Abstract Background Engagement with research has been shown to be associated with improved patient experience and outcomes at an institutional level in several disease areas1-3. However, this relationship has so far not been explored in inflammatory bowel disease (IBD). The aim of the present study was to assess the relationship between research activity of IBD services across the United Kingdom (UK) and patient-reported quality of care provided by that service. Methods Patient-reported care quality data was collected across the UK through the 2023 IBD UK Patient Survey. Patients rated the overall quality of their care in the preceding 12 months as “poor”, “fair”, “good”, “very good” or “excellent”. High-quality care was defined as responses of “excellent,” “very good,” or “good”. Data related to paediatric services and adult services with fewer than 5 patient responses were excluded. The proportion of patients reporting high quality care at each service was compared with the number of patients recruited to research studies registered with the national central portfolio management system (CPMS) within the previous three years (2020-2022). The CPMS is a cloud-based system that holds the National Institute for Health and Care Research (NIHR) clinical research network portfolio of studies in England, in addition to the network of portfolios in Northern Ireland, Scotland and Wales. Analyses were performed where recruitment identified IBD as the primary subspecialty and gastroenterology was the managing specialty. Results Research recruitment data from 32,432 recruited research participants across 192 IBD services were aligned with 11,738 care quality responses and included in the analysis. Overall, there was a positive correlation between the number of patients recruited to research studies in an IBD service and the proportion of patients reporting high quality care (Spearman r (95% CI) 0.2044 (0.06047-0.3400) p=0.0045). An iterative Grubbs’ Test identified 6 IBD services as outliers. After excluding these services, the positive correlation was maintained (Spearman r (95% CI) 0.1946 (0.04788-0.3331) p=0.0078; Figure 1). Conclusion This study identifies a positive association between the research activity of IBD services and patient-perceived quality of care, highlighting the benefits of active research engagement in IBD care. Acknowledgements We are grateful to the patients who submitted survey responses and to the IBD UK Board members. References 1.Downing A, Morris EJ, Corrigan N, et al. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut. 2017;66(1):89-96. doi:10.1136/gutjnl-2015-311308 2.Ozdemir BA, Karthikesalingam A, Sinha S, et al. Research activity and the association with mortality. PLoS One. 2015;10(2):e0118253. Published 2015 Feb 26. doi:10.1371/journal.pone.0118253 3.Jonker L, Fisher SJ, Dagnan D. Patients admitted to more research-active hospitals have more confidence in staff and are better informed about their condition and medication: Results from a retrospective cross-sectional study. J Eval Clin Pract. 2020;26(1):203-208. doi:10.1111/jep.13118
Abstract Background Infliximab has transformed the management of Inflammatory Bowel Disease (IBD) however it has a significant cost burden. Additionally, demand on our IBD day case infusion unit has tripled in the last 7 years leading to long delays in treatment initiation. Switching patients from intravenous (IV) to subcutaneous (SC) infliximab reduces the demand on infusion units and offers patients more flexibility. We aim to compare the real-life direct (drug price and administration costs) and indirect costs (travel costs and time lost to work for patients) associated with switching patients from IV to SC CT-P13, an infliximab biosimilar, in a tertiary UK IBD centre. Methods We analysed data from all adult IBD patients at Leeds Teaching Hospitals Trust who had been identified as eligible to switch from IV to SC CT-P13. All patients were on a standard dosing regimen (5mg/kg 8 weekly) and were invited to switch via a letter from the IBD lead clinician. Patients were classified as IV or SC based on their decision to switch within 3 months. Figure one demonstrates how direct and indirect costs were calculated. We then compared the calculated annual costs by intention-to-treat (i.e. if all patients had switched from IV to SC) and as-treated (comparing all on IV pre-switch to some on IV and some SC post switch). Results 169 patients were identified as eligible to switch to SC CT-P13, 98 (58%) switched within 3 months. One patient was excluded as they had subsequently moved out of area. Prior to switching, total annual IV cost for 168 patients was calculated as £689,507.04 (direct = £653,671.20, indirect = £35,835.84). In the as-treated analysis after the switch, IV cost for 70 patients was £285,490.02 (direct = £272,363, indirect = £13,127.02) and SC cost for 98 patients was £389,432.81 (direct = £382,200, indirect = £7,232.81) giving a total annual cost for 168 patients of £674,922.83. In this analysis, after a proportion of patients switched to SC CT-P13, annual direct costs to the health service were £891.80 more per year, however indirect costs or cost to the patient were lower resulting in a lower total spend. See figure 2 for a breakdown of direct and indirect costs. Conclusion Our real-world analysis demonstrates that a switch from IV to SC CT-P13 is broadly cost neutral to the health service. Whilst the SC option has higher drug costs, a switch to SC allows for more efficient running of IV induction therapies by reducing demand on the infusion unit and reduces costs to the patient in terms of travel, parking and potential loss of working hours.
