Hypersensitivity in patients receiving metal implants: a scoping review protocol

Abstract

Objective: The objective of this scoping review is to gather the available evidence on metal hypersensitivity to determine the extent of the problem and identify gaps in the evidence about screening practices. Introduction: Hypersensitivity to metal was first reported in 1966. Since this time, the use of metal in prosthetic devices has increased with an associated rise in reported hypersensitivity reaction to other metals. Symptoms of metal hypersensitivity can be subtle, and it is unclear whether clinicians are aware of or routinely ask patients about metal hypersensitivity when documenting allergies. This can lead to a delay in diagnosis, which puts patients at risk of poor outcomes. Hence, there is a need to map the available evidence on hypersensitivity reaction in people who receive metallic device implantation. Inclusion criteria: The review will consider studies that include patients who undergo procedures involving metal implantation. The concept to be explored is hypersensitivity following a procedure that involves the implementation of a device with metal components. Implementation is defined as permanent integration of a foreign (non-biological) object into the human body to restore function. Methods: The proposed scoping review will be conducted in accordance with JBI methodology for scoping reviews. Searches will be generated in multiple databases and updated as needed. Gray literature and organizational websites will also be searched. Titles, abstracts, and full articles will be screened according to the inclusion criteria. Studies published in English from 1960 to the present will be included. Data will be extracted and findings will be presented in tabular form with a narrative summary.

The lived experiences of metal hypersensitivity

“…Based on our scoping review, 29 this is the first qualitative study to explore the experiences of patients with hypersensitivity reactions following implantable medical devices. The findings highlight a major theme of "unknowing" on the parts of the patients and the healthcare system.…”

“…We discussed the findings of our previous studies. 8,29 The patient partner noted that the enablers and barriers identified by the healthcare workers about screening for hypersensitivity reaction to metal 8 did not consider the issue of informed consent. This discussion led to the overarching research question: “Among patients with metal hypersensitivity, what information would have helped them make an informed decision about metal implants?” We used interpretative phenomenology because it allows us to use the informants’ experiences as well as integrating our own experiences as healthcare providers to patients requiring surgery and those with hypersensitivity reactions.…”

“…We discussed the findings of our previous studies. 8,29 The patient partner noted that the enablers and barriers identified by the healthcare workers about screening for hypersensitivity reaction to metal 8 did not consider the issue of informed consent. This discussion led to the overarching research question: "Among patients with metal hypersensitivity, what information would have helped them make an informed decision about metal implants?"…”

Patient Journey Map: Metal Hypersensitivity

“…This study also provided an opportunity for the participants to have a voice and discuss their experiences as our previous literature review failed to identify any qualitative studies that detailed the patient experience from their perspective. 34 …”

“…This study also provided an opportunity for the participants to have a voice and discuss their experiences as our previous literature review failed to identify any qualitative studies that detailed the patient experience from their perspective. 34 The main limitation of this study is the lack of comprehensive health utilization data to determine the economic burden of MH. The use of retrospective data is prone to recall bias while the use of snowballing sampling could result in selection bias.…”