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602 MJA • Volume 193 Number 10 • 15 November 2010
REVIEW
The Medical Journal of Australia ISSN:
0025-729X 15 November 2010 193 10
602-607
©The Medical Journal of Australia 2010
www.mja.com.au
Review
mproving the quality of primary health
care is a complex undertaking. Over the
past decade, clinical governance has
been promoted as a systematic, integrated
approach to assuring safe, good quality
health care.1
Its intent is to move beyond
the organisational “magic bullet” of single
strategies (eg, professional education,
audit, or risk management) to a systematic,
multifaceted approach to quality improve-
ment using a range of locally implemented
strategies.
In Australia, most work on clinical gov-
ernance has been in hospitals2
In the past 5
years, however, there has been an emerging
interest in clinical governance in primary
health care. Failures in health care delivery
occur frequently in primary health care, just
as they do in hospitals. In a study using
anonymous reporting of adverse outcomes
in Australian general practice, errors were
estimated to occur in one in 1000 consulta-
tions;3
of 433 errors, nearly 70% were
attributed to failures in the processes of
health care, and 30% to the failure of indi-
vidual general practitioners’ knowledge and
skills.4
Partly in response to this, the Royal
Australian College of General Practitioners
(RACGP) recently introduced clinical gov-
ernance into its accreditation standards.5
The Victorian Healthcare Association has
developed a range of resources and guide-
lines for clinical governance in community
health.6
Improving quality, safety, account-
ability and performance is one of the four
priorities in the draft national primary care
strategy.7
The final report of the National
Health and Hospitals Reform Commission
(NHHRC) advocated strategies and infra-
structure for quality improvement, and
these are integral elements of the NHHRC’s
recommendations on continuous learning,
monitoring and interprofessional and inter-
sectoral collaboration.8
Given the policy development in this area,
there is a need to clarify models of clinical
governance and the evidence relating them to
quality improvement. Here, we review the
literature on different models of clinical gov-
ernance, exploring their relevance to the Aus-
tralian primary care sector, and their potential
impacts on quality and safety.
METHODS
The key question we examined was: What
models of clinical governance deliver quality
of care? We undertook a systematic review
and realist synthesis of the literature.9
Realist
synthesis is particularly relevant for complex
social interventions, as it aims to develop
explanatory analyses of why and how these
interventions may work in particular settings
and contexts. It is therefore relevant for
policymakers who are keen to explore
whether or not a model may work in a given
context.10
Realist synthesis involves develop-
ing theories and models of how mechanisms
work, using careful analysis of the literature
and interviews with stakeholders.
We developed an operational definition of
clinical governance by reviewing health pol-
icy on clinical governance in Australia, the
United Kingdom and New Zealand (Box 1).
We also reviewed the seminal papers on
clinical governance referenced in those pol-
Can clinical governance deliver quality improvement in
Australian general practice and primary care?
A systematic review of the evidence
Christine B Phillips, Christopher M Pearce, Sally Hall, Joanne Travaglia, Simon de Lusignan, Tom Love and Marjan Kljakovic
ABSTRACT
Objectives: To review the literature on different models of clinical governance and
to explore their relevance to Australian primary health care, and their potential
contributions on quality and safety.
Data sources: 25 electronic databases, scanning reference lists of articles and
consultation with experts in the field. We searched publications in English after 1999,
but a search of the German language literature for a specific model type was also
undertaken. The grey literature was explored through a hand search of the medical
trade press and websites of relevant national and international clearing houses and
professional or industry bodies. 11 software packages commonly used in Australian
general practice were reviewed for any potential contribution to clinical governance.
Study selection: 19 high-quality studies that assessed outcomes were included.
Data extraction: All abstracts were screened by one researcher, and 10% were
screened by a second researcher to crosscheck screening quality. Studies were reviewed
and coded by four reviewers, with all studies being rated using standard critical
appraisal tools such as the Strengthening the Reporting of Observational Studies in
Epidemiology checklist. Two researchers reviewed the Australian general practice
software. Interviews were conducted with 16 informants representing service, regional
primary health care, national and international perspectives.
Data synthesis: Most evidence supports governance models which use targeted, peer-
led feedback on the clinician’s own practice. Strategies most used in clinical governance
models were audit, performance against indicators, and peer-led reflection on evidence
or performance.
Conclusions: The evidence base for clinical governance is fragmented, and focuses
mainly on process rather than outcomes. Few publications address models that enhance
safety, efficiency, sustainability and the economics of primary health care. Locally
relevant clinical indicators, the use of computerised medical record systems, regional
primary health care organisations that have the capacity to support the uptake of
clinical governance at the practice level, and learning from the Aboriginal community-
MJA 2010; 193: 602–607
controlled sector will help integrate clinical governance into primary care.
I
1 Definition of clinical governance
used in this review
• Clinical governance is a systematic and
integrated approach to ensuring services
are accountable for delivering quality
health care.
• Clinical governance is delivered through
a combination of strategies including:
ensuring clinical competence, clinical
audit, patient involvement, education
and training, risk management, use of
information, and staff management. ◆
MJA • Volume 193 Number 10 • 15 November 2010 603
REVIEW
icy documents,11-16
and in the position doc-
uments on systematised quality approaches
in health care in the United States.17
Our
definition of quality used the nine dimen-
sions from the 2001 National Health Per-
formance Framework18
(Box 2).
Eligible studies
Studies were included if they were identified
through the search term “clinical govern-
ance” or used a combination of strategies
outlined in the definition to improve quality
or accountability, and were either conducted
in or applicable to the primary care sector.
