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1.
Value Health ; 25(10): 1663-1672, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36241338

RESUMO

OBJECTIVES: Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias. METHODS: The International Society for Pharmacoepidemiology (ISPE) and ISPOR-The Professional Society for Health Economics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The over-arching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. STRATEGIES TO DISSEMINATE AND FACILITATE USE: Recognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years. CONCLUSION: The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.


Assuntos
Comitês Consultivos , Relatório de Pesquisa , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Farmacoepidemiologia , Reprodutibilidade dos Testes
2.
Neuropharmacology ; 220: 109262, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-36154842

RESUMO

A role for voltage-gated calcium channels (VGCCs) in psychiatric disorders has long been postulated as part of a broader involvement of intracellular calcium signalling. However, the data were inconclusive and hard to interpret. We review three areas of research that have markedly advanced the field. First, there is now robust genomic evidence that common variants in VGCC subunit genes, notably CACNA1C which encodes the L-type calcium channel (LTCC) CaV1.2 subunit, are trans-diagnostically associated with psychiatric disorders including schizophrenia and bipolar disorder. Rare variants in these genes also contribute to the risk. Second, pharmacoepidemiological evidence supports the possibility that calcium channel blockers, which target LTCCs, might have beneficial effects on the onset or course of these disorders. This is especially true for calcium channel blockers that are brain penetrant. Third, long-range sequencing is revealing the repertoire of full-length LTCC transcript isoforms. Many novel and abundant CACNA1C isoforms have been identified in human and mouse brain, including some which are enriched compared to heart or aorta, and predicted to encode channels with differing functional and pharmacological properties. These isoforms may contribute to the molecular mechanisms of genetic association to psychiatric disorders. They may also enable development of therapeutic agents that can preferentially target brain LTCC isoforms and be of potential value for psychiatric indications.


Assuntos
Canais de Cálcio Tipo L , Transtornos Mentais , Animais , Cálcio , Bloqueadores dos Canais de Cálcio/farmacologia , Bloqueadores dos Canais de Cálcio/uso terapêutico , Canais de Cálcio Tipo L/genética , Genômica , Humanos , Transtornos Mentais/tratamento farmacológico , Transtornos Mentais/genética , Camundongos , Farmacoepidemiologia , Isoformas de Proteínas
4.
Pharmacoepidemiol Drug Saf ; 31(11): 1140-1152, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35984046

RESUMO

Transparency is increasingly promoted to instill trust in nonrandomized studies using real-world data. Graphics and data visualizations support transparency by aiding communication and understanding, and can inform study design and analysis decisions. However, other than graphical representation of a study design and flow diagrams (e.g., a Consolidated Standards of Reporting Trials [CONSORT] like diagram), specific standards on how to maximize validity and transparency with visualization are needed. This paper provides guidance on how to use visualizations throughout the life cycle of a pharmacoepidemiology study-from initial study design to final report-to facilitate rationalized and transparent decision-making about study design and implementation, and clear communication of study findings. Our intent is to help researchers align their practices with current consensus statements on transparency.


Assuntos
Farmacoepidemiologia , Projetos de Pesquisa , Consenso , Humanos , Padrões de Referência , Pesquisadores
5.
Pharmacoepidemiol Drug Saf ; 31(9): 932-943, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35729705

RESUMO

PURPOSE: Supplementing investigator-specified variables with large numbers of empirically identified features that collectively serve as 'proxies' for unspecified or unmeasured factors can often improve confounding control in studies utilizing administrative healthcare databases. Consequently, there has been a recent focus on the development of data-driven methods for high-dimensional proxy confounder adjustment in pharmacoepidemiologic research. In this paper, we survey current approaches and recent advancements for high-dimensional proxy confounder adjustment in healthcare database studies. METHODS: We discuss considerations underpinning three areas for high-dimensional proxy confounder adjustment: (1) feature generation-transforming raw data into covariates (or features) to be used for proxy adjustment; (2) covariate prioritization, selection, and adjustment; and (3) diagnostic assessment. We discuss challenges and avenues of future development within each area. RESULTS: There is a large literature on methods for high-dimensional confounder prioritization/selection, but relatively little has been written on best practices for feature generation and diagnostic assessment. Consequently, these areas have particular limitations and challenges. CONCLUSIONS: There is a growing body of evidence showing that machine-learning algorithms for high-dimensional proxy-confounder adjustment can supplement investigator-specified variables to improve confounding control compared to adjustment based on investigator-specified variables alone. However, more research is needed on best practices for feature generation and diagnostic assessment when applying methods for high-dimensional proxy confounder adjustment in pharmacoepidemiologic studies.


