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1.
BMC Pediatr ; 24(1): 405, 2024 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-38909207

RESUMO

BACKGROUND: Nine in every thousand children born in the United Kingdom have congenital heart disease, and 250,000 adults are living with the condition. This study aims to investigate the associations between congenital heart disease and educational outcomes among school-aged children in Scotland. METHODS: Routine health and education databases were linked to produce a cohort of all singleton children born in Scotland and attending a local authority run primary, secondary, or special school in Scotland at some point between 2009 and 2013. Children with congenital heart disease within this cohort were compared with children unaffected by congenital conditions. Outcomes investigated were special educational need (SEN), absenteeism, exclusion, academic attainment, and unemployment. All analyses were adjusted for sociodemographic and maternity confounders. Absenteeism was investigated as a mediating factor in the associations with attainment and unemployment. RESULTS: Of the 715,850 children, 6,295 (0.9%) had congenital heart disease and 4,412 (6.1%) had isolated congenital heart disease. Congenital heart disease and isolated congenital heart disease were both significantly associated with subsequent special educational need (OR 3.45, 95% CI 3.26-3.65, p < 0.001 and OR 1.98, 95% CI 1.84-2.13, p < 0.001 respectively), absenteeism (IRR 1.13, 95% CI 1.10-1.16, p < 0.001 and IRR 1.10, 95% CI 1.06-1.13, p < 0.001 respectively), and low academic attainment (OR 1.69, 95% CI 1.39-2.07, p < 0.001 and OR 1.35, 95% CI 1.07-1.69, p = 0.011 respectively). Neither congenital heart disease nor isolated congenital heart disease were associated with school exclusion. Only congenital heart disease (OR 1.21, 95% CI 1.03-1.42, p = 0.022) but not isolated congenital heart disease was associated with unemployment. When days absent were included in the analyses investigating attainment and unemployment, the conclusions were not altered. CONCLUSION: Children with congenital heart disease have greater special educational need, lower school attendance, attain lower examination grades and have greater unemployment compared to peers. In addition to healthcare support, affected children need educational support to avoid additional impact on their long-term wellbeing.


Assuntos
Absenteísmo , Cardiopatias Congênitas , Humanos , Cardiopatias Congênitas/epidemiologia , Escócia/epidemiologia , Feminino , Masculino , Criança , Desemprego/estatística & dados numéricos , Adolescente , Educação Inclusiva/estatística & dados numéricos , Sucesso Acadêmico , Escolaridade
2.
BMJ Health Care Inform ; 31(1)2024 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-38749529

RESUMO

OBJECTIVE: The objective of this paper is to provide a comprehensive overview of the development and features of the Taipei Medical University Clinical Research Database (TMUCRD), a repository of real-world data (RWD) derived from electronic health records (EHRs) and other sources. METHODS: TMUCRD was developed by integrating EHRs from three affiliated hospitals, including Taipei Medical University Hospital, Wan-Fang Hospital and Shuang-Ho Hospital. The data cover over 15 years and include diverse patient care information. The database was converted to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) for standardisation. RESULTS: TMUCRD comprises 89 tables (eg, 29 tables for each hospital and 2 linked tables), including demographics, diagnoses, medications, procedures and measurements, among others. It encompasses data from more than 4.15 million patients with various medical records, spanning from the year 2004 to 2021. The dataset offers insights into disease prevalence, medication usage, laboratory tests and patient characteristics. DISCUSSION: TMUCRD stands out due to its unique advantages, including diverse data types, comprehensive patient information, linked mortality and cancer registry data, regular updates and a swift application process. Its compatibility with the OMOP CDM enhances its usability and interoperability. CONCLUSION: TMUCRD serves as a valuable resource for researchers and scholars interested in leveraging RWD for clinical research. Its availability and integration of diverse healthcare data contribute to a collaborative and data-driven approach to advancing medical knowledge and practice.


