National Databases for Assessment of Quality.

With the rise in the availability of large health care datasets, database research has become an important tool for colorectal surgeon to assess health care quality and implement practice changes. In this chapter, we will discuss the benefits and drawbacks of database research for quality improvement, review common markers of quality for colorectal surgery, provide an overview of frequently used datasets (including Veterans Affairs Surgical Quality Improvement Program, National Surgical Quality Improvement Project, National Cancer Database, National Inpatient Sample, Medicare Data, and Surveillance, Epidemiology, and End Results), and look ahead to the future of database research for the improvement of quality.

Adherence to Enhanced Recovery Protocols in NSQIP and Association With Colectomy Outcomes.

OBJECTIVE: To evaluate the effect of protocol adherence on length of stay (LOS) and recovery-specific outcomes after colectomy. BACKGROUND: Enhanced recovery protocols (ERPs) may decrease postoperative morbidity and LOS; however, the effect of overall protocol adherence remains unclear. METHODS: Using American College of Surgeons' National Surgical Quality Improvement Program colectomy data (July 2014-December 2015) and 13 novel ERP variables, propensity scores were constructed for low (0-5), moderate (6-9), and high adherence (10-13 components). Prolonged LOS (>75th percentile, uncomplicated cases) was modeled with multivariable logistic regression with robust standard errors, adjusted for hospital-level clustering and propensity score. Secondary recovery-specific outcomes were modeled with negative binomial regression. Subgroup analysis was conducted on uncomplicated cases. RESULTS: Among 8139 elective colectomies at 113 hospitals, LOS increased with decreasing adherence (4.3 days [SD 3.3] high adherence vs 7.8 [SD 6.8] low adherence; P < 0.0001). High adherence was associated with fewer complications, including postoperative ileus, compared with moderate (P < 0.0001) and low adherence (P < 0.0001). High-adherence patients achieved recovery milestones earlier (vs low adherence), with return of bowel function at 1.9 (vs 3.7) days, tolerance of diet at 2.4 (vs 5.4) days, and oral pain control at 2.7 (vs 5.0) days (P < 0.0001). Risk-adjusted odds of prolonged LOS were significantly increased for low (odds ratio 2.7, 95% confidence interval 2.0-3.6) and moderate-adherence (odds ratio 1.7, 95% confidence interval 1.4-2.1) groups. In a negative binomial regression, time to recovery was 60% to 95% longer for low versus high adherence (P < 0.0001). CONCLUSIONS: In this large, multi-institutional North American data registry, high adherence to ERPs was associated with earlier recovery, decreased complications, and shorter LOS. ERPs can improve outcomes; however, benefits correlate with adherence.

Does Implementation of Enhanced Recovery after Surgery (ERAS) Protocols in Colorectal Surgery Improve Patient Outcomes?

Enhanced Recovery after Surgery (ERAS) protocols are multimodal perioperative care pathways designed to accelerate recovery by minimizing the physiologic stress of a surgical procedure. Benefits of ERAS implementation in colorectal surgery include reduced length of stay and decreased complications without an increase in readmissions. Though there is evidence associating individual ERAS protocol elements (e.g., preoperative carbohydrate loading, judicious perioperative fluid administration, and early initiation of postoperative nutrition) with improved outcomes, ensuring high compliance with all elements of an ERAS protocol will maximize benefits to the patient. After ERAS implementation, data collection on protocol process measures can help providers target education and interventions to improve protocol compliance and patient outcomes.

Postoperative Delirium as a Target for Surgical Quality Improvement.

OBJECTIVE: To explore hospital-level variation in postoperative delirium using a multi-institutional data source. BACKGROUND: Postoperative delirium is closely related to serious morbidity, disability, and death in older adults. Yet, surgeons and hospitals rarely measure delirium rates, which limits quality improvement efforts. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Geriatric Surgery Pilot (2014 to 2015) collects geriatric-specific variables, including postoperative delirium using a standardized definition. Hierarchical logistic regression models, adjusted for case mix [Current Procedural Terminology (CPT) code] and patient risk factors, yielded risk-adjusted and smoothed odds ratios (ORs) for hospital performance. Model performance was assessed with Hosmer-Lemeshow (HL) statistic and c-statistics, and compared across surgical specialties. RESULTS: Twenty thousand two hundred twelve older adults (≥65 years) underwent inpatient operations at 30 hospitals. Postoperative delirium occurred in 2427 patients (12.0%) with variation across specialties, from 4.7% in gynecology to 13.7% in cardiothoracic surgery. Hierarchical modeling with 20 risk factors (HL = 9.423, P = 0.31; c-statistic 0.86) identified 13 hospitals as statistical outliers (5 good, 8 poor performers). Per hospital, the median risk-adjusted delirium rate was 10.4% (range 3.2% to 27.5%). Operation-specific risk and preoperative cognitive impairment (OR 2.9, 95% confidence interval 2.5-3.5) were the strongest predictors. The model performed well across surgical specialties (orthopedic, general surgery, and vascular surgery). CONCLUSION: Rates of postoperative delirium varied 8.5-fold across hospitals, and can feasibly be measured in surgical quality datasets. The model performed well with 10 to 12 variables and demonstrated applicability across surgical specialties. Such efforts are critical to better tailor quality improvement to older surgical patients.

