A crossed-disciplinary evaluation of parental perceptions surrounding pediatric non-invasive brain stimulation research

Abstract

Purpose –

Recruitment for pediatric non-invasive brain stimulation (NIBS) studies is often challenged by low enrollment. Understanding parental perceptions regarding NIBS is crucial to develop new communication strategies to increase enrollment.

Design/methodology/approach –

Integrating a crossed-disciplinary approach, the authors conducted a survey at the 2018 Minnesota State Fair querying the perception of risk and preferences of current and future parents associated with pediatric NIBS research. The survey consisted of 28 closed-text questions including demographics, photographs portraying NIBS, terminologies and factors related to NIBS studies.

Findings –

Complete surveys were analyzed from 622 parent participants. A significant number of participants (42.8%) perceived the photographs of NIBS as “risky.” Additionally, 65.43% perceived the term “Non-invasive brain therapy” as not risky, a word combination not currently being used when recruiting potential participants. Over 90% (561/622) of participants chose the photograph of child-friendly MRI suite.

Research limitations/implications –

Although this survey identified aspects crucial in recruitment for pediatric NIBS research, there were limitations. For example, the authors did not record the sex or demographic distribution (e.g. rural versus urban setting) of the participants. These factors may also influence recruitment messaging.

Originality/value –

For important medical research to impact and improve the lives of the potential remedies, participation by the public in clinical trials is necessary. Often the general public perceives the trials as risky as a result of poor marketing communication recruitment material. This study sought to be understood if how the message is encoded has an impact on the decoding by the receiver.

Introduction

Advancements in care for populations with neurologic diagnoses often stem from clinical research that is perceived as invasive or high-risk. Therefore, the success of recruitment, enrollment and retention (RER) for clinical research depends directly on the willingness of individuals to participate in clinical research. In pediatric research, parents or caregivers play a central role in RER of their children. Identifying variables that influence parents’ decisions to enroll children in research is paramount to furthering scientific advancements in pediatrics (Tait et al., 2003). Using proven marketing techniques regarding how information is communicated to the key decision makers (caregivers) may prove important in RER of pediatric research (Rowe et al., 2002). Therefore, as primary decision-makers or “consumers,” recruitment strategies tailored to parents’ comfort and understanding are important factors to improving RER rates, particularly when the consumer has little understanding of the vernacular used when evaluating alternatives in the decision-making process relative to health-care research and/or clinical trials. Specifically, it is important to determine how the recruitment material is developed (encoded) and correspondently interpreted (decoded) by the target market (parents/caregivers), as this can have a significant impact on the markets’ perception and therefore decision-making.

New technologies such as non-invasive brain stimulation (NIBS) have shown clinical effectiveness and improvement of symptoms in adults with neurologic injury (George et al., 2013; Boggio et al., 2010; Dionisio et al., 2018). Information about the effects of this technology in children with neurological diagnoses remains limited in part due to small sample sizes and heterogeneous studies (Rich et al., 2018). Ineffective communication with general public regarding the safety and efficacy of pediatric NIBS research in marketing recruitment may be a reason the techniques are considered high-risk by parents of children with neurologic diagnoses. Additionally, scientific community-based development of promotional materials used to recruit participants often does not focus on the level of understanding of the target population. This in turn exacerbates the inherent fear and leads to avoidance of research, limiting new discoveries and potential improvements in health outcomes. In both adult and pediatric neurologic populations, NIBS has been found to be safe, with few side effects (Dionisio et al., 2018; Gillick et al., 2015; Krishnan et al., 2015; Finisguerra et al., 2019). Based on these safety outcomes and feasible protocols, pediatric NIBS research has not been found to be of “high-risk” and may actually augment the effects of rehabilitation techniques and improve functional outcomes in pediatric neurologic disorders. However, low participation rates in NIBS research may be the result of negative perceptions of the procedure based on how it is communicated to the recruitment pool, e.g. parents of pediatric participants. However, no prior studies were conducted to understand parental perceptions regarding NIBS.

Using a cross-disciplinary approach incorporating neuroscience and marketing, previous work demonstrates the manner in which a recruitment message is encoded by the research team and subsequently decoded by participants can impact research participation (Paço et al., 2015). There is a large body of literature supporting the efficacy of how information is communicated to a particular market (Hansen, 2005; Meyers-Levy and Tybout, 1997; Zakia, 1987; Parasuraman et al., 1988; Cacioppo and Petty, 1984). Specifically, there is a significant association between symbol (words, graphics and colors) interpretation and decision-making by the receiver (Mick, 1986). As individuals seek efficient means of problem solving, they often rely on associations interpreted from marketing communications to make a decision that seeks beneficial interventions and avoids pain (Mowen, 1988). In the case of the consumption of health care and related services, how marketing communications are created and disseminated is particularly of concern as the consumers’ field of reference is often limited (Delbaere and Willis, 2015).

