Patient and physician views on the quality of care for inflammatory bowel disease after one-year follow-up: Results from SOLUTION-2, a prospective IG-IBD study.

BACKGROUND AND AIMS: Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. AIMS AND METHODS: This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLità cUre malatTIe crOniche intestiNali (SOLUTION-1) study. RESULTS: Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the "Continuity of Care" sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians' and patients' perceptions of quality of care, with the former over-rating their performance in "Continuity of Cares" and under-rating "Costs", "Competence", and "Accessibility" sub-domains of the score (p<0.05 for all). CONCLUSION: Perceived quality of care in a large cohort of Italian patients with inflammatory bowel disease remains unchanged after one-year follow-up and was not significantly affected by disease activity or therapeutic interventions. Differences between physicians' and patients' perceptions of quality of care should be taken into account.

Patient and physician views on the quality of care in inflammatory bowel disease: results from SOLUTION-1, a prospective IG-IBD study.

INTRODUCTION: Remarkable differences in quality of care (QoC) might be observed in different countries, affecting quality of life of inflammatory bowel disease (IBD) patients. The aim of this study was to assess patient and physician perceptions of the QoC in Italy. METHODS: A multicentre observational study on the quality of care in IBD (SOLUTION-1) was conducted in 36 IG-IBD (Italian Group for Inflammatory Bowel Disease) centres in Italy. The QUOTE-IBD (Quality of Care Through the Patient's Eyes) questionnaire was administered to IBD patients and to the attending physicians. The Quality Impact (QI) score summarises the QUOTE-IBD questionnaire, and a QI >9 is considered satisfactory. RESULTS: Nine-hundred-ninety-two patients and 75 physicians completed the QUOTE-IBD questionnaire. The patients scored the domains of competence (9.47 vs. 8.55) and costs (9.54 vs. 8.26) higher that the physicians, while information (9.31 vs. 9.43) and continuity of care (8.40 vs. 9.01) were scored lower. The QI score was rated worse by physicians with less experience (<12 years) with regard to competence (8.0 vs. 9.01), courtesy (8.12 vs. 10.0) and autonomy (8.97 vs. 10.0). Physicians considered the cost domain unsatisfactory. CONCLUSIONS: Healthcare was rated as satisfactory overall for Italian patients and physicians. The physicians underestimate their competence and consider the cost of medical management unsatisfactory. The patients are more critical regarding the continuity of care and information. Country-specific data on QoC allow local governments to allocate resources more effectively.

Thrombotic risk in patients undergoing peripheral stem cell apheresis and low-molecular weight heparin prophylaxis pre-apheresis.

Patients undergoing peripheral blood stem cell (PBSC) collection for autologous transplantation may have a greater incidence of thrombosis due to a number of risk factors (RFs). These factors may be related to the patient himself (history of thromboembolism, tumour type and stage, treatment), to the procedure and/or to the mobilizing agents used. In our study of 97 patients, 32 were considered high risk (HR) patients and were therefore treated with a low prophylactic dose of enoxaparin the evening before stem cell apheresis. Neither thrombotic nor hemorrhagic complications were observed, even though pre-apheresis platelet levels were below 50×10(9)l(-1) in 19 procedures.

Cancer in inflammatory bowel disease 15 years after diagnosis in a population-based European Collaborative follow-up study.

AIM OF THE STUDY: To determine the occurrence of intestinal and extraintestinal cancers in the 1993-2009 prospective European Collaborative Inflammatory Bowel Disease (EC-IBD) Study Group cohort. PATIENTS-METHODS: A physician per patient form was completed for 681 inflammatory bowel disease patients (445UC/236CD) from 9 centers (7 countries) derived from the original EC-IBD cohort. For the 15-year follow up period, rates of detection of intestinal and extraintestinal cancers were computed. RESULTS: Patient follow-up time was fifteen years. In total 62/681 patients (9.1%) [41 with ulcerative colitis/21 with Crohn's disease, 36 males/26 females] were diagnosed with sixty-six cancers (four patients with double cancers). Colorectal cancer was diagnosed in 9/681 patients [1.3%] (1 Crohn's disease and 8 ulcerative colitis). The remaining 53 cancers were extraintestinal. There was a higher prevalence of intestinal cancer in the Northern centers compared to Southern centers [p=NS]. Southern centers had more cases of extraintestinal cancer compared to Northern centers [p=NS]. The frequency of all observed types of cancers in Northern and in Southern centers did not differ compared to the expected one in the background population. CONCLUSIONS: In the fifteen-year follow up of the EC-IBD Study Group cohort the prevalence of cancer was 9.1% with most patients having a single neoplasm and an extraintestinal neoplasm. In Northern centers there were more intestinal cancers while in Southern centers there were more extraintestinal cancers compared to Northern centers. In this IBD cohort the frequency of observed cancers was not different from that expected in the background population.

Serological markers are associated with disease course in ulcerative colitis. A study in an unselected population-based cohort followed for 10 years.

OBJECTIVES: Perinuclear anti-neutrophil cytoplasmic antibody (p-ANCA) and anti-Saccharomyces cerevisiae antibody (ASCA) have been proposed as markers for diagnosis and for subtyping of inflammatory bowel disease (IBD). The aim of this study was to investigate the association of p-ANCA and ASCA with a 10-year disease outcome in terms of cumulative rate of colectomy and relapse in a population-based European inception cohort of ulcerative colitis (UC) patients. METHODS: Serum samples from 432 consenting patients were analysed for p-ANCA and ASCA. The results were compared with the cumulative colectomy rate, relapsing disease and total number of relapses. We used multiple regression analyses adjusted for age, sex, residence, disease extent at diagnosis, smoking, familial IBD and drug treatment to study the relationship between serological values and disease course. RESULTS: The relapse rate was higher in the p-ANCA-positive patients: 82% (95% confidence interval [CI] 75-89%) compared with 67% (CI 62-72%, p=0.011) in the p-ANCA-negative patients. The risk of relapsing disease course was higher by a factor of 1.4 (CI 1.1-1.8, p=0.009) for p-ANCA-positive patients than for p-ANCA-negative patients, and the corresponding relative risk (RR) for the total number of relapses was 1.9 (CI 1.7-2.1, p<0.001). In ASCA-positive patients RR for the total number of relapses was 1.8 (CI 1.5-2.1, p<0.001). No significant association with colectomy rate was found for the presence of either p-ANCA or ASCA. CONCLUSION: UC patients positive for p-ANCA and possibly for ASCA may have a more unfavourable long-term disease outcome in terms of relapse than UC patients without these markers.

IBD patients need in health quality of care ECCO consensus.

INTRODUCTION: : Inflammatory bowel diseases (IBD) is a lifelong disorder with increasing incidence and prevalence. IBD primarily affects young people's productivity in addition to direct and indirect costs. The chronic nature of the disease and the patients' requirement of frequent and easy access to the Health Care providers regarding lifelong medication, social and psychological support and regular follow-up in out-patient clinics are important considerations to address. AIM AND METHODS: : To define IBD patient needs in Quality of Health Care (QoHC) in Europe based on up- to date available evidence. The working group consisted of doctors, nurses and patient organizations from 12 European countries and Israel. Pub Med searching was performed as defined in the Delta Method. Each recommendation was graded (RG) in accordance with level of evidence (EL) based on Evidence Based Medicine, Oxford Centre. During UEGW 2007 the group reconvened to agree on the final version for each chapter of guideline statement RESULTS: : Pub Med search led to 6 RCT, 7 reviews, 63 original articles, but no meta-analysis regarding "Information"; "Education"; "Primary Care", "Quality of life", "Psychological help" and "Benchmarking of Health Care systems" in IBD. Seven ECCO statements have been worked out. CONCLUSION: : Evidence-based medicine in QoHC is limited. It is concluded that optimizing QoHC by "information"; "education", "benchmarking" and "psychological analysis" helps the patient to understand the disease and comply with its therapy, increasing QoL, reducing depression and anxiety. Future aspects regarding more evidence-based science and optimization of QoHC in IBD throughout Europe have been proposed.

