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BACKGROUND: Statin intolerance is a key barrier to the effective prevention of atherosclerotic cardiovascular disease (ASCVD). Experts do not agree on what it is and how to respond to this problem clinically. OBJECTIVE: To characterize the range of expert recommendations about the care of patients with statin intolerance. METHODS: Systematic review registered in PROSPERO that searched on April 1 2022 in PubMed, EMBASE, Scopus, Cochrane, online textbooks, and specialty textbooks for expert reviews (e.g., review articles and book chapters), systematic reviews, or clinical practice guidelines published in the past 5 years without language restriction. Authors working in duplicate extracted definitions, management recommendations, and supportive evidence cited. RESULTS: We identified 26 eligible articles, none of which described a systematic method to summarize the evidence or to develop and grade recommendations. Of these, 14 (54%) offered a definition of statin intolerance. A sequenced approach to management of statin intolerance was suggested in 24 (92%) articles describing 12 different approaches without supporting evidence of efficacy. Investigating for other causes was the most common first step. All authors suggested rechallenging after a washout period with either the same or other statin. Few considered nonlipid approaches to reducing ASCVD risk and none recommended involving patients in shared decision making. CONCLUSION: We found substantial variability in the definition and management of statin intolerance among experts. Few focused on ASCVD risk reduction and none promoted the participation of patients in shared decision making about how to address the threat of ASCVD with or without statins.
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Aterosclerosis , Enfermedades Cardiovasculares , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Enfermedades Cardiovasculares/prevención & control , Aterosclerosis/tratamiento farmacológico , Aterosclerosis/prevención & controlRESUMEN
BACKGROUND: The burden of treatment can overwhelm people living with type 2 diabetes and lead to poor treatment fidelity and outcomes. Chronic care programs must consider and mitigate the burden of treatment while supporting patients in achieving their goals. OBJECTIVE: To explore what patients with type 2 diabetes and their health providers consider are the workload and the resources they must mobilize, i.e., their capacity, to shoulder it. METHODS: We conducted focus groups comprised of 30 patients and 32 clinicians from three community health centers in Chile implementing the Chronic Care Model to reduce cardiovascular risk in patients with type 2 diabetes. Transcripts were analyzed using thematic content analysis techniques illuminated by the Minimally Disruptive Medicine framework. FINDINGS: Gaining access to and working with their clinicians, implementing complex medication regimens, and changing lifestyles burdened patients. To deal with the distress of the diagnosis, difficulties achieving disease control, and fear of complications, patients drew capacity from their family (mostly men), social environment (mostly women), lay expertise, and spirituality. Clinicians found that administrative tasks, limited formulary, and protocol rigidity hindered their ability to modify care plans to reduce patient workload and support their capacity. CONCLUSIONS: Chronic primary care programs burden patients living with type 2 diabetes while hindering clinicians' ability to reduce treatment workloads or support patient capacity. A collaborative approach toward Minimally Disruptive Medicine may result in treatments that fit the lives and loves of patients and improve outcomes.
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Diabetes Mellitus Tipo 2/terapia , Adulto , Anciano , Chile/epidemiología , Costo de Enfermedad , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Manejo de la Enfermedad , Femenino , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Médicos de Atención Primaria , Investigación CualitativaRESUMEN
Background: Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). Methods: We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Conclusions: In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015).
