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BackgroundIn the US, disparities in surgical care impede the delivery of uniformly high-quality care to all patients. There is a lack of disparity-sensitive measures related to surgical care. The American College of Surgeons Metrics for Equitable Access and Care in Surgery group, through research and expert consensus, aimed to identify disparity-sensitive measures in surgical care.Study designAn environmental scan, systematic literature review, and subspecialty society surveys were conducted to identify potential disparity-sensitive surgical measures. A modified Delphi process was conducted where panelists rated measures on both importance and validity. In addition, a novel literature-based disparity-sensitive scoring process was used.ResultsWe identified 841 potential disparity-sensitive surgical measures. From these, our Delphi and literature-based approaches yielded a consensus list of 125 candidate disparity-sensitive measures. These measures were rated as both valid and important and were supported by the existing literature.ConclusionThere are profound disparities in surgical care within the US healthcare system. A multidisciplinary Delphi panel identified 125 potential disparity-sensitive surgical measures that could be used to track health disparities, evaluate the impact of focused interventions, and reduce healthcare inequity.

BackgroundThere has been limited evaluation of health-related quality of life (HRQOL) in rectal cancer patients receiving neoadjuvant chemoradiotherapy. HRQOL outcomes in the National Surgical Adjuvant Breast and Bowel Project R-04 trial are examined in this article.MethodsBetween 2004 and 2010, R-04 patients were invited to enroll in the HRQOL substudy, with questionnaires administered before randomization, after completion of chemoradiotherapy, and 1-year after surgery. HRQOL measures included: Functional Assessment of Cancer Therapy for colorectal cancer (FACT-C); Short Form-36v.2 Vitality scale; a treatment-specific symptom scale; and the FACT neurotoxicity scale. A 5-year postsurgery assessment was added to the protocol in 2012. Mixed-effects models examined neoadjuvant therapy treatment effects in the 1-year sample and models that explored associations of host factors and treatment impact on 5-year HRQOL.ResultsA total of 1373 patients completed baseline HRQOL and at least one additional assessment. The average age was 58 years (range, 23-85 years), male (68%), and 59% Stage II. There were no statistically significant differences in HRQOL outcomes by treatment arm, but HRQOL worsened from baseline to postneoadjuvant chemoradiotherapy, with statistically significant effect sizes changes ranging from 0.6 (Vitality) to 0.9 (FACT-C Trial Outcome Index). Neurotoxicity was greater in the oxaliplatin-treated groups. Obese/overweight patients had statistically significantly worse FACT-C Trial Outcome Index scores than did underweight/normal weight groups. At 5 years, younger patients and those with normal baseline weight had statistically significantly better physical function scores and older patients had better mental health outcomes.ConclusionsHRQOL did not differ across the four R-04 treatment arms; however, host factors explained significant variation in posttreatment HRQOL.Clinicaltrialsgov: NCT00058474 (https://ClinicalTrials.gov/ct2/show/NCT00058474).Lay summaryThis article reports on the health-related quality of life (HRQOL) outcomes of patients treated with four different chemotherapy regimens combined with radiation in rectal cancer patients before definitive surgical treatment. There were no significant differences in HRQOL by treatment regimen, but all patients experienced decreased vitality (energy) and physical functioning. By 1 year after treatment, most patients had returned to pretreatment vitality and physical functioning, with the exception of increased neurotoxicity. In a subsample of patients assessed at 5 years after surgery, physical function was better in those who at pretreatment were younger, normal weight, and had better performance status. Mental function was better in those who at pretreatment were older and had better performance status.

Randomized controlled trials (RCTs) represent the gold standard for evidence in clinical medicine because of their ability to account for the effects of unmeasured confounders and selection bias by indication. However, their complexity and immense costs limit their application, and thus the availability of high-quality data to guide clinical care. Registry-based RCTs are a type of pragmatic trial that leverages existing registries as a platform for data collection, providing a low-cost alternative for randomized studies. Herein, we describe the tenets of registry RCTs and the development of the first AHPBA/ACS-NSQIP-based registry trial.

