How representative are insomnia clinical trials?

OBJECTIVES: To address the question of how representative subjects studied in hypnotic clinical trials are of the broader insomnia population, this study assessed initial contact rates and reasons for inclusion and exclusion during recruitment to an efficacy trial and to a safety trial of Food & Drug Administration (FDA) approved hypnotics. METHODS: Otherwise heathy persons meeting Diagnostic Statistical Manual, Fourth Edition, Revised (DSM-IVR) criteria for insomnia were recruited. In one study, persons 32-65 yrs, were invited to a 12 month trial of nightly use of zolpidem or placebo. In the other, persons 21-64 yrs with driver's licenses were recruited to test the effects of a hypnotic on live on-the-road driving ability. In both studies screening was conducted through an initial telephone interview followed by a clinic visit. RESULTS: In the United States (US) study 13% (n = 410) of 3180 initial contacts and in the Netherlands (NL) study 67% (n = 53) of the 79 initial contacts proceeded to the clinic visit. Of those at clinic 25% of US and 37% of NL participants failed to meet additional insomnia criteria. Mental health exclusions accounted for 24% of US and 23% of NL participants and medical problems accounted for 23% of US and 9% NL exclusions. Finally 20% of US and 26% of NL participants were excluded for drug use/abuse histories. After all screening 4% of the initial US contacts and 0% of the NL contacts entered the study. CONCLUSIONS: These data suggest persons entering insomnia hypnotic clinical trials are a highly selected sample that is unlikely to be representative of the broad insomnia population or the population of potential medication users.

Cancer risk factors and screening in the off-reserve First Nations, Métis and non-Aboriginal populations of Ontario.

INTRODUCTION: This study describes the prevalence of smoking, obesity, sedentary behaviour/physical activity, fruit and vegetable consumption and alcohol use as well as the uptake of breast, cervical and colorectal cancer screening among First Nations and Métis adults in Ontario and compares these to that of the non-Aboriginal population. METHODS: We used the Canadian Community Health Survey (2007 to 2011 combined) to calculate prevalence estimates for the 3 ethnocultural populations. RESULTS: First Nations and Métis adults were significantly more likely than non-Aboriginal adults to self-report smoking and/or to be classified as obese. Alcohol use exceeding cancer prevention recommendations and inadequate fruit and vegetable consumption were more common in First Nations people than in the non-Aboriginal population. First Nations women were more likely to report having had a Fecal Occult Blood Test in the previous 2 years than non-Aboriginal women. No significant differences across the 3 ethnocultural groups were found for breast and cervical screening among women or colorectal screening among men. CONCLUSION: Without intervention, we are likely to continue to see a significant burden of smoking- and obesity-related cancers in Ontario's Aboriginal population.

TITRE: Facteurs de risque et dépistage du cancer chez les membres des Premières Nations vivant hors réserve, chez les Métis et chez les non-Autochtones en Ontario. INTRODUCTION: Cette étude vise à décrire la prévalence du tabagisme, de l'obésité, des comportements sédentaires et de l'activité physique, de la consommation de fruits et de légumes et de la consommation d'alcool ainsi que la participation au dépistage du cancer du sein, du cancer du col de l'utérus et du cancer colorectal chez les adultes des Premières Nations et métis en Ontario, par rapport à la population non autochtone. MÉTHODOLOGIE: Nous avons utilisé les données de l'Enquête sur la santé dans les collectivités canadiennes (données de 2007 à 2011 combinées) pour calculer les estimations de la prévalence chez les trois populations ethnoculturelles. RÉSULTATS: Par rapport aux adultes non autochtones, les adultes des Premières Nations et métis étaient beaucoup plus nombreux à déclarer fumer et à être classés comme obèses. Les membres des Premières Nations étaient plus nombreux que la population non autochtone à consommer de l'alcool au-delà des recommandations en matière de prévention du cancer et à consommer insuffisamment des fruits et des légumes. Les femmes des Premières Nations étaient plus nombreuses que les femmes non autochtones à déclarer avoir fait l'objet d'un dépistage par recherche de sang occulte dans les selles au cours des deux dernières années. Aucune différence significative n'a été observée entre les membres des trois groupes ethnoculturels en ce qui concerne le dépistage du cancer du sein et du cancer du col de l'utérus chez les femmes et le dépistage du cancer colorectal chez les hommes. CONCLUSION: Si l'on intervient pas, il est probable que les cancers liés au tabagisme et à l'obésité continueront à représenter un fardeau considérable au sein de la population autochtone de l'Ontario.

The economic burden of obesity worldwide: a systematic review of the direct costs of obesity.

In the last decade, the prevalence of obesity has increased significantly in populations worldwide. A less dramatic, but equally important increase has been seen in our knowledge of its effects on health and the burden it places on healthcare systems. This systematic review aims to assess the current published literature on the direct costs associated with obesity. A computerized search of English language articles published between 1990 and June 2009 yielded 32 articles suitable for review. Based on these articles, obesity was estimated to account for between 0.7% and 2.8% of a country's total healthcare expenditures. Furthermore, obese individuals were found to have medical costs that were approximately 30% greater than their normal weight peers. Although variations in inclusion/exclusion criteria, reporting methods and included costs varied widely between the studies, a lack of examination of how and why the excess costs were being accrued appeared to be a commonality between most studies. Accordingly, future studies must better explore how costs accrue among obese populations, in order to best facilitate health and social policy interventions.