Kerry McBrien

Background: Symptom diaries are widely used in acute respiratory infection trials to capture patient-reported symptom severity and recovery. Longer questionnaires may provide a more complete clinical picture but can increase participant burden and reduce adherence. Evidence directly comparing long and short formats within the same trial is limited. Objective: To compare adherence, symptom trajectories, agreement between recovery measures, and predictive performance for recovery-related outcomes between a short and long symptom diary in an outpatient SARS-CoV-2 trial. Methods: This secondary analysis of the CanTreatCOVID trial compared a 9-item Abbreviated Diary and a 34-item FLU-PRO Plus Diary over 14 days in non-hospitalized participants with confirmed SARS-CoV-2 infection. Outcomes included diary initiation, completion, completion rate, compliance, symptom trajectories, agreement between recovery outcomes, and predictive performance. Analyses used logistic regression, generalized estimating equations, survival models, and predictive modelling. Results: Of 712 participants, 638 used the Abbreviated Diary and 74 the FLU-PRO Plus Diary. Baseline characteristics were similar between groups. Diary type was not significantly associated with diary initiation or full 14-day compliance, whereas treatment assignment was associated with higher adherence ( p < 0.0001). Completion rates were slightly higher in the Abbreviated group (88.3% vs. 84. 8%), but differences were not statistically significant. Agreement between “feeling recovered” and “return to usual health” was strong to excellent (κ = 0.83–0.88), while agreement with “return to usual activities” was moderate (κ = 0.52–0.65). Predictive models performed well for both diaries (AUCs 0.87–0.94), with only marginal gains from including the extended FLU-PRO Plus items. Conclusion: In this outpatient SARS-CoV-2 trial, no statistically significant differences in adherence, symptom trajectories, or predictive performance were detected between abbreviated and extended symptom diaries. These analyses were not designed or powered as equivalence tests; the absence of statistically significant differences should not be interpreted as evidence of equivalence between diary formats. Future research should extend follow-up beyond 14 days to capture longer-term patterns and test diary performance in more diverse and digitally underserved populations.

Purpose: To understand how the Philips PAP device recall affected patient experiences, clinical practice, and health system responses. Methods: From November 2022 to August 2023, we interviewed individuals with OSA, physicians, respiratory therapists and health system leaders. We also received emailed responses from Health Canada. Interviews explored participants’ experiences with the recall announcement and communication, their own responses and perceptions of actions taken by others, the overall impact of the recall and suggestions for improving future recall processes. Interviews were analyzed using an inductive thematic approach. Results: We interviewed 47 participants (16 individuals with OSA, 10 physicians, 17 public or private respiratory therapists, five health system leaders). Themes were organized into four domains: recall communication, execution, participant experiences, and the policy and regulatory context. Participants were confused due to inadequate information from Philips throughout the process. The burden of notifying patients and tracing devices mostly fell to healthcare providers and vendors, while replacement efforts were disorganized and frustrating. Individuals with OSA experienced emotional distress over therapy decisions and difficulties navigating the recall. Healthcare providers described moral distress from being unable to support patients adequately, and vendors faced additional logistical and financial strain. While regulatory authorities reported that Philips followed standard procedures, participants expressed a loss of trust in both the manufacturer and oversight systems. Conclusions: Interviews revealed that poor communication and execution of the Philips recall caused confusion, frustration and significant emotional and financial burden. Collaborative, context-specific strategies are required to improve future recalls.

