Advances in medical innovations have resulted in the ability of patients with gastrointestinal disease to manage their care through the broader availability of biological therapies. In fact, reports have demonstrated that care for patients with inflammatory bowel diseases and colorectal cancer have shifted to the use of targeted biological therapies (Kriza et al, 2013; van der Valk et al, 2016). Despite these advances, surgery with the intent to create an abdominal stoma to support the management of benign and malignant gastrointestinal problems is still prevalent globally.
A stoma is an opening on the abdomen that can be connected to either the digestive or urinary system to allow waste (urine or faeces) to be diverted out of the body (Bladder and bowel Community, 2019). Effluent from the stoma is collected by an ostomy pouch that is attached to the skin surrounding the stoma (peristomal skin) by an adhesive barrier. Leakage of effluent to the peristomal skin is a major complication, creating not only a psychological burden concerning 9 out of 10 patients (Claessens et al, 2015), but also a clinical burden that leads to irritation and skin injury (Herlufsen et al, 2006).
Of major concern is the fact that incidence rates of irritated peristomal skin remain upwards of 70% (Salvadalena 2008; Gray et al, 2013; Lindholm et al, 2013; Salvadalena 2013), yet many patients do not seek help because they are unaware that this is a problem (Herlufsen et al, 2006). Left untreated, a mild skin irritation involving only a small portion of the skin can progress and give rise to a severe disorder requiring immediate medical attention (Herlufsen et al, 2006).
Studies have examined the impact of irritated peristomal skin on an individual's quality of life (QoL) using a variety of validated instruments (Pittman et al, 2008; Nichols, 2016; Nichols, 2018). These studies have demonstrated that individuals with severe skin damage report lower QoL than those with a mild skin conditions (Nybaek et al, 2010; Nichols, 2018; Nichols and Inglese, 2018).
The City of Hope and Beckman Research Institute in Duarte, California, developed one such instrument that is specific to understanding the QoL of ostomy patients. This is a disease-specific health survey, focused on the welfare of ostomy patients that allows researchers to compare the QoL impact of one ostomate with another (Maydick, 2016). A different approach would be to use a validated generic survey designed for use across a broad range of diseases and/or populations. The SF-36v2® Health Survey is one such validated tool, which asks 36 questions to measure functional health and wellbeing from the patient's point of view. As a valid measure of physical and mental health, researchers can compare the health status of patients from different disease states or with the general population (Maruish, 2011).
A recent report on the health utility and health-related quality of life (QoL) in adults with a stoma in the USA (Nichols and Inglese, 2018) found that irritated peristomal skin decreases were associated with decreased health utility across all levels of SF36v2 physical component summary scale. In addition, the six-dimensional health state short form (SF-6D) used with people with intact skin and irritation levels representing no physical limitations varied significantly from those with severely compromised skin.
In this article, the analysis was expanded to assess health utility and health-related QoL in a more global population of adults residing in the USA, UK, and Canada. The relationship of four distinct severity levels of peristomal skin complications (normal, mild, moderate, and severe) are evaluated to further describe the clinical and humanistic burden of injured peristomal skin. This study demonstrates that the burden of peristomal skin injury is applicable on a multinational scale. While there may be cultural, political and social differences between countries, the adverse effects of irritated, unhealthy skin are universal. Herein lies an opportunity for clinicians and caregivers to address a critical unmet need in skin health. Done successfully, appropriate clinician and/or caregiver intervention in education, prevention, product use and treatment can improve the patient's health utility, quality of life and quality time in their life.
Study objectives
The purpose of this research was to assess the widespread impact of irritated peristomal skin on the health utility and health-related QoL in an adult multinational ostomy population (aged 18 years and older). Four levels of peristomal skin condition were evaluated: normal, mild, moderate, and severe complications.
Methods
Quality of life instruments
The SF36v2 (Optum Inc) (Optum, 2018), which is a generic health-related QoL survey, was chosen to assess this population. This is a short form health survey that provides an eight domain profile of the health and wellbeing of an adult (aged 18 years and older) target population, and includes psychometric summary measures of physical and mental health. A preference-based health utility index, the SF-6D—which is an instrument contained within the SF36v2—was used to derive health utility values (Brazier et al, 2002).
In conjunction with the SF-6D, the survey included a visual analogue scale of QoL presented as a self-rating scale (scale 0 to 100, where 100 is best possible), and normed to a mean of 50 and a standard deviation of 10, according to methodology described Maruish (2011). This method allows for differences in scores to have a meaningful interpretation when compared with other studies using similar methodology. Mean scores in the range of 45 to 55 are considered representative of the average of the sample. Scores above 55 represent an above-average QoL, scores of between 40 and 45 represent marginal impairments in QoL, and scores below 40 indicate significant impairments or limitations.
Skin irritation assessments
Respondents provided their perception of skin integrity through a self-assessment of their peristomal skin. This assessment was reported through the response to two identical ordinal scale questions: a question of the perception of the usual condition of the respondent's skin and the perception of the skin at the time of the survey. Ranking the cross-tabulated responses allowed for the determination of six categories of skin condition. This was further combined into four main definitions:
- Normal skin: characterised by intact skin with no presence of irritation
- Mild skin irritation: characterised by occasional reddening and irritation caused by stomal discharge or adhesives
- Moderate skin irritation: characterised by always being reddened or irritated by stoma discharge or adhesives, and occasional but slight blistering
- Severe skin irritation: characterised by skin that is always blistered or damaged, where blistering often results in denuded skin caused by the mechanical process of repeated application and removal of an ostomy appliance.
Data collection
The data presented here are the result of random sampling from within proprietary databases in the USA, Canada and the UK, containing email contact information for those that have undergone ostomy surgery. Potential participants (n=16 762) were randomly selected from those who had been entered in the database within 24 months of the start of the study. Of these, 3146 responded and completed the survey, giving a response rate of 18.8% and a margin of error of 1.7%. Independent review board approval (Copernicus Group and Western Institutional Review Board (WIRB)) were obtained for the conduct of the study in the USA and Canada, respectively. In the UK, ethical approval was not required, according to the Health Research Authority, which covers the NHS. The data were collected in Q4 of 2012, through Q4 of 2013.
Statistical analyses
The internal consistency of the data, that is the degree to which items measure the same construct was assessed using Cronbach's alpha (Cronbach, 1951) for each of the domains used to estimate the SF6D health utility measures. Cronbach's alpha gave the following results: physical functioning 0.94; role participation (physical and emotional) 0.94; bodily pain 0.90; social function 0.87; vitality 0.85; and mental health 0.87, therefore indicating the data were reliable. Missing item responses were estimated using the Full Missing Score Estimation method (Maruish, 2011). Data were analysed using SASv9.2.
Estimates of quality-adjusted life days
The analysis evaluates quality-adjusted life days (QALDs), as opposed to the more commonly used quality-adjusted life years (QALYs). Irritated peristomal skin is an intermittent condition appearing and lasting for indefinite periods (usually weeks or months) until a clinical intervention resolves the issues. According to Nichols and Inglese (2018) ‘the usual assessment of quality-adjusted life, in terms of years, is deemed inappropriate to assess the immediate magnitude of the problem’. Given this, days per month is used as the value-weighted time over the relevant time horizon, where a month is defined as 30 days and the QALD is defined as the 30 days multiplied by the health utility value. For readers preferring the more common QALY metric, the health utility values shown in Table 3 (section B) can be considered as QALYs for a duration of one year.
Results
Table 1 and Table 2 present a description of the study respondents by country. Males represent 52.9% of those who participated. They had an average age of 65.2 years ± 12.7 years, and average approximately 11 years from the date of surgery. Females represent the remaining 47.1% of respondents. They had an average age of 61.4 years ± 13.8 years, and average approximately 9 years from the date of surgery. Across all countries, colostomates comprised 40.0% of those in the study, 44.2% are ileostomates, 13.6% are urostomates and 2.2% have multiple stomas or the type of stoma was unknown.
