Understanding irritable bowel syndrome care: Co-create with patients and providers for diagnostic and management innovations

Abstract

BACKGROUND

A non-invasive, biomarker-based, breath analysis device is currently being developed to support the diagnosis and management of irritable bowel syndrome (IBS). Understanding existing IBS diagnostic and management processes is essential to ensure its alignment with end users’ needs and existing IBS care.

AIM

To understand IBS diagnosis and management processes and explore how a breath analysis device might integrate with care processes.

METHODS

This qualitative, explorative study comprised two research activities: (1) Desk research; and (2) Semi-structured interviews with stakeholders. Desk research sources included (grey) literature such as Dutch College of General Practitioners guidelines and the patient association website. Nineteen semi-structured interviews were performed: 11 with patients and eight with health care professionals.

RESULTS

Despite the complexity of diagnosing and managing IBS, our results provide comprehensive insight into current IBS care processes. Although health care professionals felt that they provided sufficient information and fully discussed treatment options, patients nevertheless experienced a lack of guidance, often turning to complementary medicine. Additionally, while many participants were receptive towards the idea of a breath analysis tool to support the diagnosis and management of IBS, skepticism was expressed regarding its likely diagnostic accuracy, and the risk of misdiagnosis and underdiagnosis of other gastrointestinal diseases was also mentioned.

CONCLUSION

Stakeholders expressed a need for more definitive diagnostic testing for IBS. Co-creating digital health tools based on lived experiences may improve patient outcomes and strengthen patient–provider relationships.

Key Words: Contextual inquiry; Participatory research; Co-creation; Center for eHealth Research and Disease Management roadmap; Interviews; Irritable bowel syndrome

Core Tip: This study aimed to understand current irritable bowel syndrome diagnosis and management, and through interviews with patients and healthcare professionals, explore how innovations might successfully integrate with irritable bowel syndrome care. Patients and healthcare professionals supported the development of a more definitive diagnostic tool, while remaining cautious about its accuracy and the potential for mis- and underdiagnosis. Ongoing involvement of patients and healthcare professionals is essential for successful development and implementation, ensuring usability, trust in the device’s added value, and integration into clinical workflows and patients’ lives.

INTRODUCTION

Irritable bowel syndrome (IBS) is a chronic disorder characterized by a heterogeneous clinical presentation and has a global prevalence in adults of between 5% and 35.5%[1-3]. Patients with IBS may experience abdominal cramps related to defecation, with some experiencing constipation, while others have diarrhea, a combination, or an unclassified pattern[3]. IBS has a substantial impact on patient quality of life (QoL), affecting both physical and psychological well-being[2,4]. While limited evidence is available regarding the cause(s) of IBS[5], factors involved in its pathophysiology include visceral hypersensitivity, alterations in microbiota, low-grade mucosal inflammation, gastrointestinal dysmotility, as well as psychological influences[6]. Furthermore, recent studies demonstrate strong bidirectional communication between the gut and brain via the gut-brain axis[5,7,8]. More specifically, this activates innate immune responses, leading to systemic and brain inflammation and resulting in increased vulnerability to stress and psychiatric disorders[9]. Conversely, as psychological stress can influence intestinal symptoms, IBS is therefore also classified as a functional gastrointestinal disorder[7,10,11].

Timely management of symptoms, support for lifestyle modifications, improved patient QoL, and lower direct and indirect medical and societal costs all depend on early diagnosis and identification of symptom triggers[12]. Historically, IBS has been viewed as a ‘diagnosis by exclusion’ and required lab and stool tests or a colonoscopy to rule out other gastrointestinal diseases[12]. Nowadays, there is a shift towards viewing IBS as a “positive” clinical diagnosis based on Rome IV criteria, which predominantly concern abdominal pain and stool[12,13]. In practice, it is often still necessary to exclude other gastrointestinal diseases[14-16].

The Rome IV criteria are subject to interpretation and are influenced by cultural factors[1,17,18]. Studies also report a mismatch between the Rome IV-based vs the self-reported IBS prevalence[19,20], highlighting discrepancies between patient-reported experiences and diagnostic frameworks, which may contribute to delays in care provision[20,21].

Symptom-targeting treatments such as specific diets, peppermint oil or low-dose anti-depressants, or a combination of these, reportedly lower the disease burden and improve patient QoL[15,22-24]. An example is the labor-intensive (low)-fermentable oligosaccharides disaccharides monosaccharides and polyols (FODMAP) diet in which people, with the help of a dietitian, eliminate and reintroduce FODMAP nutrients to observe effects on symptoms[25]. However, no curative medical treatment exists for IBS[21,25]. Furthermore, psychotherapeutic treatments such as cognitive behavioral therapy and hypnotherapy have shown promise in reducing symptoms[26-28].

