Acting on black box warnings requires a GRADE evidence table and an implementation guide: the case of teriparatide

Journal of Clinical Epidemiology
Tarig ElraiyahMohammad Hassan Murad

Abstract

To assess how well do the black box warnings present and communicate evidence in a way that is consistent with evidence-based patient-centered practice, through evaluating the boxed warning on teriparatide-induced osteosarcoma. We critically appraised teriparatide black box warning for osteosarcoma by reviewing human and animal studies that were used as basis for the warning. We also evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. We found that this warning was based on very low-quality evidence that was derived primarily from animal studies. The quality of evidence was rated down because of high risk of bias in addition to inconsistency, indirectness, and imprecision of the estimates. The warning does not provide sufficient guidance for practice like an implementation tool or an evidence profile to clarify the limitations of the evidence. Black box warning for teriparatide-associated osteosarcoma does not explicitly present the quality of evidence, and therefore, it could be of limited use in evidence-based practice. We propose that black box warnings should include an evidence profile and an implementation guide to be more useful in evidence-based pa...Continue Reading

References

Feb 24, 2001·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·M SatoC H Turner
Jul 13, 2006·Journal of the American Academy of Child and Adolescent Psychiatry·Randall D MarshallLawrence Greenhill
Dec 4, 2008·JAMA : the Journal of the American Medical Association·M Hassan MuradGordon H Guyatt
Jul 15, 2009·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·V SubbiahJ A Ludwig
Oct 27, 2009·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Jill P KarpelPaula J Anderson
Mar 3, 2010·The Journal of Bone and Joint Surgery. American Volume·Aasis UnnanuntanaJoseph M Lane
Jan 7, 2011·Journal of Clinical Epidemiology·Howard BalshemGordon H Guyatt
May 25, 2011·The American Journal of Medicine·Victor M MontoriRobert A Wermers
Jun 15, 2011·Journal of Gerontological Nursing·Kelly R Ragucci, Sarah P Shrader
Sep 20, 2012·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Elizabeth B AndrewsDaniel Masica
Nov 21, 2012·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Cristiana CiprianiJohn P Bilezikian

❮ Previous
Next ❯

Citations

Sep 1, 2015·Journal of Clinical Epidemiology·Tarig ElraiyahMohammad Hassan Murad
Jan 10, 2017·Expert Opinion on Biological Therapy·Leonardo BandeiraJohn P Bilezikian
Sep 29, 2017·Drugs -- Real World Outcomes·Kanika AnandJohn-Michael Gamble
Aug 7, 2018·Current Opinion in Neurology·Claire L Wood, Volker Straub
Sep 8, 2017·JCI Insight·Srilatha SwamiJoy Y Wu
Aug 29, 2018·International Journal of Endocrinology·Yanmei Yang, Bin Wang
Sep 29, 2015·Annals of Internal Medicine·Tarig ElraiyahMohammad Hassan Murad

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Journal of the Massachusetts Dental Society
Heather M Abourjaily, Morton Rosenberg
Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen
Joerg J MeerpohlHolger Schünemann
© 2021 Meta ULC. All rights reserved