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Introduction Some laboratory testing practices may be of low value, leading to wasted resources and potential patient harm. Our scoping review investigated factors and processes that developers report using to inform decisions about what tests to target for practice improvement. Methods We searched Medline on May 30th, 2019 and June 28th, 2021 and included guidelines, recommendation statements, or empirical studies related to test ordering practices. Studies were included if they were conducted in a tertiary care setting, reported making a choice about a specific test requiring intervention, and reported at least one factor informing that choice. We extracted descriptive details, tests chosen, processes used to make the choice, and factors guiding test choice. Results From 114 eligible studies, we identified 30 factors related to test choice including clinical value, cost, prevalence of test, quality of test, and actionability of test results. We identified nine different processes used to inform decisions regarding where to spend intervention resources. Conclusions Intervention developers face difficult choices when deciding where to put scarce resources intended to improve test utilization. Factors and processes identified here can be used to inform a framework to help intervention developers make choices relevant to improving testing practices.

Haemodialysis centres have conventionally provided maintenance haemodialysis using a standard dialysate temperature (eg, 36·5°C) for all patients. Many centres now use cooler dialysate (eg, 36·0°C or lower) for potential cardiovascular benefits. We aimed to assess whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate.MyTEMP was a pragmatic, two-arm, parallel-group, registry-based, open-label, cluster-randomised, superiority trial done at haemodialysis centres in Ontario, Canada. Eligible centres provided maintenance haemodialysis to at least 15 patients a week, and the medical director of each centre had to confirm that their centre would deliver the assigned intervention. Using covariate-constrained randomisation, we allocated 84 centres (1:1) to use either personalised cooler dialysate (nurses set the dialysate temperature 0·5-0·9°C below each patient's measured pre-dialysis body temperature, with a lowest recommended dialysate temperature of 35·5°C), or standard temperature dialysate (36·5°C for all patients and treatments). Patients and health-care providers were not masked to the group assignment; however, the primary outcome was recorded in provincial databases by medical coders who were unaware of the trial or the centres' group assignment. The primary composite outcome was cardiovascular-related death or hospital admission with myocardial infarction, ischaemic stroke, or congestive heart failure during the 4-year trial period. Analysis was by intention to treat. The study is registered at ClinicalTrials.gov, NCT02628366.We assessed all of Ontario's 97 centres for inclusion into the study. Nine centres had less than 15 patients and one director requested that four of their seven centres not participate. 84 centres were recruited and on Feb 1, 2017, these centres were randomly assigned to administer personalised cooler dialysate (42 centres) or standard temperature dialysate (42 centres). The intervention period was from April 3, 2017, to March 31, 2021, and during this time the trial centres provided outpatient maintenance haemodialysis to 15 413 patients (about 4·3 million haemodialysis treatments). The mean dialysate temperature was 35·8°C in the cooler dialysate group and 36·4°C in the standard temperature group. The primary outcome occurred in 1711 (21·4%) of 8000 patients in the cooler dialysate group versus 1658 (22·4%) of 7413 patients in the standard temperature group (adjusted hazard ratio 1·00, 96% CI 0·89 to 1·11; p=0·93). The mean drop in intradialytic systolic blood pressure was 26·6 mm Hg in the cooler dialysate group and 27·1 mm Hg in the standard temperature group (mean difference -0·5 mm Hg, 99% CI -1·4 to 0·4; p=0·14).Centre-wide delivery of personalised cooler dialysate did not significantly reduce the risk of major cardiovascular events compared with standard temperature dialysate. The rising popularity of cooler dialysate is called into question by this study, and the risks and benefits of cooler dialysate in some patient populations should be clarified in future trials.Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Ontario Renal Network, Ontario Strategy for Patient-Oriented Research Support Unit, Dialysis Clinic, Inc., ICES (formerly known as the Institute for Clinical Evaluative Sciences), Lawson Health Research Institute, and Western University.

The purpose of this study is to characterize contemporary Canadian health psychology through an environmental scan by identifying faculty, research productivity and strengths, and collaborator interconnectivity. Profiles at Canadian universities were reviewed for faculty with psychology doctorates and health psychology research programs. Publications were obtained through Google Scholar and PubMed (Jan/18–Mar/21). A total of 284 faculty were identified. Cancer, pain, and sleep were key research topics. The collaborator network analysis revealed that most were linked through a common network, with clusters organized around geography, topic, and trainee relationships. Canada is a unique and productive contributor to health psychology.

Background While audit & feedback (A&F) is an effective implementation intervention, the design elements which maximize effectiveness are unclear. Partnering with a healthcare quality advisory organization already delivering feedback, we conducted a pragmatic, 2 × 2 factorial, cluster-randomized trial to test the impact of variations in two factors: (A) the benchmark used for comparison and (B) information framing. An embedded process evaluation explored hypothesized mechanisms of effect. Methods Eligible physicians worked in nursing homes in Ontario, Canada, and had voluntarily signed up to receive the report. Groups of nursing homes sharing physicians were randomized to (A) physicians’ individual prescribing rates compared to top-performing peers (the top quartile) or the provincial median and (B) risk-framed information (reporting the number of patients prescribed high-risk medication) or benefit-framed information (reporting the number of patients not prescribed). We hypothesized that the top quartile comparator and risk-framing would lead to greater practice improvements. The primary outcome was the mean number of central nervous system-active medications per resident per month. Primary analyses compared the four arms at 6 months post-intervention. Factorial analyses were secondary. The process evaluation comprised a follow-up questionnaire and semi-structured interviews. Results Two hundred sixty-seven physicians (152 clusters) were randomized: 67 to arm 1 (median benchmark, benefit framing), 65 to arm 2 (top quartile benchmark, benefit framing), 75 to arm 3 (median benchmark, risk framing), and 60 to arm 4 (top quartile benchmark, risk framing). There were no significant differences in the primary outcome across arms or for each factor. However, engagement was low (27–31% of physicians across arms downloaded the report). The process evaluation indicated that both factors minimally impacted the proposed mechanisms. However, risk-framed feedback was perceived as more actionable and more compatible with current workflows, whilst a higher target might encourage behaviour change when physicians identified with the comparator. Conclusions Risk framing and a top quartile comparator have the potential to achieve change. Further work to establish the strategies most likely to enhance A&F engagement, particularly with physicians who may be most likely to benefit from feedback, is required to support meaningfully addressing intricate research questions concerning the design of A&F. Trial registration ClinicalTrials.gov, NCT02979964. Registered 29 November 2016.

Background Health behaviors such as physical inactivity, unhealthy eating, smoking tobacco, and alcohol use are each leading risk factors for non-communicable chronic disease. Better understanding which behaviors tend to co-occur (i.e., cluster together) and co-vary (i.e., are correlated) may provide novel opportunities to develop more comprehensive interventions to promote multiple health behavior change. However, whether co-occurrence or co-variation-based approaches are better suited for this task remains relatively unknown. Purpose To compare the utility of co-occurrence vs. co-variation-based approaches for understanding the interconnectedness between multiple health-impacting behaviors. Methods Using baseline and follow-up data (N = 40,268) from the Canadian Longitudinal Study of Aging, we examined the co-occurrence and co-variation of health behaviors. We used cluster analysis to group individuals based on their behavioral tendencies across multiple behaviors and to examine how these clusters are associated with demographic characteristics and health indicators. We compared outputs from cluster analysis to behavioral correlations and compared regression analyses of clusters and individual behaviors predicting future health outcomes. Results Seven clusters were identified, with clusters differentiated by six of the seven health behaviors included in the analysis. Sociodemographic characteristics varied across several clusters. Correlations between behaviors were generally small. In regression analyses individual behaviors accounted for more variance in health outcomes than clusters. Conclusions Co-occurrence-based approaches may be more suitable for identifying sub-groups for intervention targeting while co-variation approaches are more suitable for building an understanding of the relationships between health behaviors.

