Modified Constipation Assessment Scale is an effective tool to assess bowel function in patients receiving radiotherapy.
Objectives: To determine the reliability and relative construct validity of the Modified Constipation Assessment Scale (MCAS) and use it to assess bowel function in oncology outpatients receiving radiotherapy.
Design: Validation study using data collected as part of a randomised controlled trial. Relative construct validity was investigated by triangulating the MCAS with bowel function assessed by the quality of life questionnaire, QLQ-C30, and professional field notes.
Subjects: Sixty subjects (male:female 51:9; mean age 61.9 [+ or -] 14 years) receiving at least 20 fractions of radiotherapy to the gastrointestinal or head and neck area.
Setting: Australian private radiotherapy centre.
Main outcome measure: Bowel function assessed by the MCAS.
Statistical analyses: Test-retest reliability was assessed by correlation. Mann-Whitney U-scores compared differences between the groups and Fisher's exact tests investigated the proportion of subjects experiencing changes in MCAS scores.
Results: The MCAS proved to be reliable with a mean difference between repeated tests in subjects being less than 1% of the maximum score. For bowel function assessed by the MCAS and the QLQ-C30, 53% of responses were ranked in the same tertile. Of a total of 60 scores, six were misclassified (one false negative by the MCAS, five false negative by the QLQ-C30). The MCAS provided more information than the QLQ-C30 alone for 27 (45%) of the bowel-function scores.
Conclusion: The MCAS has acceptable reliability and relative construct validity and is useful in assessing bowel function in patients receiving radiotherapy. Further work should be conducted on the validity and reliability of the MCAS prior to its use in other populations.
Key words: bowel function, cancer, nutritional status, outcome, quality of life
(Nutr Diet 2005;62:95-101)
The impact of nutrition support in chronic illness often focuses on nutritional status and weight, but may overlook other nutrition-related outcomes such as bowel function. Bowel problems such as constipation are linked to poor health outcomes, decreased quality of life and increased costs due to increased length of stay and medications. (1,2) The first line of treatment for bowel problems often involves dietary modification, exercise and bowel retraining. (3-5) Bowel function should be monitored as part of dietetic practice in patients who are likely to experience bowel problems such as constipation, diarrhoea, flatulence or impaction. The ability to characterise and quantify the severity of disturbances in bowel function could be used to inform dietary management and the need for pharmacological treatment if required. Patients with cancer are at increased risk of disturbances in bowel function, such as constipation or diarrhoea, due to medications, the local effect of the tumour, or as a side effect of the anticancer treatment such as radiotherapy or chemotherapy. (6,7)
While there are several valid and reliable measures of bowel function available, (8-14) they have limitations. These questionnaires only assess constipation and overlook other bowel-function disturbances, or are too detailed to be used as a quick assessment of bowel function in clinical practice. The Modified Constipation Assessment Scale (MCAS), based on a constipation tool previously validated, (15) was developed to be used as a quick and easy measure of bowel function in clinical practice.
Quality of life is becoming a more popular outcome measure in nutrition studies. Dietitians often inquire about patients' bowel function as part of practice. In this study, bowel-function responses were compared with those detected by the European Organisation for Research and Treatment of Cancer quality of life questionnaire QLQ-C30, (16) which included questions on diarrhoea and constipation and professional field notes based on an interview with the dietitian. The aim of this study was to determine the reliability and relative construct validity of the MCAS and its usefulness as a bowel-function measure in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area.
The MCAS was developed and used in a prospective, randomised, controlled trial evaluating the effect of nutrition intervention (NI) in oncology outpatients receiving radio-therapy for tumours in the gastrointestinal or head and neck area. A full description of methods and results of the NI trial are presented elsewhere. (17) Of 78 consecutive patients eligible for inclusion in the study, 60 patients consented to participate. This study was granted ethics approval by The Wesley Hospital Multidisciplinary Ethics Committee (reference number: 98/42) and the Queensland University of Technology University Human Research Ethics Committee (reference number: 2039H).
The MCAS, based on a constipation tool previously validated, (15) included an extra question and was modified to assess any deviations in bowel function away from the norm (Appendix I). The MCAS is a nine-item self-reported questionnaire that takes less than five minutes to complete. If patients rated bowel function as 'no problem', zero point was awarded. One point was awarded if symptoms experienced were reported as 'some problem' and two points were awarded if 'severe problems' were experienced. Symptom scores are summative and could range from 0 (no bowel problems) to 18 (worst possible bowel function). The higher the MCAS score, the greater the bowel-function problems experienced. A higher score may reflect the need for dietary and/or pharmacological interventions.
Quality of life was assessed by the QLQ-C30. (16) This tool consists of 30 questions resulting in five functional scales (physical, role, cognitive, emotional, social), three symptom scales (fatigue, pain, nausea and vomiting), a global health status and quality of life scale and six single items (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea, perceived financial impact of disease and treatment). The validity and the internal and test-retest reliability have been established. (16) For the purpose of this study, the results from the two single items, constipation and diarrhoea, were used.
The MCAS was designed and trialled for reliability and relative construct validity. Test-retest reliability was established by having the first eight patients fill out the MCAS twice with a 1.5-hour delay. During this time subjects completed radiotherapy for the day and finished data collection with the dietitian (40-60 minutes). Subjects completed another questionnaire (quality of life), a nutrition assessment was performed and a standardised dietary history was taken before repeating the MCAS. The 1.5-hour delay allowed a period between surveys in which subjects may have forgotten their previous answers, but would not be so long that subjects' bowel function may have changed in the interim.
Relative construct validity was investigated by triangulating the MCAS responses with bowel function detected by the quality of life questionnaire, QLQ-C30, and professional field notes. Triangulation is the use of multiple methods, usually qualitative and quantitative research, in the study of the same research problem. (18) Bowel-function responses from the MCAS and the QLQ-C30 were divided into tertiles depending on score (a higher score reflects increasing problems). Quasistatistics, a tabulation of the frequency with which certain themes are supported by the data (19) was used to examine the qualitative data.
Qualitative data were obtained from the field notes taken during the structured dietary history interview performed by an experienced dietitian. The same dietitian (EI) conducted all of the interviews. The field notes used a structured template and as well as a section on bowel function, included sections relating to: time spent with the dietitian; weight history; side effects; general diet and influencing factors; medications and/or supplements; counselling recommendations (e.g. goals); information and/or handouts provided; professional opinion (e.g. barriers to goals); and issues to discuss in more detail during the next counselling session. Quantitative and qualitative data discussing patients' bowel function and how this compared to usual function were obtained. Patients were asked whether they were undertaking any dietary or medical treatment to help manage bowel function. Dietary information was collected and other nonbowel function related questionnaires were provided between the bowel function measures so that patients would not be able to immediately replicate the answers from the previous bowel-function enquiry.
During the NI study, subjects were randomised to receive early and intensive NI or the standard practice (SP) of the oncology centre. Bowel function assessed by the MCAS was measured at baseline, four, eight and 12 weeks after commencing radiotherapy.
Statistical analyses were carried out using SPSS Version 10, 2000 (SPSS Inc., Chicago, IL, USA). Correlation analysis using the Pearson's coefficient was used to assess the test-retest reliability of the MCAS. The MCAS responses were ranked in tertiles and descriptive statistics were compared qualitatively with professional field notes. For the NI trial, bowel function was assessed using the MCAS and Mann-Whitney U-scores were used to present the changes in bowel function between the NI and the SP groups at each time point. Fisher's exact tests were used to investigate the proportion of subjects who experienced improvements, maintenance or deterioration in MCAS scores between time points for both groups. Correlation analysis using the Spearman's coefficient was used to assess the association between overall satisfaction with bowel function and the MCAS score.
Reliability and relative construct validity of MCAS
Baseline characteristics of study participants are shown in Table 1. Effective randomisation appeared to have occurred and there were no statistically significant differences in the number of subjects taking opiate medication, for example morphine or codeine at baseline between the NI and the SP groups ([[chi square].sub.(1)] = 1.159; P = 0.282). There were also no significant differences in age, gender, body mass index, nutritional status as assessed by Subjective Global Assessment, (21) median MCAS scores, number of subjects taking opiate medication or fractions of radiotherapy planned for the eight subjects used for the test-retest assessment and the remaining subjects. One of the eight (12.5%) test-retest subjects was receiving radiotherapy to the gastrointestinal area, which is comparable to the 11.7% (7/60) of subjects in the main study who were receiving radiotherapy to the gastrointestinal area (Table 1). The median (range) of MCAS scores for both the test and the retest scores was 1 (0,6). The test-retest MCAS scores were highly correlated (r = 0.98; P < 0.001).
For the MCAS and the QLQ-C30, 53% (n = 32) of responses were ranked in the same tertile (Table 2). Of the 60 scores, there were six misclassifications. Of these, one (2%) was misclassified as a false negative by the MCAS. The remaining five (8%) differences were considered to be misclassified false negatives of the QLQ-C30. This decision was confirmed by professional field notes. For 27 (45% of total (n = 60) scores) of the 28 scores ranked in different tertiles, the scores tested were ranked by the MCAS in a higher tertile than the QLQ-C30, suggesting that the scores from the MCAS provided additional information than that assessed by the QLQ-C30. Professional field notes were later reviewed for evidence of subjective assessment of bowel-function problems. They provided further evidence of relative construct validity. An example of statements relating to bowel function from the field notes are presented in Table 3.
Bowel function as assessed by MCAS as an outcome measure
The median MCAS scores for the four time points are shown in Table 4. Statistically significant differences were obtained at all time points other than baseline for the NI and the SP groups. The NI had a lower median MCAS score at four, eight and 12 weeks, indicating a decreased risk of bowel-function problems.
Fisher's exact tests were used to investigate the proportion of subjects who experienced improvements, maintenance, or deterioration in categorical MCAS scores between measurement time points for both groups. There was a significant difference in the number of subjects who experienced maintenance, improvements or deterioration in MCAS scores at baseline compared with four weeks for those receiving NI compared with SP. There were 21 subjects in the SP group who had deteriorations in MCAS score compared with seven in the NI group (Fisher's exact test[.sub.(2)] = 10.958; P = 0.004). There were no significant differences in MCAS scores between the NI and the SP groups at four compared with eight weeks after commencing radiotherapy treatment (Fisher's exact test[.sub.(2)] = 1.632; P = 0.456).
There was a significant difference in MCAS scores between the NI and the SP groups at eight compared with 12 weeks after commencing radiotherapy treatment, with 16 subjects having NI versus nine subjects having SP maintaining MCAS scores and four in NI versus 11 in SP group having improved MCAS scores (Fisher's exact test[.sub.(2)] = 5.948; P = 0.053).
Overall satisfaction with bowel function was highly correlated with MCAS score at all time points, with a higher satisfaction being associated with a lower MCAS score (baseline: r = -0.695, P < 0.001; week 4: r = -0.799, P < 0.001; week 8: r = -0.765, P < 0.001; week 12: r = -0.731, P < 0.001).
The aim of this study was to determine the reliability and relative construct validity of the MCAS and its usefulness as a bowel-function measure in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area. One of the best ways of assessing bowel function is to measure and assess stool output but this is not possible or practical in many situations and therefore surrogate methods such as recall interviews must be used. (22)
Reliability and relative construct validity of MCAS
In the present study, the data suggest that the MCAS has acceptable reliability and relative constructive validity. The MCAS proved to be reliable with a mean difference between repeated tests in subjects being less than 1% of the maximum score and a highly positive Pearson's correlation coefficient (r = 0.98; P < 0.001). The MCAS appears to assess a broader array of symptoms and is more useful in practice for assessing bowel function than the QLQ-C30, which contains only two items relating to diarrhoea and constipation. The data suggest that the MCAS can differentiate between subjects who perceive themselves as having bowel problems and those who do not, when compared with the bowel-function section of the QLQ-C30 and professional field notes. This ability to differentiate between bowel-function problems provides evidence of the relative construct validity of the MCAS.
The MCAS could detect a greater degree of variation from normal bowel function than the QLQ-C30. In 45% of cases, the MCAS provided more information than the QLQ-C30. These data indicate that while some patients may not be directly experiencing constipation or diarrhoea they may be experiencing other distressing problems, such as bloating, wind or rectal oozing. Comments from the professional field notes confirmed this observation. However, in dietetic practice, practitioners often only enquire about constipation or diarrhoea risk and may not detect other disturbing bowel-function problems. This suggests that the MCAS is suitable as a discriminatory bowel-function tool for use in nutritional assessments as it can identify those issues that patients perceive as problems for them.
