Psychometric Properties of the Short Form 12-item (SF-12) Health Questionnaire in Individuals With Knee Osteoarthritis (SF-12)

August 15, 2023 updated by: Meltem Meran Çağlar

Validity, Reliability, and Smallest Detectable Change of the Short Form 12-Item (SF-12) Health Survey in Individuals With Knee Osteoarthritis: A Cross-sectional Study

Knee Osteoarthritis (OA) is one of the most common joint diseases with chronic low-severity inflammation. 80% of individuals with knee OA have limited movements; It was found that 25% of them could not do their daily work. In addition, it has been shown that the quality of life of individuals with OA is lower compared to healthy individuals. This showed that measuring and reporting quality of life should be mandatory in clinical studies conducted in individuals with knee OA. It was stated that the most frequently used general scales in the evaluation of quality of life in these individuals were SF-36 or SF-12. It takes a long time for the SF-36 to be filled by individuals, which creates a disadvantage for both patients and clinicians. Developed as a shorter alternative to SF-36, SF-12 has also been shown to give similar results to SF-36 in individuals with knee OA who have undergone total knee arthroplasty. However, the psychometric properties of SF-12 in individuals with knee OA have not been examined. The purpose of this study is to examine whether SF-12 is valid and reliable in individuals with knee OA and to determine the minimum detectable change (MDC) value.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Forty volunteers aged 40 years and older diagnosed with knee OA will be included in the study. First, individuals will be informed about the study in detail, and signed informed consent form will be obtained from individuals who agree to participate in the study. First of all, the demographic information of the individuals will be recorded. Chronic diseases and continuous drug use will be questioned. Individuals' quality of life will be evaluated with the SF-12 and SF-36 scales, and their functional status will be evaluated with the WOMAC score. All scales will be filled once, but the second evaluation for the test-retest reliability (intra-rater reliability) of the SF-12 scale will be repeated one week later. In our study, the sample size was determined by using a web-based sample size calculation application specially developed for reliability-validity studies. In this application, hypothesis testing was performed according to ICC values. The minimum acceptable reliability (ICC) was 0.65 and the expected reliability from the study was 0.85. When the significance level of the study (α) was determined as 0.05 and the power of the study (1-β) was determined as 80%, and considering the probability that 10% of the individuals participating in the study could exit the study, it was found that the minimum sample size to be taken for the study should be 40 people. Jamovi 2.3.28 program will be used in the statistical analysis of the data. Variables determined by measurement will be expressed as mean ± standard deviation (X ± SD), percent (%) will be calculated for variables determined by counting. The normal distribution will be evaluated by examining both visually (Histogram and Q-Q plots) and statistical techniques (Kolmogorov Smirnov test, Skewness and Kurtosis values). Criterion-releated validity of SF-12 will be evaluated by its subtype, concurrent validity, and its correlation with WOMAC and SF-36 scales will be evaluated. Pearson correlation test will be applied when the correlation normal distribution conditions are met, and Spearman correlation test will be applied if not. Correlation coefficient level will be considered as <0.3 low, 0.3- 0.5 medium, >0.5 strong. In the reliability test of the SF-12 scale, test-re-test will be applied for the stability of the scale, and intra-class correlational coefficients (ICC) will be calculated. ICC values of 0.5-0.75 will indicate moderate reliability, 0.75-0.9 good reliability, and >0.9 excellent reliability. In order to determine the internal consistency of the scale, internal consistency coefficients (Cronbach's alpha) will be calculated. It will be at an acceptable level when Cronbach's alpha is >0.7. Absolute reliability will be determined by calculating the standard error of measurement (SEM) to ensure the accuracy of the measurement. The SEM will be used to calculate the smallest detectable change at the 95% confidence level (MDC95) and will be calculated as: MDC95=SEM × 1.95 × √2. In all statistics, the "p" significance value will be taken as 0.05.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey
        • Meltem Meran Çağlar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The research will be carried out in Aydın ARSLAN Orthopedics and Traumatology Clinic, which is connected to the province of Istanbul, in individuals aged 40 and over who are diagnosed with knee osteoarthritis.

Description

Inclusion Criteria:

  • 40 years and older,
  • Radiological and clinical diagnosis of knee OA,
  • Volunteering to participate in the study,
  • Ability to read and write

Exclusion Criteria:

  • Having problems with cooperation or cognitive impairment,
  • Previous total knee arthroplasty surgery,
  • Presence of neurodegenerative or neuromuscular disease,
  • Psychological disorders,
  • Presence of depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Status Questionnaire (Short Form-SF-36)
Time Frame: Evaluation data will be collected within six month.
The SF-36 is a widely used self-reported general health status questionnaire that measures eight dimensions of health status. Physical functioning, role restrictions due to physical health problems, bodily pain, social functionality, general mental health, role restrictions due to emotional problems, vitality and general health perceptions. It is a form that evaluates the last 4 weeks. While these eight sub-dimensions can be scored separately, the physical and mental component summary score (FCS and MCS score, respectively; Physical and Mental Component Summary Scores) can be obtained by weighing them and providing a general assessment of physical and mental health.
Evaluation data will be collected within six month.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Evaluation data will be collected within six month.
WOMAC will be used to assess patients' knee pain, joint stiffness and function. WOMAC is a disease-specific health status measure frequently used in patients with knee and hip OA. WOMAC consists of 24 questions, 5 questions in the pain section, 2 questions in the stiffness section, and 17 questions in the function section.
Evaluation data will be collected within six month.
Short Form 12-Item (SF-12) Health Survey
Time Frame: Evaluation data will be collected within six month.
The 12-item short form health questionnaire (SF-12) is a measure of physical and mental health. It has been reported that SF-12, which was created from the original form, SF-36, is more advantageous in terms of ease of application and shorter completion time. While the PCS-12 score is obtained from the sub-dimensions of general health, physical functionality, physical role and body pain, the MCS-12 score is obtained from the sub-dimensions of social functionality, emotional role, mental health and energy.
Evaluation data will be collected within six month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meltem Meran Çağlar

Investigators

  • Study Chair: Meltem Meran Çağlar, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedipolU

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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