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The Italian Wellness Survey of More Than 1000 Ostomy Patients
Trends in Patient Adjustment After Stoma Placement
Trends in Patient Adjustment After Stoma Placement
Abstract
BACKGROUND: Despite technological advances to minimize the damage caused by ostomy surgery, patients face many physical and emotional challenges that can severely impact their health-related quality of life. PURPOSE: This survey monitored the wellness of patients with ostomies during their clinical follow-up through the 8-item Wellness Questionnaire, a simplified version of the validated Ostomy-Q. METHODS: The survey involved 1054 Italian novice and expert ostomy appliance users who had received a new device prescription (expert users changed to a new device due to problems with a previous device such as a change in weight or body profile and leakage). Patients were questioned at 2 time points: baseline (T0) and 4 weeks after stoma placement (T1). RESULTS: The overall Wellness Questionnaire score and the individual items generally improved from T0 to T1 for both types of users, suggesting that both novice and expert users face an adjustment phase for the ostomy device that impacts several aspects of their life. However, novice users were less concerned about social relations and skin irritation at both time points compared with expert users, whereas device visibility under clothes at T0 and social relationships at T1 were of lesser concern for experienced users than for novice ones. CONCLUSION: The Wellness Questionnaire, carried out by stoma therapists during the clinical follow-up of patients with ostomies, highlighted an overall improving trend 1 month after the device prescription for both expert and novice users. Both types of patients faced daily challenges related to the new ostomy device but from different perspectives. Further studies are needed to confirm the outcomes of this survey.
Introduction
An ostomy is a surgically created opening of a hollow organ on the surface of the body to enable the excretion of waste product when there is a need to temporarily or permanently divert the normal physiological excretion process.1 Following ostomy surgery, the normal bowel or bladder function is disrupted, and waste is passed through the abdominal wall through the stoma into an appliance that must be emptied periodically.2 Ostomies are classified according to their location: the intestine (colostomy and ileostomy) or bladder (urostomy).1,2 The most common indication for the creation of a colostomy is intestinal cancer, but inflammatory bowel disease, acute diverticulitis, traumatic events, and genetic diseases are also possible reasons.1,3 Likewise, urostomy is mainly a consequence of radical cystectomy performed to treat bladder cancer.4 In Europe, an estimated 700,000 people live with an ostomy5; in Italy, about 18,000 stomas are created annually with an average prevalence in the population of 0.13%.6
Despite technological advances to minimize the damage caused by ostomy surgery, patients face many physical and emotional challenges that can severely impact their health-related quality of life (QoL). Ostomy patients must learn to cope with the pouching system and adapt to the psychosocial consequences of living with an ostomy.7 Physical complications associated with ostomy surgery include peristomal skin irritation, which occurs in 21% to 70% of patients,8 as well as parastomal hernias (0–48.1%, depending on the type of stoma),9 stoma prolapse (2–3%),10 and stoma stricture and retraction.11 In addition, depending on the area affected, removal of large segments of the intestine and creation of an ostomy may impair absorption of nutrients, electrolytes, and fluids, resulting in nutritional deficiency.12 Other common physical complications are the absence of sphincter control, noisy bowel movements, changes in the passage of gas, odor issues during the pouch change, and social discomfort.13,14
In addition to these concerns, an ostomy causes significant disruptions that affect the psychological, social, and spiritual well-being of patients. Issues related to the use of ostomy appliances that have the greatest impact on ostomy patient’s life include daily care of the stoma and surrounding skin; correct pouch fitting; nutrition; elimination strategies; adjusting social routines to incorporate the demands of daily care; and dealing with anxiety, depression, and feelings of stigma.14-17 Moreover, the creation of an ostomy has an impact on body image, sexual function, mood, daily functioning, social activities, and relationships.18
Given the considerable physical, psychological, and social challenges of wearing an ostomy appliance, the impact of stoma devices on patients’ wellness warrants a comprehensive examination. As suggested by Nafees et al,19 identifying specific factors associated with poor psychological outcomes (ie, lack of discretion or comfort, low confidence, and negative impact on social life from stoma device use) may help improve stoma management and patient well-being. In this perspective, the validated questionnaire Ostomy-Q is considered to be the main tool to evaluate health-related quality of life (HRQL) in ostomy patients.19 However, the 23-item questionnaire is too long for everyday use by stoma therapists, especially during follow-up assessments conducted by phone.20 As an alternative, the author’s clinical practice developed a short version of the Ostomy-Q, called the Wellness Questionnaire, which included 2 items only for each domain.
