Evidence map›Paper›PMID 34288591›Full record

Trial reportAnnals of clinical and translational neurology2021

Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial.

Timothy J Schultz, Anne Thomas, Paul Georgiou, Mahasen S Juaton, Lynette Cusack, Lorraine Simon, Kerisha Naidoo, Kevin Webb, Jonathan Karnon, Janakan Ravindran

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of clinical and translational neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
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

10 authors at 5 institutions in 1 country.

Timothy J SchultzAdelaide Nursing School, University of Adelaide, Adelaide, South Australia, Australia.ORCID 0000-0003-1419-3328
Anne ThomasPost Op Care at Home (Pty Ltd), Adelaide, South Australia, Australia.
Paul GeorgiouMedical Day Treatment Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Mahasen S JuatonAdelaide Nursing School, University of Adelaide, Adelaide, South Australia, Australia.
Lynette CusackAdelaide Nursing School, University of Adelaide, Adelaide, South Australia, Australia.
Lorraine SimonMedical Day Treatment Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Kerisha NaidooBiogen Australia and New Zealand, Sydney, New South Wales, Australia.
Kevin WebbNeurology & Stroke Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Jonathan KarnonCollege of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
Janakan RavindranNeurology & Stroke Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Royal Adelaide Hospital · AUThe University of Adelaide · AUAmgen (Australia) · AUFlinders University · AUSouth Australia Pathology · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing-remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out-patients' clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs.

methodsIn this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared.

resultsNo adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with "convenience" of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients" out-of-pocket costs.

interpretationThere were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes.

Indexed as

Home Care ServicesOutcome and Process Assessment, Health CareAdultCross-Over StudiesFemaleHumansImmunologic FactorsMaleMiddle AgedMultiple SclerosisNatalizumabPilot ProjectsImmunologic FactorsNatalizumab

Identifiers

PMID34288591
PMCPMC8351394
OpenAlexW3183902143

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.