Research Design Service: East Midlands

Latest News

New guidance on end of life care in frailty

  Created on Thursday, 17 Sep 2020. Posted in End of life care

The aim of this guidance is to support clinicians and others in considering the needs of and providing high quality care for frail older people as they move towards the end of their lives. It aims to prompt and support timely discussions about preferences for care, ideally at a time which facilitates the input of the older person themselves.

If you are researching in the area of end of life care this is a valuable guide to the issues around endo of life care and current best practice.

Introduction to social care research

  Created on Thursday, 17 Sep 2020. Posted in Social Care

Great introduction to social care research by Martin Knapp from the NIHR School for Social Care Research (SSCR). For more information about the SSCR take a look that their website and join the weekly Tuesday lunchtime webinars.


Process evaluation – HTA tips from the funding committees

  Created on Thursday, 13 Aug 2020. Posted in Funding

Make sure the case of need and cost is described clearly, and the process evaluation activities are well integrated into the main study and not confused with other qualitative or recruitment optimisation activities

  • Needs to be well justified – usually process evaluation is seen in complex interventions to help explain why a treatment works or doesn’t work, for whom and in what context. But it’s not required unless it is justified which maybe more the case for new interventions or new care pathways
  • Take care how you describe it – too much detail will suggest that you are preparing for failure
  • Needs to be clearly differentiated from other qualitative elements of the study
  • Needs to be fit for purpose – you need to justify complexity and cost (remember HTA are aiming for rapid, simple and efficient trials)
  • Remember although implementation is normally considered within a process evaluation, planning and undertaking implementation work beyond the main trial findings is out of remit for HTA
  • Must be clearly integrated into the overall study – must clearly relate to key decisions and interpretation of the data

If the above criteria are met then take a look at the MRC guidance on how to design and conduct process evaluation 


Changes/updates to the SAF, with some specific changes relating to PPI

  Created on Tuesday, 30 Jun 2020. Posted in Public Involvement | Funding

Stage 1

  • Inclusion of public co-applicants, where appropriate, with a clear description of their role and the reasons why a public co-applicant is joining the team
  • PPI Lead - There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. This role should be an adequately costed and resourced research team member who is able to manage the PPI plans and related activities.
  • Justification of health/care need - Identify how will the public/patients see this as a need and as a potential improvement to their health and/or lives? 
  • Project Plan (Patient and Public Involvement):

o   show your plans for involving patients/service user, carers and the public at each appropriate stage of the research project lifecycle

o   outline how PPI has informed the development of the project so far, including how it has specifically shaped the research question and study design 

  • Dissemination plans: include details of how you will share with study participants the progress and findings of the study (PPI could inform this)

Stage 2

As stage 1, but also:

  • PPI Section:
  1. NEW PPI approach, management and support section to include:
  • why your approach to patient and public involvement is appropriate, including who will be involved and why
  • how you plan to manage and coordinate the patient and public involvement activities
  • how you will support and enable patients/service users, carers, the public and members of relevant communities to contribute to your research (e.g. access, payments, training).
  • outline plans for the capturing, evaluating and reporting the impact of patient and public involvement activities
  1. NEW Summary of PPI activities, including
  • a summary of the proposed PPI activities embedded throughout the research project lifecycle
  • clearly signpost to other sections of the Detailed Research Plan where the PPI is described further in relation to the relevant project stage
  • Costings - If voluntary, charity or community groups are supporting the research via activities such as facilitating contact with potential participants, hosting research activities or providing advice, an adequate budget must be included to compensate for their time and resources.


Recruiting participants for adult social care studies: challenges and mitigating strategies METHODS REVIEW

  Created on Monday, 22 Jun 2020. Posted in Guidance | Social Care

This Methods Review aimed to describe the challenges in recruiting organisations and individuals for adult social care research and identify possible strategies to address them.

One of the main barriers to recruitment was variation among provider organisations, so recruitment strategies needed to be adjusted for different organisations, many of which lacked capacity for research participation. The rapidly changing nature of adult social care organisation and delivery in England also means that recruitment strategies often need to be adapted while research is in progress. Building partnerships between researchers and providers and offering financial and other incentives were suggested as mitigating strategies. In recruiting individuals, a lack of understanding of research benefit and organisations’ gatekeeping arrangements were common difficulties. Interviewees suggested: raising public awareness of adult social care research; building relationships with user/carer groups; using a variety of recruitment strategies and offering a range of participation routes. Researchers and funding bodies should allow sufficient time and resources to recruit representative samples. Researchers should share recruitment knowledge.

Covid-19 rapid response research calls: views from public contributors

  Created on Wednesday, 10 Jun 2020. Posted in Public Involvement

  • Due to the short turnaround time of one year, the public will want to know what the impact of the study will be on people and communities - what difference will the research make to our lives?
  • Lab based studies particularly can benefit from developing a dissemination strategy. The public have a right to know about the impact the research makes and there is also interest for this to happen more meaningfully and at scale.
  • Research applicants don’t always demonstrate how they plan to engage and involve people and communities in their study even if they are already doing it - put it in the form.
  • Research applicants who have access to established PPIE groups and networks tend to have stronger PPI input in their application - if you don’t have existing groups to reach out to, you can access Covid research specific PPIE groups through the HRA UK Covid-19 PI in Research database
  • NIHR has an expectation that there is PPI in every research study, indeed it's listed in the guidance document for the call.
  • Applicants need to demonstrate more robustly how they plan to reach out to people and communities from diverse backgrounds particularly from BAME communities, recognizing that this is not a homogenous group.
  • Some of the applications are lab-based or involve animals, which is new to some reviewers. Appreciate that PPI is challenging in basic research,and tight timeframe doesn’t allow researchers to learn about PPI. Some of them seem to think that they don’t need to do PPIE. Every case they could have done PPIE had they had the time, resources, inclination.
  • Where an application is low in detail, it is usually low in plans for PPIE too.
  • This is a great opportunity to dissemination. Lab-based researchers who don’t build in PPI miss the point of what the general public is concerned about.
  • Reasonable amount of PPI at the beginning, since then reduction, not sure why this is happening but concerning. Seems to be happening everywhere - HRA, ethics committees are also seeing less PPI.
  • Some applicants use the science as an ‘excuse’ for not having PPI. Understand if it’s not possible in the science part but the overarching governance, consent over samples should not be missing.
  • Feeling in the PPI area that PPI is still an add-on; some researchers still think that when they need to be speedy, PPI can be dropped.
  • Disconnect between seeing patients as participants and thinking that is PPI.

Reimagining research - Wellcome report

  Created on Tuesday, 19 May 2020. Posted in Literature

Wellcome has published a report, What researchers think about the culture they work in. The results are based on a survey of more than 4,000 researchers in the UK and globally, and nearly 100 in-depth interviews.

Equality, diversity and inclusion in Patient and Public Involvement and Engagement

  Created on Tuesday, 12 May 2020. Posted in Public Involvement | EDI

As part of NIHR's commitment to actively and openly supporting and promoting equality, diversity, and inclusion (EDI) they've produced new Standard Application Form (SAF) guidance that includes improved requirements to will strengthen EDI and patient, public involvement and engagement (PPIE).

Core outcome set - response to COVID-19

  Created on Friday, 01 May 2020. Posted in Priorities | Methods

Many clinical trials and systematic reviews are already underway, or will begin shortly, to strengthen the evidence base for the COVID-19 response. Core outcome sets (COS), showing the outcomes that should be measured and reported in these studies, will ensure that this evidence base will contain, as a minimum, the key information needed by decision makers about the effects of interventions.

COMET core outcome sets for trials and systematic reviews

COVID-19 Research and Platform (Complex Innovative Design) Trials

  Created on Thursday, 30 Apr 2020. Posted in Methods

A Platform study allows for several experimental treatments to be studied simultaneously. In addition, new experimental treatments can be integrated into an existing study rather than setting up a new study. This allows for more efficient research

diagram of a platform study