Two United Kingdom hospitals were used to recruit participants from an outpatient clinic list. Potentially eligible patients were given written information about the project from a clinician. Verbal consent to be contacted was obtained by a clinician. Participant contact details were provided to the research team. Contact was then made by email/telephone by a researcher who confirmed eligibility, provided more information about the project and obtained further verbal or written consent from participants for their participation. An interview was arranged to take place online using Microsoft Teams, or Zoom depending on participant preference. Further verbal consent was obtained prior to each interview.

Social media was used to disseminate an advertisement about the project and invite those who were eligible to complete an online questionnaire. The research team shared the survey with relevant charity organisations to disseminate with their subscribers and followers. Participants completed an online consent form prior to completing the survey.

How many participants are required for qualitative research remains equivocal [17]. Qualitative samples must be large enough so that all of the perceptions that might be important about experiences of living with and managing parastomal bulging are uncovered, but not too large so that data becomes repetitive and, eventually, superfluous. We aimed to use purposive sampling to recruit 20 participants with different types of stoma (ileostomy, colostomy), diagnoses (colorectal cancer, IBD) gender and age. The method of ‘data saturation’ [18] was used to determine the final sample size, which led to the final number of participants (n = 17) being slightly lower than our original target of 20 participants.

A convenience sample was used to recruit participants. The survey was designed to gather descriptive data about experiences of parastomal bulging. It was not statistically powered.

A semi-structured interview schedule with open-ended questions was developed by two members of the research team (JM, GH) and the Patient Advisory Group and included the following topics for discussion: 1) diagnosis of parastomal hernia, 2) experiences of parastomal bulging progression, e.g., Did bulging change over time?, 3) medical treatment and decision-making e.g., experience of help-seeking for parastomal bulging, 4) self-management e.g., use of support garments, 5) impact on QoL, e.g., impact on daily activities. JM conducted the online interviews; a female researcher with experience in qualitative methods and interviewing this patient population. There was no prior relationship between the interviewer and participants. Online qualitative interviewing methods are increasingly popular and work well using a structured interview approach [19]. Interviews lasted approximately 43 min. With participant’s permission, the interview was audio-recorded.

Two validated questionnaires relevant to investigating themes identified from analysis of interview data were used. The Patient Activation Measure is a validated questionnaire designed to measure the knowledge, skills and confidence that a person has to manage their own wellbeing (patient activation) [20]. Self-efficacy, which measures one’s expectations regarding the ability to perform some specific task was assessed using the 28-item stoma-related self-efficacy scale [21]. Other survey questions were about self-management for parastomal bulging with nine response options (e.g., support garments, staying active) and perceptions of these self-management approaches working with a yes/no response. Participants were also asked to rank in order importance five types of support for managing parastomal bulging (e.g., access to stoma nurse, support garments).

The data from the audio-recorded interviews were anonymised by giving participants a study code, and by removing any reference of places, names, or NHS Trusts from the transcription before analysis. The Framework method, adopting thematic analysis, which is a rigorous method providing a structure within which qualitative data are organised and coded thematically, was used to analyse data by a member of the research team (JM, WG) [22]. Transcripts were read to gain an overall sense of the themes that were emerging from the data. Common words, phrases and sentences that conveyed a theme, or feeling, or experience were identified. The data were coded and categorised while new data was added through the iterative process and looking for a level of data saturation to ensure important issues were not missed. The comparison process was ongoing while new interviews were held and analysed to look for new emerging themes. The process provides a level of coding for the data produced which allows for themes to evolve around the data being collected rather than focusing on a fixed question.

All responses were summed and reported descriptively. For the Patient Activation Measure, raw data was entered into the scoring algorithm to produce a PAM score along an interval-level scale from 0–100 that corresponds to one of four levels. The four levels of the measure demonstrate levels of activation to engage in active self-management: Level 1—Disengaged and overwhelmed, 2—Becoming aware but still struggling, 3 –Taking action, Level 4—Maintaining behaviour and pushing forward. For the stoma self-efficacy scale, the score range was 28–140; the scale contains the Care Self-efficacy, and social self-efficacy all scored on a 5 point scale. <65 indicates low self-efficacy; 66–102 moderate self-efficacy; >103 high self-efficacy.

For those reporting gradual onset, parastomal bulging seemed to have been apparent since stoma formation surgery, with slow worsening (e.g., pain, enlarging) over a period of months/years. For the few who experienced sudden onset of bulging, there was a particular moment or short time period in which bulging appeared. This was often due to coughing or sneezing. One participant reported that bulging had appeared on an old stoma site and then on newly sited stoma positions resulting in two parastomal bulges. The physical restrictions of having a large bulge were shared and included not being able to bend over properly to tie laced shoes, and on general mobility. When prompted about the effect of parastomal bulging on the function of their stoma, participants referred to bag adhesion issues and resulting leaks, being more prone to blockages due to change in shape, and also issues with emptying due to the shape of their bulge.

Some participants felt well informed about their risk of parastomal bulging, whereas others remarked that they had never been advised that bulging might develop. Consistently, even for those who felt they were fairly well informed there was an expressed need for more information. Living with a stoma and parastomal bulging is a long-term condition requiring regular self-management and support from healthcare professionals. Throughout the interviews it was clear that there were variations in the level of care and support being provided from healthcare professionals. Some participants reporting excellent follow up care following surgery and direct access to their stoma care nurse, while others felt they had been left with little to no follow up care to manage their stoma and parastomal bulging. Commonly patients reported the delay in being measured for, and receiving abdominal support garments. The COVID-19 pandemic was often given as a reason for delays by healthcare professionals, and by patients. The complexity of stoma care and industry and supplies companies, and the employment of stoma nurses were openly discussed with a high level of awareness and understanding of this within this sample of patients. This came with some confusion about who to contact in the first instance for support: a surgeon, stoma care team in the hospital, community stoma nurse, GP, supplies companies, etc. One patient shared that he often heard the term ‘lost ostomate’ for people who had been lost to follow up in the complexities of the system. But consistently the importance of having clinical support from a stoma nurse, and knowing how and when to access that support was a priority.

When discussing treatments for parastomal bulging all participants were aware of surgery as a possible intervention. Discussions focused mainly on failed repairs, and surgeons not offering or refusing repair surgery due to the nature of the bulge and the high recurrence rate. Many reported that they did not want any more surgery, particularly in relation to the risk of recurrence and issues with more abdominal surgery and the recovery involved. No participants explicitly mentioned options they had been presented with that did not include surgery for their parastomal bulging self-management, with the exception of support garments. So, despite surgeons being open about risks and failure rates of repair surgery, participants were not provided with non-surgical alternatives at the time of these discussions within their healthcare team. Reasons by participants for not accepting surgical repair included bulging not affecting stoma function, previous failed repairs, anxiety over further surgery, bulge being too small, and original surgery already siting a mesh reinforcement at the stoma site.

Support garments were the main and often only self-management behaviour that participants used. Positive experiences included physical support, comfort and a feeling of control. Negative experiences with support garments included issues around delays in measurement and delivery after surgery; wrong sizing causing issues with bag functions or emptying; discomfort, leaks, pain, slipping down, poor bag emptying. Yet, even when participants attributed their support garment to negative experiences they still continued to wear the garment to support the bulge. A couple of participants indicated that they wear two support garments at one time for additional support. There was some confusion about when a garment should be worn, such as when physically active, lifting weights, carrying shopping, when lying down, or sleeping at night. A support garment was worn as a precaution. A recurring topic from almost all participants was the delay in support garment provision after surgery, the negative effect of the wait involved, and the lack of physical support for the stoma area post-surgery.

Participants were asked what they felt was missing from their own supportive care, and what a potential intervention on parastomal bulging self-management might include for their personal needs. The ‘need for information’ was the overwhelming feedback, with no specific mode of delivery taking preference in terms of online, app, hard copies, videos, etc.,—all were deemed suitable. Information topics were wide ranging and included: support garment fitting; ranges of appliances available that might be better for herniated stomas, safe exercises pre-and post-surgery, weight management advice, and mental health support. There was brief mention of some supportive care pre-surgery, but there was no awareness that there may be many benefits to this type of approach. There was an understanding that being physically active was beneficial but there was confusion about what exercises would be beneficial or how being active would help in terms of parastomal bulging self-management.

Some participants welcomed peer support but there was no consistent feedback on how this might be delivered with mention of local support groups, online social media groups and charity input. Perceived benefits of peer support included mental health, ‘tips’ on managing daily challenges of ‘thickening output’, ‘bags that fit around the bigger lumps’, and managing and tidying up after recurrent leaks.

Sixty percent of survey participants scored in the activated phases for self-management of parastomal bulging on the patient activation measure (PAM) (Table 3).

The mean total self-efficacy score was 97 (min 42:max 137; standard deviation 25). Eighty-eight percent of participants scored medium (n = 25, 43%) to high (n = 26, 45%) self-efficacy for stoma care; twelve percent (n = 7) scored low self-efficacy.

Support garments and staying active were the most commonly used self-management choices (Figure 1).

Fifty-seven percent of participants ranked support garments as the most important type of support for managing parastomal bulging. This was followed by improved access to a stoma nurse and exercise advice (41% and 40% respectively) as shown in Figure 2.