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Health records are classified as primary or secondary records. Why is this the case? Then, relate this to the clinical data in a patient’s chart. What is the correlation? Give an example of each.
1) With the growing availability of large electronic health
record(EHR) databases, clinical researchers are increasingly
interested in the secondary use of clinical data. While the
prospective collection of data is notoriously expensive and time
consuming, the use of an EHR may allow a medical institution to
develop a clinical data repository containing extensive records for
large numbers of patients, thereby enabling more efficient
retrospective research. These data are a promising resource for
comparative effectiveness research, outcomes research,
epidemiology, drug surveillance, and public health research.
Unfortunately, EHR data are known to suffer from a variety of
limitations and quality problems. The presence of incomplete
records has been especially well documented. The availability of an
electronic record for a given patient does not mean that the record
contains sufficient information for a given research task.Data
completeness has been explored in some depth. The statistics
community has focused extensively on determining in what manner
data are missing. Specifically, data may be considered to be
missing at random, missing completely at random, or missing not at
random. Datasets that meet these descriptions require different
methods of imputation and inference.The statistical view of missing
or incomplete data, however, is not sufficient for capturing the
complexities of EHR data. EHR records are different from research
data in their methods of collection, storage, and structure. A
clinical record is likely to contain extensive narrative text,
redundancies (i.e., the same information is recorded in multiple
places within a record), and complex longitudinal information.
While traditional research datasets may suffer from some degree of
incompleteness, they are unlikely to reflect the broad systematic
biases that can be introduced by the clinical care process.There
are several dimensions to EHR data completeness. First, the object
of interest can be seen as the patient or as the health care
process through which the patient was treated; there is a
difference between complete information about the patient versus
complete information about the patient’s encounters. A patient with
no health care encounters and an empty record has a complete record
with respect to the health care process, but a blank one with
respect to the patient. Furthermore, one can measure completeness
at different granularities: the record as a whole or of logical
components of the record, each of which may have its own
requirements or expectations (e.g., demographic patient information
versus the physician thought process). Another dimension of
completeness emerges from the distinction between intrinsic and
extrinsic data requirements. One can imagine defining minimum
information requirements necessary to consider a record complete
(which could be with respect to either the patient or the health
care process), or one can tailor the measurement of completeness to
the intended use. Put another way, we can see completeness in terms
of intrinsic expectations (i.e., based a priori upon the content)
or extrinsic requirements (based upon the use).The EHR data
consumers who define these extrinsic requirements will have
different data needs, which will in turn dictate different
conceptualizations of a complete patient record. Here, Juran’s
definition of quality becomes valuable: 'fitness for use'. It may
be that data completeness does not have a simple, objective
definition, but is instead task-dependent. Wang and Strong, for
example, in their work developing a model of data quality, define
completeness as the extent to which data are of sufficient breadth,
depth, and scope for the task at hand. In other words, whether a
dataset is complete or not depends upon that dataset’s intended use
or desired characteristics. In order to determine the number of
complete records available for analysis one must first determine
what it means to have a complete patient record. The quality of a
dataset can only be assessed once the data quality features of
interest have been identified and the concept of data quality
itself has been defined.Multiple interpretations of EHR
completeness, in turn, may result in different subsets of records
that are determined to be complete. The relationships between
research task, completeness definition, and completeness findings,
however, are rarely made explicit. Hogan and Wagner offer one of
the most widely used definitions: the proportion of observations
that are actually recorded in the system. This definition does not,
however, offer specific measures for determining whether a record
is complete. Neither does it account for the possibility that
completeness may be task dependent. What proportion of observations
should be present? Which observations are desired? Are there any
other considerations beyond simple proportion? Furthermore,
observations are complex, nested concepts, and it must be
determined what level of detail or granularity is needed or
expected. In order of increasing detail, one could record a visit
that occurred, the diagnoses, all the symptoms, a detailed
accounting of the timing of all the symptoms, the clinician's
thought process in making a diagnosis, etc.In the sections below,
we enumerate four specific operational and measurable definitions
of completeness. These definitions are not exhaustive, but they
illustrate the diversity of possible meanings of EHR data
completeness. We ran the definitions against our clinical database
in order to demonstrate the magnitude of completeness in the
database and to illustrate the degree of overlap among the
definitions.
Materials and methods :-
Previously, we conducted a systematic review of the literature
on EHR data quality in which we identified five dimensions of data
quality that are of interest to clinical researchers engaged in the
secondary use of EHR data. Completeness was the most commonly
assessed dimension of data quality in the set of articles we
reviewed. Based upon this exploration of the literature on EHR data
quality, consideration of potential EHR data reuse scenarios, and
discussion with stakeholders and domain experts, we describe four
prototypical definitions of completeness that represent a
conceptual model of EHR completeness. Further definitions of
completeness are possible and may become apparent as the reuse of
EHR data becomes more common and more use cases and user needs are
identified.presents a visual model of the four definitions of
completeness, which are described further in Section.
Documentation: a record contains all observations made about a
patient.The most basic definition of a complete patient record
described in the literature is one where all observations made
during a clinical encounter are recorded. This is an objective,
task independent view of completeness that is, in essence, a
measure of the fidelity of the documentation process. Assessments
of documentation completeness rely upon the presence of a reference
standard, which may be drawn from contacting the treating
physician, observations of the clinical encounter or comparing the
EHR data to an alternate trusted data source often a concurrently
maintained paper record. Documentation :-completeness is also
relevant to the quality measurements employed by the Centers for
Medicare & Medicaid Services.In secondary use cases, however,
the data consumer may be uninterested in the documentation process.
Instead, completeness is determined according to how well the
available data match the specific requirements of the task at hand,
meaning that completeness in these situations is more often
subjective and task dependent. While documentation completeness is
intrinsic, the following three definitions of completeness are
extrinsic and can only be applied once a research task has been
identified.Breadth: a record contains all desired types of
data.Some secondary use scenarios require the availability of
multiple types of data. EHR-based cohort identification and
phenotyping, for example, often utilize some combination of
diagnoses, laboratory results, medications, and procedure codes.
Quality of care and clinician performance assessment also rely upon
the presence of multiple data types within the EHR (the relevant
data types vary depending upon clinical area). More broadly,
researchers interested in clinical outcomes may require more than
one type of data to properly capture the clinical state of
patients. In the above cases, therefore, a complete record may be
one where a breadth of desired data types is present. It is
important to note that the absence of a desired data type in a
record does not necessarily indicate a failure in the clinical care
process or in the recording process. Rather, it may be that a data
type that is desired for research was not relevant from a clinical
standpoint, and therefore was not observed.Density: a record
contains a specified number or frequency of data points over
time.In many secondary use scenarios, EHR data consumers require
not only a breadth of data types, but also sufficient numbers and
density of data points over time. Some of the phenotyping
algorithms developed by the eMERGE Network, for example, rely upon
the presence of multiple instances of the same laboratory tests,
diagnoses or medications and sometimes specify desired time periods
between the recording of these data within the EHR. Clinical trial
eligibility criteria, which can be compared to patient records to
identify relevant cohorts, also contain complex temporal data
specifications, as do EHR data requests submitted by clinical
researchers. Breadth and density can be considered complementary,
orthogonal dimensions of completeness. A single point of patient
data, for example, has breadth and density of one.Predictive: a
record contains sufficient information to predict a phenomenon of
interest.Our final and most complex definition of EHR data
completeness arises when one considers that the overall goal of
much research is the ability to predict an outcome. It is possible
to train various computational models, some of which being more
tolerant of missing data than others, using EHR-derived datasets.
Researchers may be interested in predicting, amongst other clinical
phenomena, disease status and risk, readmission or mortality.
Depending upon the model employed, data needs may be implicit,
rather than explicit. The metric for completeness is performance on
the task, rather than counts of data points. The data that are
required are those that are sufficient to make a
prediction.Therefore, it may that two records with different data
profiles are both complete according to this definition.
2) A health record is a confidential compilation of pertinent
facts of an individual's health history, including all past and
present medical conditions, illnesses and treatments, with emphasis
on the specific events affecting the patient during the current
episode of care.Example is EHRs include information like your age,
gender,ethnicity, health history, medicines, allergies,
immunization status, lab test results, hospital discharge
instructions, and billing information.Whereas, A medical chart is a
complete record of a patient's key clinical data and medical
history, such as demographics, vital signs, diagnoses,
medications,treatment plans, progress notes,problems, immunization
dates, allergies, radiology images, and laboratory and test
results.Example is the data collected includes administrative and
demographic information, diagnosis, treatment, prescription drugs,
laboratory tests, physiologic monitoring data, hospitalization,
patient insurance, etc. Individual organizations such as hospitals
or health systems may provide access to internal staff.