METHODICAL Study
Research priorities for

Patient and Public Involvement (PPI) in Clinical Trials

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The history of the METHODICAL project

  • The start of METHODICAL

    2015

    The start of METHODICAL

    The METHODICAL project was funded by the MRC Hub for Trials Methodology Research Network in 2015 to understand priorities of key stakeholders involved in patient and public involvement in clinical trials. The aims was to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid research waste

  • Online Delphi Survey

    November 2015-March 2016

    Online Delphi Survey

    An online survey (Delphi) was undertaken with over 200 people taking part. Participants from all aspects of PPI in clinical research (PPI representatives, Lay reviewers, Chief investigators and trial managers, PPI coordinators, non-lay reviewers, PPI advisors and PPI researchers) shared their opinions of what research is important.

  • Consensus Meeting

    March 2016

    Consensus Meeting

    A random selection of survey participants were invited to a face to face meeting with study team members to discuss the results of the online survey and to take a final vote on which research is important.

  • Research Priorities Identified

    March 2016

    Research Priorities Identified

    Research topics were ranked according to the scores during the anonymous vote within the consensus meeting. Topics which achieved over 70% of scores 7-9 were found to be of critical importance.

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    Ongoing

    Working groups

    Our aim is to establish working groups for the research topics identified as critical. For more information and details of how to get involved see Working groups

Results of the METHODICAL study

We had a good response to the online survey. Of the 237 people who started the survey, 219 (92%) completed the first round. 36 topics were discussed in round one and 81 topics were suggested for round two. After reviewing the suggested topics, the study team felt that over half of these were covered by the existing topics. The remaining suggestions were used to create 6 new topics which were added to the second round. 187 of 219 (85%) completed the second part of the survey.

An equal mix of lay and non-lay participants were invited a face to face consensus meeting to discuss the 42 research topics used in the survey. 25 people attended (52% non-lay and 48% lay). During the discussion it was decided that two topics should not be included as they were too broad or overlapped with other topics. Following an anonymous vote, 16 of the 40 topics were found to be of critical importance to addressing uncertainties in PPI in clinical trials.

The full results of the METHODICAL study can be seen in Health Expectations Journal using the link below. Alternatively please read our plain English summary of the study and our results.

Working groups

Working groups

Following on from the METHODICAL project we would like to help start working groups for each of the topics identified as critically important research at the consensus meeting. The aim is to help coordinate collaborative working and help reduce research waste. Here is some more information about the working groups:

Purpose: The purpose of the groups are to provide an opportunity for people interested in the topic to work together to develop research grant proposals. These groups will be independent of the METHODICAL study, although some of the study team members may wish to become members of a group. We have begun identifying people who are interested in each group in order to organise an initial teleconference call. After this we will then pass over the running of the working groups to the ‘PPI community’.

Funding/ Expenses: Please note there is no funding for these groups and we cannot cover expenses or fees for involvement.

How to get involved: All the critical research topics are listed in the table below. If you would like to know more about a particular working group please use the contact details on the right handside of the table to contact the coordinator directly. Further details about each topic can be found in the list of results



Ranking Topic Contact
1 Developing strong and productive working relationships between researchers and PPI contributors Kerry Woolfall (woolfall@liverpool.ac.uk)
1 PPI practices in selecting trial outcomes of importance to patients Heather Bagley (Heather.Bagley@liverpool.ac.uk)
1 A systematic review of PPI activity in improving the accessibility and usefulness of trial leaflets and information sheets for clinical trial participants Jim Elliot/ Adwoa Parker (adwoa.parker@york.ac.uk)
4 Adapting PPI to the particular needs of individual clinical trials Beth Deja (bdeja1@liverpool.ac.uk)
4 The resources needed for PPI activity including time and money To be confirmed (Use the contact details on the website)
4 PPI practices to address the challenges of recruiting and retaining participants (e.g. patients) in clinical trials Joanna Crocker (joanna.crocker@phc.ox.ac.uk)
7 PPI practices in selecting how to measure trial outcomes To be confirmed (Use the contact details on the website)
8 How is PPI involved in the dissemination of results and assessment of effectiveness? Katie Gillies (k.gillies@abdn.ac.uk)
9 How do PPI contributors achieve and maintain an authentic patient perspective? Delia Muir (D.P.Muir@leeds.ac.uk)
10
AND
16
Effectiveness of different methods to capture wider patient or public perspectives on clinical trial designs e.g. surveys, social media
AND
Assessment of different methods (e.g. social media, incentives) to increase the diversity of PPI contributors (age, ethnicity, socioeconomic status, disability)
Kerry Woolfall (woolfall@liverpool.ac.uk)
10 What is the impact of PPI activity on the experience of patients who participate in a clinical trial? Claire Planner (Claire.Planner@manchester.ac.uk)
12 Developing critical appraisal guidelines for funding boards to assess PPI activity within funding application forms Beth Deja (bdeja1@liverpool.ac.uk)
13 Exploring the role of PPI in the early stages of testing of new treatments (e.g. Phase 1 and Phase 2 trials) To be confirmed (Use the contact details on the website)
14 Reviewing PPI and the involvement of patients in setting research priorities for different health conditions. To be confirmed (Use the contact details on the website)
15 Core outcomes for assessing PPI impact To be confirmed (Use the contact details on the website)

The METHODICAL Team

The METHODICAL study was organised by Dr Kerry Woolfall and overseen by a study team of researchers and PPI coordinators from across the UK. Three PPI partners were selected at the outset to join the study team. They have been involved and in all aspects of the study, including generation of topics, review of new topics, interpretation and delivery of the results.

Kerry Woolfall

Chief Investigator

Anna Kearney

Research Associate

Members of the METHODICAL oversight team: Paula Williamson, Bridget Young, Heather Bagley, Carrol Gamble, Simon Denegri, Delia Muir, Natalie Simon, Stephen Thomas, Jim Elliot, Helen Bulbeck, Joanna Crocker, Claire Planner, Claire Vale, Mike Clarke, Tim Sprosen

Contact Us

For more information about the study or to join a working group, please contact Kerry Woolfall (woolfall@liverpool.ac.uk)