RESUMEN
BACKGROUND: Observational studies have described racial differences in inflammatory bowel disease (IBD) genetics, clinical manifestations, and outcomes. Whether race impacts response to biologics in IBD is unclear. We conducted a post hoc analysis of phase 2 and 3 randomized clinical trials in ulcerative colitis to evaluate the effect of race on response to golimumab. METHODS: We analyzed pooled individual-level data from induction and maintenance trials of golimumab through the Yale Open Data Access Project. The primary outcome was clinical response. Secondary outcomes were clinical remission and endoscopic healing. Multivariable logistic regression was performed comparing White vs racial minority groups (Asian, Black, or other race), adjusting for potential confounders. RESULTS: There were 1006 participants in the induction (18% racial minority) and 783 participants in the maintenance (17% racial minority) trials. Compared with White participants, participants from racial minority groups had significantly lower clinical response (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.28-0.66), clinical remission (aOR, 0.41; 95% CI, 0.22-0.77), and endoscopic healing (aOR, 0.48; 95% CI, 0.31-0.74) at week 6. Participants from racial minority groups also had significantly lower clinical remission (aOR, 0.46; 95% CI, 0.28-0.74) and endoscopic healing (aOR, 0.63; 95% CI, 0.41-0.96) at week 30. There were no racial differences in placebo response rates. CONCLUSIONS: Ulcerative colitis participants from racial minority groups were less likely to achieve clinical response, clinical remission, and endoscopic healing with golimumab compared with White participants in induction and maintenance trials. Further studies are needed to understand the impact of race on therapeutic response in IBD.
Racial disparities exist in inflammatory bowel disease, but the influence of race on response to biologic therapy is unclear. In pooled analysis of golimumab clinical trials, participants from racial minority groups were less likely to achieve clinical efficacy compared with White participants.
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Colitis Ulcerosa , Enfermedades Inflamatorias del Intestino , Humanos , Anticuerpos Monoclonales/uso terapéutico , Colitis Ulcerosa/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Inducción de RemisiónRESUMEN
Longstanding and extensive ulcerative colitis (UC) are associated with the subsequent development of colorectal cancer (CRC). This article summarizes key strategies for colonoscopic surveillance, the most widely used and evidence-based method of CRC prevention. As currently constituted and practiced, surveillance examinations every 1 to 3 years with lesion detection and removal using high-definition endoscopic systems with or without pancolonic spray-dye chromoendoscopy is the best method for mitigating the development of CRC morbidity and mortality. For patients with primary sclerosing cholangitis with UC, surveillance should begin at the time of diagnosis and colonoscopy should be performed annually.
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Colitis Ulcerosa/complicaciones , Colonoscopía/métodos , Neoplasias Colorrectales/etiología , Neoplasias Colorrectales/prevención & control , Vigilancia de la Población/métodos , Colangitis Esclerosante/complicaciones , Colitis Ulcerosa/patología , Humanos , RiesgoRESUMEN
Background/Aims: Statins have been postulated to lower the risk of colorectal neoplasia. No studies have examined any possible chemopreventive effect of statins in patients with inflammatory bowel disease (IBD) undergoing colorectal cancer (CRC) surveillance. This study examined the association of statin exposure with dysplasia and CRC in patients with IBD undergoing dysplasia surveillance colonoscopies. Methods: A cohort of patients with IBD undergoing colonoscopic surveillance for dysplasia and CRC at a single academic medical center were studied. The inclusion criteria were IBD involving the colon for ≥8 years (or any colitis duration if associated with primary sclerosing cholangitis [PSC]) and at least two colonoscopic surveillance exams. The exclusion criteria were CRC or high-grade dysplasia (HGD) prior to or at enrollment, prior colectomy, or limited (<30%) colonic disease. The primary outcome was the frequency of dysplasia and/or CRC in statin-exposed versus nonexposed patients. Results: A total of 642 patients met the inclusion criteria (57 statin-exposed and 585 nonexposed). The statin-exposed group had a longer IBD duration, longer follow-up period, and more colonoscopies but lower inflammatory scores, less frequent PSC and less use of thiopurines and biologics. There were no differences in low-grade dysplasia, HGD, or CRC development during the follow-up period between the statin-exposed and nonexposed groups (21.1%, 5.3%, 1.8% vs 19.2%, 2.9%, 2.9%, respectively). Propensity score analysis did not alter the overall findings. Conclusions: In IBD patients undergoing surveillance colonoscopies, statin use was not associated with reduced dysplasia or CRC rates. The role of statins as chemopreventive agents in IBD remains controversial.
