scholarly journals Detection of adverse drug events in e-prescribing and administrative health data: a validation study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bettina Habib ◽  
Robyn Tamblyn ◽  
Nadyne Girard ◽  
Tewodros Eguale ◽  
Allen Huang

Abstract Background Administrative health data are increasingly used to detect adverse drug events (ADEs). However, the few studies evaluating diagnostic codes for ADE detection demonstrated low sensitivity, likely due to narrow code sets, physician under-recognition of ADEs, and underreporting in administrative data. The objective of this study was to determine if combining an expanded ICD code set in administrative data with e-prescribing data improves ADE detection. Methods We conducted a prospective cohort study among patients newly prescribed antidepressant or antihypertensive medication in primary care and followed for 2 months. Gold standard ADEs were defined as patient-reported symptoms adjudicated as medication-related by a clinical expert. Potential ADEs in administrative data were defined as physician, ED, or hospital visits during follow-up for known adverse effects of the study medication, as identified by ICD codes. Potential ADEs in e-prescribing data were defined as study drug discontinuations or dose changes made during follow-up for safety or effectiveness reasons. Results Of 688 study participants, 445 (64.7%) were female and mean age was 64.2 (SD 13.9). The study drug for 386 (56.1%) patients was an antihypertensive, and for 302 (43.9%) an antidepressant. Using the gold standard definition, 114 (16.6%) patients experienced an ADE, with 40 (10.4%) among antihypertensive users and 74 (24.5%) among antidepressant users. The sensitivity of the expanded ICD code set was 7.0%, of e-prescribing data 9.7%, and of the two combined 14.0%. Specificities were high (86.0–95.0%). The sensitivity of the combined approach increased to 25.8% when analysis was restricted to the 27% of patients who indicated having reported symptoms to a physician. Conclusion Combining an expanded diagnostic code set with e-prescribing data improves ADE detection. As few patients report symptoms to their physician, higher detection rates may be achieved by collecting patient-reported outcomes via emerging digital technologies such as patient portals and mHealth applications.

Author(s):  
Amanda Leanne Butler ◽  
Mark Smith ◽  
Wayne Jones ◽  
Carol E Adair ◽  
Simone Vigod ◽  
...  

BackgroundCanada has a publicly-funded universal healthcare system with information systems managed by 13 different provinces and territories. This context creates inconsistencies in data collection and challenges for research or surveillance conducted at the national or multi-jurisdictional level. ObjectiveUsing a recent Canadian research project as a case study, we document the strengths and challenges of using administrative health data in a multi-jurisdictional context. We discuss the implications of using different health information systems and the solutions we adopted to deal with variations. Our goal is to contribute to better understanding of these challenges and the development of a more integrated and harmonized approach to conducting multi-jurisdictional research using administrative data. Context and ModelUsing data from five separate provincial healthcare data systems, we sought to create and report on a set of provincially-comparable mental health and addiction services performance indicators. In this paper, we document the research process, challenges, and solutions. Finally, we conclude by making recommendations for investment in national infrastructure that could help cut costs, broaden scope, and increase use of administrative health data that exists in Canada. ConclusionCanada has an incredible wealth of administrative data that resides in 13 territorial and provincial government systems. Navigating access and improving comparability across these systems has been an ongoing challenge for the past 20 years, but progress is being made. We believe that with some investment, a more harmonized and integrated information network could be developed that supports a broad range of surveillance and research activities with strong policy and program implications.


Author(s):  
Alan Katz ◽  
Jennifer Enns ◽  
Sabrina T Wong ◽  
Tyler Williamson ◽  
Alexander Singer ◽  
...  

Over the last 30 years, public investments in Canada and many other countries have created clinical and administrative health data repositories to support research on health and social services, population health and health policy. However, there is limited capacity to share and use data across jurisdictional boundaries, in part because of inefficient and cumbersome procedures to access these data and gain approval for their use in research. A lack of harmonization among variables and indicators makes it difficult to compare research among jurisdictions. These challenges affect the quality, scope, and impact of work that could be done. The purpose of this paper is to compare and contrast the data access procedures in three Canadian jurisdictions (Manitoba, Alberta and British Columbia), and to describe how we addressed the challenges presented by differences in data governance and architecture in a Canadian cross-jurisdictional research study. We characterize common stages in gaining access to administrative data among jurisdictions, including obtaining ethics approval, applying for data access from data custodians, and ensuring the extracted data is released to accredited individuals in secure data environments. We identify advantages of Manitoba’s flexible ‘stewardship’ model over the more restrictive ‘custodianship’ model in British Columbia, and highlight the importance of communication between analysts in each jurisdiction to compensate for differences in coding variables and poor quality data. Researchers and system planners must have access to and be able to make effective use of administrative health data to ensure that Canadians continue to have access to high-quality health care and benefit from effective health policies. The considerable benefits of collaborative population-based research that spans jurisdictional borders have been recognized by the Canadian Institutes for Health Research in their recent call for the creation of a National Data Platform to resolve many of the issues in harmonization and validation of administrative data elements.


