Implications of therapy interruption on monthly migraine days and modified migraine disability assessment in patients treated with erenumab for chronic and episodic migraine: SQUARE study interim results.

BACKGROUND: There are limited real-world data in Switzerland examining the impact of erenumab, a fully human IgG2 monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, on migraine-related quality of life. OBJECTIVE: This 18-month interim analysis of 172 patients with episodic or chronic migraine from the SQUARE study provides first prospective insights on the impact of mandatory erenumab treatment interruption, following Swiss-reimbursement requirements, in a real-world clinical setting in Switzerland. FINDINGS: Recruited patients receiving 70 or 140 mg erenumab underwent treatment interruption on average 11.2 months after therapy onset with a mean duration of 4 months. There were sustained improvements in mean monthly migraine days (MMD) and migraine disability (mMIDAS) during initial treatment with erenumab. Treatment interruption was associated with a temporary worsening of condition. Symptoms ameliorated upon therapy reuptake reaching improvements similar to pre-break within 3 months. CONCLUSIONS: Treatment interruption was associated with a temporary worsening of condition, which improved again after therapy restart.

Expert endoscopist assessment of colorectal polyp size using virtual scale endoscopy, visual or snare-based estimation: a prospective video-based study.

BACKGROUND AND AIMS: Accurate polyp size estimation during colonoscopy has an impact on clinical decision-making. A laser-based virtual scale endoscope (VSE) is available to allow measuring polyp size using a virtual adaptive scale. This study evaluates video-based polyp size measurement accuracy among expert endoscopists using either VSE or visual assessment (VA) with either snare as reference size or without any reference size information. METHODS: A prospective, video-based study was conducted with 10 expert endoscopists. Video sequences from 90 polyps with known reference size (fresh specimen measured using calipers) were distributed on three different slide sets so that each slide set showed the same polyp only once with either VSE, VA or snare-based information. A slide set was randomly assigned to each endoscopist. Endoscopists were asked to provide size estimation based on video review. RESULTS: Relative accuracies for VSE, VA, and snare-based estimation were 75.1% (95% CI [71.6-78.5]), 65.0% (95% CI [59.5-70.4]) and 62.0% (95% CI [54.8-69.0]), respectively. VSE yielded significantly higher relative accuracy compared to VA (p = 0.002) and to snare (p = 0.001). A significantly lower percentage of polyps 1-5 mm were misclassified as >5 mm using VSE versus VA and snare (6.52% vs. 19.6% and 17.5%, p = 0.004) and a significantly lower percentage of polyps >5 mm were misclassified as 1-5 mm using VSE versus VA and snare (11.4% vs. 31.9% and 14.9%, p = 0.038). CONCLUSIONS: Endoscopists estimate polyp size with the highest accuracy when virtual adaptive scale information is displayed. Using a snare to assist sizing did not improve measurement accuracy compared to displaying visual information alone.

Development and initial validation of a video-based peroral endoscopic myotomy assessment tool.

BACKGROUND AND AIMS: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM). METHODS: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability. RESULTS: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure." CONCLUSIONS: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool.

Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results.

BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018-02,375 in the Register of All Projects in Switzerland (RAPS).

[CME/Answers: New-Onset Headache in Adults: Evidence-Based Assessment in the Primary Care Setting]. / CME/Antworten: Neuartige Kopfschmerzen bei Erwachsenen: evidenzbasiertes Vorgehen für die Praxis.

CME/Answers: New-Onset Headache in Adults: Evidence-Based Assessment in the Primary Care Setting Abstract. Many people suffer from headaches. Primary (idiopathic) headaches such as migraine and tension type headaches are most common. They may significantly affect occupational and social aspects of daily life, but are usually not dangerous. On the contrary, secondary (symptomatic) headaches may be a symptom for an underlying life-threatening disorder. In these cases, the primary care physician may need to organize certain diagnostic measures such as brain imaging, blood work or lumbar puncture. Sometimes, emergency hospital admission may be required. In this article we summarize the recommended steps for the assessment of new-onset headaches in patients visiting the primary care practice.

[New-Onset Headache in Adults: Evidence-Based Assessment in the Primary Care Setting]. / CME: Neuartige Kopfschmerzen bei Erwachsenen: evidenzbasiertes Vorgehen für die Praxis.

New-Onset Headache in Adults: Evidence-Based Assessment in the Primary Care Setting Abstract. Many people suffer from headaches. Primary (idiopathic) headaches such as migraine and tension type headaches are most common. They may significantly affect occupational and social aspects of daily life, but are usually not dangerous. On the contrary, secondary (symptomatic) headaches may be a symptom for an underlying life-threatening disorder. In these cases, the primary care physician may need to organize certain diagnostic measures such as brain imaging, blood work or lumbar puncture. Sometimes, emergency hospital admission may be required. In this article we summarize the recommended steps for the assessment of new-onset headaches in patients visiting the primary care practice.

Time lost due to an attack - a novel patient-reported outcome measure for acute migraine treatments.

OBJECTIVE: We propose a new outcome measure to assess the efficacy of migraine treatments translating the approach of the Global Burden of Disease studies from a societal to an individual level: Instead of calculating "years lived with disability", we suggest estimating "time lost due to an attack". METHODS: Time lost due to an attack is calculated by multiplying the duration and the degree of impaired functioning during an attack. RESULTS: Time lost due to an attack, different from other outcome measures, does not just focus on the short-term analgesic effects of treatments, but rather on the improvement of all migraine symptoms and restoration of functioning, also considering therapy-related impairment. Importantly, time lost due to an attack measures the entire time patients are not functioning normally, from onset to complete resolution. CONCLUSIONS: Time lost due to an attack represents a new paradigm to assess migraine burden in single patients for a patient-centered evaluation of both acute and prophylactic treatments.

The Cost of Clipping-How Much Does Price Matter?

ABSTRACT: Clip closure is effective for large (≥ 20 mm) nonpedunculated polyps in the proximal colon. The cost-effectiveness analysis by Albeniz et al. found that selective clipping of polyps at a minimum risk (>13% in the United States, >10% in Spain) is worthwhile clipping. Although such model is theoretically sound, clinical practice should be primarily guided by efficacy data. Moreover, the analysis is very sensitive to the high price of clips, which is likely to reduce in the foreseeable future.

ESGE and ESGENA Position Statement on gastrointestinal endoscopy and the COVID-19 pandemic.

We are currently living in the throes of the COVID-19 pandemic that imposes a significant stress on health care providers and facilities. Europe is severely affected with an exponential increase in incident infections and deaths. The clinical manifestations of COVID-19 can be subtle, encompassing a broad spectrum from asymptomatic mild disease to severe respiratory illness. Health care professionals in endoscopy units are at increased risk of infection from COVID-19. Infection prevention and control has been shown to be dramatically effective in assuring the safety of both health care professionals and patients. The European Society of Gastrointestinal Endoscopy (www.esge.com) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (www.esgena.org) are joining forces to provide guidance during this pandemic to help assure the highest level of endoscopy care and protection against COVID-19 for both patients and endoscopy unit personnel. This guidance is based upon the best available evidence regarding assessment of risk during the current status of the pandemic and a consensus on which procedures to perform and the priorities on resumption. We appreciate the gaps in knowledge and evidence, especially on the proper strategy(ies) for the resumption of normal endoscopy practice during the upcoming phases and end of the pandemic and therefore a list of potential research questions is presented. New evidence may result in an updated statement.

Valuing innovative endoscopic techniques: prophylactic clip closure after endoscopic resection of large colon polyps.

