Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04996186 |
| Other study ID # |
GRC 01 GREEN STAR Q |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
April 30, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Pierre and Marie Curie University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction.
Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool
developed in MS patients.
Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel
disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in
neurogenic bowel dysfunction and frequently coexist in this population, generally in
association with urinary disorders.
Because of the high prevalence of bowel disorders their and the major impact on the quality
of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum
(persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment
of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score
exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and
validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used
in research for all neurologic patients despite its lack of sensibility in various neurogenic
population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014,
there is a need of a specific evaluation for bowel symptoms in neurogenic population,
especially for PwMS.
The aim of the study was to create and validate a new multidimensional questionnaire to
assess bowel dysfunction and impact on quality of life in patients with MS.
The investigators conducted a prospective multicenter study (8 centers) between June 2019 to
April 2021. This study was developed in 3 steps. First step was literature review and
qualitative interview. Then the second step was the feasibility study to evaluate
comprehension, acceptability of the different items. The last part of the study was the
validation study of the questionnaire. This part of the study was performed between June2020
and April 2021. Validation study allowed to determine the psychometric properties of the new
tool.
Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's
criteria were included. Patients not able to read or understand the objectives and procedures
for conducting the protocol and patient who had a recent relapse of MS were excluded.
Description:
Multiple sclerosis (MS) is an autoimmune autoimmune central nervous system (CNS) disorder
characterized by demyelinisation and central neurologic damage. MS is the first cause of
disability in young adults and affects 2.8 million people in the world.
Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction.
Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool
developed in MS patients.
Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel
disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in
neurogenic bowel dysfunction and frequently coexist in this population, generally in
association with urinary disorders. Chronic constipation and fecal incontinence were defined
by Rome IV criteria. According to these criteria, constipation is a bowel disorder in which
symptoms of difficult, infrequent, or incomplete defecation predominate for at least 3 months
and fecal incontinence is defined as the recurrent uncontrolled passage of fecal material for
at least 3 months.
Moreover, neurogenic bowel dysfunction has a real impact on quality of life and can cause
social isolation.
Because of the high prevalence of bowel disorders their and the major impact on the quality
of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum
(persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment
of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score
exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and
validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used
in research for all neurologic patients despite its lack of sensibility in various neurogenic
population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014,
there is a need of a specific evaluation for bowel symptoms in neurogenic population,
especially for PwMS.
The aim of the study was to create and validate a new multidimensional questionnaire to
assess bowel dysfunction and impact on quality of life in patients with MS.
The investigators conducted a prospective multicenter study (8 centers) between June 2019 to
April 2021. This study was developed in 3 steps. First step was literature review and
qualitative interview. Then the second step was the feasibility study to evaluate
comprehension, acceptability of the different items. The last part of the study was the
validation study of the questionnaire. All these phases allowed a full psychometric
validation of the questionnaire.
Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's
criteria were included. Patients not able to read or understand the objectives and procedures
for conducting the protocol and patient who had a recent relapse of MS were excluded.
Step 1: literature review and qualitative interview. The investigators conducted a review of
literature on Pubmed to know all the existing questionnaires or tools developed and validated
to assess neurogenic bowel dysfunction in MS. All articles published until April 2020 were
included. The following keywords were used: "neurogenic bowel dysfunction", "constipation",
"fecal incontinence", "anorectal disorders", "multiple sclerosis".
In addition a single trained nurse performed qualitative interviews with patients suffering
from ano rectal disorders secondary to MS. These interviews were lead in two phases. First
part allowed to determine the wording of the different symptoms and mode of response for each
item. The second part of the face-to-face was free and patients could express themselves if
there was a gap in our list of symptoms.
During this first phase of the study a panel of 8 experts was selected, composed of neuro
urologists and gastro enterologists.
The first version of the questionnaire was made based on the patients' qualitative
interviews, on the reactions and comments of the expert team and on the literature review.
Step 2: Feasibility study The feasibility study was conducted between April 2020 and June
2020. This pilot study included 30 patients and was performed to assess comprehension,
acceptability and pertinence of the items the investigators have created to build the
questionnaire. More of response was also evaluate by patients.
Step 3: Validation study. This part of the study was performed between June2020 and April
2021. Validation study allowed to determine the psychometric properties of the new tool. All
items were discussed for ceil or floor effect by the expert team. Each item with more than
50% of patients having the same response were discussed by panel experts to decide if they
were excluded or not of the final version.
To obtain good psychometric properties, the investigators included 10 patients for each items
of the questionnaire in the final version. This number of subjects was calculated to allow
univariate and multivariate logistic regression.
Internal consistency reliability was calculated using the alpha coefficient of Cronbach. Each
response has been transformed in a numeric value to perform this test. Alpha coefficient of
Cronbach was considered as very good if > 0.7.
Test-retest reliability was tested using the intraclass correlation coefficient (ICC) which
was significant over 0.7. The first questionnaire was filled at the end of the first
consultation and patients had to mail a second questionnaire (filled at home) 7 to 14 days
after the first consultation.
Statistical analyses: Final version of STAR-Q (Symptoms and Treatment Assessment of
Ano-Rectal disorders in multiple sclerosis patients Questionnaire) was composed by 3 sub
domains. First one was symptoms, second one was treatment, and a third sub domain was quality
of life.
For each sub domains, the investigators calculated an alpha coefficient of Cronbach and a
ICC. the investigators also assessed these properties for total score.
Total score was compared to NBD total score which represents gold standard in ano rectal
disorders and thus constitutes the reference testing external consistency. Finally, PGI
(Patient Global Improvment) severity scores were used to determine category of severity for
STAR-Q scores.
All statistical analyzes were performed with the R-studio version 3.3.1 and Statviews (SAS
institute V 5.0).
