Drug errors in anaesthesia: technology, systems and culture

Annually in Britain, iatrogenic harm results in patient deaths, increased morbidity, and millions of pounds spent on additional healthcare. Errors in the administration of drugs have been identified as a leading cause of patient harm in major international reports,1 2 and the literature also suggests that most practicing anaesthetists have experienced at least one drug error.34 Methods of conventional drug administration in anaesthesia are idiosyncratic, relatively error prone, and make little use of technology to support manual checking. While there is support for the use of double-checking during anaesthesia practice, the availability of a second person during every drug administration, and issues around hierarchy and recognised automaticity in checking 5 can potentially be the limitations. Currently there has been little work carried out in the UK in relation to the use of double checking protocols and there remains a need for a robust check that can be implemented within the National Health Service (NHS). The first study explored the feasibility of introducing a double check methodology, either second-person confirmation or electronic confirmation into clinical practice within the NHS. This was the first study of this nature within the NHS and explored the attitudes, barriers and benefits of each method. The second study was designed to explore the beliefs and attitudes of anaesthetists and Operating Department Practitioners (ODPs) on introducing technology which is designed to reduce drug error. This study also explored in greater depth the culture issues raised in the first study and the impact of introducing the electronic confirmation on the anaesthetist’s workload. The findings suggested that while many participants acknowledged that the process of second person double checking was an important factor to minimise the opportunity of any unsafe medication administration, the process of second person confirmation could be prone to human manipulation and could alter the behaviour and practice of the anaesthetist, resulting in a reluctance to adopt it. The electronic confirmation method was found to be more feasible. It did not rely on the presence of a second person at the time of drug administration, and did not impact on the anaesthetist’s workload. This thesis has shown that technology was more readily accepted and seen as more feasible to use by anaesthetists within their clinical practice. However, these studies have also shown that the culture and beliefs of the organisation and individuals, in particular of ‘blame and shame’, has such a strong influence that it continues to prevent a true safety culture developing into an open culture of reporting incidents, recognising that drug errors remain a problem, and that corrective measures are required to prevent them

Effect of a Perioperative, Cardiac Output-Guided Hemodynamic Therapy Algorithm on Outcomes Following Major Gastrointestinal Surgery A Randomized Clinical Trial and Systematic Review

Importance: small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm.Objective: to evaluate the clinical effectiveness of a perioperative, cardiac output–guided hemodynamic therapy algorithm.Design, setting, and participants: OPTIMISE was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom. An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014.Interventions: patients were randomly assigned to a cardiac output–guided hemodynamic therapy algorithm for intravenous fluid and inotrope (dopexamine) infusion during and 6 hours following surgery (n=368) or to usual care (n=366).Main outcomes and measures: the primary outcome was a composite of predefined 30-day moderate or major complications and mortality. Secondary outcomes were morbidity on day 7; infection, critical care–free days, and all-cause mortality at 30 days; all-cause mortality at 180 days; and length of hospital stay.Results: baseline patient characteristics, clinical care, and volumes of intravenous fluid were similar between groups. Care was nonadherent to the allocated treatment for less than 10% of patients in each group. The primary outcome occurred in 36.6% of intervention and 43.4% of usual care participants (relative risk [RR], 0.84 [95% CI, 0.71-1.01]; absolute risk reduction, 6.8% [95% CI, ?0.3% to 13.9%]; P?=?.07). There was no significant difference between groups for any secondary outcomes. Five intervention patients (1.4%) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group. Findings of the meta-analysis of 38 trials, including data from this study, suggest that the intervention is associated with fewer complications (intervention, 488/1548 [31.5%] vs control, 614/1476 [41.6%]; RR, 0.77 [95% CI, 0.71-0.83]) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality (intervention, 159/3215 deaths [4.9%] vs control, 206/3160 deaths [6.5%]; RR, 0.82 [95% CI, 0.67-1.01]) and mortality at longest follow-up (intervention, 267/3215 deaths [8.3%] vs control, 327/3160 deaths [10.3%]; RR, 0.86 [95% CI, 0.74-1.00]).Conclusions and relevance: in a randomized trial of high-risk patients undergoing major gastrointestinal surgery, use of a cardiac output–guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality. However, inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rate

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

Background: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. Methods: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. Findings: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96–1·28). Interpretation: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. Funding: National Institute for Health Research Health Services and Delivery Research Programme

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme

Drug errors in anaesthesia : technology, systems and culture

Annually in Britain, iatrogenic harm results in patient deaths, increased morbidity, and millions of pounds spent on additional healthcare. Errors in the administration of drugs have been identified as a leading cause of patient harm in major international reports,1 2 and the literature also suggests that most practicing anaesthetists have experienced at least one drug error.34 Methods of conventional drug administration in anaesthesia are idiosyncratic, relatively error prone, and make little use of technology to support manual checking. While there is support for the use of double-checking during anaesthesia practice, the availability of a second person during every drug administration, and issues around hierarchy and recognised automaticity in checking 5 can potentially be the limitations. Currently there has been little work carried out in the UK in relation to the use of double checking protocols and there remains a need for a robust check that can be implemented within the National Health Service (NHS). The first study explored the feasibility of introducing a double check methodology, either second-person confirmation or electronic confirmation into clinical practice within the NHS. This was the first study of this nature within the NHS and explored the attitudes, barriers and benefits of each method. The second study was designed to explore the beliefs and attitudes of anaesthetists and Operating Department Practitioners (ODPs) on introducing technology which is designed to reduce drug error. This study also explored in greater depth the culture issues raised in the first study and the impact of introducing the electronic confirmation on the anaesthetist’s workload. The findings suggested that while many participants acknowledged that the process of second person double checking was an important factor to minimise the opportunity of any unsafe medication administration, the process of second person confirmation could be prone to human manipulation and could alter the behaviour and practice of the anaesthetist, resulting in a reluctance to adopt it. The electronic confirmation method was found to be more feasible. It did not rely on the presence of a second person at the time of drug administration, and did not impact on the anaesthetist’s workload. This thesis has shown that technology was more readily accepted and seen as more feasible to use by anaesthetists within their clinical practice. However, these studies have also shown that the culture and beliefs of the organisation and individuals, in particular of ‘blame and shame’, has such a strong influence that it continues to prevent a true safety culture developing into an open culture of reporting incidents, recognising that drug errors remain a problem, and that corrective measures are required to prevent them.EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Learning from a successful process evaluation in care homes

Introductionprocess evaluations (PE) are increasingly used in parallel with randomised controlled trials (RCT) to inform the implementation of complex health interventions. This paper explores the learning accrued from conducting a PE within the Falls in Care Homes Study (FinCH), a large UK RCT.Methodsin the FinCH study, six purposively sampled care homes provided data for the PE, which followed a realist approach. In this study researchers kept written diaries of their experiences in completing the interviews, focus groups and observations. We have reflected on these and present the main themes for discussion.Findingscare home staff were enthusiastic to participate in the PE but researchers found it difficult to collect data due to staff not having time to take part, environmental factors such as no space for focus groups and low levels of research understanding. Researchers found that the expectations of the PE protocol were often unrealistic due to these limitations. Flexible and pragmatic approaches such as interviews in place of focus groups enabled data collection but required a reduced sample size and length of data collection to be accepted by researchers.Conclusionto enable care home staff to participate in successful PEs, researchers should build flexibility into research schedules, spend time building trust, collaborate with all levels of care home staff prior to data collection, increase research capacity in care home staff and co-design research projects

Qualitative Analysis of the Cognition and Flow (CoGFlowS) Study: An Individualized Approach to Cognitive Training for Dementia Is Needed.

BackgroundCognitive training (CT) may have benefits for both healthy older adults (HC) and those with early cognitive disorders [mild cognitive impairment (MCI) and dementia]. However, few studies have qualitatively evaluated home-based, computerized CT programs.ObjectiveWe present the qualitative arm of a feasibility randomized controlled trial evaluating a CT program for HC and people living with MCI or dementia.MethodsParticipants underwent semi-structured interviews after 12 weeks of CT. Where possible, participants were interviewed with their carers. The interview schedule and analysis were underpinned by the health belief model. Interviews were audio-recorded, transcribed, open-coded, and categorized into themes. The analytical framework was developed, and themes were condensed under five major categories: benefits, barriers, threat, self-efficacy, and cues to action.Results37 participants underwent interviews. CT was feasible and acceptable to participants. Benefits included: enjoyment, improved awareness, benchmarking cognitive function, reassurance of abilities and giving back control. Barriers were more prevalent among those with dementia: problems with technology, frustration, conflict between patients and carers, apathy and lack of insight, anxiety or low mood, and lack of portability. HC and MCI perceived the severity of dementia risk as high, partially mitigated by CT. Participants living with dementia valued a more individualized approach to training, accounting for baseline characteristics.ConclusionCT was a feasible intervention for HC and people living with dementia and MCI. Benefits were present, but the identified barriers need to be addressed for CT to be implemented successfully

The Cognition and Flow Study (CogFlowS): A Mixed Method Evaluation of a Randomized Feasibility Trial of Cognitive Training in Dementia.

BackgroundCognitive training (CT) may be beneficial in delaying the onset or slowing dementia progression. CT has been evaluated quantitatively and qualitatively, but none have used mixed methods approaches.ObjectiveThe aim of this study was to use a mixed methods approach to identify those who may selectively benefit from CT.MethodsThis was an explanatory sequential mixed methods study involving a quantitative randomized trial of 12 weeks multi-domain CT in healthy older adults (HC, n = 20), and people living with mild cognitive impairment (MCI; n = 12) and dementia (n = 24). Quantitative outcomes included: cognition, mood, quality of life, and activities of daily living. 28 (10 HC, 6 MCI, 12 dementia) training participants completed semi-structured interviews with their carer. Quantitative and qualitative data were integrated using joint displays.ResultsThree participants dropped out from the training early-on, leaving 25 participants with follow-up data for full integration (10 HC, 6 MCI, 9 dementia). Dropouts and lower adherence to training were more common in dementia participants with greater non-modifiable barriers. High adherers were more resilient to negative emotions, and poorer or fluctuating performance. Integrated analysis found the majority of participants (n = 24) benefited across outcomes, with no clear profile of individuals who benefited more than others. Participants made a number of key recommendations to improve adherence and minimize dropout to CT.ConclusionReasons for dropout and low adherence were identified, with recommendations provided for the design of CT for dementia. An individual approach to training should be adopted and low adherence should not preclude engagement with CT