Automating sedation state assessments using natural language processing.

INTRODUCTION: Common goals for procedural sedation are to control pain and ensure the patient is not moving to an extent that is impeding safe progress or completion of the procedure. Clinicians perform regular assessments of the adequacy of procedural sedation in accordance with these goals to inform their decision-making around sedation titration and also for documentation of the care provided. Natural language processing could be applied to real-time transcriptions of audio recordings made during procedures in order to classify sedation states that involve movement and pain, which could then be integrated into clinical documentation systems. The aim of this study was to determine whether natural language processing algorithms will work with sufficient accuracy to detect sedation states during procedural sedation. DESIGN: A prospective observational study was conducted. METHODS: Audio recordings from consenting participants undergoing elective procedures performed in the interventional radiology suite at a large academic hospital were transcribed using an automated speech recognition model. Sentences of transcribed text were used to train and evaluate several different NLP pipelines for a text classification task. The NLP pipelines we evaluated included a simple Bag-of-Words (BOW) model, an ensemble architecture combining a linear BOW model and a "token-to-vector" (Tok2Vec) component, and a transformer-based architecture using the RoBERTa pre-trained model. RESULTS: A total of 15,936 sentences from transcriptions of 82 procedures was included in the analysis. The RoBERTa model achieved the highest performance among the three models with an area under the ROC curve (AUC-ROC) of 0.97, an F1 score of 0.87, a precision of 0.86, and a recall of 0.89. The Ensemble model showed a similarly high AUC-ROC of 0.96, but lower F1 score of 0.79, precision of 0.83, and recall of 0.77. The BOW approach achieved an AUC-ROC of 0.97 and the F1 score was 0.7, precision was 0.83 and recall was 0.66. CONCLUSION: The transformer-based architecture using the RoBERTa pre-trained model achieved the best classification performance. Further research is required to confirm the that this natural language processing pipeline can accurately perform text classifications with real-time audio data to allow for automated sedation state assessments. CLINICAL RELEVANCE: Automating sedation state assessments using natural language processing pipelines would allow for more timely documentation of the care received by sedated patients, and, at the same time, decrease documentation burden for clinicians. Downstream applications can also be generated from the classifications, including for example real-time visualizations of sedation state, which may facilitate improved communication of the adequacy of the sedation between clinicians, who may be performing supervision remotely. Also, accumulation of sedation state assessments from multiple procedures may reveal insights into the efficacy of particular sedative medications or identify procedures where the current approach for sedation and analgesia is not optimal (i.e. a significant amount of time spent in "pain" or "movement" sedation states).

Integrated pulmonary index during procedural sedation and analgesia: A cluster-randomized trial.

AIM: To evaluate the effectiveness of utilizing the integrated pulmonary index for capnography implementation during sedation administered by nurses. DESIGN: Cluster-randomized trial. METHODS: Participants were enrolled from the interventional radiology department at an academic hospital in Canada. Nurses were randomized to either enable or disable the Integrated Pulmonary Index feature of the capnography monitor. Procedures were observed by a research assistant to collect information about alarm performance characteristics. The primary outcome was the number of seconds in an alert condition state without an intervention being applied. RESULTS: The number of seconds in an alarm state without intervention was higher in the group that enabled the integrated pulmonary index compared to the group that disabled this feature, but this difference did not reach statistical significance. Likewise, the difference between groups for the total alarm duration, total number of alarms and the total number of appropriate alarms was not statistically significant. The number of inappropriate alarms was higher in the group that enabled the Integrated Pulmonary Index, but this estimate was highly imprecise. There was no difference in the odds of an adverse event (measured by the Tracking and Reporting Outcomes of Procedural Sedation tool) occurring between groups. Desaturation events were uncommon and brief in both groups but the area under the SpO2 90% desaturation curve scores were lower for the group that enabled the integrated pulmonary index. CONCLUSION: Enabling the integrated pulmonary index during nurse-administered procedural sedation did not reduce nurses' response times to alarms. Therefore, integrating multiple physiological parameters related to respiratory assessment into a single index did not lower the threshold for intervention by nurses. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The time it takes to respond to capnography monitor alarms will not be reduced if the integrated pulmonary Iindex feature of capnography monitors is enabled during nurse-administered procedural sedation. IMPACT: Results do not support the routine enabling of the integrated pulmonary index when nurses use capnography to monitor patients during procedural sedation as a strategy to reduce the time it takes to initiate responses to alarms. REPORTING METHOD: CONSORT. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution. TRIAL REGISTRATION: This study was prospectively registered at ClinicalTrials.gov (ID: NCT05068700).

Predicting Blood Pressure After Nitroglycerin Infusion Dose Titration in Critical Care Units: A Multicenter Retrospective Study.

Critical care nurses use physiological indicators, such as blood pressure, to guide their decision-making regarding the titration of nitroglycerin infusions. A retrospective study was conducted to determine the accuracy of systolic blood pressure predictions during nitroglycerin infusions. Data were extracted from the publicly accessible eICU program database. The accuracy of a linear model, least absolute shrinkage and selection operator, ridge regression, and a stacked ensemble model trained using the AutoGluon-Tabular framework were investigated. A persistence model, where the future value in a time series is predicted as equal to its preceding value, was used as the baseline comparison for model accuracy. Internal-external validation was used to examine if heterogeneity among hospitals could contribute to model performance. The sample consisted of 827 patients and 2541 nitroglycerin dose titrations with corresponding systolic blood pressure measurements. The root-mean-square error on the test set for the stacked ensemble model developed using the AutoGluon-Tabular framework was the lowest of all models at 15.3 mm Hg, equating to a 22% improvement against the baseline. Internal-external validation revealed consistent accuracy across hospitals. Further studies are needed to determine the impact of using systolic blood pressure predictions to inform nurses' clinical decision-making regarding nitroglycerin infusion titration in critical care.

An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 1 Foundational Knowledge.

Artificial intelligence (AI) is rapidly evolving and has transformative potential for interventional radiology (IR) clinical practice. However, formal training in AI may be limited for many clinicians and therefore presents a challenge for initial implementation and trust in AI. An understanding of the foundational concepts in AI may help familiarize the interventional radiologist with the field of AI, thus facilitating understanding and participation in the development and deployment of AI. A pragmatic classification system of AI based on the complexity of the model may guide clinicians in the assessment of AI. Finally, the current state of AI in IR and the patterns of implementation are explored (pre-procedural, intra-procedural, and post-procedural).

Design Specifications for an Automated System to Deliver Instructions About Preprocedure Fasting.

PURPOSE: Many patients undergoing surgical and other medical procedures requiring sedation or anesthesia receive standardized "no eating or drinking after midnight" instructions. This "standardized" instruction does not change regardless of potential alterations in scheduling that result in significant delays in procedure start times. As a result, the duration of preprocedure fasting often far exceeds recommended requirements. A technological solution that automates the delivery of preprocedure fasting instructions to patients would likely improve the patient experience. The purpose of this study was to determine design specifications for the delivery of notifications to patients as part of an automated system. DESIGN: A qualitative study was conducted with 14 adult participants using the persona-scenario method. METHODS: Participants worked in groups to create realistic but fictitious personas and scenarios that described how individuals like themselves would interact with an automated preprocedure fasting instruction system. Data generated through the development of the scenarios were analyzed to first identify important themes, which were then interpreted into design specifications. FINDINGS: Seven women and seven men, aged 25 to 75, developed 9 persona-scenarios, which captured outpatient and inpatient preprocedure fasting experiences, as well as perspectives of individuals who were not comfortable with technology, or those for which English was not the primary spoken language. Most scenarios described preprocedure fasting instructions delivered by an automated bidirectional short message service system. Two major themes were identified as patient priorities, including: (1) enhancing communication between patients and healthcare providers; and (2) the importance of using simple technology so that a greater number of patients with varying degrees of comfort and capabilities would be able to use the system confidently. A corresponding set of proposed design specifications was devised. CONCLUSIONS: The results of this study provide actionable ways to operationalize patient-centered ideas in the design of an automated preprocedure fasting instruction system.

Deep learning classification of capnography waveforms: secondary analysis of the PRODIGY study.

Capnography monitors trigger high priority 'no breath' alarms when CO2 measurements do not exceed a given threshold over a specified time-period. False alarms occur when the underlying breathing pattern is stable, but the alarm is triggered when the CO2 value reduces even slightly below the threshold. True 'no breath' events can be falsely classified as breathing if waveform artifact causes an aberrant spike in CO2 values above the threshold. The aim of this study was to determine the accuracy of a deep learning approach to classifying segments of capnography waveforms as either 'breath' or 'no breath'. A post hoc secondary analysis of data from 9 North American sites included in the PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY) study was conducted. We used a convolutional neural network to classify 15 s capnography waveform segments drawn from a random sample of 400 participants. Loss was calculated over batches of 32 using the binary cross-entropy loss function with weights updated using the Adam optimizer. Internal-external validation was performed by iteratively fitting the model using data from all but one hospital and then assessing its performance in the remaining hospital. The labelled dataset consisted of 10,391 capnography waveform segments. The neural network's accuracy was 0.97, precision was 0.97 and recall was 0.96. Performance was consistent across hospitals in internal-external validation. The neural network could reduce false capnography alarms. Further research is needed to compare the frequency of alarms derived from the neural network with the standard approach.

Integrated Pulmonary Index during nurse-administered procedural sedation: Study protocol for a cluster-randomized trial.

AIM: To determine if smart alarm-guided treatment of respiratory depression using the Integrated Pulmonary Index is an effective way to implement capnography during nurse-administered sedation. DESIGN: Parallel cluster-randomized trial. METHODS: Nurses will be randomized to use capnography with or without the Integrated Pulmonary Index enabled. Capnography alarm performance will be compared between nurses using capnography alone or with the Integrated Pulmonary Index enabled. The target sample size is 400 adult patients scheduled for elective procedures with nurse-administered sedation. The primary outcome is the number of seconds in an alert condition state without an intervention being applied. Secondary outcomes are alarm burden, number of appropriate alarms, number of inappropriate alarms, total duration of alert conditions, choice of alarm settings and adverse sedation events. This study has been funded since April 2021. DISCUSSION: Implementing capnography into practice for respiratory monitoring during nurse-administered sedation is considered a high priority. The Integrated Pulmonary Index shows promise as a strategy to optimize the implementation of capnography for respiratory monitoring during nurse-administered sedation. If it is found in this study that using the Integrated Pulmonary Index improves the nursing management of physiologically abnormal states during nurse-administered sedation, it would provide the high-level evidence needed to support broader use of this 'smart alarm' strategy for respiratory monitoring in practice. IMPACT: With advances in medical technology continuing to expand the indications for minimally invasive surgical techniques, the use of nurse-administered sedation during medical procedures is likely to expand in the future. The findings may be applied to other populations receiving nurse-administered sedation during medical procedures. Results from this study will help translate the usage of smart alarm-guided treatment of respiratory depression during procedural sedation. TRIAL REGISTRATION: NCT05068700.

High flow nasal oxygen during procedural sedation for cardiac implantable electronic device procedures: A randomised controlled trial.

BACKGROUND: High flow nasal oxygen may better support the vulnerable respiratory state of patients during procedural sedation. OBJECTIVE: The objective of this study was to investigate the effects of high flow nasal oxygen in comparison to facemask oxygen on ventilation during cardiac implantable electronic device procedures performed with procedural sedation. DESIGN: A randomised controlled trial. SETTING: The study was conducted at one academic hospital in Canada. PARTICIPANTS: Adults undergoing elective cardiac implantable electronic device procedures with sedation administered by an anaesthesia assistant, supervised by an anaesthesiologist from August 2019 to March 2020. INTERVENTIONS: Participants were randomised 1 : 1 to facemask (≥ 8 l ·â€Šmin-1) or high flow nasal oxygen (50 l ·â€Šmin-1 and a 50 : 50 oxygen to air ratio). MAIN OUTCOME MEASURES: The primary outcome was peak transcutaneous carbon dioxide. Outcomes were analysed using Bayesian statistics. RESULTS: The 129 participants who were randomised and received sedation were included. The difference in peak transcutaneous carbon dioxide was 0.0 kPa (95% CI -0.17 to 0.18). Minor adverse sedation events were 6.4 times more likely to occur in the high flow nasal oxygen group. This estimate is imprecise (95% CI 1.34 to 42.99). The odds ratio for oxygen desaturation for the high flow nasal oxygen group compared with the facemask group was 1.2 (95% CI 0.37 to 3.75). The difference in satisfaction with sedation scores between groups was 0.0 (95% CI -0.33 to 0.23). CONCLUSIONS: Ventilation, as measured by TcCO2, is highly unlikely to differ by a clinically important amount between high flow nasal oxygen at 50 l min-1 or facemask oxygen at 8 l min-1. Further research with a larger sample size would be required to determine the optimal oxygen:air ratio when using high flow nasal oxygen during cardiac implantable electronic device procedures performed with sedation. TRIAL REGISTRATION NUMBER: NCT03858257.

Accuracy and precision of zero-heat-flux temperature measurements with the 3M™ Bair Hugger™ Temperature Monitoring System: a systematic review and meta-analysis.

Zero-heat-flux thermometers provide clinicians with the ability to continuously and non-invasively monitor body temperature. These devices are increasingly being used to substitute for more invasive core temperature measurements during surgery and in critical care. The aim of this review was to determine the accuracy and precision of zero-heat-flux temperature measurements from the 3M™ Bair Hugger™ Temperature Monitoring System. Medline and EMBASE were searched for studies that reported on a measurement of core or peripheral temperature that coincided with a measurement from the zero-heat-flux device. Study selection and quality assessment was performed independently using the Revised Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2). The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to summarize the strength of the evidence. Pooled estimates of the mean bias and limits of agreement with outer 95% confidence intervals (population limits of agreement) were calculated. Sixteen studies were included. The primary meta-analysis of zero-heat-flux versus core temperature consisted of 22 comparisons from 16 individual studies. Data from 952 participants with 314,137 paired measurements were included. The pooled estimate for the mean bias was 0.03 °C. Population limits of agreement, which take into consideration the between-study heterogeneity and sampling error, were wide, spanning from - 0.93 to 0.98 °C. The GRADE evidence quality rating was downgraded to moderate due to concerns about study limitations. Population limits of agreement for the sensitivity analysis restricted to studies rated as having low risk of bias across all the domains of the QUADAS-2 were similar to the primary analysis. The range of uncertainty in the accuracy of a thermometer should be taken into account when using this device to inform clinical decision-making. Clinicians should therefore consider the potential that a temperature measurement from a 3M™ Bair Hugger™ Temperature Monitoring System could be as much as 1 °C higher or lower than core temperature. Use of this device may not be appropriate in situations where a difference in temperature of less than 1 °C is important to detect.

Effectiveness of nurse-led clinics in the early discharge period after percutaneous coronary intervention: A systematic review.

BACKGROUND: Readmission after percutaneous coronary intervention is common in the early postdischarge period, often linked to limited opportunity for education and preparation for self-care. Attending a nurse-led clinic within 30 d after discharge has the potential to enhance health outcomes. OBJECTIVE: The aim of the study was to synthesise the available literature on the effectiveness of nurse-led clinics, during early discharge (up to 30 d), for patients who have undergone percutaneous coronary intervention. REVIEW METHOD USED: A systematic review of randomised and quasi-randomised controlled trials was undertaken. DATA SOURCES: The databases included PubMed, OVID, CINAHL, EMBASE, the Cochrane Library, SCOPUS, and ProQuest. REVIEW METHODS: Databases were searched up to November 2018. Two independent reviewers assessed studies using the Cochrane risk-of-bias tool. RESULTS: Of 2970 articles screened, only four studies, representing 244 participants, met the review inclusion criteria. Three of these studies had low to moderate risk of bias, with the other study unclear. Interventions comprised physical assessments and individualised education. Reported outcomes included quality of life, medication adherence, cardiac rehabilitation attendance, and psychological symptoms. Statistical pooling was not feasible owing to heterogeneity across interventions, outcome measures, and study reporting. Small improvements in quality of life and some self-management behaviours were reported, but these changes were not sustained over time. CONCLUSIONS: This review has identified an important gap in the research examining the effectiveness of early postdischarge nurse-led support after percutaneous coronary intervention on outcomes for patients and health services. More robust research with sufficiently powered sample sizes and clearly defined interventions, comparison groups, and outcomes is recommended to determine effectiveness of nurse-led clinics in the early discharge period.

Accuracy of the PHQ-2 Alone and in Combination With the PHQ-9 for Screening to Detect Major Depression: Systematic Review and Meta-analysis.

Importance: The Patient Health Questionnaire depression module (PHQ-9) is a 9-item self-administered instrument used for detecting depression and assessing severity of depression. The Patient Health Questionnaire-2 (PHQ-2) consists of the first 2 items of the PHQ-9 (which assess the frequency of depressed mood and anhedonia) and can be used as a first step to identify patients for evaluation with the full PHQ-9. Objective: To estimate PHQ-2 accuracy alone and combined with the PHQ-9 for detecting major depression. Data Sources: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, and Web of Science (January 2000-May 2018). Study Selection: Eligible data sets compared PHQ-2 scores with major depression diagnoses from a validated diagnostic interview. Data Extraction and Synthesis: Individual participant data were synthesized with bivariate random-effects meta-analysis to estimate pooled sensitivity and specificity of the PHQ-2 alone among studies using semistructured, fully structured, or Mini International Neuropsychiatric Interview (MINI) diagnostic interviews separately and in combination with the PHQ-9 vs the PHQ-9 alone for studies that used semistructured interviews. The PHQ-2 score ranges from 0 to 6, and the PHQ-9 score ranges from 0 to 27. Results: Individual participant data were obtained from 100 of 136 eligible studies (44 318 participants; 4572 with major depression [10%]; mean [SD] age, 49 [17] years; 59% female). Among studies that used semistructured interviews, PHQ-2 sensitivity and specificity (95% CI) were 0.91 (0.88-0.94) and 0.67 (0.64-0.71) for cutoff scores of 2 or greater and 0.72 (0.67-0.77) and 0.85 (0.83-0.87) for cutoff scores of 3 or greater. Sensitivity was significantly greater for semistructured vs fully structured interviews. Specificity was not significantly different across the types of interviews. The area under the receiver operating characteristic curve was 0.88 (0.86-0.89) for semistructured interviews, 0.82 (0.81-0.84) for fully structured interviews, and 0.87 (0.85-0.88) for the MINI. There were no significant subgroup differences. For semistructured interviews, sensitivity for PHQ-2 scores of 2 or greater followed by PHQ-9 scores of 10 or greater (0.82 [0.76-0.86]) was not significantly different than PHQ-9 scores of 10 or greater alone (0.86 [0.80-0.90]); specificity for the combination was significantly but minimally higher (0.87 [0.84-0.89] vs 0.85 [0.82-0.87]). The area under the curve was 0.90 (0.89-0.91). The combination was estimated to reduce the number of participants needing to complete the full PHQ-9 by 57% (56%-58%). Conclusions and Relevance: In an individual participant data meta-analysis of studies that compared PHQ scores with major depression diagnoses, the combination of PHQ-2 (with cutoff ≥2) followed by PHQ-9 (with cutoff ≥10) had similar sensitivity but higher specificity compared with PHQ-9 cutoff scores of 10 or greater alone. Further research is needed to understand the clinical and research value of this combined approach to screening.

Pre-apneic capnography waveform abnormalities during procedural sedation and analgesia.

Capnography monitoring is recommended for use during procedural sedation. This study examined associations between capnography waveform abnormalities and the onset of apnea. Capnography waveforms from a sample of 102 participants undergoing moderate procedural sedation with bolus doses of midazolam and fentanyl were analyzed using a mixed effects Cox model. Patients were at increased risk of apnea (classified as end-tidal carbon dioxide concentration of zero) while demonstrating a capnography waveform abnormality classified as hypopnea (more than 10% increase or decrease from baseline end-tidal carbon dioxide concentration) (Hazard Ratio 2.14; 95% CI 1.75 to 2.62). Risk of apnea was not increased during capnography waveform abnormalities classified as bradypnea (capnography-derived respiratory rate less than 8 breaths/min) (Hazard Ratio 0.64; 95% CI 0.33 to 1.25). These estimates were similar when apneic episodes were defined as only those that lasted more than 20 s duration. Deciphering which capnography waveform abnormalities should promote intervention (and therefore alarms to signal the event to clinicians) from those that do not is an essential step towards successful implementation of this technology into practice. Our results indicate that using information about the history of previous capnography waveform abnormalities may be a promising solution to assist prediction of apneic episodes.

Avoiding and Managing Error in Interventional Radiology Practice: Tips and Tools.

While there are limited data on error in interventional radiology (IR), the literature so far indicates that many errors in IR are potentially preventable. Yet, understanding the sources for error and implementing effective countermeasures can be challenging. Traditional methods for reducing error such as increased vigilance and new policies may be effective but can also contribute to an "error cycle." A hierarchy of effectiveness for patient safety interventions is outlined, and the characteristics of "high-reliability" organizations in other "high-risk" industries are examined for clues that could be implemented in IR. The evidence behind team error reduction strategies such as checklists is considered along with individual approaches such as "slowing down when you should." However, error in medicine is inevitable, and this article also seeks to outline an evidence-based approach to managing the psychological impact of being involved in medical error as a physician.

Accuracy and precision of transcutaneous carbon dioxide monitoring: a systematic review and meta-analysis.

BACKGROUND: Transcutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. The aim of this review was to determine the accuracy and precision of TcCO2 measurements. METHODS: Medline and EMBASE (2000-2016) were searched for studies that reported on a measurement of PaCO2 that coincided with a measurement of TcCO2. Study selection and quality assessment (using the revised Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2)) were performed independently. The Grading Quality of Evidence and Strength of Recommendation approach was used to summarise the strength of the body of evidence. Pooled estimates of the mean bias between TcCO2 and PaCO2 and limits of agreement with outer 95% CIs (termed population limits of agreement) were calculated. RESULTS: The mean bias was -0.1 mm Hg and the population limits of agreement were -15 to 15 mm Hg for 7021 paired measurements taken from 2817 participants in 73 studies, which was outside of the clinically acceptable range (7.5 mm Hg). The lowest PaCO2 reported in the studies was 18 mm Hg and the highest was 103 mm Hg. The major sources of inconsistency were sensor location and temperature. The population limits of agreement were within the clinically acceptable range across 3974 paired measurements from 1786 participants in 44 studies that applied the sensor to the earlobe using the TOSCA and Sentec devices (-6 to 6 mm Hg). CONCLUSION: There are substantial differences between TcCO2 and PaCO2 depending on the context in which this technology is used. TcCO2 sensors should preferentially be applied to the earlobe and users should consider setting the temperature of the sensor higher than 42°C when monitoring at other sites. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO; CRD42017057450.

Theory-based strategies for teaching evidence-based practice to undergraduate health students: a systematic review.

BACKGROUND: Undergraduate students across health professions are required to be capable users of evidence in their clinical practice after graduation. Gaining the essential knowledge and clinical behaviors for evidence-based practice can be enhanced by theory-based strategies. Limited evidence exists on the effect of underpinning undergraduate EBP curricula with a theoretical framework to support EBP competence. A systematic review was conducted to determine the effectiveness of EBP teaching strategies for undergraduate students, with specific focus on efficacy of theory-based strategies. METHODS: This review critically appraised and synthesized evidence on the effectiveness of EBP theory-based teaching strategies specifically for undergraduate health students on long or short-term change in multiple outcomes, including but not limited to, EBP knowledge and attitudes. PubMed, CINAHL, Scopus, ProQuest Health, ERIC, The Campbell Collaboration, PsycINFO were searched for published studies and The New York Academy of Medicine, ProQuest Dissertations and Mednar were searched for unpublished studies. Two independent reviewers assessed studies using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument. RESULTS: Twenty-eight studies reporting EBP teaching strategies were initially selected for review with methodological quality ranging from low to high. Studies varied in course duration, timing of delivery, population and course content. Only five included papers reported alignment with, and detail of, one or more theoretical frameworks. Theories reported included Social Cognitive Theory (one study), Roger's Diffusion of Innovation Theory (two studies) and Cognitive Apprenticeship Theory (one study). Cognitive Flexibility Theory and Cognitive Load Theory were discussed in two separate papers by the same authors. All but one study measured EBP knowledge. Mixed results were reported on EBP knowledge, attitudes and skills across the five studies. CONCLUSIONS: EBP programs for undergraduate health students require consideration of multiple domains, including clinical behaviors, attitudes and cognitive learning processes; Interventions grounded in theory were found to have a small but positive effect on EBP attitudes. The most effective theory for developing and supporting EBP capability is not able to be determined by this review therefore additional rigorous research is required.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Cost-effectiveness of forced air warming during sedation in the cardiac catheterisation laboratory.

AIM: The aim of this study was to determine the cost-effectiveness of forced air warming (FAW) during sedation in a cardiac catheterisation laboratory. BACKGROUND: Forced air warming improves thermal comfort in comparison with standard care. It is not known whether the extra costs required for FAW are good value. DESIGN: Cost-effectiveness analysis alongside a randomized controlled trial conducted in 2016-2017. METHODS: A cost-effectiveness analysis was undertaken using Monte Carlo simulations from input distributions to estimate costs and effects associated with using FAW to reduce risk of thermal discomfort for patients receiving sedation in a cardiac catheterisation laboratory. A range of willingness to pay threshold values were tested with results plotted on a cost-effectiveness acceptability curve. Costs were calculated in Australian currency ($AUD). RESULTS: Estimated total costs were $5.21 (SD 3.26) higher per patient for FAW in comparison to standard care. Estimated probability of success (rating of thermal comfort) was 0.16 (0.06) higher for FAW. Forced air warming becomes more likely to result in a net benefit than standard care at a willingness to pay threshold of $34. CONCLUSION: Forced air warming could be considered cost-effective for procedures performed with sedation in a cardiac catheterisation laboratory if the extra cost of an incremental gain in thermal comfort is less than the decision maker's willingness to pay for it. Therefore, those responsible for decision-making regarding use of FAW in the cardiac catheterisation laboratory can use results of our model to decide if it represents good value for their organisation.

High quality of evidence is uncommon in Cochrane systematic reviews in Anaesthesia, Critical Care and Emergency Medicine.

BACKGROUND: The association between the quality of evidence in systematic reviews and authors' conclusions regarding the effectiveness of interventions relevant to anaesthesia has not been examined. OBJECTIVE: The objectives of this study were: to determine the proportion of systematic reviews in which the authors made a conclusive statement about the effect of an intervention; to describe the quality of evidence derived from outcomes in reviews that used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group system for grading the quality of evidence; and to identify review characteristics associated with conclusiveness. DESIGN: Cross-sectional analysis of Cochrane systematic reviews from the Anaesthesia, Critical Care and Emergency Review Group was undertaken. DATA SOURCES: The Cochrane webpage was used to identify reviews for inclusion (http://.ace.cochrane.org/). ELIGIBILITY CRITERIA: New and updated versions of systematic reviews published up to 17 September 2015 were eligible. Protocols for systematic reviews were excluded. RESULTS: A total of 159 reviews were included. GRADE was used in 103 reviews (65%). Of these, high-level evidence for the primary outcome was identified in 11 reviews (10%). The main reasons that quality of evidence for the primary outcome was downgraded were risk of bias (n = 44; 43%) and imprecision (n = 36; 35%). Authors of 47% (n = 75) of the total number of reviews made conclusive statements about the effects of interventions. Independent predictors of conclusiveness in the subgroup of reviews with GRADE assessments were quality of evidence for the primary outcome (odds ratio 2.03; 95% confidence interval: [1.18 to 3.52] and an increasing number of studies included in reviews (OR 1.05; 95% CI: [1.01 to 1.09]). CONCLUSION: It was common for conclusive statements to be made about the effects of interventions despite evidence for the primary outcome being rated less than high quality. Improving methodological quality of trials would have the greatest impact on improving the quality of evidence.

Midazolam for sedation before procedures.

BACKGROUND: Midazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous system (CNS) with rapid onset of action and few adverse effects. The drug can be administered by several routes including oral, intravenous, intranasal and intramuscular. OBJECTIVES: To determine the evidence on the effectiveness of midazolam for sedation when administered before a procedure (diagnostic or therapeutic). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL to January 2016), MEDLINE in Ovid (1966 to January 2016) and Ovid EMBASE (1980 to January 2016). We imposed no language restrictions. SELECTION CRITERIA: Randomized controlled trials in which midazolam, administered to participants of any age, by any route, at any dose or any time before any procedure (apart from dental procedures), was compared with placebo or other medications including sedatives and analgesics. DATA COLLECTION AND ANALYSIS: Two authors extracted data and assessed risk of bias for each included study. We performed a separate analysis for each different drug comparison. MAIN RESULTS: We included 30 trials (2319 participants) of midazolam for gastrointestinal endoscopy (16 trials), bronchoscopy (3), diagnostic imaging (5), cardioversion (1), minor plastic surgery (1), lumbar puncture (1), suturing (2) and Kirschner wire removal (1). Comparisons were: intravenous diazepam (14), placebo (5) etomidate (1) fentanyl (1), flunitrazepam (1) and propofol (1); oral chloral hydrate (4), diazepam (2), diazepam and clonidine (1); ketamine (1) and placebo (3); and intranasal placebo (2). There was a high risk of bias due to inadequate reporting about randomization (75% of trials). Effect estimates were imprecise due to small sample sizes. None of the trials reported on allergic or anaphylactoid reactions. Intravenous midazolam versus diazepam (14 trials; 1069 participants)There was no difference in anxiety (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.39 to 1.62; 175 participants; 2 trials) or discomfort/pain (RR 0.60, 95% CI 0.24 to 1.49; 415 participants; 5 trials; I² = 67%). Midazolam produced greater anterograde amnesia (RR 0.45; 95% CI 0.30 to 0.66; 587 participants; 9 trials; low-quality evidence). Intravenous midazolam versus placebo (5 trials; 493 participants)One trial reported that fewer participants who received midazolam were anxious (3/47 versus 15/35; low-quality evidence). There was no difference in discomfort/pain identified in a further trial (3/85 in midazolam group; 4/82 in placebo group; P = 0.876; very low-quality evidence). Oral midazolam versus chloral hydrate (4 trials; 268 participants)Midazolam increased the risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; moderate-quality evidence). Oral midazolam versus placebo (3 trials; 176 participants)Midazolam reduced pain (midazolam mean 2.56 (standard deviation (SD) 0.49); placebo mean 4.62 (SD 1.49); P < 0.005) and anxiety (midazolam mean 1.52 (SD 0.3); placebo mean 3.97 (SD 0.44); P < 0.0001) in one trial with 99 participants. Two other trials did not find a difference in numerical rating of anxiety (mean 1.7 (SD 2.4) for 20 participants randomized to midazolam; mean 2.6 (SD 2.9) for 22 participants randomized to placebo; P = 0.216; mean Spielberger's Trait Anxiety Inventory score 47.56 (SD 11.68) in the midazolam group; mean 52.78 (SD 9.61) in placebo group; P > 0.05). Intranasal midazolam versus placebo (2 trials; 149 participants)Midazolam induced sedation (midazolam mean 3.15 (SD 0.36); placebo mean 2.56 (SD 0.64); P < 0.001) and reduced the numerical rating of anxiety in one trial with 54 participants (midazolam mean 17.3 (SD 18.58); placebo mean 49.3 (SD 29.46); P < 0.001). There was no difference in meta-analysis of results from both trials for risk of incomplete procedures (RR 0.14, 95% CI 0.02 to 1.12; downgraded to low-quality evidence). AUTHORS' CONCLUSIONS: We found no high-quality evidence to determine if midazolam, when administered as the sole sedative agent prior to a procedure, produces more or less effective sedation than placebo or other medications. There is low-quality evidence that intravenous midazolam reduced anxiety when compared with placebo. There is inconsistent evidence that oral midazolam decreased anxiety during procedures compared with placebo. Intranasal midazolam did not reduce the risk of incomplete procedures, although anxiolysis and sedation were observed. There is moderate-quality evidence suggesting that oral midazolam produces less effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures.

Forced air warming to maintain normoTHERMIa during SEDation in the cardiac catheterization laboratory: protocol for the THERMISED pilot randomized controlled trial.

AIM: To determine whether applying forced air warming attenuates the impact of sedation-induced impairment of thermoregulation on body temperature of patients who are sedated during interventional procedures in the cardiac catheterization laboratory. BACKGROUND: A moderate proportion of sedated patients who undergo procedures in the cardiac catheterization laboratory with only passive warming become hypothermic. Hypothermia in the surgical population is associated with increased risk of adverse cardiac events, infections, thrombotic and haemorrhagic complications and prolonged hospital stay. For this reason, investigation of the clinical benefits of preventing hypothermia in sedated patients using active warming is required. DESIGN: Randomized controlled trial. METHODS: A total of 140 participants undergoing elective interventional procedures with sedation in a cardiac catheterization laboratory will be recruited from two hospitals in Australia. Participants will be randomized to receive forced air warming (active warming) or usual care (passive warming with heated cotton blankets) throughout procedures. The primary outcome is hypothermia (defined as temperature less than 36°C) at the conclusion of the procedure. Secondary outcomes are postprocedure temperature, postprocedural shivering, thermal discomfort, major complications, disability-free survival to 30 days postprocedure, cost-effectiveness and feasibility of conducting a larger clinical trial. DISCUSSION: The results from this study will provide high-level evidence for practice in an area where there is currently no guidance. Findings will be easily translatable into clinical practice because most hospitals already have forced air warming equipment available for use during general anaesthesia. REGISTRATION NUMBER: ACTRN12616000013460.