Harriette G.C. Van Spall

Features of effective computerised clinical decision support systems: meta-regression of 162 randomised trials

Objectives To identify factors that differentiate between effective and ineffective computerised clinical decision support systems in terms of improvements in the process of care or in patient outcomes. Design Meta-regression analysis of randomised controlled trials. Data sources A database of features and effects of these support systems derived from 162 randomised controlled trials identified in a recent systematic review. Trialists were contacted to confirm the accuracy of data and to help prioritise features for testing. Main outcome measures “Effective” systems were defined as those systems that improved primary (or 50% of secondary) reported outcomes of process of care or patient health. Simple and multiple logistic regression models were used to test characteristics for association with system effectiveness with several sensitivity analyses. Results Systems that presented advice in electronic charting or order entry system interfaces were less likely to be effective (odds ratio 0.37, 95% confidence interval 0.17 to 0.80). Systems more likely to succeed provided advice for patients in addition to practitioners (2.77, 1.07 to 7.17), required practitioners to supply a reason for over-riding advice (11.23, 1.98 to 63.72), or were evaluated by their developers (4.35, 1.66 to 11.44). These findings were robust across different statistical methods, in internal validation, and after adjustment for other potentially important factors. Conclusions We identified several factors that could partially explain why some systems succeed and others fail. Presenting decision support within electronic charting or order entry systems are associated with failure compared with other ways of delivering advice. Odds of success were greater for systems that required practitioners to provide reasons when over-riding advice than for systems that did not. Odds of success were also better for systems that provided advice concurrently to patients and practitioners. Finally, most systems were evaluated by their own developers and such evaluations were more likely to show benefit than those conducted by a third party.

Variation in Warfarin Dose Adjustment Practice Is Responsible for Differences in the Quality of Anticoagulation Control Between Centers and Countries An Analysis of Patients Receiving Warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Trial

Background— The outcome of atrial fibrillation patients on warfarin partially depends on maintaining adequate time in therapeutic International Normalized Ratio range (TTR). Large differences in TTR have been reported between centers and countries. The association between warfarin dosing practice, TTR, and clinical outcomes was evaluated in Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial patients receiving warfarin. Methods and Results— RE-LY provided an algorithm for warfarin dosing, recommending no change for in-range, and 10% to 15% weekly dose changes for out-of-range International Normalized Ratio values. We determined whether dose adjustments were consistent with algorithm recommendations but could not verify whether providers used the algorithm. Using multilevel regression models to adjust for patient, center, and country characteristics, we assessed whether algorithm-consistent warfarin dosing could predict patient TTR and the composite outcome of stroke, systemic embolism, or major hemorrhage. We included 6022 nonvalvular atrial fibrillation patients from 912 centers in 44 countries. We found a strong association between the proportion of algorithm-consistent warfarin doses and mean country TTR ( R 2=0.65). The degree of algorithm-consistency accounted for 87% of the between-center and 55% of the between-country TTR variation. Each 10% increase in center algorithm-consistent dosing independently predicted a 6.12% increase in TTR (95% confidence interval, 5.65–6.59) and an 8% decrease in rate of the composite clinical outcome (hazard ratio, 0.92; 95% confidence interval, 0.85–1.00). Conclusions— Adherence, intentional or not, to a simple warfarin dosing algorithm predicts improved TTR and accounts for considerable TTR variation between centers and countries. Systems facilitating algorithm-based warfarin dosing could optimize anticoagulation quality and improve clinical outcomes in atrial fibrillation on a global scale. Clinical Trial Registration— URL: . Unique identifier: [NCT00262600][1]. # Clinical Perspective {#article-title-22} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00262600&atom=%2Fcirculationaha%2F126%2F19%2F2309.atomBackground— The outcome of atrial fibrillation patients on warfarin partially depends on maintaining adequate time in therapeutic International Normalized Ratio range (TTR). Large differences in TTR have been reported between centers and countries. The association between warfarin dosing practice, TTR, and clinical outcomes was evaluated in Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial patients receiving warfarin. Methods and Results— RE-LY provided an algorithm for warfarin dosing, recommending no change for in-range, and 10% to 15% weekly dose changes for out-of-range International Normalized Ratio values. We determined whether dose adjustments were consistent with algorithm recommendations but could not verify whether providers used the algorithm. Using multilevel regression models to adjust for patient, center, and country characteristics, we assessed whether algorithm-consistent warfarin dosing could predict patient TTR and the composite outcome of stroke, systemic embolism, or major hemorrhage. We included 6022 nonvalvular atrial fibrillation patients from 912 centers in 44 countries. We found a strong association between the proportion of algorithm-consistent warfarin doses and mean country TTR (R2=0.65). The degree of algorithm-consistency accounted for 87% of the between-center and 55% of the between-country TTR variation. Each 10% increase in center algorithm-consistent dosing independently predicted a 6.12% increase in TTR (95% confidence interval, 5.65–6.59) and an 8% decrease in rate of the composite clinical outcome (hazard ratio, 0.92; 95% confidence interval, 0.85–1.00). Conclusions— Adherence, intentional or not, to a simple warfarin dosing algorithm predicts improved TTR and accounts for considerable TTR variation between centers and countries. Systems facilitating algorithm-based warfarin dosing could optimize anticoagulation quality and improve clinical outcomes in atrial fibrillation on a global scale. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00262600.

Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial

Background: A hip fracture causes bleeding, pain and immobility, and initiates inflammatory, hypercoagulable, catabolic and stress states. Accelerated surgery may improve outcomes by reducing the duration of these states and immobility. We undertook a pilot trial to determine the feasibility of a trial comparing accelerated care (i.e., rapid medical clearance and surgery) and standard care among patients with a hip fracture. Methods: Patients aged 45 years or older who, during weekday, daytime working hours, received a diagnosis of a hip fracture requiring surgery were randomly assigned to receive accelerated or standard care. Our feasibility outcomes included the proportion of eligible patients randomly assigned, completeness of follow-up and timelines of accelerated surgery. The main clinical outcome, assessed by data collectors and adjudicators who were unaware of study group allocations, was a major perioperative complication (i.e., a composite of death, preoperative myocardial infarction, myocardial injury after noncardiac surgery, pulmonary embolism, pneumonia, stroke, and life-threatening or major bleeding) within 30 days of randomization. Results: Of patients eligible for inclusion, 80% consented and were randomly assigned to groups (30 to accelerated care and 30 to standard care) at 2 centres in Canada and 1 centre in India. All patients completed 30-day follow-up. The median time from diagnosis to surgery was 6.0 hours in the accelerated care group and 24.2 hours in the standard care group (p < 0.001). A major perioperative complication occurred in 9 (30%) of the patients in the accelerated care group and 14 (47%) of the patients in the standard care group (hazard ratio 0.60, 95% confidence interval 0.26–1.39). Interpretation: These results show the feasibility of a trial comparing accelerated and standard care among patients with hip fracture and support a definitive trial. Trial registration: ClinicalTrials.gov, no. NCT01344343.

Not a broken heart

In January, 2006, a 43-year-old woman presented to the emergency department at our hospital with a 1-h history of chest tightness, palpitations, light-headedness, and sweating. The patient stated that she had experienced her fi rst such episode 4 months previously; since then, the episodes, which were unrelated to exertion or emotional stressors, had become ever more frequent and severe. No cardiac risk factors were identifi ed. Aside from a blood pressure of 95/60 mm Hg, the physical examination was unremarkable. Serial electrocardiography (ECG) showed sinus rhythm, deep global T-wave inversions, and a prolonged corrected QT interval (480 ms). The serum concentration of troponin T was mildly elevated. The patient was given aspirin, heparin, and atorvastatin for presumed acute coronary syndrome. Coronary angiography showed no abnormality. Ventriculography and two-dimensional echocardiography (2DE) showed akinesis of the middle and distal segments of the left ventricle, and basal hyperkinesis, causing apical ballooning (fi gure). 2DE showed recovery of leftventricular function within 3 days; the ECG abnormalities resolved within 4 weeks. We diagnosed transient leftventricular apical ballooning (LVAB) syndrome. Given the absence of evident precipitants, we measured the 24-h urinary excretion of epinephrine, norepinephrine, and metanephrines, which was 461 nmoles, 1133 nmoles, and 75·7 μmoles respectively (highest normal values 60 nmoles, 600 nmoles, and 5·5 μmoles, respectively). These fi ndings were in keeping with a phaeochromocytoma: the patient was prescribed doxazosin. MRI of the abdomen showed no adrenal masses, but did reveal a large necrotic para-aortic mass that extended from the vertebral bodies to the anterior abdominal wall. Radiolabelled metaiodobenzylguanidine was taken up by the mass. We diagnosed a paraganglioma. The mass was resected; histopathological analysis confi rmed the diagnosis. The patient’s 24-h urinary excretion of epinephrine, norepinephrine, and metanephrines returned to normal. Transient LVAB syndrome is characterised by systolic dysfunction, with reduced movement of the apex and middle of the left ventricle, and increased movement of the base. It is caused by acute psychological or physical stress, and occurs more commonly in women than in men. Presenting features typically include chest pain and ECG abnormalities; heart failure can also occur. ECG abnormalities that can sometimes distinguish the syndrome from anterior myocardial infarction include more prominent ST-segment elevation in leads V4–6 than in leads V1–3, absent reciprocal changes in the inferior leads, deep precordial or global T-wave inversions, and striking prolongation of the QT interval. When caused by psychological stress, transient LVAB syndrome is known as Takotsubo cardiomyopathy, a name derived from the round-bottomed, narrow-necked Japanese octopus trap (“tako-tsubo”) that the left ventricle resembles in systole. Raised plasma catecholamine concentrations have recently been reported in a cohort of patients with transient LVAB syndrome. The specifi c mechanisms by which catecholamine excess causes transient LVAB are unknown, but could include epicardial or microvascular spasm, or direct myocardial injury. The cardiac apex may be particularly sensitive to adrenergic stimulation. In our patient, catecholamine secretion from a paraganglioma caused cardiac changes indistinguish able from Takotsubo cardiomyopathy, supporting the hypothesis that the eff ects of psychological stress on the heart are mediated by catecholamines.

Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta‐analysis

To compare the effectiveness of transitional care services in decreasing all‐cause death and all‐cause readmissions following hospitalization for heart failure (HF).

Prediction of emergent heart failure death by semi-quantitative triage risk stratification.

Objectives Generic triage risk assessments are widely used in the emergency department (ED), but have not been validated for prediction of short-term risk among patients with acute heart failure (HF). Our objective was to evaluate the Canadian Triage Acuity Scale (CTAS) for prediction of early death among HF patients. Methods We included patients presenting with HF to an ED in Ontario from Apr 2003 to Mar 2007. We used the National Ambulatory Care Reporting System and vital statistics databases to examine care and outcomes. Results Among 68,380 patients (76±12 years, 49.4% men), early mortality was stratified with death rates of 9.9%, 1.9%, 0.9%, and 0.5% at 1-day, and 17.2%, 5.9%, 3.8%, and 2.5% at 7-days, for CTAS 1, 2, 3, and 4–5, respectively. Compared to lower acuity (CTAS 4–5) patients, adjusted odds ratios (aOR) for 1-day death were 1.32 (95%CI; 0.93–1.88; p = 0.12) for CTAS 3, 2.41 (95%CI; 1.71–3.40; p<0.001) for CTAS 2, and highest for CTAS 1: 9.06 (95%CI; 6.28–13.06; p<0.001). Predictors of triage-critical (CTAS 1) status included oxygen saturation <90% (aOR 5.92, 95%CI; 3.09–11.81; p<0.001), respiratory rate >24 breaths/minute (aOR 1.96, 95%CI; 1.05–3.67; p = 0.034), and arrival by paramedic (aOR 3.52, 95%CI; 1.70–8.02; p = 0.001). While age/sex-adjusted CTAS score provided good discrimination for ED (c-statistic = 0.817) and 1-day (c-statistic = 0.724) death, mortality prediction was improved further after accounting for cardiac and non-cardiac co-morbidities (c-statistics 0.882 and 0.810, respectively; both p<0.001). Conclusions A semi-quantitative triage acuity scale assigned at ED presentation and based largely on respiratory factors predicted emergent death among HF patients.

Strain, Strain Rate, and the Force Frequency Relationship in Patients with and without Heart Failure

BACKGROUND The aim of this study was to examine the effect of heart rate (HR) on indices of deformation in adults with and without heart failure (HF) who underwent simultaneous high-fidelity catheterization of the left ventricle to describe the force-frequency relationship. METHODS Right atrial pacing to control HR and high-fidelity recordings of left ventricular (LV) pressure were used to inscribe the force-frequency relationship. Simultaneous two-dimensional echocardiographic imaging was acquired for speckle-tracking analysis. RESULTS Thirteen patients with normal LV function and 12 with systolic HF (LV ejection fraction, 31 ± 13%) were studied. Patients with HF had depressed isovolumic contractility and impaired longitudinal strain and strain rate. HR-dependent increases in LV+dP/dt(max), the force-frequency relationship, was demonstrated in both groups (normal LV function, baseline to 100 beats/min: 1,335 ± 296 to 1,564 ± 320 mm Hg/sec, P < .0001; HF, baseline to 100 beats/min: 970 ± 207 to 1,083 ± 233 mm Hg/sec, P < .01). Longitudinal strain decreased significantly (normal LV function, baseline to 100 beats/min: 18.0 ± 3.5% to 10.8 ± 6.0%, P < .001; HF: 9.4 ± 4.1% to 7.5 ± 3.4%, P < .01). The decrease in longitudinal strain was related to a decrease in LV end-diastolic dimensions. Strain rate did not change with right atrial pacing. CONCLUSIONS Despite the inotropic effect of increasing HR, longitudinal strain decreases in parallel with stroke volume as load-dependent indices of ejection. Strain rate did not reflect the modest HR-related changes in contractility; on the other hand, the use of strain rate for quantitative stress imaging is also less likely to be confounded by chronotropic responses.

