Traditionally, informed consent for clinical research involves the patient reading an approved Participant Information Sheet, considering the information presented and having as much time as they need to discuss the study information with their friends and relatives, their clinical care and the research teams. This system works well in the ‘planned’ or ‘elective’ setting. But what happens if the patient requires urgent treatment for an injury or emergency?
This article reviews the legal framework which governs informed consent in the emergency setting, discusses how the approach taken may vary according to the details of the emergency and the treatment required, and reports on the patients’ view of providing consent following a serious injury. We then provide some practical tips for managing the process of informed consent in the context of injuries and emergencies.
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Health economic evaluations potentially provide valuable information to clinicians, health care administrators, and policy makers regarding the financial implications of decisions about the care of patients. The highest quality research should be used to inform decisions that have direct impact on the access to care and the outcome of treatment. However, economic analyses are often complex and use research methods which are relatively unfamiliar to clinicians. Furthermore, health economic data have substantial national, regional, and institutional variability, which can limit the external validity of the results of a study. Therefore, minimum guidelines that aim to standardise the quality and transparency of reporting health economic research have been developed, and instruments are available to assist in the assessment of its quality and the interpretation of results.
The purpose of this editorial is to discuss the principal types
of health economic studies, to review the most common instruments
for judging the quality of these studies and to describe current
reporting guidelines. Recommendations for the submission of these
types of studies to
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The importance for observing the intention-to-treat approach in clinical studies is explained.
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The extent and depth of routine health care data are growing at an ever-increasing rate, forming huge repositories of information. These repositories can answer a vast array of questions. However, an understanding of the purpose of the dataset used and the quality of the data collected are paramount to determine the reliability of the result obtained.
This Editorial describes the importance of adherence to sound
methodological principles in the reporting and publication of research
using ‘big’ data, with a suggested reporting framework for future
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We explore the limitations of complete reliance on evidence-based medicine which can be diminished by confounding issues and sampling bias. Other strategies which may be reasonably invoked are discussed.
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This editorial examines the influence of the National Institute for Clinical Excellence (NICE) on the conduct of orthopaedic surgery. It proffers criticism and suggests ways of improvement.