My Baby's Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths.

OBJECTIVE: The My Baby's Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (the MBM intervention). DESIGN: Stepped-wedge cluster-randomised controlled trial. SETTING: Twenty-seven maternity hospitals in Australia and New Zealand. POPULATION: Women with a singleton pregnancy without major fetal anomaly at ≥28 weeks of gestation from August 2016 to May 2019. METHODS: The MBM intervention was implemented at randomly assigned time points, with the sequential introduction of eight groups of between three and five hospitals at 4-monthly intervals. Using generalised linear mixed models, the stillbirth rate was compared in the control and the intervention periods, adjusting for calendar time, study population characteristics and hospital effects. MAIN OUTCOME MEASURES: Stillbirth at ≥28 weeks of gestation. RESULTS: There were 304 850 births with 290 105 births meeting the inclusion criteria: 150 053 in the control and 140 052 in the intervention periods. The stillbirth rate was lower (although not statistically significantly so) during the intervention compared with the control period (2.2/1000 versus 2.4/1000 births; aOR 1.18, 95% CI 0.93-1.50; P = 0.18). The decrease in stillbirth rate was greater across calendar time: 2.7/1000 in the first versus 2.0/1000 in the last 18 months. No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. CONCLUSIONS: The MBM intervention did not reduce stillbirths beyond the downward trend over time. As a result of low uptake, the role of the intervention remains unclear, although the downward trend across time suggests some benefit in lowering the stillbirth rate. In this study setting, an awareness of the importance of fetal movements may have reached pregnant women and clinicians prior to the implementation of the intervention. TWEETABLE ABSTRACT: The My Baby's Movements intervention to raise awareness of decreased fetal movement did not significantly reduce stillbirth rates.

Australian women's perceptions and practice of sleep position in late pregnancy: An online survey.

BACKGROUND: Going-to-sleep in the supine position in later pregnancy (≥28 weeks) has been identified as a risk factor for stillbirth. Internationally, public awareness campaigns have been undertaken encouraging women to sleep on their side during late pregnancy. AIM: This study aimed to identify sleep practices, attitudes and knowledge in pregnant women, to inform an Australian safe sleeping campaign. METHODS: A web-based survey of pregnant women ≥28 weeks' gestation conducted from November 2017 to January 2018. The survey was adapted from international sleep surveys and disseminated via pregnancy websites and social media platforms. FINDINGS: Three hundred and fifty-two women participated. Five (1.6%) reported going to sleep in the supine position. Most (87.8%) had received information on the importance of side-sleeping in pregnancy. Information was received from a variety of sources including maternity care providers (186; 66.2%) and the internet (177; 63.0%). Women were more likely to report going to sleep on their side if they had received advice to do so (OR 2.3; 95% CI 1.0-5.1). Thirteen (10.8%) reported receiving unsafe advice, including changing their going-to-sleep position to the supine position. DISCUSSION: This indicates high level awareness and practice of safe late-pregnancy going-to-sleep position in participants. Opportunities remain for improvement in the information provided, and understanding needs of specific groups including Aboriginal and Torres Strait Islander women. CONCLUSION: Findings suggest Australian women understand the importance of sleeping position in late pregnancy. Inconsistencies in information provided remain and may be addressed through public awareness campaigns targeting women and their care providers.

Parent engagement in perinatal mortality reviews: an online survey of clinicians from six high-income countries.

OBJECTIVE: Parent engagement in perinatal mortality review meetings following stillbirth may benefit parents and improve patient safety. We investigated perinatal mortality review meeting practices, including the extent of parent engagement, based on self-reports from healthcare professionals from maternity care facilities in six high-income countries. DESIGN: Cross-sectional online survey. SETTING: Australia, Canada, Ireland, New Zealand, UK and USA. POPULATION: A total of 1104 healthcare professionals, comprising mainly obstetricians, gynaecologists, midwives and nurses. METHODS: Data were drawn from responses to a survey covering stillbirth-related topics. Open- and closed-items that focused on 'Data quality on causes of stillbirth' were analysed. MAIN OUTCOME MEASURES: Healthcare professionals' self-reported practices around perinatal mortality review meetings following stillbirth. RESULTS: Most clinicians (81.0%) were aware of regular audit meetings to review stillbirth at their maternity facility, although this was true for only 35.5% of US respondents. For the 854 respondents whose facility held regular meetings, less than a third (31.1%) reported some form of parent engagement, and this was usually in the form of one-way post-meeting feedback. Across all six countries, only 17.1% of respondents described an explicit approach where parents provided input, received feedback and were represented at meetings. CONCLUSIONS: We found no established practice of involving parents in the perinatal mortality review process in six high-income countries. Parent engagement may hold the key to important lessons for stillbirth prevention and care. Further understanding of approaches, barriers and enablers is warranted. TWEETABLE ABSTRACT: Parent engagement in mortality review after stillbirth is rare, based on data from six countries. We need to understand the barriers.

Implementation and evaluation of a quality improvement initiative to reduce late gestation stillbirths in Australia: Safer Baby Bundle study protocol.

BACKGROUND: In 2015, the stillbirth rate after 28 weeks (late gestation) in Australia was 35% higher than countries with the lowest rates globally. Reductions in late gestation stillbirth rates have steadily improved in Australia. However, to amplify and sustain reductions, more needs to be done to reduce practice variation and address sub-optimal care. Implementing bundles for maternity care improvement in the UK have been associated with a 20% reduction in stillbirth rates. A similar approach is underway in Australia; the Safer Baby Bundle (SBB) with five elements: 1) supporting women to stop smoking in pregnancy, 2) improving detection and management of fetal growth restriction, 3) raising awareness and improving care for women with decreased fetal movements, 4) improving awareness of maternal safe going-to-sleep position in late pregnancy, 5) improving decision making about the timing of birth for women with risk factors for stillbirth. METHODS: This is a mixed-methods study of maternity services across three Australian states; Queensland, Victoria and New South Wales. The study includes evaluation of 'targeted' implementer sites (combined total approximately 113,000 births annually, 50% of births in these states) and monitoring of key outcomes state-wide across all maternity services. Progressive implementation over 2.5 years, managed by state Departments of Health, commenced from mid-2019. This study will determine the impact of implementing the SBB on maternity services and perinatal outcomes, specifically for reducing late gestation stillbirth. Comprehensive process, impact, and outcome evaluations will be conducted using routinely collected perinatal data, pre- and post- implementation surveys, clinical audits, focus group discussions and interviews. Evaluations explore the views and experiences of clinicians embedding the SBB into routine practice as well as women's experience with care and the acceptability of the initiative. DISCUSSION: This protocol describes the evaluation of the SBB initiative and will provide evidence for the value of a systematic, but pragmatic, approach to strategies to reduce the evidence-practice gaps across maternity services. We hypothesise successful implementation and uptake across three Australian states (amplified nationally) will be effective in reducing late gestation stillbirths to that of the best performing countries globally, equating to at least 150 lives saved annually. TRIAL REGISTRATION: The Safer Baby Bundle Study was retrospectively registered on the ACTRN12619001777189 database, date assigned 16/12/2019.

Learning from regret.

BACKGROUND: Death after surgery is infrequent but can be devastating for the surgeon. Surgeons may experience intense emotional reactions after a patient's death, reflecting on their part in the death and the patient's loss of life. Excessive rumination or feelings of regret may have lasting negative consequences, but these reactions may also facilitate learning for future decision-making. This qualitative study analysed surgeons' reflections on what might have been done differently before a patient's death and explored non-technical (cognitive and interpersonal) aspects of care as potential targets for improvement. METHODS: In Australia's Queensland Audit of Surgical Mortality, surgeons reflect on factors surrounding the death of patients in their care and respond to the open-ended question: in retrospect, would you have done anything differently? Framework analysis was applied to surgeons' responses to identify themes relating to non-technical aspects of care. RESULTS: Responses from 1214 surgeons were analysed. Two main themes were identified. Dilemmas and difficult decisions confirmed the uncertainty, complexity and situational pressures that often precede a surgical death; regret and empathy for patients featured in some responses. In the second main theme, communication matters, surgeons cited better communication, with patients, families, colleagues and at handover, as a source of reflective change to improve decision-making and reduce regret. CONCLUSION: Surgical decision-making involves uncertainty, and regret may occur after a patient's death. Enhancing the quality of communication with patients and peers in comprehensive assessment of the surgical patient may mitigate postdecision regret among surgeons.

Survey of Australian maternity hospitals to inform development and implementation of a stillbirth prevention 'bundle of care'.

