160 results on '"Boyle FM"'
Search Results
2. My Baby's Movements: A Stepped-Wedge Cluster-Randomised Controlled Trial of a Fetal Movement Awareness Intervention to Reduce Stillbirths
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Flenady, V, Gardener, G, Ellwood, D, Coory, M, Weller, M, Warrilow, KA, Middleton, PF, Wojcieszek, AM, Groom, KM, Boyle, FM, East, C, Lawford, H, Callander, E, Said, JM, Walker, SP, Mahomed, K, Andrews, C, Gordon, A, Norman, JE, and Crowther, C
- Subjects
Adult ,Pregnancy Trimester, Third ,Australia ,Obstetrics and Gynecology ,Prenatal Care ,General Medicine ,Patient Acceptance of Health Care ,Stillbirth ,Young Adult ,Pregnancy ,Humans ,1114 Paediatrics and Reproductive Medicine ,Female ,Pregnant Women ,Obstetrics & Reproductive Medicine ,Fetal Movement ,11 Medical and Health Sciences ,New Zealand - Abstract
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.
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- 2022
3. Sexual dysfunction in the Australian population
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Boyle, FM, Cook, MD, Purdie, DM, Najman, JM, and Dunne, MP
- Published
- 2003
4. Stillbirth in Australia 5: Making respectful care after stillbirth a reality: The quest for parent-centred care
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Boyle FM, Horey D, Dean JH, Loughnan S, Ludski K, Mead J, Homer CS, de Wilde D, Morris J, and Flenady VJ
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Obstetrics & Reproductive Medicine ,11 Medical and Health Sciences - Abstract
© 2020 Australian College of Midwives Stillbirth is a tragedy that can leave parents feeling powerless and vulnerable. Respectful and supportive bereavement care is essential to reducing adverse psychosocial impact. Initiatives of the Australian Centre of Research Excellence in Stillbirth are designed to improve care after stillbirth. At their heart are the voices of perinatally bereaved parents and support organisations and shared decision making between parents and health care providers. Priorities in future perinatal bereavement care research include ensuring appropriate care for population groups who experience higher rates of stillbirth and addressing implementation challenges to best practice in respectful and supportive bereavement care within our health systems.
- Published
- 2020
5. Stillbirth in Australia 1: The road to now: Two decades of stillbirth research and advocacy in Australia
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Flenady VJ, Middleton P, Wallace E, Morris J, Gordon A, Boyle FM, Homer C, Henry S, Brezler L, Wojcieszek AM, Davies-Tuck M, Coory M, Callander E, Kumar S, Clifton V, Leisher SH, Blencowe H, Forbes M, Sexton J, and Ellwood D
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population characteristics ,Obstetrics & Reproductive Medicine ,female genital diseases and pregnancy complications ,reproductive and urinary physiology ,11 Medical and Health Sciences - Abstract
© 2020 Australian College of Midwives Stillbirth is a major public health problem with an enormous mortality burden and psychosocial impact on parents, families and the wider community both globally and in Australia. In 2015, Australia's late gestation stillbirth rate was over 30% higher than that of the best-performing countries globally, highlighting the urgent need for action. We present an overview of the foundations which led to the establishment of Australia's NHMRC Centre of Research Excellence in Stillbirth (Stillbirth CRE) in 2017 and highlight key activities in the following areas: Opportunities to expand and improve collaborations between research teams; Supporting the conduct and development of innovative, high quality, collaborative research that incorporates a strong parent voice; Promoting effective translation of research into health policy and/or practice; and the Regional and global work of the Stillbirth CRE. We highlight the first-ever Senate Inquiry into Stillbirth in Australia in 2018. These events ultimately led to the development of a National Stillbirth Action and Implementation Plan for Australia with the aims of reducing stillbirth rates by 20% over the next five years, reducing the disparity in stillbirth rates between advantaged and disadvantaged communities, and improving care for all families who experience this loss.
- Published
- 2020
6. Parent engagement in perinatal mortality reviews: an online survey of clinicians from six high‐income countries.
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Boyle, FM, Horey, D, Siassakos, D, Burden, C, Bakhbakhi, D, Silver, RM, and Flenady, V
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PERINATAL death , *MEDICAL personnel , *HIGH-income countries , *INTERNET surveys , *PARENTS - Abstract
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. Parent engagement in mortality review after stillbirth is rare, based on data from six countries. We need to understand the barriers. Parent engagement in mortality review after stillbirth is rare, based on data from six countries. We need to understand the barriers. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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7. Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance)
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Unger, JM, Phillips, K-A, Boyle, FM, Hitre, E, Porter, DJ, Francis, PA, Minasian, LM, Gelber, RD, Goldstein, LJ, Gomez, HL, Vallejos, C, Partridge, AH, Dakhil, SR, Martino, S, Barlow, WE, Fabian, CJ, Meyskens, FL, Hortobagyi, GN, and Albain, KS
- Abstract
LBA505 Background: Premature ovarian failure (POF) is a common toxicity of CT. Risk depends on type and amount of CT, age, and perhaps ovarian cycling at the time of CT. POEMS is a SWOG-coordinated phase III randomized study to evaluate whether LHRH analog administration with CT for early-stage breast cancer (BC) would reduce POF.Premenopausal patients (PT) age .05). POF rates were 22% in the standard arm and 8% in the GN arm (OR=0.30, 95% CI: 0.10-0.87, p=.03 [unadjusted analysis]; OR=0.36, 95%CI: 0.11-1.14, p=0.08 [adjusted logistic regression analysis]). In a sensitivity analysis defining 2-year POF more liberally as either amenorrhea or elevated FSH, 45% in the standard arm and 20% in the GN arm had POF (OR=0.29, 95% CI: 0.12-0.70, p=.006). There were 13 pregnancies in the standard arm and 22 in the GN arm (OR=2.22, 95% CI: 1.00-4.92, p=.05). DFS and OS were better in the GN arm (Cox regression, including stage: HR=0.49, 95% CI: 0.24-0.97, p=.04; HR=0.43, 95% CI: 0.18-1.00, p=.05, respectively).LHRH analog administration with CT was associated with less POF and more pregnancies. In an exploratory analysis, GN use in premenopausal ER-negative BC was associated with improved DFS and OS.NCT00068601.
- Published
- 2014
8. Stillbirth rates among Indigenous and non-Indigenous women in Queensland, Australia: is the gap closing?
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Ibiebele, I, Coory, M, Boyle, FM, Humphrey, M, Vlack, S, and Flenady, V
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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. [ABSTRACT FROM AUTHOR]- Published
- 2015
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9. Follow up after breast cancer - views of Australian women.
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Brennan M, Butow P, Spillane AJ, Marven M, and Boyle FM
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- 2011
10. Health and demographic characteristics of respondents in an Australian national sexuality survey: comparison with population norms.
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Purdie DM, Dunne MP, Boyle FM, Cook MD, and Najman JM
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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. [ABSTRACT FROM AUTHOR]
- Published
- 2002
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11. Couple distress after sudden infant or perinatal death: a 30-month follow up.
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Vance, JC, Boyle, FM, Najman, JM, Thearle, MJ, Vance, J C, Boyle, F M, Najman, J M, and Thearle, M J
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SUDDEN infant death syndrome , *PERINATAL death - Abstract
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. [ABSTRACT FROM AUTHOR]- Published
- 2002
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12. Psychological changes in parents eight months after the loss of an infant from stillbirth, neonatal death, or sudden infant death syndrome -- a longitudinal study.
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Vance JC, Najman JM, Thearle MJ, Embelton G, Foster WJ, and Boyle FM
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- 1995
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13. Towards respectful supportive care after stillbirth for every woman.
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Flenady, V and Boyle, FM
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STILLBIRTH , *MEDICAL personnel , *COMMUNITY health workers - Abstract
Stillbirth is a persistent public health problem with enormous impacts on parents, families and communities (de Bernis et al. I Lancet i 2016;387:703-16). The care of health workers and community is vital to parents' recovery after stillbirth (Flenady et al. I BJOG i 2014;121:137-40). Health workers confronted with such losses need training, support and culturally specific and context-specific care guidelines. [Extracted from the article]
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- 2021
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14. Risks associated with low functional health literacy in Australian population. Comment.
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Bush RA, Boyle FM, Ostini R, Bush, Robert A, Boyle, Frances M, and Ostini, Remo
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- 2010
15. Experiences of antenatal care practices to reduce stillbirth: surveys of women and healthcare professionals pre-post implementation of the Safer Baby Bundle.
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Andrews C, Boyle FM, Pade A, Middleton P, Ellwood D, Gordon A, Davies-Tuck M, Homer C, Griffin A, Nicholl M, Sketcher-Baker K, and Flenady V
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- Humans, Female, Pregnancy, Adult, Australia, Surveys and Questionnaires, Fetal Growth Retardation prevention & control, Health Knowledge, Attitudes, Practice, Health Personnel, Fetal Movement, Patient Care Bundles, Stillbirth epidemiology, Prenatal Care methods, Smoking Cessation methods
- Abstract
Background: The Safer Baby Bundle (SBB) aimed to reduce stillbirth rates in Australia through improving pregnancy care across five elements; smoking cessation, fetal growth restriction (FGR), decreased fetal movements (DFM), side sleeping in late pregnancy and decision making around timing of birth. We assessed experiences of women and healthcare professionals (HCPs) with antenatal care practices around the five elements., Methods: A pre-post study design using online surveys was employed to assess change in HCPs awareness, knowledge, and frequency of performing recommended practices (22 in total) and women's experiences of care received related to reducing their chance of stillbirth. Women who had received antenatal care and HCPs (midwives and doctors) at services participating in the SBB implementation program in two Australian states were invited to participate. Surveys were distributed over January to July 2020 (pre) and August to December 2022 (post). Comparison of pre-post responses was undertaken using Fisher's exact, Pearson's chi-squared or Wilcoxon rank-sum tests., Results: 1,225 women (pre-1096/post-129) and 1,415 HCPs (pre-1148/post-267, ≥ 83% midwives) completed the surveys. The frequency of HCPs performing best practice 'all the time' significantly improved post-SBB implementation across all elements including providing advice to women on side sleeping (20.4-79.4%, p < 0.001) and benefits of smoking cessation (54.5-74.5%, p < 0.001), provision of DFM brochure (43.2-85.1%, p < 0.001), risk assessments for FGR (59.2-84.1%, p < 0.001) and stillbirth (44.5-73.2%, p < 0.001). Practices around smoking cessation in general showed less improvement e.g. using the 'Ask, Advise and Help' brief advice model at each visit (15.6-20.3%, p = 0.088). Post-implementation more women recalled conversations about stillbirth and risk reduction (32.2-50.4%, p < 0.001) and most HCPs reported including these conversations in their routine care (35.1-83.0%, p < 0.001). Most HCPs agreed that the SBB had become part of their routine practice (85.0%)., Conclusions: Implementation of the SBB was associated with improvements in practice across all targeted elements of care in stillbirth prevention including conversations with women around stillbirth risk reduction. Further consideration is needed around strategies to increase uptake of practices that were more resistant to change such as smoking cessation support., Trial Registration: The Safer Baby Bundle Study was retrospectively registered on the Australian New Zealand Clinical Trials Registry database, ACTRN12619001777189, date assigned 16/12/2019., (© 2024. The Author(s).)
