Contralateral prophylactic mastectomy for unilateral breast cancer in women at average risk: Systematic review of patient reported outcomes.

OBJECTIVE: The rate of contralateral prophylactic mastectomy (CPM) in women with early, unilateral cancer is relatively high and is increasing around the world a previous study. Women choose this option for many reasons other than reducing their risk of future cancer, including symmetry, reasons related to breast reconstruction and attempting to manage fear of recurrence. This systematic review evaluated patient-reported quality of life outcomes following CPM. METHODS: A literature search of MEDLINE, PubMed and PsycINFO was performed to February 2019. Abstracts and full-text articles were assessed for eligibility according to pre-determined criteria. Data were extracted into evidence tables for analysis. RESULTS: A total of 19 articles met eligibility criteria and were included in analysis. These included patient-reported data from 6088 women undergoing CPM. They reported high levels of satisfaction with the decision for surgery, low levels of decisional regret and high satisfaction with cosmesis and reconstruction. Breast-specific and general quality of life was high overall but was even better in women choosing breast reconstruction after surgery. Fear of cancer recurrence was high after CPM. Depression, distress and a negative impact on body image were evident; however, levels were high in both CPM and non-CPM groups. CONCLUSIONS: This study provides information that can be used by surgeons and psychologists when counselling women about the potential benefits and harms of CPM. This process must include discussion about the trade-offs such as body image issues and ongoing fear of recurrence in addition to the positive aspect of cancer risk reduction. Women are unlikely to regret their decision for CPM.

Principles of patient-centred care and barriers to their implementation: a case study of breast reconstruction in Australia.

PURPOSE: "Patient-centred care" is widely promoted as an ideal goal of health care systems, but is often difficult to achieve in practice. This article has three aims: to develop an original set of generalisable patient-centred care principles (PCCPs); to identify barriers to the implementation of these principles in a real-world setting, using breast reconstruction (BR) services in Australia as a case study; and to document examples of successful patient-centred care in relation to BR. METHODS: Semi-structured interviews (n = 90) were conducted with 31 breast and plastic reconstructive surgeons, 37 breast cancer health professionals and 22 women who underwent mastectomy as part of their breast cancer treatment and were dissatisfied with their BR experiences. RESULTS: Ten broad PCCPs were derived from our participant interviews. These principles comprised the following: maximising patient choice, access to services, patient and family support and appropriateness of information; minimising patient costs and physical and psychosocial morbidity; and facilitating informed decision-making, interdisciplinary patient management and evidence-informed practice. While the major barriers to the implementation of these PCCPs in relation to BR were resource driven, surgeon-related factors were also identified. CONCLUSIONS: These PCCPs highlight areas of need but also provide examples of high quality patient-centred care. They may help to guide a national discussion about minimum standards of BR practice, while allowing for some necessary regional and cultural variation. They also have the potential to be applied more widely to the provision of a range of health services within Australia or internationally.

Increasing access to breast reconstruction for women living in underserved non-metropolitan areas of Australia.

PURPOSE: The potential quality of life benefits of breast reconstruction (BR) for women who have undergone mastectomy for breast cancer have long been recognised. While many women will not want to have BR, international best-practice guidance mandates that all should be given the choice. The aim of this article is to highlight potential policies to support patients' informed discussion of BR options and to improve access to BR for women living in underserved locations. METHODS: Ninety semi-structured interviews were conducted from May 2015 to May 2017 with a convenience sample of 31 breast reconstructive surgeons, 37 breast cancer health professionals and a purposive sample of 22 women who underwent mastectomy as part of their breast cancer treatment. Breast, plastic reconstructive surgeons and health professionals based in major cities also provided information about how they cared for patients from more remote areas. RESULTS: Analysis of interview data revealed a range of barriers that were grouped into four major categories describing issues for women living outside major cities: population characteristics associated with lower socioeconomic status; locational barriers including limited health services resources and distance; administrative barriers such as hospital policies and inadequate support for women who need to travel; and surgical workforce recruitment barriers. CONCLUSIONS: Suggestions for potential solutions included the following: greater geographical centralisation of BR services within major cities; the creation of designated breast centres with minimum caseload requirements similar to the UK's system; and a buddy system, whereby smaller hospitals network with multidisciplinary teams based in larger hospitals.

