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• W1566859823 abstract "Cured yesterday of my disease, I died last night of my physician. (Prior 1714) This issue explores the diversity of adverse events and their prevention. Adverse events (AEs) have been variously defined as: any event or circumstance leading to unintentional harm or suffering (National Patient Safety Agency (NPSA) 2007 p.13); injury resulting from a medical intervention, not due to the underlying condition of the patient (Kohn et al. 1999 p.4); any untoward medical occurrence in a person, patient or clinical investigational subject administered a pharmaceutical product, importantly the event may not necessarily be related to this treatment. This can include unfavourable and unintended signs (abnormal laboratory findings) symptoms or disease (International Conference on Harmonisation 1996 p.2). These definitions are not entirely congruent: while some authors specify a relationship to a healthcare intervention (Kohn et al. 1999), others are ambivalent regarding attribution (International Conference on Harmonisation 1996, National Patient Safety Agency (NPSA) 2007). ‘Adverse events’ research came to prominence when the Institute of Medicine reported that in-hospital medical errors alone killed more people than HIV/AIDS, breast cancer or motor vehicle accidents (Kohn et al. 1999). It is estimated that adverse events affect 9.2% (IQR 4.6–12.4%) of those admitted to hospital (n = 74 485 patients, eight studies) (de Vries et al. 2008) and 0.1–65.4% patients across the various healthcare settings, with little difference between countries, settings and specialities (23 696 252 patients 156 studies) (Lessing et al. 2010). A higher incidence is reported amongst elderly patients (n = 1006) (Sari et al. 2008). These figures are based mainly on retrospective record reviews, supplemented by voluntary reports in some instances. As health care professionals work towards caring and curing, there can be unintended consequences for patients and professionals. Some of these are well known, while others are unsuspected or obscured by context, familiarity and the clinical perspective. The papers by Holmes & Murray and Morgan et al. are important here. Holmes and Murray’s original and insightful paper echoes Illich’s (1976) admonitions regarding the iatrogenic potential of medicine. Transgenerational adverse drug reactions are also easily overlooked. Thalidomide was withdrawn from sale in 1962, after over 10 000 children had been born with birth defects, mainly limb reductions (Mitchell 2003), but drug-related congenital anomalies continue to occur. The incidence of these is uncertain, and further research is underway (Morgan et al. this issue). Practitioners and women seeking evidence-based advice and guidance are acutely aware that there is even less information available on the impact of drugs in pregnancy on premature birth or the long-term effects of exposure to drugs via breastmilk. It is estimated that 43% (IQR 39.4–49.6%) of in-hospital adverse events are preventable (de Vries et al. 2008). For nurses, the key question is ‘how?’ Even if unrelated to cost-containment or industry sources (Institute of Medicine 2009, Grol 2010), guidelines alone are not enough. A guideline-practice gap is frequently evident, and patient safety strategies, including patient identity (ID) applications and full labelling of medicines, are omitted in many European hospitals (Suñol et al. 2009). However, there is little evidence that, even when implemented, guidelines and many safety initiatives, improve outcomes, although they improve the process of care (Grol 2001, Jordan et al. 2003, Dückers et al. 2009). Over a third (39.5%, IQR 31.5–50.2%) of adverse events are associated with surgery, including post-operative recovery (de Vries et al. 2008). Critically ill patients on busy, general wards are uniquely vulnerable. Could AEs be prevented by increased nursing vigilance? What is the evidence from randomised controlled trials underpinning the familiar observation charts? Surprisingly little, according to Kyriacos et al. Of all vital signs recorded, respiratory rate is the most effective predictor of physiological deterioration (Subbe et al. 2003), yet it is the most frequently omitted (Chellel et al. 2002). Busy nurses have time to record heart rate and blood pressure from automated devices, but not to observe the patient’s chest for a full minute. Patients can suffer serious adverse events if subtle signs of physiological deterioration are overlooked (Smith 2005), and, if nurses do not have even a minute to spend with the patient to record respiratory movements, pallor, nausea and restlessness will also be overlooked. Of the ten cases, nine fatal, of substandard care reported by the Health Service Commissioner for England (2011), four relate to failure to assess elderly patients. There is evidence that adverse events are fewer and patient survival is higher in hospitals with higher nurse to patient ratios (Aiken et al. 2002, 2003, Rafferty et al. 2007). The papers by Kyriacos et al., Gibson et al., Kwan et al., Yuan and Kuo, and Hoga et al. suggest some reaons for this, including inadequate staff numbers, supervision of novice nurses or education and fatigue. Nurses have traditionally monitored patients according to doctors’ instructions, but the medical gaze is not always sufficiently holistic. The papers by Nash and Hemmingway et al. illustrate the importance of broadening the nursing gaze when caring for clients with long-term mental illness. Here, and elsewhere (Nash 2010), Nash argues that the key to improving the physical health of those with long-term mental illness, and reducing their life-expectancy deficit, currently estimated at over 20 years (Tiihonen et al. 2009), is expanding nursing roles to manage diabetes and other aspects of cardiovascular risk. It has been suggested that medicine cures and nursing cares. The traditional medical model has little room for adverse events and adverse drug reactions: the cure is not expected to be worse than the disease. However, caring paradigms encompass adverse events, whether treatment-related or spontaneous. How willing are nurses to translate traditional ‘watchful vigilance’ into structured, detailed and diligent patient monitoring for adverse events? Even if adverse event monitoring fits with nursing roles in theory, is there sufficient time for this in practice? Drug related incidents account for 15.1% (IQR 11.9–20.4%) of adverse events (de Vries et al. 2008). Medication errors continue to account for around 11% (123 795 of 1 157 380) adverse incidents in England and Wales voluntarily reported to the UK National Patient Safety Agency (National Patient Safety Agency (NPSA) 2011), and around two-thirds of care home residents are exposed to medication errors (Barber et al. 2009). The contents of this issue suggest these attract considerable attention. The medical advances of the latter half of the 20th century produced drugs powerful enough to correct pathophysiological disturbance; however alteration in physiology may be at the cost of unintended, adverse consequences. Many adverse drug reactions (ADRs) are well-known and, with good monitoring, are preventable. However, international review indicates that preventable ADRs account for some 3.7% hospital admissions (Howard et al. 2007). We (Gabe et al., Macedo et al., Kwan et al., Hemmingway et al., and Hoga et al.) contend that ADRs are a nursing concern (Kelly 2000): as the professionals closest to the patients, nurses are uniquely placed to monitor all ill-health, including ADRs. Of the 10 cases of substandard care singled out by the Health Service Commissioner for England (2011), two relate to failure to monitor prescribed medicines. Checklists can minimise adverse events (Jordan et al. 2002, Montesi & Lechi 2009, de Vries et al. 2010). Pilot nurse-led work has shown this to be feasible and effective, uncovering previously unsuspected problems in 19 of 20 service users, including cardiac dysrhythmias, severe hypertension and postural hypotension (Jordan et al. 2002). However, further exploration of clinical effectiveness is dependent on further funding. While researchers might like to reflect the totality of practice, they are constrained by resources, institutional approvals, the inevitable trade off between questionnaire length and response rate (Edwards et al. 2009), and even the focus of their expertise. Tensions exist between knowledge generated by research, often focussed on a single problem, and practice, with multiple tasks and complex patients, requiring immediate attention within an holistic frame of reference. Practitioners need to know all the outcomes of the interventions they deliver, benefits and harms, while research may focus on incremental gain in a limited number of outcomes. Traditionally, this hiatus between research and practice has been mediated by scholarship, centring on educators, textbooks, practice development reviews and professional journals. Accordingly, the role of education in linking research to practice, to pre-empt adverse events, is central to this issue (Logan, Nash, Gibson, Hoga et al., Kyriacos et al., Hemingway et al., Jordan & Reid 1997). However, there are concerns that scholarship, integrating new evidence into practice and optimising patient safety, is under-valued and under threat (Rolfe 2009). Not even the most subtle and skilled analysis can overcome completely the unreliability of basic data. (Allen 1957 p.14) The true extent of adverse events and the degree of preventability may never be known. Identification and reporting of adverse events are vulnerable to clinicians’ interpretations of their observations: adverse events may not be identified or attributed to medical interventions if they are common occurrences, not contemporary with administration of the intervention, or occur rarely (Ray 2003). Analysis of 1006 hospital admissions to a UK hospital found that six of 136 (4.4%) adverse events causing harm were recorded on the routine reporting system and 130 were not (Sari et al. 2007). Reporting mechanisms are not necessarily consistent between hospitals; both voluntary and mandatory incident reporting may under-estimate the true extent of problems (Farley et al. 2008). Doctors may regard reporting mechanisms as unresponsive, ineffectual and excessively bureaucratic, leading to irregular, inconsistent under-reporting, and, consequently, unreliable data (Shojania 2008): most adverse event reporting is undertaken by nurses or other non-medical staff (Farley et al. 2008). AE detection and research rely on reporting and documentation. The value of anonymised centralised records, such as congenital anomalies databases, depends on the completeness of reporting and documentation by health care professionals and coding strategies. For example, data analysis by ICD10 codes (World Health Organisation 2011) underestimates the incidence of adverse events (Lessing et al. 2010). Interrogation of comprehensive centralised databases would permit identification of incipient problems and clusters and equitable monitoring of progress and services. It is estimated that a database with a cohort of just 1000 women, including 2% users, would have curtailed the thalidomide disaster at 20 cases (Irl & Hasford 2000). Human error is a preventable component of many adverse events. Nurses, like most humans, make mistakes and errors occur. Practitioners in developing and transitional countries prioritise identification, development and testing of locally effective and affordable solutions to patient safety (Bates et al. 2009). Our contributors, practitioners and researchers outside metropolitan centres, where the professional skill-mix of the workforce may be different, would concur (Logan et al., Jones & Jordan 2010, Coburn et al. 2004, Wholey et al. 2004, Thornlow 2008). Some contributors propose solutions to the perennial problem of adverse events: these centre on nurses’ access to information and education. While Hemmingway et al. are pioneering an education intervention, Hudson et al. report on the introduction of personal digital assistants (PDAs). The prominence of knowledge in the adverse events literature raises questions as to the provenance of adverse events. Logan and Angel’s insightful paper highlights the divorce between scientific reasoning and task-orientation engendered by time pressures, and like Nash, Kyriacos et al., Hemmingway et al. indicates that the shift away from the biological basis of nursing (Jordan 1994) should be reconsidered so that nurses can ‘recognise that something isn’t right and take it up a step’ (Logan and Angel). As Kwan et al. indicate, drug errors occur in all settings, and are under-reported. Interestingly, this paper suggests that, in routine practice, computerised prescribing systems appeared to make little difference to medication errors. Nurse-led approaches are needed (Gabe et al.). Well-conducted trials have shown that large scale ‘top down’ patient safety initiatives have failed to improve patient outcomes (Benning et al. 2011a,b), and greater returns on investment may be available from smaller, local research initiatives, as described here. Most papers in this issue relate to local, small scale work or doctoral theses, with relatively little support from external funding Therefore, their position in the traditional ‘hierarchy of evidence’, which prioritises randomised controlled trials and relegates observational and case study work (Schulz & Grimes 2006), is likely to be low. This reflects the difficulty of obtaining substantial funding for large projects and randomised controlled trials for investigation of adverse events (Herxheimer & Sanz 2008). One of the 158 current grants listed in the UK Medical Research Council’s current portfolio (Medical Research Council (MRC) Research Portfolio 2011), one of over 150 primary research projects listed as ‘research in progress’ by the National Institute of Healthcare Research Health Technology Assessment programme (National Institute of Health Research 2011a) and none on the Service Delivery and Organisation programme project portfolio (National Institute of Health Research 2011b) appear to be devoted to the investigation of adverse drug reactions. Meanwhile, adverse drug reactions are estimated to account for 4% of UK hospital bed occupancy and 1 in 16 admissions (Pirmohamed et al. 2004). Due to the paucity of adverse event data from clinical trials (Ioannidis & Lau 2001), and the potential for reporting to be influenced by research sponsors (Golder & Loke 2008), opinion leaders argue that the ‘hierarchy of evidence’ cannot be applied to adverse event research (Loke et al. 2007). Database explorations may represent the best or even the only evidence available for decision-making in practice (Chou et al. 2010). Case studies are particularly important in highlighting problems (Health Service Commissioner for England 2011) and identifying unsuspected or rare adverse drug reactions: thalidomide-related limb reductions and anaesthetic-induced hepatitis were uncovered by case reports (Aronson & Ferner 2003). Identification of adverse events and adverse drug reactions is a socially contingent process (Corrigan 2002). Recognition is more difficult where effects are trans-generational, delayed, commonplace or associated with drug withdrawal and practitioners are busy. Confusion, slowing of cognition, falls or loss of continence control may be overlooked or attributed to ageing, rather than drugs prescribed for mental illness (Iyer et al. 2008); failure to breastfeed may be attributed to ‘cultural variables’ rather than poor latching and intrapartum medication (Jordan et al. 2005). Reviewers face additional challenges: research databases are arranged to facilitate information retrieval on positive outcomes, complicating identification of papers relating to adverse events (Golder & Loke 2009). In 2001, it was estimated that adverse events cost the NHS around £1 billion per year in extra bed-days alone (Vincent et al. 2001). There are similar concerns throughout the developed world, where litigation is now a significant proportion of health service costs. The number of claims received by the UK NHS Litigation Authority continues to increase, and exceeded 10 000 in 2009/10: over £800 000 000 was paid out in that year (NHS Litigation Authority 2010). Although the true extent of the problem is uncertain, it has been estimated that twice as many people die from medical errors as from breast cancer or motor vehicle accidents or HIV/AIDS (Kohn et al. 1999), and record review indicated that 46 of 1014 (3.6%) of UK in-patients suffered moderate or permanent impairment as a result of adverse events (Vincent et al. 2001); meta-analysis of studies across the developed world yielded similar figures (de Vries et al. 2008). However, funding for adverse events’ research remains elusive (Herxheimer & Sanz 2008). Unless the education and research agendas prioritise equipping nurses and midwives with the evidence on which to base safe practice, the situation may continue to deteriorate. This issue illustrates the persistence of ‘adverse events’ across all healthcare settings, suggesting that we may be expecting too much of nurses, whilst denying nursing research the opportunity to realize its potential. I should like to acknowledge the help and support of Professor Melanie Jasper, Head of College, and Howard Griffiths, Clinical Tutor, College of Human and Health Sciences, Swansea University, in preparing this edition." @default.
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• W1566859823 title "Adverse events: expecting too much of nurses and too little of nursing research" @default.
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