Drug-resistant epilepsy and ketogenic diet therapy – a qualitative study of families’ experiences.

Background: A diagnosis of drug-resistant epilepsy is life changing for a family. Ketogenic diet therapy (KDT) can offer hope when other treatments have failed. However, it often requires a significant change in daily routine and dietary habits. This qualitative descriptive study aimed to explore families’ experiences of epilepsy and KDT. Methods: Parents of a child aged ≤ 18 years with epilepsy, currently or recently treated with KDT, were recruited from the UK and internationally via UK Ketogenic Diet (KD) centres, charities, and social media. Semi-structured interviews were audio recorded, transcribed verbatim, anonymised, coded using Nvivo (V12), and inductive thematic analysis undertaken. Results : Twenty-one parents participated. Four themes and 12 subthemes emerged: 1. ‘Epilepsy is all consuming’ explored the impact of epilepsy on the family. 2. ‘KD provides a window to new opportunities’ explores the motivators for KDT and positive outcomes. 3. ‘The reality of KD’ explores day to day life and how families adapt to KD. 4. ‘Looking to the future’ explores the factors that may make KD easier for families. All were glad their child trialled KD, even when less successful. The importance of a support network including family, friends, charity organisations and the KD team was evident across all themes. Conclusion s: We conclude with five recommendations to help support families in their management of KDT; Improved access to KDT and transition to adult services, access to quality education and support, enhanced variety of KD foods, regular social education and finally consideration of peer mentoring.


Introduction
.5 Ketogenic diet therapy (KDT) can offer hope to families when anti-seizure medications (ASMs), surgery or vagus nerve stimulation have failed or are not feasible.It is an effective treatment for children with drug-resistant epilepsy leading to improved seizure control [6][7][8][9] and cognition. 10However, insufficient attention has been paid to how KDT impacts on daily life for families.It requires substantial changes in routine and dietary habits, even for more liberal diets such as the modified KD.Parents or carers lead the preparation and management of KDT including weighing and measuring foods, planning and preparing meals, monitoring ketosis and outcomes.This role offers parents a sense of control and involvement in their child's care, however the extra workload may create additional stresses and challenges for the family.This study explores the experiences of families using three different types of KDT; modified, classical and MCT KD.Collectively they have the aim of establishing ketosis and optimising clinical outcomes so all will be referred to as KDT.
As early as the 1920s, 11,12,13 parents were recognised as playing an essential role in KDT management.Yet little is known about their experiences and perspectives regarding the impact of KDT on their child and wider family.Family life is busy and anecdotally many parents report feeling overwhelmed and daunted when introducing KDT.Relatively few studies have examined parent experiences and views during this time.Williams, 14 together with three other parents shared their child's story of epilepsy and KDT.They recalled the despair of witnessing their child seize uncontrollably, the difficulties of accessing KDT, and the anxiety they felt when weaning from KDT after years of successful treatment.The accounts provide helpful insights into some key themes for families, but lack depth owing to their short narrative nature.More recently, parents reported stress as the biggest contributor to their emotional or mental health and well-being.However, this was attributed to their child's overall health and not just as a result KD. 15 Webster 16,17 investigated the experiences of parents and siblings with childhood epilepsy and with Gabe, 18 examined the identities of parents when using KDT for their children.Parents were able to maintain their identity as good parents by medicalising KD and treating food as medicine, despite the restrictions KD imposed on their child.

Objective and significance
This study aimed to build on these earlier findings by conducting in depth interviews with parents to broaden understanding of the impact of epilepsy and KDT, providing insight into parents and families' experiences.Our ability to provide families with appropriate support will be enhanced with a deeper understanding of their experiences from diagnosis through to the management of KDT.

Methods
This qualitative descriptive study was carried out as part of the development of a core outcome set for childhood epilepsy treated with KDT, 19,20 registered with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative 21 and the study protocol published. 22 applied an interpretive descriptive approach to explore families' experiences of treating epilepsy with KDT.Interpretive description departs from other typical qualitative descriptive approaches as researchers interpret the data rather than simply describing it, understanding the participants views and experiences and situating the findings within existing research and clinical knowledge. 23The researcher's technical knowledge and clinical experiences are a major source of insight, used as a valuable instrument in the research rather than a bias as is often thought to be the case. 24The study fulfils key criteria for quality in qualitative research as defined by the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist (Appendix 1). 25

