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Health Technology Assessment... Jan 2024Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the age of 5 years, but it can develop at any age. Atopic dermatitis is characterised by dry, inflamed skin accompanied by intense itchiness (pruritus).
OBJECTIVES
To appraise the clinical and cost effectiveness of abrocitinib, tralokinumab and upadacitinib within their marketing authorisations as alternative therapies for treating moderate-to-severe atopic dermatitis compared to systemic immunosuppressants (first-line ciclosporin A or second-line dupilumab and baricitinib).
DATA SOURCES
Studies were identified from an existing systematic review (search date 2019) and update searches of electronic databases (MEDLINE, EMBASE, CENTRAL) to November 2021, from bibliographies of retrieved studies, clinical trial registers and evidence provided by the sponsoring companies of the treatments under review.
METHODS
A systematic review of the clinical effectiveness literature was carried out and a network meta-analysis undertaken for adults and adolescents at different steps of the treatment pathway. The primary outcome of interest was a combined response of Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4; where this was consistently unavailable for a step in the pathway, an analysis of Eczema Area and Severity Index 75 was conducted. A de novo economic model was developed to assess cost effectiveness from the perspective of the National Health Service in England. The model structure was informed through systematic review of the economic literature and by consulting clinical experts. Effectiveness data were obtained from the network meta-analysis. Costs and utilities were obtained from the evidence provided by sponsoring companies and standard UK sources.
RESULTS
Network meta-analyses indicate that abrocitinib 200 mg and upadacitinib 30 mg may be more effective, and tralokinumab may be less effective than dupilumab and baricitinib as second-line systemic therapies. Abrocitinib 100 mg and upadacitinib 15 mg have a more similar effectiveness to dupilumab. Upadacitinib 30 and 15 mg are likely to be more effective than ciclosporin A as a first-line therapy. Upadacitinib 15 mg, abrocitinib 200 and 100 mg may be more effective than dupilumab in adolescents. The cost effectiveness of abrocitinib and upadacitinib for both doses is dependent on the subgroup of interest. Tralokinumab can be considered cost-effective as a second-line systemic therapy owing to greater cost savings per quality-adjusted life-year lost.
CONCLUSIONS
The primary strength of the analysis of the three new drugs compared with current practice for each of the subpopulations is the consistent approach to the assessment of clinical and cost effectiveness. However, the conclusions are limited by the high uncertainty around the clinical effectiveness and lack of data for the primary outcome for comparisons with baricitinib and for the adolescent and adult first-line populations.
FUTURE WORK AND LIMITATIONS
The most significant limitation that Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4 could not be obtained for the adolescent and adult first-line systemic treatment populations is due to a paucity of data for dupilumab and ciclosporin A. A comparison of the new drugs against one another in addition to current practice would be beneficial to provide a robust view on which treatments are the most cost-effective.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42021266219.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: 135138) and is published in full in ; Vol. 28, No. 4. See the NIHR Funding and Awards website for further award information.
Topics: Child; Adult; Adolescent; Humans; Child, Preschool; Dermatitis, Atopic; Cyclosporine; State Medicine; Treatment Outcome; Cost-Benefit Analysis; Eczema; Antibodies, Monoclonal; Purines; Heterocyclic Compounds, 3-Ring; Sulfonamides; Pyrazoles; Pyrimidines; Azetidines
PubMed: 38343072
DOI: 10.3310/LEXB9006 -
Journal of Clinical Medicine Jun 2023Allograft urolithiasis is an uncommon, challenging, and potentially dangerous clinical problem. Treatment of allograft stones includes external shockwave lithotripsy... (Review)
Review
BACKGROUND
Allograft urolithiasis is an uncommon, challenging, and potentially dangerous clinical problem. Treatment of allograft stones includes external shockwave lithotripsy (SWL), flexible ureteroscopy and lasertripsy (fURSL), or percutaneous nephrolithotomy (PCNL). A gap in the literature and guidelines exists regarding the treatment of patients in this setting. The aim of this systematic review was to collect preoperative and treatment characteristics and evaluate the outcomes of post-transplant SWL for stone disease.
