STUDY QUESTION: Whether FDA death data in the PLATO trial matched the local site records.
STUDY DESIGN: The NDA spreadsheet contains 938 precisely detailed PLATO deaths. We obtained and validated local evidence for 52 deaths among 861 PLATO patients from 14 enrolling sites in 8 countries and matched those with the official NDA dataset submitted to the FDA.
MEASURES AND OUTCOMES: Existence, precise time, and primary cause of deaths in PLATO.
RESULTS: Discrepant to the NDA document, sites confirmed 2 extra unreported deaths (Poland and Korea) and failed to confirm 4 deaths (Malaysia). Of the remaining 46 deaths, dates were reported correctly for 42 patients, earlier (2 clopidogrel), or later (2 ticagrelor) than the actual occurrence of death. In 12 clopidogrel patients, cause of death was changed to "vascular," whereas 6 NDA ticagrelor "nonvascular" or "unknown" deaths were site-reported as of "vascular" origin. Sudden death was incorrectly reported in 4 clopidogrel patients, but omitted in 4 ticagrelor patients directly affecting the primary efficacy PLATO endpoint.
CONCLUSIONS: Many deaths were inaccurately reported in PLATO favoring ticagrelor. The full extent of mortality misreporting is currently unclear, while especially worrisome is a mismatch in identifying primary death cause. Because all PLATO events are kept in the cloud electronic Medidata Rave capture system, securing the database content, examining the dataset changes or/and repeated entries, identifying potential interference origin, and assessing full magnitude of the problem are warranted.
METHODS: Over 30,000 pages of documents have been accessed through the National Archives of Australia in Canberra. These have been photographed, scanned and converted to OCR. The most relevant folders have then been analysed through NVivo 12 to look for relevant mentions of the research question: capital punishment and Malaysia. All probative data is then presented in the article.
RESULTS: The data from National Archives suggests that the UN, Australia, and other western countries were happy to continue supporting Malaysia's drug policy and to elect it to high positions at UN meetings despite their public proclamations that they were opposed to the death penalty.
CONCLUSION: Applying a critical juncture approach, the article concludes that the 1980s was a critical juncture in the movement to abolish the death penalty but abolitionist countries allowed capital punishment to continue for drug offences. This may have set back the abolition movement by decades.
OBJECTIVE: To examine Muslims' (1) perceptions of fasting exemptions, (2) medication usage behaviour, (3) perceptions of relationships with healthcare providers and (4) factors impacting health management during Ramadan.
METHOD: This was a qualitative study employing four focus groups (two groups of women and two groups of men). Adult Muslims (aged 18 years or more) with chronic diseases were invited to participate. Participants were asked open-ended questions about their fasting ability, medication usage behaviours, healthcare access and collaboration with providers during Ramadan. Trained researchers conducted the focus groups interviews in both English and Arabic. Each focus group was recorded, and three investigators independently transcribed the data and extracted themes and categories. Coding terminology issues were resolved through discussion.
RESULTS: Twenty-five Muslims with chronic diseases (e.g., diabetes, hypertension, renal failure and anaemia) participated. The most prominent themes/subthemes were as follows: (1) fasting exemption (e.g., uncontrolled medical conditions), (2) fasting nonexemption (e.g., controlled medical conditions), (3) nonoral medication use during Ramadan, (4) healthcare provider involvement during Ramadan, and (5) factors impacting health management during Ramadan.
CONCLUSION: Muslim patients perceive fasting as an important religious practice, so they tend to self-modify their medication-taking behaviours. Educating pharmacists and other healthcare providers about Muslim culture, especially their strong desire to fast, may lead to Muslims better managing their medications and viewing pharmacists and other healthcare providers as knowledgeable healthcare providers.