Translation and Validation of the FS-ICU-24R Into Danish

Method Translation and adaption: The FS-ICU-24R (the family satisfaction with the ICU 24 item questionnarie) will be translated into the Danish language in agreement with one of the original authors, Dr. Daren Heyland. The initial forward translations will be produced by four bilingual nurses all Danish native speakers. Afterwards, the translations will be discussed with two researchers and a pooled version will be produced. Translation of key terms will be thoroughly discussed before deciding on the most appropriate wording. The investigators will opt for a conceptually and culturally sound translation rather than a literal translation, which will be acceptable to the users of the instrument: relatives of ICU patients. Back translation will be undertaken by a bi-lingual nurse, who will be blinded to the original version at all stages of the translation process. The research group will compare the backward version with the source instrument and a second version of the questionnaire will be produced. The process will be repeated to resolve minor discrepancies as needed.

Face and content validity: The Danish version will be presented to 4-6 relatives, who will be interviewed about their perceptions and understanding of the questionnaire. Following the administration of the instrument, all relatives will be interviewed. For each item, relatives will be asked to describe in their own words what they think the item is about and how they chose their answer. Furthermore, if an item is difficult to understand or ambiguous, relatives will be asked to provide alternative wording. Notes and comments made during the interviews on the questionnaire items will be discussed by the researchers before a final version of the questionnaire will be produced. One of the original authors, Dr. Daren Heyland, will approve of the final back translation.

Psychometric testing of FS-ICU-24R in a prospective cohort of Danish ICU relatives:

Recruitment procedure: Relatives will be informed in person about the study while in the ICU. If relatives agree to participate, they must register for the study using a smartphone and a QR code. If a participant prefers to complete the questionnaire on paper, a package containing the questionnaire, information about the study and a return envelope will be supplied with instructions on when to fill in the questionnaire and how to return it. The site will only need to register how many packages have been distributed.

Recruitment of participants to the subgroup test-re-test analysis: When completing the questionnaire in REDCap relatives will be asked to participate a second time for a test-re-test analysis.

Sample size: The reseach group aim to include at least 250 relatives. Several family members from the same family may be included. For criterion and construct validation it is recommended to include more than 100 patients. For confirmatory factor analysis, it is recommended to include 4-10 respondents per item. As the SF-ICU-24R has 26 items and 3 items for bereaved relatives only, at least 250 relatives must be included. Although relatives of the same patient may have some shared experiences, a validation study of the EuroQ2 instrument, which contains many of the same questions, showed that identical ratings only occurred in 28-59% of families. This study supports that relatives' experiences from the same patient trajectory can be surprisingly different. A subgroup of at least 50 relatives will be invited to complete the questionnaire a second time to explore test-retest validity.

Data: In the beginning of the questionnaire, participants will be asked to rate their overall emotional wellbeing, overall satisfaction with care, overall satisfaction with information and overall satisfaction with decision making on Likert scales 1-10 (1= worst imaginable, 10=best imaginable). P participants will then complete the Danish version of the FS-ICU-24R. After each section (satisfaction with care, satisfaction with information, satisfaction with decision making, and bereavement), the participants will be able to make comment in free text. Finally, the participants will be asked to provide background information on sex, age, education, and relationship with the patient.

Data collection: The questionnaire will be distributed by email through the secure web application REDCap hosted by Aarhus University and all data will be stored in REDCap at Aarhus University. For participants preferring to respond in paper, the study group will manually enter mailed responses into REDCap. Paper questionnaires will be coded to identify the issuing ICU.