Informing Subjects of Epidemiologic Study Results

Abstract

Objective. To assess the feasibility and process of providing feedback to parents regarding the results of epidemiologic research, in particular to look at the importance and clarity of the information provided, parental reactions to the results, and utilization of the data provided. Methodology. Parents who participated in an epidemiologic study of pediatric brain tumors (patient and control mothers) were sent a letter summarizing the results of the study and the Parent Study Results Survey to complete and return. The final sample used for analyses was 109 (patient) and 90 (control) mothers. Analyses were conducted to determine differences between patient and control mothers and differences among subsets defined by educational level and vital status of the patient. Results. Mothers rated the importance and clarity of the information very highly, although patient mothers were more likely than control mothers to want more information and a telephone contact. Patient and control mothers were similar in reported sadness, anxiety, and being overwhelmed, but patient mothers felt less satisfied and relieved. Patient mothers expressed feeling more guilt and anger than control mothers, although even the levels among the patient mothers were only moderate. Close to half of all mothers commented on the inconclusiveness of the study results. Nearly all mothers indicated they would suggest that other parents participate in epidemiologic research. Conclusions. It is valuable to many parents that they receive information about results of research in which they have participated. We found little evidence of strong negative effects to a detailed feedback letter. We recommend that evaluative data be used to guide the process of informing research participants about study results and that investigators consider making feedback letters a standard part of research protocols.

Developing lay summaries and thank you notes in paediatric pragmatic clinical trials

“…In one study, >50% of parents of paediatric participants in a rheumatologic clinical trial reported increased interest in participating in subsequent research after receiving the results of the current trial in which their child was participating 5 . In another study, mothers of children with and without cancer acknowledged interest in participating in subsequent epidemiologic research after the return of study results 6 . Study participants have also expressed interest in learning study results even when there is no immediate or future personal benefit 7 …”

“…Nevertheless, communication of aggregate results through lay summaries is likely a feasible and necessary endeavour for public health, for which investigators have evaluated the acceptability and impact 11–13 . Prior studies have focused on lay summary distribution in the setting of life‐threatening illness or chronic disease, where traditional, randomized trials evaluate the safety and efficacy of targeted therapeutics 5,6,11,14 . Little is known about the provision of lay summaries outside these specific patient populations and study designs.…”

“…5 In another study, mothers of children with and without cancer acknowledged interest in participating in subsequent epidemiologic research after the return of study results. 6 Study participants have also expressed interest in learning study results even when there is no immediate or future personal benefit. 7 According to the National Academy of Medicine (formerly The Institute of Medicine), return of results is a 'matter of public transparency and respect' for those who make scientific advances possible.…”

“… 5 In another study, mothers of children with and without cancer acknowledged interest in participating in subsequent epidemiologic research after the return of study results. 6 Study participants have also expressed interest in learning study results even when there is no immediate or future personal benefit. 7 …”

“… 11 , 12 , 13 Prior studies have focused on lay summary distribution in the setting of life‐threatening illness or chronic disease, where traditional, randomized trials evaluate the safety and efficacy of targeted therapeutics. 5 , 6 , 11 , 14 Little is known about the provision of lay summaries outside these specific patient populations and study designs. In particular, investigators of pragmatic trial designs, where trials are occurring within the context of clinical care, have little guidance as to the potential benefit, as well as the appropriate content and method of distribution, for lay summaries.…”