Literature DB >> 24486289

Individual and composite study endpoints: separating the wheat from the chaff.

Robert Goldberg1, Joel M Gore2, Bruce Barton3, Jerry Gurwitz4.   

Abstract

We provide an overview of the individual and combined clinical endpoints and patient-reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes.
Copyright © 2014 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Clinical epidemiology; Study design; Study outcomes and endpoints

Mesh:

Year:  2014        PMID: 24486289      PMCID: PMC4019929          DOI: 10.1016/j.amjmed.2014.01.011

Source DB:  PubMed          Journal:  Am J Med        ISSN: 0002-9343            Impact factor:   4.965


  30 in total

1.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

Authors:  D Moher; K F Schulz; D G Altman
Journal:  Lancet       Date:  2001-04-14       Impact factor: 79.321

2.  Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.

Authors:  Sean R Tunis; Daniel B Stryer; Carolyn M Clancy
Journal:  JAMA       Date:  2003-09-24       Impact factor: 56.272

3.  Surrogate outcomes: meaningful not!

Authors:  D M Fisher
Journal:  Anesthesiology       Date:  1999-02       Impact factor: 7.892

4.  Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

Authors:  C Begg; M Cho; S Eastwood; R Horton; D Moher; I Olkin; R Pitkin; D Rennie; K F Schulz; D Simel; D F Stroup
Journal:  JAMA       Date:  1996-08-28       Impact factor: 56.272

5.  Approval of a tuberculosis drug based on a paradoxical surrogate measure.

Authors:  Jerry Avorn
Journal:  JAMA       Date:  2013-04-03       Impact factor: 56.272

6.  Effect of a community intervention on patient delay and emergency medical service use in acute coronary heart disease: The Rapid Early Action for Coronary Treatment (REACT) Trial.

Authors:  R V Luepker; J M Raczynski; S Osganian; R J Goldberg; J R Finnegan; J R Hedges; D C Goff; M S Eisenberg; J G Zapka; H A Feldman; D R Labarthe; P G McGovern; C E Cornell; M A Proschan; D G Simons-Morton
Journal:  JAMA       Date:  2000-07-05       Impact factor: 56.272

Review 7.  Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials.

Authors:  R Collins; S MacMahon
Journal:  Lancet       Date:  2001-02-03       Impact factor: 79.321

8.  Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint.

Authors:  Jeffrey A Bakal; Cynthia M Westerhout; Warren J Cantor; Francisco Fernández-Avilés; Robert C Welsh; David Fitchett; Shaun G Goodman; Paul W Armstrong
Journal:  Eur Heart J       Date:  2012-12-19       Impact factor: 29.983

9.  Final report on the aspirin component of the ongoing Physicians' Health Study.

Authors: 
Journal:  N Engl J Med       Date:  1989-07-20       Impact factor: 91.245

10.  Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

Authors: 
Journal:  Health Qual Life Outcomes       Date:  2006-10-11       Impact factor: 3.186

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  13 in total

1.  Composite outcomes in observational studies of Crohn's disease: a systematic review and meta-analysis.

Authors:  Fernando Magro; Catarina Sottomayor; Catarina Alves; Mafalda Santiago; Paula Ministro; Paula Lago; Luís Correia; Raquel Gonçalves; Diana Carvalho; Francisco Portela; Cláudia Camila Dias; Axel Dignass; Silvio Danese; Laurent Peyrin-Biroulet; Maria Manuela Estevinho; Paula Leão Moreira
Journal:  Therap Adv Gastroenterol       Date:  2022-05-13       Impact factor: 4.802

2.  The impact of kidney function in patients on antithrombotic therapy: a post hoc subgroup analysis focusing on recurrent bleeding events from the AFIRE trial.

Authors:  Kunihiko Matsui; Satoshi Yasuda; Koichi Kaikita; Masaharu Akao; Junya Ako; Tetsuya Matoba; Masato Nakamura; Katsumi Miyauchi; Nobuhisa Hagiwara; Kazuo Kimura; Atsushi Hirayama; Hisao Ogawa
Journal:  BMC Med       Date:  2022-02-25       Impact factor: 8.775

3.  Long-term Association of Depression Symptoms and Antidepressant Medication Use With Incident Cardiovascular Events in the Look AHEAD (Action for Health in Diabetes) Clinical Trial of Weight Loss in Type 2 Diabetes.

Authors:  Helen P Hazuda; Sarah A Gaussoin; Rena R Wing; Susan Z Yanovski; Karen C Johnson; Mace Coday; Thomas A Wadden; Edward S Horton; Brent Van Dorsten; William C Knowler
Journal:  Diabetes Care       Date:  2019-03-04       Impact factor: 19.112

4.  Consensus Report on Shigella Controlled Human Infection Model: Clinical Endpoints.

Authors:  Calman A MacLennan; Mark S Riddle; Wilbur H Chen; Kawsar R Talaat; Varsha Jain; A Louis Bourgeois; Robert Frenck; Karen Kotloff; Chad K Porter
Journal:  Clin Infect Dis       Date:  2019-12-09       Impact factor: 9.079

5.  Assessing Clinical Change in Individuals Exposed to Repetitive Head Impacts: The Repetitive Head Impact Composite Index.

Authors:  Charles Bernick; Guogen Shan; Lauren Bennett; Jay Alberts; Jeffrey Cummings
Journal:  Front Neurol       Date:  2021-07-06       Impact factor: 4.086

6.  A low cortisol response to stress is associated with musculoskeletal pain combined with increased pain sensitivity in young adults: a longitudinal cohort study.

Authors:  Markus Paananen; Peter O'Sullivan; Leon Straker; Darren Beales; Pieter Coenen; Jaro Karppinen; Craig Pennell; Anne Smith
Journal:  Arthritis Res Ther       Date:  2015-12-10       Impact factor: 5.156

7.  Win Ratio -An Intuitive and Easy-To-Interpret Composite Outcome in Medical Studies.

Authors:  Hongyue Wang; Jing Peng; Juila Z Zheng; Bokai Wang; Xiang Lu; Chongshu Chen; Xin M Tu; Changyong Feng
Journal:  Shanghai Arch Psychiatry       Date:  2017-02-25

8.  Cognitive composite score association with Alzheimer's disease plaque and tangle pathology.

Authors:  Michael Malek-Ahmadi; Kewei Chen; Sylvia E Perez; Anna He; Elliott J Mufson
Journal:  Alzheimers Res Ther       Date:  2018-09-11       Impact factor: 6.982

Review 9.  Understanding the Use of Composite Endpoints in Clinical Trials.

Authors:  C Eric McCoy
Journal:  West J Emerg Med       Date:  2018-06-04

10.  Association of Race and Major Adverse Cardiac Events (MACE): The Atherosclerosis Risk in Communities (ARIC) Cohort.

Authors:  Ericha G Franey; Donna Kritz-Silverstein; Erin L Richard; John E Alcaraz; Caroline M Nievergelt; Richard A Shaffer; Vibha Bhatnagar
Journal:  J Aging Res       Date:  2020-03-21
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