Introduction: Randomised Controlled Trials (RCTs) of interventions to reduce the incidence of falls have used a variety of methods to define and measure outcomes. A standardised approach to defining and measuring outcomes, and a shared taxonomy of interventions is a prerequisite to interpret and disseminate the findings of studies. Method: We agreed to focus on five areas: falls, injuries, psychological consequences, physical activity and quality of life. A systematic literature review has been performed to identify outcome definitions currently used in RCTs and is focusing on the quality of outcome measures in terms of reliability, validity and acceptability. A consensus building process is being performed using a modified nominal group technique to define a core set of outcome definitions and measures, which can then be piloted in a number of sites across Europe. Where consensus cannot be achieved, suggestions are made for future research to develop and/or appraise new methods of measurement and these will feed into future revisions of the recommendations. The taxonomy of interventions is being developed in parallel with this process. Results: The presentation will demonstrate how varying methods of defining falls can lead to a different interpretation of trial results and suggest a range of definitions than might be included in future trials. We consider the number of falls, number of fallers, time to first fall, and fractures per fall ratios as examples. Conclusions: An agreed and standardised set of outcome definitions and measures is important to improve the robustness of data from intervention studies, will enable comparison across studies, good quality measurement in multi-centre trials, and facilitate meta-analysis of trial results. A taxonomy of interventions facilitates comparisons between studies, helps to determine the most effective components or sub-components of interventions, and aids the decision making process of policy makers and health insurance plans

Aims. Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Methods. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy. Results. A total of 532 eligible studies were identified, reporting 1,803 outcomes with 786 unique outcome terms, which collapsed to 82 standardized outcome headings. Overall 479 individual outcome measurement instruments were identified, including 298 outcome definitions, 27 patient- and 18 clinician-reported outcome measures, and six physical performance measures. The most-reported outcome was ‘bone union/healing’ reported in over 50% of included studies, while health-related quality of life was only measured in 6% of included studies. Conclusion. Outcomes reported for people recovering from open lower limb fracture are heterogeneous, liable to outcome reporting bias, and vary widely in the definitions and the measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical functioning, have been neglected. This systematic review identifies the need to unify outcome measures reported on patients recovering from open lower limb fracture; this may be addressed by creating a core outcome set. Cite this article: Bone Joint Res 2023;12(2):138–146

Aims. Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. Methods. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy. Results. A total of 3,303 records were screened, of which 99 studies were included. Most studies were case series (77/99; 78%) and assessed one method of reconstruction (68/99; 69%). A total of 511 outcomes were reported, which were grouped into 58 distinct outcomes. Overall, 143/511 of all outcomes (28%) were provided with a clear, in-text definition, and 231 outcomes (45%) had details reported of how and when they were measured. The most commonly reported outcome was ‘recurrence of osteomyelitis’ (62; 12%). The single-most patient-reported outcome measure was ‘pain’. Conclusion. This study has highlighted significant inconsistencies in the defining, reporting, and measuring of outcomes across studies investigating surgical management for chronic osteomyelitis of the lower limb in adults. Future studies should clearly report complete details of how outcomes are defined and measured, including timing. The development of a standardized core outcome set would be of significant benefit in order to allow evidence synthesis and comparison across studies. Cite this article: Bone Jt Open 2023;4(3):146–157

Objectives. Prosthetic joint infection (PJI) is the most common cause of arthroplasty failure. However, infection is often difficult to detect by conventional bacterial cultures, for which false-negative rates are 23% to 35%. In contrast, 16S rRNA metagenomics has been shown to quantitatively detect unculturable, unsuspected, and unviable pathogens. In this study, we investigated the use of 16S rRNA metagenomics for detection of bacterial pathogens in synovial fluid (SF) from patients with hip or knee PJI. Methods. We analyzed the bacterial composition of 22 SF samples collected from 11 patients with PJIs (first- and second-stage surgery). The V3 and V4 region of bacteria was assessed by comparing the taxonomic distribution of the 16S rDNA amplicons with microbiome sequencing analysis. We also compared the results of bacterial detection from different methods including 16S metagenomics, traditional cultures, and targeted Sanger sequencing. Results. Polymicrobial infections were not only detected, but also characterized at different timepoints corresponding to first- and second-stage exchange arthroplasty. Similar taxonomic distributions were obtained by matching sequence data against SILVA, Greengenes, and The National Center for Biotechnology Information (NCBI). All bacteria isolated from the traditional culture could be further identified by 16S metagenomics and targeted Sanger sequencing. Conclusion. The data highlight 16S rRNA metagenomics as a suitable and promising method to detect and identify infecting bacteria, most of which may be uncultivable. Importantly, the method dramatically reduces turnaround time to two days rather than approximately one week for conventional cultures. Cite this article: M-F. Chen, C-H. Chang, C. Chiang-Ni, P-H. Hsieh, H-N. Shih, S. W. N. Ueng, Y. Chang. Rapid analysis of bacterial composition in prosthetic joint infection by 16S rRNA metagenomic sequencing. Bone Joint Res 2019;8:367–377. DOI: 10.1302/2046-3758.88.BJR-2019-0003.R2

