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Acta Dermatovenerologica Croatica : ADC Mar 2024Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking. (Observational Study)
Observational Study
The Safety Profiles of Adalimumab, Infliximab, Etanercept, Secukinumab and Ustekinumab in Psoriasis - A 30-month Observational Cohort Prospective Study of Adverse Events in Biologic Therapy.
BACKGROUND
Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking.
METHODS
A total of 124 patients with psoriasis were followed up for 30 months; 74 received anti-TNF-alpha inhibitors (adalimumab, etanercept, infliximab), 33 were on ustekinumab, and 17 were treated with secukinumab. The rates of adverse events in these groups were recorded and statistically analyzed.
RESULTS
Infliximab-treated patients showed a high occurrence of asymptomatic, but increased liver enzymes, fatigue, and respiratory as well as dermatologic infections. Adalimumab-treated patients were more often affected by musculoskeletal disorders and infections of all types. Patients treated with secukinumab presented with higher rates of cardiovascular disorders as well as respiratory and dermatologic infections. The group receiving etanercept was more often diagnosed with musculoskeletal and reproductive disorders, specifically menstrual disorders. The rates of therapy discontinuation and serious adverse events did not reach statistically significant values.
CONCLUSION
A higher incidence of adverse events was observed among adalimumab-, and infliximab-treated patients, with ustekinumab found to have the safest profile. Our results demonstrate that a personalized approach, including evaluation of a patient's risk profile, is necessary before commencing a biologic. Further research is warranted to confirm the findings of our study.
Topics: Humans; Psoriasis; Female; Male; Ustekinumab; Prospective Studies; Adalimumab; Infliximab; Middle Aged; Adult; Etanercept; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Cohort Studies; Dermatologic Agents
PubMed: 38946182
DOI: No ID Found -
The Bone & Joint Journal Jul 2024Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are... (Randomized Controlled Trial)
Randomized Controlled Trial
AIMS
Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty - the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most.
METHODS
We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure health-related quality of life at one, four, and 12 months postoperatively.
RESULTS
Our analysis revealed a complex landscape of responses to the use of a cemented hemiarthroplasty in the 12 months after surgery. There was heterogeneity of effects with regard to baseline characteristics, including age, pre-injury health status, and lifestyle factors such as alcohol consumption. This heterogeneity was greater at the one-month mark than at subsequent follow-up timepoints, with particular regard to subgroups based on age. However, for all subgroups, the effect estimates for quality of life lay within the confidence intervals derived from the analysis of all patients.
CONCLUSION
The use of a cemented hemiarthroplasty is expected to increase health-related quality of life compared with modern uncemented hemiarthroplasty for all subgroups of patients aged > 60 years with a displaced intracapsular fracture of the hip.
Topics: Humans; Hemiarthroplasty; Aged; Female; Male; Quality of Life; Middle Aged; Bone Cements; Aged, 80 and over; Treatment Outcome; Femoral Neck Fractures; Cementation; Arthroplasty, Replacement, Hip
PubMed: 38945545
DOI: 10.1302/0301-620X.106B7.BJJ-2024-0267 -
The Lancet. Rheumatology Jun 2024Autoimmune rheumatic diseases have distinct pathogenic mechanisms and are causes of disability and increased mortality worldwide. In this study, we aimed to examine...
Annual trends in pain management modalities in patients with newly diagnosed autoimmune rheumatic diseases in the USA from 2007 to 2021: an administrative claims-based study.
BACKGROUND
Autoimmune rheumatic diseases have distinct pathogenic mechanisms and are causes of disability and increased mortality worldwide. In this study, we aimed to examine annual trends in pain management modalities among patients with autoimmune rheumatic diseases.
METHODS
We identified newly diagnosed patients with ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, Sjögren's syndrome, systemic sclerosis, or systemic lupus erythematosus (SLE) in the Merative Marketscan Research Databases from 2007 to 2021. The database includes deidentified inpatient and outpatient health encounters with employment-sponsored health insurance claims in the USA. We found minimal occurrences of multiple overlapping conditions and included only the initial recorded diagnosis for each patient. We determined the annual incidence of patients treated with opioids, anticonvulsants, antidepressants, skeletal muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), topical analgesics, and physical therapy in the year following diagnosis. Logistic regression was used to estimate the association between calendar year and outcomes, adjusted for age, sex, and region.
