Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

BACKGROUND: The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. OBJECTIVE: To describe the ethics/governance review pathway undertaken by AMOSS. METHOD: Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. RESULTS: Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. CONCLUSION: The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research.

Is in vitro fertilisation more effective than stimulated intrauterine insemination as a first-line therapy for subfertility? A cohort analysis.

OBJECTIVE: To compare a strategy of two cycles of intrauterine insemination with controlled ovarian hyperstimulation (IUI/COH) vs one in vitro fertilisation (IVF) treatment programme (one fresh plus associated frozen embryo cycles) in couples presenting with unexplained, mild male or mild female subfertility. METHODS: A retrospective cohort design was used and analysed according to intention-to-treat principles. A total of 272 couples underwent an intended course of two cycles of IUI/COH and 176 couples underwent one IVF treatment programme. RESULTS: The cumulative live birth rate (CLBR) per couple for the IUI/COH group was 27.6% compared to 39.2% for the IVF group (P = 0.01). The mean time to pregnancy was 69 days in the IUI/COH group compared to 44 days in the IVF group (P = 0.02). The IVF programme was costlier, with an incremental cost-effectiveness ratio for an additional live birth in the range of $39,637-$46,325. The multiple delivery rate was 13.3% in the IUI/COH group compared to 10.1% in the IVF group (P = 0.55). One set of triplets and one set of quadruplets followed IUI/COH treatment. CONCLUSIONS: One IVF treatment programme was more effective, but costlier than an intended course of two cycles of IUI/COH. With consistently higher success rates, shorter times to pregnancy and a trend to less higher order multiple pregnancies, this study supports the view that IVF is now potentially safer and more clinically effective than IUI/COH as a first-line therapy for subfertility.

Getting by on credit: how district health managers in Ghana cope with the untimely release of funds.

BACKGROUND: District health systems in Africa depend largely on public funding. In many countries, not only are these funds insufficient, but they are also released in an untimely fashion, thereby creating serious cash flow problems for district health managers. This paper examines how the untimely release of public sector health funds in Ghana affects district health activities and the way district managers cope with the situation. METHODS: A qualitative approach using semi-structured interviews was adopted. Two regions (Northern and Ashanti) covering the northern and southern sectors of Ghana were strategically selected. Sixteen managers (eight directors of health services and eight district health accountants) were interviewed between 2003/2004. Data generated were analysed for themes and patterns. RESULTS: The results showed that untimely release of funds disrupts the implementation of health activities and demoralises district health staff. However, based on their prior knowledge of when funds are likely to be released, district health managers adopt a range of informal mechanisms to cope with the situation. These include obtaining supplies on credit, borrowing cash internally, pre-purchasing materials, and conserving part of the fourth quarter donor-pooled funds for the first quarter of the next year. While these informal mechanisms have kept the district health system in Ghana running in the face of persistent delays in funding, some of them are open to abuse and could be a potential source of corruption in the health system. CONCLUSION: Official recognition of some of these informal managerial strategies will contribute to eliminating potential risks of corruption in the Ghanaian health system and also serve as an acknowledgement of the efforts being made by local managers to keep the district health system functioning in the face of budgetary constraints and funding delays. It may boost the confidence of the managers and even enhance service delivery.

Assisted reproductive technology treatment costs of a live birth: an age-stratified cost-outcome study of treatment in Australia.

OBJECTIVES: To calculate the cost of assisted reproductive technology (ART) treatment cycles and resultant live-birth events. DESIGN: Cost-outcome study based on a decision analysis model of significant clinical and economic outcomes of ART. SETTING AND PARTICIPANTS: All non-donor ART treatments initiated in Australia in 2002. Treatment cycles, maternal age and birth outcome data were obtained from the Australian and New Zealand Assisted Reproduction Database. Direct health care costs were obtained from fertility centres, and included government, private insurer and patient costs. MAIN OUTCOME MEASURES: Average health care cost of non-donor, fresh and frozen embryo ART treatment cycles. Average and age-specific costs per live-birth event following ART treatment. RESULTS: Average health care cost per non-donor ART live-birth event was 32,903 US dollars (range, 24,809 US dollars for women < 30 years to 97,884 US dollars for women > or = 40 years). The cost per live birth for women aged > or = 42 years was 182,794 US dollars. The average treatment cost of a fresh cycle was 6,940 US dollars, compared with 1,937 US dollars for a frozen embryo transfer cycle. CONCLUSIONS: Debate regarding funding for ART services has been hindered by a lack of economic studies of ART treatments and outcomes in Australia. This is the most comprehensive costing study of ART services to date in terms of resources consumed during ART treatment. It confirms that ART treatment is less cost-effective in older women. Alongside economic considerations of ART, community values, ethical judgements and clinical factors should influence policy decision-making.