Patients' perspectives on quality and patient safety failures: lessons learned from an inquiry into transvaginal mesh in Australia.

BACKGROUND: Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017. METHOD: We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure. RESULTS: Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms. CONCLUSION: We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.

Australian women's judgements about using artificial intelligence to read mammograms in breast cancer screening.

Objective: Mammographic screening for breast cancer is an early use case for artificial intelligence (AI) in healthcare. This is an active area of research, mostly focused on the development and evaluation of individual algorithms. A growing normative literature argues that AI systems should reflect human values, but it is unclear what this requires in specific AI implementation scenarios. Our objective was to understand women's values regarding the use of AI to read mammograms in breast cancer screening. Methods: We ran eight online discussion groups with a total of 50 women, focused on their expectations and normative judgements regarding the use of AI in breast screening. Results: Although women were positive about the potential of breast screening AI, they argued strongly that humans must remain as central actors in breast screening systems and consistently expressed high expectations of the performance of breast screening AI. Women expected clear lines of responsibility for decision-making, to be able to contest decisions, and for AI to perform equally well for all programme participants. Women often imagined both that AI might replace radiographers and that AI implementation might allow more women to be screened: screening programmes will need to communicate carefully about these issues. Conclusions: To meet women's expectations, screening programmes should delay implementation until there is strong evidence that the use of AI systems improves screening performance, should ensure that human expertise and responsibility remain central in screening programmes, and should avoid using AI in ways that exacerbate inequities.

Transvaginal mesh in Australia: An analysis of news media reporting from 1996 to 2021.

INTRODUCTION: Transvaginal mesh (mesh) surgeries have been used to treat stress urinary incontinence (incontinence) and/or pelvic organ prolapse (prolapse). In Australia, as in many other countries, the harms caused by mesh eventually prompted individual and collective attempts to achieve redress. The rise of mesh surgery as a procedure, the experience of mesh-affected women and the formal inquiries and legal actions that followed all occurred in social, cultural and discursive contexts. One strategy to understand these contexts is to track how the mesh and key actors in the mesh stories have been portrayed in mass media sources. We conducted a media analysis of the most highly read Australian newspapers and online news media platforms, focusing on how mesh and the interaction of stakeholders in mesh stories were presented to the Australian public. METHOD: We searched systematically in the top 10 most-read print and online media outlets in Australia. We included all articles that mentioned mesh, from the date of first use of mesh in Australia to the date of our final search (1996-2021). RESULT: After early scant media reporting focusing on the benefits of mesh procedures, major Australian medicolegal processes created a hook to shift reporting about mesh. The news media then played a significant role in redressing women's experienced epistemic injustice, including by amplifying previously ignored evidence of harm. This created an opportunity for previously unreported suffering to be revealed to powerful actors, in settings beyond the immediate control and epistemic authority of healthcare stakeholders, validating women's testimony and creating new hermeneutic resources for understanding mesh. Over time, media reports show healthcare stakeholders responding sympathetically to these new understandings in public discourse, contrasting with their statements in earlier media coverage. CONCLUSION: We argue that mass media reporting, in synergy with medicolegal actions and the Australian Senate Inquiry, appears to have provided women with greater epistemic justice, giving their testimony privileged epistemic status such that it was considered by powerful actors. Although medical reporting is not recognised in the hierarchy of evidence embedded in the medical knowledge system, in this case, media reporting appears to have contributed to shaping medical knowledge in significant ways. PATIENT OR PUBLIC CONTRIBUTION: We used publicly available data, print and online media outlets, for our analysis. Therefore, this manuscript does not contain the direct contribution of patients, service users, caregivers, people with lived experience or members of the public.

Women's Experiences of and Perspectives on Transvaginal Mesh Surgery for Stress Urine Incontinency and Pelvic Organ Prolapse: A Qualitative Systematic Review.

BACKGROUND: Trans Vaginal Mesh (TVM) surgeries have been used to treat stress urine incontinency (SUI) and/or pelvic organ prolapse (POP). Systematic reviews of clinical studies of outcomes suggest that the procedures have benefited a majority of women, while noting that a small minority of women have experienced harms. To provide a more complete picture of outcomes, we conducted a systematic review of the qualitative literature to provide a comprehensive analysis of women's own accounts of their experience. METHOD: We conducted a systematic review and thematic synthesis of the evidence from the international qualitative literature on women's experiences of and perspectives on TVM surgery for SUI and/or POP between 1996 and 2020. We retrieved 6587 papers from PubMed, Cochrane, CINAHL, PsycINFO, Scopus, and Sociological Abstracts. After application of inclusion and exclusion criteria and full-text review of eligible articles, five articles were included in our systematic review. RESULTS: Findings from included articles were organised under three main themes: women's everyday lives were transformed by TVM surgery; women's expectations of and approach to their future lives; and women's critiques of TVM surgery. The transformation of women's everyday lives included a struggle to obtain recognition and support for their injuries before and after corrective surgery, ongoing limitations on their social, professional and personal lives, and compounding medical and psychological trauma as a result. Women's approaches to their future lives changed because of this transformation; we identified five main approaches, four were ways of accommodating change, a fifth involved being unable to accommodate life changes. Women's critiques included that TVM surgeries were overused, consent processes were poor, and surgeons' definitions of success were deficient. Women expressed concerns about the safety of TVM products and future risks of further complications and discussed multiple system failures in the health care they received. CONCLUSION: This review suggests that discounting women's experiences has caused compound trauma and skewed the clinical evidence base; while harms occurred in a minority of women, we suggest they should be recognised as an ethically significant potential outcome. Approaches to TVM injury should attend to historical epistemic injustice and recognise women's agency.

Terminology Change for Small Low-Risk Papillary Thyroid Cancer As a Response to Overtreatment: Results from Three Australian Community Juries.

Background: The majority of small papillary thyroid cancers (sPTCs) are treated surgically, rather than by active surveillance. Patient and clinician preference for surgery may be partially driven by the use of cancer terminology. Some experts propose that changing terminology would better communicate the indolent nature of sPTCs and improve uptake of active surveillance. Others argue that terminology that includes "cancer" correctly reflects the biological nature of these tumors. The views of informed lay publics can provide value-based perspectives on complex issues and guide policy discussions. Methods: We recruited 40 people for three community juries, held in Sydney, Wodonga, and Cairns, Australia. Participants were of diverse backgrounds and ages, recruited through random digit dialing and a topic-blinded social media strategy. Juries were informed about thyroid cancer, overdiagnosis, and overtreatment, and heard arguments for and against terminology change before deliberation. The deliberative process in Jury 1 led to a refinement of jury charge, the updated version that was then used in Juries 2 and 3. Results: Jury 1 favored no terminology change, and Juries 2 and 3 were divided on the topic. Key reasons for opposing terminology change included a strong desire to retain terminology that aligns with the pathological definition of cancer, and to avoid even a minimal risk of harm that could arise if patients became complacent in follow-up. Key reasons to support terminology change included a desire to reduce psychological distress, stigma, and discrimination associated with a cancer diagnosis, and an argument that terminology change may be a more effective trigger for health system reform compared with other options. The juries unanimously recommended community education and health system reforms to reduce harms of overtreatment, and expressed an expectation that clinicians and researchers reach agreement on clinical guidelines to promote better uptake of active surveillance. Conclusions: The conceptual tension between a pathological and an outcome-based understanding of cancer was apparent in deliberation. This highlights an ongoing challenge for those advocating changing disease terminology. Regardless of action on terminology, jurors shared a strong expectation that practical changes would be made to respond to the harms of overtreatment.

Perspectives of Vietnamese, Sudanese and South Sudanese immigrants on targeting migrant communities for latent tuberculosis screening and treatment in low-incidence settings: A report on two Victorian community panels.

