Realising the full potential of the WHO Surgical Safety Checklist (SSC) to reduce perioperative h... more Realising the full potential of the WHO Surgical Safety Checklist (SSC) to reduce perioperative harm requires the constructive engagement of all operating room (OR) team members during its administration. To facilitate research on SSC implementation, a valid and reliable instrument is needed for measuring OR team behaviours during its administration. We developed a behaviourally anchored rating scale (BARS) for this purpose. We used a modified Delphi process, involving 16 subject matter experts, to compile a BARS with behavioural domains applicable to all three phases of the SSC. We evaluated the instrument in 80 adult OR cases and 30 simulated cases using two medical student raters and seven expert raters, respectively. Intraclass correlation coefficients were calculated to assess inter-rater reliability. Internal consistency and instrument discrimination were explored. Sample size estimates for potential study designs using the instrument were calculated. The Delphi process resulted in a BARS instrument (the WHOBARS) with five behavioural domains. Intraclass correlation coefficients calculated from the OR cases exceeded 0.80 for 80% of the instrument's domains across the SSC phases. The WHOBARS showed high internal consistency across the three phases of the SSC and ability to discriminate among surgical cases in both clinical and simulated settings. Fewer than 20 cases per group would be required to show a difference of 1 point between groups in studies of the SSC, where α=0.05 and β=0.8. We have developed a generic instrument for comprehensively rating the administration of the SSC and informing initiatives to realise its full potential. We have provided data supporting its capacity for discrimination, internal consistency and inter-rater reliability. Further psychometric evaluation is warranted.
Demonstrably accurate records facilitate clinical decision making, improve patient safety, provid... more Demonstrably accurate records facilitate clinical decision making, improve patient safety, provide better defense against frivolous lawsuits, and enable better medical policy decisions. Anesthesia Information Management Systems (AIMS) have the potential to improve on the accuracy and reliability of handwritten records. Interfaces with electronic recording systems within the hospital or wider community allow correlation of anesthesia relevant data with biochemistry laboratory results, billing sections, radiological units, pharmacy, earlier patient records, and other systems. Electronic storage of large and accurate datasets has lent itself to quality assurance, enhancement of patient safety, research, cost containment, scheduling, anesthesia training initiatives, and has even stimulated organizational change. The time for record making may be increased by AIMS, but in some cases has been reduced. The question of impact on vigilance is not entirely settled, but substantial negative ef...
Communication failures in healthcare are frequent and linked to adverse events and treatment erro... more Communication failures in healthcare are frequent and linked to adverse events and treatment errors. Simulation-based team training has been proposed to address this. We aimed to explore the feasibility of a simulation-based course for all members of the operating room (OR) team, and to evaluate its effectiveness. Members of experienced OR teams were invited to participate in three simulated clinical events using an integrated surgical and anesthesia model. We collected information on costs, Behavioural Marker of Risk Index (BMRI) (a measure of team information sharing) and participants' educational gains. We successfully recruited 20 full OR teams. Set up costs were NZ$50,000. Running costs per course were NZ$4,000, excluding staff. Most participants rated the course highly. BMRI improved significantly (P = 0.04) and thematic analysis identified educational gains for participants. We demonstrated feasibility of multidisciplinary simulation-based training for surgeons, anestheti...
... Reason J. Human error: models and management. BMJ. 2000;320:76870. Jensen LS, Merry AF, Webs... more ... Reason J. Human error: models and management. BMJ. 2000;320:76870. Jensen LS, Merry AF, Webster CS, Weller J, Larsson L. Evidence-based strategies for preventing drug administration errors during anaesthesia. Anaesthesia. 2004;59:493504. Webster CS, Merry AF. ...
Little is known about the sustainability and long-term effect of surgical safety checklists when ... more Little is known about the sustainability and long-term effect of surgical safety checklists when implemented in resource-limited settings. A previous study demonstrated the marked, short-term effect of a structured hospital-wide implementation of a surgical safety checklist in Moldova, a lower-middle-income country, as have studies in other low-resource settings. To assess the long-term reduction in perioperative harm following the introduction of a checklist-based surgical quality improvement program in a resource-limited setting and to understand the long-term effects of such programs. Twenty months after the initial implementation of a surgical safety checklist and the provision of pulse oximetry at a referral hospital in Moldova, a lower-middle-income, resource-limited country in Eastern Europe, we conducted a prospective study of perioperative care and outcomes of 637 consecutive patients undergoing noncardiac surgery (the long-term follow-up group), and we compared the finding...
The evidence is incontrovertible--we are inadvertently harming an unacceptable number of our pati... more The evidence is incontrovertible--we are inadvertently harming an unacceptable number of our patients by the very healthcare intended to help them. Most developed countries have responded to this evidence with substantial funding for dedicated patient-safety campaigns. New Zealand has a reasonable legislative foundation in relation to this problem but to date has not galvanised action at either the national or the organisational level. The reasons for this inaction are explored in this article and include a lack of understanding of the causes of medical error and of the difference between error and violation. Insistence on randomised controlled trial evidence and a business model is to misunderstand the constructs at stake and may inhibit the implementation of urgently needed safety strategies that are clearly sensible and worthwhile.
A safe and effective alternative is needed for patients in whom unfractionated heparin (UFH) or p... more A safe and effective alternative is needed for patients in whom unfractionated heparin (UFH) or protamine is contraindicated (e.g., those with heparin-induced thrombocytopenia or allergy to protamine). Furthermore, choice of anticoagulant may influence graft patency in coronary surgery and may therefore be important even when there is no contraindication to UFH. Direct thrombin inhibitors have several potential advantages over UFH, demonstrated in acute coronary syndromes. However, there are also potential difficulties with their use related to lack of reversal agents and paucity of clinical experience in monitoring their anticoagulant activity at the levels required for cardiac surgery with cardiopulmonary bypass (CPB). In the first prospective randomized trial of an alternative to heparin in cardiac surgery, we compared bivalirudin (a short-acting direct thrombin inhibitor) with UFH in 100 patients undergoing off-pump coronary artery bypass (OPCAB) surgery. Blood loss for the 12 hours following study drug initiation in the bivalirudin group was not significantly greater than in the heparin group. Median graft flow was significantly higher in the bivalirudin group. We concluded that anticoagulation for OPCAB surgery with bivalirudin was feasible without a clinically important increase in perioperative blood loss. A larger study is needed to investigate the impact of improved graft patency on other clinical outcomes after cardiac surgery.
We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, p... more We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, prospective, randomised study. Patients undergoing surgery, screened for contraindications to non-steroidal anti-inflammatory drug, received tenoxicam (n=750) on 2843 days or placebo (n=251) on 988 days, in courses of 1-12 days. There was no increase in the overall incidence of side effects with tenoxicam (33 vs 38% with placebo: P=0.15), or in major side effects (3.9 vs 2.0% with placebo: P=0.11). Of major side effects possibly or probably related to tenoxicam (2.1 vs 1.2% with placebo: P=0.26), all but one involved post-operative surgical site bleeding. However, in the subgroup of patients undergoing otorhinolaryngology surgery, surgical site bleeding occurred in 18 of 171 (10.5%) patients on tenoxicam and one of 57 (1.8%) on placebo (P=0.026); of these, nine in the tenoxicam group and 0 in the placebo were classified as major (P=0.07). One patient on tenoxicam experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicam is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than 1 in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding.
Medication errors in pediatric anesthesia represent an important risk to children. Concerted acti... more Medication errors in pediatric anesthesia represent an important risk to children. Concerted action to reduce harm from this cause is overdue. An understanding of the genesis of avoidable adverse drug events may facilitate the development of effective countermeasures to the events or their effects. Errors include those involving the automatic system of cognition and those involving the reflective system. Errors and violations are distinct, but violations often predispose to error. The system of medication administration is complex, and many aspects of it are conducive to error. Evidence-based practices to reduce the risk of medication error in general include those encompassed by the following recommendations: systematic countermeasures should be used to decrease the number of drug administration errors in anesthesia; the label on any drug ampoule or syringe should be read carefully before a drug is drawn up or injected; the legibility and contents of labels on ampoules and syringes should be optimized according to agreed standards; syringes should always be labeled; formal organization of drug drawers and workspaces should be used; labels should be checked with a second person or a device before a drug is drawn up or administered. Dosage errors are particularly common in pediatric patients. Causes that should be addressed include a lack of pediatric formulations and/or presentations of medication that necessitates dilution before administration or the use of intravenous formulations for oral administration in children, a frequent failure to obtain accurate weights for patients and a paucity of pharmacokinetic and pharmacodynamic data. Technological innovations, including the use of bar codes and various cognitive aids, may facilitate compliance with these recommendations. Improved medication safety requires a system-wide strategy standardized at least to the level of the institution; it is the responsibility of institutional leadership to introduce such strategies and of individual practitioners to engage in them.
Realising the full potential of the WHO Surgical Safety Checklist (SSC) to reduce perioperative h... more Realising the full potential of the WHO Surgical Safety Checklist (SSC) to reduce perioperative harm requires the constructive engagement of all operating room (OR) team members during its administration. To facilitate research on SSC implementation, a valid and reliable instrument is needed for measuring OR team behaviours during its administration. We developed a behaviourally anchored rating scale (BARS) for this purpose. We used a modified Delphi process, involving 16 subject matter experts, to compile a BARS with behavioural domains applicable to all three phases of the SSC. We evaluated the instrument in 80 adult OR cases and 30 simulated cases using two medical student raters and seven expert raters, respectively. Intraclass correlation coefficients were calculated to assess inter-rater reliability. Internal consistency and instrument discrimination were explored. Sample size estimates for potential study designs using the instrument were calculated. The Delphi process resulted in a BARS instrument (the WHOBARS) with five behavioural domains. Intraclass correlation coefficients calculated from the OR cases exceeded 0.80 for 80% of the instrument's domains across the SSC phases. The WHOBARS showed high internal consistency across the three phases of the SSC and ability to discriminate among surgical cases in both clinical and simulated settings. Fewer than 20 cases per group would be required to show a difference of 1 point between groups in studies of the SSC, where α=0.05 and β=0.8. We have developed a generic instrument for comprehensively rating the administration of the SSC and informing initiatives to realise its full potential. We have provided data supporting its capacity for discrimination, internal consistency and inter-rater reliability. Further psychometric evaluation is warranted.
Demonstrably accurate records facilitate clinical decision making, improve patient safety, provid... more Demonstrably accurate records facilitate clinical decision making, improve patient safety, provide better defense against frivolous lawsuits, and enable better medical policy decisions. Anesthesia Information Management Systems (AIMS) have the potential to improve on the accuracy and reliability of handwritten records. Interfaces with electronic recording systems within the hospital or wider community allow correlation of anesthesia relevant data with biochemistry laboratory results, billing sections, radiological units, pharmacy, earlier patient records, and other systems. Electronic storage of large and accurate datasets has lent itself to quality assurance, enhancement of patient safety, research, cost containment, scheduling, anesthesia training initiatives, and has even stimulated organizational change. The time for record making may be increased by AIMS, but in some cases has been reduced. The question of impact on vigilance is not entirely settled, but substantial negative ef...
Communication failures in healthcare are frequent and linked to adverse events and treatment erro... more Communication failures in healthcare are frequent and linked to adverse events and treatment errors. Simulation-based team training has been proposed to address this. We aimed to explore the feasibility of a simulation-based course for all members of the operating room (OR) team, and to evaluate its effectiveness. Members of experienced OR teams were invited to participate in three simulated clinical events using an integrated surgical and anesthesia model. We collected information on costs, Behavioural Marker of Risk Index (BMRI) (a measure of team information sharing) and participants' educational gains. We successfully recruited 20 full OR teams. Set up costs were NZ$50,000. Running costs per course were NZ$4,000, excluding staff. Most participants rated the course highly. BMRI improved significantly (P = 0.04) and thematic analysis identified educational gains for participants. We demonstrated feasibility of multidisciplinary simulation-based training for surgeons, anestheti...
... Reason J. Human error: models and management. BMJ. 2000;320:76870. Jensen LS, Merry AF, Webs... more ... Reason J. Human error: models and management. BMJ. 2000;320:76870. Jensen LS, Merry AF, Webster CS, Weller J, Larsson L. Evidence-based strategies for preventing drug administration errors during anaesthesia. Anaesthesia. 2004;59:493504. Webster CS, Merry AF. ...
Little is known about the sustainability and long-term effect of surgical safety checklists when ... more Little is known about the sustainability and long-term effect of surgical safety checklists when implemented in resource-limited settings. A previous study demonstrated the marked, short-term effect of a structured hospital-wide implementation of a surgical safety checklist in Moldova, a lower-middle-income country, as have studies in other low-resource settings. To assess the long-term reduction in perioperative harm following the introduction of a checklist-based surgical quality improvement program in a resource-limited setting and to understand the long-term effects of such programs. Twenty months after the initial implementation of a surgical safety checklist and the provision of pulse oximetry at a referral hospital in Moldova, a lower-middle-income, resource-limited country in Eastern Europe, we conducted a prospective study of perioperative care and outcomes of 637 consecutive patients undergoing noncardiac surgery (the long-term follow-up group), and we compared the finding...
The evidence is incontrovertible--we are inadvertently harming an unacceptable number of our pati... more The evidence is incontrovertible--we are inadvertently harming an unacceptable number of our patients by the very healthcare intended to help them. Most developed countries have responded to this evidence with substantial funding for dedicated patient-safety campaigns. New Zealand has a reasonable legislative foundation in relation to this problem but to date has not galvanised action at either the national or the organisational level. The reasons for this inaction are explored in this article and include a lack of understanding of the causes of medical error and of the difference between error and violation. Insistence on randomised controlled trial evidence and a business model is to misunderstand the constructs at stake and may inhibit the implementation of urgently needed safety strategies that are clearly sensible and worthwhile.
A safe and effective alternative is needed for patients in whom unfractionated heparin (UFH) or p... more A safe and effective alternative is needed for patients in whom unfractionated heparin (UFH) or protamine is contraindicated (e.g., those with heparin-induced thrombocytopenia or allergy to protamine). Furthermore, choice of anticoagulant may influence graft patency in coronary surgery and may therefore be important even when there is no contraindication to UFH. Direct thrombin inhibitors have several potential advantages over UFH, demonstrated in acute coronary syndromes. However, there are also potential difficulties with their use related to lack of reversal agents and paucity of clinical experience in monitoring their anticoagulant activity at the levels required for cardiac surgery with cardiopulmonary bypass (CPB). In the first prospective randomized trial of an alternative to heparin in cardiac surgery, we compared bivalirudin (a short-acting direct thrombin inhibitor) with UFH in 100 patients undergoing off-pump coronary artery bypass (OPCAB) surgery. Blood loss for the 12 hours following study drug initiation in the bivalirudin group was not significantly greater than in the heparin group. Median graft flow was significantly higher in the bivalirudin group. We concluded that anticoagulation for OPCAB surgery with bivalirudin was feasible without a clinically important increase in perioperative blood loss. A larger study is needed to investigate the impact of improved graft patency on other clinical outcomes after cardiac surgery.
We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, p... more We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, prospective, randomised study. Patients undergoing surgery, screened for contraindications to non-steroidal anti-inflammatory drug, received tenoxicam (n=750) on 2843 days or placebo (n=251) on 988 days, in courses of 1-12 days. There was no increase in the overall incidence of side effects with tenoxicam (33 vs 38% with placebo: P=0.15), or in major side effects (3.9 vs 2.0% with placebo: P=0.11). Of major side effects possibly or probably related to tenoxicam (2.1 vs 1.2% with placebo: P=0.26), all but one involved post-operative surgical site bleeding. However, in the subgroup of patients undergoing otorhinolaryngology surgery, surgical site bleeding occurred in 18 of 171 (10.5%) patients on tenoxicam and one of 57 (1.8%) on placebo (P=0.026); of these, nine in the tenoxicam group and 0 in the placebo were classified as major (P=0.07). One patient on tenoxicam experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicam is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than 1 in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding.
Medication errors in pediatric anesthesia represent an important risk to children. Concerted acti... more Medication errors in pediatric anesthesia represent an important risk to children. Concerted action to reduce harm from this cause is overdue. An understanding of the genesis of avoidable adverse drug events may facilitate the development of effective countermeasures to the events or their effects. Errors include those involving the automatic system of cognition and those involving the reflective system. Errors and violations are distinct, but violations often predispose to error. The system of medication administration is complex, and many aspects of it are conducive to error. Evidence-based practices to reduce the risk of medication error in general include those encompassed by the following recommendations: systematic countermeasures should be used to decrease the number of drug administration errors in anesthesia; the label on any drug ampoule or syringe should be read carefully before a drug is drawn up or injected; the legibility and contents of labels on ampoules and syringes should be optimized according to agreed standards; syringes should always be labeled; formal organization of drug drawers and workspaces should be used; labels should be checked with a second person or a device before a drug is drawn up or administered. Dosage errors are particularly common in pediatric patients. Causes that should be addressed include a lack of pediatric formulations and/or presentations of medication that necessitates dilution before administration or the use of intravenous formulations for oral administration in children, a frequent failure to obtain accurate weights for patients and a paucity of pharmacokinetic and pharmacodynamic data. Technological innovations, including the use of bar codes and various cognitive aids, may facilitate compliance with these recommendations. Improved medication safety requires a system-wide strategy standardized at least to the level of the institution; it is the responsibility of institutional leadership to introduce such strategies and of individual practitioners to engage in them.
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Papers by Alan Merry