Studies were excluded if they focused on
single strategies, or did not aim to improve
quality or accountability. Search terms and
strategy, and data analysis methods can be
viewed in the complete report at http://
www.anu.edu.au/aphcri/Domain/Driv-
ers%20of%20successful%20primary%20he
alth%20care/Access_best_practice_policy_
options.pdf
Information sources
We searched 25 electronic databases, scan-
ning reference lists of articles and consulta-
tion with experts in the field. Our search
was largely limited to publications in Eng-
lish after 1999. A search of the German
language literature for a specific model type
was also undertaken on the recommenda-
tion of a member of our international refer-
ence group. The grey literature was explored
through a hand search of the medical trade
press and websites of relevant national and
international clearing houses and profes-
sional or industry bodies.
Data extraction
All abstracts were screened by one
researcher, and 10% of abstracts were
screened by a second researcher to cross-
check screening quality. Studies were
reviewed and coded by four reviewers using
standardised data extraction sheets and a
data dictionary to record study type and
quality, health service type, elements of
quality in health care and relevance to the
Australian context. Indicators that a study
might be relevant for the Australian context
were: (i) heterogeneous services with differ-
ent systems of funding and governance; (ii)
cultural separation of medical professionals
from bureaucracy; and (iii) loose networks
of primary care services. We included well-
theorised and contextualised case studies
and descriptive studies. All studies were
rated using standard critical appraisal tools
such as the Strengthening the Reporting of
Observational Studies in Epidemiology
(STROBE)19
checklist. Two authors (C M P,
S de L) also undertook a review of Australian
general practice software for its potential
contribution to clinical governance.
Development of models of clinical
governance and their relevance
to Australia
An iterative process was used to develop
models of clinical governance suited to Aus-
tralia, in which the mechanisms underpin-
ning successful models were subjected to
further review. Interviews were held with 16
key informants to review the relevance of
the models and interrogate their feasibility.
Interviewees were selected to illuminate
clinical governance processes at:
• the service level (managers and clinicians
in four key clinical services identified by
their peers as being experienced in clinical
governance);
• the regional level (representatives of
regional health bodies — the Victorian
Healthcare Association, a state-level Aborigi-
nal service, National Aboriginal Community
Controlled Health Organisation, Australian
Primary Care Collaboratives, and Pegasus
Health (a New Zealand not-for-profit organ-
isation that supports 95 practices in the
Christchurch/Canterbury area); and
• the national level (representatives of
accreditation bodies, GP education bodies,
Kaiser Permanente [a US integrated man-
aged care consortium], the UK General Med-
ical Council, and the UK National Primary
Care Research and Development Centre).
Interviews (mean length, 57 minutes)
were transcribed and coded using an emer-
gent coding framework in NVivo, version
8.0 (QSR International, Melbourne, VIC).
This study was approved by the Austral-
ian National University Human Research
Ethics Committee.
RESULTS
Eighty-seven studies were assessed as being
of high quality (Box 3) and, of these, 19
explored the outcomes of clinical govern-
ance. These 19 articles are the focus of this
review. Seven were randomised controlled
studies, 11 were longitudinal observational
studies, and one was a well theorised and
constructed case study. Six studies were
from England,20-25
two from the US,26,27
four from Australia,28-31
two from New Zea-
land,32,33
and one each from Spain,34
the
Philippines,35
Belgium,36
and Germany.37
Only one study compared clinical govern-
ance models in two countries, Holland and
the US.38
Most studies addressed capability.20-23,25-
32,35-37
There were no studies that addressed
continuity or appropriateness of care, and few
that addressed responsiveness20,24,25,27,34,35
and accessibility.20,26,30,33,35
Only four studies
addressed safety.24,25,31,37
Although many stud-
ies explored incentive systems, very few
2 Quality dimensions (adapted from National Health Performance Framework, Australia 2001)18
Quality dimension Description
Efficiency An individual or service can achieve desired results with the most cost-effective use of resources
Effectiveness An individual or service can achieve desired health outcomes
Capability An individual or service has the skills and knowledge to provide a health service
Accessibility A service allows people to obtain health care irrespective of income, geography or cultural background
Safety An individual or service avoids or reduces to acceptable limits the actual or potential harm from health care management
Appropriateness An individual or service provides care, intervention or action that is relevant to the client’s needs and based on established
standards
Continuity An individual or service can provide uninterrupted, coordinated care or service over time
Responsiveness An individual or service provides respect for persons and is client orientated
Sustainability A service can provide infrastructure such as workforce, facilities and equipment to respond to current and emerging needs ◆
604 MJA • Volume 193 Number 10 • 15 November 2010
REVIEW
described a clinical governance process, but
rather posited a kind of black box between the
incentive and the outcome. As a result, only
four studies25,30-32
explored the relationship
between clinical governance and efficiency.
The models that emerged from the litera-
ture and interviews are summarised in Box
4. The strategies most used were audit,
performance against indicators, and peer-led
reflection on evidence or performance.
Assessment of clinical competence was
described relatively infrequently in the stud-
ies as a governance strategy; there are more
articles describing the “enticement” of prac-
titioners into clinical governance than “hard
governance” measures like assessment of
professional competence.39
Box 5 outlines the evidence for each
model’s contribution to the quality domains.
Interventions at different levels can improve
capability of care, but this improvement
appears to be related to the type of care and
how easy it is to systematise care processes.
