The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission.

The cost of caring for patients with inflammatory bowel disease (IBD) continues to increase worldwide. The cause is not only a steady increase in the prevalence of Crohn's disease and ulcerative colitis in both developed and newly industrialised countries, but also the chronic nature of the diseases, the need for long-term, often expensive treatments, the use of more intensive disease monitoring strategies, and the effect of the diseases on economic productivity. This Commission draws together a wide range of expertise to discuss the current costs of IBD care, the drivers of increasing costs, and how to deliver affordable care for IBD in the future. The key conclusions are that (1) increases in health-care costs must be evaluated against improved disease management and reductions in indirect costs, and (2) that overarching systems for data interoperability, registries, and big data approaches must be established for continuous assessment of effectiveness, costs, and the cost-effectiveness of care. International collaborations should be sought out to evaluate novel models of care (eg, value-based health care, including integrated health care, and participatory health-care models), as well as to improve the education and training of clinicians, patients, and policy makers.

Assessment of Disease-related Knowledge Among Children With Inflammatory Bowel Disease and their Family Using IBD-KID2: Evaluating Tool Generalizability.

Children with inflammatory bowel disease (IBD) and their families benefit from improved knowledge of their disease and treatment. Knowledge levels of individual family members are infrequently studied but may identify where education is best directed. We aimed to assess disease-specific knowledge among children with IBD, parents, and siblings, using a validated assessment tool (IBD-KID2), and to establish generalizability of IBD-KID2. Methods: Children with IBD and family members were recruited from tertiary IBD clinics in New Zealand, Australia, and Canada. All participants completed IBD-KID2 online at baseline, and the children with IBD again after 2 weeks to assess reliability. Results: Participants included 130 children with IBD, 118 mothers, 55 fathers, and 37 siblings. Children with IBD had a mean score of 9.1 (SD 2.9) (maximum 15 points), significantly lower than parents (P < 0.005) and higher than siblings (P < 0.005). Scores of children with IBD were positively associated with current age (P < 0.005), age at diagnosis (P = 0.04) and fathers education level (P = 0.02). Significant score correlations were seen between children with IBD and their mother (P < 0.005) but not father. Sibling scores were not correlated with either parent. Test-retest reliability was high. The cohorts from each country were comparable, and no difference in group scores was seen between countries. Conclusion: IBD-KID2 is a generalizable and reliable tool for the assessment of disease and treatment knowledge for children with IBD and their families. Score correlations between parents and children with IBD suggest transfer of knowledge, but sibling knowledge is low and targeted education may be beneficial.

Systematic Review of Self-Management Assessment Tools for Children With Inflammatory Bowel Disease.

The relapsing pattern of illness and diverse management strategies for children with inflammatory bowel disease (IBD) may inhibit their opportunities to develop self-management skills. Interventions focused on the development of these skills require population-specific outcome measures. We provide a comprehensive overview of self-management skills assessment tools that are available for children with IBD that target processes and behaviors outlined as beneficial for the development of these skills. Seven health literature databases were searched using terms related to self-management, transition, IBD, Crohn's disease, ulcerative colitis, and children. Identified studies underwent a process of title and then full text review. Included studies underwent data extraction using a priori quality assessment criteria related to self-management skills, health literacy, suitability for the target population, validity and reliability testing. The searches identified 523 papers, 123 of which underwent full-text review and 10 included in the final analysis. The assessment tools identified showed great diversity in their development approach, content, methodological rigor, and health literacy considerations. The most frequently included self-management skills were related to adherence, communication, attending clinic, and disease/treatment knowledge. None of the tools satisfied the criteria of selection for use in the target population. While many chronic diseases of childhood follow a predictable disease course with established treatment pathways, IBD presents a unique set of challenges. The development of self-management skills is vital for successful disease management, but these skills should be assessed by a tool appropriate for the population and their diverse needs.

Development and Validation of a Self-management Skills Assessment Tool for Children With Inflammatory Bowel Disease: The Inflammatory Bowel Disease-Skills Tasks and Abilities Record (IBD-STAR).