Abstract Background Lower serum free triiodothyronine-to-thyroxine (fT3/fT4) ratio has been linked to non-response to treatment in a range of diseases, including in biologic-treated patients with IBD. We sought to assess whether baseline serum fT3/fT4 ratio predicted primary non-response (PNR) and non-remission to infliximab and adalimumab in patients with Crohn’s disease. Methods We included 997 adult participants from the Personalised Anti-TNF Therapy in Crohn’s Disease study (PANTS). Thyroid function tests, using the Roche Elecsys TSH immunoassay and T3 and T4 electrochemiluminescence assays, were measured on stored baseline samples (prior to biologic treatment). PNR, assessed at week 14, was defined as treatment failure (including IBD-related surgery), ongoing corticosteroid use, or both CRP failing to fall to ≤3 mg/L, or by 50% from baseline, and HBI failing to fall to ≤4, or by 3 points. Non-remission, assessed at week 54, was defined as either CRP of > 3mg/L or HBI of >4 points, ongoing corticosteroid therapy, or exit for treatment failure. Results Serum fT3, fT4 and TSH concentrations were similar in infliximab (n=549) and adalimumab treated (n=448) patients. Baseline median [IQR] fT3/fT4 ratios were lower in women than men (0.30 [0.27 - 0.34] vs 0.32 [0.28 - 0.36], p<0.001), in patients with more severe inflammatory disease, and in patients receiving corticosteroids (0.28 [0.25 - 0.33] vs 0.32 [0.29 - 0.36], p<0.001). Multivariable logistic regression analysis demonstrated that fT3/fT4 ratio was independently associated with PNR at week 14 (OR 0.51, 95% CI 0.31 – 0.85, p = 0.009), however when stratified by drug and adjusted for variables known to be associated with PNR, low fT3/fT4 ratio remained associated with PNR for adalimumab, but not infliximab. After excluding patients treated with corticosteroids at baseline, there was no difference in fT3/fT4 ratio in those who experienced PNR compared to those who did not (PNR: [128/630] 0.31 [0.28 – 0.35] vs no PNR: [502/630] 0.32 [0.29 – 0.36], p = 0.095). The optimal threshold to determine PNR was 0.31 (AUC 0.57 [95% CI 0.54 - 0.61] sensitivity 0.62 [95% CI 0.41 - 0.74], specificity 0.53 [95% CI 0.42 - 0.73]). No association was seen for baseline fT3/fT4 ratio and non-remission or changes in faecal calprotectin concentrations at week 54. Conclusion Lower baseline serum fT3/fT4 ratio was independently associated with female sex, higher inflammatory burden at baseline, and baseline corticosteroid use, and predicted PNR to anti-TNF therapy at week 14, but not non-remission or change in faecal calprotectin concentrations at week 54. Overall, however, the diagnostic accuracy of baseline fT3/fT4 ratio to predict PNR to anti-TNF treatment was modest, limiting its clinical utility.
