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.

Associations of preoperative anaemia with healthcare resource use and outcomes after colorectal surgery: a population-based cohort study.

BACKGROUND: Preoperative anaemia is common in patient undergoing colorectal surgery. Understanding the population-level costs of preoperative anaemia will inform development and evaluation of anaemia management at health system levels. METHODS: This was a population-based cohort study using linked, routinely collected data, including residents from Ontario, Canada, aged ≥18 yr who underwent an elective colorectal resection between 2012 and 2022. Primary exposure was preoperative anaemia (haemoglobin <130 g L-1 in males; <120 g L-1 in females). Primary outcome was 30-day costs in 2022 Canadian dollars (CAD), from the perspective of a publicly funded healthcare system. Secondary outcomes included red blood cell transfusion, major adverse events (MAEs), length of stay (LOS), days alive at home (DAH), and readmissions. RESULTS: We included 54,286 patients, with mean 65.3 (range 18-102) years of age and 49.0% females, among which 21 264 (39.2%) had preoperative anaemia. There was an absolute adjusted cost increase of $2671 per person at 30 days after surgery attributable to preoperative anaemia (ratio of means [RoM] 1.05, 95% confidence interval [CI] 1.04-1.06). Compared with the control group, 30-day risks of transfusion (odds ratio [OR] 4.34, 95% CI 4.04-4.66), MAEs (OR 1.14, 95% CI 1.03-1.27), LOS (RoM 1.08, 95% CI 1.07-1.10), and readmissions (OR 1.16, 95% CI 1.08-1.24) were higher in the anaemia group, with reduced DAH (RoM 0.95, 95% CI 0.95-0.96). CONCLUSIONS: Approximately $2671 CAD per person in 30-day health system costs are attributable to preoperative anaemia after colorectal surgery in Ontario, Canada.

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

OBJECTIVES: This study aims to systematically review evidence on the cost-effectiveness of chimeric antigen receptor (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 cancer patients 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 1,809 records, 47 of which were included. The majority 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 to various standard-of-care chemotherapies. The incremental cost-effective ratio (ICER) for CAR-T therapies ranged from $9,424 to $4,124,105 per QALY in adults and from $20,784 to $243,177 per QALY in pediatric patients. ICERs 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 were 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.

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.

How a Canadian federal organization integrated synoptic reporting and quality improvement tools to drive a national learning health system in cancer surgery.

Accurate and complete surgical and pathology reports are the cornerstone of treatment decisions and cancer care excellence. Synoptic reporting is a process for reporting specific data elements in a specific format in surgical and pathology reports. Since 2007, The Canadian Partnership Against Cancer has led the implementation of synoptic reporting mechanisms across multiple cancer disease sites and jurisdictions across Canada. While the implementation of synoptic reporting has been successful, its use to drive improvements in the quality of cancer care delivery has been lacking. Here we describe the Partnership's 4-year, national multi-jurisdictional quality improvement initiative to catalyse the use synoptic data to drive cancer system improvements. Resources provided to the jurisdictions included operational funding, training in quality improvement methodology, national forums, expert coaches, and ad hoc monitoring and support. The program emphasized foundational concepts including data literacy, audit and feedback reports, communities of practice, and positive deviance methodology.

Protocol for co-producing a framework and integrated resource platform for engaging patients in laboratory-based research.

