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The impact of functional gastrointestinal disorders on quality of life
THE AMERICAN JOURNAL OF GASTROENTEROLOGY © 2000 by Am. Coll. of Gastroenterology Published by Elsevier Science Inc.
Vol. 95, No. 1, 2000 ISSN 0002-9270/00/$20.00 PII S0002-9270(99)00794-7
The Impact of Functional Gastrointestinal Disorders on Quality of Life Natasha A. Koloski, B.A. (Hons), Nicholas J. Talley, M.D., Ph.D., F.A.C.G., and Philip M. Boyce, M.D. Departments of Medicine, and Department of Psychological Medicine, University of Sydney at Nepean Hospital, Penrith, New South Wales, Australia
OBJECTIVE: The impact of functional gastrointestinal disorders (FGIDs) on quality of life is unknown. We aimed to evaluate whether FGIDs impair quality of life in terms of mental and physical functioning in patients and nonpatients. METHODS: A random sample of 4500 subjects, representative of the Australian population, were mailed a questionnaire on gastrointestinal symptoms in the past 12 months. Quality of life was assessed using the valid SF-12, in which the lower the scores, the greater the impairment of quality of life. The response rate was 72%. RESULTS: Among those fulfilling Rome I criteria for a diagnosis of a FGID (n ⫽ 1006) versus those not having a FGID (n ⫽ 1904) (healthy controls), there was a significant association with impaired mental (43.9 vs 48.1) and physical (47.7 vs 51.6) functioning. Mental functioning (43.3 vs 44.9) and physical functioning (46.0 vs 50.5) was significantly more impaired in patients versus nonpatients with a FGID. Furthermore, nonpatients with a FGID had more impaired mental and physical functioning than healthy controls. CONCLUSION: FGIDs impair quality of life, particularly in those that consult for health care. (Am J Gastroenterol 2000; 95:67–71. © 2000 by Am. Coll. of Gastroenterology)
of life as manifested by poorer sleep, and problems with employment, relationships, sexual functioning, leisure, travel and diet (6 – 8). Those patients with IBS who rate their symptoms as very severe have been reported to have the poorest productivity and functioning across a variety of domains (9). Other studies have found that FGIDs such as functional dyspepsia and functional constipation impact negatively on quality of life (10, 11). These studies have not been population-based and have often lacked adequate control groups. No community studies have determined whether the impact of FGIDs on quality of life is more impaired in patients versus nonpatients in the general population. We aimed, in a population-based study, 1) to determine the impact of FGIDs on quality of life using a well validated quality of life measure (SF-12), and 2) to ascertain whether there is a relationship between quality of life and health care seeking for FGIDs. We hypothesized that persons with an FGID will have a reduced quality of life in terms of mental and physical functioning compared with those without a FGID, and that patients with a FGID will exhibit greater impairment of quality of life than those with symptoms who have not sought health care.
MATERIALS AND METHODS INTRODUCTION Health-related quality of life broadly describes the mental and physical functioning and the subjective experience of a person in relation to their health (1, 2). The importance of measuring quality of life is becoming widely recognized, because it can enhance the physician’s assessment of health status and is useful in the appraisal of therapeutic interventions (3). This is an area of research, however, that has received very little attention in relation to the functional gastrointestinal disorders (FGIDs). These disorders, characterized by chronic or recurrent symptoms attributed to the gastrointestinal tract that are not explained by a structural cause, are common in the community (4, 5). However, no comprehensive studies have examined the impact of these disorders on quality of life. Of all the FGIDs, the impact of irritable bowel syndrome (IBS) on quality of life has received the most attention. Patients with IBS have been found to have a reduced quality
Subjects A random sample of 4,500 persons aged ⱖ18 yr, with an equal number of men and women, were enrolled in the study. The sampling frame consisted of the 1996 Electoral Role for the local Government Area of Penrith, which represents 3.6% of the Sydney population. Based on 1991 census data (12), Penrith is homogeneous in terms of its sociodemographics and ethnic composition with the Australian population, except that its inhabitants are slightly younger and it has a slightly higher socioeconomic status. Procedure The mailing of this questionnaire to subjects was carried out in three batches of 500, 2000, and 2000. Subjects in the first batch were randomly divided into four experimental groups in an effort to test the effectiveness of a short versus long version of the questionnaire, and a lottery ticket versus no lottery ticket, on response rates before proceeding with the bulk of the mailing. The results indicated that questionnaire
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length was not linked with response rates for this sample. Thus, the rest of the subjects received a long version of the questionnaire, which was identical to the short version except that additional psychological measures were incorporated toward the end of the questionnaire. A lottery incentive was sent to the majority of subjects as an appreciative gesture along with a stamped self-addressed envelope, pencil, and personalized cover letter. A translation sheet specifying alternative instructions was provided to all subjects to ensure that the study was not biased with respect to non– English-speaking persons. Nonrespondents were extensively followed-up over a period of 10 wk, with a replacement survey sent out at wk 4 and reminder letters sent out in wk 2, 5, 7, and 10. A telephone call was also made to subjects in wk 9. Those subjects in batch 1 received an additional replacement survey at wk 8, and a telephone call instead of a reminder letter was undertaken in wk 7. Questionnaire The complete version of the 32-page questionnaire contained 216 items. The first sections of the questionnaire incorporated a full spectrum of questions used to diagnose the FGIDs applying the symptom-based Rome criteria (4). The Rome criteria represents the culmination of work from several international working teams, and diagnostic items for 25 FGIDs are available (4). These disorders are divided according to specific anatomic regions: esophagus, gastroduodenum, bowel, abdomen, biliary, and anorectum. For the purposes of this study, our questionnaire assessed 19 FGIDs, excluding FGIDs that were unspecified and those FGIDs that we could not identify appropriately with a survey, as specific clinical tests were necessary for a diagnosis. The categories were not mutually exclusive. The prevalence of FGIDs and details of health care seeking in this population are reported elsewhere (13–15). The Rome criteria specifies that symptoms must be present for ⱖ3 months and there must be no evidence of structural disease that would explain the symptoms. For example, to assess whether a person fulfilled the criteria for functional chest pain, we asked, “In the past 12 months, have you ever had pain in the center of your chest that was not heartburn?”. If the subject answered yes, we then asked, “Did this pain keep happening over a period of 3 months or more?”. Also in these early sections of the questionnaire, we asked about the number of times health care was sought over the past 12 months for symptoms corresponding to FGIDs. The latter sections of the questionnaire consisted of previously validated psychological questionnaires. The Eysenck Personality Questionnaire (EPQ) (16) contains 24 items that assess neuroticism and extroversion. The 14-item Delusions-Symptoms-States Inventory (DSSI) (17) measures anxiety and depression, and the Sphere (18) provides a score for somatic distress. Also included were questions relating to age, sex, educational level, and country of birth. Quality of life was assessed using the valid SF-12 (19, 20). This is a 12-item generic quality of life measure that
AJG – Vol. 95, No. 1, 2000
assesses mental and physical functioning over the past 4 wk. Examples of questions assessing mental functioning included “Have you felt calm and peaceful?” and “Have you felt down hearted and blue?”. Physical functioning was addressed with questions such as “During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?” Statistical Analyses Univariate analyses were performed on the data to assess the relationship between having a FGID diagnosis and quality of life as well as health care seeking for FGIDs and quality of life. The indices for quality of life and for mental and physical functioning were analyzed for associations with having a FGID versus not having one, and for consulters versus nonconsulters, using t tests. Stepwise logistic regression analysis was used to assess whether impaired mental and physical functioning was associated with the probability of having a FGID and seeking health care for a FGID. All p values calculated were two tailed; the ␣ level of significance was set at 0.05.
