Impact of the COVID-19 pandemic on cancer screenings in Portugal.

OBJECTIVES: This study aimed to evaluate the impact of the COVID-19 pandemic on cancer screening in Portugal, and its consequences on cancer morbidity and mortality. METHODS: The pre-pandemic and pandemic periods were compared using publicly available data on performance and health outcomes indicators of the Portuguese NHS, namely the numbers and proportions of eligible individuals who underwent cancer screening (breast, cervical or colorectal). Pre-pandemic data were modelled to project hypothetical scenarios without a pandemic using an exponential smoothing algorithm, and then compared with data collected during the COVID-19 pandemic. A Markov model was developed to estimate years of life lost (YLL) due the reduction in the number of cancer screenings during the pandemic. The MS Excel and the PRISM symbolic model checker software were used. RESULTS: There was a decrease in the number of breast (13 %), cervical (15 %) and colorectal (9-11 %) cancers screenings during the first two years of the pandemic. The model projections are 506, 41, and 148 additional deaths, losses of 11, 6, and 4 months of life per patient, and 12.8 thousand, 576, and 4 thousand YLL by the population due to breast, cervical, and colorectal cancer, respectively, over a 25-year time horizon in Portugal. CONCLUSIONS: The disruption in cancer screening may contribute to increase cancer morbidity and mortality, with significant YLL. The long-term implications of the impaired cancer screening should be assessed, and proactive measures put in place to mitigate the increase in cancer morbidity, and mortality associated with the COVID-19 pandemic.

The effectiveness of ibandronate in reducing the risk of nonvertebral fractures in women with osteoporosis: systematic review and meta-analysis of observational studies.

BACKGROUND: Ibandronate is effective in reducing the risk of vertebral fractures, but experimental evidence offers conflicting results regarding nonvertebral fractures. Real-world evidence has been published evaluating the anti-nonvertebral fracture effect of ibandronate. AIM: This meta-analysis of observational studies assessed the effectiveness of ibandronate in reducing the risk of nonvertebral fractures in women with osteoporosis. METHOD: Pubmed/Embase databases were searched for observational studies. Risks of nonvertebral fractures and hip fractures were the outcomes. Meta-analyses were performed pooling rate ratios (RRs), using random-effects models. Data were reanalysed in sensitivity analyses considering Knapp-Hartung method and Bayesian random-effects. RESULTS: Six cohort studies were included. Overall, once-monthly 150 mg oral ibandronate reduced the risk of nonvertebral fractures (RR 0.84; 95% CI 0.76-0.94). Similar results were obtained when the comparison was restricted to once-monthly 150 mg risedronate, but no differences were found when the comparator was other oral bisphosphonates (weekly alendronate/risedronate). Ibandronate didn't significantly change the risk of hip fractures (RR 1.25; 95% CI 0.89-1.76). The risk of hip fracture was comparable between once monthly, 150 mg oral ibandronate and other oral bisphosphonates. Intravenous ibandronate was not effective in reducing hip fractures comparing to intravenous zoledronate. The low number of studies diminished the robustness of sensitivity analyses. CONCLUSION: Results suggest that once-monthly 150 mg oral ibandronate may be as effective as other oral bisphosphonates in reducing the risk of nonvertebral fractures. However, uncertainty associated to the small number of included studies, which are characterized by heterogeneous demographics and methodologies, precluded definitive conclusions.

Topical Janus kinase inhibitors in atopic dermatitis: a safety network meta-analysis.

