scholarly journals Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033516 ◽  
Author(s):  
Edward Duncan ◽  
Alicia O'Cathain ◽  
Nikki Rousseau ◽  
Liz Croot ◽  
Katie Sworn ◽  
...  
Keyword(s):  
Health Research ◽  
Development Process ◽  
Public Involvement ◽  
Evidence Theory ◽  
Intervention Development ◽  
Target Population ◽  
Development Research ◽  
Qualitative Interview Study ◽  
The Uk ◽  
Delphi Studies

ObjectiveTo improve the quality and consistency of intervention development reporting in health research.DesignThis was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study.ParticipantsIntervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop.Resultse-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting.ConclusionsConsensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

scholarly journals Understanding successful development of complex health and healthcare interventions and its drivers from the perspective of developers and wider stakeholders: an international qualitative interview study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028756 ◽  
Author(s):  
Katrina M Turner ◽  
Nikki Rousseau ◽  
Liz Croot ◽  
Edward Duncan ◽  
Lucy Yardley ◽  
...  
Keyword(s):  
Real World ◽  
Development Process ◽  
Intervention Development ◽  
Grant Application ◽  
Successful Intervention ◽  
Qualitative Interview Study ◽  
Healthcare Interventions ◽  
Randomised Controlled ◽  
The Uk

ObjectiveIdentify how individuals involved in developing complex health and healthcare interventions (developers), and wider stakeholders in the endeavour, such as funders, define successful intervention development and what factors influence how interventions are developed.DesignIn-depth interviews with developers and wider stakeholders to explore their views and experiences of developing complex health and healthcare interventions.SettingInterviews conducted with individuals in the UK, Europe and North America.ParticipantsTwenty-one individuals were interviewed: 15 developers and 6 wider stakeholders. Seventeen participants were UK based.ResultsMost participants defined successful intervention development as a process that resulted in effective interventions that were relevant, acceptable and could be implemented in real-world contexts. Accounts also indicated that participants aimed to develop interventions that end users wanted, and to undertake a development process that was methodologically rigorous and provided research evidence for journal publications and future grant applications. Participants’ ambitions to develop interventions that had real-world impact drove them to consider the intervention’s feasibility and long-term sustainability early in the development process. However, this process was also driven by other factors: the realities of resource-limited health contexts; prespecified research funder priorities; a reluctance to deviate from grant application protocols to incorporate evidence and knowledge acquired during the development process; limited funding to develop interventions and the need for future randomised controlled trials (RCTs) to prove effectiveness. Participants expressed concern that these drivers discouraged long-term thinking and the development of innovative interventions, and prioritised evaluation over development and future implementation.ConclusionsTensions exist between developers’ goal of developing interventions that improve health in the real world, current funding structures, the limited resources within healthcare contexts, and the dominance of the RCT for evaluation of these interventions. There is a need to review funding processes and expectations of gold standard evaluation.

scholarly journals Working in partnership with communities to improve health and research outcomes. Comparisons and commonalities between the UK and South Africa

2019 ◽  
Vol 20 ◽  
Author(s):  
Patricia Wilson ◽  
Azwihangwisi Helen Mavhandu-Mudzusi
Keyword(s):  
South Africa ◽  
Health Care ◽  
Community Participation ◽  
South African ◽  
Health Research ◽  
Teenage Pregnancy ◽  
Public Involvement ◽  
Working Together ◽  
The Uk ◽  
Evaluation And Monitoring

Abstract Community and public participation and involvement is an underpinning principle of primary health care, an essential component of a social justice-orientated approach to health care and a vehicle to improving health outcomes for patients, public and communities. However, influenced by history and context, there are intrinsic issues surrounding power imbalance and other barriers to partnerships between communities, public, policy makers and researchers. It is important to acknowledge these issues, and through doing so share experiences and learn from those working within very different settings. In South Africa, community participation is seen as a route to decolonisation. It is also integral to the core functions of South African Higher Education Institutes, alongside teaching and research. In the UK, there has also been a history of participation and involvement as part of a social rights movement, but notably public involvement has become embedded in publicly funded health research as a policy imperative. In this paper, we draw on our respective programmes of work in public and community participation and involvement. These include a South African community engagement project to reduce teenage pregnancy and HIV infection working through a partnership between teachers, students and university academics, and a national evaluation in England of public involvement in applied health research. We begin by highlighting the lack of clarity and terms used interchangeably to describe participation, engagement and involvement. Frameworks for partnership working with relevance to South Africa and the UK are then analysed, suggesting key themes of relationships, working together, and evaluation and monitoring. The South African project and examples of public involvement in English primary and community care research are examined through these themes. We conclude the paper by mapping out common enablers and barriers to partnership working within these very different contexts.

