Trial Outcomes & Findings for A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas (NCT NCT04876690)
NCT ID: NCT04876690
Last Updated: 2024-08-05
Results Overview
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning.
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
At inclusion visit (Day 1)
Results posted on
2024-08-05
Participant Flow
Data from participants were collected for this cross-sectional, observational study with a retrospective component at two investigative sites in Portugal from 9 July 2021 to 27 May 2022.
Participants with a diagnosis of Crohn's disease (CD) with complex perianal fistulas (CPF) were enrolled from the investigative sites' database and were observed in a cross-sectional way along with a retrospective component to collect data for healthcare resource utilization and on the pharmacological and surgical treatments in this study.
Participant milestones
| Measure |
CD Participants With CPF
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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|---|---|
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Age, Continuous
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44.40 years
STANDARD_DEVIATION 12.39 • n=15 Participants
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Sex: Female, Male
Female
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8 Participants
n=15 Participants
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Sex: Female, Male
Male
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7 Participants
n=15 Participants
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Region of Enrollment
Portugal
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15 Participants
n=15 Participants
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Height
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168.60 centimeter
STANDARD_DEVIATION 8.28 • n=15 Participants
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Weight
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68.45 kilogram (kg)
STANDARD_DEVIATION 12.05 • n=15 Participants
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Body Mass Index (BMI)
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24.11 kg/meter^2
STANDARD_DEVIATION 4.11 • n=15 Participants
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PRIMARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis.
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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|---|---|
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Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]
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45.36 score on a scale
Standard Deviation 7.58
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PRIMARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis.
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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|---|---|
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Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])
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38.00 score on a scale
Standard Deviation 8.48
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis.
The SIBDQ is an instrument used to assess QoL and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is reported and ranges from 10 to 70 with a higher score indicating a better health-related QoL.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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|---|---|
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Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
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45.00 score on a scale
Standard Deviation 10.72
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible male participants with CD and CPAF were included in the analysis and are presented as the overall number of participants analyzed in this outcome measure.
SQOL-M assessed the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best), completely agree = 1 to completely disagree = 6. The total score can range from 11 to 66 points. Higher scores indicate better male sexual quality of life.
Outcome measures
| Measure |
CD Participants With CPF
n=7 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants
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44.57 score on a scale
Standard Deviation 14.59
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible female participants with CD and CPAF with data available for analyses were included and are presented as the overall number of participants analyzed in this outcome measure.
SQOL-F assessed the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
Outcome measures
| Measure |
CD Participants With CPF
n=5 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants
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72.80 score on a scale
Standard Deviation 25.54
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis. Overall number analyzed is the number of participants with data available for analyses.
Fecal incontinence is measured by Wexner score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that ranges from 0 to 20. Higher scores indicate worse fecal incontinence.
Outcome measures
| Measure |
CD Participants With CPF
n=14 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Fecal Incontinence as Assessed by Wexner Score
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7.43 score on a scale
Standard Deviation 5.50
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
WPAI score was used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assesses the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment / disability. Scores are presented as percentages (multiplying the scores by 100), Domain scores are expressed as a percentage, with a range of scores form 0-100%, with 0% representing no impact on productivity and 100% representing complete impact on productivity. Higher scores indicate greater impairment.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score
Absenteeism
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3.80 score on a scale
Standard Deviation 6.85
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Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score
Presenteeism
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57.78 score on a scale
Standard Deviation 29.91
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Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score
Work Productivity Loss
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58.89 score on a scale
Standard Deviation 30.28
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Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score
Activity Impairment
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52.67 score on a scale
Standard Deviation 31.27
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SECONDARY outcome
Timeframe: Up to 3 years prior to the inclusion visit at Day 1Population: All eligible participants with CD and CPAF were included in the analysis.
Number of participants characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit were collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to \[\>=\] 24 hours) due to CPF, and intensive care unit (ICU) admission. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years
Any Medical Specialty Appointments for the Management of CPF
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15 Participants
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Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years
Emergency Room Visits due to CPF
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3 Participants
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Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years
Hospitalizations (>= 24 Hours) due to CPF
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5 Participants
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis.
Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI).
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
Age: 22 to 64 Years
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15 Participants
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
Sex: Female
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8 Participants
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
Sex: Male
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7 Participants
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
BMI: Underweight
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0 Participants
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
BMI: Normal range
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9 Participants
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
BMI: Overweight
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4 Participants
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Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
BMI: Obese
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2 Participants
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis.
The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) is penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) is defined as the presence of perianal abscesses or fistulae.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Location 1: Terminal Ileum
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4 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Location 1 + 4: Terminal Ileum + Upper Gastrointestinal
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1 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Location 2: Colon
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3 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Location 3: Ileocolon
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5 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Location 3 + 4: Ileocolon + Upper Gastrointestinal
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2 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Behavior, Perianal Disease B1p: Nonstricturing, Nonpenetrating + Perianal
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8 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Behavior, Perianal Disease B2p: Stricturing + Perianal
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5 Participants
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Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
Disease Behavior, Perianal Disease B3p: Penetrating + Perianal
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2 Participants
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SECONDARY outcome
Timeframe: Up to 3 years prior to the inclusion visit at Day 1Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
For each pharmacological treatment (antibiotics, monoclonal antibodies, immunosuppressants, and others), participants were divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit. Surgical treatment in the last three years for the management of CPF was also recorded. A participant may be included in more than one category.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Past Users: Immunosuppressants
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2 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Current Users: Antibiotics
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2 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Current Users: Monoclonal Antibodies
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13 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Current Users: Immunosuppressants
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7 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Past Users: Antibiotics
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10 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Past Users: Monoclonal Antibodies
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2 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Non-users: Antibiotics
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5 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Non-users: Monoclonal Antibodies
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2 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Non-users: Immunosuppressants
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7 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Non-users: Others
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15 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Surgical Treatment in the Last Three Years for the Management of CPF- Yes
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11 Participants
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Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
Surgical Treatment in the Last Three Years for the Management of CPF- No
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1 Participants
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SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. PCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Sex- Male
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48.63 score on a scale
Standard Deviation 8.16
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Sex- Female
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42.50 score on a scale
Standard Deviation 6.15
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Employment Status- Employed
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44.01 score on a scale
Standard Deviation 7.33
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Employment Status- Unemployed
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48.22 score on a scale
Standard Deviation 12.30
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Employment Status- Retired
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48.18 score on a scale
Standard Deviation 3.49
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Employment Status- Student
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43.25 score on a scale
Standard Deviation NA
Standard deviation (SD) was not estimable due to low number of participants with event.
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Smoking Status- Never
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47.90 score on a scale
Standard Deviation 7.66
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Smoking Status- Former
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45.08 score on a scale
Standard Deviation 0.42
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Smoking Status- Current
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41.40 score on a scale
Standard Deviation 8.12
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Age at Onset of CD Diagnosis - At or Below 16 Years
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45.37 score on a scale
Standard Deviation NA
Standard deviation (SD) was not estimable due to low number of participants with event.
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Age at Onset of CD Diagnosis - Between 17 and 40 Years
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45.22 score on a scale
Standard Deviation 9.06
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Age at Onset of CD Diagnosis - Above 40 Years
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45.70 score on a scale
Standard Deviation 4.70
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Location 1- Terminal Ileum
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54.14 score on a scale
Standard Deviation 4.46
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Location 1 + 4- Terminal Ileum + Upper Gastrointestinal
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43.25 score on a scale
Standard Deviation NA
Standard deviation (SD) was not estimable due to low number of participants with event.
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Location 2- Colon
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41.14 score on a scale
Standard Deviation 4.28
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Location 3- Ileocolon
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43.64 score on a scale
Standard Deviation 6.87
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Location 3 + 4- Ileocolon + Upper Gastrointestinal
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39.47 score on a scale
Standard Deviation 8.34
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Behavior- Nonstricturing, Nonpenetrating + Perianal
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44.25 score on a scale
Standard Deviation 7.33
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Behavior- Stricturing + Perianal
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47.61 score on a scale
Standard Deviation 9.16
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Disease Behavior- Penetrating + Perianal
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44.15 score on a scale
Standard Deviation 7.40
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Extraintestinal Manifestation of CD- Yes
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49.37 score on a scale
Standard Deviation 12.60
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Extraintestinal Manifestation of CD- No
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44.74 score on a scale
Standard Deviation 7.13
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With High Intersphincteric Type- Yes
|
50.72 score on a scale
Standard Deviation 7.52
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With High Intersphincteric Type- No
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44.02 score on a scale
Standard Deviation 7.29
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With High Transsphincteric Type- Yes
|
41.58 score on a scale
Standard Deviation 3.37
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With High Transsphincteric Type- No
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46.30 score on a scale
Standard Deviation 8.14
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Suprasphincteric Type- Yes
|
38.08 score on a scale
Standard Deviation 1.18
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Suprasphincteric Type- No
|
46.48 score on a scale
Standard Deviation 7.54
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Extrasphincteric Type- Yes
|
39.64 score on a scale
Standard Deviation 8.58
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Extrasphincteric Type- No
|
46.24 score on a scale
Standard Deviation 7.39
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Superficial Type- No
|
45.36 score on a scale
Standard Deviation 7.58
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Low Intersphincteric Type- Yes
|
54.65 score on a scale
Standard Deviation 3.94
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Low Intersphincteric Type- No
|
43.93 score on a scale
Standard Deviation 7.02
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Low Transsphincteric Type- Yes
|
42.89 score on a scale
Standard Deviation 7.61
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Low Transsphincteric Type- No
|
45.98 score on a scale
Standard Deviation 7.78
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Midline Position- Yes
|
46.12 score on a scale
Standard Deviation 8.04
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Midline Position- No
|
43.26 score on a scale
Standard Deviation 6.71
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Lateral Position- Yes
|
43.77 score on a scale
Standard Deviation 6.43
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Lateral Position- No
|
46.42 score on a scale
Standard Deviation 8.46
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Seton- Yes
|
43.71 score on a scale
Standard Deviation 4.71
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Fistula With Seton- No
|
47.25 score on a scale
Standard Deviation 10.02
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Harvey-Bradshaw Index (HBI) Category- Remission
|
46.62 score on a scale
Standard Deviation 7.93
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: HBI Category- Mild Activity
|
38.85 score on a scale
Standard Deviation 2.28
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: HBI Category- Moderate Activity
|
43.25 score on a scale
Standard Deviation NA
Standard deviation (SD) was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Treatment-naïve- Yes
|
34.51 score on a scale
Standard Deviation NA
Standard deviation (SD) was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Treatment-naïve- No
|
46.13 score on a scale
Standard Deviation 7.23
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery-naïve- Yes
|
37.93 score on a scale
Standard Deviation 6.75
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery-naïve- No
|
47.22 score on a scale
Standard Deviation 6.79
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Fistulotomy- Yes
|
45.08 score on a scale
Standard Deviation 0.42
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Fistulotomy- No
|
45.40 score on a scale
Standard Deviation 8.19
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Advancement Flap- No
|
45.36 score on a scale
Standard Deviation 7.58
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - LIFT- No
|
45.36 score on a scale
Standard Deviation 7.58
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Fibrin Glue- No
|
45.36 score on a scale
Standard Deviation 7.58
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Anal Fistula Plug- No
|
45.36 score on a scale
Standard Deviation 7.58
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Defunctioning Stoma- No
|
45.36 score on a scale
Standard Deviation 7.58
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Cutting Seton- No
|
45.36 score on a scale
Standard Deviation 7.58
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Loose Seton- Yes
|
46.56 score on a scale
Standard Deviation 6.98
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Loose Seton- No
|
43.56 score on a scale
Standard Deviation 8.76
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Other- Yes
|
47.28 score on a scale
Standard Deviation 6.77
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Surgery - Other- No
|
44.66 score on a scale
Standard Deviation 8.05
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Presence of Perianal Abscess- Yes
|
47.57 score on a scale
Standard Deviation 7.88
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Presence of Perianal Abscess- No
|
43.88 score on a scale
Standard Deviation 7.47
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
PCS-12: Presence of Anorectal Stricture- No
|
45.36 score on a scale
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. MCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
|
|---|---|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Sex- Male
|
36.27 score on a scale
Standard Deviation 5.60
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Sex- Female
|
39.51 score on a scale
Standard Deviation 10.56
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Employment Status- Employed
|
35.84 score on a scale
Standard Deviation 9.17
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Employment Status- Unemployed
|
41.22 score on a scale
Standard Deviation 7.89
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Employment Status- Retired
|
45.19 score on a scale
Standard Deviation 3.63
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Employment Status- Student
|
33.45 score on a scale
Standard Deviation NA
SD was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Smoking Status- Never
|
38.54 score on a scale
Standard Deviation 10.94
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Smoking Status- Former
|
31.97 score on a scale
Standard Deviation 2.62
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Smoking Status- Current
|
39.55 score on a scale
Standard Deviation 4.37
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Age at Onset of CD Diagnosis- At or Below 16 Years
|
30.11 score on a scale
Standard Deviation NA
SD was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Age at Onset of CD Diagnosis- Between 17 and 40 Years
|
36.73 score on a scale
Standard Deviation 8.55
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Age at Onset of CD Diagnosis- Above 40 Years
|
43.16 score on a scale
Standard Deviation 7.43
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Location 1- Terminal Ileum
|
34.08 score on a scale
Standard Deviation 13.03
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Location 1 + 4- Terminal Ileum + Upper Gastrointestinal
|
33.45 score on a scale
Standard Deviation NA
SD was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Location 2- Colon
|
46.18 score on a scale
Standard Deviation 4.86
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Location 3- Ileocolon
|
39.58 score on a scale
Standard Deviation 4.32
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Location 3 + 4- Ileocolon + Upper Gastrointestinal
|
31.89 score on a scale
Standard Deviation 2.52
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Behavior- Nonstricturing, Nonpenetrating + Perianal
|
39.35 score on a scale
Standard Deviation 7.19
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Behavior- Stricturing + Perianal
|
34.05 score on a scale
Standard Deviation 11.26
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Disease Behavior- Penetrating + Perianal
|
42.51 score on a scale
Standard Deviation 2.35
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Presence of any Extraintestinal Manifestation of CD- Yes
|
38.80 score on a scale
Standard Deviation 2.74
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Presence of any Extraintestinal Manifestation of CD- No
|
37.88 score on a scale
Standard Deviation 9.12
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With High Intersphincteric Type- Yes
|
37.64 score on a scale
Standard Deviation 4.63
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With High Intersphincteric Type- No
|
38.09 score on a scale
Standard Deviation 9.36
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With High Transsphincteric Type- Yes
|
37.23 score on a scale
Standard Deviation 6.16
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With High Transsphincteric Type- No
|
38.20 score on a scale
Standard Deviation 9.19
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Suprasphincteric Type- Yes
|
45.46 score on a scale
Standard Deviation 6.53
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Suprasphincteric Type- No
|
36.85 score on a scale
Standard Deviation 8.35
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Extrasphincteric Type- Yes
|
40.71 score on a scale
Standard Deviation 9.96
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Extrasphincteric Type- No
|
37.58 score on a scale
Standard Deviation 8.62
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Superficial Type- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Low Intersphincteric Type- Yes
|
40.10 score on a scale
Standard Deviation 14.47
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Low Intersphincteric Type- No
|
37.68 score on a scale
Standard Deviation 8.11
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Low Transsphincteric Type- Yes
|
38.15 score on a scale
Standard Deviation 5.38
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Low Transsphincteric Type- No
|
37.96 score on a scale
Standard Deviation 9.29
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Midline Position- Yes
|
39.59 score on a scale
Standard Deviation 7.05
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Midline Position- No
|
33.63 score on a scale
Standard Deviation 11.63
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Lateral Position- Yes
|
36.33 score on a scale
Standard Deviation 9.95
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Lateral Position- No
|
39.12 score on a scale
Standard Deviation 7.78
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Seton- Yes
|
36.36 score on a scale
Standard Deviation 9.36
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Fistula With Seton- No
|
39.87 score on a scale
Standard Deviation 7.63
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: HBI Category- Remission
|
37.15 score on a scale
Standard Deviation 8.66
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: HBI Category- Mild Activity
|
45.40 score on a scale
Standard Deviation 6.60
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: HBI Category- Moderate Activity
|
33.45 score on a scale
Standard Deviation NA
SD was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Treatment-naïve- Yes
|
36.47 score on a scale
Standard Deviation NA
SD was not estimable due to low number of participants with event.
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Treatment-naïve- No
|
38.11 score on a scale
Standard Deviation 8.79
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery-naïve- Yes
|
39.30 score on a scale
Standard Deviation 7.45
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery-naïve- No
|
37.68 score on a scale
Standard Deviation 9.00
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Fistulotomy- Yes
|
31.97 score on a scale
Standard Deviation 2.62
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Fistulotomy- No
|
38.93 score on a scale
Standard Deviation 8.74
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Advancement Flap- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - LIFT- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Fibrin Glue- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Anal Fistula Plug- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Defunctioning Stoma- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Cutting Seton- No
|
38.00 score on a scale
Standard Deviation 8.48
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Loose Seton- Yes
|
39.81 score on a scale
Standard Deviation 9.46
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Loose Seton- No
|
35.28 score on a scale
Standard Deviation 6.60
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Other- Yes
|
46.80 score on a scale
Standard Deviation 3.98
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Surgery - Other- No
|
34.80 score on a scale
Standard Deviation 7.34
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Presence of Perianal Abscess- Yes
|
35.59 score on a scale
Standard Deviation 10.91
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Presence of Perianal Abscess- No
|
39.61 score on a scale
Standard Deviation 6.65
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
MCS-12: Presence of Anorectal Stricture- No
|
38.00 score on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, Perianal Disease Activity Index (PDAI) score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
|
|---|---|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Age
|
-0.072 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: BMI
|
0.210 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit
|
-0.014 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Total Number of CPFs per Participant
|
-0.270 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Time Since Seton Placement
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-0.185 correlation coefficient
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit
|
0.071 correlation coefficient
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: PDAI Score
|
-0.707 correlation coefficient
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS - 12: Number of Internal Fistula Openings per Participant
|
-0.450 correlation coefficient
|
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Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Number of External Fistula Openings per Participant
|
-0.442 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: SIBDQ Score
|
0.525 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: SQoL-M Score
|
0.690 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: SQoL-F Score
|
0.046 correlation coefficient
|
|
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
PCS- 12: Wexner Score
|
-0.259 correlation coefficient
|
SECONDARY outcome
Timeframe: At inclusion visit (Day 1)Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, PDAI score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients.
Outcome measures
| Measure |
CD Participants With CPF
n=15 Participants
Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.
|
|---|---|
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Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Age
|
0.484 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: BMI
|
0.022 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit
|
-0.132 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Total Number of CPFs per Participant
|
0.077 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Time Since Seton Placement
|
-0.323 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit
|
-0.018 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: PDAI Score
|
0.067 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Number of Internal Fistula Openings per Participant
|
-0.207 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Number of External Fistula Openings per Participant
|
-0.048 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: SIBDQ Score
|
0.404 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: SQoL-M Score
|
0.266 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: SQoL-F Score
|
0.039 correlation coefficient
|
|
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
MCS- 12: Wexner Score
|
-0.182 correlation coefficient
|
Adverse Events
CD Participants With CPF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER