Table 1.
Measures and timeframes
| Construct | Measure | Source | Time point | |||
|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | |||
| Face validity(33) | Five cliniciansb rated how well the instrument appeared to support PIVC insertion and DIVA recognition using a 5-point Likert scale 1 (strongly disagree) - 5 (strongly agree). | Cl | a | |||
| Content validity [31, 32] | Five experts examined the DIVA Key’s content validity using measures of relevancy, clarity, and simplicity for each item. | Cl | a | |||
| Agreement [33] | Interrater agreement of the instrument was assessed using percentage concordance (agreement parameter) between the assessors. | CRF | a | |||
| Reliability [34] | Instrument reliability of the DIVA Key was assessed using Kappa. | CRF | a | |||
| Consumer acceptability | Consumers (patient if > 8 years and/or parent representative) will be asked to rate their satisfaction with the DIVA instrument and escalation pathway (2 measures) using an 11-point numerical scale (0–10). | P, C | a | |||
| Clinician acceptability | The inserter (clinician) will be asked to rate their satisfaction with the DIVA Key (peripheral vein assessment instrument and escalation pathway) using an 11-point numerical scale (0–10) and filed notes. | Cl | a | |||
| Utility | PIVC insertions that are referred to an advanced practitioner that go on to be inserted by an advanced practitioner. | CRF | a | |||
| PIVC insertions requiring USG that receive USG technology | CRF | a | ||||
| Performance | First time insertion success: The number of PIVCs successfully inserted on first needle puncture as evidenced by blood flashback and ability to infuse 2-10 mL (age appropriate) 0.9% sodium chloride without signs of swelling or pain at the insertion site [18, 35, 36]. | CRF | a | |||
| Total number of PIVC insertion attempts (skin punctures) to successfully insert PIVC [36]. | CRF | a | ||||
| PIVC failure prior to the completion of therapy, per 1000 catheter days [37]. | iEMR | a | ||||
CRF Case report form, iEMR Integrated electronic medical records, P Parent reported measure, C Child reported measure, Cl Clinician, Time point 0 Instrument development, Time point 1 At point of identification of indication for PIVC, Time point 2 Post PIVC insertion; Time point 3 PIVC removal or failure. DIVA Difficult intravenous access, PIVC Peripheral intravenous catheter; USG Ultrasound guidance
aMeasure administered at this time point
bTwo doctors, three nurses