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.

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.

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.

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.

Choosing which in-hospital laboratory tests to target for intervention: a scoping review.

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.

Supporting Trial Participation in People with the Huntington's Gene: A Patient-Centered, Theory-Guided Survey of Barriers and Enablers.

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.

Review of pragmatic trials found that multiple primary outcomes are common but so too are discrepancies between protocols and final reports.

OBJECTIVES: To describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials. STUDY DESIGN AND SETTING: Individually randomized trials labeled as pragmatic, published 2014-2019 in MEDLINE and registered with ClinicalTrials.gov. RESULTS: We identified 262 final reports and located protocols for 159 (61%); primary outcomes were clearly reported in 145 (91%) protocols and 256 (98%) final reports. Thirty (19%) protocols and 38 (15%) final reports had multiple primary outcomes. Primary outcomes were present and identical in 128 (81%) matched protocol-final reports. Among 140 pairs with target sample sizes reported, 28 (20.0%) reduced their target sample size (mean 543 fewer participants per trial) and 16 (11.4%) increased it (mean 192 more participants per trial). Thirteen (29.5%) provided an explanation. Only 2 of 30 (7%) protocols and 4 of 38 (11%) final reports with co-primary outcomes explained how results would be interpreted in light of multiplicity; 21 of 30 (70%) protocols and 20 of 38 (53%) final reports accounted for co-primary outcomes in power calculations. CONCLUSION: Co-primary outcomes are common in pragmatic trials; improved transparency around design and analysis decisions involving co-primary outcomes is required.

Informed consent in pragmatic trials: results from a survey of trials published 2014-2019.

OBJECTIVES: To describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent. METHODS: Survey of primary trial reports, published 2014-2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov. RESULTS: Among 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001). DISCUSSION: Not obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public's trust in research.

Informed consent in cluster randomised trials: a guide for the perplexed.

In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.

Patient Partner Perspectives Regarding Ethically and Clinically Important Aspects of Trial Design in Pragmatic Cluster Randomized Trials for Hemodialysis.

BACKGROUND: Cluster randomized trials (CRTs) are trials in which intact groups such as hemodialysis centers or shifts are randomized to treatment or control arms. Pragmatic CRTs have been promoted as a promising trial design for nephrology research yet may also pose ethical challenges. While randomization occurs at the cluster level, the intervention and data collection may vary in a CRT, challenging the identification of research participants. Moreover, when a waiver of patient consent is granted by a research ethics committee, there is an open question as to whether and to what degree patients should be notified about ongoing research or be provided with a debrief regarding the nature and results of the trial upon completion. While empirical and conceptual research exploring ethical issues in pragmatic CRTs has begun to emerge, there has been limited discussion with patients, families, or caregivers of patients undergoing hemodialysis. OBJECTIVE: To explore with patients and families with experience of hemodialysis research the challenges raised by different approaches to designing pragmatic CRTs in hemodialysis. Specifically, their perceptions of (1) the use of a waiver of consent, (2) notification processes and information provided to participants, and (3) any other concerns about cluster randomized designs in hemodialysis. DESIGN: Focus group and interview discussions of hypothetical clinical trial designs. SETTING: Focus groups and interviews were conducted in-person or via videoconference or telephone. PARTICIPANTS: Patient partners in hemodialysis research, defined as patients with personal experience of dialysis or a family member who had experience supporting a patient receiving hemodialysis, who have been actively involved in discussions to advise a research team on the design, conduct, or implementation of a hemodialysis trial. METHODS: Participants were invited to participate in focus groups or individual discussions that were audio recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts were analyzed using a thematic analysis approach. RESULTS: Two focus groups, three individual interviews, and one interview involving a patient and family member were conducted with 17 individuals between February 2019 and May 2020. Participants expressed support for approaches that emphasized patient choice. Disclosure of patient-relevant risks and information were key themes. Both consent and notification processes served to generate trust, but bypassing patient choice was perceived as undermining this trust. Participants did not dismiss the option of a waiver of consent. They were, however, more restrictive in their views about when a waiver of consent may be acceptable. Patient partners were skeptical of claims to impracticability based on costs or the time commitments for staff. LIMITATIONS: All participants were from Canada and had been involved in the design or conduct of a trial, limiting the degree to which results may be extrapolated. CONCLUSIONS: Given the preferences of participants to be afforded the opportunity to decide about trial participation, we argue that investigators should thoroughly investigate approaches that allow participants to make an informed choice regarding trial participation. In keeping with the preference for autonomous choice, there remains a need to further explore how consent approaches can be designed to facilitate clinical trial conduct while meeting their ethical requirements. Finally, further work is needed to define the limited circumstances in which waivers of consent are appropriate.

CONTEXTE: Les essais randomisés en grappes (CRT ­ Cluster Randomized Trials) sont des essais dans lesquels des groupes intacts, comme des centers ou horaires d'hémodialyse, sont répartis aléatoirement dans des groupes traités ou témoins. Les CRT pragmatiques ont été présentés comme un modèle prometteur pour la recherche en néphrologie, mais susceptible de poser des défis sur le plan éthique. Bien que la répartition aléatoire ait lieu au niveau du groupe, les interventions et la collecte de données peuvent varier dans un CRT, ce qui peut complexifier l'identification des participants. Aussi, lorsque le comité d'éthique de la recherche accorde une dérogation au consentement des patients, une question ouverte se pose quant à savoir si, et dans quelle mesure, les patients devraient être informés de la recherche en cours ou recevoir un compte rendu sur la nature et les résultats de l'étude une fois celle-ci terminée. Alors que des recherches empiriques et conceptuelles explorant les questions éthiques dans les CRT pragmatiques commencent à poindre, peu de discussions ont eu lieu avec les patients sous hémodialyse, leurs familles ou leurs soignants. OBJECTIFS: Explorer les défis posés par différentes approches de conception des CRT pragmatiques en contexte d'hémodialyse avec des patients ayant de l'expérience en recherche sur l'hémodialyse et leurs familles. Plus précisément : connaître leur avis sur a) l'utilization d'une renonciation au consentement; b) les processus de notification et les renseignements fournis aux participants; et c) toute autre préoccupation concernant les CRT en contexte d'hémodialyse. TYPE D'ÉTUDE: Entrevues et groupes de discussion sur la conception d'essais cliniques hypothétiques. CADRE: Les groupes de discussion et les entrevues ont eu lieu en personne, par vidéoconférence ou par téléphone. PARTICIPANTS: Les patients partenaires de recherche en hémodialyse ­ définis comme des patients ayant une expérience personnelle en dialyze ou un membre de leur famille avec de l'expérience dans l'accompagnement d'un patient en hémodialyse ­ qui ont participé activement à des discussions pour conseiller une équipe de recherche sur la conception, la conduite ou la mise en œuvre d'une étude en hémodialyse. MÉTHODOLOGIE: Les participants ont été invités à participer à des discussions individuelles et des groupes de discussion enregistrés avec leur consentement. Les enregistrements ont été transcrits intégralement avant l'analyze et les transcriptions ont été analysées en utilisant une approche d'analyze thématique. RÉSULTATS: Deux groupes de discussion, trois entrevues individuelles et une entrevue avec un patient et un membre de sa famille ont été menés auprès de 17 personnes entre février 2019 et mai 2020. Les participants ont exprimé leur appui aux approches qui privilégient le choix des patients. La divulgation des risques et des renseignements concernant le patient était un thème clé. Les processus de consentement et de notification ont tous deux généré de la confiance, mais le fait de contourner le choix du patient a été perçu comme une atteinte à celle-ci. Les participants n'ont pas écarté l'option d'une renonciation au consentement, mais ont été plus restrictifs quant au moment où celle-ci serait acceptable. Les patients partenaires se sont montrés sceptiques quant aux allégations d'impraticabilité fondées sur les coûts ou l'engagement en temps pour le personnel. LIMITES: Tous les participants étaient canadiens et avaient participé à la conception ou à la conduite d'un essai, ce qui limite le degré d'extrapolation des résultats. CONCLUSION: Puisque les participants préfèrent avoir le choix de participer à une étude, nous pensons que les chercheurs devraient étudier attentivement les approches qui permettent aux participants de faire un choix éclairé en cette matière. Conformément à la préférence pour un choix autonome, il demeure nécessaire d'explorer plus profondément la façon dont les approches de consentement peuvent être conçues pour faciliter la conduite des essais cliniques tout en respectant leurs exigences éthiques. D'autres travaux sont nécessaires pour définir les rares circonstances où une renonciation au consentement serait appropriée.

How well do critical care audit and feedback interventions adhere to best practice? Development and application of the REFLECT-52 evaluation tool.

BACKGROUND: Healthcare Audit and Feedback (A&F) interventions have been shown to be an effective means of changing healthcare professional behavior, but work is required to optimize them, as evidence suggests that A&F interventions are not improving over time. Recent published guidance has suggested an initial set of best practices that may help to increase intervention effectiveness, which focus on the "Nature of the desired action," "Nature of the data available for feedback," "Feedback display," and "Delivering the feedback intervention." We aimed to develop a generalizable evaluation tool that can be used to assess whether A&F interventions conform to these suggestions for best practice and conducted initial testing of the tool through application to a sample of critical care A&F interventions. METHODS: We used a consensus-based approach to develop an evaluation tool from published guidance and subsequently applied the tool to conduct a secondary analysis of A&F interventions. To start, the 15 suggestions for improved feedback interventions published by Brehaut et al. were deconstructed into rateable items. Items were developed through iterative consensus meetings among researchers. These items were then piloted on 12 A&F studies (two reviewers met for consensus each time after independently applying the tool to four A&F intervention studies). After each consensus meeting, items were modified to improve clarity and specificity, and to help increase the reliability between coders. We then assessed the conformity to best practices of 17 critical care A&F interventions, sourced from a systematic review of A&F interventions on provider ordering of laboratory tests and transfusions in the critical care setting. Data for each criteria item was extracted by one coder and confirmed by a second; results were then aggregated and presented graphically or in a table and described narratively. RESULTS: In total, 52 criteria items were developed (38 ratable items and 14 descriptive items). Eight studies targeted lab test ordering behaviors, and 10 studies targeted blood transfusion ordering. Items focused on specifying the "Nature of the Desired Action" were adhered to most commonly-feedback was often presented in the context of an external priority (13/17), showed or described a discrepancy in performance (14/17), and in all cases it was reasonable for the recipients to be responsible for the change in behavior (17/17). Items focused on the "Nature of the Data Available for Feedback" were adhered to less often-only some interventions provided individual (5/17) or patient-level data (5/17), and few included aspirational comparators (2/17), or justifications for specificity of feedback (4/17), choice of comparator (0/9) or the interval between reports (3/13). Items focused on the "Nature of the Feedback Display" were reported poorly-just under half of interventions reported providing feedback in more than one way (8/17) and interventions rarely included pilot-testing of the feedback (1/17 unclear) or presentation of a visual display and summary message in close proximity of each other (1/13). Items focused on "Delivering the Feedback Intervention" were also poorly reported-feedback rarely reported use of barrier/enabler assessments (0/17), involved target members in the development of the feedback (0/17), or involved explicit design to be received and discussed in a social context (3/17); however, most interventions clearly indicated who was providing the feedback (11/17), involved a facilitator (8/12) or involved engaging in self-assessment around the target behavior prior to receipt of feedback (12/17). CONCLUSIONS: Many of the theory-informed best practice items were not consistently applied in critical care and can suggest clear ways to improve interventions. Standardized reporting of detailed intervention descriptions and feedback templates may also help to further advance research in this field. The 52-item tool can serve as a basis for reliably assessing concordance with best practice guidance in existing A&F interventions trialed in other healthcare settings, and could be used to inform future A&F intervention development. TRIAL REGISTRATION: Not applicable.

