How to Define, Evaluate, and Identify Surgical Quality. Viewpoint of the ESGO Quality Assurance Committee

Transcription

1 How to Define, Evaluate, and Identify Surgical Quality Viewpoint of the ESGO Quality Assurance Committee Giovanni Aletti, MD European Institute of Oncology Milan, Italy

2 The best interest of the patient is the only interest to be considered, and in order that the sick may have the benefit of advancing knowledge, union of forces is necessary. Dr. William J. Mayo, 1910

3 Background The surgical management of advanced ovarian cancer involves complex surgery. Quality of surgical care is a major component of the multidisciplinary management of the disease. Implementation of a quality management program has been associated with longer survival in patients with advanced ovarian cancer.

4 Background The surgical management of advanced ovarian cancer involves complex surgery. Quality of surgical care is a major component of the multidisciplinary management of the disease. Implementation of a quality management program has been associated with longer survival in patients with advanced ovarian cancer.

5 Improving quality of care across Europe ESGO position To promote the training of gynecologic surgeons treating especially advanced stages of diseases ESGO fellowships To improve the average standard of surgical care for ovarian cancer surgery, and to build a network of certified centers. Centers meeting the targets will be granted an accreditation known by doctors, patients, patient advocacy groups, and governments. The mindset is not to be punitive, but to motivate. 5

6 TASK To develop a list of quality indicators for advanced ovarian cancer surgery that can be used in the clinical practice. Key characteristics: clear definition, clinical relevance, measurability (targets), feasibility, with a scientific basis.

7 4 steps - Modified Delphi Method I Nomination of an international panel of experts Identification of potential quality indicators N = 15 Identification of scientific evidence First evaluation Independent evaluation of the 15 potential quality indicators

8 and the Gyn-Onc troop Chairs Medical Oncology Pathology Radiation therapy Mol. Biology Radiology

9 We evaluated each indicator according to Relevance and Feasibility in clinical practice Second Evaluation Charles de Gaulle Airport First meeting, May 2015

10 The 10 retained quality indicators were sent by to 92 international reviewers to evaluate each indicator according to quality, relevance, and feasibility in clinical practice. Third evaluation 8 patients group representatives

11 Finalization of QI All open comments of reviewers were organized, sent to all workgroup members, then reviewed at the time of a second and third meeting of the workgroup >200 comments were received Definitions, specifications, and targets were systematically reviewed, taking into account external and internal comments. 13

12 Modified Delphi Method II External panel of international reviewers evaluates the relevance and feasibility of the 10 QI. Summer nd expert panel discussion. Integration of external panel comments. Sept 2015 Fourth evaluation 3 rd expert panel discussion. Final decision Jan 2016 Fifth evaluation

13 QI 1. Rate of complete surgical resection Complete abdominal surgical resection is defined by the absence of remaining macroscopic lesions after careful exploration of the abdomen. Overwhelming evidence supports complete cytoreduction in advanced stages as the best quality indicator of the surgical procedure. Complete cytoreduction appears to be the best surrogate marker for overall survival.

14 QI 1.1 Rate of complete surgical resection % Complete Resection N of pts with AOC with R0 All pts with AOC referred to the center > 65 % QI 1.2 Rate of primary debulking surgery (PDS) % of PDS Number of PDS Number all incoming patients with stage III/IV(a+b) > 50%

15 QI 2. Number of cytoreductive surgeries performed per center and per surgeon per year Number of surgeries performed per center per year: Optimal target: N 100 (score 5) Intermediate target: N 50 (score 3) Minimum target: N 20 (score1) 95% of surgeries are performed by surgeons operating on at least 10 patients a year.

