Evidence Synthesis for Complex Interventions Using Meta-Regression Models.

A goal of evidence synthesis for trials of complex interventions is to inform the design or implementation of novel versions of complex interventions by predicting expected outcomes with each intervention version. Conventional aggregate data meta-analyses of studies comparing complex interventions have limited ability to provide such information. We argue that evidence synthesis for trials of complex interventions should forgo aspirations of estimating causal effects and instead model the response surface of study results to 1) summarize the available evidence and 2) predict the average outcomes of future studies or in new settings. We illustrate this modeling approach using data from a systematic review of diabetes quality improvement (QI) interventions involving at least 1 of 12 QI strategy components. We specify a series of meta-regression models to assess the association of specific components with the posttreatment outcome mean and compare the results to conventional meta-analysis approaches. Compared with conventional approaches, modeling the response surface of study results can better reflect the associations between intervention components and study characteristics with the posttreatment outcome mean. Modeling study results using a response surface approach offers a useful and feasible goal for evidence synthesis of complex interventions that rely on aggregate data.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Economic Evaluations of Chimeric Antigen Receptor T-Cell Therapies for Hematologic and Solid Malignancies: A Systematic Review.

OBJECTIVES: This study aimed to systematically review evidence on the cost-effectiveness of chimeric antigen receptor T-cell (CAR-T) therapies for patients with cancer. METHODS: Electronic databases were searched in October 2022 and updated in September 2023. Systematic reviews, health technology assessments, and economic evaluations that compared costs and effects of CAR-T therapy in patients with cancer were included. Two reviewers independently screened studies, extracted data, synthesized results, and critically appraised studies using the Philips checklist. Cost data were presented in 2022 US dollars. RESULTS: Our search yielded 1809 records, 47 of which were included. Most of included studies were cost-utility analysis, published between 2018 and 2023, and conducted in the United States. Tisagenlecleucel, axicabtagene ciloleucel, idecabtagene vicleucel, ciltacabtagene autoleucel, lisocabtagene maraleucel, brexucabtagene autoleucel, and relmacabtagene autoleucel were compared with various standard of care chemotherapies. The incremental cost-effectiveness ratio (ICER) for CAR-T therapies ranged from $9424 to $4 124 105 per quality-adjusted life-year (QALY) in adults and from $20 784 to $243 177 per QALY in pediatric patients. Incremental cost-effectiveness ratios were found to improve over longer time horizons or when an earlier cure point was assumed. Most studies failed to meet the Philips checklist due to a lack of head-to-head comparisons and uncertainty surrounding CAR-T costs and curative effects. CONCLUSIONS: CAR-T therapies were more expensive and generated more QALYs than comparators, but their cost-effectiveness was uncertain and dependent on patient population, cancer type, and model assumptions. This highlights the need for more nuanced economic evaluations and continued research to better understand the value of CAR-T therapies in diverse patient populations.

Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.

BACKGROUND: Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies. METHODS: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items. RESULTS: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%). CONCLUSIONS: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.

Using an intersectionality lens to explore barriers and enablers to hepatitis C point-of-care testing: a qualitative study among people who inject drugs and service providers.

BACKGROUND: Hepatitis C virus (HCV) infection is a significant global health burden, particularly among people who inject drugs. Rapid point-of-care HCV testing has emerged as a promising approach to improve HCV detection and linkage to care in harm reduction organizations such as needle and syringe programs. The objective of this study was to use an intersectionality lens to explore the barriers and enablers to point-of-care HCV testing in a needle and syringe program. METHODS: A qualitative study was conducted using semi-structured interviews with clients (people who inject drugs) and service providers in a large community organization focused on the prevention of sexually transmitted and blood borne infections and harm reduction in Montreal, Canada. An intersectionality lens was used alongside the Theoretical Domains Framework to guide the formulation of research questions as well as data collection, analysis, and interpretation. RESULTS: We interviewed 27 participants (15 clients, 12 providers). For clients, four themes emerged: (1) understanding and perceptions of HCV testing, (2) the role of an accessible and inclusive environment, (3) the interplay of emotions and motivations in decision-making, and (4) the impact of intersectional stigma related to HCV, behaviors, and identities. For providers, five themes emerged: (1) knowledge, skills, and confidence for HCV testing, (2) professional roles and their intersection with identity and lived experience, (3) resources and integration of services, (4) social and emotional factors, and (5) behavioral regulation and incentives for HCV testing. Intersectional stigma amplified access, emotional and informational barriers to HCV care for clients. In contrast, identity and lived experience acted as powerful enablers for providers in the provision of HCV care. CONCLUSION: The application of an intersectionality lens provides a nuanced understanding of multilevel barriers and enablers to point-of-care HCV testing. Findings underscore the need for tailored strategies that address stigma, improve provider roles and communication, and foster an inclusive environment for equitable HCV care. Using an intersectionality lens in implementation research can offer valuable insights, guiding the design of equity-focused implementation strategies.

One size doesn't fit all: methodological reflections in conducting community-based behavioural science research to tailor COVID-19 vaccination initiatives for public health priority populations.

BACKGROUND: Promoting the uptake of vaccination for infectious diseases such as COVID-19 remains a global challenge, necessitating collaborative efforts between public health units (PHUs) and communities. Applied behavioural science can play a crucial role in supporting PHUs' response by providing insights into human behaviour and informing tailored strategies to enhance vaccination uptake. Community engagement can help broaden the reach of behavioural science research by involving a more diverse range of populations and ensuring that strategies better represent the needs of specific communities. We developed and applied an approach to conducting community-based behavioural science research with ethnically and socioeconomically diverse populations to guide PHUs in tailoring their strategies to promote COVID-19 vaccination. This paper presents the community engagement methodology and the lessons learned in applying the methodology. METHODS: The community engagement methodology was developed based on integrated knowledge translation (iKT) and community-based participatory research (CBPR) principles. The study involved collaboration with PHUs and local communities in Ontario, Canada to identify priority groups for COVID-19 vaccination, understand factors influencing vaccine uptake and co-design strategies tailored to each community to promote vaccination. Community engagement was conducted across three large urban regions with individuals from Eastern European communities, African, Black, and Caribbean communities and low socioeconomic neighbourhoods. RESULTS: We developed and applied a seven-step methodology for conducting community-based behavioural science research: (1) aligning goals with system-level partners; (2) engaging with PHUs to understand priorities; (3) understanding community strengths and dynamics; (4) building relationships with each community; (5) establishing partnerships (community advisory groups); (6) involving community members in the research process; and (7) feeding back and interpreting research findings. Research partnerships were successfully established with members of prioritized communities, enabling recruitment of participants for theory-informed behavioural science interviews, interpretation of findings, and co-design of targeted recommendations for each PHU to improve COVID-19 vaccination uptake. Lessons learned include the importance of cultural sensitivity and awareness of sociopolitical context in tailoring community engagement, being agile to address the diverse and evolving priorities of PHUs, and building trust to achieve effective community engagement. CONCLUSION: Effective community engagement in behavioural science research can lead to more inclusive and representative research. The community engagement approach developed and applied in this study acknowledges the diversity of communities, recognizes the central role of PHUs, and can help in addressing complex public health challenges.

The Quality in Acute Stroke Care (QASC) global scale-up using a cascading facilitation framework: a qualitative process evaluation.

BACKGROUND: Variation in hospital stroke care is problematic. The Quality in Acute Stroke (QASC) Australia trial demonstrated reductions in death and disability through supported implementation of nurse-led, evidence-based protocols to manage fever, hyperglycaemia (sugar) and swallowing (FeSS Protocols) following stroke. Subsequently, a pre-test/post-test study was conducted in acute stroke wards in 64 hospitals in 17 European countries to evaluate upscale of the FeSS Protocols. Implementation across countries was underpinned by a cascading facilitation framework of multi-stakeholder support involving academic partners and a not-for-profit health organisation, the Angels Initiative (the industry partner), that operates to promote evidence-based treatments in stroke centres. .We report here an a priori qualitative process evaluation undertaken to identify factors that influenced international implementation of the FeSS Protocols using a cascading facilitation framework. METHODS: The sampling frame for interviews was: (1) Executives/Steering Committee members, consisting of academics, the Angels Initiative and senior project team, (2) Angel Team leaders (managers of Angel Consultants), (3) Angel Consultants (responsible for assisting facilitation of FeSS Protocols into multiple hospitals) and (4) Country Co-ordinators (senior stroke nurses with country and hospital-level responsibilities for facilitating the introduction of the FeSS Protocols). A semi-structured interview elicited participant views on the factorsthat influenced engagement of stakeholders with the project and preparation for and implementation of the FeSS Protocol upscale. Interviews were recorded, transcribed verbatim and analysed inductively within NVivo. RESULTS: Individual (n = 13) and three group interviews (3 participants in each group) were undertaken. Three main themes with sub-themes were identified that represented key factors influencing upscale: (1) readiness for change (sub-themes: negotiating expectations; intervention feasible and acceptable; shared goal of evidence-based stroke management); (2) roles and relationships (sub-themes: defining and establishing roles; harnessing nurse champions) and (3) managing multiple changes (sub-themes: accommodating and responding to variation; more than clinical change; multi-layered communication framework). CONCLUSION: A cascading facilitation model involving a partnership between evidence producers (academic partners), knowledge brokers (industry partner, Angels Initiative) and evidence adopters (stroke clinicians) overcame multiple challenges involved in international evidence translation. Capacity to manage, negotiate and adapt to multi-level changes and strategic engagement of different stakeholders supported adoption of nurse-initiated stroke protocols within Europe. This model has promise for other large-scale evidence translation programs.

