Endometrial and vaginal effects of low-dose estradiol delivered by vaginal ring or vaginal tablet

Aims The major aims of the study were to compare the safety of a continuous low-dose estradiol-releasing vaginal ring (ESTring) to that of a vaginal estradiol tablet (Vagifem®) on the endometrium and the relief of subjective symptoms and signs of urogenital estrogen deficiency. Quality of life and acceptability of treatment delivery were also assessed. Study design A prospective, randomized study in which women were assigned in a 2: 1 ratio to ESTring and Vagifem and followed for 12 months. The primary endpoint was endometrial safety, based on the results of ultrasound measurement of endometrial thickness and a progestogen challenge test at baseline and week 48. Efficacy was determined by subjective assessment of urogenital estrogen deficiency symptoms at baseline and weeks 3, 12, 24, 36 and 48 and assessment of signs of vaginal epithelial atrophy by the clinician at baseline, 12 and 48 weeks. In addition, pelvic floor strength, vaginal cytological evaluation and pH, bacteruria and patient acceptability were assessed. Quality of life was assessed using a menopause-specific quality-of-life questionnire and a 2-day bladder diary at baseline and 12 and 48 weeks. The comparability of the two groups was assessed using ANOVA, χ(2) or Fisher's exact tests. Results A total of 126 women were randomized to ESTring and 59 to Vagifem. There was no statistical difference between the groups in the alleviation of symptoms and signs of urogenital estrogen deficiency. Maturation indices increased in both groups, from generally atrophic at baseline to proliferative or highly proliferative at 48 weeks. After 48 weeks of treatment, there was no statistically significant difference in endometrial thickness between the two groups. A statistically smaller proportion of bleeding/spotting occurred in the ESTring group (n = 0) compared to the Vagifem users (n = 4). Estradiol and total estrone serum levels increased during treatment in both groups but remained within the normal postmenopausal range. General health status in both groups was unchanged but the urogenital component of health burden was significantly improved in both groups. Bladder diary variables showed no differences between treatment groups. Conclusion Equivalent endometrial safety and efficacy in the relief of the symptoms and signs of urogenital estrogen deficiency were demonstrated for the 12 months' use of a low-dose estradiol-releasing vaginal ring and a vaginal estradiol tablet.

Assessing cost-effectiveness in mental health: vocational rehabilitation for schizophrenia and related conditions

Objective: Existing evidence suggests that vocational rehabilitation services, in particular individual placement and support (IPS), are effective in assisting people with schizophrenia and related conditions gain open employment. Despite this, such services are not available to all unemployed people with schizophrenia who wish to work. Existing evidence suggests that while IPS confers no clinical advantages over routine care, it does improve the proportion of people returning to employment. The objective of the current study is to investigate the net benefit of introducing IPS services into current mental health services in Australia. Method: The net benefit of IPS is assessed from a health sector perspective using cost-benefit analysis. A two-stage approach is taken to the assessment of benefit. The first stage involves a quantitative analysis of the net benefit, defined as the benefits of IPS (comprising transfer payments averted, income tax accrued and individual income earned) minus the costs. The second stage involves application of 'second-filter' criteria (including equity, strength of evidence, feasibility and acceptability to stakeholders) to results. The robustness of results is tested using the multivariate probabilistic sensitivity analysis. Results: The costs of IPS are $A10.3M (95% uncertainty interval $A7.4M-$A13.6M), the benefits are $A4.7M ($A3.1M-$A6.5M), resulting in a negative net benefit of $A5.6M ($A8.4M-$A3.4M). Conclusions: The current analysis suggests that IPS costs are greater than the monetary benefits. However, the evidence-base of the current analysis is weak. Structural conditions surrounding welfare payments in Australia create disincentives to full-time employment for people with disabilities.