The survey was designed for use at the 1-month clinical follow-up assessment of both novice and expert users of ostomy appliances. This 8-item Wellness Questionnaire analyzed daily challenges of wearing an ostomy appliance in relation to discretion, comfort, confidence, and social life. Today, most Italian stoma therapists use the questionnaire daily to gain insight into how ostomy patient challenges evolve over time and to guide implementation of effective intervention strategies.21
Methods
Participants. The present survey, carried out between January 2019 and September 2019, involved administration of the Wellness Questionnaire to 1054 Italian patients who had recently undergone colostomy, ileostomy, or urostomy surgery. The participants were classified into 2 groups: novice users (patients who had recently undergone placement of a stoma device for the first time) and expert users (patients who previously had an ostomy but required a change of device due to problems such as a change in weight or body profile and leakage). Patients with acute confusion and those who had dementia with deteriorating physical health were excluded from the survey. The project was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice. All participants provided written informed consent.
Survey design. Participating patients were administered the 8-item Wellness Questionnaire at the time the new device was prescribed and again after 4 weeks of use to assess how daily use of an ostomy device had affected their life. Information about the patient’s peristomal body profile22 and type of ostomy was also collected. The survey covered 4 domains of the patients’ experience with the ostomy device: 1) the discretion of the device; 2) the patient’s level of comfort while wearing the device; 3) the patient’s confidence in managing the device, and 4) the impact of the device on the patient’s social life.19Table 1 details the items in the Wellness Questionnaire, all of which were scored on a 5-point Likert scale ranging from 1 (totally negative experience with the device) to 5 (totally positive experience with the device). For each item, the average score was defined as high (score of 4 or 5), medium (score of 3 or 4), or low (score <3). The overall Wellness score was obtained by adding the scores of all 8 items; scores were categorized as high (score of 33–40), medium (score of 24–32), or low (score <24). Results were presented as a percentage of patient questionnaires reporting high, medium, or low scores for each item and for the overall Wellness score.
Wellness was evaluated at 2 time points: T0 (time of device prescription) and T1 (after 4 weeks of use of the prescribed ostomy device). This time was defined following the clinical practice of stoma therapists scheduling a follow-up visit about 1 month after the prescription of the device20; this period was considered sufficient to evaluate how the device’s use was affecting the ostomy patient’s everyday life.19
Outcome measures. Within each group of patients, the overall Wellness score at T0 was compared with that at T1 to determine any improvement. The scores for each item at T0 versus T1 were also compared to determine improvement in coping with each wellness aspect. Finally, the overall Wellness score at T0 versus T1 and the score for each investigated item were compared between the 2 patient groups (novice vs expert users).
Since findings from an interview study cannot be generalized to all persons living with permanent stomas, and the broad inclusion criteria defined could lead to bias, the results of the survey are presented with descriptive information only. Preliminary raw data may give a broad depiction of ostomy patients in Italy who are facing the challenges of living with such a device. The large number of people included in this survey may offer helpful insights to stoma care nurses about the most affecting challenges for novice and expert users.
Results
Of 1054 participants, 73% were novice users who had recently undergone their first ostomy procedure, and 27% were expert users who had had a change in device prescription due to some complications with the previous appliance. Regarding the shape of the area around the stoma, 50% of patients had a regular body profile whereas 28% had an outward profile and 22% had an inward profile. Most patients (47%) had had an ileostomy, whereas 31% had a colostomy and 22% had a urostomy (Figure 1).
Overall wellness score. About half of novice users (50.5%) had a medium overall Wellness score at T0 whereas 46.0% had a high score; only a small percentage (3.5%) had a low overall score at T0 (Figure 2A). At T1, the overall Wellness score of novice users improved: 72.4% had a high overall compared with 25.0% and 2.6% who had medium and low overall Wellness scores, respectively.
Approximately 54.9% of the expert users had a medium overall Wellness score at T0, 41.6% had a high score, and 3.5% had a low score; these proportions were similar to those recorded among novice users (Figure 2B). At 4 weeks after stoma device change (T1), expert users showed an improvement in overall wellness. The percentage of expert users with a high overall score increased to 65.5%; 34.5% reported a medium score, and no patient reported a low overall score.
