an ostomy barrier attaches to the skin around the mucocutaneous junction , where the skin meets the stoma .
a barrier that is not secure against the peristomal skin will leak effluent , which can cause skin damage ; thus , a secure seal is crucial.3 a secure seal of the ostomy barrier against the skin can be difficult to obtain , especially as the stoma and surrounding skin evolve as edema resolves during the immediate postoperative period ; when the stoma is located in a challenging anatomical position ; when the peristomal skin is uneven because of scars or skin folds ; or when the peristomal skin is fragile owing to age or cutaneous conditions . in these cases , component products
( currently classified as ostomy accessories ) such as skin barrier rings or seals , stoma paste , or barrier strips can be used to fill in and eliminate gaps , thereby creating a secure seal between the ostomy barrier and the peristomal skin.4 other components , such as adhesive removers / releasers , also may be used to support integrity of the barrier seal .
appropriate use of these components allows conventional ostomy barriers to better conform to challenging abdominal planes , thereby preventing leakage , protecting peristomal skin , and preventing the occurrence / recurrence of peristomal skin complications ( pscs ) .
reports of the incidence and prevalence of pscs vary greatly.3,5 study findings are difficult to compare due to differences in study population , study design , ostomy site , ostomy type , time since surgery , operational definitions of psc , psc assessment , and response rate.5 nevertheless , there is widespread agreement that ( 1 ) pscs are common and have a significant detrimental impact on health - related quality of life6,7 ; ( 2 ) unattended , a mild psc can progress into a more severe condition3 ; ( 3 ) peristomal leakage ( effluent on the skin ) is a key causative factor for pscs8,9 ; ( 4 ) besides discomfort and pain , damaged peristomal skin can reduce adhesion of the ostomy barrier , which , in turn , increases the risk of leakage and the necessity for frequent pouching system changes10,11 ; ( 5 ) the development of a psc often necessitates greater than usual use of ostomy supplies9 ; and ( 6 ) addressing pscs at an early stage is essential in order to avoid long - term , debilitating , and expensive complications.12 the results of a recent investigation estimating the costs associated with different forms of psc suggest that prompt management of leakage is cost - effective and exerts a positive impact on daily health - related quality of life for individuals living with an ostomy.12 in addition , clinical experience emphasizes the role of ostomy components in preventing the occurrence of common stoma - related problems.6,13 the aim of this study was to evaluate the economic and humanistic implications of using ostomy components to prevent subsequent pscs in individuals who experience an initial , leakage - related psc event .
we developed a 1 year cost - utility model to simulate a cohort of 1000 individuals living with an ostomy .
the model compares the 1-year outcomes ( psc events avoided ; quality - adjusted life days gained ) and costs ( barriers / pouches ; ostomy components ; clinical utilization ) associated with 2 scenarios : ( 1 ) a skin barrier alone scenario assumes that ostomy components are not available to manage pscs , and ( 2 ) a skin barrier and components scenario assumes that ostomy components are used selectively , with clinical oversight , to individualize barrier fit / adhesion .
proper barrier fit and adhesion are hypothesized to prevent pscs among individuals who have a first psc event .
baseline inputs for the model are drawn from published sources where available ( eg , articles identified in a medline search using key words such as  ostomy / economics  and  surgical stomas / adverse effects  ; manufacturer - suggested retail price lists ) , as indicated . where published estimates were nonspecific or unavailable , we asked a panel of 26 enterostomal therapy ( et)/woc nurses in 2 north american advisory board meetings to offer  clinically reasonable  values based on informal ( nonrandomized ) chart review and/or their clinical experience .
the nurses in our panel had an average of 11 years of clinical ostomy experience ; 2 ( a.m. , a.t . ) are authors .
all inputs were subsequently varied over a range of values to assess the robustness of modeled results .