Rationale: Obstructive sleep apnea (OSA) is a common, treatable chronic disease with significant health and societal consequences. Many patients face barriers to care due to systemic inequality, poverty, and other contributors to social vulnerability, leading to delayed diagnosis and more severe disease at presentation. Several studies have examined the impacts of social vulnerability on OSA severity using individual-level factors. However, there is comparatively limited work examining how neighbourhood-level indicators may influence OSA severity. This study aimed to determine whether social vulnerability, measured using a neighbourhood-level multidimensional index, is associated with OSA severity at referral to a tertiary sleep centre. Methods: We conducted a retrospective observational study of adult patients referred to an academic hospital in Calgary, Canada for evaluation of OSA between November 2016 and November 2019. Patient data were linked using residential postal codes to the Canadian Index of Multiple Deprivation (CIMD), a census-based tool designed to reflect dimensions of social vulnerability in Canadian populations. CIMD divides social vulnerability into four dimensions including residential instability, ethnocultural composition, economic dependency, and situational vulnerability. We employed both linear and logistic mixed-effects models to assess the impact of neighbourhood-level social vulnerability on sleep apnea severity, using postal code as the grouping variable. OSA severity was based on home sleep apnea test (HSAT) derived oxygen desaturation index (ODI). Secondary outcomes included severe OSA (ODI ≥ 30), sleepiness based on Epworth Sleepiness Scale (ESS), and severe sleepiness (ESS > 15). Results: The study included 2,232 patients, 80% of whom had at least mild OSA. ODI was positively associated with situational vulnerability ( p < 0.01) and inversely associated with ethnocultural composition ( p < 0.01), though both associations lost significance after adjusting for BMI. ESS was independently associated with situational vulnerability ( p < 0.01) and inversely with ethnocultural composition ( p = 0.01), independent of BMI and ODI. Severe sleepiness was associated with situational vulnerability ( p < 0.01) and residential instability ( p = 0.02). Conclusion: Living in a socially deprived area was associated with OSA severity at time of referral, though this relationship appeared to be mediated by BMI. Deprivation dimensions were independently associated with sleepiness, highlighting the broader impact of social-related factors on sleepiness. These findings demonstrate the complex interplay between social vulnerability and sleep disorders and suggest that composite indices like the CIMD can enhance our understanding of these relationships.

Background/Objective: Barriers in access to care have prompted development of innovative care delivery models for patients with obstructive sleep apnea (OSA). One such innovation is management of uncomplicated OSA by primary care providers (PCPs), which reserves specialist capacity for more complex patients. We developed a clinical guideline and subsequently, an online clinical pathway to support PCPs in OSA management. We aimed to evaluate the impact of these initiatives on PCP behaviour by assessing changes in the complexity of newly referred patients. Methods: We compared data for new OSA referrals to the Foothills Medical Centre Sleep Centre in Calgary, Canada, received during three distinct referral periods: prior to the clinical guideline (November 2016 – March 2017; Period 1), after implementation of the clinical guideline (April 2017 – November 2018; Period 2), and after publication of the online primary care pathway (December 2018 – November 2019; Period 3). The primary outcome was OSA severity as defined by the oxygen desaturation index (ODI) on home sleep apnea testing performed at the time of referral. Secondary outcomes included severity of daytime sleepiness and proportion of patients with severe OSA or severe daytime sleepiness at the time of referral. Multivariable linear and logistic regression models were constructed to quantify the associations between study outcomes and Period after adjustment for baseline covariates. Results: Among the 2489 patients with sleep study data available, patients referred in Period 3 had more severe OSA (ODI, mean nocturnal oxygen saturation, proportion with severe OSA) compared to patients referred in earlier Periods. Severity of sleepiness did not increase across Periods. In multivariable analysis adjusting for demographics and comorbidities, ODI was significantly associated with Period (regression coefficient 1.70 (0.39, 3), p = 0.011) but severe OSA was not (odds ratio 1.17 (0.99, 1.39), p = 0.069). Conclusions: OSA severity increased following implementation of educational resources to support primary care OSA management. These findings suggest that with appropriate supports, PCPs may be more comfortable managing less severe OSA patients independently and only refer more severe cases for specialist consultation.

Background: Diabetes, cardiovascular disease, and chronic kidney disease are associated with high morbidity and costs of care. Medications can reduce long-term complications but may contribute to complications such as hypoglycemia and acute kidney injury during acute illnesses. Sick day medication guidance (SDMG) could help prevent these adverse events, but evidence for effective strategies to deliver this guidance is lacking. Objective: We iteratively designed and developed a digital prototype user interface (UI) to deliver SDMG for patient self-management. The application, called “Preventing medication complications during AcUte illness through Symptom Evaluation and sick day guidance” (PAUSE), delivers personalized knowledge and self-management guidance directly to patients to enhance medication self-management during acute illness, with the goal of reducing preventable emergency visits and hospitalizations and improving patient outcomes during acute illness. Methods: Using a human-centered design (HCD) approach, we conducted iterative heuristic evaluation and usability testing paired with prototype revisions. Heuristic evaluation involved our team members evaluating the prototype’s UI against established criteria. We also conducted formative usability testing with 6 patients (including a patient-caregiver dyad) to provide subjective lived experience perspectives. We analyzed data deductively and pragmatically to rapidly inform subsequent iterations. Results: We identified 21 and 44 design issues through heuristics evaluation and usability testing, respectively. The development team iteratively revised the PAUSE UI prototype between evaluations, with the final design providing key user flows and integrated supports and reminders for acting on severe acute illness situations that recommend pausing certain medications. Conclusions: Using an iterative HCD approach, we designed and developed a digital health application to deliver SDMG for patient self-management. We addressed feasible technical and workflow barriers using iterative heuristic evaluations and usability testing resulting in a refined SDMG self-management prototype app for patients taking medications commonly used to treat diabetes, cardiovascular disease, and chronic kidney disease. Further research is needed to test the effectiveness of the current PAUSE app in helping people with these chronic conditions self-manage their medications during acute illness and evaluate the feasibility of integrating the app into community-based chronic disease care.

