Exploring patient perspectives on EQ-5D-5L data visualization within an individualized decision aid for total knee arthroplasty (TKA) in Alberta, Canada.

BACKGROUND: Decision aids can help patients set realistic expectations. In this study, we explored alternative presentations to visualise patient-reported outcomes (EQ-5D-5L) data within an online, individualized patient decision aid for total knee arthroplasty (TKA) that, in part, generates individualized comparisons based on age, sex and body mass index, to enhance usability prior to implementation into routine clinical practice. METHODS: We used data visualization techniques to modify the presentation of EQ-5D-5L outcomes data within the decision aid. The EQ-5D-5L data was divided into two parts allowing patients to compare themselves to similar individuals (1) pre-surgery and (2) 1-year post-surgery. We created 2 versions for each part and sought patient feedback on comprehension, usefulness, and visual appeal. Patients from an urban orthopedic clinic were recruited and their ratings and comments were recorded using a researcher-administered checklist. Data were managed using Microsoft Excel, R version 3.6.1 and ATLAS.ti V8 and analyzed using descriptive statistics and directed content analysis. RESULTS: A total of 24 and 25 patients participated in Parts 1 and 2, respectively. Overall, there was a slight preference for Version 1 in Part 1 (58.3%) and Version 2 in Part 2 (64%). Most participants demonstrated adequate comprehension for all versions (range 50-72%) and commented that the instructions were clear. While 50-60% of participants rated the content as useful, including knowing the possible outcomes of surgery, some participants found the information interesting only, were unsure how to use the information, or did not find it useful because they had already decided on a treatment. Participants rated visual appeal for all versions favorably but suggested improvements for readability, mainly larger font and image sizes and enhanced contrast between elements. CONCLUSIONS: Based on the results, we will produce an enhanced presentation of EQ-5D-5L data within the decision aid. These improvements, along with further usability testing of the entire decision aid, will be made before implementation of the decision aid in routine clinical practice. Our results on patients' perspectives on the presentation of EQ-5D-5L data to support decision making for TKA treatments contributes to the knowledge on EQ-5D-5L applications within healthcare systems for clinical care.

Effectiveness of RADAR on diabetes processes of care for First Nations communities in Alberta, Canada.

The epidemic of type-2 diabetes in First Nations communities is tragic. Culturally-appropriate approaches addressing multiple components, focusing beyond glycemic control, are urgently needed. Using an intention-to-treat framework, 13 processes of care indicators were assessed to compare proportions of patients who received care at baseline relative to 2-year follow-up. Clinical improvements were demonstrated across major process of care indicators (e.g. screening, education, and vaccination activities). We found RADAR improved reporting for most diabetes processes of care across seven FN communities and was effective in supporting diabetes care for FN communities, in Alberta Canada.

Effectiveness of RADAR: An Innovative Model to Organize Diabetes Care in First Nations Communities.

Challenges exist for the management of diabetes care in First Nations populations. RADAR (Reorganizing the Approach to Diabetes through the Application of Registries) is a culturally appropriate, innovative care model that incorporates a disease registry and electronic health record for local care provision with remote coordination, tailored for First Nations people. This study assessed the effectiveness of RADAR on patient outcomes and diabetes care organization in participating communities in Alberta, Canada. It revealed significant improvements in outcomes after 2 years, with 91% of patients achieving a primary combined end point of a 10% improvement in or persistence at target for A1C, systolic blood pressure, and/or LDL cholesterol. Qualitative assessment showed that diabetes care organization also improved. These multimethod findings support tailored diabetes care practices in First Nations populations.

Mental health experiences with COVID-19 public health measures in an Alberta First Nations Community.

BACKGROUND: First Nations (FN) people of Canada experience health, social, and systemic inequities due to colonization. Consequently, COVID-19 has placed further mental health stress on people related to personal finances, employment security and worry over infection, resulting in exacerbated effects of unresolved past medical and physical traumas. This study aims to understand the experiences related to mental health in an Alberta FN community during the early stages of the pandemic. METHODS: In partnership with FN leadership, the study implemented an online cross-sectional survey. Adults from a large FN community in Alberta, Canada, were asked to complete a survey, including two mental health-related screening questionnaires: (1) Generalized Anxiety Disorder-2 item; and (2) Patient Health Questionnaire-2 item. In addition, respondents could provide responses to open-ended questions about their experiences. RESULTS: Among 106 respondents, 95 (89.6%) finished the survey; 18% of adults screened positive for depressive symptoms (score of 3 or greater) and reported difficulty following public health advice for using hand sanitizer, maintaining social distancing, or self-isolating. 21% of adults screened positive for symptoms of anxiety (score of 3 or greater) and reported difficulty maintaining social distance, self-isolating, obtaining food and clothing, or meeting other basic living requirements. CONCLUSIONS: FN communities may be disproportionately affected by COVID-19, and may experience exacerbated symptoms of anxiety, depression and overall poor mental health and well-being. Additional supports and services, including for mental health, should be considered for FN in the context of COVID-19 public health measures. HIGHLIGHTS: The COVID-19 pandemic has brought upon increased stress and accompanying symptoms of anxiety and depression for a First Nations community in Alberta. Studies, such as this one, that characterize the influence of the COVID-19 pandemic on mental health among First Nations people, are urgently needed because of increasing demands on healthcare systems due to the pandemic and potential delays in the care of patients living with pre-existing mental health conditions. There is an opportunity to capitalize on First Nations people's experiences of post-traumatic growth proactively supporting/maintaining their well-being and possibly the development of community-based mental health interventions and supports.

Appropriateness of COVID-19 public health guidelines for an Alberta First Nations community.

OBJECTIVES: The First Nations people experience significant challenges that may influence the ability to follow COVID-19 public health directives on-reserve. This study aimed to describe experiences, perceptions and circumstances of an Alberta First Nations community, related to COVID-19 public health advice. We hypothesized that many challenges ensued when following and implementing advice from public health experts. METHODS: With First Nations leadership and staff, an online cross-sectional survey was deployed between April 24 and June 25, 2020. It assessed the appropriateness of public health advice to curb COVID-19 within this large First Nations community. Both quantitative and qualitative data were captured and described. RESULTS: A total of 106 adults living on-reserve responded; over 80% were female. Difficulty accessing food was significant by employment status (p = 0.0004). Those people with lower income found accessing food (p = 0.0190) and getting essential medical care (p = 0.0060), clothing (p = 0.0280) and transportation (p = 0.0027) more difficult. Some respondents described lost income associated with COVID-19 experiences, as well as difficulties accessing essential supplies. Respondents found "proper handwashing" most easy (98%) and "keeping a distance of 2 m from others" most difficult (23%). Many respondents found following public health advice within their personal domain easy and put "family safety" first but experienced some difficulties when navigating social aspects and obligations, particularly when unable to control the actions of others. People stated wanting clear information, but were sometimes critical of the COVID-19 response. CONCLUSION: First Nations people face many additional challenges within the COVID-19 response, driven in part by ongoing issues related to significant societal, economic, and systemic factors.

RéSUMé: OBJECTIFS: Les Premiers Peuples connaissent d'importantes difficultés qui peuvent nuire à la capacité de suivre les directives de santé publique sur la COVID-19 dans les réserves. Notre étude visait à décrire les expériences, les perceptions et la situation d'une Première Nation de l'Alberta en lien avec les consignes de santé publique sur la COVID-19. Nous avons postulé que de nombreuses difficultés s'ensuivent lorsque les conseils des spécialistes de la santé publique sont suivis et appliqués. MéTHODE: Avec les dirigeants et le personnel de la Première Nation, nous avons mené un sondage transversal en ligne entre le 24 avril et le 25 juin 2020. Le sondage évaluait la pertinence des consignes de santé publique pour contenir la COVID-19 dans cette grande communauté. Des données quantitatives et qualitatives ont été saisies et décrites. RéSULTATS: En tout, 106 adultes vivant dans la réserve ont répondu; plus de 80 % étaient des femmes. Les difficultés d'accès aux aliments selon la situation d'emploi étaient significatives (p = 0,0004). Les personnes à faible revenu trouvaient plus difficile d'accéder aux aliments (p = 0,0190) et d'obtenir des soins médicaux essentiels (p = 0,0060), de se procurer des vêtements (p = 0,0280) et de trouver de moyens de transport (p = 0,0027). Certains répondants ont fait état de pertes de revenus associées à leurs expériences de la COVID-19, et de difficultés d'accès aux fournitures essentielles. Les répondants ont trouvé que « bien se laver les mains ¼ était la consigne la plus facile à respecter (98 %), et que « rester à 2 mètres les uns des autres ¼ était la plus difficile (23 %). De nombreux répondants ont trouvé facile de respecter les consignes de santé publique dans leur domaine personnel et d'accorder la priorité à « la santé familiale ¼, mais ont éprouvé des difficultés à négocier les obligations et aspects sociaux, particulièrement lorsqu'ils ne pouvaient pas contrôler les actions des autres. Les gens ont dit vouloir des informations claires, mais ont parfois critiqué la riposte à la COVID-19. CONCLUSION: Les Premiers Peuples font face à de nombreuses difficultés supplémentaires dans le cadre de la riposte à la COVID-19; ces difficultés résultent en partie de problèmes persistants liés à d'importants facteurs sociétaux, économiques et systémiques.

