Official Title
Development of an International Questionnaire to Assess Patient-reported Quality of Life Related to COVID-19 Disease, the Oslo COVID-19 Quality of Life Questionnaire (QLQ) - ## © Phase III of Questionnaire Development
Brief Summary

Purpose: to develop an international validated patient-reported outcome measure for COVID-19 patients according to international guidelines. In this phase III of the project, the preliminary questionnaire of 80 items will be tested. It has been developed based on literature review and interviews with health care professionals and patients (phase I-II). In Phase III A patients will fill in the questionnaire followed by interviews on relevance, importance and wording of the questionnaire In Phase III B patients will fill in the questionnaire and an debriefing questionnaire. We will do explorative psychometric analyses.

Detailed Description

This project aim to develop an international validated patient-reported outcome measure for
COVID-19 patients according to international guidelines. The Phase I and II of this
development process have been finalized. Based on a systematic literature review , interviews
with 44 health-care professionals and 52 patients in 6-7 countries a final list of 80
questions, the preliminary Oslo COVID-19 QLQ - PW80 ©, is ready to be tested in the current
Phase III of the development process.

The objectives of the phase III are:

- In a limited patient group, to check that the items make sense to the target population,
that the phrasing and sequence of questions is acceptable, that there are no missing
issues and that none of the questions are confusing and/or offensive (Phase IIIA).

- In addition, in a larger patient group, to test hypothesized subscales for psychometric
properties including reliability, prevalence and variance (e.g. Cronbach's alpha
coefficient and correlation-based methods) (Phase IIIB).

The end-product, the international COVID-19- specific questionnaire, will be a
psychometrically robust patient-reported outcome measure (PROM) to assess HRQoL in patients
with or after COVID-19 disease

Unknown status
Covid19, Patient Reported Outcome Measures, Quality of Life

Other: No intervention. Method study. Psychometric testing

Patients will fill in the questionnaire followed by an interview (phase IIIA) or a debriefing questionnaire (Phase IIIB)

Eligibility Criteria

Inclusion Criteria:

- Patients with verified SARS-CoV-2 infection (positive test according to local/national
standards)

- Patients with active or previous symptomatic COVID-19 disease

- In-patients in hospitals and nursing homes or out-patients in hospitals or patients
discharged from institutions to their home/covid-19 centres or patients staying at
home/covid-19 centres during the course of the disease

- Patients aged 18 years and older

- Ability to read and comprehend the process and study documents as judged by the
investigator

- Written informed consent

Exclusion Criteria:

- Patients in intensive care units (can be recruited after they have been dismissed)

- Inability to read and comprehend the process and study documents as judged by the
investigator

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Norway
Locations

Oslo University Hospital
Oslo, Norway

Investigator: Cecilie D Amdal, PhD
Contact: +4791517199
cecia@ous-hf.no

Contacts

Cecilie D Amdal, PhD
+4791517199
cecia@ous-hf.no

Kristin Bjordal, PhD
kbj@ous-hf.no

Oslo University Hospital
NCT Number
MeSH Terms
COVID-19