The effects of thiopurine therapy on health-related quality of life in Inflammatory Bowel Disease patients Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn’s Disease in a Randomized Single-Blinded Placebo Controlled Study The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX® formulated delayed-release mesalamine Measurement of health status. Ascertaining the minimal clinically important difference. Effects of a comprehensive lifestyle modification program on quality-of-life in patients with ulcerative colitis: A twelve-month follow-up Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. Health-Related Quality of Life and Pouch Function in Continent Ileostomy Patients: A 30-Year Perspective Cyclosporine in severe ulcerative colitis refractory to steroid therapy. Long-Term Outcome After Ileal Pouch-Anal Anastomosis: Function and Health-Related Quality of Life Short Form 36 (SF-36) health survey: normative data from the general Norwegian population Impact of a nurse-led counselling service on quality of life in patients with inflammatory bowel disease. [Population reference values of the Spanish version of the Health Questionnaire SF-36]. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. A prospective evaluation of health-related quality of life after ileal pouch anal anastomosis for ulcerative colitis Psychological Factors Are Associated with Changes in the Health-related Quality of Life in Inflammatory Bowel Disease
Background The effect of thiopurine immunomodulators on health-related quality of life ( HRQoL ) in patients with inflammatory bowel disease ( IBD ) has been controversial . The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines  and assess the short- and long-term impacts of the treatment on HRQoL. Methods Ninety-two consecutive patients who started treatment with thiopurines were prospect ively included . Evaluation of HRQoL was performed at months 0 , 6 , and 12 using two question naires , the Short-Form Health Survey ( SF-36 ) and the Inflammatory Bowel Disease Question naire ( IBDQ ) . Results Baseline score of IBDQ was 4,6 , range ( 2,31 - 6,84 ) , with an impairment of the five dimensions of HRQoL compared with inactive patients . Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population . At 6 months patients had a significant improvement in overall IBDQ score -5,8 ( 1,58 -6,97)- and also in all IBDQ dimensions . All the 8 dimensions of SF-36 obtained a significant improvement . At twelve months score of IBDQ was 6,1 , range ( 2,7 - 6,98 ) , with improvement in all dimensions compared with baseline and 6 months . SF-36 showed a similar significant improvement in all subscales . Conclusions Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients Background Ingestion of And oSanTM , based on the mushroom Agaricus blazei Murill , has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn ’s disease ( CD ) . In this r and omized single-blinded placebo-controlled study we examined whether intake of And oSanTM also result ed in clinical effects . Methods and Findings 50 patients with symptomatic CD were r and omized for oral daily consumption of And oSanTM or placebo for a 21-day experimental period , in this per- protocol study . Patients reported vali date d scores for symptoms , fatigue and health related quality of life ( HRQoL ) at days 0 , 14 and 21 . Fecal calprotectin and general blood parameters were also analyzed . In the And oSanTM group ( n = 25 ) symptoms improved from baseline ( day 0 ) to days 14 and 21 , with respective mean scores ( 95 % CI ) of 5.52 ( 4.64–6.40 ) , 4.48 ( 3.69–5.27 ) and 4.08 ( 3.22–4.94 ) ( p<0,001 ) . We found significant improvements in symptom score for both genders in the And oSanTM group , and no significant changes in the placebo ( n = 25 ) group . There were however no significant differences between the groups ( p = 0.106 ) , although a marginal effect in symptom score for men ( p = 0.054 ) . There were comparable improvements in physical , mental and total fatigue for both groups . HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the And oSanTM group and for vitality and social functioning in the placebo group . No crucial changes in general blood sample s and fecal calprotectin were detected . Conclusions The results from this single-blinded r and omized clinical trial shows significant improvement on symptoms , for both genders , in the And oSanTM group , but no significant differences between the study groups . The results on fatigue , HRQoL , fecal calprotectin and blood sample s were quite similar compared with placebo . The patients did not report any harms or unintended effects of And oSanTM . CD patients with mild to moderate symptoms may have beneficiary effects of And oSanTM as a safe supplement in addition to conventional medication . Trial Registration Clinical Trials.gov Purpose Ulcerative colitis ( UC ) is associated with impaired health-related quality of life ( HRQL ) and work-related outcomes ( WRO ) . This analysis examined correspondences among measures of HRQL and WRO in patients with UC , as well as the magnitude of each measure ’s responsiveness to disease activity and treatment . Methods An open-label , prospect i ve trial of delayed-release mesalamine tablets formulated with MMX ® technology included 8 weeks of treatment for patients with active mild-to-moderate UC ( n = 137 ) and 12 months of maintenance treatment for patients with quiescent UC ( n = 206 ) . Spearman correlations ( ρ ) measured inter-domain associations across measures of generic HRQL [ 12-item Short-Form Health Survey ( SF-12v2 ) ] , disease-specific HRQL [ Short Inflammatory Bowel Disease Question naire ( SIBDQ ) ] , and disease-specific WRO [ Work Productivity and Activity Impairment for Specific Health Problems ( WPAI : SHP ) ] . Responsiveness to disease activity and treatment was assessed for each instrument . Results Changes in scores from baseline to week 8 were moderately correlated across all instrument domains : 65 of 80 ( 81 % ) between-instrument inter-domain correlations were of moderate magnitude ( 0.30 < ρ < 0.70 ) , with an average magnitude of 0.42 [ 95 % confidence interval ( CI ) 0.38–0.46 ] . Associations between symptom measures were stronger for SIBDQ ( |average ρ| = 0.41 ; 95 % CI 0.34–0.48 ) and WPAI : SHP ( 0.40 ; 0.30–0.47 ) than SF-12v2 ( 0.30 ; 0.27–0.34 ) . SIBDQ was most sensitive to treatment [ effect size ( dz ) for change from baseline to week 8 = 0.62 ; 95 % CI 0.35–0.89 ] , followed by WPAI : SHP ( dz = 0.43 ; 0.32–0.54 ) and SF-12v2 ( dz = 0.33 ; 0.27–0.39 ) . Conclusion While the SIBDQ showed the greatest overall responsiveness to disease activity and treatment , all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Objective . To analyze the effects of a comprehensive lifestyle modification program on health-related quality -of-life , psychological distress , and clinical parameters in patients with ulcerative colitis ( UC ) 3- and 12 months after completion of the program . Material and methods . Sixty patients with UC in clinical remission or with low disease activity were r and omly assigned to an intervention group or a usual-care control group . Comprehensive lifestyle modification consisted of a structured 60-h training program over a period of 10 weeks which included stress management training , psychoeducational elements , and self-care strategies .  Quality -of-life , psychological distress , and clinical disease activity were assessed with st and ardized question naires ( Inflammatory Bowel Disease Question naire ( IBDQ ) ; the MOS Short-Form 36 ( SF-36 ) ; the Brief Symptom Inventory ( BSI ) , and the Colitis Activity Index ( CAI ) ) at baseline , and 3 months and 12 months after comprehensive lifestyle modification . Results . Three months after comprehensive lifestyle modification , patients in the intervention group showed significantly greater improvement in the SF-36 scale physical function ( p=0.0175 ) , and a significantly greater reduction in anxiety scores , measured with the BSI ( p=0.0294 ) . Use of relaxation techniques was a significant predictor of improvement in the psychological sum score after 3 months of therapy ( p=0.034 ) . Though 80 % of patients with an initial IBDQ score < 170 in the intervention group showed an improvement of > 16 points after 3 months , no significant effects of the intervention were found on the IBDQ scales , or on clinical disease parameters , including CAI scores , self-assessed disease activity , hospitalizations , or medical consultations . Conclusions . These results are consistent with possible short-term benefits of a comprehensive lifestyle modification program on some aspects of quality -of-life and emotional well-being , but no effects were discernable 12 months after completion of therapy . Comprehensive lifestyle modification had no effect on clinical disease variables . The generalizability of these data is limited because of the inclusion of patients with a relatively low disease activity who were interested in integrative medicine OBJECTIVES --To gain population norms for the short form 36 health survey question naire ( SF36 ) in a large community sample and to explore the question naire 's internal consistency and validity . DESIGN --Postal survey by using a booklet containing the SF36 and several other items concerned with lifestyles and illness . SETTING --The sample was drawn from computerised registers of the family health services authorities for Berkshire , Buckinghamshire , Northamptonshire , and Oxfordshire . SAMPLE --13,042 r and omly selected subjects aged 18 - 64 years . MAIN OUTCOME MEASURES --Scores for the eight health dimensions of the SF36 . RESULTS --The survey achieved a response rate of 72 % ( n = 9332 ) . Internal consistency of the different dimensions of the question naire was high . Normative data broken down by age , sex , and social class were consistent with those from previous studies . CONCLUSIONS --The SF36 is a potentially valuable tool in medical research . The normative data provided here may further facilitate its validation and use PURPOSE The principal aim of this study was to assess long-term pouch durability and health-related quality of life in an original series of patients operated on with a continent ileostomy . PATIENTS Data from 68 of 88 patients who had a continent ileostomy performed at Sahlgrenska University Hospital between 1967 and 1974 were analyzed . Median age at follow-up was 60 ( range , 40–89 ) years and median follow-up was 31 ( range , 29–36 ) years . METHODS Patients were sent a question naire on pouch function along with the Short Form-36 Health Survey 2.0 . A r and om age-matched and gender-matched sample was drawn from the Swedish national Short Form-36 Health Survey norm data base to compare with the patient group . RESULTS The majority of the patients reported good physical condition and satisfactory pouch function . Patients evacuated the pouch a median of four times every 24 hours . Twelve patients ( 18 percent ) had leakages . Forty-four patients ( 65 percent ) had had at least one postoperative revision to restore continence . Generally minor peristomal skin irritation occurred in seven patients ( 10 percent ) . Patients with concurrent complaints ( mostly age related ) reported poorer health-related quality of life . Nevertheless , 78 percent of the patients rated their overall health as good , very good , or excellent . The patients ’ Short Form-36 Health Survey scores were comparable to reference values . CONCLUSIONS Although revisional operations may be needed to restore continence , continent ileostomy has a good durability . Pouch function was satisfactory and patients ’ satisfaction was high . Health-related quality of life levels were similar to those of the general population BACKGROUND There has been no new effective drug therapy for patients with severe ulcerative colitis since corticosteroids were introduced almost 40 years ago . In an uncontrolled study , 80 percent of 32 patients with active ulcerative colitis refractory to corticosteroid therapy had a response to cyclosporine therapy . METHODS We conducted a r and omized , double-blind , controlled trial in which cyclosporine ( 4 mg per kilogram of body weight per day ) or placebo was administered by continuous intravenous infusion to 20 patients with severe ulcerative colitis whose condition had not improved after at least 7 days of intravenous corticosteroid therapy .  A response to therapy was defined as an improvement in a numerical symptom score ( 0 indicated no symptoms , and 21 severe symptoms ) leading to discharge from the hospital and treatment with oral medications . Failure to respond to therapy result ed in colectomy , but some patients in the placebo group who had no response and no urgent need for surgery were subsequently treated with cyclosporine . RESULTS Nine of 11 patients ( 82 percent ) treated with cyclosporine had a response within a mean of seven days , as compared with 0 of 9 patients who received placebo ( P < 0.001 ) . The mean clinical -activity score fell from 13 to 6 in the cyclosporine group , as compared with a decrease from 14 to 13 in the placebo group . All five patients in the placebo group who later received cyclosporine therapy had a response . CONCLUSIONS Intravenous cyclosporine therapy is rapidly effective for patients with severe corticosteroid-resistant ulcerative colitis Purpose This study was design ed to investigate long-term pouch function and health-related quality of life in a single , large cohort of patients with ileal pouch-anal anastomosis for ulcerative colitis . Methods Data from 370 patients were included in the study . Thirty-nine patients ( 11 percent ) did not have a functioning pouch ( failures ) but were included in the health-related quality of life analyses .  Pouch function ( Öresl and score ) and health-related quality of life ( Short Form-36 ) were evaluated by postal question naires . A total of 88 percent of the patients with a functioning ileal pouch-anal anastomosis returned the question naires vs. 76 percent of the failures . Median follow-up time after ileal pouch-anal anastomosis was 15 years vs. 11 years after failure . An age-matched and gender-matched reference sample ( n = 286 ) was r and omly drawn from the Swedish Short Form-36 data base . Results Median bowel frequency was six per 24 hours : 76 percent emptied the reservoir at night , 23 percent had urgency , 12 percent had evacuation difficulties , and 17 percent experienced soiling during the day . Fifty-two percent of the males and 32 percent of the females suffered from soiling at night . More than one-half of the patients had occasional perianal soreness , 6 percent considered the pouch to be a social h and icap , and 94 percent were satisfied with their pouch . Patients with a functioning ileal pouch-anal anastomosis did not differ from the reference sample on any Short Form-36 domain , except for a reduced score in General Health ( P = 0.02 ) . Pouch function was positively correlated to health-related quality of life .  Patients with pouch failure had reduced health-related quality of life in most domains . Conclusions Patients ’ satisfaction is high and functional outcome is good after ileal pouch-anal anastomosis . Poor pouch function affects health-related quality of life negatively . Patients with failure after ileal pouch-anal anastomosis are substantially limited in a variety of health-related quality of life domains Anchoring  health-related quality of life ( HRQOL )  measures in population norms makes clinical interpretations more meaningful and is in accordance with practice in other fields of medicine . In this paper norms for the  Short Form 36 ( SF-36 ) are presented in a r and om sample , representative of the general Norwegian population . In addition , sociodemographic variables affecting the scale scores are explored and discussed . The response rate was 67 % , being lowest among subjects aged 70 years or over .  Data -completeness strongly declined with increasing age . Physical health scales were also strongly affected by age . In all scales , with the exception of general health perceptions , women reported having poorer health than men . Marital status affected the four mental health scales . Educational status affected all the scales , but the effect was smallest in the mental scales . These norms can be employed for comparison in case-control studies , or to interpret HRQOL changes in prospect i ve studies . Differences in social status should be given special attention . Caution should be exercised when assessing subjective health or employing the norms among subjects aged 70 years or over AIM Health related quality of life is impaired in patients suffering from inflammatory bowel disease . Although counselling directed towards physical and psychological morbidity is assumed to improve health related quality of life , this has never been demonstrated . METHODS Physical and psychological well-being were assessed using question naires administered to 100 out- patients in the United Kingdom suffering from inflammatory bowel disease , 50 subjects not suffering from inflammatory bowel disease and a disease control group comprising 28 patients with psoriatic arthritis . A specific nurse led counselling package was given to half the inflammatory bowel disease group and health related quality of life was assessed at baseline , 6 and 12 months . RESULTS Inflammatory bowel disease and psoriatic arthritic patients had a range of physical disease activity , although none were severely ill during the course of the study . Medical therapy was similar in both groups throughout the duration of the trial . The mean Short Form 36 ( SF-36 ) scores for mental health were low in inflammatory bowel disease patients ; 62.9 + /- 9.1 ( SD ) in ulcerative colitis , 60 + /- 9.8 ( SD ) in Crohn 's disease , compared with 72.4 + /- 7.2 ( SD ) in healthy controls ( P < 0.05 ) . Mean SF-36 scores for social function were also reduced in Crohn 's disease patients ; 68.4 + /- 10.1 ( SD ) in Crohn 's disease , compared with 87 + /- 10.1 ( SD ) in healthy controls ( P < 0.05 ) . As expected , the mean SF-36 scores in psoriatic arthritic patients were significantly low 61.9 + /- 1.5 ( SD ) compared with 82.4 + /- 14 ( SD ) in healthy controls ( P < 0.05 ) . Crohn 's disease patients were significantly more anxious than the other groups , mean HAD score was 10 + /- 3.7 ( SD ) in Crohn 's disease patients and 6.86 + /- 3.5 ( SD ) in healthy volunteers ( P < 0.05 ) , although mean HAD scores for depression were similar in all groups . Maladaptive coping mechanisms were present in a significant proportion of Crohn 's disease patients . At follow-up all aspects of psychological morbidity returned to the normal range in the Crohn 's disease patients without significant change in the mean physical disease index . CONCLUSION Health related quality of life can be improved over 6 months by provision of a nurse led counselling service but the effects are not sustained for 12 months BACKGROUND Perceived health status measurements reference values an important information source for health services research . Population -based norms have been proposed to increase their interpretability . In this paper , we have obtained the norms of the Spanish version of the SF-36 Health Survey and have compared them with US norms the question naire . MATERIAL AND METHODS Data were obtained in the home interview survey on drug consumption ( February 1996 ) . This is a cross-sectional study of a multi-stage , stratified r and om sample of non-institutionalized individuals 15 and older residents in Spain . The final sample included 9,984 individuals , but the analysis is based on those individuals 18 or older ( n = 9,151 ) .  