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Trial registered on ANZCTR


Registration number
ACTRN12619000969167
Ethics application status
Approved
Date submitted
4/06/2019
Date registered
9/07/2019
Date last updated
10/02/2023
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
LEAP-CP: Learning through Everyday Activities with Parents for Indigenous Australian infants at high risk of cerebral palsy and neurodevelopmental disabilities
Scientific title
Peer delivered early detection and intervention for infants at high risk of cerebral palsy and neurodevelopmental disabilities in Indigenous Australia
Secondary ID [1] 297339 0
Nil
Universal Trial Number (UTN)
Trial acronym
LEAP-CP-Indig
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 311454 0
Neurodevelopment disorder 313195 0
Condition category
Condition code
Neurological 310096 310096 0 0
Other neurological disorders
Musculoskeletal 311655 311655 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LEAP-CP project involves the implementation of early screening (early detection sub-study) and intervention for Aboriginal and Torres Strait Islander infants at risk of CP and/or adverse Neurodevelopmental outcomes.
The early detection sub-study will implement early detection programs for 'at risk' Aboriginal and/ or Torres Strait Islander infants born in Queensland (birth years 2020-2022). Eligible infants are those aged 0-9 months corrected age (CA) who are at risk of later adverse neurodevelopmental outcomes due to a history of any of the following factors; birth or pregnancy complications, preterm birth, low birth weight, maternal risk factors, admission to neonatal intensive care unit or special care nursery or post-neonatal complications (infection, head injury, stroke).
Participants will be recruited from study geographical sites prior to 9 months CA and will be screened at two time points, (i) birth to 5 months CA (2x5 minute observational videos which can be taken at home on a mobile phone), and (ii) 4 to 9 months CA (1 hour visit with a health professional for neurological and developmental assessment). Medical information collected is consistent with the intervention study (as described in the outcomes). Infants can enter the study at any time between birth and 9 months CA, and will commence the relevant screening protocol based on their age at study entry. Outcome measures will be completed at 12 months. Eligible infants (based on early screening results) will commence the LEAP-CP intervention.
The LEAP -CP intervention is a multidisciplinary family-centred intervention delivered peer to peer in the home during 30 weekly 2-hour visits (over a 7-10 month period, allowing for missed visits due to illness and family/ ceremonies). During the visit, the Indigenous Allied Health Worker (peer trainer) will (1) gather feedback and troubleshoots the previous visit's activities, (2) deliver the therapeutic modules includes motivating infant-generated activities practiced to optimise learning; using principles of structure, repetition, and variation. Functional motor skills, such as reach/grasp and attaining anti-gravity postures. (3) deliver the educational module. The caregiver will be provided with written and pictographic information of the program specific to this study, to facilitate their use of the strategies each day during the upcoming week.
The education is discussion on topics based with question prompts for the community worker following 'the 5As' - ask (find out what the parent is currently doing through questions and observation), affirm (affirm their parenting strengths and wisdom), add (build on what they are doing), answers to problem (support the parent to problem silver barriers to implementing change) and action (support the parent to identify action for the coming week).

The Indigenous Allied Health Worker will receive a 3-day training package at the onset of the programme. This will include topics such as:
* Building rapport and positive therapeutic relationship with caregivers
* Exploring customs, beliefs and family culture
* Using everyday opportunities and routines to encourage infant development
* Observation skills and coaching
* Motor training and therapeutic principles
* Understanding typical development and development in children with cerebral palsy
* Ethics and research practices

Monitoring of the sessions will be conducted by the regional team leader, and they will collaborate with a centralised allied health coordinator on the program content on a monthly schedule utilising online telehealth facilities.
Intervention code [1] 313589 0
Rehabilitation
Intervention code [2] 314697 0
Treatment: Other
Comparator / control treatment
Care as usual consists of the routine primary and allied health programs provided in the community, in addition to specific post-natal health advice programs (eg first 1000 days programs). Care as usual will be documented on the health resource use form. If there are no routine post-natal programs delivered in the community, a basic health advice program will be delivered once per month (7 visits) by a community health worker, based on the World Health Organisation’s Integrated Management of Childhood Illness Key Family Practices. This includes counselling on breastfeeding and introduction of complementary nutrition, hygiene practices, vaccination counselling, and management of the sick child.
Control group
Active

Outcomes
Primary outcome [1] 318988 0
Peabody Developmental Motor Scales, 2nd Edition (PDMS-2)

The child’s motor outcomes will be assessed using the Peabody Developmental Motor Scales – 2nd edition (PDMS-2), a commonly used measure of motor skills in infants and children aged birth to 6 years. It has demonstrated validity and responsiveness in infants with CP.
Timepoint [1] 318988 0
Baseline, 12 months CA, immediately post-intervention, final outcome (24 months CA).
Primary outcome [2] 318989 0
Bayley Scales of Infant Development-III
Timepoint [2] 318989 0
Baseline, post-intervention and final outcome (24 months CA)
Primary outcome [3] 318990 0
Depression, Anxiety and Stress Scale

The Depression, Anxiety, Stress Scale – Short Form (DASS) is a 21 item self-report questionnaire reflecting the frequency or severity of the caregiver’s experiences with depression, anxiety and stress over the past week. It has high internal consistency (a=0.83, 0.78 and 0.87 for depression, anxiety and stress respectively (Norton, 2007). High convergent validity has been established between the DASS and other measures of similar constructs: DASS depression scale and the Beck Depression Inventory (r= 76), DASS anxiety scale and the Beck Anxiety Scale (r= .74) and DASS stress scale and the Positive and Negative Affect Schedule (r= .74).
Timepoint [3] 318990 0
Final outcome is at 24 months corrected age.
Secondary outcome [1] 366655 0
Canadian Occupational Performance Measure (COPM)
Timepoint [1] 366655 0
Baseline, 3 monthly during intervention duration, post-intervention
Secondary outcome [2] 366656 0
Pediatric Evaluation of Disability Inventory -- Computer Adaptive Test (PEDI-CAT)

The child’s functional outcomes in self-care, mobility and social function will be assessed using parent-report on the PEDI-CAT. The PEDI-CAT has been Rasch-analysed in children with disabilities and typical development. Raw scores will be converted to standardised scores (0-100).
Timepoint [2] 366656 0
Baseline, 12 months CA, post intervention (7-10 months post intervention commencement)
Secondary outcome [3] 366657 0
Nutritional status (length/ height, weight, mid upper arm circumference)

Nutritional status will be determined using length/ height and weight which will be converted to z scores using the World Health Organization age and gender referenced data.
Weight will be measured using scales, length, and arm circumferences will be measured using tape measure.
Timepoint [3] 366657 0
Baseline, post-intervention, final outcome (24 months CA)
Secondary outcome [4] 366658 0
Changed to Preverbal Visual Assessment: a caregiver reported evaluation of visual cognitive integrative functions through behavioural assessment for children aged <2 years.
Timepoint [4] 366658 0
Baseline, post-intervention, final outcome (24 months corrected age)
Secondary outcome [5] 366659 0
Emotional Availability Scale (EAS)

The Emotional Availability Scale (EAS)26 27 is a 20-minute observation of the parent-infant relationship. The parent-infant observation will be a naturalistic observation of a parent-infant interaction in the family’s own home. The IAHW will assist parents to record the interaction, using a recording device of their own or supported by the community worker. The EAS measures the quality of the relationship itself across six scales: parental sensitivity, parental structuring, parental non-intrusiveness, parental non-hostility, child responsiveness and child involvement. The scale has high inter-rater reliability for parental responsiveness (.96), involving (.87), sensitivity (.93) and structuring.
Timepoint [5] 366659 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [6] 366660 0
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Timepoint [6] 366660 0
At 12 months the ITSEA will still be used, to provide additional information for differential diagnosis. The BITSEA will be administered at post-intervention (immediately following intervention) and final outcome (24 months CA)
Secondary outcome [7] 366661 0
Infant Toddler Quality of Life Questionnaire (IT-QOL)

The ITQOL was developed for use in infants and toddlers 2 months - 5 years. The ITQOL short form measures quality of life across physical, mental and social well-being. The test has 47 items in the short-form and is completed by parent-report. For each of the 47 concepts, item responses are scored, summed, and transformed to a scale from 0 (worst health) to 100 (best health).
Timepoint [7] 366661 0
Final outcome only (24 months CA)
Secondary outcome [8] 367775 0
Home Observation for Measurement of the Environment (HOME) Inventory: Infant and Toddler Version

