Abstract Objectives The current format of summary of findings (SoFs) tables for presenting effect estimates and associated quality of evidence improve understanding and assist users finding key ...information in systematic reviews. Users of SoF tables have demanded alternative formats to express findings from systematic reviews. Study Design and Setting We conducted a randomized controlled trial among systematic review users to compare the relative merits of a new format with the current formats of SoF tables regarding understanding, accessibility of information, satisfaction, and preference. Our primary goal was to show that the new format is not inferior to the current format. Results Of 390 potentially eligible subjects, 290 were randomized. Of seven items testing understanding, three showed similar results, two showed small differences favoring the new format, and two (understanding risk difference and quality of the evidence associated with a treatment effect) showed large differences favoring the new format 63% (95% confidence interval {CI}: 55, 71) and 62% (95% CI: 52, 71) more correct answers, respectively. Respondents rated information in the alternative format as more accessible overall and preferred the new format over the current format. Conclusions While providing at least similar levels of understanding for some items and increased understanding for others, users prefer the new format of SoF tables.
Background
Hospitalized medical patients are at risk for venous thromboembolism (VTE). Universal application of pharmacological thromboprophylaxis has the potential to place a large number of ...patients at increased bleeding risk. In this study, we aimed to externally validate the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk assessment model in a hospitalized general medical population.
Methods and Results
We identified medical discharges that met the IMPROVE protocol. Cases were defined as hospital‐acquired VTE and confirmed by diagnostic study within 90 days of index hospitalization; matched controls were also identified. Risk factors for VTE were based on the IMPROVE risk assessment model (aged >60 years, prior VTE, intensive care unit or coronary care unit stay, lower limb paralysis, immobility, known thrombophilia, and cancer) and were measured and assessed. A total of 19 217 patients met the inclusion criteria. The overall VTE event rate was 0.7%. The IMPROVE risk assessment model identified 2 groups of the cohort by VTE incidence rate: The low‐risk group had a VTE event rate of 0.42 (95% CI 0.31 to 0.53), corresponding to a score of 0 to 2, and the at‐risk group had a VTE event rate of 1.29 (95% CI 1.01 to 1.57), corresponding to a score of ≥3. Low‐risk status for VTE encompassed 68% of the patient cohort. The area under the receiver operating characteristic curve was 0.702, which was in line with the derivation cohort findings.
Conclusions
The IMPROVE VTE risk assessment model validation cohort revealed good discrimination and calibration for both the overall VTE risk model and the identification of low‐risk and at‐risk medical patient groups, using a risk score of ≥3. More than two thirds of the entire cohort had a score ≤2.
OBJECTIVE
We employed an agile, user-centered approach to the design of a clinical decision support tool in our prior integrated clinical prediction rule study, which achieved high adoption rates. To ...understand if applying this user-centered process to adapt clinical decision support tools is effective in improving the use of clinical prediction rules, we examined utilization rates of a clinical decision support tool adapted from the original integrated clinical prediction rule study tool to determine if applying this user-centered process to design yields enhanced utilization rates similar to the integrated clinical prediction rule study.
MATERIALS & METHODS: We conducted pre-deployment usability testing and semi-structured group interviews at 6 months post-deployment with 75 providers at 14 intervention clinics across the two sites to collect user feedback. Qualitative data analysis is bifurcated into immediate and delayed stages; we reported on immediate-stage findings from real-time field notes used to generate a set of rapid, pragmatic recommendations for iterative refinement. Monthly utilization rates were calculated and examined over 12 months.
RESULTS
We hypothesized a well-validated, user-centered clinical decision support tool would lead to relatively high adoption rates. Then 6 months post-deployment, integrated clinical prediction rule study tool utilization rates were substantially lower than anticipated based on the original integrated clinical prediction rule study trial (68%) at 17% (Health System A) and 5% (Health System B). User feedback at 6 months resulted in recommendations for tool refinement, which were incorporated when possible into tool design; however, utilization rates at 12 months post-deployment remained low at 14% and 4% respectively.
DISCUSSION
Although valuable, findings demonstrate the limitations of a user-centered approach given the complexity of clinical decision support.
CONCLUSION
Strategies for addressing persistent external factors impacting clinical decision support adoption should be considered in addition to the user-centered design and implementation of clinical decision support.
