%80%8fovarian... · 2019-09-13 · advanced ovarian cancer surgery- quality indicators -...

Advanced Ovarian Cancer Surgery

Quality Indicators

Description of quality indicatorsRating 1

ADVANCED OVARIAN CANCER SURGERY - QUALITY INDICATORS - Description of quality indicators -

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TABLE OF CONTENTS1. QUALITY INDICATORS - DEFINITIONS . .................................................................................. 3

1.1. Structural indicators . .............................................................................................. 3

1.2. Process indicators . ................................................................................................. 3

1.3. Outcome indicators . ............................................................................................... 3

2. PUBLISHED CLINICAL PRACTICE GUIDELINES & QUALITY INDICATORS CONSULTED . ............................... 4

3. LIST OF QUALITY INDICATORS . .......................................................................................... 5

4. DESCRIPTION OF QUALITY INDICATORS . ............................................................................... 6

4.1. Structural indicators ................................................................................................... 6

4.1.1. Quality indicator 1 . ....................................................................................................................................................................... 6

4.1.2. Quality indicator 2 . .................................................................................................................................................................. 7

4.1.3. Quality indicator 3 . .................................................................................................................................................................. 8

4.1.4. Quality indicator 4 . ................................................................................................................................................................ 12


4.2. Process indicators . ............................................................................................... 14





4.2.5. Quality indicator 10 . .............................................................................................................................................................. 20





4.3. Outcome indicators . ............................................................................................. 28


4.3.2. Quality indicator 16 . ........................................................................................................................................................ 35

5. APPENDIX A: COMPLEMENTARY BIBLIOGRAPHIC SEARCH . ......................................................... 36

6. APPENDIX B: OTHER REFERENCES CONSULTED . ..................................................................... 36


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1. QUALITY INDICATORS - DEFINITIONS1

1.1. Structural indicators“Structure” refers to health system characteristics that affect the system’s ability to meet the healthcare needs of individual patients or a community. Structural indicators describe the type and amountof resources used by a health system or organization to deliver programs and services, and theyrelate to the presence or number of staff, clients, money, beds, supplies, and buildings. Theassessment of structure is a judgment on whether care is being provided under conditions that areeither conductive or inimical to the provision of good care.

1.2. Process indicatorsProcess indicators assess what the provider did for the patient and how well it was done. Processesare a series of inter-related activities undertaken to achieve objectives. Process indicators measurethe activities and tasks in patient episodes of care. Some authors include the patient’s activities inseeking care and carrying it out in their definition of the health care process. Others limit this term tocare that health care providers are giving. It may be argued that providers are not accountable forthe patient’s activities and these, therefore, do not constitute part of the quality of care, but ratherfall into the realm of patient characteristics and behavior that influence patients’ health outcomes.

1.3. Outcome indicatorsOutcomes are states of health or events that follow care, and that may be affected by health care. Anideal outcome indicator would capture the effect of care processes on the health and wellbeing ofpatients and populations. Outcomes can be expressed as ‘The five Ds’: i death: a bad outcome ifuntimely; ii disease: symptoms, physical signs, an d laboratory abnormalities; iii discomfort:symptoms such as pain, nausea, or dyspnea; iv disability: impaired ability connected to usualactivities at home, work, or in recreation; and v dissatisfaction: emotional reactions to disease andits care, such as sadness and anger. Intermediate outcome indicators reflect changes in biologicalstatus that affect subsequent health outcomes. Some outcomes can only be assessed after years e.g.5-year cancer survival. It is therefore important to assess interm ediate outcome indicators. Theyshould be evidence-based and reflect the final outcome.

1 Definitions provided by Mainz, J. 2003). Defining and classifying clinical indicators for quality improvement. Int J QualHealth Care 156): 523 -30.


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2. PUBLISHED CLINICAL PRACTICE GUIDELINES & QUALITYINDICATORS CONSULTED

AHS 2013. "Epithelial ovarian, fallopian tube, and primary peritoneal cancer. "http://www.albertahealthservices.ca/hp/if-hp-cancer-guide-gyne005-epithelialovarian.pdf.

Gagliardi, A. R., Fung Kee Fung, M et al. 2005). "Development of ovarian cancer surgery quality indicators usinga modified Delphi approach." Gynecol Oncol 972): 446 -456.

Gonzalez Martin, A., A. Redondo, et al. 2013. "GEICO Spanish Group for Investigation on Ovarian Cancertreatment guidelines in ovarian cancer 2012." Clin Transl Oncol 157): 509 -525.

INCa 2009). "Cancer de l'ovaire - Traitement chirurgical." http://www.e-cancer.fr/publications/55-recommandations-de-pratique-clinique/593-traitement-chirurgical-du-cancer-de-lovaire-rapport-integral.

Ledermann, J. A., F. A. Raja, et al. 2013). "Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMOClinical Practice Guidelines for diagnosis, treatment and follow-up." Ann Oncol 24 Suppl 6: vi24-32.

NCCN 201 5. "Ovarian cancer including fallopian tube cancer and primary peritoneal cancer."http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf.

NHS 2011). "Ovarian cancer. The recognition and initial management of ovarian cancer."http://www.nice.org.uk/guidance/cg122/resources/guidance-ovarian-cancer-pdf.

NHS 2013). "Ovarian cancer, clinical quality performance indicators."http://www.healthcareimprovementscotland.org/our_work/cancer_care_improvement/cancer_qpis.aspx.

NICE 2014). "Ovarian cancer." http://pathways.nice.org.uk/pathways/ovarian-cancer#path=view%3A/pathways/ovarian-cancer/ovarian-cancer-overview.xml&content=view-index.

Poveda Velasco, A., A. Casado Herraez, et al. 2007). "Treatment guidelines in ovarian cancer." Clin Transl Oncol95): 308 -316.

Querleu, D., I. Ray-Coquard, et al. 2013). "Quality indicators in ovarian cancer surgery: report from the FrenchSociety of Gynecologic Oncology Societe Francaise d'Oncologie Gynecologique, SFOG." Ann Oncol 2411):2732-2739.

SIGN 2013). "Management of epithelial ovarian cancer." http://www.sign.ac.uk/pdf/sign135.pdf.

Verleye, L., P. B. Ottevanger, et al. 2009. "EORTC -GCG process quality indicators for ovarian cancer surgery."Eur J Cancer 454): 517 -526.

Wagner, U. et al. 2013). S3 -Guideline on Diagnostics, Therapy and Follow-up of Malignant Ovarian Tumours:Short version 1.0 - AWMF registration number:032/035OL, June 2013. Geburtshilfe Frauenheilkd 739): 874 -889.


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3. LIST OF QUALITY INDICATORS

STRUCTURAL INDICATORS

1. VOLUME OF OVARIAN SURGERYquality indicator published by Gagliardi et al. 2005

2. INCLUSION IN THE SURGICAL TEAM OF A MEDICAL ONCOLOGISTqual ity indicator published by Querleu et al. 2013

3. SURGERY PERFORMED BY A GYNECOLOGIC ONCOLOGISTquality indicator published by Gagliardi et al. 2005 , Querleu et al. 2013 and Wagner et al. 2013

4. INCLUSION OF PATIENTS IN CLINICAL TRIALSqua lity indicator published by Gagliardi et al. 2005 and Querleu et al. 2013

5. DELAY BETWEEN THE DECISION TO TREAT AND TREATMENTquality indicator published by Gagliardi et al. 2005 and Verleye et al. 2009

PROCESS INDICATORS

6. PREOPERATIVE INVESTIGATIONS CA 125 + CT SCANquality indicator published by Querle u et al. 2013

7. PRETREATMENT MULTIDISCIPLINARY DECISION-MAKING PROCESSquality indicator published by Gagliardi et al. 2005, Querleu et al. 2013 and NHS 2013

8. ANAESTHETIC MANAGEMENTquality indicator published by Querleu et al. 2013

9. MIDLINE LAPAROTOMYquality indicator published by Querleu et al. 2013

10. PELVIC AND PARA-AORTIC LYMPHADENECTOMYq uality indicator published by Verleye et al. 2009 and Querleu et al. 2013

11. DEBULKING OPERATIONquality indicator published by Verleye et al. 2009

12. PATHOLOGY REPORTquality indicator published by Gagliardi et al. 2005 , Querleu et al. 2013 and NHS 2013

13. OPERATIVE REPORTquality i ndicator published by Gagliardi et al. 200 5, Verleye et al. 2009 and Querleu et al. 2013

14. INTRAOPERATIVE FROZEN SECTIONSquality indicator published by Querleu et al. 2013

OUTCOME INDICATORS

15. COMPLETE SURGICAL RESECTIONquality in dicator published by Gagliardi et al. 2005 , Verleye et al. 2009, Querleu et al. 2013, NHS 2013 and Wagner et al. 2013

16. PROSPECTIVE REPORTING OF COMPLICATIONSquality indicator publis hed by Gagliardi et al. 2005 and Querleu et al. 2013


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4. DESCRIPTION OF QUALITY INDICATORS

4.1. Structural indicators

4.1.1. Quality indicator 1

VOLUME OF OVARIAN SURGERY

QUALITY INDICATOR TITLE.