Abstract Background Budesonide MMX (Cortiment) is superior to placebo for mild to moderate UC flares and has a favourable side effect profile. However, no head-to-head data with Prednisolone exist. During the COVID-19 pandemic many IBD units chose Cortiment as first line treatment for outpatients’ flares of UC. The aim of this retrospective study was to compare outcomes of Cortiment vs Prednisolone treatment for UC. Methods Hospital based prescriptions from of 3 UK IBD units were extracted from computerized pharmacy records for the time periods between 1/3/2019 – 30/6/2019 and 1/3/2020 – 30/6/2020. All adult outpatients treated with oral steroids for a flare of UC were included. Baseline data included age, sex, phenotype, IBD medications, symptoms and changes to medication at time of steroid prescription. Follow up data included need for hospital admission for acute severe ulcerative colitis, symptoms at 4 weeks and end of treatment, need for rescue Prednisolone (Cortiment group only). Primary outcome was symptomatic improvement at 4 weeks. Results The 2019 (94 patients) and 2020 (127 patients) cohorts did not differ significantly with regards to age, sex, phenotype and baseline characteristics. The proportion of Cortiment prescriptions rose significantly from 24.5% in 2019 to 70.1% in 2020 (p<0.001). At week 4 of treatment there were statistically significant differences in mean bowel frequency (3.49 in 2019 vs 5.85 in 2020, p=0.001), rectal bleeding <50% (89.7% of patients in 2019 vs 73.1% in 2020, p=0.039) and physician global assessment (39.2% of patients in remission in 2019 compared to 19.8% in 2020, p=0.045).There was no significant difference in hospital admissions, rectal bleeding and physician global assessment at end of treatment. Patients prescribed Cortiment in 2019 had similar baseline characteristics to those prescribed Cortiment in 2020. Mean bowel frequency at four weeks was significantly higher in 2020 (6.18) compared to 2019 (3.69, p=0.034), but rectal bleeding (p=0.388) and physician global assessment at week four did not differ between 2019 and 2020 (p=0.422). Rescue Prednisolone was required in 10% of Cortiment patients in 2019 vs 31.3% in 2020 (p=0.058). Conclusion Cortiment was used as the main first line steroid for UC during the pandemic to reduce the risk of adverse COVID-19 outcomes. This change in treatment was, however, associated with worse UC outcomes at 4 weeks and 31% needed rescue Prednisolone. As active IBD is associated with worse COVID-19 outcomes clinicians should carefully evaluate the choice of steroid to achieve optimal disease control and COVID-19 risk minimization.
Abstract Background The IBD Benchmarking Tool, comprising an online Service Self-Assessment and Patient Survey, has provided a unique and comprehensive picture of Inflammatory Bowel Disease (IBD) care across the UK. The aim was to evaluate current local service performance to facilitate future quality improvement. Methods The IBD Patient Survey (PS) ran from July to November 2019 and the Service Self-Assessment (SSA) from October 2019 to January 2020. Detailed views were collected of the quality of IBD care from patient and clinician perspectives, measured against the UK IBD Standards 2019.1 The IBD UK National Report will be published in April 2021. Results 10,222 patients completed the PS. 89% (9,100/10,222) had found it hard to cope with having Crohn’s or Colitis over the previous year. 72% (6,954/9,640) rated the quality of their care as excellent, very good or good and 28% (2,686/9,640) rated the quality of their care as fair or poor. The top three factors that predicted how highly people with IBD rated their quality of care were: feeling supported by a team of specialists; having regular reviews; and discussing wider life goals and priorities, as part of planning their care. 26% (535/2,089) had waited more than a year for their diagnosis. 41% (849/2,087) had visited Accident & Emergency at least once before being diagnosed. 32% (656/2,057) were not offered any information about their condition when diagnosed. 91% (8,284/9,099) did not have a personalised care plan. Over the previous 12 months, 70% (6,732/9,574) had one or more flares and 72% (1,622/2,250) of inpatient admissions were unplanned. A key finding from the SSA (166 centres: 134 adult, 32 paediatric) was that no adult IBD services reported meeting the IBD Standards’ recommendation for whole time equivalent (WTE) staffing across the IBD team. Where services reported meeting the WTE for IBD nurse specialists, patients were more likely to rate the quality of their care highly and to have regular clinical review of their Crohn’s or Colitis. Conclusion The results highlight four key areas for change: improvements in diagnosis and information provision; personalised care and support for self-management; faster access to specialist advice and treatment; and effective multidisciplinary team (MDT) working. The Report sets out recommendations for action in each of these areas. To our knowledge, this is the first time that healthcare professionals and patients have assessed care against a common set of standards. The IBD Benchmarking Tool provides location-matched service performance and patient experience as an exemplar for others to follow. Reference
BACKGROUND:Corticosteroids are central to inducing remission in inflammatory bowel disease (IBD) but are ineffective maintenance agents.AIM:To benchmark steroid usage in British outpatients and assess factors associated with excess exposure.METHODS:We recorded steroid use in unselected IBD outpatients. Cases meeting criteria for steroid dependency or excess were blind peer reviewed to determine whether steroid prescriptions were avoidable. Associations between steroid use and patient/institutional factors were analysed.RESULTS:Of 1176 patients, 30% received steroids in the prior 12 months. 14.9% had steroid dependency or excess, which was more common in moderate/severe ulcerative colitis (UC) than Crohn's disease (CD) (42.6% vs 28.1%; P = .027). Steroid dependency or excess was deemed avoidable in 49.1%. The annual incidence of inappropriate steroid excess was 7.1%. Mixed-effects logistic regression analysis revealed independent predictors of inappropriate steroid excess. The odds ratio (OR, 95%CI) for moderate/severe compared to mild/quiescent disease activity was 4.59 (1.53-20.64) for UC and 4.60 (2.21-12.00) for CD. In CD, lower rates of inappropriate steroid excess were found in centres with an IBD multi-disciplinary team (OR 0.62 [0.46-0.91]), whilst dedicated IBD clinics protected against inappropriate steroid excess in UC (OR 0.64, 95% CI 0.21-0.94). The total number of GI trainees was associated with rates of inappropriate steroid excess.CONCLUSIONS:Steroid dependency or excess occurred in 14.9% of British IBD patients (in 7.1% potentially avoidable). We demonstrated positive effects of service configurations (IBD multi-disciplinary team, dedicated IBD clinics). Routine recording of steroid dependency or excess is feasible and should be considered a quality metric.
