Multicentre positive deviance seminar to generate best practice recommendations to reduce anastomotic leak and length of stay for patients undergoing oesophagectomy.

BACKGROUND: We describe a novel process using positive deviance (PD) with the Canadian Association of Thoracic Surgeons members, to identify perioperative best practice to minimise anastomotic leak (AL) and length of stay (LOS) following oesophagectomy. To our knowledge, this is the first National combination of level 1 evidence with expert opinion (ie, PD seminar) aimed at reducing AL and LOS in oesophageal surgery. Our primary hypothesis is that a multicentre National PD seminar is feasible, and could lead to the generation of best practices recommendations aimed at reducing AL and LOS in patients with oesophageal cancer. METHODS: Adverse events, LOS and AL incidence/severity following oesophagectomy were prospectively collected from seven Canadian thoracic institutions using Thoracic Morbidity and Mortality classification system (2017-2020). Anonymised display of centre's data were presented, with identification of centres demonstrating PD. Surgeons from PD sites discussed principles of care, culminating in the consensus recommendations, anonymously rated by all (5-point Likert scale). RESULTS: Data from 795 esophagectomies were included, with 25 surgeons participating. Two centres were identified as having the lowest AL rates 44/395 (11.1%) (vs five centres 71/400 (17.8%) (p<0.01)) and shortest LOS 8 days 45 (IQR: 6-14) (vs 10 days (IQR: 8-18) (p<0.001)). Recommendations included preoperative (prehabilitation, smoking cessation, chemotherapy for patients with dysphagia, minimise stents/feeding tubes), intraoperative (narrow gastric conduit, intrathoracic anastomosis, avoid routine jejunostomy, use small diameter closed-suction drains), postoperative day (POD) (early (POD 2-3) enteral feeding initiation, avoid routine barium swallow studies, early removal of tubes/drains (POD 2-3)). All ranked above 80% (4/5) in agreement to implement recommendations into their practice. CONCLUSION: We report the feasibility of a National multicentre PD seminar with the generation of best practice recommendations aimed at reducing AL and LOS following oesophagectomy. Further research is required to demonstrate whether National PD seminars can be an effective quality improvement tool.

Index hospital cost of adverse events following thoracic surgery: a systematic review of economic literature.

OBJECTIVES: Adverse events (AEs) following thoracic surgery place considerable strain on healthcare systems. A rigorous evaluation of the economic impact of thoracic surgical AEs remains lacking and is required to understand the value of money of formal quality improvement initiatives. Our objective was to conduct a systematic review of all available literature focused on specific cost of postoperative AEs following thoracic surgery. DESIGN: Systematic review of the economic literature was performed, following recommendations from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA SOURCES: An economic search filter developed by the Canadian Agency for Drugs and Technologies in Health was applied, and MEDLINE, Embase and The Cochrane Library were searched from inception to January 2022. ELIGIBILITY CRITERIA: We included English articles involving adult patients who underwent a thoracic surgical procedure with estimated costs of postoperative complications. Eligible study designs included comparative observational studies, randomised control trials, decision analytic or cost-prediction models, cost analyses, cost or burden of illness studies, economic evaluation studies and systematic reviews and/or meta-analyses of cost analyses and cost of illness studies. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently screened titles and abstracts in the first stage and full-text articles of included studies in the second stage. Disagreements during abstract and full-text screening stages were resolved via discussion until a consensus was reached. Studies were appraised for methodological quality using the Critical Appraisal Skills Program checklist. RESULTS: 3349 studies were identified: 20 met inclusion criteria. Most were conducted in the USA (12/20), evaluating AE impact on hospital expenditures (18/20). 68 procedure-specific AE mean costs were characterised (USD$). The most commonly described were anastomotic leak (mean:range) (USD$49 278:$6 176-$133 002) and pneumonia ($12 258:$2608-$34 591) following esophagectomy, and prolonged air leak ($2556:$571-$3573), respiratory failure ($19 062:$11 841-$37 812), empyema ($30 189:$23 784-$36 595), pneumonia ($15 362:$2542-$28 183), recurrent laryngeal nerve injury ($16 420:$4224-$28 616) and arrhythmia ($6835:$5833-$8659) following lobectomy. CONCLUSIONS: Hospital costs associated with AEs following thoracic surgery are substantial and varied. Quantifying costs of AEs enable future economic evaluation studies, which could help prioritising value-directed quality improvement to optimally improve outcomes and reduce costs.