Assuntos
Bases de Dados Factuais , Registros Eletrônicos de Saúde , Humanos , Taiwan , Hospitais Universitários
4.
Artigo em Inglês | MEDLINE | ID: mdl-38755015

RESUMO

BACKGROUND: The global prevalence of diabetes is similar in men and women; however, there is conflicting evidence regarding sex differences in diabetes-related complications. The aim of this study was to investigate sex differences in incident microvascular and macrovascular complications among adults with diabetes. METHODS: This prospective cohort study linked data from the 45 and Up Study, Australia, to administrative health records. The study sample included 25 713 individuals (57% men), aged ≥45 years, with diabetes at baseline. Incident cardiovascular disease (CVD), eye, lower limb, and kidney complications were determined using hospitalisation data and claims for medical services. Multivariable Cox proportional hazards models were used to assess the association between sex and incident complications. RESULTS: Age-adjusted incidence rates per 1000 person years for CVD, eye, lower limb, and kidney complications were 37, 52, 21, and 32, respectively. Men had a greater risk of CVD (adjusted hazard ratio (aHR) 1.51, 95% CI 1.43 to 1.59), lower limb (aHR 1.47, 95% CI 1.38 to 1.57), and kidney complications (aHR 1.55, 95% CI 1.47 to 1.64) than women, and a greater risk of diabetic retinopathy (aHR 1.14, 95% CI 1.03 to 1.26). Over 10 years, 44%, 57%, 25%, and 35% of men experienced a CVD, eye, lower limb, or kidney complication, respectively, compared with 31%, 61%, 18%, and 25% of women. Diabetes duration (<10 years vs ≥10 years) had no substantial effect on sex differences in complications. CONCLUSIONS: Men with diabetes are at greater risk of complications, irrespective of diabetes duration. High rates of complications in both sexes highlight the importance of targeted complication screening and prevention strategies from diagnosis.

5.
ACI open ; 8(1): e43-e48, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38765555

RESUMO

Background: To achieve scientific goals, researchers often require integration of data from a primary electronic health record (EHR) system and one or more ancillary EHR systems used during the same patient care encounter. Although studies have demonstrated approaches for linking patient identity records across different EHR systems, little is known about linking patient encounter records across primary and ancillary EHR systems. Objectives: We compared a patients-first approach versus an encounters-first approach for linking patient encounter records across multiple EHR systems. Methods: We conducted a retrospective observational study of 348,904 patients with 533,283 encounters from 2010 to 2020 across our institution's primary EHR system and an ancillary EHR system used in perioperative settings. For the patients-first approach and the encounters-first approach, we measured the number of patient and encounter links created as well as runtime. Results: While the patients-first approach linked 43% of patients and 49% of encounters, the encounters-first approach linked 98% of patients and 100% of encounters. The encounters-first approach was 20 times faster than the patients-first approach for linking patients and 33% slower for linking encounters. Conclusion: Findings suggest that common patient and encounter identifiers shared among EHR systems via automated interfaces may be clinically useful but not "research-ready" and thus require an encounters-first linkage approach to enable secondary use for scientific purposes. Based on our search, this study is among the first to demonstrate approaches for linking patient encounters across multiple EHR systems. Enterprise data warehouse for research efforts elsewhere may benefit from an encounters-first approach.

6.
Front Med (Lausanne) ; 11: 1301660, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38660421

RESUMO

Introduction: The potential for secondary use of health data to improve healthcare is currently not fully exploited. Health data is largely kept in isolated data silos and key infrastructure to aggregate these silos into standardized bodies of knowledge is underdeveloped. We describe the development, implementation, and evaluation of a federated infrastructure to facilitate versatile secondary use of health data based on Health Data Space nodes. Materials and methods: Our proposed nodes are self-contained units that digest data through an extract-transform-load framework that pseudonymizes and links data with privacy-preserving record linkage and harmonizes into a common data model (OMOP CDM). To support collaborative analyses a multi-level feature store is also implemented. A feasibility experiment was conducted to test the infrastructures potential for machine learning operations and deployment of other apps (e.g., visualization). Nodes can be operated in a network at different levels of sharing according to the level of trust within the network. Results: In a proof-of-concept study, a privacy-preserving registry for heart failure patients has been implemented as a real-world showcase for Health Data Space nodes at the highest trust level, linking multiple data sources including (a) electronical medical records from hospitals, (b) patient data from a telemonitoring system, and (c) data from Austria's national register of deaths. The registry is deployed at the tirol kliniken, a hospital carrier in the Austrian state of Tyrol, and currently includes 5,004 patients, with over 2.9 million measurements, over 574,000 observations, more than 63,000 clinical free text notes, and in total over 5.2 million data points. Data curation and harmonization processes are executed semi-automatically at each individual node according to data sharing policies to ensure data sovereignty, scalability, and privacy. As a feasibility test, a natural language processing model for classification of clinical notes was deployed and tested. Discussion: The presented Health Data Space node infrastructure has proven to be practicable in a real-world implementation in a live and productive registry for heart failure. The present work was inspired by the European Health Data Space initiative and its spirit to interconnect health data silos for versatile secondary use of health data.

