Development of a core outcome set for lateral elbow tendinopathy (COS-LET) using best available evidence and an international consensus process.

OBJECTIVES: To develop a core outcome set for lateral elbow tendinopathy (COS-LET) and to provide guidance for outcome evaluation in future studies. METHODS: We implemented a multi-stage mixed-methods design combining two systematic reviews, domain mapping of outcome measurement instruments to the core domains of tendinopathy, psychometric analysis of instruments, two patient focus groups and a Delphi study incorporating two surveys and an international consensus meeting. Following the OMERACT guidelines, we used a 70% threshold for consensus. RESULTS: 38 clinicians/researchers and 9 patients participated. 60 instruments were assessed for inclusion. The only instrument that was recommended for the COS-LET was Patient Rated Tennis Elbow Evaluation (PRTEE) for the disability domain. Interim recommendations were made to use: the PRTEE function subscale for the function domain; PRTEE pain subscale items 1, 4 and 5 for the pain over a specified time domain; pain-free grip strength for the physical function capacity domain; a Numerical Rating Scale measuring pain on gripping for the pain on activity/loading domain; and time off work for the participation in life activities domain. No recommendations could be made for the quality-of-life, patient rating of condition and psychological factors domains. CONCLUSIONS: The COS-LET comprises the PRTEE for the disability domain. Interim-use recommendations included PRTEE subscales, time off work, pain-free grip strength and a Numerical Rating Scale measuring pain on gripping. Further work is required to validate these interim measures and develop suitable measures to capture the other domains.

Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET).

BACKGROUND: Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. METHODS: This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. CONCLUSIONS: There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. TRIAL REGISTRATION: Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497 .

Reliability analysis of radiologic and intraoperative loosening in total elbow arthroplasty.

BACKGROUND: Revisions of total elbow arthroplasties (TEAs) are commonly performed because of prosthetic loosening. UK National Joint Registry data show that TEA revisions are becoming increasingly common, with 123 TEA revisions performed in 2018 and 76 performed in 2017. TEA radiologic assessment is based on subjective interpretation with no published criteria. We defined TEA loosening by the presence of at least one of the following criteria: (1) progressive widening of the bone-cement, bone-prosthesis, or cement-prosthesis interface; (2) fragmentation or fracture of cement; (3) prosthetic component migration; and (4) bead shedding in porous-coated prostheses. Using this definition, we looked at interobserver and intraobserver agreement on radiologic loosening and compared this assessment with intraoperative findings. METHODS: In our tertiary care center, we conducted a retrospective review to identify TEA revisions performed between November 2008 and July 2018. Radiologic implant loosening was independently assessed by 5 orthopedic surgeons. Interobserver agreement (κ coefficient) was calculated. The majority's view of radiologic loosening was compared with intraoperative findings. RESULTS: We identified 93 sets of radiographs with implant stability clearly documented in their operative notes. The κ coefficient between assessors for humeral implant loosening was 0.87 (almost perfect). The κ coefficient for ulnar loosening was 0.75 (substantial). The κ coefficients for radiologic and intraoperative findings of humeral loosening and ulnar loosening were 0.67 and 0.71 (substantial), respectively. Intraobserver reliability was almost perfect for humeral loosening (κ = 0.86) and substantial for ulnar loosening (κ = 0.74). CONCLUSION: Our definition of loosening provides reproducible interobserver and intraobserver agreement on radiographic component loosening. In our center's experience, radiologic findings may not translate to intraoperative findings, and we would advise that surgical strategies for TEA revision include the possibility of needing to perform a dual-implant exchange.

Revision total elbow arthroplasty: Is it safe to perform a single-stage revision for presumed aseptic loosening based on clinical assessment, normal inflammatory markers, and a negative aspiration?