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- 2024
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16. Looking after bubba for all our mob: Aboriginal and Torres Strait Islander community experiences and perceptions of stillbirth.
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Massi L, Lewis C, Stewart S, Jans D, Gautam R, Jalloub L, Bowman A, Middleton P, Vlack S, Boyle FM, Shepherd C, Flenady V, Stuart-Butler D, and Rae KM
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- Adult, Female, Humans, Male, Pregnancy, Australia, Australian Aboriginal and Torres Strait Islander Peoples, Interviews as Topic, Focus Groups, Qualitative Research, Stillbirth psychology
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The stillbirth rate among Aboriginal and Torres Strait Islander women and communities in Australia is around double that of non-Indigenous women. While the development of effective prevention strategies during pregnancy and improving care following stillbirth for women and families in communities has become a national priority, there has been limited progress in stillbirth disparities. With community permission, this study aimed to gain a better understanding of community experiences, perceptions, and priorities around stillbirth. We undertook an Indigenous researcher-led, qualitative study, with community consultations guided by a cultural protection protocol and within an unstructured research framework. A total of 18 communities were consulted face-to-face through yarning interviews, focus groups and workshops. This included 54 community member and 159 health professional participants across remote, regional, and urban areas of Queensland, Western Australia, Victoria, South Australia, and Northern Territory. Thematic analysis of consultation data identified common themes across five focus/priority areas to address stillbirth: Stillbirth or Sorry Business Baby care needs to be family-centered; using Indigenous "ways of knowing, being, and doing" to ensure cultural safety; application of Birthing on Country principles to maternal and perinatal care; and yarning approaches to improve communication and learning or education. The results underscore the critical need to co-design evidence-based, culturally appropriate, and community-acceptable resources to help reduce existing disparities in stillbirth rates., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Massi, Lewis, Stewart, Jans, Gautam, Jalloub, Bowman, Middleton, Vlack, Boyle, Shepherd, Flenady, Stuart-Butler and Rae.)
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- 2024
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17. Adverse childhood experiences, the risk of pregnancy complications and adverse pregnancy outcomes: a systematic review and meta-analysis.
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Mamun A, Biswas T, Scott J, Sly PD, McIntyre HD, Thorpe K, Boyle FM, Dekker MN, Doi S, Mitchell M, McNeil K, Kothari A, Hardiman L, and Callaway LK
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- Infant, Newborn, Child, Pregnancy, Female, Humans, Pregnancy Outcome epidemiology, Adverse Childhood Experiences, Pregnancy Complications epidemiology, Pregnancy Complications diagnosis, Diabetes, Gestational epidemiology, Premature Birth epidemiology
- Abstract
Background: Adverse childhood experiences (ACEs) have a profound negative impact on health. However, the strength of the association between ACEs and pregnancy complications and adverse pregnancy outcomes is not well quantified or understood., Objective: To conduct a systematic review and meta-analysis of the association between ACEs and risk of pregnancy complications and adverse pregnancy outcomes., Search Strategy: A comprehensive search was conducted using PubMed, Embase, CINAHL, PsycINFO, ClinicalTrials.gov and Google scholar up to July 2022., Data Collection and Analysis: Two reviewers independently conducted the screening and quality appraisal using a validated tool. Meta-analysis using the quality-effects model on the reported odds ratio (OR) was conducted. Heterogeneity and inconsistency were examined using the I
2 statistics., Results: 32 studies from 1508 met a priori inclusion criteria for systematic review, with 21 included in the meta-analysis. Pooled analyses showed that exposure to ACEs increased the risk of pregnancy complications (OR 1.37, 95% CI 1.20 to 1.57) and adverse pregnancy outcomes (OR 1.31, 95% CI 1.17 to 1.47). In sub-group analysis, maternal ACEs were associated with gestational diabetes mellitus (OR 1.39, 95% CI 1.11 to 1.74), antenatal depression (OR 1.59, 95% CI 1.15 to 2.20), low offspring birth weight (OR 1.27, 95% CI 1.02 to 1.47), and preterm delivery (OR 1.41, 95% CI 1.16 to 1.71)., Conclusion: The results suggest that exposure to ACEs increases the risk of pregnancy complications and adverse pregnancy outcomes. Preventive strategies, screening and trauma-informed care need to be examined to improve maternal and child health., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2023
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18. Validation of a tool for determining the clinical utility of stillbirth investigations.
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Marsden T, Khong TY, Dahlstrom JE, Ellwood D, Moghimi A, Prystupa S, O'brien C, Cassam F, Martin S, Coory M, Boyle FM, and Flenady V
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- Female, Pregnancy, Humans, Stillbirth, Placenta, Cause of Death, Pregnancy Complications, Placenta Diseases
- Abstract
Background: Up to 20% of all stillbirths and 45% of term stillbirths are currently classified as unexplained. Many of these stillbirths do not undergo currently recommended investigations. This may leave questions unanswered and not identify stillbirths with a recurrence risk in subsequent pregnancies., Aims: To validate a new tool (Stillbirth Investigation Utility Tool) to identify the clinical utility of investigations in stillbirth and the inter-rater agreement on cause of stillbirth using the Perinatal Society of Australia and New Zealand-Perinatal Death Classification (PSANZ-PDC)., Materials and Methods: Thirty-four stillbirths were randomly selected for inclusion, each assessed independently by five blinded assessors. The investigations were grouped into three categories: clinical and laboratory; placental pathology; and autopsy examination. The cause of death was assigned at the end of each group. Outcome measures were clinical utility of investigations measured by assessor rated usefulness and inter-rater agreement on the assigned cause of death., Results: Comprehensive maternal history, maternal full blood count, maternal blood group and screen and placenta histopathology were useful in all cases. Clinical photographs were not performed and should have been performed in 50% of cases. The inter-rater agreement on cause of death assigned after all investigation results was 0.93 (95% CI 0.87-1.0)., Conclusions: The new Stillbirth Investigation Utility Tool showed very good agreement in assigning the cause of death using PSANZ-PDC. Four investigations were useful in all cases. Minor refinements will be made based on feedback to enhance usability for wider implementation in research studies to assess the yield of investigations in stillbirths., (© 2023 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)
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- 2023
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19. My Baby's Movements: An assessment of the effectiveness of the My Baby's Movements phone program in reducing late-gestation stillbirth rates.
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Skalecki S, Lawford H, Gardener G, Coory M, Bradford B, Warrilow K, Wojcieszek AM, Newth T, Weller M, Said JM, Boyle FM, East C, Gordon A, Middleton P, Ellwood D, and Flenady V
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- Infant, Pregnancy, Female, Infant, Newborn, Humans, Parity, Pregnancy Rate, Fetal Movement, Stillbirth epidemiology, Premature Birth
- Abstract
Background: Delayed reporting of decreased fetal movements (DFM) could represent a missed opportunity to prevent stillbirth. Mobile phone applications (apps) have the potential to improve maternal awareness and reporting of DFM and contribute to stillbirth prevention., Aims: To evaluate the effectiveness of the My Baby's Movements (MBM) app on late-gestation stillbirth rates., Materials and Methods: The MBM trial evaluated a multifaceted fetal movements awareness package across 26 maternity services in Australia and New Zealand between 2016 and 2019. In this secondary analysis, generalised linear mixed models were used to compare rates of late-gestation stillbirth, obstetric interventions, and neonatal outcomes between app users and non-app users including calendar time, cluster, primiparity and other potential confounders as fixed effects, and hospital as a random effect., Results: Of 140 052 women included, app users comprised 9.8% (n = 13 780). The stillbirth rate was not significantly lower among app users (1.67/1000 vs 2.29/1000) (adjusted odds ratio (aOR) 0.79; 95% CI 0.51-1.23). App users were less likely to have a preterm birth (aOR 0.81; 0.75-0.88) or a composite adverse neonatal outcome (aOR 0.87; 0.81-0.93); however, they had higher rates of induction of labour (IOL) (aOR 1.27; 1.22-1.32) and early term birth (aOR 1.08; 1.04-1.12)., Conclusions: The MBM app had low uptake and its use was not associated with stillbirth rates but was associated with some neonatal benefit, and higher rates of IOL and early term birth. Use and acceptability of tools designed to promote fetal movement awareness is an important knowledge gap. The implications of increased IOL and early term births warrant consideration in future studies., (© 2023 Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)
- Published
- 2023
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20. Attitudes of Australian breast cancer patients toward the secondary use of administrative and clinical trial data.