Implementation of an audit and feedback module targeting low-value clinical practices in a provincial trauma quality assurance program: a cost-effectiveness study.

BACKGROUND: Audit and Feedback (A&F) interventions based on quality indicators have been shown to lead to significant improvements in compliance with evidence-based care including de-adoption of low-value practices (LVPs). Our primary aim was to evaluate the cost-effectiveness of adding a hypothetical A&F module targeting LVPs for trauma admissions to an existing quality assurance intervention targeting high-value care and risk-adjusted outcomes. A secondary aim was to assess how certain A&F characteristics might influence its cost-effectiveness. METHODS: We conducted a cost-effectiveness analysis using a probabilistic static decision analytic model in the Québec trauma care continuum. We considered the Québec Ministry of Health perspective. Our economic evaluation compared a hypothetical scenario in which the A&F module targeting LVPs is implemented in a Canadian provincial trauma quality assurance program to a status quo scenario in which the A&F module is not implemented. In scenarios analyses we assessed the impact of A&F characteristics on its cost-effectiveness. Results are presented in terms of incremental costs per LVP avoided. RESULTS: Results suggest that the implementation of A&F module (Cost = $1,480,850; Number of LVPs = 6,005) is associated with higher costs and higher effectiveness compared to status quo (Cost = $1,124,661; Number of LVPs = 8,228). The A&F module would cost $160 per LVP avoided compared to status quo. The A&F module becomes more cost-effective with the addition of facilitation visits; more frequent evaluation; and when only high-volume trauma centers are considered. CONCLUSION: A&F module targeting LVPs is associated with higher costs and higher effectiveness than status quo and has the potential to be cost-effective if the decision-makers' willingness-to-pay is at least $160 per LVP avoided. This likely represents an underestimate of true ICER due to underestimated costs or missed opportunity costs. Results suggest that virtual facilitation visits, frequent evaluation, and implementing the module in high-volume centers can improve cost-effectiveness.

Developing a set of emergency department performance measures to evaluate delirium care quality for older adults: a modified e-Delphi study.

BACKGROUND: Older adults are at high risk of developing delirium in the emergency department (ED); however, it is under-recognized in routine clinical care. Lack of detection and treatment is associated with poor outcomes, such as mortality. Performance measures (PMs) are needed to identify variations in quality care to help guide improvement strategies. The purpose of this study is to gain consensus on a set of quality statements and PMs that can be used to evaluate delirium care quality for older ED patients. METHODS: A 3-round modified e-Delphi study was conducted with ED clinical experts. In each round, participants rated quality statements according to the concepts of importance and actionability, then their associated PMs according to the concept of necessity (1-9 Likert scales), with the ability to comment on each. Consensus and stability were evaluated using a priori criteria using descriptive statistics. Qualitative data was examined to identify themes within and across quality statements and PMs, which went through a participant validation exercise in the final round. RESULTS: Twenty-two experts participated, 95.5% were from west or central Canada. From 10 quality statements and 24 PMs, consensus was achieved for six quality statements and 22 PMs. Qualitative data supported justification for including three quality statements and one PM that achieved consensus slightly below a priori criteria. Three overarching themes emerged from the qualitative data related to quality statement actionability. Nine quality statements, nine structure PMs, and 14 process PMs are included in the final set, addressing four areas of delirium care: screening, diagnosis, risk reduction and management. CONCLUSION: Results provide a set of quality statements and PMs that are important, actionable, and necessary to a diverse group of clinical experts. To our knowledge, this is the first known study to develop a de novo set of guideline-based quality statements and PMs to evaluate the quality of delirium care older adults receive in the ED setting.

