Time in Range Analysis in Automated Insulin Delivery Era: Should Day and Nighttime Targets be the Same?

INTRODUCTION: Hybrid closed-loop systems (HCLS) use has shown that time in range (TIR) tends to improve more during the nighttime than during the day. This study aims to compare the conventional TIR, currently accepted as 70 to 180 mg/dL, with a proposed recalculated time in range (RTIR) considering a tighter glucose target of 70 to 140 mg/dL for the nighttime fasting period in T1DM patients under HCLS. METHODS: We conducted a retrospective study that included adults patients receiving treatment with Tandem t:slim X2 Control-IQ. Daytime TIR was characterized as glucose values between 70 and 180 mg/dL during the 07:01 to 23:59 time frame. Nighttime fasting TIR was specified as glucose values from 70 to 140 mg/dL between 00:00 and 07:00. The combination of the daytime and nighttime fasting glucose targets results in an RTIR, which was compared with the conventional TIR for each patient. The 14 days Dexcom G6 CGM data were downloaded from Tidepool platform and analyzed. RESULTS: We included 22 patients with a mean age of 49.7 years and diabetes duration of 24.7 years, who had been using automatic insulin delivery (AID) HCLS for a median of 305.3 days. We verified a mean conventional TIR of 68.7% vs a mean RTIR of 60.3%, with a mean percentage difference between these two metrics of -8.4%. A significant decrease in conventional TIR was verified when tighter glucose targets were considered during the nighttime period. No significant correlation was found between the percentage difference values and RTIR, even among the group of patients with the lowest conventional TIR. CONCLUSIONS: Currently, meeting the conventional TIR metrics may fall short of achieving an ideal level of glycemic control. An individualized strategy should be adopted until further data become available for a precise definition of optimal glucose targets.

Persistence of Anti-S1 IgG against SARS-CoV-2 Eight Months after the Booster Dose of Vaccine in Naive and Previously Infected Healthcare Workers.

Our aim was to evaluate the immune response of healthcare workers included in the RIPOVAC study, after receiving a booster dose (third dose), in terms of intensity and persistence of induced antibodies. In the second phase of the RIPOVAC study, between December 2021 and January 2022, eight months after the second dose, 389 voluntary, immunocompetent, non-pregnant healthcare workers received a booster dose of SARS-CoV-2 vaccine, and a serum sample was obtained. Two groups of patients were established: with and without previous SARS-CoV-2 infection. In order to quantify anti-S1 IgG (AU/mL) we used CMIA (Abbott). All of the health workers were anti-S IgG positive 8 months after receiving the booster dose of the vaccine, with a mean of 17,040 AU/mL. In 53 patients without previous infection, antibody levels increased by a mean of 10,762 AU/mL. This figure is seven times higher than the one produced after the second dose (1506 AU/mL). The booster dose produces a robust elevation of the antibody level, which persists at 8 months, with levels significantly higher than those reached after the second dose, which allow one to predict a persistence of more than one year. The study demonstrates the efficacy of the booster dose of anti-SARS-CoV-2 vaccines.

Self-management in heart failure using mHealth: A content validation.

AIM: To describe the development of a mobile health application -mICardiApp- designed by a multidisciplinary professional team and patients with heart failure and to evaluate its content validity. METHODS: Critical reviews of the literature, semi-structured interviews with patients, and user stories guided the development of the content of the mobile application. These contents were refined and validated through a modified Delphi process. An expert panel of healthcare and social care professionals together with patients and academics evaluated the content through two content validity indicators, relevance, and adequacy, and provided narrative feedback. The content validity of the app and each screen was determined by calculating the Content Validity Index (CVI). Similarly, the Adequacy Index (AI) was analyzed. RESULTS: The developed app is composed by 8 topics: (1) available resources, (2) cardiac rehabilitation, (3) control of signs and symptoms, (4) emotional support, (5) learning and having fun, (6) medication, (7) nutrition, and (8) physical activity. The results demonstrated high CVI of the screens and the full app. 57 of the 59 screens in the app reached an excellent CVI ≥ 0.70 for both relevance and adequacy, except for 2 screens. The CVI Average Method of the app was 0.851. CONCLUSIONS: mICardiApp is presented as an application to improve health literacy and self-management of patients with multimorbidity and heart failure, with proven validation.

Assessment of humoral immune response to two mRNA SARS-CoV-2 vaccines (Moderna and Pfizer) in healthcare workers fully vaccinated with and without a history of previous infection.