7.
J Epidemiol Community Health ; 78(7): 444-450, 2024 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-38688702

RESUMO

BACKGROUND: Growing up with parental alcohol use disorder (AUD) is a risk factor for psychiatric disorders. This study investigated the risk of mood disorders and of anxiety disorders in the adult children of parents with AUD, adjusted for sociodemographic factors. METHODS: Individual-level register data on the total population were linked to follow children of parents with AUD from 1973 to 2018 to assess their risk of mood disorders and of anxiety disorders. AUD, mood disorders and anxiety disorders were defined with International Statistical Classification of Diseases and Related Health Problems codes from the National Patient Register. HRs of outcomes were calculated with Cox regression. Model 1 was adjusted for the child's sex, parental education and death of a parent. Model 2 was adjusted for those factors and parental diagnosis of mood or anxiety disorder. RESULTS: Those with ≥1 parent with AUD (99 723 of 2 421 479 children) had a higher risk of mood disorder and of anxiety disorder than those whose parents did not have AUD (HR mood 2.32, 95% CI 2.26 to 2.39; HR anxiety 2.66, 95% CI 2.60 to 2.72). The risk remained elevated after adjustment for sociodemographic factors and parental psychiatric diagnosis (HR mood 1.67, 95% CI 1.63 to 1.72; HR anxiety 1.74, 95% CI 1.69 to 1.78). The highest risks were associated with AUD in both parents, followed by AUD in mothers and then in fathers. CONCLUSION: Adult children of parents with AUD have a raised risk of mood and anxiety disorders even after adjustment for sociodemographic factors and parental mood or anxiety disorder. These population-level findings can inform future policies and interventions.


Assuntos
Alcoolismo , Transtornos de Ansiedade , Transtornos do Humor , Humanos , Transtornos do Humor/epidemiologia , Transtornos de Ansiedade/epidemiologia , Filhos Adultos/psicologia , Filhos Adultos/estatística & dados numéricos , Alcoolismo/epidemiologia , Alcoolismo/psicologia , Área Sob a Curva , Suécia/epidemiologia , Masculino , Feminino , Adulto
8.
J Epidemiol Community Health ; 78(6): 380-387, 2024 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-38594065

RESUMO

BACKGROUND: There is limited evidence quantifying the risk of severe COVID-19 disease among people with opioid dependence. We examined vaccine uptake and severe disease (admission to critical care or death with COVID-19) among individuals prescribed opioid agonist therapy (OAT). METHOD: A case-control design was used to examine vaccine uptake in those prescribed OAT compared with the general population, and the association between severe disease and OAT. In both analyses, 10 controls from the general population were matched (to each OAT recipient and COVID-19 case, respectively) according to socio-demographic factors. Conditional logistic regression was used to estimate rate ratios (RR) for severe disease. RESULTS: Vaccine uptake was markedly lower in the OAT cohort (dose 1: 67%, dose 2: 53% and dose 3: 31%) compared with matched controls (76%, 72% and 57%, respectively). Those prescribed OAT within the last 5 years, compared with those not prescribed, had increased risk of severe COVID-19 (RR 3.38, 95% CI 2.75 to 4.15), particularly in the fourth wave (RR 6.58, 95% CI 4.20 to 10.32); adjustment for comorbidity and vaccine status attenuated this risk (adjusted RR (aRR) 2.43, 95% CI 1.95 to 3.02; wave 4 aRR 3.78, 95% CI 2.30 to 6.20). Increased risk was also observed for those prescribed OAT previously (>3 months ago) compared with recently (aRR 1.74, 95% CI 1.11 to 2.71). CONCLUSIONS: The widening gap in vaccine coverage for those prescribed OAT, compared with the general population, is likely to have exacerbated the risk of severe COVID-19 in this population over the pandemic. However, continued OAT use may have provided protection from severe COVID-19 among those with opioid dependence.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Transtornos Relacionados ao Uso de Opioides , SARS-CoV-2 , Humanos , COVID-19/prevenção & controle , COVID-19/epidemiologia , Masculino , Feminino , Pessoa de Meia-Idade , Estudos de Casos e Controles , Adulto , Escócia/epidemiologia , Vacinas contra COVID-19/administração & dosagem , Analgésicos Opioides/uso terapêutico , Tratamento de Substituição de Opiáceos , Índice de Gravidade de Doença
9.
Stat Methods Med Res ; 33(6): 966-980, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38592341