Home Observation for Measurement of the Environment (HOME) Inventory: Infant and Toddler Version is a measure of the quality and quantity of parent and home stimulation, covering six domains of parent responsiveness, acceptance, and involvement; and the home physical environment including availability of learning materials, and variety of stimulation.
Timepoint [8] 367775 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [9] 412297 0
Differential diagnosis of neurodevelopment disorders: Infants will complete diagnostic specific outcome measures (i) Autism Observation Scale for Infants (AOSI; Autism Spectrum Disorder) and (ii) clinical assessment of physical features of Fetal Alcohol Spectrum Disorder to determine the presence of symptomology and risk of a later diagnosis of ASD and/or FASD. Functional severity, motor type and distribution of CP will be ascertained for infants who have a confirmed or high-risk diagnosis of CP.
Timepoint [9] 412297 0
12 months corrected age for all infants recruited to the early detection sub-study
Secondary outcome [10] 418428 0
Australian Therapy Outcome Measure for Indigenous Clients (ATOMIC) is a culturally responsive goal-setting tool for interdisciplinary practice.
Timepoint [10] 418428 0
Baseline, iteratively throughout intervention (as indicated by caregiver identifying a new goal), immediately post-intervention.
Secondary outcome [11] 418429 0
Ages and Stages Questionnaire-TRAK (ASQ-TRAK) is the only developmental assessment adapted and validated specifically in the target population (adaptation of the ASQ-3).
Timepoint [11] 418429 0
12 months CA and final outcome (24 months CA)
Secondary outcome [12] 418430 0
Emotional Availability Self Report (EA-SR) is a parent-reported tool for evaluating the emotional availability of the caregiver-infant relationship.
Timepoint [12] 418430 0
Baseline, immediately post-intervention and final outcome (24 months CA)
Secondary outcome [13] 418431 0
Hammersmith Infant Neurological Examination is a screening tool for neurological status.
Timepoint [13] 418431 0
Screening, baseline, immediately post-intervention and final outcome (24 months CA).
Secondary outcome [14] 418432 0
Gross Motor Function Measure-66
Timepoint [14] 418432 0
Baseline and final outcome (24 months CA)

Eligibility
Key inclusion criteria
Infants aged 0-9 months CA (early detection sub-study) and 3 to 12 months +2 weeks CA (intervention study), residing in a study geographical area, with one or both parents identifying as Aboriginal or Torres Strait Islander, who are at risk of later adverse neurodevelopmental outcomes due to a history of any of the following factors; birth or pregnancy complications, preterm birth, low birth weight, maternal risk factors, admission to neonatal intensive care unit or special care nursery or post-neonatal complications (infection, head injury, stroke) will be recruited to this study.

Infants will be screened and must be assessed as ‘high risk of CP/ NDD’ or have a confirmed diagnosis of CP (confirmed by paediatrician).
Infants are determined to be high risk of CP/ NDD if assessed as:
(i) ‘Absent’ or ‘abnormal’ fidgety on General Movements Assessment for infants aged 12-17 weeks; OR GMA ‘fidgety’ with segmental asymmetries; AND
(ii) ‘Suboptimal score’ (score<57 at 3m, <60 at 6m, <63 at 9m, <67 at 12m) on the Hammersmith Infant Neurological Examination (90% predictive of CP) if aged >18 weeks; OR ‘normal’ HINE score with 5 or more asymmetries (with confirmation from Hand Assessment in Infants with a 3 point difference between limbs).18 If infants enter the study after 18 weeks CA (ie no GMs assessment), eligibility will be achieved by a score indicating risk on the HINE/ 5 or more asymmetries PLUS a clinical history congruent with a diagnosis of CP; OR
(iii) ‘Abnormal’ neuroimaging results associated with a motor disability including an abnormality in one or more of the following structures: sensorimotor cortex, basal ganglia, posterior limb of the internal capsule AND (i) OR (ii).

The Rapid Neurodevelopmental Assessment (4-9 months CA), Ages and Stages Questionnaire - Aboriginal adaptation (4-9 months CA) and General movements assessment motor optimality score (3-5 months CA) will also be conducted for participants in the early detection sub-study to use in concurrent and predictive validity data for other disabilities.
Infants will be screened for eligibility for study inclusion until target of n=86 is reached
Minimum age
3 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with complex medical conditions requiring acute medical care will be excluded