Multicentre positive deviance to reduce adverse events and length of stay after pulmonary resection.

BACKGROUND: Postoperative adverse events (AEs) following pulmonary resection enormously impact patient well-being, length of stay (LOS) and healthcare costs. Standardised AE data collection can be used to identify positive outliers demonstrating positive deviance (PD) who may be helpful to inform the best practice. Here, we describe our initial experience of a novel quality improvement process using PD to reduce LOS and AEs. METHODS: AE rates and LOS were collected from four centres (2014-2020) using a common dictionary. Surgeons repeatedly participated in 60 to 90 min seminars consisting of the following process: identify outcome and procedure targeted, review relevant best evidence literature, view all data anonymised by surgeon or centre (if multicentre), choose and reveal identity of best performance PD outliers, who discuss their management principles while all receive self-evaluation reports, followed by collegial discussion to generate consensus recommendations, voted by all. We assessed overall impact on AEs and LOS using aggregate data in a before/after analysis. RESULTS: A total of 131 surgeons (average 12/seminar) participated in 11 PD seminars (8 local and 3 multicentre), yielding 85 consensus recommendation (average 8/seminar). Median LOS following lobectomy decreased from 4.0 to 3.0 days (p=0.04) following local PD seminars and from 4.0 to 3.5 days (p=0.11) following multicentre seminars. Trends for reductions in multiple AE rates were also observed. CONCLUSION: While limited by the longitudinal design, these findings provide preliminary support for this data-driven, collegial and actionable quality improvement process to help standardise and improve patient care, and merits further more rigorous investigation.

Are sequential compression devices routinely necessary following enhanced recovery after thoracic surgery?

OBJECTIVES: The prominence of "enhanced recovery after surgery" (ERAS) protocols being adopted in thoracic surgery requires a re-evaluation of mechanical venous thromboembolism (VTE) prophylaxis guidelines. The goal of this study was to assess the role of sequential compression devices (SCD) in the prevention of VTEs such as deep vein thrombosis and pulmonary embolism (PE) in thoracic surgical patients. METHODS: We identified 200 patients who underwent elective oncological thoracic surgery between December 2018 and December 2020 in 2 cohorts-1 with SCDs and 1 without (i.e. non-SCD). All patients followed a standardized enhanced recovery after surgery (ERAS) protocol. The quality of care provided by SCDs was evaluated by the incidence and severity of postoperative and follow-up VTEs. Cohorts were compared by the Caprini score (CS) and the Charlson Comorbidity Index (CCI) with a two one-sided t-test analysis. Secondary outcomes include perioperative characteristics and follow-up data. RESULTS: Only 2 patients within the SCD group developed a PE with average CS and CCI metrics, both after hospital discharge and treated with anticoagulants, raising concern over the prophylactic nature of SCDs. The CS (6.9 ± 1.3 and 6.9 ± 1.5; P = 0.96) and the CCI (3.8 ± 2.0 and 4.1 ± 2.6; P = 0.33) for non-SCD and SCD, respectively, did not differ. The two one-sided t-test analysis for CS (P < 0.001) and CCI (P < 0.001) demonstrated equivalence. CONCLUSIONS: Although larger studies are required to confirm these results, routine SCD use may not be required when implementing ERAS protocols because clinically significant VTE rates were minimal.

Evolution of Process and Outcome Measures during an Enhanced Recovery after Thoracic Surgery Program.

BACKGROUND: A time course analysis was undertaken to evaluate how perioperative process-of-care and outcome measures evolved after implementation of an enhanced recovery after thoracic surgery (ERATS) program. METHODS: Outcome and process-of-care measures were compared between patients undergoing major elective thoracic surgery during a 9-month pre-ERATS implementation period to those at 1-3, 4-6, and 7-9 months post-ERATS implementation. Outcome measures included length of stay, the 30-day readmission rate, 30-day emergency department visits, and minor and major adverse events. Process measures included first time to activity, out-of-bed, ambulation, fluid diet, diet as tolerated, as well as removal of the first and last chest tube, epidural, patient-controlled analgesia, and Foley and intravenous catheters. RESULTS: In total, 704 patients (352 pre-ERATS, 352 post-ERATS) were included. Mobilization-related process measures, including time to first activity (16.5 vs. 6.8 hours, p<0.001), out-of-bed (17.6 vs. 8.9 hours, p<0.001), and ambulation (32.4 vs. 25.4 hours, p=0.04) saw statistically significant improvements by 1-3 months post-ERATS implementation compared to pre-ERATS. Time to Foley removal improved by 4-6 months post-ERATS (19.5 vs. 18.2 hours, p=0.003). Outcome measures, including the 30-day readmission rate and emergency department visits, steadily decreased post-ERATS. By 7-9 months post-ERATS, both minor (18.2% vs. 7.9%, p=0.009) and major (13.6% vs. 4.4%, p=0.007) adverse events demonstrated statistically significant improvements. Length of stay trended towards improvement from 6.2 days pre-ERATS to 4.8 days by 7-9 months post-ERATS (p=0.06). CONCLUSION: The adoption of ERATS led to improvements in multiple process-of-care measures, which may collectively and gradually achieve optimization of clinical outcomes.

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care.

There is great potential for standardized postoperative adverse events data collection to document, inform, audit, and feedback, all to optimize patient care. Adverse events, defined as any deviation from expected recovery from surgery, have harmful implications for patients, their families, and clinicians. Postoperative adverse events occur frequently in thoracic surgery, predominately due to the high-stakes (ie, high potential for cure) and high-risk (ie, vital physiology and anatomy and preexisting disease) nature of the surgery. As discussed, engaging surgeons in audit and feedback practices informed by standardized data collection would generate consensus recommendations to reduce adverse events and improve patient outcomes.

Feasibility of implementing Extubation Advisor, a clinical decision support tool to improve extubation decision-making in the ICU: a mixed-methods observational study.

OBJECTIVES: Although spontaneous breathing trials (SBTs) are standard of care to extubation readiness, no tool exists that optimises prediction and standardises assessment. In this study, we evaluated the feasibility and clinical impressions of Extubation Advisor (EA), a comprehensive clinical extubation decision support (CDS) tool. DESIGN: Phase I mixed-methods observational study. SETTING: Two Canadian intensive care units (ICUs). PARTICIPANTS: We included patients on mechanical ventilation for ≥24 hours and clinicians (respiratory therapists and intensivists) responsible for extubation decisions. INTERVENTIONS: Components included a predictive model assessment, feasibility evaluation, questionnaires and interviews with clinicians. RESULTS: We enrolled 117 patients, totalling 151 SBTs and 80 extubations. The incidence of extubation failure was 11% in low-risk patients and 21% in high-risk patients stratified by the predictive model; 38% failed extubation when both the model and clinical impression were at high risk. The tool was well rated: 94% and 75% rated the data entry and EA report as average or better, respectively. Interviews (n=15) revealed favourable impressions regarding its user interface and functionality, but unexpectedly, also concerns regarding EA's potential impact on respiratory therapists' job security. CONCLUSIONS: EA implementation was feasible, and users perceived it to have potential to support extubation decision-making. This study helps to understand bedside implementation of CDS tools in a multidisciplinary ICU. TRIAL REGISTRATION NUMBER: NCT02988167.

Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial.

BACKGROUND: Despite curative intent resection in patients with non-small cell lung cancer (NSCLC), recurrence leading to mortality remains too common. Melatonin has shown promise for the treatment of patients with lung cancer; however, its effect following cancer resection has not been studied. We evaluated if melatonin taken after complete resection reduces lung cancer recurrence and mortality, or impacts quality of life (QOL), symptomatology or immune function. METHODS: Participants received melatonin (20 mg) or placebo nightly for one year following surgical resection of primary NSCLC. The primary outcome was two-year disease-free survival (DFS). Secondary outcomes included five-year DFS, adverse events, QOL, fatigue, sleep, depression, anxiety, pain, and biomarkers assessing for immune function/inflammation. This study is registered at https://clinicaltrials.gov NCT00668707. FINDINGS: 709 patients across eight centres were randomized to melatonin (n = 356) versus placebo (n = 353). At two years, melatonin showed a relative risk of 1·01 (95% CI 0·83-1·22), p = 0·94 for DFS. At five years, melatonin showed a hazard ratio of 0·97 (95% CI 0·86-1·09), p = 0·84 for DFS. When stratified by cancer stage (I/II and III/IV), a hazard reduction of 25% (HR 0·75, 95% CI 0·61-0·92, p = 0·005) in five-year DFS was seen for participants in the treatment arm with advanced cancer (stage III/IV). No meaningful differences were seen in any other outcomes. INTERPRETATION: Adjuvant melatonin following resection of NSCLC does not affect DFS for patients with resected early stage NSCLC, yet may increase DFS in patients with late stage disease. Further study is needed to confirm this positive result. No beneficial effects were seen in QOL, symptoms, or immune function. FUNDING: This study was funded by the Lotte and John Hecht Memorial Foundation and the Gateway for Cancer Research Foundation.

Harmonization of adverse events monitoring following thoracic surgery: Pursuit of a common language and methodology.

Objective: Thoracic surgery carries significant risk of postoperative adverse events (AEs). Multiple international recording systems are used to define and collect AEs following thoracic surgery procedures. We hypothesized that a simple-yet-ubiquitous approach to AE documentation could be developed to allow universal data entry into separate international databases. Methods: AE definitions of the Canadian Association of Thoracic Surgeons (CATS) system and 4 international databases were matched and compared. This consisted of reviewing the definition of each AE as described by their respective database and assessing compatibility with the CATS system. We developed a single set of 4 drop-down menus to enable clear classification and facilitated data entry, using 3 single-select mandatory lists and 1 multiselect optional list classifying type and severity of these events. Results: The CATS data elements were harmonized (ie, perfect or good) with 100% (European Society of Thoracic Surgeons), 89% (Society of Thoracic Surgeons), 74% (Esophagectomy Complications Consensus Group), and 73% (National Surgical Quality Improvement Program) of respective data elements. The addition of 17 AEs and 2 complication modifiers to the CATS system was implemented to achieve complete harmonization. Consequently, 100% of AE data elements currently included in all 4 international databases are perfectly or well-harmonized with the revised 4-choice drop down menu. Conclusions: We describe a framework for a ubiquitously applicable approach to AE monitoring following thoracic surgery harmonized with AE definitions of all major thoracic international associations. Use of this AE collection framework allows for comprehensive evaluation of both the incidence and severity of all AEs after thoracic surgery along with quality indicators.

Correction to: Postoperative Adverse Events are Associated with Oncologic Recurrence Following Curative­intent Resection for Lung Cancer.

The original version of this article unfortunately contained a mistake in author names. The given and family names of all the authors was transposed. The author names are corrected with this correction. The original article has been corrected.

Postoperative Adverse Events are Associated with Oncologic Recurrence Following Curative-intent Resection for Lung Cancer.

BACKGROUND: Up to 50% of patients suffer short-term postoperative adverse events (AEs) and metastatic recurrence in the long-term following curative-intent lung cancer resection. The association between AEs, particularly infectious in nature, and disease recurrence is controversial. We sought to evaluate the association of postoperative AEs on risk of developing recurrence and recurrence-free survival (RFS) following curative-intent lung resection surgery. METHODS: All lung cancer resections at a single institution (January 2008-July 2015) were included, with prospective collection of AEs using the Thoracic Morbidity & Mortality System. Cox proportional hazards models were used to estimate the effect of AEs on recurrence, with results presented as hazard ratio (HR) with 95% confidence interval (CI). An a priori, clinically driven approach to predictor variable selection was used. Kaplan-Meier curves were used examine the relationship between AE and RFS. p < 0.05 was considered statistically significant. RESULTS: 892 patients underwent curative-intent resection. 342 (38.3%) patients experienced an AE; 69 (7.7%) patients developed infectious AEs. 17.6% (n = 157) of patients had disease recurrence after mean follow-up of 26.5 months. Severe (Grade IV) AEs were associated with increased risk of recurrence (3.40; 95% CI 1.56-7.41) and a trend to decreased RFS. Major infectious AEs were associated with increased risk of recurrence (HR 1.71; CI 1.05-2.8) and earlier time to recurrence (no infectious AE 66 months, minor infectious 41 months, major infectious 54 months; p = 0.02). CONCLUSION: For patients undergoing curative-intent lung cancer resection, postoperative AEs associated with critical illness or major infection were associated with increased risk of oncologic recurrence.

Impact of Surgeon Self-evaluation and Positive Deviance on Postoperative Adverse Events After Non-cardiac Thoracic Surgery.

As an innovative approach to improve quality of surgical care, we combined surgeon self-assessment and anonymized peer comparison with continuous quality improvement seminars using positive deviance (CQI/PD) to identify surgeon(s) with the lowest rates of adverse events (AEs) to guide group practice recommendations. Our objective was to quantify the impact these interventions on postoperative AEs rates after major non-cardiac chest operations. All postoperative AEs after all thoracic operations (n = 1,084, March, 2013 to February, 2016, single-center) were prospectively collected using the thoracic morbidity and mortality system, based on Clavien-Dindo schema. Online software provided surgeons (n = 6) with self-evaluation and peer comparison at all times. In addition, quarterly CQI/PD seminars (n = 8, September, 2013 to December, 2015) focused on common impactful AEs: atrial fibrillation (AFIB), prolonged alveolar air leak (PAAL), and anastomotic leak (AL). Impact was analyzed using univariate statistics 6, 9, and 12 months before and after implementation. We observed reductions of postoperative AEs after CQI/PD: a decrease (all time periods) in AFIB, greatest at 6 months (10.1% vs. 6.7%; p = .36); a decrease (all time periods) in PAAL, greatest at 12 months (18.9% vs. 11.7%; p < .05); and decrease (6 and 9 months) in AL, greatest at 6 months (11.1% vs. 8.3%; p = .82). Improvements in AE rates after individual surgeon self-evaluation and CQI/PD seminars provide encouraging results that merit further investigation.

Impact of Adverse Events and Length of Stay on Patient Experience After Lung Cancer Resection.

BACKGROUND: Postoperative adverse events (AEs), prolonged length of stay (PLOS), and patient experience are common quality measures after thoracic surgical procedures. Our objective was to investigate the relationship of postoperative AEs on patient experience and hospital length of stay (LOS) after lung cancer resection. METHODS: AEs (using Thoracic Morbidity and Mortality system based on Clavien-Dindo schema) and LOS were prospectively collected for all patients undergoing lung cancer resection. A 21-item questionnaire, retrospectively asking about patient experience, was mailed to patients twice (October 2015 and January 2016). The impact of AEs on experience was investigated and stratified by hospital LOS, with PLOS defined as the 75th percentile. Univariate analysis used parametric (t test) and nonparametric (Mann-Whitney) tests according to test conditions. RESULTS: Of 288 patients who responded to the survey (70% response rate), 175 (61%) had no AEs, 113 (39%) had experienced at least one AE, and 52 (18%) had experienced PLOS. Lung cancer patients who experienced PLOS showed significantly decreased experience on several questionnaire items, including their impression of comprehensiveness of surgeons information provision during inpatient period (p = 0.008), inpatient recovery from operation (p = 0.001), quality of life 30 days after operation (p = 0.032), follow-up care, (p = 0.022), and satisfaction with outcome 1 year after operation during follow-up care (p = 0.022). The presence of postoperative AEs led only to reduced impression about inpatient recovery from the operation (p = 0.01). CONCLUSIONS: In this cohort, postoperative AEs were minimally associated with negative patient experience. However, patients who experienced PLOS demonstrated a marked reduction in experience after thoracic surgical procedures.

