Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms.

BACKGROUND: Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, including enhancing oversight, improving reliability of central monitoring techniques and helping prepare for database lock and trial analyses. Despite this, there is little evidence to support best practice, and current standard methods may not be optimal. METHODS: We report novel methods from the Trial of Imaging and Schedule in Seminoma Testis (TRISST), a UK-based, multi-centre, phase III trial using paper Case Report Forms to collect data over a 6-year follow-up period for 669 patients. Using an automated database report which summarises the data return rate overall and per centre, we developed a Microsoft Excel-based tool to allow observation of per-centre trends in data return rate over time. The tool allowed us to distinguish between forms that can and cannot be completed retrospectively, to inform understanding of issues at individual centres. We reviewed these statistics at regular trials unit team meetings. We notified centres whose data return rate appeared to be falling, even if they had not yet crossed the pre-defined acceptability threshold of an 80% data return rate. We developed a set method for agreeing targets for gradual improvement with centres having persistent data return problems. We formalised a detailed escalation policy to manage centres who failed to meet agreed targets. We conducted a post-hoc, descriptive analysis of the effectiveness of the new processes. RESULTS: The new processes were used from April 2015 to September 2016. By May 2016, data return rates were higher than they had been at any time previously, and there were no centres with return rates below 80%, which had never been the case before. In total, 10 centres out of 35 were contacted regarding falling data return rates. Six out of these 10 showed improved rates within 6-8 weeks, and the remainder within 4 months. CONCLUSIONS: Our results constitute preliminary effectiveness evidence for novel methods in monitoring and managing data return rates in randomised controlled trials. We encourage other researchers to work on generating better evidence-based methods in this area, whether through more robust evaluation of our methods or of others.

Effect of Endovascular Interventions on General Surgery Trainee Operative Experience; a Comparison of Case Log Reports.

BACKGROUND: Vascular surgery fellowship training has evolved with the widespread adoption of endovascular interventions. The purpose of this study is to examine how general surgery trainee exposure to vascular surgery has changed over time. METHODS: Review of the Accreditation Council for Graduate Medical Education national case log reports for graduating Vascular Surgery Fellows (VF), and general surgery residents (GSR) from 2001 to 2012 was performed. RESULTS: The number of GSR increased from 1021 to 1098, and the number of VF increased from 96 to 121 from 2001 to 2012. The total number of vascular cases done by VF increased by 1161 since 2001 (298-762), whereas the total number of vascular cases done by GSR has decreased by 40% during this time period (186-116). Vascular fellows increase was due primarily to an increase in endovascular experience; a finding not noted in general surgery residents. CONCLUSIONS: Vascular fellow case log changes are due primarily to an increase in endovascular experience that has not been mirrored by general surgery trainees. Open surgery experience has decreased overall for general surgery residents in all major categories, a change not seen in vascular surgery fellows.

Posibilidades de las aplicaciones móviles para el abordaje de la obesidad según los profesionales / Possibilities of mobile applications for managing obesity according to professionals

Introducción: Ante el creciente aumento y la relevancia que han adquirido las aplicaciones para teléfonos móviles (App) en el ámbito de la salud, el objetivo de este trabajo es conocer la visión de los profesionales que se dedican al tratamiento de la obesidad sobre las necesidades y carencias actuales con las que se encuentran, su predisposición al uso de dichas aplicaciones y las funcionalidades que creen que debería tener una aplicación de móvil para el tratamiento de la obesidad. Métodos: Estudio cualitativo realizado mediante entrevistas semiestructuradas a expertos que se dedican al tratamiento de la obesidad. Resultados: Las App fueron consideradas como herramientas que podrían ser útiles para interactuar o tratar con los pacientes. No obstante, la predisposición a usarlas contrasta con la realidad actual, cuando su uso es todavía limitado. Los profesionales consideraron que las App podrían suplir en parte la carencia de contacto diario entre paciente y profesional, y permitirían aumentar la interacción con los pacientes, consiguiendo resultados más favorables en el control del peso, en especial en la mejora de la adherencia y en la motivación. En lo que respecta a funcionalidades y requisitos de las App, los registros de peso, de actividad física y de consumo de alimentos fueron destacados como los factores principales a incluir. Conclusiones: La incorporación de App al tratamiento habitual del sobrepeso y la obesidad requiere todavía una mayor definición de sus funcionalidades, así como del rol del profesional y su participación, tanto en el proceso de su diseño como durante la supervisión del tratamiento (AU)

Introduction: Given the increasing use and importance of mobile telephone applications (apps) in the health setting, this study aimed to ascertain the views of health professionals involved in the treatment of obesity about their current needs and gaps in their requirements, their willingness to use mobile apps, and the features these devices should have for the treatment of obesity. Methods: A qualitative study was conducted through semi-structured interviews with experts treating obesity. Results: The experts believed that apps could be useful to interact or deal with patients. However, their willingness to use apps contrasts with the current limited use of these devices. Practitioners felt that apps could partly compensate for the lack of daily contact between patients and professionals and could increase interaction with patients, achieving more favourable weight control results, especially with regard to improved adherence and motivation. In terms of the functionality and requirements of such apps, the main elements to be included were records of weight, physical activity and food consumption. Conclusions: Adding apps to the existing treatment of overweight and obesity still requires further definition of its functions. Additionally, further investigation is needed into both the role and involvement of professionals in the design process and during treatment (AU)

Estudio LIFAC: evaluación de la utilidad de un libro de incidencias en farmacia comunitaria / LIFAC study: assessment of the usefulness of an incident book in community pharmacy

Objetivo: El farmacéutico comunitario se ve obligado en numerosas ocasiones a atender las necesidades que los pacientes le plantean en demanda de soluciones, mediante actuaciones que la estricta observación de la legalidad vigente le impide realizar pero que su preparación profesional y su cercanía al paciente, avalan. El registro escrito de este tipo de situaciones y la decisión adoptada por el farmacéutico es el objeto de este estudio, con el fin de evaluar su utilidad, categorizar e inventariar las incidencias que se presentan, servir de respaldo de su actuación y mejorar la calidad asistencial al paciente. Métodos: Diseño multicéntrico, nacional y prospectivo. Se ofreció la participación a socios de SEFAC que registraron en formato electrónico (Libro de Incidencias) las incidencias producidas en el quehacer profesional diario según una plantilla de tipos predefinidos acordada por la Comisión de Bioética de SEFAC. Resultados: 170 farmacéuticos comunitarios registraron 1.565 incidencias. 64,7% dispensaciones excepcionales resueltas en un 29,7% mediante la ficha de paciente y un 14,5% tras entrevista farmacéutico-paciente. El 35,3% correspondieron a otros tipos de incidencias: no dispensación por razones clínicas (21,5%) y prescripción incorrecta (14,5%). El grupo terapéutico más implicado fue el de los antiinfecciosos (20,1%) y relacionados con el SNC (18,7%). Conclusiones: El estudio LIFAC pone de manifiesto que el farmacéutico comunitario resuelve situaciones en las que de una u otra manera la salud de los pacientes se ve comprometida. Los participantes perciben que el registro de las incidencias es de gran ayuda para la justificación de su actuación profesional en situaciones complejas o comprometidas (AU)

Aim: The community pharmacist is often obliged to deal with patient needs put to them in terms of demanding solutions, by means of actions that strict observation of prevailing legality prevents carrying out but which comes guaranteed by their professional training and proximity to the patient. Strict record of this kind of situation and the decision taken by the pharmacist is the object of this study, with the purpose of assessing its usefulness, categorizing and making an inventory of the incidents that present, serving as a support for their action and improving the quality of patient care. Methods: Multicenter, national and prospective design. SEFAC (Spanish Society for Community Pharmacy) members were given the opportunity to take part; they made an electronic record (Incident Book) of the incidences that occurred in daily professional work according to a preset template agreed by the SEFAC Bioethics Committee. Results: A total of 170 community pharmacists recorded 1565 incidences; 64.7% cases of exceptional dispensing were resolved in 29.7% and 14.5% by means of the patient record and after a pharmacist-patient meeting, respectively. A total of 35.3% corresponded to other kinds of incident: no dispensing for clinical reasons (21.5%) and incorrect prescription (14.5%). The therapeutic group most involved was anti-infectious drugs (20.1%) and related to the CNS (18.7%). Conclusions: The LIFAC study highlights that the community pharmacist resolves situations in which patient health is in some way seen as compromised. Participants perceive that the record of incidents is of major help to justify their professional work in complex or compromised situations (AU)

ICD-10: are you ready for a brave new world?

The ICD-10 transition will be an evolutionary process. Relying on the EHR or certified coding staff alone will not be sufficient. The EHR can facilitate easy search tools that assist the provider in selecting a diagnosis. Billing staff are an invaluable resource to help validate that coding and documentation are in sync but the burden will clearly rest on the provider. The provider will be juggling a new code structure, drilling down to new levels of complexity and ensuring their documentation supports the specificity of the new codes selected, all while managing a full patient schedule. Education for the provider will be of paramount importance as they navigate this brave new world.

Nos informamos y luego consentimos ¿Digitalmente? / No disponible

No disponible

Assessment of the impact on time to complete medical record using an electronic medical record versus a paper record on emergency department patients: a study.

BACKGROUND: Electronic medical records are becoming an integral part of healthcare delivery. OBJECTIVE: The goal of this study was to compare paper documentation versus electronic medical record for non-traumatic chest pain to determine differences in time for physicians to complete medical records using paper versus electronic mediums. We also assessed physician satisfaction with the electronic format. METHODS: We conducted this before-after study in a single large tertiary care academic emergency department. In the 'Before Period', stopwatches determined the time for paper medical recording. In the 'After Period', a template-based electronic medical record was introduced and the time for electronic recording was measured. The time to record in the before and after periods were compared using a two-sided t test. We surveyed physicians to assess satisfaction. RESULTS: We enrolled 100 non-traumatic patients with chest pain in the before period and 73 in the after period. The documentation time was longer using electronic charting, (9.6±5.9 min vs 6.1±2.5 min; p<0.001). 18 of 20 physicians participating in the after period completed surveys. Physicians were not satisfied with the electronic patient recording for non-traumatic chest pain. CONCLUSIONS: This is the first study that we are aware of which compared paper versus electronic medical records in the emergency department. Electronic recording took longer than paper records. Physicians were not satisfied using this electronic record. Given the time pressures on emergency physicians, a solution to minimise the charting time using electronic medical records must be found before widespread uptake of electronic charting will be possible.

[Structured radiology reports].

The paper reviews the problem of using structured radiology reports. Their salient features are as follows: to work out a protocol in accordance with some pattern, to divide it into subheadings arranged consecutively and logically and broken down by main anatomical structures, types of disease, and study, and to use standardized terminology. The RSNA proposed RadLex system is the most known example of structured reports. The experience in using these protocols has shown that the latter may improve the clearness and informative value of roentgenologists' opinions and alleviate their understanding by physicians of other specialties. However, the systems of writing the structured radiology reports have a number of constraints for the time being, which interfere with their wide clinical introduction. Nonetheless, their use is substantially increasing in the years ahead.

[Radiology report: past, present and future].

The analysis of literature data showed that the creation and implementation of a new form of radiology reports into clinical practice is an actual problem of modern medicine. Although imaging modalities have undergone dramatic evolution over the past century, radiology reporting has remained largely static, in both content and structure. In recent years the necessity to create a structured reporting is widely discussed in the literature. A universal format of radiology report hasn't been found yet. The standard of reporting system is absent, a wide variety of styles in radiology reporting currently exists. The challenging goal is improvement of existing protocols and creation of a new form of radiology reports--the protocols of the future.

Dos años de historia clínica electrónica. Experiencia en un hospital comarcal / Two years experience of computerised medical records in a regional hospital

La implantación de dicho programa fue precedida de un curso acelerado de formación a todos los trabajadores del centro. En el momento de su inicio se decidió que la aplicación informática entraría en funcionamiento en todo el ámbito hospitalario relegando el papel de la historia escrita a mano. Se vivieron días de dificultades durante su desarrollo pero de forma progresiva la historia clínica electrónica ha sido bien aceptada por la mayor parte de los trabajadores del centro. Tras le etapa inicial de acostumbramiento se comenzaron a ver los problemas de diseño de la aplicación así como sus posibles soluciones. En el día de hoy el uso del programa SELENE permite una asistencia sanitaria fluida dentro del hospital aunque existen problemas que precisan de una solución que pasa por una financiación adecuada. La implantación de la historia clínica electrónica en los hospitales públicos es sin duda uno de los grandes cambios experimentados en la asistencia a los pacientes en estos últimos años. Se trata de un proceso progresivo y no exento de dificultades pero que sin duda marcará un hito en la forma de manejar la información en la sanidad. Siguiendo esta estela en noviembre de 2008 se adquirió en el centro donde desarrollamos nuestra actividad quirúrgica el programa informático SELENE perteneciente a la empresa multinacional Siemens (AU)

The introduction of computerised medical records in public hospitals is, without a doubt, one of the biggest changes made in patient health care in the last few years. It is a gradual process and is not exempt from difficulties, but it will surely set a challenge in the way information is handled in health care. Taking this path, in November 2008, the computer program SELENE, from the multinational company Siemens, was purchased in the centre were we carry out our surgical activities. The introduction of this program was preceded by an intensive training course for all the workers in the hospital. At the start, it was decided that the computer application would come into operation throughout the entire hospital, replacing the handwritten records. There were difficult days during its gradual introduction, but the computerised medical record has been well accepted by the great majority of the workers at the centre. After the initial stage of becoming accustomed, design problems started to be seen in the application, as well as their possible solutions. Currently, the use of the SELENE program has led to fluid health care within the hospital, although there are problems which can be resolved with adequate funding (AU)

Enfermería y nuevas tecnologías. Historia clínica electrónica / New technologies and nursing. Use and perception of primary health care nurses about electronic health record

Objetivo: analizar la utilización que efectúan las enfermeras de la Historia Clínica Electrónica (HCE), así como valorar la percepción que tienen de la misma. Método: se realizó un estudio descriptivo observacional transversal durante el año 2010, analizando la percepción de las enfermeras de las consultas de adultos y pediatría de los equipos Atención Primaria de Salud del Baix Llobregat (Cataluña) en las que se utiliza la HCE. Las variables de estudio fueron: sociodemográficas, registro de los cuidados, continuidad asistencial, formación, usabilidad. El análisis estadístico realizado fue descriptivo. Resultados: las enfermeras están bastante de acuerdo en que HCE proporciona «continuidad asistencial» en relación a la atención enfermera (media 2,03, Sd.0,83) y en general (media 2,19, Sd.0,83). Muestran indiferencia respecto a la «usabilidad» de la misma (media 3,26, Sd.0,5), a que facilite el «registro de la información» (media 2,69, Sd.0,68) y a la necesidad de «formación» en el uso de la HCE (media 2,6, Sd.0,59). Se ha detectado que a medida que aumenta la edad de la enfermera manifiesta más acuerdo acerca de que la HCE proporciona mayor continuidad asistencial general. Las valoraciones medias de la continuidad asistencial enfermera, registro de la información y continuidad asistencial en general son mayores cuanto más tiempo llevan utilizando la HCE. Conclusiones: la percepción de la enfermera respecto a la HCE es positiva en cuanto a que proporciona continuidad asistencial y permite intercambiar información de los datos de salud del paciente(AU)

