Evidence map›Paper›PMID 29361097›Full record

Trial reportInflammatory bowel diseases2018

Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study.

Aaron Yarlas, Geert D'Haens, Mary Kaye Willian, Megan Teynor

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Inflammatory bowel diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01124149 (A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01124149 phase4completednot on this map

A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

TypeinterventionalSponsorShireRan2010 to 2012Enrolled759ConditionsUlcerative ColitisArmsMMX mesalamine/ mesalazine
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Aaron YarlasOptum, Johnston, RI, United States.
Geert D'HaensInflammatory Bowel Disease Centre, Academic Medical Centre, University of Amsterdam, The Netherlands.
Mary Kaye WillianShire, Wayne, PA, United States.
Megan TeynorShire, Lexington, MA, United States.
Takeda (United States) · USOptum (United States) · USUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Disease activity of patients with ulcerative colitis (UC) predicts health-related quality of life (HRQL) and work-related outcomes (eg, absenteeism, productivity). We tested whether outcomes differed among patients in complete (clinical and endoscopic) remission, partial remission, or not in remission following treatment with multimatrix mesalamine. Methods: Data were from an open-label, multicountry, prospective trial (ClinicalTrials.gov identifier: NCT01124149) of 717 adults with active mild-to-moderate UC treated with 4.8 g/day multimatrix mesalamine tablets for 8 weeks (induction period); 459 patients who achieved partial or complete remission received daily 2.4 g/day multimatrix mesalamine for 12 additional months (maintenance period). HRQL (SF-12v2 Health Survey and Short Inflammatory Bowel Disease Questionnaire) and work-related outcomes (Work Productivity and Activity Impairment questionnaire) were assessed at baseline and final visits of each treatment period. Differences in scores by remission status within each treatment period were tested using analysis of variance and analysis of covariance models, whereas mixed-effects models with repeated measures tested changes over time. Results: At their final visit of each treatment period, patients in partial remission scored significantly better on all HRQL and work-related domains than patients not in remission (all Bonferroni-adjusted P < 0.05). Scores for patients in partial remission were, almost without exception, statistically equivalent to those for patients in complete remission. Fluctuating between complete and partial remission during maintenance treatment had no impact on outcomes. Conclusions: Patients in partial remission following multimatrix mesalamine treatment had HRQL and work-related outcomes equivalent to patients in complete remission. Achievement and maintenance of partial remission may be sufficient for improvements in patients' functioning, well-being, and work performance.

Indexed as

Quality of LifeWork PerformanceAdultAnti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeDrug Administration ScheduleFemaleHealth SurveysHumansInternationalityMaleMesalamineMiddle AgedMultivariate AnalysisProspective StudiesRegression AnalysisAnti-Inflammatory Agents, Non-SteroidalMesalaminehealth-related quality of lifemultimatrix mesalaminepresenteeismulcerative colitiswork-related outcomes

Identifiers

PMID29361097
PMCPMC6176889
OpenAlexW2791812993

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.