User dyads in software testing: bypassing the need for expert observers

This paper arises out of a research study into the online help facilities provided in popular software applications such as word processors. Its particular focus is on experimental methods of evaluating the effectiveness and usability of those facilities. Focus groups, questionnaires, and online surveys had already been used in other phases of the study, but it was judged that these approaches would be unsuitable for measuring effectiveness and usability because they are susceptible to respondents' subjectivity. Direct observation of people working on set word-processing tasks was ruled out initially because of a lack of trained observers; it would have taken too long for the investigator to observe a large enough sample by himself. Automatic recording of users' actions was also rejected, as it would have demanded equipment and/or software that was not available and seemed too expensive to acquire. The approach and techniques described here were an attempt to overcome these difficulties by using observers drawn from the same population of students that provided the test subjects; as a by-product, this may also have enhanced the acceptability (and hence possibly the validity) of the experiments by reducing the exam pressure perceived by participants.

Assessing cost-effectiveness of drug interventions for schizophrenia

Objective: To assess from a health sector perspective the incremental cost-effectiveness of eight drug treatment scenarios for established schizophrenia. Method: Using a standardized methodology, costs and outcomes are modelled over the lifetime of prevalent cases of schizophrenia in Australia in 2000. A two-stage approach to assessment of health benefit is used. The first stage involves a quantitative analysis based on disability-adjusted life years (DALYs) averted, using best available evidence. The robustness of results is tested using probabilistic uncertainty analysis. The second stage involves application of 'second filter' criteria (equity, strength of evidence, feasibility and acceptability) to allow broader concepts of benefit to be considered. Results: Replacing oral typicals with risperidone or olanzapine has an incremental cost-effectiveness ratio (ICER) of A$48 000 and A$92 000/DALY respectively. Switching from low-dose typicals to risperidone has an ICER of A$80 000. Giving risperidone to people experiencing side-effects on typicals is more cost-effective at A$20 000. Giving clozapine to people taking typicals, with the worst course of the disorder and either little or clear deterioration, is cost-effective at A$42 000 or A$23 000/DALY respectively. The least cost-effective intervention is to replace risperidone with olanzapine at A$160 000/DALY. Conclusions: Based on an A$50 000/DALY threshold, low-dose typical neuroleptics are indicated as the treatment of choice for established schizophrenia, with risperidone being reserved for those experiencing moderate to severe side-effects on typicals. The more expensive olanzapine should only be prescribed when risperidone is not clinically indicated. The high cost of risperidone and olanzapine relative to modest health gains underlie this conclusion. Earlier introduction of clozapine however, would be cost-effective. This work is limited by weaknesses in trials (lack of long-term efficacy data, quality of life and consumer satisfaction evidence) and the translation of effect size into a DALY change. Some stakeholders, including SANE Australia, argue the modest health gains reported in the literature do not adequately reflect perceptions by patients, clinicians and carers, of improved quality of life with these atypicals.

General practitioner, specialist providers case conferences in palliative care: Lessons learned from 56 case conferences

OBJECTIVE: To describe the utility and acceptability to general practitioners and palliative care staff of case conferences in palliative care. METHOD: Research focussed on case conferences conducted between GPs and staff of three specialist palliative care units (in an inner urban, outer metropolitan and regional setting), at the time of referral of patients to the service. Telephone interviews were conducted with all GPs who participated in a case conference, and focus groups were conducted with palliative care staff. RESULTS: For most GPs, case conferences by teleconference were a time effective and immediate means of information transfer. The best instances for a conference were at time of patient referral, time of discharge to the community, or where the case was complex. General practitioners appreciated access to multiple professionals simultaneously. Workload pressures were a drawback of participation for both GPs and specialists. Palliative care team members thought case conferences gave GPs an appreciation of a team approach, and reduced professional isolation. The usefulness of the case conferences depended on the willingness of the GP to participate. General practitioners would participate again provided they did not have to organise the case conference. Specialist staff were concerned by the financial cost of organising case conferences. DISCUSSION: Case conferences provide useful information exchange between GPs and specialist staff, and are acceptable to both parties. Much depends on the individual GPs attitude toward participation, as well as the timing of the conferences in the course of the patient's illness. Organisation needs to be a task of the specialist units, who would need administrative support to organise them. (author abstract)

Fracture load and marginal fit of shrinkage-free ZrSiO4 all-ceramic crowns after chewing simulation

