Trivalent and quadrivalent seasonal influenza vaccine in adults aged 60 and older: a systematic review and network meta-analysis.

OBJECTIVES: To compare the efficacy of influenza vaccines of any valency for adults 60 years and older. DESIGN AND SETTING: Systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs). MEDLINE, EMBASE, JBI Evidence-Based Practice (EBP) Database, PsycINFO, and Cochrane Evidence -Based Medicine database were searched from inception to 20 June 20, 2022. Two reviewers screened, abstracted, and appraised articles (Cochrane Risk of Bias (ROB) 2.0 tool) independently. We assessed certainty of findings using Confidence in Network Meta-Analysis and Grading of Recommendations, Assessment, Development and Evaluations approaches. We performed random-effects meta-analysis and network meta-analysis (NMA), and estimated odds ratios (ORs) for dichotomous outcomes and incidence rate ratios (IRRs) for count outcomes along with their corresponding 95% confidence intervals (CIs) and prediction intervals. PARTICIPANTS: Older adults (≥60 years old) receiving an influenza vaccine licensed in Canada or the USA (vs placebo, no vaccine, or any other licensed vaccine), at any dose. MAIN OUTCOME MEASURES: Laboratory-confirmed influenza (LCI) and influenza-like illness (ILI). Secondary outcomes were the number of vascular adverse events, hospitalisation for acute respiratory infection (ARI) and ILI, inpatient hospitalisation, emergency room (ER) visit for ILI, outpatient visit, and mortality, among others. RESULTS: We included 41 RCTs and 15 companion reports comprising 8 vaccine types and 206 032 participants. Vaccines may prevent LCI compared with placebo, with high-dose trivalent inactivated influenza vaccine (IIV3-HD) (NMA: 9 RCTs, 52 202 participants, OR 0.23, 95% confidence interval (CI) (0.11 to 0.51), low certainty of evidence) and recombinant influenza vaccine (RIV) (OR 0.25, 95%CI (0.08 to 0.73), low certainty of evidence) among the most efficacious vaccines. Standard dose trivalent IIV3 (IIV3-SD) may prevent ILI compared with placebo, but the result was imprecise (meta-analysis: 2 RCTs, 854 participants, OR 0.39, 95%CI (0.15 to 1.02), low certainty of evidence). Any HD was associated with prevention of ILI compared with placebo (NMA: 9 RCTs, 65 658 participants, OR 0.38, 95%CI (0.15 to 0.93)). Adjuvanted quadrivalent IIV (IIV4-Adj) may be associated with the least vascular adverse events, but the results were very uncertain (NMA: eight 8 RCTs, 57 677 participants, IRR 0.18, 95%CI (0.07 to 0.43), very low certainty of evidence). RIV on all-cause mortality may be comparable to placebo (NMA: 20 RCTs, 140 577 participants, OR 1.01, 95%CI (0.23 to 4.49), low certainty of evidence). CONCLUSIONS: This systematic review demonstrated efficacy associated with IIV3-HD and RIV vaccines in protecting older persons against LCI. RIV vaccine may reduce all-cause mortality when compared with other vaccines, but the evidence is uncertain. Differences in efficacy between influenza vaccines remain uncertain with very low to moderate certainty of evidence. PROSPERO REGISTRATION NUMBER: CRD42020177357.

Safety of influenza vaccination during pregnancy: a systematic review.

OBJECTIVE: We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases. METHODS: Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty. RESULTS: Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty. CONCLUSIONS: Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.

Efficacy of sustained knowledge translation (KT) interventions in chronic disease management in older adults: systematic review and meta-analysis of complex interventions.

BACKGROUND: Chronic disease management (CDM) through sustained knowledge translation (KT) interventions ensures long-term, high-quality care. We assessed implementation of KT interventions for supporting CDM and their efficacy when sustained in older adults. METHODS: Design: Systematic review with meta-analysis engaging 17 knowledge users using integrated KT. ELIGIBILITY CRITERIA: Randomized controlled trials (RCTs) including adults (> 65 years old) with chronic disease(s), their caregivers, health and/or policy-decision makers receiving a KT intervention to carry out a CDM intervention for at least 12 months (versus other KT interventions or usual care). INFORMATION SOURCES: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from each database's inception to March 2020. OUTCOME MEASURES: Sustainability, fidelity, adherence of KT interventions for CDM practice, quality of life (QOL) and quality of care (QOC). Data extraction, risk of bias (ROB) assessment: We screened, abstracted and appraised articles (Effective Practice and Organisation of Care ROB tool) independently and in duplicate. DATA SYNTHESIS: We performed both random-effects and fixed-effect meta-analyses and estimated mean differences (MDs) for continuous and odds ratios (ORs) for dichotomous data. RESULTS: We included 158 RCTs (973,074 participants [961,745 patients, 5540 caregivers, 5789 providers]) and 39 companion reports comprising 329 KT interventions, involving patients (43.2%), healthcare providers (20.7%) or both (10.9%). We identified 16 studies described as assessing sustainability in 8.1% interventions, 67 studies as assessing adherence in 35.6% interventions and 20 studies as assessing fidelity in 8.7% of the interventions. Most meta-analyses suggested that KT interventions improved QOL, but imprecisely (36 item Short-Form mental [SF-36 mental]: MD 1.11, 95% confidence interval [CI] [- 1.25, 3.47], 14 RCTs, 5876 participants, I2 = 96%; European QOL-5 dimensions: MD 0.01, 95% CI [- 0.01, 0.02], 15 RCTs, 6628 participants, I2 = 25%; St George's Respiratory Questionnaire: MD - 2.12, 95% CI [- 3.72, - 0.51] 44 12 RCTs, 2893 participants, I2 = 44%). KT interventions improved QOC (OR 1.55, 95% CI [1.29, 1.85], 12 RCTS, 5271 participants, I2 = 21%). CONCLUSIONS: KT intervention sustainability was infrequently defined and assessed. Sustained KT interventions have the potential to improve QOL and QOC in older adults with CDM. However, their overall efficacy remains uncertain and it varies by effect modifiers, including intervention type, chronic disease number, comorbidities, and participant age. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018084810.

Rapid antigen-based and rapid molecular tests for the detection of SARS-CoV-2: a rapid review with network meta-analysis of diagnostic test accuracy studies.

BACKGROUND: The global spread of COVID-19 created an explosion in rapid tests with results in < 1 hour, but their relative performance characteristics are not fully understood yet. Our aim was to determine the most sensitive and specific rapid test for the diagnosis of SARS-CoV-2. METHODS: Design: Rapid review and diagnostic test accuracy network meta-analysis (DTA-NMA). ELIGIBILITY CRITERIA: Randomized controlled trials (RCTs) and observational studies assessing rapid antigen and/or rapid molecular test(s) to detect SARS-CoV-2 in participants of any age, suspected or not with SARS-CoV-2 infection. INFORMATION SOURCES: Embase, MEDLINE, and Cochrane Central Register of Controlled Trials, up to September 12, 2021. OUTCOME MEASURES: Sensitivity and specificity of rapid antigen and molecular tests suitable for detecting SARS-CoV-2. Data extraction and risk of bias assessment: Screening of literature search results was conducted by one reviewer; data abstraction was completed by one reviewer and independently verified by a second reviewer. Risk of bias was not assessed in the included studies. DATA SYNTHESIS: Random-effects meta-analysis and DTA-NMA. RESULTS: We included 93 studies (reported in 88 articles) relating to 36 rapid antigen tests in 104,961 participants and 23 rapid molecular tests in 10,449 participants. Overall, rapid antigen tests had a sensitivity of 0.75 (95% confidence interval 0.70-0.79) and specificity of 0.99 (0.98-0.99). Rapid antigen test sensitivity was higher when nasal or combined samples (e.g., combinations of nose, throat, mouth, or saliva samples) were used, but lower when nasopharyngeal samples were used, and in those classified as asymptomatic at the time of testing. Rapid molecular tests may result in fewer false negatives than rapid antigen tests (sensitivity: 0.93, 0.88-0.96; specificity: 0.98, 0.97-0.99). The tests with the highest sensitivity and specificity estimates were the Xpert Xpress rapid molecular test by Cepheid (sensitivity: 0.99, 0.83-1.00; specificity: 0.97, 0.69-1.00) among the 23 commercial rapid molecular tests and the COVID-VIRO test by AAZ-LMB (sensitivity: 0.93, 0.48-0.99; specificity: 0.98, 0.44-1.00) among the 36 rapid antigen tests we examined. CONCLUSIONS: Rapid molecular tests were associated with both high sensitivity and specificity, while rapid antigen tests were mainly associated with high specificity, according to the minimum performance requirements by WHO and Health Canada. Our rapid review was limited to English, peer-reviewed published results of commercial tests, and study risk of bias was not assessed. A full systematic review is required. REVIEW REGISTRATION: PROSPERO CRD42021289712.

Understanding Engagement and the Potential Impact of an Electronic Drug Repository: Multi-Methods Study.

BACKGROUND: Centralized drug repositories can reduce adverse events and inappropriate prescriptions by enabling access to dispensed medication data at the point of care; however, how they achieve this goal is largely unknown. OBJECTIVE: This study aims to understand the perceived clinical value; the barriers to and enablers of adoption; and the clinician groups for which a provincial, centralized drug repository may provide the most benefit. METHODS: A mixed methods approach, including a web-based survey and semistructured interviews, was used. Participants were clinicians (eg, nurses, physicians, and pharmacists) in Ontario who were eligible to use the digital health drug repository (DHDR), irrespective of actual use. Survey data were ranked on a 7-point adjectival scale and analyzed using descriptive statistics, and interviews were analyzed using qualitative descriptions. RESULTS: Of the 161 survey respondents, only 40 (24.8%) actively used the DHDR. Perceptions of the utility of the DHDR were neutral (mean scores ranged from 4.11 to 4.76). Of the 75.2% (121/161) who did not use the DHDR, 97.5% (118/121) rated access to medication information (eg, dose, strength, and frequency) as important. Reasons for not using the DHDR included the cumbersome access process and the perception that available data were incomplete or inaccurate. Of the 33 interviews completed, 26 (79%) were active DHDR users. The DHDR was a satisfactory source of secondary information; however, the absence of medication instructions and prescribed medications (which were not dispensed) limited its ability to provide a comprehensive profile to meaningfully support clinical decision-making. CONCLUSIONS: Digital drug repositories must be adjusted to align with the clinician's needs to provide value. Ensuring integration with point-of-care systems, comprehensive clinical data, and streamlined onboarding processes would optimize clinically meaningful use. The electronic provision of accessible drug information to providers across health care settings has the potential to improve efficiency and reduce medication errors.

Software to Conduct a Meta-Analysis and Network Meta-Analysis.

Statistical software for meta-analysis (MA) and network meta-analysis (NMA) have become indispensable for researchers. The aim of this chapter is to introduce key features of MA and NMA software to compare the effectiveness of interventions. Commonly used or routinely maintained statistical software are reviewed, including commercial and open-sourced programs such as Stata, R and Excel plug-ins. It does not provide a comprehensive overview of all features available in the software covered. Rather, it focuses on the essential features required to carry out an MA or NMA . This chapter begins with a review of key considerations when implementing an MA or NMA , then presents a summary of the software. Key features of each software option are discussed.

Establishing best practices in cancer online support groups: protocol for a realist review.

INTRODUCTION: Considerable observational evidence suggests that cancer online support groups reduce feelings of isolation, depression and anxiety, enhance coping and self-management, and lead to better informed patients. Other studies indicate that cancer online support groups can increase distress. Yet no studies theorise the complex, context-dependent mechanisms by which cancer online support groups generate their-sometimes contrasting-outcomes. METHODS AND ANALYSIS: Guided by an integrated knowledge translation approach and the strategy for patient-oriented research, we will conduct a realist review of cancer online support groups in partnership with stakeholders. We will follow Pawson's five steps and existing quality standards to develop a program theory that explains how cancer online support groups work, for whom and in what circumstances. The specific research questions will be: what positive and negative outcomes have been reported on cancer online support groups? What are the mechanisms that are associated with these outcomes, in which contexts and for whom? Through a rigorous review of relevant scientific and grey literature, as well as ongoing dialogue with stakeholders, a program theory will be developed to explain who benefits from cancer online support groups and who does not, what benefits they derive (or do not), and the factors that affect these outcomes. ETHICS AND DISSEMINATION: The use of secondary data for this review precludes the need for ethical approval. Dissemination will be informed by the knowledge-to-action framework and will consist of tailored knowledge products that are conceived of collaboratively with stakeholders. These will include peer-reviewed publications on how cancer online support groups can be optimised and best practice recommendations to maximise the benefits experienced by people with cancer. These traditional scientific outputs, along with their respective evidence summaries, will be amplified through strategic social media events hosted and promoted by knowledge users. PROSPERO REGISTRATION NUMBER: CRD42021250046.

Facilitators of and barriers to buprenorphine initiation for people with opioid use disorder in the emergency department: protocol for a scoping review.

