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

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

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

Feasibility and reliability of frailty assessment in the critically ill: a systematic review

Background. For healthcare systems, an ageing population poses challenges in the delivery of equitable and effective care. Frailty assessment has the potential to improve care in the intensive care setting, but applying assessment tools in critical illness may be problematic. The aim of this systematic review was to evaluate evidence for the feasibility and reliability of frailty assessment in critical care. Methods. Our primary search was conducted in Medline, Medline In-process, EMBASE, CINAHL, PsycINFO, AMED, Cochrane Database of Systematic Reviews, and Web of Science (January 2001 to October 2017). We included observational studies reporting data on feasibility and reliability of frailty assessment in critical care setting in patients 16 years and older. Feasibility was assessed in terms of timing of evaluation, the background, training and expertise required for assessors, and reliance upon proxy input. Reliability was assessed in terms of inter-rater reliability. Results. Data from 11 study publications are included, representing eight study cohorts and 7761 patients. Proxy involvement in frailty assessment ranged from 58- 100%. Feasibility data were not well-reported overall, but the exclusion rate due to lack of proxy availability ranged from 0 to 45%, the highest rate observed where family involvement was mandatory and the assessment tool relatively complex (Frailty Index, FI). Conventional elements of Frailty Phenotype (FP) assessment required modification prior to use in two studies. Clinical staff tended to use a simple judgement-based tool, the Clinical Frailty Scale (CFS). Inter-rater reliability was reported in one study using the CFS and although a good level of agreement was observed between clinician assessments, this was a small and single centre study. Conclusion. Though of unproven reliability in the critically ill, CFS was the tool used most widely by critical care clinical staff. Conventional FP assessment required modification for general application in critical care, and a FI-based assessment may be difficult to deliver by the critical care team on a routine basis. There is a high reliance on proxies for frailty assessment, and the reliability of frailty assessment tools in critical care needs further evaluation. PROSPERO CRD42016052073

Early mobilisation in mechanically ventilated patients:A systematic integrative review of definitions and activities

From PubMed via Jisc Publications RouterHistory: received 2018-10-23, accepted 2018-12-11Publication status: epublishMechanically ventilated patients often develop muscle weakness post-intensive care admission. Current evidence suggests that early mobilisation of these patients can be an effective intervention in improving their outcomes. However, what constitutes early mobilisation in mechanically ventilated patients (EM-MV) remains unclear. We aimed to systematically explore the definitions and activity types of EM-MV in the literature. Whittemore and Knafl's framework guided this review. CINAHL, MEDLINE, EMBASE, PsycINFO, ASSIA, and Cochrane Library were searched to capture studies from 2000 to 2018, combined with hand search of grey literature and reference lists of included studies. The Critical Appraisal Skills Programme tools were used to assess the methodological quality of included studies. Data extraction and quality assessment of studies were performed independently by each reviewer before coming together in sub-groups for discussion and agreement. An inductive and data-driven thematic analysis was undertaken on verbatim extracts of EM-MV definitions and activities in included studies. Seventy-six studies were included from which four major themes were inferred: (1) , (2) , (3) and (4) . The first theme indicates that EM-MV is either not fully defined in studies or when a definition is provided this is not standardised across studies. The remaining themes reflect the diversity of EM-MV activities which depends on patients' characteristics and ICU settings; the negotiated decision-making process between patients and staff; and their interdependent relationship during the implementation. This review highlights the absence of an agreed definition and on what constitutes early mobilisation in mechanically ventilated patients. To advance research and practice an agreed and shared definition is a pre-requisite