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. Author manuscript; available in PMC: 2018 Nov 1.
Published in final edited form as: Contemp Clin Trials. 2017 Aug 24;62:121–129. doi: 10.1016/j.cct.2017.08.016

Table 1.

Operationalized Definition of Adverse Event

Form Item Question Answer
Satisfaction Questionnaire 5 It was too much to handle Agree/Strongly Agree
Satisfaction Questionnaire 7 It was harmful Agree/Strongly Agree
Satisfaction Questionnaire 14 Qualitative statement Similar negative statement as above
Satisfaction Questionnaire 1 It was useful Disagree/Strongly Disagree
Satisfaction Questionnaire 2 It was helpful Disagree/Strongly Disagree
Satisfaction Questionnaire 6 I feel satisfied Disagree/Strongly Disagree
Satisfaction Questionnaire 11 I felt courageous Disagree/Strongly Disagree
Satisfaction Questionnaire 13 It was worthwhile Disagree/Strongly Disagree

Note: An adverse event occurs when a participant disagrees or strongly disagrees with items 1, 2, 6, 11, and 13 AND agrees or strongly agrees with either item 5, 7 or remarks a similar sentiment in the qualitative section.