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)
Group allocation will be assigned following baseline assessment by an independent researcher, as generated from a central database (RedCAP) using a concealed random number sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (group n=6, randomly allocated in 1:1 ratio), stratified by neurological severity HINE (<40/40+) based on computer generated sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intervention study:
Between group differences for the dual primary infant outcome measures (PDMS-2 raw score and BSID-III raw score; continuous data) and caregiver primary outcome measure (DASS) will be compared using linear regression analyses. The between-group differences at baseline for key characteristics (age, gender, epilepsy, GMFCS, motor type, preterm status) will be calculated, and if any characteristics differs at p<0.01 it will be included as a covariable in all regression models. Secondary analyses will consider gains on function (PEDI-CAT), nutritional status, vision, goal attainment, social-emotional development, emotional availability, caregiver outcomes, and analysed similiarly. Analyses will be conducted on an intention to treat basis. No imputation of missing data will occur. Statistical significance will be set at p<0.05. A/Prof Mark Chatfield (Biostatistics) will provide expert advice on the analysis.
Detection sub-study:
Predictor and outcome variables will be identified as continuous, categorical or binary. Analysis will explore means, variability and distributions of continuous variables and the rate of occurrence and distribution of binary variables. Logistic regression analysis (binary outcomes), linear regression (continuous outcomes) and multinomial logistic regression (categorical outcomes) will be used to determine any associations between predictor and outcome variables. Diagnostic statistics, including sensitivity, specificity, positive and negative predictive values and accuracy of the predictive assessments (GMA, MOS, HINE, RNDA and ASQ-TRAK) will be determined with 95% confidence intervals based on an outcome of ‘at risk’ of specific NDD, (i) CP, (ii) ASD, (iii) FASD and/or (iv) adverse NDO (non-specific) at 12 months CA. Perinatal variables, social and environmental data, caregiver mental health outcomes (DASS-21) and clinical neuroimaging will be utilised as descriptive measures and covariates in regression models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
1/07/2021
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
86
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13810 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 13811 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 13812 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 13813 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [5] 13814 0
Mount Isa Base Hospital - Mount Isa
Recruitment postcode(s) [1] 26563 0
4101 - South Brisbane
Recruitment postcode(s) [2] 26566 0
4700 - Rockhampton
Recruitment postcode(s) [3] 26565 0
4814 - Douglas
Recruitment postcode(s) [4] 26567 0
4825 - Mount Isa
Recruitment postcode(s) [5] 26564 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 301902 0
Charities/Societies/Foundations
Name [1] 301902 0
Children's Hospital Foundation
Country [1] 301902 0
Australia
Funding source category [2] 301910 0
Charities/Societies/Foundations
Name [2] 301910 0
Cerebral Palsy Alliance
Country [2] 301910 0
Australia
Funding source category [3] 301911 0
Government body
Name [3] 301911 0
National Health and Medical Research Council
Country [3] 301911 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 301664 0
None
Name [1] 301664 0
None
Address [1] 301664 0
NA
Country [1] 301664 0
Other collaborator category [1] 280532 0
Other
Name [1] 280532 0
Apunipima Cape York Health Council
Address [1] 280532 0
186 Mccoombe St,
Bungalow QLD 4870
Country [1] 280532 0
Australia
Other collaborator category [2] 280533 0
Hospital
Name [2] 280533 0
Cairns and Hinterland Hospital and Health Services
Address [2] 280533 0
165 The Esplanade,
Cairns Qld 4870
Country [2] 280533 0
Australia
Other collaborator category [3] 280534 0
Hospital
Name [3] 280534 0
Townsville Hospital and Health Service
Address [3] 280534 0
100 Angus Smith Dr,
Douglas QLD 4814
Country [3] 280534 0
Australia
Other collaborator category [4] 280535 0
Hospital
Name [4] 280535 0
Rockhampton Base Hospital
Address [4] 280535 0
Canning St,
Rockhampton City QLD 4700
Country [4] 280535 0
Australia
Other collaborator category [5] 282373 0
Other
Name [5] 282373 0
Gurriny Yealamucka Health Service
Address [5] 282373 0
1 Bukki Road,
Yarrabah, QLD 4871
Country [5] 282373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302592 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [1] 302592 0
Level 7, William McCormack Place 2,
5B Sheridan Street
Cairns QLD 4870
Ethics committee country [1] 302592 0
Australia
Date submitted for ethics approval [1] 302592 0
26/06/2019
Approval date [1] 302592 0
27/09/2019
Ethics approval number [1] 302592 0
HREC/2019/QCH/50533
Ethics committee name [2] 311358 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [2] 311358 0
Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [2] 311358 0
Australia
Date submitted for ethics approval [2] 311358 0
20/04/2020
Approval date [2] 311358 0
10/09/2020
Ethics approval number [2] 311358 0
HREC/20/QCHQ/63906
Ethics committee name [3] 311359 0
Human Research Ethics Committee Townsville Hospital and health Service
Ethics committee address [3] 311359 0
The Townsville Hospital
100 Angus Smoth Drive, Douglas, QLD 4814
Ethics committee country [3] 311359 0
Australia
Date submitted for ethics approval [3] 311359 0
11/10/2019
Approval date [3] 311359 0
14/09/2020
Ethics approval number [3] 311359 0
HREC/QTHS/56008
Ethics committee name [4] 311360 0
Human Ethics Research Office the University of Queensland
Ethics committee address [4] 311360 0
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [4] 311360 0
Australia
Date submitted for ethics approval [4] 311360 0
Approval date [4] 311360 0
20/03/2020
Ethics approval number [4] 311360 0
2020000185/HREC/2019/QCH/50533

