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The impact of biological interventions for ulcerative colitis on health-related quality of life

Overview of attention for article published in Cochrane database of systematic reviews, September 2015
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  • Good Attention Score compared to outputs of the same age (75th percentile)

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Citations

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Title
The impact of biological interventions for ulcerative colitis on health-related quality of life
Published in
Cochrane database of systematic reviews, September 2015
DOI 10.1002/14651858.cd008655.pub3
Pubmed ID
Authors

Katie LeBlanc, Mahmoud H Mosli, Claire E Parker, John K MacDonald

Abstract

Ulcerative colitis (UC) is a chronic inflammatory disorder of the colon that has a relapsing-remitting course. Health related quality of life (HRQL) is significantly lower in patients with UC than the general population due to the negative effects of the disease on physical, psychological and social well-being. Randomized controlled trials (RCTs) evaluating medical interventions for UC have traditionally used clinical disease activity indices that focus on symptoms to define primary outcomes such as clinical remission or improvement. However, this approach does not evaluate benefits that are highly relevant to patients such as HRQL OBJECTIVES: The primary objective was to assess the impact of biologic therapy on the HRQL of UC patients. We searched PubMed, MEDLINE, EMBASE and CENTRAL from inception to September, 2015. Conference abstracts and reference lists were also searched. RCTs that compared biologics to placebo in UC patients and reported on HRQL using the Inflammatory Bowel Disease Questionnaire (IBDQ), or the SF-36 or EQ-5D to measure HRQL were included. Two authors independently screened studies for inclusion, extracted data and assessed study quality using the Cochrane risk of bias tool. The primary outcome was improvement in HRQL. For dichotomous outcomes we calculated the risk ratio (RR) and 95% confidence interval (CI). For continuous outcomes we calculated the mean difference (MD) and 95% CI. The overall quality of the evidence supporting the primary outcome was assessed using GRADE. Nine RCTs (n = 4143) were included. Biologics included rituximab (one small study), interferon-ß-1a (one study), vedolizumab (one study), and the tumor necrosis factor-alpha (TNF-α) antagonists infliximab (two studies), adalimumab (three studies), and golimumab (one study). Risk of bias was low in eight studies. The rituximab study was judged to be at high risk of bias due to attrition bias. The studies comparing interferon-ß-1a and rituximab to placebo found no clear evidence of a difference in the proportion of patients who experienced an improvement in HRQL at 8 or 12 weeks respectively. The proportion of patients with a clinically meaningful improvement in HRQL at 6 or 52 weeks was significantly higher in vedolizumab patients compared to placebo. At 6 weeks 37% (83/225) of vedolizumab patients had an improvement in IBDQ score of at least 16 points from baseline compared to 23% (34/149) of placebo patients (RR 1.62, 95% CI 1.15 to 2.27; 1 study). At 52 weeks, 64% (157/247) of vedolizumab patients had an improvement in IBDQ score of at least 16 points from baseline compared to 38% (48/126) of placebo patients (RR 1.62, 95% CI 1.15 to 2.27; 1 study). A GRADE analysis indicated that the overall quality of the evidence supporting these outcomes was moderate due to sparse data (< 400 events). Patients who received maintenance vedolizumab every eight weeks had significantly higher mean SF-36 scores than placebo patients at 52 weeks (MD 3.40, 95% CI 1.56 to 5.24, 1 study 248 patients). This difference appears to be clinically meaningful as the lower boundary for a clinically meaningful change in SF-36 is three points. A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was moderate due to sparse data (< 400 events). Adalimumab patients had significantly higher mean IBDQ scores than placebo patients at weeks 8 (MD 9.00, 95% CI 2.65 to 15.35; 1 study, 494 patients) and 52 (MD 8.00, 95% CI 0.68 to 15.32; 1 study, 494 patients). However, these differences may not be clinically meaningful as the lower boundary for a clinically meaningful change in IBDQ is 16 points. A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was moderate due to sparse data (< 400 events). Golimumab patients who received a dose of 200/100 mg (MD 12.20, 95% CI 6.52 to 17.88; 504 patients) or 400/200 mg (MD 12.10, 95% CI 6.40 to 17.80; 508 patients) had significantly higher mean IBDQ scores than placebo patients at week 6. Although a GRADE analysis indicated that the overall quality of the evidence supporting these outcomes was high, the difference in IBDQ scores may not be clinically meaningful. Infliximab patients had significantly higher mean IBDQ scores at week 6 or 8 than placebo patients (MD 18,58, 95% CI 13.19 to 23.97; 2 studies, 529 patients). This difference in HRQL is clinically meaningful. A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was high. The proportion of patients with a clinically meaningful improvement in HRQL at eight weeks was significantly higher in infliximab patients compared to placebo. Sixty-nine per cent (333/484) of infliximab patients had an improvement in IBDQ score of > 16 points from baseline compared to 50% of placebo patients (RR 1.39, 95% CI 1.21 to 1.60; 1 study). A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was high. Similar results were found between infliximab and placebo when HRQL was measured using the SF-36 instrument. One small study (n = 43) found no difference in HRQL between infliximab and placebo when measured by the EQ-5D. Pooled analyses of TNF-α antagonists showed a benefit in HRQL favouring TNF-α over placebo. These results suggest that biologics have the potential to improve HRQL in UC patients. High quality evidence suggests that infliximab provides a clinically meaningful improvement in HRQL in UC patients receiving induction therapy. Moderate quality evidence suggests that vedolizumab provides a clinically meaningful improvement in HRQL in UC patients receiving maintenance therapy. These findings are important since there is a paucity of effective drugs for the treatment of UC that have the potential to both decrease disease activity and improve HRQL. More research is needed to assess the long-term effect of biologic therapy on HRQL in patients with UC. More research is needed to assess the impact of golimumab and adalimumab on HRQL in UC patients. Trials involving direct head to head comparisons of biologics would help determine which biologics provide optimum benefit for HRQL.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 122 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Chile 1 <1%
Unknown 121 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 28 23%
Student > Bachelor 17 14%
Researcher 16 13%
Student > Ph. D. Student 13 11%
Student > Postgraduate 8 7%
Other 24 20%
Unknown 16 13%
Readers by discipline Count As %
Medicine and Dentistry 59 48%
Nursing and Health Professions 9 7%
Psychology 9 7%
Pharmacology, Toxicology and Pharmaceutical Science 6 5%
Social Sciences 5 4%
Other 15 12%
Unknown 19 16%

Attention Score in Context

This research output has an Altmetric Attention Score of 5. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 28 November 2018.
All research outputs
#3,514,677
of 13,935,576 outputs
Outputs from Cochrane database of systematic reviews
#6,243
of 10,765 outputs
Outputs of similar age
#61,922
of 252,130 outputs
Outputs of similar age from Cochrane database of systematic reviews
#187
of 262 outputs
Altmetric has tracked 13,935,576 research outputs across all sources so far. This one has received more attention than most of these and is in the 74th percentile.
So far Altmetric has tracked 10,765 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 21.4. This one is in the 41st percentile – i.e., 41% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 252,130 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 75% of its contemporaries.
We're also able to compare this research output to 262 others from the same source and published within six weeks on either side of this one. This one is in the 28th percentile – i.e., 28% of its contemporaries scored the same or lower than it.