Development of an International COVID-19 Specific Quality of Life Questionnaire, Phase III. The OSLO COVID-19 QLQ

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19, Patient Reported Outcome Measures, Quality of Life
• Intervention / Treatment: Other: No intervention. Method study. Psychometric testing

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

• Study Type: Observational
• Enrollment (Actual): 371

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, N-0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To ensure content validity of the final questionnaire, the participants will be recruited according to specified recruitment matrices based on countries, language groups, age, gender, hospitalisation status, disease status and comorbidity.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validated COVID-19 specific questionnaire	Instrument that can be used in international intervention and observational studies on patients with COVID-19 disease	6 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: European Organisation for Research and Treatment of Cancer - EORTC; University of Southampton; Haukeland University Hospital; Medical University Innsbruck; Johannes Gutenberg University Mainz; Skane University Hospital; Komfo Anokye Teaching Hospital; Servicio de Navarro de Salud; University of the East Ramon Magsaysay Memorial Medical Center; Sumandeep Vidyapeeth; Birzeit University; National Centre for Infectious Diseases

Publications and helpful links

General Publications

• Amdal CD, Falk RS, Singer S, Pe M, Piccinin C, Bottomley A, Appiah LT, Arraras JI, Bayer O, Buanes EA, Darlington AS, Arbanas GD, Hofso K, Holzner B, Sahlstrand-Johnson P, Kulis D, Parmar G, Rmeileh NMEA, Schranz M, Sodergren S, Bjordal K. A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire. Qual Life Res. 2023 Feb;32(2):447-459. doi: 10.1007/s11136-022-03272-2. Epub 2022 Oct 23.

Helpful Links

• The questionnaire is available at Mapi Research Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: REK Norway: 171640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No