The survey comprised 25 questions and covered best practices in assessing patients' body and stoma profiles, product needs and preferences, tools used to assess quality of life and skin integrity, and topics derived from the literature review. The survey asked respondents about issues they considered in decision-making for management of the patient with a stoma and their use of the body and skin profiles and stoma assessment. The body and stoma profile assessment is a systematic process used to evaluate the area around the stoma (regular, inward, or outward shaped), the softness of the peristomal area (soft or firm), irregularities of the peristomal area (creases/folds), location of the stoma when bending, and the position of the stoma opening (skin level, above or below skin level).20 The survey also explored patient engagement, patient education, frequency of patient follow-up, what practice guidelines if any, were utilized, and how patient quality of life factored into product choice and decision-making.
Results from survey 1 were analyzed by the panel and review group during a series of virtual dialogues utilizing an affirmative facilitation methodology,21 and a second survey (process stage 2) was created. This second survey resulted in a response rate of 30% (n = 285; all responses were anonymous). Results from survey 1 and 2 were analyzed and a 3rd survey was sent to the panel and expert review group to test the consensus results against the literature. Results from all 3 surveys were then presented to the panel and expert review group at a face-to-face meeting where the resulting consensus was translated into a set of practice guidelines. The practice guidelines were presented to 960 ostomy nurses at Ostomy Days, an international education program hosted by Coloplast in Copenhagen, April 2018. Ostomy nurses from 27 countries were present, including countries who were not part of the Delphi survey process, like China and Spain. The 960 nurses ratified the practice guidelines and then participated in a facilitated dialogue to reach consensus on how to implement, operationalize, and educate others on the practice guidelines. The sample sizes for each process stage and languages are reported in Table 2.
Data Management and Analysis
Survey data were combined as a total sample, included 1225 individual responses, were analyzed using SPSS Statistical Software (Statistical Package of Social Science, Armonk, New York), and results reported as means and medians. Themes such as coping mechanism were derived from narrative data using thematic analysis, which is a process of identifying patterns or themes within the data. Analysis by geography was not possible due to the anonymity of survey responses. Given that participants were able to choose the language in which to respond to the survey, analysis by language group did not necessarily correspond to geographic boundaries or regions.
Institutional Review Board (IRB) approval was provided without qualifiers by Asentral IRB. All surveys were 100% anonymous, with no way for survey responses to be linked to respondents. Demographic information collected focused on clinical credentials and type of clinical practice. No individual patient information was collected. While Coloplast A/S was the sponsor and funded the study, the research questions, project oversight, and resulting consensus-based practice guidelines were created by the expert panel and international review groups, independent of the sponsor. Coloplast products were not mentioned in the surveys or in communication with participants. The resulting guidelines do not reference or recommend any particular product; rather, they focus on how to assess and utilize the type of pouching system best suited for the patient.
The outcome of the consensus process identified key factors to be considered when helping the person with an ostomy determine the best product choice (Figure 3). Consensus was reached on overall principles, identification of patient assessment guidelines as well suggestions about patient engagement, education, and the frequency of contact with an ostomy care provider.
Principles That Guide Patient Assessment
- Pouch security and peristomal skin health
- 72% (667/926) of respondents indicated that pouch seal security and maintaining peristomal skin integrity were the most important factors in decision-making when determining product choices.
- Assessment of body profile
- 94% (267/285) of respondents stated that body and stoma profiles should always be assessed when choosing an ostomy product.
- Product choices
- 95% (271/285) of respondents indicated assessment of the patient's body and stoma profiles can help determine which product will provide patients with the highest level of confidence and security.
- 65% (602/926) of respondents reported that the most common reasons for a product change (a new product) are pouch seal leakage and peristomal skin complications.
