Decision 2 Lawford 2023
The University of MelbourneDataset description
Demographic, baseline and follow-up data from the "Decision 2" trial. 556 participants aged over 45 years with activity-related knee joint pain. Participants were randomized to a control condition, where they received currently available osteoarthritis information with pathoanatomical content or an experimental condition, where they received the same osteoarthritis information but without pathoanatomical content. Primary outcomes were participants' beliefs about the need for x-ray to confirm diagnosis and joint replacement surgery in the future. All data presented in the results paper (J Orthop Sports Phys Ther. 2023;53(4):1-15) available in XLSX format.Identifiers
Source Study
Trial acronym
Not available
Trial ID
ACTRN12622000630718
Purpose
Educational / counselling / training
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Dr Belinda Lawford
Brief Summary
We are conducting a trial to evaluate whether the removal of pathoanatomically-based biological information about knee osteoarthritis from a patient information pamphlet changes consumer management beliefs, compared to a standard information pamphlet that includes pathoanatomical information. The entire trial will be administered in one single online survey. Participants will initially complete screening questions within the survey to determine eligibility. Eligible participants will then comple .... Read more
Key Inclusion Criteria
Participants will be eligible for the study if they meet the following inclusion criteria: i) Aged 45 years or over; ii) Have, or have not, experienced any activity-related knee joint pain in the past 3 months; iii) Currently living in Australia.
Key Exclusion Criteria
i) Inability to understand or read English; ii) Have had a joint replacement in any of their knee joints .
Can healthy volunteers participate?
Yes
Population
Sample Size 556
Min. age 45 Years
Max. age No limit
Sex Both males and females
Condition category osteoarthritis
Condition code Musculoskeletal
Intervention
Intervention code Treatment: Other
Participants in the Experimental group will be asked to read an approx. 1-page digital information pamphlet about osteoarthritis that was created by the research team based on the content that is currently provided on international osteoarthritis consumer organisation websites. The content will be a similar to that contained in the Control group, but all pathoanatomical information and terminology will be removed. To develop this information sheet, the researchers reviewed the Control group info .... Read more
Comparison
Control group Active
Participants will be asked to read an approx. 1-page digital information pamphlet about osteoarthritis that was created by the research team based on the content that is currently provided on international osteoarthritis consumer organisation websites.
Outcomes
Outcome: If you were told by your doctor that you had knee osteoarthritis, would you think an x-ray is necessary to confirm the diagnosis? 11-point Numeric Rating Scale (NRS) ranging from 0=definitely unnecessary to 10=definitely necessaryTimepoint: Immediately before and after the intervention (as part of the same online survey)
Outcome: If you were told by your doctor that you had knee osteoarthritis, would you think joint replacement surgery (to replace the affected joint with an artificial joint) is necessary for your knee at some stage? 11-point NRS ranging from 0=definitely unnecessary to 10=definitely necessary Timepoint: Immediately before and after the intervention (as part of the same online survey)
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All data presented in the results paper (JOSPT. DOI: 10.2519/jospt.2022.11618) available in XLSX format.
When will data be available?
12-12-2022 to 12-12-2037 (a period of 15 years from publication)
Available to whom?
Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.