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Correlating the Fecal Incontinence Quality-of-Life Score and the SF-36 to a Proposed Ostomy Function Index in Patients with a Stoma
This article is based on a poster presented at the annual meeting of the American Society of Colon and Rectal Surgeons, Chicago, Ill, June 3-8, 2003.
According to studies by McLeod et al1 and Nugent et al, 2 who assessed the results of almost 1,000 patients by questionnaire, as well as the reviews of the literature by other authors,3-5 quality of life is negatively affected by the creation of an ostomy. Ostomy function, which includes leakage, frequency of emptying and changing, difficulty in changing, duration of change, assistance required, and the impact on lifestyle, does not appear to be uniform from patient to patient. Studies of quality of life in persons with ostomies performed to date often fail to consider this factor.
Lack of consideration of ostomy function may lead to inappropriate conclusions that do not apply to patients with ostomies in general, well-functioning ostomies, or poorly functioning ostomies. Presently, no validated clinical index to objectively measure ostomy function is available and few studies have evaluated the impact of a stoma on patient quality of life because of this lack of specific, validated measures.
Only a few studies were published in an attempt to develop a Stoma Quality of Life Scale.6 A study by Marquis et al7 in 2003 proposed the Stoma Care Quality of Life Index. Developed from a quality-of-life index for cancer,8 this instrument was used to measure quality of life in 4,739 patients directly following stoma surgery and at 3, 6, 9, and 12 months later. The study concluded that a stoma patient’s quality of life can be assessed, that it changes over time, and that patient access to specialist ostomy care nurses is particularly important during the first three to six postoperative months. In 2003, Burckhardt and Anderson9 reviewed and summarized the literature regarding the Quality of Life Scale (QOLS) proposed by the psychologist John Flanagan10 in the 1970s, which was adapted for use in groups with chronic illness. They found that the QOLS was low to moderately correlated with physical health status and disease measures. However, the QOLS measures domains that diverse patient groups with chronic illnesses define as quality of life. The authors concluded that the QOLS is a valid instrument for measuring quality of life across patient groups and cultures and is conceptually distinct from health status or other casual indicators of quality of life.
The Fecal Incontinence Quality of Life Scale (FIQOL)11 was designed to determine the quality of life of the patient with fecal incontinence, which is defined as the loss of anal sphincter control or the inability to defer the call to defecate to a socially acceptable time and place, resulting in the release of gas, liquid, or solid stool.12 The psychometric evaluation of the FIQOL scale showed that this fecal incontinence-specific, quality-of-life assessment produces both reliable and valid measurements.11 Many of the issues regarding leakage are inferred in the FIQOL to be pertinent to quality of life with an ostomy. No ostomy function assessment scale has been developed and evaluated.
To assess the validity of the new Cleveland Clinic Florida Ostomy Function Index (CCFOFI) (see Table 1) in patients with a stoma, a cross-sectional survey of patients with ostomies (ileostomy and colostomy) was performed using the FIQOL scale, CCFOFI Index, and the SF-36 quality-of-life index. 
Methods
A cross-sectional postal survey was conducted from July 2000 to September 2001 of patients with an ileostomy or colostomy participating in local United Ostomy Association chapters. Demographic variables included age, gender, and level of education. All patients were asked to complete three questionnaires.
Short Form 36. The validated Short Form 36 general health survey (SF-36)13 has proven reliable in assessing general health in diverse patient populations and healthcare settings.14 It evaluates physical and mental component scales (PCS and MCS) in eight scales: physical function (PF), role-physical (RP), pain index (PI), general health perception (GHP), vitality (VI), social functioning (SF), role-emotional (RE), and mental health index. The SF-36 items and scales are scored so that a higher score indicates a better health status. For example, functioning scales are scored so that a high score indicates freedom from pain. After data entry, items and scores are tallied in three steps: 1) item recoding for the 10 items that require recoding (the process of deriving the item values that will be used to calculate the scale scores; 2) computing new scale scores by summing across items in the same scale (raw scale scores); and 3) transforming raw scale scores to a 0 to 100 scale (transformed scale scores).15
Fecal Incontinence Quality of Life Scale. The FIQOL is composed of 29 items forming four scales: lifestyle (10 items), coping/behavior (nine items), depression/self-perception (seven items), and embarrassment (three items). Patients were asked to complete the questionnaire as it pertained to leakage from the ostomy rather than from fecal incontinence. Scales range from 1 to 5, with 1 indicating a lower functional quality-of-life status. Scale scores are the average responses to all questions in the scale, divided by the number of items in the scale.13 Psychometric evaluation of these scales demonstrates they are both reliable and valid. Each of the scales demonstrates stability over time (test/retest reliability [Cronbach alpha >0.70]).13
Cleveland Clinic Florida Ostomy Function Index. The newly proposed CCFOFI was designed by clinicians and enterostomal therapists primarily to assess function as it pertains to stoma care. The instrument includes variables that measure the frequency of leakage, emptying of the stoma, changes of the appliance, the ease with which appliance changes can be carried out, and the extent to which the stoma affects lifestyle. Skin irritation and breakdown, noise, and odor are not included in the CCFOFI because although these are frequently reported as problems by persons with ostomies,1 significant skin irritation is presumably the result of poor function that affects appliance changes (thus, taken into account) and odor and noise were deemed too subjective for measurement and not truly reflective of stoma function. A high score of 35 indicated poor stoma function; whereas, a (low) score of 7 indicated excellent function. The CCFOFI was developed independently with the enterostomal nurses at the authors’ institution and not based on any previous instrument. This index was pilot-tested for reliability.
Statistical analysis. The mean ages of the two ostomy groups were compared using Statterthwaite t-test. Age and education levels of the two groups were analyzed using a chi-square test. A Spearman coefficient between variables of the SF-36, the CCFOFI, and the FIQOL was determined; results were statistically significant if the probability that a coefficient equal to 0 (no correlation) was less than 5% (P <0.05); confidence interval 95%. Data were entered into a Microsoft Excel (Seattle, Wash) spreadsheet and analyzed using the SPSS (Chicago, Ill) statistical software package.
Results
Of the 99 patients included in the study (average age 72 years), 84 (53%) were male, 55 had a colostomy, and 44 had an ileostomy. The two groups were comparable in age and education (see Table 2). The average
CCFOFI score was 11.97 (range, 7 to 22); no difference in these rates was noted between the two groups (P = 0.78). Differences were noted in the frequency of emptying and changing stoma appliances; patients with ileostomies emptied their appliances more frequently and patients with colostomies changed appliances more frequently (see Table 3). Overall, the CCFOFI correlated with all eight scales of the SF-36 as well as the PCS and MCS, with all variables demonstrating values of P <0.003. The FIQOL data also demonstrated correlation against these parameters (P <0.03 [see Table 4]).
Higher FIQOL scores were noted in the ileostomy patients despite their comparable CCFOFI and SF-36 scores (see Table 5). Subsequent analysis revealed a strong correlation between the SF-36 and the FIQOL in colostomy patients and weaker correlation in the ileostomy group, where only a small number of variables demonstrated correlation strong enough to rule out the null hypothesis (see Table 6 through Table 9).
Undoubtedly, quality of life is significantly affected by the creation of either an ileostomy or colostomy. Patients report effects on physical activities, body image, and lifestyle.1-5 In a questionnaire study of 322 patients, McLeod et al1 demonstrated that only 35% of ileostomy patients believe their stoma function is perfect, suggesting ostomy function varies considerably from patient to patient. Despite this acknowledged variability, to date, it is generally accepted in the medical literature that stoma function is relatively uniform. This study demonstrates that stoma function varies from patient to patient and that this variability correlates with quality of life.
The CCFOFI demonstrated the variability that exists between patients. An average score of 11.97 was observed but scores varied from 7 to 22 (SD 3.68). This variability appears relevant as it correlated significantly with a general quality-of-life score (SF-36) and a quality-of-life score (FIQOL) related to a specific disease. The overall CCFOFI was comparable in ileostomy and colostomy patients. However, subtle differences existed in the frequency of emptying and changing of stoma appliances between the ileostomy and colostomy patients with the former group emptying their stomas more frequently and the latter changing their appliances more frequently. Comparability between the two groups was supported by SF-36 data that similarly showed no difference between the two groups relative to quality of life. Surprisingly, the FIQOL yielded significantly different results between the ileostomy and colostomy patients, despite their comparable CCFOFI. However, these data do not necessarily invalidate the CCFOFI. This hypothesis is supported by the strong correlation between the SF-36 and the CCFOFI in the subgroup analysis between the patients with colostomies and those with ileostomies. Further substantiation is revealed in the weak correlation between the FIQOL and the SF-36 in ileostomies and the strong correlation between the FIQOL and colostomies.
Together, these data suggest that the FIQOL may be a less sensitive instrument for assessing patients with ileostomies. Initially, this conclusion appears counterintuitive because the increased frequency of leakage would be assumed to translate better into the FIQOL whose questions measure the lifestyle, coping/behavior, depression, and embarrassment relative to “fecal leakage.” However, it should be noted that the FIQOL asks the questions relative to when leakage occurs. It appears the nature of this event affects patients with colostomies more than those with ileostomies. The authors hypothesize that the differences in the nature of the effluent produced by these two different types of ostomies likely affects patients differently. Although reason may suggest that a more solid effluent
associated with a colostomy is easier to manage, this hypothesis does not account for odor, which McLeod1 and Nugent2 have demonstrated to be an important issue for persons with ostomies and more commonly observed in colostomy patients.1 This finding would parallel the examination of fecal incontinence performed by Rockwood et al16 which
similarly demonstrated that patients find gas a more important factor than solid stool. These results also opposed the opinion of the surgeons participating in the study, who interpreted stool incontinence as more important than gas. This factor may allow increased sensitivity of the FIQOL instrument in colostomy (as compared to ileostomy) patients. These data demonstrate the need for a stoma-specific, quality-of-life instrument and the potential weakness of using the FIQOL in persons with ostomies, specifically patients with an ileostomy.
Study Strengths and Limitations
The main strength of this study is that the CCFOFI represents a first attempt at developing an objective scoring tool to measure stoma function. To the authors’ knowledge, the FIQOL has never been studied in this patient population. One of the weaknesses associated with this study is that patients all were involved in ostomy support groups, which may have influenced their perception of quality-of-life issues and may not fully represent persons with ostomies in the population uninvolved in the support network. In addition, a relatively small number of patients was involved in the study, due to the low response rate. Further studies to validate the CCFOFI should focus on the general ostomy population and perhaps query persons with ostomies through their care providers. Care regimens can be adapted to reflect patient needs and concerns once the effect of ostomies on quality of life is better established.
Conclusion
Stomas are not uniform in their function and the continued lack of consideration of this variable represents an unaccounted confounder in all stoma literature. However, the CCFOFI is an initial attempt to develop an objective scoring tool to measure stoma function. This will provide caregivers for patients with stomas an objective tool to measure stoma function and quality of life in order to better treat patients and respond to their needs. In addition, a uniform scoring system will allow comparison among data centers.
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