Adding Patient-Reported Outcomes to the American College of Surgeons National Surgical Quality Improvement Program: Results of the First 33,842 Patients from 65 Hospitals.

OBJECTIVES: To investigate the initial set of patient-reported outcomes (PROs) in the ACS 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 ACS conducted a demonstration project to capture PROs into the NSQIP to complement clinical data. METHODS: From 2/2020-3/2023, 65 hospitals collected PROMIS 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 one standard deviation (1-SD) worse than national benchmarks. RESULTS: Overall, 33842 patients completed the PROMIS measures a median 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 thus remains a tremendous quality opportunity.

New Onset Geriatric Syndromes and One-year Outcomes Following Elective Gastrointestinal Cancer Surgery.

OBJECTIVE: To assess whether older adults who develop geriatric syndromes following elective gastrointestinal surgery have poorer 1-year outcomes. BACKGROUND: Within 10 years, 70% of all cancers will occur in older adults ≥65 years old. The rise in older adults requiring major surgery has brought attention to age-related complications termed geriatric syndromes. However, whether postoperative geriatric syndromes are associated with long-term outcomes is unclear. METHODS: A population-based retrospective cohort study using the New York State Cancer Registry and the Statewide Planning and Research Cooperative System was performed including patients >55 years with pathologic stage I-III esophageal, gastric, pancreatic, colon, or rectal cancer who underwent elective resection between 2004 and 2018. Those aged 55 to 64 served as the reference group. The exposure of interest was a geriatric syndrome [fracture, fall, delirium, pressure ulcer, depression, malnutrition, failure to thrive, dehydration, or incontinence (urinary/fecal)] during the surgical admission. Patients with any geriatric syndrome within 1 year of surgery were excluded. Outcomes included incident geriatric syndrome, 1-year days alive and out of the hospital, and 1-year all-cause mortality. RESULTS: In this study, 37,998 patients with a median age of 71 years without a prior geriatric syndrome were included. Of those 65 years or more, 6.4% developed a geriatric syndrome. Factors associated with an incident geriatric syndrome were age, alcohol/tobacco use, comorbidities, neoadjuvant therapy, ostomies, open surgery, and upper gastrointestinal cancers. An incident geriatric syndrome was associated with a 43% higher risk of 1-year mortality (hazard ratio, 1.43; 95% confidence interval, 1.27-1.60). For those aged 65+ discharged alive and not to hospice, a geriatric syndrome was associated with significantly fewer days alive and out of hospital (322 vs 346 days, P < 0.0001). There was an indirect relationship between the number of geriatric syndromes and 1-year mortality and days alive and out of the hospital after adjusting for surgical complications. CONCLUSIONS: Given the increase in older adults requiring major surgical intervention, and the establishment of geriatric surgery accreditation programs, these data suggest that morbidity and mortality metrics should be adjusted to accommodate the independent relationship between geriatric syndromes and long-term outcomes.

Think Twice: De-implementation of Laboratory Testing After Colorectal Surgery.