Introduction. The heterogeneity of outcomes used in the field of lower limb lengthening surgery (LLLS) affects our ability to synthesize evidence. This hampers robust systematic reviews and treatment recommendations for clinical practice. Ultimately this reduces the impact of research for both patients and healthcare professionals. This scoping review aimed to describe the outcomes and outcome measurement instruments (OMIs) used within the field of LLLS. Method. A systematic literature search of WOS, Scopus, Embase, MEDLINE, and the Cochrane Library identified all studies reporting outcomes in children and adults after LLLS. All outcomes and OMIs were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using the COMET Taxonomy of Outcomes. Result. Data saturation was achieved in 2020. A total of 142 studies were included between 2024-2020, reporting 2964 verbatim outcomes with 663 standardized outcome terms collapsed into 119 outcome headings (subdomains). A total of 29 patient-reported and 26 clinician-reported outcome instruments were identified. The most commonly reported outcome was “Lengthening amount”, reported in over 72% of the included studies, while “health-related quality of life” was measured in 16% and all life impact outcomes were reported in 19% of the included studies. Conclusion. A large number of peer-reviewed publications are available, demonstrating that significant resources are being devoted to research on LLLS. However, reported outcomes for people with LLLS are heterogeneous, subject to reporting bias, and vary widely in the definitions and measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical function, have been neglected. This scoping review identifies a need to standardize outcomes and outcome measures reported on patients recovering from lower limb lengthening surgery; this can be addressed by creating a core set of outcomes

Aim. While metagenomic (microbial DNA) sequencing technologies can detect the presence of microbes in a clinical sample, it is unknown whether this signal represents dead or live organisms. Metatranscriptomics (sequencing of RNA) offers the potential to detect transcriptionally “active” organisms within a microbial community, and map expressed genes to functional pathways of interest (e.g. antibiotic resistance). We used this approach to evaluate the utility of metatrancriptomics to diagnose PJI and predict antibiotic resistance. Method. In this prospective study, samples were collected from 20 patients undergoing revision TJA (10 aseptic and 10 infected) and 10 primary TJA. Synovial fluid and peripheral blood samples were obtained at the time of surgery, as well as negative field controls (skin swabs, air swabs, sterile water). All samples were shipped to the laboratory for metatranscriptomic analysis. Following microbial RNA extraction and host analyte subtraction, metatranscriptomic sequencing was performed. Bioinformatic analyses were implemented prior to mapping against curated microbial sequence databases– to generate taxonomic expression profiles. Principle Coordinates Analysis (PCoA) and Partial Least Squares-Discriminant Analysis were utilized to ordinate metatranscriptomic profiles, using the 2018 definition of PJI as the gold-standard. Results. After RNA metatranscriptomic analysis, blinded PCoA modeling revealed accurate and distinct clustering of samples into 3 separate cohorts (infected, aseptic, and primary joints) – based on their active transcriptomic profile, both in synovial fluid and blood (synovial anosim p=0.001; blood anosim p=0.034). Differential metatranscriptomic signatures for infected versus noninfected cohorts enabled us to train machine learning algorithms to 84.9% predictive accuracy for infection. Multiple antibiotic resistance genes were expressed, with high concordance to conventional antibiotic sensitivity data. Conclusions. Our findings highlight the potential of metatranscriptomics for infection diagnosis. To our knowledge, this is the first report of RNA sequencing in the orthopaedic literature. Further work in larger patient cohorts will better inform deep learning approaches to improve accuracy, predictive power, and clinical utility of this technology

Aim. Bone and joint infections (BJI) need frequently prolonged antibiotic treatment at high dosage for a total of 6 or 12 weeks depending the type of infection. Impact of such prolonged antibiotic exposure on the gut microbiota has never been assessed. Method. We performed a national multicentric prospective study of patients with BJI to monitor the gut microbiota dynamic all along antimicrobial treatment. Clinical data and stool collection were performed at the baseline visit (B) within 24h before starting antibiotics, at the end of the treatment (EOT) and 2 weeks after antibiotic withdrawal during a follow-up visit (FU). Microbiota composition was determined by shotgun metagenomic sequencing. Biological markers of gut permeability and inflammation were monitored at each time point. Results. Sixty-two patients were enrolled: 27 native BJI, 14 osteosynthesis-related BJI and 21 prosthetic joint infections (PJI). At EOT there was a significant loss of alpha-diversity that recovered at FU in patients with native BJI and PJI but not in patients with osteosynthesis-related BJI (p<0.05, Wilcoxon test). At EOT, we observed an increase of Proteobacteria and Bacteroidetes that partially recovered at FU. Principal Component Analysis (PCoA) of the Bray Curtis distance, showed a significant change of the gut microbiota at the end of treatment compared to baseline (p<0.01, PERMANOVA) that only partially recover at FU. The taxonomic analysis showed that microbiota composition at FU does not differ significantly at the genus level when comparing patients treated for 6 weeks to patients treated for 12 weeks. No particular antibiotic (especially fluoroquinolones) was associated with a lower Shannon index or distinct dynamic of recovery at the end of treatment. PCoA analysis of the Bray Curtis distance shows that patients with elevated plasma level of CRP (≥5mg/L) at EOT had a distinct gut microbial composition compared to others. Conclusions. In patients with BJI, antibiotics altered the gut microbiota diversity and composition with only partial recovery 2 weeks after antibiotic withdrawal, independently on the duration of the therapy and on the type of the antibiotic used. Elevated CRP at EOT might reflect persistent alteration of the gut microbiota. Assessment of long-term impact after the end of treatment is on-going

Background. Medical Research Council (MRC) guidelines recommend applying theory within interventions to explain how behaviour change occurs. Guidelines endorse self-management of chronic low back pain (CLBP) and osteoarthritis (OA), but evidence for its effectiveness is weak. This literature review aimed to determine the use of behaviour change theory and techniques within group-based self-management randomised controlled trials for chronic musculoskeletal pain, including CLBP and OA. Methods. A two phase search strategy of electronic databases was used to identify systematic reviews and studies relevant to this area. Articles were coded independently for their use of behaviour change theory, and the number of behaviour change techniques (BCTs) was identified using a 93 item taxonomy, Taxonomy (v1). Results. 25 articles of 22 studies met the inclusion criteria, of which only three reported having based their intervention on theory, and all used Social Cognitive Theory. A total of 29 BCTs were coded across all articles with the most commonly identified techniques being ‘instruction on how to perform the behaviour’, ‘demonstration of the behaviour’, ‘behavioural practice’, ‘credible source’, ‘graded tasks’ and ‘body changes’. Conclusion. The findings demonstrate that theoretically driven research within self- management for chronic musculoskeletal pain is lacking, or is poorly reported and may partly explain the weak evidence surrounding its effectiveness, Future research that follows MRC and CONSORT guidelines regarding the use of theory and the importance of its reporting is warranted. Programmes should be theoretically based, and focus on comprehensive reporting of all trial aspects, including the basis of technique and theory selection. Conflicts of interest: No conflicts of interest. Sources of funding: This review was conducted as part of Health Research Award HRA_HSR/2012/24 from the Health Research Board of Ireland

ProFaNE, Prevention of Falls Network Europe, is a four year project, funded by the European Community Framework 5. It is a thematic network, coordinated by the University of Manchester, UK, with 25 partners across Europe. There are also Network Associates from a number of EU and non-EU countries who give their advice and experience at meetings, seminarsand conferences. The aim is to bring together workers from around Europe to focus on a series of tasks aimed at developing multi-factorial prevention programmes to reduce the incidence of falls and fractures amongst elderly people. The work of ProFaNE is practical, both in terms of developing the evidence base for implementation of effective interventions and encouraging best practice across Europe. The task of each work package is to convene workshops, undertake personnel exchanges and set up collaborative studies, data sharing in order to develop evidence based protocols and publications which can be used to implement change. Work Package 1 - Fall prevention trials - Taxonomy of interventions and agreed set of outcomes. An agreed and standardised set of outcome definitions and measures is important to improve the robustness of data from intervention studies, will enable comparison across studies, good quality measurement in multi-centre trials, and facilitate meta-analysis of trial results. A taxonomy of interventions will facilitate comparisons between studies, help to determine the most effective components or sub-components of interventions, and aid the decision making process of policy makers and health insurance plans. A Consensus taxonomy and outcome measures statement, Trial design statement, Meta - analysis protocol and Self help materials will be produced. Work Package 2 - Clinical Assessment and Outcomes. Aims to gain an understanding of the current issues surrounding falls prevention across Europe and to embrace at national and international level, the different political and health service agendas in each country such that recommendations can ultimately be translated into working models of practice. They will establish a robust network of key members across Europe to facilitate the effective and efficient promulgation of evidence likely to influence service developments at national and local level and derive a consensus approach to assessment and management of older people at risk of falling in a variety of clinical settings using the existing evidence base as well as inviting expert opinions in the field. Work Package 3 - Assessment of balance function and prediction of falls. Measurement tools are needed that predict the risk of falling and give objective assessment of balance function needed for daily life performance. The ultimate goal of the activities within this work package is to combine the expertise of different disciplines for the development of balance assessment tools that meet the requirements for large-scale intervention studies and routine-use in clinical settings. The knowledge needed to develop these instruments and measures is scattered over a wide range of disciplines (ranging from physiology to electrical engineering). Work Package 4 - Psychological aspects of falling. We need to understand the psychosocial factors which affect the benefit of falling prevention programmes for older people. These include attitudes to falling (such as fear) and factors that promote or reduce uptake of and adherence to a range of falling-related interventions, including exercise. Understanding of attitudes and behaviour will inform guidelines for the design of interventions, and development of measures to assess relevant attitudes. We also co-ordinate development of self-test indices that older people can use to evaluate their own risk of falling, together with guidance as to the actions they should take to prevent falling

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.

Aim. Culture of multiple periprosthetic tissue samples is the current gold-standard for microbiological diagnosis of prosthetic joint infections (PJI). Additional diagnostic information may be obtained through sonication fluid culture of explants. These current techniques can have relatively low sensitivity, with prior antimicrobial therapy or infection by fastidious organisms particularly influencing culture results. Metagenomic sequencing has demonstrated potential as a tool for diagnosis of bacterial, viral and parasitic infections directly from clinical samples, without the need for an initial culture step. We assessed whether metagenomic sequencing of DNA extracts from sonication fluid can provide a sensitive tool for diagnosis of PJI compared to sonication fluid culture. Method. We compared metagenomic sequencing with standard aerobic and anaerobic culture in 97 sonication fluid samples from prosthetic joint and other orthopaedic device-related infections. Sonication fluids were filtered to remove whole human cells and tissue debris, then bacterial cells were mechanically lysed before DNA extraction. DNA was sequenced and sequencing reads were taxonomically classified using Kraken. Using 50 derivation samples, we determined optimal thresholds for the number and proportion of bacterial reads required to identify an infection and confirmed our findings in 47 independent validation samples. Results. A total of 131 sonication fluids were aerobically and anaerobically cultured and underwent metagenomic sequencing. From the first 72 sonication fluid samples sequenced 22 samples from six batches were excluded, as these samples and negative controls from the same batches showed similar contamination. The remaining 50 samples, the derivation set, were used to determine optimal sequence thresholds for identifying true infection. Of 59 subsequently sequenced validation samples, 12 from a single batch were excluded as the negative control was contaminated with Propionibacterium acnes, leaving 47 validation samples. Compared to sonication fluid culture, the species-level sensitivity of metagenomic sequencing was 61/69(88%,95%CI 77–94%)(derivation samples 35/38[92%,79–98%]; validation samples 26/31[84%,66–95%]), and genus-level sensitivity was 64/69(93%,84–98%). Species-level specificity, adjusting for plausible fastidious causes of infection, species found in concurrently obtained tissue samples, and prior antibiotics, was 85/97(88%,79–93%)(derivation 43/50[86%,73–94%], validation 42/47[89%,77–96%]). High levels of human DNA contamination were seen despite use of laboratory methods to remove it. Conclusions. We demonstrate as a proof of principle that metagenomic sequencing can provide accurate diagnostic information in PJI. Further depletion of human DNA will lead to improved genomic information on the cause of infection, strengthening the case for metagenomic sequencing as a diagnostic tool in PJI

Aims

Post-traumatic osteoarthritis (PTOA) is a subset of osteoarthritis (OA). The gut microbiome is shown to be involved in OA. However, the effect of exercise on gut microbiome in PTOA remains elusive.

