The optimal surgical management of patients with ovarian cancer includes a thorough staging with peritoneal and retroperitoneal assessment for early disease stages and a complete debulking with the removal of all macroscopic tumor for advanced disease stages. Disparities across different institutions in terms of optimal surgical management have been described. Surgical quality control programs constitute a real possibility to ensure and improve the quality of the surgery performed. Guidelines for surgery in early and advanced disease stages have been recently reviewed by the National Comprehensive Cancer Network (NCCN), and several quality indicators (QIs) have been proposed. These QIs can be used as a powerful tool to monitor, compare, and improve the quality of surgery across different centers and institutions. Furthermore, a transparent report of surgical outcomes through the creation of National and International Networks, adherence to the NCCN guidelines, and the establishment of quality control programs with a strong training and education component are key factors in enhancing the quality of surgery for patients with ovarian cancer.
Highlights
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Quality of surgery is of paramount importance for patients with ovarian cancer.
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Clinical practice guidelines and Quality Indicators for surgery in ovarian cancer may provide a basis for accreditation.
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Centralization of care is demonstrated to be superior in terms of surgical and oncological outcomes in ovarian cancer.
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Development of quality control programs constitute an opportunity for improving surgical and oncological outcomes.
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Incorporation of surgical training programs are part of a quality improvement process in ovarian cancer surgery.
The importance of the Quality of Care problem
In 1999, and subsequently in 2001, the Institute of Medicine raised several concerns regarding the quality of care. In these announcements, a lack of standardized systems to assess the quality was mainly pointed to attention as a key problem . Consequently, stakeholders have become more aware of variation in the quality and outcomes between hospitals and physicians. We can summarize three categories of stakeholders, namely, payers, patients, and practitioners. As physicians, we usually emphasize the former group, and in this way, we consider quality improvement initiatives as another “external force getting in our way of practicing” or “another obstacle or obligation” or “more paperwork.” However, we should not forget that the true stakeholders are the patients and ourselves as physicians—keeping this in our thoughts makes quality improvement a much more motivating issue to be considered.
There are many factors that may be involved in this variability in the deliverance of care: (1) lack of resources resulting in suboptimal structures and hospitals; (2) lack of certified referral centers for specific cancers; (3) lack of clinical guidelines that may be used across different institutions and physicians; (4) lack of training programs, resulting in a wide variability in individual physician’s performance.
Third-party payers (government or private) should be actively involved in developing strategies with an ultimate goal of transparent documentation of compliance with the surgical processes of care and surgical outcomes. In this way, the patient could choose a facility on the basis of the creation of specialized centers (referral centers) and payers to reimburse based upon compliance. Gynecologic Oncology societies and organizations are behind in national and international initiatives focused on surgical quality, relying primarily on external efforts.
An example of this effort was the National Initiative for Cancer Care Quality (NICCQ). The study was focused on patients with breast and colon cancer, analyzing five different metropolitan statistical areas (MSAs). They found that patients with breast cancer received 86% of recommended care and patients with colorectal cancer received 78% of recommended care. Adherence to quality measures was less than 85% for 18 of the 36 breast cancer measures, and significant variation across the different MSAs was observed for seven quality measures. For colorectal cancer measures, the adherence rate was less than 85% for 14 of the 25 patients, and one quality measure demonstrated statistically significant variation across the MSAs. They concluded that while reporting a substantial consistency with evidence-based practice, substantial variation in adherence to some quality measures points to significant opportunities for improvement .
Another great initiative in quality improvement in surgery comes from the American College of Surgeons. Briefly, from October 1991 to December 1993, the Veterans Health Administration (VHA) conducted the National VA Surgical Risk Study (NVASRS), validating a risk-adjustment model for the prediction of surgical morbidity and mortality. This model allowed different centers that participated in the study to monitor and compare their results to other centers. Following these results, the National VA Surgical Quality Improvement Program was started in January 1994. This has since evolved into the National Surgical Quality Improvement Program (NSQIP) to involve non-VA centers under the direction of the American College of Surgeons (ACS). Periodic comparative reports were produced, using a risk-adjusted model, generating observed/expected ratios of events (morbidity and mortality) for all hospitals. In this way, they provided a comparative data that aid hospital managers and care providers in identifying structures and processes of care that need to be improved at the local level. Interestingly, since the program started in the VA in 1991, the 30-day morbidity rate after major surgery has decreased by 45% and the 30-day mortality rate by 31%. The program underscored the importance of systems as principal determinants of outcome and quality of care and provided the tool of observed/expected ratio as reflective of the quality of these systems. In 2003, the VA Health System was positively cited by the Institute of Medicine for the initiatives employing performance measures .
Why is this problem of particular interest to the specialty of gynecologic oncologic surgery, especially for ovarian cancer?
