An Opportunity for Management of Fatigue, Physical Condition, and Quality of Life Through Asynchronous Telerehabilitation in Patients After Acute Coronavirus Disease 2019: A Randomized Controlled Pilot Study.

OBJECTIVE: To compare the preliminary efficacy of asynchronous telerehabilitation in patients after acute coronavirus disease 2019 (COVID-19) on fatigue, physical condition, quality of life, and feasibility of this pilot study with that of a booklet format. DESIGN: Randomized pilot study with 2 intervention arms: asynchronous telerehabilitation group and booklet-based rehabilitation group, with 2 follow-ups at 3 and 6 months. SETTING: Hospital. PARTICIPANTS: Patients discharged after COVID-19 were recruited and evaluated (N=35). INTERVENTIONS: The intervention consisted of a 12-week multimodal rehabilitation program via telerehabilitation or by a booklet. MAIN OUTCOME MEASURES: Fatigue as the main outcome and functional status, quality of life, and feasibility as secondary outcomes were evaluated. RESULTS: After the intervention, there was no significant difference between groups in fatigue, but there were significant differences in favor of the asynchronous telerehabilitation group for the 6-Minute Walk Test (p=.008), the 30-Second Sit-to-Stand Test (p=.019), and physical quality of life (p=.035). These improvements were maintained throughout the 6-month follow-up. Telerehabilitation was shown to be a viable option, without incidents and with a higher adhesion (p=.028) than the booklet format. CONCLUSIONS: A multimodal rehabilitation program by means of asynchronous telerehabilitation appears as a more effective option than traditional formats in improving post-acute COVID-19 sequelae.

Assessing Spaniard men's willingness and determinants to use a male contraceptive pill.

OBJECTIVE: As the clinical trials to develop male contraceptive pills are underway, understanding men's attitudes towards this contraceptive method is transcendental. This research was conducted to identify the degree of willingness and the determinants to use male contraceptive pill among Spaniard men. METHODS: A sample of 402 Spaniards men was presented with 36 scenarios comprising four within-subject factors (cost of pills, pill efficacy, side effects and context). In each scenario, a man is asked by his partner to use the contraceptive pill. Participants indicated their own willingness to use the pill in each circumstance. RESULTS: Cluster analysis revealed that participants took one of seven different positions regarding their willingness to use a contraceptive pill: never agree (10%); mainly depends on pill efficacy (6%); mainly depends on side effects (10%); depends on side effects and efficacy (12%); depends on context and side effects (12%); quite always (25%); always agree (25%). Participants' willingness to use contraceptive pills was more pronounced in the case of mild side effects and higher pill efficacy. CONCLUSION: Fifty percent of participants would use the male pill regardless of the circumstances. Access to this contraceptive method, when available, can contribute to greater equity in reproductive rights of the population.

Quality of Life in Hidradenitis Suppurativa: validation of the HSQoL-24.

To date, there are no disease-specific instruments in Spanish to assess quality of life of patients with hidradenitis suppurativa. A multicentre study was previously carried out in Spain between 2016 and 2017 to develop the Hidradenitis Suppurativa Quality of Life-24 (HSQoL-24), a disease-specific questionnaire to assess quality of life in patients with hidradenitis suppurativa. The objectiv-es of this study are to revalidate the HSQoL-24 in Spanish with a larger sample of patients, and to present the English version. In this multi-centre study in Spain, patients with hidradenitis suppurativa completed the HSQoL-24, the Dermatology Life Quality Index and the Skindex-29. The Hurley staging system was used to assess the severity of the disease. Validation of the questionnaire was carried out in 130 patients, of whom 75 (57.7%) were women. This study demonstrates adequate values of reliability and validity of the HSQoL-24, confirming the previous test re-test validation and making this questionnaire one of wide clinical validity in terms of results perceiv-ed by patients.

Persistence and Use of Ixekizumab in Patients with Psoriatic Arthritis in Real-World Practice in Spain. The PRO-STIP Study.

