‘Would you take a drug for this?’: attitudes by individuals with traumatic brain injury towards medication to improve social functioning
Sandra Reeder
A * , Katherine Sewell A , Natasha A. Lannin A B , Madeleine J. Smith A and Bridgette D. Semple A B
A
B
Abstract
Many people with traumatic brain injury (TBI) report problems with social functioning that can have immediate and enduring impacts. We aimed to explore perceptions of social functioning after TBI and understand attitudes towards medication that could improve long-term social outcomes.
A qualitative descriptive approach using interview methods was conducted in Victoria, Australia. Using purposive sampling we conducted 15 semi-structured interviews with people with moderate to severe TBI between July and September 2021.
Using a framework approach, we thematically identified three themes: (1) impacts of TBI on social roles and activities, including changes in recreational activities and role changes in family units; (2) change in social networks, resulting from shifts in attitudes to social activities and mental health issues; and (3) openness to novel treatments to improve social functioning – willingness to take potential medication to improve social functioning and the factors that have an impact on decision making.
Our results highlight that people with TBI experience a range of changes in social participation post-TBI, and that they have a strong interest in improving their social functioning. Such insights provide opportunities to tailor patient-centric treatments and circumnavigate barriers in the early stages of medication development for successful translation into practice in this population.
Keywords: adjuvant drug therapy, interviews, medication, qualitative, rehabilitation, social functioning, social interaction, traumatic brain injury.
Introduction
Traumatic brain injury (TBI) is a complex injury that can impact all aspects of daily life. Many people with TBI, particularly after moderate or severe injury, report problems with social functioning. They experience cognitive and emotional problems (Sloan et al. 2009; Grauwmeijer et al. 2012; Sveen et al. 2013), challenging behaviours such as aggression, a lack of initiation or inappropriate sexual behaviours (Tam et al. 2015), and communication difficulties (Struchen et al. 2011), which affect their interpersonal interactions and relationships (Tomberg et al. 2007). The enduring impacts of social issues can include negative effects on a person’s work, employment, financial status, mental health, and independence (Johnstone et al. 2003). Despite these often devastating and wide-reaching impacts, no pharmacological treatments currently exist to specifically target social problems in this population. To enhance social function after TBI and reduce the impact on quality of life, it is possible that novel pharmacotherapeutics could be an effective strategy for improving social outcomes (Semple and Raghupathi 2021).
To date, research into social issues after TBI has largely focused on characterising social problems and identifying risk factors that contribute to poor social functioning after TBI. Social impairments are often closely aligned with cognitive, behavioural, and emotional deficits following TBI, particularly when injury is moderate or severe in nature (Torregrossa et al. 2023). Multifaceted individual, injury-related, and environmental factors are understood to shape social functioning after such injuries (Zamani et al. 2019). Insights into pathways for social recovery after TBI have emerged from Anderson et al. (2023), who identified five trajectories characterised by distinct biopsychosocial features. The authors explored the interplay of biopsychosocial factors as well as modifiable protective factors that underlie the development of post-TBI social impairment. While these insights increase our understanding of the factors that impact social recovery, they also underscore the complexity, diversity, and importance of future interventions needed to improve social functioning.
Research into interventions to improve social functioning after TBI is limited. In a systematic review examining the effect of different rehabilitation interventions for impairments in social cognition, the authors noted the limited studies targeting rehabilitation strategies for social cognition and function (Rodríguez-Rajo et al. 2022). Many existing rehabilitation strategies for TBI patients focus on social communication (Togher et al. 2013; Finch et al. 2016; Meulenbroek et al. 2019). Other behavioural interventions include the use of group- or project-based intervention approaches for cognitive-communication impairments after TBI (Behn et al. 2020, 2024; Keegan et al. 2020, 2024). However, no pharmacological treatments currently exist to specifically target social functioning in this population (Bozkurt et al. 2023).