RESULTS Sample Characteristics Of the original 4500 subjects mailed the questionnaire, 398 subjects had moved or were overseas, 11 subjects had died, 24 subjects were seriously ill, 75 subjects explicitly refused to participate, and 1082 subjects failed to respond. A completed questionnaire was returned by 2910 subjects, giving an overall response rate of 72%. This sample was generally similar with respect to the distribution of men (48.7%) and women (51.3%), and the mean age was 43.8 yr. The majority of people were born in Australia (72%), and slightly more than half (55.6%) had completed high school or above. There were slightly more female responders (51.9%) than nonresponders (47.0%) to the questionnaire. Impact of FGIDs on Quality of Life We compared subjects who met criteria for any FGID (n ⫽ 1006) with those who did not meet criteria for any FGID (n ⫽ 1904) on the mental and physical subscales derived from the SF-12. The mean scores for mental and physical components on the SF-12 for our control group (i.e., those who did not meet criteria for any FGID), were 48.1 and 51.6, respectively. The means scores are shown in Table 1, where the lower the score is indicative of more impairment in quality of life. Having an FGID was significantly associated with impaired mental and physical functioning, except for mental functioning in those persons with rumination syndrome and aerophagia, and physical functioning for persons reporting dyschezia. All disorders grouped with respect to anatomic region were significantly associated with reduced mental and physical functioning when compared with controls (Table 2). By stepwise logistic regression, impaired mental func-
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GI Disorders and Quality of Life
Table 1. Mean Scores on Mental and Physical Functioning From the SF-12 for Functional Gastrointestinal Disorders Diagnosis Present FGID
Mental
Physical
Globus (n ⫽ 107) Rumination Syndrome (n ⫽ 25) Functional chest pain (n ⫽ 146) Functional heartburn (n ⫽ 403) Functional dysphagia (n ⫽ 81) Functional dyspepsia (n ⫽ 246) Aerophagia (n ⫽ 60) Irritable bowel syndrome (n ⫽ 127) Functional abdominal bloating (n ⫽ 325) Functional constipation (n ⫽ 227) Functional diarrhea (n ⫽ 237) Functional abdominal pain syndrome (n ⫽ 299) Gallbladder dysfunction (n ⫽ 136) Functional incontinence (n ⫽ 57) Proctalgia fugax (n ⫽ 57) Dyschezia (n ⫽ 40)
41.61* 43.92 41.69* 41.69* 42.61* 43.06* 44.06 41.54* 42.63* 40.98* 43.05* 43.29*
46.93* 43.88* 47.10* 47.10* 44.24* 45.18* 46.61* 44.76* 46.04* 47.37* 47.15* 44.95*
43.39* 43.23 40.57* 40.39*
45.62* 44.36* 46.11* 47.67
* p ⬍ 0.05 for having FGID diagnosis versus no FGID diagnosis (univariate analyses).
tioning (odds ratio [OR] ⫽ 0.95, 95% confidence intervals [CI] ⫽ 0.94, 0.96) and physical functioning (OR ⫽ 0.95, 95% CI 0.94, 0.96) were significantly associated with the probability of having any FGID. However, impairment in mental and physical functioning only explained 3.5% and 3.2% of the deviance, respectively. The association of impaired quality of life with a diagnosis of FGID remained significant after controlling for the effects of neuroticism and symptom severity (abdominal pain and bowel dysfunction) in our final model (mental functioning OR ⫽ 0.98, 95% CI 0.96, 0.99 and physical functioning OR ⫽ 0.96, 95% CI 0.95, 0.98). Health Care Seeking for FGIDs and Quality of Life The majority of persons with a FGID had consulted a physician for symptoms over the past 12 months. Quality of life as assessed by both mental and physical functioning from the SF-12 was significantly impaired in persons consulting for any FGID and for anorectal disorders (Table 3) compared with nonpatients. When grouped according to Table 2. Mean Scores for Mental and Physical Functioning on the SF-12 for Functional Gastrointestinal Disorders According to Anatomic Region Diagnosis Present FGID
Mental
Physical
Esophageal disorders (n ⫽ 573) Gastroduodenal disorders (n ⫽ 274) Bowel disorders (n ⫽ 585) Biliary disorders (n ⫽ 136) Anorectal disorders (n ⫽ 164) Any FGID (n ⫽ 1006)†
43.91* 42.81* 42.73* 43.29* 41.90* 43.9*
47.13* 45.67* 51.03* 44.95* 46.15* 47.7*
* p ⬍ 0.05 for having a FGID diagnosis versus no FGID diagnosis. † Note that numbers in total do not equal numbers in individual diagnostic categories because of overlap.
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anatomic region, physical functioning was significantly impaired in patients versus nonpatients except for those with biliary disorders. For specific FGIDs, mental functioning was significantly reduced in patients with functional incontinence, functional chest pain, and functional dysphagia (Table 4). Physical functioning was poorer in patients for the following FGIDs: functional heartburn, functional dyspepsia, irritable bowel syndrome, functional abdominal bloating, functional diarrhea, and functional abdominal pain syndrome. By stepwise logistic regression, impaired mental functioning (odds ratio [OR] ⫽ 0.96, 95% CI ⫽ 0.95, 0.97) and physical functioning (OR ⫽ 0.95, 95% CI 0.94, 0.96) were significantly associated with the probability of seeking health care for any FGID. However, impairment in mental and physical functioning only explained 2.7% and 3.9% of the deviance, respectively. The effect of quality of life on seeking health care for a FGID remained significant after controlling for the effects of neuroticism and symptom severity in our final model (mental functioning OR ⫽ 0.98, 95% CI 0.96, 0.99 and physical functioning OR ⫽ 0.96, 95% CI 0.94, 0.97). Controls Versus Nonconsulters With a FGID Univariate analyses showed that nonpatients with a FGID versus controls were significantly more impaired in terms of both mental functioning (mean scores 44.9 and 48.1, respectively) and physical functioning (mean scores 50.5 and 51.6, respectively).
DISCUSSION We examined for the first time the impact of all the FGIDs on quality of life. The prevalence of the FGIDs in this study (34.6%) was substantially lower than that reported in the US householder survey (70.1%). This may be due to our strict application of the 3-month requirement for symptom duration as specified in the Rome I criteria. We found that quality of life in terms of mental or physical functioning as measured by the SF-12 was significantly impaired in the majority of the FGIDs. Patients with a FGID had significant impairment in both mental and physical functioning compared with nonpatients, although the latter were more impaired than healthy controls. For the individual disorders, physical rather than mental functioning tended to be significantly more impaired in patients than nonpatients. Our results confirm previous findings that patients with specific FGIDs such as IBS, functional dyspepsia and functional constipation have a reduced quality of life (6 –11). Talley et al. using the SF-36 found patients with functional dyspepsia to have poorer mental health, social functioning, and health perception compared with healthy controls and patients with other disease (10). Similarly, Whitehead et al. using the SF-36 found that patients with IBS had a greater impairment in functioning than nonpatients, who, in turn, were more impaired than controls (6). This association re-
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Table 3. Mean Scores on Mental and Physical Functioning From the SF-12 for Patients Versus Nonpatients According to Anatomic Region FGID (n) Esophageal disorders (573) Gastroduodenal disorders (274) Bowel disorders (585) Biliary disorder (136) Anorectal disorders (164) Any FGID (1006)
Patients
Nonpatients
Patients (n)
Mental
Physical
Mental
Physical
311 201 340 106 82 625
44.12 43.03 42.39 43.88 40.24 43.29
45.04 44.42 45.23 44.92 43.90 46.0
43.65 42.22 43.20 43.40 43.56* 44.9*
49.64* 49.07* 49.87* 48.04 48.39* 50.5*
* p ⬍ 0.05 for patients versus nonpatients.
mained significant when the confounding effects of neuroticism and psychological distress were controlled for in the analyses (6). Impairment in quality of life as a predictor of health care seeking for any FGID also remained significant in our study after the effects of neuroticism were taken into account. Controlling for symptom severity in the present study did not alter the impact of mental and physical functioning in those persons who had a FGID diagnosis. Thus, we conclude that impairment in quality of life appears to drive health care seeking behavior for FGIDs in general, although this explains only a very small amount of health care seeking behavior. The strengths of our study included the use of a random population sample, examination of quality of life for all the FGIDs, and the use of a valid quality of life measure, the SF-12 (20). Limitations with previous studies and ours, however, include the use of a general rather than a diseasespecific measure of quality of life that may not sensitively measure the impact of all the functional disorders of the gastrointestinal tract. For example, IBS have been found to negatively affect psychological well-being (21–23): for example, the fear of not being able to have a bowel movement (24). However, specific measures of quality of life for all the FGIDs are currently unavailable and a generic measure
allows the impact of all the disorders to be directly compared. The development of the IBSQOL, a measure to assess quality of life in persons with IBS, represents one attempt to overcome the limitations of using generic measures (24). Hahn et al. (9), using this measure, found that IBS patients who perceived their symptoms to be very severe had reduced scores on quality of life indices including physical and emotional role, vitality, sexual relations, sleep, social functioning, mental health, and diet (9). Similarly, Patrick et al. identified lower scores on the IBSQOL subscales of interference with activity, food avoidance, and health worry in a sample of IBS patients (24). The recent development of the functional digestive disorders quality of life questionnaire is proving to be a valuable tool for measuring the physical, psychological, and perceptual ramifications of both IBS and functional dyspepsia (25). This study has provided important new information on the impact of all the FGIDs on quality of life. Further understanding of the impact of these disorders on quality of life should help with the planning of appropriate interventions for this condition. Because these disorders are not typically associated with significant mortality and morbidity, measuring quality of life may provide a more suitable
Table 4. Mean Scores on Mental and Physical Functioning From the SF-12 for Patients Versus Nonpatients FGID (n) Globus (107) Rumination Syndrome (25) Functional chest pain (146) Functional heartburn (403) Functional dysphagia (81) Functional dyspepsia (246) Aerophagia (60) Irritable bowel syndrome (127) Functional abdominal bloating (325) Functional constipation (227) Functional diarrhea (237) Functional abdominal pain syndrome (299) Gallbladder dysfunction (136) Functional incontinence (57) Proctalgia fugax (57) Dyschezia (40) * p ⬍ 0.05 for patients versus nonpatients.