BACKGROUND AND AIMS: Clip closure of the mucosal defect after resecting large (≥20 mm) nonpedunculated colorectal polyps reduces postprocedure bleeding and is cost saving for payers. Clip costs are not reimbursed by payers, posing a major barrier to adoption of this technique in the community. We aimed to determine appropriate clip costs to support broader use of this procedure in practice. METHODS: We performed budget impact analysis using our recent decision analytic model, comparing prophylactic clip closure with no clip closure on national cost and outcomes data, to determine the maximum feasible clip price while maintaining cost savings in practice. Sensitivity analyses were performed on important clinical factors. RESULTS: In the original model, the baseline postprocedure bleeding risk was 6.8%, increasing cost of care by $614.11 averaged among all patients undergoing large polyp resection without clip closure. Prophylactic clip closure of only large right-sided polyps reduced postprocedure bleeding risk by 70.7% but resulted in cost saving only if the price of clips was $100 or less. Comparatively, prophylactic clip closure of large left-sided polyps had no clinical benefit and was not cost saving. Clip closure strategies focused only on extra-large polyps (≥40 mm), or patients taking antithrombotics regardless of polyp characteristics, were only minimally cost saving. Cost savings and maximum tolerated clip prices depended on medical comorbidity, which directly influences the costs of care to manage postprocedure bleeding. CONCLUSIONS: Prophylactic clip closure after endoscopic resection of large colon polyps, particularly those in the right colon segment, is cost saving but requires clip costs less than $100. Translating these findings into practice requires gastroenterology practices to obtain reimbursement from payers for improved clinical outcomes and to align commercial clip prices with this clinical indication.

Interictal Burden of Cluster Headache: Results of the EUROLIGHT Cluster Headache Project, an Internet-Based, Cross-Sectional Study of People With Cluster Headache.

OBJECTIVE: The aim of this study was to measure the interictal burden (IIB) associated with cluster headache (CH). BACKGROUND: CH is characterized by an alternation of excruciatingly painful attacks and pain-free periods. Absence of pain does not necessarily imply absence of symptoms, though. Some may persist or improve more slowly than pain; others may arise in between attacks. METHODS: Participants filled out an online survey based on the EUROLIGHT questionnaire. Inclusion criteria were a reported diagnosis of CH and residency in a European country; exclusion criteria were refusal to give informed consent and to complete the questionnaire. RESULTS: Most of the burden was related to higher headache frequencies: ongoing symptoms despite pain freedom, impaired autonomy due to avoidance of triggers, reluctance to tell others about the disease, and the feeling of not being understood by family and friends, employers and colleagues. Irreversible, potentially accumulating burden may occur if headache frequency is high; examples are impairment of career options, relationships, and family planning issues. Worrying about future attacks and avoiding potential triggers occur independently from attack frequency and disease duration. There were no differences between the in-bout and the out-bout period among participants with episodic CH. Participants with chronic CH reported greater IIB. CONCLUSIONS: Even between attacks CH can have a huge and potentially irreversible impact on life. Different types of IIB were identified, all of which may contribute to the total burden of disease. As cumulative burden might be irreversible, prevention strategies need to be developed.

Development and validation of a video-based cold snare polypectomy assessment tool (with videos).

BACKGROUND AND AIMS: Polyps <1 cm are the most commonly found polyps during colonoscopy. Cold snare removal is preferred given the significantly higher rate of incomplete resection associated with piecemeal biopsy forceps resection. There are currently no standardized tools to assess competence in cold snare polypectomy. This study aimed to develop and validate a cold snare polypectomy assessment tool (CSPAT). METHODS: Experts in cold snare polypectomy used a Delphi method to develop the CSPAT. Metrics with a greater than 85% agreement as being "important" or "very important" were included in the CSPAT. The tool included evaluation of polyp inspection, positioning, appropriate ensnarement of tissue to ensure a rim of normal tissue, tissue retrieval, and postpolypectomy site inspection. Experts in cold snare polypectomy used the CSPAT to evaluate preselected videos that were previously evaluated using the Direct Observation of Polypectomy Skills (DOPyS) tool. Interobserver agreement was evaluated. CSPAT scores were compared with DOPyS scores to assess content validity. RESULTS: Sixteen experts developed the 12-item CSPAT, and 13 experts reviewed 55 videos. There was a moderate degree of agreement in 10 metrics (κ = .52-.59) and a substantial degree of agreement (κ = .61-.63) in the other 2. There was a strong correlation between the mean of individual metrics 1 to 12 compared with the global competence assessment (ρ = .88, P < .001). There was a moderate correlation between the average overall DOPyS score and the overall CSPAT competence score (ρ = .56, P < .001). CONCLUSIONS: We have developed and validated a customized CSPAT that can be easily applied to video-based assessments to assess competence in training and among practicing endoscopists.