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Hutchings E, Butcher BE, Butow P, and Boyle FM
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- Humans, Female, Australia epidemiology, Attitude, Surveys and Questionnaires, Breast Neoplasms drug therapy
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Aim: Little is known about the attitudes of Australian patients with a history of breast cancer toward the reuse of administrative health data and clinical trial data. Issues of consent, privacy, and information security are key to the discussion. Cancer care and research provides an opportune setting to develop an understanding of attitudes toward data sharing and reuse in individuals with a history of breast cancer., Methods: An anonymous, online questionnaire for individuals with a history or diagnosis of breast cancer was distributed by two peak bodies (Breast Cancer Trials [BCT] and Breast Cancer Network of Australia [BCNA]) to their memberships between July 14, 2020 and October 17, 2020. Results were captured in RedCap; data analysis was undertaken using Stata, and a thematic analysis of free text responses was undertaken using NVivo., Results: One hundred and thirty-two complete responses were received. Twenty-three percent of respondents had participated in a clinical trial, and 12% were currently receiving treatment (chemotherapy, radiotherapy, surgery, or endocrine). Respondents were supportive of the secondary use of de-identified administrative health data and clinical trial data, but showed concern about data security and privacy. Respondents emphasized that the reuse of data should be for improved societal health outcomes, not profit. Many assumed secondary analysis was already undertaken on de-identified administrative health data and clinical trial data., Conclusions: Respondents were supportive of the secondary use of de-identified administrative health and clinal trial data within the established bounds of good clinical practice and ethical oversight., (© 2022 John Wiley & Sons Australia, Ltd.)
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- 2023
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21. Multicountry study protocol of COCOON: COntinuing Care in COVID-19 Outbreak global survey of New, expectant, and bereaved parent experiences.
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Loughnan SA, Gautam R, Silverio SA, Boyle FM, Cassidy J, Ellwood D, Homer C, Horey D, Leisher SH, de Montigny F, Murphy M, O'Donoghue K, Quigley P, Ravaldi C, Sandall J, Storey C, Vannacci A, Wilson AN, and Flenady V
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- Infant, Newborn, Female, Humans, Pregnancy, Cross-Sectional Studies, Pandemics, Parents psychology, COVID-19, Maternal Health Services
- Abstract
Introduction: Globally, the COVID-19 pandemic has significantly disrupted the provision of healthcare and efficiency of healthcare systems and is likely to have profound implications for pregnant and postpartum women and their families including those who experience the tragedy of stillbirth or neonatal death. This study aims to understand the psychosocial impact of COVID-19 and the experiences of parents who have accessed maternity, neonatal and bereavement care services during this time., Methods and Analysis: An international, cross-sectional, online and/or telephone-based/face-to-face survey is being administered across 15 countries and available in 11 languages. New, expectant and bereaved parents during the COVID-19 pandemic will be recruited. Validated psychometric scales will be used to measure psychosocial well-being. Data will be analysed descriptively and by assessing multivariable associations of the outcomes with explanatory factors. In seven of these countries, bereaved parents will be recruited to a nested, qualitative interview study. The data will be analysed using a grounded theory analysis (for each country) and thematic framework analysis (for intercountry comparison) to gain further insights into their experiences., Ethics and Dissemination: Ethics approval for the multicountry online survey, COCOON, has been granted by the Mater Misericordiae Human Research Ethics Committee in Australia (reference number: AM/MML/63526). Ethics approval for the nested qualitative interview study, PUDDLES, has been granted by the King's College London Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee (reference number: HR-19/20-19455) in the UK. Local ethics committee approvals were granted in participating countries where required. Results of the study will be published in international peer-reviewed journals and through parent support organisations. Findings will contribute to our understanding of delivering maternity care services, particularly bereavement care, in high-income, lower middle-income and low-income countries during this or future health crises., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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22. Is care of stillborn babies and their parents respectful? Results from an international online survey.
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Atkins B, Blencowe H, Boyle FM, Sacks E, Horey D, and Flenady V
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- Cross-Sectional Studies, Female, Humans, Infant, Pregnancy, Respect, Surveys and Questionnaires, Parents, Stillbirth
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Objective: To quantify parents' experiences of respectful care around stillbirth globally., Design: Multi-country, online, cross-sectional survey., Setting and Population: Self-identified bereaved parents (n = 3769) of stillborn babies from 44 high- and middle-income countries., Methods: Parents' perspectives of seven aspects of care quality, factors associated with respectful care and seven bereavement care practices were compared across geographical regions using descriptive statistics. Respectful care was compared between country-income groups using multivariable logistic regression., Main Outcome Measures: Self-reported experience of care around the time of stillbirth., Results: A quarter (25.4%) of 3769 respondents reported disrespectful care after stillbirth and 23.5% reported disrespectful care of their baby. Gestation less than 30 weeks and primiparity were associated with disrespect. Reported respectful care was lower in middle-income countries than in high-income countries (adjusted odds ratio 0.35, 95% CI 0.29-0.42, p < 0.01). In many countries, aspects of care quality need improvement, such as ensuring families have enough time with providers. Participating respondents from Latin America and southern Europe reported lower satisfaction across all aspects of care quality compared with northern Europe. Unmet need for memory-making activities in middle-income countries was high., Conclusions: Many parents experience disrespectful care around stillbirth. Provider training and system-level support to address practical barriers are urgently needed. However, some practices (which are important to parents) can be readily implemented such as memory-making activities and referring to the baby by name., Tweetable Abstract: One in four experience disrespectful care after stillbirth. Parents want more time with providers and their babies, to talk and memory-make., (© 2022 John Wiley & Sons Ltd.)
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- 2022
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23. Living with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death.
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Loughnan SA, Boyle FM, Ellwood D, Crocker S, Lancaster A, Astell C, Dean J, Horey D, Callander E, Jackson C, Shand A, and Flenady V
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- Australia, Female, Grief, Humans, Infant, Newborn, Internet, Male, Parents psychology, Pregnancy, Quality of Life, Randomized Controlled Trials as Topic, Stillbirth psychology, Bereavement, Perinatal Death prevention & control
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Background: Stillbirth and neonatal death are devastating pregnancy outcomes with long-lasting psychosocial consequences for parents and families, and wide-ranging economic impacts on health systems and society. It is essential that parents and families have access to appropriate support, yet services are often limited. Internet-based programs may provide another option of psychosocial support for parents following the death of a baby. We aim to evaluate the efficacy and acceptability of a self-guided internet-based perinatal bereavement support program "Living with Loss" (LWL) in reducing psychological distress and improving the wellbeing of parents following stillbirth or neonatal death., Methods: This trial is a two-arm parallel group randomized controlled trial comparing the intervention arm (LWL) with a care as usual control arm (CAU). We anticipate recruiting 150 women and men across Australia who have experienced a stillbirth or neonatal death in the past 2 years. Participants randomized to the LWL group will receive the six-module internet-based program over 8 weeks including automated email notifications and reminders. Baseline, post-intervention, and 3-month follow-up assessments will be conducted to assess primary and secondary outcomes for both arms. The primary outcome will be the change in Kessler Psychological Distress Scale (K10) scores from baseline to 3-month follow-up. Secondary outcomes include perinatal grief, anxiety, depression, quality of life, program satisfaction and acceptability, and cost-effectiveness. Analysis will use intention-to-treat linear mixed models to examine psychological distress symptom scores at 3-month follow-up. Subgroup analyses by severity of symptoms at baseline will be undertaken., Discussion: The LWL program aims to provide an evidence-based accessible and flexible support option for bereaved parents following stillbirth or neonatal death. This may be particularly useful for parents and healthcare professionals residing in rural regions where services and supports are limited. This RCT seeks to provide evidence of the efficacy, acceptability, and cost-effectiveness of the LWL program and contribute to our understanding of the role digital services may play in addressing the gap in the availability of specific bereavement support resources for parents following the death of a baby, particularly for men., Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12621000631808 . Registered prospectively on 27 May 2021., (© 2022. The Author(s).)
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- 2022
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24. Australian women's perceptions and practice of sleep position in late pregnancy: An online survey.
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Warrilow KA, Gordon A, Andrews CJ, Boyle FM, Wojcieszek AM, Stuart Butler D, Ellwood D, Middleton PF, Cronin R, and Flenady VJ
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- Australia, Female, Humans, Pregnancy, Sleep, Stillbirth, Supine Position, Maternal Health Services
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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., (Copyright © 2021 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)
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- 2022
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25. Perinatal bereavement care during COVID-19 in Australian maternity settings.
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Boyle FM, Horey D, Dean JH, Lohan A, Middleton P, and Flenady V
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- Australia epidemiology, Child, Female, Humans, Infant, Newborn, Pandemics, Parents, Perinatal Care, Pregnancy, Stillbirth epidemiology, COVID-19 epidemiology, Hospice Care, Perinatal Death prevention & control
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Objectives: Perinatal bereavement care is a complex area of practice. The COVID-19 pandemic led to reconfiguration of maternity and perinatal bereavement care services. This study explores Australian health care providers' perspectives of the impact of COVID-19 on the provision of respectful and supportive care following stillbirth or neonatal death., Methods: Members of a perinatal bereavement care network were consulted at the commencement of the pandemic in Australia using an online feedback form. Respondents provided ratings and free-text comments on the impact of COVID-19 on implementation of 49 recommendations contained in the Perinatal Society of Australia and New Zealand/Stillbirth Centre of Research Clinical Practice Guideline for Respectful and Supportive Perinatal Bereavement Care ., Results: Responses were received from 35 health care providers who provided perinatal bereavement care in clinical settings or through support organisations in Australia. Major impacts of COVID-19 were reported for 8 of 49 guideline recommendations. Impacts included reduced: support for mothers due to visitor restrictions; availability of cultural and spiritual support and interpreters; involvement of support people in decision-making; options for memory-making and commemorative rituals; and staff training and supervision. Adaptations to minimise impacts included virtual consultations, online staff training, use of cold cots, and increased staff support for memory-making., Conclusions: Health care providers encounter substantial challenges as they strive to implement best practice perinatal bereavement care in pandemic conditions. Some practice adaptations developed during the COVID-19 pandemic could benefit parents; however, evaluation of their effectiveness and acceptability is needed., (© 2022 Frances M. Boyle et al., published by De Gruyter, Berlin/Boston.)
