National Blood Authority

Effective healthcare delivery necessitates evaluation of the effect of interventions in the form of outcome assessment. Treatment effect includes measurement of how the patient feels, functions and survives following healthcare interventions. In haemophilia, which is a rare bleeding disorder, outcome assessment was characterized by a lack of validated outcome measurement tools and the challenges of hemophilia study design to collect outcome data. The aim of this communication is to share current thinking and, through practical examples, provide a state of the art practice in the assessment of hemophilia outcomes from a healthcare provider, patient/family and funder perspective. This discussion is timely and particularly relevant to the care of people with hemophilia on the eve of a number of novel hemophilia treatment products which are about to be licensed for use, specifically the long-acting factor VIII and factor IX concentrates. The first section by Dr Blanchet gives an overview of the tools currently available for assessment of structure/function, patient activities and patient participation in hemophilia healthcare delivery, pointing out the challenge of developing new tools and appropriate validation of currently available tools. The second section by Mr Brian O'Mahony emphasizes the essential collaboration and partnership between healthcare providers and people with hemophilia in collating the outcome data. In the third and final section, Mr Leigh McJames, gives a funder's perspective of the desirable outcomes of hemophilia care.

BACKGROUND: The research literature has documented age-related increases in genetic damage, including oxidative DNA damage, in human T lymphocytes, in vitro and ex vivo. Such damage has the potential to interfere with the ability of the T cells to proliferate at times when they need to, such as when antigen challenged. The consequence of this could be a sub-optimal immune response in vivo. CONTEXT AND PURPOSE: The purpose of the research reported in this paper was to investigate the impact of two antioxidants, which can be administered in vivo, Ebselen and N-acetyl L-cysteine, on the age-related increase in genetic damage, and on T cell proliferation and lifespan. In vitro human T cell clones, ex vivo peripheral blood mononuclear cells or T cells were supplemented with different concentrations of antioxidants, under standard conditions and for different periods of time. A range of assays were then applied in order to determine any impact of the antioxidants. RESULTS: 30 μM ebselen or 7.5 mM N-acetyl L-cysteine supplementation resulted in a significantly higher intracellular GSH: GSSG ratio. This increased ratio was accompanied by reduced levels of oxidative DNA damage in established CD4+ human T cell clones, from a young or a middle-aged donor. Additionally, cultures of primary human peripheral blood mononuclear cells and CD4+ T cells from donors aged 25-30 or 55-60 years were also supplemented with these agents. Cells from all sources exhibited increased proliferation, and in the case of the T cell clones, an increase in cumulative population doublings. Neither ebselen nor N-acetyl L-cysteine had such effects on clones supplemented from the midpoint of their in vitro lifespan. CONCLUSIONS: Ebselen and N-acetyl L-cysteine, under certain conditions, may have anti-immunosenescent potential in T cells in in vitro clonal and ex vivo polyclonal culture models.

striking and highly significant improvement in the clinical outcome at three months was observed in the nimodipine limb.Among all 554 patients, 235 of whom underwent operation, a bleeding event led to nimodipine being stopped in only one patient.This patient suffered a colonic bleed of moderate severity, which the investigator reported as possibly being associated with nimodipine.The patient required a blood transfusion but recovered uneventfully."Bleeding" events were reported as an adverse event in two further patients, both of whom had received nimodipine.The first patient was reported to have a rash and haematoma on the back, which the investigator stated was almost certainly related to the use of ceftazidine.The second patient was reported as having thrombocytopenia and anaemia.This was observed 15 days after the treatment with nimodipine was completed, and the investigator reported that these adverse events were possibly related to atenolol, which the patient was receiving at the time.Thus the data from the British aneurysm nimodipine trial give little support to the findings reported by Wagenknecht and colleagues, which are possibly artefacts, reflecting the authors' post hoc analyses.

As the centrepiece of Canberra, Lake Burley Griffin provides the setting for buildings of national importance and a venue for aquatic recreation while, as part of the Molonglo River, the lake has a role in the ecological processes of its broader setting. For the purposes of recreation and landscape a constant water level is preferred: the management plan requires the lake to be maintained at a prescribed normal level. In years of low rainfall this requirement could conflict with the water demands of other users. Episodes of high rainfall may also require compromise between competing objectives. For example, drawdown of lake levels for flood mitigation could impact on the lake's recreational and amenity values and the spill may not be a good use of water. Conditional Value at Risk, a risk measure developed by the financial industry for portfolio management, is defined as the expected loss given that some loss threshold is exceeded. Here, Conditional Value at Risk is applied as decision support for strategic planning and day-to-day operational problems in the hydraulic management of Lake Burley Griffin.

