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1.
Front Cardiovasc Med ; 10: 1295174, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38173815

RESUMO

Objectives: To 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. Methods: IBERICAN 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. Results: A 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. Conclusions: About 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.

2.
Farm. comunitarios (Internet) ; 14(2): 34-39, abril 2022. tab
Artigo em Espanhol | IBECS | ID: ibc-207130

RESUMO

Objetivo: describir el grado de conocimiento que poseen los usuarios de medicamentos inhalados, respecto al correcto reciclaje de los mismos, indagando cómo y por quién han recibido dicha información y su conocimiento sobre la importancia de los inhaladores recargables. Métodos: estudio epidemiológico, observacional, transversal y multicéntrico realizado en 22 farmacias comunitarias de la Comunidad Autónoma de Madrid. Se diseñó un cuestionario de conocimiento y actitudes sobre el uso y reciclado de inhaladores en pacientes mayores de edad en tratamiento con los mismos.Resultados: desde 22 farmacias comunitarias se incluyeron a 303 sujetos (edad media 57,5±19,9 años; 46,7 % varones; tiempo medio de uso de inhaladores 9,6±9,8 años; motivo de uso: asma: 46,2 %, EPOC: 25,7 %). El 66,2 % y el 67,5 % de los usuarios otorgan una elevada importancia al reciclado de inhaladores y a disponer del mismo inhalador recargable mensualmente cada 6 meses, respectivamente. En cuanto al reciclado, el 42,9 % de los usuarios lo hacía en el punto SIGRE de la farmacia. Solo el 33 % refería haber sido informado alguna vez sobre dónde depositar el inhalador y, en este caso, era el farmacéutico el que lo indicaba en la mayoría de las ocasiones (76,3 %).Conclusiones: a pesar de que la mayoría de los usuarios considera que es importante el reciclado de inhaladores, y de disponer de inhaladores recargables, sólo un tercio refiere haber sido informados sobre el sitio de depósito. Son necesarias campañas de información acerca de la importancia del reciclado de inhaladores y de cómo hacerlo. En este contexto, el farmacéutico comunitario jugaría un papel esencial. (AU)


Objectives: To ascertain where and how inhalers were removed after finalizing their use, and todetermine how the information about recycling was received, as well as the importance of having reusableinhalers.Methods: Epidemiological, observational, cross-sectional and multicenter study performed in thecommunity pharmacies of the Autonomous Community of Madrid, through the application of a voluntaryand anonymous questionnaire that analyzed the knowledge and attitudes regarding the recycling ofinhalers among adult users treated with inhalers.Results: From 22 community pharmacies, a total of 303 subjects (mean age 57.5±19.9 years; 46.7%men; mean time of inhalers` use 9.6±9.8 years; reason for use: asthma: 46.2%, COPD: 25.7%) were included.Overall, 66.2% and 67.5% of users gave a high importance to the recycling of inhalers and the availabilityof having a monthly rechargeable inhaler every 6 months, respectively. With regard to recycling, 42.9% ofusers recycled in the SIGRE point of the pharmacy. Only 33% of users had been informed about the placeof delivering the inhaler, and in this context, in most cases this was performed by the pharmacist (76.3%).Conclusions: Despite the majority of users consider that it is important the recycling of inhalersand the availability of re-usable inhalers, only one third refer having been informed about the place ofdelivering the inhaler. Information campaigns about the importance of recycling of inhalers and how to doit are warranted. In this setting, the community pharmacist could play a key role. (AU)


Assuntos
Humanos , Farmácias , Nebulizadores e Vaporizadores , Pacientes , Inquéritos e Questionários
3.
J Clin Med ; 12(1)2022 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-36614852

RESUMO

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.