Ovarian cancer is the leading cause of death among all gynecologic cancers . Unfortunately, the majority of patients present with advanced stage at the time of diagnosis . The stage distribution of ovarian cancer is as follows: roughly 70% of ovarian cancers are diagnosed at advanced stages (FIGO stage III–IV) and 30% at early stages (I–II) . The adequate surgical treatment for patients diagnosed with ovarian cancer is indicated by the stage of disease at the time of presentation. With the current treatment modalities, the 5-year survival rate is 30–40% for the patients with advanced stage versus 80–95% for those with cancer macroscopically confined to the ovaries/pelvis .
Guidelines for the surgical management of patients with ovarian cancer have been recently reviewed (NCCN guidelines) . According to these guidelines, surgical management of the patients with disease confined to the ovaries/pelvis (stage I/II) includes the removal of the tumor (possibly intact) and the genital tract, and an adequate staging of the peritoneum and the retroperitoneum. In those patients with advanced stage disease, optimal surgical management includes a debulking procedure with the aim of removing all the visible tumor, necessitating complex surgery, including radical procedures as extensive peritonectomies, bowel surgery, upper abdominal procedures, and retroperitoneal procedures. Hence, the quality of surgical care is a major component of the multidisciplinary management of this disease.
Unfortunately, rates of optimal debulking for patients with advanced ovarian cancer and rates of adequate staging procedures in early stages vary across hospitals and providers. Outcomes are more favorable when patients are operated by expert gynecologic oncologists . Despite this evidence, patients with gynecologic cancer are not always referred to tertiary centers. Adherence to the NCCN guidelines is indeed a crucial component of the quality of surgery performed .
The question that naturally arises after becoming aware of the consistency of the problem would be: “is it possible to do better? If yes, how?” In other words: “is it possible to assess and promote a high quality of surgery in ovarian cancer? How can we define the critical indicators that reflect indeed the surgical quality for ovarian cancer patients? How can we improve the quality of surgery that we deliver to our patients?”
In the most recent years, several efforts by different international societies have been made to look at quality measures in ovarian cancer surgery . There has been a considerable debate about which parameters should be used to reflect surgical quality. One way to assess the quality of surgical care is to evaluate the caseload of institutions, individual surgeons, and oncological outcomes: morbidity, mortality rates, quality of life, and patient satisfaction, overall and disease-free survival are some examples of these outcomes.
More recently, a subdivision of these parameters between “structural quality indicators” and “surgeon quality indicators” has been made to better identify the quality of care delivered and the potential areas of improvement .
“Structural quality indicators” describe the caseload in the specific center and the resources available in the center. These include, for example, the number and expertise of the staff employed, adequate timing from diagnosis/treatment, access to multidisciplinary teams, specific technologies, intensive care units, and nurse-to-patient ratios.
“Surgeon quality indicators” reflect the number of procedures performed by the surgeon per year, the rate of adequate surgical staging/complete surgical resection. These are most commonly used as a surrogate for surgical quality .
These indicators should describe the specific care that the patient actually received for each center. They have been used routinely as quality indicators for nonsurgical specialties (e.g. primary care physicians may be graded according to the proportion of appropriate patients in their practice who receive screening mammography) but are equally applicable to surgical specialties. Examples include guidelines for surgery, type of surgery performed, and the use of care pathways .
We performed this review with the specific aim of describing the different surgical quality indicators for early and advanced ovarian cancer. The quality of surgery performed is indeed correlated to patients’ outcomes, and the employment of such quality indicators must be seen as a possible step forward in the management and care of the patients with this aggressive disease.
Quality indicators for surgical staging in early stage ovarian cancer
According to the NCCN guidelines, all women with apparent early stage ovarian cancer should undergo a complete surgical FIGO staging . These procedures include: midline incision; careful evaluation of all peritoneal surfaces; washings of the peritoneal cavity; omentectomy; complete or selected lymphadenectomy of the pelvic and para-aortic lymph nodes; biopsy and/or resection of any suspicious lesions; random blind biopsies of normal peritoneal surfaces, including that from the undersurface of the right hemidiaphragm, bladder reflection, cul-de-sac, right and left paracolic recesses, and both pelvic sidewalls; total abdominal hysterectomy and BSO; appendectomy for mucinous histotypes. For selected patients, a minimally invasive approach may be considered by physicians/centers equipped to perform the abovementioned procedures.
