Table 2.

Representative examples of barriers and facilitators to performing the multi-centre prospective biomarker study and PICU institutional urine collection protocol.

Barriers
Barrier	Explanation and Implication	Rectification/Improvements
Data issues
PICU admission time discrepancy between sources	Discrepant in electronic records (EMR) and paper chart. Affects eligibility and Pediatric Risk of Mortality (PRISM) score window	PICU clerk keeps time log. Use if available. If not, chart, then EMR
Glascow coma score (GCS): sedated/non-sedated assessment	Sedation status not always collected, thus unable to be certain recorded GCS was definitely non- sedated	Queries sent; sedatives list added to case report form (CRF) instructions
Daily drugs, events data Incomplete	Clarity issues on which study day corresponded to a PICU day	CRF table titles and instructions modified, simpler. Queries sent
CRF instructions lacking	Assuming research assistant (RA) knowledge for some variables causes data variability	Every data point described in detail in final CRF instructions
Data entry errors	Certain variables more error prone	Monthly data clean; 10% reentry
Height not always available	Crucial to estimate baseline glomerular filtration rate (GFR); often not recorded in chart	Systematically measure height at recruitment or shortly after
Clinical staff issues
Day 1 –3 urine not always collected per protocol	PICU nurses did not always collect daily urine during the clinical protocol (in most cases, stated to have forgotten)	Order form to collect daily urine, added to admission package
Urine not collected on PICU discharge day	Ward nurses not all informed of study. PICU nurse sometimes did not collect urine on day of PICU to ward transfer	RA sees patient every study day; Involve parents; reminders; Fridays, speak to nurse and clerk
Sites differ in nurse “shift intervals”	Affects study day start time. Affects time needed for data collection	A uniform CRF to account for inter-site variations in shift times
PICU staff schedule changes	Nurse and resident rotations, “new faces” not always familiar with the study	Study reminders; urine collection order sheet; new staff tracking
Lab issues
Site lab results reporting (units) differ	E.g., bilirubin, FiO2, Mostly affected PRISM calculation	Conversion tables added to CRF instructions
Leftover serum use, when no routine SCr measured	Leftover serum from central lab used to measure SCr when not available. Some sites not always able to easily obtain	Some sites need specific process to obtain serum from central lab. Site- specific process set up
Other
Missing weekend patients potential	Mostly Friday admission with Monday discharge to home and not ward. Reviewed: small number	Protocol dictates urine collection 7 days/week. Monday AM priority to recruit such patients first
No routine PICU blood draws	Results in no SCr. Reviewed: small number, low- risk, short stay patients	Minimum SCr criteria included in inclusion criteria; draw study blood if not routinely drawn
Parent accessibility, significant “back and forth to PICU”	Parents leave PICU often, challenge for consent; patient tests (e.g. imaging); time and cost concern	Provide RA/site investigator pager to nurses; involve site investigator on non- RA hours.
Facilitators
Facilitator	Explanation	Product
Involving Head Nurse in planning	Re: study initiation and maintenance	Nurses more aware, reminded of urine protocol. Head nurses is research team member or involved in designing site- specific study feasibility methods
RA/site investigator PICU presence	Having one study RA puts a face to the study; helped remind staff of study	Prefer consistent RA over “hospital research service”, unless research service has constant presence.
Deferred consent, during/after PICU-wide urine protocol collection	At recruitment, urine often available from the first 2–3 PICU days; i.e. protocol successful to obtain early PICU urines; accepted by nurse staff	The PICU-wide urine collection protocol will be used for future studies
Simple PICU-wide urine collection protocol for nurses	Focus on urine collection without nurse screening work; all patients; PICU staff not confused by the protocol	The PICU-wide urine collection protocol will be used for future studies.