Do PHI and PHI density improve detection of clinically significant prostate cancer only in the PSA gray zone?

OBJECTIVES: Prostate health index (PHI) is a predictive biomarker of positive prostate biopsy. The majority of evidence refers to its use in the PSA gray zone (4-10 ng/mL) and negative digital rectal exam (DRE). We aim to evaluate and compare the predictive accuracy of PHI and PHI density (PHId) with PSA, percentage of free PSA and PSA density, in a wider range of patients for the detection of clinically significant prostate cancer (csPCa). METHODS: Multicenter prospective study that included patients suspicious of harboring prostate cancer. Non-probabilistic convenience sampling, where men who attended the urology consultation were tested for PHI before prostate biopsy. To evaluate and compare diagnostic accuracy AUC and decision curve analysis (DCA) were calculated. All these procedures were performed for the overall sample and the following subsamples: PSA < 4 ng/ml; PSA 4-10 ng/ml; PSA 4-10 ng/ml plus negative DRE and PSA > 10 ng/ml. RESULTS: Among the 559 men included, 194 (34.7%) were diagnosed of csPCa. PHI and PHId outperfomed PSA in all subgroups. PHI best diagnostic performance was found in PSA 4-10 ng/ml with negative DRE (sensitivity 93.33, NPV 96.04). Regarding AUC, significant differences were found between PHId and PSA in the subgroup of PSA 4-10 ng/ml, whatever DRE status. In DCA, PHI density shows the highest net benefit. CONCLUSIONS: PHI and PHId outperfom PSA in csPCa detection, not only in the PSA grey zone with negative DRE, but also in a wider range of PSA values. There is an urgent need of prospective studies to established a validated threshold and its incorporation in risk calculators.

Cost-effectiveness and epidemiological impact of gender-neutral HPV vaccination in Spain.

All EU countries have introduced Human papilloma virus (HPV) vaccination for adolescent girls and many countries are expanding the strategy to include adolescent boys. There is uncertainty about the cost-effectiveness and epidemiological impact of a gender-neutral HPV vaccination strategy. Here we present the results of an economic model adapted for Spain. Five vaccination strategies were compared from the Spanish healthcare system perspective, combining two vaccines (4-valent and 9-valent) in a gender-neutral or girls-only programme in a dynamic population-based model with a discrete-time Markov approach. Costs and benefits were discounted at 3%. The benefits of immunization were measured with quality-adjusted life years (QALYs), which are achieved by reducing the incidence of diseases attributable to HPV. Incremental cost-effectiveness ratio (ICER) was compared with the willingness-to-pay threshold in Spain. The two most effective strategies were compared: gender-neutral 9-valent vaccination vs. girls-only 9-valent vaccination, resulting in an ICER of € 34,040/QALY, and an important number of prevented cases of invasive cancers and anogenital warts. The sensitivity analysis revealed that gender-neutral 9-valent vaccination would become cost-effective if protection against oropharyngeal and penile cancers was included or if the price per dose decreased from €45 to €28. The gender-neutral 9-valent HPV vaccination in Spain offers more benefits than any other modeled strategy, although in the conservative base case it is not cost-effective. However, certain plausible assumptions would turn it into an efficient strategy, which should be borne in mind by the decision makers together with equity and justice arguments.

What is the context? Human papillomavirus (HPV) is a group of viruses that causes sexually transmitted diseases, including certain cancers. European countries offer HPV vaccination to adolescent girls.Many countries have also introduced the vaccination in adolescent boys.There are doubts about whether it is worth vaccinating adolescents of both genders.What this study adds? We estimated costs and benefits of the vaccination in Spain, comparing two types of vaccine, only in girls and in both genders. This analysis considered indirect protection of vaccinated people to unvaccinated ones.It seems that the benefits of HPV vaccination in all adolescents do not compensate the costs.However, when we included likely protection against additional cancers or we reduced the price per vaccine dose, it would be worth vaccinating all adolescents in Spain.We also stated ethical arguments in favor of HPV vaccination for both genders.What is the impact? HPV vaccination in adolescent boys and girls in Spain will prevent more HPV-related diseases.For certain scenarios, HPV vaccination in both genders would be worth in Spain.Ethically, vaccinating also boys would be fair, equitable and would not discriminate a part of the population.

