Haemangiomas are common benign tumours that are generally detected within the skin, mucosal surfaces and soft tissues. However, intranodal haemangiomas are extremely rare and are among the benign primary vascular abnormalities of the lymph nodes that include lymphangioma, haemangioendothelioma, angiomyomatous hamartoma and haemangiomas. In this case report, we present the imaging and pathological findings of an intranodal haemangioma in the pancreatic head simulating a pancreatic neuroendocrine tumour. To the best of our knowledge, this is the first report of an intranodal haemangioma in this location.
Limited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada.
We performed a 2-stage medical record review at 8 academic pediatric centres and 14 community hospitals in Canada. We reviewed charts from patients admitted from April 2008 through March 2009, evenly distributed across 4 age groups (0 to 28 d; 29 to 365 d; > 1 to 5 yr and > 5 to 18 yr). In stage 1, nurses and health records personnel who had received training in the use of the Canadian Paediatric Trigger Tool reviewed medical records to detect triggers for possible adverse events. In stage 2, physicians reviewed the charts identified as having triggers and described the adverse events.
A total of 3669 children were admitted to hospital during the study period. The weighted rate of adverse events was 9.2%. Adverse events were more frequent in academic pediatric centres than in community hospitals (adjusted odds ratio [OR] 2.98, 95% confidence interval [CI] 1.65–5.39). The incidence of preventable adverse events was not significantly different between types of hospital, but nonpreventable adverse events were more common in academic pediatric centres (adjusted OR 4.39, 95% CI 2.08–9.27). Surgical events predominated overall and occurred more frequently in academic pediatric centres than in community hospitals (37.2% v. 21.5%, relative risk [RR] 1.7, 95% CI 1.0–3.1), whereas events associated with diagnostic errors were significantly less frequent (11.1% v. 23.1%, RR 0.5, 95% CI 0.2–0.9).
More children have adverse events in academic pediatric centres than in community hospitals; however, adverse events in the former are less likely to be preventable. There are many opportunities to reduce harm affecting children in hospital in Canada, particularly related to surgery, intensive care and diagnostic error.
Children born to women with epilepsy (WWE), exposed in utero to levetiracetam (LEV, n = 51), were assessed for early cognitive development and compared to children exposed to sodium valproate in utero (VPA, n = 44) and a group of children representative of the general population (n = 97).
Children were recruited prospectively from 2 cohorts in the United Kingdom and assessed using the Griffiths Mental Development Scale (1996), aged <24 months. Information regarding maternal demographics were collected and controlled for. This is an observational study with researchers not involved in the clinical management of the WWE.
On overall developmental ability, children exposed to LEV obtained higher developmental scores when compared to children exposed to VPA (p < 0.001). When compared, children exposed to LEV did not differ from control children (p = 0.62) on overall development. Eight percent of children exposed to LEV in utero fell within the below average range (DQ score of <84), compared with 40% of children exposed to VPA. After controlling for maternal epilepsy and demographic factors using linear regression analysis, exposure to LEV in utero was not associated with outcome (p = 0.67). Conversely, when compared with VPA exposure, LEV exposure was associated with higher scores for the overall developmental quotient (p < 0.001).
Children exposed to LEV in utero are not at an increased risk of delayed early cognitive development under the age of 24 months. LEV may therefore be a preferable drug choice, where appropriate, for WWE prior to and of childbearing age.
Breastfeeding is known to have beneficial effects, but there is concern that breastfeeding during antiepileptic drug (AED) therapy may be harmful to cognitive development. Animal and human studies have demonstrated that some AEDs can adversely affect the immature brain. However, no investigation has examined effects of breastfeeding during AED therapy on subsequent cognitive abilities in children.
The Neurodevelopmental Effects of Antiepileptic Drugs Study is an ongoing prospective multicenter observational investigation of long-term effects of in utero AED exposure on cognition. Between 1999 and 2004, we enrolled pregnant women with epilepsy who were taking a single AED (carbamazepine, lamotrigine, phenytoin, or valproate). We recently reported on differential AED effects on age 3 year cognitive outcomes. In this report, we focus on the effects of breastfeeding during AED therapy on age 3 cognitive outcomes in 199 children.