BACKGROUND: Tuberculosis (TB) elimination strategies in Australia require a focus on groups who are at highest risk of TB infection, such as immigrants from high-burden settings. Understanding attitudes to different strategies for latent TB infection (LTBI) screening and treatment is an important element of justifiable elimination strategies. METHOD: Two community panels were conducted in Melbourne with members of the Vietnamese (n = 11), Sudanese and South Sudanese communities (n = 9). Panellists were provided with expert information about LTBI and different screening and health communication strategies, then deliberated on how best to pursue TB elimination in Australia. FINDINGS: Both panels unanimously preferred LTBI screening to occur pre-migration rather than in Australia. Participants were concerned that post-migration screening would reach fewer migrants, noted that conducting LTBI screening in Australia could stigmatize participants and that poor awareness of LTBI would hamper participation. If targeted screening was to occur in Australia, the Vietnamese panel preferred 'place-based' communication strategies, whereas the Sudanese and South Sudanese panel emphasized that community leaders should lead communication strategies to minimize stigma. Both groups emphasized the importance of maintaining community trust in Australian health service providers, and the need to ensure targeting did not undermine this trust. CONCLUSION: Pre-migration screening was preferred. If post-migration screening is necessary, the potential for stigma should be reduced, benefit and risk profile clearly explained and culturally appropriate communication strategies employed. Cultural attitudes to health providers, personal health management and broader social vulnerabilities of targeted groups need to be considered in the design of screening programs.

Insights into culturally appropriate latent tuberculosis infection (LTBI) screening in NSW: perspectives of Indian and Pakistani migrants.

OBJECTIVE: Latent tuberculosis (LTBI) case-finding and treatment are a focus of TB elimination in Australia. We sought the perspectives of migrants from two high-burden countries likely to be targeted by this strategy. METHODS: To understand perceptions of migrant groups in Australia on LTBI screening, 28 in-depth interviews were conducted with Indian and Pakistani community members recruited purposively through local organisations in the Illawarra region, New South Wales. Drawing on local TB policy, data collected qualitatively was analysed using framework methodologies. RESULTS: Australia's immigration system prioritises migrants of higher socioeconomic status. Participants supported elimination but perceived TB as a disease of the poor and not relevant to them. Lack of understanding of LTBI and sensitivity to being 'targeted' are further barriers to screening participation. CONCLUSION: Information provision and targeting rationale are an essential preamble to LTBI screening. Migration appears to modify cultural attitudes to TB, but not significantly. Despite less stigma surrounding TB in Australian contexts, testing privacy and confidentiality, and limiting public identification of specific groups remain important to program acceptability. Implications for public health: Progress towards TB elimination can be enhanced by consulting with targeted communities, using existing networks for communication and service provision; emphasising prevention benefits.

Ending TB in Australia: Organizational challenges for regional tuberculosis programs.

The World Health Organization's End TB Strategy aims to eliminate tuberculosis (TB) by 2050. Low-burden countries such as Australia are targeted for early elimination (2035), which will require an increase in the intensity and scope of case finding and treatment of people with latent TB infection (LTBI). Because 80 % of TB disease in Australia occurs in metropolitan Sydney (New South Wales) and Melbourne (Victoria), the commitment to move towards elimination has major implications for TB programs in these jurisdictions. We report on a case study analysis that compares and contrasts key attributes of each of these healthcare organizations. Such analysis has important implications for all countries seeking to implement international agreements within local health structures. Differences in the organizational structure, culture and systems of care in NSW and Victoria may facilitate or create barriers to changes in organizational system functions, especially the way in which TB prevention and LTBI treatment is delivered. Ratification of global health treaties and the development of national strategies, alone, is insufficient for realizing the promised outcomes. Even in high income countries, global health agendas such as TB elimination can be complicated by differences in local system structure and funding. As the timelines tighten towards 2035, more work must be done to identify the organizational conditions and service models that will facilitate progress towards TB elimination.

Should women aged 70-74 be invited to participate in screening mammography? A report on two Australian community juries.

OBJECTIVE: To elicit informed views from Australian women aged 70-74 regarding the acceptability of ceasing to invite women their age to participate in government-funded mammography screening (BreastScreen). DESIGN: Two community juries held in 2017. SETTING: Greater Sydney, a metropolis of 4.5 million people in New South Wales, Australia. PARTICIPANTS: 34 women aged 70-74 with no personal history of breast cancer, recruited by random digit dialling and previously randomly recruited list-based samples. MAIN OUTCOMES AND MEASURES: Jury verdict and rationale in response to structured questions. We transcribed audio-recorded jury proceedings and identified central reasons for the jury's decision. RESULTS: The women's average age was 71.5 years. Participants were of diverse sociocultural backgrounds, with the sample designed to include women of lower levels of educational attainment. Both juries concluded by majority verdict (16-2 and 10-6) that BreastScreen should continue to send invitations and promote screening to their age group. Reasons given for the majority position include: (1) sending the invitations shows that society still cares about older women, empowers them to access preventive health services and recognises increasing and varied life expectancy; (2) screening provides women with information that enables choice and (3) if experts cannot agree, the conservative approach is to maintain the status quo until the evidence is clear. Reasons for the minority position were the potential for harms through overdiagnosis and misallocation of scarce health resources. CONCLUSIONS: Preventive programmes such as mammography screening are likely to have significant symbolic value once they are socially embedded. Arguments for programme de-implementation emphasising declining benefit because of limited life expectancy and the risks of overdiagnosis seem unlikely to resonate with healthy older women. In situations where there is no consensus among experts on the value of established screening programmes, people may strongly prefer receiving information about their health and having the opportunity make their own choices.