FINDINGS
We included 141 962 patients: 10 927 with ankylosing spondylitis, 21 438 with psoriatic arthritis, 71 393 with rheumatoid arthritis, 16 718 with Sjögren's syndrome, 18 018 with SLE, and 3468 with systemic sclerosis. 107 475 (75·7%) were women and 34 487 (24·3%) were men. Overall, the incidence of opioid use increased annually until 2014 by 4% (adjusted odds ratio [aOR] 1·04 [95% CI 1·03-1·04]) and decreased annually by 15% after 2014 (0·85 [0·84-0·86]). The incidence of physical therapy use increased annually by 5% until 2014 (aOR 1·05 [95% CI 1·04-1·06]), with a slight decrease annually by 1% after 2014 (0·99 [0·98-1·00]). The incidence of anticonvulsant use increased annually by 7% until 2014 (aOR 1·07 [95% CI 1·07-1·08]) and did not significantly change after 2014 (1·00 [0·99-1·00]). Before 2014, the incidence of NSAIDs use increased by 2% annually (aOR 1·02 [95% CI 1·02-1·03]); however, after 2014, the incidence decreased annually by 5% (0·95 [0·95-0·96]). These trends did not differ by sex except for NSAID use before 2014 (p=0·02) and topical analgesic use after 2014 (p=0·0100).
INTERPRETATION
Since 2014, the use of non-opioid pain management modalities has increased or stabilised, whereas opioid and NSAID use has declined. Future studies are needed to evaluate the effectiveness of these changes, and the effects they have had on outcomes such as quality of life, disability, and function.
FUNDING
National Institute of Arthritis and Musculoskeletal and Skin Diseases.
PubMed: 38945137
DOI: 10.1016/S2665-9913(24)00120-6 -
The Lancet. Healthy Longevity Jul 2024Little is known about ageing and frailty progression in low-income settings. We aimed to describe frailty changes over time in individuals living in rural Burkina Faso...
BACKGROUND
Little is known about ageing and frailty progression in low-income settings. We aimed to describe frailty changes over time in individuals living in rural Burkina Faso and to assess which sociodemographic, disability, and multimorbidity factors are associated with frailty progression and mortality.
METHODS
This longitudinal, population-based study was conducted at the Nouna Health and Demographic Surveillance Systems (HDSS) site in northwestern Burkina Faso. Eligible participants were aged 40 years or older and had been primarily resident in a household within the HDSS area for at least the past 6 months before the baseline survey and were selected from the 2015 HDSS household census using a stratified random sample of adults living in unique households within the area. Participants were interviewed in their homes in 2018 (baseline), 2021 (follow-up), or both. We derived the Fried frailty score for each participant at each timepoint using data on grip strength, gait speed, self-reported weight loss, self-reported exhaustion, and physical activity, and described changes in frailty status (no frailty, pre-frailty, or frailty) between 2018 and 2021. We used multivariate regression models to assess factors (ie, sex, age, marital status, educational attainment, wealth quintile, WHO Disability Assessment Schedule (WHODAS) score, and multimorbidity) associated with frailty progression (either worsening frailty status or dying, compared with frailty status remaining the same or improving) and with mortality, and developed sequential models: unadjusted, adjusting for sociodemographic factors (sex, age, marital status, educational attainment, and wealth quintile), and adjusting for sociodemographic factors, disability, and multimorbidity.
FINDINGS
Between May 25 and July 19, 2018, and between July 1 and Aug 22, 2021, 5952 individuals were invited to participate: 1709 (28·7%) did not consent, 1054 (17·8%) participated in 2018 only and were lost to follow-up, 1214 (20·4%) participated in 2021 only, and 1975 (33·2%) were included in both years or died between years. Of 1967 participants followed up with complete demographic data, 190 (9·7%) were frail or unable to complete the frailty assessment in 2018, compared with 77 (3·9%) in 2021. Between 2018 and 2021, frailty status improved in 567 (28·8%) participants and worsened in 327 (16·6%), and 101 (5·1%) participants died. The relative risk of frailty status worsening or of dying (compared with frailty impRoving or no change) increased with age and WHODAS score, whereas female sex appeared protective. After controlling for all sociodemographic factors, multimorbidity, and WHODAS score, odds of mortality were 1·07 (odds ratio 2·07, 95% CI 1·05-4·09) times higher among pre-frail individuals and 1·1 (2·21, 0·90-5·41) times higher among frail individuals than among non-frail individuals.