The impact on Australian women of lack of choice of breast reconstruction options: A qualitative study.

BACKGROUND: Many studies have demonstrated the positive impact of breast reconstruction (BR) on women following mastectomy for breast cancer. However, women's preferences for BR are not always considered by surgeons prior to mastectomy. The aim of this research is threefold: to document the negative impact lack of choice has had on some Australian women; to explore potential reasons for the absence of informed discussion; and to develop a prompt list of discussion topics to aid informed decision making. METHODS: This research is part of a larger study using semistructured telephone or face-to-face interviews with women with breast cancer, surgeons, and health professionals to explore ways of improving access to BR. This article focuses on responses from all 22 women who reported negative BR experiences and seven of 31 surgeons who had made comments relevant to limiting BR discussion and choice. RESULTS: The impact of a lack of information or choice at the time of mastectomy was often extreme and long-term. Breast surgeons are the gate keepers to accessing BR but too often appeared to limit women's choices. Interviews revealed cases where BR was not offered prior to mastectomy, even though it was available locally; where BR was not available locally, but patients were not informed about BR options available in other locations; where only delayed BR options were discussed; and where the type of BR being offered did not match patient preferences. CONCLUSION: We have suggested essential BR discussion points to be raised with all clinically eligible women interested in considering BR.

Decisional regret and choice of breast reconstruction following mastectomy for breast cancer: A systematic review.

OBJECTIVE: Women facing mastectomy for breast cancer should have the option of considering whether they would like breast reconstruction (BR), and if so, what type and when. Previous research has demonstrated that some women will come to regret their decision about BR. We aim to summarise the evidence about the prevalence of decisional regret (DR) associated with BR choices and identify factors influencing vulnerability to DR. METHODS: A systematic review of the literature reporting BR-related DR published between January 1994 and February 2017 identified 254 initial search results. Thirteen publications from 12 studies (5672 participants) met the selection criteria and were included in the final review. Each article was allocated a quality score out of 24. RESULTS: Overall, DR levels were reported as low and stable, although direct comparison across studies was limited by inconsistencies in measurement and reporting methods. Estimates of DR scores ranged from 9.3/100 to 5.4/20. All studies identified a relationship between higher levels of DR and an insufficient amount, inadequate quality, or unclear nature of information provided to women prior to undergoing mastectomy. A major determinant of DR was new or recurrent cancer, while psychosocial characteristics including depression, distress, and negative body image increased the likelihood of DR. CONCLUSION: The available research is yet to provide a clear understanding of the many interrelated issues involved in DR. Given the consensus that presurgical information was inadequate, making standardised educational material more widely available and increasing use of breast care nurses in preoperative patient education roles may be useful.

Patient-reported outcomes of breast reconstruction in older women: Audit of a large metropolitan public/private practice in Sydney, Australia.

OBJECTIVE: Older age is associated with lower rates of breast reconstruction (BR) for women requiring mastectomy. This study compared patient-reported outcomes between women aged 60 years and older who had received mastectomy and BR with those who received no BR (NBR). METHODS: About 135 women aged 60 or over treated between 2009 and 2016 with mastectomy only (N = 87) or mastectomy with BR (N = 48) for primary breast cancer completed patient-reported outcome measures using a set of validated questionnaires. Reasons for choosing or declining BR were also explored using a set of nonvalidated questionnaires. RESULTS: Patients who received BR were generally younger (P = <0.001) and reported greater satisfaction with their bodies (P = 0.048) than NBR patients. Patients with autologous reconstruction reported greater satisfaction with their breasts than implant-based reconstruction patients. Both BR and NBR patients reported good quality of life, low pain scores, good body image, and low levels of decisional regret. CONCLUSIONS: These data do not identify any quality of life-related reasons to not offer clinically fit, well-informed older women the option of BR.

Women's expectations of breast reconstruction following mastectomy for breast cancer: a systematic review.

PURPOSE: Breast reconstruction (BR) makes an important positive contribution to the quality of life of many women who have undergone mastectomy for breast cancer. The purpose of this article is to evaluate the evidence for possible relationships between women's expectations of BR and their satisfaction with outcomes to inform and facilitate improved communication about BR options prior to initial surgery. METHODS: A systematic review of the literature reporting expectations of BR published between 1 January 1994 and 6 March 2017 identified 2107 initial search results. Twenty-one publications, reporting 20 studies (2288 participants), satisfied the selection criteria. Information on study aim and time frame, participation rate, design/methods, limitations/bias, results and conclusions, as well as participant clinical and demographic information, was reported. An overall quality score was generated for each study. RESULTS: Four of five studies that quantified expectations and satisfaction found a positive relationship between the two. This may indicate a possible trend, but as 16 of the 21 included publications did not provide quantifiable data, no firm conclusions are possible. CONCLUSION: Our findings have important implications for policy and practice which are applicable to medical decision-making more broadly. There is a clear need to utilise accurate and consistent measures of patient-reported expectations and to educate both patients and health practitioners about the importance of informed discussion about treatment options. This is particularly salient for women facing a choice about BR, a major breast cancer survivorship decision. Routine use of an expectations checklist in pre-operative consultations may be useful.

Making decisions about breast reconstruction: A systematic review of patient-reported factors influencing choice.

PURPOSE: Many studies have explored women's reasons for choosing or declining a particular type of breast reconstruction (BR) following mastectomy for breast cancer. This systematic review synthesises women's reasons for choosing a range of BR options, including no BR, in different settings and across time. METHODS: Thirteen databases were systematically searched, with 30 studies (4269 participants), meeting the selection criteria. Information on study aim and time frame, participation rate, design/methods, limitations/bias, reasons and conclusions, as well as participant clinical and demographic information, was reported. An overall quality score was generated for each study. Reasons were grouped into eight domains. RESULTS: While study methodology and results were heterogeneous, all reported reasons were covered by the eight domains: Feeling/looking normal; Feeling/looking good; Being practical; Influence of others; Relationship expectations; Fear; Timing; and Unnecessary. We found a strong consistency in reasons across studies, ranging from 52% of relevant publications citing relationship expectations as a reason for choosing BR, up to 91% citing fear as a reason for delaying or declining BR. Major thematic findings were a lack of adequate information about BR, lack of genuine choice for women and additional access limitations due to health system barriers. CONCLUSIONS: Understanding women's reasons for wanting or not wanting BR can assist clinicians to help women make choices most aligned with their individual values and needs. Our thematic findings have equity implications and illustrate the need for surgeons to discuss all clinically appropriate BR options with mastectomy patients, even if some options are not available locally.

An evaluation of factors affecting preference for immediate, delayed or no breast reconstruction in women with high-risk breast cancer.

OBJECTIVE: Women with locally advanced breast cancer face many conflicting issues affecting their choice of immediate versus delayed versus no breast reconstruction (BR). This single-centre pilot study assessed high-risk women's reasons and priorities in choosing the timing and type of BR in a setting where all clinically feasible options were discussed with all women. METHODS: Fifty-one women from a metropolitan breast oncology practice, who were likely to require post-mastectomy radiotherapy (PMRT), were recruited after making their decision about BR. Participants completed a questionnaire (69% preoperatively), adapted from Reaby (1998), evaluating the factors affecting their decision. Responses were subsequently classified into eight issue-based domains (feeling normal, feeling good, being practical, influence of others, expectations, fear, timing and unnecessary). Demographic and clinical data were also collected. RESULTS: There were 32 immediate BR (IBR = 63%), seven delayed BR (DBR = 13%) and 12 no BR (NBR = 23%). Analysis using the chi square test showed women over 60 were more likely to choose NBR (p = 0.005), while women living with a partner were more likely to choose IBR (p = 0.032). The most relevant domains for both IBR and DBR were 'feeling good' and 'feeling normal'; and for NBR were 'unnecessary' and 'being practical'. Although all women understood pre-operatively the potential aesthetic limitations of PMRT, 63% still chose IBR. CONCLUSIONS: These data will enable clinicians, researchers and women with breast cancer to gain a clearer understanding of the factors that impact on the choice and timing of BR in women requiring PMRT, a major breast cancer survivorship decision. Copyright © 2016 John Wiley & Sons, Ltd.

WHAT IS THE ROLE OF COMMUNITY PREFERENCE INFORMATION IN HEALTH TECHNOLOGY ASSESSMENT DECISION MAKING? A CASE STUDY OF COLORECTAL CANCER SCREENING.

OBJECTIVES: The aim of this study was to determine the role of community preference information from discrete choice studies of colorectal cancer (CRC) screening in health technology assessment (HTA) reports and subsequent policy decisions. METHODS: We undertook a systematic review of discrete choice studies of CRC screening. Included studies were reviewed to assess the policy context of the research. For those studies that cited a recent or pending review of CRC screening, further searches were undertaken to determine the extent to which community preference information was incorporated into the HTA decision-making process. RESULTS: Eight discrete choice studies that evaluated preferences for CRC screening were identified. Four of these studies referred to a national or local review of CRC screening in three countries: Australia, Canada, and the Netherlands. Our review of subsequently released health policy documents showed that while consideration was given to community views on CRC, policy was not informed by discrete choice evidence. CONCLUSIONS: Preferences and values of patients are increasingly being considered "evidence" to be incorporated into HTA reports. Discrete choice methodology is a rigorous quantitative method for eliciting preferences and while as a methodology it is growing in profile, it would appear that the results of such research are not being systematically translated or integrated into HTA reports. A formalized approach is needed to incorporate preference literature into the HTA decision-making process.

Colorectal cancer screening: why immunochemical fecal occult blood tests may be the best option.

BACKGROUND: There are many test options available for colorectal cancer screening. The choice of test relates to the objectives of those offering or considering screening. DISCUSSION: While all screening programs aim to detect disease early in order to improve the length and/or quality of life for the individual, some organizations and individuals prefer screening tests that offer the opportunity for cancer prevention. Others favor maximizing participation or the opportunity for shared decision-making, including discussion of information on test quality and availability. We propose three additional objectives for screening: minimizing harms, optimizing economic efficiency and maximizing equity of access to screening. SUMMARY: Applying these objectives to colorectal cancer screening, we advocate the use of immunochemical FOBTs as the preferred screening strategy, as it satisfies all three of these important objectives.

Costs and cost-effectiveness of full implementation of a biennial faecal occult blood test screening program for bowel cancer in Australia.

OBJECTIVE: To examine the costs and cost-effectiveness of full implementation of biennial bowel cancer screening for Australian residents aged 50-74 years. DESIGN AND SETTING: Identification of existing economic models from 1993 to 2010 through searches of PubMed and economic analysis databases, and by seeking expert advice; and additional modelling to determine the costs and cost-effectiveness of full implementation of biennial faecal occult blood test screening for the five million adults in Australia aged 50-74 years. MAIN OUTCOME MEASURES: Estimated number of deaths from bowel cancer prevented, costs, and cost-effectiveness (cost per life-year gained [LYG]) of biennial bowel cancer screening. RESULTS: We identified six relevant economic analyses, all of which found colorectal cancer (CRC) screening to be very cost-effective, with costs per LYG under $55,000 per year in 2010 Australian dollars. Based on our additional modelling, we conservatively estimate that full implementation of biennial screening for people aged 50-74 years would have gross costs of $150 million, reduce CRC mortality by 15%-25%, prevent 300-500 deaths from bowel cancer, and save 3600-6000 life-years annually, for an undiscounted cost per LYG of $25,000-$41,667, compared with no screening, and not taking cost savings as a result of treatment into consideration. The additional expenditure required, after accounting for reductions in CRC incidence, savings in CRC treatment costs, and existing ad-hoc colonoscopy use, is likely to be less than $50 million annually. CONCLUSIONS: Full implementation of biennial faecal occult blood test screening in Australia can reduce bowel cancer mortality, and is an efficient use of health resources that would require modest additional government investment.

On the frontiers of change: breast surgeons' views on demarcation between surgical sub-specialties in Australia.

BACKGROUND: The emergence of breast oncoplastic surgery provides women with more surgical options for improved aesthetics following breast-conserving surgery and for breast reconstruction (BR) following mastectomy. For some established breast and plastic surgeons, this development may be perceived as increasing competition for patients and raises the potential for demarcation issues between and within surgical sub-specialties. The objectives of the study were to document surgeons' views on demarcation between general/breast, oncoplastic/breast and plastic reconstructive breast surgeons in Australia, to examine the potential impact demarcation issues may have on informed patient choice and to recommend ways of reducing them. METHODS: In-depth qualitative interviews were conducted with a convenience sample of 31 (22 oncoplastic and nine plastic reconstructive) surgeons who performed BR. RESULTS: Descriptive analysis of the interviews revealed a range in the perceptions of the extent of demarcation. Six common themes were identified: oncoplastic techniques are unnecessary and potentially unsafe; reconstructive surgery should be left to 'the experts'; non-referral of patients for discussion of surgical options they do not offer; professional jealousy; workload capacity; and the old versus the new guard. Potential solutions suggested by the participants focused on improving relations between oncoplastic and plastic reconstructive surgeons and changes to breast surgical training. CONCLUSION: While most surgeons were optimistic about the current divide diminishing with time, a more pro-active stance is required if patient-centred care is to be improved. Roundtable discussions with a broad range of stakeholders are planned to begin this process.

Half a Century of Wilson & Jungner: Reflections on the Governance of Population Screening.

Background: In their landmark report on the "Principles and Practice of Screening for Disease" (1968), Wilson and Jungner noted that the practice of screening is just as important for securing beneficial outcomes and avoiding harms as the formulation of principles. Many jurisdictions have since established various kinds of "screening governance organizations" to provide oversight of screening practice. Yet to date there has been relatively little reflection on the nature and organization of screening governance itself, or on how different governance arrangements affect the way screening is implemented and perceived and the balance of benefits and harms it delivers. Methods: An international expert policy workshop convened by Sturdy, Miller and Hogarth. Results: While effective governance is essential to promote beneficial screening practices and avoid attendant harms, screening governance organizations face enduring challenges. These challenges are social and ethical as much as technical. Evidence-based adjudication of the benefits and harms of population screening must take account of factors that inform the production and interpretation of evidence, including the divergent professional, financial and personal commitments of stakeholders. Similarly, when planning and overseeing organized screening programs, screening governance organizations must persuade or compel multiple stakeholders to work together to a common end. Screening governance organizations in different jurisdictions vary widely in how they are constituted, how they relate to other interested organizations and actors, and what powers and authority they wield. Yet we know little about how these differences affect the way screening is implemented, and with what consequences. Conclusions: Systematic research into how screening governance is organized in different jurisdictions would facilitate policy learning to address enduring challenges. Even without such research, informal exchange and sharing of experiences between screening governance organizations can deliver invaluable insights into the social as well as the technical aspects of governance.

Evaluation of a structured clinical program and formal coursework in breast surgeon training in Australia and New Zealand.

INTRODUCTION: Breast surgeon training has been restructured since the inception of Breast Surgeons of Australia and New Zealand Inc. (BreastSurgANZ) in 2010. In 2016 a voluntary online course with a contemporary curriculum for breast surgery was initiated and taken up by the majority of post-fellowship trainees (PFTs). This article reports on PFT's perceptions of these major changes. METHODS: A 46-item online survey was sent to the 56 PFTs enrolled in 2015-2017. The survey canvassed PFT's views on aspects of the two-year training program, the Graduate Certificate in Breast Surgery (GCBS) and the role of BreastSurgANZ in training. RESULTS: 33/56 participants responded. The training program was rated positively with variation in satisfaction levels depending on operating experience and quality of training between clinical placements. The majority of respondents endorsed restricting numbers of training positions. GCBS students valued the clinical knowledge and structured format of the course. A range of diverse, often opposing, opinions were expressed on the appropriate role of BreastSurgANZ in training and accreditation. DISCUSSION: The dissonance caused by variability in training exposure and perceived mentor quality in different sites was the most important finding. The GCBS was well regarded by all students but time constraints and costs prevented some PFTs from undertaking the course. Standardisation of mandatory requirements for full BreastSurgANZ membership was identified as an issue for further consideration. CONCLUSION: This evaluation illuminates the challenges of providing consistently high quality breast surgical training. Many of the issues raised are being addressed by BreastSurgANZ.

Outcomes of breast reconstruction in older women: patterns of uptake and clinical outcomes in a large metropolitan practice.

BACKGROUND: Older age is associated with lower rates of breast reconstruction (BR) following mastectomy. This study compared a range of factors in women aged 60 years and older who had received mastectomy and BR with those who received no BR (NBR). METHODS: An audit of 338 women aged 60 or over treated with mastectomy with (n = 86) or without (n = 252) BR for primary breast cancer from 2009 to 2016 was conducted. Demographic, tumour, treatment, comorbidity and surgical complication data were obtained from patient medical records. RESULTS: NBR patients were associated with older age (P ≤ 0.001), more comorbidities (P = 0.038) and more extensive disease (P = 0.001) than BR patients. Total number of complications was not significantly different between BR and NBR patients (P = 0.286), or the different types of BR (P = 0.697). BR patients had higher rates of unplanned returns to the operating theatre, particularly in the late post-operative period (P = 0.025). Implant-based reconstruction was associated with more unplanned operating theatre returns than autologous reconstruction in the late post-operative period (P = 0.013). CONCLUSION: Post-mastectomy BR in elderly patients has a clinical complication profile similar to NBR patients. This audit found no clinical-based reasons to not offer oncologically suitable and clinically fit elderly women the option of BR.

Patterns of immediate breast reconstruction in New South Wales, Australia: a population-based study.

BACKGROUND: The rate of immediate breast reconstruction (IBR) following mastectomy for breast cancer in Australia is low and varies between regions. To date, no previous Australian studies have examined IBR rates between all hospitals within a particular jurisdiction, despite hospitals being an important known contributor to variation in IBR rates in other countries. METHODS: We used cross-classified random-effects logistic regression models to examine the inter-hospital variation in IBR rates by using data on 7961 women who underwent therapeutic mastectomy procedures in New South Wales (NSW) between January 2012 and June 2015. We derived IBR rates by patient-, residential neighbourhood- and hospital-related factors and investigated the underlying drivers for the variation in IBR. RESULTS: We estimated the mean IBR rate across all hospitals performing mastectomy to be 17.1% (95% Bayesian credible interval (CrI) 12.1-23.1%) and observed wide inter-hospital variation in IBR (variance 4.337, CrI 2.634-6.889). Older women, those born in Asian countries (odds ratio (OR) 0.5, CrI 0.4-0.6), residing in neighbourhoods with lower socioeconomic status (OR 0.7, CrI 0.5-0.8 for the most disadvantaged), and who underwent surgery in public hospitals (OR 0.4, CrI 0.1-1.0) were significantly less likely to have IBR. Women residing in non-metropolitan areas and attending non-metropolitan hospitals were significantly less likely to undergo IBR than their metropolitan counterparts attending metropolitan hospitals. CONCLUSION: Wide inter-hospital variation raises concerns about potential inequities in access to IBR services and unmet demand in certain areas of NSW. Explaining the underlying drivers for IBR variation is the first step in identifying policy solutions to redress the issue.