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- 2022
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26. Effect of Cancer Pain Guideline Implementation on Pain Outcomes Among Adult Outpatients With Cancer-Related Pain: A Stepped Wedge Cluster Randomized Trial.
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Lovell MR, Phillips JL, Luckett T, Lam L, Boyle FM, Davidson PM, Cheah SL, McCaffrey N, Currow DC, Shaw T, Hosie A, Koczwara B, Clarke S, Lee J, Stockler MR, Sheehan C, Spruijt O, Allsopp K, Clinch A, Clark K, Read A, and Agar M
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- Aged, Australia, Female, Humans, Male, Middle Aged, Neoplasms complications, Treatment Outcome, Ambulatory Care, Cancer Pain diagnosis, Cancer Pain epidemiology, Cancer Pain therapy, Pain Management methods, Pain Management statistics & numerical data
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Importance: An evidence-practice gap exists for cancer pain management, and cancer pain remains prevalent and disabling., Objectives: To evaluate the capacity of 3 cancer pain guideline implementation strategies to improve pain-related outcomes for patients attending oncology and palliative care outpatient services., Design, Setting, and Participants: A pragmatic, stepped wedge, cluster-randomized, nonblinded, clinical trial was conducted between 2014 and 2019. The clusters were cancer centers in Australia providing oncology and palliative care outpatient clinics. Participants included a consecutive cohort of adult outpatients with advanced cancer and a worst pain severity score of 2 or more out of 10 on a numeric rating scale (NRS). Data were collected between August 2015 and May 2019. Data were analyzed July to October 2019 and reanalyzed November to December 2021., Interventions: Guideline implementation strategies at the cluster, health professional, and patient levels introduced with the support of a clinical champion., Main Outcomes and Measures: The primary measure of effect was the percentage of participants initially screened as having moderate to severe worst pain (NRS ≥ 5) who experienced a clinically important improvement of 30% or more 1 week later. Secondary outcomes included mean average pain, patient empowerment, fidelity to the intervention, and quality of life and were measured in all participants with a pain score of 2 or more 10 at weeks 1, 2, and 4., Results: Of 8099 patients screened at 6 clusters, 1564 were eligible, and 359 were recruited during the control phase (mean [SD] age, 64.2 [12.1] years; 196 men [55%]) and 329 during the intervention phase (mean [SD] age, 63.6 [12.7] years; 155 men [47%]), with no significant differences between phases on baseline measures. The mean (SD) baseline worst pain scores were 5.0 (2.6) and 4.9 (2.6) for control and intervention phases, respectively. The mean (SD) baseline average pain scores were 3.5 (2.1) for both groups. For the primary outcome, the proportions of participants with a 30% or greater reduction in a pain score of 5 or more of 10 at baseline were similar in the control and intervention phases (31 of 280 participants [11.9%] vs 30 of 264 participants [11.8%]; OR, 1.12; 95% CI, 0.79-1.60; P = .51). No significant differences were found in secondary outcomes between phases. Fidelity to the intervention was low., Conclusions and Relevance: A suite of implementation strategies was insufficient to improve pain-related outcomes for outpatients with cancer-related pain. Further evaluation is needed to determine the required clinical resources needed to enable wide-scale uptake of the fundamental elements of cancer pain care. Ongoing quality improvement activities should be supported to improve sustainability.
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- 2022
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27. My Baby's Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths.
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Flenady V, Gardener G, Ellwood D, Coory M, Weller M, Warrilow KA, Middleton PF, Wojcieszek AM, Groom KM, Boyle FM, East C, Lawford H, Callander E, Said JM, Walker SP, Mahomed K, Andrews C, Gordon A, Norman JE, and Crowther C
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- Adult, Australia epidemiology, Female, Humans, New Zealand epidemiology, Pregnancy, Pregnancy Trimester, Third, Young Adult, Fetal Movement, Patient Acceptance of Health Care, Pregnant Women, Prenatal Care, Stillbirth epidemiology
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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., (© 2021 John Wiley & Sons Ltd.)
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- 2022
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28. Parents' experiences of care offered after stillbirth: An international online survey of high and middle-income countries.
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Horey D, Boyle FM, Cassidy J, Cassidy PR, Erwich JJHM, Gold KJ, Gross MM, Heazell AEP, Leisher SH, Murphy M, Ravaldi C, Siassakos D, Storey C, Vannacci A, Wojcieszek A, and Flenady V
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- Developing Countries, Female, Humans, Parents, Pregnancy, Surveys and Questionnaires, Bereavement, Stillbirth epidemiology
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Background: Stillbirth, the death of a baby before birth, is associated with significant psychological and social consequences that can be mitigated by respectful and supportive bereavement care. The absence of high-level evidence to support the broad scope of perinatal bereavement practices means that offering a range of options identified as valued by parents has become an important indicator of care quality. This study aimed to describe bereavement care practices offered to parents across different high-income and middle-income countries., Methods: An online survey of parents of stillborn babies was conducted between December 2014 and February 2015. Frequencies of nine practices were compared between high-income and middle-income countries. Differences in proportions of reported practices and their associated odds ratios were calculated to compare high-income and middle-income countries., Results: Over three thousand parents (3041) with a self-reported stillbirth in the preceding five years from 40 countries responded. Fifteen countries had atleast 40 responses. Significant differences in the prevalence of offering nine bereavement care practices were reported by women in high-income countries (HICs) compared with women in middle-income countries (MICs). All nine practices were reported to occur significantly more frequently by women in HICs, including opportunity to see and hold their baby (OR = 4.8, 95% CI 4.0-5.9). The widespread occurrence of all nine practices was reported only for The Netherlands., Conclusions: Bereavement care after stillbirth varies between countries. Future research should look at why these differences occur, their impact on parents, and whether differences should be addressed, particularly how to support effective communication, decision-making, and follow-up care., (© 2021 Wiley Periodicals LLC.)
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- 2021
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29. Building a sustainable rural physician workforce.
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Ostini R, McGrail MR, Kondalsamy-Chennakesavan S, Hill P, O'Sullivan B, Selvey LA, Eley DS, Adegbija O, Boyle FM, Dettrick Z, Jennaway M, and Strasser S
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- Australia, Career Choice, Education, Medical, Continuing, General Practitioners supply & distribution, Humans, Leadership, Medical Staff, Hospital supply & distribution, Medicine, Pediatricians supply & distribution, Referral and Consultation, Physicians supply & distribution, Rural Health Services, Workforce
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CHAPTER 1: CHARACTERISING AUSTRALIA'S RURAL SPECIALIST PHYSICIAN WORKFORCE: THE PROFESSIONAL PROFILE AND PROFESSIONAL SATISFACTION OF JUNIOR DOCTORS AND CONSULTANTS: Objective: To assess differences in the demographic characteristics, professional profile and professional satisfaction of rural and metropolitan junior physicians and physician consultants in Australia., Design, Setting and Participants: Cross-sectional, population level national survey of the Medicine in Australia: Balancing Employment and Life longitudinal cohort study (collected 2008-2016). Participants were specialist physicians from four career stage groups: pre-registrars (physician intent); registrars; new consultants (< 5 years since Fellowship); and consultants., Main Outcome Measures: Level of professional satisfaction across various job aspects, such as hours worked, working conditions, support networks and educational opportunities, comparing rural and metropolitan based physicians., Results: Participants included 1587 pre-registrars (15% rural), 1745 physician registrars (9% rural), 421 new consultants (20% rural) and 1143 consultants (13% rural). Rural physicians of all career stages demonstrated equivalent professional satisfaction across most job aspects, compared with metropolitan physician counterparts. Some examples of differences in satisfaction included rural pre-registrars being less likely to agree they had good access to support and supervision from qualified consultants (odds ratio [OR], 0.6; 95% CI, 0.3-0.9) and rural consultants being more likely to agree they had a poorer professional support network (OR, 1.9; 95% CI, 1.2-2.9). In terms of demographics, relatively more rural physicians had a rural background or were trained overseas. Although most junior physicians were women, female consultants were less likely to be working in a rural location (OR, 0.6; 95% CI, 0.4-0.8)., Conclusion: Junior physicians in metropolitan or rural settings have a similar professional experience, which is important in attracting future trainees. Increased opportunities for rural training should be prioritised, along with addressing concerns about the professional isolation and poorer support network of those in rural areas, not only among junior doctors but also consultants. Finally, making rural practice more attractive to female junior physicians could greatly improve the consultant physician distribution. CHAPTER 2: GENERAL PHYSICIANS AND PAEDIATRICIANS IN RURAL AUSTRALIA: THE SOCIAL CONSTRUCTION OF PROFESSIONAL IDENTITY: Objective: To explore the construction of professional identity among general physicians and paediatricians working in non-metropolitan areas., Design, Setting and Participants: In-depth qualitative interviews were conducted with general physicians and paediatricians, plus informants from specialist colleges, government agencies and academia who were involved in policy and programs for the training and recruitment of specialists in rural locations across three states and two territories. This research is part of the Training Pathways and Professional Support for Building a Rural Physician Workforce Study, 2018-19., Main Outcome Measures: Individual and collective descriptors of professional identity., Results: We interviewed 36 key informants. Professional identity for general physicians and paediatricians working in regional, rural and remote Australia is grounded in the breadth of their training, but qualified by location - geographic location, population served or specific location, where social and cultural context specifically shapes practice. General physicians and paediatricians were deeply engaged with their local community and its economic vulnerability, and they described the population size and dynamics of local economies as determinants of viable practice. They often complemented their practice with formal or informal training in areas of special interest, but balanced their practice against subspecialist availability, also dependent on demographics. While valuing their professional roles, they showed limited inclination for industrial organisation., Conclusion: Despite limited consensus on identity descriptors, rural general physicians and paediatricians highly value generalism and their rural engagement. The structural and geographic bias that preferences urban areas will need to be addressed to further develop coordinated strategies for advanced training in rural contexts, for which collective identity is integral. CHAPTER 3: SUSTAINABLE RURAL PHYSICIAN TRAINING: LEADERSHIP IN A FRAGILE ENVIRONMENT: Objectives: To understand Royal Australasian College of Physicians (RACP) training contexts, including supervisor and trainee perspectives, and to identify contributors to the sustainability of training sites, including training quality., Design, Setting and Participants: A cross-sectional mixed-methods design was used. A national sample of RACP trainees and Fellows completed online surveys. Survey respondents who indicated willingness to participate in interviews were purposively recruited to cover perspectives from a range of geographic, demographic and training context parameters., Main Outcome Measures: Fellows' and trainees' work and life satisfaction, and their experiences of supervision and training, respectively, by geographic location., Results: Fellows and trainees reported high levels of satisfaction, with one exception - inner regional Fellows reported lower satisfaction regarding opportunities to use their abilities. Not having a good support network was associated with lower satisfaction. Our qualitative findings indicate that a culture of undermining rural practice is prevalent and that good leadership at all levels is important to reduce negative impacts on supervisor and trainee availability, site accreditation and viability. Trainees described challenges in navigating training pathways, ensuring career development, and having the flexibility to meet family needs. The small number of Fellows in some sites poses challenges for supervisors and trainees and results in a blurring of roles; accreditation is an obstacle to provision of training at rural sites; and the overlap between service and training roles can be difficult for supervisors., Conclusion: Our qualitative findings emphasise the distinctive nature of regional specialist training, which can make it a fragile environment. Leadership at all levels is critical to sustaining accreditation and support for supervisors and trainees. CHAPTER 4: PRINCIPLES TO GUIDE TRAINING AND PROFESSIONAL SUPPORT FOR A SUSTAINABLE RURAL SPECIALIST PHYSICIAN WORKFORCE: Objective: To draw on research conducted in the Building a Rural Physician Workforce project, the first national study on rural specialist physicians, to define a set of principles applicable to guiding training and professional support action., Design: We used elements of the Delphi approach for systematic data collection and codesign, and applied a hybrid participatory action planning approach to achieve consensus on a set of principles., Results: Eight interconnected foundational principles built around rural regions and rural people were identified: FP1, grow your own "connected to" place; FP2, select trainees invested in rural practice; FP3, ground training in community need; FP4, rural immersion - not exposure; FP5, optimise and invest in general medicine; FP6, include service and academic learning components; FP7, join up the steps in rural training; and FP8, plan sustainable specialist roles., Conclusion: These eight principles can guide training and professional support to build a sustainable rural physician workforce. Application of the principles, and coordinated action by stakeholders and the responsible organisations, are needed at national, state and local levels to achieve a sustainable rural physician workforce., (© 2021 AMPCo Pty Ltd.)
