Incidence and mortality from adverse effects of medical treatment in the UK, 1990-2013: levels, trends, patterns and comparisons.

OBJECTIVE: To present an update on incidence and mortality from adverse effects (AEs) of medical treatment in the UK, its four countries and nine English regions between 1990 and 2013. DESIGN: Descriptive epidemiological study on AEs of medical treatment. AEs are shown as a single cause-of-injury category from the Global Burden of Disease (GBD) 2013 study. DATA SOURCES: The GBD 2013 interactive data visualisation tools 'Epi Visualisation' and 'GBD Compare'. OUTCOME MEASURES: The means of incidence and mortality rates with 95% uncertainty intervals (UIs). The estimates are age-standardised. RESULTS: Incidence rate was 175 and 176 cases per 100 000 men, 173 and 174 cases per 100 000 women in 1990 and 2013, in the UK (UI 170-180). The mortality from AEs declined from 1.33 deaths (UI 0.99-1.5) to 0.92 deaths (UI 0.75-1.2) per 100 000 individuals in the UK between 1990 and 2013 (30.8% change). Although mortality trends were descending in every region of the UK, they varied by geography and gender. Mortality rates in Scotland, North East England and West Midlands were highest. Mortality rates in South England and Northern Ireland were lowest. In 2013, age-specific mortality rates were higher in males in all 20 age groups compared with females. CONCLUSIONS: Despite gains in reducing mortality from AEs of medical treatment in the UK between 1990 and 2013, the incidence of AEs remained the same. The results of this analysis suggest revising healthcare policies and programmes aimed to reduce incidence of AEs in the UK.

Association of a Crime Prevention Program for Boys With Mortality 72 Years After the Intervention: Follow-up of a Randomized Clinical Trial.

Importance: Mortality is an important outcome in evaluating crime prevention programs, but little is known about the effects on mortality during the full life course. Objective: To determine the long-term outcomes of a crime prevention program on mortality and whether the iatrogenic effects on mortality observed in middle age persist or change in old age. Design: This longitudinal follow-up was conducted in a cohort of boys included in a matched-pair randomized clinical trial (the Cambridge-Somerville Youth Study). Six hundred fifty boys aged 5 to 13 years who lived and attended public and parochial schools in working-class areas of Cambridge and Somerville, Massachusetts, and were identified as at risk for antisocial behavior were matched by age and demographic characteristics. One member of each pair was randomly allocated to the treatment condition. The original trial was performed from June 1, 1939, to December 1945. Follow-up in the present analysis was performed from January 2016 through June 2018. Interventions: Treatment group participants received individual counseling through a range of activities and home visits for an extended duration (mean, 5.5 years). Control group participants received no special services. Main Outcomes and Measures: The 4 outcomes of interest include age at mortality, mortality at latest follow-up, premature mortality (younger than 40 years), and cause of mortality (natural vs unnatural). Results: In the original analysis, 650 participants were matched and randomized to treatment or control conditions, of whom 506 were retained in the analysis (mean [SD] age, 9.8 [1.7] years). Through early 2018, records for 488 participants (96.4%) were located. A total of 446 participants were confirmed dead (88.1%) and 42 alive (8.3%). Matched-pairs analyses showed no significant differences between the treatment and control groups for mortality at latest follow-up (relative risk [RR], 1.05; 95% CI, 0.99-1.11), premature mortality (RR, 1.15; 95% CI, 0.55-2.43), or cause of mortality (RR, 1.19; 95% CI, 0.65-2.18) (P > .05 for all). Cox proportional hazard regression indicated no difference in time to death between groups (hazard ratio, 1.18; 95% CI, 0.98-1.41; P = .09). Conclusions and Relevance: Iatrogenic effects on mortality were not detected in this long-term follow-up. The longitudinal analysis provides information on the utility of life-long assessments of crime prevention programs and draws attention to the need for quality-of-life assessments of participants and their children.

[Mortality due to medical and surgical complications, economic crisis and health spending in Spain, 2002-2013]. / Mortalidad por complicaciones médicas y quirúrgicas, impacto de la crisis y gasto sanitario en España, 2002-2013.

OBJECTIVE: To describe the evolution of mortality risks for complications due to medical care or surgery between the periods prior to (2002-2007) and after (2008-2013) the beginning of the economic crisis for Spain and by autonomous region, and to analyse the relationship between the changes in the risks of death and the socioeconomic impact of the crisis and the variation in health spending. METHOD: Ecological study based on age-standardized mortality rates, synthetic index of vulnerability as a socioeconomic indicator and variation in health expenditure as an indicator of health expenditure. The relative risk of death between periods was estimated with Poisson regression models. RESULTS: The number of deaths increased for Spain in the period studied. Although the relationship between the increase in public investment in health and the decrease in mortality due to this cause has not been clearly demonstrated, it was possible to determine that the autonomous regions with the lowest increase in health expenditure had rates higher than the rest throughout the period, and that the most vulnerable to the crisis and with the lowest increase in spending presented the greatest increase in the risk of death between the periods. CONCLUSIONS: Given the increase in these deaths, due to avoidable failures of the system, it is necessary to continue investigating this cause of mortality.

[How to determine outcomes for clinical studies]. / Was soil ich messen? Bestimmen einer Zielgrösse für klinische Studien.

Outcomes represent an essential part of clinical studies because they direct interpretation. Investigators should agree on outcomes that reflect their research question best. If the focus is on clinical aspects investigators should include patient-important outcomes. On the other hand, if mechanisms in the development or progression of diseases are of interest physiological parameters might be the better choice. Selection of outcomes may impact substantially on the study design and analysis because confounding factors could differ across different outcomes. Finally, existing literature should also be considered in order to select outcomes that were used in previous studies. Thereby, appreciation and summary of the overall evidence is facilitated.

Five theses concerning the clinical consequences of pathology and prognostic factors.

We discuss possible justifications to split study populations from a biometrical point of view. The existence of prognostic differences between subgroups are neither a sufficient nor a necessary reason to justify a splitting decision. There are essentially two separate types of relevant arguments to justify a split of patient study populations: a) Different toxicity/benefit trade-offs concerning the acceptability of a particularly aggressive treatment, b) Evidence for strong treatment by subgroup interactions, i.e. Treatment differences differ markedly by biologically defined subgroups. The latter is what the research ideal of biologically specific treatment asks for. Subgroup analysis is notoriously difficult. Formal statistical analysis must be complemented by specific evidence from basic sciences. Meta-subgroup analyses may be an option if a biologically specific hypothesis on which treatment component interacts with what biological feature allows to operationally identify all those randomised trials in which the effect should be present. In this conceptual and methodological paper we defend five theses concerning the clinical consequences of pathological and biological differences from a somewhat unorthodox biometrical point of view.

Necropsias de neonatos, fator da melhoria da qualidade nas UTIs neonatais / Neonatal necropsies as a factor in quality improvement of the neonatal ICUs

Neste estudo foram estudados 552 casos de necropsia de neomortos provenientes de unidades de terapia intensiva neonatais (UTINs). Desses, 265 apresentaram algum tipo de enfermidade ou lesão não esperada conseqüentes (direta ou indiretamente) a seu manuseio diagnóstico e/ou terapêutico. Os casos foram agrupados por tipo de enfermidade, em seus respectivos órgãos ou sistemas, que ressaltou a prevalência de lesões pulmonares, como membrana hialina, enfisema intersticial, displasia broncopulmonar e alterações graves em nível de sistema nervoso central (SNC), sinalizando o prognóstico quanto à qualidade de vida. Como parte das medidas terapêuticas, devem ser analisados os acessos arteriais e venosos dos vasos umbilicais, com suas complicações, e o acesso venoso profundo, propriamente dito, para nutrição parenteral total, com graves complicações fatais para o lado do coração, como endocardite fúngica e tamponamento cardíaco por "Intralipid". Foram discutidas as resultantes multissistêmicas dos quadros de hipotensão e choque: enterocolite necrotizante e necroses corticomedular, renal, hepática e miocárdica. Este trabalho ressalta o valor da necropsia na melhoria da qualidade das UTINs, bem como apresenta várias situações em que o diagnostico só foi conhecido devido à necropsia ou, então, o resultado modificou, de certa forma, a abordagem terapêutica futura. A consulta e a análise da literatura demonstram a virtual inexistência de metodologia adequada para desenvolver e estabelecer um comportamento que propicie o exercício sistemático de aferição do desempenho organizacional, e que reduza sensivelmente as possibilidades de efeitos indesejáveis relacionados com rotinas e procedimentos operacionais nesse campo da prática assistencial. As principais causas de insucesso parecem ser creditadas à tecnologia de máquinas e substâncias, cuja adequação à biologia dos organismos em desenvolvimento não é plenamente conhecida no que se refere à influência...

The present study emphasizes the necropsy value in the development of the neonatal ICU. We present many situations where the diagnostic was possible solely because of the necropsy, as well, many diagnosis were changed based on the necropsies results. The literature compilation shows no evidence of a systematic procedure concerning the mitigation of the problems related to the avaliable routines in this matter. The lack of a more scientific investigation related to the neonatal deaths is a enormous barrier to the improvement of those organizations (ITU's). Apparently, these failure is connected to machines and products thecnology not well know in terms of their suitability concerning under biological development organisms. Also, the necropsies appears to be a useful tool when the death results, directly or indirectly, from therapeutical process. The conception of a quality development process strategy represents a major issue, even more when you face new political decisions in health field, including cost reduction and higher complexity. Also, we need to pay special attention to science and research ethical principles.