INTRODUCTION: Buprenorphine-naloxone is recommended as a first-line agent for the treatment of opioid use disorder. Although initiation of buprenorphine in the emergency department (ED) is evidence based, barriers to implementation persist. A comprehensive review and critical analysis of both facilitators of and barriers to buprenorphine initiation in ED has yet to be published. Our objectives are (1) to map the implementation of buprenorphine induction pathway literature and synthesise what we know about buprenorphine pathways in EDs and (2) to identify gaps in this literature with respect to barriers and facilitators of implementation. METHODS AND ANALYSIS: We will conduct a scoping review to comprehensively search the literature, map the evidence and identify gaps in knowledge. The review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols Extension for Scoping Reviews and guidance from the Joanna Briggs Institution for conduct of scoping reviews. We will search Medline, APA, PsycINFO, CINAHL, Embase and IBSS from 1995 to present and the search will be restricted to English and French language publications. Citations will be screened in Covidence by two trained reviewers. Discrepancies will be mediated by consensus. Data will be synthesised using a hybrid, inductive-deductive approach, informed by the Consolidated Framework for Implementation Research as well as critical theory to guide further interpretation. ETHICS AND DISSEMINATION: This review does not require ethics approval. A group of primary knowledge users, including clinicians and people with lived experience, will be involved in the dissemination of findings including publication in peer-reviewed journals. Results will inform future research, current quality improvement efforts in affiliated hospitals, and aide the creation of a more robust ED response to the escalating overdose crisis.

Developing an explanatory theoretical model for engagement with a web-based mental health platform: results of a mixed methods study.

BACKGROUND: With the growing need for accessible, high-quality mental health services, especially during the COVID-19 pandemic, there has been increasing development and uptake of web-based interventions in the form of self-directed mental health platforms. The Big White Wall (BWW) is a web-based platform for people experiencing mental illness and addiction that offers a range of evidence-based self-directed treatment strategies. Drawing on existing data from a large-scale evaluation of the implementation of BWW in Ontario, Canada (which involved a pragmatic randomized controlled trail with an embedded qualitative process evaluation), we sought to investigate the influences on the extent to which people engage with BWW. METHODS: In this paper we drew on BWW trial participants' usage data (number of logins) and the qualitative data from the process evaluation that explored participants' experiences, engagement with and reactions to BWW. RESULTS: Our results showed that there were highly complex relationships between the influences that contributed to the level of engagement with BWW intervention. We found that a) how people expected to benefit from using a platform like BWW was an important indicator of their future usage, b) moderate perceived symptoms were linked with higher engagement; whereas fewer actual depressive symptoms predicted use and anxiety had a positive linear relationship with usage, and that c) usage depended on positive early experiences with the platform. CONCLUSIONS: Our findings suggest that the nature of engagement with platforms such as BWW is not easily predicted. We propose a theoretical framework for explaining the level of user engagement with BWW that might also be generalizable to other similar platforms.

Quality of Reporting on Guideline, Protocol, or Algorithm Implementation in Adult Trauma Centers: A Systematic Review.

OBJECTIVE: To appraise the quality of reporting on guideline, protocol, and algorithm implementations in adult trauma settings according to the Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0). BACKGROUND: At present we do not know if published reports of guideline implementations in trauma settings are of sufficient quality to facilitate replication by other centers wishing to implement the same or similar guidelines. METHODS: A systematic review of the literature was conducted. Articles were identified through electronic databases and hand searching relevant trauma journals. Studies meeting inclusion criteria focused on a guideline, protocol, or algorithm that targeted adult trauma patients ≥18 years and/or trauma patient care providers, and evaluated the effectiveness of guideline, protocol, or algorithm implementation in terms of change in clinical practice or patient outcomes. Each included study was assessed in duplicate for adherence to the 18-item SQUIRE 2.0 criteria. The primary endpoint was the proportion of studies meeting at least 80% (score ≥15) of SQUIRE 2.0. RESULTS: Of 7368 screened studies, 74 met inclusion criteria. Thirty-nine percent of studies scored ≥80% on SQUIRE 2.0. Criteria that were met most frequently were abstract (93%), problem description (93%), and specific aims (89%). The lowest scores appeared in the funding (28%), context (47%), and results (54%) criteria. No study indicated using SQUIRE 2.0 as a guideline to writing the report. CONCLUSIONS: Significant opportunity exists to improve the utility of guideline implementation reports in adult trauma settings, particularly in the domains of study context and the implications of context for study outcomes.

Using a behavioural framework to optimize antibiotic prescribing by family medicine residents.