Digital health technologies have shown potential in differentiating IBS from other inflammatory bowel diseases, and in supporting management by monitoring stress and gut motility[29-32]. However, their widespread adoption remains limited due to challenges related to data accuracy and interpretation, privacy and security, as well as overall accessibility[33]. A non-invasive, user-friendly handheld breath analysis device, which detects IBS-specific breath biomarkers, is currently being developed to support the diagnosis and management of IBS[34]. Understanding current IBS diagnostic and management processes, together with stakeholder perspectives, is essential to ensure the device meets end-user needs and integrates with existing care pathways[35]. Therefore, this study aims to achieve a comprehensive understanding of current IBS diagnostic and management processes, as well as explore if and how a breath analysis device might integrate with the IBS care process.

MATERIALS AND METHODS

Study design

Following the Center for eHealth Research and Disease Management (CeHRes) roadmap, this qualitative, explorative study represents the first phase of co-creation (i.e., contextual inquiry). Co-creation is defined as active collaboration between prospective end users and developers during the development of an innovation[36]. This study focuses on identifying stakeholders involved in IBS care, exploring their perspectives regarding IBS care, identifying barriers and facilitators of current IBS diagnostic and management processes, and assessing their views on the role of a breath analysis device. Two main research activities were undertaken to achieve these study aims: (1) Desk research; and (2) Semi-structured interviews with stakeholders.

In the Netherlands, this type of study falls outside the scope of the Medical Research Involving Human Subjects Act and as such does not require full ethical review. The study was therefore assessed by the non-Medical Research Involving Human Subjects Act review board of Leiden University Medical Center and received a declaration of no objection (Approval No. WSC-2024-49/MdW). This study is compliant with the General Data Protection Regulation and the Dutch Act on Implementation of the General Data Protection Regulation (Uitvoeringswet Algemene Verordening Gegevensbescherming). All participants provided either written or digital consent before participating in an interview.

Desk research

Desk research was conducted during February 2025 with the aims of establishing a comprehensive overview of existing IBS care, and identifying relevant stakeholders. Search queries included IBS, diagnosis, management, stakeholders, health care professionals (HCPs), clinical guidelines, and multidisciplinary care. Searches were conducted via PubMed Library, Google Scholar, and Google. Sources also included (grey) literature such as Dutch College of General Practitioners (NHG) guidelines, and the patient association website[15,37].

Interviews - recruitment and participants

We recruited Dutch-speaking individuals with either self-diagnosed or family physician (FP)-confirmed IBS, as well as HCPs working in IBS care. Self-diagnosis was deemed sufficient when participants experienced symptoms consistent with guideline-based IBS criteria[38]. Individuals with a combination of IBS and other gastrointestinal conditions were excluded. A purposive sampling method was used to ensure variety in age, sex, severity of IBS, and profession within the HCP group[39].

Participants were recruited via health care organizations and the sharing of online flyers targeting IBS patients and HCPs. Flyers were also distributed via a patient advocacy group (in Dutch: De Prikkelbare Darm Syndroom Belangenorganisatie), and via social media (Facebook, LinkedIn, Instagram). Interested participants received an information letter outlining the study objectives and procedures, including an informed consent form to read and sign before the interview.

Data collection

Nineteen semi-structured interviews were conducted using a predefined interview guide based on the CeHRes roadmap and the “exploring patients’ perception of patient-centered care at primary healthcare level framework” by Waweru et al[40]. Although few frameworks explicitly support the contextual inquiry phase of co-creation, the framework proposed by Waweru et al[40] was selected as it supports a thorough exploration of study context and helps to navigate the complex healthcare landscape of the condition under study. As this framework originally focused on patients, themes were adapted to reflect HCPs perspectives. The interview guide covered symptom onset, steps in IBS diagnosis and management, participants’ experiences regarding the care received and provided, the roles of different HCPs within these processes, and further included participants’ perspectives regarding the use of innovations - more specifically the breath analysis device.

Interviews were performed, in Dutch, between April 2025 and August 2025, and lasted between 30 minutes and 80 minutes. Interviews were conducted either online or in-person either at the participants’ home/workplace or at Leiden University Medical Center. The participants also filled out a sociodemographic questionnaire covering clinical and sociodemographic factors. Interviews were performed by Jonker W and Hogewoning E, but Mahboubian A joined five interviews in a supervisory role. Three interviews were conducted by Mahboubian A, Jonker W, and Hogewoning E individually. Interviews were conducted until data saturation was reached and no new themes emerged in either the patient or the HCP groups[41,42].

Data analysis

Descriptive analyses were conducted to summarize sociodemographic characteristics. Audio recordings were transcribed verbatim. The Waweru et al’s conceptual framework[40] and the interview guide were used to thematically analyze the data. As depicted in Figure 1, the framework consisted of three main themes: (1) Patients’ health needs and expectations; (2) Patients’ perceptions of their care experience; and (3) Patient-reported outcomes. Theme 3 additionally covered patient recommendations to improve quality of care. The framework was also examined from the HCP perspective by exploring their experiences with patients’ health needs and expectations, their views on care provided, as well as clinical patient outcomes throughout the diagnosis and management process. In addition, HCP recommendations for improving care and for the use of a breath analysis device were explored.

Figure 1 The conceptual framework for exploring patients’ perceptions of patient-centered care at the primary health care level in Uganda[40]. Citation: Waweru E, Smekens T, Orne-Gliemann J, Ssengooba F, Broerse J, Criel B. Patient perspectives on interpersonal aspects of healthcare and patient-centeredness at primary health facilities: A mixed methods study in rural Eastern Uganda. PLoS One 2020; 15: E0236524. Copyright© 2020 Waweru et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

The framework method was used to systematically analyze interviews[43]. First, the transcripts were transcribed for familiarization purposes and to identify initial patterns[44]. Second, the researchers (Mahboubian A, Jonker W, and Hogewoning E) coded two transcripts independently. Coding was performed in Atlas.ti[43]. Themes from the Waweru et al’s framework[40] were used as code groups, with subthemes as subcodes (i.e., deductive; Figure 1), while additional themes could also emerge from the data (i.e., inductive). A consensus meeting was held to review the codes, resolve discrepancies, and finalize the coding scheme (Supplementary Figure 1). Subsequently, two researchers (Jonker W and Hogewoning E) coded the remaining sixteen interviews using this scheme[45]. One interview was coded by Mahboubian A. Finally, the coded data were reviewed to identify and interpret any new themes emerging from the assigned codes. Despite some thematic overlap, the framework proved comprehensive in capturing the relevant themes for the contextual inquiry and was therefore used to structure the results. This ensured a theoretically sound analysis characterized by systematicity, comparability, transparency, and reproducibility. Where appropriate, additional themes were allowed to emerge inductively to enable a more in-depth interpretation of the findings. First, needs and expectations referred to patients’ anticipated care needs. Second, experiences and perceptions addressed how patients experienced the care received and how HCPs experienced the care provided, including emotions, satisfaction, and perceptions regarding decisions and processes. Lastly, patient-reported outcomes encompassed more concrete clinical and experienced outcomes as reported by patients and HCPs across different IBS trajectories. Although the framework proved fairly comprehensive, one additional theme emerged inductively from the data: Patient empowerment through, diagnosis acceptance, and self-management. This theme strengthened the analysis by extending the Waweru et al's framework[40] and helped contextualize findings across multiple sections of the results.

Reflexivity

The research team comprised researchers from the Netherlands with varying professional backgrounds and research experience. The researchers who conducted the interviews were all female and aged below 30, which facilitated interaction with largely young female patient participants and with HCPs. At the same time, this profile may have caused other participants (male and/or older) to feel less comfortable when discussing physical discomforts related to IBS. This may have hampered the richness of data collection. In addition, as some researchers had personal experience with IBS-related complaints, this may have supported empathy and understanding during interviews, but also required ongoing reflexivity by means of consensus discussions to minimize potential bias and data (mis)interpretation.

RESULTS

Desk research: Stakeholder identification

A stakeholder’s overview (Figure 2) was developed based on desk research. Given their prominent role in IBS care, patients, FPs, dietitians, and gastroenterologists were selected as stakeholders for interviews. During the interviews, additional potentially relevant stakeholders were identified, including orthomolecular therapists, osteopaths, homeopaths, bio-resonance therapists, an acupuncturist, and a pediatrician specialized in IBS hypnotherapy (Figure 2). These stakeholders were subsequently approached for participation. However, except for the pediatrician, this did not result in any interviews due to varying reasons such as unwillingness to participate.

Figure 2 Overview of the identified stakeholders in the irritable bowel syndrome care process. These descriptions were based on findings from the interviews, Dutch College of Family Physician guidelines, and the irritable bowel syndrome patient advocacy organization webpage. CBT: Cognitive behavioral therapy; HCPs: Health care professionals; FODMAP: Fermentable oligosaccharides disaccharides monosaccharides and polyols; FP: Family physician; IBS: Irritable bowel syndrome.

IBS care process

Supplementary Figure 2 visualizes the patients’ journey from initial symptoms to management using the metro map method[46], which was developed based on the desk research (e.g., NHG guidelines) and preliminary interview results. Each step includes a summary of actions, experienced barriers and facilitators, and possible touchpoints (i.e., moments of interaction) with an innovation such as the breath analysis device, including its anticipated added value. These individual elements are discussed in the following result sections.

Participant characteristics

Eleven patients and eight HCPs were included in this study. Participants’ characteristics are summarized in Table 1.

Table 1 Socio-demographic characteristics of all participants, n (%)/mean ± SD.

Characteristics	Patients	HCPs
n	11	8
Age, (range)	35.2 ± 13.9	45 ± 16.9
Female sex	8 (72.7)	7 (87.5)
Years of IBS diagnosis	12.3 ± 10.5
Type of IBS classification
IBS-M	4 (36.4)
IBS-U	1 (9.1)
IBS-C	2 (18.2)
IBS-D	1 (9.1)
Unknown	3 (27.3)
Education patients
Senior general secondary education or pre-university education	3 (27.3)
Secondary vocational education	1 (9.1)
University of applied sciences	4 (36.4)
University	3 (27.3)
Employment status
Incapacitated for work due to IBS	1 (9.1)
Part-time job	4 (36.4)
Full-time job	2 (18.2)
Student	4 (36.4)
Profession
Family physician		3 (37.5)
Dietitian		3 (37.5)
Gastroenterologist		1 (12.5)
Pediatrician		1 (12.5)
Work experience (years)		17 ± 15.3
Experience in IBS-care (years)		13.6 ± 12.1

IBS: Irritable bowel syndrome; IBS-M: Irritable bowel syndrome mixed subtype; IBS-U: Irritable bowel syndrome unsubtyped; IBS-C: Irritable bowel syndrome constipation subtype; IBS-D: Irritable bowel syndrome diarrhea subtype; HCP: Health care professional.

