SAS - D.S.A.P. Valle del Guadalhorce

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A Methodological Approach for Implementing an Integrated Multimorbidity Care Model: Results from the Pre-Implementation Stage of Joint Action CHRODIS-PLUS.
(MDPI, 2019-11-06) Palmer, Katie; Carfì, Angelo; Angioletti, Carmen; Di Paola, Antonella; Navickas, Rokas; Dambrauskas, Laimis; Jureviciene, Elena; João Forjaz, Maria; Rodriguez-Blazquez, Carmen; Prados-Torres, Alexandra; Gimeno-Miguel, Antonio; Cano-Del Pozo, Mabel; Bestue-Cardiel, Maria; Leiva-Fernandez, Francisca; Poses Ferrer, Elisa; Carriazo, Ana M; Lama, Carmen; Rodriguez-Acuña, Rafael; Cosano, Inmaculada; Bedoya-Belmonte, Juan Jose; Liseckiene, Ida; Barbolini, Mirca; Txarramendieta, Jon; de Manuel Keenoy, Esteban; Fullaondo, Ane; Rijken, Mieke; Onder, Graziano; European Union
Patients with multimorbidity (defined as the co-occurrence of multiple chronic diseases) frequently experience fragmented care, which increases the risk of negative outcomes. A recently proposed Integrated Multimorbidity Care Model aims to overcome many issues related to fragmented care. In the context of Joint Action CHRODIS-PLUS, an implementation methodology was developed for the care model, which is being piloted in five sites. We aim to (1) explain the methodology used to implement the care model and (2) describe how the pilot sites have adapted and applied the proposed methodology. The model is being implemented in Spain (Andalusia and Aragon), Lithuania (Vilnius and Kaunas), and Italy (Rome). Local implementation working groups at each site adapted the model to local needs, goals, and resources using the same methodological steps: (1) Scope analysis; (2) situation analysis-"strengths, weaknesses, opportunities, threats" (SWOT) analysis; (3) development and improvement of implementation methodology; and (4) final development of an action plan. This common implementation strategy shows how care models can be adapted according to local and regional specificities. Analysis of the common key outcome indicators at the post-implementation phase will help to demonstrate the clinical effectiveness, as well as highlight any difficulties in adapting a common Integrated Multimorbidity Care Model in different countries and clinical settings.
A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial.
(2018-02-23) Fernández, Anna; Mendive, Juan M; Conejo-Cerón, Sonia; Moreno-Peral, Patricia; King, Michael; Nazareth, Irwin; Martín-Pérez, Carlos; Fernández-Alonso, Carmen; Rodríguez-Bayón, Antonina; Aiarzaguena, Jose Maria; Montón-Franco, Carmen; Serrano-Blanco, Antoni; Ibañez-Casas, Inmaculada; Rodríguez-Sánchez, Emiliano; Salvador-Carulla, Luis; Garay, Paola Bully; Ballesta-Rodríguez, María Isabel; LaFuente, Pilar; Del Mar Muñoz-García, María; Mínguez-Gonzalo, Pilar; Araujo, Luz; Palao, Diego; Gómez, María Cruz; Zubiaga, Fernando; Navas-Campaña, Desirée; Aranda-Regules, Jose Manuel; Rodriguez-Morejón, Alberto; de Dios Luna, Juan; Bellón, Juan Ángel
Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care. Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months. With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results. Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated. ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.
[ANALES DE PEDIATRÍA: We take over].
(2021-09-02) Antón Gamero, Montserrat; Ávila Álvarez, Alejandro; Balaguer-Martínez, Josep Vicent; Bueno Campaña, Mercedes; Navas López, Víctor Manuel
Beyond the consultation room: Proposals to approach health promotion in primary care according to health-care users, key community informants and primary care centre workers.