Sampling and recruitment
Participants were eligible if they were a parent or carer to a child aged 0-18 years with drugresistant epilepsy treated with KDT or had weaned from KD in the past year, and were English speaking.Children with co-morbidities were not excluded.Maximum variation sampling strategies were employed to ensure optimal diversity in terms of the following characteristics: epilepsy diagnosis, age, home country, type and duration of KDT and response to treatment with KDT.
Participants were recruited from across the UK and internationally from three sources using social media posts, flyers, posters and health professional's invitations: 1. Nine UK KDT centres (UK participants) 2. Charities: Matthew's Friends, Young Epilepsy, Epilepsy Action, (UK and international participants) 3. Epilepsythe Ketogenic Way: a family support group on Facebook (UK and international participants)

Data generation
Written consent was taken prior to the interviews and participants were reminded that they could stop the interview or withdraw from the study at any point.Interviews occurred between January and June 2020 with a median duration of 72 minutes (35-131 minutes) either online, via telephone or in person, conducted by JC, a registered dietitian and doctoral researcher with approximately 12 years' experience with KDT.This may have increased the risk of observer basis, however this was mitigated by ensuring the wider research team and study advisory group were consulted in the planning of the interview schedule.Parents hopes and expectations of KDT, daily experiences, outcomes of treatment and strategies to manage KDT were explored using a semi-structured interview with a range of open questions to facilitate parent led discussion and ensuring consistency in the core questions asked while allowing individual views and perspectives to be expressed.(Table 1).Demographic data was collected (table 2).Participants were aware that the interviewer had worked as a ketogenic dietitian but was speaking to them in a research capacity, in pursuit of a PhD and no participant was or had been treated in the past by the interviewer.A reflective research diary was used by the researcher to document thoughts and findings post interview to support later analysis.

Data analysis
Participants were anonymised with a number, prefixed with FP (female participant) or MP (male).Interviews were audio-recorded, professionally transcribed (intelligent verbatim transcription), and uploaded to NVivo 12 (QSR International, Burlington, US) for analysis.The transcripts and audio recordings were reviewed several times to become immersed in the data, 26,27 gaining understanding and insight into the context of the discussion.Thematic analysis was undertaken to investigate the detailed contextual descriptions of families' experiences. 28ta was minimally theorised, providing an account of the experiences of families, what it meant to them, what they think and believe.An inductive approach to coding was adopted, deriving codes that reflected concepts emerging from the data.Initial coding and identification of early themes was performed by JC and then further refined through regular review and discussion with TP (an experienced qualitative researcher).The final themes were agreed by all authors.

Patient and Public Involvement and Engagement (PPIE)
Two parent partner co-investigators (EW, VA) who had personal experience with epilepsy and KDT joined the research team.In addition to their experience as parents, they also supported other families with KDT at Matthew's Friends, where they served as trustees.During an early patient and public involvement consultation, parents of children treated with KDT emphasised that time constraints and competing demands would pose the greatest challenges for participating parents.Interviews were therefore offered seven days a week from early to late, via telephone, video call or in-person visit to the parent's home (UK only).

Ethical approval
Ethical approval was granted by the National Health Service Health Research Authority (London-Surrey Research Ethics Committee, reference 19/LO/1680).

Sample characteristics
Thirty-eight parents registered their interest to take part and 21 parents were recruited and interviewed (19 individuals and one couple), representing 21 children as one mother had two children following a KD.No participants withdrew.Of the 17 participants not recruited, four were unable to participate owing to; hospitalisation, family bereavement, Coronavirus pandemic pressures and a response lost in junk folder.Two participants were ineligible owing to age or duration weaned from KD. Eleven were lost to follow up.
The modified ketogenic diet was most often used (N=13), followed by the classical KD (N=6) and medium chain triglyceride KD (N=1), all orally fed except for one child having top up gastrostomy feeds.Children (67% male, 34% female) ranged in age from 2-17 years (median 8yrs 7mths) and had trialled between one to seven antiseizure medications (median 4) prior to commencing KD therapy.The duration of KD treatment ranged from 4 months to over 5 years (median 1yr 10mths), during which nine children achieved complete seizure freedom and the remaining 12 experienced seizure reduction.The precise percentage reduction in seizure frequency was hard to quantify, but we estimate based on parental reports that four children experienced less than a 50% reduction, while the remaining eight children saw a reduction of 50% or more.
Most participants lived in the UK (N=15).International participants were recruited from New Zealand (N=2), Australia (N=2), America (N=1) and Ireland (N=1).Advertising by charities on social media and in a closed parents' forum proved to be the most successful recruitment strategies (N=17).Table 2 summarises demographic data for parents and children together with treatment characteristics.

