Financial impact of the hospital pharmacy's participation in clinical trials.

OBJECTIVES: To estimate the cost of the hospital pharmacy's participation in clinical trials (CTs) and to compare it to the amount received in compensation from sponsors.To analyse the financial impact of CTs that end without recruiting any patients and without any financial compensation from promoters. METHODS: This retrospective observational study analysed data from 5 years (2014-2018) at a tertiary university hospital.We established an allocation formula taking into account direct costs related to the pharmacy department's CT area's activity (reception, safekeeping, preparation, devolution, and destruction of medication, as well as patient monitoring) and indirect costs (facilities, resources, support staff). We calculated the costs to the department and the compensation received both overall and based on the type of promoter, clinical department involved in the trial, and the number of patients included. RESULTS: We included 134 trials. Costs added up to €207 372.95 and the compensation to €149 128.93 (€58 244.02 loss for the department). Trials ending without recruiting patients (33.6%) and without compensation accounted for 57.45% of the deficit. The mean cost of trials ending without recruiting patients was €875. We plan to charge a reimbursable setup fee for opening CTs to safeguard against these losses (€875 for trials in all departments except oncology; €1100 for oncology because 38% of their trials end without recruiting patients) and to compensate for the costs incurred in participating in trials for cooperative groups without financial compensation (20%). CONCLUSIONS: Billing sponsors based on costs incurred for each trial would be a fairer system than the current approach based on the number of patients included. Establishing an initial fee would make up for losses from trials that fail to recruit any patients.

Decline in fertility induced by economic recession in Spain.

OBJECTIVE: To describe trends in fertility in Spain before (pre-recession; 1998-2008) and during (recession period; 2009-2013) the economic crisis of 2008, taking into account women's age and regional unemployment in 2010. METHOD: The study consisted of a panel design including cross-sectional ecological data for the 17 regions of Spain. We describe fertility trends in Spain in two time periods, pre-recession (1998-2008) and recession (2009-2013). We used a cross-sectional, ecological study of Spanish-born women to calculate changes in fertility rates for each period using a linear regression model adjusted for year, period, and interaction between them. RESULTS: We found that compared to the pre-recession period, the fertility rate in Spain generally decreased during the economic recession. However, in some regions, such as the Canary Islands, this decrease began before the onset of the recession, while in other regions, such as the Basque country, the fertility rate continued to grow until 2011. The effects of the recession on the fertility rate are clearly observed in women aged 30-34 years. CONCLUSIONS: The current economic recession has disrupted the positive trend in fertility that began at the start of this century. Since Spain already had very low fertility rates, the further decline caused by the economic recession could jeopardize the sustainability of welfare-state systems.

An IoT System for Remote Health Monitoring in Elderly Adults Through a Wearable Device and Mobile Application.

With the increase in global life expectancy and the advance of technology, the creation of age-friendly environments is a priority in the design of new products for elderly people healthcare. This paper presents a proposal for a real-time health monitoring system of older adults living in geriatric residences. This system was developed to help caregivers to have a better control in monitoring the health of their patients and have closer communication with their patients' family members. To validate the feasibility and effectiveness of this proposal, a prototype was built, using a biometric bracelet connected to a mobile application, which allows real-time visualization of all the information generated by the sensors (heart rate, body temperature, and blood oxygenation) in the bracelet. Using these data, caregivers can make decisions about the health status of their patients. The evaluation found that the users perceived the system to be easy to learn and use, providing initial evidence that our proposal could improve the quality of the adult's healthcare.

Cognitive Assessment Test: Validation of a Short Cognitive Test for the Detection of Mild Cognitive Disorder.

INTRODUCTION: Cognitive disorders are a clinical and research challenge; in particular, the mild cognitive disorder (MiCD) requires diagnostic suspicion and tools with adequate performance for its detection. The objective of this study was the validation of a short cognitive test (CATest) for the detection of MiCD in population of 50 years or more. METHODS: A diagnostic accuracy study was assembled and performed in a prospective cohort. A consecutive sample of 200 Colombian subjects who represented the whole spectrum of the condition of interest allowed us to reach the objective. Validity was determined by concurrent criteria. The cut points were determined by the ROC curves considering the best overall performance and accuracy of the test. RESULTS: CATest was validated to detection of MiCD at a cut-off point of 18. As a result, scores lower than 18 classified the participants as MiCD. At this cut-off point, CATest showed sensitivity of 84.3% (CI 76 to 90.16), specificity of 71.4% (CI 95% 61.8 to 79.43), positive predictive value of 75% ( 95% CI 66.79 to 82.42), and area under curve AUC 0.8518 (standard error SE 0.0265). DISCUSSION: CATest has an adequate performance as a short cognitive test for the detection of MiCD. Its performance is superior to MiniMental and similar to Montreal Cognitive test (MoCA) according to the data reported in the literature. The advantages over other tests are the evaluation of all cognitive domains, time of application, and easy interpretation of results. CATest is a free use alternative for MiCD detection.

Cost analysis of integrated renal replacement therapy program in the province of Toledo (2012-2013). / Análisis de costes del programa integrado de tratamiento renal sustitutivo en la provincia de Toledo (2012-2013).

BACKGROUND: Renal replacement therapy (RRT) is the object of constant analysis in the search for efficiency and sustainability. OBJECTIVE: To calculate the direct cost of healthcare for the prevalent RRT population in the province of Toledo (2012/2013). METHOD: a) Population: All prevalent patients at some point in RRT in 2012 (669) and in 2013 (682). b) Costs included (€): 1) dialysis procedure; 2) inpatient, outpatient and emergency care, dialysis and non-dialysis related; 3) drug consumption; 4) medical transport. c) Calculation and analysis: The aggregate localized or reconstructed cost of each item was calculated from the individual cost of each patient. Annual cost and cost per patient/year was calculated for the whole RRT and for its subprograms (€). RESULTS: a) Aggregate costs: The total cost of RRT amounted to 15.84 and 15.77 million euros (2012/2013). Dialysis procedures account for 40.2% of the total while the sum of hospital care and drug consumption represents 41.5%. Healthcare for patients on hospital haemodialysis (HHD) and combined haemodialysis (CHD), peritoneal dialysis (PD) and transplant (Tx) accounts for 70.0, 5.0 and 25.0% of the total respectively. b) Patient/year cost: From the number of patients/year provided by each subprogramme, the following values were obtained in 2012/2013: All RRT 26,130/25,379; HHD 49,167/53,289; CHD 44,657/44,971; PD 45,538/51,869 and Tx 10,909/10,984. CONCLUSIONS: Our results are consistent with others published, although our patient/year values are slightly higher, probably because they include elements such as outpatient pharmacy, hospital and medical transport cargo. The growing contribution of Tx to the survival of the whole RRT population contains the overall costs and reduces the patient/year cost, making RRT sustainable.

[Contextual indicators to assess social determinants of health and the Spanish economic recession]. / Indicadores contextuales para evaluar los determinantes sociales de la salud y la crisis económica española.

OBJECTIVE: To provide indicators to assess the impact on health, its social determinants and health inequalities from a social context and the recent economic recession in Spain and its autonomous regions. METHODS: Based on the Spanish conceptual framework for determinants of social inequalities in health, we identified indicators sequentially from key documents, Web of Science, and organisations with official statistics. The information collected resulted in a large directory of indicators which was reviewed by an expert panel. We then selected a set of these indicators according to geographical (availability of data according to autonomous regions) and temporal (from at least 2006 to 2012) criteria. RESULTS: We identified 203 contextual indicators related to social determinants of health and selected 96 (47%) based on the above criteria; 16% of the identified indicators did not satisfy the geographical criteria and 35% did not satisfy the temporal criteria. At least 80% of the indicators related to dependence and healthcare services were excluded. The final selection of indicators covered all areas for social determinants of health, and 62% of these were not available on the Internet. Around 40% of the indicators were extracted from sources related to the Spanish Statistics Institute. CONCLUSIONS: We have provided an extensive directory of contextual indicators on social determinants of health and a database to facilitate assessment of the impact of the economic recession on health and health inequalities in Spain and its autonomous regions.

Coping assessment from the perspective of the person-situation interaction: Development and validation of the Situated Coping Questionnaire for Adults (SCQA).

BACKGROUND: Although coping strategies are considered to contribute to resilience to adversity, their use is not stable, but varies depending on the specific adversity. However, to date, most of the questionnaires assessing coping do not consider its situational character. The objective of this study is to develop and validate the Situated Coping Questionnaire for Adults (SCQA), which assesses coping in the face of five different kinds of adverse contexts to take into account its situational dimension. METHODS: A total of 430 Spanish adults (256 from the general population, 77 people suffering from cancer or HIV, and 97 parents of children with cancer or developmental problems) completed the SCQA and two resilience questionnaires (the Brief Resilience Scale and the 10-item Connor-Davidson Resilience Scale) for validation purposes. RESULTS: Confirmatory factor analyses showed the superiority of the person-situation model; the situation influences the degree to which people use specific coping strategies; however, coping is also stable to some extent. Regression analyses showed that coping strategies contribute to predict resilience, supporting the validity of the SCQA. The questionnaire and its sub-scales showed adequate reliability. CONCLUSION: The SCQA is deemed a reliable and valid means of situated coping assessment for use in several populations.

[Study protocol on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain]. / Protocolo del estudio sobre el efecto de la crisis económica en la mortalidad, la salud reproductiva y las desigualdades en salud en España.

The aim is to present the protocol of the two sub-studies on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain. Substudy 1: describe the evolution of mortality and reproductive health between 1990 and 2013 through a longitudinal ecological study in the Autonomous Communities. This study will identify changes caused by the economic crisis in trends or reproductive health and mortality indicators using panel data (17 Autonomous Communities per study year) and adjusting Poisson models with random effects variance. Substudy 2: analyse inequalities by socioeconomic deprivation in mortality and reproductive health in several areas of Spain. An ecological study analysing trends in the pre-crisis (1999-2003 and 2004-2008) and crisis (2009-2013) periods will be performed. Random effects models Besag York and Mollié will be adjusted to estimate mortality indicators softened in reproductive health and census tracts.

