Leovigildo Ginel Mendoza
@juntadeandalucia.es
Servicio Andaluz De Salud
Scopus Publications
Scopus Publications
A.A. Romero-Secin, J. Díez-Espino, M.A. Prieto-Díaz, V. Pallares-Carratala, A. Barquilla-García, R.M. Micó-Pérez, J. Polo-García, S.M. Velilla-Zancada, V. Martín-Sanchez, A. Segura-Fragoso,et al.
Elsevier BV
L. Ginel Mendoza, J. Gonzálvez Rey, J.A. Trigueros Carrero, and P. Piñera Salmerón
Elsevier BV
Miguel A. Prieto-Díaz, Vicente Pallares-Carratala, Rafael Manuel Micó-Pérez, Carlos Escobar-Cervantes, Vicente Martín-Sanchez, Antonio Coca, Alfonso Barquilla-García, Sonsoles M. Velilla-Zancada, José Polo-García, Antonio Segura-Fragoso,et al.
Frontiers Media SA
ObjectivesTo determine the clinical profile, according to the history of hypertension, the risk of developing hypertension, current antihypertensive treatment and BP control rates in patients with hypertension from the IBERICAN cohort.MethodsIBERICAN is an ongoing prospective cohort study, whose primary objective is to determine the frequency, incidence, and distribution of CVRF in the adult Spanish population seen in primary care settings. This analysis shows the baseline clinical characteristics of patients with hypertension. Adequate BP control was defined as BP <140/90 mmHg according to 2013 ESH/ESC guidelines.ResultsA total of 8,066 patients were consecutively included, of whom 3,860 (48.0%) had hypertension. These patients were older (65.8 ± 10.9 vs. 51.6 ± 14.7 years; p < 0.001), had more cardiovascular risk factors, target organ damage and cardiovascular disease (CVD) in comparison with those without hypertension. The risk of hypertension increased with the presence of associated CV risk factors and comorbidities, particularly diabetes, obesity and the metabolic syndrome, and decreased with the intensity of physical activity. Regarding antihypertensive treatments, 6.1% of patients did not take any medication, 38.8% were taking one antihypertensive drug, 35.5% two drugs, and 19.6% three or more antihypertensive drugs. Overall, 58.3% achieved BP goals <140/90 mmHg. A greater probability of BP control was observed with increasing age of patients and the greater number of antihypertensive drugs. Blood pressure control was lower in hypertensive patients with diabetes, obesity, the metabolic syndrome, increased urinary albumin excretion, higher pulse pressure, and lack of antihypertensive treatment.ConclusionsAbout half of patients attended in primary care settings have hypertension in Spain. Patients with hypertension have a worse CV clinical profile than non-hypertensive patients, with greater association of CVRF and CVD. Around four out of ten patients do not achieve the recommended BP goals, and higher use of combination therapies is associated with a better BP control.
Paula Antelo-Pais, Miguel Ángel Prieto-Díaz, Rafael M. Micó-Pérez, Vicente Pallarés-Carratalá, Sonsoles Velilla-Zancada, José Polo-García, Alfonso Barquilla-García, Leovigildo Ginel-Mendoza, Antonio Segura-Fragoso, Facundo Vitelli-Storelli,et al.
MDPI AG
The role of uric acid levels in the cardiovascular continuum is not clear. Our objective is to analyze the prevalence of hyperuricemia (HU) and its association with cardiovascular risk factors (CVRF), subclinical target organ damage (sTOD), and cardiovascular diseases (CVD). We evaluated the prevalence of HU in 6.927 patients included in the baseline visit of the IBERICAN study. HU was defined as uric acid levels above 6 mg/dL in women, and 7 mg/dL in men. Using adjusted logistic regression models, the odds ratios were estimated according to CVRF, sTOD, and CVD. The prevalence of HU was 16.3%. The risk of HU was higher in patients with pathological glomerular filtration rate (aOR: 2.92), heart failure (HF) (aOR: 1.91), abdominal obesity (aOR: 1.80), hypertension (HTN) (aOR: 1.65), use of thiazides (aOR: 1.54), left ventricular hypertrophy (LVH) (aOR: 1.36), atrial fibrillation (AFIB) (aOR: 1.29), and albuminuria (aOR: 1.27). On the other hand, being female (aOR: 0.82) showed a reduced risk. The prevalence of HU was higher in men, in patients presenting CVRF such as HTN and abdominal obesity, and with co-existence of LVH, atrial fibrillation (AFIB), HF, and any form of kidney injury. These associations raise the possibility that HU forms part of the early stages of the cardiovascular continuum. This may influence its management in Primary Healthcare because the presence of HU could mean an increased CV risk in the patients.