BACKGROUND: 'Bundles of care' are being implemented to improve key practice gaps in perinatal care. As part of our development of a stillbirth prevention bundle, we consulted with Australian maternity care providers. OBJECTIVE: To gain the insights of Australian maternity care providers to inform the development and implementation of a bundle of care for stillbirth prevention. METHODS: A 2018 on-line survey of hospitals providing maternity services included 55 questions incorporating multiple choice, Likert items and open text. A senior clinician at each site completed the survey. The survey asked questions about practices related to fetal growth restriction, decreased fetal movements, smoking cessation, intrapartum fetal monitoring, maternal sleep position and perinatal mortality audit. The objectives were to assess which elements of care were most valued; best practice frequency; and, barriers and enablers to implementation. RESULTS: 227 hospitals were invited with 83 (37%) responding. All proposed elements were perceived as important. Hospitals were least likely to follow best practice recommendations "all the time" for smoking cessation support (<50%), risk assessment for fetal growth restriction (<40%) and advice on sleep position (<20%). Time constraints, absence of clear guidelines and lack of continuity of carer were recognised as barriers to implementation across care practices. CONCLUSIONS: Areas for practice improvement were evident. All elements of care were valued, with increasing awareness of safe sleeping position perceived as less important. There is strong support from maternity care providers across Australia for a bundle of care to reduce stillbirth.

My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.

BACKGROUND: Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates. METHODS/DESIGN: This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models. DISCUSSION: Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app. TRIAL REGISTRATION: ACTRN12614000291684. Registered 19 March 2014. VERSION: Protocol Version 6.1, February 2018.

Care in subsequent pregnancies following stillbirth: an international survey of parents.

OBJECTIVE: To assess the frequency of additional care, and parents' perceptions of quality, respectful care, in pregnancies subsequent to stillbirth. DESIGN: Multi-language web-based survey. SETTING: International. POPULATION: A total of 2716 parents, from 40 high- and middle-income countries. METHODS: Data were obtained from a broader survey of parents' experiences following stillbirth. Data were analysed using descriptive statistics and stratified by geographic region. Subgroup analyses explored variation in additional care by gestational age at index stillbirth. MAIN OUTCOME MEASURES: Frequency of additional care, and perceptions of quality, respectful care. RESULTS: The majority (66%) of parents conceived their subsequent pregnancy within 1 year of stillbirth. Additional antenatal care visits and ultrasound scans were provided for 67% and 70% of all parents, respectively, although there was wide variation across geographic regions. Care addressing psychosocial needs was less frequently provided, such as additional visits to a bereavement counsellor (10%) and access to named care provider's phone number (27%). Compared with parents whose stillbirth occurred at ≤ 29 weeks of gestation, parents whose stillbirth occurred at ≥ 30 weeks of gestation were more likely to receive various forms of additional care, particularly the option for early delivery after 37 weeks. Around half (47-63%) of all parents felt that elements of quality, respectful care were consistently applied, such as spending enough time with parents and involving parents in decision-making. CONCLUSIONS: Greater attention is required to providing thoughtful, empathic and collaborative care in all pregnancies following stillbirth. Specific education and training for health professionals is needed. TWEETABLE ABSTRACT: More support for providing quality care in pregnancies after stillbirth is needed. PLAIN LANGUAGE SUMMARY: Study rationale and design More than two million babies are stillborn every year. Most parents will conceive again soon after having a stillborn baby. These parents are more likely to have another stillborn baby in the next pregnancy than parents who have not had a stillborn baby before. The next pregnancy after stillbirth is often an extremely anxious time for parents, as they worry about whether their baby will survive. In this study we asked 2716 parents from 40 countries about the care they received during their first pregnancy after stillbirth. Parents were recruited mainly through the International Stillbirth Alliance and completed on online survey that was available in six languages. Findings Parents often had extra antenatal visits and extra ultrasound scans in the next pregnancy, but they rarely had extra emotional support. Also, many parents felt their care providers did not always listen to them and spend enough time with them, involve them in decisions, and take their concerns seriously. Parents were more likely to receive various forms of extra care in the next pregnancy if their baby had died later in pregnancy compared to earlier in pregnancy. Limitations In this study we only have information from parents who were able and willing to complete an online survey. Most of the parents were involved in charity and support groups and most parents lived in developed countries. We do not know how well the findings relate to other parents. Finally, our study does not include parents who may have tried for another pregnancy but were not able to conceive. Potential impact This study can help to improve care through the development of best practice guidelines for pregnancies following stillbirth. The results suggest that parents need better emotional support in these pregnancies, and more opportunities to participate actively in decisions about care. Extra support should be available no matter how far along in pregnancy the previous stillborn baby died.

