Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia

Background: Malaria caused by Plasmodium vivax and Plasmodium falciparum is among the major public health problems in most endemic areas of the world. Artemisinin-based combination therapy (ACT) has been recommended as a first-line treatment for uncomplicated Plasmodium falciparum malaria almost in all endemic regions. Since ineffectively regulated medicines in resource limited settings could favour infiltration of poor quality anti-malarial medicines into pharmaceutical supply chain and jeopardize a positive treatment outcome, regular monitoring of the quality of anti-malarial medicines is critical. Thus, the aim of this study was to assess the quality of fixed dose combination (FDC) artemether (ART)/lumefantrine (LUM) tablets available in Jimma zone, Ethiopia. Methods: This study was conducted in Jimma zone, Ethiopia. A total of 74 samples of FDC ART/LUM (20mg ART/120mg LUM) tablets were collected from 27 public facilities. All samples were subjected to visual inspection and the relevant information was recorded. The samples were transported to Jimma University Laboratory of Drug Quality (JuLaDQ) and stored at ambient temperature (20 degrees C to 25 degrees C) until analysis. The Pharmacopoeial conform/non-conform methods and the risk-based Derringer's desirability function approach were employed to assess the pharmaceutical quality of the investigated products. Results: The visual inspection results revealed that there were no signs of falsified in the investigated products. Identification test results of samples indicated that all samples contained the stated active pharmaceutical ingredients (APIs). The results of uniformity of mass indicated that all samples complied with International Pharmacopoeial specification limits. The assay results, expressed as percent label claim (%lc) of ART (89.8 to 108.8%, meanSD=99.1 +/- 3.9%) and LUM (90.0 to 111.9%, mean +/- SD=98.2 +/- 3.8%) revealed that, all samples complied with International Pharmacopoeia acceptance specification limits (i.e. 90-110%lc), except one generic product (IPCA Laboratories Ltd., India) which contains excessive LUM (111.9 +/- 1.7%lc). The risk priority number (RPN) results revealed that assay (RPN=392) is relatively the most critical quality attribute followed by identity (RPN=280) and mass uniformity (40). Quality evaluation based on psycho-physical Harrington's scale revealed that more than 96% of samples were within the acceptable ranges (D >= 0.7-1.0). Conclusions: Both Pharmacopoeial and risk-based desirability function approaches to quality evaluation applied to the investigated products revealed that above 96% FDC ART/LUM tablets circulating in public settings of Jimma zone are of good quality

Causes of Mode Effects: Separating out Interviewer and Stimulus Effects in Comparisons of Face-to-Face and Telephone Surveys

We identify the causes of mode effects in comparisons of face-to-face and telephone surveys, by testing for differences in the extent of satisficing and social desirability bias due to differences in the stimulus (visual vs. aural presentation of response options) and the presence vs. absence of the interviewer. The stimulus did not lead to differential measurement error; the presence or absence of the interviewer however did. Telephone respondents were far more likely to give socially desirable responses than face-to-face respondents when the stimulus was the same for both modes

An in silico approach for modelling T-helper polarizing iNKT cell agonists

Many analogues of the glycolipid alpha-galactosylceramide (α-GalCer) are known to activate iNKT cells through their interaction with CD1d-expressing antigen-presenting cells, inducing the release of Th1 and Th2 cytokines. Because of iNKT cell involvement and associated Th1/Th2 cytokine changes in a broad spectrum of human diseases, the design of iNKT cell ligands with selective Th1 and Th2 properties has been the subject of extensive research. This search for novel iNKT cell ligands requires refined structural insights. Here we will visualize the chemical space of 333 currently known iNKT cell activators, including several newly tested analogues, by more than 3000 chemical descriptors which were calculated for each individual analogue. To evaluate the immunological responses we analyzed five different cytokines in five different test-systems. We linked the chemical space to the immunological space using a system biology computational approach resulting in highly sensitive and specific predictive models. Moreover, these models correspond with the current insights of iNKT cell activation by α-GalCer analogues, explaining the Th1 and Th2 biased responses, downstream of iNKT cell activation. We anticipate that such models will be of great value for the future design of iNKT cell agonists

The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) : development and UK validation

