Evidence map›Paper›PMID 38874697›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2024

Hypophosphatemia attenuates improvements in vitality after intravenous iron treatment in patients with inflammatory bowel disease.

J B Bjorner, N Kennedy, S Lindgren, R F Pollock

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03466983 (A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03466983 phase4completednot on this map

A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

TypeinterventionalSponsorPharmacosmos A/SRan2018 to 2020Enrolled97ConditionsIBDArmsIron Isomaltoside, Ferric Carboxymaltose
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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.

J B BjornerQualityMetric Incorporated LLC, Johnston, RI, USA.
N KennedyDepartment of Gastroenterology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
S LindgrenDepartment of Gastroenterology and Hepatology, Skåne University Hospital Malmö, Lund University, Lund, Sweden.
R F PollockCovalence Research Ltd, Rivers Lodge, West Common, Harpenden, AL5 2JD, UK. pollock@covalence-research.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIron deficiency anemia is common in people with inflammatory bowel disease (IBD), causing deterioration in quality of life, which can be reversed by treatment that increases iron stores and hemoglobin levels. The present post hoc analyses estimate health state utility values for patients with IBD after treatment with ferric derisomaltose or ferric carboxymaltose and evaluate the health domains driving the changes.

methodsSF-36v2 responses were recorded at baseline and day 14, 35, 49, and 70 from 97 patients enrolled in the randomized, double-blind, PHOSPHARE-IBD trial (ClinicalTrials.gov ID: NCT03466983), in which patients with IBD across five European countries were randomly allocated to either ferric derisomaltose or ferric carboxymaltose. Changes in SF-36v2 scale scores and SF-6Dv2 health utility values were analyzed by mixed models.

resultsIn both treatment arms, SF-6Dv2 utility values and all SF-36v2 scale scores, except Bodily Pain, improved significantly (p =  < 0.0001). The improvement in SF-6Dv2 utility values showed no significant treatment group difference. The improvement in utility values was completely explained by improvement in Vitality scores. Vitality scores showed significantly larger improvement with ferric derisomaltose versus ferric carboxymaltose (p = 0.026). Patients with the smallest decrease in phosphate had significantly larger improvements in Vitality scores at each time point (p =  < 0.05 for all comparisons) and overall (p = 0.0006).

conclusionsUtility values improved significantly with intravenous iron treatment. Improvement in utility values was primarily driven by Vitality scores, which showed significantly greater improvement in the ferric derisomaltose arm. Smaller decreases in phosphate were associated with significantly higher Vitality scores, suggesting that quality of life improvement is attenuated by hypophosphatemia. The utility values can inform future cost-utility analysis.

Indexed as

Anemia, Iron-DeficiencyFerric CompoundsHypophosphatemiaInflammatory Bowel DiseasesQuality of LifeAdministration, IntravenousAdultDouble-Blind MethodEuropeFemaleHumansMaleMaltoseMiddle Agedferric carboxymaltoseFerric CompoundsMaltoseAdministrationInflammatory bowel diseasesIntravenousIronIron deficiency anemiaQuality of life

Identifiers

PMID38874697
PMCPMC11286717

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.