INTERPRETATION
Frailty status was highly dynamic in this low-income setting and appears to be modifiable. Given the rapid increase in the numbers of older adults in low-income or middle-income countries, understanding the behaviour of frailty in these settings is of high importance for the development of policies and health systems to ensure the maintenance of health and wellbeing in ageing populations. Future work should focus on designing context-appropriate interventions to improve frailty status.
FUNDING
Alexander Von Humboldt Foundation, Institute for Global Innovation, University of Birmingham, and Wellcome Trust.
Topics: Humans; Male; Female; Longitudinal Studies; Aged; Middle Aged; Frailty; Burkina Faso; Rural Population; Adult; Disease Progression; Aged, 80 and over; Frail Elderly
PubMed: 38945131
DOI: 10.1016/S2666-7568(24)00096-5 -
Journal of Plastic, Reconstructive &... Jun 2024Soft tissue facial injuries (STFI) constitute a huge portion of craniofacial trauma, but the risk of surgical site infection (SSI) and patient-reported outcomes (PROs)...
BACKGROUND
Soft tissue facial injuries (STFI) constitute a huge portion of craniofacial trauma, but the risk of surgical site infection (SSI) and patient-reported outcomes (PROs) following surgical management of STFI are unknown.
METHODS
A PRISMA-compliant search was conducted from January 1990 until March 2023, and meta-analysis was performed using R. Pooled effects of the outcomes were estimated using the DerSimonian and Laird random-effects model or generalised linear mixed model, when feasible.
RESULT
Among the 8897 screened studies, 38 were included. Twelve studies reported PROMs (n = 985), whereas 28 studies reported SSI rates (n = 10,996) following operative treatment for STFI. The pooled SSI rate (n = 28) was 3.30 % (95 % CI 1.89 %-5.71 %). Surgical and non-surgical closure did not differ significantly in SSI rate. PROs focused on scar outcomes, cosmetic outcomes, quality of life and psychological impact. Subgroup analysis showed lower SSI risk in operative repair for general facial trauma compared to primary repair, and in general facial trauma compared to other aetiologies. The pooled patient scar assessment scale, score at 6-12 months post-intervention (5 studies, n = 217) was 16.16 (95 % CI 15.34-16.97). Limited evidence is available on the effect and superiority of surgical treatment in cosmetic outcomes, quality of life and psychological impact.
CONCLUSION
Our findings emphasise the limited and unreliable evidence available on PROs following operative treatment for STFI. Future studies employing robust methodologies are needed to investigate optimal approaches for managing STFI.
PubMed: 38945111
DOI: 10.1016/j.bjps.2024.06.004 -
Journal of Electromyography and... Jun 2024This study aimed to develop an insertion technique for intramuscular EMG recording of the oblique head of adductor hallucis (AddH) and first dorsal interosseous (FDI)...
This study aimed to develop an insertion technique for intramuscular EMG recording of the oblique head of adductor hallucis (AddH) and first dorsal interosseous (FDI) muscles in humans via the dorsum of the foot, and report feasibility of intramuscular EMG data acquisition during walking in shoes. In eight individuals without musculoskeletal pain or injury (5 males; 32 ± 8 years), intramuscular electrodes were inserted into AddH (oblique head) and FDI through the right foot's dorsum (between metatarsals I-II) with ultrasound guidance. The ultrasound transducer was positioned on the plantar surface. Intramuscular EMG was also recorded from abductor hallucis, tibialis posterior, flexor digitorum longus and peroneus longus. Participants performed six overground walking trials wearing modified shoes, and rated pain associated with the intramuscular electrodes during walking (numerical rating scale, 0-10). High-quality EMG recordings were obtained from intrinsic and extrinsic foot muscles. Analyses of power spectral densities indicated that movement artefacts commonly observed during gait were removed by filtering. Pain associated with AddH/FDI electrodes during walking was low (median[IQR] 1[2]; range 0-4) and similar to other sites. Findings demonstrate that intramuscular EMG recording from AddH (oblique head) and FDI using this insertion technique is feasible and associated with minimal pain when walking in shoes.
