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What context features might be
important determinants of the
effectiveness of patient safety practice
interventions?
Stephanie L Taylor,
1,2
Sydney Dy,
3
Robbie Foy,
4
Susanne Hempel,
1
Kathryn M McDonald,
5
John Øvretveit,
6
Peter J Pronovost,
3
Lisa V Rubenstein,
1,2
Robert M Wachter,
7
Paul G Shekelle
1,2
ABSTRACT
Background: Differences in contexts (eg, policies,
healthcare organisation characteristics) may explain
variations in the effects of patient safety practice (PSP)
implementations. However, knowledge of which
contextual features are important determinants of PSP
effectiveness is limited and consensus is lacking on
a taxonomy of which contexts matter.
Methods: Iterative, formal discussions were held with
a 22-member technical expert panel composed of
experts or leaders in patient safety, healthcare
systems, and methods. First, potentially important
contextual features were identified, focusing on five
PSPs. Then, two surveys were conducted to determine
the context likely to influence PSP implementations.
Results: The panel reached a consensus on a taxonomy
of four broad domains of contextual features important
for PSP implementations: safety culture, teamwork
and leadership involvement; structural organisational
characteristics (eg, size, organisational complexity or
financial status); external factors (eg, financial or
performance incentives or PSP regulations); and
availability of implementation and management tools
(eg, training organisational incentives). Panelists also
tended to rate specific patient safety culture, teamwork
and leadership contexts as high priority for assessing
their effects on PSP implementations, but tended to
rate specific organisational characteristic contexts as
high priority only for use in PSP evaluations. Panelists
appeared split on whether specific external factors and
implementation/management tools were important for
assessment or only description.
Conclusion: This work can guide research
commissioners and evaluators on the contextual
features of PSP implementations that are important to
report or evaluate. It represents a first step towards
developing guidelines on contexts in PSP
implementation evaluations. However, the science of
context measurement needs maturing.
INTRODUCTION
Many practices have been implemented to
improve the safety of patients, such as use of
a checklist to prevent blood stream infec-
tions. The effectiveness of these patient safety
practices (PSPs) can vary markedly between
different settings. Such variations in effec-
tiveness are likely to be attributable to varia-
tions in a range of contextual factors
affecting the implementation of PSPs, such as
policies, regulations, or organisational char-
acteristics.
1e10
That is, some contexts are
likely to affect the effectiveness of PSP
implementations. However, as Eccles and
colleagues (2009) noted, despite the effect
that context can have on PSP implementa-
tion, ‘the role of context in intervention
development needs to be better under-
stood’.
1
The lack of understanding in the
field of patient safety is especially evident
when considering the role that particular
contextual factors have on PSP interventions.
Our lack of understanding could in part be
due to the complex nature of contexts. That
is, the importance of particular context
features might depend on the infancy or
maturity of the PSP being implemented, the
stage of the PSP implementation, the specific
component when considering multi-compo-
nent PSPs, the level at which the PSP is
targeted (eg, national-level, hospital-level or
unit-level efforts), and the type of PSP (ie,
some contexts may be somewhat PSP
specific). Our poor understanding of the
effects of contextual factors on PSP inter-
ventions also could be because of the paucity
of empirical evaluations of the issue,
1
RAND Corporation, Santa
Monica, California, USA
2
Veterans Administration,
Greater Los Angeles, Los
Angeles, California, USA
3
The Johns Hopkins
University School of
Medicine, Baltimore,
Maryland, USA
4
Leeds Institute of Health
Sciences University of Leeds,
Leeds, UK
5
Stanford University,
Stanford, California, USA
6
Medical Management
Centre, The Karolinska
Institutet, Stockholm,
Sweden
7
University of California, San
Francisco, California, USA
Correspondence to
Stephanie L Taylor, VA
Greater Los Angeles, 16111
Plummer St., Bldg. 25 (152),
North Hills, CA 91343, USA;
stephanie.taylor8@va.gov
Accepted 1 April 2011
Published Online First
26 May 2011
BMJ Qual Saf 2011;20:611e617. doi:10.1136/bmjqs.2010.049379 611
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although contextual factors have been widely examined
in the organisational science and business management
fields.
