Objectives To validate reliability of slice-encoding for metal artifact correction (SEMAC) sequences in identifying prosthesis loosening in patients with painful knee arthroplasties (KAs) by comparing SEMAC-magnetic resonance imaging (MRI) findings to surgical outcomes-the gold standard. Materials and Methods We prospectively followed 44 painful KA patients with possible aseptic prosthesis loosening at our tertiary care institution from 2011 to 2017. Potential cases of infective loosening were excluded making ours a selective study population. We acquired conventional and SEMAC-MRI images for all patients on 1.5-T MRI scanner. Two consultants scored MRI findings for complications such as osteolysis and bone marrow edema systematically. Scoring variations were settled by consensus. We used the Mann-Whitney U test and Wilcoxon signed-rank test for quantitative analysis and Spearman's rank-order correlation for correlation analysis of SEMAC findings and surgical outcomes, and followed the Outcome Measurements in Rheumatology filter methodology to assess the ability of SEMAC-MRI to detect prosthetic loosening. Results Eleven patients needed revision surgery-seven had prosthesis loosening and four had retained native compartment osteoarthritis. Thirty-three were treated conservatively, of which 17 had spontaneous pain resolution and 8 had extra-articular causes-referred pain from hip (1 patient) and lumbar (7 patients) degeneration. Eight patients had adequate pain control without prosthesis loosening on follow-up. T1W-SEMAC identified surgically proven prosthesis loosening in all cases and short tau inversion recovery (STIR)-SEMAC diagnosed bone marrow edema (BME) in all our true positive cases. Sensitivity, specificity, positive predictive value, and negative predictive value of SEMAC-MRI for component loosening compared with gold standard were 100, 97.0, 88.9, and 100% in T1W-SEMAC, 75.0, 45.5, 25.0, and 88.2% in STIR-SEMAC, and 75.0, 93.9, 75.0, and 93.9% in proton density-weighted-SEMAC. Conclusion SEMAC-MRI can accurately detect surgically verifiable prosthesis loosening and differentiate nonspecific BME from prosthesis loosening.

AIM:The management of infected diabetic foot ulcers (DFUs) requires balancing the need for timely interventions against the desire for targeted antibiotic therapy, which relies on laboratory results. This study aimed to evaluate concordance between molecular and conventional culture and sensitivity (C&S) methods in identifying bacteria from infected DFUs. METHODS:This study was conducted alongside CODIFI2, a Phase III randomised controlled trial comparing tissue sampling with wound swabbing. It assessed C&S and metagenomic 16S rRNA gene sequencing (M16S) in DFUs with suspected mild or moderate infections using both tissue and swab samples. RESULTS:In 145 participants, C&S identified 248 microorganisms across 25 genera including eight anaerobic genera. M16S identified a greater number and diversity of microorganisms, detecting 455 across 40 genera, including 173 anaerobes from 15 distinct genera. No bacterial growth was reported in 25.5% (95% CI: 18.0%-32.3%) of C&S samples, whereas M16S identified at least one organism in all samples. While the observed agreement between methods was high (75%), Cohen's Kappa revealed low concordance overall, except for Pseudomonas spp. and Streptococcus spp. (Kappa ≥ 0.5). CONCLUSIONS:M16S detected a broader microbial spectrum, including fastidious anaerobes, but its low concordance with C&S and lack of antibiotic sensitivity data, challenge its suitability as a replacement for C&S in mild or moderate DFU infections. It may offer advantages in infections where increased sensitivity is beneficial, particularly where extended culture approaches are recommended to detect fastidious or low-abundance organisms. For mild to moderate DFU infections, our findings support continued reliance on conventional C&S testing.

