Social sciences, art and physical activity in leisure environments. An inter-disciplinary project for teacher training

Factors such as social change and increasing urbanization processes in the early years of the 21st century have caused a reduction in the amount of time that children devote to leisure activities in the open-air, resulting in more sedentary lifestyles than children in previous decades. An education in healthy habits from early ages to increase children’s physical and mental well-being together with their level of cultural knowledge contributes to the acquisition of a Leisure Culture that allows children to perceive the close environment as a scene for learning and enjoyment. It is thus be necessary for schools to foster pedagogical experiences, taking the physical and cultural environment as teaching resources. An innovation project is proposed which will be implemented with 25 university students from the School of Teacher Training and Education at the University of Oviedo (Oviedo, Spain). The project will consist of the proposal of educational itineraries through the city of Oviedo and Mount Naranco. As teachers-to-be, students must combine knowledge of the related areas and generate inter-disciplinary activities throughout the routes that will foster respect for the environment and leisure based on culture and physical activity, attitudes that they will transmit to their own students in the future

Utilidad de una estrategia de cribado de hipertensión ocular y glaucoma en atención primaria

ObjetivosEvaluar la utilidad de una estrategia de cribado de glaucoma e hipertensión ocular (HTO) medida como número de casos detectados. Evaluar la aceptabilidad de la toma de presión intraocular (PIO) y la aparición de efectos secundarios.DiseñoEstudio descriptivo transversal.EmplazamientoCentro de salud urbano y consulta de oftalmología del hospital de referencia.ParticipantesEn total, 2.044 pacientes mayores de 40 años, seleccionados por muestreo consecutivo entre los que consultaron en el centro de salud durante 9 meses. Se excluyeron los sujetos diagnosticados de glaucoma, HTO, conjuntivitis o enfermedad corneal.IntervencionesToma de PIO con Tonopen XL en atención primaria. Se remitió a oftalmología a los sujetos con una PIO≥21 mmHg. En éstos se midió la PIO con la prueba de Goldmann y, en los que se confirmó la HTO, se realizaron una oftalmoscopia y una campimetría.Mediciones principalesPorcentaje de sujetos con glaucoma, sospecha de glaucoma e HTO confirmada en oftalmología. Valor predictivo positivo (VPP) para HTO.ResultadosSe detectaron 100 sujetos con HTO (4,89%; intervalo de confianza [IC] del 95%, 3,93-5,85%), de los que 21 fueron diagnosticados de glaucoma (1,04%; IC del 95%, 0,57-1,49%) y 10 de sospecha de glaucoma (0,49%; IC del 95%, 0,16-0,82). El VPP para HTO fue del 44,27%. La aceptabilidad de la prueba fue del 98,09%. Ningún paciente presentó efectos secundarios tras la toma de la PIO.ConclusionesLa estrategia evaluada es útil en cuanto al porcentaje de sujetos con glaucoma e HTO detectados. La aceptabilidad de la toma de la PIO con Tonopen XL es alta.ObjectivesTo evaluate the usefulness of a glaucoma and intraocular hypertension screening strategy for new cases detected. To evaluate the acceptability of taking intraocular pressure (IOP) and the appearance of side effects.DesignCross-sectional, descriptive study.SettingAn urban health centre and the ophthalmology clinic of its main hospital.ParticipantsA total of 2044 patients aged over 40, 63.5% women and 36.5% men, with a mean age of 61.23 (SD, 11.42). They were selected by consecutive sampling from patients who visited the health centre over a 9-month period. Subjects diagnosed with glaucoma, ocular hypertension (OH), conjunctivitis, or corneal pathology were excluded.InterventionsTaking of IOP with Tonopen XL in primary care. Subjects with IOP ≥21 mm Hg were referred to ophthalmology. In these patients, IOP was measured with Goldmann, and patients with confirmed OH received ophthalmoscopy and campimetry.Main measurementsPercentage of subjects with glaucoma, suspected glaucoma, and OH confirmed in ophthalmology. Positive predictive value (PPV) for OH.ResultsOne hundred subjects with OH were detected (4.89%; 95% CI, 3.93%-5.85%), of whom 21 were diagnosed with glaucoma (1.04%; 95% CI, 0.57-1.49) and 10 with suspected glaucoma (0.49%; 95% CI, 0.16-0.82). The PPV for OH was 44.27%. The acceptability of the test was 98.09%. No patients presented with side-effects following the taking of their IOP.ConclusionsThe strategy evaluated is useful in terms of the number of subjects with glaucoma and OH detected. The acceptability of taking IOP with Tonopen XL was high

Adjusted morbidity groups: Characteristics and comorbidities in patients with chronic conditions according to their risk level in Primary Care

Objetivos: Describir las características de los pacientes crónicos según el nivel de riesgo asignado por los grupos de morbilidad ajustados (GMA). Analizar los factores asociados al nivel de riesgo alto y estudiar el efecto de cada uno de ellos. Dise˜no: Estudio observacional descriptivo transversal con enfoque analítico. Emplazamiento: Atención Primaria (AP). Servicio Madrile˜no de Salud. Participantes: Población de 18.107 pacientes estratificados por los GMA integrados en la historia clínica electrónica de AP de la Comunidad de Madrid. Mediciones principales: Variables sociodemográficas, clínico-asistenciales y de uso de servicios. Se realizó análisis univariado, bivariado y multivariante. Resultados: De los 18.107 pacientes se identificaron 9.866 (54,4%) pacientes crónicos, 444 (4,5%) estratificados como de alto riesgo, 1.784 (18,1%) como de medio riesgo y 7.638 (77,4%) como de bajo riesgo. Los de alto riesgo, comparados con medio y bajo riesgo, tenían una edad media mayor (77,8 [12,9]; 72,1 [12,9]; 50,6 [19,4]), menor porcentaje de mujeres (52,3%, 65%, 61,1%), mayor número de enfermedades crónicas (6,7 [2,4]; 4,3 [1,5]; 1,9 [1,1]), polimedicación (79,1%, 43,3%, 6,2%) y contactos con AP (33,9 [28]; 21,4 [17,3]; 7,9 [9,9]) (p < 0,01). En el multivariante el nivel de riesgo alto se relacionó de manera independiente con la edad > 65 (OR = 1,43; IC 95% = 1,03-1,99), sexo masculino (OR = 3,46; IC 95% = 2,64-4,52), inmovilidad (OR = 6,33; IC 95% = 4,40-9,11), número de enfermedades crónicas (OR = 2,60; IC 95% = 2,41-2,81) (p < 0,01) y número de contactos con AP > 7 (OR = 1,95; IC 95% = 1,36-2,80). Conclusiones: Más de la mitad de la población fue clasificada por los GMA como crónica, y se estratificó en 3 niveles de riesgo que presentaban diferencias en sexo, edad, deterioro funcional, necesidad de cuidados, morbilidad, complejidad, polifarmacia y contactos con AP. La edad > 65, el sexo masculino, la inmovilidad, el número de enfermedades crónicas y los contactos con AP > 7 fueron los factores asociados al alto riesgo.Aims: To describe the characteristics of patients with chronic conditions according to their risk levels assigned by the adjusted morbidity groups (AMG). To analyse the factors associated with a high risk level and to study their effect. Design: Observational cross-sectional study with an analytical focus. Location: Primary care (PC), Madrid Health Service. Participants: Population of 18,107 patients stratified by their risk levels with the AMG in the computerised clinical records of Madrid PC. Main measurements: The variables studied were: socio-demographic, clinical-nursing care and use of services. Univariate, bivariate, and multivariate analysis were performed. Results: Of the 18,107 patients, 9,866(54.4%) were identified as chronic patients, with 444 (4.5%) stratified as high risk, 1784 (18,1%) as medium risk, and 7,638 (77.4%) as low risk. The high risk patients, compared with medium and low risk, had an older mean age [77.8 (SD = 12.9), 72.1 (SD = 12.9), 50.6 (SD = 19.4)], lower percentage of women (52.3%, 65%, 61.1%), a higher number of chronic diseases [6.7 (SD = 2.4), 4.3 (SD = 1.5), 1.9 (SD = 1.1)], polymedication (79.1%, 43.3%, 6.2%), and contact with PC [33.9 (28), 21.4 (17.3), 7.9 (9.9)] (P <. 01). In the multivariate analysis, the high risk level was independently related to age > 65 [1.43 (1.03-1.99), male gender (OR = 3.46, 95% CI = 2.64-4.52), immobility (OR = 6.33, 95% CI = 4.40-9.11), number of chronic conditions (OR = 2.60, 95% CI = 2.41-2.81), and PC contact > 7 times (OR = 1.95, 95% CI = 1.36- 2.80)] (P < .01). Conclusions: More than half of the population is classified by the AMG as a chronic, and it is stratified into 3 risk levels that show differences in gender, age, functional impairment, need for care, morbidity, complexity, and use of Primary Care services. Age > 65, male gender, immobility, number of chronic conditions, and contact with PC > 7 times were the factors associated with high risk

