Introduction
Given the psychological, social, and functional impacts that fecal incontinence (FI) has on an indi- vidual, the assessment of health-related quality of life (HRQoL) is an important consideration when evalu- ating the efficacy of treatment. An individual with FI faces a serious set of challenges in living life, and as a result, providers are also faced with consideration of these issues in providing treatment. For example, the implantation of an artificial sphincter is about more than technical procedures; it is also about its impact on the individual’s ability to live life.
The role of HRQoL continues to grow, and accom- panying this growth is an increase in research in the refinement of the assessment of HRQoL. HRQoL assessment in FI is still relatively new, and the process of specifying the range of issues involved as well as the content of many of the areas identified to date is ongoing. This work continues to improve the understanding and knowledge of FI and expands horizons. The following material focuses on two issues associated with HRQoL assessment and FI.
First is a brief review of different measures that are available to assess HRQoL for FI. This is followed by a consideration of issues that are associated with evaluating instruments for use in assessment of HRQoL and the development of HRQoL instruments.
Existing Measures for Quality of Life in Fecal Incontinence
The state of HRQoL measurement in FI is still devel- oping and evolving. A number of reviews of issues associated with and instruments available for meas- uring HRQoL in FI are available [1–3]. What is apparent from the research is that it is possible to assess HRQoL in FI with success, but the field has by no means matured.
There are three basic instrument types available for the study of HRQoL in FI: (1) general HRQoL instruments, (2) specialized instruments, and (3)
condition-specific measures. Each instrument sig- nals a different approach and presents unique strengths as well as associated weaknesses.
Instruments such as the SF-36 [4] and European Quality of Life (EuroQol) [5] have been used with suc- cess in numerous studies on FI. The primary concern with the use of general HRQoL instruments is the sen- sitivity of the instrument to specific issues associated with FI as well as the presence of floor and ceiling effects. While mixed, the findings are encouraging.
For example, the new version of the SF-36 (v 2.0) appears to demonstrate increased sensitivity to HRQoL in FI compared with the original SF-36 [6]. At a minimum, these instruments can serve as gross indicators of HRQoL in the FI population and provide the opportunity to compare within as well as between populations [e.g., urinary incontinence (UI) vs. FI].
This ability to compare across populations does come with a price–a question about responsiveness exists: Are the instruments sensitive enough to be able to detect change that is meaningful in the FI population? This issue is compounded with the potential for floor effects emerging. When floor effects are present, there is only one direction for possible change to occur: towards improvement. As a result, the measures can lead to a false conclusion-an overestimation of benefit instead? Finally, when con- sidering these measures, the specification of the treatment outcome needs to be determined. Treat- ment is often directed and specific, and thus gross measures, such as general HRQoL instruments, might not be able to detect meaningful changes rela- tive to intended outcomes.
Specialized Measures
Specialized scales exist for an incredibly large range of issues [7, 8], and research on QoL in FI could ben- efit from their utilization in many instances. These measures represent an underutilized area of HRQoL assessment in FI. This underutilization detracts from our ability to further the understanding of HRQoL in
Impact of Fecal Incontinence on Quality of Life
Todd H. Rockwood
6
FI. If a treatment, surgical or otherwise, is likely to be strongly related to a specific aspect of HRQoL–e.g., stress/anxiety, depression, control–then selection of specialized instruments that measure that domain would best serve patients, providers, and researchers.
Condition-specific QoL (CSQoL) measures are generally designed based on a model of disease/con- dition causing change to some other construct, e.g., FI causes changes in the amount or intensity of anxi- ety experienced by an individual. This assumption is viable, and instruments such as the FIQoL scale make the assumption that FI causes anxiety and the intent is to assess anxiety solely associated with FI.
The above model is generally adequate for most outcomes research, but it cannot be assumed to be adequate for all research, nor is it adequate in the long run. An example of this can actually be found in the evaluation of instruments such as the FIQoL in the postpartum population. This work consistently points out that the assessment of core issues such as shame, embarrassment, and stress are not complete- ly adequate [9, 10]. This is due, in part, to the com- bined presence of FI, the event of childbirth and a newborn, and all the interactions that are not cap- tured with general HRQoL or CSQoL instruments.
The use of specialized scales in these instances would provide a more robust assessment and increase our ability to evaluate the relativistic impacts of the dif- ferent conditions.
