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.@en

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.@en

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.@en

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.@en

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.@en

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.@en

In order to improve care for total hip and knee arthroplasties (THA/TKA), hospitals may want to compare their performance with hospitals in other countries. Pooling data across countries also enable early detection of infrequently occurring safety issues. We therefore aimed to assess the between-hospital variation and definitions used for revision, readmission, and complications across countries. • PubMed, Embase, Web of Science, Cochrane library, Emcare, and Academic Search Premier were searched from January 2009 to August 2020 for studies reporting on: (i) primary THA/ TKA; (ii) revision, readmission, or complications; and (iii) between-hospital variation. Most recent registry reports of Network of Orthopedic Registries of Europe members were also reviewed. Two reviewers independently screened records, extracted data, and assessed the risk of bias using the Integrated quality Criteria for the Review Of Multiple Study designs tool for studies and relevant domains for registries. We assessed agreement for the following domains: (i) outcome definition; (ii) follow-up and starting point; (iii) case-mix adjustment; and (iv) type of patients and hospitals included. • Between-hospital variation was reported in 33 (1 high-quality, 13 moderate-quality, and 19 low-quality) studies and 8 registry reports. The range of variation for revision was 0-33% for THA and 0-27% for TKA varying between assessment within hospital admission until 10 years of follow-up; for readmission, 0-40% and 0-32% for THA and TKA, respectively; and for complications, 0-75% and 0-50% for THA and TKA, respectively. Indicator definitions and methodological variables varied considerably across domains. • The large heterogeneity in definitions and methods used likely explains the considerable variation in between-hospital variation reported for revision, readmission, and complications, making it impossible to benchmark hospitals across countries or pool data for earlier detection of safety issues. It is necessary to collaborate internationally and strive for more uniformity in indicator definitions and methods in order to achieve reliable international benchmarking in the future.@en

Background: Scapular winging is a rare condition of the shoulder girdle that presents challenging treatment decisions for clinicians. To inform clinical practice, clinicians need guidance on what the best treatment decision is for their patients, and such recommendations should be based on the total evidence available. Therefore, the purpose of this review was to systematically review the evidence regarding nonsurgical management and tendon transfer surgery of patients with neurologic scapular winging due to serratus anterior (SA) or trapezius (TP) palsy. Methods: PubMed, Embase, Web of Science, Cochrane Library, Emcare, and Academic Search Premier were searched up to April 5, 2022, for studies reporting on clinical outcomes after nonsurgical management and tendon transfer surgery of scapular winging due to weakness of the SA or TP muscle. The Integrated quality Criteria for Review Of Multiple Study (ICROMS) tool was used to classify the quality of the studies. Primary outcomes were the fraction of patients with spontaneous recovery after nonsurgical management and improvement in shoulder function, pain scores, and shoulder scores after tendon transfer surgery. Data were pooled if data on the same outcome were available for at least 3 studies, using random-effects meta-analysis. Results: Twenty-three (10 moderate-quality [MQ] and 13 low-quality) studies were included. Six studies (3 MQ; 234 shoulders) reported on outcomes after nonsurgical management of SA palsy, whereas 12 (6 MQ; 221 shoulders) and 6 studies (1 MQ; 80 shoulders) evaluated the outcomes of tendon transfer for SA or TP palsy (1 study addressed both). Spontaneous recovery of scapular winging with nonsurgical management varied between 21% and 78% across studies after a median follow-up of 72 months. For surgical management of SA palsy, pooling data in a meta-analysis showed that patients on average improved by 47° (95% confidence interval [CI]: 34-61, P ≤ .001) in active forward flexion, had lower visual analog scale scores for pain (mean difference [MD]: −3.0, 95% CI: −4.9 to −1.0, P = .003), and had substantial improvements in American Shoulder and Elbow Surgeons (MD: 24, 95% CI: 9-39, P = .002) and Constant scores (MD: 45, 95% CI: 39-51, P ≤ .001). Patients with TP palsy on average improved by 36° (95% CI: 21-51, P ≤ .001) in active forward flexion after tendon transfer. Statistical pooling was not possible for other outcome measures as insufficient data were available. Conclusion: A substantial part of nonsurgically managed patients with scapular winging seem to have persistent complaints, which should be part of the information provided to patients. Data pooling demonstrated significant improvements in shoulder function, pain scores, and shoulder scores after tendon transfer surgery, but higher quality evidence is needed to allow for more robust recommendations and guide clinical decision-making on when to perform such functional surgery.@en