World Journal of Colorectal Surgery
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1 World Journal of Colorectal Surgery Volume 6, Issue 1 Article 2 The Impact Of Fecal Incontinence And Disease Related Activity On Quality Of Life In Patients With Crohn s Disease Luke Neill Turner Osler Neil Hyman The University of Vermont, Burlington, Vermont, The United States of America, Luke.Neill@med.uvm.edu The University of Vermont, Burlington, Vermont, The United States of America, turner.osler@med.uvm.edu The University of Chicago, Chicago, Illinois, The United States of America, nhyman@surgery.bsd.uchicago.edu Copyright c 2016 The Berkeley Electronic Press. All rights reserved.
2 The Impact Of Fecal Incontinence And Disease Related Activity On Quality Of Life In Patients With Crohn s Disease Luke Neill, Turner Osler, and Neil Hyman Abstract Abstract Background: Both fecal incontinence and disease related activity can markedly impair the quality of life in patients with Crohn s disease. The aim of this pilot study was to determine the relationship between fecal incontinence and disease related symptoms to the overall and disease specific quality of life. Methods: Consecutive outpatients with Crohn s disease were recruited between 7/1/13-9/30/13 by an independent investigator during visits to the Digestive Disease Center of the University of Vermont College of Medicine. Patient demographics and disease distribution and were recorded prospectively. The Crohn s Disease Activity Index (CDAI), Fecal Incontinence Severity Index (FISI), Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ), Short Form 12 (SF12), Female Sexual Function Index (FSFI), and International Index of Erectile Function (IIEF) were completed. A Pearson product-moment correlation coefficient measured the degree of linear dependence between FISI, CDAI and the four QOL measures. Results: 36 patients were recruited with a mean age of 39.9 years; 47.2% were males. Mean CDAI was 156 and FISI FISI was inversely related to the SF-12 (p=.01) and SIBDQ (p<.001). No correlation was observed with the IIEF or FSFI. A similar inverse relationship was observed between the CDAI and quality of life measures (SF-12, p<0.001, SIBDQ-p<0.001, FSFI- p=.71, IIEF- p=0.47). Conclusion: Both fecal incontinence and disease related activity impair the quality of life of patients with Crohn s disease in a linear manner. Surprisingly, both male and female sexual function appeared largely unaffected by these symptoms. KEYWORDS: Crohn s disease, quality of life, Crohn s disease activity index, fecal incontinence
3 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 1 Introduction Crohn s disease (CD) is estimated to affect between 400,000 and 600,000 people in North America 1. Although CD can occur in all age groups, the disease commonly affects young patients, with a bimodal peak observed at 20 and 50 years of age 2. Patients may suffer from chronic diarrhea, perianal manifestations and fecal incontinence, which can be devastating to quality of life (QOL), over and beyond the symptoms that may be more directly attributable to disease related activity. As such, key management goals include both inhibition of the inflammatory response as well as the control of burdensome symptoms. A wide variety of instruments have been developed over the years in an attempt to objectively capture both disease related symptoms as well as the impact on patient quality of life. Applying the broad array of validated assessment tools that may apply to patients with Crohn s disease is unlikely to be feasible in routine clinical practice. Certainly, it is reasonable to presume that optimal management of disease related activity will be associated with good control of symptoms and enhanced quality of life. However, these relationships are often complex and may be challenging to discern in individual patients across the spectrum of disease manifestations that may be encountered. For example, patients with perianal Crohn s disease may face particular challenges with fecal incontinence and/or sexual intimacy. The Crohn s Disease Activity Index (CDAI) is a useful tool for quantifying symptoms and is commonly used to assess response to medications. The Fecal Incontinence Severity Index (FISI) is a validated instrument used to grade the nature and extent of fecal incontinence 3, 4. It is unknown whether the CDAI or specific symptoms such as fecal incontinence are more important drivers of an impaired quality of life. We aimed to assess the feasibility of comprehensively measuring the impact of fecal incontinence and disease related activity on the disease specific and global quality of life instruments in patients with Crohn s disease, by applying a broad array of validated instruments. We hypothesized that CDAI and FISI would exhibit a linear inverse correlation with all five QOL tools used in this study. Methods Study Design This was a cross-sectional, observational study conducted at Fletcher Allen Health Produced by The Berkeley Electronic Press,
