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.

Caring for the Caregiver (C4C): An Integrated Stepped Care Model for Caregivers of Children With Medical Complexity.

Children with medical complexity (CMC) are a medically fragile subset of children who rely on parental caregivers for substantial care needs. Caregivers of CMC often experience adverse health outcomes such as depression and anxiety, sleep deprivation, financial hardships, and social isolation. Caregivers of CMC are at risk of premature mortality, which is thought to be mediated by chronic and elevated stress, as well as psychiatric morbidity risk. Access to mental health care, where the needs of both the caregiver and child are considered, can enable caregivers to meet high caregiving demands and improve both child and caregiver outcomes. We describe the Caring for the Caregiver (C4C) model, a novel integrated stepped care model consisting of collaboration between a psychiatrist and a pediatric complex care program. This model provides support in 3 steps: 1) early identification of distress, 2) social work assessment, intervention and psychotherapy, and 3) psychiatric care, including diagnosis or medication initiation, for caregivers of CMC. This innovative model will be the first to embed support for the mental health needs of caregivers of CMC within a pediatric team, facilitating access to psychiatric care and serving as a foundation for future integrated stepped care models.

Clinician perspectives on the implementation of inpatient cycling-based exergames for children with cerebral palsy: A qualitative study.

OBJECTIVE: To understand the perspectives of key stakeholder clinicians in implementing inpatient cycling-based exergames for children with cerebral palsy (CP) into pediatric rehabilitation. METHODS: Sixteen clinicians (nurses, physiotherapists, recreational therapists) that participated in a study exploring the feasibility of implementing cycling-based exergames for inpatient children with CP were interviewed. Clinicians' responses were coded using the Theoretical Domains Framework (TDF). Beliefs were generated from each response and relevant domains were identified. RESULTS: Ten domains from the TDF were identified as relevant. Key enablers to clinician participation in future implementation included revision of clinician roles and responsibilities, the belief that children with CP will benefit from exergames, and the belief in potential applicability to other pediatric populations. Barriers included clinician limited time and exergame responsibilities not aligning with perceived clinician roles. CONCLUSIONS: This study identifies key barriers and enablers that future inpatient pediatric rehabilitation settings should consider when incorporating exergames into rehabilitation practice.

Understanding potential barriers and enablers to a perioperative early phase cell therapy trial.

BACKGROUND AIMS: Early-phase cell therapy clinical trials depend on patient and physician involvement, yet barriers can impede their participation. METHODS: To optimize engagement for a planned cell therapy trial to prevent perioperative cardiac complications, the authors conducted semi-structured interviews with at-risk patients and physicians who could potentially be involved in the study. The authors used the theoretical domains framework to systematically identify potential barriers and enablers. RESULTS: Forty-one interviews were conducted to reach data saturation, and four overall potential barriers to participation (themes) were identified. Theme 1 emphasizes that patients and physicians need accessible information to better understand the benefits and risks of the novel therapy and trial procedures and to address misconceptions. Theme 2 underscores the need for clarity on whether the trial's primary purpose is safety or efficacy, as this may influence patient and physician decisions. Theme 3 recognizes the resource and logistic realities for patients (e.g., convenient follow-up appointments) and physicians (e.g., personnel to assist in trial procedures, competing priorities). Theme 4 describes the importance of social influences (e.g., physicians and family, peers/colleagues) that may affect decisions to participate and the importance of patient preferences (e.g., availability of physicians to discuss the trial, including caregivers in discussions). CONCLUSIONS: Prospectively addressing these issues may help optimize feasibility prior to conducting an expensive, resource-intensive trial.

Inpatient Exergames for Children with Cerebral Palsy following Lower Extremity Orthopedic Surgery: A Feasibility Study.

Objective: Evaluate the feasibility of implementing cycling-based exergames for children with cerebral palsy (CP) following lower extremity orthopedic surgery and explore its impact on pain and well-being.Methods: Ten children with CP were recruited; the first five received physiotherapy (comparison) and next five received fifteen exergame sessions over 3 weeks and physiotherapy (case) (NCT0376907). Feasibility indicators evaluated recruitment, questionnaire and exergame completion. Faces Pain Scale-Revised (FPS-R), PROMIS Pediatric Pain Interference Scale (PPIS), and KIDSCREEN-27 were administered. Wilcoxon signed-rank and effect size (r) tests evaluated within-group differences and between-group differences were assessed using Mann-Whitney U tests.Results: All feasibility indicators were met. Large effects for improved case group pain were identified (FPS-R r = 0.60, PPIS r = 0.58), as well as significant improvement in KIDSCREEN-27 total (U = 0.50, p = .05) and psychological well-being (U = 3.00, p = .01) scores, favoring the case group.Conclusions: Incorporating pediatric exergames is feasible and demonstrates potential for improving pain and well-being.

What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for stroke? A stakeholder interview study.

OBJECTIVES: Early phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation. DESIGN: Semistructured interview study. SETTING: Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling. PARTICIPANTS: Thirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews. METHODS: Interview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified. RESULTS: Most patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility. CONCLUSIONS: This novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.