Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service.

BACKGROUND AND PURPOSE: Clinical trials (CTs) aimed at vulnerable groups, such as patients with mental disorders, create ethical complexity. The patient information sheet (PIS) should provide all of the information about the CT that is relevant to the subject's decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the informed consent form (ICF). The objective was to assess the quality of PISs/ICFs from a hospital neurology service. The assessment was made using validated and reliable checklists of the information included in the PISs/ICFs of CTs with medicinal products. METHODS: The study comprised analyses of compliance with the checklists of 21 PISs and ICFs reviewed/approved during 2016-2017 by a medicinal research ethics committee. RESULTS: All PISs/ICFs were from multicenter CTs sponsored by pharmaceutical companies in different therapeutic areas, mainly Parkinson's (52.4%) and Alzheimer's (38.1%) diseases. The PISs from the neurology service demonstrated good compliance (≥80%) with the checklist, whereas ICFs should be improved. Sponsors omitted some relevant information, such as the study title or that the participant be informed of any information arising from the research that may be relevant to the subject's health, although this information may be in the PIS. CONCLUSIONS: The PISs/ICFs of CTs of medicinal products that are currently used need improvement. PISs and ICFs should be separate documents for each CT. In particular, the PISs/ICFs should consider the criteria related to the decision of participants, protect their rights and ensure that the information received is complete.

[Enteral supplements: dietary supplements or substitutes?]. / Suplementos enterales, complementos o sustitutos de la dieta?

OBJECTIVE: To assess the use of oral nutritional supplements analyzing the reason for prescription and its implication in caloric-protein intake. SETTING: study performed at a university hospital of 350 beds with medical and surgical specialties. SUBJECTS, PATIENTS: Patients inclusion was done by selecting all starting oral nutritional supplement prescription. Exclusion criteria were being younger than 18 years, being admitted to the Intensive Care Unit, having cognition or communication impairments, being on concomitant parenteral nutrition or requiring complete enteral diet, and/or using nasogastric tube for feeding. We also excluded special enteral diets, specifically designed for certain conditions. INTERVENTIONS: One-year long prospective study on prescription of oral nutritional supplements. Through clinical chart review and personal interview, we recorded demographic data, nutritional parameters, characteristics of the diet and supplement, and caloricprotein intake prescribed and ingested. The data were introduced in an Access97 database and processed by means of SPSS software for Windows. We performed a descriptive study of quantitative and qualitative variables, a chi2 analysis between qualitative variables, and a comparative analysis between means of all paired data by means of the student's t test, and variance analysis between quantitative variables. The significance level was set at p < 0.05. RESULTS: we were only able to analyze 77 out of 130 prescriptions for nutritional supplements since we could not adequately interview the remaining patients, mainly due to neurological impairments. Mean age was 74.8 years (SD = 12) and 50.6% were women. The departments prescribing the highest number of supplements were hematology (22.1%) and internal medicine (20.8%). GI neoplasm was the most frequent diagnosis at admission (27.3%). The most frequent indication was kwashiorkor (45.5%), with 15.6% of patients being well nourished. Mean therapy duration was 11 days (SD = 11.1), and the main reason for termination was hospital discharge (70.1%). The supplement was concomitantly prescribed with the meals in 70.6% of the cases, and more than half of the patients (70.1%) liked it, the most frequently prescribed was as a cream (61%) and the best accepted being as a liquid (78%). The average daily caloric load ingested with the foods of the hospital diet was similar between the first an third days of supplement prescription (p = 0.879) and the first and seventh days (p = 0.499). So happened when analyzing protein intake. With the supplement administration, there was a significant increase in patients' caloric intake from 310 Kcal at the third day to 337 Kcal at the seventh day (p < 0.0005) in both cases. Similar results were obtained when assessing total protein load ingested (p < 0.0005). CONCLUSIONS: Nutritional supplements are correctly used in most of the cases. They allow for a significant increase in the protein-caloric intake with no modification of hospital diet, becoming an appropriate nutritional source when the diet is insufficient.

Suplementos enterales, ¿complementos o sustitutos de la dieta? / Enteral supplements: dietary supplements or substitutes?