IBS diagnostic process

Health needs and expectations - understanding of health, values and preferences: Despite HCPs describing the onset of IBS as clear and identifiable, patients reported difficulty in identifying the exact onset of their symptoms. Patients reported initially neglecting their symptoms and described their attempts to cope. Overall, patients reported experiences of symptom flaring as a reason to suspect a chronic condition. Furthermore, they noted that symptom fluctuations were multifactorial, with stress, physical activity, and specific dietary combinations highlighted (quote 1). Patients often decided to visit the FP or dietitian once symptoms significantly affected their lives. By visiting an HCP, they expected to obtain greater insight regarding their health status, obtain more clarity, and a definitive diagnosis explaining their symptoms (quote 2). The Dutch guidelines advise asking questions regarding medical history, onset of symptoms, psychological symptoms, influence of diet, and stress. In addition, physical examination is performed, additional laboratory tests are considered and discussed with the patients, and information is provided about the nature, course, and treatment of IBS. None of the patient participants explicitly mentioned being aware of the Dutch IBS guidelines before visiting the HCP, suggesting a potential mismatch between professionals’ guideline-based routine and patient expectations.

Perceptions and care experiences - exploring health and patient-HCP interactions: Both patients and HCPs experienced the diagnostic process as challenging, since there is no clear cause of IBS. In line with the NHG guideline, patients and HCPs confirmed that IBS diagnosis is often based on clinical examination and exclusion of other diseases such as inflammatory bowel disease (e.g., Crohn’s disease), colon cancer, or celiac disease. Although desk research showed that a positive clinical diagnosis based on the Rome IV criteria suffices in the IBS diagnostic process, FPs noted that these criteria are often too broad and subjective for a clear diagnosis, and hence not applicable to all IBS patients. To provide patients with more certainty, FPs frequently performed fecal and blood tests to rule out other gastrointestinal diseases (quote 3). The patient participants underwent the following diagnostic examinations: Blood test (n = 11, 100%), fecal test (n = 10, 90.9%), colonoscopy (n = 4, 36.4%), ultrasound (n = 3, 27.3%), or computed tomography scan (n = 2, 18.2%). The majority of patients eventually received an official IBS diagnosis.

Some HCPs perceived diagnostic acceptance as a fundamental step in patient empowerment, as it facilitates more effective communication regarding subsequent steps and treatment options. However, both patients and HCPs reported that acceptance is frequently hindered by the subjective nature of diagnostic criteria and the exclusion-based approach (quote 4). In accordance with NHG guidelines, FPs aimed to address this by providing comprehensive information about IBS, as well as gaining a clearer understanding of a patient’s health status and contributing factors such as stress and mental health. However, HCPs found this last aspect problematic, as patients may interpret psychological assessment as an indication that their symptoms are not physical in nature. The observation that patients can experience guideline-recommended psychological assessment as offensive may reflect a limited awareness among patients of national IBS guidelines and the rationale underlying them. While HCPs generally aimed to provide adequate information regarding the nature and symptomatic variability of IBS, one FP reported encountering patients who had consulted multiple colleagues repeatedly for IBS-related complaints without the possibility of an IBS diagnosis ever been explored (quote 5). This suggests that clinical expertise in recognizing and communicating IBS-related symptoms may, in the case of some HCPs, be insufficient to ensure appropriate patient education. Furthermore, many patients could not recall having received comprehensive information regarding the nature of IBS and life post-diagnosis. This perceived deficiency in personalized guidance and information provision contributed to feelings of being unsupported, resulting in patient dissatisfaction and a lack of trust in the diagnosis (quote 6).

Patient-reported outcomes - enablement, satisfaction and adherence

From the patient-reported outcome perspective, patients and HCPs recounted that uncertainty following diagnosis often leaves patients worried and suspicious. This sometimes leads patients to pursue more invasive examinations such as colonoscopy or ultrasound or to explore alternative diagnostic approaches. The latter are commonly offered by complementary medicine facilities and professionals, such as orthomolecular and bio-resonance therapists. Patients confirmed that they contribute little to the diagnostic process and mainly result in additional expense that causes frustration and confusion, negatively affecting their overall satisfaction regarding the diagnostic process.

