ABSTRACT
The use of routinely collected electronic healthcare records (EHR) for outcome assessment in clinical trials has been described as a 'disruptive' new technique more than a decade ago. Despite this potential, significant methodological issues and regulatory barriers have hampered the progress in this area. This article discusses the key considerations that trialists should take into account when incorporating EHR into their trials. These include considerations of the clinical relevance of the outcome, data timeliness and quality, ethical and regulatory issues, and some practical considerations for clinical trials units. In addition, this article describes the benefits of using EHR which include cost, reduced trial burden for participants and staff, follow up efficiencies, and improved health economic evaluation procedures. We also describe the major regulatory and start up costs of using EHR in clinical trials. This article focuses on the UK specific EHR landscape in clinical trials and would help researchers and trials units considering the use of this method of outcome data collection in their next trial. If the issues described are mitigated, this method will be a formidable tool for conducting pragmatic clinical trials.
Subject(s)
Clinical Trials as Topic , Electronic Health Records , Outcome Assessment, Health Care , United Kingdom , Humans , Clinical Trials as Topic/standards , Clinical Trials as Topic/methods , Outcome Assessment, Health Care/methods , Routinely Collected Health DataABSTRACT
Amiodarone is an antiarrhythmic drug used to treat cardiac tachyarrhythmias. It has many adverse effects, with thyroid dysfunction one of the most notable. Through various mechanisms, both thyrotoxicosis and hypothyroidism can occur secondary to amiodarone therapy. There are two types of amiodarone-induced thyrotoxicosis: type 1 occurs in those with pre-existing thyroid disease and is treated with thionamide, whereas type 2 occurs in those without and is treated with glucocorticoids. Patients with amiodarone-induced hypothyroidism may be given levothyroxine to replace thyroid hormone, but in some cases, the appropriate management may be cessation of amiodarone.
Subject(s)
Amiodarone , Hypothyroidism , Thyrotoxicosis , Humans , Amiodarone/adverse effects , Anti-Arrhythmia Agents/adverse effects , Hypothyroidism/chemically induced , Hypothyroidism/drug therapy , Thyrotoxicosis/chemically induced , Thyrotoxicosis/drug therapyABSTRACT
The prevalence of type 2 diabetes mellitus is expected to rise in the frail elderly population, which will have significant consequences for the health economy. Symptoms of hypoglycaemia can be subtle in the elderly. Hypoglycaemia accounts for more hospital admissions than hyperglycaemia. Treatment targets are set based on the risk of adverse events resulting from treatment and the benefits expected from tighter glycaemic control. The different medications available are discussed including the different types of insulin, in particular relation to usage in older adults. The choice of therapy is based on the targets, comorbidities and the characteristics of each antidiabetic agent. Deintensification of therapy should be considered in patients who experience adverse effects. Treatment guidelines should be formulated based on the above principles, as many current guidelines do not incorporate deintensification of therapy.