BACKGROUND: Patient engagement in research is the meaningful and collaborative interaction between patients and researchers throughout the research process. Patient engagement can help to ensure patient-oriented values and perspectives are incorporated into the development, conduct, and dissemination of research. While patient engagement is increasingly prevalent in clinical research, it remains relatively unrealized in preclinical laboratory research. This may reflect the nature of preclinical research, in which routine interactions or engagement with patients may be less common. Our team of patient partners and researchers has previously identified few published examples of patient engagement in preclinical laboratory research, as well as a paucity of guidance on this topic. Here we propose the development of a process framework to facilitate patient engagement in preclinical laboratory research. METHODS: Our team, inclusive of researchers and patient partners, will develop a comprehensive, empirically-derived, and stakeholder-informed process framework for 'patient engagement in preclinical laboratory research.' First, our team will create a 'deliberative knowledge space' to conduct semi-structured discussions that will inform a draft framework for preclinical patient engagement. Over the course of several sessions, we will identify actions, activities, barriers, and enablers (e.g. considerations and motivations for patient engagement in preclinical laboratory research, define roles of key players). The resulting draft process framework will be further populated with examples and refined through an international consensus-building Delphi survey with patients, researchers, and other collaborator organizations. We will then conduct pilot field tests to evaluate the framework with preclinical laboratory research groups paired with patient partners. These results will be used to create a refined framework enriched with real-world examples and considerations. All resources developed will be made available through an online repository. DISCUSSION: Our proposed process framework will provide guidance, best practices, and standardized procedures to promote patient engagement in preclinical laboratory research. Supporting and facilitating patient engagement in this setting presents an exciting new opportunity to help realize the important impact that patients can make.

Engaging patients as partners or collaborators in clinical research is becoming more common, but it is still new in preclinical research. Preclinical researchers work in laboratories on cell and animal experiments. They traditionally don't have frequent interactions with patients compared to their clinical research colleagues. Integrating patient engagement in preclinical laboratory research may help ensure that patient perspectives and values are considered. To help preclinical laboratory research align with patient-centred priorities we propose the development of a practical framework. This framework will facilitate patient engagement in preclinical laboratory research. To achieve this, we will first hold in-depth discussions with patient partners, researchers, and other collaborators to understand views on patient engagement in preclinical laboratory research. Together, we will identify key considerations to draft a framework, including motivations for patient engagement in preclinical laboratory research, and defining the roles of those who need to be involved. We will refine the framework through an international survey where we will collect feedback from researchers, patient partners, and other collaborators to make further improvements. The framework will then be tested and refined by preclinical laboratory teams inclusive of patient partners. The finalized framework and other resources to facilitate patient engagement in preclinical laboratory research will be hosted in a 'one-stop-shop' of online resources. Ultimately, this framework will enable partnerships between patients and researchers and provide a roadmap for patient engagement in preclinical laboratory research. This presents an exciting new opportunity for patients and researchers to collaborate and potentially improve translation of laboratory-based research.

Development and validation of a theory-based questionnaire examining barriers and facilitators to discontinuing long-term benzodiazepine receptor agonist use.

BACKGROUND: Long-term use of benzodiazepine receptor agonists (BZRAs) is a persistent healthcare challenge and poses patient safety risks. Interventions underpinned by behaviour change theory are needed to support discontinuation of long-term BZRA use. The aim of this study was to develop and validate a questionnaire based on the Theoretical Domains Framework (TDF) to examine mediators of behaviour change relating to the discontinuation of long-term BZRA use. METHODS: An initial 52 item questionnaire was developed using the 14 domains of TDF version 2 and iteratively refined over two rounds. The questionnaire was disseminated online via online support groups that focused on BZRAs to community-based adults with either current or previous experience of taking BZRAs on a long-term basis (≥3 months). Confirmatory factor analysis was undertaken to assess the questionnaire's reliability, discriminant validity and goodness of fit. The Standardized Root Mean Square Residual (SRMR), Root Mean Square Error of Approximation (RMSEA) and Comparative Fit Index (CFI) were calculated. RESULTS: Following an iterative process of adjustment, the results obtained from confirmatory factor analysis resulted in the final questionnaire consisting of 29 items across nine theoretical domains. The internal consistency reliability values across these domains ranged from 0.62 to 0.85. For the final model, the SRMR was 0.23, the RMSEA was 0.11 and the CFI was 0.6. CONCLUSIONS: The questionnaire offers a potential tool that could be used to identify domains that need to be targeted as part of a behaviour change intervention at an individual patient level. Further research is needed to assess the questionnaire's acceptability and usability, and to develop a scoring system so that domains can be prioritised and subsequently targeted as part of an intervention.

Service-level barriers to and facilitators of accessibility to treatment for problematic alcohol use: a scoping review.

Introduction: Services to treat problematic alcohol use (PAU) should be highly accessible to optimize treatment engagement. We conducted a scoping review to map characteristics of services for the treatment of PAU that have been reported in the literature to be barriers to or facilitators of access to treatment from the perspective of individuals with PAU. Methods: A protocol was developed a priori, registered, and published. We searched MEDLINE®, Embase, the Cochrane Library, and additional grey literature sources from 2010 to April 2022 to identify primary qualitative research and surveys of adults with current or past PAU requiring treatment that were designed to identify modifiable characteristics of PAU treatment services (including psychosocial and pharmacologic interventions) that were perceived to be barriers to or facilitators of access to treatment. Studies of concurrent PAU and other substance use disorders were excluded. Study selection was performed by multiple review team members. Emergent barriers were coded and mapped to the accessibility dimensions of the Levesque framework of healthcare access, then descriptively summarized. Results: One-hundred-and-nine included studies reported an extensive array of unique service-level barriers that could act alone or together to prevent treatment accessibility. These included but were not limited to lack of an obvious entry point, complexity of the care pathway, high financial cost, unacceptably long wait times, lack of geographically accessible treatment, inconvenient appointment hours, poor cultural/demographic sensitivity, lack of anonymity/privacy, lack of services to treat concurrent PAU and mental health problems. Discussion: Barriers generally aligned with recent reviews of the substance use disorder literature. Ranking of barriers may be explored in a future discrete choice experiment of PAU service users. The rich qualitative findings of this review may support the design of new or modification of existing services for people with PAU to improve accessibility. Systematic Review Registration: Open Science Framework doi: 10.17605/OSF.IO/S849R.

Intraoperative Blood Management Strategies for Patients Undergoing Noncardiac Surgery: The Ottawa Intraoperative Transfusion Consensus.

Importance: There is marked variability in red blood cell (RBC) transfusion during the intraoperative period. The development and implementation of existing clinical practice guidelines have been ineffective in reducing this variability. Objective: To develop an internationally endorsed consensus statement about intraoperative transfusion in major noncardiac surgery. Evidence Review: A Delphi consensus survey technique with an anonymous 3-round iterative rating and feedback process was used. An expert panel of surgeons, anesthesiologists, and transfusion medicine specialists was recruited internationally. Statements were informed by extensive preparatory work, including a systematic reviews of intraoperative RBC guidelines and clinical trials, an interview study with patients to explore their perspectives about intraoperative transfusion, and interviews with physicians to understand the various behaviors that influence intraoperative transfusion decision-making. Thirty-eight statements were developed addressing (1) decision-making (interprofessional communication, clinical factors, procedural considerations, and audits), (2) restrictive transfusion strategies, (3) patient-centred considerations, and (4) research considerations (equipoise, outcomes, and protocol suspension). Panelists were asked to score statements on a 7-point Likert scale. Consensus was established with at least 75% agreement. Findings: The 34-member expert panel (14 of 33 women [42%]) included 16 anesthesiologists, 11 surgeons, and 7 transfusion specialists; panelists had a median of 16 years' experience (range, 2-50 years), mainly in Canada (52% [17 of 33]), the US (27% [9 of 33]), and Europe (15% [5 of 33]). The panel recommended routine preoperative and intraoperative discussion between surgeons and anesthesiologists about intraoperative RBC transfusion as well as postoperative review of intraoperative transfusion events. Point-of-care hemoglobin testing devices were recommended for transfusion guidance, alongside an algorithmic transfusion protocol with a restrictive hemoglobin trigger; however, more research is needed to evaluate the use of restrictive triggers in the operating room. Expert consensus recommended a detailed preoperative consent discussion with patients of the risks and benefits of both anemia and RBC transfusion and routine disclosure of intraoperative transfusion. Postoperative morbidity and mortality were recommended as the most relevant outcomes associated with intraoperative RBC transfusion, and transfusion triggers of 70 and 90 g/L were considered acceptable hemoglobin triggers to evaluate restrictive and liberal transfusion strategies, respectively, in clinical trials. Conclusions and Relevance: This consensus statement offers internationally endorsed expert guidance across several key domains on intraoperative RBC transfusion practice for noncardiac surgical procedures for which patients are at medium or high risk of bleeding. Future work should emphasize knowledge translation strategies to integrate these recommendations into routine clinical practice and transfusion research activities.