(2017-01-24) Berenguera, Anna; Pons-Vigués, Mariona; Moreno-Peral, Patricia; March, Sebastià; Ripoll, Joana; Rubio-Valera, Maria; Pombo-Ramos, Haizea; Asensio-Martínez, Angela; Bolaños-Gallardo, Eva; Martínez-Carazo, Catalina; Maderuelo-Fernández, José Ángel; Martínez-Andrés, Maria; Pujol-Ribera, Enriqueta
Primary health care (PHC) is the ideal setting to provide integrated services centred on the person and to implement health promotion (HP) activities. To identify proposals to approach HP in the context of primary care according to health-care users aged 45-75 years, key community informants and primary care centre (PCC) workers. Descriptive-interpretive qualitative research with 276 participants from 14 PCC of seven Spanish regions. A theoretical sampling was used for selection. A total of 25 discussion groups, two triangular groups and 30 semi-structured interviews were carried out. A thematic interpretive contents analysis was carried out. Participants consider that HP is not solely a matter for the health sector and they emphasize intersectoral collaboration. They believe that it is important to strengthen community initiatives and to create a healthy social environment that encourages greater responsibility and participation of health-care users in decisions regarding their own health and better management of public services and resources. HP, care in the community and demedicalization should be priorities for PHC. Participants propose organizational changes in the PCC to improve HP. PCC workers are aware that HP falls within the scope of their responsibilities and propose to increase their training, motivation, competences and knowledge of the social environment. Informants emphasize that HP should be person-centred approach and empathic communication. HP activities should be appealing, ludic and of proven effectiveness. According to a socio-ecological and intersectoral model, PHC services must get actively involved in HP together with community and through outreach interventions.
Body mass index interacts with a genetic-risk score for depression increasing the risk of the disease in high-susceptibility individuals.
(Nature Publishing Group, 2022-01-04) Anguita-Ruiz, Augusto; Zarza-Rebollo, Juan Antonio; Perez-Gutierrez, Ana M; Molina, Esther; Gutierrez, Blanca; Bellon, Juan Angel; Moreno-Peral, Patricia; Conejo-Ceron, Sonia; Aiarzagüena, Jose Maria; Ballesta-Rodriguez, M Isabel; Fernandez, Anna; Fernandez-Alonso, Carmen; Martin-Perez, Carlos; Monton-Franco, Carmen; Rodriguez-Bayon, Antonina; Torres-Martos, Alvaro; Lopez-Isac, Elena; Cervilla, Jorge; Rivera, Margarita; Spanish Ministry of Health, the Institute of Health Carlos III (ISCIII), and the European Regional Development Fund; Andalusian Council of Health; Spanish Network of Primary Care Research, redIAPP; Mental Health, Services and Primary Care Málaga group
Depression is strongly associated with obesity among other chronic physical diseases. The latest mega- and meta-analysis of genome-wide association studies have identified multiple risk loci robustly associated with depression. In this study, we aimed to investigate whether a genetic-risk score (GRS) combining multiple depression risk single nucleotide polymorphisms (SNPs) might have utility in the prediction of this disorder in individuals with obesity. A total of 30 depression-associated SNPs were included in a GRS to predict the risk of depression in a large case-control sample from the Spanish PredictD-CCRT study, a national multicentre, randomized controlled trial, which included 104 cases of depression and 1546 controls. An unweighted GRS was calculated as a summation of the number of risk alleles for depression and incorporated into several logistic regression models with depression status as the main outcome. Constructed models were trained and evaluated in the whole recruited sample. Non-genetic-risk factors were combined with the GRS in several ways across the five predictive models in order to improve predictive ability. An enrichment functional analysis was finally conducted with the aim of providing a general understanding of the biological pathways mapped by analyzed SNPs. We found that an unweighted GRS based on 30 risk loci was significantly associated with a higher risk of depression. Although the GRS itself explained a small amount of variance of depression, we found a significant improvement in the prediction of depression after including some non-genetic-risk factors into the models. The highest predictive ability for depression was achieved when the model included an interaction term between the GRS and the body mass index (BMI), apart from the inclusion of classical demographic information as marginal terms (AUC = 0.71, 95% CI = [0.65, 0.76]). Functional analyses on the 30 SNPs composing the GRS revealed an over-representation of the mapped genes in signaling pathways involved in processes such as extracellular remodeling, proinflammatory regulatory mechanisms, and circadian rhythm alterations. Although the GRS on its own explained a small amount of variance of depression, a significant novel feature of this study is that including non-genetic-risk factors such as BMI together with a GRS came close to the conventional threshold for clinical utility used in ROC analysis and improves the prediction of depression. In this study, the highest predictive ability was achieved by the model combining the GRS and the BMI under an interaction term. Particularly, BMI was identified as a trigger-like risk factor for depression acting in a concerted way with the GRS component. This is an interesting finding since it suggests the existence of a risk overlap between both diseases, and the need for individual depression genetics-risk evaluation in subjects with obesity. This research has therefore potential clinical implications and set the basis for future research directions in exploring the link between depression and obesity-associated disorders. While it is likely that future genome-wide studies with large samples will detect novel genetic variants associated with depression, it seems clear that a combination of genetics and non-genetic information (such is the case of obesity status and other depression comorbidities) will still be needed for the optimization prediction of depression in high-susceptibility individuals.
