IIB or not IIB, part 2: assessing inter-rater and intra-rater repeatability of the Kenney–Doig scale in equine endometrial biopsy evaluation

Inter- and intra-rater variability negatively affects the reliability of various histopathology grading scales used as prognostic aids in human and veterinary medicine. The Kenney–Doig categorization (grading) scale, which is used to associate equine endometrial histologic lesions with prognostic estimation of a broodmare’s reproductive potential, has not been evaluated for inter- or intra-rater variability, to our knowledge. To assess whether the Kenney–Doig system produces reliable results among observers, 8 pathologists, all with American College of Veterinary Pathologists certification, were recruited to blindly categorize the same set of 63 digital equine endometrial biopsy slides as well as to re-evaluate anonymously 21 of 63 of these slides at a later time. Cohen kappa values for pairwise comparison of final Kenney–Doig categories were −0.05 to 0.46 (unweighted) and 0.08–0.64 (weighted), with an average Light kappa of 0.19 (unweighted) and 0.36 (weighted) across all 8 pathologists, 0.14 (unweighted) and 0.33 (weighted) for pathologists at different institutions, and 0.22 (unweighted) and 0.46 (weighted) for pathologists at the same institution. Intra-class correlations measuring intra-rater agreement were 0.12–0.77 with an average of 0.55 for all 8 pathologists. We found that only slight-to-moderate inter-rater agreement and poor-to-good intra-rater agreement was produced by 8 pathologists using the Kenney–Doig scale, suggesting that the system is subject to significant observer variability and care should be taken when communicating Kenney–Doig categories to submitting clinicians with emphasis on the quality of endometrial lesions present instead of the category and associated expected foaling rate.

Technical Success and Mid-Term Outcomes of Endovascular Revascularization of Tibio-Peroneal Trunk Lesions

Tibio-peroneal trunk (TPT) lesions are usually categorized as ‘complex’ in anatomical classifications, which leads to the perception that endovascular therapy (EVT) will be challenging and the outcome most likely poor. This multicenter, retrospective cohort study investigates the efficacy of the EVT of TPT lesions in patients with chronic limb threatening ischemia (CLTI) or an infrapopliteal bypass at risk. The primary endpoint was limb-salvage. The secondary outcomes were technical success, freedom from clinically driven target lesion revascularization (CD-TLR), overall survival, and amputation-free survival. A total of 107 TPT lesions were treated in 101 patients. At 3 years, the limb-salvage rate was 76.4% (95% CI 66.0–86.8%). Technical success was achieved in 96.3% of cases. The freedom from CD-TLR, amputation-free survival, and overall survival at 3 years were 53.0% (95% CI 38.1–67.9%), 33.6% (95% CI 23.0–44.2%), and 47.7% (95% CI 36.1–59.3%), respectively. Reintervention significantly increased the hazard ratio for amputation by 7.65 (95% CI 2.50–23.44, p < 0.001). Our results show that the EVT of both isolated and complex TPT lesions is associated with high technical success and acceptable limb-salvage rates, with reintervention being a major risk factor for amputation. Moreover, mid-term mortality rate was relatively high. In future revisions of the anatomical grading scales, the classification of TPT lesions as highly complex should be reconsidered.

Role of ultrasound and magnetic resonance imaging in the prognosis and classification of muscle injuries in professional football players: correlation between imaging and return to sport time

Purpose To study distractive muscle injuries applying US and MRI specific classifications and to find if any correlation exists between the results and the return to sport (RTS) time. The second purpose is to evaluate which classification has the best prognostic value and if the lesions extension correlates with the RTS time. Methods A total of 26 male, professional soccer players (age 21.3 ± 5.6), diagnosed with traumatic muscle injury of the lower limbs, received ultrasound and MRI evaluation within 2 days from the trauma. Concordance between US and MRI findings was investigated. The relationships between MRI and US based injury grading scales and RTS time were evaluated. Correlation between injuries’ longitudinal extension and RTS time was also investigated. Results The correlation between US and MRI measurements returned a Spearman value of rs = 0.61 (p = .001). Peetrons and Mueller-Wohlfahrt grading scales correlations with RTS time were r = 0.43 (p = .02) and r = 0.83 (p = < .001). The lesion’s extension correlation with RTS time was r = 0.63 (p < .001). The correlation between the site of the lesion and its location with the RTS time were rs = 0.2 and rs = 0.25. Conclusions Both US and MRI can be used as prognostic indicators along with the Peetrons (US) and the Mueller-Wohlfahrt (MRI) classifications. MRI is more precise and generates more reproducible results. The lesion craniocaudal extension must be considered as a prognostic indicator, while the injury location inside the muscle or along its major axis has doubtful significance.

Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project

Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety and tolerances of vaccinations with BNT162b2 performed in chronically dialyzed patients. Materials and Methods: We performed a prospective cohort study including a group of 190 dialyzed patients (65% male) at median age 68.0 (55–74) years. 169 (89.0%) patients were treated with hemodialysis and 21 (11.0%) with peritoneal dialysis. The control group consisted of 160 people (61% male) without chronic kidney disease at median age 63 (range 53–77) years. Both groups were vaccinated with BNT162b2 with a 21-day interval between the first and the second dose. Solicited local and systemic reactogenicity, unsolicited adverse events and antipyretic and pain medication use were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA Center for Biologics Evaluation and Research guidelines. Results: 59.8% (dose 1), 61.4% (dose 2) and 15.9% (dose 1), 29.4% (dose 2) dialyzed patients reported at least one local and one systemic reaction respectively within seven days after the vaccination. Many local and systemic solicited reactions were observed less frequently in dialyzed patients than in the age and sex matched control group and much less frequently than reported in the pivotal study. They were mostly mild to moderate, short-lived, and more frequently reported in younger individuals and women. No related unsolicited adverse events were observed. Conclusions: We have shown here that BNT162b2, an mRNA vaccine from Pfizer-BioNTech against SARS-COV-2 is safe and well-tolerated by dialyzed patients. The results can be useful for the nephrological community to resolve patients’ doubts and reduce their vaccine hesitancy.