Background: In Korea, every vaccine lot is tested by the National Center for Lot Release (NCLR) in accordance with the national lot release procedures to ensure the safety and efficacy of vaccines. These quality tests examine the virus content in varicella vaccines via plaque assays (either the agar overlay method [AOM] or plaque staining method [PSM]), according to the procedures suggested by the Korean Reference Material for the Varicella Vaccine (KRMVV) or the manufacturer’s standard in-house protocol.AimTo standardize the virus content tests, viral titers in the KRMVV were measured using the PSM at four participating laboratories in a collaborative study. With the aim of developing a standardized method using the KRMVV as a positive control, we compared the ability of the two test methods, AOM and PSM, to accurately and reproducibly determine the virus content of two commercial varicella vaccines. Results: The results showed that the standardized method (PSM) was more suitable for quality control analysis of the varicella vaccine. Conclusion: Use of a standardized method (PSM) according to the Korean reference material will improve the reliability and objectivity of lot release testing.
Background: Survival from cancer is worse in England than in some European countries. To improve survival, strategies in England have focused on early presentation (reducing delay to improve stage at diagnosis), improving quality of care and ensuring equity throughout the patient pathway. We assessed whether primary care characteristics were associated with later stage cancer at diagnosis (stages 3/4 versus 1/2) for female breast, lung, colorectal and prostate cancer. Methods: Data obtained from the National Cancer Registration Service, Quality Outcomes Framework, GP survey and GP workforce census, linked by practice code. Risk differences (RD) were calculated by primary care characteristics using a generalised linear model, accounting for patient clustering within practices. Models were adjusted for age, sex and an area-based deprivation measure. Results: For female breast cancer, being with a practice with a higher two week wait (TWW) referral rate (RD −1.8 % (95 % CI −0.5 % to −3.2 %) p = 0.003) and a higher TWW detection rate (RD −1.7 % (95 % CI −0.3 % to −3.0 %) p = 0.003) was associated with a lower proportion diagnosed later. Being at a practice where people thought it less easy to book at appointment was associated with a higher percentage diagnosed later (RD 1.8 % (95 % CI 0.2 % to 3.4 %) p = 0.03). For lung cancer, being at practices with higher TWW referral rates was associated with lower proportion advanced (RD-3.6 % (95 % CI −1.8 %, −5.5 %) p < 0.001) whereas being at practices with more patients per GP was associated with higher proportion advanced (RD1.8 % (95 % CI 0.2, 3.4) p = 0.01). A higher rate of gastrointestinal investigations was associated with a lower proportion of later stage colorectal cancers (RD −2.0 % (95 % CI −0.6 % to −3.6 %) p = 0.01). No organisational characteristics were associated with prostate cancer stage. Conclusion: Easier access to primary care, faster referral and more investigation for gastrointestinal symptoms could reduce the proportion of people diagnosed later for female breast, lung and colorectal, but not prostate cancer. Differences between the four main cancers suggest different policies may be required for individual cancers to improve outcomes.
Background: Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient’s motivation and maintenance of self-management behaviours can be positively influenced by the clinician’s use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. Methods: A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. Results: Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. Conclusion: The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.
Background: Excessive daytime sleepiness (EDS) has been associated with an increased risk for falls among clinical samples of older adults. However, there is little detailed information among population-representative samples. The current study aimed to assess the relationship between EDS and falls among a cohort of population-based older adults. Methods: This study assessed 367 women aged 60-93years (median 72, interquartile range 65-79) and 451 men aged 60-92years (median 73, interquartile range 66-80) who participated in the Geelong Osteoporosis Study between the years 2001 and 2008. Falls during the prior year were documented via self-report, and for men, falls risk score was obtained using an Elderly Fall Screening Test (EFST). Sleepiness was assessed using the Epworth Sleepiness Scale (ESS), and scores of ≥ 10 indicated EDS. Differences among those with and without EDS in regard to falls were tested using logistic regression models. Results: Among women, 50 (13.6 %) individuals reported EDS. Women with EDS were more likely to report a fall, and were more likely to report the fall occurring outside. EDS was similarly associated with an increased risk of a fall following adjustment for use of a walking aid, cases of nocturia and antidepressant medication use (adjusted OR = 2.54, 95 % CI 1.24-5.21). Multivariate modelling revealed antidepressant use (current) as an effect modifier (p < .001 for the interaction term). After stratifying the data by antidepressant medication use, the association between EDS and falls was sustained following adjustment for nocturia among antidepressant non-users (adjusted OR = 2.63, 95 % CI 1.31-5.30). Among men, 72 (16.0 %) individuals reported EDS. No differences were detected for men with and without EDS in regard to reported falls, and a trend towards significance was noted between EDS and a high falls risk as assessed by the EFST (p = 0.06), however, age explained this relationship (age adjusted OR = 2.20, 95 % CI 1.03-1.10). Conclusions: For women, EDS is independently associated with at least one fall during the previous year, and this is more likely to occur whilst located outside. Amelioration of EDS may assist in improving functional outcomes among these individuals by reducing the risk for falls.
Background: MicroRNAs (miRNAs) show differential expression across breast cancer subtypes and have both oncogenic and tumor-suppressive roles. Numerous microarray studies reported different expression patterns of miRNAs in breast cancers and found clinical interest for several miRNAs but often with contradictory results. Aim of this study is to identify miRNAs that are differentially expressed in estrogen receptor positive (ER + ) and negative (ER − ) breast primary tumors to better understand the molecular basis for the phenotypic differences between these two sub-types of carcinomas and to find potential clinically relevant miRNAs. Methods: We used the robust and reproductive tool of quantitative RT-PCR in a large cohort of well-annotated 153 breast cancers with long-term follow-up to identify miRNAs specifically differentially expressed between ER + and ER − breast cancers. Cytotoxicity tests and transfection experiments were then used to examine the role and the regulation mechanisms of selected miRNAs. Results: We identified a robust collection of 20 miRNAs significantly deregulated in ER + compared to ER − breast cancers : 12 up-regulated and eight down-regulated miRNAs. MiR-190b retained our attention as it was the miRNA the most strongly over-expressed in ER + compared to ER − with a fold change upper to 23. It was also significantly up-regulated in ER + /Normal breast tissue and down-regulated in ER − /Normal breast tissue. Functional experiments showed that miR-190b expression is not directly regulated by estradiol and that miR-190b does not affect breast cancer cell lines proliferation. Expression level of miR-190b impacts metastasis-free and event-free survival independently of ER status. Conclusions: This study reveals miR-190b as the highest up-regulated miRNA in hormone-dependent breast cancers. Due to its specificity and high expression level, miR-190b could therefore represent a new biomarker in hormone-dependent breast cancers but its exact role carcinogenesis remains to elucidate.
Background: Aspiration pneumonia is an important cause of morbidity and mortality in Parkinson’s disease (PD). Clinical characteristics of PD patients in addition to specific alterations in swallowing mechanisms contribute to higher swallowing times and impairment in the effective clearance of the airway. These issues may render patients more prone to dysphagia and aspiration events. We aimed to determine the frequency of aspiration events in a hospitalized PD cohort, and to report the number of in-hospital swallow evaluations. Methods: A retrospective single center chart review of 212 PD patients who had 339 hospital encounters was performed from January 2011 to March 2013. Demographics, clinical characteristics, and reasons for encounters were documented. The number of in-hospital aspiration events and the number of swallowing evaluations and also the implementation of aspiration precautions were recorded. Results: The cohort had a mean age of 74.1 (SD = 10.1) years with mean disease duration of 6 (SD = 6.3) years. Fifty-two hospital encounters (15.3 %) were related to a pulmonary cause. In-hospital aspiration pneumonia events were reported in 8 (2.4 %) of the total encounters. Swallow evaluations were performed in 25 % of all cases, and aspiration precautions were initiated in 32 % of the encounters. The data revealed that 1/8 patient had swallowing evaluations performed prior to an aspiration event. Conclusions: In-hospital aspiration pneumonia events were reported in 2.4 % of the hospitalized PD cohort. Preventive measures and precautions were not routinely performed, however rates of aspiration were relatively low. The results highlight the need for more research into screening and monitoring of swallowing problems in PD patients during hospital encounters.
Background: Tobacco consumption is a major risk factor for morbidity and mortality. The Saudi Ministry of Health started a national tobacco control program in 2002 with increased and intensified efforts after joining the World Health Organization Framework Convention for Tobacco Control in 2005. Methods: In order to assess the status of tobacco consumption in the Kingdom of Saudi Arabia (KSA), we conducted a survey on 10735 individuals aged 15 years or older (5253 men and 5482 women) which was performed between April and June 2013. The Saudi Health Interview Survey had a multistage sampling and was nationally representative. Data were collected through face-to-face interviews. The survey included questions on socio-demographic characteristics, tobacco consumption, diet, physical activity, health care utilization, different health-related behaviors, and self-reported chronic conditions. Results: Overall prevalence of current smoking was 12.2 % and males were more likely to smoke than females (21.5 % vs. 1.1 %). Mean age of smoking initiation was 19.1 years (±6.5 years) with 8.9 % of ever smokers starting before the age of 15 years. Daily shisha smoking was reported by 4.3 % of the population (7.3 % of men and 1.3 % of women). Around 1.4 % of population (2.6 % of men and 0.1 % of women) were daily smokers of cigarette/cigar and shisha. Receiving advice for quitting smoking by health care professionals during the last 12 months was reported by 53.2 % (95 % confidence interval [CI]: 49.8–56.5) of ever smokers. Among ever smokers, 51.3 % of individuals reportedly attempted to quit smoking during the last 12 months. Of those, 25.3 % were successful by the time of the survey. Around 23.3 % of the entire population, 32.3 % of men and 13.5 % of women, were exposed to secondhand smoke for at least one day during the past 7 days at home, work, or school. Conclusions: Although the indicators of tobacco consumption in KSA are better than most of the countries of the Middle East region and high-income countries, there are many potential areas for improvement. Our findings call for the development and implementation of programs to prevent smoking initiation and encourage quitting. To achieve its health goals, KSA may consider increasing taxation on tobacco products as well as other measures.
