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Bone & Joint 360
Vol. 12, Issue 4 | Pages 6 - 9
1 Aug 2023
Craxford S Marson BA Ollivere B


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 20 - 20
1 Jun 2023
Morrison S Formosa M Donnan L
Full Access

Introduction. Patient-reported outcome measures (PROMs) has gained momentum in the orthopaedic literature. The GOAL-LD (Gait Outcomes Assessment List for Limb Deformity) incorporates the framework of The WHO International Classification of Functioning, Disability and Health and correlates highly with the Paediatric Outcomes Data Collection Instrument (PODCI) when applied in a limb reconstruction setting. The Royal Children's Hospital Melbourne, Australia, supported by The University of Melbourne is designing and implementing a Limb Reconstruction Registry, prospectively enrolling patients with a number of key conditions and provide a mechanism for capturing surgical data and PROMs at regular follow-up intervals. LimbDREAM (The Limb Reconstruction Registry of Experience, Aspiration and Measures) has begun recruiting participants, and this paper serves as a narrative review of our design and implementation process. Materials & Methods. After provision of a research grant, audit was conducted to examine local case mix and estimate recruitment based on conditions selected. Literature review was focussed on (i) registries in the paediatric limb reconstruction domain and (ii) use of PROMs across conditions selected. A high-level process-flow chart was constructed in order to inform governance and staffing requirements in addition to REDCap Database structure. Local as well as scalable deployment was considered. Alpha and beta testing was performed by principal and associate investigators prior to participant recruitment. Results. Audit identified 6 condition streams for inclusion: Congenital limb deficiencies, congenital pseudarthrosis of the tibia, bone dysplasias, bone tumours, amputation, and complex deformity of other etiology. Literature review identified 20 PROMs used across these conditions, with limited validation studies and significant implementation heterogeneity. REDCap database design took longer than anticipated (planned 10 months, actual 18 months) before being recruitment ready, due to the complexity of ensuring data collection logic would work across highly diverse patient journeys. Initial recruitment across all streams has been promising. Email and text message reminders have proved helpful in increasing survey return rates. Conclusions. Prospective collection of PROMs as well as surgical data via a standardized dataset will provide the basis for future condition-specific research, with the ability to support nested trials. Implementation requires forethought with regard to time frames and staffing for non-automated steps as well as data integrity review. The next phase of the LimbDREAM project will be to integrate use of the Registry into our weekly Limb Reconstruction Meeting to ensure that operative plans and data are captured close to the point of care


Aims

To systematically review the efficacy of split tendon transfer surgery on gait-related outcomes for children and adolescents with cerebral palsy (CP) and spastic equinovarus foot deformity.

Methods

Five databases (CENTRAL, CINAHL, PubMed, Embase, Web of Science) were systematically screened for studies investigating split tibialis anterior or split tibialis posterior tendon transfer for spastic equinovarus foot deformity, with gait-related outcomes (published pre-September 2022). Study quality and evidence were assessed using the Methodological Index for Non-Randomized Studies, the Risk of Bias In Non-Randomized Studies of Interventions, and the Grading of Recommendations Assessment, Development and Evaluation.


Bone & Joint Open
Vol. 4, Issue 2 | Pages 87 - 95
10 Feb 2023
Deshmukh SR Kirkham JJ Karantana A

Aims. The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Methods. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set. Results. The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as ‘very important’ for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result. Conclusion. This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries. Cite this article: Bone Jt Open 2023;4(2):87–95


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 792 - 800
1 Jul 2022
Gustafsson K Kvist J Zhou C Eriksson M Rolfson O

Aims

The aim of this study was to estimate time to arthroplasty among patients with hip and knee osteoarthritis (OA), and to identify factors at enrolment to first-line intervention that are prognostic for progression to surgery.

Methods

In this longitudinal register-based observational study, we identified 72,069 patients with hip and knee OA in the Better Management of Patients with Osteoarthritis Register (BOA), who were referred for first-line OA intervention, between May 2008 and December 2016. Patients were followed until the first primary arthroplasty surgery before 31 December 2016, stratified into a hip and a knee OA cohort. Data were analyzed with Kaplan-Meier and multivariable-adjusted Cox regression.