METHODS
A systematic search in the literature was performed, including articles up to March 2023. Only original English articles were selected.
RESULTS
Eight articles (81 patients) were included in the review. Patients were mainly male, with a mean age of 41.9 years (±7.07). The mean stone size was 13.18 mm (±2.28 mm). Stones were predominantly located in the kidney ( = 18, 62%). The overall stone-free rate and complication rates were 81% (range: 50-100%) and 17.2% (14/81), respectively, with only one major complication reported. A pre-operative drainage was placed in eleven (13.5%) patients. Five patients (6.71%) required a second treatment for residual fragments.
CONCLUSIONS
SWL is a safe and effective option to treat de novo stones after transplantation. Larger studies are needed to better address allograft urolithiasis management.
PubMed: 37445423
DOI: 10.3390/jcm12134389 -
Annals of Indian Academy of Neurology 2023COVID-19 infection is associated with neurological manifestations, including various types of movement disorders (MD). A thorough review of individual patients with...
BACKGROUND
COVID-19 infection is associated with neurological manifestations, including various types of movement disorders (MD). A thorough review of individual patients with COVID-19-induced MD would help in better understanding the clinical profile and outcome of these patients and in prognostication.
OBJECTIVE
We conducted an individual patient-systematic review to study the clinical and imaging profile and outcomes of patients with COVID-19-associated MD.
METHODS
A systematic literature search of PubMed, EMBASE, and Cochrane databases was conducted by two independent reviewers. Individual patient data COVID from case reports and case series on COVID-19-associated MD, published between December 2019 and December 2022, were extracted and analyzed.
RESULTS
Data of 133 patients with COVID-19-associated MD from 82 studies were analyzed. Mean age was 55 ± 18 years and 77% were males. A mixed movement disorder was most commonly seen (41%); myoclonus-ataxia was the most frequent (44.4%). Myoclonus significantly correlated with age (odds ratio (OR) 1.02 = 0.03, CI 1-1.04). Tremor had the longest latency to develop after SARS-CoV-2 infection [median (IQR) 21 (10-40) days, = 0.009, CI 1.01-1.05]. At short-term follow-up, myoclonus improved (OR 14.35, value = 0.01, CI 1.71-120.65), whereas parkinsonism (OR 0.09, value = 0.002, CI 0.19-0.41) and tremor (OR 0.16, value = 0.016, CI 0.04-0.71) persisted.
CONCLUSION
Myoclonus-ataxia was the most common movement disorder after COVID-19 infection. Myoclonus was seen in older individuals and usually improved. Tremor and parkinsonism developed after a long latency and did not improve in the short-term.
PubMed: 38022478
DOI: 10.4103/aian.aian_572_23 -
Rheumatology and Therapy Feb 2024Primary Sjögren's is a multi-system autoimmune disease affecting patients' physical, mental, and emotional wellbeing. The epidemiology of Sjögren's is not well... (Review)
Review
INTRODUCTION
Primary Sjögren's is a multi-system autoimmune disease affecting patients' physical, mental, and emotional wellbeing. The epidemiology of Sjögren's is not well understood, and up-to-date epidemiological evidence is needed to improve knowledge and awareness of Sjögren's among patients and healthcare professionals, and to ascertain the global burden of disease. The objective of this research was to conduct a de novo systematic literature review (SLR) to identify and synthesise evidence on global epidemiology of primary Sjögren's.
METHODS
This SLR was conducted in May 2021 by searching MEDLINE and Embase databases, relevant conference proceedings, websites of registries, and health technology assessment agencies and databases. Publications were systematically screened for English language articles reporting on the incidence, prevalence, age at symptom onset, and age at diagnosis for people with primary Sjögren's.
