds and experiences, and the risk of reproducing paternalistic clinician-patient relationship tradition of healthcare research, which is incompatible with PPI.
In this commentary we shared the PPI navigation approach that we used in a recent implementation research project, where eight patient and public partners attended three 1-hour sessions to discuss a specific implementation research methodology. On reflection, we categorised the approach into three strategies that aimed to empower patient and public partners and promote their senses of autonomy, relatedness and competence. According to the Basic Psychological Needs Theory, these are principal human needs, fulfilment of which may lead to higher motivation, performance, and well-being. We outlined the process of applying each strategy and used this and other theories to show why this can lead to positive partner and research outcomes. Two patient and public partners provided their perspectives about what worked and what could be further improved. The strategies can be used in future implementation studies, and we provide recommendations for the development of more strategies using the theory-based approach
Validation of salivary uric acid remote self-monitoring for early prediction of hypertensive disorders of pregnancy: study protocol for a prospective, observational, multicentre cohort study
Full text linkIntroduction
Hypertensive disorders of pregnancy (HDP), including gestational hypertension and pre-eclampsia, affect approximately 10% of pregnancies worldwide and contribute significantly to fetal and maternal morbidity and mortality. Early identification of HDP would facilitate targeted surveillance and personalised care in order to mitigate the severity of complications and improve pregnancy outcomes. Uric acid is a marker of oxidative stress, inflammation and endothelial dysfunction, and has been proposed as a predictor of hypertensive disease. Salurate is a salivary uric acid test that has the potential to identify pregnant women at risk of developing HDP several weeks before clinical manifestation.
Methods and analysis
This is a prospective, multicentre, observational, cohort study with health economics evaluation. Women aged 16 and above, with a viable singleton pregnancy at <16 weeks gestation and a combined first trimester pre-eclampsia risk of >1:300 will be eligible for recruitment. Participants will perform weekly remote salivary uric acid testing from enrolment until the conclusion of pregnancy and upload results of colourimetric paper tests via a smartphone application. We will validate a predictive algorithm that analyses colour data from several consecutive samples to detect patterns that predict whether HDP is likely to occur. The primary outcome is test performance for the prediction of HDP. Secondary outcomes include adherence to sampling and test performance for predicting gestational diabetes, stillbirth and fetal growth restriction. Data on pregnancy outcomes will be collected from the medical notes, compared with the predictions made by the algorithm and subjected to statistical analysis.
Ethics and dissemination
Approval has been obtained from Cambridge East Research Ethics Committee (REC reference 24/EE/0123), Medicines and Healthcare products Regulatory Agency (CI/2024/0038/GB) and Health Research Authority (IRAS ID 337290). Results of the study will be published in peer-reviewed journals and presented at national and international conferences.
Trial registration number
ISRCTN17992452.
Protocol version
4, 4 July 2024
Magnetic resonance enterography to predict subsequent disabling Crohn’s disease in newly diagnosed patients (METRIC-EF)—multivariable prediction model, multicentre diagnostic inception cohort
Full text linkObjectives
Magnetic resonance enterography (MRE) is a first-line investigation to diagnose Crohn’s disease (CD), but its role for prognostication is unknown. Accordingly, we assessed the predictive ability of prognostic models including MRE scores (MRE Global Score (MEGS), simplified MR Index of Activity (sMARIA), and Lémann index (LI)) against models using clinical predictors alone for the development of modified Beaugerie disabling CD (MBDD) within 5 years of diagnosis.
Methods
This was a multicentre, diagnostic inception cohort of patients with newly diagnosed CD across 9 UK hospitals, followed for 4 years or more. We censored development of MBDD ≤ 90 days from diagnosis, and used time-to-event models using Royston-Parmer flexible parametric models.
Results
We included 194 patients, median age 29, IQR 22–44 years, 52% female. Within 5 years of diagnosis, 42% (81/194) developed MBDD. In univariable analysis, initial steroid requirement was associated with increased risk of developing MBDD (HR 2.11 (95% CI 1.36, 3.26). The baseline clinical model had 49% (39, 60) sensitivity and 66% (57, 74) specificity for predicting the top 40% of patients with the greatest risk of developing MBDD, and 86% (77, 92) sensitivity and 35% (27, 45) specificity for predicting the development of MBDD in patients with an absolute risk of ≥ 10%. There was no significant difference in sensitivity when the MEGS, sMARIA, or LI were added to the baseline clinical model.
