Improving care quality and delivery for people with Alzheimer disease and related dementias (ADRD) requires a comprehensive research agenda that encompasses the entire care continuum. Logistical and ethical challenges of informed consent for research participation of persons with ADRD include determination of capacity to consent, surrogate consent when capacity to consent is compromised, timely identification of the legally authorized representative (LAR) providing surrogate consent, and balancing residual autonomy with surrogate consent. These challenges are compounded in the acute care setting by short stays, limited access to patients, caregivers, and LARs, and the fluctuating influences of acute illness on capacity determination. To address these challenges, we worked with our Institutional Review Board to develop a procedural framework for obtaining informed consent from hospitalized ADRD patients and caregivers to participate in a minimal risk care intervention. The framework is specially designed for minimal risk situations where rapid enrollment is a necessity, and engages: 1) Rapid identification of surrogates to consent for patients who lack legal capacity to make medical decisions indicated by an activated health care power of attorney (HCPOA), and 2) Individualized formal assent procedures for patients who lack capacity to consent. These methods have proven effective in facilitating hospital-based recruitment in an ongoing randomized controlled trial, and provide a basis for increasing access to acute care clinical research for persons with ADRD. Bolstering research participation through more readily engaged consent procedures during acute illness is critical to fostering improvements in the delivery of high quality care to persons with ADRD.
Research staff identify eligible inpatients in the electronic medical record (EMR) Research staff gather initial information about capacity, health status, discharge disposition, and caregiver in the EMR Approach the patient and caregiver in the hospital with the inpatient nursing partner Adjust physical environment to facilitate communication with patients Research staff describe the study, determine eligibility, and enroll the patient if appropriate Frequent communication between research staff and inpatient nursing partners both in person and over telephone Tools and technologies EMR Concise study scripts Cellular phones to facilitate communication between the research team, inpatient nursing partners and participants (as needed) Tablet computers used by research staff to access study scripts and study databases for real-time data entry Organization Health system support for recruitment activities in the hospital Research team granted access to the EMR Research team meetings to address recruitment facilitators and barriers, and to evaluate recruitment data Flexible scheduling to accommodate rapidly changing inpatient environment Physical environment Patient comfortable in hospital bed or seated in chair Research staff and inpatient nursing partners positioned to make eye contact and engage with patients appropriately Adjust lighting in the hospital room Close hospital room door for privacy and noise reduction Mute or turn off television Ensure patient has access to hearing aids, glasses, and other assistive devices
Cytochrome P450 epoxygenase isozymes convert free arachidonic acid into eicosanoids named epoxyeicosatrienoic acids (EETs) that have roles in regulating inflammation. EETs are rapidly converted to dihydroxyeicosatrienoic acids (DiHETs) by soluble epoxide hydrolase (sEH). Little is known about the potential role of these metabolites in uveitis, but conversion of EETs to DiHETs could contribute to the inflammation. We tested a potent and orally available inhibitor of sEH for its ability to reduce ocular inflammation in a rabbit LPS-induced model of uveitis. Rabbits were treated by subcutaneous injection with the sEH inhibitor (UC1728, 3 mg/kg), or the vehicle control (PEG400) and uveitis was assessed at 6, 24 and 48 h post-intracameral LPS injection using a modified Hackett-McDonald scoring system. Eyes treated by intra-cameral injection of PBS, or by aseptic preparation served as further controls. Signs of inflammation in this model were mild and transient. Treatment with UC1728 did not significantly reduce inflammation compared to animals treated with the PEG400 vehicle. Blood levels of UC1728 were a thousand fold higher than the in vitro determined inhibitory potency (IC50) of the compound suggesting a significant degree of inhibition of sEH in the rabbit. The lack of efficacy suggests that sEH or its substrates the EETs may not be involved in mediating inflammation in this model of uveitis.
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