Using Surgeon-Specific Outcome Reports and Positive Deviance for Continuous Quality Improvement.

BACKGROUND: Using the thoracic morbidity and mortality classification to document all postoperative adverse events between October 2012 and February 2014, we created surgeon-specific outcome reports (SSORs) to promote self-assessment and to implement a divisional continuous quality improvement (CQI) program, on the construct of positive deviance, to improve individual surgeon's clinical performance. METHODS: Mixed-methods study within a division of six thoracic surgeons, involving (1) development of real-time, Web-based, risk-adjusted SSORs; (2) implementation of CQI seminars (n = 6; September 2013 to June 2014) for evaluation of results, collegial discussion on quality improvement based on identification of positive outliers, and selection of quality indicators for future discussion; and (3) in-person interviews to identify facilitators and barriers to using SSORs and CQI. Interview transcripts were analyzed using thematic analysis. RESULTS: Interviews revealed enthusiastic support for SSORs as a means to improve patient care through awareness of personal outcomes with blinded divisional comparison for similar operations and diseases, and apply the learning objectives to continuous professional development and maintenance of certification. Perceived limitations of SSORs included difficulty measuring surgeon expertise, limited understanding of risk adjustment, resistance to change, and belief that knowledge of sensitive data could lead to punitive actions. All surgeons believed CQI seminars led to collegial discussions, whereas perceived limitations included quorum participation and failing to circle back on actionable items. CONCLUSIONS: Real-time performance feedback using SSORs can motivate surgeons to improve their practice, and CQI seminars offer the opportunity to review and interpret results and address issues in a supportive environment. Whether SSORs and CQI can lead to improvements in rates of postoperative adverse events is a matter of ongoing research.

Measuring surgical quality: comparison of postoperative adverse events with the american college of surgeons NSQIP and the Thoracic Morbidity and Mortality classification system.

BACKGROUND: Monitoring surgical outcomes is critical to quality improvement; however, different data-collection methodologies can provide divergent evaluations of surgical outcomes. We compared postoperative adverse event reporting on the same patients using 2 classification systems: the retrospectively recorded American College of Surgeons (ACS) NSQIP and the prospectively collected Thoracic Morbidity and Mortality (TM&M) system. STUDY DESIGN: Using the TM&M system, complications and deaths were documented daily by fellows and reviewed weekly by staff for all thoracic surgical cases conducted at our institution (April 1, 2010 to December 31, 2011). The ACS NSQIP recording was performed 30 to 120 days after index surgery by trained surgical clinical reviewers on a systemic sampling of major cases during the same time period. Univariate analyses of the data were performed. RESULTS: During the study period, 1,788 thoracic procedures were performed (1,091 were designated "major," as per ACS NSQIP inclusion criteria). The ACS NSQIP evaluated 182 of these procedures, representing 21.1% and 16.7% of patients and procedures, respectively. Mortality rates were 1.4% in TM&M vs 2.2% in ACS NSQIP (p = 0.42). Total patients and procedures with complications reported were 24.4% and 31.1% by TM&M vs 20.2% and 39.0% by ACS NSQIP (p = 0.23 and 0.03), respectively. Rates of reported cardiac complications were higher in TM&M vs ACS NSQIP (5.8% vs 1.1%; p = 0.01), and wound complications were lower (2.5% vs 6.0%; p = 0.01). CONCLUSIONS: Although overall rates were similar, significant differences in collection, definitions, and classification of postoperative adverse events were observed when comparing TM&M and ACS NSQIP. Although both systems offer complementary value, harmonization of definitions and severity classification would enhance quality-improvement programs.