ABSTRACT
BACKGROUND: The performance of bowel preparation (BP) in patients with Crohn's disease (CD) is unknown. AIMS: To evaluate the operating properties of instruments used to assess BP quality in patients with CD. METHODS: We used the Boston Bowel Preparation Scale, modified Boston Bowel Preparation Scale, Harefield Cleansing Scale, Food and Drug Administration Bowel Cleansing Assessment Scale (BCAS), and a 100-mm visual analogue scale of bowel cleanliness to assess BP quality in 50 videos from 40 patients with CD. We assessed endoscopic activity with the Simple Endoscopic Score for CD (SES-CD). Assessments were on endoscope insertion and withdrawal. Reliability was quantified using the intraclass correlation coefficient (ICC). We assessed validity by within-patient correlation between instruments and the visual analogue scale using mixed-effect models. The correlation between BP quality and SES-SD scores was assessed using Spearman's rho. RESULTS: Inter- and intra-rater reliability for all BP quality instruments was substantial (ICC ≥0.61) except for the Food and Drug Administration BCAS on insertion (inter-rater reliability ICC ≥0.41). The visual analogue scale had substantial inter- and almost perfect (ICC ≥0.81) intra-rater reliability. Correlation coefficients for the validity of the instruments exceeded 0.58. BP quality and endoscopic disease activity scores in the colon were negatively correlated. CONCLUSION: Most existing instruments reliably assess BP quality in patients with CD. These results support the use of these instruments in clinical practice, provide a framework for scoring BP quality in CD clinical trials, and support evaluation of novel BP agents in patients with CD.
ABSTRACT
Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States. Management of disseminated metastatic CRC involves various active drugs, either in combination or as single agents. The choice of therapy is based on consideration of the goals of therapy, the type and timing of prior therapy, the mutational profile of the tumor, and the differing toxicity profiles of the constituent drugs. This manuscript summarizes the data supporting the systemic therapy options recommended for metastatic CRC in the NCCN Guidelines for Colon Cancer.
Subject(s)
Colonic Neoplasms , Humans , Colonic Neoplasms/diagnosis , Colonic Neoplasms/therapy , Colonic Neoplasms/pathology , Colonic Neoplasms/drug therapy , Medical Oncology/standards , Medical Oncology/methods , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , United StatesABSTRACT
CONTEXT.: Quality measures that are supported by evidence-based clinical practice guidelines are preferred for assessing the quality of pathologists' practices. Careful testing of a measure ensures that scores obtained by that measure reflect the quality of a pathologist's practice. OBJECTIVE.: To specify a new quality measure and to demonstrate through testing that it is suitable for measuring pathologists' appropriate incorporation of information regarding microsatellite instability (MSI) and/or mismatch repair (MMR) status in pathology reports for colorectal, endometrial, gastroesophageal, and small bowel carcinoma. DESIGN.: The College of American Pathologists collaborated with the American Gastroenterological Association to specify and test the new measure. Face validity testing was used to investigate the validity of the measure. Feasibility testing was conducted to understand if data elements required by the measure specification were readily accessible. Signal-to-noise analysis was used to characterize the measure's reliability. RESULTS.: Guideline recommendations for MSI and/or MMR testing supported specifications for the measure. Face validity testing indicated that the measure could distinguish the quality of care provided. Data elements required by the measure specification were found to be accessible, which supported the measure's feasibility. Reliability testing showed that differences in measure score were attributable to real differences in performance rather than random variation in scoring. CONCLUSIONS.: The Mismatch Repair or Microsatellite Instability Biomarker Testing Status in Colorectal Carcinoma, Endometrial, Gastroesophageal, or Small Bowel Carcinoma measure was appropriately specified, and testing demonstrated that it is well suited for characterizing the quality of pathologists' communication of MMR and/or MSI status.
ABSTRACT
Epstein-Barr virus (EBV) is acquired early in life as asymptomatic or symptomatic infectious mononucleosis (IM) and remains latent in a few B cells in most individuals. Pathologic EBV-reactivation affects immunosuppressed individuals and manifests as IM-like syndromes, polyclonal lymphoproliferative disorders, EBV-related lymphomas, and carcinomas. EBV-associated gastritis is an underrecognized and very rarely reported entity. We report a case of a 65-year-old woman with ruxolitinib-treated polycythemia vera, who developed EBV viremia and EBV gastritis. The patient improved after the ruxolitinib dose reduction and administration of antiviral therapy. A few months after discontinuation of the antiviral therapy the gastric symptoms recurred, numerous gastric ulcers were identified, and a nasopharyngeal mass was detected. A biopsy of the nasopharynx showed an EBV (+) diffuse large B cell lymphoma. Ruxolitinib was discontinued and the patient was started on rituximab monotherapy with a resolution of symptoms and pathologic improvement. Our case supports earlier reports of an association of ruxolitinib therapy with EBV complications. An early diagnosis of EBV gastritis in immunocompromised patients is important since the gastric infection may precede or co-exist with a developing EBV-associated malignancy. Our case and existing literature suggest that EBV gastritis in symptomatic patients with iatrogenic immunosuppression requires discontinuation of immunosuppressive therapy if feasible, treatment with antivirals, and close surveillance for possible evolving/concurrent EBV (+) malignancy.
Subject(s)
Epstein-Barr Virus Infections , Gastritis , Lymphoma, Large B-Cell, Diffuse , Lymphoproliferative Disorders , Female , Humans , Aged , Herpesvirus 4, Human , Epstein-Barr Virus Infections/complications , Neoplasm Recurrence, Local/complications , Immunosuppression Therapy/adverse effects , Antiviral Agents , Gastritis/complicationsABSTRACT
BACKGROUND: Several online calculators estimate colorectal cancer risk, but their consistency is unknown. Our objectives were to quantify the variation in predicted risk and to determine which calculators are best used in the clinical setting. METHODS: We used the Google search engine to identify online colorectal cancer risk calculators and assessed the output of each for 3 hypothetical screening scenarios (low-, average-, and high-risk), varied by age (50, 62, 75 years), sex, and race (Black, White), with risk levels based on risk-appropriate values for variables in each model. Estimated risks for models within a given scenario were rated as consistent or inconsistent based on comparison with either the absolute magnitude of difference or average lifetime risk of colorectal cancer. Summary statistics for consistent and inconsistent estimates were compared using chi-square and Fisher's exact tests. RESULTS: We identified 5 online colorectal cancer risk calculators. Inconsistencies were found in none of 5-year, 19% of 10-year, and 81% of lifetime colorectal cancer risk estimate comparisons (P < .001). For a 50-year-old, 22% of risk estimate comparisons were inconsistent, vs 33% for a 62-year-old, and 36% for a 75-year-old (P = 0.14). CONCLUSIONS: Online colorectal cancer risk models are more consistent in predicting colorectal cancer risk for 5- and 10-year time frames compared with lifetime. For a US population, the National Cancer Institute's Colorectal Cancer Risk Assessment Tool is a rigorously developed calculator that can be used in the clinical setting to provide 5-year and lifetime risk estimates.
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Humans , Middle Aged , Aged , Risk Assessment , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/epidemiologyABSTRACT
BACKGROUND: Despite regular need for colonoscopy in patients with Crohn's disease (CD), the efficacy and tolerability of bowel preparation (BP) agents is rarely assessed in this population. Assessing BP quality with existing scales may be challenging in CD due to presence of inflammation, bowel resection, and strictures. AIMS: To provide recommendations for assessing BP quality in clinical trials for CD using a modified Research and Development/University of California, Los Angeles appropriateness process. METHODS: Based on systematic reviews and a literature search, 110 statements relating to BP quality assessment in CD were developed. A panel of 15 gastroenterologists rated the statements as appropriate, uncertain, or inappropriate using a 9-point Likert scale. RESULTS: Panelists considered it appropriate that central readers, either alone or with local assessment, score BP quality in clinical trials. Central readers should be trained on scoring BP quality and local endoscopists on performing high-quality video recording. Both endoscope insertion and withdrawal phases should be reviewed to score BP quality in each colonic segment and segments should align with endoscopic disease activity indices. The Harefield Cleansing Scale and the Boston Bowel Preparation Scale were considered appropriate. The final score should be calculated as the average of all visualized segments. Both total and worst segment scores should also be assessed. CONCLUSIONS: We developed a framework for assessing BP quality in patients with CD based on expert feedback. This framework could support the development or refinement of BP quality scales and the integration of BP quality assessment in future CD studies.