Conclusions
Addition of MRE scores at diagnosis to a multivariable model comprising clinical predictors did not improve prediction of MBDD within 5 years of diagnosis.
Key Points
Question
Magnetic resonance enterography (MRE) is important for diagnosing and monitoring Crohn’s disease (CD), but primary research evaluating its prognostic role is lacking.
Findings
Adding MRE findings at diagnosis to a multivariable model comprising clinical predictors did not improve the prediction of disabling CD within 5 years of diagnosis.
Clinical relevance
When tested in a prospective, multicentre trial, current MRE activity and damage scores at diagnosis did not reliably predict whether patients would subsequently develop disabling CD. Notwithstanding this finding, MRE remains an essential tool for diagnosis and monitoring
Co-designing and testing a management programme with peer support for post-stroke fatigue: Nottingham fatigue after stroke study (NotFAST3)
Full text linkObjective
To develop and test a novel programme to support post-stroke fatigue management for testing in a future clinical trial.
Design
Staged approach to development and preliminary testing. Phases 1 and 2: co-design groups held to agree programme content and resources. Phase 3: training for facilitators developed and delivered. Phase 4: feasibility of programme delivery tested with questionnaires completed at beginning and end, and feedback interviews conducted.
Setting
Community, online.
Participants
Stroke survivors with post-stroke fatigue, carers and healthcare professionals.
Intervention
Post-stroke fatigue management programme supported by ‘buddies’ with lived or professional experience of managing fatigue.
Main measures
In phase 4, we examined feasibility of programme delivery (recruitment, retention, engagement and acceptability) and preliminary signals of efficacy.
Results
In phases 1 and 2 we recruited 23 participants (16 stroke survivors, 2 carers and 5 healthcare professionals) and designed resources. In phase 3, 10 people supported training development: 7 received training to be buddies. In phase 4 we recruited 15 people with fatigue; 13 completed the programme. Of these, 13 completed baseline and 12 follow-up questionnaires. All buddies (7/7) and 12/13 participants were interviewed. Mean number of sessions delivered was 9 (SD 3.24; range 3–13) and ranged from 10 to 60 minutes (mean 28 minutes; SD 10.04). Overall, mean fatigue severity reduced, activity increased, and mood measures improved. Participants and buddies were positive about the programme and believed it was worthwhile.
Conclusions
The programme was acceptable and feasible, with preliminary evidence of efficacy, but some issues need to be addressed in future trial design
The unexploited potential of data systems tracking medicines utilization: an opportunity to improve access to oncology combination therapies
Full text linkBackground: While progress has been made in oncology treatments, including the introduction of combination therapies, barriers affect patient access. There are approaches that could improve access including combination-specific pricing that allow the price to reflect whether a product is used in monotherapy or in combination. The feasibility of this solution requires data on the utilization of combination therapies.
Aim: To investigate the ability of data systems across Belgium, England, France, Italy, Spain, Sweden, Switzerland and Australia to track drug utilization of combination therapies, particularly in oncology.
Methods: A targeted literature review was conducted to investigate the attributes of the key data systems. One-on-one semi-structured interviews were subsequently conducted with country experts to validate the research, who were screened based on their expertise and knowledge of the respective data and reimbursement systems in their countries, followed by an advisory board to align on policy recommendations. Country-specific and cross-border insights were gathered from nine experts across these countries.
Results: There are data systems that routinely collect medicine utilization data across seven European countries and Australia. These datasets can potentially be leveraged to track the utilization of combination therapies. Where available, administrative data systems, such as reimbursement claims data, can be leveraged, though other types of systems, such as product registries, may be more suitable in some countries, emphasizing the need to consider country-specific nuances. Using existing data systems is likely to be less resource-intensive than setting up a novel system for this application. While viable sources of data exist in most countries, many need improving to fully harness their tracking potential. There are several common areas where improvement is needed to track combination therapies effectively. These include data quality, access for different stakeholders, minimizing the burden of data entry and management, and increasing support from national authorities to foster multi-stakeholder engagement.
