Evidence map›Paper›PMID 27362533›Full record

Trial reportPloS one2016

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries.

Erwin De Cock, Persefoni Kritikou, Mariana Sandoval, Sunning Tao, Christof Wiesner, Angelo Michele Carella, Charles Ngoh, Tim Waterboer

2 registry-linked trialsOpen access · goldAbstract readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 57 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 1 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT01200758 phase3completednot on this map

A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2017Enrolled410ConditionsNon-Hodgkin's LymphomaArmsRituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine
NCT01461928 phase3completednot on this map

A Randomized Study Comparing Maintenance Therapy With Subcutaneous Rituximab Continued Until Progression With Observation Only in Patients With Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma Who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2018Enrolled692ConditionsNon-Hodgkin's LymphomaArmsChemotherapy (Induction Period), Rituximab
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 1 synthesis or guideline pooled it, 102 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

8 authors at 3 institutions in 3 countries.

Erwin De CockUnited Biosource Corporation, Barcelona, Spain.
Persefoni KritikouUnited Biosource Corporation, London, United Kingdom.
Mariana SandovalUnited Biosource Corporation, Montreal, Canada.
Sunning TaoUnited Biosource Corporation, Montreal, Canada.
Christof WiesnerGenentech Inc., South San Francisco, California, United States of America.
Angelo Michele CarellaIRCSS AOU, San Martino, Italy.
Charles NgohF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Tim WaterboerF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Roche (Switzerland) · CHOspedale Policlinico San Martino · ITUnited BioSource Corporation (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings.

methodsThis non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient's first year of treatment (11 rituximab sessions).

resultsMean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27-58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1-5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53-91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1-5.5 eight-hour days.

conclusionsCompared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units.

trial registrationClinicalTrials.gov NCT01200758.

Indexed as

Antineoplastic AgentsHumansInfusions, IntravenousInjections, SubcutaneousLymphoma, Non-HodgkinRituximabTime and Motion StudiesTime FactorsTreatment OutcomeAntineoplastic AgentsRituximab

Identifiers

PMID27362533
PMCPMC4928781
OpenAlexW2472310215

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.