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Trial registered on ANZCTR


Registration number
ACTRN12617001595303
Ethics application status
Approved
Date submitted
15/11/2017
Date registered
1/12/2017
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising primary care management of knee osteoarthritis: the PARTNER project
Scientific title
Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: the PARTNER project
Secondary ID [1] 292120 0
NHMRC APP1115720
Universal Trial Number (UTN)
U1111-1197-4809
Trial acronym
PARTNER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 303548 0
Condition category
Condition code
Musculoskeletal 302957 302957 0 0
Osteoarthritis
Public Health 304818 304818 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PARTNER Model of Service Delivery:

The intervention targets both General Practitioners (GPs) and their patients, recruited from the practice’s patient list. GPs in the intervention arm will be provided with training and support to facilitate increased use of effective non-surgical management for their patients with knee osteoarthritis (OA). The enrolled patients are involved in the study for 12-months. Patients of the intervention GPs will receive personalised advice and support to effectively self-manage their knee OA via a centralised service; the PARTNER Care Support Team (PARTNER CST). The patients will have an initial 10 minute visit to their GP for a knee OA focused consultation. Their GP will confirm their OA diagnosis, discuss management options around weight loss, exercise and medications and refer them to the PARTNER CST for ongoing support to manage their knee OA.

The PARTNER CST will be comprised of a multidisciplinary allied health team, sought from a wide range of professions (e.g. physiotherapists, occupational therapists, exercise physiologists, pharmacists, and/or dieticians), who have an interest in supporting effective chronic disease self-management and lifestyle behaviour change. The PARTNER CST staff will receive three days of face-to-face workshops in behaviour change support by HealthChange Australia, and will be required to complete four practice phone calls. Formal feedback will be provided on two of the calls. CST members will be required to complete additional training in evidence-based knee OA management provided by the investigators. Independent learning will be facilitated via an e-learning management system, and include information on evidence based treatments, and a 1-hour webinar practice on how to best explain osteoarthritis to participants. The PARTNER CST will prioritise exercise, weight loss, pain management and other self-management behaviours, and have ongoing support from the trial staff and experts on the research team.

GPs in the control group will receive no intervention and their patients will not have access to the PARTNER CST and thus receive ‘usual care’.

GP intervention details:
GPs in the intervention group will be asked to undertake a range of professional development activities related to best practice management of knee OA prior to seeing patients enrolled in the study. The professional development activities will include:

• A self-audit and feedback activity that asks GPs to reflect on their recent management of patients with knee OA and identify areas for improvement. The self-audit and feedback activity will take approximately 2 hours. It will be administered by the University of Sydney through an online survey and data management system (REDCap) and we will seek accreditation from the Royal Australian College of General Practitioners (RACGP) for professional development.
• An on-line professional development module on evidence-based knee OA diagnosis and treatment developed in collaboration with the RACGP (1 hour).
• An on-line PARTNER specific module that describes the trial (20 min), and offers training on health literacy and motivational interviewing topics (1-2 hours).

These educational activities are based on the NICE Clinical Guidelines for the management of OA, and the Osteoarthritis Research Society International (OARSI) Guidelines. All GPs allocated to the intervention group will be provided with cdmNet software and training by the software developer during a 45 minute video conference or face-to-face workshop. cdmNet is a network of on-line computing services and infrastructure designed to help GPs manage chronic disease.

Patient intervention details:

Once patients are referred to the PARTNER CST, they will be followed up for the remainder of their 12-month study involvement. The PARTNER CST intervention will be delivered remotely via phone, video call, email, post and/or SMS contact as per the patient’s preference. The intervention for the patients will occur with contact at a frequency that suits their needs and preferences (estimated 2-12 contacts per patient). The PARTNER CST will discuss the role of the team, different non-surgical OA management options, and the patient’s priorities and goals. The patient will also be provided with additional OA educational resources developed by the study team and our partner organisations, including a handbook on management of osteoarthritis of the knee, a physiotherapists developed leg strengthening program, links to Arthritis Australia’s OA consumer website ‘myjointpain.org.au’, and a range of other self-monitoring tools. The CST will provide ongoing self-management advice and support, and tailor a care plan aligned to the patient’s individual needs. The patient will be encouraged and supported to undertake the study’s priority activities of leg strengthening, physical activity and weight loss. Eligible patients (BMI 27 or above) will also be given the option to undertake the CSIRO Total Wellbeing Diet (TWD) program which is a 12-week online program, involving tutorials around a healthy diet, two online coaching sessions with an accredited practicing dietitian, unlimited phone support and relevant educational materials . Patients undertaking the TWD program will also continue to be supported by the PARTNER CST throughout their involvement in the weight management program. Secondary issues and additional goals may also be discussed and set if the patient chooses. Referral to online cognitive behavioural therapy (CBT) programs or other external services will be offered if the patient meets pre-determined criteria for stepping up care and/or has identified an issue as a priority for action. These optional CBT programs and services may include pain coping skills (PainCoach), dealing with depression and anxiety (This Way Up), sleep and fatigue management (Shuti), a work productivity consultation with a rehabilitation councillor, or referral to a local health professional to address specific issues.

Process evaluation:

We will undertake a process evaluation using mixed methods to assess intervention fidelity, understand the process of implementation, and identify which interventions have the greatest impact on behavioural change. Behaviour change interventions for the GPs, patients, and the CST will be assessed using self-report questionnaires, qualitative interviews and information collected from our partner organisations who are providing training. Data collected from GPs will include GP consultation behaviours (via surveys at baseline, 6 and 12 months), readiness to implement the proposed treatment and completion of training activities. Patient data will include the Osteoarthritis Quality Indicator Questionnaire (OA-QI), information on referrals and services used (6 and 12 months). Fidelity for the PARTNER CST will involve treatment records audit, consultation behaviours (via surveys). Evaluation of the number and length of CST contacts, treatments recommended and services used will be undertaken at the end of the intervention.

A sub-sample of participants from all groups (GPs, PARTNER CST, staff and patients) will be interviewed for qualitative purposes by members of the study team, and affiliated post-graduate students. The studies will primarily focus on factors affecting implementation, knowledge translation and ongoing stakeholder engagement, scaling up and long-term sustainability of the model. We will use purposive sampling to gain perspectives from different regional and practice-related contexts. Semi-structured interviews will be conducted using thematic and content analysis. They will be conducted over the telephone, audio-recorded and transcribed verbatim by researchers trained in qualitative techniques.
Intervention code [1] 298266 0
Treatment: Other
Intervention code [2] 298267 0
Lifestyle
Intervention code [3] 298268 0
Behaviour
Comparator / control treatment
General Practitioner's Usual Care of Knee Osteoarthritis: GPs in the practices allocated to the control group will manage patients as per their usual care. Management of the patient’s OA is purely at the discretion of the GP, there will be no restrictions on how these patients should be managed. GPs may refer to any third party provider, which may incur additional out-of-pocket expenses for the patient. Patients may attend these services at their own discretion. The GPs in this arm will receive a short introductory presentation on the trial and their involvement. They will not receive any additional education on OA or OA management during their involvement in the trial.
Control group
Active