Point-of-care haemoglobin accuracy and transfusion outcomes in non-cardiac surgery at a Canadian tertiary academic hospital: protocol for the PREMISE observational study.

INTRODUCTION: Transfusions in surgery can be life-saving interventions, but inappropriate transfusions may lack clinical benefit and cause harm. Transfusion decision-making in surgery is complex and frequently informed by haemoglobin (Hgb) measurement in the operating room. Point-of-care testing for haemoglobin (POCT-Hgb) is increasingly relied on given its simplicity and rapid provision of results. POCT-Hgb devices lack adequate validation in the operative setting, particularly for Hgb values within the transfusion zone (60-100 g/L). This study aims to examine the accuracy of intraoperative POCT-Hgb instruments in non-cardiac surgery, and the association between POCT-Hgb measurements and transfusion decision-making. METHODS AND ANALYSIS: PREMISE is an observational prospective method comparison study. Enrolment will occur when adult patients undergoing major non-cardiac surgery require POCT-Hgb, as determined by the treating team. Three concurrent POCT-Hgb results, considered as index tests, will be compared with a laboratory analysis of Hgb (lab-Hgb), considered the gold standard. Participants may have multiple POCT-Hgb measurements during surgery. The primary outcome is the difference in individual Hgb measurements between POCT-Hgb and lab-Hgb, primarily among measurements that are within the transfusion zone. Secondary outcomes include POCT-Hgb accuracy within the entire cohort, postoperative morbidity, mortality and transfusion rates. The sample size is 1750 POCT-Hgb measurements to obtain a minimum of 652 Hgb measurements <100 g/L, based on an estimated incidence of 38%. The sample size was calculated to fit a logistic regression model to predict instances when POCT-Hgb are inaccurate, using 4 g/L as an acceptable margin of error. ETHICS AND DISSEMINATION: Institutional ethics approval has been obtained by the Ottawa Health Science Network-Research Ethics Board prior to initiating the study. Findings from this study will be published in peer-reviewed journals and presented at relevant scientific conferences. Social media will be leveraged to further disseminate the study results and engage with clinicians.

Barriers and enablers to and strategies for promoting domestic plasma donation throughout the world: Overarching protocol for three systematic reviews.

INTRODUCTION: The growing demand for plasma protein products has caused concern in many countries who largely rely on importing plasma products produced from plasma collected in the United States and Europe. Optimizing recruitment and retention of a diversity of plasma donors is therefore important for supporting national donation systems that can reliably meet the most critical needs of health services. This series of three systematic reviews aims to synthesize the known barriers and enablers to source plasma donation from the qualitative and survey-based literature and identify which strategies that have shown to be effective in promoting increased intention to, and actual donation of, source plasma. METHODS AND ANALYSIS: Primary studies involving source or convalescent plasma donation via plasmapheresis will be included. The search strategy will capture all potentially relevant studies to each of the three reviews, creating a database of plasma donation literature. Study designs will be subsequently identified in the screening process to facilitate analysis according to the unique inclusion criteria of each review (i.e., qualitative, survey, and experimental designs). The search will be conducted in the electronic databases SCOPUS, MEDLINE, EMBASE, PsycINFO, and CINAHL without date or language restrictions. Studies will be screened, and data will be extracted, in duplicate by two independent reviewers with disagreements resolved through consensus. Reviews 1 and 2 will draw on the Theoretical Domains Framework and Intersectionality, while Review 3 will be informed by Behaviour Change Intervention Ontologies. Directed content analysis and framework analysis (Review 1), and descriptive and inferential syntheses (Reviews 2 and 3), will be used, including meta-analyses if appropriate. DISCUSSION: This series of related reviews will serve to provide a foundation of what is known from the published literature about barriers and enablers to, and strategies for promoting, plasma donation worldwide.