4 2 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art. 2 Care, the teaching hospital of the University Of Vermont College Of Medicine. Consecutive CD patients who had routine follow up clinic appointments scheduled from July 1 through September 30 th, 2013 with one of the surgeons or gastroenterologists in the Digestive Disease Center were offered participation in the study. Patients who were seen in follow up of a recent hospitalization or surgery, or who were being seen for an acute disease exacerbation were not offered participation. We aimed to avoid the confounding effects of disease related medical crises (e.g. an acute abscess, recovery from major surgery) on quality of life and focus on the cohort receiving routine care; we hoped this would provide a better representation of the impact of symptoms on quality of life under usual day to day conditions. Subjects were made aware of the study by the clinician at the time of their on-site visit and enrolled through an on-site interview by an independent researcher who had not otherwise been involved in their care. This time period was chosen based on the availability of a single medical student (LN) who could always be accessed over a defined research fellowship to ensure standardization across the consecutively accrued cohort and minimize bias. Patients were interviewed in a separate, private room at the time of their clinic visit to complete the questionnaires. Demographic information and disease distribution was obtained from a prospectively maintained quality database. The patient s disease distribution was categorized based on site(s) of major clinical involvement and was classified as small bowel disease, ileocolic disease, large bowel disease and perianal disease. For example, if a patient with multiple anal fistulas had only microscopic involvement of the large bowel without problematic diarrhea, abdominal pain or bleeding, the site would be classified as perianal disease. The study protocol was approved by the Institutional Review Board at the University of Vermont. QOL Four validated QOL tools were chosen owing to their relevance to disease specific and overall quality of life in patients with Crohn s disease: The Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ), the Medical Outcomes Study Short Form 12 Version 2 (SF-12), the Female Sexual Function Index (FSFI), and the International Index of Erectile Function (IIEF). The results from these assessment tools were correlated to the scores obtained from the CDAI and FISI
5 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 3 Crohn s Disease Activity Index The Crohn s Disease Activity Index is a tool used to quantify symptoms in CD patients 5. The CDAI consists of 8 factors: number of liquid stools each day for seven days, abdominal pain, general well-being, presence of complications, use of lomotil or opiates for diarrhea, presence of abdominal mass, hematocrit of <0.47 in men and <0.42 in women, and the percentage deviation from standard weight. Each factor is tabulated after weighting multipliers are incorporated 5, 6. Fecal Incontinence Severity Index The Fecal Incontinence Severity Index is used to assess the severity of fecal incontinence. The FISI records leakage of gas, mucus, liquid, and solid stool and multiplies them by one of five frequencies: one to three times per month, once per week, twice per week, once per day, and twice per day. Each of the four types of incontinence receives a severity score ranging from 1-20 with a higher score equaling more severe symptoms. The four scores are then added to obtain the total FISI score 3, 4. Short Quality of Life in Inflammatory Bowel Disease Questionnaire The SIBDQ is a disease specific questionnaire used to measure the health related quality of life (HRQOL) of patients with Inflammatory Bowel Disease (IBD). It contains 10 questions and scores on the SIBDQ range from 1 to 7 with a higher score representative of a better QOL. SIBDQ is validated and shortened version of the more detailed Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) 7, 8. Medical Outcomes Study Short Form 12 The SF-12 is a shortened, more practical version of the 36-item Short Form Health Survey (SF-36). The SF-12 measures HRQOL in 8 areas of lifestyle including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health 9, 10. In this study, scores from the SF-12 were reported as a Physical Component Summary (PCS) and a Mental Component Summary (MCS). Produced by The Berkeley Electronic Press,
6 4 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art. 2 Female Sexual Function Index The FSFI is a questionnaire that measures sexual functioning in women by specifically assessing 6 domains of sexual functioning including desire, subjective arousal, lubrication, orgasm, satisfaction, and pain 11. The FISI consists of 19 questions and ranges from a score of 2-36 with a higher score representing better sexual function. International Index of Erectile Function The IIEF is a 15 item questionnaire that measures erectile functioning through the five male sexual domains of erectile, function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction 12. The IIEF score can range from 2-75 with a higher number representative of better sexual function. Statistical Analysis Descriptive statistics include means and standard deviations for continuous variables and frequencies for qualitative variables were performed. A Pearson product-moment correlation coefficient was used to measure the degree of linear dependence between FISI, CDAI and the four QOL measures. A chi square test was used to compare the FSFI and IIEF of the patients with perianal disease to those without perianal involvement. Results Patient Enrollment and Characteristics During the study period, 37 patients with CD who had scheduled follow up appointments were invited to enroll in the study. Out of the 37 patients, one chose not to participate (97.2% participation rate). Out of the 36 patients who enrolled, 23 were being seen by a gastroenterologist and 13 were being seen by a surgeon. The mean age was 39.9 years and the sex distribution was 47.2% male and 52.8% female. The median duration of disease in study patients was 13.6 years with a range of 1-34 years. The primary distribution of disease included 8 (22%) patients with small bowel involvement alone, 2 (6%) patients with large bowel involvement alone, 16 (44%) patients with both small and large bowel involvement, and 10
7 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 5 (28%) patients with perianal Crohn s disease. Health-related and disease-specific QOL scores are presented in Table 1. CDAI and FISI were strongly correlated with the SF-12 and SIBDQ indices, but not with the FSFI or IIEF scores (Table 2, Figures 1-3). As demonstrated in Table 3, those patients with perianal disease did not fare worse that those without perianal involvement in any of the subcategories of the two sexual function indices, with the exception of the pain subscale in the FSFI. Discussion We observed a 97% compliance rate for completion of an extensive array of validated assessment tools that measure both symptoms and quality of life in a relatively stable cohort of medical and surgical patients with Crohn s disease. It was not at all clear to us that this extent of patient reported quality of life assessment would be feasible and accepted by our patients. It is reassuring that this comprehensive profile of patient reported outcomes can be accomplished in the research setting and may be used going forward to truly understand the impact of various symptoms, disease related manifestations and interventions on disease related and overall quality of life. This study also sought to establish the relationship between disease related symptoms, as measured by the CDAI, and fecal incontinence, as measured by FISI, and quality of life in a relatively stable cohort of patients with Crohn s disease. Although it was hypothesized that CDAI and FISI would have an inverse relationship with all five QOL metrics, there was no relationship observed with the two sexual assessment tools. We found that both FISI and the CDAI share a negative linear relationship with the SF-12 (MCS and PCS), and SIBDQ, suggesting that both fecal incontinence and disease related activity significantly impair the quality of life of patients with Crohn s disease to a similar extent. However, no significant correlation was shown between the CDAI and the IIEF or FSFI. Although a disease severity index such as CDAI or FISI can quantify the extent of symptoms, they are not designed to measure the impact that these symptoms have on a patient s quality of life. Indeed, concern has been raised about the CDAI s lack of subjective QOL measures and the IBDQ was developed as a means to help provide elements of social, systemic, and emotional symptoms into an activity Produced by The Berkeley Electronic Press,
8 6 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art. 2 index 13. Similarly, the Fecal Incontinence Quality of Life (FIQL) was created to measure the impact of fecal incontinence on quality of life 3. A limited number of studies have sought to correlate CDAI scores with other subjective QOL tools. Schirbel found a strong correlation between SIBDQ and the CDAI (p=0.0001) 14. Gibson utilized the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Assessment of Quality of Life (AQoL) multiattribute utility instrument and correlated them with the CDAI. A negative correlation between disease severity and both IBDQ and AQoL was demonstrated 15. Using a HRQOL tool (EuroQol EQ-5D), Konig also found a strong correlation between the CDAI and quality of life (rho= -0.65, p<0.001) 16 and Zhou showed that IBD patients with active disease had significantly lower scores for all eight dimensions of the SF-36 compared to those in remission (p<0.01) 17. Further support for the relationship between disease related activity and quality of life exists in the pediatric population; a strong correlation has been described between HRQOL (Visual Analog Score) and the Short Pediatric Crohn s Disease Activity Index (rho=0.65, P < 0.001) 18. Similarly, in the Canadian Crohn s Relapse Prevention Trial, a clear direct relationship was found between IBDQ scores and CDAI using a sample of three hundred and five patients with stable Crohn s disease (r= -0.67, P< ) 13. This study sought to examine how the CDAI score and FISI correlate to other domains of a patient s quality of life. Our data suggests that the inverse relationship between CDAI, FISI and the QOL measures is linear, implying that there is no safe cushion only after which quality of life begins to become impaired. In a study assessing the impact of fistulotomy on continence and quality of life, quality of life detriment was only encountered once the FISI exceeded a specific threshold 19. Our data suggests that any increase in the severity scales has consequences and supports therapeutic interventions to decrease both the FISI and CDAI as much as possible in patients with Crohn s disease, rather than aim for a particular target. The correlation between CDAI and FISI is not surprising, since more active disease is commonly associated with loose stools, which may in turn create challenges for patients with fecal incontinence. However, it is noteworthy that in this cohort of patients with Crohn s disease, mean FISI was 20.8 and median FISI was 24.2; only 5 patients had a FISI of 0. This demonstrates that some degree of fecal incontinence is relatively ubiquitous in patients with Crohn s disease. In this context, it can be challenging to tease out the relative contribution of fecal incontinence and disease related activity to the impairment in quality of life measures.