PubMed: 38945047
DOI: 10.1016/j.jelekin.2024.102914 -
Computers in Biology and Medicine Jun 2024Virtual and augmented reality surgical simulators, integrated with machine learning, are becoming essential for training psychomotor skills, and analyzing surgical...
BACKGROUND
Virtual and augmented reality surgical simulators, integrated with machine learning, are becoming essential for training psychomotor skills, and analyzing surgical performance. Despite the promise of methods like the Connection Weights Algorithm, the small sample sizes (small number of participants (N)) typical of these trials challenge the generalizability and robustness of models. Approaches like data augmentation and transfer learning from models trained on similar surgical tasks address these limitations.
OBJECTIVE
To demonstrate the efficacy of artificial neural network and transfer learning algorithms in evaluating virtual surgical performances, applied to a simulated oblique lateral lumbar interbody fusion technique in an augmented and virtual reality simulator.
DESIGN
The study developed and integrated artificial neural network algorithms within a novel simulator platform, using data from the simulated tasks to generate 276 performance metrics across motion, safety, and efficiency. Innovatively, it applies transfer learning from a pre-trained ANN model developed for a similar spinal simulator, enhancing the training process, and addressing the challenge of small datasets.
SETTING
Musculoskeletal Biomechanics Research Lab; Neurosurgical Simulation and Artificial Intelligence Learning Centre, McGill University, Montreal, Canada.
PARTICIPANTS
Twenty-seven participants divided into 3 groups: 9 post-residents, 6 senior and 12 junior residents.
RESULTS
Two models, a stand-alone model trained from scratch and another leveraging transfer learning, were trained on nine selected surgical metrics achieving 75 % and 87.5 % testing accuracy respectively.
CONCLUSIONS
This study presents a novel blueprint for addressing limited datasets in surgical simulations through the strategic use of transfer learning and data augmentation. It also evaluates and reinforces the application of the Connection Weights Algorithm from our previous publication. Together, these methodologies not only enhance the precision of performance classification but also advance the validation of surgical training platforms.
PubMed: 38944904
DOI: 10.1016/j.compbiomed.2024.108809 -
Journal of Gastrointestinal and Liver... Jun 2024The environmental factors, apart from gluten ingestion predisposing to coeliac disease are poorly known. Smoking is associated with many immune-mediated diseases, but...
BACKGROUND AND AIMS
The environmental factors, apart from gluten ingestion predisposing to coeliac disease are poorly known. Smoking is associated with many immune-mediated diseases, but research on coeliac disease is scarce. This study aims to investigate how smoking affects the clinical presentation, presence of comorbidities and response to gluten-free diet in coeliac disease.
METHODS
Altogether 815 adults with coeliac disease participated in a nationwide cross-sectional study. Participants were interviewed and smoking habits (never, former, or current smoker), clinical presentation of coeliac disease and presence of comorbidities were elicited. Serology and severity of small bowel mucosal lesions at diagnosis were gathered from the participants' medical records and follow-up serology was measured. Gastrointestinal symptoms and psychological well-being were assessed using validated questionnaires.
RESULTS
Current smokers were more often male and were diagnosed at younger ages than never or former smokers. There were no differences between the groups in clinical presentation, severity of symptoms or mucosal lesions at diagnosis or in dietary compliance and clinical, serological, and histological recovery. Musculoskeletal disorders, particularly osteoporosis and osteopenia, were more common in never smokers than in other groups (14.5% vs. 5.1% and 4.1%, p<0.001), and cardiovascular disorders were diagnosed more often in former smokers (36.2% vs. 23.5% and 21.9%, p=0.003).
