Hamilton Integrated Research Ethics Board Research Articles

Protocol for the development of the Chatbot Assessment Reporting Tool (CHART) for clinical advice

IntroductionLarge language model (LLM)-linked chatbots are being increasingly applied in healthcare due to their impressive functionality and public availability. Studies have assessed the ability of LLM-linked chatbots to provide accurate...

Measures of retention in HIV care: A protocol for a mixed methods study.

Retention in HIV care is necessary to achieve adherence to antiretroviral therapy, viral load suppression, and optimal health outcomes. There is no standard definition for retention in HIV care, which compromises consistent and reliable reporting and comparison of retention across facilities, jurisdictions, and studies. The objective of this study is to explore how stakeholders involved in HIV care define retention in HIV care and their preferences on measuring retention. We will use an exploratory sequential mixed methods design involving HIV stakeholder groups such as people living with HIV, people involved in providing care for PLHIV, and people involved in decision-making about PLHIV. In the qualitative phase of the study, we will conduct 20-25 in-depth interviews to collect the perspectives of HIV stakeholders on using their preferred retention measures. The findings from the qualitative phase will inform the development of survey items for the quantitative phase. Survey participants (n = 385) will be invited to rate the importance of each approach to measuring retention on a seven-point Likert scale. We will merge the qualitative and quantitative findings phase findings to inform a consensus-building framework for a standard definition of retention in care. This study has received ethics approval from the Hamilton Integrated Research Ethics Board. The findings will be disseminated through peer-reviewed publications, conference presentations, and among stakeholder groups. This study has limitations; we won't be able to arrive at a standard definition; a Delphi technique amongst the stakeholders will be utilized using the framework to reach a consensus globally accepted definition.

Tande nou gwonde! (Hear us roar!)- Youth perspectives of maternal near-misses: Protocol for a photovoice study of young childbearing people's perspectives of maternal near-misses in northwest Haiti.

Globally, a shift is occurring to recognize the importance of young peoples' health and well-being, their unique health challenges, and the potential they hold as key drivers of change in their communities. In Haiti, one of the four leading causes of death for those 20-24 years old is pregnancy, childbirth, and the weeks after birth or at the end of a pregnancy. Important gaps remain in existing knowledge about youth perspectives of maternal health and well-being within their communities. Youth with lived experiences of maternal near-misses are well-positioned to contribute to the understanding of maternal health in their communities and their potential role in bringing about change. To explore and understand youth perspectives of maternal near-miss experiences that occurred in a local healthcare facility or at home in rural Haiti. We will conduct a qualitative, community-based participatory research study regarding maternal near-miss experiences to understand current challenges and identify solutions to improve community maternal health, specifically focused on youth maternal health. We will use Photovoice to seek an understanding of the lived experiences of youth maternal near-miss survivors. Participants will be from La Pointe, a Haitian community served by their local healthcare facility. We will undertake purposeful sampling to recruit approximately 20 female youth, aged 15-24 years. Data will be generated through photos, individual interviews and small group discussions (grouped by setting of near-miss experience). Data generation and analysis are expected to occur over a three-month period. Ethics approval will be sought from Centre Médical Béraca in La Pointe, Haiti, and from the Hamilton Integrated Research Ethics Board in Hamilton ON, Canada. We will involve community stakeholders, especially youth, in developing dissemination and knowledge mobilisation strategies. Our findings will be disseminated as an open access publication, be presented publicly, at conferences, and defended as part of a doctoral thesis.

Protocol for validating an algorithm to identify neurocognitive disorders in Canadian Longitudinal Study on Aging participants: an observational study

IntroductionIn population-based research, disease ascertainment algorithms can be as accurate as, and less costly than, performing supplementary clinical examinations on selected participants to confirm a diagnosis of a neurocognitive disorder...

Protocol for a longitudinal cohort study of Lyme disease with physical, mental and immunological assessment

IntroductionThere are limited data on the longitudinal impact of Lyme disease. Predictors of recovery have not been fully established using validated data collection instruments. There are sparse data on the...

Delphi consensus study to develop guidelines for the management of adults with borderline personality disorder in the emergency department: a protocol

IntroductionClinicians caring for adults with borderline personality disorder (BPD) in acute settings such as the emergency department (ED) have little evidence/guidance to base decisions on. Specific/detailed guidance for managing BPD...

Development of practice-based quality indicators for the primary care of older adults: a RAND/UCLA Appropriateness Method study protocol

IntroductionOlder adults have high rates of primary care utilisation, and quality primary care has the potential to address their complex medical needs. Family physicians have different levels of knowledge and...

Protocol for the COVID-19 Wellbeing and Stress Study: a longitudinal study of parent distress, biological stress and child biopsychosocial development during the pandemic and beyond

IntroductionThe COVID-19 pandemic has had a unique impact on the mental health and well-being of pregnant individuals and parents of young children. However, the impact of COVID-19-related stress during pregnancy...

Effects of the COVID-19 Pandemic on Primary Health Care for Chronic Conditions in Canada: Protocol for a Retrospective Pre-Post Study Using National Practice-Based Research Network Data.

Since the COVID-19 pandemic began, there have been concerns that interruptions to the health care system may have led to changes in primary care, especially for care of chronic conditions such as diabetes and heart failure. Such changes may have longer term implications for population health. This study aims to describe the impacts of the COVID-19 pandemic on indicators of primary care access, comprehensiveness, and appropriateness among adult patients, as well as on specific indictors of chronic conditions. Additionally, this study aims to determine whether any identified changes were associated with patient sociodemographic characteristics and multimorbidity. This is a retrospective, single-arm, pre-post study using Canadian Primary Care Sentinel Surveillance Network (CPCSSN) data. CPCSSN is a research network supported by a primary care electronic medical record database, comprising over 1500 physicians and nearly 2 million patients. We are examining changes in care (eg, frequency of contacts, laboratory tests and investigations, referrals, medications prescribed, etc) among adults. We will also examine indicators specific to evidence-based recommendations for care in patients with diabetes and those with heart failure. We will compare rates of outcomes during key periods of the pandemic between March 13, 2020, and December 31, 2022, with equal time periods before the pandemic. Differences will be examined among specific subgroups of adults, including by decade of age, number of comorbidities, and socioeconomic status. Regression models appropriate to outcome distributions will be used to estimate changes, adjusting for potential confounders. This analysis is part of a mixed-methods study with a qualitative component investigating how patients with diabetes with or without concurrent heart failure perceived the impact of the pandemic on access to primary care and health care-related decisions. This study was approved by the Hamilton Integrated Research Ethics Board (14782-C). The start date of this study was October 5, 2022, and the prospective end date is January 31, 2024. As of May 2023, the study cohort (n=875,934) is defined, data cleaning is complete, and exploratory analyses have begun. Extended analyses using 2022 data are planned once the new data becomes available. We will disseminate results through peer-reviewed publications and academic conference, as well as creating evidence briefs, infographics, and a video for policy maker and patient audiences. This study will investigate whether the COVID-19 pandemic has resulted in changes in the provision of primary care in Canada and whether these potential changes have led to gaps in care. This study will also identify patient-level characteristics associated with changes in care patterns across the COVID-19 pandemic. Indicators specific to chronic conditions, namely diabetes and heart failure, will also be explored to determine whether there were changes in care of these conditions. ClinicalTrials.gov NCT05813652; https://clinicaltrials.gov/ct2/show/NCT05813652. RR1-10.2196/49131.

The Feasibility of Establishing a Canadian Obstetric Survey System (CanOSS) for Severe Maternal Morbidity: Interim Results [ID: 1377349

INTRODUCTION: Obtaining granular data on events and circumstances leading to severe maternal morbidity (SMM) could complement large epidemiologic studies and enable targeted interventions to improve maternal health. This study aims to assess the feasibility of gathering such data from maternity units across Canada through a Canadian Obstetric Survey System (CanOSS). METHODS: The study is a sequential explanatory mixed-methods study, the first step of which is a nationwide survey of maternity unit leads. Semistructured qualitative interviews are being conducted with unit leads that expressed interest in response to the survey. Responses are reported using proportions and percentages. Interviews are being thematically analyzed. This study was approved by the Hamilton Integrated Research Ethics Board (HiREB) #14002. RESULTS: As of October 18, 2022, we have identified 306 maternity units nationally, and sent 218 surveys, with 59 maternity units across 8 provinces completing. Among these, 34 (83%) report having a system in place for reviewing SMM, conducted on an as-needed basis in 61% of units, and most commonly involving a multidisciplinary panel of experts with representation from nursing (85%), maternity unit leadership (79%), and hospital management (74%). A written report is prepared following 76% of meetings. Findings are shared with health care professionals involved in the event and formulated into recommendations in 79% and 82% of units, respectively. Importantly, 78% of respondents would be willing to contribute anonymized data on SMM within a centralized reporting system. Interviews have taken place with 14 unit leads. Interviewed participants unanimously agree that an obstetric survey system is needed. Concerns raised include privacy, resources, funding, and having a clear definition of SMM. CONCLUSION: This feasibility study will facilitate future planning, clarify barriers to be addressed, and resource implications for gathering data on SMM at a national level, and lay the foundations for a future CanOSS.

