Improved short-term outcomes of kidney transplants in controlled donation after the circulatory determination of death with the use of normothermic regional perfusion.

Normothermic regional perfusion (NRP) allows the in situ perfusion of organs with oxygenated blood in donation after the circulatory determination of death (DCDD). We aimed at evaluating the impact of NRP on the short-term outcomes of kidney transplants in controlled DCDD (cDCDD). This is a multicenter, nationwide, retrospective study comparing cDCDD kidneys obtained with NRP versus the standard rapid recovery (RR) technique. During 2012-2018, 2302 cDCDD adult kidney transplants were performed in Spain using NRP (n = 865) or RR (n = 1437). The study groups differed in donor and recipient age, warm, and cold ischemic time and use of ex situ machine perfusion. Transplants in the NRP group were more frequently performed in high-volume centers (≥90 transplants/year). Through matching by propensity score, two cohorts with a total of 770 patients were obtained. After the matching, no statistically significant differences were observed between the groups in terms of primary nonfunction (p = .261) and mortality at 1 year (p =  .111). However, the RR of kidneys was associated with a significantly increased odds of delayed graft function (OR 1.97 [95% CI 1.43-2.72]; p < .001) and 1-year graft loss (OR 1.77 [95% CI 1.01-3.17]; p = .034). In conclusion, compared with RR, NRP appears to improve the short-term outcomes of cDCDD kidney transplants.

Residence, Clinical Features, and Genetic Risk Factors Associated with Symptoms of COVID-19 in a Cohort of Older People in Madrid.

BACKGROUND: The older population has been especially affected by the severe acute respiratory syndrome coronavirus 2 pandemic (COVID-19). OBJECTIVE: The aim of the study was to explore the incidence, severity, mortality rate, clinical features, and risk factors of symptoms of COVID-19 in home-dwelling older people, and its association with type of residence, cognitive deterioration, and neurodegenerative diseases. METHODS: Data about symptoms of COVID-19 were collected through a telephone survey in the cohort of 913 older volunteers of the Vallecas Project, aged 75-90 years, most of them (902) home-dwelling, in Madrid, Spain. The association of demographic and anthropometric measures, genetic polymorphisms, comorbidities, life habits, type of residence, and frailty surrogates were explored as potential risk factors for the incidence, severity, and mortality of COVID-19 in the older population. FINDINGS: Sixty-two cases reported symptoms compatible with COVID-19; 6 of them had died, 4 in their home and 2 in the nursing home. Moderate/severe cases were significantly older and more frequently males. The APOE ε4 allele was associated with the presence of symptoms of COVID-19. Higher systolic blood pressure, more intense smoking habit, more alcohol intake, lower consumption of coffee and tea, and cognitive impairment were associated with disease severity. CONCLUSIONS: The estimated incidence of symptomatic COVID-19 in this older cohort of Madrid was 6.8%, with an overall mortality rate of 0.7% (18.2% in those living in a nursing home) and a fatality rate of 9.9%. Our exploratory study indicates that life habits, other clinical conditions and, the ε4 variant of the APOE gene are associated with the presence and clinical severity of coronavirus infection.

Social engagement within the facility increased life expectancy in nursing home residents: a follow-up study.

BACKGROUND: Social engagement (SE) has been consistently shown to improve survival among community-dwelling older people, but the evidence in nursing home residents is inconclusive and prone to short-term reverse causation and confounding by major health determinants. Our main objective was to study the potential causal effect of within-the-facility social engagement (SE) on long-term all-cause mortality in care home residents. METHODS: A representative cohort of 382 nursing home residents in Madrid without severe physical and cognitive impairments at baseline was followed up for 10-year all-cause mortality. Standardized mortality curves for residents with low/null, moderate, and high levels of SE at baseline were estimated using Kaplan-Meier methods and spline-based survival models with inverse probability of exposure weights conditional on baseline sociodemographic characteristics, facility features, comorbidity, and disability. Standardized 5-year mortality risks and median survival times were compared across levels of SE. RESULTS: The baseline prevalences of low/null, moderate, and high SE were 36, 44, and 20%, respectively. Compared with residents with low/null SE at baseline, the standardized differences (95% confidence intervals) in 5-year mortality risk were - 2.3% (- 14.6 to 10.0%) for moderately engaged residents and - 18.4% (- 33.8 to - 2.9%) for highly engaged residents. The median survival time increased by 0.4 (- 1.4 to 2.2) and 3.0 (0.8 to 5.2) years, respectively. CONCLUSION: Residents with high SE within the nursing home had an 18% lower 5-year mortality risk and a 3-year increase in their median survival, as compared with residents with similar health determinants but low/null SE. The development of adequate tailored intervention programs, addressed to increase SE in nursing home residents, could improve their long-term survival, in addition to expected gains in quality of life.