Patient and HCP recommendations for IBS diagnosis and the use of a breath analysis device

The barriers and facilitators pictured in the metro map, and the more illustrative participant quotes emphasize the difficulty accepting an exclusion-based diagnosis. HCPs reported that patients are hesitant to accept their diagnosis when there is no evidence to prove IBS. Most participants confirmed that this experienced challenge in the diagnostic process could be addressed if a more definitive test was available (quote 7). According to both patients and HCPs, accepting a diagnosis facilitates patient-empowerment, improves the patient-HCP relationship, and is the first important step towards exploring suitable treatments (quote 8 and quote 9). Touchpoints (Supplementary Figure 2) with the breath analysis device (i.e., using it to support the clinical diagnosis) may enable direct feedback on patients’ nutrient responses or help rule out other gut-related conditions, thereby facilitating more tailored guidance on whether symptoms are nutrient-related, and informing the most appropriate next steps in clinical diagnosis. However, HCPs emphasized the importance of providing only relevant information necessary for the clinical diagnosis (e.g., yes/no sensitivity to certain nutrient) without adding details on the biomarker level, and expressed some skepticism about the ability of breath biomarkers to confirm an IBS diagnosis, as these biomarkers may be influenced by various lifestyle-related factors. Additionally, patients expressed concerns that other, more serious, diagnoses such as bowel carcinoma might be overlooked if this tool confirms that someone responds to certain nutrients (Table 2).

Table 2 The quotes related to the diagnostic process of irritable bowel syndrome.

No.	Quote	Participant
1	I noticed that when I was stressed, I had stomach pain and when I was not stressed, I still had stomach pain… But I find it hard to figure out. One time I can eat fries and feel fine because I go for a walk afterward, but another time I eat fries and then lie on the couch, and my body doesn’t handle it well. Things like that make a difference	Female patient (30 years)
2	At the end of 2017, I started having a lot of bowel problems and stomach pain again, so I went to the doctor. They did blood tests to check for a gluten allergy, but everything looked normal, so she said, ‘You have irritable bowel syndrome’	Female patient (30 years)
3	Patients often come with long-standing abdominal pain and want something done. They don’t immediately accept it when I say, ‘You meet the criteria for IBS.’ I ask, ‘What are you hoping for from me? Of course, I’ll examine your abdomen, but what did you have in mind?’ And they almost always ask for at least a blood test	Female FP (34 years)
4	I think people feel more heard when you take their symptoms seriously. But first, you need to do thorough testing, otherwise they feel like it’s just being brushed off as IBS. That’s where the challenge lies	Female FP (30 years)
5	Quite often, people mention they frequently experience a bloated stomach, or excessive bathroom usage, but there is no corresponding diagnosis recorded but I do see a long list of episodes - diarrhea, abdominal complaints, constipation - and yet the possibility of IBS has never been discussed with them. When I notice these patterns, I try to bring it up	Female FP (30 years)
6	For me, it (red: Diagnostic process) was a bit vague. I just thought I had IBS, and then the doctor said, ‘Yes, you’re familiar with the term.’ But it was never really explained to me. Then I was just referred to a website with things to try, and I thought, ‘I don’t know.’ I’ve just had poor experiences with FPs, so I’m a bit skeptical and don’t take it very seriously	Female patient (22 years)
7	I really wish there was a way to get more specific advice based on tests, like stool, blood, or breath analysis, so I would know what to try, like which probiotics or foods to avoid without having to experiment with all sorts of diets. That would be really helpful, because sometimes I still don’t know why I feel the way I do	Female patient (30 years)
8	Accepting the diagnosis - and acknowledging that it is not always as straightforward - is a fundamental prerequisite for starting the treatment process	Female FP (34 years)
9	A device like that would have been amazing. I wouldn’t have had to go through those unnecessary endoscopies, and I could have known my diagnosis with more certainty. I’m almost sure I have IBS, but I still don’t have an official diagnosis	Male patient (50 years)

IBS: Irritable bowel syndrome; FP: Family physician.

IBS management process

Health needs and expectations - understanding of health, values and preferences: Patients reported initially making dietary changes to determine whether their symptoms improve. Although some noticed a link between these dietary changes and their symptoms, they also described the trial-and-error process as cumbersome and time-consuming. According to an FP, this approach can result in unnecessarily restrictive diets (quote 10). Most patients visited their FP once they could no longer manage their symptoms independently. By consulting HCPs, they expected clearer guidance on symptom management. However, some patients indicated experiencing a lack of such guidance during this process.

Perceptions and care experience - exploring health and patient-HCP interactions: Many patients described a long and discouraging journey trying different IBS treatments. While some found partial relief through medication (e.g., peppermint oil, antidepressants) or dietary changes, most reported only temporary or no effect (quote 11). Interviews with FPs also showed that treatment strategies vary between HCPs. Where two FPs initially focus on medication-based treatment, another FP emphasizes psychological and lifestyle changes. Although many HCPs reported prioritizing shared decision-making for treatment, patients often felt that FPs made decisions about the most suitable options unilaterally. One patient, however, reported being offered ten treatment options by a nurse specialist, from which she could select one to begin with. She described this collaborative approach as positive and empowering. One well-known treatment option for IBS is the FODMAP diet. FPs and dietitians noted that it requires a strict and intensive dietary regimen. Hence, willingness to invest effort in this type of diet was often evaluated before introduction. Overall, patients reported differences in their experiences with received care. Some had positive experiences when HCPs took their thoughts and input seriously and involved them in treatment decision-making, whereas others felt unsupported after their diagnosis (quote 12). Patients who tried complementary treatments often reported that orthomolecular therapists provided long lists of nutrients to avoid while recommending various vitamins and minerals to address alleged deficiencies. Ultimately, patients became skeptical of these treatments due to a lack of symptom improvement, and the fact that most treatments were not reimbursed added to the burden. Conversely, several patients had experience with hypnotherapy and were skeptical at first but eventually experienced minor positive changes in their symptoms.