Table 1. Demographics: gender, age, and time from surgery
| Country | Gender | n (%) | Age at time of surgery (years) | Median time from surgery (months) |
|---|---|---|---|---|
| Canadan=312 | MaleFemale | 167 (54.05)142 (45.95) | 62.40 ± 14.3157.25 ± 14.36 | 44.0052.00 |
| UKn=505 | MaleFemale | 250 (49.70)253(50.30) | 67.31 ± 11.8362.33 ± 14.68 | 80.0090.00 |
| USAn=2329 | MaleFemale | 1230 (53.48)1070 (46.52) | 65.12 ± 12.6261.77 ± 13.43 | 44.0043.00 |
Missing data is noted
Table 2. Demographics: country, gender, and ostomy type
| Country | Gender | n (%) | Colostomy (%) | Ileostomy (%) | Urostomy (%) | Multiple stomas or unknown (%) |
|---|---|---|---|---|---|---|
| Canadan=312 | MaleFemale | 167 (54.22)141 (45.78) | 69 (41.32)55 (39.01) | 67 (40.12)77 (54.61) | 29 (17.37)7 (4.96) | 2 (1.20)2 (1.42) |
| UKn=505 | MaleFemale | 244 (49.39)250 (50.61) | 102 (41.80)104 (41.60) | 83 (34.02118 (47.20 | 54 (22.13)26 (10.40) | 5 (2.05)2 (0.80) |
| USAn=2329 | MaleFemale | 1230 (53.48)1070 (46.52) | 467 (38.06)440 (41.43) | 509 (41.48)511 (48.12) | 219 (17.85)85 (8.00) | 32 (2.61)26 (2.45) |
Missing data is noted
To determine the prevalence of the burden of irritated peristomal skin across the different countries, analyses were conducted to establish whether there were statistically significant differences between countries regarding overall QoL, health utility, and QALDs.
Table 3 provides a summary of QoL, health utility and QALD among each country. The adjusted mean QoL scores ranged between 49.21 and 50.61 (Table 3, section A); the non-normed QoL scores were found to be 72.3, 74.4, 75.3 for Canada, UK and the USA, respectively. The adjusted mean health utility value (SF-6D) ranged between 0.691 and 0.705 (Table 3, section B). QALDs are a function of health utility, i.e. the SF-6D health utility value multiplied by the time horizon (30 days). The adjusted mean QALDs ranged from 20.85 days to 21.14 days (Table 3, section C). There were no statistically significant differences between each country with respect to QoL, health utility and QALDs, suggesting that, regardless of country of residence, individuals in this study are experiencing a similar humanistic burden.
Table 3. Quality of Life, health utility (SF-6D), and quality adjusted life day. All scores adjusted for stoma type, gender, age, and time from surgery
| A. Overall quality of life: normed score | ||||
|---|---|---|---|---|
| LS mean | 95% CI | SE | Statistical comparison | |
| Canada (1) | 49.21 | 48.05–50.37 | 0.59 | 1 vs 2: P=0.37131 vs 3: P=0.06152 vs 3: P=0.7739 |
| UK (2) | 50.24 | 49.24–51.23 | 0.51 | |
| USA (3) | 50.61 | 50.12–51.09 | 0.25 | |
| No statistically significant difference is noted | ||||
No statistically significant difference is noted
CI: confidence interval; LS: least square; SE: standard error
Interestingly, there were statistically significant changes when there were perceived changes in skin severity. Tables 4, 5 and 6 demonstrate a linear decrease in QoL, health utility and QALD, respectively, associated with worsening peristomal skin condition overall (P<0.0001) and by country (P<0.0001). The data within the tables was generated using a general linear model adjusted for age and time from surgery. Presented are the mean values and 95% confidence intervals (CI).
Table 4. Skin irritation level by country
| Normed quality of life scores | Total | USA | UK | Canada | ||||
|---|---|---|---|---|---|---|---|---|
| Peristomal skin condition | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI |
| Normal | 52.82 | 52.10–53.53 | 52.95 | 52.11–53.79 | 52.58 | 50.87–54.29 | 52.40 | 50.04–54.75 |
| Mild | 50.67 | 50.12–51.22 | 51.05 | 50.40–51.70 | 50.08 | 48.72–51.44 | 49.18 | 47.54–50.82 |
| Moderate | 46.77 | 45.8–47.69 | 47.06 | 45.98–48.14 | 47.48 | 45.13–49.84 | 43.86 | 41.11–46.60 |
| Severe | 42.96 | 40.94–44.98 | 43.13 | 40.77–45.49 | 42.73 | 37.09–48.36 | 41.84 | 36.26–47.42 |
| Δ normal – severe = | P<0.00019.86 | P<0.00019.82 | P<0.000110.12 | P<0.000110.56 | ||||
CI: confidence interval
A regression model indicates a statistically significant linear decrease in quality of life scores as severity increases, P<0.0001
Table 5. Health utility (SF-6D) values for each level of peristomal skin complications by country
| Qaulity adjusted life days | Total | USA | UK | Canada | ||||
|---|---|---|---|---|---|---|---|---|
| Peristomal skin condition | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI |
| Normal | 0.754 | 0.742–0.766 | 0.758 | 0.745–0.772 | 0.734 | 0.703–0.764 | 0.755 | 0.716–0.794 |
| Mild | 0.697 | 0.688–0.706 | 0.700 | 0.689–0.710 | 0.686 | 0.661–0.711 | 0.698 | 0.671–0.725 |
| Moderate | 0.646 | 0.631–0.661 | 0.650 | 0.633–0.667 | 0.640 | 0.598–0.683 | 0.630 | 0.584–0.676 |
| Severe | 0.602 | 0.570–0.635 | 0.598 | 0.560–0.637 | 0.610 | 0.524–0.696 | 0.629 | 0.535–0.722 |
| Δ normal – severe = | P<0.00010.152 | P<0.00010.160 | P<0.00010.124 | P<0.00010.126 | ||||
Cl: confidence interval
A regression model indicates a statistically significant linear decrease in health utility as severity increases, P<0.0001
Table 6. Quality adjusted life days for each level of peristomal skin complications by country
| Qaulity adjusted life days | Total | USA | UK | Canada | ||||
|---|---|---|---|---|---|---|---|---|
| Peristomal skin condition | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI |
| Normal | 22.62 | 22.27–22.97 | 22.75 | 22.35–23.15 | 22.00 | 21.09–22.92 | 22.65 | 21.49–23.82 |
| Mild | 20.91 | 20.64–21.18 | 20.99 | 20.68–21.30 | 20.58 | 19.84–21.32 | 20.95 | 20.14–21.76 |
| Moderate | 19.38 | 18.93–19.84 | 19.50 | 18.99–20.02 | 19.21 | 17.94–20.48 | 18.90 | 17.51–20.29 |
| Severe | 18.06 | 17.09–19.04 | 17.95 | 16.81–19.10 | 18.30 | 15.72–20.88 | 18.86 | 16.05–21.68 |
| Δ normal – severe = | P<0.00014.56 | P<0.00014.80 | P<0.00013.70 | P<0.00013.79 | ||||
Cl: confidence interval
A regression model indicates a statistically significant linear decrease in quality adjusted life days as severity increases, P<0.0001
Regression models were applied to determine the significance of the associations between QoL and perceived skin irritation severity. Table 4 presents the QoL data for each skin irritation level by country, adjusted for age and time from surgery. As individuals perceive an improvement in peristomal skin condition, the QoL rating also improves (and vice versa). The mean overall QoL difference, all countries, between normal (intact) peristomal skin and severely irritated peristomal skin was found to be 9.86. The mean overall QoL difference between normal (intact) peristomal skin and severely irritated peristomal skin for the USA was found to be 9.82; the UK 10.12 and for Canada 10.56. These differences suggest incremental declines to QoL as peristomal skin condition worsens.
Table 5 presents the SF-6D health utility values for each level of peristomal skin complications by country. The data are adjusted for age and time from surgery. As peristomal skin condition improves there is an overall associated improvement in health utility (and vice versa). The mean overall health utility difference for all countries, between normal (intact) peristomal skin and severely irritated peristomal skin, was found to be 0.152. Health utility scores are valuable inputs because they can be translated to QALDs.
Table 6 presents the QALDs for each level of peristomal skin complications by country. The data are adjusted for age and time from surgery and are an arithmetic function of the data in Table 5. Table 6 demonstrates a positive relationship with peristomal skin condition improvement and associated increase in QALDs (and vice versa). The mean overall QALD difference for all countries between normal (intact) peristomal skin and severely irritated peristomal skin was found to be 4.56 days. The mean overall health utility difference between normal (intact) peristomal skin and severely irritated peristomal skin was found to be 4.80 days for the USS, 3.70 days for the UK and 3.79 days for Canada. These data suggest that, overall, individuals are losing quality days as they experience worsening peristomal skin irritation.
Although the data indicates overall decreases in quality of life, health utility and QALDs associated with worsening peristomal skin, country-specific comparisons between adjacent peristomal skin levels are not necessarily statistically different, as evidenced from the overlapping confidence intervals (Table 6). Although individuals in this study experienced a similar humanistic burden, regardless of country of origin, they were also all experiencing statistically significant declines in their QoL, health utility and QALDs when they perceived changes from normal skin (intact) to severely irritated skin.
Discussion
Peristomal skin complications remain one of the most prevalent ostomy-related problems, with a reported high incidence of between 40% and 77% (Herlufsen et al, 2006; Richbourg et al, 2007; Gray et al, 2013; Salvadalena, 2013). The impact of peristomal skin complications are more than a dermatological issue—damaged skin can affect an individual's health status and QoL extensively. This study presents a three-country investigation into the QoL, health utility and QALDs of people who had undergone ostomy surgery.
While the results indicate that there are no statistically significant differences for these aspects between countries, when the respondents perceived a decline in their peristomal skin condition, this was linked to incremental declines in all three attributes investigated. Table 5 provides the health utilities' values and their changes with increasing severity of skin irritation. Overall, for all countries, individuals reported a mean health utility score of 0.754 (95% CI: 0.742–0.766) when they perceived normal, intact skin, and 0.602 (95% CI: 0.57–0.635) when they perceived severely irritated skin. This provides a mean overall difference of 0.152. Given that a minimally important difference in scale for the SF-6D health utility instrument has been reported to be 0.041 (Walters and Brazier, 2005), improving peristomal skin condition is accordingly associated with significant increases in health utility.
The practical significance of this is when health utility values are translated into QALDs. For our purposes, the QALD metric is the number of quality days that the individual has in a month (30 days). A health utility value of 1 indicates that the individual experiences 30 quality days in a 30-day period. If an individual has a utility value of 0.5, then the quality days are adjusted to 15 days out of 30.
In this study, individuals with normal (intact) peristomal skin have on average 22.62 QALDs per month. However, individuals lose 4.56 QALDs when they experience severe peristomal skin irritation (individuals with severe peristomal skin irritation have an average of 18.06 QALDs per month). As a metric of comparison, Maruish (2011) found that the average SF-6D health utility value for the US general population was 0.74, translating to 22.22 QALDs per month. Thus, while ostomates with normal (intact) peristomal skin have health utility comparable with a general population, that is no longer the case when the severity of peristomal skin irritation increases and health utility values decline, thereby diminishing their QALDs.
The notion that the severity of peristomal skin irritation is associated with an individual's humanistic burden presents an important issue that clinicians and caregivers from around the world must help patients address. The negative effects of poor skin health are universal. Left untreated, poor peristomal skin health will continue to plague a person's ability to live a satisfied and quality life. Clinicians, caregivers and patients themselves have the responsibility for ensuring that they incorporate methods that maintain intact healthy skin and thus maximise opportunities for optimal health status and quality days.
Limitations
The data reported here are derived from a cross-sectional survey. Given that respondents provided their perception of skin integrity through a self-assessment of their peristomal skin, associations to health-related QoL measures are based on perceptions of skin irritation levels. Moreover, although the associations found between peristomal skin health and quality of life, health utility and quality adjusted life days are strongly suggestive of the overall benefit that a successful skin care intervention can have, the cause and effect cannot be determined.
Conclusion
Successful treatment intervention in peristomal skin health, or skin health in general, can have a positive impact on the individual, and in the collective provide an overall societal benefit. The data indicate that successful treatment of a peristomal skin problem can have a positive impact on health-related QoL as a function of quality of life, health utility and regaining quality time in the patient's life. The data support the premise that, as skin conditions improve, increases in health utility, quality-adjusted lifetimes and associated QoL are seen as well. The authors recognise that successful treatment from a clinical perspective has a much broader reach, that is, it is also the giving back to the individual quality time in their life.
KEY POINTS
- Irritation and injury to peristomal skin is more than just a dermatological issue as it has far-reaching effects on an individual's health utility and quality of life
- This article aimed to assess the impact of damage peristomal skin on health utility and quality-adjusted life days on patients in three countries
- Irritations to peristomal skin is a universal issue affecting individuals with stomas around the world
- By addressing skin health, clinicians and caregivers have an opportunity to give back quality days to an individual's life
CPD reflective questions
- How do you engage with your patients to assure that clinical improvements are translated to improved quality of life?
- When you engage with other clinicians from other countries, do you find that the impact, prevalence or severity of irritated peristomal skin varies from one country to another?
- What types of interventions have you used that have prevented and improved your patients' skin health?