1.

DATA COLLECTION

To determine what data elements are required for a clinical care information system, three fundamental questions need to be asked. What data is required to perform various clinical tasks? What useful data would be generated as a result of the tasks? What data need to be recorded?

A well accepted dictum in data management is to capture data once, and use it whenever necessary. Yet, at a glance, much of clinical data appears to be captured repeatedly. n closer e!amination, the repetition arises because values for the same attributes are captured at different occasions or clinical events. The "lectronic #edical $ecord %"#$& is a chronological record of clinical events. The ma'ority of clinical data is dynamic not static because much of it is a record of biological parameters which varies according to circumstances. (alues of various attributes often change with time and need to be documented as and when these changes produce an impact or when the occurrence or non)occurrence of a variation from the initial value %the baseline& has clinical relevance. *athering the same data more than once is that many aspects of clinical data gathering %obtaining history, eliciting clinical signs& are sub'ective and very performer dependent. +ence a more e!perienced clinician may want to retake the history or re)e!amine the patient even if a former member of the care team has taken it. The difference between the two sets of data is in their %perceived or actual& degree of accuracy. ,linical information originates from many data sources which include Available data $esults of Tasks .erformed ,linical data gathering /nterviews %symptoms& and

b'ective assessment %signs& 1indings during intervention #onitoring of clinical parameters b'ective observation b'ective measurement using various measuring tools $esults of investigations, tests $esults of intervention $ecord of "vents ,ommunications

.atients arriving for consultations may bring along information regarding care in their previous health care facility in the form of $eferral letters 2otes 3 .rintouts ,ase summary .atient carried records

These documents can be scanned as images and stored for later reference. To do this, an order is placed to scan the document. "ach image is automatically given a unique identifier and becomes one data item. To retrieve and view the images the user will have to launch an image viewing application. Taking a history and eliciting signs is a task performed by all direct care providers %doctors, nurses, physiotherapists etc&. pharmacists&. Whether information is volunteered by patients or elicited by care providers the data need to be recorded and stored in an ob'ective manner. The medical profession, over the long ther direct care providers and also indirect care) providers can then use this information subsequently %laboratory staff, imaging staff,

period of its history, has developed fairly standard methods of eliciting information and also the terms used for documenting them. /n an effort to standardise, various professional organisations have developed uniform naming conventions and terminology. +owever in any given organisation, it is necessary to gain consensus among care providers as to which of these to adopt. /t would appear that because there are so many symptoms and signs and so much variations in them, it is much easier to allow providers to use their own words in the form of unstructured te!t to describe these. Transcription of dictated voice recording would use such a method. ,apture and storage of te!tual record as a document is another way. +owever this would result in grave disadvantages and also a failure to ma!imi5e the benefits of computerisation. The correct approach would be to provide the care provider with the means of capturing structured data, at least for some pertinent data. (arious symptoms and signs should be considered as attributes of an entity i.e. the patient and each attribute has one or more distinct values chosen from a list of possible values. +ence when documenting a symptom like pain, various descriptions of 6pain7 %location, severity, duration, other characteristics& are provided to the care provider through the use of drop down values, check bo!es etc. .roviding choices of data values from a predetermined list for a particular data field, gives the following advantages .rovide guidance and encourage adherence to a uniform system "liminate typographical errors "nsure uniformity in use of terms

8se of structured data allows for recognition, counting and grouping of the data making them suitable for analysis. 2umerical values can be assigned to each result even for non) quantitative data, providing the means for summation or scoring. 9y comparing with reference information these data be used in :ecision support in determining the probability of a diagnosis using diagnostic criteria ;

*rading of severity, staging, risk stratification and categorisation of illness. utcome documentation %symptoms and signs can be used as indicators&

An alternative would be to transcribe the data provided. This is especially so in the instances where the referral letter is not very structured or need to be interpreted because of illegibility or where the information is obtained verbally from the patient. 2ote that these are historical data and not data generated by the care provider themselves. The data arrangement would be quite similar to a summary-

2.0

DATA ANALYSIS

:ecision making process under uncertainty is largely based on application of statistical data analysis for probabilistic risk assessment of decision. :octors need to understand variation for two key reasons. 1irst, so that they can lead others to apply statistical thinking in day to day activities and secondly, to apply the concept for the purpose of continuous improvement. Awareness about outcome is useful for both the primary user and the secondary user of "lectronic #edical $ecord. 1or the care provider knowing the outcome allows him to make decisions regarding choice of therapy %continue, discontinue or alter&. +e would also be able to inform the patient regarding his 3 her progress and prognosticate more ob'ectively. When used in #edical Audit outcome data allows for comparisons to be made with e!pected outcome as achieved by other practitioners. ,omparing actual outcome with the desired standard is an essential element of quality control. As such the ob'ectives of care need to be stated once the health problem is identified. At the initial point when the diagnosis is couched in general terms then only general ob'ectives can be stated. /f it is confirmed that the patient belongs to a particular

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sub)set of the patient population %specific disease of known variant and severity& then a specific ob'ective based on universally accepted evidence)based benchmark could be set. Therefore, ob'ectives are part of the patient care plan and in fact determine the content and organi5ation of the plan. The assessment of outcome is part of the activity of progress review and recording is done in the progress notes. This is true for intermediate outcome i.e. results of various interventions performed. 1or the final outcome, in traditional practice, is derived retrospectively rather than e!plicitly stated at the time care is given. A change in approach needs to be advocated. The recording of outcome or otherwise the parameters from which outcome can be computed indirectly, should be mandated at certain points in the care of the patient. Appropriate occasions may be /mmediately after an intervention %immediate effect of therapy&, At predetermined intervals in progress review depending on nature of illness %may intervals of minutes, hours or days& At the end of an outpatient encounter %especially follow up visit& n discharge for an in)patient encounter At the end of a care episode Ad hoc as and when events that reflect on outcome %indicators& occur

The e!pected outcome of care can be a measure of +ow far the patient=s e!pectations have been met >uccess in achieving the optimum results compared to what is achievable for the type and comple!ity of the disease 3 health problem. The characteristics to be measured may be somatic, psychological, economic or social. Those related to overcoming the illness$elief of symptoms ,ure or amelioration

$eduction of morbidity of illness >urvival 3 #ortality Arrest of progression of disease $estoration of function $esumption of physiological functions $esumption 3 attainment of activity daily living $esumption 3 attainment of work, schooling and recreational activities .sychological and social well)being Another set of characteristics relates to the quality of the service provided and includeTimeliness %absence of delay& :uration %length of stay, number of visits& ,omplications and side effects of treatment Appropriateness Adequacy ,ost

,omparison of outcome of a patient with what can be achieved for similar patients. ,omparison of performance in managing a particular patient group with universally accepted standards 1or purposes of comparison, patients must be assigned to a case category or patient group having the same characteristics. The characteristics include :iagnosis %disease, disease group& (ariant or grade of disease or health problem >tage or >everity level ,o)morbid factors

Therefore for purposes of assigning patients to appropriate case category, the relevant data from diagnosis, clinical findings at first visit 3 on admission, laboratory physiological parameters must be identified and made available. The e!pected outcome also termed the standard is usually set by the organisation based on empirical evidence %research, past e!perience&. /n quality management care providers, managers, patient groups and other stakeholders are interested in comparing the performance of one organisation %hospital, clinic, unit& against another. 8sually the indicator used is the average performance of a defined population. To obtain the average the individual performance mentioned above must be available. Also the need to compare between similar case categories %apples with apples& requires definition of criteria for inclusion of patients into the population being compared. /n the past, with paper records, the inability to compute outcome 3 performance measures arises because of missing, incomplete or inaccurate data. With computeri5ation, these problems can be overcome only if the required parameters are thought of in advance and their recording is mandated at certain points in the care of the patient. >ome outcome data need to be e!pressed e!plicitly by the care)provider. #ost can be derived through computation using appropriate formulas. 3.0 CLINICAL DATA REPOSITORY

A clinical data repository is defined as a repository of clinical information normally residing on one or more independent platforms for use by clinicians and other personnel in support of longitudinal patient)centric care. :ata is organi5ed in a format that supports the clinical decision)making process requisite to patient care, independent of the physical location of that patient information. The ability to create a composite, portable, legal medical record will enable providers to obtain integrated data views %computable views& and acquire the patient)specific clinical

information needed to support treatment decisions. An integrated clinical data repository used to enhance the data aggregation and reporting needs. 8sing a database as the foundation for information systems has distinct advantages that include /mproved integration, sharing and continuity of information Avoidance of repetition and duplication of data acquisition 3 entry "asier and rapid access and retrievable of data 9etter control of data resulting in improved data quality /mproved security

A database makes it possible for any data generated as the result of an activity to be captured, stored and used whenever and wherever it is required. :ata already available need not be collected again unless changes warrant it. This obviates the need for repetition and duplication of data collection and allows for sharing of data within the organisation and with other organisations. 8se of the database as a data depository allows for e!traction of pertinent data %counting of incidences of a particular event, categorisation, defining populations by categories and sampling&. :ata is managed through a formalised structure making control over it easier and more effective. +owever all these are only possible if the database is well organised and designed. :esign of databases incorporates conceptual, logical and physical design. /n this paper only the conceptual design of the database would be discussed.

4.0

REPORTING

:iagnosis is an essential data element used e!tensively by primary as well as secondary users for a wide variety of purposesB from clinical decision making to costing. 1or this reason there is a great need for standardi5ation of terminology and nomenclature regarding diagnosis. :iagnosis can be defined as the conclusion regarding a person=s

health derived from the interpretation of various clinical data e!pressed as any of the following A disease entity and the relevant accompanying features of that disease entity :eviation from normal status ,onfirmation of normal status The accompanying features of the disease are characteristics such asnset and duration of illness Anatomical site involved %for diseases which may affect different sites& Aetiology %cause& >ub)categories based on age, aetiological agents or other factors >everity of illness ,omplication of illness ,o)morbid factors

The incidence and prevalence of diseases of various aetiological groups or categories are of interest to epidemiologists. /n quality management, the diagnosis, to a great e!tent, identifies the service product to be delivered. .atients with the same diagnosis are e!pected to follow the same care plan %with allowable variations&. The outcome is also e!pected to be within the same range of outcome standards. The frequency of occurrence of health problems of different body systems and sites and their comple!ity %diagnostic related groups and case mi!& reflect on the workload and e!pected e!penditure of health care)providers who managed them. This can be used as a guide to resource allocation and health system planning. ,urrently, there are two approaches to documenting diagnosis :ocumenting diagnosis as a list of problems :ocumenting :iagnosis as .re)categorised /tems

This is the traditional approach. /t is a useful way of addressing a diagnosis for a care visit or episode. 1aced with the problems of the patient, the clinician asks the following questionsD

What is the patient=s main problem? What other illness befall the patient at the same time? What is the patient=s pre)morbid status? ,an the patient=s condition be e!plained on all problems identified? 1or which of these problems is the diagnosis certain and therefore treatment can be initiated?

This method of documenting 3 viewing diagnosis is based on the problem)based approach. +ere all diseases or illnesses affecting the patient are considered as health problem to be solved. This approach looks at health problems in a holistic manner from a case manager=s perspective. +ence the diagnosis is listed in a sequential manner. The questions being asked are What are all the problems affecting the patient? What are the characteristics of each problem? What is the status of resolution of these problems?

/t is customary to think of a summary as a note written at the end of a clinical care episode. A computeri5ed clinical information system provides the means for generating a summary based on information available in the database at any point of time. ,onscientious clinicians always review and put together information regarding the patient at regular intervals in order to clarify the status of the patient and his 3 her illness. A clinical summary can be a dynamic set of information rather than a once only composition. +ence for every patient a view %a query of the database& containing salient data regarding the patient should be available constantly to the care provider. 2evertheless, there are several occasions where a case summary needs to be created as a report. The summary can be appended to various documents used in the communicational processes of clinical care. +ence the case summary can be appended to rder details in request forms

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:ischarge note $eferral letter %,onsultation request& $eply letter >econdary users also require case summaries for various purposes includingAs part of #edical $eport %#edico)legal reports, /nsurance claims&

1or qualitative analysis of care %,ase audit, "nquiries&

The content of a summary depends on the purpose for which it is intended. 9ecause summaries are a subset of the clinical data and a query of the database only available data can be included in it. 1or purposes of communications between clinicians much of the data need to be clinical. 1or other purposes %#edico)legal reports, /nsurance claims& only critical events and their chronology %sequence, actual dates and times of occurrence& may be important. /t must be remembered that data regarding a patient is confidential information and should be divulged only to privileged individuals or with consent.

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