An adequate surgical staging seems to be crucial in terms of oncological outcomes. In fact, a data analysis from the EORTC ACTION trial that involved selected patients who were supposed to have undergone thorough surgical staging for FIGO stage I or IIA showed that only 34% of the 448 patients enrolled into the trial were correctly staged. The authors noted that the most common omissions were the sampling of para-aortic lymph nodes (78%), biopsy of the diaphragm (55%), and sampling of pelvic lymph nodes (52%). One of the main reasons for these omissions reflected a lack of surgical expertise (e.g. low rate of surgeon quality indicators) and noted that they were more likely to occur in institutions treating less than five patients yearly. A low number of patients per center shows a defect in terms of “structural quality indicators.” An inadequate staging finally reflected in the overall oncological outcome: patients properly staged did not benefit from the adjuvant chemotherapy, whereas patients with inadequate surgical staging had a statistically significant improvement in cancer-specific and recurrence-free survival with the addition of adjuvant chemotherapy . A further study analyzed the same patients with a median follow-up of 10.1 years. This supported all the conclusions from the original study, additionally showing that the overall survival after optimal surgical staging was improved, even among the patients who had received adjuvant chemotherapy (HR = 1.89, 95% CI 0.99 to 3.60, p = 0.05). This supports the use of pelvic and para-aortic lymph node sampling in the management of those with early stage ovarian cancer .
The Gynecological Cancer Group of the EORTC, in a review article, developed a list of process quality indicators for an appropriate ovarian cancer staging that should be used by gynecological oncology surgeons and gynecological oncology units to audit and improve their practice in an easy and practical way ( Table 1 ) .
| Quality Indicators (QIs) Early stage ovarian cancer | Target |
|---|---|
| % Rate of patients with a suspicious ovarian mass undergoing staging laparotomy within 1 month after decision to treat or documented clinical or patient-related reason for delay; | ≥95% |
| % Rate of performed staging laparotomies for an ovarian mass suspected to be malignant performed through a vertical incision; | ≥95% |
| % Rate of performed staging laparotomies in which all of the following procedures are included: total hysterectomy, bilateral salpingo-oophorectomy, cytology of the peritoneal cavity, infracolic omentectomy, random peritoneal biopsies, and systematic pelvic and para-aortic lymphadenectomy if medium- or high-risk features; | ≥95% |
| % Rate of surgery surgical reports with documented presence or absence of cyst rupture before or during surgery | ≥95% |
| % Rate of surgery surgical reports with documented presence or absence of dense adhesions, and % rate of dense adhesions biopsied. | ≥95% |
| Quality Indicators (QIs) Advanced stage ovarian cancer | Target |
|---|---|
| Rates of Complete Surgical Resection | |
| Optimal | >65% |
| Minimal | <50% |
| No. of Cytoreductive Surgeries Performed Per Center and Per Surgeon Per Year | |
| Optimal | ≥100 |
| Intermediate | ≥50 |
| Minimal | ≥20 |
| Surgery Performed by a Gynecologic Oncologist or a Trained Surgeon Specifically Dedicated to Gynecological Cancers Management | ≥90% |
| Center Participating in Clinical Trials in Gynecologic Oncology. | Yes |
| Treatment Planned and Reviewed at a Multidisciplinary Team (MDT) Meeting | ≥95% |
| Required Preoperative Workup | ≥95% |
| Preoperative, Intraoperative, and Postoperative Management; | Yes |
| Minimum Required Elements in Operative Reports | ≥90% |
| Minimum Required Elements in Pathology Reports | ≥90% |
| Existence of a Structured Prospective Reporting of Postoperative Complications | Yes |
Five indicators for a staging laparotomy when the cancer is grossly confined to the pelvis were described as follows :
- 1.
Rate of patients with a suspicious ovarian mass undergoing staging laparotomy within 1 month after decision to treat or documented clinical or patient-related reason for delay.
- 2.
Rate of performed staging laparotomies for an ovarian mass suspected to be malignant performed through a vertical incision;
- 3.
Rate of performed staging laparotomies in which all of the following procedures are included: total hysterectomy, bilateral salpingo-oophorectomy, cytology of the peritoneal cavity, infracolic omentectomy, random peritoneal biopsies, and systematic pelvic and para-aortic lymphadenectomy if medium- or high-risk features;
- 4.
Rate of surgical reports with documented presence or absence of cyst rupture before or during surgery;
- 5.
Rate of surgical reports with documented presence or absence of dense adhesions, and rate of dense adhesions biopsied.
The first indicator evaluates the percentage of patients treated within 1 month after the initial clinical evaluation; reducing the timing of surgery reflects better in prognosis . Minimally invasive approach should be considered in selected cases; in fact, many authors have widely demonstrated the advantages of a minimally invasive technique and is also reported in the NCCN guidelines. The use of minimally invasive surgery has been gradually replacing open surgery. Several trials demonstrated that the laparoscopic gynecologic surgery offers to the patients a less postoperative pain, shorter hospital stay, rapid recovery, and better cosmetic outcome . Moreover, minimally invasive surgery may give additional advantages for patients with early stage ovarian cancer, permitting a faster recovery and a shorter interval to the start of adjuvant therapy, maintaining similar results in terms of oncological outcomes .
