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Clinical encounter heterogeneity and methods for resolving in networked EHR data: A study from N3C and RECOVER programs

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OBJECTIVE Clinical encounter data are heterogeneous and vary greatly from institution to institution. These problems of variance affect interpretability and usability of clinical encounter data for analysis. These problems are magnified when multi-site electronic health record data are networked together. This paper presents a novel, generalizable method for resolving encounter heterogeneity for analysis by combining related atomic encounters into composite ‘macrovisits.’ MATERIALS AND METHODS Encounters were composed of data from 75 partner sites harmonized to a common data model as part of the NIH Researching COVID to Enhance Recovery Initiative, a project of the National Covid Cohort Collaborative. Summary statistics were computed for overall and site-level data to assess issues and identify modifications. Two algorithms were developed to refine atomic encounters into cleaner, analyzable longitudinal clinical visits. RESULTS Atomic inpatient encounters data were found to be widely disparate between sites in terms of length-of-stay and numbers of OMOP CDM measurements per encounter. After aggregating encounters to macrovisits, variance of length-of-stay (LOS) and measurement frequency decreased. A subsequent algorithm to identify hospitalized macrovisits further reduced data variability. DISCUSSION Encounters data are a complex and heterogeneous component of EHR data and these issues are not addressed by existing methods. These types of complex and poorly studied issues contribute to the difficulty of deriving value from EHR data, and these types of foundational, large-scale explorations and developments are necessary to realize the full potential of modern real world data. CONCLUSION This paper presents method developments to work with and resolve EHR encounters data in a generalizable way as a foundation for future analyses and research.
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Clinical encounter heterogeneity and methods for resolving in networked EHR
data: A study from N3C and RECOVER programs
Corresponding Author
Peter Leese
peleese@email.unc.edu
NC TraCS Institute
UNC Chapel Hill
160 N Medical Drive
Chapel Hill, NC 27599
Co-authors
Adit Anand, Department of Bioinformatics, Stony Brook University, Stony Brook, NY, USA
Andrew Girvin, Palantir Technologies, Denver, CO, USA
Tellen Bennett, Department of Pediatrics, University of Colorado Anschutz Medical Campus,
Denver, CO, USA
Janos Hajagos, Department of Bioinformatics, Stony Brook University, Stony Brook, NY, USA
Amin Manna, Palantir Technologies, Denver, CO, USA
Saaya Patel, Department of Bioinformatics, Stony Brook University, Stony Brook, NY, USA
Jason Yoo, Department of Bioinformatics, Stony Brook University, Stony Brook, NY, USA
Emily Pfaff, Department of Medicine, UNC Chapel Hill, Chapel Hill, NC, USA
Richard Moffitt, Department of Bioinformatics, Stony Brook University, Stony Brook, NY, USA
On behalf of the N3C and RECOVER consortia
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NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
ABSTRACT
OBJECTIVE:
Clinical encounter data are heterogeneous and vary greatly from institution to institution. These
problems of variance affect interpretability and usability of clinical encounter data for analysis.
These problems are magnified when multi-site electronic health record data are networked
together. This paper presents a novel, generalizable method for resolving encounter
heterogeneity for analysis by combining related atomic encounters into composite ‘macrovisits.’
MATERIALS AND METHODS:
Encounters were composed of data from 75 partner sites harmonized to a common data model
as part of the NIH Researching COVID to Enhance Recovery Initiative, a project of the National
Covid Cohort Collaborative. Summary statistics were computed for overall and site-level data to
assess issues and identify modifications. Two algorithms were developed to refine atomic
encounters into cleaner, analyzable longitudinal clinical visits.
RESULTS:
Atomic inpatient encounters data were found to be widely disparate between sites in terms of
length-of-stay and numbers of OMOP CDM measurements per encounter. After aggregating
encounters to macrovisits, variance of length-of-stay (LOS) and measurement frequency
decreased. A subsequent algorithm to identify hospitalized macrovisits further reduced data
variability.
DISCUSSION:
Encounters data are a complex and heterogeneous component of EHR data and these issues
are not addressed by existing methods. These types of complex and poorly studied issues
contribute to the difficulty of deriving value from EHR data, and these types of foundational,
large-scale explorations and developments are necessary to realize the full potential of modern
real world data.
CONCLUSION:
This paper presents method developments to work with and resolve EHR encounters data in a
generalizable way as a foundation for future analyses and research.
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
BACKGROUND AND SIGNIFICANCE
While the terms “encounter” and “visit” are used interchangeably to describe many different
types of experiences in healthcare, these terms represent a much more specific concept within
electronic health records (EHRs). In EHR data, the encounter is an atomic, transactional unit of
health service delivery. Encounters can represent single, discrete health care services, such as
an outpatient office visit; multiple unrelated care services, such as multiple outpatient events
over a single or multiple days; or multiple related care events over short or long time periods,
such as the variety of facility and professional services delivered during hospitalization. This
tendency of encounters to function as the building blocks of larger and more complex care
events contributes to their complexity, particularly when assessing patient care longitudinally.
Unfortunately, methods to associate encounters into complete, clinically-recognizable care
experiences are neither proscribed, straightforward, nor harmonized between different
healthcare organizations, different EHR platforms, or even the same EHR platform implemented
at different sites [[1–4]]. Unless resolved (generally on a project-by-project basis), this
heterogeneity and ambiguity can undermine the encounter’s value in analysis.
While working with encounters in the EHR is challenging within a single institution, as with
almost all healthcare data, the lack of recognized, shared standards for the encounter concept
causes even greater harmonization and analytical issues in multi-institution, EHR-based
research. Even when participating institutions use the same common data model (CDM, such as
OMOP, PCORnet, or i2b2/ACT), each of which have mechanisms for incorporating
encounters,[[5–7]] none of the CDMs enforce common rules or definitions for what events
constitute an encounter and how related encounters should be linked. Thus, when an institution
populates a CDM with their EHR data, that institution is typically, simply translating their local
definition(s) for encounters into the CDM, where these data become “harmonized” to the CDM
but remain unstandardized to other encounters. As an example, one site may break inpatient
encounters into a series of separate, discrete short encounters, and another may use one
encounter record for the entire stay.
While many types of encounters are complex, hospitalizations (including inpatient, observation,
extended recovery, and other longitudinal facility-based encounters) are most affected by
encounter ambiguity. Hospitalizations typically span a longer temporal period and tend to
include a greater number of events and associated resources than outpatient encounters. At a
minimum, hospitalizations require the combination of both facility and professional transactions
to capture the full care experience. It is therefore common for hospitalizations to include many
discrete encounter records to capture a wide variety of activities occurring during the
hospitalization, such as imaging, pharmacy, surgery, and other services. A distinct challenge
when working with encounter data for hospitalizations is cleanly identifying each discrete
hospitalization from admission to discharge with all related, co-occurring services. EHR
applications tend to solve this problem by having tables and methods separate from encounters
to account for entire hospitalizations, such as ‘accounts’ or ‘episodes’. However, these
EHR-native methods are not currently represented outside of EHR platforms, particularly in
CDMs, which frequently serve as data exchange standards for research. This means the most
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common research data situation is that data users must attempt to identify and re-aggregate the
components of hospitalizations on their own.
