Quality assurance in melanoma surgery: The evolving experience at a large tertiary referral centre

Quality assurance in melanoma surgery: The evolving experience at a large tertiary referral centre

Accepted Manuscript Quality assurance in melanoma surgery: the evolving experience at a large tertiary referral centre Rebecca L. Read, MBBS DPhil, Sa...

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Accepted Manuscript Quality assurance in melanoma surgery: the evolving experience at a large tertiary referral centre Rebecca L. Read, MBBS DPhil, Sandro Pasquali, MD, Lauren Haydu, BSCHE MIPH, John F. Thompson, MD, Jonathan R. Stretch, MBBS DPhil, Robyn PM. Saw, MBMS, Michael J. Quinn, MBBS, Kerwin Shannon, MBBS, Andrew J. Spillane, MD PII:

S0748-7983(14)01288-8

DOI:

10.1016/j.ejso.2014.12.003

Reference:

YEJSO 3955

To appear in:

European Journal of Surgical Oncology

Received Date: 13 October 2014 Revised Date:

24 November 2014

Accepted Date: 6 December 2014

Please cite this article as: Read RL, Pasquali S, Haydu L, Thompson JF, Stretch JR, Saw RP, Quinn MJ, Shannon K, Spillane AJ, Quality assurance in melanoma surgery: the evolving experience at a large tertiary referral centre, European Journal of Surgical Oncology (2015), doi: 10.1016/j.ejso.2014.12.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT

Quality assurance in melanoma surgery: the evolving experience at a large tertiary referral centre Rebecca L Reada,b MBBS DPhil, Sandro Pasqualic MD, Lauren Haydua BSCHE MIPH,

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John F Thompsona,b,d MD, Jonathan R Stretcha,b,d MBBS DPhil, Robyn PM Sawa,b,d MBMS, Michael J Quinna,b,d MBBS, Kerwin Shannon MBBSa,b and Andrew J Spillane

a

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MDa,b,d

Melanoma Institute Australia, Sydney, NSW, Australia; bRoyal Prince Alfred Hospital,

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Sydney, NSW, Australia; cDepartment of Oncological and Surgical Sciences, University of Padova, Padova, Italy; dDiscipline of Surgery, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.

Correspondence

Andrew J Spillane MD

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Melanoma Institute Australia, Poche Centre 40 Rocklands Rd

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North Sydney, NSW, 2060 Australia

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Telephone: 61 (0)2 9911 7250 Fax: 61 (0)2 9954 9938 Email: [email protected]

ACCEPTED MANUSCRIPT Abstract Background The quality of melanoma surgery needs to be assessed by oncological outcome and complication rates. There is no published consensus on complication rates for common

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melanoma surgeries, namely wide excision (WE), sentinel node biopsy (SNB) and

regional lymph node dissection (RLND). Consequently there are no agreed standards by which surgeons can audit their practices.

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Methods

Surgical standards were proposed in 2008 following review of the literature and from

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expert opinion. Melanoma Institute Australia (MIA) self-reported audit data from 2011 and 2012 were compared with these standards. To quality check the self-reported audit, RLND data were extracted from the MIA database. Results

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Six surgeons performed a mean of 568 surgeries each quarter; with a mean of 106 major procedures. Following WE with primary closure or flap repair, wound infection or dehiscence occurred in <1% of cases. When skin grafting was required non-take of

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>20% of the grafted area was observed in 5.9% of cases. Following SNB wound infection and significant seroma occurred in 1.8% of cases. RLND node counts were

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below the 90% standard in 5 of 409 procedures. In comparison, data extraction identified 405 RLNDs, with node counts below the 90% standard in eight procedures. Two of these patients had previously undergone surgery removing nodes from the field and two had gross coalescing disease with extensive extra-nodal spread. Conclusion The quality standards proposed in 2008 have been validated long-term by high volume caseloads. The data presented provide standards by which melanoma surgeons can audit their surgical performance.

ACCEPTED MANUSCRIPT Key words Quality assurance, health care Surgery Melanoma

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Sentinel lymph node biopsy

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Lymph node dissection

ACCEPTED MANUSCRIPT Introduction Surgery is the mainstay of treatment for patients with primary melanomas and also for those with regional metastatic disease. The most common operations performed are: wide excision (WE) of the primary site, sentinel node biopsy (SNB) and regional lymph

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node dissection (RLND).

