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.

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

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

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.

Multi-phase implementation of automated external defibrillator use by nurses during in-hospital cardiac arrest and its impact on survival.

OBJECTIVE: We sought to evaluate the impact of a medical directive allowing nurses to use defibrillators in automated external defibrillator-mode (AED) on in-hospital cardiac arrest (IHCA) outcomes. METHODS: We completed a health record review of consecutive IHCA for which resuscitation was attempted using a pragmatic multi-phase before-after cohort design. We report Utstein outcomes before (Jan.2012-Aug.2013;Control) the implementation of the AED medical directive following usual practice (Sept.2013-Aug.2016;Phase 1), and following the addition of a theory-based educational video (Sept.2016-Dec.2017;Phase 2). RESULTS: There were 753 IHCA with the following characteristics (Before n = 195; Phase 1n = 372; Phase 2n = 186): mean age 66, 60.0% male, 79.3% witnessed, 29.1% noncardiac-monitored medical ward, 23.9% cardiac cause, and initial ventricular fibrillation/tachycardia (VF/VT) 27.2%. Comparing the Before, Phase 1 and 2: an AED was used 0 time (0.0%), 21 times (5.7%), 15 times (8.1%); mean times to 1st analysis were 7 min, 3 min and 1 min (p < 0.0001); mean times to 1st shock were 12 min, 10 min and 8 min (p = 0.32); return of spontaneous circulation (ROSC) was 63.6%, 59.4% and 58.1% (p = 0.77); survival was 24.6%, 21.0% and 25.8% (p = 0.37). Among IHCA in VF/VT (n = 165), time to 1st analysis and 1st shock decreased by 5 min (p = 0.01) and 6 min (p = 0.23), and ROSC and survival increased by 3.0% (p = 0.80) and 15.6% (p = 0.31). There was no survival benefit overall (1.2%; p = 0.37) or within noncardiac-monitored areas (-7.2%; p = 0.24). CONCLUSIONS: The implementation of a medical directive allowing for AED use by nurses successfully improved key outcomes for IHCA victims, particularly following the theory-based education video and among the VF/VT group.

Implementation of a 1-Day Living Kidney Donor Evaluation Program: A Qualitative Analysis of Donor Candidate and Stakeholder Perspectives.

Introduction: A lengthy donor evaluation process hinders living donor kidney transplantation (LDKT). At The Ottawa Hospital, 1-day evaluation process was recently developed, with a goal to accelerate the determination of donor suitability. The major objective of this study was to solicit feedback from donor candidates and key stakeholders who participated in the 1-day living kidney donor evaluation process, to determine the program's acceptability and factors influencing its implementation elsewhere. Methods: Semi-structured interviews were conducted with donor candidates who participated in the 1-day living kidney donor evaluation process, and with stakeholders who are instrumental to the implementation strategy. Interviews were conducted via videoconference or by telephone from May 2022 to December 2022. Directed content analysis was conducted using 2 unique frameworks for stakeholder and donor candidate interviews. Results: Our study included 13 stakeholders and 18 donor candidates, of whom 16 (89%) were women and 7 (39%) proceeded to kidney donation. Eighteen (100%) perceived the process to be both time-effective and cost-effective, due to reduced travel and missed work time. Thirteen (72%) felt that the 1-day evaluation may accelerate determination of donor suitability. Sequential virtual sessions with a nurse and social worker in advance of the evaluation day were seen as providing critical education and support. Among stakeholders, 11 (85%) emphasized donor candidate care and faster candidacy determinations. Conclusion: The 1-day evaluation process was preferred by most donor candidates, and was perceived as time-effective and cost-effective by most interviewees. An expedited, 1-day evaluation may accelerate determination of donor suitability and improve LDKT rates.

Advance Consent in Acute Stroke Trials: Survey of Canadian Stroke Physicians.

Advance consent presents a potential solution to the challenge of obtaining informed consent for participation in acute stroke trials. Clinicians in stroke prevention clinics are uniquely positioned to identify and seek consent from potential stroke trial participants. To assess the acceptability of advance consent to Canadian stroke clinic physicians, we performed an online survey. We obtained 58 respondents (response rate 35%): the vast majority (82%) expressed comfort with obtaining advance consent and 92% felt that doing so would not be a significant disruption to clinic workflow. These results support further study of advance consent for acute stroke trials.

