Development of a complex nursing intervention for the management of patients with a stoma complicated by a parastomal bulge

Abstract

Background

The focus on late complications after colorectal surgery has increased in the last decade, including the difficulty of surgical and non-surgical management of parastomal bulging. Parastomal bulging is the most significant complication of a stoma, affecting half of ostomy patients in the long term and negatively impacting on quality of life. Stoma care nurses mainly manage a parastomal bulge, although most stoma care nurses find treatment complex and symptoms related to the bulge difficult to handle. Evidence-based guidelines and a structured approach to the many symptoms patients present are limited. Thus, this paper aimed to describe the development of a complex nursing intervention program for the management of parastomal bulges.

Methods

The study was based on the Medical Research Council (MRC) framework for Complex Interventions. To strengthen the clinical applicability and relevance of the program, Bleijenberg’s approach was integrated into the MRC framework. The program development followed three phases outlined by the MRC framework: 1) identifying the evidence base, 2) developing theory and 3) modelling process and outcomes. The intervention was designed for stoma care nurses working in hospital ostomy clinics.

Results

The intervention was developed through an iterative process over 12 months and comprised a Scoping review, workshops and a Consensus Conference. Feedback from clinical experts was integrated throughout the development process. The program, named Parastomal Bulging Intervention (PBI) – a nurse-led intervention for identifying, assessing and managing symptoms in patients with parastomal bulge, consisted of three components: A) Systematic approach to the nursing consultation, B) Symptom-specific nursing treatment algorithms and C) Supplemental information and guidance.

Conclusion

The MRC framework was successfully applied to develop a program for complex nursing interventions for patients with a parastomal bulge. By incorporating elements from Bleijenberg during the development phase, we ensured that the needs of recipients and providers were addressed, thereby enhancing the program’s suitability for clinical practice. The feasibility and acceptability of the PBI will be tested in future studies.

Clinical trail number

Not applicable.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12912-025-03760-z.

Introduction

Having a stoma is a well-known condition with more than 1,500,000 cases among Europeans and Americans [1, 2] created as part of the surgical treatment of either malignant or benign diseases such as bowel cancer, inflammatory bowel disease and faecal incontinence. Parastomal bulging is the most significant complication of a stoma, affecting half of ostomy patients long-term [3] and likely also patients’ quality of life [4, 5] As opposed to ‘parastomal hernia, the term ‘parastomal bulging’ comprises both subcutaneous prolapse, true parastomal hernia and a few with pseudo-hernia [6], which makes sense since clinical symptoms and patient outcomes are likely the same [7, 8]. Further, differentiation can be challenging at clinical examination, which is the main method used in clinical practice for diagnosis [9], typically performed by stoma care nurses (SCNs).

Although surgical techniques have evolved, the morbidity of stomas remains high [10, 11]. The focus on late complications after colorectal surgery has increased in the last decade, including the difficulty of surgical and non-surgical management of parastomal bulging. A parastomal bulge is mainly managed by SCNs [12, 13], although most find symptoms related to the bulge difficult to handle [13]. We found only a few national guidelines to support SCNs in their management of parastomal bulging [14–17]. The lack of evidence on nursing interventions likely contributes to the difficult management of parastomal bulging [13, 14, 18]. Furthermore, we could not find comprehensive guidance on the content of nursing consultations, specifically concerning a structured approach to address the diverse symptoms that patients present. From a clinical perspective, a structured approach may support and strengthen SCNs in the management of symptoms related to a parastomal bulge.

The importance of evidence-based nursing has been recognised for decades due to its positive effect on the quality of care and improved patient outcomes, including reduced mortality, shorter length of stay, and fewer readmissions and complications [19]. Evidence-based practice ensures more effective nursing care with better clinical judgement while having a patient-centred approach [20]. However, nurses need guidance [21] to obtain the necessary structure in practice [12, 21–23], which an evidence-based approach requires. Chronic and complex patients, such as those with ostomy and parastomal bulges, must be treated by skilled nurses with appropriate clinical experience to enable positive patient outcomes [24]. There is a need to develop an intervention targeted at SCNs and tailored to support the needs of patients with a parastomal bulge concerning symptom management. To enhance transparency and usability and contribute to the new era of intervention studies [25], the development of a program theory should be reported in detail. Thus, this paper aims to describe the development of a complex nursing intervention for the management of parastomal bulges.

