Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy

Abstract

Introduction

The outcomes of carotid surgery are commonly evaluated using parameters such as mortality and stroke. The importance of these parameters is based on doctors’ and scientific perspectives. Presently, patient centered health care aims to value the evaluation from patients’ perspective, mostly using Patient-Reported Outcomes (PROs). The true significance of outcomes of carotid surgery that matter most to the patients is largely unknown. The aim of this study is to identify and verify the patients’ perspective on carotid surgery for patients with a symptomatic and significant carotid stenosis.

Methods and Outcomes

An exploratory semi-structured focus group discussion will be used, as a quality research method. Three groups consisting of 8 patients (n = 24), who underwent the carotid endarterectomy because of a significant and symptomatic stenosis of the internal carotid artery, will be enrolled. If data saturation is not reached, the sample size will be expanded. An expert medical psychologist will lead the focus group discussions. The interviews will be recorded, transcribed ‘verbatim’ and analyzed after each session. Items valuable to patients regarding their surgery and recovery will be discussed. This protocol will be published prior to the start of the Focus Group Discussion.

Discussion

Patients’ perspective on outcomes regarding their carotid surgery will be explored and tried to be identified. The results of the focus group discussions may fuel the ongoing global discussion on improving evidence based and patient reported outcome measures and will help the clinical physician to ‘understand’ their patients better. Focus group discussions may aid in the purpose of verification of PROs and PROMs.

Highlights

- Carotid surgery in general is only rarely evaluated by Patient Reported Outcome’s (PROs)

- Outcomes of carotid surgery are hardly verified from the patients’ perspective

- Focus group discussions may aid in the process of verification of patient reported outcomes (vPRO’s) to contribute to patient-centered-care

Introduction

Patients with significant carotid stenosis receive Best Medical Treatment (BMT), which includes antiplatelet therapy, antihypertensive medication if necessary, and lipid-lowering drugs. Carotid endarterectomy (CEA) is recommended as an option for symptomatic patients with significant internal carotid stenosis to prevent consecutive cerebral ischemic events or even death. However, CEA carries risks, including periprocedural stroke, bleeding, and death. ¹ These possible complications are frequently selected as primary outcomes in studies on carotid surgery or carotid interventions. ¹ Stroke and mortality are examples of ‘traditional’ outcomes. These complications can interact with the patients’ health related quality of life (QoL). The trend of using Patient Reported Outcomes (PROs) as ‘standard’ outcomes is seen in many healthcare intervention research projects. To measure PROs, several instruments are designed, the Patient Reported Outcome Measures (PROMs). PROMs provide a way to measure the impact of a disease and/or its associated treatment from the patients’ perspective. These PROMs can be generic, disease- or dimension specific.^2,3 At present, there are no PROMs known that are specific to carotid surgery. ⁴

An example of a generic PROM is the Short Form (SF)-36. This PROM is a set of generic, coherent, and easily administered health status measures. Instead of a generic questionnaire, a validated PROM for patients undergoing carotid surgery is necessary. The PROM can possibly provide data which can supplement traditional clinical outcomes, provide new insights regarding patient important outcomes, and these new insights can possibly assist doctors to inform patients better about the treatment decisions.

In previous research,^1,5,6 outcomes commonly used in carotid artery revascularization surgery were assessed from the physicians’ standpoint in terms of patients’ perspectives. Essentially, physicians might presume to understand patients’ perspectives. We will examine whether patients concur with the suggested hierarchy of outcomes and identify any additional outcomes that may be more pertinent to patients but remain undisclosed.

Not only evidence-based medicine is a crucial foundation for surgical interventions; however, it is also important to assess the clinical parameters that individual patients consider significant. Current available evidence is lacking specific PROMs for patients with a symptomatic and significant carotid stenosis and the carotid surgery (carotid endarterectomy).^2,7 The aim of this study is to examine individual patients and try to identify the patients’ perspective on carotid surgery using the eversion technique (ET) using focus group methodology. An exploratory focus group discussion (FGD) will be set up to identify items that concern the patients with carotid disease. PROs might thereby become verified from the patient’s perspective, to be called then verified PRO’s (vPRO’s). ⁸ These vPROs may contribute to enhancing the relevance and efficiency of future research on Carotid interventions; both open surgery as well as endovascular treatment.

