Preoperative Anticoagulation Management in Everyday Clinical Practice: An International Comparative Analysis of Work-as-Done Using the Functional Resonance Analysis Method.

OBJECTIVES: Preoperative anticoagulation management (PAM) is a complex, multidisciplinary process important to patient safety. The Functional Resonance Analysis Method (FRAM) is a novel method to study how complex processes usually go right at the frontline (labeled Safety-II) and how this relates to predefined procedures. This study aimed to assess PAM in everyday practice and explore the usability and utility of FRAM. METHODS: The study was conducted at an Australian and European Cardiothoracic Surgery Department. A FRAM model of work-as-imagined was developed using (inter)national guidelines. Semistructured interviews with 18 involved professionals were used to develop models reflecting work-as-done at both sites, which were presented to staff for validation. Workload in hours was estimated per process step. RESULTS: In both centers, work-as-done differed from work-as-imagined, such as in the division of tasks among disciplines (e.g., nurses/registrars rather than medical specialists), but control mechanisms had been developed locally to ensure safe care (e.g., crosschecking with other clinicians). Centers had organized the process differently, revealing opportunities for improvement regarding patient information and clustering of clinic visits. Presenting FRAM models to staff initiated discussion on improvement of functions in the model that are vital for success. Overall workload was estimated at 47 hours per site. CONCLUSIONS: This FRAM analysis provided insight into PAM from the perspective of frontline clinicians, revealing essential functions, interdependencies and variability, and the relation with guidelines. Future studies are warranted to study the potential of FRAM, such as for guiding improvements in complex systems.

How reliable is perioperative anticoagulant management? Determining guideline compliance and practice variation by a retrospective patient record review.

OBJECTIVES: Surgery in patients on anticoagulants requires careful monitoring and risk assessment to prevent harm. Required interruptions of anticoagulants and deciding whether to use bridging anticoagulation add further complexity. This process, known as perioperative anticoagulant management (PAM), is optimised by using guidelines. Optimal PAM prevents thromboembolic and bleeding complications. The purpose of this study was to assess the reliability of PAM practice in Dutch hospitals. Additionally, the variations between hospitals and different bridging dosages were studied. DESIGN: A multicentre retrospective patient record review. SETTING AND PARTICIPANTS: Records from 268 patients using vitamin-K antagonist (VKA) anticoagulants who underwent surgery in a representative random sample of 13 Dutch hospitals were reviewed, 259 were analysed. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome measure was the reliability of PAM expressed as the percentage of patients receiving guideline compliant care. Seven PAM steps were included. Secondary outcome measures included different bridging dosages used and an analysis of practice variation on the hospital level. RESULTS: Preoperative compliance was lowest for timely VKA interruptions: 58.8% (95% CI 50.0% to 67.7%) and highest for timely preoperative assessments: 81% (95% CI 75.0% to 86.5%). Postoperative compliance was lowest for timely VKA restarts: 39.9% (95% CI 33.1% to 46.7%) and highest for the decision to apply bridging: 68.5% (95% CI 62.3% to 74.8%). Variation in compliance between hospitals was present for the timely preoperative assessment (range 41%-100%), international normalised ratio testing (range 21%-94%) and postoperative bridging (range 20%-88%). Subtherapeutic bridging was used in 50.5% of patients and increased with patients' weight. CONCLUSIONS: Unsatisfying compliance for most PAM steps, reflect suboptimal reliability of PAM. Furthermore, the hospital performance varied. This increases the risk for adverse events, warranting quality improvement. The development of process measures can help but will be complicated by the availability of a strong supporting evidence base and integrated care delivery regarding PAM.

Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

Antithrombotic drugs are consistently involved in medication-related adverse events (MRAEs) in hospitalized patients. We aimed to estimate the antithrombotic-related adverse event (ARAE) incidence between 2008 and 2016 and analyse their clinical context in hospitalized patients in The Netherlands. A post-hoc analysis of three national studies, aimed at adverse event (AE) identification, was performed. Previously identified AEs were screened for antithrombotic involvement. Crude and multi-level, case-mix adjusted ARAE and MRAE incidences were calculated. Various contextual ARAE characteristics were analysed. ARAE incidence between 2008 and 2016 decreased significantly in in-hospital deceased patients from 1.20% (95% confidence interval (CI): 0.63-2.27%) in 2008 to 0.54% (95% CI: 0.27-1.11%) in 2015/2016 (p = 0.02). In discharged patients ARAE incidence remained stable. By comparison, overall MRAE incidence remained stable for both deceased and discharged patients. Most ARAEs involved Vitamin-K antagonists (VKAs). Preventable ARAEs occurred more during weekends and with increasing multidisciplinary involvement. Antiplatelet and combined antithrombotic use seemed to be increasingly involved in ARAEs over time. ARAE incidence declined by 55% in deceased patients between 2008 and 2016. Opportunities for improving antithrombotic safety should target INR monitoring and care delivery aspects such as multidisciplinary involvement and weekend care. Future ARAE monitoring for the involvement of antiplatelet, combined antithrombotic and direct oral anticoagulant (DOAC) use is recommended.

The cost-utility of point-of-care troponin testing to diagnose acute coronary syndrome in primary care.

BACKGROUND: The added value of using a point-of-care (POC) troponin test in primary care to rule out acute coronary syndrome (ACS) is debated because test sensitivity is inadequate early after symptom onset. This study investigates the potential cost-utility of diagnosing ACS by a general practitioner (GP) when a POC troponin test is available versus GP assessment only. METHODS: A patient-level simulation model was developed, representing a hypothetical cohort of the Dutch population (>35 years) consulting the GP with chest complaints. All health related consequences as well as cost consequences were included. Both symptom duration, selection of patients in whom the POC troponin test is performed, and test performance at different time points were incorporated. Health outcomes were expressed as Quality-Adjusted Life Years (QALYs). The main outcome parameters involve the effect of POC troponin testing on (in)correct hospital referrals, QALYs, and costs. RESULTS: The POC troponin strategy decreases the referral rate in non-ACS patients from 38.46% to 31.85%. Despite a small increase in non-referral among ACS patients from 0.22% to 0.27%, the overall health effect is negligible. Costs will decrease with €77.25/patient (95% CI €-126.81 to €-33.37). CONCLUSIONS: The POC troponin strategy is likely cost-saving, by reducing hospital referrals. The small increase in missed ACS patients can be partly explained by conservative assumptions used in the analysis. Besides, current developments in POC troponin tests will likely further improve their diagnostic performance. Therefore, future prospective studies are warranted to investigate whether those developments make the POC troponin test to a safe and cost-effective diagnostic tool for diagnosing ACS in general practices.