Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia (MovetheHip)

MovetheHip-trial: The Effectiveness of Exercise and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia

This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.

Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.

Study Overview

• Status: Recruiting
• Conditions: Hip Dysplasia
• Intervention / Treatment: Other: Exercise and patient education; Other: Usual Care

Detailed Description

This study is a parallel-group superiority randomised controlled trial. Alongside this, a health-economic study and a process-evaluation study will be conducted. Participating patients will be allocated to either exercise and patient education or usual care at a 1:1 ratio. The primary outcome is change in self-reported pain measured with Copenhagen Hip and Groin Outcome Score (HAGOS) from baseline to 6-month follow-up.

The effectiveness of exercise and patient education compared with usual care will be reported in the primary trial paper, including the primary outcome and the following secondary outcomes: HAGOS symptoms, HAGOS function in daily living (ADL), HAGOS function in sport and recreation (sport/recreation), HAGOS participation in physical activity (participation), HAGOS quality of life (QOL), the impact of hip disease with the Short Version of the International Hip Outcome Tool (iHOT-12), lower limb reach length (anterior, posteromedial, posterolateral), single-leg hip for distance (SLHD) test and hip muscle strength (flexion, extension and abduction).

The primary aim of this effectiveness trial is to investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.

The primary hypothesis: Patients randomised to exercise and patient education will have a between-group mean change score on the HAGOS pain that is at least 10 points higher than those randomised to usual care over a 6-month follow-up period.

The secondary aims are to compare mean changes between the two groups on the other HAGOS subscales over a 6-month follow-up period. Similar comparisons will be made on self-reported mean changes in the Short Version of the International Hip Outcome Tool (iHOT-12) and mean changes in performance, balance and hip muscle strength.

A full trial protocol will be published and made publicly available. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Between-group differences from baseline to 3-month and 6-month follow-up of continuous outcomes will be estimated using repeated measurement analysis in a mixed-effects model, including patient as a random effect, with a fixed factor for group and time and the corresponding interaction (Group × Time), adjusted for baseline values. Between-group differences of continuous outcomes from baseline to 6-month follow-up will be analysed with an unpaired t-test, where between-group differences of categorical data from baseline to 6-month follow-up will be analysed with a binominal regression model using risk difference as a measure of association. In this paper, all collected outcomes will be listed, and it will be described that the below listed will be reported in other papers (i.e. health-economic study and process-evaluation study) and secondary papers.

In the health-economic study, the investigators will investigate the cost-utility and cost-effectiveness of exercise and patient education compared with usual care over 12 months. Outcomes for this paper will be measured at baseline, 3-, 6-, 9- and 12-month follow-up. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years and HAGOS pain). The uncertainty around the ICER and 95% confidence intervals (CIs) surrounding the cost differences will be estimated with 95% bootstrapped CIs based on non-parametric bootstrapping and will be graphically presented on cost-effectiveness planes and cost-effectiveness acceptability curves.

In the process-evaluation study, the investigators will explore the functioning of the intervention by evaluating the implementation, mechanisms of change and the contribution of contextual factors over 6 months.

Implementation includes the implementation process, fidelity, dose and reach. The implementation process will evaluate the structures and resources through which delivery is achieved. Fidelity aspects will evaluate the extent to deliver each component as planned and registered during the intervention period using self-report questionnaires. The dose will evaluate how much intervention is delivered and registered during the intervention period using routine monitoring forms, and reach will be evaluated as patterns in uptake and adherence by baseline patient characteristics registered before and during the intervention period. Mechanisms of change include interactions between the intervention, the intervention providers and the patients. Interactions will be evaluated through four semi-structured focus group interviews with the intervention providers and the expert team (study coordinator, Kristian Thorborg and Julie S. Jacobsen) and quantitative data on reasons for not receiving surgery. Contextual factors will include events, personal understandings and interactions and their possible influence on the implementation. Contextual factors will be evaluated through one-to-one semi-structured interviews during and after the intervention period with 15-20 patients in the intervention group. Findings from quantitative and quantitative analyses will be merged, interpreted and reported jointly.

The below listed will be reported in secondary papers with a clear reference to the primary trial paper and trial registration, and it will hold "secondary analyses from a randomised controlled trial" in the title.