11 12
For us to better understand the effects of context on
implementations, some contexts should be measured
and analytically assessed. However, as Øvretveit and
colleagues report, few studies assess the effect of context
on PSP implementation and many studies only describe
a few contexts.
13
Some exceptions exist. For example, as
part of the evaluation. For example, as part of the eval-
uation of the Agency for Healthcare Research and
Quality’s (AHRQ) patient safety contract portfolio, one
study found that AHRQ grantees of health information
technology implementations tended to report several
contextual factors as contributing to their implementa-
tions’ success: commitment from top management,
dedicated staff and financial resources, an open process
to encourage buy-in and enthusiasm by end users, and
sheer persistence.
14
Another study conducted as part of
that evaluation reported on several structural compo-
nents that AHRQ patient safety grantees considered
essential to being in place prior to implementation, such
as an institutional commitment and leadership, trust
among participating stakeholders, a supportive organ-
isational culture, and prior experience with perfor-
mance improvement.
15
Although a few additional
studies specifically focused on patient safety
16
or other
types of intervention implementations have examined
the effect of context,
17 18
most do not.
Another potential reason we understand less than we
do about the role of contextual factors on PSP imple-
mentations is that many evaluations report only basic
information on contextual features. For example,
a review of health information technology studies found
that the interventions’ contextual features were poorly
described.
19
Additionally, a recent paper noted that
many published reports of clinical interventions in
general fail to adequately describe the context in which
interventions are implemented such that there is inad-
equate information for replication and/or implementa-
tion.
20
Similarly, an analysis of quality improvement
strategies identified a need for more detailed descrip-
tions of both interventions and contextual features to
inform interpretation, replication and local adaptation
when choosing potential intervention strategies for
particular circumstances.
21
This would allow readers to
answer the question, ‘Is this intervention likely to work
in our circumstances?’
However, it is difficult to prioritise which contextual
features to assess or only describe if there is a poor
understanding of which contextual features are likely to
modify the effectiveness of a PSP intervention. Given
that such a wide range of contextual features exist, it is
important to avoid calls for the reporting of more and
more contextual features to an excessive level of detail,
which risks paralysing researchers and readers alike.
Therefore, the challenge is to identify which contextual
featuresdgiven our current level of understandingdare
most likely to inform understanding and generalisability.
Admittedly, some contextual features are generally
thought to be important (eg, having a culture of safety
and leadership support) but the patient safety field is far
from in agreement on whether these are specific to
safety issues or any organisational change effort in
general and what other types of patient, hospital unit,
hospital, or external contextual features are important
enough to assess or at least describe in research papers.
In sum, the role of contextual features in PSP imple-
mentations appears important, although there is little
evidence or consensus around which contexts are the
most salient for PSP implementations, subsequently
hindering the generalisability and reporting of evalua-
tions. The authors addressed this gap by presenting the
conceptual domains of contexts and the specific
contextual features within those domains that experts
considered high priority for assessment or description.
Experts were asked to distinguish between assessing the
effects of contextual features and only describing
contextual features in research papers. If researchers
more richly describe the contexts in which PSP inter-
ventions are implemented, it might enhance readers’
ability to determine if the study is likely to work in their
own set of circumstances. However, assessing some
potentially important contexts might help move the field
forward by building the evidence for the importance of
some contextual features to PSP implementations.
METHODS
Throughout the study, the authors used an iterative
process of formal group discussions with a 22-member
technical expert panel composed of patient safety
experts, clinical and healthcare system leaders, and
methodological experts.These discussions were based on
the results of targeted literature reviews and two surveys,
with the purpose of identifying which contextual
features are likely to have most relevance to and impact
upon a diverse range of five PSP’s. We used an expert
panel, given that the issue of the importance of context
in patient safety is relatively nascent. It was formed as
part of a larger study and was composed of international
experts in specific patient safety practices; methodolo-
gists from fields including epidemiology and statistics,
program evaluation, organisational behaviour and
human factors engineering; senior health system exec-
utives responsible for implementing safety practices; and
leaders of national and international patient safety
organisations. Throughout this study, an iterative
612 BMJ Qual Saf 2011;20:611e617. doi:10.1136/bmjqs.2010.049379
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deliberative process with the panelists was used,
involving structured discussions (first by telephone and
then face-to-face) and two surveys.
Selection of PSPs
The authors grounded their efforts to select contextual
features using five diverse and representative PSPs. To
select the PSPs, a list of possible PSPs was generated from
a variety of sources, including the AHRQ Evidence-based
Practice Report Making Health Care Safer
22
, the National
Quality Forum’s Safe Practices 2009 update,
23
and input
from relevant organisations including AHRQ and the
Institute for Healthcare Improvement.
24
Through an
iterative process of developing a framework to classify
PSPs based on their diversity and representativeness, and
based on input from the expert panel, five PSPs were
selected:
25
1. the universal protocol to prevent wrong site, wrong
procedure, wrong person surgery;
2. medication reconciliation;
3. computer physician order entry and computer
decision support systems;
4. practices designed to reduce the rate and risk of falls;
and
5. use of a checklist to prevent blood stream infections.
These were representative of PSPs in different settings
(eg, hospitals, clinics and nursing homes), and
addressed both PSPs that were subject to regulatory
authority and those that were not, and those that were
aimed at preventing very rare and those that targeted
more common safety events.
Selection of initial set of contexts and first survey
To guide the panelist discussion and surveys, first, a list
was compiled of contextual features reported in seminal
PSP papers and these were grouped into nine broad
conceptual domains. The authors recognised that some
contexts might affect the implementation of only some
PSPs while other contexts might affect the interventions
of most PSPs. Given the long list of potential contexts
that could have been examined, the authors tried to
examine those contexts that might be important to many
PSPs. (However, the panelists were specifically asked in
the second survey (table 1)which of the five PSPs each
context might be important to.) Also, some of the
context features could be considered interventions
(eg, the presence of information systems and decision
support). When these already exist across both inter-
vention and control sites in an experimental design, and
the intervention being evaluated is independent of or
additive to them, such features represent part of the
contextual background to the evaluation. Given the
purpose of this study was to examine how context might
affect PSP implementations, the panelists’ discussions
and survey responses of contexts were based on the
features as contexts and not part of the intervention.
The authors then discussed the domains and the
specific contextual features during the first meeting with
the panelists to help determine on which features
panelists should be surveyed. After the meeting, a web
survey was used to ask the panelists to rate the relative
Table 1 Contexts judged as high priority for assessing (A)
their effects on PSP implementations or only for describing
(D) in papers
Response options were: 1. yes, it is a high priority for assessing the
influence of context on the success of that implementation, 2. yes, it
is a high priority only for describing the contexts, and 3. no, it is not
a high priority. U¼more than 33% of experts reported this
response (the responses were qualitatively greater than chance, so
if a context is not checked, more than 33% of respondents did not
think the context was a high priority).
Shaded items were not included in the survey for that particular
PSP given they were less relevant.
IT, information technology; org, organization; PSP, patient safety
practice; universal protocol, for preventing wrong procedure, wrong
site, wrong person surgery; bloodstream infection checklist,
catheter related.
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importance of the contextual features to each of the five
PSPs, from ‘not very important’, ‘important’, ‘extremely
important’, to ‘important or extremely important only in
some settings’, and to ask them to consider nursing
home, inpatient, outpatient, and community settings.
The purpose of the first survey was to guide the devel-
opment of the second survey and the context taxonomy
(as described below).