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- 2021
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30. Gaps in Care and Support for Patients With Advanced Breast Cancer: A Report From the Advanced Breast Cancer Global Alliance.
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Fallowfield L, Boyle FM, Travado L, Kiely BE, Jewell P, Aubel D, and Cardoso F
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- Caregivers, Family, Female, Humans, Portugal, Breast Neoplasms therapy, Quality of Life
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Purpose: Although new therapeutic options continue to improve disease-related outcomes in advanced breast cancer (ABC), enhanced focus is needed to improve quality of life for patients currently living with ABC., Methods: In November 2019, a multidisciplinary workshop to explore patient perceptions of their information and support needs was held at the ABC Global Alliance Annual Meeting in Lisbon, Portugal. Ninety-two attendees from 27 countries participated in the workshop., Results: Several key unmet needs were identified and discussed in the workshop, including the following: (1) Significant patient knowledge gaps exist related to the diagnosis and management of ABC, and the availability of patient-focused information to support these gaps in knowledge remains limited. (2) The development of meaningful relationships between patients and health care professionals, and the role of patients in decision making, is often overlooked for patients with ABC. (3) Multidisciplinary care approaches are crucial for patients with ABC; however, these often lack effective coordination. (4) Access to clinical trials for ABC also remains limited. (5) Caregivers, friends, and family members do not receive sufficient guidance to support patients with ABC and manage their own well-being., Conclusion: The variety of unmet needs explored in the workshop demonstrates that patients with ABC still face considerable challenges related to quality of care and support, which will not be resolved until tangible action is taken. Issues highlighted in the workshop should be prioritized by working groups to shape the development of community-based solutions. There is a need for the global community to act proactively to maximize awareness of these ongoing unmet needs and existing resources, while socializing and building new initiatives and resources that will help to close these gaps for patients., Competing Interests: Lesley FallowfieldHonoraria: Voluntis, Genomic Health, NanoString Technologies, Novartis, Pfizer, MSD, Novartis, AbbVie, Clovis OncologyConsulting or Advisory Role: Puma Biotechnology, Voluntis, AstraZeneca, Takeda, Genomic Health/Exact Sciences, Lilly, Seagen, RocheResearch Funding: Bristol Myers Squibb, Novartis, LillyTravel, Accommodations, Expenses: Genomic Health Frances M. BoyleHonoraria: Lilly, Eisai, RocheConsulting or Advisory Role: Roche, Lilly, Novartis, PfizerTravel, Accommodations, Expenses: NovartisOther Relationship: Paxman, Breast Cancer Network of Australia, Clinical Oncology Society of Australia (COSA), PamgeneUncompensated Relationships: Paxman Belinda E. KielyHonoraria: NovartisConsulting or Advisory Role: Roche Patti JewellEmployment: PfizerStock and Other Ownership Interests: Pfizer, MerckTravel, Accommodations, Expenses: Pfizer Dawn AubelEmployment: NovartisStock and Other Ownership Interests: Novartis Fatima CardosoConsulting or Advisory Role: Roche, Novartis, Pfizer, AstraZeneca, Teva, Astellas Pharma, Merus, Celgene, Eisai, Daiichi Sankyo, Genentech, Merck Sharp & Dohme, Sanofi, Pierre Fabre, Macrogenics, Amgen, GE Healthcare, GlaxoSmithKline, Mylan, Mundipharma, Seattle Genetics, Samsung Bioepis, Medscape, Prime OncologyTravel, Accommodations, Expenses: Pfizer, Roche, AstraZenecaNo other potential conflicts of interest were reported.
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- 2021
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31. A systematic literature review of attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on consent.
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Hutchings E, Loomes M, Butow P, and Boyle FM
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- Humans, Informed Consent, Systematic Reviews as Topic, Trust, Attitude, Research Personnel
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Background: We aimed to synthesise data on issues related to stakeholder perceptions of consent for the use of secondary data. To better understand the current literature available, we conducted a systematic literature review of healthcare consumer attitudes towards the secondary use and sharing of health administrative and clinical trial data., Methods: EMBASE/MEDLINE, Cochrane Library, PubMed, CINAHL, Informit Health Collection, PROSPERO Database of Systematic Reviews, PsycINFO and ProQuest databases were searched. Eligible articles included those reporting qualitative or quantitative original research and published in English. No restrictions were placed on publication dates, study design or disease setting. One author screened articles for eligibility and two authors were involved in the full-text review process. Conflicts were resolved by consensus. Quality and bias were assessed using the QualSyst criteria for qualitative studies., Results: This paper focuses on a subset of 47 articles identified from the wider search and focuses on the issue of consent. Issues related to privacy, trust and transparency, and attitudes of healthcare professionals and researchers to secondary use and sharing of data have been dealt with in previous publications. Studies included a total of 216,149 respondents. Results indicate that respondents are generally supportive of using health data for research, particularly if the data is de-identified or anonymised. The requirement by participants to obtain consent prior to the use of health data for research was not universal, nor is the requirement for this always supported by legislation. Many respondents believed that either no consent or being informed of the research, but not providing additional consent, were sufficient., Conclusions: These results indicate that individuals should be provided with information and choice about how their health data is used and, where feasible, a mechanism to opt-out should be provided. To increase the acceptability of using health data for research, health organisations and data custodians must provide individuals with concise information about data protection mechanisms and under what circumstances their data may be used and by whom., Systematic Review Registration: PROSPERO CRD42018110559 (update June 2020).
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- 2021
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32. Implementation and evaluation of a quality improvement initiative to reduce late gestation stillbirths in Australia: Safer Baby Bundle study protocol.
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Andrews CJ, Ellwood D, Middleton PF, Gordon A, Nicholl M, Homer CSE, Morris J, Gardener G, Coory M, Davies-Tuck M, Boyle FM, Callander E, Bauman A, and Flenady VJ
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- Australia, Female, Humans, Infant, Pregnancy, Program Evaluation, Research Design, Risk Factors, Fetal Death prevention & control, Maternal Health Services standards, Quality Improvement organization & administration, Stillbirth
- Abstract
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.
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- 2020
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33. Addressing stillbirth inequities in Australia: Steps towards a better future.
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Rumbold AR, Yelland J, Stuart-Butler D, Forbes M, Due C, Boyle FM, and Middleton P
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- Australia, Cultural Competency, Female, Health Services Accessibility, Humans, Native Hawaiian or Other Pacific Islander, Pregnancy, Refugees, Transients and Migrants, Culturally Competent Care, Fetal Death prevention & control, Health Services, Indigenous organization & administration, Healthcare Disparities, Maternal Health Services organization & administration, Stillbirth ethnology
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Persistent disparities in stillbirth risk and care are present in Australia. Eliminating these disparities is possible with a commitment to enhancing and scaling up models of culturally safe maternity care shown to be effective for Aboriginal and Torres Strait Islander women and those of migrant and refugee backgrounds. Campaigns to improve public awareness of stillbirth also play an important role in reducing stillbirth risk and consequences. To achieve reach and impact in communities at risk, messaging needs to be framed around the social and cultural context of women's lives. Here we describe important initiatives underway within the Stillbirth Centre of Research Excellence to develop a coordinated national approach to stillbirth prevention and care in communities that bear a disproportionate burden of stillbirth., (Copyright © 2020. Published by Elsevier Ltd.)