A total of 42% of children were breastfed. IQs for breastfed children did not differ from nonbreastfed children for all AEDs combined and for each of the 4 individual AED groups. Mean adjusted IQ scores (95% confidence intervals) across all AEDs were breastfed = 99 (96–103) and nonbreastfed = 98 (95–101). Power was 95% to detect a half SD IQ effect in the combined AED analysis, but was inadequate within groups.
This preliminary analysis fails to demonstrate deleterious effects of breastfeeding during AED therapy on cognitive outcomes in children previously exposed in utero. However, caution is advised due to study limitations. Additional research is needed to confirm this observation and extend investigations to other AEDs and polytherapy.
= antiepileptic drug;
= National Adult Reading Test;
= Neurodevelopmental Effects of Antiepileptic Drugs;
= Test of Nonverbal Intelligence;
= Wechsler Abbreviated Scale of Intelligence.
Hearing loss is often caused by death of the mechanosensory hair cells of the inner ear. Hair cells are susceptible to death caused by aging, noise trauma, and ototoxic drugs, including the aminoglycoside antibiotics and the antineoplastic agent cisplatin. Ototoxic drugs result in permanent hearing loss for over 500 000 Americans annually. We showed previously that induction of heat shock proteins (HSPs) inhibits both aminoglycoside- and cisplatin-induced hair cell death in whole-organ cultures of utricles from adult mice. In order to begin to translate these findings into a clinical therapy aimed at inhibiting ototoxic drug-induced hearing loss, we have now examined a pharmacological HSP inducer, celastrol. Celastrol induced upregulation of HSPs in utricles, and it provided significant protection against aminoglycoside-induced hair cell death in vitro and in vivo. Moreover, celastrol inhibited hearing loss in mice receiving systemic aminoglycoside treatment. Our data indicate that the major heat shock transcription factor HSF-1 is not required for celastrol-mediated protection. HSP32 (also called heme oxygenase-1, HO-1) is the primary mediator of the protective effect of celastrol. HSP32/HO-1 inhibits pro-apoptotic c-Jun N-terminal kinase (JNK) activation and hair cell death. Taken together, our data indicate that celastrol inhibits aminoglycoside ototoxicity via HSP32/HO-1 induction.
ototoxicity; hair cell; celastrol; heat shock protein; utricle; cochlea; hearing loss
Adverse effects (AEs) are a major concern when starting antiepileptic drug (AED) treatment. This study quantified the extent to which AE reporting in people with new-onset seizures started on AEDs is attributable to the medication per se, and investigated variables contributing to AE reporting.
We pooled data from 2 large prospective studies, the Multicenter Study of Early Epilepsy and Single Seizures and the Northern Manhattan Study of incident unprovoked seizures, and compared adverse event profile (AEP) total and factor scores between adult cases prescribed AEDs for new-onset seizures and untreated controls, adjusting for several demographic and clinical variables. Differences in AEP scores were also tested across different AED monotherapies and controls, and between cases and controls grouped by number of seizures.
A total of 212 cases and 206 controls were identified. Most cases (94.2%) were taking low AED doses. AEP scores did not differ significantly between the 2 groups. Depression, female gender, symptomatic etiology, younger seizure onset age, ≥2 seizures, and history of febrile seizures were associated with higher AEP scores. There were no significant differences in AEP scores across different monotherapies and controls. AEP scores increased in both cases and controls with increasing number of seizures, the increment being more pronounced in cases.
When AED treatment is started at low doses following new-onset seizures, AE reporting does not differ from untreated individuals. Targeting specific factors affecting AE reporting could lead to improved tolerability of epilepsy treatment.
Efforts to improve the implementation of effective practice and to speed up improvements in quality and patient safety continue to pose challenges for researchers and policy makers. Organisational research, and, in particular, case studies of quality improvement, offer methods to improve understanding of the role of organisational and microsystem contexts for improving care and the development of theories which might guide improvement strategies.
This paper reviews examples of such research and details the methodological issues in constructing and analysing case studies. Case study research typically collects a wide array of data from interviews, documents and other sources.
Advances in methods for coding and analysing these data are improving the quality of reports from these studies.
Quality improvement; case study; qualitative research; healthcare quality improvement; research
to determine the influence of epilepsy and its treatment on pregnancy and its outcome.
controlled, observational study.
National Health Service maternity hospitals in Liverpool and Manchester regions.
277 women with epilepsy (WWE) and 315 control women.
WWE were recruited from antenatal clinics. Controls were matched for age and parity but not gestational age. Information was obtained by interview and from clinical records. Main Outcome Measures: obstetric complications, mode of delivery, condition of newborn.
Distribution of epilepsy syndromes was similar to previous surveys. Most WWE (67%) received monotherapy with carbamazepine, sodium valproate or lamotrigine. Half WWE had no seizures during pregnancy but 34% had tonic clonic seizures. Seizure related injuries were infrequent. Pregnancies with obstetric complications were increased in women with treated epilepsy (WWTE 45%, controls 33%; p = 0.01). Most had normal vaginal delivery (WWTE 63%, controls 61%; p = 0.65). Low birth weight was not increased (WWTE 6.2%, controls 5.2%; p = 0.69). There were more major congenital malformations (MCM) (WWTE 6.6%, controls 2.1%; p = 0.02) and fetal/infant deaths (WWTE 2.2%, controls 0.3%; p = 0.09). Amongst monotherapies MCM prevalence was highest with valproate (11.3%; p = 0.005). Lamotrigine (5.4%; p = 0.23) and carbamazepine (3.0%; p = 0.65) were closer to controls (2.1%). There was no association between MCM and dose of folic acid preconception.
MCM were more prevalent in the babies of WWTE particularly amongst those receiving sodium valproate.
Epilepsy; Antiepileptic drugs; Pregnancy outcome; Teratogenicity
Reduced function of the N-methyl-D-aspartate receptor (NMDAR) has been implicated in the pathophysiology of schizophrenia. The NMDAR contains a glycine binding site in its NR1 subunit that may be a useful target for the treatment of schizophrenia. In this study, we assessed the therapeutic potential of long-term increases in the brain levels of the endogenous NMDAR glycine site agonist D-serine, through the genetic inactivation of its catabolic enzyme D-amino acid oxidase (DAO) in mice. The effects of eliminating DAO function were investigated in mice that display schizophrenia-related behavioral deficits due to a mutation (Grin1D481N) in the NR1 subunit that results in a reduction in NMDAR glycine affinity. Grin1D481N mice show deficits in sociability, prolonged latent inhibition, enhanced startle reactivity, and impaired spatial memory. The hypofunctional Dao1G181R mutation elevated brain levels of D-serine, but alone it did not affect performance in the behavioral measures. Compared to animals with only the Grin1D481N mutation, mice with both the Dao1G181R and Grin1D481N mutations displayed an improvement in social approach and spatial memory retention, as well as a reversal of abnormally persistent latent inhibition and a partial normalization of startle responses. Thus, an increased level of D-serine resulting from decreased catalysis corrected the performance of mice with deficient NMDAR glycine site activation in behavioral tasks relevant to the negative and cognitive symptoms of schizophrenia. Diminished DAO activity and elevations in D-serine may serve as an effective therapeutic intervention for the treatment of psychiatric symptoms.
NMDA receptor; D-serine; D-amino acid oxidase; genetic mouse model; schizophrenia; social behaviors; latent inhibition; spatial memory
To describe the process of developing and validating the Canadian Association of Paediatric Health Centres Trigger Tool (CPTT).
Five existing trigger tools were consolidated with duplicate triggers eliminated. After a risk analysis and modified Delphi process, the tool was reduced from 94 to 47 triggers. Feasibility of use was tested, reviewing 40 charts in three hospitals. For validation, charts were randomly selected across four age groups, half medical/half surgical diagnoses, from six paediatric academic health sciences centres. 591 charts were reviewed by six nurses (for triggers and adverse events (AEs)) and three physicians (for AEs only). The incidence of trigger- and AE-positive charts was documented, and the sensitivity and specificity of the tool to identify charts with AEs were determined. Identification of AEs by nurses and physicians was compared. The positive predictive value (PPV) of each trigger was calculated and the ratio of false- to true-positive AE predictors analysed for each trigger.
Nurses rated the CPTT easy to use and identified triggers in 61.1% (361/591; 95% CI 57.2 to 65.0) of patient charts; physicians identified AEs in 15.1% (89/ 591, 95% CI 0.23 to 0.43). Over a third of patients with AEs were neonates. The sensitivity and specificity were 0.88 and 0.44, respectively. Nurse and physician AE assessments correlated poorly. The PPV for each trigger ranged from 0 to 88.3%. Triggers with a false/true-positive ratio of >0.7 were eliminated, resulting in the final 35-trigger CPTT.
The CPTT is the first validated, comprehensive trigger tool available to detect AEs in children hospitalised in acute care facilities.
Trigger; adverse event; harm; patient safety; research
Herbal products are readily available over the counter in health food stores and are often perceived to be without risk. The current Canadian adverse event reporting system suffers from severe underreporting, resulting in a scarcity of safety data on herbal products. Twelve health food store personnel in the Greater Toronto Area were interviewed about their responses to herbal product–related adverse reactions. They generally fostered customer loyalty by offering generous return policies, which included collecting contact information to be sent to the manufacturers with the returned product. Thus, despite the public's lack of knowledge about the formal reporting system, adverse reaction information was directed to manufacturers whenever it resulted in a product return. The relationship between health food stores, industry and Health Canada provides a new opportunity to facilitate adverse event reporting. Additional information could be collected during the return process, and educational initiatives could be implemented to augment current post-market surveillance procedures for herbal products.
Natural health products (NHPs), such as herbal medicines and vitamins, are widely available over-the-counter and are often purchased by consumers without advice from a healthcare provider. This study examined how consumers respond when they believe they have experienced NHP-related adverse drug reactions (ADRs) in order to determine how to improve current safety monitoring strategies.
Qualitative semi-structured interviews were conducted with twelve consumers who had experienced a self-identified NHP-related ADR. Key emergent themes were identified and coded using content analysis techniques.
Consumers were generally not comfortable enough with their conventional health care providers to discuss their NHP-related ADRs. Consumers reported being more comfortable discussing NHP-related ADRs with personnel from health food stores, friends or family with whom they had developed trusted relationships. No one reported their suspected ADR to Health Canada and most did not know this was possible.
Consumers generally did not report their suspected NHP-related ADRs to healthcare providers or to Health Canada. Passive reporting systems for collecting information on NHP-related ADRs cannot be effective if consumers who experience NHP-related ADRs do not report their experiences. Healthcare providers, health food store personnel, manufacturers and other stakeholders also need to take responsibility for reporting ADRs in order to improve current pharmacovigilance of NHPs.
Better reporting of quality improvement efforts could assist in the design of effectiveness research
quality improvement; evidence; guidelines; research methods
This paper explores the factors that influence the persistence of unsafe practice in an interprofessional team setting in health care, towards the development of a descriptive theoretical model for analyzing problematic practice routines. Using data collected during a mixed method interview study of 28 members of an operating room team, participants' approaches to unsafe practice were analyzed using the following three theoretical models from organizational and cognitive psychology: Reason's theory of “vulnerable system syndrome”, Tucker and Edmondson's concept of first and second order problem solving, and Amalberti's model of practice migration. These three theoretical approaches provide a critical insight into key trends in the interview data, including team members' definition of error as the breaching of standards of practice, nurses' sense of scope of practice as a constraint on their reporting behaviours, and participants' reports of the forces influencing tacit agreements to work around safety regulations. However, the relational factors underlying unsafe practice routines are poorly accounted for in these theoretical approaches. Incorporating an additional theoretical construct such as “relational coordination” to account for the emotional human features of team practice would provide a more comprehensive theoretical approach for use in exploring unsafe practice routines and the forces that sustain them in healthcare team settings.
patient safety; organisational factors; teamwork
Objective To develop a conceptual framework of the influences on
medical trainees’ decisions regarding requests for clinical support from a
Design Phase 1: members of teaching teams in internal and emergency
medicine were observed during regular clinical activities (216 hours) and
subsequently completed brief interviews. Phase 2: 36 in depth interviews were
conducted using videotaped vignettes to probe tacit influences on decisions to
request support. Data collection and analysis used grounded theory methods.