Conclusion: While most countries possess data systems that could serve as a foundation for tracking combination oncology therapies, these systems require optimization and proper implementation. Our core recommendation is for policymakers to explore the expansion and enhancement of data infrastructures
Strategies to enhance recruitment of female participants to cardiovascular research: a joint British Cardiovascular Societies’ consensus document in collaboration with the British Heart Foundation Clinical Research Collaborative
Full text linkDespite significant progress in cardiovascular pharmacotherapy and interventional strategies, cardiovascular disease (CVD) remains the leading cause of morbidity and mortality among females in the UK and worldwide. This might be due to lack of robust evidence in the best care of females with CVD related to under-representation of females in clinical trials (females accounting for <30% of trial participants). Recently, the British Cardiovascular Society (BCS), together with the affiliated societies, put together a consensus document specifically describing the current status on the sex differences in each of the major disease areas and proposed strategies/actionable points to overcome the barriers in access to diagnosis and treatment of CVD among females.
In order to address the disparities, several research organisations, including the UK National Institute for Health and Care Research (NIHR), have produced guidance to diversify research participation and representation. The UK government has developed a Women’s Health Strategy for England. In the present consensus, we evaluate the barriers to research participation of female participants across the CVD spectrum and describe specific strategies/actionable points to enhance female involvement in clinical cardiovascular research. It is hoped that this document will stimulate a multifaceted approach to address disparities, including raising awareness and undertaking sex/gender-based research. We aim to improve the current status of management in various disease areas among females by collaboration across different affiliations within the BCS, the British Heart Foundation Clinical Research Collaborative and the NIHR to collectively work towards improving the health and well-being of females with CVD
Development and validation of a Jordan-specific risk score for type 2 diabetes mellitus
Full text linkBackground
Jordan has a high prevalence of type 2 diabetes mellitus (T2DM), but it is estimated that nearly half of all cases in the Middle East and North Africa region remain undiagnosed. This study aimed to develop, validate and assess the diagnostic performance of a diabetes risk score to identify Jordanians at high risk of T2DM.
Methods
Random samples of 5000 Jordanians aged 20–79 years were simulated at different time points using an existing mathematical model describing T2DM epidemiology in Jordan. The risk score was derived through logistic regression applied to the simulated samples, using age, sex, obesity, smoking and physical inactivity as predictive variables. Cut-off values were determined based on the maximum sum of sensitivity and specificity.
Results
In 2020, the estimated area under the curve (AUC), sensitivity and specificity of the derived Jordan Diabetes Risk Score were 0.79 (95% CI: 0.77 to 0.80), 78.7% (95% CI: 77.5 to 79.8%) and 64.2% (95% CI: 62.9 to 65.6%), respectively. The positive and negative predictive values were 29.7% (95% CI: 28.4 to 31.0%) and 94.0% (95% CI: 93.3 to 94.7%), with 42.7% of Jordanians at high risk for diabetes. Similar diagnostic metrics were observed for the 2030 and 2050 risk scores, with AUCs of 0.78 (95% CI: 0.77 to 0.80) and 0.77 (95% CI: 0.76 to 0.79), respectively. The performance of the derived model-based score was comparable to a survey-based score and demonstrated better performance within the Jordanian population compared with existing regional and international scores.
Conclusions
The Jordan Diabetes Risk Score demonstrated strong diagnostic performance, offering an effective, non-invasive and accessible tool for diabetes screening. This tool can facilitate early detection, timely intervention and increased awareness, ultimately aiming to reduce the burden of T2DM and its complications in Jordan
UK Longitudinal Linkage Collaboration (UK LLC): The National Trusted Research Environment for Longitudinal Research
Full text linkIntroduction
The UK Longitudinal Linkage Collaboration (UK LLC) is the national Trusted Research Environment (TRE) for the UK's longitudinal research community, supporting the UK's unparalleled collection of Longitudinal Population Studies (LPS). Initially set up as a COVID-19 research resource, UK LLC is now a generic database for any research for the public good.