Assuntos
Aprendizado de Máquina , Farmacoepidemiologia , Fatores de Confusão Epidemiológicos , Bases de Dados Factuais , Atenção à Saúde , Humanos
6.
Drug Saf ; 45(7): 747-754, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35729468

RESUMO

INTRODUCTION: As patient registries are not subject to regulatory requirements on the collection of adverse events (AEs) related to medicinal products, they may not have foreseen the collection of such information on a routine basis or as part of specific data collection schemes. OBJECTIVE: The European Medicines Agency conducted a survey among registries to better understand their approach towards the collection, management and reporting of AEs related to medicines. METHOD: An online survey composed of 15 questions was distributed in May 2020 to registries listed in the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) resources database for completion by August 2020. Aggregated results are presented in this paper. RESULTS: One third of the registries completed the survey (31/85; 36.5%). Most of the respondents routinely collect information on medicines (29/31; 93.5%), out of which 65.5% (19/29) also collect data on AEs and adverse drug reactions (ADRs). Frequencies and timelines for collecting and reporting AEs/ADRs vary widely across registries, as does their level of experience in providing data to third parties for regulatory purposes. CONCLUSIONS: The low response rate may indicate little interest in this topic or that registries were not originally developed for routine data collection on AEs/ADRs and, ultimately, monitoring of the safety of medicines. Results indicate that clear guidance on the collection and use of real-world data in regulatory frameworks and strengthened collaboration between registry holders, academia, regulators and medicines developers are needed to achieve comprehensive and high levels of quality of safety data captured by registries to support regulatory decision making. These will hopefully be enabled by the European Medicines Regulatory Network strategy to 2025.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Farmacoepidemiologia , Sistema de Registros , Inquéritos e Questionários
7.
Pharmacoepidemiol Drug Saf ; 31(8): 817-826, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35621007

RESUMO

In this review paper, I outline the principles of the cohort as a sampling frame and provide a basic introduction to the cohort study design and the case-control study design, two of the most important designs in the pharmacoepidemiologist's toolbox. Further, I discuss when to prefer one design over the other. The paper is intended as a primer for people new to the field of pharmacoepidemiology and contains a range of suggestions for additional reading regarding the study designs and related epidemiological topics.


Assuntos
Farmacoepidemiologia , Projetos de Pesquisa , Estudos de Casos e Controles , Estudos de Coortes , Humanos
8.
Drug Saf ; 45(5): 493-510, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35579813

RESUMO

Increasing availability of electronic health databases capturing real-world experiences with medical products has garnered much interest in their use for pharmacoepidemiologic and pharmacovigilance studies. The traditional practice of having numerous groups use single databases to accomplish similar tasks and address common questions about medical products can be made more efficient through well-coordinated multi-database studies, greatly facilitated through distributed data network (DDN) architectures. Access to larger amounts of electronic health data within DDNs has created a growing interest in using data-adaptive machine learning (ML) techniques that can automatically model complex associations in high-dimensional data with minimal human guidance. However, the siloed storage and diverse nature of the databases in DDNs create unique challenges for using ML. In this paper, we discuss opportunities, challenges, and considerations for applying ML in DDNs for pharmacoepidemiologic and pharmacovigilance studies. We first discuss major types of activities performed by DDNs and how ML may be used. Next, we discuss practical data-related factors influencing how DDNs work in practice. We then combine these discussions and jointly consider how opportunities for ML are affected by practical data-related factors for DDNs, leading to several challenges. We present different approaches for addressing these challenges and highlight efforts that real-world DDNs have taken or are currently taking to help mitigate them. Despite these challenges, the time is ripe for the emerging interest to use ML in DDNs, and the utility of these data-adaptive modeling techniques in pharmacoepidemiologic and pharmacovigilance studies will likely continue to increase in the coming years.


