Factors affecting women's decision between uterine-preserving versus hysterectomy-based surgery for pelvic organ prolapse.

BACKGROUND: Given the prevalence of women seeking surgical treatment for pelvic organ prolapse (POP), there is a need to understand women's decision-making regarding uterine-preserving versus hysterectomy-based surgeries. Historically, hysterectomy-based surgeries have been the preferred treatment for pelvic organ prolapse; however, contemporary evidence supports uterine-preserving surgeries as equivalent. At present, the lack of information available to the general public and limited options presented at surgical consultation for pelvic organ prolapse may hinder women's autonomy as they navigate surgical treatment. OBJECTIVES: To examine the factors affecting women's decision-making processes regarding uterine-preserving or hysterectomy-based surgery for pelvic organ prolapse. DESIGN: This is a qualitative study. METHODS: We conducted semi-structured, qualitative interviews with women seeking surgery for pelvic organ prolapse to explore the factors affecting women's decision-making between hysterectomy-based and uterine-preserving surgeries. RESULTS: Women (n = 26) used clinical and personal factors to determine which surgery was best. Women noted that the lack of evidence (clinical and/or anecdotal) available to them hindered their decision-making, causing them to rely more on their own interpretations of the evidence, what they perceived to be "normal," and what their surgeon recommended. Even with standardized discussion regarding the existing clinical equipoise between surgeries at the clinical consultation, some women still had misperceptions that hysterectomy-based surgery would convey the lowest risk of prolapse recurrence and be best for severe prolapse. CONCLUSION: There is a need for more transparency in discussions about prolapse and the factors affecting women's decision-making for surgical repair of pelvic organ prolapse. Clinicians should be prepared to offer the option of hysterectomy-based or uterine-preserving surgeries and to clearly explain the clinical equipoise between these procedures.

The (commercialised) experience of operating: Embodied preferences, ambiguous variations and explaining widespread patient harm.

This article provides a detailed account of how surgeons perceived and used a device-procedure that caused widespread patient harm: transvaginal mesh for the treatment of pelvic floor disorders in women. Drawing from interviews with 27 surgeons in Canada, the UK, the United States and France and observations of major international medical conferences in North America and Europe between 2015 and 2018, we describe the commercially driven array of operative variations in the use of transvaginal mesh and show that surgeons' understanding of their hands-on, sensory experience with these variations is central to explaining patient harm. Surgeons often developed preferences for how to manage actual and anticipated dangers of transvaginal mesh procedures through embodied operative adjustments, but collectively the meaning of these preferences was fragmented, contested and deferred. We critically reflect on surgeons' understandings of their operative experience, including the view that such experience is not evidence. The harm in this case poses a challenge to some ways of thinking about uncertainty and errors in medical sociology, and calls for attention to a specific feature of surgical work: the extent and persistence of operative practices that elude classification as right or wrong but are still most certainly better and worse.

A qualitative study of the impact of the COVID-19 pandemic on women seeking pelvic organ prolapse surgery in Alberta, Canada.

In addition to altering public infrastructure and social patterning, the COVID-19 pandemic has delayed many pelvic organ prolapse (POP) surgeries. POP-related stigma, symptomology and the experience of waiting for POP surgery can negatively impact women's quality of life and mental health. The experience of preoperative POP patients during the pandemic thus entails a new intersection of gendered, stigmatic and medical realities. Qualitative interviews were conducted with 26 preoperative POP patients as part of a larger qualitative study, 20 of whom spontaneously volunteered information about how the pandemic coloured their experience living with and awaiting surgery for POP. Interviews occurred between January and July 2021, which coincided with the second and third waves of the pandemic in Alberta, Canada, and before full immunisation was available for all Albertans. Pandemic-related interview excerpts were thematically analysed, and four main findings emerged. (1) Though surgical delay meant living with unpleasant symptoms for longer than anticipated, some sought this out in order to protect vulnerable loved ones from possible hospital-acquired infection, (2) shifting and unclear hospital policies and logistics resulted in intense preoperative stress, at times causing women to temporarily cease treatment, (3) decreased access to public restroom infrastructure caused women to reduce their outings and (4) the imperative to minimise social gatherings made it easier for women to engage in POP-related, shame-based self-isolation without the notice of friends and family. As they can influence postoperative outcomes and treatment adherence, trends observed should be of interest to clinicians and policymakers alike.

"Broken"-How Identities as Women, Mothers and Partners Are Intertwined with the Experience of Living with and Seeking Treatment for Pelvic Organ Prolapse.

Pelvic Organ Prolapse (POP) occurs when one or more pelvic organs descend into or through the vaginal opening, significantly impacting physical and mental health. POP affects the female reproductive tract and, overwhelmingly, people who identify as women. However, little research has examined the impact of gendered expectations on women's treatment-seeking for POP and their decision-making around surgery for POP. To address this gap, we conducted semi-structured interviews with 26 women seeking surgery for POP in Alberta, Canada. Data were analyzed from a gender-based lens, using the Framework Method. Participants reported the need to balance their identities as women, partners, and mothers in their pursuit of treatment and faced many barriers to treatment related to their gendered responsibilities. Findings highlight the gendered experiences of prolapse in the context of healthcare needs and can inform policies and practices which promote more equitable access to prolapse treatment.

From anatomy to patient experience in pelvic floor surgery: Mindlines, evidence, responsibility, and transvaginal mesh.

Beginning in the late 1990s, surgeons around the world widely adopted the transvaginal placement of permanent synthetic mesh for the treatment of several common pelvic floor disorders in women. By 2012 it had become the subject of extensive litigation, including one of the biggest mass-tort cases in U.S. history, with litigants reporting debilitating and unexpected complications. Based on qualitative research that includes interviews with surgeons, observations of medical conferences, and analysis of archival materials, we argue the adoption of transvaginal mesh cannot be fully explained without recognizing the role of mindlines, or collective moral-epistemological ways of knowing and acting responsibly. The adoption of mesh was anchored in a mindline focused on repairing anatomy. The harms that resulted from transvaginal mesh necessitated a shift to a focus on patient experience. We analyze the role of evidence-based medicine (EBM) in the re-organization of these surgeons' mindlines, showing that mindlines are not reducible to evidence as defined by EBM and that evidence thus defined facilitated the adoption of transvaginal mesh.

Towards 'smart cities' as 'healthy cities': health equity in a digital age.

The advent of 'smart' technologies has already transformed urban life, with important consequences for physical, mental, and social well-being. Population health and equity have, however, been conspicuously absent from much of the 'smart cities' research and policy agenda. With this in mind, we argue for a re-conceptualization of 'digital divides' in terms of socio-economic gradients at the individual level, and we draw attention to digitally mediated connections as crucial elements for health promotion at an institutional level and for remedying inequities. We do so in part by reporting on a recent symposium. Overall, we begin to integrate the 'healthy cities' tradition with the current interest in 'smart cities'.

Formats of responsibility: elective surgery in the era of evidence-based medicine.

This article illustrates what pragmatic sociology refers to as investments in form, by examining the formats created and used by a group of surgeons to determine when elective surgery for pelvic floor disorders could be responsibly undertaken. Drawing upon ethnographic observations of surgical consultations at an academic medical centre in Canada, we show how two specific formats - that the patient is sufficiently bothered and the patient accepts the risks of surgery - allow for justifiable action in conditions of uncertainty and contingency and in light of the demands of dominant imperatives in medicine and health care, especially evidence-based medicine (EBM). We argue that an analytic of justification is necessary for understanding when and how surgery is offered and elected for, and for considering how surgical consultations might be improved.

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices.

BACKGROUND: Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting. METHODS: Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions. RESULTS: Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes. CONCLUSIONS: There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.

Multiple constraints compromise decision-making about implantable medical devices for individual patients: qualitative interviews with physicians.

BACKGROUND: Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options. METHODS: A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. RESULTS: Twenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications. CONCLUSIONS: This study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.

MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015.

OBJECTIVES: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace. METHODS: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm). RESULTS: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada. CONCLUSIONS: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians.

OBJECTIVE: Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions. DESIGN: Qualitative interviews using a basic descriptive approach. SETTING: Canada. PARTICIPANTS: Practicing cardiovascular and orthopaedic physicians. MAIN OUTCOME MEASURES: Level, processes and determinants of PE in medical device discussions and decisions. RESULTS: Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice. CONCLUSIONS: This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

OBJECTIVES: Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. DESIGN: A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. RESULTS: Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. CONCLUSIONS: Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

INTRODUCTION: Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. METHODS: A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. RESULTS: A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). CONCLUSIONS: Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.

BACKGROUND: Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices. METHODS: Qualitative methods were used for sampling, data collection and analysis. Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies. These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system, and research needed to achieve such a system. RESULTS: Consultations were held with 37 participants, and 47 participants attended the 1-day meeting. They recommended a multicomponent system including reporting by facilities, clinicians and patients, supported with some external surveillance for validation and real-time trials for high-risk devices. Many considerations were identified that constitute desirable characteristics of, and means by which to implement such a system. An overarching network was envisioned to broker linkages, establish a shared minimum dataset, and support communication and decision making. Numerous research questions were identified, which could be pursued in tandem with phased implementation of the system. DISCUSSION: These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery.

BACKGROUND: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures. METHODS/DESIGN: Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study: Stakeholders--federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included. Ethics--beneficence, non-maleficence, autonomy, justice. Economics--scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material. DISCUSSION: The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.