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Trial registered on ANZCTR


Registration number
ACTRN12619000871145
Ethics application status
Approved
Date submitted
4/04/2019
Date registered
19/06/2019
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating an innovative means of delivering musculoskeletal primary healthcare to improve patient outcomes and reduce cost.
Scientific title
Implementation of a novel clinical PAthway of CarE to improve patient health outcomes and reduce costs for common musculoskeletal disorders in primary care (PACE study)
Secondary ID [1] 297372 0
National Health and Medical Research Council Project grant: APP1141377
Universal Trial Number (UTN)
Trial acronym
PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 311509 0
Neck pain 311510 0
Osteoarthritis of the Knee 311511 0
Whiplash 312296 0
Condition category
Condition code
Musculoskeletal 310142 310142 0 0
Other muscular and skeletal disorders
Musculoskeletal 310850 310850 0 0
Osteoarthritis
Public Health 310851 310851 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: Patients will initially undergo baseline assessment of risk for poor prognosis. The 10-item Orebro Musculoskeletal pain questionnaire will be used as the generic measure to assess risk of poor prognosis for all conditions. It was recently validated in a work environment by CI Nicholas and colleagues, who demonstrated that scores above 50 accurately identified people with musculoskeletal pain or injury at high risk of ongoing pain and disability. Validated condition-specific tools where available (e.g. STarT Back for low back pain; prognostic prediction tool for whiplash) will be used to cross reference, and ensure appropriate stratification. Our AI team are currently working on an additional prognostic screening tool for all musculoskeletal conditions that may also be used to cross validate when this study commences. Patients will then be randomized to usual care or the clinical pathway of care.
Clinical Pathway of Care. Participants randomised to the clinical pathway will receive matched care according to their projected risk of poor prognosis.
Low risk: Once a patient’s risk of recovery is identified, patients with a good prognosis (low risk) should do well with minimal care delivered by the patients' primary health care professional (general practitioner, physiotherapist, chiropractor or osteopath). Patients stratified to low risk will receive minimal intervention (at least 1 and up to 3 sessions of guideline based care advice and exercises). Patients will also be directed to the study online musculoskeletal e-hub resource (MY PAIN HUB) which will have links to existing evidence informed guideline-based resources developed by the CI and AI team. The research site research assistant will encourage patients by phone call (1 week and 4-6 weeks post randomization) to access this site for information, advice, exercise pages and to watch the videos.
Information in MY PAIN HUB has been adapted from the most recent evidence based guidelines for each condition. It is a one access portal bringing together all the resources to facilitate easy access and utilisation by primary health care professionals managing whiplash/neck pain, low back pain and or knee OA. In Australia, existing resources include the development and implementation of a website for whiplash (CI Rebbeck, CI Sterling, CI Cameron, AI Ritchie), for osteoarthritis (CI Simic, AI Bennell) and in the UK, low back pain (AI Foster). These outcomes are primarily the work arising from the two NHMRC Centres of Research Excellence participating in this project (CRE in recovery following road traffic injury and CRE in translational research in musculoskeletal pain). Each resource provides guideline-based information for first line care (such as provision of advice and simple exercises), recommendations on the appropriate use of musculoskeletal imaging, validated risk-stratification tools for clinicians, and recommendations on when referral for specialist care is required. Guideline based information for each condition is based on:
Knee OA: RACGP Guidelines for the management of knee and hip osteoarthritis; https://www.racgp.org.au/download/Documents/Guidelines/Musculoskeletal/guideline-for-the-management-of-knee-and-hip-oa-2nd-edition.pdf
Whiplash: State Insurance Regulatory Authority (SIRA) Whip Lash guidelines; https://www.sira.nsw.gov.au/resources-library/motor-accident-resources/publications/for-professionals/whiplash-resources/SIRA08104-Whiplash-Guidelines-1117-396479.pdf
Neck Pain: National Institute for Health and Care Excellence (NICE) Neck Pain guidelines; https://www.evidence.nhs.uk/search?q=NICE%20guidelines%20on%20treatment%20of%20neck%20pain
Back Pain: The Agency for Clinical Innovation (ACI) acute low back pain guidelines
https://www.aci.health.nsw.gov.au/resources/musculoskeletal/management-of-people-with-acute-low-back-pain/albp-model
www.mybackpain.org.au
E-health educational videos /webinars for primary health care professionals for each condition will be developed by the CI and AI team according to relevant expertise. The e-Health implementation process for the low risk group will be advised by AI Shaw (e-health Professor) and AI Foster who has completed similar strategies in the UK. Health professionals will be able to access these resources as required through the MY PAIN HUB.
Medium to high risk: or those with a poor prognosis, will be referred to a specialist musculoskeletal clinician within 6 weeks of entry to the study.
Specialist Musculoskeletal Clinicians will be recruited by the chief investigators prior to the study commencement. For the purposes of clarity in this study, a specialist is defined as a health care professional with expertise in the management of complex musculoskeletal conditions. Currently in each state, these specialist clinicians have been independently appointed by workers’ compensation and motor vehicle injury insurance regulators to perform peer review, consultancy and dispute resolution services for complex musculoskeletal injuries and disorders. These specialist musculoskeletal clinicians most commonly are physiotherapists, but can also include psychologists, chiropractors and medical practitioners. Specialist musculoskeletal clinicians who operate in this capacity, or have higher degree or fellowship qualifications in musculoskeletal health or who have provided similar care in previous trials will be recruited for this study. Prior to the commencement of the trial, specialist musculoskeletal clinicians at each treatment site will be trained to implement the pathway of care in a 1-2-day advanced musculoskeletal workshop conducted by the CI’s. The content of each workshop will be developed by the CI and AI team who are currently world leaders in their relative areas.
The specialist musculoskeletal clinician will undertake a detailed 1-hour long consultation comprising history taking and physical examination of physical, pain-related and psychological factors which are associated with non-recovery for each condition. These include assessment of physical impairments such as muscle strength and control (OA), cold hyperalgesia (whiplash), questionnaires to suggest psychological obstacles to recovery such as depression (LBP), posttraumatic stress (whiplash) and questionnaires on general health such as physical inactivity and sleep deprivation (LBP) co-morbidities (OA). The specialist musculoskeletal clinician will then make one of three decisions:
1. Shared care: The specialist musculoskeletal clinician liaises with the primary health care professional on best management. In Australia this is pragmatic, given in some instances, distances do not allow for the specialist to lead the care.
2. Specialist care: Up to 6 sessions of specialist- physiotherapy led conservative management addressing the assessed impairments. These comprise of evidence based interventions such as supervised exercise, and education with a psychologically informed cognitive/ behavioural approach.
3. Referred care: For example, to a psychologist when scores on screening questionnaires for psychological factors (e.g. depression or post-traumatic stress) are above threshold levels, to a medical pain specialist when pain features are above threshold (e.g. clinical indication of pain sensitivity) or to an orthopaedic surgeon when advanced Osteoarthritis is present.
Specialist musculoskeletal clinicians are given guidance during their training about when to make these decisions.
Patient and health professional questionnaires and health professional interviews will be used to assess and monitor adherence to the intervention.

