Background POSITIVE (i.e. maintaining and imPrOving the intrinSIc capaciTy Involving primary care and caregiVErs) is a new intervention program consisting of home-monitoring equipment and a communication platform to support treatment of frailty symptoms initially in primary care and prevent disability in older adults. Methods The primary objectives are to estimate the potential efficacy of the POSITIVE system on improving frailty in at least one point in Fried’s criteria and five points in Frailty Trait Scale. The secondary objectives are to (A) assess the recruitment, retention, drop-out rates, compliance with the intervention and the intervention mechanisms of impact; (B) evaluate the usability and acceptance of the POSITIVE system, and to get estimations on; (C) the potential efficacy of the intervention on improving the participants’ physical performance, cognitive functions, mood, independency level in activities in daily living, the impact on quality of life and number of falls during the follow-up period; (D) the impact on the caregiver quality of life and caregiver burden; and (E) on the consumption of health care resources, participants’ perception of health and level of care received, and healthcare professionals’ workload and satisfaction. A randomised controlled, assessor-blinded pilot study design recruiting from a primary care centre in Stockholm Region will be conducted. Fifty older adults identified as pre-frail or frail will be randomised into a control or an intervention group. Both groups will receive a medical review, nutritional recommendations and Vivifrail physical exercise program. The intervention group will receive the POSITIVE-system including a tablet, the POSITIVE application and portable measurement devices. The participants receiving the POSITIVE program will be monitored remotely by a primary care nurse during a 6-month follow-up. Data will be collected at baseline, 3 and 6 months into the intervention though the platform, standardised assessments and surveys. A process evaluation as per Medical Research Council guidance will be conducted after the 6-month follow-up period. Discussion The implications of the study are to provide estimations on the potential efficacy of the POSITIVE system in improving frailty among older adults and to provide relevant data to inform powered studies of potential efficacy and effectiveness, as well as to inform about the feasibility of the current study design. Trial registration ClinicalTrials.gov. Registration number: NCT04592146. October 19, 2020.

Objetivo: Evaluar la calidad de los formatos de consentimiento médico informado para cirugía mayor utilizados en los diferentes servicios de los hospitales de nivel III–IV de Lima y Callao. Material y métodos: Estudio descriptivo, cualitativo y transversal. Obtenidos los formatos de consentimiento médico informado para cirugía mayor utilizados en los servicios de los hospitales de nivel III – IV del Lima y Callao; se evaluó su calidad contrastándolos con una plantilla de requisitos elaborada con base en la literatura. Resultados: De los 28 formatos de consentimiento médico informado para cirugía mayor de 20 hospitales de nivel III–IV en Lima y Callao evaluados, 14,2% cumplían con más del 75% de los requisitos; 57,2%, con 75-50%; y 28,6%, con menos del 50%. Los requisitos acerca del procedimiento y sus características estuvieron ausentes en más del 75% de los formatos. Los formatos de los hospitales pertenecientes al Ministerio de Salud (MINSA) cumplieron en promedio con 12 requisitos (rango 4-21); los de las Fuerzas Armadas (FFAA), con 17 (rango 14-18); y los del EsSALUD, con 18 (rango16-22). Conclusiones: Los formatos de CMI de los servicios de los hospitales de nivel III–IV de Lima Callao evaluados no presentan uniformidad entre ellos y no garantizan que el paciente ha sido completa y correctamente informado ni que se ha respetado su autonomía en la toma de decisión. Los formatos de CMI del MINSA fueron los más deficientes y los que presentaron mayor variabilidad de calidad. Se propone un modelo de CMI para ser tomado como base por los diferentes servicios de hospitales para la elaboración de futuros CMI.

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