Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data.

AIMS: Medication non-adherence is a type of adverse drug event that can lead to untreated and exacerbated chronic illness, and that drives healthcare utilization. Research using medication claims data has attempted to identify instances of medication non-adherence using the proportion of days covered or by examining gaps between medication refills. We sought to validate these measures compared to a gold standard diagnosis of non-adherence made in hospital. METHODS: This was a retrospective analysis of adverse drug events diagnosed during three prospective cohorts in British Columbia between 2008 and 2015 (n = 976). We linked prospectively identified adverse drug events to medication claims data to examine the sensitivity and specificity of typical non-adherence measures. RESULTS: The sensitivity of the non-adherence measures ranged from 22.4% to 37.5%, with a proportion of days covered threshold of 95% performing the best; the non-persistence measures had sensitivities ranging from 10.4% to 58.3%. While a 7-day gap was most sensitive, it classified 61.2% of the sample as non-adherent, whereas only 19.6% were diagnosed as such in hospital. CONCLUSIONS: The methods used to identify non-adherence in administrative databases are not accurate when compared to a gold standard diagnosis by healthcare providers. Research that has relied on administrative data to identify non-adherent patients both underestimates the magnitude of the problem and may label patients as non-adherent who were in fact adherent.

Validating use of diagnostic codes in Canadian administrative data for identification of adverse drug events.

AIMS: While diagnostic codes from administrative health data might be a valuable source to identify adverse drug events (ADEs), their ability to identify unintended harms remains unclear. We validated claims-based diagnosis codes for ADEs based on events identified in a prospective cohort study and assessed whether key attributes predicted their documentation in administrative data. METHODS: This was a retrospective analysis of 3 prospective cohorts in British Columbia, from 2008 to 2015 (n = 13 969). We linked prospectively identified ADEs to administrative insurance data to examine the sensitivity and specificity of different diagnostic code schemes. We used logistic regression to assess which key attributes (e.g., type of event, symptoms and culprit medications) were associated with better documentation of ADEs in administrative data. RESULTS: Among 1178 diagnosed events, the sensitivity of the diagnostic codes in administrative data ranged from 3.4 to 52.6%, depending on the database and codes used. We found that documentation was worse for certain types of ADEs (dose-related: odds ratio [OR]: 0.32, 95% confidence interval [CI]: 0.15, 0.69; nonadherence events (OR: 0.35, 95% CI: 0.20, 0.62), and better for those experiencing arrhythmias (OR: 4.19, 95% CI: 0.96, 18.28). CONCLUSION: ADEs were not well documented in administrative data. Alternative methods should be explored to capture ADEs for health research.

Re-Exposure to Culprit Medication Following Adverse Drug Event Diagnosis in Canadian Emergency Department Patients: A Cohort Study.

PURPOSE: The magnitude of repeat exposures to culprit medications after hospital discharge is not well studied. We combined prospective cohort data with administrative health data to understand the frequency of repeat exposures to culprit medications after discharge and the risk factors for their occurrence. METHODS: This was a retrospective analysis of three prospective cohorts of patients who presented to the hospital with an adverse drug event in British Columbia, from 2008 to 2015 (n = 849). We linked prospectively identified adverse drug events to administrative data to examine patterns of redispensing of culprit medications. We used Cox regression to assess risk factors for re-exposure, and conducted subgroup analyses for essential vs. nonessential medications. RESULTS: Among 849 diagnosed adverse drug events, 45.2% had subsequent culprit medication redispensing within a year of hospital discharge. The factors associated with re-exposures included atrial fibrillation, adverse drug event type (e.g. adverse reaction), culprit medication type, and longer historical duration of medication use. CONCLUSIONS: Re-exposures to culprit medications occurred in almost half of the adverse drug events diagnosed in emergency departments. Many of these were appropriate re-exposures to essential medications for indications in which the risk of uncontrolled disease likely outweighed the risk of a repeat adverse event. More research is needed to understand re-exposures to nonessential medications or medications with safer alternatives.