Several studies have investigated gastrointestinal symptoms in functional gastrointestinal disorders such as irritable bowel (8-10) and gastroesophageal reflux disease. (12) Talley et al. developed the Bowel Symptom Questionnaire, a valid and reliable measure of gastrointestinal symptoms, which contains over 83 items. (11) The Bowel Symptom Questionnaire provides detailed information and includes questions on general health, laxative use, gender, age, education and marital status. (11) However, it is more suitable for epidemiological studies rather than routine use in clinical practice. No readily available, quick and simple-to-use tools to assess bowel function in oncology patients could be located in the literature.
MCAS as an outcome measure
The data from the randomised, controlled trial (Table 4) suggest that those in the NI group experienced fewer difficulties in bowel function when compared with those in the SP group. At all time points other than baseline, the NI group experienced fewer bowel-function problems as assessed by the MCAS. It is known from the natural history of radiotherapy that side effects are most severe between three to eight weeks after commencing an average course of radiotherapy lasting five weeks. (23) The MCAS scores experienced by those subjects receiving SP confirm these observations. The SP group experienced the highest median MCAS score at week 4, with the median score still greater than the baseline level at week 8. In contrast, the NI group had an improved MCAS score over the first four weeks and this was maintained throughout the radiotherapy treatment and follow up.
Patients receiving radiotherapy to the head and neck area may experience constipation due to the decreased fibre content of the diet as more soft and liquefied meals are consumed to help with any swallowing difficulties that they may be experiencing. Patients receiving radiotherapy to the colon or rectal area may experience diarrhoea. (23)
The results show that there were no statistically significant differences in MCAS scores for the groups at four compared with eight weeks. There was a statistically significant difference between the groups at eight compared with 12 weeks, with more subjects in the SP group experiencing improvements in categorical MCAS score. However, it is important to note that the median MCAS scores for the NI group during this period were 0 so no improvements were possible. By the end of the 12-week study the median MCAS score of the SP group had returned to preradiotherapy treatment levels.
It is difficult to compare these results with other studies as the MCAS is a new tool. The MCAS is based on a constipation assessment scale. (15) However, only reliability and validity studies have been published. No studies using the Constipation Assessment Scale as an outcome measure were identified. We believe that it has a broader use, as in this modified version it can detect a range of symptoms, confirmed by professional field notes.
The median scores observed in this study were lower than anticipated, with the highest individual MCAS score being 8 and the highest median score being 3. The possible range of the MCAS is from 0 to 18. In this study the number of patients receiving radiotherapy to the gastrointestinal area was too small to perform subgroup analyses (Table 1); however, one might anticipate that patients receiving radiotherapy to the gastrointestinal area would have higher MCAS scores. Although a change of 1 on the MCAS score appears clinically significant in the current study population, in other populations, for example inflammatory bowel disease, a larger change in MCAS score may be clinically significant. Professional field notes confirm that those who perceived that they had more problems with their bowels (in terms of number and severity of bowel-function disturbances) had higher MCAS scores.
Patients who scored a higher overall satisfaction with bowel function reported fewer bowel function problems as indicated by the lower MCAS scores. This suggests that the overall satisfaction scale can probably be used as an outcome measure in its own right but the MCAS score provides more information and is more useful in practice and can be used to tailor dietary counselling to address specific problems experienced with bowel function.
No nutrition support studies evaluating bowel function using valid and reliable measures in patients with cancer were detected in the literature. Studies that have investigated bowel problems have generally investigated the impact of pharmacological or dietary interventions on bowel function. Several studies found that increasing fibre intake via dietary modifications was beneficial in reducing constipation symptoms. (24-26) Dietary modifications appear to be more useful in improving bowel function than fibre supplements, which have not resulted in improvements. (21,27) However, there is often poor compliance with consuming the fibre supplements as recommended, which limits the ability to be able to draw conclusions from these studies.
Ross (1) concluded that increasing dietary fibre was not successful in patients with opiate-induced constipation. In the current study the number of subjects taking opiate medication such as codeine or morphine for the relief of pain did not vary between the NI or the SP groups at baseline. It is important to note that even with a significant number of subjects taking medications, improvements in bowel function in the NI group were still observed.
It is well-known that patients with cancer experience problems in bowel function. This may be due to the direct effects of the tumour, as a side effect of treatment such as radiotherapy, or as a side effect of medication. (6,7) Several studies have demonstrated improvements in constipation with dietary modifications. (24-26) It can be suggested that monitoring bowel function as part of dietetic practice would allow for tailoring of nutrition counselling to address disturbances in bowel function and referral for pharmacological treatment when required. The results from the NI trial suggest that the MCAS can be used periodically to monitor patients' bowel function. If the MCAS or other bowel-function tool is not used during practice it is recommended that dietitians routinely ask about more than just constipation or diarrhoea and include questions on gas, bloating and stool frequency. Problems can then be targeted through dietetic counselling and medical management if required.
In the current study the dietitian tailored the nutrition counselling session to address any changes in bowel function. These included gradually increasing fibre and fluid intake if experiencing constipation, and including increased amounts of soluble fibre and limiting gastric stimulants/irritants if experiencing diarrhoea. If severe changes in bowel function were experienced these were discussed with the nurse and/or oncologist for pharmacological management.
While other valid and reliable constipation and gastrointestinal symptom questionnaires are available, the MCAS appears to provide additional useful bowel-function information when compared with constipation risk assessment scales (13) and is quicker than more detailed gastrointestinal symptom questionnaires. (11,14) Further work should be conducted on the validity and reliability of the MCAS prior to its use in other populations.
A limitation of this study was the repeated administration of the MCAS after 1.5 hours. A structured dietary history, nutrition assessment and quality of life assessment tool were undertaken between application of the MCAS so that patients would not be able to immediately replicate the answers from the previous administration. Although a longer time period may have been desirable, it was important that the tool was readministered on the same day so that there were no changes in bowel function. These patients were receiving radiotherapy to the gastrointestinal or head and neck area and it was felt that it was unrealistic to ask them to stay for a longer time period. Future research is required to compare the MCAS with more comprehensive measures of bowel symptoms such as the Bowel Symptom Questionnaire.
The data from the quality of life questionnaire and professional field notes support the use of the MCAS in practice as having acceptable reliability and relative construct validity. The MCAS assesses a broader array of symptoms than other measures traditionally used in dietetic practice and can be used to monitor bowel function during dietary or medical interventions. The MCAS can be used as an outcome measure in NI studies and could be used in conjunction with more traditional outcome tools. The validity and reliability of the MCAS should be confirmed prior to its use in other populations.
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Appendix I. Modified Constipation Assessment Scale (MCAS)
Overall, how would you rate your satisfaction with your bowel function at the moment?
Please circle the number which best applies to you, where one represents extremely dissatisfied and five is very satisfied.
1 2 3 4 5 Extremely dissatisfied Very satisfied Please answer whether you are currently experiencing any of the following by placing a tick ([check]) in the appropriate box. Severe No problem Some problem problem 1) Abdominal distension or bloating 2) Change in the amount of gas passed rectally 3) Less frequent bowel movements 4) More frequent bowel movements 5) Oozing liquid stool 6) Rectal fullness or pressure 7) Small volume of stool 8) Large volume of stool 9) Unable to pass stool
The MCAS is adapted from the Constipation Assessment Scale developed by McMillan and Williams. (15)
The Wesley Research Institute, Brisbane
E. Isenring, PhD, BHS, APD
J. Bauer, PhD, MHSc, GradDipNutrDiet, BSc, APD
School of Public Health, Queensland University of Technology, Brisbane
E. Isenring, PhD, BHS, APD
J. Bauer, PhD, MHSc, GradDipNutrDiet, BSc, APD
School of Health Sciences, University of Newcastle, Newcastle
S. Capra, AM, PhD, MSocSc, BSc, DipNutrDiet, APD
Correspondence: E. Isenring, F1, FMC Flats, Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, SA 5001, Australia.
E. Isenring was the main author of the manuscript, initiated the study, collected data and carried out the statistical analysis and interpretation. J. Bauer initiated the study, assisted in the statistical analysis, interpretation and writing the manuscript. S. Capra initiated the study, supervised the project, assisted in the statistical analysis, interpretation and writing the manuscript.