Author(s):  
Jennifer Brooks ◽  
Evdokia Anagnostou ◽  
Farah Rahman ◽  
Karen Tu ◽  
Lavnaya Uruthiramoorthy ◽  
...  

IntroductionAutism Spectrum Disorder (ASD) is a neurodevelopmental disorder (NDD) that presents with a high degree of heterogeneity (e.g., co-occurrence of other NDDs and other co-morbid conditions), contributing to differential health system needs. Genetics are known to play an important role in ASD and may be associated with different disease trajectories. Objectives and ApproachIn this proof of principle project, our objective is to link >2,200 children with a confirmed diagnosis of a NDD from the Province of Ontario Neurodevelopmental (POND) Study to administrative health data and electronic medical record (EMR) data in order to identify subgroups of ASD with unique health system trajectories. POND includes detailed phenotype and whole genome sequencing (WGS) data. Identified subgroups will be characterized based on clinical phenotype and genetics. To meet this goal, consideration of WGS-specific privacy and data issues is needed to implement processes which are above and beyond traditional requirements for analyzing individual-level administrative health data. ResultsLinkage of WGS data with administrative health data is an emerging area of research. As such it has presented a number of initial challenges for our study of ASD. Privacy concerns surrounding the use of WGS data and rare-variant analysis are of particular importance. Practical issues required the need for analysts with expertise in administrative data, EMR data and genetic analyses, and specialized software and sufficient processing power to analyze WGS data. Transdisciplinary discussions of the scope and significance of research questions addressed through this linkage were crucial. The identification of genetic determinants of phenotypes and trajectories in ASD could support targeted early interventions; EMR linkage may inform algorithms to identify ASD in broader populations. These approaches could improve both patient outcome and family experience. Conclusion/ImplicationsAs the cost of genetic sequencing decreases, WGS data will become part of the routine clinical management of patients. Linkage of WGS, EMR and administrative data has tremendous potential that has largely not been realized; including population-level ASD research to improve our ability to predict long-term outcomes associated with ASD.


Author(s):  
Fatima Rodriguez ◽  
Leo Ungar ◽  
Anne Hellkamp ◽  
Richard C Becker ◽  
Scott D Berkowitz ◽  
...  

Background: Patient-reported outcomes and satisfaction are important in both trials and clinical practice and may be associated with treatment adherence. Methods: ROCKET-AF was a randomized, double-blind trial of rivaroxaban versus warfarin for prevention of thromboembolism in patients with atrial fibrillation. In a substudy, we compared treatment satisfaction scores: Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). Patient-driven discontinuation included stopping study drugs due to withdrawal of consent, non-compliance, or loss to follow-up. Rates of discontinuation were calculated for participants above and below the median scores for each scale. Results: Of 14,264 patients in ROCKET AF, 1,181 (8.3%; median age 75 years; 34% women) patients completed both the ACTS and TSQM II questionnaires 4 weeks after starting the study drug. Over a median follow-up of 1.6 years, 450 premature study drug discontinuations occurred, 116 (26%) patient-driven. Patients less satisfied with treatment by the ACTS Benefits and Burdens and TSQM II scales had higher rates of study drug discontinuation ( Table ). Conclusions: Patient-reported satisfaction was lower in patients with study drug discontinuation, suggesting that collecting patient-reported outcomes early in clinical trials may guide interventions that improve adherence and clinical outcomes.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e035763
Author(s):  
Daniel Schwarzkopf ◽  
Carolin Fleischmann-Struzek ◽  
Peter Schlattmann ◽  
Heike Dorow ◽  
Dominique Ouart ◽  
...  