Characteristics and outcomes of patients with COVID-19 who return to the emergency department: a multicentre observational study by the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN).

OBJECTIVE: Unplanned return emergency department (ED) visits can reflect clinical deterioration or unmet need from the original visit. We determined the characteristics and outcomes of patients with COVID-19 who return to the ED for COVID-19-related revisits. METHODS: This retrospective observational study used data for all adult patients visiting 47 Canadian EDs with COVID-19 between 1 March 2020 and 31 March 2022. Multivariable logistic regression assessed the characteristics associated with having a no return visit (SV=single visit group) versus at least one return visit (MV=return visit group) after being discharged alive at the first ED visit. RESULTS: 39 809 patients with COVID-19 had 44 862 COVID-19-related ED visits: 35 468 patients (89%) had one visit (SV group) and 4341 (11%) returned to the ED (MV group) within 30 days (mean 2.2, SD=0.5 ED visit). 40% of SV patients and 16% of MV patients were admitted at their first visit, and 41% of MV patients not admitted at their first ED visit were admitted on their second visit. In the MV group, the median time to return was 4 days, 49% returned within 72 hours. In multivariable modelling, a repeat visit was associated with a variety of factors including older age (OR=1.25 per 10 years, 95% CI (1.22 to 1.28)), pregnancy (1.86 (1.46 to 2.36)) and presence of comorbidities (eg, 1.72 (1.40 to 2.10) for cancer, 2.01 (1.52 to 2.66) for obesity, 2.18 (1.42 to 3.36) for organ transplant), current/prior substance use, higher temperature or WHO severe disease (1.41 (1.29 to 1.54)). Return was less likely for females (0.82 (0.77 to 0.88)) and those boosted or fully vaccinated (0.48 (0.34 to 0.70)). CONCLUSIONS: Return ED visits by patients with COVID-19 within 30 days were common during the first two pandemic years and were associated with multiple factors, many of which reflect known risk for worse outcomes. Future studies should assess reasons for revisit and opportunities to improve ED care and reduce resource use. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04702945.

Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients' perspectives.

BACKGROUND: Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients' perspectives about research recruitment and consent for research studies about COVID-19. METHODS: We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element. RESULTS: Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants' willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19. CONCLUSIONS: Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.

Due to the COVID-19 pandemic, many research groups started conducting research activities virtually. In this study, we invited individuals who had COVID-19 to share their views about how researchers recruit patients and get their consent to participate in studies about COVID-19. Through interviews and focus groups, we found that British Columbians who had COVID-19 are motivated to participate in COVID-related studies, as long as researchers maintain usual precautions around data privacy and accommodate preferences for participation. Future studies may use these patient perspectives to make informed decisions that will increase and support patient recruitment, consent and retention in research studies.

Characterizing people with frequent emergency department visits and substance use: a retrospective cohort study of linked administrative data in Ontario, Alberta, and B.C., Canada.

BACKGROUND: Substance use is common among people who visit emergency departments (EDs) frequently. We aimed to characterize subgroups within this cohort to better understand care needs/gaps, and generalizability of characteristics in three Canadian provinces. METHODS: This was a retrospective cohort study (April 1st, 2013 to March 31st, 2016) of ED patients in Ontario, Alberta, and British Columbia (B.C.) We included patients ≥ 18 years with substance use-related healthcare contact during the study period and frequent ED visits, defined as those in the top 10% of ED utilization when all patients were ordered by annual ED visit number. We used linked administrative databases including ED visits and hospitalizations (all provinces); mental heath-related hospitalizations (Ontario and Alberta); and prescriptions, physician services, and mortality (B.C.). We compared to cohorts of people with (1) frequent ED visits and no substance use, and (2) non-frequent ED visits and substance use. We employed cluster analysis to identify subgroups with distinct visit patterns and clinical characteristics during index year, April 1st, 2014 to March 31st, 2015. RESULTS: In 2014/15, we identified 19,604, 7,706, and 9,404 people with frequent ED visits and substance use in Ontario, Alberta, and B.C (median 37-43 years; 60.9-63.0% male), whose ED visits and hospitalizations were higher than comparison groups. In all provinces, cluster analyses identified subgroups with "extreme" and "moderate" frequent visits (median 13-19 versus 4-6 visits/year). "Extreme" versus "moderate" subgroups had more hospitalizations, mental health-related ED visits, general practitioner visits but less continuity with one provider, more commonly left against medical advice, and had higher 365-day mortality in B.C. (9.3% versus 6.6%; versus 10.4% among people with frequent ED visits and no substance use, and 4.3% among people with non-frequent ED visits and substance use). The most common ED diagnosis was acute alcohol intoxication in all subgroups. CONCLUSIONS: Subgroups of people with "extreme" (13-19 visits/year) and "moderate" (4-6 visits/year) frequent ED visits and substance use had similar utilization patterns and characteristics in Ontario, Alberta, and B.C., and the "extreme" subgroup had high mortality. Our findings suggest a need for improved evidence-based substance use disorder management, and strengthened continuity with primary and mental healthcare.

Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomised trial.

BACKGROUND: Acute atrial fibrillation is the most common arrythmia treated in the emergency department. Our primary aim was to compare conversion to sinus rhythm between pharmacological cardioversion followed by electrical cardioversion (drug-shock), and electrical cardioversion alone (shock-only). Our secondary aim was to compare the effectiveness of two pad positions for electrical cardioversion. METHODS: We did a partial factorial trial of two protocols for patients with acute atrial fibrillation at 11 academic hospital emergency departments in Canada. We enrolled adult patients with acute atrial fibrillation. Protocol 1 was a randomised, blinded, placebo-controlled comparison of attempted pharmacological cardioversion with intravenous procainamide (15 mg/kg over 30 min) followed by electrical cardioversion if necessary (up to three shocks, each of ≥200 J), and placebo infusion followed by electrical cardioversion. For patients having electrical cardioversion, we used Protocol 2, a randomised, open-label, nested comparison of anteroposterior versus anterolateral pad positions. Patients were randomly assigned (1:1, stratified by study site) for Protocol 1 by on-site research personnel using an online electronic data capture system. Randomisation for Protocol 2 occurred 30 min after drug infusion for patients who had not converted and was stratified by site and Protocol 1 allocation. Patients and all research and emergency department staff were masked to treatment allocation for Protocol 1. The primary outcome was conversion to normal sinus rhythm for at least 30 min at any time after randomisation and up to a point immediately after three shocks. Protocol 1 was analysed by intention to treat and Protocol 2 excluded patients who did not receive electrical cardioversion. This study is registered at ClinicalTrials.gov, number NCT01891058. FINDINGS: Between July 18, 2013, and Oct 17, 2018, we enrolled 396 patients, and none were lost to follow-up. In the drug-shock group (n=204), conversion to sinus rhythm occurred in 196 (96%) patients and in the shock-only group (n=192), conversion occurred in 176 (92%) patients (absolute difference 4%; 95% CI 0-9; p=0·07). The proportion of patients discharged home was 97% (n=198) versus 95% (n=183; p=0·60). 106 (52%) patients in the drug-shock group converted after drug infusion only. No patients had serious adverse events in follow-up. The different pad positions in Protocol 2 (n=244), had similar conversions to sinus rhythm (119 [94%] of 127 in anterolateral group vs 108 [92%] of 117 in anteroposterior group; p=0·68). INTERPRETATION: Both the drug-shock and shock-only strategies were highly effective, rapid, and safe in restoring sinus rhythm for patients in the emergency department with acute atrial fibrillation, avoiding the need for return to hospital. The drug infusion worked for about half of patients and avoided the resource intensive procedural sedation required for electrical cardioversion. We also found no significant difference between the anterolateral and anteroposterior pad positions for electrical cardioversion. Immediate rhythm control for patients in the emergency department with acute atrial fibrillation leads to excellent outcomes. FUNDING: Heart and Stroke Foundation of Canada and the Canadian Institutes of Health Research.

Patient Perspectives on Health Data Privacy and Implications for Adverse Drug Event Documentation and Communication: Qualitative Study.

BACKGROUND: Adverse drug events are unintended and harmful effects of medication use. Using existing information and communication technologies (ICTs) to increase information sharing about adverse drug events may improve patient care but can introduce concerns about data privacy. OBJECTIVE: This study aims to examine the views of patients and their caregivers about data protection when using ICTs to communicate adverse drug event information to improve patient safety. METHODS: We conducted an exploratory qualitative study. A total of 4 focus groups were held among patients who had experienced or were at risk of experiencing an adverse drug event, their family members, and their caregivers. We recruited participants through multiple avenues and iteratively analyzed the data using situational analysis. RESULTS: Of the 47 participants recruited, 28 attended our focus groups. We identified 3 primary themes. First, participants felt that improved information sharing about adverse drug events within their circle of care would likely improve care. Second, participants were concerned about data handling and inappropriate access but believed that the benefits of information sharing outweighed the risks of privacy breaches. Finally, participants were more concerned about data privacy in the context of stigmatized health conditions. CONCLUSIONS: Current conditions for maintaining health data privacy are consistent with participants' preferences, despite the fact that health data are susceptible to breaches and mismanagement. Information sharing that increases patient safety may justify potential privacy risks. Greater attention to patient concerns and the effect of social and contextual concerns in the design and implementation of health information technologies may increase patient confidence in the privacy of their information.

The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study.

BACKGROUND: Existing systems to document adverse drug events often use free text data entry, which produces nonstandardized and unstructured data that are prone to misinterpretation. Standardized terminology may improve data quality; however, it is unclear which data standard is most appropriate for documenting adverse drug event symptoms and diagnoses. OBJECTIVE: This study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. METHODS: We performed a mixed methods substudy of a multicenter retrospective chart review. We reviewed the research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. A total of 2 pharmacy research assistants independently entered the symptoms and diagnoses for the adverse drug events using four standards: Medical Dictionary for Regulatory Activities (MedDRA), Systematized Nomenclature of Medicine (SNOMED) Clinical Terms, SNOMED Adverse Reaction (SNOMED ADR), and International Classification of Diseases (ICD) 11th Revision. Disagreements between research assistants regarding the case-specific utility of data standards were discussed until a consensus was reached. We used consensus ratings to determine the proportion of adverse drug events covered by a data standard and coded and analyzed field notes from the consensus sessions. RESULTS: We reviewed 573 adverse drug events and found that MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and diagnoses. MedDRA had the highest number of matches between the research assistants, whereas ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. The research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, whereas least likely to encounter challenges with MedDRA. CONCLUSIONS: Usability, comprehensiveness, and accuracy are important features of data standards for documenting adverse drug event symptoms and diagnoses. On the basis of our results, we recommend the use of MedDRA.

Prospective Implementation of the Ottawa Subarachnoid Hemorrhage Rule and 6-Hour Computed Tomography Rule.

Background and Purpose- The Ottawa subarachnoid hemorrhage (SAH) rule identifies patients with headache requiring no testing for SAH, while the 6-hour computed tomography (CT) rule guides when to forgo a lumbar puncture. Our objectives were to: (1) estimate the clinical impact of the Ottawa SAH rule and the 6-hour-CT rule on testing rates (ie, CT, lumbar puncture, CT angiography); (2) validate the 6-hour-CT rule for SAH when applied prospectively in a new cohort of patients. Methods- We conducted a multicenter prospective before/after implementation study from 2011 to 2016 with 6 months follow-up at 6 tertiary-care Canadian Academic Emergency Departments. Consecutive alert, neurologically intact adults with headache were included. For intervention period, physicians were given a 1-hour lecture, pocket cards, posters were installed, and physicians indicated Ottawa SAH rule criteria when ordering CTs. SAH was defined by blood on CT, xanthochromia in cerebrospinal fluid, or >1×106/L red blood cells in cerebrospinal fluid with aneurysm. Results- We enrolled 3672 patients, 1743 before and 1929 after implementation, including 188 with SAH. Proportions undergoing CT was unchanged (88.0% versus 87.5%; P=0.643). Lumbar puncture use decreased (38.9% versus 25.9%; P<0.0001). Additional testing following CT (ie, lumbar puncture or CT angiography) decreased (51.3% versus 42.2%; P<0.0001). Admissions declined (9.8% versus 7.4%; P=0.011). Mean emergency department stay was unchanged (6.3±4.0 versus 6.4±4.2 hours; P=0.685). The Ottawa SAH rule was 100% (95% CI, 98.1%-100%) sensitive, and the 6-hour-CT rule was 95.5% (95% CI, 89.8-98.5) sensitive for SAH. The 6-hour-CT rule missed 5 SAHs: 1 radiology misread, 2 incidental aneurysms, 1 nonaneurysmal cause, and 1 profoundly anemic patient. Conclusions- The Ottawa SAH rule and the 6-hour-CT rule are highly sensitive and can be used routinely when SAH is considered in patients with headache. Implementing both rules was associated with a meaningful decrease in testing and admissions to hospital.

Preventable adverse drug events: Descriptive epidemiology.

AIM: Our objective was to identify preventable adverse drug events and factors contributing to their development. METHODS: We performed a retrospective chart review combining data from three prospective multicentre observational studies that assessed emergency department patients for adverse drug events. A clinical pharmacist and physician independently reviewed the charts, extracted data and rated the preventability of each adverse drug event. A third reviewer adjudicated all discordant or uncertain cases. We calculated the proportion of adverse drug events that were deemed preventable, performed multivariable logistic regression to explore the characteristics of patients with preventable events, and identified contributing factors. RESULTS: We reviewed the records of 1 356 adverse drug events in 1 234 patients. Raters considered 869 (64.1%) of adverse drug events probably or definitely preventable. Patients with mental health diagnoses (OR 1.8; 95% CI 1.3-2.5) and diabetes (OR 1.7; 95% CI 1.2-2.4) were more likely to present with preventable events. The medications most commonly implicated in preventable events were warfarin (9.4%), hydrochlorothiazide (4.5%), furosemide (4.0%), insulin (3.9%) and acetylsalicylic acid (2.7%). Common contributing factors included inadequate patient instructions, monitoring and follow-up, and reassessments after medication changes had been made. CONCLUSIONS: Our study suggests that patients with mental health conditions and diabetes require close monitoring. Efforts to address the identified contributing factors are needed.

Emergency department-based medication review on outpatient health services utilization: interrupted time series.

BACKGROUND: One in nine emergency department (ED) visits in Canada are caused by adverse drug events, the unintended and harmful effects of medication use. Medication reviews by clinical pharmacists are interventions designed to optimize medications and address adverse drug events to impact patient outcomes. However, the effect of medication reviews on long-term outpatient health services utilization is not well understood. This research studied the effect of medication review performed by clinical pharmacists on long-term outpatient health services utilization. METHODS: Data included information from 10,783 patients who were part of a prospective, multi-centre quality improvement evaluation from 2011 to 2013. Outpatient health services utilization was defined as total ED visits and physician contacts, aggregated to four physician specialty groups: general and family practitioners (GP); medical specialists; surgical specialists; and imaging and laboratory specialists. During triage, patients deemed high-risk based on their medical history, were systematically allocated to receive either a medication review (n = 6403) or the standard of care (n = 4380). Medication review involved a critical examination of a patient's medications to identify and resolve medication-related problems and communicate these results to community care providers. Interrupted time series analysis compared the effect of the intervention on health services utilization relative to the standard of care controlling for pre-intervention differences in utilization. RESULTS: ED-based pharmacist-led medication review did not result in a significant level or trend change in the primary outcome of total outpatient health services utilization. There were also no differences in the secondary outcomes of primary care physician visits or ED visits relative to the standard of care in the 12 months following the intervention. Our findings were consistent when stratified by age, hospital site, and whether patients were discharged on their index visit. CONCLUSION: This was the first study to measure long-term trends of physician visits following an ED-based medication review. The lack of differences in level and trend of GP and ED visits suggest that pharmacist recommendations may not have been adequately communicated to community-based providers, and/or recommendations may not have affected health care delivery. Future studies should evaluate physician acceptance of pharmacist recommendations and should encourage patient follow-up to community providers.

Relationship between GP visits and time spent in-hospital among insulin-dependent Canadians with type 2 diabetes.

OBJECTIVE: To determine whether higher frequency of GP visits among insulin-dependent patients with type 2 diabetes is associated with reduced hospitalizations. DESIGN: Nationally representative study using data from the 2013-2014 cycle of the Canadian Community Health Survey. SETTING: Canada. PARTICIPANTS: A study sample comprising 2203 insulin-dependent Canadians with type 2 diabetes. MAIN OUTCOME MEASURES: The relationship between GP visits (no visits, 1-5 visits, ≥ 6 visits) in the past year and the number of nights spent in-hospital. Zero-inflated negative binomial Poisson regression models were used to account for overdispersion and excess zeros. RESULTS: Higher numbers of GP visits were associated with spending fewer nights in-hospital. Patients with 1 to 5 GP visits had a significantly lower number of nights spent in-hospital (rate ratio of 0.38, 95% CI 0.25 to 0.56), as did those with 6 or more GP visits (rate ratio of 0.57, 95% CI 0.38 to 0.84) despite having reduced odds of not being hospitalized (odds ratio of 0.62, 95% CI 0.39 to 0.95), compared with those who did not see a GP in the past year, after adjusting for confounders. CONCLUSION: We found that insulin-dependent patients with diabetes who saw GPs more frequently were hospitalized less commonly compared with those who did not see a GP in the past year. Further research is needed to examine relationships with other types of follow-up, ideally using a longitudinal design.

Risk Factors for Misuse of Prescribed Opioids: A Systematic Review and Meta-Analysis.

STUDY OBJECTIVE: Increasing opioid prescribing has been linked to an epidemic of opioid misuse. Our objective is to synthesize the available evidence about patient-, prescriber-, medication-, and system-level risk factors for developing misuse among patients prescribed opioids for noncancer pain. METHODS: We performed a systematic search of the scientific and gray literature for studies reporting on risk factors for prescription opioid misuse. Two reviewers independently reviewed titles, abstracts, and full texts; extracted data; and assessed study quality. We excluded studies with greater than 50% cancer patients, palliative patients, and illicit opioid initiation. When possible, we synthesized the effect sizes of dichotomous risk factors and their associations with opioid misuse, using inverse-variance random-effects meta-analysis. We calculated the mean difference between opioid misusers and nonmisusers for continuous risk factors. When studies lacked homogeneity, we synthesized their results qualitatively. RESULTS: Of 9,629 studies, 65 met our inclusion criteria. Among patients with outpatient opioid prescriptions, the following factors were associated with the development of misuse: any current or previous substance use (odds ratio [OR] 3.55; 95% confidence interval [CI] 2.62 to 4.82), any mental health diagnosis (OR 2.45; 95% CI 1.91 to 3.15), younger age (OR 2.19; 95% CI 1.81 to 2.64), and male sex (OR 1.23; 95% CI 1.10 to 1.36). CONCLUSION: Although clinicians should endeavor to offer alternative pain management strategies to all patients, those who are younger, are male patients, and report a history of or current substance use or mental health diagnoses were associated with a greater risk of developing opioid misuse. Clinicians should consider prioritizing alternative pain management strategies for these higher-risk patients.

Organizational implications of implementing a new adverse drug event reporting system for care providers and integrating it with provincial health information systems.

Cross-sector collaborations between academia, government, and private industry, known as Triple Helix configurations, are increasingly common. In the health Information Technology (IT) sector, such configurations often also include health delivery organizations where technology is implemented and used. The complexity of collaborating within and between multiple organizations can present hurdles for innovators that are seldom discussed in the literature. We outline challenges we encountered in cross-sector collaboration and offer some guiding principles for decision-makers, academics, industry partners, and health delivery organizations to successfully negotiate divergent approaches to innovation and implementation. We discuss an innovative project that aims to implement a researcher-designed adverse drug event reporting system into clinical care and integrate it with provincial and health authority IT systems. Based on our experience, implementing an interoperable health IT system must extend beyond technical integration to encompass meaningful stakeholder engagement to ensure utility for end-users and beneficial impact for participating organizations.