Preclinical models of TBI have shown to recapitulate some of the social behaviour problems that present in individuals after a TBI (Ryan et al. 2016). These models are now being used to develop new therapies aimed at reducing the impact of social behaviour problems after a TBI. For example, research is underway into new pharmacological neuroprotective treatments to reduce the extent of brain damage in regions involved in social cognition, and therapies to promote social affiliation/interest and reduce social anxiety (Semple and Raghupathi 2021). One proposed novel approach for preventing or improving social behaviour issues is a medication that could be used as part of a multimodal approach (Semple and Raghupathi 2021). However, the future translation of this approach must be considered, particularly given adherence to taking prescribed medication in other chronic conditions such as epilepsy and attention deficit hyperactivity disorder can be low (Schoenfelder and Sasser 2016; Zafar et al. 2019). Reasons for discontinuing prescribed medication are multifactorial, but may include concerns about medication effects on temperament and personality (Charach and Fernandez 2013). Given these concerns, it is important to understand in detail what people think about taking a potential medication for improved social functioning. However, qualitative research exploring such perceptions is absent from the literature. Therefore, this study explored the perspectives of people with TBI with regard to taking new medication for improved social function after TBI to inform future translation of this work. In this study we aimed to examine how people with TBI perceived their social functioning, and their attitudes towards a hypothetical new medication that may improve social functioning.
Methods
Study design
We used a qualitative descriptive approach (Kim et al. 2017; Doyle et al. 2020) and semi-structured interviews to explore perceptions of social functioning after TBI and to understand attitudes towards medication as a treatment that could improve long-term social outcomes. Ethics approval for the study was provided by (anonymised) Human Ethics Committee (26 June 2021; project ID (anonymised)). This study was reported according to the recommendations of the Consolidated Criteria for Reporting Qualitative Studies (COREQ) (Tong et al. 2007), and the checklist is provided in the supplementary online material.
Participants and recruitment
Potential participants were initially recruited through consumer organisations in Australia that represented the interests of people with TBI. People were invited to participate via media advertisement broadcast by one national and one state-based community organisation. The advertisement linked to a secure online form where people could provide their name and contact details. As this process resulted in only one participant after 3 weeks, we then focused our recruitment efforts to the Victorian State Trauma Registry (VSTR). The VSTR is a population-based registry that captures data about all major trauma patients in the state (Cameron et al. 2005). Major trauma is defined as any of the following: death following injury, an Injury Severity Score >12, urgent surgery, or admission to intensive care for >24 h (Cameron et al. 2005). As part of the VSTR, patients who survive to hospital discharge are followed up by trained interviewers until 24 months post-injury.
The VSTR interviewers asked people with moderate and severe TBI who were 12 or 24 months post-injury if they were willing to participate in a semi-structured interview about their social functioning and a potential treatment for social dysfunction. Only participants, along with their basic demographic and contact details, who had been assessed by trained VSTR interviewers as competent to provide informed consent were passed onto the study research assistant (assessed through a brief discussion of the research/potential project to check understanding, comprehension, and retention of the information). When selecting potential participants to contact, we purposively sampled based on age (a range ≥18 years), gender (approximately 75% male, as males have a higher incidence of severe TBI than females), and employment status (employed/not employed). People who expressed an interest in the study were contacted by a research assistant and provided with details about the study, including an explanatory statement. The invitation to participate in a semi-structured telephone interview was also extended to include a relative or carer known to the person with TBI. All participants provided informed consent to participate in this study.
We estimated the size of our sample based on the ‘information power’ required (Malterud et al. 2016). Information power purports that the more relevant information a sample holds, the fewer participants required for the study. For our interview study, the estimated sample to address the research aims was 10–15 participants (Malterud et al. 2016). This estimate was based on the focused aims of the study, the use of purposive sampling, and the application of appropriate data collection techniques (interviews) and analysis method (framework analysis) (Malterud et al. 2016).
Data collection
We developed an interview guide based on the study objective – by drawing on other studies with similar aims – and our own experience with interviewing people with TBI (Table 1). Questions included participants’ self-perceptions of social functioning and their interest in, and thoughts and feelings about, a hypothetical medication that could improve social functioning. Other questions explored a range of factors that might make them more or less likely to take a hypothetical medication. A research assistant, trained and experienced in semi-structured interviewing, conducted and audio-recorded all interviews over the telephone between September and October 2022. The interviewer had a medical qualification and research experience, and had previously interviewed people with TBI in a clinical capacity. The interviewer had no clinical or prior relationship with the participants. The interviewer did not have a lived experienced of TBI. A description of the authors’ positionality is provided in the online supplementary material. As participants responded to the questions, the interviewer used probes to encourage explanation or expansion of their responses. Consent to participate was audio-recorded at the start of the interview, checked throughout the interview, and professionally transcribed with the rest of the recorded interview. Any identifying information was removed during the transcription process.
Data analysis
Data were thematically analysed using a framework approach (Ritchie and Spencer 1994). After loading the transcripts into NVivo version 20 (QSR International, Doncaster), three analysts read the transcripts (KS, SR, BDS). Two analysts (KS and SR) read them repeatedly before commencing data coding. Data were inductively coded based on the meaning, content, and relevance to the research question. KS coded all the transcripts and SR independently coded half of the dataset. To create a preliminary framework, the two coders worked iteratively to identify repetition and organise similar and related codes into categories and subcategories. The two analysts worked together to discuss the dataset and enhance conceptualisation of the analytical framework and create an initial analytical framework that responded to the aim of the study. The remaining transcripts were charted and indexed to this initial analytical framework, which was adjusted as new categories or sub-categories were identified. While examining the dataset, patterns were organised into final themes and subthemes with input from the wider project team.
Trustworthiness of the analysis
Multiple processes were used throughout the analysis to ensure trustworthiness of the results (Table 2).
| Trustworthiness process | How trustworthiness was achieved | |
|---|---|---|
| Data triangulation | Two researchers analysed the dataset (Morse 2015). | |
| Keeping an audit trail | Detailed records were kept to maintain an audit trail for the project duration. Key analytical and methodological decisions were recoded through memos in NVivo about coding and analytical decisions as well as written notes in a reflective journal (see below) (Lincoln 1995; Nowell et al. 2017; Braun and Clarke 2022). | |
| Peer discussion and debriefing | Peer reviews and debriefings were conducted to review and discuss the analysis, provide feedback on the analytical framework, and finalise the themes and subthemes (Morse 2015; Braun and Clarke 2022). | |
| Maintaining a reflexive journal | A reflexive journal documented the analysts’ thinking and decision making. Methodological and conceptual decision making, personal reflections, and insights were all documented to support transparent research processes (Nowell et al. 2017; Braun and Clarke 2022). | |
| Examining and monitoring for bias | The project group held regular meetings to discuss the developing analysis, and to examine and review potential bias. Varying interpretation and alternative explanations were discussed to enhance trustworthiness of the analysis (Morse 2015). | |
| Examination for disconfirming evidence | The dataset was examined for evidence of information that did not support the developing interpretation. We explored and discussed alternative interpretations and explanations before agreeing on the final analytical framework (Morse 2015). |
Results
A total of 15 participants (11 identified male gender) with moderate to severe TBI were interviewed. Most participants were greater than 1-year post-injury but less than 2 years, with one participant >20 years post-injury. The participants had a median age of 35 years (range 19–65) (Table 3). Four participants lived alone, five participants lived with their partners, and six lived with a relative or housemates. Similar proportions of people were employed (53%) as were unemployed (47%) at the time of the interview. The mean interview time was 27 min. Two participants had a significant other join their interview, but this second person provided minimal input during the participant’s interview.
| Descriptor (n = 15) | n | ||
|---|---|---|---|
| Gender | Male | 11 | |
| Female | 4 | ||
| Age | 19–39 years | 9 | |
| 40–65 years | 6 | ||
| Employed at time of interview | Yes | 8 | |
| No | 7 | ||
| Living arrangements | Alone | 4 | |
| With partner | 5 | ||
| With others (relative or housemates) | 6 | ||
| Residential location | Metro | 7 | |
| Inner regional | 3 | ||
| Outer regional | 5 |
Three main themes and multiple subthemes were identified. The first theme ‘Impacts of TBI impacts on social roles and activities’ explores the changes participants’ experienced in their recreational interests and activities, as well as the role changes they perceived to occur in their family unit post TBI. The second theme ‘Change in social networks’ reveals the limited social activity that participants described in their life and the psychological factors perceived to contribute to changes in social preferences. The third theme ‘Openness to novel treatments to improve social functioning’ shows participants’ interest in and receptive attitude towards taking medication to improve social functioning, and their thoughts about what factors would influence their decision making with respect to taking the potential medication. Exemplar quotes (in italics) are provided and additional quotes are available in the online supplementary material.
