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BACKGROUND: Globally, >300 million patients have surgery annually, and ≤20% experience adverse postoperative events. We studied the impact of both cardiac and noncardiac adverse events on 1-year disability-free survival after noncardiac surgery. METHODS: We used the study cohort from the Evaluation of Nitrous oxide in Gas Mixture of Anesthesia (ENIGMA-II) trial, an international randomized trial of 6992 noncardiac surgical patients. All were ≥45 years of age and had moderate to high cardiac risk. The primary outcome was mortality within 1 postoperative year. We defined 4 separate types of postoperative adverse events. Major adverse cardiac events (MACEs) included myocardial infarction (MI), cardiac arrest, and myocardial revascularization with or without troponin elevation. MI was defined using the third Universal Definition and was blindly adjudicated. A second cohort consisted of patients with isolated troponin increases who did not meet the definition for MI. We also considered a cohort of patients who experienced major adverse postoperative events (MAPEs), including unplanned admission to intensive care, prolonged mechanical ventilation, wound infection, pulmonary embolism, and stroke. From this cohort, we identified a group without troponin elevation and another with troponin elevation that was not judged to be an MI. Multivariable Cox proportional hazard models for death at 1 year and assessments of proportionality of hazard functions were performed and expressed as an adjusted hazard ratio (aHR) and 95% confidence intervals (CIs). RESULTS: MACEs were observed in 469 patients, and another 754 patients had isolated troponin increases. MAPEs were observed in 631 patients. Compared with control patients, patients with a MACE were at increased risk of mortality (aHR, 3.36 [95% CI, 2.55-4.46]), similar to patients who suffered a MAPE without troponin elevation (n = 501) (aHR, 2.98 [95% CI, 2.26-3.92]). Patients who suffered a MAPE with troponin elevation but without MI had the highest risk of death (n = 116) (aHR, 4.29 [95% CI, 2.89-6.36]). These 4 types of adverse events similarly affected 1-year disability-free survival. CONCLUSIONS: MACEs and MAPEs occur at similar frequencies and affect survival to a similar degree. All 3 types of postoperative troponin elevation in this analysis were associated, to varying degrees, with increased risk of death and disability.
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Anestésicos Inalatórios/efeitos adversos , Cardiopatias/epidemiologia , Óxido Nitroso/efeitos adversos , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Administração por Inalação , Idoso , Anestésicos Inalatórios/administração & dosagem , Biomarcadores/sangue , Avaliação da Deficiência , Feminino , Nível de Saúde , Cardiopatias/diagnóstico , Cardiopatias/mortalidade , Cardiopatias/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Óxido Nitroso/administração & dosagem , Medição de Risco , Fatores de Risco , Procedimentos Cirúrgicos Operatórios/mortalidade , Fatores de Tempo , Resultado do Tratamento , Troponina/sangue , Regulação para CimaRESUMO
BACKGROUND: Emergency contraception (EC) is an effective postcoital contraceptive method for reducing the risk of unwanted pregnancy after unprotected intercourse. The estimated effectiveness of EC is between 70 and 89% if taken within 72 h following intercourse. Most of the studies carried out in Spain are quantitative and from the perspective of health professionals. In this study, we intend to explore the knowledge of, attitudes towards and discourse regarding the use of EC in women aged 15 to 25 years. METHODS: Sample: A qualitative study including in-depth interviews with 19 women between 15 and 25 years of age was performed. INCLUSION CRITERIA: Participants were natives of Spain or of a Latin American country. Segmentation criteria: Participants had experience in the use of EC. DATA COLLECTION: Participants were selected by health care informants and by the snowball technique among university students. DATA ANALYSIS: A thematic analysis was performed. Preliminary analyses were made during the course of the field work to adapt the script and to assess data saturation. A preliminary code tree was developed by two researchers, and the coding of the text was done with the Atlas.ti 5.0 software. RESULTS: EC is perceived positively by women. They do not express issues with taking it, although some feel guilty. The reason for taking EC is to avoid unwanted pregnancy and abortion. Women also feel that EC should be used in moderation. False beliefs and misconceptions regarding EC are held: EC delivers an excess of hormones, induces abortion and causes severe side effects. Women mention that the health professionals who provide EC have moral beliefs. Women use it because of condom breakage associated with their first coital relations. CONCLUSIONS: The results of this study have public health implications: The sexual-affective health education received by young people should incorporate clear information about the mechanism of action of the EC pill and its side effects together with empowerment strategies addressing guilt and moralistic messages. Programmes and training activities for health professionals must be designed to prevent the communication of inappropriate messages such as those that exaggerate the side effects of EC and those that promote fear and guilt, because they represent a barrier to the responsible use of this medication.
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Anticoncepção Pós-Coito , Conhecimentos, Atitudes e Prática em Saúde , Adolescente , Adulto , Feminino , Humanos , Pesquisa Qualitativa , Espanha , Adulto JovemRESUMO
OBJECTIVE: The aim of our study was to determine the self-reported prevalence of use of emergency contraception (EC), identify factors associated with EC use, and measure the prevalence in university students of pregnancy and abortion among users and non-users of EC. METHODS: A cross-sectional descriptive study of university students using a self-administered questionnaire was carried out in 2016. The main dependent variable was EC use at any time. Independent variables included sociodemographic factors and factors related to harmful habits and sexual behaviour. RESULTS: The study sample consisted of 1309 students (median age 20 years). Forty per cent of participants reported using EC; condom failure was given as the main reason. Variables associated with EC use in both men and women were illegal drug consumption and having had more than 10 sexual partners. In women, other factors associated with EC use were age at first coitus and non-centrist political views. The prevalence of pregnancy was 6.5% and the prevalence of voluntary abortion was 2.9%. This prevalence was similar for men and women and for EC users and non-users. CONCLUSION: EC use in university students was more likely in those who experienced contraceptive failure or used no contraception. There were differences between men and women. Those at higher risk of unplanned pregnancy were more likely to report EC use, which may explain why there was no difference in the rates of unwanted pregnancies between EC users and non-users.
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Comportamento Contraceptivo/estatística & dados numéricos , Anticoncepção Pós-Coito/estatística & dados numéricos , Assunção de Riscos , Comportamento Sexual/psicologia , Preservativos/efeitos adversos , Comportamento Contraceptivo/psicologia , Anticoncepção Pós-Coito/psicologia , Estudos Transversais , Feminino , Humanos , Masculino , Gravidez , Gravidez não Planejada/psicologia , Prevalência , Fatores de Risco , Estudantes , Inquéritos e Questionários , Universidades , Adulto JovemRESUMO
OBJECTIVES: We analysed the degree and impact of consent bias in the prospective study 'leben in der Arbeit (lidA)' after linking primary interview data with claims data from German statutory health insurance funds as well as with administrative data provided by the German Federal Employment Agency. STUDY DESIGN: Prospective cohort study. METHODS: Within two study waves (2011, 2014) primary data were collected based on computer-assisted personal interviews. During interview informed consent to data linkage was obtained. We used binary logistic regression analyses with participants' consent for record linkage as the dependent variable calculating odds ratios (ORs) and 95% confidence intervals (95% CIs) for independent variables. Several sociodemographic, socio-economic and work-related factors were modelled as potential determinants of consent. RESULTS: A total of 4244 participants took part in both waves. After excluding invalid consent, 4178 participants were included in the analysis. About 3918 (93.8%) of these participants gave their consent to link their primary data with data from at least one source. Within regression analyses only moderate bias was found due to region of residence, apprenticeship, professional affiliations, income and number of diseases. Participants from former West Germany were less likely to have their study data linked with both data sources (OR 0.63 [95% CI 0.42-0.96]) than those from the former East Germany. Participants with no information on income were more likely to refuse consent to both data sources compared to the reference group (net income: under EUR 1000; OR 0.15 [95% CI 0.08-0.30]). Respondents with two (OR 1.37 [95% CI 1.06-1.77]) or three and more diseases (OR 1.30 [95% CI 1.02-1.66]) diagnosed by a doctor agreed more frequently to linking both data sources than participants without disease. There is just a small proportion of variance in consenting explained by the models (R2: 0.063-0.085). Also, only small changes of factors' prevalence were observed in consenters. CONCLUSIONS: For the first time in Germany, the lidA-study links primary survey data with health claims and administrative employment data. We conclude that there is only a minor relation between the analysed factors and consent behaviour of the participants. A linked data set may be used in further analyses without substantial biases.
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Demandas Administrativas em Assistência à Saúde , Viés , Armazenamento e Recuperação da Informação , Consentimento Livre e Esclarecido , Fatores Etários , Emprego/estatística & dados numéricos , Feminino , Alemanha , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Although secondary data analyses have been established in recent years in health research, explicit recommendations for standardized, transparent and complete reporting of secondary data analyses do not exist as yet. Therefore, between 2009 and 2014, a first proposal for a specific reporting standard for secondary data analysis was developed (STROSA 1). Parallel to this national process in Germany, an international reporting standard for routine data analysis was initiated in 2013 (RECORD). Nevertheless, because of the specific characteristics of the German health care system as well as specific data protection requirements, the need for a specific German reporting standard for secondary data analyses became evident. Therefore, STROSA was revised and tested by a task force of 15 experts from the working group Collection and Use of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) as well as from the working group Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF). The consensus STROSA-2 checklist includes 27 criteria, which should be met in the reporting of secondary data analysis from Germany. The criteria have been illustrated and clarified with specific explanations and examples of good practice. The STROSA reporting standard aims at stimulating a wider scientific discussion on the practicability and completeness of the checklist. After further discussions and possibly resulting modifications, STROSA shall be implemented as a reporting standard for secondary data analyses from Germany. This will guarantee standardized and complete information on secondary data analyses enabling assessment of their internal and external validity.
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AIM: In the BMBF-funded lidA study - leben in der Arbeit - hand grip strength is taken as an objective measure for describing the health of the study population. The aim is to analyse the association of grip strength with characteristics of subjective health and work ability. METHODS: During the 1(st) investigation in 2011 there were 6 585 interviews with employed persons born in 1959 and 1965 and subject to social insurance contributions. The survey included aspects of employment and health. The maximum isometric hand grip strength was determined with a dynamometer from a series of 4 measurements. The examination refers to 6 195 employed persons who approved the realisation of the grip strength test. The determinants of grip strength are analysed bivariately based on non-parametric methods and examined concerning their relative importance using a multiple linear regression. RESULTS: In the descriptive analyses statistically significant median differences (p<0.05) appear between men and women as well as persons of the younger and older cohort. After excluding implausible values some statistically significant differences in grip strength can be observed between the categories of current health condition, physical and mental work ability and the number of pain localisations. The trend for the larger grip strength occurrences can be noted in the categories of better health and work ability plus a smaller number of pain localisations. From the combined analysis of the explanatory variables of age, BMI, health and work ability within the estimated regression model results a corrected R² of 0.036 for men or, respectively, 0.05 for women. CONCLUSION: Between the categories of selected health and work ability related variables some statistically significant differences of grip strength (± 0.0-4.0 kg) were observed. However, the variability of grip strength cannot be explained sufficiently by the data used. Although the results obtained support the preliminary assumptions, the relevance of this matter could not be resolved adequately with the data under consideration. Given that analysing grip strength is important in the individual temporal process, the results will be extended by longitudinal analyses to facilitate the analysis of hand grip strength as predictor of the development of individual health.
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Força da Mão , Nível de Saúde , Competência Profissional/estatística & dados numéricos , Avaliação da Capacidade de Trabalho , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Estatística como Assunto , Inquéritos e QuestionáriosRESUMO
AIM: Mental diseases are highly prevalent and of increasing meaning for absenteeism. The association of absenteeism with vertical and horizontal dimensions of socioeconomic status is well-known. Against this background we investigated the independent association between mental diseases and absenteeism or long-time absenteeism of socioeconomic aspects. MATERIAL AND METHODS: Basis of this nationwide exploratory survey were the 6 339 employees born in 1959 or 1965 and subject to statutory health insurance of the first wave of the lidA-cohort study 2011. The stepwise logistic regression analysis was used for the investigation of the effects of mental diseases on absenteeism or long-term absenteeism after adjustment for education, occupational position, income, gender, age, working-time and -stress. RESULTS: After adjustment for socioeconomic factors highly significant associations between mental diseases and absenteeism or even more long-term absenteeism were observed. These associations stayed significant after additional adjustment for work-related factors. CONCLUSION: Mental diseases were independent of sociodemographic factors and work-related factors (working-time and -stress) associated with absenteeism or with long-term absenteeism. Unspecific programmes for the prevention and rehabilitation of mental diseases may contribute to the reduction of absenteeism. Apart from that causes of absenteeism in highly affected socioeconomic groups should be investigated.
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Absenteísmo , Transtornos Mentais/epidemiologia , Transtornos Mentais/psicologia , Licença Médica/estatística & dados numéricos , Estresse Psicológico/epidemiologia , Estresse Psicológico/psicologia , Adulto , Distribuição por Idade , Emprego/estatística & dados numéricos , Feminino , Alemanha/epidemiologia , Humanos , Renda/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Prevalência , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e Especificidade , Distribuição por Sexo , Fatores Socioeconômicos , Estatística como Assunto , Carga de Trabalho/psicologia , Carga de Trabalho/estatística & dados numéricos , Adulto JovemRESUMO
Since 1970 the health insurance system in Germany has shrunk by more than 90% to 132 statutory health insurance funds (SHI) at present. For studies using data from different SHI, this development means a reduction of contacts and a higher workload when requesting data. The latter is due to the fact that fusions bind resources in the health insurance funds. In order to avoid selection in studies among the insured, all SHI must be contacted. Additionally, 15 controlling institutions on the state and national level have to agree as determined in § 75 of the German Social Code number 10. The lidA study - a German cohort study on work, age and health intends to link primary and secondary data from all SHI of those insured who have given their agreement for participation. Since the beginning of the study in 2009 the number of SHI has been reduced by 70. Of the 6 585 interviews in 2011 approximately half of the interviewees agreed in written form that their individual health insurance data can be linked. This portion of the insured is dispersed among 95 SHI. At this point, 11 contracts with SHI are realised (approximately 50% of the insured) and 8 data controlling authorities have been contacted. The problems involved in the fusion of SHI and its meaning for research are explained in this article. The fusion of SHI makes sense for the long term. It will lead to a reduction of contacts and contracts that researchers have to establish in order to analyse the data. Therefore, this article also discusses the alternative of creating a meta-data set of all the data from the different SHI combined.
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Confiabilidade dos Dados , Conjuntos de Dados como Assunto , Registros Eletrônicos de Saúde/organização & administração , Pesquisa sobre Serviços de Saúde/organização & administração , Registro Médico Coordenado/métodos , Programas Nacionais de Saúde/organização & administração , Sistemas de Gerenciamento de Base de Dados , Estudos de Viabilidade , Alemanha , Armazenamento e Recuperação da Informação/métodos , Uso Significativo/organização & administração , Integração de SistemasRESUMO
OBJECTIVE: The lidA Study is designed as a longitudinal survey. The respondent's consent is mandatory for storing sample data. Moreover, the survey data shall be linked with social security data of the Federal Employment Agency and individual's health insurance claims data in case of the respondent's written consent. This essay pursues the issue of whether this methodologically challenging objective of obtaining 3 consents within one study could be met without any selectivity. METHODOLOGY: The data basis is a cohort study with 2 cohorts of a representative sample of employed individuals subject to social security contributions. The sample was interviewed for the first time in 2011. The analysis dataset comprises 6 585 respondents. RESULTS: Selectivity analyses prove that the realisation of the first measurement's sample turned out to be representative as well as unbiased. As expected, more respondents stated their willingness to remain in the panel and also consented to linkage of social security data than those who consented to linkage of health insurance claims data. All 3 consents were given without resulting in any bias. Even linking all 3 consents does result in minimal effects of a few subgroups only. CONCLUSION: A significant number of respondents can be motivated to participate due to proper placement of the questions concerning consent and the provision of insight into the use of the data.
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Confidencialidade , Registros Eletrônicos de Saúde/estatística & dados numéricos , Registros de Saúde Pessoal , Consentimento Livre e Esclarecido/estatística & dados numéricos , Revisão da Utilização de Seguros/estatística & dados numéricos , Registro Médico Coordenado , Adulto , Feminino , Alemanha , Humanos , Masculino , Programas Nacionais de Saúde/estatística & dados numéricos , Previdência Social/estatística & dados numéricos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Demographic change is leading to a shrinking and ageing workforce in industrialized nations. Therefore, sickness absence may become a relevant problem. Increasing absenteeism and retirement rates due to mental disorders raise the question of an association between work-related stress and sickness absence. Studies on this matter, particularly in older employees, are rare. OBJECTIVES: We studied for the first time in Germany the relationship between effort-reward imbalance (ERI) and overall or long-term sickness absence. MATERIALS AND METHODS: LidA ( "Living at Work") is a German cohort study on work, age, health, and work participation. A total of 6,339 employees born in 1959 and 1965 who were subject to social insurance contributions were interviewed nationwide using a representative sample concept. The response rate was 27.3 %. The sample showed high representativeness and no selectivity relating to 16 sociodemographic items. Sickness absence was defined as at least one long-term sickness absence with at least 43 days of absenteeism. Work-related stress was parameterized by ERI tertiles. Multiple logistic regression adjusting for age, sex, mental disorders, social status, and working time was performed. RESULTS: High levels of work-related stress were significantly associated with overall and long-term sickness absence among older employees after adjusting for covariates. CONCLUSIONS: Our unique findings on work-related stress and sickness absence in Germany are in agreement with the results of most international studies. Reducing work-related stress could help to preserve the workforce.
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Esgotamento Profissional/epidemiologia , Emprego/estatística & dados numéricos , Satisfação no Emprego , Transtornos Mentais/epidemiologia , Licença Médica/estatística & dados numéricos , Adulto , Distribuição por Idade , Comorbidade , Estudos Transversais , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Aposentadoria/estatística & dados numéricos , Fatores de Risco , Distribuição por Sexo , Classe Social , Adulto JovemRESUMO
In Germany, research on health-care services addresses many topics within a regional context, and it predominantly uses a single (typically secondary) data sources for this purpose. The specific disadvantages and methodological challenges associated with these data sources may limit analysis. Various data sources break the data down by region and may be of interest in regional health-care research. Linking multiple data sources (data linkage) could therefore expand analysis options in this area. Researchers in this field are currently discussing various approaches for using data linkage to overcome the respective weaknesses of primary and secondary data. This contribution covers the various types of data linkage (on an aggregate or individual level) and their potentials and limitations in small area health services research. The focus lies on individual data linkage, which requires written informed consent. Taking into account methodological and particularly data protection challenges, conclusions are drawn regarding future application areas and options of small area health services research and specific examples are provided.
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Serviços de Saúde Comunitária/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/métodos , Registro Médico Coordenado/métodos , Sistemas Computadorizados de Registros Médicos/estatística & dados numéricos , Serviços de Saúde Rural/estatística & dados numéricos , Saúde da População Rural/tendências , Análise de Pequenas Áreas , Alemanha , Política de SaúdeRESUMO
BACKGROUND: Statutory skin cancer screening (gHKS) can counteract severe courses of various types of skin cancer. The example of malignant melanoma shows that screening is important for older adults in view of the average age of onset of this disease: 62 (women) and 68 years (men). For Saxony-Anhalt (ST), as a state particularly affected by demographic change, little gHKS data are available regarding its usage. OBJECTIVES: For the study, gHKS participation rates for persons aged 55 and older are presented for ST in comparison to the rest of Germany. Reasons for and barriers to participation from those eligible as well as possible fields of action are shown. MATERIALS AND METHODS: For the target group, outpatient billing data from the Central Institute for Statutory Health Insurance Physicians in Germany (Zi) on gHKS from 2011-2020 are cross-sectionally and longitudinally analysed. Guideline-based telephone interviews with 18 residents using qualitative content analysis according to Kuckartz serve to identify reasons for and barriers to the use of gHKS. RESULTS: The gHKS was rarely and irregularly used in ST and other federal states of Germany from 2011-2020; the annual utilisation rate was about 8.0% (national average: 8.4%). Between 2011 and 2020, 50% of eligible people aged 55 years and older did not participate in the gHKS. The highest utilisation rates were among men aged 70-79 years. In addition to district-specific differences, which indicate possible gaps in care, information deficits appear to be the main reason for low participation. CONCLUSION: The low utilisation of gHKS, partly due to a lack of information among those entitled to it, requires target group-specific information services.
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Melanoma , Neoplasias Cutâneas , Idoso , Feminino , Humanos , Masculino , Envelhecimento , Detecção Precoce de Câncer , Alemanha/epidemiologia , Neoplasias Cutâneas/diagnóstico , Pessoa de Meia-IdadeRESUMO
Within the scope of an aging population, the topic age, work and health becomes more and more important. So far, research in occupational epidemiology utilizes various primary or secondary data sources. However, data linkage has rarely been used as an instrument in this field. The study presented here combines two large databases within a so-called "age-work matrix", stratified by sex, age group and occupational group. This matrix is based on the German classification of occupations and uses its occupation codes as a key variable. The first database is the representative BIBB/BAuA employment survey for employees of all occupations in Germany 2005/06. The second database consists in sickness absence data of the insurees of a German statutory health insurance fund. Using the matrix approach, the study investigates associations of reported subjectively perceived psychosocial work strains and health impairments provided by health insurance claims data. These claims data offer sickness absence data as an indicator for health impairments. Usability of sickness absence data for studies in occupational epidemiology, their methodological challenges and the solutions realized in this study are discussed.
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Interpretação Estatística de Dados , Emprego/estatística & dados numéricos , Métodos Epidemiológicos , Registro Médico Coordenado/métodos , Doenças Profissionais/epidemiologia , Licença Médica/estatística & dados numéricos , Distribuição por Idade , Alemanha/epidemiologia , Humanos , Distribuição por SexoRESUMO
BACKGROUND: This study aimed to determine whether oral health services provision by a dental student clinical outplacement embedded within a Community Controlled Health Service positively impacted a rural Indigenous community and to explore the nature of these benefits. METHODS: Aggregated and de-identified 2017, 2018 and 2019 student-led clinic services provision data were retrospectively analysed. The change in services mix over time was measured. Rural outplacement clinic operational costs to the university were estimated. Government-funded local public dental clinic waiting list and services provision data were used to identify any student clinic establishment effect. RESULTS: The student-led clinic services mix shifted over time from mainly acute care for toothache towards prevention of disease and tooth restoration, indicating an improvement in patient oral health and correspondingly reduced system costs. Imputed value of 2017-2019 student-led clinic services provision totalled almost AUD$1 million. Government public clinic waiting list times decreased after full establishment of the student-led clinic, indicating decreased pressure on the public system. CONCLUSION: The Community Controlled Health Service and university partnership improved community oral health care access, its timely delivery and simultaneously provided valuable human capital development from the student training experience. The student-led clinic's targeted Indigenous community showed oral health improvement over time. © 2023 Australian Dental Association.
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Serviços de Saúde do Indígena , Serviços de Saúde Rural , Humanos , Austrália , Estudos Retrospectivos , Estudantes , Atenção Primária à SaúdeRESUMO
A patient with structural valve degeneration of an aortic bioprosthesis with stenosis stage 3 underwent valve-in-valve transcatheter aortic valve replacement (TAVR) at 29 weeks with improvement. This is the first reported TAVR in the third trimester. TAVR may be an alternative to preterm delivery in cases of symptomatic aortic stenosis.
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In the German health service research there exists, unlike in labour market research, no experience with the combination of personal primary and secondary data. One of the reasons for this is, among other things, data protection. The lidA cohort study analyses persons in employment (excluding civil servants and self-employed), born in 1959 and 1965. It is intended to give answers to questions from the health services research as well as from the labour market research. It relies on different primary and secondary data sources: survey data, process data from the Federal Employment Agency, aggregated and individual health insurance data. The experiences made in the lidA study, in addition to the data protection needs and the expenditures for the implementation, are summarised as "best practice". The procedure for the application process according to § 75 SGB X, the directive to develop data security concepts, the informed consent for the linkage of personal information are described and the importance of a transparent approach is explained. So far it has been shown that the preparation and approval process for the release of the actual data, both within the project consortium, but also with external parties such as health insurance companies or the responsible data protection officer, requires a major effort. In view of all the identified legal and organisational challenges, our findings should be extremely useful for answering different research questions in the fields of labour market and health services research. In combination with primary data, they may even represent a "gold standard" for epidemiology and health services research.
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Estudos de Coortes , Confidencialidade/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Controle de Formulários e Registros/legislação & jurisprudência , Regulamentação Governamental , Registros de Saúde Pessoal , Registro Médico Coordenado/métodos , Controle de Formulários e Registros/métodos , AlemanhaRESUMO
BACKGROUND: The different incidence rates of, and risk factors for, depression in different countries argue for the need to have a specific risk algorithm for each country or a supranational risk algorithm. We aimed to develop and validate a predictD-Spain risk algorithm (PSRA) for the onset of major depression and to compare the performance of the PSRA with the predictD-Europe risk algorithm (PERA) in Spanish primary care. METHOD: A prospective cohort study with evaluations at baseline, 6 and 12 months. We measured 39 known risk factors and used multi-level logistic regression and inverse probability weighting to build the PSRA. In Spain (4574), Chile (2133) and another five European countries (5184), 11 891 non-depressed adult primary care attendees formed our at-risk population. The main outcome was DSM-IV major depression (CIDI). RESULTS: Six variables were patient characteristics or past events (sex, age, sex×age interaction, education, physical child abuse, and lifetime depression) and six were current status [Short Form 12 (SF-12) physical score, SF-12 mental score, dissatisfaction with unpaid work, number of serious problems in very close persons, dissatisfaction with living together at home, and taking medication for stress, anxiety or depression]. The C-index of the PSRA was 0.82 [95% confidence interval (CI) 0.79-0.84]. The Integrated Discrimination Improvement (IDI) was 0.0558 [standard error (s.e.)=0.0071, Zexp=7.88, p<0.0001] mainly due to the increase in sensitivity. Both the IDI and calibration plots showed that the PSRA functioned better than the PERA in Spain. CONCLUSIONS: The PSRA included new variables and afforded an improved performance over the PERA for predicting the onset of major depression in Spain. However, the PERA is still the best option in other European countries.
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Transtorno Depressivo Maior/diagnóstico , Transtorno Depressivo Maior/epidemiologia , Medição de Risco/métodos , Adolescente , Adulto , Idoso , Algoritmos , Europa (Continente) , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Atenção Primária à Saúde , Estudos Prospectivos , Fatores de Risco , Espanha/epidemiologia , Inquéritos e Questionários , Adulto JovemRESUMO
The data linkage of health-related primary and secondary data provides new opportunities for health services research. The advantages of both data sources can be used synergistically, in this way their disadvantages can be overcome. In the context of the evaluation of a health intervention - the integrated health services project ('Gesundes Kinzigtal') - the conditions and requirements for an individualised data linkage of primary data (survey) and claims data of a statutory health insurance are described in this paper. The integration of secondary data permits us not only to assess the intervention concerning physical activity, nutrition and social participation of elderly people ('AGil') but, above all, also to measure and analyse the program effects on the utilisation of health care services. Recommendations regarding the data linkage of primary and secondary data in health services research are derived from the results and experiences of the AGil study. Suggestions are made concerning the suitable pseudonymisation algorithm for primary and secondary data, the matching method, approaches to reduce mismatching and their validation, as well as the legal basis for such a data linkage. Overall, an individualised data linkage of primary and secondary data does not pose any technical problems. Nevertheless a couple of data protection rules have to be followed; the data linkage offers a high knowledge insight to many health and epidemiological research questions and might be the new gold standard for health services research.
Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Coleta de Dados/métodos , Mineração de Dados/métodos , Bases de Dados Factuais , Revisão da Utilização de Seguros/estatística & dados numéricos , Reembolso de Seguro de Saúde/estatística & dados numéricos , AlemanhaRESUMO
Animal welfare in livestock production is of great interest to consumers. The organic farming approach strives to ensure animal welfare based on preventive measures, but there are very few scientific studies that compare the actual differences in animal welfare between organic and conventional farms. Those studies that have been carried out frequently focus on specific aspects of animal welfare, mostly health issues. The aim of the present study, therefore, was to investigate the effects of the farming system on the welfare of dairy cows in a more holistic way. Although this study was carried out in just two federal states of Germany, the results could serve as a suitable model for the whole country. We used the Welfare Quality assessment protocol to measure welfare for dairy cattle (Welfare Quality®, 2009) and the results showed significant differences (P < 0.05) between organic and conventional farms, but there was also considerable variance between individual farms of the same farming system. Organic farms scored higher in all four Welfare Quality® principles: "Good Feeding", "Good Housing", "Good Health" and "Appropriate Behavior" compared to conventional farms. In particular, organic farms obtained higher scores with respect to Welfare Quality® measures of resting comfort, which contributes to a lower percentage of lameness; organic farms also implemented less painful methods for disbudding, or indeed carried out no disbudding, and provided access to pasture and outdoor exercise. However, organic farms still have room for improvement, especially with respect to animal health. Therefore, outcome-based specifications should be included in the current (purely action-oriented) European regulation of organic production (EC, 2008; EU, 2018) to safeguard the health-related aspects of animal welfare.