Methods and initial findings of the Observational Study of Ostomy Consumers Registry.

BACKGROUND: Longitudinal patient-reported data are limited for people living with an ostomy. PURPOSE: The Observational Study of Ostomy Consumers (OSO) registry collects data from individuals living with an ostomy. METHODS: Self-reported data were collected via repeated electronic surveys completed by adults living with an ostomy in the United States (US) and United Kingdom (UK). RESULTS: Baseline data, collected between October 2018 and February 2021, were available for 299 individuals from the US (77.9%) and UK (22.1%). Most participants reported using a 2-piece pouching system (55.5%) rather than a 1-piece system (44.4%), and using a convex barrier (54.4%) or flat barrier (44.3%). The most commonly reported barrier wear times were ≥ 3 to < 4 days for 36.6% of participants in the US and ≥ 1 to < 2 days for 42.4% of participants in the UK. Despite self-reports of leakage and peristomal skin conditions, quality of life remained positive. A majority of participants (92.0%) reported being very satisfied or somewhat satisfied with their ostomy product. CONCLUSION: The Observational Study of Ostomy Consumers registry allows for a continuous data stream that can be mined to help understand the patient experience over time. Understanding patient experiences will help to inform clinical practice and research, health care utilization, and product innovation.

Lessons Learned About Peristomal Skin Complications: Secondary Analysis of the ADVOCATE Trial.

PURPOSE: The aims of this study were to (1) describe the demographic and clinical characteristics of the individuals with peristomal skin complications (PSCs); (2) describe the PSCs; (3) examine the relationship of PSC occurrence and severity with possible risk factors, and (4) describe how PSCs were managed clinically. DESIGN: Secondary analysis of data from randomized controlled study, the ADVOCATE trial. SUBJECTS AND SETTING: Study participants (n = 153) were divided into 2 groups: those who did not experience a PSC (n = 80) and those who did (n = 73). A participant was considered to have sustained a PSC during the original study if his or her Discoloration, Erosion, and Tissue score increased above the baseline score. METHODS: Demographic and pertinent characteristics of participants with and without PSCs were compared. In addition, data from the 73 participants who sustained PSCs were further analyzed to characterize and describe the PSCs, to investigate potential risk factors associated with the occurrence and severity of a PSC, and for clinical management. Group comparisons were made via t tests for continuous variables, χ test or Fisher exact test for categorical variables, and generalized linear models for identification of risk factors. RESULTS: The majority of the PSCs were mild or moderate in nature, and they were most commonly categorized by the investigators as irritant dermatitis. Two risk factors were associated with an increased likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases. Within the study period, the odds of sustaining a PSC increased over time and the presence of skinfolds or creases increased the likelihood of PSCs. Peristomal skin complication severity was likely to be worse with an ileostomy and less severe as stoma duration increased. Products used to manage PSCs consisted of barrier rings/seals, skin barrier powder, and paste or paste strips. CONCLUSIONS: Ileostomy is associated with higher risk of a severe PSC and peristomal skin creases or folds. Patient follow-up should be on a structured schedule beyond the first few weeks after surgery because the likelihood of getting a PSC increases over time. This approach may help improve outcomes, particularly for those with an ileostomy and challenging skin contours.

Peristomal Medical Adhesive-Related Skin Injury: Results of an International Consensus Meeting.

Stomal and peristomal skin complications (PSCs) are prevalent in persons living with an ostomy; more than 80% of individuals with an ostomy will experience a stomal or peristomal complication within 2 years of ostomy surgery. Peristomal skin problems are especially prevalent, and a growing body of evidence indicates that they are associated with clinically relevant impairments in physical function, multiple components of health-related quality of life, and higher costs. Several mechanisms are strongly linked to PSCs including medical adhesive-related skin injuries (MARSIs). Peristomal MARSIs are defined as erythema, epidermal stripping or skin tears, erosion, bulla, or vesicle observed after removal of an adhesive ostomy pouching system. A working group of 3 clinicians with knowledge of peristomal skin health completed a scoping review that revealed a significant paucity of evidence regarding the epidemiology and management of peristomal MARSIs. As a result, an international panel of experts in ostomy care and peristomal MARSIs was convened that used a formal process to generate consensus-based statements providing guidance concerning the assessment, prevention, and treatment of peristomal MARSIs. This article summarizes the results of the scoping review and the 21 consensus-based statements used to guide assessment, prevention, and treatment of peristomal MARSIs, along with recommendations for research priorities.

Measuring epidermal effects of ostomy skin barriers.

BACKGROUND: Ostomy barriers are adhesive devices designed to hold pouching systems to the abdomen and protect the peristomal skin from stoma effluent. The objective of this study was to determine differences in the extent of skin trauma resulting from serially applying and removing two types of ostomy barriers. METHODS: The study was a randomized, prospective, repeated measure trial involving healthy volunteers. The ostomy skin barriers were applied to the abdomen and changed every 3-4 days over a 17-day period. Skin observations (erythema, stripping, edge irritation and overall comparisons) were completed by a trained (blinded) observer. Transepidermal water loss (TEWL) measurements were completed by a separate (blinded) technician. TEWL was measured in a designated site and again in the most visually traumatized location at termination. RESULTS: Statistically significant differences were found between the two test devices in all assessments but visual observation of erythema. Highly significant differences in TEWL were found between the test products when measured at termination from the most visually traumatized sites. CONCLUSIONS: The ostomy barrier with ceramide was significantly less disruptive to the epidermis than the ostomy barrier without ceramide. TEWL measurements were more sensitive to changes in the barrier function of the skin than visual observation of erythema.

A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

PURPOSE: To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. DESIGN: The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. SUBJECTS AND SETTING: The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. METHODS: Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. RESULTS: Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: -1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were "very satisfied" with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was noted in both groups. CONCLUSIONS: The use of a ceramide-infused barrier significantly decreased cost and increased satisfaction with patient-reported outcomes.

Use of Convexity in Ostomy Care: Results of an International Consensus Meeting.

Ostomy skin barriers that incorporate a convexity feature have been available in the marketplace for decades, but limited resources are available to guide clinicians in selection and use of convex products. Given the widespread use of convexity, and the need to provide practical guidelines for appropriate use of pouching systems with convex features, an international consensus panel was convened to provide consensus-based guidance for this aspect of ostomy practice. Panelists were provided with a summary of relevant literature in advance of the meeting; these articles were used to generate and reach consensus on 26 statements during a 1-day meeting. Consensus was achieved when 80% of panelists agreed on a statement using an anonymous electronic response system. The 26 statements provide guidance for convex product characteristics, patient assessment, convexity use, and outcomes.

WOCN Society and AUA Position Statement on Preoperative Stoma Site Marking for Patients Undergoing Urostomy Surgery.

Marking the optimal location for a stoma preoperatively enhances the likelihood of a patient's independence in stoma care, predictable pouching system wear times, and resumption of normal activities. Urologists and certified ostomy nurses are the optimal clinicians to select and mark stoma sites, as this skill is a part of their education, practice, and training. However, these providers are not always available, particularly in emergency situations. The purpose of this position statement, developed by the Wound, Ostomy and Continence Nurses Society in collaboration with the American Urological Association and the American Society of Colon and Rectal Surgeons, is to provide a guideline to assist clinicians (especially those who are not surgeons or WOC nurses) in selecting an effective stoma site.

WOCN Society and ASCRS Position Statement on Preoperative Stoma Site Marking for Patients Undergoing Colostomy or Ileostomy Surgery.

Marking the optimal location for a stoma preoperatively enhances the likelihood of a patient's independence in stoma care, predictable pouching system wear times, and resumption of normal activities. Colon and rectal surgeons and certified ostomy nurses are the optimal clinicians to select and mark stoma sites, as this skill is a part of their education, practice, and training. However, these providers are not always available, particularly in emergency situations. The purpose of this position statement, developed by the Wound, Ostomy and Continence Nurses Society in collaboration with the American Society of Colon and Rectal Surgeons and the American Urological Association, is to provide a guideline to assist clinicians (especially those who are not surgeons or WOC nurses) in selecting an effective stoma site.

The incidence of stoma and peristomal complications during the first 3 months after ostomy creation.

PURPOSE: The purpose of this study was to examine stoma and peristomal complications and related variables among adults with ostomies. The primary study aim was to determine the incidence of peristomal and stoma complications during the first 3 months after stoma creation. DESIGN: Data were collected using a prospective, repeated-measures descriptive study design. SUBJECTS AND SETTING: Data were collected at 2 university-based hospitals with outpatient ostomy clinics in the Midwestern United States. The sample included 43 adults with newly created colostomy, ileostomy, or urostomy stomas. METHODS: Participants were examined for the presence of complications up to 4 times during a 3-month period: within 7 days of surgery. Patients were also evaluated at 2, 6, and 12 weeks after stoma creation. Data were collected using a validated instrument with acceptable interrater reliability. RESULTS: Peristomal skin complications developed in 27 participants, comprising 63% of the sample. The onset of peristomal skin complications occurred most frequently during the 21- to 40-day time period. The most common skin conditions at nearly all time intervals were irritation (peristomal moisture-associated skin damage) and infection. Of the 18 participants observed 70 days or longer, just 7 (38%) remained free of peristomal skin complications throughout the study. Six participants developed 1 or more stoma complications, all of which occurred 20 or more days after surgery. No demographic or clinical factors were found to be associated with the development of complications. CONCLUSIONS: Although the participants were evaluated at regular intervals by a specialized nurse, the majority experienced peristomal skin complications. These results underscore the importance of further work in interventions to prevent and treat peristomal skin complications and to provide ongoing outpatient follow-up to individuals with stomas.

Procedure for obtaining a urine sample from a urostomy, ileal conduit, and colon conduit: a best practice guideline for clinicians.

The purpose of this document was to define the correct technique for obtaining a urine sample from a urostomy, ileal, or colon conduit. While healthcare providers do not commonly encounter patients with a urostomy, knowledge of the correct procedure to obtain a urine specimen is essential. Urine samples obtained incorrectly from a urostomy can lead to inaccurate cultures, resulting in an improper diagnosis and treatment, which can endanger the life of a patient. This column presents patient preparation, the procedure to obtain a specimen with and without a catheter, and aftercare of the patient and specimen. This best practice guideline has been developed by a panel of certified ostomy nurses serving on the Wound, Ostomy and Continence Nurses (WOCN) Society's Clinical Practice Ostomy Committee. The guideline has undergone content validation through a consensus-building process by the WOCN Society, which was managed by the Center for Clinical Investigation.

Incidence of complications of the stoma and peristomal skin among individuals with colostomy, ileostomy, and urostomy: a systematic review.

The objectives of this systematic review were to assess the incidence of complications of the stoma and peristomal skin, synthesize possible reasons for variability in results, and make recommendations for future research. Twenty-one studies published in English between January 1990 and August 2007, with a prospective design that reported the number of complications of the stoma or peristomal skin among participants with colostomy, ileostomy, or urostomy, were identified. The types of complications most commonly reported were retraction, hernia, prolapse, peristomal skin problems, and necrosis. Incidence rates varied widely among studies, even when the same types of complications were measured. Inadequate reporting of attrition, the number of participants at each phase of analysis, and missing data were common problems. Differences among study durations, the absence of definitions of complications, and failure to describe how complications were evaluated contributed to variability in reported complication rates. More studies are needed that use a prospective design, consistent operational definitions, and valid and reliable measurement methods. These recommendations will help increase the availability of standardized data to make comparisons among studies possible.

An introduction to genetics and application to Crohn's disease.

Gene-based diagnostics and therapeutics are being explored for application in many areas of healthcare. An understanding of the principles of genomics has become fundamental to patient care within all specialties of nursing and is expected to be included in certification exams in the near future. This introductory article is designed to provide practicing Wound, Ostomy, and Continence nurses with basic information to enhance their abilities to comprehend genetics information, apply it to practice, and translate it to colleagues and patients. Specifics about the genetic basis of Crohn's disease are used to illustrate the application of the concepts described in the article.

Use of a critical pathway for colon resections.

Tremendous variation in patient care exists, both among medical centers and among individual surgeons, in the field of colon and rectal surgery. Clinical or critical pathways based on "best demonstrated practices" from the medical literature have led to improved outcomes for many disease entities. The objective of this study was to develop a pathway for elective colon and rectal resections, and then determine whether this led to any improvement in measurable outcomes. A critical pathway was developed for the care of patients undergoing elective colon and rectal surgery, by reviewing best demonstrated practices in the literature and then developing standardized order sheets, nursing flow sheets, and patient educational material. A patient satisfaction survey was also included in the evaluation process. After being informed of the positive results from the pilot study, surgeons were encouraged to use the critical pathway order sheets, patient information sheets, and flow sheets for their patients undergoing elective abdominal colon or rectal surgery. Between January 1995 and October 1998, the critical pathway was used for 263 patients, whereas for 122 patients this pathway was not used. For those patients in the critical pathway group, the hospital length of stay was shorter (5.5 vs. 8.2 days, including the day of surgery, P = 0.001), the time until a regular diet was tolerated was shorter (3.5 vs. 4.4 days, P = 0.001), the percentage of patients discharged home was greater (90% vs. 82%, P = 0.038), and the average hospital charges were less (12,672 dollars vs. 16,665 dollars, P = 0.001). These advantages did seem to be correlated with efforts at postoperative ambulation, but were independent of the type of postoperative pain control (patient-controlled analgesia vs. epidural analgesia). Patient satisfaction in the subset surveyed was slightly better for those in the critical pathway group than in those for whom the critical pathway was not used. Elective colon and rectal surgery appears to lend itself to uniformity of postoperative order sheets and clinical expectations. Shortened lengths of hospital stay, earlier resumption of a regular diet, and diminished hospital charges were found with the use of this critical pathway, with no diminution of patients' perceptions of satisfaction with the hospital experience.