There has been research in North America to validate the nursing diagnosis of anxiety. As part of this work, Young used the defining characteristics and developed a tool to measure anxiety. The present research sought to extend that study in the United Kingdom, assess the anxiety-defining characteristics tool and identify key indicators of anxiety that might be useful in clinical practice. Four anxiety measurement tools, drawn from the literature, were used. These were the state trait anxiety inventory, the graphic anxiety scale, the hospital anxiety and depression scale, and the anxiety-defining characteristics tool. A random sample of 79 hospitalized patients were interviewed and their anxiety rated using all four measures. Calculation of Spearman's correlation co-efficients revealed convergent validity between the anxiety-defining characteristics tool and the state trait anxiety inventory and the anxiety score on the hospital anxiety and depression scale. Anxiety levels were found not to be affected by the age or sex of the respondent, or the length of stay or number of previous admissions. Discriminant analysis suggested that six characteristics adequately discriminated anxious subjects: sweating, faintness, tendency to blame others, continual review of things in their mind, focus on self and a lack of self-confidence. The study concluded that there is a scope for further research into these characteristics and their use in clinical practice.

SummaryBackgroundSignificant associations between serum golimumab concentrations and favourable outcomes have been observed during both induction and maintenance therapy in ulcerative colitis (UC). However, data regarding optimal therapeutic serum golimumab concentration thresholds are limited.AimsTo identify optimal serum golimumab concentration thresholds during induction and maintenance treatment with golimumab.MethodsGO‐LEVEL was an open label, phase IV study that included a prospective cohort of UC patients commencing golimumab, as well as a cross‐sectional cohort receiving maintenance treatment. Patients commencing induction for active UC (defined as a simple clinical colitis activity index [SCCAI] >5 in addition to a raised faecal calprotectin [FC] >59μg/g or, raised C‐reactive protein [CRP] [>5mg/L] or, Mayo endoscopic disease activity 2 or 3) were evaluated at weeks 6, 10 and 14. Patients receiving maintenance therapy were recruited either at the point of flare or during remission. Combined clinical‐biochemical remission was defined as SCCAI ≤2 and FC <250μg/g. Serum golimumab concentrations were measured using a commercially available ELISA (LISATRACKER, Theradiag).ResultsThirty‐nine patients were included in the induction cohort, of whom 15 (38%) achieved combined clinical‐biochemical remission at week 6. The median serum golimumab concentration of those in combined clinical‐biochemical remission was significantly higher than those who were not (5.0 vs 3.1 μg/mL, respectively, P = 0.03). Receiver operating characteristic (ROC) curve analysis demonstrated 3.8 μg/mL as the optimal threshold (sensitivity 0.71, specificity 0.65, area under curve [AUC] 0.72, positive predictive value [PPV] 0.59 and negative predictive value [NPV] 0.79). Sixty‐three patients were included in the maintenance cohort; 31 (49%) were in combined remission, 32 (51%) were not. The median serum golimumab concentration of those in combined remission was significantly higher (2.9 vs 2.1 μg/mL, respectively, P = 0.01). ROC curve analysis demonstrated 2.4 μg/mL as the optimal threshold (sensitivity 0.68, specificity 0.66, AUC 0.68, PPV 0.65 and NPV 0.66).ConclusionsGO‐LEVEL (NCT03124121) offers further evidence regarding golimumab's exposure‐response relationship. Clinicians may consider using therapeutic drug monitoring to optimise golimumab dosing aiming to achieve our suggested therapeutic thresholds of 3.8 μg/mL at week 6 and 2.4 μg/mL during maintenance.

Metabolite testing resulted in a change in management in most patients not responding to thiopurines or experiencing adverse events. Weight-based dosing did not increase rates of therapeutic levels but was associated with increased 6MMP shunting.