BACKGROUND: Clinically unindicated laboratory testing contributes to low-value care. Most postoperative day 1 laboratory tests after colorectal surgery are normal. However, no published interventions have shown that reducing overall postoperative laboratory testing is safe. OBJECTIVE: This study aimed to investigate the impact of reducing postoperative laboratory testing after colorectal surgery. DESIGN: This is a quality improvement study. SETTINGS: The study was conducted at an academic center with an enhanced recovery after surgery program that included 5 daily laboratory tests until discharge. PATIENTS: All adults undergoing colorectal or small-bowel surgery formed intervention and nonintervention cohorts based on surgeons who chose to opt into the study. Preimplementation (November 2019-October 2021), there were 545 intervention and 577 nonintervention patients. Postimplementation (November 2021-March 2023), there were 448 intervention and 437 nonintervention patients. INTERVENTIONS: The intervention included 3 postoperative day 1 laboratory tests and subsequent clinically indicated laboratory tests. MAIN OUTCOME MEASURES: Outcome measures included laboratory tests and days free of laboratory work. RESULTS: Postintervention, the intervention group had a 33% reduction in laboratory tests per hospital stay, a 26% reduction in laboratory tests per day, and a 49% increase in laboratory test-free days. There was no difference in length of stay (4 vs 4; p = 0.79) or readmissions (14.9% vs 12.9%; p = 0.39). The nonintervention group had no significant changes in laboratory work or laboratory test-free days, with no differences in length of stay (4 vs 4; p = 0.49) or readmissions (11.1% vs 11.0%; p = 0.96). LIMITATIONS: Demographics and complication rates were not reported. CONCLUSIONS: An intervention targeting reflexive laboratory testing after colorectal surgery resulted in safe, significant, sustained reductions in postoperative laboratory work, with substantial cost savings. These findings prompted a change in the laboratory order set to an opt-out system, and laboratory work reduction approaches have been implemented within other surgical divisions. Continuation and spread of these efforts are instrumental for prioritization of high-value surgical care. See Video Abstract . PINSELO DOS VECES ELIMINACIN DE LAS PRUEBAS DE LABORATORIO DESPUS DE LA CIRUGA COLORRECTAL: ANTECEDENTES:Las pruebas de laboratorio clínicamente no indicadas contribuyen a una atención de bajo valor. La mayoría de los análisis de laboratorio del primer día post operatorios de una cirugía colorrectal son normales. Sin embargo, ninguna intervención publicada ha demostrado que reducir las pruebas de laboratorio post operatorias generales sea seguro.OBJETIVO:El objetivo de este estudio fue investigar el impacto de reducir las pruebas de laboratorio pos toperatorias después de la cirugía colorrectal.DISEÑO:Este es un estudio de mejora de la calidad.AJUSTES:El estudio se llevó a cabo en un centro académico con un programa mejorado de recuperación después de la cirugía que incluye 5 laboratorios diarios hasta el alta.PACIENTES:Todos los adultos sometidos a cirugía colorrectal o de intestino delgado formaron cohortes de intervención y no intervención basadas en los cirujanos que optaron por participar en el estudio. Antes de la implementación (noviembre de 2019 - octubre de 2021) había 545 pacientes con intervención y 577 sin intervención. Después de la implementación (noviembre de 2021 - marzo de 2023) hubo 448 pacientes con intervención y 437 sin intervención.INTERVENCIONES:La intervención incluyó 3 laboratorios post operatorios del primer día y laboratorios posteriores clínicamente indicados.PRINCIPALES MEDIDAS DE RESULTADO:Las medidas de resultado incluyeron pruebas de laboratorio y días sin laboratorio.RESULTADOS:Después de la intervención, el grupo de intervención tuvo una reducción del 33 % en laboratorios por estancia hospitalaria, una reducción del 26 % en laboratorios por día y un aumento del 49 % en los días sin laboratorio. No hubo diferencias en la duración de la estancia hospitalaria (4 frente a 4; p = 0,79) ni en los reingresos (14,9% frente a 12,9%; p = 0,39). El grupo de no intervención no tuvo cambios significativos en el trabajo de laboratorio o en los días sin laboratorio, sin diferencias en la duración de la estadía (4 versus 4; p = 0,49) o reingresos (11,1% versus 11,0%; p = 0,96).LIMITACIONES:No se informaron datos demográficos ni tasa de complicaciones.CONCLUSIONES:Una intervención dirigida a pruebas de laboratorio reflexivas después de la cirugía colorrectal resultó en reducciones seguras, significativas y sostenidas en el trabajo de laboratorio post operatorio, con ahorros sustanciales de costos. Estos hallazgos provocaron un cambio en el orden del laboratorio establecido hacia un sistema de exclusión voluntaria, y se han implementado enfoques de reducción del trabajo de laboratorio en otras divisiones quirúrgicas. La continuación y difusión de estos esfuerzos son fundamentales para priorizar la atención quirúrgica de alto valor. (Traducción-Dr. Mauricio Santamaria ).

The Crohn's Disease-Health Index: Development and Evaluation of a Novel Outcome Measure.

OBJECTIVE: We sought to develop and validate the Crohn's Disease-Health Index (CD-HI), a disease-specific, patient-reported outcome measure that serially measures Crohn's disease (CD) symptomatic burden in adults with CD. BACKGROUND: As therapeutic interventions are tested among patients with CD, responsive outcome measures are needed to track disease progression and therapeutic gain during clinical trials. PATIENTS AND METHODS: We conducted a national cross-sectional study of individuals with CD to identify the most prevalent and impactful symptoms of CD. The most relevant symptoms were included in the CD-HI. We used factor analysis, qualitative patient interviews, test-retest reliability evaluation, and known group validity testing to evaluate and optimize the CD-HI. RESULTS: The CD-HI contains 12 subscales that comprehensively measure CD burden using the patient's perspective. Fifteen adults with CD beta tested the CD-HI and found the instrument to be clear, easy to use, and relevant to them. Twenty-three adults with CD participated in an assessment of test-retest reliability, which indicated high reliability of individual questions, subscales, and the full instrument (intraclass correlation coefficient = 0.84 for the full instrument). The CD-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.98 for the full instrument). The CD-HI distinguished between groups of individuals with CD known to differ in disease severity. CONCLUSIONS: This research supports the use of the CD-HI as a valid, sensitive, reliable, and relevant patient-reported outcome to determine the multifactorial disease burden of those with CD, assess the relevance and merit of future CD therapies, and support drug labeling claims.

A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study.