Patient-reported outcomes - enablement, satisfaction, and adherence: Patients felt unsupported due to the experienced lack of guidance. As the treatment process can be overwhelming and unpredictable, patients emphasized the importance of being heard and guided through the process by their HCPs. Although some patients learned to cope with their disease through dietary changes, the majority continued to struggle with fluctuating symptoms. Therefore, they continued to try new treatments to manage the unpredictable symptom pattern (quote 13). Some patients did experience positive effects of changes to their lifestyle after visiting the FP or dietitian, which improved their wellbeing and symptoms. Several patients who tried the FODMAP diet reported short-term symptom relief (quote 14), while others found the restrictions challenging and indicated that it caused food-related anxiety. HCPs expressed concerns about some complementary medicine treatments due to possible misinformation and negative side effects. For example, strict diets that risk causing specific nutrient deficiencies, potentially resulting in damage to the gut microbiome. One HCP, a pediatrician, offers hypnotherapy to children and confirmed that it is an effective and non-invasive method to treat IBS-related symptoms in this group, and suggested it could serve as an equally effective, non-invasive treatment option for adults (quote 15).

Patient and HCP recommendations for IBS management and use of a breath analysis device

Both patients and HCPs acknowledged that the symptom patterns and manifestations of IBS differ per person, which requires an individualized treatment regimen. However, patients indicated a need for more guidance on differences in IBS symptoms and symptom onset, along with opportunities to discuss tailored treatment options. HCPs also emphasized that a trusting relationship and effective communication are essential for IBS management, yet patients often felt that their complaints were not taken seriously (quote 16).

Furthermore, both patients and HCPs recognized that collaboration between different HCPs needs further improvement. Some dietitians reported close collaborations with physiotherapists, psychologists, and sometimes osteopaths. In addition, some FPs mentioned the possibility of a digital consultation with a gastroenterologist to avoid unnecessary referrals. Nevertheless, some HCPs, mainly dietitians, emphasized the importance of team that are more interdisciplinary to cover both physical and psychological aspects of IBS treatment. The pediatrician noted that greater openness toward hypnotherapy among adults would be desirable (quote 17).

None of the participants had experience with digital health technologies in their IBS care process. However, both patients and HCPs emphasized seeing the potential value of a tool that could support IBS treatment, particularly during the FODMAP diet, for example by promptly identifying adverse reactions to specific nutrients. As noted in the management stage of the metro map (Supplementary Figure 2), the intensive requirements of the FODMAP diet are perceived as barriers that often hinder its clinical application across the IBS patient population. Introducing a breath analysis device to potentially provide direct feedback could accelerate the trial-and-error process and improve adherence, thereby increasing the diet’s feasibility for a broader range of patients. Furthermore, HCPs underlined its potential usefulness as a motivational and educational tool in combination with a diary to obtain insights in symptom changes. Nevertheless, both patients and HCPs expressed concerns regarding overreliance on such a tool without professional guidance. Additionally, they questioned whether it would be able to account for individual variations, including stress and daily fluctuation of symptoms (quote 18; Table 3).

Table 3 Quote related to the management process of irritable bowel syndrome.

No.	Quote	Participant
10	Most people have a clear idea of what triggers their symptoms, and in some cases it’s quite extreme when they have decided on their own to eliminate gluten and lactose, which restricts their diet significantly	Female FP (34 years)
11	Well, that was basically it (red: Prescribed fiber sachets). When that didn’t work, it was more like, ‘This is what we can do, and that’s it.’ So, with my background as a dietitian, I found that a bit of an unsatisfying answer, which led me to start experimenting and researching on my own. But at that time, I didn’t get much help from my FP	Female patient and dietitian (33 years)
12	Well, I went to the doctor a few times because my intestines were often inflamed. To be honest, the doctor never really did anything specific about it. So, no, I never really received treatment, because nobody offered. I’m not even sure if there is a treatment. I was never provided with any guidance, so I’ve basically just managed it on my own since then	Female patient (24 years)
13	No, you basically have to figure it out yourself. Back then, they’d just say, ‘Well, you have this, but it’s nothing serious, figure it out on your own.’ That was 30 years ago. Now I’ve learned, for example, that eating bell peppers doesn’t sit well with me, so I try to avoid them. And if they’re in my food, I just push them to the side of my plate and pick them out	Male patient (55 years)
14	The low-FODMAP diet really did help me realize that I couldn’t tolerate certain things. But once you’re back in a more normal phase, symptoms always come back	Female patient (30 years)
15	It’s not that you’re completely put under hypnosis, but rather that you’re guided to visualize how to relax your own body. That’s the main focus, and it’s a really nice approach. But of course, everything takes time and money, and it’s not 100% effective	Pediatrician (60 years)
16	I find it hard to say what they should do differently, but I’ve been seeing doctors for years about stomach issues. They shouldn’t downplay it, and if I want a referral to a gastroenterologist, I should be able to get one	Female patient (22 years)
17	A big challenge is that people still associate hypnosis with showmen such as Rasti Rostelli, so you end up having to explain what it isn’t before explaining what it is. But overall, we’ve already made huge progress in pediatric care	Female pediatrician (60 years)
18	Sometimes I can manage to eat a little piece of apple, but I shouldn’t eat a whole apple. You know what I mean? So, I’m not sure if a distinction can be made there as well	Female patient (30 years)

FP: Family physician; FODMAP: Fermentable oligosaccharides disaccharides monosaccharides and polyols.

DISCUSSION

Main findings

This study aimed to obtain a comprehensive understanding of current IBS diagnostic and management processes, and explored if and how a breath analysis device might be integrated into the care process.

Diagnosing and managing IBS is complex due to the lack of a definitive diagnostic tool and the variability of symptoms. While HCPs aim to guide patients by providing information and discussing available treatment options, patients often experience a lack of guidance which leads to mistrust, frustration, and disappointment with their diagnosis and with HCPs. Consequently, many participants were receptive towards the idea of a breath analysis tool that could support the diagnosis and management of IBS, though some skepticism was expressed regarding its potential accuracy, and the risk of mis- and underdiagnosis of other gastrointestinal diseases was also mentioned.

Diagnosis

Despite the availability of the Rome IV criteria, the multifaceted diagnostic process of IBS remains challenging[47]. In most cases, additional examinations are still performed to rule out other chronic diseases[13]. However, an article in the Dutch Magazine for Medicine discusses the shift from exclusion-based diagnosis for IBS to a positive clinical diagnosis based on Rome IV criteria in which extensive additional examination is discouraged[12]. They emphasize that biomarkers are not needed to confirm IBS, as a clinical diagnosis provides sufficient medical certainty to confirm IBS. This appears to conflict somewhat with the opinions and needs of patients, who still try to seek a more confirmative diagnosis. Previous research also shows discrepancies between self-assessed IBS and physician-diagnosed IBS, in which self-reported IBS was three times more prevalent than IBS diagnoses using Rome IV criteria[19,20]. These discrepancies and our findings may suggest that some patients do not seek medical evaluation or do not feel that they are being taken seriously by their HCPs and thereby self-confirm their IBS. A more clinically-driven perspective is that Rome IV criteria are too restrictive and primarily capture severe IBS cases with psychological comorbidities and low QoL, which may be perceived as trivializing the experience of other patients who have significant IBS-related symptoms[20,48]. These differences between patient-experienced IBS and clinical diagnosis may help explain why patients in our study felt dismissed or insufficiently guided throughout their diagnostic process. Addressing these challenges by informing patients about the Rome criteria and the variability in symptom presentation, while acknowledging the legitimacy of their symptoms, may contribute to improved patient experiences.

Management

Providing patients with clear information on the potential benefits and risks of both conventional- and complementary treatments may reduce unstructured or random use. This process is in line with a shared decision making (SDM)-driven approach, whereby physicians and patients discuss available treatment options and collaboratively reach informed decisions[49]. Studies researching the use of SDM in inflammatory bowel disease reported improved patient care experiences, including increased trust in physicians and enhanced treatment adherence[50-52]. As one patient noted, being offered multiple treatment options by a nurse, and discussing the benefits and limitations of each, enhanced her sense of empowerment and strengthened her trust in her HCP. However, limited scientific information is available regarding adoption of SDM in IBS diagnosis and treatment. Nevertheless, researchers emphasize the importance of applying SDM in IBS treatment discussions, as patients are generally experts on their own experiences, and their engagement enables a more holistic understanding of the clinical situation[53]. For instance, in line with literature, one of the interviewed HCPs in our study indicated that discussing psychological influences can be a sensitive topic, since patients may feel that the doctor thinks ‘it’s all in their head[54]. However, literature and guidelines emphasize the importance of addressing psychological factors that can influence patients’ IBS symptoms, such as stress and anxiety[10-12,15]. Additionally, a meta-analysis confirmed that psychotherapeutic approaches such as cognitive behavioral therapy and gut-directed hypnotherapy - which target the gut–brain axis through relaxation techniques combined with guided imagery and sensory suggestions - are effective in reducing symptoms[55]. By adopting SDM, and first providing clear information about the gut–brain axis and the potential benefits of psychologically-focused treatments, HCPs may improve patients’ understanding of these approaches. This may help patients better accept recommendations for psychological care, such as referrals to a psychologist or hypnotherapist, and in turn strengthen trust in their HCPs. The breath analysis tool could support SDM by providing patients and HCPs with objective insights into data, complementing subjective data. However, careful interpretation of such data remains essential in the clinical decision-making process to prevent decisions from being solely made on objective measurements without sufficiently considering patient experiences[56].