Improvements in capability are more easily
achieved in prescribing practice than in
chronic disease management, where the evi-
dence for improvement is varied and con-
text-dependent. There are fewer data on
effectiveness (ie, whether the intervention
results in a measurable health improvement)
than on capability (ie, whether the interven-
tion results in an improvement in skills or
practice), but in two uncontrolled studies,
there was an improvement in the outcomes
of chronic disease (angina,20
asthma20
and
diabetes29
) without an improvement in
capability. Both these studies suggest that
trends and/or unmeasured contextual effects
lead to changes in outcomes irrespective of
clinical governance measures.
Most evidence supports governance mod-
els which use targeted, peer-led feedback on
the clinician’s own practice. There is less
evidence supporting interventions across
entire health systems, such as national level
performance indicators, unless this is
accompanied by appropriate levels of sup-
port, including infrastructure support. Top-
down models to drive quality improvement
(external accreditation, or economic incen-
tives for quality measures for doctors)
resulted in no improvements in a range of
4 Description of clinical governance models
Level at which the
model operates Description of model Example Strategies used
National level National benchmarking with or
without regional-level development
support
United Kingdom Quality and
Outcomes Framework
Reporting against national
performance indicators
Regional level Collaboration with other clinicians
or with community, with targeted
feedback on practice
Australian Primary Care Collaboratives;
the National Aboriginal Community Controlled
Health Organisation’s quality use of
medicines program;
New Zealand Pegasus Health’s peer-led networks
Comparing practice or
practitioner outcomes against
one another; peer-to-peer
education exercises
Service level Practice-determined organisation
of quality management, using
targeted feedback to health care
workers with supported reflection
Audit and Best Practice for Chronic Disease
(ABCD) project;
Breakthrough Series methods
Audit; small group reflection
on practice
Multilevel approaches National level benchmarking and
incentive-setting, regional network
support, and support for practice-
level organisation using
targeted feedback
National Prescribing Service Audit; small group reflection;
comparing data on individual
practice with regional averages;
national performance indicators
3 Data searching and inclusion flowchart
Abstracts
retrieved
3670
Complete article reviewed
639
High-quality case studies, observation
and intervention studies
87
High-quality articles of relevance
to Australia
54
Health care process studies
35
Exclude studies not relevant
to Australian context
33
Articles that met inclusion criteria
317
Exclude poor-quality studies
and all commentaries
220
Additional citations identified
through reference list review
96
Additional citations identified
through grey literature review
39
Outcome studies
19
MJA • Volume 193 Number 10 • 15 November 2010 605
REVIEW
quality domains, and in one country with
limited resources (Philippines),35
led to a
decline in accessibility. Sustainability may
also deteriorate under a top-down model of
governance without support and infrastruc-
ture, a risk also noted at interview by work-
ers within the Aboriginal health sector.
Of the 11 software packages most com-
monly used in Australian general practice,
only four enable the user to participate in
regional or aggregated data quality activities.
No system had inbuilt data quality checks
(eg, “How often are angiotensin-modulating
drugs prescribed without renal function
being checked?”). Most have some inbuilt
searches for items that relate to funding
initiatives or chronic disease management.
The ability to do other searches was quite
variable and often required significant com-
puter and database knowledge. Only one
package allowed patient access through a
web portal, to which both the practice and
the patient must have subscribed. Achieving
some degree of standardisation may be an
essential step in the implementation of clini-
cal governance.40
An emerging theme in the interviews
was the lack of clarity around the defini-
tion and purpose of clinical governance.
Concerns were expressed that the concept
might denote governance of or by clini-
cians, rather than strategic approaches to
improving clinical care. There was resist-
ance among professional groups to the
idea of externally set performance indica-
tors, which had the capacity to grow
beyond indicators which would improve
practice. The Aboriginal sector in Aus-
tralia has pioneered the development of
locally relevant performance indicators,
and also reported on the organisational
costs of reporting to multiple discon-
nected performance indicators. Many
interviewees commented on the difficul-
ties of using information systems to best
improve practice in Australia, with a great
deal of energy being expended in extract-
ing data from systems that did not intui-
tively allow this. This was in contrast to
other settings (eg, Kaiser Permanente, and
Pegasus Health’s data on prescribing prac-
tice), where regionalised aggregated data
were available and could be compared
with individual practitioners’ data.
5 Impact of models of clinical governance on quality
Type of model
Evidence for impact on quality
May improve
Conflicting or no evidence
of impact May worsen Authors
National
level
National benchmarking with
regional level development
support
Accessibility; capability Responsiveness Campbell et al 200320
*†
National external benchmarking
with no regional level support
Sustainability;
responsiveness
Gene-Badia et al 200734
Responsiveness; capability Accessibility Catacutan 200635‡
Regional
level
Collaboration with other GPs,
with targeted feedback to
improve practice
Capability; safety Wensing et al 200437§
Effectiveness; capability;
accessibility
Landon et al 200426
*
Collaboration with other GPs
to improve practice, without
targeted feedback
Efficiency Capability; accessibility;
effectiveness
Scott and Coote 200730
Capability Van Driel 200736§
Collaboration with community
to set clinical priorities and/or
monitor services
Accessibility Crampton et al 200533
Service
level
Practice-determined
organisation of quality
management, using targeted
feedback to health care workers
with supported reflection
Effectiveness Capability Bailie et al 200729
*
Effectiveness; capability Valk et al 200438
*
Safety; responsiveness Fraser et al 200224§
Efficiency; safety;
responsiveness; capability
McKinnon 200125§
Capability Effectiveness Cranney et al 199922
*
Capability Cheater et al 200623
*
Capability Effectiveness Si et al 200728
*
Effectiveness;
responsiveness; capability
Ornstein et al27
Effectiveness; capability Baker 200321
*
Multilevel
National level benchmarking and
incentive-setting, regional
network support, and support for
practice-level organisation using
targeted feedback
Efficiency; capability Malcolm et al 200132§
Efficiency; capability Effectiveness; safety Beilby et al 200631§
* Chronic disease management. † Complex care (eg, care of older people, mental health). ‡ Curative services in developing countries. § Prescribing practice. ◆
606 MJA • Volume 193 Number 10 • 15 November 2010
REVIEW
DISCUSSION
The evidence in favour of clinical governance
in general practice and primary care is frag-
mented. The largest body of evidence relates
to the areas that are most easily measured,
such as the quality of prescribing practices.
There is less evidence for quality improve-
ment in chronic disease management and
complex areas like health care for older
people and mental health care. However, the
development of outcome indicators in
chronic and complex care is challenging, and
the lack of evidence of the impact of clinical
governance may reflect measurement diffi-
culties rather than a genuine lack of impact.
More research is needed into interventions to
improve safety, sustainability, efficiency and
responsiveness in primary care.
The most acceptable mechanisms to drive
clinical governance are those that recognise
professional leadership and are perceived as
being locally relevant and allowing reflec-
tion on one’s own professional practice.
There is a reasonable evidence base to sup-
port the role of well resourced peer support
networks to facilitate clinical governance.
Clinical governance strategies that rely on
guidelines alone have not proven effective
among GPs. Performance indicators, clinical
standards and guidelines — advocated in
the Australian Government’s response to the
NHHRC report,41
and in the draft National
Primary Health Care Strategy7
— have a role
in guided reflection and quality improve-
ment. However, exclusive or excessive use of
these top-down mechanisms can result in
opportunity costs for the service,42
disrup-
tion of teamwork if the reporting task is
delegated,43
and constructing clinical activi-
ties around indicators rather than need.44
An increase in the measurement of common
chronic conditions that were the subject of
incentives, over others that were not, was
noted after the introduction of the Quality
and Outcomes Framework in the UK.45
The Australian Government’s response to
the NHHRC report proposed combining
GPs and state-funded community health
systems under the one regional structure,
Primary Health Care Organisations (or
Medicare Locals).41
This would provide a
platform for regional networks to support
clinical governance,46
and would presuma-
bly build on structures such as the Divisions
of General Practice network or Victoria’s
Primary Care Partnerships. The UK experi-
ence suggests that networks of practices
interact to seek corroboration of the value of
new information and evidence within local
networks, before these practices establish
patterns of clinical governance.47
Trust may
be undermined if regional-level involvement
in clinical governance is seen to be only the
collection of data for reporting purposes.
A central difficulty in introducing clinical
governance is a lack of consensus among
primary care workers about its meaning.
Clinical governance remains a poorly under-
stood term, often equated with bureaucratic
control, or medical dominance.48
There is a
need for regional or national organisations to
display leadership in explaining and demon-
strating what clinical governance actually
involves. Examples of leaders in this area are
the RACGP in their standards work and the
work of the Victorian Healthcare Association.
The Aboriginal community-controlled
sector is in the vanguard of clinical govern-
ance in Australia. The development of clini-
cal indicators in some services (eg,
Kimberley Aboriginal Medical Services49
)
preceded mainstream work in this area.
Across the sector, there has been a concerted
and long-term development of capacity and
personnel to drive clinical governance activ-
ities. The opportunity cost of resource-poor
services directing personnel to data collec-
tion for reporting purposes rather than for
data translation to service improvement is
also well understood within the sector.
Input from this sector should be sought
from others in Australia to inform the imple-
mentation of clinical governance across all
primary health care.
The lack of good information on practice
in Australia is a critical constraint for clinical
governance activities. In some organisations
in the US and New Zealand, regional net-
works have access to detailed service-use
data. In Australia, this level of feedback is
only provided through the National Pre-
scribing Service. In all other areas, specific
clinical software is interrogated to generate
routine data on individual practices, but the
software itself is frequently insufficiently
usable by service staff. As a minimum, serv-
ice providers should have access to their
own data on prescribing, tests ordered,
referral patterns, and the demographic pat-
terns and illnesses of their patients. Ready
extraction of these data with a unified cod-
ing system should be built into the stand-
ards developed for clinical software.
For clinical governance to become second
nature in Australian primary care, health
care practitioners need to be actively
engaged as partners in quality improvement.
The evidence is strongest for improvements
that are driven by health professionals at the
practice level, with support from regional
networks. Such activity at regional and serv-
ice levels needs support through structural
changes initiated at the national level. This
should include funding of time for clinical
governance, supported by information sys-
tems which provide ready access for practi-
tioners to their own clinical data.
ACKNOWLEDGEMENTS
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). We are grateful to
members of the national and international refer-
ence groups for their advice, and to Stefanie Webb
and Friedrich Dengel for research support. The
opinions expressed in this article are not the opin-
ions of APHCRI or the Department of Health and
Ageing.
COMPETING INTERESTS
Sally Hall is a member of the Board of APHCRI.
AUTHOR DETAILS
Christine B Phillips, MA, MPH, FRACGP,
Associate Professor1
Christopher M Pearce, MFM, PhD, FRACGP,
Deputy Chair2
Sally Hall, RN, Research Manager1
Joanne Travaglia, BSocWk, PhD, Research
Fellow3
Simon de Lusignan, MB BS, MSc, MD(Res),
Reader4
Tom Love, MPH, MSc, PhD, Senior Research
Fellow5
Marjan Kljakovic, MB BS, PhD, Professor1
1 Academic Unit of General Practice and
Community Health, Medical School,
Australian National University, Canberra, ACT.
2 Melbourne East General Practice Network,
Melbourne, VIC.
3 Centre for Clinical Governance and Health,
Faculty of Medicine, University of New South
Wales, Sydney, NSW.
4 Division of Community Health Sciences,
St George’s — University of London, London,
UK.
5 Department of General Practice, Wellington
School of Medicine, University of Otago,
Wellington, New Zealand.
Correspondence:
Christine.phillips@anu.edu.au
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Can clinical governance deliver quality improvement.pdf

  • 1. 602 MJA • Volume 193 Number 10 • 15 November 2010 REVIEW The Medical Journal of Australia ISSN: 0025-729X 15 November 2010 193 10 602-607 ©The Medical Journal of Australia 2010 www.mja.com.au Review mproving the quality of primary health care is a complex undertaking. Over the past decade, clinical governance has been promoted as a systematic, integrated approach to assuring safe, good quality health care.1 Its intent is to move beyond the organisational “magic bullet” of single strategies (eg, professional education, audit, or risk management) to a systematic, multifaceted approach to quality improve- ment using a range of locally implemented strategies. In Australia, most work on clinical gov- ernance has been in hospitals2 In the past 5 years, however, there has been an emerging interest in clinical governance in primary health care. Failures in health care delivery occur frequently in primary health care, just as they do in hospitals. In a study using anonymous reporting of adverse outcomes in Australian general practice, errors were estimated to occur in one in 1000 consulta- tions;3 of 433 errors, nearly 70% were attributed to failures in the processes of health care, and 30% to the failure of indi- vidual general practitioners’ knowledge and skills.4 Partly in response to this, the Royal Australian College of General Practitioners (RACGP) recently introduced clinical gov- ernance into its accreditation standards.5 The Victorian Healthcare Association has developed a range of resources and guide- lines for clinical governance in community health.6 Improving quality, safety, account- ability and performance is one of the four priorities in the draft national primary care strategy.7 The final report of the National Health and Hospitals Reform Commission (NHHRC) advocated strategies and infra- structure for quality improvement, and these are integral elements of the NHHRC’s recommendations on continuous learning, monitoring and interprofessional and inter- sectoral collaboration.8 Given the policy development in this area, there is a need to clarify models of clinical governance and the evidence relating them to quality improvement. Here, we review the literature on different models of clinical gov- ernance, exploring their relevance to the Aus- tralian primary care sector, and their potential impacts on quality and safety. METHODS The key question we examined was: What models of clinical governance deliver quality of care? We undertook a systematic review and realist synthesis of the literature.9 Realist synthesis is particularly relevant for complex social interventions, as it aims to develop explanatory analyses of why and how these interventions may work in particular settings and contexts. It is therefore relevant for policymakers who are keen to explore whether or not a model may work in a given context.10 Realist synthesis involves develop- ing theories and models of how mechanisms work, using careful analysis of the literature and interviews with stakeholders. We developed an operational definition of clinical governance by reviewing health pol- icy on clinical governance in Australia, the United Kingdom and New Zealand (Box 1). We also reviewed the seminal papers on clinical governance referenced in those pol- Can clinical governance deliver quality improvement in Australian general practice and primary care? A systematic review of the evidence Christine B Phillips, Christopher M Pearce, Sally Hall, Joanne Travaglia, Simon de Lusignan, Tom Love and Marjan Kljakovic ABSTRACT Objectives: To review the literature on different models of clinical governance and to explore their relevance to Australian primary health care, and their potential contributions on quality and safety. Data sources: 25 electronic databases, scanning reference lists of articles and consultation with experts in the field. We searched publications in English after 1999, but a search of the German language literature for a specific model type was also undertaken. The grey literature was explored through a hand search of the medical trade press and websites of relevant national and international clearing houses and professional or industry bodies. 11 software packages commonly used in Australian general practice were reviewed for any potential contribution to clinical governance. Study selection: 19 high-quality studies that assessed outcomes were included. Data extraction: All abstracts were screened by one researcher, and 10% were screened by a second researcher to crosscheck screening quality. Studies were reviewed and coded by four reviewers, with all studies being rated using standard critical appraisal tools such as the Strengthening the Reporting of Observational Studies in Epidemiology checklist. Two researchers reviewed the Australian general practice software. Interviews were conducted with 16 informants representing service, regional primary health care, national and international perspectives. Data synthesis: Most evidence supports governance models which use targeted, peer- led feedback on the clinician’s own practice. Strategies most used in clinical governance models were audit, performance against indicators, and peer-led reflection on evidence or performance. Conclusions: The evidence base for clinical governance is fragmented, and focuses mainly on process rather than outcomes. Few publications address models that enhance safety, efficiency, sustainability and the economics of primary health care. Locally relevant clinical indicators, the use of computerised medical record systems, regional primary health care organisations that have the capacity to support the uptake of clinical governance at the practice level, and learning from the Aboriginal community- MJA 2010; 193: 602–607 controlled sector will help integrate clinical governance into primary care. I 1 Definition of clinical governance used in this review • Clinical governance is a systematic and integrated approach to ensuring services are accountable for delivering quality health care. • Clinical governance is delivered through a combination of strategies including: ensuring clinical competence, clinical audit, patient involvement, education and training, risk management, use of information, and staff management. ◆
  • 2. MJA • Volume 193 Number 10 • 15 November 2010 603 REVIEW icy documents,11-16 and in the position doc- uments on systematised quality approaches in health care in the United States.17 Our definition of quality used the nine dimen- sions from the 2001 National Health Per- formance Framework18 (Box 2). Eligible studies Studies were included if they were identified through the search term “clinical govern- ance” or used a combination of strategies outlined in the definition to improve quality or accountability, and were either conducted in or applicable to the primary care sector. Studies were excluded if they focused on single strategies, or did not aim to improve quality or accountability. Search terms and strategy, and data analysis methods can be viewed in the complete report at http:// www.anu.edu.au/aphcri/Domain/Driv- ers%20of%20successful%20primary%20he alth%20care/Access_best_practice_policy_ options.pdf Information sources We searched 25 electronic databases, scan- ning reference lists of articles and consulta- tion with experts in the field. Our search was largely limited to publications in Eng- lish after 1999. A search of the German language literature for a specific model type was also undertaken on the recommenda- tion of a member of our international refer- ence group. The grey literature was explored through a hand search of the medical trade press and websites of relevant national and international clearing houses and profes- sional or industry bodies. Data extraction All abstracts were screened by one researcher, and 10% of abstracts were screened by a second researcher to cross- check screening quality. Studies were reviewed and coded by four reviewers using standardised data extraction sheets and a data dictionary to record study type and quality, health service type, elements of quality in health care and relevance to the Australian context. Indicators that a study might be relevant for the Australian context were: (i) heterogeneous services with differ- ent systems of funding and governance; (ii) cultural separation of medical professionals from bureaucracy; and (iii) loose networks of primary care services. We included well- theorised and contextualised case studies and descriptive studies. All studies were rated using standard critical appraisal tools such as the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)19 checklist. Two authors (C M P, S de L) also undertook a review of Australian general practice software for its potential contribution to clinical governance. Development of models of clinical governance and their relevance to Australia An iterative process was used to develop models of clinical governance suited to Aus- tralia, in which the mechanisms underpin- ning successful models were subjected to further review. Interviews were held with 16 key informants to review the relevance of the models and interrogate their feasibility. Interviewees were selected to illuminate clinical governance processes at: • the service level (managers and clinicians in four key clinical services identified by their peers as being experienced in clinical governance); • the regional level (representatives of regional health bodies — the Victorian Healthcare Association, a state-level Aborigi- nal service, National Aboriginal Community Controlled Health Organisation, Australian Primary Care Collaboratives, and Pegasus Health (a New Zealand not-for-profit organ- isation that supports 95 practices in the Christchurch/Canterbury area); and • the national level (representatives of accreditation bodies, GP education bodies, Kaiser Permanente [a US integrated man- aged care consortium], the UK General Med- ical Council, and the UK National Primary Care Research and Development Centre). Interviews (mean length, 57 minutes) were transcribed and coded using an emer- gent coding framework in NVivo, version 8.0 (QSR International, Melbourne, VIC). This study was approved by the Austral- ian National University Human Research Ethics Committee. RESULTS Eighty-seven studies were assessed as being of high quality (Box 3) and, of these, 19 explored the outcomes of clinical govern- ance. These 19 articles are the focus of this review. Seven were randomised controlled studies, 11 were longitudinal observational studies, and one was a well theorised and constructed case study. Six studies were from England,20-25 two from the US,26,27 four from Australia,28-31 two from New Zea- land,32,33 and one each from Spain,34 the Philippines,35 Belgium,36 and Germany.37 Only one study compared clinical govern- ance models in two countries, Holland and the US.38 Most studies addressed capability.20-23,25- 32,35-37 There were no studies that addressed continuity or appropriateness of care, and few that addressed responsiveness20,24,25,27,34,35 and accessibility.20,26,30,33,35 Only four studies addressed safety.24,25,31,37 Although many stud- ies explored incentive systems, very few 2 Quality dimensions (adapted from National Health Performance Framework, Australia 2001)18 Quality dimension Description Efficiency An individual or service can achieve desired results with the most cost-effective use of resources Effectiveness An individual or service can achieve desired health outcomes Capability An individual or service has the skills and knowledge to provide a health service Accessibility A service allows people to obtain health care irrespective of income, geography or cultural background Safety An individual or service avoids or reduces to acceptable limits the actual or potential harm from health care management Appropriateness An individual or service provides care, intervention or action that is relevant to the client’s needs and based on established standards Continuity An individual or service can provide uninterrupted, coordinated care or service over time Responsiveness An individual or service provides respect for persons and is client orientated Sustainability A service can provide infrastructure such as workforce, facilities and equipment to respond to current and emerging needs ◆
  • 3. 604 MJA • Volume 193 Number 10 • 15 November 2010 REVIEW described a clinical governance process, but rather posited a kind of black box between the incentive and the outcome. As a result, only four studies25,30-32 explored the relationship between clinical governance and efficiency. The models that emerged from the litera- ture and interviews are summarised in Box 4. The strategies most used were audit, performance against indicators, and peer-led reflection on evidence or performance. Assessment of clinical competence was described relatively infrequently in the stud- ies as a governance strategy; there are more articles describing the “enticement” of prac- titioners into clinical governance than “hard governance” measures like assessment of professional competence.39 Box 5 outlines the evidence for each model’s contribution to the quality domains. Interventions at different levels can improve capability of care, but this improvement appears to be related to the type of care and how easy it is to systematise care processes. Improvements in capability are more easily achieved in prescribing practice than in chronic disease management, where the evi- dence for improvement