The Nordic Consensus Study
Conditions: Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy, Colostomy Stoma
Sponsor: Coloplast A/S

 
 
 
Study Protocol 
The Nordic Consensus Study – Evaluation of the consensus guidelines in 
clinical practice 
Study ID: CP339 
 
 
 
 
Document approval date (DD-MM-YYYY):  10-11-2020 

 
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CONTENTS  
 
1. 
Background .................................................................................................................................................................................. 3 
2. 
Hypothesis .................................................................................................................................................................................... 3 
3. 
Objectives ...................................................................................................................................................................................... 3 
3.1. 
The primary objective .......................................................................................................................................................... 3 
3.2. 
The secondary objectives ................................................................................................................................................... 4 
4. 
Study design ................................................................................................................................................................................. 4 
5. 
Inclusion- and exclusion criteria ............................................................................................................................................ 5 
5.1. 
Inclusion criteria ..................................................................................................................................................................... 5 
5.2. 
Exclusion criteria.................................................................................................................................................................... 5 
6. 
Number of patients with rationale for choice ................................................................................................................... 6 
7. 
Statistical considerations ......................................................................................................................................................... 6 
8. 
Primary and secondary outcomes ....................................................................................................................................... 6 
8.1. 
Primary outcome................................................................................................................................................................... 6 
8.2. 
Secondary outcomes ........................................................................................................................................................... 7 
9. 
Comparison or control group ................................................................................................................................................. 7 
10. Study follow-up schedule ........................................................................................................................................................ 7 
11. References .................................................................................................................................................................................... 7 
12. Appendix A - Body Assessment Tool .................................................................................................................................. 8 
13. Appendix B - Nurse Evaluation Tool ................................................................................................................................. 10 
14. Appendix C – The OLI Score ................................................................................................................................................ 13 
15. Appendix D – The Leakage Quesionnaire ....................................................................................................................... 17 
 
 

 
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1. 
Background 
Leakage is a big concern for ostomates. In a global survey conducted by Coloplast (n=5187) (1) - the Ostomy 
Life Study 2019 – 32 % experienced leakage once a week and 27% experienced leakage onto their clothes 
every month. 92 % of people living with an ostomy worry about leakage. Leakage has severe consequences 
such as skin complications and social isolation. If ostomates have skin complications, 58 % consider output 
under the baseplate to be the cause, 66 % say it to some degree impacts their ability to work and 20 % rarely 
leaves home due to fear of leakage. 26% say that difficulties getting a good fit of the stoma appliance is the 
main reason for leakage. 
 
The Body Assessment Tool has been created to help better understand what products to use for individual 
peristomal body profiles. Individuals with a stoma have very different peristomal body profiles which 
sometimes require ostomy products that are designed to meet special shaping needs. The Body Assessment 
Tool is a 6- step assessment tool based on the newly developed consensus guidelines among stoma care 
nurses. 
 
An article has been published in British Journal of Nursing (2) about the consensus guidelines to encourage 
nurses to choose ostomy products based on assessment of the individual body profile of the user. The paper 
shows how the consensus guidelines were developed and presents concept and purpose of the 6 steps in the 
Body Assessment Tool in hope of providing nurses a more structured and “right from the start” approach 
when choosing ostomy products. However, the Body Assessment Tool needs to be evaluated in clinical 
settings to document the usability among nurses and to explore its impact on selection of ostomy product(s) 
together with a potential improvement of leakage incidences and the user’s leakage-related quality of life 
using the validated OLI score (Ostomy Leakage Impact Tool)(3).  
 
Furthermore, it is of interest to explore usability of The Body Assessment Tool in the group of newly stoma 
patients (i.e. newly patient discharged (NPD)) as they may have a potentially larger extent of change of their 
peristomal body profile post-surgery compared to experienced people with a stoma (i.e. veterans). A 
subgroup of NPDs will therefore be recruited at one clinical site,  
Meilahden tornisairaala, Finland 
. 
 
 
2. 
Hypothesis 
The hypothesis is that with the Body Assessment Tool in combination with the use of the current guidelines 
and practices, nurses will be able in a standardised way to choose the most appropriate ostomy product(s) 
for the given user and may thereby help improving the QoL of the user by reducing the users concerns about 
leakage and preventing the incidences of leakage.  
 
3. 
Objectives 
3.1. 
The primary objective  
• 
To evaluate the usability of the 6- step Body Assessment Tool in clinical settings (performed by the 
nurse) – see appendix A. For the usability evaluation a questionnaire has been prepared, theNurse 
Evaluation Form  – see appendix B. 
 

 
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3.2. 
The secondary objectives  
• 
To explore if the use of Body Assessment Tool and related change of ostomy product(s) have an 
impact on the leakage associated QoL (based on the OLI score)- see appendix C. The OLI score 
includes three domain scores: 
- 
emotional impact 
- 
usual and social activities 
- 
coping and in control 
• 
To evaluate the incidences of leakage before and after change of ostomy product(s) (the question 
will be included in a leakage questionnaire in addition to the OLI score – see appendix D).  
 
4. 
Study design 
The study is a 1-sequential, 1-arm, non-randomised, non-blinded, multi-center (between 20 to 40 sites in 
total) non-interventional 4-5-week clinical investigation in which the Body Assessment Tool will be evaluated 
for its usability by ostomy nurses using the Nurse Evaluation Form and to explore if the change of ostomy 
product(s) can reduce the user’s concerns about leakage and have a positive impact on QoL related to 
leakage (estimated by the OLI score). For evaluation of the number of leakage incidences the last 7 days pre-
and post-change of ostomy products a questionnaire is prepared including a definition of leakage and images 
for support. 
 
Blinding is not applicable as change of ostomy product(s) cannot be blinded for either the user or nurse. 
Randomization is not applicable as there will be no comparison to a specific ostomy product or control group. 
The subjects will change their ostomy product(s) based on their individual body profile assessment and the 
selection of ostomy products will vary in between subjects and will not be dictated by this protocol.  
 
The NPD subgroup will follow the same protocol as the veterans. However, the data (NPDs vs. veterans) will 
not be compared due the potentially difference in the change of peristomal body profile. The NPD data will 
be regarded and handled as exploratory.   
 
All assessments will be based on questionnaires either completed by the nurse or user. Usability data will only 
be analyzed using descriptive methods. Whereas the OLI score results will be analyzed by descriptive methods 
(sub-questions in OLI score) and paired t-test (domain scores). The number of leakage episodes will be 
analyzed by paired t-test. 
 
The study will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit). 
The number of phone calls will vary depending on the user’s need for support.   
 
Prior to screening the nurse identifies potential patients who require a re-evaluation of their current ostomy 
products due to ongoing product issues (please refer to section 5 ‘In- and exclusion criteria’). If the patient is 
interested in study participation the subject must sign an informed consent after having received verbally and 
written information about the study. When signed the subject can undergo the screening assessment and if 
found eligible the subject can be enrolled in the study.  
 
Following enrollment, the nurse will perform body profile assessment (the stoma and peristomal area) of the 
subject using the Body Assessment Tool. Based on the result the nurse will select the most appropriate 
ostomy product(s) for the subject. The body assessment tool that has been filled out for each participant will 
be stored in the study participant file. At the visit the subject will also be asked to evaluate the impact of 
leakage and fear of leakage on their QoL using the OLI-score together with recalling the number of leakage 
incidences the last 7 days. This questionnaire will also be stored in the study participation file. The participant 

 
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will leave the clinic with new ostomy products and be instructed to use them for the next 4-5 weeks. The 
participant will also receive a second questionnaire to be filled in at home after 4-5 weeks. 
 
After 4-5 weeks, the nurse will contact the subject by phone or in a new scheduled visit to the clinic to remind 
the participant, if needed,  to evaluate the impact of leakage on QoL/fear of leakage using the OLI score 
together with recalling the number of leakage incidences in the last 7 days. The subjects will send the 
questionnaires with a patient code directly to Coloplast.  Patients will be encouraged to send in the second 
questionnaire even if they have discontinued using the recommended ostomy products also to know the 
reason for discontinuation.  
 
After all subjects at a given study site have been included, the nurse will evaluate the Body Assessment Tool 
based on his/her experience of the tool in the clinic, using the Nurse Evaluation Form. 
 
Anonymous data – including the questionnaire and the body assessment tool for each participant and the 
Nurse Evaluation Form will be sent to Coloplast for analysis.  
 
5. 
Inclusion- and exclusion criteria 
5.1. 
Inclusion criteria for veterans 
• 
Adult, aged: ≥18 
• 
Male or female individual with a stoma 
• 
Stoma debut for ≥ 3 months  
• 
Individual who require a re-evaluation of ostomy product(s) in a stoma care clinic due to issues with 
leakage  
• 
Must have provided a written informed consent for participation in the study prior to any specific 
procedures  
 
5.2. 
Inclusion criteria for NPD subgroup 
• 
Adult, aged: ≥18 
• 
Male or female individual with a stoma 
• 
Stoma debut for < 3 months  
• 
Must have provided a written informed consent for participation in the study prior to any specific 
procedures  
 