AIMS: Presence of anti-S1 region of SARS-CoV-2 spike protein was analysed, at two and eight months, in 477 immunocompetent healthcare workers in Zaragoza, Spain, vaccinated with mRNA-1273 (Moderna) or BNT162b2 (Pfizer). METHODS AND RESULTS: Antibody analysis was performed with Alinity i System (Abbott). At 2 months, 100% of vaccinated had anti-S1 IgG (mean = 13,285 AU ml-1 ). This value was significantly higher with Moderna (18,192 AU ml-1 ) than with Pfizer (10,441 AU ml-1 ). The mean value of anti-S1 IgG after vaccination was significantly higher in patients with than without previous infection (18,539 vs. 7919 AU ml-1 ); in both groups was significantly higher with Moderna than with Pfizer (21,881 vs. 15,733 AU ml-1 and 11,949 vs. 6387 AU ml-1 ), respectively. At 8 months, 100% of patients were IgG positive, with higher levels with Moderna than with Pfizer. Nevertheless, in ensemble of cases, a mean decrease of antibody levels of 11,025 AU ml-1 was observed. CONCLUSION: At 2 and 8 months after vaccination, IgG response persists with both vaccines but with important decrease which suggests the need for revaccination. SIGNIFICANCE AND IMPACT OF STUDY: The study contributes to know the immune status after vaccination with two of more used anti-SARS-CoV-2 vaccines. This knowledge is important for establishing the best vaccination strategy.

Determination of the Concentration of IgG against the Spike Receptor-Binding Domain That Predicts the Viral Neutralizing Activity of Convalescent Plasma and Serum against SARS-CoV-2.

Several hundred millions of people have been diagnosed of coronavirus disease 2019 (COVID-19), causing millions of deaths and a high socioeconomic burden. SARS-CoV-2, the causative agent of COVID-19, induces both specific T- and B-cell responses, being antibodies against the virus detected a few days after infection. Passive immunization with hyperimmune plasma from convalescent patients has been proposed as a potentially useful treatment for COVID-19. Using an in-house quantitative ELISA test, we found that plasma from 177 convalescent donors contained IgG antibodies specific to the spike receptor-binding domain (RBD) of SARS-CoV-2, although at very different concentrations which correlated with previous disease severity and gender. Anti-RBD IgG plasma concentrations significantly correlated with the plasma viral neutralizing activity (VN) against SARS-CoV-2 in vitro. Similar results were found using an independent cohort of serum from 168 convalescent health workers. These results validate an in-house RBD IgG ELISA test in a large cohort of COVID-19 convalescent patients and indicate that plasma from all convalescent donors does not contain a high enough amount of anti-SARS-CoV-2-RBD neutralizing IgG to prevent SARS-CoV-2 infection in vitro. The use of quantitative anti-RBD IgG detection systems might help to predict the efficacy of the passive immunization using plasma from patients recovered from SARS-CoV-2.

Design of a nursing objective structured clinical examination of a first-year clinical practice program.

OBJECTIVE: The aim of the present study was to design a content-valid nursing objective structured clinical examination attending a first-year clinical nursing practice program. METHOD: The examination was designed following a procedure based on the consensus of experts which was comprised of three phases: selection of the activities in which students should be competent according to the learning outcomes of the course, clinical case design, and integration of the clinical cases designed into the stations of the test. RESULTS: Of the 44 surveys submitted for the design of the stations, 37 were answered, of which 31 respondents met the inclusion criteria of the panel of experts. The activities on which the experts reached the highest degrees of consensus were: basic physical assessment and monitoring of vital signs, assessment of hygiene and skin status, ability to develop care plans, management of safety principles in administration of medication and administration of oral medication. Based on the selected activities, the experts developed 20 clinical cases, from which a four-station nursing objective structured clinical examination was designed. CONCLUSION: The structured methodology based on the design of experts enabled the design of a content-valid objective structured clinical examination appropriate for the evaluation of the learning outcomes achieved by the students attending a clinical practice program.

Design of a nursing objective structured clinical examination of a first-year clinical practice program / Projeto de um exame clínico estruturado objetivo de enfermagem de um programa de prática clínica do primeiro ano / Diseño de una prueba de evaluación clínica objetiva estructurada de cuidados de enfermería del primer curso de prácticas clínicas

ABSTRACT Objective: The aim of the present study was to design a content-valid nursing objective structured clinical examination attending a first-year clinical nursing practice program. Method: The examination was designed following a procedure based on the consensus of experts which was comprised of three phases: selection of the activities in which students should be competent according to the learning outcomes of the course, clinical case design, and integration of the clinical cases designed into the stations of the test. Results: Of the 44 surveys submitted for the design of the stations, 37 were answered, of which 31 respondents met the inclusion criteria of the panel of experts. The activities on which the experts reached the highest degrees of consensus were: basic physical assessment and monitoring of vital signs, assessment of hygiene and skin status, ability to develop care plans, management of safety principles in administration of medication and administration of oral medication. Based on the selected activities, the experts developed 20 clinical cases, from which a four-station nursing objective structured clinical examination was designed. Conclusion: The structured methodology based on the design of experts enabled the design of a content-valid objective structured clinical examination appropriate for the evaluation of the learning outcomes achieved by the students attending a clinical practice program.