Although safe, NIBS has not yet been established as a treatment modality for certain neurologic condition such as cerebral palsy. Greater involvement of research participants is required to formulate robust conclusions regarding the potentials of NIBS. Despite mentioning safety information in the recruitment materials, we have observed challenges in recruiting for pediatric NIBS studies. In these studies, incorporation of both typically developing children (TDC) and children with disabilities (CWD) is equally important to perform optimal comparison of study results (Cole et al., 2018). Parents of a CWD may have unique perspective toward involving their CWD in research with the expectation for the child to have a better quality of life, and parental education level may also play an important role in decision-making. Earlier research has shown that higher parental education level has influenced parental behaviour towards certain pediatric medical conditions (Tai et al., 2017). For these reasons, we aimed to identify perceptions and preferences of the general population, particularly of parents across different education levels, regarding study design, terminology and environment in addition to perceptions of safety related to pediatric NIBS research. We hypothesized that parents have inaccurate perceptions surrounding the risk level and efficacy of NIBS research, and that parents with higher education levels and CWD would state they would be more likely to enroll their children in NIBS research.

To engage with the community and understand parental perceptions in pediatric NIBS research RER, we conducted a large-scale sampling in a public setting at the 2018 Minnesota State Fair, which is one of the most attended fairs in the USA, averaging an attendance of 200,000 people each day and 2,000,000 total attendance during the 12-day event (www.mnstatefair.org/about-the-fair/attendance/). The attendees of the fair represent a cross section of Minnesota population from many backgrounds. Conducting the survey at the Minnesota State Fair served as a unique opportunity to understand the perception of a representative sample of general population regarding pediatric NIBS. A formal University of Minnesota research facility on the state fairgrounds links the academic university with this large body of potential research participants by offering numerous human research opportunities within a single building (D2D.umn.edu). The manner in which NIBS research recruitment marketing is communicated to the parents and caregivers through marketing messages (collateral) might influence their decision to participate. Information obtained from this survey may guide future NIBS study design to improve parental understanding and achieve greater pediatric participation.

Methods

Study design

We conducted a short survey using a convenience sample from the 2018 Minnesota State Fair. In this cross-sectional study, 28 closed-text questions were developed by experts in Rehabilitation Medicine, Marketing and Neurosciences. The survey was intended to take participants 10–15 min to complete. As a measure of face and content validity during questionnaire development, the final draft was reviewed for feedback by 12 mock participants not familiar with NIBS, half of whom were parents, and half of whom planned to become parents in the future. The majority of mock participants did not have concerns regarding the construct and level of understanding of the survey. However, one mock participant mentioned that one manner of wording describing NIBS techniques was difficult to understand (e.g. non-surgical brain activation). The feedback was then integrated to produce the final survey presented herein (e.g. “focused brain activation”). The survey was conducted in the research building located near the agricultural building at the Minnesota State Fair grounds. The research building has a research space of over 2,500 square feet that can accommodate up to ten studies at a time. The building has abundance of natural light and equipped with seating and iPads for the participants in addition to provision of highspeed Wi-Fi and hard-wired internet. Participants were verbally screened by a member of the research team to determine eligibility, which is detailed below. Verbal consent was given by the participants before participating. Each participant was issued an iPad to take the survey within the area designated for the study and was offered a University backpack or phone wallet after completing the survey.

The study was approved for waiver of the written consent process by the Institutional Review Board (IRB) of the academic University. An IRB-approved consent script was presented to the participants to obtain verbal consent. All questionnaire responses were anonymous.

Participants were of consenting age (18 years of age or older) and either parents or caregivers of children or individuals who were expecting or planning to be a parent/caregiver in the next few years. We included participants with the second criterion, because our lab studies effects of NIBS in infants and young children and understanding perceptions of the participants who are planning to be a parent in near future might be helpful to construct future NIBS studies.

Study variables

We collected demographic data, data regarding perception of safety related to NIBS, preferred terminologies and environmental and other factors to enroll children in research. Details of how the participants responded to related questions are discussed below.

Perception of non-invasive brain stimulation safety.

The participants were asked to respond to different encoded visual cues and statements. To assess the perception of risk level about specific NIBS techniques, photographs of two forms of NIBS – transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS), in different settings were shown to participants (See Supplemental Materials). There were two photographs of tDCS with an older child sitting at a table. In one, the child was performing an upper-limb activity, and in the other, the child was not performing an activity. There were two photographs of TMS as well: one showing a TMS assessment with an infant and the other with an older child. The participants were asked to indicate their perceived level of risk associated with each photograph using a Likert scale ranging from 1 to 5, where 1 and 5 were “very risky” and “not at all risky”, respectively. To understand the participants’ general idea about NIBS safety, different statements about NIBS were presented and participants were asked to state to what extent they agree (“Strongly disagree”, “Disagree”, “Neutral”, “Agree” and “Strongly agree”) with each statement. Likert scales can be used as both numerical and verbal response descriptors. A five-point Likert scale is a common scale format used in social and marketing studies, and having a neutral category in the middle is a good way to not force respondents to choose an answer (Dawes, 2008). Therefore, we chose to use the five-point Likert scales in our survey.

Factors influencing parental perceptions.

The participants were asked to score six different factors (“location of the study”, “monetary compensation”, “health benefit to the child”, “time of year”, “evidence of safety” and “time commitment”) on a scale of 1–5 to indicate how important that factor would be to enroll children in research, wherein 1 and 5 meant “not at all important” and “very important”, respectively.

Perception of riskiness of terminology.

