Clinical Trial Results Summary for Laypersons: A User Testing Study

Raynor, David K.; Myers, Laurie; Blackwell, K; Kress, B; Dubost, A; Joos, Angelika

doi:10.1177/2168479017753129

Cited by 11 publications

(18 citation statements)

References 9 publications

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“…An EU Clinical Trials regulation introduced in 2014 and set to be fully implemented in 2021 mandates publication of a lay summary within a year of the end of a trial [54]. As with the role of patients, carers and the public in supporting development of accessible and comprehensible trial literature, involving these groups in the development of lay summaries has been successfully used to enhance their value to the intended audience [55]. This will enable better-quality summaries to be produced which not only fulfill regulatory obligations but also provide useful information to patients.…”

Section: Disseminating Research Results To Patientsmentioning

confidence: 99%

Patient Engagement in Cancer Research from the Patient’s Perspective

Spears

2021

Future Oncol.

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Patient engagement in cancer research involves the inclusion of patient voices into research to ensure knowledge generated will improve the lives of all cancer patients. Patients involved in research have an interest in science, an experience with cancer and want to work directly with researchers to ensure patient concerns are heard. There are many opportunities for patient engagement in laboratory and clinical research, throughout the lifecycle of the project from conception to completion. Researchers and patient advocates can take practical steps to ensure their engagement is effective and meaningful. Adding the patient voice in research honors those who have died, so future cancer patients have access to new therapies to live longer and better lives.

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Section: Disseminating Research Results To Patientsmentioning

confidence: 99%

Patient Engagement in Cancer Research from the Patient’s Perspective

Spears

2021

Future Oncol.

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“…For instance, if the entire clinical trial process has been simplified in the way they are conducted, it provides a common man with an idea of knowing the most recent innovations, besides letting them understand scientific literature in their perspectives. It could also be a means of motivation for patients to participate in clinical trials and take advantage of the newer therapies before it can be made available to a wider public 2 . Thus, it is always important for researchers to keep in mind that any scholarly work aims to make it available to, and understandable by the general public and the scientific community.…”

Section: Pls Facilitates Knowledge Translation (Kt)mentioning

confidence: 99%

Plain‐language summaries: An essential component to promote knowledge translation

Gudi

Tiwari

Panjwani³

2021

Int J Clinical Practice

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In this era of evidence‐based practice, scholarly work such as peer‐reviewed scientific publications plays a vital role in policy and decision‐making at an individual, organisation and country‐level. Alongside being considered an essential means of communicating scholarly work, scientific publications also investigate the specific domains that lack well‐established literature and thereby inform scientists and researchers to thrive for the betterment of the publics' well‐being. Thus, the main purpose of articulating the scientific, scholarly work should be to make it understandable and accessible to everyone, including the lay audience. However, oftentimes, researchers overlook the lay summaries while publishing the research findings.

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“…The EU CTR guidance advises reader testing when feasible [4]. Additionally, a recent study by Raynor et al demonstrated that user testing can be used to improve the readability and acceptability of lay summaries to the non-medical public [13].…”

Section: What To Consider When Creating a Lay Summarymentioning

confidence: 99%

Lay Summaries of Clinical Study Results: An Overview

Barnes¹,

Patrick²

2019

Pharm Med

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The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a complement to other forms of clinical study disclosure such as registry postings and scientific publications, lay summaries may aid in the transparency of a sponsor's clinical study results, thereby promoting trust, partnership, and patient engagement throughout the clinical study process. The data transparency field is changing rapidly; therefore, data owners should strive to stay abreast of the changes and deliver meaningful tools to their study participants and the public. Points to consider when developing lay summaries of clinical study results include regulatory drivers, the target audience, communication of complex data in a lay manner, and efficient processes for the development of lay summaries within one's company. Plain Language SummaryThere is a rule in Europe that clinical studies (experiments in humans) must have a summary written in plain language. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. People who participate in clinical studies, and others, may want to know information about clinical study results. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Lay summary writers must think about how they can help readers understand the information. It is hard to describe the results of clinical studies in a way that everyone can understand. This article gives some ideas to think about when writing lay summaries. * Amber Barnes amber.barnes@ucb.com 1 UCB Bioscience, RTP, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA Key PointsLay summaries of clinical study results are a complement to other forms of clinical study disclosure that aid in the understanding of complex clinical study results.The initial requirement for lay summaries began as a result of the EU Clinical Trial Regulation; however, evolving regulations and policies around the globe are shaping the future of clinical study disclosure.Ensuring patient value should be of paramount importance when developing lay summaries.

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Clinical Trial Results Summary for Laypersons: A User Testing Study

Abstract: Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

Cited by 11 publications

References 9 publications

Patient Engagement in Cancer Research from the Patient’s Perspective

Patient Engagement in Cancer Research from the Patient’s Perspective

Plain‐language summaries: An essential component to promote knowledge translation

Lay Summaries of Clinical Study Results: An Overview

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