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims

The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures.

Methods

A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 135 - 135
1 Jul 2020
Xu M Johnson MG Zarrabian M
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There is evidence that preoperative physical fitness impacts surgical outcomes, specifically preceding abdominal, cardiovascular and spine surgery. To our knowledge, there are no papers on self-reported exercise frequency as a predictor of cervical spine surgery outcomes. Our objectives were to quantify self-report of exercise frequency in cervical spine surgery patients, and to elucidate if self-reported exercise prior to surgery confers less pain, improved health state and/or less disability post-surgery. We performed a retrospective review of prospectively collected data from the Canadian Spine Outcomes and Research Network (CSORN) Database from the time of its inception. Inclusion criteria specified all elective cervical surgery patients over 18 years old with degenerative pathology who proceeded to surgery and completed the pre- and post-operative outcomes measures up to 24 months post surgery (n=460). Outcome measures were visual analog scales (VAS) for neck and arm pain, Neck Disability Index (NDI), and EuroQOL score at baseline and 3, 12 and 24 months post-op. Exercise frequency was self-reported as “none” (n=212) versus “some” (n=248). These groups were further categorized into “none due to physical limitations”, “none” (not due to physical limitations), those to exercised “once or less per week” and those that exercised “twice or more per week”. Student's t-tests were used to compare the mean scores of the outcome measures, and analysis of variance for subgroup comparisons, with results considered significant at p < 0 .05. At baseline, 56% of total patients reported exercise prior to surgery, of which 73% reported doing so twice or more per week. Of the 44% reporting no exercise, 74% could not exercise due to physical limitations. Those who reported “some” exercise had more favorable VAS neck and arm pain scores pre-operatively (neck: 5.55 vs 6.11, p < 0 .001) (arm: 5.69 vs 6.04, p=0.011), but no difference at 3 and 24 months post-operatively. Significantly lower NDI scores and higher EuroQOL Index scores were seen in the exercise group compared to the no exercise group pre-operatively (NDI: 39 vs 48, p < 0 .001) (EuroQOL: 0.60 vs 0.50 p < 0 .001) as well as at 3, 12, and 24 months post-op (NDI: 24 vs 31, p=0.007) (EuroQOL: 0.75 vs 0.68, p=0.001). Further subgroup analysis demonstrated that compared to the “no exercise due to physical limitation” group, the “twice or more” exercise group showed favorable NDI and EuroQOL scores up to 24 months post-op (NDI: 24.32 vs 32.33, p=0.001) (EuroQOL: 0.76 vs 0.66, p=0.001), whereas the “once or less times per week” group no longer demonstrated any significant difference at 24 months (NDI: 28.79 vs 32.33, p=1) (EuroQOL: 0.73 vs 0.66, p=0.269). Self-reported exercise prior to cervical spine surgery does not predict improved long-term neck and arm pain at 2 years post-op. However, self-reported exercise does demonstrate less disability and improved health state at baseline and up to 2 years post-op and this relationship is dose dependent


Bone & Joint Open
Vol. 1, Issue 5 | Pages 167 - 174
31 May 2020
Marson BA Craxford S Deshmukh SR Grindlay D Manning J Ollivere BJ

Aims. To analyze outcomes reported in trials of childhood fractures. Methods. OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classification of Function framework. Results. In all, 525 outcomes were identified representing 52 WHO domains. Four domains were reported in more than 50% of trials: structure of upper/lower limb, sensation of pain, mobility of joint function, and health services, systems and policies. The Activities Scale for Kids performance (ASK-p) score was the most common outcome score reported in 6/72 upper limb and 4/28 lower limb trials. Conclusion. There is a diverse range of outcomes reported in trials of childhood fractures covering all areas in the International Classification of Functioning, Disability and Health (ICF) framework. There were three common upper limb and three common lower limb outcomes. In the absence of a core outcome set, we recommend that upper limb trials report pain, range of movement and radiograph appearance of the arm and lower limb trials report pain, radiograph appearance of the leg and healthcare costs to improve consistency of reporting in future trials. Cite this article: Bone Joint Open 2020;1-5:167–174