Thematic summary
Thematic analysis identified four broad themes and 12 sub-themes, mapped in Table 3 together with illustrative codes and quotes.A narrative overview will follow of the journey families face from diagnosis of epilepsy, accessing KDT, managing daily life on KDT and finally how KDT might be made easier for families.

Theme 1: Epilepsy is all consuming
This theme explores the impact of drug-resistant epilepsy on the family, the uncertainty and their fight to access KDT.All parents described the all-consuming nature of their child's clinical condition and the difficulties the family faced.

Impact of epilepsy on the family
Parents recalled first seizures, initial diagnosis, and the 'spiral' that followed as they struggled to come to terms with and navigate their family's new reality.Watching their child seize regularly was 'scary, devastating, worrying, and exhausting'.Parents physical health, mental health and wellbeing were affected with many struggling to sleep (quote 1).Work and careers were often affected, especially for mothers who took career breaks, worked part-time or left their job to care for their child.
Epilepsy affected children's physical health, cognitive development and ability to learn, social skills, and Quality of life (QoL) in many ways (quote 2).Parents' explanations of what constitutes a good QoL varied, but FP18 described it as 'a normal type of life or being able to do activities of daily living'.It was felt children were missing the opportunity to participate in everyday life because of experiencing uncontrolled seizures on a regular basis.
Parents had strong concerns about the adverse effects of ASMs with all but one describing the side effects children experienced.Cognitive function, appetite, mood, behaviour, sleep, and mental health were affected, with one child experiencing suicidal thoughts.Children were dazed and disengaged, often referred to as being in a zombie-like state or experiencing brain fog (quote 3).It is important to interpret this data with caution as these are parent observations over prolonged periods of time.However, it provides insight to the breadth of adverse effects that children receiving polytherapy experienced.It was difficult to ascertain if the adverse effects were solely attributable to epilepsy, ASMs or possibly a combination of both.Nevertheless, parents were highly motivated to wean their children from ASMs in an effort to reduce symptoms.Over half of parents interviewed referred to their child's siblings and how epilepsy had negatively affected them.There was a general sense of siblings having to be more responsible and watch out for their brother or sister with epilepsy.This support was often invaluable for parents, but it created additional worry that they were neglecting their children by not paying them enough attention or expecting too much of them (quote 4).

Uncertainty of epilepsy
Parents faced many uncertainties, a constant unknown that manifested itself in day-to-day life.There was a sense of grieving for what might have been in the future, as it became clear that life would not turn out as planned (quote 5).They searched for answers and solutions to identify their child's diagnosis and potential treatments.As one mother (FP8) put it, she was 'a mother on a mission.'This drive to find the answer may have been a coping strategy to address a sense of helplessness, to bring some order to the uncertainty faced.

Fight for my child
Almost half of parents described how they had to initiate a discussion about KDT with their child's paediatrician or neurologist.Some managed to access KDT quite quickly but many parents reported the fight they faced for their child to access KDT (quote 6).

Theme 2: Opening the window to new opportunities'
This theme explores parents' motivations for trialling KDT, the positive results their children experienced, and the impact these outcomes have had on their families.Drug-resistant epilepsy can bring feelings of frustration, uncertainty, and helplessness when ASMs fail to control seizures.However, KDT offered parents hope and the opportunity to possibly regain some control in the management of their child's epilepsy.One mother (FP12) captured the essence of this theme when she described KDT as 'opening the window': it was providing her son with the opportunity to unlock his potential and that offered her hope for the future.

Hopes and expectations of trialling ketogenic diet therapy
Several factors influenced parental expectations, including the severity of the epilepsy, associated comorbidities, and timing of KDT during the treatment pathway.Parents expectations can be broadly grouped into seizure related and non-seizure related outcomes.Most participants hoped for improvement in seizure control.They also hoped for reductions in dosage and number of ASMs, developmental and cognitive gains, improved social and emotional functioning and overall QoL (quote 7).Most parents felt their expectations of KDT were met or exceeded, however two families were disappointed with the level of seizure control gained.

No longer a passenger
A strong subtheme was the need parents felt to take an active role in managing their child's epilepsy and to gain control over their situation (quote 8).KDT is a medical diet with potential to cause side effects.Yet, parents derived satisfaction from the knowledge that the diet was 'just food', and not an additional medication.Food in essence was becoming medicine for their child.KDT is a significant undertaking, even when highly motivated and the responsibility of preparing every meal and snack correctly can be daunting.However, there was a sense of accomplishment and pride among parents when they felt they were mastering KDT.Likely, their self-efficacy was improving, as their confidence and skill grew.This enhanced their sense of control of their situation.However, with that control comes additional pressure to 'get it right'.While the uncertainty of drug-resistant epilepsy may have improved, everyday life was more complex which may have added to the stress and pressure parents felt.

Benefits of ketogenic diet therapy
The positive impacts of KDT can be divided into seizure-related and non-seizure-related outcomes, although they are often interrelated.It was common for parents to share the sentiment: 'I got my child back' when asked if their expectations of KDT were met (quote 9).The benefits were undoubtedly positive for the child with drug-resistant epilepsy, but also for the wider family (quote 10).All children experienced a reduction in seizure frequency, while nine (42%) achieved complete seizure freedom.Achieving seizure freedom was described as 'a dream come through' as it positively impacted upon other outcomes.Non-seizurerelated outcomes improved including behaviour, alertness and concentration.Children were described as being more clear headed and engaged at home, when interacting with siblings and during school activities (quote 11).Friends, health professionals and teachers noticed the changes which parents found reassuring and rewarding, positively reinforcing their efforts with KDT.

Theme 3: The reality of ketogenic diet therapy
Although KDT can result in positive outcomes for families, there are challenges in the daily management, which are explored in this theme together with strategies parents used to overcome these (quote 12).

Ketogenic diet therapy can be challenging
A commonly held view was that KDT is time consuming, rigid and inflexible, especially in the early months when there is so much new information to take in.Some participants experienced additional stress, pressure, and anxiety during this time.
However, not all experienced challenges, a small minority were surprised at how well they adapted to KDT and attributed this to their child being younger and/or compliant.Few parents reported adverse effects associated with KDT.Parents were motivated to overcome challenges and make the necessary sacrifices to maintain a KD for their child (quote 13).Ultimately, they felt it worthwhile and the same was true for parents whose child had achieved some improvement in seizure control and complete seizure freedom (quote 14).

The evolving KD mindset
Over the course of interviews, 'the evolving KD mindset' emerged as a subtheme, exploring how parents' mindsets changed to effectively manage KDT.By doing so, parents were able to achieve a greater sense of control over their child's epilepsy management, a concept closely associated with the subtheme "no longer a passenger".It appears that parents felt they were on a journey with KDT, initially trepidatious but optimistic, gradually developing their confidence and skills, overcoming challenges along the way.Parents were faced with new ways of thinking about food, the ingrained principles of a low-fat healthy diet no longer applied and they 'picked their battles' with regard to food choices.Many described how they threw themselves into the KDT education and preparation sessions and how over time the KDT became easier.As parents became more comfortable with KDT, their confidence to try new things improved, such as eating out for the first time and going on holidays (quote 15).Firsts such as these were extremely formative, as they contributed to their sense of achievement and increased self-efficacy, which in turn enhanced their confidence and ease with KDT.

A support network is crucial
A support network was commonly viewed as crucial to help families cope with KDT.This network included family members, friends, carers, families with shared experiences, KD charities and the keto multi-disciplinary team.Some of the most valuable support was provided by those who listened and made an effort to understand and assist the family.Connections with families with shared experiences were particularly valued and these were facilitated by keto charities via online forums and groups or social events like coffee mornings or charities and medical nutrition companies facilitating keto cookery days (quote 16).
Parents welcomed the support and motivation they received from their keto team and in particular; timely responses to their queries, monitoring the risk of adverse effects and bespoke recipes and meal plans (quote 17).Interestingly, parents valued dietitians attempts to understand their experience by trailing the KD.However, issues arose when parent's felt unheard, had to wait for long periods for follow up or were provided with recipes or meal plans which they felt would not work for their child.

Theme 4: Looking to the future
Having gained a deeper understanding of KDT's impact on families, theme four aimed to identify factors that may make KDT more manageable for families.In particular, how families could be more effectively supported with KDT and inclusion of parental suggestions into recommendations for the keto community to consider.During the interviews, parents were asked to envision what it would be like if they had a magic wand that would make KD easier.They shared experiences, ideas, and strategies, which were analysed and grouped thematically.

Enhanced awareness and understanding of ketogenic diet therapy
Some families were not aware of KDT prior to their neurology team suggesting it, which raised the concern for some that if they had not been informed, their child might never have accessed KDT.As one mother stated 'it's about empowering parents with the knowledge that it's out there' (FP13).A number of families experienced significant delays in the initiation of KDT, as illustrated by the median number of four trialled ASMs, which is double that suggested in international expert group recommendations. 26Several parents expressed frustration, anger, sadness, and disappointment regarding what could have been achieved had KDT been initiated earlier.It was hoped improved awareness and understanding of KDT among paediatricians, epilepsy nurses, and neurologists would result in fewer families having to wait so long for a referral to a specialist keto team.