A survey of Australian and New Zealand clinical practice with neoadjuvant systemic therapy for breast cancer.

BACKGROUND: Neoadjuvant systemic therapy (NAST) has become an established treatment option for women with operable breast cancer. AIM: We aimed to better understand NAST treatment patterns, barriers and facilitators in Australia and New Zealand. METHODS: We undertook a cross-sectional survey of the current clinical practice of Australian and New Zealand breast cancer specialists. Questions included referral patterns for NAST, patient selection, logistics, decision making and barriers. RESULTS: Of 207 respondents, 162 (78%) reported routinely offering NAST to selected patients with operable breast cancer (median 9% of patients offered NAST). Specialty, location, practice type, gender or years of experience did not predict for offering NAST. In all, 45 and 58% wanted to increase the number of patients who receive NAST in routine care and in clinical trials respectively. Facilitators included the multidisciplinary team meeting and access to NAST clinical trials. Specialist-reported patient barriers included: patient desire for immediate surgery (63% rated as important/very important); lack of awareness of NAST (50%); concern about progression (43%) and disinterest in downstaging (32%). Forty-three per cent of participants experienced system-related barriers to the use of NAST, including other clinicians' lack of interest (27%); lack of clinical trials (24%) and unacceptable wait for a medical oncology appointment (37%). CONCLUSION: This group of Australian and New Zealand clinicians are interested in NAST for operable breast cancer in routine care and clinical trials. Patient- and system-related barriers that prevent the optimal uptake of this treatment approach will need to be systematically addressed if NAST is to become a more common approach.

Observation versus late reintroduction of letrozole as adjuvant endocrine therapy for hormone receptor-positive breast cancer (ANZ0501 LATER): an open-label randomised, controlled trial.

BACKGROUND: Despite the effectiveness of adjuvant endocrine therapy in preventing breast cancer recurrence, breast cancer events continue at a high rate for at least 10 years after completion of therapy. PATIENTS AND METHODS: This randomised open label phase III trial recruited postmenopausal women from 29 Australian and New Zealand sites, with hormone receptor-positive early breast cancer, who had completed ≥4 years of endocrine therapy [aromatase inhibitor (AI), tamoxifen, ovarian suppression, or sequential combination] ≥1 year prior, to oral letrozole 2.5 mg daily for 5 years, or observation. Treatment allocation was by central computerised randomisation, stratified by institution, axillary node status and prior endocrine therapy. The primary outcome was invasive breast cancer events (new invasive primary, local, regional or distant recurrence, or contralateral breast cancer), analysed by intention to treat. The secondary outcomes were disease-free survival (DFS), overall survival, and safety. RESULTS: Between 16 May 2007 and 14 March 2012, 181 patients were randomised to letrozole and 179 to observation (median age 64.3 years). Endocrine therapy was completed at a median of 2.6 years before randomisation, and 47.5% had tumours of >2 cm and/or node positive. At 3.9 years median follow-up (interquartile range 3.1-4.8), 2 patients assigned letrozole (1.1%) and 17 patients assigned observation (9.5%) had experienced an invasive breast cancer event (difference 8.4%, 95% confidence interval 3.8% to 13.0%, log-rank test P = 0.0004). Twenty-four patients (13.4%) in the observation and 14 (7.7%) in the letrozole arm experienced a DFS event (log-rank P = 0.067). Adverse events linked to oestrogen depletion, but not serious adverse events, were more common with letrozole. CONCLUSION: These results should be considered exploratory, but lend weight to emerging data supporting longer duration endocrine therapy for hormone receptor-positive breast cancer, and offer insight into reintroduction of AI therapy. CLINICAL TRIALS NUMBER: Australian New Zealand Clinical Trials Registry (www.anzctr.org.au), ACTRN12607000137493.

Stillbirth rates among Indigenous and non-Indigenous women in Queensland, Australia: is the gap closing?