The challenge of working with heterogeneous EHR encounter data can be illustrated by the
National COVID Cohort Collaborative (N3C), which networks EHR data from 75 sites and four
CDMs (OMOP, PCORnet, i2b2/ACT, TriNetX) into a single repository to support
community-driven, reproducible, and transparent COVID-19 analytics[8]. Encounter-level data,
particularly around hospitalizations, are highly desirable for COVID-19 and post-acute sequelae
of SARS-CoV-2 (PASC) research; however, early in the process of assessing N3C data quality,
several obstacles became apparent in the combined, harmonized visit data from participating
sites. One issue is the combination of heterogeneous local encounter definitions (e.g., some
sites send hospitalizations as single visits with longitudinal length-of-stay [LOS] and others send
hospitalizations as a series of discrete, consecutive one-day-long visits). Additionally, some sites
are likely mis-mapping a subset of their encounters to CDM visit types at the local level, such as
incorrectly mapping facility-based outpatient encounters to an inpatient visit type. These issues
result in encounter data that are difficult to analyze as a cohesive whole, and greatly impact the
ability of researchers to quantify and assess events occurring during hospitalizations. For this
reason, N3C recognized the need to create an algorithmic method to collapse concurrent
encounters for the same patient into a single analytical unit, approximating a hospitalization
inclusive of all services.
OBJECTIVE
Local business rules defining inpatient encounters are entrenched in their home organizations,
and are often put in place for pragmatic or business optimization purposes. For this reason, it is
unlikely that encounters (inpatient or otherwise) can be fully standardized from the individual
organizations’ EHRs, short of the creation of national health data standards. The objectives of
this work are then 1) to identify and describe the heterogeneity of harmonized CDM encounter
data in the context of hospitalizations, 2) to enumerate example algorithms for re-combining
transactional EHR encounters post hoc into logical, longitudinal care experiences with
acceptable metadata characteristics, and 3) to examine the results of applying these algorithms
in N3C. This process of combining atomic encounters back into longitudinal clinical experiences
representative of the patient clinical experience, which we termed macrovisit aggregation, can
be applied to an encounter dataset composed of mixed local definitions, and result in a
consistently defined set of longitudinal, multi-encounter experiences, macrovisits, for use in
further analyses.
MATERIALS AND METHODS
Data & Technology
This study is part of the NIH Researching COVID to Enhance Recover (RECOVER) Initiative,
which seeks to understand, treat, and prevent PASC. For more information on RECOVER, visit
https://recovercovid.org.
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The design of the N3C OMOP data repository, the N3C data transformation pipeline, and a
comprehensive characterization of the data available prior to December 2020 have been
previously described[[9,10]]. In the current study, we used N3C data ingested as of 8/26/2022,
which included 75 contributing sites, 15,231,849 distinct patients, and 894,629,506 encounter
records. All technical work was performed in the N3C secure data enclave utilizing the Foundry
technology platform created and maintained by Palantir Technologies Incorporated. All data
engineering and analysis was performed using a combination of Spark SQL, R version 3.5, and
Python version 3.6.
The Macrovisit Aggregation Algorithm
The macrovisit aggregation algorithm aims to combine individual OMOP visit records
(“microvisits”) that appear to be part of the same care experience, and create a single macrovisit
to represent the entirety of the care experience. Events occurring during any microvisit can then
be analyzed in the context of the macrovisit rather than as individual, unrelated encounters.
In short, macrovisit aggregation merges overlapping microvisits with specific features to
determine the total macrovisit’s duration; subsequently, any microvisits occurring within the
timespan of the macrovisit duration are appended. Microvisits from individual sites are sourced
from N3C’s visit_occurrence table. Microvisits qualified to initiate macrovisit aggregation meet
the following criteria:
have non-null start and end dates
have a non-negative LOS, the difference between the visit’s end date and start date
have a recorded visit_type_concept of one of the following OMOP concepts: 262
“Emergency Room and Inpatient Visit,” 8717 “Inpatient Hospital,” 9201 “Inpatient Visit,”
32037 “Intensive Care,” 581379 “Inpatient Critical Care Facility”
In addition to these inpatient-centric macrovisits, certain longitudinal, outpatient facility stays can
generate macrovisits; namely, microvisits with LOS >= 2 days and type 9203 “Emergency Room
Visit,” 8756 “Outpatient Hospital,” or 581385 “Observation Room.”
Microvisits that fulfill these criteria are kernels for eventual macrovisits. Qualifying microvisits
with overlapping dates are merged into a continuous scaffold until a gap of 1 or more calendar days
occurs between the end date of the last component microvisit and the start of the next. Once there
is a gap of at least 1 day, a discrete macrovisit is created and assigned the earliest visit start date
(macrovisit start date) and latest visit end date (macrovisit end date) of its component microvisits.
Finally, any microvisits of any type that overlaps with this scaffold are joined into the macrovisit.
Once there is a gap of at least 1 day, a discrete macrovisit is created and assigned the earliest
visit start date (macrovisit start date) and latest visit end date (macrovisit end date) of its
component microvisits. Figure 1 illustrates macrovisit aggregation with example microvisit data.
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Figure 1: Macrovisit aggregation. Visual representation of the algorithm for aggregating
heterogeneous, overlapping microvisits into discrete macrovisits.
The High-Confidence Hospitalization Algorithm
Initial analysis of macrovisit aggregation output showed an unusually high frequency of 0-day
macrovisits, suggesting a substantially larger number of extremely short hospitalizations, and
indicating a hospitalization length-of-stay deviating from the expected distribution[[11–13]]. The
typical expected distribution of hospital length-of-stay for an acute care hospital is approximately
Poisson or negative binomial distributed with a central tendency around 2 to 4 days. This
indicated that a macrovisit was not equivalent to a hospitalization in all cases. There are several
possible explanations for this finding, including mislabelling of outpatient visits by sites as
inpatient type, mislabeling a brief inpatient service (such as critical care) as an entire
hospitalization without sending additional data, or inaccurately recording the visit start and/or
end date. It became clear that additional filtering was required to further classify macrovisits into
the categories of “high-confidence hospitalization” and “non-hospitalization macrovisits.” Due to
the heterogeneity of visit data submitted between the many N3C sites, an ensemble of
approaches was constructed to attempt to perform this classification, independent of either LOS
or site-submitted visit_concept_types. Criteria included:
Presence of diagnosis-related group (DRG) codes for any component microvisit
OR
Presence of Centers for Medicare & Medicaid Services (CMS)-indicated inpatient-only
Current Procedural Terminology (CPT) codes [[14]] on any component microvisit
OR
Presence of either an inpatient or critical care (ICU) evaluation & management
Healthcare Common Procedure Coding System (HCPCS) code on any component
microvisit
OR
Presence of either an inpatient or ICU SNOMED CT concept on any microvisit procedure
OR
A minimum of 50 total resources recorded for at least 1 component microvisit (where
total resources consists of the total count of all diagnoses, procedures, medications,
measurements, and observations at the microvisit level)
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The resources attributed to each macrovisit (hereafter ‘resource density’) LOS is illustrated in
Figure 2. Examination of all these indicators simultaneously facilitated identifying macrovisits
with either inpatient hospital care delivery or with a resource pattern consistent with a likely
longitudinal hospital encounter.
Figure 2: Resource density by length of stay. Visual representation of the variation in
maximum resource density across macrovisits as LOS changes. Each color corresponds to a
maximum resource density bin. The macrovisits with greater than 50 maximum resources
roughly follow the expected inpatient LOS distribution, and a majority of 0-day LOS
macrovisits have no more than 25 maximum resources.
Assessing Site-to-Site Encounter Heterogeneity
To assess the performance of the macrovisit aggregation algorithm, the characteristics of
microvisits labeled as inpatient (visit types 262 “Emergency Room and Inpatient Visit,” 8717
“Inpatient Hospital,” 9201 “Inpatient Visit,” 32037 “Intensive Care,” or 581379 “Inpatient Critical
Care Facility”) from the visit_occurrence table were compared to the generated macrovisits
across all N3C sites. Measurement (defined as data from the OMOP measurements table,
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consisting of labs, vitals, and other structured quantitative clinical assessments) frequency is
included to illustrate the data density compiled into the macrovisits from the component
microvisits and to identify data quality issues, such as long macrovisits with a small number of
associated measurements. The goal was to ensure that the algorithm behaved similarly across
sites, and decreased heterogeneity. The workflow for assessing performance is detailed in Table
1.
