Expert consensus on the management of infusion-related reactions (IRRs) in patients with sickle cell disease (SCD) receiving crizanlizumab: a RAND/UCLA modified Delphi panel.

Crizanlizumab, a monoclonal antibody against P-selectin, has been shown to reduce vaso-occlusive crises (VOCs) compared to placebo in patients ≥ 16 years with sickle cell disease (SCD). However, there have been rare reports of patients experiencing severe pain and subsequent complications within 24 hours of crizanlizumab infusions. These events are defined as infusion-related reactions (IRRs). Informed by current literature and clinical experience, a group of content experts developed clinical guidelines for the management of IRRs in patients with SCD. We used the RAND/University of California, Los Angeles (UCLA) modified Delphi panel method, a valid, reproducible technique for achieving consensus. We present our recommendations for managing IRRs, which depend on patient characteristics including: prior history of IRRs to other monoclonal antibodies or medications, changes to crizanlizumab infusion rate and patient monitoring, pain severity relative to patient's typical SCD crises, and severe allergic symptoms. These recommendations outline how to evaluate and manage IRRs in patients receiving crizanlizumab. Future research should validate this guidance using clinical data and identify patients at risk for these IRRs.

Novel screening metric for the identification of at-risk peripheral artery disease patients using administrative claims data.

Despite high morbidity and mortality associated with peripheral artery disease (PAD), it remains under-diagnosed and under-treated. The objective of this study was to develop a screening metric to identify undiagnosed patients at high risk of developing PAD using administrative data. Commercial claims data from 2010 to 2012 were utilized to develop and internally validate a PAD screening metric. Medicare data were used for external validation. The study population included adults, aged 30 years or older, with new cases of PAD identified using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis/procedure codes or the Healthcare Common Procedure Coding System (HCPCS) codes. Multivariate logistic regression was conducted to determine PAD risk factors used in the development of the screening metric for the identification of at-risk PAD patients. The cumulative incidence of PAD was 6.6%. Sex, age, congestive heart failure, hypertension, chronic renal insufficiency, stroke, diabetes, acute myocardial infarction, transient ischemic attack, hyperlipidemia, and angina were significant risk factors for PAD. A cut-off score of ⩾20 yielded sensitivity, specificity, positive predictive value, negative predictive value, and c-statistics of 83.5%, 60.0%, 12.8%, 98.1%, and 0.78, respectively. By identifying patients at high risk for developing PAD using only administrative data, the use of the current pre-screening metric could reduce the number of diagnostic tests, while still capturing those patients with undiagnosed PAD.

Development and validation of a claims-based algorithm to identify patients with Neuromyelitis Optica Spectrum disorder.

INTRODUCTION: No validated algorithm exists to identify patients with neuromyelitis optica spectrum disorder (NMOSD) in healthcare claims data. We developed and tested the performance of a healthcare claims-based algorithm to identify patients with NMOSD. METHODS: Using medical record data of 101 adults with NMOSD, multiple sclerosis (MS), or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), we tested the sensitivity and specificity of claims-based algorithms developed through interviews with neurologists. We tested the best-performing algorithm's face validity using 2016-2019 data from IBM MarketScan Commercial and Medicare Supplemental databases. Demographics and clinical characteristics were reported. RESULTS: Algorithm inclusion criteria were age ≥ 18 years and (≥1 NMO diagnosis [or ≥ 1 transverse myelitis (TM) and ≥ 1 optic neuritis (ON) diagnosis] and ≥ 1 NMOSD drug) or (≥2 NMO diagnoses ≥90 days apart). Exclusion criteria were MS diagnosis or use of MS-specific drug after last NMO diagnosis or NMOSD drug; sarcoidosis diagnosis after last NMO diagnosis; or use of ≥1 immune checkpoint inhibitor. In medical record billing data of 50 patients with NMOSD, 30 with MS, and 21 with MOGAD, the algorithm had 82.0% sensitivity and 70.6% specificity. When applied to healthcare claims data, demographic and clinical features of the identified cohort were similar to known demographics of NMOSD. CONCLUSIONS: This clinically derived algorithm performed well in medical records. When tested in healthcare claims, demographics and clinical characteristics were consistent with previous clinical findings. This algorithm will enable a more accurate estimation of NMOSD disease burden using insurance claims datasets.