Journal of Gastroenterology and HepatologyVolume 32, Issue 11 p. 1793-1793 Education and Imaging Gastrointestinal: Cause or effect: A case of microcytic anemia I Carbery, I Carbery Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UKSearch for more papers by this authorO Rotimi, O Rotimi Department of Histopathology, Leeds Teaching Hospitals NHS Trust, Leeds, UKSearch for more papers by this authorCP Selinger, CP Selinger Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UKSearch for more papers by this author I Carbery, I Carbery Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UKSearch for more papers by this authorO Rotimi, O Rotimi Department of Histopathology, Leeds Teaching Hospitals NHS Trust, Leeds, UKSearch for more papers by this authorCP Selinger, CP Selinger Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UKSearch for more papers by this author First published: 10 October 2017 https://doi.org/10.1111/jgh.13718Citations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume32, Issue11November 2017Pages 1793-1793 RelatedInformation
Introduction Vedolizumab (VDZ) is an α4β7 anti-integrin licensed to treat UC and CD. We aimed to assess clinical outcomes and safety of VDZ in IBD patients treated in several hospitals across northern England. Method We retrospectively collected data of patients treated with VDZ at 8 UK centres since 2014. We evaluated clinical response at 12 and 52 weeks using the Physician Global Assessment (PGA), Harvey-Bradshaw Index (HBI) or Mayo score. We collected C reactive protein (CRP) and faecal calprotectin (FC) at baseline and follow-up. Fisher exact test and student’s t-test were used to determine statistical significance. Results Of 183 patients (mean 41 years, F/M ratio 1.4:1) 120 (65.6%) had CD, 61 (33.3%) UC, and 2 (1.1%) IBD-U. 18 patients were active smokers. 57 (31%) received immunomodulators, 68 (37%) steroid bridging therapy and 27 (15%) patients were anti-TNF naïve. PGA remission was observed in 33 (31%) CD, 26 (44.8%) UC and 2 (100%) IBD-U patients at 12 weeks and in 6/48 (12.5%) CD and 16/36 (44.4%) UC patients at 52 weeks. A partial response was observed in 51 (48%) CD and 25 (43.1%) UC patients at 12 weeks and in 8/48 (16.6%) CD and 10/36 (27.7%) UC patients at 52 weeks. At 52 weeks, VDZ was more effective in maintaining remission in UC than CD (p<0.05). In CD patients, mean CRP, FC and HBI significantly improved at 12 weeks, with a further improvement of HBI at 52 weeks. In UC, mean FC and Mayo score significantly decreased at 12 weeks, whereas CRP did not improve. Non-smoking status was associated with better response (p<0.05). 43 patients (23.5%) discontinued VDZ (average exposure 4.5 months). Reported side effects occurred in 21 cases (11%): 3 urticarial rashes, 6 pneumonias, 3 nasopharyngitis, 2 skin infections, 2 sepsis, 1 viral meningitis, 1 EBV infection, 1 urinary tract infection, and 2 abnormal liver function tests. Overall incidence of infection was 12 per 100 person-years of VDZ exposure. Conclusion VDZ is a safe and effective therapy even in this cohort of predominantly anti-TNF exposed patients. Induction data are similar for CD and UC, but VDZ seems to be more successful in maintaining remission for UC. The incidence of infectious complications was comparable to that seen with anti-TNF therapies (average 14 per 100 person-years). Disclosure of Interest M. Lenti: None Declared, S. Levison: None Declared, E. Eliadou: None Declared, R. Robert Willert: None Declared, K. Kemp: None Declared, C. Stansfield: None Declared, A. Assadsangabi: None Declared, S. Singh: None Declared, B. Crooks: None Declared, S. Tattersall: None Declared, C. Kenneth: None Declared, S. Subramanian: None Declared, C. Probert: None Declared, D. Storey: None Declared, B. Gregg: None Declared, P. Smith: None Declared, E. Liu: None Declared, J. Limdi: None Declared, A. Johnston: None Declared, PJ Hamlin: None Declared, C. Selinger Conflict with: Warner Chilcott, and Abbvie, Conflict with: Warner Chilcott, Dr Falk, Abbvie, Janssen and Takeda
Patient education forms a cornerstone of management of inflammatory bowel disease (IBD). The Internet has opened new avenues for information gathering.