[Clinical empathy among family and community medicine residents and tutors. The view of physicians and patients]. / Empatía médica en residentes y tutores de medicina familiar y comunitaria. La visión del profesional y del paciente.

AIM: To determine the degree of clinical empathy among family medicine residents and tutors. To gauge whether there is a relationship between physicians' self-perceived empathy levels and their patients' assessments. STUDY DESIGN: Observational, cross-sectional survey. LOCATION: Primary Care Teaching Unit. Madrid. PARTICIPANTS: A survey was sent by email to all the Teaching Unit's family medicine tutors and residents. Responses were received from 50 residents (39.4%) and 41 tutors (45%). In addition, 428 patients were opportunistically recruited at a healthcare centre and their doctors were also interviewed. PRIMARY MEASUREMENT INSTRUMENTS: Empathy was measured using the Jefferson Scale of Empathy and the Jefferson Scale of Patient Perceptions of Physician Empathy. RESULTS: The tutors scored 2.53 points higher for cognitive empathy than the residents (P=.04). Emotional empathy scores declined among older tutors (r= -0.32; P=.05). The Spanish students (82% of the total) without previous work experience scored higher for overall empathy (P=.02). Final-year residents recorded significantly worse empathy assessments than the other residents. A positive correlation (r=0.72; P=.01) was observed between physicians' self-perceived empathy and their patients' perceptions. CONCLUSIONS: Residents with previous work experience, final-year residents and those of Latin American origin score lower for empathy. There is a strong relationship between physicians' self-perceived empathy and their patients' views of their empathy levels.

Urinary incontinence and mortality among older adults residing in care homes.

AIM: To assess the association between baseline urinary incontinence and long-term, all-cause mortality. BACKGROUND: Urinary incontinence is a common disorder among older institutionalised adults, with important consequences for morbidity and quality of life. Moreover, while it is a consistent mortality marker, the extent to which this association might be causal remains controversial. DESIGN: A cohort study. METHODS: We conducted a mortality follow-up study on a cohort of 675 nursing-home residents in the city of Madrid (Spain), from their 1998-1999 baseline interviews to September 2013. Study subjects or their caregivers were asked whether the resident had experienced any involuntary leakage of urine in the preceding 14 days, with subjects being subsequently defined as continent, mildly incontinent, or severely incontinent. Hazard ratios for all-cause mortality were estimated using Cox proportional hazards models. RESULTS: After a 4061 person-year follow-up (median/maximum of 4·6/15·2 years), 576 participants had died. In fully-adjusted models, urinary incontinence was associated with a 24 per cent increased risk of all-cause mortality. There was a graded relationship across severity levels, with hazard ratios 7% higher for mild and 44% higher for severe incontinence as compared with the continent group. The adjusted mortality fraction attributable to urinary incontinence was 11 per cent. CONCLUSION: It would appear that urinary incontinence is not only a marker but also a real determinant of survival in the institutionalized population. This finding, which seems plausible in a population of frail older adults, warrants further research into mechanisms that could help to elucidate this hypothesis.

Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database.

BACKGROUND: Studies have shown a slight excess risk in Guillain-Barré syndrome (GBS) incidence associated with A(H1N1)pdm09 vaccination campaign and seasonal trivalent influenza vaccine immunisations in 2009-2010. We aimed to assess the incidence of GBS as a potential adverse effect of A(H1N1)pdm09 vaccination. METHODS: A neurologist-led network, active at the neurology departments of ten general hospitals serving an adult population of 4.68 million, conducted GBS surveillance in Spain in 2009-2011. The network, established in 1996, carried out a retrospective and a prospective study to estimate monthly alarm thresholds in GBS incidence and tested them in 1998-1999 in a pilot study. Such incidence thresholds additionally to observation of GBS cases with immunisation antecedent in the 42 days prior to clinical onset were taken as alarm signals for 2009-2011, since November 2009 onwards. For purpose of surveillance, in 2009 we updated both the available centres and the populations served by the network. We also did a retrospective countrywide review of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis from January 2009 to December 2011. RESULTS: Among 141 confirmed of 148 notified cases of GBS or Miller-Fisher syndrome, Brighton 1-2 criteria in 96 %, not a single patient was identified with clinical onset during the 42-day time interval following A(H1N1)pdm09 vaccination. In contrast, seven cases were seen during a similar period after seasonal campaigns. Monthly incidence figures did not, however, exceed the upper 95 % CI limit of expected incidence. A retrospective countrywide review of the registry of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis did not suggest higher admission rates in critical months across the period December 2009-February 2010. CONCLUSIONS: Despite limited power and underlying reporting bias in 2010-2011, an increase in GBS incidence over background GBS, associated with A(H1N1)pdm09 monovalent or trivalent influenza immunisations, appears unlikely.

Ethical considerations surrounding the response to Ebola: the Spanish experience.

BACKGROUND: The recent Ebola virus disease (EVD) outbreak, with 28,646 reported cases and 11,323 deaths, was declared a public health emergency of international interest by the World Health Organisation. In Spain, a single reported case triggered a public health crisis of a markedly media-centred nature. The approach to the first EVD epidemic has given rise to various ethical considerations around the world. We address the most relevant ethical considerations emanating from the management of EVD in Spain. MAIN BODY: Firstly, for reasons of global justice and humanitarian assistance, rich countries have the duty to support poorer countries in building up their core public-health capacities. Secondly, quarantine for high-risk contacts might have been a disproportionate and not properly justified measure, which could have contributed to stigmatising contacts and spreading panic. Thirdly, when the first secondary case was reported in Spain, it is doubtful whether informed consent requirements were strictly complied with when disclosing information concerning the alleged accident potentially causing the contagion. Moreover, this information was used by the Regional Health Minister to blame the patient, evading his responsibility to ensure safe medical procedures for health workers. Finally, the patient received convalescent plasma for compassionate use from a colleague of the first missionary repatriated, who also participated in a research study in Spain, despite having previously been denied the chance of being transferred to Spain to receive treatment. This fact highlights the asymmetry in the relationship between rich and poor countries. SHORT CONCLUSION: The management of this crisis highlighted the technical capacity of the health system and its professionals to respond effectively to public health emergencies caused by emerging diseases. This said, the failures in the protection of the EVD patient's privacy remind us that this aspect has to be borne in mind from the outset in crisis situations. Certain coercive measures, such as quarantine, should only be applied where there is some evidence that the benefit-risk balance could be favourable. Lastly, it is essential that research and interventions targeted at combating the fragility of the health systems in poor countries respond to reasons of global justice.

Incidence of multiple sclerosis in Northern Lisbon, Portugal: 1998-2007.

BACKGROUND: There are few, recent, well assessed, multiple sclerosis (MS) incidence surveys on European populations. This study sought to measure MS incidence in a Northern Lisbon population and assess it using capture-recapture methods (CRMs). METHODS: Among the population residing in the Northern Lisbon Health Area, registered MS diagnoses were obtained from general practitioners in three primary-care districts covering a population of 196,300, and a neurology unit at the main referral hospital. Cases with onset during the periods 1978-1997 and 2008-2012 were excluded due to perceived poor access to image-supported neurological diagnosis and administrative changes in patient referral respectively. Age- and sex-specific incidences for the period 1998-2007 were calculated using McDonald diagnostic criteria, and CRMs were used to correct age-specific incidence rates. The corrected figures were also adjusted for age using the European Standard Population as reference. RESULTS: When applied to 62 MS patients with onset in the period 1998-2007, the rates per 100,000 population were as follows for both sexes: crude, 3.16; age-adjusted, 3.09 (95% CI 2.32 to 3.87); CRM-adjusted, 4.53 (95% CI 3.13 to 5.94); and age- and CRM-adjusted, 4.48 (3.54-5.41). In general, the rates were 3-fold higher among women than among men. Negative source dependency and CRM impact were highest at ages 35-44 years, where a 60% rise led to a peak incidence. CONCLUSIONS: MS incidence in Northern Lisbon, Portugal, is moderately lower than that yielded by surveys on European populations. CRMs, which in this instance suggest undercounts, are a potentially useful tool for case-finding assessment but their application may introduce bias.

Restrictions on Hospital Referrals from Long-Term Care Homes in Madrid and COVID-19 Mortality from March to June 2020: A Systematic Review of Studies Conducted in Spain.

In March 2020, a ministerial directive issued by the Government of the Community of Madrid (CoM) in Spain included disability-based exclusion criteria and recommendations against hospital referral of patients with respiratory conditions living in long-term care homes (LTCHs). Our objective was to assess whether the hospitalization mortality ratio (HMR) is greater than unity, as would be expected had the more severe COVID-19 cases been hospitalized. Thirteen research publications were identified in this systematic review of mortality by place of death of COVID-19-diagnosed LTCH residents in Spain. In the two CoM studies, the HMRs were 0.9 (95%CI 0.8;1.1) and 0.7 (95%CI 0.5;0.9), respectively. Outside of the CoM, in 9 out of 11 studies, the reported HMRs were between 1.7 and 5, with lower 95% CI limits over one. Evaluation of the disability-based triage of LTCH residents during March-April 2020 in public hospitals in the CoM should be conducted.

Public and Patients' Perspectives Towards Data and Sample Sharing for Research: An Overview of Empirical Findings.

We aimed to review the attitudes and perspectives of the public and patients towards the sharing of data and biospecimens for research and to identify common dimensions, regardless of setting. Our review included systematic, scoping or thematic reviews of empirical studies retrieved from Medline (PubMed interface), Web of Science, Scopus, ProQuest and Cochrane Reviews. The main themes identified and synthesised across the 14 reviews were readiness and motivations; potential risks and safeguards; trust, transparency and accountability; autonomy and preferred type of consent; and factors influencing data and biospecimen sharing and consent. Sociodemographic factors and research and individual context remain relevant influencing factors in all settings, while preferences for types of consent are highly heterogeneous. Trusted environments and adapted consent options with participant engagement are relevant to improve research participation.

The Impact of Long-Term Care Home Ownership and Administration Type on All-Cause Mortality from March to April 2020 in Madrid, Spain.

Our aim is to assess whether long-term care home (LTCH) ownership and administration type were associated with all-cause mortality in 470 LTCHs in the Community of Madrid (Spain) during March and April 2020, the first two months of the COVID-19 pandemic. There are eight categories of LTCH type, including various combinations of ownership type (for-profit, nonprofit, and public) and administration type (completely private, private with places rented by the public sector, administrative management by procurement, and completely public). Multilevel regression was used to examine the association between mortality and LTCH type, adjusting for LTCH size, the spread of the COVID-19 infection, and the referral hospital. There were 9468 deaths, a mortality rate of 18.3%. Public and private LTCHs had lower mortality than LTCHs under public-private partnership (PPP) agreements. In the fully adjusted model, mortality was 7.4% (95% CI, 3.1-11.7%) in totally public LTCHs compared with 21.9% (95% CI, 17.4-26.4%) in LTCHs which were publicly owned with administrative management by procurement. These results are a testimony to the fatal consequences that pre-pandemic public-private partnerships in long-term residential care led to during the first months of the COVID-19 pandemic in the Community of Madrid, Spain.

[Unknown mortality of the population in long-term care homes in Spain]. / La desconocida mortalidad de la población en las residencias de personas mayores de España.

It seems necessary to assess the mortality of older people living in long-term care homes to examine its determinants, including the structural and organizational characteristics of these centers and their relationship with the use of health and social services. Attempting to investigate the mortality of the population over 65 years of age living in long-term care homes during COVID-19, we were not able to identify those who died at their long-term care home and, consequently, to know their number of deaths and their causes. In this field note, we describe this anomalous situation and propose a solution: compliance with the law that obliges all citizens to register at their usual address, which should be required in the process of admission to a residence. This would ensure the availability of the necessary data to know the mortality of the population residing in a residence.

Melamine toxicity: one more culprit in calcium kidney lithiasis.

An outbreak of uric acid and melamine kidney stones and obstructive acute renal failure in children appeared recently in China due to the ingestion of melamine-tainted formula. Liu and colleagues show that calcium urolithiasis is also strongly associated with urine melamine in adults in Taiwan. Although its effect measure is still uncertain, such an association is likely to be causal. These findings prompt further research into the source of exposure, impact in other settings, and changes over time.

Impact of early oseltamivir treatment on outcome in critically ill patients with 2009 pandemic influenza A.

OBJECTIVES: The impact of oseltamivir on mortality in critically ill patients with 2009 pandemic influenza A (2009 H1N1) is not clear. The main objective of this study was to investigate the relationship between the timing of antiviral administration and intensive care unit (ICU) outcomes. METHODS: Prospective, observational study of a cohort of ICU patients with confirmed 2009 H1N1 infection. Clinical data, treatment and outcome were compared between patients receiving early treatment (ET) with oseltamivir, initiated within 2 days, and patients administered late treatment (LT), initiated after this timepoint. Multivariate analysis and propensity score were used to determine the effect of oseltamivir on ICU mortality. RESULTS: Six hundred and fifty-seven patients were enrolled. Four hundred and four (61.5%) patients required mechanical ventilation (MV; mortality 32.6%). Among them, 385 received effective antiviral therapy and were included in the study group. All patients received oseltamivir for a median duration of 10 days (interquartile range 8-14 days). Seventy-nine (20.5%) ET patients were compared with 306 LT patients. The two groups were comparable in terms of main clinical variables. ICU length of stay (22.7 ±â€Š16.7 versus 18.4 ±â€Š14.2 days; P = 0.03), hospital length of stay (34.0 ±â€Š20.3 versus 27.2 ±â€Š18.2 days; P = 0.001) and MV days (17.4 ±â€Š15.2 versus 14.0 ±â€Š12.4; P = 0.04) were higher in the LT group. ICU mortality was also higher in LT (34.3%) than in ET (21.5%; OR = 1.9; 95% CI 1.06-3.41). A multivariate model identified ET (OR = 0.44; 95% CI 0.21-0.87) as an independent variable associated with reduced ICU mortality. These results were confirmed by propensity score analysis (OR = 0.44; 95% CI 0.22-0.90; P < 0.001). CONCLUSIONS: Our findings suggest that early oseltamivir administration was associated with favourable outcomes among critically ill ventilated patients with 2009 H1N1 virus infection.

Face masks in the general healthy population. Scientific and ethical issues.

In most European countries, facemasks use is recommended or mandatory in enclosed spaces where physical distancing is not possible. In Spain, this measure was first extended to open public spaces and later made mandatory regardless of whether or not the interpersonal safety distance can be kept. At present, there is no evidence on the effectiveness of universal masking of healthy people in the community to prevent infection with respiratory viruses, including SARS-CoV-2. The mandatory use of masks poses some ethical questions. Firstly, it entails a paternalistic action. Secondly, application of the principle of precaution becomes questionable when there is no clear benefit-risk relationship. Thirdly, compulsoriness can interfere with equity of public health actions. Fourthly, it can result in social stigma and discrimination against those who do not wear one, even though they well may have good reasons for doing so. Lastly, this measure may generate confusion in the population, along with an altered perception of the risk. The World Health Organization recommends its use in public places with a high potential risk of transmission and where other prevention measures, such as physical distancing, are not possible. Mandatory use of masks in public open spaces, regardless of the risk of transmission or of whether or not the interpersonal safety distance can be kept, is an intrusive measure that restricts individual freedoms, and would not appear to be justified on the basis of available scientific evidence. What we need are recommendations explaining where, when, how and what type of mask to wear.

Conflicts of interest among scientific foundations and societies in the field of childhood nutrition.

OBJECTIVE: To describe food-industry sponsorships of associations active in the field of childhood nutrition and obesity prevention in Spain in 2017-2018. METHOD: The associations were located at https://www.google.es/ using the words "society", "foundation" or "federation" in combination with the terms "nutrition", "obesity", "childhood", "paediatrics" and "diabetes". Sponsorship was defined as the declaration of funding received or the appearance of a food company logo on an association's website or in the programmes of its congresses or courses. The percentage of sponsored societies and its association with the existence of ethical codes was calculated using MS Excel. RESULTS: 64% of the associations displayed some type of sponsorship, with this being most frequent among paediatric and nutrition societies, 83% and 80% respectively, and non-existent among public health societies. No association was found between the existence of an ethical code and sponsorship (odds ratio: 0.75; 95% confidence interval: 0.14-3.94). The leading corporate sponsors were Nestlé, Coca-Cola and Danone. Whereas the initiatives of sponsored societies were targeted at changing eating individual behaviours, those of unsponsored societies sought to promote changes in the food system and eating environments. CONCLUSIONS: Food industry sponsorship of foundations and scientific societies is very widespread in Spain, except among public health associations. Unlike sponsored associations, those unsponsored propose policies opposed by the food industry, which are aimed at improving the system and food and eating environments.

Association of disability with mortality in the Spanish adult non-institutionalised population.

BACKGROUND: There are scant studies focused on measuring the association between disability and all-cause mortality based on large representative national samples of the community-dwelling adult population; moreover, the number of such studies which also include cause-specific mortality is yet lower. METHODS: Longitudinal cohort study that used baseline data from 162 381 adults who participated in a countrywide disability survey (2008). A nationally representative sample was selected and interviewed in their homes. We present data on people ≥18 years. Disability was considered as any substantial limitation found on a list of 44 life activities that have lasted or are expected to last more than 1 year and originate from an impairment. Cause-specific mortality data were obtained from the Spanish Statistical Office. Subjects contributed follow-up time from baseline interview until death or the censoring date (31 December 2017). We computed standardised rate ratios (SRRs), with age, sex, living with a partner and education level distribution of the total group as standard population. RESULTS: Adults with disability (11%) had an adjusted mortality rate more than twice as high as adults without disability (SRR 2.37, 95% CI 2.24 to 2.50). The increased mortality risk remained over the 10-year follow-up period. Mortality due to diseases of the nervous system (SRR 4.86, 95% CI 3.93 to 6.01), diseases of the musculoskeletal system (SRR 3.45, 95% CI 2.18 to 5.47), infectious diseases (SRR 3.38, 95% CI 2.27 to 5.01) and diabetes mellitus (SRR 3.56, 95% CI 2.71 to 4.68) was particularly high in those with disability. CONCLUSIONS: All-cause mortality rates are markedly higher among adults with disability. Preventive measures and health promotion initiatives are needed to reduce mortality risk in this population. Special attention should be paid to disabled people with certain specific diseases.

Survival Patterns of Human Prion Diseases in Spain, 1998-2018: Clinical Phenotypes and Etiological Clues.

BACKGROUND: Human transmissible spongiform encephalopathies (TSEs) are a group of fatal neurodegenerative disorders of short duration. There are few studies on TSE survival. This study sought to analyze the survival and related factors of a TSE patient cohort, based on a nationwide surveillance system in Spain. METHODS: Survival analyses were performed on 1,530 cases diagnosed across the period 1998-2018 in Spain. We calculated median survival times and plotted survival curves using the Kaplan-Meier method for all cases and for sporadic TSE (sTSE) and genetic TSE (gTSE). Crude and adjusted Cox proportional hazard models were used to identify variables associated with shorter survival. FINDINGS: Median age at onset decreased from the sporadic forms to gTSE and, lastly, to acquired TSE. Overall median and interquartile range (IQR) survival time was 5.2 (IQR, 3.0-11.7) months and 4.9 (IQR, 2.8-10.8) months in sporadic cases and 9 (IQR, 4.9 to over 12) months in genetic cases, p < 0.001. Male sex, older age at onset, presence of 14-3-3 protein, typical MRI, and MM and VV polymorphisms at codon 129 were associated with shorter survival. gTSE showed higher survival in crude comparisons but not after adjustment. INTERPRETATION: TSE survival in Spain replicates both the magnitude of that shown and the TSE entity-specific population patterns observed in Western countries but differs from features described in Asian populations, such as the Japanese. The reduction in differences in survival between gTSE and sTSE on adjusting for covariates and international patterns might support the view that gTSE and sTSE share causal and pathophysiological features.

[Half a century of newborn screening in Spain: Evolution of ethical, legal and social issues (ELSIs). Part III, social issues.] / Medio siglo de cribado neonatal en España: evolución de los aspectos éticos, legales y sociales (AELS). Parte III, aspectos sociales.

Decision making for the development of newborn screening programs is based on not only medical but also social concerns and involves different stakeholders. Part III of the article focuses on their role in the governance of the programs. First of all, we consider the proactive role that health authorities has played in the evolution to an evidentiary model of policy development currently based on evidence, just as in the preparation of an expert, impartial and transparent opinion on health policy and its coordination with the national health system. And, in accordance with this evidence and with the consensus, health autorities following quality criteria have made an attempt to achieve a more homogeneous approach of the neonatal screening program throughout the territory. Secondly, we address the role of several scientific and professional societies in newborn screening. Among them, it deserves to be mentioned the Spanish Society for Clinical Chemistry, currently Spanish Society of Laboratory Medicine (SEQCML), and its Commission of inborn errors of metabolism and the Spanish Society for Newborn Screening (AECNE), which since 1985 and for thirty three years collected the activity of newborn screening centers and established a forum for debate, sharing of knowledge and cooperation among screening centers and with health authorities. Since 1999, the Spanish Society for Inborn Errors of Metabolism (AECOM) exercises an important activity in the field of diagnosis treatment and follow up of patients. Finally, we consider the role of families and the psychosocial aspects of the programme, and the associative activity of patient organizations. In 1990 the Spanish federation of PKU and other disorders (FAEPKU) was found, renamed currently as The Spanish Federation of Inherited Metabolic Diseases; together with the Spanish Federation for Rare Diseases (FEDER), found in 1999, they both have clearly contributed to the patient's empowerment, supporting research and education and establishing a network of cooperation and support for patients and their families. Patient organizations collaborate with health authorities but they have not participated in policy decision making yet. During this half century, the evolution of newborn screening programs have been characterized for a spirit of improvement, by including the development of ethical, legal and social issues. Important technological challenges lie ahead and it will be necessary to know how to use them efficiently, proportionally and fairly in the best interest of newborns and by extension of their family and society.

Las bases para la toma de decisiones acerca del desarrollo de los programas de cribado de Salud Pública no son exclusivamente médicas, sino también sociales. En esta parte III del artículo se contemplan los actores que intervienen en la gobernanza de los programas, cómo son las autoridades sanitarias, las sociedades científicas y profesionales, así como las familias y su movimiento asociativo. En primer lugar, se analiza el papel de las instituciones/autoridades sanitarias en el desarrollo de los programas y en la evolución del modelo para la toma de decisiones, hasta el actual basado en la evidencia, así como en la elaboración de una opinión experta, imparcial y transparente en política sanitaria y su coordinación en el marco del Sistema Nacional de Salud (SNS). Y, de acuerdo con dicha evidencia y con el consenso, las instituciones/autoridades sanitarias han tratado de conseguir un abordaje más homogéneo y conforme a criterios de calidad del programa de cribado neonatal en todo el territorio. A continuación, se aborda el papel de las sociedades científicas y profesionales, especialmente de la Sociedad Española de Química Clínica (actualmente Sociedad Española de Medicina de Laboratorio (SEQCML), a través de la Comisión de Errores Congénitos del Metabolismo, y de la Asociación Española de Cribado Neonatal (AECNE), que desde 1985 y durante 33 años recogieron los datos de actividad de los centros de cribado y establecieron un foro de debate, intercambio de conocimientos y colaboración entre ellos y con las autoridades sanitarias. De ellas, destaca el importante papel de la Asociación Española de Errores Congénitos del Metabolismo (AECOM) desde 1999 en el diagnóstico, seguimiento y tratamiento de los pacientes. Finalmente, se contempla el papel de las familias y los aspectos psicosociales del programa, así como la evolución del movimiento asociativo, con especial mención a la fundación en 1990 de la Federación Española de PKU y otros trastornos (FAEPKU) (que pasó después a llamarse la Federación Española de Enfermedades Metabólicas Hereditarias) y en 1999 de la Federación Española de Enfermedades Raras (FEDER). Estas asociaciones han contribuido notablemente al empoderamiento de los pacientes, a apoyar la investigación y la formación y a establecer una red de colaboración y soporte para los pacientes y sus familias. Y aunque están en contacto y colaboran con las autoridades sanitarias, hasta el momento no han participado en la elaboración de decisiones y en la gobernanza de los programas. El espíritu de superación y mejora ha marcado la evolución de los programas durante este medio siglo al incluir el desarrollo de sus aspectos éticos, legales y sociales. Se avecinan desafíos tecnológicos importantes y habrá que saber utilizarlos con eficiencia, proporcionalidad y justicia en el mejor interés del niño y, por extensión, de la familia y de la sociedad.