Comparing the overall T0 Wellness score of novice and expert users, high scores were more common among novice users (46% vs 41.6%). The same trend was observed at T1, when wellness improved for both groups, but high overall scores were more frequently reported by patients who were novice users (72.4% vs 65.5%).
Single-item wellness scores
Novice users. At device prescription (T0), the social life domain was of least concern among novice users, with high scores reported for items related to daily activities and social relationships (63.3% and 75.6%, respectively; Figure 3A). In contrast, when considering the “comfort” of the device, the possibility of developing skin irritation under the appliance was a major concern for this group of patients; this item had the lowest percentage of participants reporting high scores (49.0%) and the highest percentage reporting low scores (31.3%). Interestingly, the second issue of the “comfort” domain addressed by the Wellness Questionnaire, the fit of the device in response to body movement, received high scores from 73.2% of the participants and low scores from only 10.5%, suggesting that this was not a major concern for patients using an ostomy appliance for the first time (Figure 4A).
Novice users gave positive scores even for “discreetness” and “confidence” domains; indeed, more than half of the patients reported high scores for being able to conceal the device under clothing (65.7%) and feeling unrestricted in their choices of clothing (64.7%) (Figure 5A). Similarly, most participants were confident about managing leakage problems (57.6%) and the loosening of the pouch from the body (58.5%) (Figure 6A).
Novice users showed improved scores for all analyzed items in each wellness domain after 4 weeks of use of the prescribed ostomy device (T1) (Figures 3A-6A). The highest number of high scores were reported in response to the item related to social relationships (88.2%; Figure 3A). Concerns about skin irritation, while improved over those expressed at T0, were still associated with the lowest frequency of high scores (65.8%) and the highest frequency of low scores (22.4%) among novice users (Figure 4A).
Expert users. Most expert users gave high scores to all 8 items of the Wellness Questionnaire at the first assessment (T0) (Figures 3B-6B). The highest percentage of high scores was given to questions related to the visibility of the device under clothing (82.8%), which belonged to the domain of “discreetness”(Figure 5B). Interestingly, the second question of the same domain, related to restrictions on clothing choices, had the lowest frequency of high scores (42.7%) and the highest frequency of low scores (41.1%). A low level of concern was reported for the social life domain, with the highest frequency of high scores reported for social relationship issues (77.9%) (Figure 3B); for the comfort domain, 68.3% and 65.6% of expert users gave high scores for issues regarding skin irritation under the appliance and device fitting to body movements, respectively (Figure 4B). Expert users reported high scores even for the confidence domain, such as concerns about leakage (52.0%) and problems with detachment of the pouch from the body (59.3%) (Figure 6B).
After 4 weeks of using the new device (T1), expert users reported improvement in all aspects of wellness except for concerns about the visibility of the device under clothing (Figures 3B-6B), for which the frequency of high scores decreased from 82.8% to 64.0% whereas the frequency of low scores nearly tripled (from 6.9% to 19.2%) (Figure 5B). In addition, limitations in clothing choice remained the main problem affecting patients’ lives, as demonstrated by the lowest frequency of high scores (55.2%) and the highest frequency of low scores (34.5%). Finally, expert users were those reporting the best outcomes in social relationships (93.1% of patients chose high scores, and none chose low scores; Figure 3B).
Novice versus expert users. The results of the survey showed that the initial concerns of patients prescribed a stoma device for the first time are less worrying for experienced users. More specifically, patients who had recently had their first ostomy procedure were most concerned about skin irritation problems (31.3% reported low scores compared with 18.3% of expert users) (Figure 4). On the other hand, the major concern among expert users was the restriction in clothing choices due to the ostomy device, with 41.1% of expert users reporting low scores versus 18.3% of novice users (Figure 5).
The experiences during the first 4 weeks after stoma device placement were different between the 2 participant groups, even for the items considered less challenging among novice and expert patients. At T0, the least disturbing issues for novice users were limitations in social relations (Figure 3A) versus visibility of the device under clothing for expert users (Figure 5B). At T0, expert users assigned high scores for the items about device visibility under clothing and detachment of the pouch from the body, as well as for skin irritation under the appliance and limitations in social relationships. On the other hand, novice users gave higher scores than expert users for the items related to limitations in clothing choice, device fitting to the body, device leakage, and performing daily activities (Figures 3–6).
At the second time point of wellness evaluation, both patient groups showed improved scores for each item examined, except for the item concerning the visibility of the device under the participant’s clothing. The most challenging aspects were problems with skin irritation for novice users (Figure 4A) and limitations in clothing choice for expert users (Figure 5B). Of note, concerns about maintaining normal social relationships became less important for both groups (Figure 3). At T1, novice users reported higher scores than experts for device visibility under clothing, limitations in clothing choice, leakage, and performing daily activities. Expert users reported higher scores at T1 for items about detachment of the pouch from the body, problems with skin irritation under the appliance, and the ability to maintain normal social relationships.
Discussion
Ostomy surgery can alter patients’ lives in many ways and requires adjustment of daily habits. A patient’s body and self-image may contribute to concerns about intimacy and sexuality. In some cases, the ostomy can change the work and social lives of patients.3-7 Major concerns include the use, fitting, and correct functioning of the ostomy appliance, leading to the need for further improvements and better fit of the appliance to the patient’s lifestyle.14-16 In a recent survey examining the needs of patients with ostomies, with the goal of improving their quality of life through evidence-based practice, pouch leakage and pouch/appliance issues were identified as research priorities.23 Identifying the factors that contribute to poorer QoL in ostomy patients—particularly those related to ostomy device use—is essential to develop effective solutions.
The physical and psychological difficulties associated with the use of ostomy appliances are well known; the need to adjust to the device is one of several challenges reported in a survey of Irish ostomy patients.24 In the present survey, the impact of wearing ostomy appliances on the wellness of ostomy patients in Italy was investigated. To the best of the author’s knowledge, this is the first survey of such a large number of Italian ostomy patients that focused on the impact of an ostomy appliance on aspects of daily life, such as discreetness, comfort, confidence, and social relationships. This survey also took a unique approach in comparing the concerns of novice and expert users of ostomy devices, which has not been previously reported. In the Wellness Questionnaire survey, issues related to discreetness were of lesser concern to novice users, yet these same issues were the major concern for expert users before they changed their device prescription, with worries about device visibility under clothing increasing at 4 weeks after the product replacement. Furthermore, feeling restricted in clothing choices—a concern that diminished as patients became accustomed to the new device—remained the issue that most affected the quality of life of expert users at both wellness evaluation time points. This finding is in line with previous research showing that the inability to conceal the pouch or appliance is one of the most common concerns of patients with ostomies.23-25 Given that expert users were very sensitive to this problem, it should be recognized as a focus of supportive intervention by stoma care personnel.
Regarding comfort, concerns about poor fit of the stoma device to the body were not frequently reported by either novice or expert users. On the other hand, skin irritation problems were a major fear for novice users at both evaluation time points; these concerns significantly improved after 4 weeks of product use, however. Similarly, user experience significantly reduced skin irritation concerns among expert users. While several studies have shown that the severity of skin irritation and rashes predicts the overall QoL of patients with ostomies,7,26-29 the author’s findings indicate that increased experience with the ostomy device may positively influence patients’ overall wellness, which is often affected by the occurrence of peristomal skin complications.
In contrast to comfort in wearing the ostomy appliance, patient confidence in the appliance regarding leakage problems was higher in experts than in novice users. As mentioned earlier, anxiety about pouch loosening or stool leakage is an issue affecting the stoma patients’ life.30 Previous studies on QoL in ostomy patients have most extensively examined concerns about the risk of leakage, with poor wafer adherence cited as one of the most challenging aspects of ostomy management and care.5,7,24,25,27,28 The results of the present wellness survey suggest that not only the initial device prescription but also subsequent product changes can raise concerns about leakage; therefore, this is an issue that may need to be addressed by stoma nurses through specific support and education strategies. To this end, a new measurement tool has recently been developed to evaluate the impact of leakage risk in stoma care and may be useful to both caregivers and researchers.16
Unexpectedly, social life restrictions were among the factors with the least impact on the daily lives of both novice and expert ostomy appliance users, with patients who had recently undergone their first ostomy procedure reporting a slightly worse experience. It has been previously reported that social relationships are among the most important QoL-related issues for patients, mainly because of loss of self-esteem and changes in self-image.3,27,31 The author of the present study found that more experienced users were better able to cope with concerns about their social life, while both novice and expert users reported improvement in individual and overall Wellness Questionnaire scores after 4 weeks of using the new/replaced ostomy device. These results underscore the importance of education and user experience in improving the well-being of ostomy patients.
When caring for ostomy patients, the professionalism, competence, and skills of stoma therapists can help improve the patients’ perception.18 Given the unique challenges of living with ostomy appliances, patients need comprehensive and personalized care to maintain their physical and psychological health.32-34 Specialized ostomy care must be initiated preoperatively and continued throughout the postoperative and rehabilitation phases, as well as throughout the patient’s life. Caregivers and health care professionals should have detailed knowledge of stoma-related problems and their potential impact on patients’ QoL.35 A multicenter, prospective, longitudinal study conducted in Spain18 comparing health-related QoL of ostomy patients assisted by nurses specialized in ostomy care with that of patients not assisted by specialized nurses found that the former adapted better to their stoma and were less concerned about their appearance; were more comfortable cleaning, changing, and disposing of ostomy pouches; and had less pain and lower pain frequency. Moreover, patients cared for by specialized nurses were less anxious and reported improved sleep and better overall health, with a greater percentage of patients leading “normal” lives.
In addition to the need for specialized ostomy care, people living with an ostomy need education and training to manage their ostomy device and to identify and prevent stomal or peristomal complications. Training on ostomy device management can improve quality of care and patient outcomes.36 Home visits by health care professionals to assist with ostomy adjustment can reduce feelings of stigma among patients that limit their social lives. To this end, effective collaboration between ostomy nurse specialists and community nurses is critical.
Limitations
The preliminary raw data from this project show trends but must be interpreted with caution. There were few exclusion criteria limiting the interviews conducted with ostomy patients, so the heterogeneity of the cohort may have caused bias. Patients were included in the survey regardless of the type of stoma appliance used, and this may have had an impact on some specific aspects investigated. However, the large number of patients included is the strongest characteristic of this project and can give a raw picture of the most challenging issues affecting daily life of expert and novice ostomy users. Further studies are planned to confirm the trends observed in the present survey.
Conclusion
The Wellness Questionnaire, carried out by stoma therapists during the clinical follow-up of patients with ostomies, highlighted an overall improving trend 1 month after the device prescription for both expert and novice users. Both types of patients faced daily challenges related to the new ostomy device but from different perspectives. These results suggest that the impact of ostomy surgery on patients’ wellness can be mitigated by experience in the use of ostomy appliances. Issues related to device discreetness and comfort, as well as patients’ confidence and concerns about their social lives, improved after 4 weeks of product use, with more experienced users reporting fewer concerns about pouch concealment, skin irritation, leakage, pouch loosening, and social activities and relationships. These findings can guide stoma nurses in daily patient care by helping to identify the specific needs of patients and their families, limit disease complications, and help patients better manage their devices and cope with the psychological/social impact of living with a stoma. Further studies are needed to confirm the outcomes of this survey.
Acknowledgment
The author thanks the Italian Coloplast Ostomy Forum Group for coordinating the project and drafting the manuscript.
Author Affiliations
Marco Della Valle, RN,1 on Behalf of Ostomy Nurses Involved in the Wellness Project2
1Coloplast Italia, Bologna, Italy
2The Wellness Project involved more than 200 ostomy nurses from outpatient clinics and rehabilitation centers providing care for the largest number of ostomy patients in Italy. The project was coordinated by the Italian Coloplast Ostomy Forum Group, which at an international level has more than 600 ostomy nurses and in Italy is represented by 70 specialists from all national regions. The Coloplast Ostomy Forum Group works within the field of ostomy care to further the well-being of patients with ostomies by promoting surveys aimed at improving clinical practice.
Address for Correspondence
Address all correspondence to: Marco Della Valle, RN, Via Trattati Comunitari Europei, 9 -40127, Bologna; tel: +39-348-131-7794; email: itmdv@coloplast.com
Potential Conflicts of Interest
Marco Della Valle is an employee of Coloplast Italia (Bologna) and played a coordinating role in the nurse group. The ostomy nurses involved in the Wellness Project have no conflict of interest to declare. The Wellness Project was coordinated by the Italian Coloplast Ostomy Forum Group.
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