RESUMEN
Background: A large trial of postmenopausal women with breast cancer reported an imbalance in colorectal cancer events with aromatase inhibitors (AIs), compared with tamoxifen in the adjuvant setting. This unexpected signal was observed within 3 years of randomization. To date, no observational studies have examined this important safety question in the natural setting of clinical practice. Thus, the objective of this study was to determine whether AIs, when compared with tamoxifen, are associated with increased risk of colorectal cancer in postmenopausal women with breast cancer. Patients and methods: Using the UK Clinical Practice Research Datalink, we identified women, at least 55 years of age, with breast cancer newly treated with either AIs or tamoxifen between 1 January 1996 and 30 September 2015, with follow-up until 30 September 2016. High-dimensional propensity score-adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of incident colorectal cancer associated with AIs when compared with tamoxifen overall, by cumulative duration of use, and time since initiation. All exposures were lagged by 1 year for latency considerations. Results: A total of 9701 and 8893 patients initiated AIs and tamoxifen as first-line hormonal therapy (median follow-up of 2.4 and 2.9 years, respectively). Compared with tamoxifen, AIs were not associated with an increased risk of colorectal cancer (incidence rates of 150 per 100 000 person-years in both groups; adjusted HR: 0.90, 95% CI: 0.53-1.52). Similarly, there was no evidence of an association with cumulative duration of use (P-heterogeneity = 0.54), and time since initiation (P-heterogeneity = 0.66). Conclusions: In this first population-based study, the use of AIs was not associated with an increased risk of colorectal cancer. These findings should provide reassurance to the concerned stakeholders.
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Antineoplásicos Hormonales/efectos adversos , Inhibidores de la Aromatasa/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias Colorrectales/epidemiología , Neoplasias Primarias Secundarias/epidemiología , Anciano , Quimioterapia Adyuvante/efectos adversos , Quimioterapia Adyuvante/métodos , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Posmenopausia , Riesgo , Tamoxifeno/uso terapéuticoRESUMEN
BACKGROUND: The modern management of acute non-variceal upper gastrointestinal bleeding is centred on endoscopy, with recourse to interventional radiology and surgery in refractory cases. The appropriate use of intervention to optimize outcomes is reviewed. METHODS: A literature search was undertaken of PubMed and the Cochrane Central Register of Controlled Trials between January 1990 and April 2013 using validated search terms (with restrictions) relevant to upper gastrointestinal bleeding. RESULTS: Appropriate and adequate resuscitation, and risk stratification using validated scores should be initiated at diagnosis. Coagulopathy should be corrected along with blood transfusions, aiming for an international normalized ratio of less than 2·5 to proceed with possible endoscopic haemostasis and a haemoglobin level of 70 g/l (excluding patients with severe bleeding or ischaemia). Prokinetics and proton pump inhibitors (PPIs) can be administered while awaiting endoscopy, although they do not affect rebleeding, surgery or mortality rates. Endoscopic haemostasis using thermal or mechanical therapies alone or in combination with injection should be used in all patients with high-risk stigmata (Forrest I-IIb) within 24 h of presentation (possibly within 12 h if there is severe bleeding), followed by a 72-h intravenous infusion of PPI that has been shown to decrease further rebleeding, surgery and mortality. A second attempt at endoscopic haemostasis is generally made in patients with rebleeding. Uncontrolled bleeding should be treated with targeted or empirical transcatheter arterial embolization. Surgical intervention is required in the event of failure of endoscopic and radiological measures. Secondary PPI prophylaxis when indicated and Helicobacter pylori eradication are necessary to decrease recurrent bleeding, keeping in mind the increased false-negative testing rates in the setting of acute bleeding. CONCLUSION: An evidence-based approach with multidisciplinary collaboration is required to optimize outcomes of patients presenting with acute non-variceal upper gastrointestinal bleeding.
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Endoscopía/métodos , Hemorragia Gastrointestinal/prevención & control , Enfermedad Aguda , Embolización Terapéutica/métodos , Tratamiento de Urgencia/métodos , Fibrinolíticos/uso terapéutico , Infecciones por Helicobacter/prevención & control , Helicobacter pylori , Hemostasis Quirúrgica/métodos , Humanos , Grupo de Atención al Paciente/organización & administración , Medición de Riesgo/métodos , Segunda Cirugía/métodos , Resultado del TratamientoRESUMEN
Long wait times for health care have become a significant issue in Canada. As part of the Canadian Association of Gastroenterology's Human Resource initiative, a questionnaire was developed to survey patients regarding wait times for initial gastroenterology consultation and its impact. A total of 916 patients in six cities from across Canada completed the questionnaire at the time of initial consultation. Self-reported wait times varied widely, with 26.8% of respondents reporting waiting less than two weeks, 52.4% less than one month, 77.1% less than three months, 12.5% reported waiting longer than six months and 3.6% longer than one year. One-third of patients believed their wait time was too long, with 9% rating their wait time as 'far too long'; 96.4% believed that maximal wait time should be less than three months, 78.9% believed it should be less than one month and 40.3% believed it should be less than two weeks. Of those working or attending school, 22.6% reported missing at least one day of work or school because of their symptoms in the month before their appointment, and 9.0% reported missing five or more days in the preceding month. A total of 20.2% of respondents reported being very worried about having a serious disease (ie, scored 6 or higher on 7-point Likert scale), and 17.6% and 14.8%, respectively, reported that their symptoms caused major impairment of social functioning and with the activities of daily living. These data suggest that a significant proportion of Canadians with digestive problems are not satisfied with their wait time for gastroenterology consultation. Furthermore, while awaiting consultation, many patients experience an impaired quality of life because of their gastrointestinal symptoms.
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Gastroenterología , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Listas de Espera , Canadá , Enfermedades del Sistema Digestivo/diagnóstico , Enfermedades del Sistema Digestivo/terapia , Femenino , Humanos , Masculino , Satisfacción del Paciente , Calidad de Vida , Derivación y Consulta/estadística & datos numéricos , Encuestas y Cuestionarios , Factores de TiempoAsunto(s)
Colestasis Extrahepática/inducido químicamente , Enfermedades del Conducto Colédoco/inducido químicamente , Hemostáticos/efectos adversos , Minerales/efectos adversos , Colestasis Extrahepática/terapia , Enfermedades del Conducto Colédoco/terapia , Humanos , Esfinterotomía Endoscópica/efectos adversos , Irrigación TerapéuticaRESUMEN
BACKGROUND: Canadian wait time data are available for the treatment of cancer and heart disease, as well as for joint replacement, cataract surgery and diagnostic imaging procedures. Wait times for gastroenterology consultation and procedures have not been studied, although digestive diseases pose a greater economic burden in Canada than cancer or heart disease. METHODS: Specialist physicians completed the practice audit if they provided digestive health care, accepted new patients and recorded referral dates. For patients seen for consultation or investigation over a one-week period, preprogrammed personal digital assistants were used to collect data including the main reason for referral, initial referral and consultation dates, procedure dates (if performed), personal and family history, and patient symptoms, signs and test results. Patient triaging, appropriateness of the referral and timeliness of care were noted. RESULTS: Over 10 months, 199 physicians recorded details of 5559 referrals, including 1903 visits for procedures. The distribution of total wait times (from referral to procedure) nationally was highly skewed at 91/203 days (median/75th percentile), with substantial interprovincial variation: British Columbia, 66/185 days; Alberta, 134/284 days; Ontario, 110/208 days; Quebec, 71/149 days; New Brunswick, 104/234 days; and Nova Scotia, 42/84 days. The percentage of physicians by province offering average-risk screening colonoscopy varied from 29% to 100%. DISCUSSION: Access to specialist gastroenterology care in Canada is limited by long wait times, which exceed clinically reasonable waits for specialist treatment. Although exhibiting some methodological limitations, this large practice audit sampling offers broadly generalized results, as well as a means to identify barriers to health care delivery and evaluate strategies to address these barriers, with the goals of expediting appropriate care for patients with digestive health disorders and ameliorating the personal and societal burdens imposed by digestive diseases.
