Methods and Initial Findings of the Observational Study of Ostomy Consumers Registry

Having an ostomy is relatively uncommon, although rates vary by country. In the United States (US), an estimated 725,000 to 1 million individuals live with an ostomy,¹ whereas around 13,000 stoma surgeries are estimated to occur each year in both Canada and the United Kingdom (UK).^2,3 However, because stomas that are initially intended as temporary are often not reversed,^4,5 more precise estimates of prevalence are not available.Preoperative and postoperative ostomy care and education help reduce complications and enable patients to adjust to living with a stoma, yet such support is inconsistently provided.^6-9 In a descriptive, quantitative survey of 325 individuals living with an ostomy, Miller et al reported that 40% of patients failed to learn some basic skills of ostomy care before hospital discharge.⁶ Richbourg et al reported that most of the 34 individuals in a cross-sectional survey experienced difficulty with their ostomy and had a high incidence of skin irritation (76%), pouch leakage (62%), and such problems as odor (59%) and depression (53%); 20% of respondents did not seek help for these concerns.⁷ Using a phenomenological method with 12 participants, Cengiz and Bahar identified the need for more frequent visits from health care providers with knowledge of ostomy care.⁸ In an editorial, Dale et al discussed the negative effect of this learning gap on the support needed by individuals with a stoma and appealed to home health practitioners to seek additional resources to fill this need.⁹

The mismatch between patient needs and available ostomy care and follow-up can negatively influence patients’ adjustment to the physical, psychological, and/or social effects of living with a stoma.^10,11 Peristomal skin complications are common and persistent, and their occurrence is associated with reduced quality of life and increased health care costs.^12,13 In a retrospective cohort study of 128 patients, Taneja et al found an association between peristomal skin complications, hospital length of stay, and costs of postsurgical care.¹³ The study was replicated 2 years later, using records of 168 patients.¹² In the subsequent study, one-third of patients developed peristomal skin complications within 90 days after surgery, which were associated with increased cost and likelihood of hospital readmission.

Ratliff et al conducted a scoping review of the literature related to peristomal skin health and reported the recommendations and conclusions of a consensus conference involving 15 US experts.¹⁴ They identified research gaps in the areas of pouching care and pouch systems and how these factors affect skin health. Such research gaps can be filled in part through longitudinal data. In a prospective, repeated-measures study, Pearson et al found that a high proportion of the 435 stoma patients who were evaluated by stoma care nurses over a 2-year period experienced leakage, nighttime soiling, and stoma complications (eg, skin complications, hernias), which often worsened over time.¹⁵

Physical complications of a stoma are associated with reduced quality of life. Nichols reported results of a cross-sectional health-related quality of life survey in 2329 community-dwelling respondents with an ostomy, referencing the results against the general US population.¹⁰ The physical component scores of quality of life were lower in the stoma group than in the reference population. In a secondary analysis of data from 239 individuals in a descriptive case control study, Pittman et al found that patients with severe complications (eg, skin problems, pouch leakage, difficulty adjusting) had significantly poorer quality of life than those with mild complications.¹¹ Longitudinal patient-reported data are limited, but long-term access to individuals with an ostomy can provide detailed information about their ongoing experience, elucidating the extent, progression, management, and impact of complications. Creative strategies are therefore needed to reach patients who have infrequent contact with ostomy nurses to learn more about their unique experiences with stoma management and the impact on their lives.

Registries are organized systems for the collection of observational data. Clinical registries can serve many purposes, such as describing the course of diseases or conditions and measuring quality of care and the effectiveness of health care products and services.¹⁶ Registries are often used by the Centers for Medicare and Medicaid Services to reflect the quality of care in participating institutions. A review by Blumenthal summarized the value of registries to health care and provided a framework to guide registry development.¹⁷ Some disease-specific databases, such as colorectal cancer registries, include stoma-specific information that could be used to compare outcomes in patients with a stoma versus those without.¹⁸ Verweij et al used the Eindhoven Cancer Registry to survey quality of life for 494 individuals with a stoma and compared the results to a normative population.¹⁸ Registry data have also been mined for large cohort studies to report long-term outcomes following surgical procedures involving stomas¹⁹ and to develop a predictive model of stoma complications.²⁰ Holmgren et al conducted a retrospective cohort study to validate the quality of registry information about the presence or absence of a permanent stoma for 312 patients and found few discrepancies.¹⁹ Ocagli et al established a new registry and developed an algorithm for ostomy care using data from the first 52 participants.²⁰ A regional database in Denmark contains information on peristomal skin complications for 1123 patients entered by stoma care clinicians at multiple collaborating medical centers. Danielsen et al described the methods of developing that database as a resource for future research.²¹ Fleshman and Lewis reported results from 1 US ostomy registry of over 16,000 participants, describing demographics, stoma types, self-reported complications, and quality of life for a cohort of over 16,000 individuals.²² Importantly, within currently existing registries, data about the specifics of ostomy product (eg, manufacturer, type, stock number) are rarely captured, precluding cost-analysis.