OBJECTIVE: To determine whether the disparity gap is closing between stillbirth rates for Indigenous and non-Indigenous women and to identify focal areas for future prevention efforts according to gestational age and geographic location. DESIGN: Population-based retrospective cohort study. SETTING: Queensland, Australia. POPULATION: All singleton births of at least 20 weeks of gestation or at least 400 g birthweight. METHODS: Routinely collected data on births were obtained for the period 1995 to 2011. Indigenous and non-Indigenous stillbirth rates and percent reduction in the gap were compared over time and by geographic location and gestational age. MAIN OUTCOME MEASURES: All-cause and cause-specific stillbirth rates (per 1000 ongoing pregnancies). RESULTS: Over the study period there was a 57.3% reduction in the disparity gap. Although marked reductions in the gap were shown for women in regional (57.0%) and remote (56.1%) locations, these women remained at increased risk compared with those in urban regions. There was no reduction for term stillbirths. Major conditions contributing to the disparity were maternal conditions (diabetes) (relative risk [RR] 3.78, 95% confidence intervals [95% CI] 2.59-5.51), perinatal infection (RR 3.70, 95% CI 2.54-5.39), spontaneous preterm birth (RR 3.08, 95% CI 2.51-3.77), hypertension (RR 2.22, 95% CI 1.45-3.39), fetal growth restriction (RR 1.78, 95% CI 1.17-2.71) and antepartum haemorrhage (RR 1.58, 95% CI 1.13-2.22). CONCLUSIONS: The gap in stillbirth rates between Indigenous and non-Indigenous women is closing, but Indigenous women continue to be at increased risk due to a number of potentially preventable conditions. There is little change in the gap at term gestational ages.

Survivorship care plans in cancer: a systematic review of care plan outcomes.

BACKGROUND: Eight years after the Institute of Medicine recommended survivorship care plans (SCPs) for all cancer survivors, this study systematically reviewed the evidence for their use. METHODS: Studies evaluating outcomes after implementation of SCPs for cancer survivors were identified by searching databases (MEDLINE, EMBASE and Cochrane). Data were extracted and summarised. RESULTS: Ten prospective studies (2286 survivors) met inclusion criteria (5 randomised controlled trials (RCTs)). Study populations included survivors of breast, gynaecological, colorectal and childhood cancer. Several models of SCP were evaluated (paper based/on-line, oncologist/nurse/primary-care physician-delivered and different templates). No significant effect of SCPs was found on survivor distress, satisfaction with care, cancer-care coordination or oncological outcomes in RCTs. Breast cancer survivors with SCPs were better able to correctly identify the clinician responsible for their follow-up care. One study suggested a positive impact on reducing unmet needs. Levels of survivor satisfaction with, and self-reported understanding of, their SCP were very high. Feasibility was raised by health professionals as a significant barrier, as SCPs took 1-4 h of their time to develop. CONCLUSIONS: Emerging evidence shows very few measurable benefits of SCPs. Survivors reported high levels of satisfaction with SCPs. Resource issues were identified as a significant barrier to implementation.

Tissue biomarkers of breast cancer and their association with conventional pathologic features.

BACKGROUND: Tissue protein expression profiling has the potential to detect new biomarkers to improve breast cancer (BC) diagnosis, staging, and prognostication. This study aimed to identify tissue proteins that differentiate breast cancer tissue from healthy breast tissue using protein chip mass spectrometry and to examine associations with conventional pathological features. METHODS: To develop a training model, 82 BC and 82 adjacent unaffected tissue (AT) samples were analysed on cation-exchange protein chips by time-of-flight mass spectrometry. For validation, 89 independent BC and AT sample pairs were analysed. RESULTS: From the protein peaks that were differentially expressed between BC and AT by univariate analysis, binary logistic regression yielded two peaks that together classified BC and AT with a ROC area under the curve of 0.92. Two proteins, ubiquitin and S100P (in a novel truncated form), were identified by liquid chromatography/tandem mass spectrometry and validated by immunoblotting and reactive-surface protein chip immunocapture. The combined marker panel was positively associated with high histologic grade, larger tumour size, lymphovascular invasion, ER and PR positivity, and HER2 overexpression, suggesting that it may be associated with a HER2-enriched molecular subtype of breast cancer. CONCLUSION: This independently validated protein panel may be valuable in the classification and prognostication of breast cancer patients.

General practitioners' views on perceived and actual gains, benefits and barriers associated with the implementation of an Australian health assessment for people with intellectual disability.