Objective: To investigate the initial set of patient-reported outcomes (PROs) in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) and their associations with 30-day surgical outcomes. Background: PROs provide important information that can be used to improve routine care and facilitate quality improvement. The American College of Surgeons conducted a demonstration project to capture PROs into the NSQIP to complement clinical data. Methods: From February 2020 to March 2023, 65 hospitals collected Patient-Reported Outcomes Measurement Information System measures assessing global health, pain interference, fatigue, and physical function from patients accrued into the NSQIP. Using multivariable mixed regression, we compared the scores of patients with and without 30-day complications and further analyzed scores exceeding 1-SD worse than national benchmarks. Results: Overall, 33842 patients completed the Patient-Reported Outcomes Measurement Information System measures with a median of 58 days (IQR: 47-72) postoperatively. Among patients without complications (n = 31210), 33.9% had PRO scores 1-SD worse than national benchmarks. Patients with complications were 1.7 times more likely to report worse PROs (95% CI: 1.6-1.8). Patients with complications had lower scores for global physical health [adjusted mean difference (AMD): 2.6, 95% CI: 2.2-3.0], lower for global mental health (AMD: 1.8, 95% CI: 1.4-2.2), higher for pain interference (AMD: 2.4, 95% CI: 2.0-2.8), higher fatigue (AMD: 2.7, 95% CI: 2.3-3.1), and lower physical function (AMD: 3.2, 95% CI: 2.8-3.5). Conclusions: Postoperative complications negatively affect multiple key dimensions of patients' health-related quality of life. PROs were well below national benchmarks for many patients, even among those without complications. Identifying solutions to improve PROs after surgery remains a tremendous quality improvement opportunity. [ABSTRACT FROM AUTHOR]

ObjectivesTo evaluate national present-on-admission (POA) reporting for hospital-acquired pressure ulcers (HAPUs) and examine the impact of quality measure exclusion criteria on HAPU rates.Data sources/study settingMedicare inpatient, outpatient, and nursing facility data as well as independent provider claims (2010-2011).Study designRetrospective cross-sectional study.Data collection/extraction methodsWe evaluated acute inpatient hospital admissions among Medicare fee-for-service (FFS) beneficiaries in 2011. Admissions were categorized as follows: (1) no pressure ulcer diagnosis, (2) new pressure ulcer diagnosis, and (3) previously documented pressure ulcer diagnosis. HAPU rates were calculated by varying patient exclusion criteria.Principal findingsAmong admissions with a pressure ulcer diagnosis, we observed a large discrepancy in the proportion of admissions with a HAPU based on hospital-reported POA data (5.2 percent) and the proportion with a new pressure ulcer diagnosis based on patient history in billing claims (49.7 percent). Applying quality measure exclusion criteria resulted in removal of 91.2 percent of admissions with a pressure injury diagnosis from HAPU rate calculations.ConclusionsAs payers and health care organizations expand the use of quality measures, it is important to consider how the measures are implemented, coding revisions to improve measure validity, and the impact of patient exclusion criteria on provider performance evaluation.

BackgroundHospital-acquired pressure injuries (HAPIs) are publicly reported in the USA and used to adjust Medicare payment to acute inpatient facilities. Current methods used to identify HAPIs in administrative claims rely on hospital-reported present-on-admission (POA) data instead of prior patient health information.ObjectiveTo study the reliability of claims data for HAPIs and pressure injury (PI) stage by evaluating diagnostic coding agreement across interfacility transfers.MethodsUsing the 2012 100% Medicare Provider and Analysis Review file, we identified all fee-for-service acute inpatient discharge records with a PI diagnosis among Medicare patients 65 years and older. We then identified additional facility claims (eg, acute inpatient, long-stay inpatient or skilled nursing facility) belonging to the same patient who had either (1) admission within 1day of hospital discharge or (2) discharge within 1day of hospital admission. Multivariable logistic regression and stratified kappa statistics were used to measure coding agreement between transferring and receiving facilities in the presence or absence of a PI diagnosis at the time of patient transfer and PI stage category (early vs advanced).ResultsIn our comparison of claims data between transferring and receiving facilities, we observed poor agreement in the presence or absence of a PI diagnosis at the time of transfer (36.3%, kappa=0.03) and poor agreement in PI stage category (74.3%, kappa=0.17). Among transfers with a POA PI reported by the receiving hospital, only 34.0% had a PI documented at the prior transferring facility.ConclusionsThe observed discordance in PI documentation and staging between transferring and receiving facilities may indicate inaccuracy of HAPI identification in claims data. Future research should evaluate the accuracy of hospital-reported POA data and its impact on PI quality measurement.