Outcomes
Primary outcome [1] 302349 0
Change in average pain of the study knee: overall average pain over the past week will be self-reported via a numerical rating scale with terminal descriptors of ‘no pain’ (score 0) and ‘worst pain possible’ (score 10).
Timepoint [1] 302349 0
12 months from their enrollment in the study (completion of baseline survey).
Primary outcome [2] 302350 0
Change in physical function of the study knee: knee function will be measured using the function in daily living subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS questionnaire measures symptoms and functional limitations associated with knee OA. The outcomes are measured using Likert responses scored from 0 to 4. The questions pertain to the previous 7 days.
Timepoint [2] 302350 0
12 months from their enrollment in the study.
Secondary outcome [1] 335623 0
Change in average pain of the study knee: overall average pain over the past week will be self-reported via a numerical rating scale with terminal descriptors of ‘no pain’ (score 0) and ‘worst pain possible’ (score 10).
Timepoint [1] 335623 0
6 months from enrollment in the study.
Secondary outcome [2] 335624 0
Change in physical function of the study knee: knee function will be measured using the function in daily living subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS questionnaire measures symptoms and functional limitations associated with knee OA. The outcomes are measured using Likert responses scored from 0 to 4. The questions pertain to the previous 7 days.
Timepoint [2] 335624 0
6 months from enrollment.
Secondary outcome [3] 335625 0
Change in other OA symptoms of the study knee will be measured using the Symptoms subscale of the KOOS.
Timepoint [3] 335625 0
6 and 12 months from enrollment.
Secondary outcome [4] 335627 0
Change in quality of life will be measured using the Quality of Life subscale of the KOOS.
Timepoint [4] 335627 0
6 and 12 months from enrollment.
Secondary outcome [5] 335628 0
Change in function of the study knee during sport and recreational activities will be measured using the Function (sports and recreational activities) subscale of the KOOS.
Timepoint [5] 335628 0
6 and 12 months from enrollment.
Secondary outcome [6] 335629 0
Change in weight and Body Mass Index (BMI). Patients will be asked to self-report their weight. BMI for these time points will be calculated using baseline height data. Patients will be asked to use the same set of scales to measure their weight for all time points.
Timepoint [6] 335629 0
6 and 12 months from enrollment.
Secondary outcome [7] 335630 0
Change in health-related quality of life will be assessed via the Assessment of Quality of Life (AQoL-8D) instrument. The AQoL is a health-related multi-attribute utility quality of life instruments, initially designed for use in economic evaluation studies. This instrument has 35 items in 8 separately scored dimensions; independent living, relationships, mental health, coping, pain, senses, self-worth and happiness. The questions pertain to the previous 7 days.
Timepoint [7] 335630 0
6 and 12 months from enrollment.
Secondary outcome [8] 335631 0
Change in depression and anxiety (mood) will be measured using the Patient Health Questionnaires (PHQ 9). The PHQ 9 will be used for the baseline and follow-up assessments, and the PHQ2 as a quick screening tool during the intervention. The PHQ 9 is a multi-purpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is used widely for identifying depression in chronic conditions including osteoarthritis. There are 9 questions scored on a 4 point scale (0=not at all, 3=nearly every day). The questions pertain to the previous 14 days. Score responses are normal, mild, moderate, moderately severe, severe and very severe.
Timepoint [8] 335631 0
6 and 12 months from enrollment.
Secondary outcome [9] 335632 0
Sleep impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS™) adult Sleep-Related Impairment Short Form 8a (patient self-report). The tool consists of 8 questions that ask patients to rate their perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questions pertain to the previous 7 days. Five response options are used ranging in value from 1 (not to all) to 5 (very much). The total raw score is calculated by the sum of values of the response to each question (min 8, max 40).
Timepoint [9] 335632 0
6 and 12 months from enrollment.
Secondary outcome [10] 335633 0
Fatigue will be measured using the PROMIS™ Short Form 8a (patient self-report). The tool consists of 8 questions that ask patients to rate their perceptions of fatigue symptoms ranging from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities over a 7 day period. Five response options are used ranging in value from 1 (not to all) to 5 (very much). The total raw score is calculated by the sum of values of the response to each question (min 8, max 40).
Timepoint [10] 335633 0
6 and 12 months from enrollment
Secondary outcome [11] 335634 0
Change in patient’s global rating of overall change in their knee OA. Patients will be asked to rate their overall perceived change in OA on a 7-point scale ranging from “much worse” to “much better”.
Timepoint [11] 335634 0
6 and 12 months from enrollment.
Secondary outcome [12] 335635 0
Satisfaction with treatment will be measured on a 7-point scale ranging from “extremely unsatisfied” to “extremely satisfied”.
Timepoint [12] 335635 0
6 and 12 months from enrollment.
Secondary outcome [13] 335636 0
Satisfaction with change in knee OA symptoms (outcome) will be measured on a 7-point scale ranging from “extremely unsatisfied” to “extremely satisfied”.
Timepoint [13] 335636 0
6 and 12 months from enrollment.
Secondary outcome [14] 335637 0
Change in lost productivity will be measured using the Work Productivity and Activity Impairment Questionnaire: Osteoarthritis of the Knee V2.0 (WPAI:OA). This instrument measures the time away from the work because of knee OA and the effect of knee OA on productivity while at work. The questions pertain to the previous 7 days.
Timepoint [14] 335637 0
6 and 12 months from enrollment.
Secondary outcome [15] 335638 0
Health care expenditure will be extracted from Medicare Benefit Schedule (MBS) and Pharmaceutical Benefit Scheme (PBS) data. The Australian Department of Health Services collects information on medical visits and procedures, and the associated costs and PBS collects information on prescriptions medicines filled at pharmacies.
Timepoint [15] 335638 0
12 months from enrollment.
Secondary outcome [16] 335672 0
An economic evaluation of the cost-effectiveness of the intervention analysing a range of outcomes including incremental cost per extra person with a clinically significant improvement in pain (measured as 1.8 point reduction on the pain score) and function (6 unadjusted units) and per quality-adjusted life years (QALYs). QALYs will be calculated based on utility scores using the AQoL-8D and will compare the differences in health care usage and utility gains on the AQoL-8D over 12 months between intervention and control groups. We will also compare improvements in productivity lost from baseline to 12 months between intervention and control groups.
Timepoint [16] 335672 0
12 months from enrollment.