scholarly journals Challenges and opportunities for involving patients and the public in acute antimicrobial medicine development research: an interview study

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024918 ◽  
Author(s):  
Andy Gibson ◽  
Michele Kok ◽  
David Evans ◽  
Sally Grier ◽  
Alasdair MacGowan
Keyword(s):  
Development Process ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Interview Study ◽  
Development Research ◽  
The Public ◽  
Principal Investigators ◽  
Development Life Cycle ◽  
Challenges And Opportunities ◽  
Potential Benefits

ObjectivesTo explore what approaches to patient and public involvement (PPI) in antimicrobial medicines development are currently being used, what the impacts of PPI are on antimicrobial medicines development and what the barriers are to its implementation.DesignInterview study.SettingAntimicrobial medicines development research.ParticipantsPrincipal investigators known to have led studies involving PPI or expressed an interest in PPI.ResultsThere is very little published work on PPI in antimicrobial research. Individual interviewees expressed scepticism about the contribution that PPI could make to different stages of the medicines development life cycle but collectively identified a range of potential benefits of PPI covering most stages of the medicines development process.ConclusionsA major issue in developing PPI in antimicrobial medicines development research will be in overcoming the view that, at best, PPI has only a marginal contribution to make in this area of research. The findings from this study, although mixed, suggest that well-designed PPI has an untapped potential to enhance antimicrobial research.

scholarly journals Optimising an intervention to support home-living older adults at risk of malnutrition: a qualitative study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Liz Payne ◽  
Daniela Ghio ◽  
Elisabeth Grey ◽  
Joanna Slodkowska-Barabasz ◽  
Philine Harris ◽  
...  
Keyword(s):  
Older Adults ◽  
At Risk ◽  
Public Involvement ◽  
Target Population ◽  
High Energy ◽  
Patient And Public Involvement ◽  
Community Dwelling ◽  
Good Nutrition ◽  
Intervention Content ◽  
The Uk

Abstract 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 at risk may help to reduce malnutrition risk, reduce the resulting need for healthcare use and improve quality of life. Interventions are needed to raise older adults’ risk awareness, offer relevant and meaningful strategies to address risk and support general practices to deliver treatment and support. Methods Using the Person-based Approach and input from Patient and Public Involvement representatives, we developed the ‘Eat well, feel well, stay well’ intervention. The intervention was optimised using qualitative data from think aloud and semi-structured process evaluation interviews with 23 and 18 older adults respectively. Positive and negative comments were extracted to inform rapid iterative modifications to support engagement with the intervention. Data were then analysed thematically and final adjustments made, to optimise the meaningfulness of the intervention for the target population. Results Participants’ comments were generally positive. This paper focuses predominantly on participants’ negative reactions, to illustrate the changes needed to ensure that intervention materials were optimally relevant and meaningful to older adults. Key factors that undermined engagement included: resistance to the recommended nutritional intake among those with reduced appetite or eating difficulties, particularly frequent eating and high energy options; reluctance to gain weight; and a perception that advice did not align with participants’ specific personal preferences and eating difficulties. We addressed these issues by adjusting the communication of eating goals to be more closely aligned with older adults’ beliefs about good nutrition, and acceptable and feasible eating patterns. We also adjusted the suggested tips and strategies to fit better with older adults’ everyday activities, values and beliefs. Conclusions Using iterative qualitative methods facilitated the identification of key behavioural and contextual elements that supported engagement, and issues that undermined older adults’ engagement with intervention content. This informed crucial revisions to the intervention content that enabled us to maximise the meaningfulness, relevance and feasibility of the key messages and suggested strategies to address malnutrition risk, and therefore optimise engagement with the intervention and the behavioural advice it provided.

scholarly journals Development of an Interactive Lifestyle Programme for Adolescents at Risk of Developing Type 2 Diabetes: PRE-STARt

Children ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. 69
Author(s):  
Deirdre M. Harrington ◽  
Emer M. Brady ◽  
Susann Weihrauch-Bluher ◽  
Charlotte L. Edwardson ◽  
Laura J. Gray ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
At Risk ◽  
Young People ◽  
Development Process ◽  
Intervention Development ◽  
Risk Groups ◽  
Stakeholder Input ◽  
Programme Content ◽  
The Uk

