Quality and Outcome Assessment for Surgery.

ABSTRACT: This forum summarizes the proceedings of the joint European Surgical Association (ESA)/American Surgical Association (ASA) symposium on Quality and Outcome Assessment for Surgery that took place in Bordeaux, France, as part of the celebrations of the 30th anniversary of the ESA. Three presentations focused on a) the main messages from the Outcome4Medicine Consensus Conference, which took place in Zurich, Switzerland, in June 2022, b) the patient perspective, and c) benchmarking were hold by ESA members and discussed by ASA members in a symposium attended by members of both associations.

Toward a Consensus on Centralization in Surgery.

OBJECTIVES: To critically assess centralization policies for highly specialized surgeries in Europe and North America and propose recommendations. BACKGROUND/METHODS: Most countries are increasingly forced to maintain quality medicine at a reasonable cost. An all-inclusive perspective, including health care providers, payers, society as a whole and patients, has ubiquitously failed, arguably for different reasons in environments. This special article follows 3 aims: first, analyze health care policies for centralization in different countries, second, analyze how centralization strategies affect patient outcome and other aspects such as medical education and cost, and third, propose recommendations for centralization, which could apply across continents. RESULTS: Conflicting interests have led many countries to compromise for a health care system based on factors beyond best patient-oriented care. Centralization has been a common strategy, but modalities vary greatly among countries with no consensus on the minimal requirement for the number of procedures per center or per surgeon. Most national policies are either partially or not implemented. Data overwhelmingly indicate that concentration of complex care or procedures in specialized centers have positive impacts on quality of care and cost. Countries requiring lower threshold numbers for centralization, however, may cause inappropriate expansion of indications, as hospitals struggle to fulfill the criteria. Centralization requires adjustments in training and credentialing of general and specialized surgeons, and patient education. CONCLUSION/RECOMMENDATIONS: There is an obvious need in most areas for effective centralization. Unrestrained, purely "market driven" approaches are deleterious to patients and society. Centralization should not be based solely on minimal number of procedures, but rather on the multidisciplinary treatment of complex diseases including well-trained specialists available around the clock. Audited prospective database with monitoring of quality of care and cost are mandatory.

Comparison Costs of ERCP and MRCP in Patients with Suspected Biliary Obstruction Based on a Randomized Trial.

BACKGROUND: The optimal management of patients with suspected biliary obstruction remains unclear, and includes the possible performance of magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP). OBJECTIVES: To complete a cost analysis based on a medical effectiveness randomized trial comparing an ERCP-first approach with an MRCP-first approach in patients with suspected bile duct obstruction. METHODS: The management strategies were based on a medical effectiveness trial of 257 patients over a 12-month follow-up period. Direct and indirect costs were included, adopting a societal perspective. The cost values are expressed in 2012 Canadian dollars. RESULTS: Total per-patient direct costs were Can$3547 for ERCP-first patients and Can$4013 for MRCP-first patients. Corresponding indirect costs were Can$732 and Can$694, respectively. Causes for differences in direct costs included a more frequent second procedure and a greater mean number of hospital days over the year in patients of the MRCP-first group. In contrast, it is the ERCP-first patients whose indirect costs were greater, principally due to more time away from activities of daily living. Choosing an ERCP-first strategy rather than an MRCP-first strategy saved on average Can$428 per patient over the 12-month follow-up duration; however, there existed a large amount of overlap when varying total cost estimates across a sensitivity analysis range based on observed resources utilization. CONCLUSIONS: This cost analysis suggests only a small difference in total costs, favoring the ERCP-first group, and is principally attributable to procedures and hospitalizations with little impact from indirect cost measurements.

Hepato-pancreato-biliary surgery workforce in Canada.

This article characterizes the Canadian hepato-pancreato-biliary (HPB) surgery workforce (demographics, practice patterns, career satisfaction, education and recruitment plans). This information will serve as a baseline for future national comparisons, allow informed workforce planning and facilitate mathematical modelling of the HPB workforce in Canada.

Pancreatic cancer and predictors of survival: comparing the CA 19-9/bilirubin ratio with the McGill Brisbane Symptom Score.

INTRODUCTION: Few tools predict survival from pancreatic cancer (PAC). The McGill Brisbane Symptom Score (MBSS) based on symptoms at presentation (weight loss, pain, jaundice and smoking) was recently validated. The present study compares the ability of four strategies to predict 9-month survival: MBSS, carbohydrate antigen 19-9 (CA 19-9) alone, CA19-9-to-bilirubin ratio and a combination of MBSS and the CA19-9-to-bilirubin ratio. METHODOLOGY: A retrospective review of 133 patients diagnosed with PAC between 2005 and 2011 was performed. Survival was determined from the Quebec civil registry. Blood CA 19-9 and bilirubin values were collected (n = 52) at the time of diagnosis. Receiver-operating characteristic (ROC) curves were used to determine a cutoff for optimal test characteristics of CA 19-9 and CA19-9-to-total bilirubin ratio in predicting survival at 9 months. Predictive characteristics were then calculated for the four strategies. RESULTS: Of the four strategies, the one with the greatest negative predictive value was the MBSS: negative predictive value (NPV) was 90.2% (76.9-97.3%) and the positive likelihood ratio (LR) was the greatest. The ability of CA 19-9 levels alone, at baseline, to predict survival was low. For the CA19-9-to-bilirubin ratio, the test characteristics improved but remained non-significant. The best performing strategy according to likelihood ratios was the combined MBSS and CA19-9 to the bilirubin ratio. CONCLUSION: CA19-9 levels and the CA19-9-to-bilirubin ratio are poor predictors of survival for PAC, whereas the MBSS is a far better predictor, confirming its clinical value. By adding the CA19-9-to-bilirubin ratio to the MBSS the predictive characteristics improved.

Hepatitis C infection and hepatocellular carcinoma in liver transplantation: a 20-year experience.

BACKGROUND: Hepatitis C infection (HCV) and hepatocellular carcinoma (HCC), the two main causes of liver transplantation (LT), have reduced survival post-LT. The impact of HCV, HCC and their coexistence on post-LT survival were assessed. METHODOLOGY: All 601 LT patients from 1992 to 2011 were reviewed. Those deceased within 30 days (n = 69) and re-transplants (n = 49) were excluded. Recipients were divided into four groups: (a) HCC-/HCV-(n = 252) (b) HCC+/HCV- (n = 58), (c) HCC-/HCV+ (n = 106) and (d) HCC+/HCV+ (n = 67). Demographics, the donor risk index (DRI), Model for End-Stage Liver Disease (MELD) score, survival, complications and tumour characteristics were collected. Statistical analysis included anova, chi-square, Fisher's exact tests and Cox and Kaplan-Meier for overall survival. RESULTS: Groups were comparable with regards to baseline characteristics, but HCC patients were older. After adjusting for age, MELD, gender and the donor risk index (DRI), survival was lower in the HCC+/HCV+ group (59.5% at 5 yrs) and the hazard ratio (HR) was 1.90 [95% confidence interval (CI),1.24-2.95, P = 0.003] and 1.45 (95% CI, 0.99-2.12, P = 0.054) for HCC-/HCV+. HCC survival was similar to controls (HR 1.18, 95% CI, 0.71-1.93, P = 0.508). HCC+/HCV- patients exceeded the Milan criteria (50% versus 31%, P < 0.04) and had more micro-vascular invasion (37.5% versus 20.6%, P = 0.042). HCC+/HCV+ versus HCC+/HCV- survival remained lower (HR 1.94, 95% CI, 1.06-3.81, P = 0.041) after correcting for tumour characteristics and treatment. CONCLUSION: HCV patients had lower survival post-LT. HCC alone had no impact on survival. Patient survival decreased in the HCC+/HCV+ group and this appears to be as a consequence of HCV recurrence.

Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. Objective: To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. Design, Setting, and Participants: This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Interventions: Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main Outcomes and Measures: Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. Results: A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

A clinician's guide to patient selection for watchful waiting management of inguinal hernia.

OBJECTIVE: The goal of this study was to assist surgeons in managing patients with minimally symptomatic inguinal hernia by identifying characteristics that predict crossover to surgery or worsening of hernia symptoms. BACKGROUND: Randomized trials have suggested that watchful waiting management of minimally symptomatic inguinal hernia is an acceptable alternative to surgical repair. However, these trials found that roughly a quarter of patients would elect for repair in the first 2 years, suggesting that not all patients are good candidates for watchful waiting. METHODS: The 336 patients randomized to watchful waiting in the American College of Surgeons Watchful Waiting Hernia Trial constituted the study population. Preoperative patient characteristics were used to predict 2 outcomes, either crossover to surgery or the development of hernia pain limiting activities and/or crossover to surgery. Patients in our study were part of a previously registered randomized trial: NCT00263250. RESULTS: At 2 years, 72 patients crossed over to surgery, with pain with strenuous activities [odds ratio (OR), 1.3 per 10-mm visual analog scale pain scale], chronic constipation (OR, 4.9), prostatism (OR, 2.9), being married (OR, 2.3), and good health [OR, 3.0 American Society of Anesthesiologists Class (ASA) 1 vs 2], predicting crossover. An additional 28 patients developed pain, limiting their activities, with pain during strenuous activities (OR, 1.3 per 10-mm visual analog scale) and chronic constipation (OR, 4.5), predicting the combined outcome of pain limiting activities and/or crossover to surgery. Higher levels of activity reduced the risk (OR, 0.95) of this combined outcome. CONCLUSIONS: Readily identifiable patient characteristics can predict those patients with minimally symptomatic inguinal hernia who are likely to "fail" watchful waiting hernia management. Consideration of these factors will allow surgeons to optimally tailor hernia management.

Evaluation and stages of surgical innovations.

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

No surgical innovation without evaluation: the IDEAL recommendations.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

Challenges in evaluating surgical innovation.

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

Unresectable pancreatic adenocarcinoma: do we know who survives?

BACKGROUND: This study attempts to define clinical predictors of survival in patients with unresectable pancreatic adenocarcinoma (UPA). METHODS: A retrospective study of 94 consecutive patients diagnosed with UPA from 2001 to 2006 was performed. Using data for these patients, a symptom score was devised through a forward stepwise Cox proportional hazards model based on four weighted criteria: weight loss of >10% of body weight; pain; jaundice, and smoking. The symptom score was subsequently validated in a distinct cohort of 32 patients diagnosed with UPA in 2007. RESULTS: In the original cohort, the overall median survival was 9.0 months (95% confidence interval [CI] 7.6-10.4). This altered to 10.3 months (95% CI 6.1-14.5) in patients with locally advanced disease, and 6.6 months (95% CI 4.2-9.0) in patients with distant metastasis. Median survival was 14.6 months (95% CI 13.1-16.1) in patients with a low symptom (LS) score and 6.3 months (95% CI 4.1-8.5) in patients with a high symptom (HS) score. A total of 73% of LS score patients survived beyond 9 months, compared with only 38% of HS score patients (P<0.001). The discrimination of the LS score was greater than that of any conventional method, including imaging. The validation cohort confirmed the discriminative ability of the symptom score for survival. CONCLUSIONS: A simple and clinically meaningful point-based symptom score can successfully predict survival in patients with UPA.

Preoperative alpha-fetoprotein slope is predictive of hepatocellular carcinoma recurrence after liver transplantation.

BACKGROUND: Liver transplantation (LT) offers a possible cure for patients with hepatocellular carcinoma (HCC) and cirrhosis. However, tumour progression while on the waiting list and tumour recurrence after LT are common. The prognostic significance of various pre- and postoperative variables were investigated in regard to tumour recurrence, with an emphasis on the slope of preoperative serum alpha-fetoprotein (AFP) levels. patients and METHODS: Data from 48 patients who had HCC diagnosed preoperatively and underwent LT at the McGill University Health Centre (Montreal, Quebec) were reviewed retrospectively, and possible risk factors for tumour recurrence were examined. RESULTS: Univariate analysis revealed a positive correlation between the preoperative AFP slope and vascular invasion (P = 0.045), total tumour diameter at explant (P = 0.040), Cancer of the Liver Italian Program score (P = 0.017) and recurrence-free survival (P = 0.028). Of the preoperative variables examined, only the preoperative AFP slope was identified as an independent predictor of tumour recurrence by multivariate analysis. Receiver operating characteristic analysis showed that the best discriminant cut-off value, calculated as the value of the maximized likelihood ratio, was preoperative AFP slope greater than 50 microg/L per month. At this cut-off, sensitivity was 36%, and specificity was 97%. Patients with a preoperative AFP slope greater than 50 microg/L per month had a much worse one-year recurrence-free survival rate than those with a preoperative AFP slope 50 microg/L per month or less (40% versus 90%, P < 0.001). CONCLUSIONS: These results suggest that the preoperative AFP slope is an important predictor of HCC recurrence after LT and should be examined in future studies of patients receiving LT for HCC.

Evaluating surgical outcomes.