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 33 - 33
1 Sep 2019
Dutmer A Reneman M Wolff A Soer R Preuper HS
Full Access

Introduction. A minority of patients with chronic low back pain (CLBP) account for a majority of disability and costs. This subgroup has potentially most to gain from effective treatment. The Groningen Spine Cohort will provide a 10-year prospective insight into the burden of CLBP for patients referred to multispecialty tertiary spine care in the Netherlands. This study reports first baseline results. Objective. To study the personal and societal impact of CLBP in patients visiting the UMCG tertiary spine center. Patients. Adult patients with CLBP. Methods. Patient-reported baseline questionnaire and health insurance costs one year prior to visiting the Spine Center. Primary outcomes: NIH minimal dataset Impact Stratification score (range 8–50), functioning (Pain Disability Index, PDI; 0–70), quality of life (EuroQol-5D, EQ5D; -0.33–1.00), work ability (single-item Work Ability Score, WAS; 0–10), work participation (absenteeism, disability), and health insurance costs. Descriptive statistics were applied. Results. N=1503 patients (age m=46.3, sd=12.8 years, 57% female) were included. NIH Impact Stratification m=35.2±7.5; severe impact (≥35) for 58% of patients. PDI = 38.2±14.1; EQ5D = 0.44±0.30; WAS = 3.8±2.9. Absenteeism: 43% of workers. Permanent work disability: 17%. Health insurance costs: med= €2432, IQR €4739. Discussion And Conclusions. In patients seeking multispecialty tertiary spine care, the personal and societal impact of CLBP is very high. Costs are substantially higher than what is already known about the burden of the average patient with CLBP. Clinical Message. More effective personalized stepped and matched care is urgently needed to reduce the burden of CLBP in a subgroup of patients seeking multispecialty tertiary spine care. No conflicts of interest. Sources of Funding: Funding from the University Medical Center Groningen


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 715 - 723
1 Jun 2019
Jayakumar P Teunis T Williams M Lamb SE Ring D Gwilym S

Aims

The purpose of this study was to identify factors associated with limitations in function, measured by patient-reported outcome measures (PROMs), six to nine months after a proximal humeral fracture, from a range of demographic, injury, psychological, and social variables measured within a week and two to four weeks after injury.

Patients and Methods

We enrolled 177 adult patients who sustained an isolated proximal humeral fracture into the study and invited them to complete PROMs at their initial outpatient visit within one week of injury, between two and four weeks, and between six to nine months after injury. There were 128 women and 49 men; the mean age was 66 years (sd 16; 18 to 95). In all, 173 patients completed the final assessment. Bivariate analysis was performed followed by multivariable regression analysis accounting for multicollinearity using partial R2, correlation matrices, and variable inflation factor.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 143 - 143
1 Apr 2019
Hillstrom R Morgan OJ Rozbruch SR Fragomen AT Ranawat A Hillstrom H
Full Access

Introduction. Osteoarthritis (OA), a painful, debilitating joint disease, often caused by excessive joint stress, is a leading cause of disability (World Health Organisation, 2003) and increases with age and obesity. A 5° varus malalignment increases loading in the medial knee compartment from 70% to 90% (Tetsworth and Paley, 1994). Internal unloading implants, placed subcutaneously upon the medial aspect of the knee joint, are designed to offload the medial compartment of the knee without violating natural joint tissues. The aim of this study is to investigate the effect of an unloading implant, such as the Atlas™ knee system, on stress within the tibiofemoral joint with different grades of cartilage defects. Methods. To simulate surgical treatment of medial knee OA, a three-dimensional computer-aided design of an Atlas™ knee system was virtually fixed to the medial aspect of a validated finite element knee model (Mootanah, 2014), using CATIA v5 software (Dassault Systèmes, Velizy Villacoublay, France). The construct was meshed and assigned material properties and boundary conditions, using Abaqus finite element software (Dassault Systèmes, Velizy Villacoublay, France). A cartilage defect was simulated by removing elements corresponding to 4.7 mm. 2. The international cartilage repair society (ICRS) Grade II and III damage were simulated by normalized defect depth of 33% and 67%, respectively. The femur was mechanically grounded and the tibia was subjected to loading conditions corresponding to the stance phase of walking of a healthy 50-year-old 68-Kg male with anthropometrics that matched those of the cadaver. Finite element analyses were run for peak shear and von Mises stress in the medial and lateral tibiofemoral compartments. Results. Von Mises stress distribution in the tibial cartilage, with ICRS Grade II and III defects, without the unloading implant, at the end of weight acceptance (15% of the gait cycle) were analysed. The internal unloading implant reduces peak von Mises stress by 40% and 43% for Grade II and Grade III cartilage defects, respectively. The corresponding reductions in shear stress are 36% and 40%. Consistent reduction in peak von Mises stress values in the medial cartilage-cartilage and cartilage-meniscus contact areas were predicted throughout the stance phase of the gait cycle for ICRS Grade II defect. Similar results were obtained for Grade III defect and for peak shear stress values. There were no overall increases in peak von Mises stress values in the lateral tibial cartilage. Discussion and Conclusions. The internal unloading implant is capable of reducing von Mises and shear stress values in the medial tibial cartilage with ICRS Grade II and III defects at the cartilage-cartilage and cartilage-meniscus interfaces throughout the stance phase of the gait cycle. This did not result in increased stress values in the lateral tibial cartilage. Our model did not account for the viscoelastic effects of the cartilage and meniscus. Results of this study are based on only one knee specimen. The internal unloading implant may protect the cartilage in individuals with medial knee osteoarthritis, thereby delaying the need for knee replacements


The Bone & Joint Journal
Vol. 101-B, Issue 3 | Pages 233 - 235
1 Mar 2019
Ollivere BJ Marson BA Haddad FS


Bone & Joint 360
Vol. 8, Issue 1 | Pages 40 - 42
1 Feb 2019


Bone & Joint 360
Vol. 8, Issue 1 | Pages 25 - 27
1 Feb 2019


The Bone & Joint Journal
Vol. 100-B, Issue 1 | Pages 119 - 124
1 Jan 2018
Broderick C Hopkins S Mack DJF Aston W Pollock R Skinner JA Warren S

Aims. Tuberculosis (TB) infection of bones and joints accounts for 6.7% of TB cases in England, and is associated with significant morbidity and disability. Public Health England reports that patients with TB experience delays in diagnosis and treatment. Our aims were to determine the demographics, presentation and investigation of patients with a TB infection of bones and joints, to help doctors assessing potential cases and to identify avoidable delays. Patients and Methods. This was a retrospective observational study of all adults with positive TB cultures on specimens taken at a tertiary orthopaedic centre between June 2012 and May 2014. A laboratory information system search identified the patients. The demographics, clinical presentation, radiology, histopathology and key clinical dates were obtained from medical records. Results. A total of 31 adult patients were identified. Their median age was 37 years (interquartile range (IQR): 29 to 53); 21 (68%) were male; 89% were migrants. The main sites affected were joints (10, 32%), the spine (8, 26%) and long bones (6, 19%); 8 (26%) had multifocal disease. The most common presenting symptoms were pain (29/31, 94%) and swelling (26/28, 93%). ‘Typical’ symptoms of TB, such as fever, sweats and weight loss, were uncommon. Patients waited a median of seven months (IQR 3 to 13.5) between the onset of symptoms and referral to the tertiary centre and 2.3 months (IQR 1.6 to 3.4.)) between referral and starting treatment. Radiology suggested TB in 26 (84%), but in seven patients (23%) the initial biopsy specimens were not sent for mycobacterial culture, necessitating a second biopsy. Rapid Polymerase Chain Reaction-based testing for TB using Xpert MTB/RIF was performed in five patients; 4 (80%) tested positive for TB. These patients had a reduced time between the diagnostic biopsy and starting treatment than those whose samples were not tested (median eight days versus 36 days, p = 0.016). Conclusion. Patients with bone and joint TB experience delays in diagnosis and treatment, some of which are avoidable. Maintaining a high index of clinical suspicion and sending specimens for mycobacterial culture are crucial to avoid missing cases. Rapid diagnostic tests reduce delays and should be performed on patients with radiological features of TB. Cite this article: Bone Joint J 2018;100-B:119–24