Patients
Nonpatients
Patients (n)
Mental
Physical
Mental
Physical
47 6 92 197 35 186 25 103 159 98 109 227 100 30 18 20
41.65 41.31 43.36 44.91 42.61 43.56 44.48 41.50 43.09 40.28 42.05 43.35 43.38 40.68 38.88 40.05
46.23 42.87 45.67 43.90 44.24 44.10 43.77 43.59 43.62 45.99 44.71 43.77 44.92 43.13 43.35 45.69
41.57 44.74 38.77* 43.57 46.77* 41.54 43.77 41.72 42.19 41.49 43.88 43.10 43.40 45.67* 41.35 40.73
47.48 44.20 49.57* 50.21* 50.71* 48.49* 48.67 49.78* 48.36* 48.39 49.21* 48.66* 48.04 47.11 47.38 49.65
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way of judging the efficacy of current treatments. Future research in this area may benefit from the development of a general functional GI disorder quality of life instrument that incorporates the full spectrum of activities and areas in life that are likely to be affected by all of these disorders.
ACKNOWLEDGMENT Supported by a research grant from the National Health and Medical Research Council of Australia. Reprint requests and correspondence: Nicholas J. Talley, M.D., Department of Medicine, Clinical Sciences Building, Nepean Hospital, P.O. Box 63, Penrith NSW 2751, Australia. Received May 17, 1999; accepted Sep. 7, 1999.
GI Disorders and Quality of Life
10. 11. 12. 13.
14. 15.
REFERENCES 1. Guyatt GH, Veldhuyzen Van Zanten SJO, Feeny DH, et al. Measuring quality of life in clinical trials: a taxonomy and review. Can Med Assoc J 1989;140:1441– 8. 2. Guyatt GH. Measuring quality of life: A review of means of measurement in clinical trials of new medicines, Pharmaceut Med 1987;2:49 – 60. 3. Dimenas E, Glise H, Hallerback B, et al. Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens? Scand J Gastroenterol 1993; 28:681–7. 4. Drossman DA, Richter JE, Talley NJ, et al., eds. The functional gastrointestinal disorders. Diagnosis, pathophysiology and treatment—A multinational consensus. Boston: Little, Brown, 1994. 5. Drossman DA, Li Z, Andruzzi E, et al. U.S. householder survey of functional gastrointestinal disorders: Prevalence, sociodemography and health impact. Dig Dis Sci 1993;38: 1569 – 80. 6. Whitehead WE, Burnett CK, Cook III EW, et al. Impact of irritable bowel syndrome on quality of life. Dig Dis Sci 1996; 41:2248 –53. 7. O’Keefe EA, Talley NJ, Zinsmeister AR, et al. Bowel disorders impair functional status and quality of life in the elderly: A population-based study. J Gerontol Med Sci 1995;50A: M184 –9. 8. McGee HM, O’Boyle CA, Hickey A, et al. SEIQoL with a healthy and a gastroenterology population. Psychol Med 1991; 21:749 –59. 9. Hahn BA, Kirchdoerfer LJ, Fullerton S, et al. Patient perceived severity of irritable bowel syndrome in relation to
16. 17. 18.
19. 20. 21. 22. 23.
24. 25.
71
symptoms, health resource utilization and quality of life. Aliment Pharmacol Ther 1997;11:553–9. Talley NJ, Weaver AL, Zinsmeister AR. Impact of functional dyspepsia on quality of life. Dig Dis Sci 1995;40:584 –9. Glia A, Lindberg G. Quality of life in patients with different types of functional constipation. Scand J Gastroenterol 1997; 32:1083–9. Australian Bureau of Statistics: 1991 Census of population and housing, basic community profile: Area 6350 Penrith, ABS catalogue No. 2722.1. Koloski NA, Talley NJ, Boyce PM. High prevalence and striking overlap of the functional gastrointestinal disorders (FGIDs): Is the current Rome classification worthwhile? Gastroenterology 1999;116:A305. Koloski NA, Talley NJ, Boyce PM. High levels of health care utilization for functional gastrointestinal disorders (FGIDs) in a community. Gastroenterology 1999;116:A4427. Koloski NA, Talley NJ, Boyce PM. Psychological mechanisms are linked to the pathophysiology of the functional gastrointestinal disorders and not just health care seeking. Gastroenterology 1999;116:A4428. Grayson DA. Latent trait analysis of the Eysenck Personality Questionnaire. J Psychiatry Res 1986;20:217–35. Bedford A, Foulds GA. Validation of the Delusions-Symptoms-States Inventory. Br J Med Psychol 1977;50:163–71. Hadzi-Pavlovic D, Hickie I, Ricci C. The Sphere. Somatic and psychological health report. Development and Initial Evaluation. Technical Report TR-97-002, School of Psychiatry, University of NSW and Academic Department of Psychiatry at St George Hospital, 1997. Ware JE, Kosinski M, Keller SD. SF-12: How to score the SF-12 physical and health summary scales. The Health Institute, New England Medical Center, Boston, MA, 1993. Ware JE, Kosinski M, Keller SD. A 12-item short-form health survey. Construction of scales and preliminary tests of reliability and validity. Med Care 1995;34:220 –3. Talley NJ, Phillips SF, Bruce B, et al. Multisystem complaints in patients with the irritable bowel syndrome and functional dyspepsia. Eur J Gastroenterol Hepatol 1991;3:71–7. Zighelboim J, Talley NJ. What are functional bowel disorders? Gastroenterology 1993;104:1196 –1201. Drossman DA, M Kee DC, Sandler RS, et al. Psychosocial factors in the irritable bowel syndrome. A multivariate study of patients and non-patients with irritable bowel syndrome. Gastroenterology 1988;95:701– 8. Patrick DL, Drossman DA, Frederick IO, et al. Quality of life in persons with irritable bowel syndrome. Development and validation of a new measure. Dig Dis and Sci 1998;43:400 –11. Chassany O, Marquis P, Scherrer B. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut 1999;44:527–33.