Title provided by Gagliardi et al. 2005): Volume of ovarian cancer surgery by institution per year. Volume of ovariancancer surgery by surgeon per year.

DESCRIPTION.

Description provided by Gagliardi et al. 2005): Not specified.

SPECIFICATIONS numerator 1, denominator2, exclusions .

Specifications provided by Gagliardi et al. 2005): Not specified.

TARGET.

Target provided by Gagliardi et al. 2005): Not specified.

SOURCE DOCUMENTATION.

References provided by Gagliardi et al. 2005): This indicator was proposed by the panel and not extracted from themedical literature.

Additional references identified 3:

o Brookfield, K. F., M. C. Cheung, et al. 2009). "Will patients benefit from regionalization of gynecologic cancer care?" PLoS One 41):e4049.

o Du Bois, A., J. Rochon, et al. 2005). "Pattern of care and impact of participation in clinical studies on the outcome in ovariancancer." Int J Gynecol Cancer 152): 183 -191.

o Elit, L. M., S. J. Bondy, et al. 2008). "Surgical outcomes in women with ovarian cancer." Can J Surg 515): 346 -354.

o Ledermann, J. A., F. A. Raja, et al. 2013). "Newly diagnosed and relaps ed epithelial ovarian carcinoma: ESMO Clinical PracticeGuidelines for diagnosis, treatment and follow-up." Ann Oncol 24 Suppl 6: vi24-32.

o Mercado, C., D. Zingmond, et al. 2010). "Quality of care in advanced ovarian cancer: the importance of provider spec ialty." GynecolOncol 1171): 18 -22.

o Paulsen, T., K. Kjaerheim, et al. 2006). "Improved short -term survival for advanced ovarian, tubal, and peritoneal cancer patientsoperated at teaching hospitals." Int J Gynecol Cancer 16 Suppl 1: 11-17.

o Schrag, D., C. Earle, et al. 2006). "Associations between hospital and surgeon procedure volumes and patient outcomes afterovarian cancer resection." J Natl Cancer Inst 983): 163 -171.

o Vernooij, F., A. P. Heintz, et al. 2009. "Specialized and high -volume care leads to better outcomes of ovarian cancer treatment inthe Netherlands." Gynecol Oncol 1123): 455 -461.

o Vernooij, F., A. P. Heintz, et al. 2008). "Specialized care and survival of ovarian cancer patients in The Netherlands: nationwidecohort study." J Natl Cancer Inst 1006): 399 -406.

o Vernooij, F., P. Heintz, et al. 2007. "The outcomes of ovarian cancer treatment are better when provided by gynecologiconcologists and in specialized hospitals: a systematic review." Gynecol Oncol 1053): 801 -812.

1: number of women in whom a specific test or intervention has been performed; 2: number of women in whom this test or interventionshould have been performed; 3: the complementary bibliographic search is described in the appendix A.


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INCLUSION IN THE SURGICAL TEAM OF A MEDICAL ONCOLOGIST


Title provided by Querleu et al. 2013): Formalized collaboration of the surgical team with a medical oncologist.

DESCRIPTION.

Description provided by Querleu et al. 2013): Institutions managing ovarian cancers include the services of a medicaloncologist.


Specifications provided by Querleu et al. 2013): Not specified.

TARGET.

Target provided by Querleu et al. 2013): 100% of institutions not having a medical oncology service or without thepermanent on-site presence of a medical oncologist should establish a formal relationship with a medical oncologyteam.


References provided by Querleu et al. 2013):

o Stockton, D and Davies, T. 2000). Multiple cancer site comparison of adjusted survival by hospital of treatment: an East Ang lianstudy. Br J Cancer 821): 208 -12.

o Vernooij, F., P. Heintz, et al. 2007. "The outcomes of ovarian cancer treatment are better when provided by gynecologiconcologists and in specialized hospitals: a systematic review." Gynecol Oncol 1053): 801 -812.

Additional references identified 3: no additional reference identified.



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SURGERY PERFORMED BY A GYNECOLOGIC ONCOLOGIST


Title provided by Gagliardi et al. 2005): Proportion of patients undergoing primary ovarian cancer surgery by agynecologic oncologist.

Title provided by Querleu et al. 2013): A team consisting of at least two surgeons who are trained in abdominal andpelvic surgery is necessary to achieve complete cytoreduction; a minimum of ten cytoreductive surgeries per surgeonper year is required.

Title provided by Wagner et al. 2013): Surgery for advanced ovarian cancer.

DESCRIPTION.


Description provided by Querleu et al. 2013): This represents the number of stage IIIc or IV ovarian cancers thatreveive surgical management before upfront surgery or after neoadjuvant chemotherapy interval surgery).Exploratory endoscopies, exploratory laparotomies, or surgeries limited to tissue biopsy, or surgeries that do notinclude at least a bilateral salpingo-oophorectomy, hysterectomy if applicable, and a comprehensive peritonealstaging including omentectomy are not included.

Description provided by Wagner et al. 2013): The diagnosis of patients unexpectedly diagnosed with advancedovarian cancer must be confirmed histologically and the extent of spread described. The definitive treatment mustthen be carried out by a gynaecological oncologist in a suitable facility.




Specifications provided by Wagner et al. 2013):

o Numerator: Number of patients whose definitive surgery was done by a gynarcological oncologist.o Denominator: All patients with a primary diagnosis of ovarian cancer FIGO ≥ IIB after surgical therapy has been completed.

o Exclusions: not specified.

TARGET.


Target provided by Querleu et al. 2013: A number of 10 procedures per surgeon per year and 20 interventions perinstitution per year are proposed as an objective. To ensure continuity of care, at least two surgeons are required.

Target provided by Wagner et al. 2013): Surgery to be performed as often as possible by a gynaecological oncologist.


References provided by Gagliardi et al. 2005):

o 1994). National Institutes of Health Consensus Development Conference Statement. Ovarian cancer: screening, treatment, andfollow-up. Gynecol Oncol 553 Pt 2): S4 -14.

o 1995). NIH consen sus conference. Ovarian cancer. Screening, treatment, and follow-up. NIH Consensus development Panel onOvarian Cancer. JAMA 2736): 491 -7.

o 1998a. ACOG educational bulletin. Ovarian cancer. Number 205, August 1998 replaces No. 141, May 1990). American C ollege ofObstetricians and Gynecologists. Int J Gynaecol Obstet 633): 301 -10.

1: number of women in whom a specific test or intervention has been performed; 2: number of women in whom this test or interventionshould have been performed.


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Quality indicator 3 continued


SOURCE DOCUMENTATION. continued

References provided by Gagliardi et al. 2005) continued :

o 1998b. Practice guidelines: ovarian cancer. Society of Gynecologic Oncologis ts Medical Practice and Ethics Committee. OncologyWilliston Park 121): 129 -33.

o Bosze, P. et al. 2000). Consensus statements on prognostic factors in epithelial ovarian carcinoma; report of the ConsensusMeeting organized by the European Society of Gynaecological Oncology, ESGO. Eur J Gynaecol Oncol 215): 513 -26.

o Bristow, R.E. 2000). Surgical standards in the management of ovarian cancer. Curr Opin Oncol 125): 474 -80.

o Camci, C. and Bata, O. 2002). Neoadjuvant chemotherapy in ovarian cancer. Eur J Gynaecol Oncol 235): 437 -41.o Curtin, J.P. and Shapiro, F. 1997). Adjuvant therapy in gynecologic malignancies. Ovarian, cervical, and endometrial cancer. Surg

Oncol Clin N Am 64): 813 -30.

o Favalli, G; Odicino, F. and Pecorelli, S. 2000). Surgery of advanc ed malignant epithelial tumours of the ovary. Forum Genova 104):312-20.

o O’Hanlan, K.A. 1993). Principles of surgical management of ovarian carcinomas. Pathology Phila 12): 477 -89.


o Aletti, G. D., B. S. Gostout, et al. 2006). "Ovarian cancer surgical resectability: relative impact of disease, patient status, andsurgeon." Gynecol Oncol 1001): 33 -37.

o Bristow, R. E., M. L. Zahurak, et al. 2009). "Impact of surgeon and hospital ovarian cancer surgical cas e volume on in-hospitalmortality and related short-term outcomes." Gynecol Oncol 1153): 334 -338.

o Bristow, R. E., B. E. Palis, et al. 2010). "The National Cancer Database report on advanced -stage epithelial ovarian cancer: impact ofhospital surgical case volume on overall survival and surgical treatment paradigm." Gynecol Oncol 1183): 262 -267.

