Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Dejar de hacer lo que no aporta valor en la Era COVID-19 / No disponible

No disponible

El impacto que tienen los eventos adversos sobre los profesionales sanitarios de atención primaria y sus instituciones / The impact of adverse events on health primary care professionals and institutions

No disponible

Laringectomía horizontal supraglótica láser CO2: nuestra experiencia en seis años / CO2 laser surgery of supraglottic carcinoma: Our experience over 6 years

Introducción y objetivos: El objetivo del estudio es analizar los resultados oncológicos y funcionales de la microcirugía láser en el tratamiento del carcinoma supraglótico de laringe. Material y métodos: Cincuenta y tres pacientes fueron incluidos en este estudio retrospectivo entre el año 2000 y 2006. El periodo de seguimiento fue superior a 2 años y la media fue de 49 meses. Resultados: La extensión tumoral fue T1 en 12 pacientes (22,6%), T2 en 37 (69,8%) y T3 en 4 pacientes (7,5%). En 47 pacientes (88,7%) se realizaron vaciamientos cervicales ganglionares. Diecinueve pacientes (35,8%) recibieron radioterapia (RT) postoperatoria. Las estimaciones de la supervivencia causa-específica con el método de Kaplan-Meier fueron de 80%, 74,11% y 65% a los 2, 3 y 5 años, respectivamente. La preservación de la función laríngea fue posible en el 90,56% (48 de 53) y el control local fue del 81,13%. Durante el periodo de seguimiento 13,2% de los pacientes desarrollaron recidiva local, 11,3% recidiva regional y 5,7% recidiva locorregional. Los pacientes comenzaron a deglutir de forma temprana tras la cirugía con un tiempo medio de 5,83 días y la estancia media hospitalaria fue de 14,69 días. El 20,75% sufrieron neumonía y el 11,32% hemorragia. Únicamente un paciente (1,88%) precisó una laringectomía total por imposibilidad para la deglución. Conclusiones: Con una selección cuidadosa de pacientes, la laringectomia supraglótica con láser es un tratamiento seguro y efectivo para el cáncer supraglótico de laringe (AU)

Introduction and objetives: The study goal was to analyze the oncologic and functional outcomes of transoral laser microsurgery in the treatment of carcinoma of the supraglottic larynx. Material and methods: A total of 53 patients were included in this retrospective review between 2000 and 2006. The follow-up period was more than 2 years and the mean follow-up for all patients was 49 months. Results: Tumour extension was as follows: T1 in 12 (22.6%), T2 in 37 (69.8%) and T3 in 4 (7.5%). Forty-seven patients (88.7%) had neck dissections. Nineteen patients (35.8%) received adjuvant radiotherapy. Kaplan-Meier estimates for disease-specific survival were 80%, 74.11% and 65%, at 2, 3 and 5 years, respectively. The overall functional laryngeal preservation rate was 90.56%. (48 of 53), and local control 81.13%. During follow up, 13.2% of patients developed local recurrence, 11.3% regional recurrence and 5.7% loco-regional recurrence. Patients started swallowing early after surgery, with a mean time of 5.83 days, and the mean hospital stay was 14.69 days. Complications included 20.75% who suffered pneumonia and 11.32% with bleeding. Only one patient (1.88%) received total laryngectomy due to the impossibility of swallowing. Conclusions: With careful selection of patients, laser supraglottic laryngectomy is a safe and effective treatment for cancer of the supraglottic larynx (AU)

CO2 laser surgery of supraglottic carcinoma: our experience over 6 years.