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Importance: Differences in readmission rates among racial and ethnic minorities have been reported, but data among people with diabetes are lacking despite the high burden of diabetes and its complications in these populations. Objectives: To examine racial/ethnic differences in all-cause readmission among US adults with diabetes and categorize patient- and system-level factors associated with these differences. Design, Setting, and Participants: This retrospective cohort study includes 272â¯758 adult patients with diabetes, discharged alive from the hospital between January 1, 2009, and December 31, 2014, and stratified by race/ethnicity. An administrative claims data set of commercially insured and Medicare Advantage beneficiaries across the United States was used. Data analysis took place between October 2016 and February 2019. Main Outcomes and Measures: Unplanned all-cause readmission within 30 days of discharge and individual-, clinical-, economic-, index hospitalization-, and hospital-level risk factors for readmission. Results: A total of 467â¯324 index hospitalizations among 272â¯758 adults with diabetes (mean [SD] age, 67.7 [12.7]; 143â¯498 [52.6%] women) were examined. The rates of 30-day all-cause readmission were 10.2% (33â¯683 of 329â¯264) among white individuals, 12.2% (11â¯014 of 89â¯989) among black individuals, 10.9% (4151 of 38â¯137) among Hispanic individuals, and 9.9% (980 of 9934) among Asian individuals (P < .001). After adjustment for all factors, only black patients had a higher risk of readmission compared with white patients (odds ratio, 1.05; 95% CI, 1.02-1.08). This increased readmission risk among black patients was sequentially attenuated, but not entirely explained, by other demographic factors, comorbidities, income, reason for index hospitalization, or place of hospitalization. Compared with white patients, both black and Hispanic patients had the highest observed-to-expected (OE) readmission rate ratio when their income was low (annual household income <$40â¯000 among black patients: OE ratio, 1.11; 95% CI, 1.09-1.14; among Hispanic patients: OE ratio, 1.11; 95% CI, 1.07-1.16) and when they were hospitalized in nonprofit hospitals (black patients: OE ratio, 1.10; 95% CI, 1.08-1.12; among Hispanic patients: OE ratio, 1.08; 95% CI, 1.05-1.12), academic hospitals (black patients: OE ratio, 1.16; 95% CI, 1.13-1.20; Hispanic patients: OE ratio, 1.12; 95% CI, 1.06-1.19), or large hospitals (ie, with ≥400 beds; black patients: OE ratio, 1.11; 95% CI, 1.09-1.14; Hispanic patients: OE ratio, 1.09; 95% CI, 1.04-1.14). Conclusions and Relevance: In this study, black patients with diabetes had a significantly higher risk of readmission than members of other racial/ethnic groups. This increased risk was most pronounced among lower-income patients hospitalized in nonprofit, academic, or large hospitals. These findings reinforce the importance of identifying and addressing the many reasons for persistent racial/ethnic differences in health care quality and outcomes.
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Complicaciones de la Diabetes/etnología , Etnicidad/estadística & datos numéricos , Grupos Minoritarios/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Grupos Raciales/estadística & datos numéricos , Reclamos Administrativos en el Cuidado de la Salud , Negro o Afroamericano/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Asiático/estadística & datos numéricos , Comorbilidad , Femenino , Hispánicos o Latinos/estadística & datos numéricos , Hospitales con 300 a 499 Camas/estadística & datos numéricos , Hospitales con más de 500 Camas/estadística & datos numéricos , Hospitales Universitarios/estadística & datos numéricos , Hospitales Filantrópicos/estadística & datos numéricos , Humanos , Renta , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Estados Unidos/epidemiología , Población Blanca/estadística & datos numéricosRESUMEN
OBJECTIVES: To improve the trustworthiness of evidence, studies should be prospectively registered and research reports should adhere to existing standards. We aimed to systematically assess the degree to which endocrinology and internal medicine journals endorse study registration and reporting standards for randomised controlled trials (RCTs), systematic reviews (SRs) and observational studies (ObS). Additionally, we evaluated characteristics that predict endorsement of reporting or registration mechanism by these journals. DESIGN: Meta-epidemiological study. SETTING: Journals included in the 'Endocrinology and Metabolism' and 'General and Internal Medicine' 2017 Journal Citation Reports. PARTICIPANTS: Journals with an impact factor of ≥1.0, focused on clinical medicine, and those who publish RCTs, SRs and ObS were included. PRIMARY OUTCOMES: Requirement of adherence to reporting guideline and study registration as determined from the journals' author instructions. RESULTS: Of the 170 (82 endocrinology and 88 internal medicine) eligible journals, endorsing of reporting standards was the highest for RCTs, with 35 (43%) of endocrine journals and 55 (63%) of internal medicine journals followed by SRs, with 21 (26%) and 48 (55%), respectively, and lastly, by ObS with 41 (50%) of endocrine journals and 21 (24%) of internal medicine journals. In 78 (46%) journals RCTs were required to be registered and published in adherence to the Consolidated Standards of Reporting Trials statement. Only 11 (6%) journals required registration of SRs. Internal medicine journals were more likely to endorse reporting guidelines than endocrine journals except for Strengthening the Reporting of Observational Studies in Epidemiology. No other journal characteristic proved to be an independent predictor of reporting standard endorsement for RCTs besides trial registration. CONCLUSION: Our results highlight that study registration requirement and reporting guideline endorsement are suboptimal in internal medicine and endocrine journals. This malpractice may be further enhanced since endorsement does not imply enforcement, impairing the practice of evidence-based medicine.