Patients managed non-operatively have been excluded from risk-adjusted benchmarking programs, including the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). Consequently, optimal performance evaluation is not possible for specialties like emergency general surgery (EGS) where non-operative management is common. We developed a multi-institutional EGS clinical data registry within ACS NSQIP that includes patients managed non-operatively to evaluate variability in non-operative care across hospitals and identify gaps in performance assessment that occur when only operative cases are considered.Using ACS NSQIP infrastructure and methodology, surgical consultations for acute appendicitis, acute cholecystitis, and small bowel obstruction (SBO) were sampled at 13 hospitals that volunteered to participate in the EGS clinical data registry. Standard NSQIP variables and 16 EGS-specific variables were abstracted with 30-day follow-up. To determine the influence of complications in non-operative patients, rates of adverse outcomes were identified and hospitals were ranked by performance with and then without including non-operative cases.2,091 patients with EGS diagnoses were included, 46.6% with appendicitis, 24.3% with cholecystitis, and 29.1% with SBO. The overall rate of non-operative management was 27.4%, 6.6% for appendicitis, 16.5% for cholecystitis, and 69.9% for SBO. Despite comprising only 27.4% of patients in the EGS Pilot, non-operative management accounted for 67.7% of deaths, 34.3% of serious morbidities, and 41.8% of hospital readmissions. After adjusting for patient characteristics and hospital diagnosis mix, addition of non-operative management to hospital performance assessment resulted in 12 of 13 hospitals changing performance rank, with 4 hospitals changing by 3 or more positions.This study identifies a gap in performance evaluation when non-operative patients are excluded from surgical quality assessment and demonstrates the feasibility of incorporating non-operative care into existing surgical quality initiatives. Broadening the scope of hospital performance assessment to include non-operative management creates an opportunity to improve the care of all surgical patients, not just those who have an operation.III, Prognostic and Epidemiological.

PurposeLittle is known about health-related quality of life (HRQL) in long-term survivors (LTS) of colorectal cancer (CRC).MethodsLong-term CRC survivors (≥5 years) treated in previous National Surgical Adjuvant Breast and Bowel Project trials were recruited from 60 sites. After obtaining consent, a telephone survey was administered, which included HRQL instruments to measure physical health (Instrumental Activities of Daily Living [IADL], SF-12 Physical Component Scale [PCS], SF-36 Vitality Scale), mental health (SF-12 Mental Component Scale [MCS], Life Orientation Test, and Impact of Cancer), and clinical symptoms (Fatigue Symptom Inventory [FSI], European Organization for Research and Treatment of Cancer Colorectal Module [EORTC-CR38], and Brief Pain Inventory). A multivariable model identified predictors of overall quality of life (global health rating).ResultsParticipants (N = 708) had significantly higher HRQL compared with age group-matched non-cancer controls with higher mean scores on SF-12 PCS (49.5 vs. 43.7, p =

ObjectiveThe aim of this study was to determine whether exposure to data from a risk calculator influences surgeons' assessments of risk and in turn, their decisions to operate.BackgroundLittle is known about how risk calculators inform clinical judgment and decision-making.MethodsWe asked a national sample of surgeons to assess the risks (probability of serious complications or death) and benefits (recovery) of operative and nonoperative management and to rate their likelihood of recommending an operation (5-point scale) for 4 detailed clinical vignettes wherein the best treatment strategy was uncertain. Surgeons were randomized to the clinical vignettes alone (control group; n = 384) or supplemented by data from a risk calculator (risk calculator group; n = 395). We compared surgeons' judgments and decisions between the groups.ResultsSurgeons exposed to the risk calculator judged levels of operative risk that more closely approximated the risk calculator value (RCV) compared with surgeons in the control group [mesenteric ischemia: 43.7% vs 64.6%, P < 0.001 (RCV = 25%); gastrointestinal bleed: 47.7% vs 53.4%, P < 0.001 (RCV = 38%); small bowel obstruction: 13.6% vs 17.5%, P < 0.001 (RCV = 14%); appendicitis: 13.4% vs 24.4%, P < 0.001 (RCV = 5%)]. Surgeons exposed to the risk calculator also varied less in their assessment of operative risk (standard deviations: mesenteric ischemia 20.2% vs 23.2%, P = 0.01; gastrointestinal bleed 17.4% vs 24.1%, P < 0.001; small bowel obstruction 10.6% vs 14.9%, P < 0.001; appendicitis 15.2% vs 21.8%, P < 0.001). However, averaged across the 4 vignettes, the 2 groups did not differ in their reported likelihood of recommending an operation (mean 3.7 vs 3.7, P = 0.76).ConclusionsExposure to risk calculator data leads to less varied and more accurate judgments of operative risk among surgeons, and thus may help inform discussions of treatment options between surgeons and patients. Interestingly, it did not alter their reported likelihood of recommending an operation.

