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Patient safety events (PSEs) are unwanted or unexpected events that occur during medical care. High cognitive loads and frequent interruptions make emergency departments (EDs) uniquely error prone environments. Yet, frontline clinicians rarely report PSEs using incident reporting systems. The incidence, severity, and preventability of PSEs thus remain poorly understood, and contributing factors are understudied. We sought to understand ED staff beliefs and perceptions about their PSE reporting system and what features they believe are important in such a system.We conducted a qualitative study among healthcare providers working in the ED and departmental leadership. We recruited participants via email and held a series of interviews, focus groups, and participatory workshops. We iteratively analyzed the data using the constant comparative method and used thematic analysis to establish themes.50 participants attended at least one focus group, interview, or workshop. Participants perceived that PSE reporting through formal channels in the ED was challenging. Clinicians had an inherent desire to report PSEs and do so through numerous informal channels, yet underreported in formal reporting systems. The current PSE reporting system did not meet frontline staff needs and was viewed as ineffective in improving care quality and safety. We identified three key features for an improved PSE reporting system: (1) clear definitions; (2) transparency; and (3) simplicity.In this study, we have identified ideal features for PSE reporting processes to meet the needs of both frontline staff and departmental leadership based on perceptions of current PSE reporting practices. Improved PSE reporting processes have the potential to increase PSE reporting in the ED overall, increasing the availability of information about PSEs to support quality improvement and improve patient safety.RéSUMé: OBJECTIFS: Les événements liés à la sécurité des patients (ESP) sont des événements non désirés ou inattendus qui se produisent pendant les soins médicaux. La charge cognitive élevée et les interruptions fréquentes font des services d'urgence des environnements particulièrement propices aux erreurs. Pourtant, les cliniciens de première ligne signalent rarement les ESP à l'aide des systèmes de déclaration des incidents. L'incidence, la gravité et le caractère évitable des ESP restent donc mal compris, et les facteurs contributifs sont peu étudiés. Nous avons cherché à comprendre les croyances et les perceptions du personnel des services d'urgence à l'égard de leur système de déclaration des ESP et les caractéristiques qu'ils jugent importantes dans un tel système. MéTHODES: Nous avons mené une étude qualitative auprès des prestataires de soins de santé travaillant aux urgences et de la direction du service. Nous avons recruté des participants par courrier électronique et organisé une série d'entretiens, de groupes de discussion et d'ateliers participatifs. Nous avons analysé les données de manière itérative en utilisant la méthode comparative constante et avons utilisé l'analyse thématique pour établir des thèmes. RéSULTATS: 50 participants ont assisté à au moins un groupe de discussion, une entrevue ou un atelier. Les participants estiment qu'il est difficile de rendre compte de l'ESP par les voies officielles au sein de l'urgence. Les cliniciens avaient un désir inhérent de signaler les ESP et le faisaient par de nombreuses voies informelles, mais ils étaient sous-déclarés dans les systèmes de déclaration officiels. Le système actuel de déclaration des ESP ne répondait pas aux besoins du personnel de première ligne et était considéré comme inefficace pour améliorer la qualité et la sécurité des soins. Nous avons identifié trois caractéristiques clés pour un système amélioré de rapports sur les ESP : (1) des définitions claires ; (2) la transparence ; et (3) la simplicité. CONCLUSIONS: Dans cette étude, nous avons identifié les caractéristiques idéales des processus de déclaration des ESP afin de répondre aux besoins du personnel de première ligne et de la direction du département, en fonction des perceptions des pratiques actuelles de déclaration des ESP. L'amélioration des processus de déclaration des ESP a le potentiel d'accroître la déclaration des ESP dans les urgences en général, augmentant ainsi la disponibilité des informations sur les ESP pour soutenir l'amélioration de la qualité et améliorer la sécurité des patients.

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.

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.

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. CLINICALTRIAL

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.

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.