Characteristics, consequences and prevention of falls in institutionalised older adults in the province of Malaga (Spain): a prospective, cohort, multicentre study.
(2018-02-23) Aranda-Gallardo, Marta; Morales-Asencio, Jose M; Enriquez de Luna-Rodriguez, Margarita; Vazquez-Blanco, Maria J; Morilla-Herrera, Juan C; Rivas-Ruiz, Francisco; Toribio-Montero, Juan C; Canca-Sanchez, Jose C
Falls are an important adverse event among institutionalised persons. It is in this clinical setting where falls occur more frequently than in any other, despite the measures commonly taken to prevent them. This study aimed to determine the characteristics of a typical institutionalised elderly patient who suffers a fall and to describe the physical harms resulting from this event. We then examined the association between falls and the preventive measures used. This was a prospective cohort study in 37 nursing homes in Spain. The participants were all the nursing home residents institutionalised in these centres from May 2014 to July 2016. Participants were followed up for 9 months. During this period, two observations were made to evaluate the preventive measures taken and to record the occurrence of falls. 896 residents were recruited, of whom 647 completed the study. During this period, 411 falls took place, affecting 213 residents. The injuries caused by the falls were mostly minor or moderate. They took place more frequently among women and provoked 22 fractures (5.35%). The most commonly used fall prevention measure was bed rails (53.53% of cases), followed by physical restraint (16.79%). The latter measure was associated with a higher incidence of injuries not requiring stitches (OR=2.06, 95% CI 1.01 to 4.22, P=0.054) and of injuries that did require stitches (OR=3.51, 95% CI 1.36 to 9.01, P=0.014) as a consequence of falls. Bed rails protected against night-time falls. Falls are a very common adverse event in nursing homes. The prevention of falls is most commonly addressed by methods to restrain movement. The use of physical restraints is associated with a greater occurrence of injuries caused by a fall.
Comparing watchful waiting with antidepressants for the management of subclinical depression symptoms to mild-moderate depression in primary care: a systematic review.
(2017) Iglesias-González, Maria; Aznar-Lou, Ignacio; Gil-Girbau, Montse; Moreno-Peral, Patricia; Peñarrubia-María, M Teresa; Rubio-Valera, Maria; Serrano-Blanco, Antoni
The benefits of watchful waiting (WW) over antidepressants (ADs) for the treatment of depression in primary care (PC) are unclear. We aimed to systematically review the evidence supporting either WW or ADs for the treatment of subclinical depressive symptoms and mild-moderate depression in a PC setting. This systematic review was registered at PROSPERO (42016036345). Four electronic sources (EMBASE, PubMed, PsycINFO, Web of Knowledge) were systematically searched from inception to November 2016 for controlled trials comparing WW and ADs in PC following established guidelines. The studies had to include adult population with new symptoms of subclinical depression or mild-moderate depression. Patients in the intervention group should receive a WW approach, while patients in the control group underwent treatment with ADs. The abstraction form included information on the setting, characteristics of the study population, total sample size, size of the control and intervention groups and date of the study. Outcome measures and variability were extracted. The scarcity of studies and the considerable clinical and methodological heterogeneity discouraged us from performing a meta-analysis. Three articles were included and qualitatively synthesized. There was no evidence for the superiority of one treatment option over the other, although two of the studies suggested small differences in favour of ADs when less conservative analyses were conducted (per protocol analysis and analysis not adjusted for missingness predictors). Superiority was not demonstrated by either treatment option. More robust evidence is needed to inform recommendations for the management of depressive symptoms in PC.
Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.
(2018-07-13) Zabaleta-Del-Olmo, Edurne; Pombo, Haizea; Pons-Vigués, Mariona; Casajuana-Closas, Marc; Pujol-Ribera, Enriqueta; López-Jiménez, Tomás; Cabezas-Peña, Carmen; Martín-Borràs, Carme; Serrano-Blanco, Antoni; Rubio-Valera, Maria; Llobera, Joan; Leiva, Alfonso; Vicens, Caterina; Vidal, Clara; Campiñez, Manuel; Martín-Álvarez, Remedios; Maderuelo, José-Ángel; Recio, José-Ignacio; García-Ortiz, Luis; Motrico, Emma; Bellón, Juan-Ángel; Moreno-Peral, Patricia; Martín-Cantera, Carlos; Clavería, Ana; Aldecoa-Landesa, Susana; Magallón-Botaya, Rosa; Bolíbar, Bonaventura
Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.
[Comprehensive approach to children with cerebral palsy].
(2021-08-27) Peláez Cantero, María José; Moreno Medinilla, Esther Eugenia; Cordón Martínez, Ana; Gallego Gutiérrez, Silvia
Infantile cerebral palsy is one of the most prevalent diseases and the most frequent cause of disability in paediatrics. Children with cerebral palsy have complex health care needs and often require the care of a multidisciplinary team. However, in many cases there is no paediatrician with overall responsibility for coordinating follow-up. We have produced a support document intended for paediatricians coordinating the care of children with cerebral palsy. Our aim is to provide an ordered compilation of the main issues these patients may develop, to know how to identify and address them if necessary, and to establish criteria for referring these patients to other specialists.
Correction to: Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.
(2018-08-13) Zabaleta-Del-Olmo, Edurne; Pombo, Haizea; Pons-Vigués, Mariona; Casajuana-Closas, Marc; Pujol-Ribera, Enriqueta; López-Jiménez, Tomás; Cabezas-Peña, Carmen; Martín-Borràs, Carme; Serrano-Blanco, Antoni; Rubio-Valera, Maria; Llobera, Joan; Leiva, Alfonso; Vicens, Caterina; Vidal, Clara; Campiñez, Manuel; Martín-Álvarez, Remedios; Maderuelo, José-Ángel; Recio, José-Ignacio; García-Ortiz, Luis; Motrico, Emma; Bellón, Juan-Ángel; Moreno-Peral, Patricia; Martín-Cantera, Carlos; Clavería, Ana; Aldecoa-Landesa, Susana; Magallón-Botaya, Rosa; Bolíbar, Bonaventura
It has been highlighted the original article (1) contained a typesetting mistake in the authorship, and that author Caterine Vicens was omitted.
Cross-cultural adaptation and psychometric validation of a Spanish version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.
(BMJ, 2022-03-22) de Juan-Roldan, Jose Ignacio; Castillo-Jimena, Marcos; Gonzalez-Hevilla, Alba; Sanchez-Sanchez, Clara; Garcia-Ruiz, Antonio J; Gavilan-Moral, Enrique; Spanish Society of Family and Community Medicine (SEMFYC); Andalusian Society of Family and Community Medicine (SAMFYC)
Successful deprescribing depends largely on factors related to the patient. The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was developed with the objective of evaluating the beliefs and attitudes of older adults and caregivers towards deprescribing. The present study was designed to validate a Spanish version of the rPATD questionnaire, both the versions for older adults and for caregivers, through a qualitative validation phase and the analysis of its psychometric properties. Cross-sectional validation study. Primary care settings in Málaga (Spain). A sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study. In the qualitative validation stage, the rPATD questionnaire was translated/back-translated and subjected to a cross-cultural adaptation to evaluate its face validity and feasibility. Next, its psychometric properties were assessed. Confirmatory factor analysis was used to evaluate construct validity. Internal consistency was determined using Cronbach's alpha test. Criterion validity through pre-established hypotheses from the Beliefs about Medicines Questionnaire (BMQ) Specific-Concerns Scale, and test-retest reliability were analysed. Confirmatory factor analysis verified the four-factor structure of the original rPATD questionnaire, with items loading into four factors: involvement, burden, appropriateness and concerns about stopping. The Cronbach's alpha coefficient of the factors ranged from 0.683 to 0.879. The burden, appropriateness and concerns about stopping factors were significantly correlated with the BMQ Specific-Concerns Score, except for the concerns about stopping factor in the older adults' version. The consistency of the items between administration times (test-retest reliability) showed weighted Cohen's kappa values ranging from moderate (>0.4) to very good (>0.8). The Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.
