University Research Ethics Board Research Articles

Syphilis Point of Care Rapid Test and Immediate Treatment Evaluation (SPRITE) study: a mixed-methods implementation science research protocol of eight public health units in Ontario, Canada

IntroductionUrgent, tailored and equitable action is needed to address the alarming rise in syphilis rates in Canada. In the last decade, the rates of infectious syphilis have increased by 345%...

Ontario Midwives’ Attitudes About Abortion and Abortion Provision

Objective: In Ontario and across Canada, midwives do not provide pregnancy termination but provide referrals and support for clients. This differs from a number of international jurisdictions where abortion has been added to the midwifery scope of practice, resulting in safe outcomes for women and improved access to services. This study sought to survey Ontario midwives’ general attitudes towards abortion and willingness to incorporate abortion into the midwifery scope of practice. Ethics approval for the study was obtained from the Ryerson University Research Ethics Board. Methods: An Internet-based cross-sectional survey was sent to all registered midwives in Ontario via the Association of Ontario Midwives. The survey consisted of seven sections, with a total of 43 Likert scale questions, 17 general questions, and space for open-ended comments at the end of each section. Comments were coded and analyzed for common themes. Results: The survey was distributed to 523 midwives, all of the midwives registered in Ontario at the time of the study (2011). A total of 359 midwives participated, representing a response rate of 68% of all registered midwives in Ontario. The majority of respondents identified themselves as pro-choice; however, there were “limits to choice” expressed by many participants. Abortion was considered less acceptable at later gestations or for specific reasons such as gender selection or minor fetal anomalies. Study participants were divided over whether abortion should be added to midwifery scope of practice. Comfort with providing abortion services decreased as procedures were perceived to be more invasive or as requiring more medical expertise. The addition of misoprostol to Ontario midwives’ pharmacopoeia for early medical terminations was the most favoured expansion for midwifery scope of practice. Respondents were less willing to add surgical techniques to midwifery scope of practice. Midwives identified the current models of compensation and practice in Ontario, issues related to hospital integration, and opposition from clients as significant barriers to the provision of abortion services. Limited education about abortion during midwifery training and the desire for more learning opportunities were additional themes that emerged in this study. Conclusion: This is the first study in Canada about midwives’ attitudes towards abortion and the inclusion of abortion within midwifery scope of practice. Further research in other Canadian jurisdictions would be useful to examine systemic issues, barriers, and attitudes at a national level. For abortion to be included within the scope of practice of Ontario midwives, issues related to the current model of care, compensation, and supplemental education would need to be addressed. This article has been peer reviewed.

Bridging Educational Grant in Nursing (BEGIN) students’ intentions for retention in long-term, home and community care: A survey protocol

IntroductionRetention of nurses in long-term care (LTC) and home and community care (HCC) settings is a growing concern. Previous evidence underscores factors which contribute to nurses’ intentions for retention in...

History and physical exam: a retrospective analysis of a clinical opportunity

BackgroundAll learners at the Northern Ontario School of Medicine University complete a longitudinal integrated clerkship experience in their third year, which serves to improve learner experience with community and clinical acute and chronic health needs. Early in the program, Muskoka faculty (two of the 15 LIC sites of NOSM U) became aware that learners never had the occasion to complete a full history and physical exam on a real patient with complex needs. Recognizing this as a critical experience, a program was initiated to provide learners with this opportunity. This manuscript reports on the effectiveness and impact of this novel program and outlines the procedure developed to incorporate a similar program should communities see the relevance.MethodsUsing a mixed method design, feedback was collected from learners and preceptors following the implementation of a novel learning opportunity for clinical clerks. Learners completed a full history and physical exam on volunteer complex patients, with supervision and immediate feedback. Using semi structured surveys, data was collected from each learner and preceptor to determine the program impact and optimize the program. Laurentian University research ethics board, certificate number 6021120.ResultsBoth learners and preceptors agreed this was a valuable experience for learners, a good use of their time and contributed to essential skills including, communication, time management and appropriate data collection. The use of real patients was reported to be very appropriate by learners and faculty and often highlighted gaps in the learner’s knowledge that they were then able to address.ConclusionFeedback collected in this study confirms that providing medical learners the opportunity to complete a full history and physical exam with supervision and feedback was significantly beneficial from both a clinical and a skills-based aspect. Requiring learners to complete this task within the established period forced them to manage their time, focus on clinical consideration and remain on task. Enhancing learning opportunities is associated with improved outcomes and understanding in medical learners. Positive community experience is also related to learner retention, which is paramount for attracting new physicians in a time with significantly limited human health resources.

