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Background and Aim: Normalizing health‐related quality of life (QoL) and fatigue are important long‐term treatment targets in inflammatory bowel disease (IBD). We examined their evolution in relation to changes in disease activity during vedolizumab therapy. Methods: Cohort study of biologically refractory IBD patients treated with vedolizumab. Patients were prospectively evaluated at all infusions by Short Health Scale (SHS) (QoL questionnaire covering four health dimensions) (n = 79), visual analogous scale for fatigue (VAS‐F) (n = 30), and clinical disease activity. Objective disease assessment was carried out after 1 year or at treatment failure. Results: Patients in steroid‐free clinical remission at end of induction improved significantly in all SHS items already from week 2 with full implementation by week 14 ("Symptoms" 59% improvement, P < 0.001; "Function" 63%, P < 0.001; "Worries" 59%, P < 0.001; "Well‐being" 40%, P < 0.01). Then, SHS remained stable at background levels (< 20) for 1 year (improvements 67%; 65%; 62%; 57%; P < 0.001). Combined clinical‐objective remission at 1 year was associated with highest SHS improvements (64–72%; P < 0.001). Of note, early SHS improvements preceded manifestation of clinical remission in most patients (22 of 33; 67%). Clinical response materialized into late (week 6 or later) and minor SHS improvements (31–46%, P < 0.001). Fatigue improved steadily over 6 months to background levels (VAS‐F < 4) among patients in clinical remission (45% decrease) or clinical‐objective remission (41%). SHS and VAS‐F impairment remained elevated in patients without effect of therapy. Conclusion: QoL rapidly improves and predicts later significant clinical‐objective efficacies of vedolizumab at end of induction and 1 year. Fatigue improves slowly after remission is attained. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQoL) is impaired in patients with Crohn's disease (CD). This study aimed to identify the impact of clinical disease activity on HRQoL in CD patients treated with biological agents. Patients with moderate to severe active CD treated with biological agents in Denmark were included from 2016–2018. Disease related symptoms were assessed via the Harvey Bradshaw Index. HRQoL was measured on the Short Health Scale (SHS). Multivariable linear regression models were conducted separately for each SHS item and average SHS score stratified for sex, adjusting for clinical manifestation and age. In total, 1,181 CD patients were included. The mean age was 33 years and 56% were women. Abdominal pain (range of regression coefficients 1.18–1.42), number of liquid stools (0.33–0.58), and the appearance of a new rectal fistula (0.91–1.32) affected all domains in the SHS negatively for men and women. Arthralgia (0.47–0.67) and abdominal mass (0.54–0.62) affected 4 out of 5 items on SHS negatively for women and men, respectively. Female sex was found a predictor of lower HRQoL across all SHS items, whereas age and fistulizing disease, as phenotype, were not associated with lower HRQoL. Abdominal pain, number of liquid stools, a new rectal fistula, arthralgia for women, clinically assessed abdominal mass for men as well as female sex, were all found to be predictors of decreased HRQoL. [ABSTRACT FROM AUTHOR]

Background and aims: Patients with ulcerative colitis have reduced health-related quality of life compared to the general population. Current treatment strategy aims to reduce patients' symptoms and increase health-related quality of life. We investigated which symptoms of ulcerative colitis correlate to decreased health-related quality of life. Methods: Among 743 patients with moderate to severely active ulcerative colitis receiving biological therapy in a cross-sectional national study, we determined which disease-related symptoms, as measured by the Simple Clinical Colitis Activity Index, worsened health-related quality of life scores across the Short Health Scale dimensions, while adjusting for treatment, age, and clinical manifestation, and stratifying for sex, by means of multiple linear regression. Results: Patients with active disease had decreased health-related quality of life compared to those with inactive disease (median 5.8 (range 4.5–7.5) vs. 2 (0.8–3.3)). Both sexes had decreased health-related quality of life in all dimensions for the symptoms: bowel frequency during daytime (0.37–0.86 and 0.46–0.84), urgency of defecation (0.54–0.79 and 0.49–0.65) and blood in stool (0.50–0.75 and 0.36–0.54) for men and women respectively. Women were more often negatively affected by bowel frequency during night-time (4 domains vs. 1) and arthritis (5 domains vs. 3). In non-stratified analysis female sex is an independent predictor of lower health-related quality of life for 3 domains (0.38–0.53). Conclusions: Health-related quality of life was most prominently associated with bowel frequency during daytime, urgency of defecation, and blood in stool. Other symptoms associated for some health-related quality of life dimensions, and appear to vary between the sexes. [ABSTRACT FROM AUTHOR]