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Políticas Editoriales , Endocrinología , Medicina Basada en la Evidencia , Adhesión a Directriz , Medicina Interna , Publicaciones Periódicas como Asunto , Informe de Investigación , Estudios Epidemiológicos , Humanos , Edición , RegistrosRESUMEN
BACKGROUND: The Treatment Burden Questionnaire (TBQ) is a self-reported measure of the effect of treatment workload on patient wellbeing. We sought to validate the TBQ in Spanish and use it to estimate the burden of treatment in Argentinian patients with multiple sclerosis (MS). METHODS: The TBQ was forward-backward translated into Spanish. Two focus groups and 25 semi-structured interviews focused on wording and possible item exclusion. Validation was performed in 2 steps. First, 162 patients across a range of MS severity completed the questionnaire. Confirmatory factor analysis assessed the dimensional structure of the TBQ. Construct validity was assessed by studying correlations with fatigue and quality of life (QoL). Then, in a second cohort of 171 patients, we evaluated the association between TBQ scores and patients' sex, age, education level, employment status, type of MS, disease duration, comorbidities, EDSS, pharmacological treatment and medication adherence. RESULTS: The questionnaire presented a 3-factor structure in which burden was related to pharmacological treatment; comprehensive health assistance; and psycho-social-economic context. Composite reliability was > 0.8 for all factors. TBQ showed positive correlation with fatigue (rs = 0.467, p = 0.006), negative correlation with QoL (rs - 0.446, p = 0.009). For the second cohort, total TBQ score was 43 (SD 29). Lowest scores were observed on self-monitoring (0.53, SD 1.3) and highest for administrative load (4.2, SD 3.4). Inverse association was found between the TBQ score and medication adherence (r 0.243 p = 0.001). TBQ scores also correlated with daily patient pill/injection requirements (r 0.175 p = 0.020). Individuals receiving injectable treatment scored higher than patients on oral drugs (total TBQ 51 (SD 32) vs 39 (SD 27) p = 0.002). CONCLUSIONS: The TBQ in Spanish is a reliable instrument and showed adequate correlation with QoL and adherence scales in MS patients. TBQ may benefit health resources allocation and provide tailor therapeutic interventions to construct a minimally disruptive care.
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Costo de Enfermedad , Esclerosis Múltiple , Calidad de Vida , Encuestas y Cuestionarios , Traducción , Adulto , Argentina , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los ResultadosRESUMEN
INTRODUCTION: Sodium glucose cotransporter 2 (SGLT-2) inhibitors are a relatively new drug-class of glucose-lowering medications. Several trials and systematic reviews have demonstrated their beneficial effect on some macrovascular outcomes. Their effect on microvascular outcomes has been reported as positive in several trials, however, their effect remains uncertain. Therefore, we report the protocol of a systematic review and meta-analysis aimed at determining the effect of SGLT-2 inhibitors regarding patient-important and surrogate microvascular outcomes in patients with type 2 diabetes. METHODS AND ANALYSIS: A comprehensive search will be conducted to find eligible articles from each database's earliest inception to November 2017. These databases will include Ovid, MEDLINE, EMBASE, Web of Science, and Scopus. We will search for randomized controlled trials (RCTs) that compare any of the SGLT-2 inhibitors with any other active treatment or placebo assessing microvascular outcomes in either their primary or secondary outcomes. Reviewers working independently and in duplicate will review all abstracts, and full-text manuscripts for eligibility, and will systematically extract the data and will assess the risk of bias in the included studies. Random-effects models will also be used. ETHICS AND DISSEMINATION: The results of the systematic review will be disseminated via publication in a peer-reviewed journal regardless of outcome and will be presented at relevant conferences. The data we will use do not include individual patient data, so ethical approval is not required PROSPERO REGISTRATION NUMBER: CRD42017076460.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Humanos , Metaanálisis como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Resultado del TratamientoRESUMEN
Patients with diabetes mellitus often have several medical problems and carry a burden imposed by their illness and treatment. Health care often ignores the values, preferences and context of patients, leading to treatments that do not fit into patients overwhelmed lives. Shared Decision Making (SDM) emerges as a way to answer the question: Whats best for the patient?. SDM promotes an empathic conversation between patients and clinicians that integrates the best evidence available with their values, preferences and context. We discuss three SDM approaches for patients with diabetes: one focused on sharing information, another on making choices, and a third one on helping patients and clinicians to talk about how to address the problems of living with diabetes and its comorbidities. Despite the benefits demonstrated in studies conducted in the U.S. and Europe, the implementation of SDM continues to be a challenge. In Latin America, healthcare and socio-economic conditions render the implementation of SDM more challenging. Research aimed to respond to this challenge is necessary. Meanwhile, clinicians can practice SDM by sharing evidence-based information, giving voice to patients values and preferences in making choices, and creating empathic conversations aimed at decisions aligned with patients context, dreams, goals, and life expectations.