Background Canada has incrementally reduced restrictions to blood and plasma donation that impact men who have sex with men, gay, bisexual, and queer men, and some Two Spirit, transgender and non-binary individuals (MSM/2SGBTQ+). Prior to the launch of a pilot program in 2021 enabling some MSM/2SGBTQ + to donate source plasma, we explored the acceptability of the program among individuals who could become eligible to donate in the program. Methods We invited men identifying as MSM/2SGBTQ + to participate in two consecutive semi-structured interviews to explore their views on blood and plasma donation policy, plasma donation, and the proposed Canadian plasma donation program. Interview transcripts were analyzed thematically and acceptability-related themes were mapped onto the Theoretical Framework of Acceptability. Results Twenty-seven men identifying as having sex with men participated in 53 interviews. Eighteen themes were mapped onto the seven construct domains of the Theoretical Framework of Acceptability. Underlying all aspects of acceptability was a tension between four primary values influencing participants’ views: altruism, equity, supply sufficiency, and evidence-based policy. The program was viewed as welcome progress on a discriminatory policy, with many excited to participate, yet tension with inequitable aspects of the program undermined support for the program and interest to contribute to it. The high demands of the program are unique for MSM/2SGBTQ + and are only tolerable as part of a program that is an incremental and instrumental step to more equitable donation policies. Conclusion Findings highlight past experiences of exclusion in Canada as a unique and critical part of the context of the donation experience among MSM/2SGBTQ+. Despite the program’s goals of greater inclusivity of MSM/2SGBTQ + individuals, the anticipated experience of the program included continued stigmatization and inequities. Future research should seek to understand the experienced views of MSM/2SGBTQ + donors to ensure that as policies change, policies are implemented equitably.

Background National clinical audit programmes aim to improve patient care by reviewing performance against explicit standards and directing action towards areas not meeting those standards. Their impact can be improved by (1) optimising feedback content and format, (2) strengthening audit cycles and (3) embedding randomised trials evaluating different ways of delivering feedback. Objectives The objectives were to (1) develop and evaluate the effects of modifications to feedback on recipient responses, (2) identify ways of strengthening feedback cycles for two national audits and (3) explore opportunities, costs and benefits of national audit participation in a programme of trials. Design An online fractional factorial screening experiment (objective 1) and qualitative interviews (objectives 2 and 3). Setting and participants Participants were clinicians and managers involved in five national clinical audits – the National Comparative Audit of Blood Transfusions, the Paediatric Intensive Care Audit Network, the Myocardial Ischaemia National Audit Project, the Trauma Audit & Research Network and the National Diabetes Audit – (objective 1); and clinicians, members of the public and researchers (objectives 2 and 3). Interventions We selected and developed six online feedback modifications through three rounds of user testing. We randomised participants to one of 32 combinations of the following recommended specific actions: comparators reinforcing desired behaviour change; multimodal feedback; minimised extraneous cognitive load for feedback recipients; short, actionable messages followed by optional detail; and incorporating ‘the patient voice’ (objective 1). Main outcome measures The outcomes were intended actions, including enactment of audit standards (primary outcome), comprehension, user experience and engagement (objective 1). Results For objective 1, the primary analysis included 638 randomised participants, of whom 566 completed the outcome questionnaire. No modification independently increased intended enactment of audit standards. Minimised cognitive load improved comprehension (+0.1; p = 0.014) and plans to bring audit findings to colleagues’ attention (+0.13, on a –3 to +3 scale; p = 0.016). We observed important cumulative synergistic and antagonistic interactions between modifications, participant role and national audit. The analysis in objective 2 included 19 interviews assessing the Trauma Audit Research Network and the National Diabetes Audit. The identified ways of strengthening audit cycles included making performance data easier to understand and guiding action planning. The analysis in objective 3 identified four conditions for effective collaboration from 31 interviews: compromise – recognising capacity and constraints; logistics – enabling data sharing, audit quality and funding; leadership – engaging local stakeholders; and relationships – agreeing shared priorities and needs. The perceived benefits of collaboration outweighed the risks. Limitations The online experiment assessed intended enactment as a predictor of actual clinical behaviour. Interviews and surveys were subject to social desirability bias. Conclusions National audit impacts may be enhanced by strengthening all aspects of feedback cycles, particularly effective feedback, and considering how different ways of reinforcing feedback act together. Future work Embedded randomised trials evaluating different ways of delivering feedback within national clinical audits are acceptable and may offer efficient, evidence-based and cumulative improvements in outcomes. Trial registration This trial is registered as ISRCTN41584028. Funding details This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 15. See the NIHR Journals Library website for further project information.

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.

While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of behavioral influences during recruitment is in tension with the ethical principle of respect for persons, as at least some of these influences could be used to manipulate potential participants. In this paper, we examine this tension by discussing two types of behavioral influences: one example involves physician recommendations, and the other involves framing of information to exploit cognitive biases. We argue that despite the apparent tension with ethical principles, influencing trial participants through behavior change strategies can be ethically acceptable. However, we argue that trialists have a positive obligation to analyze their recruitment strategies for behavioral influences and disclose these upfront to the research ethics committee. But we also acknowledge that since neither trialists nor ethics committees are presently well equipped to perform these analyses, additional resources and guidance are needed. We close by outlining a path toward the development of such guidance.

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 attended 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 six-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, we will use a survey informed by the National Institutes of Health Behaviour Change 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.

Tailored interventions have been shown to be effective and tailoring is a popular process with intuitive appeal for researchers and practitioners. However, the concept and process are ill-defined in implementation science. Descriptions of how tailoring has been applied in practice are often absent or insufficient in detail. This lack of transparency makes it difficult to synthesize and replicate efforts. It also hides the trade-offs for researchers and practitioners that are inherent in the process. In this article we juxtapose the growing prominence of tailoring with four key questions surrounding the process. Specifically, we ask: (1) what constitutes tailoring and when does it begin and end?; (2) how is it expected to work?; (3) who and what does the tailoring process involve?; and (4) how should tailoring be evaluated? We discuss these questions as a call to action for better reporting and further research to bring clarity, consistency, and coherence to tailoring, a key process in implementation science.

