Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial.

The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. METHODS: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. RESULTS: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. CONCLUSIONS: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.

Cribado nutricional en pacientes quirúrgicos en un hospital universitario / Nutritional screening in surgical patients at a university hospital

Objetivo: conocer la prevalencia de riesgo de desnutrición de los pacientes quirúrgicos hospitalizados de un hospital de tercer nivel. Método: estudio descriptivo transversal unicéntrico con pacientes quirúrgicos hospitalizados. Se realizó un cálculo de tamaño muestral de 323 pacientes y se reclutaron por conveniencia. Se analizó el riesgo de desnutrición con la escala Nutrition Risk Screening 2002 y su asociación con diferentes variables sociodemográficas y clínicas. Para el análisis de datos se aplicaron las pruebas de Chi cuadrado, prueba exacta de Fisher, t de Student y U de Mann Whitney con una significancia estadística de p< 0,05. Resultados: participaron 318 pacientes, de los cuales el 74,8% era hombre, con una edad media de 62,2 años (DE: 15,54). En el cribado inicial, 80 participantes (25,2%) presentaron riesgo potencial de desnutrición mientras que tras el screening final, solo 12 presentaron riesgo de desnutrición real (3,8%). No se halló relación entre la desnutrición y el sexo aunque sí con la edad, aumentando el riesgo proporcionalmente (p< 0,001). Otros factores asociados fueron la necesidad de un cuidador/a (p= 0,001), el tipo de patología de ingreso (p= 0,034) y tener antecedentes personales oncológicos (p< 0,001) y de deterioro cognitivo (p= 0,001). Conclusiones: la prevalencia de desnutrición en pacientes quirúrgicos hospitalizados es baja y parece que aumenta con la edad, y con antecedentes personales de deterioro cognitivo y enfermedad neoplásica, aunque los resultados deben ser interpretados con cautela. Identificar la presencia de desnutrición al ingreso favorece el fomento de medidas de prevención que permitan implementar un plan nutricional y facilitar el seguimiento tras el alta.(AU)

Objectives: to understand the prevalence of the risk of malnutrition among hospitalized surgical patients in a tertiary hospital. Method: a descriptive cross-sectional single-centre study with hospitalized surgical patients. The sample size was calculated at 323 patients, and there was convenience recruitment. The malnutrition risk was analysed with the Nutrition Risk Screening 2002 scale, and its association with different sociodemographic and clinical variables. The Chi Square, Fisher’s Exact, Student’s t and Mann-Whitney tests were applied for data analysis, with a statistical significance of p< 0.05. Results: the study included 318 patients; 74.8% of them were male, with a mean age of 62.2 years (SD: 15.54). At the initial screening, 80 participants (25.2%) presented potential risk of malnutrition; while after the final screening, only 12 presented a real risk of malnutrition (3.8%). No relationship was found between malnutrition and gender, but it was found with age, with a proportional increase in risk (p< 0.001). Other factors associated were the need for a caregiver (p= 0.001), the type of condition at admission (p= 0.034) and having a personal background of neoplasia (p< 0.001) and cognitive deterioration (p= 0.001). Conclusions: there is a low prevalence of malnutrition among hospitalized surgical patients, and it seems to increase with age and with a personal history of cognitive deterioration and neoplasia, although these results must be interpreted with caution. The detection of malnutrition at admission will promote taking prevention measures, therefore allowing to implement a nutritional plan and facilitating follow-up after discharge.(AU)

Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial.

BACKGROUND: Surgical wounds are covered to prevent bleeding, absorb the exudates, and provide a barrier against external contamination. Currently, in our hospital, after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. Some of the newest dressings have been shown to reduce the incidence of blisters compared with traditional dressing or colloid adhesive dressings. However, there are no comparative evaluations between the different types of dressings and their contribution to the overall results of the healing process. METHODS/DESIGN: This is a randomized, controlled, open-label trial to compare five types of dressings used in total knee and hip arthroplasty surgical wounds. A total of 550 patients will be randomly allocated to one of the following dressings: (1) traditional occlusive dressing, (2) Aquacel Surgical®, (3) Mepilex® Border Post-Op, (4) OpSite Post-Op Visible, or (5) UrgoTul® Absorb Border. The dressing assigned is placed right after surgery. Patients will be followed up to 14 days after surgery when the dressing is definitively removed and will be tracked up to 3 months to record any late complications. During the immediate postoperative period and patient hospitalization and at the ambulatory visits after discharge, every time that the dressing is changed, nurses perform the study assessments. The main study outcome will be the percentage of patients with skin integrity at all times when the dressing has been changed. Skin integrity is a composite of the absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates. Secondary outcomes include time to first change of dressing; percentage of patients with presence/absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates; number of dressing changes needed; days of hospital stay; and nurse and patient satisfaction. Differences in the main variable between each treatment group and group 1 will be tested by means of a chi-squared test or Fisher's exact test. Subgroup analyses of diabetic and non-diabetic patients, patients with a body mass index of more than 30 or not more than 30, and type of surgery (hip or knee) are planned. DISCUSSION: The results of this study will be useful for clinical decision making by giving information on the contribution of the dressings studied to the outcome of the wound and may also show which dressing offers better results depending on the characteristics of patients. TRIAL REGISTRATION: This trial has been registered at ClinicalTrials.gov ( NCT03190447 ). Retrospectively registered on 16 June 2017.