The study of outcomes has become essential for guiding quality of-care assessment and for clinical research. In this article, the properties and process of patient outcomes measurement are described. The limitations of traditional outcomes are discussed and contrasted with the emerging concept of "patient-centered"outcomes, measured by validated instruments to assess the effects of surgical interventions on health-related quality of life, functional status, pain, and patient satisfaction. The strengths and weaknesses of several measurement tools used in the surgical literature are evaluated. Finally, the authors introduce "composite outcomes" as a reflection of the multidimensional nature of modern patient care.

Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.

CONTEXT: Many men with inguinal hernia have minimal symptoms. Whether deferring surgical repair is a safe and acceptable option has not been assessed. OBJECTIVE: To compare pain and the physical component score (PCS) of the Short Form-36 Version 2 survey at 2 years in men with minimally symptomatic inguinal hernias treated with watchful waiting or surgical repair. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial conducted January 1, 1999, through December 31, 2004, at 5 North American centers and enrolling 720 men (364 watchful waiting, 356 surgical repair) followed up for 2 to 4.5 years. INTERVENTIONS: Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tension-free repair and were followed up at 3 and 6 months and annually. MAIN OUTCOME MEASURES: Pain and discomfort interfering with usual activities at 2 years and change in PCS from baseline to 2 years. Secondary outcomes were complications, patient-reported pain, functional status, activity levels, and satisfaction with care. RESULTS: Primary intention-to-treat outcomes were similar at 2 years for watchful waiting vs surgical repair: pain limiting activities (5.1% vs 2.2%, respectively; P = .06 [corrected]); PCS (improvement over baseline, 0.29 points vs 0.13 points; P = .79). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17% assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over improved after repair. Occurrence of postoperative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. One watchful-waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years; a second had acute incarceration with bowel obstruction at 4 years, with a frequency of 1.8/1000 patient-years inclusive of patients followed up for as long as 4.5 years. CONCLUSIONS: Watchful waiting is an acceptable option for men with minimally symptomatic inguinal hernias. Delaying surgical repair until symptoms increase is safe because acute hernia incarcerations occur rarely.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00263250.

Stenting in Malignant Biliary Obstruction.

Decompression of the biliary system in patients with malignant biliary obstruction has been widely accepted and implemented as part of the care. Despite a wealth of literature, there remains a significant amount of uncertainty as to which approach would be most appropriate in different clinical settings. This review covers stenting of the biliary system in cases of resectable or palliative malignant biliary obstruction, potential candidates for biliary drainage, technical aspects of the procedure, as well as management of biliary stent dysfunction. Furthermore, periprocedural considerations including proper mapping of the location of obstruction and the use of antibiotics are addressed.

Expert Intraoperative Judgment and Decision-Making: Defining the Cognitive Competencies for Safe Laparoscopic Cholecystectomy.

BACKGROUND: Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. This qualitative study aimed to define and characterize higher-order cognitive competencies required to safely perform a laparoscopic cholecystectomy. STUDY DESIGN: Hierarchical and cognitive task analyses for establishing a critical view of safety during laparoscopic cholecystectomy were performed using qualitative methods to map the thoughts and practices that characterize expert performance. Experts with more than 5 years of experience, and who have performed at least 100 laparoscopic cholecystectomies, participated in semi-structured interviews and field observations. Verbal data were transcribed verbatim, supplemented with content from published literature, coded, thematically analyzed using grounded-theory by 2 independent reviewers, and synthesized into a list of items. RESULTS: A conceptual framework was created based on 10 interviews with experts, 9 procedures, and 18 literary sources. Experts included 6 minimally invasive surgeons, 2 hepato-pancreatico-biliary surgeons, and 2 acute care general surgeons (median years in practice, 11 [range 8 to 14]). One hundred eight cognitive elements (35 [32%] related to situation awareness, 47 [44%] involving decision-making, and 26 [24%] action-oriented subtasks) and 75 potential errors were identified and categorized into 6 general themes and 14 procedural tasks. Of the 75 potential errors, root causes were mapped to errors in situation awareness (24 [32%]), decision-making (49 [65%]), or either one (61 [81%]). CONCLUSIONS: This study defines the competencies that are essential to establishing a critical view of safety and avoiding bile duct injuries during laparoscopic cholecystectomy. This framework may serve as the basis for instructional design, assessment tools, and quality-control metrics to prevent injuries and promote a culture of patient safety.