RESUMO

The Fellegi-Sunter model is a latent class model widely used in probabilistic linkage to identify records that belong to the same entity. Record linkage practitioners typically employ all available matching fields in the model with the premise that more fields convey greater information about the true match status and hence result in improved match performance. In the context of model-based clustering, it is well known that such a premise is incorrect and the inclusion of noisy variables could compromise the clustering. Variable selection procedures have therefore been developed to remove noisy variables. Although these procedures have the potential to improve record matching, they cannot be applied directly due to the ubiquity of the missing data in record linkage applications. In this paper, we modify the stepwise variable selection procedure proposed by Fop, Smart, and Murphy and extend it to account for missing data common in record linkage. Through simulation studies, our proposed method is shown to select the correct set of matching fields across various settings, leading to better-performing algorithms. The improved match performance is also seen in a real-world application. We therefore recommend the use of our proposed selection procedure to identify informative matching fields for probabilistic record linkage algorithms.


Assuntos
Algoritmos , Análise de Classes Latentes , Registro Médico Coordenado , Humanos , Registro Médico Coordenado/métodos , Modelos Estatísticos , Análise por Conglomerados , Simulação por Computador
10.
JAMIA Open ; 7(1): ooae010, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38425705

RESUMO

Objective: In retrospective secondary data analysis studies, researchers often seek waiver of consent from institutional Review Boards (IRB) and minimize risk by utilizing complex software. Yet, little is known about the perspectives of IRB experts on these approaches. To facilitate effective communication about risk mitigation strategies using software, we conducted two studies with IRB experts to co-create appropriate language when describing a software to IRBs. Materials and Methods: We conducted structured focus groups with IRB experts to solicit ideas on questions regarding benefits, risks, and informational needs. Based on these results, we developed a template IRB application and template responses for a generic study using privacy-enhancing software. We then conducted a three-round Delphi study to refine the template IRB application and the template responses based on expert panel feedback. To facilitate participants' deliberation, we shared the revisions and a summary of participants' feedback during each Delphi round. Results: 11 experts in two focus groups generated 13 ideas on risks, benefits, and informational needs. 17 experts participated in the Delphi study with 13 completing all rounds. Most agreed that privacy-enhancing software will minimize risk, but regardless all secondary data studies have an inherent risk of unexpected disclosures. The majority (84.6%) noted that subjects in retrospective secondary data studies experience no greater risks than the risks experienced in ordinary life in the modern digital society. Hence, all retrospective data-only studies with no contact with subjects would be minimal risk studies. Conclusion: First, we found fundamental disagreements in how some IRB experts view risks in secondary data research. Such disagreements are consequential because they can affect determination outcomes and might suggest IRBs at different institutions might come to different conclusions regarding similar study protocols. Second, the highest ranked risks and benefits of privacy-enhancing software in our study were societal rather than individual. The highest ranked benefits were facilitating more research and promoting responsible data governance practices. The highest ranked risks were risk of invalid results from systematic user error or erroneous algorithms. These societal considerations are typically more characteristic of public health ethics as opposed to the bioethical approach of research ethics, possibly reflecting the difficulty applying a bioethical approach (eg, informed consent) in secondary data studies. Finally, the development of privacy-enhancing technology for secondary data research depends on effective communication and collaboration between the privacy experts and technology developers. Privacy is a complex issue that requires a holistic approach that is best addressed through privacy-by-design principles. Privacy expert participation is important yet often neglected in this design process. This study suggests best practice strategies for engaging the privacy community through co-developing companion documents for software through participatory design to facilitate transparency and communication. In this case study, the final template IRB application and responses we released with the open-source software can be easily adapted by researchers to better communicate with their IRB when using the software. This can help increase responsible data governance practices when many software developers are not research ethics experts.