Background There is increasing international interest in the concept of mental well-being and its contribution to all aspects of human life. Demand for instruments to monitor mental well-being at a population level and evaluate mental health promotion initiatives is growing. This article describes the development and validation of a new scale, comprised only of positively worded items relating to different aspects of positive mental health: the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Methods WEMWBS was developed by an expert panel drawing on current academic literature, qualitative research with focus groups, and psychometric testing of an existing scale. It was validated on a student and representative population sample. Content validity was assessed by reviewing the frequency of complete responses and the distribution of responses to each item. Confirmatory factor analysis was used to test the hypothesis that the scale measured a single construct. Internal consistency was assessed using Cronbach's alpha. Criterion validity was explored in terms of correlations between WEMWBS and other scales and by testing whether the scale discriminated between population groups in line with pre-specified hypotheses. Test-retest reliability was assessed at one week using intra-class correlation coefficients. Susceptibility to bias was measured using the Balanced Inventory of Desired Responding. Results WEMWBS showed good content validity. Confirmatory factor analysis supported the single factor hypothesis. A Cronbach's alpha score of 0.89 (student sample) and 0.91 (population sample) suggests some item redundancy in the scale. WEMWBS showed high correlations with other mental health and well-being scales and lower correlations with scales measuring overall health. Its distribution was near normal and the scale did not show ceiling effects in a population sample. It discriminated between population groups in a way that is largely consistent with the results of other population surveys. Test-retest reliability at one week was high (0.83). Social desirability bias was lower or similar to that of other comparable scales. Conclusion WEMWBS is a measure of mental well-being focusing entirely on positive aspects of mental health. As a short and psychometrically robust scale, with no ceiling effects in a population sample, it offers promise as a tool for monitoring mental well-being at a population level. Whilst WEMWBS should appeal to those evaluating mental health promotion initiatives, it is important that the scale's sensitivity to change is established before it is recommended in this context

Bias and Equivalence in Cross-Cultural Research

Bias and equivalence are key concepts in the methodology of cross-cultural studies. Bias is a generic term for any challenge of the comparability of cross-cultural data; bias leads to invalid conclusions. The demonstration of equivalence (lack of bias) is a prerequisite for any cross-cultural comparison. we first describe considerations that are relevant when choosing instruments in a cross-cultural study, notably the question of whether an existing or new instrument is to be preferred.We then describe the definition, manifestation, and sources of three types of bias (construct, method, and item bias), and three levels of equivalence (construct, measurement unit, and full score equivalence). We provide strategies to minimize bias and achieve equivalence that apply either to the design, implementation, or statistical analysis phase of a study. The need to integrate these strategies in cross-cultural studies is emphasized so as to increase the validity of conclusions regarding cross-cultural similarities and differences and rule out alternative explanations of cross-cultural differences

Evaluating 'Prefer not to say' Around Sensitive Disclosures

As people's offline and online lives become increasingly entwined, the sensitivity of personal information disclosed online is increasing. Disclosures often occur through structured disclosure fields (e.g., drop-down lists). Prior research suggests these fields may limit privacy, with non-disclosing users being presumed to be hiding undesirable information. We investigated this around HIV status disclosure in online dating apps used by men who have sex with men. Our online study asked participants (N=183) to rate profiles where HIV status was either disclosed or undisclosed. We tested three designs for displaying undisclosed fields. Visibility of undisclosed fields had a significant effect on the way profiles were rated, and other profile information (e.g., ethnicity) could affect inferences that develop around undisclosed information. Our research highlights complexities around designing for non-disclosure and questions the voluntary nature of these fields. Further work is outlined to ensure disclosure control is appropriately implemented around online sensitive information disclosures

A COMPARISON OF HYPOTHETICAL PHONE AND MAIL CONTINGENT VALUATION RESPONSES FOR GREEN PRICING ELECTRICITY PROGRAMS

To date, much of the policy and research debate on contingent valuation mode effects has relied on experiences drawn from other research disciplines. This study provides the first contingent valuation phone-mail comparison that meets current standards for response rates, draws from a general population, is relevant to the valuation of general environmental goods, and allows comparisons with actual sign-ups. Consistent with previous research in other disciplines, social desirability bias is found in responses to subjective questions --thus leading to more environmentally favorable responses on the phone. However, this effect does not carry over to hypothetical participation decisions. Hypothetical bias is found in both modes. Yet, application of calibration methods using debriefing questions provided nearly identical values across modes. As such, neither mode appears to dominate from the perspective of providing more valid estimates of actual participation decisions. The selection of survey mode must be based on other criteria.Environmental Economics and Policy,

Quality of medicines commonly used in the treatment of soil transmitted helminths and Giardia in Ethiopia: a nationwide survey

Background: The presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia. Methods/Principal Findings: A multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality. Conclusions/Significance: This study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia

Anthropometrics without numbers!

(Anthropometrics without Numbers! An Investigation of Designers' Use and Preference of People Data By Nickpour F and Dong H) There is still missing knowledge to encourage and support designers in adoption and implementation of inclusive design. Some of this missing knowledge comes in the form of anthropometric data which provides accessible information on users' capabilities and limitations. Support and resources for designers on this type of data seems to be limited and exclusive. This study focuses on evaluating the existing use of anthropometric data by professional designers, aiming to explore means of presenting such data more effectively. Ten UK-based design consultancies were interviewed and completed questionnaires collecting information on designer’s current use of anthropometric data, their suggestions on presentation of that data and their preferences on data tools. It is concluded that the use of anthropometric data sources by designers is very limited and minimal; experienced designers tend to rely mainly on experimental methods such as physical prototyping and engagement with people. The results provide insights into designers' existing approaches to data collection and use. This study highlights the need for development of a highly visual, simple and intuitive data tool based on the interviewed designers’ preferences and suggestions. This has to be done by carefully adopting the designers’ existing approaches to data collection and use and by adapting existing data into that