Modified Delphi panel consensus recommendations for management of severe aplastic anemia.

ABSTRACT: Severe aplastic anemia (SAA) is a rare hematologic condition for which there is no clear management algorithm. A panel of 11 experts on adult and pediatric aplastic anemia was assembled and, using the RAND/University of California, Los Angeles modified Delphi panel method, evaluated >600 varying patient care scenarios to develop clinical recommendations for the initial and subsequent management of patients of all ages with SAA. Here, we present the panel's recommendations to rule out inherited bone marrow failure syndromes, on supportive care before and during first-line therapy, and on first-line (initial management) and second-line (subsequent management) therapy of acquired SAA, focusing on when transplant vs medical therapy is most appropriate. These recommendations represent the consensus of 11 experts informed by published literature and experience. They are intended only as general guidance for experienced clinicians who treat patients with SAA and are in no way intended to supersede individual physician and patient decision making. Current and future research should validate this consensus using clinical data. Once validated, we hope these expert panel recommendations will improve outcomes for patients with SAA.

Comprehensive Review on the Clinical Impact of Next-Generation Sequencing Tests for the Management of Advanced Cancer.

PURPOSE: This review summarizes the published evidence on the clinical impact of using next-generation sequencing (NGS) tests to guide management of patients with cancer in the United States. METHODS: We performed a comprehensive literature review to identify recent English language publications that presented progression-free survival (PFS) and overall survival (OS) of patients with advanced cancer receiving NGS testing. RESULTS: Among 6,475 publications identified, 31 evaluated PFS and OS among subgroups of patients who received NGS-informed cancer management. PFS and OS were significantly longer among patients who were matched to targeted treatment in 11 and 16 publications across tumor types, respectively. CONCLUSION: Our review indicates that NGS-informed treatment can have an impact on survival across tumor types.

Using a Modified Delphi Panel to Estimate Health Service Utilization for Patients with Advanced and Non-Advanced Systemic Light Chain Amyloidosis.

Purpose: Patients with diagnosed with systemic light chain (AL) amyloidosis at advanced Mayo stages have greater morbidity and mortality than those diagnosed at non-advanced stages. Estimating service use by severity is difficult because Mayo stage is not available in many secondary databases. We used an expert panel to estimate healthcare utilization among advanced and non-advanced AL amyloidosis patients. Patients and Methods: Using the RAND/UCLA modified Delphi method, expert panelists completed 180 healthcare utilization estimates, consisting of inpatient and outpatient visits, testing, chemotherapy, and procedures by disease severity and organ involvement during two treatment phases (the 1 year after starting first line [1L] therapy and 1 year following treatment [post-1L]). Estimates were also provided for post-1L by hematologic treatment response (complete or very good partial response [CR/VGPR], partial, no response or relapse [PR/NR/R]). Areas of disagreement were discussed during a meeting, after which ratings were completed a second time. Results: During 1L therapy, 55% of advanced patients had ≥1 hospitalization and 38% had ≥2 admissions. Rates of hematopoietic stem cell transplant (HSCT) in advanced patients were 5%, while pacemaker or implantable cardioverter defibrillator (ICD) placement were 15%. During post-1L therapy, rates of hospitalization in advanced patients remained high (≥1 hospitalization: 20-43%, ≥2 hospitalizations: 10-20%), and up to 10% of advanced patients had a HSCT. Ten percent of these patients underwent pacemaker/ICD placement. Conclusion: Experts estimated advanced patients, who would not be good candidates for HSCT, would have high rates of hospitalization (traditionally the most expensive type of healthcare utilization) and other health service use. The development of new treatment options that can facilitate organ recovery and improve function may lead to decreased utilization.

An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19.