Objectives: This environmental scan has two aims. The first is to identify wholistic, physical activity (PA)–based wellness interventions for Indigenous women in Canada through the completion of a scoping review of published and grey literature and key informant interviews. The second is to identify promising practices and potential barriers to intervention development and delivery. Methods: Components of the environmental scan included (1) the creation of a logic model in collaboration with a community-based Advisory Group, (2) a scoping review of wholistic PA-based wellness interventions between January 1990 and March 2022, (3) key informant interviews of individuals involved in PA-based wellness programming, and (4) thematic analysis of promising practices, enablers, and barriers found in both the articles and interviews. Synthesis: The scoping review identified 16 interventions. Through key informant interviews, 6 additional interventions were identified. Programs were largely community-based and culturally appropriate. Financial factors were the most common barrier. Walking as a form of PA was commonly employed and key informant interviews highlighted the importance of exploring on-the-land activities, group activities, and the incorporation of all elements of wholistic health (mental, physical, spiritual, and emotional). Only one study employed Indigenous research methods. Conclusion: There is limited published literature and a dearth of PA-based, wholistic health programs for Indigenous women in Canada. More programming and research are required to address the unique health needs of Indigenous women and mitigate the legacy impacts of colonization on health.

Background: Care for mild to moderate chronic kidney disease (CKD) entails self-management from patients and clinical support from primary care and nephrology. To address the gap in self-management resources, My Kidneys My Health was codeveloped to support patients with CKD. Health care providers play a critical role in the implementation of patient resources; however, there is a gap in understanding providers’ perspectives in this role. Objective: This study develops and evaluates strategies to implement My Kidneys My Health into routine primary care and general nephrology clinical care. Methods: Health care providers working in Alberta, Canada, who support patients with CKD were invited to participate in our multistep study, guided by the Quality Implementation Framework. In step 1, we followed qualitative descriptive methodology to identify barriers and enablers to implementation using a directed content analysis and a deductive coding approach. Participants were invited to complete semistructured interviews from October 2021 to May 2022. In step 2, we identified, prioritized, codeveloped, and launched implementation strategies based on step 1 results using behavior change theory. Participants were invited to use the materials during the implementation period (May to October 2022). Website engagement was tracked through Google Analytics and document distribution tracking. In step 3, we conducted follow-up interviews with participants (October to December 2022) to evaluate implementation based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, following the same qualitative approach as step 1. Effectiveness was out of the scope of this study. Results: A total of 16 health care providers participated in step 1 qualitative interviews (8 from nephrology clinics and 5 from primary care or nonambulatory care). Participants shared an individual-level readiness and interest in sharing My Kidneys My Health with their patients. The key barriers to implementation included awareness, memory, time, motivation, and innovation accessibility. Implementation strategies were co-designed and implemented by step 1 participants (ie, educational sessions and materials, reminders, and implementation coaching). Notably, 9 health care providers participated in step 3 qualitative interviews. Participants shared their approach to tailoring implementation based on their patients and integrating the resource into their current practices. The resources developed were highly used by participants, with positive feedback on their usability and accessibility. Participants expressed motivation to continue sharing My Kidneys My Health; however, awareness and accessibility require further adaptations that can improve sustainability of implementation. Our rigorous approach allowed us to address behavior change and sustainability of implementation of My Kidneys My Health, as well as identify appropriate and tailored implementation strategies. Conclusions: There is a readiness to implement self-management supports for patients with early-stage CKD. A theory-informed approach and strategic implementation strategies can support sustainability.

