Inflammatory Bowel Disease Patient Concerns Research Articles

P365 Correlation between patient-reported outcomes (PROs) and patient-reported disease activity in Ulcerative Colitis (UC): Findings from the ICONIC study

Abstract Background This analysis aimed to examine the correlation of patient-reported outcomes (PROs) with patient-reported disease activity, and to identify individual questions of the Patient Simple Clinical Colitis Activity Index (P-SCCAI) associated with Work Productivity and Activity Impairment (WPAI) questionnaire domains in patients from the ICONIC study.1 Methods ICONIC enrolled unselected outpatients (N=1804) with recent-onset UC.1 Correlations between PRO measures (Rating Form of Inflammatory Bowel Disease Patient Concerns [RFIPC], Patient Health Questionnaire-9 [PHQ-9], and Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) at baseline (visit [V]1) and 2 years (V5) were assessed using Spearman’s rank correlation coefficient. WPAI domains and PHQ-9 were evaluated at V1 and V5 using a multivariable logistic regression model with individual P-SCCAI questions. Results Significantly higher work productivity impairment scores, lower reported quality of life (QoL), and higher worries/concerns at V1 and V5 were observed in patients with active disease (P-SCCAI ≥5) vs inactive disease (P-SCCAI <5) (Figures 1 and 2). A strong correlation (0.70–0.89) was found between the SIBDQ and the P-SCCAI and PHQ-9 (Table 1). WPAI presenteeism, total activity impairment and total work productivity impairment were moderately correlated (0.40–0.69) with P-SCCAI and PHQ-9 (Table 1). At V1, a significant positive association of disease severity and nocturnal bowel urgency was observed with WPAI presenteeism, absenteeism, and total activity impairment. At V1 and V5, lower patient-assessed PHQ-9 scores were significantly associated with female gender, no bowel urgency, and no joint pain. Conclusion These observational data in patients with UC suggest strong correlations between some PRO measures and patient-reported disease activity. Nocturnal bowel urgency was a key driver of total work productivity impairment, suggesting it is an important PRO to monitor when assessing overall patient QoL. Reference

Worries and concerns of inflammatory bowel disease (IBD) patients in Belgium – a validation of the Dutch rating form

Objectives Worry is the most common psychological complaint among patients with Inflammatory Bowel Disease (IBD). This study aimed to translate and test the psychometric properties the Rating Form of IBD Patient Concerns (RFIPC) among Dutch-speaking patients with IBD in Belgium. It also aimed to describe worries and concerns, and to examine possible differences in worry patterns between patients with different disease types and disease activities. Methods The RFIPC was translated into Dutch following the guidelines of the Rome Foundation and was completed by patients with Crohn’s disease (CD, n = 336) and ulcerative colitis (UC, n = 160). To test concurrent validity, the Depression Anxiety Stress Scales (DASS-21) were used. Factor structure was examined with confirmatory factor analysis. Results The four-factor structure including subscales ‘impact of the disease’, ‘sexual intimacy’, ‘complications of the disease’ and ‘body stigma’ was confirmed in the Dutch sample. All factors had high internal consistency (>.70). Correlations with DASS-21 suggest good concurrent validity, all rs>.30, ps<.001. No differences in the RFIPC scores were observed between patients with CD and UC. Patients with active disease (53%) had higher scores than patients in remission (47%). Across all groups, the order of top concerns was consistent and included worries about energy level, side effects of medication, having an ostomy bag/surgery, and uncertain nature of the disease. Conclusions The Dutch version of the RFIPC is a valid and reliable measure of IBD-specific worries and concerns which can be used in both research and clinical settings.

P713 Effects of vedolizumab on health-related quality of life, work productivity and patient concerns in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland: OCTAVO cohort 2