Vol. 95, No. 1, 2000 ISSN 0002-9270/00/$20.00 PII S0002-9270(99)00794-7
The Impact of Functional Gastrointestinal Disorders on Quality of Life Natasha A. Koloski, B.A. (Hons), Nicholas J. Talley, M.D., Ph.D., F.A.C.G., and Philip M. Boyce, M.D. Departments of Medicine, and Department of Psychological Medicine, University of Sydney at Nepean Hospital, Penrith, New South Wales, Australia
OBJECTIVE: The impact of functional gastrointestinal disorders (FGIDs) on quality of life is unknown. We aimed to evaluate whether FGIDs impair quality of life in terms of mental and physical functioning in patients and nonpatients. METHODS: A random sample of 4500 subjects, representative of the Australian population, were mailed a questionnaire on gastrointestinal symptoms in the past 12 months. Quality of life was assessed using the valid SF-12, in which the lower the scores, the greater the impairment of quality of life. The response rate was 72%. RESULTS: Among those fulfilling Rome I criteria for a diagnosis of a FGID (n ⫽ 1006) versus those not having a FGID (n ⫽ 1904) (healthy controls), there was a significant association with impaired mental (43.9 vs 48.1) and physical (47.7 vs 51.6) functioning. Mental functioning (43.3 vs 44.9) and physical functioning (46.0 vs 50.5) was significantly more impaired in patients versus nonpatients with a FGID. Furthermore, nonpatients with a FGID had more impaired mental and physical functioning than healthy controls. CONCLUSION: FGIDs impair quality of life, particularly in those that consult for health care. (Am J Gastroenterol 2000; 95:67–71. © 2000 by Am. Coll. of Gastroenterology)
of life as manifested by poorer sleep, and problems with employment, relationships, sexual functioning, leisure, travel and diet (6 – 8). Those patients with IBS who rate their symptoms as very severe have been reported to have the poorest productivity and functioning across a variety of domains (9). Other studies have found that FGIDs such as functional dyspepsia and functional constipation impact negatively on quality of life (10, 11). These studies have not been population-based and have often lacked adequate control groups. No community studies have determined whether the impact of FGIDs on quality of life is more impaired in patients versus nonpatients in the general population. We aimed, in a population-based study, 1) to determine the impact of FGIDs on quality of life using a well validated quality of life measure (SF-12), and 2) to ascertain whether there is a relationship between quality of life and health care seeking for FGIDs. We hypothesized that persons with an FGID will have a reduced quality of life in terms of mental and physical functioning compared with those without a FGID, and that patients with a FGID will exhibit greater impairment of quality of life than those with symptoms who have not sought health care.
MATERIALS AND METHODS INTRODUCTION Health-related quality of life broadly describes the mental and physical functioning and the subjective experience of a person in relation to their health (1, 2). The importance of measuring quality of life is becoming widely recognized, because it can enhance the physician’s assessment of health status and is useful in the appraisal of therapeutic interventions (3). This is an area of research, however, that has received very little attention in relation to the functional gastrointestinal disorders (FGIDs). These disorders, characterized by chronic or recurrent symptoms attributed to the gastrointestinal tract that are not explained by a structural cause, are common in the community (4, 5). However, no comprehensive studies have examined the impact of these disorders on quality of life. Of all the FGIDs, the impact of irritable bowel syndrome (IBS) on quality of life has received the most attention. Patients with IBS have been found to have a reduced quality
Subjects A random sample of 4,500 persons aged ⱖ18 yr, with an equal number of men and women, were enrolled in the study. The sampling frame consisted of the 1996 Electoral Role for the local Government Area of Penrith, which represents 3.6% of the Sydney population. Based on 1991 census data (12), Penrith is homogeneous in terms of its sociodemographics and ethnic composition with the Australian population, except that its inhabitants are slightly younger and it has a slightly higher socioeconomic status. Procedure The mailing of this questionnaire to subjects was carried out in three batches of 500, 2000, and 2000. Subjects in the first batch were randomly divided into four experimental groups in an effort to test the effectiveness of a short versus long version of the questionnaire, and a lottery ticket versus no lottery ticket, on response rates before proceeding with the bulk of the mailing. The results indicated that questionnaire
68
Koloski et al.
length was not linked with response rates for this sample. Thus, the rest of the subjects received a long version of the questionnaire, which was identical to the short version except that additional psychological measures were incorporated toward the end of the questionnaire. A lottery incentive was sent to the majority of subjects as an appreciative gesture along with a stamped self-addressed envelope, pencil, and personalized cover letter. A translation sheet specifying alternative instructions was provided to all subjects to ensure that the study was not biased with respect to non– English-speaking persons. Nonrespondents were extensively followed-up over a period of 10 wk, with a replacement survey sent out at wk 4 and reminder letters sent out in wk 2, 5, 7, and 10. A telephone call was also made to subjects in wk 9. Those subjects in batch 1 received an additional replacement survey at wk 8, and a telephone call instead of a reminder letter was undertaken in wk 7. Questionnaire The complete version of the 32-page questionnaire contained 216 items. The first sections of the questionnaire incorporated a full spectrum of questions used to diagnose the FGIDs applying the symptom-based Rome criteria (4). The Rome criteria represents the culmination of work from several international working teams, and diagnostic items for 25 FGIDs are available (4). These disorders are divided according to specific anatomic regions: esophagus, gastroduodenum, bowel, abdomen, biliary, and anorectum. For the purposes of this study, our questionnaire assessed 19 FGIDs, excluding FGIDs that were unspecified and those FGIDs that we could not identify appropriately with a survey, as specific clinical tests were necessary for a diagnosis. The categories were not mutually exclusive. The prevalence of FGIDs and details of health care seeking in this population are reported elsewhere (13–15). The Rome criteria specifies that symptoms must be present for ⱖ3 months and there must be no evidence of structural disease that would explain the symptoms. For example, to assess whether a person fulfilled the criteria for functional chest pain, we asked, “In the past 12 months, have you ever had pain in the center of your chest that was not heartburn?”. If the subject answered yes, we then asked, “Did this pain keep happening over a period of 3 months or more?”. Also in these early sections of the questionnaire, we asked about the number of times health care was sought over the past 12 months for symptoms corresponding to FGIDs. The latter sections of the questionnaire consisted of previously validated psychological questionnaires. The Eysenck Personality Questionnaire (EPQ) (16) contains 24 items that assess neuroticism and extroversion. The 14-item Delusions-Symptoms-States Inventory (DSSI) (17) measures anxiety and depression, and the Sphere (18) provides a score for somatic distress. Also included were questions relating to age, sex, educational level, and country of birth. Quality of life was assessed using the valid SF-12 (19, 20). This is a 12-item generic quality of life measure that
AJG – Vol. 95, No. 1, 2000
assesses mental and physical functioning over the past 4 wk. Examples of questions assessing mental functioning included “Have you felt calm and peaceful?” and “Have you felt down hearted and blue?”. Physical functioning was addressed with questions such as “During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?” Statistical Analyses Univariate analyses were performed on the data to assess the relationship between having a FGID diagnosis and quality of life as well as health care seeking for FGIDs and quality of life. The indices for quality of life and for mental and physical functioning were analyzed for associations with having a FGID versus not having one, and for consulters versus nonconsulters, using t tests. Stepwise logistic regression analysis was used to assess whether impaired mental and physical functioning was associated with the probability of having a FGID and seeking health care for a FGID. All p values calculated were two tailed; the ␣ level of significance was set at 0.05.