BACKGROUND: To investigate variation in rates of cataract surgery in New South Wales, Australia by area of residence for Aboriginal and non-Aboriginal adults. DESIGN: Observational data linkage study of hospital admissions. PARTICIPANTS: Two hundred eighty-nine thousand six hundred forty-six New South Wales residents aged 30 years and over admitted to New South Wales hospitals for 444,551 cataract surgery procedures between 2001 and 2008. METHODS: Analysis of linked routinely collected hospital data using direct standardization and multilevel negative binomial regression models accounting for clustering of individuals within Statistical Local Areas. MAIN OUTCOME MEASURES: Age-standardized cataract surgery rates and adjusted rate ratios. RESULTS: Aboriginal people had lower rates of cataract procedures than non-Aboriginal people of the same age and sex, living in the same Statistical Local Area (adjusted rate ratio 0.71, 95% confidence interval 0.68-0.75). There was significant variation in cataract surgery rates across Statistical Local Areas for both Aboriginal and non-Aboriginal people, with the disparity greater in major cities and less disadvantaged areas. Rates of surgery were lower for Aboriginal than non-Aboriginal people in most Statistical Local Areas, but in a few, the rates were similar or higher for Aboriginal people. CONCLUSIONS: Aboriginal people in New South Wales received less cataract surgery than non-Aboriginal people, despite evidence of higher cataract rates. This disparity was greatest in urban and wealthier areas. Higher rates of surgery for Aboriginal people observed in some specific locations are likely to reflect the availability of public ophthalmology services, targeted services for Aboriginal people and higher demand for surgery in these populations.

least, more than one symptom could be scored and perhaps more attention could be paid to the patients' experience of their illness,' including how they explain their illness and its course, what effect it has, how they feel about it, and what they expect of treatment (this is relatively easily done in an n of 1 trial).The n of 1 trial could indeed be used more in everyday clinical practice with good instruments, generic diaries, and a patient centred approach.

EDITOR,—In their response to a letter about their paper on hepatitis C in asymptomatic blood donors D …

Despite the success of efforts made to prevent the transmission of infections by blood transfusion, the risk of infectious donations entering the blood supply and transmitting infection to the recipients of blood components and blood products remains a concern. Following the implementation of donor selection and donation testing strategies to exclude HBV, HIV, and HCV infectious donations from the blood supply, direct observation of transmission of these viruses by blood transfusion has become rare and indirect estimation of the probable frequency of infectious donations entering the blood supply has become more common. Published estimates for different blood services and different periods of time have varied in their methods and scope. The limitations of the estimation process should be considered when using estimates of the risk of infectious donations entering the blood supply to address questions about blood safety.

Since its establishment on 1 July 2003, the National Blood Authority (NBA) has been making steady progress towards fulfilling its vision of ‘Saving and improving Australian lives through a world‐class blood supply’. While the NBA’s early focus has been on developing organisational infrastructure and meeting compliance requirements as a new Commonwealth agency, it has already begun to bring about improvements to the management of the blood sector in line with the recommendations of the 2001 Stephen Review. As the centralised procurement agency for blood and blood products, the NBA is responsible for managing existing supply contracts with the Australian Red Cross Blood Service, CSL Limited and a number of pharmaceutical companies, and is currently negotiating new contracts with two major suppliers. The NBA has also been working with the signatories to the National Blood Agreement, all nine Australian Government Jurisdictions, to coordinate national demand and supply planning. It is introducing an agreed single national pricing schedule and has developed improved forecasting models and reporting mechanisms to ensure that jurisdictional requirements for blood and blood products are more closely matched to supply. With time, the NBA hopes to play a greater facilitation role in encouraging the better clinical use of blood and blood products as this will not only result in better patient outcomes, but will also contribute to ensuring the adequacy of the blood supply. This presentation discusses why the NBA was established, its roles and responsibilities, and how it is working to bring about reforms in the sector in terms of increased value for money, transparency and accountability.

This chapter contains sections titled: Introduction The blood sector and context for hemovigilance programs in Australia Examples from Australian regional hemovigilance systems Australian national hemovigilance arrangements Data from other sources Communication/reporting Lessons learned from implementing hemovigilance in Australia Research opportunities in hemovigilance Conclusions/future directions Acknowledgments References

The National Blood Authority is standardising and strengthening access criteria for immunoglobulin (Ig) funded by all Australian governments under the national blood arrangements. The ‘Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia’ (the Criteria) was first published in 2007 and updated in 2012. After an independent review of the governance and access arrangements, the National Blood Authority (NBA) established a network of governance committees including specialist working groups (SWGs) and developed an online authorisation system (BloodSTAR). The Criteria currently included in BloodSTAR reflects the 2012 second edition of the Criteria. All states and territories, with the exception of NSW, now use BloodSTAR. The SWGs reviewed the evidence and made revisions for V3 of the Criteria. In 2015, public consultation was held on proposed V3 changes for conditions where Ig has an Established or Emerging Therapeutic Role. In 2017, public consultation was held on proposed V3 changes for conditions listed for Use in Exceptional Circumstances Only and for indications where Ig use is Not Supported. The V3 changes were endorsed by the National Immunoglobulin Governance Advisory Committee prior to presentation to the Jurisdictional Blood Committee for approval. The proposed changes, which aim to more clearly articulate and standardise the diagnostic, qualifying and review criteria, are required to assist with managing the growth in demand for this precious, human-derived product by ensuring it is only used for clinically appropriate purposes. The revised Criteria will ensure strengthened qualifying and review criteria, initial and continuing authorisation periods’, dosing controls and ensure the submission of supporting evidence. The V3 Criteria will undergo an extensive process to upload into BloodSTAR and transition existing patients to the new criteria.