By using subgroup stratification, we will explore if muscle-tendon pain and pain sensitisation modify between-group changes of the primary and secondary outcomes over 6 months. Furthermore, we plan to conduct an instrumental variable analysis on primary and secondary outcomes in an attempt to investigate the efficacy of the intervention. These analyses will be reported in secondary papers with clear reference to the primary trial paper.

In addition, the investigators plan to evaluate the psychometric properties of HAGOS and iHOT-12 in patients with hip dysplasia, and finally, the investigators plan to describe if hip osteoarthritis progresses over 5 and 10 years using the Tönnis osteoarthritis classification.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie S Jacobsen, PhD; Phone Number: +4551866165; Email: jsaj@via.dk
• Study Contact Backup: Name: Inger Mechlenburg, DMSc; Phone Number: +4521679062; Email: inger.mechlenburg@clin.au.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Julie S Jacobsen, PhD; Phone Number: 51866165; Email: jsaj@via.dk
    • Contact: Inger Mechlenburg, PhD; Phone Number: 21679062; Email: inger.mechlenburg@clin.au.dk
    • Principal Investigator: Julie S Jacobsen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle >10 degrees
• Hip and/or groin pain as primary pain for at least three months
• Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
• Not candidate for PAO (negative impingement test, BMI >25, hip osteoarthritis, age >45 years or reduced hip range of motion)

Exclusion Criteria:

• Self-reported pain score >80 points measured with Copenhagen Hip and Groin outcome score
• Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
• BMI >35
• Acetabular retroversion defined by crossover sign and posterior wall sign
• Calvé Legg Perthes or epiphysiolysis
• Previous pelvic/hip surgery in index limb
• Previous pelvic/hip surgery within the last 2 years in contralateral limb
• Previous surgery due to herniated disc or spondylodesis
• Previous arthroplastic surgery in the hip, knee or ankle
• Physical (pregnancy/trauma), neurological, medical or rheumatic conditions severely affecting the hip function
• Inadequacy in written and spoken Danish, mental illness or other conditions affecting the ability to follow mandatory procedures for participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and patient education; 6-months	Other: Exercise and patient education; Over a period of 6-months, patients will be offered eight one-to-one supervised training sessions. In these sessions, patients will be instructed in a home-based exercise programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty, allowing for individualised treatment with regard to exercise quality and perceived exertion according to the Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, a focus on exercise adherence and progression, and advice on physical activity.
Active Comparator: Usual Care; 6-months	Other: Usual Care; Patients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)	HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.	From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported symptoms measured with HAGOS (continuous data)	HAGOS symptoms sub-item measures hip and/or groin symptoms and difficulties through seven individual questions on a score from 0 to 100, higher score indicates lower symptoms.	From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)	HAGOS ADL sub-item measures degree of difficulty due to hip and/or groin problems through five individual questions on a score from 0 to 100, higher score indicates higher function.	From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)	HAGOS sport/recreation sub-item measures degree of difficulty due to hip and/or groin problems through eight individual questions on a score from 0 to 100, higher score indicates higher function.	From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)	HAGOS participation sub-item measures how degree of ability to participate in physical activities is affected by hip and/or groin problems through two individual questions on a score from 0 to 100, higher score indicates higher ability to participate in physical activities.	From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in self-reported quality of life (QOL) measured with HAGOS (continuous data)	HAGOS QOL sub-item measures hip-related quality of life through five individual questions on a score from 0 to 100, higher score indicates higher quality of life.	From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in impact of hip disease using the Short Version of the International Hip Outcome Tool (iHOT- 12) (continuous data)	iHOT-12 measures impact of hip disease in young, active patients through 12 questions on a score from 0-100.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up. In addition at 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Change in anterior lower limb reach distance measured with the Y-balance test (continuous data)	Anterior lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in posteromedial lower limb reach distance measured with the Y-balance test (continuous data)	Posteromedial lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in posterolateral lower limb reach distance measured with the Y-balance test (continuous data)	Posterolateral lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in single-leg jump distance measured with single-leg hop for distance test (continuous data)	Single-leg jump test measures functional performance when jumping on one leg, reported in cm normalised to height.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip flexion strength using a dynamometer with external belt-fixation (continuous data)	Isometric hip flexion test measures isometric maximum voluntary contraction (MVC) in sitting position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip extension strength using a dynamometer with external belt-fixation (continuous data)	Isometric hip extension test measures isometric maximum voluntary contraction (MVC) in prone position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in isometric hip abduction strength using a dynamometer with external belt-fixation (continuous data)	Isometric hip abduction test measures isometric maximum voluntary contraction (MVC) in supine position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported acceptable symptom state using the Patient Acceptable Symptom State (PASS) (dichotome data)	PASS measures perceived state of current hip and/or groin symptoms by the following question: Taking into account all the activities the patients are doing in their daily life, their level of pain, and also their functional impairments, do the patients consider that their current state of symptoms is acceptable (yes/no)?	Measured at 6- and 12-month follow-up
Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)	Hip and/or groin pain is measured on an electronic VAS from 0 to 100 mm within the last week.	From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain during physical activity (continuous data)	Hip and/or groin pain is measured on an electronic VAS from 0 to 100 mm within the last week.	From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
Change in self-reported back pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)	Back pain is measured on an electronic VAS from 0 to 100 mm within the last week.	From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
Change in self-reported back pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in activity (continuous data)	Back pain is measured on an electronic VAS from 0 to 100 mm within the last week.	From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
Change in self-reported hip and/or groin pain during hip flexion strength test measured on a numerical rating scale (NRS) for pain (categorical data)	Hip and/or groin is measured immediately after isometric hip flexion strength test	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in self-reported hip and/or groin pain during hip extension strength test measured on a numerical rating scale (NRS) for pain (categorical data)	Hip and/or groin is measured immediately after isometric hip extension strength test	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in self-reported hip and/or groin pain during hip abduction strength test measured on a numerical rating scale (NRS) for pain (categorical data)	Hip and/or groin is measured immediately after isometric hip abduction strength test	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in self-reported usage of analgesics (y/n/type/dose)	Analgesics include paracetamol/acetaminophen, ibuprofen and other NSAIDs, and morphine/opioids.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Number of serious adverse events (SAE) and adverse events (AE) related to the interventions, clinical assessments or conduct of the trial within the intervention period (continuous data)	SAE and AE that may occur within the intervention period will be identified in different ways: by self-reporting by the patients and by observation from the intervention providers and test physiotherapists. Furthermore, a short patient-reported questionnaire at the 3- and 6- month follow-up will be used to ensure that all SAE and AE requiring medical treatment will be recorded. In addition, the included patients will be encouraged to report health issues and injuries affecting adherence to allocated treatments to the principal investigator within the intervention period.	From baseline to 6-month follow-up.