5.3. 
Exclusion criteria for veterans and NPDs 
The subject will not be eligible for enrollment if the subject: 
• 
Requires a caretaker to change ostomy product(s) on the user 
• 
Is pregnant (mainly due to substantial change of body profile during intervention) 
• 
Is lactating (mainly due to potential weight loss and substantial change of body profile during the 
intervention)   
• 
Does not have the resources personally, mentally, or physically to participate in the intervention 
(judged by the ostomy nurse)  
• 
Changes his/her ostomy products (bag or plate) during the intervention period (withdraw of data) 
 
 

 
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6. 
Number of patients with rationale for choice 
A minimum of 160 subjects will be enrolled in the study. At least 40 individuals with a stoma will be enrolled 
from each Nordic country (i.e. Denmark, Sweden, Norway and Finland). The subjects will be recruited from at 
least 3 clinics in each country and each clinic will recruit at least 5 participants to the study. The total number 
of participants is based on what seems feasible to enroll. As the primary endpoint will be presented using 
descriptive methods there is no requirements on the sample size.   
 
The OLI score results are not the primary outcome of the study and the >160 numbers of subjects are 
sufficient. 
 
7. 
Statistical considerations  
Data from the Nurse Evaluation Form will be presented using descriptive methods.  
 
The OLI score will be presented using both descriptive methods (i.e. sub-questions) and quantitative methods 
(i.e. the 3 domain scores: ‘emotional impact’, ‘usual and social activities’ and ‘coping and in control’).  
 
Change of the domain scores ‘emotional impact’, ‘usual and social activities’ and ‘coping and in control’ and 
number of leakages pre-and post-transition of ostomy products will be analyzed by using paired t-test. All 
three domain scores are designed to range from 0-100. Higher scores represent better levels of functioning.  
The domain scores will be calculated as mean of the responses to each question or item within a domain (the 
method to estimate the domain scores is described in Appendix C).   
 
The number of leakage episodes/7 days) will be analysed by quantitative methods (paired t-test). 
 
The exploratory NPD data from the clinical site Meilahden tornisairaala, Finland will not be pooled with the 
veteran data as the two groups can be potentially very different in the change of peristomal body profiles 
during the study period. This makes the two groups less comparable and the NPD data will therefore be 
analysed separately.   
 
There will be no comparison to other types of products or body assessment tools. In case subjects change to 
other ostomy products during the intervention period the data of the given subject will not be included in the 
final data of the study.  
 
 
8. 
Primary and secondary outcomes  
8.1. 
Primary outcome  
• 
The usability of the Body Assessment Tool will be based on the Nurse Evaluation Form including the 
following questions (evaluation performed by the nurse) (6-point scale):  
- 
How well does the Body Assessment Tool work in a clinical setting?  
- 
How well does the assessment of the user’s body profile work prior to selecting ostomy 
product(s)?  
- 
Do you experience that the Body Assessment Tool supports you to increase the quality of the 
treatment? 
 

 
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8.2. 
Secondary outcomes 
• 
Rating of the user’s leakage associated QoL the last 7 days (i.e. 4-point scale sub-questions) before 
and after ostomy product change  
• 
Change in domain scoring of fear of leakage and the impact on QoL pre- and post-transition of 
ostomy product(s):  
- 
emotional impact 
- 
usual and social activities 
- 
coping and in control 
• 
Number of self-reported retrospective incidences of leakage the last 7 days on prior to and after 
transition to more appropriate ostomy product(s)   
• 
 
• 
Analysis of connection between body profile, product solution and incidence of leakage 
 
9. 
Comparison or control group 
There will be no comparison to other types of products, body assessment tools or control groups.  
 
Each subject will act as their own control when analysing the difference in the OLI score and number of 
leakage incidences pre-and post-transition of ostomy product(s).  
 
10. Study follow-up schedule 
No follow-up visits or contact with the users are included in the study  
 
 
11. References 
1. Ostomy Life Study 2019, Global Report, Data-on-file, PM-10499  
2. James-Reid S, Bain K, Hansen AS, Vendelbo G, Droste W, Colwell J. Creating consensus-based 
practice guidelines with 2000 nurses. Br J Nurs. 2019; 28: S18-S25  
3. Nafees B, Störling Z, Hindsberger C, Lloyd A. The Ostomy leak impact tool: development and 
validation of a new patient-reported tool to measure the burden of leakage in ostomy device users. 
Health and Quality of Life Outcomes. 2018; 16:231 
 

 
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12. Appendix A - Body Assessment Tool 
 
 

 
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13.  Appendix B - Nurse Evaluation Tool 
 
 
 
 
 
 
 

 
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14. Appendix C – The OLI Score 
The below tables show the scoring weights for each item from the OLI score questionnaire. 
 
 
Domain score 1. Emotional impact 
 
When you thought about your ostomy device and the risk of leakage, what emotions did you feel? 
 
 
In the last 7 days, due to 
leakage or worry about 
leakage… 
All of the time 
Often  
Sometimes 
Rarely or never 
1. I felt panic 
 
0 
1 
2 
3 
2. I felt stressed out 
 
0 
1 
2 
3 
3. I felt more afraid about 
leaks in the future  
 
0 
1 
2 
3 
4. I felt worry 
 
0 
1 
2 
3 
5. I felt frustrated 
 
0 
1 
2 
3 
6. I felt embarrassed 
 
0 
1 
2 
3 
7. I felt worried that I might 
leak 
0 
1 
2 
3 
8. I couldn't sleep  
0 
1 
2 
3 
9. I kept waking up at night to 
check my stoma  
0 
1 
2 
3 
10. 
 I kept 
checking my ostomy bag to 
see if I have leaked  
0 
1 
2 
3 
 
 
 
 
 

 
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Domain score 2. Usual and Social activities 
 
When you thought about your ostomy device and the risk of leakage, how did it affect your activities? 
 
 
In the last 7 days due to 
leakage or worry about 
leakage… 
All of the time 
Often  
Sometimes 
Rarely or never 
Not 
applicable 
 
 
 
 
 
 
11. I decided to stay at home  
0 
1 
2 
3 
9 
12. I couldn't do light 
activities  
0 
1 
2 
3 
9 
13. I changed my plans  
0 
1 
2 
3 
9 
14. I was unable to go out and 
meet family and friends 
0 
1 
2 
3 
9 
15. 
I avoided 
close physical contact with 
family and friends  
0 
1 
2 
3 
9 
16. 
 I did not want 
to see people  
0 
1 
2 
3 
9 
17. 
I avoided 
people  
0 
1 
2 
3 
9 
18. 
I tried to avoid 
meeting new people  
0 
1 
2 
3 
9 
 
 

 
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Domain score 3. Coping and in control 
 
When you thought about your ostomy device and the risk of leakage, how did it affect your ability to cope? 
 
 
 
In the last 7 days, due to 
leakage or worry about 
leakage… 
All of the 
time 
Often  
Sometimes 
Rarely or 
never 
19. I felt in control 
 
0 
1 
2 
3 
20. I was able to cope 
 
0 
1 
2 
3 
21. I felt calm 
 
0 
1 
2 
3 
22. I saw my friends as I usually 
do 
0 
1 
2 
3 
 
 
All three domain scores are designed to range from 0-100.  Higher scores represent better levels of 
functioning.  A domain score is estimated as a mean of the responses to each question or item within a 
domain.  This is then divided by the arithmetic difference between the minimum score (0) and the maximum 
score (3) so that this number then varies between 0 and 1.  This is then rescaled between 0 -100.  It is 
important to note that some items in the questionnaire are effectively reversed scored.  The need to do this is 
accommodated by in the scoring algorithm itself rather than in the scoring weights for each question.  
Scoring formulae for the three domain scores is provided here: 
 
Emotional impact 
 
𝑆𝑐𝑜𝑟𝑒= (
∑(𝑄1, 𝑄2, … 𝑄10)
10
÷ 3 × 100) 
 
Usual & social activities 
𝑆𝑐𝑜𝑟𝑒= (
∑(𝑄11, 𝑄12, … 𝑄18)
8
÷ 3 × 100) 
 
 
Coping & in control 
𝑆𝑐𝑜𝑟𝑒= 100 − (
∑(𝑄19, 𝑄20, … 𝑄22)
4
÷ 3 × 100) 
 
 
 
 

 
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Not applicable & Missing data 
Where responses are classified as Not applicable then this should be noted in the descriptive summary of the 
data in any study report.  In addition, though for the purposes of scoring the domains these responses should 
be coded as missing data.   
 
A domain score can be estimated when at least 50% of the items within a domain have been completed.  
The scale score is estimated in the same way by taking the mean of the items that have been completed.  If 
less than 50% of the items have been completed, then the domain should not be scored for that individual.  If 
there are a high number of participants who fail to complete all the items in the survey, then this should be 
noted as a limitation in the study report.   
 
References: 
(1) Creating consensus-based guidelines with 2000 nurses, Sara James-Reid et al., British Journal of 
Nursing 2019:  https://www.magonlinelibrary.com/doi/full/10.12968/bjon.2019.28.22.S18  
 
 
 

 
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15. Appendix D – The Leakage Questionnaire 
 

 
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