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Medication related computerized decision support system (CDSS): make it a clinicians' partner!

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Medication related Computerized Decision Support System (CDSS) are known to have a positive impact on Adverse Drug Events (ADE) prevention but they face acceptance problems due to over alerting and usability issues. We present here a Human factors approach to the design of these Clinical Decision Support (CDS) functions and to their integration into different Electronic Health Record (EHR) / Computerized Physicians Order Entry (CPOE) systems, so that the resulting CDSS corresponds to the users needs and fits clinical workflows and cognitive processes. We used ethnographic observations completed with semi-structured interviews to analyse existing work situations and work processes. These were then described in detail using the SHEL (Software, Hardware, Environment & Liveware) formalism, which enables a structured description of the work system and provides an appropriate classification of human errors potentially leading to ADEs. We then propose a Unified Modelling Language (UML) model supporting the characterization by the CDSS of the drug monitoring and clinical context of patients at risk of ADE. This model combines the status of the lab test orders on the one hand with the validity and normality of the lab results on the other hand. This makes the system able to catch the context of the monitoring of the drugs through their corresponding lab tests and lab results (e.g. kalemia for potassium) and also part of the context of the clinical status of the patient (actual lab values, but also diseases and other pathologies that are identified as potential causes of the ADE e.g. renal insufficiency and potassium). We show that making the system able to catch the monitoring and clinical contexts opens interesting opportunities for the design of the CDS information content and display mode. Implementing this model would allow the CDSS to take into account the actions already engaged by the healthcare team and to adapt the information delivered to the monitoring and clinical context, thus making the CDSS a partner to the clinicians, nurses and pharmacists.
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Medication Related Computerized
Decision Support System (CDSS): Make it
a Clinicians’ Partner!
Romaric MARCILLY a,1, Nicolas LEROY a, Michel LUYCKX b, c, Sylvia PELAYO a,
Costanza RICCIOLI d and Marie-Catherine BEUSCART-ZÉPHIR a
a
INSERM CIC-IT, Lille, CHU Lille; UDSL EA 2694; Univ Lille Nord de France;
F-59000 Lille, France
b Faculté des Sciences Pharmaceutiques et Biologiques, UDSL2, Univ Lille Nord de
France, F-59000 Lille, France
c Centre Hospitalier de Denain, France
d
Kite Solutions, SNC, Via Labiena 93, 21014 Laveno Mombello (Va), Italy
Abstract. Medication related Computerized Decision Support System (CDSS) are
known to have a positive impact on Adverse Drug Events (ADE) prevention but
they face acceptance problems due to over alerting and usability issues. We
present here a Human factors approach to the design of these Clinical Decision
Support (CDS) functions and to their integration into different Electronic Health
Record (EHR) / Computerized Physicians Order Entry (CPOE) systems, so that
the resulting CDSS corresponds to the users needs and fits clinical workflows and
cognitive processes. We used ethnographic observations completed with semi-
structured interviews to analyse existing work situations and work processes.
These were then described in detail using the SHEL (Software, Hardware,
Environment & Liveware) formalism, which enables a structured description of
the work system and provides an appropriate classification of human errors
potentially leading to ADEs. We then propose a Unified Modelling Language
(UML) model supporting the characterization by the CDSS of the drug monitoring
and clinical context of patients at risk of ADE. This model combines the status of
the lab test orders on the one hand with the validity and normality of the lab results
on the other hand. This makes the system able to catch the context of the
monitoring of the drugs through their corresponding lab tests and lab results (e.g.
kalemia for potassium) and also part of the context of the clinical status of the
patient (actual lab values, but also diseases and other pathologies that are identified
as potential causes of the ADE e.g. renal insufficiency and potassium). We show
that making the system able to catch the monitoring and clinical contexts opens
interesting opportunities for the design of the CDS information content and display
mode. Implementing this model would allow the CDSS to take into account the
actions already engaged by the healthcare team and to adapt the information
delivered to the monitoring and clinical context, thus making the CDSS a partner
to the clinicians, nurses and pharmacists.
Keywords. Computerized decision support systems, clinical decision support,
human factors engineering, adverse drug events, system design
1 Corresponding Author: romaric.marcilly@univ-lille2.fr
Patient Safety Informatics
V. Koutkias et al. (Eds.)
IOS Press, 2011
© 2011 The authors and IOS Press. All rights reserved.
doi:10.3233/978-1-60750-740-6-84
84
Introduction
Adverse Drug Events (ADE) are the most common Adverse Events occurring during
the care process [1]. These ADEs result in human costs in terms of patients’ deaths or
injuries and economic costs in terms of hospital prolonged stays or lawsuits. Therefore,
many countries consider ADEs to be a major public health issue and currently invest a
lot of resources in patient safety programs aiming at identifying, characterizing and
preventing ADEs. One way among many to prevent ADEs is to implement medication
related Clinical Decision Support (CDS) functions, usually integrated in or interfaced
with Computerized Physicians Order Entry applications (CPOE). These systems
support physicians’ therapeutic decision by checking the orders against a medication
knowledge base providing alerts or suggestions to the prescribers. As a result,
physicians can adjust their decision according to the known side effects of the drugs,
their interactions and potential contra-indications. Kuperman et al. [2] identify two
categories of medication CDS. Basic CDS includes drug-allergy checking, basic dosing
guidance, formulary decision support, duplicate therapy checking, and drugdrug
interaction checking, while advanced CDS includes dosing support for renal
insufficiency and geriatric patients, guidance for medication-related laboratory testing,
drugdisease contraindication checking, and drugpregnancy checking. Despite some
acceptance and usage problems [3], the implementation and use of medication related
CDSS have been found to be beneficial in improving the quality of clinicians
prescriptions and reducing medication errors [4-5] and ultimately preventing ADEs [6].
Therefore it seems worth pursuing the efforts in designing and developing acceptable,
user centred advanced medication CDSS applications.