Response to Merz.

Jon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response, we defend our article against these objections. We argue that Merz's critique rests on a misunderstanding of our article, defend the daily life standard as a guardrail for leveraging cognitive biases, and argue that rejecting all behavioral influences is not a helpful nor a sustainable answer to their increasing use in trial recruitment.

Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials.

BACKGROUND: There are few data on patient and public involvement (PPI) in pragmatic trials. We aimed to describe the prevalence and nature of PPI within pragmatic trials, describe variation in prevalence of PPI by trial characteristics and compare prevalence of PPI reported by trial authors to that reported in trial publications. METHODS: We applied a search filter to identify pragmatic trials published from 2014 to 2019 in MEDLINE. We invited the corresponding authors of pragmatic trials to participate in an online survey about their specific trial. RESULTS: Of 3163 authors invited, 2585 invitations were delivered, 710 (27.5%) reported on 710 unique trials and completed the survey; 334 (47.0%) conducted PPI. Among those who conducted PPI, for many the aim was to increase the research relevance (86.3%) or quality (76.5%). Most PPI partners were engaged at protocol development stages (79.1%) and contributed to the co-design of interventions (70.9%) or recruitment or retention strategies (60.5%). Patient and public involvement was more common among trials involving children, trials conducted in the United Kingdom, cluster randomized trials, those explicitly labelled as "pragmatic" in the study manuscript, and more recent trials. Less than one-quarter of trials (22.8%) that reported PPI in the survey also reported PPI in the trial manuscript. INTERPRETATION: Nearly half of trialists in this survey reported conducting PPI and listed several benefits of doing so, but researchers who did not conduct PPI often cited a lack of requirement for it. Patient and public involvement appears to be significantly underreported in trial publications. Consistent and standardized reporting is needed to promote transparency about PPI methods, outcomes, challenges and benefits.

Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial.

BACKGROUND: We developed the Canadian Syncope Pathway (CSP) based on the Canadian Syncope Risk Score (CSRS) to aid emergency department (ED) syncope management. This pilot implementation study assessed patient inclusion, length of transition period, as well as process measures (engagement, reach, adoption, and fidelity) to prepare for multicenter implementation. METHODS: A non-randomized stepped wedge trial at two hospitals was conducted over a 7-month period. After 2-3 months in the control condition, the hospitals crossed over in a stepwise fashion to the intervention condition. Study participants were ED and non-ED physicians, or their delegates, and patients (aged ≥ 18 years) with syncope. We aimed to analyze patient characteristics, ED management including disposition decision, and CSRS recommendations application for all eligible patients during the intervention period. Our targets were 95% inclusion rate, 70% adoption (proportion of physicians who applied the pathway), 60% reach (intervention applied to eligible patients) and 70% fidelity (appropriate recommendations application) for all eligible patients. Clinical Trials registration NCT04790058. RESULTS: 1002 eligible patients (mean age 56.6 years; 51.0% males) were included: 349 patients during the control and 653 patients during the intervention period. Physician engagement varied from 39.7% to 97.1% for presentation at meetings. Process measures for the first month and the end of the intervention were: adoption 70.7% (58/82) and 84.4% (103/122), reach 67.5% (108/160) and 55.0% (359/653), fidelity among patients with physician data form completion 86.3% (88/102) and 88.3% (294/333), versus fidelity among all eligible patients 83.8% (134/160) and 83.3% (544/653) respectively with no significant differences in fidelity at one month and the end of the intervention period. CONCLUSION: In this pilot study, we achieved all prespecified benchmarks for proceeding to the multicenter CSP implementation except reach. Our results indicate a 1-month transition period will be adequate though regular reminders will be needed during full-scale implementation.

