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Computerized clinical decision support systems for therapeutic drug monitoring and dosing: a decision-maker-researcher partnership systematic review.

ABSTRACT: Some drugs have a narrow therapeutic range and require monitoring and dose adjustments to optimize their efficacy and safety. Computerized clinical decision support systems (CCDSSs) may improve the net benefit of these drugs. The objective of this review was to determine if CCDSSs improve processes of care or patient outcomes for therapeutic drug monitoring and dosing.We conducted a decision-maker-researcher partnership systematic review. Studies from our previous review were included, and new studies were sought until January 2010 in MEDLINE, EMBASE, Evidence-Based Medicine Reviews, and Inspec databases. Randomized controlled trials assessing the effect of a CCDSS on process of care or patient outcomes were selected by pairs of independent reviewers. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.Thirty-three randomized controlled trials were identified, assessing the effect of a CCDSS on management of vitamin K antagonists (14), insulin (6), theophylline/aminophylline (4), aminoglycosides (3), digoxin (2), lidocaine (1), or as part of a multifaceted approach (3). Cluster randomization was rarely used (18%) and CCDSSs were usually stand-alone systems (76%) primarily used by physicians (85%). Overall, 18 of 30 studies (60%) showed an improvement in the process of care and 4 of 19 (21%) an improvement in patient outcomes. All evaluable studies assessing insulin dosing for glycaemic control showed an improvement. In meta-analysis, CCDSSs for vitamin K antagonist dosing significantly improved time in therapeutic range.CCDSSs have potential for improving process of care for therapeutic drug monitoring and dosing, specifically insulin and vitamin K antagonist dosing. However, studies were small and generally of modest quality, and effects on patient outcomes were uncertain, with no convincing benefit in the largest studies. At present, no firm recommendation for specific systems can be given. More potent CCDSSs need to be developed and should be evaluated by independent researchers using cluster randomization and primarily assess patient outcomes related to drug efficacy and safety.

SUBMITTER: Nieuwlaat R

PROVIDER: S-EPMC3170236 | biostudies-other | 2011 Aug

REPOSITORIES: biostudies-other

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Computerized clinical decision support systems for therapeutic drug monitoring and dosing: a decision-maker-researcher partnership systematic review.

Nieuwlaat Robby R Connolly Stuart J SJ Mackay Jean A JA Weise-Kelly Lorraine L Navarro Tamara T Wilczynski Nancy L NL Haynes R Brian RB

Implementation science : IS 20110803

<h4>Background</h4>Some drugs have a narrow therapeutic range and require monitoring and dose adjustments to optimize their efficacy and safety. Computerized clinical decision support systems (CCDSSs) may improve the net benefit of these drugs. The objective of this review was to determine if CCDSSs improve processes of care or patient outcomes for therapeutic drug monitoring and dosing.<h4>Methods</h4>We conducted a decision-maker-researcher partnership systematic review. Studies from our previ ...[more]

PMID: 21824384

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Project description:BackgroundThe use of computerized clinical decision support systems (CCDSSs) may improve chronic disease management, which requires recurrent visits to multiple health professionals, ongoing disease and treatment monitoring, and patient behavior modification. The objective of this review was to determine if CCDSSs improve the processes of chronic care (such as diagnosis, treatment, and monitoring of disease) and associated patient outcomes (such as effects on biomarkers and clinical exacerbations).MethodsWe conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for potentially eligible articles published up to January 2010. We included randomized controlled trials that compared the use of CCDSSs to usual practice or non-CCDSS controls. Trials were eligible if at least one component of the CCDSS was designed to support chronic disease management. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of relevant outcomes.ResultsOf 55 included trials, 87% (n = 48) measured system impact on the process of care and 52% (n = 25) of those demonstrated statistically significant improvements. Sixty-five percent (36/55) of trials measured impact on, typically, non-major (surrogate) patient outcomes, and 31% (n = 11) of those demonstrated benefits. Factors of interest to decision makers, such as cost, user satisfaction, system interface and feature sets, unique design and deployment characteristics, and effects on user workflow were rarely investigated or reported.ConclusionsA small majority (just over half) of CCDSSs improved care processes in chronic disease management and some improved patient health. Policy makers, healthcare administrators, and practitioners should be aware that the evidence of CCDSS effectiveness is limited, especially with respect to the small number and size of studies measuring patient outcomes.