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Enfermedades del Sistema Digestivo/diagnóstico , Enfermedades del Sistema Digestivo/terapia , Gastroenterología , Accesibilidad a los Servicios de Salud , Derivación y Consulta/estadística & datos numéricos , Listas de Espera , Canadá , Humanos , Auditoría Médica , Pautas de la Práctica en Medicina/estadística & datos numéricos , Factores de TiempoRESUMEN
BACKGROUND: Monitoring wait times and defining targets for care have been advocated to improve health care delivery related to cancer, heart, diagnostic imaging, joint replacements and sight restoration. There are few data on access to care for digestive diseases, although they pose a greater economic burden than cancer or heart disease in Canada. The present study compared wait times for specialist gastroenterology care with recent, evidence-based, consensus-defined benchmark wait times for a range of digestive diseases. METHODS: Total wait times from primary care referral to investigation were measured for seven digestive disease indications by using the Practice Audit in Gastroenterology program, and were benchmarked against consensus recommendations. RESULTS: Total wait times for 1903 patients who were undergoing investigation exceeded targets for those with probable cancer (median 26 days [25th to 75th percentiles eight to 56 days] versus target of two weeks); probable inflammatory bowel disease (101 days [35 to 209 days] versus two weeks); documented iron deficiency anemia (71 days [19 to 142 days] versus two months); positive fecal occult blood test (73 days [36 to 148 days] versus two months); dyspepsia with alarm symptoms (60 days [23 to 140 days] versus two months); refractory dyspepsia without alarm symptoms (126 days [42 to 225 days] versus two months); and chronic constipation and diarrhea (141 days [68 to 264 days] versus two months). A minority of patients were seen within target times: probable cancer (33% [95% CI 20% to 47%]); probable inflammatory bowel disease (12% [95% CI 1% to 23%]); iron deficiency anemia (46% [95% CI 37% to 55%]); positive occult blood test (41% [95% CI 28% to 54%]); dyspepsia with alarm symptoms (51% [95% CI 41% to 60%]); refractory dyspepsia without alarm symptoms (33% [95% CI 19% to 47%]); and chronic constipation and diarrhea (21% [95% CI 14% to 29%]). DISCUSSION: Total wait times for the seven indications exceeded the consensus targets; 51% to 88% of patients were not seen within the target wait time. Multiple interventions, including adoption of evidence-based management guidelines and provision of economic and human resources, are needed to ensure appropriate access to digestive health care in Canada. Outcomes can be evaluated by the 'point-of-care', practice audit methodology used for the present study.
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Enfermedades del Sistema Digestivo/diagnóstico , Enfermedades del Sistema Digestivo/terapia , Gastroenterología , Accesibilidad a los Servicios de Salud , Derivación y Consulta/estadística & datos numéricos , Listas de Espera , Canadá , Consenso , Humanos , Auditoría Médica , Guías de Práctica Clínica como Asunto , Sociedades Médicas , Factores de TiempoRESUMEN
BACKGROUND: Inappropriate use of intravenous proton pump inhibitors is prevalent. AIM: To assess appropriateness of intravenous proton pump inhibitor prescribing. METHODS: Retrospective review of in-patient prescribing of intravenous pantoprazole over a 2-month period in 2004, in an academic centre. Prescribing was deemed appropriate before and after endoscopic haemostasis, and in fasting individuals requiring a proton pump inhibitor. RESULTS: Amongst 107 patients, 49 (46%) had upper gastrointestinal bleeding. Overall, 33 (31%, 95% CI: 22-41%) received appropriate therapy (indication, dose and duration), 61 (57%, 95% CI: 47-67%) had an inappropriate indication, and 13 (12%, 95% CI: 7-20%) had an incorrect treatment dose or duration. Therapy was appropriate in 20 (41%, 95% CI: 27-55%) with upper gastrointestinal bleeding, and 13 (22%, 95% CI: 12-33%) in the non-upper gastrointestinal bleeding group. Appropriate prescribing rates decreased (from 41% to 16%, 95% on difference CI: 14-38%) when considering intravenous proton pump inhibitor use while awaiting endoscopy as inappropriate. Significant predictors of inappropriate use were increasing age and decreasing mean daily dose, with a trend for prescriptions written during evening shifts. CONCLUSION: Inappropriate intravenous proton pump inhibitor utilization was most frequent in the non-upper gastrointestinal bleeding group, mostly for unrecognized indications. Educational interventions to optimize utilization should target prescribing in older patients, those receiving lower mean daily doses, and, perhaps, prescribing outside regular hours.
