Missed Acute Coronary Syndrome During Telephone Triage at Out-of-Hours Primary Care: Lessons From A Case-Control Study.

OBJECTIVES: Serious adverse events at out-of-hours services in primary care (OHS-PC) are rare, and the most often concern is missed acute coronary syndrome (ACS). Previous studies on serious adverse events mainly concern root cause analyses, which highlighted errors in the telephone triage process but are hampered by hindsight bias. This study compared the recorded triage calls of patients with chest discomfort contacting the OHS-PC in whom an ACS was missed (cases), with triage calls involving matched controls with chest discomfort but without a missed ACS (controls), with the aim to assess the predictors of missed ACS. METHODS: A case-control study with data from 2013 to 2017 of 9 OHS-PC in the Netherlands. The cases were matched 1:8 with controls based on age and sex. Clinical, patient, and call characteristics were univariably assessed, and general practitioner experts evaluated the triage while blinded to the final diagnosis or the case-control status. RESULTS: Fifteen missed ACS calls and 120 matched control calls were included. Cases used less cardiovascular medication (38.5% versus 64.1%, P = 0.05) and more often experienced pain other than retrosternal chest pain (63.3% versus 24.7%, P = 0.02) compared with controls. Consultation of the supervising general practitioner (86.7% versus 49.2%, P = 0.02) occurred more often in cases than in controls. Experts rated the triage of cases more often as "poor" (33.3% versus 10.9%, P = 0.001) and "unsafe" (73.3% versus 22.5%, P < 0.001) compared with controls. CONCLUSIONS: To facilitate learning from serious adverse events in the future, these should also be bundled and carefully assessed without hindsight bias and within the context of "normal" clinical practice.

Non-dispensing pharmacist integrated in the primary care team: effect on the quality of physician's prescribing, a non-randomised comparative study.

Background Especially in elderly with polypharmacy, medication can do harm. Clinical pharmacists integrated in primary care teams might improve quality of pharmaceutical care. Objective To assess the effect of non-dispensing clinical pharmacists integrated in primary care teams on general practitioners' prescribing quality. Setting This study was conducted in 25 primary care practices in the Netherlands. Methods Non-randomised, controlled, multi-centre, complex intervention study with pre-post comparison. First, we identified potential prescribing quality indicators from the literature and assessed their feasibility, validity, acceptability, reliability and sensitivity to change. Also, an expert panel assessed the indicators' health impact. Next, using the final set of indicators, we measured the quality of prescribing in practices where non-dispensing pharmacists were integrated in the team (intervention group) compared to usual care (two control groups). Data were extracted anonymously from the healthcare records. Comparisons were made using mixed models correcting for potential confounders. Main outcome measure Quality of prescribing, measured with prescribing quality indicators. Results Of 388 eligible indicators reported in the literature we selected 8. In addition, two more indicators relevant for Dutch general practice were formulated by an expert panel. Scores on all 10 indicators improved in the intervention group after introduction of the non-dispensing pharmacist. However, when compared to control groups, prescribing quality improved solely on the indicator measuring monitoring of the renal function in patients using antihypertensive medication: relative risk of a monitored renal function in the intervention group compared to usual care: 1.03 (95% CI 1.01-1.05, p-value 0.010) and compared to usual care plus: 1.04 (1.01-1.06, p-value 0.004). Conclusion This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.This study is part of the POINT-study, which was registered at The Netherlands National Trial Register with trial registration number NTR-4389.

Value of Repeated Troponin Measurements to Improve the Safety of the HEART Score for Chest Pain Patients at the Emergency Department.

OBJECTIVE: The HEART score is a clinical decision support tool for physicians to stratify the risk of major adverse cardiac events (MACE) in patients presenting with chest pain at the emergency department. The score includes 5 elements, including troponin level. Our aim was to compare safety and efficiency of the HEART scores calculated by using the first representative troponin (ie, based on time since symptom onset) compared to the original HEART score, where calculation was based on the first available troponin measurement, irrespective of duration of symptoms. METHODS: We performed a secondary analysis on patients from the HEART-impact trial (2013-2014, the Netherlands). Two HEART scores were calculated for all patients: a HEART score with a T (troponin) element score based on the first available troponin (HEART-first) and 1 with a T element score based on the first representative troponin (ie, at least 3 hours after symptom onset; HEART-representative). We compared all patients' scores and risk categories between HEART-first and HEART-representative. Furthermore, we compared safety (proportion of patients with MACE receiving a low score) and efficiency (proportion of patients with a low score) between HEART-first and HEART-representative. RESULTS: We included 1222 patients. In 882 (72%) patients, the first troponin was representative, resulting in the same HEART-first and HEART-representative score. In the remaining 340 patients the use of HEART-representative led to a different score than HEART-first in 43 patients (3.5%). Out of the 222 patients with MACE, 11 patients (5.0%) received a low score by using HEART-first compared with 10 patients (4.5%) when using HEART-representative (P = 0.83). The number of patients with a low score was similar (P = 0.93) when using the HEART-first (464/1222; 38%) or HEART-representative score (462/1222; 38%). CONCLUSIONS: Using a representative troponin measurement changed the value of the HEART score in only 3.5% of patients and had no impact on safety and efficiency of the HEART score. These results suggest there is no need to wait for a representative troponin measurement and should encourage physicians to adhere to the original HEART score guidelines.

Decision analytic modeling was useful to assess the impact of a prediction model on health outcomes before a randomized trial.

OBJECTIVE: To demonstrate how decision analytic models (DAMs) can be used to quantify impact of using a (diagnostic or prognostic) prediction model in clinical practice and provide general guidance on how to perform such assessments. STUDY DESIGN AND SETTING: A DAM was developed to assess the impact of using the HEART score for predicting major adverse cardiac events (MACE). Impact on patient health outcomes and health care costs was assessed in scenarios by varying compliance with and informed deviation (ID) (using additional clinical knowledge) from HEART score management recommendations. Probabilistic sensitivity analysis was used to assess estimated impact robustness. RESULTS: Impact of using the HEART score on health outcomes and health care costs was influenced by an interplay of compliance with and ID from HEART score management recommendations. Compliance of 50% (with 0% ID) resulted in increased missed MACE and costs compared with usual care. Any compliance combined with at least 50% ID reduced both costs and missed MACE. Other scenarios yielded a reduction in missed MACE at higher costs. CONCLUSION: Decision analytic modeling is a useful approach to assess impact of using a prediction model in practice on health outcomes and health care costs. This approach is recommended before conducting an impact trial to improve its design and conduct.

Transitional safety incidents as reported by patients and healthcare professionals in the Netherlands: A descriptive study.

BACKGROUND: Care transitions between general practice and hospital are hazardous regarding patient safety. For developing an improvement strategy adjusted to local settings, understanding of type and potential causes of transitional safety incidents (TSIs) is needed. OBJECTIVES: To provide a broad overview of the nature of TSIs reported by patients and healthcare professionals. METHODS: We collected data (2011-2015) from three hospitals and 56 affiliated general practitioners (GPs) in two Dutch regions (one urban, one rural). We collected data from patients through a survey, interviews and incident reporting weeks, and from GPs and hospital specialists through incident reporting systems, surveys, interviews and focus group discussions. We classified reported TSIs according to type, cause and severity. RESULTS: In total, 548 TSIs were reported by 411 patients and 137 healthcare professionals; 368 of 548 TSI reports contained sufficient information for classification into aspects of the care transition process, 191 of 548 for cause, and 149 of 548 for severity. Most TSIs concerned handover correspondence from hospital to GP (26%), referral (14%) and communication/collaboration (14%). Concerning cause, reported TSIs could be attributed to organizational (48%) and human factors (43%). Twenty-four percent concerned unsafe situations, 45% near misses and 31% adverse events. Patients and healthcare professionals reported differently on referral (17% vs 9%), repeated diagnostic testing (20% vs 1%), and uncertainty about assigned responsible physician (10% vs 3%). CONCLUSION: Reported TSIs typically concerned informational discontinuity. One third caused harm to the patient. Patients report different TSIs than healthcare professionals, suggesting a different view.

Non-dispensing pharmacists' actions and solutions of drug therapy problems among elderly polypharmacy patients in primary care.

