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Medicolegal, infrastructural, and financial aspects in gynecologic cancer surgery and their implications in decision making processes: Quo Vadis?
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  1. Emma Allanson1,
  2. Anjali Hari2,
  3. Edgard Ndaboine3,
  4. Paul A Cohen1 and
  5. Robert Bristow2
    1. 1 Division of Obstetrics and Gynaecology, Medical School, The University of Western Australia, Perth, Western Australia, Australia
    2. 2 Division of Gynecologic Oncology, University of California Irvine, Orange, California, USA
    3. 3 Department of Obstetrics & Gynecology, Catholic University of Health and Allied Sciences, Mwanza, Mwanza, Tanzania
    1. Correspondence to Professor Paul A Cohen, Division of Obstetrics and Gynaecology, Medical School, The University of Western Australia, Perth, WA 6009, Australia; paul.cohen{at}uwa.edu.au

    Abstract

    Surgical decision making is complex and involves a combination of analytic, intuitive, and cognitive processes. Medicolegal, infrastructural, and financial factors may influence these processes depending on the context and setting, but to what extent can they influence surgical decision making in gynecologic oncology? This scoping review evaluates existing literature related to medicolegal, infrastructural, and financial aspects of gynecologic cancer surgery and their implications in surgical decision making. Our objective was to summarize the findings and limitations of published research, identify gaps in the literature, and make recommendations for future research to inform policy.

    • Gynecologic Surgical Procedures

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    Introduction

    ‘Quo Vadis’—where are we going? The specialty of gynecologic oncology was recognized as a sub-specialty of obstetrics and gynecology in the USA in 1973.1 Now in our 50th year, it is appropriate to reflect on where we might be going and what opportunities exist for us to drive the specialty forward to improve outcomes for all who are affected by gynecologic cancers.

    Surgical decision making is complex, nuanced, and involves a combination of intuitive, sub-conscious, analytical, and conscious cognitive processes. Medicolegal, financial, and infrastructural factors influence surgical decision making but cannot be considered in isolation both for individual patients and at a departmental/institutional level. Crebbin et al suggest that surgical decision making can be considered under the headings of ‘preparing for a procedure’ and ‘monitoring the progress of a procedure’,2 and the current article addresses medicolegal, infrastructural, and financial aspects of gynecologic cancer surgery in these two scenarios.

    Medicolegal, infrastructural, and financial factors vary substantially within and between jurisdictions, and between high income and low income settings. Outside of litigation related to individual cases, the multidisciplinary team, which forms the cornerstone of gynecologic oncology surgical decision making, is most subject to medicolegal considerations. Much of gynecologic oncology surgery is defined by the quality indicator of a multidisciplinary case discussion to guide surgical decision making,3 and the team that undertakes this case discussion may be subject to medicolegal constraints or consequences.4

    But to what extent do medicolegal, infrastructural, and financial factors influence surgical decision making in gynecologic oncology? Given the broad and exploratory nature of this question, we conducted a scoping review to evaluate existing literature related to these factors and their implications in surgical decision making. Our objective was to summarize the findings and limitations of published research, identify gaps in the literature, and make recommendations for future research to inform policy.

    Methods

    We undertook a scoping review to assess the literature and developed a search strategy within PubMed. Search terms for medicolegal aspects were structured around legal, malpractice, legislation, insurance, practice, behavior, and consent. Infrastructural search terms included infrastructure, built environment, facilities, hospitals, and equipment. The financial search strategy was built around finances, cost, and economics. The full search strategy is shown in Online supplemental file 1. The search was limited to all original research studies from 2000 onwards. Titles and abstracts were screened (EA) and potentially eligible full texts were screened for review. We excluded studies on pre-cancerous conditions, including risk reduction strategies for ovarian cancer, post-menopausal bleeding, and uterine fibroids potentially heralding a cancer diagnosis.

    Supplemental material

    The included papers were categorized into their relevant topic (medicolegal, financial, and infrastructural). One author reviewed the full texts for inclusion under each topic: medicolegal (PAC), infrastructural (AH), and financial (EA). The PRISMA chart is shown in Figure 1.

    Results

    Our search identified 1004 studies after duplicates were removed. Of these, 142 full-text studies were assessed for eligibility and 94 were included (Figure 1).

    Medicolegal

    No studies evaluating medicolegal factors and their impact on surgical decision making specifically in gynecologic oncology were included.

    Infrastructural

    High Resource Settings

    Centralization of Surgery

    Centralization of surgery has been adopted as the optimal model for oncologic care across several countries in Europe over the last 30 years.5 The benefits of centralization have been demonstrated in Sweden after a sweeping change resulted in all patients with ovarian cancer being referred to a tertiary care center where their case was reviewed by a multidisciplinary tumor board and a decision made whether to proceed with treatment at the specialized care center versus a regional center. The outcome following this change was immense—the rate of complete cytoreduction was significantly higher and the interval between surgery and chemotherapy was reduced. The 3-year survival rate was most impressive with an increase from 44% to 65% after centralization.6 In the USA, arguments for centralization have been made but, given the complexities that come with multiple insurance companies and multiple models of hospital systems as well as varying levels of high and low resource settings, this has not yet happened in ovarian cancer care. Evidence shows that hospitals with better adherence to and capacity to deliver care, however, have better outcomes.7–14 However, while the referral to high-volume or high-adherence centers may improve outcomes,15 there are many practical barriers to this strategy. There can be issues with transportation as it is more convenient to receive care locally. Many patients choose their hospital in the USA based on where their insurance is covered, so it may make access to ovarian cancer care more difficult if insurance companies do not play a role in covering treatment at a centralized tertiary care center. Lastly, there are many regions, even in developed countries, where there are no high-volume centers.7 16 A study from the UK showed that, despite centralization, there is still a disparity when it comes to access to debulking surgeries given limited infrastructural resources, operating theater time, intensive care unit capacity, surgical training, and diagnostic delays. This led to a nationwide audit by the British Gynecological Cancer Society (BGCS) to look further into these reasons and develop strategies to overcome them.5 In a study that explored international variation in treatment and survival, lack of healthcare system resources was identified as a significant barrier to clinicians accessing optimal treatment for patients with ovarian cancer. A shortage of operating room time, beds, and intensive care capacity have been suggested as reasons for the misuse of neoadjuvant chemotherapy in patients who are otherwise operable.17 18

    Multidisciplinary Teams

    Although surgery at a high-volume center is important, the availability of rescue surgery and multidisciplinary teams for complications is what truly contributes to improved mortality at hospitals.7 16 In a retrospective database review by Wright et al, improved survival at higher volume centers was not due to fewer complications but rather those at lower volume centers were 50% more likely to die of their complication because of lack of access to adequate rescue surgery.19 This has been shown in general surgery, orthopedics, vascular surgery, and gynecologic oncology.20 Tertiary centers have more specialized surgeons across sub-specialities who are available to assist in managing complications—a key factor in post-operative cancer care in high resource settings. The multidisciplinary tumor board is also a key component of care that has become embedded in gynecologic oncology infrastructure, especially in high resource settings, which improves diagnosis and patient management.21 22 Both the European Society for Medical Oncology guidelines for management of gynecologic malignancies as well as the National Comprehensive Cancer Network guidelines call for the multidisciplinary discussion of cases when making treatment decisions.23 24

    Research, Trials, and Training

    High resource settings traditionally have fellowship training centers and access to clinical trials. Fellowship programs are important in order to establish the next generation of gynecologic oncologists and to increase the number of personnel who are trained in the most up-to-date surgical techniques. In our review, most papers regarding fellowship programs described minimally invasive surgical training curricula.25–28 In a study from 2011 looking at the European Network of Young Gynecologic Oncologists, representatives from 34 countries were asked a questionnaire about their training: 53% of European countries offered fellowships in gynecologic oncology and chemotherapy administration was taught in 70% of these programs; 41% of responders stated that they did not have access to minimally invasive techniques. This study called for the standardization of training across Europe.29 High resource settings support extensive research and clinical trials in gynecologic oncology which gives patients access to cutting-edge treatments and therapies. This in turn contributes to better outcomes including survival. However, even within high resource settings, there are disparities in enrolment in clinical trials.30 In the USA it has been found that individuals from diverse ethnic and racial groups who have the highest need for improvement in cancer care are the least represented in trials. A joint statement from the Gynecologic Oncology Group (GOG) and the Society of Gynecologic Oncology (SGO) mentioned pivotal trials that failed to enroll high numbers of populations who are most at risk of cancer-specific mortality. The authors suggested setting enrollment targets for under-represented racial and ethnic participants by considering incidence and mortality, addressing clinical sub-groups with attention to their molecular signatures, including the requirement to report race and ethnicity as well as publication of these data, and conducting monitoring during trial enrollment to proactively address any deficiencies in enrollment.30

    Low Resource Infrastructure

    Lack of Specialized Centers

    Low resource settings, primarily found in low and low to middle income countries (LMICs), face several challenges in providing adequate gynecologic oncology care due to limited resources and healthcare disparities. There is often a sparsity of dedicated centers to gynecologic oncology and patients often receive care in general hospitals and from generalists as well. In Tanzania, Ocean Road Cancer Institute, Bugando Medical Center, Kilimanjaro Christian Medical Center, and Arusha Lutheran Medical Center are among the few hospitals offering any form of cancer treatment services and not all of these sites offer radical surgery, chemotherapy, and radiation therapy.31 Given the increase in cancer incidence and mortality in sub-Saharan Africa, actions were recommended in a Commission published in Lancet Oncology in 2022. This paper cited many barriers to cancer care in sub-Saharan Africa and, although it commented on risk factors such as HIV and HPV prevalence, environmental exposures, and genetics, it also outlined infrastructural challenges. A summary of identified obstacles included lack of standardized documentation and practice, absence of a legal framework, insufficient training of healthcare staff, lack of cancer registries, and absence of diagnostics facilities. In order to create tertiary care centers that are specialized in gynecologic oncology surgery, more basic infrastructural issues have to be addressed first such as establishing training programs, cancer registries, ethical research standards, and guidelines for gynecologic oncology care.32 One solution that has been offered for the lack of specialty centers and therefore lack of multidisciplinary teams is the establishment of international tumor boards. Project ECHO, which has been described by Ngwa et al, brings together multidisciplinary teams from high and low middle income countries in which participants use videoconferencing to discuss patient cases in a tumor board. This is a space where specialists can share their expertise and provide mentorship to providers in LMICs who may be alone in practice or not fellowship trained.33

    Lack of Fellowship Training and Clinical Trials

    In many low resource settings there are more mid-level providers and a lack of fellowship-trained gynecologic oncologists. This further extends to sub-specialties surrounding gynecologic oncology such as gynecologic pathology, radiation oncology, medical oncology, and palliative care.34 For example, the doctor to patient ratio in Tanzania is 0.02 per 1000 and the hospital bed density is 0.7 beds per 10 000 population.31 However, the call for an increase in fellowship-trained gynecologic oncologists in LMICs is challenging. Many countries do not have senior gynecologic oncologists who are available to lead training and there is also a limited hospital infrastructure such as surgical equipment, blood, operating room time, pathology, imaging, or radiation oncology. Recognition of these barriers led to the development of the International Gynecologic Cancer Society (IGCS) Global Curriculum program that pairs academic gynecologic oncologists in high-income countries with experienced clinicians in LMICs to create structured gynecologic oncology fellowships.34 Other unique approaches to training also exist, as Bing et al described in a study in Zambia using low-cost virtual reality to upskill surgeons in radical hysterectomy.35

    Many clinical trials originate in Europe, Asia, and North America but not many have been established in Africa or certain countries in Central/South America. For certain disease processes such as cervical cancer where the global burden is highest in East Africa, it is essential to establish trials in the regions where the incidence and mortality are highest. Conclusions from a survey study conducted in Nigeria showed deficits in infrastructure for the establishment of clinical trials such as availability of pharmacists, standardized laboratory monitoring, and trained clinical trial personnel. The authors suggested partnerships between institutes in high income countries to provide funding and mentorship to those in LMICs.36 The National Institute of Health now offers grants for cancer center capacity building in LMICs which may be an avenue for such partnerships.