The participants were asked to score six different terminologies related to brain stimulation techniques (“NIBS”, “non-surgical brain stimulation”, “non-invasive brain activation”, “non-invasive brain therapy”, “non-surgical brain therapy” and “focused brain activation”) on a scale of 1–5 to indicate perceived level of risk associated with each terminology, wherein 1 and 5 meant “very risky” and “not at all risky”, respectively.

Preferences of environment.

The participants were asked to choose a color from red, blue and yellow to indicate which one would make them feel “safest” during a medical procedure.

The participants were also shown two photographs of magnetic resonance imaging (MRI) suites to select which one they would trust most in the care of their child: a conventional MRI suite or a child-friendly decorated suite (See supplemental files, full survey and visuals).

Data analysis

We focused on presenting the data collected from current parents. Data were analyzed by measuring the frequency of responses using descriptive statistics. For Chi-square analysis (and Fisher’s exact test when the cell counts were <5), we collapsed the Likert scale responses into three categories. Depending on the question, the categories were:

1. “Risky”/“not important” (ratings “1” and “2” on the Likert scale) and “Disagree” (ratings “Strongly Disagree” and “Disagree”);

2. “Neutral” (rating “3” or “Neutral”); and

3. “Not risky”/“important” (ratings “4” and “5”) and “Agree” (ratings “Agree” and “Strongly Agree”).

Two categories for the parents’ highest educational level completed were established:

1. high school or equivalent; and

2. higher education (including associate, baccalaureate and graduate degrees).

We compared responses of parents with and without a CWD. Parents having multiple children with at least one CWD were considered under the CWD subgroup, as the majority of parents who had a CWD in our sample also had a TDC. Correction for multiple comparisons was not carried out due to the exploratory nature of the study. Responses from participants who did not answer all survey questions, or responses which lacked variability in response pattern (e.g. answered all questions “1”) were considered as incomplete and excluded from analysis. Data analysis was completed in Microsoft Excel and R, version 3.6.1. All p-values were two-sided and evaluated at the 0.05 level for statistical significance.

Results

Demographics

Initially, 650 people participated in the study, and subsequently 28 participant responses were excluded for incomplete surveys, with a final 622 responding participants. Demographics for the final sample (622) are shown in Table 1. In the subsequent tables, data from 416 parents were presented, as a means to evaluate only the perceptions of current parents.

Table 1:

Participant demographics. Numbers presented are frequency (%).

	All Participants	Type of Parent, n=416
	n=622	CWD	TDC
		n=54	n=362
Age Group (years)
18–24	71 (11.41)	0 (0)	2 (0.55)
25–34	61 (9.81)	1 (1.85)	23 (6.35)
35–44	78 (12.54)	5 (9.26)	54 (14.92)
45–54	115 (18.49)	17 (31.48)	80 (22.1)
55–64	158 (25.40)	21 (38.89)	112 (30.94)
65+	139 (22.35)	10 (18.52)	91 (25.14)
Education
High school or equivalent	133 (21.38)	7 (12.96)	54 (14.92)
Associate degree	121 (19.45)	11 (20.37)	74 (20.44)
Baccalaureate	166 (26.69)	13 (24.07)	99 (27.35)
Graduate	202 (32.48)	23 (42.6)	135 (37.29)
Region
In state (Minnesota)	569 (91.48)	49 (90.74)	332 (91.71)
Out of state	48 (7.72)	5 (9.26)	30 (8.29)
Missing	5 (0.80)	0 (0)	0 (0)

TDC: Typically developing child

CWD: Child with a disability

The number of non-parents is excluded in the “Type of Parent” columns.

Perception of non-invasive brain stimulation safety

Real-life photographs.

Less than 30% of all parents perceived all real-life photographs of NIBS techniques as risky (Table 2). Perception of risk was significantly associated with presence or absence of a concurrent activity in the photographs of tDCS. A total of 262 (62.98%) parents perceived the photograph of tDCS without an activity as not risky compared to 311 (74.76%) parents perceiving the photograph of tDCS with an activity as not risky (p < 0.001). In addition, there was a significant association between perception of risk and age of the child in the photographs involving TMS, with 209 (50.24%) parents perceiving the TMS assessment with an infant as not risky compared to 173 (41.58%) parents perceiving the TMS assessment with an older child as not risky (p = 0.043). There were no statistically significant associations of perception of risk level with NIBS photographs when compared among parents with or without a CWD (Table 2) or across educational levels (Table 3).

Table 2:

Respontses regarding picture and statements. Numbers presented are frequency (%).

		Type of Parent
	All Parents n = 416	CWD n = 54	TDC n = 362	p-value+ comparing responses between parent type
Picture Questions
tDCS without an activity				0.297
Risky	49 (11.78)	4 (7.41)	45 (12.43)
Neutral	105 (25.24)	11 (20.37)	94 (25.97)
Not Risky	262 (62.98)	39 (72.22)	223 (61.60)
tDCS with an activity				0.291
Risky	26 (6.25)	1 (1.85)	25 (6.90)
Neutral	79 (18.99)	9 (16.67)	70 (19.34)
Not Risky	311 (74.76)	44 (81.48)	267 (73.76)
P-value comparing pictures of tDCS with and without activity	< 0.001*
TMS assessment with an infant				0.860
Risky	84 (20.19)	10 (18.52)	74 (20.44)
Neutral	123 (29.57)	15 (27.78)	108 (29.83)
Not Risky	209 (50.24)	29 (53.70)	180 (49.73)
TMS assessment with an older child				0.369
Risky	98 (23.56)	12 (22.22)	86 (23.76)
Neutral	145 (34.86)	15 (27.78)	130 (35.91)
Not Risky	173 (41.58)	27 (50)	146 (40.33)
P-value comparing pictures of TMS with an infant and older child	0.043*
Statement Questions
NIBS is safe to use in adults				0.192
Disagree	15 (3.61)	0 (0)	15 (4.14)
Neutral	127 (30.53)	14 (25.93)	113 (31.22)
Agree	274 (65.86)	40 (74.07)	234 (64.64)
NIBS is safe to use in children				0.452
Disagree	42 (10.1)	5 (9.26)	37 (10.22)
Neutral	168 (40.38)	18 (33.33)	150 (41.44)
Agree	206 (49.52)	31 (57.41)	175 (48.34)
NIBS Hurts				0.113
Disagree	243 (58.41)	33 (61.11)	210 (58.01)
Neutral	138 (33.17)	15 (27.78)	123 (33.98)
Agree	35 (8.42)	6 (11.11)	29 (8.01)

NIBS: Non-invasive brain stimulation; tDCS: Transcranial direct current stimulation; TMS: Transcranial magnetic stimulation; CWD: Child with a disability; TDC: Typically developing child

P-values under row headings denote comparison of response from two corresponding pictures

P-value⁺s under column headings denote comparison of each picture between parents of CWD and TDC

Table 3:

Parental perception of safety according to level of education. Numbers presented are frequency (%).

	Level of education
	HS or equivalent n = 61	Higher education n = 355	p-value
Picture Questions
tDCS without an activity
Risky	8 (13.11)	41 (11.54)	0.429
Neutral	19 (31.15)	86 (24.23)
Not risky	34 (24.23)	228 (64.23)
tDCS with an activity
Risky	5 (8.2)	21 (5.92)	0.667
Neutral	13 (21.31)	66 (18.59)
Not risky	43 (70.49)	268 (75.49)
TMS assessment with an infant
Risky	15 (24.59)	69 (19.43)	0.534
Neutral	19 (31.15)	104 (29.3)
Not risky	27 (44.26)	182 (51.27)
TMS assessment with an older child
Risky	14 (22.96)	84 (23.66)	0.711
Neutral	24 (39.34)	121 (34.09)
Not risky	23 (37.7)	150 (42.25)
Statement Questions
NIBS is safe to use in adults
Disagree	3 (4.91)	12 (3.38)	0.457
Neutral	22 (36.07)	105 (29.58)
Agree	36 (59.02)	238 (67.04)
NIBS is safe to use in children
Disagree	5 (8.2)	37 (10.42)	0.612
Neutral	28 (45.9)	140 (39.44)
Agree	28 (45.9)	178 (50.14)
NIBS hurts
Disagree	26 (42.62)	217 (61.13)	0.025*
Neutral	28 (45.90)	110 (30.99)
Agree	7 (11.48)	28 (7.88)

CWD: Child with a disability, TDC: Typically developing child, HS: High School

tDCS: Transcranial direct current stimulation, TMS: Transcranial magnetic stimulation

P-value denotes comparison of each picture between parents with different educational level

Statements.

A majority (274, 65.86%) of parents agreed that “NIBS is safe to use in adults” and disagreed (243, 58.41%) that “NIBS hurts” (Table 2). When compared among parents with or without a CWD, the responses did not achieve statistical significance (Table 2). However, for the statement “NIBS hurts”, there was a statistically significant association with parental educational level (p = 0.025) such that 217 (61.13%) parents with higher education and 26 (42.62%) parents with high school or equivalent degree disagreed with this statement (Table 3). The results for parental perception of safety based on having a TDC or CWD are summarized in Table 2. The results according to parental educational levels are summarized in Table 3.

Factors influencing parental perceptions

Perception of importance regarding any of the factors did not achieve statistical significance when compared among parents with or without a CWD (Figure 1). There was a statistically significant association of the factors “monetary compensation”, “time of year” and “evidence of safety” with parental educational levels (p = 0.001, p < 0.001 and p = 0.003, respectively); more parents with a high school degree or equivalent education identified “monetary compensation” as important and “time of year” and “evidence of safety” as not important (Table 4). A majority of parents identified “potential health benefit to the child” (353, 84.85%) and “evidence of safety” (359, 86.3%) as important factors to enroll children in research. Table 4 summarizes the responses according to parental educational levels.

Figure 1:

Responses of all participants and parents of CWD and TDC regarding factors influencing parental perceptions to enroll children in NIBS Research.

Table 4:

Factors influencing parental perceptions according to level of education Numbers presented are frequency (%).

		Level of education
	All Parents n = 416	HS or equivalent n = 61	Higher education n = 355	p-value
Factors
Location of the study
Not important	95 (22.84)	14 (22.95)	81 (22.82)	0.952
Neutral	88 (21.15)	12 (19.67)	76 (21.41)
Important	233 (56.01)	35 (57.38)	198 (55.77)
Monetary compensation
Not important	220 (52.88)	28 (45.9)	192 (54.08)	0.001*
Neutral	105 (25.24)	9 (14.75)	96 (27.04)
Important	91 (21.88)	24 (39.35)	67 (18.88)
Potential health benefit to the child
Not important	18 (4.33)	3 (4.92)	15 (4.23)	0.952
Neutral	45 (10.82)	7 (11.48)	38 (10.7)
Important	353 (84.85)	51 (83.6)	302 (85.07)
Time of year
Not important	183 (43.99)	40 (65.57)	143 (40.28)	<0.001*
Neutral	105 (25.24)	7 (11.48)	98 (27.61)
Important	128 (30.77)	14 (22.95)	114 (32.11)
Evidence of safety
Not important	20 (4.81)	8 (13.11)	12 (3.38)	0.003*
Neutral	37 (8.89)	3 (4.92)	34 (9.58)
Important	359 (86.3)	50 (81.97)	309 (87.04)
Time Commitment
Not important	80 (19.23)	15 (24.59)	65 (18.31)	0.499
Neutral	111 (26.68)	16 (26.23)	95 (26.76)
Important	225 (54.09)	30 (49.18)	195 (54.93)

HS: High school

P-value denotes comparison of each factor between parents with different educational level

Perception of risk of terminology

Perception of risk level regarding any of the terms did not achieve statistical significance when compared among parents with or without a CWD (Figure 2). Responses for the terms “NIBS”, “Non-invasive brain activation” and “Non-invasive brain therapy” had a significant association with parental educational levels (p = 0.049, 0.017 and 0.03, respectively) wherein more parents with a higher educational level perceived these terms as not risky (Table 5). Above all other statements, a higher proportion (276, 66.34%) of parents perceived the terminology “Non-invasive brain therapy” as not risky. Table 5 summarizes the results based on parental educational levels.

Figure 2:

Responses of all participants and parents of CWD and TDC regarding perception of riskiness of study terminology.

Table 5:

Parental perception of riskiness of terminologies according to level of education. Numbers presented are frequency (%).

		Level of education
	All Parents n = 416	HS or equivalent n = 61	Higher education n = 355	p-value+
Terms
Non-invasive brain stimulation
Risky	58 (13.94)	14 (22.95)	44 (12.39)	0.049*
Neutral	90 (21.63)	15 (24.59)	75 (21.13)
Not risky	268 (64.43)	32 (52.46)	236 (66.48)
Non-surgical brain stimulation
Risky	61 (14.67)	15 (24.59)	46 (12.96)	0.052
Neutral	111 (26.68)	16 (26.23)	95 (26.76)
Not risky	244 (58.65)	30 (49.18)	214 (60.28)
Non-invasive brain activation
Risky	66 (15.87)	17 (27.87)	49 (13.8)	0.017*
Neutral	119 (28.61)	13 (21.31)	106 (29.86)
Not risky	231 (55.52)	31 (50.82)	200 (56.34)
Non-invasive brain therapy
Risky	49 (11.78)	12 (19.67)	37 (10.42)	0.030*
Neutral	91 (21.88)	17 (27.87)	74 (20.85)
Not risky	276 (66.34)	32 (52.46)	244 (68.73)
Non-surgical brain therapy
Risky	56 (13.46)	13 (21.31)	43 (12.11)	0.093
Neutral	98 (23.56)	16 (26.23)	82 (23.1)
Not risky	262 (62.98)	32 (52.46)	230 (64.79)
Focused brain activation
Risky	85 (20.43)	16 (26.23)	69 (19.44)	0.329
Neutral	106 (25.48)	17 (27.87)	89 (25.07)
Not risky	225 (54.09)	28 (45.9)	197 (55.49)

HS: High school

P-value denotes comparison of each factor between parents with different educational level

Preferences of environment

Color choice.

A majority (326, 78.37%) of parents chose blue as the color that would make them feel “safest” during a medical procedure. Choice of color did not have a statistically significant association with the groups of parents with or without a CWD or parental educational levels (results not shown).

Magnetic resonance imaging settings.

Over 90% (389/416) of parents chose the photograph of the child friendly MRI suite. Choice of MRI setting did not have a statistically significant association with the groups of parents with or without a CWD or parental educational levels (results not shown).

Discussion

Development of a perception involves complex neurological processing (Copenhaver, 2010). Pre-existing knowledge and sensory cues play important roles in perception development and memory encoding (Zacks et al., 2007). Perceived level of risk about a procedure has significant impact on decision-making; therefore, understanding about perception is integral to understand the decision-making pattern (Williams and Noyes, 2007). Inputs in terms of colors, words and surroundings are proved to be associated with perceptions of risk (Williams and Noyes, 2007), and in our survey at the 2018 Minnesota State Fair, we used these basics to understand parental perceptions of risk level regarding pediatric NIBS research. From this study, three generalizations about terminology, photographs/colors and safety information can be made specific to marketing communication/recruitment materials that could enhance outcomes as the potential consumers (parents/caregivers) work their way through the decision-making process. Results suggest that to have the greatest active effect on improving RER in pediatric NIBS studies, thorough understanding of parental perception is required. For satisfactory RER, recruitment materials and messages (mailings, website, newsletters, social media, etc.) should focus on specific terminology, colors and photographs and promote the safe application of the techniques. Each point of interest is discussed in the following sections.

Terminology

A previous survey suggested that parents were willing to incorporate brain stimulation as a treatment if the technique improved children’s well-being (Wagner et al., 2018). Our survey results had similar findings in regard to considering NIBS as treatment. All of the terminology for the naming of NIBS techniques were deemed by the study participants to be generally safe, and a majority of participants perceived “Non-invasive brain therapy” as the less risky option of word associations, although it did not reach the level of statistical significance. NIBS in pediatric populations has not yet been established as a clinical therapeutic option. However, with continued scientific exploration, there is potential that NIBS might be approved as a therapy for children with disabilities. What is known generally is that when consumers learn of new products or services, they use cues (marketing collateral) to help make decisions efficiently (Meyers-Levy and Tybout, 1997). More importantly, the perception of adopting the new products or services often are biased based on the cues, especially in the context of parents agreeing to clinical trials involving their children (Tait et al., 2003). Using the right words in the proper context with respect to any marketing communication has shown to influence the general consumer’s decision-making towards purchase (Hansen, 2005). Our results suggest that further exploration in a larger sample size regarding the use of the term “Therapy” rather than “Stimulation” may improve recruitment in future neuromodulation studies.

Photographs/colors

We anticipated that being unfamiliar with NIBS techniques, the majority of parents questioned in our study would perceive some of the photographs regarding pediatric NIBS as risky. In considering this, the study design was built based on the semiotic approach used in marketing communication. Semiotics is the study of how participants interpret signs (Zakia and Nadin, 1987), in this case pictures of NIBS, that influences decision-making. Typically, marketers think of the semiotic approach as a three-legged stool where there is the brand, the symbol and the “interpretant” (consumer) (Lawes, 2018). Consumers are influenced or at least their decision-making and perception of risk vs. reward when the semiotic approached is used in communicating to the market. Understanding these phenomena, different pictures were used in the study to determine if there was an effect of level of riskiness and therefore perception of the risk/reward payoff. Using the semiotic model, we tested the brand (NIBS), varying symbols (pictures and colors), to see the interpretation (effect) by the study participants.

We observed that more participants responded that the photograph of NIBS with a concurrent activity was not risky when compared to responses of the photograph of NIBS without an activity. Therefore, if applicable, real-life photographs showing participants receiving NIBS while performing an activity may improve the perception of safety. Additionally, we found that pictures having less “medical” equipment/wires were found to be less risky.

Parents expect easy accessibility, good care coordination and referral follow-up facilities while seeking service in primary and specialty care settings for children (Vander Schaaf et al., 2017). However, there is little data regarding parental preferences of appearance of environment and colors associated with pediatric medical procedures. Patients’ satisfaction or dissatisfaction regarding a procedure may impact their psychology and perception of health-care status (Fitzpatrick, 1991). There are studies that have shown association of patients’ high level anxiety with MRI examination particularly if there was a prior undesirable imaging experience (Mackenzie et al., 1995). In contrast, another study has shown that those perceiving MRI as a treatment tool reported a reduced degree of pain after MRI completion (Duymuş et al., 2016). The earlier studies performed to understand MRI perceptions focused on adults who themselves were patients, but ours is the first that focused to understand parental preferences of MRI for their children. We particularly chose photographs of MRI technique because it is one of the core diagnostic tool in the field of neurology for both treatment and research purpose. The majority of survey respondents choosing a child-friendly MRI suit suggests that portraying study environment in a child-friendly manner may influence parental perception and thus RER. Regarding colors, when tested we found that the color blue was preferred by participants as one representing comfort and safety. The significance of the impact of color in marketing communications and semiotics is well established in the field (Kauppinen-Räisänen and Jauffret, 2017). In fact, the meaning of a specific color to the interpretant can have different meanings based on the context with the object (Bottomley and Doyle, 2006). As blue tested as less risky and more comforting, any newly developed marketing material should consider a blue pantone range if possible, within the style guidelines of the lab.

Efficacy and safety

The baseline level of parental knowledge regarding a health-related intervention for children and corresponding health professionals’ behaviour plays an important role to maintain parental adherence to the intervention (Lillo-Navarro et al., 2019). In addition, finding something positive from adverse life situations is a common psychological coping mechanism for parents of children with a chronic illness (Pierce et al., 2019). Supporting these ideas, we found that most participants thought knowledge regarding safety and potential health benefit related to a technique are important factors to involve children in research. However, in contrast with prior study findings that showed monetary incentives can significantly increase research participation (Yu et al., 2017; Gardiner and Bryan, 2017), our survey results suggested that less than 50% of participants perceived monetary compensation as important to involve children in research. A majority of parents with higher education perceived “Monetary compensation” as not important. This might be due to the fact that our survey involved concerns of health and safety of children which is naturally more important to a parent than any financial benefit.

