Transforming operating rooms: factors for successful implementations of new medical equipment

Operating Rooms (OR’s) are complex, high tech environments with extensive use of medical equipment and information technology. The implementation of new medical equipment with the aim to increase safety, improve patient outcomes or to improve efficiency may initially cause disruptions in the OR, which influence its success. Between and within hospitals the implementation of medical equipment varies and a generic implementation model omits. The aim of this study is to identify factors for successful implementations according to surgical supportive staff. Results are compared with findings from other published studies. In total 90 out of 235 surveys were returned (38%). Respondents, scrub nurses and circulating nurses, indicate that implementation and integration of new medical equipment in current activities and ICT systems remain a challenge. In this study we identified the following factors: a coherent and holistic implementation approach; integration of medical equipment in processes, systems and organization; knowledge and skill development and effective communication during the implementation process

Peri-operative red blood cell transfusion in neonates and infants: NEonate and Children audiT of Anaesthesia pRactice IN Europe: A prospective European multicentre observational study

BACKGROUND: Little is known about current clinical practice concerning peri-operative red blood cell transfusion in neonates and small infants. Guidelines suggest transfusions based on haemoglobin thresholds ranging from 8.5 to 12 g dl-1, distinguishing between children from birth to day 7 (week 1), from day 8 to day 14 (week 2) or from day 15 (≥week 3) onwards. OBJECTIVE: To observe peri-operative red blood cell transfusion practice according to guidelines in relation to patient outcome. DESIGN: A multicentre observational study. SETTING: The NEonate-Children sTudy of Anaesthesia pRactice IN Europe (NECTARINE) trial recruited patients up to 60 weeks' postmenstrual age undergoing anaesthesia for surgical or diagnostic procedures from 165 centres in 31 European countries between March 2016 and January 2017. PATIENTS: The data included 5609 patients undergoing 6542 procedures. Inclusion criteria was a peri-operative red blood cell transfusion. MAIN OUTCOME MEASURES: The primary endpoint was the haemoglobin level triggering a transfusion for neonates in week 1, week 2 and week 3. Secondary endpoints were transfusion volumes, 'delta haemoglobin' (preprocedure - transfusion-triggering) and 30-day and 90-day morbidity and mortality. RESULTS: Peri-operative red blood cell transfusions were recorded during 447 procedures (6.9%). The median haemoglobin levels triggering a transfusion were 9.6 [IQR 8.7 to 10.9] g dl-1 for neonates in week 1, 9.6 [7.7 to 10.4] g dl-1 in week 2 and 8.0 [7.3 to 9.0] g dl-1 in week 3. The median transfusion volume was 17.1 [11.1 to 26.4] ml kg-1 with a median delta haemoglobin of 1.8 [0.0 to 3.6] g dl-1. Thirty-day morbidity was 47.8% with an overall mortality of 11.3%. CONCLUSIONS: Results indicate lower transfusion-triggering haemoglobin thresholds in clinical practice than suggested by current guidelines. The high morbidity and mortality of this NECTARINE sub-cohort calls for investigative action and evidence-based guidelines addressing peri-operative red blood cell transfusions strategies. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02350348

From accuracy to patient outcome and cost-effectiveness evaluations of diagnostic tests and biomarkers: an exemplary modelling study

BACKGROUND: Proper evaluation of new diagnostic tests is required to reduce overutilization and to limit potential negative health effects and costs related to testing. A decision analytic modelling approach may be worthwhile when a diagnostic randomized controlled trial is not feasible. We demonstrate this by assessing the cost-effectiveness of modified transesophageal echocardiography (TEE) compared with manual palpation for the detection of atherosclerosis in the ascending aorta. METHODS: Based on a previous diagnostic accuracy study, actual Dutch reimbursement data, and evidence from literature we developed a Markov decision analytic model. Cost-effectiveness of modified TEE was assessed for a life time horizon and a health care perspective. Prevalence rates of atherosclerosis were age-dependent and low as well as high rates were applied. Probabilistic sensitivity analysis was applied. RESULTS: The model synthesized all available evidence on the risk of stroke in cardiac surgery patients. The modified TEE strategy consistently resulted in more adapted surgical procedures and, hence, a lower risk of stroke and a slightly higher number of life-years. With 10% prevalence of atherosclerosis the incremental cost-effectiveness ratio was €4,651 and €481 per quality-adjusted life year in 55-year-old men and women, respectively. In all patients aged 65 years or older the modified TEE strategy was cost saving and resulted in additional health benefits. CONCLUSIONS: Decision analytic modelling to assess the cost-effectiveness of a new diagnostic test based on characteristics, costs and effects of the test itself and of the subsequent treatment options is both feasible and valuable. Our case study on modified TEE suggests that it may reduce the risk of stroke in cardiac surgery patients older than 55 years at acceptable cost-effectiveness levels

Typical rise and fall of troponin in (peri-procedural) myocardial infarction : A systematic review

AIM: To identify the typical shape of the rise and fall curve of troponin (Tn) following the different types of myocardial infarction (MI). METHODS: We conducted a systematic search in PubMed and Embase including all studies which focused on the kinetics of Tn in MI type 1, type 4 and type 5. Tn levels were standardized using the 99(th) percentile, a pooled mean with 95%CI was calculated from the weighted means for each time point until 72 h. RESULTS: A total of 34 of the 2528 studies identified in the systematic search were included. The maximum peak level of the Tn was seen after 6 h after successful reperfusion of an acute MI, after 12 h for type 1 MI and after 72 h for type 5 MI. In type 1 MI there were additional smaller peaks at 1 h and at 24 h. After successful reperfusion of an acute MI there was a second peak at 24 h. There was not enough data available to analyze the Tn release after MI associated with percutaneous coronary intervention (type 4). CONCLUSION: The typical rise and fall of Tn is different for type 1 MI, successful reperfusion of an acute MI and type 5 MI, with different timing of the peak levels and different slopes of the fall phase

Evaluating an Implementation Protocol for Digitization and Devices in Operating Rooms: a Case Study

Digitization of activities in hospitals receives more attention, due to Covid-19 related regulations. The use of e-health to support patient care is increasing and efficient ways to implement digitization of processes and other technological equipment are needed. We constructed a protocol for implementation and in this study, we evaluate this protocol based on a case to implement a device in the OR. We used various data sources to evaluate this protocol: semi-structured interviews, questionnaires, and project documents. Based on these findings, this protocol, including identified implementation activities and implementation instructions can be used for implementations of other devices. Implementation activities include setting up a project plan, organizational and technological preparation, maintenance, and training. In future research, these activities and instructions need to be evaluated in more complex projects and a flexible tool needs to be developed to select relevant activities and instructions for implementations of information systems or devices

Comparison of approaches to estimate confidence intervals of post-test probabilities of diagnostic test results in a nested case-control study

Abstract Background Nested case–control studies become increasingly popular as they can be very efficient for quantifying the diagnostic accuracy of costly or invasive tests or (bio)markers. However, they do not allow for direct estimation of the test’s predictive values or post-test probabilities, let alone for their confidence intervals (CIs). Correct estimates of the predictive values itself can easily be obtained using a simple correction by the (inverse) sampling fractions of the cases and controls. But using this correction to estimate the corresponding standard error (SE), falsely increases the number of patients that are actually studied, yielding too small CIs. We compared different approaches for estimating the SE and thus CI of predictive values or post-test probabilities of diagnostic test results in a nested case–control study. Methods We created datasets based on a large, previously published diagnostic study on 2 different tests (D-dimer test and calf difference test) with a nested case–control design. We compared six different approaches; the approaches were: 1. the standard formula for the SE of a proportion, 2. adaptation of the standard formula with the sampling fraction, 3. A bootstrap procedure, 4. A approach, which uses the sensitivity, the specificity and the prevalence, 5. Weighted logistic regression, and 6. Approach 4 on the log odds scale. The approaches were compared with respect to coverage of the CI and CI-width. Results The bootstrap procedure (approach 3) showed good coverage and relatively small CI widths. Approaches 4 and 6 showed some undercoverage, particularly for the D-dimer test with frequent positive results (positive results around 70%). Approaches 1, 2 and 5 showed clear overcoverage at low prevalences of 0.05 and 0.1 in the cohorts for all case–control ratios. Conclusion The results from our study suggest that a bootstrap procedure is necessary to assess the confidence interval for the predictive values or post-test probabilities of diagnostic tests results in studies using a nested case–control design.</p

Implementation of the third universal definition of myocardial infarction after coronary artery bypass grafting : a survey study in Western Europe

BACKGROUND: Diagnosing a postoperative myocardial infarction in patients undergoing coronary artery bypass grafting is challenging, as the normally used criteria are more difficult to interpret. The rate of implementation of the consensus-based new diagnostic criteria for postoperative myocardial infarction proposed by the third universal definition of myocardial infarction is unknown. Therefore, the primary objective of this study was to address the implementation of the third universal definition of postoperative myocardial infarction following coronary artery bypass grafting. METHODS AND RESULTS: We conducted a web-based survey by sending 4 waves of invitations via e-mail to cardiothoracic surgeons in 12 Western European countries. Of the 302 participating cardiothoracic specialists, from 182 different centers, 213 (71%) were aware that troponin is the preferred biomarker and 112 (37%) knew that using a cut-off level of >10 times the 99th percentile is recommended. Overall, 90 (30%) participants (strongly) agreed with implementation of this cut-off level in their clinical practice. Troponin was used in clinical practice by 149 (49%) of the participants. In total, 117 (89%) of the 131 participants with a local guideline confirmed ECG changes as a diagnostic criterion in that guideline. ST segmental changes (75, 64%) were used more often for diagnosing postoperative myocardial infarction than Q waves (64, 55%) or new left bundle branch blocks (34, 29%). CONCLUSIONS: Cardiac biomarkers and ECG changes were not used in concordance with the third universal definition, and only a minority had a positive attitude toward implementation of the proposed cut-off level for troponin in their clinical practice

Evaluation of an implementation protocol for digitization and devices in Operating Rooms

Implementing new information systems and devices, in high-reliability organizations such as operating rooms (OR\u27s) in hospitals, is complex. To improve the success and efficiency of these implementations we constructed a protocol for implementation for digitization and devices in OR’s. This protocol consists of implementation factors, implementation activities, and implementation instructions. In this study, we evaluated this protocol. To gather data, we organized three focus group sessions with participants holding different job roles at different departments: a surgeon, a methodologist, anesthesiologists, a scrub nurse, a training officer, innovations officers, and OR-management. We gathered qualitative data regarding completeness, clearness, and the ability to execute. Sessions were video-recorded, transcribed, and coded in Nvivo for Windows according to Toulmins Argumentative Pattern. Based on this analysis, revisions to factors, activities, and instructions are presented for protocol enhancement; experts confirm that an implementation protocol is needed to increase implementation efficiency and adoption of new devices

Déclaration des incidents critiques dans un hôpital de soins tertiaires : une étude de cohorte historique de 110 310 interventions

Purpose: Investigation of adverse events associated with anesthetic procedures is a method of quality control that identifies topics to improve clinical care and patient safety. Most research to date has been based on closed claim registries and anonymous reports which have specific limitations. Therefore, to evaluate a hospital’s reporting system, the present study was designed to describe critical incidents that anesthesiologists voluntarily and non-anonymously reported through an anesthesia information management system. Methods: This is a historical observational cohort study on patients (age > 18 yr) undergoing anesthetic procedures in a tertiary referral hospital. A 20-item list of complications, as developed by the Netherlands Society of Anesthesiologists, was prospectively completed for each procedure. All critical incidents registered in the anesthesia information management system were then reclassified into 95 different critical incidents in a reproducible way. Results: There were 110,310 procedures performed in 65,985 patients, and after excluding 158 reports that did not depict a critical incident, 3,904 critical incidents in 3,807 (3.5%) anesthetic procedures remained. Technical difficulties with regional anesthesia (n = 445; 40 per 10,000 anesthetics; 95% confidence interval [CI], 36 to 44), hypotension (n = 432; 39 per 10,000 anesthetics; 95% CI, 35 to 43), and unexpected difficult intubation (n = 216; 20 per 10,000 anesthetics; 95% CI, 18 to 23) were the most frequently documented critical incidents. Conclusion: Accurate measurement and monitoring of critical incidents is crucial for patient safety. Despite the risk of underreporting and probable misclassification of manual reporting systems, our results give a comprehensive overview on the occurrence of voluntarily reported anesthesia-related critical incidents. This overview can direct development of a new reporting system and preventive strategies to decrease the future occurrence of critical incidents