Objectives: Patient reported outcomes are widely used in today's clinical practice. The Short Health Scale has been proven to be an easy-to-use and reliable measure to evaluate quality of life in patients with inflammatory bowel disease. We aimed to validate this Short Health Scale in Dutch speaking patients. Methods: A total of 157 Crohn's disease and ulcerative colitis patients (46% male, median age 39 years) completed the Short Health Scale on a tablet during the outpatient clinic. Validity was assessed by correlating both individual and total Short Health Scale scores with short Inflammatory Bowel Disease Questionnaire dimensions and clinical disease activity. Test-retest reliability was assessed in eight patients in stable remission who completed the Short Health Scale a second time after 4–8 weeks. Results: All Short Health Scale items correlated with corresponding short Inflammatory Bowel Disease Questionnaire dimensions (correlation coefficients ranging from −0.403 to −0.833, all p <.01). Short Health Scale scores increased stepwise with increasing clinical disease activity (all p <.001). The results of the Short Health Scale questionnaire remained stable on repeated measurements in patients in remission (rs between 0.699 and 0.994, all p <.01 except for well-being). Conclusions: The Short health Scale is a rapid and valid instrument for measuring quality of life in Dutch speaking patients with Inflammatory Bowel Disease. Its simplicity and usability make it a good candidate for routine care and suitable for home-monitoring of patients. [ABSTRACT FROM AUTHOR]

Purpose: The aims of this study were to investigate the psychometric properties of the Norwegian version of the Short Health Scale (SHS), and to study the impact of socio-demographic and clinical data. Methods: A total of 140 patients without severe disease activity were included. The participants completed the SHS and three other well-validated HRQoL questionnaires Short Form 36, Inflammatory Bowel Disease Questionnaire and the Rating Form of Inflammatory Bowel Disease Patient Concerns at the baseline. Sixty-three participants completed the SHS at a second visit after 6 months in order to calculate test-retest reliability and responsiveness. In addition, socio-demographic and clinical variables were obtained and entered into a linear regression analysis if they were found to be significantly associated with SHS outcome. Results: Validity was confirmed by good correlation with other similar HRQoL constructs and the ability to discriminate between IBD symptom scores. The reliability was strong (Cronbach's α 0.85). The test-retest reliability in three out of four SHS items was weak, but the questionnaire demonstrated a good responsiveness. Current IBD symptoms were the most important predictor of SHS outcome. Conclusions: The Norwegian SHS demonstrated satisfactory psychometrical properties and is suitable for use in the follow-up of IBD patients. [ABSTRACT FROM AUTHOR]

Aim The study aimed to assess quality of life (QoL) in patients with a sigmoid colostomy using a simple general and disease-specific instrument. A subgroup not doing well was identified and examined further. Method The Short Health Scale (SHS) is a four-item instrument exploring severity of symptoms, function in daily life, worry, and general well-being, using visual analogue scales ranging from 0 to 100 where 100 is the worst possible situation. The SHS was delivered to 206 patients with a sigmoid colostomy. It was returned by 181 (87.9%) patients [88 men; median age 73 (33-91) years]. Follow-up was 61 (10-484) months for 178 (86.4%) patients returning usable questionnaires. A subgroup of 16 patients scoring more than 50 in all four items of the SHS was further examined with StomaQOL where 100 is best possible. Results The median score for severity of symptoms was 18 (2-95), function in daily life 21 (0-95), worry 17 (3-98) and general well-being 22 (0-99). A score of < 50 in the SHS was recorded in 84.9%, 82.1%, 79.9% and 70.5% respectively. In the group scoring more than 50 in all four items patients diagnosed with irritable bowel syndrome constituted 43.8% to compare with 5.6% in the entire study group ( P < 0.001). Median score for StomaQOL was 37 (22-62) in this group. Conclusion Most patients with a permanent sigmoid colostomy have a good QoL consistent with previous findings. However, this is reduced in a subgroup of patients diagnosed with irritable bowel syndrome. [ABSTRACT FROM AUTHOR]