Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial.

OBJECTIVE: This study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term. Design: open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions. PARTICIPANTS: A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres. SETTING: Primary Care Centers in Canary Islands (Spain). INTERVENTION: The intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI). OUTCOME MEASURE: Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables. RESULTS: Compared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group). CONCLUSIONS: Assessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227.

Informed consent in clinical research; Do patients understand what they have signed? / El consentimiento informado en investigación clínica; ¿Entienden los pacientes lo que firman?

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial (AU)

El consentimiento informado es una parte esencial de la investigación y su firma es imprescindible para llevar a cabo la mayor parte de los estudios clínicos. Su fin es poner en conocimiento del paciente lo que implica su participación en el estudio que se le propone. Sin embargo, cada vez más, su complejidad y extensión los hacen difícilmente comprensibles, por lo que se corre el riesgo de que el paciente dé su autorización sin haberlo leído previamente o sin haber entendido lo que en él se le expone. En este sentido, los comités éticos de investigación clínica y los farmacéuticos, especialistas en farmacia hospitalaria y atención primaria como parte integrante de los mismos, cumplen un importante y difícil papel en la defensa de los derechos de los pacientes. En ellos se revisan exhaustivamente estos documentos para garantizar que todos los requisitos que exige la normativa estén contemplados y, al mismo tiempo, que sean de fácil comprensión para los potenciales participantes en un estudio (AU)

Informed consent in clinical research; Do patients understand what they have signed?

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

El consentimiento informado es una parte esencial de la investigación y su firma es imprescindible para llevar a cabo la mayor parte de los estudios clínicos. Su fin es poner en conocimiento del paciente lo que implica su participación en el estudio que se le propone. Sin embargo, cada vez más, su complejidad y extensión los hacen difícilmente comprensibles, por lo que se corre el riesgo de que el paciente dé su autorización sin haberlo leído previamente o sin haber entendido lo que en él se le expone. En este sentido, los comités éticos de investigación clínica y los farmacéuticos, especialistas en farmacia hospitalaria y atención primaria como parte integrante de los mismos, cumplen un importante y difícil papel en la defensa de los derechos de los pacientes. En ellos se revisan exhaustivamente estos documentos para garantizar que todos los requisitos que exige la normativa estén contemplados y, al mismo tiempo, que sean de fácil comprensión para los potenciales participantes en un estudio.

New technologies as a strategy to decrease medication errors: how do they affect adults and children differently?

BACKGROUND: Medication error can occur throughout the drug treatment process, with special relevance in children given the risk of adverse effects resulting from a medication error is more prevalent than in adults. The significance of medication error in children is also greater because small error that would be tolerated in adults can cause significant damage in children. Moreover, the likelihood of injury is higher than in adults. DATA SOURCES: Based on the data published, most medication errors take place in prescribing and administration stages in both populations. Taking in account that child's risk factors are different from those of adults, with some specific causes to pediatrics, we have reviewed available data about new technologies as a strategy to reduce pediatric medication errors. RESULTS: Even though there is a lack of standardized definitions and terminology that makes studies difficult to compare, we checked that new technologies have proven to be effectives in reducing medication errors, mainly computerized physician order entry (CPOE) and platforms to aid decision-making. However, we also observed that the use of these informatic tools can also generate new errors. CONCLUSIONS: Implementation of CPOE programs for pediatrics, communication improvement between healthcare professionals taking care of admitted children and the knowledge of these programs should be the mayor priorities for the safety of hospitalized children.

Reasons for initiation of proton pump inhibitor therapy for hospitalised patients and its impact on outpatient prescription in primary care.

BACKGROUND: Proton-pump-inhibitors are often prescribed unnecessarily in hospitals, which in turn induces their prescriptions after discharge. OBJECTIVE: To evaluate patients starting treatment with proton-pump-inhibitors during hospitalisation and proportion of inappropriate prescriptions. Patient risk factors and whether initiation in hospital induced their continuation in ambulatory care were also analyzed. METHODS: An observational, cross-sectional study in a tertiary hospital (1350 beds) was carried out on the first Tuesday in February 2015. Pharmacists screened admitted patients treated with proton-pump-inhibitors using an electronic prescription program (FarmaTools®-5.0). They also checked patients' home medications before admission by accessing a primary care program (Horus®). Authorized indications according to Spanish-Medicines-Agency and those recommended in Spanish-Clinical-Practice-Guidelines were considered appropriate. Hospital-medical-records were checked to know whether proton-pump-inhibitors were prescribed at discharge. RESULTS: Three hundred seventy nine patients were analysed. Two hundred ninety four of them were prescribed proton-pump-inhibitors (77.6%). Treatment was initiated during admission for 143 patients (48.6%, 95% CI: 42.8-54.5). Of them, 91 (63.6%, 95% CI: 55.2-71.5) were inappropriate, mainly due to its inclusion unnecessarily in protocols associated with surgeries or diseases (56 cases of 91, 61.5%). Additional inappropriate indications were surgical stress ulcer prophylaxis for surgeries without bleeding risks (19.8%) and polypharmacy without drugs that increase the risk of bleeding (18.7%). Of 232 discharge reports assessed, in 153 (65.9%, 95% CI: 59.5-72), proton-pump-inhibitor continuation was recommended, of them, 51 (33.3%) were initiated at admission. CONCLUSION: In hospitalized patients there is a high prevalence of prescription of proton-pump-inhibitors unnecessarily. The superfluous use is often associated with the prescription of treatment protocols. Those treatments started in the hospital generally did not contribute to over-use existing primary care, most of them were removed at discharge.

Reasons for initiation of proton pump inhibitor therapy for hospitalised patients and its impact on outpatient prescription in primary care

BACKGROUND: Proton-pump-inhibitors are often prescribed unnecessarily in hospitals, which in turn induces their prescriptions after discharge. OBJECTIVE: To evaluate patients starting treatment with proton-pump-inhibitors during hospitalisation and proportion of inappropriate prescriptions. Patient risk factors and whether initiation in hospital induced their continuation in ambulatory care were also analyzed. METHODS: An observational, cross-sectional study in a tertiary hospital (1350 beds) was carried out on the first Tuesday in February 2015. Pharmacists screened admitted patients treated with proton-pump-inhibitors using an electronic prescription program (FarmaTools®-5.0). They also checked patients' home medications before admission by accessing a primary care program (Horus®). Authorized indications according to Spanish-Medicines-Agency and those recommended in Spanish-Clinical-Practice- Guidelines were considered appropriate. Hospital-medical-records were checked to know whether proton-pump-inhibitors were prescribed at discharge. RESULTS: Three hundred seventy nine patients were analysed. Two hundred ninety four of them were prescribed proton-pumpinhibitors (77.6%). Treatment was initiated during admission for 143 patients (48.6%, 95% CI: 42.8-54.5). Of them, 91 (63.6%, 95% CI: 55.2-71.5) were inappropriate, mainly due to its inclusion unnecessarily in protocols associated with surgeries or diseases (56 cases of 91, 61.5%). Additional inappropriate indications were surgical stress ulcer prophylaxis for surgeries without bleeding risks (19.8%) and polypharmacy without drugs that increase the risk of bleeding (18.7%). Of 232 discharge reports assessed, in 153 (65.9%, 95% CI: 59.5-72), proton-pump-inhibitor continuation was recommended, of them, 51 (33.3%) were initiated at admission. CONCLUSION: In hospitalized patients there is a high prevalence of prescription of proton-pump-inhibitors unnecessarily. The superfluous use is often associated with the prescription of treatment protocols. Those treatments started in the hospital generally did not contribute to over-use existing primary care, most of them were removed at discharge

Prolongación del intervalo QT inducido por fármacos: ¿conocemos sus riesgos? / Drug-induced QT interval prolongation: Do we know the risks?

La muerte súbita cardiaca es una causa importante de mortalidad en los países desarrollados. La mayoría de ellas derivan de arritmias ventriculares agudas que, en algunas ocasiones, se producen como consecuencia de la prolongación del intervalo QT. Un importante factor de riesgo para esta alteración es el uso de fármacos que prolongan este intervalo. De hecho, en los últimos años, uno de los motivos más frecuentes de retirada del mercado de medicamentos o de restricciones de uso ha sido la prolongación del intervalo QT, e implica tanto fármacos cardiovasculares como no cardiovasculares. Dada la gravedad que puede conllevar la aparición de un suceso por esta causa, es importante que los clínicos conozcan los riegos del uso de estos fármacos en determinados pacientes. En esta revisión analizamos los fármacos que prolongan el intervalo QT, los factores de riesgo que pueden influir y las combinaciones de fármacos que pueden agravar esta situación (AU)

Sudden cardiac death is an important cause of mortality in developed countries, most of them being consequence of acute ventricular arrhythmias. These arrhythmias, in some cases, owe to QT interval prolongation. A major risk factor for this condition is the use of drugs that prolong the QT interval. In fact, in recent years, one of the most common reasons for drug withdrawal or usage restrictions has been drug induced QT interval prolongation that involves both cardiovascular and non-cardiovascular drugs. Taking into account the severity that the occurrence of such an event may have, it is important for clinicians to know the risks of these drugs in certain patients. In this review we analyze the drugs that prolong the QT interval, the risk factors that can enhance QT prolongation and the drug interactions that can increase these risks (AU)

[Drug-induced QT interval prolongation: do we know the risks?]. / Prolongación del intervalo QT inducido por fármacos: ¿conocemos sus riesgos?

Sudden cardiac death is an important cause of mortality in developed countries, most of them being consequence of acute ventricular arrhythmias. These arrhythmias, in some cases, owe to QT interval prolongation. A major risk factor for this condition is the use of drugs that prolong the QT interval. In fact, in recent years, one of the most common reasons for drug withdrawal or usage restrictions has been drug induced QT interval prolongation that involves both cardiovascular and non-cardiovascular drugs. Taking into account the severity that the occurrence of such an event may have, it is important for clinicians to know the risks of these drugs in certain patients. In this review we analyze the drugs that prolong the QT interval, the risk factors that can enhance QT prolongation and the drug interactions that can increase these risks.

Análisis del número y diseño de ensayos clínicos y de la prescripción de medicamentos para indicaciones no incluidas en su ficha técnica en pacientes hospitalizados pediátricos / Analysis of clinical trials and off-label drug use in hospitalized pediatric patients

Introducción. La falta de ensayos clínicos en pediatría (ECP) conduce a la prescripción off-label de medicamentos en niños (POMN). Nuestro objetivo fue analizar el número y diseño de ECP y de POMN en los últimos años. Población, material y métodos. Estudio observacional, retrospectivo de ECP y POMN desde 2007 hasta 2012 realizados en un hospital infantil con 252 camas. Se analizó el número y diseño de ECP y de POMN por año y sus características. Resultados. Se evaluaron 87 ECP y 449 principios activos correspondientes a 1049 medicamentos prescritos a niños hospitalizados. De ellos, 117 (26%) se utilizaron fuera de prospecto. Los ECP fueron en aumento desde 2008 hasta 2011. Ese año, el 52,2% de los ECP fueron no aleatorizados ni controlados y solo 39,1% fueron aleatorizados controlados. Un 77% de los fármacos investigados eran prescritos fuera de prospecto. La POMN se mantuvo estable durante el estudio. Conclusiones. En nuestro hospital, ha aumentado la investigación en pediatría en los últimos años; los estudios no aleatorizados ni controlados fueron los más frecuentes. La POMN no se ha modificado.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26%) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2% of PCTs were non-randomized and uncontrolled studies, and only 39.1% were randomized, controlled trials. Of all studied drugs, 77% corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26%) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2% of PCTs were non-randomized and uncontrolled studies, and only 39.1% were randomized, controlled trials. Of all studied drugs, 77% corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed.