Table 1. Steps taken to asses site-level encounter heterogeneity
Analysis Step
Rationale
Length of Stay
Filter out inpatient visits with negative LOS data
Negative LOS visits excluded from macrovisits
Compute summary statistics of LOS information
for each site’s inpatient visits, macrovisits,
high-confidence hospitalizations
Assess and compare distributions and measures
of central tendency
Visualize sites’ LOS summary statistics when visit
aggregation causes median LOS change >=2
days
Assess impact of algorithms on summary statistics
Measurements
Filter out measurement data with missing result
values
Exclude data with extraction, mapping, and
submission issues or otherwise missing data
Calculate measurement frequency for inpatient
visits, macrovisits, and high-confidence
hospitalizations
Quantify heterogeneity in a proxy of data quality
before and after macrovisit creation
Compute summary statistics of measurement
frequency for each site’s inpatient visits,
macrovisits, high-confidence hospitalizations
Assess and compare distributions and measures
of central tendency
Visualize sites’ measurement summary statistics
when an algorithm causes median measurement
frequency to change by >=30
Assess impact of algorithms on summary statistics
Macrovisit Composition
Calculate microvisit frequency within each
macrovisit and high-confidence hospitalization
Quantify heterogeneity in microvisits being
aggregated to larger care experiences
Compute summary statistics of microvisit
frequency for each site’s inpatient visits,
macrovisits, high-confidence hospitalizations
Assess and compare distributions and measures
of central tendency
Visualize sites’ microvisit frequency summary
statistics when visit aggregation causes median
microvisit frequency to change by >=1
Assess impact of algorithms on summary statistics
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Overall
Filter out data from sites with identified data
quality issues (frequent data missingness or
incorrect units in measurement data, unreliable
visit information, systematic data errors)
Exclude low-quality data to minimize
measurement error and bias
RESULTS
Macrovisit Composition Heterogeneity
To illustrate variance in site-level encounter definitions, Figure 3 shows a sampling of macrovisit
composition across N3C sites. Each facet represents a single, randomly selected macrovisit
while the colored bars indicate the variety and duration of component microvisits making up the
macrovisit. It is worth noting that the microvisits labeled as ‘office visit’ or ‘outpatient visit’ might
logically represent the professional component of facility care delivery instead of true, discrete
ambulatory visits; however, that cannot be determined conclusively. Similarly, it is not possible to
determine what true visit types might be represented by the abundance of microvisits labeled as
“no matching concept” in the OMOP vocabulary. Despite these unknowns, it is clear that, as
expected, macrovisits are diverse and represent a wide variety of encounter types and durations
over longitudinal care.
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Figure 3:Microvisit heterogeneity within macrovisits. Visual representation of the variety
and duration of microvisits within a single, randomly-selected macrovisit for each site. For
example, site 2 has a macrovisit consisting of one longitudinal inpatient visit with a variety of
0-day visits spread throughout the stay. Site 8 has a macrovisit consisting of 2 connected
inpatient stays, again with a variety of 0-day visits over the entire macrovisit.
Assessing Algorithm Impact
In addition to the composition of macrovisits, the impact of algorithms was also assessed by
examining LOS, measurement frequency, and microvisit frequency within macrovisits. As
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illustrated previously when assessing composition in Figure 3, microvisit frequency is an
important exploratory metric to understand the makeup of macrovisits and the underlying visit
data heterogeneity. LOS is also a vital metric to identify the algorithm’s success in
aggregating microvisits into plausible longitudinal stays that are usable for other analyses.
The results of these assessments are shown in Table 2.
Table 2. Summary statistics of measured features for inpatient microvisits and both
algorithms.
Feature
min
Q1
median
mean (sd)
Q3
Inpatient Visit
n = 16,421,633
Length of stay
0
0
1
5.4 (19.3)
5
Macrovisit
n = 10,577,329
0
0
2
4.5 (12.4)
5
High-Confidence
Hospitalization
n = 7,434,312
0
2
3
5.9 (13.8)
6
Inpatient Visit
Measurements per
longitudinal stay
1
14
58
192.4 (750.6)
166
Macrovisit
1
27
82
244.3 (1288.7)
205
High-Confidence
Hospitalization
1
44
103
279.1 (1,378.5)
237
Macrovisit
Microvisits per
macrovisit
1
1
2
5.6 (14.9)
6
High-Confidence
Hospitalization
1
1
3
7.0 (17.5)
7
Length-of-Stay Impact
From Table 2 and supplemental Figure 1 it is apparent that both inpatient microvisits and
macrovisits have a large proportion of zero-day care experiences, which would be unusual in
true hospitalizations. In the N3C inpatient visits data, over 40% of all visits are reported as
zero-day inpatient visits, which fails face validity. The characteristics of LOS are improved
somewhat by the macrovisit algorithm as the median moves from 1 to 2 days; however,
zero-day hospitalizations are still over-represented. Applying the high-confidence hospitalization
algorithm moves the LOS distribution further to the right, bringing the median to 3 days. These
effects are illustrated in Figure 4 for a subset of sites, showing the increase in LOS from visits to
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macrovisits to high-confidence hospitalizations. Additional LOS data is shown in supplemental
Figures 1 and 2.
Figure 4: Length-of-stay. LOS distributions for inpatient visits, macrovisits, and
high-confidence hospitalizations for the subset of sites with most variance between raw data
and algorithm results (median=circle, mean=triangle, IQR=line).
Microvisit Frequency Impact
The fundamental composition of macrovisits was explored by examining the frequency of
microvisits within macrovisits. The mean microvisits per macrovisit were 5.6 and 7.0 for base
macrovisits and high-confidence hospitalizations, respectively. Similarly, the median shifted from
2 to 3 from macrovisits to hospitalizations, collectively indicating a small increase in microvisit
density from the macrovisit algorithm to the high-confidence hospitalization algorithm. Both sets
of data retain a sizable amount of heterogeneity in microvisit composition with a standard
deviation of 14.9 and 17.5, respectively for macrovisits and high-confidence hospitalizations.
These data are illustrated for a subset of sites in Figure 5, showing the interquartile range,
mean, and median of microvisit frequency for both macrovisits and high-confidence
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hospitalizations. The overall tendency of the algorithms to create increasingly microvisit-dense
macrovisits is apparent from this figure.
Figure 5: Microvisit density. Distribution of the number of component microvisits within
macrovisits and high-confidence hospitalizations for the subset of sites with most variance
between macrovisit algorithm and high-confidence hospitalization algorithm results
(median=circle, mean=triangle, IQR=line).
Measurement Frequency
OMOP measurements data was explored for macrovisits as a proxy of overall clinical data
contained within each macrovisit. As the macrovisit and high-confidence hospitalization
concepts should represent longitudinal care experiences rich with clinical data compared to
single visits, measurement frequency per macrovisit is a valuable quality indicator of the
function of the algorithms. This general trend is apparent as the mean measurements per
inpatient visits is 192.3 compared to 244.3 and 279.1 for broad macrovisits and
high-confidence hospitalizations, respectively. Similarly, the medians for these groups
increase from 58 to 82 to 103, illustrating the rightward shift of the distributions and overall
increasing density of measurements data. Measurement frequency data are shown in Figure
6, showing the site-level IQR, mean, and median for sites with the most variation from raw
visits to macrovisits and hospitalizations.
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Figure 6: Measurement Density. Distribution of the number of measurements within
inpatient visits, macrovisits, and high-confidence hospitalizations for the subset of sites with
most variance between raw data and algorithm results (median=circle, mean=triangle,
IQR=line).
DISCUSSION
The present study provides an illustration of the service delivery heterogeneity present in EHR
data across 75 N3C partner sites in the US, and demonstrates that this heterogeneity is not
resolved through the application of CDMs and data harmonization efforts alone. We have
demonstrated successful use of an algorithm in addition to CDM harmonization to aggregate
and classify EHR visits generated from varied, site-specific operational rules and data extraction
approaches into comprehensive macrovisits more reflective of actual clinical experience.
Additionally we have demonstrated that, depending on the desired outcomes, multiple
successive algorithms may be necessary to parse aggregated data into data suitable for
analysis.
Service delivery heterogeneity and the lack of continuity between actual clinical experience and
subsequently generated data is a universal issue in EHR encounter data. Moreso, significant
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variation in clinical service delivery has and continues to be universally documented [[15–17]]
both within and between hospitals and the corollary to this led to a similar variation in EHR
implementation, utilization, and ultimately clinical data documented and produced[[18] [19]]. This
variation is a major obstacle to performing accurate, reliable analysis of EHR data across
multiple sites. All major CDMs receive atomic care delivery data, but must rely on the
implementing site to apply rules to make this data accurate and representative of actual clinical
care. Beginning the systematic process of identifying and quantifying these types of EHR
heterogeneity is foundational to understanding error and misclassification in real world-data and
to deriving value from these data.
While we refer to the macrovisit as a new concept, it is necessary to differentiate it from
pre-existing clinical service aggregation methods such as bundles and care episodes. Care
bundles typically refer to the linking of care services occurring over various time periods for the
same underlying medical situation for the purpose of paying a limited number of bundled
payments as opposed to transactional fee-for-service or DRG-based payments. The most
common example of bundles would be the CMS bundled payment initiatives for conditions such
as major joint replacement, pacemaker implantation, stroke, etc. Care episode is a more flexible
term used to describe the linking of related care events over time for any purpose - payment or
clinical. Care episodes may be short and discrete, such as an episode for the care following
minor trauma, or long such as the long-term range of services for chronic conditions with
exacerbations, such as sickle cell anemia. In contrast to bundles and episodes, macrovisits are
intended for the much more focused purpose of linking encounters together to fully represent
the services experienced during a discrete hospitalization, very similarly to the intrinsic linking of
encounters inside many EHR systems for actions such as facility billing. In contrast to bundles
and episodes, macrovisits do not seek to add additional, potentially clinically-related services
that occurred outside the temporal window of the hospitalization[[20,21]]. Additionally, the
strategy employed in the currently described macrovisit aggregation algorithm is very similar to
existing strategies that have both been published, disseminated, and otherwise anecdotally
used in other datasets[[20,22]].
While the algorithms discussed are rule-based and lack the apparent dynamism of a
machine-learning based approach, they are foundational steps in formally identifying and
quantifying EHR data heterogeneity within and between sites and creating generalizable
solutions to resolve these issues. There have been some discussions around the necessity of
this type of work due to the perception that these issues will be resolved either through the
inherent ingestion and harmonization pipelines of CDMs or through new data interfacing
paradigms, such as Health Level Seven’s Fast Healthcare Interoperability Resources (FHIR)
[[23]]. FHIR accounts for the possibility of aggregating encounters with the partOf element in the
Encounter resource. However, because partOf is not a required field in FHIR, it remains to be
seen what proportion of FHIR-ready sites will choose to use this element and how much
variation will be seen in its use. Similarly, the experience of working across N3C, the largest
harmonized CDM repository in the US, has demonstrated that the CDM harmonization
mechanisms currently in place are not sufficient to harmonize encounter data.
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
Ultimately, assessing encounter heterogeneity and methods to aggregate encounters into larger
hospitalizations is important because utilizing raw visit data misleads many analyses. Notably,
using raw inpatient visits to identify hospitalizations, and therefore more severe encounters, in
N3C data led to an undercounting of severe cases of COVID-19. While it may be tempting to
attempt to solve this issue at the source (the EHR itself), it may be more advantageous to
combine visits into macrovisits post hoc instead, which allows for more definitional flexibility for
projects and research questions with different needs. Using a post hoc method, the “raw”
transactional visits are always available in the source data instead of destroyed in a
transformation that may be upstream and opaque to the end user. This also leaves room for
multiple shared macrovisit-like algorithms to serve different use cases, which, for example, may
wish to preserve differences between inpatient stays and extended holds in the emergency
department. It would also be valuable and worthwhile to consider CDM schema extensions to
facilitate the loading of hospitalization and hospital facility data and groupings that already occur
in EHR platforms, such as the “account” concept in the Epic platform. While these concepts are
unlikely complete solutions to the visit issues described and would likely have their own
heterogeneity both within and between sites, they offer a significantly more evolved and refined
mechanism for dealing with hospitalizations from the EHR.
To put encounter and other EHR data issues into perspective, we must step back and consider
the policy landscape that heralded in our current national landscape of electronic health records.
A major goal of the HITECH Act, as a component of American Recovery and Reinvestment Act
(ARRA), was to incentivize the adoption of EHRs at a national scale in the US - an effort which,
by almost any measure, has been successful [cite]. While this evolution from paper to digital
health records has arguably had some intended effect of facilitating more interoperability, data
sharing, and care delivery innovations, it has also had the unintended consequence of making
transparent the enormous variations in clinical care, care documentation, and EHR
implementation in the US healthcare system [[24]]. From an informatics perspective these
issues are manifest in the tremendous heterogeneity present in EHR data, both intra- and
inter-site. In the short-term following HITECH, programs such as Meaningful Use [[25]]
attempted to create a standard functionality floor for EHRs by requiring such data as vitals to be
able to be input and retrieved, or computerized physician order entry to be performed, but the
focus of these programs was to incentivize the adoption of functional, reliable EHR platforms,
not to create EHR data standards. Similarly, the private market of EHR vendors has facilitated
this by allowing and supporting local customization EHR implementation and maintenance.
These issues of variation and heterogeneity have always been present and problematic locally,
but have become more obtrusive as EHRs have become more prominent and multi-site clinical
research networks have developed. In the N3C data enclave, the largest centralized repository
of multi-site, harmonized EHR data produced to-date in the US, the full scale of these national
issues is manifest. At a high level, this begs the question of how to improve EHR data and CDM
ingestion and standardization to make EHR data more usable in future work. There are
incremental modifications that could be made within individual sites, EHR platforms, or CDMs
that begin to ameliorate these varied issues. One such suggestion would be for CDMs to require
both atomic encounters from EHR data and also the EHR-native hospitalizations with keys
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
between the two. The more systemic solution, though, would be for healthcare, like many
sectors before, to adopt widespread data standards either through regulation, as in finance, or
through industry-sponsored, multilateral working groups, as many standards in technology use.
Until that point, an excess of time will continue to be spent on figuring out how to get value from
healthcare data instead of getting value from healthcare data.
Limitations
As has been well documented, missingness is a common issue with all EHR data, N3C
included. When data is missing or null it is not possible to make assumptions about the data or
the intent of the data provider[[26–29]]. Similarly, some data, while present, appears to be
illogical or mis-mapped, which is equally difficult to interpret and use. Due to the nature of the
N3C data ingestion and de-identification policies, it is not possible to validate our algorithms’
assumptions using chart review. Thus, a logical next step for this work is to perform validation by
running the macrovisit algorithms on local site data--preferably a selection of sites with different
local definitions for encounters.
CONCLUSION
The macrovisit aggregation methodology illustrates the opportunities and challenges presented
while using multi-site encounter data, and defines a repeatable algorithm to sensibly merge
visits and identify true hospitalizations. The generation of derivative, harmonized inpatient
encounters enables comparable and consistent analytics from site-to-site. Since this sweep-line
algorithm is developed based on OMOP CDM, this study broadens its scope and could be
leveraged to other contexts of pooled EHR data.
ACKNOWLEDGEMENT
Authorship was determined using ICMJE recommendations. The content is solely the
responsibility of the authors and does not necessarily represent the official views of the National
Institutes of Health, N3C, or RECOVER.
