Objective: To discuss practical strategies to consider for morbidity and mortality conferences (M & M). Materials and Methods: This article reflects on (i) insights that can be drawn from the M... Show moreObjective: To discuss practical strategies to consider for morbidity and mortality conferences (M & M). Materials and Methods: This article reflects on (i) insights that can be drawn from the M & M literature, (ii) practical aspects to consider when organizing M & M, and (iii) possible future directions for development for this long-standing practice for routine reflection. Results: M & M offers the opportunity to learn from past cases in order to improve the care delivered to future patients, thereby serving both educational and quality improvement purposes. For departments seeking to implement or improve local M & M practice, it is difficult that a golden standard or best practice for M & M is nonexistent. This is partly because comparative research on different formats is hampered by the lack of objective outcome measures to evaluate the effectiveness of M & M. Common practical suggestions include the use of (i) a skillful and active moderator; (ii) structured formats for case presentation and discussion; and (iii) a dedicated committee to guide improvement plans that ensue from the meeting. M & M practice is affected by various sociological factors, for which qualitative research methods seem most suitable, but in the M & M literature these are sparsely used. Moreover, aspects influencing an open and blame-free atmosphere underline how local teams should tailor the format to best fit the local context and culture. Conclusion: This article presents practice guidance on how to organize and carry out M & M This practice for routine reflection needs to be tailored to the local setting, with attention for various sociological factors that are at play. Show less
Tresfon, J.; Langeveld, K.; Brunsveld-Reinders, A.H.; Hamming, J. 2023
Physical restraints are viewed as potentially dangerous objects for patient safety. Contemporary efforts mainly focus on preventing bad outcomes in restraint use, while little attention is paid... Show morePhysical restraints are viewed as potentially dangerous objects for patient safety. Contemporary efforts mainly focus on preventing bad outcomes in restraint use, while little attention is paid under what circumstances physical restraints are applied harmlessly. The aim of this research was to understand how physical restraints are used by neurology/neurosurgery ward nurses in relation to the protocol. In ethnographic action research, the Functional Resonance Analysis Method (FRAM) was used to map and compare physical restraints as part of daily ward care against the protocol of physical restraints. Comparison between protocol and actual practice revealed that dealing with restlessness and confusion is a collective nursing skill vital in dealing with physical restraints, while the protocol failed to account for these aspects. Supporting and maintaining this skillset throughout this and similar nursing teams can prevent future misguided application physical restraints, offering valuable starting point in managing patient safety for these potentially dangerous objects. Show less
Background: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs... Show moreBackground: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs. Objective: This study explored clinicians' perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework. Methods: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions. Results: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity. Conclusions: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. Show less
Background: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs... Show moreBackground: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs.Objective: This study explored clinicians’ perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework.Methods: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions.Results: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity.Conclusions: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. Show less
Background: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs... Show moreBackground: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs.Objective: This study explored clinicians’ perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework.Methods: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions.Results: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity.Conclusions: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. Show less
Background: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs... Show moreBackground: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs.Objective: This study explored clinicians’ perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework.Methods: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions.Results: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity.Conclusions: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. Show less
Tresfon, J.; Brunsveld-Reinders, A.H.; Valkenburg, D. van; Langeveld, K.; Hamming, J. 2022
Introduction: Modern safety approaches in healthcare differentiate between daily practice (work-as-done) and the written rules and guidelines (work-as-imagined) as a means to further develop... Show moreIntroduction: Modern safety approaches in healthcare differentiate between daily practice (work-as-done) and the written rules and guidelines (work-as-imagined) as a means to further develop patient safety. Research in this area has shown case study examples, but to date lacks hooking points as to how results can be embedded within the studied context. This study uses Functional Analysis Resonance Method (FRAM) for aligning work-as-imagined with the work-as-done. The aim of this study is to show how FRAM can effectively be applied to identify the gap between work prescriptions and practice, while subsequently showing how such findings can be transferred back to, and embedded in, the daily ward care process of nurses. Methods: This study was part of an action research performed among ward nurses on a 38 bed neurological and neurosurgical ward within a tertiary referral centre. Data was collected through document analysis, in-field observations, interviews and group discussions. FRAM was used as an analysis tool to model the prescribed working methods, actual practice and the gap between those two in the use of physical restraints on the ward. Results This study was conducted in four parts. In the exploration phase, work-as-imagined and work-as-done were mapped. Next, a gap between the concerns named in the protocol and the actual employed methods of dealing with physical restraint on the ward was identified. Subsequently, alignment efforts led to the co-construction of a new working method with the ward nurses, which was later embedded in quality efforts by a restraint working group on the ward. Conclusion The use of FRAM proved to be very effective in comparing work-as-done with work-as-imagined, contributing to a better understanding, evaluation and support of everyday performance in a ward care setting. Show less
Background Indwelling urinary catheters (IDUCs) are associated with complications and early removal is therefore essential. Currently, it is unknown what the effect of a specific removal time is... Show moreBackground Indwelling urinary catheters (IDUCs) are associated with complications and early removal is therefore essential. Currently, it is unknown what the effect of a specific removal time is and what the consequences of this removal time are. Research question To present an overview of the available evidence to determine the effects of three postoperative IDUC removal times (after a certain number of hours, at a specific time of day and flexible removal time) on the development of complications in hospital. Methods PubMed, Medline, Embase, Emcare and Cochrane Central Register of Controlled Trials were searched till 6 June, 2021. Studies were included that described the effect of the removal time in relation to re-catheterisation, urinary tract infections (UTIs), ambulation time, time of first voiding and hospital stay. The quality of the studies was assessed with the Newcastle-Ottawa Scale and the Cochrane Effective Practice and Organisation of Care. A narrative descriptive analysis was performed. PRISMA guidelines were followed in reporting this review. Results Twenty studies were included from which 18 compared removal after a number of hours, 1 reported on a specific removal time and 1 reported on both topics. The results were contradicting regarding the hypothesis that later removal increases the incidence of UTIs. Earlier removal does not lead to a higher re-catheterisation rate while immediate removal is beneficial for reducing the time to first ambulation and shortening the hospital stay. Studies reporting on specific removal times did not find differences in outcomes. No study addressed flexible removal time. Conclusions There is inconclusive evidence that earlier removal results in less UTIs, despite the incidence of UTIs increasing if the IDUC is removed >= 24 h. Immediate or after 1-2 day(s) removal does not lead to higher re-catheterisation rates while immediate removal results in earlier ambulation and shorter length of hospital stay. Implications of key findings Nurses should focus on early IDUC removal while being aware of urinary retention. Show less
Verhagen, M.J.; Vos, M.S. de; Smaggus, A.; Hamming, J.F. 2022
Objective Efforts to study morbidity and mortality conferences (M&MC) are hampered by the lack of rigorous instruments to assess the effectiveness of the conferences for the purpose of quality... Show moreObjective Efforts to study morbidity and mortality conferences (M&MC) are hampered by the lack of rigorous instruments to assess the effectiveness of the conferences for the purpose of quality improvement and medical education. This might limit further advancement of the practice. The aim of this scoping review was to determine commonly used effectiveness measures of M&MC in the literature. Method A scoping review was performed of quantitative, qualitative, and mixed methods studies of M&MC, using databases from PubMed, Emcare, Embase, Web of Science, and the Cochrane library. Studies were included if an outcome was described after a general evaluation or an intervention to M&MC. Study quality was assessed with the Quality Assessment Tool for Studies with Diverse Designs. Results A total of 43 articles were included in the review. The majority used a quantitative (n = 23) or mixed (n = 17) design, with surveys as the most frequent method used for data collection (n = 29). The overall Quality Assessment Tool for Studies with Diverse Designs scores were modest (64%). Outcome measures used to evaluate the effectiveness of M&MC were clustered in the following categories: "participant experiences," "characteristics of the meeting," "medical knowledge," "actions for improvement," and "clinical outcomes." Conclusions This review found a wide variety of effectiveness measures for M&MC. Rather than using isolated measures, approaches that combine multiple effectiveness measures could offer a more comprehensive assessment of M&MC. Although there was a preference for quantitative metrics, this fails to seize the opportunity of qualitative methods to yield insights into sociological purposes of M&MC, such as building professional identities and safety culture. Show less
Verhagen, M.J.; Vos, M.S. de; Sujan, M.; Hamming, J.F. 2022
ObjectivesPreoperative anticoagulation management (PAM) is a complex, multidisciplinary process important to patient safety. The Functional Resonance Analysis Method (FRAM) is a novel method to... Show moreObjectivesPreoperative anticoagulation management (PAM) is a complex, multidisciplinary process important to patient safety. The Functional Resonance Analysis Method (FRAM) is a novel method to study how complex processes usually go right at the frontline (labeled Safety-II) and how this relates to predefined procedures. This study aimed to assess PAM in everyday practice and explore the usability and utility of FRAM. MethodsThe study was conducted at an Australian and European Cardiothoracic Surgery Department. A FRAM model of work-as-imagined was developed using (inter)national guidelines. Semistructured interviews with 18 involved professionals were used to develop models reflecting work-as-done at both sites, which were presented to staff for validation. Workload in hours was estimated per process step. ResultsIn both centers, work-as-done differed from work-as-imagined, such as in the division of tasks among disciplines (e.g., nurses/registrars rather than medical specialists), but control mechanisms had been developed locally to ensure safe care (e.g., crosschecking with other clinicians). Centers had organized the process differently, revealing opportunities for improvement regarding patient information and clustering of clinic visits. Presenting FRAM models to staff initiated discussion on improvement of functions in the model that are vital for success. Overall workload was estimated at 47 hours per site. ConclusionsThis FRAM analysis provided insight into PAM from the perspective of frontline clinicians, revealing essential functions, interdependencies and variability, and the relation with guidelines. Future studies are warranted to study the potential of FRAM, such as for guiding improvements in complex systems. Show less
Vos, M.S. de; Hamming, J.F.; Marang-van de Mheen, P.J. 2021
ObjectiveIt remains unclear to what extent the morbidity and mortality conference (M&M) meets the objective of improving quality and safety of patient care. It has been suggested that M&M... Show moreObjectiveIt remains unclear to what extent the morbidity and mortality conference (M&M) meets the objective of improving quality and safety of patient care. It has been suggested that M&M may be too focused on individual performance, hampering system-level improvement. The aim of this study was to assess focus and sustainability of lessons for patient care that were derived from M&M. MethodsThis is an observational study of routinely collected data on evaluated complications and identified lessons at surgical M&M for 8 years, assessing type and recurrence of lessons and cases from which these were drawn. Semistructured interviews with clinicians were qualitatively analyzed to explore factors contributing to lesson focus and recurrence. ResultsThree hundred eighteen lessons were drawn from 10,883 evaluated complications, primarily for those that were more severe, related to surgical or other treatment, and occurring in nonemergent, lower risk cases (all P < 0.001). Most lessons targeted intraoperative (43%) rather than preoperative or postoperative care as well as specifically technical (87%) and individual-level issues (74%). There were 43 recurring lessons (14%), mostly about postoperative care (47%) and medication management (50%). Interviewed clinicians attributed the intraoperative, technical focus primarily to greater appeal and control but identified an array of factors contributing to lesson recurrence, such as typical staff turnover in teaching hospitals. ConclusionsThis study provided empirical evidence that learning at M&M has a tendency to focus on intraoperative, technical performance, with challenges to sustain lessons for more system-level issues. Morbidity and mortality conference formats need to anticipate these tendencies to ensure a wide focus for learning with lasting and wide impact. Show less
Vos, M.S. de; Hamming, J.F.; Boosman, H.; Marang-van de Mheen, P.J. 2021
ObjectivesLinkage of safety data to patient experience data may provide information to improve surgical care. This retrospective observational study aimed to assess associations between... Show moreObjectivesLinkage of safety data to patient experience data may provide information to improve surgical care. This retrospective observational study aimed to assess associations between complications, incidents, patient-reported problems, and overall patient experience. MethodsRoutinely collected data from safety reporting on complications and incidents, as well as patient-reported problems and experience on the Picker Patient Experience Questionnaire 15, covering seven experience dimensions, were linked for 4236 surgical inpatients from an academic center (April 2014-December 2015, 41% response). Associations between complication and/or incident occurrence and patient-reported problems, regarding risk of nonpositive experience (i.e., grade of 1-5 of 10), were studied using multivariable logistic regression. ResultsPatient-reported problems were associated with occurrence of complications/incidents among patients with nonpositive experiences (odds ratio [OR] = 2.8, 95% confidence interval [CI] = 1.6-4.9), but not among patients with positive experiences (OR = 1.0, 95% CI = 0.6-1.5). For each experience dimension, presence of patient-reported problems increased risk of nonpositive experience (OR range = 2.7-4.4). Patients with complications or incidents without patient-reported problems were at lower risk of a nonpositive experience than patients with neither complications/incidents nor reported problems (OR = 0.5; 95% CI = 0.3-0.9). Occurrence of complications/incidents only increased risk of nonpositive experience when patients also had problems on "continuity and transition" or "respect for patient preferences" dimensions. ConclusionsLinking safety data to patient experience data can reveal ways to optimize care. Staff seem able to ensure positive patient experiences despite complications or incidents. Increased attention should be paid to respecting patient preferences, continuity, and transition, particularly when complications or incidents occur. Show less
Aims Huntington's disease (HD) is a neurodegenerative disease with cognitive, motor and psychiatric symptoms. Toxic accumulation of misfolded mutant huntingtin protein induces mitochondrial... Show moreAims Huntington's disease (HD) is a neurodegenerative disease with cognitive, motor and psychiatric symptoms. Toxic accumulation of misfolded mutant huntingtin protein induces mitochondrial dysfunction, leading to a bioenergetic insufficiency in neuronal and muscle cells. We evaluated the safety, pharmacokinetics and pharmacodynamics of SBT-020, a novel compound to improve mitochondrial function, in a 2-part study in early stage HD patients.Methods Part 1 consisted of 7-day multiple ascending dose study to select the highest tolerable dose for Part 2, a 28-day multiple dose study. Mitochondrial function was measured in the visual cortex and calf muscle, using phosphorous magnetic resonance spectroscopy, and in circulating peripheral blood mononuclear cells.Results Treatment-emergent adverse events were mild and more present in the SBT-020 group. Injection site reactions occurred in 91% in Part 1 and 97% in Part 2. Mitochondrial function in calf muscle, peripheral blood mononuclear cells or visual cortex was not changed overall due to treatment with SBT-020. In a posthoc analysis, patients with a higher degree of mitochondrial dysfunction (below the median [ increment psi(m) < 3412 and tau PCr > 42.5 s]) showed more improvement than patients with a relatively lower level of mitochondrial dysfunction.Conclusion SBT-020 was safe at all doses, but no significant differences in any of the pharmacodynamic measurements between the treatment groups and placebo group could be demonstrated. The data suggest that the better than expected mitochondrial function in our patient population at baseline might explain the lack of effect of SBT-020. Show less
Boer, M.C. den; Martherus, T.; Houtlosser, M.; Root, L.; Witlox, R.S.G.M.; Pas, A.B. te 2020
Video and physiological parameter recording of neonatal stabilization was implemented at the Neonatal Intensive Care Unit (NICU) of the Leiden University Medical Center. In order to improve... Show moreVideo and physiological parameter recording of neonatal stabilization was implemented at the Neonatal Intensive Care Unit (NICU) of the Leiden University Medical Center. In order to improve documentation and the quality of care provided during neonatal transition, we implemented weekly plenary audits reviewing recordings of neonatal stabilization in 2014. In audits, provided care is reviewed, discussing, among others, mask technique, compliance to the prevailing local guideline, and clinical decision making and alternative treatment options. In this perspective, we argue that auditing neonatal stabilization is a valuable tool to improve patient safety and the quality of care provided during neonatal stabilization. We, therefore, report lessons learned and areas for improvement that could be identified and addressed during audits conducted at our NICU. Important areas for improvement were guideline compliance, documentation, the usage of medical devices, the conduct of delivery room studies, and clinical decision making. By reporting our experiences, we hope to encourage other NICUs to also implement regular audit meetings, fitting to their improvement needs. Show less
Boer, I. de; MaassenVanDenBrink, A.; Terwindt, G.M. 2020
Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is an inherited small vessel disease characterised by recurrent ischemic stroke, cognitive... Show moreCerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is an inherited small vessel disease characterised by recurrent ischemic stroke, cognitive decline progressing to dementia, psychiatric disturbances and apathy. More than half of mutation carriers suffer from migraine, most often migraine with aura. Recently, a CADASIL patient was treated with a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor. Monoclonal antibodies targeting the CGRP system have been demonstrated to be safe, well tolerated, and effective in reducing migraine attacks. There is, however, abundant evidence that CGRP is important in maintaining cardiovascular homeostasis under (patho)physiological conditions. CGRP may act as a vasodilatory safeguard during cerebral and cardiac ischemia and blockage of the system could, therefore, potentially worsen ischemic events. Therefore, we caution against treating patients with small vessel diseases, such as the monogenic disorder CADASIL, with these drugs until relevant safety data and long term follow up results are available. Alternative preventive migraine treatments in CADASIL may be acetazolamide, sodium valproate, lamotrigine, topiramate, verapamil, or flunarizine. Show less
Beaney, A.M.; Brun, P. le; Ravera, S.; Scheepers, H. 2020
This article focuses on the reconstitution of parenteral medicines and the work that has been carried out at the European level to improve patient safety. Reconstitution may occur in a clinical... Show moreThis article focuses on the reconstitution of parenteral medicines and the work that has been carried out at the European level to improve patient safety. Reconstitution may occur in a clinical area, for example, ward, theatre and so on, or within pharmacy. The quality of reconstituted medicines should ideally be the same, regardless of where reconstitution takes place. However, in practice, risks are greater when reconstitution is carried out in clinical areas. Although ideally all reconstitutions should be carried out within pharmacy aseptic units, capacity is generally not available to allow this, so a risk assessment approach must be taken to enable the healthcare establishment to decide which products must be reconstituted in pharmacy and which, with appropriate safeguards, can be reconstituted in clinical areas. Although guidance on reconstitution has been established in some countries, this is not the case across much of Europe. The Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (Council of Europe) (hereafter: Committee of Experts) has undertaken work to develop quality and safety standards for reconstitution in the different locations within healthcare establishments, taking a risk-based approach. In June 2016, the Committee of Ministers of the Council of Europe adopted Resolution CM/Res(2016)2 on good reconstitution practices in healthcare establishments for medicinal products for parenteral use. Drafted by the Committee of Experts, the Resolution recommends implementation measures for best practices for the reconstitution of injectable medicines for administration to patients. This article summarises the rationale behind the Resolution, its drafting process and main chapters. There is no justification for patient safety with respect to reconstituted medicines to be variable across the Member States of the Council of Europe. Implementation of Resolution CM/Res(2016)2 will enable risk reduction in healthcare establishments and is a major contribution to patient safety from injectable medicines at the international level. Show less
Background: Surgical skills and decision making are influenced by alertness, reaction time, eye-hand coordination, and concentration. Night shift might impair these functions but it is unclear to... Show moreBackground: Surgical skills and decision making are influenced by alertness, reaction time, eye-hand coordination, and concentration. Night shift might impair these functions but it is unclear to what extent. The aim of this study was to investigate whether a night shift routinely impairs the surgeon's fitness to perform and whether this reaches a critical limit as compared to relevant frames of reference.Methods: Consultants (n = 59) and residents (n = 103) conducted fitness to perform measurements at precall, postcall, and noncall moments. This validated self-test consists of an adaptive tracker that is able to objectively measure alertness, reaction time, concentration, and eye-hand coordination, and multiple visual analog scales to subjectively score alertness. Results are compared to sociolegal (ethanol) and professional (operative skills) frames of reference that refer to a decrease under the influence of 0.06% ethanol.Results: Residents spent 1.7 call hours asleep on average as compared to 5.4 for consultants. Subjective alertness decreased in residents after night shifts (-13, P < 0.001) but not in consultants (-1.2, P = NS). The overnight difference in tracker score was -1.17 (P < 0.001) for residents and 0.46 (P = NS) for surgeons. Postcall subjective alertness only correlated to objective alertness in consultants. For residents, hours slept on-call correlated to objective alertness. For consultants, subsequent night calls significantly correlated to objective alertness, with the third subsequent call related to performance below the reference.Conclusions: Consultants remain fit to perform after night call, but subsequent calls may compromise clinical activities. This study provides insight and awareness of individual performance with clear frames of reference. Show less