Pilot and feasibility studies for pragmatic trials have unique considerations and areas of uncertainty.

BACKGROUND AND OBJECTIVE: Feasibility studies are increasingly being used to support the development of, and investigate uncertainties around, future large-scale trials. The future trial can be designed with either a pragmatic or explanatory mindset. Whereas pragmatic trials aim to inform the choice between different care options and thus, are designed to resemble conditions outside of a clinical trial environment, explanatory trials examine the benefit of a treatment under more controlled conditions. There is existing guidance for designing feasibility studies, but none that explicitly considers the goals of pragmatic designs. We aimed to identify unique areas of uncertainty that are relevant to planning a pragmatic trial. RESULTS: We identified ten relevant domains, partly based on the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) framework, and describe potential questions of uncertainty within each: intervention development, research ethics, participant identification and eligibility, recruitment of individuals, setting, organization, flexibility of delivery, flexibility of adherence, follow-up, and importance of primary outcome to patients and decision-makers. We present examples to illustrate how uncertainty in these domains might be addressed within a feasibility study. CONCLUSION: Researchers planning a feasibility study in advance of a pragmatic trial should consider feasibility objectives specifically relevant to areas of uncertainty for pragmatic trials.

Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them.

BACKGROUND: Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial. METHODS: We developed and conducted an online survey of breast cancer patients informed by the Theoretical Domains Framework and designed to determine previous experience with clinical trials, knowledge about clinical trials, and importance of a comprehensive list of barriers and enablers to trial participation. Participants were contacted by email or through social media. RESULTS: From 2451 subscribers of the CBCN, we received 244 responses and 210 completed surveys (244/2451 or 9.9% participation, 210/244 or 86.1% completion). A total of 38% of respondents indicated experience in trial participation, but 83% indicated confidence in their knowledge about clinical trials. Those who had previously participated in clinical trials were more confident in their knowledge (χ2= 6.77, p = 0.009) and answered more knowledge questions (t = -3.90 p = 0.000). Endorsed barriers and enablers to participation included 39 factors across 12 of 14 domains relevant to behaviour change. Our approach identifies barriers that might be meaningfully addressed by careful knowledge provision ('If I would learn more about my condition'; 'If I find the trial documents hard to understand'), those that may require other theory-informed approaches to address ('my feelings about the quality of my drug plan'; 'my worry over unknown side effects'), and those that may require tailored approaches depending on participant differences such as previous experience in trials ('If there were patient-friendly decision-making tools to help you make your participation decision'). DISCUSSION: This work demonstrates that a comprehensive, theory-guided survey of barriers and enablers to participation in breast cancer clinical trials is feasible, can lead to detailed knowledge about the issues related to participation in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation.

Top health research funders' guidance on selecting journals for funded research.