BackgroundThis study aimed to characterize prevalence of anxiety and depressive conditions and uptake of mental health services in an Australian inflammatory bowel disease (IBD) outpatient setting.MethodsEighty-one IBD patients (39 males, mean age 35 years) attending a tertiary hospital IBD outpatient clinic participated in this study. Disease severity was evaluated according to the Manitoba Index. Diagnosis of an anxiety or depressive condition was based upon the Mini-International Neuropsychiatric Interview and the Hospital Anxiety and Depression Scale.ResultsBased on Hospital Anxiety and Depression Scale subscale scores >8 and meeting Mini-International Neuropsychiatric Interview criteria, 16 (19.8%) participants had at least one anxiety condition, while nine (11.1%) had a depressive disorder present. Active IBD status was associated with higher prevalence rates across all anxiety and depressive conditions. Generalized anxiety was the most common (12 participants, 14.8%) anxiety condition, and major depressive disorder (recurrent) was the most common depressive condition reported (five participants, 6.2%). Seventeen participants (21%) reported currently seeking help for mental health issues while 12.4% were identified has having at least one psychological condition but not seeking treatment.ConclusionWe conclude that rates of anxiety and depression are high in this cohort, and that IBD-focused psychological services should be a key component of any holistic IBD service, especially for those identified as having active IBD.

The era of biologic agents for the treatment of Crohn’s disease has brought about significant benefits for patients, and since the introduction of infliximab at the turn of the century, the entire field has moved on rapidly. Clinicians now have multiple agents at their disposal and a choice between several different anti-inflammatory mechanisms of action. This has allowed unprecedented improvements not only in symptoms and quality of life for patients previously refractory to conventional treatments but also for demonstrated healing of the intestinal mucosa and resolution of perianal fistulation. However, despite the undisputed efficacy of these agents, there remains a significant proportion of patients who fail to gain a meaningful benefit. Through years of studying infliximab and its counterpart anti-tumour necrosis factor (anti-TNF) agent, adalimumab, we now understand that strategies such as combining use with a conventional immunomodulator or measuring serum levels can help to optimise outcomes and reduce the proportion of patients for whom treatment fails. Work is ongoing to understand whether these principles apply to newer biologics such as vedolizumab and ustekinumab. In addition, novel approaches are being investigated in an attempt to maximise the benefit that these agents could offer. In this article, we summarise these new understandings and consider ways in which they could be integrated into clinical practice for the benefit of patients.

Patients with greater inflammatory bowel disease activity readily identify poorer psychosocial outcomes; however, the role of gender, disease type, and individual illness perceptions facets are less well known. This study aimed to characterize the role of illness perceptions, gender, and disease type on anxiety, depression, and quality of life. Eighty-one patients diagnosed with inflammatory bowel disease (39 men, mean age 35 years) attending a tertiary hospital outpatient clinic were studied. Questionnaires used included the Manitoba Index, the Brief Illness Perceptions Questionnaire, Hospital Anxiety and Depression Scale, and the World Health Organization Brief Quality of Life Scale. Female patients with active disease tended to report increased anxiety, depression, and reduced quality of life. Regarding illness perceptions, patients with Crohn disease reported significantly more concerns about its chronicity, while female patients reported being significantly more concerned about the impact of their illness on identity, chronicity, overall concern, and having a greater emotional impact. Hierarchical regression indicated that 36% of depression, 42% of anxiety, and 57% of quality of life could be accounted for by disease activity and type, gender, and illness perceptions. The findings suggest that in addition to a patient's perceived disease status, gastroenterology nurses should also be aware that patient gender and their perceptions of illness play a significant impact not only on anxiety and depression but also on quality of life. Increased disease activity is associated with more severe anxiety and depression and reduced quality of life. Female patients are also at a greater risk of reporting negative illness perceptions and increased levels of anxiety, depression, and lower quality of life.

BackgroundDespite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn’s disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited.ObjectivesWe evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy.MethodsWe performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3.ResultsA total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0–11) at baseline to 4 (0–6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0–27) and 3 (0–8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1–23) to 2 mg/L (1–17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response.ConclusionsOur findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.

Thiopurines are a cheap, effective treatment option in the management of inflammatory bowel disease (IBD). However, with the growing choice of targeted therapies available, as well as the well-documented toxicities of thiopurines, the role of thiopurines has been questioned. Nevertheless, given their inexpense in an era of spiraling healthcare costs, thiopurines remain an attractive option in the right patients. In the age of personalized medicine, being able to predict patients who will respond as well as those that will develop toxicity to a treatment is vital to tailoring therapy. This review will summarize the available literature with respect to predictors of response and toxicity to thiopurines in order to guide management in IBD. Specifically, toxicities addressed will include myelotoxicity, hepatotoxicity, pancreatitis, alopecia, gastrointestinal and flu-like symptoms, and complications associated with Epstein-Barr virus. While more work needs to be done to further our ability to predict both response to and side effects from therapies, pharmacogenomic research shows significant promise in its ability to personalize our use of thiopurines.