Access to commercial CD19 CAR-T cells remains limited even in wealthy countries like Canada due to clinical, logistical, and financial barriers related to centrally manufactured products. We created a non-commercial academic platform for end-to-end manufacturing of CAR-T cells within Canada’s publicly funded healthcare system. We report initial results from a single-arm, open-label study to determine the safety and efficacy of in-house manufactured CD19 CAR-T cells (entitled CLIC-1901) in participants with relapsed/refractory CD19 positive hematologic malignancies. Using a GMP compliant semi-automated, closed process on the Miltenyi Prodigy, T cells were transduced with lentiviral vector bearing a 4-1BB anti-CD19 CAR transgene and expanded. Participants underwent lymphodepletion with fludarabine and cyclophosphamide, followed by infusion of non-cryopreserved CAR-T cells. Thirty participants with non-Hodgkin’s lymphoma (n=25) or acute lymphoblastic leukemia (n=5) were infused with CLIC-1901: 21 males (70%), median age 66 (range 18-75). Time from enrollment to CLIC-1901 infusion was a median of 20 days (range 15-48). The median CLIC-1901 dose infused was 2.3 × 106 CAR-T cells/kg (range 0.13-3.6 × 106/kg). Toxicity included ≥ grade 3 cytokine release syndrome (n=2) and neurotoxicity (n=1). Median follow-up was 6.5 months. Overall response rate at day 28 was 76.7%. Median progression-free and overall survival was 6 months (95%CI 3-not estimable) and 11 months (95% 6.6-not estimable), respectively. This is the first trial of in-house manufactured CAR-T cells in Canada and demonstrates that administering fresh CLIC-1901 product is fast, safe, and efficacious. Our experience may provide helpful guidance for other jurisdictions seeking to create feasible and sustainable CAR-T cell programs in research-oriented yet resource-constrained settings.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03765177, identifier NCT03765177.

Background: Under-recruitment regularly impedes clinical trials, leading to wasted resources and opportunity costs. Methods for designing trial participation strategies rarely consider behavior change theory. Objective: Informed by the Theoretical Domains Framework, we identified factors important to participating in Huntington’s disease research and provide examples of how such a theory-informed approach can make specific suggestions about how to design targeted recruitment strategies. Methods: We identified a range of trial participation barriers and enablers based on interviews of key informants and implemented an online survey of members of the Huntington’s disease community, asking them to rate the extent to which different factors would affect likelihood to participate in a generic Huntington’s disease trial. Results: From 4,195 members, we received 323 responses and 243 completed surveys (323/4,195 or 8% participation, 243/323 or 75% completion). Respondents endorsed 9 barriers and 23 enablers relevant to trial participation. Most frequently endorsed barriers were travel to the study site (69%), worry about unknown side effects (65%), trial documents being difficult to understand (64%), and participation affecting other activities (49%). Enablers included optimism about likelihood of trial participation leading to a cure (98%), helping others (98%), contributing to science (97%), and having helpful people available to help with the participation decision (89%). Conclusion: Our theory-informed survey to identify barriers to and enablers of Huntington’s disease trial participation identified 32 factors, from 13 theoretical domains relevant to trial participation, and suggests effective approaches for improving trial participation and patient experience.

Background Efforts to generate evidence for implementation strategies are frustrated by insufficient description. The Expert Recommendations for Implementing Change (ERIC) compilation names and defines implementation strategies; however, further work is needed to describe the actions involved. One potentially complementary taxonomy is the behaviour change techniques (BCT) taxonomy. We aimed to examine the extent and nature of the overlap between these taxonomies. Methods Definitions and descriptions of 73 strategies in the ERIC compilation were analysed. First, each description was deductively coded using the BCT taxonomy. Second, a typology was developed to categorise the extent of overlap between ERIC strategies and BCTs. Third, three implementation scientists independently rated their level of agreement with the categorisation and BCT coding. Finally, discrepancies were settled through online consensus discussions. Additional patterns of complementarity between ERIC strategies and BCTs were labelled thematically. Descriptive statistics summarise the frequency of coded BCTs and the number of strategies mapped to each of the categories of the typology. Results Across the 73 strategies, 41/93 BCTs (44%) were coded, with ‘restructuring the social environment’ as the most frequently coded (n=18 strategies, 25%). There was direct overlap between one strategy (change physical structure and equipment) and one BCT (‘restructuring physical environment’). Most strategy descriptions (n=64) had BCTs that were clearly indicated (n=18), and others where BCTs were probable but not explicitly described (n=31) or indicated multiple types of overlap (n=15). For some strategies, the presence of additional BCTs was dependent on the form of delivery. Some strategies served as examples of broad BCTs operationalised for implementation. For eight strategies, there were no BCTs indicated, or they did not appear to focus on changing behaviour. These strategies reflected preparatory stages and targeted collective cognition at the system level rather than behaviour change at the service delivery level. Conclusions This study demonstrates how the ERIC compilation and BCT taxonomy can be integrated to specify active ingredients, providing an opportunity to better understand mechanisms of action. Our results highlight complementarity rather than redundancy. More efforts to integrate these or other taxonomies will aid strategy developers and build links between existing silos in implementation science.

ObjectivesTo audit all publications produced by Montreal Neurological Institute-Hospital researchers regarding open science practices and to survey Neuro-based researchers about barriers and facilitators to data sharing.Setting, design and participantsIn the first study, we retrieved 313 unique publications and collated all Neuro publications from 2019 and extracted information from each article pertaining to data sharing and other open science practices. We included all empirical papers and pre-prints that were reported in English. In the second study, one hundred twenty-four participants (out of 553) completed the survey, a response rate of 22.42%. We surveyed all Neuro researchers.Primary and secondary outcomesfor the audit we examined data sharing and open science practices. For the survey, we asked participants about their data sharing practices.ResultsWe found that 66.5% of these publications (n=208) included a data sharing statement. Overall, 74.5% (n=155) of articles had data that was publicly available. When examining broader open science practices, rates of compliance tended to be lower. For example, 94.9% (n=297) of publications failed to register a protocol. Among participants who had published a first or last authored paper in the past year, most participants, 53 of 74 (71.62%), reported that they had openly shared their research data. Less than half of the participants 37.50% (n=45) reported having engaged in training related to data sharing within the last 12 months.ConclusionWe found that half of all publications included in the audit shared data. Participants indicated an appetite for resources for learning about data sharing signaling a willingness to perform better.Strengths and limitations of this studyTo serve as a baseline to benchmark for improvements in data sharing and other open science practicesTo measure progress over time.The results of the study cannot be generalized.It is hard to measure changes in the community.

Background Models, theories, and frameworks (MTFs) provide the foundation for a cumulative science of implementation, reflecting a shared, evolving understanding of various facets of implementation. One under-represented aspect in implementation MTFs is how intersecting social factors and systems of power and oppression can shape implementation. There is value in enhancing how MTFs in implementation research and practice account for these intersecting factors. Given the large number of MTFs, we sought to identify exemplar MTFs that represent key implementation phases within which to embed an intersectional perspective. Methods We used a five-step process to prioritize MTFs for enhancement with an intersectional lens. We mapped 160 MTFs to three previously prioritized phases of the Knowledge-to-Action (KTA) framework. Next, 17 implementation researchers/practitioners, MTF experts, and intersectionality experts agreed on criteria for prioritizing MTFs within each KTA phase. The experts used a modified Delphi process to agree on an exemplar MTF for each of the three prioritized KTA framework phases. Finally, we reached consensus on the final MTFs and contacted the original MTF developers to confirm MTF versions and explore additional insights. Results We agreed on three criteria when prioritizing MTFs: acceptability (mean = 3.20, SD = 0.75), applicability (mean = 3.82, SD = 0.72), and usability (median = 4.00, mean = 3.89, SD = 0.31) of the MTF. The top-rated MTFs were the Iowa Model of Evidence-Based Practice to Promote Quality Care for the ‘Identify the problem’ phase (mean = 4.57, SD = 2.31), the Consolidated Framework for Implementation Research for the ‘Assess barriers/facilitators to knowledge use’ phase (mean = 5.79, SD = 1.12), and the Behaviour Change Wheel for the ‘Select, tailor, implement interventions’ phase (mean = 6.36, SD = 1.08). Conclusions Our interdisciplinary team engaged in a rigorous process to reach consensus on MTFs reflecting specific phases of the implementation process and prioritized each to serve as an exemplar in which to embed intersectional approaches. The resulting MTFs correspond with specific phases of the KTA framework, which itself may be useful for those seeking particular MTFs for particular KTA phases. This approach also provides a template for how other implementation MTFs could be similarly considered in the future. Trial registration Open Science Framework Registration: osf.io/qgh64.

Traditionally, economic evaluations have engaged clinicians and policymakers; however, patients and their caregivers have insight that can ensure that the economic evaluation process appropriately reflects disease consequences and adequately addresses their priorities related to treatment.We aimed to identify patient priorities to inform an early economic evaluation of chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia.We conducted two online group discussions of four participants each, involving patients with experience of hematological cancer and a caregiver. We used an adapted version of the nominal group technique, a consensus-building discussion approach, to generate focused qualitative data.Patients and a caregiver acknowledged both the costs directly related to clinical care, such as the out-of-pocket cost of drugs, and the indirect treatment costs, such as the cost of transport, accommodation, and food. The emotional and physical toll of treatment and the influence of treatment on employment and education were additional costs emphasized by participants. Treatment benefits prioritized by participants included the efficacy of treatment, manageable side effects, improved quality of life, accessibility of treatment, and short treatment duration.Engaging patients and caregivers in an early economic evaluation could help identify additional costs and benefits of therapies that are not typically recognized in economic evaluations but have the potential to increase the commercial viability of novel therapies. This research also demonstrates how patients and caregivers can be engaged at different levels in the development of early economic evaluation models.

Healthcare professional (HCP) behaviours are actions performed by individuals and teams for varying and often complex patient needs. However, gaps exist between evidence-informed care behaviours and the care provided. Implementation science seeks to develop generalizable principles and approaches to investigate and address care gaps, supporting HCP behaviour change while building a cumulative science. We highlight theory-informed approaches for defining HCP behaviour and investigating the prevalence of evidence-based care and known correlates and interventions to change professional practice. Behavioural sciences can be applied to develop implementation strategies to support HCP behaviour change and provide valid, reliable tools to evaluate these strategies. There are thousands of different behaviours performed by different HCPs across many contexts, requiring different implementation approaches. HCP behaviours can include activities related to promoting health and preventing illness, assessing and diagnosing illnesses, providing treatments, managing health conditions, managing the healthcare system and building therapeutic alliances. The key challenge is optimising behaviour change interventions that address barriers to and enablers of recommended practice. HCP behaviours may be determined by, but not limited to, Knowledge, Social influences, Intention, Emotions and Goals. Understanding HCP behaviour change is a critical to ensuring advances in health psychology are applied to maximize population health.

Background Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. Methods The study employed the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. Results The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) ‘Identify and prepare champions’, (2) ‘Conduct local needs assessment’, (3) ‘Conduct educational meetings’, (4) ‘Inform local opinion leaders’, (5) ‘Build a coalition’, (6) ‘Promote adaptability’, (7) ‘Develop a formal implementation blueprint’, (8) ‘Involve patients/consumers and family members’, (9) ‘Obtain and use patients/consumers and family feedback’, (10) ‘Develop educational materials’, (11) ‘Promote network weaving’, (12) ‘Distribute educational materials’, (13) ‘Access new funding’ and (14) ‘Develop academic partnerships’. Conclusion This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.

Cell‐based therapies hold promise to substantially curb complications from extreme preterm birth, the main cause of death in children below the age of 5 years. Exciting preclinical studies in experimental neonatal lung injury have provided the impetus for the initiation of early phase clinical trials in extreme preterm infants at risk of developing bronchopulmonary dysplasia. Clinical translation of promising therapies, however, is slow and often fails. In the adult population, results of clinical trials so far have not matched the enticing preclinical data. The neonatal field has experienced many hard‐earned lessons with the implementation of oxygen therapy or postnatal steroids. Here we briefly summarize the preclinical data that have permitted the initiation of early phase clinical trials of cell‐based therapies in extreme preterm infants and describe the INCuBAToR concept (Innovative Neonatal Cellular Therapy for Bronchopulmonary Dysplasia: Accelerating Translation of Research), an evidence‐based approach to mitigate the risk of translating advanced therapies into this vulnerable patient population. The INCuBAToR addresses several of the shortcomings at the preclinical and the clinical stage that usually contribute to the failure of clinical translation through (a) systematic reviews of preclinical and clinical studies, (b) integrated knowledge transfer through engaging important stakeholders early on, (c) early economic evaluation to determine if a novel therapy is viable, and (d) retrospective and prospective studies to define and test ideal eligibility criteria to optimize clinical trial design. The INCuBAToR concept can be applied to any novel therapy in order to enhance the likelihood of success of clinical translation in a timely, transparent, rigorous, and evidence‐based fashion., The INCuBAToR is a framework built into the classical clinical translation pathway from laboratory discovery to human trials. It is designed to mitigate the risk of translating cell therapies into the clinic by providing an evidence‐based approach. Systematic reviews, integrated knowledge translation, early economic evaluation, and retro‐ and prospective observational cohort studies can substantially enhance success of the clinical translation.

BackgroundMandates and recommendations related to embedding open science practices within the research lifecycle are increasingly common. Few stakeholders, however, are monitoring compliance to their mandates or recommendations. It is necessary to monitor the current state of open science to track changes over time and to identify areas to create interventions to drive improvements.Monitoring open science practices requires that they are defined and operationalized. Involving the biomedical community, we sought to reach consensus on a core set of open science practices to monitor at biomedical research institutions.Methods and FindingsTo establish consensus in a structured and systematic fashion, we conducted a modified 3-round Delphi study. Participants in Round 1 were 80 individuals from 20 biomedical research institutions that exhibit interest in or actively support open science. Participants were research administrators, researchers, specialists in dedicated open science roles, and librarians. In Rounds 1 and 2, participants completed an online survey evaluating a set of potential open science practices that could be important and meaningful to monitor in an automated institutional open science dashboard. Participants voted on the inclusion of each item and provided a rationale for their choice. We defined consensus as 80% agreement. Between rounds, participants received aggregated voting scores for each item and anonymized comments from all participants, and were asked to re-vote on items that did not reach consensus. For Round 3, we hosted two half- day virtual meetings with 21 and 17 participants respectively to discuss and vote on all items that had not reached consensus after Round 2. Ultimately, participants reached consensus to include a 19 open science practices.ConclusionsA group of international stakeholders used a modified Delphi process to agree upon open science practices to monitor in a proposed open science dashboard for biomedical institutions. The core set of 19 open science practices identified by participants will form the foundation for institutional dashboards that display compliance with open science practices. They will now be assessed and tested for automatic inclusion in terms of technical feasibility. Using user-centered design, participating institutions will be involved in creating a dashboard prototype, which can then be implemented to monitor rates of open science practices at biomedical institutions. Our methods and approach may also transfer to other research settings–other disciplines could consider using our consensus list as a starting point for agreement upon a discipline-specific set of open science practices to monitor. The findings may also be of broader value to the development of policy, education, and interventions.

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant.To prespecify the statistical analysis plan for the EnAKT LKD trial.The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters").Twenty-six CKD programs in Ontario, Canada.More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant.The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders.The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor.Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs.The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases.The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521).Version 1.0 August 26, 2022.EnAKT LKD est une intervention d’amélioration de la qualité visant à améliorer l’accès à la transplantation rénale et au don vivant de rein. Nous avons mené un essai clinique randomisé par grappes afin d’évaluer l’effet de l’intervention, par rapport aux soins habituels, sur le taux d’étapes clés réalisées dans le processus de réception d’une greffe de rein.Exposer les grandes lignes du plan d’analyse statistique de l’essai EAKT LKD.EAKT LKD est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. La randomisation a été réalisée au niveau des programmes d’insuffisance rénale chronique (IRC) (les « grappes »).26 programmes d’IRC en Ontario (Canada).Plus de 10 000 patients atteints d’IRC de stade avancé (des patients approchant le besoin de dialyse ou recevant une hémodialyse d’entretien) sans contre-indication documentée à la greffe rénale.Les données de l’essai (y compris les caractéristiques et les résultats des patients) seront obtenues à partir de bases de données administratives en santé (le « registre »). La randomisation stratifiée avec contraintes de covariables a servi à répartir les 26 programmes d’IRC (1:1) selon qu’ils allaient fournir l’intervention ou les soins habituels entre le 1er novembre 2017 et le 31 décembre 2021 (4,17 ans). Les programmes d’IRC du bras d’intervention ont eu droit au soutien suivant: (1) des équipes locales d’amélioration de la qualité et du soutien administratif; (2) de l’information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien de la part de receveurs et de donneurs vivants; et (4) des rapports sur le rendement au niveau du programme et une surveillance assurée par les chefs de programme.Le principal critère d’évaluation est le taux d’étapes clés accomplies vers la réception d’une greffe de rein, où jusqu’à quatre étapes uniques par patient seront comptabilisées: (1) le patient est aiguillé vers un centre de transplantation pour évaluation; (2) un possible donneur vivant de rein contacte un centre de transplantation pour un receveur en particulier et amorce son évaluation; (3) le patient est ajouté à la liste d’attente pour une transplantation d’un donneur décédé, et (4) le patient reçoit une greffe de rein d’un donneur vivant ou décédé.Selon une approche fondée sur l’intention de traiter, le critère d’évaluation principal sera analysé au niveau du patient en utilisant un modèle multiétats contraint, corrigé dans les programmes d’IRC en fonction du regroupement.L’essai EnAKT LKD s’est tenu du 1er novembre 2017 au 31 décembre 2021. Nous analyserons les résultats et en rendrons compte dès que les données seront disponibles dans les bases de données administratives couplées du système de santé.

Use of rigorous study design methods and transparent reporting in publications are 2 key strategies proposed to improve the reproducibility of preclinical research. Despite promotion of these practices by funders and journals, assessments suggest uptake is low in preclinical research. Thirty preclinical scientists were interviewed to better understand barriers and enablers to rigorous design and reporting. The interview guide was informed by the Theoretical Domains Framework, which is a framework used to understand determinants of current and desired behavior. Four global themes were identified; 2 reflecting enablers and 2 reflecting barriers. We found that basic scientists are highly motivated to apply the methods of rigorous design and reporting and perceive a number of benefits to their adoption (e.g., improved quality and reliability). However, there was varied awareness of the guidelines and in implementation of these practices. Researchers also noted that these guidelines can result in disadvantages, such as increased sample sizes, expenses, time, and can require several personnel to operationalize. Most researchers expressed additional resources such as personnel and education/training would better enable the application of some methods. Using existing guidance (Behaviour Change Wheel (BCW); Expert Recommendations for Implementing Change (ERIC) project implementation strategies), we mapped and coded our interview findings to identify potential interventions, policies, and implementation strategies to improve routine use of the guidelines by preclinical scientists. These findings will help inform specific strategies that may guide the development of programs and resources to improve experimental design and transparent reporting in preclinical research.

Self-management is recommended for addressing chronic conditions, and self-management programmes improve health behaviours and outcomes. However, social and economic factors have been neglected in self-management research, despite their relevance for marginalized groups. Thus, we aimed to explore barriers and facilitators that influence self-management among socioeconomically marginalized people who use drugs (PWUD).Using community-based participatory methods, we developed a qualitative interview guide and conducted peer-led recruitment. Participants were admitted into the study after self-identifying as using non-prescribed drugs, having a chronic health issue, and experiencing socioeconomic marginalization. Data were analysed using reflexive thematic analysis, taking a relational autonomy lens.Participants highlighted substantial barriers to managing their health issues, mostly stemming from their social and economic environments, such as unstable housing, low income, lack of supportive social networks, and negative healthcare experiences. Participants also described how their ability to self-manage their chronic conditions benefited from specific aspects of social interactions, including close relationships, community connectedness, and engaging in peer support.Our findings suggest that structural interventions are needed to support self-management among marginalized PWUD, especially stable housing. Self-management supports for PWUD would benefit from including a range of low-barrier community-based options, peer work opportunities, and advocacy for needs.

BackgroundMultiple health behaviour change (MHBC) interventions are proposed to be an effective and efficient way of intervening to manage and/or prevent chronic conditions, both with patients (targeting health-related behaviours, e.g. diet, smoking) and healthcare professionals (targeting clinical behaviours, e.g. advice, examine). However, their effectiveness is still unclear. Therefore, a review of these interventions in this context is warranted. Two interrelated systematic reviews of MHBC interventions will be conducted, one targeting health-related behaviours of patients with chronic conditions and another one targeting clinical behaviours of healthcare professionals.Materials and methods These systematic reviews will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic search for MHBC interventions for patients will be performed in Web of Science, PubMed, CINAHL, EMBASE and Cochrane, and a systematic search for healthcare professionals will be conducted in the same databases. Studies from previous reviews will also be consulted. We will include randomised trials, in which interventions aim to change more than one behaviour (health-related for patients, clinical for HCPs). Components of the interventions will be extracted by using existing standardised classifications, such as ontologies (e.g. mode of delivery) and taxonomies (e.g. behaviour change techniques taxonomy v1), and the Cochrane Collaboration revised tool of Risk of Bias will be applied to perform risk of bias assessment. The components of included interventions will be synthesised and links between them will be mapped to identify trends and gaps. If sufficient comparable studies are included, a meta-analysis will be performed in both reviews. Systematic reviews registrationsCRD42022327085 and CRD42022327108

BACKGROUND: A solution for increasing the number of available organs for transplantation is to encourage more individuals to register a commitment for deceased organ donation. However, the percentage of the population registered for organ donation remains low in many countries. OBJECTIVES: To evaluate the benefits and harms of various interventions used to increase deceased organ donor registration. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 11 August 2020 through contact with an Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: We included all randomised controlled trials (RCTs), cluster RCTs and quasi‐RCTs of interventions to promote deceased organ donor registration. We included studies if they measured self‐reported or verified donor registration, intention to donate, intention to register a decision or number of individuals signing donor cards as outcomes. DATA COLLECTION AND ANALYSIS: Two authors independently assessed retrieved studies and extracted data from included studies. We assessed studies for risk of bias. We obtained summary estimates of effect using a random‐effects model and expressed results as risk ratios (RR) (95% confidence intervals; CI) for dichotomous outcomes and mean difference (MD; 95% CI) or standardised mean difference (SMD; 95% CI) for continuous outcomes. In multi‐arm trials, data were pooled to create single pair‐wise comparisons. Analyses were stratified by specific intervention setting where available. MAIN RESULTS: Our search strategy identified 46 studies (47 primary articles, including one abstract) comprising 24 parallel RCTs, 19 cluster RCTs and 3 quasi‐RCTs. Sample sizes ranged from 138 to 1,085,292 (median = 514). A total of 16 studies measured registration behaviour, 27 measured intention to register/donate and three studies measured both registration behaviour and intention to register. Interventions were delivered in a variety of different settings: schools (14 studies), driver’s motor vehicle (DMV) centres (5), mail‐outs (4), primary care centres (3), workplaces (1), community settings (7) and general public (12). Interventions were highly varied in terms of their content and included strategies such as educational sessions and videos, leveraging peer leaders, staff training, message framing, and priming. Most studies were rated as having high or unclear risk of bias for random sequence generation and allocation concealment and low risk for the remainder of the domains. Data from 34/46 studies (74%) were available for meta‐analysis. Low certainty evidence showed organ donation registration interventions had a small overall effect on improving registration behaviour (16 studies, 1,294,065 participants: RR 1.30, 95% CI 1.19 to 1.43, I(2) = 84%), intention to register/donate (dichotomous) (10 studies, 10,838 participants: RR 1.21, 95% CI 1.03 to 1.42, I(2) = 91%) and intention to register/donate (continuous) (9 studies, 3572 participants: SMD 0.23, 95% CI 0.11 to 0.36, I(2) = 67%). Classroom‐based interventions delivered in a lecture format by individuals from the transplant community may be effective at increasing intention to register/donate (3 studies, 675 participants: RR 1.33, 95% CI 1.15 to 1.55, I² = 0%). Community interventions targeting specific ethnic groups were generally effective at increasing registration rates (k = 5, n = 4186; RR 2.14, 95% CI 1.35 to 3.40, I² = 85%), although heterogeneity was high. In particular, interventions delivered in the community by trained peer‐leaders appear to be effective (3 studies, 3819 participant: RR 2.09, 95% CI 1.08 to 4.06, I² = 87%), although again, the data lacked robustness. There was some evidence that framing messages (e.g. anticipated regret) and priming individuals (e.g. reciprocity) in a certain way may increase intention to register/donate, however, few studies measured this effect on actual registration. Overall, the studies varied significantly in terms of design, setting, content and delivery. Selection bias was evident and a quarter of the studies could not be included in the meta‐analysis due to incomplete outcome data reporting. No adverse events were reported. AUTHORS' CONCLUSIONS: In our review, we identified a variety of approaches used to increase organ donor registration including school‐based educational sessions and videos, leveraging peer leaders in the community, DMV staff training, targeted messaging and priming. The variability in outcome measures used and incompleteness in reporting meant that most data could not be combined for analysis. When data were combined, overall effect sizes were small in favour of intervention groups over controls, however, there was significant variability in the data. There was some evidence that leveraging peer‐leaders in the community to deliver organ donation education may improve registration rates and classroom‐based education from credible individuals (i.e. members of the transplant community) may improve intention to register/donate, however, there is no clear evidence favouring any particular approach. There was mixed evidence for simple, low‐intensity interventions utilising message framing and priming. However, it is likely that interest in these strategies will persist due to their reach and scalability. Further research is therefore required to adequately address the question of the most effective interventions for increasing deceased organ donor registration.

Canadian Blood Services introduced new eligibility criteria that allows some sexually active gay, bisexual, and other men who have sex with men (gbMSM) to donate source plasma, marking a significant change from time-based deferral criteria. We aimed to identify potential barriers and enablers to implementing the new criteria from the perspective of donor center staff.We conducted Theoretical Domains Framework-informed interviews with staff from two source plasma donation centers in Canada.We completed 28 interviews between June 2020 and April 2021. Three themes representing eight domains captured key tensions. Valuing inclusive eligibility criteria: staff support inclusive criteria; many were concerned the new criteria remained discriminatory. Investing in positive donor experiences: staff wished to foster positive donor experiences; however, they worried gbMSM donors would express anger and disappointment regarding the new criteria, staff would experience unease over using stigmatizing criteria and convey nonverbal cues of discomfort, and recurring plasma donors may behave inappropriately. Supporting education, training, and transparency of eligibility criteria: participants believed providing in-person training (i.e., to explain criteria rationale, address discomfort, practice responding to donor questions) and ensuring donors and the public were well-informed of the upcoming changes would improve implementation.Participant views emphasize the importance of supporting staff through training and transparent communication to optimize the delivery of world-class equitable care for a new cohort of donors who have previously been excluded from plasma donation. Findings inform which staff supports to consider to improve implementation as policies continue to shift internationally.

Engaging patients as partners in the design and execution of early-phase clinical trials offers a unique opportunity to ensure patient perspectives are considered. Here we describe our experience partnering with four individuals with lived experience of blood cancer to co-develop documents and services to support participants of an early-phase trial. Through regular team meetings, patient partners co-developed a visual informed consent document and a non-technical summary of the informed consent document to facilitate participant understanding of trial procedures. Overall, patient partners highlighted important trial components that would not have been identified without their input.

Background A failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention. Methods This study was informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions were described and developed in a co-design workshop with trial participants. Acceptability and feasibility (guided by (by the Theoretical Framework of Acceptability) of two prioritised retention interventions was explored during a focus group involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). Following focus group discussions stakeholders completed an intervention acceptability questionnaire. Results Eight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed: (1) incentives and rewards for follow-up clinic attendance, (2) goal setting for improving questionnaire return, (3) participant self-monitoring to improve questionnaire return and/or clinic attendance, and (4) motivational information to improve questionnaire return and clinic attendance. Eighteen trial stakeholders discussed the two prioritised interventions. The motivational information intervention was deemed acceptable and considered straightforward to implement whilst the goal setting intervention was viewed as less clear and less acceptable. Conclusions This is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess effectiveness.

Self-management programs improve health outcomes and self-management is recommended for chronic conditions. Yet chronic disease self-management supports have rarely been applied to people who use drugs (PWUD). Thus, our objective was to explore self-management experiences among marginalized PWUD. We used community-based participatory methods and conducted qualitative interviews. Participants self-identified as having long-term and past year experience using non-prescribed drugs, one other chronic condition, and socioeconomic marginalization. We analyzed the data using reflexive thematic analysis. Although many participants considered drug use a chronic health issue, self-medicating with non-prescribed drugs was also a key self-management strategy to address other health issues. Participants also described numerous other strategies, including cognitive and behavioral tactics. These findings highlight the need for a safe supply of pharmaceutical-grade drugs to support self-management among marginalized PWUD. Self-management supports should also be tailored to address relevant topics (e.g., harm reduction, withdrawal), include creative activities, and not hinder PWUD’s agency.