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Colitis/tratamiento farmacológico , Neoplasias Colorrectales/epidemiología , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Vigilancia de la Población/métodos , Adulto , Colangitis Esclerosante/complicaciones , Estudios de Cohortes , Colitis/complicaciones , Colonoscopía/estadística & datos numéricos , Neoplasias Colorrectales/etiología , Neoplasias Colorrectales/prevención & control , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/estadística & datos numéricos , Femenino , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Masculino , Persona de Mediana Edad , Prevalencia , Factores de Riesgo , Factores de TiempoRESUMEN
OBJECTIVES: Surveillance colonoscopy is thought to prevent colorectal cancer (CRC) in patients with long-standing colonic IBD, but data regarding the frequency of surveillance and the findings thereof are lacking. Our aim was to determine whether consecutive negative surveillance colonoscopies adequately predict low neoplastic risk. DESIGN: A multicentre, multinational database of patients with long-standing IBD colitis without high-risk features and undergoing regular CRC surveillance was constructed. A 'negative' surveillance colonoscopy was predefined as a technically adequate procedure having no postinflammatory polyps, no strictures, no endoscopic disease activity and no evidence of neoplasia; a 'positive' colonoscopy was a technically adequate procedure that included at least one of these criteria. The primary endpoint was advanced colorectal neoplasia (aCRN), defined as high-grade dysplasia or CRC. RESULTS: Of 775 patients with long-standing IBD colitis, 44% (n=340) had >1 negative colonoscopy. Patients with consecutive negative surveillance colonoscopies were compared with those who had at least one positive colonoscopy. Both groups had similar demographics, disease-related characteristics, number of surveillance colonoscopies and time intervals between colonoscopies. No aCRN occurred in those with consecutive negative surveillance, compared with an incidence rate of 0.29 to 0.76/100 patient-years (P=0.02) in those having >1 positive colonoscopy on follow-up of 6.1 (P25-P75: 4.6-8.2) years after the index procedure. CONCLUSION: Within this large surveillance cohort of patients with colonic IBD and no additional high-risk features, having two consecutive negative colonoscopies predicted a very low risk of aCRN occurrence on follow-up. Our findings suggest that longer surveillance intervals in this selected population may be safe.
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Colitis/patología , Neoplasias del Colon/patología , Colonoscopía , Lesiones Precancerosas/patología , Adulto , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Vigilancia de la Población , Valor Predictivo de las Pruebas , Factores de RiesgoRESUMEN
BACKGROUND & AIMS: Patients with inflammatory bowel disease (IBD) and primary sclerosing cholangitis (PSC, termed PSC-IBD) are at increased risk for colorectal cancer, but their risk following a diagnosis of low-grade dysplasia (LGD) is not well described. We aimed to determine the rate of advanced colorectal neoplasia (aCRN), defined as high-grade dysplasia and/or colorectal cancer, following a diagnosis of indefinite dysplasia or LGD in this population. METHODS: We performed a retrospective, longitudinal study of 1911 patients with colonic IBD (293 with PSC and 1618 without PSC) who underwent more than 2 surveillance colonoscopies from 2000 through 2015 in The Netherlands or the United States (9265 patient-years of follow-up evaluation). We collected data on clinical and demographic features of patients, as well as data from each surveillance colonoscopy and histologic report. For each surveillance colonoscopy, the severity of active inflammation was documented. The primary outcome was a diagnosis of aCRN during follow-up evaluation. We also investigated factors associated with aCRN in patients with or without a prior diagnosis of indefinite dysplasia or LGD. RESULTS: Patients with PSC-IBD had a 2-fold higher risk of developing aCRN than patients with non-PSC IBD. Mean inflammation scores did not differ significantly between patients with PSC-IBD (0.55) vs patients with non-PSC IBD (0.56) (P = .89), nor did proportions of patients with LGD (21% of patients with PSC-IBD vs 18% of patients with non-PSC IBD) differ significantly (P = .37). However, the rate of aCRN following a diagnosis of LGD was significantly higher in patients with PSC-IBD (8.4 per 100 patient-years) than patients with non-PSC IBD (3.0 per 100 patient-years; P = .01). PSC (adjusted hazard ratio [aHR], 2.01; 95% CI, 1.09-3.71), increasing age (aHR 1.03; 95% CI, 1.01-1.05), and active inflammation (aHR, 2.39; 95% CI, 1.63-3.49) were independent risk factors for aCRN. Dysplasia was more often endoscopically invisible in patients with PSC-IBD than in patients with non-PSC IBD. CONCLUSIONS: In a longitudinal study of almost 2000 patients with colonic IBD, PSC remained a strong independent risk factor for aCRN. Once LGD is detected, aCRN develops at a higher rate in patients with PSC and is more often endoscopically invisible than in patients with only IBD. Our findings support recommendations for careful annual colonoscopic surveillance for patients with IBD and PSC, and consideration of colectomy once LGD is detected.
