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Three of the PROs involved patients in concept elicitation/item generation and in the evaluation of items through a cognitive debrief methodology or similar approach: the EFA, LSSS and SHE.
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Participants completed and reviewed the PEESS™ version 2.0 preliminary draft derived from the focus interviews and provided feedback utilizing the previously described respondent debriefing methodology [ 13].
Participants completed the draft PedsQL™ EoE Module instrument and then provided feedback employing the previously described respondent debriefing methodology (see Table 1) [ 16, 17, 21].
In the current investigation, utilizing the respondent debriefing methodology, cognitive interviewing was conducted individually with pediatric patients with EoE and their parents on each newly developed item.
Utilizing the cognitive debriefing methodology in the current study, the semi-structured question format allowed patients and families the opportunity to explain in their own words the impact of EoE on their family and to achieve content saturation prior to finalizing the items.
In addition, we used peer debriefing within a grounded theory methodology seminar and solicited feedback from health professionals at palliative care conferences.
The cognitive debriefing protocol will be developed based on standard methodology building on methods used for cognitive debriefing of conjoint analysis instruments.
Most of the PROs (n = 14) had partially involved patients in the development of the instrument, in most cases either concept elicitation OR cognitive debrief were undertaken, but not both methodologies.
All participants were provided with a debriefing as to the purpose of the study and the methodology employed at the conclusion of their interview.
To emphasize the formative aspect of the methodology, each direct observation experience is followed by a debriefing session, which incorporates both (a) review of the behaviors observed by faculty and (b) reflection about the encounter experience.
The translation followed an internationally accepted methodology into 3 steps: forward translation, backward translation, and patients' cognitive debriefing.
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