Pregnancy before and after the diagnosis of inflammatory bowel diseases: retrospective case-control study.

BACKGROUND AND AIM: Inflammatory bowel diseases (IBD) commonly affect women during the reproductive years. The aim of the present study was to evaluate the reproductive histories of patients with ulcerative colitis (UC) and Crohn's disease (CD) considering pregnancies occurring before and after the diagnosis. METHOD: Case-control study evaluating IBD patients, interviewed by questionnaire about outcome of pregnancy and course of disease. RESULTS: A total of 502 pregnancies from 199 patients in the prediagnosis group and 121 pregnancies from 90 patients in the post-diagnosis group were respectively compared with 996 and 204 pregnancies recorded in a control population. In prediagnosis pregnancies, CD was associated with increased risk of preterm delivery (odds ratio [OR] 4.62, 95% confidence interval [CI] 2.77-7.73; P < 0.001 vs controls and OR 3.52, 95% CI 1.75-7.07; P < 0.001 vs UC) and lower birthweight (P < 0.001 vs UC and controls). In post-diagnosis pregnancies, the rate of live births was lower, but not statistically significant in IBD (OR 0.22, 95% CI 0.04-1.25; P = 0.08) and the birthweight was significantly lower in CD than in UC (P < 0.03) and in controls (P < 0.02). In post-diagnosis pregnancies, a higher incidence of congenital abnormalities was found in IBD patients (5.5% vs 0.0%). The spontaneous abortion rate and therapeutic abortions were significantly higher in post than in prediagnosis pregnancies. Neither disease activity at conception nor treatment appeared to influence the outcome of pregnancy. CONCLUSIONS: CD in the preclinical phase has some influence on pregnancy. In patients with IBD our data suggest that conception should not be discouraged. However, because of a modest increase in mild congenital abnormalities and abortions rates, pregnancy in IBD patients should be closely monitored.

Role of ASCA and the NOD2/CARD15 mutation Gly908Arg in predicting increased surgical costs in Crohn's disease patients: a project of the European Collaborative Study Group on Inflammatory Bowel Disease.

BACKGROUND: NOD2/CARD15, the first identified susceptibility gene in Crohn's disease (CD), is associated with ileal stenosis and increased frequency of surgery. Anti-Saccharomyces cerevisiae antibody (ASCA), a serological marker for CD, is associated with ileal location and a high likelihood for surgery. We hypothesized that the presence of ASCA and NOD2/CARD15 mutations could predict increased health care cost in CD. METHODS: CD patients in a prospectively designed community-based multinational European and Israeli cohort (n = 228) followed for mean 8.3 (SD 2.6) years had blood drawn for measurement of ASCA (IgG, IgA), Arg702Trp, Gly908Arg, and Leu1007fsinsC. Days spent in the hospital and the costs of medical and surgical hospitalizations and medications were calculated. RESULTS: The median duration of surgical hospitalizations was longer in Gly908Arg-positive than -negative patients, 3.5 and 1.5 days/patient-year (P < 0.01), and in ASCA-positive than -negative patients, 1.1 and 0 days/patient-year (P < 0.001). Median surgical hospitalization cost was 1,580 euro/patient-year in Gly908Arg-positive versus 0 euro/patient-year in -negative patients (P < 0.01), and 663 euro/patient-year in ASCA-positive versus 0 euro/patient-year in -negative patients (P < 0.001). Differences in cost of medications between groups were not significant. The effect of Gly908Arg was expressed in countries with higher Gly908Arg carriage rates. ASCA raised surgical costs independently of the age at diagnosis of disease. Arg702Trp and Leu1007fsinsC did not affect the cost of health care. CONCLUSIONS: Since CD patients positive for Gly908Arg and ASCA demonstrated higher health care costs, it is possible that measurement of Gly908Arg and ASCA at disease diagnosis can forecast the expensive CD patients.

The prevalence of genetic and serologic markers in an unselected European population-based cohort of IBD patients.