Surfacing the causal assumptions and active ingredients of healthcare quality improvement interventions: An application to primary care opioid prescribing.

Background: Efforts to maximize the impact of healthcare improvement interventions are hampered when intervention components are not well defined or described, precluding the ability to understand how and why interventions are expected to work. Method: We partnered with two organizations delivering province-wide quality improvement interventions to establish how they envisaged their interventions lead to change (their underlying causal assumptions) and to identify active ingredients (behavior change techniques [BCTs]). The interventions assessed were an audit and feedback report and an academic detailing program. Both focused on supporting safer opioid prescribing in primary care in Ontario, Canada. Data collection involved semi-structured interviews with intervention developers (n = 8) and a content analysis of intervention documents. Analyses unpacked and articulated how the interventions were intended to achieve change and how this was operationalized. Results: Developers anticipated that the feedback report would provide physicians with a clear understanding of their own prescribing patterns in comparison to others. In the feedback report, we found an emphasis on BCTs consistent with that assumption (feedback on behavior; social comparison). The detailing was designed to provide tailored support to enable physicians to overcome barriers to change and to gradually enact specific practice changes for patients based on improved communication. In the detailing materials, we found an emphasis on instructions on how to perform the behavior, for a range of behaviors (e.g., tapering opioids, treating opioid use disorder). The materials were supplemented by detailer-enacted BCTs (e.g., social support [practical]; goal setting [behavior]; review behavioral goal[s]). Conclusions: The interventions included a small range of BCTs addressing various clinical behaviors. This work provides a methodological example of how to apply a behavioral lens to surface the active ingredients, target clinical behaviors, and causal assumptions of existing large-scale improvement interventions that could be applied in other contexts to optimize effectiveness and facilitate scale and spread.

What is already known about the topic?: The causal assumptions and key components of implementation interventions are often not well described, which limits the influence of implementation science on implementation practice. What does this paper add?: This work provides an approach for surfacing the causal assumptions from intervention developers (through interviews with eight participants) and active ingredients from intervention materials, focusing on two real-world interventions already delivered at scale and designed to promote safer opioid prescribing. The analysis provides a comprehensive intervention description and reveals the extent to which final interventions align with developers' intentions. What are the implications for practice, research, or policy?: The findings provide a foundation for future work which will describe the effectiveness of these interventions (alone and in combination) and explore whether they achieve change in the intended ways, thereby providing an example of a more fulsome intervention evaluation. More broadly, our methods can be used by implementation practitioners to review and reflect on their intervention development process and support comprehensive intervention descriptions.

Developing the intersectionality supplemented Consolidated Framework for Implementation Research (CFIR) and tools for intersectionality considerations.