OBJECTIVES: For children with inflammatory bowel disease (IBD), the development of self-management skills has the potential to improve disease outcomes. No assessment tools are aimed at measuring self-management skills in this population. A tool was developed called the IBD-Skills Tasks and Abilities Record (IBD-STAR) which measures children's allocation of responsibility for specific skills. IBD-STAR contains 18 items, scored whether completed independently (score 2), with help (score 1) or not at all (score 0). METHODS: Children with IBD completed IBD-STAR; one parent and a gastroenterologist completed a series of visual analogue scales that corresponded with each IBD-STAR section. Children's IBD-STAR scores were examined against independent variables and compared with the parent and clinician visual analogue scale scores. Reliability was calculated using Cronbach's alpha. RESULTS: Twenty-five Cronbach's alpha with IBD participated, mean age 14 years (standard deviation (SD) 1.7), 14 (56%) were boys, and 21 (84%) had Crohn's disease. The mean IBD-STAR score was 27.1 (SD 5.7), equivalent to a score of 75%. Age was the only independent variable significantly associated with scores (P = 0.017). Parents consistently underestimated their children in all sections, but clinician assessments were more closely aligned. Reliability for IBD-STAR was good with an overall Cronbach's alpha of 0.84. CONCLUSION: IBD-STAR reports the allocation of responsibility for self-management skills with good agreement between children and clinician, and with comprehensible differences with their parents. Such a tool may be used to identify children with IBD in need of support or to measure the efficacy of targeted interventions.

Assessment of Knowledge Levels Following an Education Program for Parents of Children With Inflammatory Bowel Disease.

Children with inflammatory bowel disease (IBD) and their parents have increasing roles in disease management and require sufficient, appropriate information for communication with their clinical team. Formal education is effective at improving disease knowledge, disease outcomes, and mental health, yet few interventions have been targeted for parents of children with IBD. A two day parent education program was held at the annual residential camp for children with IBD in New Zealand with knowledge levels tested pre and post intervention using a validated assessment tool: IBD-KID2. Thirty parents consented, 25 completed the study, 70% were female and 83% had a child with Crohn's disease. The pre-intervention mean score (maximum fifteen) was 10.6 (SD 2.9), with no associations with independent variables. Knowledge levels increased significantly following the education program to a mean 12.6 (SD 2.0) (p < 0.005). Disease specific knowledge may improve outcomes and should, therefore, be reinforced during clinic encounters, and regarded as an ongoing endeavor.

Validation of a Revised Knowledge Assessment Tool for Children with Inflammatory Bowel Disease (IBD-KID2).

INTRODUCTION: For children with inflammatory bowel disease (IBD), acquired knowledge of their condition and treatment is integral to their adherence and self-management. Assessing their knowledge is vital to identify deficits that may affect disease management. IBD-KID2 is a knowledge assessment tool written for children aged 8 years and over with IBD. OBJECTIVES: In order to examine validity and reliability, a study was carried out using IBD-KID2 in a paediatric IBD population and a number of comparator groups with established levels of IBD knowledge. METHODS: IBD-KID2 was administered to 4 participant groups in Christchurch Hospital, New Zealand: children with IBD (n = 22), children without IBD (n = 20), medical staff (n = 15), and administration staff (n = 15). Between-group differences were tested using ANOVA and pairwise comparisons made with the IBD group. Repeat assessments by the IBD group determined test-retest reliability (n = 21). RESULTS: The mean age (range) of the paediatric groups were: IBD 13.3 years (8-18), without IBD 11.9 years (8-15). Group mean scores (SD) were: IBD 8.5 (±2.3), without IBD 3.7 (±2.2), medical staff 13.5 (±1.3), administration staff 6.3 (±2.5). Group means were all significantly different to the IBD group. Test-retest mean at baseline (8.4, CI ±2.4) and repeat (9.0, CI ±2.4) were not significant. Intraclass correlation coefficient was 0.82. Internal reliability was 0.85, and item-total statistics showed no improvement by specific item removal. CONCLUSIONS: IBD-KID2 could distinguish between groups with different knowledge levels. Repeat assessment shows comparable scores on retest and good reproducibility. IBD-KID2 is a valid and reliable tool for use in the paediatric IBD population.

Response pattern analysis of IBD-KID: A knowledge assessment tool for children with inflammatory bowel disease.

AIM: Paediatric inflammatory bowel disease (IBD) is a chronic relapsing condition requiring adherence to complex treatment regimens to achieve best outcomes. Adherence is frequently low in this population but can be improved by increasing disease- and treatment-related knowledge. The IBD-knowledge inventory device (IBD-KID) is a knowledge assessment tool specifically developed and validated for children with IBD. To analyse IBD-KID participant response patterns in order to review the strength of the tool. METHODS: A cohort of children with IBD completed IBD-KID, and their responses were used to assess the tool's validity and feasibility. Item response analysis assessed the item difficulty and the ability of items to discriminate between high/low scorers. The analysis considered item structure, readability and the effectiveness of multiple choice items. RESULTS: A total of 105 completed IBD-KID assessments showed that 12 items (52%) had an acceptable difficulty level, and 17 (74%) were effective at discriminating between high/low scorers. Nine (61%) had good readability, but comprehension levels ranged from 5 to 18 years. Seven (30%) had elevated 'don't know' responses, highlighting the need for content and construction review. Of the 10 multiple choice items, 9 were complex and not functioning efficiently. Internal consistency was acceptable but could be improved by removing two items. CONCLUSIONS: The response analysis metrics were reviewed by an expert panel and provided a framework for IBD-KID improvements with the aim of increasing discrimination and reducing difficulty without adversely affecting reliability. The proposed revisions will address components that may have caused children to answer incorrectly due to confusion rather than lack of knowledge.

Asia-Pacific consensus statements on Crohn's disease. Part 2: Management.

The Asia Pacific Working Group on Inflammatory Bowel Disease was established in Cebu, Philippines, at the Asia Pacific Digestive Week conference in 2006 under the auspices of the Asian Pacific Association of Gastroenterology (APAGE) with the goal of developing best management practices, coordinating research and raising awareness of IBD in the region. The consensus group previously published recommendations for the diagnosis and management of ulcerative colitis (UC) with specific relevance to the Asia-Pacific region. The present consensus statements were developed following a similar process to address the epidemiology, diagnosis and management of Crohn's disease (CD). The goals of these statements are to pool the pertinent literature specifically highlighting relevant data and conditions in the Asia-Pacific region relating to the economy, health systems, background infectious diseases, differential diagnoses and treatment availability. It does not intend to be all-comprehensive and future revisions are likely to be required in this ever-changing field.

Disease activity assessment in IBD: clinical indices and biomarkers fail to predict endoscopic remission.

BACKGROUND: In the current management paradigm, mucosal healing is preferred over clinical remission as a therapeutic end point in inflammatory bowel disease (IBD) because of the benefits engendered with respect to durability of remission. Colonoscopy, however, is not suitable for regular disease monitoring, and routine clinical assessment is often inaccurate with respect to endoscopic disease activity. The current investigation set out to characterize the relationship that exists between endoscopically determined IBD activity and clinical and biochemical measures of disease severity and to determine clinically useful thresholds for use in clinical practice. METHODS: Patients attending for colonoscopy with known or suspected IBD were recruited. Clinical disease activity was recorded as per the Harvey-Bradshaw Index for Crohn's disease or the simple clinical colitis activity index for ulcerative colitis. Endoscopic activity was recorded using the simple endoscopic score for Crohn's disease or the modified Baron score for ulcerative colitis. Receiver operating characteristic analysis determined the predictive value and optimal predictive thresholds for clinical and biomarker data. RESULTS: The Harvey-Bradshaw Index was not able to distinguish active from inactive Crohn's disease. The sensitivity, specificity, and positive and negative predictive values of simple clinical colitis activity index to detect endoscopic active disease were 43%, 96%, 94%, and 51%, respectively. Any elevation of C-reactive protein or fecal calprotectin was predictive of active mucosal disease, however, no lower threshold could be identified that predicted disease in remission. CONCLUSIONS: C-reactive protein and fecal calprotectin are useful for the identification of endoscopically active IBD, but normal results do not confirm endoscopic remission.

Home food availability is associated with multiple socio-economic indicators in 50 year olds from Canterbury, New Zealand.