Rationale, aims, and objectives Local health administrators implemented chronic obstructive pulmonary disease and heart failure admission order sets to increase guideline adherence. We explored the impact of these order sets on workflows and guideline adherence in the internal medicine specialty in two Canadian teaching hospitals. Methods A mixed methods study combined shadowing care providers (250 h), meeting observation and interviews (11 h), and patient medical chart audits for heart failure (n = 120) and chronic obstructive pulmonary disease (n = 120) patients. The chart audits analysed details of the admission process and 14 guideline elements associated with heart failure (nine) and chronic obstructive pulmonary disease (five). Results A subset (10/14) of the evaluated guideline elements were included in the heart failure or chronic obstructive pulmonary disease order sets. Order set use significantly increased adherence to some (4/10) of these elements. However, our qualitative work uncovered a perception that use of these two order sets increased order duplication. Our chart audits supported this perception. Order set use increased order duplication for heart failure (92% vs 43%) and chronic obstructive pulmonary disease (75% vs 43%). Conclusion It is unclear whether, for these two hospitals, the gains brought by implementation of chronic obstructive pulmonary disease and heart failure admission order sets were worth their associated organisational shortcomings. Problems with order set implementation appeared to stem from poor integration with pre-existing complex organisational systems. Health administrators and clinicians interested in implementing order sets within their own hospitals need to remain cognizant of how these tools will fit into existing systems and practices.

Aim Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. Methods We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. Results We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). Conclusion We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.

BACKGROUND Numerous published articles show that clinicians do not follow clinical practice guidelines (CPGs). However, a few studies explore what clinicians consider evidence and how they use different forms of evidence in their care decisions. Many of these existing studies occurred before the advent of smartphones and advanced Web-based information retrieval technologies. It is important to understand how these new technologies influence the ways clinicians use evidence in their clinical practice. Mindlines are a concept that explores how clinicians draw on different sources of information (including context, experience, medical training, and evidence) to develop collectively reinforced, internalized tacit guidelines. OBJECTIVE The aim of this paper was to explore how evidence is integrated into mindline development and the everyday use of mindlines and evidence in care. METHODS We draw on ethnographic data collected by shadowing internal medicine teams at 2 teaching hospitals. Fieldnotes were tagged by evidence category, teaching and care, and role of the person referencing evidence. Counts of these tags were integrated with fieldnote vignettes and memos. The findings were verified with an advisory council and through member checks. RESULTS CPGs represent just one of several sources of evidence used when making care decisions. Some forms of evidence were predominately invoked from mindlines, whereas other forms were read to supplement mindlines. The majority of scientific evidence was accessed on the Web, often through smartphones. How evidence was used varied by role. As team members gained experience, they increasingly incorporated evidence into their mindlines. Evidence was often blended together to arrive at shared understandings and approaches to patient care that included ways to filter evidence. CONCLUSIONS This paper outlines one way through which the ethos of evidence-based medicine has been incorporated into the daily work of care. Here, multiple Web-based forms of evidence were mixed with other information. This is different from the way that is often articulated by health administrators and policy makers whereby clinical practice guideline adherence is equated with practicing evidence-based medicine.

BACKGROUND Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized. OBJECTIVE The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety. METHODS We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format. RESULTS We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations. CONCLUSIONS By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.

BACKGROUND Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. OBJECTIVE Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. METHODS This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. RESULTS We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. CONCLUSIONS Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.

Information communication technologies (ICTs) may improve health delivery by enhancing informational continuity of care and enabling secondary use of health data including public health surveillance and research. ICTs also introduce concerns related to privacy. In this paper, we examine and address this tension in the context of the development and implementation of a novel platform that will enable the documentation and communication of patient-specific ADE information, titled ActionADE. We explored privacy concerns qualitatively from the perspective of patients. Our findings will inform a series of recommendations for system design that seek to balance the need to both share and protect personal health information.

Background: Numerous published articles show that clinicians do not follow clinical practice guidelines (CPGs). However, a few studies explore what clinicians consider evidence and how they use different forms of evidence in their care decisions. Many of these existing studies occurred before the advent of smartphones and advanced Web-based information retrieval technologies. It is important to understand how these new technologies influence the ways clinicians use evidence in their clinical practice. Mindlines are a concept that explores how clinicians draw on different sources of information (including context, experience, medical training, and evidence) to develop collectively reinforced, internalized tacit guidelines. Objective: The aim of this paper was to explore how evidence is integrated into mindline development and the everyday use of mindlines and evidence in care. Methods: We draw on ethnographic data collected by shadowing internal medicine teams at 2 teaching hospitals. Fieldnotes were tagged by evidence category, teaching and care, and role of the person referencing evidence. Counts of these tags were integrated with fieldnote vignettes and memos. The findings were verified with an advisory council and through member checks. Results: CPGs represent just one of several sources of evidence used when making care decisions. Some forms of evidence were predominately invoked from mindlines, whereas other forms were read to supplement mindlines. The majority of scientific evidence was accessed on the Web, often through smartphones. How evidence was used varied by role. As team members gained experience, they increasingly incorporated evidence into their mindlines. Evidence was often blended together to arrive at shared understandings and approaches to patient care that included ways to filter evidence. Conclusions: This paper outlines one way through which the ethos of evidence-based medicine has been incorporated into the daily work of care. Here, multiple Web-based forms of evidence were mixed with other information. This is different from the way that is often articulated by health administrators and policy makers whereby clinical practice guideline adherence is equated with practicing evidence-based medicine.