Objective: To analyze the nurses make use of electronic health records (EHR) and assess their perception of it. Method: A descriptive cross-sectional observational study was conducted in 2010 analyzing the nurses' perceptions of adult and pediatric consultations of primary health care teams in Baix Llobregat (Catalonia) in which the EHR is used. The study variables were: registration of care, continuity of care, training, usability and sociodemographic composition of the sample. The statistical analysis was descriptive. Results: Nurses agree that EHR provides «continuity of care» in relation to nursing care (mean 2.03, Sd.0.83) and overall (mean 2.19, Sd.0.83). Show indifference to the «usability» of the EHR (mean 3.26, Sd.0.5), to facilitate the «record information» (mean 2.69, Sd.0.68) and the need for «training» in the use of EHR (mean 2.6, Sd.0.59). It has been found that with increasing age of the nurse, it shows more agreement that the EHR provides greater continuity of care overall. The average ratings of the continuum of care nurse, recording of information, continuity of care in general are greater the lead time using the EHR. Conclusions: The nurses' perceptions regarding the EHR are positive in that it provides continuity of care and to exchange information on patient health data(AU)

Calidad del registro de la información acerca del consumo de antiinflamatorios y analgésicos en la Historia clínica del Centro de Salud / Quality recording of information in the Health Centre medical records on the use of analgesic and anti-inflammatory drugs

Introducción. Analizar en las historias clínicas de un centro de salud la existencia o no de datos acerca del proceso de información sobre los efectos secundarios e interacciones de los analgésicos y antiinflamatorios en una población, y establecer asimismo el perfil de los pacientes respecto a la existencia o no de información a este respecto en su historia clínica. La historia clínica no es solo un documento que nos exige la ley, sino que es o debe ser una herramienta asistencial de primer orden, que facilita y ayuda en el proceso asistencial. La cumplimentación adecuada de las historias clínicas es una obligación del profesional además de ser nuestra herramienta de trabajo, pero en la historia clínica de atención primaria no siempre se registra la información generada durante la práctica asistencial. Material y métodos. Estudio descriptivo, transversal. Se revisaron las historias clínicas de 232 pacientes pertenecientes a los 8 cupos informatizados del centro de salud, mayores de 18 años y que dieron su consentimiento verbal para la inclusión en el estudio, pertenecientes al Centro de Salud Mariano Yago de Yecla (ÁreaV, comunidad de Murcia). Resultados. El 21,6% de los facultativos anota en la historia que proporciona información sobre los efectos secundarios e incompatibilidades de la prescripción de analgésicos y antiinflamatorios. Los factores que se relacionan con la ausencia de haber proporcionado información en la historia clínica son: el tipo de prescripción, el tipo de analgésico y antiinflamatorio prescritos, las variables sobre la función renal y el cumplimiento de la gastroprotección. Conclusiones. En las historias clínicas faltan registros sobre la información que se proporciona al paciente consumidor de analgésicos y antiinflamatorios (AU)

Introduction. To examine medical records within a health centre to determine whether there are data in the information process on the secondary effects and interactions of analgesic and anti-inflammatory drugs, and to determine the patient profile as regards whether or not this information is recorded in their medical records. Material and methods. Descriptive, cross-sectional study based on electronic medical records in the Mariano Yago Primary Care Centre in Yecla (Murcia), Spain. A systematic random sample of 232 electronic medical records was reviewed. All the 232 patients, of legal age, gave their consent to review of their electronic medical records for the purposes of the study. Results. The percentage of doctors who recorded the fact that they had provided information regarding secondary effects and non-compatibilities of the prescription of analgesic and anti-inflammatory drugs was 21.6%. The factors involved in the non- recording of this information in the medical record were the type of prescription, the type of analgesic and anti-inflammatory drug prescribed, glomerular filtration, and adequate gastrointestinal protection. Conclusions. The degree of compliance to patients rights to information about treatment with analgesic and anti-inflammatory drugs is low (AU)

Improving prescribing safety in patients with renal insufficiency in the ambulatory setting: the Drug Renal Alert Pharmacy (DRAP) program.