Quality improvement strategies for diabetes care: Effects on outcomes for adults living with diabetes.

BACKGROUND: There is a large body of evidence evaluating quality improvement (QI) programmes to improve care for adults living with diabetes. These programmes are often comprised of multiple QI strategies, which may be implemented in various combinations. Decision-makers planning to implement or evaluate a new QI programme, or both, need reliable evidence on the relative effectiveness of different QI strategies (individually and in combination) for different patient populations. OBJECTIVES: To update existing systematic reviews of diabetes QI programmes and apply novel meta-analytical techniques to estimate the effectiveness of QI strategies (individually and in combination) on diabetes quality of care. SEARCH METHODS: We searched databases (CENTRAL, MEDLINE, Embase and CINAHL) and trials registers (ClinicalTrials.gov and WHO ICTRP) to 4 June 2019. We conducted a top-up search to 23 September 2021; we screened these search results and 42 studies meeting our eligibility criteria are available in the awaiting classification section. SELECTION CRITERIA: We included randomised trials that assessed a QI programme to improve care in outpatient settings for people living with diabetes. QI programmes needed to evaluate at least one system- or provider-targeted QI strategy alone or in combination with a patient-targeted strategy. - System-targeted: case management (CM); team changes (TC); electronic patient registry (EPR); facilitated relay of clinical information (FR); continuous quality improvement (CQI). - Provider-targeted: audit and feedback (AF); clinician education (CE); clinician reminders (CR); financial incentives (FI). - Patient-targeted: patient education (PE); promotion of self-management (PSM); patient reminders (PR). Patient-targeted QI strategies needed to occur with a minimum of one provider or system-targeted strategy. DATA COLLECTION AND ANALYSIS: We dual-screened search results and abstracted data on study design, study population and QI strategies. We assessed the impact of the programmes on 13 measures of diabetes care, including: glycaemic control (e.g. mean glycated haemoglobin (HbA1c)); cardiovascular risk factor management (e.g. mean systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), proportion of people living with diabetes that quit smoking or receiving cardiovascular medications); and screening/prevention of microvascular complications (e.g. proportion of patients receiving retinopathy or foot screening); and harms (e.g. proportion of patients experiencing adverse hypoglycaemia or hyperglycaemia). We modelled the association of each QI strategy with outcomes using a series of hierarchical multivariable meta-regression models in a Bayesian framework. The previous version of this review identified that different strategies were more or less effective depending on baseline levels of outcomes. To explore this further, we extended the main additive model for continuous outcomes (HbA1c, SBP and LDL-C) to include an interaction term between each strategy and average baseline risk for each study (baseline thresholds were based on a data-driven approach; we used the median of all baseline values reported in the trials). Based on model diagnostics, the baseline interaction models for HbA1c, SBP and LDL-C performed better than the main model and are therefore presented as the primary analyses for these outcomes. Based on the model results, we qualitatively ordered each QI strategy within three tiers (Top, Middle, Bottom) based on its magnitude of effect relative to the other QI strategies, where 'Top' indicates that the QI strategy was likely one of the most effective strategies for that specific outcome. Secondary analyses explored the sensitivity of results to choices in model specification and priors.  Additional information about the methods and results of the review are available as Appendices in an online repository. This review will be maintained as a living systematic review; we will update our syntheses as more data become available. MAIN RESULTS: We identified 553 trials (428 patient-randomised and 125 cluster-randomised trials), including a total of 412,161 participants. Of the included studies, 66% involved people living with type 2 diabetes only. Participants were 50% female and the median age of participants was 58.4 years. The mean duration of follow-up was 12.5 months. HbA1c was the commonest reported outcome; screening outcomes and outcomes related to cardiovascular medications, smoking and harms were reported infrequently. The most frequently evaluated QI strategies across all study arms were PE, PSM and CM, while the least frequently evaluated QI strategies included AF, FI and CQI. Our confidence in the evidence is limited due to a lack of information on how studies were conducted.  Four QI strategies (CM, TC, PE, PSM) were consistently identified as 'Top' across the majority of outcomes. All QI strategies were ranked as 'Top' for at least one key outcome. The majority of effects of individual QI strategies were modest, but when used in combination could result in meaningful population-level improvements across the majority of outcomes. The median number of QI strategies in multicomponent QI programmes was three.  Combinations of the three most effective QI strategies were estimated to lead to the below effects:  - PR + PSM + CE: decrease in HbA1c by 0.41% (credibility interval (CrI) -0.61 to -0.22) when baseline HbA1c < 8.3%; - CM + PE + EPR: decrease in HbA1c by 0.62% (CrI -0.84 to -0.39) when baseline HbA1c > 8.3%;  - PE + TC + PSM: reduction in SBP by 2.14 mmHg (CrI -3.80 to -0.52) when baseline SBP < 136 mmHg; - CM + TC + PSM: reduction in SBP by 4.39 mmHg (CrI -6.20 to -2.56) when baseline SBP > 136 mmHg;  - TC + PE + CM: LDL-C lowering of 5.73 mg/dL (CrI -7.93 to -3.61) when baseline LDL < 107 mg/dL; - TC + CM + CR: LDL-C lowering by 5.52 mg/dL (CrI -9.24 to -1.89) when baseline LDL > 107 mg/dL. Assuming a baseline screening rate of 50%, the three most effective QI strategies were estimated to lead to an absolute improvement of 33% in retinopathy screening (PE + PR + TC) and 38% absolute increase in foot screening (PE + TC + Other). AUTHORS' CONCLUSIONS: There is a significant body of evidence about QI programmes to improve the management of diabetes. Multicomponent QI programmes for diabetes care (comprised of effective QI strategies) may achieve meaningful population-level improvements across the majority of outcomes. For health system decision-makers, the evidence summarised in this review can be used to identify strategies to include in QI programmes. For researchers, this synthesis identifies higher-priority QI strategies to examine in further research regarding how to optimise their evaluation and effects. We will maintain this as a living systematic review.

Audit and feedback interventions involving pharmacists to influence prescribing behaviour in general practice: a systematic review and meta-analysis.

INTRODUCTION: Pharmacists, as experts in medicines, are increasingly employed in general practices and undertake a range of responsibilities. Audit and feedback (A&F) interventions are effective in achieving behaviour change, including prescribing. The extent of pharmacist involvement in A&F interventions to influence prescribing is unknown. This review aimed to assess the effectiveness of A&F interventions involving pharmacists on prescribing in general practice compared with no A&F/usual care and to describe features of A&F interventions and pharmacist characteristics. METHODS: Electronic databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, (Social) Science Citation Indexes, ISI Web of Science) were searched (2012, 2019, 2020). Cochrane systematic review methods were applied to trial identification, selection, and risk of bias. Results were summarized descriptively and heterogeneity was assessed. A random-effects meta-analysis was conducted where studies were sufficiently homogenous in design and outcome. RESULTS: Eleven cluster-randomized studies from 9 countries were included. Risk of bias across most domains was low. Interventions focussed on older patients, specific clinical area(s), or specific medications. Meta-analysis of 6 studies showed improved prescribing outcomes (pooled risk ratio: 0.78, 95% confidence interval: 0.64-0.94). Interventions including both verbal and written feedback or computerized decision support for prescribers were more effective. Pharmacists who received study-specific training, provided ongoing support to prescribers or reviewed prescribing for individual patients, contributed to more effective interventions. CONCLUSIONS: A&F interventions involving pharmacists can lead to small improvements in evidence-based prescribing in general practice settings. Future implementation of A&F within general practice should compare different ways of involving pharmacists to determine how to optimize effectiveness.PRISMA-compliant abstract included in Supplementary Material 1.

Decision-makers' experiences with rapid evidence summaries to support real-time evidence informed decision-making in crises: a mixed methods study.

BACKGROUND: There is a clear need for research evidence to drive policymaking and emergency responses so that lives are saved and resources are not wasted. The need for evidence support for health and humanitarian crisis is even more pertinent because of the time and practical constraints that decision-makers in these settings face. To improve the use of research evidence in policy and practice, it is important to provide evidence resources tailored to the target audience. This study aims to gain real-world insights from decision-makers about how they use evidence summaries to inform real-time decision-making in crisis-settings, and to use our findings to improve the format of evidence summaries. METHODS: This study used an explanatory sequential mixed method study design. First, we used a survey to identify the views and experiences of those who were directly involved in crisis response in different contexts, and who may or may not have used evidence summaries. Second, we used the insights generated from the survey to help inform qualitative interviews with decision-makers in crisis-settings to derive an in-depth understanding of how they use evidence summaries and their desired format for evidence summaries. RESULTS: We interviewed 26 decision-makers working in health and humanitarian emergencies. The study identified challenges decision-makers face when trying to find and use research evidence in crises, including insufficient time and increased burden of responsibilities during crises, limited access to reliable internet connection, large volume of data not translated into user friendly summaries, and little information available on preparedness and response measures. Decision-makers preferred the following components in evidence summaries: title, target audience, presentation of key findings in an actionable checklist or infographic format, implementation considerations, assessment of the quality of evidence presented, citation and hyperlink to the full review, funding sources, language of full review, and other sources of information on the topic. Our study developed an evidence summary template with accompanying training material to inform real-time decision-making in crisis-settings. CONCLUSIONS: Our study provided a deeper understanding of the preferences of decision-makers working in health and humanitarian emergencies about the format of evidence summaries to enable real-time evidence informed decision-making.

The co-development of a linguistic and culturally tailored tele-retinopathy screening intervention for immigrants living with diabetes from China and African-Caribbean countries in Ottawa, Canada.

BACKGROUND: Diabetic retinopathy is a sight-threatening ocular complication of diabetes. Screening is an effective way to reduce severe complications, but screening attendance rates are often low, particularly for newcomers and immigrants to Canada and people from cultural and linguistic minority groups. Building on previous work, in partnership with patient and health system stakeholders, we co-developed a linguistically and culturally tailored tele-retinopathy screening intervention for people living with diabetes who recently immigrated to Canada from either China or African-Caribbean countries. METHODS: Following an environmental scan of diabetes eye care pathways in Ottawa, we conducted co-development workshops using a nominal group technique to create and prioritize personas of individuals requiring screening and identify barriers to screening that each persona may face. Next, we used the Theoretical Domains Framework to categorize the barriers/enablers and then mapped these categories to potential evidence-informed behaviour change techniques. Finally with these techniques in mind, participants prioritized strategies and channels of delivery, developed intervention content, and clarified actions required by different actors to overcome anticipated intervention delivery barriers. RESULTS: We carried out iterative co-development workshops with Mandarin and French-speaking individuals living with diabetes (i.e., patients in the community) who immigrated to Canada from China and African-Caribbean countries (n = 13), patient partners (n = 7), and health system partners (n = 6) recruited from community health centres in Ottawa. Patients in the community co-development workshops were conducted in Mandarin or French. Together, we prioritized five barriers to attending diabetic retinopathy screening: language (TDF Domains: skills, social influences), retinopathy familiarity (knowledge, beliefs about consequences), physician barriers regarding communication for screening (social influences), lack of publicity about screening (knowledge, environmental context and resources), and fitting screening around other activities (environmental context and resources). The resulting intervention included the following behaviour change techniques to address prioritized local barriers: information about health consequence, providing instructions on how to attend screening, prompts/cues, adding objects to the environment, social support, and restructuring the social environment. Operationalized delivery channels incorporated language support, pre-booking screening and sending reminders, social support via social media and community champions, and providing using flyers and videos as delivery channels. CONCLUSION: Working with intervention users and stakeholders, we co-developed a culturally and linguistically relevant tele-retinopathy intervention to address barriers to attending diabetic retinopathy screening and increase uptake among two under-served groups.

Living evidence and adaptive policy: perfect partners?

BACKGROUND: While there has been widespread global acceptance of the importance of evidence-informed policy, many opportunities to inform health policy with research are missed, often because of a mismatch between when and where reliable evidence is needed, and when and where it is available. 'Living evidence' is an approach where systematic evidence syntheses (e.g. living reviews, living guidelines, living policy briefs, etc.) are continually updated to incorporate new relevant evidence as it becomes available. Living evidence approaches have the potential to overcome a major barrier to evidence-informed policy, making up-to-date systematic summaries of policy-relevant research available at any time that policy-makers need them. These approaches are likely to be particularly beneficial given increasing calls for policy that is responsive, and rapidly adaptive to changes in the policy context. We describe the opportunities presented by living evidence for evidence-informed policy-making and highlight areas for further exploration. DISCUSSION: There are several elements of living approaches to evidence synthesis that might support increased and improved use of evidence to inform policy. Reviews are explicitly prioritised to be 'living' by partnerships between policy-makers and researchers based on relevance to decision-making, as well as uncertainty of existing evidence, and likelihood that new evidence will arise. The ongoing nature of the work means evidence synthesis teams can be dynamic and engage with policy-makers in a variety of ways over time; and synthesis topics, questions and methods can be adapted as policy interests or contextual factors shift. Policy-makers can sign-up to be notified when relevant new evidence is found, and can be confident that living syntheses are up-to-date and contain all research whenever they access them. The always up-to-date nature of living evidence syntheses means producers can rapidly demonstrate availability of relevant, reliable evidence when it is needed, addressing a frequently cited barrier to evidence-informed policymaking. CONCLUSIONS: While there are challenges to be overcome, living evidence provides opportunities to enable policy-makers to access up-to-date evidence whenever they need it and also enable researchers to respond to the issues of the day with up-to-date research; and update policy-makers on changes in the evidence base as they arise. It also provides an opportunity to build flexible partnerships between researchers and policy-makers to ensure that evidence syntheses reflect the changing needs of policy-makers.

Analyzing interprofessional teamwork in the operating room: An exploratory observational study using conventional and alternative approaches.

Intraoperative teamwork is vital for patient safety. Conventional tools for studying intraoperative teamwork typically rely on behaviorally anchored rating scales applied at the individual or team level, while others capture narrative information across several units of analysis. This prospective observational study characterizes teamwork using two conventional tools (Operating Theatre Team Non-Technical Skills Assessment Tool [NOTECHS]; Team Emergency Assessment Measure [TEAM]), and one alternative approach (modified-Systems Engineering Initiative for Patient Safety [SEIPS] model). We aimed to explore the advantages and disadvantages of each for providing feedback to improve teamwork practice. Fifty consecutive surgical cases at a Canadian academic hospital were recorded with the OR Black Box®, analyzed by trained raters, and summarized descriptively. Teamwork performance was consistently high within and across cases rated with NOTECHS and TEAMS. For cases analyzed with the modified-SEIPS tool, both optimal and suboptimal teamwork behaviors were identified, and team resilience was frequently observed. NOTECHS and TEAM provided summative assessments and overall pattern descriptions, while SEIPS facilitated a deeper understanding of teamwork processes. As healthcare organizations continue to prioritize teamwork improvement, SEIPS may provide valuable insights regarding teamwork behavior and the broader context influencing performance. This may ultimately enhance the development and effectiveness of multi-level teamwork interventions.

Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study.

BACKGROUND: Preliminary evidence suggests that providing longer duration prescriptions at discharge may improve long-term adherence to secondary preventative cardiac medications among post-myocardial infarction (MI) patients. We implemented and assessed the effects of two hospital-based interventions-(1) standardized prolonged discharge prescription forms (90-day supply with 3 repeats for recommended cardiac medications) plus education and (2) education only-on long-term cardiac medication adherence among elderly patients post-MI. METHODS: We conducted an interrupted time series study of all post-MI patients aged 65-104 years in Ontario, Canada, discharged from hospital between September 2015 and August 2018 with ≥ 1 dispensation(s) for a statin, beta blocker, angiotensin system inhibitor, and/or secondary antiplatelet within 7 days post-discharge. The standardized prolonged discharge prescription forms plus education and education-only interventions were implemented at 2 (1,414 patients) and 4 (926 patients) non-randomly selected hospitals in September 2017 for 12 months, with all other Ontario hospitals (n = 143; 18,556 patients) comprising an external control group. The primary outcome, long-term cardiac medication adherence, was defined at the patient-level as an average proportion of days covered (over 1-year post-discharge) ≥ 80% across cardiac medication classes dispensed at their index fill. Primary outcome data were aggregated within hospital groups (intervention 1, 2, or control) to monthly proportions and independently analyzed using segmented regression to evaluate intervention effects. A process evaluation was conducted to assess intervention fidelity. RESULTS: At 12 months post-implementation, there was no statistically significant effect on long-term cardiac medication adherence for either intervention-standardized prolonged discharge prescription forms plus education (5.4%; 95% CI - 6.4%, 17.2%) or education only (1.0%; 95% CI - 28.6%, 30.6%)-over and above the counterfactual trend; similarly, no change was observed in the control group (- 0.3%; 95% CI - 3.6%, 3.1%). During the intervention period, only 10.8% of patients in the intervention groups received ≥ 90 days, on average, for cardiac medications at their index fill. CONCLUSIONS: Recognizing intervention fidelity was low at the pharmacy level, and no statistically significant post-implementation differences in adherence were found, the trends in this study-coupled with other published retrospective analyses of administrative data-support further evaluation of this simple intervention to improve long-term adherence to cardiac medications. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03257579 , registered June 16, 2017 Protocol available at: https://pubmed.ncbi.nlm.nih.gov/33146624/ .

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial.

BACKGROUND: The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices. METHODS: We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention. RESULTS: The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery. CONCLUSIONS: Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration. TRIAL REGISTRATION: NCT03213171.

Barriers and enablers to diabetic eye screening attendance: An interview study with young adults with type 1 diabetes.

AIM: The aim of this study was to identify barriers and enablers of diabetic eye screening (DES) attendance amongst young adults with diabetes living in the United Kingdom. METHODS: Semistructured qualitative interviews with adults aged 18-34 years with diabetes. Participants were purposively sampled to aim for representation across gender, geographical locations, diabetes type, years since diabetes diagnosis and patterns of attendance (i.e. regular attenders, occasional non-attenders, regular non-attenders). Data were collected and analysed using the Theoretical Domains Framework (TDF) to explore potential individual, sociocultural and environmental influences on attendance. Data were analysed using a combined deductive and inductive thematic analysis approach. Barriers/enablers were mapped to behaviour change techniques (BCTs) to identify potential strategies to increase attendance. RESULTS: Key barriers to attendance reported by the sample of 29 study participants with type 1 diabetes, fell within the TDF domains: [Knowledge] (e.g. not understanding reasons for attending DES or treatments available if diabetic retinopathy is detected), [Social Influences] (e.g. lack of support following DES results), [Social role and Identity] (e.g. not knowing other people their age with diabetes, feeling 'isolated' and being reluctant to disclose their diabetes) and [Environmental Context and Resources] (e.g. lack of appointment flexibility and options for rescheduling). Enablers included: [Social Influences] (e.g. support of family/diabetes team), [Goals] (e.g. DES regarded as 'high priority'). Many of the reported barriers/enablers were consistent across groups. Potential BCTs to support attendance include Instructions on how to perform the behaviour; Information about health consequences; Social support (practical) and Social comparison. CONCLUSIONS: Attendance to diabetic eye screening in young adults is influenced by a complex set of interacting factors. Identification of potentially modifiable target behaviours provides a basis for designing more effective, tailored interventions to help young adults regularly attend eye screening and prevent avoidable vision loss.

Inappropriate use of clinical practices in Canada: a systematic review.

BACKGROUND: Inappropriate health care leads to negative patient experiences, poor health outcomes and inefficient use of resources. We aimed to conduct a systematic review of inappropriately used clinical practices in Canada. METHODS: We searched multiple bibliometric databases and grey literature to identify inappropriately used clinical practices in Canada between 2007 and 2021. Two team members independently screened citations, extracted data and assessed methodological quality. Findings were synthesized in 2 categories: diagnostics and therapeutics. We reported ranges of proportions of inappropriate use for all practices. Medians and interquartile ranges (IQRs), based on the percentage of patients not receiving recommended practices (underuse) or receiving practices not recommended (overuse), were calculated. All statistics are at the study summary level. RESULTS: We included 174 studies, representing 228 clinical practices and 28 900 762 patients. The median proportion of inappropriate care, as assessed in the studies, was 30.0% (IQR 12.0%-56.6%). Underuse (median 43.9%, IQR 23.8%-66.3%) was more frequent than overuse (median 13.6%, IQR 3.2%-30.7%). The most frequently investigated diagnostics were glycated hemoglobin (underused, range 18.0%-85.7%, n = 9) and thyroid-stimulating hormone (overused, range 3.0%-35.1%, n = 5). The most frequently investigated therapeutics were statin medications (underused, range 18.5%-71.0%, n = 6) and potentially inappropriate medications (overused, range 13.5%-97.3%, n = 9). INTERPRETATION: We have provided a summary of inappropriately used clinical practices in Canadian health care systems. Our findings can be used to support health care professionals and quality agencies to improve patient care and safety in Canada.