    Shortage of Medications and Blood

    Certain chemotherapeutic agents that are available in higher resource settings are not available in all LMIC hospitals. The World Health Organization publishes an essential medications list every year and drugs such as pembrolizumab, lenvatinib, olaparib and other poly (ADP-ribose) polymerase inhibitors and even bevacizumab were not listed as essential.37 Blood is another basic resource that is not always available in large quantities in low resource settings. This is likely due to low blood donation rates and lack of an organized and safe blood banking system. In a cross-sectional survey exploring LMIC hospital blood banking systems that spanned 27 LMICs, most hospitals relied on generating blood products within their own institution, delays in blood transfusion were common (57%), and there was a lack of physician education in terms of transfusion-related events (28%). Blood transfusion availability is essential for providing comprehensive cancer care and safe surgery and these data call for improving blood banking in these low resource centers.38

    Financial

    Ovarian Cancer

    Ovarian cancer is ideally treated at a high-volume specialist center staffed by trained gynecologic oncology surgeons. It is a disease for which the care needed spans months to years, and for which the care is costly to deliver. Bercow et al showed that, in the USA, the average cost of the first 12 months of care in ovarian cancer is 100 000 dollars.39 Contextual health system structures and cost reimbursement may mean that the burden of advances in ovarian cancer surgery (eg, the use of hyperthermic intra-peritoneal chemotherapy) is placed on the patient or hospital system, although the longer term argument of improved quality-adjusted life years may make the upfront costs acceptable.40 41 Costs associated with high-volume centers are described as higher than for low-volume centers, which may also be a function of the nature of the surgery being performed at low-volume centers. Tanner et al call for cost-effective approaches to surgical care of ovarian cancer that do not compromise care; however, it is hard to envisage a scenario where cost is the driving factor in aggressive management of ovarian cancer.42

    In recent years there has been a shift towards an increasing use of neoadjuvant chemotherapy in advanced ovarian cancer.43 This approach is also shown to be cost saving when compared with primary debulking surgery. While aggressive cytoreduction may be associated with higher direct surgical/hospital costs, it may represent a more cost-effective approach when considered as a benefit per life year gained.44–47 An approach that may on the surface appear more expensive, but is potentially cost-effective for a unit, is to undertake diagnostic laparoscopy for all patients with ovarian cancer to triage them to primary surgery or neoadjuvant chemotherapy.48 49

    Endometrial Cancer

    Costs in surgical decision making cannot be considered as the dollar value of a defined event in isolation, given the consequences to the patient and the oncological outcomes of a particular decision. This is demonstrated in the cost-effectiveness analysis by Burg et al of no nodal dissection (and risk assessment based on uterine factors), sentinel nodal dissection, and full nodal dissection in low to intermediate risk endometrial cancer. While no nodal dissection at the time of surgery was clearly more cost-effective, the consequences of that decision and its impact on quality-adjusted life years meant that sentinel nodal dissection was actually the most cost-effective strategy.50 Similarly, Cohn and colleagues compared three approaches in endometrial cancer—surgical staging with lymphadenectomy, lymphadenectomy based only on uterine factors at intra-operative frozen section, and hysterectomy with no surgical staging—and found surgical staging to be the most cost-effective in that it reduced the use of adjuvant radiotherapy without influencing survival,51 and Clements et al found that full lymphadenectomy was more cost-effective than selective lymphadenectomy.52 In other studies, comprehensive lymph node dissection has not been shown to be beneficial in terms of either oncological outcome or cost when compared with no lymph node dissection,53–56 whereas sentinel node dissection is more cost-effective (both direct cost and in terms of quality-adjusted life years) than full node dissection.57