11.
BMJ Open Qual ; 13(1)2024 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-38458759

RESUMO

BACKGROUND: Appropriately documented medical records enhance coordination, patient outcomes and clinical research. OBJECTIVE: The aim of this project was to improve Wallaga University Referral Hospital's (WURH) medical record completeness rate from 53% to 80% from 1 January 2023 to 31 August 2023. METHODS: A hospital-based interventional study was conducted at WURH. The Plan-Do-Study-Act cycle was used to test change ideas. A fishbone diagram and a driver diagram were used to identify root causes and address them. Key interventions consisted of supportive supervision, developing and distributing standardised formats, orientation for staff, establishing a chart audit team and assigning data owners. RESULT: On the completion of the project, the overall implementation of inpatient medical record completeness increased from 53% to 82%. This improvement varies from department-to-department. It increased from 51% to 79%, 53% to 79%, 46% to 81% and 64% to 91% in the departments of internal medicine, paediatrics, obstetrics and gynaecology and surgery, respectively. The project brought improvements in the completeness of physician notes (84% to 100%), physician order sheet (54% to 84%), nursing care plan (26% to 69%), admission sheet (76% to 98%), discharge summary (94% to 98%), progress note (38% to 91%), medication administration (80% to 100%), appropriate attachment of documents (78% to 93%) and documentation of vital signs (50% to 100%). CONCLUSION AND RECOMMENDATION: The rate of medical record completeness was significantly improved in the study area. This was achieved through the application of multidimensional change ideas related to health professionals, supplies, health management information systems and leadership. However, in some of the parameters, the national targets were not met. Therefore, we recommend providing regular technical updates, conducting frequent chart audits and providing supportive supervision for the enhancement of medical record completeness. It is also advisable for the hospital management to work on its sustainability.


Assuntos
Prontuários Médicos , Melhoria de Qualidade , Gravidez , Feminino , Humanos , Criança , Universidades , Hospitais Universitários , Encaminhamento e Consulta
12.
Int J Popul Data Sci ; 9(1): 2181, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38476270

RESUMO

Introduction: Difficulties ascertaining migrant status in national data sources such as hospital records have limited large-scale evaluation of migrant healthcare needs in many countries, including England. Linkage of immigration data for migrants and refugees, with National Health Service (NHS) hospital care data enables research into the relationship between migration and health for a large cohort of international migrants. Objectives: We aimed to describe the linkage process and compare linkage rates between migrant sub-groups to evaluate for potential bias for data on non-EU migrants and resettled refugees linked to Hospital Episode Statistics (HES) in England. Methods: We used stepwise deterministic linkage to match records from migrants and refugees to a unique healthcare identifier indicating interaction with the NHS (linkage stage 1 to NHS Personal Demographic Services, PDS), and then to hospital records (linkage stage 2 to HES). We calculated linkage rates and compared linked and unlinked migrant characteristics for each linkage stage. Results: Of the 1,799,307 unique migrant records, 1,134,007 (63%) linked to PDS and 451,689 (25%) linked to at least one hospital record between 01/01/2005 and 23/03/2020. Individuals on work, student, or working holiday visas were less likely to link to a hospital record than those on settlement and dependent visas and refugees. Migrants from the Middle East and North Africa and South Asia were four times more likely to link to at least one hospital record, compared to those from East Asia and the Pacific. Differences in age, sex, visa type, and region of origin between linked and unlinked samples were small to moderate. Conclusion: This linked dataset represents a unique opportunity to explore healthcare use in migrants. However, lower linkage rates disproportionately affected individuals on shorter-term visas so future studies of these groups may be more biased as a result. Increasing the quality and completeness of identifiers recorded in administrative data could improve data linkage quality.


Assuntos
Medicina Estatal , Migrantes , Humanos , Emigração e Imigração , Inglaterra , Hospitais
13.
Int J Med Inform ; 185: 105387, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38428200

RESUMO

BACKGROUND: Cancer registries link a large number of electronic health records reported by medical institutions to already registered records of the matching individual and tumor. Records are automatically linked using deterministic and probabilistic approaches; machine learning is rarely used. Records that cannot be matched automatically with sufficient accuracy are typically processed manually. For application, it is important to know how well record linkage approaches match real-world records and how much manual effort is required to achieve the desired linkage quality. We study the task of linking reported records to the matching registered tumor in cancer registries. METHODS: We compare the tradeoff between linkage quality and manual effort of five machine learning methods (logistic regression, random forest, gradient boosting, neural network, and a stacked method) to a deterministic baseline. The record linkage methods are compared in a two-class setting (no-match/ match) and a three-class setting (no-match/ undecided/ match). A cancer registry collected and linked the dataset consisting of categorical variables matching 145,755 reported records with 33,289 registered tumors. RESULTS: In the two-class setting, the gradient boosting, neural network, and stacked models have higher accuracy and F1 score (accuracy: 0.968-0.978, F1 score: 0.983-0.988) than the deterministic baseline (accuracy: 0.964, F1 score: 0.980) when the same records are manually processed (0.89% of all records). In the three-class setting, these three machine learning methods can automatically process all reported records and still have higher accuracy and F1 score than the deterministic baseline. The linkage quality of the machine learning methods studied, except for the neural network, increase as the number of manually processed records increases. CONCLUSION: Machine learning methods can significantly improve linkage quality and reduce the manual effort required by medical coders to match tumor records in cancer registries compared to a deterministic baseline. Our results help cancer registries estimate how linkage quality increases as more records are manually processed.


Assuntos
Registros Eletrônicos de Saúde , Neoplasias , Humanos , Registro Médico Coordenado/métodos , Neoplasias/epidemiologia , Sistema de Registros , Bases de Dados Factuais
14.
BMC Med Res Methodol ; 24(1): 67, 2024 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-38481152

RESUMO

BACKGROUND: Advancements in linking publicly available census records with vital and administrative records have enabled novel investigations in epidemiology and social history. However, in the absence of unique identifiers, the linkage of the records may be uncertain or only be successful for a subset of the census cohort, resulting in missing data. For survival analysis, differential ascertainment of event times can impact inference on risk associations and median survival. METHODS: We modify some existing approaches that are commonly used to handle missing survival times to accommodate this imperfect linkage situation including complete case analysis, censoring, weighting, and several multiple imputation methods. We then conduct simulation studies to compare the performance of the proposed approaches in estimating the associations of a risk factor or exposure in terms of hazard ratio (HR) and median survival times in the presence of missing survival times. The effects of different missing data mechanisms and exposure-survival associations on their performance are also explored. The approaches are applied to a historic cohort of residents in Ambler, PA, established using the 1930 US census, from which only 2,440 out of 4,514 individuals (54%) had death records retrievable from publicly available data sources and death certificates. Using this cohort, we examine the effects of occupational and paraoccupational asbestos exposure on survival and disparities in mortality by race and gender. RESULTS: We show that imputation based on conditional survival results in less bias and greater efficiency relative to a complete case analysis when estimating log-hazard ratios and median survival times. When the approaches are applied to the Ambler cohort, we find a significant association between occupational exposure and mortality, particularly among black individuals and males, but not between paraoccupational exposure and mortality. DISCUSSION: This investigation illustrates the strengths and weaknesses of different imputation methods for missing survival times due to imperfect linkage of the administrative or registry data. The performance of the methods may depend on the missingness process as well as the parameter being estimated and models of interest, and such factors should be considered when choosing the methods to address the missing event times.


Assuntos
Censos , Análise de Sobrevida , Feminino , Humanos , Masculino , Causalidade , Simulação por Computador , Modelos de Riscos Proporcionais
15.
Ther Innov Regul Sci ; 58(3): 443-455, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38528279

RESUMO

Conducting clinical trials (CTs) has become increasingly costly and complex in terms of designing and operationalizing. These challenges exist in running CTs on novel therapies, particularly in oncology and rare diseases, where CTs increasingly target narrower patient groups. In this study, we describe external control arms (ECA) and other relevant tools, such as virtualization and decentralized clinical trials (DCTs), and the ability to follow the clinical trial subjects in the real world using tokenization. ECAs are typically constructed by identifying appropriate external sources of data, then by cleaning and standardizing it to create an analysis-ready data file, and finally, by matching subjects in the external data with the subjects in the CT of interest. In addition, ECA tools also include subject-level meta-analysis and simulated subjects' data for analyses. By implementing the recent advances in digital health technologies and devices, virtualization, and DCTs, realigning of CTs from site-centric designs to virtual, decentralized, and patient-centric designs can be done, which reduces the patient burden to participate in the CTs and encourages diversity. Tokenization technology allows linking the CT data with real-world data (RWD), creating more comprehensive and longitudinal outcome measures. These tools provide robust ways to enrich the CT data for informed decision-making, reduce the burden on subjects and costs of trial operations, and augment the insights gained for the CT data.


