Evidence map›Paper›PMID 26491080›Full record

ArticleScience translational medicine2015

Impact of guidance documents on translational large animal studies of cartilage repair.

Christian G Pfeifer, Matthew B Fisher, James L Carey, Robert L Mauck

Open access · greenAbstract read
In one paragraph

Article in Science translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 14% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Cartilage Tissue Engineering: An Introduction.Methods in molecular biology (Clifton, N.J.) · 2023
    Article
  6. Article
  7. Review
  8. Article
  9. Editorial: Post-Traumatic Osteoarthritis After Meniscus Injury.Frontiers in bioengineering and biotechnology · 2022
    Article
  10. Review
  11. Article
  12. Biomaterials to Mimic and Heal Connective Tissues.Advanced materials (Deerfield Beach, Fla.) · 2019
    Review
  13. Article
  14. Review
  15. Article
  16. 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

4 authors at 1 institution in 1 country.

Christian G PfeiferMcKay Orthopaedic Research Laboratory, Department of Orthopaedic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. Translational Musculoskeletal Research Center, Philadelphia Veterans Affairs Medical Center, Philadelphia, PA 19104, USA. Department of Trauma Surgery, Regensburg University Medical Center, 93053 Regensburg, Germany.
Matthew B FisherMcKay Orthopaedic Research Laboratory, Department of Orthopaedic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. Translational Musculoskeletal Research Center, Philadelphia Veterans Affairs Medical Center, Philadelphia, PA 19104, USA. Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, and North Carolina State University, Raleigh, NC 27695, USA.
James L CareyMcKay Orthopaedic Research Laboratory, Department of Orthopaedic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. Translational Musculoskeletal Research Center, Philadelphia Veterans Affairs Medical Center, Philadelphia, PA 19104, USA.
Robert L MauckMcKay Orthopaedic Research Laboratory, Department of Orthopaedic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. Translational Musculoskeletal Research Center, Philadelphia Veterans Affairs Medical Center, Philadelphia, PA 19104, USA. Department of Bioengineering, University of Pennsylvania, Philadelphia, PA 19104, USA. Collaborative Research Partner, Acute Cartilage Injury Program of the AO Foundation, 7270 Davos, Switzerland. lemauck@mail.med.upenn.edu.
University of Pennsylvania · US

Funding

Engineering Developmental Microenvironments: Cartilage Formation and MaturationR01EB008722 · NIBIB · UNIVERSITY OF PENNSYLVANIA · PI BURDICK, JASON A, MAUCK, ROBERT L · 2009 to 2017
$3.0M
Cartilage repair with stem-cell laden hyaluronic acid hyrogelsI01RX000700 · VA · PHILADELPHIA VA MEDICAL CENTER · PI STEINBERG, DAVID · 2012 to 2015
–
NIBIB NIH HHS R01 EB008722RRD VA I01 RX000700
6 · The paper itself

Abstract

Promising therapies for cartilage repair are translated through large animal models toward human application. To guide this work, regulatory agencies publish recommendations ("guidance documents") to direct pivotal large animal studies. These are meant to aid in study design, outline metrics for judging efficacy, and facilitate comparisons between studies. To determine the penetrance of these documents in the field, we synthesized the recommendations of the American Society for Testing and Materials, U.S. Food and Drug Administration, and European Medicines Agency into a scoring system and performed a systematic review of the past 20 years of preclinical cartilage repair studies. Our hypothesis was that the guidance documents would have a significant impact on how large animal cartilage repair studies were performed. A total of 114 publications meeting our inclusion criteria were reviewed for adherence to 24 categories extracted from the guidance documents, including 11 related to study design and description and 13 related to study outcomes. Overall, a weak positive trend was observed over time (P = 0.004, R(2) = 0.07, slope = 0.63%/year), with overall adherence (the sum of study descriptors and outcomes) ranging from 32 ± 16% to 58 ± 14% in any individual year. There was no impact of the publication of the guidance documents on adherence (P = 0.264 to 0.50). Given that improved adherence would expedite translation, we discuss the reasons for poor adherence and outline approaches to increase and promote their more widespread adoption.

Indexed as

Models, AnimalTranslational Research, BiomedicalAnimalsCartilageUnited StatesUnited States Food and Drug Administration

Identifiers

PMID26491080
PMCPMC5802867
OpenAlexW2109784166

What OpenQuestion holds

Textmetadata
LicenceTDM
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.