9 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 7 Surprisingly, there was no demonstrable impact of either disease severity or the extent of fecal incontinence on sexual function in this relatively young cohort. In patients with rheumatoid arthritis, studies have demonstrated a higher sexual dysfunction rate for affected patients when compared to controls using the FSFI 20, 21. However our study found no correlation was seen between the CDAI or FISI and the IIEF or FSFI, which measure male and female sexual function respectively. Various aspects of sexual experience including drive, performance and enjoyment are included in these validated tools. We expected that all of these components would potentially be adversely affected by incontinence and increasing disease related symptomatology. Interestingly, Timmer found that mood disturbances and social environment had a stronger impact on female sexual function than disease specific factors 22. We were also surprised that there was no significant correlation between distribution of disease and sexual function. Specifically, we expected that patients with perianal disease would have particular problems with various aspects of sexual performance and enjoyment. However, the pain dimension in the FSFI Index was the only aspect of male and female sexual function that differed in Crohn s disease patients with and without perianal disease. We had hypothesized that patients with perianal disease would suffer sexual dysfunction to a greater extent when compared to those with CD limited to the small or large bowel. In an assessment of sexual function and quality of life after surgical treatment of anal fistulas in perianal CD, it was shown that the median FSFI and IIEF score were not significantly different between perianal patients with no surgical treatment and those with surgical treatment for anal fistulas 23. Limitations of this study include a small sample size, although it must be noted that asking patients to fill out such an exhaustive array of questionnaires is not without its challenges. We were pleased that 36/37 of patients agreed to participate, but it is unclear whether they would be willing to do so outside of the setting of a research initiative..a larger sample size than we accrued in this pilot study would provide for greater statistical power and enable finer distinctions between the groups and indices. Having the same, independent researcher administer the assessment tools provided standardization and a resource to help clear up ambiguities. But it is always possible that subjects were embarrassed to provide truthful responses to all of the questions in person, especially since many of the questions were quite personal or even intimate in nature. Further, we intentionally chose patients who were not being seen for acute symptoms, which may limit the generalizability of our data to patients who are in the midst of disease exacerbation or experiencing an acute complication of Crohn s disease. Produced by The Berkeley Electronic Press,
10 8 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art. 2 In summary, we found that both CDAI and FISI correlated strongly with overall and several disease specific quality of life measures in a relatively stable cohort of patients with Crohn s disease. The linear relationship observed without a safe threshold below which quality of life is unaffected, supports an aggressive strategy to reduce disease related activity and symptoms as aggressively as possible. On the other hand, neither male nor female sexual functions appeared to be negatively impacted by a higher score on the CDAI or FISI, and patients with stable perianal disease did not seem to fare worse on these measures. These findings challenged our assumptions about factors that impair sexual function in patients with Crohn s disease. Larger, multicenter studies are warranted to confirm these findings. References 1. Loftus EV, Jr., Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther 2002;16: Polito JM, 2nd, Childs B, Mellits ED, et al. Crohn's disease: influence of age at diagnosis on site and clinical type of disease. Gastroenterology 1996;111: Rockwood TH, Church JM, Fleshman JW, et al. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000;43:9-16; discussion Rockwood TH, Church JM, Fleshman JW, et al. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum 1999;42: Best WR, Becktel JM, Singleton JW, et al. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976;70: Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet 1980;1: Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989;96: Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol 1996;91:
11 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 9 9. Ware J, Jr., Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34: Gandek B, Ware JE, Aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998;51: Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000;26: Rosen RC, Riley A, Wagner G, et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49: Irvine EJ, Feagan B, Rochon J, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Gastroenterology 1994;106: Schirbel A, Reichert A, Roll S, et al. Impact of pain on health-related quality of life in patients with inflammatory bowel disease. World J Gastroenterol 2010;16: Gibson PR, Weston AR, Shann A, et al. Relationship between disease severity, quality of life and health-care resource use in a cross-section of Australian patients with Crohn's disease. J Gastroenterol Hepatol 2007;22: Konig HH, Ulshofer A, Gregor M, et al. Validation of the EuroQol questionnaire in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2002;14: Zhou Y, Ren W, Irvine EJ, et al. Assessing health-related quality of life in patients with inflammatory bowel disease in Zhejiang, China. J Clin Nurs 2010;19: Teitelbaum JE, Rajaraman RR, Jaeger J, et al. Correlation of health-related quality of life in children with inflammatory bowel disease, their parents, and physician as measured by a visual analog scale. J Pediatr Gastroenterol Nutr 2013;57: Cavanaugh M, Hyman N, Osler T. Fecal incontinence severity index after fistulotomy: a predictor of quality of life. Dis Colon Rectum 2002;45: Coskun B, Coskun BN, Atis G, et al. Evaluation of sexual function in women with rheumatoid arthritis. Urol J 2013;10: Aras H, Aras B, Icagasioglu A, et al. Sexual dysfunction in women with rheumatoid arthritis. Med Glas (Zenica) 2013;10: Produced by The Berkeley Electronic Press,
12 10 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art Timmer A, Kemptner D, Bauer A, et al. Determinants of female sexual function in inflammatory bowel disease: a survey based cross-sectional analysis. BMC Gastroenterol 2008;8: Riss S, Schwameis K, Mittlbock M, et al. Sexual function and quality of life after surgical treatment for anal fistulas in Crohn's disease. Tech Coloproctol 2013;17: Table 1. Patient characteristics, health-related and disease-specific quality of life scores. CD Patients (n=36) Age, mean (SD) 39.9(15.9) Male, n (%) 17(47.2) QOL Scores CDAI Scores Mean(SD) 156.1(123.2) Median SF 12 Scores PCS Mean(SD) 46.5(11.6) Median MCS Mean(SD) 49.3(8.8) Median SIBDQ Scores Mean(SD) 4.8(1.4) Median 5.10 FISI Scores Mean(SD) 20.4(17.9) Median Range 19(61) IIEF Scores Mean(SD) 42.6(26.1)
13 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 11 Table 2. Pearson correlation coefficients between CDAI, FISI, and health-related and disease-specific quality of life scores. CDAI Pearson Correlation FISI SF 12 (PCS) 0.71(p=0.00) 0.44(p=0.01) SF 12 (MCS) 0.54(p=0.00) 0.43(p=0.01) SIBDQ Scores 0.79(p=0.00) 0.53(p=0.00) IIEF Scores 0.19(p=.47) +0.08(p=0.76) FSFI Scores 0.10(p=.71) (p=0.83) Table 3. The impact of perianal Crohn s disease on male and female sexual function. Sexual function comparison between patients with and without perianal disease IIEF Erectile Function p=0.40 Orgasmic Function p=0.65 Sexual Desire p=0.60 Intercourse Satisfaction p=0.77 Overall Satisfaction p=0.38 FSFI Desire Arousal Lubrication Orgasm Satisfaction Pain p=0.53 p=0.44 p=0.69 p=0.16 p=0.34 p=0.04 Produced by The Berkeley Electronic Press,
14 12 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art. 2 Figure 1. 1A. Correlation between SIBDQ and CDAI in patients with Crohn s disease (n=36). Correlation coefficient (Pearson s) (rho) -0.79, p=0.00 1B. Correlation between SIBDQ and FISI in patients with Crohn s Disease (n=36). Correlation coefficient (Pearson s) (rho) -0.53, p=0.00
15 Neill et al.: The Impact Of Fecal Incontinence And Disease Related Activity On 13 Figure 2. 2A. Correlation between FSFI and CDAI in patients with Crohn s disease (n=36). Correlation coefficient (Pearson s) (rho) -0.10, p=0.71 2B. Correlation between FSFI and FISI in patients with Crohn s Disease (n=36). Correlation coefficient (Pearson s) (rho) +0.06, p=0.83 Figure 3. Produced by The Berkeley Electronic Press,
16 14 World Journal of Colorectal Surgery Vol. 6, Iss. 1 [], Art. 2 3A. Correlation between IIEF and CDAI in patients with Crohn s disease (n=36). Correlation coefficient (Pearson s) (rho) -0.19, p=0.47 3B. Correlation between IIEF and FISI in patients with Crohn s Disease (n=36). Correlation coefficient (Pearson s) (rho) +0.08, p=0.76
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