A strategic reflection for the management and implementation of CAR-T therapy in Spain: an expert consensus paper

CAR-T cell therapy represents a therapeutic revolution in the prognosis and treatment of patients with certain types of hematological cancer. However, they also pose new challenges in the healthcare, regulatory and financial fields. The aim of the RET-A project was to undertake a strategic reflection on the management of CAR-T therapies within the Spanish National Health System, to agree on recommendations that will help to better deal with the new context introduced by these cell therapies in the present and in the future. This think tank involved 40 key agents and opinion leaders. The experts identified three great challenges for implementing advanced therapies in Spain: therapeutic individualisation, with a multidisciplinary approach; acceleration of access times, by minimizing bureaucracy; and increase in the number of centers qualified to manage the CAR-T therapies in the NHS. The experts agreed on the ideal criteria for designating those qualified centers. They also agreed on a comprehensive CAR-T care pathway with the timings and roles which would ideally be involved in each part of the process.

Clinical Presentation of the SARS-CoV-2 Virus Infection and Predictive Validity of the PCR Test in Primary Health Care Worker Patients of the Spanish National Health System

Background: Despite the impact that the SARS-CoV-2 virus infection has presented in Spain, data on the diagnostic capacity of the symptoms associated with this infection are limited, especially among patients with mild symptoms and who are detected in the primary care field (PC). The objective of the present study was to know the associated symptoms and their predictive criterial validity in SARS-CoV-2 infection among professionals working in PC. Methods: A cross-sectional, multicenter study was carried out in the Spanish National Health System, through an epidemiological survey directed to patients who underwent the PCR test for SARS-CoV-2 in the PC setting. Results: A total of 1612 patients participated, of which 86.6% were PC healthcare professionals, and of these, 67.4% family doctors. Hyposmia, with a sensitivity of 42.69% (95% CI: 37.30–48.08) and a specificity of 95.91% (95% CI: 94.78–97.03), and ageusia with a sensitivity of 39.47% (34.15–44.80) and a specificity of 95.20% (93.98–96.41) were the symptoms with the highest criteria validity indexes. Conclusions: This study identifies the specific symptoms of loss of smell or taste as the most frequently associated with SARS-CoV-2 infection, essential in the detection of COVID-19 given its high frequency and predictive capacity.

Efficacy of cognitive-behavioral therapy for insomnia: a group format implementation in the Spanish National Health System

Background. Cognitive-behavioral therapy for insomnia (CBT-i) is considered the first-line treatment for this disorder, but it is not widely implemented in clinical settings. This study aims to examine the efficacy of a CBT-i in group format in the Spanish National Health System. Method. Fifty-two participants with a Primary Insomnia Disorder (55.8% women; Mage = 47.19, SD = 11.02) were assigned to a CBT-i (n =17) or waiting list condition (n = 21). Treatment consisted of eight group format sessions (2 hours/week). Results. Significant improvements in insomnia severity, sleep quality, and insomnia-related dysfunctional beliefs and attitudes were observed in patients who received CBT-i. Emotional symptoms also decreased after the intervention in the CBT-i group. Conclusion. Findings support the efficacy of cognitive-behavioral therapy for insomnia with a group protocol for patients with primary insomnia disorder. The maintenance role of insomnia-related dysfunctional beliefs and attitudes in this disorder is also suggested.

Crisis communication in audiovisual format: the information of Spain’s National Health System on YouTube in 2020

Throughout 2020 it has been seen that the Covid-19 pandemic has been an unprecedented health crisis that has involved a major change at both level informative and media. Audiovisual content has increased considerably and there is interest on the part of health institutions to demonstrate their ability as a reliable and first-order source of information. In fact, since the declaration of the pandemic, in just 2 months the number of content disseminated throughout 2019 was exceeded. This study seeks to describe the response given to this health crisis by the Spanish National Health System on YouTube. For this purpose, we analyze the 1035 audiovisual content that the official channels published in 2020. To carry out the analysis, the contents have been classified into 7 types, from press conferences to tutorials, recommendations, informative pieces or testimonies; the topic covered in each of them has been identified, the format, as well as the number of views and user feedback.The period of greatest production corresponds to the first wave and the de-scalding wave, and the health institution that has disseminated the most messages has been the Ministry of Health: 603 vídeos, 170 animations and 263 hybrid pieces –combining real vídeo, text and icons– have been identified. Animations and hybrid pieces are the most successful messages, and are primarily used on an appealing nature to disseminate healthy recommendations and habits. This study values the use of animations as an appropriate information resource for education and health promotion. In addition, it has allowed us to identify the main weaknesses, threats, strengths and opportunities presented by audiovisual health information on YouTube.