Variety and access to ketogenic foods
Time was one of the greatest challenges of KDT raised by parents; the time required to plan and calculate recipes, shop for special ingredients, and prepare meals.Consequently, parents would welcome improvements in the convenience of KDT, including a greater variety of prescription medical nutrition products and store-bought options (quote 19).

Support and education
This subtheme examines parent perspectives on what constitutes quality support and education for families.There is significant overlap with the earlier subtheme 'a support network is crucial' particularly in relation to the support that KD charities and the keto team provide.Parents described the practical and emotional support that charities such as Matthew's Friends, Daisy Garland, The Charlie Foundation, and Young Epilepsy provide.There was a recurring theme regarding the importance of supportive health professionals who listened and worked collaboratively with parents.They emphasised the importance of a holistic approach to supporting families to access and manage KDT, as well as ensuring that a variety of optimal outcomes are considered.FP8 described this as 'looking at the whole child and how everything impacts'.FP19 and MP2 expanded on this by encouraging health professionals 'to look beyond the numbers'.
Parents expressed they enjoyed and valued keto cookery days where they met with an experienced keto chef, other families, and a dietitian.The sessions could be considered a form of social education where parents could practice recipes, receive hints and tips and share their experiences with others in a relaxed learning environment (quote 20).When asked if a peer support system like a mentor or 'keto buddy' would be helpful, many parents agreed.It was felt that they could share their real insights as families who are living KDT (quote 21).Interviewees, however, emphasised the challenges the initiative might face, such as the need for experienced mentors at each stage of KDT and the increased workload for mentors.
The need for support from the keto team extends to the final stage of KDT, that is weaning from the diet and returning to a more typical, standard dietary intake.It is common to consider this after two years of treatment with KDT, 29 and usually the positive outcomes gained on KD are sustained after returning to a normal diet.However, the timing should be determined by the keto team and the family, rather than the family feeling pressured to discontinue the KD.Parents understandably often experience mixed feelings and emotions; it can be challenging to consider stopping KDT after successful treatment and a range of positive outcomes have been achieved (quote 22).

Recommendations to support families with the management of ketogenic diet therapy
Parents perspectives have helped to shape the five recommendations presented in Table 4. Implementation of these recommendations is proposed through a number of actions and the stakeholders who may be best positioned to assist are identified.