Isabel del Cura-González, Juan A. López-Rodríguez, Francisca Leiva-Fernández, Luis A. Gimeno-Feliu, Victoria Pico-Soler, Mª. Josefa Bujalance-Zafra, Miguel Domínguez-Santaella, Elena Polentinos-Castro, Beatriz Poblador-Plou, Paula Ara-Bardají,et al.
Springer Science and Business Media LLC
Abstract Background The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. Objective To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/design This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population Patients aged 65–74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included. Sample size n = 1148 patients (574 per study arm). Intervention Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. Statistical analysis The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. Discussion It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. Trial registration ClinicalTrials.gov NCT04147130. Registered on 22 October 2019
Fernando Cantalapiedra Fernández, Dolores Rico Munilla, Raúl de Simón Gutiérrez, Leovigildo Ginel Mendoza, and Antonio Hidalgo Requena
Edittec
R. de Simón Gutiérrez, L. Ginel Mendoza, A. Hidalgo Requena, D. Rico Munilla, and F. Cantalapiedra Fernández
Elsevier BV
OBJECTIVES
To assess users' attitudes and knowledge of users about how and where inhalers are removed after finalizing their use, and to describe their opinion about utilizing re-usable inhalers.
METHODS
Cross-sectional, multi-center, and opinion survey, conducted to assess behavior and attitudes regarding the disposal of inhalers recycling and the use of re-usable inhalers, through the application of an ad hoc questionnaire about the knowledge and attitudes, with data about the use and recycling of inhalers.
RESULTS
A total of 303 subjects (57.5±19.9 years; time of inhalers' use 9.6±9.8 years; asthma/COPD: 46.2%/25.7%) were included. Pressurized metered-dose inhalers were the most commonly used inhalers (30.5%). Most users considered the recycling of inhalers to be very important (7.75±2.76, out of 10), and rated highly the availability of having a monthly rechargeable inhaler every 6 months (7.77±2.79, out of 10). Only 33% of users had been informed by their healthcare professionals about the place of delivering the inhaler. With respect to recycling, 42.9% of all users recycled in the SIGRE point of the pharmacy. Regarding the final destination of inhalers, 43.6% thought that the removed inhalers were recycled or destroyed, but 35.3% did not know what would happen to the inhalers after placing in the SIGRE point.
CONCLUSIONS
Despite users considered the importance of inhalers recycling and the availability of re-usable inhalers, a significant proportion does not recycle in the SIGRE point, has not been informed about the appropriate place of delivering the inhaler and ignores what happens to inhalers. Information campaigns are warranted.
Leovigildo Ginel-Mendoza, Alfonso Hidalgo-Natera, Rocío Reina-Gonzalez, Rafael Poyato-Ramos, Juana Morales-Naranjo, Inmaculada Lupiañez-Pérez, Antonio Baca-Osorio, Miguel Gutiérrez-Jansen, María Paz Fernández-Lara, Diego Lozano-Noriega,et al.
