Development of a Peripheral Venous Catheter-Associated Phlebitis Risk Scale: A Methodological Study.

Background/

Objectives

To develop and validate a multidimensional risk assessment scale for identifying patients at risk of peripheral venous catheter (PVC)-associated phlebitis.

Methods

This methodological study followed a two-phase design. In Phase 1 (scale development), an initial item pool of 39 candidate items was generated from a focused literature review and refined using the Lawshe technique with 20 expert raters. Data were collected from 729 hospitalized patients, who contributed 1008 PVCs between February and September 2021. Because the scale items are catheter-level, the PVC was the unit of analysis: 502 PVCs (from 380 patients) were used for exploratory factor analysis (EFA), and 506 PVCs (from 349 patients) for confirmatory factor analysis (CFA). In Phase 2 (clinical application), the finalized scale was administered to a separate, independent cohort of 208 patients between September and October 2021 alongside the Infusion Nurses Society (INS) Phlebitis Scale. Reliability was assessed using the Kuder-Richardson 20 (KR-20) coefficient, and discriminative performance was evaluated with Receiver Operating Characteristic (ROC) curve analysis.

Results

EFA and CFA confirmed a three-factor structure comprising 14 items distributed across Individual, Chemical, and Mechanical risk domains. The instrument demonstrated strong internal consistency (KR-20 = 0.823) and excellent discriminative accuracy (AUC = 0.898), with an optimal cut-off of 20.5 (sensitivity 87%, specificity 91%). All CFA fit indices met the conventional acceptability thresholds (χ2/df = 3.249; GFI = 0.943; AGFI = 0.914; CFI = 0.942; NFI = 0.919; IFI = 0.943; TLI = 0.925; RMSEA = 0.067). In Phase 2, scale scores correlated significantly with the INS Phlebitis Scale (r = 0.794, p < 0.001).

Conclusions

The Risk Assessment Scale for PVC-Associated Phlebitis is a valid and reliable instrument with strong psychometric properties. It enables early identification of high-risk patients and supports targeted preventive strategies in clinical practice.