Discussion
This qualitative descriptive study aimed to explore how families experienced epilepsy and KDT as told by parents.Their accounts revealed four main themes and twelve subthemes, spanning the period from the diagnosis of epilepsy to the use of KDT as a therapeutic intervention and finally, weaning from KDT.The findings demonstrate that KDT can provide parents with a sense of control over an unpredictable situation, and when successful offers significant benefits to the child and family.
While much is understood about the experiences of families with epilepsy, only one other research group has conducted similar qualitative research addressing epilepsy and KDT. 18,30However, this was from a sociological perspective focused on the meaning of food within the family and did not address the practical aspects of KDT.Consequently, this study builds upon the work of Webster and Gabe by exploring in greater detail, the practicalities of KDT, benefits for families and potential improvements to future KDT management.Drug-resistant epilepsy was characterised by persistent and uncontrolled seizures, an unstable condition that created uncertainty for parents.Webster 17 described this as 'a cycle of uncertainty' marked by day-to-day uncertainty, future uncertainty, and symptomatic uncertainty.Several examples were similarly reported by parents in this present study.They worried about their child's diagnosis, treatment options, when the next seizure would occur and what the future might hold.Unsurprisingly, parents of children with epilepsy, particularly mothers 31 have higher rates of stress, anxiety and depression owing to the additional burden of care associated with having a child with a complex illness. 4There is often no respite from the all-consuming and unpredictable nature of their child's epilepsy.
As parents became aware that their child's future would not unfold as they anticipated, they described grieving the loss of what might have been.Dyson and Fewell 32 suggested that parents are dealing with the inevitable loss of the image of an 'ideal child'.The diagnosis of epilepsy likely intensifies these feelings and may result in a period of mourning, described as a state of chronic sorrow.This can be a long-term, cyclical sadness or grief experienced by parents and caregivers in response to a situation with no predictable end, 33,34 independent of epilepsy severity and other comorbid conditions. 35To help manage feelings of chronic sorrow, parents need to develop ways of coping with their child's epilepsy.
The subtheme 'no longer a passenger' illustrated how KDT provided a problem-focused coping strategy.It offered hope that treatment could be successful and gave parents the opportunity to take the lead in the treatment's provision.Parents with more positive attitudes towards epilepsy have been found to use more positive coping behaviours like seeking social support, strengthening family relationships and being optimistic about life in general. 36DT may help parents to have a more positive attitude and optimism about their children's future.While they acknowledged that it would be different from the normalcy they had originally anticipated, there remained positive outcomes.With time, parents' confidence grew, and pride in their ability to attain the expertise and skills required to cope with epilepsy and KD. 37This was evident in the subtheme 'the evolving KD mindset'.
Children had been treated with a median of four ASMs (one to seven) prior to referral for KDT, in spite of the recommendation that KDT is trialled after two failed ASMs, 29 so most families had experienced drug-resistant epilepsy for an extended period.As a result of the delay in access to KDT, parents experienced feelings of helplessness, anger, and frustration, similar to those shared by four families when recalling their experiences with KDT. 14 Parents questioned why KDT had not been offered earlier and how different their child's condition might have been.It is likely that parents experience multiple emotions during those first consultations, so it is essential that keto teams listen to families' prior experiences and acknowledge these emotions.The needs of parents should be considered, as well as the support they may require to adapt to new coping strategies.In the same way, parents need support to help guide their expectations and hopes regarding KDT to address any misconceptions that may compound existing feelings of helplessness.As health professionals, it is our responsibility to take the time to explore individual hopes and expectations with parents.
The goal of KDT for childhood epilepsy is to improve a broad range of seizure and nonseizure-related symptoms and, ultimately, to improve global QoL for children by enabling them to build upon their existing strengths.The theme 'opening the window to new opportunities' demonstrated ways in which children benefited from KDT, which included learning new skills, engaging in activities, and building and maintaining social relationships.In a small study of 12 parents, an unvalidated tool was used to explore their expectations regarding KDT and what would constitute improved QoL for them and their child. 2The outcomes which led to improved overall QoL for children and parents are similar to those described in our study.These included the child being happy and smiling again, improved alertness and recognition of those around them, developmental progress, reduced seizures, reduced ASMs and toilet training.More recently, an online survey distributed via social media platforms assessed 192 parents perspectives of KDT.The median score for QoL was 9 on a scale of 0-10 (10 being much improved), which suggests parents felt their children's QoL was much improved when treated with KDT. 38Although, this study was limited by the lack of a comparison baseline score of QoL prior to KD.Given the reported improvements in QoL it is not surprising that treatment with KDT has been conceptualised as a 'saviour' for children, particularly for those who experienced a reduction in seizures and emergency hospital admissions. 30Similarly, parents in this present study described the sense of 'getting their child back'.Despite the challenges, they were able to establish a sense of normalcy for their child and family through KDT.Interestingly though, it has been observed that 'the goalposts can shift' over time where parents sub-consciously increase their expectations of KDT, overlooking the positive achievements gained. 2 It is important that keto teams explore these evolving expectations and encourage parents to reflect upon the gains achieved with KDT to support ongoing motivation.
Woodgate et al. 39 describe a state of intense parenting, where parents of children with complex care needs took on more roles than parents of healthy children and they had to work more intensely at these roles.Theme 1 'epilepsy is all consuming' illustrated how parental health and well-being are often deprioritised as they focus on caring for their child with complex needs, coping with uncertainty, anxiety, exhaustion and frustration, findings that have also been echoed by Harden et al. 3 According to Sarlo and Holton's survey, 38 parents rated KDT as somewhat to very challenging on a scale of 0-10, with a median score of 7.Moreover, 99% of respondents reported experiencing more than one diet-related difficulty.Many of the challenges reported were similar to those found in the theme 'the reality of KD therapy' including a lack of clinical support, a lack of time, family stress, restrictions on social outings, cost, and caregiver stress.
There is a great deal of emphasis on the potential adverse effects of KDT by health professionals, and these are monitored regularly via bloods and imaging.Yet, it was interesting how little emphasis parents placed on these when discussing the challenges associated with KDT.Perhaps parents are reassured by the keto team's close monitoring for adverse effects, and in a sense, they delegate that responsibility to them.In contrast, parents expressed strong concerns about the range of adverse effects associated with ASMs, and some felt their keto team dismissed these concerns.After observing positive results of KDT, parents were often eager to reduce the dose and number of ASMs and were frustrated if their keto team was cautious.This has implications for how health professionals discuss expectations of KDT with families, and their willingness to attempt to wean an ASM.KDT should be discussed as a partnership with ASMs and not a substitute.This is important in light of the fact that 86% of a cohort of 232 children treated with KDT remained on at least one ASM during and after treatment with KDT. 40Anecdotally, there is sometimes a misconception among health professionals that children must be seizure free before attempting to reduce ASMs.This is not the case 29,40 and working with families to determine the best timing and order for attempting ASM weaning may strengthen the relationship with their keto team.
While KDT assisted families in managing some of the uncertainties associated with epilepsy, the final theme 'looking to the future' revealed that many parents expressed concern and fear that weaning from KDT would worsen seizure control.It was difficult for parents to 'let go' of this successful treatment.By initiating open conversations and exploring the potential benefits and risks of weaning from KDT, health professionals can assist patients in managing this stress and worry.Few studies have continued to follow patients up post KDT, but those that have suggest that 75-80% of children who are seizure free on KDT will sustain this once KDT is discontinued. 41,42Similarly, 75% of children who achieved a 50% reduction in seizure frequency maintained these benefits when weaned. 42These encouraging results should provide reassurance to families considering weaning from KDT.
International recruitment was a strength of this study, with five participants recruited from outside the UK.The use of NVivo software ensured that the stages of analysis were retained, and a clear trail could be mapped through these.There are some limitations to this study.Due to time and budgetary constraints, the study was conducted only in English, limiting international participation to English speakers.The decision to rely on parental proxy reporting of patient experience was made in recognition that many children with cognitive impairments would not be able to participate.Although recruitment strategies varied, our sample included mainly mothers, an issue not unique to our study that perhaps represents the parent who has the most to say on the topic.The majority of children were consuming their KD orally, with the exception of one child who received top-up enteral feeds through a gastrostomy tube.Consequently, the experiences represent those who have managed a KD orally.All children experienced some degree of seizure reduction and nine achieved seizure freedom.Two parents were disappointed with the outcome of KDT, so overall they were arguably a motivated group, keen to share their views on outcomes and experiences of epilepsy and KDT.While there is potential for bias in their responses, their viewpoints are generalisable to the population this study represents; children with epilepsy who trial and continue KDT.
The sampling frame guiding recruitment considered the child's epilepsy diagnosis but omitted developmental status and learning difficulties.Similarly, we omitted to gather demographic data for caregivers.In hindsight, collation of this data may have provided further insights to the study population.he use of ASMs and associated adverse effects was an emotive topic for parents so it would have been beneficial to have more data on the use of ASMs.Firstly, the perceived adverse effects experienced with each ASM and secondly if attempts were made to wean from ASMs and the outcome of this.