Although “time of year” was perceived to be “not important” by a majority of parents (both high school graduate and beyond) in our survey, feedback from families participating in previous pediatric NIBS studies suggested that participation during the summer months was preferred by many parents, as school-age children are more available during this time (Gillick et al., 2014; Rich et al., 2018; Gillick et al., 2018). However, study duration, length of stay in the research facility, age of the children participating and weather of the region where the research facility is located are also important aspects to consider when discussing research participation during a specific time of year. As NIBS has been found to be safe in small-scale pediatric studies, recruitment material should promote the evidence of NIBS safety over other variables.

Training in education and neuroscience is important for the general public as well as educators for perceptions regarding brain research (Macdonald et al., 2017). Our survey results suggest that perceptions of safety and enrollment factors had significant associations with the level of education of parents. Therefore, while trying to establish good communication with parents, parental educational background should be taken into account when determining the vocabulary to introduce studies in recruitment materials.

Implementation of marketing theory to recruitment, enrollment and retention

With over a decade of pediatric neuromodulation research, our lab has found challenges in RER for children in NIBS studies. The most common reasons for exclusion of participants are incompatible diagnosis and no follow-up response from initial consultation with families, with fewer than 50% of eligible parents/families choose to enroll in studies (Kowalski et al., 2019). The lack of response is of particular interest as eligible candidates might provide important data towards the scientific justification regarding pediatric NIBS. One potential reason for this lack of response might be an incomplete or false perception of NIBS regarding its nature of application and/or safety based on how the recruitment material is encoded. As NIBS holds promise to benefit pediatric populations, the inability to enroll the majority of participants who meet the inclusion criteria may delay further research and improved outcomes. One possible reason for the low participation rate is that parents are opting out of studies as a result of falsely perceiving NIBS as very risky and/or not as effective as other treatment options. There is potential that recruitment messages that use current marketing tactics (email, website, mailings, posters, etc.) are poorly decoded by the parents, likely due to unfamiliarity of complex medical terminology and practices used in the communication as well as perceptual bias (Kemp et al., 2015). Also, for years, the media through movies and television have presented treatment modalities involving other forms of brain stimulation as a treatment of seizure (i.e. not NIBS) as an unpleasant experience for patients, with a majority of the results of these treatments shown to be damaging rather than beneficial (Sienaert, 2016). As a result, marketing theory, strategy and tactics posit that creating an encoded message with the semiotic model and the specific target population in mind is critical to eliciting desired behaviour. In the case of health care and clinical trials, the product purchased may be considered enrolment and agreement in participation in a clinical trial.

The five step decision-making process of recognizing needs, searching for alternative solutions, evaluating alternative solutions, purchasing (deciding) and evaluating behaviour is important to understand as each step offers an opportunity for a stimulus (encoded message) to influence the consumer (potential participants) (Edwards, 1954; O’Brien, 1971; Schuster, 2015). One strategy to examine this decision-making process is to test varying encoded messages with the intended market. In this study, we integrated marketing theory with our study design strategy in translational neuroscientific applications of NIBS in a specific population. We were able to determine certain factors in a broad domain that are important for parents to involve children in research. How the parents perceive the potential clinical trial comes from many input sources, some of which do not reflect accurately the risk and rewards associated with the trial. To help mitigate the negative or neutral associations, sound marketing strategy and tactics can be used to more effectively match encoded recruitment stimuli to decoded understanding. Having a positive match and therefore association has the potential to influence the perception positively, therefore affecting attitude and ultimately behaviour.

Limitations and further research

Although this survey identified aspects crucial in recruitment for pediatric NIBS research, there were limitations. For example, the readability assessment of our survey performed afterwards showed that the language was of tenth grade level, and therefore it might have been difficult for average respondents to interpret (Calderón et al., 2006). Our study was limited by the arrangement of survey pictures and questions being presented in a consistent, non-randomized order. We did not record the sex, or demographic distribution (e.g. rural versus urban setting) of the participants. These factors may also influence recruitment messaging. Dividing the responses according to the sex of the participants would have been beneficial to establish communication with parents of future child participants in research. Both parents of a child might have taken the survey and given similar responses, as we did not have restrictions over the number of participants from the same household. We did not take into account exposure of the participants to the biomedical field, either professionally or as a consumer which may have added bias to the perceptions. There may have also been bias while responding to the pictures of TMS, as the setting in the two pictures was different. As the survey was delivered on an iPad, a few individuals experienced technical difficulties. We also did not analyse the data according to age group. We collapsed the five-point Likert scale into a three-point Likert scale to have enough frequencies in each scale to perform Chi-square analysis. Furthermore, the data might not be generalizable to the general population within and outside of Minnesota. A large percentage (78.62%) of self-selecting survey respondents had higher levels of education whereas in practicality less than 50%of Minnesota population may have attained this education level (www.ohe.state.mn.us/fc/2108/pg.cfm). This higher education level may indicate toward respondents’ preformed understanding of university conducted research; thus, a majority perceiving NIBS as safe which may not be the perception of general population of the USA. The other reason of having our sample different demography from general population may be that, the percentage of minority population of Minnesota is not comparable with that of the other states (www.governing.com/gov-data/census/state-minority-population-data-estimates.html) and the entry fee for entrance into the fair may not be affordable to all families.

To further understand parental preferences regarding participation in pediatric NIBS research, a follow-up study integrating the messages informed by this survey could be conducted to test whether changes made in marketing communication material had any effect on RER. Additionally, a qualitative approach such as focus group or individual interview data might provide insights not measured in our quantitative questionnaire that could be meaningful in future development of marketing communication materials.