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_2 | Pages 1 - 1
1 Feb 2015
Stynes S Konstantinou K Dunn K
Full Access

Background. Leg pain frequently accompanies low back pain and is associated with increased levels of disability and higher health costs than simple low back pain. Distinguishing between different types of low back- related leg pain (LBLP) is important for clinical management and research applications. The aim of this systematic review was to identify, describe and appraise papers that classify or subgroup populations with LBLP. Methods. The search strategy involved nine electronic databases including Medline and Embase, reference lists of eligible studies and relevant reviews. Selected papers were quality appraised independently by two reviewers using a standardised scoring tool. Results. Of 13,337 potential eligible citations, 49 relevant papers were identified that reported on 20 classification systems. Papers were grouped according to purpose and criteria of the classification systems. Five themes emerged: (i) pathoanatomical sources of pain (ii) clinical features, (iii) pain mechanisms, (iv) treatment based approach and (v) screening tools and prediction rules. Four of the twenty systems focused specifically on LBLP populations. Pain mechanisms and treatment based approach systems scored highest following quality appraisal as authors generally included statistical methods to develop their classifications and supporting work had been published on the systems' validity, reliability and generalizability. Conclusion. Numerous classification systems exist that include patients with leg pain, a minority of them focus specifically on distinguishing between different presentations of leg pain. Further work is needed to identify clinically meaningful subgroups of LBLP patients, ideally based on large primary care cohort populations and using stringent methods for classification system development. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting. Conflicts of interest: No conflicts of interest. S Stynes is supported by an NIHR/HEE Clinical Doctoral Research Fellowship. Dr Konstantinou is supported by an HEFCE/NIHR Senior Clinical Lectureship. Professor Dunn is supported by the Wellcome Trust (083572)


The Bone & Joint Journal
Vol. 97-B, Issue 1 | Pages 3 - 9
1 Jan 2015
Hossain FS Konan S Patel S Rodriguez-Merchan EC Haddad FS

The routine use of patient reported outcome measures (PROMs) in evaluating the outcome after arthroplasty by healthcare organisations reflects a growing recognition of the importance of patients’ perspectives in improving treatment. Although widely embraced in the NHS, there are concerns that PROMs are being used beyond their means due to a poor understanding of their limitations.

This paper reviews some of the current challenges in using PROMs to evaluate total knee arthroplasty. It highlights alternative methods that have been used to improve the assessment of outcome.

Cite this article: Bone Joint J 2015;97-B:3–9.


Bone & Joint 360
Vol. 2, Issue 3 | Pages 29 - 31
1 Jun 2013

The June 2013 Spine Roundup360 looks at: the benefit of MRI in the follow-up of lumbar disc prolapse; gunshot injury to the spinal cord; the link between depression and back pain; floating dural sack sign; short segment fixation at ten years; whether early return to play is safer than previously thought; infection in diabetic spinal patients; and dynesis.


Bone & Joint Research
Vol. 2, Issue 6 | Pages 116 - 121
1 Jun 2013
Duijnisveld BJ Saraç Ç Malessy MJA Brachial Plexus Advisory Board TI Vliet Vlieland TPM Nelissen RGHH

Background

Symptoms of obstetric brachial plexus injury (OBPI) vary widely over the course of time and from individual to individual and can include various degrees of denervation, muscle weakness, contractures, bone deformities and functional limitations. To date, no universally accepted overall framework is available to assess the outcome of patients with OBPI. The objective of this paper is to outline the proposed process for the development of International Classification of Functioning, Disability and Health (ICF) Core Sets for patients with an OBPI.

Methods

The first step is to conduct four preparatory studies to identify ICF categories important for OBPI: a) a systematic literature review to identify outcome measures, b) a qualitative study using focus groups, c) an expert survey and d) a cross-sectional, multicentre study. A first version of ICF Core Sets will be defined at a consensus conference, which will integrate the evidence from the preparatory studies. In a second step, field-testing among patients will validate this first version of Core Sets for OBPI.