INTRODUCTION: Ixekizumab (IXE) is an IgG4-type monoclonal antibody targeting IL-17A indicated alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients with insufficient response or with intolerance to one or more disease-modifying anti-rheumatic drug (DMARD) therapy. The PRO-STIP study aimed to describe persistence, patient characteristics, treatment patterns, and effectiveness in patients with PsA receiving IXE in a real-world clinical setting in Spain. METHODS: This was an observational, multicentric, retrospective, longitudinal study in adult PsA patients who started IXE between January 2019 and December 2020, with at least 24 weeks of follow-up. A descriptive analysis of patient characteristics and treatment patterns was performed. The primary objective, treatment persistence, was estimated by Kaplan-Meier survival curve. Effectiveness was evaluated by Disease Activity in Psoriatic Arthritis (DAPSA) scores at baseline and at 12 and 24 weeks. RESULTS: Eighty-nine patients met the selection criteria (55.1% women and mean age 51.5 years). The median time from PsA diagnosis to starting IXE was 7.7 years (IQR 3.4-14.6). Prior to IXE, 95.5% patients had been treated with at least one biologic or targeted synthetic DMARD (b/tsDMARD). The observed persistence rates were 95.5%, 84.3% and 68.5% at 24, 48, and 104 weeks, respectively. The median persistence was not reached in the study period (mean persistence, 86.9 [95% CI 80.6-93.2] weeks). Twenty-eight (31.5%) patients discontinued IXE, 19 patients (21.3%) due to loss of effectiveness and two patients (2.2%) due to adverse events. In patients receiving treatment and with available effectiveness assessment (n = 24), DAPSA decreased significantly from baseline 23.7 (95% CI 19.5-27.9) to 14.8 (95% CI 10.5-19.2) at 12 weeks (p = 0.005) and 14.3 (95% CI 11.1-17.4) at 24 weeks (p = 0.004). CONCLUSIONS: PsA patients treated with IXE in a real-world setting show high treatment persistence through 104 weeks and improvements in disease activity after treatment initiation. This suggests that IXE could be an effective treatment for patients with PsA. RETROSPECTIVELY REGISTERED: Date of registration: 25th May 2021.

A comparative study of treatment interventions for patellar tendinopathy: a secondary cost-effectiveness analysis.

OBJECTIVE: To compare the cost-effectiveness of three patellar tendinopathy treatments. DESIGN: Secondary (cost-effectiveness) analysis of a blinded, randomised controlled trial, with follow-up at 10 and 22 weeks. SETTINGS: Recruitment was performed in sport clubs. The diagnosis and the intervention were carried out at San Jorge University. PARTICIPANTS: The participants were adults between 18 and 45 years (n = 48) with patellar tendinopathy. INTERVENTIONS: Participants received percutaneous needle electrolysis, dry needling or sham needling, all of which were combined with eccentric exercise. MAIN OUTCOME MEASURES: Costs, quality-adjusted life years and incremental cost-effectiveness ratio were calculated for each group. RESULTS: The total cost per session was similar in the three groups: €9.46 for the percutaneous needle electrolysis group; €9.44 for the dry needling group; and €8.96 for the sham group. The percutaneous needle electrolysis group presented better cost-effectiveness in terms of quality-adjusted life years and 96% and 93% probability of being cost-effective compared to the sham and dry needling groups, respectively. CONCLUSION: Our study shows that percutaneous needle electrolysis has a greater probability of being cost-effective than sham or dry needling treatment.

Cost-effectiveness of upper extremity dry needling in the rehabilitation of patients with stroke.

INTRODUCTION: Dry needling (DN) has been shown to be effective for the treatment of upper extremity hypertonia in patients with stroke. PURPOSE: To evaluate the cost-effectiveness of DN in patients with stroke. METHODS: A cost-effectiveness analysis was performed in a research study conducted at a Spanish public hospital where patients were classified into two groups with or without DN. Hypertonia was measured using the Modified Modified Ashworth Scale (MMAS), and quality of life (QOL) was assessed using the EuroQoL 5-dimension questionnaire. Data regarding the effects and costs of physiotherapy were presented by calculating the mean and 95% confidence interval. The health outcomes were evaluated considering the rate of responders to the treatment based on the MMAS. Spanish preference weights were used to estimate quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were calculated to determine the economic value of DN. RESULTS: Eighty patients with stroke in the subacute stage of recovery were selected to participate in this study. Based on the rate of responders, the ICER of the DN group was very low. Despite the sensitivity analysis performed, the results of the ICUR were not encouraging. DISCUSSION: Cost-effectiveness with responder rate results were favourable for the DN group and were confirmed by the sensitivity analysis according to levels of care. In addition, our findings revealed that 4 weeks of treatment could be more cost-effective than 8 weeks. DN treatment of the upper extremity appears to be cost-effective based on the rate of responders measured using the MMAS scale.