4.
Aten. prim. (Barc., Ed. impr.) ; 53(7): 102101, Ago - Sep 2021. tab
Artigo em Espanhol | IBECS | ID: ibc-208155

RESUMO

El asma es una de las enfermedades más prevalentes en España y, a pesar de los grandes avances diagnósticos y terapéuticos, los resultados en salud indican que hasta el 80% de los pacientes no tendrían su asma bien controlada. Aunque las causas de esta situación son diversas, existen algunas prácticas entre los profesionales que atienden el asma que no contribuyen a la mejora de los resultados en salud de esta enfermedad. Nuestro grupo de trabajo ha elaborado este documento para recordar una serie de pautas básicas, alineadas con las guías actuales y la literatura reciente, y consensuadas mediante metodología Delphi por un panel experto multidisciplinar. Estas recomendaciones sobre quéno se debe hacer en el manejo del asma en el adulto quedan articuladas en 4 ámbitos: el diagnóstico, el seguimiento, el tratamiento y la prevención de exacerbaciones.(AU)


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.(AU)


Assuntos
Humanos , Masculino , Feminino , Asma/tratamento farmacológico , Asma/terapia , Consenso , Conhecimentos, Atitudes e Prática em Saúde , Guias de Prática Clínica como Assunto , Comunicação Interdisciplinar , Asma/diagnóstico , Asma/prevenção & controle , Espanha , Atenção Primária à Saúde
5.
Aten Primaria ; 53(7): 102101, 2021.
Artigo em Espanhol | MEDLINE | ID: mdl-34029773

RESUMO

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.


Assuntos
Asma , Médicos , Asma/diagnóstico , Asma/tratamento farmacológico , Consenso , Técnica Delphi , Humanos , Espanha
6.
BMJ Open ; 11(2): e044749, 2021 02 09.
Artigo em Inglês | MEDLINE | ID: mdl-33563625

RESUMO

OBJECTIVES: To 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. DESIGN: Observational cross-sectional study. PARTICIPANTS: Patients with RA and controls matched for age, sex and Body Mass Index. We excluded patients with diabetes. SETTINGS: Patients from an RA inception cohort at Hospital Regional Universitario de Málaga, Spain, were recruited between September 2016 and May 2018. PRIMARY AND SECONDARY OUTCOME MEASURES: IR 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. RESULTS: Eighty-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-1ß 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. CONCLUSION: In patients with well-controlled, established RA, IR is associated mainly with poorer control of inflammation from diagnosis and with obesity, specifically total fat mass.


Assuntos
Artrite Reumatoide , Resistência à Insulina , Artrite Reumatoide/complicações , Artrite Reumatoide/epidemiologia , Estudos Transversais , Humanos , Obesidade/complicações , Obesidade/epidemiologia , Espanha/epidemiologia
7.
Trials ; 22(1): 45, 2021 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-33430922

RESUMO

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.


Assuntos
Anticoagulantes , Instituições Acadêmicas , Anticoagulantes/efeitos adversos , Humanos , Coeficiente Internacional Normatizado , Tempo de Protrombina , Ensaios Clínicos Controlados Aleatórios como Assunto , Espanha
8.
Gerokomos (Madr., Ed. impr.) ; 31(1): 32-35, mar. 2020. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-192210

RESUMO

Paciente de 79 años, remitida a consulta de enfermería para valoración de lesión postraumática en miembro inferior derecho de una semana de evolución, tratada con vendaje elástico y heparina de bajo peso molecular. OBJETIVO: Conocer el rol de la enfermería en la prevención y tratamiento de la dermatoporosis, a propósito de un caso clínico. METODOLOGÍA: Caso clínico con planteamiento metodológico, con consentimiento informado de la paciente y fotografías del caso. RESULTADO: La cicatrización se consiguió en un periodo de 65 días, con una correcta preparación del lecho de la herida para el posterior éxito del injerto cutáneo, controlando el edema, exudado y dolor durante las curas, realizadas cada 2-3 días de acuerdo con la efectividad del tratamiento. DISCUSIÓN: La dermatoporosis exige un mayor esfuerzo en prevención primaria y secundaria desde Atención Primaria, sobre todo a partir de la detección de las manifestaciones clínicas y complicaciones iniciales derivadas de la misma