RESUMO Objetivo: O objetivo do presente estudo foi elaborar um exame clínico estruturado de objetivos de enfermagem com conteúdo válido, participando de um programa de prática clínica de enfermagem do primeiro ano. Método: O exame foi elaborado seguindo um procedimento baseado no consenso de especialistas que compreendeu três fases: seleção das atividades nas quais os alunos deveriam ser competentes de acordo com os resultados de aprendizagem do curso, desenho do caso clínico e integração do quadro clínico casos projetados para as estações do teste. Resultados: Das 44 pesquisas submetidas para a concepção das estações, 37 foram respondidas, das quais 31 respondentes atenderam aos critérios de inclusão do painel de especialistas. As atividades nas quais os especialistas alcançaram maior grau de consenso foram: avaliação física básica e monitoramento dos sinais vitais, avaliação da higiene e do estado da pele, capacidade de desenvolver planos de cuidados, gestão dos princípios de segurança na administração de medicamentos e administração de medicamentos orais. Com base nas atividades selecionadas, os especialistas desenvolveram 20 casos clínicos, a partir dos quais foi elaborado um exame clínico estruturado objetivo de enfermagem em quatro estações. Conclusão: A metodologia estruturada baseada na concepção de especialistas permitiu a concepção de um exame clínico estruturado objetivo válido e de conteúdo adequado para a avaliação dos resultados de aprendizagem alcançados pelos alunos que frequentam um programa de prática clínica.

RESUMEN Objetivo: El objetivo de este estudio fue diseñar una Evaluación Clínica Objetiva Estructurada con validez de contenido para evaluar el nivel de competencias de estudiantes de primer curso de formación practico-clínica enfermera. Método: Se diseñó la prueba siguiendo un procedimiento basado en consenso de expertos con tres fases: selección de las actividades en la que los alumnos debían ser competentes en base a los resultados de aprendizaje de la asignatura, diseño de casos clínicos, e integración de los casos clínicos diseñados en las estaciones de la prueba. Resultados: Las actividades que alcanzaron mayor consenso por parte de los expertos fueron: valoración física básica y monitorización de signos vitales, valoración de la higiene y estado de la piel, capacidad para elaborar planes de cuidados, manejo de los principios de seguridad en la administración de medicación y administración de medicación oral. En base a las actividades seleccionadas, los expertos elaboraron 20 casos clínicos, a partir de los cuales se diseñó una evaluación clínica objetiva estructurada de cuidados de enfermería formada por cuatro estaciones. Conclusión: La metodología estructurada basada en el diseño de expertos permitió el diseño de una evaluación clínica objetiva estructurada adecuada para evaluar los resultados de aprendizaje alcanzados por los estudiantes de primer curso de formación práctico-clínica.

A Student Assessment Tool for Standardized Patient Simulations (SAT-SPS): Psychometric analysis.

BACKGROUND: The evaluation of the level of clinical competence acquired by the student is a complex process that must meet various requirements to ensure its quality. The psychometric analysis of the data collected by the assessment tools used is a fundamental aspect to guarantee the student's competence level. AIM: To conduct a psychometric analysis of an instrument which assesses clinical competence in nursing students at simulation stations with standardized patients in OSCE-format tests. METHOD: The construct of clinical competence was operationalized as a set of observable and measurable behaviors, measured by the newly-created Student Assessment Tool for Standardized Patient Simulations (SAT-SPS), which was comprised of 27 items. The categories assigned to the items were 'incorrect or not performed' (0), 'acceptable' (1), and 'correct' (2). PARTICIPANTS: 499 nursing students. Data were collected by two independent observers during the assessment of the students' performance at a four-station OSCE with standardized patients. Descriptive statistics were used to summarize the variables. The difficulty levels and floor and ceiling effects were determined for each item. Reliability was analyzed using internal consistency and inter-observer reliability. The validity analysis was performed considering face validity, content and construct validity (through exploratory factor analysis), and criterion validity. RESULTS: Internal reliability and inter-observer reliability were higher than 0.80. The construct validity analysis suggested a three-factor model accounting for 37.1% of the variance. These three factors were named 'Nursing process', 'Communication skills', and 'Safe practice'. A significant correlation was found between the scores obtained and the students' grades in general, as well as with the grades obtained in subjects with clinical content. CONCLUSIONS: The assessment tool has proven to be sufficiently reliable and valid for the assessment of the clinical competence of nursing students using standardized patients. This tool has three main components: the nursing process, communication skills, and safety management.