Simplifying Resect and Discard Strategies for Real-Time Assessment of Diminutive Colorectal Polyps.

BACKGROUND & AIMS: During endoscopy, the resect and discard strategy, if performed with high confidence, can be used to determine histologic features of diminutive colorectal polyps (5 mm or less). These polyps can then be removed and discarded without pathology assessment. However, the complexities of real-time optical assessment and follow-up management have provided challenges to widespread use of this approach. We aimed to determine the outcomes of simple alternative strategies, in which all diminutive polyps can be resected and discarded. METHODS: We collected data from 2 previous studies that used narrow-band imaging to assess polyps, performed at 5 medical centers (1658 patients with 2285 diminutive polyps; 15 endoscopists). We compared 3 resect and discard strategies: the currently used optical strategy, which relies on high confidence optical assessment of all diminutive polyps; a location-based strategy that classifies all recto-sigmoid diminutive polyps a priori as hyperplastic and all polyps proximal to the recto-sigmoid colon a priori as neoplastic; and a simplified optical strategy, in which all recto-sigmoid diminutive polyps are classified as hyperplastic unless confidently assessed as neoplastic, and all polyps proximal to the recto-sigmoid colon are classified as neoplastic unless confidently assessed as hyperplastic polyps. The primary outcome was the agreement of the surveillance interval calculated for each strategy with the surveillance interval determined by pathology analysis. RESULTS: The proportion of surveillance intervals that agreed with pathology-based surveillance recommendations was slightly higher when the optical strategy was used compared to the location-based strategy or simplified optical strategy (94% vs 89% and 90%, respectively; P < .001). When the 5-10 year recommendations for patients with low-risk polyps were applied as a 10-year surveillance interval, all 3 strategies resulted in surveillance interval agreement compared to pathology above 90% (the quality benchmark). Use of the simplified or location-based strategy could have avoided pathology analysis for 77% of all polyps, compared to 59% if the optical strategy was used (P < .001). In addition, a higher proportion of patients could receive recommendations immediately after colonoscopy with use of the simplified or location based strategy (65%) compared to the optical strategy (40%) (P < .001). CONCLUSION: A location-based and a simplified optical resect and discard strategy produced surveillance recommendations that were in agreement with those from pathology analysis for at least 90% of patients, assuming a 10-year surveillance interval for patients with low-risk polyps. These strategies could further reduce the number of pathology examinations and provide more patients with immediate surveillance recommendations. Optical assessment might be reduced or might not be required for resect and discard. Clintrials.gov no: NCT01935180 and NCT01288833.

Colonoscopy practice for veterans within and outside the Veterans Affairs setting: a matched cohort study.

BACKGROUND AND AIMS: To minimize delays for colonoscopy within Veterans Affairs (VA) facilities, veterans may receive care at non-VA facilities based on fee-for-service contracts, and more recently, through the Veterans Access, Choice, and Accountability Act. The impact of diverting care from VA to non-VA facilities on quality of colonoscopy practice is unknown. METHODS: We identified all veterans aged 50 to 85 years who received a fee-basis colonoscopy for colorectal cancer screening or surveillance at non-VA facilities in 2007 to 2010. These patients were matched for sex, age, and year of procedure to veterans who underwent colonoscopies at VA medical centers. The outcomes of interest were the adenoma detection rates (ADR) and compliance with surveillance guidelines. RESULTS: During the observation period, 409 veterans (mean age 64 years; 94% men) underwent a fee-basis colonoscopy at 30 nonacademic (54%) and 2 academic (46%) facilities. Compared with colonoscopies performed at VA facilities, fee-basis colonoscopy patients had lower ADRs (38% vs 52%; P < .001), lower mean number of adenomas per procedure (0.72 vs 1.41; P < .001), and lower number of advanced ADRs (13% vs 22%; P < .001). Colonoscopies done at non-VA facilities were associated with lower ADRs in multivariate regression analysis (odds ratio 0.64; 95% CI, 0.44-0.92), whereas colonoscopies done in nonacademic settings or by colonoscopists who were not gastroenterologists were not. Compliance with surveillance guidelines was lower for colonoscopies performed outside VA facilities (80% vs 87%; P = .03). CONCLUSIONS: In this regional study (Northern New England), compliance with colonoscopy surveillance guidelines was high in both VA and non-VA settings; however, lower ADRs raise concern that referring veterans outside the VA system may impact colonoscopy quality.