    Women with endometrial hyperplasia may be managed within gynecologic oncology units due to a risk of concurrent malignancy with this diagnosis. Lim et al show that offering these women sentinel lymph node biopsy is a costly strategy with little clinical benefit.58

    Increasing numbers of obese women with endometrial cancer pose an increased burden on long-term survivorship issues in this cancer group. Neff et al found that offering weight loss surgery to women with endometrial cancer and obesity is a cost-effective approach to improving quality-adjusted life years.59

    Cervical Cancer

    The costs of treating cervical cancer are not insignificant, and are borne unfairly by those settings least resourced to treat it.60 Where two options exist for treatment, and one of those is surgical, cost may play a factor in decision making. Lachance et al describe a cost benefit analysis of hysterectomy after chemoradiation for stage 1B2 cervical cancer compared with brachytherapy, with the surgical option representing a higher financial burden.61 In a similar vein, Bohn and colleagues show that primary chemoradiation appears more cost-effective and with lower mortality than open radical hysterectomy in the treatment of early stage cervical cancer for women with a body mass index >40 kg/m2.62

    As we move increasingly towards sentinel node dissection in cervical cancer, cost-effectiveness in terms of both direct costs and quality-adjusted life years is a consideration. However, it also needs to be oncologically acceptable, as shown by Brar et al in their study which found that sentinel lymph node biopsy using technetium-99 and blue dye with ultra-staging is the most cost-effective strategy in terms of both patient morbidity and oncological survival.63

    Vulvar Cancer

    The cost-effectiveness of sentinel node biopsy in vulvar cancer highlights the potential conflicts we face in gynecologic oncology surgery between cost, morbidity, and oncological outcome (survival). Sutton and colleagues demonstrate that, for presumed early (stage 1 and 2) vulvar cancer, a full inguinofemoral lymph node dissection is the most cost-effective and beneficial approach, where survival is the outcome that defines beneficial.64 Sentinel nodal dissection is, however, described by several studies as the most cost-effective approach when it comes to both treatment costs and patient morbidity.65 66 This outcome is similarly demonstrated in a 2013 systematic review and meta-analysis on the same topic.67 Sentinel lymph node biopsy requires the use of nuclear medicine for lymphoscintigraphy following injection of a radiotracer technetium-99. While more costly than intra-operative detection of the sentinel node without pre-operative use of lymphoscintigraphy, it remains a cost-effective approach assuming it increases the detection rate of the sentinel node.68

    A series of specific surgical decisions may be driven by costs/cost benefit. We know that adverse surgical events increase hospital costs, and implementing strategies to reduce these clearly has financial benefits, in addition to the obvious benefit to patients.69 70 Examples found in this review include the use of prophylactic negative pressure dressings on laparotomy sites to reduce wound complications and length of operative time contributing to venous thromboembolic risk.71 72 Enhanced recovery after surgery (ERAS) protocols include a series of intra-operative decisions (eg, avoiding use of drains) and, aside from improved patient outcomes, one may consider that the evidence for the use of ERAS includes its cost-effectiveness.73–76 As described by Harrison et al: “Enhanced recovery programs may be considered as high value in healthcare as they provide improved outcomes while lowering resource use”.76

    Unconscious Decision Making

    Surgeons may decide not to operate on patients with a high tumor burden and/or those with a poor performance status and multiple comorbidities because of conscious or unconscious concerns about being criticized and/or penalized due to higher re-admission rates and financial costs.77 Indeed, public disclosure of surgical results appears to have resulted in denial of surgical treatment to high-risk patients. This highlights the critical importance of the denominator in surgical outcome reporting because only including patients who undergo surgery and omitting those patients who are denied surgery may result in bias.

