Volume 42 Number 4

Introduction

For people living with an ostomy, the risk of leakage and peristomal skin complications (PSC) are typical concerns. It has been estimated that 91% of people living with an ostomy worry about leakage and 76–77% have experienced leakage within the last 6 months^1,2. Worrying about leakage may challenge everyday activities and social interactions; further, leakage is a major contributor for developing PSC.

In one study, four main diagnoses (faeces-induced erosion, maceration, erythema and contact dermatitis) accounted for 77% of all ostomy-related diagnoses, and these were all related to contact with ostomy effluent³. When the integrity of the skin is damaged, adherence between the skin and the ostomy product is challenged, potentially leading to further leakage⁴. As a result, pain, anxiety and a loss of confidence in the ostomy product may occur, leading to a risk of less participation in social activities and a negative impact on the individual’s quality of life¹.

Lack of awareness of PSC seems to be common. A study reported that less than half (43%) of the individuals with PSC were aware of the problem⁴. Improving awareness of risks factors that may lead to leakage and PSC among people living with an ostomy has a great potential to help preventing PSC.

Several factors in addition to those inherent to ostomy products may predispose people living with an ostomy to PSC^4,5. Some of these risk factors can be addressed at routine visits to the clinic to increase awareness in people living with an ostomy and initiate mitigating actions as part of a prevention strategy against PSC. Identification of these risk factors may also give rise to new interventions for preventing leakage and PSC in people living with an ostomy.

The concept of a consensus-based PSC risk factor model was identified as a potential solution to increasing the awareness of which risk factors can be intervened upon to prevent the development of PSC. The purpose of the research presented here was to develop consensus on the most important risk factors for PSC and incorporate them in a risk factor model, while simultaneously identifying evidence and gaps in the literature pertaining to these risk factors. The aim is to guide practice in ostomy care and support healthcare professionals and people living with an ostomy in the prevention of PSC. We hypothesised that the development process of a comprehensive PSC risk factor model to support daily practice in preventing PSC will highlight a gap of good or high quality evidence from the literature to support the model.

Methods

Development of the risk factor model

The risk factor model for PSC was developed in collaboration with the Coloplast Skin Expert Panel (consisting of seven experts in the field of dermatology, wounds and ostomy care), the Global Coloplast Ostomy Forum (Global COF), an exclusive entity consisting of 13 internationally recognised experts, and the national COF boards. The national COF boards represent more than 400 ostomy care nurses from around the world, including Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Italy, the Netherlands, Norway, Poland, Slovakia, Sweden, the United Kingdom, and the United States of America.

The development of the risk factor model for PSC was a multistep process with four main stages, namely scoping, exploring, convergence and ratification (Figure 1).

Figure 1. Method for development of the risk factor model for PSC.
A. Step 1: Scoping stage. Meetings were held to brainstorm on risk factors for PSC with the Skin Expert Panel, Global COF, national COF boards and internally in Coloplast with experts in ostomy care from R&D and Marketing. Discussions with the Skin Expert Panel and Global COF based on a scoping literature review guided the further process Steps 2 and 3.
B. Step 2: Exploring stage. After all the data gathered in Step 1 had been grouped into 10 themes by the internal Coloplast skin project group, the Skin Expert Panel, Global COF, and national COF boards condensed the 10 themes even further, resulting in three overall categories to be outlined by the Coloplast skin project group.
C. Step 3: Convergence stage. The three categories were presented to the Expert Skin Panel and Global COF before discussions in the national COF boards aimed to align the content and name the three categories, and the Coloplast internal skin group adjusted the three categories to a final draft. In parallel, a systematic literature review was performed to support discussions and consensus building. The Skin Expert Panel and Global COF agreed to the final draft before an international consensus process resulted in the final version.
D. Step 4: Ratification stage. The final risk factor model for PSC was ratified by the Expert Skin Panel and the Global COF.

In Step 1 (the scoping stage), an initial meeting was held with the Skin Expert Panel to brainstorm risk factors for PSC. The panel members individually made suggestions for risk factors; further discussions within the panel helped identify additional risk factors and risk factor categories. This process was repeated with the Global COF, the national COF boards, and internally at Coloplast with ostomy care experts from the Research and Development (R&D) and Marketing departments. In parallel, a literature search on PSC risk factors was conducted. The results of this search were shared with the Skin Expert Panel and the Global COF to guide the next steps.

In Step 2 (the exploring stage), an internal Coloplast skin project group categorised all data gathered from the different expert panels in the scoping phase into themes. These themes, with interlinked risk factors, were presented to the Skin Expert Panel, Global COF, and the national COF boards, and they were each tasked with further condensing these themes into overall risk factor categories.

In Step 3 (the convergence stage), the overall risk factor categories were presented to the Skin Expert Panel and the Global COF before discussion sessions were held within the national COF boards to align the content and nomenclature of these categories. The Coloplast internal skin project group updated the categories based on the input from the national COF boards and prepared a final draft. Agreement on this draft was obtained from the Skin Expert Panel and the Global COF before an international consensus process was conducted, resulting in the final version of the risk factor model^6,7. The consensus process is described in detail in a separate publication⁷. Briefly, using a modified Delphi process, consensus was reached among ostomy care specialists across 35 countries. This stage was supported by a systematic literature review (see description below) to identify the level of evidence behind each identified risk factor. In Step 4 (the ratification stage), the final risk factor model was ratified by the Skin Expert Panel and the Global COF⁷.

Literature review

A systematic review was performed during the convergence stage to support the discussions and consensus building and ascertain the level of evidence behind the identified risk factors. The literature search was performed by an information specialist using the PubMed (including Medline), Derwent World Patents Index, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The searches were performed on 19 June 2020 (PubMed and Derwent) and 19 August 2020 (CINAHL).

The search timeline was restricted to articles published between 2000 and 2020 (August). The time interval was chosen based on receiving relevant published literature; 10 years was considered a too limited time interval to receive an optimal amount of relevant literature within ostomy care. The search was made sufficiently broad by searching for text words related to skin descriptors and combining these with skin issue and ostomy synonyms. Furthermore, search terms were mapped to the following Medical Subject Headings (MeSH) in Medline: skin, dermatitis, dermis, epidermis, dermatologic agents, ostomy, colostomy and ileostomy. The search strings generated were combined with Boolean operators (AND, OR) to arrive at the final results (Figure 2).

Figure 2. Method for the literature search: search strings.

The study selection process is depicted via a PRISMA flow chart in Figure 3. Duplicates were identified manually based on titles and abstracts. These were removed, and thereafter the remaining references were independently screened by two authors based on titles and abstracts. The title or abstract would include words related to ostomy/stoma and problems or PSC to be included. The two independent screenings were compared, and a list of articles made based on the agreed selection. If there was doubt about the relevance of an article, a third author was consulted. The selected articles were evaluated based on exclusion criteria such as reviews, overviews, case studies/case series with less than 10 subjects, opinion pieces, editorials, conference abstracts, and book chapters; the aim was to find published primary literature providing clinical evidence to support the risk factor model. Articles written in languages other than English were also excluded. Thereafter, the full-text versions of the remaining articles were read and studies included if evidence for the identified PSC risk factors were described and both reviewers agreed on the inclusion. Lastly, the evidence quality of the selected articles was evaluated using a 3‑point scale adapted from John Hopkins evidenced-based practice methodology⁸. The selected articles found to support the risk factor model were consolidated and approved by the Coloplast skin expert panel and the Global COF.

Figure 3. Method for the literature search: PRISMA flowchart

Results

Risk factor categories from the risk factor model

In Step 1 (the scoping stage) of the PSC risk factor model development, more than 100 risk factors were identified. In Step 2 (the exploring stage), these were condensed into 10 ensuing themes: skin-related; user characteristics; resources; environment; mental compliance and adaption; stoma and body profiles; output properties; product usage, compliance, and routines; product performance; and training and education. These 10 themes with interlinked risk factors were condensed further with the help of the expert panels (the Skin Expert Panel, Global COF and the national COF boards) resulting in three suggestions for the overall risk factor categories – Healthcare system, Individual with an ostomy, and Ostomy product (Figure 4).

In Step 3 (the convergence stage), the content and nomenclature of the three categories were refined further, resulting in 24 risk factor subcategories (Figure 4). In Step 4 (the ratification stage), these risk categories and subcategories were ratified by the Skin Expert Panel and the Global COF to constitute the final risk factor model.

Figure 4. The risk factor model for PSC

Literature search results

Based on the combined searches, 3216 references were found (Figure 3). After removing 844 duplicates, 2372 articles were screened by title and abstract, and 235 read and screened for the final selection. It was not possible to retrieve four articles; they were therefore excluded. Four articles^9–12 did not display any statistics but were included because of their relatively large sample sizes, ranging from 18–796 subjects. In total, 58 articles were included in the review, supporting 19 of the 24 risk factor subcategories identified. Of the included articles, 27 were found to fit into the Healthcare system category^11,13–38 (with 32 citations within this category), 43 into the Individual with an ostomy category^{4,5,9,12–19,22,24–28,30–32,34–37,39–57} (74 citations), and 13 into the Ostomy product category^{9,10,25,39,41,55,58–64} (16 citations); several articles were found to fit into two or more categories or subcategories. The articles were divided into three evidence levels⁸: Level I (high), five articles^{38,51,54,61,64}; Level II (good), 43 articles^{4,10,12–22,24–37,41,44–50,52,53,55–60}; and Level III (low), 10 articles^{5,9,11,39,40,42,43,62,63}. A list of the individual studies supporting each identified risk factor within each risk factor category is available in Appendix 1.

Risk factor categories

Healthcare system

The Healthcare system category included seven system level PSC risk factors related to contact, guidance and input from the healthcare system (Figure 4). In the literature review, 27 articles^11,13–38 (one Level I³⁸, 24 Level II^{13–22,24–37}, two Level III^11,23), with 32 within-category citations, were found supporting five of these seven risk factors (Appendix 1).

Among the individual risk factors in this category, preoperative guidelines include guidance on preparing the patient for the surgical procedure, marking the spot for the ostomy, and advising the patient on life with an ostomy post-surgery; seven articles^{14,16,21,27–29,33} (all Level II) were found to support the importance of preoperative ostomy site marking as a risk factor for developing PSC.

Surgical guidelines include best practices for creating ostomies for the best possible patient outcome; 19 articles^{13–15,17–20,22,24–27,30–32,34–37} (all Level II) were found providing clinical evidence for surgical techniques and indicating the importance of selecting a surgical procedure that reduces the risk of getting PSC. Care guidelines include high quality postoperative training and follow‑up; three articles^21,23,38 (Level I, II and III: one each) were found pertaining to guidelines for ensuring the quality of postoperative training of the patients. Post-discharge programs include whether health insurances and healthcare systems provide access to follow-up programs; two clinical trials^29,38 (Level I and II: one each) were found to provide evidence on the importance of adequate access to post-discharge programs and demonstrated that support from healthcare professionals post-discharge as well as pre‑surgical education of the patient decreased the risk of developing PSC.

Healthcare professionals as a risk factor subcategory include the general level of education, access to further education, and the type of care and surgical procedures undertaken; one qualitative study¹¹ (Level III) discussed the importance of the level of education of healthcare professionals to provide optimal support to the patient. Other risk factors in this category were access to appropriate ostomy product types and quantity to cover any needs, and societal view of people with chronic conditions; no supporting evidence was found for these subcategories.

Individual with a stoma

In this category, a total of 10 individual level risk factors for PSC were identified (Figure 4). The literature review identified 43 articles^{4,5,9,12–19,22,24–28,30–32,34–37,39–57} (two Level I^51,54, 35 Level II^{4,12–19,22,24–28,30–32,34–37,41,44–50,52,53,55–57}, six Level III^{5,9,39,40,42,43}), cited 74 times, supporting nine of these 10 risk factors (Appendix 1). One of these, peristomal body profile, includes whether the peristomal area has a regular, inward or outward (bulging) profile and informs the selection of the most appropriate ostomy products to provide the right fit and a secure seal. Nine articles^{9,15,27,32,35,40,42,48,56} (six Level II, three Level III) were found to support peristomal body profile, including a high body mass index (BMI) and parastomal hernias, as an important risk factor for PSC. Ostomy construction indicates how ostomy height and location may impact the adherence and fit of the ostomy product; 18 articles^{9,12,13,17–19,22,24,27,30,31,34–37,41,47,50} (17 Level II, one Level III) were found dealing with the importance of ostomy construction in terms of appropriate diameter and height as well as the optimal surgical technique. Ostomy output type is a PSC risk factor depending on the output consistency and volume; 20 articles^{4,5,12,14,16,18,25–28,39,41,43,45,46,49,52–54,57} (one Level I, 16 Level II, three Level III) found evidence that an ileostomy increases the risk of PSC when compared with other ostomies.

The individual’s skin properties/conditions may also have an impact on PSC as the skin can be sensitive, dry, fragile, greasy, or oily, or have creases, scars, folds, wounds or underlying diseases; three articles^41,42,54 (Level I, II and III: one each) alluded to skin properties/conditions as risk factors for developing PSC, particularly in terms of impaired mechanical quality of the barrier, skin creases, or age of the patient. Medication/treatment as a PSC risk factor includes side effects from immunosuppressive treatment, steroids, radiation therapy and chemotherapy; six articles^{15,26,32,36,55,57} (all Level II) showed chemotherapy and conditions such as diabetes to be risk factors for PSC. Both age and disabilities were identified as risk factors. Disabilities that may potentially and adversely impact on PSC are factors such as poor eyesight, low hand dexterity, or being a wheelchair user; nine articles^{5,18,25,28,35,36,40,48,57} (seven Level II, two Level III) identified age as a risk factor for PSC.

Self‑consciousness/self-care was also deemed to have an impact on PSC as denial or lack of coping skills could affect ostomy management and the ability to adapt to new life conditions; five articles^{5,14,18,31,35} (four Level II, one Level III) related to this subcategory were found, particularly those dealing with gender as a risk factor for PSC. Ostomy management is a risk factor depending on the individual’s ability to perform ostomy care techniques and routines in personal ostomy care practice; three articles^9,41,51 (Level I, II and III: one each) showed the importance of ostomy management skills. Support from family or the individual’s social network to provide help was identified as another risk factor as was the individual’s standard of living, e.g., living conditions, level of income, hydration and nutrition, which may impact ostomy management; one article⁴⁴ (Level II) supported standard of living as a risk factor displaying an impact of social restriction. No articles providing evidence for support from family/social network were found.

Ostomy product

The consensus development process identified seven product level PSC risk factors (Figure 4). In the literature review, 13 articles^{9,10,25,39,41,55,58–64} (two Level I^61,64, seven Level II^{10,25,41,55,58–60}, four Level III^9,39,62,63), cited 16 times, were identified as supporting five of these seven risk factors (Appendix 1).

An identified risk factor, fit to the ostomy shape, highlights the fit between the pre-cut hole in the wafer and the ostomy; two articles^9,41 (Level II and III: one each) were found providing evidence for this risk factor subcategory. Wear time is a risk factor for PSC, including how the chosen ostomy product will match the recommended and preferred wear time; three articles^39,41,55 (two Level II, one Level III) were found dealing with issues related to wear time. The range and type of products accommodating individual needs, peristomal body profiles, and the type of ostomy output are considered PSC risk factors; three articles^25,39,63 (one Level II, two Level III) were found describing, for example, the importance of accommodating individual needs to minimise PSC risk (e.g., by using a convex product).

The adhesive property of the ostomy product is a risk factor as it impacts adherence to the skin, moisture absorption and erosion; seven articles ^{9,10,58–61,64} (two Level I, four Level II, one Level III) were found describing how different components in the adhesives affect the peristomal skin. Filter performance and capacity of the ostomy product are also risk factors determining the ability of the ostomy product to retain solids and liquids and prevent ballooning or pancaking; only one relevant article⁶² (Level III) was found in this category. The fit to the body profile, which concerns how the ostomy products adapt to the peristomal body profile, and the ease of application or removal of the ostomy product, were also identified as PSC risk factors; however, no supporting articles were found in the literature.

Discussion

The research presented here depicts the development of an international consensus-based risk factor model for PSC which resulted in 24 risk factors organised in three overall categories, namely those at the system level (Healthcare system), individual level (Individual with an ostomy), and product level (Ostomy product). A systematic literature review identified 58 articles providing evidence for 19 of the 24 risk factors; it also highlighted the gap in good or high quality evidence for specific risk factors included in the model.

In recent years, ostomy products have been the subject of innovation and development to improve the fit or the performance of the ostomy pouching system. However, recent research showed that leakage and PSC are still impacting peoples’ lives and causing worries among people with an ostomy^65,66. In a broader perspective, risk factors other than those inherent to ostomy products may offer unexplored opportunities to prevent leakage and skin issues by other means.

The consensus-based risk factor model for PSC gives an insight into which risk factors should be considered in the prevention of leakage and PSC. This risk factor model was developed in collaboration with ostomy care specialists, dermatologists and professors in wound and skin care representing 13 different countries. International consensus was reached among ostomy care specialists across 35 countries using a structured modified Delphi process. The large number and geographic diversity of the participants make this risk factor model unique in the field of PSC, allowing for regionally appropriate emphasis and implementation variations based on system requirements and patient expectations.

A systematic literature review demonstrated the evidence base for the identified risk factors, further strengthening and consolidating the model. For this systematic review, a broad search was conducted in several databases, and study selection was performed independently and thereafter aligned by two different reviewers, making the process robust and the quality of the review sound. By excluding study designs furnishing low levels of evidence, including case studies/series with <10 subjects, the quality of evidence of the included studies seems reasonable. The included studies were also quantitative in nature (except four articles^9–12), providing statistical evidence for the risk factors. Therefore, the identified primary articles are believed to display an adequate level of clinical evidence (majority classified as Level II) to support the risk factor model, particularly in a field that is believed to be sparse on clinical evidence.

Among the three overall categories in the model, Individual with an ostomy had the most supporting evidence with 43 articles^{4,5,9,12–19,22,24–28,30–32,34–37,39–57} (74 citations). In general, most of the individual level risk factors included in this category were well supported by good quality evidence (mostly Level II), including BMI or hernia (peristomal body profile)^{9,15,27,32,35,40,42,48,56}, age (disabilities)^{5,18,25,28,35,36,40,48,57}, ostomy height/diameter (ostomy construction)^{9,12,13,17–19,22,24,27,30,31,34–37,41,47,50}, and surgery type (ostomy construction^{9,12,13,17–19,22,24,27,30,31,34–37,41,47,50}; these citations overlapped with surgical guidelines)^{13–15,17–20,22,24–27,30–32,34–37}; ileostomy (ostomy/output type)^{4,5,12,14,16,18,25–28,39,41,43,45,46,49,52–54,57}, as patients with an ileostomy have a higher risk of developing PSC; and gender (self‑consciousness/self-care, though gender as a risk factor could be conditioned by cultural differences rather than a difference in genders alone)^{5,14,18,31,35}. In addition, at least Level II evidence was found for an individual’s ostomy management skills^9,41,51, medication/treatment status^{15,26,32,36,55,57} (e.g., chemotherapy, diabetes), skin properties/conditions^41,42,54, and standard of living⁴⁴ being risk factors for PSC.