Personal home interviews were carried out . Information included : the SF-36 , legal and illegal drugs consumption , and socio-demographic data , among others . Central trend and dispersion statistics were estimated for each of the SF-36 dimension scores according to gender and age group . Cronbach 's alpha coefficients were calculated to estimate the reliability of scores . RESULTS For most SF-36 dimensions , scores were higher ( better ) among men and among younger age groups ( p < 0.01 ) . There was a monotonic score gradient by age which was more intense for physical function and bodily pain . All Cronbach 's alpha coefficients were higher than 0.7 ( ranging from 0.78 to 0.96 ) . Spanish norms were very similar to those obtained in the US . CONCLUSIONS Results presented should be considered the population -based norms of the Spanish version of the SF-36 Health Survey and may be useful for interpreting the question naire scores . These norms , which are very similar to the original US question naire both in absolute values and in the gender and age group distribution patterns , should be carefully used . Considerations for use discussed in the paper should be taken into account We assessed oral 5-aminosalicylic acid ( 5-ASA ) prepared with a pH-sensitive polymer coating in 87 patients with mildly to moderately active ulcerative colitis in a double-blind , placebo-controlled trial . Patients were r and omly assigned to receive 5-ASA at a dosage of either 4.8 or 1.6 g per day or placebo for six weeks . The outcome was monitored by flexible proctosigmoidoscopic examinations and physicians ' assessment s at three-week intervals and by patients ' recordings of daily symptoms . Results showed 24 percent complete and 50 percent partial responses in those receiving 4.8 g of 5-ASA per day as compared with 5 percent complete and 13 percent partial responses in those receiving placebo ( P less than 0.0001 , rank-sum test ) . At a dosage of 1.6 g per day , the response was twice as good as with placebo , but the difference did not reach statistical significance ( P = 0.51 ) . Age , sex , duration of disease , duration of active symptoms , or extent of disease did not affect the clinical outcome . We conclude that oral 5-ASA administered in a dosage of 4.8 g per day is effective therapy , at least in the short term , for mildly to moderately active ulcerative colitis OBJECTIVES : The ileal pouch anal anastomosis is a safe and effective procedure but is also associated with pouchitis , small bowel obstruction , and incontinence . We prospect ively evaluated the health-related quality of life using generic and disease-specific measures in a cohort of patients with ulcerative colitis undergoing ileal pouch anal anastomosis .  METHODS : Health-related quality of life  measures included the Time Trade-off , Rating Form of IBD Patient Concerns , and the Short-Form 36 .  Assessment s occurred preoperatively and 1 , 6 , and 12 months postoperatively . RESULTS : Time Trade-off scores had significantly improved at the 1-month postoperative assessment and approached perfect health at the 12-month postoperative assessment . The Rating Form of IBD Patient Concerns revealed a significant reduction in patient concerns at 1 month , and this difference persisted at 6 and 12 months . Seven of the eight subscales of the Short-Form 36 revealed improved health-related quality of life postoperatively . CONCLUSIONS : Health-related quality of life improved after ileal pouch anal anastomosis when assessed with both generic and disease-specific measures . Improvements were observed as early as 1 month postoperatively . These results may guide patients and physicians as they consider and prepare for the impact of ileal pouch anal anastomosis Background : The effect of different sociodemographic and clinical variables on the health-related quality of life ( HRQOL ) of patients with inflammatory bowel disease ( IBD ) is currently known , but the influence of psychological factors has not been sufficiently explored . The objective of this study was to identify psychological predictors of HRQOL in patients with IBD . Methods : A cross-sectional prospect i ve study was undertaken including 875 consecutive IBD patients . Independent variables were measured using a  sociodemographic and clinical question naire , the Hospital Anxiety and Depression Scale ( HADS ) question naire , the Perceived Stress Scale ( PSS ) question naire , and the COPE question naire . Dependent variables were measured using the  Short Form 36 Health Survey ( SF-36 )  and the  Inflammatory Bowel Disease Question naire ( IBDQ-36 ) .  Logistic regression was performed to identify factors associated with HRQOL . Results : The participation rate was 91.3 % . Patients with IBD had a poorer HRQOL than the general population except on the Physical Function , Social Function , and Emotional Function Scale . Moreover , high levels of anxiety , depression , and stress were found to be associated with low levels in all quality of life measurements . No significant relationship was found between HRQOL and coping strategies . Conclusions : In patients with IBD , stress , anxiety and depression are important determinants of HRQOL and should therefore be considered in the management of this patient population
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