Health‐related quality of life in patients with inflammatory bowel disease five years after the initial diagnosis

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<ul><li><p>Health-related Quality of Life in Patients with Inflammatory BowelDisease Five Years after the Initial Diagnosis</p><p>T. Bernklev, J. Jahnsen, E. Aadland, J. Sauar, T. Schulz, I. Lygren, M. Henriksen, N. Stray,. Kjellevold, M. Vatn, B. Moum &amp; the IBSEN Study GroupMedical Dept., Rikshospitalet University Hospital, Oslo, Norway; Dept. of Internal Medicine, stfoldCentral Hospital, Fredrikstad, Norway; Dept. of Internal Medicine, Aker University Hospital, Oslo,Norway; Dept. of Internal Medicine, Telemark Central Hospital, Skien, Norway; Dept. of InternalMedicine, Aust-Agder Central Hospital, Arendal, Norway; Dept. of Gastroenterology, Division ofMedicine, Ulleval University Hospital, Oslo, Norway; Dept. of Internal Medicine, Diakonhjemmet,Oslo, Norway; Dept. of Internal Medicine, Telemark County Hospital, Rjukan, Norway; theInflammatory Bowel South-Eastern Norway (IBSEN) Group of Gastroenterologists</p><p>Bernklev T, Jahnsen J, Aadland E, Sauar J, Schulz T, Lygren I, Henriksen M, Stray N, Kjellevold , VatnM, Moum B, the IBSEN Study Group. Health-related quality of life in patients with inflammatory boweldisease five years after the initial diagnosis. Scand J Gastroenterol 2004;39:365373.</p><p>Background: Health-related quality of life (HRQOL) has become an important tool in evaluating patientsatisfaction in inflammatory bowel disease (IBD). So far, few prospective follow-up studies have beendone to identify variables that influence HRQOL. We aimed to identify demographic and clinicalvariables that influence HRQOL 5 years after diagnosis in patients with ulcerative colitis (UC) or Crohndisease (CD) included in a prospective follow-up study from 1990 to 1994 (the IBSEN study). Methods:All patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specificquality-of-life questionnaire translated into Norwegian and validated. We present data from 497 patients(328 UC patients and 169 CD patients, mean age 43.3 years, 48% female). The impact of age, gender,smoking, symptom severity, disease distribution, rheumatic symptoms and surgery on IBD patientsHRQOL was analysed. Results: Women had a reduction in IBDQ total score of 10 points compared tomen, CD patients had a reduction of 7.5 compared to UC patients. The patients with moderate/severesymptoms had a 50 points lower score than the patients without symptoms. The patients with rheumaticsymptoms had a 10 points lower total score than the patients without these symptoms. All differenceswere statistically significant. The multiple regression analysis showed that symptom severity, rheumaticsymptoms and female gender were the strongest predictors of reduction in HRQOL for both diagnosisgroups. Conclusion: IBD symptoms, rheumatic symptoms and female gender have a significant influenceon patients HRQOL as measured by IBDQ. This was confirmed by the regression analysis.</p><p>Key words: Clinical significance; health-related quality of life (HRQOL); inflammatory bowel disease;inflammatory bowel disease questionnaire (IBDQ); IBD symptom severity; regression analysis</p><p>Tomm Bernklev, Sollkkasletta 10, NO-3233 Sandefjord, Norway (fax.47 33 24 94 41, e-mail.tbernkle@c2i.net)</p><p>The inflammatory bowel diseases (IBD), ulcerativecolitis (UC) and Crohn disease (CD), are chronicgastrointestinal disorders with varying severity thataffect young and middle-aged people (16).</p><p>Several different scoring systems are used to classify theseverity of IBD (710). However, these indices pay limitedattention to the patients subjective experiences. Moreover,they have limitations such as poor standardization, disregardfor rigorous validation and poor sensitivity for detectingfunctional disability and psychosocial problems (11). Dataabout patients own experiences, such as physical and socialfunctioning, mental health and working capacity, which arereferred to as health-related quality of life (HRQOL), arenecessary for clinicians and other healthcare providers whendeciding between different treatment options for IBD</p><p>patients. Investigating them has therefore become mandatoryin most clinical studies and they are often included as aseparate outcome measure in intervention trials.</p><p>There are several different questionnaires measuringHRQOL in IBD (1215), and the Inflammatory BowelDisease Questionnaire (IBDQ) is the most commonly used(12, 13, 16). The psychometric properties of the IBDQ arewell described, and the questionnaire has now been translatedinto several languages, including Norwegian, and validated(1723). The IBDQ has also been used in medical interven-tion trials (11, 24, 25) and for evaluating IBD patients whohave undergone surgery (26, 27). However, these clinical datahave mainly been collected from selected patient materials,and often from CD patients only. Thus, no HRQOL data areavailable from population-based cohorts of IBD patients</p><p>ORIGINAL ARTICLE</p><p> 2004 Taylor &amp; Francis DOI 10.1080/00365520310008386</p><p>Scan</p><p>d J </p><p>Gas</p><p>troe</p><p>nter</p><p>ol D</p><p>ownl</p><p>oade</p><p>d fr</p><p>om in</p><p>form</p><p>ahea</p><p>lthca</p><p>re.c</p><p>om b</p><p>y U</p><p>nive</p><p>rsity</p><p> of </p><p>Mel</p><p>bour</p><p>ne o</p><p>n 11</p><p>/16/</p><p>14Fo</p><p>r pe</p><p>rson</p><p>al u</p><p>se o</p><p>nly.</p></li><li><p>followed prospectively over time. A recent paper hasaddressed some of these issues, but the patient data werecollected from a university hospital registry and the patientswere not followed prospectively (28).</p><p>The IBSEN (Inflammatory Bowel South-Eastern Norway)study group has followed an inception cohort of IBD patientsprospectively since 1990. The demographic and clinical data,both at inclusion and at follow-up, have been described indetail (46, 29). Five years after diagnosis, updated demo-graphic and clinical data were collected from all livingpatients, and questionnaires regarding HRQOL were admi-nistered during interviews with the patients in a cross-sectional design. The aim of the present study was todetermine HRQOL in patients with UC and CD, and toinvestigate the impact of demographic and clinical variableson HRQOL.</p><p>Materials and Methods</p><p>Study populationAll newly diagnosed cases of IBD, or possible IBD, between 1January 1990 and 31 December 1993 in four well-definedareas in southeastern Norway (the counties of Oslo, stfold,Telemark and Aust-Agder) were registered by the localdepartments of gastroenterology. To ensure complete ascer-tainment, all 1236 general practitioners and clinicians at the14 hospitals in the four participating counties receivedinformation about symptoms consistent with IBD, and wereinvited to refer all potential cases of UC or CD to the localgastroenterological outpatient clinic. The information wasgiven prior to the start of the study in the form of three writtenreminders. In addition, information about the study waspresented at local meetings with the general practitioners, andall the practising gastroenterologists, internists, surgeons andpaediatricians in the relevant area were informed of the study.The total population of the geographical area was 966,427 on1 January 1992.</p><p>Endoscopy was chosen as the main instrument for diag-nosis and for determining the distribution of the disease in thecolon. A total of 618 cases of UC and indeterminate colitisand 225 cases of CD were diagnosed, which is consistent withthe high incidence reported in other studies in Norway andScandinavia in the 1970s and 1980s. The annual incidencewas similar throughout the study period, indicating completeascertainment (4, 5). At follow-up between 1 and 2 yearslater, the diagnosis was re-evaluated. Ninety-eight percent ofthe patients were available for follow-up. Four percentreceived an uncertain diagnosis at this point because thediagnosis of IBD could not be definitely confirmed (6).