Background Children and young people with symptomatic pes planus (flat feet) often seek treatment from healthcare professionals. There are various treatment options, but there is a lack of high-quality evidence about which is most effective. Objectives To assess the clinical and cost-effectiveness of prefabricated orthoses, plus exercise and advice, compared with exercise and advice alone on physical function, measured using the physical domain of the Oxford Ankle Foot Questionnaire for Children, among children with symptomatic pes planus. Design and methods A pragmatic, multicentre, two-armed individually randomised controlled trial with an internal pilot, economic evaluation and qualitative study. Setting and participants Children and young people aged 6–14 years with symptomatic flat feet were recruited from hospital or community healthcare facilities in England and Wales. Participants were randomised 1 : 1 using a secure web-based randomisation system and followed up for up to 12 months. Interventions We planned to provide all participants with advice and exercises, with the intervention group also receiving a prefabricated orthosis. Due to the nature of the study treatments, blinding of participants or the research team was not possible. Main outcome measures The primary outcome was the physical domain subscale of the Oxford Ankle Foot Questionnaire for Children over the 12-month follow-up. Secondary outcomes included the physical domain subscale at 3, 6 and 12 months, and the ‘School and Play’ and ‘Emotional’ domains of the Oxford Ankle Foot Questionnaire, pain scores, healthcare resource use, EQ-5D-Y and Child Health Utility 9D at all time points. The qualitative study drew on health literacy and health belief perspectives and examined fidelity and explored the experiences of being in the trial for those receiving and delivering the study treatments. Results COVID-19 severely delayed trial set-up and recruitment and the study closed before meeting its recruitment target. Of 549 participants assessed for eligibility, 134 were randomised (intervention n = 70, control n = 64). The mean age of participants was 10.6 years (range 6.3–14.8) and 55.2% were male. No adverse events were reported. The planned statistical and health economic analyses could not be fully conducted due to the limited data. The qualitative study identified pain, posture and gait as the most common concerns by participants with pain relief as the primary motivator for seeking health care. Participants generally reported little understanding of their condition with barriers including misattribution (e.g. growing pains). Misinformation was common emphasising a need for accessible accurate education materials and structured follow-up care. There was a common belief that orthoses were superior to exercises leading to high levels of adherence, satisfaction and outcomes with orthoses compared with poor adherence, and low perceived efficacy with exercises linked to challenges incorporating these into daily routines. Limitations We could not deliver the study objectives as planned. Due to the limited data available, we were unable to undertake the planned analysis. Conclusions The COVID-19 pandemic significantly impacted trial set-up and recruitment. Extending the study was not feasible due to cost and time constraints. Future work The evidence for the clinical and cost-effectiveness of orthotics for the treatment of symptomatic flat feet in children remains inconclusive and an area for further research. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR127510.

Objective:Intra-articular corticosteroid injections are commonly used in the management of foot and ankle OA. Although current clinical guidelines advocate the judicious use of corticosteroid injection as an adjunct therapy, none of these recommendations are specific to the foot and ankle. Therefore, the aim of this review is to examine the effectiveness of intra-articular corticosteroid injections in people with foot or ankle OA. Methods:Four databases (Cumulative Index to Nursing and Allied Health Literature [CINAHL], MEDLINE, EMBASE and CENTRAL) and one clinical trial register (International Clinical Trials Registry Platform [ICTRP]) were searched from inception to June 2024 for randomized control trials (RCTs) and quasi-RCTs evaluating corticosteroid injection in the treatment of foot or ankle OA on pre-specified outcomes: pain, function, quality of life, safety (adverse events) and/or cost-effectiveness. Two independent reviewers conducted record screening, data extraction (Cochrane data extraction tool) and assessment of methodological quality (Cochrane Risk of Bias tool [RoB 2.0]). Results:From 1711 citations, two RCTs (57 participants, 49% males) were identified. There were no differences in pain or function over 8 weeks after a single injection of intra-articular corticosteroid compared with prolotherapy for treatment of first metatarsal joint OA. Pain and function significantly improved in people having three corticosteroid injections combined with hyaluronic acid compared with corticosteroid injections alone for treatment of post-traumatic subtalar OA. Methodological quality was graded as some concerns in both trials. Conclusion:There is insufficient evidence to guide the use of intra-articular corticosteroid injections for OA of the foot or ankle. Future robust research is needed to provide reliable evidence for this commonly performed treatment.

