Clinical risk management and the ethics of open disclosure : part 1 : benefits and risks to patient safety

Patient safety experts and other authorities have strongly postulated the open disclosure of errors and adverse events to patients as an essential component of effective clinical risk management in health care. Commentators also contend that ‘when things go wrong’, openly disclosing such events to the patient and his or her nominated support person is simply ‘the right thing to do’. Despite the obvious importance of the issue of open disclosure and its possible implications for the nursing profession, it has not been comprehensively addressed in the nursing literature. A key aim of this article (the first of a two-part discussion) is to contribute to the positive project of redressing this oversight by providing a brief overview of what open disclosure is and what its intended purpose, aims, and rationale are. Consideration is also given to the risks and benefits of open disclosure as a public policy and whether it will succeed in achieving the anticipated outcomes envisaged. In a second article (to be presented as Part II), the ethics of open disclosure and its possible implications for the nursing profession are explored.

Financial safety nets: reconstructing and modelling a policymaking metaphor

This paper explains that financial safety nets exist because of difficulties in enforcing contracts and shows that elements of deposit-insurance schemes differ substantially across countries. It shows that differences in the design of financial safety nets correlate significantly with differences in the informational and contracting environments of individual countries and that a country's GDP per capita is correlated with proxies for a country's level of: (1) informational transparency, (2) contract enforcement and deterrent rights, and (3) accountability for safety net officials. The analysis portrays deposit insurance as a part of a country's larger safety net and contracting environment. This means that there is no universal method for preventing and resolving banking problems and that the structure of a country's safety net should evolve over time with changes in private and government regulators' capacity for valuing financial institutions, disciplining risk taking and resolving insolvency promptly, and for being held accountable for how well they perform these tasks.

Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): a randomised control trial

Objectives To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.
Design Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
Setting 20 orthopaedic surgery centres in Australia and New Zealand.
Participants 902 patients undergoing elective primary or revision total hip replacement surgery.
Intervention 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
Main outcome measures Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).
Results There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
Conclusions These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
Trial registration NCT00145730.

Special report : the wellbeing of Australians : groups with the highest and lowest wellbeing in Australia

Overview and Aim
1. This report concerns an analysis of the cumulative data from 15 surveys using the Personal Wellbeing Index to measure Subjective Wellbeing. The total number of respondents is about 30,000 but not all data were available for all analyses due to changing variables between
surveys.
2. The aim of this analysis is to determine those sub-groups with the highest and the lowest wellbeing.
Method
3. The definition of sub-groups is through the demographic variables of Income, Gender, Age, Household Composition, Relationship Status and Employment Status. Index domains are also included. While not every combination of demographic variables has been tested, the total number of combinations analysed was 3,277.
4. Extreme group mean scores are defined as lying above 79 points and below 70 points. These values are at least five standard deviations beyond the total sample mean score and are, therefore, extreme outliers. The minimum number of responses that could form such a group is
one. Data are accumulated across surveys for corresponding groups.
Results
5. The initial search for the most extreme groups identified the 20 highest and the 20 lowest groups with a minimum N=10. These are termed the ‘Exclusive’ groups since they were based only on the previously identified extreme scores. In order to determine the true mean of each of these groups, a further analysis incorporated all respondents who met the definition of group membership. For example, an Exclusive group defined as [male, 76+ years] would contain only the accumulation of scores from individual surveys that met the extreme score criterion (<70 or >79). The Inclusive group included the scores from all survey respondents who matched the group definition of male, 76+ years.
6. The results revealed a dominance by the domains of the Personal Wellbeing Index. The extreme high groups were predicted by high scores on all domains except safety and relationships. The low groups were defined by low scores on all seven domains.
7. A further search for extreme groups was undertaken that was restricted to the demographic descriptors. The 20 highest and 20 lowest groups were identified based on a minimum cell content of N=10. The corresponding Inclusive group means were then calculated as before.
8. In order to increase the reliability of the final groups, a minimum cell content of N=20 cases was imposed.
9. Six extreme high groups were identified. These are dominated by high income and the presence of a partner. Five extreme low groups were identified. These are dominated by very low income, the absence of a partner, and unemployment.
Conclusions
10. The conclusions drawn from these analyses are as follows:
10.1 The central defining characteristics of people forming the extreme high wellbeing groups is high household income and living with a partner.
10.2 The central defining risk factors for people forming the extreme low wellbeing groups are very low household income, not living with a partner, and unemployment.
10.3 None of these five demographic characteristics are sufficient to define extreme wellbeing groups on their own. They all act in combinations of at least two risk factors together.