OBJECTIVES: Male rectal and anal cancer patients demonstrate high rates of sexual dysfunction. This pilot randomized controlled trial tested a psychoeducational intervention designed to improve psychosexual adjustment. METHODS: Rectal or anal cancer patients were randomized to a Sexual Health Intervention for Men (intervention) or to a referral and information control (control). The intervention included control activities plus 4 sexual health intervention sessions every 4-6 weeks and 3 brief telephone calls timed between these sessions. Assessments were completed pre-intervention (baseline) and 3 months (follow-up 1) and 8 months (follow-up 2) post-intervention. Differences were assessed with statistical significance and Cohen's d effect sizes (d = 0.2, small effect; d = 0.5, moderate effect; d = 0.8, large effect). RESULTS: Ninety subjects enrolled. Forty-three participants completed at least 1 follow-up assessment (intervention, n = 14; control n = 29). At follow-up 1, men in intervention, compared to control, improved on all domains of the International Index of Erectile Function (IIEF) (p < 0.001 to p < 0.05) and demonstrated large effects (d = 0.8 to d = 1.5). Similarly, at follow-up 2, changes in all domains of the IIEF except the orgasm domain were either statistically significant or marginally statistically significant (p = 0.01 to p = 0.08) and demonstrated moderate to large treatment effects for intervention versus control (d = 0.5 to d = 0.8). Men in the intervention, compared to control, demonstrated decreased sexual bother at follow-up 1 (p = 0.009, d = 1.1), while Self-Esteem and Relationship (SEAR) total scores and the SEAR sexual relationship subscale demonstrated moderate increases for intervention versus control (d = 0.4 to d = 0.6). SIGNIFICANCE OF RESULTS: This study provides initial evidence for combining a psychoeducational intervention with medical interventions to address sexual dysfunction following rectal and anal cancer. Trials register number: NCT00712751 (date of registration: 7/10/2008).

Low Preoperative Serum Creatinine is Common and Associated With Poor Outcomes After Nonemergent Inpatient Surgery.

OBJECTIVE: To assess the association between low preoperative serum creatinine and postoperative outcomes. BACKGROUND: The association between low creatinine and poor surgical outcomes is not well understood. METHODS: We identified patients with creatinine in the 7 days preceding nonemergent inpatient surgery in the American College of Surgeons National Surgical Quality Improvement Program database from 2005 to 2020. Multivariable logistic regression was used to examine the association between creatinine and 30-day mortality and major complications. RESULTS: Of 1,809,576 patients, 27.8% of males and 23.5% of females had low preoperative serum creatinine, 14.6% experienced complications, and 1.2% died. For males, compared with the reference creatinine of 0.85 to 1.04, those with serum creatinine ≤0.44 had 55% increased odds of mortality [ adjusted odds ratio (aOR), 1.55; 95% CI, 1.29-1.86] and 82% increased odds of major complications (aOR, 1.82; 95% CI, 1.69-1.97). Similarly, for females, compared with the reference range of 0.65 to 0.84, those with serum creatinine ≤0.44 had 49% increased odds of mortality (aOR, 1.49; 95% CI, 1.32-1.67) and 76% increased odds of major complications (aOR, 1.76; 95% CI, 1.70-1.83). These associations persisted for the total cohort, among those with mildly low albumin, and for those with creatinine values measured 8 to 30 days preoperatively. CONCLUSIONS: A low preoperative creatinine is common and associated with poor outcomes after nonemergent inpatient surgery. A low creatinine may help identify high-risk patients who may benefit from further evaluation and optimization.

A Novel Use for Pelvic MRI Scans to Estimate Lean Body Mass and Screen for Sarcopenia in Patients With Rectal Cancer.

