It ought to accomplish what is stipulated on the receptacle – why plain English matters

The ISRCTN registry has included plain English summaries in their study records since 2011 and currently contains over 4600 of them. But just how important are they and what can be done to ensure that they really are written in plain English?

A plain English summary aims to describe research to a non-specialist audience. This is commonly intended to make the research accessible to members of the public, but is also valuable for health professionals who are not specialized in that specific field of research.

Researchers are increasingly expected to provide plain English summaries of their research, often at several stages. A good quality plain English summary helps reviewers and panel members better understand the research proposal; funders to understand and publicize the research that they fund; and non-expert readers to understand the study. This has led to the UK National Institute for Health Research (NIHR) making the inclusion of plain English summaries a requirement when applying for NIHR funding. They are also useful as part of the process by which potential participants may decide to join a clinical trial – as the accessible language helps to explain exactly what taking part would mean for them.

The UK Clinical Trials Gateway (UKCTG) was set up to provide patients and the public with information about clinical trials in the UK,  pulling in information from three different sources: the ISRCTN registry, Clinicaltrials.gov and the NHS Central Portfolio Management System (CPMS). Of these, only the ISRCTN registry asks trialists to provide a structured plain English summary, which is then reviewed by a team of Database Editors, who help make the summary as accessible as possible. This information is then displayed in the summary section of the UKCTG study record. As Clinicaltrials.gov records do not provide a plain English summary, the UKCTG uses the information from their “Brief Summary” section instead.

What makes a good plain English summary?

We put this question to two people; Sophie Petit-Zeman, Director of Patient Involvement from the NIHR Oxford Biomedical Research Centre and Sarah Kimber, a patient information manager from Cancer Research UK.

Despite their different backgrounds, their views of what a good plain English summary should look like were very much in line with those set out by the NIHR Involve Advisory Group.

Sarah goes on to say that the key features of a plain English summary are “ensuring the information is accessible- [which means] use of plain English, not using jargon or medical terms, and –  where these are used – give a full explanation, keeping in mind literacy levels and use of formatting to help comprehension.”

The key features of a plain English summary are “ensuring the information is accessible- [which means] use of plain English, not using jargon or medical terms, and –  where these are used – give a full explanation, keeping in mind literacy levels and use of formatting to help comprehension.”


Sarah Kimber, Patient Information Manager, Cancer Research UK

She also emphasized the importance of making sure that plain English summaries “cover what people need to know if they would want to take part in a trial. […] provide an overview of what the trial is about and why it is being done, [including] entry criteria, details of how the trial will work, impact in terms of hospital visits/time spent related to the trial (including follow up and side effects of treatment/intervention).”

Is there any evidence for their impact?

One of the most common arguments for the inclusion of plain English summaries is that they are useful for people who are looking to take part in a study. However, is there actually any evidence that this is the case? When asked her opinion on this subject, Sarah Kimber commented that:

“We hope that by having plain English summaries available people can more easily find a trial that is suitable for them or their friend or relative. We assume this helps with people’s involvement in research but I don’t have any evidence to back this.”

Sophie Petit-Zeman goes one step further, stating that:

“We all say we need to ensure trials have good lay summaries […] but do we actually know how often people see information about trials on the registries or on UKCTG and then ask their doctors for more information? If very few currently come via this route it may be because the lay summaries are bad, and making them better may increase recruitment.”

One way Sophie proposes this could be improved is by involving members of the public in writing them. This concept, known as patient and public involvement (PPI), is considered an important part of developing both health services and clinical research. Indeed, the NIHR Oxford Biomedical Research Centre recommends that there should PPI in the writing of all plain English summaries for study records and provides a service, whereby a PPI working group works with researchers to help create them.

The BioMed Central journal Research Involvement and Engagement recently published an article in which a researcher recounted a time when he was not able to recruit a single participant to one of the three arms of a study due, in part at least, to the burden of study visits in addition to their regular hospital visits. The researcher concedes that “PPI groups are better placed to decide whether what is being asked of them in research participation is reasonable and worthwhile”.

Although there is not a lot of quantitative evidence as yet, a number of studies have shown that PPI is of benefit to clinical trials, particularly if implemented early in the process and if the chief investigators had clear plans for PPI. These benefits include, for example, helping to improve the design of clinical trials and increasing participant recruitment.

What do people think of ISRCTNs plain English summaries?

Recognizing the importance of PPI, the ISRCTN registry recently conducted a survey, contacting patient reviewers for the Research Involvement and Engagement journal, asking them to comment on the quality of our plain English summaries.

In general, the feedback was positive.

One reviewer commented on a study looking at whether recovery and survival rates of injured civilians in a warzone depended on what transport was used to take them to hospital, noting that the plain English summary was “easy to read and follow” and that it was written “just as ordinary people would talk to one another, without all of the technical jargon”.

Another reviewer said that she liked the “clear, concise explanations given for medical terms and procedures” of a summary explaining a cancer study but there was one term (open distal pancreatectomy) that was not explained. They also pointed out that any potential risks and benefits of participating should be added.

A poorly written plain English summary would make potential participants feel less confident about the competence of the researchers


Reviewer comments

A reviewer of this study suggested that, although the plain English summary was easy for them to understand, improvements could be made via “clarity in all descriptions, even if that entails a very brief description of a complex term. It’s important that for those with zero experience of the issue in hand, everything can be understood. Involving patients AND members of the public (with no experience of condition area) in this process is helpful”.

Not all the reviewers were positive, however. We did receive one scathing review of a plain English summary stating it contained words that assumed existing knowledge (for example “observational study”) and medical jargon. Another reviewer mentioned that the plain English summary for one study introduced “some unexplained equipment and mention of bruise after a blood test came as a shock as the test was not mentioned earlier”.

Interestingly, when asked whether they thought that the quality of a plain English summary would influence their decision to take part in a study, several reviewers made the point that a poorly written plain English summary would make them feel less confident about how competent the researchers were and less likely to trust them enough to want to take part in their study.

We can always do better

The ISRCTN registry currently contains over 4600 plain English summaries, with the number growing daily. Our guidelines are constantly evolving and we have carefully considered the feedback that we received from our survey, to ensure that the health condition being studied and the problem or question being addressed is clearly explained, confirming that all tests that a participant has to undergo are listed and that every effort is made to avoid using jargon or complex terms (or explaining them afterwards).

The message from this is clear: The best way to improve a plain English summary is to employ the help of the people who are going to make use of them. ISRCTN will continue to ask lay reviewers for their feedback, possibly eventually asking them to contribute directly to their construction, to make our plain English summaries accessible to more people than ever before.

 

 

 

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