Quality of life of menopausal women in the island of Majorca: a population based study.

OBJECTIVES: To explore demographic and epidemiological characteristics surrounding menopause among women of Majorca, estimate their health related quality of life (QOL), and ascertain wheather they differ from those of the mainland population of menopausal women. METHODS: A cross-sectional population-based study was conducted with a sample of 428 women. The Cervantes questionnaire for measuring QOL during menopause was used. RESULTS: Among women in Majorca, the mean QOL is better than the national mean of the Spain reference population. It declines with age and levels off at menopause. In menopausal women, QOL improves slightly in tandem with educational level. 29% of menopausal women were on some form of therapy, most commonly a mix of estrogens and gestagens (36%). Only a weak association was detected between being menopausal and QOL. CONCLUSION: The Cervantes questionnaire allows periodic study sample cut-offs to determine whether changes in sociodemographic and disease-related variables are also accompanied by changes in self-perceived QOL. It is much better in menopausal women in Majorca than in those in the Spanish mainland.

The use of risk sharing tools for post adoption surveillance of a non pharmacological technology in routine practice: results after one year.

BACKGROUND: To report results obtained by combining risk sharing tools with post-adoption surveillance mechanisms in order to control quality of care and implement a value-based reimbursement scheme for Neuro-reflexotherapy (NRT), a non-pharmacological treatment proven effective for neck pain (NP), thoracic pain (TP) and low back pain (LBP). METHODS: Pre-post prospective cohort study in routine clinical practice, carried out in primary care centers in the Spanish National Health Service in the Balearic Islands (Ib-Salut). Eight-hundred and seventy-one subacute and chronic NP, TP and LBP patients treated in Ib-Salut, who underwent NRT during 2011. A shared risk contract (SRC) was developed, where payments for NRT were linked to results on patients' clinical evolution, reduction in medication and proportion of patients undergoing spinal surgery. Main outcome measures were local pain (NP, TP or LBP), referred pain, LBP-related disability and NP-related disability, measured using previously validated instruments at referral and 3 months later, use of medication assessed at referral and discharge, and rates of spinal surgery prescription after undergoing NRT. RESULTS: Median improvements at discharge corresponded to 57.1% of baseline value for local pain, 75.0% for referred pain, 53.8% for LBP-related disability and 45.0% for NP-related disability. Patients taking medication at discharge represented 29.0% of those taking it at referral. The proportion of patients in whom spinal surgery was prescribed after undergoing NRT was 0%. These results were consistent with those from previous randomised controlled trials (RCTs) and studies in routine practice, and complied with the standards set in the SRC. CONCLUSIONS: It is feasible and effective to enhance post adoption surveillance methods with risk sharing tools to improve quality control and support value-based reimbursement decisions for NRT. The feasibility of generalising this approach to other settings and to other non-pharmacological treatments should be explored.

Association between antibiotic resistance in intensive care unit (ICU)-acquired infections and excess resource utilization: Evidence from Spain, Italy, and Portugal.

BACKGROUND: Intensive care unit (ICU)-acquired infections with antibiotic-resistant bacteria have been associated with substantial health and economic costs. Moreover, southern Europe has historically reported high levels of antimicrobial resistance. OBJECTIVES: We estimated the attributable economic burden of ICU-acquired infections due to resistant bacteria based upon hospital excess length of stay (LOS) in a selected sample of southern European countries. METHODS: We studied a cohort of adult patients admitted to the ICU who developed an ICU-acquired infection related to an invasive procedure in a sample of Spanish, Italian, and Portuguese hospitals between 2008 and 2016, using data from The European Surveillance System (TESSy) released by the European Centers for Disease Control (ECDC). We analyzed the association between infections with selected antibiotic-resistant bacteria of public health importance and excess LOS using regression, matching, and time-to-event methods. We controlled for several confounding factors as well as time-dependent biases. We also computed the associated economic burden of excess resource utilization for each selected country. RESULTS: In total, 13,441 patients with at least 1 ICU-acquired infection were included in the analysis: 4,106 patients (30.5%) were infected with antimicrobial-resistant bacteria, whereas 9,335 patients (69.5%) were infected with susceptible bacteria. The unadjusted association between resistance status and excess LOS was 7 days (95% CI, 6.13-7.87; P < .001). Fully adjusted models yielded significantly lower estimates: 2.76 days (95% CI, 1.98-3.54; P < .001) in the regression model, 2.60 days (95% CI, 1.66-3.55; P < .001) in the genetic matching model, and a hazard ratio of 1.15 (95% CI, 1.11-1.19; P < .001) in the adjusted Cox regression model. These estimates, alongside the prevalence of resistance, translated into direct hospitalization attributable costs per ICU-acquired infection of 5,224€ (95% CI, 3,691-6,757) for Spain, 4,461€ (95% CI, 1,948-6,974) for Portugal, and 4,320€ (95% CI, 1,662-6,977) for Italy. CONCLUSIONS: ICU-acquired infections associated with antibiotic-resistant bacteria are substantially associated with a 15% increase in excess LOS and resource utilization in 3 southern European countries. However, failure to appropriately control for significant confounders inflates estimates by ∼2.5-fold.

Caesarean section trends in Catalonia between 2013 and 2017 based on the Robson classification system: A cross-sectional study.

INTRODUCTION: In Catalonia caesarean rates have always been analysed as a single percentage. The objective is to estimate caesarean section rates using the Robson classification in publicly funded hospitals in Catalonia between 2013 and 2017, considering sociodemographic, institutional and obstetric characteristics. MATERIALS AND METHODS: Cross-sectional population-based study in Catalonia including all women delivering within publicly funded hospitals between 2013-2017 (n = 210 020). The modified Robson classification distribution was estimated, the caesarean rate and the overall contribution, analysed for each year, and by confounders, through logistic regression models. RESULTS: CS rates decreased steadily between 2013 and 2017 in Catalonia within publicly funded hospitals from 24.3% to 22.8% (cOR 0.92, 95% CI; 0.89 to 0.95). Once adjusted for changes in sociodemographic, institutional and obstetric characteristics the observed decline was even more pronounced (aOR 0.87, 95% CI; 0.84 to 0.90). Within the different groups of Robson once adjusted for confounders, groups 1+2 (aOR 0.88, 95% CI; 0.83 to 0.93), 3+4 (aOR 0.83, 95% CI; 0.78 to 0.89) and 10 (aOR 0.78, 95% CI; 0.68 to 0.90) presented a reduction in caesarean section rates, whereas group 5 showed no significant decrease (aOR 0.95, 95% CI; 0.87 to 1.03%). CONCLUSIONS: The decrease in caesarean section rates in Catalonia is more pronounced when adjusted for known confounders, suggesting retrospective overutilization of caesarean section and percentages of (in)adequacy in the past. In any case, it remains above the recommended by experts. Further efforts should be made to achieve optimum rates, including improvement on obstetric data collection.

Price Models for Multi-indication Drugs: A Systematic Review.

BACKGROUND: Marketing of new and existing drugs with new indications used alone or in combination is increasing. OBJECTIVE: To identify the advantages and disadvantages of indication-based pricing (IBP) systems for such drugs from the standpoint of economic theory, practical applications and international experiences. METHODS: We conducted a systematic review of published articles and reports using six bibliographic databases: PubMed, ASCO, Scopus, DARE, HTA and NHS EED. We also conducted a search of gray literature in Google Scholar. The same search terms were used as in Towse et al. (The debate on indication-based pricing in the U.S. and five major European countries. OHE Consulting Report, London, 2018). Articles and reports published from 1 January 2000 to 30 September 2018 were included. RESULTS: A total of 26 studies met the inclusion criteria. There are three main types of IBP: different brands with different prices for each indication, an averaged single price for all indications and a single price with differential discounts. The studies indicate that IBP systems are premised on the idea that charging a different price for different indications reflects the differences in their value and in social willingness to pay for each one and for the investment in R&D based on the indication's incremental clinical benefit. Some argue that a uniform price reduces access and increases the price for lower-value indications, while others contend that if IBP sets prices at the maximum threshold of social willingness to pay for each indication, all surplus is transferred to the producer and consumer surplus is reduced to zero. No practical applications of pure IBP were found. Single pricing for drugs is the most prevalent approach. The system that most closely approximates an IBP model consists of agreements that are generally confidential and linked to risk-sharing agreements. CONCLUSIONS: There are no applications of pure IBP systems and their practical consequences are therefore unknown. More economic theory-based assessments of the pros and cons of IBP and studies different from reviews are needed to capture their intricacies and specificities.

Impact of multi-drug resistant bacteria on economic and clinical outcomes of healthcare-associated infections in adults: Systematic review and meta-analysis.

BACKGROUND: Infections with multidrug resistant (MDR) bacteria in hospital settings have substantial implications in terms of clinical and economic outcomes. However, due to clinical and methodological heterogeneity, estimates about the attributable economic and clinical effects of healthcare-associated infections (HAI) due to MDR microorganisms (MDR HAI) remain unclear. The objective was to review and synthesize the evidence on the impact of MDR HAI in adults on hospital costs, length of stay, and mortality at discharge. METHODS AND FINDINGS: Literature searches were conducted in PubMed/MEDLINE, and Google Scholar databases to select studies that evaluated the impact of MDR HAI on economic and clinical outcomes. Eligible studies were conducted in adults, in order to ensure homogeneity of populations, used propensity score matched cohorts or included explicit confounding control, and had confirmed antibiotic susceptibility testing. Risk of bias was evaluated, and effects were measured with ratios of means (ROM) for cost and length of stay, and risk ratios (RR) for mortality. A systematic search was performed on 14th March 2019, re-run on the 10th of June 2019 and extended the 3rd of September 2019. Small effect sizes were assessed by examination of funnel plots. Sixteen articles (6,122 patients with MDR HAI and 8,326 patients with non-MDR HAI) were included in the systematic review of which 12 articles assessed cost, 19 articles length of stay, and 14 mortality. Compared to susceptible infections, MDR HAI were associated with increased cost (ROM 1.33, 95%CI [1.15; 1.54]), prolonged length of stay (ROM 1.27, 95%CI [1.18; 1.37]), and excess in-hospital mortality (RR 1.61, 95%CI [1.36; 1.90]) in the random effects models. Risk of publication bias was only found to be significant for mortality, and overall study quality good. CONCLUSIONS: MDR HAI appears to be strongly associated with increases in direct cost, prolonged length of stay and increased mortality. However, further comprehensive studies in this setting are warranted. TRIAL REGISTRATION: PROSPERO (CRD42019126288).

[What is an efficient health intervention in Spain in 2020?] / ¿Qué es una intervención sanitaria eficiente en España en 2020?

Fifteen years ago, Gaceta Sanitaria published the article entitled "What is an efficient health technology in Spain?" The growing interest in setting the price of new technologies based on the value they provide to health systems and the experience accumulated by the countries in our environment make it opportune to review what constitutes an efficient health intervention in Spain in 2020. Cost-effectiveness analysis continues to be the reference method to maximize social health outcomes with the available resources. The interpretation of its results requires establishing reference values that serve as a guide on what constitutes a reasonable value for the health care system. Efficiency thresholds must be flexible and dynamic, and they need to be updated periodically. Its application should be based on and transparency, and consider other factors that reflect social preferences. Although setting thresholds is down to political decision-makers, in Spain it could be reasonable to use thresholds of 25,000 and 60,000 Euros per QALY. However, currently, in addition to determining exact figures for the threshold, the key question is whether the Spanish National Health System is able and willing to implement a payment model based on value, towards achieving gradual financing decisions and, above all, to improve the predictability, consistency and transparency of the process.

[Integration of information for health interventions: from data to information and from information to action. 2008 SESPAS Report]. / Integración de la información para las intervenciones sanitarias: de los datos a la información; de la información a la acción. Informe SESPAS 2008.

Spanish public health and health services information systems (HIS) have improved, but are still fragmented by areas of interest and have evolved independently from one another. Their format, structure, integrity and data quality vary widely, as do the programs, platforms and databases that support them. The latest innovations focus on isolated HIS and are hampered by obsolete models, tools, functionalities, and the inertial demand of information. Transfer of responsibilities without minimal agreements on HIS has eroded their national cohesion and, along with the absence of exchanges on experiences of computerization on a national basis, has weakened us, given the supply of immature computer applications. The evolution of HIS must be governed by integration. We have to redefine their strategic and operational objectives, review existing data and information, and determine the single identification of specific persons and patients. Variables, indicators, services and control panels should be reviewed and systematized through a single shared nomenclature. Personal health records and administrative and clinical registries should become the primary sources of health information data. Data collection, mechanization, registration and exploitation, and their quality control and maintenance, should be redefined regardless of setting. A national agreement is urgently required on the minimal functionalities of HIS, while respecting their technical nature and management by autonomous governments.

Predictive modeling of emergency cesarean delivery.

OBJECTIVE: To increase discriminatory accuracy (DA) for emergency cesarean sections (ECSs). STUDY DESIGN: We prospectively collected data on and studied all 6,157 births occurring in 2014 at four public hospitals located in three different autonomous communities of Spain. To identify risk factors (RFs) for ECS, we used likelihood ratios and logistic regression, fitted a classification tree (CTREE), and analyzed a random forest model (RFM). We used the areas under the receiver-operating-characteristic (ROC) curves (AUCs) to assess their DA. RESULTS: The magnitude of the LR+ for all putative individual RFs and ORs in the logistic regression models was low to moderate. Except for parity, all putative RFs were positively associated with ECS, including hospital fixed-effects and night-shift delivery. The DA of all logistic models ranged from 0.74 to 0.81. The most relevant RFs (pH, induction, and previous C-section) in the CTREEs showed the highest ORs in the logistic models. The DA of the RFM and its most relevant interaction terms was even higher (AUC = 0.94; 95% CI: 0.93-0.95). CONCLUSION: Putative fetal, maternal, and contextual RFs alone fail to achieve reasonable DA for ECS. It is the combination of these RFs and the interactions between them at each hospital that make it possible to improve the DA for the type of delivery and tailor interventions through prediction to improve the appropriateness of ECS indications.

It's about time: Cesarean sections and neonatal health.

Cesarean sections have been associated in the literature with poorer newborn health, particularly with a higher incidence of respiratory morbidity. Most studies suffer, however, from potential omitted variable bias, as they are based on simple comparisons of mothers who give birth vaginally and those who give birth by cesarean section. We try to overcome this limitation and provide credible causal evidence by using variation in the probability of having a c-section that is arguably unrelated to maternal and fetal characteristics: variation by time of day. Previous literature documents that, while nature distributes births and associated problems uniformly, time-dependent variables related to physicians' demand for leisure are significant predictors of unplanned c-sections. Using a sample of public hospitals in Spain, we show that the rate of c-sections is higher during the early hours of the night compared to the rest of the day, while mothers giving birth at the different times are similar in observable characteristics. This exogenous variation provides us with a new instrument for type of birth: time of delivery. Our results suggest that non-medically indicated c-sections have a negative and significant impact on newborn health, as measured by Apgar scores, but that the effect is not severe enough to translate into more extreme outcomes.

The merry-go-round of approval, pricing and reimbursement of drugs against the Hepatitis C virus infection in Spain.

Given that drug innovation has been largely away from breakthroughs, arguing that a new drug recently approved and reaching the market is downright effective, safe and affordable is actually parlous. The soaring costs of an increasing number of new drugs (specially for cancer and rare diseases) threaten to supersede societal absorbing capacity, competing with other health and outside health sector resources. Some health systems are not making headways towards solving the current conundrum of keeping path with the state of the art regulatory mechanisms in delivering cost-effective, equitable and affordable treatments. The way pricing and reimbursement decisions have been made in Spain regarding the recent wave of new drugs against the hepatitis C virus could be one case in point. This paper analyses the path of decision-making and the positioning of the relevant actors in this case, that has set a cumbersome precedent (earmarked fund) for the Spanish National Health Service. It also stresses the need for current decision-making mechanisms on approval, pricing, coverage and reimbursement in Spain to move to a transparent regulatory system, avoiding improvisation and incorporating the highest regulatory standards that other countries have in place.

[Health services supply and the economic crisis: either we fund goods and services according to their value or we become bankrupt. SESPAS report 2014]. / Oferta sanitaria y crisis: financiamos los bienes y servicios según su valor o caemos en la insolvencia. Informe SESPAS 2014.

Health policy has reacted to the financial crisis by overemphasising measures targeted at reducing unit costs, increasing barriers to access (waiting lists) or closing premises. It is too soon for scientific assessment of the impact of this reshaping of supply on equity, quality and safety, and on individual and population health. Nevertheless, the emergency measures taken to achieve fiscal stabilization have shifted the focus to resolving budget problems at the expenses of sounder and deeper initiatives aimed at deciding what must be funded and how. This article advocates a policy based on selective funding of services and benefits on the basis of their value. Other countries' experiences can serve as a useful guide, including robust methods to identify technologies (or their uses) of questionable value, prioritization criteria, and careful consideration of limitations associated with the elimination of a certain benefit, especially if it affects the founding values of the system. The necessary tools are available to the Spanish health system: the regulatory framework and technical bodies able to identify lower value care, support for decision-making, and timely evaluation of such decisions. Despite the numerous hurdles, maintaining the status quo is too expensive a choice, given the opportunity costs of effectiveness and safety losses, measured in terms of equity and the economic efficiency of the Spanish health system, which may ultimately translate into worsening of the population's health status.

A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe.

The unacceptably high incidence of clinical adverse events caused by medical devices (MDs), their high recall rates, and the frequent phase out of some of the devices that pose a greater risk to health have triggered alarm concerning the long-standing weaknesses of their regulatory processes. It has long been known that regulation is not strongly associated with the existence of market failures. In this article the deficient approval process and postmarketing surveillance of MDs in the United States and Europe, as well as the causes and effects of their very serious failings, that put patient safety at serious risk, are critically reviewed. Solutions to address the urgent need to develop new regulation in the European Union are set forth as well. The fragmented MD industry is plagued with externalities. It seems that regulation is more being supplied in response to industry's demand (legislation and agencies capture) than for redistributing health and wealth. Severe adverse events associated with MD are spurring demand for regulation. Governments should promote the most risked-based, cost-effective regulations, those that pursue the interests of individuals affected, by using public and unbiased estimates of their costs and benefits, maximizing net health gains through legislation, applying clear rules of the game, and braking up the effects of the influence of interest groups.