RESULTS
Of 3510 records identified, 68 publications were included, representing 62 unique studies. Studies reported on age at symptom onset (16/62; 25.8%) and age at diagnosis (43/62; 69.4%) more frequently than incidence (7/62; 11.3%) and prevalence (9/62; 14.5%). Primary Sjögren's was found to have the highest incidence and prevalence in females and in older age groups (incidence: ≥65 years; prevalence: ≥75 years). Average age at onset and diagnosis of primary Sjögren's ranged between 34-57 years and 40-67 years, respectively.
CONCLUSIONS
This SLR identified a paucity of incidence and prevalence data for primary Sjögren's, highlighting a need for further epidemiological studies. The global Sjögren's community must work together to follow the defined classification criteria of primary Sjögren's and reporting guidelines for incidence and prevalence data to allow for meaningful epidemiological comparisons across studies, settings, and countries.
PubMed: 37948031
DOI: 10.1007/s40744-023-00611-8 -
Dermatology and Therapy Jan 2024Drugs and vaccines have been less studied as inducing or aggravating factors for psoriatic arthritis (PsA) compared with psoriasis. Thus, the present study collected and... (Review)
Review
INTRODUCTION
Drugs and vaccines have been less studied as inducing or aggravating factors for psoriatic arthritis (PsA) compared with psoriasis. Thus, the present study collected and summarized the publications to date about this issue.
METHODS
We conducted a systematic literature search through the PubMed, Embase, and Cochrane databases to identify all reports on potential drug- and vaccine-related PsA events until 28 February 2023.
RESULTS
In total, 179 cases from 79 studies were eligible for study. Drugs commonly reported include coronavirus disease 2019 (COVID-19) mRNA vaccines (6 cases), bacillus Calmette-Guerin (BCG) vaccine (3 cases), interferon (18 cases), immune-checkpoint inhibitors (ICI) (19 cases), and biologic disease-modifying antirheumatic drugs (bDMARDs) (127 cases). Drugs causing psoriasis may also induce or aggravate PsA (6 cases). BDMARD-related PsA mostly occurred in a "paradoxical" setting, in which the bDMARDs approved for the treatment of psoriasis induce or aggravate PsA. The reported latency may be delayed up to 2 years. Peripheral arthritis (82.3%) was the most common manifestation of drug- and vaccine-related PsA, followed by dactylitis (29.1%), enthesitis (23.4%), and spondyloarthritis (17.7%).
CONCLUSIONS
Drugs and vaccines may be implicated in the aggravation of PsA. Possible mechanisms include cytokine imbalance, immune dysregulation, or inadequate PsA treatment response compared with psoriasis. Most reports are case based without controls, so more studies are needed to further prove the causality. However, early recognition of factors causing or aggravating PsA is important to prevent the irreversible joint damage.
PubMed: 38183617
DOI: 10.1007/s13555-023-01082-z -
BMC Bioinformatics Oct 2023Recent advancements in computing power and state-of-the-art algorithms have helped in more accessible and accurate diagnosis of numerous diseases. In addition, the...
BACKGROUND
Recent advancements in computing power and state-of-the-art algorithms have helped in more accessible and accurate diagnosis of numerous diseases. In addition, the development of de novo areas in imaging science, such as radiomics and radiogenomics, have been adding more to personalize healthcare to stratify patients better. These techniques associate imaging phenotypes with the related disease genes. Various imaging modalities have been used for years to diagnose breast cancer. Nonetheless, digital breast tomosynthesis (DBT), a state-of-the-art technique, has produced promising results comparatively. DBT, a 3D mammography, is replacing conventional 2D mammography rapidly. This technological advancement is key to AI algorithms for accurately interpreting medical images.
