Conducting requirements analyses for research using routinely collected health data: a model driven approach.

BACKGROUND: Medical research increasingly requires the linkage of data from different sources. Conducting a requirements analysis for a new application is an established part of software engineering, but rarely reported in the biomedical literature; and no generic approaches have been published as to how to link heterogeneous health data. METHODS: Literature review, followed by a consensus process to define how requirements for research, using, multiple data sources might be modeled. RESULTS: We have developed a requirements analysis: i-ScheDULEs - The first components of the modeling process are indexing and create a rich picture of the research study. Secondly, we developed a series of reference models of progressive complexity: Data flow diagrams (DFD) to define data requirements; unified modeling language (UML) use case diagrams to capture study specific and governance requirements; and finally, business process models, using business process modeling notation (BPMN). DISCUSSION: These requirements and their associated models should become part of research study protocols.

Detection of flubromazolam in patients with suspected non-medical drug use attending emergency departments in the United Kingdom.

INTRODUCTION: Non-medical use of novel benzodiazepines has recently become common. Here, we describe the recent frequent detection of flubromazolam in patients attending United Kingdom emergency departments. METHODS: Adults presenting to participating hospitals with toxicity after suspected drug misuse were studied between March 2015 and January 2021. Clinical features were recorded using consistent methodology and biological samples analysed using liquid chromatography-tandem mass-spectrometry. RESULTS: Flubromazolam and/or its mono-hydroxylated metabolite were detected in samples from 14 of 957 patients, all presenting since July 2020. Reported clinical features included reduced level of consciousness (10), confusion/agitation (6) and acidosis (5) but multiple other substances were detected in all patients. All patients survived to discharge (length of hospital stay 3.0 to 213 h, median 24.1 h). There was no correlation between admission blood/serum flubromazolam concentrations (range 1.7-480.5 ng/ml, median 7.4 ng/ml) and Glasgow Coma Scale or length of hospital stay. In one patient who needed intubation and ventilation for five days, there was an exponential decline in flubromazolam concentrations with time (calculated half-life 39.8 h). Hydroxyl-flubromazolam was also identified at all time points. CONCLUSIONS: Flubromazolam has been detected frequently in drug users presenting to UK emergency departments since July 2020. Prolonged toxicity may occur as a result of the long half-life of flubromazolam and the production of metabolites likely to be active.

The treatment of co-morbidities in older patients with metastatic cancer.

PURPOSE: The purpose of the study was to determine whether older patients with metastatic cancer continue to take medications for the treatment of pre-existing co-morbidities after the diagnosis of metastatic disease. METHODS: Between November 2008 and June 2009, patients over the age of 65 with metastatic cancer were interviewed. Medical records were reviewed in order to ascertain current medication use and relevant past medical history. Classes of medication of interest were prospectively defined; these were anti-hypertensives, lipid-lowering drugs, anti-platelet agents, anti-coagulants and bisphosphonates. RESULTS: One hundred patients were recruited, with a median age of 73.5 years (range 65-88); 52% were women. The primary cancer sites were breast, 36%; prostate, 27%; colon, 14%; other, 23%. The median performance status of the patients was 2. The median number of medications was 7 (range 1-17). Eighty-one percent of patients were found to be taking one or more of the predefined medications for treatment of a long-term co-morbidity. Overall 52% of patients had side effects attributed to these medications. CONCLUSIONS: Patients with metastatic cancer continue to take drugs for prevention of co-morbidities which are associated with side effects and inconvenience. The benefits of these drugs are likely to be minimal, and medication reviews should be undertaken to address their appropriateness.