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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. Discussion. The proposed method to develop ICF Core Sets for OBPI yields a practical tool for multiple purposes: for clinicians to systematically assess and evaluate the individual’s functioning, for researchers to design and compare studies, and for patients to get more insight into their health problems and their management


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 259 - 260
1 Jul 2011
Daniels TR Pinsker E Inrig T Warmington K Beaton D
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Purpose: The objective of this study is to compare items from patient-reported questionnaires measuring musculoskeletal outcomes with items generated by pre-and post-operative ankle arthrodesis and arthroplasty patients using the Patient-Specific Index (PSI-P). The International Classification of Functioning, Disability and Health (ICF) was used as an external reference. Method: A literature review identified six questionnaires that assess lower extremity outcomes (AAOS, patient-reported portion of AOFAS, FFI, LEFS, SMFA, WOMAC). Surgical patients (n=142) from an orthopaedic surgeon’s practice completed the patient-selected items from PSI-P. Items from questionnaires and PSI-P were coded by three reviewers and linked to the ICF. The ICF is divided into four components (Body Functions and Structures, Activities and Participation, Environmental Factors, and Personal Factors) which are then further divided into second level categories. A higher number of second level categories would indicate a questionnaire that captures a broader range of experiences. Results: Patient’s responses from PSI-P identified 690 meaningful concepts that were linked to 45 second level ICF categories. Most PSI-P responses fell into Activities and Participation (60.6%) and Body Functions and Body Structures (35.2%) including the second level categories Walking (19.1%), Pain (16.5%), and Recreation and Leisure (15.4%). There was no statistical difference between arthrodesis and arthroplasty patients nor between pre-operative versus postoperative patients in terms of the proportion of patient responses that fell into each ICF component. A total of 237 meaningful concepts were identified in the 6 questionnaires studied and linked to 38 second level ICF categories. Overall, SMFA addressed the most number of second level categories and had the closest proportion of Body Function (23.0%) and Activities and Participation (68.9%) concepts as compared to PSI-P. The patient-reported portion of AOFAS addressed the fewest categories. LEFS only contained items from Activities and Participation. AAOS was the only questionnaire to address the issue of ‘swelling’, though it represented 4.9% of all PSI-P responses. Conclusion: Questionnaires differ largely in their content and no single questionnaire captured all of the concerns identified by PSI-P. This analysis will guide us in the development of a new and more comprehensive instrument for evaluating ankle outcomes following fusion or replacement


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 96 - 96
1 Mar 2017
Prudhon J Ferreira A Caton J Aslanian T Verdier R
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Introduction. Upper femoral fractures include intra and extra-capsular fracture (ECF). For intra-capsular fracture (ICF), hemi-arthroplasty (HA) is the most commonly used treatment. Interest in total hip arthroplasty (THA) is growing because THA yields less revision (4% versus 7%) associated to better functional results despite higher dislocation rate (9% versus 3%). Regarding ECF, internal fixation is the reference treatment. THA could represent a relevant alternative. This study evaluates the efficiency of THA using dual mobility cup (THA-DMC) as treatment of these fractures specially in elderly patients. Material and method. 70 patients were operated on for upper femoral fractures with Quattro THA-DMC between May 2012 and October 2013. Minimum follow-up is one year. Seven surgeons in 4 institutions were involved. Data collected were: age, gender, type of fracture, surgical approach, mortality, revision rate and dislocation rate. Results. Seventy patients were included. 83.3 % were women. Mean age was 82.8 (51–99). 43% were ECF and 57% ICF. Postero-lateral approach represented 51% of cases, trans-trochanteric 43% and Hardinge 6%. Mortality rate was 10%. One dislocation (1.4%) occurred at one month postoperative treated by closed reduction. No revision was performed. Discussion. Even though THA is widely used to treat ICF, two recent meta-analyses concluded that THAs bring better survivorship as well as better functional results despite a higher dislocation rates. THA-DMC is a way to decrease dislocation risk as confirmed by our study. There is a lack of studies published on the treatment of ECF, precluding a proper assessment. Conclusion. Given the studies identified, the gold standard in the treatment of ICF is moving toward THA. THA-DMC could overcome the higher dislocation rate observed with standard THA


Purpose: A systematic review of Health Related Quality of Life Outcomes(HRQOL) in metastatic disease of the spine and content validation of a new Spine Oncology Study Group Outcomes Questionnaire(SOSGOQ). To identify HRQOL questionnaires previously reported for spinal metastases and to validate the content of the new SOSGOQ based on the International Classification of Function and disability(ICF). Method: A systematic review identified 141 studies. Reported outcome tools were enumerated. The most commonly utilized (ESAS, Karnofsky Scale and ODI) and the SOSGOQ were linked to the ICF. Descriptive statistics examined the frequency and specificity of the ICF linkage. Linkage reliability was evaluated by inter-investigator percentage agreement. Results: The SOSGOQ contains 56 concepts, with all 4 domains of the ICF represented. 4 concepts could not be linked. There was 100% inter-observer agreement(IOA) for total number of concepts and for those ‘not covered’. 100% of concepts had ‘First and Second’ level linkage. 100% IOA exists at both ‘Component’ and “First Level’ linkage. There was 96.1% IOA at ‘Second’ Level. 33 concepts linked to Third Level with 96.9% IOA. 10 concepts linked at the Fourth Level with 100% IOA. Conclusion: The SOSGOQ includes all domains relevant for measurement of function and disability and it’s content validity is confirmed by linkage with the ICF. This new questionnaire has superior content capacity to measure disease burden of patients with metastatic disease of the spine than any instruments previously identified in the literature


Introduction. At Sheffield Children's Hospital, treatment of leg length discrepancy is a common procedure. Historically, this has been done with external fixators. With the development in intramedullary technology, internal nails have become the preferred modality for long bone lengthening in the adolescent population. However, it is important to review whether this technology practically reduces the known challenges seen and if it brings any new issues. Therefore, the aim of this review is to retrospectively evaluate the therapeutic challenges of 16 fit-bone intramedullary femoral lengthening's at Sheffield Children's Hospital between 2021–2022. Materials & Methods. The international classification of function (ICF) framework was used to differentiate outcomes. The patient's therapy notes were retrospectively reviewed for themes around structural, activity and participation limitation. The findings were grouped for analysis and the main themes presented. Results. There were 8 males, mean age 17.4 years (range 17–18) and 8 females, mean age 15.9 years (range 14–18). 5 right and 11 left femurs were lengthened. Underlying pathology varied amongst the 16 patients. All patients went into a hinged knee brace post operatively. Structural limitations included: pain, fixed flexion deformity of the knee, loss of knee flexion, quadriceps muscle lag, muscle spasms and gluteal weakness. The primary activity limitation was reduced weight bearing with altered gait pattern. Participation limitations included reduced school attendance and involvement in activities with peers. Access to Physiotherapy from local services varied dramatically. Five of the cohort have completed treatment. Conclusions. Anecdotally, intramedullary femoral lengthening nails have perceived benefits for families compared to external fixators in the adolescent population. However, there remain musculoskeletal and psychosocial outcomes requiring therapeutic management throughout the lengthening process and beyond. Therefore, quantifying these outcomes is essential for measuring the impact on each patient for comparison. To interpret these themes, we need to evaluate the outcomes objectively, this was not done consistently in this review. Future research should look at outcome measures that are sensitive to all aspects of the ICF. With an aim of improving the therapeutic treatment provided and the overall outcome for the children treated


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 385 - 386
1 Sep 2005
Bar-On E Mashiach R Ihbar O Weigl D Katz K Meizner I
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Purpose: To evaluate the predictive value of a prenatal ultrasound diagnosis of clubfoot, the ability to differentiate isolated clubfoot from complex clubfoot, and establish valid recommendations for follow-up and additional investigations. Materials and Methods: Clubfoot (CF) was diagnosed by prenatal ultrasound (US) in 85 feet in 48 fetuses at a mean gestational age of 21.6 weeks (14–35.6). All mothers were examined prenatally in a multidisciplinary clinic for fetal abnormalities. Postnatal outcome was obtained by chart review (24) or telephone interview (24) and feet were classified as Normal (N), Positional Deformity (PD), Isolated Clubfoot (ICF) and Complex Clubfoot (CCF). Results: At initial diagnosis, 65 feet in 38 fetuses were classified as ICF and 20 feet in 10 fetuses as CCF. Diagnosis was changed during follow-up US in 12 fetuses (25%) and final US diagnosis was N in one, ICF in 29 and CCF in 18 fetuses. Post natal clubfoot was found in 73 feet in 40 children giving a positive predictive value (PPV) of 85%. Accuracy of specific diagnosis was significantly lower – 65% initially and 75% at final US. No post natal CCF had been undiagnosed and inaccuracies were all overdiagnoses. 24 kariotypes were performed. Three were abnormal but had additional US findings and had been classified as CCF. No abnormal kariotypes were found in fetuses diagnosed as ICF. Conclusions:. The prenatal diagnosis of clubfoot carries a positive predictive value of 87% with lower values of ICF (76%) and CCF (69%). The diagnostic accuracy increases with follow up ultrasound examinations which should be performed periodically. The most problematic diagnosis to rule out is arthrogryposis and further diagnostic modalities should be researched. When Isolated Clubfoot is diagnosed, the indication for amniocentesis and kariotyping is questionable