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...

Developing an in-depth understanding of patient and caregiver engagement across care transitions from hospital: protocol for a qualitative study exploring experiences in Canada

IntroductionPatient and caregiver engagement is critical, and often compromised, at points of transition between care settings, which are more common, and more challenging, for patients with complex medical problems. The...

Pan-Canadian study of psychiatric care (PCPC): protocol for a mixed-methods study

IntroductionThe Canadian population has poor and inequitable access to psychiatric care despite a steady per-capita supply of psychiatrists in most provinces. There is some quantitative evidence that practice style and...

Responding to COVID-19 with integrative health and sheltering models for persons experiencing homelessness in Southern Ontario, Canada: protocol for a qualitative study exploring implementation and sustainability

IntroductionCOVID-19 has disproportionately impacted persons experiencing homelessness in Canada, who are at an increased risk of infection and severe outcomes. In response to the pandemic, several regions have adopted programmes...

Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study

IntroductionPatient engagement in healthcare research is a necessity to ensure that research objectives align with priorities, outcomes and needs of the population under study, and to facilitate ease of implementation...

Evaluation of a Virtual Team-Based Project Designed to Improve Chronic Wound Patient Care in Ontario, Canada.

To evaluate the effectiveness of the Extension for Community Healthcare Outcomes Ontario Skin and Wound Care project, a virtual team-based endeavor designed to improve the care of patients with chronic wounds. The study team conducted phone interviews with healthcare professionals (n = 8) regarding their patients (n = 10). The management recommendations were grouped, and the study participants questioned concerning the implementation of the recommendations. Interviews were recorded and transcribed, and the transcripts were analyzed for common themes. The Queen's University Research Ethics Board approved this study. Interviews documented improvement in 50% of patients; the other half of the patients did not improve because of patient- and healthcare-system barriers. Three of five nonhealing patients were nonadherent regarding compression, and only one of six suggested biopsies were carried out. The investigators noted three primary reasons for the lack of recommendation implementation: (1) could not obtain a diagnostic procedure, (2) lack of a diagnosis, and (3) patient was reluctant to make a lifestyle change. Major themes included problems in care coordination and suboptimal patient and provider education, along with other obstacles to management. Participants stated that the project provided a beneficial learning experience. The findings highlighted a lack of integrated and coordinated interprofessional chronic wound care.

Study protocol for CELLAR (COVID-related Eating Limitations and Latent dietary effects in the Atlantic Region): population-based observational study to monitor dietary intakes and purchasing during COVID-19 in four Atlantic Canadian provinces

IntroductionPoor diet is a leading preventable risk for the global burden of non-communicable disease. Robust measurement is needed to determine the effect of COVID-19 on dietary intakes and consumer purchasing,...

535 Pre-operative Expectations, Post-operative Satisfaction and Patient Directed Priorities for Clinical Burn Research

IntroductionPatients receiving split thickness skin grafting due to deep burns are left with scarring and chronically dysfunctional skin at the graft site. Given evidence that patients’ pre-operative expectations mediate post-operative outcomes and satisfaction, we sought to describe burn patients’ experience, expectations, and satisfaction with their skin graft, and their views towards a future cell-based clinical trial to improve their graft, over time. We also aimed to identify graft outcome measures for use in future studies.MethodsThis study was approved by our university's research ethics board. All participants provided written and informed consent. Data were collected via patient questionnaires pre-operatively, one, and three months post-operatively.ResultsMost patients had small burns. Expectations of graft function were consistent pre- and post-operatively. Expectations of graft appearance showed significant decrease over time (β 1 = -0.290, p = 0.008). Significant improvements in skin function (β 1 = 0.579, p = 0.000) and appearance (β 1 = 0.247, p = 0.025) at the wound site during recovery were observed, although patients noted great difference between grafted and normal skin. Patient satisfaction with their graft did not change significantly over time. Patients were willing to participate in a cell-based clinical trial that may improve graft symptomology. They prioritized diminished scarring, redness, and improved sensation and elasticity as the most salient aspects of grafts to be enhanced by cell-based therapy.ConclusionsPatient graft concerns changed over time; outcome measures in trials advancing skin grafting should reflect chronic, patient prioritized limitations.

The use of a guided peer review assessment for investigative interviewers of child witnesses

PurposeInvestigative interviewers assess their colleagues' interviews (‘peer review’) as a necessary part of their practice, and for their self-development. Yet, there is little guidance around what the process involves and how they might do it. Research suggests that effective peer review is supported by using guidance material. The goal of the present work was to describe the use of such a guide by a group of professionals who regularly conduct investigative interviews with children, to share what was learned with other professionals seeking to create a formalized peer review process.Design/methodology/approachSixty US child witness interviewers completed a guided peer review assessment of an anonymous interview, as an assignment at the conclusion of an 18-hour training program that focused on developing their interviewing skills. They consented to the use of their learning data in research, and the research was approved by the university's research ethics board. Peer reviews were coded for the extent to which they used the guide to support their evaluations, and the overall quality of the review to assess the utility of the guide in supporting them to conduct effective assessments.FindingsIn general, the guide and instructions for providing feedback were moderately effective in supporting the peer assessments, but results suggested specific training in how to deliver peer review would be useful.Practical implicationsThrough this process, the authors identified components that would be helpful to further increase the efficacy of peer review.Originality/valueThe aim of this work was to spark a greater conversation among practitioners and academics about professionalizing the peer review process and aiding interviewers to develop peer review tools that would support their continued growth. The authors conclude with five key tips for professionals that stem from the experiences creating and evaluating the guide in combination with existing literature and three areas for future investigation.

When COVID-19 delays the management of an urgent heart condition: A rare case of a spontaneous dissection of two coronary arteries.

Some severe life‐threatening conditions could be misdiagnosed during the current COVID‐19 pandemic.

Self-control in old age: A grounded theory study.

Self-control is associated with multiple positive outcomes. There are several studies on self-control, yet no literature describing the mechanism of self-control in old age. This study aims to develop a substantive theory on the exercise of self-control in old age. Grounded Theory methodology developed by Glaser & Strauss was utilized in the conduct of this study with ten (10) older adults as participants following the set of inclusion and exclusion criteria. Individual in-depth interviews of 30-45 minutes were observed to gather the needed verbatim narrative responses from each participant after careful consideration of the ethical procedures approved by the University research ethics board. Major themes with their respective sub-themes were generated after rigorous analysis of the participants' responses following the steps provided by Glasser & Strauss in conducting grounded theory studies. This study resulted in the formulation of three propositions such as: (1) Older adults exercise self-control differently, (2) several personal motivations are involved in the exercise of self-control, and (3) the exercise of self-control leads to life satisfaction. From the propositions emerged the Theory of Self-control in Old age, which states that the process of self-control encompasses the human capability of exercising self-restraint to overrun different types of desires, passions, and temptations. The theory posits that older adults vary in their exercise of self-control depending upon their personal motivations. The theory also assumes that the exercise of self-control results in life satisfaction as displaying self-control is attributed to a host of positive life outcomes. The present study has important implications in the field of gerontology and health care services since the older population is growing, and so does the demand for health care services. The need to understand the choices and decisions of older adult clients is fundamental in individualizing the health care services that may be designed and provided for them.

Research from the Heart: Friendship and Compassion as Personal Research Values

ABSTRACT This article reflects on the author’s efforts to center friendship and compassion as in research that is highly personal and intimate, as well as on the ways that friendship and compassion, as research values, can sit in tension with university research ethics board (REB) approval processes. The article includes three research case studies to explore how procedural ethics review by REBs overlooks certain types of research harms and obscures the important role of relationships in determining research outcomes. The article concludes with a call for research from the heart.

6-Month Follow Up of Hospitalised COVID-19 Patients: A Nationwide Cohort Study of 8679 Patients in Germany

Background: COVID-19 frequently necessitates inpatient treatment and inpatient mortality is high. Less is known about long-term outcomes in terms of mortality and readmissions. We provide a detailed account of hospitalised COVID-19 patients until 180 days after their initial hospital admission. Methods: An observational study with claims data from the German Local Health Care Funds of adult patients hospitalised in Germany between Feb 1 and April 30, 2020 with PCR-confirmed COVID-19 and a related principal diagnosis, for whom follow-up data for 180 days after admission or until death was available. A multivariable logistic regression model identified independent risk factors for 180-day mortality. Findings: Of 8679 patients with a median age of 72 years, 2161 (24·9%) died during the index hospitalisation. 30-day mortality was 23·9% (2073/8679), 90-day 27·9% (2425/8679), and 180-day 29·6% (2566/8679). The latter was 52·3% (1472/2817) for patients aged ≥80 years, 23·6% (1621/6865) if not ventilated during index hospitalisation but 53·0% in those ventilated invasively (853/1608). Risk factors for 180-day mortality included coagulopathy, BMI ≥ 40 and age, while female sex was a protective factor beyond fewer prevalence of comorbidities. Of 6235 patients discharged alive, 1668 patients were readmitted a total of 2551 times within 180 days, resulting in an overall readmission rate of 26·8%. Interpretation: 180 day-follow up data of hospitalised COVID-19 patients in a nationwide cohort representing almost one-third of the German population show considerable long-term mortality and readmission rates, especially among patients with coagulopathy, whereas women have a profound and long-lasting better clinical outcome compared to men. Funding: Funding Institutional support and physical resources were provided by the University Witten/Herdecke and Kliniken der Stadt Köln, the Federal Association of the Local Health Care Funds and the Technical University of Berlin. The latter also received a grant from the Berlin University Alliance (112_PreEP_Corona). Declaration of Interest: Dr. Busse reports grants from Berlin University Alliance, during the conduct of the study; grants from Federal Ministry of Research and Education, grants from Federal Ministry of Health, grants from Innovation Fonds of the Federal Joint Committee, grants from World Health Organization, outside the submitted work, Dr. Schuppert reports grants from Bayer AG, outside the submitted work. Dr. Karagiannidis reports personal fees from Maquet, personal fees from Xenios, personal fees from Bayer, non-financial support from Speaker of the German register of ICUs, grants from German Ministry of Research and Education, during the conduct of the study. Christian Günster, Melissa Spoden, Steffen Weber-Carstens, Gerhard Schillinger, Tanja Rombey and Dr. Hofmann have nothing to disclose. Ethical Approval: The study was approved by the Ethics Committee of the Witten/Herdecke University (research ethics board number 92/2020).<br>

Risk Factors for the Development of Skin Cancers in Patients with Chronic Lymphocytic Leukemia: A Retrospective Cohort Study

Introduction: Individuals with chronic lymphocytic leukemia (CLL) are often immunosuppressed and at increased risk of infection and secondary malignancies. The primary aim of this study was to determine the incidence of skin cancer amongst the CLL population at Kingston Health Sciences Centre (KHSC), Ontario, Canada. Secondly, we sought to identify the risk factors associated with the development of skin cancer in CLL patients. Methods: Consecutive patients seen at KHSC with a diagnosis of CLL between 2014 January 1 and 2019 December 31 formed the primary study cohort. KHSC serves a region of ~ 550,000 including a high proportion of older individuals and those living in rural areas. Approval was provided by Queen's University Research Ethics Board. Four independent reviewers conducted retrospective electronic chart review, initially in duplicate with review of any areas of discrepancy to ensure a standardized approach. Data collected included age, sex, CLL date of diagnosis, stage, genetics and treatment; histological diagnoses of other cancers (skin and other), smoking status (ever/never) and date of last follow up or death. The primary outcome was the development of the first skin cancer (squamous cell carcinoma, basal cell carcinoma, melanoma, or sarcoma) confirmed via pathology reports that are available in our local institution. All statistical analysis was performed using SAS Enterprise v. 7.15. Categorical variables were compared using chi-square or Fisher exact tests, medians using Wilcoxon and Mann-Whitney tests, and continuous variables using t-tests. Risk factors for development of skin cancer were assessed using multivarable Cox-proportional hazard models. Results: Of the total cohort of 377 individuals with CLL, 251 (67%) were male. Median age at diagnosis of CLL was 65 years (range 36 - 93 years of age). Median follow-up from the time of CLL diagnosis was 6.5 years (range 0.27 - 30.98). Of these, 80 individuals (21.2%) developed at least one skin cancer after their diagnosis of CLL, with an age-adjusted incidence of 16.96/1000 patient years (95% CI 12.5 - 23). Among the 297 who did not develop skin cancer post-CLL diagnosis, 13 individuals who had documented skin cancer pre-CLL diagnosis only, are included in the non-skin cancer group (Figure 1). Females had a lower incidence of skin cancer compared with males (63 males versus 17 females, p=0.009). There was no difference between the groups based on Rai stage at diagnosis, smoking history, or IGHV /p53 status. Individuals treated with ibrutinib had a lower incidence of skin cancer (3 versus 49, p=0.002). Development of skin cancer was associated with development of other invasive tumours including CLL transformation (p=0.001) (Table 1). Conclusion: Limitations of this study include its small size, and single institution setting. Our data likely reflect a conservative estimate as skin cancers may be diagnosed outside of the institution, and not all CLL is treated at tertiary care centres. Consistent with other studies we found that males with CLL are at increased risk of developing skin cancer, as compared to females. Individuals with CLL and skin cancer were more likely to develop another malignancy or Richter's transformation. The finding of lower incidence of skin cancer with ibrutinib treatment is novel; further investigation in larger populations is needed to determine if it may offer a protective effect. Disclosures Asai: Sanofi Canada: Honoraria, Research Funding; AllerGen NCE: Research Funding; Pfizer: Honoraria, Research Funding; Janssen: Honoraria; Leo Pharma: Honoraria; Eli Lilly: Honoraria; Novartis: Honoraria; Abbvie: Honoraria, Research Funding; Canadian Institutes of Health Research: Research Funding. Hay:Roche: Research Funding; Janssen: Research Funding.

“Journey of Uncertainties:” Nature of Transitioning among Persons Living with Undetectable HIV


 Introduction: The management of persons living with HIV gears towards making that person “seronegative,” undetectable in screening and practically with almost no risk of transmitting the disease. Although the trajectory of this management is clear, the process by which the person living with HIV transition from being seropositive to seronegative remains to be explored. There remains to be a paucity of research on the nature of transitioning among seronegative persons living with HIV especially from the lens of an Asian nation.
 Methodology: This study explored the nature of transitioning among nine (9) seronegative persons living with HIV. Grounded on the Rogerian Science of Unitary Human Being as its philosophical underpinning and Gadamerian interpretative phenomenology as its approach, nine (9) informants were selected with the following criteria: They are 1) Persons living with HIV for at least 2 years; 2) Seronegative for at least a year during the time of the interview, and 3) Willing to articulate and share their experiences. After obtaining approval from the University Research Ethics Board, multiple in-depth interviews, story-telling sessions, and photo-elicitation were utilized to gather the informants' narratives.
 Findings: After a series of reflective analyses, the following nature of transitioning was identified: (1) transitioning as a conscious deliberate choice, (2) transitioning as an unpredictable struggle of being, and (3) transitioning as seeking a personal sense of normalcy. These transition patterns reflect the moment to moment deliberate choice of existence by the informants. The transition moments are appreciated thru the lens of unpredictability and internal struggles as they try to create a sense of normalcy amidst their transitioning situations.
 Implications: Insights from this study suggest that though the process of transitioning among informants seems varied, the core patterns of deliberateness, unpredictability, and sense of normalcy cut across their stories. Persistent support from peers and family sustained counseling from diagnosis to being seronegative and health teaching focusing on risky behavior while transitioning are implied techniques to provide support during their transitioning process. The sense of immediacy and genuine presence from health care providers caring for these persons seems to be appreciated as a supportive mechanism of their transitioning journey.

Practice patterns among early-career primary care (ECPC) physicians and workforce planning implications: protocol for a mixed methods study

IntroductionCanadians report persistent problems accessing primary care despite an increasing per-capita supply of primary care physicians (PCPs). There is speculation that PCPs, especially those early in their careers, may now...