Participant retention practices in longitudinal clinical research studies with high retention rates

Abstract Background There is a need for improving cohort retention in longitudinal studies. Our objective was to identify cohort retention strategies and implementation approaches used in studies with high retention rates. Methods Longitudinal studies with ≥200 participants, ≥80% retention rates over ≥1 year of follow-up were queried from an Institutional Review Board database at a large research-intensive U.S. university; additional studies were identified through networking. Nineteen (86%) of 22 eligible studies agreed to participate. Through in-depth semi-structured interviews, participants provided retention strategies based on themes identified from previous literature reviews. Synthesis of data was completed by a multidisciplinary team. Results The most commonly used retention strategies were: study reminders, study visit characteristics, emphasizing study benefits, and contact/scheduling strategies. The research teams were well-functioning, organized, and persistent. Additionally, teams tailored their strategies to their participants, often adapting and innovating their approaches. Conclusions These studies included specialized and persistent teams and utilized tailored strategies specific to their cohort and individual participants. Studies’ written protocols and published manuscripts often did not reflect the varied strategies employed and adapted through the duration of study. Appropriate retention strategy use requires cultural sensitivity and more research is needed to identify how strategy use varies globally

COVID-19 and Pregnancy Outcomes: An Increased Risk of Intrauterine Inflammation/Infection

Objective: The objective of this study is to determine the association between COVID-19 infection and pregnancy outcomes at our institution when universal testing was implemented for all patients admitted to Labor & Delivery. Methods: This was an IRB-exempt, retrospective chart review of all obstetrical patients admitted and evaluated in L&D from March 30th to April 30th. COVID-19 testing was performed on all patients who were admitted and their support person, irrespective of the presence of symptoms. Data analysis was performed with baseline demographics compared. Continuous variables were compared via T-test and categorical values using Chi-square and Fisher exact. Significant values are those considered with p < .05. Results: There were no differences in delivery outcomes between the two groups with regards to mode of delivery, preterm labor, premature rupture of membranes, preeclampsia, placental abruption, or fetal demise. However, there was an increase in intrauterine infection/inflammation among COVID positive patients (8.8% compare to 1.4%, p < .05) ('Tables 1' and '2'). Conclusions: COVID positive patients were noted to have an increase in intrauterine infection/inflammation. Current published data demonstrates that SARS-Cov-2 infection during 3rd trimester of pregnancy is not associated with vertical transmission. “However, the possibility of viral load influencing the transmission risk should be of concern. Published studies have demonstrated a positive relationship between the viral load of some viruses and their ability to spread from mother to child” [1]. Given our findings, the possibility of SARS-CoV-2 infection resulting in intrauterine infection/inflammation should be further evaluated as the pandemic continues

Survivorship After Neurocritical Care: A Scoping Review of Outcomes Beyond Physical Status

Following intensive care unit hospitalization, survivors of acute neurological injury often experience debilitating short-term and long-term impairments. Although the physical/motor impairments experienced by survivors of acute neurological injury have been described extensively, fewer studies have examined cognitive, mental health, health-related quality of life (HRQoL), and employment outcomes. This scoping review describes the publication landscape beyond physical and/or motor sequelae in neurocritical care survivors. Databases were searched for terms related to critical illness, intensive care, and outcomes from January 1970 to March 2022. English-language studies of critically ill adults with a primary neurological diagnosis were included if they reported on at least one outcome of interest: cognition, mental health, HRQoL or employment. Data extraction was performed in duplicate for prespecified variables related to study outcomes. Of 16,036 abstracts screened, 74 citations were identified for inclusion. The studies encompassed seven worldwide regions and eight neurocritical diagnosis categories. Publications reporting outcomes of interest increased from 3 before the year 2000 to 71 after. Follow-up time points included ≤ 1 (n = 15 [20%] citations), 3 (n = 28 [38%]), 6 (n = 28 [38%]), and 12 (n = 21 [28%]) months and 1 to 5 (n = 19 [26%]) and &gt; 5&nbsp;years (n = 8 [11%]), with 28 (38%) citations evaluating outcomes at multiple time points. Sixty-six assessment tools were used to evaluate the four outcomes of interest: 22 evaluating HRQoL (56 [76%] citations), 21 evaluating cognition (20 [27%] citations), 21 evaluating mental health (18 [24%] citations), and 2 evaluating employment (9 [12%] citations). This scoping review aimed to better understand the literature landscape regarding nonphysical outcomes in survivors of neurocritical care. Although a rising number of publications highlight growing awareness, future efforts are needed to improve study consistency and comparability and characterize outcomes in a disease-specific manner, including outlining of a minimum core outcomes set and associated assessment tools

Impact of a Multifaceted Early Mobility Intervention for Critically Ill Children - the PICU Up! Trial: Study Protocol for a Multicenter Stepped-Wedge Cluster Randomized Controlled Trial

BACKGROUND: Over 50% of all critically ill children develop preventable intensive care unit-acquired morbidity. Early and progressive mobility is associated with improved outcomes in critically ill adults including shortened duration of mechanical ventilation and improved muscle strength. However, the clinical effectiveness of early and progressive mobility in the pediatric intensive care unit has never been rigorously studied. The objective of the study is to evaluate if the PICU Up! intervention, delivered in real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children. Additionally, the study aims to identify factors associated with reliable PICU Up! delivery. METHODS: The PICU Up! trial is a stepped-wedge, cluster-randomized trial of a pragmatic, interprofessional, and multifaceted early mobility intervention (PICU Up!) conducted in 10 pediatric intensive care units (PICUs). The trial\u27s primary outcome is days alive free of mechanical ventilation (through day 21). Secondary outcomes include days alive and delirium- and coma-free (ADCF), days alive and coma-free (ACF), days alive, as well as functional status at the earlier of PICU discharge or day 21. Over a 2-year period, data will be collected on 1,440 PICU patients. The study includes an embedded process evaluation to identify factors associated with reliable PICU Up! delivery. DISCUSSION: This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and functional outcomes in critically ill children. This study will provide new and important evidence on ways to optimize short and long-term outcomes for pediatric patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04989790. Registered on August 4, 2021

Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study

Objective To evaluate the association of volume limited and pressure limited (lung protective) mechanical ventilation with two year survival in patients with acute lung injury

Evaluating muscle mass in survivors of ARDS: a 1-year multicenter longitudinal study

Objective—Rapid muscle wasting occurs during acute respiratory failure, resulting in muscle weakness and functional impairments. This study examines survivors’ body composition in the year after acute respiratory distress syndrome (ARDS) and tests associations of patient characteristics, hospital exposures, and survivors’ strength and physical functioning with whole body percent lean mass. Design—Prospective cohort study with 6- and 12-month follow-up Setting—National study enrolling patients from 5 study centers Patients—ARDS survivors (N=120) Interventions—None Measurements and Main Results—Lean and fat mass from dual energy X-ray absorptiometry (DXA). On average, survivors gained whole body total mass (+1.4kg, 0.1, 2.7) and fat mass (+1.2 kg, 0.2, 2.2), and maintained lean mass (+0.2kg, −0.4, 0.8) between 6 and 12 months. Proportionally, percent fat mass increased and percent lean mass decreased for the whole body, trunk, and legs (p Conclusions—In the first year after ARDS, patients gained fat mass and maintained lean mass. We found no association of whole body percent lean mass with commonly-hypothesized hospital risk factors. Direct measurement of body composition and performance-based functional measures may be helpful for understanding functional recovery in ICU survivors

Factors influencing physical activity and rehabilitation in survivors of critical illness: a systematic review of quantitative and qualitative studies

PURPOSE: To identify, evaluate and synthesise studies examining the barriers and enablers for survivors of critical illness to participate in physical activity in the ICU and post-ICU settings from the perspective of patients, caregivers and healthcare providers. METHODS: Systematic review of articles using five electronic databases: MEDLINE, CINAHL, EMBASE, Cochrane Library, Scopus. Quantitative and qualitative studies that were published in English in a peer-reviewed journal and assessed barriers or enablers for survivors of critical illness to perform physical activity were included. Prospero ID: CRD42016035454. RESULTS: Eighty-nine papers were included. Five major themes and 28 sub-themes were identified, encompassing: (1) patient physical and psychological capability to perform physical activity, including delirium, sedation, illness severity, comorbidities, weakness, anxiety, confidence and motivation; (2) safety influences, including physiological stability and concern for lines, e.g. risk of dislodgement; (3) culture and team influences, including leadership, interprofessional communication, administrative buy-in, clinician expertise and knowledge; (4) motivation and beliefs regarding the benefits/risks; and (5) environmental influences, including funding, access to rehabilitation programs, staffing and equipment. CONCLUSIONS: The main barriers identified were patient physical and psychological capability to perform physical activity, safety concerns, lack of leadership and ICU culture of mobility, lack of interprofessional communication, expertise and knowledge, and lack of staffing/equipment and funding to provide rehabilitation programs. Barriers and enablers are multidimensional and span diverse factors. The majority of these barriers are modifiable and can be targeted in future clinical practice