An adequate surgical staging is mainly addressed by the third indicator, allowing to obtain the main important prognostic factors for the evaluation of the overall and recurrence-free survival . A thorough staging including systematic pelvic and para-aortic lymphadenectomy should be performed by a gynecologic oncologist to rule out occult higher-stage disease. Data show that approximately 30% of patients undergoing complete staging surgery are upstaged .
The last two indicators evaluate further important risk factors in early stage ovarian cancer, the rupture of the tumor capsule before or during surgery and the presence of dense adhesions. The new FIGO classification stratifies the IC stage group in IC1 (surgical spillage) and IC2 (capsule ruptured before surgery or tumor on ovarian or Fallopian tube surface). This stratification has been done to reflect the different prognosis of these patients . All efforts should be made to avoid cyst rupture during the surgical procedure in order to prevent modifying the stage (upstaging); in case this happens, it should be reported in the surgical report to correctly stage the patients. The presence of dense adhesions has been considered to be the second most important prognostic factor in early disease, after the degree of differentiation of the tumor, by many authors . Therefore, all dense adhesions in patients with apparent early stage ovarian cancer should be biopsied and described in the surgical report as well.
Quality indicators for surgical staging in early stage ovarian cancer
According to the NCCN guidelines, all women with apparent early stage ovarian cancer should undergo a complete surgical FIGO staging . These procedures include: midline incision; careful evaluation of all peritoneal surfaces; washings of the peritoneal cavity; omentectomy; complete or selected lymphadenectomy of the pelvic and para-aortic lymph nodes; biopsy and/or resection of any suspicious lesions; random blind biopsies of normal peritoneal surfaces, including that from the undersurface of the right hemidiaphragm, bladder reflection, cul-de-sac, right and left paracolic recesses, and both pelvic sidewalls; total abdominal hysterectomy and BSO; appendectomy for mucinous histotypes. For selected patients, a minimally invasive approach may be considered by physicians/centers equipped to perform the abovementioned procedures.
An adequate surgical staging seems to be crucial in terms of oncological outcomes. In fact, a data analysis from the EORTC ACTION trial that involved selected patients who were supposed to have undergone thorough surgical staging for FIGO stage I or IIA showed that only 34% of the 448 patients enrolled into the trial were correctly staged. The authors noted that the most common omissions were the sampling of para-aortic lymph nodes (78%), biopsy of the diaphragm (55%), and sampling of pelvic lymph nodes (52%). One of the main reasons for these omissions reflected a lack of surgical expertise (e.g. low rate of surgeon quality indicators) and noted that they were more likely to occur in institutions treating less than five patients yearly. A low number of patients per center shows a defect in terms of “structural quality indicators.” An inadequate staging finally reflected in the overall oncological outcome: patients properly staged did not benefit from the adjuvant chemotherapy, whereas patients with inadequate surgical staging had a statistically significant improvement in cancer-specific and recurrence-free survival with the addition of adjuvant chemotherapy . A further study analyzed the same patients with a median follow-up of 10.1 years. This supported all the conclusions from the original study, additionally showing that the overall survival after optimal surgical staging was improved, even among the patients who had received adjuvant chemotherapy (HR = 1.89, 95% CI 0.99 to 3.60, p = 0.05). This supports the use of pelvic and para-aortic lymph node sampling in the management of those with early stage ovarian cancer .
The Gynecological Cancer Group of the EORTC, in a review article, developed a list of process quality indicators for an appropriate ovarian cancer staging that should be used by gynecological oncology surgeons and gynecological oncology units to audit and improve their practice in an easy and practical way ( Table 1 ) .
| Quality Indicators (QIs) Early stage ovarian cancer | Target |
|---|---|
| % Rate of patients with a suspicious ovarian mass undergoing staging laparotomy within 1 month after decision to treat or documented clinical or patient-related reason for delay; | ≥95% |
| % Rate of performed staging laparotomies for an ovarian mass suspected to be malignant performed through a vertical incision; | ≥95% |
| % Rate of performed staging laparotomies in which all of the following procedures are included: total hysterectomy, bilateral salpingo-oophorectomy, cytology of the peritoneal cavity, infracolic omentectomy, random peritoneal biopsies, and systematic pelvic and para-aortic lymphadenectomy if medium- or high-risk features; | ≥95% |
| % Rate of surgery surgical reports with documented presence or absence of cyst rupture before or during surgery | ≥95% |
| % Rate of surgery surgical reports with documented presence or absence of dense adhesions, and % rate of dense adhesions biopsied. | ≥95% |
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