is varied and con- text-dependent. There are fewer data on effectiveness (ie, whether the intervention results in a measurable health improvement) than on capability (ie, whether the interven- tion results in an improvement in skills or practice), but in two uncontrolled studies, there was an improvement in the outcomes of chronic disease (angina,20 asthma20 and diabetes29 ) without an improvement in capability. Both these studies suggest that trends and/or unmeasured contextual effects lead to changes in outcomes irrespective of clinical governance measures. Most evidence supports governance mod- els which use targeted, peer-led feedback on the clinician’s own practice. There is less evidence supporting interventions across entire health systems, such as national level performance indicators, unless this is accompanied by appropriate levels of sup- port, including infrastructure support. Top- down models to drive quality improvement (external accreditation, or economic incen- tives for quality measures for doctors) resulted in no improvements in a range of 4 Description of clinical governance models Level at which the model operates Description of model Example Strategies used National level National benchmarking with or without regional-level development support United Kingdom Quality and Outcomes Framework Reporting against national performance indicators Regional level Collaboration with other clinicians or with community, with targeted feedback on practice Australian Primary Care Collaboratives; the National Aboriginal Community Controlled Health Organisation’s quality use of medicines program; New Zealand Pegasus Health’s peer-led networks Comparing practice or practitioner outcomes against one another; peer-to-peer education exercises Service level Practice-determined organisation of quality management, using targeted feedback to health care workers with supported reflection Audit and Best Practice for Chronic Disease (ABCD) project; Breakthrough Series methods Audit; small group reflection on practice Multilevel approaches National level benchmarking and incentive-setting, regional network support, and support for practice- level organisation using targeted feedback National Prescribing Service Audit; small group reflection; comparing data on individual practice with regional averages; national performance indicators 3 Data searching and inclusion flowchart Abstracts retrieved 3670 Complete article reviewed 639 High-quality case studies, observation and intervention studies 87 High-quality articles of relevance to Australia 54 Health care process studies 35 Exclude studies not relevant to Australian context 33 Articles that met inclusion criteria 317 Exclude poor-quality studies and all commentaries 220 Additional citations identified through reference list review 96 Additional citations identified through grey literature review 39 Outcome studies 19
  • 4. MJA • Volume 193 Number 10 • 15 November 2010 605 REVIEW quality domains, and in one country with limited resources (Philippines),35 led to a decline in accessibility. Sustainability may also deteriorate under a top-down model of governance without support and infrastruc- ture, a risk also noted at interview by work- ers within the Aboriginal health sector. Of the 11 software packages most com- monly used in Australian general practice, only four enable the user to participate in regional or aggregated data quality activities. No system had inbuilt data quality checks (eg, “How often are angiotensin-modulating drugs prescribed without renal function being checked?”). Most have some inbuilt searches for items that relate to funding initiatives or chronic disease management. The ability to do other searches was quite variable and often required significant com- puter and database knowledge. Only one package allowed patient access through a web portal, to which both the practice and the patient must have subscribed. Achieving some degree of standardisation may be an essential step in the implementation of clini- cal governance.40 An emerging theme in the interviews was the lack of clarity around the defini- tion and purpose of clinical governance. Concerns were expressed that the concept might denote governance of or by clini- cians, rather than strategic approaches to improving clinical care. There was resist- ance among professional groups to the idea of externally set performance indica- tors, which had the capacity to grow beyond indicators which would improve practice. The Aboriginal sector in Aus- tralia has pioneered the development of locally relevant performance indicators, and also reported on the organisational costs of reporting to multiple discon- nected performance indicators. Many interviewees commented on the difficul- ties of using information systems to best improve practice in Australia, with a great deal of energy being expended in extract- ing data from systems that did not intui- tively allow this. This was in contrast to other settings (eg, Kaiser Permanente, and Pegasus Health’s data on prescribing prac- tice), where regionalised aggregated data were available and could be compared with individual practitioners’ data. 5 Impact of models of clinical governance on quality Type of model Evidence for impact on quality May improve Conflicting or no evidence of impact May worsen Authors National level National benchmarking with regional level development support Accessibility; capability Responsiveness Campbell et al 200320 *† National external benchmarking with no regional level support Sustainability; responsiveness Gene-Badia et al 200734 Responsiveness; capability Accessibility Catacutan 200635‡ Regional level Collaboration with other GPs, with targeted feedback to improve practice Capability; safety Wensing et al 200437§ Effectiveness; capability; accessibility Landon et al 200426 * Collaboration with other GPs to improve practice, without targeted feedback Efficiency Capability; accessibility; effectiveness Scott and Coote 200730 Capability Van Driel 200736§ Collaboration with community to set clinical priorities and/or monitor services Accessibility Crampton et al 200533 Service level Practice-determined organisation of quality management, using targeted feedback to health care workers with supported reflection Effectiveness Capability Bailie et al 200729 * Effectiveness; capability Valk et al 200438 * Safety; responsiveness Fraser et al 200224§ Efficiency; safety; responsiveness; capability McKinnon 200125§ Capability Effectiveness Cranney et al 199922 * Capability Cheater et al 200623 * Capability Effectiveness Si et al 200728 * Effectiveness; responsiveness; capability Ornstein et al27 Effectiveness; capability Baker 200321 * Multilevel National level benchmarking and incentive-setting, regional network support, and support for practice-level organisation using targeted feedback Efficiency; capability Malcolm et al 200132§ Efficiency; capability Effectiveness; safety Beilby et al 200631§ * Chronic disease management. † Complex care (eg, care of older people, mental health). ‡ Curative services in developing countries. § Prescribing practice. ◆