WE of a primary melanoma aims to achieve local control and results in cure in most

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cases. Recommendations for excision margins have been extensively reported.[1]

Wound closure after WE is either: primarily, by split or full thickness skin grafting (SG)

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or by flap repair using a variety of methods. The method of wound closure varies depending on the width of resection (usually 1-2 cm), anatomic location and local tissue characteristics. SNB is used as a staging procedure in patients with primary melanomas ≥1 mm in Breslow thickness or other adverse features with clinically (and ultrasound)

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negative regional node fields.[2, 3] RLND is currently the recommended treatment for patients who have clinically apparent, biopsy-proven regional node melanoma metastases or a positive SNB, except in the setting of a clinical trial or if the patient is unfit for

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surgery. The second Multicentre Selective Lymphadenectomy Trial (MSLT II) is currently assessing the role of RLND in SNB-positive patients.[4] Surgery is also used in

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a heterogeneous and highly selected population of patients with distant metastatic disease.[5]

It has been known for many years, and reported in numerous studies of patients with melanoma [6] and other malignancies [7, 8], that a link exists between the quality of surgery and patient outcomes for both improved local disease control and overall survival. A number of national guidelines, including the Australian and New Zealand Melanoma Management Guidelines and the National Comprehensive Cancer Network

ACCEPTED MANUSCRIPT (NCCN) recommendations, are available and detail the expected principles of care in melanoma patients.[9,10] An EORTC Melanoma Group Survey concluded that the adequacy of surgery was most important in the management of local and regional melanoma but demonstrated significant variability in the extent of surgery utilised across

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centres [11]. The Cancer Program of the American College of Surgeons has validated a series of 26 quality indicators to assess the standards of melanoma care in hospitals

across the United States with the aim of improving adherence to clinical guidelines.[12]

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However, the provision of guidelines does not necessarily ensure that the quality of

surgery is satisfactory. Even if the surgeon follows guidelines all the time the surgery

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must be performed with the necessary skill and attention to provide optimum cancer control with minimal morbidity. The question remains: what are the expected or acceptable complication rates for these frequently performed operations?

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Long-term oncological outcomes are clearly of primary importance but they cannot be used routinely by surgeons to audit and improve their clinical practice. The process of audit is by definition a systematic critical analysis of the quality of medical care in which

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standards are defined and data are collected against these standards.[13] Presentation of data allows either improvement or monitoring with the aim of improving patient

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outcomes. As yet there is no published consensus on surgical performance indicators and complication rates in melanoma surgery. Consequently, there are no standards with which individual surgeons and units can compare their own audited outcomes.

This study presents a panel of indicators that was established by review of the literature and expert opinion with the aim of evaluating the quality of treatment delivered by surgeons within our institution. After a period of maturation of the audit cycle (20092010), these self-reported audit data collected for 2011-2012 were compared against the

ACCEPTED MANUSCRIPT indicators proposed in 2008. In addition, the quality of self-reported regional lymph node dissection data was confirmed by comparison with information collected independently by data managers for the Melanoma Institute Australia (MIA) database.

This study was approved by the MIA Research Committee.

Establishing Baseline Quality Parameters

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Methods

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Potential indicators of surgical performance were identified from literature review and

expert opinion. Consensus on quality thresholds was obtained from six surgeons who

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comprised the general and plastic and reconstructive surgical service at MIA during the period of the study. Data reporting was required on surgeon workload, operative complications for any type of surgery (Key Performance Indicators, KPIs), and a series of proposed Melanoma Surgery Specific Performance Indicators (MSSPIs). These are



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summarized in Table 1.

Wide excision is usually a clean surgical procedure. Surgical site infections

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(SSIs) occurred within 30 days of surgery and were diagnosed by the surgeon or a treating physician with or without laboratory confirmation. In clean surgical

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procedures SSIs should occur in <2% of cases.[14] Higher rates of SSI are reported for specific incisions with SSIs occurring in 5.3% of cases of open inguinal hernia repair.[15] After WE for melanoma a SSI threshold of 2% was considered appropriate. Pathological margins after WE were not assessed. MIA surgeons follow the national guidelines for excision margins.[9]



Split and full thickness skin grafting are techniques for repairing tissue

defects. Complications rates are poorly documented in the literature. Graft failure

ACCEPTED MANUSCRIPT rates of 2-30% are reported and depend on the underlying pathology.[16] Failure of <20% of a graft is expected to be of limited clinical significance.[16] In this audit a graft was considered to have failed if >20% of the grafted area failed to



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take, and this was expected to be observed in <5% of cases.