Assuntos
Aprendizado de Máquina , Farmacovigilância , Bases de Dados Factuais , Humanos , Farmacoepidemiologia
11.
J Clin Epidemiol ; 148: 74-80, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35447357

RESUMO

OBJECTIVES: To review comparative effectiveness research (CER) using physician's prescribing preference as an instrumental variable (PPP IV) in pharmacoepidemiology and to review methodological studies that use simulation to evaluate the performance of PPP IV in CER. STUDY DESIGN AND SETTING: We conducted a review of CER using PPP IV and studies evaluating the use of PPP IV by using simulation methods. We searched Ovid, PubMed, and Google Scholar databases from 2005 to 2020. RESULTS: We identified six simulation studies and 18 CER studies. The simulation studies explored the most suitable ways for using PPP IV in different settings (outcome types, sample size, and the prevalence of outcomes) which can be useful guidance for using PPP IV in CER. The CER studies identified show heterogeneity in terms of validation assumptions, estimation methods, and sample size. Not all applied studies used the methodological insights from the simulation studies. However, they all concluded that PPP is a valid IV. CONCLUSION: Future CER should consider a range of methodological issues to improve the validity of findings when using PPP IV. Specifically, studies should consider the impact of a different choice of statistical methods, forms of proxy for measuring preference, time-varying exposures, and the type of outcome.


Assuntos
Pesquisa Comparativa da Efetividade , Médicos , Humanos , Padrões de Prática Médica , Farmacoepidemiologia/métodos , Simulação por Computador
12.
Artigo em Inglês | MEDLINE | ID: mdl-35270655

RESUMO

(1) Background: Precarious patients are more difficult to care for due to low literacy rates and poor adherence to treatment and hospitalization. These difficulties have detrimental effects on general practitioners (GPs), deteriorating medical communication, advice, diagnoses, and drug prescriptions. To better understand how precariousness affects primary care, we tested whether, among GPs, exposure to high precariousness prevalence more severely impacts drug prescriptions to precarious and non-precarious populations compared to low precariousness prevalence. Materials and methods: This pharmaco-epidemiological study, using linear regression analyses, compared the defined daily dose of 20 drugs prescribed by GPs to precarious and non-precarious patients in four French regions with low and high precariousness prevalence in 2015. (2) Findings: Exposure to high precariousness prevalence significantly impacted the prescriptions of nine medications to precarious patients and two medications to non-precarious patients, and distributed into three interaction patterns. (3) Interpretation: The selective over-prescription of drugs with easy intake modalities to precarious patients probably reflects GPs' attempts to compensate for poor patient compliance. In contrast, the under-prescription of drugs targeting fungal infections in precarious populations and diabetes and cardiovascular diseases in non-precarious populations was seemingly due to a breakdown of empathy and professional exhaustion, causing medical neglect.


Assuntos
Clínicos Gerais , Prescrições de Medicamentos , Humanos , Farmacoepidemiologia , Prevalência , Estudos Retrospectivos
13.
Rev. esp. salud pública ; 96: e202203033-e202203033, Mar. 2022. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-211288

RESUMO

Fundamentos: El trastorno por déficit de atención e hiperactividad (TDAH) es un trastorno común del neurodesarrollo infantil que se caracteriza fundamentalmente por tres síntomas a nivel central: falta de atención, hiperactividad e impulsividad. Se trata de uno de los trastornos psiquiátricos infantiles más comúnmente diagnosticados, con una prevalencia a nivel mundial que oscila entre el 3% y el 5%, y entre el 6% y el 7% en la población española. El objetivo del estudio es analizar la tendencia del consumo de los fármacos utilizados para el tratamiento del TDAH entre los años 2010-2019 en Castilla y León. Métodos: Estudio epidemiológico de registro de todas las dispensaciones realizadas en las oficinas de farmacia de Castilla y León entre el año 2010 y 2019 a pacientes menores de 19 años, de los principios activos N06BA04 (metilfenidato), N06BA09 (atomoxetina), N06BA12 (lisdexanfetamina), N06BA07 (modafinilo) y C02AC02 (guanfacina). Los datos de utilización de medicamentos se obtuvieron a partir del sistema de información para la prestación farmacéutica de Castilla y León, CONCYLIA. Se calcularon frecuencias en valores absolutos y los porcentajes correspondientes. Se utilizó el test-t de Student para estimar diferencias entre variables continuas y el test Chi-cuadrado de Pearson para las categóricas, mientras que la tendencia de consumo se analizó mediante el test de Cochran-Armitage. Resultados: Se dispensaron anualmente los medicamentos para el TDAH al 1,77% de la población, siendo el consumo más de tres veces mayor en niños que en niñas (2,69% vs 0,81%; p=0,001). La franja de edad donde se observó el mayor pico de consumo fue de los 10 a 14 años con un 3,42%. El metilfenidato fue el medicamento consumido por un mayor porcentaje de la población (2,44%) seguido de la lisdexanfetamina (0,37%).(AU)