Evaluation of specific treatments, such as biofeed- back, could benefit greatly from the use of specialized measures. Depression can be used as an example to illustrate this benefit. Biofeedback targets control, and depression is often a response to lack of control.
If biofeedback creates a sense of control, then as a sec- ondary effect, biofeedback could impact depression.
Instruments designed specifically around depression, such as the Beck Depression Inventory [7] or the Cen- ter for Epidemiologic Studies Depression (CESD) scale [7] would be more sensitive and likely to identi- fy and assess such secondary impacts. Evaluation of these secondary impacts would allow us to begin to unravel an as of yet unanswered question: How much does FI contribute to the emergence and manifesta- tion of depression? Specialized scales would allow us to begin to untangle these types of questions by start- ing with depression and looking at how FI changes it as opposed to the current approach in which we eval- uate depression associated with FI. This knowledge could then be used to refine CSQoL instruments.
Condition-specific Measures for Fecal Incontinence
Recent work on CSQoL measures in FI is encourag- ing. This work is directed at three key issues: (1) eval-
uating the content of existing measures and pointing out shortcomings, (2) comparing different measures against each other to identify relative strengths and weaknesses, and (3) developing new instruments or refining the content of existing instruments in gener- al or for application in specific populations.
Three instruments have dominated measurement of HRQoL in FI. The Gastrointestinal Quality of Life Index (GIQLI) [11], the Manchester Health Question- naire [12], and the FIQL scale [13]. Each of these instruments has been used successfully in the assess- ment of QoL associated with treatment for with FI. A number of other instruments have also been devel- oped, but their utilization has not been as wide spread. This is in part due to the very specific nature of the instrument, e.g., QoL in a Parkinson’s disease population [14], clinical/community epidemiology [15, 16], or children [17].
An encouraging trend in QoL measurement in FI is work that is building upon these base instruments.
For example, the sensitive and personal nature of FI underscores the importance of how instruments are administered. Kwon and colleagues have done work to adapt the Manchester Health Questionnaire for telephone administration [18]. Although the results are not definitive, this does represent a critical step [19].
Another encouraging area is work that points out the shortcomings in these base tools, both conceptu- ally and in terms of measurement. For example, work has demonstrated the need to expand the con- tent of the FIQoL to better capture the postpartum mother’s experiences [9, 10]. Work such as this is absolutely critical to improving our ability to meas- ure QoL in FI.
Also underway is work that assesses QoL more systemically. The GIQLI is the forerunner of work in this area. It looks at FI within the context of the over- all GI system. There are distinct benefits to such instruments in that they focus on interrelated aspects of the body so that, for example, function and effects due to X [irritable bowel syndrome (IBS)] are not as likely to be attributed to Y (FI). Recently, there has been an increase of work focusing on measurement associated with the pelvic floor and FI. Measures in this area have a significant contribution to make. FI is often associated with issues beyond the sphincter, e.g., the pelvic floor, and as a result, its occurrence cannot be disassociated from conditions such as UI.
Instruments such as the FIQoL might not be able to
disentangle QoL issues when both UI and FI are pres-
ent [9, 20, 21]. Instruments focusing on the pelvic
floor would be appropriate when the root cause of FI
is due to the pelvic floor but not appropriate for use
when FI is due to something other than the pelvic
floor (e.g., sphincter tear).
Health-related Quality of Life and Fecal Incontinence
The following material focuses on central issues in the consideration of what instrument(s) to use as well as the development or refinement of existing instruments. The primary question/issue is to deter- mine what is meant by HRQoL relative to the pur- pose of the research. Core to this is an assessment of the primary and secondary impacts of treatment.
HRQoL can range from observable characteristics (functional status) to abstract constructs that are not directly observable (depression). Phenomena in the latter instance are not straightforward when it comes to conceptualization and measurement.
The notion of stress provides a good illustration of the complexities associated with identifying or devel- oping appropriate measures. Stress is a core issue associated with HRQoL and FI, and the conceptual orientation employed relative to stress can determine both its meaning and how it is measured. Stress can be conceptualized as event based or, alternatively, as an internal coping phenomenon. In the event-based model, stress is conceived of as an individual’s response to events. An individual has an FI episode, and this event causes stress. Stress is the result of the event occurring; had the event not occurred, stress would not be induced. Such a model is embedded within much of the work in FI. The relativistic impact of solid versus liquid stool loss events is an illustra- tive example of such an approach. Alternatively, the coping model does not focus on events that occur or environmental conditions; rather, the focus is the individual’s perception of their ability to deal with a stress. In these instances, whether or not a stool loss event has occurred is not particularly relevant. It is the individual’s felt ability to cope with the event that is important.
