The National Naloxone Reference Group: A collective voice on take-home naloxone policy and practice in Australia.

The National Naloxone Reference Group has played a key role in the development of take-home naloxone programs, policy and practice in Australia. In this commentary we detail the origins of the group, some of its main achievements since its inception and its future directions in light of the major policy changes around naloxone that have recently occurred in Australia.

Polyclonal and monoclonal antibodies for induction therapy in kidney transplant recipients.

BACKGROUND: Prolonging kidney transplant survival is an important clinical priority. Induction immunosuppression with antibody therapy is recommended at transplantation and non-depleting interleukin-2 receptor monoclonal antibodies (IL2Ra) are considered first line. It is suggested that recipients at high risk of rejection should receive lymphocyte-depleting antibodies but the relative benefits and harms of the available agents are uncertain. OBJECTIVES: We aimed to: evaluate the relative and absolute effects of different antibody preparations (except IL2Ra) when used as induction therapy in kidney transplant recipients; determine how the benefits and adverse events vary for each antibody preparation; determine how the benefits and harms vary for different formulations of antibody preparation; and determine whether the benefits and harms vary in specific subgroups of recipients (e.g. children and sensitised recipients). SEARCH METHODS: Randomised controlled trials (RCTs) comparing monoclonal or polyclonal antibodies with placebo, no treatment, or other antibody therapy in adults and children who had received a kidney transplant. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing monoclonal or polyclonal antibodies with placebo, no treatment, or other antibody therapy in adults and children who had received a kidney transplant. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias. Dichotomous outcomes are reported as relative risk (RR) and continuous outcomes as mean difference (MD) together with their 95% confidence intervals (CI). MAIN RESULTS: We included 99 studies (269 records; 8956 participants; 33 with contemporary agents). Methodology was incompletely reported in most studies leading to lower confidence in the treatment estimates.Antithymocyte globulin (ATG) prevented acute graft rejection (17 studies: RR 0.63, 95% CI 0.51 to 0.78). The benefits of ATG on graft rejection were similar when used with (12 studies: RR 0.61, 0.49 to 0.76) or without (5 studies: RR 0.65, 0.43 to 0.98) calcineurin inhibitor (CNI) treatment. ATG (with CNI therapy) had uncertain effects on death (3 to 6 months, 3 studies: RR 0.41, 0.13 to 1.22; 1 to 2 years, 5 studies: RR 0.75, 0.27 to 2.06; 5 years, 2 studies: RR 0.94, 0.11 to 7.81) and graft loss (3 to 6 months, 4 studies: RR 0.60, 0.34 to 1.05; 1 to 2 years, 3 studies: RR 0.65, 0.36 to 1.19). The effect of ATG on death-censored graft loss was uncertain at 1 to 2 years and 5 years. In non-CNI studies, ATG had uncertain effects on death but reduced death-censored graft loss (6 studies: RR 0.55, 0.38 to 0.78). When CNI and older non-CNI studies were combined, a benefit was seen with ATG at 1 to 2 years for both all-cause graft loss (7 studies: RR 0.71, 0.53 to 0.95) and death-censored graft loss (8 studies: RR 0.55, 0.39 to 0.77) but not sustained longer term. ATG increased cytomegalovirus (CMV) infection (6 studies: RR 1.55, 1.24 to 1.95), leucopenia (4 studies: RR 3.86, 2.79 to 5.34) and thrombocytopenia (4 studies: RR 2.41, 1.61 to 3.61) but had uncertain effects on delayed graft function, malignancy, post-transplant lymphoproliferative disorder (PTLD), and new onset diabetes after transplantation (NODAT).Alemtuzumab was compared to ATG in six studies (446 patients) with early steroid withdrawal (ESW) or steroid minimisation. Alemtuzumab plus steroid minimisation reduced acute rejection compared to ATG at one year (4 studies: RR 0.57, 0.35 to 0.93). In the two studies with ESW only in the alemtuzumab arm, the effect of alemtuzumab on acute rejection at 1 year was uncertain compared to ATG (RR 1.27, 0.50 to 3.19). Alemtuzumab had uncertain effects on death (1 year, 2 studies: RR 0.39, 0.06 to 2.42; 2 to 3 years, 3 studies: RR 0.67, 95% CI 0.15 to 2.95), graft loss (1 year, 2 studies: RR 0.39, 0.13 to 1.30; 2 to 3 years, 3 studies: RR 0.98, 95% CI 0.47 to 2.06), and death-censored graft loss (1 year, 2 studies: RR 0.38, 0.08 to 1.81; 2 to 3 years, 3 studies: RR 2.45, 95% CI 0.67 to 8.97) compared to ATG. Creatinine clearance was lower with alemtuzumab plus ESW at 6 months (2 studies: MD -13.35 mL/min, -23.91 to -2.80) and 2 years (2 studies: MD -12.86 mL/min, -23.73 to -2.00) compared to ATG plus triple maintenance. Across all 6 studies, the effect of alemtuzumab versus ATG was uncertain on all-cause infection, CMV infection, BK virus infection, malignancy, and PTLD. The effect of alemtuzumab with steroid minimisation on NODAT was uncertain, compared to ATG with steroid maintenance.Alemtuzumab plus ESW compared with triple maintenance without induction therapy had uncertain effects on death and all-cause graft loss at 1 year, acute rejection at 6 months and 1 year. CMV infection was increased (2 studies: RR 2.28, 1.18 to 4.40). Treatment effects were uncertain for NODAT, thrombocytopenia, and malignancy or PTLD.Rituximab had uncertain effects on death, graft loss, acute rejection and all other adverse outcomes compared to placebo. AUTHORS' CONCLUSIONS: ATG reduces acute rejection but has uncertain effects on death, graft survival, malignancy and NODAT, and increases CMV infection, thrombocytopenia and leucopenia. Given a 45% acute rejection risk without ATG induction, seven patients would need treatment to prevent one having rejection, while incurring an additional patient experiencing CMV disease for every 12 treated. Excluding non-CNI studies, the risk of rejection was 37% without induction with six patients needing treatment to prevent one having rejection.In the context of steroid minimisation, alemtuzumab prevents acute rejection at 1 year compared to ATG. Eleven patients would require treatment with alemtuzumab to prevent 1 having rejection, assuming a 21% rejection risk with ATG.Triple maintenance without induction therapy compared to alemtuzumab combined with ESW had similar rates of acute rejection but adverse effects including NODAT were poorly documented. Alemtuzumab plus steroid withdrawal would cause one additional patient experiencing CMV disease for every six patients treated compared to no induction and triple maintenance, in the absence of any clinical benefit. Overall, ATG and alemtuzumab decrease acute rejection at a cost of increased CMV disease while patient-centred outcomes (reduced death or lower toxicity) do not appear to be improved.

Evaluation of a 12-Month Pilot of Long-Term and Temporary Assisted Peritoneal Dialysis.

♦ BACKGROUND: Peritoneal dialysis (PD) is challenging for patients with functional limitations, and assisted PD can support these patients, but previous reports of assisted PD have not examined the role of temporary assisted PD and had difficulty identifying adequate comparator cohorts. ♦ METHODS: Peritoneal Dialysis Assist (PDA), a 12-month pilot of long-term and temporary assisted PD was completed in multiple PD centers in British Columbia, Canada. Continuous cycler PD (CCPD) patients were identified for PDA by standardized criteria, and service could be long-term or temporary/respite. The PDA program provided daily assistance with cycler dismantle and setup, but patients remained responsible for cycler connections and treatment decisions. Outcomes were compared against both the general CCPD population and patients who met PDA criteria but were not enrolled (PDA-eligible). ♦ RESULTS: Fifty-three PDA patients had an 88% 1-year death- and transplant-censored technique survival that was similar to the general CCPD cohort (84%) and PDA-eligible cohort (86%). The PDA cohort had lower peritonitis rates (0.18 episodes/patient-year vs 0.22 and 0.36, respectively), but higher hospitalization (55% vs 34% and 35%, respectively). Long-term PDA cost approximately CDN$15,000/year in addition to existing dialysis costs. A total of 8/11 respite PDA patients (73%) returned to self-care PD after a median PDA use of 29 days, which costs $1,250/patient. ♦ CONCLUSIONS: Peritoneal Dialysis Assist provides effective support to functionally-limited CCPD patients and yields acceptable clinical outcomes. The program costs less than transfer to HD or long-term care, which represents cost minimization for failing self-care PD patients. Respite PDA provides effective temporary support; most patients returned to self-care PD and service was cost-effective compared with alternatives of hospitalization or transfer to HD.

Adult bone anchored hearing aid services in the United Kingdom: building a consensus for development.

