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BMJ 2005;330:765 (2 April), doi:10.1136/bmj.38398.500764.8F (published 14 March 2005)
Kensaku Kawamoto, fellow1, Caitlin A Houlihan, scientist1, E Andrew Balas, professor and dean2, David F Lobach, associate professor1
1 Division of Clinical Informatics, Department of Community and Family Medicine, Box 2914, Duke University Medical Center, Durham, NC 27710, USA, 2 College of Health Sciences, Old Dominion University, Norfolk, VA 23529, USA
Correspondence to: David F Lobach david.lobach{at}duke.edu
Design Systematic review of randomised controlled trials.
Data sources Literature searches via Medline, CINAHL, and the Cochrane Controlled Trials Register up to 2003; and searches of reference lists of included studies and relevant reviews.
Study selection Studies had to evaluate the ability of decision support systems to improve clinical practice.
Data extraction Studies were assessed for statistically and clinically significant improvement in clinical practice and for the presence of 15 decision support system features whose importance had been repeatedly suggested in the literature.
Results Seventy studies were included. Decision support systems significantly improved clinical practice in 68% of trials. Univariate analyses revealed that, for five of the system features, interventions possessing the feature were significantly more likely to improve clinical practice than interventions lacking the feature. Multiple logistic regression analysis identified four features as independent predictors of improved clinical practice: automatic provision of decision support as part of clinician workflow (P < 0.00001), provision of recommendations rather than just assessments (P = 0.0187), provision of decision support at the time and location of decision making (P = 0.0263), and computer based decision support (P = 0.0294). Of 32 systems possessing all four features, 30 (94%) significantly improved clinical practice. Furthermore, direct experimental justification was found for providing periodic performance feedback, sharing recommendations with patients, and requesting documentation of reasons for not following recommendations.
Conclusions Several features were closely correlated with decision support systems' ability to improve patient care significantly. Clinicians and other stakeholders should implement clinical decision support systems that incorporate these features whenever feasible and appropriate.
Clinical decision support systems do not always improve clinical practice. In a recent systematic review of computer based systems, most (66%) significantly improved clinical practice, but 34% did not.1 Relatively little scientific evidence is available to explain why systems succeed or fail.10 11 Some investigators have tried to identify system features most important for improving clinical practice, but they have typically relied on the opinion of a limited number of experts, and none has combined a systematic literature search with quantitative meta-analysis. We therefore systematically reviewed the literature to identify the specific features of clinical decision support systems most crucial for improving clinical practice.
Inclusion and exclusion criteria
We defined a clinical decision support system as any electronic or non-electronic system designed to aid directly in clinical decision making, in which characteristics of individual patients are used to generate patient specific assessments or recommendations that are then presented to clinicians for consideration.1 Our inclusion criteria were any randomised controlled trial evaluating the ability of a clinical decision support system to improve an important clinical practice in a real clinical setting; use of the system by clinicians directly involved in patient care; and assessment of improvements in clinical practice through patient outcomes or process measures. Our exclusion criteria were less than seven units of randomisation per study arm; study not in English; mandatory compliance with decision support system; lack of description of decision support content or of clinician interaction with system; and score of less than five points on a 10 point scale assessing five potential sources of study bias.1
Study selection
Two authors independently reviewed the titles, index terms, and abstracts of the identified references and rated each paper as "potentially relevant" or "not relevant" using a screening algorithm based on study type, study design, subjects, setting, and intervention. Two authors then independently reviewed the full texts of the selected articles and again rated each paper as "potentially relevant" or "not relevant" using the screening algorithm. Finally, two authors independently applied the full set of inclusion and exclusion criteria to the potentially relevant studies to select the final set of included studies. Disagreements between reviewers were resolved by discussion, and we measured inter-rater agreement.
Data abstraction
A study may include several trial arms, so that multiple comparisons may exist within the single study. For each relevant comparison, two reviewers independently assessed whether the clinical decision support system resulted in an improvement in clinical practice that was both statistically and clinically significant. In some cases changes in practice characterised as clinically significant by the study authors were deemed non-significant by the reviewers.
Next, two reviewers independently determined the presence or absence of specific features of decision support systems that could potentially explain why a system succeeded or failed. We limited our consideration to features that were identified as being potentially important by at least three different sources from the literature, which left us with 22 potential explanatory features, including general system features, system-clinician interaction features, communication content features, and auxiliary features (see bmj.com). Of these, 15 could be included in our analysis because their presence or absence could be reliably abstracted from most studies.
Data synthesis
Univariate analysesFor each of the 15 selected features we individually determined whether interventions possessing the feature were significantly more likely to succeed than interventions lacking the feature. We calculated 95% confidence intervals for individual success rates and for differences in success rates.
Multiple logistic regression analysesFor these analyses, the presence or absence of a statistically and clinically significant improvement in clinical practice constituted the binary outcome variable, and the presence or absence of specific decision support system features constituted binary explanatory variables. We included only cases in which the clinical decision support system was compared against a true control group. (See bmj.com for details.)
Direct experimental evidenceWe systematically identified studies in which the effectiveness of a given decision support system was directly compared with the effectiveness of the same system with additional features. We considered a feature to have direct experimental evidence supporting its importance if its addition resulted in a statistically and clinically significant improvement in clinical practice.