BAIMS/HYPOTHESIS:CODIFI2 compared wound swabbing and tissue sampling in people with infected diabetic foot ulcers (DFU) to determine the effects on clinical outcomes. METHODS:Multicentre, Phase III, prospective, non-blind, 2-arm parallel group, randomised controlled trial comparing time to ulcer healing (primary outcome), proportions healed, antimicrobial regimen, ulcer area reduction, hospitalisation duration, and time to death for swab compared to tissue sampling. Allocation was via a central and independent randomisation system, with minimisation by DFU site, number, type, size, location, and duration. Follow-up was 52-104 weeks, with healing confirmed by a blinded assessor. Samplesize target was 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks. RESULTS:Between May 2019 and May 2022, 149 participants were recruited (75 Swab, 74 Tissue) from 21 UK sites. The 52-week cumulative incidence of confirmed healing as the first event was 45.3% (33.5%-56.4%) and 44.6% (33.0-55.6%) for swab vs. tissue. The hazard ratio (HR) for healing for tissue vs. swab was 1.01 (95% CI 0.65-1.55). The median (IQR) days in hospital was 17 (12-39) for swab and 16 (10-32) for tissue. Seventeen swab and 7 tissue participants died during follow-up, and 18.7% and 24.3% of participants in the swab and tissue groups, respectively, had an amputation. CONCLUSIONS/INTERPRETATION:This trial was underpowered to determine whether swab or tissue sampling impacted the rate of healing or time to healing. Clinical prescribing and patient outcomes differed slightly between groups; hence, the clinical benefit of tissue sampling is not established.

Background The primary endpoint in diabetes-related foot ulcer (DFU) trials is often time to healing, defined as complete re-epithelialisation with absence of drainage, requiring clinical expert assessment as the gold standard. Central blinded photograph review for confirmation of healing is increasingly being undertaken for internal validity. The Diabetic Foot Ulcer Photography study aims to determine the agreement between blinded independent review panel members for assessing ulcer healing status in patients with DFUs.Methods and analysis Photographs of ulcers clinically assessed as healed or not healed across 300 participants recruited to one of two randomised controlled trials (MIDFUT and CODIFI2), will be independently reviewed by a central blinded panel consisting of four clinicians with expertise in ulcer healing assessment. Staff at recruiting sites will take photographs using a standardised camera and protocol. Photographs will be reviewed at three levels of magnification: raw image, image standardised to a measurement scale included in the photograph and standardised image with magnification permitted. Reviewers will assess the healing status and their confidence level in making a healing judgement, with reasons reported for a low confidence rating. Analysis at each level of magnification will estimate inter- and intra-rater reliability on the assessments of healing of photographs with the clinical assessment (primary) and confidence rating using multivariable logistic mixed models. Analysis of the learning curve for the assessment of healing and confidence rating will use exponential and two-phase models.Ethics and dissemination Ethics approval has been granted by the National Research Ethics Service Committees (MIDFUT 17/YH/0055; CODIFI2 18-WS-0235). All participants will provide a written informed consent for photography before recruited onto the respective study. Photographs will be transferred to the trials’ coordinating centre via a secure file transfer service and saved in a restricted access folder on a secure server. Results will be disseminated via publications in scientific journals and conference presentations.Trial registration number MIDFUT (ISRCTN64926597) and CODIFI2 (ISRCTN74929588).

BACKGROUND:Ingrown toenails are a common pathology. Although a range of conservative and surgical measures are widely used for this condition, little is known about their use in practice. This study explored current practice relating to the treatment or management of ingrown toenails by podiatrists in the UK. METHODS:A cross-sectional online survey (Qualtrics, Provo, UT, USA) conducted between March to June 2020 was distributed to practicing podiatrists treating or managing ingrown toenails in the UK. RESULTS:A total of 396 practicing podiatrists responded (60.1% based in the private sector). The majority (88.6%) performed nail surgery most commonly (54.3%) less than five a month. Nearly all (95%) only performed nail avulsion with or without chemical matrixectomy, universally using phenol (97.2%). Application time and number of applications varied but was most commonly applied three times (61.5%) for a total of 3 minutes (75%). Aftercare varied considerably between public and private sectors, with public sectors offering fewer follow-up appointments. CONCLUSIONS:Although there is a variation in clinical practice throughout the treatment pathway, almost all respondents offered nail avulsion with phenol matrixectomy, whereas very few provided incisional nail surgery. This data provides the most comprehensive description of how UK podiatrists conduct nail surgery for onychocryptosis.

Objective To explore the views of general practitioners and physiotherapists on the current model of care for patients with musculoskeletal disorders in Norwegian primary care, and if the English First Contact Practitioner model, where patients have access to multiple professional groups with musculoskeletal health expertise, could inform service development.Design, setting, and subjects We analysed interviews with five GPs and 11 physiotherapists and used Lipsky’s theories about street-level bureaucracy and Foucault’s theories of mechanisms of power and institutional structures to explore task shifting and cooperation between different professions.Results and interpretation The empirical material reflected a multi-faceted discourse about skill-mix in primary care, where financial factors, perceptions about competence, and task preferences moderated attitudes to task shifting. Competition and cooperation coexist between the professions, and the seemingly gradual blurring between historical hegemony and new models of care creates both alliances and rivalries. Examples of deviations from the Choosing Wisely principles and evidence-based practice indicate that both general practitioners and physiotherapists balance the roles of patient advocate, gatekeeper, and homo economicus, in a context where task shifting is challenged by established practice. It appears that the management of patients with musculoskeletal disorders is fragmented and to some extent reflects a supply-driven system.

BACKGROUND:Posterior Tibial Tendon Dysfunction (PTTD) is commonly seen within musculoskeletal care. The condition's prevalence and management is poorly understood. This study aims to demonstrate current practice by multi-professional clinicians across the United Kingdom within the National Health Service. METHODS:A national (UK) cross-sectional online survey was conducted among multi-professionals who treat PTTD within their NHS practice. The survey covered assessment, management and evaluation. This was shared via social media and professional groups. RESULTS:Two hundred thirteen surveys were completed, with 153 matching the eligibility criteria. The main respondents were Physiotherapists (48%) and Podiatrists (38%). Ultrasound scanning was used most frequently when considering initial imaging (67%). Many different treatment modalities were used, but a core set of education/advice, foot orthoses, and foot specific as well as general exercise were most commonly chosen. Outcome measures routinely used were pain scale (96/269) and single leg heel raise (84/269), but patient reported outcome measures were not routinely used. The most frequent reason to escalate care was failure to manage symptoms with conservative management (106/123; 86.2%), followed by fixed deformity (10/123; 8.2%). CONCLUSIONS:This survey provides evidence on current non-surgical management for PTTD from UK NHS practice. It provides a valuable marker for clinicians to use to compare their own practice and can be used in further research as a comparator.

Background The First Contact Practitioner role have been established in England to expand multidisciplinary working in primary care. First Contact Practitioners, including podiatrists, paramedics, physiotherapists, dietitians, and occupational therapists, undergo less foundational training than General Practitioners. Health Education England commissioned The University of Central Lancashire to deliver a module for First Contact Practitioners to support the development of the knowledge, skills, and attitudes required to provide safe and effective care in primary care. This study investigated the utility of the module as perceived by First Contact Practitioners who had completed the module and their clinical mentors, and their perceptions about how the First Contact Practitioner role meets the clinical realities of primary care. Methods Using a qualitatively driven mixed-methods approach, we collected data via online surveys and semi-structured interviews. We explored the empirical material using a reflexive and creative method, and used Lipsky’s theories on street-level bureaucracy as a theoretical frame of reference. Results Twenty-one students and six clinical mentors completed the survey, six students and two clinical mentors were interviewed. We found that perceptions about the utility of the module is influenced by personal circumstances, professional identity, and mentoring experience, and that profession-specific competence typically fall short of the capabilities required for the primary care gatekeeper role. The participants indicated that a clear definition of the First Contact Practitioner role is missing, which might sit in contrast to policymakers’ perception that there is a clear blueprint for the implementation of the role. Conclusions Our findings can inform and guide postgraduate training for healthcare professionals wanting to pursue a career in primary care, as well as employers that implement public policy at the street level. Our study can guide policymakers, who in their endeavour to improve public services must allow autonomous practitioners to interpret and show discretion in their meetings with patients, but also offer clear guidelines, job descriptions, and roadmaps.

When performing nail surgery, clinicians must choose from a multitude of procedures and variations within each procedure. Much has been published to guide this decision making, but there are a lack of up to date robust systematic reviews to assess the totality of this evidence. Five databases (MEDLINE, Embase, CINAHL, Web of Science and CENTRAL) and two registers (Clinicaltrials.gov and ISRCTN) were searched to January 2022 for randomised trials evaluating the effects of a surgical intervention(s) for ingrown toenails. Two independent reviewers screened records, extracted data, assessed risk of bias and certainty of evidence. Data on co-primary outcomes of symptom relief and symptomatic regrowth were presented in our first paper. This paper presents data for the secondary outcomes and further discussion. Of 3,928 records identified, 36 randomised trials were included in the systematic review. Healing time appears to be reduced with shorter application of phenol. A reduced healing time was also apparent was with the addition of curettage, although this may also increase the risk of post-operative bleeding and pain. Post operative bleeding was also reportedly lower in people who received local anaesthetic with epinephrine but no tourniquet. Use of phenol with nail bed excision may decrease the risk of infection. Lower pain scores were reported when using partial matrixectomy and surgical interventions with phenol. Shorter duration of pain was reported with phenolisation and wedge resection. Participant satisfaction was high overall. This second paper reports secondary outcomes from a robust systematic review of randomised trials on surgical treatment of ingrown toenails. Despite the large volume of clinical trials conducted on the topic, few clinical conclusions can be drawn due to the poor quality of these studies. Further high-quality clinical trials are needed to answer fundamental questions in the surgical treatment of ingrown toenails.

Background:The first metatarsophalangeal joint is the most common site of osteoarthritis (OA) in the foot and ankle. Intra-articular corticosteroid injections are widely used for this condition, but little is known about their use in practice. This study explored current practice within the UK National Health Service (NHS) relating to the administration of intra-articular corticosteroids for people with painful first metatarsophalangeal joint (MTPJ) OA. Methods:A cross-sectional survey using Qualtrics online survey platform (Qualtrics, Provo, UT, USA), distributed through professional bodies, special interest groups, and social media. Results:One hundred forty-four healthcare professionals responded, including podiatrists (53/144; 39%), orthopaedic surgeons (28/144; 19%), podiatric surgeons (26/144; 17%) and physiotherapists (24/144; 16%). Half of respondents administered up to 25 corticosteroid injections per year (67/136; 49%) but some administered more than fifty (21/136; 15%). Injections were administered across the healthcare system but were most common in hospital settings (64/136; 44%) followed by community (38/136; 26%), with less delivered in primary care (11/136; 8%). Half of respondents routinely used image-guidance, either ultrasound or x-ray/fluoroscopy (65/136; 48%) although over one third used none (52/136; 38%). Imaging guidance was more common amongst medical professionals (21/31; 68%) compared to non-medical health professionals (45/105; 43%). Overall, methylprednisolone acetate was the most common corticosteroid used. Medical professionals mostly injected methylprednisolone acetate (n = 15/27; 56%) or triamcinolone acetonide (n = 11/27; 41%), whereas premixed methylprednisolone acetate with lidocaine hydrochloride was the most common preparation used by non-medical health professionals (41/85; 48%). When injecting non premixed steroid, lidocaine hydrochloride (15/35; 43%) was the most common choice of local anaesthetic for non-medical health professionals but medical professionals showed more variation between lidocaine hydrochloride (8/23; 35%) levobupivacaine hydrochloride (9/23; 39%) and bupivacaine hydrochloride (5/23; 22%). Conclusions: Multiple professional groups regularly administer intra-articular corticosteroids for symptomatic first MTPJ OA across a range of NHS healthcare settings. Overall, methylprednisolone acetate was the most commonly administered steroid and lidocaine hydrochloride the most common local anaesthetic. There was large variation in the use of imaging guidance, type and dose of steroid, local anaesthetic, and clinical pathways used in the intra-articular injection of corticosteroids for people with first MTPJ OA.