Health services utilization in Primary Care in patients with chronic conditions according to risk levels

Fundamentos: Los pacientes crónicos sufren mayor número de problemas de salud y tienen mayores necesidades de asistencia y cuidados. El objetivo de este estudio fue describir la utilización de servicios de salud de Atención Primaria en los pacientes crónicos según el nivel de riesgo asignado por los grupos de morbilidad ajustados (GMA), así como analizar los factores asociados. Sujetos y métodos: Se realizó un estudio transversal. Se incluyeron pacientes ≥ 18 años identificados como crónicos por el estratificador GMA en una zona básica de salud de la Comunidad de Madrid, con una población adscrita de 18.107 habitantes. Se recogieron variables sociodemográficas, clínico-asistenciales y de utilización de servicios, y se clasificaron según el modelo “conductual” en “factores predisponentes”, “factores de necesidad” o “factores facilitadores”. Se empleó un análisis univariado, bivariado y multivariante, ajustando un modelo de regresión lineal múltiple con estimadores robustos. Resultados: Se incluyeron 9.443 pacientes crónicos (el 52,1% de la población de la zona seleccionada), con una edad media de 57,8 años (Desviación estándar [DE]=18,7), siendo mujeres el 62,1%. El 4,7% eran pacientes de alto riesgo, el 18,7% de medio riesgo y el 76,6% presentaba bajo riesgo. La media de contactos/año fue de 14,1 (DE=15,2). 34,4 (DE=27,9) en alto riesgo, 21,8 (DE=17,2) en riesgo medio y 10,1 (DE=10,2) en bajo riesgo. De estos contactos, 7,5 (DE=7,1) fueron con médico y 12,9 (DE=12,9) presenciales. Los factores asociados a mayor utilización fueron el riesgo alto (Coeficiente B [CB]=12,6; IC95%=11,1-14,2), el estar inmovilizado (CB=8,8; IC95%=7,3-10,4), la polimedicación (CB=6; IC95%=5,1-6,9), el ser mujer (CB=1; IC95%=0,4-1,5), el número de enfermedades crónicas (CB=1; IC95%=0,8-1,2) y la edad (CB=0,03; IC95%=0,01-0,05). Conclusiones: La utilización de servicios de Atención Primaria en los pacientes crónicos es elevada y aumenta según el nivel de riesgo asignado por los GMA. El contacto con el médico es superior frente al de la enfermería, y el tipo más frecuente es presencial. La mayor utilización responde a factores predisponentes (ser mujer y la edad) y, sobre todo, de necesidad clínica (alto riesgo, multimorbilidad, polimedicación e inmovilidad).Background: Chronic patients suffer a greater number of health problems and have greater needs for assistance and care. The objective was to describe the use of health services in Primary Care in patients with chronic conditions according to risk level by adjusted morbidity groups (AMG) and analyze the associated factors. Methods: Cross-sectional study. We included patients ≥18 years-old identified as chronic by the stratification tool according to AMG in a basic health area in the Community of Madrid with an assigned population of 18,107 inhabitants. Sociodemographic, clinical-care and use of services variables were collected and were classified according to the “behavioral” model in predisposing, need or facilitators factors. Univariate, bivariate and multiple linear regression adjusted with robust estimators was performed. Results: 9,443 chronic patients (52.1% of the population in the selected zone) were identified, mean age of 57.8 (SD=18.7); 62.1% women. According to their risk level 4.7% were high risk, 18.7% medium risk and 76.6% low risk. The mean number of contacts per year was 14.1 (SD=15.2); 34.4 (SD=27.9) in high risk; 21.8 (SD=17.2) in medium risk and 10.1 (SD=10.2) in low risk. 7.5 (SD=7.1) contacts were with the doctor and 12.9 (SD=12.9) were face- to-face. The factors associated with higher use of services were high risk (Coefficient B[CB]=12.6; IC95%=11-14.2), immobilization (CB=8.8; IC95%=7.3-10.4), polypharmacy (CB=6; IC95%=5- 8.6), female sex (CB=1; IC95%=0.4-1.5), number of chronic diseases (CB=1; IC95%=0.8-1.2) and age (CB=0.03; IC95%=0.01-0.05). Conclusions: The health services utilization in Primary Care in chronic patients is high and increased according with the risk level by AMG. The contact with the doctor is superior to nurse and the most frequent type is face-to-face. The greater utilization of services responds to predisposing factors (female sex and age) and above all to need factors (high risk, immobility, multimorbidity and polypharmacy).Ayuda para la elaboración de tesis doctorales de la Fundación para la Investigación e Innovación Biomédica de Atención Primaria (FIIBAP) de la Comunidad de Madrid

Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial

Background: The rates of exclusive breastfeeding at 6months in Spain are far from recommended by the World Health Organization, which is 50% by 2025. Evidence of the efectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the efectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6months compared to the usual practice in primary care. Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads who breastfed exclusively in the frst 4weeks of the children’s life and agreed to participate were included. The main outcome was exclusive breast‑feeding at 6months. Secondary variables were type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the efectiveness, the diference in the proportions of dyads with exclusive breastfeeding at 6months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6months, a multilevel logistic regression model was ftted. All analyses were performed to intention to treat. Results: The percentage of dyads with exclusive breastfeeding at 6months was 22.4% in the intervention group and 8.8% in the control group. PROLACT intervention obtained an RR =2.53 (95% CI: 1.54–4.15) and an NNT=7 (95%CI: 5–14). The factors associated with exclusive breastfeeding at 6months were the PROLACT intervention, OR=3.51 (95%CI: 1.55–7.93); age>39 years, OR=2.79 (95%CI: 1.02–7.6); previous breastfeeding experience, OR=2.61 (95%CI: 1.29–5.29); income between 500 and 833.33 €, OR=3.52 (95%CI 1.47–8.47).); planning to start work before the infant was 6months old, OR=0.35 (0.19–0.63). Conclusions: The PROLACT intervention in primary care is more efective than the usual practice for maintaining exclusive breastfeeding at 6months, and can therefore be considered evidence-based practice for implementation in standard practice. Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).This study was funded by the Projects PI12/02609 and PI12/02020 as a part of the Plan Nacional de I+D+I (National Plan for R+D+I) and co-funded by the ISCIII Subdirectorate General for Evaluation and the European Regional Development Fund (ERDF). The primary researcher received a grant for publication from the Fundación para la Investigación e Innovacion en Atención Primaria (Foundation for Research and Innovation in Primary Care) in its 2019 call. The funding source had no role in the design of this study and did not have any role in its execution, analyses, interpretation of the data or the decision to submit the results.S

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection : a double-blind, placebo-controlled, randomised clinical trial

Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. registry: . 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19.

Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

BACKGROUND: Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. METHODS/DESIGN: This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. DISCUSSION: This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].S

Mental impact of Covid-19 among Spanish healthcare workers. A large longitudinal survey

Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Ministerio de Ciencia e Innovación; Gerencia Regional de Salud de Castilla y León (SACYL, GRS COVID 32/A/20).Aims Longitudinal data on the mental health impact of the coronavirus disease 2019 (Covid-19) pandemic in healthcare workers is limited. We estimated prevalence, incidence and persistence of probable mental disorders in a cohort of Spanish healthcare workers (Covid-19 waves 1 and 2) -and identified associated risk factors. Methods 8996 healthcare workers evaluated on 5 May-7 September 2020 (baseline) were invited to a second web-based survey (October-December 2020). Major depressive disorder (PHQ-8 ≥ 10), generalised anxiety disorder (GAD-7 ≥ 10), panic attacks, post-traumatic stress disorder (PCL-5 ≥ 7), and alcohol use disorder (CAGE-AID ≥ 2) were assessed. Distal (pre-pandemic) and proximal (pandemic) risk factors were included. We estimated the incidence of probable mental disorders (among those without disorders at baseline) and persistence (among those with disorders at baseline). Logistic regression of individual-level [odds ratios (OR)] and population-level (population attributable risk proportions) associations were estimated, adjusting by all distal risk factors, health care centre and time of baseline interview. Results 4809 healthcare workers participated at four months follow-up (cooperation rate = 65.7%; mean = 120 days s.d. = 22 days from baseline assessment). Follow-up prevalence of any disorder was 41.5%, (v. 45.4% at baseline, p < 0.001); incidence, 19.7% (s.e. = 1.6) and persistence, 67.7% (s.e. = 2.3). Proximal factors showing significant bivariate-adjusted associations with incidence included: work-related factors [prioritising Covid-19 patients (OR = 1.62)], stress factors [personal health-related stress (OR = 1.61)], interpersonal stress (OR = 1.53) and financial factors [significant income loss (OR = 1.37)]. Risk factors associated with persistence were largely similar. Conclusions Our study indicates that the prevalence of probable mental disorders among Spanish healthcare workers during the second wave of the Covid-19 pandemic was similarly high to that after the first wave. This was in good part due to the persistence of mental disorders detected at the baseline, but with a relevant incidence of about 1 in 5 of HCWs without mental disorders during the first wave of the Covid-19 pandemic. Health-related factors, work-related factors and interpersonal stress are important risks of persistence of mental disorders and of incidence of mental disorders. Adequately addressing these factors might have prevented a considerable amount of mental health impact of the pandemic among this vulnerable population. Addressing health-related stress, work-related factors and interpersonal stress might reduce the prevalence of these disorders substantially. Study registration number: NCT0455656

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.This study was funded by the Spanish Ministry of Science and Innovation via the Instituto de Salud Carlos III, Subprograma de Proyectos de Investigación en Evaluación de Tecnologías Sanitarias y Servicios de Salud (PI 09/90354), and the Fundación de Investigación e Innovación Biomédica en Atención Primaria (FIIBAP). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscriptS

Patient preferences and treatment safety for uncomplicated vulvovaginal candidiasis in primary health care

<p>Abstract</p> <p>Background</p> <p>Vaginitis is a common complaint in primary care. In uncomplicated candidal vaginitis, there are no differences in effectiveness between oral or vaginal treatment. Some studies describe that the preferred treatment is the oral one, but a Cochrane's review points out inconsistencies associated with the report of the preferred way that limit the use of such data. Risk factors associated with recurrent vulvovaginal candidiasis still remain controversial.</p> <p>Methods/Design</p> <p>This work describes a protocol of a multicentric prospective observational study with one year follow up, to describe the women's reasons and preferences to choose the way of administration (oral vs topical) in the treatment of not complicated candidal vaginitis. The number of women required is 765, they are chosen by consecutive sampling. All of whom are aged 16 and over with vaginal discharge and/or vaginal pruritus, diagnosed with not complicated vulvovaginitis in Primary Care in Madrid.</p> <p>The main outcome variable is the preferences of the patients in treatment choice; secondary outcome variables are time to symptoms relief and adverse reactions and the frequency of recurrent vulvovaginitis and the risk factors. In the statistical analysis, for the main objective will be descriptive for each of the variables, bivariant analysis and multivariate analysis (logistic regression).. The dependent variable being the type of treatment chosen (oral or topical) and the independent, the variables that after bivariant analysis, have been associated to the treatment preference.</p> <p>Discussion</p> <p>Clinical decisions, recommendations, and practice guidelines must not only attend to the best available evidence, but also to the values and preferences of the informed patient.</p