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- 2020
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34. A systematic literature review of researchers' and healthcare professionals' attitudes towards the secondary use and sharing of health administrative and clinical trial data.
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Hutchings E, Loomes M, Butow P, and Boyle FM
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- Humans, Information Dissemination, Qualitative Research, Trust, Attitude of Health Personnel, Research Personnel
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A systematic literature review of researchers and healthcare professionals' attitudes towards the secondary use and sharing of health administrative and clinical trial data was conducted using electronic data searching. Eligible articles included those reporting qualitative or quantitative original research and published in English. No restrictions were placed on publication dates, study design, or disease setting. Two authors were involved in all stages of the review process; conflicts were resolved by consensus. Data was extracted independently using a pre-piloted data extraction template. Quality and bias were assessed using the QualSyst criteria for qualitative studies. Eighteen eligible articles were identified, and articles were categorised into four key themes: barriers, facilitators, access, and ownership; 14 subthemes were identified. While respondents were generally supportive of data sharing, concerns were expressed about access to data, data storage infrastructure, and consent. Perceptions of data ownership and acknowledgement, trust, and policy frameworks influenced sharing practice, as did age, discipline, professional focus, and world region. Young researchers were less willing to share data; they were willing to share in circumstances where they were acknowledged. While there is a general consensus that increased data sharing in health is beneficial to the wider scientific community, substantial barriers remain. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018110559.
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- 2020
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35. A systematic literature review of health consumer attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on privacy, trust, and transparency.
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Hutchings E, Loomes M, Butow P, and Boyle FM
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- Attitude to Health, Humans, Trust, Privacy, Text Messaging
- Abstract
We aimed to synthesise data on issues related to stakeholder perceptions of privacy, trust, and transparency in use of secondary data. A systematic literature review of healthcare consumer attitudes towards the secondary use and sharing of health administrative and clinical trial data was conducted. EMBASE/MEDLINE, Cochrane Library, PubMed, CINAHL, Informit Health Collection, PROSPERO Database of Systematic Reviews, PsycINFO, and ProQuest databases were searched. Eligible articles included those reporting qualitative or quantitative original research and published in English. No restrictions were placed on publication dates, study design or disease setting. One author screened articles for eligibility, and two authors were involved in the full text review process. Data was extracted using a pre-piloted data extraction template by one author and checked by another. Conflicts were resolved by consensus. Quality and bias were assessed using the QualSyst criteria for qualitative and quantitative studies. This paper focuses on a subset of 35 articles identified from the wider search which focus on issues of privacy, trust, and transparency. Studies included a total of 56,365 respondents. Results of this systematic literature review indicate that while respondents identified advantages in sharing health data, concerns relating to trust, transparency, and privacy remain. Organisations collecting health data and those who seek to share data or undertake secondary data analysis should continue to develop trust, transparency, and privacy with healthcare consumers through open dialogue and education. Consideration should be given to these issues at all stages of data collection including the conception, design, and implementation phases. While individuals understand the benefits of health data sharing for research purposes, ensuring a balance between public benefit and individual privacy is essential. Researchers and those undertaking secondary data analysis need to be cognisant of these key issues at all stages of their research. Systematic review registration: PROSPERO registration number CRD42018110559 (update June 2020).
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- 2020
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36. Survey of Australian maternity hospitals to inform development and implementation of a stillbirth prevention 'bundle of care'.
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Andrews CJ, Ellwood D, Middleton PF, Homer CSE, Reinebrant HE, Donnolley N, Boyle FM, Gordon A, Nicholl M, Morris J, Gardener G, Davies-Tuck M, Wallace EM, and Flenady VJ
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- Australia, Cross-Sectional Studies, Female, Fetal Movement, Hospitals, Maternity, Humans, Pregnancy, Surveys and Questionnaires, Maternal Health Services statistics & numerical data, Perinatal Care statistics & numerical data, Perinatal Death prevention & control, Stillbirth
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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., (Copyright © 2019 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)
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- 2020
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37. The RESPECT Study for consensus on global bereavement care after stillbirth.
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Shakespeare C, Merriel A, Bakhbakhi D, Blencowe H, Boyle FM, Flenady V, Gold K, Horey D, Lynch M, Mills TA, Murphy MM, Storey C, Toolan M, and Siassakos D
- Subjects
- Adult, Consensus, Delphi Technique, Empathy, Female, Health Personnel education, Humans, Postnatal Care methods, Postnatal Care psychology, Pregnancy, Professional-Patient Relations, Respect, Surveys and Questionnaires, Bereavement, Quality of Health Care standards, Stillbirth psychology
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Objective: To develop global consensus on a set of evidence-based core principles for bereavement care after stillbirth., Methods: A modified policy-Delphi methodology was used to consult international stakeholders and healthcare workers with experience in stillbirth between September 2017 and October 2018. Five sequential rounds involved two expert stakeholder meetings and three internet-based surveys, including a global internet-based survey targeted at healthcare workers in a wide range of settings., Results: Initially, 23 expert stakeholders considered 43 evidence-based themes derived from systematic reviews, identifying 10 core principles. The global survey received 236 responses from participants in 26 countries, after which nine principles met a priori criteria for inclusion. The final stakeholder meeting and internet-based survey of all participants confirmed consensus on eight core principles. Highest quality bereavement care should be enabled through training of healthcare staff to reduce stigma and establish respectful care, including acknowledgement and support for grief responses, and provision for physical and psychologic needs. Women and families should be supported to make informed choices, including those concerning their future reproductive health., Conclusion: Consensus was established for eight principles for stillbirth bereavement care. Further work should explore implementation and involve the voices of women and families globally., (© 2020 International Federation of Gynecology and Obstetrics.)
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- 2020
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38. Clinical practice guidelines for perinatal bereavement care - An overview.
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Boyle FM, Horey D, Middleton PF, and Flenady V
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- Australia, Communication, Female, Humans, Infant, Newborn, Maternal Health Services organization & administration, New Zealand, Parents psychology, Perinatal Care standards, Perinatal Death, Pregnancy, Quality of Health Care, Bereavement, Practice Guidelines as Topic, Stillbirth psychology
- Abstract
Background: High quality perinatal bereavement care is critical for women and families following stillbirth or newborn death. It is a challenging area of practice and a difficult area for guideline development due to a sparse and disparate evidence base., Aim: We present an overview of the newly updated Perinatal Society of Australia and New Zealand/Stillbirth Centre of Research Excellence guideline for perinatal bereavement care. The guideline aims to provide clear guidance for maternity health care providers and their services to support the provision of care that meets the needs of bereaved parents., Discussion: The Guideline for Respectful and Supportive Perinatal Bereavement Care is underpinned by a review of current research combined with extensive stakeholder consultation that included parents and their organisations and clinicians from a variety of disciplines. The Guideline contains 49 recommendations that reflect five fundamental goals of care: good communication; shared decision-making; recognition of parenthood; effective support; and organisational response., Conclusion: Best available research, parents' lived experiences and maternity care providers' insights have contributed to a set of implementable recommendations that address the needs of bereaved parents., (Copyright © 2019 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)
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- 2020
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39. Learning from regret.
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Boyle FM, Allen J, Rey-Conde T, and North JB
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- Aged, Aged, 80 and over, Clinical Decision-Making, Empathy, Humans, Physician-Patient Relations, Retrospective Studies, Surgeons statistics & numerical data, Surgical Procedures, Operative mortality, Surgical Procedures, Operative psychology, Surveys and Questionnaires, Uncertainty, Emotions, Learning, Surgeons psychology
- Abstract
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., (© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.)
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- 2020
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40. My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.
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Flenady V, Gardener G, Boyle FM, Callander E, Coory M, East C, Ellwood D, Gordon A, Groom KM, Middleton PF, Norman JE, Warrilow KA, Weller M, Wojcieszek AM, and Crowther C
- Subjects
- Adult, Australia epidemiology, Female, Health Knowledge, Attitudes, Practice, Humans, Mobile Applications, New Zealand epidemiology, Pregnancy, Randomized Controlled Trials as Topic, Stillbirth epidemiology, Fetal Movement, Patient Acceptance of Health Care psychology, Patient Education as Topic methods, Prenatal Care methods, Stillbirth psychology
- Abstract
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.
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- 2019
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41. Risk of emergency hospitalisation and survival outcomes following adjuvant chemotherapy for early breast cancer in New South Wales, Australia.
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Tervonen HE, Chen TYT, Lin E, Boyle FM, Moylan EJ, Della-Fiorentina SA, Beith J, Johnston A, and Currow DC
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- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin administration & dosage, Chemotherapy, Adjuvant, Chemotherapy-Induced Febrile Neutropenia epidemiology, Chemotherapy-Induced Febrile Neutropenia etiology, Cohort Studies, Cyclophosphamide administration & dosage, Docetaxel administration & dosage, Emergencies, Female, Fever chemically induced, Humans, Infections chemically induced, Kaplan-Meier Estimate, Logistic Models, Mastectomy, Mastectomy, Segmental, Middle Aged, Neutropenia chemically induced, New South Wales epidemiology, Odds Ratio, Proportional Hazards Models, Retrospective Studies, Risk Factors, Trastuzumab administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms drug therapy, Fever epidemiology, Hospitalization statistics & numerical data, Infections epidemiology, Neutropenia epidemiology, Survival Rate
- Abstract
Objective: To examine risk of emergency hospital admission and survival following adjuvant chemotherapy for early breast cancer., Methods: Linked data from New South Wales population-based and clinical cancer registries (2008-2012), hospital admissions, official death records and pharmaceutical benefit claims. Women aged ≥18 years receiving adjuvant chemotherapy for early-stage operable breast cancer in NSW public hospitals were included. Odds ratios (OR) for emergency hospitalisation within 6 months following chemotherapy initiation were estimated using logistic regression and survival using Kaplan-Meier and Cox proportional hazards methods., Results: A total of 3,950 women were included and 30.6% were hospitalised. The most common principal diagnosis at admission was neutropenia (30.8%). Women receiving docetaxel/carboplatin/trastuzumab (TCH) and docetaxel/cyclophosphamide (TC) were the most frequently hospitalised. After adjustment for demographic and clinical factors, the increased risk of hospitalisation for TCH and TC remained compared with doxorubicin/cyclophosphamide 3-weekly (OR 1.71, 95% confidence interval [CI] 1.24-2.37 and OR 1.47, 95% CI 1.17-1.85 respectively). Five-year overall survival was similar for women who were (92.2%, 95% CI 90.7-93.8) and were not hospitalised (93.1%, 95% CI 92.1-94.1)., Conclusion: Emergency hospitalisations following chemotherapy for early breast cancer were relatively common, especially following docetaxel-containing protocols. Further examination of reasons for admission is needed to inform actions to improve patient safety., (© 2019 John Wiley & Sons Ltd.)