BACKGROUND: Topical Janus kinase (JAK) inhibitors are being developed for the treatment of mild to moderate atopic dermatitis. However, comparative evidence on their safety profiles is still limited. AIM: This study aimed to compare the relative safety of topic JAK inhibitors in patients with atopic dermatitis. METHOD: Phase 2 and 3 clinical trials (RCTs) evaluating the efficacy and safety of topical JAK inhibitors in atopic dermatitis were searched on Medline, EMBASE and clinicaltrials.gov. The following outcomes were considered: any adverse event (AE), serious AEs, AEs leading to treatment discontinuation, any infection, any application site reaction. RESULTS: Ten RCTs were included in this network meta-analysis. Tofacitinib was associated with a reduced risk of any AE when compared with ruxolitinib (OR 0.18, 95% CrI 0.03-0.92). The analyses for the remaining outcomes did not identify other statistically significant risk differences between the topical JAK inhibitors. CONCLUSION: Although tofacitinib seems to present a reduced risk of any adverse event compared with ruxolitinib, this was the only statistically significant result found between JAK inhibitors. Therefore, such findings should be interpreted with caution considering the scarce data available and the heterogeneity between the studies, and there is no robust evidence allowing pointing out clinically important differences between the safety profiles of the existing topical JAK inhibitors. Further pharmacovigilance activities are needed to confirm the safety profile of these drugs.

Performance of Aptima-HPV in the cervical cancer screening program of Portugal: a cost-analysis.

BACKGROUND: Cervical cancer is a major concern to women's health, being the fourth most common cancer worldwide. A great percentage of these cancer is consequence of an HPV infection, namely from specific genotypes such as 16/18. Portuguese screening program subjects women to a reflex cytology triage every 5 years. Aptima® HPV is a screening test which presents better specificity than other tests which are used in Portugal (Hybrid Capture® 2 and Cobas® 4800) and still have a comparable sensitivity. The present study aims to estimate the number of diagnostic tests and costs that are avoided using Aptima® HPV compared to the use of two other tests, Hybrid Capture® 2 and Cobas® 4800, within the cervical cancer screening programme in Portugal. METHODS: A model, consisting of a decision-tree, was developed to represent the full Portuguese screening program for cervical cancer. This model is used to compare the costs resulting from using Aptima® HPV test versus the other tests used in Portugal, during 2 years. Other outcomes such as the number of additional tests and exams were also computed. This comparison considers the performance of each test (sensitivity and specificity) and assumes an equal price for every test compared. RESULTS: Cost savings resulting from the use of Aptima® HPV are estimated at approximately €382 million versus Hybrid Capture® 2 and €2.8 million versus Cobas® 4800. Moreover, Aptima® HPV prevents 265,443 and 269,856 additional tests and exams when compared with Hybrid Capture® 2 and Cobas® 4800. CONCLUSIONS: The use of Aptima® HPV resulted in lower costs as well as less additional test and exams. These values result from the greater specificity of Aptima® HPV, which signals less false positive cases and consequently avoids carrying out additional tests.

Ibandronate in the Prevention of Vertebral and Nonvertebral Osteoporotic Fractures: A Systematic Review of Experimental and Observational Studies.

BACKGROUND/OBJECTIVE: This study aims to evaluate ibandronate clinical effectiveness in the prevention of osteoporosis-related vertebral fractures (VFs) and nonvertebral fractures (NVFs) in the treatment of postmenopausal osteoporosis. METHODS: This systematic review was conducted in accordance with the Centre for Reviews and Dissemination's guidance and reporting in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement 2020. A literature search was performed in PubMed and EMBASE since their inception until February 7, 2022. Randomized controlled trials (RCTs), meta-analysis, experimental, and observational studies evaluating adult patients treated with ibandronate and assessed to osteoporotic fractures prevention were included. The risk of bias was assessed according to study design. Data were analyzed using descriptive statistics. RESULTS: Eight references from 4 RCTs, 7 meta-analyses, and 6 observational studies were included. In RCTs, oral ibandronate was superior to placebo in the prevention of VF. However, the doses were lower than those approved. The meta-analyses confirmed these results and showed that adequate doses of oral ibandronate reduce the risk of NVF compared with insufficient doses. In observational studies, oral ibandronate (in approved doses) reduced the risk of VF compared with no treatment or risedronate or alendronate and the risk of NVF versus risedronate or alendronate; the risk of hip fractures was similar between ibandronate and other oral bisphosphonates. CONCLUSIONS: There is strong evidence that ibandronate reduces the risk of VF in postmenopausal osteoporosis. The available evidence further suggests that ibandronate may reduce the risk of NVF versus insufficient doses of ibandronate, as well as risedronate or alendronate.

Usability of a telehealth solution based on TV interaction for the elderly: the VITASENIOR-MT case study.

Remote monitoring of biometric data in the elderly population is an important asset for improving the quality of life and level of independence of elderly people living alone. However, the design and implementation of health technological solutions often disregard the elderly physiological and psychological abilities, leading to low adoption of these technologies. We evaluate the usability of a remote patient monitoring solution, VITASENIOR-MT, which is based on the interaction with a television set. Twenty senior participants (over 64 years) and a control group of 20 participants underwent systematic tests with the health platform and assessed its usability through several questionnaires. Elderly participants scored high on the usability of the platform, very close to the evaluation of the control group. Sensory, motor and cognitive limitations were the issues that most contributed to the difference in usability assessment between the elderly group and the control group. The solution showed high usability and acceptance regardless of age, digital literacy, education and impairments (sensory, motor and cognitive), which shows its effective viability for use and implementation as a consumer product in the senior market.

Comparing the Effects of Multicomponent and Concurrent Exercise Protocols on Muscle Strength in Older Adults.

This study aimed to compare the effects of a multicomponent exercise program and a concurrent exercise program on muscle strength in community-dwelling elderly subjects. Participants (n = 35; male = 17; female = 18; Mage = 69.17, SD = 5.01 years) were screened and included in the study. Among them, 19 individuals were assigned to the multicomponent group, while 16 were assigned to the concurrent group. The results of the repeated-measures ANOVA revealed significant main effects for the group factor (F(1,15) = 66.59, p < 0.001, η2 = 0.81) and the group*time factor (F(1,15) = 16.95, p < 0.001, η2 = 0.53) for the 30-second chair test. Furthermore, significant main effects were observed only for the group factor (F(1,15) = 19.28, p < 0.001, η2 = 0.56) for the 30-second arm curl. Regarding the Timed Up and Go test, significant main effects were found for the group factor (F(1,15) = 35.56, p < 0.001, η2 = 0.70) and the group*time factor (F(1,15) = 11.68, p < 0.001, η2 = 0.43). Lastly, significant main effects were observed for the group*time factor (F(1,15) = 5.19, p = 0.038, η2 = 0.25) for handgrip strength. The multicomponent exercise group displayed a greater mean increase compared to the concurrent exercise group. While both the multicomponent and the concurrent exercise programs were effective in improving muscle strength in community-dwelling older adults, the multicomponent exercise group exhibited superior outcomes compared to the concurrent exercise group across the physical fitness measures. These findings suggest that a multicomponent exercise program may be more beneficial for enhancing muscle strength in this population.

The impact of an exercise intervention using low-cost equipment on functional fitness in the community-dwelling older adults: A pilot study.

Exercise interventions have shown significant improvements in the older adult population regarding functional and cognitive capacity. However, much research has applied exercise protocols that are expensive both for research and participation. Thus, high investments that are made are currently not ecologically efficient. The aim of the study was to determine whether the impact of a 20-week multicomponent exercise intervention using low-cost material could improve physical fitness in community-dwelling older adults. We tested the feasibility of this three times per week exercise protocol using an inclusive approach. Eligibility criteria included age ≥65 years, the ability to stand and walk with or without assistive devices, being physically inactive; medical clearance, and living in the community. Outcomes were muscle resistance measured using the chair-stand test for lower limbs, cardiorespiratory capacity measured using the 6-min walk test, and agility and balance using the Timed-up and Go test. Flexibility was measured using the chair sit and reach for lower limbs and the back scratch for upper limbs using the dominant leg and arm, respectively. Hand grip strength was measured using a dynamometer. Thirty participants (n = 30) were recruited and included in the intention-to-treat analysis. The mean age of participants was 70 years (±3.62 years), 100% were Caucasians, and 50% were female. There was a significant trend toward a clinically important improvement in the chair-stand (t = -5.23; p < 0.001; d = 0.36), arm curl (t = -5.21; p < 0.001; d = 0.74), 6-min walk test (t = -4.69; p = <0.001; d = 0.77), timed-up and go test (t = 8.788; p < 0.001; d = 1.18), and hand grip strength (t = 2.846; p = 0.009; d = 0.23). There were also differences in the back scratch (t = 2.243; p = 0.035; d = 0.29) and chair sit and reach test (t = -3.380; p < 0.001; d = 0.15). This pilot study has provided preliminary evidence that a 20-week community-based low-cost exercise program may be effective in improving overall functional fitness in older people. The pilot trial has provided the necessary data to design future randomized-controlled trials that can be implemented in the community in an ecological feasible manner.

