Development of a neonatal adverse event severity scale through a Delphi consensus approach.

BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. METHODS: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. RESULTS: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.

Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study.

INTRODUCTION: When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions experienced in free-text format. Recently, a patient-friendly adverse drug reaction terms list was introduced in the adverse drug reaction report form in the UK to facilitate this reporting. OBJECTIVE: The objective of this study was to evaluate the actual use of the patient-friendly terms list in the adverse drug reaction report form and its association with the type of adverse drug reactions reported. METHODS: We conducted a database study in which we reviewed the list's use for all reported adverse drug reactions by patients and consumers to the pharmacovigilance centre in the UK via the online report form between August and September 2017. Descriptive statistics were used. In addition, for adverse drug reactions reported more than 20 times, Chi-squared tests were used to test for differences in the number of reports in which the patient-friendly terms list was used and those in which the adverse drug reaction was entered as free text. RESULTS: In total, 888 reports were received. In 185 reports (21%), the patient-friendly terms list was used to enter an adverse drug reaction. In total, the reports contained 3227 adverse drug reactions. Nausea, headache, diarrhoea, dizziness, insomnia, anxiety, depression, fatigue, tiredness, vomiting, appetite lost, joint pain, chest pain, constipation and pain were reported more than 20 times. Five of these adverse drug reactions (i.e. nausea, diarrhoea, dizziness, insomnia and constipation) were reported significantly more often in reports where the adverse drug reactions were selected from the patient-friendly terms list. CONCLUSIONS: Most people chose to describe adverse drug reactions in their own words rather than selecting adverse drug reactions from a patient-friendly terms list. Although the patient-friendly terms list may be a useful feature for some patients or for some adverse drug reactions, it should not replace the option for patients to describe adverse drug reactions in their own words.

Survey of food safety practices on small to medium-sized farms and in farmers markets.

As produce consumption has increased, so have foodborne disease outbreaks associated with fresh produce. Little research has addressed food safety practices used on small to medium-sized farms selling locally or in farmers markets. This study evaluated current food safety practices used by farmers on small to medium-sized farms and managers of farmers markets in Georgia, Virginia, and South Carolina based on responses to surveys. Surveys were developed, pretested, and revised before implementation with target audiences and were implemented via mail and the Web to maximize participation, with reminders sent to nonrespondents. Data were collected from 226 farmers and 45 market managers. Frequencies and percentages were calculated for all response variables. Responses from farmers indicated that more than 56% of them use manures. Of those who use manures, 34% use raw or mixtures of raw and composted manure, and over 26% wait fewer than 90 days between application of raw manure and harvest. Over 27% use water sources that have not been tested for safety for irrigation, and 16% use such water sources for washing produce. Over 43% do not sanitize surfaces that touch produce at the farm. Only 33% of farmers always clean transport containers between uses. Responses from market managers indicated that over 42% have no food safety standards in place for the market. Only 2 to 11% ask farmers specific questions about conditions on the farm that could affect product safety. Less than 25% of managers sanitize market surfaces. Only 11% always clean market containers between uses. Over 75% of markets offer no sanitation training to workers or vendors. While farmers and market managers are using many good practices, the results indicate that some practices being used may put consumers at risk of foodborne illness. Consequently, there is a need for training for both farmers and market managers.

In vitro and in vivo antibacterial activities of cranberry press cake extracts alone or in combination with ß-lactams against Staphylococcus aureus.

BACKGROUND: Cranberry fruits possess many biological activities partly due to their various phenolic compounds; however the underlying modes of action are poorly understood. We studied the effect of cranberry fruit extracts on the gene expression of Staphylococcus aureus to identify specific cellular processes involved in the antibacterial action. METHODS: Transcriptional profiles of four S. aureus strains grown in broth supplemented or not with 2 mg/ml of a commercial cranberry preparation (Nutricran®90) were compared using DNA arrays to reveal gene modulations serving as markers for biological activity. Ethanol extracted pressed cakes from fresh fruits also produced various fractions and their effects on marker genes were demonstrated by qPCR. Minimal inhibitory concentrations (MICs) of the most effective cranberry fraction (FC111) were determined against multiple S. aureus strains and drug interactions with ß-lactam antibiotics were also evaluated. Incorporation assays with [(3)H]-radiolabeled precursors were performed to evaluate the effect of FC111 on DNA, RNA, peptidoglycan (PG) and protein biosynthesis. RESULTS: Treatment of S. aureus with Nutricran®90 or FC111 revealed a transcriptional signature typical of PG-acting antibiotics (up-regulation of genes vraR/S, murZ, lytM, pbp2, sgtB, fmt). The effect of FC111 on PG was confirmed by the marked inhibition of incorporation of D-[(3)H]alanine. The combination of ß-lactams and FC111 in checkerboard assays revealed a synergistic activity against S. aureus including strain MRSA COL, which showed a 512-fold drop of amoxicillin MIC in the presence of FC111 at MIC/8. Finally, a therapeutic proof of concept was established in a mouse mastitis model of infection. S. aureus-infected mammary glands were treated with amoxicillin, FC111 or a combination of both; only the combination significantly reduced bacterial counts from infected glands (P<0.05) compared to the untreated mice. CONCLUSIONS: The cranberry fraction FC111 affects PG synthesis of S. aureus and acts in synergy with ß-lactam antibiotics. Such a fraction easily obtained from poorly exploited press-cake residues, may find interesting applications in the agri-food sector and help reduce antibiotic usage in animal food production.