Background: Attention deficit hyperactivity disorder (ADHD) is a common childhood neurodevelopmental disorder characterised primarily by three core symptoms: inattention, hyperactivity and impulsivity. It is one of the most commonly diagnosed childhood psychiatric disorders, with a worldwide prevalence of between 3% and 5%, and between 6% and 7% in the Spanish population. The aim of the study is to analyse the trend in the consumption of drugs used for the treatment of ADHD between 2010-2019 in Castilla y León. Methods: Epidemiological registry study of all dispensing in pharmacies in Castilla y León between 2010 and 2019 to patients under 19 years of age, of active substance N06BA04 (methylphenidate), N06BA09 (atomoxetine), N06BA12 (lisdexamfetamine), N06BA07 (modafinil) and C02AC02 (guanfacine). Data on drug use were obtained from the information system for the pharmaceutical provision of Castilla y León, CONCYLIA. Frequencies in absolute values and the corresponding percentages were calculated. Student’s t-test was used to estimate differences between continuous variables and Pearson’s Chi-square test for categorical variables, while the trend in consumption was analysed using the CochranArmitage test. Results: ADHD medication was dispensed annually to 1.77% of the population, with consumption beingmore than three times higher in boys than in girls (2.69% vs 0.81%; p=0.001). The age group with the highest peak use was 10-14 years with 3.42%. Methylphenidate was the drug used by the highest percentage of the population (2.44%) followed by lisdexamfetamine (0.37%). Conclusions: Approximately 2 out of every 100 people aged 0-19 years were treated with some ADHD medication, mainly methylphenidate, in Castilla y León between 2010 and 2019. (AU)


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Farmacoepidemiologia , Transtorno do Deficit de Atenção com Hiperatividade , Comorbidade , Metilfenidato , Cloridrato de Atomoxetina , Dimesilato de Lisdexanfetamina , Modafinila , Guanfacina , Prevalência , Saúde Pública , Promoção da Saúde , Espanha , Epidemiologia Descritiva , Estudos Retrospectivos
14.
Basic Clin Pharmacol Toxicol ; 130(6): 632-643, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35357769

RESUMO

The definition of a new case is a vital step in incidence studies in both epidemiology and pharmacoepidemiology, although with significant differences in methodology between the fields. We define and apply a framework for two different types of new cases of drug use, first-ever and recurrent, and show how the associated misclassifications related to length of run-in period can be expressed by the positive predictive value (PPV). In the study, we consider individual-level dispensations of statins 2006-2019 for 1,017,058 individuals with at least one dispensation in 2019 in Sweden. The incidence proportion for statins for both sexes of all ages in Sweden 2019 varied from 17.4/1000 with a run-in of 8 months, 9.45/1000 with 5 years and 8.4/1000 with 10 years. The PPV was 49% with 8 months and 89% for 5 years using 10 years as gold standard. We conclude that the interpretation of incidence and thus the selection of an appropriate run-in period, in pharmacoepidemiology, depends on whether first-ever use, recurrent treatment or both together (new cases) is the focus of the research question studied. At least five different misclassifications can be introduced depending on how incidence is defined.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases , Farmacoepidemiologia , Estudos de Coortes , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Incidência , Lactente , Masculino , Farmacoepidemiologia/métodos , Valor Preditivo dos Testes
15.
Clin Pharmacol Ther ; 112(5): 990-999, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35170021

RESUMO

As the scientific research community along with healthcare professionals and decision makers around the world fight tirelessly against the coronavirus disease 2019 (COVID-19) pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly under-represent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: (1) study population identification based on exposure status; (2) ascertainment of outcomes; (3) common biases and potential solutions; and (iv) data operational challenges specific to COVID-19 CER using EHRs. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This paper is endorsed by the International Society for Pharmacoepidemiology (ISPE).