Abstract Background Patients with inflammatory bowel disease (IBD) experience substantial impairment in health-related quality of life (HRQoL), therefore HRQoL endpoints are considered important measures of treatment outcome. OCTAVO evaluated the effects of vedolizumab on HRQoL, work productivity and patient concerns in IBD patients in the UK and Ireland. Methods OCTAVO is an ongoing multicentre, observational study to evaluate the impact of vedolizumab on two cohorts. Cohort 1 examined the impact of vedolizumab on concomitant medications compared with anti-TNFs in biologic naïve patients with ulcerative colitis (UC). Cohort 2 was non-comparative and observed changes in patient reported outcomes (PROs) in patients with UC and Crohn’s disease (CD) prescribed vedolizumab at any point in the treatment pathway. PROs are assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD-Control-8 (IBD-C-8), Work Productivity and Activity Impairment (WAPI) and Rating Form of IBD Patient Concerns (RFIPC). PROs are collected prospectively at baseline, Week 14, 6 months and 12 months post-initiation via online questionnaires. The results of an interim analysis of Week 14 PROs for patients aged ≥18 years newly initiated on vedolizumab enrolled across 7 hospital sites in Cohort 2 are reported here. Results Sixty-one patients (21 CD, 40 UC; 51% male) were recruited, with a median age of 39.0 (IQR 32.0–55.0); and median disease duration of 9.6 years (IQR 1.7–17.2) for CD and 5.6 years (IQR 1.3–17.4) for UC. Mean total SIBDQ scores at Week 14 were: 45.2 for CD; 50.0 for UC. Scores increased by 8.5 points in CD patients and 10.2 points in UC patients in the first 14 weeks of the study. Similarly, improvements in IBD-C-8, WPAI-UC/CD sub-scores and RFIPC were observed in both CD and UC (Table 1). Conclusion Vedolizumab treatment was associated with meaningful improvements in PROs at Week 14. Improvements were seen across all measures (SIBDQ, IBD-C-8, WPAI-CD/UC and RFIPC) and were similar between CD and UC. Further investigation of vedolizumab on PROs in the real world is required to assess impact in the longer-term, the full analysis of OCTAVO at months 6 and 12 will help to provide this.

722 Racial Differences in the Experience of Inflammatory Bowel Disease

INTRODUCTION: In patients with inflammatory bowel disease (IBD), disease-related worries and concerns can have a substantial impact on clinical outcomes. However, most of the existing literature addressing IBD, its treatment, and disease-related concerns is drawn from majority Caucasian populations. This study aims to compare IBD-related worries and concerns among African American (AA) and non-African American (non-AA) patients. METHODS: We performed a cross-sectional study of IBD patients receiving biologic infusion therapy at a large academic medical center using the Rating Form of IBD Patient Concerns (RFIPC, © 1991, Rome Foundation Inc). This validated tool contains 25 items that assess concerns falling within four sub-domains on a scale from 1-100: impact of disease (IOD), sexual intimacy (SI), complications of disease (CD), and body stigma (BS). Total score, sub-domain scores, and individual item scores were compared between AA and non-AA groups using linear regression analysis, adjusting for age and sex. RFIPC used with permission of Mapi Research Trust, Lyon, France: https://eprovide.mapi-trust.org. RESULTS: Of 53 patients included in this preliminary analysis, 17 were AA and 36 were non-AA. AA participants tended to be younger (35.8 vs 45.3) and more predominantly female (71% vs 42%) compared to non-AA participants. Although AA participants tended to report a greater total burden of concerns, the difference was not significant (mean difference 91.75, P 0.65). AA patients had significantly greater concern in BS (mean difference 28.09, P 0.02); while there was a trend toward higher scores in other sub-domains in the AA group, these were not significant. Type 3 fixed effects analysis revealed significant effect of age on sum score (P 0.01) and IOD (P 0.01) and of sex on SI (P 0.05) and BS (P 0.01). CONCLUSION: Our results suggest that AA patients may experience slightly more IBD-related concern than non-AA patients. Although only the difference in concerns related to body stigma was significant, there was a trend toward greater concern in all other subdomains as well as overall concern in the AA group. We predict more significant differences with continued patient enrollment. Our study highlights important issues to discuss with AA patients, particularly relating to hygiene and self-awareness. As the prevalence of IBD in African Americans continues to increase, further research in this area will facilitate delivery of optimal IBD care for this population.

Epidemiological features and disease-related concerns of a large cohort of Italian patients with active Crohn’s disease

Background-AimsThe SOLE study was conducted on a large cohort of Italian patients with moderate-severe Crohn’s disease (CD) to assess epidemiological and disease characteristics and their correlation with disease-related worries, treatment satisfaction and adherence, workability. MethodsThe following tools were used over 12 months to assess:•disease-related worries: Rating Form of Inflammatory Bowel Disease Patient Concerns,•impact on workability: Work Productivity and Activity Impairment-CD,•satisfaction: Treatment Satisfaction Questionnaire for Medication,•adherence: Medication Adherence Rating Scale.Results were correlated with demographic and clinical variables with linear regression models. Results552 patients with active CD (51% men) were recruited. Higher worries were having an ostomy bag and undergoing surgery. Variables associated with a higher RFIPC score included female sex, higher disease activity, lower treatment adherence (p < 0.001), previous surgical treatments (p = 0.003). 60% of patients claimed difficulties with activities of daily living. Lower VAS scores were reported by patients with disease duration >6years; treatment satisfaction/adherence was higher with anti-TNF-α treatment. Decreased hospitalizations during follow-up and improved workability/daily activities occurred with adalimumab, infliximab, azathioprine (p < 0.001). ConclusionWorries included having an ostomy bag, undergoing surgery, developing cancer: conditions significantly associated with worsened disease activity and low treatment adherence. Higher treatment adherence scores/greater workability improvements were observed in patients treated with anti-TNF-α agents.

The Rating Form of IBD Patient Concerns: Translation, Validation, and First Implementation of the Greek Version.

Background. The rating form of IBD patients' concerns (RFIPC) provides a unique assessment of the worries and concerns of inflammatory bowel disease (IBD) patients. Our aims were primarily to validate the Greek version of RFIPC and secondarily to describe the pattern of Greek patients'concerns. Methods. After translating RFIPC, the questionnaire was given to IBD patients at baseline and after 12 weeks. The questionnaire's measuring properties were evaluated based on the consensus-based standards for the selection of health status measurement instruments (COSMIN) recommendations. Premediated factorial structures were tested for goodness of fit with confirmatory factor analysis (CFA). Results. At baseline, 200 patients (94 with Crohn's disease) completed RFIPC. After 12 weeks, the first 100 patients recompleted the questionnaire. CFA results were consistent with a slightly modified than the original factorial structure. Cronbach's α and intraclass correlation coefficients were high. RFIPC scores negatively affected the quality of life. RFIPC was sensitive to detect important changes in patients' condition and was able to discriminate between remission and active disease. Disease activity, full time employment, celibacy, and low education were associated with higher scores. Conclusion. The Greek version of RFIPC is a reliable, valid, and responsive tool to assess Greek IBD patients' concerns.

Fatigue and disease-related worries among inflammatory bowel disease patients in remission; is it a reflection of coexisting IBS-like symptoms? A short report

ObjectivesIrritable bowel syndrome (IBS) like symptoms and fatigue are frequently reported in quiescent inflammatory bowel disease (IBD). We hypothesized that coexisting IBS-like symptoms might be associated with increased levels of fatigue and disease-related worries. MethodsA total of 140 IBD outpatients were assessed. Cut-off for remission was <4 and <3 on the disease activity indices SCDAI and SCCAI. In addition patients on current steroid treatment were excluded. A diagnosis of IBS was based on the Rome criteria. Fatigue was measured with the Fatigue Questionnaire (FQ), disease related worries with the Rating Form of IBD Patient Concerns (RFIPC). ResultsEighty-nine patients fulfilled the criteria for remission. Of these 89 patients, 21 and 30 were IBS positive according to the Rome II and III criteria, respectively. FQ scores were significantly elevated in IBS positive UC patients. Clinical significant differences were also found in relation to RFIPC scores. ConclusionCoexisting IBS-like symptoms among IBD patients in remission are associated with an increased level of fatigue and disease-related worries.

Is patient reported outcome (PRO) affected by different follow-up regimens in inflammatory bowel disease (IBD)? A one year prospective, longitudinal comparison of nurse-led versus conventional follow-up

ObjectiveSpecialist nurses have become increasingly involved in the management of Inflammatory Bowel Disease (IBD). The objectives of this study were to investigate the impact of nurse-led versus conventional follow-up on patient outcomes, such as quality of life, worries and time from relapse to start of treatment. MethodsPatients completed the Short Form 36 (SF-36), Inflammatory Bowel Disease Questionnaire (N-IBDQ) and the Rating Form of IBD Patient Concerns (RFIPC) at baseline and after 1year. Socio-demographic and clinical variables were obtained at V1 and V2. In addition the amount of e.g., relapses, hospitalisations, time from relapse to start of treatment, sick-leave, unscheduled visits or telephone calls was recorded during the follow-up period. ResultsA total of 140 patients were included; ulcerative colitis (UC) n=92, Crohn's disease (CD) n=48, mean age 46.9 and 40.0years old, respectively. One hundred and thirty three patients attended the follow-up after 1year. After 1year there were no differences between the groups in relation to quality of life, worries, amount of relapse, sick-leave, hospitalisations or surgery. Participants in nurse-led follow-up had a significantly (p<0.05) shorter interval from the start of a relapse to the start of treatment. ConclusionsNurse-led follow-up of IBD patients produces PRO results comparable to that of gastroenterologists and may shorten the interval from the beginning of a relapse to the start of treatment.

