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Objective Recent American College of Rheumatology guidelines emphasise functional improvement as part of osteoarthritis (OA) management. We developed and evaluated a tool to promote provider and patient engagement in functional goal setting in OA care. Methods We developed the Functional Goal-setting And Self-management Tool (FAST-OA) with clinician input and pilot tested it in two US outpatient clinics. Baseline and end-of-project surveys addressed attitudes toward incorporating function into care and tool evaluation. We analysed survey data descriptively. Results Nineteen providers and 49 patients completed surveys. At baseline, both groups endorsed the importance of functional assessment and goal setting. Providers perceived challenges to patients' ability to communicate about function. Both patients and providers highly valued the FAST-OA to promote collaborative discussion and prioritising function. More than half of both groups agreed that they would recommend it to others. End-of-project results suggested changes in provider attitudes toward patients' ability to communicate functional progress. While participants valued the FAST-OA, streamlining content may foster ongoing use. Conclusion This pilot study illustrates the potential of a function-focused, patient-facing tool to introduce self-management goal-setting strategies into busy clinical workflow, foster the provider-patient relationship, and encourage alignment with guidelines. These results can inform tailoring of tools for use in practice and to address needs of patients and providers optimally.

Minimally invasive methods have been described to detect Barrett’s esophagus (BE), but are limited by subjectivity and suboptimal accuracy. We identified methylated DNA markers (MDMs) for BE in tissue and assessed their accuracy on whole esophagus brushings and capsule sponge samples. Step 1: Unbiased whole methylome sequencing was performed on DNA from BE and normal squamous esophagus (SE) tissue. Discriminant MDM candidates were validated on an independent patient cohort (62 BE cases, 30 controls) by quantitative methylation specific PCR (qMSP). Step 2: Selected MDMs were further evaluated on whole esophageal brushings (49 BE cases, 36 controls). 35 previously sequenced esophageal adenocarcinoma (EAC) MDMs were also evaluated. Step 3: 20 BE cases and 20 controls were randomized to swallow capsules sponges (25 mm, 10 pores or 20 pores per inch (ppi)) followed endoscopy. DNA yield, tolerability, and mucosal injury were compared. Best MDM assays were performed on this cohort. Step 1: 19 MDMs with areas under the ROC curve (AUCs) >0.85 were carried forward. Step 2: On whole esophageal brushings, 80% of individual MDM candidates showed high accuracy for BE (AUCs 0.84–0.94). Step 3: The capsule sponge was swallowed and withdrawn in 98% of subjects. Tolerability was superior with the 10 ppi sponge with minimal mucosal injury and abundant DNA yield. A 2-marker panel (VAV3 + ZNF682) yielded excellent BE discrimination (AUC = 1). Identified MDMs discriminate BE with high accuracy. BE detection appears safe and feasible with a capsule sponge. Corroboration in larger studies is warranted. ClinicalTrials.gov number NCT02560623.

Background: Studies of colorectal cancer screening by multitarget stool DNA (MT-sDNA) show false-positive (FP) rates of 7% to 13%. It is unclear whether FP patients are at increased long-term risk of adverse outcomes. Methods: We compared subsequent clinical events among patients with apparent FP MT-sDNA with those in patients reported as true negative (TN). This was a retrospective cohort study of participants in pre-FDA approval MT-sDNA studies having nonadvanced or negative baseline colonoscopy findings from a single referral center. Per-protocol and calibrated cutoffs defined FP and TN groups. From the time of stool collection, we measured differences between FP and TN groups in time to death, subsequent cancer diagnosis, and onset of alarm symptoms. Results: Of 1,050 eligible patients, only 6 were lost to follow-up. Median age was 65.6 years [interquartile range (IQR), 56.8–72.3]; 54% were female. Median follow-up time was 4 years (IQR, 3.5–5.3). Eight aerodigestive (lung and gastrointestinal tract) cancers occurred. FP status by calibrated, but not per-protocol, cutoffs was associated with subsequent aerodigestive cancer; however, cumulative incidence did not exceed SEER expectations from the general population. By any cutoff method, FP status was not associated with mortality or alarm symptoms. Conclusions: Although FP status was associated with long-term aerodigestive cancers, new cases were not temporally related and did not exceed incidence estimates from general population. Impact: These observations do not justify aggressive follow-up evaluation for patients with FP MT-sDNA at this time. Larger studies are needed to confirm these early findings. Cancer Epidemiol Biomarkers Prev; 26(4); 614–21. ©2016 AACR.

Introduction: Many health systems lack internal smoking cessation programs despite the need to personalize smoking cessation support for patients. Though smoking cessation services are important, systems often lack needed resources to create programs from scratch. Mount Sinai Hospital System implemented a smoking cessation program by cross training CDEs as smoking cessation health coaches since they were embedded across the network and experts in health behavior change. Methods: The entire CDE team was trained via WebEx lectures and through shadowing a tobacco treatment specialist pulmonologist in her practice. Patient and HCP engagement materials were developed as well as EHR enablement and policies/procedures to support the new program. The initial, target population was smokers with upcoming surgery since they were a discrete population and likely motivated to quit smoking to improve surgical outcomes. CDEs created personalized smoking cessation plans with patients and obtained medications through collaborative discussions with the patients’ primary care physician. Results: Eight CDEs participated. The CDEs report increased job satisfaction by operating at the top of their licenses and learning a new therapeutic area. Patient and provider feedback has been strongly positive, and the program is expanding. Conclusion: CDEs may serve as an internal resource to expand smoking cessation services within a health system. Disclosure A. Schwartz: None. L.R. DePalo: None. J.K. Simonson: Employee; Self; Pfizer Inc. E. Weinberger: None. M.E. Rodriguez: None. D.L. Rosenberg: None. J. Kartashevsky: None. Funding Pfizer Inc.

Stool DNA testing represents a potential noninvasive approach to detect upper gastrointestinal (UGI) neoplasms. However, little is known about fecal recovery efficiency of DNA exfoliated from UGI tumors. The purpose of this study was to establish a human ingestion model that quantitatively approximates daily cellular shedding from UGI neoplasms and to estimate fecal DNA marker recovery rates. Healthy volunteers (n = 10) ingested two scheduled doses of raw salmon, 0.3 and 30 g, simulating the mass exfoliated daily from 1 to 4.5 cm lesions. To approach a steady-state, each dose was ingested over three consecutive days in randomized order. Following defecation of an indicator dye ingested with test meals, stools were collected over 48 h. Ingested salmon DNA was captured from stools using probes targeting pathognomonic Salmonidae sequences (SlmII). Captured DNA was quantified using PCR primers to generate 178, 138, 88 and 55 bp amplicons. SlmII sequences were recovered from all stools following salmon ingestion; recovery was proportional to amount ingested (p = 0.004). Fecal recovery of ingested salmon varied inversely with amplicon size targeted; mean recovery rates of SlmII were 0.49, 0.91, 3.63, and 7.31 copies per 100,000 copies ingested for 178, 134, 88, and 55 bp amplicons, respectively (p

Fecal occult blood testing (FOBT) has historically relied on methods to detect hemoglobin with no fundamental innovations in decades. To examine microRNA (miRNA) as a new marker class for FOBT. Candidate miRNA markers were identified by small RNA sequencing of human whole blood compared to colorectal epithelia. Markers were tested in human blood cell subsets and blood from non-human species. We assessed assay linearity in blood spiking and marker stability in stool over incubation experiments. Levels of candidate erythrocyte markers were explored in stools from colorectal cancer (CRC) cases and controls. Based on small RNA sequencing and validation RT-qPCR, expression level of each of the top blood-enriched markers (hsa-miR-144-3p, 144-5p, 451a, 486-5p, 363-3p, 20b-5p) could perfectly discriminate blood from colorectal epithelia. All six markers arose from and showed specificity to human erythrocytes. Marker levels increased linearly with erythrocyte concentration in saline or stool and demonstrated a broader dynamic range than did immunochemical test for hemoglobin. Degradation of markers occurred in stool but was reduced with preservative buffers. Erythrocyte marker candidates for stool testing were selected in an exploratory set of stools (20 CRC, 40 normal). Candidates were then further tested in a feasibility set (29 CRC, 31 advanced adenoma, and 115 normal); a miRNA panel (hsa-miR-451a, 144-5p, and 200b-3p as normalizer) yielded an AUC of 0.89 (95% CI 0.82–0.95, P

