Compliance of smokeless tobacco supply chain actors and products with tobacco control laws in Bangladesh, India and Pakistan: protocol for a multicentre sequential mixed-methods study

Introduction: South Asia is home to more than 300 million smokeless tobacco (ST) users. Bangladesh, India and Pakistan as signatories to the Framework Convention for Tobacco Control (FCTC) have developed policies aimed at curbing the use of tobacco. The objective of this study is to assess the compliance of ST point-of-sale (POS) vendors and the supply chain with the articles of the FCTC and specifically with national tobacco control laws. We also aim to assess disparities in compliance with tobacco control laws between ST and smoked tobacco products. Methods and analysis: The study will be carried out at two sites each in Bangladesh, India and Pakistan. We will conduct a sequential mixed-methods study with five components: (1) mapping of ST POS, (2) analyses of ST samples packaging, (3) observation, (4) survey interviews of POS and (5) in-depth interviews with wholesale dealers/suppliers/manufacturers of ST. We aim to conduct at least 300 POS survey interviews and observations, and 6-10 in-depth interviews in each of the three countries. Data collection will be done by trained data collectors. The main statistical analysis will report the frequencies and proportions of shops that comply with the FCTC and local tobacco control policies, and provide a 95% CI of these estimates. The qualitative in-depth interview data will be analysed using the framework approach. The findings will be connected, each component informing the focus and/or design of the next component. Ethics and dissemination: Ethical approvals for the study have been received from the Health Sciences Research Governance Committee at the University of York, UK. In-country approvals were taken from the National Bioethics Committee in Pakistan, the Bangladesh Medical Research Council and the Indian Medical Research Council. Our results will be disseminated via scientific conferences, peer-reviewed research publications and press releases

Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

<p>Abstract</p> <p>Background</p> <p>Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. Given significant heterogeneity among these components, a composite outcome may be judged as being invalid or un-interpretable for estimation of the treatment effect. This paper compares the power of different tests to detect heterogeneity of treatment effect across components of a composite binary outcome.</p> <p>Methods</p> <p>Simulations were done comparing four different models commonly used to analyze correlated binary data. These models included: logistic regression for ignoring correlation, logistic regression weighted by the intra cluster correlation coefficient, population average logistic regression using generalized estimating equations (GEE), and random effects logistic regression.</p> <p>Results</p> <p>We found that the population average model based on generalized estimating equations (GEE) had the greatest power across most scenarios. Adequate power to detect possible composite heterogeneity or variation between treatment effects of individual components of a composite outcome was seen when the power for detecting the main study treatment effect for the composite outcome was also reasonably high.</p> <p>Conclusions</p> <p>It is recommended that authors report tests of composite heterogeneity for composite outcomes and that this accompany the publication of the statistically significant results of the main effect on the composite along with individual components of composite outcomes.</p

Integrating depression care within NCD provision in Bangladesh and Pakistan : a qualitative study

Background Co-morbidity of depression with other non-communicable diseases (NCDs) worsens clinical outcomes for both conditions. Low- and middle-income countries need to strengthen mechanisms for detection and management of co-morbid depression within NCDs. The Behavioural Activation for Comorbid Depression in Non-communicable Disease (BEACON) study explored the acceptability and feasibility of integrating a brief depression intervention (behavioural activation, BA) into NCD services in healthcare facilities in Bangladesh and Pakistan. Methods Face-to-face qualitative interviews were conducted with 43 patients and 18 health workers attending or working in NCD centres in four healthcare facilities in Bangladesh and Pakistan, and with three policy makers in each country. The interviews addressed four research questions (1) how NCD care is delivered, (2) how NCD patients experience distress, (3) how depression care is integrated within NCD provision, and (4) the challenges and opportunities for integrating a brief depression intervention into usual NCD care. The data were analysed using framework analysis, organised by capability, opportunity and motivation factors, cross-synthesised across countries and participant groups. Results Patients and health workers described NCD centres as crowded and time pressured, with waiting times as long as five hours, and consultation times as short as five minutes; resulting in some patient frustration. They did not perceive direct links between their distress and their NCD conditions, instead describing worries about family and finance including affordability of NCD services. Health worker and policy maker accounts suggested these NCD centres lacked preparedness for treating depression in the absence of specific guidelines, standard screening tools, recording systems or training. Barriers and drivers to integrating a brief depression intervention reflected capability, opportunity and motivation factors for all participant groups. While generally valuing the purpose, significant challenges included the busy hospital environment, skill deficits and different conceptions of depression. Conclusions Given current resource constraints and priorities, integrating a brief psychological intervention at these NCD centres appears premature. An opportune first step calls for responding to patients’ expressed concerns on service gaps in provisioning steady and affordable NCD care. Acknowledging differences of conceptions of depression and strengthening psychologically informed NCD care will in turn be required before the introduction of a specific psychological intervention such as BA

A study about the frequency of taste disorders.

Although 5% of the general population exhibit a functional anosmia, little is known about the frequency of gustatory disorders. Whenever taste function has been tested within large sociodemographic studies, so far only short test versions were applied making the interpretation difficult. Using two psychophysical taste tests, the validated "taste strips" and suprathreshold taste solutions of the four basic tastes sweet, sour, salty and bitter we investigated 761 healthy subjects within the age range of 5-89 years. Prior to testing, all subjects rated their taste function. According to testing with the taste strips, 5.3% scored below the result considered as hypogeusia. All four taste sprays were correctly identified by 82.3% of all subjects. Results of the two taste tests correlated positively (r = 0.33, p > 0.001), and there was a significant negative correlation between age and test results. However, we never observed complete ageusia. Misinterpretations of tastes were surprisingly common. In summary, hypogeusia was present in 5% while complete ageusia seems to be very rare, in contrast to misinterpretations of tastes