Overall methods

We applied the updated Medical Research Council (MRC) framework for Complex Interventions to guide us through the development process of the intervention [26]. The framework supports the research by structuring the process into four stages: development, feasibility, evaluation and implementation [26–28]. This article will report on the development phase. According to the MRC Framework, a complex intervention is developed in a systematic approach consisting of three stages: 1) identifying the evidence base, 2) identifying or developing theory and 3) modelling process and outcomes.

To strengthen the development phase and the fit to clinical practice, we used the approach suggested by Bleijenberg et al. (2018), adding another three elements to the MRC Framework: problem definition, determination of recipients/providers’ needs, and examining practice & context [29]. ‘Intervention design’, describing elements such as the amount of time and duration of the intervention, will not be reported here, although suggested by Blejenberg et al. (2018). We expect to generate data on such outcomes in a future feasibility study testing the intervention.

The target population

To ensure the acceptability of the intervention among stoma care nurses (SCNs) (target group) in clinical practice, a target-population-centred approach was chosen [30]. The present intervention targets SCNs in hospital ostomy clinics to support them in treating patients with a parastomal bulge uniformly and evidence-based, to help patients live with the parastomal bulge. Such complex interventions require the competencies of a specialist nurse and hold the potential of improving outcomes in patients with complex and chronic conditions, such as quality of life, health behaviour, medication adherence, and patient satisfaction [24]. Hence, consultations with complex patients should be held by well-educated nurses with appropriate clinical experience [24].

Setting

The intervention was developed at the outpatient stoma clinic at Zealand University Hospital, Koege, Denmark. Annually, the clinic conducts approximately 2500 in-person and telephone consultations, with 250–300 patients leaving the hospital each year with a newly formed stoma.

In Denmark, patients with a stoma, including those with a parastomal bulge, are followed by SCNs at scheduled follow-ups within one year of surgery. Hereafter, needs-based follow-up is possible, aligning well with international standards [18] and free of charge. Outpatient clinics are usually open on weekdays during the daytime and are staffed by nurses, some of whom are educated as stoma care specialists (enterostomal therapists). Hospital clinics generally have a large storage of products such as stoma appliances, support garments and other stoma care products.

To ensure the potential for replication in research and usability in clinical practice [31, 32], we adhered to the Template for Intervention Description (TIDieR) throughout the manuscript, providing detailed and qualified reporting of the intervention development. Additionally, to support transparent reporting of the process, we followed the “Guidance for reporting intervention development studies in health research” (GUIDED) [33], Additional file 1.

Developing a complex intervention

Overview of the intervention development process

Using the MRC framework as a structure for the development, we integrated the additional elements suggested by Blejenberg, as depicted in Fig. 1.

Fig. 1.

The four phases of developing the parastomal bulging intervention (PBI). Illustration of the three stages (1–3) of the MRC framework, leading to the final intervention (4). In stage 1, Blejenberg’s elements, ‘problem definition’ (a) and needs assessment &examining practice (b), were integrated into the development process to ensure alignment with clinical practice

The data collection methods used in the development process comprised three methodological approaches: Scoping review by Joanna Briggs Institute [34] (Fig. 1c), Workshops by Future Framework [35] (Fig. 1b) and Consensus Conference [36] defined as a structured method for gathering and synthesizing expert opinions on complex issues [36] (Fig. 1a). The intervention was developed in an iterative process over 12 months. Feedback from clinical experts was incorporated into the development (Fig. 1b). In the following, we present the overall stages in the MRC Framework along with each stage’s methods and respective main findings. Details on the three data collection methods, participants and findings are provided in Additional files 2 and 3 or the published article [37].

MRC stage 1: Identifying the evidence base

Determination of the problem and needs of patients and providers from their perception is key in the development of a complex intervention [28, 29]. Reviewing the existing evidence is likewise essential to inform all steps of the development process [28]. From previous qualitative individual and focus group studies, we gained an in-depth understanding of patients’ perspectives on living with a parastomal bulge and their perceptions of information and guidance from healthcare professionals [22, 23, 38]. Quantitative studies have provided insights into patients’ symptoms, symptom load and the impact of a parastomal bulge on health-related quality of life [5, 22]. To gain insights into nursing management options, we conducted a Scoping review of the literature [37]. To further assess the problems and needs of patients and providers, workshops with expert participation were conducted.

Literature review

To quantify any relevant nursing intervention for the management of parastomal bulges [37], we reviewed the literature systematically [37]. From 44 included studies, 8 nursing interventions were suggested however on a limited evidence-base providing almost no evidence on the effectiveness of interventions: (1) Appliance, (2) Support garment, (3) Irrigation and regulation of stool, (4) How to access signs and symptoms of strangulation, (5) Disguise and intimacy, (6) Physical activity, (7) Support and Education, (8) Record keeping, follow-up and referral. The study also highlighted how one nursing intervention can be employed to manage multiple symptoms and potentially several symptoms simultaneously. Notably, several interventions may be needed to address a single symptom [37]. The scoping review identified eight main symptoms related to a parastomal bulge: Leakage, skin problems, irregular stool and gas, bearing down sensation, physical impairment, pain, changed body image and intimacy problems, psychological impairment and social isolation. These findings formed the foundation for the program theory and the development of an algorithm for specialised nursing interventions targeting specific symptoms. To ensure the practical applicability of these interventions, a symptom-specific nursing intervention algorithm was created for each of the eight symptoms, outlining the relevant nursing interventions in a recommended sequence.

Problem, needs and practice assessment

In spring 2024, a total of 19 experts participated in three workshops aiming to obtain knowledge of symptom management options for patients with a parastomal bulge and gain insights into their experiences and views on clinical practice treatment of parastomal bulging. Table 1 depicts participants in the workshops. For more information, see Additional file 1.

Table 1.

Participants in the three workshops

	Stoma Care Nurse, n	Surgeon, n	Garment manufacturer, n	Patient with parastomal bulge, n	Close relative, n	Total, n
Workshop 1	3	-	-	2	1	6
Workshop 2	2	-	1	4	-	7
Workshop 3	2	1	-	3	-	6

Findings: SCNs described that they felt frustrated and alone due to a lack of knowledge and guidance on how to manage symptoms and problems related to the parastomal bulge. They wished for a national evidence-based guideline to ensure consistency across stoma clinics and primary care centres and to have uniform information materials for patients. Most described how they used a holistic and person-centred approach and aligned expectations for outcomes of the treatment with the patient. Manufacturers emphasised the need for uniform services across municipalities, while surgeons highlighted the importance of consistent information and access to surgical treatment. Workshop participants contributed various elements to the intervention, including the need for specific information on training activities, suggestions for addressing social isolation and physical activity limitations, and the benefits of lying down to facilitate regular bowel movements (Additional file 2). Further, patients and relatives stated that healthcare professionals provided conflicting information about the bulge and the management of symptoms. They wished for better continuity in their information and treatment, as well as more comprehensive information overall. Most patients wanted to be involved in the treatment and to discuss possible management options with the SCN. Some preferred regular follow-ups by their SCN, while others just wished for easy access to an SCN when problems arose. All pointed to the importance of easy and swift access to help from an SCN when an acute problem arose [35]. The findings pointed to three key elements of importance for the complex intervention: a structure for nursing consultations, a personalised approach to patient problems and information practices.

MRC stage 2: Identifying theory

Multiple theories may determine the mechanism by which the intervention and its mechanism are supposed to work [29]. For the present study, SNCs consult with patients autonomously and thus need advanced consultation skills for the successful treatment of patients. In treating patients with a parastomal bulge, a systematic approach is needed to ensure the appropriate application of nursing interventions by providing structure and ensuring the involvement of patient perspectives of their experiences [39].