Intervention code [1] 313626 0
Diagnosis / Prognosis
Intervention code [2] 313628 0
Treatment: Other
Comparator / control treatment
Participants randomised to usual care will receive care regardless of their prognostic risk. Usual care will be provided by their nominated primary health care professional who will not be informed of the risk category, but will be sent a letter informing them of their patient’s involvement in the trial. Decisions regarding the number of treatment sessions, content of management (assessment and treatment), and referral to other professionals will depend on the clinical judgment of the primary health care professional. Health professional practice prescribed will be collected from their patients at all follow up time points. No attempt to change usual care of participants will be made.
Control group
Active

Outcomes
Primary outcome [1] 319043 0
Evaluate health outcomes:
Health Related Quality of life (HRQOL): measured using the validated SF12 Questionnaire. Outcomes will be assessed by an assessor blinded to group allocation. Data will be collected by telephone interview, online, or return post, depending on the participant preference. Outcome data will be obtained from all randomised patients, in so far as this is possible, regardless of compliance with the trial protocol.
Timepoint [1] 319043 0
3, 6 and 12 (primary end point) months post intervention.
Primary outcome [2] 319044 0
Evaluate cost compared to usual care: The validated SF6D (derived from the SF12) will be used to determine cost effectiveness, measured as cost per Quality Adjusted Life Years (QALY) gained.
Patient questionnaires: secondary cost outcomes will be direct and indirect costs: Direct costs (e.g. general practitioner, physiotherapy, chiropractic and pharmaceutical, specialist and imaging services) will be calculated using rebates taken from the Medicare Benefits Schedule, worker’s compensation schemes and the Pharmaceutical Benefits Scheme. Direct healthcare cost (e.g. consumer co-payments) and non-healthcare costs (e.g. work absenteeism), which are not captured by these insurer payments, will be identified using patient cost diaries.
Timepoint [2] 319044 0
3 6 and 12 (primary end point) months post intervention
Secondary outcome [1] 366787 0
Pain Self Efficacy Questionnaire,
A validated and widely used tool to assess the confidence people with pain have in performing activities while in pain. Assessment of self-efficacy was chosen as an outcome of interest because the intervention chosen aims to enhance confidence to self-manage regardless of symptoms after 3 months. Pain self-efficacy has significantly improved in other trials of musculoskeletal pain.
Timepoint [1] 366787 0
3, 6, 12 months post intervention
Secondary outcome [2] 366788 0
Professional Practice Outcomes (Health Care Professional).
Primary and specialist professional knowledge will be assessed using a questionnaire adapted from existing tools developed by CI Rebbeck, Trevena and Cameron. It will be administered to participating practitioners by several methods: online, telephone or return post.
Timepoint [2] 366788 0
3 months
Secondary outcome [3] 369631 0
Low Back pain disability will be measured with the validated Oswestry Disability Index (ODI) for low back pain,
Timepoint [3] 369631 0
3,6,12 Months
Secondary outcome [4] 369632 0
Neck pain disability will be measured with the validated Neck Disability Index (NDI) for neck pain,
Timepoint [4] 369632 0
3,6,12 months
Secondary outcome [5] 369633 0
Knee osteoarthritis disability will be measured with the validated WOMAC Osteoarthritis Index LK3.1
Timepoint [5] 369633 0
3,6,12 months
Secondary outcome [6] 369634 0
Generic health and disability will be measured with the validated World Health Organization disability assessment schedule II short form (WHODASII)
Timepoint [6] 369634 0
3,6,12 months
Secondary outcome [7] 369636 0
Professional Practice Outcomes (Patient). Professional practice outcomes (patient) will be collected with the validated Working Alliance Inventory (WAI) (Short form C).
Timepoint [7] 369636 0
3 months
Secondary outcome [8] 371436 0
Professional practice outcomes (patient)
Health professional practice prescribed will be collected from their patients with research developed questionnaires at all follow up time points.
Timepoint [8] 371436 0
3, 6, 12 months
Secondary outcome [9] 371457 0
Patient depression, anxiety and tension/stress will be measured using the validated depression anxiety stress scale (DASS-21)
Timepoint [9] 371457 0
3, 6, 12 months
Secondary outcome [10] 371458 0
Patients thoughts and feelings about their pain will be measured using the validated pain catastrophising scale (PCS)
.
Timepoint [10] 371458 0
3, 6, 12 months
Secondary outcome [11] 371506 0
Professional Practice Outcomes (Health Care Professional). Primary and specialist professional knowledge will be assessed with the validated Working Alliance Inventory (Short Form T). This will be administered to participating practitioners by several methods: online, telephone or return post
Timepoint [11] 371506 0
3 months
Secondary outcome [12] 371508 0
Primary and specialist professional knowledge will be assessed with qualitative semi-structured interviews. Qualitative semi-structured interviews will be conducted with a random sample of professional participants to investigate barriers and facilitators of changing practice in line with the stratified care pathway. All participants will receive an invitation with relevant information about the study together with follow up contact details to answer any additional questions. Once written consent is obtained Interviews will be conducted at an agreed time. All interviews will be one-to-one, conducted face-to-face or via telephone, will take 20 to 60 minutes to complete, be audio-recorded and information transcribe.

Timepoint [12] 371508 0
3 months

Eligibility
Key inclusion criteria
Low back pain, neck pain or whiplash, knee Osteoarthritis (OA): Within 4 weeks of seeking care.
Proficient in written and spoken English.
Non-specific low back or neck pain and/or grade I-III whiplash associated disorder (WAD) aged 18-65 years.
Knee OA only: 45 years of age or older, experience activity-related joint pain and have either no morning joint pain, or have joint stiffness lasting < 30 minutes. Inclusion of participants at all stages of the disease, with the exception of those who have undergone or are scheduled for joint replacement surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology (e.g. metastatic disease of the spine)
Confirmed fracture or dislocation at time of injury (WAD IV).
Extreme depression defined as at risk of self-harm (answering yes to Item 9 of the Patient Health Questionaire-9 (PHQ-9)).
Above average health according to the SF12 (>80/100 on the transformed score)
Knee OA patients excluded if they have undergone or are scheduled for joint replacement surgery.

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)
The randomisation schedule will be prepared by the NHMRC clinical trial centre randomisaiton service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by random permuted blocks of 4 to 8 stratified for risk subgroup and treatment site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A biostatistician will analyse health outcome data in a blinded manner, and a health economist the cost effectiveness analysis. All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes will be analysed independently, using cross-sectional analyses, at 3, 6, and 12 months post-intervention, using generalised linear models methods, with an appropriate link function, to test for an intervention effect adjusted for the baseline values. Effect sizes will be calculated for all measures, interpreting an effect size of 0.2 as small, 0.5 medium, and 0.8 large. Alpha will be set at 0.05. If there is a statistically significant treatment effect, we will also calculate number needed to treat (NNT) to achieve recovery of function and 95% confidence intervals.
Professional practice outcomes will be analysed using both descriptive statistics and qualitative content analysis. Median scores will be calculated for ordinal data, and frequency distribution will be reported. Codes or keywords will be identified from previous research prior to analysis of responses from the open-ended questions. Occurrences of the identified codes or keywords will be documented through frequency counts. Qualitative interviews will be assessed through thematic analysis using NVivo software.

Recruitment
Recruitment status
Not yet 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,QLD,WA,VIC
Recruitment hospital [1] 13141 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13143 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 13144 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 13145 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 13154 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 13487 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 13489 0
St John of God Hospital, Midland - Midland
Recruitment hospital [8] 13551 0
Sunshine Hospital - St Albans
Recruitment hospital [9] 13882 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 13905 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 25683 0
2050 - Camperdown
Recruitment postcode(s) [2] 25685 0
2065 - St Leonards
Recruitment postcode(s) [3] 25686 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 25687 0
4032 - Chermside
Recruitment postcode(s) [5] 25696 0
3084 - Heidelberg
Recruitment postcode(s) [6] 26106 0
6150 - Murdoch
Recruitment postcode(s) [7] 26108 0
6056 - Midland
Recruitment postcode(s) [8] 26174 0
3021 - St Albans
Recruitment postcode(s) [9] 26654 0
4215 - Southport
Recruitment postcode(s) [10] 26678 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 301939 0
Government body
Name [1] 301939 0
National health and Medical Research Council
Address [1] 301939 0
Research Committee Secretariat NHMRC
GPO Box 1421 Canberra ACT 2601
Country [1] 301939 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Cumberland Campus
75 East St. Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 301696 0
University
Name [1] 301696 0
Curtin University
Address [1] 301696 0
Kent Street
Bentley
WA 6102
Country [1] 301696 0
Australia
Secondary sponsor category [2] 302291 0
University
Name [2] 302291 0
The University of Queensland
Address [2] 302291 0
RECOVER Injury Research Centre
288 Herston Rd
Brisbane City
QLD 4029
Country [2] 302291 0
Australia
Secondary sponsor category [3] 302292 0
University
Name [3] 302292 0
The University of Melbourne
Address [3] 302292 0
Grattan Street
Parkville
Vic, 3010
Country [3] 302292 0
Australia
Other collaborator category [1] 280540 0
Individual
Name [1] 280540 0
Dr Milena Simic
Address [1] 280540 0
The University of Sydney
Cumberland Campus
75 East Street
Lidcombe
NSW 2141
Country [1] 280540 0
Australia
Other collaborator category [2] 280543 0
Individual
Name [2] 280543 0
Dr Darren Beales
Address [2] 280543 0
Curtin University
Kent Street
Bentley
WA 6102
Country [2] 280543 0
Australia
Other collaborator category [3] 280545 0
Individual
Name [3] 280545 0
Associate Professor Paulo Ferreira
Address [3] 280545 0
The University of Sydney
Camperdown
NSW 2006
Country [3] 280545 0
Australia
Other collaborator category [4] 280546 0
Individual
Name [4] 280546 0
Professor Ian Cameron
Address [4] 280546 0
Sydney Medical School Northern,
Faculty of Medicine
University of Sydney
Camperdown
NSW 2006
Country [4] 280546 0
Australia
Other collaborator category [5] 280547 0
Individual
Name [5] 280547 0
Professor Michele Sterling
Address [5] 280547 0
Faculty of Health and Behavioural Sciences,
The University of Queensland
Level 7, UQ Oral Health Centre,
288 Herston Road, Herston
QLD 4006
Country [5] 280547 0
Australia
Other collaborator category [6] 280548 0
Individual
Name [6] 280548 0
Professor Michael Nicholas
Address [6] 280548 0
Pain Management Research Institute, Northern Clinical School
Kolling Institute of Medical Research
Royal North Shore Hospital,
Pacific Hwy, St Leonards
NSW 2065, Australia