BACKGROUND: Sarcopenia, the combination of low lean body mass and decreased muscle strength, is associated with significant morbidity and mortality among patients with colorectal cancer. Standard methods for assessing lean body mass and muscle strength, such as bioelectric impedance analysis and handgrip dynamometry, are rarely obtained clinically. Per National Cancer Center Network recommendations, pelvic MRI is routinely collected for staging and surveillance among patients with rectal cancer. However, there are no data assessing the relationship of pelvic MRI lean body mass measurements at the fifth lumbar vertebrae with bioelectric impedance analysis, handgrip strength, or abdominal CT in patients with rectal cancer. Therefore, we aimed to assess whether pelvic MRI lean body mass correlates with a standard for lean body mass measurement (bioelectric impedance analysis), muscle function (handgrip strength), and an imaging modality frequently used in the literature to identify sarcopenia (abdominal CT at the third lumbar vertebrae). IMPACT OF INNOVATION: Lean body mass measurements from routinely collected pelvic MRI at the fifth lumbar vertebrae accurately and reproducibly estimate lean body mass and modestly correlate with handgrip strength. Rectal cancer pelvic MRI may be repurposed for identifying sarcopenia without increasing inconvenience, ionizing radiation exposure, or expenditure to patients with rectal cancer. TECHNOLOGY, MATERIALS, AND METHODS: Patients with locally advanced rectal cancer with pretreatment bioelectric impedance analysis and handgrip strength measurements within 3 months of their staging pelvic MRI were eligible. Axial skeletal muscle areas were segmented using T1-weighted series pelvic MRI at the fifth lumbar vertebrae and abdominal CT at the third lumbar vertebrae using Slice-O-Matic (Tomovision, Montreal, Canada). Lean body mass (kilograms) was derived from skeletal muscle area with standard equations. Handgrip strength (kilograms) was the maximum of 3 dominant hand attempts in the standing anatomical position. The primary outcome was the agreement between lean body mass measured by pelvic MRI (at the fifth lumbar vertebrae) and bioelectric impedance analysis. Secondary outcomes included the concordance of pelvic MRI lean body mass (at the fifth lumbar vertebrae) with abdominal CT (at the third lumbar vertebrae) and handgrip strength. Additionally, the intra- and interobserver validity, internal consistency, and the mean difference (bias) between lean body mass measurements by pelvic MRI and bioelectric impedance analysis were evaluated. PRELIMINARY RESULTS: Sixteen patients were eligible. The average lean body mass was similar and consistent across 2 observers between bioelectric impedance analysis and pelvic MRI. There was a strong correlation between lean body mass measured on pelvic MRI, bioelectric impedance analysis, and abdominal CT. The reliability of 2 pelvic MRI lean body mass measurements (2 weeks apart by blinded observers) and the correlation of lean body mass between pelvic MRI and bioelectric impedance analysis was strong. Inter- and intraobserver correlation, reliability, and internal consistency were strong for the entire cohort. There was a moderate correlation between pelvic MRI lean body mass and handgrip strength. CONCLUSIONS: Lean body mass measured at the fifth lumbar vertebrae on pelvic MRI is reproducible and correlates strongly with measurements from bioelectric impedance analysis (standard) and abdominal CT at the third lumbar vertebrae and modestly with handgrip strength. These data suggest that MRI lean body mass measurements may be a method to screen patients with rectal cancer for sarcopenia. FUTURE DIRECTIONS: Future studies may evaluate changes in lean body mass on serial pelvic MRI studies among patients with rectal cancer.

Conversations for providers caring for patients with rectal cancer: Comparison of long-term patient-centered outcomes for patients with low rectal cancer facing ostomy or sphincter-sparing surgery.

For some patients with low rectal cancer, ostomy (with elimination into a pouch) may be the only realistic surgical option. However, some patients have a choice between ostomy and sphincter-sparing surgery. Sphincter-sparing surgery has been preferred over ostomy because it offers preservation of normal bowel function. However, this surgery can cause incontinence and bowel dysfunction. Increasingly, it has become evident that certain patients who are eligible for sphincter-sparing surgery may not be well served by the surgery, and construction of an ostomy may be better. No validated assessment tool or decision aid has been published to help newly diagnosed patients decide between the two surgeries or to help physicians elicit long-term surgical outcomes. Furthermore, comparison of long-term outcomes and late effects after the two surgeries has not been synthesized. Therefore, this systematic review summarizes controlled studies that compared long-term survivorship outcomes between these two surgical groups. The goals are: 1) to improve understanding and shared decision-making among surgeons, oncologists, primary care providers, patients, and caregivers; 2) to increase the patient's participation in the decision; 3) to alert the primary care provider to patient challenges that could be addressed by provider attention and intervention; and 4) ultimately, to improve patients' long-term quality of life. This report includes discussion points for health care providers to use with their patients during initial discussions of ostomy and sphincter-sparing surgery as well as questions to ask during follow-up examinations to ascertain any long-term challenges facing the patient. CA Cancer J Clin 2016;66:387-397. © 2016 American Cancer Society.

Major renal morbidity following elective rectal cancer resection by the type of diverting ostomy.

AIM: Patients with rectal cancer often undergo faecal diversion, yet the existing literature cursorily reports renal sequelae by the type of ostomy. We aimed to determine whether the presence of an ileostomy or colostomy was associated with postoperative renal morbidity. METHODS: We identified patients with rectal cancer undergoing elective resection with primary anastomosis without diversion, with an ileostomy and with a colostomy by 21 possible procedures in the colectomy- and proctectomy-specific National Surgical Quality Improvement Program files. The odds of major renal events (renal failure [dialysis initiated] or progressive renal insufficiency [>2 mg/dl increase in creatinine without dialysis]), progressive renal insufficiency alone and readmissions were assessed using propensity score weighting and logistic regression. RESULTS: Of 15 075 patients (63.7% Stage II-III, 85.7% creatinine values obtained ≤30 days preoperatively), 37.7% were not diverted, 39.5% had an ileostomy and 22.9% a colostomy. Compared to non-diverted patients, diversion was associated with major renal events (ileostomy, odds ratio [OR] 2.1, 95% confidence interval [CI] 1.6-2.9; colostomy, OR 1.8, 95% CI 1.3-2.5), progressive renal insufficiency (ileostomy, OR 2.5, 95% CI 1.7-3.5; colostomy, OR 2.0, 95% CI 1.4-2.9), readmissions for renal failure (ileostomy, OR 3.2, 95% CI 2.1-5.0; colostomy, OR 2.5, 95% CI 1.6-4.1) and readmissions for fluid/electrolyte abnormalities (ileostomy, OR 2.3, 95% CI 1.6-3.3; colostomy, OR 1.8, 95% CI 1.2-2.6). CONCLUSION: Diverting ostomies after elective rectal cancer resection are strongly associated with renal morbidity. The decision to divert is complex, and it is unclear whether select patients may benefit from a colostomy from a renal perspective.