Financial restraints and poverty lead to poor diets and poor health outcomes. Limited research shows that socioeconomic status is related to home availability of certain foods. However, studies in this area have used different socio-economic indicators, which may not equally influence eating-related behaviors. Using multiple indicators of socio-economic status may provide a more accurate picture of these relationships. The aim of this study was to investigate whether several socio-economic indicators are independently associated with home availability of selected foods known to influence chronic disease risk in 50 year olds from Canterbury, New Zealand, participating in the CHALICE study. Participants were selected randomly from health research extracts from Canterbury. Data from 216 participants (110 females, 106 males) were included. The presence (but not quantity) of foods/beverages in the home was measured by a validated home food inventory. Linear regression analyses were performed for the following home food inventory scores: fruit, vegetables, lower fat dairy, obesogenic foods and sweetened beverages with household income, standard of living and education using multivariate models. Higher household income and standard of living were individually associated with a 2% to 3% higher fruit and vegetables (3 to 5 types/forms) and total food scores (6 to 9 types/forms) (p<0.03). Higher education level was associated with a 2.5% increase in fruit and vegetables score (4 types/forms) and an 8% decrease in sweetened beverages score (0.4 beverages) (p<0.02). These results suggest that using only one measure of socio-economic status cannot accurately capture the effects of social inequalities in food availability. Those experiencing the most social disadvantage had a lesser availability of fruit and vegetables which may be detrimental to good health.

Dietary intake in midlife and associations with standard of living, education and nutrition literacy.

AIM: Cardiovascular disease is a leading cause of death in New Zealand, but risk factors may be decreased by consuming a heart healthy diet. This pilot study investigated whether participants met the guidelines for a heart healthy diet and whether a novel heart healthy dietary pattern could be identified using principal components analysis (PCA). The second aim of this project was to assess if higher education, standard of living and nutrition literacy are associated with a heart healthy dietary pattern. METHOD: This exploratory study was undertaken using data from the first participants enrolled in the Canterbury Health Ageing and Lifecourse study: an observational study of 50 year olds in the Canterbury District Health Board region. Eighty-two people were selected from the General and Maori electoral role and interviewed prior to the 22 February 2011 Christchurch Earthquake. PCA was conducted to identify dietary patterns, based on intake of specific nutrients as indicated by the New Zealand and international heart healthy dietary guidelines. RESULTS: 62 participants completed questionnaires and an estimated food record. No participants met all five of the heart healthy dietary guidelines. One dietary pattern was produced by PCA: a "higher CVD risk" pattern. Regression analysis indicated that higher standard of living, education and nutrition literacy were inversely associated with a "higher CVD risk" pattern. CONCLUSION: Higher standard of living, education and nutrition literacy were associated with a healthier dietary eating pattern. However, as no participants met all the dietary recommendations more education and support is needed to help people meet these.

Psychotherapy for inflammatory bowel disease: a review and update.

BACKGROUND: Psychotherapy may be a useful intervention for inflammatory bowel disease (IBD) patients. We systematically reviewed all randomized controlled trials that have been performed in psychotherapy for inflammatory bowel disease patients. METHODS: Systematic searches were undertaken on 1 and 8 March, 2012 of studies of psychotherapy for IBD. RESULTS: Eighteen studies (19 papers) were included in this review. Psychotherapy was found to have minimal effect on measures of anxiety, depression, QOL and disease progression although shows promise in reducing pain, fatigue, relapse rate and hospitalisation, and improving medication adherence. It may also be cost effective. CONCLUSIONS: The effects of psychotherapy on IBD is mixed: future studies should determine whether patient screening or measuring different dependent variables improves outcomes and whether particular psychotherapies are superior over others.

The cost of paediatric and perianal Crohn's disease in Canterbury, New Zealand.

AIMS: The aim of this study was to determine the direct and indirect costs of Crohn's disease (CD) in paediatric and perianal patients in Canterbury in one year. METHODS: A retrospective cross-sectional analysis was performed. Paediatric CD patients and adult patients with perianal CD were recruited over a three month period. Interviews were conducted to obtain information regarding demographic, socioeconomic factors, and indirect costs. Hospital clinical notes were reviewed to determine direct health care utilisation and costs. RESULTS: Forty-nine patients (24 paediatric and 25 perianal CD) were enrolled. In one year the total costs per patient for paediatric CD were $14,375 with direct and indirect costs comprising $12,583 and $1,792, respectively. The total costs per patient for perianal CD were $20,366 with direct and indirect costs comprising $18,261 and $2,105, respectively. Extrapolating these data across New Zealand, the total cost of paediatric and perianal CD in one year is approximately $25.9 million and $36.7 million, respectively. CONCLUSIONS: Paediatric and perianal CD are high-cost diseases with significant costs borne by patients and their families. Expensive pharmaceuticals comprise a significant proportion of the costs: increased access to these drugs might decrease hospital admissions and prevent work absenteeism and loss of carer productivity.

Association of FcgR2a, but not FcgR3a, with inflammatory bowel diseases across three Caucasian populations.

BACKGROUND: The Fc receptors II and III (FcgR2a, and FcgR3a) play a crucial role in the regulation of the immune response. The FcgR2a*519GG and FcgR3a*559CC genotypes have been associated with several autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, nephritis, and possibly to type I diabetes, and celiac disease. In a large multicenter, two-stage study of 6570 people, we tested whether the FcgR2a and FcgR3a genes were also involved in inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC). METHODS: We genotyped the FcgR2a*A519G and FcgR3a*A559C functional variants in 4205 IBD patients in six well-phenotyped Caucasian IBD cohorts and 2365 ethnically matched controls recruited from the Netherlands, Spain, and New Zealand. RESULTS: In the initial Dutch study we found a significant association of FcgR2a genotypes with IBD (P-genotype = 0.02); while the FcgR2a*519GG was more common in controls (23%) than in IBD patients (18%; odds ratio [OR] = 0.75; 95% confidence interval [CI] 0.61-0.92; P = 0.004). This association was corroborated by a combined analysis across all the study populations (Mantel-Haenszel [MH] OR = 0.84; 0.74-0.95; P = 0.005) in the next stage. The Fcgr2a*GG genotype was associated with both UC (MH-OR = 0.84; 0.72-0.97; P = 0.01) and CD (MH-OR = 0.84; 0.73-0.97; P = 0.01), suggesting that this genotype confers a protective effect against IBD. There was no association of FcgR3a*A559C genotypes with IBD, CD, or UC in any of the three studied populations. CONCLUSIONS: The FcgR2a*519G functional variant was associated with IBD and reduced susceptibility to UC and to CD in Caucasians. There was no association between FcgR3a*5A559C and IBD, CD or UC.

Pharmacoeconomic analyses of azathioprine, methotrexate and prospective pharmacogenetic testing for the management of inflammatory bowel disease.

OBJECTIVES: To compare the cost effectiveness of azathioprine (AZA), methotrexate (MTX) and no immunosuppression for maintaining remission of moderate to severe inflammatory bowel disease (IBD) in New Zealand Caucasians, and to determine whether prospective testing for poor metabolisers of AZA by genotype or phenotype is cost effective. METHODS: Pharmacoeconomic models were developed to compare treatment costs and effects (QALYs) in theoretical populations of 1,000 IBD patients over a 1-year period. Efficacy and tolerability profiles for AZA and MTX were taken from the literature. The costs (year 2004 values) of the drugs and treatment of adverse effects were estimated from New Zealand drug and service costs. Representations of the patients' health-related quality of life (HR-QOL) were obtained from clinicians via the EQ-5D health state classification system and valued using the New Zealand EQ-5D social tariff. The effects of genotyping or phenotyping a population for thiopurine methyltransferase (TPMT) status were compared using the prevalence of TPMT deficiency in Caucasians, the relative risks of neutropenia and the associated costs. RESULTS: Net cost savings (vs no immunosuppressant treatment) of approximately 2.5 million and 1 million New Zealand dollars were realised for AZA and MTX, respectively, for the theoretical 1,000 patients, and AZA generated 877 QALYs compared with 633 for MTX. Phenotype and genotype testing generated net cost savings (vs no testing) of 120,000 and 11,000 New Zealand dollars, respectively. Savings related to phenotype tests were greater because of the lower assay costs of phenotype testing and a greater likelihood of pre-empting neutropenia. CONCLUSION: Our model suggests that both MTX and AZA may generate significant net cost savings and benefits for patients with IBD in New Zealand, with AZA likely to be more cost effective than MTX. Prospective testing for poor metabolisers of AZA may also be cost effective, with phenotype testing likely to be more cost effective than genotype testing.