ObjectiveTo determine how surgeons' perceptions of treatment risks and benefits influence their decisions to operate.BackgroundLittle is known about what makes one surgeon choose to operate on a patient and another chooses not to operate.MethodsUsing an online study, we presented a national sample of surgeons (N = 767) with four detailed clinical vignettes (mesenteric ischemia, gastrointestinal bleed, bowel obstruction, appendicitis) where the best treatment option was uncertain and asked them to: (1) judge the risks (probability of serious complications) and benefits (probability of recovery) for operative and nonoperative management and (2) decide whether or not they would recommend an operation.ResultsAcross all clinical vignettes, surgeons varied markedly in both their assessments of the risks and benefits of operative and nonoperative management (narrowest range 4%-100% for all four predictions across vignettes) and in their decisions to operate (49%-85%). Surgeons were less likely to operate as their perceptions of operative risk increased [absolute difference (AD) = -29.6% from 1.0 standard deviation below to 1.0 standard deviation above mean (95% confidence interval, CI: -31.6, -23.8)] and their perceptions of nonoperative benefit increased [AD = -32.6% (95% CI: -32.8,--28.9)]. Surgeons were more likely to operate as their perceptions of operative benefit increased [AD = 18.7% (95% CI: 12.6, 21.5)] and their perceptions of nonoperative risk increased [AD = 32.7% (95% CI: 28.7, 34.0)]. Differences in risk/benefit perceptions explained 39% of the observed variation in decisions to operate across the four vignettes.ConclusionsGiven the same clinical scenarios, surgeons' perceptions of treatment risks and benefits vary and are highly predictive of their decisions to operate.

BackgroundLittle is known about hospital use of postacute care after surgery and whether it is related to measures of surgical quality.Research designWe used data merged between a national surgery registry, Medicare inpatient claims, the Area Resource File, and the American Hospital Association Annual Survey (2005-2008). Using bivariate and multivariate analyses, we calculated hospital-level, risk-adjusted rates of postacute care use for both inpatient facilities (IF) and home health care (HHC), and examined the association of these rates with hospital quality measures, including mortality, complications, readmissions, and length of stay.ResultsOf 112,620 patients treated at 217 hospitals, 18.6% were discharged to an IF, and 19.9% were discharged with HHC. Even after adjusting for differences in patient and hospital characteristics, hospitals varied widely in their use of both IF (mean, 20.3%; range, 2.7%-39.7%) and HHC (mean, 22.3%; range, 3.1%-57.8%). A hospital's risk-adjusted postoperative mortality rate or complication rate was not significantly associated with its use of postacute care, but higher 30-day readmission rates were associated with higher use of IF (24.1% vs. 21.2%, P=0.03). Hospitals with longer average length of stay used IF less frequently (19.4% vs. 24.4%, P

ObjectiveTo examine the validity of hybrid quality measures that use both clinical registry and administrative claims data, capitalizing on the strengths of each data source.BackgroundPrevious studies demonstrate substantial disagreement between clinical registry and administrative claims data on the occurrence of postoperative complications. Clinical data have greater validity than claims data for quality measurement but can be burdensome for hospitals to collect.MethodsAmerican College of Surgeons National Surgical Quality Improvement Program records were linked to Medicare inpatient claims (2005-2008). National Quality Forum-endorsed risk-adjusted measures of 30-day postoperative complications or death assessed hospital quality for patients undergoing colectomy, lower extremity bypass, or all surgical procedures. Measures use hierarchical multivariable logistic regression to identify statistical outliers. Measures were applied using clinical data, claims data, or a hybrid of both data sources. Kappa statistics assessed agreement on determinations of hospital quality.ResultsA total of 111,984 patients participated from 206 hospitals. Agreement on hospital quality between clinical and claims data was poor. Hybrid models using claims data to risk-adjust complications identified by clinical data had moderate agreement with all clinical data models, whereas hybrid models using clinical data to risk-adjust complications identified by claims data had routinely poor agreement with all clinical data models.ConclusionsAssessments of hospital quality differ substantially when using clinical registry versus administrative claims data. A hybrid approach using claims data for risk adjustment and clinical data for complications may be a valid alternative with lower data collection burden. For quality measures focused on postoperative complications to be meaningful, such policies should require, at a minimum, collection of clinical outcomes data.