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Toma de Decisiones , Diabetes Mellitus/terapia , Participación del Paciente , Relaciones Médico-Paciente , Humanos , América LatinaRESUMEN
Patients with diabetes mellitus often have several medical problems and carry a burden imposed by their illness and treatment. Health care often ignores the values, preferences and context of patients, leading to treatments that do not fit into patients overwhelmed lives. Shared Decision Making (SDM) emerges as a way to answer the question: Whats best for the patient?. SDM promotes an empathic conversation between patients and clinicians that integrates the best evidence available with their values, preferences and context. We discuss three SDM approaches for patients with diabetes: one focused on sharing information, another on making choices, and a third one on helping patients and clinicians to talk about how to address the problems of living with diabetes and its comorbidities. Despite the benefits demonstrated in studies conducted in the U.S. and Europe, the implementation of SDM continues to be a challenge. In Latin America, healthcare and socio-economic conditions render the implementation of SDM more challenging. Research aimed to respond to this challenge is necessary. Meanwhile, clinicians can practice SDM by sharing evidence-based information, giving voice to patients values and preferences in making choices, and creating empathic conversations aimed at decisions aligned with patients context, dreams, goals, and life expectations.
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Humanos , Participación del Paciente , Relaciones Médico-Paciente , Toma de Decisiones , Diabetes Mellitus/terapia , América LatinaAsunto(s)
Glucemia/metabolismo , Complicaciones de la Diabetes/sangre , Diabetes Mellitus/sangre , Diabetes Mellitus/tratamiento farmacológico , Hipoglucemia/sangre , Hipoglucemiantes/administración & dosificación , Biomarcadores/sangre , Complicaciones de la Diabetes/diagnóstico , Complicaciones de la Diabetes/prevención & control , Relación Dosis-Respuesta a Droga , Humanos , Hipoglucemia/etiología , Prevalencia , Pronóstico , Factores de RiesgoRESUMEN
In medicine and endocrinology, there are few clinical circumstances in which clinicians can accurately predict what is best for their patients. As a result, patients and clinicians frequently have to make decisions about which there is uncertainty. Uncertainty results from limitations in the research evidence, unclear patient preferences, or an inability to predict how treatments will fit into patients' daily lives. The work that patients and clinicians do together to address the patient's situation and engage in a deliberative dialogue about reasonable treatment options is often called shared decision making. Decision aids are evidence-based tools that facilitate this process. Shared decision making is a patient-centred approach in which clinicians share information about the benefits, harms, and burden of different reasonable diagnostic and treatment options, and patients explain what matters to them in view of their particular values, preferences, and personal context. Beyond the ethical argument in support of this approach, decision aids have been shown to improve patients' knowledge about the available options, accuracy of risk estimates, and decisional comfort. Decision aids also promote patient participation in the decision-making process. Despite accumulating evidence from clinical trials, policy support, and expert recommendations in endocrinology practice guidelines, shared decision making is still not routinely implemented in endocrine practice. Additional work is needed to enrich the number of available tools and to implement them in practice workflows. Also, although the evidence from randomised controlled trials favours the use of this shared decision making in other settings, populations, and illnesses, the effect of this approach has been studied in a few endocrine disorders. Future pragmatic trials are needed to explore the effect and feasibility of shared decision making implementation into routine endocrinology and primary care practice. With the available evidence, however, endocrinologists can now start to practice shared decision making, partner with their patients, and use their expertise to formulate treatment plans that reflect patient preferences and are more likely to fit into the context of patients' lives. In this Personal View, we describe shared decision making, the evidence behind the approach, and why and how both endocrinologists and their patients could benefit from this approach.