BACKGROUND Individuals with type 1 diabetes (T1D) are more likely to achieve optimal glycemic control when they have frequent visits with their healthcare team. There is a potential benefit of frequent, telemedicine interventions as an effective strategy to lower hemoglobin A1c (HbA1c). OBJECTIVE To understand the provider- and system-level factors affecting successful implementation of a virtual care intervention into type 1 diabetes (T1D) clinics. METHODS Semi-structured interviews with managers and certified diabetes educators (CDEs) at diabetes clinics across Southern Ontario, prior to the COVID-19 pandemic. Deductive analysis using the Theoretical Domains Framework, then mapping to Behaviour Change Techniques to inform potential implementation strategies for high frequency virtual care for T1D. RESULTS There was considerable intention to deliver high frequency virtual care to patients with T1D. Participants believed that this model of care could lead to improved patient outcomes and engagement, but would likely increase the workload of CDEs. Some felt there were insufficient resources at their site to enable them to participate in the program. Member-checking conducted during the pandemic revealed that clinics and staff had already developed strategies to overcome resource barriers to the adoption of virtual care during the pandemic. CONCLUSIONS Existing enablers for high frequency virtual care can be leveraged, and barriers can be overcome with targeted clinical incentives and support.

Background Individuals with type 1 diabetes (T1D) are more likely to achieve optimal glycemic management when they have frequent visits with their health care team. There is a potential benefit of frequent, telemedicine interventions as an effective strategy to lower hemoglobin A1c (HbA1c). Objective The objective is this study was to understand the provider- and system-level factors affecting the successful implementation of a virtual care intervention in type 1 diabetes (T1D) clinics. Methods Semistructured interviews were conducted with managers and certified diabetes educators (CDEs) at diabetes clinics across Southern Ontario before the COVID-19 pandemic. Deductive analysis was carried out using the Theoretical Domains Framework, followed by mapping to behavior change techniques to inform potential implementation strategies for high-frequency virtual care for T1D. Results There was considerable intention to deliver high-frequency virtual care to patients with T1D. Participants believed that this model of care could lead to improved patient outcomes and engagement but would likely increase the workload of CDEs. Some felt there were insufficient resources at their site to enable them to participate in the program. Member checking conducted during the pandemic revealed that clinics and staff had already developed strategies to overcome resource barriers to the adoption of virtual care during the pandemic. Conclusions Existing enablers for high-frequency virtual care for T1D can be leveraged, and barriers can be overcome with targeted clinical incentives and support.

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

Background The demand for peer reviewers is often perceived as disproportionate to the supply and availability of reviewers. Considering characteristics associated with peer review behaviour can allow for the development of solutions to manage the growing demand for peer reviewers. The objective of this research was to compare characteristics among two groups of reviewers registered in Publons. Methods A descriptive cross-sectional study design was used to compare characteristics between (1) individuals completing at least 100 peer reviews (‘mega peer reviewers’) from January 2018 to December 2018 as and (2) a control group of peer reviewers completing between 1 and 18 peer reviews over the same time period. Data was provided by Publons, which offers a repository of peer reviewer activities in addition to tracking peer reviewer publications and research metrics. Mann Whitney tests and chi-square tests were conducted comparing characteristics (e.g., number of publications, number of citations, word count of peer review) of mega peer reviewers to the control group of reviewers. Results A total of 1596 peer reviewers had data provided by Publons. A total of 396 M peer reviewers and a random sample of 1200 control group reviewers were included. A greater proportion of mega peer reviews were male (74%) as compared to the control reviewers (58% male). Mega peer reviewers demonstrated a significantly greater average number of total publications, citations, receipt of Publons awards, and a higher average h index as compared to the control group of reviewers (all p p > .428). Conclusions Mega peer reviewers registered in the Publons database also had a higher number of publications and citations as compared to a control group of reviewers. Additional research that considers motivations associated with peer review behaviour should be conducted to help inform peer reviewing activity.

Objective To understand the provider- and system-level factors affecting successful implementation of a virtual care intervention into type 1 diabetes (T1D) clinics. Methods Semi-structured interviews with managers and certified diabetes educators (CDEs) at diabetes clinics across Southern Ontario, prior to the COVID-19 pandemic. Deductive analysis using the Theoretical Domains Framework, then mapping to Behaviour Change Techniques to inform potential implementation strategies for high frequency virtual care for T1D. Results There was considerable intention to deliver high frequency virtual care to patients with T1D. Participants believed that this model of care could lead to improved patient outcomes and engagement, but would likely increase the workload of CDEs. Some felt there were insufficient resources at their site to enable them to participate in the program. Member-checking conducted during the pandemic revealed that clinics and staff had already developed strategies to overcome resource barriers to the adoption of virtual care during the pandemic. Conclusion Existing enablers for high frequency virtual care can be leveraged, and barriers can be overcome with targeted clinical incentives and support.

We established a patient centric navigation model embedded in primary care (PC) to support access to the broad range of health and social resources; the Access to Resources in the Community (ARC) model.We evaluated the feasibility of ARC using the rapid cycle evaluations of the intervention processes, patient and PC provider surveys, and navigator log data. PC providers enrolled were asked to refer patients in whom they identified a health and/or social need to the ARC navigator.Participants: 26 family physicians in four practices, and 82 of the 131 patients they referred. ARC was easily integrated in PC practices and was especially valued in the non-interprofessional practices. Patient overall satisfaction was very high (89%). Sixty patients completed the post-intervention surveys, and 33 reported accessing one or more service(s).The ARC Model is an innovative approach to reach and support a broad range of patients access needed resources. The Model is feasible and acceptable to PC providers and patients, and has demonstrated potential for improving patients' access to health and social resources. This study has informed a pragmatic randomized controlled trial to evaluate the ARC navigation to an existing web and telephone navigation service (Ontario 211).

Although there are effective evidence-based interventions (EBIs) to prevent, treat and coordinate care for chronic conditions they may not be adopted widely and when adopted, implementation challenges can limit their impact. Implementation strategies are “methods or techniques used to enhance the adoption, implementation, and sustainment of a clinical program or practice”. There is some evidence to suggest that to be more effective, strategies should be tailored; that is, selected and designed to address specific determinants which may influence implementation in a given context. Despite the growing popularity of tailoring the concept is ill-defined, and the way in which tailoring is applied can vary across studies or lack detail when reported. There has been less focus on the part of tailoring where stakeholders prioritise determinants and select strategies, and the way in which theory, evidence and stakeholders’ perspectives should be combined to make decisions during the process. Typically, tailoring is evaluated based on the effectiveness of the tailored strategy, we do not have a clear sense of the mechanisms through which tailoring works, or how to measure the “success” of the tailoring process. We lack an understanding of how stakeholders can be involved effectively in tailoring and the influence of different approaches on the outcome of tailoring. Our research programme, CUSTOMISE (Comparing and Understanding Tailoring Methods for Implementation Strategies in healthcare) will address some of these outstanding questions and generate evidence on the feasibility, acceptability, and efficiency of different tailoring approaches, and build capacity in implementation science in Ireland, developing and delivering training and supports for, and network of, researchers and implementation practitioners. The evidence generated across the studies conducted as part of CUSTOMISE will bring greater clarity, consistency, coherence, and transparency to tailoring, a key process in implementation science.

The state of open science needs to be monitored to track changes over time and identify areas to create interventions to drive improvements. In order to monitor open science practices, they first need to be well defined and operationalized. To reach consensus on what open science practices to monitor at biomedical research institutions, we conducted a modified 3-round Delphi study. Participants were research administrators, researchers, specialists in dedicated open science roles, and librarians. In rounds 1 and 2, participants completed an online survey evaluating a set of potential open science practices, and for round 3, we hosted two half-day virtual meetings to discuss and vote on items that had not reached consensus. Ultimately, participants reached consensus on 19 open science practices. This core set of open science practices will form the foundation for institutional dashboards and may also be of value for the development of policy, education, and interventions.

ObjectiveKey to reducing COVID-19 morbidity and mortality and reducing the need for further lockdown measures in Canada and worldwide is widespread acceptance of COVID-19 vaccines. Vaccine hesitancy has emerged as a key barrier to achieving optimal vaccination rates, for which there is little data among Canadians. This study examined rates of vaccine hesitancy and their correlates among Canadian adults.MethodsThis study analyzed data from five age, sex and province-weighted population-based samples to describe rates of hesitancy between April 2020 and March 2021 among Canadians who completed online surveys as part of the iCARE Study, and various sociodemographic, clinical and psychological correlates. Vaccine hesitancy was assessed by asking: “If a vaccine for COVID-19 were available today, what is the likelihood that you would get vaccinated?” Responses were dichotomized into ‘very likely’, ‘unlikely’, ‘somewhat unlikely’ (reflecting some degree of vaccine hesitancy) vs ‘extremely likely’ to get the vaccine, which was the comparator.ResultsOverall, 15,019 respondents participated in the study. A total of 42.2% of respondents reported vaccine hesitancy over the course of the study, which was lowest during surveys 1 (April 2020) and 5 (March 2021) and highest during survey 3 (November 2020). Fully adjusted multivariate logistic regression analyses revealed that women, those aged 50 and younger, non-Whites, those with high school education or less, and those with annual household incomes below the poverty line in Canada (i.e., $60,000) were significantly more likely to report being vaccine hesitant over the study period, as were essential and healthcare workers, parents of children under the age of 18, and those who do not get regular flu vaccines. Believing engaging in infection prevention behaviours (like vaccination) is important for reducing virus transmission and high COVID-19 health concerns (being infected and infecting others) were associated with 77% and 54% reduction in vaccine hesitancy, respectively, and having high personal financial concerns (worried about job or income loss) was associated with 1.33 times increased odds of vaccine hesitancy.ConclusionResults point to the importance of targeting vaccine efforts to women, younger people and socioeconomically disadvantaged groups, and that vaccine messaging should emphasize the benefits of getting vaccinated, and how the benefits (particularly to health) far outweigh the risks. Future research is needed to monitor ongoing changes in vaccine intentions and behaviour, as well as to better understand motivators and facilitators of vaccine acceptance, particularly among vulnerable groups.

Funding: NIHR Policy Research Program (project reference PR-R20-0318-22001). Aim To identify barriers and enablers of diabetic eye screening (DES) attendance amongst young adults with diabetes living in the UK. Methods Semi-structured 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, socio-cultural 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: [1] (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. Publisher PDF

Increasing deceased organ donation registration may increase the number of available organs for transplant to help save lives. This study aimed to identify which behaviour change techniques (BCTs; or 'active ingredients') are reported within randomized trials of interventions promoting deceased organ donation registration and of those, which are associated with a larger intervention effect.We conducted a secondary analysis of 45 trials included in a Cochrane systematic review of deceased organ donation registration interventions. Two researchers used the BCT Taxonomy v1 to independently code intervention content in all trial groups. Outcome data were pooled and we used meta-regression to explore associations between individual and combinations of recurring BCTs and effect on registration intention and/or registration behaviour.A total of 27 different BCTs (mean = 3.7, range = 1-9) were identified in intervention groups across the 45 trials. The five most common BCTs were: 'Information about health consequences' (71%); 'Instruction on how to perform the behaviour' (47%); 'Salience of consequences' (40%); 'Adding objects to the environment' (28%); and 'Credible source' (27%). Comparator groups in 20/45 trials also included identifiable BCTs (n = 12, mean = 3.1, range = 1-7). Meta-regression revealed that a combination of the three most common BCTs was associated with a larger intervention effect size for registration behaviour (k = 8, β = .19, p = .02).Trials of deceased organ donation registration interventions focus predominantly on providing information, instruction, and a means to register. While potentially effective, a much wider set of possible BCTs could be leveraged to address known barriers to registration.

IntroductionDiabetic retinopathy screening (DRS) attendance in young adults (YAs) is consistently below recommended levels. The aim of this study was to identify barriers and enablers of DRS attendance among YAs in the UK living with type 1 (T1D) and type 2 diabetes (T2D).Research design and methodsYAs (18–34 years) were invited to complete an anonymous online survey in June 2021 assessing agreement with 30 belief statements informed by the Theoretical Domains Framework (TDF) of behavior change describing potential barriers/enablers to DRS.ResultsIn total, 102 responses were received. Most had T1D (65.7%) and were regular attenders for DRS (76.5%). The most salient TDF domains for DRS attendance were ‘Goals’, with 93% agreeing that DRS was a high priority, and ‘Knowledge’, with 98% being aware that screening can detect eye problems early.Overall, 67.4% indicated that they would like greater appointment flexibility(Environmental context/resources) and 31.3% reported difficulties getting time off work/study to attend appointments(Environmental context/resources). This was more commonly reported by occasional non-attenders versus regular attenders (59.1% vs 23.4%, p=0.002). Most YAs were worried about diabetic retinopathy (74.3%), anxious when receiving screening results (63%) (Emotion) and would like more support after getting their results (66%) (Social influences). Responses for T1D and T2D were broadly similar, although those with T2D were more likely have developed strategies to help them to remember their appointments (63.6% vs 37.9%, p=0.019) (Behavioral regulation).ConclusionsAttendance for DRS in YAs is influenced by complex interacting behavioral factors. Identifying modifiable determinants of behavior will provide a basis for designing tailored interventions to improve DRS in YAs and prevent avoidable vision loss.

Diffuse implementation of hepatitis C virus (HCV) treatment is dependent on universal screening for HCV, but screening strategies are heterogenous across prisons in the province of Quebec (Canada). We sought to identify barriers and enablers to universal opt-out HCV screening and to describe the multisectoral decision-making processes related to HCV screening in Quebec provincial prisons.A multilevel, multi-theory informed qualitative descriptive approach was used to conduct semi-structured interviews. Interview guides and analyses with correctional stakeholders were informed by the Consolidated Framework for Implementation Research (CFIR) and those with healthcare professionals (HCPs) were based on the Theoretical Domains Framework (TDF). Directed content analysis was used to identify domains within CFIR and TDF reflecting barriers and enablers to opt-out HCV screening.Sixteen interviews (correctional stakeholders: n = 8; HCPs: n = 8) were conducted in April-May 2021. Twelve CFIR constructs were identified as barriers, seven as enablers, and two as neutral factors for the implementation of opt-out HCV screening. Correctional stakeholders underscored the need for political will (construct: external policy and incentives), highlighted limited resources (construct: available resources), and expressed concerns for the lack of consideration of implementation issues (constructs: trialability, planning). Six TDF domains were identified among HCPs as relevant to the implementation of opt-out HCV screening: beliefs about consequences (mixed = enablers and barriers), environmental context and resources (barrier), social influences (barrier), optimism (mixed), emotions (mixed), and behavioural regulation (barrier). The decision-making processes vis-à-vis HCV care in Quebec correctional settings were found to be hierarchical and complex.The use of CFIR and TDF was helpful in identifying barriers and enablers to HCV screening at multiple levels for people incarcerated in Quebec provincial prisons. Going forward, several political, structural, and organizational factors should be addressed through the engagement of stakeholders and people with lived experience of incarceration.