A 79-year-old patient referred to a nursing consultation to evaluate a traumatic lesion in the right lower limb for one week, treated with elastic bandage and low molecular weight heparin. OBJECTIVE: Knowing the role of nursing in the prevention and treatment of dermatoporosis, in relation to a clinical case. METHODOLOGY: Clinical case with methodological approach, with informed consent of the patient and photographs. RESULT:The healing was achieved in a period of 65 days, with a correct preparation of the wound bed for the subsequent success of the skin graft, treating the edema, exudate and pain during the cures, made every 2-3 days in accordance with the effectiveness of the treatment. DISCUSSION: Dermatoporosis requires a greater effort in primary and secondary prevention from primary care, especially from the detection of clinical manifestations and initial complications derived from it


Assuntos
Humanos , Feminino , Idoso , Envelhecimento da Pele/patologia , Diagnóstico de Enfermagem/métodos , Transplante de Pele/métodos , Desbridamento/métodos , Extremidade Inferior/patologia , Cicatrização , Transplante de Pele/enfermagem , Transplante de Pele/reabilitação
9.
Aten. prim. (Barc., Ed. impr.) ; 49(2): 102-110, feb. 2017. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-160460

RESUMO

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


OBJECTIVE: To examine the impact of an intervention by Primary Care (PC) professionals of a Health District on the clinical outcomes for treating COPD exacerbations using a process and outcome indicators analysis (clinical audit). DESIGN: Observational, retrospective and prospective analysis cross-sectional audit of clinical practice. SETTING: Malaga-Guadalhorce Sanitary District (DSMG). Participants. Patients with COPD exacerbations treated by the extra-hospital emergency services (n = 523; 21% losses). INTERVENTIONS: Professional training in the usual clinical practice and inclusion of process indicators of COPD targets in relation to incentives. Principal measurements. Comparison of external audit results (process and outcomes variables) from medical records and Health Outcomes (exacerbations, admissions). Variable response: Difference in exacerbations and admissions in 2 periods analysed. Bivariate and multivariate analysis. RESULTS: Mean age was 75 (± 9.3), 63.7% males with a BMI of 29.4 (±7.1), and 21% active smokers. Mean FEV1, 48.2% (± 18.7). Mean exacerbations in the first period, 2.86 (± 2.29) and in the second 1.36 (± 1.56) (P <. 001). Mean hospital admissions in the first and second period, 0.56 (±0.94) and 0.31 (± 0.66) (P < .001), respectively. The decrease in the number of exacerbations was directly associated with having ≥ 2 exacerbations in the first period, reviewed in Primary Care, and inversely with heart failure and with having ≥ 2 exacerbations in the second period (R2 = 0.28; P < .001). CONCLUSIONS: The number of exacerbations and admissions decreased significantly in both periods assessed. However, the evaluated process indicators did not improve. Prospective intervention studies are necessary to establish the possible causal relationshi


Assuntos
Humanos , Masculino , Feminino , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/prevenção & controle , Atenção Primária à Saúde/métodos , Atenção Primária à Saúde/tendências , Exacerbação dos Sintomas , Estudos Retrospectivos , Estudos Prospectivos , Aplicativos Móveis
10.
Aten Primaria ; 49(2): 102-110, 2017 Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-27692653