Purpose The purpose of this study is to examine the impact of a Care Management Organization (CMO) Diabetes Disease Management Program (DDMP) in improving diabetes outcomes among high-risk patients with type 2 diabetes (T2DM) in the Bronx, New York. Methods An interventional, nonrandomized study design was used to assess the effectiveness of the DDMP. Patients older than 18 years who had T2DM and an A1C persistently 8% or greater or with a cardiovascular comorbidity were characterized as high risk and received intensive disease management. Patients served as their own controls, with data collection and analysis occurring 12 months prior to and 12 months after enrollment in DDMP. Data collection included screening rates for A1C, low-density lipoprotein (LDL) cholesterol, depression, smoking status, and annual influenza vaccine administration. Changes in A1C and LDL cholesterol were also analyzed. Statistical analyses were conducted using Minitab. McNemar’s chi-square and paired t tests were used to assess within-group changes from baseline to final outcomes. Results Significant improvements in screening rates for A1C, LDL, depression, smoking status, and annual influenza vaccine administration were found among high-risk/intensively managed patients in the DDMP. Improvements in clinical measures were also achieved in this group. Provider and patient satisfaction surveys were positive, with 92% of patients believing that the program helped them better understand their disease. Conclusions A DDMP among high-risk patients has shown promise in improving the quality of care for patients with diabetes. This program has relevance for other integrated delivery systems that are developing accountable care approaches.

Upper abdominal pain (UAP) in patients with gallstones is often treated by cholecystectomy but it frequently persists. We aimed to identify symptoms associated with relief.We followed 1008 patients who received cholecystectomy for gallstones and UAP at the Mayo Clinic (Rochester, Minnesota) or Kaiser Permanente (San Diego, California) for 12 months. A validated, self-completed biliary symptoms questionnaire identified features of UAP, gastroesophageal reflux disease (GERD), and irritable bowel syndrome (IBS); the questionnaire was given initially and 3 and 12 months after cholecystectomy, to identify features that predicted sustained relief of UAP.Five hundred ninety-four patients (59%) reported relief from UAP. Factors associated univariately (P.05) with relief included frequency of UAP ≤1 per month, onset ≤1 year preoperatively, usual duration (30 minutes to 24 hours, most often in the evening or night), and severity5/10. Compared to no features, multiple predictive features of UAP (frequency, onset, duration, or timing) were associated with increasing odds ratios (95% confidence interval) for relief: 1, 2, or 3 features (4.2 [1.1-16]; P = .03) and 4 features (6.3 [1.6-25]; P = .008). Negative univariate associations included lower abdominal pain (LAP), usual bowel pattern, nausea ≥1 per week, often feeling bloated or burpy, GERD, and/or IBS. There was an inverse association between relief and somatization; relief was not associated with postprandial UAP. Multivariable logistic regression analysis revealed independent associations (P.05) with UAP frequency, onset, and nocturnal awakening, but inverse associations with lower abdominal pain, abnormal bowel pattern, and frequent bloated or burpy feelings.UAP features and concomitant GERD, IBS, and somatization determine the odds for relief from UAP after cholecystectomy.

