Autonomous Surface and Underwater Vehicles as Effective Ecosystem Monitoring and Research Platforms in the Arctic-The Glider Project.

Effective ocean management requires integrated and sustainable ocean observing systems enabling us to map and understand ecosystem properties and the effects of human activities. Autonomous subsurface and surface vehicles, here collectively referred to as "gliders", are part of such ocean observing systems providing high spatiotemporal resolution. In this paper, we present some of the results achieved through the project "Unmanned ocean vehicles, a flexible and cost-efficient offshore monitoring and data management approach-GLIDER". In this project, three autonomous surface and underwater vehicles were deployed along the Lofoten-Vesterålen (LoVe) shelf-slope-oceanic system, in Arctic Norway. The aim of this effort was to test whether gliders equipped with novel sensors could effectively perform ecosystem surveys by recording physical, biogeochemical, and biological data simultaneously. From March to September 2018, a period of high biological activity in the area, the gliders were able to record a set of environmental parameters, including temperature, salinity, and oxygen, map the spatiotemporal distribution of zooplankton, and record cetacean vocalizations and anthropogenic noise. A subset of these parameters was effectively employed in near-real-time data assimilative ocean circulation models, improving their local predictive skills. The results presented here demonstrate that autonomous gliders can be effective long-term, remote, noninvasive ecosystem monitoring and research platforms capable of operating in high-latitude marine ecosystems. Accordingly, these platforms can record high-quality baseline environmental data in areas where extractive activities are planned and provide much-needed information for operational and management purposes.

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.

Adverse drug event reporting systems: a systematic review.

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.

Beliefs and perceptions of patient safety event reporting in a Canadian Emergency Department: a qualitative study.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Patient choice may improve adherence to follow-up in cervical screening: a randomised-control trial.

AIMS: We investigated whether patient choice of follow-up type improves health-related quality of life (HrQOL) and follow-up attendance in women who have undergone large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3). METHODS: A three-armed randomised controlled trial including women with newly diagnosed CIN 2-3 post-LLETZ treatment was performed. Consenting women were randomised (1:1:1) to either: (a) colposcopy review at the hospital, (b) follow-up with high-risk human papilloma virus (HrHPV) and smear test in the community or (c) a choice of the aforementioned follow-up options, six months post-treatment. HrQOL was measured and participants were surveyed at baseline and six months regarding preferences for follow-up. RESULTS: Sixty-eight participants were randomised to follow-up (a), 67 to follow-up (b) and 65 to follow-up (c) (n=200). At six months post-treatment, 47% of patients indicated a preference for (a), 24% for (b) and 26% for (c). We found no significant difference in HrQOL between the study arms. Attendance was greater among patients who chose their follow-up (95.5% vs 91.1%, p=0.06). CONCLUSION: Choice of follow-up was associated with greater attendance. However, larger studies examining the effects of HrQOL and attendance to different follow-ups are warranted.

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset.

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.

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

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.

Patient Perceptions About Data Sharing & Privacy: Insights from ActionADE.

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.

Designing Novel Health ICTs to Support Work, Not Generate It: Five Principles.

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.

Pilot-testing an adverse drug event reporting form prior to its implementation in an electronic health record.

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.

Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design.

BACKGROUND: Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs. OBJECTIVE: We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada. METHODS: To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting. RESULTS: This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs. CONCLUSIONS: We take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers' failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians' workflow, and design the system to optimize its uptake into practice.

Findings and outcome of teenage women referred for colposcopy at Christchurch Women's Hospital, New Zealand.

AIM: To determine the colposcopic findings, treatment, and follow up of 15-19 year old women referred to a large public colposcopy clinic. METHOD: A retrospective review of the colposcopy database and clinical records between 1995 and 2001. RESULTS: 243 women or 4.7% of new referrals were aged 15-19 years. Referral smears were high-grade squamous lesions (HGSL) in 15%, and low-grade squamous lesions (LGSL) or atypical squamous cells of uncertain significance (ASCUS) in 82%. Following colposcopy, 21% had biopsy proven high-grade abnormalities but only 4% had grade 3 cervical intraepithelial neoplasia (CIN3). Of those with LGSL or ASCUS smears, 2% had biopsy-proven CIN3; and of those with HGSL smears, 14% had biopsy proven CIN3. Women underwent a mean of 4.1 colposcopy sessions; 67% underwent treatment and 26% were discharged without treatment. Sixteen percent of the women were lost to follow-up. Treatment failure occurred in 8% of those treated. For women undergoing observation, 25% were discharged after the first follow-up and less than 3% progressed to CIN3. CONCLUSIONS: The rate of CIN3 in women under the age of 20 referred to colposcopy at Christchurch Women's Hospital is low. Screening teenage women results in invasive investigation and treatment without proven benefit and is not recommended. A conservative approach to the management of young women with low-grade squamous intraepithelial abnormalities is also advocated.

Does regular cervical screening protect women from microinvasive squamous cell carcinoma of the cervix? A retrospective case-control study.

OBJECTIVES: To compare the smear histories of women with microinvasive squamous cell carcinoma (SCC) of the cervix to those of women with cervical intraepithelial neoplasia grade 3 (CIN3). DESIGN: Retrospective case-control study. SETTING: A large public hospital gynaecology unit. Sample Twenty-nine consecutive women with microinvasive SCC FIGO stage 1A1 (cases). Fifty-five age-matched controls with histologically confirmed CIN3 (controls). METHODS: The cases and controls were selected from institutional databases; smear histories and other information was retrieved from hospital notes or following consent from other records. MAIN OUTCOME MEASURES: The time from index smear to prior screening smear and participation in the National Screening Programme (NCSP). RESULTS: Only 35% of cases compared with 78% controls had a smear in the last 3 years (P = 0.00008.) Cases had a longer median interval between the abnormal smear that resulted in diagnosis and the previous screening smear (4 years) compared with controls (2 years). Cases were less likely to be enrolled in the NCSP (65%) prior to their index smear than controls (85%). CONCLUSION: Delayed interval screening was more frequent in women with 1A1 SCC than CIN3.

Is there a role for colposcopy in the follow-up of treated low grade squamous intraepithelial lesions?

Is routine colposcopy justified in the follow up of treated low grade squamous intraepithelial lesions (LGSIL) of the cervix? This retrospective study analysed the notes of women treated at a public hospital colposcopy clinic over a 5-year period. Two hundred and fifty women fulfilled the inclusion criteria of whom 11 had persistent disease. Of these, only one case of LGSIL was detected by colposcopy in the absence of abnormal cytology. In the present study, routine colposcopy offered minimal additional benefit over cytology.