Joint EANM-SNMMI guideline on the role of 2-[18F]FDG PET/CT in no special type breast cancer : (endorsed by the ACR, ESSO, ESTRO, EUSOBI/ESR, and EUSOMA).

INTRODUCTION: There is much literature about the role of 2-[18F]FDG PET/CT in patients with breast cancer (BC). However, there exists no international guideline with involvement of the nuclear medicine societies about this subject. PURPOSE: To provide an organized, international, state-of-the-art, and multidisciplinary guideline, led by experts of two nuclear medicine societies (EANM and SNMMI) and representation of important societies in the field of BC (ACR, ESSO, ESTRO, EUSOBI/ESR, and EUSOMA). METHODS: Literature review and expert discussion were performed with the aim of collecting updated information regarding the role of 2-[18F]FDG PET/CT in patients with no special type (NST) BC and summarizing its indications according to scientific evidence. Recommendations were scored according to the National Institute for Health and Care Excellence (NICE) criteria. RESULTS: Quantitative PET features (SUV, MTV, TLG) are valuable prognostic parameters. In baseline staging, 2-[18F]FDG PET/CT plays a role from stage IIB through stage IV. When assessing response to therapy, 2-[18F]FDG PET/CT should be performed on certified scanners, and reported either according to PERCIST, EORTC PET, or EANM immunotherapy response criteria, as appropriate. 2-[18F]FDG PET/CT may be useful to assess early metabolic response, particularly in non-metastatic triple-negative and HER2+ tumours. 2-[18F]FDG PET/CT is useful to detect the site and extent of recurrence when conventional imaging methods are equivocal and when there is clinical and/or laboratorial suspicion of relapse. Recent developments are promising. CONCLUSION: 2-[18F]FDG PET/CT is extremely useful in BC management, as supported by extensive evidence of its utility compared to other imaging modalities in several clinical scenarios.

Surgical intervention for cerebral amyloid angiopathy-related lobar intracerebral hemorrhage: a systematic review.

OBJECTIVE: The risks and benefits of surgery for cerebral amyloid angiopathy (CAA)-related lobar intracerebral hemorrhage (ICH) are unclear. The aim of this study was to systematically review the literature on this topic. METHODS: The authors conducted a systematic review according to the 2020 PRISMA statement. PubMed, MEDLINE, Embase, Web of Science, Cochrane Library, Emcare, and Academic Search Premier were searched (on December 27, 2022) for relevant articles. Study inclusion criteria were: 1) randomized controlled trial (RCT), cohort study, cross-sectional design, or case series with more than 5 patients; 2) possible, probable, or definite CAA according to the Boston criteria (version 1.0 or 1.5) or autopsy; 3) surgical intervention for acute ICH; and 4) data on peri- and/or postoperative outcomes. Primary outcomes were the presence of intraoperative hemorrhage (IOH), postoperative hemorrhage (POH), and early ICH recurrence. Secondary outcomes were 3-month mortality, late ICH recurrence, functional outcome at discharge, and factors associated with poor outcome. Pooled estimates were calculated, and the Joanna Briggs Institute Critical Appraisal Tool was used to assess risk of bias. RESULTS: Four cohort studies and 15 case series (n = 738 patients, mean age 70 years, 56% women) were included. IOH occurred in 2 (0.6%) of 352 patients. Pooled estimates for POH were 13.0% (30/225) for less than 48 hours and 6.2% (3/437) for 48 hours to 14 days. Overall recurrent ICH (mean follow-up 19 months, n = 5 studies) occurred in 11% of patients. Outcome was predominantly poor with a pooled 3-month mortality rate of 19% and good outcome of 23%. Factors associated with poor outcome were advanced age, poor condition on admission, preexisting dementia, and concomitant intraventricular, subarachnoid, or subdural hemorrhage. All studies contained possible sources of bias and reporting was heterogeneous. CONCLUSIONS: Surgery in CAA-related ICH is safe with no substantial IOH, POH, and early recurrent hemorrhage risk. Outcome appears to be poor, however, especially in older patients, although good quality of evidence is lacking. Patients with CAA should not be excluded from ongoing surgery RCTs in ICH to enable future subgroup analysis of this specific patient population.

Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis.

