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Trial registered on ANZCTR


Registration number
ACTRN12619001381178
Ethics application status
Approved
Date submitted
8/09/2019
Date registered
10/10/2019
Date last updated
10/10/2019
Date data sharing statement initially provided
10/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validity of retrospective measurement of self-reported health status
Scientific title
Validity of retrospective measurement of self-reported health status in elective orthopaedic patients
Secondary ID [1] 299215 0
Nil known
Universal Trial Number (UTN)
U1111-1239-8509
Trial acronym
(Nil)
Linked study record
(Nil)

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing elective knee replacements 314334 0
Patients undergoing elective hip replacements 314626 0
Condition category
Condition code
Musculoskeletal 312679 312679 0 0
Osteoarthritis
Musculoskeletal 312798 312798 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The condition being observed was health related quality of life (HRQOL). Patients undergoing elective hip or knee replacement surgery were prospectively assessed using the EQ-5D-5L two weeks prior to their surgery. HRQOL was assessed again following the patients surgery but prior to discharge from hospital (i.e. within four days post-surgery), retrospective of two weeks prior to their surgery. The prospective and retrospective measurements were assessed for agreement.
Intervention code [1] 315514 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321329 0
Prospective and retrospective measurements of HRQOL, using the EQ-5D-5L were assessed for agreement. The EQ-5D-5L produces seven outcomes, five domain scores (categorical), an EQ-Index score (continuous) and an EQ-VAS score (continuous). The five paired categorical variables were assessed for agreement and were assessed for test-retest reliability using ICC. The two paired continuous variables were assessed for agreement using Lin concordance and by inspecting Bland-Altman plots.
Timepoint [1] 321329 0
Test-retest of prospective scores and restrospective scores measured approximately two weeks apart.
Secondary outcome [1] 374683 0
(Nil)
Timepoint [1] 374683 0
(Nil)

Eligibility
Key inclusion criteria
Patients were eligible for inclusion if they were
(a) aged 18 years and older, and
(b) presented for an elective hip or knee arthroplasty (e.g. total hip replacement or, knee replacement including bilateral and unicompartmental knee replacement).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they were
(a) unable to give consent because they were cognitively impaired or not proficient in English,
(b) unable to be contacted by telephone because they were hearing impaired or did not own a phone, or
(c) unsuitable to be assessed prospectively because their planned date of operation was within 10 days of presentation or they planned on being overseas during the prospective period.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
A sample size of 77 was determined using Zou’s (2012) sample size calculation incorporating assurance probability. A sample size of 77 ensured a 90% assurance probability given the half width of a 95% two-sided confidence interval for a correlation or concordance of 0.8.
The retrospective EQ-5D-5L measurements were compared with prospective measurements; the EQ-5D-5L produces seven separate outcomes (5 domain scores, an index score and a VAS score) and each prospective outcome was paired with its retrospective outcome and tested for correlation. The five domain scores were assessed for intra-class correlation (ICC). The domain scores were then converted to an index score using a scoring algorithm estimated from a sample of the United Kingdom adult general population, using an EQ-5D-5L calculator. The calculator was developed by Sheffield Hallam University on behalf of The Chartered Society of Physiotherapy (UK) in 2011. The purpose of the tool is to enable illustration of change in quality of life as a result of physiotherapy interventions. However, in this instance, we used the tool to pair prospective and retrospective HRQoL scores and to display the distribution of change in domains scores. The prospective index scores and VAS scores were correlated with the retrospective scores. Agreement was assessed for the continuous variables (EQ-index and EQ-VAS scores). Bland-Altman plots were made with 95% limits of agreement and Lin’s concordance correlation coefficient (CCC) was calculated. To interpret the results for correlation and for agreement, we used benchmarks defined by Cicchetti (1994), whereby 0.21 to 0.4 represented ‘fair’, 0.41-0.60 was ‘moderate’, 0.61-0.80 was ‘substantial’ and 0.81-1.00 was ‘almost perfect’ reliability.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/09/2017
Date of last participant enrolment
Anticipated
Actual
28/09/2018
Date of last data collection
Anticipated
Actual
28/09/2018
Sample size
Target
77
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14752 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 27794 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 303757 0
Self funded/Unfunded
Name [1] 303757 0
(unfunded)
Country [1] 303757 0
Primary sponsor type
Hospital
Name
The Sutherland Hospital
Address
The Sutherland Hospital
Corner Kingsway and Kareena Rd
Caringbah 2229 NSW
Country
Australia
Secondary sponsor category [1] 303876 0
University
Name [1] 303876 0
UNSW
Address [1] 303876 0
The University of New South Wales Kensington NSW 2052.
Country [1] 303876 0
Australia
Secondary sponsor category [2] 303973 0
University
Name [2] 303973 0
The Ingham Institute for Applied Medical Research
Address [2] 303973 0
1 Campbell St, Liverpool NSW 2170
Country [2] 303973 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304279 0
South Eastern Sydney Local Health District (SESLHD) Human Research Ethics Committee
Ethics committee address [1] 304279 0
Research Support Office
Room G71, East Wing
Prince of Wales Hospital
Corner High and Avoca Streets
Randwick 2031 NSW
Ethics committee country [1] 304279 0
Australia
Date submitted for ethics approval [1] 304279 0
08/07/2017
Approval date [1] 304279 0
01/09/2017
Ethics approval number [1] 304279 0
17/183 (LNR/17/POWH/384)

Summary
Brief summary
Introduction: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patient-reported HRQoL before and after an intervening health event (major elective orthopaedic surgery).
Method: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at two weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and the EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson’s correlation. Agreement was tested in the continuous variables using Lin’s coefficient of concordance (pc) and inspection of Bland-Altman plots.
Trial website
(Nil)
Trial related presentations / publications
(Nil)
Public notes
(Nil)

Contacts
Principal investigator
Name 96374 0
Prof Ian Harris
Address 96374 0
Whitlam Orthopaedic Research Centre
Level 2, Ingham Institute for Applied Medical Research
1 Campbell St
Liverpool
Sydney, NSW, AUS 2170
Country 96374 0
Australia
Phone 96374 0
+61 411816139
Fax 96374 0
Email 96374 0
ianharris@unsw.edu.au
Contact person for public queries
Name 96375 0
Andrew Lawson
Address 96375 0
Whitlam Orthopaedic Research Centre
Level 2, Ingham Institute for Applied Medical Research
1 Campbell St
Liverpool
Sydney, NSW, AUS 2170
Country 96375 0
Australia
Phone 96375 0
+61 411816139
Fax 96375 0
Email 96375 0
aalawson@tpg.com.au
Contact person for scientific queries
Name 96376 0
Andrew Lawson
Address 96376 0
Whitlam Orthopaedic Research Centre
Level 2, Ingham Institute for Applied Medical Research
1 Campbell St
Liverpool
Sydney, NSW, AUS 2170
Country 96376 0
Australia
Phone 96376 0
+61 411816139
Fax 96376 0
Email 96376 0
aalawson@tpg.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The corresponding investigator can be contacted for access to all of deidentified individual participant data collected during the study.
When will data be available (start and end dates)?
8th September, 2019 onwards. No end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
The corresponding investigator can be contacted for access to deidentified study data. Andrew Lawson aalawson@tpg.com.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4639Study protocol  aalawson@tpg.com.au
4640Informed consent form  aalawson@tpg.com.au
4641Ethical approval  aalawson@tpg.com.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.