Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours

Lancet
T P ShakespeareJ Simes

Abstract

The process of interpreting the results of clinical studies and translating them into clinical practice is being debated. Here we examine the role of p values and confidence intervals in clinical decision-making, and draw attention to confusion in their interpretation. To improve result reporting, we propose the use of confidence levels and plotting of clinical significance curves and risk-benefit contours. These curves and contours provide degrees of probability of both the potential benefit of treatment and the detriment due to toxicity. Additionally, they provide clinicians with a mechanism of translating the results of studies into treatment for individual patients, thus improving the clinical decision-making process. We illustrate the application of these curves and contours by reference to published studies. Confidence levels, clinical significance curves, and risk-benefit contours can be easily calculated with a hand calculator or standard statistical packages. We advocate their incorporation into the published results of clinical studies.

References

Feb 1, 1992·British Journal of Obstetrics and Gynaecology·D G Altman, M J Gardner
Jun 1, 1990·Statistics in Medicine·S J Pocock, M D Hughes
Feb 28, 1987·Lancet·C J Bulpitt
Mar 22, 1986·British Medical Journal·M J GardnerM J Campbell
Feb 1, 1988·Annals of Internal Medicine·L E Braitman
Sep 1, 1986·Annals of Internal Medicine·R Simon
Sep 1, 1994·Health Economics·B A van HoutF F Rutten
Jul 1, 1995·Health Economics·D L Sackett, W M Rosenberg
Jan 23, 1997·The New England Journal of Medicine·UNKNOWN International Committee of Medical Journal Editors
Apr 29, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·M Al-SarrafJ F Ensley
Oct 9, 1998·Journal of Epidemiology and Community Health·P R BurtonM J Campbell
Jun 26, 1999·Annals of Internal Medicine·S N Goodman
Sep 3, 1999·BMJ : British Medical Journal·A H Briggs, A M Gray

❮ Previous
Next ❯

Citations

Apr 9, 2010·European Journal of Applied Physiology·Keith TolfreyAlan M Batterham
Nov 19, 2008·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·Javier Escrig Sos, David Martínez Ramos
May 27, 2009·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Eric W WangJ Gail Neely
Jun 4, 2010·Journal of Sports Sciences·Simon P RobertsDylan Thompson
Sep 8, 2010·Clinical Journal of Sport Medicine : Official Journal of the Canadian Academy of Sport Medicine·David W CreightonGordon O Matheson
Sep 8, 2010·Clinical Journal of Sport Medicine : Official Journal of the Canadian Academy of Sport Medicine·Ian ShrierGordon O Matheson
Nov 27, 2008·Journal of Medical Imaging and Radiation Oncology·J I TangM F Back
Jun 15, 2005·Ophthalmic & Physiological Optics : the Journal of the British College of Ophthalmic Opticians (Optometrists)·J JorgeM A Parafita
Jan 13, 2011·BMJ : British Medical Journal·Sven TrellePeter Jüni
Nov 21, 2012·BMC Medical Research Methodology·Milo A PuhanCynthia M Boyd
Jan 12, 2012·BMC Medical Research Methodology·Alejandro Lazo-LangnerDouglas A Coyle
Feb 25, 2006·Journal of Cancer Education : the Official Journal of the American Association for Cancer Education·Thomas P ShakespeareMichael F Back
Jul 31, 2004·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Mohit Bhandari
Feb 1, 2014·Medicina clínica·Emilio Jesús Alegre Del ReyFrancisco Sierra García
Dec 29, 2011·Evidence-based Complementary and Alternative Medicine : ECAM·Lee-Fang EikVikineswary Sabaratnam
Jan 5, 2011·Medicine and Science in Sports and Exercise·Alan M BatterhamSaul G Myerson
Apr 6, 2011·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Christophe PerruchoudEric Buchser
May 3, 2007·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Jinn-Yuh GuhLea-Yea Chuang
Jan 5, 2006·Biometrical Journal. Biometrische Zeitschrift·Ralf BenderHajo Zeeb
Mar 14, 2016·Sports Medicine·Will G Hopkins, Alan M Batterham
May 5, 2010·Journal of Evaluation in Clinical Practice·Caroline Smith, Karen Grimmer-Somers
Jun 25, 2005·Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research·Philip R O PayneDavid Dowdy
May 26, 2004·Critical Reviews in Oncology/hematology·G H Lyman, N M Kuderer
Aug 20, 2015·Acta Neuropathologica Communications·Christian P MiermeisterRolf Buslei
Dec 2, 2006·The Journal of Evidence-based Dental Practice·Manal A Awad
Apr 24, 2010·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Jeff J GuoDennis W Raisch
Jul 20, 2013·Neuropsychological Rehabilitation·Mieke Heyvaert, Patrick Onghena
Aug 18, 2016·Journal of Medical Imaging and Radiation Oncology·Thomas P ShakespeareNoel J Aherne
Aug 28, 2009·Expert Opinion on Drug Safety·J BoadaE Fernandez
Jun 17, 2006·Medical Informatics and the Internet in Medicine·Thomas P ShakespeareJiade Jay Lu
Dec 23, 2016·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Pei Ni DingChee Khoon Lee
Apr 21, 2010·Clinical Child Psychology and Psychiatry·Nicola KennairPeter Brann
Dec 18, 2007·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Thomas Philip ShakespeareGuoliang Jiang
Jun 24, 2016·Autism : the International Journal of Research and Practice·Nola J ChambersRichard R Grinker
Jan 22, 2003·The Cochrane Database of Systematic Reviews·Y HeB Djulbegovic

❮ 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

BMC Medical Research Methodology
Michele L Shaffer, Kristi L Watterberg
Pharmacoepidemiology and Drug Safety
William L HoldenWanju Dai
Medical Decision Making : an International Journal of the Society for Medical Decision Making
Thomas Philip ShakespeareGuoliang Jiang
Pharmacoepidemiology and Drug Safety
William L HoldenWanju Dai
Deutsche medizinische Wochenschrift
R Bender, S Lange
© 2021 Meta ULC. All rights reserved