Changes in foot posture during pregnancy and their relation with musculoskeletal pain: A longitudinal cohort study.

AIM: To examine foot posture changes during the three trimesters of pregnancy and to determine whether there is a relationship between these changes and the pain experienced in this period. METHODS: The study sample consisted of 62 pregnant women who attended the Gynaecology Service at Hospital ​Santa María del Puerto (Cádiz, Spain), between January 2013 and May 2014. In their first visit, the following sociodemographic and anthropometric data were recorded: age, weight, height and foot size. In addition, information was obtained regarding pain in the lower back, knees, ankles and feet. In this first visit, too, the Foot Posture Index (FPI) was assessed, and three subsequent controls were performed during the first, second and third months of pregnancy (termed Stages 1, 2 and 3, respectively). RESULTS: In Stage 1, the average foot size (i.e., shoe size) was 38.3 (SD 1.5). This size did not change between Stages 1, 2 and 3. However, body weight and BMI did present statistically significant changes during this period (p<0.0001). The FPI varied during pregnancy but no relation was observed between these changes and the onset of pain. CONCLUSIONS: During pregnancy, pronation increases but this does not appear to influence the onset of pain in the lower limbs.

Nursing diagnosis of grieving: content validity in perinatal loss situations.

PURPOSE: To validate the content of the NANDA-I nursing diagnosis of grieving in situations of perinatal loss. METHODS: Using the Fehring's model, 208 Spanish experts were asked to assess the adequacy of the defining characteristics and other manifestations identified in the literature for cases of perinatal loss. FINDINGS: The content validity index was 0.867. Twelve of the 18 defining characteristics were validated, seven as major and five as minor. From the manifestations proposed, "empty inside" was considered as major. CONCLUSION: The nursing diagnosis of grieving fits in content to the cases of perinatal loss according to experts. IMPLICATIONS FOR NURSING PRACTICE: The results have provided evidence to support the use of the diagnosis in care plans for said clinical situation.

Desarrollo y evaluacion psicometrica de una forma abreviada de la escala de posicionamiento ante el diagnostico enfermero / A forma abreviada da escala posições frente ao diagnostico de enfermagem: desenvolvimento e avaliação psicométrica / A short form of the positions on nursing diagnosis scale: development and psychometric testing

El Position on Nursing Diagnosis (PND) es una escala que utiliza la técnica del diferencial semántico para medir las actitudes hacia el concepto diagnóstico enfermero. El estudio objetivó desarrollar una forma abreviada de la versión española de esta escala, evaluar sus propiedades psicométricas y eficiencia. Se utilizó un doble enfoque empírico-teórico para obtener una forma reducida del PND, el PND-7-SV, que fuera equivalente a la original. Mediante un diseño transversal a través de encuesta, se evaluó la fiabilidad (consistencia interna y fiabilidad test-retest), validez de constructo (análisis factorial exploratorio, técnica de grupos conocidos y validez discriminante) y de criterio (validez concurrente), sensibilidad al cambio y eficiencia del PND-7-SV en una muestra de 476 estudiantes de enfermería españoles. Los resultados avalaron la utilidad del PND-7-SV para medir las actitudes hacia el diagnóstico enfermero de manera equivalente a la forma completa de la escala y en un tiempo más reducido.

O Position on Nursing Diagnosis (PND) é uma escala que utiliza a técnica do diferencial semântico para medir atitudes em relação ao conceito diagnóstico de enfermagem. O objetivo deste estudo foi desenvolver uma forma abreviada da versão em espanhol desta escala e avaliar suas propriedades psicométricas e eficiência. Foi utilizada uma dupla abordagem teórico-empírica para obter uma forma curta do PND, o PND-7-SV, que era equivalente à original. Usando um desenho transversal através de pesquisa, foi avaliada a confiabilidade (consistência interna e confiabilidade teste-reteste), validade de constructo (análise fatorial exploratória, técnica de grupos conhecidos e validade discriminante) e de critério (validade concorrente), sensibilidade à mudança e eficiência da PND-7-SV em uma amostra de 476 estudantes de enfermagem espanholas. Os resultados endossaram a utilidade do PND-7-SV para medir atitudes em relação ao diagnóstico de enfermagem de maneira equivalente à forma completa da escala e em um curto tempo.