OBJECTIVE AND METHODS
This paper presents a comprehensive review of deep learning (DL), radiomics and radiogenomics in breast image analysis. This review focuses on DBT, its extracted synthetic mammography (SM), and full-field digital mammography (FFDM). Furthermore, this survey provides systematic knowledge about DL, radiomics, and radiogenomics for beginners and advanced-level researchers.
RESULTS
A total of 500 articles were identified, with 30 studies included as the set criteria. Parallel benchmarking of radiomics, radiogenomics, and DL models applied to the DBT images could allow clinicians and researchers alike to have greater awareness as they consider clinical deployment or development of new models. This review provides a comprehensive guide to understanding the current state of early breast cancer detection using DBT images.
CONCLUSION
Using this survey, investigators with various backgrounds can easily seek interdisciplinary science and new DL, radiomics, and radiogenomics directions towards DBT.
Topics: Humans; Female; Deep Learning; Radiographic Image Enhancement; Breast; Breast Neoplasms; Mammography
PubMed: 37884877
DOI: 10.1186/s12859-023-05515-6 -
Journal of Abdominal Wall Surgery : JAWS 2023To perform a systematic review and meta-analysis on the effectiveness of prophylactic mesh for the prevention of parastomal hernia in end colostomy, with the ultimate...
To perform a systematic review and meta-analysis on the effectiveness of prophylactic mesh for the prevention of parastomal hernia in end colostomy, with the ultimate objective to summarize the evidence for an interdisciplinary, European rapid guideline. We updated a previous systematic review with evidence search of PubMed from inception up to June 2022. Primary outcome was quality of life (QoL). Secondary outcomes were clinical diagnosis of parastomal hernia, surgery for parastomal hernia, and 30 day or in-hospital complications Clavien-Dindo ≥3. We utilised the revised Cochrane Tool for randomised trials (RoB 2 tool) for risk of bias assessment in the included studies. Minimally important differences were set through voting of the panel members. We appraised the evidence using GRADE and we developed GRADE evidence tables. We included 12 randomized trials. Meta-analysis suggested no difference in QoL between prophylactic mesh and no mesh for primary stoma construction (SMD = 0.03, 95% CI [-0.14 to 0.2], I = 0%, low certainty of evidence). With regard to parastomal hernia, the use of prophylactic synthetic mesh resulted in a significant risk reduction of the incidence of the event, according to data from all available randomized trials, irrespective of the follow-up period (OR = 0.33, 95% CI [0.18-0.62], I = 74%, moderate certainty of evidence). Sensitivity analyses according to follow-up period were in line with the primary analysis. Little to no difference in surgery for parastomal hernia was encountered after pooled analysis of 10 randomised trials (OR = 0.52, 95% CI [0.25-1.09], I = 14%). Finally, no significant difference was found in Clavien-Dindo grade 3 and 4 adverse events after surgery with or without the use of a prophylactic mesh (OR = 0.77, 95% CI [0.45-1.30], I = 0%, low certainty of evidence). Prophylactic synthetic mesh placement at the time of permanent end colostomy construction is likely associated with a reduced risk for parastomal hernia and may confer similar risk of peri-operative major morbidity compared to no mesh placement. There may be no difference in quality of life and surgical repair of parastomal hernia with the use of either approach.
PubMed: 38312423
DOI: 10.3389/jaws.2023.11550 -
Cancers Nov 2023Radiation-induced soft tissue sarcomas (RISs) are rare secondary malignancies with a dire prognosis. The literature on the management of these tumors remains scarce due... (Review)
Review
INTRODUCTION
Radiation-induced soft tissue sarcomas (RISs) are rare secondary malignancies with a dire prognosis. The literature on the management of these tumors remains scarce due to their low incidence. Our systematic review sought to assess the treatment alternatives and outcomes of patients with RIS.
METHODS
A systematic review was conducted following the PRISMA guidelines. Our study was registered in PROSPERO (ID: CRD42023438415). Quality assessment was performed using the STROBE checklist. Weighted means for both continuous and categorical values were calculated.