BACKGROUND:Smoking demonstrates divergent effects in Crohn's disease (CD) and ulcerative colitis (UC). Smoking frequency is greater in CD and deleterious to its disease course. Conversely, UC is primarily a disease of nonsmokers and ex-smokers, with reports of disease amelioration in active smoking.AIM:To determine the prevalence of smoking and its effects on disease progression and surgery in a well-characterised cohort of inflammatory bowel diseases (IBD) patients.METHODS:Patients with smoking data of the Sydney IBD Cohort were included. Demographic, phenotypic, medical, surgical and hospitalisation data were analysed and reported on the basis of patient smoking status.RESULTS:1203 IBD patients were identified comprising 626 CD and 557 UC with 6725 and 6672 patient-years of follow-up, respectively. CD patients were more likely to smoke than UC patients (19.2% vs. 10.2%, P < 0.001). A history of smoking in CD was associated with an increased proportional surgery rate (45.8% vs. 37.8%, P = 0.045), requirement for IBD-related hospitalisation (P = 0.009) and incidence of peripheral arthritis (29.8% vs. 22.0%, P = 0.027). Current smokers with UC demonstrated reduced corticosteroid utilisation (24.1% vs. 37.5%, P = 0.045), yet no reduction in the rates of colectomy (3.4% vs. 6.6%, P = 0.34) or hospital admission (P = 0.25) relative to nonsmokers. Ex-smokers with UC required proportionately greater immunosuppressive (36.2% vs. 26.3%, P = 0.041) and corticosteroid (43.7% vs. 34.5%, P = 0.078) therapies compared with current and never smokers.CONCLUSIONS:This study confirms the detrimental effects of smoking in CD, yet failed to demonstrate substantial benefit from smoking in UC. These data should encourage all patients with IBD to quit smoking.
Introduction Anaemia is a common finding in patients with Inflammatory Bowel Disease (IBD). The British Society of Gastroenterology (BSG) has published a comprehensive set of guidelines for approaching this problem in patients with IBD in 2010. The aim of this audit was to evaluate current practice in screening and managing anaemia in IBD patients compared to BSG guidelines standards. Method IBD patients attending clinic and telephone clinics during a 2 week period in July and August 2014 at St. James’s University Hospital, Leeds were assessed retrospectively. Data collection included any haematological tests performed during the preceding year, investigations and therapy for anaemia. Results Monitoring for anaemia during the preceding year occurred in 119 of 122 (98%) eligible patients. 3 patients didn’t have haemoglobin checked annually (one of them due to non-compliance). Of the included 119 patients 56% were female with a median age of 41 years (range 18–80). 49% had a diagnosis of Crohn’s disease and 51% of ulcerative colitis. Anaemia was detected in 33 (24 females, 9 males, 17 Crohns disease, 16 ulcerative colitis) patients (28%). 6 females with anaemia were above the age of 50 and likely post menopausal. Anaemia was significantly more common in female patients (p = 0.038). 15 patients had microcytic hypochromic anaemia, but only 8 patients (53%) had appropriate Iron studies (Ferritin + CRP, followed by Iron + Transferrin saturation + TIBC if indicated) performed as per guidelines. Iron therapy was commenced orally in 4 cases and intravenously in 2 cases. 3 patients (37.5%) with confirmed Iron deficiency Anaemia (IDA) did not receive iron therapy. 5 patients had macrocytic anaemia. In 80% of these Vitamin B12 and folate were checked as per guidelines. Conclusion Anaemia occurs in a third of IBD patients. While monitoring for anaemia was achieved in 98% overall compliance with guidelines was suboptimal. Especially investigations and treatment for iron deficiency anaemia requires further improvement. An emphasis on managing anaemia in IBD patients should be encouraged and appropriate educational measures implemented. Local guidelines for managing anaemia in IBD with a checklist style proforma to be added to patients’ notes may improve adherence to recommendations. Disclosure of interest None Declared. References Guidelines for the management of inflammatory bowel disease in adults Mowat C, Cole A, Windsor A, et al. Gut. 2011