The RAND/UCLA modified Delphi panel method is a formal group consensus process that systematically and quantitatively combines expert opinion and evidence by asking panelists to rate, discuss, then re-rate items. The method has been used to develop medical society guidelines, other clinical practice guidelines, disease classification systems, research agendas, and quality improvement interventions. Traditionally, a group of experts meet in person to discuss results of a first-round survey. After the meeting, experts complete a second-round survey used to develop areas of consensus. During the COVID-19 pandemic, this aspect of the method was not possible. As such, we have adapted the method to conduct virtual RAND/UCLA modified Delphi panels. In this study, we present a targeted literature review to describe and summarize the existing evidence on the RAND/UCLA modified Delphi panel method and outline our adaptation for conducting these panels virtually. Transitioning from in-person to virtual meetings was not without challenges, but there have also been unexpected advantages. The method we describe here can be a cost-effective and efficient alternative for researchers and clinicians.

The Economic and Humanistic Burden of Pediatric-Onset Multiple Sclerosis.

Background: Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system. Pediatric-onset MS (POMS), defined as onset of MS before 18 years of age, is estimated to account for 2% to 5% of the MS population worldwide. Objectives: To conduct a literature review focused on the healthcare resource utilization and cost as well as quality-of-life (QOL) outcomes among patients with POMS. Methods: We conducted a systematic literature review of English-language studies published after September 2010 in MEDLINE and Embase to describe the global economic healthcare resource utilization and costs and humanistic (QOL) burden in patients with POMS. Results: We found 11 studies that reported on healthcare resource utilization, cost, or insurance coverage and 36 studies that reported on QOL outcomes in patients with POMS. Patients with POMS had higher rates of primary care visits (1.41 [1.29-1.54]), hospital visits (10.74 [8.95-12.90]), and admissions (rate ratio, 4.27 [2.92-6.25];OR, 15.2 [12.0-19.1]) compared with healthy controls. Mean per-patient costs in the United States were $5907 across all settings per year of follow-up between 2002 and 2012; mean costs per hospital stay were $38 543 (in 2015 USD) between 2004 and 2013. Three studies reported psychosocial scores between 71.59 and 79.7, and 8 studies reported physical health scores between 74.62 to 82.75 using the Pediatric Quality of Life Measurement Model (PedsQLTM). Twelve studies used the PedsQL™ Multidimensional Fatigue Scale. Mean scores on the self-reported general fatigue scale ranged from 63.15 to 78.5. Quality-of-life scores were lower than those of healthy controls. Discussion: Our review presents a uniquely broad and recent overview of the global economic and humanistic burden of patients with POMS. Additional research on healthcare resource utilization and cost would provide a more robust understanding of the economic burden in this population. Conclusions: Healthcare resource utilization and costs are high in this population, and patients report reduced QOL and significant fatigue compared with healthy children and adolescents.

Impact of early detection on cancer curability: A modified Delphi panel study.

Expert consensus on the potential benefits of early cancer detection does not exist for most cancer types. We convened 10 practicing oncologists using a RAND/UCLA modified Delphi panel to evaluate which of 20 solid tumors, representing >40 American Joint Committee on Cancer (AJCC)-identified cancer types and 80% of total cancer incidence, would receive potential clinical benefits from early detection. Pre-meeting, experts estimated how long cancers take to progress and rated the current curability and benefit (improvement in curability) of an annual hypothetical multi-cancer screening blood test. Post-meeting, experts rerated all questions. Cancers had varying estimates of the potential benefit of early cancer detection depending on estimates of their curability and progression by stage. Cancers rated as progressing quickly and being curable in earlier stages (stomach, esophagus, lung, urothelial tract, melanoma, ovary, sarcoma, bladder, cervix, breast, colon/rectum, kidney, uterus, anus, head and neck) were estimated to be most likely to benefit from a hypothetical screening blood test. Cancer types rated as progressing quickly but having comparatively lower cure rates in earlier stages (liver/intrahepatic bile duct, gallbladder, pancreas) were estimated to have medium likelihood of benefit from a hypothetical screening blood test. Cancer types rated as progressing more slowly and having higher curability regardless of stage (prostate, thyroid) were estimated to have limited likelihood of benefit from a hypothetical screening blood test. The panel concluded most solid tumors have a likelihood of benefit from early detection. Even among difficult-to-treat cancers (e.g., pancreas, liver/intrahepatic bile duct, gallbladder), early-stage detection was believed to be beneficial. Based on the panel consensus, broad coverage of cancers by screening blood tests would deliver the greatest potential benefits to patients.