Background:Fibromyalgia presents a challenge to both the patients experiencing symptoms and the staff aiming to treat them. This qualitative review aimed to synthesise how patients and practitioners experience primary care consultations, develop a rounded picture of how they perceive each other, the challenges to primary care consultation and how they might be tackled.Methods:CINAHL, Embase, CENTRAL and Medline were searched from inception to November 2021. Qualitative studies were included if they explored the perspectives and experiences of either fibromyalgia patients or primary care practitioners. Quantitative data, studies not published in English, not set in primary care or that did not distinguish the type of patient or clinician were excluded. Included studies were analysed using thematic synthesis and their quality assessed.Results:In total, 30 studies met the inclusion criteria. Thematic synthesis identified three overarching themes: (1) life turned upside down - exploring the chaos experienced by patients as they seek help; (2) negative cycle - highlighting how patient and practitioner factors can create a detrimental cycle; and (3) breaking the cycle - validating patient-doctor relationships underpinned by clear communication can help break the negative cycle.Conclusions:Fibromyalgia patients experience uncertainty and chaos that can clash with the attitudes of GPs and the help they can feasibly provide. Difficult consultations in which neither the GP nor patient are satisfied can easily occur. Promoting supportive, reciprocal and open patient-doctor relationships is essential. Future research is required to further explore GP attitudes and to develop an intervention that could improve consultations, patient outcomes and GP satisfaction.

BackgroundIngrown toenails are a common nail pathology. When conservative treatments are ineffective, a surgical approach is often utilised. Despite recent narrative reviews, there is a need for an up-to-date and rigorous systematic review of surgical methods for treating ingrown toenails.MethodsFive databases (MEDLINE, Embase, CINAHL, Web of Science and CENTRAL) and two registers (Clinicaltrials.gov and ISRCTN) were searched to January 2022 for randomised trials evaluating the effects of a surgical intervention(s) for ingrown toenails with a follow-up of at least 1 month. Two independent reviewers screened records, extracted data, assessed risk of bias and certainty of evidence.ResultsOf 3,928 records identified, 36 (3,756 participants; 62.7% males) surgical interventions were included in the systematic review and 31 studies in the meta-analysis. There was very low quality evidence that using phenol with nail avulsion vs nail avulsion without phenol reduces the risk of recurrence (risk ratio [RR] 0.13 [95% CI 0.06 to 0.27], p < 0.001). No favourable effect was observed between chemical or surgical vs conservative management (0.55 [0.19 to 1.61], p = 0.280; 0.72 [0.33 to 1.56], p = 0.410), chemical or surgical vs other (e.g., CO2 laser, electrocautery) (1.61 [0.88 to 2.95], p = 0.120; 0.58 [0.25 to 1.37], p = 0.220), chemical vs surgical (0.75 [0.46 to 1.21], p = 0.230), surgical vs surgical (0.42 [0.21 to 0.85]), chemical vs chemical (0.19 [0.01 to 3.80], p = 0.280), surgical vs surgical + chemical (3.68 [0.20 to 67.35], p = 0.380), chemical vs surgical + chemical (1.92 [0.06 to 62.30], p = 0.710), local anaesthetic vs local anaesthetic + adrenaline (1.03 [0.22 to 4.86], p = 0.970), chemical timings 30 s vs 60 s (2.00 [0.19 to 21.41]) or antibiotics vs no antibiotics (0.54 [0.12 to 2.52], p = 0.430). Central toenail resection was the only procedure to significantly relieve symptoms (p = 0.001) but data were only available up to 8 weeks post-surgery.ConclusionDespite the high number of publications, the quality of research was poor and the conclusions that can be inferred from existing trials is limited. Phenolisation of the nail matrix appears to reduce the risk of recurrence following nail ablation, and with less certainty 1 min appears to be the optimum time for application. Despite this being a widely performed procedure there remains a lack of good quality evidence to guide practice.