A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol

IntroductionSouth Asians are more likely to develop gestational diabetes mellitus (GDM) than white Europeans. Diet and lifestyle modifications may prevent GDM and reduce undesirable outcomes in both the mother and...

Tracheostomy in Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation: A Single-Center Experience.

Novel coronavirus-19 (COVID-19) has led to over 6 million fatalities globally. An estimated 75% of COVID-19 patients who require critical care admission develop acute respiratory distress syndrome (ARDS) needing invasive mechanical ventilation (IMV) and/or extracorporeal membrane oxygenation (ECMO). Due to prolonged ventilation requirements, these patients often also require tracheostomy. We performed a review of clinical outcomes in COVID-19 patients on ECMO at a high-volume tertiary care center in Hamilton, Ontario, Canada. We performed a retrospective case series, including 24 adult patients diagnosed with COVID-19 who required IMV, veno-venous (ECMO), and tracheostomy. All patients were included from April to December 2021. We extracted demographic and clinical variables pertaining to the tracheostomy procedure and ECMO therapy. We performed descriptive statistical analyses. This study was approved by the Hamilton Integrated Research Ethics Board (14217-C). We included 24 consecutive patients with COVID-19 who required tracheostomy while undergoing ECMO therapy. The mean age was 49.4 years [standard deviation (SD): 7.33], the majority of patients were male (75%), with mean body mass index of 32 (SD: 8.81). Overall mortality rate was 33.3%. Percutaneous tracheostomy was performed most frequently (83.3%) and, similar to open tracheostomy, was associated with a low rate of perioperative bleeding complications. Within surviving patients, the mean time to IMV weaning and decannulation was 60.2 (SD: 24.6) and 49.4 days (SD: 21.8), respectively. Percutaneous tracheostomy appears to be safe in COVID-19 patients on ECMO and holding anticoagulation 24 hours prior to and after tracheostomy may limit bleeding events in these patients.

Investigating divergent thinking and creative ability in surgeons (IDEAS): a survey protocol

IntroductionA strong pipeline of creative ideas and individuals is critical if we are to tackle the complex healthcare challenges we will face in the 21st century. The field of creativity...

Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies

IntroductionThe COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public’s understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (RecMap).Methods and analysisThis is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. The intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population’s results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach.Ethics and disseminationThrough Clinical Trials Ontario, the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media.Trial registrationClinicaltrials.gov NCT05358990. Registered on May 3, 2022

Validation of a classification to identify emergency department visits suitable for subacute and virtual care models: a randomised single-blinded agreement study protocol

IntroductionRedirecting suitable patients from the emergency department (ED) to alternative subacute settings may assist in reducing ED overcrowding while delivering equivalent care. The Emergency Department Avoidance Classification (EDAC) was constructed...

Surveying Canadian Pain Physicians' Attitudes and Beliefs Regarding Medical Cannabis for Chronic Noncancer Pain: A Qualitative Study.

Medical cannabis is commonly and increasingly used by Canadians to manage chronic pain. As of March 2021, Health Canada reported that approximately 300,000 Canadians who were authorized to access medical cannabis, which is more than a 1000% increase from the 24,000 registered in 2015. Physicians, however, receive limited information on therapeutic cannabis during their training, and their perceptions regarding this therapeutic option are uncertain. This study focused on exploring attitudes and beliefs of pain physicians regarding medical cannabis for the management of chronic noncancer pain. This study utilized a focused ethnography approach. Pain management clinicians within the Greater Toronto and Hamilton Area were recruited through snowball sampling methods, and individually interviewed. We applied thematic analysis to interview transcripts and identified representative quotes. The Hamilton Integrated Research Ethics Board reviewed and approved this project. Thirteen physicians who focused their clinical practice on pain management agreed to be interviewed, and three themes regarding medical cannabis emerged: 1) evidence regarding medical cannabis, 2) medical cannabis as first-line therapy for chronic pain, and 3) barriers to accessing medical cannabis. Subthemes of the last theme included out-of-pocket costs, stigma by society and healthcare providers, and lack of knowledge among physicians. Despite increasing use of medical cannabis for chronic pain among Canadians, pain physicians in our study expressed concerns regarding the evidence to support this therapy and acknowledged important barriers to access.