Table 1. Baseline characteristics for those subjects receiving nutrition intervention and standard practice Nutrition Standard practice Variable (n) intervention (29) (31) Gender (male:female) 24:5 27:4 Head and neck cancer 26 (90) 27 (87) Gastrointestinal cancer 3 (10) 4 (13) Age (years) 60.6 [+ or -] 15.6 63.3 [+ or -] 12.5 Weight (kg) 74.8 [+ or -] 7.8 77.6 [+ or -] 18.2 Height (cm) 174.5 [+ or -] 7.2 171.8 [+ or -] 9.2 BMI (kg/[m.sup.2]) 25.2 [+ or -] 4.4 26.4 [+ or -] 4.5 SGA A (well nourished) 17 (59) 22 (71) B (suspected or moderately 9 (31) 8 (26) malnourished) C (severely malnourished) 3 (10) 1 (3) Global QoL (QLQ-C30) 67.7 [+ or -] 18.8 75.3 [+ or -] 19.2 Continuous variables presented as mean [+ or -] SD for normally distributed variables or median (range) for data that are not normally distributed. Categorical variables are presented as counts (%). BMI = body mass index (weight/height[.sup.2]). SGA = Subjective Global Assessment, a nutritional status assessment measure. (20) Global QoL = global quality of life assessed by the European Organisation for Research and Treatment of Cancer QLQ-C30. (16) Table 2. Comparison of bowel-function scores ranked by the Modified Constipation Assessment Scale (MCAS) (a) and by the quality of life tool (QLQ-C30) (b) for 60 outpatients receiving radiotherapy to the gastrointestinal or head and neck area No. (%) (c) Bowel-function ranking (n = 60) MCAS (a) and QLQ-C30 (b) ranked in the same tertile 32 (53) MCAS and QLQ-C30 ranked in different tertiles 28 (47) MCAS ranked in 3rd and QLQ-C30 in 2nd tertile 15 (25) MCAS ranked in 2nd and QLQ-C30 in 1st tertile 7 (12) Misclassification MCAS ranked in 3rd and QLQ-C30 in 1st tertile 5 (8) (false negative) MCAS ranked in 1st and QLQ-C30 in 2nd tertile 1 (2) (false negative) (a) MCAS scores range from 0 to 18. (b) European Organisation for Research and Treatment of Cancer QLQ-C30 scores range from 2 to 8. (16) (c) % refers to proportion of total (n = 60) scores. Table 3. Examples of bowel-function comments recorded in the professional field notes for oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area Examples of comments Patient study no. Generally the bowels are OK but they do become 01 sluggish with codeine-containing painkillers I tried some nutrition supplement but they gave me 06 gas and some diarrhoea I was clogged up, but wasn't worried as I knew I 34 wasn't eating much. Less in, less out ... The bowels aren't opening as often and when I do go 36 they are smaller and harder than normal. I think it's because I'm not as active and eating more sloppy foods I definitely get clogged up with a liquid diet. I 45 seem to go from one extreme to another and end up with diarrhoea if I take too much laxative I'm still regular as clockwork--7.30 a.m. every 46 morning--you could set your clock by it The bowels are excellent. I've had no problems at 50 all in that department since starting radiotherapy Table 4. MCAS (a) scores in 60 ambulatory radiation-oncology patients receiving either nutrition intervention or standard practice Nutrition intervention Standard practice Factors n Median (min, max) Median (min, max) P-value (b) MCAS score Week 0 60 1.0 (0, 4) 1.0 (0, 4) 0.136 Week 4 57 0.0 (0, 5) 3.0 (0, 8) 0.012 Week 8 55 0.0 (0, 5) 2.0 (0, 7) 0.012 Week 12 54 0.0 (0, 6) 1.0 (0, 6) 0.030 (a) MCAS scores range from 0 to 18. Higher MCAS score indicates higher risk of bowel-function problems. (b) Based on Mann-Whitney U-scores.
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|Title Annotation:||Original research|
|Publication:||Nutrition & Dietetics: The Journal of the Dietitians Association of Australia|
|Date:||Jun 1, 2005|
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