Clinical efficacy and safety of zoledronic acid in osteoporosis and Paget's disease

Osteoporosis and Paget’s bone disease are the most common diseases of the bone. In addition to glucocorticoid treatment, there are many other secondary causes of osteoporosis. Bisphosphonates are used to treat these bone conditions. Zoledronic acid is the most potent bisphosphonate at inhibiting bone resorption. In osteoporosis, zoledronic acid increases bone mineral density for at least 1 year following a single intravenous administration. The efficacy and safety of zoledronic acid in the treatment of osteoporosis and Paget’s bone disease are reviewed. This article also covers the studies of the effects of zoledronic acid in the bone loss associated with the secondary osteoporosis.

Clinical efficacy and safety of zoledronic acid in prostate and breast cancer

The anti-estrogen treatment for hormone-sensitive breast cancer and the androgen deprivation therapy for prostate cancer can lead to the development of osteoporosis and bone fractures. Metastases associated with prostate and breast cancer can also occur in bone. Bisphosphonates are used in these types of bone dysfunction. Zoledronic acid is the most potent bisphosphonate. In osteoporosis, zoledronic acid inhibits bone reabsorption and increases bone mineral density for at least a year after intravenous administration. The efficacy and safety of zoledronic acid in osteoporosis secondary to hormone-sensitive cancers (prostate and breast), and in the bone metastases associated with these cancers are reviewed.

Good clinical endpoints with denosumab in osteoporosis and cancer

Background: Bone loss associated with low oestrogen levels in postmenopausal women, and with androgen deprivation therapy in men with hormone-sensitive prostate cancer, result in an increased incidence of fractures. Denosumab has been shown to increase bone mineral density in these two conditions. Objectives/methods: The objective of this evaluation is to review the clinical trials that have studied clinical endpoints in these conditions. Results: FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) was an International Phase III clinical trial that measured the clinical endpoints with denosumab in postmenopausal women with osteoporosis. At 36 months, new vertebral fractures had occurred in 7.2% of subjects in the placebo group and this was lowered to 2.3% of subjects treated with denosumab. HALT (Denosumab Hormone Ablation Bone Loss Trial) studied the clinical endpoints in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. The incidence of vertebral fractures was significantly lower in the denosumab group (1.5%) than in the placebo group (3.9%). The incidence of adverse effects with denosumab in both clinical trials was low. Conclusions: Denosumab reduces the incidence of fractures in postmenopausal women with osteoporosis and in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. Denosumab is well tolerated.

The impact of health information technology on the quality of medical and health care : a systematic review

Objective: To systematically review the published evidence of the impact of health information technology (HIT) on the quality of medical and health care specifically clinicians’ adherence to evidence-based guidelines and the corresponding impact this had on patient clinical outcomes. In order to be as inclusive as possible the research examined literature discussing the use of health information technologies and systems in both medical care such as clinical and surgical, and other health care such as allied health and preventive services.----- Design: Systematic review----- Data Sources: Relevant literature was systematically searched on English language studies indexed in MEDLINE and CINAHL(1998 to 2008), Cochrane Library, PubMed, Database of Abstracts of Review of Effectiveness (DARE), Google scholar and other relevant electronic databases. A search for eligible studies (matching the inclusion criteria) was also performed by searching relevant conference proceedings available through internet and electronic databases, as well as using reference lists identified from cited papers.----- Selection criteria: Studies were included in the review if they examined the impact of Electronic Health Record (EHR), Computerised Provider Order-Entry (CPOE), or Decision Support System (DS); and if the primary outcomes of the studies were focused on the level of compliance with evidence-based guidelines among clinicians. Measures could be either changes in clinical processes resulting from a change of the providers’ behaviour or specific patient outcomes that demonstrated the effectiveness of a particular treatment given by providers. ----- Methods: Studies were reviewed and summarised in tabular and text form. Due to heterogeneity between studies, meta-analysis was not performed.----- Results: Out of 17 studies that assessed the impact of health information technology on health care practitioners’ performance, 14 studies revealed a positive improvement in relation to their compliance with evidence-based guidelines. The primary domain of improvement was evident from preventive care and drug ordering studies. Results from the studies that included an assessment for patient outcomes however, were insufficient to detect either clinically or statistically important improvements as only a small proportion of these studies found benefits. For instance, only 3 studies had shown positive improvement, while 5 studies revealed either no change or adverse outcomes.----- Conclusion: Although the number of included studies was relatively small for reaching a conclusive statement about the effectiveness of health information technologies and systems on clinical care, the results demonstrated consistency with other systematic reviews previously undertaken. Widescale use of HIT has been shown to increase clinician’s adherence to guidelines in this review. Therefore, it presents ongoing opportunities to maximise the uptake of research evidence into practice for health care organisations, policy makers and stakeholders.

A grounded theory study of nursing students’ experiences in the off-campus clinical setting

Poor workplace relations are an issue of concern in many workplaces and this phenomenon is not restricted to the nursing profession. The issue of workplace violence in nursing is well documented and there are an increasing number of studies which have investigated the notion of horizontal violence amongst graduate nurses. The impact that poor workplace relations has on the development of a professional identity by nursing students in the off-campus clinical setting is significant in light of the current global shortage of nurses. There is a dearth of knowledge in understanding how Australian undergraduate nursing students experience the off-campus clinical setting and subsequently develop a professional identity as a nurse. Therefore the aim of this study was to discover and describe the phenomena in order to develop a substantive theory that explains the experiences of the undergraduate nursing students in a regional setting. Constructivist grounded theory methods were utilised in the conduct of the study. A sample of 29 participants was recruited permitting the formulation of a substantive theory regarding the development of a professional identity in nursing students. This substantive theory contributes knowledge relevant to the undergraduate nursing students, nurse educators, nursing workforce planners, and the tertiary educational institutions offering nursing. This is achieved through discovering, describing and explaining the phenomenon of ‘anxiety’ which the nursing students experience as a result of the interrelationship and interactions of tradition bearing, staff and student performance. These interactions intersect to form expectations of where the student fits within the hierarchy of the facility and the nursing profession in general. An understanding of the issues associated with tradition bearing, staff performance, and student performance and the impact that the interaction of these conditions has upon the student’s developing professional identity as a nurse is necessary to allow for the implementation of corrective strategies.

Clinical whole-body skin examination reduces the incidence of thick melanomas

Survival from melanoma is strongly related to tumour thickness, thus earlier diagnosis has the potential to reduce mortality from this disease. However, in the absence of conclusive evidence that clinical skin examination reduces mortality, evidence-based assessments do not recommend population screening. We aimed to assess whether clinical whole-body skin examination is associated with a reduced incidence of thick melanoma and also whether screening is associated with an increased incidence of thin lesions (possible overdiagnosis). A population-based case-control study of all Queensland residents aged 20-75 years with a histologically confirmed first primary invasive cutaneous melanoma diagnosed between January 2000 and December 2003. Telephone interviews were completed by 3,762 eligible cases (78.0%) and 3,824 eligible controls (50.4%) Whole-body clinical skin examination in the three years before diagnosis was associated with a 14% lower risk of being diagnosed with a thick melanoma (>0.75mm) (OR= 0.86, 95% CI=0.75, 0.98). Risk decreased for melanomas of increasing thickness: the risk of being diagnosed with a melanoma 0.76-1.49mm was reduced by 7% (OR=0.93, 95% CI 0.79, 1.10), by 17% for melanomas 1.50-2.99mm (OR=0.83, 95% CI=0.65, 1.05) and by 40% for melanomas ≥3mm (OR=0.60, 95% CI=0.43, 0.83). Screening was associated with a 38% higher risk of being diagnosed with a thin invasive melanoma (≤0.75mm) (OR=1.38, 95% CI=1.22, 1.56). This is the strongest evidence to date that whole-body clinical skin examination reduces the incidence of thick melanoma. Because survival from melanoma is strongly related to tumour thickness, these results suggest that screening would reduce melanoma mortality.

Public health and clinical dilemmas resulting from imprecise vitamin D tests

Objective: To determine whether there are clinical and public health dilemmas resulting from the reproducibility of routine vitamin D assays. Methods: Blinded agreement studies were conducted in eight clinical laboratories using two commonly used assays to measure serum 25-hydroxyvitamin D (25(OH)D) levels in Australasia and Canada (DiaSorin Radioimmunoassay (RIA) and DiaSorin LIAISON® one). Results: Only one laboratory measured 25(OH)D with excellent precision. Replicate 25(OH)D measurements varied by up to 97% and 15% of paired results differed by more than 50%. Thirteen percent of subjects received one result indicating insufficiency [25-50 nmol/l] and another suggesting adequacy [>50 nmol/l]). Agreement ranged from poor to excellent for laboratories using the manual RIA, while the precision of the semi-automated Liaison® system was consistently poor. Conclusions: Recent interest in the relevance of vitamin D to human health has increased demand for 25(OH)D testing and associated costs. Our results suggest clinicians and public health authorities are making decisions about treatment or changes to public health policy based on imprecise data. Clinicians, researchers and policy makers should be made aware of the imprecision of current 25(OH)D testing so that they exercise caution when using these assays for clinical practice, and when interpreting the findings of epidemiological studies based on vitamin D levels measured using these assays. Development of a rapid, reproducible, accurate and robust assay should be a priority due to interest in populationbased screening programs and research to inform public health policy about the amount of sun exposure required for human health. In the interim, 25(OH)D results should routinely include a statement of measurement uncertainty.