Methods for evaluating adverse drug event preventability in emergency department patients.

BACKGROUND: There is a high degree of variability in assessing the preventability of adverse drug events, limiting the ability to compare rates of preventable adverse drug events across different studies. We compared three methods for determining preventability of adverse drug events in emergency department patients and explored their strengths and weaknesses. METHODS: This mixed-methods study enrolled emergency department patients diagnosed with at least one adverse drug event from three prior prospective studies. A clinical pharmacist and physician reviewed the medical and research records of all patients, and independently rated each event's preventability using a "best practice-based" approach, an "error-based" approach, and an "algorithm-based" approach. Raters discussed discordant ratings until reaching consensus. We assessed the inter-rater agreement between clinicians using the same assessment method, and between different assessment methods using Cohen's kappa with 95% confidence intervals (95% CI). Qualitative researchers observed discussions, took field notes, and reviewed free text comments made by clinicians in a "comment" box in the data collection form. We developed a coding structure and iteratively analyzed qualitative data for emerging themes regarding the application of each preventability assessment method using NVivo. RESULTS: Among 1356 adverse drug events, a best practice-based approach rated 64.1% (95% CI: 61.5-66.6%) of events as preventable, an error-based approach rated 64.3% (95% CI: 61.8-66.9%) of events as preventable, and an algorithm-based approach rated 68.8% (95% CI: 66.1-71.1%) of events as preventable. When applying the same method, the inter-rater agreement between clinicians was 0.53 (95% CI: 0.48-0.59), 0.55 (95%CI: 0.50-0.60) and 0.55 (95% CI: 0.49-0.55) for the best practice-, error-, and algorithm-based approaches, respectively. The inter-rater agreement between different assessment methods using consensus ratings for each ranged between 0.88 (95% CI 0.85-0.91) and 0.99 (95% CI 0.98-1.00). Compared to a best practice-based assessment, clinicians believed the algorithm-based assessment was too rigid. It did not account for the complexities of and variations in clinical practice, and frequently was too definitive when assigning preventability ratings. CONCLUSION: There was good agreement between all three methods of determining the preventability of adverse drug events. However, clinicians found the algorithmic approach constraining, and preferred a best practice-based assessment method.

Validation of the Ottawa Subarachnoid Hemorrhage Rule in patients with acute headache.

BACKGROUND: We previously derived the Ottawa Subarachnoid Hemorrhage Rule to identify subarachnoid hemorrhage (SAH) in patients with acute headache. Our objective was to validate the rule in a new cohort of consecutive patients who visited an emergency department. METHODS: We conducted a multicentre prospective cohort study at 6 university-affiliated tertiary-care hospital emergency departments in Canada from January 2010 to January 2014. We included alert, neurologically intact adult patients with a headache peaking within 1 hour of onset. Treating physicians in the emergency department explicitly scored the rule before investigations were started. We defined subarachnoid hemorrhage as detection of any of the following: subarachnoid blood visible upon computed tomography of the head (from the final report by the local radiologist); xanthochromia in the cerebrospinal fluid (by visual inspection); or the presence of erythrocytes (> 1 × 106/L) in the final tube of cerebrospinal fluid, with an aneurysm or arteriovenous malformation visible upon cerebral angiography. We calculated sensitivity and specificity of the Ottawa SAH Rule for detecting or ruling out subarachnoid hemorrhage. RESULTS: Treating physicians enrolled 1153 of 1743 (66.2%) potentially eligible patients, including 67 with subarachnoid hemorrhage. The Ottawa SAH Rule had 100% sensitivity (95% confidence interval [CI] 94.6%-100%) with a specificity of 13.6% (95% CI 13.1%-15.8%), whereas neuroimaging rates remained similar (about 87%). INTERPRETATION: We found that the Ottawa SAH Rule was sensitive for identifying subarachnoid hemorrhage in otherwise alert and neurologically intact patients. We believe that the Ottawa SAH Rule can be used to rule out this serious diagnosis, thereby decreasing the number of cases missed while constraining rates of neuroimaging.

Factors influencing time to computed tomography in emergency department patients with suspected subarachnoid haemorrhage.

BACKGROUND: CT has excellent sensitivity for subarachnoid haemorrhage (SAH) when performed within 6 hours of headache onset, but it is unknown to what extent patients with more severe disease are likely to undergo earlier CT, potentially inflating estimates of sensitivity. Our objective was to evaluate which patient and hospital factors were associated with earlier neuroimaging in alert, neurologically intact ED patients with suspected SAH. METHODS: We analysed data from two large sequential prospective cohorts of ED patients with acute headache undergoing CT for suspected SAH. We examined the time interval from headache onset to CT, both overall and subdivided from headache onset to hospital registration and from registration to CT. RESULTS: Among 2412 patients with headache, 194 had SAH, with 178 identified on unenhanced CT. Of these, 91 (51.1%) were identified by CT within 6 hours of headache onset and 87 after 6 hours. Patients with SAH had a shorter time from headache onset to hospital presentation (median 4.5 hours, IQR 1.7-22.7 vs 9.6 hours, IQR 2.8-46.0, p<0.001) and were imaged sooner after headache onset (6.4 hours, IQR 3.5-27.1 vs 12.6 hours, IQR 5.5-48.0, p<0.001) compared with those without SAH. The median time from in-hospital registration to CT scan was significantly shorter in those patients with SAH although this difference was less than 1 hour (1.9 hours, IQR 1.2-2.8 vs 2.5 hours, IQR 1.5-3.9, p<0.001). Arrival by ambulance (OR 3.1, 95% CI 1.94 to 4.98, p<0.001) and higher acuity at triage (OR 1.39, 95% CI 1.02 to 1.88, p=0.032) were among the factors associated with having CT imaging within 6 hours of headache onset. CONCLUSIONS: Time from headache onset to imaging is moderately associated with positive imaging for SAH. Delay to hospital presentation accounts for the largest fraction of time to imaging, especially those without SAH. These findings suggest limited opportunity to reduce lumbar puncture rates simply by accelerating in-hospital processes when imaging delays are under 2 hours, as diagnostic yield of imaging decreases beyond the 6-hour imaging window from headache onset.

Performance of trigger tools in identifying adverse drug events in emergency department patients: a validation study.

AIMS: Trigger tools are retrospective surveillance methods that can be used to identify adverse drug events (ADEs), unintended and harmful effects of medications, in medical records. Trigger tools are used in quality improvement, public health surveillance and research activities. The objective of the study was to evaluate the performance of trigger tools in identifying ADEs. METHODS: This study was a sub-study of a prospective cohort study which enrolled adults presenting to one tertiary care emergency department. Clinical pharmacists evaluated patients for ADEs at the point-of-care. Twelve months after the prospective study's completion, the patients' medical records were reviewed using eight different trigger tools. ADEs identified using each trigger tool were compared with events identified at the point-of-care. The primary outcome was the sensitivity of each trigger tool for ADEs. RESULTS: Among 1151 patients, 152 (13.2%, 95% confidence intervals (CI) 11.4, 15.3%) were diagnosed with one or more ADEs at the point-of-care. The sensitivity of the trigger tools for detecting ADEs ranged from 2.6% (95% CI 0.7, 6.6%) to 15.8% (95% CI 10.6, 22.8%). Their specificity varied from 99.3% (95% CI 98.6, 99.7) to 100% (95% CI 99.6, 100%). CONCLUSION: The trigger tools examined had poor sensitivity for identifying ADEs in emergency department patients, when applied manually and in retrospect. Reliance on these methods to detect ADEs for quality improvement, surveillance, and research activities is likely to underestimate their occurrence, and may lead to biased estimates.