Association of Surgical Skill Assessment With Clinical Outcomes in Cancer Surgery

Nathan J Curtis, Jake D Foster, Danilo Miskovic, Chris S B Brown, Peter J Hewett, Sarah Abbott, George B Hanna, Andrew R L Stevenson, Nader K Francis, Nathan J Curtis, Jake D Foster, Danilo Miskovic, Chris S B Brown, Peter J Hewett, Sarah Abbott, George B Hanna, Andrew R L Stevenson, Nader K Francis

Abstract

Importance: Complex surgical interventions are inherently prone to variation yet they are not objectively measured. The reasons for outcome differences following cancer surgery are unclear.

Objective: To quantify surgical skill within advanced laparoscopic procedures and its association with histopathological and clinical outcomes.

Design, setting, and participants: This analysis of data and video from the Australasian Laparoscopic Cancer of Rectum (ALaCaRT) and 2-dimensional/3-dimensional (2D3D) multicenter randomized laparoscopic total mesorectal excision trials, which were conducted at 28 centers in Australia, the United Kingdom, and New Zealand, was performed from 2018 to 2019 and included 176 patients with clinical T1 to T3 rectal adenocarcinoma 15 cm or less from the anal verge. Case videos underwent blinded objective analysis using a bespoke performance assessment tool developed with a 62-international expert Delphi exercise and workshop, interview, and pilot phases.

Interventions: Laparoscopic total mesorectal excision undertaken with curative intent by 34 credentialed surgeons.

Main outcomes and measures: Histopathological (plane of mesorectal dissection, ALaCaRT composite end point success [mesorectal fascial plane, circumferential margin, ≥1 mm; distal margin, ≥1 mm]) and 30-day morbidity. End points were analyzed using surgeon quartiles defined by tool scores.

Results: The laparoscopic total mesorectal excision performance tool was produced and shown to be reliable and valid for the specialist level (intraclass correlation coefficient, 0.889; 95% CI, 0.832-0.926; P < .001). A substantial variation in tool scores was recorded (range, 25-48). Scores were associated with the number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications. Upper quartile-scoring surgeons obtained excellent results compared with the lower quartile (mesorectal fascial plane: 93% vs 59%; number needed to treat [NNT], 2.9, P = .002; ALaCaRT end point success, 83% vs 58%; NNT, 4; P = .03; 30-day morbidity, 23% vs 50%; NNT, 3.7; P = .03).

Conclusions and relevance: Intraoperative surgical skill can be objectively and reliably measured in complex cancer interventions. Substantial variation in technical performance among credentialed surgeons is seen and significantly associated with clinical and pathological outcomes.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Miskovic reported personal fees from Intuitive outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. The Laparoscopic Total Mesorectal Excision…
Figure 1.. The Laparoscopic Total Mesorectal Excision (TME) Performance Tool (LapTMEpt)
The accompanying manual is provided in the eAppendix in the Supplement. It consists of 4 vertical columns representing task areas and 4 horizontal rows representing the performance domains, creating 16 separate items that are scored on a scale of 1 to 4, in which a higher score indicates a more proficient technical performance and a total score of 64 indicates a perfect and proficient performance. Nv indicates neurovascular.
Figure 2.. Laparoscopic Total Mesorectal Excision (TME)…
Figure 2.. Laparoscopic Total Mesorectal Excision (TME) Performance Tool Score Analyses
A, Scattergraph displaying number of error events identified from observational clinical human reliability analysis (OCHRA) review with line of best fit and 95% CI. A moderate negative correlation is observed (rs = −0.515; P < .001) and is comparable with the previously reported laparoscopic colonic competency assessment tool concurrent validity. Each additional error event was associated with a 2-point drop in tool scores. B, Bar graph displaying the distribution of tool scores from the 176 cases. Substantial variation is observed despite both randomized clinical trials using surgeon-credentialing policies. C, Box-whisker plot comparing scores between the 3 case complexity grades. Lines represent the median and interquartile range with whiskers depicting the 95% CI. A significant decrease is observed with grade increase (43 [95% CI, 40-46] vs 39 [95% CI, 36-42] vs 36 [95% CI, 32-38]; P < .001).

References

    1. Markar SR, Wiggins T, Ni M, et al. . Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review. Lancet Oncol. 2015;16(1):e23-e31. doi:10.1016/S1470-2045(14)70419-X
    1. Vennix S, Pelzers L, Bouvy N, et al. . Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014;(4):CD005200. doi:10.1002/14651858.CD005200.pub3
    1. Monson JR, Probst CP, Wexner SD, et al. ; Consortium for Optimizing the Treatment of Rectal Cancer . Failure of evidence-based cancer care in the United States: the association between rectal cancer treatment, cancer center volume, and geography. Ann Surg. 2014;260(4):625-631. doi:10.1097/SLA.0000000000000928
    1. McCulloch P, Altman DG, Campbell WB, et al. ; Balliol Collaboration . No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105-1112. doi:10.1016/S0140-6736(09)61116-8
    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492
    1. Quirke P, Steele R, Monson J, et al. ; MRC CR07/NCIC-CTG CO16 Trial Investigators; NCRI Colorectal Cancer Study Group . Effect of the plane of surgery achieved on local recurrence in patients with operable rectal cancer: a prospective study using data from the MRC CR07 and NCIC-CTG CO16 randomised clinical trial. Lancet. 2009;373(9666):821-828. doi:10.1016/S0140-6736(09)60485-2
    1. Kitz J, Fokas E, Beissbarth T, et al. ; German Rectal Cancer Study Group . Association of plane of total mesorectal excision with prognosis of rectal cancer: secondary analysis of the CAO/ARO/AIO-04 phase 3 randomized clinical trial. JAMA Surg. 2018;153(8):e181607. doi:10.1001/jamasurg.2018.1607
    1. Leonard D, Penninckx F, Laenen A, Kartheuser A; PROCARE . Scoring the quality of total mesorectal excision for the prediction of cancer-specific outcome. Colorectal Dis. 2015;17(5):O115-O122. doi:10.1111/codi.12931
    1. Nagtegaal ID, van de Velde CJ, van der Worp E, Kapiteijn E, Quirke P, van Krieken JH; Cooperative Clinical Investigators of the Dutch Colorectal Cancer Group . Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002;20(7):1729-1734. doi:10.1200/JCO.2002.07.010
    1. Martínez-Pérez A, Carra MC, Brunetti F, de’Angelis N. Short-term clinical outcomes of laparoscopic vs open rectal excision for rectal cancer: a systematic review and meta-analysis. World J Gastroenterol. 2017;23(44):7906-7916. doi:10.3748/wjg.v23.i44.7906
    1. Acuna SA, Chesney TR, Ramjist JK, Shah PS, Kennedy ED, Baxter NN. Laparoscopic versus open resection for rectal cancer: a noninferiority meta-analysis of quality of surgical resection outcomes. Ann Surg. 2019;269(5):849-855.
    1. Stevenson AR, Solomon MJ, Lumley JW, et al. ; ALaCaRT Investigators . Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: the ALACART randomized clinical trial. JAMA. 2015;314(13):1356-1363. doi:10.1001/jama.2015.12009
    1. Fleshman J, Branda M, Sargent DJ, et al. . Effect of laparoscopic-assisted resection vs open resection of stage II or III rectal cancer on pathologic outcomes: the ACOSOG Z6051 randomized clinical trial. JAMA. 2015;314(13):1346-1355. doi:10.1001/jama.2015.10529
    1. Martínez-Pérez A, Carra MC, Brunetti F, de’Angelis N. Pathologic outcomes of laparoscopic vs open mesorectal excision for rectal cancer: a systematic review and meta-analysis. JAMA Surg. 2017;152(4):e165665. doi:10.1001/jamasurg.2016.5665
    1. Rickles AS, Dietz DW, Chang GJ, et al. ; Consortium for Optimizing the Treatment of Rectal Cancer (OSTRiCh) . High rate of positive circumferential resection margins following rectal cancer surgery: a call to action. Ann Surg. 2015;262(6):891-898. doi:10.1097/SLA.0000000000001391
    1. Birkmeyer JD, Finks JF, O’Reilly A, et al. ; Michigan Bariatric Surgery Collaborative . Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013;369(15):1434-1442. doi:10.1056/NEJMsa1300625
    1. Fecso AB, Szasz P, Kerezov G, Grantcharov TP. The effect of technical performance on patient outcomes in surgery: a systematic review. Ann Surg. 2017;265(3):492-501. doi:10.1097/SLA.0000000000001959
    1. Blencowe NS, Boddy AP, Harris A, et al. . Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials. Br J Surg. 2015;102(9):1037-1047. doi:10.1002/bjs.9808
    1. Miskovic D, Ni M, Wyles SM, et al. ; National Training Programme in Laparoscopic Colorectal Surgery in England . Is competency assessment at the specialist level achievable? a study for the national training programme in laparoscopic colorectal surgery in England. Ann Surg. 2013;257(3):476-482. doi:10.1097/SLA.0b013e318275b72a
    1. Miskovic D, Wyles SM, Carter F, Coleman MG, Hanna GB. Development, validation and implementation of a monitoring tool for training in laparoscopic colorectal surgery in the English National Training Program. Surg Endosc. 2011;25(4):1136-1142. doi:10.1007/s00464-010-1329-y
    1. Mackenzie H, Ni M, Miskovic D, et al. . Clinical validity of consultant technical skills assessment in the English National Training Programme for Laparoscopic Colorectal Surgery. Br J Surg. 2015;102(8):991-997. doi:10.1002/bjs.9828
    1. Curtis NJ, Davids J, Foster JD, Francis NK. Objective assessment of minimally invasive total mesorectal excision performance: a systematic review. Tech Coloproctol. 2017;21(4):259-268. doi:10.1007/s10151-017-1614-z
    1. Stevenson ARL, Solomon MJ, Brown CSB, et al. . Disease-free survival and local recurrence after laparoscopic-assisted resection or open resection for rectal Ccancer: the Australasian Laparoscopic Cancer of the Rectum randomized clinical trial. Ann Surg. 2019;269(4):596-602.
    1. Curtis NJ, Conti JA, Dalton R, et al. . 2D versus 3D laparoscopic total mesorectal excision: a developmental multicentre randomised controlled trial. Surg Endosc. 2019;33(10):3370-3383. doi:10.1007/s00464-018-06630-9
    1. Miskovic D, Foster J, Agha A, et al. . Standardization of laparoscopic total mesorectal excision for rectal cancer: a structured international expert consensus. Ann Surg. 2015;261(4):716-722. doi:10.1097/SLA.0000000000000823
    1. Britten N. Qualitative interviews in medical research. BMJ. 1995;311(6999):251-253. doi:10.1136/bmj.311.6999.251
    1. Foster JD, Miskovic D, Allison AS, et al. . Application of objective clinical human reliability analysis (OCHRA) in assessment of technical performance in laparoscopic rectal cancer surgery. Tech Coloproctol. 2016;20(6):361-367. doi:10.1007/s10151-016-1444-4
    1. Miskovic D, Ni M, Wyles SM, Parvaiz A, Hanna GB. Observational clinical human reliability analysis (OCHRA) for competency assessment in laparoscopic colorectal surgery at the specialist level. Surg Endosc. 2012;26(3):796-803. doi:10.1007/s00464-011-1955-z
    1. Foster JD, Ewings P, Falk S, et al. ; STARRCAT Investigators . Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial. Tech Coloproctol. 2016;20(10):683-693. doi:10.1007/s10151-016-1514-7
    1. Senders DM, Human Error NP. Cause, Prediction and Reduction. CRC Press; 1991.
    1. Foster JD, Mackenzie H, Nelson H, Hanna GB, Francis NK. Methods of quality assurance in multicenter trials in laparoscopic colorectal surgery: a systematic review. Ann Surg. 2014;260(2):220-229. doi:10.1097/SLA.0000000000000660
    1. Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015;351:h4672. doi:10.1136/bmj.h4672
    1. Gjeraa K, Spanager L, Konge L, Petersen RH, Østergaard D. Non-technical skills in minimally invasive surgery teams: a systematic review. Surg Endosc. 2016;30(12):5185-5199. doi:10.1007/s00464-016-4890-1

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