o Cibula, D. et al. 2011). Training in bowel and upper abdominal surgery in gynaecological oncology: European Society ofGynecological Oncology ESGO Statement. Int J Gynecol Cancer 217): 1264 -5.

o du Bois, A., J. Rochon, et al. 2009). "Variations in institutional infrastructure, physician specialization and experience, and outcomein ovarian cancer: a systematic review." Gynecol Oncol 1122): 422 -436.

o Goff, B. A., B. J. Matthews, et al. 2007). "Predictors of comprehensive surgical treatment in patients with ovarian cancer." Cancer10910): 2031 -2042.

o Hoskins, W., Rice, L. and Rubin, S. 1997). Ovarian cancer surgical practice guidelines. Society of Surgical Oncolo gy practiceguidelines. Oncology Williston Park , 116): 896 -900, 903-4.

o Ioka, A., H. Tsukuma, et al. 2007). "Hospital procedure volume and survival of cancer patients in Osaka, Japan: a population -basedstudy with latest cases." Jpn J Clin Oncol 377): 544-553.

o Kumpulainen, S. Grenman, S. Kyyronen, P., Pukkala, E. and Sankila, R. 2002). Evidence of benefit from centralized treatment ofovarian cancer: a nationwide population-based survival analysis in Finland. Int J Cancer 1025): 541 -4.

o Kumpulainen, S., R. Sankila, et al. 2009). "The effect of hospital operative volume, residual tumor and first -line chemotherapy onsurvival of ovarian cancer - a prospective nation-wide study in Finland." Gynecol Oncol 1152): 199 -203.

o Luyckx, M. et al. 2012). Maximal cytoreduction in patients with FIGO stage IIIC to stage IV ovarian, fallopian, and peritoneal cancerin day-to-day practice: a Retrospective French Multicentric Study. Int J Gynecol Cancer 228): 1337 -43.

o Marth, C. et al. 2009). Influence of department vo lume on survival for ovarian cancer: results from a prospective quality assuranceprogram of the Austrian Association for Gynecologic Oncology. Int J Gynecol Cancer 191): 94 -102.

o Oberaigner, W. and Stuhlinger, W. 2006). Influence of department volume on cancer survival for gynaecological cancers--apopulqtion-based study in Tyrol, Austria. Gynecol Oncol 1032): 527 -34.

o Paulsen, T. Szczesny, W., Kaern, J., Vistad, I. and Tropé, C. 2012). Improved 8 -year survival for patients with stage IIIC ovariancancer operated on at teaching hospitals: population-based study in Norway 2002. Clin Ovarian Other Gynecol Cancer 52): 60 -6.


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SOURCE DOCUMENTATION continued

References provided by Wagner et al. 2013):

o ACNNBCC 2004). Clinical practice guidelines for the management of women with epithelial ovarian cancer. The Australian Cance rNetwork and National Breast Cancer Centre. Camperdown. NSW: National Breast Cancer Centre.

o Aletti, G. D., E. L. Eisenhauer, et al. 2011). "Identification of patient groups at highest risk from traditional approach to ovariancancer treatment." Gynecol Oncol 1201): 23 -28.

o Axtell, A. E., M. H. Lee, et al. 2007). "Multi -institutional reciprocal validation study of computed tomography predictors ofsuboptimal primary cytoreduction in patients with advanced ovarian cancer." J Clin Oncol 254): 384 -389.

o Bristow, R. E., E. L. Eisenhauer, et al. 2007). "Delaying the primary surgical effort for ad vanced ovarian cancer: a systematic reviewof neoadjuvant chemotherapy and interval cytoreduction." Gynecol Oncol 1042): 480 -490.

o Du bois, Reuss, A. et al. 2009). "Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: a com binedexploratory analysos of 3 prospectively randomized phase 3 multicenter trials: by the Arbeitsgemeinschaft GynaekologischeOnkologie Studiengruppe Ovarialkarzinom AGO -OVAR and the Groupe d’Investigateyrs Nationaux pour les Etudes des Cancers del’Ovaire GINECO.” Cancer 1156): 1234 -1244.

o du Bois, A., J. Rochon, et al. 2009). "Variations in institutional infrastructure, physician specialization and experience, and outcomein ovarian cancer: a systematic review." Gynecol Oncol 1122): 422 -436.

o Einenkel, J., R. Ott, et al. 2009). "Characteristics and management of diaphragm involvement in patients with primary advanced -stage ovarian, fallopian tube, or peritoneal cancer." Int J Gynecol Cancer 197): 1288 -1297.

o Elit, L. M., S. J. Bondy, et al. 2008). "Surgical outcomes in women with ovarian cancer." Can J Surg 515): 346 -354.o Gadducci, A., E. Sartori, et al. 2005). "Relationship between time interval from primary surgery to the start of taxane - plus

platinum-based chemotherapy and clinical outcome of patients with advanced epithelial ovarian cancer: results of a multicenterretrospective Italian study." J Clin Oncol 234): 751 -758.

o Gerestein, C. G., R. A. Damhuis, et al. 2009). "Causes of postoperative mortality after surgery for ovarian cancer." Eur J Cancer4516): 2799 -2803.

o Gerestein, C. G., M. J. Eijkemans, et al. 2009). "The prediction of progression -free and overall survival in women with an advancedstage of epithelial ovarian carcinoma." BJOG 1163): 372 -380.

o Gerestein, C. G., D. W. van der Spek, et al. 2009). "Prediction of residual disease after primary cytoreductive surgery for advanced -stage ovarian cancer: accuracy of clinical judgment." Int J Gynecol Cancer 199): 1511 -1515.

o Randall, T.C. and Rubin, S.C. 1999). Surgical management of ovarian cancer. Semin Surg Oncol 173): 173 -80.

o Tixier, H., J. Fraisse, et al. 2010). "Evaluation of pelvic posterior exenteration in the management of advanced -stage ovariancancer." Arch Gynecol Obstet 2813): 505 -510.

o Trope, C. and J. Kaern 2006). "Pr imary surgery for ovarian cancer." Eur J Surg Oncol 328): 844 -852.o Vernooij, F., P. Heintz, et al. 2007. "The outcomes of ovarian cancer treatment are better when provided by gynecologic

oncologists and in specialized hospitals: a systematic review." Gynecol Oncol 1053): 801 -812.

o Wimberger, P., N. Lehmann, et al. 2007). "Prognostic factors for complete debulking in advanced ovarian cancer and its impact onsurvival. An exploratory analysis of a prospectively randomized phase III study of the Arbeitsgemeinschaft GynaekologischeOnkologie Ovarian Cancer Study Group AGO -OVAR." Gynecol Oncol 1061: 69 -74.

o Wimberger, P. et al. 2010). Influence of residual tumor on outcome in ovarian cancer patients with FIGO stage IV disease: anexploratory analysis of the AGO-OVAR Arbeitsgemeinschaft Gynarkologische Onkologie Ovarian Cancer Study. Ann Surg Oncol176): 1642 -8.


o Chan, J. K., D. S. Kapp, et al. 2007). "Influence of the gynecologic oncologist on the survival of ovaria n cancer patients." ObstetGynecol 1096): 1342 -1350.

o Earle, C. C., D. Schrag, et al. 2006). "Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients." JNatl Cancer Inst 983): 172 -180.

o Elit, L., S. Bondy, et al. 2006). "The quality of the operative report for women with ovarian cancer in Ontario." J Obstet GynaecolCan 2810): 892 -897.

1: the complementary bibliographic search is described in the appendix A.


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Additional references identified 1 continued :

o Engelen, M. J., H. E. Kos, et al. 2006). "Surgery by consultant gynecologic oncologists improves survival in patients with ovariancarcinoma." Cancer 1063): 589 -598.

o Ghaemmaghami, F., M. Hassanzadeh, et al. 2010). "Centralization of ovarian cancer surgery: do patients benefit?" Eur J GynaecolOncol 314): 429 -433.

o Goff, B. A., B. J. Matthews, et al. 2007). "Predictors of comprehensive surgical treatment in patients with ovarian cancer." Cancer10910): 2031 -2042.

o Gonzalez Martin, A., A. Redondo, et al. 2013). "GEICO Spanish Group for Investigation on Ovarian Cancer treatment guidelines inovarian cancer 2012." Clin Transl Oncol 157 : 509 -525.

o INCa 2009). "Cancer de l'ovaire - Traitement chirurgical." http://www.e-cancer.fr/publications/55-recommandations-de-pratique-clinique/593-traitement-chirurgical-du-cancer-de-lovaire-rapport-integral.

o Kumpulainen, S., T. Kuoppala, et al. 2006). "Surgical treatment of ovarian cancer in different hospital categories --a prospectivenation-wide study in Finland." Eur J Cancer 423): 388 -395.

o Ledermann, J. A., F. A. Raja, et al. 2013). "Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practi ceGuidelines for diagnosis, treatment and follow-up." Ann Oncol 24 Suppl 6: vi24-32.

o Mercado, C., D. Zingmond, et al. 2010). "Quality of care in advanced ovarian cancer: the importance of provider specialty." GynecolOncol 1171): 18 -22.

o NCCN 2015). "Ovarian cancer including fallopian tube cancer and primary peritoneal cancer."http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf.

o Paulsen, T., K. Kjaerheim, et al. 2006). "Improved short -term survival for advanced ovarian, tubal, and peritoneal cancer patientsoperated at teaching hospitals." Int J Gynecol Cancer 16 Suppl 1: 11-17.

o Vernooij, F., A. P. Heintz, et al. 2009. "Specialized and high -volume care leads to better outcomes of ovarian cancer treatment inthe Netherlands." Gynecol Oncol 1123): 455 -461.

o Wagner, U. et al. 2013). S3 -Guideline on Diagnostics, Therapy and Follow-up of Malignant Ovarian Tumours: Short version 1.0 -AWMF registration number:032/035OL, June 2013. Geburtshilfe Frauenheilkd 739): 874 -889.



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INCLUSION OF PATIENTS IN CLINICAL TRIALS


Title provided by Gagliardi et al. 20 05: Proportion of patients with high risk or advanced ovarian cancer accrued toovarian clinical trials.

Title provided by Querleu et al. 2013): Institutional contributions to ovarian cancer clinical trials.

DESCRIPTION.

Description provided by Gagliardi et al. 2005) : Not specified.

Description provided by Querleu et al. 2013): The institution is involved in at least one clinical trial programme.


Specifications provided by Gagliardi et al. 2005) : Not specified.


TARGET.

Target provided by Gagliardi et al. 2005) : Not specified.

Target provided by Querleu et al. 2013): Multidisciplinary tumour board makes the proposal to participate in aregistered trial to at least 10% of patients. This is the target set by the French Cancer Plan 2009-2013.



o 1994). Natioanl Institutes of Health Consensus Development Conference Statement. Ovarian cancer: screening, treatment, andfollow-up. Gynecol Oncol 553 Pt2): S4 -14.

o 1995). NIH consensus conference. Ovarian cancer. Screening, treatment, and follow -up. NIH Consensus Development Panel onOvarian Cancer. JAMA 2736): 491 -7.

o Bosze, P. et al. 2000). Consensus statements on prognosti c factors in epithelial ovarian carcinoma. Report of the ConsensusMeeting organized by the European Society of Gynaecological Oncology, ESGO. Eur J Gynaecol Oncol 215): 513 -26.

o Curtin, J.P. and Shapiro, F. 1997). Adjuvant therapy in gynecologic malignan cies. Ovarian, cervical, and endometrial cancer. SurgOncol Clin N Am 64): 813 -30.

o Morgan, R.J., Jr et al. 1996). NCCN Ovarian Cancer Practice Guidelines. The National Comprehensive Cancer Network. OncologyWilliston Park 1011 Suppl: 293 -310.

o O’Hanlan, K.A. 1993). Principles of surgical management of ovarian carcinomas. Pathology Phila 12): 477 -89.

o Ozols, R.F. 2000). Management of advanced ovarian cancer consensus summary. Advanced Ovarian Cancer Consensus Faculty.Semin Oncol 273 Suppl 7): 47 -9.

o Trimble, E.L. 2000). Innovative therapies for advanced ovarian cancer. Semin Oncol 273 Suppl 7): 24 -30.


o Du Bois, A., J. Rochon, et al. 2005). "Pattern of care and impact of participation in clinical studi es on the outcome in ovariancancer." Int J Gynecol Cancer 152): 183 -191.

o Robinson, W. R., J. Ritter, et al. 2009). "Clinical trial participation is associated with improved outcome in women with ovariancancer." Int J Gynecol Cancer 191): 124 -128.




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DELAY BETWEEN THE DECISION TO TREAT AND TREATMENT


Title provided by Gagliardi et al. 2005): Proportion of patients who undergo definitive surgery or treatment withintwo weeks of decision to treat.

Title provided by Verleye et al. 2009): % of patients with advanced-stage ovarian cancer undergoing debulkinglaparotomy within 31 days after decision to treat or documented clinical or patient-related reason for delay.

DESCRIPTION.


Description provided by Verleye et al. 2009): Not specified.



Specifications provided by Verleye et al. 2009) : Not specified.

TARGET.

Target provided by Gagliardi et al. 2005) : Not specified.

Target provided by Verleye et al. 2009) : ≥ 95%


References provided by Gagliardi et al. 2005): this indicator was proposed by the panel and not extracted from themedical literature.

References provided by Verleye et al. 2009):

o Blythe, J.G. and Wahl, T.P. 1982). Debulking surgery: does it increase the quality of s urvival? Gynecol Oncol 143): 396 -408.




14

4.2. Process indicators


PREOPERATIVE INVESTIGATIONS CA 125 + CT SCAN


Title provided by Querleu et al. 2013): Preoperative investigations should include, at minimum, a computerizedtomography scan, and measurement of marker Ca 125.

DESCRIPTION.

Description provided by Querleu et al. 2013): A preoperative scan assessing the pelvic, abdominal, and chest regionsmust be carried out according to the recommendations of the European Society of Radiologists. Tumour markerassays must include at least the determination of Ca 125. Assessment may also include laparoscopy.


Specifications provided by Querleu et al. 2013) : Not specified.

TARGET.

Target provided by Querleu et al. 2013) : 100% of patients records will contain this information.


References provided by Querleu et al. 20 13):

o Colombo, N. et al. 2010). Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines fordiagnosis, treatment and follow-up. Ann Oncol 21Suppl 5): v23 -30.

o Forstner, R., E. Sala, et al. 2010). "ESUR guidelines: ova rian cancer staging and follow-up." Eur Radiol 2012): 2773 -2780.


o Arits, A. H., J. E. Stoot, et al. 2008). "Preoperative serum CA125 levels do not predict suboptimal cytoreductive surgery in epithelialovarian cancer." Int J Gynecol Cancer 184): 621 -628.

o Barlow, T. S., M. Przybylski, et al. 2006). "The utility of presurgical CA125 to predict optimal tumor cytoreduction of epithelialovarian cancer." Int J Gynecol Cancer 162): 496 -500.

o Chudecka-Glaz, A. M., A. A. Cymbaluk-Ploska, et al. 2014). "Serum HE4, CA125, YKL -40, bcl-2, cathepsin-L and prediction optimaldebulking surgery, response to chemotherapy in ovarian cancer." J Ovarian Res 7: 62.

o de Jong, D., M. J. Eijkemans, et al. 2007). "Preoperative predictors for residual tumor after surgery in patients with ovariancarcinoma." Oncology 725 -6): 293-301.

o Everett, E. N., C. C. Heuser, et al. 2005). "Predictors of suboptimal surgical cytoreduction in women treated with initialcytoreductive surgery for advanced stage epithelial ovarian cancer." Am J Obstet Gynecol 1932): 568 -574; discussion 574-566.

o Fotopoulou, C., R. Richter, et al. 2010). "Can complete tumor resection be predicted in advanced primary epithelial ovarian cancer?A systematic evaluation of 360 consecutive patients." Eur J Surg Oncol 3612): 1202 -1210.

o Frederick, P. J., P. T. Ramirez, et al. 2011). "Preoperative factors predicting survival after secondary cytoreduction for r ecurrentovarian cancer." Int J Gynecol Cancer 215): 831 -836.

o Fujwara, K., K. Yoshino, et al. 2011). "Usefulness of computed tomography in predicting cytoreductive surgical outcomes forovarian cancer." Arch Gynecol Obstet 2846): 1501 -1507.

o Furukawa, N., Y. Sasaki, et al. 2013). "CA -125 cut-off value as a predictor for complete interval debulking surgery after neoadjuvantchemotherapy in patients with advanced ovarian cancer." J Gynecol Oncol 242): 141 -145.

o Gemer, O., M. Gdalevich, et al. 2009. "A multicenter validation of computerized tomography models as predictors of non - optimalprimary cytoreduction of advanced epithelial ovarian cancer." Eur J Surg Oncol 3510): 1109 -1112.

o Gemer, O., M. Lurian, et al. 2005). "A multicenter study of CA 125 level as a predictor of non -optimal primary cytoreduction ofadvanced epithelial ovarian cancer." Eur J Surg Oncol 319): 1006 -1010.



15


PREOPERATIVE INVESTIGATIONS CA 125 + CT SCAN



o Gilani, M. M., M. Karimi Zarchi, et al. 20 07). "A study to evaluate the utility of presurgical CA125 to predict optimal tumorcytoreduction of epithelial ovarian cancer." Gynecol Oncol 1053): 780 -783.

o Glaser, G., M. Torres, et al. 2013). "The use of CT findings to predict extent of tumor at prim ary surgery for ovarian cancer."Gynecol Oncol 1302): 280 -283.

o Ibeanu, O. A. and R. E. Bristow 2010). "Predicting the outcome of cytoreductive surgery for advanced ovarian cancer: a revie w." IntJ Gynecol Cancer 20 Suppl 1: S1-11.

o Jung, D. C., S. Kang, et al. 2013). "Use of complex surgical procedures, patterns of tumor spread, and CA -125 predicts a risk ofincomplete cytoreduction: a Korean Gynecologic Oncology Group study KGOG -3022)." Gynecol Oncol 1312): 336 -340.

o Kang, S., T. J. Kim, et al. 2010). "Preoperative serum CA-125 levels and risk of suboptimal cytoreduction in ovarian cancer: a meta-analysis." J Surg Oncol 1011): 13 -17.

o Kim, H. S., N. H. Park, et al. 2008). "Significance of preoperative serum CA -125 levels in the prediction of lymph node metastasis inepithelial ovarian cancer." Acta Obstet Gynecol Scand 8711): 1136 -1142.

o Mironov, O., N. M. Ishill, et al. 2011). "Pleural effusion detected at CT prior to primary cytoreduction for stage III or IV ovariancarcinoma: effect on survival." Radiology 2583): 776 -784.

o Mury, D., L. Woelber, et al. 2011). "Prognostic and predictive relevance of CA -125 at primary surgery of ovarian cancer." J CancerRes Clin Oncol 1377): 1131 -1137.

o Osman, N., N. O'Leary, et al. 2008). "Correlation of serum CA125 with stage, grade and survival of patients with epithelial ovariancancer at a single centre." Ir Med J 1018): 245 -247.

o Pelissier, A., C. Bonneau, et al. 2014). "CA125 kinetic parameters predict optimal cytoreduction in patients with advanced epithelialovarian cancer treated with neoadjuvant chemotherapy." Gynecol Oncol 1353): 542 -546.

o Qayyum, A., F. V. Coakley, et al. 2005). "Role of CT and MR imaging in predicting optimal cytoreduction of newly diagnosed primaryepithelial ovarian cancer." Gynecol Oncol 962): 301 -306.

o Rodriguez, N., J. A. Rauh-Hain, et al. 2012). "Changes in serum CA -125 can predict optimal cytoreduction to no gross residualdisease in patients with advanced stage ovarian cancer treated with neoadjuvant chemotherapy." Gynecol Oncol 1252): 362 -366.

o Suidan, R. S., P. T. Ramirez, et al. 2014). "A multicenter prospective trial evaluating the ability of preoperative computedtomography scan and serum CA-125 to predict suboptimal cytoreduction at primary debulking surgery for advanced ovarian,fallopian tube, and peritoneal cancer." Gynecol Oncol 1343): 455 -461.

o Testa, A. C., M. Ludovisi, et al. 2012). "Ultrasound evaluation of intra -abdominal sites of disease to predict likelihood of suboptimalcytoreduction in advanced ovarian cancer: a prospective study." Ultrasound Obstet Gynecol 391): 99 -105.

o Yavuzcan, A., A. Baloglu, et al. 2009). "The investigation of the factors affecting retroperitoneal lymph node metastasis in stage IIICand IV epithelial ovarian cancer." Arch Gynecol Obstet 2806): 939 -944.



16


PRETREATMENT MULTIDISCIPLINARY DECISION-MAKING PROCESS


Title provided by Gagliardi et al. 2005 : Proportion of institutions offering care to ovarian cancer patients withmultidisciplinary decision-making processes.

Title provided by Querleu et al. 2013): Formal pretreatment multidisciplinary approach before any decision forlaparotomy or neoadjuvant chemotherapy. If neoadjuvant chemotherapy is proposed, a biopsy under radiologic orlaparoscopic guidance is mandatory.

Title provided by NHS 2013): Treatment planned and reviewed at a multi-disciplinary team meeting. Patients withepithelial ovarian cancer should be discussed by a multidisciplinary team (MDT prior to definitive treatment.

DESCRIPTION.


Description provided by Querleu et al. 2013): The initial decision for immediate surgery or neoadjuvantchemotherapy should be taken jointly by at least a surgeon and a medical oncologist during a formal multidisciplinaryTumour Board meeting. If primary surgery is carried out, a second Tumour Board is indicated with the knowledge ofpathological diagnosis and final staging. One of these meetings must also involve a pathologist and radiologist.

Description provided by NHS 2013): Proportion of patients with epithelial ovarian cancer who are discussed at aMDT meeting before definitive treatment.


Specifications provided by Gagliardi et al. 20 05 : Not specified.


Specifications provided by NHS (2013):

o Numerator: Number of patients with epithelial ovarian cancer discussed at the MDT before definitive treatment.

o Denominator: All patients with epithelial ovarian cancer.o Exclusions: Patients who died before first treatment.

TARGET.

Target provided by Gagliardi et al. 20 05 : Not specified.

Target provided by Querleu et al. 2013) : 100% of patients will be discussed before a decision is made.

Target provided by NHS 2013): 95%. The tolerance within this target accounts for situations where patients requiretreatment urgently.



o Hoskins, W., Rice, L. and Rubin, S. 1997). Ovarian cancer surgical practice guidelines. Society of Surgical Oncology practic eguidelines. Oncology Williston Park , 116): 896 -900, 903-4.

References provided by Querleu et al. 2013) :

o Burton, E., D. Chase, et al. 2011). "Surgical management of recurrent ovarian cancer: the advantage of collaborative surgicalmanagement and a multidisciplinary approach." Gynecol Oncol 1201): 29 -32.

o Ray-Coquard, I, et al. 2004). Conformity to clinical practice guidelines, multidisciplinary management and outcome of treatment forsoft tissue sarcomas. Ann Oncol 152): 307 -15.

o Wilcoxon, H., K. Luxford, et al. 2011). "Multidisciplinary cancer care in Aust ralia: a national audit highlights gaps in care andmedico-legal risk for clinicians." Asia Pac J Clin Oncol 71): 34 -40.



17


PRETREATMENT MULTIDISCIPLINARY DECISION-MAKING PROCESS


References provided by NHS 2013):

o NHS. 2008). Management of Core Cancer Services Stan dards accessed on 5 August 2013).http://www?healthcareimprovementscotland.org/our_work/cancer_care_improvement/cancer_resources/standards_for_cancer_services.aspx.


o SIGN 2013). "Management of epithelial ovarian cancer." http://www.sign.ac.uk/pdf/sign135.pdf.



18


ANAESTHETIC MANAGEMENT


Title provided by Querleu et al. 2013): Pre-, intra-, and post-operative anaesthetic management.

DESCRIPTION.

Description provided by Querleu et al. 2013): This criterion is defined in compliance with the recommendationsadopted by the French Society of Anaesthesia Intensive Care SFAR, the French Society of Digestive Surgery, and theFrench Society of Parenteral and Enteral Nutrition. Eight indicators were selected and classifed spefically from AR1 toAR8. In preoperative management, two indicators are used: presence of a nutritional assessment and nutritionaloptimization with a minimum of seven days of enteral nutritional supplementation in cases of peritonealcarcinomatosis. Intraoperative management must include antibiotic prophylaxis before skin incision, hemodynamicmonitoring, and the administration of at keast two different classes of antiemetics. In the postoperative period,thromboprophylaxis with low molecular weight heparin for at least 4 weeks is required. The use of epidural analgesiapreoperatively is suggested to contribute to the optimization of pain control as an integral part of postoperativerehabilitation, including physiotherapy, early deambulation, and rapid oral feeding, aiming at promoting a decease inpostoperative morbidity and duration of hospital stay.



TARGET.

Target provided by Querleu et al. 2013) : 100% of surgical care for stage IIIc and IV ovarian cancers will confirm tothese recommendations.



o Atkins, D et al. 2004). Grading quality of evidence and strength of recommendations. BMJ 3287454): 1490.




19


MIDLINE LAPAROTOMY


Title provided by Querleu et al. 2013): Midline laparotomy (xipho-pubic.

DESCRIPTION.

Description provided by Querleu et al. 2013): Laparotomy extending from the xiphoid process to the pubic region.



TARGET.

Target provided by Querleu et al. 2013) : 0% transverse or low midline laparotomies.







20


PELVIC AND PARA-AORTIC LYMPHADENECTOMY


Title provided by Verleye et al. 2009): % of debulking operations including a pelvic and para-aorticlymphadenectomy when otherwise complete debulking has been achieved.

Title provided by Querleu et al. 2013): Performing a pelvic and para-aortic lymphadenectomy in cases of completecytoreduction.

DESCRIPTION.


Description provided by Querleu et al. 2013): Complete dissection extending from the femoral rings to the left renalvein. Sampling is not accepted as standard.


Specifications provided by verleye et al. 2009): Not specified.


TARGET.

Target provided by Verleye et al. 2009): ≥ 90%.

Target provided by Querleu et al. 2013) : 100% complete lymphadenectomy.



o Burghardt, E. Girardi, F., Lahousen, M., Tamussino, K. and Stettner, H. 1991). Patterns of pelvic and paraaortic lymph nodeinvolvement in ovarian cancer. Gynecol Oncol 402): 103 -6.

o Chan, J.K. et al. 2007). The potential therapeutic role of lymph node resection in epithelial ovarian cancer: a study of 13918patients. Br J Cancer 9612): 1817 -22.

o Du Bois, A. and Harter, P. 2006). The role of surgery in advanced and recurrent ovarian cancer. Ann Oncol 17Suppl 10): x235 -40.o Du Bois, A. Reuss, A. and Harter, P. et al. 2006). The role of lymphadenectomy in advanced epithelial ovarian cancer AOC in

patients with macroscopically complete resection of intraperitoneal disease. Int J Gynecol Cancer 16Suppl.: 599 -615. Abstract 008.o Eisenkop, S.M. and Spirtos, N.M. 2001). The clinical significance of occult macroscopically positive retroperitoneal nodes i n patients

with epithelial ovarian cancer. Gynecol Oncol 821): 14 3-9.o Fukasawa, H. et al. 1995). Lymphadenectomy in stage -III serous cystadenocarcinoma of the ovary. Int Gynaecol Obstet 513): 239 -

45.

o Harter, P et al. 2007). Pattern and clinical predictors of lymph node metastases in epithelial ovarian cancer. Int J Gynecol Cancer176): 1238 -44.

o Morice, P., Pautier, P., Lhomme, C. and Castaigne, D. 2005). Re: Systematic aortic and pelvic lymphadenectomy versus resecti on ofbulky nodes in optimally debulked advanced ovarian cancer : a randomized clinical trial. J Natl Cancer Inst 9711): 1620 -1; authorreply 1621-3.

o Panici, P.B. et al. 2005). Systematic aortic and pelvic lymphadenectomy versus resection of bulky nodes only in optimally debulkedadvanced ovarian cancer : a randomized clinical trial. J Natl Cancer Inst 978):560 -6.

o Pereira, A. Magrina, J.F., Rey, V., Cortes, M. and Magtibay, P.M. 2007). Pelvic and aortic lymph node metastasis in epitheli al ovariancancer. Gynecol Oncol 1053): 604 -8.

o Querleu, D. and Ferron, G. 2005). Re: Systematic aortic and pelvic l ymphadenectomy versus resection of bulky nodes in optimallydebulked advanced ovarian cancer: a randomized clinical trial. J Natl Cancer Inst 97(21): 1621; author reply 1621-3.

o Scarabelli, C. et al. 1997). Systematic pelvic and para -aortic lymphadenectomy in advanced ovarian cancer patients with no residualintraperitoneal disease. Int J Gynecol Cancer 71): 18 -26.

o Spirtos, N.M., gross, G.M., Freddo, J.L. and Ballon, S.C. 1995). Cytoreductive surgery in advanced epithelial cancer of the ovary: theimpact of aortic and pelvic lymphadenectomy. Gynecol Oncol 563): 345 -52.



21


PELVIC AND PARA-AORTIC LYMPHADENECTOMY





o Abe, A., H. Furumoto, et al. 2010). "The impact of systematic para -aortic and pelvic lymphadenectomy on survival in patients withoptimally debulked ovarian cancer." J Obstet Gynaecol Res 365): 1023 -1030.

o Aletti, G. D., S. Dowdy, et al. 2006). "Role of lymphadenectomy in the management of grossly apparent advanced stage epithelialovarian cancer." Am J Obstet Gynecol 1956): 1862 -1868.

o Angioli, R., F. Plotti, et al. 2008). "Update on lymphadenectomy in early and advanced ovar ian cancer." Curr Opin Obstet Gynecol201): 34 -39.

o Chang, S. J., R. E. Bristow, et al. 2012). "Prognostic significance of systematic lymphadenectomy as part of primary debulkingsurgery in patients with advanced ovarian cancer." Gynecol Oncol 1263): 381 -386.

o Dell' Anna, T., M. Signorelli, et al. 2012). "Systematic lymphadenectomy in ovarian cancer at secondlook surgery: a randomisedclinical trial." Br J Cancer 1075): 785 -792.

o du Bois, A., A. Reuss, et al. 2010). "Potential role of lymphadenectomy in advanced ovarian cancer: a combined exploratory analysisof three prospectively randomized phase III multicenter trials." J Clin Oncol 2810): 1733 -1739.

o Fagotti, A., P. De Iaco, et al. 2012). "Systematic pelvic and aortic lymphadenectomy in advanced ovar ian cancer patients at the timeof interval debulking surgery: a double-institution case-control study." Ann Surg Oncol 1911): 3522 -3527.

o Gonzalez Martin, A., A. Redondo, et al. 2013). "GEICO Spanish Group for Investigation on Ovarian Cancer treatment guidelines inovarian cancer 2012." Clin Transl Oncol 157): 509 -525.

o Kim, H. S., W. Ju, et al. 2010). "Systematic lymphadenectomy for survival in epithelial ovarian cancer: a meta -analysis." Int JGynecol Cancer 204): 520 -528.

o Ledermann, J. A., F. A. Raja, et al. 2013). "Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical PracticeGuidelines for diagnosis, treatment and follow-up." Ann Oncol 24 Suppl 6: vi24-32.



22


DEBULKING OPERATION


Title provided by Verleye et al. 2009): % of debulking operations including a hysterectomy, bilateral salpingo-oophorectomy and infracolic omentectomy when the surgeon considers optimal debulking feasible.

DESCRIPTION.



Specifications provided by Verleye et al. 2009): Not specified.

TARGET.



References provided by Verleye et al. 2009): Not specified.


o AHS 2013). "Epithelial ovarian, fallopian tube, and primary peritoneal cancer. " http://www.albertahealthservices.ca/hp/if-hp-cancer-guide-gyne005-epithelialovarian.pdf.




23


PATHOLOGY REPORT


Title provided by Gagliardi et al. 2005): Proportion of patients having undergone ovarian cancer surgery whosepathology report includes weight and measurement of all samples; detailed macroscopic description of all excisedpieces; multiple samples from all ovarian lesions; description of any extra-ovarian spread; histological type; anddegree of differentiation.

Title provided by Querleu et al. 2013): Minimum required elements in pathology reports.

Title provided by NHS 2013: Histopathology reports are complete and support clinical decision-making.Histopathology reports relating to pelvic clearance surgery for patients with epithelial ovarian cancer contain allnecessary information to inform treatment decision making.

DESCRIPTION.


Description provided by Querleu et al. 2013): Standardized reporting (INCa, 2011).

Description provided by NHS 2013): Proportion of patients with epithelial ovarian cancer undergoing pelvicclearance surgery having a complete pathology report as defined by the Royal College of Pathologists.



Specifications provided by Querleu et al. 2013 : Not specified.


o Numerator: Number of patients with epithelial ovarian cancer undergoing definitive cytoreductive surgery who have a completepathology report that contains all data items as defined by the Royal College of Pathologists.

o Denominator: All patients with epithelial ovarian cancer undergoing definitive cytoreductive surgery.o Exclusions: No exclusions.

TARGET.


Target provided by Querleu et al. 2013 : 100% of reports will contain the minimally required elements.

Target provided by NHS 2013: 90%. The tolerance within this target reflects situations where it is not possible toreport all components of the data set due to poor quality of specimen.



o Kerbrat, P. et al. 2001). Ovarian can cer. Br J Cancer 84Suppl2): 18 -23.

References provided by Querleu et al. 2013 :

o INCa 2011). Mise à jour 2011 des comptes rendus d’anatomopathologie: données minimales à renseigner pour une tumeurprimitive. http://www.e-cancer.fr/component/docman/doc_download/4085-comptes-rendus-danatomopathologie--donnees-minimales-a-renseigner-pour-une-tumeur-primitive.



24


PATHOLOGY REPORT


References provided by Querleu et al. 2013 continued :

o INCa 2011). Mise à jour 2011 des comptes rendus d’anatomopathologie: données minimales à renseigner pour une tumeurprimitive. http://www.e-cancer.fr/component/docman/doc_download/4085-comptes-rendus-danatomopathologie--donnees-minimales-a-renseigner-pour-une-tumeur-primitive.

o Malpica, A. 2008). Grading of ovarian cancer: a histotype -specific approach. Int J Gynecol Pathol 272): 175 -81.o Scully, R.E., Henson, D.E., Nielsen, M.L. and Ruby, S.G. 1996). Practice protocol for the examination of specimens removed f rom

patients with ovarian tumors. A basis for checklists. Members of the Cancer Committee, College of American Pathologists, TaskForce on the Examination of Specimens Removed from Patients with Ovarian Tumors. Cancer 784): 927 -40.

o Soslow, R.A. 2008). Hist ologic subtypes of ovarian carcinoma: an overview. Int J Gynecol Pathol 272): 161 -74.

o Verleye, L., P. B. Ottevanger, et al. 2011). "Quality of pathology reports for advanced ovarian cancer: are we missing essen tialinformation? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial." Eur J Cancer 471):57-64.


o RCP. 2010). Datasets for the histopathological reporting of neoplasms of the ovaries and fallopian tubes and primary carcino mas ofthe peritoneum 3 rd edition accessed on 5 august 2013).http://www.rcpath.org/Resources/RCPath/Migrated%20Resources/Documents/G/g079ovariandatasetnov10.pdf.




25


OPERATIVE REPORT


Title provided by Gagliardi et al. 2005): Proportion of patients having undergone surgery for ovarian cancer whoseoperative report includes initial findings; all operative procedures; and size and location of residual disease.

Title provided by Verleye et al. 2009): % of debulking operations for which the size and location of residual diseaseat the end of the operation is documented in the operation notes. % of patients undergoing debulking surgery withthe spread of disease fully assessed for operability at the start of surgery and initial findings documented in theoperation notes.

Title provided by Querleu et al. 2013): Analytical description of initial peritoneal lesions and residual lesions in allsegments of the abdomen.

DESCRIPTION.



Description provided by Querleu et al. 2013): Structured description of the initial and, if applicable, residual lesions.The use of validated scales, such as the Peritoneal Cancer Index and Completeness of cytoreduction CC), isrecommended.



Specifications provided by Verleye et al. 2009): Not specified.

Specifications provided by Querleu et al. 2013 : Not specified.

TARGET.



Target provided by Querleu et al. 2013 : 100% of reports are organized by anatomical regions and contain adescription of the initial and, if any, residual lesions after cytoreductive surgery.



o 1998). ACOG educational bulletin. Ovarian cancer. Number 250, August 1998 replaces No. 141, May 1990). American College ofObstetricians and Gynecologists. Int J Gynaecol Obstet 633): 301 -10.

References provided by Verleye et al. 2009 :

o Gagliardi, A.R., Fung Kee Fung, M., Langer, B., Stern, H. and Brown, A.D. 2005). Development of ovarian cancer surgery quali tyindicators using a modified Delphi approach. Gynecol Oncol 972): 446 -56.

References provided by Querleu et al. 2013 :

o Bakrin, N., E. Cotte, et al. 2012). "Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy HIPEC for persistent andrecurrent advanced ovarian carcinoma: a multicenter, prospective study of 246 patients." Ann Surg Oncol 1913): 4052 -4058.

o Eisenkop, S.M. et al. 2003). Relative influences of tumor volume before surgery and the cytoreductive outcome on survival forpatients with advanced ovarian cancer: a prospective study. Gynecol Oncol 902): 390 -6.

o Elit, L., S. Bondy, et al. 2006). "The quali ty of the operative report for women with ovarian cancer in Ontario." J Obstet GynaecolCan 2810): 892 -897.



26


OPERATIVE REPORT


References provided by Querleu et al. 2013 continued :

o Gillman, L. M., A. Vergis, et al. 2010). "Structured operative reporting: a ran domized trial using dictation templates to improveoperative reporting." Am J Surg 1996: 846 -850.

o Gogoi, R. P., R. Urban, et al. 2012. "Evaluation of Society of Gynecologic Oncologists SGO ovarian cancer quality surgicalmeasures." Gynecol Oncol 126 2): 217-219.

o Gonzalez-Moreno, S. Kusamura, S. Baratti, D. and Deraco, M. 2008). Postoperative residual disease evaluation in the locoregionaltreatment of peritoneal surface malignancy. J Surg Oncol 984): 237 -41.

o Harvey, A. Zhang, H., Nixon, J. and Brown, C.J. 2007). Comparison of data extraction from standardized versus traditional narrativeoperative reports for database-related research and quality control. Surgery 1416): 708 -14.

o Portilla, A.G., Shigeki, K. Dario, B. and Marcello, D. 2008). The intr aoperative staging systems in the management of peritonealsurface malignancy. J Surg Oncol 984: 228 -31.

o Tentes, A.A. 2003). Peritoneal cancer index: a prognostic indicator of survival in advanced ovarian cancer. Eur J Surg Oncol 291):69-73.





27


INTRAOPERATIVE FROZEN SECTIONS


Title provided by Querleu et al. 20 13: Possibility of frozen section at the time of surgical intervention.

DESCRIPTION.

Description provided by Querleu et al. 20 13: A pathologist can be consulted intraoperatively.


Specifications provided by Querleu et al. 20 13 : Not specified.

TARGET.

Target provided by Querleu et al. 20 13: All institutions ensure access to facilities for frozen sections.


References provided by Querleu et al. 20 13:

o Akrivos, N. Thomakos, N. Sotiropoulou, M, Rodolakis, A. and Antsaklis, A. 2010). Intraoperative consultation in ovarian pathology.Gynecol Obstect Invest 703): 193 -9.

o Baker, P and Oliva, E. 2008). A practical approach to intraoperative consultation in gynecological pathology. Int J Gynecol Pathol273) : 353-65.





28

4.3. Outcome indicators


COMPLETE SURGICAL RESECTION


Title provided by Gagliardi et al. 2005): Proportion of patients with advanced stage ovarian cancer undergoingsurgery who receive optimal debulking (less than 1 cm residual.

Title provided by Verleye et al. 2009): % of debulking operations for advanced ovarian cancer at the end of whichcomplete cytoreduction, defined as no macroscopic residual disease at the end of the operation, was achieved.

Title provided by Querleu et al. 2013): Rate of complete surgical resection either at initial surgery or afterneoadjuvant chemotherapy.

Title provided by NHS 2013: No macroscopic residual disease following surgery for advanced disease. Surgery, asfirst definitive treatment, for patients with advanced epithelial ovarian cancer FIGO Stage 2 or higher should achieveno macroscopic residual disease. Delayed primary surgery. Delayed primary surgery, after neo-adjuvantchemotherapy for advanced epithelial ovarian cancer FIGO Stage 3c or 4), should achieve optimal cytoreduction <1cm.

Title provided by Wagner et al. 2013): Macroscopically complete resection of advanced ovarian cancer.

DESCRIPTION.



Description provided by Querleu et al. 2013): Complete surgical resection is defined by the absence of remainingmacroscopic lesions in all quadrants after careful exploration of the abdomen.

Description provided by NHS 2013): Proportion of patients with advanced epithelial ovarian cancer FIGO Stage 2 orhigher final stage of disease as agreed by MDT who have <1 cm residual disease and those who have nomacroscopic residual disease following surgery. Proportion of patients with advanced epithelial ovarian cancer FIGOStage 3c or 4) having delayed primary surgery following neo-adjuvant chemotherapy and where optimalcytoreduction is achieved.

Description provided by Wagner et al. 2013): The goal of primary surgery must be to achieve macroscopicallycomplete resection.



Specifications provided by Verleye et al. 2009) : Not specified.




29



SPECIFICATIONS numerator 1, denominator2, exclusions . continued


o Numerator: i Number of patients with advanced epithelial ov arian cancer FIGO Stage 2 or higher with no macroscopic residualdisease following surgery. ii Number of patients with advanced epithelial ovarian cancer FIGO Stage 2 or higher undergoingsurgery with macroscopic residual disease <1 cm. iii Number of patients with advanced epithelial ovarian cancer FIGO Stage 3c or4) undergoing delayed primary surgery after neo-adjuvant chemotherapy. iiii Number of patients with advanced epithelial ovariancancer FIGO Stage 3c or 4) undergoing delayed primary s urgery with residual disease <1 cm.

o Denominator: i ii All patients with advanced epithelial ovarian cancer FIGO Stage 2 or higher undergoing surgery. i ii Allpatients with advanced epithelial ovarian cancer FIGO Stage 3c or 4) having neo -adjuvant chemotherapy. ii ii All patients withadvanced epithelial ovarian cancer FIGO Stae 3c or 4) undergoing delayed primary surgery after neo -adjuvant chemotherapy.

o Exclusions: i ii Patients with FIGO Stage 4 disease. iii iiii No exclusions.

Specifications provided by Wagner et al. 2013):

o Numerator: Number of patients with macroscopically complete resection.o Denominator: All patients with a primary diagnosis of ovarian cancer ≥ FIGO IIB and surgical removal of the tumour.o Exclusions: Not specified.

TARGET.

Target provided by Gagliardi et al. (2005): Not specified.


Target provided by Querleu et al. 2013): The target of complete resection CC -O is set to 100% for stage I to IIIb and70% for stage IIIc and IVa.

Target provided by NHS 2013): i 30%. The tolerance within this target accounts for the fact that due to widespreadinvolvement of peritoneal surfaces, bowel mesentery and serosa of bowel in the majority of patients with advancedepithelial ovarian cancer it is frequently not possible to resect all visible disease. ii 60%. The tolerance within thetarget accounts for the fact that although the objective of surgery is to resect all visible disease, on occasions wherethis is not possible because of widespread involvement of peritoneal surfaces, bowel mesentery and serosa of bowel,the objective should be to achieve optimal cytoreduction, with macroscopic disease <1 cm. i ii 75%. The tolerancesallowed by the target set reflect variance in individual patient response to chemotherapy, treatment associatedmorbidities and impact of these on individual patient fitness for surgery. i iii 65%. The tolerances allowed by thetarget set reflect variance in individual patient response to chemotherapy.

Target provided by Wagner et al. 2013): Macroscopically complete resection to be achieved as often as possible.



o 1998). ACOG educational bulletin. Ovarian cancer. Number 250, August 1998 replaces No. 141, May 1990). American College ofObstetricians and Gynecologists. Int J Gynaecol Obstet 633): 301 -10.

o Allen, D.G. et al. 1993). Advanced epithelial ovarian cancer: 1993 consensus statements. Ann Oncol 4Suppl 4): 83 -8.

o Bosze, P. et al. 2000). Consensus statements on prognostic factors in epithelial ovarian carcinoma. Report of the ConsensusMeeting organized by the European Society of Gynaecological Oncology, ESGO. Eur J Gynaecol Oncol 215): 513 -26.

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35


PROSPECTIVE REPORTING OF COMPLICATIONS


Title provided by Gagliardi et al. 2005): Proportion of ovarian cancer patients experiencing significant morbidityduring the first 28 days following surgery.

Title provided by Querleu et al. 2013): Existence of a structured prospective reporting of complications within 30days postoperatively.

DESCRIPTION.


Description provided by Querleu et al. 2013): Data to be recorded are reoperations, interventional radiology,readmissions, prolonged hospitalization, transfers to intensive care unit, and deaths.




TARGET.


Target provided by Querleu et al. 2013): 100% of the complications should be recorded and reviews conducted formore serious complications and when a death has occurred.


References provided by Gagliardi et al. 2005): this indicator was proposed by the panel and not extracted from themedical literature.


o Clavien, P.A. and Dindo, D. 2009). Classification of Surgical Complications.http://www.surgicalcomplication.info/templates_download.html.

o Dindo, D. Hahnloser, D. and Clavien, P.A. 2010). Quality assessment in surgery: riding a lame horse. Ann Surg 251(4): 766-71.




36

5. APPENDIX A: COMPLEMENTARY BIBLIOGRAPHIC SEARCHThe literature search was conducted using the following strategy: Queries using the Medline database were carried out with search equations:

o #1: “quality indicators” AND “ovarian cancer”;o #2: “guidelines” AND “ovarian cancer” AND “surgery”;o #3: “surgery” AND “ovarian cancer”;o #4: “guidelines” AND “ovarian cancer” .

The bibliographic search strategy was limited to references in English and French publishedbetween January 1st 2005 and February 17th 2015;

The bibliography will also be supplemented by references suggested by the experts of theworking group.

The references presented in the appendix B were identified with this complementary bibliographicsearch but were not selected as potential additional references to complete original bibliography ofthe quality indicators identified.

6. APPENDIX B: OTHER REFERENCES CONSULTED2006). "Chemotherapy delivered into abdomen may extend ovarian cancer survival." Mayo Clin WomensHealthsource 106): 3.

2006). "I've been told I may have ovarian cancer and am to undergo surgery. Does it matter what type ofsurgeon I have?" Mayo Clin Womens Healthsource 109: 10.

2007). "Radiotherapy appears effective in inhibiting ovarian cancer spread." Duke Med Health News 131: 10.

2008). "[Standards, Options: Recommendatio ns for the management of patients with epithelial ovariancancer. Medical front-line treatment summary report, update 2008)]." Gynecol Obstet Fertil 366): 684 -700.

2009). "Patient information. Ovarian cancer." Am Fam Physician 806): 609 -s601.

2010). " NewsCap: Younger women with early-stage ovarian cancer can keep the healthy ovary and uterus."Am J Nurs 1101: 20.

2010). "U S. Medical Eligibility Criteria for Contraceptive Use, 2010." MMWR Recomm Rep 59RR -4): 1-86.

2011). "Committee Opinion No. 477 : the role of the obstetrician-gynecologist in the early detection ofepithelial ovarian cancer." Obstet Gynecol 1173): 742 -746.

2011). "New guidelines for early detection of ovarian cancer." Lancet 3779777): 1544.

2012). "USPSTF says no screening for ovarian cancer in new guidelines." Oncology Williston Park 2610): 896,928.

2013). "Bevacizumab and advanced -stage ovarian cancer. Yet another oncological indication, but still best toavoid using this drug." Prescrire Int 22136: 64 -67.

2015). "Comm ittee opinion no. 620: salpingectomy for ovarian cancer prevention." Obstet Gynecol 1251):279-281.

Aarts, F., R. P. Bleichrodt, et al. 2008). "Intracavitary radioimmunotherapy to treat solid tumors." CancerBiother Radiopharm 231: 92 -107.


37

Abaid, L. N., B. H. Goldstein, et al. 2010. "Improved overall survival with 12 cycles of single -agent paclitaxelmaintenance therapy following a complete response to induction chemotherapy in advanced ovariancarcinoma." Oncology 785 -6): 389-393.

Abascal-Saiz, A., L. Sotillo-Mallo, et al. 2014). "Management of borderline ovarian tumours: a comprehensivereview of the literature." Ecancermedicalscience 8: 403.

Abbas, A. M. 2014). "A new scoring model for characterization of adnexal masses based on two -dimensionalgray-scale and colour Doppler sonographic features." Facts Views Vis Obgyn 62): 68 -74.

Abdallah, R., H. S. Chon, et al. 2014). "Gene expression and prediction of complete cytoreduction in ovariancancer." Obstet Gynecol 123 Suppl 1: 89S.

Abdel-Azeez, H. A., H. A. Labib, et al. 2010). "HE4 and mesothelin: novel biomarkers of ovarian carcinoma inpatients with pelvic masses." Asian Pac J Cancer Prev 111): 111 -116.

Abdul, S., J. A. Tidy, et al. 2006). "Can we identify the patients who are likely to undergo bowel resection at thetime of surgery for ovarian cancer?" J Obstet Gynaecol 264: 357 -362.

Abe, A., T. Minaguchi, et al. 2013). "PIK3CA overexpression is a possible prognostic factor for favorable survivalin ovarian clear cell carcinoma." Hum Pathol 442): 199 -207.

Abood, G., M. Bowen, et al. 2008). "Hepatic resection for recurrent metastatic ovarian cancer." Am J Surg1953): 370 -373; discussion 373.

Abu, J., L. Brown, et al. 2006). "Mesovarian hemangioma presenting as massive ascites, pelvic mass, andelevated CA125." Int J Gynecol Cancer 16 Suppl 1: 412-414.

Abu Saadeh, F., L. Norris, et al. 2013). "Venous thromboembolism in ovarian cancer: incidence, risk factors andimpact on survival." Eur J Obstet Gynecol Reprod Biol 1701: 214 -218.

Abubaker, K., R. B. Luwor, et al. 2014). "Targeted Disruption of the JAK2/STAT3 Pathway in Combination withSystemic Administration of Paclitaxel Inhibits the Priming of Ovarian Cancer Stem Cells Leading to a ReducedTumor Burden." Front Oncol 4: 75.

Abu-Musa, A., M. Seoud, et al. 2008). "In vitro fertilization in a patient with ovarian cancer stage IC followingconservative surgery and chemotherapy: a case report." Eur J Gynaecol Oncol 294): 408 -410.

Achimas-Cadariu, P., A. Irimie, et al. 2009). "Could serol ogic and ultrasonographic indexes be useful fortherapeutic decisions in patients with ovarian cancer?" Chirurgia Bucur) 1043): 287 -293.

Achir, A., M. Mahdi, et al. 2010). "[Filling of the thymic space after chemotherapy for ovarian cancer]." Rev MalRespir 279): 1101 -1104.

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guidelines.esgo.org | [email protected] Published October 2016 by European Society of Gynaecological OncologyCopyrights: © European Society of Gynaecological OncologyESGO Advanced Ovarian Cancer Surgery Quality Indicators - Description of Quality Indicators - Rating 1_v1