Is there an outcome benefit? Patient engagement technology in addition to the electronic medical record patient portal following elective colorectal surgery.

BACKGROUND: Patient engagement technologies (PET) are an area of growing innovation and investment, but whether PET use in the setting of electronic medical record (EMR) supported patient portals are associated with improved outcomes is unknown. Therefore, we assessed PET and EMR activation among patients undergoing elective colorectal surgery on an enhanced recovery pathway. METHODS: We identified adults undergoing elective colorectal surgery between 1/2017 and 7/2021. EMR activations were assessed and patients were considered PET users if they used a proprietary PET application. Multivariable logistic regression was used to identify factors associated with PET use and determine whether the level of engagement (percentage of messages read by the patient) was associated with 30-day outcomes. RESULTS: 484 patients (53.5% PET users, 81.6% with an activated EMR patient portal, 30.8% ≥ 70 years of age) were included. PET users were younger, more likely to have their EMR portal activated and had decreased odds of prolonged length of stay [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.4-0.8]. Among patients ≥ 70 years, PET users had reduced odds of readmissions (OR 0.2, 95% CI 0.1-0.9) compared to PET non-users. The most engaged PET users had decreased morbidity (OR 0.2, 95% CI 0.1-0.8) and readmissions (OR 0.3, 95% CI 0.1-0.8) compared to the least engaged PET users. CONCLUSION: When controlling for EMR activation, patients who use PET, specifically those with higher levels of engagement or aged ≥ 70, have improved outcomes following elective colorectal surgery. Interventions aimed at increasing the adoption of PET among older adults may be warranted.

Epidemiology and healthcare utilization for rectal foreign bodies in United States adults, 2012-2021.

INTRODUCTION: Presentations to the emergency department for rectal foreign bodies are common, but there is little epidemiologic information on this condition. This limits the ability to provide evidence-based education to trainees regarding the populations affected, the types and frequency of foreign bodies, and factors associated with hospitalization. To address this, we analyzed national estimates of emergency department presentations for rectal foreign bodies from 2012 to 2021 in the US. METHODS: We queried the National Electronic Injury Surveillance System for any injury to the 'pubic region' or 'lower trunk' with an accompanying diagnosis of foreign body, puncture, or laceration. Two authors manually reviewed all clinical narratives to identify cases of rectal foreign bodies. National estimates were determined using weighting and strata variables, incidence rates calculated using census data, trends assessed by linear regression, and factors associated with hospitalization identified by multivariable logistic regression. RESULTS: From 885 cases, there were an estimated 38,948 (95% CI, 32,040-45,856) emergency department visits for rectal foreign bodies among individuals ≥15 years from 2012 to 2021. The average age was 43, 77.8% were male, 55.4% of foreign bodies were sexual devices, and 40.8% required hospitalization. The annual incidence of presentations for rectal foreign bodies increased from 1.2 in 2012 to 1.9 per 100,000 persons in 2021 (R2 = 0.84, p < 0.01). Males have a bimodal age distribution peaking in the fifth decade, while females have a right-skewed age distribution peaking in the second decade. Female sex (odds ratio [OR] 0.4; 95% confidence interval [CI], 0.2-0.6) and, compared to sexual devices, balls/marbles (OR 0.2; 95% CI, 0.05-0.6) or drugs/paraphernalia (OR 0.1; 95% CI, 0.05-0.4) are associated with a reduced odds of hospitalization. CONCLUSIONS: Presentations to the emergency department for rectal foreign bodies increased for males and females from 2012 to 2021 in the United States. These epidemiologic estimates for a complex form of anorectal trauma provide preclinical information for emergency medicine, surgery, and radiology trainees.

Survival After Induction Chemotherapy and Chemoradiation Versus Chemoradiation and Adjuvant Chemotherapy for Locally Advanced Rectal Cancer.

BACKGROUND: Total neoadjuvant therapy (TNT) improves tumor response in locally advanced rectal cancer (LARC) patients compared to neoadjuvant chemoradiotherapy alone. The effect of TNT on patient survival has not been fully investigated. MATERIALS AND METHODS: This was a retrospective case series of patients with LARC at a comprehensive cancer center. Three hundred and eleven patients received chemoradiotherapy (chemoRT) as the sole neoadjuvant treatment and planned adjuvant chemotherapy, and 313 received TNT (induction fluorouracil and oxaliplatin-based chemotherapy followed by chemoradiotherapy in the neoadjuvant setting). These patients then underwent total mesorectal excision or were entered in a watch-and-wait protocol. The proportion of patients with complete response (CR) after neoadjuvant therapy (defined as pathological CR or clinical CR sustained for 2 years) was compared by the χ2 test. Disease-free survival (DFS), local recurrence-free survival, distant metastasis-free survival, and overall survival were assessed by Kaplan-Meier analysis and log-rank test. Cox regression models were used to further evaluate DFS. RESULTS: The rate of CR was 20% for chemoRT and 27% for TNT (P=.05). DFS, local recurrence-free survival, metastasis-free survival, and overall survival were no different. Disease-free survival was not associated with the type of neoadjuvant treatment (hazard ratio [HR] 1.3; 95% confidence interval [CI] 0.93-1.80; P = .12). CONCLUSIONS: Although TNT does not prolong survival than neoadjuvant chemoradiotherapy plus intended postoperative chemotherapy, the higher response rate associated with TNT may create opportunities to preserve the rectum in more patients with LARC.

Patient-Reported Impact of Symptoms in Crohn's Disease.

INTRODUCTION: Patients with Crohn's disease (CD) experience a variety of symptoms that significantly affect their lives. In this study, we (i) ascertain the most prevalent and impactful symptoms in CD and (ii) identify modifying factors that are associated with a higher disease burden in CD. METHODS: We conducted semistructured interviews with adult participants with CD to determine what issues have the greatest impact on their lives. Next, we conducted a large cross-sectional study of individuals with CD to determine the prevalence and relative importance of those symptoms and themes and to identify the demographic features that are associated with a higher disease burden. RESULTS: Sixteen individuals with CD provided 792 direct quotes regarding their symptomatic burden. Four hundred three people with CD participated in our cross-sectional study. The symptomatic themes with the highest prevalence in CD were gastrointestinal issues (93.0%), fatigue (86.4%), dietary restrictions (77.9%), and impaired sleep or daytime sleepiness (75.6%). The symptomatic themes that had the greatest impact on patients' lives (0-4 scale) related to fatigue (1.82), impaired sleep or daytime sleepiness (1.71), gastrointestinal issues (1.66), and dietary restrictions (1.61). Symptomatic theme prevalence was strongly associated with a higher number of soft stools per day, greater number of bowel movements per day, missed work, employment and disability status, and having perianal disease. DISCUSSION: Patients with CD experience numerous symptoms that affect their daily life. These symptoms, some underrecognized, vary based on disease and demographic characteristics and represent potential targets for future therapeutic interventions.

Acute kidney injury is a common and significant complication following ileostomy formation.

AIM: The aim was to characterize the incidence and short-term prognostic value of an acute kidney injury (AKI) during the admission where an ileostomy is formed. METHODS: Adults with a baseline serum creatinine measurement discharged alive after ileostomy formation from 2014 to 2016 were included. All patients had daily basic metabolic panels and the Kidney Diseases Improving Global Outcomes criteria were used to determine the presence and severity of any AKI. Dehydration was defined by a single urine abnormality or clinical criteria combined with an objective abnormality in vitals or basic metabolic panels. RESULTS: Of 262 patients, 19.4% sustained an AKI (74.5% Stage I, 15.7% Stage II, 9.8% Stage III) during the index admission. Predictors of incident AKI were increasing age, male sex, higher baseline creatinine and open surgery. Patients with AKI had significantly longer length of stay and 45% had creatinine <1.0 mg/dl at discharge. Of the total cohort, 11% were readmitted with dehydration and the independent predictors were AKI during the index admission, high ileostomy output, age >65 years, male sex and prior ileostomy. Of those readmitted with dehydration, 79% had AKI at readmission. CONCLUSIONS: Nearly 20% of patients with ileostomies develop an AKI during the index admission with almost half resolving by discharge. Patients with AKIs are at high risk for 30-day dehydration-related readmission and AKI is present in nearly 80% of those readmitted with dehydration. Since AKI is objective, based on routine laboratory measures, and has known prognostic value it is probably a more robust outcome than dehydration for researchers, surgeons and patients.

A qualitative analysis of caregiver burden during the recovery process in ambulatory cancer surgery.

PURPOSE: Cancer impacts caregivers as well as patients. Ambulatory oncology surgeries requiring a short hospital stay place additional responsibility on informal caregivers as they help patients navigate their post-operative recovery at home, and determine if symptoms are expected or emergent. Our objective was to explore the experience of informal caregivers during patients' ambulatory cancer surgery and then recovery at home with remote monitoring of symptoms via web-based patient-reported outcomes questionnaire ("Recovery Tracker"). METHODS: Semi-structured interviews were conducted with caregivers from a larger sample participating in a randomized trial of the Recovery Tracker. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software (QSR International Inc.). Recruitment was conducted iteratively to ensure a heterogenous sample and thematic saturation. RESULTS: Twenty-three semi-structured interviews were conducted. Four main themes emerged: (1) Predictability reduced stress among caregivers; (2) Unexpected events caused stress for caregivers; (3) The importance of a caregiver being present during the recovery process; and (4) Caregiver involvement in remote monitoring of symptoms was minimal. CONCLUSION: Caregivers report not being overly burdened by the ambulatory surgery process, but they are very sensitive to any deviations from what they expected to happen. Further research and clinical practice on caregivers in the ambulatory setting should focus on how to set expectations and avoid unexpected events.

Is robotic utilization associated with increased minimally invasive colorectal surgery rates? Surgeon-level evidence.

BACKGROUND: It is unclear whether robotic utilization has increased overall minimally invasive colorectal surgery rates or if robotics is being adopted instead of laparoscopy. The goal was to evaluate whether increasing robotic surgery utilization is associated with increased rates of overall colorectal minimally invasive surgery. METHODS: The Statewide Planning and Research Cooperative System (New York) was used to identify patients undergoing elective colectomy or proctectomy from 2009 to 2015. Individual surgeons were categorized as having increasing or non-increasing robotic utilization (IRU or non-IRU, respectively) based on the annual increase in the proportion of robotic surgery performed. The odds of surgical approach across the study period were evaluated with multinomial regression. RESULTS: Among 72,813 resections from 2009 to 2015, minimally invasive-surgery increased (47-61%, p < 0.0001). For colectomy, overall minimally invasive-surgery rates increased (54-66%, p < 0.0001), laparoscopic remained stable (53-54%), and robotics increased (1-12%). For proctectomy, overall minimally invasive-surgery rates increased (22-43%, p < 0.0001), laparoscopic remained stable (20-21%), and robotics increased (2-22%). Over the study period, 2487 surgeons performed colectomies. Among 156 surgeons with IRU for colectomies, robotics increased (2-29%), while laparoscopy decreased (67-44%), and open surgery decreased (31-27%). Overall, surgeons with IRU performed minimally invasive colectomies 73% of the time in 2015 versus 69% in 2009. Over the study period, 1131 surgeons performed proctectomies. Among 94 surgeons with IRU for proctectomies, robotics increased (3-42%), while laparoscopy decreased (25-15%), and open surgery decreased (73-44%). Overall, surgeons with IRU performed minimally invasive proctectomy 56% of the time in 2015 versus 27% in 2009. Patients in the latter study period had 57% greater odds of undergoing robotic surgery. CONCLUSIONS: Overall, minimally invasive colorectal resections increased from 2009 to 2015 largely due to increasing robotic utilization, particularly for proctectomies.

A Randomized Controlled Trial Evaluating Electronic Outpatient Symptom Monitoring After Ambulatory Cancer Surgery.

OBJECTIVE: We implemented routine daily electronic monitoring of patient-reported outcomes (PROs) for 10 days after discharge after ambulatory cancer surgery, with alerts to clinical staff for worrying symptoms. We sought to determine whether enhancing this monitoring by adding immediate automated normative feedback to patients regarding expected symptoms would further improve the patient experience. SUMMARY OF BACKGROUND DATA: PRO monitoring reduces symptom severity in cancer patients. In ambulatory cancer surgery, it reduces potentially avoidable urgent care center (UCC) visits, defined as those UCC visits without readmission. METHODS: Patients undergoing ambulatory cancer surgery (n = 2624) were randomized to receive standard PRO monitoring or enhanced feedback. The primary study outcome was UCC visits without readmission within 30 days; secondary outcomes included patient anxiety and nursing utilization. RESULTS: There was no significant difference in the risk of a potentially avoidable UCC visit [1.0% higher in enhanced feedback, 95% confidence interval (CI) -0.2-3.1%; P = 0.12]. There were similarly no significant differences in UCC visits with readmission or readmission overall (P = 0.4 for both). Patients randomized to enhanced feedback demonstrated a quicker reduction in anxiety (P < 0.001) and required 14% (95% CI 8-19%; P < 0.001) and 10% (95% CI 5-16%, P < 0.001) fewer nursing calls over 10 and 30 days postoperatively. CONCLUSIONS: Providing patients with feedback about symptom severity during recovery from ambulatory cancer surgery reduces anxiety and nursing workload without affecting UCC visits or readmissions. These results support wider incorporation of normative feedback in systems for routine PRO monitoring.

P047 The Crohn's Disease-Health Index (CD-HI): Development and Validation of a Novel, Disease-Specific Patient Reported Outcome Measure for Clinical Trials.