After SNB minor surgical complications occur in approximately 10% and

lymphedema in <1% of patients.[17, 18] Seroma and wound infection rates have

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been reported at 5.5% and 4.6% respectively.[17] After SNB combined wound infection and seroma requiring aspiration rates of <5% were expected in our



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audit.

Morbidity and complications from RLND occur in up to 50% of patients

and rates vary depending on the site of the regional node field (neck, axilla,

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inguinal/ilio-inguinal). The parameters used to evaluate RLND in our audit are: number of retrieved lymph nodes, wound complications requiring intervention (infection, seroma, dehiscence, readmission and further surgery), vascular injury

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causing tissue loss and unintentional nerve injuries. Thresholds for complication rates are shown in Table 1. Recommendations for the number of nodes retrieved

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at RLND have been published on the basis of expert opinion [6] and a published series from MIA describing clinical experience with 2363 consecutive RLND procedures.[19] In the initial lymph node retrieval study the data for inguinal and ilio-inguinal dissection separately was not robust and a subsequent study described a series of 200 groin dissections (108 inguinal, 88 ilio-inguinal and 7 pelvic) to derive LN retrieval numbers for each operation.[20] In at least 90 percent of cases for the neck (≥ four levels), axilla, inguinal and ilio-inguinal regions the node counts should be ≥ 20, 10, 7 and 14 respectively (Table

ACCEPTED MANUSCRIPT 1).[19,20] The 90th percentile benchmark can be used in the audit process to represent the minimum acceptable node count.

Definitions for Audit

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WE and SNB were designated as minor procedures and RLNDs as major procedures. Neck dissections were described by anatomic levels and only dissections of ≥4 levels

were included in the LN retrieval figures. Axillary dissection at MIA is always a complete

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level 1-3 dissection with inclusion of part of the pectoralis minor muscle. Inguinal

dissection is a sub-inguinal groin dissection. Ilio-inguinal dissection includes a sub-

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inguinal groin dissection and dissection of at least some of the ipsilateral common iliac and all of the external iliac and obturator nodes in the pelvis.

Follow up

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Follow up for minor procedures was with the surgeon, general practitioner or MIA nursing clinic. Adverse events were reported back to the surgeon. Follow up after major

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RLND was with the surgeon.

Presentation of audit data:

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The six MIA surgeons presented their activity every three months at a “Parameters Meeting”. They reported: 1.

Demographics of practice

2.

KPIs –common complications and events that can occur after any

surgical procedure e.g. return to operating room 3.

MSSPIs – melanoma specific complications as discussed above

4.

Sentinel (or practice changing) events - designated as a category but none

were reported in the study period.

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A discussion of the details of any significant complications

Validating audit data To corroborate the self-reported audit data, RLND data were extracted from the

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independently collected MIA database for the same six MIA surgeons for 2011-12. A

total of 405 RLNDs were recorded and 362 dissections were included in the node count analysis. The analysis included the four main lymph node fields (axilla, neck ≥4 levels,

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inguinal and ilio-inguinal). Procedures excluded (n=43) were: conducted by two surgeons (n=3); other node fields (popliteal, pelvic only, triangular space, n=9); <4 levels in the

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neck (n=16); planned re-operative or partial procedures (n=15). Multiple lymph node fields they were assessed individually. The total lymph node retrieval number for each

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field was taken as the sum of nodes removed at SNB and RLND.

ACCEPTED MANUSCRIPT Results Self-reported audit data 2011-2012

1. Demographics of practice

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Total quarterly case numbers were reported. They were stratified into major and minor surgical procedures and whether these procedures were performed in public

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(community) or private hospitals (Table 2).

2. Key performance indicators (KPIs)

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KPIs collected were: death, pulmonary embolism (PE)/deep vein thrombosis (DVT), unplanned intensive care unit (ICU) admission, readmission to hospital and return to the operating room. In addition, any complaints lodged with the hospital, MIA or the

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Health Care Complaints Commission were audited (Table 3).

3. Melanoma surgery specific performance indicators (MSSPIs) MSSPI audit data are presented in Table 4. WE was rarely complicated when the wound

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was closed primarily or a flap repair was performed. SSG failure of >20% of the grafted area was observed in 5.9% of cases. In SNB procedures wound infection and seroma

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were uncommon, occurring in 1.8% of cases. After RLND 7.3% of patients had wound complications requiring intervention. RLND node counts fell below the previously established 90% standards in 1.2% of cases.

