Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles: Study protocol.

ABSTRACT:

Background

Despite the wide usage of miniscalpel-needles (MSNs), information about MSN treatment-related adverse events (AEs) is insufficient. As the definition of AE might vary among physicians, without an exact definition for pain and hemorrhage, it is difficult to provide accurate information about AEs in MSN treatment to physicians, researchers, and patients. The aim of our study is to reach a consensus about the items and definitions of AEs that should be included in the survey form for prospective observational multicenter studies to record MSN treatment-related AEs. We will especially focus on obtaining a consensus on the definition of pain and hemorrhage caused by MSN treatment.

Methods

Our study protocol is composed of 6 steps. First, we will identify the aim of the

SUBMITTER: Yoon SH 

PROVIDER: S-EPMC6203508 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature