Corneal diseases are among the main causes of blindness, with approximately 4.6 and 23 million patients worldwide suffering from bilateral and unilateral corneal blindness, respectively. The standard ...treatment for severe corneal diseases is corneal transplantation. However, relevant disadvantages, particularly in high-risk conditions, have focused the attention on the search for alternatives.
We report interim findings of a phase I-II clinical study evaluating the safety and preliminary efficacy of a tissue-engineered corneal substitute composed of a nanostructured fibrin-agarose biocompatible scaffold combined with allogeneic corneal epithelial and stromal cells (NANOULCOR). 5 subjects (5 eyes) suffering from trophic corneal ulcers refractory to conventional treatments, who combined stromal degradation or fibrosis and limbal stem cell deficiency, were included and treated with this allogeneic anterior corneal substitute.
The implant completely covered the corneal surface, and ocular surface inflammation decreased following surgery. Only four adverse reactions were registered, and none of them were severe. No detachment, ulcer relapse nor surgical re-interventions were registered after 2 years of follow-up. No signs of graft rejection, local infection or corneal neovascularization were observed either. Efficacy was measured as a significant postoperative improvement in terms of the eye complication grading scales. Anterior segment optical coherence tomography images revealed a more homogeneous and stable ocular surface, with complete scaffold degradation occurring within 3–12 weeks after surgery.
Our findings suggest that the surgical application of this allogeneic anterior human corneal substitute is feasible and safe, showing partial efficacy in the restoration of the corneal surface.
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•NANOULCOR human bioartificial corneas can be surgically implanted in human patients.•Bioartificial human corneas are highly biocompatible and free from side effects.•Preliminary signs of efficacy were found in the first cases grafted with NANOULCOR.
ObjectivesSuccessful 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.DesignCross-sectional validation study.SettingPrimary care settings in Málaga (Spain).ParticipantsA sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study.Main outcome measuresIn 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.ResultsConfirmatory 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).ConclusionsThe Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.
Depression is one of the most common mental disorders and will become one of the leading causes of disability in the world. Internet-based CBT programs for depression have been classified as "well ...established" following the American Psychological Association criteria for empirically supported treatments. The aim of this study is to analyze the cost effectiveness at 12-month follow-up of the Internet-based CBT program "Smiling is fun" with (LITG) and without psychotherapist support (TSG) compared to usual care. The perspective used in our analysis is societal. A sample of 296 depressed patients (mean age of 43.04 years; 76% female; BDI-II mean score = 22.37) from primary care services in four Spanish regions were randomized in the RCT. The complete case and intention-to-treat (ITT) perspectives were used for the analyses. The results demonstrated that both Internet-based CBT interventions exhibited cost utility and cost effectiveness compared with a control group. The complete case analyses revealed an incremental cost-effectiveness ratio (ICER) of €-169.50 and an incremental cost-utility ratio (ICUR) of €-11389.66 for the TSG group and an ICER of €-104.63 and an ICUR of €-6380.86 for the LITG group. The ITT analyses found an ICER of €-98.37 and an ICUR of €-5160.40 for the TSG group and an ICER of €-9.91 and an ICUR of €496.72 for the LITG group. In summary, the results of this study indicate that the two Internet-based CBT interventions are appropriate from both economic and clinical perspectives for depressed patients in the Spanish primary care system. These interventions not only help patients to improve clinically but also generate societal savings.
clinicaltrials.gov NCT01611818.
Background
Community pharmacy services play an important role in controlling some factors related to medicine use and patients can benefit from these services to improve the adherence and knowledge ...of their medications, besides to reduce medicine-related problems.
Objective
The aim of the REVISA project is to carry out a study on preliminary implementation of the medicines use review service in Spanish community pharmacies.
Setting
Sixty-four community pharmacies from all regions of Spain.
Method
A preliminary implementation, cross-sectional multicentre study was conducted using a convenience sample of voluntary community pharmacies. A structured interview enabled to pharmacists to obtain a better understanding of patient’s medicines use.