Background: Performance status (PS) assessment is an integral part of the decision-making process in cancer care. Karnofsky Performance Status (KPS) and Eastern Cooperative Oncology Group (ECOG) PS are the most widely used tools. In some studies, the absolute agreement rate of these tools between observers has been moderate to low. The present study aimed to evaluate the inter-observer reliability and construct validity of the new Functionality Assessment Flowchart (FAF) and compare it with ECOG PS and KPS in a sample of cancer patients. Methods: The patients were recruited by convenience from the waiting rooms of the Breast and Gynecology Ambulatory in a cross-sectional study. Two trained medical students (observer A) and five medical oncologists (observers B) independently rated women according to the ECOG PS, KPS and FAF. After the determining the PS scores, observer A administered the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire to the participants. The agreements between observers A and B were investigated using the absolute agreement rate (%), weighted and unweighted kappa and Spearman’s correlation test. For construct validity, the PS scores were correlated with functional and fatigue scores by performing correlation analysis. Results: Eighty women with a median age of 57 years were included in the study (86 % accrual rate). Among these women, 39 (48.8 %) had advanced cancer. The overall absolute agreement rate between observers was 49.4 % for KPS, 67 % for ECOG PS, and 78.2 % for FAF. When using unweighted kappa values, the inter-observer reliability was “fair”, “moderate” and “substantial” for KPS, ECOG PS and FAF, respectively. However, when using weighted kappa statistics, “substantial” agreement was observed for KPS and ECOG PS and “nearly perfect” agreement was observed for FAF. All of the PS scales correlated very well with the functional and fatigue scores. Conclusions: We present a new instrument with moderate to high inter-observer agreement and adequate construct validity to measure PS in cancer patients.
Background: Over 1.2 billion people lack access to clean water. However, little is known about what children drink when there is no clean water. We investigated the prevalence of receiving no water and what Indian children drink instead. Methods: We analysed children’s beverage consumption using representative data from India’s National Family and Health Survey (NFHS-3, 2005–2006). Consumption was based on mothers’ reports (n = 22,668) for children aged 6–59 months (n = 30,656). Results: About 10 % of Indian children had no water in the last 24 h, corresponding to 12,700,000 children nationally, (95 % CI: 12,260,000 to 13,200,000). Among children who received no water, 23 % received breast or fresh milk and 24 % consumed formula, “other liquid”, juice, or two or more beverages. Children over 2 were more likely to consume non-milk beverages, including tea, coffee, and juice than those under 2 years. Those in the lowest two wealth quintiles were 16 % less likely to have received water (OR = 0.84; 95 % CI: 0.74 to 0.96). Compared to those living in households with bottled, piped, or tanker water, children were significantly less likely to receive water in households using well water (OR = 0.75; 95 % CI: 0.64 to 0.89) or river, spring, or rain water (OR = 0.70; 95 % CI: 0.53 to 0.92) in the last 24 h. Conclusions: About 13 million Indian children aged 6–59 months received no water in the last 24 h. Further research is needed to assess the risks potentially arising from insufficient water, caffeinated beverages, and high sugar drinks at early stages of life.
Background: Gestational diabetes mellitus (GDM) affects approximately 5–15 % of pregnant women in Australia. Highest rates are seen among women who are obese, from specific ethnic backgrounds and low socio-economic circumstance. These features also impact on uptake of self-management recommendations. GDM that is not well managed can give rise to serious pregnancy complications. The aim of this project was to develop and test an intervention to improve knowledge of GDM and GDM self-management principles. Methods: A web-based intervention, consisting of resources aimed at a low level of literacy, was developed and tested among multi-ethnic women at a metropolitan hospital in Melbourne Australia. A basic one-group pre-test/post-test design was used to explore the impact of the intervention on knowledge, in 3 domains: (1) Knowledge of GDM; (2) food values, and;(3) GDM self-management principles. Questionnaire data was analysed using Statistical Package for the Social Sciences (SPSS), version 21.0. Fisher’s exact test was used to test for an improvement in each knowledge scale. Results: Twenty-one women with GDM, from multi-ethnic backgrounds, participated in the testing of the intervention. Results indicated that the intervention was effective at improving knowledge scores and this effect was greatest in the first domain, knowledge of GDM. Although some improvement of knowledge scores occurred in the other two domains, food values and self-management principles, these improvements were less than expected. This finding may relate to a number of misunderstandings in the interpretation of the web resource and survey questions. These issues will need to be resolved prior to proceeding to a clinical trial. Conclusion: Initial results from this study look promising and suggest that with some improvements, the intervention could prove a useful adjunct support for women with GDM from multi-ethnic and low socio-economic backgrounds. Conducting a randomised controlled trial is feasible in the future and will provide a useful means of examining efficacy of the intervention.