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Utilización de Medicamentos , Hemorragia Gastrointestinal/prevención & control , Inhibidores de la Bomba de Protones , Bombas de Protones/administración & dosificación , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/normas , Quebec/epidemiología , Estudios RetrospectivosRESUMEN
OBJECTIVE: To determine whether antiplatelet agents are associated with endoscopic sphincterotomy-related haemorrhage as few well-controlled data exist on this controversial issue. METHODS: A case-control study in a tertiary care setting included cases with bleeding following endoscopic sphincterotomy, matched with 2-3 controls selected according to age +/- 15 years, sex, and procedural date+/- 2 years. Cases and controls were compared for possible risk factors of postendoscopic sphincterotomy bleeding (presence of a coagulopathy and cholangitis). The main outcome measurement was the association between the use of antiplatelet medications and postendoscopic sphincterotomy bleeding after adjustment for possible confounding. RESULTS: The 40 cases [mean age 68 +/- 17 (s.d.) years, 50% female] and 86 controls [68 +/- 16 years, 50% female] were comparable except for differences noted in International Normalized Ratio (INR) (>2 in four cases vs. two controls), and pre-endoscopic sphincterotomy cholangitis (45% vs. 20%). Amongst cases, 13% were on aspirin and 3% on clopidogrel; 17% of controls took aspirin, and 4% a non-steroidal anti-inflammatory drug. 53% of cases bled immediately; the remainder haemorrhaged at 2 +/- 3 days. After adjustment for an elevated INR and cholangitis, exposure to antiplatelet agents was not significantly associated with procedure-related bleeding (odds ratio = 0.41, 95% CI [ 0.13; 1.31]). CONCLUSION: This case-control study provides controlled data suggesting that antiplatelet agents do not significantly increase the risk of clinically-important bleeding related to endoscopic sphincterotomy. The low prevalences of non-steroidal anti-inflammatory drugs and clopidogrel use limit any definite conclusion on their elective use before endoscopic sphincterotomy.
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Antiinflamatorios no Esteroideos/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Complicaciones Posoperatorias/prevención & control , Esfinterotomía Endoscópica , Anciano , Anciano de 80 o más Años , Animales , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: The reflux disease questionnaire (RDQ) is a short, patient-completed instrument. AIMS: To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia. METHODS: HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily. RESULTS: High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions. CONCLUSIONS: The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.