Main outcome measure
Medicines use review-related time and cost, satisfaction and willingness to pay.
Results
A total of 495 patients were enrolled. The mean age of the patients was 66.1 years, with the majority females (56.4%) and a mean consumption of 5.7 medicines. A total of 2811 medicines were evaluated and 550 referral recommendations were made (29.8% to Primary Care). The mean time employed by the pharmacists in the medicines use review service was 52.8 min (medicines use review-related cost of €17.27). Most patients expressed a high level of satisfaction with this service (98.5%) and a willingness to pay for it (84%).
Conclusion
Medicines use review service in community pharmacies in Spain can be delivered, that it appears to be acceptable to patients and that most patients said they would be willing to pay for it. This service may offer an opportunity to promote inter-professional collaboration between pharmacists and general practitioners.
In the field of health, the year 2020 will be remembered for testing (stressing) all health institutions and their forms of management (centralised and decentralised). The everyday activity of ...primary and hospital care was significantly altered by the introduction of telephone consultations, which reduce the number of visits to health centres or hospitals and are still relevant today in the face of successive waves of the pandemic.
To analyse whether population confinement due to the COVID-19 pandemic had an impact on the dispensing of medications in community pharmacies and the associated spending during the period March-July 2020 in Andalusia (Spain).
A time series analysis applying econometric model analysis techniques to confirm or rule out whether the lockdown caused by the COVID-19 pandemic had an impact on the dispensing of medications by community pharmacies and the associated expenditures. The variables used were the number of medication containers dispensed by community pharmacies (charged to the public funds of the Spanish National Health System) and the expenditure on prescription drugs, both in relation to the population. The analysis was performed within the region of Andalusia, which has 8,464,441 inhabitants.
The data obtained from the time series confirmed that there were no significant differences during the studied period between the number of medication containers actually dispensed and the number that would have been expected to be dispensed according to the trend in this variable for the sample period. The expenditure results followed the same pattern.
The health crisis produced by the COVID-19 lockdown had no impact on medication consumption in Andalusia.
In Andalusia, the right to maximum waiting times for healthcare clashes with the available supply, leading to an increase in demand in the form of waiting lists. To address this situation, the ...activity of private centers has been created for certain diagnostic tests. The Social Return on Investment (SROI) model evaluates an intervention from an economic and stakeholder perspective. However, there are no studies on the suitability of waiting lists using SROI, which is why it is intended to be studied as a decision-making tool for the clinical and healthcare management of waiting lists. This research protocol is designed to determine the quality of life gained, with the EuroQol-5D-5L questionnaire, and its social assessment, with the specific survey of the SROI method, and, thus, analyze the social return on investment and determine the suitability of the intervention (diagnostic endoscopy activity arranged in a contracted center). After the study, we will know the economic (cost in public health centers and the incremental cost of extraordinary health resources), social (quality of life with health), and environmental scenarios of the concerted activity intervention in order to adjust waiting list times.
Psoriasis is a chronic, systemic inflammatory disease that affects the skin, with a high impact on patients' quality of life. The aim of this study was to identify and determine the relative ...importance of unmet needs in the management of moderate-to-severe psoriasis in Spain, from a multi-stakeholder perspective. A mixed method-approach was used to collect information, design a questionnaire and a discrete-choice exercise, and elicit the unmet needs through a multidisciplinary committee composed of 12 experts. A total of 65 unmet needs were identified and categorized into 4 areas: clinical, patient-related, decision-making process, and social. Decision-making process unmet needs were perceived as the most pressing ones, followed by social, clinical and patient-related. Individually, the need to incorporate outcomes that are important to the patients and to have treatments that achieve total clearance with a rapid onset of action and long-term persistence were the most important unmet needs.