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Colangitis Esclerosante/complicaciones , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/patología , Enfermedades Inflamatorias del Intestino/complicaciones , Adolescente , Adulto , Colonoscopía , Femenino , Histocitoquímica , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Estudios Retrospectivos , Medición de Riesgo , Estados Unidos/epidemiología , Adulto JovenRESUMEN
Background: Therapeutic drug monitoring (TDM) may improve the efficacy and cost-effectiveness of anti-TNF therapy. A standardized approach of utilizing TDM has not been established. The objective of this study was to determine gastroenterologists' attitudes and barriers toward TDM of anti-TNF therapy in clinical practice. Methods: An 18-question survey was distributed to members of the American College of Gastroenterology and Crohn's and Colitis Foundation via email. We collected physician characteristics, practice demographics, and data regarding TDM use and perceived barriers to TDM. Factors associated with the use of TDM were determined by logistic regression analysis. Results: A total of 403 gastroenterologists from 42 US states (76.4% male) met inclusion criteria: 90.1% use TDM, mostly reactively for secondary loss of response (87.1%) and primary nonresponse (66%); 36.6% use TDM proactively. The greatest barriers to TDM implementation were uncertainty about insurance coverage (77.9%), high out-of-pocket patient costs (76.4%), and time lag from serum sample to result (38.5%). Factors independently associated with the use of TDM and proactive TDM were practice in an academic setting (P = 0.019), and more IBD patients seen per month (P = 0.015), and Crohn's and Colitis Foundation membership (P < 0.001), and more IBD patients on anti-TNF therapy per month (P = 0.006), respectively. If all barriers were removed, an additional one-third of physicians would apply proactive TDM. Conclusions: Lack of insurance coverage, high out-of-pocket costs, and the time lag from test to result limit use of TDM in the United States. Validation of low-cost assays, point of care testing, and studies that standardize the use of TDM are needed to make TDM more commonplace.
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Actitud del Personal de Salud , Monitoreo de Drogas/psicología , Gastroenterólogos/psicología , Adhesión a Directriz/estadística & datos numéricos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infliximab/uso terapéutico , Guías de Práctica Clínica como Asunto , Femenino , Fármacos Gastrointestinales/uso terapéutico , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
BACKGROUND & AIMS: Patients with colitis have an increased risk of colorectal cancer, compared with persons without colitis. Many studies have shown chromoendoscopy (CE) to be superior to standard methods of detecting dysplasia in patients with colitis at index examination. We performed a prospective, longitudinal study to compare standard colonoscopy vs CE in detecting dysplasia in patients with inflammatory bowel diseases in a surveillance program. METHODS: We analyzed data from 68 patients (44 men, 24 women) diagnosed with ulcerative colitis (n = 55) or Crohn's disease (n = 13) at Mount Sinai Medical Center from September 2005 through October 2011. The patients were followed from June 2006 through October 2011 (median, 27.8 months); each patient was analyzed by random biopsy, targeted white light examination (WLE), and CE. Specimens were reviewed by a single blinded pathologist. The 3 methods were compared by using the generalized estimating equations method, and the odds ratios (ORs) for detection of dysplasia were calculated (primary outcome). Time to colectomy was analyzed by using the Cox model. RESULTS: In the 208 examinations conducted, 44 dysplastic lesions were identified in 24 patients; 6 were detected by random biopsy, 11 by WLE, and 27 by CE. Ten patients were referred for colectomy, and no carcinomas were found. At any time during the study period, CE (OR, 5.4; 95% confidence interval [CI], 2.9-9.9) and targeted WLE (OR, 2.3; 95% CI, 1.0-5.3) were more likely than random biopsy analysis to detect dysplasia. CE was superior to WLE (OR, 2.4; 95% CI, 1.4-4.0). Patients identified as positive for dysplasia were more likely to need colectomy (hazard ratio, 12.1; 95% CI, 3.2-46.2). CONCLUSIONS: In a prospective study of 68 patients with inflammatory bowel diseases, CE was superior to random biopsy or WLE analyses in detecting dysplasia in patients with colitis during an almost 28-month period. A negative result from CE examination was the best indicator of a dysplasia-free outcome, whereas a positive result was associated with earlier referral for colectomy.
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Colitis/complicaciones , Neoplasias Colorrectales/diagnóstico , Endoscopía/métodos , Enfermedades Inflamatorias del Intestino/complicaciones , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Biopsia , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto JovenRESUMEN
Serrated colorectal polyps, which, besides hyperplastic polyps, comprise sessile serrated adenomas/polyps and traditional serrated adenomas, are presumptive precursors of at least 20% of sporadic colorectal carcinomas; however, their significance in patients with inflammatory bowel disease is unclear. We retrospectively evaluated 78 serrated polyps, removed over a 14-year period from 6602 inflammatory bowel disease patients undergoing endoscopic surveillance, with respect to morphologic, clinicopathologic, and molecular features, and compared rates of advanced neoplasia (high-grade dysplasia and carcinoma) development following the index serrated polyp diagnosis to reference inflammatory bowel disease cohorts without serrated polyps. Serrated polyps negative for dysplasia, which morphologically resembled sporadic sessile serrated adenoma/polyps, occurred mainly in females, in the proximal colon, and contained BRAF mutations. Serrated polyps with low-grade dysplasia resembled sporadic traditional serrated adenomas and occurred mainly in males, in the distal colon, and contained KRAS mutations. Serrated polyps indefinite for dysplasia were morphologically heterogeneous, but similar to serrated polyps positive for low-grade dysplasia with respect to male predominance, left-sided location, and KRAS mutation rates. Rates of prevalent neoplasia associated with serrated polyps positive for low-grade dysplasia, indefinite for dysplasia, and negative for dysplasia were 76, 39, and 11%, respectively (P<0.001). Actuarial 10-year rates of incident advanced neoplasia after an initial diagnosis of serrated polyp positive for low-grade dysplasia, indefinite for dysplasia, and negative for dysplasia were 17, 8, and 0%, respectively, the first and last being significantly different (P=0.02) and comparable to those of corresponding reference populations of inflammatory bowel disease patients with and without low-grade dysplasia at baseline, respectively. We conclude that in serrated polyps from inflammatory bowel disease patients, dysplasia grade correlates with morphology, sex, anatomic location, BRAF and KRAS mutation status, prevalent conventional neoplasia, and rates of advanced neoplasia development.
