Evidence map›Paper›PMID 37077323›Full record

ArticleHealth services insights2023

Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials.

Caroline Kamp Jørgensen, Markus Harboe Olsen, Niklas Nielsen, Theis Lange, Lawrence Mbuagbaw, Lehana Thabane, Laurent Billot, Nadine Binder, Silvio Garattini, Rita Banzi and 9 more

Open access · goldAbstract read
In one paragraph

Article in Health services insights, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 94% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

19 authors at 10 institutions in 8 countries.

Caroline Kamp JørgensenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-7756-4694
Markus Harboe OlsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Niklas NielsenDepartment of Clinical Sciences, Faculty of Medicine, Lund University, Sweden.
Theis LangeDepartment of Public Health/Section of Biostatistics, Copenhagen University, Copenhagen, Denmark.
Lawrence MbuagbawDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Laurent BillotThe George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Nadine BinderDepartment of Data Driven Medicine, Institute of General Practice/Family Medicine, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Silvio GarattiniIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Rita BanziIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Jacques DemotesECRIN European Clinical Research Infrastructure Network, Paris, France.
Elena BiagioliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Eliana RulliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Guido BertoliniIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Giovanni NattinoIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Ole MathiesenCentre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Valter TorriIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Mario Negri Institute for Pharmacological Research · ITUniversity of Southern Denmark · DKUniversity of Copenhagen · DKCopenhagen University Hospital · DKEuropean Clinical Research Infrastructure Network · FRImpact · CALund University · SEUniversity of Freiburg · DEUniversity of Johannesburg · ZAUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology is already at a very high standard, there are many trials that deliver biased results due to the implementation of inadequate methodology, poor data quality and erroneous or biased analyses. To increase the internal and external validity of randomised clinical trial results, several international institutions within clinical intervention research have formed The Centre for Statistical and Methodological Excellence (CESAME). Based on international consensus, the CESAME initiative will develop recommendations for the proper methodological planning, conduct and analysis of clinical intervention research. CESAME aims to increase the validity of randomised clinical trial results which will ultimately benefit patients worldwide across medical specialities. The work of CESAME will be performed within 3 closely interconnected pillars: (1) planning randomised clinical trials; (2) conducting randomised clinical trials; and (3) analysing randomised clinical trials.

Indexed as

biostatisticscentre of excellenceconsortiummethodologyRandomised clinical trials

Identifiers

PMID37077323
PMCPMC10107963
OpenAlexW4364860643

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.