1. Background
1.1. Scope of the Study
The present study is part of the European project entitled “Patient Safety through
Intelligent Procedures in medication-PSIP”. The first goal of the PSIP project is to
automatically generate knowledge about ADEs, therefore providing reliable numbers
about ADEs per country, region, hospital or medical unit, describing their type,
consequences and probable causes. This knowledge about ADEs helps identify
situations at risk in each context of care, depending on the patients’ characteristics, i.e.
medical history and current symptoms, and on the care place, for instance the type of
hospital / medical specialty. The second goal of the PSIP project is to deliver to the
healthcare professionals and to the patients who find themselves in these risky
situations, the contextual knowledge that can help them characterize the problem and
adapt the treatment to avoid potential ADEs.
PSIP addresses a particular subset of preventable ADEs, which according to the
NCCMERP taxonomy [7] may be characterized as “medication monitoring errors”,
with a specific focus on faulty monitoring of clinical or laboratory values. As a
consequence the advanced CDS functions developed in PSIP result mainly in Drug-
Laboratory alerts and Drug-Condition/Disease/Age alerts.
The project adopts a user centred / user driven approach to the design of these CDS
functions and to their integration into different EHR (Electronic Health Record) /
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS) 85
CPOE systems, so that the resulting CDSS corresponds to the users needs and fits
clinical workflows and cognitive processes.
1.2. Human Factors Limitations of Current Medication CDSS
In spite of their known positive impact, medication CDSS applications remain difficult
to implement and face acceptance problems [3, 8]. These difficulties are due to a
combination of human factors related drawbacks of current systems.
The major drawback of existing systems is undoubtedly their poor signal-to-noise
ratio [9-10]. This problem generates a well known “over-alerting” syndrome due to too
many false positives which in turn engenders “alert fatigue” for the prescribing
physicians. Alert fatigue is “the mental state that is the result of too many alerts
consuming time and energy” [9]. Moreover, the fact that a number of “alerts” are
clinically irrelevant [11] diminishes the clinicians’ confidence in the system. Reducing
over-alerting is therefore one of the major challenges for the design of a medication
CDSS. This question points at the quality and the completeness of the knowledge
implemented in the knowledge base of the medication CDSS and at its ability to catch
and take into account the clinical context of the patient at hand. The PSIP system partly
addresses this issue by contextualizing the alerts depending on the probability of
occurrence of the ADEs per hospital, per clinical unit or medical specialty [12].
However, it is unreasonable to think that a CDSS might incorporate a “perfect” (i.e.
accurate and exhaustive) knowledge so that it would be able to identify and take into
account all relevant characteristics of the clinical case at hand and eradicate the over
alerting. Ultimately, only the clinician is able to gather the relevant clinical
information, assess it and finally make the therapeutic decision. Therefore, no
medication CDSS will ever be “perfect” enough so as to act as a substitute to the
clinicians and fully automate the therapeutic decision making. As a consequence, it is
necessary that the CDS functions support and not replace the clinician’s decision and
act as a partner to her/his medical reasoning and decision making cognitive process.
The second drawback of many existing systems is their poor usability [ 13]. On a
fundamental level, the model of work and the model of clinicians’ reasoning
incorporated in the systems are often inadequate. This usability weakness issues
“compatibility” problems defined as a lack of match between users’ and task
characteristics on the one hand, and the organisation of the output, input, and dialogue
for a given application, on the other hand [14]. As a consequence, alerts are too often
disruptive of the clinical workflows and of the cognitive processes inherent to
medication decision making and monitoring, due to wrong timing, wrong display mode
and wrong/weak content of the information delivered. For example, it is not wise to
suggest to the physician an action s/he is just about to carry out [15], or to alert him/her
on a potentially dangerous situation for which s/he has just taken action by ordering the
corresponding lab tests. All physicians dislike such alerts which they find unnerving.
Moreover, most of the systems fail to make available upon request short or extended
versions of the scientific justifications of the CDS recommendations, which are
necessary to allow the physicians properly assessing their clinical relevance and the
resulting cost-benefit of the medication order for the patient under consideration.
Given the nature of the difficulties and usability issues, a Human Factors
Engineering [16] approach to the design of advanced medication CDS functions would
help solve a part of those problems and contribute to the design of applications acting
as effective and reliable clinicians partners.
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS)86
1.3. The Human Factors Engineering (HFE) Approach to the Design of Advanced
Medication CDS Functions
A Human Factors Engineering approach to healthcare work systems aims at optimizing
the relationships between the users, their tasks and the technologies they use to carry
out these tasks in various work environments and organizations. It requires a user-
centred approach to the design of the IT applications, taking into account the needs,
expectations and characteristics of the end users, who need to be actually involved in
the design process. This approach would help design effective and usable medication
CDSS. The most important phase in the HFE approach is the initial one, i.e. the
observation, analysis and modelling of the existing work system. It is therefore
important to retrieve and use the knowledge on the work system accumulated in
previous HF studies on the medication use process in hospital settings [17-18]. These
studies have already provided valuable insights on the intangible characteristics of the
clinical workflows and of the healthcare professionals’ decision making process. The
results emphasize the fact that therapeutic decision making is a dynamic process [19]:
the patient’s condition evolves depending on the healthcare professionals’ actions but
also spontaneously by itself. At each encounter with the patient, clinicians have to
update their knowledge about the patient’s status and his/her evolution, especially as
regards new important elements in the situation, e.g. new lab results or unexpected
clinical evolution of the patient [20]. Moreover, the medication use process is
characterized as a complex distributed work situation: the information is distributed
across the minds of the members of the clinical team but also across physical media,
such as the EHR, the CPOE or the CDSS [21]. These disparate pieces of information
should then be integrated, completed, and interpreted. From the users’ point of view,
the collection, documentation, communication, and retrieval of information are critical
activities.
In the present study, we elaborated on this existing knowledge and completed
previous field studies and analyses by focused observations and modelling of the
monitoring process of patients’ therapeutic treatments based mainly on corresponding
lab values. The objectives of this research are to:
Identify the relevant indicators of the context of lab values based monitoring
of the drug,
identify the relevant indicators of the context of the clinical status of the
patients that may have an impact on the considered ADE, i.e. actual lab values
and eventually other diseases inferred from lab results such as renal
insufficiency, and
elaborate a model supporting the implementation in the CDSS of functions
able to reflect these clinical and monitoring contexts.
2. Methods
2.1. Study Site
The study took place in a 416-bed hospital, the Hospital Center of Denain in northern
France. The hospital has a Patient Care Information system (PCIS), the commercial
product DxCare® from the MEDASYS Company. It includes an EHR equipped with a
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS) 87
CPOE which in this version has very limited CDS functions (e.g. alerts in case of
duplicates). The PCIS is interfaced with a pharmacy system, which allows the
pharmacists to check the medication orders and send physicians alerts when they
suspect improper orders. The analyses were carried out in two medicine departments:
the cardiology department (medicine A) and the “internal medicine and infectious
diseases” department (medicine B).
2.2. HFE Methods
2.2.1. On Site Observations and Interviews
Over a period of one month (May-June 2009), four HF experts observed all tasks
related to the medication process carried out by 4 physicians, 6 nurses, 2 pharmacists
and 2 assistant pharmacists, with a special focus on all actions related to lab values
monitoring. Observation time amounted to 53 hours and concerned 101 different
patients. Observations were completed with debriefings and semi-structured interviews
to clarify actors’ goals, thought processes and information needs while monitoring lab
values and patients’ treatments. Detailed description of methods can be found in [22].
2.2.2. Structured Analysis of Data and Modelling
We used the SHEL (Software, Hardware, Environment & Liveware) formalism to
describe the data collected. Originally developed for the aviation domain [23], SHEL
aims at representing working contexts and main actors while specifically identifying
existing barriers against errors. It enables a structured description of the work system
and provides an appropriate classification of human errors potentially leading to ADEs.
Given the objective of the project, i.e. to design medication CDS functions, this
formalism is particularly appropriate because it helps designing a system enhancing
and completing existing barriers thus acting as a professionals partner.
We also used Unified Modelling Language (UML) to express the HF
recommendations as this language has been shown to facilitate the dialogue between
HF experts and computer scientists (designers and developers) [24].
3. Results
3.1. Results of the Analysis of the Work Situation
The analysis of the data collected during the field observations issued twelve SHEL
descriptions of the various tasks performed by all actors during the medication use
process or related to it. For illustration purposes Figure 1 provides a SHEL overview of
the survey by the physicians of the patient therapeutic treatment during the daily
medical round, focused on information gathering activities.
Once the main SHEL elements have been identified, it is possible to describe the
interactions between the four dimensions, in order to get a full picture of the work
system. SHEL also allows identifying existing barriers to errors. For the example
described above, barriers would help the physician not to overlook important
information that should be taken into account to adapt the patient’s treatment.
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS)88
Survey by the physicians of the
patient therapeutic treatment
during the daily medical round,
focused on information
gathering activities.
The main objective of the physician is to retrieve
and check all new relevant information or data
about the patient:
Look for recent data in the patients record, i.e.
data received after the last encounter with this
patient or after the last check of the patients data.
Check nursestransmissions and/or ask them about
the recent patientsclinical evolutions
Carry out clinical interview and clinical exam of
the patient
S
OFTWARE
[work procedures]
EHR and CPOE (description of available screens
and their information content)
Paper documents (e.g. received faxes, or letters,
post-its or informal written notes, etc.)
Fax
Telephone
H
ARDWARE
[tools supporting the activities]
Corridor
Patient room
Nursing room
E
NVIRONMENT
[locations where the actions take place]
Clinicians
Nurses
Patient
Laboratory people
Pharmacist
L
IVEWARE
[people interacting for this particular task]
Survey by the physicians of the
patient therapeutic treatment
during the daily medical round,
focused on information
gathering activities.
The main objective of the physician is to retrieve
and check all new relevant information or data
about the patient:
Look for recent data in the patients record, i.e.
data received after the last encounter with this
patient or after the last check of the patients data.
Check nursestransmissions and/or ask them about
the recent patientsclinical evolutions
Carry out clinical interview and clinical exam of
the patient
S
OFTWARE
[work procedures]
EHR and CPOE (description of available screens
and their information content)
Paper documents (e.g. received faxes, or letters,
post-its or informal written notes, etc.)
Fax
Telephone
H
ARDWARE
[tools supporting the activities]
Corridor
Patient room
Nursing room
E
NVIRONMENT
[locations where the actions take place]
Clinicians
Nurses
Patient
Laboratory people
Pharmacist
L
IVEWARE
[people interacting for this particular task]
Figure 1. SHEL overview of the work situation - survey of the patient therapeutic treatment during the daily
medical round.
Examples of such barriers are:
Doctor-nurse communications and nurses’ reminders to physicians
Phone calls or faxes from the laboratory in case of abnormal results. Those
calls are usually received by nurses who then pass on the information to the
physicians
CPOE alerts on new available lab results, i.e. results that have not been yet
acknowledged by a clinician
Patients’ complains
The analysis highlights the close intertwinement between the medications’ use
process and the laboratory ordering and reporting cycle. The dependency between the
drugs administered to the patient and the biological indicator of their effect (i.e. the lab
test result) is time dependant and strongly impacts the work procedures of the nurses
and physicians:
Lab results must be retrieved on time for the physician to be able to decide
how best to adapt the treatment to the patient’s condition.
For certain drugs (e.g. anticoagulant VKA Vitamine K Antagonist) nurses
need to check the last corresponding lab values (e.g. INR-International
Normalized Ratio) before administration. When this information is missing,
nurses may have to take initiatives such as taking a new sample of blood and
ask for urgent results, ordering reconciliation being performed later by the
physician in the CPOE system.
The patient’s state evolving as a result of the medications’ effect but also on
its own, the lab results are valid only for a given time period. This period
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS) 89
depends on the type of medication whose effect must be monitored and also
on the patient’s conditions. Once the validity period elapsed, the lab test must
be re-ordered to get a new (valid) lab result.
The analysis also identifies the fundamental steps through which a healthcare
professional goes when s/he relies on lab values to monitor the impact of a drug:
Check whether the lab result is available or not:
o In case the lab result is not available: check whether the corresponding lab
test is ordered or not
When the lab result is available, check whether it is recent enough to be valid
or not:
o In case the result is not recent enough, check whether the corresponding
lab order has been renewed or not
When the lab result is available, check whether it is normal (within acceptable
limits) or not:
o In case of abnormal results, consider adapting the treatment (modifying
the drug prescription / administration)
3.2. Characterization of the Monitoring and Clinical Context
Relying on the analysis of the work situation and more specifically on the sequence of
actions carried out by healthcare professionals when checking lab values for a given
drug, we identified typical situations characterizing the current status of drug
monitoring. These situations result form the combination of the status of the lab tests
orders on the one hand and the validity and normality of the available lab values on the
other hand. For each typical situation we can identify whether the monitoring
procedure is appropriate or not, and whether the patient’s clinical status, assessed by
the lab value, is alarming or not (yet). Therefore, these situations characterize the lab
value-based monitoring context and a part of the clinical context for the patient under
consideration.
Figure 2 presents the UML model of the classification process to be performed by
the Contextualized Computerized Decision Support System (Cx-CDSS), leading to the
identification of the monitoring and clinical context for the patients identified by the
system as being at risk of an ADE.
For example, Context 3 corresponds to a situation under control: the drug is
properly monitored because the required lab values are available and recent enough to
be considered valid indicators of the patient’s clinical status, and these lab results are in
normal range.
On the contrary, Context 2 corresponds to a situation which is not properly
monitored, because the required lab values are not available and the system cannot find
any corresponding lab test order.
Context 7 is perhaps even more alarming as the system can identify that the last
available lab value was abnormal, but this value is not recent enough to be considered a
valid indicator of the current patient’s clinical state, and the corresponding lab test
order has not been renewed. In this context, the probability of appearance of the
potential ADE is higher but the effect is not likely to be prevented as it is not properly
monitored.
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS)90
Figure 2. UML model supporting the classification of the situations leading to the identification of the eight
relevant monitoring and clinical contexts.
3.3. Recommendations for the Design of the CDS Information Delivered to Healthcare
Professionals
Making the system able to catch the monitoring and clinical contexts opens interesting
opportunities for the design of the CDS information content and display mode.
It is for instance possible to group the contexts in terms of urgency of the situations
and to reflect this degree of urgency in the display mode of the CDS information. All
contexts for which the last lab result available is abnormal (i.e. contexts 6, 7 and 8)
should be considered a priority and given a high “urgency” indicator. Contexts 2 and 4
correspond to situations that are not properly monitored but where no alarming results
have been received yet. For these contexts the information delivered by the CDSS
should be given a medium “urgency” indicator. Finally, contexts 1, 3 and 5 correspond
to situations that are properly monitored because the lab tests have been ordered and
when these lab results are available they are not (yet) abnormal. Therefore, the
information delivered in these situations should be given a low “urgency” rating. The
designers may choose the most appropriate way of indicating the “urgency” rating in
the Human Computer Interface, depending for example on the design chart of the
application (CPOE, EHR) in which the system is integrated.
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS) 91
It is also possible to adapt the content of the information delivered to the clinicians
depending on the context. It is recommended that the CDSS not only displays an alert
but also makes suggestions [2]. In contexts 2, 4 and 7 corresponding to situations that
are not properly monitored, and in addition to the display of the rule leading to the
identification of the case as being at risk of ADE, the CDSS could suggest that the
clinician orders the required lab test and eventually propose a short cut to the lab tests
ordering page. On the contrary context 6, in which a new (recent and valid) lab value
came in abnormal, the system could alert the physician on the increasing negative side
effect of the drug and invite him/her to reassess the cost benefit ratio of the
incriminated drug(s).
Finally advanced parameterization functions based on the identification of the
context could be offered to clinicians, pharmacists and nurses to let them upgrade the
level of urgency if needed for specific ADEs, or to take advantage of the monitoring
protocols adopted in the department
4. Discussion
Making a CDSS able to catch elements of the clinical context is highly desirable goal.
The model proposed in this paper is operational and seems simple enough to be
implemented in any medication CDSS integrated in a CPOE or an EHR. However it
requires the incorporation in the system of specific knowledge, as is illustrated in the
case below.
Example: a patient is identified by the PSIP system by triggering the following
rule:
CDSS rule b011: vitKantagonist + cephalosporin Æ high_inr;
Text of the rule for the physician: “An increased effect of the oral
anticoagulant can occur in an infectious context. Cephalosporins by
themselves may increase hemorrhagic risk. Ref.: Thesaurus AFSSAPS 2009.
In this case the characterization of the monitoring and clinical context would
require the following knowledge to be integrated in the system.
4.1. Identify the Targeted Lab Value
The system has to know what the targeted lab value is for this ADE risk. This
knowledge may be retrieved from the rule itself, i.e. INR (International Normalized
Ratio). However, although international guidelines recommend monitoring VKA
(Vitamin K Antagonist) effect through INR, a number of physicians / laboratories /
hospital departments still rely on other lab values such as aPTT (activated Partial
Thromboplastin Time). This knowledge has to be incorporated to improve the accuracy
of the system and make it able to check for alternative lab tests / values when the
search for INR fails.
4.2. Assess the Lab Value Normality
The system has to know whether the retrieved INR values are “normal” or not. This
knowledge is usually available in the Laboratory Information System as results are
delivered along with normality thresholds and special marks for abnormal results.
R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS)92
4.3. Assess the Lab Value Validity
Finally, the system has to know whether the last available INR value is recent enough
to be considered valid. The knowledge necessary to answer this question is more
complex. For example, chronic patients who have long been on VKA and are stabilized
do not require frequent monitoring (once every two weeks or once a month). But as
soon as the clinical status changes (e.g. infection), or if a new drug is introduced, a
closer monitoring is required, and this is often the case for hospitalized patient.
Similarly, when the VKA treatment is first introduced, a close monitoring is required
until the patient is stabilized. By default, it is usually recommended to test the INR
every 2 days, and this corresponds to the most common VKA monitoring protocol in
hospital departments. This simple, by default knowledge, could be used by the system.
Ultimately a more elaborated knowledge based on the drug’s pharmacodynamics
(elimination half-life of the product) would be more accurate and allow adaptation to
the type of VKA actually prescribed.
This example shows that a basic, operational knowledge based on by default
values and protocols running in the hospitals could be used to support the
characterization of the monitoring and clinical context of patients at risk of ADE. But
further research could progressively elaborate a more accurate and sophisticated
knowledge, therefore improving the efficiency and accuracy of the system.
5. Conclusion
The characterization of the monitoring and clinical context and the advanced functions
they make possible are not currently available in medication related CDSS. Their
implementation would allow the system to take into account the actions already
engaged by the healthcare team and to adapt the information delivered to the
monitoring and clinical context thus making the CDSS a partner to the clinicians,
nurses and pharmacists. They would also probably lessen the burden of over alerting by
allowing the clinicians to identify at a glance the urgency and type of problem
addressed by the alerts.
Acknowledgments
The research leading to these results has received funding from the
European Community’s Seventh Framework Programme
(FP7/2007-2013) under grant agreement n° 216130 the PSIP
project.
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R. Marcilly et al. / Medication Related Computerized Decision Support System (CDSS)94
... In addition, our research elaborated on knowledge sources such as: (a) the literature, i.e. obtaining evidence from either similar statistical analysis performed on clinical data repositories or focused drug-safety related studies [32]; (b) tacit knowledge [33], which was primarily captured in the knowledge elicitation process in which experts validated the data-mining originated rules based on their experiences and specialties, and (c) human factors and clinical procedures analysis, resulting in specifications as regards the logic according to which the ADE signals discovered should be applied in practice for the particular domain context, as well as in recommendations for the CDSS design and functionality [34]. ...
... Such knowledge was initially considered as a means to associate medication issues and other medical conditions with specific steps of the clinical practice and actions. The human factor analysis until now resulted in a set of recommendations for the CDSS design and functionality [34], which would increase the effectiveness of such systems in clinical practice. In this regard, the set of meta-rules was defined providing the logic according to which the ADE rules should be applied in practice in a particular context. ...
Article
The primary aim of this work was the development of a uniform, contextualized and sustainable knowledge-based framework to support adverse drug event (ADE) prevention via Clinical Decision Support Systems (CDSSs). In this regard, the employed methodology involved first the systematic analysis and formalization of the knowledge sources elaborated in the scope of this work, through which an application-specific knowledge model has been defined. The entire framework architecture has been then specified and implemented by adopting Computer Interpretable Guidelines (CIGs) as the knowledge engineering formalism for its construction. The framework integrates diverse and dynamic knowledge sources in the form of rule-based ADE signals, all under a uniform Knowledge Base (KB) structure, according to the defined knowledge model. Equally important, it employs the means to contextualize the encapsulated knowledge, in order to provide appropriate support considering the specific local environment (hospital, medical department, language, etc.), as well as the mechanisms for knowledge querying, inference, sharing, and management. In this paper, we present thoroughly the establishment of the proposed knowledge framework by presenting the employed methodology and the results obtained as regards implementation, performance and validation aspects that highlight its applicability and virtue in medication safety.
... Studies have shown that the SHEL model has been applied to nursing safety management, 18 emergency safety management, surgical patient prevention and control of postoperative infection, and good results have been achieved in improving nurses' safety cognition, nursing service quality and patient satisfaction. [19][20][21] The comparison between before and after the management of respiratory tract exposure in the isolation unit of a Fangcang shelter hospital using the SHEL model showed that the number of people with respiratory tract exposure after its implementation of the SHEL model decreased from nine cases before implementation to two cases afterwards the implementation, with the number significantly reduced. This was similar to the research results of Guo et al. 22 Using the SHEL model to manage the occupational exposure of nurses to the new coronavirus, the number of occupational exposures was reduced from 11 cases before the implementation to 3 cases afterwards the implementation. ...
Article
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Objective To explore the application effect of the (software factors, hardware factors, environmental factors, parties and other factors, SHEL) model in respiratory tract exposure protection of staff in temporary COVID-19 hospitals. Methods 207 Staff members working in the isolation units of Fangcang shelter hospitals between 20 May 2022 and 5 June 2022 were selected as research subjects. The SHEL model was used to protect and manage the respiratory exposure of the isolation unit staff to the novel coronavirus. The incidence of respiratory exposure among the staff in the isolation units was compared before the SHEL model’s implementation (20 May 2022–28 May 2022) and afterwards the SHEL model’s implementation (29 May 2022–5 June 2022). Results Before the implementation of the SHEL model, a total of nine cases (4.35%) from 207 workers had respiratory exposure. Occurrence location: six cases in the isolation room (one-out room, level-one protection zone) and three cases in the drop-off area for patients outside the ward. After implementation, a total of two cases (0.97%) of respiratory tract exposure occurred among the 207 staff members; both occurred in the unprotected zone (two-out room, level-two protection zone), and the difference was statistically significant before and after the implementation (P < 0.05). Conclusion New coronary pneumonia Fangcang shelter hospitals should use the SHEL model to manage the respiratory exposure of their isolation unit staff to reduce the respiratory exposure risk to staff in isolation units.
... However, designing a CDSS for reminding and feedbacks can improve different behaviors of medication management among service providers and patients as this type of CDSS improves prevention and clinical guidelines. According to Marcilly et al. [28], adverse drug events are also the most common adverse events occurring during the care process and can lead to increased hospital stay time and treatment costs, medical complications, and even death. ...
Article
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Coronavirus disease (COVID-19) as an emerging disease decreases security among people from different countries. Sense of security can be raised via quick diagnosis of COVID-19, and its management and control using clinical decision support systems (CDSS) to prevent further spread of the disease. So, the aim of this study is to identify and introduce the applications of a CDSS in the diagnosis, management, and control of COVID-19. This cross-sectional study was conducted to identify and introduce the applications of CDSS in the diagnosis, management, and control of COVID-19. Based on the results of some meetings with infectious disease specialists and a general practitioner as well as reviewing the related literature, information about COVID-19 and CDSS was obtained. Then based on the information obtained, a questionnaire was designed electronically and distributed in a two-round Delphi method among 19 experts in the three fields of medical informatics, health information management, and infectious disease specialists. According to the literature and expert opinions, 35 applications of CDSS applications were identified in the four main groups of "diagnosis", "medication", "monitoring", and "health services". Eventually, a collective agreement was reached on 30 applications in the first and second rounds of Delphi. Among all the applications, the highest means were assigned to "monitoring the vital signs" and "helping diagnose infections and damaged lung tissue through CT scan". Introducing these applications can provide general, basic knowledge of the design and implementation of clinical decision support systems in the real world to prevent irreversible complications and even many people's death.
... In order to decrease over-alerting and alert-fatigue, it has been proposed to improve the way the CDSS interacts with the prescriber, and notably to improve the way the alerts are displayed [4], to provide the users with relevant instructions for post-alert medical management [3,[17][18][19], and to involve non-medical healthcare professionals [6]. Some works also proposed to take into account the context of the drug prescription: userrelated context (task, workflow, knowledge, preferences, medical unit) [2,[20][21][22] and patient-related context (demographic data, risk factors) [3,17,20,21]. The temporal aspects have been identified as an important aspect: half of the prescribing errors occur on the first day of stay [14], the repetition of alerts has to be handled [9,20,21,23], as well as the kinetic of laboratory parameters [24]. ...
Article
Clinical decision support systems (CDSS) fail to prevent adverse drug events (ADE), notably due to over-alerting and alert-fatigue. Many methods have been proposed in the literature to reduce over-alerting of CDSS: enhancing post-alert medical management, taking into account user-related context, patient-related context and temporal aspects, improving medical relevance of alerts, filtering or tiering alerts on the basis of their strength of evidence, their severity, their override rate, or the probability of outcome. This paper analyzes the different options, and proposes the setup of SPC-CDSS (statistically prioritized and contextualized CDSS). The principle is that, when a SPC-CDSS is implemented in a medical unit, it first reuses actual clinical data, and searches for traceable outcomes. Then, for each rule trying to prevent this outcome, the SPC-CDSS automatically estimates the conditional probability of outcome knowing that the conditions of the rule are met, by retrospective secondary use of data. The alert can be turned off below a chosen probability threshold. This probability computation can be performed in each medical unit, in order to take into account its sensitivity to context.
... Further, CDS developers seeking to implement CDS have generally sought end user feedback on clinical content or validation in the form of usability testing following initial CDS design prototyping. [19][20][21][22] Such input after prototyping introduces potential bias in end-user feedback of what the end product could be. While there are published examples of obtaining end-user input into the design of a paper-based CDS prior to prototyping, 23 those results may not apply to electronic CDS workflows. ...
Article
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Background To improve user-centred design efforts and efficiency; there is a need to disseminate information on modern day clinician preferences for technologies such as computerised clinical decision support (CDS). Objective To describe clinician perceptions regarding beneficial features of CDS for chronic medications in primary care. Methods This study included focus groups and clinicians individually describing their ideal CDS. Three focus groups were conducted including prescribing clinicians from a variety of disciplines. Outcome measures included identification of favourable features and unintended consequences of CDS for chronic medication management in primary care. We transcribed recordings, performed thematic qualitative analysis and generated counts when possible. Results There were 21 participants who identified four categories of beneficial CDS features during the group discussion: non-interruptive alerts, clinically relevant and customisable support, presentation of pertinent clinical information and optimises workflow. Non-interruptive alerts were broadly defined as passive alerts that a user chooses to review, whereas interruptive were active or disruptive alerts that interrupted workflow and one is forced to review before completing a task. The CDS features identified in the individual descriptions were consistent with the focus group discussion, with the exception of non-interruptive alerts. In the individual descriptions, 12 clinicians preferred interruptive CDS compared with seven clinicians describing non-interruptive CDS. Conclusion Clinicians identified CDS for chronic medications beneficial when they are clinically relevant and customisable, present pertinent clinical information (eg, labs, vitals) and improve their workflow. Although clinicians preferred passive, non-interruptive alerts, most acknowledged that these may not be widely seen and may be less effective. These features align with literature describing best practices in CDS design and emphasise those features clinicians prioritise, which should be considered when designing CDS for medication management in primary care. These findings highlight the disparity between the current state of CDS design and clinician-stated design features associated with beneficial CDS.
... As discussed by Koutkias et al. (2012), the process of drug Prescribing, Ordering, Dispensing, and Administration can be heavily influenced by human factors. Based on the definition of rules for Clinical Decision-Support System design and functionality, the traditional approach of human factor analysis is considered more suitable (Marcilly et al., 2011). Instead, as a possible development of ADE knowledge engineering, the authors propose the introduction and study of tools to define advanced rules to reduce the negative outcomes of ADEs ascribable to parameters related to human factors. ...
... Secondly, if these requirements are met, it must be defined as to when and how the available context information is taken into account. Marcilly et al. [36] proposed an approach to classify situations related to drug prescription and tried to identify the " right moment " of alerting (for example, do not alert if a drug-related lab value is normal and sufficiently monitored). Further work is essential to putting our still theoretical approach into practice. ...
Article
Full-text available
Background One possible approach towards avoiding alert overload and alert fatigue in Computerized Physician Order Entry (CPOE) systems is to tailor their drug safety alerts to the context of the clinical situation. Our objective was to identify the perceptions of physicians on the usefulness of clinical context information for prioritizing and presenting drug safety alerts. Methods We performed a questionnaire survey, inquiring CPOE-using physicians from four hospitals in four European countries to estimate the usefulness of 20 possible context factors. Results The 223 participants identified the ‘severity of the effect’ and the ‘clinical status of the patient’ as the most useful context factors. Further important factors are the ‘complexity of the case’ and the ‘risk factors of the patient’. Conclusions Our findings confirm the results of a prior, comparable survey inquiring CPOE researchers. Further research should focus on implementing these context factors in CPOE systems and on subsequently evaluating their impact.