, the model assumes hypothetically that all individuals have established a stable pattern for use of either a 1-piece or a 2-piece barrier / pouch system ( table 1 ) and have not experienced leakage - related pscs . manufacturer 's suggested retail price , british columbia , 2014 canadian dollars .
this stable pattern of ostomy supply use may be interrupted in any cycle by pscs , which are assumed to occur at an annual rate of 65% ( 5.4% per month ) . in the model
, a psc may be mild ( 25% ) , moderate ( 55% ) , or severe ( 20% ) ( table 2 ) .
these incidence and severity estimates are congruent with published literature5 and affirmed by our panel of practicing et / woc nurses . to simplify the analysis
, we assume conservatively that psc events occur at the start of a 30-day cycle and are resolved within the same cycle .
manufacturer 's suggested retail price , british columbia ; 2014 canadian dollars . versus an uncomplicated ostomy average of twice - weekly barrier changes .
barrier alone ; barrier & components ) , our baseline analysis assumes that individuals experiencing pscs will attempt to self - manage these events by increasing their usual frequency of barrier changes in an effort to minimize exposure to the irritating effluent . in some cases , more frequent pouching system changes are successful and
, individuals will seek the advice of an et / woc nurse ( table 2 ) .
for example , in the absence of ostomy components ( barrier alone scenario ) , we assume that individuals experiencing a mild psc will , in an effort to get leaking under control , increase their barrier change frequency from twice - weekly to every - other - day ( 3.5 barrier changes per week ) , which represents 175% of ( 75% increase over ) their usual use .
we further assume that this self - directed intervention is enough to enable skin healing for most ( 75% ) individuals with mild pscs .
these individuals will then return to their baseline ( twice - weekly ) frequency of barrier changes after 14 days . the remaining individuals ( 25% ) with mild pscs are assumed to consult an et / woc nurse at the end of the first 14 days . in the barrier alone scenario , adding an ostomy component ( eg , skin barrier ring or seal , stoma paste ) to individualize the fit of an ostomy barrier is not an option .
instead , our model assumes that the et / woc nurse will suggest continuing to change the ostomy barrier every - other - day for 1 more week ( total of 21 days to healing ) and will recommend that all individuals use a stoma powder and skin protectant film with each barrier change to treat the irritated peristomal skin .
individuals with a moderate psc in the barrier alone scenario are assumed to respond initially by changing their barriers daily ( 350% of their usual use ) for an average of 7 days ( table 2 ) .
self - directed care notwithstanding , we assume that all individuals with a moderate psc will eventually consult an et / woc nurse , who will suggest moving to an every - other - day barrier change schedule for 23 days ; recommend use of a stoma powder and skin protectant film with each barrier change to treat irritated skin ; and direct use of a hydrocolloid sheet , topical corticosteroid , and/or topical antifungal to help skin healing . most individuals ( 70% ) with a moderate psc will have a second visit with an et / woc nurse .
the model assumes conservatively that a moderate psc will heal within a 30-day window ( 7 days of self - care + 23 days of et / woc nurse - directed care ) , after which the individual will return to a baseline schedule of barrier changes .
similarly , individuals with severe psc are assumed to attempt self - management of leakage and skin irritation by increasing the frequency of barrier changes to once daily , although we envision that the severity of their wounds will motivate them to seek clinical attention sooner ( after 3 days ) than individuals with less severe pscs ( table 2 ) .
for these individuals , we assume that the et / woc nurse will suggest a schedule of once - daily barrier changes for 27 days ; recommend use of a stoma powder and skin protectant film with each barrier change to treat irritated skin ; and direct use of a hydrocolloid sheet , topical corticosteroid , and/or topical antifungal to aid skin healing .
most individuals ( 80% ) with a severe psc will have a second visit with an et / woc nurse ; some ( 50% ) will require a third visit . as before , the model assumes conservatively that severe pscs will heal within a 30-day window ( 3 days of self - care + 27 days of et / woc nurse - directed care ) , after which the affected individual will return to a baseline schedule of barrier changes . in the barrier and components scenario
, we assume that individuals experiencing pscs will , as before , respond by changing their ostomy barriers more frequently than usual ( table 2 ) .
however , in contrast to the barrier alone scenario and in keeping with our premise that ostomy components are used with clinical oversight , our analysis assumes that all individuals who experience psc will consult an et / woc nurse .
the nurse will recommend a clinically appropriate component to stop leakage by improving the individual fit / adhesion of the ostomy barrier ( table 3 ) .
