A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

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• Crohn Disease 1,880
• Rectal Fistula 189
• Fistula 731

Keywords

• Drug Therapy

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.

This study's enrollment of 15 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Study population

Groups and cohorts

• 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.

Primary outcomes

1. Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]

   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.

   Time frame: At inclusion visit (Day 1)

2. Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])

   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.

   Time frame: At inclusion visit (Day 1)

Secondary outcomes

1. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

   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.

   Time frame: At inclusion visit (Day 1)

2. Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants

   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.

   Time frame: At inclusion visit (Day 1)

3. Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants

   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.

   Time frame: At inclusion visit (Day 1)

4. Fecal Incontinence as Assessed by Wexner Score

   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.

   Time frame: At inclusion visit (Day 1)

5. Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score

   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.

   Time frame: At inclusion visit (Day 1)

6. Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years

   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.

   Time frame: Up to 3 years prior to the inclusion visit at Day 1

7. Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics

   Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI).

   Time frame: At inclusion visit (Day 1)

8. Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics

   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.

   Time frame: At inclusion visit (Day 1)

9. Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF

   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.

   Time frame: Up to 3 years prior to the inclusion visit at Day 1

10. Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables

    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.

    Time frame: At inclusion visit (Day 1)

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

    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.

    Time frame: At inclusion visit (Day 1)

12. Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables

    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.

    Time frame: At inclusion visit (Day 1)

13. Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables

    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.

    Time frame: At inclusion visit (Day 1)

Baseline characteristics

Related links

• Related Info ↗

Study documents

• Study protocol · Feb 25, 2021
• Statistical analysis plan · May 4, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Sap, Icf, Csr