Thesis
Health Information Technology (HIT) is increasingly implemented to improve healthcare quality and patient safety. However, some usability issues may reduce their impact and even induce new problems (including patient safety issues). To avoid those negative outcomes, amongst other actions, HIT usability must be improved. This action requires applying validated usability knowledge. However, usability knowledge applied to HIT is scattered across several sources, is not structured and is hardly usable. Moreover, its coverage regarding related usability flaws is not known. This work has two aims: (i) to participate in improving the accumulation of usability knowledge for HIT and (ii) to provide synthetic structured easy-to-use HIT usability knowledge with a clear coverage. Those aims are applied to medication alerting systems.Method.Two independent analyses of the literature have been performed. On the one hand, usability flaws and their consequences for the clinicians and the work system have been searched and organized; on the other hand, existing usability design principles specific to medication alerting systems have been synthesized. Results of both analyses have been matched together. Results.A systematic review identified 13 types of usability flaws in medication alerting systems. Consequences on the clinicians and the work system are varied: they greatly impede the clinicians and negatively impact the work system (e.g., alert fatigue, alert misinterpretation). Sixty-three usability design principles dedicated to medication alerting systems are identified. They represent six themes: improve the signal-to-noise ratio, fit clinicians’ workflow, support collaborative work, display relevant information, make the system transparent and provide useful tools. The matching between usability flaws and principles is quite good.Discussion.As a result of this work, a list of usability design principles illustrated by actual instances of their violation has been developed. It may help designers and Human Factors experts understand and apply usability design principles when designing and evaluating medication alerting systems. Usability applied to HIT is a recent research field that suffers from a deficit of structured knowledge. This work shows that it is possible to accumulate and structure usability knowledge. It could be carried on by developing a usability knowledge base dedicated to HIT in order to strive towards “evidence-based usability”.
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Health research generates an always growing body of scientific publications. However this scientific production is not systematically integrated into public health. Both researchers and policy makers have constraints that do not naturally facilitate exchanges and knowledge translation (KT) from research into health policy. This thesis focuses on the gap between research and health policy, and the determinants of KT in Cambodia. It includes a literature review on KT issues and on modeling tools, a case study that analyzes the barriers and facilitating factors encountered during a KT intervention, a study of the health research production in Cambodia, a study of the uptake of research findings during health policy making in Cambodia and the integrative analysis of KT determinants identified through various research projects in Cambodia.
Thesis
Full-text available
Health research generates an always growing body of scientific publications. However this scientific production is not systematically integrated into public health. Both researchers and policy makers have constraints that do not naturally facilitate exchanges and knowledge translation (KT) from research into health policy. This thesis focuses on the gap between research and health policy, and the determinants of KT in Cambodia. It includes a literature review on KT issues and on modeling tools, a case study that analyzes the barriers and facilitating factors encountered during a KT intervention, a study of the health research production in Cambodia, a study of the uptake of research findings during health policy making in Cambodia and the integrative analysis of KT determinants identified through various research projects in Cambodia.
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This article presents the results of an experiment designed to validate a set of ergonomic criteria for the evaluation of human‐computer interfaces. Criteria definitions that were designed in a previous study, were tested in a concept‐identification task. Twenty‐four subjects (12 human factors specialists and 12 nonspecialists) were asked to identify the criterion, within a set of 18 elementary criteria, that was violated for each of 36 usability problems. The results show no difference between groups either in terms of performance times or correct identifications. The mean percentage of correct identifications was 59.85%. This result calls for the refinement of some definitions. A detailed examination of the data and an analysis of confusion matrices permits the identification of categories of well‐defined criteria and categories of criteria that would benefit from improvements in their definitions. These results seem to support the feasibility of an evaluation method based on explicitely defined criteria.
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Several studies stressed that the introduction of CPOE applications deteriorates the doctor-nurse communication. But there are many factors that might influence communication behaviors, as for example the way these communications are organized. The present study aims at showing that the impact of a CPOE system on the cooperative activities can be controlled given that a good understanding of the cooperative workflows support the implementation. By analyzing the doctors-nurses communications during the medication use process, the study demonstrates that the technical system has no impact on the cooperative activities within a given organization. CPOE does not induce differences in the dialogs' durations and contents.
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While healthcare information technology (HIT) offers extraordinary promise of clinical improvement and greater efficiencies, the realization of the promise must confront and overcome a number of challenges caused by incomplete and inappropriate software design. In this paper, we review several types of HIT design and workflow decisions that limit the value and utility of HIT in electronic health (medical) record (EHR/EMR), computerized physician order entry (CPOE), and electronic medication administration record (eMAR) systems. While remedies for problems of design or workflow may be either easy or difficult, , the industry creates additional barriers in the contractual relationships it creates between itself (HIT vendors) and the clinical facilities (hospitals, clinics, and physician offices) that purchase its systems. We suggest that the structure of those relationships may retard the progress and responsiveness of HIT.
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To examine the impact of design aspects of computerized physician order entry (CPOE) systems for medication ordering on usability, physicians' workflow and on medication orders. We systematically searched PubMed, EMBASE and Ovid MEDLINE for articles published from 1986 to 2007. We also evaluated reference lists of reviews and relevant articles captured by our search strategy, and the web-based inventory of evaluation studies in medical informatics 1982-2005. Data about design aspects were extracted from the relevant articles. Identified design aspects were categorized in groups derived from principles for computer screen and dialogue design and user guidance from the International Standard Organization, and if CPOE-specific, from the collected data. A total of 19 papers met our inclusion criteria. Sixteen studies used qualitative evaluation methods and the rest both qualitative and quantitative. In total 42 CPOE design aspects were identified and categorized in seven groups: 1) documentation and data entry components, 2) alerting, 3) visual clues and icons, 4) drop-down lists and menus, 5) safeguards, 6) screen displays, and 7) auxiliary functions. Beside the range of functionalities provided by a CPOE system, their subtle design is important to increase physicians' adoption and to reduce medication errors. This requires continuous evaluations to investigate whether interfaces of CPOE systems follow normal flow of actions in the ordering process and if they are cognitively easy to understand and use for physicians. This paper provides general recommendations for CPOE (re)design based on the characteristics of CPOE design aspects found.
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The integration of Human Factors is still insufficient in the design and implementation phases of complex interactive systems such as Computerized Physician Order Entry (CPOE) systems. One of the problems is that human factors specialists have difficulties to communicate their data and to have them properly understood by the computer scientists in the design and implementation phases. This paper presents a solution to this problem based on the creation of common documentation supports using Software Engineering (SE) and Human-Computer Interaction (HCI) methods. The integration of SE and HCI methods and models is an interesting means for modelling an organization's activities, with software applications being part of these activities. Integrating these SE and HCI methods and models allows case studies to be seen from the technical, organizational and ergonomic perspectives, and also makes it easier to compare current and future work situations. The exploitation of these techniques allows the creation of common work supports that can be easily understandable by computer scientists and relevant for re-engineering or design. In this paper, the basic principles behind such communication supports are described and illustrated by a real case study.