AIMS AND OBJECTIVES: In October 2009, a multi-disciplinary group of UK clinicians met to review issues relating to bone-anchored hearing-aid (BAHA) development. The aim was to help define a model for BAHA services and service development via a process of widespread consultation with UK BAHA professionals. METHODS: A modified Delphi technique was used. Statements were proposed by the lead group and sent out for consultation. Those with ≥90% agreement were approved without further discussion. Statements with 50-89% agreement were discussed by the lead group to determine whether they should be included in the final document. Any statement with <50% agreement was removed without discussion. A second consultation was then made, and the process repeated. This led to a final set of consensus statements. RESULTS: The final consensus comprises 33 statements validated by the modified Delphi process. All of these statements achieved >75% agreement, with only six statements having <90% agreement. When these statements were presented to the UK BAHA Professionals group at their annual conference there was 89% agreement from the group for the consensus statements to be accepted. DISCUSSION: The levels of agreement for the final questionnaire show that the mandate for the consensus statements was exceptionally high. Implementation of the consensus is discussed, as are each of the key areas of the consensus, such as funding and minimum assessment standards.

Social care informatics as an essential part of holistic health care: a call for action.

PURPOSE: The authors identified the need for a cross-disciplinary research view of issues to ensure an integrated citizen-centric support to achieve optimal health of individual citizens and, in particular, the role of informatics to inform and coordinate support towards integrated and holistic care. METHOD: An Exploratory Workshop was approved and sponsored by the European Science Foundation. Twenty-three participants from 15 countries attended, covering a full range of health, social care and informatics professions and disciplines. RESULTS: The participants found strong common ground in identifying key issues to be addressed if citizens with compromised health are to receive integrated and coordinated support to a common set of objectives, while also ensuring appropriate choice and support for citizen, family and other informal carers. At the same time, optimal health was identified as a fundamental human right, and that achieving this is a necessary priority of a caring society. Moreover, Europe has a commitment to researching and developing health informatics (e-health), though not yet giving a priority to this integration of health and social care. Specifically the following main informatics challenges to be addressed were identified: (1) to identify available information and communication needs related to different scenarios of use in the intersection between health and social care, (2) to develop and map shared ontologies, and standards for integration and/or brokerage, (3) to enable planned information access and sharing, shaping a system of trust where the patient is an active partner and policies are established considering all partners/interests, (4) to investigate the use of automatic/intelligent knowledge based and context-relevant services, and (5) empowering the citizen (or their selected agent) as co-producer through modern informatics tools, while carefully avoiding selective disempowerment of the most vulnerable. CONCLUSION: The Exploratory Workshop resulted in a unanimous Declaration for action, which is presented appended to this paper.

Social care informatics - the missing partner in ehealth.

To the individual, social care can be an essential part of maintaining health, as is reflected by the WHO definition of health as being one of wellbeing. However, health informatics currently narrowly restricts itself to health organizations' activities. Digital records in social care are increasing, raising the need to recognize the area of social care informatics. This new domain needs support and nurture, whilst the delivery of social and related care needs to be harmonized with healthcare delivery. In turn, this raises important new issues as to how to best support the citizen, especially when they are dependent, including issues of information sharing, service co-ordination, sharing of meaning and objectives, and of respect for autonomy.

The auditory basis of language impairments: temporal processing versus processing efficiency hypotheses.

Claims have been made that language-impaired children have deficits processing rapidly presented or brief sensory information. These claims, known as the 'temporal processing hypothesis', are supported by demonstrations that language-impaired children have excess backward masking (BM). One explanation for these results is that BM is developmentally delayed in these children. However, little was known about how BM normally develops. Recently, we assessed BM in normally developing 6- and 8-year-old children and adults. Results showed that BM thresholds continue to improve over a comparatively protracted period (>10 years old). We also analysed reported deficits in BM in language-impaired and younger children, in terms of a model of temporal resolution. This analysis suggests that poor processing efficiency, rather than deficits in temporal resolution, can account for these results. This 'processing efficiency hypothesis' was recently tested in our laboratory. This experiment measured BM as a function of delays between the tone and the noise in children and adults. Results supported the processing efficiency hypothesis, and suggested that reduced processing efficiency alone could account for differences between adults and children. These findings provide a new perspective on the mechanisms underlying communication disorders, and imply that remediation strategies should be directed towards improving processing efficiency, not temporal resolution.