Concerns and Quality of Life Before Surgery and During the Recovery Period in Patients With Rectal Cancer and an Ostomy

Rectal cancer is the most common reason for a person to undergo ostomy surgery. The aim of this study was to assess concerns and health-related quality of life (HRQOL) before surgery and during the first 6 months following ostomy surgery in the presence of rectal cancer. The sample comprised 57 patients at a university hospital in Gothenburg, Sweden. Their median age was 66 years (range, 30-87); 35 men and 22 women participated in the study. Participants prospectively answered questionnaires preoperatively, and at 1, 3, and 6 months postoperatively. Concerns were assessed using the rating form of the Inflammatory Bowel Disease Patient Concerns, and HRQOL was evaluated using the 36-Item Short Form Health Survey. Results were compared with population norms. Participants expressed concerns associated with developing cancer, being a burden on others, and related to the uncertain nature of disease. Health-related quality of life scores dropped significantly in 6 of 8 domains when preoperative scores were compared to those obtained 1 month postoperatively, but scores improved at 6 months. There were significant differences between preoperative study group scores and population norms on physical and emotional role function, social function, and for mental health domains. Significant differences persisted when population norms were compared to study group scores 6 months following surgery on all these domains except mental health. Participants identified good relations with significant others, social and leisure activities, psychological issues, and health as important for maintaining QOL. Obstacles to maintaining QOL included fatigue, pain, illness-induced limitations in life, and worries over what their new life would entail. Surgical management of rectal cancer raises concerns and profoundly impairs QOL during the first several postoperative months.

Worries and concerns in a large unselected cohort of patients with Crohn's disease

Objective. Disease-related worries constitute an important dimension of patient-reported perception of health status in inflammatory bowel disease (IBD). The Rating Form of IBD Patient Concerns (RFIPC) questionnaire is purported to measure IBD-related worries. This study evaluated the psychometric properties of a Swedish translation of RFIPC in an unselected population of Crohn's disease (CD) patients. The degree and nature of the worries were characterized and predictive factors for outcome of RFIPC and underlying dimensions were identified. Material and Methods. The RFIPC was completed by 447 CD patients in conjunction with regular visits. A physician global assessment of disease activity and four other health-related quality of life (HRQL) questionnaires were used for construct validity. Reliability and responsiveness were evaluated with follow-up visits. Underlying dimension and predictive factors were identified with factor analysis and multiple linear regression analysis. Results. Test-retest reliability was 0.90, correlation with corresponding HRQL measures 0.60–0.80 and responsiveness ratio 0.84. Median RFIPC sum score was lower than in previous studies. Top three concerns were ostomy, energy level and bowel control. Four dimensions were identified in descending order of concern: disease-related complications, daily-life achievements, intimacy, and stigmatization. Predictors of RFIPC score were disease activity, gender, and BMI (p < 0.001–0.008). Conclusions. The Swedish version of RFIPC exhibited an adequate psychometric performance in CD patients, but was less sensitive to change in disease activity. The patients were more concerned about complications and achievement than intimacy and stigmatization. The strongest predictors of more worry were active disease, female gender and higher BMI.

Factor structures of the Swedish Version of the RFIPC: Investigating the Validity of Measurements of IBD Patients' Worries and Concerns.

BackgroundWorries and concerns of patients with IBD comprise an important negative factor in their HRQOL. The Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC) was developed to describe the nature and degree of the worries and concerns of IBD patients. In the original version, the specific issues of worries are divided into four separate factors. These factors provide useful information about HRQOL and the kind of worries and concerns which are most important to the patient. However, the Swedish version of the RFIPC is often scored using a single sum score, implying that all the specific issues of worries stem from a single general worry factor. The aim of this study was to validate the factor structure of the Swedish version of the RFIPC.MethodsA sample consisting of 195 patients with IBD filled out the RFIPC. Confirmatory factor analysis was performed to examine fit of three hypothesized models of factor structure. Spearman’s correlation and Mann-Whitney analysis were used to follow up the results.ResultsThe single-factor model displayed poor fit indices. The four-factor model marked substantive improvement, but still remains inadequate. The final four-factor model permitting correlated error terms between some items displayed the most adequate fit.ConclusionsThe factorial structure of the RFIPC, as suggested in the original version, was able to be replicated with a slight modification in the Swedish version. The separate factors identified in this structure provide more detailed information about the worries and concerns of IBD patients as these components of worries are different related to HRQOL and general health.

Which patients with IBD need psychological interventions? A controlled study

Psychological distress is frequent in inflammatory bowel disease (IBD). Whether there is a need for psychological interventions is unknown. This study investigated the quantity and quality of the need for psychological interventions in IBD as compared to rheumatoid arthritis (RA). In all, 302 patients with IBD and 109 patients with RA answered the ADAPT questionnaire, assessing the need for psychosomatic support (physicians support) and for psychotherapy, the hospital anxiety and depression scale, the SF-36, a questionnaire on social support (SOZU-K22), and the Rating Form of IBD Patient Concerns (IBD patients only). Detailed biomedical data were also assessed. Ninety-three patients with IBD (31%) expressed a need for psychological intervention compared to 14 patients with RA (13%; P < 0.001). Stepwise logistic regression analysis revealed that anxiety (odds ratio [OR] 3.6; 95% confidence interval [CI] 2.2-6.0; P < 0.001), age < or =44 years (OR 2.6; 95% CI 1.5-4.3; P < 0.001) and impaired social support (SOZU-K22 <4.20) (OR 2.0; 95% CI 1.2-3.3; P = 0.009) accounted for this difference. In IBD the need for psychosomatic (physicians) support was associated with worries and concerns about IBD and the need for psychotherapy was associated with worries and concerns about IBD, anxiety, impaired "social functioning" (SF-36), and short disease duration. Patients with IBD express a higher need for psychological interventions than patients with RA due to greater psychosocial restrictions inherent in IBD. The need for psychological interventions was characterized by psychological factors, mainly worries about the disease and anxiety, rather than by medical variables

Evaluation of the Inflammatory Bowel Disease Questionnaire in Swedish patients with Crohn's disease

Objective. Health-related quality of life (HRQoL) is an important measure of inflammatory bowel disease (IBD) health outcome. The Inflammatory Bowel Disease Questionnaire (IBDQ) comprising 32 items grouped into four dimensions is a widely used IBD-specific HRQoL instrument. The purpose of this study was to evaluate the validity, reliability and responsiveness of the Swedish translation of the IBDQ in patients with Crohn's disease (CD). Material and methods. Four hundred and forty-eight patients with CD completed the IBDQ and three other HRQoL questionnaires (Rating Form of IBD Patient Concerns; Short Form-36; and the Psychological General Well-Being Index) in connection with their regular visit at the outpatient clinic. Disease activity was assessed by the physician on a 4-point Likert scale. Thirty-two patients who were stable in remission completed the questionnaires a second time, 4 weeks later. A total of 418 patients repeated all measurements after 6 months. Results. The dimensional scores were highly correlated with other measures of corresponding aspects of HRQoL and were significantly better in remission than in relapse. High test–retest correlations indicated good reliability. Responsiveness was confirmed in patients whose disease activity changed over time. However, high correlations between the dimensions, poor correlations between items within each dimension, and factor analysis all indicated that the original grouping of the items is not valid for Swedish CD patients. Conclusions. Although the Swedish IBDQ has good external validity, reliability and responsiveness for patients with CD, our results did not support the original grouping of the items.

Quality of life in patients undergoing ileal pouch-anal anastomosis at the University of Cincinnati

Background: In 1978, Drs. Fischer and Martin were among the first to preserve anorectal continence and create a pelvic reservoir in adult patients, in what has become the ileal pouch-anal anastomosis (IPAA). Methods: Here we review our institutions’ experience with 379 of these procedures from 1978 to present. To assess the specific health concerns of patients with ulcerative colitis (UC) and familial adenomatous polyposis (FAP) and determine the effects of IPAA on health-related quality of life, we evaluated patients with the SF-36, the Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC), time trade-off questions, and a gamble question. Results: IPAA patients did not differ from the general population in seven of eight general health categories assessed by the SF-36. When compared with the UC population as a whole using the RFIPC they had reduced concerns in almost all areas. In addition, time trade-off and gamble questions indicated that these patients, as a group, are willing to accept a significant risk of dying in order to achieve their results of the IPAA. Conclusions: This high level of satisfaction has led to the referral of patients who would not have otherwise considered a procedure requiring permanent ileostomy.

