ABSTRACT
BACKGROUND/AIMS: Actively engaging patient partners in the conduct of trials is crucial to ensure the studies answer genuine, patient-centered, unmet clinical needs, and to facilitate participant recruitment and retention. The aim of this article is to demonstrate the feasibility of patient engagement within a large pragmatic multicenter randomized controlled trial, specifically for the purposes of dissemination of study information/updates and to favorize recruitment and retention. METHODS: In the patient-centric, pragmatic ADAPTABLE randomized trial, transparent and timely dissemination of information on the study updates to the trial participants was undertaken to create meaningful engagement and to facilitate retention. A national panel of patient partners, the Adaptors, were directly involved in this information dissemination strategy, and study participants were engaged both nationally and locally to design recruitment methods iteratively during the conduct of the trial. All Adaptors had a lived experience with cardiovascular disease. RESULTS: Adaptors attended bi-weekly meetings facilitated by the director of the study's patient-powered research network. They drafted and/or edited newsletters and ad hoc educational information written in a lay-friendly manner for study participants, which were regularly distributed to the ADAPTABLE community, in addition to online forums where participants could share their experience of their involvement in ADAPTABLE. To spur recruitment, a patient-driven initiative was to draft letters sharing their story, which were distributed by the local study teams. Patient partners thought that using patients' voice to provide their perspectives on why they believed this project was important would be more engaging for prospective participants than traditional approaches. CONCLUSIONS: ADAPTABLE's experience has demonstrated the feasibility of engaging patients as partners in the conduct of a large-scale, multi-center, pragmatic randomized controlled trial. Future trials should embrace and iteratively improve this model by engaging patient partners as early as study protocol development and funding applications, and quantify its impact on the effectiveness and value of the trial.
Subject(s)
Patient Participation , Research Design , Humans , Prospective Studies , Randomized Controlled Trials as Topic , Information DisseminationABSTRACT
Introduction: Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings. Methods: Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications. Results: Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement. Conclusions: The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.
ABSTRACT
Traditional airway maintenance and clearance therapy and principles of application are similar for neonates, children, and adults. Yet there are distinct differences in physiology and pathology between children and adults that limit the routine application of adult-derived airway-clearance techniques in children. This paper focuses on airway-clearance techniques and airway maintenance in the pediatric patient with acute respiratory disease, specifically, those used in the hospital environment, prevailing lung characteristics that may arise during exacerbations, and the differences in physiologic processes unique to infants and children. One of the staples of respiratory care has been chest physiotherapy and postural drainage. Many new airway clearance and maintenance techniques have evolved, but few have demonstrated true efficacy in the pediatric patient population. Much of this is probably due to the limited ability to assess outcome and/or choose a proper disease-specific or age-specific modality. Airway-clearance techniques consume a substantial amount of time and equipment. Available disease-specific evidence of airway-clearance techniques and airway maintenance will be discussed whenever possible. Unfortunately, more questions than answers remain.