The Healthcare system was the next most supported risk factor category with 27 articles^11,13–38 (cited 32 times within the category) providing evidence for five of the seven system level risk factors included in this category. These articles primarily described clinical evidence for surgical techniques^{13–15,17–20,22,24–27,30–32,34–37} or preoperative guidelines^{14,16,21,27–29,33}, indicating the importance of accurate ostomy site marking and choosing the appropriate surgery technique.

In contrast, very few articles^21,23,38 could be found related to care guidelines for ensuring the quality of the postoperative training of the patients. Only two articles supplied evidence on how the healthcare system could provide support for the patient post-discharge^29,38. Nevertheless, these articles did show that support from healthcare professionals post-discharge and pre‑surgical education of the patient decreased the risk of developing PSC^29,38.

In the Ostomy product category, five of the seven product-related risk factors were accompanied by evidence from the literature (13 articles^{9,10,25,39,41,55,58–64} being cited 16 times). Apart from the ‘adhesive properties’ of the ostomy product (which was backed by seven articles^{9,10,58–61,64} providing mostly Level I^61,64/II^10,58–60 evidence), the rest of the identified risk factors were supported by three or fewer studies. Since these risk factors were identified by healthcare professionals and scientists as important for developing PSC, one could wonder why the clinical evidence on these aspects of ostomy product development is sparse. Nonetheless, the few articles identified in this risk factor category do indicate that both the type^25,39,63 and composition of an ostomy product^{9,10,58–61,64} are important in PSC development.

Overall, the risk factors pertaining to surgical technique (‘surgical guidelines’), ostomy output type, and ostomy construction had the most evidence from the literature with 19^{13–15,17–20,22,24–27,30–32,34–37}, 20^{4,5,12,14,16,18,25–28,39,41,43,45,46,49,52–54,57}, and 18^{9,12,13,17–19,22,24,27,30,31,34–37,41,47,50} related articles respectively. However, the majority of the articles in the surgical guidelines and ostomy construction categories overlap. Another 11 risk factors from the three overall categories (namely, preoperative ostomy site marking [preoperative guidelines], postoperative training of patients [care guidelines], peristomal body profile, the individual’s skin properties and conditions, his/her medication/treatment status, age [disability], self‑consciousness/self-care ability, ostomy management skills, range and type of ostomy products, adhesive property of the product, and product wear time) are also sufficiently described in the literature with evidence coming from three to nine studies.

Only five out of the 24 consensus-based risk factors identified in the model lacked any evidence from the literature. These include: system level factors such as access to appropriate ostomy product types and quantity, and the societal view of people with such a condition; individual level support from family or social network; and product level factors such as fit to the body profile and ease of application or removal of the ostomy product. While these factors are not supported by evidence from the literature, they are considered relevant and are internationally recognised based on expert opinion and experience. Combined with the five risk factor subcategories that were only supported by only one to two studies (namely, access to post-discharge programs^29,38, level of education of healthcare professionals¹¹, an individual’s income/standard of living⁴⁴, fit of the ostomy product to the ostomy shape^9,41, and filter performance and capacity of the ostomy product⁶²), these represent areas where further research is particularly needed.

It is a goal that the risk factor model for PSC can be used as a tool in daily practice in ostomy care. Some of the identified risk factors can be addressed at an early stage when the patient is discharged from the hospital and can save the patients from some of the initial issues they may face with a trial-and-error approach to self-care. The extensive and geographically diverse process of development of the model make it reasonably generalisable to population of individuals living with an ostomy and allow for regionally appropriate implementation variations. The model thus has the potential to be included in a healthcare professional assessment, intervention and monitoring guide to promote a holistic approach to ensure peristomal skin health and quality of life for people with an ostomy.

Conclusions

The purpose of developing a risk factor model on PSC was to explore existing evidence- and experience-based risks leading to PSC, with the purpose of providing a valid assessment method to guide individualised recommendations and decision making in ostomy care. The intention is to help prevent PSC.

By conducting a comprehensive literature research and by working with specialists in the field of ostomy care we have obtained a solid knowledge base upon which the risk factor model on PSC has been developed.

With the personalised risk factor assessment including quality of life, peristomal body profile and peristomal skin, hand in hand with a professional holistic judgement, a trial-and-error approach should be avoided to save the individual patient from severe negative impact on health and quality of life.

Conflicts of interest, source of funding

This work was supported by Coloplast A/S. Anne Steen Hansen, Cecilie Jæger Leidesdorff Bechshøft, Zenia Størling and Lene Feldskov Nielsen were employed by Coloplast A/S when the model was developed, and the manuscript was prepared.

Lina Martins, Jane Fellows, Birgitte Dissing-Andersen, Gillian Down, David Voegeli, Tonny Karlsmark and Gregor Jemec are members of the Coloplast Skin Expert Panel and have received honoraria for participating in different Coloplast Advisory Boards. They have not received compensation for involvement in this publication.

All authors were involved in the writing, reviewing and editing of the manuscript, gave final approval and agreed to be accountable for all aspects of the work. Anne Steen Hansen and Lene Feldskov Nielsen were responsible for the risk factor model for PSC and Cecilie Jæger Leidesdorff Bechshøft for the literature review. References were screened independently by Cecilie Jæger Leidesdorff Bechshøft and Lene Feldskov Nielsen.

Acknowledgements

The authors would like to thank the members of the COF and the Coloplast Skin Expert Panel who participated in discussions and shared their invaluable experience about PSC – Gemma Gascón Guitart who was part of the workshops in the beginning of the process and started the literature search in collaboration with Information Specialist Jette Brandt, M.L.I Sc, Library and Information Science, who conducted the literature searches, as well as Louise C. Rosenberg Christ, PhD and Kaushik Sengupta, PhD (Larix A/S, Copenhagen, Denmark) for editorial and medical writing services which were funded by Coloplast A/S.

Appendix 1. Literature supporting the identified risk factors.

Author(s)

Anne Steen Hansen*
BSc/MA, ET
Coloplast A/S, Holtedam 1, 3050 Humlebæk, Denmark
Email dkasn@coloplast.com

Cecilie Jæger Leidesdorff Bechshøft
PhD
Coloplast A/S, Holtedam 1, 3050 Humlebæk, Denmark

Lina Martins
NSWOC, BSc/MSc
London Health Sciences Centre, London, Ontario, Canada

Jane Fellows
MSN, RN, CWOCN-AP
Duke University Health System, Durham, North Carolina, USA

Birgitte Dissing Andersen
RN, Diploma in Nursing Management, ET
The Stoma Clinic, Herlev Hospital, Herlev, Denmark

Gillian Down
Diploma in Cancer Nursing, EBN (continence and stoma care), Reg. Midwife, RN, NHS
North Somerset and South Gloucestershire Clinical Commissioning Group, Bristol, UK

Tonny Karlsmark
MD, Sc
Bispebjerg Hospital, Copenhagen, Denmark

Gregor Jemec
MD, Sc
Roskilde Hospital, Roskilde, Denmark

David Voegeli
PhD, BSc, RN
University of Winchester, Winchester, Hampshire, UK

Zenia Størling
PhD
Coloplast A/S, Holtedam 1, 3050 Humlebæk, Denmark

Lene Feldskov Nielsen
MSc
Coloplast A/S, Holtedam 1, 3050 Humlebæk, Denmark

* Corresponding author

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