Objetivo: Evaluar la utilización de suplementos nutricionales orales analizando el motivo de su prescripción y su implicación en el aporte calórico-proteico ingerido. Ámbito: Estudio realizado en un hospital universitario de 350 camas, que dispone de especialidades médicas y quirúrgicas. Sujetos, pacientes: La inclusión de pacientes se realizó mediante selección de todas las prescripciones de inicio de suplemento nutricional oral. Los criterios de exclusión fueron ser menor de 18 años, estar ingresado en la Unidad de Cuidados Intensivos, presentar problemas cognitivos o de comunicación, seguir tratamiento concomitante con nutrición parenteral o precisar dieta enteral completa, y/o ser portador de sonda nasogástrica para alimentación. También se excluyeron las dietas enterales especiales, que están diseñadas específicamente para algunas patologías. Intervenciones: Estudio longitudinal y prospectivo de la prescripción de suplementos nutricionales por vía oral realizado durante un año. Mediante revisión de la historia clínica y entrevista personalizada, se registraron datos demográficos, parámetros nutricionales, características de la dieta y del suplemento, y aporte calórico-proteico prescrito e ingerido. Los datos fueron introducidos en una base de datos Access 97 y procesados mediante el programa SPSS para Windows. Se realizó un estudio descriptivo de las variables cualitativas y cuantitativas, un análisis de χ2 entre variables cualitativas, un análisis de comparación de medias para datos apareados mediante una t Student y un análisis de la varianza entre variables cuantitativas. El nivel de significación establecido fue p < 0,05. Resultados: De 130 prescripciones de suplemento nutricional, se analizaron 77 por la imposibilidad de entrevistar correctamente al resto de pacientes, principalmente por motivos neurológicos. El promedio de edad fue de 74,8 años (DE = 12) y el 50,6% eran mujeres. Los servicios que prescribieron mayor número de suplementos fueron hematología (22,1%) y medicina interna (20,8%).La neoplasia digestiva fue el diagnóstico de ingreso más frecuente (27,3%). La indicación mayoritaria fue el kwashiorkor (45,5%), observándose un 15,6% de pacientes no malnutridos. La duración media del tratamiento fue de 11 días (DE = 11,1) y el principal motivo de fin, el alta hospitalaria (70,1%). El suplemento se prescribió concomitante con las comidas en el 70,6% de los casos y gustó a más de la mitad de los pacientes (70,1%), siendo el de tipo crema el más prescrito (61%) y el líquido el mejor aceptado (78%). El promedio del aporte calórico diario ingerido con los alimentos de la dieta hospitalaria fue similar entre el día de la prescripción del suplemento y el tercer día (p = 0,879), así como entre el primero y el séptimo (p = 0,499). De forma parecida sucedía al valorar la ingesta proteica. Con la administración del suplemento, se produjo un aumento significativo en la ingesta del paciente de 310 kcal a los 3 días y de 337 kcal a la semana (p < 0,0005 en ambos casos).Resultados similares se obtuvieron en la valoración del aporte proteico total ingerido (p < 0,0005). Conclusiones: Los suplementos nutricionales se utilizan correctamente en la mayoría de los casos. Permiten aumentar significativamente el aporte calórico-proteico ingerido, no modificando la ingesta de la dieta hospitalaria, pudiendo ser una fuente nutricional apropiada que complemente a la dieta cuando ésta resulta insuficiente (AU)