Subject(s)
Colon , Colonoscopy , Crohn Disease , Humans , Consensus , Constriction, Pathologic , Crohn Disease/diagnosis , Crohn Disease/drug therapyABSTRACT
This selection from the NCCN Guidelines for Rectal Cancer focuses on management of malignant polyps and resectable nonmetastatic rectal cancer because important updates have been made to these guidelines. These recent updates include redrawing the algorithms for stage II and III disease to reflect new data supporting the increasingly prominent role of total neoadjuvant therapy, expanded recommendations for short-course radiation therapy techniques, and new recommendations for a "watch-and-wait" nonoperative management technique for patients with cancer that shows a complete response to neoadjuvant therapy. The complete version of the NCCN Guidelines for Rectal Cancer, available online at NCCN.org, covers additional topics including risk assessment, pathology and staging, management of metastatic disease, posttreatment surveillance, treatment of recurrent disease, and survivorship.
Subject(s)
Rectal Neoplasms , Humans , Medical Oncology , Neoadjuvant Therapy , Rectal Neoplasms/diagnosis , Rectal Neoplasms/pathology , Rectal Neoplasms/therapyABSTRACT
Lynch syndrome (LS) is an autosomal dominant hereditary cancer syndrome caused by pathogenic germline variants (PGV) in any of the 4 DNA mismatch repair (MMR) genes, MLH1, MSH2, MSH6, and PMS2, or deletions in EPCAM. LS leads to an increased risk of intestinal and extraintestinal cancers, of which colorectal and endometrial cancers are the most common. Individuals at risk for LS can be identified by using clinical criteria, prediction models, and universal tumor testing. Understanding each of these tools, including limitations and mimics of LS, is essential to the early identification of at-risk individuals.
Subject(s)
Colorectal Neoplasms, Hereditary Nonpolyposis , Colorectal Neoplasms, Hereditary Nonpolyposis/diagnosis , Colorectal Neoplasms, Hereditary Nonpolyposis/genetics , DNA Mismatch Repair/genetics , Genetic Predisposition to Disease , Germ-Line Mutation , Humans , MutL Protein Homolog 1/geneticsABSTRACT
Background. In some health care systems, patients face long wait times for screening colonoscopy. We sought to assess whether patients at low risk for colorectal cancer (CRC) would be willing to delay their own colonoscopy so higher-risk peers could undergo colonoscopy sooner. Methods. We surveyed 1054 Veterans regarding their attitudes toward repeat colonoscopy and risk-based prioritization. We used multivariable regression to identify patient factors associated with willingness to delay screening for a higher-risk peer. Results. Despite a physician recommendation to stop screening, 29% of respondents reported being "not at all likely" to stop. However, 94% reported that they would be willing to delay their own colonoscopy for a higher-risk peer. Greater trust in physician and greater health literacy were positively associated with willingness to wait, while greater perceived threat of CRC and Black or Latino race/ethnicity were negatively associated with willingness to wait. Conclusion. Despite high enthusiasm for repeat screening, patients were willing to delay their own colonoscopy for higher-risk peers. Appealing to altruism could be effective when utilizing scarce resources.
