Any port in a storm: fieldwork difficulties in dangerous and crisis-ridden settings

This article draws on the experience of conducting fieldwork in Russia, as part of an international comparative examination of health and safety regulatory enforcement in the shipping industry. We discuss the difficulties faced by fieldworkers in ensuring personal safety and maintaining rapport with research respondents in conditions characterized by danger and crisis; a situation made worse by the murder of one of our key gatekeepers. We develop a provisional conceptual framework which draws distinctions between the `frontier'-like nature of settings associated with some research areas, the challenges posed by researching institutions faced by various kinds of crisis, and the sensitivity of the specific research topic in question. We argue that a combination of these dimensions produce particular social spaces, which we term `risksaturated', which are especially corrosive of relations with re

Any port in a storm: fieldwork difficulties in dangerous and crisis-ridden settings

This article draws on the experience of conducting fieldwork in Russia, as part of an international comparative examination of health and safety regulatory enforcement in the shipping industry. We discuss the difficulties faced by fieldworkers in ensuring personal safety and maintaining rapport with research respondents in conditions characterized by danger and crisis; a situation made worse by the murder of one of our key gatekeepers. We develop a provisional conceptual framework which draws distinctions between the `frontier'-like nature of settings associated with some research areas, the challenges posed by researching institutions faced by various kinds of crisis, and the sensitivity of the specific research topic in question. We argue that a combination of these dimensions produce particular social spaces, which we term `risksaturated', which are especially corrosive of relations with re

Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. RESULTS: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. CONCLUSION: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk