Evidence map›Paper›PMID 33298112›Full record

SynthesisJournal of translational medicine2020

Can harmonisation of outcomes bridge the translation gap for pre-clinical research? A systematic review of outcomes measured in mouse models of type 2 diabetes.

Nicola L Harman, Adrián Sanz-Moreno, Stamatia Papoutsopoulou, Katie A Lloyd, Kamar E Ameen-Ali, Malcolm Macleod, Paula R Williamson

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. 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

7 authors.

Nicola L HarmanDepartment of Health Data Science, University of Liverpool, Liverpool, L69 3GL, UK. n.harman@liv.ac.uk.ORCID 0000-0001-6958-6466
Adrián Sanz-MorenoGerman Mouse Clinic, Institute of Experimental Genetics, HMGU, Neuherberg, 85764, Germany.ORCID 0000-0001-9478-5432
Stamatia PapoutsopoulouCellular and Molecular Physiology, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.ORCID 0000-0001-6665-8508
Katie A LloydClinical Translational Research Innovation Centre (CTRIC), Altnagelvin Hospital, University of Ulster, Londonderry, BT47 6SB, UK.ORCID 0000-0002-2325-8050
Kamar E Ameen-AliTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, NE4 5PL, UK.ORCID 0000-0002-7583-4099
Malcolm MacleodCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-9187-9839
Paula R WilliamsonDepartment of Health Data Science, University of Liverpool, Liverpool, L69 3GL, UK.ORCID 0000-0001-9802-6636

Funding

Horizon 2020 Framework Programme 654248
6 · The paper itself

Abstract

backgroundIn pre-clinical research, systematic reviews have the potential to mitigate translational challenges by facilitating understanding of how pre-clinical studies can inform future clinical research. Yet their conduct is encumbered by heterogeneity in the outcomes measured and reported, and those outcomes may not always relate to the most clinically important outcomes. We aimed to systematically review outcomes measured and reported in pre-clinical in vivo studies of pharmacological interventions to treat high blood glucose in mouse models of type 2 diabetes.

methodsA systematic review of pre-clinical in vivo studies of pharmacological interventions aimed at addressing elevated blood glucose in mouse models of type 2 diabetes was completed. Studies were screened for eligibility and outcomes extracted from the included studies. The outcomes were recorded verbatim and classified into outcome domains using an existing outcome taxonomy. Outcomes were also compared to those identified in a systematic review of registered phase 3/4 clinical trials for glucose lowering interventions in people with type 2 diabetes.

resultsReview of 280 included studies identified 532 unique outcomes across 19 domains. No single outcome, or domain, was measured in all studies and only 132 (21%) had also been measured in registered phase 3/4 clinical trials. A core outcome set, representing the minimum that should be measured and reported, developed for type 2 diabetes effectiveness clinical trials includes 18 core outcomes, of these 12 (71%) outcomes were measured and reported in one or more of the included pre-clinical studies.

conclusionsThere is heterogeneity of outcomes reported in pre-clinical research. Harmonisation of outcomes across the research pathway using a core outcome set may facilitate interpretation, evidence synthesis and translational success, and may contribute to the refinement of the use of animals in research. Systematic review registration: The study was prospectively registered on the PROSPERO Database, registration number CRD42018106831.

Indexed as

Diabetes Mellitus, Type 2AnimalsMiceResearch DesignTreatment OutcomeClinical researchCore outcome setMouse models of type 2 diabetesPre-clinical researchPre-clinical systematic reviewTranslational researchType 2 diabetes

Identifiers

PMID33298112
PMCPMC7727210

What OpenQuestion holds

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Registered trials

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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.