The Positions on Nursing Diagnosis (PND) is a scale that uses the semantic differential technique to measure nurses' attitudes towards the nursing diagnosis concept. The aim of this study was to develop a shortened form of the Spanish version of this scale and evaluate its psychometric properties and efficiency. A double theoretical-empirical approach was used to obtain a short form of the PND, the PND-7-SV, which would be equivalent to the original. Using a cross-sectional survey design, the reliability (internal consistency and test-retest reliability), construct (exploratory factor analysis, known-groups technique and discriminant validity) and criterion-related validity (concurrent validity), sensitivity to change and efficiency of the PND-7-SV were assessed in a sample of 476 Spanish nursing students. The results endorsed the utility of the PND-7-SV to measure attitudes toward nursing diagnosis in an equivalent manner to the complete form of the scale and in a shorter time.

The Spanish version of the Position on Nursing Diagnosis scale: cross-cultural adaptation and psychometric assessment.

AIM: To report the adaptation into Spanish and psychometric testing of the Position on Nursing Diagnosis scale. BACKGROUND: The Position on Nursing Diagnosis is a scale that uses the semantic differential technique to measure nurses' attitudes towards the nursing diagnosis concept. DESIGN: Methodological design. METHOD: The scale was cross-culturally adapted through a process including translation, comparison with versions in other languages, back-translation, review, and pre-testing. An opportunistic sample of 621 Spanish registered nurses was recruited from August-December 2011. Reliability was evaluated through internal consistency and test-retest reliability. Construct validity, using both exploratory factor analysis and the known-group technique, and concurrent validity were assessed. FINDINGS: The Position on Nursing Diagnosis-Spanish Version was obtained from the cross-cultural adaptation process. High internal consistency and satisfactory test-retest reliability over a two week period (n = 240) were found. In the principal component analysis, all items loaded strongly on a single-factor which accounted for adequate variance, supporting the unidimensionality of the scale. A statistically significant difference was found comparing the scores of nurses who were members of the Spanish Association of Nomenclature, Taxonomy and Nursing Diagnosis and those who were not. Concurrent validity was supported by the significant correlation found between the scores and the degree of nursing diagnosis utilization and attendance to training sessions. CONCLUSION: The findings support the validity and reliability of the Position on Nursing Diagnosis-Spanish Version for its use among Spanish registered nurses as a measurement of their attitude towards the nursing diagnosis concept.

[A short form of the positions on nursing diagnosis scale: development and psychometric testing]. / Desarrollo y evaluación psicométrica de una forma abreviada de la escala de posicionamiento ante el diagnóstico enfermero.

The Positions on Nursing Diagnosis (PND) is a scale that uses the semantic differential technique to measure nurses' attitudes towards the nursing diagnosis concept. The aim of this study was to develop a shortened form of the Spanish version of this scale and evaluate its psychometric properties and efficiency. A double theoretical-empirical approach was used to obtain a short form of the PND, the PND-7-SV, which would be equivalent to the original. Using a cross-sectional survey design, the reliability (internal consistency and test-retest reliability), construct (exploratory factor analysis, known-groups technique and discriminant validity) and criterion-related validity (concurrent validity), sensitivity to change and efficiency of the PND-7-SV were assessed in a sample of 476 Spanish nursing students. The results endorsed the utility of the PND-7-SV to measure attitudes toward nursing diagnosis in an equivalent manner to the complete form of the scale and in a shorter time.

Tackling perinatal loss, a participatory action research approach: research protocol.

AIM: The aim of this study was to promote changes to improve the care provided to parents who have experienced a perinatal loss through participatory action research. BACKGROUND: The birth of a child is a joyful event for most families, however, unfortunately some pregnancies end in loss. Perinatal loss creates a heavy emotional impact not only on parents but also on health professionals, where in most cases there is an evident lack of skills, strategies and resources to cope with these kinds of situations. DESIGN: Participatory action research is the methodology proposed to achieve the purpose of this study. METHODS: Participatory action research consists of five stages: outreach and awareness, induction, interaction, implementation and systematization. The working group will include professionals from the Mother and Child Unit for patients at a tertiary level public hospital in Spain. The duration of the study will be 3 years since the approval of the protocol in January 2011. The qualitative techniques used will include group dynamics such as the SWOT analysis the nominal group technique, focus groups and brainstorming, among others that will be recorded and transcribed, generating reports throughout the evolution of the group sessions and about the consensus reached. Content analysis will be conducted on the field diaries kept by the participants and researchers. This project has been funded by the Andalusian Regional Ministry of Health. DISCUSSION: Participatory action research is a methodological strategy that allows changes in clinical practice to conduct a comprehensive transformative action in the care process for perinatal loss.