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The objective of this paper is to define a comprehensible overview of the Human Factors approach to biomedical informatics applications for healthcare. The overview starts with a presentation of the necessity of a proper management of Human factors for Healthcare IT projects to avoid unusable products and unsafe work situations. The first section is dedicated to definitions of the Human Factors Engineering (HFE) main concepts. The second section describes a functional model of an HFE lifecycle adapted for healthcare work situations. The third section provides an overview of existing HF and usability methods for healthcare products and presents a selection of interesting results. The last section discusses the benefits and limitations of the HFE approach. Literature review based on Pubmed and conference proceedings in the field of Medical Informatics coupled with a review of other databases and conference proceedings in the field of Ergonomics focused on papers addressing healthcare work and system design. Usability studies performed on healthcare applications have uncovered unacceptable usability flaws that make the systems error prone, thus endangering the patient safety. Moreover, in many cases, the procurement and the implementation process simply forget about human factors: following only technological considerations, they issue potentially dangerous and always unpleasant work situations. But when properly applied to IT projects, the HFE approach proves efficient when seeking to improve patient safety, users' satisfaction and adoption of the products. We recommend that the HFE methodology should be applied to most informatics and systems development projects, and the usability of the products should be systematically checked before permitting their release and implementation. This requires the development of Centers specialized in Human Factors for Healthcare and Patient safety in each Country/Region.
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This paper presents a preliminary contribution of a Human Factors (HF) approach to prevention of Adverse Drug Events (ADEs), developed within the European research project Patient Safety through Intelligent Procedures in medication (PSIP). Following an introduction on the role and relevance of HF in ADEs prevention, a number of systemic weaknesses encountered during the field activity analysis are presented and discussed. Semi-structured interviews and observations of medication cycle activities led to infer potential unreliability of some decision-making and drug administration procedures. In particular, the usage of current electronic support systems emerged as a crucial related element. These findings represent an initial contribution which will be further developed within PSIP, as HF have been recognised fundamental contributors to ADEs epidemiological knowledge and appropriate prevention.
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Adverse drug events (ADEs) are a public health issue. The objective of this work is to data-mine electronic health records in order to automatically identify ADEs and generate alert rules to prevent those ADEs. The first step of data-mining is to transform native and complex data into a set of binary variables that can be used as causes and effects. The second step is to identify cause-to-effect relationships using statistical methods. After mining 10,500 hospitalizations from Denmark and France, we automatically obtain 250 rules, 75 have been validated till now. The article details the data aggregation and an example of decision tree that allows finding several rules in the field of vitamin K antagonists.
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The objectives of this paper are: In this approach, the implementation of such a complex IT solution is considered a major redesign of the work system. The paper describes the Human Factor (HF) tasks embedded in the project lifecycle: (1) analysis and modelling of the current work system and usability assessment of the medication CPOE solution; (2) HF recommendations for work re-design and usability recommendations for IT system re-engineering both aiming at a safer and more efficient work situation. Standard ethnographic methods were used to support the analysis of the current work system and work situations, coupled with cognitive task analysis methods and documents review. Usability inspection (heuristic evaluation) and both in-lab (simulated tasks) and on-site (real tasks) usability tests were performed for the evaluation of the CPOE candidate. Adapted software engineering models were used in combination with usual textual descriptions, tasks models and mock-ups to support the recommendations for work and product re-design. The analysis of the work situations identified different work organisations and procedures across the hospital's departments. The most important differences concerned the doctor-nurse communications and cooperation modes and the procedures for preparing and administering the medications. The assessment of the medication CPOE functions uncovered a number of usability problems including severe ones leading to impossible to detect or to catch errors. Models of the actual and possible distribution of tasks and roles were used to support decision making in the work design process. The results of the usability assessment were translated into requirements to support the necessary re-engineering of the IT application. The HFE approach to medication CPOE efficiently identifies and distinguishes currently unsafe or uncomfortable work situations that could obviously benefit from an IT solution from other work situations incorporating efficient work procedures that might be impaired by the implementation of the CPOE. In this context, a careful redesign of the work situation and of the entire work system is necessary to actually benefit from the installation of the product in terms of patient safety and human performances. In parallel, a usability assessment of the product to be implemented is mandatory to identify potentially dangerous usability flaws and to fix them before the installation.
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To develop a new method to improve the detection and characterization of adverse drug events (ADEs) in hospital patients. Prospective study of all patients admitted to our hospital over an 18-month period. LDS Hospital, Salt Lake City, Utah, a 520-bed tertiary care center affiliated with the University of Utah School of Medicine, Salt Lake City. We developed a computerized ADE monitor, and computer programs were written using an integrated hospital information system to allow for multiple source detection of potential ADEs occurring in hospital patients. Signals of potential ADEs, both voluntary and automated, included sudden medication stop orders, antidote ordering, and certain abnormal laboratory values. Each day, a list of all potential ADEs from these sources was generated, and a pharmacist reviewed the medical records of all patients with possible ADEs for accuracy and causality. Verified ADEs were characterized as mild, moderate, or severe and as type A (dose-dependent or predictable) or type B (idiosyncratic or allergic) reactions, and causality was further measured using a standardized scoring method. The number and characterization of ADEs detected. Over 18 months, we monitored 36,653 hospitalized patients. There were 731 verified ADEs identified in 648 patients, 701 ADEs were characterized as moderate or severe, and 664 were classified as type A reactions. During this same period, only nine ADEs were identified using traditional detection methods. Physicians, pharmacists, and nurses voluntarily reported 92 of the 731 ADEs detected using this automated system. The other 631 ADEs were detected from automated signals, the most common of which were diphenhydramine hydrochloride and naloxone hydrochloride use, high serum drug levels, leukopenia, and the use of phytonadione and antidiarrheals. The most common symptoms and signs were pruritus, nausea and/or vomiting, rash, and confusion-lethargy. The most common drug classes involved were analgesics, anti-infectives, and cardiovascular agents. We believe that screening for ADEs with a computerized hospital information system offers a potential method for improving the detection and characterization of these events in hospital patients.