Development of the context taxonomy
A taxonomy of important contextual features was
developed using the features that were rated in the first
survey as ‘important’ across all five PSPs or ‘very
important’ across four or five PSPs. Lower scoring
contextual features, while acknowledged as potentially
important, were not discussed further. This taxonomy
was first proposed by the project team and then
discussed and agreed upon by the panelists as an easy
way to conceptualise the various types of contexts that
might affect PSP implementations. The panelist
exchanges also resulted in some contextual features
being divided into more homogenous groups and other
new features being added and included in the second
survey.
Second survey
The authors held a second intensive discussion about
contexts with panelists and based on this discussion and
the results of the first survey, a second web survey was
designed for panelists to prioritise the list of contextual
features. For each feature, the following question was
asked: ‘Is it a high priority to collect data on [context]
for describing the context and/or for assessing the effect
of context on this PSP implementation?’ Response
options were: 1. yes, it is a high priority for assessing the
influence of context on the success of that imple-
mentation, 2. yes, it is a high priority only for describing
the contexts, and 3. no, it is not a high priority. Both this
survey and the first survey had a 95% (n¼22) response
rate. The authors conducted a descriptive analysis
(frequencies) on the results of the surveys.
RESULTS
Box 1shows the 42 contextual features mentioned in the
seminal PSP papers and how the project team organised
them into nine conceptual domains. One of these
domains was labeled ‘cultural organisational factors’, and
one of the contexts within that domain was ‘safety
culture’. It is worth noting that there are numerous
definitions of organisational culture in general,
26 27
including the informal ‘the way we do things around
here’. On safe culture specifically, Pronovost and Sexton
28
suggest that, ‘In a safe culture employees are guided by an
organisation-wide commitment to safety in which each
member upholds their own safety norms and those of
their co-workers.’ When the panelists reviewed this list,
they had a lively discussion on what contexts might affect
Box 1 Contexts mentioned in published seminal
evaluations of patient safety practices (PSPs)
-External environmental factors
– External PSP-related regulations or policies
– Rural versus urban environment
– Geographic location other than rural/urban
– Medical payment environment
– External incentives/motivators
-Structural organisational demographics
– Unit or organisational characteristic
– Academic affiliation
– Organisational size
– Organisational affiliations other than academics
– Economic status
– Structural complexity
– Internal organisational incentives
-Cultural organisational factors
– Safety culture
– Teamwork
– Innovativeness
– Readiness for change
– Need for change
-Collaboration, resources and leadership
– Collaboration across healthcare professionals
– Collaboration with health services researchers
– Collaboration with quality improvement experts or
facilitators
– Quality improvement or innovations funding
– Leadership involvement
-The presence of information systems and decision
support
– Information systems
– Electronic medical record
– Computer reminders
– Guidelines
– Training resources
-Care coordination, management and patient self-
management
– Care coordination
– Care management
-Delivery system design
– Professional staffing
-Provider knowledge, attitude and skills
– Knowledge/skill
– Patient safety or quality improvement knowledge/skill
– Attitudes
– Evidence base
– Ease of adoption
– Type of healthcare provider
-Patient and encounter complexity elements
– Patient clinical complexity
– Patient attitudes
– Patient activation/engagement
– Urgency of the patient/clinician encounter
– Continuity of patient/clinician encounter
– Patient transitions
614 BMJ Qual Saf 2011;20:611e617. doi:10.1136/bmjqs.2010.049379
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PSP implementations. Some argued for using theory on
which to select contexts because so little work has been
done to determine which contexts are important; others
acknowledged that some of the contexts mentioned could
be part of the intervention in some circumstances, but
recognised that our discussions would focus on the situ-
ations when those context features were external to the
intervention; others mentioned that work has been done
in other fields such as human factors and business
management to examine the effect of contexts; and
another panelist felt that ‘context’ should include
anything one needs to know to replicate the study. The
panelists agreed that our survey should include most of
the contexts on our proposed list and they suggested a few
additional contexts.
The results of the first survey showed the panel
considered 19 of the 42 contextual features as important
or extremely important across the PSPs. The results of
this survey and discussion with the experts were then
used to shape the second survey (as noted below). The
results were also used to develop a taxonomy of four
conceptual domains of contextual features that are
important for PSP implementations, as shown in box 2.
When the panelists were presented with the results of the
first survey, they agreed with the results. However, based
on the results, the panelists also thought that the second
survey should ask them about a few additional contexts
and that the group of contexts should continue to be
diverse in terms of their degree of universality, how
tactical, psychosocial or mutable the contexts are, how
much empirical evidence exists for the contexts’
importance, and the number of PSPs to which the
contexts related.
The results of the second panelist survey on the
priority of a modified list of contextual features are
shown in table 1.Panelists tended to rate the six patient
safety culture, teamwork and leadership contexts as high
priority for assessing their effects on PSP implementa-
tions rather than for only describing these features in
evaluations or not a priority at all. One exception to this
pattern is noteworthy: panelists tended to report that
patient safety culture at the level of the hospital or clinic
organisation is important only for describing in studies
(not for assessing their effect). Moreover, in post-survey
discussions with the panelists, they recognised that the
items in the patient safety culture/teamwork/leadership
domain likely represent distinct attributes of context.
Panelists tended to rate the 12 structural organisa-
tional characteristic contexts (eg, size or location), as
high priority only for describing in PSP evaluations.
However, again, two organisational contextual features
were noteworthy exceptions: at least a third reported it
was a high priority to assess the effects of existing quality/
safety infrastructure and organisational complexity on
PSP implementations.
For the five external contexts (eg, regulatory require-
ment and payments or penalties) and the 11 imple-
mentation or management tools (eg, internal incentives
and staff training), panelists appeared somewhat split
overall on whether the contexts are a high priority for
assessment or a priority only description in evaluations.
Finally, of all the contexts examined, panelists tended
to report that only two are not a high priority at all (not
for describing or assessing): teamwork at the organisa-
tional level (for bloodstream infection checklists and for
the universal protocol) and marketplace competition
(for bloodstream infection checklists).
DISCUSSION
This paper reports on the use iterative, formal discus-
sions with a 22-member technical expert panel
comprised of experts or leaders in patient safety,
healthcare systems, and methods to determine what
contexts are likely to have major influences on PSP
implementations and which should be described in PSP
evaluations. Given a long list of potentially important
contextual features, the experts were able to reach
agreement that four conceptual domains of contexts,
and some specific contextual features within those
domains, are important.
This study has several strengths, including the use of
a heterogeneous, interdisciplinary panel of experts and
the opportunity to have both face-to-face and telephone
meetings with them to iteratively and intensely delib-
erate the contexts that might be important for patient
safety interventions. Perhaps the biggest strength of this
paper is that it aims to help build the consensus that has
been lacking, given the infancy of the field, and creates
categories of context that can be the focus of future
research.
The limitations of this study include our potential
omission of some contextual features that others
consider important for assessing PSP interventions or for
describing in evaluations. Admittedly, the process by
which the contexts were selected and the opinions of the
panelists were subjective, such that another set of experts
Box 2 Results of first survey: four domains of contexts
judged as important for patient safety practices (PSPs)
-Safety culture, teamwork and leadership involvement.
-Structural organisational characteristics (eg, size,
organisational complexity or financial status).
-External factors (eg, financial or performance incentives
or PSP regulations).
-Availability of implementation and management tools
(eg, training resources or internal organisational
incentives).
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might have derived a different set of context domains
than the ones derived here. It is likely that the panelists’
academic background, degree of medical experience,
and other factors affected their decisions. However, the
authors intentionally selected a heterogeneous group of
panelists so that their overall opinions would be
balanced. In addition, the taxonomy was not validated.