Methods

Study Design

A focus group discussion (FGD) will be set up to identify items that concern the patients with carotid disease. FGD is a qualitative research method in which a group of people are asked about their perceptions, ideas and opinions regarding, in this case, the carotid surgery they underwent. Each focus group will consist of 6 to 8 patients (total of n = 24) with an inter-individual variety. The postoperative patients will be invited to join the focus group. The invited patients will engage in a semi-structured (predefined themes by the investigators) discussion about their experience regarding the carotid surgery they had. The moderator puts the participating patients at ease and creates an open and safe atmosphere. The participants are given the space to answer the questions in their own words and to explain the deeper meaning of their answers. Ideally, the discussion is pleasant and often the participants spontaneously like to talk about their ideas with each other. This gives the moderator the space to observe and where necessary to adjust back to the subject/theme. The themes will be presented using Microsoft PowerPoint during the FGD. Each slide will display one theme at a time. The purpose of the FGD is to obtain information from the patients regarding their perspectives on the course of their illness. Unlike a nominal group technique, the intention is not to achieve consensus regarding certain topics. The FGD will be recorded with a voice recorder and a transcription of the recording will be made. The FGD will be evaluated after each session. This evaluation with the moderator and main investigator will address several topics, including the time required for each theme, the number of questions that could be asked within this timeframe, and any new themes introduced by the patients. If no new information has been obtained, the research team will discuss whether data saturation has been achieved. This protocol is drafted in accordance with the SPIRIT guideline. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is a well-known guideline for the minimum content that should be included in a clinical trial protocol. ⁹

Participants and Recruitment

Patients presenting with an ischemic event will be evaluated by a neurologist. If there are indications of symptomatic carotid stenosis following additional examinations, the patient will be referred to a vascular surgeon, and their case will be discussed in a multidisciplinary meeting. Patients who have a symptomatic and significant (>50%) carotid stenosis and are eligible for carotid surgery using eversion technique (ET) in the Elisabeth TweeSteden Hospital, Tilburg, the Netherlands, will be asked to participate in this study. Patients’ participation will be discussed by the vascular surgeon (or lead investigator MM) when they visit the outpatient clinic or when they are hospitalized due to their ischemic event. Patients with symptomatic carotid stenosis who are not referred to the vascular surgeon after multidisciplinary consultation will be approached for participation by the neurologist (or lead investigator MM). We will explain the research we intend to conduct both verbal and in writing. The informed consent will be discussed and in addition a written consent will be obtained. Patients will be informed that participation will be voluntary and anonymous and that they could withdraw consent at any time without reprisal. ¹⁰

We intend to differentiate between the group that will undergo surgery and the group that will not undergo surgery. Both groups will be asked to complete a questionnaire on shared decision-making (SDM-Q-9 ⁸ ) and health status (SF-36 ⁹ ) in the preoperative phase. Validated Dutch versions of both questionnaires will be used. The healthcare providers will also be asked to complete the SDM-Q-9 (for healthcare providers). Additionally, all included patients will be asked to complete the (SF-36) questionnaire 3 months after their ischemic event and/or surgery.

The questionnaires will be provided via postal mail and email. If the researcher has not received a response 4 weeks after sending the questionnaire, the researcher will make a one-time phone call to the patient, requesting them to complete the questionnaire and return it in the provided return envelope or by email.

The patients who underwent surgery and are willing to participate in the focus group discussion will receive an invitation by letter and/or email after surgery. The date of the focus group discussion will be within 3 months after surgery. The 3-month interval is essential to ensure patients have fully recovered from surgery without having forgotten any relevant details in their treatment process; patients should be at least 3 weeks postoperative. Only adult patients with sufficient knowledge of the Dutch language (level A2 at least) will be included. Efforts will be made to gain a representative case mix, a selection will be made on age and gender since an appropriate inter-individual variety is recommended in a focus group. ¹¹ The consecutive order of including patients will probably result in a heterogeneous group. When necessary, a selection of patients can be made to create proper variety in each group. We will aim to include 6 to 8 patients in each focus group (total sample size of n = 24). ¹¹ In an attempt to balance both positive and negative experiences, complications will be no criterion for exclusion. The population invited for the study is potentially mobility impaired, and the convening of the focus group meeting could pose a significant burden. If this proves to be the case in practice, with insufficient patients willing or able to come to the hospital, we will provide the option to attend a session online using Microsoft Teams. Patients will be receiving no other financial compensation than a travel fee and/or free parking ticket and if possible, a 15€ gift card. Relatives and acquaintances of the patients will not attend the focus group discussion. They will be offered tea or coffee free of charge while waiting.

Outcomes

Primary

• Gain insight into the outcomes that patients undergoing carotid endarterectomy consider important (PROs).

Secondary

• Measuring by health status (SF-36 questionnaire pre- and 3 months postoperatively).

• Understanding the experience of shared decision-making (one-time SDM-Q-9, questionnaire for physician and patient).

Hypothesis

Our hypothesis posits that, in addition to the existing patient-related outcomes (such as stroke and mortality), there are other patient-related outcomes that are relevant to the patient but may not yet be adequately recognized by healthcare providers. This assumes there will be limited agreement between these outcomes. It is conceivable that the shared decision-making process may influence these outcomes.

In- and Exclusion Criteria for the Focus Group Discussions

Inclusion Criteria

• Patients (>18 years) who are eligible for unilateral ET for a symptomatic and significant (≥50%) stenosis of the internal carotid artery.

• Patients should be willing to participate in a focus group at a minimum of 3 weeks and at most 3 months after the procedure.

• Patients who are capable to read, write, and speak the Dutch language (At least level A2, ¹⁰ ).

• Patients with or without complications will be included.

Exclusion Criteria

• Previous carotid surgery (contralateral side).

• CAS.

• Previous head- and neck surgery.

• Previous radiotherapy in head- and neck region.

Focus Group Discussion

The focus group discussions will take place in a conference room inside the Elisabeth TweeSteden hospital. Each FGD will be scheduled for 120 min. Each FGD will include two 45-min sessions with a 20 min break in between. The moderator in this study will be a medical psychologist with considerable experience in focus group discussions (MH). The primary responsibilities of the moderator will be to pose open-ended questions to stimulate discussion during periods of silence and to ensure that all participants have the opportunity to express their opinions and feelings. Two investigators will be present during the focus group discussions for observation without participating or interrupting the conversation in any way.

Questions

The sessions will follow a predefined structure consisting of the: introduction of the moderator, rules, introduction of the patient, transition, pre-, peri- and postoperative phases (the key questions) and conclusion. During the sessions, an attempt will be made to guide the patient through the various phases of the disease process and elicit their opinion on each phase. The attached questionnaire serves as a guide for the discussions with the patient; not all questions need to be addressed during each session. Dutch version of the questions can be found in supplementary material 5.

Introduction of the Moderator

Rules

• The audio of these sessions will be recorded and some notes will be made.

• Only 1 person speaks at the time.

• Every given answer is correct, we are looking for your opinion and experience.

• You are not required to answer each question if you do not want to.

• This session is anonymous, no personal information will be used for publication.

• Are there any questions prior to the start of this session?

Introduction

• What is your name and age?

• How many weeks postoperative are you at this moment?

Preoperative Expectations

• What did you expect prior to the surgery regarding your admission duration, and recovery?

• Which elements of the expectation were true?

• Which elements of the expectation were false?

Information and Preparation

• What were for you, as a patient, important elements of the conversation with the doctor prior to the surgery?

• Was the information concerning benefits and risks of carotid surgery clear to you?

• Did you feel that you were involved in the decision-making process regarding the treatment options?

• Could you describe if there were any differences in the conversation with the (vascular) neurologist and the vascular surgeon?

• What was your assessment of the prescribed medication? Did you have any inquiries or concerns regarding it?

• What should be emphasized (more) regarding these important elements (for example alternatives, Medium- or Intensive care unit admission)?

• What information did you want to have prior to the surgery?

• Could you name any elements that were missing in the provided information regarding the admission in the hospital and hospital stay?

• What was your biggest concern regarding the upcoming surgery?

• How did you choose for the hospital/surgeon and surgical technique?

• Were any possible complications of the surgery discussed and if so, which possible complication was for you the most important one (stroke, death, others)?

• Did you get the opportunity to ask all relevant questions to the healthcare providers?

Day of the Surgery

• What was your most positive experience at the day of your surgery?

• What was the worst experience?

• How did you experience the care at the surgical ward when admitted?

Recovery

• Which, if any, drawback(s) did you experience and what was the most important?

• At which point did you feel recovered?

• What defined this point of recovery?

• What helped you in your recovery?

• Are there, after the moment of recovery, complains left?

• If a complication occurred, how did it effect you on your daily activities (eg, in case of a hypoglossal nerve palsy: Difficulty eating swallowing, drooling)?

• If you had known in advance that you would experience this complication, would you still have chosen to undergo the surgery?

• What do you think about the scar?

• On which aspect of your treatment should future patients be informed more extensive?

Postoperative Healthcare Experience

• What did you think of the provided healthcare after your surgery? Did it meet your expectations and needs? Did you feel heard?

• Prior to the surgery, complications were discussed in oral and written information. Which complication would have been the worst in your opinion?

• What should doctors emphasize (more) in the conversation prior to the surgery?

• Which aspect in the whole surgical experience should be told each time?

• Did you have any concerns regarding the costs of the duration of the hospital admission, surgery and the postoperative recovery phase?

• Were you overwhelmed by the rapidity of the healthcare providers’ actions?

• How did you experience the time between your stroke and the surgery?

Evaluation

• Did you miss any unaddressed topic(s)?

Data Collection and Analysis

Socio-demographic data (age, gender, occupation, and educational level) will be registered. Clinical data (date of surgery, type of surgery and if any complications occurred) will be taken from the electronic medical files. The responses from the questionnaires will be collected, and for the questions answered using a Likert scale(16), the means and ranges will be calculated. The discussions will be audiotaped and transcribed verbatim (word by word) to allow transparency in analysis by the main investigator. The output of the recordings will be saved in a Microsoft Word file. The full transcriptions will be searched for possible items by 2 authors independently. The pre-, peri- and postoperative phases will be used to form main themes. Furthermore, subcategories will be made. All quotes that answered to the study’s aim (answers to the questions within the themes) will be scored as items consisting of single words or short sentences. When remarks were highly equivalent, the same item description will be formulated. Disagreements will be solved by authors-discussion. Frequencies of the items will be considered as an indirect, proportional measure of ‘item importance,’ eg, if a certain item is mentioned by several individuals this will be interpreted as more important than a single notification. The research will be reported in line with the Consolidated criteria for reporting qualitative research (COREQ), ¹² a guideline for reporting qualitative research. The data will be stored on a securely shared drive of the hospital (ETZ) during the collection, processing, and analysis phases. This drive is accessible only within the hospital network and with personal login credentials. Access to the specific folder is restricted to authorized individuals. After completion of data analysis and publication of the study, the data will be stored in a compressed folder in the Tilburg University Dataverse repository (https://dataverse.nl/dataverse/tiu) for at least 10 years. The audio recordings are deleted after they have been transcribed.

Subgroup Analysis

Subgroup analyses are to date not prior focus of this exploratory study. However, when unexpected outcomes seem to unfold, then a discussion among the authors will take place if additional analysis should be conducted. If so, a clear consensus-and description of that process accompanied by the additional analyses-outcomes will be described in the definitive article as paragraph: ‘differences between protocol and definitive paper’.

Limitations of the Study Design and Possible Bias

The patients’ experiences will be explored. Various potential biases can be identified. ¹³ Considering that some patients are elderly and may not fully comprehend everything, there could be a so-called recall bias. When this bias is present, patients may under- or overreport their experiences.^14,15 The composition and size of the group may potentially influence the patients’ responses. A group predominantly consisting of individuals with the same educational background or socioeconomic status might overshadow a patient who falls outside of these categories. When the total sample size is too small, the results should possibly not be generalizable for the entire population (selection bias). ¹³ Therefore, we want to include a heterogenous group of 6-8 patients and repeat the focus group at least 3 times with the expectation of data saturation after 3 sessions. Patients who are enthusiastic about participating in the study might already have a positive outlook on their treatment, in contrast to patients who are more skeptical. Other bias such as being influenced to agree or say socially acceptable answers (response bias) ¹³ during the focus group or any fear that the patients’ treatment will be different when patients are not willing to participate in this research (selection bias).

Supplemental Material

Supplemental Material - Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy

Supplemental Material for Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy by M. S. Marsman, G. G. Koning, B. P. W. Jansen, M. M. P. J. Reijnen, M. Habibovic, and P. W. H. E. Vriens in Journal of Vascular and Endovascular Surgery.

Supplemental Material

Supplemental Material - Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy

Supplemental Material for Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy by M. S. Marsman, G. G. Koning, B. P. W. Jansen, M. M. P. J. Reijnen, M. Habibovic, and P. W. H. E. Vriens in Journal of Vascular and Endovascular Surgery.

Supplemental Material

Supplemental Material - Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy

Supplemental Material for Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy by M. S. Marsman, G. G. Koning, B. P. W. Jansen, M. M. P. J. Reijnen, M. Habibovic, and P. W. H. E. Vriens in Journal of Vascular and Endovascular Surgery.

Supplemental Material

Supplemental Material - Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy

Supplemental Material for Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy by M. S. Marsman, G. G. Koning, B. P. W. Jansen, M. M. P. J. Reijnen, M. Habibovic, and P. W. H. E. Vriens in Journal of Vascular and Endovascular Surgery.

Supplemental Material

Supplemental Material - Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy

Supplemental Material for Study Protocol for a Focus Group Discussion About the Patients’ Perspective on Carotid Endarterectomy by M. S. Marsman, G. G. Koning, B. P. W. Jansen, M. M. P. J. Reijnen, M. Habibovic, and P. W. H. E. Vriens in Journal of Vascular and Endovascular Surgery.