Background: Funded health research is being published in journals that many regard as "predatory", deceptive, and non-credible. We do not currently know whether funders provide guidance on how to select a journal in which to publish funded health research. Methods: We identified the largest 46 philanthropic, public, development assistance, public-private partnership, and multilateral funders of health research by expenditure, globally as well as four public funders from lower-middle income countries, from the list at https://healthresearchfunders.org. One of us identified guidance on disseminating funded research from each funders' website (August/September 2017), then extracted information about selecting journals, which was verified by another assessor. Discrepancies were resolved by discussion. Results were summarized descriptively. This research used publicly available information; we did not seek verification with funding bodies. Results: The majority (44/50) of sampled funders indicated funding health research. 38 (of 44, 86%) had publicly available information about disseminating funded research, typically called "policies" (29, 76%). Of these 38, 36 (95%) mentioned journal publication for dissemination of which 13 (36.11%) offer variable guidance on selecting a journal, all of which relate to the funder's open access mandate. Six funders (17%) outlined publisher requirements or features by which to select a journal. One funder linked to a document providing features of journals to look for (e.g. listed in the Directory of Open Access Journals) and to be wary of (e.g., no journal scope statement, uses direct and unsolicited marketing). Conclusions: Few funders provided guidance on how to select a journal in which to publish funded research. Funders have a duty to ensure that the research they fund is discoverable by others. This research is a benchmark for funder guidance on journal selection prior to the January 2021 implementation of Plan S (a global, funder-led initiative to ensure immediate, open access to funded, published research).

Barriers and enablers to effective interprofessional teamwork in the operating room: A qualitative study using the Theoretical Domains Framework.

BACKGROUND: Effective teamwork is critical for safe, high-quality care in the operating room (OR); however, teamwork interventions have not consistently resulted in the expected gains for patient safety or surgical culture. In order to optimize OR teamwork in a targeted and evidence-based manner, it is first necessary to conduct a comprehensive, theory-informed assessment of barriers and enablers from an interprofessional perspective. METHODS: This qualitative study was informed by the Theoretical Domains Framework (TDF). Volunteer, purposive and snowball sampling were conducted primarily across four sites in Ontario, Canada and continued until saturation was reached. Interviews were recorded, transcribed, and de-identified. Directed content analysis was conducted in duplicate using the TDF as the initial coding framework. Codes were then refined whereby similar codes were grouped into larger categories of meaning within each TDF domain, resulting in a list of domain-specific barriers and enablers. RESULTS: A total of 66 OR healthcare professionals participated in the study (19 Registered Nurses, two Registered Practical Nurses, 17 anaesthesiologists, 26 surgeons, two perfusionists). The most frequently identified teamwork enablers included people management, shared definition of teamwork, communication strategies, positive emotions, familiarity with team members, and alignment of teamwork with professional role. The most frequently identified teamwork barriers included others' personalities, gender, hierarchies, resource issues, lack of knowledge of best practices for teamwork, negative emotions, conflicting norms and perceptions across professions, being unfamiliar with team members, and on-call/night shifts. CONCLUSIONS: We identified key factors influencing OR teamwork from an interprofessional perspective using a theoretically informed and systematic approach. Our findings reveal important targets for future interventions and may ultimately increase their effectiveness. Specifically, achieving optimal teamwork in the OR may require a multi-level intervention that addresses individual, team and systems-level factors with particular attention to complex social and professional hierarchies.

Using behavioral theory and shared decision-making to understand clinical trial recruitment: interviews with trial recruiters.

BACKGROUND: Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behavior change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential theoretical frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF) in order to explore the utility of these frameworks in trial recruitment. METHODS: We interviewed all nine active study recruiters from a multi-site, open-label pilot trial assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or master's-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of their recruitment activities, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement and informed the thematic analysis. RESULTS: The analysis helped to identify 28 sub-themes across 11 domains. The sub-themes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed. CONCLUSIONS: Identified sub-themes can be linked to TDF domains for which effective behavior change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision-making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.

A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing.

OBJECTIVE: We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment. STUDY DESIGN AND SETTING: Trials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text. RESULTS: 4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term "pragmatic" was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%. CONCLUSION: There is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses.

Informing the research agenda for optimizing audit and feedback interventions: results of a prioritization exercise.

BACKGROUND: Audit and feedback (A&F) interventions are one of the most common approaches for implementing evidence-based practices. A key barrier to more effective A&F interventions is the lack of a theory-guided approach to the accumulation of evidence. Recent interviews with theory experts identified 313 theory-informed hypotheses, spread across 30 themes, about how to create more effective A&F interventions. In the current survey, we sought to elicit from stakeholders which hypotheses were most likely to advance the field if studied further. METHODS: From the list of 313, three members of the research team identified 216 that were clear and distinguishable enough for prioritization. A web-based survey was then sent to 211 A&F intervention stakeholders asking them to choose up to 50 'priority' hypotheses following the header "A&F interventions will be more effective if…". Analyses included frequencies of endorsement of the individual hypotheses and themes into which they were grouped. RESULTS: 68 of the 211 invited participants responded to the survey. Seven hypotheses were chosen by > 50% of respondents, including A&F interventions will be more effective… "if feedback is provided by a trusted source"; "if recipients are involved in the design/development of the feedback intervention"; "if recommendations related to the feedback are based on good quality evidence"; "if the behaviour is under the control of the recipient"; "if it addresses barriers and facilitators (drivers) to behaviour change"; "if it suggests clear action plans"; and "if target/goal/optimal rates are clear and explicit". The most endorsed theme was Recipient Priorities (four hypotheses were chosen 92 times as a 'priority' hypotheses). CONCLUSIONS: This work determined a set of hypotheses thought by respondents to be to be most likely to advance the field through future A&F intervention research. This work can inform a coordinated research agenda that may more efficiently lead to more effective A&F interventions.

A patient-focused, theory-guided approach to survey design identified barriers to and drivers of clinical trial participation.

OBJECTIVES: Despite clear evidence showing that many clinical trials fail or are delayed because of poor patient recruitment, there is surprisingly little empirically supported guidance for trialists seeking to optimize their trial recruitment strategies. We propose that the challenges of recruitment can be better understood and addressed by thinking of research participation as one or more behaviors, subject to the same forces as other human behaviors. In this article, we describe an adaptable, behavioral theory-driven approach for designing pretrial surveys of the barriers and drivers relevant to trial participation. Instead of proposing a single survey instrument intended to be used uniformly across many situations, we propose that tailored surveys be informed by a common comprehensive, theory-guided development approach that ensures all domains potentially guiding participation are considered. STUDY DESIGN AND SETTING: We used the Theoretical Domains Framework (TDF), which organizes over 100 constructs known to be associated with behavior and behavior change into 14 domains that describe determinants of professional and patient health behaviors, to inform the development of tailored surveys about barriers to and drivers of clinical trial participation. After searching the literature for barriers and drivers to trial recruitment relevant to each of the TDF domains, we developed separate surveys for members of two national health charities (Canadian Breast Cancer Network, Huntington Society of Canada) to exemplify how the approach can be adapted across settings. We conducted think-aloud interviews with members of each group to maximize the clarity and usability of the surveys, elicited opinions about which barriers/drivers were relevant for each patient group, and identified additional barriers/drivers. Interviews proceeded iteratively with changes incorporated into subsequent interviews. Here, we describe our two target patient groups, as well as our process of modifying, adding, and deleting barrier/driver items for each group and across theoretical domains. RESULTS: We interviewed 8 women with a history of breast cancer from the Canadian Breast Cancer Network (48-65 year old) and 11 Huntington Disease community members (9 women) from the Huntington Society of Canada (26-70 year old). After the iterative development interviews, the breast cancer group had identified 38 barriers/drivers thought relevant to their participation in clinical trials across 12 TDF domains. The Huntington group identified 47 items across 13 TDF domains. CONCLUSION: Our patient-focused and theory-guided approach was able to identify a more comprehensive range of barriers to and drivers of trial participation than existing published tools. Our approach is also more broadly adaptable than such tools, in that it uses a theoretical framework and in-depth piloting to generate a set of items tailored to each specific clinical area, rather than a single set of items intended to be applicable to all situations. This theory-guided approach also enables more specific recruitment strategies to be developed once domain-specific barriers are known, potentially optimizing participation for a given trial and helping build a cumulative evidence of barriers/drivers and strategies for addressing them.