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Pólipos del Colon/complicaciones , Pólipos del Colon/patología , Enfermedades Inflamatorias del Intestino/complicaciones , Adulto , Anciano , Pólipos del Colon/genética , Neoplasias Colorrectales/complicaciones , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/patología , Femenino , Humanos , Incidencia , Enfermedades Inflamatorias del Intestino/patología , Masculino , Persona de Mediana Edad , Reacción en Cadena de la Polimerasa Multiplex , Mutación , Proteínas Proto-Oncogénicas B-raf/genética , Proteínas Proto-Oncogénicas p21(ras)/genética , Estudios RetrospectivosRESUMEN
OBJECTIVE: Early readmission rates are becoming an integral measure of the quality of care for hospitalized patients with chronic diseases. The incidence and predictors of early readmission in patients with inflammatory bowel disease (IBD) are uncertain. Risk factors for readmission over the first few weeks may differ from those that influence re-hospitalization at later time points. We examined the incidence and predictors of both 30-day and 90-day readmissions among ulcerative colitis (UC) patients. MATERIALS AND METHODS: A retrospective, cohort study was performed including all severe UC patients admitted to a tertiary-care hospital between January 2007 and December 2011. All-cause readmissions to the medical or surgical service within 30 and 90 days were recorded to allow the calculation of early readmission rates. We used multiple logistic regression to analyze demographic, hospital-related, general medical and IBD-specific factors as potential risk factors for readmission. RESULTS: There were a total of 229 patients discharged following hospitalization for severe UC. The 30- and 90-day readmission rates were 11.7% and 20.5%, respectively. Forty-seven percent of early readmissions were for colectomy. In the 30-day analysis, only the presence of extensive colitis (odds ratio 3.59; 95% confidence interval [CI] 1.41-9.13) compared with left-sided disease was independently associated with readmission. Extensive colitis (3.09, 95% CI 1.33-7.08), albumin on admission (0.56, 0.31-0.99) and being admitted to a housestaff service (2.87, 95% CI 1.14-6.54), were independent predictors of readmission at 90 days. CONCLUSIONS: Early readmission is common in IBD. Independent risk factors for early readmission included extensive colitis, admission albumin, and being admitted to a housestaff service.
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Colectomía/métodos , Colitis Ulcerosa/terapia , Hospitalización/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Adulto , Colitis Ulcerosa/complicaciones , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Centros de Atención Terciaria , Adulto JovenRESUMEN
The evidence supporting the practice of dysplasia surveillance in inflammatory bowel disease (IBD) has remained sparse, and optimal detection strategies are still lacking. These issues, added to the declining incidence of dysplasia in IBD, have led to much debate over the diagnosis and management of dysplasia. White-light endoscopy with targeted and random biopsies remains the technique of choice for most practicing gastroenterologists. However, during the past decade, a surge of literature has questioned the efficacy of this strategy. Simultaneously, chromoendoscopy has emerged as an alternative, and perhaps superior, technique that has been included in some society guidelines. Nevertheless, many issues remain unclear, such as the best way to implement chromoendoscopy into everyday practice, whether there are any outcome benefits that can be attributed to the use of chromoendoscopy, and, perhaps most importantly, how to manage dysplasia uncovered by this and other advanced techniques. In this article, we discuss the various techniques currently available for dysplasia surveillance in IBD, with a focus on chromoendoscopy. Additionally, we highlight the overarching issues of setting appropriate endpoints and individualizing the care of patients with long-standing colitis.
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BACKGROUND & AIMS: Giant inflammatory polyposis (GIP), characterized by mass-like agglomerations of inflammatory polyps, is a rare complication of inflammatory bowel disease (IBD). We reviewed a series of cases of GIP to determine its diagnostic impact on the clinical and pathologic distinction between ulcerative colitis (UC) and colonic Crohn's disease (CD). METHODS: All colons with GIP resected over a 13-year period were identified prospectively and the corresponding clinical and pathologic records were reviewed. RESULTS: Twelve cases of GIP were identified, accounting for 0.8% of colectomies for IBD during the same time interval. Preoperatively, 6 (50%) patients were diagnosed with UC, 2 (17%) with CD and 4 (33%) with indeterminate colitis (IC). Postoperatively, 6 of the diagnoses (50%) were revised based on strict histopathologic criteria: all 4 diagnoses of IC to UC, one diagnosis of CD to UC, and one diagnosis of UC to CD, for a total of 10 diagnoses of UC (83%) and two of CD (17%). Significantly, 7 of 10 cases with postoperative diagnoses of UC (70%) had Crohn's-like transmural inflammation exclusively within the polyposis segments attributed to fecal entrapment and stasis and accounting for the Crohn's-like clinical complications in these cases. CONCLUSIONS: This case series of GIP, the largest reported from a single center, highlights the high rate of Crohn's-like clinical and pathological manifestations of GIP and their potential to confound the accurate classification of patients with IBD. A diagnosis of UC should not be amended to CD based on the findings of the polyposis segment alone.
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Colitis Ulcerosa/diagnóstico , Pólipos del Colon/patología , Enfermedad de Crohn/diagnóstico , Adolescente , Adulto , Anciano , Colitis Ulcerosa/complicaciones , Colitis Ulcerosa/cirugía , Pólipos del Colon/etiología , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/cirugía , Diagnóstico Diferencial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenAsunto(s)
Terapia de Inmunosupresión/métodos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Neoplasias/complicaciones , Contraindicaciones , Humanos , Huésped Inmunocomprometido , Terapia de Inmunosupresión/efectos adversos , Inmunosupresores/efectos adversos , Inmunosupresores/uso terapéutico , Enfermedades Inflamatorias del Intestino/complicaciones , Neoplasias/inmunología , Purinas/efectos adversos , Purinas/uso terapéutico , Recurrencia , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
BACKGROUND: Inflammatory bowel disease (IBD) patients are at increased risk for venous thromboembolism (VTE) compared to the general population. Practice guidelines recommend pharmacologic prophylaxis for IBD inpatients. AIM: Our aim was to determine the rates of pharmacologic VTE prophylaxis in ulcerative colitis (UC) inpatients at a tertiary referral center. We also assessed potential predictors of pharmacologic prophylaxis. METHODS: We conducted a retrospective cohort study of 377 UC patients between January 1st, 2007 and December 31st, 2011. The medical record of each patient was examined to determine whether pharmacologic VTE prophylaxis was ordered and administered. We conducted multiple logistic regression to determine predictors of pharmacologic prophylaxis. RESULTS: The overall VTE pharmacologic prophylaxis rate was 67.6%. The rate of patients admitted to the medical service was 57.4% compared to 93.5% for those admitted to surgery. In medical patients who received pharmacologic VTE prophylaxis, 34.0% of ordered doses were not given compared to 17.4% of doses in surgical patients (P<0.001). In the multiple logistic regression analysis, having an additional VTE risk factor (OR 2.46, 95% CI 1.41-4.30), extensive colitis (OR 2.26, 95% CI 1.32-3.87) or being admitted to a surgical service (OR 12.03, 95% CI 5.29-27.38) was associated with VTE pharmacologic prophylaxis. CONCLUSIONS: A substantial proportion of medical patients admitted with UC were not ordered for VTE pharmacologic prophylaxis despite current guidelines. Even in patients who were ordered for pharmacologic prophylaxis, one third of doses were not given. Inappropriate prophylaxis may lead to unnecessary morbidity and mortality.
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Anticoagulantes/uso terapéutico , Colitis Ulcerosa/complicaciones , Heparina/uso terapéutico , Tromboembolia Venosa/prevención & control , Adolescente , Adulto , Niño , Preescolar , Femenino , Hospitalización , Humanos , Lactante , Medicina Interna , Masculino , Guías de Práctica Clínica como Asunto , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Servicio de Cirugía en Hospital , Centros de Atención Terciaria , Tromboembolia Venosa/etiología , Adulto JovenRESUMEN
INTRODUCTION: Variation in adherence to management guidelines for inflammatory bowel disease (IBD) suggests variable quality of care. Quality indicators (QIs) can be developed to measure the structure, processes, and outcomes of health care delivery. The RAND/UCLA appropriateness method was used to develop a set of process and outcome QIs to define quality of care for IBD. METHODS: Guidelines and position papers for IBD published from 2006 to 2011 were reviewed for potential QIs, which were rated by a multidisciplinary panel. Potential process and outcome QIs were discussed at 3 moderated in-person meetings, with pre-meeting and post-meeting confidential electronic voting. Panelists rated the validity and feasibility of QIs on a 1 through 9 scale; disagreement was assessed using a validated index. QIs rated above 8 were selected for the final set. RESULTS: More than 500 potential process QIs were extracted from guidelines. Following ratings and discussion by the first panel, 35 process QIs were selected for literature review. After the second panel, 10 process QIs were included in the final set. Candidate outcome QIs were then derived from physician, nurse, and patient input and ratings, in addition to outcomes associated with candidate process QIs. None of the top QIs exhibited disagreement. CONCLUSIONS: A set of QIs for IBD was developed with expert interpretation of the literature and multidisciplinary input. Outcome QIs focused largely on remission and quality of life, whereas process QIs were aimed at therapeutic optimization and patient safety. Evaluation of these QIs in clinical practice is needed to assess the correlation of performance on process QIs with performance on outcome QIs.
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Enfermedades Inflamatorias del Intestino/terapia , Evaluación de Procesos y Resultados en Atención de Salud , Indicadores de Calidad de la Atención de Salud , Procesos de Grupo , Humanos , Seguridad del Paciente , Guías de Práctica Clínica como Asunto , Calidad de Vida , Estados UnidosRESUMEN
BACKGROUND: Inflammatory bowel disease (IBD) patients are at an increased risk of thrombosis, particularly when hospitalized. Several clinical practice guidelines now recommend pharmacologic prophylaxis for hospitalized ulcerative colitis and Crohn's disease patients. It is unclear to what extent gastroenterologists are aware of these recommendations and whether they are administering pharmacologic venous thromboembolism (VTE) prophylaxis appropriately. Our aim was to explore current practice of VTE prophylaxis in hospitalized IBD patients in the United States. METHODS: A survey was mailed electronically to gastroenterologists whose electronic mail address was listed in the American College of Gastroenterology (ACG) database. This survey included clinical vignettes outlining scenarios for consideration of VTE prophylaxis. RESULTS: A total of 6227 surveys were sent to gastroenterologists nationwide, and 591 physicians chose to participate (response rate 9.5%). Respondents (80.6%) believed that hospitalized IBD patients have a higher risk of VTE than other inpatients. A total of 29.1% were unaware of any recommendations addressing pharmacologic prophylaxis included in ACG IBD guidelines and 34.6% would give pharmacologic VTE prophylaxis to a hospitalized patient with severe ulcerative colitis. Heparin VTE prophylaxis use was associated with gastroenterologists who indicated that their practices comprised more than 50% of patients with IBD (P=0.0001), being a physician at an academic hospital (P=0.0001) and providers having less than 5 years practice experience (P=0.003). CONCLUSIONS: Despite reasonable awareness of the increased risk of thrombosis in hospitalized IBD patients, many US gastroenterologists may not follow clinical practice guidelines and use pharmacologic VTE prophylaxis.
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Anticoagulantes/uso terapéutico , Gastroenterología , Heparina/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Pacientes Internos , Pautas de la Práctica en Medicina , Tromboembolia Venosa/prevención & control , Colitis Ulcerosa/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Encuestas de Atención de la Salud , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/prevención & control , Guías de Práctica Clínica como Asunto , Encuestas y Cuestionarios , Resultado del Tratamiento , Estados Unidos , Tromboembolia Venosa/etiología , Recursos HumanosRESUMEN
BACKGROUND: The role of intravenous (IV) cyclosporine in severe Crohn's colitis (CC) is poorly studied. AIM: Our primary aim was to determine the in-hospital colonic resection rate in patients with severe CC who received IV cyclosporine, and the potential predictors of resection among these patients. METHODS: An inpatient pharmacy query of all patients who received IV cyclosporine at Mount Sinai Medical Center for 12.5 years after January 1, 1996 was reviewed. Patients with CC or indeterminate colitis favoring Crohn's were included and their medical records were reviewed. Subsequent need for colonic surgery was assessed. A Kaplan-Meier plot with log-rank testing was performed to determine the rate of colonic surgery avoidance. Forward stepwise logistic regression was performed to determine independent predictors of surgery. RESULTS: Forty-eight patients met our inclusion criteria. Prior thiopurine and anti-tumor necrosis factor (anti-TNF) use was 85% and 69%, respectively. The median follow-up time was 12 months (range, 1 to 60 mo). 12.5% of patients required colonic resection during their admission for IV cyclosporine. Anti-TNF use in the 4 weeks preceding IV cyclosporine was the only predictor of surgery in this setting (P=0.05). The cumulative colonic surgery avoidance rate was 72±13% at 6 months and 59±15% at 12 months. CONCLUSIONS: The use of IV cyclosporine resulted in a low rate of in-hospitalization colonic surgery among CC patients with severe disease, the majority of whom previously failed anti-TNFs and thiopurines.