RESULTS Sample Characteristics Of the original 4500 subjects mailed the questionnaire, 398 subjects had moved or were overseas, 11 subjects had died, 24 subjects were seriously ill, 75 subjects explicitly refused to participate, and 1082 subjects failed to respond. A completed questionnaire was returned by 2910 subjects, giving an overall response rate of 72%. This sample was generally similar with respect to the distribution of men (48.7%) and women (51.3%), and the mean age was 43.8 yr. The majority of people were born in Australia (72%), and slightly more than half (55.6%) had completed high school or above. There were slightly more female responders (51.9%) than nonresponders (47.0%) to the questionnaire. Impact of FGIDs on Quality of Life We compared subjects who met criteria for any FGID (n ⫽ 1006) with those who did not meet criteria for any FGID (n ⫽ 1904) on the mental and physical subscales derived from the SF-12. The mean scores for mental and physical components on the SF-12 for our control group (i.e., those who did not meet criteria for any FGID), were 48.1 and 51.6, respectively. The means scores are shown in Table 1, where the lower the score is indicative of more impairment in quality of life. Having an FGID was significantly associated with impaired mental and physical functioning, except for mental functioning in those persons with rumination syndrome and aerophagia, and physical functioning for persons reporting dyschezia. All disorders grouped with respect to anatomic region were significantly associated with reduced mental and physical functioning when compared with controls (Table 2). By stepwise logistic regression, impaired mental func-
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GI Disorders and Quality of Life
Table 1. Mean Scores on Mental and Physical Functioning From the SF-12 for Functional Gastrointestinal Disorders Diagnosis Present FGID
Mental
Physical
Globus (n ⫽ 107) Rumination Syndrome (n ⫽ 25) Functional chest pain (n ⫽ 146) Functional heartburn (n ⫽ 403) Functional dysphagia (n ⫽ 81) Functional dyspepsia (n ⫽ 246) Aerophagia (n ⫽ 60) Irritable bowel syndrome (n ⫽ 127) Functional abdominal bloating (n ⫽ 325) Functional constipation (n ⫽ 227) Functional diarrhea (n ⫽ 237) Functional abdominal pain syndrome (n ⫽ 299) Gallbladder dysfunction (n ⫽ 136) Functional incontinence (n ⫽ 57) Proctalgia fugax (n ⫽ 57) Dyschezia (n ⫽ 40)
41.61* 43.92 41.69* 41.69* 42.61* 43.06* 44.06 41.54* 42.63* 40.98* 43.05* 43.29*
46.93* 43.88* 47.10* 47.10* 44.24* 45.18* 46.61* 44.76* 46.04* 47.37* 47.15* 44.95*
43.39* 43.23 40.57* 40.39*
45.62* 44.36* 46.11* 47.67
* p ⬍ 0.05 for having FGID diagnosis versus no FGID diagnosis (univariate analyses).
tioning (odds ratio [OR] ⫽ 0.95, 95% confidence intervals [CI] ⫽ 0.94, 0.96) and physical functioning (OR ⫽ 0.95, 95% CI 0.94, 0.96) were significantly associated with the probability of having any FGID. However, impairment in mental and physical functioning only explained 3.5% and 3.2% of the deviance, respectively. The association of impaired quality of life with a diagnosis of FGID remained significant after controlling for the effects of neuroticism and symptom severity (abdominal pain and bowel dysfunction) in our final model (mental functioning OR ⫽ 0.98, 95% CI 0.96, 0.99 and physical functioning OR ⫽ 0.96, 95% CI 0.95, 0.98). Health Care Seeking for FGIDs and Quality of Life The majority of persons with a FGID had consulted a physician for symptoms over the past 12 months. Quality of life as assessed by both mental and physical functioning from the SF-12 was significantly impaired in persons consulting for any FGID and for anorectal disorders (Table 3) compared with nonpatients. When grouped according to Table 2. Mean Scores for Mental and Physical Functioning on the SF-12 for Functional Gastrointestinal Disorders According to Anatomic Region Diagnosis Present FGID
Mental
Physical
Esophageal disorders (n ⫽ 573) Gastroduodenal disorders (n ⫽ 274) Bowel disorders (n ⫽ 585) Biliary disorders (n ⫽ 136) Anorectal disorders (n ⫽ 164) Any FGID (n ⫽ 1006)†
43.91* 42.81* 42.73* 43.29* 41.90* 43.9*
47.13* 45.67* 51.03* 44.95* 46.15* 47.7*
* p ⬍ 0.05 for having a FGID diagnosis versus no FGID diagnosis. † Note that numbers in total do not equal numbers in individual diagnostic categories because of overlap.
69
anatomic region, physical functioning was significantly impaired in patients versus nonpatients except for those with biliary disorders. For specific FGIDs, mental functioning was significantly reduced in patients with functional incontinence, functional chest pain, and functional dysphagia (Table 4). Physical functioning was poorer in patients for the following FGIDs: functional heartburn, functional dyspepsia, irritable bowel syndrome, functional abdominal bloating, functional diarrhea, and functional abdominal pain syndrome. By stepwise logistic regression, impaired mental functioning (odds ratio [OR] ⫽ 0.96, 95% CI ⫽ 0.95, 0.97) and physical functioning (OR ⫽ 0.95, 95% CI 0.94, 0.96) were significantly associated with the probability of seeking health care for any FGID. However, impairment in mental and physical functioning only explained 2.7% and 3.9% of the deviance, respectively. The effect of quality of life on seeking health care for a FGID remained significant after controlling for the effects of neuroticism and symptom severity in our final model (mental functioning OR ⫽ 0.98, 95% CI 0.96, 0.99 and physical functioning OR ⫽ 0.96, 95% CI 0.94, 0.97). Controls Versus Nonconsulters With a FGID Univariate analyses showed that nonpatients with a FGID versus controls were significantly more impaired in terms of both mental functioning (mean scores 44.9 and 48.1, respectively) and physical functioning (mean scores 50.5 and 51.6, respectively).
DISCUSSION We examined for the first time the impact of all the FGIDs on quality of life. The prevalence of the FGIDs in this study (34.6%) was substantially lower than that reported in the US householder survey (70.1%). This may be due to our strict application of the 3-month requirement for symptom duration as specified in the Rome I criteria. We found that quality of life in terms of mental or physical functioning as measured by the SF-12 was significantly impaired in the majority of the FGIDs. Patients with a FGID had significant impairment in both mental and physical functioning compared with nonpatients, although the latter were more impaired than healthy controls. For the individual disorders, physical rather than mental functioning tended to be significantly more impaired in patients than nonpatients. Our results confirm previous findings that patients with specific FGIDs such as IBS, functional dyspepsia and functional constipation have a reduced quality of life (6 –11). Talley et al. using the SF-36 found patients with functional dyspepsia to have poorer mental health, social functioning, and health perception compared with healthy controls and patients with other disease (10). Similarly, Whitehead et al. using the SF-36 found that patients with IBS had a greater impairment in functioning than nonpatients, who, in turn, were more impaired than controls (6). This association re-
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Koloski et al.
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Table 3. Mean Scores on Mental and Physical Functioning From the SF-12 for Patients Versus Nonpatients According to Anatomic Region FGID (n) Esophageal disorders (573) Gastroduodenal disorders (274) Bowel disorders (585) Biliary disorder (136) Anorectal disorders (164) Any FGID (1006)
Patients
Nonpatients
Patients (n)
Mental
Physical
Mental
Physical
311 201 340 106 82 625
44.12 43.03 42.39 43.88 40.24 43.29
45.04 44.42 45.23 44.92 43.90 46.0
43.65 42.22 43.20 43.40 43.56* 44.9*
49.64* 49.07* 49.87* 48.04 48.39* 50.5*
* p ⬍ 0.05 for patients versus nonpatients.
mained significant when the confounding effects of neuroticism and psychological distress were controlled for in the analyses (6). Impairment in quality of life as a predictor of health care seeking for any FGID also remained significant in our study after the effects of neuroticism were taken into account. Controlling for symptom severity in the present study did not alter the impact of mental and physical functioning in those persons who had a FGID diagnosis. Thus, we conclude that impairment in quality of life appears to drive health care seeking behavior for FGIDs in general, although this explains only a very small amount of health care seeking behavior. The strengths of our study included the use of a random population sample, examination of quality of life for all the FGIDs, and the use of a valid quality of life measure, the SF-12 (20). Limitations with previous studies and ours, however, include the use of a general rather than a diseasespecific measure of quality of life that may not sensitively measure the impact of all the functional disorders of the gastrointestinal tract. For example, IBS have been found to negatively affect psychological well-being (21–23): for example, the fear of not being able to have a bowel movement (24). However, specific measures of quality of life for all the FGIDs are currently unavailable and a generic measure
allows the impact of all the disorders to be directly compared. The development of the IBSQOL, a measure to assess quality of life in persons with IBS, represents one attempt to overcome the limitations of using generic measures (24). Hahn et al. (9), using this measure, found that IBS patients who perceived their symptoms to be very severe had reduced scores on quality of life indices including physical and emotional role, vitality, sexual relations, sleep, social functioning, mental health, and diet (9). Similarly, Patrick et al. identified lower scores on the IBSQOL subscales of interference with activity, food avoidance, and health worry in a sample of IBS patients (24). The recent development of the functional digestive disorders quality of life questionnaire is proving to be a valuable tool for measuring the physical, psychological, and perceptual ramifications of both IBS and functional dyspepsia (25). This study has provided important new information on the impact of all the FGIDs on quality of life. Further understanding of the impact of these disorders on quality of life should help with the planning of appropriate interventions for this condition. Because these disorders are not typically associated with significant mortality and morbidity, measuring quality of life may provide a more suitable
Table 4. Mean Scores on Mental and Physical Functioning From the SF-12 for Patients Versus Nonpatients FGID (n) Globus (107) Rumination Syndrome (25) Functional chest pain (146) Functional heartburn (403) Functional dysphagia (81) Functional dyspepsia (246) Aerophagia (60) Irritable bowel syndrome (127) Functional abdominal bloating (325) Functional constipation (227) Functional diarrhea (237) Functional abdominal pain syndrome (299) Gallbladder dysfunction (136) Functional incontinence (57) Proctalgia fugax (57) Dyschezia (40) * p ⬍ 0.05 for patients versus nonpatients.