Springer Science and Business Media LLC
Abstract Background Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin time using the international normalized ratio. If its values are out of the recommended range, the patient will have a higher risk of suffering from thromboembolic or hemorrhagic complications. Previous research has shown that approximately 33% of patients keep having values at an inappropriate level. The purpose of the proposed study is to improve the international normalized ratio control results by a joint didactic intervention based on the Junta de Andalucía School for Patients method that will be implemented by anticoagulated patients themselves. Methods A randomized controlled trial will be undertaken at primary care centers from one healthcare area in Málaga (Andalusia, Spain). Study population: patients participating in an oral anticoagulant therapy program of vitamin K antagonists. First step: identification of patients in the oral anticoagulation therapy program with international normalized ratio control of the therapeutic level at 65% or less over total time. Second step: patients with international normalized ratio (INR) control figures under 2 or above 3 will be assigned to two different groups: Group 1 or joint intervention group: patients will be instructed in the joint didactic “from peer to peer,” by a previously trained and expert anticoagulant patient. Group 2 or control group: the control group will receive the usual clinical practice. They will be evaluated by nurses about once a month, except for cases in which their INR figures are under 2 or above 3, and those patients will be evaluated more frequently. A total of 312 individuals will be required (156 in each group) to detect differences in INR figures equal to or higher than 15% between the groups. Study variables: time on therapeutic levels before and after the intervention; sociodemographic variables; vital signs; the existence of cardiovascular risk factors or accompanying diseases in the clinical records; laboratory test including complete blood counts, bleeding time, and prothrombin time or partial thromboplastin time; and blood chemistry, other prescribed drugs, and social support. A quasi-experimental analytic study with before-after statistical analysis of the intervention will be conducted. Linear regression models will be applied for the main variable results (international normalized ratio value, time on therapeutic level) inputting sociodemographic variables, accompanying diseases, and social support. Trial registration ClinicalTrials.gov NCT03647254. Registered on 27 August 2018
Miguel Román Rodríguez, Leovigildo Ginel Mendoza, Marina Blanco Aparicio, Mercedes Rodríguez Rodríguez, and Mario Bárcena Caamaño
Elsevier BV
Asthma is one of the most prevalent diseases in Spain, yet despite the great diagnostic and therapeutic advances made in this field, health outcomes suggest that up to 80% of patients do not have their asthma well controlled. Although the causes of this situation are diverse, there are some practices among the professionals who treat asthma that are not conducive to improving health outcomes in this disease. Our working group has prepared this document in order to remind clinicians of a series of basic guidelines, aligned with current guidelines and recent literature, and agreed by a multidisciplinary expert panel using Delphi methodology. These recommendations about what not to do in the management of asthma in the adult patient are structured into four areas: diagnosis, monitoring, treatment and prevention of exacerbations.
Sara Manrique-Arija, Natalia Mena-Vazquez, Inmaculada Ureña, José Rioja, Pedro Valdivielso, Leovigildo Ginel-Mendoza, Salomé Abad-Sánchez, Francisco G Jiménez-Núñez, Begoña Oliver-Martos, and Antonio Fernandez-Nebro
BMJ
ObjectivesTo describe the prevalence of insulin resistance (IR) in patients with established rheumatoid arthritis (RA) and to analyse the contribution of cumulative inflammatory burden and other factors to its development.DesignObservational cross-sectional study.ParticipantsPatients with RA and controls matched for age, sex and Body Mass Index. We excluded patients with diabetes.SettingsPatients from an RA inception cohort at Hospital Regional Universitario de Málaga, Spain, were recruited between September 2016 and May 2018.Primary and secondary outcome measuresIR was evaluated using the homeostasis model assessment for IR and beta-cell function and the quantitative insulin sensitivity check index. Other variables included the cumulative 28-Joint Disease Activity Score (DAS28) with C reactive protein (CRP) body composition and cytokines. Two logistic regression models were constructed to identify factors associated with IR in patients with RA.ResultsEighty-nine patients with RA and 80 controls were included. The prevalence of IR was similar in both cases and controls. Inflammatory activity was controlled appropriately in patients during follow-up (mean DAS28 3.1 (0.8)). The presence of IR in patients with RA was associated with obesity (OR 6.01, 95% CI 1.9 to 8.7), higher cumulative DAS28-CRP values during follow-up (OR 2.8, 95% CI 1.3 to 6.0), and higher interleukin-1β levels (OR 1.6, 95% CI 1.1 to 2.4). The second model showed that the risk of IR increased by 10% for each kilogram of excess body fat.ConclusionIn patients with well-controlled, established RA, IR is associated mainly with poorer control of inflammation from diagnosis and with obesity, specifically total fat mass.
J. Domínguez-Ortega, F.J. Sáez-Martínez, J.T. Gómez-Sáenz, J. Molina-París, F.J. Álvarez-Gutiérrez, Francisco Álvarez Gutiérrez, Mario Bárcena Caamaño, Marina Blanco Aparicio, Julio Delgado Romero, Javier Domínguez Ortega,et al.
Elsevier BV
Asthma is the most prevalent respiratory disease worldwide and it can affect people of all ages and is potentially fatal. Today, maintenance treatments are available that are effective in most patients, yet a significant proportion have poorly controlled disease, despite the resources on offer. This document, endorsed by members of the Spanish medical societies involved in the treatment of asthma, is intended to draw the attention of society and professionals to this problem in Spain. It focuses on the clinical, diagnostic and therapeutic aspects of asthma, and proposes some actions for improvement as regards patients and healthcare professionals which, in view of the current results arising from inadequate asthma control, might be beneficial to improve outcomes for both patients and public health.
J.T. Gómez Sáenz, M.J. Gérez Callejas, A. Hidalgo Requena, L. Ginel Mendoza, J. González Aguilera, and J.A. Quintano Jiménez
Elsevier BV
Resumen Introduccion El asma es un importante problema de salud publica que afecta a mas de 300 millones de personas en el mundo. La importancia de una enfermedad se puede medir por su prevalencia, la carga asistencial, la morbimortalidad. Objetivos Conocer la carga asistencial o la morbimortalidad por asma en Espana en el periodo 1990-2015. Material y metodos Se han obtenido del Instituto Nacional de Estadistica el numero de defunciones atribuidas al asma por sexo y grupos quinquenales junto con la poblacion a 1 de julio entre los anos 1990-2015. A partir de los datos se calcula la tasa de mortalidad bruta por 100.000 habitantes globales, por sexo y grupos etarios. Resultados En 2015 fallecieron en Espana con diagnostico de asma como causa principal 1.134 personas (195 varones y 939 mujeres), con tasas del 0,82/100.000 habitantes frente a 2,58, respectivamente. Las tasas de mortalidad por asma en Espana se mantienen estables en los ultimos 25 anos y son ligeramente superiores a las de los paises de nuestro entorno. Mientras que la mortalidad por asma ha disminuido en varones mas de un 67%, se han incrementado en un 32% en las mujeres. Los fallecimientos se concentran en mayores de 65 y sobre todo 80 anos en los que el valor de los certificados de defuncion es mas limitado. La mortalidad en los grupos de 5-35 anos esta entre las mas bajas de Europa.
María José Bujalance-Zafra, Miguel Domínguez-Santaella, Antonio Baca-Osorio, Leovigildo Ginel-Mendoza, Francisco Jesús Fernández-Vargas, and Rafael Poyato-Ramos
Elsevier BV
Resumen Objetivo Analizar la efectividad de una intervención en profesionales sanitarios de atención primaria (AP) en la mejora de resultados de salud de pacientes agudizadores de EPOC (AEPOC). Diseño Observacional, con análisis retrospectivo y prospectivo. Emplazamiento Distrito Sanitario Málaga-Guadalhorce (DSMG). Participantes Pacientes EPOC agudizados atendidos por los dispositivos móviles de urgencias del DSMG (n = 523; 21% pérdidas). Intervenciones Formación a los profesionales en la práctica clínica habitual e inclusión de indicadores de proceso de EPOC en objetivos ligado a incentivos. Mediciones principales Comparación de variables de proceso y de resultado mediante auditoría de la historia clínica. Variable respuesta: diferencia de agudizaciones en 2 periodos analizados. Análisis bivariante y multivariante. Resultados Edad media 75 (± 9,3) años; varones 63,7%, con un IMC de 29,4 (± 7,1); fumadores activos 21%. El FEV1 medio fue del 48,2% (± 18,7). La media de agudizaciones en el primer período fue de 2,86 (± 2,29) y en el segundo, de 1,36 (± 1,56) (p < 0,001). La media de ingresos en el primer y segundo periodos fue 0,56 (± 0,94) y 0,31 (± 0,66) (p < 0,001), respectivamente. La disminución del número de agudizaciones se relacionó de forma directa con haber tenido ≥ 2 agudizaciones en el primer período, exacerbación revisada en atención primaria y de forma inversa con tener insuficiencia cardiaca y ≥ 2 agudizaciones en el segundo período (coeficiente de determinación R2 = 0,28; p < 0,001). Conclusiones El número de agudizaciones y de ingresos entre ambos periodos evaluados disminuyó significativamente. Sin embargo, no mejoraron los indicadores de proceso evaluados. Se precisan estudios prospectivos de intervención para establecer la posible relación causal.
A. Viejo-Casas, C. Bonnardeaux-Chadburn, L. Ginel-Mendoza, and J.A. Quintano-Jimenez
Elsevier BV
Knowledge of chronic obstructive pulmonary disease has increased significantly in recent years, and today we have a more comprehensive concept of the disease. Additionally, drug development allows having a wide range of therapeutic options. The inhaled route is the choice, as it allows drugs to act directly on the bronchial tree. In the past few months, new molecules and devices have been developed that increases our options when treating, but also our doubts when choosing one or the other, so an update of inhaled medications for chronic obstructive pulmonary disease is necessary. The different types of inhalers currently available are reviewed in this article, as well as the advantages and disadvantages of each of them, in order to determine how to choose the right device.
A.J. García-Ruiz, J.A. Quintano Jiménez, N. García-Agua Soler, L. Ginel Mendoza, A. Hidalgo Requena, and F. del Moral
Elsevier BV
AIM
To perform a cost-utility analysis on asthmatic patients on beclomethasone/formoterol fixed combination in Primary Health Care. Material and methods Non-probability sampling was used to select a group of asthmatic patients with moderate/severe persistent severity (GEMA 2009), treated with beclomethasone/formoterol fixed combination, over 18 years, had given their informed consent. The study observation period was 6 months. The variables studied were: age, sex, duration of disease, health resources used, analysis of health related quality of life by EQ-5D and SF-36, and the specific Asthma Quality of Life Questionnaire. For the qualitative variables, the frequency and percentages were calculated, and for the quantitative variables, the mean, SD and 95% CI. Chi-square, Student t-test and ANOVA were used for statistical inference. Comparisons were made with a statistical significance of 0.05.
RESULTS
Of the 64 patients that completed the study, 59.4% were female. The mean age was 49 years, and mean disease duration was 93 months. For asthma control, 53% of patients had a prescription pattern of one/12h. All health related quality of life scales were modified with respect to the baseline and the differences were statistically significant. Our patients had a better health related quality of life than Spanish asthma cohort. The incremental cost utility beclomethasone/formoterol versus usual treatment option was € 6,256/QALY.
Vicente Plaza, Concepción Fernández-Rodríguez, Carlos Melero, Borja G. Cosío, Luís Manuel Entrenas, Luis Pérez de Llano, Fernando Gutiérrez-Pereyra, Eduard Tarragona, Rosa Palomino, Antolín López-Viña,et al.
Mary Ann Liebert Inc
Abstract Background: To validate the ‘Test of Adherence to Inhalers’ (TAI), a 12-item questionnaire designed to assess the adherence to inhalers in patients with COPD or asthma. Methods: A total of 1009 patients with asthma or COPD participated in a cross-sectional multicenter study. Patients with electronic adherence ≥80% were defined as adherents. Construct validity, internal validity, and criterion validity were evaluated. Self-reported adherence was compared with the Morisky-Green questionnaire. Results: Factor analysis study demonstrated two factors, factor 1 was coincident with TAI patient domain (items 1 to 10) and factor 2 with TAI health-care professional domain (items 11 and 12). The Cronbach's alpha was 0.860 and the test-retest reliability 0.883. TAI scores correlated with electronic adherence (ρ=0.293, p=0.01). According to the best cut-off for 10 items (score 50, area under the ROC curve 0.7), 569 (62.5%) patients were classified as non-adherents. The non-adherence behavior pattern was: erratic 527 (57.9%), deliberate 375 (41.2%), and unwitting 242 (26.6%) patients. As compared to Morisky-Green test, TAI showed better psychometric properties. Conclusions: The TAI is a reliable and homogeneous questionnaire to identify easily non-adherence and to classify from a clinical perspective the barriers related to the use of inhalers in asthma and COPD.