Theoretical framework

We identified four different theoretical frameworks on nursing consultations, Consultation Assessment and Improvement Instrument for Nurses (CAIIN) [40]. The good Consultation, guide for Nurses, the Disease-illness model, Pendleton’s consultation model and the Cambridge-Calgary model [39]. They all provide a structure for conducting a clinical consultation in advanced practice. We chose CAIIN [40] which consists of seven elements, (1) Interviewing, (2) Examination, diagnostic testing and practical procedures, (3) Care planning and patient management, (4) Problem solving, (5) Behaviour and relationship with patients, (6) Health promotion/disease prevention and (7) Record keeping. It is recommended to use the first three elements in the suggested order to structure the consultation, while the (4) ‘Problem-solving’ may be challenged continuously within the consultation. We found this approach relevant to consultations provided by SCNs having an individualised and person-centred approach in meeting with complex patients [21–23, 41]. Further, we deemed a structure for the consultation important to support the usefulness and later implementation of a complex intervention for parastomal bulging. Moreover, the approach aligns well with the requirement of SCNs to facilitate a confidential and safe environment to ensure person-centred consultation [15, 21, 41]; discuss treatment options to empower the patient to oversee stoma management [15, 21]; and have a holistic perspective and respect for the patient’s opinion and wishes [41] Finally, SCNs should offer regular follow-up [14–16, 18] as well as the possibility for further follow-up if the patient needs it [18, 22].

MRC stage 3: Modelling process and outcomes

Modelling the prototype of a complex intervention and describing the pathways within the intervention can help clarify how it may lead to long-term outcomes. It also increases the understanding of the mechanisms and different components of the intervention [28, 29].

We divided the modelling process into three substages: 1) Consensus Conference, 2) Stakeholder feedback, and 3) Modelling the intervention by use of logic modelling. Although depicted linearly, the process of modelling was non-linear.

Consensus conference

A Consensus Conference consisting of four sessions was held during a National Stoma Care Conference in the autumn of 2024. At the conference, we aimed to obtain an expert evaluation of the prototype of the PBI, specifically the intervention algorithm that had been created for each of the eight symptoms, outlining the relevant nursing interventions for each of them. The evaluation also focused on the practical applicability and usability of the interventions. A total of 69 nurses and SCNs participated. Participant characteristics are found in Table 2, while more information on the method and findings is described in Additional file 3.

Table 2.

Demographic data of the 69 participants (n (%)) from the consensus conference

Total years of experience with stoma care
Less than 1 year	5 (7)
1–5 years	15 (22)
6–10 years	20 (29)
11–20 years	18 (26)
21–25 years	8 (12)
More than 25 years	3 (4)
Education apart from registered nurse
Enterostoma therapist	9 (13)
Diploma in Stoma Care	4 (6)
Other education	5 (7)
No	51 (74)
Workplace
Ostomy Clinic	18 (27)
Hospital ward	9 (13)
Hospital ward and Ostomy Clinic	15 (22)
Primary Care	26 (38)
Missing, n = 1
Region
Region Zealand	12 (18)
The Region of Southern Denmark	24 (36)
The North Denmark Region	9 (13)
The Capital Region	14 (21)
Central Denmark Region	7 (10)
Faroe Islands	1 (2)
Missing, n = 2

Findings: Overall, the participants pointed to the need for dividing nursing management strategies into general principles of nursing treatment that should always be considered before proceeding to the specialised nursing interventions. The general principles encompassed, e.g., patients’ appliance technique, how to measure stoma size and how changing the appliance should not be done with the patient lying down. Further, they pointed to the need for an algorithm for the order in which the interventions should be applied. Feedback also led to the inclusion of valid tools, e.g., Visual Analogue Scale for pain measurement [42] and the Bristol Stool Form Scale [43], that had not been addressed in the literature review. No specific tool for assessing peristomal skin changes was suggested. Suggestions also led to modifications of wording throughout the program. SCNs experiences, tips and tricks with clothing and support wear were likewise added to the program.

Stakeholder feedback

In a local workshop, SCNs provided feedback and clinical input to the Consensus Conference results. Specifically, how to separate general and specialised nursing interventions and the sequence and possible outcomes from the general basic interventions were addressed. In the workshop, it was likewise deemed unnecessary to guide SCNs’ consultations concerning the professional relationship with patients (‘Behaviour and relationship with patients’) [40] while ‘Health promotion/disease prevention’ was incorporated in the intervention algorithms. Further, the SCNs provided feedback and clinical input to the development of intervention algorithms. This was regarded as highly relevant for the applicability of the intervention and the later outputs since the order of interventions was sparsely documented in the literature [37]. In this way, the SCNs were both a valuable resource to the research team and helped pave the way for the future acceptance of the intervention among colleagues.