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients. / Analysis of clinical trials and off-label drug use in hospitalized pediatric patients.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed childrens hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26

) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2

of PCTs were non-randomized and uncontrolled studies, and only 39.1

were randomized, controlled trials. Of all studied drugs, 77

corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed.

Potential medication errors associated with computer prescriber order entry.

INTRODUCTION: To assess the frequency of medication errors (ME) induced or enhanced by computerized physician order entry (CPOE). Error type, drug classes involved, specialty, patient outcome and system failures were also evaluated. METHODS: Observational quantitative study in a large tertiary care medical center over March 2012 3 years after CPOE implementation. Pharmacists detected ME associated with CPOE (those that wouldn't have occurred if the clinician had prescribed manually) and unassociated in pharmacological treatments in inpatients of 13 specialties (421 beds). Main outcome measured were ME associated and unassociated with CPOE. RESULTS: We found 714 ME with 85.857 drug prescriptions (a 0.8 % error rate, 95 % CI 0.6-0.7). Percentage of error associated with CPOE was 77.7 %. The main types of error related to CPOE were wrong medication selection (20.9 %) and improper data placement (20.3 %). Failures with medications prescribed in primary care, unavailable in the hospital pharmacy, were involved in 21.6 % of all ME. Errors involving surgical specialties were double those involving medical specialties (1.2 vs. 0.6 %). Most ME associated with CPOE were potential errors (90 %). During the study system failures occurred four times. CONCLUSIONS: The use of CPOE minimises the occurrence of medication errors, however, they still occur. Most errors are associated with the CPOE technology. We therefore face a new challenge in the prevention of ME that require a change in strategy for patient safety. Continued training of prescribers, standardization of the electronic prescription programs and integration between computer applications in hospitals and with primary care should be a priority.

Colquicina: ¿qué hay de nuevo, viejo? / Colchicine: what's up, doc?

En los últimos años se ha incrementando notablemente el uso de colquicina fuera de sus indicaciones autorizadas (off-label), fundamentalmente en la enfermedad cardiovascular y, en concreto, en la prevención de recurrencias tras pericarditis aguda o recurrente y de pericarditis tras cirugía cardíaca. Sin embargo, no es un fármaco exento de riesgos debido a su estrecho margen terapéutico, interacciones farmacológicas potencialmente graves y toxicidad asociada a una elevada morbimortalidad. En esta revisión analizamos los beneficios aportados por la colquicina en la enfermedad cardiovascular, los riesgos derivados de su utilización y las últimas recomendaciones para un uso seguro de este antiguo fármaco (AU)

Over de past years use off-label of colchicine has notably increased, mainly as a result of the latest studies published about its efficacy in the prevention of recurrence after acute or recurrent pericarditis and pericarditis after cardiac surgery. Nevertheless, colchicine use has been associated with serious drug interactions and toxicity with high morbimortality.Taking into account the recent results about the efficacy of colchicine in pericarditis management, we envisage an increase in the use of this drug by clinicians. In this review we analyse the risks and current recommendations for a safety use of this ancient drug (AU)

[Colchicine: what's up, doc?]. / Colquicina: ¿qué hay de nuevo, viejo?

Over de past years use off-label of colchicine has notably increased, mainly as a result of the latest studies published about its efficacy in the prevention of recurrence after acute or recurrent pericarditis and pericarditis after cardiac surgery. Nevertheless, colchicine use has been associated with serious drug interactions and toxicity with high morbimortality. Taking into account the recent results about the efficacy of colchicine in pericarditis management, we envisage an increase in the use of this drug by clinicians. In this review we analyse the risks and current recommendations for a safety use of this ancient drug.

Strategies for improving documentation and reducing medication errors related to drug allergy.

New technologies like computerized physician order entry systems, that includes a support alert for drug allergies, can be an effective tool to prevent medical errors related to drug hypersensitivity most of them caused by lack of documentation and information.