Sanitizer efficacy against murine norovirus, a surrogate for human norovirus, on stainless steel surfaces when using three application methods.

Human noroviruses are major etiologic agents of epidemic gastroenteritis. Outbreaks are often accompanied by contamination of environmental surfaces, but since these viruses cannot be routinely propagated in laboratory cultures, their response to surface disinfectants is predicted by using surrogates, such as murine norovirus 1 (MNV-1). This study compared the virucidal efficacies of various liquid treatments (three sanitizer liquids, 5% levulinic acid plus 2% SDS [LEV/SDS], 200 ppm chlorine, and an isopropanol-based quaternary ammonium compound [Alpet D2], and two control liquids, sterile tap water and sterile tap water plus 2% SDS) when delivered to MNV-1-inoculated stainless steel surfaces by conventional hydraulic or air-assisted, induction-charged (AAIC) electrostatic spraying or by wiping with impregnated towelettes. For the spray treatments, LEV/SDS proved effective when applied with hydraulic and AAIC electrostatic spraying, providing virus reductions of 2.71 and 1.66 log PFU/ml, respectively. Alpet D2 provided a 2.23-log PFU/ml reduction with hydraulic spraying, outperforming chlorine (1.16-log PFU/ml reduction). Chlorine and LEV/SDS were equally effective as wipes, reducing the viral load by 7.05 log PFU/ml. Controls reduced the viral load by <1 log with spraying applications and by >3 log PFU/ml with wiping. Results indicated that both sanitizer type and application methods should be carefully considered when choosing a surface disinfectant to best prevent and control environmental contamination by noroviruses.

Safe Eats: an evaluation of the use of social media for food safety education.

Many undergraduate students are cooking for the first time, and they need to learn safe food practices to reduce their risk of foodborne illness. Social media tools are being utilized to disseminate public health messages, but limited research has been conducted to examine the effectiveness of these tools for food safety education. The purpose of this study was to develop and evaluate a social media-based intervention for young adults to improve food safety attitudes, practices, and knowledge. Preliminary surveys were conducted and online focus groups were convened to guide design of this social media intervention. College students (710) were included in treatment and control groups. Results from pretests and posttests indicate that participation in the "Safe Eats" Facebook intervention leads to improvements in food safety attitudes, practices, and knowledge. Although students reported that they learned more from the intervention than from a traditional lecture, the combination of lecture and Facebook resulted in higher knowledge scores than those resulting from the intervention alone. Participants who spent more time on the Facebook page had greater improvements in food safety attitudes and practices.

Certified kitchen managers: do they improve restaurant inspection outcomes?

Restaurants are associated with a significant number of foodborne illness outbreaks in the United States. Certification of kitchen managers through an accredited training and testing program may help improve food safety practices and thus prevent foodborne illness. In this study, relationships between the results of routine restaurant inspections and the presence of a certified kitchen manager (CKM) were examined. We analyzed data for 4461 restaurants in Iowa that were inspected during 2005 and 2006 (8338 total inspections). Using logistic regression analysis, we modeled the outcome variable (0 = no critical violations [CVs]; 1 = one or more CVs) as a function of presence or absence of a CKM and other explanatory variables. We estimated separate models for seven inspection categories. Restaurants with a CKM present during inspection were less likely to have a CV for personnel (P < 0.01), food source or handling (P < 0.01), facility or equipment requirements (P < 0.05), ware-washing (P < 0.10), and other operations (P < 0.10). However, restaurants with a CKM present during inspection were equally likely to have a CV for temperature or time control and plumbing, water, or sewage as were restaurants without a CKM present. Analyses by type of violation within the temperature and time control category revealed that restaurants with a CKM present during inspection were less likely to have a CV for hot holding (P < 0.05), but the presence of a CKM did not affect other types of temperature and time control violations. Our analyses suggest that the presence of a CKM is protective for most types of CVs, and we identify areas for improving training of CKMs.

