Any progress in informed consenting for cancer treatment? Results from a cross sectional analysis at a comprehensive cancer center.

PURPOSE: Informed consent is required prior to any medical procedure. In the context of cancer treatment, special efforts are needed to inform cancer patients properly about treatment, potential sequelae and alternative therapies. Little is known about the effectiveness of current informed consent strategies and patients' individual satisfaction. Given the heterogeneity in terms of age, education, sex and other factors, detailed understanding of patients' comprehension and perception is the basis for further optimization of the informed consent process, which was the aim of the current investigation. METHODS: Patients with a new cancer diagnosis and recent informed consent were asked to complete a questionnaire about satisfaction, comprehension, time management, physician-patient relationship and other items of the informed consent process. Patients were followed for 6 months and invited to complete a follow-up questionnaire. RESULTS: In total, 89 patients completed the first questionnaire and 52 the follow-up questionnaire. Subjective understanding was assumed high, however, this did not correlate with objective understanding. Age and education were identified as influencing factors for comprehension. 85% of the patients were satisfied with the information provided. A major gap was the information on alternative therapies. Moreover, not all patients perceived the consent dialog as such, and particularly the individual treatment intention partially remained unclear for some patients. CONCLUSIONS: To ensure that informed consent is based on solid understanding, informed consenting must be patient-centered and consider the individual expectations, needs and abilities of cancer patients. Further studies are required to develop tailored informed consent strategies.

At a Moment's Notice: Community Advisory Board Perspectives on Biobank Communication to Supplement Broad Consent.

INTRODUCTION: To address ethical concerns about the of future research authorization, biobanks employing a broad model of consent can design ongoing communication with contributors. Notifying contributors at the time of sample distribution provides one form of communication to supplement broad consent. However, little is known about how community-informed governance might anticipate contributor responses and inform communication efforts. OBJECTIVE: We explored the attitudes of members of a three-site Community Advisory Board (CAB) network. CAB members responded to a hypothetical proposal for notifying biobank contributors at the time of sample distribution to researchers utilizing the biobank. METHODS: We used regularly scheduled CAB meetings to facilitate 3 large-group and 6 small-group discussions. Discussions were audio-recorded, transcribed, and analyzed for thematic content using descriptive thematic analysis. RESULTS: The results challenged our expectation of general support for the proposed communications. While CAB members identified some advantages, they were concerned about several potential harms to biobank contributors and the biobank. The CABs understood biobank communication in terms of an ongoing relationship with the biobank and a personal contribution to research. CONCLUSION: Our findings contribute to the emerging literature on community engagement in biobanking. Additional communication with biobank contributors can serve a variety of value-based objectives to supplement broad consent. Design of communication efforts by biobanks can be improved by CAB members' anticipation of the unintended consequences of additional contact with contributors. CAB members' holistic interpretation of communication efforts suggests that biobank leadership considers all communication options as part of a more comprehensive communications strategy.

Midwifery students': Developing an understanding of being 'with woman'--A qualitative study.

OBJECTIVES: To explore and describe what student midwives, enrolled in one Western Australian (WA) university, had witnessed, learned and experienced regarding the concept of being 'with woman'. DESIGN: A qualitative descriptive design was chosen. SETTING: A university in Perth, Western Australia. PARTICIPANTS: Nineteen student midwives from an undergraduate and a post graduate midwifery course. METHODS: Data were collected from audio-recorded interviews. Thematic analysis of interview transcripts was used to identify commonalities of perceptions and experiences of being 'with woman' for students. Data saturation guided when recruitment ceased and final sample size was achieved. FINDINGS: Student interviews revealed that when considering the concept of being 'with woman' students were able to give descriptors of what they interpreted the meaning of being 'with woman' to be. They also described factors that impacted their learning of how to be 'with woman'. Included in their descriptors were that being 'with woman' enables informed choice, it creates a connection, it means the woman is at the centre of care and that it can occur in all contexts. The factors that impacted their learning of how to be 'with woman' were the importance of positive midwife role models, that providing continuity of care models accelerate learning, that the student role and workload can impact their perceived ability to be with woman and that they are aware it takes time to learn how to be 'with woman'. CONCLUSION AND IMPLICATIONS: The art and skills of being 'with woman' are central to midwifery practice; students in this study were able to demonstrate understanding of the concept and also highlight factors that influence their learning of how to be 'with woman'. Findings can inform how the phenomenon of being 'with woman' can be intentionally introduced into midwifery programs, with particular emphasis on positive midwifery role models, realistic student workload and recognition of the value of the Continuity of Care Experience.

