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Computerized medical records (CMR) are used in most Australian general practices. Although CMRs have the capacity to amalgamate and provide data to the clinician about their standard of care, there is little research on the way in which they may be used to support clinical governance: the process of ensuring quality and accountability that incorporates the obligation that patients are treated according to best evidence.
The objective of this study was to explore the capability, capacity, and acceptability of CMRs to support clinical governance.
We conducted a realist review of the role of seven CMR systems in implementing clinical governance, developing a four-level maturity model for the CMR. We took Australian primary care as the context, CMR to be the mechanism, and looked at outcomes for individual patients, localities, and for the population in terms of known evidence-based surrogates or true outcome measures.
The lack of standardization of CMRs makes national and international benchmarking challenging. The use of the CMR was largely at level two of our maturity model, indicating a relatively simple system in which most of the process takes place outside of the CMR, and which has little capacity to support benchmarking, practice comparisons, and population-level activities. Although national standards for coding and projects for record access are proposed, they are not operationalized.
The current CMR systems can support clinical governance activities; however, unless the standardization and data quality issues are addressed, it will not be possible for current systems to work at higher levels.
Clinical governance is an approach to ensuring quality and accountability that incorporates the obligation that patients are treated according to best evidence (
Computerized medical records (CMR-see
It is important to understand the context within which records are created [
We carried out this investigation to see, firstly, how the nature of the design of different vendors’ CMR systems enable and constrain clinical governance and, secondly, how individuals and groups might use computers differently as tools to measure quality and to achieve clinical governance objectives. We describe an assessment tool that would enable others to assess the extent to which any CMR could act as a mechanism within their health care context to support clinical governance.
Clinical governance is a term first used within the UK National Health Service (NHS) to describe a process for maintenance, improvement, monitoring, and accountability for clinical standards.
The NHS clinical governance process made chief executives responsible and accountable for clinical quality in their organization alongside business goals and budgetary control.
Clinical governance also challenged the “clinical freedom” of doctors. Up to its inception, a doctor only needed to justify their actions in terms of them judged to be reasonable by a group of peers. The onus changed to one where clinicians are expected to deliver best practice, usually as defined in evidence-based guidelines, and to participate in clinical audits of their standards of care.
Persistent deviation from guidelines, or being an outlier in audit might be the cause for review.
Classification system
A range of terms exists to describe CMR systems. The classifications reflect differences in the following areas:
Purpose: Intended to be a life-long or partial record of a patient’s health or medical treatment.
Disciplinary base: Based on the “medical model” or a broader “health” record.
Proprietorship: Owned and controlled by the patient or their proxy, or by the health care provider or health care system.
Definitions:
Our preferred term:
This study was a component of a larger systematic review and realist synthesis of clinical governance in primary care [
Computerized information systems can use routine data, and specially captured additional data (eg, patient questionnaires) to audit quality.
Clinical governance makes demands of managers, clinicians, and information systems:
Managers: Responsible and accountable for clinical standards within their organization; including mechanism for measuring them.
Doctors: Clinicians are now expected to deliver best practice as defined in evidence-based guidelines; and participate in clinical audit.
Information systems: It should play a role beyond individual patient care, practice, and locality audits. The CMR should enable practices to benchmark quality, and governments to see there is return on investment by ensuring it supports evidence-based practice.
Patients’ views of the service and their “experience” of healthcare are an important measure of quality, which is missing in current systems.
We carried out a review from a realist perspective, mirroring the approach of the main study [
In realist evaluations, there can sometimes be difficulty in distinguishing context and mechanism. In this analysis, the context (C) is the Australian primary health care context, and the mechanism (M) is the CMR system used at the point of care. Our outcome measure (O) was the ability to produce clinical governance outputs through the ability to monitor quality of care against given criteria and standards. This combination describes how in the Australian context (C), the CMR, might contribute as a mechanism (M) to deliver the outcome measure (O), clinical governance (C+M=O) (
We mapped the primary care context using Lusignan’s 4 component classification [
Organization: We considered the ways in which primary health care was organized at the practice, locality, and at the national level in Australia.
Individual clinicians: We considered the level of knowledge, skill in operation, and attitude toward CMR among individual general practitioners.
Clinical task: We considered the clinical context during which the CMR would be used. This was usually a one-to-one clinical consultation, in which the presence of the desk-based CMR created a triadic clinical relationship [
Technology: We considered the features of the technology, which are unique to the particular context. Australia is in the process of enhancing broadband access, but this is unequally distributed around the country.
The contextual features discovered through this review were then analyzed in concert with the mechanisms of the CMR described below to develop a nuanced understanding of how the CMR operated in this particular environment to produce governance outcomes.