Building the toolkit of quality monitoring clinical outcomes as a means of assessing quality in residential care

Residential aged care in Australia does not have a system of quality assessment related to clinical outcomes, creating a significant gap in quality monitoring. Clinical outcomes represent the results of all inputs into care, thus providing an indication of the success of those inputs. To fill this gap, an assessment tool based on resident outcomes (the ResCareQA) was developed and evaluated in collaboration with residential care providers. A useful output of the ResCareQA is a profile of resident clinical status, and this paper will use such outputs to present a snapshot of nine residential facilities. Such comprehensive data has not yet been available within Australia, so this will provide an important insight. ResCareQA data was collected from all residents (N=498) of nine aged care facilities from two major aged care providers. For each facility, numerator–denominator data were calculated to assess the degree of potential clinical problems. Results varied across clinical areas and across facilities, and rank-ordered facility results for selected clinical areas are reviewed and discussed. Use of the ResCareQA to generate clinical outcome data provides a concrete means of monitoring care quality within residential facilities; regular use of the ResCareQA could thus contribute to improved care outcomes within residential aged care.

Australian nursing informatics competency project

A study of Australian nurses on their use of information technology in the workplace was undertaken by the Australian Nursing Federation (ANF) in 2007. This study of over 4000 nurses highlighted that nurses recognise benefits to adopting more information technology in the workplace although there are significant barriers to their use. It also identified gross deficits in the capacity of the nursing workforce to engage in the digital processing of information. Following the release of the study last year, the ANF commenced work on a number of key recommendations from the report in order to overcome identified barriers and provide opportunities for nurses to better utilise information technology and information management systems. One of these recommendations was to seek research funding to develop national information technology and information management competency standards for nurses. This project has now received Federal Government funding to undertake this development. This project is being developed in collaboration with the ANF and the Queensland University of Technology. This paper will discuss the methodology, development and publication of the Australian Nursing Informatics Competency Standards Project which is currently underway and due for completion in May 2009. The Australian Nursing Informatics Competencies will be presented at the conference.

The impact of Health Information Technology (I-HIT) scale : the Australian results

One of role of the nurse in the clinical setting is that of coordinating communication across the healthcare team. On a daily basis nurses interact with the person receiving care, their family members, and multiple care providers thus placing the nurse in the central position with access to a vast array of information on the person. Through this nurses have historically functioned as “information repositories”. With the advent of Health Information Technology (HIT) tools there is a potential that HIT could impact interdisciplinary communication, practice efficiency and effectiveness, relationships and workflow in acute care settings \[1]\[3]. In 2005, the HIMSS Nursing Informatics Community developed the IHITScale to measure the impact of HIT on the nursing role and interdisciplinary communication in USA hospitals. In 2007, nursing informatics colleagues from Australia, Finland, Ireland, New Zealand, Scotland and the USA formed a research collaborative to validate the IHIT in six additional countries. This paper will discuss the background, methodology, results and implications from the Australian IHIT survey of over 1100 nurses. The results are currently being analyzed and will be presented at the conference.

Continuous infusion of ticarcillin-clavulanate for home treatment of serious infections : clinical efficacy, safety, pharmacokinetics and pharmacodynamics