Assuntos
COVID-19 , Pesquisa Comparativa da Efetividade , Humanos , Pesquisa Comparativa da Efetividade/métodos , Registros Eletrônicos de Saúde , Farmacoepidemiologia , Pandemias/prevenção & controle
16.
Therapie ; 77(2): 229-240, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34973825

RESUMO

Since the early 2000s, the arrival of the so-called targeted therapies and immunotherapies have prolonged survival rates in many cancers. In parallel, post-marketing surveillance of anticancer drugs through pharmacoepidemiology has gradually developed. This paper provides (i) a detailed argumentation of the foundations for pharmacoepidemiology of anticancer drugs, (ii) an overview of pharmacoepidemiological studies currently available in this field, and (iii) some perspectives to improve pharmacoepidemiology for oncology practice. First of all, according to the existing literature, the development of pharmacoepidemiological studies for the clinical evaluation of anticancer drugs appears particularly justified based on common limitations of clinical trials in oncology regarding essential methodological principles such as adequate control groups, randomisation or double blinding. Many descriptive field cohort studies have investigated together treatment patterns, effectiveness, and safety to compare results from clinical trials with those of everyday practice. The utilisation of anticancer drugs has also been extensively described through cross-sectional or cohort studies by often using medico-administrative or medical databases. Such studies are useful to quantify and characterise use over time in the population, including clinically unvalidated use, and to evaluate adherence and persistence to increasingly available oral anticancer drugs. Despite their importance to increase knowledge, comparative effectiveness or safety studies remain uncommon. In a context of rapidly emerging therapies and personalised treatments, this may be due to methodological challenges especially related to the choice of a comparator or the consideration of confounding by indication. In the future, efforts must be pursued to provide real-time access to high-quality, large-scale clinical, biological and treatment data, and to improve record-linkage between hospital and outpatient databases. More research is also needed to better evaluate all medications, not only anticancer, as part of an overall cancer care pathway and to bring the evaluation of anticancer drugs closer to patients and society (social pharmacology).


Assuntos
Antineoplásicos , Neoplasias , Antineoplásicos/uso terapêutico , Estudos Transversais , Bases de Dados Factuais , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Farmacoepidemiologia/métodos
17.
Pharmacoepidemiol Drug Saf ; 31(3): 261-269, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35019190

RESUMO

Confounding by indication poses a significant threat to the validity of nonexperimental studies assessing effectiveness and safety of medical interventions. While no different from other forms of confounding in theory, confounding by indication often requires specific methods to address the bias it creates in addition to common epidemiological adjustment or restriction methods. Clinical indication influencing treatment prescription is patient-specific and complex, making it challenging to measure within nonexperimental research. Restriction of the study population to patients with the indication for treatment would effectively mitigate confounding by indication and bring about comparability between exposure and comparator populations with respect to probability of the exposure. Active comparators are often an effective practical solution to restrict the study population in this manner when indication cannot be measured accurately. This article discusses various forms of confounding by indication, the utility of active comparators for nonexperimental studies of treatment effects, and the active comparator, new user (ACNU) study design to implicitly condition on indication. Considerations for selecting active comparators and conducting an ACNU study design are discussed to enable increased adoption of these methods, improve quality of nonexperimental studies, and ultimately strengthen our evidence base for intended and unintended treatment effects in relevant target populations.


Assuntos
Farmacoepidemiologia , Projetos de Pesquisa , Viés , Humanos , Farmacoepidemiologia/métodos
18.
Acta sci., Health sci ; 44: e56764, Jan. 14, 2022.
Artigo em Inglês | LILACS | ID: biblio-1367790

RESUMO

The aim of this study was to investigate possible factors related to antiretroviral therapy (ART) that contribute to the understanding of the highest rate of Aids detection on the coast of the state of Paraná, a port region identified administratively as the 1stRegional Health Division (1stHD) in the state of Paraná. Data on the sociodemographic profile of the population undergoing antiretroviral treatment (ART), medication changes, dropout of therapy, proportion of the population undergoing treatment and viral load were obtained through computerized systems. Between July 1, 2018 and June 31, 2019, 1,393 people were on ART in the 1stRS. Of these, 57.6% were male. During this period, 110 people started ART with a predominance of the age group between 30 and 39 years old. ART was switched for169 people and 211 patient dropouts were detected. The proportion of people diagnosed with HIV without treatment (gap) is still high, however 92.7% people on ART have suppressed viral load. It can be concluded that the lower educational level of the population undergoing treatment, the late diagnosis of those infected and the treatment gapprobably contribute to the highest rate of Aids detection in the 1stRS.