we assume that the et / woc nurse will still direct individuals to increase their barrier change frequency to allow the pscs to heal but , because the component improves barrier fit / adhesion , individuals will be able to resume their baseline barrier change schedule after an average of 7 ( mild / moderate pscs ) or 14 ( severe pscs ) days of specialist nurse - directed care .
furthermore , the analysis assumes that individuals in the barrier and components scenario make short - term use of a skin barrier powder and skin barrier protectant film with each barrier change to treat broken peristomal skin .
however , because of the ostomy component in this scenario , we assume the et / woc nurse will work with the patient to break the leakage cycle , resulting in relatively less use of hydrocolloid sheets , topical corticosteroids , topical antifungals , and follow - up visits compared to their counterparts in the barrier alone scenario .
in addition , we assume that individuals within the barrier and component scenario will use components for the duration of the model and change the component each time they change their ostomy barriers .
manufacturer 's suggested retail price , british columbia ; 2014 canadian dollars . our et / woc nurse panel estimated that the use of an ostomy component following a first psc reduces an individual 's risk of having a subsequent psc by 80% .
individuals who experience a second ( or third ) psc event are assumed to generate all psc - related costs , including the use of a second ( or third ) ostomy component for the duration of the model but receive no additional preventive benefit from the use of the second ( or third ) component .
those experiencing a fourth psc event are assigned a 1-time , macro - cost of $ 1200 , which is intended simply to acknowledge that individuals with chronically occurring pscs will likely require referral for more complex management .
this fixed cost does not vary by modeled scenario ( barrier alone ; barrier & components ) or by the elapsed time between the start of therapy and the occurrence of the fourth psc event .
an important outcome of any clinical intervention is the change it makes  for better or worse  in a person 's perceived state of well - being .
traditionally , preferences for certain health states are measured using an interval scale , where a score of 1.0 indicates an optimal level of health and well - being (  perfect health  ) and 0.0 indicates the worst health status possible . each health state in between
if someone experiences an improvement in his or her well - being , we say that his or her utility has increased .
if well - being declines , we say that his or her utility has decreased .
quality adjustments allow for differences in morbidity effects between alternate interventions being assessed . in the present context ,
the baseline ( reference ) utility is 1 day with uncomplicated ostomy ( 1 quality - adjusted life day , or qald ) .
disutilities ,  that are associated with a first , second , or third psc.14 these disutilities are subtracted from the baseline because they decrease the individuals ' health - related quality of life by a small amount ; this effect persists daily until the psc heals . for example
, individuals with healthy peristomal skin ( no psc ) are assumed to have a qald of 0.754 ( ie , about 75% of the quality of life they would have in 1 day of perfect health ) . having a mild psc
reduces that quality of life by 0.0057 units , every day , for the duration of the psc .
thus , the daily quality of life for an individual with a mild psc is ( 0.754  0.0057 =) 0.647 ( table 4 ) .
the exception is that individuals experiencing a fourth psc , the maximum number allowed in the model , are assumed to accrue 0.647 qald ( 0.754  0.165 ) , every day , not just for the duration of the psc , but for the duration of the modeled year .
abbreviations : psc , peristomal skin complication ; qald , quality - adjusted life day . reprinted with permission from nichols.14 running
the model considers all of the baseline assumptions together to simulate the 1-year experience of individuals in each scenario . during this period
, the model keeps track of individuals ' use of ostomy supplies , psc events , and direct clinical care costs , as well as the number of qald generated . at the end ,
the model compares the total number of psc events in each clinical management scenario ( barrier alone ; barrier & components ) , relative utilization of ostomy supplies and direct clinical care costs , and the number of qald arising as a result of the different strategies .
technical validity was assessed by a thorough quality check of programming and by setting inputs to extreme values .
for example , if the annual rate of pscs is set to 0% , then the model should report 0 psc events ; if 100% of psc events are assumed to be severe , then the model should calculate no utilization for mild and moderate pscs ; and so on .
in addition , 1-way sensitivity analyses were conducted on user - modifiable inputs to test the robustness of modeled observations .
baseline inputs for the model are drawn from published sources where available ( eg , articles identified in a medline search using key words such as  ostomy / economics  and  surgical stomas / adverse effects  ; manufacturer - suggested retail price lists ) , as indicated . where published estimates were nonspecific or unavailable , we asked a panel of 26 enterostomal therapy ( et)/woc nurses in 2 north american advisory board meetings to offer  clinically reasonable  values based on informal ( nonrandomized ) chart review and/or their clinical experience .
the nurses in our panel had an average of 11 years of clinical ostomy experience ; 2 ( a.m. , a.t . ) are authors .
all inputs were subsequently varied over a range of values to assess the robustness of modeled results .