Conclusion
Our study provides deep and meaningful insights into families' experiences of epilepsy and KDT.Although KDT presents challenges, parents believe the benefits for their children outweigh the difficulties.KDT can provide a problem focussed coping strategy for parents and holistic family centred care from the keto team is essential to support them with this.Parents would welcome improved access to KDT and transition to adult services, access to quality education and support, enhanced variety of KD foods, regular social education and finally consideration of peer mentoring.
The next phase of this programme of research is to develop a bespoke parent reported quality of life measure to address the comprehensive needs of children and young people with complex epilepsy undergoing KDT treatment.The findings from this current study will guide the development of this measure, ensuring it is clinically relevant, family-centred and fit for purpose in ketogenic clinics and research settings.Please start by telling me the story of your child's epilepsy

2.
Could you tell me how your child's epilepsy has affected you and your family?

3.
Thinking back to before your child started ketogenic diet, can you tell me what your expectations or hopes of the diet were?

4.
Were those expectations delivered?(what has changed with ketogenic diet?)

5.
Can I ask, how did that make you feel?

6.
Has that changed -do you still feel that way now?

7.
As you are aware we are interested in the results or outcomes that parents think are important to assess in clinics and research, what results do you think are important when using the KD?

8.
If you were asked to prioritise, what would be the most important result or outcome?

9.
Can you tell me about the day-to-day management of the KD?

10.
What might help to make KD easier for families?

11.
Do you think a buddy or mentoring programme would be helpful where parents support each other with KD?   Keto teams to take a holistic patient-centred approach to care, considering a variety of seizure and non-seizure related outcomes of KDT. Connect families with KD charities and the range of excellent resources and services they offer. Provide emotional support for parents, especially when approaching the time to discontinue KDT.
 Keto teams  KD charities 3. Children and their families should have opportunities for social education and learning  Consider the ability to offer group education sessions in the preparatory phases of KDT where families can meet and learn together. Offer opportunities for families to meet and learn together in an informal setting such as keto cookery sessions, coffee mornings or informal virtual meetings.
 Keto teams  KD charities  Medical nutrition companies 4. Explore the feasibility, costs and perceived need to develop a peer mentoring programme for parents new to KDT to receive support from experienced parents  Further explore the perceived need and feasibility of a peer mentoring programme via a focus group with parents and professionals.
 CORE-KDT research team  KD charities 5. Expand the range of ketogenic foods, both on prescription and store-bought to improve the convenience of KDT for children and families.
 Medical nutrition companies to continue to broaden the range of keto products available. It is challenging to access and influence the wider food industry but keto teams and KD charities to be responsive in supporting parents to identify suitable keto friendly foods. 