OBJECTIVES: To obtain an overview of recent evidence on efficacy and safety of pharmacological treatments in psoriatic arthritis (PsA). METHODS: This systematic literature research (SLR) investigated the efficacy and safety of conventional synthetic (cs), biological (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in patients with PsA. A systematic database search using Medline, EMBASE, Cochrane CENTRAL was conducted to identify relevant articles published since the previous update in 2019 until 28 December 2022. Efficacy was assessed in trials while for safety observational data were also considered. Adverse events of special interest were infections (including herpes zoster, influenza and tuberculosis), malignancies, major adverse cardiovascular events, venous thromboembolisms, liver disease, laboratory changes and psychiatric adverse events. No meta-analyses were performed. RESULTS: For efficacy, of 3946 articles screened, 38 articles (30 trials) were analysed. The compounds investigated included csDMARDs (leflunomide, methotrexate), bDMARDs inhibiting IL17 (bimekizumab, brodalumab, ixekizumab, izokibep, secukinumab,), IL-23 (guselkumab, risankizumab, tildrakizumab), IL-12/23 (ustekinumab) as well as TNF (adalimumab, certolizumab-pegol, etanercept, infliximab, golimumab) and Janus Kinase inhibitors (JAKi) (brepocitinib, deucravacitinib, tofacitinib, upadacitinib). The compounds investigated were efficacious in improving signs and symptoms of PsA, improving physical functioning and quality of life. For safety, 2055 abstracts were screened, and 24 articles analysed: 15 observational studies and 9 long-term follow-ups of trials, assessing glucocorticoids, TNFi, IL-17i, JAKi, IL-12/23i and PDE4i (apremilast). Safety indicators were generally coherent with the previous SLR in 2019. CONCLUSION: The results of this SLR informed the task force responsible for the 2023 update of the European Alliance of Associations for Rheumatology recommendations for pharmacological management of PsA.

Noninvasive monitoring technologies to identify discomfort and distressing symptoms in persons with limited communication at the end of life: a scoping review.

BACKGROUND: Discomfort and distressing symptoms are common at the end of life, while people in this stage are often no longer able to express themselves. Technologies may aid clinicians in detecting and treating these symptoms to improve end-of-life care. This review provides an overview of noninvasive monitoring technologies that may be applied to persons with limited communication at the end of life to identify discomfort. METHODS: A systematic search was performed in nine databases, and experts were consulted. Manuscripts were included if they were written in English, Dutch, German, French, Japanese or Chinese, if the monitoring technology measured discomfort or distressing symptoms, was noninvasive, could be continuously administered for 4 hours and was potentially applicable for bed-ridden people. The screening was performed by two researchers independently. Information about the technology, its clinimetrics (validity, reliability, sensitivity, specificity, responsiveness), acceptability, and feasibility were extracted. RESULTS: Of the 3,414 identified manuscripts, 229 met the eligibility criteria. A variety of monitoring technologies were identified, including actigraphy, brain activity monitoring, electrocardiography, electrodermal activity monitoring, surface electromyography, incontinence sensors, multimodal systems, and noncontact monitoring systems. The main indicators of discomfort monitored by these technologies were sleep, level of consciousness, risk of pressure ulcers, urinary incontinence, agitation, and pain. For the end-of-life phase, brain activity monitors could be helpful and acceptable to monitor the level of consciousness during palliative sedation. However, no manuscripts have reported on the clinimetrics, feasibility, and acceptability of the other technologies for the end-of-life phase. CONCLUSIONS: Noninvasive monitoring technologies are available to measure common symptoms at the end of life. Future research should evaluate the quality of evidence provided by existing studies and investigate the feasibility, acceptability, and usefulness of these technologies in the end-of-life setting. Guidelines for studies on healthcare technologies should be better implemented and further developed.

Sporadic cerebral small vessel disease and cognitive decline in healthy older adults: A systematic review and meta-analysis.