Assuntos
Ensaios Clínicos como Assunto , Desenvolvimento de Medicamentos , Humanos , Projetos de Pesquisa
16.
Health Place ; 86: 103208, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38367322

RESUMO

Air pollution increases the risk of mortality and morbidity. However, limited evidence exists on the very long-term associations between early life air pollution exposure and health, as well as on potential pathways. This study explored the relationship between fine particle (PM2.5) exposure at age 3 and limiting long-term illness (LLTI) at ages 55, 65 and 75 using data from the Scottish Longitudinal Study Birth Cohort 1936, a representative administrative cohort study. We found that early life PM2.5 exposure was associated with higher odds of LLTI in mid-to-late adulthood (OR = 1.10, 95% CI: 1.06, 1.14 per 10 µg m-3 increment) among the 2085 participants, with stronger associations among those growing up in disadvantaged families. Path analyses suggested that 15-21% of the association between early life PM2.5 concentrations and LLTI at age 65 (n = 1406) was mediated through childhood cognitive ability, educational qualifications, and adult social position. Future research should capitalise on linked administrative and health data, and explore causal mechanisms between environment and specific health conditions across the life course.


Assuntos
Poluentes Atmosféricos , Poluição do Ar , Humanos , Idoso , Adulto , Criança , Pré-Escolar , Seguimentos , Poluentes Atmosféricos/análise , Estudos de Coortes , Material Particulado/análise , Estudos Longitudinais , Exposição Ambiental/efeitos adversos , Poluição do Ar/efeitos adversos , Poluição do Ar/análise , Escócia/epidemiologia
17.
BMC Psychiatry ; 24(1): 95, 2024 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-38317111

RESUMO

BACKGROUND: Mental health disorders are common among people in prison, but their prevalence in the Scandinavian prison population remain unclear. In this multinational register study, we examined the prevalence of mental health disorders and the comorbidity of substance use disorders (SUDs) with other mental health disorders in this population. Further, we investigated how the prevalence of mental disorders at prison entry had changed in Norway, Denmark, and Sweden over the study period. METHODS: The three study cohorts included all individuals, aged 19 or older, whom had been imprisoned in Norway (2010-2019), Denmark (2011-2018), and Sweden (2010-2013). Mental disorders were defined as ICD-10 diagnoses (F-codes) registered in the national patient registers. The study prevalence was estimated based on recorded diagnoses during the entire study follow-up period in each respective country. The one-year prevalence of mental disorders was estimated for each calendar year for individuals entering prison during that year. RESULTS: The Scandinavian prison cohorts included 119 507 individuals released 191 549 times during the study period. Across all three countries a high proportion of both women (61.3%-74.4%) and men (49.6%-57.9%) had at least one mental health disorder during the observation period. The most prevalent disorders were SUDs (39.1%-44.0%), depressive disorder (8.1%-17.5%), and stress related disorder (8.8%-17.1%). Women (31.8%-41.1%) had higher levels of mental health and substance use comorbidities compared to men (20.8%-27.6%). The one-year prevalence of any mental health disorder increased over time with a 33% relative increase in Norway, 8% in Denmark, and 10% in Sweden. The proportion of individuals entering prison with a comorbid SUD and other mental disorder had also increased. CONCLUSIONS: While the incarceration rate has been decreasing during the past decade in the Scandinavian countries, an increasing proportion of people entering prison have a diagnosed mental health disorder. Our results suggest that prisons should provide adequate treatment and scale up services to accommodate the increasing proportion of people with complex health needs among incarcerated people.


Assuntos
Transtornos Mentais , Prisioneiros , Transtornos Relacionados ao Uso de Substâncias , Masculino , Humanos , Feminino , Saúde Mental , Prisões , Prevalência , Prisioneiros/psicologia , Transtornos Relacionados ao Uso de Substâncias/psicologia , Transtornos Mentais/psicologia , Comorbidade
18.
Trop Med Health ; 52(1): 17, 2024 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-38331887

