Development and validation of a tool for ambulatory monitoring of peripherally inserted central catheter-associated complications

Introduction: Peripherally inserted central catheters (PICC) are the preferred vascular access for Outpatient Parenteral Antimicrobial Therapy (OPAT) due to user-friendliness and high safety level. Nevertheless, the lack of a validated tool hampers the yet ill-charted epidemiology and monitoring of PICC related complications in ambulatory care. Methods: A sequential exploratory mixed-method three phase research design was used to develop and validate a monitoring tool for PICC complications in OPAT. A literature review and co-design approach allowed its development, followed by Delphi panel content validation. In a third phase, the tool was piloted and implemented for further evaluation, including adherence. Results: Twelve and nine experts respectively participated in the first and second Delphi round (response rate: 92% resp. 69%). Scale-level Content Validity Index based on the Average Method was 0.99 and 0.90 in the first and the second Delphi round respectively. After the Delphi procedure, the tool consisted of the following relevant items: (1) functionality (injection and aspiration), (2) insertion site, (3) catheter fixation, (4) infection and (5) thrombosis. After positive pilot testing, the tool was implemented in 17 participants with outcomes measured in 15 participants. Two participants were readmitted and three experienced PICC complications. As for adherence, the monitoring tool was partially or fully completed 285 times (74,8%); external catheter length was rarely or never reported and systematic follow-up of the temperature scored poorly. Conclusion: A tool for ambulatory monitoring of PICC-associated complications with a solid content validity was obtained. Future research should consist of a multicentric larger size assessment and digitalization.