, the model assumes hypothetically that all individuals have established a stable pattern for use of either a 1-piece or a 2-piece barrier / pouch system ( table 1 ) and have not experienced leakage - related pscs .
manufacturer 's suggested retail price , british columbia , 2014 canadian dollars . this stable pattern of ostomy supply use may be interrupted in any cycle by pscs , which are assumed to occur at an annual rate of 65% ( 5.4% per month ) . in the model
, a psc may be mild ( 25% ) , moderate ( 55% ) , or severe ( 20% ) ( table 2 ) .
these incidence and severity estimates are congruent with published literature5 and affirmed by our panel of practicing et / woc nurses . to simplify the analysis
, we assume conservatively that psc events occur at the start of a 30-day cycle and are resolved within the same cycle . abbreviation : psc , peristomal skin complication .
manufacturer 's suggested retail price , british columbia ; 2014 canadian dollars . versus an uncomplicated ostomy average of twice - weekly barrier changes .
( barrier alone ; barrier & components ) , our baseline analysis assumes that individuals experiencing pscs will attempt to self - manage these events by increasing their usual frequency of barrier changes in an effort to minimize exposure to the irritating effluent . in some cases , more frequent pouching system changes are successful and
in other cases , individuals will seek the advice of an et / woc nurse ( table 2 ) .
for example , in the absence of ostomy components ( barrier alone scenario ) , we assume that individuals experiencing a mild psc will , in an effort to get leaking under control , increase their barrier change frequency from twice - weekly to every - other - day ( 3.5 barrier changes per week ) , which represents 175% of ( 75% increase over ) their usual use .
we further assume that this self - directed intervention is enough to enable skin healing for most ( 75% ) individuals with mild pscs .
these individuals will then return to their baseline ( twice - weekly ) frequency of barrier changes after 14 days .
the remaining individuals ( 25% ) with mild pscs are assumed to consult an et / woc nurse at the end of the first 14 days . in the barrier alone
scenario , adding an ostomy component ( eg , skin barrier ring or seal , stoma paste ) to individualize the fit of an ostomy barrier is not an option .
instead , our model assumes that the et / woc nurse will suggest continuing to change the ostomy barrier every - other - day for 1 more week ( total of 21 days to healing ) and will recommend that all individuals use a stoma powder and skin protectant film with each barrier change to treat the irritated peristomal skin .
individuals with a moderate psc in the barrier alone scenario are assumed to respond initially by changing their barriers daily ( 350% of their usual use ) for an average of 7 days ( table 2 ) .
self - directed care notwithstanding , we assume that all individuals with a moderate psc will eventually consult an et / woc nurse , who will suggest moving to an every - other - day barrier change schedule for 23 days ; recommend use of a stoma powder and skin protectant film with each barrier change to treat irritated skin ; and direct use of a hydrocolloid sheet , topical corticosteroid , and/or topical antifungal to help skin healing . most individuals ( 70% ) with a moderate psc will have a second visit with an et / woc nurse .
the model assumes conservatively that a moderate psc will heal within a 30-day window ( 7 days of self - care + 23 days of et / woc nurse - directed care ) , after which the individual will return to a baseline schedule of barrier changes .
similarly , individuals with severe psc are assumed to attempt self - management of leakage and skin irritation by increasing the frequency of barrier changes to once daily , although we envision that the severity of their wounds will motivate them to seek clinical attention sooner ( after 3 days ) than individuals with less severe pscs ( table 2 ) .
for these individuals , we assume that the et / woc nurse will suggest a schedule of once - daily barrier changes for 27 days ; recommend use of a stoma powder and skin protectant film with each barrier change to treat irritated skin ; and direct use of a hydrocolloid sheet , topical corticosteroid , and/or topical antifungal to aid skin healing .
most individuals ( 80% ) with a severe psc will have a second visit with an et / woc nurse ; some ( 50% ) will require a third visit . as before , the model assumes conservatively that severe pscs will heal within a 30-day window ( 3 days of self - care + 27 days of et / woc nurse - directed care ) , after which the affected individual will return to a baseline schedule of barrier changes . in the barrier and components scenario
, we assume that individuals experiencing pscs will , as before , respond by changing their ostomy barriers more frequently than usual ( table 2 ) .
however , in contrast to the barrier alone scenario and in keeping with our premise that ostomy components are used with clinical oversight , our analysis assumes that all individuals who experience psc will consult an et / woc nurse .
the nurse will recommend a clinically appropriate component to stop leakage by improving the individual fit / adhesion of the ostomy barrier ( table 3 ) .
we assume that the et / woc nurse will still direct individuals to increase their barrier change frequency to allow the pscs to heal but , because the component improves barrier fit / adhesion , individuals will be able to resume their baseline barrier change schedule after an average of 7 ( mild / moderate pscs ) or 14 ( severe pscs ) days of specialist nurse - directed care .
furthermore , the analysis assumes that individuals in the barrier and components scenario make short - term use of a skin barrier powder and skin barrier protectant film with each barrier change to treat broken peristomal skin .
however , because of the ostomy component in this scenario , we assume the et / woc nurse will work with the patient to break the leakage cycle , resulting in relatively less use of hydrocolloid sheets , topical corticosteroids , topical antifungals , and follow - up visits compared to their counterparts in the barrier alone scenario .
in addition , we assume that individuals within the barrier and component scenario will use components for the duration of the model and change the component each time they change their ostomy barriers .
manufacturer 's suggested retail price , british columbia ; 2014 canadian dollars . our et / woc nurse panel estimated that the use of an ostomy component following a first psc reduces an individual 's risk of having a subsequent psc by 80% .
individuals who experience a second ( or third ) psc event are assumed to generate all psc - related costs , including the use of a second ( or third ) ostomy component for the duration of the model but receive no additional preventive benefit from the use of the second ( or third ) component .
those experiencing a fourth psc event are assigned a 1-time , macro - cost of $ 1200 , which is intended simply to acknowledge that individuals with chronically occurring pscs will likely require referral for more complex management .
this fixed cost does not vary by modeled scenario ( barrier alone ; barrier & components ) or by the elapsed time between the start of therapy and the occurrence of the fourth psc event .
an important outcome of any clinical intervention is the change it makes  for better or worse  in a person 's perceived state of well - being .
traditionally , preferences for certain health states are measured using an interval scale , where a score of 1.0 indicates an optimal level of health and well - being (  perfect health  ) and 0.0 indicates the worst health status possible .
each health state in between is assigned a preference weight , or utility , ranging from 0.0 to 1.0 .
if someone experiences an improvement in his or her well - being , we say that his or her utility has increased . if well - being declines , we say that his or her utility has decreased .
quality adjustments allow for differences in morbidity effects between alternate interventions being assessed . in the present context , the baseline ( reference ) utility is 1 day with uncomplicated ostomy ( 1 quality - adjusted life day , or qald ) .
disutilities ,  that are associated with a first , second , or third psc.14 these disutilities are subtracted from the baseline because they decrease the individuals ' health - related quality of life by a small amount ; this effect persists daily until the psc heals .
for example , individuals with healthy peristomal skin ( no psc ) are assumed to have a qald of 0.754 ( ie , about 75% of the quality of life they would have in 1 day of perfect health ) . having a mild psc reduces that quality of life by 0.0057 units , every day , for the duration of the psc .
thus , the daily quality of life for an individual with a mild psc is ( 0.754  0.0057 =) 0.647 ( table 4 ) .
the exception is that individuals experiencing a fourth psc , the maximum number allowed in the model , are assumed to accrue 0.647 qald ( 0.754  0.165 ) , every day , not just for the duration of the psc , but for the duration of the modeled year .