Objectives
UK LLC supports longitudinal research by providing record linkage and TRE services.
Methods The UK LLC partnership provides a secure analytics environment, a trusted third-party linkage processor and a comprehensive governance framework to minimise risks to participant confidentiality. UK LLC is ISO 27001 certified and accredited by the UK Statistics Authority as a processor under the Digital Economy Act. The active involvement by members of UK LLC's public involvement programme ensures UK LLC is acceptable to LPS participants and the wider public. All UK LPS are eligible for inclusion. Researchers can apply to access the TRE via an approach that fulfils the needs of the LPS, the linked data owners and includes a review by public contributors.
Results
Twenty-two LPS have so far joined UK LLC. Where permissions allow, participants are linked to their National Health Service (NHS) England, NHS Wales and place-based records, with work ongoing to link to NHS Scotland and non-health administrative records, including Department for Work and Pensions and His Majesty's (HM) Revenue and Customs. UK LLC Explore allows potential researchers to discover the breadth of data available in the TRE. All applications are listed on UK LLC's publicly accessible Data Access Register.
Conclusions
UK LLC enables researchers to interrogate pooled LPS participant data that are systematically linked to diverse records. UK LLC remains open to additional LPS joining the partnership and will increase the breadth of data to support the longitudinal research community and attract increasing numbers of researchers across multiple disciplines, government departments and industry
Behaviour change interventions to promote physical activity in people with intermittent claudication: the OPTIMA systematic review
Full text linkBackground
People with intermittent claudication are significantly less active compared to their peers without intermittent claudication, worsening future health outcomes. Supervised exercise therapy is not commonly available, but behaviour change techniques in unsupervised interventions can improve physical activity. Specific behaviour change techniques, theoretical mechanisms and contextual features linked to effectiveness remain unclear.
Objectives
To conduct an integrative synthesis of: effectiveness of behaviour change technique-based interventions on daily physical activity and clinical-/patient-reported outcomes; behaviour change techniques and theoretical mechanisms within effective behaviour change technique-based interventions; feasibility and acceptability. Primary outcomes: short term (< 6 months) and maintenance (> 6 months) of daily physical activity. Secondary outcomes: clinical-/patient-reported outcomes.
Data sources
Seven primary studies databases; Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, Health Technology Assessment Database and Trial Registers to 31 August 2023.
Review methods
Systematic review 1: interventions incorporating ≥ 1 behaviour change technique (coded using Behaviour Change Technique Taxonomy version 1, and Theoretical Domains Framework). Systematic review 2: quantitative, qualitative, mixed-methods research on patient/provider experiences. Study quality assessed using revised Cochrane risk-of-bias tool for randomised trials; Risk Of Bias In Non-randomised Studies – of Interventions and Mixed Methods Appraisal Tool.
Results
Fifty-three articles (41 studies) were included in systematic review 1, and 28 articles (28 studies) in systematic review 2. Eleven randomised controlled trials demonstrated that behaviour change technique-based interventions increased daily physical activity in the short term [increase of 0.20 standardised mean difference (95% confidence interval 0.07 to 0.33), ~ 473 steps/day] with high certainty. Evidence of maintenance of daily physical activity is unclear (increase of 0.12 standardised mean difference; ~ 288 steps/day). Behaviour change techniques aimed at improving patients’ intentions to engage in physical activity were most effective. Network analysis suggests that behaviour change technique-based interventions improved daily physical activity and may be better than supervised exercise therapy in maintaining daily physical activity. behaviour change technique-based interventions were acceptable and had short-medium-term benefits to initial/absolute claudication distance/time, walking impairment scores and disease-specific quality of life.
Conclusions
The behaviour change technique-based interventions are effective, targeting intention to engage in physical activity, in improving daily physical activity and functional outcomes in the short term, although evidence is limited for maintenance. There is a need for more randomised controlled trials examining daily physical activity and clinical outcomes, including longer-term follow-up, with detailed descriptions of behaviour change techniques, costs and provider views.
Study registration
This study is registered as PROSPERO CRD42020159869.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR130664) and is published in full in Health Technology Assessment; Vol. 29, No. 18. See the NIHR Funding and Awards website for further award information
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