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Antiulcerosos/uso terapéutico , Dispepsia/tratamiento farmacológico , Esomeprazol/uso terapéutico , Reflujo Gastroesofágico/tratamiento farmacológico , Pirosis/tratamiento farmacológico , Encuestas y Cuestionarios/normas , Adulto , Canadá , Ácido Gástrico/metabolismo , Humanos , Masculino , PsicometríaRESUMEN
BACKGROUND AND STUDY AIMS: The optimal approach for diagnosing sclerosing cholangitis remains unclear in the face of competing imaging technologies. We aimed to determine the most cost-effective strategy. PATIENTS AND METHODS: A decision model compared three approaches in the work-up of patients with suspected sclerosing cholangitis; all included an initial test, with, if unsuccessful, performance of a second cholangiographic method. They were magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP), termed "MRCP_ERCP", ERCP and MRCP ("ERCP_MRCP"), or ERCP and a repeat ERCP ("ERCP_ERCP"). The implications of true and false positive and negative results with regard to costs and procedural complications were considered, including that of a liver biopsy, if indicated as a result of a negative work-up in the face of persistent clinical suspicion. The unit of effectiveness adopted was that of a correct diagnosis. Probability assumptions were derived from published literature, while cost estimates were derived from time-motion microanalyses or a national database, and expressed in Canadian dollars at 2004 values. Sensitivity analyses, including clinically relevant threshold analyses, were carried out. RESULTS: The average cost-effectiveness ratios were $414 for MRCP_ERCP, $1101 for ERCP_MRCP and $1123 for ERCP_ERCP, per correct diagnosis. The ERCP_MRCP strategy was dominated (more expensive and less effective) by MRCP_ERCP, while ERCP_ERCP was more effective and more costly than MRCP_ERCP, at $289,292 per additional correct diagnosis. Sensitivity and threshold analyses confirmed the robustness of these findings. CONCLUSIONS: Based on the model assumptions, a strategy of initial MRCP, followed, if negative, by ERCP is currently the most cost-effective approach to the work-up of patients with suspected sclerosing cholangitis.
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Colangiopancreatografia Retrógrada Endoscópica/métodos , Pancreatocolangiografía por Resonancia Magnética/métodos , Colangitis Esclerosante/diagnóstico , Modelos Estadísticos , Adolescente , Adulto , Anciano , Colangiopancreatografia Retrógrada Endoscópica/economía , Pancreatocolangiografía por Resonancia Magnética/economía , Análisis Costo-Beneficio , Diagnóstico Diferencial , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Probabilidad , Reproducibilidad de los Resultados , Estudios Retrospectivos , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Gastric intestinal metaplasia (GIM) is the premalignant stage of gastric cancer; however, consensus on its management has not been established. AIM: To determine the risk factors for gastric cancer in a population of patients with GIM to guide the appropriate clinical recommendations in a low prevalence area for gastric cancer. METHODS: This was a retrospective cohort study. Ninety-one patients with GIM diagnosed between 2004 and 2014 were recruited for surveillance EGD every 6-12 months until a diagnosis of gastric cancer or completion of the planned 5-year follow-up duration. Possible risk factors for gastric cancer were assessed. RESULTS: At initial presentation, 81 of the 91 patients (89%) had complete GIM, whereas the remaining 11% had a study entry diagnosis of incomplete GIM. No cancer developed amongst patients with complete GIM. In contrast, five of the 10 patients exhibiting incomplete GIM (50%) progressed to high-grade dysplasia (n=2) or cancer (n=3). Male gender (P=.027), and incomplete GIM (P=.001) were associated with high-risk histology (dysplasia or cancer) by study end. A trend suggested a possible association with smoking (P=.08). CONCLUSION: Male patients and those with incomplete GIM are at greatest risk of developing dysplasia or early gastric cancer. Further studies in determining optimal surveillance intervals and impact on cancer incidence and mortality are still required.
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Gastritis Atrófica/epidemiología , Metaplasia/epidemiología , Neoplasias Gástricas/epidemiología , Estómago/patología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Gastro-oesophageal reflux disease has wide-ranging effects on patients' lives. AIM: To review systematically the effects of gastro-oesophageal reflux disease on work productivity. METHODS: Studies of gastro-oesophageal reflux disease and work productivity were identified in a systematic literature search and their results were valued in US dollars using the human capital method. Work productivity loss was defined as absence from work (absenteeism) plus reduced effectiveness while working (presenteeism). RESULTS: Eight eligible studies were included. Reported work productivity loss among individuals with gastro-oesophageal reflux disease ranged from 6% to 42% and was primarily because of presenteeism (6-40%) rather than absenteeism (<1% to 7%). Reported losses were greatest in patients experiencing sleep disturbance because of gastro-oesophageal reflux disease, and lowest in individuals from the general population taking appropriate prescription medication. Work productivity impairment correlated with symptom severity and responded to acid-suppressive therapy. Assuming a 40-h working week and average wages in the US, the weekly mean productivity loss per employee with gastro-oesophageal reflux disease can be estimated between 2.4 (62 dollars) and 16.6 h (430 dollars), depending on the population studied. CONCLUSIONS: Gastro-oesophageal reflux disease has a substantial impact on employee productivity, primarily by impairing productivity while working. Further studies are needed to confirm that this impact can be decreased by acid-suppressive therapy.
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Reflujo Gastroesofágico/economía , Enfermedades Profesionales/economía , Adulto , Eficiencia , Femenino , Humanos , Industrias , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Proton pump inhibitors have dramatically improved the management options available for patients with acid-related disorders. In patients with gastro-oesophageal reflux disease, currently available proton pump inhibitors provide an excellent outcome for the majority; however, they do not provide optimal pH control in many. Proton pump inhibitors co-therapy reduces, but does not eliminate, the risk of gastrointestinal ulcers and complications in patients taking non-steroidal anti-inflammatory drugs, while in patients with upper gastrointestinal bleeding, it may be difficult to reach and maintain the current therapeutic target of intragastric pH of 6-7. This article reviews the effectiveness of current antisecretory therapy in these three acid-related diseases and areas of unmet clinical need. The potential role of a proton pump inhibitor with an extended duration of action and enhanced acid control from a single daily dose, particularly improved control at night, is discussed. Finally, therapy that could be administered without regard to time of day and/or food intake would offer dosing flexibility and thus have a positive effect on patients' compliance.
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Antiácidos/uso terapéutico , Antiulcerosos/uso terapéutico , Enfermedades Gastrointestinales/tratamiento farmacológico , Inhibidores de la Bomba de Protones , Antiinflamatorios no Esteroideos/efectos adversos , Reflujo Gastroesofágico/tratamiento farmacológico , Enfermedades Gastrointestinales/inducido químicamente , Hemorragia Gastrointestinal/tratamiento farmacológico , Humanos , Concentración de Iones de Hidrógeno , Úlcera Péptica/tratamiento farmacológicoRESUMEN
BACKGROUND: The prevalence of Barrett's oesophagus in patients undergoing gastroscopy may be influenced by possible referral bias. AIM: To present the prevalence of Barrett's oesophagus from the the Canadian Adult Dyspepsia Empirical Therapy Prompt Endoscopy study and to explore potential risk factors for its presence. METHODS: Patients had not been on treatment for dyspepsia for 2-4 weeks prior to endoscopy, which was performed within 10 working days of presentation. RESULTS: Barrett's oesophagus was endoscopically suspected in 53 of 1040 cases (5%) and histologically confirmed by the presence of intestinal metaplasia in 25 (2.4%). The prevalence of biopsy-proven Barrett's oesophagus was 4% in patients with dominant reflux-like symptoms. Sixty-four percent with confirmed Barrett's oesophagus had dominant reflux-like symptoms compared with 37% without Barrett's oesophagus. Barrett's oesophagus was more common in patients >50 years of age; 68% of cases were males. The mean duration of symptoms was 10 years, yet 16% had symptoms of <1-year duration. Endoscopic reflux oesophagitis was present in 68% of confirmed Barrett's oesophagus patients. CONCLUSIONS: Barrett's oesophagus is confirmed on biopsy in about half of endoscopically suspected Barrett's oesophagus patients. Barrett's oesophagus is more common in males, in those with dominant reflux-like symptoms, and in patients with a longer symptom history.