  • 5. 606 MJA • Volume 193 Number 10 • 15 November 2010 REVIEW DISCUSSION The evidence in favour of clinical governance in general practice and primary care is frag- mented. The largest body of evidence relates to the areas that are most easily measured, such as the quality of prescribing practices. There is less evidence for quality improve- ment in chronic disease management and complex areas like health care for older people and mental health care. However, the development of outcome indicators in chronic and complex care is challenging, and the lack of evidence of the impact of clinical governance may reflect measurement diffi- culties rather than a genuine lack of impact. More research is needed into interventions to improve safety, sustainability, efficiency and responsiveness in primary care. The most acceptable mechanisms to drive clinical governance are those that recognise professional leadership and are perceived as being locally relevant and allowing reflec- tion on one’s own professional practice. There is a reasonable evidence base to sup- port the role of well resourced peer support networks to facilitate clinical governance. Clinical governance strategies that rely on guidelines alone have not proven effective among GPs. Performance indicators, clinical standards and guidelines — advocated in the Australian Government’s response to the NHHRC report,41 and in the draft National Primary Health Care Strategy7 — have a role in guided reflection and quality improve- ment. However, exclusive or excessive use of these top-down mechanisms can result in opportunity costs for the service,42 disrup- tion of teamwork if the reporting task is delegated,43 and constructing clinical activi- ties around indicators rather than need.44 An increase in the measurement of common chronic conditions that were the subject of incentives, over others that were not, was noted after the introduction of the Quality and Outcomes Framework in the UK.45 The Australian Government’s response to the NHHRC report proposed combining GPs and state-funded community health systems under the one regional structure, Primary Health Care Organisations (or Medicare Locals).41 This would provide a platform for regional networks to support clinical governance,46 and would presuma- bly build on structures such as the Divisions of General Practice network or Victoria’s Primary Care Partnerships. The UK experi- ence suggests that networks of practices interact to seek corroboration of the value of new information and evidence within local networks, before these practices establish patterns of clinical governance.47 Trust may be undermined if regional-level involvement in clinical governance is seen to be only the collection of data for reporting purposes. A central difficulty in introducing clinical governance is a lack of consensus among primary care workers about its meaning. Clinical governance remains a poorly under- stood term, often equated with bureaucratic control, or medical dominance.48 There is a need for regional or national organisations to display leadership in explaining and demon- strating what clinical governance actually involves. Examples of leaders in this area are the RACGP in their standards work and the work of the Victorian Healthcare Association. The Aboriginal community-controlled sector is in the vanguard of clinical govern- ance in Australia. The development of clini- cal indicators in some services (eg, Kimberley Aboriginal Medical Services49 ) preceded mainstream work in this area. Across the sector, there has been a concerted and long-term development of capacity and personnel to drive clinical governance activ- ities. The opportunity cost of resource-poor services directing personnel to data collec- tion for reporting purposes rather than for data translation to service improvement is also well understood within the sector. Input from this sector should be sought from others in Australia to inform the imple- mentation of clinical governance across all primary health care. The lack of good information on practice in Australia is a critical constraint for clinical governance activities. In some organisations in the US and New Zealand, regional net- works have access to detailed service-use data. In Australia, this level of feedback is only provided through the National Pre- scribing Service. In all other areas, specific clinical software is interrogated to generate routine data on individual practices, but the software itself is frequently insufficiently usable by service staff. As a minimum, serv- ice providers should have access to their own data on prescribing, tests ordered, referral patterns, and the demographic pat- terns and illnesses of their patients. Ready extraction of these data with a unified cod- ing system should be built into the stand- ards developed for clinical software. For clinical governance to become second nature in Australian primary care, health care practitioners need to be actively engaged as partners in quality improvement. The evidence is strongest for improvements that are driven by health professionals at the practice level, with support from regional networks. Such activity at regional and serv- ice levels needs support through structural changes initiated at the national level. This should include funding of time for clinical governance, supported by information sys- tems which provide ready access for practi- tioners to their own clinical data. ACKNOWLEDGEMENTS 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). We are grateful to members of the national and international refer- ence groups for their advice, and to Stefanie Webb and Friedrich Dengel for research support. The opinions expressed in this article are not the opin- ions of APHCRI or the Department of Health and Ageing. COMPETING INTERESTS Sally Hall is a member of the Board of APHCRI. AUTHOR DETAILS Christine B Phillips, MA, MPH, FRACGP, Associate Professor1 Christopher M Pearce, MFM, PhD, FRACGP, Deputy Chair2 Sally Hall, RN, Research Manager1 Joanne Travaglia, BSocWk, PhD, Research Fellow3 Simon de Lusignan, MB BS, MSc, MD(Res), Reader4 Tom Love, MPH, MSc, PhD, Senior Research Fellow5 Marjan Kljakovic, MB BS, PhD, Professor1 1 Academic Unit of General Practice and Community Health, Medical School, Australian National University, Canberra, ACT. 2 Melbourne East General Practice Network, Melbourne, VIC. 3 Centre for Clinical Governance and Health, Faculty of Medicine, University of New South Wales, Sydney, NSW. 4 Division of Community Health Sciences, St George’s — University of London, London, UK. 5 Department of General Practice, Wellington School of Medicine, University of Otago, Wellington, New Zealand. Correspondence: Christine.phillips@anu.edu.au REFERENCES 1 Government of Western Australia. Department of Health. Office of Safety and Quality in Healthcare. 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