The aim of this in vitro study was to evaluate the fracture load and marginal accuracy of crowns made from a shrinkage-free ZrSiO4 ceramic cemented with glass-ionomer or composite cement after chewing simulation. Thirty-two human mandibular molars were randomly divided into two groups. All teeth were prepared for and restored with shrinkage-free ZrSiO4 ceramic crowns (Everest HPC (R), KaVo). The crowns of group A (N = 16) were luted to the teeth using KetacCem (R) and group B (N = 16) were adhesively cemented using Panavia (R) 21EX. Measurements of the marginal accuracy before and after cementation were made using replicas and an image analysis system. All specimens were exposed to 1.2 million cycles of thermo-mechanical fatigue in a chewing simulator. Surviving specimens were subsequently loaded until fracture in a static testing device. Fracture loads (N) were recorded. All specimens survived chewing simulation. The mean fracture loads (+/- s.d.) were Group A, 1622 N (+/- 433); group B, 1957 N (+/- 806). There was no significant difference between the two groups (P > 0.05). The marginal gap values before cementation were (mean +/- s.d.): Group A, 32.7 mu m (+/- 6.8); group B, 33.0 mu m (+/- 6.7).The mean marginal gap values after cementation were (+/- s.d.): Group A, 44.6 mu m (+/- 6.7); group B, 46.6 mu m (+/- 7.7). The marginal openings were significantly higher after cementation for both groups (P < 0.05). All test groups demonstrated fracture load and marginal accuracy values within the range of clinical acceptability.

Vaccine components and constituents: Responding to consumer concerns

Vaccination remains a vital strategy in the prevention of infectious disease. Commercial vaccine formulations contain a range of additives or manufacturing residuals, which may contribute to patient concerns about vaccine safety. Primary health care professionals are well placed to address patient concerns about vaccine safety. We describe the key constituents present in vaccines, discuss issues related to safety and acceptability of these constituents, and provide a table highlighting constituents of commercially available vaccines in Australia.

Carotenoid content of pandanus fruit cultivars and other foods of the Republic of Kiribati

Background: Kiribati, a remote atoll island country of the Pacific, has serious problems of vitamin A deficiency (VAD). Thus, it is important to identify locally grown acceptable foods that might be promoted to alleviate this problem. Pandanus fruit (Pandanus tectorius) is a well-liked indigenous Kiribati food with many cultivars that have orange/yellow flesh, indicative of carotenoid content. Few have been previously analysed. Aim: This study was conducted to identify cultivars of pandanus and other foods that could be promoted to alleviate VAD in Kiribati. Method: Ethnography was used to select foods and assess acceptability factors. Pandanus and other foods were analysed for beta- and alpha-carotene, beta-cryptoxanthin, lutein, zeaxanthin, lycopene and total carotenoids using high-performance liquid chromatography. Results: Of the nine pandanus cultivars investigated there was a great range of provitamin A carotenoid levels (from 62 to 19 086 mu g beta-carotene/100 g), generally with higher levels in those more deeply coloured. Seven pandanus cultivars, one giant swamp taro (Cyrtosperma chamissonis) cultivar and native fig (Ficus tinctoria) had significant provitamin A carotenoid content, meeting all or half of estimated daily vitamin A requirements within normal consumption patterns. Analyses in different laboratories confirmed high carotenoid levels in pandanus but showed that there are still questions as to how high the levels might be, owing to variation arising from different handling/preparation/analytical techniques. Conclusions: These carotenoid-rich acceptable foods should be promoted for alleviating VAD in Kiribati and possibly other Pacific contexts where these foods are important. Further research in the Pacific is needed to identify additional indigenous foods with potential health benefits.

Validation of multicriteria analysis models

Validation procedures play an important role in establishing the credibility of models, improving their relevance and acceptability. This article reviews the testing of models relevant to environmental and natural resource management with particular emphasis on models used in multicriteria analysis (MCA). Validation efforts for a model used in a MCA catchment management study in North Queensland, Australia, are presented. Determination of face validity is found to be a useful approach in evaluating this model, and sensitivity analysis is useful in checking the stability of the model. (C) 2000 Elsevier Science Ltd. All rights reserved.