There has been growing interest in providing clinical trial participants with study results yet only limited information exists regarding the process and impact of sharing results. We sought to evaluate patient perceptions of how results had been shared from a large randomized cooperative group trial, and the impact of learning results.
A subset of women who participated in NCCTG 9831 (A Phase III Trial of Adjuvant Chemotherapy with or without Trastuzumab for Women with HER2-positive Breast Cancer) were mailed surveys after the preliminary study results were released to the public and mailed to participants.
One hundred and 67 of 228 surveys sent (73%) were returned; 61% reported receiving trastuzumab on study; 4% reported recurrent disease. Ninety-five percent of participants were glad they received results; 81% were satisfied with how results were shared; 23% were more anxious after learning the results. Sixty-nine percent correctly interpreted the results. Logistic regression revealed that satisfaction with the process of receiving results was associated with satisfaction with treatment (P = 0.04), and increased anxiety was associated with dissatisfaction with treatment (0.02), incorrect interpretation of results (0.04), and not having received trastuzumab (P < 0.0001).
Sharing results directly with study participants is met with overwhelmingly favorable responses from patients, although some may not initially understand the findings. The potential for increased anxiety should be considered, and psychosocial support may be required by some. A plan to share results should be routinely and prospectively considered in the design of cancer clinical trials.
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"However, aggregate reports may dilute the value of results because participants will be unsure of the findings' individual significance (Dixon-Woods et al., 2006). Disclosure of summary research results, even those of a serious nature or negative results, has generally not been found to result in adverse psychological impacts in research participants although a subset of participants has experienced negative effects such as feelings of fear, guilt, and anxiety (Bunin et al., 1996; Snowdon et al., 1998; Schulz et al., 2003; Partridge et al., 2005, 2009). Those who support providing participants with the option to learn of their results, either individual or aggregate, argue that it shows respect for participants and re-positions them as active contributors to research studies as opposed to being only a means of accomplishing research (Shalowitz and Miller, 2005; MacNeil and Fernandez, 2006). "
[Show abstract][Hide abstract] ABSTRACT: as genetic and genomic research proliferates, debate has ensued about returning results to participants. In addition to consideration of the benefits and harms to participants, researchers must also consider the logistical and financial feasibility of returning research results. However, little data exist of actual researcher practices.
we conducted an online survey of 446 corresponding authors of genetic/genomic studies conducted in the United States and published in 2006-2007 to assess the frequency with which they considered, offered to, or actually returned research results, what factors influenced these decisions, and the method of communicating results.
the response rate was 24% (105/446). Fifty-four percent of respondents considered the issue of returning research results to participants, 28% offered to return individual research results, and 24% actually returned individual research results. Of those who considered the issue of returning research results during the study planning phase, the most common factors considered were whether research results were deemed clinically useful (18%) and respect for participants (13%). Researchers who had a medical degree and conducted studies on children were significantly more likely to offer to return or actually return individual results compared to those with a Ph.D. only.
we speculate that issues associated with clinical validity and respect for participants dominated concerns of time and expense given the prominent and continuing ethical debates surrounding genetics and genomics research. The substantial number of researchers who did not consider returning research results suggests that researchers and institutional review boards need to devote more attention to a topic about which research participants are interested.
Full-text · Article · Oct 2010 · Genetic Testing and Molecular Biomarkers
[Show abstract][Hide abstract] ABSTRACT: This report contains the findings of a committee charged with reviewing the HIPAA privacy rule and its impact on health research. The committee found that the rule does not adequately protect the privacy of peopleâ€™s personal health information and hinders important health research. It recommends that Congress authorize the development of an entirely new approach to protecting personal health information in research that applies privacy, data security, and accountability standards uniformly to information used in all health-related research regardless of who funds or conducts it.
[Show abstract][Hide abstract] ABSTRACT: DISCLOSURE OF INDIVIDUAL RESEARCH results to research participants has been the subject of professional guidelines as well as scholarly commentary, yet controversy remains. To gather data on participant perspectives, we interviewed 40 individuals from the Durham, North Carolina area about a biorepository consent form and conducted an in-depth analysis of responses to a series of questions concerning access to research results. Cross-cutting themes emerged about (1) the nature of research; (2) the nature of research results; (3) expectations concerning access to research results; and (4) practical issues in providing access to research results. Our findings highlight the importance for sound policy development of soliciting stakeholder input, and exploring the complexities behind their evaluations.
Preview · Article · Sep 2009 · Journal of Empirical Research on Human Research Ethics