This article was migrated. The article was marked as recommended. Background and objectives:Overprescribing of antibiotics in primary care is a prominent concern in the context of increasing antimicrobial resistance worldwide. Medical trainees are a key group to deliver thoughtful antimicrobial stewardship training. This study examined the factors influencing antibiotic prescribing for upper respiratory tract infections (URTI) by family medicine residents in order to identify educational interventions. Methods: Using purposive sampling of family medicine residents, semi-structured interviews were conducted until thematic saturation was reached. Interviews were coded into the domains of the Theoretical Domains Framework (TDF). Belief statements were created to characterize each domain and categorized as enablers or barriers to appropriate prescribing. Domains were plotted on the Behaviour Change Wheel (BCW) and intervention functions identified. Results:Twelve participants were interviewed. Nine domains of the TDF were relevant to antibiotic prescribing. Social influence was a prominent theme with the preceptor and patient being key influences on resident prescribing. Learning goals were also a key theme including the desire to strengthen independent clinical decision-making skills and improve antibiotic knowledge. Residents' beliefs about capabilities were challenged when faced with diagnostic uncertainty. Additional domains included: professional role; environmental context and resources; intentions; beliefs about consequences and capabilities, and knowledge. Using the BCW, nine intervention functions were identified to change antibiotic prescribing behaviour. Conclusion: This study found nine domains of the TDF were relevant to family medicine resident antibiotic prescribing for URTI. Nine intervention functions could be used to guide intervention design.

Identifying optimal frameworks to implement or evaluate digital health interventions: a scoping review protocol.

INTRODUCTION: Digital health interventions (DHIs) are defined as health services delivered electronically through formal or informal care. DHIs can range from electronic medical records used by providers to mobile health apps used by consumers. DHIs involve complex interactions between user, technology and the healthcare team, posing challenges for implementation and evaluation. Theoretical or interpretive frameworks are crucial in providing researchers guidance and clarity on implementation or evaluation approaches; however, there is a lack of standardisation on which frameworks to use in which contexts. Our goal is to conduct a scoping review to identify frameworks to guide the implementation or evaluation of DHIs. METHODS AND ANALYSIS: A scoping review will be conducted using methods outlined by the Joanna Briggs Institute reviewers' manual and will conform to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Studies will be included if they report on frameworks (ie, theoretical, interpretive, developmental) that are used to guide either implementation or evaluation of DHIs. Electronic databases, including MEDLINE, EMBASE, CINAHL and PsychINFO will be searched in addition to grey literature and reference lists of included studies. Citations and full text articles will be screened independently in Covidence after a reliability check among reviewers. We will use qualitative description to summarise findings and focus on how research objectives and type of DHIs are aligned with the frameworks used. ETHICS AND DISSEMINATION: We engaged an advisory panel of digital health knowledge users to provide input at strategic stages of the scoping review to enhance the relevance of findings and inform dissemination activities. Specifically, they will provide feedback on the eligibility criteria, data abstraction elements, interpretation of findings and assist in developing key messages for dissemination. This study does not require ethical review. Findings from review will support decision making when selecting appropriate frameworks to guide the implementation or evaluation of DHIs.

Methods, Applications and Challenges in the Analysis of Interrupted Time Series Data: A Scoping Review.

OBJECTIVE: Interrupted time series (ITS) designs are robust quasi-experimental designs commonly used to evaluate the impact of interventions and programs implemented in healthcare settings. This scoping review aims to 1) identify and summarize existing methods used in the analysis of ITS studies conducted in health research, 2) elucidate their strengths and limitations, 3) describe their applications in health research and 4) identify any methodological gaps and challenges. DESIGN: Scoping review. DATA SOURCES: Searches were conducted in MEDLINE, JSTOR, PUBMED, EMBASE, CINAHL, Web of Science and the Cochrane Library from inception until September 2017. STUDY SELECTION: Studies in health research involving ITS methods or reporting on the application of ITS designs. DATA EXTRACTION: Screening of studies was completed independently and in duplicate by two reviewers. One reviewer extracted the data from relevant studies in consultations with a second reviewer. Results of the review were presented with respect to methodological and application areas, and data were summarized using descriptive statistics. RESULTS: A total of 1389 articles were included, of which 98.27% (N=1365) were application papers. Segmented linear regression was the most commonly used method (26%, N=360). A small percentage (1.73%, N=24) were methods papers, of which 11 described either the development of novel methods or improvement of existing methods, 7 adapted methods from other areas of statistics, while 6 provided comparative assessment of conventional ITS methods. CONCLUSION: A significantly increasing trend in ITS use over time is observed, where its application in health research almost tripled within the last decade. Several statistical methods are available for analyzing ITS data. Researchers should consider the types of data and validate the required assumptions for the various methods. There is a significant methodological gap in ITS analysis involving aggregated data, where analyses involving such data did not account for heterogeneity across patients and hospital settings.