CONCLUSIONS
Smoking does not seem to have an impact on the clinical presentation, severity of symptoms or mucosal damage in coeliac disease. Histological and clinical recovery as well as seroconversion on gluten-free diet are not affected by smoking status.
Topics: Humans; Celiac Disease; Male; Female; Cross-Sectional Studies; Middle Aged; Diet, Gluten-Free; Adult; Cigarette Smoking; Aged; Treatment Outcome; Comorbidity; Risk Factors; Smokers; Ex-Smokers; Intestinal Mucosa
PubMed: 38944862
DOI: 10.15403/jgld-5364 -
Foot and Ankle Surgery : Official... Jun 2024Venous thrombo-embolism (VTE) is a recognised complication of foot and ankle surgery. There are multiple possible anticoagulation treatments available in the UK to...
INTRODUCTION
Venous thrombo-embolism (VTE) is a recognised complication of foot and ankle surgery. There are multiple possible anticoagulation treatments available in the UK to mitigate the risk of developing VTE. Our primary objective was to assess the variability of chemical anticoagulation prescribed in patients undergoing foot and ankle procedures.
METHODS
This was a UK-based national, multicenter, prospective audit spanning a collection duration of 9 months on all foot and ankle procedures, carried out in 68 UK centers between 1st June 2022 and 30th November 2022, with a further 3-month follow up period. All patients who underwent a foot and ankle surgical procedure (including Achilles tendon rupture treatment) were included in this study.
RESULTS
Data on a total of 13,569 patients was submitted. Following data cleansing, 11,363 patients were available for further analysis, with anticoagulation data available for 11,099 patients. There were eleven different chemical anticoagulation treatments recorded across the cohort. A total of 3630 (31.95 %) patients received no chemical anticoagulation. The patients receiving chemical anticoagulation medication could be split into 4 main groups. The most common chemical anticoagulation received was low molecular weight heparin (LMWH) (6303, 84.4 % of patients receiving chemical anticoagulation). Aspirin was given in 4.1 % (308 patients), a Factor Xa inhibitor in 10 % (744 patients) and other anticoagulants (e.g. Warfarin) in 1.5 % (114 patients). The overall VTE rate in this sub analysis of patients receiving chemical anticoagulation, was 1.1 % (83 cases out of 7469). There was no significant difference seen in incidence of VTE between types of anticoagulants, when confounding factors were considered. The duration of post-operative chemical prophylaxis used by participants for most chemical anticoagulants was 6 weeks (64.50 %).
CONCLUSION
There was significant variability of chemical anticoagulants reported in the study, with five different categories of anticoagulants used (including no chemical anticoagulation), and none clearly superior/inferior. The duration of anticoagulation was consistent across types of thromboprophylaxis.
PubMed: 38944567
DOI: 10.1016/j.fas.2024.06.005 -
Seminars in Nuclear Medicine Jun 2024Recent advancements in PET technology have culminated in the development of total-body PET (TB-PET) systems, which overcome many limitations of traditional scanners.... (Review)
Review
Recent advancements in PET technology have culminated in the development of total-body PET (TB-PET) systems, which overcome many limitations of traditional scanners. These TB-PET scanners, while still becoming widely available, represent the forefront of clinical imaging across numerous medical institutions worldwide. Early clinical applications have demonstrated their enhanced image quality, precise lesion quantification, and overall superior performance relative to conventional scanners. The capabilities of TB-PET technology, including extended scan range, ultrahigh sensitivity, exceptional temporal resolution, and dynamic imaging, offer significant potential to tackle unresolved clinical challenges in medical imaging. In this discussion, we aim to explore the emerging applications, opportunities, and future perspectives of TB-PET/CT in musculoskeletal disorders (MSDs). Clinical applications for both oncologic and non-oncologic musculoskeletal diseases are discussed, including inflammatory arthritis, infections, osteoarthritis, osteoporosis, and skeletal muscle disorders. From the ability to visualize small musculoskeletal structures and the entire axial and appendicular skeleton, TB-PET shows significant potential in the diagnosis and management of MSD conditions as it becomes more widely available.
PubMed: 38944556
DOI: 10.1053/j.semnuclmed.2024.05.009