BACKGROUND Diabetes, cardiovascular disease, and chronic kidney disease are associated with high morbidity and costs of care. Medications can reduce long-term complications but may contribute to complications such as hypoglycemia and acute kidney injury during acute illnesses. Sick day medication guidance (SDMG) could help prevent these adverse events, but evidence for effective strategies to deliver this guidance is lacking. OBJECTIVE We iteratively designed and developed a digital prototype user interface (UI) to deliver SDMG for patient self-management. The application, called “Preventing medication complications during AcUte illness through Symptom Evaluation and sick day guidance” (PAUSE), delivers personalized knowledge and self-management guidance directly to patients to enhance medication self-management during acute illness, with the goal of reducing preventable emergency visits and hospitalizations and improving patient outcomes during acute illness. METHODS Using a human-centered design (HCD) approach, we conducted iterative heuristic evaluation and usability testing paired with prototype revisions. Heuristic evaluation involved our team members evaluating the prototype’s UI against established criteria. We also conducted formative usability testing with 6 patients (including a patient-caregiver dyad) to provide subjective lived experience perspectives. We analyzed data deductively and pragmatically to rapidly inform subsequent iterations. RESULTS We identified 21 and 44 design issues through heuristics evaluation and usability testing, respectively. The development team iteratively revised the PAUSE UI prototype between evaluations, with the final design providing key user flows and integrated supports and reminders for acting on severe acute illness situations that recommend pausing certain medications. CONCLUSIONS Using an iterative HCD approach, we designed and developed a digital health application to deliver SDMG for patient self-management. We addressed feasible technical and workflow barriers using iterative heuristic evaluations and usability testing resulting in a refined SDMG self-management prototype app for patients taking medications commonly used to treat diabetes, cardiovascular disease, and chronic kidney disease. Further research is needed to test the effectiveness of the current PAUSE app in helping people with these chronic conditions self-manage their medications during acute illness and evaluate the feasibility of integrating the app into community-based chronic disease care.

BACKGROUND Care for mild to moderate chronic kidney disease (CKD) entails self-management from patients and clinical support from primary care and nephrology. In response to a gap in resources for this population, My Kidneys My Health was co-developed to support self-management of CKD. While this is a patient-facing tool, health care providers play a critical role in the implementation of patient resources OBJECTIVE This study develops and evaluates strategies to implement My Kidneys My Health into routine primary care and general nephrology clinical care. METHODS Health care providers working in Alberta, Canada who support patients with CKD were invited to participate in our multi-step study, guided by the Quality Implementation Framework. Step 1: we followed qualitative descriptive methodology to identify barriers and enablers to implementation using a directed content analysis and a deductive coding approach. Participants were invited to complete semi-structured interviews from October 2021 to May 2022. Step 2: we identified, prioritized, co-developed, and launched implementation strategies based on behaviour change theory. Participants from Step 1 were invited to use the materials during the implementation period (May to October 2022). Utilization was tracked through Google Analytics and document distribution tracking. Step 3: we conducted follow-up interviews with participants (October to December 2022) to evaluate implementation based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, following the same qualitative approach as Step 1. Effectiveness was out of scope of this study. RESULTS 14 health care providers participated in Step 1 qualitative interviews (42.9% from nephrology clinics, 35.7% from primary care). Participants shared an individual-level readiness and interest in sharing My Kidneys My Health with their patients. The key barriers to implementation included awareness, memory, time, motivation, and innovation accessibility. Implementation strategies were co-designed and implemented by Step 1 participants (i.e., educational sessions and materials, reminders, implementation coaching). 9 health care providers participated in Step 3 qualitative interviews. Participants shared their approach to tailoring implementation based on their patients and integrating the resource into their current practices. The resources developed were highly utilized by participants, with positive feedback on their usability. Participants expressed motivation to continue sharing My Kidneys My Health; however, awareness and accessibility require further adaptations can improve sustainability of implementation. Our rigorous approach allowed us to address behaviour change and sustainability of implementation of My Kidneys My Health, as well as identifying appropriate and tailored implementation strategies CONCLUSIONS There is a readiness to implement self-management supports for patients with early-stage CKD. A theory-informed approach and strategic implementation strategies can support sustainability. CLINICALTRIAL n/a INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1007/s43477-022-00038-3