This study is part of the NIH Researching COVID to Enhance Recovery (RECOVER)
Initiative, which seeks to understand, treat, and prevent the post-acute sequelae of
SARS-CoV-2 infection (PASC). For more information on RECOVER, visit
https://recovercovid.org/. This research was funded by the National Institutes of Health (NIH)
Agreement OTA OT2HL161847 as part of the Researching COVID to Enhance Recovery
(RECOVER) research program.
We would like to thank the National Community Engagement Group (NCEG), all patient,
caregiver and community Representatives, and all the participants enrolled in the RECOVER
Initiative.
The analyses described in this publication were conducted with data or tools accessed through
the NCATS N3C Data Enclave covid.cd2h.org/enclave and supported by CD2H - The National
COVID Cohort Collaborative (N3C) IDeA CTR Collaboration 3U24TR002306-04S2 NCATS U24
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
TR002306. This research was possible because of the patients whose information is included
within the data from participating organizations (covid.cd2h.org/dtas) and the organizations and
scientists (covid.cd2h.org/duas) who have contributed to the on-going development of this
community resource (cite this https://doi.org/10.1093/jamia/ocaa196).
The N3C data transfer to NCATS is performed under a Johns Hopkins University Reliance
Protocol # IRB00249128 or individual site agreements with NIH. The Data Use Request ID is
DUR-94BBC49. The N3C Data Enclave is managed under the authority of the NIH; information
can be found at https://ncats.nih.gov/n3c/resources.
We gratefully acknowledge the following core contributors to N3C:
Adam B. Wilcox, Adam M. Lee, Alexis Graves, Alfred (Jerrod) Anzalone, Amin Manna, Amit
Saha, Amy Olex, Andrea Zhou, Andrew E. Williams, Andrew Southerland, Andrew T. Girvin,
Anita Walden, Anjali A. Sharathkumar, Benjamin Amor, Benjamin Bates, Brian Hendricks,
Brijesh Patel, Caleb Alexander, Carolyn Bramante, Cavin Ward-Caviness, Charisse
Madlock-Brown, Christine Suver, Christopher Chute, Christopher Dillon, Chunlei Wu, Clare
Schmitt, Cliff Takemoto, Dan Housman, Davera Gabriel, David A. Eichmann, Diego Mazzotti,
Don Brown, Eilis Boudreau, Elaine Hill, Elizabeth Zampino, Emily Carlson Marti, Emily R. Pfaff,
Evan French, Farrukh M Koraishy, Federico Mariona, Fred Prior, George Sokos, Greg Martin,
Harold Lehmann, Heidi Spratt, Hemalkumar Mehta, Hongfang Liu, Hythem Sidky, J.W. Awori
Hayanga, Jami Pincavitch, Jaylyn Clark, Jeremy Richard Harper, Jessica Islam, Jin Ge, Joel
Gagnier, Joel H. Saltz, Joel Saltz, Johanna Loomba, John Buse, Jomol Mathew, Joni L. Rutter,
Julie A. McMurry, Justin Guinney, Justin Starren, Karen Crowley, Katie Rebecca Bradwell, Kellie
M. Walters, Ken Wilkins, Kenneth R. Gersing, Kenrick Dwain Cato, Kimberly Murray, Kristin
Kostka, Lavance Northington, Lee Allan Pyles, Leonie Misquitta, Lesley Cottrell, Lili Portilla,
Mariam Deacy, Mark M. Bissell, Marshall Clark, Mary Emmett, Mary Morrison Saltz, Matvey B.
Palchuk, Melissa A. Haendel, Meredith Adams, Meredith Temple-O'Connor, Michael G. Kurilla,
Michele Morris, Nabeel Qureshi, Nasia Safdar, Nicole Garbarini, Noha Sharafeldin, Ofer Sadan,
Patricia A. Francis, Penny Wung Burgoon, Peter Robinson, Philip R.O. Payne, Rafael Fuentes,
Randeep Jawa, Rebecca Erwin-Cohen, Rena Patel, Richard A. Moffitt, Richard L. Zhu, Rishi
Kamaleswaran, Robert Hurley, Robert T. Miller, Saiju Pyarajan, Sam G. Michael, Samuel
Bozzette, Sandeep Mallipattu, Satyanarayana Vedula, Scott Chapman, Shawn T. O'Neil, Soko
Setoguchi, Stephanie S. Hong, Steve Johnson, Tellen D. Bennett, Tiffany Callahan, Umit
Topaloglu, Usman Sheikh, Valery Gordon, Vignesh Subbian, Warren A. Kibbe, Wenndy
Hernandez, Will Beasley, Will Cooper, William Hillegass, Xiaohan Tanner Zhang. Details of
contributions available at covid.cd2h.org/core-contributors
The following institutions whose data is released or pending:
Available: Advocate Health Care Network — UL1TR002389: The Institute for Translational
Medicine (ITM) • Boston University Medical Campus — UL1TR001430: Boston University
Clinical and Translational Science Institute • Brown University — U54GM115677: Advance
Clinical Translational Research (Advance-CTR) • Carilion Clinic — UL1TR003015: iTHRIV
Integrated Translational health Research Institute of Virginia • Charleston Area Medical Center
— U54GM104942: West Virginia Clinical and Translational Science Institute (WVCTSI) •
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
Children’s Hospital Colorado — UL1TR002535: Colorado Clinical and Translational Sciences
Institute • Columbia University Irving Medical Center — UL1TR001873: Irving Institute for
Clinical and Translational Research • Duke University — UL1TR002553: Duke Clinical and
Translational Science Institute • George Washington Children’s Research Institute —
UL1TR001876: Clinical and Translational Science Institute at Children’s National (CTSA-CN) •
George Washington University — UL1TR001876: Clinical and Translational Science Institute at
Children’s National (CTSA-CN) • Indiana University School of Medicine — UL1TR002529:
Indiana Clinical and Translational Science Institute • Johns Hopkins University —
UL1TR003098: Johns Hopkins Institute for Clinical and Translational Research • Loyola
Medicine — Loyola University Medical Center • Loyola University Medical Center —
UL1TR002389: The Institute for Translational Medicine (ITM) • Maine Medical Center —
U54GM115516: Northern New England Clinical & Translational Research (NNE-CTR) Network •
Massachusetts General Brigham — UL1TR002541: Harvard Catalyst • Mayo Clinic Rochester
— UL1TR002377: Mayo Clinic Center for Clinical and Translational Science (CCaTS) • Medical
University of South Carolina — UL1TR001450: South Carolina Clinical & Translational
Research Institute (SCTR) • Montefiore Medical Center — UL1TR002556: Institute for Clinical
and Translational Research at Einstein and Montefiore • Nemours — U54GM104941: Delaware
CTR ACCEL Program • NorthShore University HealthSystem — UL1TR002389: The Institute for
Translational Medicine (ITM) • Northwestern University at Chicago — UL1TR001422:
Northwestern University Clinical and Translational Science Institute (NUCATS) • OCHIN —
INV-018455: Bill and Melinda Gates Foundation grant to Sage Bionetworks • Oregon Health &
Science University — UL1TR002369: Oregon Clinical and Translational Research Institute •
Penn State Health Milton S. Hershey Medical Center — UL1TR002014: Penn State Clinical and
Translational Science Institute • Rush University Medical Center — UL1TR002389: The Institute
for Translational Medicine (ITM) • Rutgers, The State University of New Jersey —
UL1TR003017: New Jersey Alliance for Clinical and Translational Science • Stony Brook
University — U24TR002306 • The Ohio State University — UL1TR002733: Center for Clinical
and Translational Science • The State University of New York at Buffalo — UL1TR001412:
Clinical and Translational Science Institute • The University of Chicago — UL1TR002389: The
Institute for Translational Medicine (ITM) • The University of Iowa — UL1TR002537: Institute for
Clinical and Translational Science • The University of Miami Leonard M. Miller School of
Medicine — UL1TR002736: University of Miami Clinical and Translational Science Institute •
The University of Michigan at Ann Arbor — UL1TR002240: Michigan Institute for Clinical and
Health Research • The University of Texas Health Science Center at Houston — UL1TR003167:
Center for Clinical and Translational Sciences (CCTS) • The University of Texas Medical Branch
at Galveston — UL1TR001439: The Institute for Translational Sciences • The University of Utah
— UL1TR002538: Uhealth Center for Clinical and Translational Science • Tufts Medical Center
— UL1TR002544: Tufts Clinical and Translational Science Institute • Tulane University —
UL1TR003096: Center for Clinical and Translational Science • University Medical Center New
Orleans — U54GM104940: Louisiana Clinical and Translational Science (LA CaTS) Center •
University of Alabama at Birmingham — UL1TR003096: Center for Clinical and Translational
Science • University of Arkansas for Medical Sciences — UL1TR003107: UAMS Translational
Research Institute • University of Cincinnati — UL1TR001425: Center for Clinical and
Translational Science and Training • University of Colorado Denver, Anschutz Medical Campus
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
— UL1TR002535: Colorado Clinical and Translational Sciences Institute • University of Illinois at
Chicago — UL1TR002003: UIC Center for Clinical and Translational Science • University of
Kansas Medical Center — UL1TR002366: Frontiers: University of Kansas Clinical and
Translational Science Institute • University of Kentucky — UL1TR001998: UK Center for Clinical
and Translational Science • University of Massachusetts Medical School Worcester —
UL1TR001453: The UMass Center for Clinical and Translational Science (UMCCTS) •
University of Minnesota — UL1TR002494: Clinical and Translational Science Institute •
University of Mississippi Medical Center — U54GM115428: Mississippi Center for Clinical and
Translational Research (CCTR) • University of Nebraska Medical Center — U54GM115458:
Great Plains IDeA-Clinical & Translational Research • University of North Carolina at Chapel Hill
— UL1TR002489: North Carolina Translational and Clinical Science Institute • University of
Oklahoma Health Sciences Center — U54GM104938: Oklahoma Clinical and Translational
Science Institute (OCTSI) • University of Rochester — UL1TR002001: UR Clinical &
Translational Science Institute • University of Southern California — UL1TR001855: The
Southern California Clinical and Translational Science Institute (SC CTSI) • University of
Vermont — U54GM115516: Northern New England Clinical & Translational Research
(NNE-CTR) Network • University of Virginia — UL1TR003015: iTHRIV Integrated Translational
health Research Institute of Virginia • University of Washington — UL1TR002319: Institute of
Translational Health Sciences • University of Wisconsin-Madison — UL1TR002373: UW
Institute for Clinical and Translational Research • Vanderbilt University Medical Center —
UL1TR002243: Vanderbilt Institute for Clinical and Translational Research • Virginia
Commonwealth University — UL1TR002649: C. Kenneth and Dianne Wright Center for Clinical
and Translational Research • Wake Forest University Health Sciences — UL1TR001420: Wake
Forest Clinical and Translational Science Institute • Washington University in St. Louis —
UL1TR002345: Institute of Clinical and Translational Sciences • Weill Medical College of Cornell
University — UL1TR002384: Weill Cornell Medicine Clinical and Translational Science Center •
West Virginia University — U54GM104942: West Virginia Clinical and Translational Science
Institute (WVCTSI)
Submitted: Icahn School of Medicine at Mount Sinai — UL1TR001433: ConduITS Institute for
Translational Sciences • The University of Texas Health Science Center at Tyler —
UL1TR003167: Center for Clinical and Translational Sciences (CCTS) • University of California,
Davis — UL1TR001860: UCDavis Health Clinical and Translational Science Center • University
of California, Irvine — UL1TR001414: The UC Irvine Institute for Clinical and Translational
Science (ICTS) • University of California, Los Angeles — UL1TR001881: UCLA Clinical
Translational Science Institute • University of California, San Diego — UL1TR001442: Altman
Clinical and Translational Research Institute • University of California, San Francisco —
UL1TR001872: UCSF Clinical and Translational Science Institute
Pending: Arkansas Children’s Hospital — UL1TR003107: UAMS Translational Research
Institute • Baylor College of Medicine — None (Voluntary) • Children’s Hospital of Philadelphia
— UL1TR001878: Institute for Translational Medicine and Therapeutics • Cincinnati Children’s
Hospital Medical Center — UL1TR001425: Center for Clinical and Translational Science and
Training • Emory University — UL1TR002378: Georgia Clinical and Translational Science
Alliance • HonorHealth — None (Voluntary) • Loyola University Chicago — UL1TR002389: The
Institute for Translational Medicine (ITM) • Medical College of Wisconsin — UL1TR001436:
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted October 17, 2022. ; https://doi.org/10.1101/2022.10.14.22281106doi: medRxiv preprint
Clinical and Translational Science Institute of Southeast Wisconsin • MedStar Health Research
Institute — UL1TR001409: The Georgetown-Howard Universities Center for Clinical and
Translational Science (GHUCCTS) • MetroHealth — None (Voluntary) • Montana State
University — U54GM115371: American Indian/Alaska Native CTR • NYU Langone Medical
Center — UL1TR001445: Langone Health’s Clinical and Translational Science Institute •
Ochsner Medical Center — U54GM104940: Louisiana Clinical and Translational Science (LA
CaTS) Center • Regenstrief Institute — UL1TR002529: Indiana Clinical and Translational
Science Institute • Sanford Research — None (Voluntary) • Stanford University —
UL1TR003142: Spectrum: The Stanford Center for Clinical and Translational Research and
Education • The Rockefeller University — UL1TR001866: Center for Clinical and Translational
Science • The Scripps Research Institute — UL1TR002550: Scripps Research Translational
Institute • University of Florida — UL1TR001427: UF Clinical and Translational Science Institute
• University of New Mexico Health Sciences Center — UL1TR001449: University of New Mexico
Clinical and Translational Science Center • University of Texas Health Science Center at San
Antonio — UL1TR002645: Institute for Integration of Medicine and Science • Yale New Haven
Hospital — UL1TR001863: Yale Center for Clinical Investigation
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... The index date (initial observation period) was the first of either laboratory confirmed SARS-CoV-2 or the presence of at least one of several "strong positive" COVID-19 related diagnosis, as defined by the N3C version 3.3 phenotype [12]. Visits were defined according to the macrovisit aggregation algorithm available in the N3C enclave which combines individual OMOP visit records that appear to be part of the same care experience [15]. This is crucial as clinical encounter data is highly heterogeneous at both the CDM and institutional level. ...
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Background Multi-institution electronic health records (EHR) are a rich source of real world data (RWD) for generating real world evidence (RWE) regarding the utilization, benefits and harms of medical interventions. They provide access to clinical data from large pooled patient populations in addition to laboratory measurements unavailable in insurance claims-based data. However, secondary use of these data for research requires specialized knowledge and careful evaluation of data quality and completeness. We discuss data quality assessments undertaken during the conduct of prep-to-research, focusing on the investigation of treatment safety and effectiveness. Methods Using the National COVID Cohort Collaborative (N3C) enclave, we defined a patient population using criteria typical in non-interventional inpatient drug effectiveness studies. We present the challenges encountered when constructing this dataset, beginning with an examination of data quality across data partners. We then discuss the methods and best practices used to operationalize several important study elements: exposure to treatment, baseline health comorbidities, and key outcomes of interest. Results We share our experiences and lessons learned when working with heterogeneous EHR data from over 65 healthcare institutions and 4 common data models. We discuss six key areas of data variability and quality. (1) The specific EHR data elements captured from a site can vary depending on source data model and practice. (2) Data missingness remains a significant issue. (3) Drug exposures can be recorded at different levels and may not contain route of administration or dosage information. (4) Reconstruction of continuous drug exposure intervals may not always be possible. (5) EHR discontinuity is a major concern for capturing history of prior treatment and comorbidities. Lastly, (6) access to EHR data alone limits the potential outcomes which can be used in studies. Conclusions The creation of large scale centralized multi-site EHR databases such as N3C enables a wide range of research aimed at better understanding treatments and health impacts of many conditions including COVID-19. As with all observational research, it is important that research teams engage with appropriate domain experts to understand the data in order to define research questions that are both clinically important and feasible to address using these real world data.