We performed a systematic review and meta-analysis on prospective studies that provided risk estimates for the impact of 3 different MRI markers of small vessel disease (SVD), namely white matter hyperintensities (WMH), cerebral microbleeds (CMB) and lacunes, on cognitive decline in relatively healthy older adults without cognitive deficits at baseline. A total of 23 prospective studies comprising 11,486 participants were included for analysis. Extracted data was pooled, reviewed and meta-analysed separately for global cognition, executive function, memory and attention. The pooled effect size for the association between cerebral SVD and cognitive decline was for global cognition -0.10 [-0.14; -0.05], for executive functioning -0.18 [-0.24; - 0.11], for memory -0.12 [-0.17; -0.07], and for attention -0.17 [-0.23; -0.11]. Results for the association of individual MRI markers of cerebral SVD were statistically significant for WMH and global cognition -0.15 [-0.24; -0.06], WMH and executive function -0.23 [-0.33; -0.13], WMH and memory -0.19 [-0.29; -0.09], WMH and attention -0.24 [-0.39; -0.08], CMB and executive function -0.07 [-0.13; -0.02], CMB and memory -0.11 [-0.21; -0.02] and CMB and attention -0.13 [-0.25; -0.02]. In conclusion, presence of MRI markers of cerebral SVD were found to predict an increased risk of cognitive decline in relatively healthy older adults. While WMH were found to significantly affect all cognitive domains, CMB influenced decline in executive functioning over time as well as (in some studies) decline in memory and attention.

Global Guidelines in Dermatology Mapping Project (GUIDEMAP)-A systematic review of the methodological quality of contact dermatitis clinical practice guidelines.

The Global Guidelines in Dermatology Mapping Project (GUIDEMAP) assesses the methodological quality of clinical practice guidelines (CPGs) for high-burden skin diseases. This review focuses on contact dermatitis. We searched MEDLINE, Embase, PubMed, Web of Science, Cochrane Library, Emcare, Epistemonikos, PsycINFO and Academic Search Premier for CPGs published between 1 November 2018 and 1 November 2023. Prespecified guideline resources were hand searched. Two authors independently undertook screening, data extraction and quality assessments. Instruments used were the Appraisal of Guidelines for Research and Evaluation (AGREE) II Reporting Checklist, the U.S. Institute of Medicine's (IOM) criteria of trustworthiness, The Agency for Healthcare Research and Quality's National Guideline Clearinghouse Extent Adherence to Trustworthy Standards (NEATS) Instrument and Lenzer's Red Flags. Twenty five CPGs were included, exhibiting heterogeneity in both the topics they addressed and their methodological quality. Whereas the CPGs on management of hand eczema from Denmark, Europe and the Netherlands scored best, most CPGs fell short of being clear, unbiased, trustworthy and evidence-based. Disclosure of conflicts of interest scored well, and areas needing improvement include 'strength and wording of recommendations', 'applicability', 'updating' and 'external review'. Adhering to AGREE II and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) enhances methodological quality.

The relevance of the superior cervical ganglion for cardiac autonomic innervation in health and disease: a systematic review.

PURPOSE: The heart receives cervical and thoracic sympathetic contributions. Although the stellate ganglion is considered the main contributor to cardiac sympathetic innervation, the superior cervical ganglia (SCG) is used in many experimental studies. The clinical relevance of the SCG to cardiac innervation is controversial. We investigated current morphological and functional evidence as well as controversies on the contribution of the SCG to cardiac innervation. METHODS: A systematic literature review was conducted in PubMed, Embase, Web of Science, and COCHRANE Library. Included studies received a full/text review and quality appraisal. RESULTS: Seventy-six eligible studies performed between 1976 and 2023 were identified. In all species studied, morphological evidence of direct or indirect SCG contribution to cardiac innervation was found, but its contribution was limited. Morphologically, SCG sidedness may be relevant. There is indirect functional evidence that the SCG contributes to cardiac innervation as shown by its involvement in sympathetic overdrive reactions in cardiac disease states. A direct functional contribution was not found. Functional data on SCG sidedness was largely unavailable. Information about sex differences and pre- and postnatal differences was lacking. CONCLUSION: Current literature mainly supports an indirect involvement of the SCG in cardiac innervation, via other structures and plexuses or via sympathetic overdrive in response to cardiac diseases. Morphological evidence of a direct involvement was found, but its contribution seems limited. The relevance of SCG sidedness, sex, and developmental stage in health and disease remains unclear and warrants further exploration.

A systematic literature review of randomised controlled trials evaluating colchicine for cardiovascular prevention: There is an elephant in the room.

