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.

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.

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.

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.

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 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.

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. Our objectives are: 1) to conduct a systematic review of the literature to identify factors affecting the relationship between hypothetical decisions and real-world behaviours, and 2) to summarise and organize these factors into a preliminary framework. METHODS: We conducted an electronic database search using PsycINFO and Medline on November 30th, 2015, updated March 7th, 2019. We also conducted a supplemental snowball search on December 9th 2015 and a reverse citation search using Scopus and Web of Science. Studies were eligible to be included in this review if they clearly addressed the consistency between some type of hypothetical decision and a corresponding real decision or behaviour. Two reviewers extracted data using a standardized data collection form developed through an iterative consensus-based process. We extracted basic study information and data about each study's research area, design, and research question. Quotations from the articles were extracted and summarized into standardized factor statements. RESULTS: Of the 2444 articles that were screened, 68 articles were included in the review. The articles identified 27 factors that we grouped into 4 categories: decision maker factors, cognitive factors, task factors, and matching factors. CONCLUSIONS: We have summarized a large number of factors that may be relevant when considering whether hypothetical health services pilot work can be expected to yield results that are consistent with real-world behaviours. Our descriptive framework can serve as the basis for organizing future work exploring which factors are most relevant when seeking to develop complex health services interventions.