Hospital Standards to Promote Optimal Surgical Care of the Older Adult: A Report From the Coalition for Quality in Geriatric Surgery.

OBJECTIVE: The aim of this study was to establish high-quality, valid standards to improve surgical care of the older adult. BACKGROUND: The aging population increases demand for high-quality surgical care. Building upon prior guidelines, quality indicators, and pilot projects, the Coalition for Quality in Geriatric Surgery (CQGS) includes 58 diverse stakeholder organizations committed to improving geriatric surgery. METHODS: Using a modified RAND-UCLA Appropriateness Methodology, 44 of 58 CQGS Stakeholders twice rated validity (primary outcome) and feasibility for 308 standards, ranging from goals and decision-making, pre-operative assessment and optimization, perioperative and postoperative care, to transitions of care beyond the acute care hospital. RESULTS: Three hundred six of 308 (99%) standards were rated as valid to improve quality of geriatric surgery. There were 4 sections. Section 1 included 157 (57%) standards and focused on goals and decision-making, preoperative optimization, and transitions into and out of the hospital. Section 2 included 84 (27.3%) standards focused on in-hospital care, across the immediate preoperative, intraoperative, and postoperative phases. Section 3 included 59 (19.1%) standards about program management, including personnel and committee structure, credentialing, and education. Section 4 included 8 (2.6%) standards establishing overarching concepts for data collection and patient follow-up. Two hundred ninety of 308 standards (94.2%) were rated as feasible; 18 (5.8%) were rated as uncertain in feasibility. CONCLUSIONS: CQGS Stakeholders rated the vast majority of standards of care as highly valid (99%) and feasible (94%) for improving the quality of surgical care provided to older adults. Future work will focus on a pilot phase to better understand and address challenges to implementation of the standards.

Effect of Diagnosis on Outcomes in the Setting of Enhanced Recovery Protocols.

BACKGROUND: Implementation of enhanced recovery protocols in colectomy reduces length of stay and morbidity, but it remains unknown whether benefits vary by clinical diagnosis. OBJECTIVE: Outcomes after colectomy in the setting of enhanced recovery protocols were compared for 3 diagnoses: 1) neoplasm, 2) diverticulitis, and 3) IBD. DESIGN: This was a retrospective registry-based cohort study. SETTINGS: Novel enhanced recovery variables were released in the American College of Surgeons National Surgical Quality Improvement Program in 2014. PATIENTS: Patients with enhanced recovery variable data undergoing elective colectomy (July 2014 to December 2015) for neoplasm, diverticulitis, or IBD were included. MAIN OUTCOME MEASURES: The primary outcome of interest was prolonged length of stay. Additional outcomes included surgical site infection, death/serious morbidity, reoperation, readmission, and days to achieve per os pain control, tolerance of a diet, and return of bowel function. RESULTS: We identified 4620 patients with neoplasm, 1730 patients with diverticulitis, and 593 patients with IBD. Patients undergoing colectomy for IBD were more likely to have prolonged length of stay (OR, 1.98; 95% CI, 1.46-2.69), death/serious morbidity (OR, 1.62; 95% CI, 1.13-2.32), and readmission (OR, 1.54; 95% CI, 1.15-2.08) compared with patients with neoplasm. Patients with IBD took longer than patients with neoplasm or diverticulitis to achieve per os pain control (mean, 4.2 days vs 3.4 and 3.5 days, p < 0.001) and tolerate a diet (mean, 4.1 days vs 3.7 and 3.5 days, p < 0.001). No statistically significant differences in outcomes between patients with neoplasm and diverticulitis were seen. LIMITATIONS: There may be heterogeneity among implemented enhanced recovery protocols. CONCLUSIONS: Patients undergoing colectomy for neoplasm and diverticulitis have improved outcomes in comparison with patients undergoing colectomy for IBD. Knowledge of expected outcomes for patients with different diagnoses may inform clinician and patient expectations. See Video Abstract at http://links.lww.com/DCR/A623.

Trends in perioperative outcomes of hospitals performing major cancer surgery.

BACKGROUND AND OBJECTIVES: Cancer surgery outcomes at National Cancer Institute-designated cancer centers (NCI-CCs) have been shown to vary, and have not been uniformly better than outcomes among non-NCI-CCs. We aimed to assess whether NCI-CCs have improved their short-term outcomes over time and whether variation across these centers has changed. METHODS: Patients who underwent colectomy, esophagectomy, hepatectomy, pancreatectomy, and proctectomy for cancer were identified from the 2010 to 2016 American College of Surgeons' National Surgical Quality Improvement Program registry. Hospital trends in risk-adjusted, smoothed observed-to-expected ratios were assessed to evaluate improvement and variation in perioperative complications, stratified by NCI-CC status. RESULTS: Complications occurred in 18.8% of 204 732 patients who underwent major cancer operations at 645 hospitals, and complications occurred in 19.9% of 60,903 patients at 54 NCI-CCs studied. More NCI-CCs than non-NCI-CCs improved over the period (85.2% vs 58.4%, P < 0.001; relative risk [RR] 1.46, 95% confidence interval [CI], 1.28-1.66); this remained significant after adjusting for years of participation (RR 1.33, 95% CI, 1.17-1.51). Variation in performance remained unchanged over time. CONCLUSION: NCI-CCs were detected to have improved over a contemporary seven-year period and to have improved more than non-NCI-CCs. However, NCI-CCs do not uniformly outperform non-NCI-CCs, and variation in perioperative outcomes remains, warranting continued quality improvement efforts targeting cancer-specific operations.

Outcomes of Concurrent Operations: Results From the American College of Surgeons' National Surgical Quality Improvement Program.

OBJECTIVE: To determine whether concurrently performed operations are associated with an increased risk for adverse events. BACKGROUND: Concurrent operations occur when a surgeon is simultaneously responsible for critical portions of 2 or more operations. How this practice affects patient outcomes is unknown. METHODS: Using American College of Surgeons' National Surgical Quality Improvement Program data from 2014 to 2015, operations were considered concurrent if they overlapped by ≥60 minutes or in their entirety. Propensity-score-matched cohorts were constructed to compare death or serious morbidity (DSM), unplanned reoperation, and unplanned readmission in concurrent versus non-concurrent operations. Multilevel hierarchical regression was used to account for the clustered nature of the data while controlling for procedure and case mix. RESULTS: There were 1430 (32.3%) surgeons from 390 (77.7%) hospitals who performed 12,010 (2.3%) concurrent operations. Plastic surgery (n = 393 [13.7%]), otolaryngology (n = 470 [11.2%]), and neurosurgery (n = 2067 [8.4%]) were specialties with the highest proportion of concurrent operations. Spine procedures were the most frequent concurrent procedures overall (n = 2059/12,010 [17.1%]). Unadjusted rates of DSM (9.0% vs 7.1%; P < 0.001), reoperation (3.6% vs 2.7%; P < 0.001), and readmission (6.9% vs 5.1%; P < 0.001) were greater in the concurrent operation cohort versus the non-concurrent. After propensity score matching and risk-adjustment, there was no significant association of concurrence with DSM (odds ratio [OR] 1.08; 95% confidence interval [CI] 0.96-1.21), reoperation (OR 1.16; 95% CI 0.96-1.40), or readmission (OR 1.14; 95% CI 0.99-1.29). CONCLUSIONS: In these analyses, concurrent operations were not detected to increase the risk for adverse outcomes. These results do not lessen the need for further studies, continuous self-regulation and proactive disclosure to patients.

Evaluation of a novel mentor program to improve surgical care for US hospitals.

OBJECTIVE: To evaluate a novel mentor program for 27 US surgeons, charged with improving quality at their respective hospitals, having been paired 1:1 with 27 surgeon mentors through a state-wide quality improvement (QI) initiative. DESIGN: Mixed-methods utilizing quantitative surveys and in-depth semi-structured interviews. SETTING: The Illinois Surgical Quality Improvement Collaborative (ISQIC) utilized a novel Mentor Program to guide surgeons new to QI. PARTICIPANTS: All mentor-mentee pairs received the survey (n = 27). Purposive sampling identified a subset of mentors (n = 8) and mentees (n = 4) for in-depth semi-structured interviews. INTERVENTION: Surgeons with expertise in QI mentored surgeons new to QI. MAIN OUTCOME MEASURES: (i) Quantitative: self-reported satisfaction with the mentor program; (ii) Qualitative: key themes suggesting actions and strategies to facilitate mentorship in QI. RESULTS: Mentees expressed satisfaction with the mentor program (n = 24, 88.9%) and agreed that mentorship is vital to ISQIC (n = 24, 88.9%). Analysis of interview data revealed four key themes: (i) nuances of data management, (ii) culture of quality and safety, (iii) mentor-mentee relationship and (iv) logistics. Strategies from these key themes include: utilize raw data for in-depth QI understanding, facilitate presentations to build QI support, identify opportunities for in-person meetings and establish scheduled conference calls. The mentor's role required sharing experiences and acting as a resource. The mentee's role required actively bringing questions and identifying barriers. CONCLUSIONS: Mentorship plays a vital role in advancing surgeon knowledge and engagement with QI in ISQIC. Key themes in mentorship reflect strategies to best facilitate mentorship, which may serve as a guide to other collaboratives.

Does delayed operation increase morbidity and mortality? An analysis of emergency general surgery procedures.

BACKGROUND: Early operation is assumed to improve outcomes after emergency general surgery (EGS) procedures; however, few data exist to inform this opinion. We aimed to (1) characterize time-to-operation patterns among EGS procedures and (2) test the association between timing and patient outcomes. We hypothesize that patients receiving later operations are at greater risk for mortality and morbidity. METHODS: We performed a retrospective cohort study of the American College of Surgeons National Surgical Quality Improvement Program data for adults aged 18 to 89 years who underwent nonelective intra-abdominal operations (appendectomy, cholecystectomy, small bowel resection, lysis of adhesions, and colectomy) from 2015 to 2020. The primary outcome was 30-day postoperative mortality. Secondary outcomes were serious morbidity and all morbidity. Admission-to-operation timing was calculated and classified as early (≤48 hours) or late (>48 hours). A multivariable logistic regression model adjusted risk estimates for age, comorbidities, frailty (Modified Frailty Index, 5-item score), and other confounders. RESULTS: Of 269,959 patients (mean age, 47.0 years; 48.0% male, 61.6% White), 88.7% underwent early operation, ranging from 70.36% (lysis of adhesions) to 98.67% (appendectomy). Unadjusted 30-day mortality was higher for late versus early operation (6.73% vs. 1.96%; p < 0.0001). After risk adjustment, late operation significantly increased risk for 30-day mortality (odds ratio [OR], 1.545; 95% confidence interval [CI], 1.451-1.644), serious morbidity (OR, 1.464; 95% CI, 1.416-1.514), and all morbidity (OR, 1.468; 95% CI, 1.417-1.520). This mortality risk persisted for all EGS procedures; risk of serious and any morbidity persisted for all procedures except cholecystectomy. CONCLUSION: Late operation significantly increased risk for 30-day mortality, serious morbidity, and all morbidity across a variety of EGS procedures. We believe that these findings will inform decisions regarding timing of EGS operations and allocation of surgical resources. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Using Systems Engineering and Implementation Science to Design an Implementation Package for Preoperative Comprehensive Geriatric Assessment Among Older Adults Having Major Abdominal Surgery: Protocol for a 3-Phase Study.

BACKGROUND: Older Americans, a growing segment of the population, have an increasing need for surgical services, and they experience a disproportionate burden of postoperative complications compared to their younger counterparts. A preoperative comprehensive geriatric assessment (pCGA) is recommended to reduce risk and improve surgical care delivery for this population, which has been identified as vulnerable. The pCGA optimizes multiple chronic conditions and factors commonly overlooked in routine preoperative planning, including physical function, polypharmacy, nutrition, cognition, mental health, and social and environmental support. The pCGA has been shown to decrease postoperative morbidity, mortality, and length of stay in a variety of surgical specialties. Although national guidelines recommend the use of the pCGA, a paucity of strategic guidance for implementation limits its uptake to a few academic medical centers. By applying implementation science and human factors engineering methods, this study will provide the necessary evidence to optimize the implementation of the pCGA in a variety of health care settings. OBJECTIVE: The purpose of this paper is to describe the study protocol to design an adaptable, user-centered pCGA implementation package for use among older adults before major abdominal surgery. METHODS: This protocol uses systems engineering methods to develop, tailor, and pilot-test a user-centered pCGA implementation package, which can be adapted to community-based hospitals in preparation for a multisite implementation trial. The protocol is based upon the National Institutes of Health Stage Model for Behavioral Intervention Development and aligns with the goal to develop behavioral interventions with an eye to real-world implementation. In phase 1, we will use observation and interviews to map the pCGA process and identify system-based barriers and facilitators to its use among older adults undergoing major abdominal surgery. In phase 2, we will apply user-centered design methods, engaging health care providers, patients, and caregivers to co-design a pCGA implementation package. This package will be applicable to a diverse population of older patients undergoing major abdominal surgery at a large academic hospital and an affiliate community site. In phase 3, we will pilot-test and refine the pCGA implementation package in preparation for a future randomized controlled implementation-effectiveness trial. We anticipate that this study will take approximately 60 months (April 2023-March 2028). RESULTS: This study protocol will generate (1) a detailed process map of the pCGA; (2) an adaptable, user-centered pCGA implementation package ready for feasibility testing in a pilot trial; and (3) preliminary pilot data on the implementation and effectiveness of the package. We anticipate that these data will serve as the basis for future multisite hybrid implementation-effectiveness clinical trials of the pCGA in older adults undergoing major abdominal surgery. CONCLUSIONS: The expected results of this study will contribute to improving perioperative care processes for older adults before major abdominal surgery. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59428.