Logic modelling

A logic model for the intervention can be useful for conveying information about how an intervention works and how the theory and assumptions underlie the intervention. In five core elements, the logic model links the intervention activities with the short and long-term outcomes by covering Resources/Inputs, Activities, Mechanisms, Outcomes and Impact [28, 29]. ‘Resources’ specifies material resources needed to enable the delivery of the intervention, ‘Activities’ describes the active ingredients, while ‘Mechanism’ explains how the active ingredients are expected to produce the desired changes [28]. The ‘Outcomes’ cover the intermediate and the expected long-term outcomes of the intervention. Authors MK, CL, TBB, MUP, and PD all contributed to the final modelling of the intervention (Fig. 2).

Fig. 2.

The basic logic model of the intervention. Illustration of the five core elements of the intervention, showing how activities are linked to short-term and long-term outcomes. The primary goal is to reduce the impact of symptoms on patients’ daily lives and to help patients feel reassured that all relevant actions have been taken

Final intervention

The final intervention is a multi-component nursing management bundle named the PBI (Parastomal Bulging Intervention – a nurse-led intervention for identifying, assessing and managing symptoms in patients with parastomal bulge). The PBI consists of three components: A) Systematic approach to the nursing consultation, B) Symptom-specific nursing intervention algorithms and C) Supplemental information and guidance.

A) Systematic approach to the nursing consultation

The strategy for the nursing consultation comprises: (1) Principles for uncovering symptoms and problems, (2) Clinical examination and appraisal, (3) Formulating a treatment plan in collaboration with the patient, (4) Documentation & Information and (5) Evaluation and Follow-up.

1. The principles for uncovering symptoms and problems include taking a clinical history of the changes brought on by the bulge, uncovering the impact on the patient’s everyday life and the patient pointing out the most important problem(s).

2. The Clinical examination and appraisal are considered relevant to all patients with a parastomal bulge and comprise a systematic and guided assessment of the appliance technique, the skin, stoma, bulge, stool and patient compliance in stoma care.

3. Based on the results from the first two principles, the SCN will formulate a treatment plan in collaboration with the patient. The general principles for appliance technique should always be considered as a first step to a patient’s symptoms. If the general principles are not considered likely to resolve the patient’s symptoms, the SCN should proceed to the symptom-specific Nursing intervention algorithms (B).

4. Documentation and information comprise appropriate and legible record keeping summarising key findings, including the changes brought on by the bulge, symptoms, the most important symptoms according to the patient, and the results from the clinical examination. Photo documentation is encouraged. A care plan should be provided to the patient, and for primary care, if they are involved in stoma care, including the date for follow-up. The patient should be educated, informed and provided written information about the nature of the bulge, serious symptoms, and treatment options, including referral to a surgeon.

5. Evaluation and follow-up comprising a decision on how and when to follow up and providing the patient with the possibility to contact the clinic if in need.

B) Symptom-specific nursing intervention algorithms

The symptom-specific nursing intervention algorithms consist of eight categories of symptoms and related nursing interventions. The eight symptoms are: leakage, skin problems, irregular stool and gas, bearing down sensation, physical impairment, pain, changed body image and intimacy problems, psychological impairment and social isolation. Firstly, based on the patient’s most important symptom(s), the SCN should choose the relevant symptom-specific nursing intervention in the algorithm. When applying the nursing interventions, they should be applied in the recommended sequence. For each symptom, 3–5 different nursing interventions are described in a sequence, as shown in Fig. 3. For example, for a patient experiencing ‘Leakage’, the SCN will begin with the intervention ‘Appliance’, then move to ‘Support Garment’, and proceed to ‘Regulation and Irrigation of stool’ until the issue is resolved. Detailed descriptions and instructions for each of the nursing interventions (e.g. Appliance, Support Garment, ‘Regulation and Irrigation of stool’) are provided in a booklet, which presents up to 10 detailed management interventions in an easy-to-follow format. This manuscript does not include the booklet containing these highly detailed descriptions of each nursing management intervention. Although easy to follow, the booklet is comprehensive and specifically targeted to the Danish context and written in Danish. However, the booklet will provide essential guidance to stoma care nurses in clinical practice and ensure the clinical applicability of the nursing interventions in the PBI.