Identifying and Overcoming Policy-Level Barriers to the Implementation of Digital Health Innovation: Qualitative Study.

BACKGROUND: High-level policy barriers impede widespread adoption for even the most well-positioned innovations. Most of the work in this field assumes rather than analyzes the driving forces of health innovation. Objective: The aim of this study was to explore the challenges and opportunities experienced by health system stakeholders in the implementation of digital health innovation in Ontario. OBJECTIVE: The aim of this study was to explore the challenges and opportunities experienced by health system stakeholders in the implementation of digital health innovation in Ontario. METHODS: We completed semistructured interviews with 10 members of senior leadership across key organizations that are engaged in health care-related digital health activities. Data were analyzed using qualitative description. RESULTS: A total of 6 key policy priorities emerged, including the need for (1) a system-level definition of innovation, (2) a clear overarching mission, and (3) clearly defined organizational roles. Operationally, there is a need to (4) standardize processes, (5) shift the emphasis to change management, and (6) align funding structures. CONCLUSIONS: These findings emphasize the critical role of the government in developing a vision and creating the foundation upon which innovation activities will be modeled.

Engaging knowledge users in a systematic review on the comparative effectiveness of geriatrician-led models of care is possible: A cross-sectional survey using the Patient Engagement Evaluation Tool.

BACKGROUND: A systematic review (SR) was conducted to evaluate the comparative effectiveness of geriatrician-led models of care, and an integrated knowledge translation (iKT) approach facilitated SR relevance. Activities to engage knowledge users (KUs) in the SR were evaluated for perceived level of engagement. STUDY DESIGN AND SETTING: KUs included patients, caregivers, geriatricians, and policymakers from three Canadian provinces. Activities included 1) modified Delphi to select outcomes; 2) cross-sectional survey to select outcome measures, and 3) in-person meeting to discuss SR findings. KU engagement was assessed using the Patient Engagement Evaluation Tool (PEET) after the second and third activities. KUs rated the extent of successful engagement using a 7-point Likert scale ranging from "no extent" to "very large extent." RESULTS: In total, 15 KUs completed the PEET: eight geriatricians, four policymakers, two patients, and one caregiver. Median engagement scores across all activities (median range: 6.00-6.50) indicated that KUs felt engaged. Differences were observed for activity type; perceived engagement at in-person meeting resulted in higher meta-criteria scores for trust (P = 0.005), legitimacy (P = 0.003), fairness (P = 0.013), and competency (P = 0.035) compared with online activities. CONCLUSIONS: KUs can be engaged meaningfully in SR processes. Their perceived engagement was higher for in-person than for online activities.

Variability in the validity and reliability of outcome measures identified in a systematic review to assess treatment efficacy of cognitive enhancers for Alzheimer's Dementia.

INTRODUCTION: Selection of optimal outcome measures is a critical step in a systematic review; inclusion of uncommon or non-validated outcome measures can impact the uptake of systematic review findings. Our goals were to identify the validity and reliability of outcome measures used in primary studies to assess cognition, function, behaviour and global status; and, to use these data to select outcomes for a systematic review (SR) on treatment efficacy of cognitive enhancers for Alzheimer's Dementia (AD). METHODS: Articles fulfilling the eligibility criteria of the SR were included in a charting exercise to catalogue outcome measures reported. Outcome measures were then assessed for validity and reliability. Two independent reviewers abstracted data on outcome measures and validity and reliability reported for cognition, function, behaviour and global status. RESULTS: 129 studies were included in the charting exercise; 57 outcome measures were identified for cognition, 21 for function, 13 for behaviour and 10 for global status. A total of 35 (61%) cognition measures, 10 (48%) functional measures, 8 (61%) behavioural measures and four (40%) of global status measures were only used once in the literature. Validity and reliability information was found for 51% of cognition measures, 90% of function and global status measures and 100% of behavioural measures. CONCLUSIONS: While a large number of outcome measures were used in primary studies, many of these were used only once. Reporting of validity and reliability varied in AD studies of cognitive enhancers. Core outcome sets should be used when available; when they are not available researchers need to balance frequency of reported outcome measures, their respective validity and reliability, and preferences of knowledge users. SYSTEMATIC REVIEW REGISTRATION: CRD#42012001948.