Relevance of well-being, resilience, and health-related quality of life to mental health profiles of European adolescents: results from a cross-sectional analysis of the school-based multinational UPRIGHT project.

PURPOSE: The existing evidence suggests that a complete evaluation of mental health should incorporate both psychopathology and mental well-being indicators. However, few studies categorize European adolescents into subgroups based on such complete mental health data. This study used the data on mental well-being and symptoms of mental and behavioral disorders to explore the mental health profiles of adolescents in Europe. METHODS: Data collected from adolescents (N = 3767; mean age 12.4 [SD = 0.9]) from five European countries supplied the information on their mental well-being (personal resilience, school resilience, quality of life, and mental well-being) and mental and behavioral disorder symptoms (anxiety, depression, stress, bullying, cyber-bullying, and use of tobacco, alcohol, or cannabis). Multiple correspondence analysis and cluster analysis were combined to classify the youths into mental health profiles. RESULTS: Adolescents were categorized into three mental health profiles. The "poor mental health" profile (6%) was characterized by low levels of well-being and moderate symptoms of mental disorders. The "good mental health" profile group (26%) showed high well-being and few symptoms of mental disorders, and the "intermediate mental health" profile (68%) was characterized by average well-being and mild-to-moderate symptoms of mental disorders. Groups with higher levels of well-being and fewer symptoms of mental disorders showed lower rates of behavioral problems. Mental well-being indicators strongly contributed to this classification. CONCLUSION: Adolescents with the "intermediate" or "poor" mental health profiles may benefit from interventions to improve mental health. Implications for school-based interventions are discussed. TRIAL REGISTRATION NUMBER (TRN) AND DATE OF REGISTRATION: ClinicalTrials.gov Identifier: NCT03951376. Registered 15 May 2019.

Cost-effectiveness of extending the HPV vaccination to boys: a systematic review.

BACKGROUND: Human papillomavirus (HPV) infection can have severe consequences both in women and men. Preadolescent girls are vaccinated against HPV worldwide but a gender-neutral vaccination is being adopted only little by little. This systematic review offers an overview of cost-effectiveness of the gender-neutral HPV vaccination. METHODS: Economic evaluations of gender-neutral HPV vaccination with a two-dose schedule compared with girls-only strategy were systematically searched in Medline, Embase and WOS up to June 2020. Incremental cost-effectiveness ratios and key parameters were analysed. RESULTS: Nine studies met the inclusion criteria. Four studies concluded in favour of the gender-neutral programme, another four found it cost-effective only in alternative scenarios. The most influential parameters are the discount rate of benefits (same as for costs vs reduced), vaccine price (listed vs publicly negotiated) and included health problems (inclusion of oropharyngeal and penile cancers). Sponsorship was not decisive for the final result, but there were differences between industry-funded and independent studies in some cost categories. CONCLUSIONS: The evidence of the cost-effectiveness of extending HPV vaccination to boys is scarce and ambiguous. Before the adoption of such a strategy, countries should carry out context-specific cost-effectiveness analyses, but the decision should also take into account other criteria, such as gender-related equality.

UPRIGHT, a resilience-based intervention to promote mental well-being in schools: study rationale and methodology for a European randomized controlled trial.

BACKGROUND: Adolescence is crucial period for laying the foundations for healthy development and mental well-being. The increasing prevalence of mental disorders amongst adolescents makes promotion of mental well-being and prevention interventions at schools important. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is designed as a whole school approach (school community, students and families) to promote a culture of mental well-being and prevent mental disorders by enhancing resilience capacities. The present article aims at describing the rationale, conceptual framework, as well as methodology of implementation and evaluation of the UPRIGHT intervention. METHODS: UPRIGHT project is a research and innovation project funded by the European Union's Horizon 2020 Research and Innovation programme under grant agreement No. 754919 (Duration: 48 months). The theoretical framework has been developed by an innovative and multidisciplinary approach using a co-creation process inside the UPRIGHT Consortium (involving seven institutions from Spain, Italy, Poland, Norway, Denmark, and Iceland). Resulted is the UPRIGHT programme with 18 skills related to 4 components: Mindfulness, Coping, Efficacy and Social and Emotional Learning. Among the five Pan-European regions, 34 schools have been currently involved (17 control; 17 intervention) and around 6000 adolescents and their families are foreseen to participate along a 3-year period of evaluation. Effectiveness of the intervention will be evaluated as a randomized controlled trial including quantitative and qualitative analysis in the five Pan-European regions representative of the cultural and socioeconomic diversity. The cost-effectiveness assessment will be performed by simulation modelling methods. DISCUSSION: We expect a short- to medium-term improvement of mental well-being in adolescents by enhancing resilience capacities. The study may provide robust evidence on intrapersonal, familiar and social environmental resilience factors promoting positive mental well-being. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03951376 . Registered 15 May 2019.

Observational Study Evaluating the Economic Impact of Breakthrough Pain in Cancer Patients in Clinical Practice in Spain: The IMDI Study.

INTRODUCTION: Breakthrough pain (BTP) has great repercussions on the quality of life, and on the use of health resources. The scope of BTP costs in cancer patients is unknown. The purpose of this study was to evaluate the economic cost of BTP in patients with cancer and the relationship with their quality of life. METHODS: A 1-month observational prospective cost-of-illness study was designed. The patients recorded the consumption of health resources and drugs related to BTP in a diary. The current symptoms in Edmonton Symptoms Assessment Scale (ESAS) and their quality of life (EORTC QLQ-C30, version 3) were assessed. The direct medical and non-medical costs fixed and variable and the indirect costs of the patient and the caregivers were evaluated. Factors related to cost and quality of life were identified using linear generalized models (LGM) type gamma and logistic link. Participants were oncologic patients with BTP, older than 18 years, with controlled basal pain. RESULTS: Eight Spanish pain units, eight palliative care units, and one oncology department included 152 patients. One hundred patients (65.8%) were male and the mean age was 66.8 years (95% CI 64.8-68.8). The total cost per patient was 2941.60 euros per month: 88% direct medical costs, 5% non-medical direct costs, and 7% indirect costs due to lost productivity. A better score in EORTC QLQ-30 quality of life was associated with a reduction in overall costs. CONCLUSIONS: The study showed the results of the first real-life prospective study evaluating the cost of illness of BTP in cancer patients demonstrating that the presence of breakthrough pain in a cancer patient causes a very significant increase in healthcare costs. FUNDING: Kyowa Kirin Farmacéutica, S.L.U.

Factores que influyen sobre el tiempo hasta la necesidad de intervenir un paciente en la lista de espera para prótesis de rodilla / Factors related with the time to surgery in waiting-list patients for knee prostheses

Objetivo. En el año 2006 se inició en el Complejo Hospitalario de Jaén un nuevo modelo de consulta monográfica de artrosis de rodilla (CMAR), para ofrecer al paciente un tratamiento de calidad basado en las guías de práctica clínica. El objetivo de este estudio fue analizar el rendimiento de la unidad, en términos de prolongación del tiempo hasta la necesidad de cirugía protésica de rodilla. Pacientes y métodos. Se realizó el análisis de una cohorte retrospectiva de pacientes atendidos en la CMAR y que dispusieran de un conjunto mínimo de datos. Se realizaron un análisis de Kaplan-Meier para evaluar el tiempo hasta la derivación del paciente a cirugía y un análisis de regresión de Cox para estudiar los factores relacionados con el tiempo hasta la derivación. Resultados. Participaron 224 pacientes con una edad media de 65,7 años (IC del 95%, 64 a 67), el 67,9% eran mujeres. El 48,2% tenía una afectación de grado 3 (Kellgren-Lawrence), un 27,5% de grado 2, un 15,3% de grado 4, y un 9% de grado 1. El 90,2% (202) recibió tratamiento con viscosuplementación (ácido hialurónico NASHA). La afectación de una sola articulación (p<0,0001; OR = 0,267, IC del 95%, 0,130 a 0,549), la mayor gravedad de la artrosis (p=0,048; OR = 0,410, IC del 95%, 0,169 a 0,992) y la menor intensidad del dolor (p<0,0001; OR = 1,091, IC del 95%, 1,044 a 1,141) fueron los factores relacionados con menor tiempo hasta la cirugía. El tratamiento con viscosuplementación aumentó el tiempo hasta la cirugía en todos los pacientes. Conclusiones. Factores como la menor edad del paciente y la afectación de una sola articulación influyeron en la decisión de derivación del paciente para cirugía. La administración de viscosuplementación prolongó el tiempo hasta que el paciente fue finalmente derivado a cirugía(AU)

Objective: In the year 2006 the Hospital Complex of Jaén began a new model of attention for consultation of knee osteoarthritis (CMAR), to offer quality treatment to the patient based on clinical practice guidelines. The objective of this study was to analyse the efficiency of the unit, in terms of delaying the time until a knee prostheses is needed. Patients and methods: An analysis of a retrospective cohort of patients seen at the CMAR was made, with a minimum available data set, and a Kaplan Meier analysis carried out in order to evaluate the time until the referral of the patient to surgery, as well as a Cox regression analysis in order to study the factors related with the time until the referral. Results: 224 patients were included, with mean age of 65.7 years (95% CI 64 to 67), 67.9% women. 48.2% had a stage III affection (Kellgren-Lawrence), 27.5% stage 2, 15.3% stage 4, and 9% stage 1. 90.2% (202) received treatment with viscosupplementation (Hialuronic acid NASHA). Single joint affection (P<.0001; OR 0,267, 95% CI 0.130 to 0,549), a higher degree of osteoarthritis (P=.048; OR 0,410, 95% CI 0.169 to 0,992), and lower intensity of pain (P<.0001; OR 1,091, 95% CI 1.044 to 1,141), were the factors related with shorter time until surgery. Treatment with viscosupplementation increased the time until surgery in all patients. Conclusions: Factors like a lower age of the patient and the involvement of a single joint influenced the referral of the patient to surgery. The administration of viscosupplementation, delayed the time until the patient was finally referred to surger(AU)

Factors related with the time to surgery in waiting-list patients for knee prostheses.

OBJECTIVE: In the year 2006 the Hospital Complex of Jaén began a new model of attention for consultation of knee osteoarthritis (CMAR), to offer quality treatment to the patient based on clinical practice guidelines. The objective of this study was to analyse the efficiency of the unit, in terms of delaying the time until a knee prostheses is needed. PATIENTS AND METHODS: An analysis of a retrospective cohort of patients seen at the CMAR was made, with a minimum available data set, and a Kaplan Meier analysis carried out in order to evaluate the time until the referral of the patient to surgery, as well as a Cox regression analysis in order to study the factors related with the time until the referral. RESULTS: 224 patients were included, with mean age of 65.7 years (95% CI 64 to 67), 67.9% women. 48.2% had a stage III affection (Kellgren-Lawrence), 27.5% stage 2, 15.3% stage 4, and 9% stage 1. 90.2% (202) received treatment with viscosupplementation (Hialuronic acid NASHA). Single joint affection (P<.0001; OR 0,267, 95% CI 0.130 to 0,549), a higher degree of osteoarthritis (P=.048; OR 0,410, 95% CI 0.169 to 0,992), and lower intensity of pain (P<.0001; OR 1,091, 95% CI 1.044 to 1,141), were the factors related with shorter time until surgery. Treatment with viscosupplementation increased the time until surgery in all patients. CONCLUSIONS: Factors like a lower age of the patient and the involvement of a single joint influenced the referral of the patient to surgery. The administration of viscosupplementation, delayed the time until the patient was finally referred to surgery.