BackgroundAntibiotic-associated diarrhoea (AAD) is a frequent complication of systemic antibiotic therapy and Clostridium difficile-associated diarrhoea (CDAD) is its most serious form due to associated morbidity and mortality.AimThis trial aimed to investigate whether the probiotic VSL#3 prevents AAD and CDAD in average-risk hospital patients.MethodsAdult hospital inpatients exposed to systemic antibiotics were recruited to this multicentre, randomized, double-blind, placebo-controlled trial. One sachet of VSL#3 or placebo was given twice daily for the length of the antibiotics course and for seven days thereafter. Primary outcomes were AAD and CDAD.FindingsPatients randomized to active (N = 117) and placebo (N = 112) groups were well-matched for baseline demographic patient data. No cases of CDAD were detected. The rate of AAD was significantly lower in the active group on per protocol analysis (0% active vs 11.4% placebo; P = 0.006). On intention-to-treat analysis the difference in AAD incidence (4.3% active vs 8.9% placebo; P = 0.19) was not significant.ConclusionsVSL#3 is associated with a significant reduction in the incidence of AAD in average-risk hospital inpatients exposed to systemic antibiotics. As the incidence of CDAD has fallen sharply, no cases of CDAD were found. Probiotic administration as prophylaxis for CDAD may not be indicated in average-risk hospital patients.
Robinson et al. report the effect of adherence and medication switches on relapse.1 Non-adherence to inflammatory bowel disease (IBD) medication is multifactorial, and associated with increased flares and costs.2-4 We recently demonstrated that medication beliefs, but not dosing regimens, predict adherence to 5-aminosalicylates (5-ASAs).5 There has been anecdotal evidence that nonclinical changes in 5-ASA preparations lead to poor adherence and/or flares.6 The authors examined switches within a prescription database, without access to clinical data. By using a proxy measure for relapse (doubling of 5-ASA dose), the authors introduce a nonvalidated tool. While doubling of oral 5-ASA dose is one way of treating flares, some flares are only treated with additional topical 5-ASA. In addition, moderate-to-severe flares requiring glucocorticosteroids will have been missed altogether. As such, the proxy measure cannot be relied upon. Linkage with clinical data is the only way to record flares accurately. It seems arbitrary to simply monitor the effect of switches away from Asacol, but not other 5-ASA preparations. While statistical power is important, the data should have been analysed and reported in full for all 5-ASA preparations. This restriction brings in considerable selection bias. Switches in adherent patients led to an increase in flares, but adherence apparently remained unchanged. Patient confidence in medication is important for adherence,5 and may be adversely affected by switches, but are the authors suggesting that flares were rather due to pharmacological effects? Perhaps the most important message is that medication switches in stable patients may potentially exert an adverse effect. The evidence is however too weak to draw firm conclusions. It is high time for funding bodies to support prospective, high-quality, large-scale studies addressing adherence and switches. Switches intending to save costs could inadvertently lead to poor outcomes, and thus higher costs if adherence were to be adversely affected.7 Declaration of personal interests: Christian Selinger has served as a speaker for MSD and has received research funding from Ferring, Nycomed, Shire and Warner Chilcott. Declaration of funding interests: None.
Inflammatory bowel disease (IBD) often occurs in women of childbearing age and requires complex treatment decision. IBD can have profound influences on fertility, the course of a pregnancy, child birth and lactation. Many women with IBD remain voluntarily childless and patient knowledge of pregnancy related issues is generally poor, which can lead to negative views regarding IBD treatments. To achieve good clinical outcomes for mother and infant a balance has to be struck between the risks of any IBD treatment and the risks of untreated IBD. The advent of the biological age has brought another level of complexity. While more data demonstrating the safe use in pregnancy have recently emerged, effects on infants continue for up to 6 months with important implications on vaccination plans. This review discusses recent advances in the field of IBD and reproduction.