Using breast cancer quality indicators in a vulnerable population.

BACKGROUND: Adherence to quality indicators may be especially important to disease-specific outcomes for uninsured, vulnerable patients. The objective of this study was to measure adherence to National Initiative for Cancer Care Quality (NICCQ) breast cancer quality indicators in a public hospital and compare performance to published rates in a previously collected 5-city cohort. METHODS: One hundred five consecutive, newly diagnosed, stage I-III, breast cancer patients at a public hospital (from 2005 to 2007) were identified. Adherence rates to 31 quality indicators were measured by using medical record abstraction. Rates were calculated for individual indicators, aggregated domains, and components of care and were compared with the 5-city cohort results by using a 2-sided test of proportions. RESULTS: Overall adherence to the NICCQ indicators at the public hospital was 82%, versus 86% in the 5-city cohort. Public hospital adherence was better in 3 domains and components (Management of Treatment Toxicity 95% vs 73%, Referrals 76% vs 15%, and Documentation of Key Clinical Factors 72% vs 64%, P < .05 for all), but it was lower in others (Testing 82% vs 96%, Adjuvant Therapy 76% vs 83%, Surgery 72% vs 86%, Surveillance 63% vs 94%, and Respect for Patient Preferences 52% vs 72%, P < .001 for all). CONCLUSIONS: The results showed that it is possible to deliver breast cancer care to vulnerable patients comparable in quality to the care received by the broader population. Further study should identify the factors that lead to variation in adherence across domains of quality.

HIV screening in commercially insured patients screened or diagnosed with sexually transmitted diseases or blood-borne pathogens.

BACKGROUND: The Centers for Disease Control strongly recommends HIV screening for all patients who present to health care settings with sexually transmitted diseases (STD) or blood-borne pathogens exposure. The objective of this study is to assess the rates and determinants of HIV screening in a national sample of commercially insured patients screened or diagnosed with an STD or hepatitis B or C. METHODS: We used Poisson regression model with a robust error variance to assess the determinants of HIV screening using administrative claims data from health plans across 6 states (n = 270,423). RESULTS: The overall HIV screening rate of patients who were diagnosed or screened for STDs or hepatitis was low (32.7%); rates were lowest for patients presenting with epididymitis or granuloma inguinale (<10%). Patients aged 25 to 34 years were more likely to be screened than other age groups. Females were significantly less likely to be screened for HIV (prevalence ratio = 0.90; 95% CI = 0.89, 0.91) than males. Patients living in states where no written HIV informed consent was required were significantly more likely to be screened than those living in states where written HIV informed consent was specifically required. CONCLUSIONS: HIV screening rates were low and varied by STD categories. Females and younger and older patients were at increased risk of no HIV screening. Requiring specific written informed consent for HIV screening resulted in less HIV screening. Interventions are urgently needed to increase the HIV screening rate among this at-risk population.

Persistence with Early-Line Abatacept versus Tumor Necrosis Factor-Inhibitors for Rheumatoid Arthritis Complicated by Poor Prognostic Factors.

