Ultrafast intraoperative parathyroid hormone monitoring system: prospective, multicentre, clinical validity study.

BACKGROUND: Intraoperative parathyroid hormone (PTH) monitoring is a proven and reliable adjunct to parathyroid surgery, able to improve the outcomes and efficiency of the diagnostic and therapeutic pathway for patients with primary hyperparathyroidism. This study evaluated the innovative, compact, fully automated NBCL CONNECT Analyzer, which can measure whole-blood PTH in 5 min. METHODS: A prospective multicentre study was conducted in stages: results reviews, recommendations, and implementation of improvements to the mechanical design, components of cartridges, calibration, and sampling protocols. Patients undergoing parathyroidectomy had PTH levels measured on the Analyzer and main laboratory platforms, either Roche or Abbott. The Miami criterion of a 50% drop in PTH concentration was used to define biochemical cure during surgery, and normal postoperative calcium level as cure of primary hyperparathyroidism. Measurements on the Analyzer were done by laboratory staff in London and nurses in Stuttgart. The Pearson coefficient (R) and Wilcoxon test were used for statistical analysis. RESULTS: Some 234 patients (55 male, 179 female) with a median age of 58.5 (age full range 15-88) years underwent parathyroidectomy (195 minimally invasive, 38 bilateral neck exploration, 1 thoracoscopic; 12 conversions) for primary hyperparathyroidism between November 2021 and July 2022. Primary hyperparathyroidism was cured in 225 patients (96.2%). The sensitivity, specificity, and overall accuracy of the Analyzer assay in predicting biochemical cure were 83.9, 100, and 84.8% in phase 1; 91.2, 100, and 91.3% in phase 2; and 98.6, 100, and 98.6% in phase 3. There were no false-positive results (positive predictive value 100%). Correlations between Analyzer measurements and those obtained using the Roche device were very strong (R = 0.98, P < 0.001 in phase 1; R = 0.92, P < 0.001 in phase 2; R = 0.94, P < 0.001 in phase 3), and correlations for Analyzer readings versus those from the Abbott platform were strong (R = 0.82, P < 0.001; R = 0.89, P < 0.001; R = 0.91, P < 0.001). The Analyzer showed continued good mechanical performance, with stable and repeatable operations (calibrations, quality controls). Introducing a stricter sampling protocol and improvements in the clot-detecting system led to a decrease in the number of clotted samples and false-negative results. Outcomes were not affected by measurements performed either by nurses or laboratory staff. CONCLUSION: Intraoperative PTH monitoring during parathyroid surgery can be done accurately, simply, and quickly in whole blood using the Analyzer.

Life cycle assessment of animal-based foods and plant-based protein-rich alternatives: an environmental perspective.

BACKGROUND: In the European Union proteins for food are largely animal based, consisting of meat and dairy products. Almost all soy but also a larger part of pulses and cereals consumed in the European Union are used for animal nutrition. While livestock is an important source of proteins, it also creates substantial environmental impacts. The food and feed system is closely linked to the planetary and health boundaries and a transformation to healthy diets will require substantial dietary shifts towards healthy foods, such as nuts, fruits, vegetables and legumes. RESULTS: Extrudated vegetable meat alternatives consisting of protein combined with amaranth or buckwheat flour and a vegetable milk alternative made from lentil proteins were shown to have the potential to generate significantly less environmental impact than their animal-based counterparts in most of the environmental indicators examined, taking into account both functional units (mass and protein content). The underlying field-to-fork life cycle assessment models include several variants for both plant and animal foods. The optimized plant-based foods show a clear potential for improvement in the environmental footprints. CONCLUSIONS: Development of higher processed and therefore higher performing products is crucial for appealing to potential user groups beyond dedicated vegetarians and vegans and ultimately achieving market expansion. The Protein2Food project showed that prototypes made from European-grown legumes and pseudocereals are a valuable source for high-quality protein foods, and despite being substantially processed they could help reduce the environmental impact of food consumption. © 2021 Society of Chemical Industry.

How Long Does It Take to Regain Normocalcaemia in the Event of Postsurgical Hypoparathyroidism? A Detailed Time Course Analysis.

Background: Postsurgical hypoparathyroidism (PH) is the most common side effect of bilateral thyroid resections. Data regarding the time course of recovery from PH are currently unavailable. Therefore, a detailed analysis of the time course of PH recovery and conditions associated with rapid recovery was conducted. Methods: This is a retrospective analysis of prospectively documented data. Patients with biochemical signs of PH or need for calcium supplementation were followed-up for 12 months. Logistic regression analyses were used to identify covariates of early as opposed to late recovery from PH. Results: There were 1097 thyroid resections performed from 06/2015 to 07/2016 with n = 143 PH. Median recovery time was 8 weeks and six patients (1.1% of total thyroid resections) required calcium supplementation > 12 months. Recovery of PH within 4 and 12 weeks was characterized by high PTH levels on the first postoperative day (4 weeks: OR 1.13, 95% CI 1.06−1.20; 12 weeks: OR 1.08, 95%CI 1.01−1.16). Visualization of all PTGs emerged as an independent predictor of recovery within 12 months (OR 2.32, 95% CI 1.01−4.93) and 24 weeks (OR 2.69, 95% CI 1.08−6.69). Conclusion: In the setting of specialized high-volume endocrine surgery, permanent PH is rare. However, every second patient will require more than 2 months of continued medical surveillance. Early recovery was associated with only moderately decreased postsurgical PTH-levels. Successful late recovery appeared to be associated with the number of parathyroid glands visualized during surgery.

In-hospital delay increases the risk of perforation in adults with appendicitis.

BACKGROUND: The influence of in-hospital delay (time between admission and operation) on outcome after appendectomy is controversial. METHODS: A total of 1,827 adult patients underwent open or laparoscopic appendectomy for suspected appendicitis in eleven Swiss hospitals between 2003 and 2006. Of these, 1,675 patients with confirmed appendicitis were included in the study. Groups were defined according in-hospital delay (≤12 vs. >12 h). RESULTS: Delay>12 h was associated with a significantly higher frequency of perforated appendicitis (29.7 vs. 22.7%; P=0.010) whereas a delay of 6 or 9 h was not. Size of institution, time of admission, and surgical technique (laparoscopic vs. open) were independent factors influencing in-hospital delay. Admission during regular hours was associated with higher age, higher frequency of co-morbidity, and higher perforation rate compared to admission after hours. The logistic regression identified four independent factors associated with an increased perforation rate: age (≤65 years vs. >65 years, odds ratio (OR) 4.5, P<0.001); co-morbidity (Charlson index>0 vs. Charlson index=0, OR 2.3, P<0.001); time of admission (after hours vs. regular hours, OR 0.8, P=0.040), in-hospital delay (>12 vs. ≤12 h, OR 1.5, P=0.005). Perforation was associated with an increased reintervention rate (13.4 vs. 1.6%; P<0.001) and longer length of hospital stay (9.5 vs. 4.4 days; P<0.001). CONCLUSIONS: In-hospital delay negatively influences outcome after appendectomy. In-hospital delay of more than 12 h, age over 65 years, time of admission during regular hours, and the presence of co-morbidity are all independent risk factors for perforation. Perforation was associated with a higher reintervention rate and increased length of hospital stay.

[18F]fluoro-ethylcholine-PET Plus 4D-CT (FEC-PET-CT): A Break-Through Tool to Localize the "Negative" Parathyroid Adenoma. One Year Follow Up Results Involving 170 Patients.

BACKGROUND: The diagnostic performance of [18F]fluoro-ethylcholine-PET-CT&4D-CT (FEC-PET&4D-CT) to identify parathyroid adenomas (PA) was analyzed when ultrasound (US) or MIBI-Scan (MS) failed to localize. Postsurgical one year follow-up data are presented. METHODS: Patients in whom US and MS delivered either incongruent or entirely negative findings were subjected to FEC-PET&4D-CT and cases from July 2017 to June 2020 were analyzed, retrospectively. Cervical exploration with intraoperative PTH-monitoring (IO-PTH) was performed. Imaging results were correlated to intraoperative findings, and short term and one year postoperative follow-up data. RESULTS: From July 2017 to June 2020 in 171 FEC-PET&4D-CTs 159 (92.9%) PAs were suggested. 147 patients already had surgery, FEC-PET&4D-CT accurately localized in 141; false neg. 4, false pos. 2, global sensitivity 0.97; accuracy 0.96, PPV 0.99. All of the 117 patients that already have completed their 12-month postoperative follow up had normal biochemical parameter, i.e., no signs of persisting disease. However, two cases may have a potential for recurrent disease, for a cure rate of at least 98.3%. CONCLUSION: FEC-PET&4D-CT shows unprecedented results regarding the accuracy localizing PAs. The one-year-follow-up data demonstrate a high cure rate. We, therefore, suggest FEC-PET-CT as the relevant diagnostic tool for the localization of PAs when US fails to localize PA, especially after previous surgery to the neck.

Neuromonitoring of the Recurrent Laryngeal Nerve Reduces the Rate of Bilateral Vocal Cord Dysfunction in Planned Bilateral Thyroid Procedures.

PURPOSE: Bilateral vocal cord dysfunction (bVCD) is a rare but feared complication of thyroid surgery. This long term retrospective study determined the effect of intraoperative neuromonitoring (IONM) of the recurrent laryngeal nerve (RLN) during thyroid surgeries with regard to the rate of bVCD and evaluated the frequency as well as the outcome of staged operations. METHODS: Retrospective analysis of prospectively documented data (2000-2019) of a tertiary referral centers' database. IONM started in 2000 and, since 2010, discontinuation of surgery was encouraged in planned bilateral surgeries to prevent bVCD, if non-transient loss of signal (ntLOS) occurred on the first side. Datasets of the most recent 40-month-period were assessed in detail to determine the clinical outcome of unilateral ntLOS in planned bilateral thyroid procedures. RESULTS: Of 22,573 patients, 65 had bVCD (0.288%). The rate of bVCD decreased from 0.44 prior to 2010 to 0.09% after 2010 (p < 0.001, Chi2). Case reviews of the most recent 40 months period identified ntLOS in 113/3115 patients (3.6%, 2.2% NAR), of which 40 ntLOS were recorded during a planned bilateral procedure (n = 952, 2.1% NAR). Of 21 ntLOS occurring on the first side of the bilateral procedure, 15 procedures were stopped, subtotal contralateral resections were performed, and thyroidectomy was continued in 3 patients respectively, with the use of continuous vagal IONM. Eighteen cases of VCD were documented postop, and all but one patient had a full recovery. Seven patients had staged resections after 1 to 18 months (median 4) after the first procedure. CONCLUSION: IONM facilitates reduced postoperative bVCD rates. IONM is, therefore, recommendable in planned bilateral procedures. The rate of non-complete bilateral surgery after intraoperative non-transient LOS was 2%.

Comparison of Faba Bean Protein Ingredients Produced Using Dry Fractionation and Isoelectric Precipitation: Techno-Functional, Nutritional and Environmental Performance.

Dry fractionated faba bean protein-rich flour (FPR) produced by milling/air classification, and faba bean protein isolate (FPI) produced by acid extraction/isoelectric precipitation were compared in terms of composition, techno-functional properties, nutritional properties and environmental impacts. FPR had a lower protein content (64.1%, dry matter (DM)) compared to FPI (90.1%, DM), due to the inherent limitations of air classification. Of the two ingredients, FPR demonstrated superior functionality, including higher protein solubility (85%), compared to FPI (32%) at pH 7. Foaming capacity was higher for FPR, although foam stability was similar for both ingredients. FPR had greater gelling ability compared to FPI. The higher carbohydrate content of FPR may have contributed to this difference. An amino acid (AA) analysis revealed that both ingredients were low in sulfur-containing AAs, with FPR having a slightly higher level than FPI. The potential nutritional benefits of the aqueous process compared to the dry process used in this study were apparent in the higher in vitro protein digestibility (IVPD) and lower trypsin inhibitor activity (TIA) in FPI compared to FPR. Additionally, vicine/convicine were detected in FPR, but not in FPI. Furthermore, much lower levels of fermentable oligo-, di- and monosaccharides, and polyols (FODMAPs) were found in FPI compared to FPR. The life cycle assessment (LCA) revealed a lower environmental impact for FPR, partly due to the extra water and energy required for aqueous processing. However, in a comparison with cow's milk protein, both FPR and FPI were shown to have considerably lower environmental impacts.

Techno-Functional, Nutritional and Environmental Performance of Protein Isolates from Blue Lupin and White Lupin.

Similarly prepared protein isolates from blue lupin (Lupinus angustifolius) and white lupin (L. albus) were assessed in relation to their composition, functional properties, nutritional attributes and environmental impacts. Blue lupin protein isolate (BLPI) and white lupin protein isolate (WLPI) were found to be quite similar in composition, although differences in the electrophoretic protein profiles were apparent. Both lupin protein isolates (LPIs) had good protein solubility (76.9% for BLPI and 69.8% for WLPI at pH 7) and foaming properties. However, a remarkable difference in heat gelation performance was observed between BLPI and WLPI. WLPI had a minimum gelling concentration of 7% protein, whereas BLPI required 23% protein in order to form a gel. WLPI also resulted in stronger gels over a range of concentrations compared to BLPI. Nutritional properties of both LPIs were similar, with no significant differences in in vitro protein digestibility (IVPD), and both had very low trypsin inhibitor activity (TIA) and fermentable oligo-, di- and monosaccharides, and polyols (FODMAP) content. The amino acid profiles of both LPIs were also similar, with sulfur-containing amino acids (SAAs) being the limiting amino acid in each case. Environmental impacts revealed by the life cycle assessment (LCA) were almost identical for BLPI and WLPI, and in most categories the LPIs demonstrated considerably better performance per kg protein when compared to cow's whole milk powder.

Impact of preoperative Vitamin D3 administration on postoperative hypocalcaemia in patients undergoing total thyroidectomy (HypoCalViD): study protocol for a randomized controlled trial.

BACKGROUND: Total thyroidectomy is increasingly used as a surgical approach for many thyroid conditions. Subsequently, postoperative hypocalcaemia is observed with increasing frequency, often resulting in prolonged hospital stay, increased use of resources, reduced quality of life and delayed return to work. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia; calcitriol is most commonly used. What has not been examined so far is whether and how routine preoperative vitamin D prophylaxis using calcitriol can help to prevent postoperative hypocalcaemia. This study evaluates routine preoperative calcitriol prophylaxis for all patients who are to undergo a total thyroidectomy, compared with the current standard of post-treatment, i.e., selective vitamin D treatment for patients with postoperative hypocalcaemia. METHODS/DESIGN: This clinical observational (minimal interventional clinical trial) trial is a multicentre, prospective, randomized superiority trial with an adaptive design. Datasets will be pseudonymized for analysis. Patients will be randomly allocated (1:1) to the intervention and the control groups. The only intervention is 0.5 µg calcitriol orally twice a day for 3 days prior to surgery. For the primary endpoint measure (number of patients with hypocalcaemia), hypocalcaemia is defined as serum calcium of less than 2.1 mmol/l on any day during the postoperative course; this measure will be analyzed using a Chi-square test comparing the two groups. Secondary endpoint measures, such as number of days to discharge, quality of life, and economic parameters will also be analyzed. DISCUSSION: By virtue of the direct comparison of clinically and economically relevant endpoints, the efficacy as well as efficiency of preoperative calcitriol prophylaxis of hypocalcaemia will be clarified. These results should be available 24 months after the first patient has been enrolled. The results will be used to inform a revised practice parameter guideline of whether or not to recommend preoperative calcitriol for all patients in whom total thyroidectomy is planned. TRIAL REGISTRATION: Deutsches Register Klinischer Studien, DRKS00005615 (Feb.12.2016).

The relevance of work-related learning for vulnerable groups. Dutch case study of a Health Impact Assessment with equity focus.

INTRODUCTION: Learning is essential for sustainable employability. However, various factors make work-related learning more difficult for certain groups of workers, who are consequently at a disadvantage in the labour market. In the long term, that in turn can have adverse health implications and can make those groups vulnerable. With a view to encouraging workers to continue learning, the Netherlands has a policy on work-related learning, which forms part of the 'Vitality Package'. AIM: A Health Impact Assessment with equity focus (HIAef) was undertaken to determine whether the policy on work-related learning affected certain groups of workers and their health in different ways, and whether the differences were avoidable. METHODS: The HIAef method involved the standard phases: screening, scoping, appraisal and recommendations. Equity was the core principle in this method. Data were collected by means of both literature searches (e.g., Scopus, Medline) and interviews with experts and stakeholders (e.g., expertise regarding work, training and/or health). RESULTS: The HIAef identified the following groups as potentially vulnerable in the field of work-related learning: the chronically sick, older people, less educated people, flexi-workers/the self-employed and lay carers (e.g., thresholds to learning). Published literature indicates that work-related learning may have a positive influence on health through (work-related) factors such as pay, employability, longer employment rate and training-participation. According to experts and stakeholders, work-related learning policy could be adapted to take more account of vulnerable groups through alignment with their particular needs, such as early support, informal learning and e-learning. CONCLUSION: With a view to reducing avoidable inequalities in work-related learning, it is recommended that early, low-threshold, accessible opportunities are made available to identified vulnerable groups. Making such opportunities available may have a positive effect on (continued) participation in the labour market and thus on the health of the relevant groups.