Between 15% and 30% of HIV‐infected subjects fail to increase their CD4+ T‐cell counts despite continuous viral suppression (immunological nonresponders INRs). These subjects have a higher morbidity ...and mortality rate, but there are no effective treatments to reverse this situation so far. This study used data from an interrupted phase I/II clinical trial to evaluate safety and immune recovery after INRs were given four infusions, at baseline and at weeks 4, 8, and 20, with human allogeneic mesenchymal stromal cells from adipose tissue (Ad‐MSCs). Based on the study design, the first 5 out of 15 INRs recruited received unblinded Ad‐MSC infusions. They had a median CD4+ nadir count of 16/μL (range, 2‐180) and CD4+ count of 253 cells per microliter (171‐412) at baseline after 109 (54‐237) months on antiretroviral treatment and 69 (52‐91) months of continuous undetectable plasma HIV‐RNA. After a year of follow‐up, an independent committee recommended the suspension of the study because no increase of CD4+ T‐cell counts or CD4+/CD8+ ratios was observed. There were also no significant changes in the phenotype of different immunological lymphocyte subsets, percentages of natural killer cells, regulatory T cells, and dendritic cells, the inflammatory parameters analyzed, and cellular associated HIV‐DNA in peripheral blood mononuclear cells. Furthermore, three subjects suffered venous thrombosis events directly related to the Ad‐MSC infusions in the arms where the infusions were performed. Although the current study is based on a small sample of participants, the findings suggest that allogeneic Ad‐MSC infusions are not effective to improve immune recovery in INR patients or to reduce immune activation or inflammation. ClinicalTrials.gov identifier: NCT0229004. EudraCT number: 2014‐000307‐26.
Between 15%‐30% of HIV‐infected subjects, do not achieve a significant immune recovery despite continuous viral suppression (immunological non‐responders). These subjects have an aberrant state of immune activation and inflammation. The treatment with adipose tissue allogeneic adult mesenchymal stromal cells does not neither improve immune recovery, nor has it succeeded in reducing the state of immune activation and inflammation.
The action of tyrosinase on ortho-substituted monophenols (thymol, carvacrol, guaiacol, butylated hydroxyanisole, eugenol, and isoeugenol) was studied. These monophenols inhibit melanogenesis because ...they act as alternative substrates to l-tyrosine and l-Dopa in the monophenolase and diphenolase activities, respectively, despite the steric hindrance on the part of the substituent in ortho position with respect to the hydroxyl group. We kinetically characterize the action of tyrosinase on these substrates and assess its possible effect on browning and melanognesis. In general, these compounds are poor substrates of the enzyme, with high Michaelis constant values, K m, and low catalytic constant values, k cat, so that the catalytic efficiency k cat/K m is low: thymol, 161 ± 4 M–1 s–1; carvacrol, 95 ± 7 M–1 s–1; guaiacol, 1160 ± 101 M–1 s–1.
Patients with schizophrenia and related disorders (SRD) are more predisposed to having cardiovascular risk factors (CVRFs) compared to the general population due to a combination of lifestyle factors ...and exposure to antipsychotic medications. We aimed to analyse the documentation practices of CVRFs by general practitioners (GPs) and its associations with patient variables in a sample of persons with SRD.
An observational, cross-sectional study was conducted in 13 primary care centres (PCCs) in Malaga (Spain). The population comprised all patients with SRD who were in contact with a GP residing in the study area. The number of CVRFs (type 2 diabetes mellitus, hypertension, hypercholesterolaemia, obesity and smoking) recorded by GPs were analysed by considering patients' demographic and clinical variables and use of primary care services. We performed descriptive, bivariate and multivariate regression analyses.
A total of 494 patients were included; CVRFs were not recorded in 59.7% of the patients. One CVRF was recorded in 42.1% of patients and two or more CVRFs were recorded in 16.1% of patients. Older age, living in an urban area and a higher number of visits to the GP were associated with a higher number of CVRFs recorded.
The main finding in this study is that both patients' demographic variables as well as use of primary care services were found to be related to the documentation of CVRFs in patients with SRD by GPs.
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