Setting Three teaching hospitals in an urban setting in Canada.
Participants 124 members of teaching teams on general internal
medicine wards and in the emergency department, comprising 31 attending
physicians, 57 junior and senior residents, 28 medical students, and eight
nurses. Purposeful sampling to saturation was conducted.
Results Trainees’ decisions about whether or not to seek clinical
support were influenced by three issues: the clinical question (clinical
importance, scope of practice), supervisor factors (availability,
approachability), and trainee factors (skill, desire for independence,
evaluation). Trainees perceived that requesting frequent/inappropriate support
threatened their credibility and used rhetorical strategies to preserve
credibility. These strategies included building a case for the importance of
requests, saving requests for opportune moments, making a plan before requesting
support, and targeting requests to specific team members.
Conclusions Trainees consider not only clinical implications but
also professional credibility when requesting support from clinical supervisors.
Exposing the complexity of this process provides the opportunity to make changes
to training programmes to promote timely supervision and provides a framework
for further exploration of the impact of clinical training on quality of care of
Effective hospital governance depends on proactive board leadership to minimize risk.
To survey hospital board chairs about governance practices, particularly with respect to approval processes for oversight of management preparedness for unforeseen emergencies.
A 2004 survey of hospital managers initially suggested greater board leadership in risk management as a desired strategic priority for Ontario's acute care hospitals. Our literature review and panel process defined 34 best practices in board governance, including two practices explicitly addressing the board's role in preparing for risk.
Our findings revealed that some boards may not be actively engaged in ensuring that adequate processes are in place to protect against risk. More than one-quarter (n=28, 26.9%) of board chairs reported that they had not approved a management plan to address emergencies. Thirty respondents (28.8%) said they had not approved a process to identify, manage and minimize risks to the hospital's sustainability. Forty-seven respondents (45.2%) said they had not approved both of these two processes. A significant association emerged between boards that had approved both risk preparation strategies and boards that had implemented six key governance practices relating to accountability for leadership and stakeholder communication.
Background: Pilot studies of complex interventions such as a team checklist are an essential precursor to evaluating how these interventions affect quality and safety of care. We conducted a pilot implementation of a preoperative team communication checklist. The objectives of the study were to assess the feasibility of the checklist (that is, team members' willingness and ability to incorporate it into their work processes); to describe how the checklist tool was used by operating room (OR) teams; and to describe perceived functions of the checklist discussions.
Methods: A checklist prototype was developed and OR team members were asked to implement it before 18 surgical procedures. A research assistant was present to prompt the participants, if necessary, to initiate each checklist discussion. Trained observers recorded ethnographic field notes and 11 brief feedback interviews were conducted. Observation and interview data were analyzed for trends.
Results: The checklist was implemented by the OR team in all 18 study cases. The rate of team participation was 100% (33 vascular surgery team members). The checklist discussions lasted 1–6 minutes (mean 3.5) and most commonly took place in the OR before the patient's arrival. Perceived functions of the checklist discussions included provision of detailed case related information, confirmation of details, articulation of concerns or ambiguities, team building, education, and decision making. Participants consistently valued the checklist discussions. The most significant barrier to undertaking the team checklist was variability in team members' preoperative workflow patterns, which sometimes presented a challenge to bringing the entire team together.
Conclusions: The preoperative team checklist shows promise as a feasible and efficient tool that promotes information exchange and team cohesion. Further research is needed to determine the sustainability and generalizability of the checklist intervention, to fully integrate the checklist routine into workflow patterns, and to measure its impact on patient safety.
Concern about the link between clinical supervision and safe, quality health care has led to widespread increases in the supervision of medical trainees. The effects of increased supervision on patient care and trainee education are not known, primarily because the current multifacted and poorly operationalized concept of clinical supervision limits the potential for evaluation.
To develop a conceptual model of clinical supervision to inform and guide policy and research.
Design, Setting, and Participants
Observational fieldwork and interviews were conducted in the Emergency Department and General Internal Medicine in-patient teaching wards of two academic health sciences centers associated with an urban Canadian medical school. Members of 12 Internal Medicine and Emergency Medicine teaching teams (n = 88) were observed during regular clinical activities (216 hours). Sixty-five participants (12 physicians, 28 residents, 17 medical students, 8 nurses) also completed interviews about supervision. Field notes and interview transcripts were analyzed for emergent themes using grounded theory methodology.
The term “clinical oversight” was developed to describe patient care activities performed by supervisors to ensure quality of care. “Routine oversight” (preplanned monitoring of trainees’ clinical work) can expose supervisors to concerns that trigger “responsive oversight” (a double-check or elaboration of trainees’ clinical work). Supervisors sometimes engage in “backstage oversight” (oversight of which the trainee is not directly aware). When supervisors encounter a situation that exceeds a trainee’s competence, they move beyond clinical oversight to “direct patient care”.
This study elaborates a typology of clinical oversight activities including routine, responsive, and backstage oversight. This new typology provides a framework for clinical supervision policy and for research to evaluate the relationship between supervision and safety.
qualitative research; grounded theory methodology; medical education; professionalism; patient safety
Thalamocortical afferents in the visual cortex of the adult sable ferret are segregated into eye-specific ocular dominance bands. The development of ocular dominance bands was studied by transneuronal labeling of the visual cortices of ferret kits between the ages of postnatal day 28 (P28) and P81 after intravitreous injections of either tritiated proline or wheat germ agglutinin-horseradish peroxidase. Laminar specificity was evident in the youngest animals studied and was similar to that in the adult by P50. In P28 and P30 ferret kits, no modulation reminiscent of ocular dominance bands was detectable in the pattern of labeling along layer IV. By P37 a slight fluctuation in the density of labeling in layer IV was evident in serial reconstructions. By P50, the amplitude of modulation had increased considerably but the pattern of ocular dominance bands did not yet appear mature. The pattern and degree of modulation of the ocular dominance bands resembled that in adult animals by P63. Flat mounts of cortex and serial reconstructions of layer IV revealed an unusual arrangement of inputs serving the two eyes in the region rostral to the periodic ocular dominance bands. In this region, inputs serving the contralateral eye were commonly fused along a mediolateral axis, rostral to which were large and sometimes fused patches of ipsilateral input.
area 17; transneuronal; cortical columns; thalamocortical; functional architecture; critical period
The Pidd (p53-induced protein with death domain) gene was shown to be induced by the tumour suppressor p53 and to mediate p53-dependent apoptosis in mouse and human cells, through interactions with components of both the mitochondrial and the death receptor signalling pathways. To study the role of Pidd in clinical tumours, we measured its expression by quantitative reverse transcription-PCR in microdissected oral squamous cell carcinomas (OSCC) with and without p53 mutation. Tumour cell apoptosis was assessed by in situ terminal deoxynucleotidyl transferase-mediated dUTP nick-end labelling. Tumour proliferation was assessed by immunohistochemical staining for the Ki-67 antigen. We found a wide range of Pidd expression among OSCC. Statistical analysis revealed an association between Pidd expression and apoptotic index (Mann–Whitney test, P<0.001), consistent with a role of Pidd in apoptosis in this tumour type. Furthermore, we showed a positive correlation between apoptotic index and proliferative index that has not been previously described for OSCC. There was no correlation between Pidd expression and the p53 mutation status of these tumours, suggesting that Pidd expression may be regulated by p53-independent mechanisms. Further characterisation of these molecular defects in the control of proliferation and apoptosis should help in developing treatments that target OSCC according to their biological properties.
Pidd; apoptosis; p53; oral; carcinoma
Objectives: To determine the prevalence of cognitive delay and possible associated dysmorphic features in children exposed to antiepileptic drugs (AEDs) in utero.
Design: Retrospective study of children born to mothers with epilepsy.
Setting: Regional epilepsy clinics in Liverpool and Manchester, UK.
Participants: Children aged between 6 months and 16 years born to mothers with epilepsy.
Main outcome measures: Structured interviews, hospital records, clinical examination, and psychometric tests (Wechsler) were used to assess exposure and intelligence quotient (IQ). Blinded assessment of photographs was used to score children with characteristic dysmorphic features.
Results: A total of 249 children aged 6 and over were studied: 41 were exposed to sodium valproate, 52 to carbamazepine, 21 to phenytoin, 49 to polytherapy, and 80 were unexposed. Mean verbal IQ was significantly lower in the valproate group compared to unexposed and other monotherapy groups. Multiple regression analysis showed that both valproate exposure and frequent tonic-clonic seizures in pregnancy were significantly associated with a lower verbal IQ despite adjusting for other confounding factors. There was a significant negative correlation between dysmorphic features and verbal IQ in children exposed to valproate.
Conclusions: This study identifies valproate as a drug carrying potential risks for developmental delay and cognitive impairment and is the first to suggest that frequent tonic-clonic seizures have a similar effect. Our results need to be interpreted with caution given their retrospective nature. Women with epilepsy need careful counselling about individual risk benefit of AED treatment before pregnancy.
Background: Ineffective team communication is frequently at the root of medical error. The objective of this study was to describe the characteristics of communication failures in the operating room (OR) and to classify their effects. This study was part of a larger project to develop a team checklist to improve communication in the OR.
Methods: Trained observers recorded 90 hours of observation during 48 surgical procedures. Ninety four team members participated from anesthesia (16 staff, 6 fellows, 3 residents), surgery (14 staff, 8 fellows, 13 residents, 3 clerks), and nursing (31 staff). Field notes recording procedurally relevant communication events were analysed using a framework which considered the content, audience, purpose, and occasion of a communication exchange. A communication failure was defined as an event that was flawed in one or more of these dimensions.
Results: 421 communication events were noted, of which 129 were categorized as communication failures. Failure types included "occasion" (45.7% of instances) where timing was poor; "content" (35.7%) where information was missing or inaccurate, "purpose" (24.0%) where issues were not resolved, and "audience" (20.9%) where key individuals were excluded. 36.4% of failures resulted in visible effects on system processes including inefficiency, team tension, resource waste, workaround, delay, patient inconvenience and procedural error.
Conclusion: Communication failures in the OR exhibited a common set of problems. They occurred in approximately 30% of team exchanges and a third of these resulted in effects which jeopardized patient safety by increasing cognitive load, interrupting routine, and increasing tension in the OR.
Pregnancy outcomes following in utero exposure to antiepileptic drugs (AEDs) are uncertain, limiting an evidenced-based approach.
To determine if fetal outcomes vary as a function of different in utero AED exposures.
This ongoing prospective observational study across 25 epilepsy centers in the USA and UK enrolled pregnant women with epilepsy from October 1999 to February 2004 to determine if differential long-term cognitive and behavioral neurodevelopmental effects exist across the four most commonly used AEDs. This initial report focuses on the incidence of serious adverse outcomes including major congenital malformations (which could be attributable to AEDs) or fetal death. A total of 333 mother/child pairs were analyzed for monotherapy exposures: carbamazepine (n = 110), lamotrigine (n = 98), phenytoin (n = 56), and valproate (n = 69).
Response frequencies of pregnancies resulting in serious adverse outcomes for each AED were as follows: carbamazepine 8.2%, lamotrigine 1.0%, phenytoin 10.7%, and valproate 20.3%. Distribution of serious adverse outcomes differed significantly across AEDs and was not explained by factors other than in utero AED exposure. Valproate exhibited a dose-dependent effect.
More adverse outcomes were observed in pregnancies with in utero valproate exposure vs the other antiepileptic drugs (AEDs). These results combined with several recent studies provide strong evidence that valproate poses the highest risk to the fetus. For women who fail other AEDs and require valproate, the dose should be limited if possible.
The Canadian Adverse Events Study was the first national study of adverse events in Canadian hospitals. Learning from the controversy surrounding similar studies in other countries, the team engaged in extensive knowledge translation activities throughout the life of the project. Using meetings, Web-based communication and other tools, the team successfully prepared most Canadian stakeholders for the study’s release, allowing them to develop anticipatory patient safety initiatives. However, upon publication of the study, the policy spotlight quickly shifted to other issues, and the long-term commitment needed to create safer healthcare is still uncertain.