</p><p>Five years after the initial diagnosis, the patients wereinvited to make a clinical follow-up visit to their localhospitals. All these cases were reviewed by gastroenterolo-gists, and patients without a confirmed diagnosis of UC or CDwere then excluded, in addition to the patients who had died(30).</p><p>The remaining patients (454 with UC and 200 with CD)were invited to participate in the present HRQOL study. Ofthese, 533 fulfilled the inclusion criteria for definite IBD, gavewritten informed consent and completed the Norwegianversion of the Inflammatory Bowel Disease Questionnaire(N-IBDQ). These patients were also interviewed about theirdisease and were given a clinical examination by a gastro-enterologist.</p><p>Of these 533 patients, five were excluded because theywere below 18 years of age. Twenty-eight patients with UCwere excluded because they had undergone colectomy, and anadditional 3 patients were excluded because of non-compli-ance in completing the questionnaires. Thus, the IBDQ datafrom 497 patients (328 UC and 169 CD) were available foranalysis. Further demographic data are given in Table I.</p><p>Information on the other 121 patients (29 had moved awayfrom the area, 21 were suffering from concomitant seriousdisease or old age, and 71 patients did not respond to theinvitation) who had not attended the follow-up visit was basedon hospital records and telephone interviews.</p><p>Diagnostic criteria and classification of intestinal diseaseUniform methods and diagnostic criteria were used. Theinitial classification of UC and CD was based on symptomsconsistent with IBD for more than 4 weeks, excludinginfections and other acute or chronic non-IBD. The diagnosisof UC was based on the presence of at least three of thefollowing criteria: (1) a history of diarrhoea and/or blood/pusin the stools; (2) macroscopic appearance by endoscopy withcontinuous mucosal inflammation affecting the rectum incontinuity with some or all of the colon; (3) microscopicfeatures on biopsy compatible with UC; (4) no suspicion ofCD at small-bowel X-ray, ileoscopy or biopsy (4).</p><p>The diagnosis of CD was based on the presence of two ormore of the following established criteria (31): (1) typicalclinical features including abdominal pain, diarrhoea andweight loss; (2) macroscopic appearance at surgery orendoscopy: segmental, discontinuous and/or patchy lesionswith or without rectal involvement, discrete or aphthousulcerations, fissuring and penetrating lesions, cobblestone orstrictures; (3) radiological evidence of stenosis in the smallbowel, segmental colitis or findings of fistulae; (4) histo-logical evidence of transmural inflammation or epithelialgranulomas with giant cells.</p><p>The extent and localization of colonic disease were basedon endoscopical findings and characteristic histological signsof inflammation. When the extent of the disease changedduring follow up, the maximum extent of bowel involvementwas recorded. The patients with CD were classified accordingto disease localization; colitis, ilocolitis, ileitis and upper GI,and to the disease behaviour (32).</p><p>Data collectionAll patient data were collected between January 1995 andDecember 1999. The N-IBDQ was self-administered and was</p><p>Scand J Gastroenterol 2004 (4)</p><p>366 T. Bernklev et al.</p><p>Scan</p><p>d J </p><p>Gas</p><p>troe</p><p>nter</p><p>ol D</p><p>ownl</p><p>oade</p><p>d fr</p><p>om in</p><p>form</p><p>ahea</p><p>lthca</p><p>re.c</p><p>om b</p><p>y U</p><p>nive</p><p>rsity</p><p> of </p><p>Mel</p><p>bour</p><p>ne o</p><p>n 11</p><p>/16/</p><p>14Fo</p><p>r pe</p><p>rson</p><p>al u</p><p>se o</p><p>nly.</p></li><li><p>answered by the patients at the hospital before they wereinterviewed and clinically examined by the gastroenterolo-gist. A standardized procedure was followed at all the centres,which allowed the patients to fill in the questionnaire alone inpeace and quiet. Before the patients left the clinic theinvestigator and a nurse checked the questionnaire to ensurethat all questions had been answered.