OBJECTIVE:Recurrent diabetic foot ulcers (DFUs) are associated with poor health-related quality of life and reduced mobility. Current guidelines recommend application of non-removable offloading devices (NROLDs) as they may improve the healing of DFUs, but there is a lack of information on the wider effects of wearing these devices. Few studies have examined the impact of NROLDs on holistic wellbeing or physical activity. We aimed to investigate the short-term impact of NROLDs on physical activity and DFU-related quality of life (DFU-QoL) in a small sample of community-dwelling people with recurrent DFUs.METHOD:We measured DFU-QoL and physical activity (GPAQ) in people with DFUs, recruited from a single clinic before NROLD application, and at three and six weeks after device fitting. Participants were aged from 39-81 years (mean 58.4±10.1 years) with an equal number of male and female participants.RESULTS:The study cohort comprised 18 participants, of whom 14 (78%) completed six-week questionnaires. Although there was some interim decline observed within individual domains of the DFU-QoL (financial: mean difference (MD) 16.2 (95% confidence interval (CI) 2.1, 30.2); p=0.03); non-compliance: MD 12.5 (95% CI-0.2, 25.2); p=0.05), no differences were observed over six weeks. Levels of physical activity declined over time, with over half (56%) of participants classified as having low levels of physical activity at baseline, rising to two-thirds (67%) at follow-up.CONCLUSION:Future studies should explore the longer-term holistic impact of NROLDs and develop more personalised approaches to care at the point of prescription, during and post-device use.

This study aimed to develop and evaluate a new step-count algorithm, StepMatchDTWBA, for the accurate measurement of physical activity using wearable devices in both healthy and pathological populations. We conducted a study with 30 healthy volunteers wearing a wrist-worn MOX accelerometer (Maastricht Instruments, NL). The StepMatchDTWBA algorithm used dynamic time warping (DTW) barycentre averaging to create personalised templates for representative steps, accounting for individual walking variations. DTW was then used to measure the similarity between the template and accelerometer epoch. The StepMatchDTWBA algorithm had an average root-mean-square error of 2 steps for healthy gaits and 12 steps for simulated pathological gaits over a distance of about 10 m (GAITRite walkway) and one flight of stairs. It outperformed benchmark algorithms for the simulated pathological population, showcasing the potential for improved accuracy in personalised step counting for pathological populations. The StepMatchDTWBA algorithm represents a significant advancement in accurate step counting for both healthy and pathological populations. This development holds promise for creating more precise and personalised activity monitoring systems, benefiting various health and wellness applications.

Offloading devices improve healing of diabetes-related foot ulcers (DFUs) but they can limit mobilisation. Rehabilitation during or after removal of these devices may promote physical activity in a population at risk of poor health outcomes for which inactivity is a reversible risk factor. This systematic review examined the effectiveness of rehabilitation interventions to promote physical activity during and/or after wearing an offloading device to treat diabetes-related foot ulcers. Searches using MESH terms and free-text combinations: ‘foot ulcer’, ‘diabetic foot’, ‘casts, surgical’, ‘orthotic devices’ were applied to MEDLINE, Embase, The Cochrane Library and clinical trial registers for randomised and observational studies published to September 2022. Methodological quality assessment of included studies was undertaken using the Cochrane Risk of Bias (RoB 2.0) and Risk of Bias In Non-randomised studies of Interventions (ROBINS-I) tools. Of 3332 records identified, eight studies (441 participants), four clinical trials and four cohort studies, were included. None delivered or tested a structured rehabilitation programme, but all reported physical activity outcomes during or after device use. People wearing non-removable total contact casts were less active than those wearing devices (SMD -0.45; 95

Background Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and related complications. INFIX is a pelvic fixation device used in younger patients with high-energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients’ ability to mobilise and reduce the risk of immobility-related complications. However, there is a risk of complications related to surgery, and robust evidence is required on patient outcomes. This study will investigate the clinical and cost-effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications. Discussion The L1FE study aims to compare the clinical and cost-effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision-making and allocation of NHS resources. Trial registration International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019

Background Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. Methods We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. Results In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. Conclusions Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.