Eliminating latent tuberculosis in low-burden settings: are the principal beneficiaries to be disadvantaged groups or the broader population?

Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide, and the burdens of this disease continue to track prior disadvantage. In order to galvanise a coordinated global response, WHO has recently launched the End TB Campaign that aims to eliminate TB by 2050. Key to this is the introduction of population screening programmes in low-burden settings to identify and treat people who have latent TB infection (LTBI). The defining features of LTBI are: that it is not an active disease but confers an increased risk of disease; the socially disadvantaged are those most in danger and uncertainty persists as to who will be harmed or benefitted from screening-led prophylactic interventions. Systematic screening programmes that include surveillance, case-finding and treatment of asymptomatic individuals inevitably redistribute the risk of harms and the potential for benefits within a population. The extent to which those targeted within such programmes should be exposed to higher levels of risk in the pursuit of individual or community benefits requires careful consideration prior to implementation. As currently construed, it remains unclear who stands to benefit most from how LTBI screening in high-income countries is being organised, and whose health is being prioritised: members of disadvantaged groups or the broader community. Unless the aims of LTBI screening programmes in these settings are made transparent and their prioritisation ethically justified, there is a significant danger that such a targeted intervention will further disadvantage those who have the least capacity to bear the burdens of TB elimination.

All care, but whose responsibility? Community juries reason about expert and patient responsibilities in prostate-specific antigen screening for prostate cancer.

General practitioners have implicitly been given responsibility for guiding men's decisions about prostate-specific antigen-based screening for prostate cancer, but patients' expectations of the bounds of this responsibility remain unclear. We sought to explore how well-informed members of the public allocate responsibilities in prostate-specific antigen screening decision-making. In 2014, we convened two Community juries in Sydney, Australia, to address questions related to the content and timing of information provision and respective roles of patients and general practitioners in screening decisions. Participants in the first jury were of mixed gender and of all ages (n = 15); the participants in the second jury were all male and of screening age (n = 12). Both juries were presented with balanced factual evidence on the harms and benefits of prostate-specific antigen screening and expert perspectives on ethico-legal aspects of consent in medical practice. In their deliberations, jurors agreed that general practitioners should take responsibility for informing men of the options, risks and benefits of prostate-specific antigen testing, but arrived at different positions on whether or not general practitioners should also guide screening decisions. Jurors also disagreed on how much and when general practitioners should provide detailed information about biopsies and treatments. These responses suggest that for prostate-specific antigen testing, there is a public expectation that both the allocation of responsibility between general practitioners and their male patients, and the level of information provided will be tailored to individual men. In the presence of expert uncertainty, a well-informed public may have reason to embrace or resist shared decision-making processes.

"What should happen before asymptomatic men decide whether or not to have a PSA test?" A report on three community juries.

OBJECTIVES: To elicit the views of well informed community members on the ethical obligations of general practitioners regarding prostate-specific antigen (PSA) testing, and what should be required before a man undergoes a PSA test. DESIGN AND SETTING: Three community juries held at the University of Sydney over 6 months in 2014. PARTICIPANTS: Forty participants from New South Wales, of diverse social and cultural backgrounds and with no experience of prostate cancer, recruited through public advertising: two juries of mixed gender and ages; one all-male jury of PSA screening age. RESULTS: In contrast to Royal Australian College of General Practitioners guidelines, the three juries concluded that GPs should initiate discussions about PSA testing with asymptomatic men over 50 years of age. The mixed juries voted for GPs offering detailed information about all potential consequent benefits and harms before PSA testing, and favoured a cooling-off period before undertaking the test. The all-male jury recommended a staggered approach to providing information. They recommended that written information be available to those who wanted it, but eight of the 12 jurors thought that doctors should discuss the benefits and harms of biopsy and treatment only after a man had received an elevated PSA test result. CONCLUSIONS: Informed jury participants preferred that GPs actively supported individual men in making decisions about PSA testing, and that they allowed a cooling-off period before testing. However, men of screening age argued that uncertain and detailed information should be communicated only after receiving an elevated PSA test result.

