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

NCT ID: NCT07087132

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-07-31

Brief Summary

Translation and adaption to a Danish context of the family satisfaction questionnaire FS-ICU-24R. Furthermore, the study will test if the questionnaire adequately measures family satisfaction and is stable over time.

At least 250 relatives of patients, who have been admitted to the intensive care unit at least 24 hours will be included. Relatives will be recruited, when the patients discharge is coming close, i.e. within days. All included relatives will receive the questionnaire on e-mail one month after they registered for the study. Participants will be prompted twice, if they not respond.

After completing the questionnaire once, participants will be asked to complete it a second time after 14 days. The aim is to include at least 50 relatives in this group.

To understand if the questionnaire is measuring family satisfaction, the study will compare the answers to FS-ICU-24R with a score of 1-10 of General satisfaction with the patients care, General satisfaction with information and General satisfaction with decision making. Stability over time will be assessed by comparing responses between first and second time, participants fill out the questionnaire.

Participation will be voluntary and all participants will recieve written and oral information before registering for the study. The participants will register for the study by entering their e-mail into a secure on-line platform.

Detailed Description

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.

Conditions

Family Satisfaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Relatives of ICU patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Relative or close friend to an adult patient admitted to the intensive care unit for at least 24 hours.

Exclusion Criteria

• Persons with cognitive deficits that makes them unable to give informed consent. Persons who cannot read Danish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Hospitalsenheden Vest

OTHER

Sponsor Role: lead

Responsible Party

Anne Højager Nielsen

Head of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Gødstrup Hospital

Herning, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anne H Nielsen, Ph.D. MCN, CCRN

Role: CONTACT

annsve@rm.dk

4520158924

Facility Contacts

Anne Ågård, Ph.D.

Role: primary

anne.aagaard@skejby.rm.dk

4521625484

Anne H Nielsen, Ph.D, MCN, CCRN

Role: primary

annsve@rm.dk

4520158924

References

Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.

Reference Type: BACKGROUND

PMID: 17133189 (View on PubMed)

Jensen HI, Downey L, Koopmans M, Curtis JR, Engelberg RA, Gerritsen RT. Family ratings of ICU care. Is there concordance within families? J Crit Care. 2020 Feb;55:108-115. doi: 10.1016/j.jcrc.2019.10.011. Epub 2019 Oct 31.

Reference Type: BACKGROUND

PMID: 31715527 (View on PubMed)

Harrison DA, Ferrando-Vivas P, Wright SE, McColl E, Heyland DK, Rowan KM; Family-Reported Experiences Evaluation Study Investigators. Psychometric assessment of the Family Satisfaction in the Intensive Care Unit questionnaire in the United Kingdom. J Crit Care. 2017 Apr;38:346-350. doi: 10.1016/j.jcrc.2016.10.023. Epub 2016 Nov 5.

Reference Type: BACKGROUND

PMID: 27914907 (View on PubMed)

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

Reference Type: BACKGROUND

PMID: 31078660 (View on PubMed)

Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.

Reference Type: BACKGROUND

PMID: 18352969 (View on PubMed)

De Vet, H. C., Terwee, C. B., Mokkink, L. B., Knol, D. L. (2011). Measurement in medicine : a practical guide. Cambridge University Press.

Reference Type: BACKGROUND

Cha ES, Kim KH, Erlen JA. Translation of scales in cross-cultural research: issues and techniques. J Adv Nurs. 2007 May;58(4):386-95. doi: 10.1111/j.1365-2648.2007.04242.x. Epub 2007 Apr 17.

Reference Type: BACKGROUND

PMID: 17442038 (View on PubMed)

Nielsen AH, Agard AS, Collet MO, Brix LD. Translation and Validation of the Canadian ICU Family Satisfaction Questionnaire (FS-ICU-24R) to Danish-A Protocol. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70123. doi: 10.1111/aas.70123.

Reference Type: DERIVED

PMID: 40922387 (View on PubMed)

Other Identifiers

1-16-02-51-24

Identifier Type: -

Identifier Source: org_study_id