INTRODUCTION AND OBJECTIVES: The study goal was to analyze the oncologic and functional outcomes of transoral laser microsurgery in the treatment of carcinoma of the supraglottic larynx. MATERIAL AND METHODS: A total of 53 patients were included in this retrospective review between 2000 and 2006. The follow-up period was more than 2 years and the mean follow-up for all patients was 49 months. RESULTS: Tumour extension was as follows: T1 in 12 (22.6%), T2 in 37 (69.8%) and T3 in 4 (7.5%). Forty-seven patients (88.7%) had neck dissections. Nineteen patients (35.8%) received adjuvant radiotherapy. Kaplan-Meier estimates for disease-specific survival were 80%, 74.11% and 65%, at 2, 3 and 5 years, respectively. The overall functional laryngeal preservation rate was 90.56%. (48 of 53), and local control 81.13%. During follow up, 13.2% of patients developed local recurrence, 11.3% regional recurrence and 5.7% loco-regional recurrence. Patients started swallowing early after surgery, with a mean time of 5.83 days, and the mean hospital stay was 14.69 days. Complications included 20.75% who suffered pneumonia and 11.32% with bleeding. Only one patient (1.88%) received total laryngectomy due to the impossibility of swallowing. CONCLUSIONS: With careful selection of patients, laser supraglottic laryngectomy is a safe and effective treatment for cancer of the supraglottic larynx.

[Qualitative analysis of the perception of people who participate in a clinical trial, Navarra]. / Análisis cualitativo de la percepción que tienen las personas que participan en un ensayo clínico, Navarra.

BACKGROUND: The objective of this study is to explore the perception that participants in a clinical trial have about the information disclosured by the physician, during patient recruitment and along the study as a preliminary stage for drafting a questionnaire. METHODS: Qualitative study by means of quasi-structure interviews to subjects of different features taken from a patients list obtained by randomized selection of participants in clinical trials approved within the 1998-1999 period. For conducting the interviews, a guide was prepared based on the recommendations of the Helsinki Declaration. RESULTS: Six (6) interviews were held with 7 individuals, as one married couple was interviewed. Most of the categories encountered belonged to the Helsinki Declaration. In addition, others being related to the fulfillment of expectations and to the balance of the risks/benefits done by the individuals for deciding to take part in the study. CONCLUSIONS: The patients were acceptably informed of the most points dealt with under the Helsinki Declaration. The existence of lacking areas having a major impact on the fulfillment of their expectations however having been revealed.

Análisis cualitativo de la percepción que tienen las personas que participan en un ensayo clínico, Navarra / A qualitative analysis of patient's perceptions on the participation in clinical trials, Navarra, Spain

Fundamento: El objetivo del estudio es explorar la percepción que tienen los participantes en un ensayo clínico de la información facilitada por el médico, en el proceso de captación y durante la realización del mismo, como fase previa a la realización de un cuestionario. Métodos: Estudio cualitativo mediante entrevistas semiestructuradas a sujetos de distintas características, extraídos de un listado de pacientes mediante selección aleatoria de participantes en ensayos clínicos aprobados entre los años 1998-99. Para la realización de las entrevistas se elaboró un guión que recogía las recomendaciones de la Declaración de Helsinki. De la transcripción de las entrevistas se realizó el análisis de contenido. Resultados: Se realizaron 6 entrevistas a 7 personas, pues se entrevistó conjuntamente a un matrimonio. La mayor parte de las categorías encontradas pertenecían a la Declaración de Helsinki. Además, aparecieron otras relacionadas con la satisfacción de expectativas y con el balance riesgo/beneficio que los individuos realizan para tomar la decisión de participar en un ensayo. Conclusiones: Los pacientes fueron aceptablemente informados de muchos de los puntos que considera la Declaración de Helsinki, pero se puso de manifiesto la existencia de áreas más deficitarias con importante repercusión en el cumplimiento de sus expectativas (AU)

Background: The objective of this study is to explore the perception that participants in a clinical trial have about the information disclosured by the physician, during patient recruitment and along the study as a preliminary stage for drafting a questionnaire. Methods: Qualitative study by means of quasi-structure interviews to subjects of different features taken from a patients list obtained by randomized selection of participants in clinical trials approved within the 1998-1999 period. For conducting the interviews, a guide was prepared based on the recommendations of the Helsinki Declaration. Results: Six (6) interviews were held with 7 individuals, as one married couple was interviewed. Most of the categories encountered belonged to the Helsinki Declaration. In addition, others being related to the fulfillment of expectations and to the balance of the risks/benefits done by the individuals for deciding to take part in the study. Conclusions: The patients were acceptably informed of the most points dealt with under the Helsinki Declaration. The existence of lacking areas having a major impact on the fulfillment of their expectations however having been revealed (AU)