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling and destruction that leads to severe disability. There are no clear guidelines regarding the order of therapies. Gathering data on treatment patterns outside of a clinical trial setting can provide useful context for clinicians. Objectives: To assess real-world treatment persistence in early-line abatacept versus tumor necrosis factor-inhibitors (TNFi) treated patients with RA complicated by poor prognostic factors (including anti-cyclic citrullinated peptide antibodies [ACPA] and rheumatoid factor [RF] seropositivity). Methods: We performed a multi-center retrospective medical record review. Adult patients with RA complicated by poor prognostic factors were treated with either abatacept or TNFis as the first biologic treatment at the clinic. Poor prognostic factors included ACPA+, RF+, increased C-reactive protein levels, elevated erythrocyte sedimentation rate levels, or presence of joint erosions. We report 12-month treatment persistence, time to discontinuation, reasons for discontinuation, and risk of discontinuation between patients on abatacept versus TNFi. Select results among the subgroup of ACPA+ and/or RF+ patients are presented. Results: Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi patients (P=0.003). Median time to discontinuation was 1423 days for abatacept versus 690 days for TNFis (P=0.014). In adjusted analyses, abatacept patients had a lower risk of discontinuing index treatment due to disease progression (0.3 [95% confidence interval (CI): 0.1-0.6], P=0.001). Among the subgroup of ACPA+ and/or RF+ patients (55 abatacept, 108 TNFis), unadjusted 12-month treatment persistence was greater (83.6% versus 64.8%, P=0.012) and median time to discontinuation was longer (961 days versus 581 days, P=0.048) in abatacept versus TNFi patients. Discussion: Patients with RA complicated by poor prognostic factors taking abatacept, including the subgroup of patients with ACPA and RF seropositivity, had statistically significantly higher 12-month treatment persistence and a longer time to discontinuation than patients on TNFis. Conclusions: In a real-world setting, RA patients treated with abatacept were more likely to stay on treatment longer and had a lower risk of discontinuation than patients treated with TNFis.

Developing an emergency department order set to treat acute pain in sickle cell disease.

STUDY OBJECTIVE: Patients with sickle cell disease (SCD) have many emergency department visits because of painful vaso-occlusive episodes (VOE). Guidelines recommend treatment within 30 minutes of triage, but this is rarely achieved in clinical practice. Our goal was to develop an order set that is being implemented in the ED to facilitate and standardize emergency care for SCD patients in acute pain from VOEs presenting to the emergency department (ED) in New York City (NYC). METHODS: Using a RAND/University of California, Los Angeles modified Delphi panel, we convened a multidisciplinary panel and reviewed evidence on how to best manage SCD pain in the ED. Panelists collaboratively developed then rated 202 items that could be included in an ED order set. RESULTS: A consensus order set, a practical how-to guide for managing SCD pain in the ED, was developed based on items that received high median ratings. CONCLUSIONS: The management of acute pain experienced during VOEs is critical to patients with SCD; ED order sets, such as this one, can help standardize pain management, including at triage, evaluation, discharge, and follow-up care. After implementation in NYC EDs, studies to examine changes in quality care metrics (eg, wait times, readmissions) are planned.

Tapering thrombopoietin receptor agonists in primary immune thrombocytopenia: Expert consensus based on the RAND/UCLA modified Delphi panel method.

BACKGROUND: Thrombopoietin receptor agonists (TPO-RAs) are used to treat primary immune thrombocytopenia (ITP). Some patients have discontinued treatment while maintaining a hemostatic platelet count. OBJECTIVES: To develop expert consensus on when it is appropriate to consider tapering TPO-RAs in ITP, how to taper patients off therapy, how to monitor patients after discontinuation, and how to restart therapy. METHODS: We used a RAND/UCLA modified Delphi panel method. Ratings were completed independently by each expert before and after a meeting. Second-round ratings were used to develop the panel's guidance. The panel was double-blinded: The sponsor and nonchair experts did not know each other's identities. RESULTS: Guidance on when it is appropriate to taper TPO-RAs in children and adults was developed based on patient platelet count, history of bleeding, intensification of treatment, trauma risk, and use of anticoagulants/platelet inhibitors. For example, it is appropriate to taper TPO-RAs in patients who have normal/above-normal platelet counts, have no history of major bleeding, and have not required an intensification of treatment in the past 6 months; it is inappropriate to taper TPO-RAs in patients with low platelet counts. Duration of ITP, months on TPO-RA, or timing of platelet response to TPO-RA did not have an impact on the panel's guidance on appropriateness to taper. Guidance on how to taper patients off therapy, how to monitor patients after discontinuation, and how to restart therapy is also provided. CONCLUSION: This guidance could support clinical decision making and the development of clinical trials that prospectively test the safety of tapering TPO-RAs.

Improving breast cancer quality of care with the use of patient navigators.

The continuum of breast cancer care requires multidisciplinary efforts. Patient navigators, who perform outreach, coordination, and education, have been shown to improve some areas of care. However, little research has assessed the impact of navigators on breast cancer treatment in uninsured populations. Our objective is to report on the impact of a patient navigator program on breast cancer quality of care at a public hospital. One hundred consecutive newly diagnosed patients with breast cancer (Stages I to III) were identified (2005 to 2007). Forty-nine patients were treated before the use of navigators and 51 after program implementation. Nine breast cancer quality indicators were used to evaluate quality of care. Overall adherence to the quality indicators improved from 69 to 86 per cent with the use of patient navigators (P < 0.01). Only one individual indicator, use of surveillance mammography, improved significantly (52 to 76%, P < 0.05). All nine indicators reached 75 per cent or greater adherence rates after implementation of the navigator program compared with only four before implementation. Patient navigators appear to improve breast cancer quality of care in a public hospital. In populations in which cultural, linguistic, and financial barriers are prevalent, navigator programs can be effective in narrowing the observed gaps in the quality of cancer care.

Behavioral factors associated with successful weight loss after gastric bypass.

Patients undergoing bariatric surgery lose substantial weight (> or = 50% excess weight loss [EWL]), but an estimated 20 per cent fail to achieve this goal. Our objective was to identify behavioral predictors of weight loss after laparoscopic Roux-en-Y gastric bypass. We retrospectively surveyed 148 patients using validated instruments for factors predictive of weight loss. Success was defined as > or =50 per cent EWL and failure as <50 per cent EWL. Mean follow-up after laparoscopic Roux-en-Y gastric bypass was 40.1 +/- 15.3 months, with 52.7 per cent of patients achieving successful weight loss. After controlling for age, gender, and preoperative body mass index, predictors of successful weight loss included surgeon follow-up (odds ratio [OR] 8.2, P < 0.01), attendance of postoperative support groups (OR 3.7, P = 0.02), physical activity (OR 3.5, P < 0.01), single or divorced marital status (OR 3.2, P = 0.03), self-esteem (OR 0.3, P = 0.02), and binge eating (OR 0.9, P < 0.01). These factors should be addressed in prospective studies of weight loss after bariatric surgery, as they may identify patients at risk for weight loss failure who may benefit from early tailored interventions.

The Humanistic and Economic Burden of Pediatric Focal Seizures in the United States.

OBJECTIVE: To better understand the humanistic and economic burden of focal seizures in children 2-12 years old. METHODS: We conducted a targeted literature review by searching MEDLINE for English-language publications reporting on children 2-12 years old with focal seizures published in the United States since 2008. RESULTS: Thirty-five publications were included. Incidence of focal seizures was 23.2 to 47.1 per 100,000 children per year; prevalence was 2.0 per 1,000 children, and ranged from 1.6 - 2.6 per 1,000 in patients of any age. Life expectancy was 47.3-61.8 years among children 3-12 years old. Patients took several antiepileptic drugs and experienced frequent seizures, sleep disorders, mood disorders, migraine, and seizure-related injuries (eg, bone fractures, sprains, open wounds). Children with focal seizures scored below average on cognitive assessments and up to 42%, 16%, and 19% had depression, anxiety, and attention-deficit disorder, respectively. Patients of any age had about 10 outpatient visits (2 epilepsy-related), 2 inpatient visits (less than 1 epilepsy-related), and 24 procedures (1 epilepsy-related) per year. Medication adherence was low: only half of pediatric patients maintained ≥90% adherence over 6 months. Annual total health care costs among patients of any age ranged from $18,369 - 38,549; first-year total health care costs for children were $19,883. CONCLUSIONS: Incidence and prevalence of focal seizures is high and the humanistic and economic burdens are significant. Future studies focused exclusively on children with focal seizures are needed to more precisely describe the burden. We also suggest further research and implementation of methods to improve medication adherence as an approach to lessen burden on these young patients.

Development of a Severity Classification System for Sickle Cell Disease.