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 130 - 130
1 May 2012
E. P T. D T. I K. W D. B
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Purpose. The objective of this study was to compare items from musculoskeletal outcome questionnaires with items generated by pre- and post-operative ankle arthrodesis and arthroplasty patients (patient-selected portion of the Patient-Specific Index (PASI-P)) to determine if existing questionnaires address patients' concerns. Materials/Methods. Patients (n=142) completed the PASI-P. Items from 6 standardised questionnaires (AAOS, patient-reported portion of AOFAS, FFI, LEFS, SMFA, WOMAC) and PASI-P were matched by 3 reviewers to corresponding categories in the International Classification of Functioning, Disability and Health (ICF). The ICF classification hierarchy codes broad first categories and increasingly detailed second, third, and fourth categories. The standardised questionnaires were then compared to the ‘gold standard’ of PASI-P. Results. 690 concepts were identified in the patients' responses, which corresponded to 45 ICF categories. Most PASI-P concepts fell into Activities and Participation (60.3%) and Body Functions and Body Structures (35.2%), including the second level categories ‘walking’ (21.6%), ‘pain’ (18.7%), and ‘recreation and leisure’ (17.4%). A total of 237 concepts was identified in the 6 questionnaires and linked to 39 second level ICF categories. Overall, SMFA addressed the most second level categories and had the closest proportion of Activities and Participation (68.9%) and Body Functions (23.0%) concepts compared to the patient-generated responses. The patient-reported portion of AOFAS addressed the fewest categories. LEFS only contained items from Activities and Participation. AAOS was the only questionnaire to address the issue of ‘swelling’, though it represented 5.6% of all patient-generated responses. The concepts of ‘swelling’, ‘recreation and leisure’, and ‘sports’ were seldom included in the questionnaires. Conclusion. No single questionnaire captured all concerns identified by patients, and the standardised questionnaires differed largely in content. Clinicians should recognise patient concerns relevant to the ankle currently not included in available questionnaires. This analysis will guide the development of a more comprehensive instrument for evaluating ankle outcomes


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 105 - 105
1 Sep 2012
Chahal J Whelan DB Jaglal S Smith P MacDonald PB Toor GS Davis AE
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Purpose. No knee-specific outcome measures have demonstrated reliability, validity or responsiveness in patients with multiligament knee injuries. Furthermore, the content validity of existing questionnaires has been challenged and remains unknown for patients with concomitant neurovascular injury. As a first step in developing a disease-specific outcome measure, the objective of this study was to identify items from existing knee questionnaires pertinent to patients with multiligament knee injuries using established a priori criteria. Method. Eighty-five consecutive patients from a level one trauma centre were mailed a questionnaire comprising 124 items from 11 knee-specific instruments. They rated the frequency and importance for each item on a five-point Likert scale. Criteria for item selection included a mean importance rating (MIR) ≥ 3.5 and frequency < 30% for the response never experienced. The World Health Organization International Classification of Functioning, Disability and Health (ICF) framework was used to support the content. Results. The average age of the 60/85 respondents (70.6%) was 34.7 years and most were male (n=45). Average time from injury was 845 days. Using the Schenck classification, 19 patients were KD I, two were KD II, 39 were KD IIIL or IIIM, and nine were KD IV. Nineteen had peroneal nerve injury and five had a vascular injury. Forty-four patients were treated surgically, six nonoperatively and 10 are pre-operative. Sixty-one of 124 questionnaire items met the a priori inclusion criteria. Based on the ICF, 22 of the retained items were physical impairments (PI), 15 items were emotional impairments (EI), 18 items were activity limitations (AL), and six items were participation restrictions (PR). The 10 items with the highest MIR included six EI, one PI and three PR. Twenty-four items (PI=6 EI=13, AL=2, PR=3) of the Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QoL) satisfied the a priori criteria and this instrument also endorsed the most items within the EI and PR constructs. The Knee Osteoarthritis and Injury Outcome Score (KOOS) had 21 items (PI=7, EI=2, AL=11, PR=1) which satisfied the a priori criteria and also had the most items within the PI and AL constructs. The International Knee Documentation Committee (IKDC) Subjective Knee Form had 12 items (EI=0, PI=3, AL=9, PR=0) meeting criteria while the remaining questionnaires contained 11 items with concepts redundant to above. Combining the ACL-QoL and KOOS resulted in representation of 41/61 of the retained items (PI=13, EI=13, AL=12, PR=3). No existing instrument includes content that may result from neurological or vascular injury. Conclusion. This work has identified over sixty pertinent items across the various ICF domains relevant to patients with multiligament knee injuries. The ACL-QoL and KOOS together address over two thirds of these items. Patient and clinician focus groups will be conducted to address missing content and to further refine the questionnaire items


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. 5, Issue 6 | Pages 499 - 513
20 Jun 2024
Keene DJ Achten J Forde C Png ME Grant R Draper K Appelbe D Tutton E Peckham N Dutton SJ Lamb SE Costa ML

Aims

Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Methods

This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.


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.


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.


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. 91-B, Issue SUPP_II | Pages 279 - 279
1 May 2009
Björklund M Hamberg J Heiden M Barnekow-Bergkvist M
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Background: Disability questionnaires for LBP-patients mostly emanate from health professionals and have a content of different domains of disability presented as a single sum score, making it difficult to derive changes within a specific domain. This study introduces a new back-specific questionnaire, the Profile Fitness Mapping questionnaire (PFM), which was based on patient’s self-reported characteristics of the LBP. The PFM incorporates both a functional limitation and a symptom scale, with further subdivision of the symptom scale in separate indices for severity and temporal aspects. The aim of the study was to assess the overall validity of the PFM. Methods and Results: Chronic LBP-patients (n=193) answered the PFM and four validated back-specific criterion questionnaires. The correlation coefficients between the PFM and the criterion questionnaires showed good concurrent criterion validity (0.61 – 0.83). The best discriminative ability between patients with different pain severity was demonstrated by the functional limitation scale of the PFM. Classification according to the ICF revealed a high degree of homogeneous item content of the symptom scale to the domain of impairments, and of the functional limitation scale to the domain of activity limitations. Well centered score distribution indicates that the PFM has the potential to detect improvement or worsening of symptoms and functional limitations in chronic LBP-patients. Conclusion: The results of the study signify that the PFM is a valid indicator of symptoms and functional limitations of LBP-patients. It provides the combination of a composite total score and the possibility of evaluations within specific domains of disability


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 206 - 206
1 May 2006
Angst F Goldhahn J
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Background Critical reflection in clinical routine and research raises the question of how we measure outcome. The classical etiopathogenetic way of thinking has led to biophysical, investigator-based, ‘objective’ parameters. However, new concepts of holistic health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) emphasize the patient’s (subjective) perception. Methods We present different approaches to health and health-related quality of life assessment by applying assessment tools to specific examples and providing an overview of some of the existing instruments with an analysis of their properties. Results Self-assessments reflect the patient’s needs more closely than biophysical parameters. Reliability and validity of the self-assessments are high and population surveys provide valid norms for comparisons. Generic instruments offer a comprehensive range of measurements, and condition-specific self-assessment tools differ in their pattern of health dimensions and their sensitivity to change (responsiveness) as expressed by specific scales. A specific set of instruments has to be compiled appropriate to the focus of interest. Conclusions Self-assessments are an important complement to clinical signs as indicators of the patient’s condition and fulfill the requirements of the modern salutogenetic, holistic view of the patient as set out in the ICF concept. As a valid representation of the patient’s needs they help in the optimization of disease management and medical-economic planning


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 592 - 592
1 Nov 2011
Hoang-Kim M Bhandari M Beaton DE Schemitsch EH
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Purpose: Today, numerous functional outcome tools exist to assess the patient’s ability to carry out basic and instrumental activities of daily living. Furthermore, the increase in range of mobility measures reflect differences in rating scales, scores, administration and scoring options which make outcome results difficult to assess across trials. Because of the lack of consensus among investigators, we wanted to identify the citation patterns of the functional outcomes tools used by investigators in hip fracture RCTs. We believed that the lack of proper citation is an underlying factor in the diverse usage of outcome tools. Method: We extracted the citations of disability tools from 59 Level 1 hip fracture RCTs. Disability was defined using the WHO classification (ICF). We excluded measures assessing body structure. The text and reference lists of the identified articles were screened in order to compile relevant literature on the instrument used in the RCT. Disability tools which were cited in the references were also compared to original development articles. Results: Overall 68 different instruments were identified that measured disability in the hip fracture literature. According to ICF, 47 tools measured body function alone, 13 tools evaluated activity limitations and participation restriction and 8 were composite scoring systems. We found that 34.2% of the trials did not provide any citations to the tools assessing body function. In trials measuring activity and participation, 23.2% provided instrument citations. In trials using composite scoring systems, 19.4% of the trials provided instrument citations. All of the instrument citations when provided by the investigators were found to correspond to original development articles or trials. Conclusion: The appropriate choice of a functional outcome instrument is fundamental in order to ensure that the results that are obtained reflect the patient. However, if citations of the indices and scales themselves are lacking, trial methodology and results could be informative but not replicated. In the future, we recommend that rigor in quality reporting include proper instrument citations


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.