OBJECTIVES: To review randomised controlled trials (RCT) investigating colchicine (COL) for cardiovascular (CV) prevention in patients at high to very high CV risk aiming to extract data that could be useful in rheumatology practice. METHODS: A systematic search of multiple databases according to the PICO framework was performed from inception to April 3, 2023. Three researchers independently screened abstracts/titles and reviewed full texts reviewed. Data extraction was performed using a pilot-tested data extraction form. RESULTS: A total of 14,096 references were retrieved by the search and 30 articles, describing 28 RCTs, were included in the review (Total number of patients 16,795, of which 8,463 randomised to COL; dose 0.5-2 mg/day, treatment duration 1day-29 months). Only one of the 28 RCTs provided clear information on whether patients with rheumatic diseases (more specifically gout) were enrolled in the study cohorts and previous use of COL was an exclusion criterion only in 14 (50 %) RCTs. Previous therapy with glucocorticoids and/or non-steroidal anti-inflammatory drugs and/or immune suppressive therapies was an exclusion criterion only in 9 (32 %) RCTs. CONCLUSION: Our results highlight the need to redefine the eligibility criteria as well as the reporting of results in future RCTs in order to minimise bias or previous exposure to COL and also obtain data that could be useful in rheumatology practice.

Biomarkers to discriminate between aseptic loosened and stable total hip or knee arthroplasties: a systematic review.

Background: Loosening is a major cause for failure of total hip and total knee arthroplasties (THAs/TKAs). Preemptive diagnostics of asymptomatic loosening could open strategies to prevent gross loosening. A multitude of biomarkers may discriminate between loosened and stable implants, but it is unknown which have the best performance. The present systematic review aimed to assess which biomarkers have shown the most promising results in discriminating between stable and aseptic loosened THAs and TKAs. Methods: PubMed, Embase, Web of Science, Cochrane Library, and Academic Search Premier were systematically searched up to January 2020 for studies including THA/TKA and biomarkers to assess loosening. Two reviewers independently screened records, extracted data, and assessed the risk of bias using the ICROMS tool to classify the quality of the studies. Results: Twenty-eight (three high-quality) studies were included, reporting on a median of 48 patients (interquartile range 28-69). Serum and urine markers were evaluated in 22 and 10 studies, respectively. Tumor necrosis factor α and osteocalcin were significantly higher in loosened compared with stable implants. Urinary N-terminal telopeptide had significantly elevated levels in loosened prostheses. Conclusion: Several serum and urine markers were promising in discriminating between loosened and stable implants. We recommend future studies to evaluate these biomarkers in a longitudinal fashion to assess whether progression of loosening is associated with a change in these biomarkers. In particular, high-quality studies assessing the usability of these biomarkers are needed.

European guidelines for the diagnosis, treatment and follow-up of breast lesions with uncertain malignant potential (B3 lesions) developed jointly by EUSOMA, EUSOBI, ESP (BWG) and ESSO.

INTRODUCTION: Breast lesions of uncertain malignant potential (B3) include atypical ductal and lobular hyperplasias, lobular carcinoma in situ, flat epithelial atypia, papillary lesions, radial scars and fibroepithelial lesions as well as other rare miscellaneous lesions. They are challenging to categorise histologically, requiring specialist training and multidisciplinary input. They may coexist with in situ or invasive breast cancer (BC) and increase the risk of subsequent BC development. Management should focus on adequate classification and management whilst avoiding overtreatment. The aim of these guidelines is to provide updated information regarding the diagnosis and management of B3 lesions, according to updated literature review evidence. METHODS: These guidelines provide practical recommendations which can be applied in clinical practice which include recommendation grade and level of evidence. All sections were written according to an updated literature review and discussed at a consensus meeting. Critical appraisal by the expert writing committee adhered to the 23 items in the international Appraisal of Guidelines, Research and Evaluation (AGREE) tool. RESULTS: Recommendations for further management after core-needle biopsy (CNB) or vacuum-assisted biopsy (VAB) diagnosis of a B3 lesion reported in this guideline, vary depending on the presence of atypia, size of lesion, sampling size, and patient preferences. After CNB or VAB, the option of vacuum-assisted excision or surgical excision should be evaluated by a multidisciplinary team and shared decision-making with the patient is crucial for personalizing further treatment. De-escalation of surgical intervention for B3 breast lesions is ongoing, and the inclusion of vacuum-assisted excision (VAE) will decrease the need for surgical intervention in further approaches. Communication with patients may be different according to histological diagnosis, presence or absence of atypia, or risk of upgrade due to discordant imaging. Written information resources to help patients understand these issues alongside with verbal communication is recommended. Lifestyle interventions have a significant impact on BC incidence so lifestyle interventions need to be suggested to women at increased BC risk as a result of a diagnosis of a B3 lesion. CONCLUSIONS: These guidelines provide a state-of-the-art overview of the diagnosis, management and prognosis of B3 lesions in modern multidisciplinary breast practice.

Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis.

To describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). We performed a systematic review, searching eight databases up to February 2023. Randomized controlled trials (RCTs) evaluating supervised exercises in adults with RA or axSpA were considered eligible. Data on harms were extracted according to the CONSORT Harms 2022 Checklist. Among others, it was recorded if harms were prespecified or non-prespecified. Moreover, the nature of reported harms was listed. Forty RCTs were included for RA and 25 for axSpA, of which 29 (73%) and 13 (52%) reported information on harms. In 13 (33%) RCTs in RA and four (16%) in axSpA, the collection of harms outcomes was described in the methods section. Prespecified outcomes were reported by eight (RA) and two (axSpA) RCTs. Non-specified harms outcomes were reported by six (RA) and four (axSpA) RCTs. Prespecified harms outcomes included measures of pain, disease activity, inflammation, and structural joint changes. The nature of non-prespecified harms outcomes varied largely, with pain being most common. A considerable proportion of trials on supervised exercise in RA or axSpA does not or inadequately report harms outcomes. Pain was the most commonly reported prespecified or non-specified harm. For a considerate interpretation of the balance between benefits and harms of supervised exercise in RA or axSpA, use of the CONSORT Harms 2022 Checklist for the design, conduct and reporting of trials is advocated.

Oral Anticoagulation Versus Antiplatelet Treatment After Mitral Valve Repair: A Systematic Review and Meta-Analysis.

Oral anticoagulation with vitamin K antagonists is currently advised for a period of 3 months after surgical mitral valve repair, regardless of the rhythm status. The evidence supporting this recommendation is weak and recent studies have challenged the safety and efficacy of this recommendation. A systematic review of literature was conducted by searching PubMed, Embase, Web of Science, Emcare, and Cochrane Library databases for original publications comparing the efficacy and safety of oral anticoagulation with vitamin K antagonists to antiplatelet treatment early after mitral valve surgery in patients with no atrial fibrillation. Study end points included thromboembolic complications, bleeding complications and survival. A total of 5 studies, including 5,093 patients, met the inclusion criteria; 2,824 patients were included in the oral anticoagulation and 2,269 in the antiplatelet treatment group. Pooled analyses demonstrated no beneficial effect of oral anticoagulation on the incidence of thromboembolic complications (risk ratio 1.14, 95% confidence interval 0.76 to 1.70, p = 0.53, I2 = 8%). Moreover, oral anticoagulation did not result in a significantly increased risk of bleeding complications (risk ratio 0.89, 95% confidence interval 0.32 to 2.44, p = 0.81, I2 = 87%). When combining the efficacy and safety end points, no difference was observed between groups (risk ratio 1.01, 95% confidence interval 0.51 to 1.97, p = 0.99 I2 = 85%). Likewise, mortality did not differ between groups (risk ratio 0.89, 95% confidence interval 0.15 to 5.23, p = 0.90 I2 = 71%). Our results confirmed the safety but failed to confirm the efficacy of oral anticoagulation in patients who underwent mitral valve surgery. A randomized controlled trial would provide the evidence needed to support treatment recommendations.

Ten technical aspects of baseplate fixation in reverse total shoulder arthroplasty for patients without glenoid bone loss: a systematic review.

The aim of this systematic review was to collect evidence on the following 10 technical aspects of glenoid baseplate fixation in reverse total shoulder arthroplasty (rTSA): screw insertion angles; screw orientation; screw quantity; screw length; screw type; baseplate tilt; baseplate position; baseplate version and rotation; baseplate design; and anatomical safe zones. Five literature libraries were searched for eligible clinical, cadaver, biomechanical, virtual planning, and finite element analysis studies. Studies including patients >16 years old in which at least one of the ten abovementioned technical aspects was assessed were suitable for analysis. We excluded studies of patients with: glenoid bone loss; bony increased offset-reversed shoulder arthroplasty; rTSA with bone grafts; and augmented baseplates. Quality assessment was performed for each included study. Sixty-two studies were included, of which 41 were experimental studies (13 cadaver, 10 virtual planning, 11 biomechanical, and 7 finite element studies) and 21 were clinical studies (12 retrospective cohorts and 9 case-control studies). Overall, the quality of included studies was moderate or high. The majority of studies agreed upon the use of a divergent screw fixation pattern, fixation with four screws (to reduce micromotions), and inferior positioning in neutral or anteversion. A general consensus was not reached on the other technical aspects. Most surgical aspects of baseplate fixation can be decided without affecting fixation strength. There is not a single strategy that provides the best outcome. Therefore, guidelines should cover multiple surgical options that can achieve adequate baseplate fixation.

