Evidence map›Paper›PMID 33209948›Full record

ArticleOpen forum infectious diseases2020

Clinical Trials Increase Off-Study Drug Use: A Segmented Time-Series Analysis.

Guillaume Butler-Laporte, Matthew P Cheng, Daniel J G Thirion, Samuel De L'Étoile-Morel, Charles Frenette, Katryn Paquette, Alexander Lawandi, Emily G McDonald, Todd C Lee

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 22% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Antibiotic synergy againstAntimicrobial agents and chemotherapy · 2025
    Pooled it
  3. On the Treatment ofOpen forum infectious diseases · 2021
    Review
  4. 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

9 authors at 1 institution in 1 country.

Guillaume Butler-LaporteDivision of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.ORCID 0000-0001-5388-0396
Matthew P ChengDivision of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.ORCID 0000-0002-4867-2063
Daniel J G ThirionFaculté de Pharmacie, Université de Montréal, Montréal, Québec, Canada.
Samuel De L'Étoile-MorelDivision of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.
Charles FrenetteDivision of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.
Katryn PaquetteDivision of Neonatology, Department of Pediatrics, McGill University Health Centre, Montréal, Québec, Canada.
Alexander LawandiDivision of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.ORCID 0000-0001-7948-3161
Emily G McDonaldDivision of General Internal Medicine, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.
Todd C LeeDivision of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.
McGill University Health Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effect of participation in a clinical trial on concomitant off-study investigational drug use has not been described. We sought to determine if participation in the Daptomycin as Adjunctive Therapy for

methodsWe retrospectively analyzed daptomycin use for 8 years preceding the trial, off-study daptomycin use during the trial itself (31 months), and daptomycin use for 6 fiscal months after trial completion. We used a segmented linear regression analysis of an interrupted time series to analyze changes in each drug's defined daily doses (DDD) per 1000 patient-days. As a control, we analyzed use of linezolid over these periods and also accounted for rates of methicillin-resistant

resultsFor 1.5 years before the DASH trial, daptomycin use was decreasing by -0.30 DDD per 1000 patient-days per fiscal period (95% CI, -0.52 to -0.07). Following the initiation of the study, there was a statistically significant increase in daptomycin use of 0.28 DDD per 1000 patient-days per fiscal period (95% CI, 0.03 to 0.52), despite low, stable rates of MRSA and VRE infections. Following trial completion, daptomycin use decreased back toward prestudy rates. Use of linezolid remained stable throughout.

conclusionsDespite the DASH trial being a negative study, it impacted the prescribing habits of local clinicians during recruitment. Trialists should be aware of potential off-target study effects, and prescribers should be wary of early uptake of interventions before definitive study results.

Indexed as

daptomycinoff-label prescribingrandomized controlled trialStaphylococcus aureus

Identifiers

PMID33209948
PMCPMC7651655
OpenAlexW3087912192

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.