The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and network meta-analysis.

PURPOSE: Janus kinase (JAK) inhibitors have been developed to treat moderate to severe atopic dermatitis, but there is little evidence comparing the safety profile of these drugs. The aim of this study is to compare the relative safety of the different systemic JAK inhibitors in atopic dermatitis. METHODS: Medline, EMBASE, and clinicaltrials.gov were searched to identify phase 2/3, clinical trials (RCTs) designed to evaluate the efficacy and safety of systemic JAK inhibitors in atopic dermatitis. Outcomes were the risk of any adverse event (AE), serious AEs, AEs leading to treatment discontinuation, any infection, serious infections, herpes zoster infection, and any cardiac or vascular event. RESULTS: Eighteen RCTs were included. Compared with placebo, baricitinib (odds ratio [OR] 1.25, 95% credible interval [CrI] 1.03-1.55), abrocitinib (OR 1.54, 95% CrI 1.25-1.90), and upadacitinib (OR 1.46, 95% CrI 1.19-1.81) increase the risk of any adverse event. Abrocitinib (OR 1.62, 95% CrI 1.7-2.72), upadacitinib (OR 1.67, 95% CrI 1.19-2.43), and dupilumab (OR 1.69, 95% CrI 1.02-2.79) increase the risk of infections when compared with placebo. Dupilumab has a reduced risk of herpes zoster infection when compared with upadacitinib (OR 0.23; 95% CrI 0.08-0.81) No further statistically significant risk differences between treatments were identified. CONCLUSIONS: The results suggest systemic JAK inhibitors for atopic dermatitis have a similar safety profile. However, as current data present limitations, postmarketing safety evidence will be crucial to draw definitive conclusions regarding the safety of JAK inhibitors.

Talent Identification and Development in Male Futsal: A Systematic Review.

This review aimed to identify and synthesize the most significant literature addressing talent identification and development in futsal. A systematic review of Web of Science™ (all databases), Scopus, PubMed and SPORTDiscus databases was performed according to the preferred reporting items for systematic reviews and meta-analyses guidelines. This study included original articles in English, Spanish or Portuguese containing relevant data on talent development/identification of male futsal players. The search yielded 238 articles. After screening, a total of 32 manuscripts were fully reviewed. The quality of the data reviewed was generally good. Results indicate that the most successful players exhibit technical, tactical, anthropometric, physiological and psychological advantages and are distinguished from lower-level players based on their earlier dedication to training. This review highlights the need for those involved in the process of identifying and developing talented futsal players to consider the technical and tactical skills of futsal players, along with their anthropometric and physiological characteristics, scaled to age. Finally, special attention should be paid to the supportive psychosocial environments created in sports academies for developing futsal players. Overall, talent identification and development programmes in futsal need to be dynamic and offer the possibility of changing assessment parameters in the long term.

Can Group Exercise Programs Improve Health Outcomes in Pregnant Women? An Updated Systematic Review.

Current scientific evidence supports the recommendation to initiate or continue physical exercise in healthy pregnant women. Group exercise programs have positive effects on improving health, well-being, and social support. In 2015, a systematic review was provided to evaluate the evidence on the effectiveness of group exercise programs in improving pregnant women's and newborns' health outcomes and to assess the content of the programs. This review aims to update this knowledge between 2015 and 2020. The exercise program designs were analyzed with the Consensus of Exercise Reporting Template (CERT) model, the compliance with the current guidelines, and effectiveness in the maternal health and fitness parameters. Three databases were used to conduct literature searches. Thirty-one randomized control trials were selected for analysis. All studies followed a supervised group exercise program including aerobic, resistance, pelvic floor training, stretching, and relaxation sections. Group interventions during pregnancy improved health and fitness outcomes for the women and newborns, although some gaps were identified in the interventions. Multidisciplinary teams of exercise and health professionals should advise pregnant women that group exercise improves a wide range of health outcomes for them and their newborns.

