Patient and public involvement: Why patients are important not only as participants but as partners in developing research.

Posted on Apr 29, 2017 by Kelly Gleason in Research

It can feel overwhelming when you first invite patient representatives to help you with your research. Here are a few questions and ideas to help you get started…

Firstly, patients can help in clarifying the research question. Do patient perceive this as a problem? Do they see it as a problem worth investigating? Is the research question and purpose of the research clear and is it comprehensive or do patients have some ideas of what else could be added to the investigation?

Is the lay summary clear or are you having to look up words to understand terminology and procedures?

Looking at the study design and treatment schedule, are participant responsibilities clear? Are all visits, procedures and tests required over and above standard treatment clear to potential participants?

Do they think the ‘ask’ is reasonable for someone with this diagnosis? Do they agree with the inclusion and exclusion criteria? Are researchers asking for too much of participants, would taking part feel like a burden to patients (i.e. too much blood taken, too many procedures, too many visits)? Do you think patients would be happy to participate if invited or discouraged because of any specific aspect of the study design or treatment plan/schedule?

Could anything be done differently to make the study more acceptable to patients? Are there aspects of the study that require further explanations as to their importance if they will be a painful or uncomfortable part of the study i.e. arterial bloods, biopsies, long periods of time in a scanner etc). More diversity in the patient group, the richer your feedback.

Are side effects of the study drug clear? Are patients offered long term use of the study drug when the trial is over? Should they be offered this if the drug is effective?

Should participants be offered financial compensation for travel, meals, time given to the study? Would this incentivise participation in an appropriate way?

How should results of the study be disseminated to patients and the public?

Are patients included as part of a study management committee throughout the duration of the trial?

Has PPI been budgeted for?

Can PPI advise on recruitment strategies locally to support potential participants learning about the study and being offered the opportunity to take part?

Once funding has been granted for the project, patients can support by revising the Patient Information Sheet and Consent Form, making sure it is comprehensive and understandable to potential participants.

PPI can also ensure the Lay Summary for the Ethics Application is clear and easily understood.

Continued PPI in the study management committee can support problem solving as problems arise during planning and management of the trial. This could be in identifying potential participants, establishing successful recruitment strategies, reviewing amendments and commenting on best ways to disseminate update reports and final outcome findings to participants and the public.

Where strong relationships have been established with patients invested in a specific disease area, patients have been named as co-applicants of studies. This can be a very rewarding experience for both researchers and patient representatives. This interdependent relationship demonstrates a strong commitment to research.

You do not have to start our own group to benefit from patient involvement in your research, there are many, many groups out there that you can tap into or you can invite one or two patients with whom you have an established relationship to support you on one or two studies as a start. INVOLVE offers guidance on best practice when involving patients in research.

Today, you almost cannot be funded for a research project without demonstrating your PPI in a project. This shift in infrastructure is helping us put patients’ voices where they should be, at the heart of the research process. From research idea to dissemination of results, patients are why we do what we do, they should have a say at every stage. Why would even consider doing it any other way?