Cross-cultural variation in disease-related concerns among patients with inflammatory bowel disease

The aim of this work was to study cross-cultural variations in the impact of inflammatory bowel disease (IBD) on health-related quality of life by an international comparison of disease-related concerns. Item and factor scores on the Rating Form of Inflammatory Bowel Disease Patient Concerns and overall mean concern levels were compared by analysis of variance among 2002 IBD patients in eight countries. The overall level of concern varied from 51 out of 100 in Portugal to 19 in Sweden, with intermediate scores for Italy (43), Canada (40), United States (39), France (39), Austria (33), and Israel (25). Having surgery, an ostomy, the uncertain nature of the disease, and medication side effects were each rated among the first five in importance in six countries. Other items varied considerably. For example, concern regarding pain and suffering was high in Israel and low in Portugal, whereas concern over developing cancer was low in Italy. Concern over financial issues and access to high-quality health care were inversely associated with measures of national economic prosperity. 1) Cross-cultural comparisons of patient concerns related to IBD are feasible using translated scales. 2) Reporting tendencies vary greatly; within Europe, patients from southern countries report greater overall concern. 3) The complications and the variable evolution of disease elicit general concern, but the importance of specific issues varies among countries. 4) The reasons for national differences may have social, cultural, and/or economic determinants with relevance to the patient-physician relationship, patient education, and therapeutic decision making.

Cross-cultural variation in disease-related concerns among patients with inflammatory bowel disease

OBJECTIVE: The aim of this work was to study cross-cultural variations in the impact of inflammatory bowel disease (IBD) on health-related quality of life by an international comparison of disease-related concerns. METHODS: Item and factor scores on the Rating Form of Inflammatory Bowel Disease Patient Concerns and overall mean concern levels were compared by analysis of variance among 2002 IBD patients in eight countries. RESULTS: The overall level of concern varied from 51 out of 100 in Portugal to 19 in Sweden, with intermediate scores for Italy (43), Canada (40), United States (39), France (39), Austria (33), and Israel (25). Having surgery, an ostomy, the uncertain nature of the disease, and medication side effects were each rated among the first five in importance in six countries. Other items varied considerably. For example, concern regarding pain and suffering was high in Israel and low in Portugal, whereas concern over developing cancer was low in Italy. Concern over financial issues and access to high-quality health care were inversely associated with measures of national economic prosperity. CONCLUSIONS: 1) Cross-cultural comparisons of patient concerns related to IBD are feasible using translated scales. 2) Reporting tendencies vary greatly; within Europe, patients from southern countries report greater overall concern. 3) The complications and the variable evolution of disease elicit general concern, but the importance of specific issues varies among countries. 4) The reasons for national differences may have social, cultural, and/or economic determinants with relevance to the patient-physician relationship, patient education, and therapeutic decision making.

Instruments for quality of life assessment in patients with inflammatory bowel disease

Background. Health-Related Quality of Life is an important measure of illness perception on the part of the patient. In this review, the current status of the Health-Related Quality of Life assessment in studies concerning inflammatory bowel disease is examined and the various instruments proposed for this purpose are considered and compared. Methods. A search was made of the Medline database, for relevant articles since 1980. Standard criteria were used for including studies for further evaluation. Results. All studies on measuring Health-Related Quality of Life in inflammatory bowel disease patients conclude that the instruments used were valid and reliable assessment tools. Valid instruments that have been proposed for the assessment of health-related quality of life are: the Inflammatory Bowel Disease Questionnaire, the Rating Form of Inflammatory Bowel Disease Patient Concerns, an Inflammatory Bowel Disease-specific questionnaire developed in Cleveland, the Ulcerative colitis and Crohn's disease Health Status Scales and a Disease-specific questionnaire developed in the University of Padova. Conclusions. Assessing health-related quality of life in inflammatory bowel disease patients is an ever-expanding practice, especially in clinical trials. The instruments that, currently, satisfy most demands for simplicity and validity are the Inflammatory Bowel Disease Questionnaire, reflecting primarily disease activity, and the Rating Form of Inflammatory Bowel Disease Patient Concerns which corresponds more to the psychological and social aspects of inflammatory bowel disease from the patient's point of view.