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Toma de Decisiones , Endocrinología/métodos , Endocrinología/normas , Endocrinología/tendencias , Humanos , Atención Dirigida al PacienteRESUMEN
PURPOSE: To explore perceptions and experiences of Peruvian medical students about observed, preferred, and feasible decision-making approaches. METHODS: We surveyed senior medical students from 19 teaching hospitals in 4 major cities in Peru. The self-administered questionnaire collected demographic information, current approach, exposure to role models for and training in shared decision making, and perceptions of the pertinence and feasibility of the different decision-making approaches in general as well as in challenging scenarios. RESULTS: A total of 327 senior medical students (51% female) were included. The mean age was 25 years. Among all respondents, 2% reported receiving both theoretical and practical training in shared decision making. While 46% of students identified their current decision-making approach as clinician-as-perfect-agent, 50% of students identified their teachers with the paternalistic approach. Remarkably, 53% of students thought shared decision making should be the preferred approach and 50% considered it feasible in Peru. Among the 10 challenging scenarios, shared decision making reached a plurality (40%) in only one scenario (terminally ill patients). CONCLUSION: Despite limited exposure and training, Peruvian medical students aspire to practice shared decision making but their current attitude reflects the less participatory approaches they see role modeled by their teachers.
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Actitud del Personal de Salud , Toma de Decisiones , Relaciones Interpersonales , Relaciones Médico-Paciente , Estudiantes de Medicina/psicología , Adulto , Docentes , Femenino , Encuestas Epidemiológicas , Hospitales de Enseñanza , Humanos , Masculino , Perú , Proyectos Piloto , Adulto JovenRESUMEN
Chronic diseases are the leading cause of morbidity and mortality worldwide. These conditions require considerable time investment and resources from the health system in Peru, as well as from patients and their families. Paradoxically, the developed medical strategies for managing these conditions generate a constant and increasing burden for the patient and their environment, which affects quality of life and therapeutic results. In this article, the role of shared decision making and minimal disruptive medicine will be described as strategies to address these problems.
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Enfermedad Crónica/terapia , Toma de Decisiones , Manejo de la Enfermedad , Humanos , PerúRESUMEN
Objective To determine the effect of perioperative blocker treatment in patients having non-cardiac surgery. Design Systematic review and meta-analysis.Data sources Seven search strategies, including searching two bibliographic databases and hand searching seven medical journals.Study selection and outcomes We included randomised controlled trials that evaluated blocker treatment in patients having non-cardiac surgery. Perioperative outcomes within 30 days of surgery included total mortality, cardiovascular mortality, non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke, congestive heart failure, hypotension needing treatment, bradycardia needing treatment, and bronchospasm. Results Twenty two trials that randomised a total of 2437 patients met the eligibility criteria. Perioperative blockers did not show any statistically significant beneficial effects on any of the individual outcomes and the only nominally statistically significant beneficial relative risk was 0.44 (95% confidence interval 0.20 to 0.97, 99% confidence interval 0.16 to 1.24) for the composite outcome of cardiovascular mortality, non-fatal myocardial infarction, and non-fatal cardiac arrest. Methods adapted from formal interim monitoring boundaries applied to cumulative meta-analysis showed that the evidence failed, by a considerable degree, to meet standards for forgoing additional studies. The individual safety outcomes in patients treated with perioperative blockers showed a relative risk for bradycardia needing treatment of 2.27 (95% CI 1.53 to 3.36, 99% CI 1.36 to 3.80) and a nominally statistically significant relative risk for hypotension needing treatment of 1.27 (95% CI 1.04 to 1.56, 99% CI 0.97 to 1.66). Conclusion The evidence that perioperative blockers reduce major cardiovascular events is encouraging but too unreliable to allow definitive conclusions to be drawn...
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Antagonistas Adrenérgicos beta/uso terapéutico , Bradicardia/prevención & control , Enfermedades Cardiovasculares/cirugía , Enfermedades Cardiovasculares/terapia , Medicina Basada en la Evidencia/tendenciasRESUMEN
Evidence-based medicine (EBM) integrates the best available external evidence in the care of individual patients with the individual clinical expertise and the patient preferences. This method has been designed for use in daily clinical practice. We describe the rationale for EBM and its principles and application in this article. EBM enables gastroenterologists to update the knowledge required to provide patients with high quality medical care. EBM requires four steps: a) formulating a clinical question arising from a doubt concerning a patient; b) conducting an efficient literature search to answer this question; c) critically appraising this evidence using explicit methods to selected articles to determine the validity of their design and the clinical relevance of their results; and d) applying these results to the patient (taking into account their values and preferences and personal and social circumstances). In this paper, we explain the principles and basic concepts of EBM and their application to gastroenterology and we provide an extensive compilation of internet databases of valid information relevant to gastroenterologists. We also provide a selection of useful tools for self-directed learning of critical appraisal skills. Link updates can be accessed at the following URL: http://www.enlacesmedicos.com/e.htm