Sleep Health in Male-dominated Workplaces: A Qualitative Study Examining the Perspectives of Male Employees.

OBJECTIVE: The purpose of this qualitative study was to explore working men's perspectives about sleep health and the intersecting influences of gender and work, describing participant's views on current and potential programming and organizational support to promote sleep health. METHODS: Twenty men employed in male-dominated industries in the north-central region of Alberta, Canada, participated in 4 consultation group discussions addressing motivators, facilitators and barriers to sleep health. RESULTS: Participants reported sleeping an average of 6.36 (SD ±1.1) hours per night, and the majority worked more than 40 hours per week. Data were analyzed using an inductive approach. The findings provided important insights. In normalizing sleep deprivation and prioritizing the need to "just keep going" on six or less hours of sleep, the men subscribed to masculine ideals related to workplace perseverance, stamina and resilience. Workplace cultures and practices were implicated including normative dimensions of overtime and high productivity and output, amid masculine cultures constraining emotions and conversations about sleep, the sum of which muted avenues for discussing, let alone promoting sleep. Challenges to good sleep were primarily constructed around time constraints, and worry about meeting work and home responsibilities. Men's preferences for workplace support included providing and incentivizing the use of sleep health resources, designing work for sleep health (e.g., shift schedules, overtime policies) and getting advice from experienced coworkers and experts external to the workplace organization. CONCLUSION: These findings hold potential for informing future gender-sensitive programming and organizational practices to support sleep health among working men.

Support for healthcare workers and patients after medical error through mutual healing: another step towards patient safety.

BACKGROUND: Medical errors, especially those resulting in patient harm, have a negative psychological impact on patients and healthcare workers (HCWs). Healing may be promoted if both parties are able to work together and explore the effect and outcome of the event from each of their perspectives. There is little existing research in this area, even though this has the potential to improve patient safety and wellness for both HCWs and patients. METHODS: Using a patient-oriented research approach with constructive grounded theory methodology, we examined the potential for patients and HCWs to heal together after harm from a medical error. Individual interviews were conducted and transcribed verbatim. We conducted concurrent data collection and analysis according to grounded theory principles. With our findings, we created a framework and visual breakdown of the communication process between patients and HCWs. RESULTS: Our findings suggest that, after a medical error causing harm, both patients and HCWs have feelings of empathy and respect towards each other that often goes unrecognised. Barriers to communication for patients were related to their perception that HCWs did not care about them, showed no remorse or did not admit to the error. For HCWs, communication barriers were related to feelings of blame or shame, and fear of professional and legal consequences. Patients reported needing open and transparent communications to help them heal, and HCWs required leadership and peer support, including training and space to talk about the event(s). DISCUSSION: Our resulting framework suggests that if there was an opportunity for an open and purposeful conversation early or before increased emotional suffering, there might be an opportunity to bridge the barriers, and help patients and HCWs heal together. This, in turn, contributes to improved health quality and patient safety.

The use of patient-reported outcome measures in primary care: applications, benefits and challenges.

PROMs use in primary care has expanded from simply describing patient populations to contributing to decision-making, in response to the increasingly complex, ever-changing healthcare environment. In Alberta, primary care is organized into primary care networks (PCNs), where family physicians are grouped geographically and supported by allied health professionals. PCNs implement programs and services in response to local population health needs with frequent evaluation, often incorporating PROMs for this purpose. As PCN programs and services vary greatly across Alberta, so do their use of PROMs. An area of commonality is the use of the EQ-5D-5L instrument; 29 out of 41 PCNs are registered and licensed to use the instrument. It is often administrated by paper, pre- and post-program, and in combination with other specific measures, depending on the program or target population. Some PCNs share programming and therefore outcome measurement, but often the selection, implementation (including training and administration procedures) and evaluation/reporting of PROMs are unique to the PCN. As well, data analysis is largely dependent on the size and capacity of the PCN. Using PROMs for PCN program evaluation supports clinical understanding and complements clinical outcomes. PROMs describe the population attending a program, as well as provide an element of consistency when examining trends across multiple programs or timepoints. This contributes to inquiries and decisions around program development, components, administrative features, resource allocation and delivery. Challenges of PROMs use in primary care include the absence of cohesive data capture technology. This limits data capabilities and presents difficulties with data fidelity, storage, export, and analysis. Additionally, this real-world application lacks a control arm and presents methodological challenges for comparative research purposes. Furthermore, capturing long term patient outcomes poses administrative challenges of multiple follow ups. More research is required into best reporting mechanisms to ensure the data is used to its full potential. To overcome these challenges, leadership and clinician engagement are key. As well, determining consistent PCN PROM reporting requirements will ensure data are comparable across PCNs and contribute to provincial level evaluations, further supporting the movement towards overall health system quality improvement.

Adopting and implementing an innovative model to organize diabetes care within First Nations communities: A qualitative assessment.

BACKGROUND: Diabetes care remains suboptimal in First Nations populations. Innovative and culturally relevant approaches are needed to promote systematic and proactive organization of diabetes care for people living with diabetes on-reserve in Canada. The RADAR model is one strategy to improve care: an integrated disease registry paired with an electronic health record for local community healthcare providers with remote care coordination. We qualitatively assessed adoption and implementation of RADAR in First Nations communities in Alberta to inform its potential spread in the province. METHODS: We used the RE-AIM framework to evaluate adoption and implementation of RADAR in 6 First Nations communities. Using purposeful sampling, we recruited local healthcare providers and remote care coordinators involved in delivering RADAR to participate in telephone or in-person interviews at 6- and 24-months post-implementation. Interviews were digitally recorded, transcribed, and verified for accuracy. Data was analyzed using content analysis and managed using ATLAS.ti 8. RESULTS: In total, we conducted 21 semi-structured interviews (6 at 6-months; 15 at 24-months) with 11 participants. Participants included 3 care coordinators and 8 local healthcare providers, including registered nurses, licensed practical nurses, and registered dietitians. We found that adoption of RADAR was influenced by leadership as well as appropriateness, acceptability, and perceived value of the model. In addition, we found that implementation of RADAR was variable across communities regardless of implementation supports and appropriate community-specific adaptations. CONCLUSIONS: The variable adoption and implementation of RADAR has implications for how likely it will achieve its anticipated outcomes. RADAR is well positioned for spread through continued appropriate community-based adaptations and by expanding the existing implementation supports, including dedicated human resources to support the delivery of RADAR and the provision of levels of RADAR based on existing or developed capacity among local HCPs. TRIAL REGISTRATION: Not applicable to this qualitative assessment.  ISRCTN14359671 .

Men's Physical Activity and Sleep Following a Workplace Health Intervention: Findings from the POWERPLAY STEP Up challenge.

The workplace provides an important delivery point for health promotion, yet many programs fail to engage men. A gender-sensitive 8-week team challenge-based intervention targeting increased physical activity was delivered at a petrochemical worksite. The purpose of this study was to examine men's pre-post physical activity and sleep following the intervention, as well as to explore program acceptability and gather men's recommendations for health promotion. Pre-post surveys assessed physical activity, sleep, program exposure, acceptability, and suggestions for continued support. Overall, 328 men completed baseline surveys and 186 (57%) completed follow-up surveys. Walking increased by 156.5 min/week, 95% confidence interval (61.2, 251.8), p = .001. Men with higher program exposure increased moderate and vigorous activity 49.4 min more than those with low exposure (p = .026). Sleep duration and quality were higher postintervention, though changes were modest. Program acceptability was high as was intention to maintain physical activity. Men's suggestions to enable physical activity involved workplace practices/resources, reducing workload, and leadership support. These findings suggest that a gender-sensitive physical activity workplace intervention showed promise for improving physical activity and sleep among men. The men's suggestions reflected workplace health promotion strategies, reinforcing the need for employers to support ongoing health promotion efforts.

