Patients' contribution to drug safety in Catalonia: the interest of personal feelings on adverse drug reactions.

PURPOSE: There are few studies on the personal view retrieved by patients in the spontaneous reports' free-text section of suspected adverse drug reactions. METHODS: We analysed the suspected adverse drug reactions (ADRs) spontaneous reports sent to the Catalan Centre of Pharmacovigilance between 2013 and 2017. The information provided in the free-text section was classified as (1) temporal sequence, (2) description of symptoms, (3) description of psychological impact, (4) withdrawal effects, (5) alternative causes, and (6) rechallenge. The concordance level between the perceived severity by the reporter and the pharmacovigilance team was assessed by the Kappa index (ƙ). Usual descriptive statistics were used to describe variables. RESULTS: Nationally, 190 spontaneous reports described 383 ADRs, which 28.6% were unknown or poorly known in the literature, and 52.1% were serious. The most frequent ADRs were gastrointestinal (19.3%) and neurological (19.1%), and among the most common 213 suspected medicines, there were those used for nervous system conditions (18.8%). The agreement on the perception of ADRs' severity between citizens and centre's technicians was 'good' (K = 0.62 (0.51-0.72)). An analysis of the free-text section of reports showed that one-quarter of the reports provided useful additional data, like the psychobiosocial impact, which could explain the discrepancy between patients and health professionals in the classification of the severity of some ADRs. CONCLUSIONS: Patients' report free-text section provides relevant information, mainly about symptoms description, psychobiosocial impact and feelings. Therefore, it is a section to be enhanced and analysed. These findings should encourage the strengthening of citizens reporting.

National critical incident reporting systems relevant to anaesthesia: a European survey.

BACKGROUND: Critical incident reporting is a key tool in the promotion of patient safety in anaesthesia. METHODS: We surveyed representatives of national incident reporting systems in six European countries, inviting information on scope and organization, and intelligence on factors determining success and failure. RESULTS: Some systems are government-run and nationally conceived; others started out as small, specialty-focused initiatives, which have since acquired a national reach. However, both national co-ordination and specialty enthusiasts seem to be necessary for an optimally functioning system. The role of reporting culture, definitional issues, and dissemination is discussed. CONCLUSIONS: We make recommendations for others intending to start new systems and speculate on the prospects for sharing patient safety lessons relevant to anaesthesia at European level.

The Next Food Revolution Is Here: Recombinant Microbial Production of Milk and Egg Proteins by Precision Fermentation.

Animal-based agriculture and the production of protein-rich foods from animals, particularly from ruminants, are not sustainable and have serious climate effects. A new type of alternative proteins is now on the menu, namely animal proteins produced recombinantly by microbial fermentation. This new technology, precision fermentation, is projected to completely disrupt traditional animal-based agriculture. Certain milk and egg proteins along with specific meat substitute analog components produced by precision fermentation are already entering the market. This first wave of precision fermentation products targets the use of these proteins as protein additives, and several commercial players are already active in the field. The cost-efficiency requirements involve production titers above 50 g/L which are several orders of magnitude higher than those for pharmaceutical protein manufacture, making strain engineering, process optimization, and scale-up critical success factors. This new development within alternative proteins defines a new research direction integrating biotechnology, process engineering, and sustainable food protein production.

Modelling of salt uptake for salt content standardization in dry-cured ham.

Salt content standardization in dry-cured ham production is complex as there are many factors that influence salt uptake. The aim of this work was to study and model salt uptake as a function of salting time and the characteristics of green ham in two different ham types using a large amount of data obtained from an inline non-invasive characterization technology. The usefulness of these models to standardize the salt content of the industrial production was also evaluated. Magnetic induction technology was used to characterize lean and fatty hams in order to further model the salt uptake using different statistical methods. Salt content increased with the salting time showing an asymptotic behaviour which was lower in fatty hams. The best models were those that considered the salting time, weight, and fat content of hams as model independent variables. These models are helpful for salt content standardization within the industry and can be used to simulate process modifications and avoid the time-consuming and costly trial and error tests.

Processing parameters involved in the development of texture and tyrosine precipitates in dry-cured ham: Modelisation of texture development.

The aim of this study was to quantify the effects of different processing parameters on texture development and the incidence of white film and tyrosine crystals in dry-cured ham. Hams were dry-salted for 0.65, 0.8 or 1.0 days/kg. After drying for 45 days at 5 °C, they were dried at 10, 15 or 20 °C until reaching 33% weight loss and, thereafter, dried at 25 °C until reaching 36 or 40% weight loss. The salting time, drying temperature and target weight loss significantly affected the texture and incidence of white film and tyrosine crystals. A beneficial effect of drying at 20 °C on texture was found, which was especially important for low target weight loss (33%). Besides, hams dried at 20 °C and those with 40% weight loss showed higher incidence of tyrosine crystals. Contour plots and predictive models for texture can be used to define optimal processing parameters.

Instrumental texture analysis on the surface of dry-cured ham to define the end of the process.

The end of the elaboration process of dry-cured ham is currently decided by product weight loss and/or by an expert who carries out an evaluation of the tactile texture on the surface. The objective of this study was to define the optimal measurement conditions of an instrumental texture analysis on the surface of the dry-cured ham (ITAS), to define the end of process. 120 dry-cured hams were classified by experts into Hard (appropriate) or Soft (non-appropriate) texture groups and used to perform compression tests using different probes on three anatomical positions. Results showed that the small probe in position 2 gave the most discriminant conditions, providing representative information of the internal texture. Although classification using only weight loss was possible with an accuracy rate of 80.4% or 66.7% depending on the weight loss, the maximum classification accuracy was obtained when using ITAS in combination with weight loss. Further studies at industrial level are needed.

Association between nitrous oxide and the incidence of postoperative nausea and vomiting in adults: a systematic review and meta-analysis.

Some, but not all studies have suggested intra-operative use of nitrous oxide is correlated with postoperative nausea and vomiting. We performed a meta-analysis of randomised controlled trials to compare the incidence of nausea and vomiting in adults following general anaesthesia with or without nitrous oxide. We retrieved 30 studies (incorporating 33 separate trials) that investigated a 'nitrous oxide group' (total 2297 patients) vs a 'no-nitrous oxide group' (2301 patients). Omitting nitrous oxide significantly reduced postoperative nausea and vomiting (pooled relative risk 0.80, 95% CI 0.71-0.90, p = 0.0003). However, the absolute incidence of nausea and vomiting was high in both the nitrous oxide and no-nitrous oxide groups (33% vs 27%, respectively). In subgroup analysis, the maximal risk reduction was obtained in female patients (pooled relative risk 0.76, 95% CI 0.60-0.96). When nitrous oxide was used in combination with propofol, the antiemetic effect of the latter appeared to compensate the emetogenic effect of nitrous oxide (pooled relative risk 0.94, 95% CI 0.77-1.15). We conclude that avoiding nitrous oxide does reduce the risk of postoperative nausea and vomiting, especially in women, but the overall impact is modest.

[Postoperative nausea and vomiting and opioid-induced nausea and vomiting: guidelines for prevention and treatment]. / Recomendaciones de prevención y tratamiento de las náuseas y vómitos postoperatorios y/o asociados a las infusiones de opioides.

Postoperative nausea and vomiting (PONV) causes patient discomfort, lowers patient satisfaction, and increases care requirements. Opioid-induced nausea and vomiting (OINV) may also occur if opioids are used to treat postoperative pain. These guidelines aim to provide recommendations for the prevention and treatment of both problems. A working group was established in accordance with the charter of the Sociedad Española de Anestesiología y Reanimación. The group undertook the critical appraisal of articles relevant to the management of PONV and OINV in adults and children early and late in the perioperative period. Discussions led to recommendations, summarized as follows: 1) Risk for PONV should be assessed in all patients undergoing surgery; 2 easy-to-use scales are useful for risk assessment: the Apfel scale for adults and the Eberhart scale for children. 2) Measures to reduce baseline risk should be used for adults at moderate or high risk and all children. 3) Pharmacologic prophylaxis with 1 drug is useful for patients at low risk (Apfel or Eberhart 1) who are to receive general anesthesia; patients with higher levels of risk should receive prophylaxis with 2 or more drugs and baseline risk should be reduced (multimodal approach). 4) Dexamethasone, droperidol, and ondansetron (or other setrons) have similar levels of efficacy; drug choice should be made based on individual patient factors. 5) The drug prescribed for treating PONV should preferably be different from the one used for prophylaxis; ondansetron is the most effective drug for treating PONV. 6) Risk for PONV should be assessed before discharge after outpatient surgery or on the ward for hospitalized patients; there is no evidence that late preventive strategies are effective. 7) The drug of choice for preventing OINV is droperidol.

Causes for cancellation of elective surgical procedures in a Spanish general hospital.

Cancellation of scheduled surgery is undesirable for patients and an inefficient use of resources. We prospectively collected data for 52 consecutive months in a public general hospital to estimate the prevalence and causes. The overall cancellation rate was 6.5% (2559 of 39 115 scheduled operations). Cancellation by broad category was for 'medical reasons' in 50%, 'patient-related factors' in 23%, and due to 'administrative/logistic problems' in 25%. The commonest specific causes within these categories were respectively: infections/fever (18%), patient did not attend (20%) and lack of theatre time (23%). This data will help direct resources to target prevention of cancellations as a result of these main problems.

Desorption isotherms of salted minced pork using K-lactate as a substitute for NaCl.

The aim of this study was to obtain and compare water desorption isotherms of ground meat containing NaCl (0.107kg NaCl/kg raw-meat dry matter) and/or K-lactate as NaCl substitute at two different levels of molar substitution (30% and 100%). A thin layer of salted ground meat was dried and sampled at pre-determined times. The moisture content of the samples and their water activities (a(w)) were measured at 5°C and 25°C. Results showed that ground meat with NaCl and/or different K-lactate contents had a similar water desorption isotherm for a(w) ranging from 0.7 to 1.0. Below 0.7, the water equilibrium content fell with small decreases in a(w) faster for meat with NaCl than for meat with K-lactate. K-lactate could reduce the excessive hardening at the surface of salted meat products. Experimental desorption isotherms were compared to those estimated using two approaches of the Ross equation. Models provided a good fit for the experimental data.

Reduction of NaCl content in restructured dry-cured hams: Post-resting temperature and drying level effects on physicochemical and sensory parameters.

The effects of post-resting temperature (5°C, 15°C and 25°C) and drying level (low and high, corresponding to final water contents (w/w) of 57% and 50%, respectively) were evaluated in restructured dry-cured hams. The reduction of NaCl content, with and without the addition of K-lactate as NaCl substitute was also evaluated. Physicochemical and instrumental colour and texture (Stress Relaxation test) parameters and sensory attributes were measured. The main effects of reducing the NaCl addition from 30g/kg to 15g/kg in restructured dry-cured hams were the reduction of saltiness and the increase of a(w), proteolysis and softness. The addition of K-lactate (19.7g/kg) contributed to reduce these effects. Hams from high drying level had a longer processing time and a higher proteolysis index, but lower water content and harder texture. The increase of post-resting temperature to above 5°C reduced the processing time and the metallic flavour, but at 25°C restructured hams were spoiled. Therefore, the problems due to the reduction of NaCl to 15g/kg in restructured dry-cured hams can be reduced by adding K-lactate and drying at 15°C (after 3.5months of resting at 5°C) until a final weight loss of around 45% is reached.

Effects of potassium lactate and high pressure on transglutaminase restructured dry-cured hams with reduced salt content.

Ten raw hams (from 5 carcasses) were boned and salted either with salt reduction (15g/kg NaCl) or salt reduction with addition of potassium lactate (15g/kg NaCl and 39.74g/kg of a 60% K-lactate solution). Subsequently, the ham pieces were assembled together with transglutaminase, vacuum packed into water-permeable plastic bags and kept at 3°C and 85% RH until reaching above 30% weight losses. The effects of K-lactate addition and the high-pressure (HP) treatment at 600MPa on the physicochemical, instrumental colour and texture (Tensile test) and sensory characteristics of the biceps femoris (BF) muscle were evaluated. The addition of K-lactate did not have a negative effect on colour, flavour or texture of restructured dry-cured hams. The HP treatment increased significantly the pH, L(∗), a(∗) and b(∗) values and the breaking stress, and decreased the water-holding capacity and elasticity (apparent Young's modulus) of BF muscle. The HP treatment also affected significantly the flavour (increasing saltiness, umami and sweetness) and the sensory texture attributes (increasing muscle binding, hardness, gumminess and fibrousness and decreasing adhesiveness and pastiness), as well as slice appearance (increasing brightness and iridescence and decreasing colour homogeneity).

Effect of high pressure processing temperature on dry-cured hams with different textural characteristics.

High pressure processing is mainly used to eliminate pathogenic microorganisms and extend the shelf-life of dry-cured hams, but it also modifies its texture. These changes might be different depending on the initial textural characteristics. In this study, texture, colour and colour stability were evaluated after pressurization at 600 MPa during 6 min at 7 °C, 20 °C and 35 °C in samples with different textural characteristics (no pastiness, medium and high pastiness groups). HP treatments produced an increase of hardness (F0) and lightness (L*) values and a decrease of softness/pastiness (Y2 and Y90) and redness (a*) values at any processing temperatures. However, the increase of F0 and L* values was more pronounced in non-pasty samples. In samples with high pastiness and softness, HP processing at high temperature (35 °C) reduced the intensity of pastiness. However, texture of hams with non-pasty texture might be negatively affected. Therefore, the optimal temperature of HP processing depends on the textural characteristics of dry-cured hams.

Predictive value of six risk scores for outcome after surgical repair of hip fracture in elderly patients.

BACKGROUND: Hip fracture surgery is associated with high post-operative mortality and poor functional results: the excess mortality is 20% in the first year; of those patients who survive, only 50% recover their previous ability to walk. The purpose of this study was to assess the predictive value of six functional status and/or surgical risk scoring systems with regard to serious complications after hip fracture surgery in the elderly. METHODS: We performed a prospective study of a consecutive series of 232 patients (aged 65 years or older) undergoing hip fracture surgery. We pre-operatively applied: The American Society of Anesthesiologists classification, the Barthel index, the Goldman index, the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) scoring system, the Charlson index and the Visual Analogue Scale for Risk (RISK-VAS) scale. These scales were evaluated with respect to three variables: incidence of serious complications, the ability to walk after a 3-month period and 90-day survival. The predictive value of the different scales was assessed by the calculated area under a receiver operating characteristic curve. RESULTS: The RISK-VAS scale, the POSSUM scoring system and the Charlson index reached a sufficient predictive value with regard to serious post-operative complications. The Barthel index and the RISK-VAS scale were those most useful for predicting ambulation at 3 months. None of the scales proved to be capable of predicting 90-day mortality. CONCLUSIONS: A simple index such as the RISK-VAS scale was the best predictor of serious post-operative complications. The functional level before the fracture, measured with the Barthel index, had a major influence on the ambulation recovery.

Effect of the inoculation of a starter culture and vacuum packaging (during resting stage) on the appearance and some microbiological and physicochemical parameters of dry-cured ham.

The effect of the inoculation of a starter culture and vacuum packaging (during the resting stage) on dry-cured ham appearance, microbiological and physicochemical parameters was studied. Half of the 36 processed hams were inoculated, after salting, with a commercial starter culture containing lactic-acid bacteria, Gram-positive catalase-positive cocci and yeasts. 18 hams per group (inoculated and non-inoculated) remained vacuum packaged during resting. Microbiological analyses were carried out on the lean surface during processing, on subcutaneous fat tissue at the drying stage and on lean tissue in the finished product. Appearance was evaluated during processing. Physicochemical analyses (NaCl, H(2)O, proteolysis index, a(w)) were done on Semimembranosus and Biceps femoris in the final product. Inoculation caused a reduction of mould growth and oil drip. Vacuum packaging induced increased proteolysis and increases in all microbial counts and a reduction of oil drip, mould growth and weight loss during processing.

Effect of the inoculation of a starter culture and vacuum packaging during the resting stage on sensory traits of dry-cured ham.

The effects of the inoculation of a mixed starter culture and vacuum packaging (during resting stage) on odour, appearance, texture and flavour of dry-cured ham were studied. After salting, half of the 36 processed hams were inoculated with a commercial starter culture containing lactic-acid bacteria, Gram-positive catalase-positive cocci and yeasts. Nine hams per group (inoculated and non-inoculated) remained vacuum-packaged during resting. External odour during the process, as well as appearance of the cut surface, texture and flavour on semimembranosus and biceps femoris of the final product were assessed. Vacuum packaging during resting caused an increase in white film and feedstuff flavour, as well as a decrease in aged flavour, hardness, fibrousness and overall liking. The use of the starter culture brought about an increase in feedstuff flavour, a decrease in sweetness, aged flavour, nutty flavour and overall liking and, only in vacuum-packaged hams, the development of a floral flavour, but had no significant effect on texture descriptors. The starter culture studied is considered inappropriate for the production of traditional Spanish dry-cured ham regardless of the type of resting used.

Texture changes in dry-cured ham pieces by mild thermal treatments at the end of the drying process.

The present study evaluated the effects of mild thermal treatments at the end of the drying process on physicochemical characteristics and instrumental and sensory texture in dry-cured ham. Experiment 1: effect of thermal treatments (4-46°C) for 4h and 24h. Experiment 2: time effect (4-168h) of thermal treatments at 30°C and 36°C. Both experiments were done on small dry-cured ham dices. Experiment 3: time effect (4-168h) of thermal treatment at 30°C on both instrumental and sensory texture of 4-cm-thick sections of dry-cured ham. The thermal treatment at 30°C for 168h on both dry-cured ham muscle dices (20mm×20mm×15mm) and dry-cured ham sections (4cmthick) decreased softness, adhesiveness and pastiness in BF muscle, without increasing hardness in SM muscle or affecting moisture, a(w) and proteolysis index.

Sensory characterisation and consumer acceptability of small calibre fermented sausages with 50% substitution of NaCl by mixtures of KCl and potassium lactate.

The effect of six mixtures with 50% molar substitution of KCl (0-50%) and potassium lactate (0-50%) as NaCl substitutes in small calibre fermented sausages on some sensory parameters and on the acceptability was studied. Also, the relationship between sensory profile and consumer acceptability using external preference mapping was investigated. The results showed that as the K-lactate substitution increased, pH, sweetness, crumbliness and pastiness also increased, and piquantness, hardness, cohesiveness, ripened flavour, acid taste and saltiness decreased. However, the treatments prepared with a high level of salt substitution by KCl showed scores of sensory attributes similar to those of the control. Consumer segmentation showed differences in acceptability between genders, place of residence, educational level and age group. Consumers rejected fermented sausages with high K-lactate substitution but not those with a high KCl substitution. External preference mapping split consumers up into four clusters with different preference patterns. According to these results and from a sensory point of view, it is possible to achieve a reduction of 50% of NaCl in small calibre fermented sausages and to obtain a product acceptable to most consumers.

Effect of a 10-day ageing at 30°C on the texture of dry-cured hams processed at temperatures up to 18°C in relation to raw meat pH and salting time.

The aim of this study was to investigate the effect of a 10-day ageing at 30±2°C on the texture of dry-cured hams processed at temperatures up to 18±2°C for 12 months in relation with raw ham pH and salting time. Three pH groups (semimembranosus muscle at 24h post-mortem: Low pH<5.7, Medium pH=5.7⩽pH⩽5.9, and High pH>5.9), three salting times (6d, 10d and 14d) and two ageing temperatures (18°C and 30°C) were investigated. Physicochemical characteristics, instrumental and sensory texture and product sliceability were evaluated on biceps femoris and semimembranosus muscles. Hams with pH(SM24)<5.7 should be avoided in order to reduce the incidence of texture problems in dry-cured ham elaboration. Texture problems are especially important in hams with a reduced salt content that are mechanically sliced (not frozen). A 10-day ageing at 30°C could be useful for reducing the soft texture problems in dry-cured hams processed at temperatures up to 18°C for 12 months without affecting the product flavour.

Sorption isotherms of salted minced pork and of lean surface of dry-cured hams at the end of the resting period using KCl as substitute for NaCl.

The effect of KCl on sorption isotherms was determined on salted minced meat (with 0%, 30% and 100% molar substitution of NaCl by KCl) at 5°C and 25°C and meat from a 3mm thick slice from the surface of dry-cured hams (with 0% and 35% molar substitution of NaCl by KCl) held at 70-75%, 75-80% and 80-85% air relative humidity during the resting period. The sorption isotherms were determined gravimetrically by exposing the meat samples to several atmospheres of known relative humidity controlled by different saturated salts according to the COST90 method. The sorption equipment consisted of a chamber containing 11 containers, covering the water activity (a(w)) range from 0.112 to 0.946 at 25°C. The hermetically closed sorption containers filled with KCl and minced meat samples were irradiated at 3kGrey (gamma irradiation (60)Co). The water content at equilibrium was higher in minced meat with NaCl than in minced meat with KCl (100% molar substitution of NaCl by KCl) at 5°C within the range of 0.4313 and 0.7565 a(w). However, when substitution was 30% in minced meat and 35% in hams the isotherms were similar to isotherm without substitution.