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The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1306 - 1311
1 Nov 2024
Watts AC McDaid C Hewitt C

Aims

A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement.

Methods

A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 70 - 70
1 Mar 2021
Mate K Goulding K Košir U Tsimicalis A Turcotte R Freeman C Alcindor T Mayo N
Full Access

The patient's subjective experience of disease is an increasing focus in health care delivery. Health-related quality of life (HRQoL) is defined as a “functional effect of a medical condition and its consequent treatment”; it is both self-reported and multi-dimensional. While functional outcome is well researched among the soft tissue sarcoma (STS) population, few studies have focused on HRQoL, which gives a broader understanding of the psychological, somatic, social and physical toll of cancer and its treatment from the patient's viewpoint. The biologic and anatomic heterogeneity of sarcomas are considerable, just as the treatments are diverse, we surmise that the indicators of patient HRQoL differ and are not captured in existing generic HRQoL tools for cancer. The study objectives were to explore the domains of HRQoL and functioning in adult patients diagnosed with extremity STS from the patient's perspective from active care through survivorship through qualitative inquiry, so as to form the basis for the development of a patient-derived, sarcoma-specific, preference based HRQoL tool.

Study design is a sequential exploratory mixed methods study of patient experience in localized or metastatic adult extremity STS (2007 and 2017). The study was conducted at a high-volume sarcoma centre. Qualitative descriptive design was grounded in an integrated knowledge translation approach and aimed at identifying HRQoL domains through in-person and electronic focus groups, and individual semi-structured interviews in both English and French (N=28). The interview guide topics were selected based on existing knowledge about PROs and HRQoL life, including (a) impact of diagnosis on employment or acquisition of academic/vocational skills; (b) physical and psychological functioning; (c) symptom burden; (d) treatment preferences; (e) knowledge of and use of existing resources; (f) impact on family time and resources; and (g) overall experience. Data was analyzed using inductive thematic networks approach using the qualitative software N-Vivo 12. Codes were generated by 2 independent qualitative experts capturing key concepts of HRQoL that is impacted by STS. Basic themes were clustered into organizing themes, and merged into global domains. Attention was paid to deviant cases and within-group dynamics during focus group discussion analysis. Discrepancies or inconsistencies in coding were resolved in consensus meetings. Final sample size was determined when data saturation was reached and no new themes emerged. Qualitative reduction of identified items to reach a consensus framework was facilitated by a moderator during multi-disciplinary panel meetings comprised of sarcoma experts, patient partners, allied health staff and other stakeholders.

Twenty-nine patients with biopsy-proven localized or metastatic STS of the extremity participated (69% lower extremity STS; mean age 56 years, 25% with local recurrence, 21% metastatic, 18% amputation). Inductive thematic network analysis revealed five function-related domains HRQoL for patients with STS. The functional domains were mapped to the Wilson & Cleary Model and experience domains were mapped to the Picker Institute's Through Patient's Eyes model.

This is a critical step toward developing disease specific outcome measures. Patient-centered research is crucial to understanding the impact of surgery, adjuvant therapy and the associated complications for patients with extremity STS, and thereby improving the quality of care provision. This study offers a unique perspective on what domains and sub domains are most impactful on HRQoL and provides the basis for our on-going development of a disease-specific, preference-based HRQoL measure.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 20 - 20
1 Dec 2022
O'Connor K Zwicker J Chhina H Cooper A
Full Access

A huge commitment is required from patients and families who undergo a limb reconstruction procedure using the hexapod frame. This includes turning the struts on the frame, pin site care and intensive rehabilitation. Montpetit et al (2009) discovered that function, participation, engagement in regular activities of daily living is severely impacted during the hexapod lengthening period. Due to the long duration and burden for families, it is imperative that healthcare professionals understand the impact that the hexapod frame has on functional abilities and health related quality of life (HRQL).

This project involved a retrospective review of prospectively collected data on function and HRQL during two periods of time: (1) when the hexapod frame is applied on the child's lower extremity and (2) when the lengthening phase is completed, and the hexapod frame is removed. Data from 38 children (mean age: 12 years SD 3.8) who completed lower extremity reconstruction using the hexapod frame and completed either or both the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) and Pediatric Outcomes data Collection Instrument (PODCI) was included. Analysis included, standardized response means, the non-parametric Wilcoxon test and effect size calculation.