To identify the ways in which the CMR operated in relation to clinical governance, we used the Donabedian [
“Structures” included the physical structures and design features (including conventions for room layout, record architecture, and linkages).
“Processes of care and review” included software capabilities such as the issuing of prescriptions.
“Processes that may impact upon on patient outcomes” included elements such as the ability of the CMR system to detect and block all serious drug interactions.
Each of these categories was subcategorized to produce the detailed tool across the categories (
We explored factors related to clinical governance outcomes occurring at the level of the patient, the health care provider, and the setting (ie, impact at the population- or health system-level) [
We created a new assessment tool (
The top six CMR systems measured in terms of user base [
We developed a CMR maturity model, again using the Donabedian classification into structures (including IT architecture issues), process and outcomes, using existing consensus about CMR maturity [
The process and potential of the CMR to influence clinical governance outcomes were graded into a four-level model (
Donabedian based assessment of CMR as a mechanism to support clinical governance.
Structures | Element explored | |
System Architecture |
Interface, clinical archetypes, database type, coding systems | |
Information & Decision Support | Drug databases, interactions, clinical calculators | |
System Linkages | Patient registrations, laboratory links, Email | |
Search Function | Across populations, practices, Export functions | |
Patient access/Control | Access to information through web portals, etc. |
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Quality Markers | Data quality, information quality, system accreditation |
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Billing/Pay for Performance | Routine data use, parallel billing system |
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Supports population level data outputs | Small area, sentinel networks, epidemiology |
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Processes that impact on outcomes (demonstrated within the system) | Critical incidents / near misses / confidential reporting; surrogate markers of quality and outcomes/Clinical audit; true outcome measures |
Medical Director 2 (Health Communication Network, Sydney, NSW)
Best Practice (Best Practice Software, Bundaberg, Queensland)
Genie (Genie solutions, Brisbane, Queensland)
Medtech32 (Medtech Global, Melbourne, Victoria)
Plexus (iSoft, Sydney, NSW)
Profile (Intrahealth Systems, Sydney, NSW)
Promed (Promedicus Systems, Melbourne, Victoria)
CMR and CG maturity model: moving through passive, interactive, and autonomous modes.
Level 1 | Level 2 | Level 3 | Level 4 | |
Simple |
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Complex | Adaptive systems | |
External adverse event reporting (no use of system) | Reporting involving information from CMR | Reporting using the CMR as vehicle | Interactive reporting where CMR sends and receives information, informing user of the risks | |
Simple prescribing | Prescribing with limited functions (interaction checking) | “Intelligent” prescribing where CMR uses local information such as guidelines to inform prescribing decisions | “Autonomous” prescribing where system integrates internal and external information to determine optimal management | |
Simple audit feedback loops | Audit data compared with external data to assess performance | Audit data pooled and used to develop local benchmarks as well as population health activities | Real-time data aggregation and assessment to allow ‘just in time’ monitoring of population, during pandemics, for example | |
Largely External to CMR | Integrated in CMR | CMR linked to other information sources | Integrated into health system | |
Distributed database |
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Overview model of the method to appraise whether in the context of Australian primary care the CMR provided a mechanism for driving clinical governance.
Schema of the maturity framework.
In Australia primary care is delivered via general practice through around 7000 discrete practices. Practices in Australia have a variety of ownership structures including corporate owners, partners, associates, and sessional general practitioners (GPs). Some CMRs enabled varying degrees of control according to status within the practice-owner, employee, etc. Patients are free to visit any GP of their choice, and GPs act as gatekeepers to secondary care. Mobility of patients between practices means that they lack the stable population denominator of registration based systems such as those found in the UK or Netherlands. Funding is largely fee-for-service underpinned by a national insurance scheme, but there are many accessory payments [
The GPs in Australia are trained in the Australian General Practice Training Program. The curriculum for training [
Although doctors use many sources of information in the consultation [
We identified four technological issues that compromise clinical governance activities:
Different (and local) coding systems make national and international comparison of quality more challenging.
The absence of standards meant CMR vendors can choose to develop and implement their own messaging ‘standard’ for use between variants of their program including use of varying flavors of Health level-7 (HL7), with much less scope for quality control and minimizing the risk of inbuilt errors.
Patient access to the record was absent. Such facilities are not part of the Australian landscape yet.
Backup facilities were not inbuilt functions of the software, but were integrated into general system backups according to accepted guidelines.
The individual clinician had little influence on the software processes. In comparison with paper records, we felt the CMR disempowered the clinicians–in effect ceding many areas of control to the organization or the technology. Customization options were minimal. Some programs did not allow individual doctors to change their passwords without going through an administrator. Access controls for all staff were either set by the program or customisable by a designated administrator.
A significant amount of data required to perform key clinical tasks is now provided by third parties, who have to be trusted themselves to have proper governance systems. The responsibility, governance, and overall control of these information sources sit outside of the CMR. For example, drug information was derived from either government sources or from the industry. Until 2009, the most popular general practice software incorporated screen drug advertising. An audit of these advertisements found that 95% were non-compliant with the Medicines Australia Code of Conduct, though there was a little evidence that this impacted upon prescribing practice [
There are significant gaps and variability between Australian CMR systems in their drug interaction checking [
Some areas were easy to ascribe to an actor, but others were quite complex. Drug Interactions, for instance, required taking an externally provided database, integrating it into the program, and then allowing GPs to potentially customize the level of alert setting, and then integrate all of that into the consultation. Others such as practice audit required a reliable software process that was then dependent on a practice system to make best use of the information.
Contextual elements that support and limit clinical governance using computerized medical records.
Context | Reviewed Elements |
Organizational | Accessible by different cadres of practice staffa |
Accreditation standards includes clinical governancea | |
Patients are not enrolled, and can be very mobileb | |
Individual clinician | Clinicians receive training in operating computersa |
Nearly half of Australian GPs are involved in quality auditsa | |
Clinical task | Individual clinicians have little autonomy over the software system, and must respond to its settingsb |
Technology | Variety in coding systemsb |
Lack of standardizationb | |
No patient accessb | |
No back-up systems for CMR itselfb |
aContextual elements that support clinical governance using computerized medical records.
bContextual elements that limit clinical governance using computerized medical records.
All systems generated a unique identifier for each patient, and all recorded the Medicare number (a non-unique number used for the federal insurance scheme). All CMR systems utilized a graphical user interface and all had standard clinical archetypes such as history, examination, past history, and social history. All were able to provide a summary view although differences in those views were apparent [
None used the Systematised Nomenclature of Medicine–Clinical Terms, the official Australian standard and none required data to be entered in a coded fashion, and two of the coding systems are specific to that brand of software. All the CMR systems allowed attribution of data according to login or according to source. Some incoming data (such as specialist letters) required manual attribution, while for data such as pathology, the attribution was automatic.
Every CMR system was able to accept pathology and radiology as atomized data (either HL7 or Pathology Interchange Format). All programs allowed linking of requests with received reports. Four packages allowed both generation of electronic documents and receipt. All used proprietary systems to do this, with little ability to work cross platform.
The CMR systems (in keeping with the genesis of software systems as electronic prescribing packages) had comprehensive drug databases. Most used the database from MIMS Australia, otherwise using information from a variety of sources. Data regarding Australia’s Pharmaceutical Benefits Scheme (PBS), which detailed government subsidies for most drugs, was sourced from the PBS itself. All had the ability to generate drug interactions, although users were able to set the level of drug interaction alerts and in several systems turn them off altogether. Use and availability of drug calculators (weight/dose calculators or warfarin calculators) was extremely variable. All packages had a variety of other external information sources available from within the system.
All CMR systems had immunization information; many had travel information, and one had an extensive library of text based health information resources within the program.
All programs have search functions built into the system. Most have some inbuilt searches (patients over 65 years, eligible patients without a cervical smear in the last five years) that relate to funding initiatives or chronic disease management. The ability to do other searches was quite variable and often required significant computer/database knowledge
Only four of the CMR systems were able to participate in regional data quality activities. These activities revolve around the Australian Primary Care Collaborative program, The Practice Health Atlas and the PEN Clinical Audit tool [
No system had inbuilt data quality checks (prescribing insulin without a diagnosis of diabetes for example). One system had its own ‘in-house’ sentinel/research network ability; no other program had such a designated function.
Mechanisms that support and limit clinical governance from computerized medical records.
Mechanism | Reviewed Elements |
Structures | External resources (eg, MIMS) includeda |
Alert to drug interactionsa | |
Accept pathology and radiology results as atomised dataa | |
Limited search facilitiesb | |
Variable drug dose calculatorsb | |
No standardized coding systemb | |
Processes of care and review | Can generate pay for performancea |
Half allow data extraction to participate in auditsb | |
Processes related to outcomes | No inbuilt data checks for qualityb |
Only one allows in-house sentinel data search facilityb |
aMechanisms that support clinical governance using computerized medical records.
bMechanisms that limit clinical governance using computerized medical records.
