Patient and Caregiver Considerations in Eczema Clinical Trial Participation

When making decisions regarding eczema clinical trial participation (CTP), caregivers and adults with eczema gave similar ratings of importance to factors they considered when choosing whether to participate in trials, according to recent findings. However, caregivers were more likely than adult patients with eczema to take into greater consideration factors that may affect their child’s eczema or well-being.

“This study suggests the factors eczema patients and caregivers consider most and least important when considering CTP are largely the same,” the study authors wrote. “Caregivers, however, are more likely to attribute higher importance to factors that may affect the well-being of their child, such as the impact on overall health, possibility of a washout period, or the option to have a rescue therapy.”

The results of this survey-based, statistical analysis study were published in Contemporary Clinical Trials Communications.

The study was conducted using a 46-question online survey administered from May 1, 2020, to June 6, 2020, to individuals 18 years or older with eczema and adult caregivers of patients with pediatric eczema. Data collected from the survey included demographics, understanding and experience with clinical trials, and the factors that had been considered in the past in CTP decision-making.

Patients and caregivers included in the study had either considered CTP in the past but had not attempted it, attempted CTP but did not participate, or had participated in 1 or more trials. Participants were asked to rank the level of importance of factors that were considered regarding CTP from the following options: not important at all, of little importance, of medium importance, and of high importance.

A total of 1016 respondents participated in the survey, but 412 were excluded because they did not provide fully completed surveys.

Of the total 31 factors that were surveyed, patients (n = 470) and caregivers (n = 134) appeared to differ in their perceived importance of 11 factors.

The factors that were more likely to be rated important by caregivers were:

• The route of therapy (P = .030)
• Side effects (P = .014)
• Washout period (P = .028)
• Receiving a placebo (P = .027)
• Rescue therapy option (P = .033)
• Access to test drug after trial (P = .027)
• Sticking with the clinical trial regimen (P = .025)
• Fit with work/school (P = .005)
• Impact on overall health (P = .008)
• Satisfaction with current treatments (P = .033)

On the other hand, altruism was the only factor rated higher in importance by adult patients than caregivers (P = .027).

Additionally, caregivers of children aged 6 to 11 years were more likely than caregivers of children aged 12 to 17 years to report being the primary and only decider in whether their child participated in clinical trials and that their child was not included in any of the decision-making.

While more than half of caregivers reported they and their child need to agree on the decision to participant in clinical trials, 35% reported that they were the ultimate deciders.

The researchers of this study acknowledge some limitations, such as using a small selection size of patients, and the possibility of bias in the respondent’s survey answers.

Despite these limitations, the researchers believe this study adds insight into the factors that are important to patients and caregivers when considering eczema CTP and suggests the need for better communication and awareness about CTP among families who are considering these trials.

“These findings suggest the need for researchers to improve the quality and type of information they share to patients and caregivers about CTP, especially in regard to the risk: benefit relationship,” the researchers concluded. “Clinical trial information that is patient-centered has the opportunity to increase the understanding of patients and caregivers about CTs, allowing space for improved shared decision making within families prior to CT recruitment.”

Reference

Johnson JK, Loiselle A, Thibau IJ, Smith Begolka W. Factors related to eczema clinical trial participation among adult patients and caregivers. Contemp Clin Trials Commun. 2023;33:101138. doi:10.1016/j.conctc.2023.101138