Low-Level Laser Treatment Is Ineffective for Capsular Contracture: Results of the LaTCon Randomized Controlled Trial.

BACKGROUND: Breast reconstruction with implants can be complicated by symptomatic capsular contracture, especially after radiotherapy. A phase I, nonrandomized clinical trial demonstrated improvement in capsular contracture and avoidance of revision surgery with low-level laser therapy. This phase II, double-blind, randomized controlled trial assessed the efficacy of low-level laser for treating capsular contracture in women with breast reconstruction following mastectomy for breast cancer. METHODS: Participants had completed their definitive implant-based reconstruction a minimum of 6 months previously and were randomized to weekly treatments over 6 weeks with either an active or inactive low-level laser handpiece (Riancorp LTU-904). Pain, tightness, arm movement, and appearance were assessed by patient questionnaires. Breast symmetry, shape, naturalness, softness, and grade of contracture were assessed by clinician reports. Participants were assessed at 1 and 6 months after completion of the treatments. RESULTS: A total of 42 patients (intervention arm, n = 20; placebo, n = 22) were assessed in the trial. Thirty-two had postmastectomy radiotherapy. There was no significant difference in the change in any patient-reported outcomes or clinician-reported outcomes of breast symmetry, shape, or naturalness for the two groups. There was a significantly greater improvement in clinician-reported breast softness (p < 0.05) and degree of contracture (p < 0.05) in the placebo group at both 1- and 6-month follow-up. CONCLUSION: Low-level laser is not an effective therapy for breast implant capsular contracture in reconstruction patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

From little things, big things grow: a local approach to system-wide maternity services reform in the absence of definitive evidence.

BACKGROUND: For nearly two decades calls have been made to expand the role of midwives within maternity services in Australia. Although some progress has been made, it has been slow and, at system-wide level, limited. There are many barriers that prevent the expansion of midwifery-led services in Australia including funding arrangements for midwifery care, a lack of political will and resistance from powerful medical interest groups. The ongoing debate that exists about the evidence for the safety of midwifery-led care, particularly for the intrapartum phase, is likely to be an important reason why policy-makers are reluctant to implement system-wide reforms of maternity services. DISCUSSION: Those opposed to the expansion of midwifery-led care argue that these services are only appropriate for low-risk women. They claim the evidence in support of midwifery-led care has too many holes in it to guarantee that services are safe for higher risk women. Midwifery advocates, however, argue there is no evidence to support the claim that midwifery-led services lead to poorer outcomes in any risk group. Despite this, funding for midwifery-led care outside hospitals remains limited. This article contends that calls for the system-wide expansion of midwifery-led care (such as through funding independently practising midwives) based on the available evidence are unlikely to succeed. There are too many methodological challenges in this area to ever "prove" that midwifery-led services are safe - except for the lowest risk women - and when there is doubt, policy-makers are likely to err on the side of caution. SUMMARY: In order to expand access to midwifery care, advocates should abandon the idea of system-wide reform for now. Instead, they should concentrate on implementing small-scale, locally based changes because it is at this grass roots level that health professionals can work together to resolve the major sticking points - accurately assessing risk, identifying when it changes and responding appropriately. While a lack of political will is a major obstacle to reform it is amenable to change. We argue that system-wide reform is most likely to occur when policy-makers can reference examples of successful locally-based midwifery-led programs across Australia.