Informed consent: what is it? Who can give it? How do we improve it?

The freedom to choose is integral to our daily lives, directs our interactions with patients, and is a key component of our conduct of human-subjects research. Most of the historical errors and atrocities in human experimentation had at their core a failure of consent. In response to those events, national and international law developed to direct researchers to a process of informed consent to participate in research. The application of this process, though, can be challenging. What does this process look like? Does it require written documentation, and if so what type? Who can give informed consent? Though researchers worldwide would agree on the concept of informed consent, the nuts and bolts of applying this ideal can create obstacles to researchers, confusion to subjects, and increasing regulations that may or may not help achieve the goal. I will review the current regulatory guidelines, summarize the types of consent, and consider options for improving the informed-consent process.     

Social justice advocacy in nursing: what is it? How do we get there?

Social justice advocacy is an expectation of all nurses as expressed in the professional codes that guide nursing practice. Nursing literature reflects this shift in the focus of nursing advocacy, providing insight into the potentials and challenges associated with nursing's evolution toward a broader social justice advocacy model. This article describes the concept of social justice advocacy as currently reflected in professional codes and nursing literature and contrasts this with the individual patient-nurse advocacy model, which continues to dominate in nursing practice today. Challenges associated with movement toward a social justice advocacy model and options for addressing these hurdles are also discussed.     

The Groningen Protocol: what is it, how do the Dutch use it, and do we use it here?

In this article, a sensitive, complex and provocative issue is discussed. It will undoubtedly stimulate a variety of opinions. What do you think? Post your comments about this topic on the Pediatric Nursing Web site and read what others have to say as well. Visit our homepage at www.pediatricnursing.net and click on "Discussions." The opinions and assertions contained herein are the private views of the contributors and do not necessarily reflect the views of Pediatric Nursing or the publisher.     

The history and evolution of hospital payment systems: how did we get here?

After many years of testing and experimentation, most insurance companies, managed care plans, and self-insured employers now have effective programs in place to manage their health care expenditures. More important, the recent efforts to balance the federal budget have led to a series of changes in the payment systems for both Medicare and Medicaid that are designed to reduce the amount of money the federal government will spend on health care services in the future. It appears that all the loopholes have been closed. Many hospitals, as well as other types of providers, are now projecting flat revenue growth, while some are actually anticipating declines in revenues. To fully understand health care finance and be effective in reducing costs, hospital managers need to understand the history and evolution of the payment system and how they have influenced both cost measurement and cost control efforts.     

What do we know about perioperative hypersensitivity reactions and what can we do to improve perioperative safety?

Hypersensitivity reactions are an important aspect of perioperative care and are a crucial interdisciplinary issue in anaesthesiological practice, as well as allergological and laboratory diagnostics. This phenomenon was observed as early as the 1980s and 1990s in Western European countries, and knowledge on this subject has grown significantly over time. Although hypersensitivity reactions are not frequent events (the incidence of perioperative hypersensitivity reactions ranges from 1:386 to 1:13 000 procedures, with higher frequency − 1 per 6500 general anaesthesias with neuromuscular blocking agents administrations), their courses are unfortunately serious and life-threatening. It should also be noted that there is no information regarding the occurrence of perioperative hypersensitivity reactions in many countries. Hence, global assessment of the problem is underestimated. The primary source of actual knowledge comes from epidemiological studies, which indicate an increasing frequency of hypersensitivity reaction occurrence and changes in aetiological factors. The first report from France (1984 to 1989) described two main causes – neuromuscular blocking agents and hypnotic agents. The following years confirmed an increase in perioperative hypersensitivity reactions associated with latex and antibiotics. The most recent data from the National Audit Project 6 indicated increased participation of antibiotics, chlorhexidine, and contrast agents. The results of epidemiological analyses are the basis of medical management guidelines and practice modification. Thanks to the activity of many organisations monitoring the intensity and nature of perioperative hypersensitivity reactions, guidelines for diagnostics and management have been developed. This article presents the results of numerous studies, including the first and the most recent, from various geographical regions. The clinical significance, pathogenesis mechanisms are also discussed. This publication also presents important directions for further scientific and epidemiological research on perioperative hypersensitivity reactions.

Key messages

• The incidence of perioperative hypersensitivity reactions ranges from 1:386 to 1:13 000 procedures, with higher frequency – 1 per 6500 general anaesthesias with neuromuscular blocking agents administrations.
• Reactions may occur during the first episode of anaesthesia, most frequently in the induction of general anaesthesia, and much less frequently during postoperative follow-up.
• The first reports of perioperative hypersensitivity reaction come from the 1990s, and knowledge on this subject has grown significantly over time.
• In many countries, multidisciplinary teams and organisations have been established to identify, monitor the occurrence of this phenomenon, and have set the directions of medical activities and have changed the rules and recommendations.
• There is no information about the occurrence of perioperative hypersensitivity reactions in many countries, and global assessment of the problem is underestimated. Additionally, there is a great need to develop a system to monitor their occurrence in other countries.
• The long-term epidemiologic studies have demonstrated variability in pharmacologic triggers. However, the main pharmacological substances (antibiotics, muscle relaxants, disinfectans, contrast agents) are related to aspects of patient safety during anaesthesia.

     

Teamwork in primary care: How much do we know about it?

This is the first of a series of occasional articles in which doctors, nurses and other therapists will be ‘coming clean’ about their own lifestyles. To launch the series, Sir Douglas Black, former President of the Royal College of Physicians, writes about the responsibility of doctors to set an example to others, but explains how in reality they are often thwarted by the pressures of their work. Sir Douglas goes on to write about his own lifestyle which, he admits, does not conform to any particular model     

Telling people about screening programmes and screening test results: how can we do it better?

To make an informed choice about whether to be screened, people need information that allows them to weigh up the benefits and harms of screening. To understand their screening test results they require even more information. Yet currently, people attending a screening programme or considering a screening test may only be told that the test can detect disease or risk factors for disease, and that early intervention improves outcomes. When given their test results, people are generally only told the test was abnormal ("positive") or normal ("negative"). We believe that information given before and after the screening test can, and should, be improved. This will probably require information that includes both the benefits and harms of screening and is probabilistic. Indeed, we believe the traditional dichotomisation of screening test results into positive and negative is problematic, and could be replaced by standard use of risks or probabilistic data before and after screening. The relevant risk data could be explained in a range of ways, for example, quantitatively, qualitatively, and/or by "anchoring" to everyday experiences. In this paper we explore why dichotomisation of screening test results is problematic and look at the adverse consequences of presenting test results in terms of true and false, positive and negative. We present some ideas on alternative ways of providing information on screening programmes and screening test results. Our aim is to stimulate debate about these issues and to provide some starting points which could be further developed and evaluated in a wide range of screening programmes.     

Long-term blood pressure control: what can we do?

There are unique problems associated with the long-term control of blood pressure (BP) in patients with hypertension. Many of these problems warrant specific discussion for the primary care physician. Up to one-third of high-risk patients are estimated to have uncontrolled hypertension. Although long-term control is essential to avoid complications of cardiovascular disease, such as myocardial infarction, stroke, heart failure, and kidney disease, it can become troublesome because of challenges with patient compliance and adherence to medication regimens. This may be due to low tolerability profiles, complicated regimens, or prohibitive costs. Trials have shown that a combination approach may reduce side effects with complementary therapies such as a calcium channel blocker (CCB)/angiotensin receptor blocker (ARB) combination. Combination therapy can be used in any patient group not responsive to monotherapy, or who remain 20 mm Hg higher than their BP goal. This method may achieve the goal of reaching target BP sooner as a first-line approach and, in a fixed-dose combination, may be a more economic choice as well as a simpler regimen for the patient. Together with supportive measures, CCB/ARB combinations are a compelling alternative for the long-term treatment of hypertension.     

Hepatitis C virus infection in children: How do we prevent it and how do we treat it?

Introduction: Hepatitis C virus (HCV) infection is an important contributor to the worldwide burden of liver-related morbidity and mortality. Mother-to-child transmission of HCV ranges from 6 to 11% in different populations globally, but accurate estimates on the burden of pediatric HCV infection are limited because screening approaches are not consistent.

Areas covered: The advent of new direct-acting antiviral agents that achieve very high rates of sustained virologic response (representing virologic cure) with short (i.e. 8–12 weeks) regimens has revolutionized the field of HCV treatment and led to the development of global elimination goals for HCV transmission and mortality. However, information on their safety during pregnancy and efficacy in preventing mother-to-child transmission is lacking. Currently, there are no approved treatment regimens with these antiviral agents for children younger than 12 years of age.

Expert commentary: If these agents are shown to be safe during pregnancy and effective in preventing transmission to the infant, screening of pregnant women and antenatal treatment of those infected, could pave the way for eliminating pediatric HCV infection- particularly as these drugs become less costly and more accessible. Treatment of infected children when indicated, along with universal safe health care practices, can further pediatric HCV elimination.