Listeria monocytogenes survival in refrigerator dill pickles.

Listeria monocytogenes can survive and grow in refrigerated foods with pH values of approximately 4.0 to 5.0 and salt concentrations of 3 to 4%. Home-fermented refrigerator dill pickles fit this description. Contamination of this product with L. monocytogenes could cause serious problems because these items are not heated prior to consumption. L. monocytogenes survival and growth patterns were investigated in refrigerator dill pickles at 1.3, 3.8, and 7.6% salt concentrations. Pickling cucumbers were dipped into an inoculum of L. monocytogenes, brine mixtures were added, and cucumbers were held at room temperature for 1 week and then refrigerated for up to 3 months. The pH, NaCl percentage, titratable acidity percentage, and total populations of Listeria and aerobic, psychrotrophic, and lactic acid bacteria were measured at the addition of brine, after 2, 4, and 7 days of storage at room temperature, and then weekly during refrigerated storage. The initial Listeria population was 5.4 to 5.6 log CFU/cm2 on cucumber surfaces and 3.9 to 4.6 log CFU/g internally. There was an approximate 0.3- to 1-log increase during room temperature fermentation followed by a population decline during refrigerator storage, with a greater decrease in the brines with the highest NaCl concentration. Up to 49 days, the internal tissue of pickles with 1.3, 3.8, or 7.6% salt concentrations were presumptively positive for L. monocytogenes by the enrichment method, and at 91 days the surfaces of such pickles were still positive for L. monocytogenes. Populations of total aerobes and lactic acid bacteria increased during room temperature storage and decreased gradually during refrigerated storage.

An investigation into adult nursing students' experience of the relevance and application of behavioural sciences (biology, psychology and sociology) across two different curricula.

Curriculum development for nurse education is constantly changing to reflect the sociopolitical context and medical advancement. Throughout this process the contribution of the behavioural sciences to each curriculum has been widely debated. Nurse educators encourage students to acquire and develop academic knowledge to underpin their practical skills and professional competencies. However with new political agendas science content within the new curricula is being marginalised, [United Kingdom Central Council for Nursing Midwifery and Health Visiting, 1999. Fitness for Practice. London, UKCC]. This qualitative study investigated adult branch nursing students' experiences of the behavioural sciences while studying two different curricula: one a new integrated delivery of the sciences, the other involving discrete science modules. The study utilised focus group interviews at two distinct phases of their courses: 12-18 and 24-30 months. Each interview was tape recorded, transcribed verbatim and inductive thematic analysis [Hayes, N., 1997. Doing Qualitative Analysis in Psychology. Psychology Press Erlbaum Taylor & Francis Ltd.] was applied. This article reports the findings and discusses the relevance of the sciences to students and their patient care, and how the sciences underpin their view of health and illness.

Effects of preparation methods on the microbiological safety of home-dried meat jerky.

Historically, drying meats to produce jerky was conisidered to be a safe preservation process and the convenience and flavor of jerky has made it a popular food product for home food preservers. Recent outbreaks of foodborne illness related to both home-dried and commercially manufactured jerky have raised concerns about the safety of the product. Some traditional home recipes and drying processes were shown to be inadequate to destroy Escherichia coli O157, Salmonella, Staphylococcus aureus, and Listeria monocytogenes in both whole-muscle and ground-meat jerky. Several research studies have identified processes such as precooking meats before drying, usingacidic marinades, cooking meats after drying, or some combination of these treatments that can destroy pathogens of concern to produce microbiologically safe and palatable meat jerky at home.

Day hospital vs. home treatment--a comparison of illness severity and costs.