16 QI 3.Surgery performed by a gynecologic oncologist Ovarian cancer patients will be operated on by a certified gynecologic oncologist or, in countries where certification is not organized, by a trained surgeon dedicated to the management of gynecologic cancer. Skills to successfully complete complex abdominal and pelvic surgery procedures necessary to achieve complete cytoreduction must be available. QI 4.Center participating in clinical trials in gyn onc Int J Gynecol Cancer 2005 Int J Gynecol Cancer 2009

17 QI. 5 Treatment planned at a multidisciplinary meeting Before any surgery, it is considered mandatory for every patient to be part of a decision-making process within a structured multidisciplinary team including: Gynaecologic oncologist Radiologist with a special interest in gynecologic oncology. Pathologist (if a biopsy is available) with a special interest in gynecologic cancer. Medical oncologist or gyn oncologist certified to deliver chemotherapy. QI. 6 Required preoperative workup Rule out unresectable parenchymal metastases by imaging. Rule out metastases from other primaries by any suitable method (markers and or biopsy under radiologic or laparoscopic guidance)

18 QI.7 Pre-, intra-, and post-operative management Adequate anesthesiologic and perioperative care Access to an intensive care unit Need for a comprehensive perioperative management program Adequate pain management Implementation of ERAS program QI. 8 Minimum required elements in op reports The operative report must be structured Size and location of disease at the beginning of the operation must be described All the areas of the abdominal and pelvic cavity must be evaluated and described The size and location of residual disease at the end of the operation Reasons for not achieving complete cytoreduction must be reported.

19 QI. 9 Minimum required elements in path reports The pathology report should contain all the required elements listed in the International Collaboration on Cancer Reporting (ICCR) Histopathology Guide QI. 10 Structured reporting of postop complications Reporting surgical morbidity and mortality during the first 30 days after surgery within structured meetings (M&M). Structured database of survival/recurrence events strongly encouraged.

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21 Accreditation Process The Guidelines and Assurance Quality Committee

22 Step 1 : Pre-Self-Assessment Requirements Existence of a database including: > 20 cases of cytoreductive surgeries for stage III-IV ovarian cancer/ year/institution All referred cases (N) Age Stage and sub-stage Performance status Number PDS Number IDS % of complete cytoreduction at primary and interval surgery

23 Step 1 : Pre-Self-Assessment Requirements Existence of a database including: > 20 cases of cytoreductive surgeries for stage III-IV ovarian cancer/ year/institution All referred cases (N) Age Stage and sub-stage Performance status Number PDS Number IDS % of complete cytoreduction at primary and interval surgery

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25 Downloadable Form on ESGO Website Self assesment Negative Score 28/40 Wait Positive Score >28/40 Apply!

26 Step 3 : ESGO Decision Assessment by ESGO ovarian cancer quality committee QI presentation in front of a designated committee of experts Rejected Do not resubmit before 2 years 5-year certification Accepted 2-year temporary certification

27 Accredited Center for Ovarian Cancer Surgery

28 Anything Else?

29 Centers of Excellence Criteria Certified center 50 cases per year PI of at least one clinical trial Biobank Basic/translational lab Accredited ESGO fellowship Role Running database shared with the other excellence centers Hosting visitors Organizing teaching sessions with live surgery demonstrations Providing material for ESGO e-academy

30 A letter of a ovarian cancer patient (external reviewer) As a patient I base my opinion on my own personal experience. I was diagnosed with ovarian cancer in stage IIIC in At that particular time about 32 hospitals in my country were allowed to operate on ovarian cancer patients. We only have 600 incidents of the disease per year This has since been changed, and we are now down to 4 hospitals with permission to operate on this disease. This means that the surgeons now have proper routine in operating ovarian cancer patients. I therefore personally know how important it is that the surgeon is trained in this difficult operation, and also that he has the opportunity to practice his skills regularly. I find the initiative from ESGO to establish some kind of rating and certification very beneficial to the ovarian cancer patient.

31 The best interest of the patient is the only interest to be considered, and in order that the sick may have the benefit of advancing knowledge, union of forces is necessary. Dr William J. Mayo, 1910

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