The most common types of decision support system were computer based systems that provided patient-specific advice on printed encounter forms or on printouts attached to charts (34%), non-electronic systems that attached patient-specific advice to appropriate charts (26%), and systems that provided decision support within computerised physician order entry systems (16%).
Univariate analyses of clinical decision support system features
Overall, 48 of the 71 decision support systems (68% (95% confidence interval 56% to 78%)) significantly improved clinical practice. For five of the 15 features, the success rate of interventions possessing the feature was significantly greater than that of interventions lacking the feature (table 1).
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Interventions succeeded when the decision support was provided to clinicians automatically; when systems were provided as an integrated component of charting or order entry systems; when systems used a computer to generate the decision support; when systems prompted clinicians to record a reason when not following the advised course of action; and when systems provided a recommendation. Finally, systems that provided decision support at the point of care were substantially more likely to succeed than systems that did not, but the difference in success rates fell just short of being significant.
Meta-regression analysis
We conducted multivariate logistic regression analyses in order to identify independent predictors of clinical decision support system effectiveness while taking into consideration the presence of other potentially important factors (table 2).
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Of the six features shown to be important by the univariate analyses, four were identified as independent predictors of system effectiveness by the primary meta-regression analysis. Most notably, this analysis confirmed the critical importance of automatically providing decision support as part of clinician workflow. The other three features were providing decision support at the time and location of decision making, providing a recommendation rather than just an assessment, and using a computer to generate the decision support. Among the 32 clinical decision support systems incorporating all four features, 30 (94% (80% to 99%)) significantly improved clinical practice. In contrast, clinical decision support systems lacking any of the four features improved clinical practice in only 18 out of 39 cases (46% (30% to 62%)).
Survey of direct experimental evidence
We identified 11 randomised controlled trials in which a clinical decision support system was evaluated directly against the same clinical decision support system with additional features. In support of the regression results, one study found that system effectiveness was significantly enhanced when the decision support was provided at the time and location of decision making. Similarly, effectiveness was enhanced when clinicians were required to document the reason for not following system recommendations and when clinicians were provided with periodic feedback about their compliance with system recommendations. Furthermore, two of four studies found a significant beneficial effect when decision support results were provided to both clinicians and patients. In contrast, clinical decision support system effectiveness remained largely unchanged when critiques were worded more strongly and the evidence supporting the critiques was expanded to include institution-specific data, when recommendations were made more specific, when local clinicians were recruited into the system development process, and when bibliographic citations were provided to support the recommendations made by the system.
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Strengths and limitations of study
Strengths include our thorough literature search and systematic review for relevant expert opinion, the use of two independent reviewers for study selection and data abstraction to increase the reliability of our findings, provision of a quantitative estimate of the relative importance of specific clinical decision support system features and, finally, provision of a comprehensive summary of randomised controlled trials.
One limitation of this study is that we used a binary outcome measure rather than a continuous measure such as effect size. We therefore could not adjust for variations in the size of outcomes. Another potential criticism is that we pooled different types of clinical decision support systems in the regression analysis. However, we believe that our methods were appropriate given that our objective was to determine the impact of heterogeneity among interventions rather than to estimate the effects of a homogeneous intervention, as is usually the case for a meta-analysis.
Our analyses were limited to published reports of randomised controlled trials. Thus they may not be extendable to categories where we could not find any studies, such as those provided on personal digital assistants. Also, publication bias against studies that failed to show an effect might have limited our ability to identify features associated with ineffective systems.
The sample size for our regression analysis was restricted by the size of the available literature. Thus, our ratio of cases to explanatory variables was suboptimal, especially for the subset regression analyses. As a result, we cannot rule out the importance of system features based on their absence from the final regression models. Also, it is possible that one or more features were falsely included into the regression models because of over-fitting. However, our findings are consistent with our previous experiences of implementing clinical decision support systems in practice. An additional limitation is that our analyses were restricted to features that could be reliably abstracted.
Implications
On a practical level, our findings imply that clinicians should implement clinical decision support systems that (a) provide decision support automatically as part of clinician workflow, (b) deliver decision support at the time and location of decision making, (c) provide actionable recommendations, and (d) use a computer to generate the decision support. As a general principle our findings suggest that an effective clinical decision support system must minimise the effort required by clinicians to receive and act on system recommendations. When feasible and appropriate, clinical decision support systems should also provide periodic performance feedback, request documentation of the reason for not following system recommendations, and share decision support results with patients.
Future directions
The promise of evidence based medicine will be fulfilled only when strategies for implementing best practice are rigorously evidence based themselves. Two important research needs must still be addressed. Firstly, reports of clinical decision support system evaluations should provide as much detail as possible when describing the systems and the manner in which clinicians interacted with them, so that others can learn more effectively. Secondly, further direct experimentation is warranted to evaluate the importance of specific system features.
This is the abridged version of an article that was posted on bmj.com on 14 March 2005: http://bmj.com/cgi/doi/10.1136/bmj.38398.500764.8F
We thank Vic Hasselblad for his assistance with the statistical analyses.
Contributors and guarantor: See bmj.com
Funding: This study was supported by research grants T32-GM07171 and F37-LM008161-01 from the National Institutes of Health, Bethesda, Maryland, USA; and by research grants R01-HS10472 and R03-HS10814 from the Agency for Healthcare Research and Quality, Rockville, Maryland, USA. These funders did not play a role in the design, execution, analysis, or publication of this study.
Competing interests: None declared.
Ethical approval: Not required.
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