However, the efforts presented in this paper should be
considered the first step in a longer-term, iterative
process of subsequent research. Of course, there is as yet
scant evidence that the contexts selected actually do
influence the effectiveness of patient safety interven-
tions. However, the purpose of this study was to try
and get the field to focus their measurement and
reporting on those contexts believed to be potentially
the most important. It is only by getting patient safety
evaluators to focus on a common set of contexts that an
evidence base can be built about which contexts really
are importantdthe authors expect a future version of
this process, informed by better evidence, to refine this
list of contexts, possibly dropping some and adding
new ones.
Several contextual factors within four conceptual
domains of contexts were found to be important. Readers
familiar with the evidence-based medicine literature
might wonder about the applicability of the ‘PICO’
framework
29
for categorising contexts as an alternative.
In that framework, study questions are categorised into
population, intervention, comparison group, and
outcome groups (PICO). That appears to be a useful
framework for categorising some contexts. For example,
the ‘population’ category could include contexts that are
characteristics of the organisational target group (eg,
culture, teamwork, leadership) and setting (eg, structural
organisational characteristics and external factors).
However, the ‘intervention’ category in the PICO
framework could include many of the contexts examined
here because many could be the focus of an intervention.
Likewise, the ‘comparison’ category in the PICO frame-
work could include almost any context in the group not
receiving the PSP intervention. The ‘outcome’ category
might be less applicable to the contexts examined here.
As such, the PICO framework might not lend itself to the
efficient categorisation of contexts.
The authors suggest future PSP implementation
studies measure, describe, and perhaps assess the effects
of the contextual features that experts reported in this
paper as high priority. Assessing some potentially
important contexts would help build the evidence for
the importance of some contextual features. If future
evaluations more richly described the contexts in which
PSP interventions took place, using some of the
contextual features mentioned here, readers might be
better able determine if the study is likely to work in
their own set of circumstances. Guidelines such as
CONSORT
30
and SQUIRE
31 32
have already been
developed for reporting interventions. Perhaps these or
other existing guidelines can be modified to include the
reporting of contextual features when PSP imple-
mentations are reported. The results presented here
could be the first step towards that effort.
Readers of research papers on PSP implementations
need to know about context factors but also about the
rigour of study design to draw conclusions about effec-
tiveness. The technical expert panel and this paper
focused on the first of these considerations, however
additional research is needed to address the second.
Also, despite consensus on the context domains
presented here, the existing literature suggests the
ability to accurately measure the contextual features
comprising these domains is immature. Although the
authors encourage researchers to describe or assess
several contextual features in evaluations, they recognise
the need for ‘basic research’ in patient safety to advance
the science of measuring the contextual features.
Funding Agency for Healthcare Research and Quality.
Competing interests None declared.
Contributors The technical expert panel included Alyce S. Adams, PhD, Peter
Angood, MD, David W. Bates, MD, MSc, Len Bickman, PhD, Celia Brown, PhD,
Pascale Carayon, PhD, Sir Liam Donaldson, MD, Naihua Duan, PhD, Donna O.
Farley, PhD, MPH, Trisha Greenhalgh, MD, John Haughom, MD, Eileen T. Lake,
PhD, RN, Richard Lilford, MB BCh, PhD, Kathleen N. Lohr, PhD, Gregg S.
Meyer, MD, MSc, Marlene Miller, MD, MSc, Duncan Neuhauser, PhD, Gery
Ryan, PhD, Sanjay Saint, MD, MPH, Kaveh Shojania, MD, Stephen M. Shortell,
PhD, MPH, David P. Stevens, MD, and Kieran Walshe, PhD. The research
reported here was supported under Contract No. HHSA-290-2009-10001C
from the Agency for Healthcare Research and Quality, US Department of
Health and Human Services. The authors of this paper are responsible for its
content. Statements in this paper should not be construed as endorsement by
the Agency for Healthcare Research and Quality or the US Department of
Health and Human Services.
Provenance and peer review Not commissioned; externally peer reviewed.
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2011 2011 20: 611-617 originally published online May 26,BMJ Qual Saf
Stephanie L Taylor, Sydney Dy, Robbie Foy, et al.
safety practice interventions?
determinants of the effectiveness of patient
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