BACKGROUND: Acute home treatment services, providing short-term intensive input as an alternative to in-patient admission, have been recommended by the Department of Health as part of a spectrum of care. The lack of research evidence for such services is in contrast to acute day hospital care which has been better researched, but not widely adopted. This paper compares the patients treated in a randomised controlled trial (RCT) of day hospital vs. in-patient care with patients treated several years later in the home treatment service which developed from the original acute day hospital. METHOD: In the original RCT, patients were randomised at the point of admission to day hospital or in-patient care. The home treatment sample consisted of a consecutive series of admissions. Severity of illness was assessed at admission using the Comprehensive Psychopathological Rating Scale (CPRS). Both samples were followed up for 12 months to monitor service use and costs. RESULTS: Symptom severity among the home treatment sample (n = 71) was greater than the day hospital sample (n = 94) (mean CPRS score 31.6 vs. 25.5, p < 0.0001). This difference remained significant following adjustment for other socio-demographic and illness variables. Secondary care costs for the home treatment sample (including in-patient, home treatment and out-patient costs) were intermediate between the costs for the day hospital and in-patient samples from the RCT, but the differences were not statistically significant. CONCLUSIONS: Extending the remit of an acute day hospital to provide 24-h care and a choice of treatment location is associated with an increase in the severity of illness treated. The impact on costs is unclear and the total cost of the new service may not be significantly less than in-patient care. The results need to be interpreted with caution because of differences in recruitment methods.

Interventions and outcomes of health and social care service provision for people with severe mental illness in England.

BACKGROUND: Mental health policy in England is undergoing radical change involving the integration of services aimed at improving outcomes for patients. At the same time, there is limited evidence about how conventional services are performing. The present paper reports data on the services provided and short-term outcomes achieved in eight community services in England. METHOD: A survey of caseloads of nurses and social workers was undertaken using a single-page assessment tool (MARC1) (n = 3024). After 5 months a random sample of psychotic cases was followed up (n = 393). RESULTS: A tendency was observed for health and social care practitioners to use the services available from within their own organisation. Over time, in the most severe cases, there was a substantial increase in provision of the services of the other organisation. Outcomes in terms of changes in HoNOS, GAS and MARC1 scores were similar for both professional groups, and both reported similar amounts of met and unmet need (and in the same categories) at follow-up. CONCLUSION: The most likely explanation for the change in service provision is the separate operation of different professional groups acting as gatekeepers for their own resources.

Fate of Listeria monocytogenes and Salmonella Species in Ground Beef Jerky.

Home-style drying procedures used for jerky made from whole meat strips may be insufficient to eliminate bacterial pathogens from jerky made from ground meat due to the possible distribution of pathogens throughout the product. The fate of Listeria monocytogenes and Salmonella species during preparation of ground beef jerky was determined. Ground beef was inoculated with these pathogens to a level of approximately 106 CFU/g prior to drying. A drying method shown to reduce the population of these microorganisms by 5 log CFU/g on jerky made with beef loin strips in a home-style dehydrator maintained at 60°C (140°F) was used with unheated samples and samples heated to 71.1°C (160°F) prior to drying, with and without cure mix. Populations of each pathogen type were determined after 0, 2, 4, 6 and 8 h of drying. In unheated samples without cure mix, there was only a 2.5 to 4 log reduction in the pathogens after 8 h of drying. When cure mix was added, the populations were reduced by at least 4 logs. Population reductions in heated samples without cure were approximately 3.8 log CFU/g for Salmonella and Listeria . Addition of the cure mix resulted in a greater reduction in Salmonella populations in the heated samples.

Fate of Escherichia coli O157:H7, Listeria monocytogenes , and Salmonella typhimurium during Preparation and Storage of Beef Jerky.

The fate of Escherichia coli O157:H7, Listeria monocytogenes , and Salmonella typhimurium during preparation and storage of beef jerky was determined. Control strips and one-half of the inoculated beef loin strips were marinated at 4°C overnight and dried at 60°C (140°F) for 10h. The remaining half of the inoculated samples were heated in marinade to 71.1°C (160°F). Strips were dried at 60°C (140°F) for 10 h. Microbial populations were determined at intervals during drying up to 10 h and also from samples stored at 25°C for 8 weeks at various moisture levels. In general, L. monocytogenes was more resistant to the treatments. After 3 h of drying, populations on the unheated, inoculated samples were reduced by 3.3, 1.8 and 3.1 log units, respectively, and all three were reduced by 5.5 to 6.0 log units after 10h. Reduction of the three populations on strips that were cooked prior to drying was 4.5 to 5.5 log units immediately after cooking. The populations decreased to undetectable levels after 10 h of drying. None of the three pathogens were detected on the controls. After 8 weeks of storage none of the pathogens were detected, indicating that they were unable to recover under the moisture conditions during storage.