Fig. 3.

The symptom-specific nursing intervention algorithm. The sequence of nursing interventions for each of the eight symptoms addressed in the PBI, based on the patient’s most important symptom(s). Each intervention is supported by a detailed instruction booklet for nurses (not included in the article)

C) Supplemental information and guidance

The supplemental information and booklet will offer SCNs extended descriptions and photos of clinical examination methods, instructions on measuring the bulge and stoma, stoma-specific physical activity exercises, and dietary recommendations. Furthermore, an extended description of how to conduct nursing consultations with a complex patient will be provided. Supplemental information will also comprise a patient information sheet on parastomal bulging, as well as drawings and text illustrating and defining parastomal bulging. Lastly, a description and photos of various types of support garments will be included. The content in the supplemental material was included in the PBI to ensure uniformity and to enable SCNs, regardless of experience and knowledge, to use the intervention in clinical practice.

Discussion of strengths and weaknesses

This study aimed to describe the development process of a complex intervention targeted to SCNs guiding the identification, assessment and management of symptoms in patients with a parastomal bulge. Using the MRC framework combined with the elements suggested by Blejenberg [28, 29] was a feasible and step-by-step approach that systematically provided structure and guidance and helped us design an intervention with multiple components that we believe apply to clinical practice.

Based on the complexity of treating patients with a parastomal bulge, it was decided to limit the setting to in-hospital ostomy clinics; hence, ostomy care in a primary care setting was not targeted. The decision was based on two considerations. First, the various intervention options require a large supply of stoma products and support garments, which are not available in a primary care setting. Second, treating patients with complex and chronic conditions using a complex intervention such as the PBI requires well-educated nurses with specialised clinical experience [24]. Due to the diverse tasks and treatment areas primary care nurses must cover, many are likely to be less experienced and knowledgeable in caring for individuals with a stoma complicated by a parastomal bulge. However, to accommodate highly relevant viewpoints from the workshops, the PBI provides guidance on detailed care plans from the hospital clinic to primary care.

Determination and understanding of the needs of the recipients and the providers are fundamental elements that should be incorporated into any development process [29]. In the current project, we utilised insights from previous and extensive research within the field conducted by international researchers and our research group. Through the workshops, we gained additional knowledge of both providers’ and recipients’ needs, particularly on the content of nursing consultations. During the Consensus Conference, we gained insights into SCNs specific needs regarding the content of the general and symptom-specific intervention algorithms. We believe the results were strengthened by the fact that four in 10 SCNs had more than 10 years of experience in stoma care. The Consensus Conference was structured around group work, which poses the risk of some members being silenced or not having their voices heard. Acknowledging this risk, we emphasised the importance of mutual viewpoints when introducing the group work. Initially, we considered conducting a modified Delphi study. However, Delphi studies may be susceptible to declining response rates over successive rounds. Furthermore, we were unsure about the reliability and applicability of the results of this approach since the nursing practice field is primarily experience-based. We believe that through various methods, we have acquired valuable insights into the recipients’ and providers’ needs, adding to the external validity of the PBI.

The involvement of stakeholders and experts in the development process established a vital connection between researchers and the clinic, which is known to enhance stakeholder ownership and the usability of the intervention in clinical practice [44, 45]. However, a limitation of the development process is that participants in the Consensus Conference provided feedback solely on the specialised intervention algorithm rather than the overall PBI. Experienced SCNs likely have established structures for their consultations that may not be easily amendable to change. To address this and further strengthen the connection to clinical practice, we plan to consult a group of experienced SCNs outside our clinic to obtain their feedback on the structure of the nursing consultation. This feedback is pending before we initiate a feasibility study. Additionally, emphasis will be placed on providing information, education, and training to SCNs regarding the PBI prior to the feasibility study. In accordance with the four stages of the MRC Framework, conducting a feasibility study constitutes the next step, which will later be followed by phases of evaluation and implementation [26–28].