J.A. Quintano Jiménez, L. Ginel Mendoza, L.M. Entrenas Costa, and J. Polo García
Elsevier BV
Resumen La combinacion a dosis fija de fluticasona propionato/formoterol es una nueva combinacion de un glucocorticoide inhalado y un agonista β2-adrenergico de accion larga ampliamente conocidos y utilizados, disponibles por primera vez en un mismo dispositivo. Esta combinacion a dosis fija de fluticasona propionato/formoterol ha demostrado su perfil de eficacia y seguridad en distintos ensayos clinicos frente a sus componentes individuales y otras combinaciones a dosis fijas de glucocorticoide inhalado/agonista β2-adrenergico de accion larga, y esta indicada para el tratamiento del asma persistente en adultos y adolescentes. Fluticasona propionato/formoterol esta disponible en un amplio rango de dosis, que permite cubrir adecuadamente los escalones terapeuticos recomendados por las guias terapeuticas, y constituye una combinacion a dosis fija de glucocorticoide inhalado/agonista β2-adrenergico de accion larga eficaz, rapida, bien tolerada y con un coste de adquisicion razonable. Esta combinacion ha sido posicionada por los distintos organismos evaluadores de las comunidades autonomas como alternativa terapeutica adecuada para el asma en el ambito de la atencion primaria.
P. Martín-Pérez, J. Quintano-Jiménez, A. Hidalgo-Requena, and L. Ginel-Mendoza
Elsevier BV
Inmaculada Lupiáñez-Pérez, Juan Morilla-Herrera, Leovigildo Ginel-Mendoza, Francisco Martín-Santos, Francisco Navarro-Moya, Rafaela Sepúlveda-Guerra, Rosa Vázquez-Cerdeiros, Magdalena Cuevas-Fernández-Gallego, Isabel Benítez-Serrano, Yolanda Lupiáñez-Pérez,et al.
Springer Science and Business Media LLC
BackgroundPressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment.Methods/designThe main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student’s t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis.DiscussionThe regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment.Trial registrationClinicaltrials.gov identifier: NCT01595347.
Francisco M Kovacs, Joan Bagó, Ana Royuela, Jesús Seco, Sergio Giménez, Alfonso Muriel, Víctor Abraira, José Luis Martín, José Luis Peña, Mario Gestoso,et al.
Springer Science and Business Media LLC
BackgroundThe NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ).MethodsTranslation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed.ResultsComprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability: [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. Validity: Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15.ConclusionAlthough most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance.Trial RegistrationClinical Trials Register NCT00349544.
Enrique Batlle-Gualda, Loreto Carmona, Diana Gavrila, Emilio Ildefonso García Criado, Raquel Ruiz Miravalles, and Jordi Carbonell Abelló
Elsevier BV
OBJECTIVE
The ArtRoCad study analyzes healthcare resource utilization and the socioeconomic impact of knee and hip osteoarthritis in primary care in Spain. The present study describes the methodology of the ArtRoCad study and presents the main characteristics of the population included.
METHODS
We performed a cross-sectional study of ambulatory patients in primary care, aged ≥ 50 years old, with a diagnosis of knee or hip osteoarthritis and a history of pain for 3 months in the previous year. The patients were selected consecutively on a country-wide basis, proportional to the general population aged ≥ 50 years. The most important localization for healthcare demand was considered the main affected joint. The study was performed in October and November, 2003. Information on clinical data, quality of life and resource consumption, sick leave from work or days of disability in the previous 6 months were gathered through 2 structured interviews.
RESULTS
Eighty-seven percent of the physicians predicted by sampling participated in the study, accounting for 82% of the predetermined sample size. A total of 1,071 patients were interviewed. The distribution of the main affected joint was as follows: knee 710 (66.3%), hip 252 (23.5%) and both knee and hip 109 (10.2%). Seventy-five percent of the sample was aged 65 years or older and 74% were women. Most of the patients had moderate or severe osteoarthritis with a median pain duration of between 6 and 10 years. More than half the patients experienced additional limitations due to musculoskeletal problems other than knee and/or hip osteoarthritis.
CONCLUSIONS
Participation in the ArtRoCad study was excellent. The sample obtained was representative of the population with symptomatic moderate or severe osteoarthritis of the knee and hip in primary care, with substantial comorbidity.