Harmful communication behaviors in cancer care: A systematic review of patients and family caregivers perspectives.

OBJECTIVE: Issues regarding clinician communication remain an important source of complaints within healthcare. This systematic review aims to determine cancer patients' and their family caregivers' views on which clinicians' communication behaviors can harm (i.e. eliciting negative feelings/consequences for patients/family caregivers). METHODS: We searched for all types of peer-reviewed studies that determined adult (≥18 years) cancer patients' and/or family caregivers' perspectives on which clinicians' communication behaviors can harm in several databases (PubMed, Embase, Web of Science, Cochrane Library, Emcare, PsycINFO and Academic Search Premier), supplemented by expert-consultation. Studies were screened using the Artificial intelligence screening tool of ASReview and data was analyzed using Thematic Analysis. To assess the quality of the studies the Qualsyst critical appraisal tool was used. RESULTS: A total of 47 studies were included. Four main themes of harmful communication behaviors were identified: (1) Lack of tailored information provision (e.g. giving too little or too much/specific information) (2) Lack of tailored decision making (ranging from; patient exclusion, to the patients' responsibility, and/or haste) (3) Lack of feeling seen and heard (seen as a disease, not as a human being; not listened to concerns and emotions) (4) Lack of feeling held and remembered (forgotten agreements; lack of care continuity). CONCLUSIONS: Our results reveal an overview of patients' and family caregivers' perspectives on which clinicians' communication behaviors can harm. Harm could be prevented when information and decision involvement are tailored and patients' and family caregivers' needs to feel seen, heard, held and remembered are met.

Smartphone-Based Passive Sensing in Monitoring Patients With Cancer: A Systematic Review.

PURPOSE: Patients with cancer are prone to frequent unplanned hospital visits because of disease or treatment complications. Smartphone-based passive sensing (SBPS) comprises data collection using smartphone sensors or device usage patterns, which may be an affordable and burdenless technique for remote monitoring of patients with cancer and timely detection of safety events. The aim of this article was to systematically review the published literature to identify the current state of SBPS in oncology care and research. METHODS: A literature search was done with cutoff date July 29, 2022, using six different databases. Articles were included if they reported original studies using SBPS in patients with cancer or cancer survivors. Data extracted from studies included type of sensors used, cancer type, study objectives, and main findings. RESULTS: Twelve studies were included, the oldest report being from 2017. The most frequent of the nine analyzed sensors and smartphone analytics was the accelerometer (eight studies) and geolocation (eight studies), followed by call logs (two studies). Breast cancer was the most studied cancer type (eight studies with 111 patients), followed by GI cancers (six studies with 133 patients). All studies aiming for feasibility concluded that SBPS in oncology was feasible (seven studies). SBPS was used as a monitoring tool, with passively sensed data being correlated with adverse events, symptom burden, cancer-related fatigue, decision conflict, recovery trends after surgery, or psychosocial impact. SBPS was also used in one study as a predictive tool for health deterioration. CONCLUSION: SBPS shows early promise in oncology, although it cannot yet replace traditional tools to monitor quality of life and clinical outcomes. For this, validation of SBPS will be required. Therefore, further research is warranted with this developing technique.

Untangling the relationship between bempedoic acid and gout: results from a systematic literature review.