In this paper, we offer five principles to inform how health ICT designers and healthcare organizations address and mitigate issues relating to clinician documentation burden. We draw on our experience and empirical work designing an ICT intervention, ActionADE, to illustrate how our team developed and will use these principles to ease documentation burden for clinician-users.

Background Adverse drug events (ADEs), harmful unintended consequences of medication use, are a leading cause of hospital admissions, yet are rarely documented in a structured format between care providers. We describe pilot-testing structured ADE documentation fields prior to integration into an electronic medical record (EMR). Methods We completed a qualitative study at two Canadian hospitals. Using data derived from a systematic review of the literature, we developed screen mock-ups for an ADE reporting platform, iteratively revised in participatory workshops with diverse end-user groups. We designed a paper-based form reflecting the data elements contained in the mock-ups. We distributed them to a convenience sample of clinical pharmacists, and completed ethnographic workplace observations while the forms were used. We reviewed completed forms, collected feedback from pharmacists using semi-structured interviews, and coded the data in NVivo for themes related to the ADE form. Results We completed 25 h of clinical observations, and 24 ADEs were documented. Pharmacists perceived the form as simple and clear, with sufficient detail to capture ADEs. They identified fields for omission, and others requiring more detail. Pharmacists encountered barriers to documenting ADEs including uncertainty about what constituted a reportable ADE, inability to complete patient follow-up, the need for inter-professional communication to rule out alternative diagnoses, and concern about creating a permanent record. Conclusion Paper-based pilot-testing allowed planning for important modifications in an ADE documentation form prior to implementation in an EMR. While paper-based piloting is rarely reported prior to EMR implementations, it can inform design and enhance functionality. Piloting with other groups of care providers and in different healthcare settings will likely lead to further revisions prior to broader implementations.

Introduction:To address local workability, cross-setting variation, and clinician and patient perspectives, health technology assessment (HTA) practitioners and health system decision-makers incorporate varying forms of qualitative evidence into evaluations of novel health technologies. Employing principles and methods from long-established sociotechnical fields such as participatory design (PD) may help HTA teams in the production of formal, rigorous ‘practice-based evidence’.Methods:We draw on a theoretical review of foundational PD literature and experiences using PD for a large-scale health information technology project to summarize principles and strategies for the effective introduction and evaluation of new technologies in healthcare.Results:HTA may benefit from observing some of the core commitments of PD: (i) Ensuring that technologies enhance rather than detract from the quality of working life; (ii) Fostering democratic engagement in the implementation and evaluation of technologies; and (iii) Proceeding via direct partnership with technology users. These are practical commitments stemming from the recognition that technology implementation entails re-configuring existing practices and social arrangements. The experts of this existing milieu are the people on the ground, who may reject or underutilize technologies that they perceive as impractical, ill-adapted to their needs, or having negative consequences on their work. At the same time, PD recognizes that local activities occur within larger systems and that effective technology introduction also requires attention to macro-politics (e.g. governance challenges, competing priorities). PD employs a diversity of methods (e.g. participant observation, focus groups, workshops, interviews) to develop evidence that is holistically informed.Conclusions:Many of the challenges that HTA faces, both in terms of evidence production and translation, have been encountered before in PD. Given that decision-making around health technologies necessarily involves consideration of many forms of qualitative evidence, there is value in producing and evaluating such evidence in carefully designed manner – a challenge to which fields like PD can lend a wealth of experience.

The aim of this manuscript is to identify for the reader how communication gaps during handovers from hospital personnel to parents after pediatric day surgery can endanger patient safety. Variables analyzed include parent-reported quality of communication and hospital safety culture, medication safety, surgical wound care, and nausea and vomiting knowledge. Data are obtained via a 21-item questionnaire. The reader is informed of a technique for communication quality measurement that combines naturalistic observation of the discharge process, a theoretical model of discharge communication and safety domain modeling and analysis. The reader is informed via the discharge communication and safety domain model of the areas posing the most risk to patient safety in the post-discharge period.