BACKGROUND: Revision total elbow arthroplasty (TEA) is a challenging procedure that is becoming increasingly common. In our unit, we regard it as essential to exclude infection as the underlying cause of TEA loosening. In all patients with arthroplasty loosening, we undertake a careful history and examination, perform radiographs, monitor inflammatory markers, and undertake a joint aspiration. If any investigation suggests infection as the etiology, then a 2-stage revision is undertaken. Open biopsies are not routinely performed. The aim was to ascertain from our outcomes whether it is safe to perform a single-stage revision for presumed aseptic loosening using these criteria. METHODS: A retrospective review of a consecutive series of revision TEAs was performed in our unit over a 10-year period (2008-2018). Single-stage revisions performed for presumed aseptic loosening were identified. Case notes, radiographs, bloods, aspiration results, and microbiology of tissue samples taken at revision were reviewed. RESULTS: A total of 123 revision elbow arthroplasty cases were performed in the study period. Sixty cases were revised for preoperatively proven infection, instability, or implant failure and were excluded from this study. In 63 cases, aseptic loosening was diagnosed based on history, clinical examination, blood markers, and aspiration. There were 21 dual-component and 42 single-component revisions. In the dual-component revision group, tissue samples taken at the time of revision were positive in only 1 case (5%). In the single-component revision group, positive culture samples were present in 3 cases (7%). χ2 analysis showed no significant difference between single- and dual-component revisions (P = .76). No cases with positive culture samples from either group have required subsequent revision surgery. CONCLUSION: Given the results of this study, we conclude that is safe to perform single-stage revision arthroplasty for implant loosening based on history, examination, normal inflammatory markers, and negative aspiration results without the need for open biopsy.

Antimicrobial stewardship in wound care.

Strategies to tackle the global crisis of antimicrobial resistance include implementing antimicrobial stewardship across the healthcare and agricultural sectors. Many clinical specialities have developed policies to advise practitioners on how to prescribe antibiotics more effectively, but there is still a lack of data on the impact of this change. Overuse and misuse of antibiotics have been commonplace since their introduction 70 years ago, and have contributed to the development of the resistance seen today. There is a dearth of new antibiotics and, if nothing is done to restrict the use of those that remain effective, there is a risk of returning to the pre-antibiotic era where simple infections could result in death. In wound care, it is essential that antibiotic treatment is appropriate to reduce infections. Many medical conditions predispose people to wounds that are difficult to heal and become chronic unless the underlying causes are addressed. Most wound infections are caused by bacteria, which are becoming increasingly resistant to commonly used antibiotics. This necessitates strict regimens for managing infection, which include prescribing antibiotics only when they are essential. Antimicrobial stewardship is undertaken in all UK healthcare facilities, and local advisory committees oversee the prudent use of antibiotics and other antimicrobial agents to try to prevent further increases in resistance. National guidance has been produced but whether full compliance has been followed has yet to be established and the impact of implementation needs to be analysed.

Antimicrobial assessment of a chitosan microfibre dressing: a natural antimicrobial.

OBJECTIVE: Chitosan is a natural biopolymer and is the main structural component of the cuticles of crustaceans, insects and molluscs and the cell walls of certain fungi. It is abundant in nature and is naturally antimicrobial. A natural fibre has been created with chitosan and is being used as a wound dressing, namely Kytocel. It is an absorbent fibre dressing that is claimed to be biodegradable and biocompatible. This study was undertaken to assess the antimicrobial properties of the microfibre wound dressing using a variety of methods commonly used to assess other antimicrobial dressings. METHOD: The zone of inhibition (ZOI) assay, challenge test (log reduction), time-to-kill and an in vitro wound model were all used in this report. Representative Gram-positive and Gram-negative bacteria were used and one yeast, Candida albicans. RESULTS: The ZoI test showed no observable zones around the dressing but killed the organisms underneath the dressing. There was a >3 log reduction of Staphylococcus aureus and Escherichia coli within two hours and >3 log reduction against Pseudomonas aeruginosa and Candida albicans between four and 24 hours in the challenge test. In the wound model, there was a 2 log reduction of Escherichia coli within the wound model and in the sponge and culture medium below the dressing. CONCLUSION: The chitosan microfibre wound dressing gives wound care an additional dressing to use to help prevent and manage bioburden and wound infection.

The Provision of Primary and Revision Elbow Replacement Surgery in the NHS.

BESS Surgical Procedure Guidelines (SPGs). Optimising Surgical Outcomes for Shoulder and Elbow patients. The British Elbow and Shoulder Society (BESS) SPGs are a series of evidence and consensus Best Practice Recommendations developed by BESS surgeons and physiotherapists to help drive quality improvement and achieve the best possible surgical outcomes for UK patients. This SPG on primary and revision elbow replacement surgery is supported and endorsed by both the British Orthopaedic Association (BOA) and the Getting It Right First Time (GIRFT) Programme.

Assessment of a personalized and distributed patient guidance system.

OBJECTIVES: The MobiGuide project aimed to establish a ubiquitous, user-friendly, patient-centered mobile decision-support system for patients and for their care providers, based on the continuous application of clinical guidelines and on semantically integrated electronic health records. Patients would be empowered by the system, which would enable them to lead their normal daily lives in their regular environment, while feeling safe, because their health state would be continuously monitored using mobile sensors and self-reporting of symptoms. When conditions occur that require medical attention, patients would be notified as to what they need to do, based on evidence-based guidelines, while their medical team would be informed appropriately, in parallel. We wanted to assess the system's feasibility and potential effects on patients and care providers in two different clinical domains. MATERIALS AND METHODS: We describe MobiGuide's architecture, which embodies these objectives. Our novel methodologies include a ubiquitous architecture, encompassing a knowledge elicitation process for parallel coordinated workflows for patients and care providers; the customization of computer-interpretable guidelines (CIGs) by secondary contexts affecting remote management and distributed decision-making; a mechanism for episodic, on demand projection of the relevant portions of CIGs from a centralized, backend decision-support system (DSS), to a local, mobile DSS, which continuously delivers the actual recommendations to the patient; shared decision-making that embodies patient preferences; semantic data integration; and patient and care provider notification services. MobiGuide has been implemented and assessed in a preliminary fashion in two domains: atrial fibrillation (AF), and gestational diabetes Mellitus (GDM). Ten AF patients used the AF MobiGuide system in Italy and 19 GDM patients used the GDM MobiGuide system in Spain. The evaluation of the MobiGuide system focused on patient and care providers' compliance to CIG recommendations and their satisfaction and quality of life. RESULTS: Our evaluation has demonstrated the system's capability for supporting distributed decision-making and its use by patients and clinicians. The results show that compliance of GDM patients to the most important monitoring targets - blood glucose levels (performance of four measurements a day: 0.87±0.11; measurement according to the recommended frequency of every day or twice a week: 0.99±0.03), ketonuria (0.98±0.03), and blood pressure (0.82±0.24) - was high in most GDM patients, while compliance of AF patients to the most important targets was quite high, considering the required ECG measurements (0.65±0.28) and blood-pressure measurements (0.75±1.33). This outcome was viewed by the clinicians as a major potential benefit of the system, and the patients have demonstrated that they are capable of self-monitoring - something that they had not experienced before. In addition, the system caused the clinicians managing the AF patients to change their diagnosis and subsequent treatment for two of the ten AF patients, and caused the clinicians managing the GDM patients to start insulin therapy earlier in two of the 19 patients, based on system's recommendations. Based on the end-of-study questionnaires, the sense of safety that the system has provided to the patients was its greatest asset. Analysis of the patients' quality of life (QoL) questionnaires for the AF patients was inconclusive, because while most patients reported an improvement in their quality of life in the EuroQoL questionnaire, most AF patients reported a deterioration in the AFEQT questionnaire. DISCUSSION: Feasibility and some of the potential benefits of an evidence-based distributed patient-guidance system were demonstrated in both clinical domains. The potential application of MobiGuide to other medical domains is supported by its standards-based patient health record with multiple electronic medical record linking capabilities, generic data insertion methods, generic medical knowledge representation and application methods, and the ability to communicate with a wide range of sensors. Future larger scale evaluations can assess the impact of such a system on clinical outcomes. CONCLUSION: MobiGuide's feasibility was demonstrated by a working prototype for the AF and GDM domains, which is usable by patients and clinicians, achieving high compliance to self-measurement recommendations, while enhancing the satisfaction of patients and care providers.

Conservative management of the post-traumatic stiff elbow: a physiotherapist's perspective.

Elbow stiffness is a common consequence following trauma with the management of this condition posing a challenge to therapists and surgeons alike. This paper discusses the role of conservative treatment, such as exercise and splinting, in the prevention and management of the stiff elbow, along with a review of available evidence, to justify their usage.

A framework for the comparison of mobile patient monitoring systems.

A mobile patient monitoring system makes use of mobile computing and wireless communication technologies for continuous or periodic measurement and analysis of biosignals of a mobile patient. In a number of trials these systems have demonstrated their user-friendliness, convenience and effectiveness for both patients and healthcare professionals. In this paper we propose a generic architecture, associated terminology and a classificatory framework for comparing mobile patient monitoring systems. We then apply this comparison framework to classify six mobile patient monitoring systems selected according to the following criteria: use of diverse mobile communication techniques, evidence of practical trials and availability of sufficient published scientific information. We also show how to use this framework to determine feature sets of prospective real-time mobile patient monitoring systems using the example of epilepsy monitoring. This paper is aimed at both healthcare professionals and computer professionals. For healthcare professionals, this paper provides a general understanding of technical aspects of the mobile patient monitoring systems and highlights a number of issues implied by the use of these systems. The proposed framework for comparing mobile patient monitoring systems can be used by healthcare professionals to determine feature sets of prospective mobile patient monitoring systems to address particular healthcare related needs. Computer professionals are expected to benefit by gaining an understanding of the latest developments in the important emerging application area of mobile patient monitoring systems.

Experience with Using the Sensewear BMS Sensor System in the Context of a Health and Wellbeing Application.

An assessment of a sensor designed for monitoring energy expenditure, activity, and sleep was conducted in the context of a research project which develops a weight management application. The overall goal of this project is to affect sustainable behavioural change with respect to diet and exercise in order to improve health and wellbeing. This paper reports results of a pretrial in which three volunteers wore the sensor for a total of 11 days. The aim was to gain experience with the sensor and determine if it would be suitable for incorporation into the ICT system developed by the project to be trialled later on a larger population. In this paper we focus mainly on activity monitoring and user experience. Data and results including visualizations and reports are presented and discussed. User experience proved positive in most respects. Exercise levels and sleep patterns correspond to user logs relating to exercise sessions and sleep patterns. Issues raised relate to accuracy, one source of possible interference, the desirability of enhancing the system with real-time data transmission, and analysis to enable real-time feedback. It is argued that automatic activity classification is needed to properly analyse and interpret physical activity data captured by accelerometry.

Investigation of food and environmental exposures relating to the epidemiology of Campylobacter coli in humans in Northwest England.

This study uses multilocus sequence typing (MLST) to investigate the epidemiology of Campylobacter coli in a continuous study of a population in Northwest England. All cases of Campylobacter identified in four Local Authorities (government administrative boundaries) between 2003 and 2006 were identified to species level and then typed, using MLST. Epidemiological information was collected for each of these cases, including food and recreational exposure variables, and the epidemiologies of C. jejuni and C. coli were compared using case-case methodology. Samples of surface water thought to represent possible points of exposure to the populations under study were also sampled, and campylobacters were typed with multilocus sequence typing. Patients with C. coli were more likely to be older and female than patients with C. jejuni. In logistic regression, C. coli infection was positively associated with patients eating undercooked eggs, eating out, and reporting problems with their water supply prior to illness. C. coli was less associated with consuming pork products. Most of the cases of C. coli yielded sequence types described elsewhere in both livestock and poultry, but several new sequence types were also identified in human cases and water samples. There was no overlap between types identified in humans and surface waters, and genetic analysis suggested three distinct clades but with several "intermediate" types from water that were convergent with the human clade. There is little evidence to suggest that epidemiological differences between human cases of C. coli and C. jejuni are a result of different food or behavioral exposures alone.

The role of Acticoat with nanocrystalline silver in the management of burns.

Silver is an effective antimicrobial agent, but older silver-containing formulations are rapidly inactivated by the wound environment, requiring frequent replenishment. These older formulations may also be pro-inflammatory and may delay healing. Acticoat (Smith & Nephew, Hull, UK) is a relatively new form of silver antimicrobial barrier dressing which helps avoid the problems of earlier agents. It has rapid and sustained bactericidal activity, and because of this may reduce inflammation and promote healing. Despite extensive testing and clinical experience, no evidence has emerged of resistance or cytotoxicity to nanocrystalline silver. This article collects together a number of presentations that were given at the 2003 European Burns Association Meeting on the use of Acticoat in the management of burns.

MobiHealth: ambulant patient monitoring over next generation public wireless networks.

The wide availability of high bandwidth public wireless networks as well as the miniaturisation of medical sensors and network access hardware allows the development of advanced ambulant patient monitoring systems. The MobiHealth project developed a complete system and service that allows the continuous monitoring of vital signals and their transmission to the health care institutes in real time using GPRS and UMTS networks. The MobiHealth system is based on the concept of a Body Area Network (BAN) allowing high personalization of the monitored signals and thus adaptation to different classes of patients. The system and service has been trialed in four European countries and for different patient cases. First results confirm the usefulness of the system and the advantages it offers to patients and medical personnel.

Mobile patient monitoring: the MobiHealth system.

The forthcoming wide availability of high bandwidth public wireless networks will give rise to new mobile health care services. Towards this direction the MobiHealth project has developed and trialed a highly customisable vital signals' monitoring system based on a Body Area Network (BAN) and an m-health service platform utilizing next generation public wireless networks. The developed system allows the incorporation of diverse medical sensors via wireless connections, and the live transmission of the measured vital signals over public wireless networks to healthcare providers. Nine trials with different health care cases and patient groups in four different European countries have been conducted to test and verify the system, the service and the network infrastructure for its suitability and the restrictions it imposes to mobile health care applications.