Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients.

Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.

Population structure and diversity assessment of barley (Hordeum vulgare L.) introduction from ICARDA.

This study was undertaken to measure the genetic diversity and population structure of 48 barley accessions introduced from ICARDA using 51 polymorphic simple sequence repeat (SSR) markers to select unique parents for breeding. The mean polymorphic information content was 0.491, suggesting high polymorphism for the selected SSR markers among the barley accessions. The population structure indicated a fine genetic base only with two major clusters. All accessions had 100% membership probability in their respective clusters. Analysis of molecular variance revealed that most (78%) of the variation was attributed between populations, while 22% was due to variation among individuals within populations. Neighbour-joining (NJ) tree was constructed using this distance matrix and two major clusters were observed in it. Cluster 1 had all hulled barley accessions and cluster 2 had all hulless barley accessions. Cluster 2 could be further divided into three subclusters. Principal coordinates analysis results were similar to the NJ tree, where the hulled and hulless barley accessions were grouped into separate clusters. This study established the existence of considerable genetic diversity among the 48 tested accessions. The selected genetic resources will be useful for barley breeding in India and other countries.

Assessment of the inferior mesenteric vein diameter as a surrogate marker to evaluate response to neoadjuvant chemoradiotherapy for locally advanced rectal adenocarcinoma.

AIM: Neoadjuvant chemoradiotherapy for locally advanced rectal cancer aims to downstage prior to definitive management. Repeat imaging assessment of the tumour post-therapy has implications for treatment. Our aim was to assess if the inferior mesenteric vein (IMV) diameter measured on CT can be used as a surrogate marker for evaluation of tumour response to neoadjuvant treatment. METHOD: IMV diameter was assessed in patients with and without locally advanced rectal cancer, pre- and post-radiotherapy, to ascertain if IMV diameter is a surrogate marker of tumour response. RESULTS: IMV diameter was 5.9 mm in patients with rectal cancer vs 4.7 mm in patients without (P = 0.0001). The baseline IMV diameter was significantly higher for cases with local lymphadenopathy [N0 5.2 mm vs N1/2 6 mm (P = 0.0059)] and extramural venous invasion (EMVI) [negative 5.4 mm vs positive 6.4 mm (P = 0.0001)]. Post-radiotherapy there was a significant decrease in the IMV diameter in cases with treatment response compared to non-responders: the percentage change in IMV diameter was a 17.54% decrease vs 1.39% increase (P = 0.0001). These results were reproduced on comparing between magnetic resonance tumour regression grades using ANOVA (P = 0.0001). There was also a significant decrease in IMV diameter when assessing lymph node (LN) and EMVI response vs non-responders (P = 0.0001 and 0.0001 respectively). CONCLUSION: Patients with rectal cancer have a dilated IMV compared with patients without rectal cancer. We confirm that IMV diameter is a potential surrogate marker of LN status and EMVI at baseline. IMV diameter is also a marker of tumour, LN and EMVI response to chemoradiotherapy.

Outcome assessment in conservatively managed patients with cervical spine tuberculosis.

STUDY DESIGN: Cervical spine tuberculosis is a relatively less frequent form of spinal tuberculosis. Cervical spine tuberculosis has a greater propensity to involve the spinal cord and results in major sensory motor deficit. In this prospective study, we aimed to evaluate the clinical and imaging predictors of outcome in conservatively managed patients. METHODS: In this study, 42 patients of cervical spine tuberculosis were included. Patients were subjected to a detailed clinical evaluation and magnetic resonance imaging. Patients were treated with antituberculosis treatment and were followed up for 18 months. The Modified Barthel index (MBI) was used to assess the disability. Good outcome was defined as MBI >12 and poor outcome as MBI ⩽12. Clinical and imaging characteristics were used to analyze the predictors of outcome, using univariate and multivariate analysis. RESULTS: Four (9.5%) patients required surgery. Data from 38 patients, who were conservatively managed, were analyzed for predictors of outcome. Among conservatively managed patients, at presentation, 29 patients had an MBI score of ⩽12. At 18 months, the majority of patients (81.6%) had a good outcome. On univariate analysis, a duration of illness >3 months, a major motor deficit, bladder involvement, flexor spasms, significant cord compression and spinal extension of the abscess were significantly associated with a poor outcome. However, on multivariate analysis significant cord compression (P=0.003) and spinal extension (P=0.02) showed a significant correlation with a poor outcome. CONCLUSION: Medical management was effective in cervical spine tuberculosis. Patients with significant cord compression and spinal extension of the abscess showed poorer outcome.

Does reporting of plain chest radiographs affect the immediate management of patients admitted to a medical assessment unit?

AIM: The purpose of our study was to investigate whether reporting of plain chest radiographs affects immediate management of patients admitted to a medical assessment unit. MATERIALS AND METHODS: During a 3 month period we prospectively evaluated 200 patients who had a plain chest radiograph on admission. After the post on-call ward round, an independent medical specialist registrar reviewed the notes, retrieving relevant clinical details. The plain chest films were reported independently by a trainee radiologist and consultant, reaching a consensus report. RESULTS: There was 93% agreement between trainee and consultant radiologists (95% CI=89-96%). Seventy percent had documented reports by the on-call medical team. There was disagreement between radiology and medical reports in 49% of reported films (95% CI=40-57%). The radiologist's report led to a direct change in the immediate management of 22 patients (11%). CONCLUSION: Only 70% of films had documented reports in the clinical notes despite this being a legal requirement. Radiology reporting does cause a direct change in patient management. Chest radiographs of patients admitted to a medical admissions unit should be reported by a radiologist with the minimum of delay.

Life cycle of a data warehousing project in healthcare.

Hill Physicians Medical Group (and its medical management firm, PriMed Management) early on recognized the need for a data warehouse. Management demanded that data from many sources be integrated, cleansed, and formatted. As a first step, an operational data store (ODS) was built and populated with data from the main transactional system; encounter data were added. The ODS has served its purpose well and has whetted management's appetite for more information and faster, more reliable access, all in one location. PriMed hired Annams Systems Consulting (Annams) for this effort. A team was formed, made up of consultants from Annams and members of PriMed's information services (IS) team. The "classical" approach is being taken: enhancing the ODS, which is largely normalized in structure, and integrating data from various sources, along with enforcing business rules. The team is designing and implementing data marts and a "star schema" style of data modeling--a useful tool for management to evaluate results before investing further.

Assessment of mouth-to-mask ventilation in resuscitation of asphyxic newborn babies. A pilot study.

The aim of the study was to compare the effectiveness of mouth-to-mask ventilation (MM) in neonatal asphyxia with bag-and-mask ventilation (BM). A new mouth-to-mask infant resuscitation system was constructed. The study was performed in two university clinics with different resources. The KEM Hospital in Bombay was well equipped and neonatologists took part in all resuscitations; Muhimbili Medical Centre in Dar es Salaam was understaffed and had no physicians available at resuscitation. Therefore, different protocols had to be used. In Bombay, the study period was limited to 5 minutes. If needed, mask ventilation was then replaced by intubation. In Dar es Salaam, MM ventilation was continued for up to 10 minutes, the inspiratory pressure was adjusted to 30 cmH2O and the ventilation was slow (8-10 breaths/min). In Bombay, 30 babies were allocated to the BM and 24 to the MM groups. In Dar es Salaam 56 were in the BM and 64 in the MM groups. The results for term babies in Bombay and both term and pre-term babies in Dar es Salaam showed no significant differences between the two groups of treatment, as determined by Apgar score > or = 4 at 5 and 10 minutes, number of babies with their first gasp, heart rate > 130 beats/min or pulse oximeter values above 75%, all at 5 minutes. An Apgar score > or = 4 at 5 minutes was achieved in more than 75% of all infants, irrespective of treatment. The rates of early neonatal mortality and neonatal convulsions did not differ between the two methods of resuscitation. In Dar es Salaam, the low respiratory frequency used in both groups was associated with a slow increase in heart rate above 130 beats per min. This result indicates that further studies will be needed before such slow respiratory frequencies are used. We conclude that, if adequate training is provided and the respiratory frequency is kept within the normal range, MM ventilation is an alternative to assisted ventilation when no bag and mask is available. However, further studies are necessary, since this method has proved to be tiring and uncomfortable for the resuscitating health personnel.

Employment income of immigrants in metropolitan areas of Canada, 1980.

PIP: This paper examines the economic achievements of immigrant groups and compares them with those of the Canadian-born population. Employment income in this study is income for members of the labor force who worked 40 weeks or more, full time, during 1980. The information is from the 1981 Census. The 15 birthplace groups considered in this study are classified into 2 major groups: those from traditional sources and those from non-traditional or new sources. Traditional sources are the US, UK, and Europe. The new sources are Africa, Asia, South and Central America, the Caribbean, and Oceania. More than 1/2 of the immigrants from traditional sources arrived before 1960, whereas more than 1/2 of immigrants from new sources arrived after 1970. The analysis is only for those areas called Census Metropolitan Areas. Results of analysis show that 1) immigrant men and women in metropolitan areas earned 1.9% and 5.9% respectively less than their Canadian-born counterparts; 2) when differences in age and educational attainment were considered, incomes of immigrant men and women were about 7.5% below those of their Canadian-born counterparts; 3) the new immigrant groups earned far less than those of the Canadian-born counterparts; 4) traditional-source immigrants' incomes were equal to or slightly higher than Canadians'; and 5) as length of residence increases, most immigrant groups improve their relative economic position and achieve incomes comparable to Canadians'. The authors discuss the economic adaptation of immigrants in the light of various models: assimilation, Marxist class conflict, ethnic stratification and segmentation, structural pluralism, and structural change. No theory can be applied to the economic adaptation of all types of immigrants. Finally, refugees and sponsored relatives, who are not admitted on the basis of education and occupational need, are likely to have more difficulties than independent immigrants.^ieng

Socio-cultural factors affecting breast feeding and other infant feeding practices in an urban community.

PIP: A study of infant feeding practices was carried out as part of a larger longitudinal study of an urban birth cohort in an area of South Delhi, India. 802 mothers of children over 1 year of age were selected randomly for interview. The study group is considered to be a representative sampling of the economic, cultural, and ethnic groups within the population of all of Delhi. Breast feeding was almost universal but for varying durations. 5.5%, 11.7%, and 22.8% of the children were breast fed for less than 1 month, 2 months, and 6 months respectively. Literate and older mothers tended to breast feed for shorter periods of time. Illiterate mothers, on the other hand, tended to prolong breast feeding unduly. The sex of the infant and the duration of the urban stay of the mother did not seem to affect the duration of breast feeding. Supplementation with liquid feeds, 50% diluted buffalo milk in the majority of cases, was begun rather early but the introduction of semisolids and solids was very often unduly delayed. This was particularly true among illiterate mothers. Thus, it is felt that a concerted effort to educate mothers, especially illiterate and underprivileged mothers, regarding the role of breast feeding and the benefits of supplementation feeding would improve infant nutritional status.^ieng