A Wilcoxon signed rank test for those children who completed pre and post frame PODCI’;s revealed those scores were significantly greater once the hexapod frame was removed (Md=85.10, n=10) compared to during (Md=66.50, n=10) with a large effect size, r= 1.45. Similar, the PedsQL scores improved post frame removal (Md= 66.30, n=10) compared to during treatment (Md = 53.34, n=10), with a medium size effect, r= 0.62. All subtests improved once the frame was removed.

This study provides essential insights into the burden of the hexapod frame for children and provides valuable information for all allied healthcare professionals targeted interventions for health domains. This study shows that children's function improves once the hexapod frame is removed. However, this study highlights the importance for all healthcare professional to address health domains for the duration of the hexapod procedure where the child scored lower e.g. sports and physical function, pain and comfort, happiness from the PODCI. The PedsQL identified lower mean scores in physical and emotional function.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 13 - 13
1 Oct 2019
Husted M Rossen C Jensen T Mikkelsen L Rolving N
Full Access

Background and purpose

Adherence to clinical guidelines produces greater improvement in disability in patients with low back pain (LBP), but a wide variation in physiotherapists' adherence has been documented repeatedly. The aim of the study was to investigate the adherence to National Clinical Guidelines for LBP among Danish physiotherapists with regard to three key guideline domains: 1) activity, 2) work, and 3) psychosocial risk factors. Additionally to investigate whether adherence differed between physiotherapists working in private clinics and physiotherapists working at public healthcare centres.

Methods

A cross-sectional online survey was conducted with 817 Danish physiotherapists. Adherence to the three guideline domains was assessed using two vignettes. The difference in adherence between the groups was assessed using the chi-squared test.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_16 | Pages 8 - 8
1 Apr 2013
Hoang-Kim A Goldhahn J Beaton D Macdermid J Ladd A
Full Access

Introduction

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We report on the progress on establishing a minimal set of core domains for outcome measurement in distal radius fracture.

Materials and methods

Participants included an expert panel of orthopaedic surgeons, outcome researchers, patients, physiotherapists, industry representatives involved in distal radius research and partners in regulatory affairs. Decisions were made by review of evidence and theory and establishing group consensus.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 1 - 1
1 Oct 2022
Paskins Z Le Maitre C Farmer C Clark E Mason D Wilkinson C Andersson D Bishop F Brown C Clark A Jones R Loughlin J McCarron M Pandit H Richardson S Salt E Taylor E Troeberg L Wilcox R Barlow T Peat G Watt F
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Background. Involving research users in setting priorities for research is essential to ensure research outcomes are patient-centred and to maximise research value and impact. The Musculoskeletal (MSK) Disorders Research Advisory Group Versus Arthritis led a research priority setting exercise across MSK disorders. Methods. The Child Health and Nutrition Research Initiative (CHRNI) method of setting research priorities with a range of stakeholders were utilised. The MSKD RAG identified, through consensus, four research Domains: Mechanisms of Disease; Diagnosis and Impact; Living Well with MSK disorders and Successful Translation. Following ethical approval, the research priority exercise involved four stages and two surveys, to: 1) gather research uncertainties; 2) consolidate these; 3) score uncertainties using agreed criteria of importance and impact on a score of 1–10; and 4) analyse scoring, for prioritisation. Results. The first survey had 209 respondents, who described 1290 research uncertainties, which were refined into 68 research questions. 285 people responded to the second survey. The largest group of respondents represented patients and carers, followed by researchers and healthcare professionals. A ranked list was produced, with scores ranging between 12 and 18. Key priorities included developing and testing new treatments, better targeting of treatments, early diagnosis, prevention and better understanding and management of pain, with an emphasis on understanding underpinning mechanisms. Conclusions. For the first time, we have summarised priorities for research across MSKD, from discovery science to applied clinical and health research, including translation. We present a call to action to researchers and funders to target these priorities. Conflict of Interest: None. Sources of funding: We thank the funder, Versus Arthritis for their support of the research advisory groups and this activity


