Use of Implementation Science Concepts in the Study of Misinformation: A Scoping Review.

Misinformation hinders the impact of public health initiatives. Efforts to counter misinformation likely do not consider the full range of factors known to affect how individuals make decisions and act on them. Implementation science tools and concepts can facilitate the development of more effective interventions against health misinformation by leveraging advances in behavior specification, uptake of evidence, and theory-guided development and evaluation of complex interventions.

: Implementation and Evaluation of A Novel Extubation Clinical Decision Support Tool.

Importance: Extubation Advisor (EA) is a novel software tool that generates a synoptic report for each Spontaneous Breathing Trial (SBT) conducted to inform extubation decision-making.

Objectives: To assess bedside EA implementation, perceptions of utility, and identify barriers and facilitators of use.

Design, Setting And Participants: We conducted a phase I mixed-methods interventional study in three mixed intensive care unit (ICUs) in two academic hospitals.

How do experts determine where to intervene on test ordering? An interview study.

Objectives: Lab testing is a high-volume activity that is often overused, leading to wasted resources and inappropriate care. Improving test ordering practices in tertiary care involves deciding where to focus scarce intervention resources, but clear guidance on how to optimize these resources is lacking. We aimed to explore context-sensitive factors and processes that inform individual decisions about laboratory stewardship interventions by speaking to key interest holders in this area.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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. 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.

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).

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.

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.

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.

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.

Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials.

Background: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent.

When piloting health services interventions, what predicts real world behaviours? A systematic concept mapping review.

Background: Modeling studies to inform the design of complex health services interventions often involves elements that differ from the intervention's ultimate real-world use. These "hypothetical" elements include pilot participants, materials, and settings. Understanding the conditions under which studies with "hypothetical" elements can yield valid results would greatly help advance health services research.