Fear: a critical barrier to participation in healthcare research
The results of a global review of more than 400 studies suggest that fear over new medicines and unknown side effects, as well as increasing concerns over privacy and confidentially, may represent key barriers to individuals’ participation in healthcare research.
An estimated two-thirds of clinical trials – including those investigating novel therapeutics – fail to recruit their target numbers of trial participants in the UK. Now, a team of researchers from the University of York and Hull York Medical School (both UK) has conducted a global review of 429 unique primary studies and determined that fear of adverse treatment effects and concerns over privacy and confidentiality may be significant contributing factors underlying this recruitment failure.
Senior study author Peter Knapp (University of York and Hull York Medical School) explained: “Clinical trials are an essential part of developing new medicines and improving healthcare, but recruiting patients to take part is one of the biggest challenges researchers face.”
In this study, researchers reviewed 26 quantitative, qualitative or mixed methods systematic reviews, including a total of 429 unique primary studies, which explored psychosocial determinants of individuals’ willingness to participate in health research. Common determinants were categorized and mapped to strategies designed to increase trial participation, to determine the effectiveness of these and how targeted they are to individuals' worries.
Researchers identified a small number of recurring psychosocial determinants that increased individuals’ willingness to participate in trials, including perceived personal benefits from participating in the research, potential therapeutic benefit and access to novel treatments. These ‘facilitators’ were not contextually limited, by study or disease type for example.
By contrast, identified psychosocial ‘barriers’ to individuals’ willingness to participate in trials were more sensitive to research context and individuals’ circumstances; fear, related to being exposed to novel treatments with unknown or uncharacterized side effects, was a common, prominent barrier. Distrust in research was also identified as a common barrier, specifically amongst minority ethnic groups.
Further, when these facilitators and barriers were mapped to recruitment strategies, designed to encourage trial participation, researchers observed that a number of identified psychosocial determinants had no clear link to any evaluated recruitment intervention.
Knapp commented: “…we found quite a few gaps between the main reasons people gave for their reluctance to take part and the interventions currently in place in healthcare systems like the NHS to try to remove barriers to participation. There is a need for more research to identify effective recruitment strategies that draw on psychological theory and the facilitators and barriers identified in this overview.”
“Feelings of fearfulness are clearly a key issue and so it would make sense to look at interventions focused on directly addressing patient concerns,” Knapp concluded.
The study authors acknowledge that their mapping of determinants affecting health research participation to methods designed to increased clinical trial recruitment specifically may account for some of the observed poor overlap between participation barriers and interventions designed to combat these. However, the study authors argue that no interventions pertaining to general health research exist, so utilizing clinical trial recruitment strategies was the next best option.
Sheridan R, Martin-Kerry J, Hudson J, Parker A, Bower P, Knapp P. Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators. Trials. 21: 259 (2020); www.york.ac.uk/news-and-events/news/2020/research/people-fearful-taking-part-clinical-research/