Subject(s)
COVID-19/diagnosis , COVID-19/therapy , Quality Assurance, Health Care , SARS-CoV-2 , HumansABSTRACT
BACKGROUND: Inappropriate prescribing is a highly important problem, given the growing aging multimorbid population with associated polypharmacy. An increasing number of studies have recently developed and tested interventions to withdraw inappropriate drugs, a process called deprescribing. However, we still lack complete information on the types and prevalence of measures used to assess the success of such interventions. OBJECTIVE: To categorize and synthesize the full spectrum of measures used in intervention studies focused on reducing inappropriate prescribing of chronic drugs in adults, to standardize measurements in future studies and help researchers design studies inclusive of the important measure types. DESIGN: We searched Ovid/MEDLINE to identify intervention studies focused on deprescribing chronic drugs in adults, published between 2010 and 2019. MEASUREMENTS: We extracted data on study characteristics, intervention components, and outcome measures. We categorized and synthesized the measures using a comprehensive and systematic framework, separating measures of intended and unintended consequences. RESULTS: Most (90/93) studies used measures of appropriate prescribing, such as drug cessation or dose reduction. The following measures were used infrequently across studies: patient-reported experience, preferences, and outcome (12 (13%), 2 (2%), and 25 (27%) studies, respectively); provider-reported experience (11 (12%) studies); patient-provider interaction (4 (4%) studies); and measures of unintended consequences (24 (26%) studies). Studies varied in the type and number of measures assessed, ranging from 1 to 20 different measures by study. CONCLUSION: To ensure initiation, success, and long-term sustainability of deprescribing, it is important to assess the success of intervention studies using clinically relevant patient- and provider-centered measures. This categorized synthesis of outcome measures used in deprescribing studies may facilitate implementation of important measure types (e.g., patient-reported measures and measures of unintended consequences) in future studies. J Am Geriatr Soc 68:2390-2398, 2020.
Subject(s)
Deprescriptions , Inappropriate Prescribing/prevention & control , Medication Therapy Management , Aged , Aged, 80 and over , Female , Humans , Male , Outcome Assessment, Health Care , PolypharmacyABSTRACT
IMPORTANCE: Studies of interventions to reduce low-value care are increasingly common. However, little is known about how the effects of such interventions are measured. OBJECTIVE: To characterize measures used to assess interventions to reduce low-value care. EVIDENCE REVIEW: We searched PubMed and Web of Science to identify studies published between 2010 and 2016 that examined the effects of interventions to reduce low-value care. We also searched ClinicalTrials.gov to identify ongoing studies. We extracted data on characteristics of studies, interventions, and measures. We then developed a framework to classify measures into the following categories: utilization (e.g., number of tests ordered), outcome (e.g., mortality), appropriateness (e.g., overuse of antibiotics), patient-reported (e.g., satisfaction), provider-reported (e.g., satisfaction), patient-provider interaction (e.g., informed decision-making elements), value, and cost. We also determined whether each measure was designed to assess unintended consequences. FINDINGS: A total of 1805 studies were identified, of which 101 published and 16 ongoing studies were included. Of published studies (N = 101), 68% included at least one measure of utilization, 41% of an outcome, 52% of appropriateness, 36% of cost, 8% patient-reported, and 3% provider-reported. Funded studies were more likely to use patient-reported measures (17% vs 0%). Of ongoing studies (registered trials) (N = 16), 69% included at least one measure of utilization, 75% of an outcome, 50% of appropriateness, 19% of cost, 50% patient-reported, 13% provider-reported, and 6% patient-provider interaction. Of published studies, 34% included at least one measure of an unintended consequence as compared to 63% of ongoing studies. CONCLUSIONS AND RELEVANCE: Most published studies focused on reductions in utilization rather than on clinically meaningful measures (e.g., improvements in appropriateness, patient-reported outcomes) or unintended consequences. Investigators should systematically incorporate more clinically meaningful measures into their study designs, and sponsors should develop standardized guidance for the evaluation of interventions to reduce low-value care.
Subject(s)
Medical Overuse/statistics & numerical data , Attitude of Health Personnel , Humans , Medical Overuse/economics , Patient Reported Outcome Measures , Quality Indicators, Health CareABSTRACT
PURPOSE OF REVIEW: The purpose of this chapter is to highlight current recommendations regarding colorectal cancer (CRC) screening and post-polypectomy surveillance colonoscopy in older adults and to review the available literature in order to help inform decision-making in this age group. RECENT FINDINGS: Age is a risk factor for CRC; however, older adults with a history of prior screening are at lower risk for CRC compared to those who have never been screened. Decision-making for CRC screening and post-polypectomy surveillance colonoscopy in older adults is complex and several factors including age, screening history, comorbidities, functional status, bowel preparation, prior experiences, preferences, and barriers need to be considered when weighing risks and benefits. Recent guidelines have started to incorporate life expectancy and prior screening history into their recommendations; however, how to incorporate these factors into actual clinical practice is less clear. There are limited data on the relative benefits of screening and surveillance in older adults and therefore, at this time, decision-making should be individualized and incorporate patient preferences in addition to medical factors.