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Esófago de Barrett/epidemiología , Dispepsia/epidemiología , Anciano , Esófago de Barrett/complicaciones , Esófago de Barrett/diagnóstico , Canadá/epidemiología , Estudios de Cohortes , Dispepsia/diagnóstico , Dispepsia/etiología , Esofagitis Péptica/diagnóstico , Esofagitis Péptica/epidemiología , Esofagitis Péptica/etiología , Esofagoscopía/métodos , Femenino , Reflujo Gastroesofágico/diagnóstico , Reflujo Gastroesofágico/epidemiología , Reflujo Gastroesofágico/etiología , Infecciones por Helicobacter/complicaciones , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/epidemiología , Helicobacter pylori/aislamiento & purificación , Hernia Hiatal/diagnóstico , Hernia Hiatal/epidemiología , Hernia Hiatal/etiología , Humanos , Masculino , Persona de Mediana Edad , PrevalenciaRESUMEN
BACKGROUND: Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials. AIM: To validate the 7-point Global Overall Symptom scale. METHODS: The Global Overall Symptom scale uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized-controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test-retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated. RESULTS: Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively. CONCLUSION: The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials.
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Dispepsia/diagnóstico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antiulcerosos/uso terapéutico , Dispepsia/complicaciones , Dispepsia/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Omeprazol/uso terapéutico , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND: Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease. METHODS: We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up. RESULTS: Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64). CONCLUSIONS: The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.
Asunto(s)
Reflujo Gastroesofágico/complicaciones , Antiácidos/uso terapéutico , Antiulcerosos/uso terapéutico , Estudios Transversales , Esomeprazol/uso terapéutico , Femenino , Reflujo Gastroesofágico/tratamiento farmacológico , Pirosis/tratamiento farmacológico , Pirosis/etiología , Humanos , Estudios Longitudinales , Masculino , Registros Médicos , Persona de Mediana Edad , Calidad de Vida , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
INTRODUCTION: The diversity, technical skills required, and risk inherent to advanced endoscopy techniques all contribute to complex training curricula and steep learning curves. Since trainees develop endoscopy skills at different rates, there has been a shift towards competency-based training and certification. Validated endoscopy performance measures for trainees are, therefore, necessary. The aim of this systematic review was to describe and critically assess the existing evidence regarding measures of performance for trainees in advanced endoscopy. METHODS: A systematic review of the literature from January 1980 to January 2016 was carried out using the MEDLINE, EMBASE, CENTRAL, and ISI Web of knowledge databases. MeSH terms related to 'advanced endoscopy' and 'performance' were applied to a highly sensitive search strategy. The main outcomes were face, content, and construct validity, as well as reliability. RESULTS: The literature search yielded 1,662 studies and 77 met the inclusion criteria after abstract and full-text review (endoscopic retrograde cholangiopancreatography (ERCP)=23, endoscopic ultrasound (EUS)=30, colonoscopic polypectomy (CP)=11, balloon-assisted enteroscopy (BAE)=7, luminal stenting=3, radiofrequency ablation (RFA)=2, and endoscopic muscosal resection (EMR)=1). Good validity and reliability were found for measurement tools of overall performance in ERCP, EUS and CP, with applications for both patient-based and simulator training models. A number of specific technical skills were also shown to be valid measures of performance. These include: selective biliary cannulation, sphincterotomy, biliary stent placement, stone extraction and procedure time for ERCP; pancreatic solid mass T-staging, EUS-guided fine needle aspiration (EUS-FNA) procedure time, number of EUS-FNA passes and puncture precision for EUS; procedure time and en bloc resection rate for CP; retrograde fluoroscopy time for BAE; and mean number of endoscopy sessions required to achieve complete eradication of intestinal metaplasia (CIEM) for RFA. The evidence for EMR and luminal stenting is of insufficient quality to make recommendations. CONCLUSIONS: We have identified multiple valid and readily available performance measures for advanced endoscopy trainees for ERCP, EUS, CP, BAE and RFA procedures. These tools should be considered in advanced endoscopy training programs wishing to move away from apprenticeship-based training and towards competency-based learning with the help of patient-based and simulator tools.