Eligibility
Key inclusion criteria
We will recruit General Practices, GPs and their patients to participate in the trial. The criteria for each group is:

a) General Practices
Inclusion:
• At least one GP from the practice agree to be involved.
• The practice uses a general practice clinical desktop system compatible with the electronic medical record decision support tool (cdmNet).
• Practice has current public liability insurance.
• Practice consents to be randomised.

b) GPs
Inclusion:
• Works in a participating practice.
• Registered and has current professional indemnity insurance.
• Provides written informed consent.
• Willing to undertake the study as per protocol.
• Treats patients with knee OA.

c) Patients
Inclusion:
These inclusion criteria are based on those recommended by the National Institute for Health and Care Excellence (NICE) Guidelines for Osteoarthritis Care and Management in Adults:
• aged 45 years or older.
• had activity related knee pain for at least 3 months.
• has knee pain of 4 or greater on an 11-point numerical rating scale (NRS) at the time of screening.
• are a patient of a GP recruited to the trial or agree to see a recruited GP in the same practice
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will recruit General Practices, GPs and their patients to participate in the trial. The exclusion criteria for each group is:

a) General Practices:
• Participated in the pilot study.
• The practice principal or practice manager refuses participation.
• The practice does not have one or more GPs who treat patients with knee OA.

b) GPs
• Works at more than one of the general practices included in the trial.
• Participated in the pilot study.

c) Patients
• non-English speaker or unable to give informed consent (including patients in high level care, or with any medical condition which precludes giving informed consent (e.g. dementia, intellectual disability, mental health issues).
• non-ambulatory or limited mobility.
• has had knee replacement surgery in the affected knee or is booked for surgery. Patients may still be included if their other knee meets the inclusion criteria and it has not undergone a knee replacement.
• is terminally ill, has rheumatoid arthritis or gout, or any other severe inflammatory condition, or is undergoing active treatment for serious medical conditions which would preclude participation in this study (e.g. cancer treatment).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will be using opaque, sealed envelopes to conceal allocation. The Trial Coordinator in Sydney or their delegate will open the envelopes once all GPs in the practice have been recruited to the trial. The allocation will be communicated to the general practice via the GP Coordinator once all GPs have reviewed the patient list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will be randomising the general practices (clusters) rather than individual patients as the intervention involves changes at the GP practice level. General practices will be randomised to the Intervention or Usual Care group at a 1:1 ratio, and by random permuted blocks of sizes 8, 10 and 12. Stratification will be by practice size (<4 GPs, 4+ GPs) and location (metropolitan, regional/rural). The general practice will be randomised once all GP recruitment at the site has been completed.