Conclusions

We investigated and identified variables preferred by parents when considering NIBS and enrolling children in research. The obtained information from this survey may also be used in other pediatric research realms to test influence on recruitment, and if found effective, can contribute to produce meaningful results for the studies so far limited with low pediatric participation.

About the authors

Dr Michael Behan completed his PhD in Marketing from the Capella University in 2013, with a master’s degree from the University of Minnesota in Business Education, and an undergraduate degree in Marketing from the University of Wisconsin-Eau Claire. Prior to joining Winona State University as an Assistant Professor Marking, Dr Behan was an Assistant Professor of Marketing, Department Chair and Teacher of the Year at Viterbo University. His teaching and research focus is on how experience impacts the value proposition.

Tanjila Nawshin has recently completed her MS in Rehabilitation Science from the University of Minnesota. She is a Physician from Bangladesh and has six years of clinical experience in internal medicine including critical care areas. She aspires to pursue her career as a researcher, and her areas of research interests include neurologic diagnoses such as stroke, cerebral palsy, phantom limb pain and use of novel techniques to rehabilitate the individuals with disabilities resulting from neurologic injury.

Dr Samuel Nemanich completed his PhD in Movement Science from Washington University in St. Louis. After completing a post-doctoral research position in the Department of Rehabilitation Medicine at the University of Minnesota, he recently joined the Department of Occupational Therapy at Marquette University as an Assistant Professor. He is an expert in Matlab programming, scientific writing and designing clinical research. His research interests include motor control and learning in children, neurophysiology and neuroimaging.

Jesse Kowalski attained her Doctor of Physical Therapy degree from the University of North Carolina at Chapel Hill and is currently pursuing her PhD in Rehabilitation Science at the University of Minnesota. She holds expertise in pediatric physical therapy and has contributed to research in the field of pediatric neurorehabilitation and neuromodulation. She is currently an NIH TL1 Translational Research and Career Training Program Predoctoral Scholar at the University of Minnesota and is investigating epigenetic and neuroimaging biomarkers of pathology and recovery after spinal cord injury.

Ellen Sutter recently graduated with her Doctorate of Physical Therapy and is continuing to pursue her PhD in Rehabilitation Science at the University of Minnesota. She is fascinated by clinical research involving neuroscience and rehabilitation, and her major areas of research interest include neurorehabilitation for pediatric and adult populations; including non-invasive brain stimulation in infants and children with cerebral palsy. She has published multiple papers in her areas of interest and presented her work in a number of local and national conferences.

Dr Sunday Francis completed her PhD in Computational Neuroscience from the University of Chicago exploring neuroplasticity, specifically the effects of motor learning on motor cortex. Currently, she is a post-doctoral associate in the Department of Psychiatry and Behavioral Sciences at the University of Minnesota. She researches different aspects of autism spectrum disorder (ASD) that include understanding brain connectivity and the underlying neural mechanisms of this disorder. She is also affiliated with the Gillick Pediatric Neuromodulation Laboratory in the Department of Rehabilitation Medicine at the University of Minnesota to develop deeper understanding on the potentials of non-invasive brain stimulation techniques in individuals with ASD and other neurodevelopmental disorders.

Dr Janet Dubinsky is a Professor in the Department of Neuroscience at the University of Minnesota. Her primary research involves investigating alteration of metabolites in brains of model mice with Huntington’s Disease, and potential of these alteration to be used as biomarkers and means of understanding the mechanism of disease progression. In addition, she investigates the impact that neuroscience knowledge has upon K-12 teachers’ beliefs, pedagogy and students through the BrainU professional development program (BrainU.org). The BrainU program provides K-12 teachers with an understanding of brain plasticity and development that supports the ongoing growth associated with education and the best classroom practices to achieve student success.

Rebecca Freese completed her MS in Biostatistics from the University of Minnesota and is currently working as a biostatistician at the University of Minnesota Biostatistical Design and Analysis Center of the Clinical and Translation Science Institute. Previously, she worked as a data science intern at Metro Transit where she developed expertise in analyzing large data sets and building R Shiny applications to support data-driven decisions. She continues to contribute to research as a biostatistician, using her wide range of expertise in the field.

Dr Kyle Rudser is an Associate Professor of Biostatistics in the Division of Biostatistics at the University of Minnesota. He completed his MS and PhD in Biostatistics from the University of Washington. His statistical methods work is in the areas of survival analysis and the design, monitoring and analysis of clinical trials. He collaborates with investigators across the Academic Health Center on clinical and translational research.

Dr Bernadette Gillick, PhD, MSPT, PT is an Associate Professor and McKnight Land Grant Professor in the Divisions of Physical Therapy and Rehabilitation Science, and faculty of graduate program in Neuroscience at the University of Minnesota. She earned her PhD from the Division of Rehabilitation Science with a minor in Neuroscience from the same university after completing her Advanced MS on Neurologic Physical Therapy from Chicago Medical School. Her research interest involves understanding the potentials of different forms of non-invasive brain stimulation in improving motor function after neurologic insult. One of her major current research supports includes an NIH R21 to investigate perinatal brain injury using multimodal assessment.