Repeated upper endoscopy in the Medicare population: a retrospective analysis.

BACKGROUND: Esophagogastroduodenoscopy (EGD) is done often for various indications. Little is known about the frequency of repeated EGD and the diagnoses that drive it. OBJECTIVE: To describe the frequency of repeated EGD in the Medicare population and determine diagnoses most often associated with it. DESIGN: Retrospective analysis. SETTING: Medicare database. PATIENTS: Among a 5% random sample of Medicare beneficiaries, Current Procedural Terminology (CPT) codes were used to identify patients who had an index EGD between 2004 and 2006. Diagnoses from the International Classification of Diseases, Ninth Revision, Clinical Modification, reported for the index endoscopy were divided into 3 diagnostic groups on the basis of whether the index diagnosis suggested that repeated EGD was expected, uncertain, or not expected. MEASUREMENTS: Proportion of patients with repeated EGD within 3 years of an index EGD. RESULTS: Approximately 12% of Medicare beneficiaries had an EGD between 2004 and 2006 (n = 108 785). Of these, 33% (n = 36 331) had at least 1 repeated EGD within 3 years. Of all patients with initial EGDs, 10% (n = 11 370) had an associated diagnosis suggesting a need for follow-up examination, whereas 61% (n = 66 307) did not. Of all patients with repeated examinations, 54% (n = 19 687) came from the group in which repeated EGD was not expected. When new clinical events were excluded, 43% of all patients with repeated EGDs (n = 15 706) did not have a diagnosis at index or repeated EGD that justified a repeated examination. LIMITATION: Whether individual procedures were clinically indicated cannot be verified. CONCLUSION: One in 3 Medicare beneficiaries who received an EGD had a repeated EGD within 3 years. Nearly one half of repeated examinations were done in patients with diagnoses at index or repeated EGD that did not suggest the need for a repeated examination. PRIMARY FUNDING SOURCE: None.

Lower endoscopy reduces colorectal cancer incidence in older individuals.

BACKGROUND & AIMS: In older individuals, there are unclear effects of lower endoscopy on incidence of colorectal cancer (CRC) and of colonoscopy on site of CRC. We investigated whether sigmoidoscopy or colonoscopy is associated with a decreased incidence of CRC in older individuals, and whether the effect of colonoscopy differs by anatomic location. METHODS: We performed a case-control study using linked US Veterans Affairs and Medicare data. Cases were veterans aged 75 years or older diagnosed with CRC in fiscal year 2007. Cases were matched for age and sex to 3 individuals without a CRC diagnosis (controls). We determined the number of cases and controls who received colonoscopies or sigmoidoscopies from fiscal year 1997 to a date 6 months before the diagnosis of CRC (for cases) or to a corresponding index date (for controls). The probability of exposure was modeled using generalized linear mixed equations, adjusted for potential confounders. For the analysis of CRC risk in different anatomic locations, the proximal colon was defined as proximal to the splenic flexure. RESULTS: We identified 623 cases and 1869 controls (mean age, 81 y; 98.7% male, 86.2% Caucasian). Among cases, 243 (39.0%) underwent any lower endoscopy (177 colonoscopies). Among controls, 978 (52.3%) underwent any lower endoscopy (758 colonoscopies). Cases were significantly less likely than controls to have undergone lower endoscopy within the preceding 10 years (adjusted odds ratio [aOR], 0.58; 95% confidence interval [CI], 0.48-0.69). This effect was significant for colonoscopy (aOR, 0.57; 95% CI, 0.47-0.70), but not sigmoidoscopy. Similar results were observed when a 5-year exposure window was applied. Colonoscopy was associated with a reduced risk of distal CRC (aOR, 0.45; 95% CI, 0.32-0.62) and proximal CRC (aOR, 0.65; 95% CI, 0.46-0.92). CONCLUSIONS: In a study of the US Veterans Affairs and Medicare databases, lower endoscopy in the preceding 10 years was associated with a significant reduction in CRC incidence among older veterans. Colonoscopy was associated with significant reductions in distal and proximal CRC.