Variablity of Mechanical or Tissue Valve Implantation in Patients Undergoing Surgical Aortic Valve Replacement in Spain: National Retrospective Analysis from 2007 to 2018

Background: There is no robust evidence regarding the types of valves implanted among patients undergoing surgical aortic valve replacement (SAVR) in Spain. Methods: All cases of patients undergoing SAVR ± coronary artery bypass grafting from January 2007 to December 2018 in the public Spanish National Health System were included. We analyzed the trends of SAVR volume, risk profile and type of implanted valve across time and place. Using multivariable logistic regression, we identified factors associated with biological SAVR. Results: In total, 62,870 episodes of SAVR in 15 Spanish territories were included. In 35,693 (56.8%), a tissue valve was implanted. The annual volume of procedures increased from 107.3/million (2007) to 128.6 (2017). In 2018, it fell to 108.5. Age increased and Charlson’s comorbity index worsened throughout the study period. Tissue valve implantation increased in most regions. After adjusting for other covariates, we observed a high variability in aortic valve implantation across different regions, with differences of as much as 20-fold in the use of tissue valves. Conclusions: Between 2007 and 2018, we detected a significant increase in the use of bioprostheses in patients undergoing SAVR in Spain, and a great variability in the types of valve between the Spanish territories, which was not explained by the different risk profiles of patients.

Heart Failure Is a Poor Prognosis Risk Factor in Patients Undergoing Cholecystectomy: Results from a Spanish Data-Based Analysis

Background: The incidence of cholecystectomy is increasing as the result of the aging worldwide. Our aim was to determine the influence of heart failure on in-hospital outcomes in patients undergoing cholecystectomy in the Spanish National Health System (SNHS). Methods: We conducted a retrospective study using the Spanish National Hospital Discharge Database. Patients older than 17 years undergoing cholecystectomy in the period 2007–2015 were included. Demographic and administrative variables related to patients’ diseases as well as procedures were collected. Results: 478,111 episodes of cholecystectomy were identified according to the data from SNHS hospitals in the period evaluated. From all the episodes, 3357 (0.7%) were excluded, as the result the sample was represented by 474,754 episodes. Mean age was 58.3 (+16.5) years, and 287,734 (60.5%) were women (p < 0.001). A primary or secondary diagnosis of HF was identified in 4244 (0.89%) (p < 0.001) and mean age was 76.5 (+9.6) years. A higher incidence of all main complications studied was observed in the HF group (p < 0.001), except stroke (p = 0.753). Unadjusted in-hospital mortality was 1.1%, 12.9% in the group with HF versus 1% in the non HF group (p < 0.001). Average length of hospital stay was 5.4 (+ 8.9) days, and was higher in patients with HF (16.2 + 17.7 vs. 5.3 + 8.8; p < 0.001). Risk-adjusted in-hospital mortality models’ discrimination was high in both cases, with AUROC values = 0.963 (0.960–0.965) in the APRG-DRG model and AUROC = 0.965 (0.962–0.968) in the CMS adapted model. Median odds ratio (MOR) was high (1.538 and 1.533, respectively), stating an important variability of risk-adjusted outcomes among hospitals. Conclusions: The presence of HF during admission increases in hospital mortality and lengthens the hospital stay in patients undergoing cholecystectomy. However, mortality and hospital stay have significantly decreased during the study period in both groups (HF and non HF patients).

SUMAMOS EXCELENCIA® Project: Results of the Implementation of Best Practice in a Spanish National Health System (NHS)

The use of certain strategies for the implementation of a specific recommendation yields better results in clinical practice. The aim of this study was to assess the effectiveness of an evidence-based model using clinical audits (GRIP model), for the implementation of recommendations in pain and urinary incontinence management as well as fall prevention, in the Spanish National Health System during the period 2015–2018. A quasi-experimental study has been conducted. The subjects were patients treated in hospitals, primary care units and nursing home centers. There were measures related to pain, fall prevention and urinary incontinence. Measurements were taken at baseline and at months 3, 6, 9, and 12. The sample consisted of 22,114 patients. The frequency of pain assessment increased from 59.9% in the first cycle to a mean of 71.6% in the last cycle, assessments of risk of falling increased from 56.8% to 87.8% in the last cycle; and finally, the frequency of assessments of urinary incontinence increased from a 43.4% in the first cycles to a mean of 62.2% in the last cycles. The implementation of specific evidence-based recommendations on pain, fall prevention, and urinary incontinence using a model based on clinical audits improved the frequency of assessments and their documentation.

Impact of remdesivir for the treatment of COVID-19 during the first wave in Spain

Background: Spain was one of the most affected countries during the first wave of COVID-19, having the highest mortality rate in Europe. The aim of this retrospective study is to estimate the impact that remdesivir -the first drug for COVID-19 approved in EU- would have had in the first wave. Methods: This study estimated the impact on the Spanish National Health System (SNHS) capacity (bed occupancy), and the number of deaths that could have been prevented, based on two scenarios: a real-life scenario (without remdesivir), and an alternative scenario (with remdesivir). It considered the clinical results of the ACTT-1 trial in hospitalized patients with COVID-19 and pneumonia, who required supplemental oxygen. The occupancy rates in general wards and ICUs were estimated in both scenarios. Results: Remdesivir would have avoided the admission of 2,587 patients (43.75%) in the ICUs. It would have also increased the SNHS capacity in 5,656 general wards beds and 1,700 ICU beds, showing an increase in the number of beds available of 17.53% (95% CI: 3.98% - 24.42%), and 23.98% (95% CI: 21.33% - 28.22%), respectively, at the peak of the occupancy rates. Furthermore, remdesivir would have avoided 7,639 deaths due to COVID-19, which implies a 27.51% reduction (95% CI: 14.25% - 34.07%). Conclusions: Remdesivir would have relieved the pressure of the SNHS, and would have reduced the death toll, providing a better strategy for the management of COVID-19 during the first wave.