Country [6] 280548 0
Australia
Other collaborator category [7] 280549 0
Individual
Name [7] 280549 0
Professor Lyndal Trevena
Address [7] 280549 0
School of Public Health
University of Sydney
Camperdown
NSW 2006
Country [7] 280549 0
Australia
Other collaborator category [8] 280550 0
Individual
Name [8] 280550 0
Professor Luke Connolly
Address [8] 280550 0
Centre for the Business and Economics of Health
Faculty of Business, Economics and Law
University of Queensland
St Lucia,
Queensland 4072
Country [8] 280550 0
Australia
Other collaborator category [9] 280551 0
Individual
Name [9] 280551 0
Professor Kathryn Refshauge
Address [9] 280551 0
Faculty of Health Sciences
The University of Sydney.
NSW 2006
Country [9] 280551 0
Australia
Other collaborator category [10] 280552 0
Individual
Name [10] 280552 0
Dr Kerrie Evans
Address [10] 280552 0
Faculty of Health Sciences
The University of Sydney.
NSW 2006
Country [10] 280552 0
Australia
Other collaborator category [11] 280553 0
Individual
Name [11] 280553 0
Professor Kim Bennell
Address [11] 280553 0
The University of Melbourne
Grattan Street
Parkville
Victoria 3010
Country [11] 280553 0
Australia
Other collaborator category [12] 280727 0
Individual
Name [12] 280727 0
Sarah Schwartz
Address [12] 280727 0
The University of Melbourne
Centre for Health, Exercise and Sports Medicine | Department of Physiotherapy
Level 7, Alan Gilbert Building
161 Barry Street
Parkville
Victoria 3010

Country [12] 280727 0
Australia
Other collaborator category [13] 280728 0
Individual
Name [13] 280728 0
Sarah Robins
Address [13] 280728 0
RECOVER Injury Research Centre
288 Herston Rd
Brisbane City
QLD 4029
Country [13] 280728 0
Australia
Other collaborator category [14] 280729 0
Individual
Name [14] 280729 0
Eileen Boyle
Address [14] 280729 0
Curtin University
Kent Street
Bentley
WA 6102
Country [14] 280729 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302621 0
University of Sydney, Human research and Research Integrity and Ethics
Ethics committee address [1] 302621 0
Level 3, Jane Foss Russell Building (G02),
Darlington Campus
NSW 2008
Ethics committee country [1] 302621 0
Australia
Date submitted for ethics approval [1] 302621 0
05/12/2018
Approval date [1] 302621 0
21/03/2019
Ethics approval number [1] 302621 0
2018/926

Summary
Brief summary
Musculoskeletal conditions, low back pain, neck pain/whiplash and osteoarthritis of the knee are one of the highest contributors to years lost to disease. The PACE intervention aims to identify patients at risk of poor prognosis to improve their management in primary health care settings. Patients identified as low risk will receive minimal intervention (up to 3 sessions of guideline based care advice and exercises). Those identified as medium to high risk will be referred to a specialist musculoskeletal clinician who will undertake a more complex examination of individual physical, psychological and pain factors. The specialist clinician will then liaise with the patient and the primary health care practitioner to decide further care. We hypothesize that implementation of this novel musculoskeletal clinical care pathway will result in improved health outcomes and be more cost-effective. If successful PACE will be a useful addition to primary care musculoskeletal care management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90850 0
Dr Trudy Rebbeck
Address 90850 0
The University of Sydney
Faculty of Health Sciences, Discipline of Physiotherapy:
John Walsh Centre for Rehabilitation Research, Kolling Institute, Royal North Shore Hospital
75 East Street Lidcombe
The University of Sydney
NSW 2141
Country 90850 0
Australia
Phone 90850 0
+61411100600
Fax 90850 0
Email 90850 0
trudy.rebbeck@sydney.edu.au
Contact person for public queries
Name 90851 0
Dr Trudy Rebbeck
Address 90851 0
The University of Sydney
Faculty of Health Sciences, Discipline of Physiotherapy:
John Walsh Centre for Rehabilitation Research, Kolling Institute, Royal North Shore Hospital:
75 East Street Lidcombe
The University of Sydney
NSW | 2141
Country 90851 0
Australia
Phone 90851 0
+61411100600
Fax 90851 0
Email 90851 0
trudy.rebbeck@sydney.edu.au
Contact person for scientific queries
Name 90852 0
Dr Trudy Rebbeck
Address 90852 0
The University of Sydney
Faculty of Health Sciences, Discipline of Physiotherapy:
John Walsh Centre for Rehabilitation Research, Kolling Institute, Royal North Shore Hospital:
75 East Street Lidcombe
The University of Sydney
NSW | 2141
Country 90852 0
Australia
Phone 90852 0
+61411100600
Fax 90852 0
Email 90852 0
trudy.rebbeck@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study will aggregate data prior to report and publication
What supporting documents are/will be available?
Study protocol
Ethical approval
Summary results
No Results