Efficacy of Hospital at Home in Patients with Heart Failure: A Systematic Review and Meta-Analysis.

Background Heart failure (HF) is the commonest cause of hospitalization in older adults. Compared to routine hospitalization (RH), hospital at home (HaH)—substitutive hospital-level care in the patient’s home—improves outcomes and reduces costs in patients with general medical conditions. The efficacy of HaH in HF is unknown. Methods and Results We searched MEDLINE, Embase, CINAHL, and CENTRAL, for publications from January 1990 to October 2014. We included prospective studies comparing substitutive models of hospitalization to RH in HF. At least 2 reviewers independently selected studies, abstracted data, and assessed quality. We meta-analyzed results from 3 RCTs (n = 203) and narratively synthesized results from 3 observational studies (n = 329). Study quality was modest. In RCTs, HaH increased time to first readmission (mean difference (MD) 14.13 days [95% CI 10.36 to 17.91]), and improved health-related quality of life (HrQOL) at both, 6 months (standardized MD (SMD) -0.31 [-0.45 to -0.18]) and 12 months (SMD -0.17 [-0.31 to -0.02]). In RCTs, HaH demonstrated a trend to decreased readmissions (risk ratio (RR) 0.68 [0.42 to 1.09]), and had no effect on all-cause mortality (RR 0.94 [0.67 to 1.32]). HaH decreased costs of index hospitalization in all RCTs. HaH reduced readmissions and emergency department visits per patient in all 3 observational studies. Conclusions In the context of a limited number of modest-quality studies, HaH appears to increase time to readmission, reduce index costs, and improve HrQOL among patients requiring hospital-level care for HF. Larger RCTs are necessary to assess the effect of HaH on readmissions, mortality, and long-term costs.

Effectiveness of implementation strategies in improving physician adherence to guideline recommendations in heart failure: a systematic review protocol

Introduction The uptake of Clinical Practice Guideline (CPG) recommendations that improve outcomes in heart failure (HF) remains suboptimal. We will conduct a systematic review to identify implementation strategies that improve physician adherence to class I recommendations, those with clear evidence that benefits outweigh the risks. We will use American, Canadian and European HF guidelines as our reference. Methods and analysis We will conduct a literature search in the databases of MEDLINE, EMBASE, HEALTHSTAR, CINAHL, Cochrane Library, Campbell Collaboration, Joanna Briggs Institute Evidence Based Practice, Centre for Reviews and Dissemination and Evidence Based Practice Centres. We will include prospective studies evaluating implementation interventions aimed at improving uptake of class I CPG recommendations in HF. We will extract data in duplicate. We will classify interventions according to their level of application (ie, provider, organisation, systems level) and common underlying characteristics (eg, education, decision-support, financial incentives) using the Cochrane Effective Practice and Organisation of Care Taxonomy. We will assess the impact of the intervention on adherence to the CPGs. Outcomes will include proportion of eligible patients who were: prescribed a CPG-recommended pharmacological treatment; referred for device consideration; provided self-care education at discharge; and provided left ventricular function assessment. We will include clinical outcomes such as hospitalisations, readmissions and mortality, if data is available. We will identify the common elements of successful and failing interventions, and examine the context in which they were applied, using the Process Redesign contextual framework. We will synthesise the results narratively and, if appropriate, will pool results for meta-analysis. Discussion and dissemination In this review, we will assess the impact of implementation strategies and contextual factors on physician adherence to HF CPGs. We will explore why some interventions may succeed in one setting and fail in another. We will disseminate our findings through briefing reports, publications and presentations. Trial registration number CRD42015017155.

Near-misses are an opportunity to improve patient safety: Adapting strategies of high reliability organizations to healthcare

PURPOSE OF REVIEW Near-miss investigations in high reliability organizations (HROs) aim to mitigate risk and improve system safety. Healthcare settings have a higher rate of near-misses and subsequent adverse events than most high-risk industries, but near-misses are not systematically reported or analyzed. In this review, we will describe the strategies for near-miss analysis that have facilitated a culture of safety and continuous quality improvement in HROs. RECENT FINDINGS Near-miss analysis is routine and systematic in HROs such as aviation. Strategies implemented in aviation include the Commercial Aviation Safety Team, which undertakes systematic analyses of near-misses, so that findings can be incorporated into Standard Operating Procedures (SOPs). Other strategies resulting from incident analyses include Crew Resource Management (CRM) for enhanced communication, situational awareness training, adoption of checklists during operations, and built-in redundancy within systems. SUMMARY Health care organizations should consider near-misses as opportunities for quality improvement. The systematic reporting and analysis of near-misses, commonplace in HROs, can be adapted to health care settings to prevent adverse events and improve clinical outcomes.