The assessment of generalized anxiety disorder: psychometric validation of the Spanish version of the self-administered GAD-2 scale in daily medical practice.

AIM: To psychometrically validate the Spanish version of the self-administered 2-item GAD-2 scale for screening probable patients with generalised anxiety disorder (GAD). METHODS: The GAD-2 was self-administered by patients diagnosed with GAD according to DSM-IV criteria and by age- and sex-matched controls who were recruited at random in mental health and primary care centres. Criteria validity was explored using ROC curve analysis, and sensitivity, specificity and positive and negative predictive values were determined for different cut-off values. Concurrent validity was also established using the HAM-A, HADS, and WHODAS II scales. RESULTS: The study sample consisted of 212 subjects (106 patients with GAD) with a mean age of 50.38 years (SD = 16.76). No items of the scale were left blank. Floor and ceiling effects were negligible. No patients with GAD had to be assisted to complete the questionnaire. Reliability (internal consistency) was high; Cronbach's α = 0.875. A cut-off point of 3 showed adequate sensitivity (91.5%) and specificity (85.8%), with a statistically significant area under the curve (AUC = 0.937, p < 0.001), to distinguish GAD patients from controls. Concurrent validity was also high and significant with HAM-A (0.806, p < 0.001), HADS (anxiety domain, 0.825, p < 0.001) and WHO-DAS II (0.642, p < 0.001) scales. CONCLUSION: The Spanish version of the GAD-2 scale has been shown to have appropriate psychometric properties to rapidly detect probable cases of GAD in the Spanish cultural context under routine clinical practice conditions.

[Health system interventions assessment in Spain: an approach through the analysis of the time trends and the geographical variability of avoidable mortality between 1986 -2001]. / Medida del resultado de las intervenciones sanitarias en España: una aproximación mediante el análisis temporal y espacial de la mortalidad evitable entre 1986-2001.

BACKGROUND: Many studies have proposed Avoidable Mortality (ME) to monitor the performance of health services although its usefulness is limited by the multiplicity of the avoidable mortality lists being used. Time trends from 1986-2001 and the geographical distribution of avoidable mortality by provinces, are presented for Spain. METHODS: An Avoidable Mortality consensus list is being used. It includes avoidable mortality through the intervention of health services (ISAS in Spanish) and through health policy interventions (IPSI in Spanish). Time trends are analyzed adjusting Poisson or Joinpoint regression models and the annual percentages of change (APC) are estimated. Changes in geographical distribution between the first half of the analysed period and the second are tested by means of standard mortality ratios (SMR) and comparative mortality rates (CMR) for each province. RESULTS: Between 1986 and 2001 avoidable mortality decreased (APC: -1.68; CI: -1.99 and -1.38) slightly more than non-avoidable mortality (APC: -1.28; CI: -1.40 and -1.17). Higher reduction was observed for ISAS mortality (APC: -2.77; CI: -2.89 and -2.65) and an irregular trend for IPSI (between 1986-1990 increase APC: 4.86; CI: 3.32 and 6.41, between 1990-95 stabilization APC: -0.03; CI: -2.32 and 2.31 and finally 1995-2001 decrease APC: -3.57; CI: -4.72 and -2.40). CONCLUSIONS: Avoidable mortality decreased more than non avoidable mortality and important geographical variability can be observed among provinces which should be monitored in order to identify the health services weaknesses. The higher ISAS mortality was observed in southern provinces and the higher IPSI mortality in some areas on the coast. The pattern is somewhat similar for both analyzed periods.

Peso, talla y estado de salud según tipo de lactancia en menores de seis meses de edad que acuden a una unidad de medicina familiar de León, Guanajuato / Weigth, height and health status according type of feeding in 6 months old children. Experience in a primary care clinic in Leon, Guanajuato

Objetivo. Comparar el peso, talla y frecuencia de diarreas e infecciones respiratorias en los menores de seis meses, según el tipo de lactancia en la unidad de medicina familiar No. 47 del Instituto Mexicano del Seguro Social de León, Gto. Material y Métodos. Se realizó un estudio comparativo, longitudinal y prospectivo de enero a junio de 1995, con 204 recién nacidos. De estos se eligieron al azar a 33 que llevaron lactancia materna durante seis meses para compararlos con 78 lactantes que les proporcionaron lactancia materna y/o mixta. Se evaluaron mensualmente a los lactantes, peso, talla, frecuencia de enfermedades respiratorias agudas y diarreas. Resultados. El peso siempre fue mejor en los alimentados con lactancia materna, la talla fue ligeramente menor con una p > 0.05 con una equivalencia de crecimiento y nutrición mejores que el grupo alimentado con lactancia artificial p>0.05. La frecuencia de infecciones respiratorias y diarreicas son mayores en los lactantes que reciben otro tipo de lactancia p=0.01. Conclusiones. La promoción del uso de lactancia materna debe de continuar en todas las instituciones de salud para disminuir el número de infecciones respiratorias y de diarreas. El disminuir la frecuencia de estas enfermedades, también disminuyen las cifras de mortalidad en los menores de seis meses