Interlink decision making index (IDMI) -- a simple tool/concept to assist decision making for sustainability Part 1: definition of IDMI

There is an apparent gap between the LCA or other assessment's outcomes and its effective application in the decision making process. It is needed to provide to the decision makers a simple, less human interfered mechanism that integrates all the key criteria (environmental, economic, technical and safety etc.). The proposed index: Interlink Decision Making Index (IDMI) has all these features: simple, interlink (all criteria) and automatically and quantified influence of critical criteria (ie. no human weighting needed) and is able to assist the multi-criteria decision making for sustainability based on the outcomes of specific assessments (eg. LCA, ElA etc.). The index represents a pure numerical value and does not necessarily have any physical meanings, but it reflects the total merits of a particular option once the normal decision making criteria and (up to two) critical criteria (CC) have been chosen. Then, without arbitrarily weighting process, the comparison and selection of the best possible option, ie. decision can be made based on the derived IDMI results. Two hypothetical examples are presented in part 2 of the paper to demonstrate the application of the IDMI concept and it's differences with the traditional "tabular method" in the decision making process.

The "HEALTH" model- part 1 : treatment program guidelines for complex PTSD

This paper outlines the development and piloting of the “HEALTH” model for treatment of Complex PTSD in clients who have experienced multiple traumas across childhood and adulthood - particularly child sexual abuse and sexual assault in adulthood. As a guideline-based treatment model, HEALTH outlines six stages of intervention: (1) having a supportive therapist; (2) ensuring personal safety; (3) assisting with daily functioning; (4) self-regulation - learning to manage core PTSD symptoms; (5) treating Complex PTSD symptoms; and, finally, (6) having patience and persistence to enable “ego strengthening”. Using a case study approach, we provide both qualitative and quantitative assessment data for the individuals in the study, all of whom displayed numerous pre-treatment symptoms of Complex PTSD. Such programs are different to standard PTSD treatment programs that focus predominantly on core PTSD symptoms of re-experiencing, avoidance and arousal. The results of this study provided support for the use of guideline-based treatment programs that cater specifically for the needs of those who have suffered long-term/multiple trauma experiences by targeting Complex PTSD symptoms.

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]

Background: Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years.

Design: A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the Roland-Morris Disability Questionnaire; timed 'Up and Go' test; and adverse effects. The presence of new fractures will be assessed by radiographs of the thoracic and lumbar spine performed at 12 and 24 months.

Discussion: The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice.

Trial registration: Australian Clinical Trial Register # [ACTRN012605000079640]

Implementation of a medication guideline to improve medication safety for patients

Although the incidence of medication error remains unknown, in Australian hospitals, they are thought to occur in 5-20 % of drug administrations 1. Not surprisingly, international debate has focused on the mechanisms to improve the safety of patients. Thus a new National Inpatient Medication Chart (NIMC) was endorsed to improve communication and reduce medication errors 2. This study aimed to investigate the documentation practices of clinicians following the implementation of a medication guideline and NIMC.
A pre and post-test design was used to evaluate the adoption of and adherence to the medication guideline at Western Health, an 850 bed healthcare network in Australia. Audits of inpatient medication charts (N=265) were conducted at 3 months prior to and repeated 4 months (N=290) after implementation. The pre-test data was used to formulate an interdisciplinary organizational strategy that included mandatory education for all clinical staff, practice reminders, decision prompts, a telephone hotline for support, an intranet information website and electronically distributed Frequently Asked Questions.
Pre and post implementation audits highlighted areas of potential medication error. The post-test showed an overall trend towards improvement in documentation. There were significant improvements in 4 critical practices: Drug name clear (p=0.0003); Drug dose clear (p=0.0002); Prescribed frequency equals documented frequency (p=0) and; No signature by administrator (p=0).
The majority of documentation errors showed poor attention to detail and would be considered a slip or lapse in skill based judgment 3. Although this study was designed to evaluate documentation practices, future research should include observation methods to increase our understanding of the context behind the judgments such as work place interruptions, skill mix and knowledge levels. While evidence based guidelines enable work, they are not the actual work or substance of patient care. Organisational systems can assist in preventing unconscious aberrations that lead to error.

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures : a randomised double-blind placebo-controlled trial

Background: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures despite limited evidence to support its use. The primary aim of this study was to determine its short-term efficacy and safety in this patient population.

Methods: In a multicentre randomized placebo-controlled trial, participants with one or two painful osteoporotic vertebral fractures < 12 months duration confirmed active by MRI were randomly assigned, stratified by center, gender and duration of symptoms (< or ≥ 6 weeks), to receive vertebroplasty or sham treatment. Primary outcome was overall pain (0–10 scale) at 3 months. Participants, investigators (other than the interventional radiologist) and outcome assessors were blinded to treatment assignment.

Results: 78 participants were enrolled and 73 (36/38 active, 37/40 placebo, 94%) completed 3-month follow up. Vertebroplasty did not show any statistically significant advantage in any measured outcome with 95% confidence intervals indicating no plausible practically important benefits of vertebroplasty over placebo. At 1 week, 1 and 3 months, there were significant improvements in overall pain in both treatment groups (mean improvement (SD): 1.5 (2.5), 2.1 (2.8), 2.3 (2.6), and 1.7 (3.3), 2.5 (2.9), 1.9 (3.4) in the active and placebo groups respectively). Similar improvements in both groups were observed for night and rest pain, function, quality of life and perceived improvement. Eight incident clinical vertebral fractures (3 active, 5 placebo) occurred during 3-month follow up.