IntroductionSepsis is a major cause of preventable deaths in hospitals. This study aims to investigate if sepsis incidence and quality of care can be assessed using inpatient administrative health data (IAHD).Methods and analysisDesign: Retrospective observational validation study using routine data to assess the diagnostic accuracy of sepsis coding in IAHD regarding sepsis diagnosis based on medical record review. Procedure: A stratified sample of 10 000 patients with an age ≥15 years treated in between 2015 and 2017 in 10 German hospitals is investigated. All available information of medical records is screened by trained physicians to identify true sepsis cases (‘gold standard’) both according to current (‘sepsis-1’) definitions and new (‘sepsis-3’) definitions. Data from medical records are linked to IAHD on patient level using a pseudonym. Analyses: Proportions of cases with sepsis according to sepsis-1 and sepsis-3 definitions are calculated and compared with estimates from coding of sepsis in IAHD. Predictive accuracy (sensitivity, specificity) of different coding abstraction strategies regarding the gold standard is estimated. Predictive accuracy of mortality risk factors obtained from IAHD regarding the respective risk factors obtained from medical records is calculated. An IAHD-based risk model for hospital mortality is compared with a record-based risk model regarding model-fit and predicted risk of death. Analyses adjust for sampling weights. The obtained estimates of sensitivity and specificity for sepsis coding in IAHD are used to estimate adjusted incidence proportions of sepsis based on German national IAHD.Ethics and disseminationThe study has been approved by the ethics commission of the Jena University Hospital (No. 2018-1065-Daten). The results of the study will be discussed in an expert panel to write a memorandum on improving the utility of IAHD for epidemiological surveillance and quality management of sepsis care.Trial registration numberDRKS00017775; Pre-results.


Author(s):  
Mohammad Chowdhury ◽  
Tanvir Turin ◽  
Alex Leung ◽  
Maeve O’Beirne ◽  
Khokan Sikdar ◽  
...  

IntroductionHypertension is a common medical condition, affecting 1 in 5 Canadians, and is a major risk factor for heart attack, stroke, and kidney disease. Predicting the risk of developing incident hypertension may help to inform targeted preventive strategies. Objectives and ApproachIdentification of major risk factors and incorporation into a multivariable model for risk stratification may help to identify individuals who are at highest risk for developing incident hypertension and would potentially benefit most from intervention. The goal of the proposed research is to develop a robust hypertension prediction model for the general population using the Alberta Tomorrow Project (ATP) cohort data linked with Alberta’s administrative health data. ATP is Alberta's largest population health cohort, contains baseline data on socio-demographic characteristic, personal and family history of disease, medication use, lifestyle and health behavior, environmental exposures, physical measures and bio samples. ResultsAlberta’s administrative health data additionally provides information on health care utilization, enrollment, drugs, physician services, and hospital services. A prediction model for hypertension will be developed using logistic regression where information on candidate variables for the model will be gathered from ATP data and outcome (incident hypertension) will be ascertained from administrative health data (physicians/practitioner claim data and hospital discharge abstract data). Lacking follow-up information in current ATP data has laid the foundation of linking the two data sources through an anonymous unique person identifier (e.g. PHN) that will eventually provide follow-up information on ATP participants who are free of hypertension at baseline developed the disease as well as information on other potential variables. Conclusion/ImplicationsThe proposed prediction model will help to identify individuals at highest risk for developing hypertension and those who may benefit most from targeted healthy behavioral interventions and/or treatment. Such identification of high risk people may help prevent hypertension as well as the continuing costly cycle of managing hypertension and its complications.


Author(s):  
Jamie C Brehaut ◽  
Anne Guèvremont ◽  
Rubab G Arim ◽  
Rochelle E Garner ◽  
Anton R Miller ◽  
...  

IntroductionCaregivers of children with health problems experience poorer health than the caregivers of healthy children. To date, population-based studies on this issue have primarily used survey data. ObjectivesWe demonstrate that administrative health data may be used to study these issues, and explore how non-categorical indicators of child health in administrative data can enable population-level study of caregiver health. MethodsDyads from Population Data British Columbia (BC) databases, encompassing nearly all mothers in BC with children aged 6-10 years in 2006, were grouped using a non-categorical definition based on diagnoses and service use. Regression models examined whether four maternal health outcomes varied according to indicators of child health. Results162,847 mother-child dyads were grouped according to the following indicators: Child High Service Use (18%) vs. Not (82%), Diagnosis of Major and/or Chronic Condition (12%) vs. Not (88%), and Both High Service Use and Diagnosis (5%) vs. Neither (75%). For all maternal health and service use outcomes (number of physician visits, chronic condition, mood or anxiety disorder, hospitalization), differences were demonstrated by child health indicators. ConclusionsMothers of children with health problems had poorer health themselves, as indicated by administrative data groupings. This work not only demonstrates the research potential of using routinely collected health administrative data to study caregiver and child health, but also the importance of addressing maternal health when treating children with health problems. KeywordsPopulation data, linked data, case-mix, children with special health care needs


Author(s):  
Amanda Butler ◽  
Mark Smith ◽  
Wayne Jones ◽  
Carol Adair ◽  
Simone Vigod ◽  
...  

IntroductionCanada has a publicly-funded universal health care system with information systems managed by 13 provinces and territories. This context creates inconsistencies in data collection and challenges for epidemiological research conducted at the national or multi-jurisdictional level. Objectives and ApproachUsing a recent five-province research project as a case study (BC, AB, MB, ON, QC), we will discuss the strengths and challenges of using Canadian administrative health data in a multi-jurisdictional context. Our goal is to contribute to a better understanding of these challenges and the development of a more integrated and harmonized approach to conducting multi-jurisdictional research. ResultsMulti-jurisdictional data work is feasible but requires detailed coordination and extensive cooperation from all involved. There were noteable variations across provinces in this multi-province study. For example, time required to access the data varied greatly across the five provinces (from 4 to 9 months), and thus there were sequencing challenges, with some provinces being well into the analysis stage while others were still waiting for data. Access to human resources varied across provinces and in some cases led to delays in data abstraction. Cost of data (or analytic support) also varied across provinces, from $12,000 – $15,000. Critical to the success of the project was a coordinating group with expertise in both administrative health data and cross-provincial project coordination. Conclusion/ImplicationsThis project demonstrated the value of comparable data infrastructure with equitable access policies. Many of the disadvantages to multi-province projects using health care administrative data, such as potential coding errors and inconsistencies, can be managed by developing national standards and protocols, and tools that are shared for data cleaning and validation.


2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Beth T. Poitras ◽  
Rebecca S. Payne ◽  
Nicholas D. Seliga

ObjectiveDiscuss the power of utilizing DOD clinical ancillary services data for infectious disease surveillance, the steps used to mitigate pitfalls which may occur during the surveillance process, and the potential of adapting this data for surveillance of emerging infectious diseases.IntroductionMilitary service members and their families work and live around the world where both endemic and emerging infectious diseases are common. Timely infectious disease surveillance helps to inform medical and policy decisions which ensure mission readiness and beneficiary health. The EpiData Center (EDC) at the Navy and Marine Corps Public Health Center has performed public health surveillance, including routine infectious disease monitoring among service members, their families, and others eligible for military medical benefits for the Department of the Navy (DON) and Department of Defense (DOD) since 2005.The EDC stores and maintains 15 databases totaling over 20 terabytes of health and administrative data. These include administrative data from outpatient encounters and inpatient admissions, Health Level-7 (HL7) formatted ancillary services data, and medical event reports. These data provide the potential for robust surveillance methodologies to monitor diseases of interest and identify trends and outbreaks. The primary intent and design of these data sources is not for disease surveillance, but rather for administrative and billing purposes. However, due to the availability of this data, it is routinely used by academic organizations, private industry, health systems, and government organizations to conduct health surveillance and research. Ancillary services data in particular can be very powerful for near-real time infectious disease surveillance in the DOD as the aggregated data is available within 1 to 2 days after processing. The EDC has demonstrated the value of using laboratory data for surveillance through outbreak detection and longitudinal health trends for specific diseases among select populations.The fact that this data is not designed for surveillance does present several pitfalls in regards to analysis, from issues ranging from free text interpretation to changing testing practices. These pitfalls can be mitigated through standardized processes and detailed quality assurance testing. The EDC has harnessed the power of available administrative health data to improve health outcomes and influence policy among military beneficiaries.MethodsThe EDC has established and validated methods for using and interpreting ancillary services data. Key steps involved in the process for infectious disease surveillance include:● Reviewing diagnostic criteria;● Defining relevant search terms and test types;-● Consulting clinicians for technical input when needed;● Developing algorithms using retrospective data;● Developing quality checks;● Automating the process to reduce daily workload;● Documenting processes and methods.● Variables essential to interpretation within ancillary services records are not standardized across the DOD.Several pitfalls can occur during the surveillance process due to complexities related to free text, layout of the full results, and differences between laboratory practices. Typically, these pitfalls can be grouped into one of the following categories:● Data irregularities that include unexpected abbreviations and numerous misspellings; this may result in misclassification or missed cases.● Data changes resulting from shifts in testing practices due to new or discontinued laboratory tests, or differing data entry methods.● Classification challenges for diseases that require sequential testing or clinical compatibility information, which limits the ability to positively identify cases. However, records can be identified as ‘suspect cases’ (i.e., syphilis, Lyme disease, varicella, yellow fever and others).● Technical issues, at the medical facility, server, or EDC level, often causes lapses in data, which results in a delay in case reporting.Despite these pitfalls, their impact can be mitigated by routinely reviewing algorithms, employing data analytic techniques that account for likely misspellings and abbreviations, and incorporating data quality checks that flag unexpected or unclassifiable results. Outside of automated processes, human interaction is important; EDC analysts must remain astute and vigilant to investigate unusual or unexpected occurrences, shifts in the volume of cases or data.ResultsDue to the pitfalls outlined, the EDC has developed powerful and robust methods to circumvent the issues of using administrative health data for near real-time clinical ancillary services based disease surveillance. The methods developed to address the pitfalls of working with administrative health data have been used in the daily active surveillance of over fifty reportable infectious diseases, weekly surveillance of influenza, and monthly surveillance of malaria and tuberculosis. In addition to using these methods for routine surveillance, the EDC adapts this methodology for new reports for specific concerns. Further, the EDC continues to develop and adapt these methodologies to quickly address emerging infectious threats and the pitfalls associated with the data. Pharmacy transactions and administrative data from outpatient encounters and inpatient discharges supplement and enhance laboratory-based surveillance, particularly when only a diagnosis or presumptive treatment occurs (such as with influenza). While this method provides timely information, built in quality assurance checks and routine reviews of algorithms must occur to address changes in testing practices, the use of new tests, variation in laboratory technician entry of results, and to ensure data integrity.ConclusionsThe EDCs comprehensive surveillance provides the DON and DOD leadership and preventive medicine community with the ability to monitor and respond to ongoing and emerging infectious disease threats. While the primary purpose of administrative health data is not for health surveillance, the EDC has recognized the rich source of health information which may be extracted from this data. Processes have been developed to mitigate the pitfalls that may occur when administrative data is adapted for health surveillance. This data provides a real-time snapshot of the health of military beneficiaries and provides awareness of possible outbreaks, health trends, and geographic hotspots. Beyond routine surveillance this data has the potential to be used to rapidly create new methodologies to detect emerging infections which can be combined with other data sources, such as pharmacy transactions and medical encounters, to provide a more robust picture of cases by accounting for variance in clinical practice. This data often guides military health policy and procedures and is essential for a medically ready force. 


Author(s):  
Taylor McLinden ◽  
Rolando Barrios ◽  
Robert Hogg

BackgroundDespite not being collected for research purposes, linked administrative health data are increasingly being used to conduct observational epidemiologic analyses. In the field of HIV research in British Columbia (BC), Canada, the Comparative Outcomes And Service Utilization Trends (COAST) Study is based on a linkage between HIV-related clinical data and several provincial administrative health datasets. Specifically, the BC Centre for Excellence in HIV/AIDS Drug Treatment Program, which manages antiretroviral therapy (ART) dispensation for all known people living with HIV (PLWH) in BC, is linked with several Population Data BC data holdings. Population Data BC is a repository that houses longitudinal administrative data for all BC residents. RationaleWhile the use of administrative data for research poses several challenges, bias due to confounding remains to be a key issue in this context. While randomized controlled trials of ART are common, an objective of COAST is to further examine the "real-world" impact of ART on health and clinical outcomes in a population-based sample of 13,907 PLWH in BC. Therefore, while longitudinal administrative data provide a unique opportunity to estimate the effect of ART on outcomes that are infrequently assessed in trials (e.g., chronic conditions), such data often lacks information on sociodemographic, socioeconomic, and behavioural confounders. ApproachIt has been shown that adjustment for large numbers of covariates, in the form of administrative codes (e.g., diagnostic ICD codes, procedure codes, drug identification numbers), allows for better control of confounding bias. Therefore, relying on an established methodology in pharmacoepidemiology, we will use the high-dimensional propensity score algorithm to select and prioritize covariates (codes) that collectively act as proxies for unmeasured confounders. The use of this causal inference methodology in COAST will enhance our ability to generate stronger evidence to inform strategies that may improve the health and wellbeing of PLWH in this setting.


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