Eosinophilic esophagitis (EE) is a clinicopathologic syndrome comprising isolated eosinophilic inflammation of the esophagus, with symptoms of dysphagia, and possibly, reflux. It was initially described in children, and in recent years, there is a heightened awareness in adults. The etiology is not completely understood. The treatments include dietary manipulation, topical corticosteroids, systemic corticosteroids, Montelukast, and endoscopic dilation. In adults, there are no randomized trials demonstrating the efficacy of any particular treatment, and no prospective studies describing the natural history of the disease following treatment.We performed an interval follow-up of patients treated with a swallowed corticosteroid inhaler. We contacted 51 adult patients who were diagnosed with EE and treated with a swallowed corticosteroid inhaler between September 1, 1999, and May 31, 2003. All patients had received 6 wk of treatment with fluticasone 220 mEq/puff, four puffs swallowed twice daily for 6 wk.Thirty-two patients replied (63%) with a mean follow-up duration of 3.3 yr. Ninety-one percent of patients reported recurrent symptoms; a mean of 8.8 months after treatment was completed. Sixty-nine percent of patients repeated treatment with the steroid inhaler at least once.It appears that EE is a chronic remitting disorder that requires more than one topical steroid treatment course.

Background & Aims: In experimental animal models of irritable bowel syndrome (IBS) and human studies, peripheral κ opioid agonists have been shown to decrease sensation to colonic distention. The aim of this study was to compare the effects of the κ opioid agonist, asimadoline, and placebo on episodes of abdominal pain in patients with IBS. Methods: After a 2-week run-in period, 100 patients with IBS were randomized (3:2 ratio) to receive asimadoline, up to 1 mg 4 times daily, or placebo for 4 weeks in a double-blind study. Pain was scored by daily diary using a 100-mm visual analogue scale. During pain episodes, patients recorded the pain severity, took study medication, and recorded their pain score 2 hours later. The primary end point was the average reduction in pain severity 2 hours after treatment. Results: The average pain reduction 2 hours posttreatment was not significantly different between the groups. Post hoc analyses suggest asimadoline was effective in mixed IBS (P = .003, unadjusted), but may be worse in diarrhea-predominant IBS (P = .065 unadjusted). The anxiety score was reduced modestly by asimadoline (P = .053). No significant adverse effects were noted. Conclusions: An on-demand dosing schedule of asimadoline was not effective in reducing severity of abdominal pain in IBS. Further studies in visceral pain and IBS appear warranted.

341 Background: Precursors to 1/3 of colorectal cancer (CRC), serrated polyps have historically been underdetected by screening due to their inconspicuous, nonhemorrhagic, and proximal nature. New generation sDNA-MT show high sensitivity for both CRC and advanced adenomas (Gastroenterology 2012;142:248), but screen detection of serrated polyps by this approach requires further validation. Aim: To assess and compare noninvasive detection of sessile serrated polyps >1cm (SSP) by sDNA-MT and a commercial quantitative FIT. Methods: In a blinded prospective study, a single stool sample used for both tests was collected from 456 asymptomatic adults prior to screening or surveillance colonoscopy (criterion standard). All 29 patients with SSP were included as cases and all 232 with no neoplastic findings as controls. Buffered stool samples were processed and frozen on receipt; Exact Sciences performed sDNA-MT in batches using optimized analytical methods (Gastroenterology 2012;142:S770). The sDNA-MT panel targets methylated BMP3 (mBMP3) and NDRG4, mutant KRAS, β-actin, and hemoglobin. FIT (Polymedco OC-FIT Check) was performed in separate lab 65 years and 51% vs 59% women, p=NS respectively. SSP median size was 1.2cm (range 1-3cm), 93% were proximal, and 64% had synchronous diminutive polyps. Among sDNA-MT markers, mBMP3 proved highly discriminant for SSP detection (AUC=0.87, p