RéSUMé: CONTEXTE: Nous avons mis au point la Canadian Syncope Pathway (CSP) basée sur le Canadian Syncope Risk Score (CSRS) pour aider les services d'urgence à gérer la syncope. Cette étude pilote de mise en œuvre a évalué l'inclusion des patients, la durée de la période de transition, ainsi que les mesures de processus (engagement, portée, adoption et fidélité) pour se préparer à la mise en œuvre multicentrique MéTHODES: Un essai par étapes non randomisé dans deux hôpitaux a été mené sur une période de 7 mois. Après 2 à 3 mois dans l'état de contrôle, les hôpitaux sont passés progressivement à l'état d'intervention. Les participants à l'étude étaient des médecins du service de l'urgence et non du service de l'urgence, ou leurs délégués, et des patients (âgés de 18 ans) atteints de syncope. Nous avons cherché à analyser les caractéristiques des patients, la prise en charge des urgences, y compris la décision de disposition, et l'application des recommandations du CSRS pour tous les patients admissibles pendant la période d'intervention. Nos cibles étaient le taux d'inclusion de 95 %, l'adoption de 70 % (proportion de médecins qui ont appliqué la voie), la portée de 60 % (intervention appliquée aux patients admissibles) et la fidélité de 70 % (application des recommandations appropriées) pour tous les patients admissibles. Enregistrement des essais cliniques NCT04790058. RéSULTATS: 1002 patients éligibles (âge moyen 56,6 ans; 51,0% d'hommes) ont été inclus : 349 patients pendant le contrôle et 653 patients pendant la période d'intervention. La participation des médecins variait de 39,7 % à 97,1 % pour la présentation aux réunions. Les mesures du processus pour le premier mois et la fin de l'intervention étaient les suivantes : adoption 70,7 % (58/82) et 84,4 % (103/122), atteinte de 67,5 % (108/160) et 55,0 % (359/653), fidélité chez les patients ayant rempli le formulaire de données médicales 86,3 % (88/102) et 88,3 % (294/333), versus fidélité chez tous les patients admissibles 83,8 % (134/160) et 83,3 % (544/653) respectivement, sans différence significative de fidélité à un mois et à la fin de la période d'intervention. CONCLUSION: Dans cette étude pilote, nous avons atteint tous les points de repère prédéterminés pour procéder à la mise en œuvre du PSC multicentrique, sauf la portée. Nos résultats indiquent qu'une période de transition d'un mois sera adéquate, bien que des rappels réguliers seront nécessaires pendant la mise en œuvre à grande échelle.

Potential social marketing applications for knowledge translation in healthcare: a scoping review protocol.

INTRODUCTION: Knowledge translation has emerged as a practice and a science to bridge the gap between evidence and practice in healthcare. While the field has appropriately borrowed from other related fields to advance its science, there remain fields less mined. One such field with potential relevance to knowledge translation, but limited application to date, is social marketing. This review aims to determine elements of social marketing interventions that could be applied to knowledge translation science. Our objectives are to: (1) summarise the types of studies that have tested social marketing interventions in controlled intervention study designs; (2) describe the social marketing interventions and their effects; and (3) propose strategies for the integration of social marketing interventions into knowledge translation science. METHODS AND ANALYSIS: This scoping review will be conducted using the Joanna Briggs Institute Methodological Guidance. For the first and second objectives, all English-language studies published from 1971 onwards will be included if they (1) used a randomised or non-randomised controlled intervention design, and (2) tested a social marketing intervention as defined by five essential social marketing criteria. The research team will address the third objective through discussion and consensus. All screening and extraction will be performed independently by two reviewers. Variables extracted will include intervention details using essential and desirable social marketing criteria and the context, mechanism and outcomes of the interventions. ETHICS AND DISSEMINATION: This project is a secondary analysis of published papers and does not require ethics approval. We will disseminate our review outputs in knowledge translation journals and present at relevant conferences across the spectrum of the field. We will produce a short and long version of a plain language summary that will be tailored to various groups including implementation scientists and quality improvement researchers. REGISTRATION DETAILS: Open Science Framework Registration link: osf.io/6q834.

Advance Consent in Acute Stroke Trials: Survey of Canadian Research Ethics Board Chairs.

Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.

Best practice guidance for antibiotic audit and feedback interventions in primary care: a modified Delphi study from the Joint Programming Initiative on Antimicrobial resistance: Primary Care Antibiotic Audit and Feedback Network (JPIAMR-PAAN).

BACKGROUND: Primary care is a critical partner for antimicrobial stewardship efforts given its high human antibiotic usage. Peer comparison audit and feedback (A&F) is often used to reduce inappropriate antibiotic prescribing. The design and implementation of A&F may impact its effectiveness. There are no best practice guidelines for peer comparison A&F in antibiotic prescribing in primary care. OBJECTIVE: To develop best practice guidelines for peer comparison A&F for antibiotic prescribing in primary care in high income countries by leveraging international expertise via the Joint Programming Initiative on Antimicrobial Resistance-Primary Care Antibiotic Audit and Feedback Network. METHODS: We used a modified Delphi process to achieve convergence of expert opinions on best practice statements for peer comparison A&F based on existing evidence and theory. Three rounds were performed, each with online surveys and virtual meetings to enable discussion and rating of each best practice statement. A five-point Likert scale was used to rate consensus with a median threshold score of 4 to indicate a consensus statement. RESULTS: The final set of guidelines include 13 best practice statements in four categories: general considerations (n = 3), selecting feedback recipients (n = 1), data and indicator selection (n = 4), and feedback delivery (n = 5). CONCLUSION: We report an expert-derived best practice recommendations for designing and evaluating peer comparison A&F for antibiotic prescribing in primary care. These 13 statements can be used by A&F designers to optimize the impact of their quality improvement interventions, and improve antibiotic prescribing in primary care.

Development of practice recommendations based on the Canadian Syncope Risk Score and identification of barriers and facilitators for implementation.

BACKGROUND: Wide variations in emergency department (ED) syncope management exist. The Canadian Syncope Risk Score (CSRS) was developed to predict the probability of 30-day serious outcomes after ED disposition. Study objectives were to evaluate the acceptability of proposed CSRS practice recommendations among providers and patients, and identify barriers and facilitators for CSRS use to guide disposition decisions. METHODS: We conducted semi-structured interviews with 41 physicians involved in ED syncope and 35 ED patients with syncope. We used purposive sampling to ensure a variety of physician specialties and CSRS patient risk levels. Thematic analysis was completed by two independent coders with consensus meetings to resolve conflicts. Analysis proceeded in parallel with interviews until data saturation. RESULTS: The majority (97.6%; 40/41) of physicians agreed with discharge of low risk (CSRS ≤ 0) but opined that 'no follow up' changed to 'follow-up as needed'. Physicians indicated current practices do not align with the medium-risk recommendation to discharge patients with 15-day monitoring (CSRS = 1-3; due to lack of access to monitors and timely follow-up) and the high-risk recommendation (CSRS ≥ 4) to potentially discharge patients with 15-day monitoring. Physicians recommended brief hospitalization of high-risk patients due to patient safety concerns. Facilitators included the CSRS-based patient education and scores supporting their clinical gestalt. Patients reported receiving varying levels of information regarding syncope and post-ED care, were satisfied with care received and preferred less resource intensive options. CONCLUSION: Our recommendations based on the study results were: discharge of low-risk patients with physician follow-up as needed; discharge of medium-risk patients with 15-day cardiac monitoring and brief hospitalization of high-risk patients with 15-day cardiac monitoring if discharged. Patients preferred less resource intensive options, in line with CSRS recommended care. Implementation should leverage identified facilitators (e.g., patient education) and address the barriers (e.g., monitor access) to improve ED syncope care.