Project description:Underuse and overuse of diagnostic tests have important implications for health outcomes and costs. Decision support technology purports to optimize the use of diagnostic tests in clinical practice. The objective of this review was to assess whether computerized clinical decision support systems (CCDSSs) are effective at improving ordering of tests for diagnosis, monitoring of disease, or monitoring of treatment. The outcome of interest was effect on the diagnostic test-ordering behavior of practitioners.We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for eligible articles published up to January 2010. We included randomized controlled trials comparing the use of CCDSSs to usual practice or non-CCDSS controls in clinical care settings. Trials were eligible if at least one component of the CCDSS gave suggestions for ordering or performing a diagnostic procedure. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of test ordering outcomes.Thirty-five studies were identified, with significantly higher methodological quality in those published after the year 2000 (p = 0.002). Thirty-three trials reported evaluable data on diagnostic test ordering, and 55% (18/33) of CCDSSs improved testing behavior overall, including 83% (5/6) for diagnosis, 63% (5/8) for treatment monitoring, 35% (6/17) for disease monitoring, and 100% (3/3) for other purposes. Four of the systems explicitly attempted to reduce test ordering rates and all succeeded. Factors of particular interest to decision makers include costs, user satisfaction, and impact on workflow but were rarely investigated or reported.Some CCDSSs can modify practitioner test-ordering behavior. To better inform development and implementation efforts, studies should describe in more detail potentially important factors such as system design, user interface, local context, implementation strategy, and evaluate impact on user satisfaction and workflow, costs, and unintended consequences.

Project description:BackgroundComputerized clinical decision support systems (CCDSSs) are claimed to improve processes and outcomes of primary preventive care (PPC), but their effects, safety, and acceptance must be confirmed. We updated our previous systematic reviews of CCDSSs and integrated a knowledge translation approach in the process. The objective was to review randomized controlled trials (RCTs) assessing the effects of CCDSSs for PPC on process of care, patient outcomes, harms, and costs.MethodsWe conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews Database, Inspec, and other databases, as well as reference lists through January 2010. We contacted authors to confirm data or provide additional information. We included RCTs that assessed the effect of a CCDSS for PPC on process of care and patient outcomes compared to care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.ResultsWe added 17 new RCTs to our 2005 review for a total of 41 studies. RCT quality improved over time. CCDSSs improved process of care in 25 of 40 (63%) RCTs. Cumulative scientifically strong evidence supports the effectiveness of CCDSSs for screening and management of dyslipidaemia in primary care. There is mixed evidence for effectiveness in screening for cancer and mental health conditions, multiple preventive care activities, vaccination, and other preventive care interventions. Fourteen (34%) trials assessed patient outcomes, and four (29%) reported improvements with the CCDSS. Most trials were not powered to evaluate patient-important outcomes. CCDSS costs and adverse events were reported in only six (15%) and two (5%) trials, respectively. Information on study duration was often missing, limiting our ability to assess sustainability of CCDSS effects.ConclusionsEvidence supports the effectiveness of CCDSSs for screening and treatment of dyslipidaemia in primary care with less consistent evidence for CCDSSs used in screening for cancer and mental health-related conditions, vaccinations, and other preventive care. CCDSS effects on patient outcomes, safety, costs of care, and provider satisfaction remain poorly supported.

Project description:BACKGROUND: Therapeutic drug monitoring of phenytoin by measurement of plasma concentrations is often employed to optimize clinical efficacy while avoiding adverse effects. This is most commonly accomplished by measurement of total phenytoin plasma concentrations. However, total phenytoin levels can be misleading in patients with factors such as low plasma albumin that alter the free (unbound) concentrations of phenytoin. Direct measurement of free phenytoin concentrations in plasma is more costly and time-consuming than determination of total phenytoin concentrations. An alternative to direct measurement of free phenytoin concentrations is use of the Sheiner-Tozer equation to calculate an adjusted phenytoin that corrects for the plasma albumin concentration. Innovative medical informatics tools to identify patients who would benefit from adjusted phenytoin calculations or from laboratory measurement of free phenytoin are needed to improve safety and efficacy of phenytoin pharmacotherapy. The electronic medical record for an academic medical center was searched for the time period from August 1, 1996 to November 30, 2010 for patients who had total phenytoin and free phenytoin determined on the same blood draw, and also a plasma albumin measurement within 7 days of the phenytoin measurements. The measured free phenytoin plasma concentration was used as the gold standard. RESULTS: In this study, the standard Sheiner-Tozer formula for calculating an estimated (adjusted) phenytoin level more frequently underestimates than overestimates the measured free phenytoin relative to the respective therapeutic ranges. Adjusted phenytoin concentrations provided superior classification of patients than total phenytoin measurements, particularly at low albumin concentrations. Albumin plasma concentrations up to 7 days prior to total phenytoin measurements can be used for adjusted phenytoin concentrations. CONCLUSIONS: The results suggest that a measured free phenytoin should be obtained where possible to guide phenytoin dosing. If this is not feasible, then an adjusted phenytoin can supplement a total phenytoin concentration, particularly for patients with low plasma albumin.