Table 1 -
Semi structured interview schedule

Table 2 -
Participant characteristics and demographic data

Table 3 -
Mapping of themes, subthemes, codes and illustrative quotes

Table 4 -
Recommendations to support families with the management of ketogenic diet

Table 3 . Mapping of themes, subthemes, codes and illustrative quotes
'I guess if you asked what the impact of seizures on our life was, it was our life for quite a number of years.That's what we read and that's what we did, and it was all based around the children.My husband and I didn't really get a look in.Plus, we're at the hospital every two weeks with appointments.We worked full time throughout that as well, both of us, so it was quite a lot going in in the house.' (FP10) 'I don't know how to quantify it really…he's been diagnosed so long the seizures themselves….don't really bother us so much, it's the learning disabilities and the things that come with it that do… A lot of what comes with it, the learning disability impacts absolutely everything.' (FP7) '..You start looking at quality of life as well, because you're doing all these medications, you're going up, you're being advised perhaps if you want to go up, go up a bit higher, you want to go up to this.So, you're going up and you're seeing the impact in the behaviour, the education.Just everything really, quality of life.But they're wiped out and they're a bit of a zombie.That's not fair either.' (FP6) two days, it was like, oh my god, he's seizure free… It was just amazing, so had our old X back.His personality went back to what it was when he was about six, and we just saw the glimpse of the X he used to be'.(FP10) 'Be that little bit proud, yes, you're actually doing stuff now.. it's almost opening the window up to him learning those new skills that he never had that possibility before.….theKD has just given me a bigger window of hope for there's still options out there for him.'(FP12) I wasn't keen, they've pushed more than I have.I think it's taken me two years to get to okay, let's give it a go, put it that way… I'm terrified and excited at the same time.It would very much be nice to be able to just go out for a meal with the family, to have a social experience…Yes, I am nervous about it, I'm very, very nervous that when we get to a point where he's off it [KD] completely and we start introducing foods back that he's going to go back to how he was.I am at the point now where I don't think I can do that again, I really don't think I can do that again.So that scares me.I'm hoping, because you are supposed to stay on it for two years and then the benefits are supposed to stay and that's it, I'm hoping that that's going to be the case."(FP7) 'Socially it's awkward, financially it's a bit hmm, shopping's a bit hmm, but at the end of the day there's no chocolate bar out there that's worth going back to how he was.' (FP7) 'But the downsides are manageable and minor compared to impact… It's amazing.The diet gives you the possibility -the limitations are so minor compared to the possibility to live a normal life.I believe this is valid for kids and adults.It gives you the opportunity -the limitations are not that frightful.It gives you the opportunity to live.That's it, to live, because the other one is existence.It's not living.'(FP5)'Iattendedtwoto three cookery days, yeah just to meet other people actually who were on a diet.Because that was one of the biggest things, you feel quite isolated and nobody else really understands…so just to have that link to a few people you meet on the cookery days was really invaluable.' (FP6)'We have her[dietitian]on a pedestal because, well, wemaybe not directly, but we actually do feel like she's saved X's life, and that she's given X the opportunity to have as normal an adulthood as she could possibly have.So, yes, we kind of owe 'So to have somebody [a keto buddy or peer mentor] that -yes that's, come on, keep going, it's worth it, and we've all been there, we've all been there, you'll get through to the other side, just something like that, that actually has the experience of starting the diet and knew about the constipation, they knew about the reflux and all their

Table 4 . Recommendations to support families with the management of ketogenic diet therapy
Increase awareness of the evidence supporting KDT among non keto professionals via CPD webinars, education days, patient testimonials, local outreach and collaboration. Liaise with our colleagues in adult epilepsy services to support business case development for growth in services. Participate in initiatives that have a national and international reach in reviewing or setting epilepsy research and treatment priorities, such as consultations and evidence reviews conducted by NICE and partnership priority setting surveys.

Table 2
Medical nutrition companies  The food industry  Keto teams  KD charities 16.Description of sample What are the important characteristics of the sample?e.g.demographic data, date Data collection 17.Interview guide Were questions, prompts, guides provided by the authors?Was it pilot tested?Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.International Journal for Quality in Health Care.2007.Volume 19, Number 6: pp.349 -357