The need for a better understanding of factors that influence surgical outcome has grown as many complications are thought to be avoidable. One approach proven useful in studying surgical procedures is time-action analysis (TAA), a method which objectively determines the efficiency of individual steps. The aim of this study was to assess the surgical process of total knee arthroplasty using TAA, thus enhancing the insight into the procedure, influence of team members and adverse events, eventually leading to process improvement and reduction of error probability. Methods: In two high output centres and one teaching hospital 37 TKA surgeries were recorded, using 3 different knee systems (NexGen, LCS and Triathlon). The process was analyzed using a fixed taxonomy and the duration, limitations and repetitions were determined using video analysis software. The efficiency of the surgeon was calculated by dividing the time the surgeon spends operating by the time operating plus the time spent talking, thinking or repeating. Results: Although the two high output centres used different knee systems there was no difference in operating time (47min. (95%CI, 43.2 to 50.1) versus 47min. (42.1 to 51.9)). With an inexperienced nurse the waiting time increased in both hospitals during the femoral osteotomy phase (p= 0.01 and p=0.05). Comparing to a training hospital, the tibial alignment phase showed lower surgical efficiency for both the consultant and 6th year residents (80% vs. 95%, p=0.01). Also the nurse waiting time increased during all phases (18min. vs. 2min., p=0.00). In the teaching hospital more problems (communication, instrument and skill) occurred (mean 19 vs. 5 and 2, p=0.00) and twice as much communication problems existed with residents regardless of nurse experience. Surprisingly the number of problems handling instruments increased inversely with nurse experience (p=0.02) as did the waiting time (27min. vs. 15min.) again being highest in the femoral osteotomy phase (p=0.00). Conclusion: The similar results in the high output centres show that TKA is a similar and structured process regardless of the knee system, its efficiency mainly dependent on surgical output. The decrease in resident efficiency is caused by less structured use of instruments and miscommunication with the nurse. For nurses the femoral osteotomy phase is most difficult, requiring high attention due to frequent changing of different pins and cutting blocks. Unfamiliarity with instruments (i.e. low volume) results in higher waiting times. Regardless of the knee system the steps of TKA are similar, therefore a consistent surgeon-nurse (OR tech) verbal interaction is advocated especially with a less experienced team. Training should focus knowledge of instruments using uniform names. Extra attention should be paid by those who do not often place knees to communication with the nurse and clear order of the procedure

Objectives:. To gain an understanding of the current issues surrounding falls prevention across Europe and to embrace at national and international level, the different political and health service agendas in each country such that recommendations can ultimately be translated into working models of practice in each country. To establish a robust network of key members across Europe to facilitate the effective and efficient promulgation of evidence likely to influence service developments at national and local level. To derive a consensus approach to assessment and management of older people at risk of falling in a variety of clinical settings using the existing evidence base as well as experts in the field. To ultimately facilitate a pan-European approach to assessment and management of falls whilst minimising impact on clinical autonomy and paving the way for further research activity within member states. Description of work: This work package focuses on the development of a consensus approach to the assessment and management of falls in older people across Europe. Fundamental to this process is the development of a clear understanding of how services across Europe are currently configured and what the national and international drivers for change might be over the next 5–10yrs. The ultimate aim is to be able to facilitate the development of a set of comparable assessment and outcome measures to be used in a large randomised controlled trial with fracture as the primary outcome measure. Year 1. Whilst undertaking the networking exercise in year 1, members had the opportunity to visit key individuals in European countries and anticipate the potential opportunities and constraints of developing and delivering falls services in a co-ordinated and comprehensive fashion. Year 2 focuses on the development of assessment tools, which can be tailored so as to be applied in a variety of clinical settings from community based assessment to the highly specialised investigation units. The work package links closely with other work packages on balance and gait and psychology to ensure consensus in recommendations. In addition to the recommendations for clinical assessment and management, the work package also provides advice and guidance on evaluation and audit of services and as such links closely with the taxonomy work. Recommendations are to be peer reviewed. Year 3 entails the collation of agreed assessment and evaluation methods and the translation of the recommendations into a format for dissemination including written documentation translated into a number of different languages and an interactive website with links to relevant organisation across Europe and the rest of the world. Year 4. During the final year, members of the work package take responsibility for the dissemination of the work to clinical colleagues

Aims

The effect of the gut microbiota (GM) and its metabolite on bone health is termed the gut-bone axis. Multiple studies have elucidated the mechanisms but findings vary greatly. A systematic review was performed to analyze current animal models and explore the effect of GM on bone.

Objectives

Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property.

Objectives

The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF).