Low incidence of toxoplasma infection during pregnancy and in newborns in Sweden

To estimate the burden of disease due to congenital toxoplasmosis in Sweden the incidence of primary infections during pregnancy and birth prevalence of congenital toxoplasmosis in 40978 children born in two regions in Sweden was determined. Women possibly infected during pregnancy were identified based on: 1, detection of specific IgG based on neonatal screening of the phenylketonuria (PKU) card blood spot followed by retrospective testing of stored prenatal samples to detect women who acquired infection during pregnancy and follow up of their children to 12 months; 2, detection of specific IgM on the PKU blood spot. The birth prevalence of congenital toxoplasmosis was 0·73/10000 (95% CI 0·15–2·14) (3/40978). The incidence of primary infection during pregnancy was 5·1/10000 (95% CI 2·6–8·9) susceptible pregnant women. The seroprevalence in the southern part was 25·7% and in the Stockholm area 14·0%. The incidence of infection during pregnancy was low, as the birth prevalence of congenital toxoplasmosis. Neonatal screening warrants consideration in view of the low cost and feasibility

Glycolytic potential and ultimate muscle pH values in red deer (Cervus elaphus) and fallow deer (Dama dama)

The ultimate pH value of meat (measured at approx. 24 hours post slaughter) gives information about the technological quality, i.e. shelf life, colour, water-holding properties and tenderness and is a direct consequence of muscle glycogen (energy) levels at slaughter. It may therefore also indicate whether or not the animal has been exposed to stressful energy depleting events prior to slaughter. In the present study, 141 animals (130 red deer (Cervus elaphus) and 11 fallow deer (Dama dama) were included to investigate the relationship between ultimate pH and residual glycogen concentration in red deer and fallow deer M. longissimus. In addition, the muscle glycogen content and ultimate pH values in three red deer muscles (Mm. triceps brachii, longissimus and biceps femoris) were studied. M. triceps brachii had higher ultimate pH and lower glycogen content compared with the other two studied muscles. The frequency of intermediate DFD (5.8≤ pH<6.2) was 5.4% in red deer M. longissimus, compared with 9.1% in fallow deer, while the frequency of DFD (pH≥ 6.2) was much lower in red deer (3.8%) than in fallow deer (54.5%). A curvilinear relationship between ultimate pH and total glucose concentration (glycogen and glucose) 30 min post slaughter in red deer and fallow deer M. longissimus was found. The relationship between muscle pH and lactic acid concentration however, was indicated to be linear. A significant variation in total glucose concentration at ultimate pH below 5.80 was observed, including values in the range from 18 to 123 mmol/kg wet tissue. It was concluded that further studies are needed to further explore the relationship between muscle glycogen content and technological and sensory quality attributes of meat from different deer species.Abstract in Swedish / Sammanfattning:Köttets pH-värde (mätt ca 24 timmar efter slakt) har stor betydelse för den teknologiska kvaliteten som t. ex. hållbarhet, färg, vattenhållande förmåga och mörhet. Glykogenförrådet (energinivån) i djurens muskulatur vid slakt är helt avgörande för köttets slutliga pH-värde. Därför kan pH-värdet också indikera om hanteringen av slaktdjur varit skonsam eller om stora mängder muskelenergi har förbrukats vid stress. I vår undersökning ingick 141 hjortar (130 kronhjortar (Cervus elaphus) och 11 dovhjortar (Dama dama) för att studera sambandet mellan köttets pH-värde och glykogeninnehållet i M. longissimus. Glykogeninnehåll och pH-värden i 3 muskler från kronhjort (Mm. triceps brachii, longissimus och biceps femoris) undersöktes också. M. triceps brachii hade högre pH-värde och lägre glykogeninnehåll jämfört med de två andra musklerna. Det var inte så stor skillnad i frekvensen av intermediär DFD (pH-värden mellan 5,8 og 6,2) mellan de två hjortarterna (5,4% för kronhjort och 9,1% för dovhjort), däremot var frekvensen av DFD (pH-värden över 6,2) mycket låg hos kronhjort (3,8%) jämfört med dovhjort (54,5%). Det fanns ett kurvlinjärt samband mellan slutligt pH-värde i köttet och total glukoskoncentration (glykogen + glukos) mätt i M. longissimus 30 min efter slakt för både kron- och dovhjort. Ett linjärt samband mellan pH-värde och koncentration av mjölksyra i M. longissimus kunde också visas. Vi fann en mycket stor varitation i glukoskoncentration (18−123 mmol/kg våtvikt) när köttets pH-värdet var 5,8 eller lägre. Det behövs fler undersökningar för att vidare klargöra sambanden mellan glykogeninnehåll i muskulaturen och teknologisk och sensorisk kvalitet i olika typer av hjortkött

Colour stability and water-holding capacity of M. longissimus and carcass characteristics in fallow deer (Dama dama) grazed on natural pasture or fed barley

The effects of feeding regimen on carcass characteristics, meat colour and water-holding capacity of M. longissimus were studied in 24 female fallow deer (Dama dama). All animals were farm raised; twelve were grazed on pasture and twelve were fed barley and a small amount of hay prior to slaughter. The animals were slaughtered at two occasions (during the Southern Hemisphere spring); after 19 weeks of feeding (n=12; 6 grazing and 6 barley fed animals; group 1) and after 24 weeks of feeding (n=12; 6 grazing and 6 barley fed animals; group 2). The barley/hay-fed deer had significantly higher body condition scores and carcass weights than the pasture raised group. No difference in meat ultimate pH values between the treatment groups was recorded. The meat from the pasture raised deer had significantly longer colour display life after 2 and 3 weeks of refrigerated storage (+ 2.0 ºC) in vacuum bags. There was no difference in drip loss between the two treatment groups. However, significantly lower drip losses were found in meat from the animals in group 2 compared with the ones in group 1 (P ≤ 0.001). It was concluded that the feeding regimen of the animals is an important factor that contributes to the variation in quality of fresh chilled deer meat (venison), mainly the colour stability and display life of vacuum packaged meat.Abstract in Swedish / Sammanfattning: I denna undersökning ingick 24 dovhjortshindar (Dama dama) för att studera effekterna av olika typer av foder (bete och korn) på slaktkroppskvalitet samt färg och vattenhållande förmåga i köttet (M. longissimus). Alla djur var uppfödda på en hjortfarm, 12 betade gräs och 12 utfodrades med korn och en liten mängd hö före slakt. Djuren slaktades vid två olika tillfällen (under våren på det södra halvklotet); efter 19 veckors utfodring (n=12; 6 betesdjur och 6 kornfodrade djur; grupp 1) och efter 24 veckors utfodring (n=12; 6 betesdjur och 6 kornfodrade djur; grupp 2). De dovhjortar som utfodrats med korn och hö var i bättre kondition och hade högre slaktvikter jämfört med de djur som betat gräs. Ingen skillnad i köttets pH-värde mellan de två utfodringsgrupperna kunde dock påvisas. Köttet från de betande dovhjortarna hade bättre färgstabilitet efter lagring i 2 och 3 veckor (+ 2.0 ºC) i vakuumförpackning. Det fanns ingen skillnad mellan kött från betande och korn/hö-utfodrade djur i vattenhållande förmåga. Däremot hade kött från djur i grupp 2 (slaktade efter 24 veckors utfodring) bättre vattenhållande förmåga jämfört med grupp 1 (P ≤ 0.001). Vi kunde konstatera att de olika fodertyperna påverkade kvaliteten hos färskt kyllagrat kött, framförallt färgstabiliteten hos vakuumförpackat kött

Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program.

BackgroundPatient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process.MethodsConcept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items.ResultsDuring concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders.ConclusionDevelopment of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program

Assessment of the Food-Swallowing Process Using Bolus Visualisation and Manometry Simultaneously in a Device that Models Human Swallowing

The characteristics of the flows of boluses with different consistencies, i.e. different rheological properties, through the pharynx have not been fully elucidated. The results obtained using a novel in vitro device, the Gothenburg Throat, which allows simultaneous bolus flow visualisation and manometry assessments in the pharynx geometry, are presented, to explain the dependence of bolus flow on bolus consistency. Four different bolus consistencies of a commercial food thickener, 0.5, 1, 1.5 and 2\ua0Pa\ua0s (at a shear rate of 50\ua0s −1 )—corresponding to a range from low honey-thick to pudding-thick consistencies on the National Dysphagia Diet (NDD) scale—were examined in the in vitro pharynx. The bolus velocities recorded in the simulator pharynx were in the range of 0.046–0.48\ua0m/s, which is within the range reported in clinical studies. The corresponding wall shear rates associated with these velocities ranged from 13\ua0s −1 (pudding consistency) to 209\ua0s −1 (honey-thick consistency). The results of the in vitro manometry tests using different consistencies and bolus volumes were rather similar to those obtained in clinical studies. The in vitro device used in this study appears to be a valuable tool for pre-clinical analyses of thickened fluids. Furthermore, the results show that it is desirable to consider a broad range of shear rates when assessing the suitability of a certain consistency for swallowing

An instrument for measuring health-related quality of life in patients with Deep Venous Thrombosis (DVT): development and validation of Deep Venous Thrombosis Quality of Life (DVTQOL) questionnaire

BACKGROUND: Few studies have evaluated patient-reported outcomes in connection with a primary event of deep venous thrombosis, partly due to a lack of disease-specific measures. The aim here was to develop a disease-specific health-related quality of life (HRQL) measure, the deep venous thrombosis quality of life questionnaire (DVTQOL), for patients with recent exposition and treatment of proximal deep venous thrombosis. METHODS: A total of 121 consecutive outpatients (50 % males; mean age 61.2 ± 14 years) treated with warfarin (Waran(®)) for symptomatic proximal deep venous thrombosis were included in the study. Patients completed the SF-36, EQ-5D and the pilot version of the DVTQOL. RESULTS: Items having: high ceiling and floor effect, items with lower factor loadings than 0.50 and items loading in several factors were removed from the pilot version of DVTQOL. In addition, overlapping and redundant items identified by the Rasch analysis were excluded. The final DVTQOL questionnaire consists of 29 items composing six dimensions depicting problems with: emotional distress; symptoms (e.g. pain, swollen ankles, cramp, bruising); limitation in physical activity; hassle with coagulation monitoring; sleep disturbance; and dietary problems. The internal consistency reliability was high (alpha value ranged from 0.79 to 0.93). The relevant domains of the SF-36 and EQ-5D significantly correlated with DVTQOL, thereby confirming its construct validity. CONCLUSIONS: The DVTQOL is a short and user-friendly instrument with good reliability and validity. Its test-retest reliability and responsiveness to change in clinical trials, however, must be explored

Impact of gastroesophageal reflux disease on patients' daily lives: a European observational study in the primary care setting

<p>Abstract</p> <p>Background</p> <p>The impact of gastroesophageal reflux disease (GERD) on the daily lives of patients managed in primary care is not well known. We report the burden of GERD in a large population of patients managed in primary care, in terms of symptoms and impact on patients' daily lives.</p> <p>Methods</p> <p>RANGE (<it>R</it>etrospective <it>AN</it>alysis of <it>GE</it>RD) was an observational study that was conducted at 134 primary care sites across six European countries. All adult subjects who had consulted their primary care physician (PCP) during a 4-month identification period were screened retrospectively and those consulting at least once for GERD-related reasons were identified. From this population, a random sample of patients was selected to enter the study and attended a follow-up appointment, during which the Reflux Disease Questionnaire (RDQ), the GERD Impact Scale (GIS) and an extra-esophageal symptoms questionnaire were self-administered. Based on medical records, data were collected on demographics, history of GERD, its diagnostic work-up and therapy.</p> <p>Results</p> <p>Over the 4-month identification period, 373,610 subjects consulted their PCP and 12,815 (3.4%) did so for GERD-related reasons. From 2678 patients interviewed (approximately 75% of whom reported taking medication for GERD symptoms), symptom recurrence following a period of remission was the most common reason for consultation (35%). At the follow-up visit, with regard to RDQ items (score range 0–5, where high score = worse status), mean Heartburn dimension scores ranged from 0.8 (Sweden) to 1.2 (UK) and mean Regurgitation dimension scores ranged from 1.0 (Norway) to 1.4 (Germany). Mean overall GIS scores (range 1–4, where low score = worse status) ranged from 3.3 (Germany) to 3.5 (Spain). With regard to extra-esophageal symptoms, sleep disturbance was common in all countries in terms of both frequency and intensity.</p> <p>Conclusion</p> <p>In this large European observational study, GERD was associated with a substantial impact on the daily lives of affected individuals managed in the primary care setting.</p