    Discussion

    The lack of published studies relating specifically to medicolegal aspects of gynecologic oncology surgery represents an important gap in knowledge and an area for future research.78 79 In healthcare “prevention is better than cure”, and this phrase also applies to medicolegal claims which are best managed by preventing them. Surgeons have a duty of care to their patients in deciding whether to undertake the case, a duty of care in deciding what procedures to perform, and a duty of care in the conduct of that surgery. A breach of any of these duties gives the patient a right of legal action for negligence. To establish negligence the patient must show that the damage would not have occurred but for the surgeon’s negligence or that the surgeon’s negligence contributed to or increased the risk of injury. If the claim is for non-disclosure, the patient must show that, had they been adequately informed, they would not have consented to the surgery. Failure to communicate may increase the risk of litigation. Oyebode evaluated the relationship between clinical errors and malpractice claims in a systematic review of non-randomized controlled trials in an inpatient hospital setting. A poor relationship with the clinician and patients feeling that they were not being kept informed predicted a higher likelihood of the patient resorting to litigation.80 Initiatives that have been shown to reduce complaints and negligence claims against physicians include risk management programs, communication and resolution programs, peer programs, and continuing professional development (CPD).81 Following the implementation of risk management programs, reduced rates of claims and complaints have consistently been observed. However, studies of risk management programs have been limited by their single-arm, single-center design and small sample sizes, and do not provide evidence about implementation and sustainability of the interventions.81 ‘Communication and resolution programs (CRPs) have been shown to reduce complaints and claims. CRPs aim to communicate adverse events more effectively to patients, investigate and explain the event, provide support and an apology, and offer compensation if appropriate. CRPs involve doctor/patient communication to reach a mutual agreement to resolve the dispute and include apology laws in which apologies made by medical practitioners cannot be used as evidence in medical malpractice litigation.81 There is limited evidence for the efficacy of peer review in reducing the risk of litigation. Peer review involves providing feedback to physicians deemed at higher risk of patient complaints or malpractice claims from trained colleagues. Doctors who report participation in CPD activities are less likely to receive quality of care-related complaints than those who do not report participating in CPD.81

    As we look forward to the next 50 years for the specialty of gynecologic oncology, investment in infrastructure and resources will be critical to ensuring that surgical decision making processes are sound and efficient. In order to bridge the gynecologic oncology infrastructure gap globally, there has to be improved access to fellowship training programs, international collaboration and tumor boards, advocacy and funding, and improvement in screening and prevention. As a specialty, we must work together to build cancer center capacity worldwide to ensure equitable care among all women. While cancer may represent a group of diseases for which the cost burden to a country is significant,82 it is the opinion of the authors of this article that the core of surgical decision making in gynecologic oncology in its purest form should be driven by patient outcomes, not by cost. Where equipoise or resistance exists within a center regarding changes in practice—for example, moving to an ERAS-driven service—cost-effectiveness analyses may influence change. While we are all driven by the individual patient in front of us with cervical cancer, the framework in which we make decisions about the treatment of this disease is heavily influenced by the capacity and need to ensure prevention strategies are available to all women. The influence of financial factors may precede or follow changes in surgical practices. A prime example of the latter is in the post-hoc assessments of the cost-effectiveness of laparoscopic surgery, which did not necessarily bear out the assumption that laparoscopic surgery was cheaper than traditional open surgery.83 Financial decisions in surgery will be influenced by the setting in which the surgery is being performed, particularly when one compares universal healthcare systems to user pays systems.84

    Conclusion

    There have been many important advances in the specialty of gynecologic oncology over the past 50 years, but there is much to be done so that surgical decision making, and ultimately patient outcomes, are enhanced by medicolegal, infrastructural, and financial factors and not limited by them.

    Ethics statements

    Patient consent for publication

    Ethics approval

    Not applicable.

    References

    Footnotes

    • PAC and RB are joint senior authors.

    • Contributors All authors contributed to the conception, writing, and editing of the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests PAC declares honoraria from Astra Zeneca unrelated to the submitted work.

    • Provenance and peer review Commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.