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- 2019
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42. Patient-reported outcomes with neoadjuvant vs adjuvant systemic therapy for operable breast cancer.
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Zdenkowski N, Butow P, Spillane A, Douglas C, Snook K, Jones M, Oldmeadow C, Fewster S, Beckmore C, and Boyle FM
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- Adult, Anxiety etiology, Breast Neoplasms therapy, Decision Making, Disease Progression, Fear, Female, Humans, Longitudinal Studies, Middle Aged, Patient Reported Outcome Measures, Stress, Psychological etiology, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms psychology, Chemotherapy, Adjuvant psychology, Neoadjuvant Therapy psychology, Neoplasm Recurrence, Local psychology
- Abstract
Background: Neoadjuvant systemic therapy (NAST) is used for large operable or highly proliferative breast cancers. It is not known whether psychological outcomes differ according to the treatment sequence (chemotherapy or surgery first) or tumour response., Methods: This was a planned analysis of a multi-institutional single arm longitudinal study of patients considering NAST for operable breast cancer. Participants completed patient reported outcome questionnaires before and after the decision about NAST, between chemotherapy and surgery, and 12 months after diagnosis., Results: Fifty-nine women enrolled. Fourteen of 51 (28%) who received NAST experienced pathological complete response (pCR). Patients who had surgery first (n = 7) had higher baseline anxiety, and a greater decrease in anxiety at 12 months follow up, compared with patients who received NAST (n = 50) (a decrease from baseline of 34 pts vs 17 points; p = 0.033). Distress declined at a similar rate in surgery first and NAST groups. Mean satisfaction with decision score post-decision was significantly lower in the adjuvant group compared with NAST (22 vs 26, p = 0.02). No differences were seen between patients with pCR vs residual cancer in: distress, anxiety, satisfaction with decision, fear of progression, and decision regret., Conclusion: Most patients in this study proceeded with NAST when their surgeon offered it as an option. This exploratory analysis suggests that patients who chose surgery first tended to be more anxious, and had lower satisfaction with their decision, than those who had NAST. In patients who had NAST, lack of pCR does not appear to correlate with adverse psychological outcomes., (Copyright © 2019 Elsevier Ltd. All rights reserved.)
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- 2019
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43. Mobile applications providing guidance about decreased fetal movement: Review and content analysis.
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Daly LM, Boyle FM, Gibbons K, Le H, Roberts J, and Flenady V
- Subjects
- Female, Fetal Movement, Humans, Perception, Pregnancy, Stillbirth, Fetal Monitoring methods, Mobile Applications, Pregnant Women psychology, Prenatal Education methods
- Abstract
Background: Maternal perception of decreased fetal movement has clinical significance as a predictor of pregnancies at risk of adverse outcomes, including stillbirth. Increasingly, women are using mobile applications ("apps") to access information during the antenatal period. Little is known about how apps intended for use during pregnancy guide women to address fetal movement concerns., Objective: To explore information about decreased fetal movement provided through mobile apps intended for use during pregnancy., Methods: A systematic review framework was applied to the search, screening, and assessment of mobile apps. A sample of apps were downloaded in December 2016 that met inclusion criteria for accessibility, reach, relevance and quality. Data extraction was performed independently by two reviewers in January 2017. A quantitative and qualitative approach was taken to analyse data and present results., Findings: All 24 apps in the sample mentioned decreased fetal movement, but few explicitly link decreased fetal movement to stillbirth or other specific adverse outcomes. There is substantial variability in guidance for fetal movement monitoring. One-quarter of apps recommend consumption of food or drink to stimulate fetal movement, two-thirds of apps recommend "kick counting", and one-third offer a kick "counter"., Conclusion: This review is the first to assess information about decreased fetal movement available in mobile apps intended for download by pregnant women. Across the sample, this review identifies a lack of evidence-based clinical advice to guide women experiencing decreased fetal movement. As an antenatal education tool used by millions of women, accurate content about fetal movement is essential., (Copyright © 2018 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)
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- 2019
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44. Understanding mothers' decision-making needs for autopsy consent after stillbirth: Framework analysis of a large survey.
- Author
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Schirmann A, Boyle FM, Horey D, Siassakos D, Ellwood D, Rowlands I, and Flenady V
- Subjects
- Adult, Bereavement, Female, Humans, Informed Consent, Internationality, Mothers psychology, Surveys and Questionnaires, Autopsy, Decision Making, Mothers statistics & numerical data, Stillbirth
- Abstract
Background: Experiencing stillbirth is devastating and leaves parents searching for causes. Autopsy is the gold standard for investigation, but deciding to consent to this procedure is very difficult for parents. Decision support in the form of clear, consistent, and parent-centered information is likely to be helpful. The aims of this study were to understand the influences on parents' decisions about autopsy after stillbirth and to identify attributes of effective decision support that align with parents' needs., Methods: Framework analysis using the Decision Drivers Model was used to analyze responses from 460 Australian and New Zealand (ANZ) mothers who took part in a multi-country online survey of parents' experiences of stillbirth. The main outcomes examined were factors influencing mothers' decisions to consent to autopsy after stillbirth., Results: Free-text responses from 454 ANZ mothers referenced autopsy, yielding 1221 data segments for analysis. The data confirmed the difficult decision autopsy consent entails. Mothers had a strong need for answers coupled with a strong need to protect their baby. Four "decision drivers" were confirmed: preparedness for the decision; parental responsibility; possible consequences; and role of health professionals. Each had the capacity to influence decisions for or against autopsy. Also prominent were the "aftermath" of the decision: receiving the results; and decisional regret or uncertainty., Conclusions: The influences on decisions about autopsy are diverse and unpredictable. Effective decision support requires a consistent and structured approach that is built on understanding of parents' needs., (© 2018 Wiley Periodicals, Inc.)
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- 2018
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45. The Effect of Mobile App Interventions on Influencing Healthy Maternal Behavior and Improving Perinatal Health Outcomes: Systematic Review.
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Daly LM, Horey D, Middleton PF, Boyle FM, and Flenady V
- Abstract
Background: Perinatal morbidity and mortality are significant public health issues with an enduring impact on the health and well-being of women and their families. Millions of pregnant women now download and use mobile applications to access, store, and share health information. However, little is known about the consequences. An investigation of their impact on perinatal health outcomes is particularly topical., Objective: To determine the effects of mobile app interventions during pregnancy on influencing healthy maternal behavior and improving perinatal health outcomes., Methods: Searches of PubMed, Embase, the Cochrane Library, CINAHL, WHO Global Health Library, POPLINE, and CABI Global Health were conducted with no date or language restrictions. Randomized and non-randomized studies were included if they reported perinatal health outcomes of interventions targeting pregnant women, using mobile apps compared with other communication modalities or with standard care. The primary outcome measure was the change in maternal behaviors (as defined by trial authors), by intervention goals. Two reviewers independently extracted data using standardized forms., Results: Four randomized controlled trials (RCTs) involving 456 participants were included. All studies targeted participants in early pregnancy; however, wide variation was evident in participant characteristics, intervention, and study outcomes measures. Three trials were based in hospital settings, comparing women using mobile apps with routine antenatal care. One community-based trial gave all participants a device to promote physical activity; the intervention arm was also given a mobile app. All studies reported data for the primary outcome measure, describing some benefit from the intervention compared with controls. However, few statistically significant primary or secondary outcomes were reported. Due to insufficient data, the planned meta-analysis and subgroup analyses were not performed., Conclusions: Due to limited numbers, heterogeneity of interventions, comparators, and outcome measures, no firm conclusions can be drawn on the effects of mobile application interventions during pregnancy on maternal knowledge, behavior change, and perinatal health outcomes. As millions of women utilize mobile apps during pregnancy, rigorous studies are essential for health care and maternity care providers to optimally design, implement, and evaluate interventions., (©Lisa M Daly, Dell Horey, Philippa F Middleton, Frances M Boyle, Vicki Flenady. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 09.08.2018.)
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- 2018
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46. Single-Arm Longitudinal Study to Evaluate a Decision Aid for Women Offered Neoadjuvant Systemic Therapy for Operable Breast Cancer.