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 36 - 36
1 Feb 2014
Matthews J Hall A Lonsdale C Hernon M Murray A Taylor I Jackson B Toner J Guerin S Hurley DA
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Purpose of the study and background. The CONNECT trial evaluated a theory-based intervention to increase low back pain patients' adherence to treatment recommendations through physiotherapists' communication behaviour. Bridging the gap between evidence and evidence-based practice, we aimed to develop an implementation intervention to support physiotherapists in translating the CONNECT communication training into practice. Methods and results. A systematic approach was used to develop this intervention. 1. Focus groups underpinned by the Theoretical Domains Framework were conducted to assess CONNECT trained physiotherapists' (n = 9) perceptions of the barriers and enablers to implementing these strategies in practice; the results of which yielded four main domains; two related to factors outside the individual (i.e. social influences and environmental resources), and two related to individuals' motivation and capabilities (i.e. self –efficacy and behavioural regulation). 2. Intervention components (i.e., behavior change techniques (BCT) and mode of delivery) were chosen. BCTs were mapped to the identified domains (e.g., the BCT of self-monitoring mapped to the self-efficacy domain) and audit and feedback focused coaching was selected as the main mode of delivery based on empirical evidence and feasibility. 3. Outcome measures were selected to evaluate the proposed changes in physiotherapist practice (i.e., Health Care Climate Questionnaire). This intervention was trialed with physiotherapists (n = 2) using a case-study design. Results from patient consultation audio-recordings and follow-up interviews revealed this intervention supported the translation of evidence-based training into practice and is considered feasible and acceptable to physiotherapists. Conclusion. Findings provide support for the systematic development and implementation of an intervention to translate evidence-based communication training into practice


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_6 | Pages 6 - 6
1 Apr 2014
Urquhart D Gallella S Brady E Blacklock S Tsirikos A
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Background:. Long-Term Follow-Up Of Lung Function And Quality Of Life (Qol) In Those Undergoing Combined Anterior And Posterior Spinal Fusion (A/Psf) For Ais Is Not Well Documented With Only One Study Extending Beyond 2 Years. Aim:. To Evaluate Long-Term Change In Pulmonary Function And Qol Following A/Psf For Ais. Methods:. Patients Who Underwent A/Psf For Ais From 2005–2007 Were Prospectively Studied (2011/2012). Lung Function [Forced Expiratory Volume In 1 Second (Fev1) And Forced Vital Capacity (Fvc)] Was Performed Along With Qol (Srs-22 Questionnaire). Paired T-Test Was Used To Compare Pre- And Post-A/Psf Data. Results:. Paired Pre- And Post-A/Psf Data Were Available For 12 Patients Who Underwent A/Psf At Mean(Range) 13.8(11.8–15) Years. 9/12 Were Female. Mean(Range) Follow-Up Was 5.8(4.1–6.7) Years Post-Operatively. Height Increased From Mean (Sd) 169(9) Cm. Pre-Operatively To 175(5) Cm. At Follow-Up (P<0.01). Scoliosis Corrected From 100(15) To 29(11) Degrees (P<0.001). %Predicted Fev1 Was 60(19) Pre-Operatively Versus 62(19) Post-Operatively (P=0.32); And Fvc Was 62(19) Pre-And 64(13) Post-A/Psf (P=0.67). Overall Srs-22 Scores Improved From Baseline Mean(Sd) 3.6(0.3) To 4.6(0.4) Post-Operatively (P<0.001). Improvements In Srs-22 Domains For Function [3.9(0.2) Vs. 4.9(0.2), P<0.001], Pain [3.5(0.4) Vs. 4.5(0.5), P<0.001], Self-Image [3.3(0.3) Vs. 4.4(0.5), P<0.001] And Mental Health [3.7(0.5) Vs. 4.4(0.6), P<0.001] Were Also Noted. High Patient Satisfaction Rates [4.8(0.3)] Were Recorded. No Correlation Was Noted Between Changes In Fev1 (R=0.08, P=0.8) Or Fvc (R=0.01, P=0.97) And Change In Srs-22 Score. Conclusion:. Long-Term Follow-Up Of Ais Patients Suggests No Deficit In Pulmonary Function, Whilst Quality Of Life And Patient Satisfaction Are High 6 Years After Combined A/Psf. Conflict Of Interest Statement: No conflict of interest


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 37 - 37
1 May 2012
Osborne R Bucknill A De Steiger R Brand C Graves S
Full Access

As there is currently no evidenced-based and systematic way of prioritising people requiring JRS we aimed to develop a clinically relevant system to improve prioritisation of people who may require JRS. An important challenge in this area is to accurately assign a queue position and improve list management. To identify priority criteria areas eight workshops were held with surgeons and patients. Domains derived were pain, activity limitations, psychosocial wellbeing, economic impact and deterioration. Draft questions were developed and refined through structured interviews with patients and consultation with consultants. 38 items survived critical appraisal and were mailed to 600 patients. Eleven items survived clinimetric and statistical item reduction. Validation then included co-administration with standardised questionnaires (960 patients), verification of patient MAPT scores through clinical interview, examination of concordance with surgeon global ratings and test-retest. Ninety-six Victorian surgeons weighted items using Discrete Choice Experiments (DCEs). The DCE scaling generated a scale, which clearly ranked patients across the disease continuum. The MAPT differentiated people on or not on waiting lists (p<0.001), and was highly correlated with other questionnaires, e.g., unweighted-MAPT vs WOMAC (r=0.78), Oxford Hip/Knee (r=0.86/0.75), Quality of Life (r=0.78), Depression (r=0.64), Anxiety (r=0.60), p<0.001 for all. Test-retest was excellent (ICC=0.89, n=90). Cronbachs reliability was also high 0.85. The MAPT is now routinely administered across all Victorian hospitals undertaking arthroplasty where the response rate is generally above 90%. In the hands of clinicians the MAPT has been used to facilitate fast-tracking of patients with the greatest need, monitoring for deterioration in those waiting for surgery or having a trial of non-operative treatment and deferment of surgery for those that may benefit from further non-operative treatments. The MAPT is short, easy to complete and clinically relevant. It is a specific measure of severity of hip/knee arthritis and assigns priority for surgery. It has excellent psychometric and clinimetric properties evidenced by concordance with standard disease-specific and generic scales and widespread use and endorsement across health services


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 277 - 285
1 Mar 2024
Pinto D Hussain S Leo DG Bridgens A Eastwood D Gelfer Y

Aims

Children with spinal dysraphism can develop various musculoskeletal deformities, necessitating a range of orthopaedic interventions, causing significant morbidity, and making considerable demands on resources. This systematic review aimed to identify what outcome measures have been reported in the literature for children with spinal dysraphism who undergo orthopaedic interventions involving the lower limbs.

Methods

A PROSPERO-registered systematic literature review was performed following PRISMA guidelines. All relevant studies published until January 2023 were identified. Individual outcomes and outcome measurement tools were extracted verbatim. The measurement tools were assessed for reliability and validity, and all outcomes were grouped according to the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT) filters.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 793 - 799
20 Sep 2024
Cederqvist S Flinkkilä T Tuominen A Sormaala M Ylinen J Kautiainen H Sirniö K Pamilo K Kiviranta I Paloneva J

Aims

Rotator cuff disease (RCD) can considerably decrease quality of life. Here, we investigated whether health-related quality of life (HRQoL) influences the need for surgery in patients with RCD.

Methods

We performed an analysis of 417 patients with symptomatic RCD who were recruited from two hospitals between June 2008 and December 2014 to be randomized to receive non-surgical or surgical treatment. After a three-month rehabilitation period, 36-Item Short-Form Health Survey questionnaire (SF-36), shoulder pain (visual analogue scale (VAS)), and shoulder function (Constant-Murley score) data were available from 191 still-symptomatic patients who were eligible for surgery. A control group was formed from 87 excluded patients who were no longer eligible for surgery due to relief of symptoms.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 501 - 507
1 May 2024
Galloway AM Keene DJ Anderson A Holton C Redmond AC Siddle HJ Richards S Perry DC

Aims

The aim of this study was to produce clinical consensus recommendations about the non-surgical treatment of children with Perthes’ disease. The recommendations are intended to support clinical practice in a condition for which there is no robust evidence to guide optimal care.

Methods

A two-round, modified Delphi study was conducted online. An advisory group of children’s orthopaedic specialists consisting of physiotherapists, surgeons, and clinical nurse specialists designed a survey. In the first round, participants also had the opportunity to suggest new statements. The survey included statements related to ‘Exercises’, ‘Physical activity’, ‘Education/information sharing’, ‘Input from other services’, and ‘Monitoring assessments’. The survey was shared with clinicians who regularly treat children with Perthes’ disease in the UK using clinically relevant specialist groups and social media. A predetermined threshold of ≥ 75% for consensus was used for recommendation, with a threshold of between 70% and 75% being considered as ‘points to consider’.


Bone & Joint Research
Vol. 12, Issue 4 | Pages 294 - 305
20 Apr 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims

Open lower limb fracture is life-changing, resulting in substantial morbidity and resource demand, while inconsistent outcome-reporting hampers systematic review and meta-analysis. A core outcome set establishes consensus among key stakeholders for the recommendation of a minimum set of outcomes. This study aims to define a core outcome set for adult open lower limb fracture.