A systematic review of workplace behavioral interventions to promote sleep health in men.

Sleep health is an important aspect of wellbeing and merits incorporation into workplace health promotion programs for employees. Men are a unique population with whom many traditional workplace health promotion programs have had limited success. This systematic review posed the question do workplace health promotion programs improve sleep among men, and what program design features contribute to improving sleep among working men? Databases searched were MEDLINE, EMBASE, the Cochrane Library, CINHAL, Academic Search Complete and Health Source: Nursing/Academic Edition and Google Scholar. Empirical research reporting non-pharmacological behavioral sleep programs and/or interventions for working men were eligible for review. 1049 articles were identified; 15 intervention studies were included: 13 interventions were delivered through workplaces, and two recruited workers to programs delivered outside of work. Interventions incorporated health education, stress reduction/relaxation, and/or physical activity components. Eleven studies reported positive findings for sleep health outcome(s) in men. A moderate level of evidence exists for sleep health programs with physical activity and stress management components. Evidence for the effectiveness of sleep health education programs was mixed. That only one study included a gender-sensitized intervention, where men's preferences shaped the content of a stress-reduction program which resulted in improved sleep quality, attests to the insufficient evidence and lack of gender-specific content and analyses. Next research steps should include considering cultural constructions of masculinity in program design in order to strengthen the appeal and engagement of men, and optimize health benefits for working men.

A Longitudinal Study on the Association Between Diabetic Foot Disease and Health-Related Quality of Life in Adults With Type 2 Diabetes.

OBJECTIVES: The aim of this study was to assess the association between diabetic foot disease and health-related quality of life (HRQOL) during a 2-year follow up among people with type 2 diabetes in Alberta. METHODS: A type 2 diabetes cohort was established (2011‒2013); those with self-reported diabetic foot disease were identified. HRQOL was assessed at baseline and 1 and 2 years. Scores from the 12-item Short Form Physical Component Summary (PCS) and Mental Component Summary (MCS) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument were collected. The association between diabetic foot disease and changes in HRQOL was assessed using the general linear mixed model after adjustment for sociodemographics, previous health-care use, Elixhauser comorbidities index, baseline health status and diabetes-specific behaviours. RESULTS: Among the cohort (n=969), average age was 64.3 (standard deviation, 10.0) years and 55% were male. Overall, 265 (27.4%) participants reported having diabetic foot disease. Those with diabetic foot disease reported lower HRQOL in comparison to those without diabetic foot disease at baseline: PCS, 8.44 (95% confidence interval [CI], 7.06 to 9.82); MCS, 4.33 (95% CI, 2.99 to 5.67) and EQ-5D-5L index score, 0.12 (95% CI, 0.09 to 0.14). After adjustment, no differences were observed in the score changes at year 2 (PCS, 0.16 [95% CI, -0.88 to 1.21]; MCS, 0.36 [95% CI, -0.77 to 1.50]; EQ-5D-5L index score, 0.004 [95% CI, -0.01 to 0.02]). CONCLUSIONS: Although participants with diabetic foot disease reported lower HRQOL at baseline, they had similar changes compared to those without diabetic foot disease during the 2-year follow up. Efforts to maintain general health and early intervention to prevent diabetic foot disease may help to avoid initial deterioration of physical health and HRQOL.

Systematic review of community pharmacy-based and pharmacist-led foot care interventions for adults with type 2 diabetes.

BACKGROUND: To prevent diabetic foot disease, proper foot care is essential for early detection and treatment. Pharmacists are well suited to provide accessible foot care to adults with type 2 diabetes. Limited research has examined this role. METHODS: We conducted a systematic review of community pharmacy-based and pharmacist-led foot care interventions for adults with type 2 diabetes compared to usual care. Data sources included MEDLINE, EMBASE, the Cochrane Library, CINAHL, Academic Search Complete and Health Source: Nursing/Academic Edition and Google Scholar, plus Google and hand-searching. Original research studies reported in English, focused on community pharmacy-based or pharmacist-led foot care interventions were eligible for review. Participants were adults with type 2 diabetes. Studies were summarized narratively; pooled data were not possible. RESULTS: Seven studies were included in this review, 3 focusing on improving foot self-care behaviours and 4 on promoting foot examinations by the health care provider. Only 2 studies were randomized and were assessed as high quality. Six out of 7 studies reported significantly positive findings related to foot care practices. DISCUSSION: An opportunity to influence foot care exists at each clinical encounter. Pharmacists are accessible health care practitioners and appropriate to provide a range of diabetes foot care interventions. CONCLUSIONS: Seven studies examined community pharmacy-based and pharmacist-led foot care interventions for people with type 2 diabetes. Community pharmacies and pharmacists are capable of providing a variety of foot care interventions to patients with diabetes, helping detect problems early and leading to prompt intervention.

The frequency and availability of population-specific patient reported outcome measures and minimal clinically important differences among approved drugs in Canada.

BACKGROUND: Patient reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) are included in Canada's Common Drug Review (CDR) process to approve new drugs. Often, the measures report on the health-related quality of life (HRQoL), but can also describe the symptoms, efficacy and harms important to patients. They can be generic or population/condition specific, validated or not. We examined the frequency, availability and accessibility of validated, specific PROMs and MCIDs reported in the CDR reports. METHODS: We searched the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database for completed Common Drug Review, Clinical Review Reports (CDR-CRR) between November 2013 and February 2017. Two independent reviewers examined the reports and references for PROMs and MCIDs. Both reviewers separately categorized the PROMs and MICDs according to purpose, validation, availability and funding received. Discrepancies were rectified by consensus with a third investigator. RESULTS: One-hundred and five unique PROMs were extracted from 39 CDR-CRR, 57% with a HRQoL component. 91/105 (87%) referenced a validation study and 62/105 (59%) referenced a validation study in the study population of interest. Fifty-seven MCID references were extracted from 39 CDR-CRR. 34/57 (60%) were specific to the study population of interest, and 36% had a HRQoL component. 50% of PROM and 53% of MCID references were publicly available. CONCLUSIONS: PROMs and MCIDs referenced in CDR-CRR show similar trends. The majority are validated, but not necessarily in the study population of interest. Continued critical examination is required to evaluate new drugs specific to the population of interest.

The association of self-efficacy and hospitalization rates in people with type-2 diabetes: A prospective cohort study.

AIMS: Self-efficacy is presumed important in chronic disease management; we assessed the association between self-efficacy and risk of hospitalization in adults with type-2 diabetes. METHODS: A prospective cohort was assembled between December 2011 to December 2013. Participants completed an extensive survey, including a previously validated 6-item assessment of chronic disease management self-efficacy. The association between self-efficacy (low, medium, high) and all-cause hospitalization within 1 year of the survey was assessed using multivariable logistic regression, after adjustment for sociodemographic characteristics, physical, behavioral and psychosocial factors. RESULTS: Among the cohort (n = 1915), the average age was 64.5 (SD 10.7) years, 45.3% were women and 199 (10.4%), 459 (24.0%) and 1257 (65.6%) participants reported low, medium and high self-efficacy, respectively. Participants with low self-efficacy were younger, had more comorbidities, and followed less healthy behaviors compared to those with high self-efficacy. In unadjusted analyses, low self-efficacy was associated with increased risk of hospitalization (23.6% vs 9.6%; odds ratio (OR) 2.90: 95% confidence interval (95%CI 1.99, 4.23)) compared to those with high self-efficacy, while no significant association was observed for medium self-efficacy level (OR 1.28: 95%CI 0.91, 1.79). After adjustment, there was no difference in hospitalization risk for participants with low (OR 0.99; 95%CI 0.59, 1.67) or medium (OR 0.67; 95%CI 0.44, 1.01) self-efficacy compared to high self-efficacy. CONCLUSIONS: Our results suggest that self-efficacy is not independently associated with lower all-cause hospitalization in this population. Focus on additional heath aspects are likely required to improve overall health outcomes in people with type-2 diabetes.

An analysis of redactions in Canada's Common Drug Review Clinical Review Reports and how they relate to the patients' voice.