Summary
Brief summary
Cerebral palsy (CP) is the most common childhood physical disability, and among the most costly health conditions in Australia. Consistent with the prevailing trend for poorer health outcomes for Indigenous Australians, significantly more children from Indigenous communities have CP, usually with poorer functional skills. The current state of evidence allows reliable prediction of infants at risk of CP from 13 weeks, however children in remote Indigenous communities typically don’t seek diagnosis until far later, and also face significant barriers to accessing support and intervention. This means we are missing a significant window of opportunity for treatment when infants’ neuroplasticity is optimal.

This study aims to determine the effectiveness of an early intervention program for Indigenous infants at high risk of CP. This is a randomised single blind controlled trial of 86 high risk infants (inclusion criteria: absent fidgety General Movements at 12-18 weeks, or abnormal score on the Hammersmith Infant Neurological Evaluation at 18 weeks-2 years). Infants are randomised into a community-based parent-delivered 'best practice' intervention (30 weeks of enriched environment (based on the Learning Games curriculum, demonstrated effective in over 16 RCTs); goal-directed training; and parent education, including nutrition, parenting and health) versus standard care (based on the Integrated Management of Childhood Illness). The intervention will be conducted through an Indigenous Allied Health Worker model, based on the highly effective lay health worker model, to ensure long-term sustainability. Primary infant outcomes will be measured post intervention and at 2 years corrected age using the Peabody Developmental Motor Scales and Bailey Scales of Infant Development; and primary caregiver outcomes on the Depression Anxiety and Stress Scale. It is hypothesised that children receiving the intervention will have improved motor and cognitive outcomes, and caregivers to have improved mental health. This program presents a feasible, transposable and scalable model which, if shown to be effective, has the potential to reduce the burden of disability in remote Indigenous communities of Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90750 0
Dr Katherine Benfer
Address 90750 0
Centre for Child Health Research
62 Graham St
South Brisbane QLD 4101
Country 90750 0
Australia
Phone 90750 0
+61 7 30697372
Fax 90750 0
Email 90750 0
k.benfer@uq.edu.au
Contact person for public queries
Name 90751 0
Dr Katherine Benfer
Address 90751 0
Centre for Child Health Research
62 Graham St
South Brisbane QLD 4101
Country 90751 0
Australia
Phone 90751 0
+61 7 30697372
Fax 90751 0
Email 90751 0
k.benfer@uq.edu.au
Contact person for scientific queries
Name 90752 0
Dr Katherine Benfer
Address 90752 0
Centre for Child Health Research
62 Graham St
South Brisbane QLD 4101
Country 90752 0
Australia
Phone 90752 0
+61 7 30697372
Fax 90752 0
Email 90752 0
k.benfer@uq.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?
De-identified individual data that underlie the results reported in published articles.
When will data be available (start and end dates)?
Data available from 6-36 months following article publication.
Available to whom?
These data will be made available for researchers with a methodologically sound proposal.
Available for what types of analyses?
Individual participant data meta-analysis.
How or where can data be obtained?
The proposal should be emailed to the corresponding author for consideration.
Roslyn Boyd (r.boyd@uq.edu.au), Iona Novak (INovak@cerebralpalsy.org.au), Cathy Morgan (cmorgan@cerebralpalsy.org.au), Koa Whittingham (koawhittingham@uq.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2149Study protocol    376923-(Uploaded-22-05-2019-14-42-56)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly detection of Australian Aboriginal and Torres Strait Islander infants at high risk of adverse neurodevelopmental outcomes at 12 months corrected age: LEAP-CP prospective cohort study protocol.2022https://dx.doi.org/10.1136/bmjopen-2021-053646
EmbaseStudy protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study.2023https://dx.doi.org/10.1136/bmjopen-2021-059531
N.B. These documents automatically identified may not have been verified by the study sponsor.