Evaluation of Health Related Quality of Life and Patient Adherence in Case of Hungarian Patients Affected by Osteoarthritis

Translation and Cross-cultural adaptation process of the Osteoarthritis Knee and Hip Quality of Life questionnaire. According to granted guidelines, shared by the developer of the questionnaire, the study was conducted among Hungarian patients affected by osteoarthrosis.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis

Detailed Description

This prospective study was performed among patients diagnosed - by the doctors acting as the expert panel of this study - with OA of the lower limb. The recruitment period was: June 2017 and November 2017, in six hospitals situated in six different geographical regions of Hungary. The participating hospitals were selected in a way to represent different geographic and cultural areas of the country; the patients were selected randomly by the doctors of the given sites. The process was conducted with the contribution of: (1) Translation committee (4 members), (2) Our research team, as moderator (4 members), (3) Expert panel (6 doctors professors of the study sites: orthopaedists, rheumatologists, musculoskeletal rehabilitation doctors). The used instruments were for the validation process: Short version of World Health Organization Quality of life questionnaire (WHOQoL-BREF), EuroQuality of Life - 5-dimension questionnaire as generic quality of life measurement tools (EQ-5D - VAS). In addiction 99 patients filled the questionnaires in an appropriate way. The results were evaluated by 23.0 version of SPSS program.

• Study Type: Observational
• Enrollment (Actual): 99

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Both sex, above 18 years old

Description

Inclusion Criteria:

• age over 18 years
• clinically/doctor diagnosed knee and/or hip osteoarthritis
• native Hungarian language
• ability of self-filling and completely filled patient data sheet.

Exclusion Criteria:

• age under 18 years
• other type of OA osteoarthritis
• psychiatric disorders
• surgeries within 1 month
• incapable of filling out the forms/tools

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity and Reliability of the translated and adapated questionnaire	The translated questionnaire was tested among affected patients. First of all the face and content validity were evaluated, namely how understandable is the translated questionnaire for patients with Hungarian native language. How many percent of the items were no answered. According to the shared guideline if more then 5 % of an item is not answered should be selected from the final version of the questionnaire - with the exception of the items based on sexual life(3 items). The research team noticed that face and content validity were adequate.	17 months

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 24950-3/2016/EKU

Drug and device information, study documents

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