BACKGROUND: The concept of intersectionality proposes that demographic and social constructs intersect with larger social structures of oppression and privilege to shape experiences. While intersectionality is a widely accepted concept in feminist and gender studies, there has been little attempt to use this lens in implementation science. We aimed to supplement the Consolidated Framework for Implementation Research (CFIR), a commonly used framework in implementation science, to support the incorporation of intersectionality in implementation science projects by (1) integrating an intersectional lens to the CFIR; and (2) developing a tool for researchers to be used alongside the updated framework. METHODS: Using a nominal group technique, an interdisciplinary framework committee (n = 17) prioritized the CFIR as one of three implementation science models, theories, and frameworks to supplement with intersectionality considerations; the modification of the other two frameworks are described in other papers. The CFIR subgroup (n = 7) reviewed the five domains and 26 constructs in the CFIR and prioritized domains and constructs for supplementation with intersectional considerations. The subgroup then iteratively developed recommendations and prompts for incorporating an intersectional approach within the prioritized domains and constructs. We developed recommendations and prompts to help researchers consider how personal identities and power structures may affect the facilitators and inhibitors of behavior change and the implementation of subsequent interventions. RESULTS: We achieved consensus on how to apply an intersectional lens to CFIR after six rounds of meetings. The final intersectionality supplemented CFIR includes the five original domains, and 28 constructs; the outer systems and structures and the outer cultures constructs were added to the outer setting domain. Intersectionality prompts were added to 13 of the 28 constructs. CONCLUSION: Through an expert-consensus approach, we modified the CFIR to include intersectionality considerations and developed a tool with prompts to help implementation users apply an intersectional lens using the updated framework.

Identifying behaviour change techniques in 287 randomized controlled trials of audit and feedback interventions targeting practice change among healthcare professionals.

BACKGROUND: Audit and feedback (A&F) is among the most widely used implementation strategies, providing healthcare professionals with summaries of their practice performance to prompt behaviour change and optimize care. Wide variability in effectiveness of A&F has spurred efforts to explore why some A&F interventions are more effective than others. Unpacking the variability of the content of A&F interventions in terms of their component behaviours change techniques (BCTs) may help advance our understanding of how A&F works best. This study aimed to systematically specify BCTs in A&F interventions targeting healthcare professional practice change. METHODS: We conducted a directed content analysis of intervention descriptions in 287 randomized trials included in an ongoing Cochrane systematic review update of A&F interventions (searched up to June 2020). Three trained researchers identified and categorized BCTs in all trial arms (treatment & control/comparator) using the 93-item BCT Taxonomy version 1. The original BCT definitions and examples in the taxonomy were adapted to include A&F-specific decision rules and examples. Two additional BCTs ('Education (unspecified)' and 'Feedback (unspecified)') were added, such that 95 BCTs were considered for coding. RESULTS: In total, 47/95 BCTs (49%) were identified across 360 treatment arms at least once (median = 5.0, IQR = 2.3, range = 129 per arm). The most common BCTs were 'Feedback on behaviour' (present 89% of the time; e.g. feedback on drug prescribing), 'Instruction on how to perform the behaviour' (71%; e.g. issuing a clinical guideline), 'Social comparison' (52%; e.g. feedback on performance of peers), 'Credible source' (41%; e.g. endorsements from respected professional body), and 'Education (unspecified)' (31%; e.g. giving a lecture to staff). A total of 130/287 (45%) control/comparator arms contained at least one BCT (median = 2.0, IQR = 3.0, range = 0-15 per arm), of which the most common were identical to those identified in treatment arms. CONCLUSIONS: A&F interventions to improve healthcare professional practice include a moderate range of BCTs, focusing predominantly on providing behavioural feedback, sharing guidelines, peer comparison data, education, and leveraging credible sources. We encourage the use of our A&F-specific list of BCTs to improve knowledge of what is being delivered in A&F interventions. Our study provides a basis for exploring which BCTs are associated with intervention effectiveness. TRIAL REGISTRATIONS: N/A.

Practice Facilitation to Support Family Physicians in Encouraging COVID-19 Vaccine Uptake: A Multimethod Process Evaluation.