RESUMO

BACKGROUND: Although the Philippines targets malaria elimination by 2030, it remains to be a disease that causes considerable morbidity in provinces that report malaria. Pregnant women residing in endemic areas are a vulnerable population, because in addition to the risk of developing severe malaria, their pregnancy is not followed through, and the outcome of their pregnancy is unknown. This study determined the utility of real-world data integrated with disease surveillance data set as real-world evidence of pregnancy and delivery outcomes in areas endemic for malaria in the Philippines. METHODS: For the period of 2015 to 2019, electronic data sets of malaria surveillance data and Ospital ng Palawan hospital admission log of pregnant women residing in the four selected barangays of Rizal, Palawan were merged using probabilistic linkage. The source data for record linkage were first and last names, birth date, and address as the mutual variable. The data used for characteristics of the pregnant women from the hospital data set were admission date, discharge date, admitting and final diagnosis and body weight on admission. From the malaria surveillance data these were date of consultation, and malaria parasite species. The Levenshtein distance formula was used for a fuzzy string-matching algorithm. Chi-square test, and Mann-Whitney U test were used to compare the means of the two data sets. RESULTS: The prevalence of pregnant women admitted to the tertiary referral hospital, Ospital ng Palawan, was estimated to be 8.34/100 overall, and 11.64/100 from the four study barangays; that of malaria during pregnancy patients was 3.45/100 and 2.64/100, respectively. There was only one true-positive matched case from 238 women from the hospital and 54 women from the surveillance data sets. The overall Levenshstein score was 97.7; for non-matched cases, the mean overall score was 36.6 (35.6-37.7). The matched case was a minor who was hospitalized for severe malaria. The outcome of her pregnancy was detected from neither data set but from village-based records. CONCLUSIONS: This proof-of-concept study demonstrated that probabilistic record linkage could match real-world data in the Philippines with further validation required. The study underscored the need for more integrated and comprehensive database to monitor disease intervention impact on pregnancy and its outcome in the Philippines.

19.
BMC Pregnancy Childbirth ; 24(1): 96, 2024 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-38297231

RESUMO

BACKGROUND: To investigate associations between interpregnancy intervals (IPIs) and adverse birth outcomes in twin pregnancies. METHODS: This retrospective cohort study of 9,867 twin pregnancies in Western Australia from 1980-2015. Relative Risks (RRs) were estimated for the interval prior to the pregnancy (IPI) as the exposure and after the pregnancy as a negative control exposure for preterm birth (< 37 weeks), early preterm birth (< 34 weeks), small for gestational age (SGA: < 10th percentile of birth weight by sex and gestational age) and low birth weight (LBW: birthweight < 2,500 g). RESULTS: Relative to IPIs of 18-23 months, IPIs of < 6 months were associated with a higher risk of early preterm birth (aRR 1.41, 95% CI 1.08-1.83) and LBW for at least one twin (aRR 1.16, 95% CI 1.06-1.28). IPIs of 6-11 months were associated with a higher risk of SGA (aRR 1.24, 95% CI 1.01-1.54) and LBW for at least one twin (aRR 1.09, 95% CI 1.01-1.19). IPIs of 60-119 months and ≥ 120 months were associated with an increased risk of preterm birth (RR 1.12, 95% CI 1.03-1.22; and (aRR 1.25, 95% CI 1.10-1.41, respectively), and LBW for at least one twin (aRR 1.17, 95% CI 1.08-1.28; and aRR 1.20, 95% CI 1.05-1.36, respectively). IPIs of ≥ 120 months were also associated with an increased risk of early preterm birth (aRR 1.42, 95% CI 1.01-2.00). After negative control analysis, IPIs ≥ 120 months remained associated with early preterm birth and LBW. CONCLUSION: Evidence for adverse associations with twin birth outcomes was strongest for long IPIs.


Assuntos
Resultado da Gravidez , Nascimento Prematuro , Gravidez , Feminino , Recém-Nascido , Humanos , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/etiologia , Estudos de Coortes , Estudos Retrospectivos , Intervalo entre Nascimentos , Peso ao Nascer , Fatores de Risco
20.
J Appl Stat ; 51(2): 197-215, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38283048

RESUMO

In this paper, we study the impact of combining profile and network data in solving record de-duplication problems. We also assess the influence of a range of prior distributions on the linkage structure, and explore the use of stochastic gradient Hamiltonian Monte Carlo methods as a faster alternative to obtain samples from the posterior distribution for network parameters. Our methodology is evaluated using the RLdata500 data, which is a popular dataset in the record linkage literature.

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