BACKGROUND: Health assessments for people with intellectual disability have been implemented in the UK, New Zealand and Australia, and have led to improved health outcomes. The Comprehensive Health Assessment Program (CHAP) has been shown to improve the health of people with intellectual disability. Similar to other health assessments, it is designed to address healthcare needs, many of which are often overlooked in this population, through better communication between the general practitioner (GP), support worker and the person with intellectual disability. This study investigates GP views of the perceived and actual benefits, gains and barriers associated with its uptake and use in practice. METHOD: As part of a larger randomised controlled trial of the CHAP, 46 GPs in Queensland, Australia, completed two telephone interviews that included open-ended questions about their perceptions of the health assessment. The GPs were enrolled in the intervention arm of the trial. Interviews took place at commencement and conclusion of the trial to gain the views of GPs as they experienced using the CHAP. Thematic analysis was used to identify key themes and patterns from the GP responses. RESULTS: Four themes were identified: better healthcare and uncertain benefits captured GP perceptions of the potential gains associated with use of the CHAP, while two further themes, organisational barriers in the general practice setting and engagement across the healthcare triad highlighted strengths and barriers related to implementation. Anticipated concerns about time raised by GPs at commencement of the trial were borne out in practice, but concerns about communication and cooperation of people with disabilities were not. Matters associated with support worker engagement emerged as an area of concern. CONCLUSIONS: GPs perceive the CHAP as a structured and comprehensive approach to the detection of medical problems as well as an aid in overcoming communication barriers between the doctor and the person with disability. Our findings suggest that some GPs may find it difficult to predict the benefits of using health assessments such as the CHAP. Achieving optimal uptake is likely to require attention at policy and systems levels to address: GP time constraints in providing healthcare to this population; enhancement of support worker training and organisational structures to encourage comprehensive health assessment and follow-up activities; and GP awareness of the improved health outcomes shown to derive from the use of comprehensive health assessments.

Health advocacy: a vital step in attaining human rights for adults with intellectual disability.

BACKGROUND: People with intellectual disability (ID) experience health inequity compared with the general population, a key contributing factor being disparities in social determinants of health. The enactment of the United Nations Convention on the Rights of Persons with Disabilities (CRPD) provides a platform for the progression and promotion of health and other interconnected rights to address barriers to the highest attainable standard of health for this populace. Rights can be brought to life through advocacy efforts. This paper explores the meaning, perceptions and experiences of advocacy by family members and paid support workers of adults with ID and locates the findings within a health and human rights discourse. METHODS: As part of a larger randomised controlled trial, 113 parents and 84 support workers of adults with ID completed a telephone interview that included open-ended questions about their understanding and experiences of advocacy. Thematic analysis was used to identify relevant themes. RESULTS: Five key themes were identified. The first underscored how advocacy to 'speak up' for the person with ID is integral to both parent and support worker roles. The second and third themes considered the contexts for advocacy efforts. Access to quality health care was a core concern, along with advocacy across other areas and sectors to address the person's wider psychosocial needs. The remaining themes highlighted the many dimensions to advocacy, including differences between parent and support worker views, with parental advocacy being an expression of 'caring' and support workers motivated by a 'duty of care' to protect the individual's 'rights'. CONCLUSION: Parent and support worker advocacy provides one means to address the social determinants of health and fulfilment of health rights of and for people with ID. Policy and practice in the context of governmental obligation under the CRPD should support advocacy and make health rights the reality not rhetoric for this group of men and women.

Health and demographic characteristics of respondents in an Australian national sexuality survey: comparison with population norms.

STUDY OBJECTIVE: To assess the representativeness of survey participants by systematically comparing volunteers in a national health and sexuality survey with the Australian population in terms of self reported health status (including the SF-36) and a wide range of demographic characteristics. DESIGN: A cross sectional sample of Australian residents were compared with demographic data from the 1996 Australian census and health data from the 1995 National Health Survey. SETTING: The Australian population. PARTICIPANTS: A stratified random sample of adults aged 18-59 years drawn from the Australian electoral roll, a compulsory register of voters. Interviews were completed with 1784 people, representing 40% of those initially selected (58% of those for whom a valid telephone number could be located). MAIN RESULTS: Participants were of similar age and sex to the national population. Consistent with prior research, respondents had higher socioeconomic status, more education, were more likely to be employed, and less likely to be immigrants. The prevalence estimates, means, and variances of self reported mental and physical health measures (for example, SF-36 subscales, women's health indicators, current smoking status) were similar to population norms. CONCLUSIONS: These findings considerably strengthen inferences about the representativeness of data on health status from volunteer samples used in health and sexuality surveys.

Couple distress after sudden infant or perinatal death: a 30-month follow up.

OBJECTIVE: To examine, using a 30-month prospective study, patterns of anxiety, depression and alcohol use in couples following stillbirth, neonatal death or sudden infant death syndrome. METHODOLOGY: One hundred and thirty-eight bereaved and 156 non-bereaved couples completed standardized interviews at 2, 8, 15 and 30 months post-loss. RESULTS: At all interviews, bereaved couples were significantly more likely than non-bereaved couples to have at least one distressed partner. Rarely were both partners distressed in either group. For bereaved couples, 'mother only' distress declined from 21% to 10% during the study. 'Father only' distress ranged from 7% to 15%, peaking at 30 months. Bereaved mothers who were distressed at 2 months reported significantly lower marital satisfaction at 30 months. CONCLUSIONS: At the couple level, the experience of a baby's death is multifaceted. Gender differences are common and partners' needs may change over time. Early recognition of these differences may facilitate longer-term adjustment for both partners.

The experimental neuroprotectant leukaemia inhibitory factor (LIF) does not compromise antitumour activity of paclitaxel, cisplatin and carboplatin.

PURPOSE: Peripheral neuropathy caused by the anticancer agents cisplatin and paclitaxel is a significant dose-limiting toxicity of these drugs. The growth factor leukaemia inhibitory factor (LIF) has neuroprotectant activity in preclinical models of nerve injury and degeneration and is now in a phase II trial in chemotherapy-induced peripheral neuropathy (CIPN). It is therefore important to ensure that LIF neither inhibits the antitumour activity of these drugs, nor stimulates tumour growth. METHODS: Mature female Dark Agouti rats were implanted subcutaneously with a mammary carcinoma, DAMA. It was confirmed that the tumour expressed LIF receptors by reverse transcriptase polymerase chain reaction. Paclitaxel was administered at a dose of 5 mg/kg daily for 6 days, cisplatin at a dose of 3 mg/kg twice weekly and carboplatin at a dose of 10 mg/kg twice weekly. The effect of LIF on tumour growth and response to chemotherapy was assessed at two doses (2 and 10 microg/kg per day). Peripheral neuropathy was assessed in terms of gait disturbance and tail-flick threshold. RESULTS: Neither dose of LIF stimulated growth of control tumours. Mean tumour volumes were lower on day 14 in all paclitaxel-, cisplatin- and carboplatin-treated groups, compared to controls (ANOVA P<0.001). LIF did not interfere with this antitumour effect. Cisplatin- and paclitaxel-treated groups had developed increasing tail-flick thresholds by day 14. These manifestations of sensory neuropathy were prevented by LIF administration. CONCLUSIONS: These results suggest that LIF may be safely used in human trials as a neuroprotectant for patients receiving cisplatin, paclitaxel and carboplatin without concern for impairment of antitumour effect.

Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme.

Treatment options and prognosis remains poor for patients with recurrent glioblastoma multiforme. These tumors are highly vascularised and over express angiogenic factors such as vascular endothelial growth factor and may potentially be responsive to antiangiogenic therapies. We present the results of a phase II trial of Thalidomide, an antiangiogenic agent, in the treatment of recurrent glioblastoma multiforme. Patients were treated with 100 mg/day of Thalidomide, increased at weekly intervals by 100 mg to a maximum tolerated dose of 500 mg/d. Forty-two patients were enrolled, with 38 patients being assessable for response and 39 for toxicity. Two patients (5%) achieved a partial response and 16 (42%) had stable disease. The median survival was 31 weeks and the 1-year survival was 35%. Patients who had a partial response or stable disease had either a stabilisation or improvement in quality of life scores or performance status. Overall Thalidomide was well tolerated with no grade 4 toxicities and no treatment related deaths. The median maximum tolerated dose was 300 mg/day. The most common toxicity was fatigue to which patients developed tachyphylaxis. There was no correlation demonstrated with plasma vascular endothelial growth factor levels and response or survival. Thalidomide is a well-tolerated drug that may have some activity in the treatment of recurrent glioblastoma. Optimum dosing with antiangiogenic agents is currently under investigation. Chronic low dose therapy may be required to see conventional responses or improvements in time to progression. The dose required to achieve optimal biological impact may be better defined once we have established reliable surrogate endpoints.