OBJECTIVE: To evaluate the process of clinical medication review for elderly patients with polypharmacy performed by non-dispensing pharmacists embedded in general practice. The aim was to identify the number and type of drug therapy problems and to assess how and to what extent drug therapy problems were actually solved. METHOD: An observational cross-sectional study, conducted in nine general practices in the Netherlands between June 2014 and June 2015. On three pre-set dates, the non-dispensing pharmacists completed an online data form about the last 10 patients who completed all stages of clinical medication review. Outcomes were the type and number of drug therapy problems, the extent to which recommendations were implemented and the percentage of drug therapy problems that were eventually solved. Interventions were divided as either preventive (aimed at following prophylactic guidelines) or corrective (aimed at active patient problems). RESULTS: In total, 1292 drug therapy problems were identified among 270 patients, with a median of 5 (interquartile range 3) drug therapy problems per patient, mainly related to overtreatment (24%) and undertreatment (21%). The non-dispensing pharmacists most frequently recommended to stop medication (32%). Overall, 83% of the proposed recommendations were implemented; 57% were preventive, and 35% were corrective interventions (8% could not be assessed). Almost two-third (64%) of the corrective interventions actually solved the drug therapy problem. CONCLUSION: Non-dispensing pharmacists integrated in general practice identified a large number of drug therapy problems and successfully implemented a proportionally high number of recommendations that solved the majority of drug therapy problems.

The transitional risk and incident questionnaire was valid and reliable for measuring transitional patient safety from the patients' perspective.

OBJECTIVE: This study describes the development and validation of the Transitional Risk and Incident Questionnaire (TRIQ), which measures transitional patient safety from the patients' perspective. METHODS: The TRIQ was developed based on literature review, tested in the target group using a think-aloud procedure, and validated by a cross-sectional study among patients receiving health care at the interface between general practice and hospital care in two regions in the Netherlands. Exploratory factor analysis was performed, and internal consistency was assessed. The relationships between the occurrence of transitional safety incidents (TSIs) as measured by the TRIQ and relational continuity and those between TSI occurrence and overall rating of transitions were assessed. RESULTS: In total, 451 questionnaires were completed for analysis. The exploratory factor analysis provided a four-factor solution: (1) personal relation with general practitioner, (2) personal relation with hospital physician, (3) information exchange, and (4) treatment consistency. Internal consistency was good (composite reliability, 0.75-0.95). An experienced TSI was related to a poorer relational continuity both with the general practitioner and hospital and with a lower overall rating of all transitions. CONCLUSIONS: The TRIQ is a valid and reliable questionnaire measuring transitional patient safety from the patients' perspective.

Validity and reliability of a medical record review method identifying transitional patient safety incidents in merged primary and secondary care patients' records.

OBJECTIVE: Inadequate information transfer during transitions in healthcare is a major patient safety issue. Aim of this study was to pilot a review of medical records to identify transitional safety incidents (TSIs) for use in a large intervention study and assess its reliability and validity. DESIGN: A retrospective medical record review study. SETTINGS AND PARTICIPANTS: Combined primary and secondary care medical records of 301 patients who had visited their general practitioner and the University Medical Center Utrecht, the Netherlands, in 2013 were randomly selected. Six trained reviewers assessed these medical records for presence of TSIs. OUTCOMES: To assess inter-rater reliability, 10% of medical records were independently reviewed twice. To assess validity, the identified TSIs were compared with a reference standard of three objectively identifiable TSIs. RESULTS: The reviewers identified TSIs in 52 (17.3%) of all transitional medical records. Variation between reviewers was high (range: 3-28 per 50 medical records). Positive agreement for finding a TSI between reviewers was 0%, negative agreement 80% and the Cohen's kappa -0.15. The reviewers identified 43 (22%) of 194 objectively identifiable TSIs. CONCLUSION: The reliability of our measurement tool for identifying TSIs in transitional medical record performed by clinicians was low. Although the TSIs that were identified by clinicians were valid, they missed 80% of them. Restructuring the record review procedure is necessary.

Measurement tools and outcome measures used in transitional patient safety; a systematic review.

BACKGROUND: Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of transitional patient safety, valid measurement tools are needed. AIM AND METHODS: To identify and appraise all measurement tools and outcomes that measure aspects of transitional patient safety, PubMed, Cinahl, Embase and Psychinfo were systematically searched. Two researchers performed the title and abstract and full-text selection. First, publications about validation of measurement tools were appraised for quality following COSMIN criteria. Second, we inventoried all measurement tools and outcome measures found in our search that assessed current transitional patient safety or the effect of interventions targeting transitional patient safety. RESULTS: The initial search yielded 8288 studies, of which 18 assessed validity of measurement tools of different aspects of transitional safety, and 191 assessed current transitional patient safety or effect of interventions. In the validated measurement tools, the overall quality of content and structural validity was acceptable; other COSMIN criteria, such as reliability, measurement error and responsiveness, were mostly poor or not reported. In our outcome inventory, the most frequently used validated outcome measure was the Care Transition Measure (n = 9). The most frequently used non-validated outcome measures were: medication discrepancies (n = 98), hospital readmissions (n = 55), adverse events (n = 34), emergency department visits (n = 33), (mental or physical) health status (n = 28), quality and timeliness of discharge summary, and patient satisfaction (n = 23). CONCLUSIONS: Although no validated measures exist that assess all aspects of transitional patient safety, we found validated measurement tools on specific aspects. Reporting of validity of transitional measurement tools was incomplete. Numerous outcome measures with unknown measurement properties are used in current studies on safety of care transitions, which makes interpretation or comparison of their results uncertain.

Validation of a questionnaire measuring transitional patient safety climate indicated differences in transitional patient safety climate between primary and secondary care.

OBJECTIVES: This study describes the development and validation of the TRAnsitional patient safety Climate Evaluation (TRACE) questionnaire, measuring transitional patient safety climate from the perspective of general practitioners and hospital physicians. Patient safety climate reflects the professionals' perception of the organizational patient safety culture. STUDY DESIGN AND SETTING: In the development of the TRACE, we adjusted existing questionnaires on patient safety culture. Exploratory factor analysis (EFA) was performed. Internal consistency and correlations between factors and a global transitional patient safety rating were calculated. RESULTS: In total, 162 questionnaires were completed (response 23%; general practice: N = 97, hospital physicians: N = 65). Analysis of all respondents did not provide an interpretable factor solution. However, the EFA on the results of hospital physicians revealed four relevant factors: (1) collaboration, (2) speaking up, (3) communication on transitional incidents and improvement measures, and (4) transitional patient safety management. The internal consistency of these factors was good for hospital respondents (0.71-0.87) and fair to acceptable for general practices' respondents (0.63-0.72). CONCLUSION: Although the TRACE questionnaire did not provide a solid factor structure in a combined sample of general practice and hospital respondents, the factors found reliable in hospital setting had acceptable reliability in general practice setting.

In-hospital prescription changes and documentation in the medical records of the primary care provider: results from a medical record review study.

BACKGROUND: An increasing number of transitions due to substitution of care of more complex patients urges insight in and improvement of transitional medication safety. While lack of documentation of prescription changes and/or lack of information exchange between settings likely cause adverse drug events, frequency of occurrence of these causes is not clear. Therefore, we aimed at determining the frequency of in-hospital patients' prescription changes that are not or incorrectly documented in their primary care provider's (PCP) medical record. METHODS: A medical record review study was performed in a database linking patients' medical records of hospital and PCP. A random sample (n = 600) was drawn from all 1399 patients who were registered at a participating primary care practice as well as the gastroenterology or cardiology department in 2013 of the University Medical Center Utrecht, the Netherlands. Outcomes were the number of in-hospital prescription changes that was not or incorrectly documented in the medical record of the PCP, and timeliness of documentation. RESULTS: Records of 390 patients included one or more primary-secondary care transitions; in total we identified 1511 transitions. During these transitions, 408 in-hospital prescription changes were made, of which 31% was not or incorrectly documented in the medical record of the PCP within the next 3 months. In case changes were documented, the median number of days between hospital visit and documentation was 3 (IQR 0­18). CONCLUSIONS: One third of in-hospital prescription changes was not or incorrectly documented in the PCP's record, which likely puts patients at risk of adverse drug events after hospital visits. Such flawed reliability of a routine care process is unacceptable and warrants improvement and close monitoring.

Secondary analysis of frequency, circumstances and consequences of calculation errors of the HEART (history, ECG, age, risk factors and troponin) score at the emergency departments of nine hospitals in the Netherlands.

OBJECTIVE: The HEART score can accurately stratify the risk of major adverse cardiac events (MACE) in patients with chest pain. We investigated the frequency, circumstances and potential consequences of errors in its calculation. METHODS: We performed a secondary analysis of a stepped wedge trial of patients with chest pain presenting to nine Dutch emergency departments. We recalculated HEART scores for all patients by re-evaluating the elements age (A), risk factors (R) and troponin (T) and compared these new scores with those given by physicians in daily practice. We investigated which circumstances increased the probability of incorrect scoring and explored the potential consequences. RESULTS: The HEART score was incorrectly scored in 266 out of 1752 patients (15.2%; 95% CI 13.5% to 16.9%). Most errors occurred in the R ('Risk factors') element (61%). Time of admission, and patient's age or gender did not contribute to errors, but more errors were made in patients with higher scores. In 102 patients (5.8%, 95% CI 4.7% to 6.9%) the incorrect HEART score resulted in incorrect risk categorisation (too low or too high). Patients with an incorrectly calculated HEART score had a higher risk of MACE (OR 1.85; 95% CI 1.37 to 2.50), which was largely related to more errors being made in patients with higher HEART scores. CONCLUSIONS: Our results show that the HEART score was incorrectly calculated in 15% of patients, leading to inappropriate risk categorisation in 5.8% which may have led to suboptimal clinical decision-making and management. Actions should be taken to improve the score's use in daily practice.

Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial.

BACKGROUND: The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score is an easy-to-apply instrument to stratify patients with chest pain according to their short-term risk for major adverse cardiac events (MACEs), but its effect on daily practice is unknown. OBJECTIVE: To measure the effect of use of the HEART score on patient outcomes and use of health care resources. DESIGN: Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT01756846). SETTING: Emergency departments in 9 Dutch hospitals. PATIENTS: Unselected patients with chest pain presenting at emergency departments in 2013 and 2014. INTERVENTION: All hospitals started with usual care. Every 6 weeks, 1 hospital was randomly assigned to switch to "HEART care," during which physicians calculated the HEART score to guide patient management. MEASUREMENTS: For safety, a noninferiority margin of a 3.0% absolute increase in MACEs within 6 weeks was set. Other outcomes included use of health care resources, quality of life, and cost-effectiveness. RESULTS: A total of 3648 patients were included (1827 receiving usual care and 1821 receiving HEART care). Six-week incidence of MACEs during HEART care was 1.3% lower than during usual care (upper limit of the 1-sided 95% CI, 2.1% [within the noninferiority margin of 3.0%]). In low-risk patients, incidence of MACEs was 2.0% (95% CI, 1.2% to 3.3%). No statistically significant differences in early discharge, readmissions, recurrent emergency department visits, outpatient visits, or visits to general practitioners were observed. LIMITATION: Physicians were hesitant to refrain from admission and diagnostic tests in patients classified as low risk by the HEART score. CONCLUSION: Using the HEART score during initial assessment of patients with chest pain is safe, but the effect on health care resources is limited, possibly due to nonadherence to management recommendations. PRIMARY FUNDING SOURCE: Netherlands Organisation for Health Research and Development.

Selecting patients with non-ST-elevation acute coronary syndrome for coronary angiography: a nationwide clinical vignette study in the Netherlands.

OBJECTIVE: Cardiac guidelines recommend that the decision to perform coronary angiography (CA) in patients with Non-ST-Elevation Acute Coronary Syndrome (NST-ACS) is based on multiple factors. It is, however, unknown how cardiologists weigh these factors in their decision-making. The aim was to investigate the importance of different clinical characteristics, including information derived from risk scores, in the decision-making of Dutch cardiologists regarding performing CA in patients with suspected NST-ACS. DESIGN: A web-based survey containing clinical vignettes. SETTING AND PARTICIPANTS: Registered Dutch cardiologists were approached to complete the survey, in which they were asked to indicate whether they would perform CA for 8 vignettes describing 7 clinical factors: age, renal function, known coronary artery disease, persistent chest pain, presence of risk factors, ECG findings and troponin levels. Cardiologists were divided into two groups: group 1 received vignettes 'without' a risk score present, while group 2 completed vignettes 'with' a risk score present. RESULTS: 129 (of 946) cardiologists responded. In both groups, elevated troponin levels and typical ischaemic changes (p<0.001) made cardiologists decide more often to perform CA. Severe renal dysfunction (p<0.001) made cardiologists more hesitant to decide on CA. Age and risk score could not be assessed independently, as these factors were strongly associated. Inspecting the factors together showed, for example, that cardiologists were more hesitant to perform CA in elderly patients with high-risk scores than in younger patients with intermediate risk scores. CONCLUSIONS: When deciding to perform in-hospital CA (≤72 hours after patient admission) in patients with suspected NST-ACS, cardiologists tend to rely mostly on troponin levels, ECG changes and renal function. Future research should focus on why CA is less often recommended in patients with severe renal dysfunction, and in elderly patients with high-risk scores. In addition, the impact of age and risk score on decision-making should be further investigated.

No Added Value of Novel Biomarkers in the Diagnostic Assessment of Patients Suspected of Acute Coronary Syndrome.

BACKGROUND: Despite the availability of high-sensitive troponin (hs-cTnT), there is still room for improvement in the diagnostic assessment of patients suspected of acute coronary syndrome (ACS). Apart from serial biomarker testing, which is time-consuming, novel biomarkers like copeptin have been proposed to expedite the early diagnosis of suspected ACS in addition to hs-cTnT. We determined whether placenta derived growth factor (PlGF), soluble Fms-like tyrosine kinase 1 (sFlt-1), myoglobin, N-terminal prohormone B-type Natriuretic Peptide (NT-proBNP), growth-differentiation factor 15 (GDF-15) and copeptin improved early assessment of chest pain patients. METHODS: This prospective, single centre diagnostic FAME-ER study included patients presenting to the ED with symptoms suggestive of ACS. Blood was collected to measure biomarkers, notably, hs-cTnT was retrospectively assessed. Added value of markers was judged by increase in AUC using multivariable logistic regression. RESULTS: Of 453 patients enrolled, 149 (33%) received a final diagnosis of ACS. Hs-cTnT had the highest diagnostic value in both univariable and multivariable analysis. PPVs of the biomarkers ranged from 23.5% (PlGF) to 77.9% (hs-cTnT), NPVs from 67.0% (PlGF) to 86.4% (hs-cTnT). Only myoglobin yielded diagnostic value in addition to clinical symptoms and electrocardiography (ECG) (AUC of clinical model 0.80) with AUC of 0.84 (p<0.001). However, addition of hs-cTnT was superior (AUC 0.89, p<0.001). Addition of the biomarkers to our clinical model and hs-cTnT did not or only marginally (GDF-15) improved diagnostic performance. CONCLUSION: When assessing patients suspected of ACS, only myoglobin had added diagnostic value beyond clinical symptoms and ECG. However, when combined with hs-cTnT, it yields no additional diagnostic value. PlGF, sFlt-1, NT-proBNP, GDF-15 and copeptin had no added value to the clinical model or hs-cTnT.

Clinical decision-making of cardiologists regarding admission and treatment of patients with suspected unstable angina or non-ST-elevation myocardial infarction: protocol of a clinical vignette study.

INTRODUCTION: Cardiologists face the difficult task of rapidly distinguishing cardiac-related chest pain from other conditions, and to thoroughly consider whether invasive diagnostic procedures or treatments are indicated. The use of cardiac risk-scoring instruments has been recommended in international cardiac guidelines. However, it is unknown to what degree cardiac risk scores and other clinical information influence cardiologists' decision-making. This paper describes the development of a binary choice experiment using realistic descriptions of clinical cases. The study aims to determine the importance cardiologists put on different types of clinical information, including cardiac risk scores, when deciding on the management of patients with suspected unstable angina or non-ST-elevation myocardial infarction. METHODS AND ANALYSIS: Cardiologists were asked, in a nationwide survey, to weigh different clinical factors in decision-making regarding patient admission and treatment using realistic descriptions of patients in which specific characteristics are varied in a systematic way (eg, web-based clinical vignettes). These vignettes represent patients with suspected unstable angina or non-ST-elevation myocardial infarction. Associations between several clinical characteristics, with cardiologists' management decisions, will be analysed using generalised linear mixed models. ETHICS AND DISSEMINATION: The study has received ethics approval and informed consent will be obtained from all participating cardiologists. The results of the study will provide insight into the relative importance of cardiac risk scores and other clinical information in cardiac decision-making. Further, the results indicate cardiologists' adherence to the European Society of Cardiology guideline recommendations. In addition, the detailed description of the method of vignette development applied in this study could assist other researchers or clinicians in creating future choice experiments.