abbreviations : psc , peristomal skin complication ; qald , quality - adjusted life day . reprinted with permission from nichols.14
running the model considers all of the baseline assumptions together to simulate the 1-year experience of individuals in each scenario . during this period , the model keeps track of individuals ' use of ostomy supplies , psc events , and direct clinical care costs , as well as the number of qald generated . at the end ,
the model compares the total number of psc events in each clinical management scenario ( barrier alone ; barrier & components ) , relative utilization of ostomy supplies and direct clinical care costs , and the number of qald arising as a result of the different strategies .
technical validity was assessed by a thorough quality check of programming and by setting inputs to extreme values . for example , if the annual rate of pscs is set to 0% , then the model should report 0 psc events ; if 100% of psc events are assumed to be severe , then the model should calculate no utilization for mild and moderate pscs ; and so on .
in addition , 1-way sensitivity analyses were conducted on user - modifiable inputs to test the robustness of modeled observations .
when compared to the barrier alone scenario , the barrier and components scenario resulted in 130 fewer psc events ( 520 vs 650 ) over the course of 12 months ( table 5 ) . specifically , fewer individuals had repeat pscs in the barrier and components scenario compared to those in the barrier alone arm ( 3% vs 14% ) .
individuals in the barrier and components scenario accrued 1043 more qald over the course of the modeled year compared with their counterparts in the barrier alone scenario ( 270,538 vs 269,495 ) .
thus , each psc event avoided via the use of ostomy components yielded , on average , 8 additional qald during the modeled year ( 1043 qald gained  130 psc events avoided ) .
the incremental resource use for ostomy components in the barrier and components scenario ( $ 224 ) was offset by lower average resource use for supplies ( barriers ; pouches ) ( $ 2061 vs $ 2109 ) and lower clinical utilization ( $ 54 vs $ 91 ) than the barrier alone scenario .
overall , we found that per capita annual resource use was about 6.3% ( $ 139 ) higher in the barrier and components scenario ( table 5 ) .
one - way sensitivity analyses on user - modifiable input variables support the robustness of model findings .
our analysis is most sensitive to assumptions about ( 1 ) the increased use of ostomy supplies among individuals who experience pscs ( ie , the additional frequency with which barriers are changed coupled with time to healing ) and ( 2 ) the cost of ostomy components . all other things being equal , individuals with pscs for whom ostomy components are unavailable will consume relatively more ostomy supplies ( barriers ; pouches ) and have worse outcomes ( more repeat psc events ; fewer qald ) over the course of a year .
individuals with psc for whom ostomy components are used to resolve issues of barrier fit and adhesion will have component acquisition costs ( offset in whole or in part by the use of relatively fewer barriers / pouches ) as well as better outcomes ( fewer repeat psc events ; more qald ) over the course of a year .
one - way sensitivity analyses on user - modifiable input variables support the robustness of model findings .
our analysis is most sensitive to assumptions about ( 1 ) the increased use of ostomy supplies among individuals who experience pscs ( ie , the additional frequency with which barriers are changed coupled with time to healing ) and ( 2 ) the cost of ostomy components . all other things being equal , individuals with pscs for whom ostomy components are unavailable will consume relatively more ostomy supplies ( barriers ; pouches ) and have worse outcomes ( more repeat psc events ; fewer qald ) over the course of a year .
individuals with psc for whom ostomy components are used to resolve issues of barrier fit and adhesion will have component acquisition costs ( offset in whole or in part by the use of relatively fewer barriers / pouches ) as well as better outcomes ( fewer repeat psc events ; more qald ) over the course of a year .
our analysis of 1000 hypothetical individuals with an ostomy estimated that the use of components following a first psc would result in 130 fewer psc events over the course of 1 year versus psc management without components . in this analysis ,
the costs of ostomy components were offset by lower resource use for other ostomy supplies ( barriers ; pouches ) and lower clinical utilization to manage pscs .
overall , annual average resource use was about 6.3% ( $ 139 per individual ) higher when ostomy components were used with clinical oversight , compared to a strategy of managing pscs without ostomy components . each psc event avoided via the use of ostomy components yielded , on average , 8 additional qald over the modeled year .