A valid and reliable measure of constipation-related quality of life.

PURPOSE: Few existing measures assess constipation-specific quality of life. This study sought to develop a valid and reliable quality-of-life measure for constipation. METHODS: First, we created a preliminary instrument that assessed quality-of-life domains affected by constipation: body image, eating, mood, and relationships with others. We conducted focus groups both with patients with constipation seeking treatment and the health care providers who treat them. Next, a 59-item questionnaire was given to 240 subjects with constipation (83% female) and 103 healthy volunteers (63% female). Test-retest reliability and discriminant, convergent, and divergent validity were assessed. RESULTS: Exploratory factor analysis revealed four domains: Social Impairment (five items), Distress (six items), Eating Habits (three items), and Bathroom Attitudes (four items). Internal consistency and test-retest reliability for all subscales was high (Cronbach's alpha = 0.89; intraclass correlation coefficient = 0.87). All domains discriminated well between subjects with constipation and healthy volunteers (P < 0.001). Convergent validity was excellent: all subscales correlated highly with the Irritable Bowel Syndrome Quality of Life Scale total score (P < 0.001) and the Medical Outcomes Study Short Form-36 physical component and mental component summary scores (P < 0.001). Scores from our Constipation-Related Quality of Life measure were not significantly correlated with the Social Desirability Scale, demonstrating divergent validity. CONCLUSIONS: Our findings support the reliability and validity of the Constipation-Related Quality of Life measure. Future validation of the Constipation-Related Quality of Life measure for assessing changes in quality of life in response to treatments for constipation is needed.

Procedure-Specific Trends in Surgical Outcomes.

BACKGROUND: Quality improvement efforts have generally focused on hospital benchmarking, and processes and outcomes shared among all operations. However, quality improvement could be inconsistent across different types of operations. The objective of this study was to identify operations needing additional concerted quality improvement efforts by examining their outcomes trends. STUDY DESIGN: Ten procedures (colectomy, esophagectomy, hepatectomy, hysterectomy, pancreatectomy, proctectomy, total hip arthroplasty, total knee arthroplasty, thyroidectomy, and ventral hernia repair) commonly accrued into the American College of Surgeons NSQIP between 2008 and 2015 were included. Trends in risk-adjusted, standardized, smoothed rates were constructed for each procedure across 6 outcomes (mortality, pneumonia, renal failure, surgical site infection, unplanned intubation, and urinary tract infection [UTI]). RESULTS: Of 1,255,575 operations analyzed, the overall unadjusted rate for mortality across all 10 procedures was 1.08%, for pneumonia 1.44%, for renal failure 0.67%, for surgical site infection 5.28%, for unplanned intubation 1.11%, and for UTI 1.86%. Hepatectomy demonstrated the greatest improvement across outcomes (4 of 6 outcomes; 362 adverse events avoided out of 10,000 procedures), and UTI demonstrated the greatest improvement across procedures (8 of 10 procedures; 989 adverse events avoided out of 10,000). For pancreatectomy, rates of mortality, unplanned intubation, and UTI improved, but surgical site infection rates were detected to have significantly increased (p < 0.05). CONCLUSIONS: Hepatectomy was detected to have improved across the greatest number of outcomes, and UTI rates improved significantly across the greatest number of procedures. Surgical site infection rates after pancreatectomy, however, were detected to have increased, identifying an urgent need for additional concerted quality improvement efforts.

Correction to: A systematic review of patient perspectives on surveillance after colorectal cancer treatment.

The original version of this article unfortunately contained a mistake. The online supplementary files are missing. The complete version of online supplementary materials are published with this erratum.