Using theoretical frameworks [40] provided important structure and content for the PBI strategy, which was necessary to accommodate the complexity of the many details and elements of the PBI. We included the main elements of the CAIIN model, except for the ‘behaviour and relationship’ element, which was deemed a basic nursing requirement. Sensitivity to the needs of the patient was included in the first PBI principle for uncovering symptoms and problems. Hence, the strategy provides SCNs with a guide to support them in having a systematic approach in their consultation [21, 23] as well as involving the patient in the treatment [10, 23, 41] by facilitating a safe and empowering environment [15, 21, 41], all of which is crucial to enable appropriate use of the PBI.

Throughout the entire process, we have kept track of all content, adjustments and modifications leading to the final results to ensure transparency and quality throughout the whole process. For the generalizability of the PBI, content that was not considered relevant to most patients with parastomal bulge was discarded in the consensus conference, local workshop with SCNs or by the research team. Examples of such content are suggestions from patients that were too personalised (e.g. avoiding ice cream late in the day), interventions deemed too technically demanding for wider applicability (e.g. sports tape to ensure better fit of a base plate) and interventions that were not applicable in practise (e.g. provide a hotline only for patients with parastomal bulge). We acknowledge that some of these suggestions may work in clinical practice and for specific patients, underlining the importance of involving patients in their treatment plan.

We believe the content and structure of the PBI are generalisable to outpatient clinics in Denmark. However, we expect the PBI to be modified after clinical testing and evaluation in an upcoming study testing the feasibility and acceptability of the intervention in patients and SCNs. The generalizability of the intervention outside Denmark may depend on the structure and clinical set-up, including the staffing of outpatient stoma clinics, resources and time for nursing consultations. The transferability to other settings may be known in more detail once the PBI has been tested and evaluated. However, we expect the intervention to be best generalisable to Western countries, as the majority of the literature included in the scoping review that informed the structure of the PBI originates from regions such as Western Europe, North America and Oceania (New Zealand).

Conclusion

Managing patients with a stoma complicated by a parastomal bulge is complex due to the involvement of various nursing interventions. These interventions can be employed to manage multiple symptoms simultaneously, and often, several interventions may be required to address a single symptom. The MRC framework was successfully applied to develop a program theory of complex nursing interventions for patients with a parastomal bulge.

By incorporating elements from Bleijenberg in the development phase, we ensured that both recipients’ and providers’ needs were represented in the programme, strengthening the fit to clinical practice.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Abbreviations

SCN

Stoma care nurse

MRC

Medical research council

CAIIN

Consultation assessment and improvement instrument for nurses

PBI

Parastomal bulging intervention

Author contributions

All authors contributed to the development of the intervention. MK conceptualised and designed the study. MK and CL led the workshops and the Consensus Conference. MUP facilitated the three workshops. CL kept track of all content, adjustments and modifications while TBB and MUP provided clinical inputs throughout the process. All the authors (MK, CL, TBB, MUP, PD) contributed and were central to the data analysis and the design and modelling of the intervention. MK drafted the manuscript, CL contributed to the preparation of the manuscript. PD supervised the process of working with the MRC framework. All authors read and approved the final manuscript.

Funding

The Novo Nordic Foundation NNF220C0079917 funded this study. The funding had no impact on the study protocol, design or other aspects of the study.

Data availability

The datasets generated and analysed during the current study are not publicly available due to GDPR. However, aggregated data from the workshops and the consensus conference are included in the Additional files 2 and 3.

Declarations

Ethics approval and consent to participate

We conducted the study following the Helsinki II Declaration. According to Danish regulations, the study did not require ethical approval (https://researchethics.dk/about-the-danish-national-committee-on-health-research-ethics-nvk/rules-of-procedure-for-the-danish-national-committee-on-health-research-ethics). Participants in the Workshops and Consensus Conference received oral and written information before signing consent forms. All data were handled with confidentiality and stored safely and pseudo-anonymously according to current guidelines. The workshop study was approved and registered at ‘The Region Zealand Record of processing activities related to scientific research projects’ (REG-009–2024).

Consent for publication

All participants provided consent for publication.

Competing interests

The authors declare that they have no competing interests.