BACKGROUND AND AIM: The aetiology of inflammatory bowel disease (IBD) is unknown, but it has become evident that genetic factors are involved in disease susceptibility. Studies have suggested a north-south gradient in the incidence of IBD, raising the question whether this difference is caused by genetic heterogeneity. We aimed to investigate the prevalence of polymorphisms in CARD15 and TLR4 and occurrence of anti-Saccharomyces cerevisiae (ASCA) and antineutrophil cytoplasmic antibodies (pANCA) in a European population-based IBD cohort. METHODS: Individuals from the incident cohort were genotyped for three mutations in CARD15 and the Asp299gly mutation in TLR4. Levels of ASCA and pANCA were assessed. Disease location and behaviour at time of diagnosis was obtained from patient files. RESULTS: Overall CARD15 mutation rate was 23.9% for CD and 9.6% for UC patients (P < 0.001). Mutations were less present in the Scandinavian countries (12.1%) versus the rest of Europe (32.8%) (P < 0.001). Overall population attributable risk was 11.2%. TLR4 mutation rate was 7.6% in CD, 6.7% in UC patients and 12.3% in healthy controls (HC), highest among South European CD patients and HC. ASCA was seen in 28.5% of CD patients with no north-south difference, and was associated with complicated disease. pANCA was most common in North European UC patients and not associated with disease phenotype. CONCLUSION: The prevalence of mutations in CARD15 varied across Europe, and was not correlated to the incidence of CD. There was no association between mutations in TLR4 and IBD. The prevalence of ASCA was relatively low; however related to severe CD.

Effect of phenotype on health care costs in Crohn's disease: A European study using the Montreal classification.

BACKGROUND: Crohn's disease (CD) is a chronic inflammation of the gastrointestinal tract associated with life-long high health care costs. We aimed to determine the effect of disease phenotype on cost. METHODS: Clinical and economic data of a community-based CD cohort with 10-year follow-up were analyzed retrospectively in relation to Montreal classification phenotypes. RESULTS: In 418 patients, mean total costs of health care for the behavior phenotypes were: nonstricturing-nonpenetrating 1690, stricturing 2081, penetrating 3133 and penetrating-with-perianal-fistula 3356 €/patient-phenotype-year (P<0.001), and mean costs of surgical hospitalization 215, 751, 1293 and 1275 €/patient-phenotype-year respectively (P<0.001). Penetrating-with-perianal-fistula patients incurred significantly greater expenses than penetrating patients for total care, diagnosis and drugs, but not surgical hospitalization. Total costs were similar in the location phenotypes: ileum 1893, colon 1748, ileo-colonic 2010 and upper gastrointestinal tract 1758 €/patient-phenotype-year, but surgical hospitalization costs differed significantly, 558, 209, 492 and 542 €/patient-phenotype-year respectively (P<0.001). By multivariate analysis, the behavior phenotype significantly impacted total, medical and surgical hospitalization costs, whereas the location phenotype affected only surgical costs. Younger age at diagnosis predicted greater surgical expenses. CONCLUSIONS: Behavior is the dominant phenotype driving health care cost. Use of the Montreal classification permits detection of cost differences caused by perianal fistula.

Cost analysis and cost determinants in a European inflammatory bowel disease inception cohort with 10 years of follow-up evaluation.

BACKGROUND & AIMS: Economic analysis in chronic diseases is a prerequisite for planning a proper distribution of health care resources. We aimed to determine the cost of inflammatory bowel disease, a lifetime illness with considerable morbidity. METHODS: We studied 1321 patients from an inception cohort in 8 European countries and Israel over 10 years. Data on consumption of resources were obtained retrospectively. The cost of health care was calculated from the use of resources and their median prices. Data were analyzed using regression models based on the generalized estimating equations approach. RESULTS: The mean annual total expenditure on health care was 1871 Euro/patient-year for inflammatory bowel disease, 1524 Euro/patient-year for ulcerative colitis, and 2548 Euro/patient-year for Crohn's disease (P < .001). The most expensive resources were medical and surgical hospitalizations, together accounting for 63% of the cost in Crohn's disease and 45% in ulcerative colitis. Total and hospitalization costs were much higher in the first year after diagnosis than in subsequent years. Differences in medical and surgical hospitalizations were the primary cause of substantial intercountry variations of cost; the mean cost of health care was 3705 Euro/patient-year in Denmark and 888 Euro/patient-year in Norway. The outlay for mesalamine, a costly medication with extensive use, was greater than for all other drugs combined. Patient age at diagnosis and sex did not affect costs. CONCLUSIONS: In this multinational, population-based, time-dependent characterization of the health care cost of inflammatory bowel disease, increased expenditure was driven largely by country, diagnosis, hospitalization, and follow-up year.