TBI impacts on social roles and activities
Many participants reported changes in their social activities after TBI. Altered physical, cognitive, and social functioning post-injury contributed to changes in activities and interests which subsequently had impacts on social participation. Most participants had discontinued playing sport and engaging in certain hobbies, and had stopped attending clubs, groups, and community gatherings. The reasons for these changes were multifactorial. Many participants cited changes in friendship groups post-TBI, noting ‘I’m no longer in the club, I’m out… I’m not living the same life now’ (Male_19–30 years_P7), while others were no longer driving or drinking alcohol, which caused a change in friendship groups. One participant reflected that, ‘A lot of socialising had to do with drinking… I came to realise they weren’t really friends; [they’re] drinking buddies’ (Female_50–60 years_P10).
Some participants stated motivational issues, fatigue, and sensitivity to environmental noise as reasons for changing hobbies, while others cited residual symptoms attributed to their TBI, such as hearing loss, dizziness, and poor balance, caused changes in their social activities. One participant described, ‘It [the TBI] had a big effect there [on activities and interests]. I was sporty, I played footy, and was pretty talented at that, and that’s never going to be the same’ (Male_19–30 years_P12). Further, physical constraints such as positioning and pain as described by the following participant, has impacts on social interest, ‘I can’t have my head down. My back just kills me – half an hour of bending my back just pains for the whole day… I’ll get the headaches… Now I don’t socialise like I used to’ (Female_50–60 years_P10).
Many participants reported that their role and responsibilities within their family had changed post-injury. Some experienced marriage breakdowns or a distancing of their relationship with their children or family. Role changes as a parent were noted by some participants. Participants with younger children stated that they were unable to undertake parenting activities like they used to, with a participant describing, ‘They [the children] don’t get the best of me like they used to. I don’t really feel like a father anymore. I feel like a third wheel in this household’ (Male 30–40 years_P5). Others stated that they needed to work with government organisations and systems to regain contact with their children. Parents of older children reported reduced contact and a change in their relationship with them. Some participants described mental health problems and a breakdown in their relationship with their partner, with one stating:
I’m still experiencing depression, which some days can be really not good. I can still work, but just anxiety. Obviously, my marriage has broken up. My self-confidence, my self-esteem is not great. I think more than physical, it’s been psychological. (Female 50–60yrs_P4)
Additionally, in some family units, changes in social roles occurred when the participant was working reduced hours or not at all, and therefore earning less money. A change in job role or employment status put extra ‘pressure’ on individuals and families, particularly when it caused other family members to also change their role in the family. For the following participant, their wife had to change her social role as an employed person to be the family’s ‘number one’ person. He stated:
My wife has had to give up her job to be the number one person in the household, where beforehand I used to work during the week […] And then all of a sudden, now it’s like she doesn’t work, and I’m not bringing in anywhere near the money I used to bring in. (Male_30–40yrs_P5)
Change in social networks
All participants described a change in their preferences for socialising post-TBI. Many reported wanting to withdraw from or limit their social activities, which was generally in contrast to their pre-TBI self. One participant described, ‘I actually prefer to not see people so much now’ (Female_50–60 years_P10). Others reported they narrowed their networks to selected family and/or friends noting, ‘I’ve got one [pre-injury friend]. Another friend I’ve got is a new one, and he’s like me, he’s got a TBI, so he knows what it’s like’ (Male_19–30 years_P7).
The reasons for reduced interest in socialising, and for some a preference to stay at home, were multifactorial. Participants reported that communicating, understanding, and interacting with others was a significant effort, particularly when they also felt highly sensitive to their surroundings (e.g. crowds and noise). Further, psychological barriers (described in subtheme 3.2.2 below), shifts in friendship groups, and a change in the perceived benefits from relationships, all altered participants’ attitudes towards social participation. Some participants described narrowed social networks with one participant noting ‘I guess I lost touch with all my friends… Not all, most’ (Male_19–30 years_P2) and some felt exploited as one participant described ‘… a lot of people [took] advantage of me’ (Male- 30–40 years_P3). Others stated ongoing fatigue with one participant noting, ‘I just feel like I’m too tired to do anything’ (Female_30–40 years_P13), while some felt discomfort from awkward interactions as stated by one participant, ‘It’s hard for me to think of the right things to say, think of the word’ (Male_40–50 years_P1). Some participants described attempts to adapt to outings, such as wearing headphones for dinner at a restaurant to reduce environmental stimulation, but the majority reported electing to limit or withdraw from social engagement, narrowing their social networks.
I watched the Grand Final by myself, whereas years ago I would have had a house full of people… everyone was eating and drinking, partying and having a good time. We’d all be spastic and laughing our heads off. Now, I could think of nothing worse. (Female_50–60yrs_P10)
The only thing that I do regularly is my son plays rugby… If I’m not working on a Saturday, I’ll go and support him and watch him play. Other than that… I go to work… I come back to my sister’s. I’ll help her with dinner or watch a bit of TV, and then I pretty much go to bed, and it all starts the next day again. I don’t really do anything. (Female_50–60yrs_P4)
Most participants described varying mental health conditions, symptoms, and feelings that resulted in reduced social participation and ultimately narrowing of their social network. While multiple factors as outlined in the previous subtheme were noted to contribute to reduced social participation, psychological factors were emphasised as having the greatest impact. For example, many reported feelings of anxiety, overwhelm, and vulnerability, while others stated that they had panic attacks in social situations. Some people described their anxiety as ‘irrational’ but felt unable to control it without withdrawing from social activities and returning home to a familiar environment. A distrust of others, loss of self-confidence, and fear of social participation developed, as it felt ‘…almost like it’s [in the] too hard basket’ (Female_50–60 years_P4). A few people reported that they had been diagnosed with depression and anxiety and linked their condition/s to a lack of interest and/or difficulty engaging in social relationships and activities. Many stated that they ‘felt better’ when on their own:
Because I’m in an anxious state, I’m irrational at the time, so I’m not thinking clearly, and I’m just thinking that something has gone wrong… I definitely isolate […] I don’t socialise. I don’t see my friends. I do tend to avoid answering the phone… I just feel better on my own and in my own space, and in my own comfort zone. (Female_30–40yrs_P14)
Openness to novel treatments to improve social functioning
All participants revealed open attitudes and an interest in taking a proposed medication that could improve their social functioning. The following participant’s statement captured a similar sentiment to others as they stated, ‘I’d take it – 100 per cent. The big thing in life is the social stuff and being able to have conversations… It would be really useful for people that have had my injury’ (Male_19–30 years_P12).
Participants reported that their motivation to try it related to wanting to improve their social functioning and because nothing had worked to date. Participants described their hopes for a medication to reduce their anxiety about social activities, to make socialising easier, and to ‘get back on track’ (Female_30–40 years_P14):
I’ve tried lots of different antidepressants and anti-anxieties and haven’t found any of them helpful. I even remember saying to my GP, I wish there was a magic pill out there… I’d hope that it would make me a lot better… socialize a lot better. (Female_30–40yrs_P14)
Some participants noted that the proposed medication may or may not work for them, but they were willing, nevertheless, to take the chance and see if they noticed any benefit:
I would happily take it. It’s the old suck and see, isn’t it? Yes, it worked. No, it didn’t. Otherwise no one finds out. Obviously, everyone is going to be different, but I would have no hesitation in taking it. (Male_60–70yrs_P15)
While participants were open to the idea of taking a proposed medication to improve their social functioning, they also reported several factors that would influence their final decision. Some participants expressed that they would like more information to help them decide, including how long they would need to take the medication for, how often, and what its properties would be. One participant noted, ‘If I had to have an injection every day, I really wouldn’t like that. But say, if it was once a month, I wouldn’t have an issue’ (Male_30–40 years_P5). Potential side effects (‘… as long as there are no side-effects it’s an easy decision’ (Male_40–50 years_P1)), drug interactions with other medications, and the cost of the medication (‘… if it costs a lot of money, that’s a different story’ (Male_50–60 years_P11)), were also raised as diverse reasons that could have an impact on their decision to take the hypothetical medication. Further, some weighed up the length of the medication course relative to the degree of impact it could have on improving social functioning, stating ‘I’d do it for lifelong, but if it’s a minor change, then it’s not worth me taking it for lifelong’ (Male_19–30 years_P2). Others reported that if they decided to take the proposed medication, the frequency at which they took it was unimportant, provided they felt it was making a difference. One participant explained, ‘I’d be prepared to do it whatever is effective. I’m happy to take it three times a day’ (Male_40–50 years_P1).