BackgroundEffective implementation of technologies into clinical workflow is hampered by lack of integration into daily activities. Normalisation process theory (NPT) can be used to describe the ...kinds of ‘work’ necessary to implement and embed complex new practices. We determined the suitability of NPT to assess the facilitators, barriers and ‘work’ of implementation of two clinical decision support (CDS) tools across diverse care settings.MethodsWe conducted baseline and 6-month follow-up quantitative surveys of clinic leadership at two academic institutions’ primary care clinics randomised to the intervention arm of a larger study. The survey was adapted from the NPT toolkit, analysing four implementation domains: sense-making, participation, action, monitoring. Domains were summarised among completed responses (n=60) and examined by role, institution, and time.ResultsThe median score for each NPT domain was the same across roles and institutions at baseline, and decreased at 6 months. At 6 months, clinic managers’ participation domain (p=0.003), and all domains for medical directors (p<0.003) declined. At 6 months, the action domain decreased among Utah respondents (p=0.03), and all domains decreased among Wisconsin respondents (p≤0.008).ConclusionsThis study employed NPT to longitudinally assess the implementation barriers of new CDS. The consistency of results across participant roles suggests similarities in the work each role took on during implementation. The decline in engagement over time suggests the need for more frequent contact to maintain momentum. Using NPT to evaluate this implementation provides insight into domains which can be addressed with participants to improve success of new electronic health record technologies.Trial registration numberNCT02534987.
Systematic reviews represent one of the most important tools for knowledge translation but users often struggle with understanding and interpreting their results. GRADE Summary-of-Findings tables ...have been developed to display results of systematic reviews in a concise and transparent manner. The current format of the Summary-of-Findings tables for presenting risks and quality of evidence improves understanding and assists users with finding key information from the systematic review. However, it has been suggested that additional methods to present risks and display results in the Summary-of-Findings tables are needed.
We will conduct a non-inferiority parallel-armed randomized controlled trial to determine whether an alternative format to present risks and display Summary-of-Findings tables is not inferior compared to the current standard format. We will measure participant understanding, accessibility of the information, satisfaction, and preference for both formats. We will invite systematic review users to participate (that is clinicians, guideline developers, and researchers). The data collection process will be undertaken using the online 'Survey Monkey' system. For the primary outcome understanding, non-inferiority of the alternative format (Table A) to the current standard format (Table C) of Summary-of-Findings tables will be claimed if the upper limit of a 1-sided 95% confidence interval (for the difference of proportion of participants answering correctly a given question) excluded a difference in favor of the current format of more than 10%.
This study represents an effort to provide systematic reviewers with additional options to display review results using Summary-of-Findings tables. In this way, review authors will have a variety of methods to present risks and more flexibility to choose the most appropriate table features to display (that is optional columns, risks expressions, complementary methods to display continuous outcomes, and so on).
NCT02022631 (21 December 2013).
•“Think Aloud” and “Near Live” usability testing generated unique and generalizable insights.•Feedback during “Think Aloud” testing primarily helped to improve the tools’ ease of use.•“Near Live” ...testing was helpful for eliciting key barriers to provider workflow and adoption.•During “Near Live” testing participants were more critical of the tools’ usefulness.•Usability testing helps decision support reach its potential to improve health outcomes.
Low provider adoption continues to be a significant barrier to realizing the potential of clinical decision support. “Think Aloud” and “Near Live” usability testing were conducted on two clinical decision support tools. Each was composed of an alert, a clinical prediction rule which estimated risk of either group A Streptococcus pharyngitis or pneumonia and an automatic order set based on risk. The objective of this study was to further understanding of the facilitators of usability and to evaluate the types of additional information gained from proceeding to “Near Live” testing after completing “Think Aloud”.
This was a qualitative observational study conducted at a large academic health care system with 12 primary care providers. During “Think Aloud” testing, participants were provided with written clinical scenarios and asked to verbalize their thought process while interacting with the tool. During “Near Live” testing participants interacted with a mock patient. Morae usability software was used to record full screen capture and audio during every session. Participant comments were placed into coding categories and analyzed for generalizable themes. Themes were compared across usability methods.
“Think Aloud” and “Near Live” usability testing generated similar themes under the coding categories visibility, workflow, content, understand-ability and navigation. However, they generated significantly different themes under the coding categories usability, practical usefulness and medical usefulness. During both types of testing participants found the tool easier to use when important text was distinct in its appearance, alerts were passive and appropriately timed, content was up to date, language was clear and simple, and each component of the tool included obvious indicators of next steps. Participant comments reflected higher expectations for usability and usefulness during “Near Live” testing. For example, visit aids, such as automatically generated order sets, were felt to be less useful during “Near-Live” testing because they would not be all inclusive for the visit.
These complementary types of usability testing generated unique and generalizable insights. Feedback during “Think Aloud” testing primarily helped to improve the tools’ ease of use. The additional feedback from “Near Live” testing, which mimics a real clinical encounter, was helpful for eliciting key barriers and facilitators to provider workflow and adoption.
Successful clinical decision support (CDS) tools can help use evidence-based medicine to effectively improve patient outcomes. However, the impact of these tools has been limited by low provider ...adoption due to overtriggering, leading to alert fatigue. We developed a tracking mechanism for monitoring trigger (percent of total visits for which the tool triggers) and adoption (percent of completed tools) rates of a complex CDS tool based on the Wells criteria for pulmonary embolism (PE).
We aimed to monitor and evaluate the adoption and trigger rates of the tool and assess whether ongoing tool modifications would improve adoption rates.
As part of a larger clinical trial, a CDS tool was developed using the Wells criteria to calculate pretest probability for PE at 2 tertiary centers' emergency departments (EDs). The tool had multiple triggers: any order for D-dimer, computed tomography (CT) of the chest with intravenous contrast, CT pulmonary angiography (CTPA), ventilation-perfusion scan, or lower extremity Doppler ultrasound. A tracking dashboard was developed using Tableau to monitor real-time trigger and adoption rates. Based on initial low provider adoption rates of the tool, we conducted small focus groups with key ED providers to elicit barriers to tool use. We identified overtriggering of the tool for non-PE-related evaluations and inability to order CT testing for intermediate-risk patients. Thus, the tool was modified to allow CT testing for the intermediate-risk group and not to trigger for CT chest with intravenous contrast orders. A dialogue box, "Are you considering PE for this patient?" was added before the tool triggered to account for CTPAs ordered for aortic dissection evaluation.
In the ED of tertiary center 1, 95,295 patients visited during the academic year. The tool triggered for an average of 509 patients per month (average trigger rate 2036/30,234, 6.73%) before the modifications, reducing to 423 patients per month (average trigger rate 1629/31,361, 5.22%). In the ED of tertiary center 2, 88,956 patients visited during the academic year, with the tool triggering for about 473 patients per month (average trigger rate 1892/29,706, 6.37%) before the modifications and for about 400 per month (average trigger rate 1534/30,006, 5.12%) afterward. The modifications resulted in a significant 4.5- and 3-fold increase in provider adoption rates in tertiary centers 1 and 2, respectively. The modifications increased the average monthly adoption rate from 23.20/360 (6.5%) tools to 81.60/280.20 (29.3%) tools and 46.60/318.80 (14.7%) tools to 111.20/263.40 (42.6%) tools in centers 1 and 2, respectively.
Close postimplementation monitoring of CDS tools may help improve provider adoption. Adaptive modifications based on user feedback may increase targeted CDS with lower trigger rates, reducing alert fatigue and increasing provider adoption. Iterative improvements and a postimplementation monitoring dashboard can significantly improve adoption rates.
IMPORTANCE There is consensus that incorporating clinical decision support into electronic health records will improve quality of care, contain costs, and reduce overtreatment, but this potential has ...yet to be demonstrated in clinical trials. OBJECTIVE To assess the influence of a customized evidence-based clinical decision support tool on the management of respiratory tract infections and on the effectiveness of integrating evidence at the point of care. DESIGN, SETTING, AND PARTICIPANTS In a randomized clinical trial, we implemented 2 well-validated integrated clinical prediction rules, namely, the Walsh rule for streptococcal pharyngitis and the Heckerling rule for pneumonia. INTERVENTIONS AND MAIN OUTCOMES AND MEASURES The intervention group had access to the integrated clinical prediction rule tool and chose whether to complete risk score calculators, order medications, and generate progress notes to assist with complex decision making at the point of care. RESULTS The intervention group completed the integrated clinical prediction rule tool in 57.5% of visits. Providers in the intervention group were significantly less likely to order antibiotics than the control group (age-adjusted relative risk, 0.74; 95% CI, 0.60-0.92). The absolute risk of the intervention was 9.2%, and the number needed to treat was 10.8. The intervention group was significantly less likely to order rapid streptococcal tests compared with the control group (relative risk, 0.75; 95% CI, 0.58-0.97; P = .03). CONCLUSIONS AND RELEVANCE The integrated clinical prediction rule process for integrating complex evidence-based clinical decision report tools is of relevant importance for national initiatives, such as Meaningful Use. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01386047
Summary
The IMPROVE Bleed Risk Assessment Model (RAM) remains the only bleed RAM in hospitalised medical patients using 11 clinical and laboratory factors. The aim of our study was to externally ...validate the IMPROVE Bleed RAM. A retrospective chart review was conducted between October 1, 2012 and July 31, 2014. We applied the point scoring system to compute risk scores for each patient in the validation sample. We then dichotomised the patients into those with a score <7 (low risk) vs ≥ 7 (high risk), as outlined in the original study, and compared the rates of any bleed, non-major bleed, and major bleed. Among the 12,082 subjects, there was an overall 2.6 % rate of any bleed within 14 days of admission. There was a 2.12 % rate of any bleed in those patients with a score of < 7 and a 4.68 % rate in those with a score ≥ 7 Odds Ratio (OR) 2.3 (95 % CI=1.8–2.9), p<0.0001. MB rates were 1.5 % in the patients with a score of < 7 and 3.2 % in the patients with a score of ≥ 7, OR 2.2 (95 % CI=1.6–2.9), p<0.0001. The ROC curve was 0.63 for the validation sample. This study represents the largest externally validated Bleed RAM in a hospitalised medically ill patient population. A cut-off point score of 7 or above was able to identify a high-risk patient group for MB and any bleed. The IMPROVE Bleed RAM has the potential to allow for more tailored approaches to thromboprophylaxis in medically ill hospitalised patients.
Supplementary Material to this article is available online at www.thrombosis-online.com.
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