Patient Assessment Guidelines
- Assess the peristomal area using a validated body profile assessment tool22 for:
- regular, inward, or outward
- uniform or variable
- soft or firm
- presence of superficial creases or deep folds examined in sitting and standing positions
Body and stoma profiles: In addition to the peristomal skin health, the body and stoma profiles should be assessed at every product change. Patients should be instructed on how to accurately assess their peristomal skin at every pouching system change, which can help to identify problems for which patients should seek help from an ostomy nurse. When the ostomy nurse changes a product, he or she should always assess peristomal skin health, preferably with a validated skin assessment tool. Product selection should not be made on the basis of provider preference, a set order of products (ie, start with a flat product and if not successful move to a convex product), or through trial and error. Other methods to aid in assessment include a decision tree for clinicians, a patient self-assessment tool, patient body profile diary, a photo assessment guide, and information gathered from websites that provide evidence-based protocols.
- location: above, at, or below the line where the abdomen folds when bending
- lumen (opening) location: above, at, or below the peristomal skin level
- protrusion: present, absent, or below skin level
- shape and diameter
- output type and volume
The aforementioned assessments help determine the body and stoma profiles and assist with the decision if a flat, convex or concave, precut or cut to fit skin barrier is best suited for the patient. In addition, that patient's health and quality of life goals, capabilities, and support should be considered when making the clinical judgment. The assessment of the patient's body and stoma profiles, the type and volume of output, and patient-related issues will provide the information to make a decision on the best product and accessory combination for patient security and confidence.
Principles That Guide Patient Care
- Instruct patients to identify changes in their body and stoma profiles and when to seek assistance from the ostomy nurse. Ostomy nurses need to engage and educate patients by:
Maintain frequency of patient contact:
- encouraging them to be proactive in their own health
- providing access to and education on tools that assess their body and stoma profiles, and peristomal skin health, and know when to seek assistance from an ostomy nurse
- helping them set realistic goals to reach optimal health and quality of life
- within 2 weeks of postoperative hospital discharge following stoma creation or revision to reassess the patient's body and stoma profiles and determine which pouching system will provide the best security (fit) and confidence
- within 2 weeks after a product change or modification to determine product efficacy and what action should be immediately taken if security is still not achieved
Additional Supportive Information
The majority of nurses who responded to the surveys reported that they sometimes or often witness their patients with ostomies using the following coping mechanisms (Figure 4) to manage their lack of confidence in their pouch security by:
- decreasing physical activity
- decreasing physical intimacy
- decreasing socialization
- significantly reducing hobbies and other social activities
- leaving house for short periods of time only
- not staying away from home overnight
Respondents indicated that experiencing leakage was the number 1 reason reported by patients' (Figure 5) withdrawal from physical, leisure, and social activities; 57% observed withdrawal from social and leisure activities after a series of pouch seal leakages or an embarrassing social situation caused by their stoma. A majority, 95% of respondents believed it is part of the ostomy nurse's job to ensure that a person with an ostomy is able to experience an optimal quality of life. However, 13% reported they do not measure quality of life whereas 61% reported assessing quality of life by performing prestoma site markings but after group discussion it was concluded that stoma site marking is not a measure of quality of life. Of the 77% that do assess quality of life, only 24% report using validated quality–of-life instruments and 52% said they do not use a skin or stoma assessment tool.
We report findings from a large-scale Modified Delphi Consensus-Building Process project used to identify key factors in assessing body and stoma profiles to determine the best pouching system to reduce and or prevent leakage and peristomal skin complications in persons with an ostomy. This process project resulted in the development of practice guidelines that provide expert guidance on how to assess body and stoma profiles, how to engage and educate patients, and when to follow up with patients after hospital discharge or product change. The overall goals were to decrease leakage, provide security and confidence, with the long-term objective of improving quality of life.
Consensus among the ostomy nurse respondents indicated that pouch seal security and maintaining peristomal skin integrity are the most important factors in decision-making when determining product choices. This is supported in the literature by multiple authors who report up to 80% of patients with an ostomy develop peristomal skin issues,2–5 that leakage is a major problem that leads to peristomal skin problems,23 and results in lack of confidence in living with their stoma.22,24 The respondents defined patient assessment guidelines that included the assessment of the peristomal area, stoma, output, patient preferences and abilities, and that these assessment parameters should be used in the selection of the most appropriate pouching system for patient security. It was clear from the results of our survey and data gathered, during the face-to-face panel and expert review group dialogues, that increasing patient quality of life by determining the best pouching system to decrease or prevent pouch seal leakage is the ultimate goal for the person with an ostomy.25 To achieve this goal, pouching system security and optimizing peristomal skin health are paramount.
All ostomy nurse survey respondents recommended that to increase stoma security, peristomal skin health and patient confidence, patients must be educated and actively involved in their stoma care. Engaging patients in assessing their own peristomal, body and stoma profiles at every pouch change, educating them to recognize changes in their peristomal skin health, and encouraging them to contact their ostomy nurse when peristomal changes occur are cornerstones of the guidelines, as they were identified as critically important in effective stoma care. Respondents also identified the need to use validated tools to assess body and stoma profiles, peristomal skin health, and quality of life to ensure patients are fitted with the pouching system that will promote peristomal skin health and provide a high level of security and confidence.
Strengths and Limitations
The strength of the project was the large number and geographical diversity of the respondents, making the results applicable to persons with ostomies worldwide. The Modified Delphi Consensus-Building Process, which was developed and led by an International Association of Facilitators, Certified Professional Facilitator, provided an unbiased approach to develop the surveys, administer them, and analyze results. Another strength was the depth and experience of the expert panel and the expert review group, all of whom were highly skilled ostomy nurses involved throughout the entire project processes. There was wide representation from many countries and languages, including Spanish-speaking nurses at the Ostomy Days Dialogue. A limitation was the inability to send the survey to China (China lacks the email platform to participate in an email survey), but ostomy nurses from China did participate in the Ostomy Days ratification process. Another limitation of the study was that the consensus was only obtained from more developed countries such as North America, Europe, and Australia. Finally, industry sponsorship could lead participants to bias toward Coloplast products; however, all survey questions and the resulting practice guidelines focused on type of pouching system (flat, convex, and concave) not brand, decreasing bias as a factor in the study.
We describe the process for, and outcomes of, the development and dissemination of consensus guidelines that provide guidance for nurses providing ostomy care. Lack of a secure pouch seal leads to peristomal skin problems and is one of the major reasons that persons with ostomies experience a lack of confidence in managing their ostomies. Ostomy nurses should ensure persons with ostomies experience as few pouch seal failures as possible, by providing their patients with the best fitting pouching system, in order to promote peristomal skin health and help the patient develop and maintain confidence in managing their ostomies. Assessing the patient's peristomal body and stoma profiles and utilizing the product type best suited to provide ultimate security and comfort is critical. Engaging and educating patients and families in proactively assessing body and stoma profiles and peristomal skin health at every product change is important to ensure early detection of peristomal changes and pouching seal problems and to insure patient confidence in living with their stoma. We propose that this work serve as a tool for ostomy nurses to provide guidance on choosing the best pouching system using these consensus guidelines.
- A consensus document was developed that identified key factors in assessing body and stoma profiles to determine the best pouching system to reduce and/or prevent leakage and peristomal skin complications.
- Pouch seal security and maintaining peristomal skin integrity are the most important factors in decision-making when determining the selection of a pouching system.
- Body and stoma profiles and the patient's health, quality-of-life goals, capabilities, and help managing the stoma (if needed) should always be assessed when choosing an ostomy product.
- The most common reasons for a product change are pouch seal leakage and peristomal skin complications.
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Keywords:© 2019 by the Wound, Ostomy and Continence Nurses Society.
Body and stoma profiles; Consensus; Ostomy; Peristomal skin complications; Pouch leakage; Pouching system; Peristomal assessment; Stoma assessment