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Objective: Coronavirus disease 2019 (COVID-19) poses societal challenges that require expeditious data and knowledge sharing. Though organizational clinical data are abundant, these are largely inaccessible to outside researchers. Statistical, machine learning, and causal analyses are most successful with large-scale data beyond what is available in any given organization. Here, we introduce the National COVID Cohort Collaborative (N3C), an open science community focused on analyzing patient-level data from many centers. Materials and Methods: The Clinical and Translational Science Award Program and scientific community created N3C to overcome technical, regulatory, policy, and governance barriers to sharing and harmonizing individual-level clinical data. We developed solutions to extract, aggregate, and harmonize data across organizations and data models, and created a secure data enclave to enable efficient, transparent, and reproducible collaborative analytics. Results: Organized in inclusive workstreams, we created legal agreements and governance for organizations and researchers; data extraction scripts to identify and ingest positive, negative, and possible COVID-19 cases; a data quality assurance and harmonization pipeline to create a single harmonized dataset; population of the secure data enclave with data, machine learning, and statistical analytics tools; dissemination mechanisms; and a synthetic data pilot to democratize data access. Conclusions: The N3C has demonstrated that a multisite collaborative learning health network can overcome barriers to rapidly build a scalable infrastructure incorporating multiorganizational clinical data for COVID-19 an-alytics. We expect this effort to save lives by enabling rapid collaboration among clinicians, researchers, and data scientists to identify treatments and specialized care and thereby reduce the immediate and long-term impacts of COVID-19.
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Background In response to COVID-19, the informatics community united to aggregate as much clinical data as possible to characterize this new disease and reduce its impact through collaborative analytics. The National COVID Cohort Collaborative (N3C) is now the largest publicly available HIPAA limited dataset in US history with over 6.4 million patients and is a testament to a partnership of over 100 organizations. Methods We developed a pipeline for ingesting, harmonizing, and centralizing data from 56 contributing data partners using four federated Common Data Models. N3C Data quality (DQ) review involves both automated and manual procedures. In the process, several DQ heuristics were discovered in our centralized context, both within the pipeline and during downstream project-based analysis. Feedback to the sites led to many local and centralized DQ improvements. Results Beyond well-recognized DQ findings, we discovered 15 heuristics relating to source CDM conformance, demographics, COVID tests, conditions, encounters, measurements, observations, coding completeness and fitness for use. Of 56 sites, 37 sites (66%) demonstrated issues through these heuristics. These 37 sites demonstrated improvement after receiving feedback. Discussion We encountered site-to-site differences in DQ which would have been challenging to discover using federated checks alone. We have demonstrated that centralized DQ benchmarking reveals unique opportunities for data quality improvement that will support improved research analytics locally and in aggregate. Conclusion By combining rapid, continual assessment of DQ with a large volume of multi-site data, it is possible to support more nuanced scientific questions with the scale and rigor that they require.
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Importance The National COVID Cohort Collaborative (N3C) is a centralized, harmonized, high-granularity electronic health record repository that is the largest, most representative COVID-19 cohort to date. This multicenter data set can support robust evidence-based development of predictive and diagnostic tools and inform clinical care and policy. Objectives To evaluate COVID-19 severity and risk factors over time and assess the use of machine learning to predict clinical severity. Design, Setting, and Participants In a retrospective cohort study of 1 926 526 US adults with SARS-CoV-2 infection (polymerase chain reaction >99% or antigen <1%) and adult patients without SARS-CoV-2 infection who served as controls from 34 medical centers nationwide between January 1, 2020, and December 7, 2020, patients were stratified using a World Health Organization COVID-19 severity scale and demographic characteristics. Differences between groups over time were evaluated using multivariable logistic regression. Random forest and XGBoost models were used to predict severe clinical course (death, discharge to hospice, invasive ventilatory support, or extracorporeal membrane oxygenation). Main Outcomes and Measures Patient demographic characteristics and COVID-19 severity using the World Health Organization COVID-19 severity scale and differences between groups over time using multivariable logistic regression. Results The cohort included 174 568 adults who tested positive for SARS-CoV-2 (mean [SD] age, 44.4 [18.6] years; 53.2% female) and 1 133 848 adult controls who tested negative for SARS-CoV-2 (mean [SD] age, 49.5 [19.2] years; 57.1% female). Of the 174 568 adults with SARS-CoV-2, 32 472 (18.6%) were hospitalized, and 6565 (20.2%) of those had a severe clinical course (invasive ventilatory support, extracorporeal membrane oxygenation, death, or discharge to hospice). Of the hospitalized patients, mortality was 11.6% overall and decreased from 16.4% in March to April 2020 to 8.6% in September to October 2020 (P = .002 for monthly trend). Using 64 inputs available on the first hospital day, this study predicted a severe clinical course using random forest and XGBoost models (area under the receiver operating curve = 0.87 for both) that were stable over time. The factor most strongly associated with clinical severity was pH; this result was consistent across machine learning methods. In a separate multivariable logistic regression model built for inference, age (odds ratio [OR], 1.03 per year; 95% CI, 1.03-1.04), male sex (OR, 1.60; 95% CI, 1.51-1.69), liver disease (OR, 1.20; 95% CI, 1.08-1.34), dementia (OR, 1.26; 95% CI, 1.13-1.41), African American (OR, 1.12; 95% CI, 1.05-1.20) and Asian (OR, 1.33; 95% CI, 1.12-1.57) race, and obesity (OR, 1.36; 95% CI, 1.27-1.46) were independently associated with higher clinical severity. Conclusions and Relevance This cohort study found that COVID-19 mortality decreased over time during 2020 and that patient demographic characteristics and comorbidities were associated with higher clinical severity. The machine learning models accurately predicted ultimate clinical severity using commonly collected clinical data from the first 24 hours of a hospital admission.
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Objective To evaluate the completeness of diagnosis recording in problem lists in a hospital electronic health record (EHR) system during the COVID-19 pandemic Design Retrospective chart review with manual review of free text electronic case notes Setting Major teaching hospital trust in London, one year after the launch of a comprehensive EHR system (Epic), during the first peak of the COVID-19 pandemic in the UK. Participants 516 patients with suspected or confirmed COVID-19 Main outcome measures Percentage of diagnoses already included in the structured problem list Results Prior to review, these patients had a combined total of 2841 diagnoses recorded in their EHR problem lists. 1722 additional diagnoses were identified, increasing the mean number of recorded problems per patient from 5.51 to 8.84. The overall percentage of diagnoses originally included in the problem list was 62.3% (2841 / 4563, 95% confidence interval 60.8%, 63.7%). Conclusions Diagnoses and other clinical information stored in a structured way in electronic health records is extremely useful for supporting clinical decisions, improving patient care and enabling better research. However, recording of medical diagnoses on the structured problem list for inpatients is incomplete, with almost 40% of important diagnoses mentioned only in the free text notes.