Development of the therapeutic language coding system (SICOLENTE): Reliability and construct validity.
(2018-12-26) Rodríguez-Morejón, Alberto; Zamanillo, Alberto; Iglesias, Gabriel; Moreno-Gámez, Alberto; Navas-Campaña, Desirée; Moreno-Peral, Patricia; Rodríguez-Arias, José Luis
Since the use of language is a core aspect of psychotherapy, its study requires instruments that allow for further research. The aim of this study is to present an observational instrument capable of analyzing the language used in psychotherapeutic settings, both by therapists and clients. The SICOLENTE instrument was applied to two different samples: The Three Approaches to Psychotherapy film and a naturalistic sample. 7710 utterances from 31 sessions (three from the demonstration film and 28 from a naturalistic setting) were coded. Two studies were conducted: in the first study, inter and intra coder reliability (dimension and category levels) and Generalizability theory analyzes were assessed, whilst in the second study, construct validity was tested with several hypotheses. The final instrument resulted in 20 categories with three dimensions: Conversational Act (7 categories), Therapeutic topic (6 categories) and Content (7 categories). The three dimensions showed excellent inter and intra coder reliability and the generalizability coefficients were excellent. Out of the 24 validity hypothesis proposed,19 were accepted. The finding suggests that the SICOLENTE is a reliable and valid instrument that can be applied to investigate the performance of various theoretical models. Its three dimensional structure gives it the flexibility to be able to carry out macroscopic or microscopic language research.
Effect of copayment policies on initial medication non-adherence according to income: a population-based study.
(2018-03-15) Aznar-Lou, Ignacio; Pottegård, Anton; Fernández, Ana; Peñarrubia-María, María Teresa; Serrano-Blanco, Antoni; Sabés-Figuera, Ramón; Gil-Girbau, Montserrat; Fajó-Pascual, Marta; Moreno-Peral, Patricia; Rubio-Valera, Maria
Copayment policies aim to reduce the burden of medication expenditure but may affect adherence and generate inequities in access to healthcare. The objective was to evaluate the impact of two copayment measures on initial medication non-adherence (IMNA) in several medication groups and by income level. A population-based study was conducted using real-world evidence. Primary care in Catalonia (Spain) where two separate copayment measures (fixed copayment and coinsurance) were introduced between 2011 and 2013. Every patient with a new prescription issued between 2011 and 2014 (3 million patients and 10 million prescriptions). IMNA was estimated throughout dispensing and invoicing information. Changes in IMNA prevalence after the introduction of copayment policies (immediate level change and trend changes) were estimated through segmented logistic regression. The regression models were stratified by economic status and medication groups. Before changes to copayment policies, IMNA prevalence remained stable. The introduction of a fixed copayment was followed by a statistically significant increase in IMNA in poor population, low/middle-income pensioners and low-income non-pensioners (OR from 1.047 to 1.370). In high-income populations, there was a large statistically non-significant increase. IMNA decreased in the low-income population after suspension of the fixed copayment and the introduction of a coinsurance policy that granted this population free access to medications (OR=0.676). Penicillins were least affected while analgesics were affected to the greatest extent. IMNA to medications for chronic conditions increased in low/middle-income pensioners. Even nominal charge fixed copayment may generate inequities in access to health services. An anticipation effect and expenses associated with IMNA may have generated short-term costs. A reduction in copayment can protect from non-adherence and have positive, long-term effects. Copayment scenarios could have considerable long-term consequences for health and costs due to increased IMNA in medication for chronic physical conditions.
Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).
(2020-05-12) Morilla-Herrera, Juan C; Morales-Asencio, José M; Gómez-González, Alberto J; Díez-De Los Ríos, Antonio; Lupiáñez-Pérez, Inmaculada; Acosta-Andrade, Carlos; Aranda-Gallardo, Marta; Moya-Suárez, Ana B; Kaknani-Uttumchandani, Shakira; García-Mayor, Silvia
To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact® ) against a silver dressing (Aquacel® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing. Open randomized controlled trial, with blinded endpoint. Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks. Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.
Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).
(2020-06-08) Morilla-Herrera, Juan C; Morales-Asencio, José M; Gómez-González, Alberto J; Díez-De Los Ríos, Antonio; Lupiáñez-Pérez, Inmaculada; Acosta-Andrade, Carlos; Aranda-Gallardo, Marta; Moya-Suárez, Ana B; Kaknani-Uttumchandani, Shakira; García-Mayor, Silvia
To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact® ) against a silver dressing (Aquacel® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing. Open randomized controlled trial, with blinded endpoint. Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks. Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.
Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).
(2017-04-27) Prados-Torres, Alexandra; Del Cura-González, Isabel; Prados-Torres, Daniel; López-Rodríguez, Juan A; Leiva-Fernández, Francisca; Calderón-Larrañaga, Amaia; López-Verde, Fernando; Gimeno-Feliu, Luis A; Escortell-Mayor, Esperanza; Pico-Soler, Victoria; Sanz-Cuesta, Teresa; Bujalance-Zafra, Mª Josefa; Morey-Montalvo, Mariel; Boxó-Cifuentes, José Ramón; Poblador-Plou, Beatriz; Fernández-Arquero, José Manuel; González-Rubio, Francisca; Ramiro-González, María D; Coscollar-Santaliestra, Carlos; Martín-Fernández, Jesús; Barnestein-Fonseca, Mª Pilar; Valderas-Martínez, José María; Marengoni, Alessandra; Muth, Christiane; Multi-PAP Group
Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care. Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months). n = 400 (200 per study arm). complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. Clinicaltrials.gov, NCT02866799.
Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.
(BioMed Central, 2013-10) Lupiáñez-Pérez, Inmaculada; Morilla-Herrera, Juan Carlos; Ginel-Mendoza, Leovigildo; Martín-Santos, Francisco Javier; Navarro-Moya, Francisco Javier; Sepúlveda-Guerra, Rafaela Pilar; Vázquez-Cerdeiros, Rosa; Cuevas-Fernández-Gallego, Magdalena; Benítez-Serrano, Isabel María; Lupiáñez-Pérez, Yolanda; Morales-Asencio, José Miguel; [Lupiañez-Pérez,I; Morilla-Herrera,JC; Ginel-Mendoza,L; Martín-Santos,FJ; Navarro-Moya,FJ; Sepúlveda-Guerra,RP; Vázquez-Cerdeiros,R; Cuevas-Fernández-Gallego,M] District of Primary Health Care Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. [Benítez-Serrano,IM] District of Primary Health Care Costa of Sol, Andalusian Health Service, Malaga, Spain. [Lupiañez-Pérez,Y] University Hospital Virgen de la Victoria, Málaga, Spain. [Lupiañez-Pérez,Y] Regional Hospital Carlos Haya, Malaga, Spain. [Morales-Asencio,JM] Faculty of Health Sciences, University of Málaga, Spain.; This research has been funded by the Independent Clinical Calls and Proposals managed by the Spanish Ministry of Health, Social Policy and Equality (EC11-526).
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.
Effectiveness of online interventions in preventing depression: a protocol for systematic review and meta-analysis of randomised controlled trials.
