The role of nurses in preventing adverse events related to respiratory dysfunction: literature review

Aims. This paper reports a literature review examining the relationship between specific clinical indicators of respiratory dysfunction and adverse events, and exploring the role of nurses in preventing adverse events related to respiratory dysfunction.

Background. Adverse events in hospital are associated with poor patient outcomes such as increased mortality and permanent disability. Many of these adverse events are preventable and are preceded by a period during which the patient exhibits clearly abnormal physiological signs. The role of nurses in preserving physiological safety by early recognition and correction of physiological abnormality is a key factor in preventing adverse events.

Methods. A search of the Medline and CINAHL databases was conducted using the following terms: predictors of poor outcome, adverse events, mortality, cardiac arrest, emergency, oxygen, supplemental oxygen, oxygen therapy, oxygen saturation, oxygen delivery, assessment, patient assessment, physical assessment, dyspnoea, hypoxia, hypoxaemia, respiratory assessment, respiratory dysfunction, shortness of breath and pulse oximetry. The papers reviewed were research papers that demonstrated a relationship between adverse events and various clinical indicators of respiratory dysfunction.

Results. Respiratory dysfunction is a known clinical antecedent of adverse events such as cardiac arrest, need for medical emergency team activation and unplanned intensive care unit admission. The presence of respiratory dysfunction prior to an adverse event is associated with increased mortality. The specific clinical indicators involved are alterations in respiratory rate, and the presence of dyspnoea, hypoxaemia and acidosis.

Conclusions. The way in which nurses assess, document and use clinical indicators of respiratory dysfunction is influential in identifying patients at risk of an adverse event and preventing adverse events related to respiratory dysfunction. If such adverse events are to be prevented, nurses must not only be able to recognise and interpret signs of respiratory dysfunction, but must also take responsibility for initiating and evaluating interventions aimed at correcting respiratory dysfunction.

Reducing adverse events in older Australians taking newly released drugs

The number of older Australians with one or multiple chronic diseases is increasing. This thesis presents a model to assist in identifying current older patients with multiple illnesses and taking multiple medications who are at risk of experiencing an adverse drug reaction if they are prescribed a newly released drug.

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians : a model process

Background
The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients.

Methods
The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug.

Results
Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug.

Conclusions
Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.

Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).

Randomised controlled trials and 'unexpected' adverse events associated with newly released drugs : improvements in pharmacovigilance systems are necessary for real-time identification of patient safety risks

Adverse drug events are one of the major causes of morbidity in developed countries, yet the drugs involved in these events have been trialled and approved on the basis of randomised controlled trials (RCTs), regarded as the study design that will produce the best evidence.

Though the focus on adverse drug events has been primarily on processes and outcomes associated with the use of these approved drugs, attention needs to be directed to the way in which the RCT study design is structured. The implementation of controls to achieve internal validity in RCTs may be the very controls that reduce external validity, and contribute to the levels of adverse drug events associated with the release of a new drug to the wider patient population.

An examination of these controls, and the effects they can have on patient safety, underscore the importance of knowing about how the clinical trials of a drug are undertaken, rather than relying only on the recorded outcomes.

As the majority of new drugs are likely to be prescribed to older patients who have one or more comorbidities in addition to that targeted by a new drug, and as the RCTs of those drugs typically under-represent the elderly and exclude patients with multiple comorbidities, timely assessment of drug safety signals is essential.

It is unlikely that regulatory jurisdictions will undertake a reassessment of safety issues for drugs that are already approved. Instead, reliance has been placed on adverse drug event reporting systems. Such systems have a very low reporting rate, and most adverse drug events remain unreported, to the eventual cost to patients and healthcare systems.

This makes it essential for near real-time systems that can pick up safety signals as they occur, so that modifications to the product information (or removal of the drug) can be implemented.

Examining adverse events after intensive care unit discharge : outcomes from a pilot questionnaire

Adverse events are common in acute clinical settings but little is known about these events occurring after Intensive Care discharge. This study aimed to develop a reliable and valid tool for exploring clinicians’ opinions of factors associated with post-Intensive Care adverse events. A convenience sample of Australian Intensive Care Liaison Nurses was invited to complete and appraise a questionnaire using structured guidelines. Content validity and internal consistency were assessed.

Twelve Intensive Care Liaison Nurses completed the questionnaire. Cronbach?s alpha coefficient showed high internal consistency for the questionnaire; all 24 items on the questionnaire had coefficients greater than 0.852. The content validity index of the questionnaire overall was 0.76.

The post-Intensive Care adverse events questionnaire demonstrated reliability and validity. It is a tool that can be used to explore clinicians? opinions of factors associated with these events. The tool is important as it facilitates further insight into the causes of post-Intensive Care adverse events.

Using patients' experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above

Evidence of patients' experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia.

Mood stabilizers and treatment adherence in bipolar disorder: addressing adverse events.

Adverse events associated with lithium and anticonvulsant use in patients with bipolar disorder have been determined to decrease rates of treatment adherence; however, research that explores how adverse events influence treatment adherence, and which events have the greatest impact, is sparse and limited. This paper reviews the existing literature regarding common side effects encountered with lithium and anticonvulsant use in patients with bipolar disorder and presents data regarding their impact on treatment adherence. Guidelines for reducing and limiting adverse events are highlighted, as are recommendations for improving compliance associated with the experience of adverse events in the bipolar disorder population.

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process

BACKGROUND: The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. METHODS: The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. RESULTS: Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. CONCLUSIONS: Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).

The missing evidence: a systematic review of patients' experiences of adverse events in health care

PURPOSE: Preventable patient harm due to adverse events (AEs) is a significant health problem today facing contemporary health care. Knowledge of patients' experiences of AEs is critical to improving health care safety and quality. A systematic review of studies of patients' experiences of AEs was conducted to report their experiences, knowledge gaps and any challenges encountered when capturing patient experience data. DATA SOURCES: Key words, synonyms and subject headings were used to search eight electronic databases from January 2000 to February 2015, in addition to hand-searching of reference lists and relevant journals. STUDY SELECTION: Titles and abstracts of publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. DATA EXTRACTION: Data on design, methods and key findings were extracted and collated. RESULTS: Thirty-three publications demonstrated patients identifying a range of problems in their care; most commonly identified were medication errors, communication and coordination of care problems. Patients' income, education, health burden and marital status influence likelihood of reporting. Patients report distress after an AE, often exacerbated by receiving inadequate information about the cause. Investigating patients' experiences is hampered by the lack of large representative patient samples, data over sufficient time periods and varying definitions of an AE. CONCLUSION: Despite the emergence of policy initiatives to enhance patient engagement, few studies report patients' experiences of AEs. This information must be routinely captured and utilized to develop effective, patient-centred and system-wide policies to minimize and manage AEs.

Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

Objectives: The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. Methods: Data were sourced from the Australian Therapeutic Goods Administration (TGA) Database of Adverse Event Notifications between June 2009 and May 2014. Records of haemorrhagic adverse events in which rivaroxaban or dabigatran was considered as a potential cause were analysed. Results: There were 240 haemorrhagic adverse events associated with rivaroxaban and 504 associated with dabigatran. Age was specified for 164 (68%) haemorrhages associated with rivaroxaban, of which 101 occurred in people aged ⩾75 years. Age was specified for 437 (87%) haemorrhages associated with dabigatran, of which 300 occurred in people aged ⩾75 years. Time from treatment initiation to haemorrhage was specified for 122 (51%) haemorrhages associated with rivaroxaban, with 69 (57%) haemorrhages occurring within 30 days of rivaroxaban initiation. Time from treatment initiation to haemorrhage was specified for 253 (50%) haemorrhages associated with dabigatran, with 123 (49%) haemorrhages occurring within 30 days of dabigatran initiation. Gastrointestinal (GI) haemorrhages were the most frequent type of haemorrhages associated with both rivaroxaban (n = 105, 44%) and dabigatran (n = 302, 60%). Data were available on the severity of haemorrhage for 101 (42%) haemorrhages associated with rivaroxaban, with haemorrhage leading to death in 17 people. The severity of haemorrhage was specified for 384 (76%) haemorrhages associated with dabigatran, with haemorrhage leading to death in 61 people. Conclusions: Our study highlights the need for research on the haemorrhagic complications of anticoagulation in clinical care. A considerable proportion of reported haemorrhagic events occurred within 30 days of rivaroxaban and dabigatran initiation. This highlights the importance of considering bleeding risk at the time of treatment initiation.

Prevalence of cardiovascular and metabolic events in patients prescribed clozapine: a retrospective observational, clinical cohort study

BACKGROUND: The efficacy of clozapine for the treatment of schizophrenia has been demonstrated. However, a range of adverse events have been associated with its use. To date, there remains a paucity of data regarding the prevalence of clozapine-induced cardiovascular (CV) and parameters associated with the development of metabolic syndrome, alongside associated risk factors for their development. METHODS: An observational, clinical cohort study design of 355 clozapine patients who were enrolled in the Barwon Health Clozapine Program at Geelong Hospital, Victoria, Australia, between 2008-12. Medical records were accessed retrospectively. Multivariate logistic regression was used to determine associations with adverse event(s). RESULTS: Older age of commencement with clozapine was consistently associated with increased risk of CV abnormalities, with the exception of tachycardia where older age was protective (Odds Ratio [OR]: 0.97; 95% Confidence Intervals [CI]: 0.95, 0.99). Males had significantly greater odds of most metabolic disturbances with the exception of being obese (BMI: ≥30 OR: 0.45; 95% CIs: 0.24, 0.85). Older age of commencement was a significantly associated variable with High- Density Lipoprotein-cholesterol (OR: 1.03; 95% CIs: 1.01, 1.07) and fasting glucose (OR:1.04; 95% CIs: 1.02, 1.07). An increase in BMI was consistently and significantly associated with all metabolic events. CONCLUSION: Male patients who are obese at any point during treatment and older at treatment commencement may be the most vulnerable to adverse CV and metabolic events. While future studies using a matched case-control design may be required to verify these findings, we recommend that treating clinicians consider these risks when assessing patient suitability to clozapine therapy.

Using complemenatry therapies wisely in older people.

Key points
• Over 30%, of older people use complementary therapies.
• Nurses need to be able to use complementary therapies safely if indicated and provide objective. accurate information about them.
• Complementary therapies can be used with conventional medical treatment to improve diabetes balance and quality of life.
• Herb-drug and herb-herb interactions and other adverse events can occur when conventional and complementary therapies are combined inappropriately.
• Complementary therapy use and the reasons for their use should be ascertained when taking a routine history and assessment.

Giving content to the principle of proportionality: happiness and pain as the universal currency for matching offence seriousness and penalty severity

The principle of proportionality prescribes that the punishment should equal the crime. It is one of the most important principles of sentencing. Yet, despite its widespread acceptance it offers no meaningful guide to sentencing. Hence penalty levels fluctuate greatly between jurisdictions and within jurisdictions. This is because there is no universally agreed criterion for measuring offence seriousness or penalty severity. This article suggests that the appropriate criteria for matching offence seriousness and penalty severity is the level of unhappiness or pain stemming from each of these impositions. Thus, for example, the level of pain meted out to a rape offender should equal the level of pain caused to a rape victim. Emerging scientific studies on human well-being and happiness show that human beings are similarly built in terms of the experiences that are either conducive or inimical to well-being. This commonality provides a strong foundation to be confident to make reasonably accurate predictions concerning the extent to which adverse events, such as being the victim of a criminal offence or subjected to a form of criminal sanction will stifle human flourishing. This will then allow us to match accurately offence seriousness and penalty level.

Effect of a self-directed learning package on emergency nurses` knowledge of assessment of oxygenation and use of supplemental oxygen

Abstract Emergency nurses frequently and independently make decisions regarding supplemental oxygen. The importance of these decisions for patients is highlighted by the well documented association between respiratory dysfunction and adverse events. This study aimed to: (i) examine the effect of educational preparation on emergency nurses' knowledge of assessment of oxygenation, and the use of supplemental oxygen; (ii) explore the impact of existing knowledge on decisions related to the implementation of supplemental oxygen; and (iii) explore nurses' characteristics that were associated with effectiveness of the educational preparation. A pretest/post-test, controlled, quasi-experimental design was used in this study. Educational preparation was effective in increasing emergency nurses' knowledge. Baseline level of knowledge was predictive of reports of independent decisions regarding the implementation of oxygen. There was a significant positive relationship between postgraduate qualification in emergency nursing and the effect of education, and significant negative relationships between effect of education and baseline level of knowledge and daily decisions to implement supplemental oxygen.