Offsite computer-generated randomisation will be conducted by the Biostatistics Unit of the School of Public Health and Preventive Medicine at Monash University, Victoria, Australia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
GPs will be aware of their group allocation, however patients will be kept naive to the specific details of the two study arms.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Estimation, Power and Justification :

Primary endpoints are at the patient level and are defined as changes in knee pain and function at 12 months. We wish to detect an effect size of 0.30. Our sample size accounts for clustering effects due to people treated by the same GP. Assuming a minimum of 2 GPs per practice, 20 patients per GP practice recruited, with a coefficient of variation in practice size of 0.5, an intra-cluster correlation of 0.05 and up to 20% attrition of both GPs and patients, a total of 44 general practices and 572 patients will be required to detect the effect size with 80% power (two-sided significance level of 5%).

Statistical Methods:

GP practices and individual participants will be analysed according to their randomised group, regardless of treatment actually received. Those practices that fail to recruit any patients or withdraw from the study prior to collecting data from any patients will be excluded from the analysis. Descriptive statistics at the participant and GP practice level will be presented to allow comparison of treatment groups at baseline. Analyses will be conducted at the participant level. For continuous outcome measures, differences in mean change (baseline minus follow-up) will be compared between groups using generalised estimating equations (GEEs) to account for within-practice correlation with exchangeable correlation, robust standard errors, and adjusting for the baseline value of the outcome variable and stratification variables. For binary outcomes, GEEs will be fitted using a logit link function assuming an exchangeable correlation structure and robust variance estimation, adjusting for stratification variables, with results presented as odds ratios. To aid interpretation, risk differences will also be calculated using marginal probabilities. Multiple imputation will be applied to missing participant-level data from GP practices which do not withdraw from the study prior to data collection and who recruit at least one patient.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 296657 0
Government body
Name [1] 296657 0
National Health and Medical Research Council (NHMRC)
Address [1] 296657 0
16 Marcus Clarke St
Canberra ACT 2601
Country [1] 296657 0
Australia
Funding source category [2] 296659 0
Commercial sector/Industry
Name [2] 296659 0
Medibank Health Research Fund (Good2Give)
Address [2] 296659 0
Level 5, 100 Walker Street
North Sydney, NSW 2060
Country [2] 296659 0
Australia
Funding source category [3] 296660 0
Commercial sector/Industry
Name [3] 296660 0
nib Health Funds
Address [3] 296660 0
22 Honeysuckle Drive
Newcastle, NSW, 2300
Country [3] 296660 0
Australia
Funding source category [4] 296662 0
Commercial sector/Industry
Name [4] 296662 0
BUPA Australia
Address [4] 296662 0
33 Exhibition Street
Melbourne, VIC, 3000
Country [4] 296662 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 295614 0
University
Name [1] 295614 0
University of Melbourne
Address [1] 295614 0
Grattan Street,
Parkville, Victoria, 3010
Country [1] 295614 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297883 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 297883 0
Research Integrity & Ethics Administration
Research Portfolio
Level 2, Margaret Telfer Building (K07)
The University of Sydney
Sydney, NSW, 2006
Ethics committee country [1] 297883 0
Australia
Date submitted for ethics approval [1] 297883 0
07/11/2016
Approval date [1] 297883 0
05/04/2017
Ethics approval number [1] 297883 0
2016/959
Ethics committee name [2] 297885 0
Behavioural and Social Sciences Human Ethics Sub-Committee
Ethics committee address [2] 297885 0
Grattan Street,
Parkville, Victoria, 3010
Ethics committee country [2] 297885 0
Australia
Date submitted for ethics approval [2] 297885 0
06/04/2017
Approval date [2] 297885 0
01/05/2017
Ethics approval number [2] 297885 0
1749340
Ethics committee name [3] 297886 0
Department of Human Services External Request Evaluation Committee
Ethics committee address [3] 297886 0
Department of Human Services
(LL - South 3 Mail Point 3 or W/S LL.3.S.415)
PO Box 7788,
Canberra BC ACT 2610
Ethics committee country [3] 297886 0
Australia
Date submitted for ethics approval [3] 297886 0
06/04/2017
Approval date [3] 297886 0
04/05/2017
Ethics approval number [3] 297886 0
MI7185
Ethics committee name [4] 298672 0
UNSW HREC
Ethics committee address [4] 298672 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [4] 298672 0
Australia
Date submitted for ethics approval [4] 298672 0
03/11/2017
Approval date [4] 298672 0
09/11/2017
Ethics approval number [4] 298672 0

Summary
Brief summary
The PARTNER project aims to implement and evaluate a new model of service delivery to improve the health of people with knee osteoarthritis (OA) in Australia. Currently, the day-to-day care of people with OA in Australia is inconsistent with care recommended in established clinical guidelines. Our new model focuses on both the person with OA and their general practitioner (GP). Firstly, the intervention will support GPs to gain an understanding of the effective conservative, non-surgical management options available for treatment of patients with OA. GPs will be provided with professional development and training including audit/feedback, and electronic medical record decision support. Secondly, patients will receive advice and support on issues related to the management of OA including exercise, weight loss, pain management and other self-management behaviours. The intervention will be delivered remotely by a centralised, multidisciplinary team of health professionals trained in best-practice OA management. This ‘Care Support Team’ (CST) will also have skills in health coaching and behavioural change which will support patients to manage their knee OA, and will help the GP facilitate additional healthcare services if required. This project will implement and evaluate the proposed model of service delivery (PARTNER model) in a mixed methods study including a randomised controlled trial (RCT) in two Australian states with economic and qualitative evaluations. This trial will help us to better understand the effectiveness, feasibility, acceptability, sustainability and cost-effectiveness of the model. We are partnering with a range of academic, industry and professional health organisations to ensure optimal delivery of the model and to facilitate long-term implementation into the Australian healthcare system.
Trial website
Trial related presentations / publications
Public notes
We are recruiting 44 general practices and 572 patients. The general practices are being randomised. We are recruiting practices throughout NSW and Victoria, Australia.

Contacts
Principal investigator
Name 75358 0
Prof David Hunter
Address 75358 0
Dept of Rheumatology, The University of Sydney
7C ASB, Royal North Shore Hospital
St Leonards, NSW, 2065
Country 75358 0
Australia
Phone 75358 0
+61 2 9463 1887
Fax 75358 0
+61 2 9463 1077
Email 75358 0
david.hunter@sydney.edu.au
Contact person for public queries
Name 75359 0
Dr Jocelyn Bowden
Address 75359 0
Dept of Rheumatology, The University of Sydney
7C ASB, Royal North Shore Hospital
St Leonards, NSW, 2065
Country 75359 0
Australia
Phone 75359 0
+61 2 9463 1898
Fax 75359 0
+61 2 9463 1077
Email 75359 0
jocelyn.bowden@sydney.edu.au
Contact person for scientific queries
Name 75360 0
Dr Jocelyn Bowden
Address 75360 0
Dept of Rheumatology, The University of Sydney
7C ASB, Royal North Shore Hospital
St Leonards, NSW, 2065
Country 75360 0
Australia
Phone 75360 0
+61 2 9463 1898
Fax 75360 0
+61 2 9463 1077
Email 75360 0
jocelyn.bowden@sydney.edu.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?
Initially, individual participant data underlying published results will be available (after de-identification). Prior to this other data may be available at the discretion of the CIs.
When will data be available (start and end dates)?
Immediately following publication or as agreed by the CIs, no end date has been determined.
Available to whom?
Initially, data will be available to researchers who provide a methodologically sound proposal. Data will become available through at public database once the major findings have been published.
Available for what types of analyses?
No restrictions
How or where can data be obtained?
Initially access will be subject to approvals by Principal Investigator, and may require a data access agreement. Data will eventually be submitted to a public database.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results