BACKGROUND: In preparation for upcoming clinical trials involving patients with Crohn's disease (CD), we examine the validity, reliability and usability of the Crohn's Disease-Health Index (CD-HI). The CD-HI is a multifaceted, disease-specific patient reported outcome measure (PROM) designed to measure CD symptomatic disease burden during clinical trials. As promising therapeutic interventions are being tested among CD patients, there is a clear need for researchers to have access to a valid, sensitive, and reliable patient reported outcome tool to track disease burden. This research describes the development and validation of the CD-HI as an efficient mechanism to quantify how CD patients both feel and function. METHODS: We conducted semi-structured, qualitative interviews with CD patients to identify potential symptoms of importance in CD. We then conducted a large, cross-sectional survey study with CD patients to identify the prevalence and importance of symptoms identified during the prior interviews. Symptom questions in the first version of the CD-HI were selected based on overall frequency and impact in a large population of CD patients, generalizability, and potential to respond to therapeutic intervention. Questions which measured a similar concept were grouped into subscales using factor analysis. The first version of the CD-HI was beta tested to explore the usability and relevance of the instrument to patients. We then performed test-retest reliability of each question and subscale. Lastly, we determined the internal consistency for each subscale and the overall instrument. The CD-HI is now finalized and available for use in upcoming clinical trials. RESULTS: Sixteen adults with CD participated in semi-structured qualitative interviews, providing 792 quotes regarding the symptomatic burden of CD. Four hundred and three adults with CD completed an online survey to determine the prevalence and relative importance of 148 patient identified symptoms. Questions were selected for the CD-HI based on their prevalence and relative importance to CD patients. Sixteen adults with CD participated in beta interview testing to address the usability and relevance of the instrument. Patients found the CD-HI to be clear, highly relevant, and easy to use. Test-retest reliability was conducted with twenty-three adults with CD, where participants completed the CD-HI at baseline and fourteen days later. One question was removed to optimize the overall reliability of the instrument. The final version of the CD-HI contains subscales that measure the following granular areas of CD health: 1) fatigue; 2) dietary restrictions; 3) gastrointestinal health; 4) sleep and daytime sleepiness; 5) bowel and bladder function; 6) emotional health; 7) joint health; 8) pain; 9) neck and back health; 10) activity participation; 11) social health; and 12) skin health. Total CD disease burden is measured using a weighted composite of these subscale scores. CONCLUSION: This research successfully demonstrates the ability of the CD-HI to report valid, reliable, and patient-relevant data as a disease-specific PROM. The CD-HI provides researchers and clinicians with an optimal mechanism to record relevant changes in CD health using the patient's perspective.

The Association between Pathologic Complete Response after Neoadjuvant Chemoradiotherapy and Postoperative Complications.

INTRODUCTION: With growing interest in the watch-and-wait strategy, the benefits of avoiding surgery and its complications must be weighed against possible recurrence and need for salvage surgery. However, the relationship between pathologic complete response (pCR) and postoperative complications has not been well established. METHODS: This is a retrospective study using the National Surgical Quality Improvement Program Proctectomy and Colectomy Procedure-Targeted databases from 2016 to 2018. The association between pCR and major complications, sepsis, anastomotic leak or organ space infection, return to the operating room, or septic shock was analyzed. RESULTS: A total of 3,878 rectal cancer patients who received chemotherapy or radiation therapy within 90 days of surgery were included in this study. The pCR rate was 12.8%. There was no statistically significant association between pCR and major complications (adjusted odds ratio (OR) = 0.48, p = 0.12) after risk adjustment. Those with pCR had no statistically significant association with anastomotic leak or organ space infection, return to the operating room, or septic shock but had significantly lower odds of sepsis (adjusted OR = 0.42, p = 0.03). CONCLUSIONS: It is reassuring that pCR is not associated with postoperative complications and that those with pCR are less likely to have postoperative sepsis after risk adjustment since postoperative sepsis after rectal surgery has been associated with poorer oncologic outcomes.

Association of Patient-reported Experiences and Surgical Outcomes Among Group Practices: Retrospective Cohort Study.

OBJECTIVE: The aim of the study was to determine the association of patient-reported experiences (PREs) and risk-adjusted surgical outcomes among group practices. BACKGROUND: The Centers for Medicare and Medicaid Services required large group practices to submit PREs data for successful participation in the Physician Quality Reporting System (PQRS) using the Consumer Assessment of Healthcare Providers and Systems for PQRS survey. Whether these PREs data correlate with perioperative outcomes remains ill defined. METHODS: Operations between January 1, 2014 and December 31, 2016 in the American College of Surgeons' National Surgical Quality Improvement Program registry were merged with 2015 Consumer Assessment of Healthcare Providers and Systems for PQRS survey data. Hierarchical logistic models were constructed to estimate associations between 7 subscales and 1 composite score of PREs and 30-day morbidity, unplanned readmission, and unplanned reoperation, separately, while adjusting for patient- and procedure mix. RESULTS: Among 328 group practices identified, patients reported their experiences with clinician communication the highest (mean ±â€Šstandard deviation, 82.66 ±â€Š3.10), and with attention to medication cost the lowest (25.96 ±â€Š5.14). The mean composite score was 61.08 (±6.66). On multivariable analyses, better PREs scores regarding medication cost, between-visit communication, and the composite score of experience were each associated with 4% decreased odds of morbidity [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.92-0.99], readmission (OR 0.96, 95% CI 0.93-0.99), and reoperation (OR 0.96, 95% CI 0.93-0.99), respectively. In sensitivity analyses, better between-visit communication remained significantly associated with fewer readmissions. CONCLUSIONS: In these data, patients' report of better between-visit communication was associated with fewer readmissions. More sensitive, surgery-specific PRE assessments may reveal additional unique insights for improving the quality of surgical care.