Testing relationships: ethical arguments for screening for type 2 diabetes mellitus with HbA1C.

Since the 1990s, glycated haemoglobin (HbA1C) has been the gold standard for monitoring glycaemic control in people diagnosed as having either type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Discussions are underway about diagnosing diabetes mellitus on the basis of HbA1C titres and using HbA1C tests to screen for T2DM. These discussions have focused on the relative benefits for individual patients, with some attention directed towards reduced costs to healthcare systems and benefits to society. We argue that there are strong ethical reasons for adopting HbA1C-based diagnosis and T2DM screening that have not yet been articulated. The rationale includes the differential impact of HbA1C-based diabetic testing on disadvantaged groups, and what we are beginning to learn about HbA1C vis-à-vis population health. Although it is arguable that screening must primarily benefit the individual, using HbA1C to diagnose and screen for T2DM may promote a more just distribution of health resources and lead to advances in investigating, monitoring and tackling the social determinants of health.

Hemoglobin A1c as a diagnostic tool: public health implications from an actor-network perspective.

Public health arguments for collecting hemoglobin A1c (HbA1c) data, particularly in clinical settings, should be reframed to place more emphasis on nonmedical determinants of population health. We compare individual- with population-level interpretations of HbA1c titers. This comparison reveals that public health researchers need to pay close attention to diagnostic tests and their uses, including rhetorical uses. We also synthesize historical and current evidence to map out 2 possible scenarios for the future. In the first scenario, prevention efforts emphasize primary care and focus almost entirely downstream. The second scenario anticipates downstream interventions but also upstream interventions targeting environments. Our analysis adapts actor-network theory to strategic planning and forecasting in public health.

Fractured hips: surgical authority, futility and innovation in nineteenth century medicine.

Orthopaedists have long found hip fractures to be a significant source of clinical uncertainty and professional disagreement. For much of the nineteenth century, surgeons were happy to follow Sir Astley Cooper's directive to 'treat the patient and let the fracture go'. Most sufferers were elderly, near the end of their lives and at significant risk from morbid complications. This palliative posture was further justified by a substantial corpus of medical evidence. Any attempt at therapeutic innovation was unwarranted because clinical experience, post-mortem studies and animal experiments indicated that fractures within the hip joint never healed. Yet as there were isolated cases of intra-capsular healing, surgeons such as Nicholas Senn began to contest this evidence. To his consternation, as he tried to demonstrate the possibility of restorative treatments, Senn found the fundamental problem with hip fractures was that the empiricism of current clinical methods created and perpetuated their own therapeutic justifications.

Picturing the pain of animal others: rationalising form, function and suffering in veterinary orthopaedics.

Advances in veterinary orthopaedics are assessed on their ability to improve the function and wellbeing of animal patients. And yet historically veterinarians have struggled to bridge the divide between an animal's physicality and its interior experience of its function in clinical settings. For much of the twentieth century, most practitioners were agnostic to the possibility of animal mentation and its implications for suffering. This attitude has changed as veterinarians adapted to technological innovations and the emergence of a clientele who claimed to understand and relate to the subjective experiences of their animals. While visualising technologies and human analogies have shaped the nuts and bolts of veterinary orthopaedic practices, an emerging awareness of the inability of radiographic images to apprehend or correlate to a patient's experience of their function reliably has required veterinarians to place a greater emphasis on the owner's knowledge of the "selves" inhabiting their animals. Rather than simply basing clinical judgments on the "look" of their patients, the indeterminacy in the connection between form and function has compelled veterinarians to put questions regarding particular human-animal relationships near the centre of their practices, not least in orthopaedic surgery.