STUDY OBJECTIVE: To determine whether a computerized Drug Renal Alert Pharmacy (DRAP) program could decrease the rate of medication errors in drug selection or dosing for 15 target drugs in patients with renal insufficiency. DESIGN: Randomized, controlled, population-based effectiveness trial. SETTING: A large integrated health care delivery system. PATIENTS: A total of 32,917 health plan members who were at least 18 years old, had an estimated creatinine clearance of 50 ml/minute or lower, and were not receiving dialysis between December 1, 2003, and February 28, 2005, were randomly assigned to either the intervention group (16,577 patients) or usual care (control) group (16,340 patients). Of the 32,917 patients, 6125 patients (3025 in the intervention group and 3100 in the usual care group) were prescribed at least one target drug and were included in the analysis. INTERVENTION: A computerized tool--the DRAP program--was used to alert pharmacists at the time of dispensing to possible errors in target drug selection and dosing for patients with renal insufficiency. The 15 target drugs were previously identified based on frequency of use in our health care system and risk of serious adverse events. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the proportion of medication errors, defined as target drugs that should be avoided or were dosed inappropriately, in the intervention and usual care groups. The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework was used to evaluate the intervention's potential for translation and generalizability. Among the 6125 patients who received a target drug, no significant differences were noted in age, sex, creatinine clearance, comorbid conditions, and number of target drugs between groups at baseline. Over the 15-month intervention period, the proportion of medication errors was significantly lower in the intervention group than the usual care group (33% vs 49%, p<0.001). After the study period, when the intervention was expanded to both groups, a 20% reduction in errors was sustained in the combined groups over the subsequent 7 months. CONCLUSION: The DRAP program was successful in reducing medication errors for patients with renal insufficiency in an ambulatory setting and was demonstrated to have sustainability after study completion.

Prontuário eletrônico como ferramenta de gestão no consultório odontológico / Eletronic assessment as a tool of management in dentist office

Este trabalho, de revisão de literatura, objetiva descrever a utilização da informática para o crescimento do profissional cirurgião-dentista nos dias atuais, enfatizando o uso do prontuário eletrônico. Descreve-se sua facilidade, validade e confiabilidade, mostrando que o mesmo pode atender, também, à saúde pública e até às autoridades judiciais em caso de processos criminais e cíveis. O momento é de transição entre os prontuários de papel e o eletrônico. A segurança e confiabilidade dos prontuários eletrônicos apoiam-se em princípios de integridade, confiabilidade, disponibilidade, autenticação, autorização, legalidade e auditoria geradas pela certificação digital instituída pela Medida Provisória 2200-2 de 2001.

Electronic synoptic operative reporting: assessing the reliability and completeness of synoptic reports for pancreatic resection.

BACKGROUND: Electronic synoptic operative reports (E-SORs) have replaced dictated reports at many institutions, but whether E-SORs adequately document the components and findings of an operation has received limited study. This study assessed the reliability and completeness of E-SORs for pancreatic surgery developed at our institution. STUDY DESIGN: An attending surgeon and surgical fellow prospectively and independently completed an E-SOR after each of 112 major pancreatic resections (78 proximal, 29 distal, and 5 central) over a 10-month period (September 2008 to June 2009). Reliability was assessed by calculating the interobserver agreement between attending physician and fellow reports. Completeness was assessed by comparing E-SORs to a case-matched (surgeon and procedure) historical control of dictated reports, using a 39-item checklist developed through an internal and external query of 13 high-volume pancreatic surgeons. RESULTS: Interobserver agreement between attending and fellow was moderate to very good for individual categorical E-SOR items (kappa = 0.65 to 1.00, p < 0.001 for all items). Compared with dictated reports, E-SORs had significantly higher completeness checklist scores (mean 88.8 +/- 5.4 vs 59.6 +/- 9.2 [maximum possible score, 100], p < 0.01) and were available in patients' electronic records in a significantly shorter interval of time (median 0.5 vs 5.8 days from case end, p < 0.01). The mean time taken to complete E-SORs was 4.0 +/- 1.6 minutes per case. CONCLUSIONS: E-SORs for pancreatic surgery are reliable, complete in data collected, and rapidly available, all of which support their clinical implementation. The inherent strengths of E-SORs offer real promise of a new standard for operative reporting and health communication.