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

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.