Consideration of scope is an oft-ignored issue in the use HRQoL measures. Returning to the above example of stress, consider two alternative studies: In a surgical treatment of FI in which an artificial sphincter is implanted, the focus on outcomes might use a stress-events model. The intent of the artificial sphincter is to reduce the number of events experi- enced. Given this, in the assessment of HRQoL, logic would argue that treatment reduces events and reduction in events reduces stress. Alternatively, if the research is focused on psychosocial interventions (e.g., counseling to deal with postpartum FI), then a different logic is employed; treatment increases abil- ity to deal with FI occurring, and increased ability to deal with FI reduces stress associated with FI. Recog- nizing this distinction is important for both instru- ment development as well as choosing between exist- ing instruments when conducting studies. Concor-
dance between treatment outcomes and what is being measured is essential to conducting good outcomes research.
HRQoL can range from macro measures associat- ed with existential well-being to micro measures around shame and embarrassment associated with FI. No single instrument can adequately represent the full scope of HRQoL; instruments tend to focus more or less on different aspects. This requires thought when selecting an appropriate instrument.
FI is not a condition that has a primary effect on cog- nitive abilities, but it does have a dramatic impact on daily activities that are usually taken for granted (e.g., shopping) or emotional and psychological con- ditions (e.g., shame). The intent of CSQoL measures such as the adapted Manchester Health Question- naire [12, 18] or the FIQoL [13] is to focus on issues that have high salience for FI. These instruments tend to focus toward the microlevel measures in the instrument and focus on the impact FI has on day-to- day activities and life. The instruments do not attempt to measure the impact that FI has on the meaning of life.
Another critical issue in FI research is targeting instruments for particular populations and/or situa- tions. FI research is dominated by work in one of two populations, geriatric or postpartum, with a smaller amount of work in cancer, trauma, and adolescent populations. HRQoL in general and CSQoL in partic- ular is not uniform across populations, and consider- ation of instrument needs to include an assessment of the population. Instruments such as the GIQLI and the FIQoL are designed for the general FI population, and the unique situations faced by populations such as the new mother or the institutionalized individual bring fundamental changes to the conceptualization of QoL. It is important that this aspect of scope be included in the consideration of measures. Instru- ments that adapt existing tools for use in specific populations, such as the Manchester Health Ques- tionnaire [12] or the work of Cockell et al. [10] for postpartum or Trajanovska and Catto-Smith in chil- dren [17], are central to expanding our knowledge and understanding of FI.
One fundamental issue that has yet to be success- fully dealt with in FI research is coping. To date, cop- ing behaviors and mechanisms have been treated in one of two ways in FI research. Figure 1a illustrates the initial treatment of coping in FI research. Coping is a response to severity and as a result is an indica- tor of the severity of the condition. The impact of this can mediate the impact severity has on HRQoL [22].
Alternatively, Figure 1 illustrates a more recent emer-
gence of the conceptualization of coping [3]. Coping
is related to severity as shown in the dashed line but
can be viewed as a response to severity or as a means
of reducing severity. Regardless, it has a direct rela- tionship to HRQoL that has not yet been adequately dealt with.
The final issue associated with conceptual issues has been discussed within the context of the above, but it is the purpose of the assessment of HRQoL. Is the assessment aimed at evaluating the outcome of a particular treatment, an epidemiological evaluation of a population, or general social research evaluating what FI means to life? To date, most instruments in FI research have been developed around the assess- ment of treatment and outcomes research. This means that instrument content is dominated by issues that should be either directly or indirectly affected by treatment. Moving forward, instruments need to evolve to reflect more of the individual’s experience with FI as well as to make the instruments more sensitive to evaluating treatment for FI.
Conclusions
FI is, as conditions go, an incredibly sensitive and difficult issue to deal with relative to QoL assessment.
Whereas the condition is not necessarily life threat- ening physically, it can be seen as life threatening for social and personal life. Because of this, it is impor- tant to assess QoL when treating or evaluating treat- ment for FI.
Research has shown that the basic tools are avail- able to assess HRQoL for individuals with FI and that this assessment is a vital part of the evaluation of treatment of FI. However, there is a need for addi- tional work on QoL measurement in FI to refine the understanding of basic issues, such as coping mech-
anisms, where they fit in relative to severity on the QoL spectrum, and whether they provide sufficient detail regarding shame and its role in QoL. Going for- ward, there are several factors that can make work in this area more successful and lead to more rapid development: first is a focus on the development of modules for specific populations that can be append- ed to existing instruments. Second is building upon the work that has been done to date and pushing it forward, such as the work on QoL postpartum. Final- ly is to start integrating the patient’s perspective into measures at a deeper level.
References
1. Baxter NN, Rothenberger DA, Lowry AC (2003) Mea- suring fecal incontinence. Dis Colon Rectum 46(12):1591–1605
2. Eton DT, Lepore SJ (2002) Prostate cancer and health- related quality of life: a review of the literature. Psy- chooncology 11(4):307–326
3. Rockwood TH (2004) Incontinence severity and QOL scales for fecal incontinence. Gastroenterology 126 (1 Suppl 1):S106–S113
4. Ware J et al (1993) SF-36 Health Survey: manual and interpretation guide. The Health Institute, New Eng- land Medical Center, Boston
5. Brazier J, Jones N, Kind P (1993) Testing the validity of the EuroQol and comparing it with the SF-36 Health Survey questionnaire. Qual Life Res 2:169–180 6. Bordeianou L et al (2006) Does incontinence severity
correlate with quality of life? American Society of Colon and Rectal Surgeons, Seattle, WA, June 2006 7. Robinson JP et al (1991) Measures of personality and
social psychological attitudes. In: Measures of social psychological attitudes, vol 1. Academic Press, San Diego
Fig. 1. Conceptualization of coping in fecal incontinence research. HRQoL health-related quality of life
8. McDowell I, Newell C (1996) Measuring health: a guide to rating scales and questionnaires, 2nd edn. Oxford University Press, New York
9. Hatem M, Fraser W, Lepire E (2005) Postpartum uri- nary and anal incontinence: a population-based study of quality of life of primiparous women in Quebec. J Obstet Gynaecol Can 27(7):682–688
10. Cockell SJ, Oates-Johnson T, Gilmour DT et al (2003) Postpartum flatal and Fecal Incontinence Quality-of- Life Scale: a disease- and population-specific measure.
Qual Health Res 13(8):1132–1144
11. Eypasch E, Williams JI, Wood-Dauphinee S et al (1995) Gastrointestinal Quality of Life Index: Develop- ment, validation and application of a new instrument.
Br J Surg 82:216–222
12. Bug GJ, Kiff ES, Hosker G (2001) A new condition-spe- cific health-related quality-of-life questionnaire for the assessment of women with anal incontinence.
BJOG 108(10):1057–1067
13. Rockwood TH, Church JM, Fleshman JW et al (2000) Fecal Incontinence Quality of Life Scale: quality-of-life instrument for patients with fecal incontinence. Dis Colon Rectum 43(1):9–16
14. Sakakibara R, Shinotoh H, Uchiyama T et al (2001) Questionnaire-based assessment of pelvic organ dys- function in Parkinson’s disease. Auton Neurosci 92(1–2):76–85
15. Bharucha AE, Locke GR 3rd, Seide BM, Zinsmeister
AR (2004) A new questionnaire for constipation and faecal incontinence. Aliment Pharmacol Ther 20(3):355–364
16. Bharucha AE, Zinsmeister AR, Locke GR et al (2006) Symptoms and quality of life in community women with fecal incontinence. Clin Gastroenterol Hepatol 4(8):1004–1009
17. Trajanovska M, Catto-Smith A-G (2005) Quality of life measures for fecal incontinence and their use in chil- dren. J Gastroenterol Hepatol 20(6):919–928
18. Kwon S, Visco AG, Fitzgerald MP et al (2005) Validity and reliability of the Modified Manchester Health Questionnaire in assessing patients with fecal inconti- nence. Dis Colon Rectum 48(2):323–331
19. Rockwood T (2005) Comment: validity and reliability of the Modified Manchester Health Questionnaire in assessing patients with fecal incontinence. Dis Colon Rectum 48(2):331–334
20. Barber MD, Walters MD, Bump RC (2005) Short forms of two condition-specific quality-of-life question- naires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 193(1):103–113 21. Kelly CE (2003) Which questionnaires should be used
in female urology practice? Curr Urol Rep 4(5):375–380
22. Jorge JM, Wexner SD (1993) Etiology and manage- ment of fecal incontinence. Dis Colon Rectum 36(1):77–97