Patients
Nonpatients
Patients (n)
Mental
Physical
Mental
Physical
47 6 92 197 35 186 25 103 159 98 109 227 100 30 18 20
41.65 41.31 43.36 44.91 42.61 43.56 44.48 41.50 43.09 40.28 42.05 43.35 43.38 40.68 38.88 40.05
46.23 42.87 45.67 43.90 44.24 44.10 43.77 43.59 43.62 45.99 44.71 43.77 44.92 43.13 43.35 45.69
41.57 44.74 38.77* 43.57 46.77* 41.54 43.77 41.72 42.19 41.49 43.88 43.10 43.40 45.67* 41.35 40.73
47.48 44.20 49.57* 50.21* 50.71* 48.49* 48.67 49.78* 48.36* 48.39 49.21* 48.66* 48.04 47.11 47.38 49.65
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way of judging the efficacy of current treatments. Future research in this area may benefit from the development of a general functional GI disorder quality of life instrument that incorporates the full spectrum of activities and areas in life that are likely to be affected by all of these disorders.
ACKNOWLEDGMENT Supported by a research grant from the National Health and Medical Research Council of Australia. Reprint requests and correspondence: Nicholas J. Talley, M.D., Department of Medicine, Clinical Sciences Building, Nepean Hospital, P.O. Box 63, Penrith NSW 2751, Australia. Received May 17, 1999; accepted Sep. 7, 1999.
GI Disorders and Quality of Life
10. 11. 12. 13.
14. 15.
REFERENCES 1. Guyatt GH, Veldhuyzen Van Zanten SJO, Feeny DH, et al. Measuring quality of life in clinical trials: a taxonomy and review. Can Med Assoc J 1989;140:1441– 8. 2. Guyatt GH. Measuring quality of life: A review of means of measurement in clinical trials of new medicines, Pharmaceut Med 1987;2:49 – 60. 3. Dimenas E, Glise H, Hallerback B, et al. Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens? Scand J Gastroenterol 1993; 28:681–7. 4. Drossman DA, Richter JE, Talley NJ, et al., eds. The functional gastrointestinal disorders. Diagnosis, pathophysiology and treatment—A multinational consensus. Boston: Little, Brown, 1994. 5. Drossman DA, Li Z, Andruzzi E, et al. U.S. householder survey of functional gastrointestinal disorders: Prevalence, sociodemography and health impact. Dig Dis Sci 1993;38: 1569 – 80. 6. Whitehead WE, Burnett CK, Cook III EW, et al. Impact of irritable bowel syndrome on quality of life. Dig Dis Sci 1996; 41:2248 –53. 7. O’Keefe EA, Talley NJ, Zinsmeister AR, et al. Bowel disorders impair functional status and quality of life in the elderly: A population-based study. J Gerontol Med Sci 1995;50A: M184 –9. 8. McGee HM, O’Boyle CA, Hickey A, et al. SEIQoL with a healthy and a gastroenterology population. Psychol Med 1991; 21:749 –59. 9. Hahn BA, Kirchdoerfer LJ, Fullerton S, et al. Patient perceived severity of irritable bowel syndrome in relation to
16. 17. 18.
19. 20. 21. 22. 23.
24. 25.
71
symptoms, health resource utilization and quality of life. Aliment Pharmacol Ther 1997;11:553–9. Talley NJ, Weaver AL, Zinsmeister AR. Impact of functional dyspepsia on quality of life. Dig Dis Sci 1995;40:584 –9. Glia A, Lindberg G. Quality of life in patients with different types of functional constipation. Scand J Gastroenterol 1997; 32:1083–9. Australian Bureau of Statistics: 1991 Census of population and housing, basic community profile: Area 6350 Penrith, ABS catalogue No. 2722.1. Koloski NA, Talley NJ, Boyce PM. High prevalence and striking overlap of the functional gastrointestinal disorders (FGIDs): Is the current Rome classification worthwhile? Gastroenterology 1999;116:A305. Koloski NA, Talley NJ, Boyce PM. High levels of health care utilization for functional gastrointestinal disorders (FGIDs) in a community. Gastroenterology 1999;116:A4427. Koloski NA, Talley NJ, Boyce PM. Psychological mechanisms are linked to the pathophysiology of the functional gastrointestinal disorders and not just health care seeking. Gastroenterology 1999;116:A4428. Grayson DA. Latent trait analysis of the Eysenck Personality Questionnaire. J Psychiatry Res 1986;20:217–35. Bedford A, Foulds GA. Validation of the Delusions-Symptoms-States Inventory. Br J Med Psychol 1977;50:163–71. Hadzi-Pavlovic D, Hickie I, Ricci C. The Sphere. Somatic and psychological health report. Development and Initial Evaluation. Technical Report TR-97-002, School of Psychiatry, University of NSW and Academic Department of Psychiatry at St George Hospital, 1997. Ware JE, Kosinski M, Keller SD. SF-12: How to score the SF-12 physical and health summary scales. The Health Institute, New England Medical Center, Boston, MA, 1993. Ware JE, Kosinski M, Keller SD. A 12-item short-form health survey. Construction of scales and preliminary tests of reliability and validity. Med Care 1995;34:220 –3. Talley NJ, Phillips SF, Bruce B, et al. Multisystem complaints in patients with the irritable bowel syndrome and functional dyspepsia. Eur J Gastroenterol Hepatol 1991;3:71–7. Zighelboim J, Talley NJ. What are functional bowel disorders? Gastroenterology 1993;104:1196 –1201. Drossman DA, M Kee DC, Sandler RS, et al. Psychosocial factors in the irritable bowel syndrome. A multivariate study of patients and non-patients with irritable bowel syndrome. Gastroenterology 1988;95:701– 8. Patrick DL, Drossman DA, Frederick IO, et al. Quality of life in persons with irritable bowel syndrome. Development and validation of a new measure. Dig Dis and Sci 1998;43:400 –11. Chassany O, Marquis P, Scherrer B. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut 1999;44:527–33.