Continuous infusion (CI) ticarcillin–clavulanate is a potential therapeutic improvement over conventional intermittent dosing because the major pharmacodynamic (PD) predictor of efficacy of β-lactams is the time that free drug levels exceed the MIC. This study incorporated a 6-year retrospective arm evaluating efficacy and safety of CI ticarcillin–clavulanate in the home treatment of serious infections and a prospective arm additionally evaluating pharmacokinetics (PK) and PD. In the prospective arm, steady-state serum ticarcillin and clavulanate levels and MIC testing of significant pathogens were performed. One hundred and twelve patients (median age, 56 years) were treated with a CI dose of 9.3–12.4 g/day and mean CI duration of 18.0 days. Infections treated included osteomyelitis (50 patients), septic arthritis (6), cellulitis (17), pulmonary infections (12), febrile neutropenia (7), vascular infections (7), intra-abdominal infections (2), and Gram-negative endocarditis (2); 91/112 (81%) of patients were cured, 14 (13%) had partial response and 7 (6%) failed therapy. Nine patients had PICC line complications and five patients had drug adverse events. Eighteen patients had prospective PK/PD assessment although only four patients had sufficient data for a full PK/PD evaluation (both serum steady-state drug levels and ticarcillin and clavulanate MICs from a bacteriological isolate), as this was difficult to obtain in home-based patients, particularly as serum clavulanate levels were found to deteriorate rapidly on storage. Three of four patients with matched PK/PD assessment had free drug levels exceeding the MIC of the pathogen. Home CI of ticarcillin–clavulanate is a safe, effective, convenient and practical therapy and is a therapeutic advance over traditional intermittent dosing when used in the home setting.

Development and use of clinical guidelines

The purpose of this chapter is to provide an overview of the development and use of clinical guidelines as a tool for decision making in clinical practice. Nurses have always developed and used tools to guide clinical decision making related to interventions in practice. Since Florence Nightingale (Nightingale 1860) gave us ‘notes’ on nursing in the late 1800s, nurses have continued to use tools, such as standards, policies and procedures, protocols, algorithms, clinical pathways and clinical guidelines, to assist them in making appropriate decisions about patient care that eventuate in the best desired patient outcomes. Clinical guidelines have enjoyed growing popularity as a comprehensive tool for synthesising clinical evidence and information into user-friendly recommendations for practice. Historically, clinical guidelines were developed by individual experts or groups of experts by consensus, with no transparent process for the user to determine the validity and reliability of the recommendations. The acceptance of the evidence-based practice (EBP) movement as a paradigm for clinical decision making underscores the imperative for clinical guidelines to be systematically developed and based on the best available research evidence. Clinicians are faced with the dilemma of choosing from an abundance of guidelines of variable quality, or developing new guidelines. Where do you start? How do you find an existing guideline to fit your practice? How do you know if a guideline is evidence-based, valid and reliable? Should you apply an existing guideline in your practice or develop a new guideline? How do you get clinicians to use the guidelines? How do you know if using the guideline will make any difference in care delivery or patient outcomes? Whatever the choice, the challenge lies in choosing or developing a clinical guideline that is credible as a decision-making tool for the delivery of quality, efficient and effective care. This chapter will address the posed questions through an exploration of the ins and outs of clinical guidelines, from development to application to evaluation.

Enhancing transition : an enhanced model of clinical placement for final year nursing students

Specialised support for student nurses making the transition to graduate nurse can be crucial to successful and smooth adjustment, and can create a path to positive and stable career experiences. This paper describes an enhanced model of final year nursing student placements which was trialled in 2006 at the Queensland University of Technology. The model involved collaboration with two major urban health services and resources were developed to support effective transition experiences. Ninety-two students, including 29 trial participants and 63 non-trial participants were assessed on preparedness for professional practice, before and after the trial semester. Results indicated an increase in preparedness across the entire sample, but students participating in the trial did not differ significantly in overall preparedness change from those who did not participate. Higher baseline preparedness in the trial group highlighted the possibility that proactive students who choose enrichment experiences tend to be likelier to gain benefit from such options than those who do not. Qualitative findings from focus groups conducted with 12 transition group students highlighted that one of the main beneficial aspects of the experience for students was the sense of belonging to a team that understood their learning needs and could work constructively with them.

Clinical results in primary THR

Written by the surgeons of the Exeter Hip Team and their colleagues from around the world, this book describes 40 years of innovation and development with cemented hip replacement. Topics covered include the basic science behind successful cemented hip replacement, modern surgical techniques and recent advances. There is also extensive coverage of the revision techniques developed at Exeter and elsewhere, focussing on femoral and acetabular impaction grafting. Each chapter is a self-contained article with an emphasis, where appropriate, on practical techniques and surgical tips, supported by line drawings and intra-operative photographs.

Clinical results : Acetabular impaction grafting

Written by the surgeons of the Exeter Hip Team and their colleagues from around the world, this book describes 40 years of innovation and development with cemented hip replacement. Topics covered include the basic science behind successful cemented hip replacement, modern surgical techniques and recent advances. There is also extensive coverage of the revision techniques developed at Exeter and elsewhere, focussing on femoral and acetabular impaction grafting. Each chapter is a self-contained article with an emphasis, where appropriate, on practical techniques and surgical tips, supported by line drawings and intra-operative photographs.