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Zdenkowski N, Butow P, Spillane A, Douglas C, Snook K, Jones M, Oldmeadow C, Fewster S, Beckmore C, and Boyle FM
- Subjects
- Adult, Aged, Breast Neoplasms mortality, Combined Modality Therapy, Female, Humans, Longitudinal Studies, Middle Aged, Neoadjuvant Therapy, Neoplasm Metastasis, Neoplasm Staging, Patient Reported Outcome Measures, Treatment Outcome, Breast Neoplasms pathology, Breast Neoplasms therapy, Clinical Decision-Making, Decision Support Techniques
- Abstract
Background: Neoadjuvant systemic therapy (NAST) is an increasingly used treatment option for women with large operable or highly proliferative breast cancer. With equivalent survival outcomes between NAST and up-front surgery, the situation-specific preference-sensitive nature of the decision makes it suitable for a decision aid (DA). This study aimed to develop and evaluate a DA for this population. Methods: A DA booklet was developed according to international standards, including information about adjuvant and neoadjuvant treatment, outcome probabilities, and a values clarification exercise. Eligible women, considered by investigators as candidates for NAST, were enrolled in a multi-institutional, single-arm, longitudinal study. Patient-reported outcome measure questionnaires were completed pre- and post-DA, between chemotherapy and surgery, and at 12 months. Outcomes were feasibility (percentage of eligible patients accessing the DA); acceptability to patients (percentage who would recommend it to others) and clinicians (percentage who would use the DA in routine practice); and decision-related outcomes. Results: From 77 eligible women, 59 were enrolled, of whom 47 (79.7%; 95% CI, 69.4-89.9) reported having read the DA; 51 completed the first post-DA questionnaire. Of these 51, 41 participants (80.4%; 95% CI, 69.5-91.3) found the DA useful for their decision about NAST. Of 18 responding investigators, 16 (88.9%; 95% CI, 74.4-103.4) indicated they would continue to use the DA in routine practice. Post-DA, decisional conflict decreased significantly ( P <.01); anxiety and distress decreased significantly; and 86.3% (95% CI, 73.7-94.3) achieved at least as much decisional control as they desired. Conclusions: This DA was feasible and acceptable to patients and clinicians, and improvement in decision-related outcomes was demonstrated when used in combination with clinical consultations. This DA could safely be implemented into routine practice for women considering NAST for operable breast cancer., (Copyright © 2018 by the National Comprehensive Cancer Network.)
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- 2018
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47. Care in subsequent pregnancies following stillbirth: an international survey of parents.
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Wojcieszek AM, Boyle FM, Belizán JM, Cassidy J, Cassidy P, Erwich J, Farrales L, Gross MM, Heazell A, Leisher SH, Mills T, Murphy M, Pettersson K, Ravaldi C, Ruidiaz J, Siassakos D, Silver RM, Storey C, Vannacci A, Middleton P, Ellwood D, and Flenady V
- Subjects
- Adult, Developed Countries, Developing Countries, Female, Humans, Internet, Male, Middle Aged, Quality of Health Care, Surveys and Questionnaires, Young Adult, Parents psychology, Prenatal Care standards, Stillbirth psychology
- Abstract
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., (© 2016 Royal College of Obstetricians and Gynaecologists.)
- Published
- 2018
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48. Inhibition of basal-like breast cancer growth by FTY720 in combination with epidermal growth factor receptor kinase blockade.
- Author
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Martin JL, Julovi SM, Lin MZ, de Silva HC, Boyle FM, and Baxter RC
- Subjects
- Animals, Caspase 3, Cell Line, Tumor, Cell Proliferation drug effects, Drug Resistance, Neoplasm drug effects, ErbB Receptors antagonists & inhibitors, Fingolimod Hydrochloride administration & dosage, Gefitinib, Gene Expression Regulation, Neoplastic drug effects, Humans, Hyaluronan Receptors genetics, Mice, Protein Kinase Inhibitors, Quinazolines administration & dosage, Signal Transduction drug effects, Triple Negative Breast Neoplasms genetics, Xenograft Model Antitumor Assays, ErbB Receptors genetics, Insulin-Like Growth Factor Binding Protein 3 genetics, Phosphotransferases (Alcohol Group Acceptor) genetics, Triple Negative Breast Neoplasms drug therapy
- Abstract
Background: New molecular targets are needed for women with triple-negative breast cancer (TNBC). This pre-clinical study investigated the combination of the EGFR inhibitor gefitinib with the sphingosine kinase (SphK) inhibitor FTY720 (Fingolimod), aiming to block tumorigenic signaling downstream of IGFBP-3, which is abundantly expressed in basal-like TNBC., Methods: In studies of breast cancer cell growth in culture, proliferation was monitored by IncuCyte live-cell imaging, and protein abundance was determined by western blotting. In vivo studies of mammary tumor growth used two models: orthotopic xenograft tumors derived from three basal-like TNBC cell lines, grown in immune-deficient mice, and syngeneic murine 4T1 tumors grown in immune-competent mice. Protein abundance in tumor tissue was assessed by immunohistochemistry., Results: Quantitated by live-cell imaging, the inhibitor combination showed synergistic cytostatic activity in basal-like cell lines across several TNBC molecular subtypes, the synergy being decreased by IGFBP-3 downregulation. Suppression of the tumorigenic mediator CD44 by gefitinib was potentiated by FTY720, consistent with CD44 involvement in the targeted pathway. In MDA-MB-468 and HCC1806 orthotopic TNBC xenograft tumors in nude mice, the drug combination inhibited tumor growth and prolonged mouse survival, although this effect was not significant for the gefitinib-resistant cell line HCC70. Combination treatment of murine 4T1 TNBC tumors in syngeneic BALB/c mice was more effective in immune-competent than immune-deficient (nude) mice, and a relative loss of tumor CD3 (T-cell) immunoreactivity caused by FTY720 treatment alone was alleviated by the drug combination, suggesting that, even at an FTY720 dose causing relative lymphopenia, the combination is still effective in an immune-competent setting. Immunohistochemistry of xenograft tumors showed significant enhancement of caspase-3 cleavage and suppression of Ki67 and phospho-EGFR by the drug combination, but SphK1 downregulation occurred only in MDA-MB-468 tumors, so is unlikely to be integral to treatment efficacy., Conclusions: Our data indicate that targeting IGFBP-3-dependent signaling pathways through gefitinib-FTY720 co-therapy may be effective in many basal-like breast cancers, and suggest tissue IGFBP-3 and CD44 measurement as potential biomarkers of treatment efficacy.
- Published
- 2017
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49. Randomized Evaluation of Cognitive-Behavioral Therapy and Graded Exercise Therapy for Post-Cancer Fatigue.
- Author
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Sandler CX, Goldstein D, Horsfield S, Bennett BK, Friedlander M, Bastick PA, Lewis CR, Segelov E, Boyle FM, Chin MTM, Webber K, Barry BK, and Lloyd AR
- Subjects
- Breast Neoplasms psychology, Breast Neoplasms therapy, Colonic Neoplasms psychology, Colonic Neoplasms therapy, Comorbidity, Fatigue psychology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Patient Education as Topic, Severity of Illness Index, Treatment Outcome, Breast Neoplasms complications, Cognitive Behavioral Therapy, Colonic Neoplasms complications, Exercise Therapy, Fatigue etiology, Fatigue therapy
- Abstract
Context: Cancer-related fatigue is prevalent and disabling. When persistent and unexplained, it is termed post-cancer fatigue (PCF). Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) may improve symptoms and functional outcomes., Objectives: To evaluate the outcomes of a randomized controlled trial, which assigned patients with post-cancer fatigue to education, or 12 weeks of integrated cognitive-behavioral therapy (CBT) and graded exercise therapy (GET)., Methods: Three months after treatment for breast or colon cancer, eligible patients had clinically significant fatigue, no comorbid medical or psychiatric conditions that explained the fatigue, and no evidence of recurrence. The CBT/GET arm included individually tailored consultations at approximately two weekly intervals. The education arm included a single visit with clinicians describing the principles of CBT/GET and a booklet. The primary outcome was clinically significant improvement in self-reported fatigue (Somatic and Psychological HEalth REport 0-12), designated a priori as greater than one SD of improvement in fatigue score. The secondary outcome was associated improvement in function (role limitation due to physical health problems-36-Item Short Form Health Survey 0-100) comparing baseline, end treatment (12 weeks), and follow-up (24 weeks)., Results: There were 46 patients enrolled, including 43 women (94%), with a mean age of 51 years. Fatigue severity improved in all subjects from a mean of 5.2 (±3.1) at baseline to 3.9 (±2.8) at 12 weeks, suggesting a natural history of improvement. Clinically significant improvement was observed in 7 of 22 subjects in the intervention group compared with 2 of 24 in the education group (P < 0.05, χ
2 ). These subjects also had improvement in functional status compared with nonresponders (P < 0.01, t-test)., Conclusion: Combined CBT/GET improves fatigue and functional outcomes for a subset of patients with post-cancer fatigue. Further studies to improve the response rate and the magnitude of the benefit are warranted., (Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)- Published
- 2017
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50. How participation in surgical mortality audit impacts surgical practice.
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Lui CW, Boyle FM, Wysocki AP, Baker P, D'Souza A, Faint S, Rey-Conde T, and North JB
- Subjects
- Australia, Clinical Competence, Cross-Sectional Studies, Humans, Surgical Procedures, Operative adverse effects, Surveys and Questionnaires, Attitude of Health Personnel, Medical Audit, Practice Patterns, Physicians', Surgical Procedures, Operative mortality
- Abstract
Background: Surgical mortality audit is an important tool for quality assurance and professional development but little is known about the impact of such activity on professional practice at the individual surgeon level. This paper reports the findings of a survey conducted with a self-selected cohort of surgeons in Queensland, Australia, on their experience of participating in the audit and its impact on their professional practice, as well as implications for hospital systems., Methods: The study used a descriptive cross-sectional survey design. All surgeons registered in Queensland in 2015 (n = 919) were invited to complete an anonymous online questionnaire between September and October 2015. 184 surgeons completed and returned the questionnaire at a response rate of 20%., Results: Thirty-nine percent of the participants reported that involvement in the audit process affected their clinical practice. This was particularly the case for surgeons whose participation included being an assessor. Thirteen percent of the participants had perceived improvement to hospital practices or advancement in patient care and safety as a result of audit recommendations. Analysis of the open-ended responses suggested the audit experience had led surgeons to become more cautious, reflective in action and with increased confidence in best practice, and recognise the importance of effective communication and clear documentation., Conclusions: This is the first study to examine the impact of participation in a mortality audit process on the professional practice of surgeons. The findings offer evidence for surgical mortality audit as an effective strategy for continuous professional development and for improving patient safety initiatives.
- Published
- 2017
- Full Text
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