The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps.

The PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative is an ASGE program whose objectives are to identify important clinical questions related to endoscopy and to establish a priori diagnostic and/or therapeutic thresholds for endoscopic technologies designed to resolve these clinical questions. Additionally, PIVIs may also outline the data and or the research study design required for proving an established threshold is met. Once endoscopic technologies meet an established PIVI threshold, those technologies are appropriate to incorporate into clinical practice presuming the appropriate training in that endoscopic technology has been achieved. The ASGE encourages and supports the appropriate use of technologies that meet its established PIVI thresholds. The PIVI initiative was developed primarily to direct endoscopic technology development toward resolving important clinical issues in endoscopy. The PIVI initiative is also designed to minimize the possibility that potentially valuable innovations are prematurely abandoned due to lack of utilization and to avoid widespread use of an endoscopic technology before clinical studies documenting their effectiveness have been performed. The following document, or PIVI, is one of a series of statements defining the diagnostic or therapeutic threshold that must be met for a technique or device to become considered appropriate for incorporation into clinical practice. It is also meant to serve as a guide for researchers or those seeking to develop technologies that are designed to improve digestive health outcomes. An ad hoc committee under the auspices of the existing ASGE Technology and Standards of Practice Committees Chairs develops PIVIs. An expert in the subject area chairs the PIVI, with additional committee members chosen for their individual expertise. In preparing this document, evidence-based methodology was employed, using a MEDLINE and PubMed literature search to identify pertinent clinical studies on the topic. PIVIs are ultimately submitted to the ASGE Governing Board for approval, as is done for all Technology and Standards of Practice documents. This document is provided solely for educational and informational purposes and to support incorporating these endoscopic technologies into clinical practice. It should not be construed as establishing a legal standard of care.

Endoscopic versus surgical therapy for early cancer in Barrett's esophagus: a decision analysis.

BACKGROUND: Esophagectomy for early esophageal adenocarcinoma is associated with increased operative mortality and morbidity, but possibly a decreased recurrence rate compared with endoscopic therapy when using EMR and radiofrequency ablation. OBJECTIVE: To compare the cost-effectiveness of esophagectomy and endoscopic therapy in the treatment of early esophageal adenocarcinoma. DESIGN: Decision analysis model. MAIN OUTCOME MEASUREMENTS: Incremental cost-effectiveness ratio. RESULTS: During the 5-year study period, endoscopic therapy cost $17,000.00 and yielded 4.88 quality-adjusted life years, compared with $28,000.00 and 4.59, respectively, for esophagectomy. Varying the recurrence rates of cancer or Barrett's esophagus metaplasia after endoscopic therapy did not change the overall outcome. The sensitivity analysis demonstrated, however, that the outcome depended on the rate of lymph node involvement and operative mortality. Under the best of circumstances in favor of esophagectomy, such as 2% operative mortality, no reduced quality of life after esophagectomy, and a low 5-year survival rate after recurrence of endoscopic ablation, the risk of positive lymph nodes still needed to exceed 25% before esophagectomy became the preferred treatment option. This threshold is twice as high as the values reported for early submucosal cancer invasion. LIMITATIONS: Limited data are available about the long-term outcome of EMR and radiofrequency ablation. CONCLUSIONS: Endoscopic therapy for early Barrett's esophagus adenocarcinoma is more effective and less expensive than esophagectomy. Even in early esophageal adenocarcinoma with submucosal invasion, endoscopic therapy is a cost-effective alternative to esophagectomy, especially in patients with a high operative risk.