We have demonstrated that colorectal cancer (CRC) and advanced pre-cancers can be detected non-invasively by a manual multi-target stool DNA-based test (sDNA-MT) comprising exfoliated DNA markers (methylated BMP3 and NDRG4, mutant KRAS (7 mutations, codons 12, 13), plus β-actin) and fecal hemoglobin (Hb) (Lidgard, Gastroenterology 2012;142(5);S-770). We now report the clinical performance of this sDNA-MT test using an optimized automated analytic platform and logistic algorithm. This platform could facilitate the routine performance of sDNA-MT for CRC screening by molecular diagnostics capable clinical laboratories. Method: Stool samples were collected from 1003 subjects at 36 study sites after informed consent and prior to colonoscopy bowel preparation from those presenting for average risk CRC screening (283) or surveillance (176) at 2 sites. From referred subjects with CRC, Advanced Adenoma (AA) or Sessile Serrate Adenoma ≥ 1 cm, (SSA) stool was collected at least 7 days post-colonoscopy and prior to surgery or chemo-radiation (135; 21 sites) and similarly for subjects with no neoplastic findings on colonoscopy (Neg) (409; 13 sites). The study population included: cases (207), 58% male, median age 65 yrs. (38-87), CRC (93), AA (84), SSA ≥ 1 cm (30) and controls (796), 42% male, median age 65 yrs. (50-84), Neg (641) and non-advanced adenomas (NA) (155). Stool sample collection and DNA isolation were previously described. Automated methylation, mutation and actin assays were performed with a Hamilton STARlet fluid handler (Hamilton Robotics, Reno NV), and QuARTS (Quantitative Allele-specific Real-time Target and Signal amplification) run on an ABI 7500 FastDx real time thermal cycler (Applied Biosystems, Foster City, CA). Fecal Hb (ng/ml buffer) analysis was performed by automated sandwich ELISA. A “Positive” or “Negative” result was determined with an algorithm that included the methylation and mutation results and a logistic regression score, which combines DNA marker results with Hb and actin results. Algorithm results exceeding a threshold were called “Positive”. The algorithm provided good discriminative ability, stability, sensitivity and specificity. Robustness was tested with computer simulations and statistical techniques (leave-one-out and 10-fold cross validation). Results: At a 90% nominal specificity, sDNA-MT sensitivity was 98% for CRC (91/93) [Stage: I, 95% (20/21), II, 100% (23/23), III 96% (26/27), IV 100% (7/7) and I-III combined 97% (69/71)], 57% (65/114) for precursors ≥1 cm (AA, SSA), and 86% (12/14) for precursors with high grade dysplasia. CRC patients were typically referred to colonoscopy for symptoms and test sensitivity may be elevated relative to that seen with screening. Conclusion: With this study using a novel automated sDNA-MT analytic platform with logistic algorithm, we corroborate our earlier findings using a manual process and demonstrate a platform that allows testing to be performed routinely by molecular diagnostic capable laboratories. The high sensitivity of sDNA-MT for CRC across all stages and for advanced precursors with high-grade dysplasia could lead to improved non-invasive CRC screening performance with wide accessibility to patients. A large multi-site pivotal CRC screening study (DeeP-C study clinicaltrials.gov, NCT01397747) to support such use is underway. Citation Format: Graham P. Lidgard, Michael J. Domanico, Janelle J. Bruinsma, James Light, Zubin D. Gagrat, Rebecca L. Oldham-Haltom, Keith D. Fourrier, Hatim Allawi, Tracy C. Yab, Julie A. Simonson, Mary Devens, Russell I. Heigh, David A. Ahlquist, Barry M. Berger. An optimized molecular stool test for colorectal cancer screening: Evaluation of an automated analytic platform and logistic algorithm. [abstract]. In: Proceedings of the Eleventh Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2012 Oct 16-19; Anaheim, CA. Philadelphia (PA): AACR; Cancer Prev Res 2012;5(11 Suppl):Abstract nr B12.

Background: Organized colorectal cancer screening program in the Czech Republic (10.5 million inhabitants, 3.8 million aged over 50) was introduced in year 2000, based on guaiac fecal occult blood test (FOBT). In 2009, new program design was launched. To asymptomatic individuals aged 50 54, annual guaiac or immunochemical FOBT has been offered, followed by screening colonoscopy, if positive. In age of 55, there is a choice of either FOBT biannually or primary screening colonoscopy in 10 years interval. Methods: Early performance indicators (European guidelines 2010) were used to assess the efficacy of the program Results: The coverage of target population has been rising since the program introduction, reaching 23% in 2010. The overall FOBT positivity of 6.1% has been recorded. Since the beginning of on-line individual data management in year 2006, until November 2011, there were 59,320 screening colonoscopies (FOBT+) and 8,493 primary screening colonoscopies performed (basic result included in the table). A trend for earlier stage cancer detection was observed (42.7% in stage I). Average ADR and CIR were 31.2% and 94.2% respectively. In years 2006 2010, there were reported 45 cases of perforations (0.08% of all colonoscopies). Conclusion: The Czech national Colorectal Cancer Screening program is growing in performance and influential. Introduction of the new program design increases the target population coverage. Main findings on (primary) screening colonoscopies

Noninvasive Detection of Colorectal Neoplasia (CRN) in Inflammatory Bowel Disease (IBD) by Stool DNA Testing: A Pilot Study John B. Kisiel, Tracy C. Yab, Fareeda Taher Nazer Hussain, William R. Taylor, Jonathan J. Harrington, Mary E. Devens, Julie A. Simonson, Megan Garrity-Park, William J. Sandborn, Edward V. Loftus, Bruce G. Wolff, David T. Rubin, Steven H. Itzkowitz, Hongzhi Zou, David A. Ahlquist

Non-apoptotic human DNA (long DNA) in stool is a discriminant marker for colorectal cancer (Gastroenterology 2000; 119:1219). Fecal long DNA may originate from either the exfoliation of dysplastic cells or from the luminal hemorrhage or exudation of leukocytes. The contribution of these potential sources long DNA in stool has not been examined. If leukocytes are the major source, then fecal human DNA and occult blood levels should correlate. If exfoliation is the major source, then fecal human DNA and occult blood should be complementary markers for colorectal cancer. AIM: To quantify and correlate human DNA and hemoglobin in stools from patients with colorectal neoplasia, and to consider a simple stool assay for cancer screening. METHODS: Subjects comprised 74 patients with colorectal cancer, 27 with adenomas >1cm, and 100 with normal colonoscopy. One stool per subject was collected in stabilization buffer before or > 1 week after colonoscopy. Fecal long DNA and occult blood were quantified in blinded fashion by real-time Alu PCR (CEBP 2006 15:1115) and the HemoQuant assay (Mayo Medical Laboratories), respectively. HemoQuant assay results are not affected by fecal storage (Ann Intern Med 1984;101:297) and could be reliably applied to archival specimens for this study. RESULTS: Fecal long DNA and occult blood showed no correlation (R2=0). At 90% specificities, long DNA testing detected 70% of colorectal cancers and 46% of adenomas while occult blood testing detected 50% and 12%, respectively. Combining these tests detected 80% colorectal cancers and 46% of adenomas at 90% specificity. For detection of colorectal cancer, AUC values were 0.82, 0.78, and 0.90 for fecal long DNA, occult blood, and combination testing, respectively (p

Non-apoptotic human DNA (long DNA) in stool is a discriminant marker for colorectal cancer (Gastroenterology 2000; 119:1219). Fecal long DNA may originate from either the exfoliation of dysplastic cells or from the luminal hemorrhage or exudation of leukocytes. The contribution of these potential sources long DNA in stool has not been examined. If leukocytes are the major source, then fecal human DNA and occult blood levels should correlate. If exfoliation is the major source, then fecal human DNA and occult blood should be complementary markers for colorectal cancer. AIM: To quantify and correlate human DNA and hemoglobin in stools from patients with colorectal neoplasia, and to consider a simple stool assay for cancer screening. METHODS: Subjects comprised 74 patients with colorectal cancer, 27 with adenomas >1cm, and 100 with normal colonoscopy. One stool per subject was collected in stabilization buffer before or > 1 week after colonoscopy. Fecal long DNA and occult blood were quantified in blinded fashion by real-time Alu PCR (CEBP 2006 15:1115) and the HemoQuant assay (Mayo Medical Laboratories), respectively. HemoQuant assay results are not affected by fecal storage (Ann Intern Med 1984;101:297) and could be reliably applied to archival specimens for this study. RESULTS: Fecal long DNA and occult blood showed no correlation (R2=0). At 90% specificities, long DNA testing detected 70% of colorectal cancers and 46% of adenomas while occult blood testing detected 50% and 12%, respectively. Combining these tests detected 80% colorectal cancers and 46% of adenomas at 90% specificity. For detection of colorectal cancer, AUC values were 0.82, 0.78, and 0.90 for fecal long DNA, occult blood, and combination testing, respectively (p

Non-apoptotic human DNA (long DNA) in stool is a discriminant marker for colorectal cancer (Gastroenterology 2000; 119:1219). Fecal long DNA may originate from either the exfoliation of dysplastic cells or from the luminal hemorrhage or exudation of leukocytes. The contribution of these potential sources long DNA in stool has not been examined. If leukocytes are the major source, then fecal human DNA and occult blood levels should correlate. If exfoliation is the major source, then fecal human DNA and occult blood should be complementary markers for colorectal cancer. AIM: To quantify and correlate human DNA and hemoglobin in stools from patients with colorectal neoplasia, and to consider a simple stool assay for cancer screening. METHODS: Subjects comprised 74 patients with colorectal cancer, 27 with adenomas >1cm, and 100 with normal colonoscopy. One stool per subject was collected in stabilization buffer before or > 1 week after colonoscopy. Fecal long DNA and occult blood were quantified in blinded fashion by real-time Alu PCR (CEBP 2006 15:1115) and the HemoQuant assay (Mayo Medical Laboratories), respectively. HemoQuant assay results are not affected by fecal storage (Ann Intern Med 1984;101:297) and could be reliably applied to archival specimens for this study. RESULTS: Fecal long DNA and occult blood showed no correlation (R2=0). At 90% specificities, long DNA testing detected 70% of colorectal cancers and 46% of adenomas while occult blood testing detected 50% and 12%, respectively. Combining these tests detected 80% colorectal cancers and 46% of adenomas at 90% specificity. For detection of colorectal cancer, AUC values were 0.82, 0.78, and 0.90 for fecal long DNA, occult blood, and combination testing, respectively (p

Background & Aims: The aim of this study was to validate a [13C]–Spirulina platensis gastric emptying (GE) breath test (GEBT) with a standardized meal. Methods: Thirty-eight healthy volunteers and 129 patients with clinically suspected delayed GE underwent measurements at 45, 90, 120, 150, 180, and 240 minutes after a 238 kcal meal labeled test with 100 mg [13C]–S platensis and 0.5 mCi 99mTc. We established normal ranges for scintigraphy with this test meal, intraindividual and interindividual coefficients of variation (COVs), and the ability of the [13C] GEBT breath percent dose excreted *1000 values to predict scintigraphic half-life and to categorize GE as delayed, normal, or accelerated. Results: In health, the 10th and 90th percentiles of half-life for scintigraphic GE with this meal were 52 and 86 minutes; intraindividual COVs for scintigraphy and the GEBT were, respectively, 31% and 27% at 45 minutes, 17% and 21% at 90 minutes, 13% and 16% at 120 minutes, 10% and 13% at 150 minutes, and 8% and 12% at 180 minutes. Interindividual COVs at each time for the [13C] GEBT and scintigraphy were typically ∼1%–4% lower than intraindividual COVs. Individual breath samples at 45, 150, and 180 minutes predicted GE category; at 80% specificity, 45- and 180-minute samples combined were 93% sensitive to identify accelerated GE, and 150- and 180-minute combined were 89% sensitive for delayed GE. Conclusions: [13C]–S platensis GEBT is as reproducible as scintigraphy; imprecision with both tests reflects physiologic variation. With 4 breath samples, this method with an off-the-shelf meal is valid to assess GE in clinic and in research.