Estudio VARIAR: valoración de la eficacia y seguridad a corto plazo en artritis reumatoide del uso de RItuximab comparado con Antagonistas del factor de necrosis tumoral alfa en segunda línea terapéutica en pacientes con artritis reumatoide Refractarios a un primer antagonista del factor de necrosis tumoral alfa / VARIAR Study: assessment of short-term efficacy and safety of rituximab compared to an tumor necrosis factor alpha antagonists as second-line drug therapy in patients with rheumatoid arthritis refractory to a first tumor necrosis factor alpha antagonist

Objetivo. Evaluar la eficacia y la seguridad a corto plazo del tratamiento de pacientes con artritis reumatoide (AR) con rituximab (RTX) comparado con un anti-TNF (2TNF) tras retirada de un primer anti-TNF. Métodos. Estudio multicéntrico prospectivo, observacional, de práctica clínica de pacientes con AR grave refractaria a anti-TNF que recibieron RTX comparados con los que recibieron un 2TNF. Comparación de las variables de eficacia y respuesta EULAR buena/moderada a los 6 meses. Resultados. Ciento tres pacientes incluidos; 82 alcanzan seguimiento a 6 meses, 73,7% mujeres. Datos basales grupo RTX y 2TNF, respectivamente: 8,6 y 6,6 NAD, 8,8 y 7,5 NAI, 5,45 ± 1,28 y 5,18 ± 1,21 en DAS28 (p=0,048), 41 y 38,7mmHg de VSG, y 1,2 y 1,0 en HAQ. Mejoría en todos los parámetros en ambos grupos sin diferencias significativas (excepto mayor reducción de VSG con RTX). Ausencia de efectos adversos graves. Conclusiones. El uso de RTX en segunda línea de terapia biológica tras fallo a un primer anti-TNF en práctica clínica muestra mejoría en las variables de eficacia y funcionalidad a los 6 meses, sin presentar efectos adversos graves. Estos resultados no difieren de los observados tras el uso de un segundo anti-TNF en el mismo escenario clínico (AU)

Objective. to compare the short-term efficacy and safety of rituximab (RTX) therapy versus anti-TNF in rheumatoid arthritis (RA) patients after discontinuation of a first anti-TNF agent. Methods. prospective observational multicenter study in the clinical practice setting, involving patients with severe RA refractory to a first anti-TNF agent, who received either RTX or a second anti-TNF (2TNF), comparing the efficacy endpoints, EULAR response (Good/Moderate) and safety at 6 months. Results. 103 patients enrolled, 82 completed 6-month follow-up, 73.7% women. Baseline data for RTX and 2TNF groups, respectively: TJC, 8.6 and 6.6; SJC, 8.8 and 7.5; DAS28 score, 5.45 (±1.28) and 5.18 (±1.21) (p=0.048), ESR, 41 and 38.7mmHg; and HAQ, 1.2 and 1.0. Improvement was observed in all parameters, with no significant differences (except for a more marked reduction in ESR with RTX). There were no serious adverse events. Conclusions. RTX use as second-line therapy after anti-TNF failure led to improvements in the efficacy and functional variables at 6 months, with no serious adverse events. These results were comparable to those observed in patients who used a second anti-TNF agent in the same clinical scenario (AU)

Efectos de la técnica de arcos botantes para la abertura de la sutura occipitomastoidea en la cervicalgia mecánica / Effects of flying buttresses for the opening of the occipitomastoid suture in mechanical neck pain

Introducción: La cervicalgia mecánica (CM) podría considerarse un problema de salud pública, ya que afecta a casi la mitad de la población en algún momento de su vida. En el 14% de la población, tiene una duración de 6 meses o más, provocando limitaciones laborales, en las actividades de la vida diaria así y de ocio. Objetivo: Analizar los efectos inmediatos de la técnica con arcos botantes (TAB) para la abertura de la sutura occipitomastoidea (OM), realizada bilateralmente, sobre la amplitud articular cervical, el umbral de dolor a la presión (UDP) y la intensidad del dolor. Material y Métodos: Estudio experimental, controlado, aleatorizado, doble ciego. Treinta (n=30) sujetos con CM, distribuidos aleatoriamente en dos grupos, Grupo Experimental (GE)(n=15) que recibió la TAB bilateralmente, y Grupo Control (GC) (n=15) que no recibió ninguna intervención. En ambos grupos se evaluaron (antes y después), la amplitud articular cervical, el UDP, los Puntos gatillo de Trapecios superiores y Escalenos anteriores (algómetría), y la intensidad del dolor en reposo y con cada movimiento cervical mediante una escala numérica del dolor (END). Resultados: El GE presenta mejoras estadísticamente significativas para las variables algométricas del trapecio superior derecho(p=0,033),trapecio superior izquierdo(p=0,03), la OM izquierda(p=0,003), el escaleno izquierdo(p=0,043), la amplitud de movimiento en rotación izquierda(p=0,04) y la intensidad del dolor a la rotación izquierda (p=0,013). Observamos tendencia a la significación estadística de la amplitud del movimiento de lateroflexión izquierda (p=0,056). Conclusiones: La técnica con arcos botantes para la abertura de la OM, aplicada en pacientes con CMC, aumenta el UDP en los músculol s trapecios, escaleno izquierdo y la sutura OM izquierda, la amplitud de movilidad y disminuye el dolor, durante la rotación cervical izquierda (AU)

Introduction: Mechanical neck pain (CM) could be considered a public health problem, affecting almost half of the population at some point in their lives. In 14% of the population, it has a duration of 6 months or more, causing labor limitations in activities of daily life and leisure. Objective: To analyze the immediate effects of the technique with flying buttresses (TFB) for the opening of the occipitomastoid (OM) suture, conducted bilaterally on the cervical joint extent, the pain pressure threshold (UDP) and the pain intensity. Material and methods: Experimental study, controlled, randomized, double-blind. Thirty (n = 30) subjects with CM, randomized into two groups: Experimental Group (GE) (n = 15) bilaterally received the TAB and Control Group (CG) (n = 15) that did not receive any intervention. In both groups, the cervical joint amplitude were evaluated (before and after), as well as the UDP, the trigger points of the higher trapezoids and anterior scalenes (algometry) and pain intensity at rest and with each cervical movement using a numerical pain scale (END). Results: The GE introduces significant improvements for algometrical variables of the right upper trapezius (p = 0.033), left upper trapezius (p = 0.03), the left OM (p = 0.003), the left scalene (p = 0.043), the range of motion in left rotation (p = 0.04) and pain intensity in left rotation (p = 0.013). We observed a trend towards statistical significance of the range of left sidebending (p = 0.056). Conclusions: The flying buttress technique for the opening of OM, applied in patients with CMC, increases the UDP in the trapezius muscles, left scalene and left OM suture, range of motion and decreases pain during left cervical rotation (AU)

Efectos de la terapia asistida con animales en personas con daño cerebral o lesión medular / Effects of animal assisted therapy in people with brain damage or spinal cord injury