Influence of Sex and Disease on Illness‐Related Concerns in Inflammatory Bowel Disease

Identifying the normal concerns of people with ulcerative colitis and Crohn's disease (CD) facilitates a comprehensive approach to their medical care. Clinically, it can be easily appreciated that the concerns of men and women with inflammatory bowel disease (IBD) may differ and that this may have a substantial impact on both coping and treatment decisions. However, sex differences have received little empirical study. Significant differences between the sexes on the 25 items of the Rating Form of IBD Patient Concerns (RFIPC) were determined in 343 subjects by univariate ANOVA with disease type and sex as factors, correcting for multiple comparisons and covarying for IBD symptom severity. Compared with men, women reported higher levels of IBD symptom severity and higher overall RFIPC scores. Women were more concerned than men about feelings related to their bodies, attractiveness, feeling alone and having children. There was an interaction between disease and sex regarding concern about sexual performance and intimacy. In both cases, men with CD reported less concern than each other comparison group. The illness concerns that differ between sexes are not the most intense concerns in either sex. These results confirm that sex has a significant influence on a number of illness concerns, particularly concerns related to self-image and relationships. The interaction of disease type and sex with respect to concern over sexual performance and intimacy is open to several potential explanations and requires further research. Sex differences should be considered in the treatment of IBD. Specific inquiry into sex-specific concerns may be useful for the clinician. Further research is required to replicate these retrospective findings.

Cross-cultural variation in disease-related concerns among patients with inflammatory bowel disease

OBJECTIVE: The aim of this work was to study cross-cultural variations in the impact of inflammatory bowel disease (IBD) on health-related quality of life by an international comparison of disease-related concerns. METHODS: Item and factor scores on the Rating Form of Inflammatory Bowel Disease Patient Concerns and overall mean concern levels were compared by analysis of variance among 2002 IBD patients in eight countries. RESULTS: The overall level of concern varied from 51 out of 100 in Portugal to 19 in Sweden, with intermediate scores for Italy (43), Canada (40), United States (39), France (39), Austria (33), and Israel (25). Having surgery, an ostomy, the uncertain nature of the disease, and medication side effects were each rated among the first five in importance in six countries. Other items varied considerably. For example, concern regarding pain and suffering was high in Israel and low in Portugal, whereas concern over developing cancer was low in Italy. Concern over financial issues and access to high-quality health care were inversely associated with measures of national economic prosperity. CONCLUSIONS: 1) Cross-cultural comparisons of patient concerns related to IBD are feasible using translated scales. 2) Reporting tendencies vary greatly; within Europe, patients from southern countries report greater overall concern. 3) The complications and the variable evolution of disease elicit general concern, but the importance of specific issues varies among countries. 4) The reasons for national differences may have social, cultural, and/or economic determinants with relevance to the patient-physician relationship, patient education, and therapeutic decision making. (Am J Gastroenterol 2001;96:1822‐1830. © 2001 by Am. Coll. of Gastroenterology)

Evaluation of the RFIPC, a Disease-Specific Health-Related Quality of Life Questionnaire, in Swedish Patients with Ulcerative Colitis

Background: We wanted to characterize a Swedish version of the Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC) with regard to validity, reliability, and responsiveness. Methods: Two hundred and three consecutive patients with ulcerative colitis were studied. Health-related quality of life (HRQOL) was measured with the disease-specific questionnaire, the RFIPC, and a general questionnaire, the Sickness Impact Profile (SIP). Concerns about general well-being were also reported. Disease activity was measured by means of symptom cards, laboratory tests, and two clinical indices for disease activity. Results: Test-retest reliability using Spearman's r (rs) was 0.79, and internal consistency measured with Cronbach's alpha was 0.95. RFIPC had a fair correlation with concerns about general well-being (rs = 0.69, P < 0.001). There was also a stronger correlation with another measure of HRQOL, the overall SIP score (rs = 0.43), than with measures of disease activity such as stool frequency (rs = 0.28) and sigmoidoscopic grading (NS). The group of patients in relapse had a higher RFIPC sum score than patients in remission (P = 0.001). Measures of HRQOL had a low correlation with disease activity and did not respond to changes in disease activity. Conclusion: The Swedish version of the RFIPC is a valid and reliable measure of HRQOL. The SIP and the RFIPC have a good discriminative ability between groups of patients in remission and in relapse. However, they do not seem to be useful in predicting the disease activity or change in disease activity over time in the individual patient.