Digital health innovations in IBS care

Participants in this study reported no personal experience with digital health innovations in IBS care. However, research on these technologies is rapidly increasing[33]. Despite clinical shifts toward a positive diagnosis approach for IBS rather than one based on exclusion[12,38], the lack of a definitive confirmatory test remains a significant challenge for both patients and HCPs. Patients, especially, require greater diagnostic certainty to foster trust in the diagnosis. Digital technologies can support a more precise diagnosis by non-invasively assessing the gut environment, collecting content from the small or large intestine, and measuring pH, temperature, and gas production[57]. Machine learning algorithms enable these tools to analyze large sets of data on microbiota profiles and stool biomarkers[31]. The breath analysis tool, which is still in the early development phase (i.e., technical readiness level 3-4), is based on the analysis of biomarkers in a patient’s breath[34]. According to literature, breath biomarkers can distinguish individuals with IBS from those without, with reported sensitivities of up to 89.4%[34,58,59]. However, none of these methods have been implemented in practice and there is still a lack of studies showing the potential use of breath biomarkers in managing IBS, which poses the dual challenges of accuracy and successful implementation. Participants in this qualitative study indicated that a breath analysis tool could potentially be valuable for future diagnostic and management processes, as it might be less invasive and more definitive. This would help overcome uncertainties in diagnosis confirmation and management, thereby empowering patients and improving patient-HCP relationships. However, there was also skepticism concerning accuracy and practical implementation in routine care, including whether it could achieve its intended purpose without overlooking other, more severe, bowel conditions. Hence, it is important to ensure that tools are validated using both internal and external datasets and implemented gradually, with sufficient training for both patients and HCPs, to avoid overreliance on data and to reduce potential anxiety due to abnormal measurements[60]. Another issue is that existing literature highlights the importance of psychological factors in the diagnosis and management of IBS[26-28], suggesting that practice should combine both measurable physiological variables and patient-experienced psychological factors. This highlights the importance of continuing the co-creation process throughout the development of the breath analysis device in order to ensure it accords with research findings, end user needs, and existing care processes.

Strengths and limitations

To our knowledge, few studies to date have extensively explored both patient and HCP perspectives on IBS care. We also examined both diagnosis and management processes, as well as considering views on the potential use of a breath analysis device. Early involvement of prospective end users throughout the development of this device will allow anticipation of the IBS care process and end user needs during further development[61]. Additionally, this co-creation study followed the first stage of the well-accepted CeHRes roadmap, enhancing reproducibility in other settings, including different countries, diseases, or innovations.

All participants in this study were highly educated and Dutch-speaking, meaning that the findings likely skew towards people with higher than average digital and literacy skills. Previous research suggests that digital innovations reinforce inequality within vulnerable populations[62]. The absence of perspectives from individuals with low health literacy may have resulted in a biased assessment of the tool’s clinical relevance and usability in broader IBS care. Consequently, this could negatively affect the already existing inequalities in the adoption of health technologies and healthcare in general[63]. Conversely, a more objective diagnostic test might be particularly beneficial for individuals with limited health literacy, providing the tangible validation that a positive clinical diagnosis may lack. Future studies should therefore aim to involve individuals with diverse levels of (digital) health and educational literacy to ensure that such innovations are accessible and applicable to the entire IBS population[60].

CONCLUSION

This study provided a comprehensive picture of a patient’s IBS care journey from diagnosis to management in the Netherlands, including both patient and HCP perspectives. Consistent with existing literature, both diagnosis and management remain complex and often challenging. Although guidelines and practice have shifted towards a positive clinical diagnosis, patients, and in some cases also HCPs, appear to keenly anticipate a more definitive test confirming IBS. This raises the question of whether a more definitive diagnostic test and supporting management tool would enhance patient empowerment and improve the patient-HCP relationship. Future research should focus on finding a distinctive set of biomarkers for the diagnosis and management of IBS, complemented by other relevant health metrics such as activity and stress. More importantly, studies should focus on the successful implementation of such innovations by continuously engaging with prospective end users such as patients and the wide variety of HCPs involved in IBS care, such as FPs, dietitians, and mental health professionals. A more interdisciplinary approach could be adopted when introducing digital health innovations, enabling different stakeholders to be directly involved in the diagnosis and management of patients with IBS. This can ultimately enhance user-friendliness, trust amongst patient and HCP users, and successful integration within different HCP workflows, providing more personalized care through a more interdisciplinary and holistic approach. This hybrid care process will facilitate a more personalized approach to the diagnosis and management of IBS, enhancing patient experiences, clinical outcomes, and patient-physician relationships.

ACKNOWLEDGEMENTS

We want to thank all the participants both patients an HCPs for taking the time for an interview and providing us with insights about their experiences and ideas concerning IBS.