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Síndrome de Imunodeficiência Adquirida/epidemiologia , Farmacoepidemiologia/métodos , Antirretrovirais/uso terapêutico , Fatores Sociodemográficos , População , Síndrome de Imunodeficiência Adquirida/diagnóstico , Síndrome de Imunodeficiência Adquirida/terapia , HIV/patogenicidade , Carga Viral , Atenção à Saúde
19.
Am J Epidemiol ; 191(4): 711-723, 2022 03 24.
Artigo em Inglês | MEDLINE | ID: mdl-35015823

RESUMO

Pharmacoepidemiologic studies are increasingly conducted within linked databases, often to obtain richer confounder data. However, the potential for selection bias is frequently overlooked when linked data is available only for a subset of patients. We highlight the importance of accounting for potential selection bias by evaluating the association between antipsychotics and type 2 diabetes in youths within a claims database linked to a smaller laboratory database. We used inverse probability of treatment weights (IPTW) to control for confounding. In analyses restricted to the linked cohorts, we applied inverse probability of selection weights (IPSW) to create a population representative of the full cohort. We used pooled logistic regression weighted by IPTW only or IPTW and IPSW to estimate treatment effects. Metabolic conditions were more prevalent in linked cohorts compared with the full cohort. Within the full cohort, the confounding-adjusted hazard ratio was 2.26 (95% CI: 2.07, 2.49) comparing initiation of antipsychotics with initiation of control medications. Within the linked cohorts, a different magnitude of association was obtained without adjustment for selection, whereas applying IPSW resulted in point estimates similar to the full cohort's (e.g., an adjusted hazard ratio of 1.63 became 2.12). Linked database studies may generate biased estimates without proper adjustment for potential selection bias.


Assuntos
Diabetes Mellitus Tipo 2 , Adolescente , Viés , Estudos de Coortes , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , Farmacoepidemiologia , Viés de Seleção
20.
Pharmacoepidemiol Drug Saf ; 31(4): 411-423, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35092316

RESUMO

PURPOSE: The high-dimensional propensity score (HDPS) is a semi-automated procedure for confounder identification, prioritisation and adjustment in large healthcare databases that requires investigators to specify data dimensions, prioritisation strategy and tuning parameters. In practice, reporting of these decisions is inconsistent and this can undermine the transparency, and reproducibility of results obtained. We illustrate reporting tools, graphical displays and sensitivity analyses to increase transparency and facilitate evaluation of the robustness of analyses involving HDPS. METHODS: Using a study from the UK Clinical Practice Research Datalink that implemented HDPS we demonstrate the application of the proposed recommendations. RESULTS: We identify seven considerations surrounding the implementation of HDPS, such as the identification of data dimensions, method for code prioritisation and number of variables selected. Graphical diagnostic tools include assessing the balance of key confounders before and after adjusting for empirically selected HDPS covariates and the identification of potentially influential covariates. Sensitivity analyses include varying the number of covariates selected and assessing the impact of covariates behaving empirically as instrumental variables. In our example, results were robust to both the number of covariates selected and the inclusion of potentially influential covariates. Furthermore, our HDPS models achieved good balance in key confounders. CONCLUSIONS: The data-adaptive approach of HDPS and the resulting benefits have led to its popularity as a method for confounder adjustment in pharmacoepidemiological studies. Reporting of HDPS analyses in practice may be improved by the considerations and tools proposed here to increase the transparency and reproducibility of study results.


Assuntos
Algoritmos , Farmacoepidemiologia , Fatores de Confusão Epidemiológicos , Humanos , Pontuação de Propensão , Reprodutibilidade dos Testes
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