There are advantages to establishing a registry for use in clinical research of the longer-term experiences and perceptions of individuals with an ostomy. Registries generally have broad inclusion criteria, providing opportunities for participation from individuals who may not qualify for clinical trials, thus more closely approximating real-world experience. Patient-related factors, such as convenience, trust, and interest in sharing experiences, are thought to positively influence willingness to participate in a registry and may boost enrollment and retention. Lee et al reported on focus groups held with 23 individuals to explore their perspectives related to registry participation.²³ Several themes identified were related to the perceived benefits of registries, such as altruism, connecting with others, enriched understanding of their condition, and the ability to explain the many factors that affected them between health care visits. Certain types of registries permit data to be reported by the participant rather than by a health care provider; this is 1 method of enhancing participant engagement and patient-centric focus.²⁴ The ability for patients to complete surveys on their own allows for data to be reported without mediation or re-interpretation by a health care practitioner or study investigator. Reliable, validated surveys can be combined with questionnaires targeted toward exploring specific stoma-related issues and executed via a variety of methods (eg, paper survey, electronic questionnaire, participant diary). A patient registry in which respondents self-report data on a repeated basis is therefore a way to successfully collect longitudinal data about ostomy consumer experiences and perceived unmet needs.

The purpose of this paper is to describe the establishment of the Observational Study of Ostomy Consumers (OSO) registry and the baseline profile of registry participants enrolled as of February 2021. The overall goal of the OSO registry is to establish and maintain a dynamic source of self-reported data that can provide a resource for better understanding aspects of life with an ostomy.

Study design and setting. The OSO registry was developed to prospectively collect observational, patient-reported outcomes (PRO) data over 5 years, using repeated-measures collection methods. Data are collected electronically; no in-person visits are conducted that are directly related to the registry. The registry was established in October 2018 and, as of February 2021, continues to enroll new participants and to conduct monthly surveys, which are sent to the retained participants.

Eligibility criteria. The registry enrolled adults (≥ 18 years) with a fecal or urinary intestinal stoma, or their lay caregivers. Participants were eligible to enroll if they were willing and able to complete online questionnaires or had a proxy who could enter data on their behalf. Patients were not included or excluded according to the time elapsed since surgery or the ostomy product manufacturer, but individuals with more than 1 stoma or a reversed and/or closed stoma were not eligible.

Participants could choose to withdraw from the study at any time. They were discontinued by the sponsor if they were lost to follow-up (ie, if they initially provided some amount of self-reported data but failed to respond to follow-up contact efforts). In addition, participants who no longer met eligibility criteria were discontinued. Otherwise, participants could continue to participate even if they missed multiple monthly surveys but contributed data at a later time.

Recruitment and enrollment. Participants were recruited from the sponsor’s proprietary database of ostomy consumers. In addition, ostomy nurses were provided approved recruitment handouts at ostomy specialty conferences. Initial and ongoing review and approval were obtained for clinical study documents through the WCG IRB Institutional Review Board (Puyallup, WA). Participants were informed that they had the right to withdraw from the registry at any time without penalty. The OSO registry is posted on clinicaltrials.gov (NCT03715179) as the Observational Study of Ostomy Consumers.

Study size. Planned enrollment in the registry was based on a convenience sample, rather than a statistical rationale. Instead, a sample size of approximately 600 participants was established as a feasible expectation in this research context. Enrollment is ongoing; the results from participants enrolled between October 2018 and February 2021 are reported in this paper.

Instruments and study variables. Quality of life (QOL) was assessed using the Stoma-QOL questionnaire, which consisted of 20 items pertaining to ostomy-related concerns, self-image, self-esteem, sleep and fatigue, and personal relationships.^25,26 The Stoma-QOL was validated by Prieto et al using the Rasch model and a sample size of 182 individuals.²⁵ Cronbach’s alpha was 0.92, and test reliability was > 0.88 (P = .01). In a study of 120 patients, Lai et al reported a reliability of 0.93 for the questionnaire.²⁶ Each item on the instrument was scored from 1 (always) to 4 (never). The total score ranged from 20 to 80, with the highest number considered most positive. Additional questions, created specifically for the registry, covered content about ostomy product use (ie, brand of ostomy product, use of convexity, barrier type, product from prior surgery), habits (ie, use of ostomy accessories, application), and product satisfaction (ie, ease of application, time to change, ease of removal, secureness of fit), as well as stomal characteristics (ie, location of stoma [stoma in skin fold or abdominal crease], shape of stoma), peristomal skin health (ie, skin condition, leakage, frequency and severity), health care utilization (ie, hospitalizations, outpatient visits for an ostomy-related issue), ostomy surgery (ie, time or duration with stoma), reason for ostomy, and participant demographics (ie, height, weight, body mass index, income, education level). In total, the registry included 10 questionnaires. The monthly time required to complete all surveys was estimated to be approximately 30 minutes or less.

Data collection. Participants completed questionnaires once per month for the first year of their participation and then quarterly for up to another 4 years. All electronic PRO data were collected via electronic clinical report forms in a secure, cloud-based electronic PRO environment. Participant consent and eligibility screening were conducted online via a consent form and screening questionnaire. Participants were sent email reminders when new questionnaires were available for completion. All participants were provided a 7-day window in which to complete each monthly set of questionnaires. The longitudinal design of the registry allowed participants to miss 1 or more registry visit and return later to complete subsequent visits.

Data analysis. Registry data were retrieved from the Medrio electronic data capture system, uploaded to Azure Databricks for transformation and creation of calculated variables, then aggregated and visualized using Microsoft Power Query and Power BI software. The primary purpose of the analysis covered in this report was to describe the data variables specific to the demographics, stoma characteristics, product type, wear time, and product satisfaction of the enrolled US and UK participants at baseline, when the first survey forms were completed. Other data variables reported in this paper were the Stoma-QOL scores, frequency of leakage, and itching experienced by participants at baseline. These data were summarized using descriptive statistics.

Baseline data were received for 299 participants in the OSO registry from both the US (n = 233 [77.9%]) and UK (n = 66 [22.1%]). The US had a response rate of 11.6% (304 enrollments from 2619 emailed recruitment letters), and the UK response rate was 8% (220 enrollments from 2659 emailed recruitment letters). Of the 299 participants ever enrolled, 267 (89%) were retained and 32 (11%) left the study, either due to ostomy reversal surgery/ineligibility or due to participant withdrawal.

Participant demographics are shown in Table 1, Part 1 and Table 1, Part 2. Specific stoma characteristics of the participants are shown in Table 2, Part 1 and Table 2, Part 2. As shown in Table 1, there were 291 participants who responded to the height and weight questions, and calculations of body mass index using these data indicated that about one-third of participants (n = 97 [32.8%]) were categorized as obese, one-third (n = 92 [31.1%]) as overweight, and nearly one-third (n = 91 [30.7%]) as normal weight. Only 11 (3.7%) participants were calculated to be underweight. Most participants (n = 166 [55.5%]) reported using a two-piece pouching system rather than a one-piece system (n = 133 [44.4%]). Nearly all reported using either a convex barrier (n = 162 [54.4%]) or flat barrier (n = 133 [44.3%]); the remaining participants reported using another barrier type (n = 3 [1.0%]) or that they did not know the barrier type (n = 1 [0.3%]). Participants reported using pouching systems manufactured by Hollister, Coloplast, Convatec, Dansac, and other manufacturers. Overall, the most commonly reported barrier wear time was at least 3 days but less than 4 days for 92 (30.9%) participants. This was also the most common wear time among the US participants (n = 85 [36.6%]); in the UK, most respondents reported a wear time of at least 1 day but less than 2 days (n = 28 [42.4%]).

All 299 participants provided responses related to product satisfaction, and 288 participants provided responses to the Stoma-QOL questionnaire. Raw scores for the Stoma-QOL ranged from the minimum possible score of 20 to the maximum possible score of 80, with a median score of 58 (Table 3). Participants reported being generally satisfied with their ostomy products; a majority of the 299 participants (n = 275 [92.0%]) indicated that they were very satisfied or somewhat satisfied with their current ostomy pouching system.

Table 4, Part 1 and Table 4, Part 2 present the distribution of the frequency of leakage in the last month, examined relative to several factors of interest. Table 5, Part 1 and Table 5 Part 2 present frequency of itching in the last month in a similar manner.

Understanding the demographics, ostomy characteristics, and product use of the OSO registry participants provides insights into the experience and quality of life related to living with an ostomy. Despite a lack of robust evidence for a selection of convex products,²⁷ a small study conducted in Sweden reported that 12% to 28% of fecal ostomates use convex barriers.²⁸ This difference might reflect changes in convexity use over time or simply country-specific variation. Further exploration is warranted given that 57.2% of respondents in the OSO registry reported leakage, and no gross differences were found in leakage frequency between users of flat barriers versus convex barriers. Likewise, as enrollment increases, the investigators will be able to report on longitudinal changes in the characteristics and brands of product used.

In describing the health of their peristomal skin, 41% of participants reported clear skin (no redness or other problems). However, a majority (58.9%) reported alterations in the peristomal skin that included redness alone (40.1%), redness with a rash (10.4%), or open sores (8.4%). These findings are consistent with reports that peristomal complications are common.^12,29,30 Others have noted that patients do not recognize and report their own peristomal skin problems.^31,32 The OSO registry provides an opportunity for future exploration of factors associated with changes in skin over time.

Pruritus is associated with such peristomal skin conditions as dermatitis and peristomal epithelial hyperplasia.³³ However, to the authors’ knowledge, this is the first prospective study to provide data on the prevalence of itching among people living with a stoma. The baseline results suggest itching is common but varies in frequency and perceived importance to the individual. Longitudinal data about changes in itching, as well as correlational analyses, may inform about ways to improve the patient experience and quality of life.

With regard to leakage, each participant was asked, “In the last month (30 days) have you had any leaks from under your skin barrier?” Those who answered “yes” then responded to questions about leakage frequency. Of the 299 participants, 111 (37.1%) reported experiencing leakage at least once within the last month, and 60 (20.1%) said leakage occurred at least once per week. As more data are collected and longitudinal changes are identified, variables may be identified that influence leakage frequency.

Looking forward, it may be helpful to further understand how participants define a leak. Likewise, it would be helpful to know whether participants are reporting leakages that are confined to the barrier or that extend beyond the barrier, or by sensation of itching or burning.

The quality of life reported by these participants is favorable. Baseline quality of life, measured using the Stoma-QOL tool, is similar to the median score of 61 reported by Canova et al in a study of 251 Italian patients with ileostomy and colostomy.³⁴ Scores were comparable to those in a small study by Silva et al³⁵ and slightly higher than those in a Canadian study of 120 individuals scheduled for stoma reversal.²⁶ The differences between the scores may be clinically insignificant and reflective of study-specific demographics (eg, different countries, different stoma types and stoma duration). Further analyses of changes in individual score over time will be helpful.

The OSO registry provides a way to collect longitudinal information directly from patients about their experiences living with an ostomy. The inclusion criteria are broad and more closely reflect the population of individuals with a stoma than the population of participants in a clinical study. At this point in time, however, the results consist of survey data from only 2 countries, and the sample size is too small for correlational analyses. Future results may change as the number of individuals and countries participating in the registry increase, and according to variations in the health care delivery systems in each country. Participants were recruited from contacts in the sponsor’s proprietary database and may not be representative of the total population with ostomies, thus a selection bias may be present and correlational analyses might be misleading. As an observational study, there is no control group or normative population.

Self-reported data provides the voice of the participant, but this comes with limitations as well. Self-reported data about peristomal skin condition has been shown to have poor agreement with clinician assessment,^31,32 thus caution is warranted when comparing these results with the results of studies that collect data directly from clinical records.

Despite its limitations, the OSO registry is unique in that it collects information directly from the individual living with an ostomy. Self-reported data are a strength in a registry because they provide an account given from each person as they are living with an ostomy. It is important to hear from the participants how they are dealing with different experiences while adjusting to life with a stoma.

The most direct method for learning about the challenges of living with an ostomy is to ask individuals with a stoma about their experiences over time. Individuals can describe their experiences, and this in turn can help others in discovering methods to facilitate adaptation to their new routines. Despite the reports of leakage and peristomal skin conditions, quality of life for the overall population remained favorable and similar to that reported in previous studies. A majority of participants responded that they were very satisfied or somewhat satisfied with their ostomy product.

The OSO registry is a prospective, ongoing collection of self-reported data from individuals living with an ostomy in the US and UK. The OSO registry purposely includes individuals with the 3 types of ostomies using all manufacturers’ products. In setting up the registry in this manner, it allows for a greater understanding of the ostomy population across the 3 types of stomas using different manufactured products. The benefits of expanding the OSO registry to the full planned enrollment (N = 600), including the addition of Canadian participants, is expected to provide further insights into ostomy clinical practice and education and ostomy management, potentially inform product innovations, and direct future research and health care resource utilization.

The authors thank each participant of the ongoing ostomy registry for their contributions.

Ms Malandrino is a principal clinical scientist, Global Clinical Affairs, Hollister Incorporated, Libertyville, IL. Ms Goldberg is a wound and ostomy specialist, Delray Wound Treatment Center, Delray Beach, FL. Mr Riemer is a principal data scientist, Dr Salvadalena is a fellow, and Ms Urwin is a clinical data management specialist, Global Clinical Affairs, Hollister Incorporated, Libertyville, IL.

Ms Malandrino, Mr Riemer, and Ms Urwin are employees and hold stock in Hollister Incorporated. Dr Salvadalena is a former employee of Hollister Incorporated.

Address all correspondence to: Renee Malandrino, MSN, RN, CWOCN, Hollister Incorporated, 2000 Hollister Drive, Libertyville, IL 60048; tel: 224-358;9817; email: Renee.Malandrino@hollister.com.

Some of the content included in this manuscript was presented orally at the 2021 Nurses Specialized in Wound, Ostomy and Continence Canada National Conference and in poster format at the WOCNext 2021 Conference.