Patient Reported Outcome Measure in Atopic Dermatitis Patients Treated with Dupilumab: 52-Weeks Results.

Dupilumab is used to treat atopic dermatitis (AD) patients who have proven to be refractory to previous treatments. The aim of this study was to assess evolution and patient reported outcome measures in adult patients with moderate-to-severe AD treated with dupilumab in routine clinical practice. The outcomes were evaluated and registered at baseline and weeks 16, 40 and 52. The variables evaluated were: disease severity, pruritus, stressful life events, difficulty to sleep, anxiety and depression, quality of life, satisfaction, adherence to the treatment, efficacy and safety. Eleven patients were recruited between 14 Nov 2017 and 16 Jan 2018. Demographic variables: 90% Caucasian, 82% women. Clinical variables: Mean duration of AD = 17.7 (±12.8), 91% had severe disease severity. At baseline, SCORAD median (range) score = 69.2 (34.8-89.2); itch was reported by 100% of patients; itch visual analogue scale median (range) was 9 (6-10); HADS median (range) total score = 13 (5-21); DLQI mean score = 16 (2-27); EQ-5D-3L median (range) = 57 (30-99). At week-52 there was a significant reduction of SCORAD scores median (range) = 4.3 (0-17.1), HADS total score median (range) = 2 (0-10) and improved quality of life EQ-5D-3L median (range) = 89 (92-60). This study confirms that dupilumab, used for 52-weeks under routine clinical practice, maintains the improved atopic dermatitis signs and symptoms obtained at week 16, with a good safety profile.

The Use of HSQoL-24 in an Assessment of Quality-of-Life Impairment among Hidradenitis Suppurativa Patients: First Look at Real-Life Data.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder with well-documented effects on patients' quality of life (QoL). The aim of this study was to evaluate the QoL of patients with HS via the use of a newly developed questionnaire: Hidradenitis Suppurativa Quality of Life-24 (HSQoL-24). This study was performed on a population of 342 HS patients. Their QoL was assessed via the HSQoL-24 questionnaire. The perceived impairment of QoL due to HS in the studied group was considered to be serious (mean HSQoL-24 score: 58.3 ± 21.0 points). Women tended to experience a significantly higher impact from the disease than men (61.6 ± 19.2 points vs. 51.1 ± 23.1 points, p < 0.001). The HS severity had an effect on the perceived QoL, with statistically significant differences being evident between the self-assessed HS severity groups. The level of QoL impairment correlated positively with the number of affected body areas (r = 0.285, p < 0.001) and the duration of the disease (r = 0.173, p = 0.001), while the patients' age at disease onset correlated negatively with the HSQoL-24 global score (r = -0.182, p = 0.001). Patients living in their family house scored higher than other groups. The least affected were patients who lived alone. The study shows that the HSQoL-24 questionnaire is a reliable, HS-specific tool for measuring the QoL among patients with HS in real-life clinical settings.

Cost of Venous Thromboembolic Disease in Patients with Lung Cancer: Costecat Study.

BACKGROUND: Patients with lung cancer (LC) are at significantly higher risk of developing venous thromboembolism (VTE), which may lead to increased use of health resources and the cost of management. The main aim of the study was to determine the cost of the management of VTE events in patients with LC treated with Low Molecular Weight Heparins (LMWH) in Spain. METHODS: Costecat was an, observational, ambispective pharmacoeconomic study. Patients with LC, with a first episode of VTE (symptomatic or incidental) in treatment with LMWH, were recruited from six third-level hospitals and followed up for six months. Sociodemographic, clinical and resource use variables of VTE-related implications and its treatment were collected. Direct healthcare costs and direct non-healthcare costs were recorded. Data collection was documented in an electronic case report. Unit costs were obtained from national databases. Costs (€2018) were estimated from the healthcare perspective. Statistical analysis was performed using the statistical program R 3.4.3 version (30 November 2017). RESULTS: Forty-seven patients were included. Mean age was 65.4 years, 66.0% were male. The percentage of patients with LC who had metastatic disease was 78.7%. Twenty-three patients (48.9%) needed hospital admissions due to thromboembolic episode. Total average cost of patients with cancer associated VTE (CAT) was €109,696.6 per patient/semester. The hospitalizations represent 65.8% of total costs (7207.3 € SD 13,996.9 €), followed by LMWH therapy which represents 18.6% (2033.8 € SD:630.5 €). CONCLUSIONS: Venous thromboembolism episodes induce an economic impact on patients and healthcare systems. Direct healthcare costs are the major burden of the total cost, in which hospitalizations are the main drivers of cost.

Correlation and regression analysis between residual gradation and uncorrected visual acuity one year after refractive surgery with LASIK, FS-LASIK, PRK, PRK Xtra techniques and the implantation of ICL® posterior chamber phakic lens in myopic correction.

PURPOSE: To analyze the influence of the final spherical equivalent (SE) in LogMAR uncorrected distance visual acuity (UDVA) one year after refractive surgery. We analysed refractive results, their predictability and efficacy, and the safety results of the different methods as secondary outcomes. SETTING: Refractive Surgery Unit of the Institut Català de Retina (ICR) in Barcelona, Spain. DESIGN: Retrospective, analytical observational study. METHODS: Retrospective and observational study of 654 eyes of 327 patients who underwent refractive surgery to treat their myopia or myopic astigmatism using LASIK, FS-LASIK, PRK, PRK Xtra or ICL-type lens implantation surgery were included. RESULTS: The correlation between the SE in absolute value was statistically significant in all techniques utilized, reaching higher values in the FS-LASIK and LASIK techniques, 0.774 and 0.706 respectively, and lesser values in PRK (0.480) and PRK Xtra (0.482). A significant adjustment via a univariate linear regression model could be implemented in all techniques, albeit the R2 coefficient of determination values were higher than those for the FS-LASIK (0.599) and LASIK (0.494) techniques. CONCLUSIONS: There is a positive correlation between post-surgical SE value and post-operative LogMAR UDVA. These regression models can be adjusted to predict the final UDVA according to the final SE. The techniques that are most influenced by the final SE in terms of their visual results are FS-LASIK and LASIK.

[Relationship between allogeneic blood transfusion, iron deficiency and nosocomial infection in patients with hip fracture]. / Relación de la transfusión y la ferropenia con la infección nosocomial en pacientes con fractura de cadera.

BACKGROUND AND OBJECTIVE: To know the frequency of nosocomial infection (NI) in surgical hip fracture patients and to analyze the risk factors that favor the NI development, especially its relationship with allogeneic blood transfusion (ABT) and intravenous iron administration. PATIENTS AND METHOD: Unicenter prospective observational study of all hip fracture surgery patients during 8 months. The demographic, clinical and hematimetric differences between the infected and not infected patients were described. A logistic regression analysis was made to know the variables that predicted NI development. RESULTS: 26.1% of all 286 patients studied developed NI, urinary infection being the most frequent. The existence of lower hemoglobin or ferritin levels at admission, as well as increased values in ASA (American Society of Anesthesiologists) scale were associated with a greater risk of NI development. ABT and the number of red blood cell units transfused were also associated with an increase of the NI risk. No relationship between intravenous iron administration and NI was found. CONCLUSIONS: Lower haemoglobin and ferritin levels and ABT are associated with an increasing NI risk in surgical hip fracture patients. Thus, in order to decrease the frequency of NI in surgical patients, the development of blood saving protocols including intravenous iron administration would be recommendable.

[Budget impact analysis of a blood saving program for urgent traumatological surgery]. / Análisis del impacto presupuestario de la implantación de medidas de ahorro de sangre en cirugía de urgencia.

BACKGROUND AND OBJECTIVE: To assess the cost-effectiveness and the budget impact of a Blood Saving Program (BSP) in patients older than 65 undergoing perthrocanteric hip fracture surgery. PATIENTS AND METHOD: Two groups of patients with perthrocanteric fracture were included. Group 1: patients not receiving treatment for perisurgical anaemia or treated with oral iron; Group 2: patients included in a BSP (treatment with endovenous iron sucrose and alfa epoetin, plus restrictive transfusional criteria). Effectiveness issues were: transfusion rate and number of red blood cell units transfused, length of postoperative stay and infection rate. Treatment cost was calculated using drug and transfused red blood cell unit prizes in 2003. We calculated potential patient population according to 2003 data. RESULTS: 144 patients were included, 43 of which were in the BSP. Both groups were comparable in gender, age, preoperative length of stay, ASA and haemoglobin level at admission. Patients included in the BSP were less transfused and had less infections but postoperative stay was similar in both groups. The budget impact was 239,148 euros 95% [confidence interval (CI) 202,312-311,980] at group 1 and 311,980 euros [95% CI 275,288-348,672] at the BSP group. Including the whole potential population in the BSP (during one year 400 patients) would mean a cost increase of 72,832 euros, avoiding transfusion in 92 patients, infection in 70 patients, and saving 328 red blood cell units. CONCLUSIONS: The cost increase due to endovenous iron sucrose and alfa-epoetin can be considered affordable for the hospital budget. BSP provides lower transfusion and infection rates and saves red blood cell units, compared to the standard procedure. Differences in postoperative stay should be analyzed in further larger and prospective studies including more patients.

Cost analysis of biologic drugs in rheumatoid arthritis first line treatment after methotrexate failure according to patients' body weight. / Análisis de costes de la utilización de fármacos biológicos para la artritis reumatoide en primera línea de tratamiento tras respuesta inadecuada a metotrexato en función del peso de los pacientes.

OBJECTIVE: The objective was to assess the influence of patients' weight in the cost of rheumatoid arthritis treatment with biologic drugs used in first line after non-adequate response to methotrexate. PATIENTS AND METHOD: Pharmaceutical and administration costs were calculated in two scenarios: non-optimization and optimization of intravenous (IV) vials. The retrospective analysis of 66 patients from a Spanish 1,000 beds-hospital Rheumatology Clinic Service was used to obtain posology and weight data. The study time horizon was two years. Costs were expressed in 2013 euros. RESULTS: For an average 69kg-weighted patient the lowest cost corresponded to abatacept subcutaneous (SC ABA) (€21,028.09) in the scenario without IV vials optimization and infliximab (IFX) (€20,779.29) with optimization. Considering patients' weight in the scenario without IV vials optimization infliximab (IFX) was the least expensive drug in patients ranged 45-49kg, IV ABA in 50-59kg and SC ABA in patients over 60kg. With IV vials optimization IFX was the least expensive drug in patients under 69kg and SC ABA over 70kg. CONCLUSIONS: Assuming comparable effectiveness of biological drugs, patient's weight is a variable to consider, potentials savings could reach €20,000 in two years.

[Determination of isothermal areas and selection of representative weather stations in Aragon as a basis for estimating the impact of climate change on the possible relationship between mortality and temperature]. / Determinación de zonas isotérmicas y selección de estaciones meteorológicas representativas en Aragón como base para la estimación del impacto del cambio climático sobre la posible relación entre mortalidad y temperatura.

BACKGROUND: In extensive and diversified regions, such as Aragon, it is believed the need to divide them into areas in terms of the available atmospheric variables with a view to select a representative weather station. The objective of this study was to determine the existence of isothermal regions and select representative stations for Aragon in order to carry out further study on the correlation between variables of temperature and daily mortality. METHODS: Daily data on maximum and minimum temperature for the period between January 1987 and December 2006 was selected. In order to determine the isothermal areas a cluster analysis and a discriminate factor analysis were carried out along with a data pretreatment of filled gaps and detection of inhomogeneities in the climatic series. We analyzed data from 93 stations (44 in Huesca, 15 in Teruel and 34 in Zaragoza). RESULTS: The results of the analysis for the regionalization of Aragon lead us to conclude that a unique factor explains the variance of each series; at high temperatures one factor explains 93.43% of the variance and the station with the highest correlation factor is Monflorite-Huesca (correlation = 0.984). At low temperatures one factor explains 90.88% of the variance, with Monegros-Pallaruelo being the station that presents the greatest correlation factor (correlation = 0.976). CONCLUSIONS: It was felt that Aragon was a unique isothermal region with one unique representative station of the temperature variability, Zaragoza-Airport with a correlation of 0.980 in maximum temperatures and 0.974 minimum.