</p><p>Assessment of HRQOL.IBDQ is a disease-specific quality-of-life questionnaire (12). It consists of 32 questions, with atotal score and 4 underlying dimensions; Bowel Function,Emotional Function, Social Function and Systemic Function.The responses are graded on a 7-point Likert scale from 7 (nota problem) to 1 (a very serious problem), giving a possibletotal score range of 224 to 32. The higher the score the betterthe HRQOL. This questionnaire has recently been translatedinto Norwegian (N-IBDQ), validated and published. TheN-IBDQ has five underlying dimensions in contrast to thefour dimensions in the original IBDQ: Bowel Function-I(Stool consistency and pattern, B1), Bowel Function-II(Bowel pain and discomfort, B2), Emotional Function-I(E1), Emotional Function-II (Worries, E2) and Social Func-tion (SF). The differences in dimensional scores between thetwo versions have been discussed in detail in a previouspublication (23)</p><p>Clinical condition questionnaireThe patients were asked about their clinical condition at thevisit. The recall period was the previous 2 weeks. The fourpossible answers were: no symptoms, mild symptoms (do notinterfere with everyday activities), moderate symptoms (dointerfere with everyday activities, may result in sick leave)</p><p>and severe symptoms (unable to carry out everyday activities,on sick leave or hospitalized).</p><p>Other background informationAt the consultation with the gastroenterologist, additionalinformation was recorded, including smoking habits, symp-tom severity, disease distribution according to the Viennaclassification, history of surgery (CD) and rheumatic symp-toms.</p><p>Statistical methodsAll descriptive data are given as means with standarddeviations; median and range are given when appropriate.Box plots are used to visualize symptom categories. Acorrelation analysis (Pearsons) was made between symptomseverity and N-IBDQ scores. Comparisons of quality of lifebetween UC and CD groups were performed using ANCOVA(analyse of covariance) estimating marginal mean scores with95% confidence intervals adjusted for age and gender, asthese covariates are known to influence HRQOL question-naires.</p><p>To adjust for multiple comparisons we used Bonferronismethod.</p><p>In a multiple linear regression analysis (enter method), weinvestigated the impact of demographic and clinical data(independent variables) on the N-IBDQ total and dimensionscores (dependent variables). The analysis was performed forUC and CD separately.</p><p>The significance level was set to 5%; all tests were two-sided. All the statistical analyses were performed with SPSSVersion 11.0 (SPSS, Chicago, Ill., USA) for Windows.</p><p>Table I. Demographic and clinical data. Actual numbers of patients in each category with percentages in parentheses</p><p>n = 6541 n = 5332 n = 4973</p><p>UC (n = 454) CD (n = 200) UC (n = 361) CD (n = 172) UC (n = 328) CD (n = 169)</p><p>Age (mean s) 44.9 (16.4) 37.9 (15.9) 45.1 (15.3) 38.3 (15.6) 45.7 (14.9) 38.6 (15.5)% women 47.3 50 46.2 49.4 47.6 50.9Smokers</p><p>Yes 57 (13) 81 (41) 43 (12) 71 (41) 39 (12) 71 (42)No 395 (86.6) 115 (57) 314 (87) 97 (56) 288 (87.7) 95 (56)Not known 2 (0.4) 4 (2) 4 (1) 4 (2) 1 (0.3) 3 (2)</p><p>SymptomsNone 258 (57) 87 (44) 203 (56) 80 (46) 183 (56) 79 (47)Mild 153 (34) 82 (41) 128 (35) 68 (40) 122 (37) 68 (40)Moderate/severe 34 (7) 31 (15) 30 (9) 24 (14) 23 (7) 22 (13)Not known 9 (2) 0 0 0 0 0</p><p>RelapseYes 316 (70) 150 (75) 251 (70) 125 (73) 231 (70) 123 (73)No 138 (30) 50 (25) 110 (30) 47 (27) 97 (30) 46 (27)</p><p>Extra-intestinal manifestationsYes 171 (38) 93 (47) 137 (38) 80 (47) 124 (38) 80 (47)No 235 (52) 82 (41) 182 (50) 72 (42) 169 (51) 70 (42)Not known 4...</p></li></ul>

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