A modified Delphi and cross-sectional survey to facilitate selection of optimal outcomes and measures for a systematic review on geriatrician-led care models.

OBJECTIVE: The objective of this study was to identify relevant outcomes and measures to inform a systematic review (SR) on the comparative effectiveness of geriatrician-led care models. STUDY DESIGN AND SETTING: In the modified Delphi to select outcomes for inclusion in the SR, knowledge users (KUs) from Ontario, Alberta, and Saskatchewan rated outcome importance using a Likert scale. A survey was then completed by geriatricians to determine optimal measures for selected outcomes. Findings were analyzed using frequencies, means, and standard deviations (SDs). RESULTS: Thirty-three KUs (patients, caregivers, policymakers and geriatricians) rated 27 outcomes in round 1 of the modified Delphi. Top-rated outcomes included function (mean 6.85 ± SD 0.36), cognition (6.47 ± SD 0.72), and quality of life (6.38 ± SD 0.91). Twenty-three KUs participated in round 2 and rated 24 outcomes. Top-rated outcomes in round 2 were function (6.87 ± SD 0.34), quality of life (6.45 ± SD 1.10), and cognition (6.43 ± SD 0.73). The survey was completed by 22 geriatricians and the highest ranked measures were Activities of Daily Living (function), Mini-Mental State Examination (cognition), and the Medical Outcomes Study SF-36 (quality of life). CONCLUSION: We identified the most relevant outcomes and measures for patients, caregivers, policymakers, and geriatricians, allowing us to tailor the SR to KU needs.

Uncovering Cultural Barriers to Quality Improvement Learning in a Trauma Program: An Ethnographic Study.

OBJECTIVE: Quality improvement (QI) training is an essential component of postgraduate surgical education and can occur through formal and informal education programs. Informal QI education requires that faculty take advantage of learning opportunities in the hospital setting. Trauma rotations appear ideal opportunities for informal QI learning given that performance improvement is a mandatory component of care at verified trauma centers. It is unclear, however, whether QI initiatives within trauma programs are well integrated into trainee education. This study explored the QI learning environment in a level 1 academic trauma center. STUDY DESIGN: An ethnographic study using observation and interviews methods. The theoretical lens of hidden curriculum was used to interpret the data and generate hypotheses around faculty and trainee experiences. SETTING: University of Toronto and Sunnybrook Health Sciences Center. PARTICIPANTS: Twenty-seven observations involving more than 50 faculty and trainees; seventeen interviews with faculty and surgical trainees. RESULTS: All faculty and trainees endorsed QI and informal QI learning. Discrepant experiences were found regarding opportunities to learn and do QI in the clinical setting. Faculty viewed themselves as perpetually doing and teaching QI while trainees perceived little to no QI learning. Trainees identified Morbidity and Mortality rounds as the main opportunity for QI learning; however, traditional teaching style through "pimping" and a largely clinical focus acted as barriers to QI education. Furthermore, trainees chiefly viewed QI as service to the institution, rather than as a form of learning, which contributed to their disinterest in taking up informal QI lessons. CONCLUSION: Informal QI education is highly valued and desired in academic trauma centers but enduring teaching methods, inconsistencies in the cultural learning environment and a hidden curriculum devaluing QI learning are persistent barriers to change.

A Mobile App to Improve Self-Management of Individuals With Type 2 Diabetes: Qualitative Realist Evaluation.