PURPOSE: There is no well-accepted classification system of overall sickle cell disease (SCD) severity. We sought to develop a system that could be tested as a clinical outcome predictor. PATIENTS AND METHODS: Using validated methodology (RAND/UCLA modified Delphi panel), 10 multi-disciplinary expert clinicians collaboratively developed 180 simplified patient histories and rated each on multiple axes (estimated clinician follow-up frequency, risk of complications or death, quality of life, overall disease severity). Using ratings on overall disease severity, we developed a 3-level severity classification system ranging from Class I (least severe) to Class III (most severe). RESULTS: The system defines patients as Class I who are 8-40 years with no end organ damage, no chronic pain, and ≤4 unscheduled acute care visits due to vaso-occlusive crises (VOC) in the last year. Patients <8 or >40 years with no end organ damage, no chronic pain, and <2 unscheduled acute care visits are also considered Class I. Patients any age with ≥5 unscheduled acute care visits and/or with severe damage to bone, retina, heart, lung, kidney, or brain are classified as Class III (except patients ≥25 years with severe retinopathy, no chronic pain, and 0-1 unscheduled acute care visits, who are considered Class II). Patients not meeting these Class I or III definitions are classified as Class II. CONCLUSION: This system consolidates patient characteristics into homogenous groups with respect to disease state to support clinical decision-making. The system is consistent with existing literature that increased unscheduled acute care visits and organ damage translate into clinically significant patient morbidity. Studies to further validate this system are planned.

Readmissions following pancreaticoduodenectomy for pancreas cancer: a population-based appraisal.

Procedure complexity and volume-outcome relationships have led to increased regionalization of pancreaticoduodenectomy (PD) for pancreas cancer. Knowledge regarding outcomes after PD comes from single-institutional series, which may be limited if a significant number of patients follow up at other hospitals. Thus, readmission data may be underreported. This study utilizes a population-based data set to examine readmission data following PD. California Cancer Registry (1994-2003) was linked to the California's Office of Statewide Health Planning and Development (OSHPD) database; patients with pancreatic adenocarcinoma who had undergone PD, excluding perioperative (30-day) mortality, were identified. All hospital readmissions within 1 year following PD were analyzed with respect to timing, location, and reason for readmission. Our cohort included 2,023 patients who underwent PD for pancreas cancer. Fifty-nine percent were readmitted within 1 year following PD and 47% were readmitted to a secondary hospital. Readmission was associated with worse median survival compared with those not readmitted (10.5 versus 22 months, p<0.0001). Multivariate analysis revealed that increasing T-stage, age, and comorbidities were associated with increased likelihood of readmission. Diagnoses associated with high rates of readmission included progression of disease (24%), surgery-related complications (14%), and infection (13%). Diabetes (1.4%) and pain (1.5%) were associated with low rates of readmission. We found a readmission rate of 59%, which is much higher than previously reported by single institutional series. Concordantly, nearly half of patients readmitted were readmitted to a secondary hospital. Common reasons for readmission included progression of disease, surgical complications, and infection. These findings should assist in both anticipating and facilitating postoperative care as well as managing patient expectations. This study utilizes a novel population-based database to evaluate incidence, timing, location, and reasons for readmission within 1 year following pancreaticoduodenectomy. Fifty-nine percent of patients were readmitted within 1 year after pancreaticoduodenectomy and 47% were readmitted to a secondary hospital.

Are 12 nodes needed to accurately stage T1 and T2 colon cancers?

Evaluation of 12 lymph nodes has been mandated to prevent colon cancer understaging. Given that the probability of node metastases is largely associated with T-stage, are <12 nodes substandard for T1 and T2 lesions? We evaluated if survival for T1 and T2 tumors varies by nodes examined. In SEER, 61,237 patients undergoing colon cancer resection were identified. For each T-stage, 5-year survival rates were compared for node-negative cancers by using stepwise node cut-point comparisons (4 nodes, <4, etc.). Survival impact was determined by log-rank test and hazard regression. For T1 tumors, 4 nodes had 24% lower hazard of death compared to <4. For T2 tumors, 10 nodes had the biggest survival impact, 15% lower hazard of death. In conclusion, the number of nodes to stage T1 and T2 lesions may be <12.