our analysis was most sensitive to assumptions about the increased use of ostomy supplies ( barriers ; pouches ) among individuals who experience pscs ( ie , the additional frequency with which barriers are changed coupled with the time to healing ) and the cost of ostomy components . in general , our model demonstrates that when ostomy components are used successfully to address issues of barrier fit / adhesion , individuals will ( 1 ) generate component acquisition costs that are offset in whole or in part by the consumption of relatively fewer ostomy supplies and ( 2 ) have better outcomes ( fewer repeat psc events ; more qald ) over the course of a year compared to a strategy of psc management without components .
first , there is little published evidence from which to draw baseline model inputs . in its absence , we relied heavily on the experience of a panel of et / woc nurses in active practice .
related to this is the observation that ostomy practice patterns ( eg , usual barrier change schedules ; standards of care for psc ) vary nationally , regionally , and even locally , making it impossible to create a single , broadly applicable set of baseline assumptions .
nevertheless , the decision model we constructed applies a consistent theoretical framework to clarify immediate and downstream cost and outcome tradeoffs between alternative therapeutic approaches . by design ,
the baseline assumptions of a model are easily changed in light of new information and/or to meet the needs and local clinical practices of decision makers .
second , our model takes a conservative position regarding the severity mix of pscs ; specifically , that psc severity will remain the same whether or not ostomy components are used .
however , to the extent that ostomy components prevent leakage , as they are designed to do , it is conceivable that any subsequent pscs may be milder than would be anticipated if pscs were managed without components .
third , depending on the circumstances , an et / woc nurse evaluating a leakage - related psc might not suggest adding an ostomy component but , instead , might appropriately recommend use of a differently sized barrier , or a switch from a flat - barrier to a convex - barrier in order to improve the barrier 's seal with the abdominal skin .
our analysis does not consider these therapeutic options , which also have the potential to reduce the recurrence of pscs for some individuals , albeit with a higher unit cost per barrier .
finally , the model assumes conservatively that all pscs are resolved within a 30-day window .
however , at least one cross - sectional study found that , in 76% of patients with pscs , the issues took more than 3 months to resolve.3 indeed , without components to prevent recurring leakage , stepping up the frequency of barrier changes is one of the few ways individuals have to manage and prevent pscs . for some , the increased use of ostomy supplies ( barriers ; pouches ) triggered by a first psc may become their  new normal  rather than an acute intervention .
when this is the case , the additional use of ostomy supplies will quickly exceed the cost of using an ostomy component to improve barrier fit / adhesion from the outset , again adding strength to our conclusions .
ostomy components used with clinical oversight may prevent psc by improving barrier fit / adhesion . in our analysis , ( 1 ) acquisition costs for ostomy components were offset in whole or in part the use of fewer ostomy supplies to manage pscs and ( 2 ) use of ostomy components to prevent pscs produced better outcomes ( fewer repeat psc events ; more qald ) over 1 year compared to not using components .
 purpose : the aim of this study was to evaluate the economic and humanistic implications of using ostomy components to prevent subsequent peristomal skin complications ( pscs ) in individuals who experience an initial , leakage - related psc event.design:cost-utility analysis.methods:we developed a simple decision model to consider , from a payer 's perspective , pscs managed with and without the use of ostomy components over 1 year . 
 the model evaluated the extent to which outcomes associated with the use of ostomy components ( psc events avoided ; quality - adjusted life days gained ) offset the costs associated with their use.results:our base case analysis of 1000 hypothetical individuals over 1 year assumes that using ostomy components following a first psc reduces recurrent events versus psc management without components . in this analysis , 
 component acquisition costs were largely offset by lower resource use for ostomy supplies ( barriers ; pouches ) and lower clinical utilization to manage pscs . 
 the overall annual average resource use for individuals using components was about 6.3% ( $ 139 ) higher versus individuals not using components . 
 each psc event avoided yielded , on average , 8 additional quality - adjusted life days over 1 year.conclusions:in our analysis , ( 1 ) acquisition costs for ostomy components were offset in whole or in part by the use of fewer ostomy supplies to manage pscs and ( 2 ) use of ostomy components to prevent pscs produced better outcomes ( fewer repeat psc events ; more health - related quality - adjusted life days ) over 1 year compared to not using components . 
Introduction
Methods
Model Inputs
Health-Related Quality of Life
Running the Model
Model Validation
Results
Sensitivity Analysis
Discussion
Conclusions