When context (
Most medical records are computerized and widely used for clinical governance activities, but these approaches are fragmented [
None of the CMRs was able to deal directly with these issues. However, the ability of the systems to provide data to inform activities at this level is increasingly crucial for health system management if we want to be able to explore what population interventions might have impact. Medicare locals, the regional support bodies for primary care services, are able to use the data for informing practice at a local level [
At the structural level, Australian CMRs are well developed but there is scope for further progress against our maturity framework. Lacking are open standards, as yet no implementation of a standard coding system, and probably too many vendors in a relatively small market.
Australian primary care is therefore largely at level 2, with some systems only supporting level 1 and with some systems offering level 3 models. There was no evidence of level 4 systems. Some CMR systems had features that from the international perspective must be a developmental blind alley. The local coding systems are one of these; it is unlikely to ever become part of an interoperable health system.
In the Australian context, at practice and locality level the CMR works well, and is being used to facilitate clinical governance activities. Nearly all practices have systems with search functionality that enable participation in clinical audit.
However, while practices and localities are widely engaged in clinical governance processes, these are usually being done in an uncritical way. In particular, there is little attention given to data quality, or the obligation to code clinical conditions in standardized extractable fashion.
The record structures are often proprietary and there is a dearth of open architectural models, with many mission critical functions happening within a black box.
Benchmarking standards at a national or international level will be challenging if poor data quality and the disparate nature of record systems and system architecture remain unaddressed. Although not a registration based system, denominators such as those who attended in the last year can be used to make comparisons between practices and systems.
It is not possible to have lossless conversion of data held in one coding system to another, and the use of idiosyncratic coding systems increases the risk of data loss. While statistical techniques, in particular multiple imputation [
Disease registers are much more challenging to set up when there is incomplete coded data, and patients with a condition not on a disease register are not going to benefit from computerized prompts or recall. Their standard of care may also be lower. This data quality and use issue will become a major problem as more information is shared.
The complexity of the clinician-patient-computer interaction, touched on in the introduction, is reflected elsewhere in the literature. Patient-centered care [
There is no requirement for CMR systems to provide any specific functionality whatsoever, no set of criteria over information use, and no standards over usability or even formally recommended testing protocols [
Patient access to their records has become the norm elsewhere [
A comparison with the UK system of CMR driven pay-for-performance suggests that there may be quality gaps that computer mediated incentives might help close [
The evaluation took place at a point in time in 2009, and each package has gone through several upgrades over that time. As such, this analysis is not meant as a detailed critique of the packages with recommendations. It is quite possible that many of the comments here may no longer apply to a specific package. Moreover, it is the first discussion of the increasing influences on clinical governance by CMRs, with a framework that can be applied serially or in different contexts. What is lacking in planning and development is a consistent approach to thinking about CMRs and clinical governance, and what systemic controls should be there.
We might have explored the extent to which the standardization of record formats might have aided comparison and measurement of quality. The Royal College of Physicians, UK, has been very active in trying to standardize records reporting handovers, including admission and discharge [
There are also other models we might have used for example: Yousuf et al have proposed an adoption model that includes: user attitude and skills base together with good leadership, IT-friendly environment, and good communication [
These models share some similarity in that they both identify socio-technical aspects of implementation. Had we used either of these models, our subheadings might have been different but our findings are unlikely to have changed. Our selection driven by the wish to emphasize the interaction between organization (which included governance), the individual clinician, the clinical task (which should be of quality) and the technology; and not predefined success factors or progressive levels that should be reached.
The observations in this study have not been tested in a controlled trial and are retrospective in nature. Although we have approached this study from a neutral position of identifying factors that helped and hindered there may be bias. One author (CMP) is very familiar with many of the brands of Australian CMR and may have been susceptible to
We have developed a framework for evaluating how CMR systems support clinical governance in a particular context; and whether the CMR has helped to achieve those goals. By applying the tool to several different brands of Australian CMRs, we have highlighted the issues that exist today, but importantly shown a graded way forward using a simple model and maturity framework that we hope can be readily followed by clinician users of these systems.
The limitations of the process relate to the heterogeneity of the data and their sources, the continuing change over time, but above preeminent is the lack of implementation of standards. While CMR implementation in Australia has enabled better clinical governance improving systems technical capability and rigorous standardization is needed to enable more comprehensive assessment of quality and outcomes for patients.
Software assessment schema.
computerized medical records
electronic health record
general practitioners
Health level-7
International Classification of Disease version 10
National Health Service
Pharmaceutical Benefits Scheme
Our research was funded by a grant from the Australian Government Department of Health and Ageing through the Australian Primary Health Care Research Institute (APHCRI). The opinions expressed in this article are not the opinions of APHCRI or the Department of Health and Ageing.
None declared.