Adherence measured by the 6-item Exercise Adherence Rating Scale (EARS) (continuous data)	Adherence is scored on a scale from 0 to 24 points by the patients, 24 indicating full adherence	From baseline to 6-month follow-up. Outcome measured at 3- and 6-month follow-up
Adherence measured at number of completed training sessions (continuous data)	Number of completed training sessions is reported prospectively by the patients in standardised registration forms (range 0-78)	From baseline to 6-month follow-up. Outcome measured every week.
Change in quality-adjusted life years (QALYs) measured with EuroQoL 5-dimension (EQ-5D-5L) and valued using preference weights (continuous data)	The EQ-5D-5L is a five-item patient-reported outcome measure designed to assess generic health-related quality-of-life. We will used the UK value set in this study, because a Danish value set is not yet available. These values range from -0.285 to 1.0, a value of 1.0 corresponds to full health, 0 corresponds to death and negative values correspond to health status considered to be worse than death. QALYs will be reported in the health economic study.	From baseline to 12-month follow-up. Outcome measured at baseline, 3-, 6-, 9- and 12-month follow-up
Productivity loss measured with Productivity Costs Questionnaire (IPCQ) (continuous data)	The IPCQ questionnaire includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. Productivity loss will be reported in the health economic study.	From baseline to 6-month follow-up. Outcome measured at baseline, 3-, 6-, 9- and 12-month follow-up
Change in muscle-tendon pain in the iliopsoas measured with a pain-provocation test (dichotomous data)	The iliopsoas pain-provocation test measured known pain palpatory pain in the muscle through the lower lateral part of the abdomen and/or just distal to the inguinal ligament. Muscle-tendon pain will be reported in a secondary paper.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in muscle-tendon pain in the abductors measured with a pain-provocation test (dichotomous data)	The abductor pain-provocation test measured known palpatory pain at the insertion point at the greater trochanter and pain with side-lying abduction against resistance. Muscle-tendon pain will be reported in a secondary paper.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in temporal summation of pain (TS) at the hip (continuous data)	TS measures increase in pain recorded on a numerical rating scale (NRS) (range 0-10) as the difference in pain rating between a single pinprick stimuli and a train of 10 pinprick stimuli applied to the rectus femoris muscle. TS will be reported in a secondary paper.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in temporal summation of pain (TS) at the forearm (continuous data)	TS measures increase in pain recorded on a numerical rating scale (NRS) (range 0-10) as the difference in pain rating between a single pinprick stimuli and a train of 10 pinprick stimuli applied to the forearm. TS will be reported in a secondary paper.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in pressure pain threshold (PPT) at the hip (continuous data)	PPT measures first sensation of pain when increasing pressure is applied with an algometer at the rectus femoris muscle, reported as kPa. PPT will be reported in a secondary paper.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in pressure pain threshold (PPT) at the forearm (continuous data)	PPT measures first sensation of pain when increasing pressure is applied with an algometer at the forearm, reported as kPa. PPT will be reported in a secondary paper.	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Change in osteoarthritis grade measured by the Tönnis osteoarthritis classification (categorical data)	Tönnis osteoarthritis classification grade degree of osteoarthritis from 0-3, and 0 indicates no signs of osteoarthritis and 3 indicates severe osteoarthritis described by large cysts, severe narrowing of the joint space, severe femoral head deformity, and avascular necrosis	From baseline to 5- and 10-years follow-up. Outcome measured at baseline and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Number of other treatments received by the patients (number and text)	Self-reported and registry-based data	From baseline to 12-month follow-up (Health economic study). Outcome measured at 3- 6-, 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Trust in the capability of the hip with a 100 mm Visual Analog Scale (0-100, 100 best) for trust during the single-leg hop for distance test (continuous data)	Trust in the capability is measured immediately after the single-leg hop for distance test	From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University of Aarhus; VIA University College; Research Unit for General Practice, Aarhus University; Copenhagen University Hospital, Hvidovre; Defactum, Central Denmark Region
• Investigators: Principal Investigator: Julie S Jacobsen, PhD, VIA University College; Study Director: Inger Mechlenburg, DMSc, Aarhus University Hospital; Study Chair: Kristian Thorborg, PhD, Copenhagen University Hospital, Hvidovre; Study Chair: Rasmus Ø Nielsen, PhD, University of Aarhus; Study Chair: Stig S Jakobsen, PhD, Aarhus University Hospital; Study Chair: Lisa G Oestergaard, PhD, Defactum, Central Denmark Region; Study Chair: Kjeld Søballe, PhD, Aarhus University Hospital

Publications and helpful links

General Publications

• Jacobsen JS, Thorborg K, Nielsen RO, Jakobsen SS, Foldager C, Sorensen D, Oestergaard LG, van Tulder MW, Mechlenburg I. Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial). BMJ Open. 2022 Sep 20;12(9):e064242. doi: 10.1136/bmjopen-2022-064242.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Cost-effectiveness; Patient education; Effectiveness; Process evaluation; Usual care; Hip Dislocation, Congenital; Periacetabular osteotomy
• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: MovetheHip

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

What data will be shared: All quantitative individual participant data collected during the trial, after deidentification.

With whom will data be shared: Researchers who provide a methodologically sound proposal.

For what types of analyses: To achieve aims in the approved proposal.

The abovementioned is based on Data Sharing Statements for Clinical Trials: A Requirement of the ICMJE located at: http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf.

• IPD Sharing Time Frame: Immediately following publication and ending 5 years following primary article publication.
• IPD Sharing Access Criteria: Proposals should be directed to jsaj@via.dk. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No