Response Rates and Reliability
The general characteristics of the participants are shown in Figure 1.
81 out of 86 participants responded to the survey (94% response rate) with a completion ratio of the first 13 questions of 96%.
Compliance is to be considered sufficient,
since there has been no incomplete questionnaire (more than 50% missing values).
58 participants responded to the initial delivery of the questionnaire within 12±6 days.
24 participants responded to the second delivery of the questionnaire and/or the telephone reminder within 24±10 days.
In the retest round,
55 participants returned the questionnaire (32% less than in the initial batch).
Response time was 13±7 days.
An agreement of 100% was achieved between the participants’ reply in the survey and the GNC database with the filter question whether the responder previously received an IF report.
Due to high rate of missing values in the retest phase the calculated agreement-scores show diverse strengths of correlation.
Study Evaluation
More than 95% of all participants perceived the duration of the wbMRI-exam,
which takes approx.
1 hour,
as not too long and therefore as tolerable.
92 % were satisfied with the information given prior to the wbMRI examination.
Moreover,
about 95% would consider participating in a follow-up MRI examination.
Almost all participants (95%) consider it very important to receive notification of IFs,
46% of them would not have even taken part,
if the prospect of receiving IF notification had not been given.
The emotional stress experienced while waiting for a result letter was estimated to severe by 9% of the responders and mild grade by 34%,
while 54% experienced no or minimal stress (Figure 2).
Participants were asked what kind of findings they would like to be informed about in general.
Almost half of them would like to be informed about all kind of findings,
regardless of their clinical relevance.
Only 15% of all responders would prefer to be informed only about medical conditions,
which are treatable.
During the informed consent discussion,
all participants were explained,
that a notification of an IF is to be expected only if a finding is considered to be clinically relevant or life-threatening.
However,
70% of all responders - without difference regarding the presence of IF - seemed not to be aware of this principle of IF communication of the GNC wbMRI study.
IF Reporting and Follow-Up
Out of 86 participants who got the questionnaire,
38 participants had a prior disclosure of 46 IFs in total,
including four IFs that required urgent notification (Figure 3).
Calculated from the participants’ responses based on their subjective retrospective estimations,
the average delivery time of the notification letters was 3.6±2 weeks,
in case of the 4 urgent notifications 2 weeks was reported.
Nevertheless,
according to the GNC database notification letters were sent out within 3.5±0.3 days.
The phrasing of the reports was rated as well to understand by most participants (97% well or very well).
In a single yes/no question on the subjective estimation of potential benefits from IF disclosure,
more than half of the responders (55%) reported,
that IF disclosure had a positive influence on their health status.
81% of all disclosed IFs were not previously known to the participant.
19% (7 cases) of all disclosed IFs were previously known to the participant.
Concerning the disclosed IFs,
most participants consulted a general physician (68%) or another specialist (58%).
Interestingly,
26% consulted their family members or found the World Wide Web useful as well.
For further examination,
physicians were consulted in 86 % of cases (Figure 2).
An adverse event during further work-up was reported in one case,
an allergic reaction to CT contrast medium.
Only one participant reported not to have taken any effort for further work-up the disclosed IF.