Methods

Candidate outcomes were identified from a previously published systematic review and a secondary thematic analysis of 25 patient interviews exploring the lived experience of recovery from open lower limb fracture. Outcomes were categorized and sequentially refined using healthcare professional and patient structured discussion groups. Consensus methods included a multi-stakeholder two-round online Delphi survey and a consensus meeting attended by a purposive sample of stakeholders, facilitated discussion, and voting using a nominal group technique.


Bone & Joint Research
Vol. 13, Issue 5 | Pages 201 - 213
1 May 2024
Hamoodi Z Gehringer CK Bull LM Hughes T Kearsley-Fleet L Sergeant JC Watts AC

Aims

The aims of this study were to identify and evaluate the current literature examining the prognostic factors which are associated with failure of total elbow arthroplasty (TEA).

Methods

Electronic literature searches were conducted using MEDLINE, Embase, PubMed, and Cochrane. All studies reporting prognostic estimates for factors associated with the revision of a primary TEA were included. The risk of bias was assessed using the Quality In Prognosis Studies (QUIPS) tool, and the quality of evidence was assessed using the modified Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. Due to low quality of the evidence and the heterogeneous nature of the studies, a narrative synthesis was used.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1599 - 1607
1 Dec 2020
Marson BA Craxford S Deshmukh SR Grindlay DJC Manning JC Ollivere BJ

Aims

This study evaluates the quality of patient-reported outcome measures (PROMs) reported in childhood fracture trials and recommends outcome measures to assess and report physical function, functional capacity, and quality of life using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) standards.

Methods

A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant systematic review of OVID Medline, Embase, and Cochrane CENTRAL was performed to identify all PROMs reported in trials. A search of OVID Medline, Embase, and PsycINFO was performed to identify all PROMs with validation studies in childhood fractures. Development studies were identified through hand-searching. Data extraction was undertaken by two reviewers. Study quality and risk of bias was evaluated by COSMIN guidelines and recorded on standardized checklists.


Bone & Joint Open
Vol. 1, Issue 8 | Pages 457 - 464
1 Aug 2020
Gelfer Y Hughes KP Fontalis A Wientroub S Eastwood DM

Aims

To analyze outcomes reported in studies of Ponseti correction of idiopathic clubfoot.

Methods

A systematic review of the literature was performed to identify a list of outcomes and outcome tools reported in the literature. A total of 865 studies were screened following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and 124 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Each outcome tool was assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). Bias assessment was not deemed necessary for the purpose of this paper.


The Bone & Joint Journal
Vol. 102-B, Issue 5 | Pages 611 - 617
1 May 2020
Leo DG Jones H Murphy R Leong JW Gambling T Long AF Laine J Perry DC

Aims

To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children.

Methods

The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents.


Bone & Joint Open
Vol. 1, Issue 5 | Pages 121 - 130
13 May 2020
Crosby BT Behbahani A Olujohungbe O Cottam B Perry D

Objectives

This review aims to summarize the outcomes used to describe effectiveness of treatments for paediatric wrist fractures within existing literature.

Method

We searched the Cochrane Library, Scopus, and Ovid Medline for studies pertaining to paediatric wrist fractures. Three authors independently identified and reviewed eligible studies. This resulted in a list of outcome domains and outcomes measures used within clinical research. Outcomes were mapped onto domains defined by the COMET collaborative.


The Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 531 - 537
1 Apr 2017
Henderson ER Keeney BJ Pala E Funovics PT Eward WC Groundland JS Ehrlichman LK Puchner SSE Brigman BE Ready JE Temple HT Ruggieri P Windhager R Letson GD Hornicek FJ

Aims

Instability of the hip is the most common mode of failure after reconstruction with a proximal femoral arthroplasty (PFA) using an endoprosthesis after excision of a tumour. Small studies report improved stability with capsular repair of the hip and other techniques, but these have not been investigated in a large series of patients. The aim of this study was to evaluate variables associated with the patient and the operation that affect post-operative stability. We hypothesised an association between capsular repair and stability.

Patients and Methods

In a retrospective cohort study, we identified 527 adult patients who were treated with a PFA for tumours. Our data included demographics, the pathological diagnosis, the amount of resection of the abductor muscles, the techniques of reconstruction and the characteristics of the implant. We used regression analysis to compare patients with and without post-operative instability.


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1016 - 1023
1 Aug 2014
Haywood KL Griffin XL Achten J Costa ML

The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture.

We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required.

Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied.

Cite this article: Bone Joint J 2014; 96-B:1016–23.