RESULTS
Twenty-one studies comprising 1371 patients with RIS were included. The mean latency period from radiation to RIS diagnosis was 14 years, and the mean radiation dose delivered to the primary malignancy was 29.2 Gy. The most common histological type was undifferentiated pleomorphic sarcoma (42.2%), and 64% of all tumors were high-grade. The trunk was the most common location (59%), followed by extremities (21%) and pelvis (11%). Surgery was performed in 68% of patients and, among those with an appendicular tumor, the majority (74%) underwent limb-salvage surgery. Negative margins were attained in 58% of patients. Chemotherapy and radiotherapy were administered in 29% and 15% of patients, respectively. The mean 5-year overall survival was 45%, and the local recurrence and metastasis rates were 39% and 27%, respectively.
CONCLUSIONS
In our study, the most common treatment was surgical resection, with RT and chemotherapy being administered in less than one third of patients. Patients with RIS exhibited poor oncologic outcomes. Future studies should compare RIS with de novo STS while controlling for confounders.
PubMed: 38067287
DOI: 10.3390/cancers15235584 -
PharmacoEconomics Jul 2023The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Eli Lilly) of abemaciclib (Verzenios) to submit evidence for the clinical and cost... (Review)
Review
Abemaciclib in Combination with Endocrine Therapy for Adjuvant Treatment of Hormone Receptor-Positive, HER2-Negative, Node-Positive Early Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.
The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Eli Lilly) of abemaciclib (Verzenios) to submit evidence for the clinical and cost effectiveness of this drug in combination with endocrine therapy (ET) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence, as part of the Institute's Single Technology Appraisal (STA) process. Kleijnen Systematic Reviews Ltd, in combination with Newcastle University, was commissioned to act as the independent Evidence Review Group (ERG). This paper summarised the Company Submission (CS), presents the ERG's critical review of the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations, and describes the development of the NICE guidance by the Appraisal Committee. The ERG produced a critical review of the evidence for the clinical and cost-effectiveness evidence in the CS and also independently searched for relevant evidence and modified the manufacturer decision analytic model to examine the impact of altering some of the key assumptions. A systematic literature review identified the MonarchE trial, an ongoing, open-label, randomised, double blind trial involving 5637 people comparing abemaciclib in combination with ET versus ET alone. The trial included two cohorts that used different inclusion criteria to define high risk of recurrence. The ERG considered Cohort 1 as an adequate representation of this population and the AC concluded that Cohort 1 was generalisable to National Health Service clinical practice. Trial results showed improvements in invasive disease-free survival for the abemaciclib arm, which was considered an appropriate surrogate outcome. The ERG believed that the modelling structure presented in the de novo economic model by the company was appropriate but highlighted several areas of uncertainty that had the potential to have a significant impact on the resulting incremental cost-effectiveness ratio (ICER). Areas of uncertainty included the extrapolation of long-term survival curves, the duration of treatment effect and treatment waning, and the proportion of patients who receive other CDK4/6 treatments for metastatic disease after receiving abemaciclib. ICER estimates were £9164 per quality-adjusted life-year gained for the company's base-case and £17,810 for the ERG's base-case. NICE recommended abemaciclib with ET as an option for the adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.
Topics: Adult; Humans; Female; Breast Neoplasms; State Medicine; Aminopyridines; Benzimidazoles; Adjuvants, Immunologic; Cost-Benefit Analysis; Technology Assessment, Biomedical; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic
PubMed: 36952138
DOI: 10.1007/s40273-023-01259-6 -
Journal of Cardiothoracic Surgery Nov 2023The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve... (Review)
Review
BACKGROUND
The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
METHODS
An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
RESULTS
Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average.
CONCLUSION
FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.
Topics: Humans; Mitral Valve; Prosthesis Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Bioprosthesis; Prosthesis Failure
PubMed: 38037117
DOI: 10.1186/s13019-023-02464-2