The Risk of Infections Associated With JAK Inhibitors in Rheumatoid Arthritis: A Systematic Review and Network Meta-analysis.

BACKGROUND/OBJECTIVE: The Janus kinases (JAKs) are cytoplasmic tyrosine kinases associated with membrane cytokine receptors that mediate signaling of multiple cytokines and growth factors, contributing to the pathogenesis of multiple autoimmune disorders. The JAK inhibitors are a new class of targeted therapies with proven efficacy in treating rheumatoid arthritis but are associated with an increased risk of infections. This study is aimed at comparing the relative safety of the different JAK inhibitors with regard to the risk of serious infections in patients with rheumatoid arthritis. METHODS: PubMed, EMBASE, Cochrane Library, and clinicaltrials.gov were searched to identify randomized controlled trials evaluating the efficacy and safety of JAK inhibitors in patients with rheumatoid arthritis. The outcomes assessed were the risk of total and serious infections, tuberculosis, and herpes zoster. Sensitivity analysis disaggregated the results according to background therapy and licensed doses of JAK inhibitors. RESULTS: Thirty-seven randomized controlled trials that were included met the inclusion criteria. Compared with filgotinib, adalimumab (4.81; 95% confidence interval [CI], 1.39-16.66), etanercept (6.04; 95% CI, 1.79-20.37), peficitinib (7.56; 95% CI, 1.63-35.12), tofacitinib (4.29; 95% CI, 1.43-12.88), and upadacitinib (4.35; 95% CI, 1.46-13.00) have an increased risk of herpes zoster infection. Risk differences between the drugs became statistically nonsignificant when the sensitivity analysis was conducted. CONCLUSIONS: The risk of infections seems to be similar among the currently approved JAK inhibitor drugs. Although the initial results suggested that filgotinib could have a reduced risk of herpes zoster, the sensitivity analyses did not support those findings.

Risk of Cardiovascular and Venous Thromboembolic Events Associated With Janus Kinase Inhibitors in Rheumatoid Arthritis: A Systematic Review and Network Meta-analysis.

BACKGROUND/OBJECTIVE: The Janus kinases are cytoplasmic tyrosine kinases associated with membrane cytokine receptors that mediate signaling of multiple cytokines and growth factors, contributing to the pathogenesis of multiple autoimmune disorders. Janus kinase inhibitors (JKIs) are a new class of targeted therapies with proven efficacy in treating rheumatoid arthritis but are associated with an increased risk of infections. This study is aimed at assessing the risk of cardiovascular and venous thromboembolic events associated with JKIs in patients with rheumatoid arthritis. METHODS: PUBMED, EMBASE, Cochrane Library, and clinicaltrials.gov were searched to identify randomized controlled trials evaluating the efficacy and safety of JKIs in patients with rheumatoid arthritis. The outcomes assessed were the risk of major adverse cardiovascular events, venous thromboembolic events, and any cardiovascular event. Sensitivity analysis disaggregated the results according to background therapy, JKI licensed doses, and studies' methodological quality. RESULTS: Forty-two randomized controlled trials met the inclusion criteria. No statistically significant risk differences were observed between the JKIs for any of the assessed outcomes. Compared with placebo, tofacitinib (odds ratio, 0.32; 95% confidence interval, 0.11-0.89) reduces the risk of venous thromboembolism. The results of the sensitivity analysis are in line with the initial findings. CONCLUSIONS: Current evidence suggests that the risk of cardiovascular and venous thromboembolic events is similar among the JKIs. Postmarketing pharmacovigilance evidence will be of utmost importance in confirming the cardiovascular safety of these drugs.