Conclusion: We found no evidence of a beneficial effect of vertebroplasty over sham treatment for painful osteoporotic vertebral fractures, 1 week, 1 and 3 months following treatment. [Australian Clinical Trial Register number, ACTRN012605000079640]

The equipping inclusion studies : assistive technology use and outcomes in Victoria ; key findings and policy implications, study 1 - the equipment study, study 2 - the economic study

Approximately one in five of the Australian population lives with disability (AIHW 2006a; ABS 2003). Of these, almost 1.9 million rely on assistive technologies to live independently (Hobbs, Close, Downing, Reynolds & Walker 2009).

Assistive Technology (AT) is defined as,

‘any device, system or design, whether acquired commercially or off the shelf, modified or customised, that allows an individual to perform a task that they would otherwise be unable to do, or increase the ease and safety with which a task can be performed’ (Independent Living Centres Australia n.d).

‘Assistive Technology solutions’ have been defined as entailing a combination of devices (aids and equipment), environmental modifications (both in the home and outside of it), and personal care (paid and unpaid) (Assistive Technology Collaboration n.d).

Despite a large number of Australians relying on AT, there is little data available about life for these Australians, the extent of AT use, or unmet need for AT. Existing research in Australia suggests that aids and equipment provision in Australia is ‘fragmented’ across a plethora of government and non government programs (AIHW 2006a:35). In Victoria, one of the prime sources of government funding for AT is the Victorian Aids and Equipment Program (VAEP) which is a subsidy program for the purchase of aids and equipment, home and vehicle modifications for people with permanent or long term disability. Recent research suggests that waiting times for accessing equipment through the VAEP are high, as is the cost burden to applicants (Wilson, Wong & Goodridge 2006). In addition, there appears to be a substantial level of unmet need (KPMG 2007).

Additionally, there is a paucity of literature around the economic evaluation of AT interventions and solution packages, resulting in little evidence of their cost-effectiveness credentials.

Are safety-related features of the road environment associated with smaller declines in physical activity among youth?

This study examined how objective measures of the local road environment related to safety were associated with change in physical activity (including active transport) among youth. Few longitudinal studies have examined the impact of the road environment on physical activity among children/adolescents in their neighborhoods. Participants were children aged 8–9 years (n=170) and adolescents aged 13–15 years (n=276) in 2004. Data were collected in 2004 and 2006 during followup of participants recruited initially in 2001 from 19 primary schools in Melbourne, Australia. Walking/cycling to local destinations was parent-reported for children and self-reported by adolescents. Moderate-to-vigorous physical activity (MVPA) during nonschool hours was recorded using accelerometers. Road environment features in each participant’s neighborhood (area within 800 m radius of their home) were measured objectively using a Geographical Information System. Linear regression analyses examined associations between road features and changes in active transport (AT) and MVPA over 2 years. Children’s AT increased but MVPA levels decreased in both age groups; on average, younger girls recorded the greatest declines. The number of traffic/pedestrian lights was associated with ΔAT among younger girls (B=0.45, p=0.004). The total length of walking tracks (in meters) was associated with ΔAT among younger girls (B=0.0016, p=0.015) and adolescent girls (B=0.0016, p=0.002). For adolescent boys, intersection density was associated with ΔAT (B=0.03, p=0.030). Slow points were associated with ΔMVPA among younger boys before school (B=1.55, p=0.021), while speed humps were associated with ΔMVPA among adolescent boys after school (B=0.23, p=0.015). There were many associations for adolescent girls: for example, the total length of local roads (B=0.49, p=0.005), intersection density (B=0.05, p=0.036), and number of speed humps (B=0.33, p=0.020) were associated with ΔMVPA during nonschool hours. Safety-related aspects of the built environment are conducive to physical activity among youth and may help stem age-related declines in physical activity. Passive road safety interventions may promote AT and physical activity among less active girls, in particular.

A multi-vector, multi-envelope HIV-1 vaccine

The St. Jude Children's Research Hospital (St. Jude) HIV-1 vaccine program is based on the observation that multiple, antigenically distinct HIV-1 envelope protein structures are capable of mediating HIV-1 infection. A cocktail vaccine comprising representatives of these diverse structures (immunotypes) is therefore considered necessary to elicit lymphocyte populations that prevent HIV-1 infection. This strategy is reminiscent of that used to design a currently licensed and successful 23-valent pneumococcus vaccine. Three recombinant vector systems are used for the delivery of envelope cocktails (DNA, vaccinia virus, and purified protein) and each of these has been tested individually in phase I safety trials. A fourth clinical trial, in which diverse envelopes and vectors are combined in a prime-boost vaccination regimen, has been FDA-approved and is expected to commence in 2007. This trial will continue to test the hypothesis that a multivector, multi-envelope vaccine can elicit diverse 8- and T-cell populations that can prevent HIV-1 infections in humans.