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Background: The COVID-19 pandemic has placed an unprecedented strain on health systems, with rapidly increasing demand for healthcare in hospitals and intensive care units (ICUs) worldwide. As the pandemic escalates, determining the resulting needs for healthcare resources (beds, staff, equipment) has become a key priority for many countries. Projecting future demand requires estimates of how long patients with COVID-19 need different levels of hospital care. Methods: We performed a systematic review of early evidence on length of stay (LoS) of patients with COVID-19 in hospital and in ICU. We subsequently developed a method to generate LoS distributions which combines summary statistics reported in multiple studies, accounting for differences in sample sizes. Applying this approach, we provide distributions for total hospital and ICU LoS from studies in China and elsewhere, for use by the community. Results: We identified 52 studies, the majority from China (46/52). Median hospital LoS ranged from 4 to 53 days within China, and 4 to 21 days outside of China, across 45 studies. ICU LoS was reported by eight studies-four each within and outside China-with median values ranging from 6 to 12 and 4 to 19 days, respectively. Our summary distributions have a median hospital LoS of 14 (IQR 10-19) days for China, compared with 5 (IQR 3-9) days outside of China. For ICU, the summary distributions are more similar (median (IQR) of 8 (5-13) days for China and 7 (4-11) days outside of China). There was a visible difference by discharge status, with patients who were discharged alive having longer LoS than those who died during their admission, but no trend associated with study date. Conclusion: Patients with COVID-19 in China appeared to remain in hospital for longer than elsewhere. This may be explained by differences in criteria for admission and discharge between countries, and different timing within the pandemic. In the absence of local data, the combined summary LoS distributions provided here can be used to model bed demands for contingency planning and then updated, with the novel method presented here, as more studies with aggregated statistics emerge outside China.
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Objectives Electronic health record (EHR) data aggregated from multiple, non-affiliated, sources provide an important resource for biomedical research, including digital phenotyping. Unlike work with EHR data from a single organization, aggregate EHR data introduces a number of analysis challenges. Materials and Methods We used the Cerner Health Facts data, a de-identified aggregate EHR data resource populated by data from 100 independent health systems, to investigate the impact of EHR implementation factors on the aggregate data. These included use of ancillary modules, data continuity, International Classification of Disease (ICD) version and prompts for clinical documentation. Results and Discussion Health Facts includes six categories of data from ancillary modules. We found of the 664 facilities in Health Facts, 49 use all six categories while 88 facilities were not using any. We evaluated data contribution over time and found considerable variation at the health system and facility levels. We analyzed the transition from ICD-9 to ICD-10 and found that some organizations completed the shift in 2014 while others remained on ICD-9 in 2017, well after the 2015 deadline. We investigated the utilization of “discharge disposition” to document death and found inconsistent use of this field. We evaluated clinical events used to document travel status implemented in response to Ebola, height and smoking history. Smoking history documentation increased dramatically after Meaningful Use, but dropped in some organizations. These observations highlight the need for any research involving aggregate EHR data to consider implementation factors that contribute to variability in the data before attributing gaps to “missing data.”
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Background The length of stay (LOS) is an important indicator of the efficiency of hospital management. Reduction in the number of inpatient days results in decreased risk of infection and medication side effects, improvement in the quality of treatment, and increased hospital profit with more efficient bed management. The purpose of this study was to determine which factors are associated with length of hospital stay, based on electronic health records, in order to manage hospital stay more efficiently. Materials and methods Research subjects were retrieved from a database of patients admitted to a tertiary general university hospital in South Korea between January and December 2013. Patients were analyzed according to the following three categories: descriptive and exploratory analysis, process pattern analysis using process mining techniques, and statistical analysis and prediction of LOS. Results Overall, 55% (25,228) of inpatients were discharged within 4 days. The department of rehabilitation medicine (RH) had the highest average LOS at 15.9 days. Of all the conditions diagnosed over 250 times, diagnoses of I63.8 (cerebral infarction, middle cerebral artery), I63.9 (infarction of middle cerebral artery territory) and I21.9 (myocardial infarction) were associated with the longest average hospital stay and high standard deviation. Patients with these conditions were also more likely to be transferred to the RH department for rehabilitation. A range of variables, such as transfer, discharge delay time, operation frequency, frequency of diagnosis, severity, bed grade, and insurance type was significantly correlated with the LOS. Conclusions Accurate understanding of the factors associating with the LOS and progressive improvements in processing and monitoring may allow more efficient management of the LOS of inpatients.
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Objective To assess and compare electronic health record (EHR) documentation of chronic disease in problem lists and encounter diagnosis records among Community Health Center (CHC) patients. Materials and methods We assessed patient EHR data in a large clinical research network during 2012–2019. We included CHCs who provided outpatient, older adult primary care to patients age ≥45 years, with ≥2 office visits during the study. Our study sample included 1 180 290 patients from 545 CHCs across 22 states. We used diagnosis codes from 39 Chronic Condition Warehouse algorithms to identify chronic conditions from encounter diagnoses only and compared against problem list records. We measured correspondence including agreement, kappa, prevalence index, bias index, and prevalence-adjusted bias-adjusted kappa. Results Overlap of encounter diagnosis and problem list ascertainment was 59.4% among chronic conditions identified, with 12.2% of conditions identified only in encounters and 28.4% identified only in problem lists. Rates of coidentification varied by condition from 7.1% to 84.4%. Greatest agreement was found in diabetes (84.4%), HIV (78.1%), and hypertension (74.7%). Sixteen conditions had <50% agreement, including cancers and substance use disorders. Overlap for mental health conditions ranged from 47.4% for anxiety to 59.8% for depression. Discussion Agreement between the 2 sources varied substantially. Conditions requiring regular management in primary care settings may have a higher agreement than those diagnosed and treated in specialty care. Conclusion Relying on EHR encounter data to identify chronic conditions without reference to patient problem lists may under-capture conditions among CHC patients in the United States.
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Background Physician-to-physician variation in electronic health record (EHR) documentation not driven by patients’ clinical status could be harmful. Objective Measure variation in completion of common clinical documentation domains. Identify perceived causes and effects of variation and strategies to mitigate negative effects. Design Sequential, explanatory, mixed methods using log data from a commercial EHR vendor and semi-structured interviews with outpatient primary care practices. Participants Quantitative: 170,332 encounters led by 809 physicians in 237 practices. Qualitative: 40 interviewees in 10 practices. Main Measures Interquartile range (IQR) of the proportion of encounters in which a physician completed documentation, for each documentation category. Multilevel linear regression measured the proportion of variation at the physician level. Key Results Five clinical documentation categories had substantial and statistically significant (p < 0.001) variation at the physician level after accounting for state, organization, and practice levels: (1) discussing results (IQR = 50.8%, proportion of variation explained by physician level = 78.1%); (2) assessment and diagnosis (IQR = 60.4%, physician-level variation = 76.0%); (3) problem list (IQR = 73.1%, physician-level variation = 70.1%); (4) review of systems (IQR = 62.3%, physician-level variation = 67.7%); and (5) social history (IQR = 53.3%, physician-level variation = 62.2%). Drivers of variation from interviews included user preferences and EHR designs with multiple places to record similar information. Variation was perceived to create documentation inefficiencies and risk patient harm due to missed or misinterpreted information. Mitigation strategies included targeted user training during EHR implementation and practice meetings focused on documentation standardization. Conclusions Physician-to-physician variation in EHR documentation impedes effective and safe use of EHRs, but there are potential strategies to mitigate negative consequences.
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Electronic health records (EHR)-discontinuity, i.e., having medical information recorded outside of the study EHR system, is associated with substantial information bias in EHR-based comparative effectiveness research (CER). We aimed to develop and validate a prediction model identifying patients with high EHR-continuity to reduce this bias. Based on 183,739 patients aged ≥65 in EHRs from two US provider networks linked with Medicare claims data from 2007-2014, we quantified EHR-continuity by Mean Proportion of Encounters Captured (MPEC) by the EHR system. We built a prediction model for MPEC using one EHR systems as training and the other as validation set. Patients with top 20% predicted EHR-continuity had 3.5-5.8 fold smaller misclassification of 40 CER-relevant variables, compared to the remaining study population. The comorbidity profiles did not differ substantially by predicted EHR-continuity. These findings suggest restriction of CER to patients with high predicted EHR-continuity may confer a favorable validity to generalizability trade-off. This article is protected by copyright. All rights reserved.