Anything but Cookbook Medicine: Exploring the Influence of Supervisor Practice Variability on Resident Learning in Thrombosis Medicine

Introduction Clinical practice variability is characterized by two or more expert clinicians who make different treatment decisions despite encountering a similar case. Thrombosis Medicine is an example of a specialty that has a large evidence base to support decision-making and where practice variability is common. Our objective was to explore how residents experience and interpret inter-supervisor clinical practice variability in Thrombosis Medicine, and how these variations influence learning. Methods Seventeen senior residents in Internal Medicine, Hematology or Thrombosis Medicine (Postgraduate Year [PGY] 3-6) participated in semi-structured interviews. Data collection and analysis occurred iteratively and concurrently in a manner consistent with constructive grounded theory methodology. Variation theory was used as a sensitizing concept. A central tenet of this theory is that learning occurs by experiencing three sequential patterns of variation: contrast, generalization, and fusion. All transcripts were coded in duplicate by paired members of the study team. Participants were recruited purposively with regard to their field of training until thematic saturation was reached. The primary investigator maintained an audit trail and reflexivity journal. Member checking was performed. Dedoose (version 8.0.35) was used for all analyses. The Hamilton Integrated Research Ethics Board reviewed the study. Results Clinical practice variability was common and generally viewed positively. Residents attributed clinical practice variability to supervisor personality differences, inter-institutional differences, availability and interpretation of evidence, differences in patient preferences and characteristics, and their own participation in the decision-making process. Inherent differences between supervisors, including personality traits, risk tolerance, and prior educational and clinical experiences were a major contributor. Clinical practice variability was felt to be most common when the clinical problem had scant or conflicting evidence to guide practice, for example, in the treatment of subsegmental pulmonary embolism or splanchnic vein thrombosis. Supervisors and learners often took patient preferences into account when making a decision, especially when the net clinical benefit of anticoagulation was uncertain. Supervisor-learner discussions were critical to learning from clinical practice variability. Through these interactions, residents asked clarifying questions, and supervisors shared tacit knowledge, elaborated on their prior experiences, compared and contrasted similar cases, and articulated their clinical reasoning. Residents endorsed the view that a certain baseline level of knowledge is required to appreciate the nuances that are uncovered by clinical practice variability. Junior residents (PGY 2-4) were often assessment-focused and made note of practice patterns between their supervisors in order to predict their supervisors' preferences for future cases. More experienced residents (PGY 5-6), especially those pursuing advanced training in Thrombosis Medicine, were more likely to view clinical practice variability as a means to improve their own decision-making skill in preparation for independent practice. Consistent with variation theory, clinical practice variability helped residents to discern critical aspects that influenced decision-making (contrast), group similar cases together so that the appropriate evidence could be applied (generalization), and weigh multiple variables to make a treatment decision (fusion). Observing practice variability was more helpful for senior learners and less so for junior learners as inexperience and knowledge gaps made it difficult to reconcile differences. Conclusion Residents had a generally positive perception of clinical practice variability in the workplace. Practice variability helped residents discern critical aspects, group similar patients together and practice individualized medicine. Reflection, literature review, and case discussions were felt to maximize learning from practice variability. Clinical supervisors and curriculum designers can promote learning from practice variability through first and second order scaffolding, modeling, coaching, and thinking aloud.

Novel care pathway to optimise antimicrobial prescribing for uncomplicated community-acquired pneumonia: study protocol for a prospective before–after cohort study in the emergency department of a tertiary care Canadian children’s hospital

IntroductionEvidence-based recommendations for paediatric community-acquired pneumonia (CAP) diagnosis and management are needed. Uncomplicated CAP is often caused by respiratory viruses, especially in younger children; these episodes self-resolve without antibiotic treatment....

Responsiveness of the HUG-5 in an outpatient clinic: a 12-month randomised feasibility study protocol

IntroductionGlaucoma is a progressive, chronic condition that can have a significant impact on a patient’s health-related quality of life (HRQoL). Validated, disease-specific HRQoL tools such as the Health Utility for...

Intravenous ketorolac versus morphine in children presenting with suspected appendicitis: a pilot single-centre non-inferiority randomised controlled trial

ObjectivesDespite a lack of evidence demonstrating superiority to non-steroidal anti-inflammatory drugs, like ketorolac, that are associated with lower risk of harms, opioids remain the most prescribed analgesic for acute abdominal...