Exploring meningococcal serogroup B vaccination conversations under shared clinical decision-making in the US

Abstract

Objective

In 2019, the United States Advisory Committee on Immunization Practices (ACIP) updated their meningococcal serogroup B (MenB) vaccination recommendation for 16–‍23-year-olds from individual to shared clinical decision-making (SCDM). SCDM recommendations are individually based and informed by a decision process between patients and healthcare providers (HCPs). MenB vaccination among 16–23-year-olds remains low. We examined recorded conversations in which MenB vaccine-related discussions between HCPs and patients/caregivers took place, and how these interactions changed following the updated SCDM recommendation.

Methods

An analysis of recordings where MenB vaccination was discussed between HCPs and patients (16–‍23 years old)/caregivers was conducted using retrospective anonymized dialogue data (January 2015–October 2022). Shared decision-making strength was measured using a modified OPTION5 framework.

Results

Of 97 included recorded conversations, the average duration was 11.3 min. Within these conversations, MenB disease was discussed for 0.25 min (38.9% of words in total vaccine-preventable diseases discussion) and MenB vaccination was discussed for 1.36 min (60.9% of words in total vaccine discussion), on average. HCPs spoke 78.8% of MenB vaccine-related words and most (99.0%) initiated the MenB vaccination discussion. In 40.2% of recordings, HCPs acknowledged the MenB vaccine without providing a clear recommendation. HCP recommendations often favored MenB vaccination (87.0%) and recommendations were 21.4% stronger post-recommendation change to SCDM. As measured by the modified OPTION5 framework, most recordings did not reflect a high degree of shared decision-making between HCPs and patients/caregivers.

Conclusions

MenB vaccination discussions were brief, and the degree of shared decision-making was low. Targeted education of HCPs and patients/caregivers may improve MenB vaccination awareness, SCDM implementation, and vaccine uptake.

PLAIN LANGUAGE SUMMARY

Meningitis is a serious and sometimes deadly disease. In the United States (US), the Centers for Disease Control and Prevention (CDC) recommends that 16–23-year-olds get vaccinated against meningococcal serogroup B (MenB), which causes a specific type of meningitis called invasive meningococcal disease. As of 2019, the CDC recommends that healthcare providers and patients or their caregivers have a shared decision-making discussion about deciding to get vaccinated against MenB. Despite these recommendations, vaccination against MenB among 16–23-year-olds is very low. Only about 3 in 10 17-year-olds had received the MenB vaccine in 2022. We studied conversations between healthcare providers and patients or their caregivers that included discussions of MenB vaccination. These discussions were largely brief and led by the healthcare providers. We found that healthcare providers most often made recommendations that were in favor of their patients getting vaccinated against MenB. However, we also found that healthcare providers missed many opportunities to have these shared decision-making discussions about MenB vaccination with patients or their caregivers. Providing education and resources for patients, caregivers, and healthcare providers focused on increasing awareness about MenB vaccination and the role they can play in having shared decision-making discussions may lead to more adolescents and young adults getting vaccinated against MenB. More research is needed to find out how we can improve MenB vaccination coverage in the US.

Keywords:

• Meningococcal vaccines
• MenB
• adolescent
• health communication
• shared clinical decision-making
• ACIP

Introduction

Invasive meningococcal disease (IMD), caused by Neisseria meningitidis infection, is a life-threatening illness with a mortality rate of 10–15% even when treated^1,2. Up to 40% of IMD survivors may experience short- and long-term complications³. In the United States (US), IMD is primarily caused by 5 common serogroups (A, B, C, W, and Y). US adolescents and young adults 16–23 years old are at an increased risk for IMD, and meningococcal serogroup B (MenB) is the leading cause of the disease among these groups^4,5. In 2015, the US Advisory Committee on Immunization Practices (ACIP) first recommended MenB vaccination under individual clinical decision-making (Category B) for 16–23-year-olds⁶. In 2019 (published September 2020), the ACIP changed the Category B language to shared clinical decision-making (SCDM), which refers to an individually based vaccine recommendation informed by a shared decision-making process between healthcare providers (HCPs) and patients and/or caregivers⁷. SCDM might include discussion of the serious nature of meningococcal infections, low average number of MenB infections in the US, increased risk among college students living in close quarters, and protections offered by MenB vaccination⁷.

Despite the availability of vaccines, MenB vaccination coverage remains low. Based on the National Immunization Survey-Teen 2022 report, only 29.4% of 17-year-olds had received a MenB vaccine dose, compared with 60.8% who had received the routinely recommended two doses of a vaccine against meningococcal serogroup A, C, W, and Y (MenACWY)⁸. The routine health care visit provides an important opportunity for older adolescents to receive their recommended vaccines. However, HCPs’ and patients/caregivers’ knowledge gaps regarding MenB disease and vaccination, and poor awareness of ACIP recommendations under SCDM, might contribute to lower vaccination coverage^9–12. In light of the evidence that has accumulated over time regarding HCP, patient, and caregiver knowledge gaps on SCDM, as well as the ongoing revisions of the ACIP’s adolescent meningococcal vaccine schedule, there is a need for the comprehensive evaluation of MenB vaccination under SCDM.

This study aimed to understand the conversational dynamics and decision drivers regarding MenB vaccination, and how these interactions have evolved following changes to ACIP recommendation language, with a focus on learning how SCDM for MenB vaccination occurs in practice.

Methods

Study objectives

This was a novel analysis of recorded in-office HCP-patient/caregiver conversations where MenB vaccination was discussed. To quantify the time spent discussing a given topic related to MenB vaccination, examine the content of these discussions, and evaluate the application of an assessment tool designed to measure shared decision-making, study objectives were split into quantitative (QnO), qualitative (QlO), and exploratory (EO) objectives, respectively (Table 1). Study results are presented in order of the study objectives.

Table 1. Study objectives.

Quantitative objectives (QnO)
Objective	Variable
QnO1: To measure the amount of time spent discussing meningitis (as disease for MenB and/or MenACWY)	Time spent discussing meningitis, measured both in seconds and words Overall recorded conversation time, measured both in seconds and words Number of vaccines discussed or mentioned
QnO2: To measure the amount of time spent discussing MenB (as disease and vaccination)	Time spent discussing MenB Time spent discussing MenACWY booster (if happening) Overall recorded conversation time Number of vaccines discussed or mentioned
QnO3: To measure the amount of time spent discussing vaccine-preventable diseases in general (e.g. flu, COVID-19, Tdap, and including MenB and/or MenACWY)	Time spent discussing vaccine-preventable diseases in general (e.g. flu, COVID-19, Tdap, including MenB & MenACWY) Overall recorded conversation time Number of vaccines discussed or mentioned
Qualitative objectives (QlO)
Objective	Coding
QlO1: To evaluate the conversational context in which the topic of the MenB vaccine first enters the conversation	Inductive coding What was discussed when the topic of the MenB vaccine was first introduced to the conversation? E.g. reviewing patient vaccination record; back to school topics Who mentioned MenB vaccination first? E.g. patient, caregiver, or HCP What type of topic introduction type introduced the first mention of the MenB vaccine? E.g. questions, requests, or recommendation
QlO2: To evaluate patient/caregiver descriptions of their knowledge and/or attitudes towards meningitis and recommended vaccines	Inductive coding. Included possibility of knowledge and/or attitudes expressed, e.g. aware; aware, due to vaccination requirements; aware, due to prior vaccination; preference for vaccines; vaccine skepticism; negative attitude; and/or positive attitude.
QlO3: To evaluate questions and concerns patients/caregivers express around MenB vaccination	Inductive coding, e.g. logistical (when to get next dose); experiential (side effects); and/or cost.
QlO4: To evaluate HCP responses to patient/caregiver knowledge and attitudes toward meningitis and MenB vaccination	Inductive coding, e.g. support or affirmation; providing further education; providing corrective education; dismissal; empathizing; and/or disagreement.
QlO5: To evaluate HCP vaccine recommendation styles, strategies, and/or areas of focus when discussing MenB vaccines	Did the HCP make a recommendation? If so, characterize how they initiate it, e.g. presumptive* or participatory** (e.g. based on communication styles in Opel, 2013 [32]; see Table S3) Strength of recommendation, e.g. scale of −2, −1, 0, 1, 2 (adapted from Scherr, 2017 [31]; see Table S4) Inductive coding (areas of focus), e.g. protection, need, ease, risk, and/or appeal to requirement
QlO6: To evaluate expectations that HCPs set for patients/caregivers around MenB and its prevention via vaccination	Inductive coding, e.g. form or degree of protection/prevention; when/how to receive following dose; possible side effects; degree of protection; symptoms avoided; mortality avoided; basic (e.g. “It protects you against meningitis B”); cost-related; or no expectations set
QlO7: To evaluate expectations that patients/caregivers express around MenB and its prevention via vaccination	Inductive coding, e.g. avoiding risks associated with infection; meeting requirements (e.g. for school); cost-related; and/or side effects
QlO8: To evaluate factors associated with patient or caregiver (if/as they become apparent) agreeing with their child receiving or not the MenB vaccine	Inductive coding, e.g. Conversational factors, e.g. patient pushback; caregiver pushback; and/or HCP insistence Response variables adapted from Opel, 2013 [32]; see Table S3 Circumstantial factors, e.g. no shots available in the office; travel plans; timing around other vaccines; timing around other treatments; acute conditions (e.g. respiratory infection); and/or general preference not to vaccinate
QlO9: To evaluate, based on what the recorded speakers say, as available in the data, the role of other office staff as it pertains to the MenB vaccine, (e.g. HCP talking about a nurse administering the MenB vaccine)	Inductive coding, e.g. record-keeping; and/or administers vaccine
QlO10: To evaluate, as available in the data, the role of other office staff who may be present in the recorded conversation (in relation or not to MenB vaccination), such as nurses and medical assistants	Inductive coding, e.g. record-keeping; and/or administers vaccine; incidental; and/or external
Exploratory objective (EO)
Objective	Variables
EO: To validate the application of a modified version of the Observer OPTION5 framework to measure SCDM regarding MenB vaccination discussions.	Item 1: For the health issue/topic being discussed, the HCP draws attention to or confirms that prevention options exist or that the need for a decision exists. If the patient/caregiver rather than the HCP draws attention to the availability of options, the HCP responds by agreeing that the options need deliberation. Item 2: The HCP reassures the patient/caregiver or reaffirms that the HCP will support the patient/caregiver to become informed or deliberate about the options. If the patient/caregiver states that they have sought or obtained information prior to the encounter, the HCP supports such a deliberation process. Item 3: The HCP gives information or checks understanding about the options that are considered reasonable (this can include taking no action), to support the patient/caregiver in comparing alternatives. If the patient/caregiver requests clarification, the HCP supports the process. Item 4: The HCP makes an effort to elicit the patient/caregiver’s preferences in response to the options that have been described. If the patient/caregiver declares their preference(s), the HCP is supportive. Item 5: The HCP makes an effort to integrate the patient/caregiver’s elicited preferences as decisions are made. If the patient/caregiver indicates how best to integrate their preferences as decisions are made, the HCP makes an effort to do so.

Note: The exploratory objective’s variables were adapted from Observer OPTION5 (Appendix A).

* Presumptive: declaring the vaccine would be administered.

** Participatory: mentioning the vaccine exists without providing clear recommendation.

Abbreviations: EO, exploratory objective; flu, influenza; HCP, healthcare provider; MenB, meningococcal serogroup B; MenACWY, meningococcal serogroups A, C, W, and Y; QlO, qualitative objective; QnO, quantitative objective; SCDM, shared clinical decision-making; Tdap, tetanus/diphtheria/pertussis.

Study population and data source

Quantitative and qualitative analyses of recorded in-office conversations between HCPs and patients/caregivers were conducted using retrospective anonymized syndicated dialogue data from Verilogue. As of December 5, 2023, Verilogue’s database contains over 205,000 US-based HCP-patient/caregiver visit recordings and corresponding transcripts. Verilogue’s database has been used in past research on human papillomavirus (HPV) vaccination, informed decision-making, and communication about interventions, therapeutics, medical expenses, etc.^13–23. Recordings in Verilogue’s database are primarily from community-level practice settings. HCPs are given small, unobtrusive digital audio recording devices (or a smartphone app) to securely record and transmit conversations to Verilogue.

This study complied with all US patient confidentiality requirements, including the 1996 Health Insurance Portability and Accountability Act (HIPAA) regulations. Approval of this study was provided by the GSK Protocol Review Committee, which reviewed the protocol. No direct subject contact or primary collection of individual human subject data occurred for this study, and personal identifiable information was removed by the database provider prior to receipt by the study team (study results are in tabular form and aggregate analyses that omit subject identification). As all data used in the study are fully de-identified and did not involve the collection, use, or transmittal of individually identifiable data, this study is not human subjects research. Therefore, it was determined that no ethics committee or IRB approval was necessary (Appendix A).

HCPs participating in Verilogue’s recording collection receive a list of patient- or visit-type categories of interest, but are not told the recordings are being collected for any specific study/analysis. Recorded conversations from this study took place during normal office visits and included discussion of MenB vaccination for patients 16–23 years old; no HCPs, patients, or caregivers were instructed to discuss MenB or MenB vaccination.

Eligibility criteria

Recordings meeting the interaction and participant eligibility criteria were included. Interaction criteria included the recording taking place January 1, 2015–October 31, 2022 and containing at least one instance of a key term (meningitis; men b; menb; Bexsero®; Trumenba®; bacterial meningitis; meningitis b; meningococcal) or recording metadata indicating that patients received a MenB vaccine as a part of the visit. January 1, 2015 was selected as the study period’s start date to capture the approval of MenB-FHbp (Trumenba^®) in 2014. Participant criteria included patients being 16‍–‍23 years old at the recorded visit and consenting to being recorded or the caregiver consenting if patients were <18 years old at the visit, and the HCP being a self-reported pediatrician or primary care physician (PCP). The term PCP was inclusive of primary care physicians, family physicians, and internists.

Recordings were excluded if they did not contain discussion of MenB vaccination as a possibility for the patient (Appendix B).

Analytical approach

Measures

All objectives (QnO, QlO, and EO) were investigated and mapped to their corresponding variables in Table 1. Regarding the exploratory objective, prior clinical research led to the development of the OPTION5 framework, a questionnaire measuring five degrees of quality in the shared decision-making process (though not specifically for IMD vaccination)^24–27. The OPTION5 framework was modified to accommodate unique features of SCDM for MenB vaccination (Table S1), e.g. US HCPs may have been likely to stock only one of the two MenB vaccine options licensed at the time of this analysis, and may have had knowledge gaps regarding SCDM implementation for the MenB vaccine (see further details in Appendix C).

Analysis

Recordings were separated into two subsets: from January 1, 2015–September 25, 2020, and from September 26, 2020–October 31, 2022. September 25th, 2020 was the publication date of the ACIP language change to SCDM and thus was selected as the cut-off date to capture the potential impact of the change on MenB vaccination discussions.

Quantitative variables from each recording were measured and used to compute aggregate descriptive statistics with breakdowns along general variables. General study variables are listed in Table S2.

Inductive coding was used to identify qualitative outcomes, whereby unstructured data were used to create a coding system for the dataset. Codes were developed from themes and patterns that were identified in descriptive notes of the recordings^28–30. Comparative assessments of the frequency of certain behaviors across the included recordings were also conducted.

To measure vaccine recommendation strength, an adapted five-point Physician Recommendation Coding System (PhyReCS) was used, where scores of 2 and −2 indicated strong recommendation for and against vaccination, respectively (Table S3)³¹.

A coding system adapted from Opel, 2013, previously used to explore vaccination discussions between HCPs and parents of infants, was used to characterize discussion initiation formats in this study (Table S4)³².

Results

General characteristics

Based on eligibility criteria, 97 recordings were included, featuring 21 HCPs (pediatricians and PCPs) and 97 patients. Visits were primarily in-person (1/97 recordings was conducted via telehealth). HCPs in the recordings were primarily male (80.4%), and in pediatric specialties (84.5%). Most included patients were male (62.9%), White (72.2%), and had private insurance (89.7%). Most recordings (90.7%) took place in the South Atlantic (56.7%) or Middle Atlantic (34.0%) US Census regions. HCP and patient characteristics are summarized in Table S5.

Both HCPs and patients were present and spoke in all recordings, and at least one caregiver was present and spoke in most recordings (81.4%). Most recordings were about the first MenB vaccination series dose (80.4%). An average of 3.59 vaccines (including MenB) were discussed per recording, with MenACWY (80.4%), HPV (60.8%), and influenza (47.4%) being the most frequent (Table S6).

In most recordings (60.8%), patients either received the MenB vaccine during the visit or were likely to have received it that day. In the remaining recordings, patients either planned to receive the vaccine in the future (29.9%); may have received the vaccine the day of the visit, but it was unclear (5.2%); or declined the vaccine when offered or physicians discouraged vaccination receipt and patients accepted this advice (4.1%; Figure S1). In the 8.2% of recordings where MenB vaccination took place during the recording or between segments of the recording, administration was evenly split between HCPs and other office staff.

Time spent discussing meningitis, MenB, and vaccine-preventable diseases (QnO1–3)

The recorded time spent discussing meningitis (or IMD), MenB, and vaccine-preventable diseases (VPDs) was measured. The overall average recorded time per visit was 11.3 min; participants spoke for 10.0 min. In all instances where IMD came up in conversation, it emerged as part of the discussion around MenB vaccination. In the overall discussion of VPDs (average of 131 words), 51 words or 0.25 min were spent discussing MenB (38.9% of words in total VPD discussion). MenB disease discussion was dominated by HCPs (83.4% of the MenB disease discussion duration) over caregivers (10.0%) and patients (3.3%).

Participants often spoke about MenB and MenACWY vaccines as a set; differentiation occurred when describing the need for both vaccines and the different protections each offers. On average, MenB vaccination was discussed for 1.36 min (60.9% of words in total vaccine discussion). HCPs dominated MenB vaccine discussion (speaking an average of 78.8% of those words). Post-ACIP recommendation change, discussions regarding vaccination against all VPDs were 87.0% as long as those pre-change (442 words pre-change; 384 post-change). The proportion of overall discussion that was focused on MenB and MenACWY vaccination increased post-change.

Context in which MenB vaccination entered the conversation (QlO1)

The context in which the topic of MenB vaccination was introduced was examined (QlO1). Almost exclusively, HCPs introduced MenB vaccine (99.0%) and MenACWY booster dose (96.2%) topics. However, the conversational context of the introduction varied, with discussion of patients’ vaccine records, plans, timelines, and/or vaccination needs being the most common (MenB: 79.4%; MenACWY: 82.1%; Table S7). Though no particular topic introduction type was dominant in either vaccine’s introduction, differences arose in the topic introduction type used between the two vaccines (Table 2). HCPs more frequently introduced the MenB vaccine through “non-recommendation” presentations (statements acknowledging the vaccine but not explicitly recommending it; MenB: 40.2%; MenACWY: 12.8%), while MenACWY vaccines were more frequently introduced by referencing the patients’ vaccination status (MenB: 6.2%; MenACWY: 39.7%). Statements that clearly recommended the MenB vaccine (classified as “imperatives”) accounted for approximately one-third of HCP introductions (MenB: 38.1%, MenACWY: 33.3%). There was a 43.3% increase in “imperative” and a 24.9% decrease in “non-recommendation” topic introduction types for MenB vaccination post-ACIP recommendation change (Table 2), with no major differences observed in the context of vaccine introduction (Table S7).

Table 2. Topic introduction type introducing the first mention of the MenB/MenACWY vaccine.

Topic introduction type	Topic introduction type introducing the first mention of the MenB/MenACWY vaccine, when HCP introduces				Topic introduction type introducing the first mention of the MenB vaccine, when HCP introduces: pre-/post-change
	MenB		MenACWY		Pre-change		Post-change
	n	%	n	%	n	%	n	%
Total Recordings	97	100.0	78	100.0	70	100.0	27	100.00
Non-recommendation presentation*	39	40.2	10	12.8	33	47.1	6	22.2
Informing of vaccine status	6	6.2	31	39.7	6	8.6	0	0.0
Imperative**	37	38.1	26	33.3	19	27.1	18	70.4
Declarative***	14	14.4	8	10.3	11	15.7	3	11.1
Not observed/not HCP	1	1.0	3	3.8	1	1.4	0	0.0

* Non-recommendation presentation: statements acknowledging the vaccine but not explicitly recommending it.

** Imperative: statements that clearly recommended the vaccine.

*** Declarative: statements describing vaccination as something that is happening or as what the HCP will do or wants to do.

Abbreviations: MenB, meningococcal serogroup B; MenACWY: meningococcal serogroups A, C, W, and Y; HCP: healthcare provider; post-change, post-ACIP recommendation change; pre-change, pre-ACIP recommendation change.

Patient/caregiver knowledge and attitudes regarding meningitis disease and vaccination (QlO2–3)

Patient and caregiver statements reflecting knowledge and/or attitudes towards meningitis disease or vaccination (e.g. feeling that meningitis is bad and/or intention to vaccinate at a later date) were infrequent. Questions or concerns regarding MenB/MenACWY (“meningitis”) vaccination were also infrequent, sample-wide, and occurred in similar patterns (Table S8). Few differences post-ACIP recommendation change were identified.

HCP responses to patient/caregiver knowledge and attitudes regarding meningitis disease and vaccination (QlO4)

Each occurrence of a patient’s or caregiver’s expression of MenB/MenACWY vaccine knowledge, attitudes, questions, or concerns statement was considered an opportunity for HCP response; of the 97 included recordings, 48.5% of MenB vaccination conversations had at least one such opportunity. HCP response types tended to be similar across certain question types. Rather than use these opportunities to have a shared decision-making MenB vaccination discussion, HCPs met “echo questions” (questions seeking to confirm or clarify what the HCP had just stated) from patients and caregivers with responses that briefly validated, clarified, or provided additional information to address those questions. Patient/caregiver concerns about pain associated with MenB vaccination were often minimized by HCPs and framed in the context of the patent’s prior vaccination experiences (Table 3).

Table 3. HCP response frequencies by prompt type (MenB context).

Prompt type		Affirmation/ support		Clarity/brief, factual answer/confirm		Educate		Compare to shots in general, prior received shots; downplay SAEs		Opens consideration/discussion		Response/acknowledgment not observed
Prompt Type	n	n	%	n	%	n	%	n	%	n	%	n	%
Aware from television	2	2	100.0	0	0.0	0	0.0	0	0.0	0	0.0	0	0.0
Meningitis is bad	1	1	100.0	0	0.0	0	0.0	0	0.0	0	0.0	0	0.0
Desire to receive vaccine	3	1	33.3	0	0.0	0	0.0	0	0.0	1	33.3	1	33.3
Someone else (received or recommended)	3	1	33.3	0	0.0	0	0.0	0	0.0	1	33.3	1	33.3
Wants to confer with caregivers/others	3	3	100.0	0	0.0	0	0.0	0	0.0	0	0.0	0	0.0
Intends to wait	3	3	100.0	0	0.0	0	0.0	0	0.0	0	0.0	0	0.0
Echo question	14	0	0.0	14	100.0	0	0.0	0	0.0	0	0.0	0	0.0
Am I receiving this now/today?	4	0	0.0	4	100.0	0	0.0	0	0.0	0	0.0	0	0.0
Pain (side effect or needle)	8	0	0.0	0	0.0	0	0.0	8	100.0	0	0.0	0	0.0
Side effects, general	3	0	0.0	0	0.0	0	0.0	3	100.0	0	0.0	0	0.0
Prior receipt (patient or someone else)	5	0	0.0	4	80.0	0	0.0	0	0.0	0	0.0	1	20.0
Vaccine identity	4	0	0.0	4	100.0	0	0.0	0	0.0	0	0.0	0	0.0
Availability	3	0	0.0	3	100.0	0	0.0	0	0.0	0	0.0	0	0.0
Duration/kind of protection	2	0	0.0	0	0.0	1	50.0	0	0.0	0	0.0	1	50.0
Requirements/school	4	0	0.0	4	100.0	0	0.0	0	0.0	0	0.0	0	0.0
Dosage	3	0	0.0	2	66.7	1	33.3	0	0.0	0	0.0	0	0.0
General resistance	1	0	0.0	0	0.0	0	0.0	0	0.0	0	0.0	1	100.0
Vaccine: MenB vs. MenACWY	6	0	0.0	1	16.7	5	83.3	0	0.0	0	0.0	0	0.0
Should I/they receive? Okay to receive?	2	0	0.0	0	0.0	1	50.0	0	0.0	1	50.0	0	0.0
Symptoms?	2	0	0.0	0	0.0	2	100.0	0	0.0	0	0.0	0	0.0
What is it?	3	0	0.0	1	33.3	2	66.7	0	0.0	0	0.0	0	0.0
How do I get it?	3	0	0.0	0	0.0	3	100.0	0	0.0	0	0.0	0	0.0

Abbreviations: MenB: meningococcal serogroup B; MenACWY: meningococcal serogroups A, C, W, and Y; SAEs: spontaneous adverse events.

HCP vaccine recommendation styles, strategies, and/or areas of focus when discussing MenB vaccines (QlO5)

Of 92/97 recordings in which MenB vaccination was discussed in a way that it could receive an adapted PhyReCS score, HCP recommendations tended to favor vaccination (87.0%), with neutral recommendations (9.8%) occurring more frequently than recommendations against vaccination (3.4%; Table 4). Of 54/78 recordings in which MenACWY vaccination discussion could receive an adapted PhyReCS score, overall mean recommendation strength for MenACWY vaccination (1.7) was slightly stronger than for MenB vaccination (1.5), with no recommendations against vaccination, though both reflected mild to strong vaccination recommendation.

Table 4. Frequency of adapted Scherr, 2017 scores, MenB and MenACWY vaccination.

MenB vaccination			MenB vaccination pre-change		MenB vaccination post-change
Adapted Scherr recommendation strength score	n	%	n	%	n	%
Total Recordings	92	100.0	66	100.0	26	100.0
Strong against	2	2.3	2	3.0	0	0.0
Mild against	1	1.1	1	1.5	0	0.0
Neutral	9	9.8	7	10.6	2	7.7
Mild for	16	17.4	12	18.2	4	15.4
Strong for	64	69.6	44	66.7	20	76.9
MenACWY vaccination			MenACWY vaccination pre-change		MenACWY vaccination post-change
Adapted Scherr recommendation strength score	n	%	n	%	n	%
Total Recordings	54	100.0	37	100.0	17	100.0
Strong against	0	0.0	0	0.0	0	0.0
Mild against	0	0.0	0	0.0	0	0.0
Neutral	3	5.6	2	5.4	1	5.9
Mild for	9	16.7	6	16.2	3	17.6
Strong for	42	77.8	29	78.4	13	76.5

Note: Of 97 recordings in which MenB vaccination discussion took place, MenB vaccination was discussed in a way that it could receive an adapted PhyReCS score in 92 recordings. Of 78 recordings in which MenACWY vaccination discussion took place, MenACWY vaccination was discussed in a way that it could receive an adapted PhyReCS score in 54 recordings.

Abbreviations: MenB: meningococcal serogroup B; MenACWY: meningococcal serogroups A, C, W, and Y; post-change, post-ACIP recommendation change; pre-change, pre-ACIP recommendation change.

Mean MenB vaccination recommendation scores became 21.4% stronger post-ACIP recommendation change (1.4 to 1.7), indicating stronger recommendations overall post-change. Mean MenACWY vaccination recommendation scores showed minimal change between the two periods. According to the adapted Opel coding system, HCPs used “presumptive” (declaring the vaccine would be administered) and “participatory” (mentioning the vaccine exists without providing clear recommendation) initiation formats for both MenB and MenACWY vaccines at similar proportions across the two time periods. Participatory initiation formats were observed to increase post-ACIP recommendation change (Table 5).

Table 5. Frequency of adapted Opel, 2013 initiation formats, MenB and MenACWY vaccination.

Adapted Opel initiation format	MenB		MenACWY
	n	%	n	%
Total eligible	71	100.0	40	100.0
Presumptive*	54	76.1	32	80.0
Participatory**	17	23.9	8	20.0
Adapted Opel initiation format	Pre-change
	n	%	n	%
Total eligible	48	100.0	28	100.0
Presumptive*	39	81.3	24	85.7
Participatory**	9	18.8	4	14.3
Adapted Opel initiation format	Post-change
	n	%	n	%
Total eligible	23	100.0	12	100.0
Presumptive	15	65.2	8	66.7
Participatory	8	34.8	4	33.3

* Presumptive: declaring the vaccine would be administered.

** Participatory: mentioning the vaccine exists without providing clear recommendation.

Abbreviations: MenB, meningococcal serogroup B; MenACWY, meningococcal serogroups A, C, W, and Y; post-change, post-ACIP recommendation change; pre-change, pre-ACIP recommendation change.

HCP recommendation styles, strategies, and focus areas regarding MenB vaccination (QlO5–8)

Recordings were coded for the presence or absence of 17 focus areas, topics, or themes relevant to the MenB vaccination discussion based on whether they increased, decreased, or had no effect on patients’ likelihood of MenB vaccination receipt. Vaccine safety and completionism (i.e. series completion; or the appeal of finishing what one has started) were associated with the highest rates of vaccine receipt (76.7% and 73.8%, respectively; Table S9).

Factors associated with decision to receive the MenB vaccine (QlO8)

Factors associated with patients or caregivers (on their child’s behalf) agreeing to receive or not receive a MenB vaccine were also evaluated. For both MenB and MenACWY vaccines, presumptive initiation formats tended to be met with vaccine acceptance, while participatory initiation formats (although less frequent) were often met with resistance (Table S10). Differences pre- and post-ACIP recommendation change suggested an increase in the amount of MenB vaccine resistance in response to presumptive formats, while this was less clear for the MenACWY vaccine (Table S11).

Role of other office staff in MenB vaccination discussions (QlO9–10)

The role of other office staff, such as nurses and medical assistants, as it pertained to vaccination, based on what recorded speakers said about them during the recordings, was examined. Roles fell into two themes: vaccine administration (MenB: 21.6%; MenACWY: 11.3%) and vaccine record-keeping (MenB: 5.2%; MenACWY: 5.2%). No differences were observed between MenB and MenACWY or pre- and post-ACIP recommendation change. Less than a quarter of recordings captured at least one other office staff member speaking (21.6%). In 57.1% of these recordings, present office staff spoke few words and contributed little that was relevant to the MenB vaccination discussion.

Application of the modified OPTION5 framework (EO)

A modified version of the OPTION5 framework was applied to measure shared decision-making regarding MenB vaccination discussions. Most recordings (62/97) received a 0/5 score (mean score of 0.68), indicating no observed shared decision-making. Incrementally stronger overall scores were observed with decreasing frequency (Table S12). Item 1 (HCP draws attention to existing options or need for a decision) and Item 3 (HCP supports comparison of alternatives, offers, or affirms information) were the most often observed across recordings. Synthesis of recommendation strength, initiation format, and modified OPTION5 scores suggested a correlative relationship between recommendation strength, initiation format, and shared decision-making. While both initiation formats were consistently associated with recommendation scores favoring MenB vaccination, participatory initiation formats were associated with both higher shared decision-making and weaker recommendations. When serialized by year, modified OPTION5 scores for participatory initiation formats were found to decrease (2016: 0.40; 2019: 0.30) before increasing again in 2022 (0.44), whereas modified OPTION5 scores for presumptive initiation formats were found to generally decrease by year (2016: 0.08; 2019: 0.07; 2022: 0.02) (Table S13).

Discussion

This study aimed to understand the decision drivers and conversational dynamics between HCPs and patients or their caregivers regarding MenB vaccination under SCDM. Overall, discussions of MenB vaccination were brief and HCP-dominated, indicating that these discussions are currently enacted as short, largely HCP-driven interactions.

The majority of MenB and MenACWY vaccine discussions were initiated by HCPs, which aligns with findings from two 2023 studies, in which physicians (pediatricians, family physicians, general practitioners, and internists), nurse practitioners, and physician assistants reported initiating conversations on MenB vaccination in 79%, 71%, and 67% of cases, respectively^11,12. Though both vaccines were introduced in similar conversational contexts, HCPs frequently framed MenB vaccination with objective statements or introduced it as necessary, while framing MenACWY vaccination in the context of past vaccination experiences. As reported in a 2018 study, among providers who always or often initiated a MenB vaccination discussion with 16–18 year old patients, 91% recommended the MenB vaccine, aligning with our findings that HCPs (a majority of whom initiated the MenB vaccination discussion), also tended to use language favoring MenB vaccination in their conversations¹⁰.

Furthermore, use of the adapted PhyReCS system identified strong recommendation scores for both MenB and MenACWY vaccination. While recommendation strength for MenACWY remained constant, recommendation strength for MenB vaccination increased post-ACIP recommendation change (potentially to anticipate nuances around its nature as a non-routine recommendation). Differences in HCP adherence to MenB versus MenACWY vaccine recommendations may reflect uncertainty around how each recommendation should be implemented in practice. Previous studies have found that the existence of two distinct recommendation types (SCDM versus routine) for two vaccines that prevent against the same disease (IMD) has generated confusion among HCPs, patients, and caregivers; many remain unaware of the different protections offered by each vaccine^33,34.

Additional differences in MenB vaccination conversations pre- and post-ACIP recommendation change to SCDM were also observed. In this study, HCPs more frequently used neutral language to introduce the MenB vaccine pre-ACIP recommendation change (47.1%) and statements framing it as necessary post-change (70.4%). Furthermore, post-change, discussions regarding vaccination against all VPDs (including MenB) were shorter, more statements clearly recommending MenB vaccination were used by HCPs, and MenB vaccine recommendations by HCPs were stronger. However, these stronger recommendations did not reflect adequate adherence to SCDM and conflict with the nature of shared decision-making. The ensuing confusion among HCPs following the ACIP’s updates to MenB recommendations has been well-documented in the literature^9,10. Among physicians in a 2023 study, 54% did not correctly identify SCDM recommendations for MenB vaccination³⁴, substantiating the likelihood of persistent HCP uncertainty regarding SCDM implementation for MenB vaccination.

While infrequent, patients’ and caregivers’ expressed questions and concerns were more varied and frequent than expressed knowledge and attitudes. HCP responses to echo questions on meningitis disease and vaccines largely missed the opportunity to use SCDM; rather, responses provided brief education and mitigated patient and/or caregiver concerns. SCDM discussions might cover the serious nature of IMD, groups at higher risk for infection, and protections offered by MenB vaccination⁷. A 2023 study found that only 35–45% of MenB-vaccinated cohorts (patients and parents) were aware of SCDM, suggesting that many HCPs are missing opportunities to implement SCDM as it pertains to MenB vaccination³⁵.

Although HCPs most commonly used presumptive initiation formats across the two time periods per the adapted Opel coding system, the proportion of participatory initiation formats increased post-change for both MenB and MenACWY vaccines. Recordings where HCPs declared the MenB vaccine would be administered (presumptive initiation formats) tended to frame MenB vaccination as necessary and received strong recommendation scores. A decrease in these presumptive initiation formats would presumably correlate with a decrease in average recommendation strength. However, our findings indicated the opposite (i.e. average recommendation strength increased), suggesting that HCPs can communicate that they strongly favor MenB vaccination while still creating space for patients and caregivers to participate in decision-making. A 2023 study found that strongly recommending the MenB vaccine was vaccinators’ top-suggested approach (77%) for improving MenB vaccination rates¹¹. In line with our findings, this suggests that when HCPs are recommending the MenB vaccine to patients, many may be using approaches that contradict the “shared” aspect of SCDM.

Overall, recordings where HCPs declared the MenB vaccine would be administered (presumptive initiation formats) had stronger recommendation scores, but lower SCDM values. The opposite occurred for recordings with more collaborative discussions (where participatory initiation formats were used), reflecting the potential for tension between SCDM and recommendation strength. This highlights the need for providing guidance to HCPs on how SCDM can be achieved, while still allowing HCPs to communicate that they recommend MenB vaccination. Previous studies have found that a high number of MenB vaccinators have received training or educational materials on SCDM implementation (up to 78% of MenB vaccinators in a 2023 study, where 51% reported self-training using published or posted guidelines)³⁴. However, persistent knowledge gaps among HCPs substantiate the need for recommendations that consider the barriers these gaps can pose to vaccination access, in order to improve coverage rates^35,36. Future recommendations for meningococcal vaccines should consider how barriers resulting from knowledge gaps around SCDM could affect vaccination access.

Although the increased proportion of participatory initiation formats post-ACIP recommendation change was linked to an increase in SCDM, other factors must be considered. Items 1 (making patients aware of their options) and 3 (educating on options) of a modified OPTION5 framework contributed the most to modified OPTION5 scores; however, these items were possibly more easily observed or often enacted by HCPs. These items could partially account for the parallel increase in proportion of participatory initiation formats and SCDM, suggesting a potential for improving the applicability of modified OPTION5 to measure SCDM.

Prior studies have indicated improved patient-reported outcomes and improvements to the HCP-patient relationship due to shared decision-making between HCPs and patients or their caregivers^37,38. Hence, improving the applicability of currently available tools to measure SCDM could potentially improve the implementation of SCDM for MenB vaccine recommendations and other disease areas as well. The ACIP has four other recommendations for vaccination under SCDM that appear on the immunization schedules (i.e. vaccination against respiratory syncytial virus for adults ≥60 years old, hepatitis B for adults ≥60 years old with diabetes mellitus, HPV for 27–45-year-olds, and pneumococcal conjugate vaccination for adults ≥65 years old who have completed the recommended vaccine series)³⁹. As suggested by our study within the context of MenB vaccination, increased awareness of current SCDM recommendations among HCPs and patients could potentially help improve the implementation of SCDM for other vaccine-related consultations. Future research could apply similar methodologies to those used in this study to investigate how SCDM is implemented for other vaccines in practice.

Furthermore, while highlighting the potential to improve currently available tools for measuring SCDM, the recordings examined in this study also help demonstrate the validity of using evaluation tools with fewer levels of gradation, (such as the modified OPTION5 framework) given that shared decision-making discussions were short and not framed as high-priority by HCPs. Finally, COVID-19 pandemic-related changes in vaccine hesitancy and the smaller subset of recordings post-change may also have contributed to the increased proportion of participatory initiation formats and SCDM. Patient and caregiver opposition to vaccination increased, possibly reflecting a correlative relationship or the increased prevalence of vaccine hesitancy during the COVID-19 pandemic⁴⁰.

Limitations

In Verilogue’s collection process, HCPs recruitment may have prioritized high-prescribers and community settings, and HCPs might have chosen to record visits based on the discrete patient- or visit-type categories requested (though no guidance given to HCPs included MenB). However, as generalization to the US was not the main intention of the study, these limitations likely had a minimal effect on results interpretation. Exhaustive measurements of time spent discussing a topic could not be automated and thus were subject to possible human error. However, this study employed linguists and social scientists trained to conduct rigorous analysis of unstructured, real-world data to mitigate these effects and preserve reliability.

While this study presents novel research highlighting an analysis of recorded in-office conversations, the limited number of recordings analyzed, as well as the period of time during which this study was conducted, were limitations. Partial study coincidence with the COVID-19 pandemic may have caused unforeseen effects on healthcare interactions. In addition, this study separated the sample into subsets to capture the publication of ACIP guidelines (September 2020), though it is possible there was a lag in SCDM adoption, as behavior change may not have happened immediately after publication.

Furthermore, the sample selection of this study was also limited. While nurse practitioners and physician assistants are also MenB vaccinators, no recordings were submitted by these groups. Future research should examine the role of other office staff in adolescent meningococcal vaccination.

Educational campaigns/tools present a key opportunity to increase awareness about MenB recommendations. The CDC guidelines and educational materials developed for HCP use exist, but their implementation in practice requires further evaluation^41,42. While this study was not designed to assess the utility or success of available educational tools during healthcare visits, recordings from this study could be further examined to assess the use (or lack thereof) of such educational tools during visits. Broader research leveraging the type of data used in this study (i.e. audio-recorded HCP-patient/caregiver conversations) should be conducted to assess the use of educational resources to support the implementation of MenB vaccine recommendations under SCDM.

Conclusions

Our study found that MenB vaccination discussions were brief and HCP-driven, and had many instances for missed opportunities to enact the “shared” intent behind MenB SCDM recommendations. Patients and caregivers may benefit from targeted educational campaigns to increase awareness about their role in SCDM, while HCP education focused on best practical implementations of SCDM may improve MenB vaccination awareness and uptake. Broader national research is needed to improve our understanding of the conversational dynamics in which MenB vaccine discussions take place to understand the qualities that lead to improved MenB vaccination coverage.

Transparency

Author contributions

Substantial contributions to study conception and design: OHR, DEC, ZNH; substantial contributions to analysis and interpretation of the data: OHR, DEC, ZNH, CM; drafting the article or revising it critically for important intellectual content: OHR, DEC, ZNH, CM; final approval of the version of the article to be published: OHR, DEC, ZNH, CM.

Acknowledgements

The authors acknowledge Seongbin Shin, GSK, USA, for publication management. The authors also thank Costello Medical for editorial assistance and publication coordination, on behalf of GSK, and acknowledge Océane Parker, Costello Medical, Boston, USA, for medical writing and editorial assistance based on authors’ input and direction.

Declaration of financial/other relationships

OHR and DEC are employees and stockholders of GSK. ZNH is an employee of Verilogue. CM is a current employee of Ithaka S + R, was an employee of Verilogue at the time of the study, and was previously contracted with Utah Tech University and the Coalition for Responsible Home Education. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability statement

The aggregate dataset generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.

Additional information

Funding

This study was sponsored by GSK (Study identifier eTrack VEO-000488). Support for third-party writing assistance for this article was funded by GSK in accordance with Good Publication Practice (GPP 2022) guidelines (https://www.ismpp.org/gpp-2022).