Healthcare service use for children with chronic complex diseases: A longitudinal six-year follow-up study.

PURPOSE: The objective was analysed the patterns use of healthcare services of this population and the influence of their clinical and sociodemographic characteristics. DESIGN AND METHODS: A six-year longitudinal follow-up study was performed to evaluate the annual healthcare resources use and clinical data among children with complex chronic diseases in Spain between 2015 and 2021. The sample trends in healthcare usage and the associated factors were analysed using ANCOVA and multivariable linear regression models. RESULTS: Patients had high attendance during the follow-up period, with >15 episodes year. This trend decreased over time, especially in children with oncological diseases compared with other diseases (F (16.75; 825.4) = 32.457; p < 0.001). A multivariable model showed that children with a greater number of comorbidities (ß = 0.17), shorter survival time (ß = -0.23), who had contact with the palliative care unit (ß = 0.16), and whose mothers had a higher professional occupation (ß = 0.14), had a greater use of the healthcare system. CONCLUSIONS: Children with a higher number of comorbidities and the use of medical devices made a greater frequentation of health services, showing a trend of decreasing use over time. Socioeconomic factors such as mothers' occupational status determine healthcare frequentation. These results suggest the existence of persistent gaps in care coordination sustained over time. PRACTICAL IMPLICATIONS: Systematized and coordinated models of care for this population should consider the presence of inequalities in health care use.

Quality of Life, Physical and Mental Health, and Economic Evaluation of Family Caregivers of Chronic Dependent Children: INFAPRINT Cohort Study Protocol.

BACKGROUND: Caregivers for children with complex chronic illnesses may experience emotional and physical strain, especially as concerns attention overload and the perceptions of their own psychosocial situation. These concerns, together with the additional financial cost and the socioeconomic inequalities that arise from caregiving responsibilities, create major challenges to the health status of this population group. METHODS: A prospective analytical longitudinal study will be conducted, based on an exposed cohort of adult caregivers (parents or guardians) for children with complex chronic processes, to evaluate the impact of caregiving responsibilities on the health status of this population group. CONCLUSIONS AND IMPLICATIONS: The practical implications of this study are of great significance for clinical practice. The results of this study have the potential to inform the decision-making process in the healthcare sector and guide future research initiatives. The findings of this study will provide crucial insights into the health-related quality of life of caregivers of children with complex chronic illnesses, which will be valuable in addressing the challenges faced by this population group. This information can be used to improve the availability and accessibility of appropriate health services and to facilitate the development of more equitable health outcomes for caregivers of children with complex chronic illnesses. By highlighting the extent to which this population is affected both physically and mentally, the study can contribute to the development of clinical practices that prioritize the health and well-being of caregivers in the care of children with complex chronic illnesses.

A protocol for a randomized trial measuring flowmetry in risk areas for pressure ulcer: Hyperoxygenated fatty acids vs olive oil.

BACKGROUND: Pressure ulcers are a common adverse event in healthcare. To date, no flowmetry studies have been conducted to compare hyperoxygenated fatty acids (HFA) vs. extra-virgin olive oil (EVOO) in alleviating this condition. AIMS: To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients. DESIGN: Two-phase experimental study. METHODS: Phase 1 will be conducted with healthy subjects, using a randomised, open study design, evaluating an intrasubject control group. Phase 2 will focus on hospitalised subjects, with a randomised, open study group vs. a control group. DISCUSSION: This Project is undertaken to identify the mechanisms that intervene in the genesis of pressure ulcers and to determine whether there are differences in outcomes between the application of HFA vs. EVOO as a preventive measure The results of this study are of economic importance (due to the price difference between the products used) and will also impact on usual clinical practice for patients with impaired mobility and liable to suffer from pressure ulcers, by considering an alternative to established preventive measures.

Utilization of Parallel Resources and Sociodemographic Factors in Treating Children with Complex Chronic Diseases: A Cross-Sectional Study.

BACKGROUND: Children with complex chronic conditions have a high need for health and social care resources. Many parents explore parallel resources such as alternative therapies, associations, psychological support, private medical consultations, and other out-of-pocket expenses for healthcare. The use of these alternative health resources is sometimes unclear and may lead to health inequalities. To characterize the use made of alternative healthcare resources for children with complex chronic conditions. Additionally, we evaluate the influence of sociodemographic factors on the distribution of this utilization of resources; (2) Methods: Cross-sectional study. Children with complex chronic diseases were treated at a tertiary hospital in Granada, Spain in 2016. We analyzed their use of healthcare resources and socioeconomic variables. This research complies with STROBE guidelines for observational studies; (3) Results: In total, 265 children were analyzed (mean age 7.3 years, SD 4.63). A total of 105 children (39.6%) attended private consultations with specialists, and 12.1% (n = 32) of the children had additional private health insurance. One out three parents belonged to a mutual support association (n = 78), and 26% (n = 69) of the children used alternative therapies. Furthermore, 75.4% (n = 199) of the children received no psychological support. Children whose parents had a higher educational level and occupations status made greater use of parallel healthcare resources.; (4) Conclusions: A significant proportion of children used multiple health resources in addition to the public healthcare system depending on sociodemographic determinants. Studies are needed to determine whether the use of these alternative services achieves better levels of health.

Predictors of health service use by family caregivers of persons with multimorbidity.

BACKGROUND: Informal caregivers of patients with multiple chronic conditions are socially good, promoting the sustainability of a large part of home care provision. However, this very demanding activity causes health problems that increase their own need for health services. This study analyses the use of health services by informal carers, comparing it with the use made by the general population with similar characteristics. METHODOLOGY: Cross-sectional analytical study carried out in the Malaga-Valle Guadalhorce Primary Health Care District (Spain). Healthcare demand and perceived health were measured in the family caregivers, compared to the general population. Strobe Statement for observational studies has been used to strength the report of the results. RESULTS: Final sample consisted of 314 family caregivers together with a subsample of 2.290 non-caregivers taken from data of the National Health Survey. This subsample was paired by gender with our sample. Formal caregivers make fewer annual visits to the health services, with respect to the general population, regardless of the perceived level of health. The difference of the means between those who perceive their health as very poor was 0.11 (95% CI: 0.01 to 0.20) consultations with the family doctor, 0.21 (95% CI: 0.15 to 0.26) consultations with medical specialists and 1.70 (95% CI: 1.52 to 1.87) emergency room attention. Three independent factors were identified that predispose to the increased use of health services: background of greater education achievement (OR 8.13, 95% CI: 1.30 to 50.68), non-cohabitation with the care recipient (OR 3.57, 95% CI: 1.16 to 11.11) and a more positive physical quality of life component (OR 1.06; 95% CI: 1.03 to 1.09). DISCUSSION AND IMPLICATIONS: Intrinsic components of the caregiver reveal their independent relationship with the provision of informal care and the use of health services. A broader vision is needed for the factors that influence the health of these caregivers to develop multipurpose interventions and improve the consistency and effectiveness of the health services offered to the caregiver.

Efficacy of a joint didactic intervention using the Junta De Andalucía School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial.

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.

Tissue temperature, flux and oxygen of sacral and trochanteric area under pressure of healthy subjects: A quasi-experimental study.

AIM: To evaluate the changes that take place in the perfusion, oxygenation and local temperature of the skin of the sacrum and trochanter when subjected to direct pressure for 2 h. METHODS: Quasi-experimental study in the preclinical phase with healthy subjects acting as their own controls (intrasubject control). The outcome variables were measured with a laser Doppler system (local temperature and oxygenation) and by near-infrared spectroscopy (perfusion). The pressure exerted was measured with a capacitive pressure sensor. No more than one week elapsed between the sacrum and trochanter measurements. RESULTS: The study sample consisted of 18 persons. The comparative analysis of the fluctuations in the parameters measured on the skin of the trochanters and sacrum, according to the time elapsed, revealed a statistically significant increase in temperature and in the pressure exerted. On the other hand, the changes in capillary blood flow and in SaO2 were not statistically significant. CONCLUSION: Our study results show that changes found in terms of temperature and pressure should be taking into account when planning personalised repositioning to patients according to biomechanical and biological situations that vary between anatomical areas. In future research, the changes reported could be evaluated in patients with risk factors for the development of pressure ulcers, thus facilitating the introduction of more personalised planning in the care and prevention of these injuries.

Effectiveness of a Diabetes Education Program based on Tailored interventions and Theory of Planned Behaviour: Cluster randomized controlled trial protocol.

AIM: To measure the Effectiveness of a Diabetes Education Program for people with T2DM, based on Tailored interventions and the Theory of Planned Behaviour. DESIGN: Cluster randomized controlled clinical trial. METHODS: This multicentre study will be carried out at 30 primary healthcare centres, where 436 persons with Type 2 Diabetes Mellitus (T2DM), aged between 18-75 years, will be recruited. The experimental educational program to be applied is modelled using components obtained from a systematic review and prior qualitative analysis. In addition, a taxonomy of nursing practice is used to standardize the program, based on the Theory of Planned Behaviour as a conceptual model. The intervention will be carried out by community nurses, using ADAPP-Ti® , an application developed with FileMaker Pro v.18. The control group will receive usual care and data will be collected at 6, 12, and 18 months, for both groups. The primary outcome considered will be glycosylated haemoglobin and cardiovascular factors, while the secondary ones will be tobacco consumption, body mass index, barriers to self-care, health-related quality of life, and lifestyle modification. The protocol was approved by the Ethics Committee of the Province of Malaga (Spain) in November 2014. DISCUSSION: The degree of metabolic control in T2DM is not always associated with healthy lifestyles and significant levels of medication are often prescribed to achieve clinical objectives. An intervention focused on needs, based on the best available evidence and a solid conceptual framework, might successfully consolidate appropriate self-care behaviour in this population. IMPACT: The study will result in the publication of an educational program featuring well-defined interventions and activities that will enable clinicians to tailor health care to the individual's needs and to combat treatment inertia in attending this population.

Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).

AIM: 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. DESIGN: Open randomized controlled trial, with blinded endpoint. METHODS: 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. DISCUSSION: 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. IMPACT: 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.

Pressure levels in the trochanter area according to repositioning at different degrees of inclination in healthy subjects.

OBJECTIVES: Patient repositioning is a recommended intervention to prevent or treat pressure ulcers (PUs). One option under consideration is the tailored repositioning according to patient characteristics, but more knowledge is needed on how different repositioning patterns influence on skin pressure. To determine what degree of inclination of the body in bed generates more pressure in the trochanteric region. Additionally, to analyze the influence of factors such as gender, age and anthropometric characteristics in the variations of this pressure. METHODS: Analytical cross-sectional study. Body Mass Index (BMI), lean mass and fat mass were measured in healthy volunteers subject to different inclinations (90°, 60° and 30°) in right lateral decubitus. Pressure was measured with a capacitive surface. RESULTS: In total, 146 subjects were included, of which 45 were men and 101 women. The results showed pressure differences due to the inclination according to gender and anthropometric values, being statistically significant in men at 90° and 60°, and in women at 30°. (hombres 90° p = 0,026, 60° p = 0,049; mujeres 30° p = 0,036) según prueba Brown-Forsythe. CONCLUSIONS: There are differences in the pressures of the trochanteric zone depending on anthropometric factors and by gender, in different body positions. Obese people exerted a higher pressure in the trochanter area at 30° of body inclination than overweight, normal weight and underweight people, respectively. From the clinical point of view, these findings invite to consider a possible differentiation in the repositioning interventions of the patients, according to gender and BMI, as a preventive strategy for PUs.

Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study.

AIM: To evaluate the relationship between the pressure exerted on the heel of one foot resting directly on a mattress, versus that exerted on the other heel, protected by a pillow beneath the Achilles tendon area and the changes thus produced in perfusion, oxygenation and temperature in the skin of heels of healthy volunteers lying in a supine position. DESIGN: Experimental study in a pre-clinical phase, with healthy volunteer participants and intrapeople control. METHODS: The study was carried out from November 2017 - May 2018. A pressure measurement surface was placed between the participant and the constant low-pressure support surface. Doppler laser devices were used to measure local temperature and perfusion. The degree of oxygenation was determined using an infrared beam close to the pressure zone in each heel. Both feet rested immobile on the bed, in a natural position, for 2 hr. To ensure intrapeople control, in every case the left heel was raised slightly, compared with the right. RESULTS: Eighteen participants took part in this study. Analysis of the results obtained showed that capillary blood flow was significantly reduced in the heel subjected to pressure, compared with the other heel, while no significant effects on oxygen saturation or temperature were observed. The variables associated with greater oxygen saturation were capillary blood flow, local temperature and pressure exerted. Fat-free mass, fat mass and duration of exposure to pressure were all significantly associated with reduced oxygen saturation. CONCLUSIONS: In healthy participants, when the heel is subjected to constant pressure against a constant low-pressure support surface, there is a significant reduction in blood flow, compared with the heel where pressure is relieved. However, there are no significant differences in temperature or tissue oxygenation. IMPACT: Significant reductions in vascular flow were observed; however, the oxygenation and temperature of the heel tissues remained unchanged. These findings, corroborated in real patients, would advance our understanding and facilitate decision-making on measures to prevent pressure ulcers, such as repositioning or tissue protection. TRIAL REGISTRATION: The protocol is registered in ClinicalTrials.gov (NCT02736838).

Development and Psychometric Validation of an Instrument to Identify Barriers to Self-Care Among Spanish Patients With Type 2 Diabetes on the Basis of Theory of Planned Behavior.

BACKGROUND: Several instruments are available to evaluate barriers to self-care in people with type 2 diabetes, but with significant psychometric weaknesses and poor theoretical background. OBJECTIVES: To develop and psychometrically validate a questionnaire to identify barriers to self-care in this population on the basis of the theory of planned behavior. METHODS: The study was carried out in 15 primary healthcare centers belonging to the Public Health Care System in Andalusia (Spain). After content validity was confirmed, an initial pilot study was undertaken (n = 54) and the model was evaluated in 2 samples of 205 subjects each to test its configural and metric invariance by confirmatory factor analysis. Internal consistency, test-retest reliability, criterion validity, and interpretability were carried out following COSMIN standards. RESULTS: A 4-factor instrument (intention, subjective norms, perceived control, and attitudes) with 15 items was obtained with a good fit: goodness-of-fit index = 0.92, comparative fit index = 0.93, and root mean square error of approximation = 0.043 (90% confidence interval 0.034-0.052). Cronbach α was 0.78, and test-retest reliability was adequate (intraclass correlation coefficient 0.73; P < .0001). The instrument revealed an adequate criterion validity depending on the treatment complexity and level of metabolic control. Thus, participants with poor self-care scores were more likely to suffer from diabetes-related complications (odds ratio 1.91; 95% confidence interval 1.15-3.1). CONCLUSIONS: A theory-driven instrument is suitable for its use with Spanish people with type 2 diabetes to assess their self-care needs and make tailored recommendations for lifestyle modifications on the basis of their behavioral determinants.

Socioeconomic Status and Health Services Utilization for Children With Complex Chronic Conditions Liable to Receive Nurse-Led Services: A Cross-Sectional Study.

AIM: To analyze the use of health services for children with severe chronic diseases, seeking to identify patterns of use according to sociodemographic and clinical conditions, and to identify unmet needs of care coordination that could benefit from nursing case management services. DESIGN: Cross-sectional study. METHODS: Children treated in ambulatory and hospital care in Granada, Spain, with complex chronic diseases in 2016 were analyzed to determine their use of healthcare resources. Socioeconomic variables were evaluated, along with clinical status and duration of their conditions. RESULTS: In total, 265 children were analyzed (mean age 7.3 years, SD 4.63; 56.6% male). The average duration of the disease was 63.26 months (SD 54.09). The most common types of disease were neurological (35.80%), congenital (23.90%), and oncological (18.90%). Multivariate analysis showed that children in need of advanced care (ß = 0.71), with a relatively recent diagnosis (ß = -0.11), with criteria for palliative care 1 (ß = -0.26), and whose mothers were older (ß = 0.36) and had a higher educational level (ß = 0.19) made greater use of healthcare resources during the preceding 12 months, whether urgent or scheduled (r2 = 78.0%, p < .001). CONCLUSIONS: Children with higher needs for advanced care have a heterogeneous use of healthcare resources depending on certain clinical and sociodemographic determinants. This finding highlights the importance of the identification of profiles of children and families for care coordination. The presence of sociodemographic determinants may need individualized approaches to assure a timely health care utilization. CLINICAL RELEVANCE: A significant proportion of the children used multiple health services, being treated at several centers simultaneously, and producing up to 139 total yearly contacts with the health system. Policymakers, healthcare providers, and patients' families should engage in a redesign of healthcare services for these children, providing comprehensive and coordinated systems of care for this population.

Peripheral perfusion and oxygenation in areas of risk of skin integrity impairment exposed to pressure patterns. A phase I trial (POTER Study).

AIM: The aim of this study was to analyse the change in peripheral oxygenation and microvascular flow in tissues subjected to different pressure regimes in healthy subjects and in hospitalized patients. BACKGROUND: The presence of pressure ulcers in hospitalized patients is a common complication that has a negative impact on health and often prolongs hospital stay and increases healthcare costs. DESIGN: Experimental non-controlled, non-randomized study in two phases: pre-clinical and clinical. METHODS: The pre-clinical phase will be conducted in healthy volunteers and the clinical phase, in patients at risk of impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas at risk of pressure ulcers will be evaluated by Doppler laser in subjects lying on a capacitive surface to measure pressure at 10,249 points. Different levels of pressure will be generated by changes in body position and changes in tissue perfusion and oxygenation will be monitored for up to 4 hours, to determine the implications for repositioning interventions in patients at risk. This study was funded in July 2015. The protocol is registered in ClinicalTrials.gov (NCT02736838). DISCUSSION: Pressure ulcer is a significant and complex health problem in long-term bedridden patients and there is currently no effective treatment or efficient prevention method. The information provided by our study will provide an accurate assessment of different thresholds for the onset of damage to the skin, associated with different body positions and pressure levels. TRIAL REGISTRATION: The protocol is registered in ClinicalTrials.gov (NCT02736838).

A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial.

Pressure ulcers represent a major current health problem and cause an important economic impact on the healthcare system. Most studies on the prevention of pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids (HOFA), and to date no studies have specifically examined the use of olive oil-based treatments. AIM: To evaluate the cost of using extra virgin olive oil, rather than HOFA, in the prevention of pressure ulcers among persons with impaired mobility and receiving home care. STUDY DESIGN: Cost minimization analysis of the results obtained from a noninferiority, triple-blind, parallel, multicenter, randomized clinical trial. Population attending primary healthcare centers in Andalusia (Spain). STUDY SAMPLE: 831 immobilized patients at risk of suffering pressure ulcers. These persons were included in the study and randomly assigned as follows: 437 to the olive oil group and 394 to the HOFA group. At the end of the follow-up period, the results obtained by the olive oil group were not inferior to those of the HOFA group, and did not exceed the 10% delta limit. The total treatment cost for 16 weeks was €19,758 with HOFAs and €9,566 with olive oil. Overall, the olive oil treatment was €10,192 less costly. It has been concluded the noninferiority of olive oil makes this product an effective alternative for the prevention of pressure ulcers in patients who are immobilized and in a domestic environment. This treatment enables considerable savings in direct costs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01595347. Date: 2011-2013.

[Spanish cultural adaptation and psychometric validation of the Summary of Diabetes Self-Care Activities measure (SDSCA) among persons with type 2 diabetes mellitus]. / Adaptación cultural al español y validación psicométrica del Summary of Diabetes Self-Care Activities measure (SDSCA) en personas con diabetes mellitus tipo 2.

OBJECTIVE: To undertake the cultural adaptation and the psychometric assessment of the Summary of Diabetes Self-Care Activities measure (SDSCA) in Spanish population with type 2 diabetes mellitus. DESIGN: Clinimetric validation study. SETTING: Primary health care centers of District Malaga and Valle del Guadalhorce. PARTICIPANTS: Three hundred thirty-one persons with type 2 diabetes mellitus. MAIN MEASUREMENTS: The SDSCA validated in mexican population was subjected to semantic and content equivalence using a Delphi method, its legibility was determined by INFLESZ scale. Subsequently psychometric validation was conducted through exploratory and confirmatory factor analysis (herein after EFA and CFA), internal consistency, test-retest reliability and discriminant validity. RESULTS: Two rounds were needed to achieve the consensus in between the panel members. Then, the index provided a good readability. The EFA suggested a model with 3 factors (diet, exercise and self-analysis) with 7 items which explained 79.16% variance. The results of CFA showed a good fit of SDSCA-Sp. The Internal consistency was moderate to low (α-Cronbach =0.62) and test-retest reliability was evaluated in 198 patients (t=0.462-0.796, p<0.001) with a total correlation of 0.764 (p< 0.0001). CONCLUSIONS: The SDSCA-Sp is used, in a valid way to assess self-care in type 2 DM version in clinical practice and research with similar clinimetric properties to previous studies.

Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial.

UNLABELLED: Pressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances. METHODS AND DESIGN: Main objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain). Sample: 831 immobilised patients at risk of suffering pressure ulcers. RESULTS: The follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55%) vs HOFA 8 (3.08%), ARR 0.53 (-2.2 to 3.26) Right heel: Olive Oil 4 (1.27%) vs HOFA 5 (1.92)%, ARR0.65 (-1.43 to 2.73). Left heel: Olive Oil 3 (0.96%) vs HOFA 3 (1.15%), ARR0.2 (-1.49 to 1.88). Right trochanter: Olive Oil 0 (0%) vs HOFA 4 (1.54%), ARR1.54 (0.04 to 3.03). Left trochanter: Olive Oil 1 (0.32%) vs HOFA 1 (0.38%), ARR0.07 (-0.91 to 1.04). In the intention to treat analysis the lower limit of the established confidence interval was never exceeded. DISCUSSION: The results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome. TRIAL REGISTRATION: Clinicaltrials.gov NCT01595347.

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.

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.