Project description:BackgroundComputerized clinical decision support systems (CDSSs) are a promising knowledge translation tool, but often fail to meaningfully influence the outcomes they target. Low CDSS provider uptake is a potential contributor to this problem but has not been systematically studied. The objective of this systematic review and meta-regression was to determine reported CDSS uptake and identify which CDSS features may influence uptake.MethodsMedline, Embase, CINAHL, and the Cochrane Database of Controlled Trials were searched from January 2000 to August 2020. Randomized, non-randomized, and quasi-experimental trials reporting CDSS uptake in any patient population or setting were included. The main outcome extracted was CDSS uptake, reported as a raw proportion, and representing the number of times the CDSS was used or accessed over the total number of times it could have been interacted with. We also extracted context, content, system, and implementation features that might influence uptake, for each CDSS. Overall weighted uptake was calculated using random-effects meta-analysis and determinants of uptake were investigated using multivariable meta-regression.ResultsAmong 7995 citations screened, 55 studies involving 373,608 patients and 3607 providers met full inclusion criteria. Meta-analysis revealed that overall CDSS uptake was 34.2% (95% CI 23.2 to 47.1%). Uptake was only reported in 12.4% of studies that otherwise met inclusion criteria. Multivariable meta-regression revealed the following factors significantly associated with uptake: (1) formally evaluating the availability and quality of the patient data needed to inform CDSS advice; and (2) identifying and addressing other barriers to the behaviour change targeted by the CDSS.Conclusions and relevanceSystem uptake was seldom reported in CDSS trials. When reported, uptake was low. This represents a major and potentially modifiable barrier to overall CDSS effectiveness. We found that features relating to CDSS context and implementation strategy best predicted uptake. Future studies should measure the impact of addressing these features as part of the CDSS implementation strategy. Uptake reporting must also become standard in future studies reporting CDSS intervention effects.RegistrationPre-registered on PROSPERO, CRD42018092337.

Project description:BACKGROUND:Computerized decision support systems (CDSSs) are software programs that support the decision making of practitioners and other staff. Other reviews have analyzed the relationship between CDSSs, practitioner performance, and patient outcomes. These reviews reported positive practitioner performance in over half the articles analyzed, but very little information was found for patient outcomes. OBJECTIVE:The purpose of this review was to analyze the relationship between CDSSs, practitioner performance, and patient medical outcomes. PubMed, CINAHL, Embase, Web of Science, and Cochrane databases were queried. METHODS:Articles were chosen based on year published (last 10 years), high quality, peer-reviewed sources, and discussion of the relationship between the use of CDSS as an intervention and links to practitioner performance or patient outcomes. Reviewers used an Excel spreadsheet (Microsoft Corporation) to collect information on the relationship between CDSSs and practitioner performance or patient outcomes. Reviewers also collected observations of participants, intervention, comparison with control group, outcomes, and study design (PICOS) along with those showing implicit bias. Articles were analyzed by multiple reviewers following the Kruse protocol for systematic reviews. Data were organized into multiple tables for analysis and reporting. RESULTS:Themes were identified for both practitioner performance (n=38) and medical outcomes (n=36). A total of 66% (25/38) of articles had occurrences of positive practitioner performance, 13% (5/38) found no difference in practitioner performance, and 21% (8/38) did not report or discuss practitioner performance. Zero articles reported negative practitioner performance. A total of 61% (22/36) of articles had occurrences of positive patient medical outcomes, 8% (3/36) found no statistically significant difference in medical outcomes between intervention and control groups, and 31% (11/36) did not report or discuss medical outcomes. Zero articles found negative patient medical outcomes attributed to using CDSSs. CONCLUSIONS:Results of this review are commensurate with previous reviews with similar objectives, but unlike these reviews we found a high level of reporting of positive effects on patient medical outcomes.

Dataset Information

Computerized clinical decision support systems for therapeutic drug monitoring and dosing: a decision-maker-researcher partnership systematic review.

Publications

Computerized clinical decision support systems for therapeutic drug monitoring and dosing: a decision-maker-researcher partnership systematic review.

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