Does pregnancy change the disease course? A study in a European cohort of patients with inflammatory bowel disease.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) often affects patients in their fertile age. The aim of this study was to describe pregnancy outcome in a European cohort of IBD patients. As data are limited regarding the effect of pregnancy on disease course, our second objective was to investigate whether pregnancy influences disease course and phenotype in IBD patients. METHODS: In a European cohort of IBD patients, a 10-yr follow-up was performed by scrutinizing patient files and approaching the patients with a questionnaire. The cohort comprised 1,125 patients, of whom 543 were women. Data from 173 female ulcerative colitis (UC) and 93 Crohn's disease (CD) patients form the basis for the present study. RESULTS: In all, 580 pregnancies, 403 occurring before and 177 after IBD was diagnosed, were reported. The rate of spontaneous abortion increased after IBD was diagnosed (6.5% vs. 13%, p = 0.005), whereas elective abortion was not significantly different. 48.6% of the patients took medication at the time of conception and 46.9% during pregnancy. The use of cesarean section increased after IBD diagnosis (8.1% vs 28.7% of pregnancies). CD patients pregnant during the disease course, did not differ from patients who were not pregnant during the disease course regarding the development of stenosis (37% vs 52% p = 0.13) and resection rates (mean number of resections 0.52 vs 0.66, p = 0.37). The rate of relapse decreased in the years following pregnancy in both UC (0.34 vs 0.18 flares/yr, p = 0.008) and CD patients (0.76 vs 0.12 flares/yr, p = 0.004). CONCLUSIONS: Pregnancy did not influence disease phenotype or surgery rates, but was associated with a reduced number of flares in the following years.

Pegfilgrastim effectively mobilizes PBSC in a poor mobilizer multiple myeloma patient.

Studies performed on mice and healthy human volunteers have shown that a single dose of pegfilgrastim (Peg-GCSF) is effective in stimulating peripheral blood stem cells (PBSC) mobilization. This prompted us to try the stimulation with pegfilgrastim in a patient previously non-mobilizing with a combination of chemotherapy and filgrastim. In December 2003, a 65-yr-old man was diagnosed as having stage III A IgG/k multiple myeloma. He received three courses of polichemotherapy (DC-IE) obtaining a stable response. Afterwards, the patient was treated with high-dose cyclophosphamide (CPM; 7 g/sqm) plus daily 10 mcg/kg filgrastim in order to mobilize PBSC, without success. After 2 months off therapy, the disease progressed and the patient received alternate cycles VAD (vincristine, dexamethasone, adriblastine)/high-dose dexamethasone. A second attempt to mobilize PBSC, using daily 10 mcg/kg filgrastim after the second and third VAD cycle, failed. In a further attempt to mobilize PBSC, we administered a single dose of 12 mg pegfilgrastim on day 5 after a fourth VAD course. Daily evaluation of circulatory CD34+ cells was started from day 8 after the end of chemotherapy. On day +10 postchemotherapy the CD34+ cell count was 24/microL and two aphaeresis were performed, harvesting 1.6 x 10(6) and 0.89 x 10(6) CD34+ cells/kg respectively (total 2.49 x 10(6) cells/kg). The only side effect was moderate skeletal pain. The patient underwent successful transplantation. The median times necessary to recover 0.5 x 10(9) PMN/L and 20 x 10(9) platelets/L after PBSC reinfusion were 9 and 12 d respectively. The patient did not need red blood cell or platelet transfusions. He experienced a sustained engraftment and maintains complete remission 9 months after the reinfusion. In conclusion, a single dose of pegfilgrastim was able to mobilize a sufficient number of CD34+ in a multiple myeloma patient not responsive to two previous attempts with high or standard dose chemotherapy followed by filgrastim. This approach, if confirmed on larger series and other diseases, could open new opportunities in stem cell mobilization for poor or non-mobilizers.