Participants also noted considerations related to their health professional that would support their decision to take the proposed medication. The value of trust was identified as central to decision making. Participants reported needing to feel that they could trust pharmaceutical companies to properly prepare the medication for market through research and testing, as well as trust a health professional to have researched the medication before prescribing or recommending it. For some participants, trust in the prescribing health professional was restricted to the type and length of existing relationship they had with them, or to the health professionals’ specialist knowledge. The ‘trust’ expressed by participants was connected to being prescribed a medication only if a health professional made a considered decision that it was in the participants’ best interest. One participant explained, ‘I would trust a specialist more so on a new drug over my GP because a GP hasn’t specialised in it’ (Female_30–40 years_P14), while another stated, ‘I’d have to trust my own GP at the end of the day. Not someone that I don’t deal with’ (Male_50–60 years_P11).
Discussion
Our results highlight that people with TBI experience a range of changes in social participation post-TBI, and that they have a strong interest in improving their social functioning. Changes in attitudes to social activities and preferences as well as social roles were reported, and for many, these changes were persistent and connected to further negative social consequences. All participants expressed their openness and willingness to taking medication that could improve their social functioning, with preferences for who prescribed the medication and how it would be administered. Understanding and incorporating stakeholder perspectives is vital for successful translation of interventions into practice (Gray-Burrows et al. 2018), and our results suggest that the development of a medication to treat social dysfunction after TBI is in line with the expectations, priorities, and hopes of people with TBI. Our findings also provide details about preferences for medication effectiveness (e.g. control of symptoms), properties (e.g. routes, frequency), and regime (e.g. how long the course is for), as well as considerations for side effects and drug interactions. Further, socioeconomic (e.g. cost) and health professionals (e.g. trust) factors were highlighted. Altogether, by better understanding the factors that could influence people with TBI to take a medication for improved social functioning, these findings can guide future preclinical and translational research towards drug preparations that would be considered acceptable to people with TBI.
The negative social impacts of TBI reported in our study reinforce results from previous work in this field (Tomberg et al. 2007; Sveen et al. 2013; Downing et al. 2021b; Mamman et al. 2022). Our findings build upon this work to show that people with TBI are interested in improving their social functioning. In further support of social improvement, social relationships and engaging in social networks are known facilitators for TBI recovery (Kersey et al. 2020; Downing et al. 2021a; Sveen et al. 2022), substantiating the need for investment in treatments. Laboratory research is currently underway to explore potential therapies for injury-induced changes in social functioning, including their relevance in brain injury specifically, as well as the biological mechanisms (Runyan et al. 2021; Semple and Raghupathi 2021; Dill et al. 2023). While minimally explored in the context of TBI to date, promising treatment exists for social functioning issues associated with other conditions such as autism spectrum disorder (Guastella et al. 2023). Potential treatments may include exogenous peptide therapeutics such as oxytocin, which is heavily implicated in social affiliation and appears to be well tolerated when administered non-invasively via the intranasal route (i.e. inhaled) (Semple and Raghupathi 2021). Additionally, there is potential to re-purpose existing drug treatments such as psychoactive drugs (e.g. amphetamines, 3,4-methylenedioxy-methamphetamine, some opioids, and cannabidiol) that can enhance social motivation (Bershad and De Wit 2023; Ferreira et al. 2023). Our findings here substantiate the need for improvement in social functioning in people with TBI, and indicate that people with TBI are supportive of continued research in this area.
Future exploration of these promising avenues should be considered in the context of our results, which show that – while people with TBI are interested in medication for the treatment of social functioning – there are several factors to consider. Overall, participants indicated that decision making was multifactorial, with medication effectiveness, the properties of the medication, its potential side effects, and the prescribed regime, all weighed up for consideration when deciding to take a medication for social functioning. Oral administration (e.g. a tablet) was noted to be more acceptable than injectables, and it was preferred that burden from frequency of medication taking be minimised for effective medication management. However, if the medication was effective, most noted that they would be less concerned with how often they needed to take it. As expected, undesirable side effects or interactions with other medications and cost were noted as important considerations in decision making. Altogether, these findings can inform the development of patient-centric medications for improved social functioning that could affect future medication acceptance and adherence for people with TBI. Further, while these medication factors provide important insights for future development, rich literature (Peh et al. 2021) forewarns of the diverse influences on medication adherence. While our study established a willingness and openness to taking medication for social functioning, future research in the context of the TBI population will need to explore adherence to prescribed medications for social purposes. The study also highlights the importance of including the experiences and perspectives of people affected by TBI when developing new medications and administration protocols.