Corroborating self-reported audit data

To determine the accuracy of each surgeon’s self-reported data the RLND data were extracted from the MIA database for all six surgeons. The database contained details of

ACCEPTED MANUSCRIPT 405 RLNDs compared with 409 reported in the audit data. Of the 405 database RLNDs, 362 were defined RLNDs for one of the four specified fields (neck, axilla, inguinal, ilio-inguinal). Node counts were analysed for this subset (Table 5). MIA

while eight cases were identified in the database extraction.

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surgeons reported four cases where RLND node counts were below the 90% standard

In the data extracted from the MIA database, two neck dissection patients fell below the

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90% standard for node retrieval. In one patient 19 nodes were retrieved from the right neck after a previous bilateral occipital excision that had already included 15 nodes. In

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the second patient nine nodes were retrieved from a level II-V neck dissection and that patient had already had bilateral axillary dissections and was known to have other distant metastatic disease. Three inguinal dissection patients fell below the 90% standard. Two patients had coalescing large tumour masses with extensive extra-nodal spread. The third

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had six nodes identified. Three ilio-inguinal dissection patients fell below the 90% standard. Two had 13 nodes identified. One patient had 11 nodes identified but had had six nodes removed from the groin in a previous inguinal operation by a non-MIA

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surgeon.

ACCEPTED MANUSCRIPT Discussion Surgical audit is a systematic critical analysis of the quality of medical care in which standards are defined and data are collected and compared with these standards in order to improve the quality of patient care.[13] For the audit process to be successful

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standards must be carefully defined. This study demonstrates the process of setting

standards in our institution, reports the incidence of surgical complications compared to

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those standards.

Complications following WE are uncommon. Most occur in those patients requiring a

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SSG for wound coverage, with 5.9% of patients having loss of ≥20% of the grafted area. Complications following SNB, mainly seromas and wound infections, have been previously reported to occur in up to 10% of patients, [17, 18] but occurred in only 1.8% of patients in this series of 770 patients. The seromas reported in this audit were those

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that required intervention with aspiration. This definition may be in part responsible for the difference. Nevertheless, the low complication rate of SNB achieved at a large, dedicated melanoma treatment centre is important because those advocating against its

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use have cited much higher complication rates.[21]

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High quality surgery remains the most important treatment available to patients with stage III melanoma. Clinical trials continue to investigate the use of targeted inhibitors and immunotherapies in the adjuvant setting.[22] However, interferon, with significant side effects and a survival advantage of only 3%, remains the only approved systemic adjuvant therapy for melanoma patients who have undergone RLND for regional node metastases.[23]

ACCEPTED MANUSCRIPT After RLND 7.3% of patients experienced wound complications. Most were managed as outpatients with return to theatre and readmission to hospital occurring in <1%. With thorough surgery the number of nodes retrieved from a regional field falls within a predictable distribution.[19,20,24] Cases with low node counts should be critically

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assessed. Large coalescing tumour masses and previous surgery may reduce lymph node counts. The adequacy of surgery should be considered. When a standard surgical

procedure has been performed and node counts remain low then the specimen should be

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reassessed pathologically to see if further lymph nodes can be identified. One study has recently shown that at least 11, 14, 10 and 12 LNs were needed to accurately stage the

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axilla, neck, inguinal and ilio-inguinal LN fields.[25] Thus incomplete pathological assessment may not stage patients accurately even if the surgery is thorough.

The audited outcomes of MIA surgeons fall within the previously determined

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complication thresholds in almost all areas (Table 2). This good compliance could be a reflection of high quality surgery but more stringent thresholds might be appropriate. In particular, new higher thresholds for the 90% standard node retrieval parameters may be

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appropriate for axillary and neck dissections. In the axilla the 90% standard falls at 14 nodes in the current data (previously 10) while in the neck it falls at 27 nodes (previously

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20). It is interesting that after publishing data on RLND node retrieval numbers, the numbers of nodes in specimens has rarely fallen below the old 90% standard when by definition it should occur in 10% of cases. This means that either surgeons and/or pathologists are being more thorough, which can only lead to better staging and the possible benefits demonstrated by studies that link lower lymph node ratios with better prognosis.[24, 26, 27] The discrepancy between the number of self reported RLND cases and the number of cases retrieved from database analysis that fall below the 90% standard, four and eight respectively, is likely explained by surgeons not reporting low

ACCEPTED MANUSCRIPT node counts in cases where previous surgery removed lymph nodes from the same regional field (two cases) and where patients have been known to have large coalescing tumour masses making node counts unreliable (two cases). Very low rates of nerve palsies after RLND were reported and it is possible that temporary injuries were under-

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reported. This large audit included 4544 patients making chart review impractical and

consequently only the RLND node count data was corroborated by comparison to the

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MIA database.

Improved tumour control and overall survival are the most important outcomes in

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surgical oncology but cannot be assessed by regular audit because they require long-term follow up. Adherence to guidelines is part of routine practice for surgical oncologists and has been scrutinised in other recent publications.[11, 12] The parameters presented in this paper provide a platform that individual surgical oncologists can implement in their

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own audit cycles with the aim of improving patient outcomes. Large studies would be required to determine the impact of compliance with surgical quality assurance parameters such as these on patient outcomes in relation to tumour control, overall

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survival and quality of life.

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Conflict of interest statement

The author’s have no conflicts of interest.

Acknowledgments

This study was supported by Melanoma Institute Australia, the Friends of the Mater Hospital and the Melanoma Foundation of the University of Sydney. Rebecca Read is a Fellow at Melanoma Institute Australia.

ACCEPTED MANUSCRIPT References 1. Thompson JF, Scolyer RA, Uren RF. Surgical management of primary cutaneous melanoma: Excision margins and the role of sentinel lymph node examination. Surgical

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Oncology Clinics of North America 2006; 15(2):301-18.

2. Wong SL, Balch CM, Hurley P et al. Sentinel lymph node biopsy for melanoma: American Society of Clinical Oncology and Society of Surgical Oncology joint clinical

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practice guideline. Ann Surg Oncol 2012; 19:3313-24.

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3. Morton DL, Thompson JF, Cochran AJ, et al. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med 2014; 370(7): 599-609.

4. Morton D. Phase III randomized study of complete lymph node dissection versus

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observation in patients with localized cutaneous melanoma and sentinel node metastasis who have undergone sentinel lymphadenectomy. http://www.clinicaltrials.gov/ct2/show/NCT00389571?term_MSLT_II%

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2C_melanoma&rank_1 Vol. 2008: National Cancer Institute.

5. Caudle AS, Ross MI. Metastasectomy for stage IV melanoma: for whom and how much? Surg Oncol Clin N Am. 2011; 20:133-44.

6. Balch CM, Durant JR, Bartolucci AA. The impact of surgical quality control in multiinstitutional group trials involving adjuvant cancer treatments. Ann Surg. 1983;198:164–

ACCEPTED MANUSCRIPT 7. Heald RJ, Husband EM, Ryall D. The mesorectum in rectal cancer surgery: the clue to recurrence. Br J Surg 1982; 69: 613-16.

8. Sue-Ling HM, Johnston D, Martin IG et al. Gastric cancer: a curable disease in

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Britain. Br Med J 1993; 307:591-6.

9. Australian Cancer Network Melanoma Guidelines Revision Working party. Clinical

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Practice Guidelines for the Management of Melanoma in Australia and New Zealand. Cancer Council Australia and Australian Cancer Network, Sydney and New Zealand

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Guidelines Group, Wellington (2008).

10. NCCN. NCCN clinical practice guidelines in oncology. Melanoma v.2.2008. National Comprehensive Cancer Network (2008).

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11. Testori A, Soteldo J, Powell B et al. Surgical management of melanoma: an EORTC

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Melanoma Group survey. Ecancermedicalscience 2013; 28:294.

12. Bilimoria KY, Raval MV, Bentrem DJ, et al. National assessment of melanoma care

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using formally developed quality indicators. J Clin Oncol 2009; 27:5445-51.

13. Boult M, Maddern GJ. Clinical Audits: Why and for whom. ANZ J Surg 2007; 77: 572-578.

14. Leaper DJ. Risk factors for surgical infection. Journal of Hospital Infection. 1995; 30(Suppl):127–39.

ACCEPTED MANUSCRIPT 15. Taylor EW, Duffy K, Lee K et al. Surgical site infection after groin hernia repair. Br J Surg 2004; 91:105-11.

16. Henderson NJ, Fancourt M, Gilkison W, et al. Skin grafts: a rural general surgical

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perspective. ANZ J Surg 2009; 79:362-366.

17. Morton D, Cochran A, Thompson J, et al. Sentinel node biopsy for early-stage

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melanoma: accuracy and morbidity in MSLT-1, an international multicenter trial. Ann

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Surg 2005; 242:302–11.

18. Wrightson WR, Wong SL, Edwards MJ, et al. Complications associated with sentinel lymph node biopsy for melanoma. Ann Surg Oncol 2003;10:676–80.

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19. Spillane AJ, Cheung BL, Stretch JR, et al. Proposed quality standards for regional lymph node dissections in patients with melanoma. Ann Surg 2009; 249:473-80.

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20. Spillane A, Haydu L, McMillan W, et al. Quality assurance parameters and predictors of outcome for ilio-inguinal and inguinal dissection in a contemporary melanoma patient

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population. Ann Surg Oncol 2011; 18:2521-28.

21. Thomas, JM, Patocskai EJ. The argument against sentinel node biopsy for malignant melanoma. BMJ 2000; 321:3-4.

22. Espinosa E, Grob JJ, Dummer R, et al. Treatment Algorithms in Stage IV Melanoma. American journal of therapeutics 2014 [Epub]

ACCEPTED MANUSCRIPT 23. Mocellin S, Pasquali S, Rossi CR, Nitti D. Interferon alpha adjuvant therapy in patients with high-risk melanoma: a systematic review and meta-analysis. J Natl Cancer Inst 2010; 102:493-501.

survival in melanoma patients. Cancer 2009; 115:2505-13.

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24. Xing Y, Badgwell BD, Ross MI et al. Lymph node ratio predicts disease-specific

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25. Rossi CR, Mozzillo N, Maurichi A et al. The number of excised lymph nodes is associated with survival of melanoma patients with lymph node metastasis. Ann Oncol

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2014; 25:240-6.

26. Rossi CR, Mocellin S, Pasquali S et al. N-ratio: a novel independent prognostic

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factor for patients with stage-III cutaneous melanoma. Ann Surg Oncol 2008; 15(1):310.

27. Spillane AJ, Cheung BL, Winstanley J, Thompson JF. Lymph node ratio provides prognostic information in addition to AJCC N stage in patients with melanoma, even if

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the quality of surgery is standardized. Ann Surg 2011; 253:109-15.

ACCEPTED MANUSCRIPT Table 1: Melanoma specific surgical performance indicators

MSSPI

Detail

Proposed threshold <2%

WE-SG - loss > 20% area

<5%

WE-flap - necrosis

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WE-PC - dehiscence

<5%

SNB site infection or seroma

<5%

RLND wounds requiring intervention

Neck

RLND vascular injury causing tissue loss

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Unintentional nerve palsies

<10%

Groin/Pelvis

<30%

Neck

≥20

Axilla

≥10

Inguinal

≥7

Ilio-inguinal

≥14

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RLND minimum nodes removed in ≥90% cases

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Axilla

<5%

<1%

VII temporary

<50%

VII permanent

<20%

XI, LTN, TDN*

<2%

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*VII – 7th cranial (facial) nerve, XI – accessory nerve, LTN (long thoracic nerve) and TDN (thoracodorsal nerve).

ACCEPTED MANUSCRIPT Table 2: Practice demographics at MIA: quarterly surgical workload for 2011 and 2012 2011

Q2

Q3

Q4

Q1

Q2

Q3

Q4

676

520

516

542

584

551

568

586

Public

169

133

156

132

154

167

Private

281

206

268

255

281

247

Clinic

226

177

92

155

149

137

Unclassified

0

4

0

0

0

0

§

145

94

137

79

116

Minor

531

402

364

461

445

Unclassified

0

24

Major

15

2

23

568

190

167

159

249

251

255

129

162

153

0

6

1

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Operation

Mean/quarter

Q1 Total Hospital

2012

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Detail

103

103

67

106

434

448

478

445

41

17

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Melanoma operations

14

16

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Public = uninsured patients, managed in a public (community) hospital; Private = privately insured usually managed in a private hospital. Major = RLNDs, complex flaps, other major intra-abdominal or peripheral procedures. Minor = all other procedures. § Two surgeons counted an ilio-inguinal dissection as two major operations. If this is adjusted to a single operation then there are 36 less major operations over the two-year period and the average major surgeries per quarter is 102.