The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial.

BACKGROUND: Chest pain remains a diagnostic challenge: physicians do not want to miss an acute coronary syndrome (ACS), but, they also wish to avoid unnecessary additional diagnostic procedures. In approximately 75% of the patients presenting with chest pain at the emergency department (ED) there is no underlying cardiac cause. Therefore, diagnostic strategies focus on identifying patients in whom an ACS can be safely ruled out based on findings from history, physical examination and early cardiac marker measurement. The HEART score, a clinical prediction rule, was developed to provide the clinician with a simple, early and reliable predictor of cardiac risk. We set out to quantify the impact of the use of the HEART score in daily practice on patient outcomes and costs. METHODS/DESIGN: We designed a prospective, multi-centre, stepped wedge, cluster randomised trial. Our aim is to include a total of 6600 unselected chest pain patients presenting at the ED in 10 Dutch hospitals during an 11-month period. All clusters (i.e. hospitals) start with a period of 'usual care' and are randomised in their timing when to switch to 'intervention care'. The latter involves the calculation of the HEART score in each patient to guide clinical decision; notably reassurance and discharge of patients with low scores and intensive monitoring and early intervention in patients with high HEART scores. Primary outcome is occurrence of major adverse cardiac events (MACE), including acute myocardial infarction, revascularisation or death within 6 weeks after presentation. Secondary outcomes include occurrence of MACE in low-risk patients, quality of life, use of health care resources and costs. DISCUSSION: Stepped wedge designs are increasingly used to evaluate the real-life effectiveness of non-pharmacological interventions because of the following potential advantages: (a) each hospital has both a usual care and an intervention period, therefore, outcomes can be compared within and across hospitals; (b) each hospital will have an intervention period which enhances participation in case of a promising intervention; (c) all hospitals generate data about potential implementation problems. This large impact trial will generate evidence whether the anticipated benefits (in terms of safety and cost-effectiveness) of using the HEART score will indeed be achieved in real-life clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov 80-82310-97-12154.

The predictive value of the exercise ECG for major adverse cardiac events in patients who presented with chest pain in the emergency department.

BACKGROUND: To improve early diagnostic and therapeutic decision making, we designed the HEART score for chest pain patients in the emergency department (ED). HEART is an acronym of its components: History, ECG, Age, Risk factors and Troponin. Currently, many chest pain patients undergo exercise testing on the consecutive days after presentation. However, it may be questioned how much diagnostic value the exercise ECG adds when the HEART score is already known. METHODS: A subanalysis was performed of a multicenter prospective validation study of the HEART score, consisting of 248 patients who underwent exercise testing within 7 days after presentation in the ED. Outcome is the predictive value of exercise testing in terms of major adverse cardiac events (MACE) within 6 weeks after presentation. RESULTS: In low-risk patients (HEART score ≤ 3), 63.1 % were negative tests, 28.6 % non-conclusive and 8.3 % positive; the latter were all false positives. In the intermediate-risk group (HEART score 4-6), 30.9 % were negative tests, 60.3 % non-conclusive and 8.8 % positive, half of these positives were false positives. In the high-risk patients (HEART score ≥ 7), 14.3 % were negative tests, 57.1 % non-conclusive and 28.6 % positive, of which half were false positives. CONCLUSION: In a chest pain population risk stratified with HEART, exercise testing has only a modest contribution to clinical decision making. 50 % of all tests are non-conclusive, with high rates of false positive tests in all three risk groups. In intermediate-risk patients, negative exercise tests may contribute to the exclusion of disease. Clinicians should rather go for sensitive tests, in particular in patients with low HEART scores.