Background: Type 2 diabetes (T2D) is increasing in young people. Reporting on the processes used when developing prevention interventions is needed. We present the development of a family-based interactive lifestyle intervention for adolescents with risk factors for T2D in the future. Method: A multidisciplinary team in the UK site led the intervention development process with sites in Portugal, Greece, Germany and Spain. Potential programme topics and underpinning theory were gathered from literature and stakeholders. A theoretical framework based on self-efficacy theory and the COM-B (capability, opportunity, motivation, behaviour) model was developed. Sessions and supporting resources were developed and refined via two iterative cycles of session and resource piloting, feedback, reflection and refinement. Decision on delivery and content were made by stakeholders (young people, teachers, parents, paediatricians) and all sites. Materials were translated to local languages. Site-specific adaptations to the language, content and supporting resources were made. Results: The “PRE-STARt” programme is eight 90-min interactive sessions with supporting curriculum and resources. Iterative development work provided valuable feedback on programme content and delivery. Conclusion: Reporting on the intervention development process, which includes stakeholder input, could yield a flexible approach for use in this emerging ‘at risk’ groups and their families.

scholarly journals Shifting research culture to address the mismatch between where trials recruit and where populations with the most disease live: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tanvi Rai ◽  
Sharon Dixon ◽  
Sue Ziebland
Keyword(s):  
Capacity Building ◽  
Health Research ◽  
Active Sites ◽  
Public Involvement ◽  
Research Participation ◽  
Healthcare Services ◽  
Patient And Public Involvement ◽  
Research Activity ◽  
Set Up ◽  
The Uk

Abstract Background Research participation is beneficial to patients, clinicians and healthcare services. There is currently poor alignment between UK clinical research activity and local prevalence of disease. The National Institute of Health Research is keen to encourage chief investigators (CIs) to base their research activity in areas of high patient need, to support equity, efficiency and capacity building. We explored how CIs choose sites for their trials and suggest ways to encourage them to recruit from areas with the heaviest burden of disease. Methods Qualitative, semi-structured telephone interviews with a purposive sample of 30 CIs of ongoing or recently completed multi-centre trials, all of which were funded by the UK National Institute of Health Research. Results CIs want to deliver world-class trials to time and budget. Approaching newer, less research-active sites appears risky, potentially compromising trial success. CIs fear that funders may close the trial if recruitment (or retention) is low, with potential damage to their research reputation. We consider what might support a shift in CI behaviour. The availability of ‘heat maps’ showing the disparity between disease prevalence and current research activity will help to inform site selection. Embedded qualitative research during trial set up and early, appropriate patient and public involvement and engagement can provide useful insights for a more nuanced and inclusive approach to recruitment. Public sector funders could request more granularity in recruitment reports and incentivise research activity in areas of greater patient need. Accounts from the few CIs who had ‘broken the mould’ suggest that nurturing new sites can be very successful in terms of efficient recruitment and retention. Conclusion While improvements in equity and capacity building certainly matter to CIs, most are primarily motivated by their commitment to delivering successful trials. Highlighting the benefits to trial delivery is therefore likely to be the best way to encourage CIs to focus their research activity in areas of greatest need.

scholarly journals Cross-sectional analysis of UK research studies in 2015: results from a scoping project with the UK Health Research Authority

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022340 ◽  
Author(s):  
Tim Clark ◽  
Richard H Wicentowski ◽  
Matthew R Sydes
Keyword(s):  
Health Research ◽  
Clinical Studies ◽  
Public Involvement ◽  
Secondary Outcome ◽  
Ethical Review ◽  
Free Text ◽  
Research Activities ◽  
The Uk ◽  
The Impact ◽  
Research Studies

