@article{nokey,

title = {The READI European project: Enhancing inclusivity in  clinical research},

url = {https://onlinelibrary.wiley.com/doi/10.1111/eci.70146},

doi = {10.1111/eci.70146 },

year  = {2025},

date = {2025-10-28},

urldate = {2025-10-28},

journal = {European Journal of Clinical Investigation},

volume = {56},

note = {Source: It is produced within the READI project consortium.},

keywords = {Clinical Development / Trials, Inclusion and Representativeness in Clinical Research},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Lessons learnt from developing an ethnically diverse patient and public involvement group for breast cancer research},

url = {https://bmjopen.bmj.com/content/15/3/e091888},

doi = {10.1136/bmjopen-2024-091888},

year  = {2025},

date = {2025-03-03},

urldate = {2025-03-03},

journal = {BMJ Open},

volume = {15},

abstract = {Objective: There is evidence that those who typically contribute to patient and public involvement (PPI) activities do not reflect the diversity of the population, and individuals from underserved groups are less likely to participate in healthcare research. For some researchers, understanding how to embed diversity into their PPI work can be confusing and challenging. The aim of this communication article is to reflect on our experiences and share the lessons learnt from developing an ethnically diverse PPI group to co-deliver breast cancer research.



Key points: Researchers must be realistic about timelines at both the grant application stage and during the research project, as finding contributors for inclusive and diverse PPI work takes time. Researchers will benefit from utilisation of existing expertise and resources within existing PPI teams at research institutions. It is vitally important to be clear about what researchers need in terms of contributors and what the PPI activities will be at different stages of the research project.



Conclusions: Conducting effective, diverse and meaningful PPI is a research skill that needs to be learnt and practised just like any other. Well-developed inclusive PPI has significant benefits for both researchers and the public.},

note = {Source: BMJ Open},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = { World Cafés as a participatory  approach to understanding research agendas  in primary care with underserved communities:  reflections, challenges and lessons learned},

url = {https://doi.org/10.1186/s40900-023-00509-3},

doi = {10.1186/s40900-023-00509-3},

year  = {2024},

date = {2024-07-02},

urldate = {2024-07-02},

journal = {Research Involvement and Engagement},

volume = {10},

note = {Source: BioMed Central, Springer Nature},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {A toolkit for capturing a representative and equitable sample in health research},

url = {https://www.nature.com/articles/s41591-023-02665-1},

doi = {10.1038/s41591-023-02665-1},

year  = {2023},

date = {2023-12-08},

urldate = {2023-12-08},

journal = {Nature Medicine},

volume = {29},

issue = {12},

pages = {3259–3267},

note = {Source: Springer Nature},

keywords = {Clinical Development / Trials, Inclusion and Representativeness in Clinical Research},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Checklist to assess Trustworthiness  in RAndomised Controlled Trials (TRACT  checklist): concept proposal and pilot},

url = {https://link.springer.com/article/10.1186/s41073-023-00130-8},

doi = {10.1186/s41073-023-00130-8},

year  = {2023},

date = {2023-06-20},

urldate = {2023-06-20},

journal = {Research Integrity and Peer Review},

volume = {8},

abstract = {Objectives 

To propose a checklist that can be used to assess trustworthiness of randomized controlled trials (RCTs).



Design 

A screening tool was developed using the four-stage approach proposed by Moher et al. This included defining the scope, reviewing the evidence base, suggesting a list of items from piloting, and holding a consensus meeting. The initial checklist was set-up by a core group who had been involved in the assessment of problematic RCTs for several years. We piloted this in a consensus panel of several stakeholders, including health professionals, reviewers, journal editors, policymakers, researchers, and evidence-synthesis specialists. Each member was asked to score three articles with the checklist and the results were then discussed in consensus meetings.



Outcome 

The Trustworthiness in RAndomised Clinical Trials (TRACT) checklist includes 19 items organised into seven domains that are applicable to every RCT: 1) Governance, 2) Author Group, 3) Plausibility of Intervention Usage, 4) Timeframe, 5) Drop-out Rates, 6) Baseline Characteristics, and 7) Outcomes. Each item can be answered as either no concerns, some concerns/no information, or major concerns. If a study is assessed and found to have a majority of items rated at a major concern level, then editors, reviewers or evidence synthesizers should consider a more thorough investigation, including assessment of original individual participant data.



Conclusions 

The TRACT checklist is the first checklist developed specifically to detect trustworthiness issues in RCTs. It might help editors, publishers and researchers to screen for such issues in submitted or published RCTs in a transparent and replicable manner.},

note = {Source: Published in BioMed Central (BMC), Springer Nature},

keywords = {Clinical Development / Trials, Inclusion and Representativeness in Clinical Research},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era},

url = {https://link.springer.com/article/10.1186/s40900-021-00250-9},

doi = {10.1186/s40900-021-00250-9},

year  = {2021},

date = {2021-03-08},

urldate = {2021-03-08},

journal = {Research Involvement and Engagement},

volume = {7},

abstract = {Background:



Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial.



Methods:



RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference.



Results:



Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice.



Conclusions:



PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.},

note = {Source: BioMed Central, Springer Nature},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Broadening diversity through creative involvement to identify research priorities},

url = {https://link.springer.com/article/10.1186/s40900-020-00244-z},

doi = {10.1186/s40900-020-00244-z},

year  = {2021},

date = {2021-01-06},

urldate = {2021-01-06},

journal = {Research Involvement and Engagement},

volume = {7},

abstract = {Background: Patient and public involvement (PPI) can help with steering and shaping research prioritisation and execution. However, some groups of people may not be encouraged to take part and their voices may be seldom listened to in the production of research. This is important to consider because they may have poorer healthcare experiences. We tried using art as a vehicle for including individuals not necessarily invited to be part of research priority setting.



Methods: We contacted existing groups and organisations to reach people not routinely supported to be part of PPI. We targeted individuals: a) with dementia, b) with a mental and physical health condition, c) of South Asian heritage. We ran a workshop with each group at which individuals shared their experiences of healthcare. A young amateur artist also attended, who produced a piece of artwork afterwards that reflected the research priorities raised. We held a Twitter chat to discuss these pieces of art and the processes involved in their generation.



Results: From each workshop, we produced a list of research priorities. These included: a) improving coordination of care for people with dementia, b) information needs and anxiety/guilt around accessing care for people with physical and mental health conditions, c) supporting discussion of women’s health issues in South Asian communities. These priorities were reflected in three pieces of art, which can be viewed online. Feedback from those at workshops suggested that the artwork helped them to feel that their voice had been heard and triggered their interest in how research is developed. Those involved in the Twitter chat commented that art was one means through which researchers could connect with a range of groups in a PPI context when preparing and producing a study.



Conclusions: We found the medium of art to be an effective way of including a range of people in research prioritisation setting. This approach could be useful for future PPI, building on what we have learnt from the project described in this paper.},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}