RESUMO

OBJECTIVE: To examine the impact of an intervention by Primary Care (PC) professionals of a Health District on the clinical outcomes for treating COPD exacerbations using a process and outcome indicators analysis (clinical audit). DESIGN: Observational, retrospective and prospective analysis cross-sectional audit of clinical practice SETTING: Malaga-Guadalhorce Sanitary District (DSMG). PARTICIPANTS: Patients with COPD exacerbations treated by the extra-hospital emergency services (n=523; 21% losses). INTERVENTIONS: Professional training in the usual clinical practice and inclusion of process indicators of COPD targets in relation to incentives. PRINCIPAL MEASUREMENTS: Comparison of external audit results (process and outcomes variables) from medical records and Health Outcomes (exacerbations, admissions). Variable response: Difference in exacerbations and admissions in 2 periods analysed. Bivariate and multivariate analysis. RESULTS: Mean age was 75 (±9.3), 63.7% males with a BMI of 29.4 (±7.1), and 21% active smokers. Mean FEV1, 48.2% (±18.7). Mean exacerbations in the first period, 2.86 (±2.29) and in the second 1.36 (±1.56) (P<.001). Mean hospital admissions in the first and second period, 0.56 (±0.94) and 0.31 (±0.66) (P<.001), respectively. The decrease in the number of exacerbations was directly associated with having ≥2 exacerbations in the first period, reviewed in Primary Care, and inversely with heart failure and with having ≥2 exacerbations in the second period (R2=0.28; P<.001) CONCLUSIONS: The number of exacerbations and admissions decreased significantly in both periods assessed. However, the evaluated process indicators did not improve. Prospective intervention studies are necessary to establish the possible causal relationship.


Assuntos
Atenção Primária à Saúde , Doença Pulmonar Obstrutiva Crônica/terapia , Doença Aguda , Idoso , Progressão da Doença , Feminino , Humanos , Masculino , Estudos Prospectivos , Melhoria de Qualidade , Estudos Retrospectivos
12.
Rheumatol Int ; 34(6): 823-32, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24362751

RESUMO

Hip and knee osteoarthritis (OA) is a common cause of disability, with great quality of life and economic impact, hence the need for effective treatment. Patient satisfaction with treatment is a measure of therapeutic effectiveness and may be used to assess treatment switch in OA patients. A 3-month multicenter, prospective, epidemiologic, non-interventional study was conducted in patients with hip and/or knee OA to assess therapeutic efficacy in patients requiring treatment switch due to lack of effectiveness and/or tolerability in primary care settings. Therapeutic effectiveness was assessed by patient satisfaction using the osteoARthritis Treatment Satisfaction (ARTS) scale. The 3-month disease change [by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a pain visual analog scale (VAS)] and its correlation with treatment satisfaction were also assessed, as well as patient gastrointestinal (GI) and cardiovascular (CV) profiles. 5,976 patients were analyzed (mean age 68.8 years, 65.1 % female). 67 and 61.8 % showed high GI and CV risk, respectively. The proportion of patients on acetaminophen treatment during the study decreased from 74.8 % at baseline to 23.9 %, while the proportion on non-steroidal anti-inflammatory drugs (NSAIDs) increased from 59.8 to 85.8 %. At 3 months, the standardized (0-100) overall ARTS score increased from 57.7 to 71.6 (p < 0.0001), while disease severity decreased. There was a significant (p < 0.0001) negative association between the ARTS, and the WOMAC and VAS scores. Treatment switching from acetaminophen to NSAIDs as a consequence of poor effectiveness and/or tolerability resulted in increased patient satisfaction with treatment and lower OA severity.


Assuntos
Acetaminofen/uso terapêutico , Analgésicos não Narcóticos/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Osteoartrite do Quadril/tratamento farmacológico , Osteoartrite do Joelho/tratamento farmacológico , Satisfação do Paciente , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Estudos Prospectivos , Falha de Tratamento , Resultado do Tratamento
13.
Trials ; 14: 348, 2013 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-24152576

RESUMO

BACKGROUND: Pressure 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: Clinicaltrials.gov identifier: NCT01595347.


Assuntos
Ácidos Graxos/uso terapêutico , Imobilização/efeitos adversos , Óleos de Plantas/uso terapêutico , Úlcera por Pressão/prevenção & controle , Atenção Primária à Saúde , Projetos de Pesquisa , Protocolos Clínicos , Análise Custo-Benefício , Custos de Medicamentos , Ácidos Graxos/economia , Humanos , Modelos Logísticos , Análise Multivariada , Azeite de Oliva , Óleos de Plantas/economia , Úlcera por Pressão/diagnóstico , Úlcera por Pressão/economia , Úlcera por Pressão/etiologia , Espanha , Fatores de Tempo , Resultado do Tratamento
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