Trust in the patient–provider relationship is an important aspect for promoting beneficial health behaviours, reducing symptoms, being satisfied with treatment, and reporting higher quality of life with improved health outcomes (Birkhäuer et al. 2017). Participants in our study emphasised the importance of trust not only in the health professional prescribing the medication, but also the pharmaceutical companies that manufactured the medication. The relationship with the medication prescriber was important to most participants as it was believed to signify a health provider’s intent to act in their patients’ best interests, a finding supported by others (Gabay 2015). For other participants, however, their health professional’s specialisation (e.g. general practitioner or neurologist) contributed to trust, with some stating they would not trust a general practitioner’s recommendation to take medication due to their lack of specialist TBI knowledge. For people with TBI, trust in health professionals can be eroded when they perceive that their health concerns are not being addressed, there is a perceived lack of empathy, or the effects of TBI are perceived to be downplayed or dismissed (Dams-O’connor et al. 2018; Hoepner et al. 2024). Trust can be strengthened in patient-provider relationships, resulting in improved patient outcomes, when patients perceive control over their health and they perceive communication with their health professional as participative (Gabay 2015). Future research in the context of TBI is needed to clearly understand trust in relationships between people with TBI and health professionals and the decision to take medication, to ensure people with TBI who seek improved social functioning have the opportunity to take up medication treatment options as they become available and receive the potential benefits.
Our study reveals that people with moderate to severe TBI are open and interested in medication treatments to improve their social functioning, and provides unique insights into factors that contribute to decision making about taking such a potential medication. In this study we underscore the importance of engaging early with consumers in the pre-clinical phase of developing novel treatments to understand perspectives, contextual factors, and decision making about potential medication to improve social functioning in people with TBI. Such insights provide opportunities to tailor patient-centric treatments and circumnavigate barriers in the early stages of development to support relevance and acceptability of future potential therapies in target populations (Jonker et al. 2023). Pre-clinical research in other fields has also reported benefits from early stakeholder consultation through surveys to understand in detail the acceptability of and consideration for novel and invasive treatments (Smith et al. 2023). Ultimately, stakeholder engagement in the design of healthcare interventions, treatments, and services supports ready adoption (Majid et al. 2018). While there are many steps before effective implementation of a medication for social functioning in people with TBI, researchers derive benefit from early understandings of their target population regarding the factors and influences that could impact acceptability and uptake. Such insights provide opportunities for researchers to address any issues, concerns, and/or hesitancy early in the development phase. While these findings help to direct preclinical research towards administration routes that would be acceptable to people with TBI, future research should also involve the parents of children with TBI to gain their perspectives of acceptability and considerations about medication route, frequency of administration, side effects, and costs.
Strengths and limitations
The findings from this study can be used to direct future preclinical and translational research in the field and to inform priority setting and decision making about clinical applications of new treatments. However, the study involved 15 people, and further work could build on these results in order to examine preferences and decision making about a medication for social functioning more broadly. Additionally, people with moderate to severe TBI may not have full insight into all of their social impairments, which could have resulted in underreporting. A further limitation is that only people with TBI who were fluent in English were included in the study.
Conclusion
After a moderate to severe TBI, diverse negative impacts on social functioning diffused through to other aspects of life including relationships, psychological health, and the ability to return to work. In this study, people with TBI wanted to improve their social functioning and medication was considered an acceptable treatment. Key considerations for a potential medication related to the route of administration, side effects, drug interactions, and trust in the health professionals prescribing or recommending the medication. Overall, early stakeholder engagement in the preclinical phase of research provided important insights for the future translation of this work, highlighting the importance of gaining patient perspectives early on during the drug development process.
Data availability
The data that support the findings of this study are available from the corresponding author, [SR], upon reasonable request and following local institutional ethics review.
Declaration of funding
No funding was provided for this project. Natasha A. Lannin is supported by a fellowship from the Heart Foundation of Australia (anonymised).
Acknowledgements
We would like to thank the people who participated in this research and Sandra Reeder for her assistance with the project. Nadia Moore was the leading author for this publication.
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