(2018-11-28) Rigabert, Alina; Motrico, Emma; Moreno-Peral, Patricia; Resurrección, Davinia M; Conejo-Cerón, Sonia; Navas-Campaña, Desirée; Bellón, Juan Á
Although evidence exists for the efficacy of psychosocial interventions in preventing depression, little is known about its prevention through online interventions. The objective of this study is to conduct a systematic review and meta-analysis of randomised controlled trials assessing the effectiveness of online interventions in preventing depression in heterogeneous populations. We will conduct a systematic review and meta-analysis of randomised controlled trials that will be identified through searches of PubMed, PsycINFO, WOS, Scopus, OpenGrey, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Australia New Zealand Clinical Trials Register . We will also search the reference lists provided in relevant studies and reviews. Experts in the field will be contacted to obtain more references. Two independent reviewers will assess the eligibility criteria of all articles, extract data and determine their risk of bias (Cochrane Collaboration Tool). Baseline depression will be required to have been discarded through standardised interviews or validated self-reports with standard cut-off points. The outcomes will be the incidence of new cases of depression and/or the reduction of depressive symptoms as measured by validated instruments. Pooled standardised mean differences will be calculated using random-effect models. Heterogeneity and publication bias will be estimated. Predefined sensitivity and subgroup analyses will be performed. If heterogeneity is relevant, random-effect meta-regression will be performed. The results will be disseminated through peer-reviewed publication and will be presented at a professional conference. Ethical assessment is not required as we will search and assess existing sources of literature. CRD42014014804; Results.
Effectiveness of online psychological and psychoeducational interventions to prevent depression: Systematic review and meta-analysis of randomized controlled trials.
(2020-10-24) Rigabert, Alina; Motrico, Emma; Moreno-Peral, Patricia; Resurrección, Davinia María; Conejo-Cerón, Sonia; Cuijpers, Pim; Martín-Gómez, Carmen; López-Del-Hoyo, Yolanda; Bellón, Juan Ángel
Although evidence exists for the efficacy of interventions to prevent depression, little is known about its prevention through online interventions. We aim to assess the effectiveness of online psychological and psychoeducational interventions to prevent depression in heterogeneous populations. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted based on literature searches in eight electronic data bases and other sources from inception to 22 July 2019. Of the 4181 abstracts reviewed, 501 were selected for full-text review, and 21 RCTs met the inclusion criteria, representing 10,134 participants from 11 countries and four continents. The pooled SMD was -0·26 (95%CI: -0·36 to -0·16; p
Effectiveness of psychological and educational interventions for the prevention of depression in the workplace: A systematic review and meta-analysis.
(Nordic Association of Occupational Safety and Health (NOROSH), 2018-11-30) Bellon, Juan Angel; Conejo-Ceron, Sonia; Cortes-Abela, Cayetana; Pena-Andreu, Jose Miguel; Garcia-Rodriguez, Antonio; Moreno-Peral, Patricia; Spanish Ministry of Health; Institute of Health Carlos III; European Regional Development Fund; Andalusian Council of Health; Prevention and Health Promotion Research Network ‘redIAPP’
Objectives Psychological and educational interventions for the prevention of depression have a small-to-moderate effect. However, little is known about their effectiveness in the workplace. We aimed to evaluate the effectiveness of such interventions through a systematic review and meta-analysis of randomized controlled trials (RCT). Methods We searched PubMed, PsycINFO, EMBASE, CENTRAL, CIS-DOC and Open Grey for RCT. Search was supplemented with manual searches of reference lists of relevant meta-analyses and trials. We included RCT that assessed either the incidence of depression or the reduction of depressive symptoms, which excluded participants with baseline depression. Measurements were required to have been made using validated instruments and participants recruited in the workplace. Independent evaluators selected studies, evaluated risk bias (Cochrane Collaboration's tool) and extracted from RCT. The combined OR was estimated using the fixed-effects model. Heterogeneity was measured by I 2and Cochrane's Q. Results Of the 1963 abstracts reviewed, 69 were selected for review in fulltext. Only three RCT met our inclusion criteria, representing 1246 workers from three different countries and continents. The combined odds ratio was 0.25 [95% confidence interval (CI) 0.11-0.60, P=0.002]; I 2=0% and Q=0.389 (P=0.823). The risk of bias was low in one RCT and moderate and high in the other two, respectively. Conclusion Psychological or educational interventions in the workplace may prevent depression, although the quality of evidence was low.

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