Mini-ICE effectively mobilises peripheral blood stem cells after fludarabine-based regimens in acute myeloid leukaemia.

Fludarabine-based cycles severely impair mobilisation and collection of peripheral blood stem cells (PBSC) in acute myeloid leukaemia (AML). In an effort of reversing this side-effect, we studied the action on mobilisation and collection of PBSC of a low-dose regimen: 5-d Mini-ICE (oral idarubicin and etoposide; subcutaneous cytosine arabinoside) administered after fludarabine-based regimens in seven adult AML patients. Leukapheresis were started when the CD34+ cell count was more than 10/microL. The median number of harvested CD34+ cells was 8.1 x 10(6)/kg (range 3.08-15.2). All the patients were successfully submitted to PBSC transplantation. Median times to neutrophil and platelet recovery were rapid with a normal transfusional support. We suggest that the Mini-ICE programme is feasible, well tolerated and effective in terms of PBSC mobilisation and collection in low-yield AML patients previously treated with fludarabine. It is well known that a negative effect on stem cell mobilisation and harvest is observed not only after fludarabine administration in AML or low-grade lymphomas, but also after cycles based on different agents, such as thalidomide in multiple myeloma. This preliminary experience, if confirmed on larger series and/or other haematological malignancies, could open new opportunities to perform autologous PBSC transplantation in heavily pretreated cases, allowing a full source of therapeutic options before the start of the mobilisation process.

The role of quality of care in health-related quality of life in patients with IBD.

In the literature there are indications of associations between health-related quality of life (HRQoL) in inflammatory bowel disease and disease activity, psychological status, coping, stressful life events, and social support. The aim of this study was to examine whether a relation exists between quality of health care and HRQoL, taking possible confounding variables into account. For this purpose, one single questionnaire was compiled from existing validated questionnaires. A population-based inception cohort of 1056 patients with inflammatory bowel disease in eight countries, diagnosed 6 to 8 years prior to the study, was approached to participate. In total, 824 patients responded (78%), and 517 could be included in statistical analyses. It was shown that in inflammatory bowel disease HRQoL was indeed influenced by quality of care (particularly with regard to the parameters of "providing information," "costs," and "courtesy"), as well as by disease activity, psychological status, type of hospital, social support, stressful life events, and way of administration of the questionnaire. Patients with active disease had lower psychological status and HRQoL scores at the time of the survey than patients without active disease. However, quality of care scores did not differ between these groups. The care aspect "costs" was scored worse by CD compared with UC patients, probably caused by a potentially more expensive treatment. In conclusion, it is shown in a large exploratory study, for the first time, that in inflammatory bowel disease, quality of care has a significant role in determining health-related quality of life.

"Best practice" in inflammatory bowel disease: an international survey and audit.

Background: An observational study was conducted at eight university and four district hospitals in eight countries collaborating in clinical and epidemiological research in inflammatory bowel disease (IBD) to compare European health care facilities and to define current "best practice" with regard to IBD. Methods: The approach used in this multi-national survey was unique. Existing quality norms, developed for total hospital care by a specialized organization, were restricted to IBD-specific care and adapted to the frame of reference of the study group. In each center, these norms were surveyed by means of questionnaires and professional audits in all participating centers. The collected data were reported to the center, compared to data from other hospitals, and used to benchmark. Group consensus was reached with regard to defining current "best practice". Results: The observations in each center involved patient-oriented processes, technical and patient safety, and quality of the medical standard. Several findings could be directly implemented to improve IBD care in another hospital (benchmarks). These included a confidential relationship between health care worker(s) and patients, and availability of patient data. Conclusions: The observed benchmarks, in combination with other subjectively chosen "positive" procedures, have been defined as current "best practice in IBD", representing practical guidelines towards better quality of care in IBD.