PURPOSE: We offered a practice facilitation intervention to family physicians in Ontario, Canada, known to have large numbers of patients not yet vaccinated against coronavirus disease 2019 (COVID-19). METHODS: We conducted a multimethod process evaluation embedded within a randomized controlled trial (clinical trial #NCT05099497). We collected descriptive statistics regarding engagement and qualitative interview data from family physicians and practice facilitators, as well as data from facilitator field notes. We analyzed and triangulated the data using thematic analysis and mapped barriers to and enablers for implementation to structural, organizational, physician, and patient factors. RESULTS: Of the 300 approached, 90 family physicians (30%) accepted facilitation. Of these, 57% received technical support to identify unvaccinated patients, 29% used trained medical student volunteers to contact patients on their behalf, and 30% used automated calling to reach patients. Key factors affecting engagement with the intervention were staff shortages owing to COVID-19 (structural), clinic characteristics such as technical issues and gatekeeping by staff, which prevented facilitators from talking with physicians (organizational), burnout (physician), and specialized populations that required targeted resources (patient). The facilitator's ability to address technical issues and connect family physicians with medical students helped with engagement. CONCLUSIONS: Strategies to help underresourced family physicians serving high-needs populations for issues of public health importance, such as vaccine promotion, must acknowledge the scarcity of physicians' time and provide new resources. To successfully engage family physicians, practice facilitators should seek to build trust and relationships over time, including with front-office staff.

Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial.

Importance: Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant. Objectives: To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant. Design, Setting, and Participants: This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis). Interventions: Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders. Main Outcomes and Measures: The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor. Results: The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15). Conclusions and Relevance: This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort. Trial Registration: ClinicalTrials.gov Identifier: NCT03329521.

Engaging community members to ensure culturally specific language is used in research: should I use gay, queer, MSM, or this other new acronym?

Researchers often use terminology to define their participant groups that is rooted in a clinical understanding of the group's shared identity(ies). Such naming often ignores the ways that the individuals who comprise these populations identify themselves. One oft-cited benefit of patient-oriented or community-engaged research is that language is local and relevant to impacted communities. This paper aims to contribute to the literature on how this local and relevant language can best be established. We ask how researchers can identify and implement accurate terminology, even when divergent perspectives exist within the communities involved. We draw from our experience with the Expanding Plasma Donation in Canada study, a community-engaged research study, which explored the views of people impacted by the "men who have sex with men" (MSM) blood donation policies in Canada. We describe the collaborative process through which we came to a consensual naming of this population, the challenges we faced, and a set of guiding principles we used to address them. We did not find an all-encompassing term or acronym that worked for all stages of research. Instead, we offer a set of guiding principles that can aid researchers engaging in a similar process: harm reduction, consent and transparency, collaboration and community involvement, recognition of missing voices, and resisting and/or restructuring oppressive standards.

The words and labels that researchers use to describe the communities they study does not always resonate with the actual members of those communities. Doing research in partnership with members of socially disadvantaged groups can help to ensure that the language used in the research is relevant, accurate, and respectful. Researchers studying issues related to men who have sex with men often struggle with knowing what term to use to describe this group of people. While many people may identify as "gay", "queer", "bisexual", or any other term, there are many men who do not identify with these labels but also have sex with men. Previous research on this topic is usually focused on arguing that a specific term or acronym should be adopted. As part of a larger research program to support more inclusive plasma donation, the current paper describes the process our research team undertook to ethically describe this complex community of diverse men who have sex with men. Rather than choosing one specific label to describe the community members in all situations, we describe a set of guiding principles that can be used to help researchers flexibly navigate language depending on the situation and context.

Assessing the feasibility, acceptability, and fidelity of a tele-retinopathy-based intervention to encourage greater attendance to diabetic retinopathy screening in immigrants living with diabetes from China and African-Caribbean countries in Ottawa, Canada: a protocol.