RéSUMé: CONTEXTE: La prise en charge des syncopes par les services d'urgence varie considérablement. Le Canadian Syncope Risk Score (CSRS) a été mis au point pour prédire la probabilité d'une issue grave à 30 jours après la prise en charge par le service des urgences. Les objectifs de l'étude étaient d'évaluer l'acceptabilité des recommandations pratiques proposées par le CSRS parmi les prestataires et les patients, et d'identifier les barrières et les facilitateurs de l'utilisation du CSRS pour guider les décisions de disposition. MéTHODES: Nous avons mené des entretiens semi-structurés avec 41 médecins impliqués dans la syncope aux urgences et 35 patients souffrant de syncope aux urgences. Nous avons utilisé un échantillonnage raisonné pour assurer une variété de spécialités médicales et de niveaux de risque pour les patients du CSRS. L'analyse thématique a été réalisée par deux codeurs indépendants, avec des réunions de consensus pour résoudre les conflits. L'analyse s'est déroulée parallèlement aux entretiens jusqu'à saturation des données. RéSULTATS: La majorité (97,6 % ; 40/41) des médecins étaient d'accord avec la sortie des patients à faible risque (CSRS ≤ 0), mais ont estimé que " pas de suivi " devait être remplacée par " suivi en fonction des besoins ". Les médecins ont indiqué que leurs pratiques actuelles ne sont pas conformes à la recommandation à risque moyen de faire sortir les patients avec une surveillance de 15 jours (CSRS = 1-3 ; en raison du manque d'accès aux moniteurs et au suivi en temps opportun) et à la recommandation à risque élevé (CSRS ≥ 4) de potentiellement faire sortir les patients avec une surveillance de 15 jours. Les médecins ont recommandé une brève hospitalisation des patients à haut risque pour des raisons de sécurité. Les facilitateurs comprenaient l'éducation des patients basée sur le CSRS et les scores soutenant leur gestalt clinique. Les patients ont déclaré avoir reçu différents niveaux d'information concernant la syncope et les soins post-urgence, étaient satisfaits des soins reçus et préféraient des options moins gourmandes en ressources. CONCLUSIONS: Nos recommandations basées sur les résultats de l'étude sont les suivantes : sortie des patients à faible risque avec suivi par un médecin si nécessaire ; la sortie des patients à risque moyen avec une surveillance cardiaque de 15 jours et une brève hospitalisation des patients à risque élevé avec une surveillance cardiaque de 15 jours en cas de sortie. Les patients ont préféré des options moins gourmandes en ressources, conformément aux soins recommandés par le CSRS. La mise en œuvre devrait s'appuyer sur les facilitateurs identifiés (par exemple, l'éducation des patients) et s'attaquer aux obstacles (par exemple, le contrôle de l'accès) pour améliorer les soins aux urgences en cas de syncope.

Reducing touching eyes, nose and mouth ('T-zone') to reduce the spread of infectious disease: A prospective study of motivational, volitional and non-reflective predictors.

BACKGROUND: The route into the body for many pathogens is through the eyes, nose and mouth (i.e., the 'T-zone') via inhalation or fomite-based transfer during face touching. It is important to understand factors that are associated with touching the T-zone to inform preventive strategies. PURPOSE: To identify theory-informed predictors of intention to reduce facial 'T-zone' touching and self-reported 'T-zone' touching. METHODS: We conducted a nationally representative prospective questionnaire study of Canadians. Respondents were randomized to answer questions about touching their eyes, nose, or mouth with a questionnaire assessing 11 factors from an augmented Health Action Process Approach at baseline: intention, outcome expectancies, risk perception, individual severity, self-efficacy, action planning, coping planning, social support, automaticity, goal facilitation and stability of context. At 2-week follow-up, we assessed HAPA-based indicators of self-regulatory activities (awareness of standards, effort, self-monitoring) and self-reported behaviour (primary dependent variable). RESULTS: Of 656 Canadian adults recruited, 569 responded to follow-up (87% response rate). Across all areas of the 'T-zone', outcome expectancy was the strongest predictor of intention to reduce facial 'T-zone' touching, while self-efficacy was a significant predictor for only the eyes and mouth. Automaticity was the strongest predictor of behaviour at the 2-week follow-up. No sociodemographic or psychological factors predicted behaviour, with the exception of self-efficacy, which negatively predicted eye touching. CONCLUSION: Findings suggest that focusing on reflective processes may increase intention to reduce 'T-zone' touching, while reducing actual 'T-zone' touching may require strategies that address the automatic nature of this behaviour.

Changing patient preferences toward better trial recruitment: an ethical analysis.

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.

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

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

Community consensus on core open science practices to monitor in biomedicine.

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.

Identifying barriers and enablers to rigorous conduct and reporting of preclinical laboratory studies.

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.