IMPORTANCE: Canada's Common Drug Review (CDR) evaluates drug data from published and unpublished research, as well as input from patient groups, to recommend provincial coverage. Currently, the CDR process gives manufacturers the opportunity to redact information in the final publicly available report. Patients often have strong feelings regarding the efficacy, harms, health-related quality of life (HRQL), and cost associated with the drugs under review and their redacted data. Highlighting Canada's approach will hopefully build on the growing international concern regarding transparency of clinical study data. OBJECTIVE: The purpose was to objectively examine and classify completed, publicly available CDR-Clinical Review Reports (CRR) for redactions, and compare them to the patients' reported interests as patient-centred outcomes. METHODS: Two independent reviewers searched for and examined publicly available CDR-CRR from November 2013-September 2016 through the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database. Both reviewers separately classified the redactions and patient-reported interests into the following categories: efficacy, harms, HRQL and costs. All discrepancies were rectified by consensus involving a third reviewer. RESULTS: Fifty-two completed CDR-CRR were reviewed. 48 (92%) included patient-reported interests and 40 (77%) had redactions classified in the following categories: efficacy (75%), costs (48%), harms (38%), HRQL (23%). 89% of redactions were outcomes identified as patient-reported interests (69% efficacy, 42% harms, 36% cost, 33% HRQL). When examining drug characteristics, biological agents were statistically associated with increased odds of redactions with respect to either efficacy (OR 3.4, 95% CI 1.0 to 11.6) or harms (OR 3.5, 95% CI 1.02 to 12.4) compared with non-biological agents. CONCLUSIONS: Whether data from the CDR-CRR used in the decision-making should be fully disclosed to the public is controversial. Our findings suggest clinical data (efficacy, harms, HRQL) matters to patients and should be publicly available within the CDR-CRR. Canada trails Europe and the USA regarding the transparency of clinical study data. This lack of transparency relates to the patient voice, and limits movement towards patient-centred care and patient-engaged research, restricting real-world value measurement.

Addressing the gaps in diabetes care in first nations communities with the reorganizing the approach to diabetes through the application of registries (RADAR): the project protocol.

BACKGROUND: Type-2 diabetes rates in First Nations communities are 3-5 times higher than the general Canadian population, resulting in a high burden of disease, complications and comorbidity. Limited community nursing capacity, isolated environments and a lack of electronic health records (EHR)/registries lead to a reactive, disorganized approach to diabetes care for many First Nations people. The Reorganizing the Approach to Diabetes through the Application of Registries (RADAR) project was developed in alignments with federal calls for innovative, culturally relevant, community-specific programs for people with type-2 diabetes developed and delivered in partnership with target communities. METHODS: RADAR applies both an integrated diabetes EHR/registry system (CARE platform) and centralized care coordinator (CC) service that will support local healthcare. The CC will work with local healthcare workers to support patient and community health needs (using the CARE platform) and build capacity in best practices for type-2 diabetes management. A modified stepped wedge controlled trial design will be used to evaluate the model. During the baseline phase, the CC will work with local healthcare workers to identify patients with type-2 diabetes and register them into the CARE platform, but not make any management recommendations. During the intervention phase, the CC will work with local healthcare workers to proactively manage patients with type-2 diabetes, including monitoring and recall of patients, relaying clinical information and coordinating care, facilitated through the shared use of the CARE platform. The RE-AIM framework will provide a comprehensive assessment of the model. The primary outcome measure will be a 10% improvement in any one of A1c, BP, or cholesterol over the baseline values. Secondary endpoints will address other diabetes care indicators including: the proportion of clinical measures completed in accordance with guidelines (e.g., foot and eye examination, receipt of vaccinations, smoking cessation counseling); the number of patients registered in CARE; and the proportion of patients linked to a health services provider. The cost-effectiveness of RADAR specific to these communities will be assessed. Concurrent qualitative assessments will provide contextual information, such as the quality/usability of the CARE platform and the impact/satisfaction with the model. DISCUSSION: RADAR combines innovative technology with personalized support to deliver organized diabetes care in remote First Nations communities in Alberta. By improving the ability of First Nations to systematically identify and track diabetes patients and share information seamlessly an overall improvement in the quality of clinical care of First Nations people living with type-2 diabetes on reserve is anticipated. TRIAL REGISTRATION: ISRCTN study ID ISRCTN14359671 , retrospectively registered October 7, 2016.

A qualitative study examining healthcare managers and providers' perspectives on participating in primary care implementation research.

BACKGROUND: Primary care reforms should be supported by high-quality evidence across the entire life cycle of research. Front-line healthcare providers play an increasing role in implementation research. We recently evaluated two interventions for people with type 2 diabetes (T2D) in partnership with four Primary Care Networks (PCNs) in Alberta, Canada. Here, we report healthcare professionals perspectives on participating in primary care implementation research. METHODS: Guided by the RE-AIM framework, we collected qualitative data before, during, and after both interventions. We conducted 34 in-person or telephone interviews with 17 individual PCN professionals. We used content analysis to identify emerging codes and concepts. RESULTS: Two major themes emerged from the data. First, healthcare managers were eager to conduct implementation research in a primary care setting. Second, regardless of willingness to conduct research, there were challenges to implementing experimental study designs for both interventions. PCN professionals presumed the interventions were better than usual care, expressed role conflict, and reported administrative burdens related to research participation. Perceptions of patient vulnerability and an obligation to intervene exacerbated these issues. CONCLUSIONS: Healthcare professionals with limited practical research experience might not foresee the challenges in implementing experimental study designs in primary care settings to generate high-quality evidence. These issues are intensified when healthcare professionals perceive target patient populations as vulnerable and in need of intervention based on the presenting illness. Possible solutions include further research training, involving healthcare professionals in study design development, and using non-clinical staff to conduct research activities, particularly among acutely unwell patient populations.

Cost-Effectiveness Evaluation of Collaborative Care for Diabetes and Depression in Primary Care.

INTRODUCTION: Information is limited on the cost effectiveness of strategies to improve depressive symptoms in patients with Type 2 diabetes in primary care outside of the U.S. METHODS: Using patient data from a 12-month controlled implementation trial, outcomes and healthcare costs determined through administrative database linkages were compared for a strategy of family physician notification and follow-up ("enhanced care") versus collaborative care. Two measures of effectiveness were used: depression-free days (DFDs) based on Patient Health Questionnaire, and quality-adjusted life years (QALYs) based on EQ-5D. Data were collected November 2010 to January 2013 with analyses completed in May 2015. Incremental cost-effectiveness ratios were also compared against true usual care patients. RESULTS: Among 227 patients, mean age was 58 years, 55% were female, and mean diabetes duration was 12 years. Compared with total 12-month cost per usual care patient (C$5,889), the incremental cost was C$450 for patients in enhanced care and C$1,021 for collaborative care. Both enhanced and collaborative care strategies improved outcomes compared with usual care, with incremental DFDs of 65.9 and 117.6, and incremental QALYs of 0.006 and 0.042, respectively. Compared with enhanced care, collaborative care yielded incremental cost-effectiveness ratios of C$11/DFD and C$15,861/QALY. Compared with usual care, the incremental cost-effectiveness ratios were C$7/DFD or C$76,271/QALY for enhanced care and C$9/DFD or C$24,368/QALY for collaborative care. CONCLUSIONS: In primary care patients with Type 2 diabetes who screened positive for depression, physician notification and follow-up was a clinically effective strategy compared with usual care, but investing more resources in collaborative care yielded the most cost-effective strategy.

Contextualizing the Proven Effectiveness of a Lifestyle Intervention for Type 2 Diabetes in Primary Care: A Qualitative Assessment Based on the RE-AIM Framework.

OBJECTIVE: The Healthy Eating and Active Living for Diabetes in Primary Care Networks (HEALD) intervention proved effective in increasing daily physical activity among people with type 2 diabetes in 4 community-based primary care networks (PCNs) in Alberta. Here, we contextualize its effectiveness by describing implementation fidelity and PCN staff's perceptions of its success in improving diabetes management. METHODS: We used the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate the HEALD intervention. Qualitative methods used to collect data related to the RE-AIM dimensions of implementation and effectiveness included interviews with PCN staff (n=24), research team reflections (n=4) and systematic documentation. We used content analysis, and data were imported into and managed using Nvivo 10. RESULTS: HEALD was implemented as intended with adequate fidelity across all 4 PCNs. Identified implementation facilitators included appropriate human resources, the training provided, ongoing support, the provision of space and the simplicity of the intervention. However, PCN staff reported varying opinions regarding its potential for improving diabetes management among patients. Rationales for their views included intervention "dose" inadequacy; that the quality of usual care for people with diabetes was already good; patients were already managing their diabetes well; and the potential for cointervention. Recommended improvements to HEALD included increasing the dose of the intervention, expanding it to other modes of exercise and incorporating a medical clearance process. CONCLUSIONS: Based on the high degree of fidelity, the demonstrated effectiveness of HEALD in improving physical activity among patients was a result of sound implementation of an efficacious intervention. Increasing the dose of HEALD could result in additional improvements for patients.