Background: Bempedoic acid (BA) is a small-molecule first-in-class of inhibitor of ATP citrate lyase that significantly lowers low-density lipoproteins cholesterol (LDL-c) in statin-intolerant and inadequate responders. Increased serum uric acid (SUA) levels and gout incidence have been described in BA-treated patients. The aim of this systematic review was to investigate the safety of BA regarding SUA levels and gout in randomised controlled trials (RCTs). Methods: A search on 7 databases was performed from inception to May 4, 2023. RCTs of BA monotherapy or combination with other lipid-lowering treatment (LLT) in patients with increased LDL-c were included. Dual data extraction was performed with disagreements resolved through consensus. Due to the methodological purpose of this review risk-of-bias assessment of studies was not performed. Results: 6 Phase 3 RCTs (N = 17,975 patients of which 9,635 received BA) 9 Phase 2 RCTs (N = 362 patients of which 170 received BA) and an open-label extension of a Phase 3 RCT were included. Gout and/or hyperuricemia were not mentioned as exclusion criteria, previous/current use of urate-lowering therapies (ULT) and/or colchicine and/or dietary patterns were not reported. Phase 3 RCTs: 2 studies specified the number of patients experiencing hyperuricemia over the study period (BA: 4.9%-11%; placebo: 1.9%-5.6%) and the effect size was significant only in 1 study (OR = 2.0, 95% CI 1.8-2.3). Four RCTs reported a higher incidence of gout in the BA arm however, when we calculated the effect size, it was small and often not significant. Two studies reported 0 cases of gout. The paucity of information about SUA levels at baseline and/or at the end of follow-up do not allow us to quantify the effect sizes for BA-induced SUA elevation. Data on gout from Phase 2 RCTs is scant. Conclusions: Data from phase 2 and 3 RCTs do not allow for confirming a clear association between BA and gout. It is conceivable that a careful assessment of SUA levels/history of gout at baseline and the concomitant use of urate-lowering agents may be instrumental to minimise the risk of new-onset gout/gout flares in patients treated with BA.

Surgical management of digital ulcers in systemic sclerosis: A systematic literature review.

BACKGROUND: There is a strong rationale to develop locally-acting surgical treatments for digital ulcers (DUs) in patients with systemic sclerosis (SSc). Our aim was to examine the safety and efficacy of local surgical management for SSc-DU. METHODS: A systematic literature review was carried out until to August 2022 using 7 different databases. Original research studies concerning adult patients with SSc-DUs, and local surgical treatments were analysed using the PICO framework. We included randomized controlled trials, prospective/retrospective studies, and case series (minimum of 3 patients) References were independently screened by two reviewers including assessment of the risk of bias using validated tools. RESULTS: Out of 899, 13eligible articles were included. Autologous fat (adipose tissue AT) grafting was the surgical modality most identified (7 studies, 1 randomized controlled double blinded trial and 6 prospective open-label single arm studies). The healing rate (HR) with autologous fat grafting (4 studies) was 66-100 %. Three studies reported autologous adipose-derived stromal vascular fraction grafting: HR of 32-60 %. Bone marrow derived cell transplantation in a single study showed 100 % healing rate over 4-24 weeks. Surgical sympathectomy was examined in 3 studies, prospective without comparator with a median healing rate of 81 %. Two surgical studies (of direct microsurgical revascularisation and microsurgical arteriolysis) showed 100 % healing of ulcers, with no complications. CONCLUSION: Several surgical approaches for SSc-DUs have demonstrated some degree of safety and effectiveness for DU healing. However, there are significant methodological issues. Future studies are warranted to rigorously investigate surgical interventions for SSc-DUs.

Non-surgical local treatments of digital ulcers in systemic sclerosis: a systematic literature review.

INTRODUCTION: Digital ulcers (DUs) are difficult to treat in patients with systemic sclerosis (SSc) and systemic (i.e., pharmacological) therapy is currently considered the 'standard of care'. Our aim was to examine the safety and efficacy of local, non-surgical treatment for SSc-DUs. METHODS: A systematic literature review (SLR) of original research articles up to August, 29 2022 was performed according to the PICO framework. References were independently screened by two reviewers and risk of bias was assed using validated tools. Due to study heterogeneity narrative summaries are used to present data. RESULTS: Among 899 retrieved references, 14 articles were included (2 randomised trials (RTs), and 12 observational (OBS) studies). The most frequently studied procedure (5 studies) was botulin A toxin (hand or single finger) injection with a reported healing rate (HR) of 71%-100%. Amniotic and hydrocolloid membranes were examined in one study each and associated with a good HR. Tadalafil 2% cream was studied in a single study with a reduction in the number of DUs. Vitamin E gel was associated with a reduction in ulcer healing time. Low-level light therapy, hydrodissection and corticosteroid injection, extracorporeal shock wave (ESW) and photobiomodulation were evaluated in a single study each and showed a positive trend. Dimethyl sulfoxide was associated with significant local toxicity. CONCLUSIONS: A range of non-surgical, local treatments for SSc-DUs have been explored and showed efficacy to some extent. We have identified methodological flaws that should be avoided in the design of future studies to explore locally-acting treatments for SSc-DUs.