Patient perspectives on the need for implanted device information: Implications for a post‐procedural communication framework

Abstract Background Shared decision making and patient‐centred communication have become part of pre‐procedural decisions and perioperative care across medical specialties. However, gaps exist in patient communication about the implanted device received and the benefits in sharing information about their procedure and device. Objective To understand the patients' knowledge of identifying information for their implanted devices and perspectives on sharing their implanted device information. Methods Four focus groups were conducted with patients who had received a cardiac or vascular implanted device from one of the study sites within the previous 6 months. Data were transcribed and thematically analysed. Results Five themes emerged: lack of awareness of identifying information on implanted devices; value of information on implanted devices; varying trust with sharing device information; perceived risk with sharing device information; and lack of consensus on a systematic process for tracking implanted devices. Discussion Patients desire post‐procedural information on their implanted device and a designated plan for longitudinal follow‐up, but lack trust and perceive risk with broadly sharing their implanted device information. Conclusion After receiving an implanted device, post‐procedural patient communication needs to be expanded to include identifying information on the device including the unique device identifier, how long‐term tracking will be supported and the process for notification in case of a problem with the device. This communication should also include education on how sharing device information supports patients' long‐term health care, post‐market safety surveillance and research. Patient or Public Contribution The research team included members who were also patients with implanted devices.


| INTRODUC TI ON
Implanted devices are an important part of medical care that address patient morbidity and mortality and augment patient quality of life.
These devices that are intended to be placed in a surgically or naturally formed cavity of the human body 1 are very common in procedures across medical specialties. For example, an estimated seven million Americans are living with a hip or knee replacement. 2 Over 500 000 procedures involving a pacemaker or cardioverter/defibrillator were performed in the United States in 2014. 3 Approximately 480 000 inpatient percutaneous coronary interventions were performed in the United States in 2014, most involving implantation of one or more cardiac stents. 4 Despite the benefits for patients, problems occur with medical devices over their lifespan that may impact patient health, wellbeing and safety. Examples include the high profile recalls of cardioverter/defibrillator leads 5 and metal-on-metal hip implants, 6 complications with surgical mesh used in urogynaecologic procedures 7 and the Essure device, 8 association of breast implants with anaplastic large cell lymphoma, 9 increased risks of stent thrombosis with first-generation drug-eluting stents 10 and a potential mortality risk associated with paclitaxel-containing device use. 11,12 Shared decision making and patient-centred communication have increasingly become part of pre-procedural decisions and perioperative care across medical specialties. [13][14][15] They foster exchange of information relevant to patients and patients' involvement in their health care, decisions, self-management and satisfaction. [16][17][18] Frameworks and checklists have helped support the patient pre-and post-procedure and with the transition from the health-care system at discharge, with much of this focus on recovery and follow-up. [19][20][21] However, gaps exist in communication surrounding the implanted device a patient receives. Lacking is a standard method for all patients to receive identifying information including the unique device identifier (UDI) on their implanted device, communication about the process that will be followed if a problem with their implanted device (eg safety alert, recall) arises in the future, and in some cases detailed information on the functioning of the device they have received. 22 In addition, communication to patients is scant regarding how sharing of information about their procedure and implanted device benefits their long-term health care through device tracking, post-market safety surveillance and research. 23,24 This work was part of a larger study (UDI2Claims) to develop a process to transmit UDIs for devices implanted in patients during procedures to insurance claims. 25,26 As part of the United States Food and Drug Administration's framework to advance medical device safety, a UDI system was established through issuance of the Unique Device Identification System Rule in 2013. The Rule mandates manufacturers to include UDIs on the labels and packaging of their marketed devices. 27 (components of the UDI are a device identifier (DI) that identifies the manufacturer and model and the production identifier (PI) that identifies, as available, the lot number, serial number and expiration date 28 ). The UDI can be scanned during a patient procedure and documented in the patient's electronic health record where it is available for multiple uses such as sharing with the patient, implant identification in clinical care and aggregation with other device data for post-market safety surveillance and research. 29 The European Union has also mandated a UDI System through its Medical Device Regulations with dates of compliance starting in 2021. 30 The aim of the work reported here was to answer the following research questions: (a) Are patients aware of identifying information for their implanted device including the UDI? (b) Do patients want information on their implanted device shared? And (c) what are the critical influences that guide their view?

| Settings and participant selection
The study settings were two hospitals in the United States, Brigham and Women's Hospital (BWH) and Geisinger Health (GH), as part of the larger UDI2Claims study. Four focus groups were conducted, with one at each site in June 2017 and again in April 2019. Purposive sampling was utilized. Criterion for inclusion in a focus group was patients who had received a cardiac or vascular implanted device at BWH or GH in the 6 months prior to the focus group. Lists of patients meeting this criterion were generated by clinical staff at BWH and GH through evaluation of electronic health records.
Potential participants from BWH and GH were contacted and invited to participate in a ninety-minute focus group. Patients who agreed to participate received a phone reminder a few days prior to the focus group date. The study was approved by the Partners Office of Research Integrity and Assurance. Prior to commencement of the focus groups, participants completed a registration questionnaire and were orally consented. The questionnaire asked about information on their device and listed a number of possible concerns, one example being 'No one is tracking the device nationally to find out problems'. Responses used a 4-point Likert scale ranging from 1 (very worrisome), 2 (somewhat worrisome), 3 (a little worrisome) to 4 (not worrisome at all). One researcher led and facilitated each focus group using the focus group guide developed by the research team. One to two additional research team members were present at focus groups to take notes.

| Guide and data collection
Upon completion of the focus group sessions, participants were provided information and encouraged to contact researchers with any further thoughts or perceptions they wished to share. Audio recordings of the focus group sessions were obtained and transcribed.

| Data analysis
Four focus groups were scheduled, and it was determined after preliminary analysis that data saturation was adequate and further sampling was not necessary. Transcribed audio recordings were analysed utilizing a multi-step process, guided by Ritchie and Lewis' Framework Technique. 31 Two members of the research team experienced in qualitative research methods independently familiarized themselves with the data by reviewing the transcripts and created a list of inductive codes. The researchers compared their independent findings and agreed upon a thematic framework. This was then applied to the transcripts. Key data for each theme were obtained, and representative quotes were identified. Through an iterative process, disagreements were adjudicated, and a consensus was reached on major themes and subthemes from the focus groups. Data management was manual.
Descriptive statistics were used to analyse the registration questionnaire. Data were aggregated and organized using Microsoft Excel.

| RE SULTS
Twenty-four patients participated in the four focus groups. A majority were over the age of 65 (58%), female (54%) and had at least some college education (66%). Ninety-five percentage of participants reported White race. For insurance status, a mix of Medicare and private insurance coverage was reported (Table 1).
In terms of patient concerns regarding their implanted device, on average, patients reported 'a little worrisome' (3.1-3.4). This included 'no one is tracking the device nationally to find out problems' ( Table 2).
Five key themes with associated subthemes emerged across the focus groups: (a) lack of awareness of identifying information on implanted devices, (b) information on implanted devices is valuable, (c) varying trust in sharing device information, (d) perceived risks with sharing device information and (e) lack of consensus on a systematic process to track implanted devices (Table 3). I did not know about (UDI), but it did not surprise me (to know devices can be identified this way), in this day and age

TA B L E 1 Participant demographics
Other participants described a lack of engagement with providers when they received their implanted devices and a lack of knowledge that information on an implant card was even available for patients.
There was the general sentiment by participants that identifying information on their implanted device was documented somewhere within the health-care system and could be accessed as needed.
(My) husband asked why I did not get a card. Made me think why I do not have one I never gave a thought to ask for a card

| Theme 2: Information on implanted devices is valuable
Patients endorsed the value of having identifying information in- The device could be recalled, and I wouldn't know it

3.4
No one is tracking the device nationally to find out problems

3.1
I can't afford it 3.1 a Patients' concerns regarding their implanted device, using a 4-point Likert scale ranging from 1 (very worrisome), 2 (somewhat worrisome), 3 (a little worrisome) to 4 (not worrisome at all).

Lack of awareness of identifying information on implanted devices
Did not know about unique device identifiers (UDIs) Did not routinely receive an implant card Unclear who may already receive their procedure or device information

| Theme 3: Varying trust in sharing device information
Patients felt most comfortable with sharing their implanted device information within the medical profession-providers who would care for them and the hospital in which they would receive care.
(I) have no problem with people knowing in the medical system Most patients also felt they should have their own information.
(You) need to be your own patient advocate Most were not interested in sharing information with the insurance company or the federal government. Trust of manufacturers was mixed, and participants overall were unclear whether manufacturers kept records of their implanted device.
I cannot imagine why they (the insurance company) would want it. I would not give it to them Why does this have to be involved with the government when tracking devices for health?
I have some concern about (manufacturers) covering up a problem

| Theme 4: Perceived risks with sharing device information
Patients perceived risk in sharing their implanted device information with insurance providers and the federal government. Subthemes included denial of insurance coverage, use that was not in their best interest and loss of privacy.
Some patients described concern that insurance providers might use the information about their implanted device against them.
What are the insurance companies going to do if they have (device identifying information)-be on the patient side or not?
Other patients expanded on this concern, although a participant in one focus group did inform others during discussion that procedural data are already shared with insurance providers for payment purposes.
(I) worry if the insurance company knows I had a stent put in 10 years ago and had a couple more put in now.
Will that be used against people?…What about some 30-year olds? Are they going to lose their health insurance because the insurance company finds out about some of these medical issues through a database? This guy has a bunch of stents in him. We need to find a reason to get rid of him because he costs hundreds of thousands of dollars.
Will insurance not take me if I have thirty-five implants?
Patients expressed general unease with the federal government having their information, although a participant in one focus group did inform others that the federal government has an enforcement responsibility where they need data, for example for recalls. If there is an issue, they may need to step in.
People do not have faith in the government  conditions that foster trust, privacy, data responsibility and purpose. [33][34][35][36] Patients are motivated to advance health-care knowledge and support their own care and that of future patients. 37 Also consistent with existing literature is weakened trust between patients and insurance companies and between patients and the federal government. Patients do not trust that these stakeholders will act in their best interest or properly protect their privacy. 36,38,39 Patients express preferences for sharing their implanted device information with clinical providers over insurers and government agencies.

| D ISCUSS I ON
Patient willingness to share data will be contingent upon addressing and mitigating their perceptions of risk.
Study limitations include that the focus groups were small and were attended by White, mostly older participants. Limited types of implanted devices were represented with a focus on cardiac and vascular surgery-implanted devices. Focus group participants were recruited from only two hospital sites in the United States, which may have narrowed the patient experiences and perceptions captured. Additionally, it is recommended that future research studies be done to augment these findings, particularly by engaging patients who received implanted devices in a broader array of procedures and medical specialty areas and engaging patients who self-identify as members of minority or underserved communities. Lastly, given the observation that some focus group members did not receive an implant card and were unaware that cards and UDIs were available, this is an important area for a focused quality improvement project at implanting facilities.

| IMPLI C ATI ON S FOR PATIENTS AND PR AC TI CE
Implementation of these recommendations will promote improved communication and understanding between patients who receive implanted devices and their providers. They support not only patients being more knowledgeable about their health care but also being engaged participants in advancing medical device safety for themselves and others. These recommendations additionally foster improved documentation of implanted devices via the UDI during the procedure, so standard information is available for patients and is available to support greater longitudinal tracking of devices and availability of data for post-market safety surveillance and research. Understanding areas that patients perceive as risks in device data sharing will inform development of a standardized system that is inclusive of education and responsive to patient preferences.
Further research and quality improvement projects can fine-tune these areas and support greater generalizability. In this way, shared decision making and patient-centred communication methods will augment care and safety for patients who receive and live with implanted devices.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. UDI will then be shared with your health insurance company, who then may or may not share it with a national registry or database.

O RCI D
The goal of the registry or database, is to have information about lots of people's devices in one place so that the effectiveness and safety of the devices can be tracked and understood. This is a study that is funded by the Patient-Centered Outcomes Research Institute.
Before we begin our discussion, I wanted to just cover a few ground rules for our discussion today.
1. There are no right or wrong answers today. Please make sure you are respectful of everyone's thoughts and opinions.
2. Please speak one at time so we make sure we can hear what everyone says.
3. Please keep confidential anything that was said in today's group.
4. Please feel free to say any names during our discussion. We will be audio recording our conversation today so we remember what everyone says. We will be deleting all names and places in the reports we write.

You do not have to answer any of the questions if you don't want
to. If you think of anything you want to add after the group today, please contact us to share.
6. We will be ending our discussion today at xxpm. I might need to move us along at different points of the conversation to make sure we cover all of the topics.
Do you have any questions before we begin?
Introductions (10 minutes) The first thing I would like to do is to have everyone introduce himself or herself and say how long they have had an implanted device.
Initial thoughts (10 minutes) ii. If the information would be used to help identify safety issues faster.

Using the information (15 minutes)
Information about your device could be used for multiple purposes. We are going to go through the different ways the information could be used and would like your feedback.
11. The first we will discuss is using stored UDIs for research

B. UDI (5 minutes)
The box in front of you is from an implanted device. This may not be the exact device you have implanted but is being used as an exam- Even though it is possible to scan the barcode and record the UDI in your electronic health record this is not being done at many hospitals.
The UDI is also generally not listed on a patient's implant wallet card that they may receive after their procedure. That's why we are doing this study. We have been working on developing a system for the UDI to be recorded in your electronic health record and then shared with your health insurance company in the insurance claim form.

C. INITIAL THOUGHTS (10 minutes)
We would like to start with getting some of your initial thoughts on the topic.