BACKGROUND: Diabetic retinopathy is a leading cause of preventable blindness in Canada. Clinical guidelines recommend annual diabetic retinopathy screening for people living with diabetes to reduce the risk and progression of vision loss. However, many Canadians with diabetes do not attend screening. Screening rates are even lower in immigrants to Canada including people from China, Africa, and the Caribbean, and these groups are also at higher risk of developing diabetes complications. We aim to assess the feasibility, acceptability, and fidelity of a co-developed, linguistically and culturally tailored tele-retinopathy screening intervention for Mandarin-speaking immigrants from China and French-speaking immigrants from African-Caribbean countries living with diabetes in Ottawa, Canada, and identify how many from each population group attend screening during the pilot period. METHODS: We will work with our health system and patient partners to conduct a 6-month feasibility pilot of a tele-retinopathy screening intervention in a Community Health Centre in Ottawa. We anticipate recruiting 50-150 patients and 5-10 health care providers involved in delivering the intervention for the pilot. Acceptability will be assessed via a Theoretical Framework of Acceptability-informed survey with patients and health care providers. To assess feasibility, we will use a Theoretical Domains Framework-informed interview guide and to assess fidelity, and we will use a survey informed by the National Institutes of Health framework from the perspective of health care providers. We will also collect patient demographics (i.e., age, gender, ethnicity, health insurance status, and immigration information), screening outcomes (i.e., patients with retinopathy identified, patients requiring specialist care), patient costs, and other intervention-related variables such as preferred language. Survey data will be descriptively analyzed and qualitative data will undergo content analysis. DISCUSSION: This feasibility pilot study will capture how many people living with diabetes from each group attend the diabetic retinopathy screening, costs, and implementation processes for the tele-retinopathy screening intervention. The study will indicate the practicability and suitability of the intervention in increasing screening attendance in the target population groups. The study results will inform a patient-randomized trial, provide evidence to conduct an economic evaluation of the intervention, and optimize the community-based intervention.

Exploring COVID-19 education to support vaccine confidence amongst the general adult population with special considerations for healthcare and long-term care staff: A scoping review.

Background: Despite the demonstrated efficacy of approved COVID-19 vaccines, high levels of hesitancy were observed in the first few months of the COVID-19 vaccines' rollout. Factors contributing to vaccine hesitancy are well-described in the literature. Among the various strategies for promoting vaccine confidence, educational interventions provide a foundationally and widely implemented set of approaches for supporting individuals in their vaccine decisions. However, the evidence around the measurable impact of various educational strategies to improve vaccine confidence is limited. We conducted a scoping review with the aim of exploring and characterizing educational interventions delivered during the pandemic to support COVID-19 vaccine confidence in adults. Methods: We developed a search strategy with a medical information scientist and searched five databases, including Ovid MEDLINE and Web of Science, as well as grey literature. We considered all study designs and reports. Interventions delivered to children or adolescents, interventions on non-COVID-19 vaccines, as well as national or mass vaccination campaigns without documented interaction(s) between facilitator(s) and a specific audience were excluded. Articles were independently screened by three reviewers. After screening 4602 titles and abstracts and 174 full-text articles across two rounds of searches, 22 articles met our inclusion criteria. Ten additional studies were identified through hand searching. Data from included studies were charted and results were described narratively. Results: We included 32 studies and synthesized their educational delivery structure, participants (i.e., facilitators and priority audience), and content. Formal, group-based presentations were the most common type of educational intervention in the included studies (75%). A third of studies (34%) used multiple strategies, with many formal group-based presentations being coupled with additional individual-based interventions (29%). Given the novelty of the COVID-19 vaccines and the unique current context, studies reported personalized conversations, question periods, and addressing misinformation as important components of the educational approaches reviewed. Conclusions: Various educational interventions were delivered during the COVID-19 pandemic, with many initiatives involving multifaceted interventions utilizing both formal and informal approaches that leveraged community (cultural, religious) partnerships when developing and facilitating COVID-19 vaccine education. Train-the-trainer approaches with recognized community members could be of value as trust and personal connections were identified as strong enablers throughout the review.