BACKGROUND: The increasing use of Web-based solutions for health prevention and promotion presents opportunities to improve self-management and adherence to guideline-based therapy for individuals with type 2 diabetes (T2DM). Despite promising preliminary evidence, many users stop using Web-based solutions due to the burden of data entry, hidden costs, loss of interest, and a lack of comprehensive features. Evaluations tend to focus on effectiveness or impact and fail to evaluate the nuanced variables that may interact to contribute to outcome success (or failure). OBJECTIVE: This study aimed to evaluate a Web-based solution for improving self-management in T2DM to identify key combinations of contextual variables and mechanisms of action that explain for whom the solution worked best and in what circumstances. METHODS: A qualitative realist evaluation was conducted with one-on-one, semistructured telephonic interviews completed at baseline, and again toward the end of the intervention period (3 months). Topics included participants' experiences of using the Web-based solution, barriers and facilitators of self-management, and barriers and facilitators to effective use. Transcripts were analyzed using thematic analysis strategies, after which the key themes were used to develop statements of the relationships between the key contextual factors, mechanisms of action, and impact on the primary outcome (glycated hemoglobin, HbA1c). RESULTS: Twenty-six interviews (14 baseline, 12 follow-up) were completed with 16 participants with T2DM, and the following 3 key groups emerged: the easiest fit, the best fit, and those who failed to activate. Self-efficacy and willingness to engage with the solution facilitated improvement in HbA1c, whereas competing priorities and psychosocial issues created barriers to engagement. Individuals with high baseline self-efficacy who were motivated, took ownership for their actions, and prioritized diabetes management were early and eager adopters of the app and recorded improvements in HbA1c over the intervention period. Individuals with moderate baseline self-efficacy and no competing priorities, who identified gaps in understanding of how their actions influence their health, were slow to adopt use but recorded the greatest improvements in HbA1c. The final group had low baseline self-efficacy and identified a range of psychosocial issues and competing priorities. These participants were uncertain of the benefits of using a Web-based solution to support self-management, ultimately resulting in minimal engagement and no improvement in HbA1c. CONCLUSIONS: Self-efficacy, competing priorities, previous behavior change, and beliefs about Web-based solutions interact to determine engagement and impact on the clinical outcomes. Considering the balance of these patient characteristics is likely to help health care providers identify individuals who are apt to benefit from a Web-based solution to support self-management of T2DM. Web-based solutions could be modified to incorporate the existing screening measures to identify individuals who are at risk of suboptimal adherence to inform the provision of additional support(s) as needed.

Comparative Effectiveness and Safety of Cognitive Enhancers for Treating Alzheimer's Disease: Systematic Review and Network Metaanalysis.

BACKGROUND/OBJECTIVES: To examine the comparative effectiveness and safety of cognitive enhancers for Alzheimer's disease (AD). DESIGN: Systematic review and Bayesian network metaanalysis (NMA). SETTING: MEDLINE, EMBASE, Cochrane Library, CINAHL, Ageline (inception-March 2016). PARTICIPANTS: Individuals with AD in randomized controlled trials (RCTs), quasi-RCTs, and nonrandomized studies. INTERVENTION: Any combination of donepezil, rivastigmine, galantamine, or memantine. MEASUREMENTS: Two reviewers independently screened titles, abstracts, and full-texts; abstracted data; and appraised risk of bias. RESULTS: Twenty thousand three hundred forty-three citations were screened, and 142 studies were included (110 RCTs, 21 non-RCTs, 11 cohort studies). NMA found that donepezil (Mini-Mental State Examination: mean difference (MD) = 1.39, 95% credible interval (CrI) = 0.53-2.24), donepezil+memantine (2.59, 95% CrI = 0.12-4.98), and transdermal rivastigmine (2.02, 95% CrI = 0.02-4.08) improved cognition more than placebo. NMA found that donepezil (Alzheimer's Disease Assessment Scale-cognitive: MD = -3.29, 95% CrI = -4.57 to -1.99) and galantamine (MD = -2.13, 95% CrI = -3.91 to -0.27) improved cognition more than placebo. NMA found that donepezil+memantine (MD = -5.23, 95% CrI = -8.72 to -1.56) improved behavior more than placebo. NMA found that donepezil (MD = -0.32, 95% CrI = -0.46 to -0.19), donepezil+memantine (MD = -0.57, 95% CrI = -0.95 to -0.21), oral rivastigmine (MD = -0.38, 95% CrI = -0.56 to -0.17), and galantamine (MD = -3.79, 95% CrI = -6.98 to -0.59) improved global status more than placebo. NMA found that galantamine decreased the odds of mortality (odds ratio = 0.56, 95% CrI = 0.36-0.87). No agent increased risk of serious adverse events, falls, or bradycardia. Some increased risk of headache (oral rivastigmine), diarrhea (oral rivastigmine, donepezil), nausea (oral rivastigmine, donepezil, galantamine), and vomiting (oral rivastigmine, donepezil, galantamine). CONCLUSION: An exhaustive review of the literature involving 142 studies demonstrated that cognitive enhancers in general have minimal effects on cognition according to minimal clinically important difference and global ratings. The drugs appear safe, but this must be interpreted cautiously because trial participants may have less comorbidity and fewer adverse effects than those treated with these drugs in clinical practice.