ObjectivesTo determine whether data on research studies held by the UK Health Research Authority (HRA) could be summarised automatically with minimal manual intervention. There are numerous initiatives to reduce research waste by improving the design, conduct, analysis and reporting of clinical studies. However, quantitative data on the characteristics of clinical studies and the impact of the various initiatives are limited.DesignFeasibility study, using 1 year of data.SettingWe worked with the HRA on a pilot study using research applications submitted for UK-wide ethical review. We extracted into a single dataset, information held in anonymised XML files by the Integrated Research Application System (IRAS) and the HRA Assessment Review Portal (HARP). Research applications from 2014 to 2016 were provided. We used standard text extraction methods to assess information held in free-text fields. We use simple, descriptive methods to summarise the research activities that we extracted.ParticipantsNot applicable—records-based studyInterventionsNot applicable.Primary and secondary outcome measuresFeasibility of extraction and processing.ResultsWe successfully imported 1775 non-duplicate research applications from the XML files into a single database. Of these, 963 were randomised controlled trials and 812 were other studies. Most studies received a favourable opinion. There was limited patient and public involvement in the studies. Most, but not all, studies were planned for publication of results. Novel study designs (eg, adaptive and Bayesian designs) were infrequently reported.ConclusionsWe have demonstrated that the data submitted from IRAS to the HRA and its HARP system are accessible and can be queried for information. We strongly encourage the development of fully resourced collaborative projects to further this work. This would aid understanding of how study characteristics change over time and across therapeutic areas, as well as the progress of initiatives to improve the quality and relevance of research studies.

scholarly journals Reviewing progress in public involvement in NIHR research: developing and implementing a new vision for the future

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e017124 ◽  
Author(s):  
Sophie Staniszewska ◽  
Simon Denegri ◽  
Rachel Matthews ◽  
Virginia Minogue
Keyword(s):  
Health Research ◽  
Online Survey ◽  
Public Involvement ◽  
Evidence Base ◽  
Advisory Panel ◽  
Barriers And Enablers ◽  
Expert Advisory ◽  
The Future ◽  
New Vision ◽  
The Uk

ObjectivesTo review the progress of public involvement (PPI) in NIHR (National Institute for Health Research) research, identify barriers and enablers, reflect on the influence of PPI on the wider health research system in the UK and internationally and develop a vision for public involvement in research for 2025. The developing evidence base, growing institutional commitment and public involvement activity highlight its growth as a significant international social movement.DesignThe ‘Breaking Boundaries Review’ was commissioned by the Department of Health. An expert advisory panel was convened. Data sources included: an online survey, international evidence sessions, workshop events, open submission of documents and supporting materials and existing systematic reviews. Thematic analysis identified key themes. NVivo was used for data management. The themes informed the report’s vision, mission and recommendations, published as ‘Going the Extra Mile—Improving the health and the wealth of the nation through public involvement in research’. The Review is now being implemented across the NIHR.ResultsThis paper reports the Review findings, the first of its type internationally. A range of barriers and enablers to progress were identified, including attitudes, resources, infrastructure, training and support and leadership. The importance of evidence to underpin practice and continuous improvement emerged. Co-production was identified as a concept central to strengthening public involvement in the future. The Vision and Mission are supported by four suggested measures of success, reach, refinement, relevance and relationships.ConclusionsThe NIHR is the first funder of its size and importance globally to review its approach to public involvement. While significant progress has been made, there is a need to consolidate progress and accelerate the spread of effective practice, drawing on evidence. The outcomes of the Review are being implemented across the NIHR. The findings and recommendations have transferability for other organisations, countries and individuals.

scholarly journals Reflective insights from developing a palliative care children and young people’s advisory group

2021 ◽  
pp. 026921632097603
Author(s):  
Anna Roach ◽  
Debbie Braybrook ◽  
Steve Marshall
Keyword(s):  
Palliative Care ◽  
Young People ◽  
Health Research ◽  
School Health ◽  
Public Involvement ◽  
After School ◽  
Advisory Group ◽  
Research Projects ◽  
Children And Young People ◽  
Care Research

Background: The importance of actively involving patient and public members throughout the different stages of palliative care and health research projects is widely acknowledged, however patient and public involvement work rarely considers insight from children and young people. Although this is becoming increasingly recognised in other areas of research, there is currently no structured guidance on how to best involve children and young people in palliative care research. Aim: To plan and deliver a Young People’s Advisory Group in palliative care and health research at a secondary school. Findings: Attending an after-school ‘Health and Social Research Methods Club’ for 11 weeks benefitted children and researchers. Children were taught about data collection methods, data analysis and ethics in health research and used these skills to provide valuable feedback which has been implemented in current palliative care research projects. Children took part in considered discussions around palliative care topics and enjoyed attending the group. Conclusion: This project has equipped researchers with skills and provided a structured template for future Young People’s Advisory Groups, ensuring the unique voices of children and young people are considered and valued in future palliative care research.

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