Parents' and Children's (6-12 Years Old) Physical Activity Association: A Systematic Review from 2001 to 2020.

Worldwide, studies reveal that a significant proportion of adults and children do not meet the recommended guidelines for physical activity (PA). Therefore, it is crucial that proxy determinants for child physical activity enhancement could be identified. Parents have been considered to have a key role in child adherence to physical activity. Thus, this systematic review aimed to identify association between parents' and children's PA. The search of scientific papers was conducted from 31 October 2020 until 31 January 2021, on the Web of Science, Scopus, Psycinfo, SportDiscus, and Pubmed databases. The PRISMA protocol was used. Findings indicate a consistent association between parents' and children's (6-12 years old) PA. Despite the imbalance of the number of assessed fathers and mothers with the latter clearly overrepresented, a trend towards the same gender dyads on PA significant and positive association (father/son, mother/daughter) was evidenced. Results support the relevant importance of parents' PA as role modeling (either explicitly or implicitly) for children's PA. Besides, results revealed the importance of promoting PA in family for the enhancement of children's PA. Moreover, and given the positive impact of exerting PA with the children on children's PA, parents should spend more time practicing PA with their children, especially on MVPA and meeting the recommended guidelines for PA. Future studies should highlight the role of mediator variables on this interaction process, extending the knowledge on the contribution of other factors to the requested enhancement of children adherence to PA practice.

Home-Advantage during COVID-19: An Analysis in Portuguese Football League.

Covid-19 pandemic forced, at the final rounds of 2019-2020 season, in many different sport leagues worldwide, teams to play without an audience. Therefore, the present paper aims to compare the home advantage score in the last ten rounds in 2019-2020 season with the first 24 rounds in same season using Pollard's (1986) and Matos et al.'s (2020) methods. In addition, comparisons across different seasons (2016-2017; 2017-2018; 2018-2019 and 2019-2020) using the same methods were also analyzed. Results showed no differences (p > 0.05) between first 24 rounds and the last 10 in 2019-2020 season as well as in the 3 previous seasons. With Pollard's method, no differences (p > 0.05) were also found among those four seasons on global (all 34 rounds) home advantage. However, a significance difference between 2017-2018 and 2019-2020 (p < 0.05) was founded using Matos et al.'s (2020) method, which is an indicator of the importance of using complementary methods when analyzing the same realities. Overall, despite what might be expectable from recent findings, the lack of an audience in the last 10 rounds of Portuguese Football League 2019-2020 season, due to COVID-19 pandemic, did not affect home advantage. Therefore, future studies could try to analyze other different variables in Portuguese Football League, such as referees' behaviors, rules changing (e.g., the possibility of making five substitutions, instead of three), crowd dimension and density as well as include variables about odds as forecasts in football being played without crowds.

Real-world intensive safety monitoring of biosimilars rituximab and trastuzumab in a Portuguese oncology hospital.

PURPOSE: The aim of this study was to assess the safety profiles of two biosimilar medicines (rituximab and trastuzumab) in the treatment of cancer patients within a Portuguese oncology hospital. METHODS: This hospital-based prospective observational study followed a cohort event monitoring approach focused on signalling suspected adverse drug reactions (ADRs). Patients undergoing treatment with rituximab biosimilar CT-P10 (Truxima®) or trastuzumab biosimilar CT-P6 (Herzuma®) were recruited over an 11-month and a 6-month period, respectively. Clinicians identified eligible patients and used paper-based forms to report all ADRs associated with biosimilar medicines. ADR case reports were assessed for seriousness, expectedness and causality in the Pharmacovigilance Unit of Coimbra. RESULTS: Ninety-four patients received biosimilar medicines (rituximab, n = 35; trastuzumab, n = 59). Of those, 4 patients (11.4%) experienced 16 ADRs with rituximab and 1 patient (1.7%) experienced 5 ADRs with trastuzumab. All case reports contained serious and expected ADRs that were at least probably related with biosimilar medicines under study. Based on the MedDRA PT coding, the most reported ADR for rituximab CT-P10 was chest discomfort (n = 4; 19.1%), followed by odynophagia (n = 2; 9.5%). Trastuzumab CT-P6 was associated with back pain, headache, pain in extremity, tachypnoea and tremor (each, n = 1; 4.8%). CONCLUSION: The results of this study suggest that using biosimilar rituximab and biosimilar trastuzumab to treat cancer patients in the real-world clinical setting is associated with acceptable safety profiles. No new safety problems were identified.

Rectus sheath hematoma in patients receiving subcutaneous enoxaparin: A case series of five patients.

Physicians must acknowledge the potential risk of RSH with enoxaparin. Switching home anticoagulation by enoxaparin upon hospital admission is common, but it may put patients at higher risk for RSH. Management guidelines are needed in this setting.

A Systematic Review of Economic Studies Evaluating Ophthalmic Drugs: An Analysis of the Health-state Utilities.

PURPOSE: To characterize the techniques used to derive health-state utilities (HSU) in the cost-utility studies (CUS) of ophthalmic drugs. METHODS: A systematic review was conducted in Pubmed/Embase until October 2019. CUS evaluating ophthalmic drugs were included. Therapeutic area, technique to derive HSU and sources of HSU were extracted. It was assessed if the HSU and the other parameters of CUS were collected from the same population. The techniques to derive HSU used in the CUS were compared to the techniques recommended by the country-specific economic evaluation guidelines. RESULTS: Seventy CUS were included. Forty-three (61.4%) used direct techniques to derive HSU, 19 (27.1%) used indirect, 1 (1.4%) used direct and indirect and the remaining (n = 7; 10.0%) used other or unknown techniques. Twelve (17.1%) CUS collected the HSU and the other parameters from the same population: nine (12.9%) retrieved utility data from experimental studies, two (2.9%) from observational and one (1.4%) from other sources. Forty-eight (68.6%) CUS collected the HSU and the other parameters from different populations: eight (11.4%) retrieved utility data from experimental studies, 33 (47.1%) from observational, one (1.4%) from both experimental and observational and six (8.6%) from other sources. It was not possible to identify the population from whom data were obtained in 10 (14.3%) CUS. Eleven (15.7%) CUS followed the recommendations of guidelines, 21 (30.0%) did not follow and for 38 (54.3%), it was not possible to assess. CONCLUSION: Choosing different techniques to derive HSU may result in different results, which can preclude the comparison between cost-utility studies.

Spontaneous reports of hypersensitivity adverse drug reactions in Portugal: a retrospective analysis.

BACKGROUND: Hypersensitivity adverse drug reactions (ADRs) are usually serious, unpredictable, and associated with high morbidity and mortality. This study describes cases of hypersensitivity ADRs spontaneously reported in Central Portugal. METHODS: Spontaneous reports (SRs) of ADRs received between 2010 and 2017 were reviewed to identify cases of hypersensitivity reactions, using a Standardized MedDRA Query (SMQ). Seriousness, expectedness, and causality were assessed. Descriptive statistics were used to analyze data. RESULTS: Among 2050 SRs, 598 (29.2%) contained 726 hypersensitivity ADRs: 657 (90.5%) serious, 569 (78.4%) unexpected, and 469 (64.6%) certainly related to drug exposure. Anaphylactic reactions (n = 93; 12.8%), rash maculopapular (n = 82; 11.3%), rash (n = 67; 9.2%) and DRESS (n = 54; 7.4%) were the most common reactions. Frequently implicated drug classes comprised antibiotics (n = 150; 23.0%), antineoplastic agents (n = 124; 19.0%), antigout preparations (n = 54; 8.3%), and anti-inflammatories (n = 44; 6.8%). Top-causative drugs were allopurinol (n = 54; 8.3%), docetaxel (n = 46; 7.1%), and trimethoprim/sulfamethoxazole (n = 26; 4.0%). CONCLUSIONS: Most hypersensitivity ADRs were serious, unexpected, and with strong causal relationship with suspected drugs. Allopurinol was the top-causative drug. Besides antibiotics and anti-inflammatories, antineoplastic agents were frequently cited. These results deserve further investigation.