Objective: to assess the use of oral nutritional supplements analyzing the reason for prescription and its implication in caloric-protein intake. Setting: study performed at a university hospital of 350 beds with medical and surgical specialties. Subjects, patients: Patients inclusion was done by selecting all starting oral nutritional supplement prescription.Exclusion criteria were being younger than 18 years, being admitted to the Intensive Care Unit, having cognition or communication impairments, being on concomitant parenteral nutrition or requiring complete enteral diet, and/or using nasogastric tube for feeding. We also excluded special enteral diets, specifically designed for certain conditions. Interventions: One-year long prospective study on prescription of oral nutritional supplements. Through clinical chart review and personal interview, we recorded demographic data, nutritional parameters, characteristics of the diet and supplement, and caloricprotein intake prescribed and ingested. The data were introduced in an Access 97 database and processed by means of SPSS software for Windows®.We performed a descriptive study of quantitative and qualitative variables, a χ2 analysis between qualitative variables, and a comparative analysis between means of all paired data by means of the student´s t test, and variance analysis between quantitative variables. The significance level was set at p < 0.05. Results: we were only able to analyze 77 out of 130 prescriptions for nutritional supplements since we could not adequately interview the remaining patients, mainly due to neurological impairments. Mean age was 74.8 years (SD = 12) and 50.6% were women. The departments prescribing the highest number of supplements were hematology (22.1%) and internal medicine (20.8%). GI neoplasm was the most frequent diagnosis at admission (27.3%). The most frequent indication was kwashiorkor (45.5%), with 15.6% of patients being well nourished.Mean therapy duration was 11 days (SD = 11.1), and the main reason for termination was hospital discharge (70.1%). The supplement was concomitantly prescribed with the meals in 70.6% of the cases, and more than half of the patients (70.1%) liked it, the most frequently prescribed was as a cream (61%) and the best accepted being as a liquid (78%). The average daily caloric load ingested with the foods of the hospital diet was similar between the first an third days of supplement prescription (p =0.879) and the first and seventh days (p = 0.499). So happened when analyzing protein intake. With the supplement administration, there was a significant increase in patients´ caloric intake from 310 Kcal at the third day to 337 Kcal at the seventh day (p < 0.0005) in both cases. Similar results were obtained when assessing total protein load ingested (p < 0.0005). Conclusions: Nutritional supplements are correctly used in most of the cases. They allow for a significant increase in the protein-caloric intake with no modification of hospital diet, becoming an appropriate nutritional source when the diet is insufficient (AU)

[Protocols implementing in a university hospital. An assessment of various methods]. / Implantación de protocolos en un hospital universitario. Evaluación de diferentes métodos.

OBJECTIVE: To establish a method for evaluating, in a systematic and periodic way, the degree of compliance with the protocols currently being used in the hospital. MATERIALS AND METHOD: Experts from the hospital designed 6 protocols which were later approved by consensus by several committees and agreed by Medical Direction. The doctors were informed of the new protocols by means of info-sessions and printed materials. In order to evaluate to what extent the protocols were complied with, we carried out a number of longitudinal and cross-sectional studies depending on how often the protocols are used. RESULTS: The study involved 2,190 patients. Cross-sectional studies. Surgical antimicrobial prophylaxis protocol: compliance with the application forms was 83.3% and for surgical interventions it was 64.3%. It should be noted that adherence improved with time. Sliding-scale insulin therapy: compliance improved during the observation period from 54 to 71.1%. Prevention of NSAID induced gastropathy: after 6 months a significant improvement was observed in relation to the previous phase. Pain treatment: of the 117 analgesics prescribed on-demand in the previous phase, 27.3% were administered, as well as 68.4% of a total of 95 fixed prescriptions. In the phases previous to setting up these protocols, adherence ranged from 0 to 68.4%. One year later, adhesion has improved significantly for all the evaluated protocols. Longitudinal studies. Community acquired pneumonia: adhesion was 60.8%, while non significant differences were observed according to severity. Transitory ischemic accident: compliance evaluation showed an adherence value of 81.8%. CONCLUSIONS: When the degree of compliance is high, follow-up studies may be spaced out in time. If not, the reasons for this low compliance must be identified and measures must be taken. Follow-up studies must be carried out more often when protocols have just been set up and less frequently as adherence improves.

[Diarrhea and enteral nutrition]. / Diarrea y nutrición enteral.

The present study is a review of what is understood by diarrhoea and the factors leading to its development in patients on enteral nutrition. An analysis is made of the factors related to the preparation, administration and the factors concerning the patient. It has been observed that there are important discrepancies in the evaluation of diarrhoea provoked by enteral diets. This is due to the different definitions of diarrhoea, the method used and exclusion criteria used by different authors.

[Updated study of enteral nutritional diets sold in Spain]. / Estudio actualizado de las dietas de nutrición enteral comercializadas en España.

Due to the large number of enteral nutrition diets on the market in Spain, it is difficult to collect together all the information on the subject. This study sets out the criteria recommended by the Hospital of Alabama and the University of Birmingham in the evaluation of the information furnished by the laboratories that prepare the enteral nutrition diets. The study includes a compendium of the data provided by these laboratories with a view to simplifying the electron of the preparations.