Objetivo: Valorar los efectos terapéuticos obtenidos al aplicar un programa de terapia asistida con animales (TAA) en personas con daño cerebral o lesión medular. Material y método: Se realizó un estudio longitudinal prospectivo cuasi experimental en una población de 30 pacientes con diagnostico de daño cerebral o lesión medular. La selección se realizó mediante muestreo no probabilístico de conveniencia. Se dividieron en cinco grupos según criterios de edad. La duración del estudio fue de 16 meses, realizándose 23 sesiones de grupo, de 90 minutos de duración, durante los primeros nueve meses del estudio. Tres pacientes se perdieron durante el seguimiento. Para la evaluación se utilizó la Batería cognitiva LOTCA, el Índice de Barthel y la escala COPM. Resultados: En la valoración final, todos los pacientes mejoraron o se mantuvieron estables respecto a la valoración inicial. La evaluación COPM fue de 8,42±2,59 para la importancia, de 8,17±2,41 para el desempeño y de 8,96±2,07 en satisfacción. La valoración cognitiva mejoró en el 33% de los pacientes y la independencia funcional en el 37%. Conclusiones: La TAA puede servir como Técnica No Farmacológica (TNF) en los procesos de rehabilitación de las personas afectadas por patologías neurológicas (AU)

Objective: To evaluate the effects of animal assisted therapy (AAT) in a brain damaged or spinal injury population. Material and method: A prospective longitudinal study was undertaken on 30 patients with diagnosis of brain damage or spinal injury selected under non probabilistic accidental sampling, five groups were made according to patients age. A total of 23 sessions of AAT, 90 minutes long, were performed. Study period was 16 months, with therapy taking place in the first nine months. Three patients were lost in the follow up. Evaluation was performed using LOTCA cognitive battery test, Barthel index and COPM scale. Results: All patients showed improvement or no change according to initial evaluation. COPM evaluation were 8,42±2,59 for importance, 8,17±2,41 for performance, and 8,96±2,07 for satisfaction. Evaluation ranges from 1 to 10. Improvement was found in 33% of the patients for cognitive evaluation, and in 37% for functional independence evaluation showed improvement in most of the patients. Conclusion: AAT can be useful as non-pharmacological therapy in the rehabilitation process of neurological affected (AU)

Perfil de seguridad de las terapias biológicas intravenosas en una cohorte de pacientes con artritis reumatoide. Monitorización clínica por enfermería (estudio Sebiol) / Safety profile of biological intravenous therapy in a rheumatoid arthritis patients cohort. Clinical nursing monitoring (Sebiol study)

Introducción. El uso de biológicos ha permitido conocer de manera exhaustiva su seguridad gracias a registros como BIOBADASER. El presente trabajo permite, con un estudio observacional de cohortes, describir el perfil de seguridad perinfusional de dichos tratamientos por vía intravenosa. Objetivos. Conocer el perfil de seguridad en la práctica clínica, tras la administración de biológicos por vía intravenosa y durante las 24 h posteriores. Material y métodos. Cohorte transversal de 114 pacientes con AR tratados con agentes biológicos (criterios ACR) durante un mes de 2009 por enfermería de hospital de día de 12 centros hospitalarios catalanes. Se analizaron la edad, el sexo, los tratamientos actuales y previos, los datos de vacunación previa y la premedicación. Se registró también cualquier acontecimiento adverso (AA) durante la administración o en las 24 h posteriores. Se clasificó según el diccionario internacional MedDRAv11.0 y se describieron la intensidad (leve, moderada, severa), la relación con la administración del fármaco según el algoritmo de Karch y Lasagna (no relacionada, improbable, posible, probable, definitiva) y las medidas emprendidas. El análisis estadístico se realizó mediante SPSS 18.0. Resultados. Ciento once con criterios de inclusión (edad media ± desviación estándar 56,06 ± 12,12 años), 90 mujeres (81,1%) y evolución de 11,97 ± 7,95 años; 24 pacientes (21,6%) con antecedentes de alergia. Se observaron 12 AA en 7 pacientes, 9 de ellos durante la administración y 3 en las 24 h posteriores. No hubo ningún acontecimiento adverso grave y uno de los AA se calificó de intensidad moderada (urticaria). El resto de los AA fueron de intensidad leve (AU)

Introduction: The Biologics used in the management of rheumatoid arthritis (RA) in recent years, have comprehensively permitted to understand its security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments. Objectives: To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 hours post-administration. Material and methods: We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments, we also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 hours. If an adverse event occurred, was categorized by MedDRAv11.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken. Results: 111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 hours after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AA were mild (AU)

Experiencia preliminar en el tratamiento combinado de metástasis vertebrales mediante radiofrecuencia y cifoplastia en sesión única / No disponible

Objetivos: Describir nuestra experiencia preliminar en el tratamiento de metástasis vertebrales mediante radiofrecuencia y cifoplastia combinadas en sesión única. Material y métodos: Se trataron cuatro pacientes con metástasis vertebral única confirmada histológicamente (mama, próstata, pulmón y mieloma en D12, L1, L5 y D12, respectivamente). La indicación en todos los casos fue el dolor con una mala respuesta al tratamiento médico habitual. Todos los pacientes presentaban dolor en el rango 6-7 de la escala visual analógica (EVA). En dos casos existía lesión lítica del muro posterior. Tras la obtención del consentimiento informado se realizó el procedimiento bajo sedación e infiltración anestésica local. Se efectuó abordaje transpedicular bilateral con sistemas de punción ósea 11G. Se insertaron de forma coaxial dos agujas de radiofrecuencia para efectuar un ciclo de ablación por cada pedículo. Durante el ciclo de ablación la punta del dispositivo correspondiente se situó en la unión del tercio medio con el tercio anterior del cuerpo vertebral, empleando la segunda aguja como sensor térmico, con su extremo a la altura del muro posterior. La duración de cada ciclo de ablación fue de 8 minutos, alcanzando temperaturas intratumorales de 70-80 ºC. A continuación se realizó cifoplastia transpedicular. Resultados: No se registraron complicaciones intra-periprocedimiento, con alta domiciliaria en las 24 horas siguientes. En todos los pacientes hubo una mejoría inmediata del dolor tras el procedimiento (con dolor de intensidad 1-2 de la EVA). En tres pacientes se retiró progresivamente la medicación analgésica, sin evidencia en ninguno de ellos de progresión local de la enfermedad ni recurrencia-aumento del dolor en el seguimiento (dolor de intensidad 1 de la EVA en un seguimiento en el rango de 8-14 meses). En un paciente no se pudo efectuar seguimiento clínico-radiológico posterior al alta. Conclusión: El empleo de radiofrecuencia asociada a cifoplastia en la enfermedad metastásica vertebral puede contribuir al manejo del dolor refractario al tratamiento médico y al control local de la enfermedad (AU)

Objectives: Describe our preliminary experience in the treatment of vertebral metastases by radiofrequency and Kyphoplasty combined in one single session. Material and methods: Four patients with histologically confirmed single spinal metastasis (breast, prostate, lung and myeloma in L1, L5, D12, D12, respectively) were treated. The indication in all cases was pain with a poor response to medical treatment. All patients had pain in the range 6-7 visual analogue scale (VAS). In two cases there was a lytic lesion of the spinal posterior wall. After obtaining informed consent, and under sedation and local anesthetic the procedure took place. The transpedicular approach took place with a 11 G bone puncture system. Two radiofrequency needles were coaxially inserted to carry out an ablation cycle through each pedicle. During the ablation cycle the tip of the ablation neddle stood between the anterior and middle third of the vertebral body, while the second needle was used as thermal sensor with its end to the height of the vertebral posterior wall. The duration of each cycle of ablation was 8 minutes reaching intratumoral temperatures of 70-80 °C. Transpedicular Kyphoplasty was performed subsequently. Results: No complications were reported during or after the procedure and patients were discharged in the first 24 hours. There was an immediate improvement in pain after the procedure (with a VAS 1-2 intensity pain) in all patients. During follow up, analgesic medication was withdrawn in three patients, and there was no evidence of disease progression or recurrence of pain (pain intensity 1 (VAS) in a follow-up in the range of 8-14 months). Clinical and radiological follow-up after discharge could not be performed on a patient. Conclusion: The use of radio-frequency associated with Kyphoplasty in vertebral metastatic disease can contribute to the management of refractory pain to medical treatment (AU)

Uso del parche de capsaicina 8 por ciento para el tratamiento del dolor por infusión de treprostinil subcutáneo / No dispoinible

Introducción: la HP (hipertensión pulmonar) es una enfermedad poco prevalente (15 casos por 1 millón de habitantes), pero se trata de un proceso grave con una mortalidad muy elevada. El tratamiento se hace con treprostinil administrado por vía subcutánea. El principal efecto secundario que presenta es dolor e inflamación en el punto de infusión, obligando en muchos casos a la retirada del tratamiento. Presentamos un caso clínico de un paciente de 46 años diagnosticado de hipertensión pulmonar secundaria a VIH, que acude en tratamiento con treprostinil subcutáneo y que refirió intenso dolor en la zona de punción (zona abdominal periumbilical) los primeros días (4-5) de la infusión, con una intensidad muy severa (VAS 9-10) que le obligó a estar encamado. Planteamos la posibilidad de tratamiento con parche de capsaicina 8% (Qutenza®) de forma experimental, indicando al paciente su uso fuera de ficha técnica (off-label) y firmando el consentimiento informado. Se realiza tratamiento previo durante una hora con crema EMLA, según protocolo, se delimita la zona abdominal periumbilical (lugar de punción) y se administra parche durante una hora. Se observa posteriormente eritema en la zona de administración, sin más incidencia. Buena tolerancia del tratamiento y alta a domicilio. No existen publicaciones actualmente que hayan estudiado el uso de parche de capsaicina para tratar el dolor relacionado con la infusión de treprostinil s.c., por ello consideramos relevante la experiencia de este caso clínico. De este modo, creemos que, aunque pendiente de la validación por ensayos clínicos, el tratamiento con parches de capsaicina 8% (Qutenza®) podría ser una alternativa válida a tener en cuenta en el control analgésico de los pacientes en tratamiento con treprostinil s.c., logrando de este modo la adherencia a dicho tratamiento y que más pacientes puedan beneficiarse de teprsotinil para el tratamiento de la HP (AU)

Background: PH (Pulmonary Hypertension) is a low prevalence disease (15 cases per 1 million inhabitants), but is nevertheless a serious process with high mortality. Treprostinil is a new drug for the PH treatment, it is a prostacyclin with a half-life of 2-3 hours, which permits subcutaneous administration with rapid absorption and 100% bioavailability. The issue with treprostini is the high rate of drop-outs due to pain at the injection site. Aims: to reduce the rate of drop-outs due to pain at the injection site with the use of Treprostinil Methods: we searches in PubMed and Tripdatabase, fore terms, "capsaicin", "qutenza", "treprostinil", and "pulmonary hypertension", finding no related publication. The treatment with capsaicin 8% patch, was performed for one hour, according to the protocol, the peri-umbilical abdominal area (injection site) was delimited and the patch administered for one hour. Resul ts: erythema at the administration site was subsequently observed, albeit with no further incidents. Good treatment tolerance and discharge. In the control after 1 month, the patient reported changing the injection site to the treated area with a very striking reduction in pain (VAS 2-3) that enabled him to lead a normal life. The patient's satisfaction is very high, and he requires no coadjuvant or rescue treatment. At the 3-month control, the patient continues with the same level of analgesia Conclusions: capsaicin 8% patch could be a valid alternative to be considered in the analgesic control of patients on treatment with subcutaneous treprostinil (AU)

Group recruitment sessions enhance patient understanding in a small multi-centre phase III clinical trial.

INTRODUCTION: There is continuing concern that patient information leaflets, tailored to current regulatory requirements, fail to meet patients' needs. Provision of comprehensible information is vital if patients are to provide valid informed consent. The design of the ARIX (acupuncture for radiation induced xerostomia) trial provided an opportunity to deliver researcher led, enhanced patient information to groups of potential participants. METHODS: Between November 2009 and September 2010, 149 patients attended a trial introduction meeting at their local site. All meetings followed the same format. The study coordinator delivered a PowerPoint presentation containing standard trial information together with customised local details. This was followed by group questions and answers. Patients could sign a consent form immediately afterwards or with local staff at a later date. Participants who completed the study were invited to feedback their views on these meetings. RESULTS: One hundred and forty nine patients attended a meeting of whom 116 ultimately participated in ARIX and provided feedback. Eighty four (72%) reported that the meeting helped their understanding of the trial 'very much'. Fourteen attendees reported feeling uncomfortable at having the information presented in a group setting but of these, only one felt under pressure to join the trial. Eighty three patients (71%) felt 'not at all' uncomfortable and 111 (95%) 'not at all' under pressure to participate. CONCLUSION: Trial introduction meetings involving researcher led presentation of information, followed by group discussion, can help enhance the information provided in the patient information leaflet in a useful and non coercive manner.

Recuperación funcional tras fractura de cadera en una población anciana, medida con el índice de Barthel / Use of the Barthel Index to measure functional recovery in an elderly population after hip fracture

Objetivo. Analizar el grado de recuperación funcional de una serie de pacientes afectados de una fractura de cadera (FC),a los 6 y 12 meses tras la fractura, usando el índice de Barthel (IB) como instrumento de medida. Material y métodos. Estudio longitudinal prospectivo no intervencionista sobre 246 pacientes mayores de 65 años que acudieron a nuestro centro tras sufrir una FC por un traumatismo de baja energía. Se determinó su edad, sexo, nivel socioeconómico, grado de independencia funcional (IB) tanto previo como a los 6 y 12 meses, y su destino al alta (domicilio, residencia privada o un hospital de crónicos concertado con la consejería) y su mortalidad a los 6 y 12 meses. Resultados. Las mujeres constituyeron el 71,5% de los casos con una edad media de 81 años. El IB medio previo a la FC fue de 77 puntos. El 70% de los pacientes deambulaban antes de la fractura. De éstos, sólo el 48% que sufrió una FC intracapsular y el 39% de los que sufrieron una FC extracapsular volvieron a caminar a la finalización del estudio (12 meses). En 35 pacientes se desestimó el tratamiento quirúrgico por causas médicas o negativa familiar. Conclusiones. Los pacientes con edad extrema, demencia, bajos niveles de formación académica, institucionalizados en centros de crónicos y no operados presentaron peor IB a los 6 y 12 meses. El estado neurológico aceptable, acudir a control en la consulta externa, el cuidado familiar y unos niveles altos de hemoglobina preoperatoria se han relacionado con una mejor la recuperación funcional en estos pacientes (AU)

Purpose. To determine how many patients were able to return to their previous independence status after a hip fracture, using the Barthel Index Scale to measure it. Materials and methods. An observational, prospective longitudinal study of 246 patients over 65 diagnosed with hip fracture. We determined age, sex, type of fracture and treatment, cultural, and economical status, independence level before and after the fracture, and mortality over 12 months. Results. Of the 246 patients studied, 71.5% were women, and the mean age was 81 years. The Barthel Index Scale before the fracture was 77. Seventy per cent of the patients were capable of walking before the fracture, but only 48% with intracapsular, and 39% with extracapsular hip fracture, reached their previous walking capability. Thirty five patients underwent nonsurgical treatment. Conclusions. We found that advanced age, dementia, lower education levels, residence-dependent patients, and those who did not have surgical treatment, had lower levels on the Barthel Index Scale at 6 and 12 months. On the other hand, the absence of neurological diseases, attending follow-up clinics, good family care, and high haemoglobin levels prior to the fracture seemed to lead to a better functional recovery (AU)

Evaluation of limitation-of-medical-treatment forms used in emergency medicine residency programs in the United States.

BACKGROUND: Patients are encouraged to complete limitation-of-medical-treatment forms (LMTFs), sometimes referred to as code status forms or do-not-resuscitate forms, before admission to hospitals or other health care facilities in the United States. OBJECTIVE: The purpose of this study was to review, evaluate, and to assess the LMTFs currently used in emergency medicine residency training programs throughout the United States. METHODS: In February 2009, researchers sent letters to all allopathic and osteopathic emergency medicine residency program directors (n = 193) requesting a copy of the LMTF used in their hospital. These forms were evaluated for content, consistency, and readability. RESULTS: Sixty-five responses were received (corrected response rate = 34%); 45 LMTFs were reviewed. Nineteen LMTFs required the signature of the patient, or the patient's appointed durable power of attorney for health care. The readability ranged from 11th to 17th grade (mean ± SD = 13.16 ± 1.77), greatly exceeding the average Americans' 8(th)-grade reading level. CONCLUSIONS: Our findings demonstrate that there is no standardization across LMTFs currently used in hospitals throughout the United States, and these forms are written above the literacy level of the average American adult. Therefore, there is a need to develop and disseminate an LMTF that is both consistent and better understood by the average American adult.

[AIDS: ethics and scientific investigation on human beings]. / Sida: éthique et investigation scientifique sur l'être humain.

The experimentation on human beings of one or several therapeutic molecules discovered in laboratory is necessary and important because it helps to find new treatments or new diagnostic methods. But, it presents serious ethical problems. In this article we are analysing the example of the HIV infection. We are succinctly describing the research methods in laboratory for therapeutic molecules, first the experimentation on animals and then on human being in clinical trials. We will then try to show, with several examples, how during these last 25 years of HIV infection, the research of new molecules has not always respected the ethical rules set out in Helsinki declaration, "Code de la santé publique" or "Guide de bonnes pratiques cliniques-ICH" etc. We are discussing here the way to avoid these irregularities.

Patients' predilections regarding informed consent for hospital treatments.

BACKGROUND: Respect for patient autonomy is a core principle of American medicine. Informed consent is required for surgical procedures and blood transfusions but not for most medical treatments of hospitalized patients. HYPOTHESIS: If given the option, patients want to give permission for common medical therapies during hospitalization. SUBJECTS: Participants in the study were patients admitted to the medical service of a 350-bed community teaching hospital. METHODS: A questionnaire comprising 4 scenarios of varying risk/benefit ratios was administered to all patients who agreed to participate. RESULTS: A total of 634 patients were admitted to the medicine service between June and August 2006. Two hundred and ten patients (103 men, 107 women), with a mean age (+/- SE) of 63.3 +/- 1.1 years, agreed to answer the questionnaire. Of these patients, 85% wished to participate in even trivial medical decision making (ie, potassium supplementation), 92% wished to participate in treatments with moderate risk (ie, diuretic for congestive heart failure). When a risk was initially posed as less than a 5% risk of brain hemorrhage and benefits of therapy were substantially higher (eg, thrombolysis for pulmonary embolus), 93% wanted to make the decision. If the risk of brain hemorrhage was 20% or greater, 95% wanted to make the decision. Younger patients (<65 years) were more likely to prefer requiring doctors to obtain their "permission no matter what" than were older patients (>or=65 years), and older patients were more likely to waive consent across levels of risk. CONCLUSIONS: Most acutely ill hospitalized medicine patients wished to participate in even the most mundane aspects of their medical decision making. Although it is not logistically feasible to obtain informed consent for every treatment of every hospitalized patient, clinicians should be aware of patients' predilections and might consider offering opportunities for patients to participate in clinical decision making, especially for therapies that carry substantial risk.

Clinical trials in pediatric traumatic brain injury: unique challenges and potential responses.

In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.