ACCEPTED MANUSCRIPT Table 3: General Key Performance Indicators (within 30 days of surgery in either public or private hospitals, patients with minor procedure performed in clinic excluded) for 2011 and 2012. KPI

2011

2012

Rate/1000

Q2

Q3

Q4

Q1

Q2

Q3

Q4

450

339

424

387

435

414

439

418

Death

0

0

0

0

0

0

PE/DVT

0

1

0

0

0

0

Unplanned ICU admission

1

0

0

0

0

1

Return to theatre

1

3

3

0

1

Readmission for complication

4

5

5

5

2

Complaints

0

0

0

0

0

-

0

0

1

0

0.6

0

0

0.6

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0

0

1

1

3.0

2

4

2

8.7

0

0

0

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Total patients

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Q1

0

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PE = pulmonary embolus; DVT = deep vein thrombosis; ICU = intensive care unit; Complaints = written or verbal complaint to MIA, hospitals or Health Care Complaints Commission or other government body. Q = quarter of year.

ACCEPTED MANUSCRIPT Table 4: MSSPIs for 2011 and 2012 from reported audit data* MSSPI

2011 §

2012

Total

%

3/302

11/2183

0.5

4/64

21/355

5.9

Q2

Q3

Q4

Q1

Q2

Q3

Q4

WE-PC dehiscence

2/321

0/365

3/188

1/267

1/264

1/245

0/231

WE-SG loss >20% area

8/36

2/45

3/39

1/39

2/52

1/40

0/40

WE-flap –necrosis

0/136

1/147

1/92

1/114

1/138

0/131

0/145

0/116

4/1019

0.4

SNB site infection/seroma

0/127

4/83

3/81

2/107

3/76

0/112

1/90

1/94

14/770

1.8

RLND wound requiring intervention

5/48

3/55

7/48

1/38

3/55

2/49

4/58

5/58

30/409

7.3

RLND node count below threshold

0/48

2/55

1/48

0/38

0/55

1/49

0/58

4/409

1.0

RLND vascular injury with tissue loss

0/48

0/55

0/48

Unintentional nerve palsy

1/48

1/55

0/48

SC

RI PT

Q1

M AN U

0/58

0/38

0/55

0/49

0/58

0/58

0/409

0

0/38

0/55

0/49

1/58

0/58

3/409

0.7

AC C

EP

TE D

*Ilio-inguinal dissection is counted as a single RLND for all surgeons. § Denominators for one surgeon not available but complications for that surgeon are included. Q = quarter of year.

ACCEPTED MANUSCRIPT Table 5: Regional lymph node dissections performed in 2011 and 2012 based on data extraction from the MIA database. Mean node count

Median node count

Range (number nodes)

Median nodes positive

Cases <90% standard

%Cases <90% standard

Axilla Surgeon 1 Surgeon 2 Surgeon 3 Surgeon 4 Surgeon 5 Surgeon 6 Total

12 28 6 15 16 75 152

23.8 28.4 36.7 22.9 20.8 24.8 25.4

22 25 36 19 17 23 23

15-35 10-50 11-74 10-53 12-36 14-55

1 1 1 1 1 1 1

0 0 0 0 0 0 0

0 0 0 0 0 0 0

Neck (≥4 levels) Surgeon 1 Surgeon 2 Surgeon 3 Surgeon 4 Surgeon 5 Surgeon 6 Total

0 9 59 13 0 5 86

45.4 47.3 40.6 36.2 45.4

36 47 37 39 41

1 1 2 1 1

0 1 1 0 2

0 1.7 7.7 0 2.3

Inguinal Surgeon 1 Surgeon 2 Surgeon 3 Surgeon 4 Surgeon 5 Surgeon 6 Total

3 20 1 0 0 31 55

10.0 11.5 16.0 12.9 12.3

1 2 2 1 1

0 1 0 2 3

0 5.0 0 6.5 5.5

Ilio-inguinal Surgeon 1 Surgeon 2 Surgeon 3 Surgeon 4 Surgeon 5 Surgeon 6 Total

0 14 2 33 0 20 69

1 2 2 3 2

1 0 0 2 3

7.1 0 0 10.0 4.2

SC

26-90 9-92 19-82 25-41

M AN U 10 10 13 11

TE D

AC C

EP

16.8 19.5 22.5 22.1 21.7

RI PT

Number cases

17 23 18 20

9-11 6-25 4-20

11-22 15-24 15-44 6-106