Related Experiment Video
Updated: May 18, 2026

Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery
Published on: April 14, 2016
Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: an ACTTION
Shannon M Smith1, Daniel R Chang, Anthony Pereira
1Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Queen's University, Kingston, ON, Canada Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA United States Food and Drug Administration, Bethesda, MA, USA Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA California Pacific Medical Center Research Institute, San Francisco, CA, USA CHDI, New York, NY, USA Departments of Anesthesiology and Neurology and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Abstract:
Recommendations for harms (ie, adverse events) reporting in randomized clinical trial publications were presented in a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement. Our objectives were to assess harms reporting in 3 major pain journals (European Journal of Pain, Journal of Pain, and PAIN®) to determine whether harms reporting improved following publication of the 2004 CONSORT recommendations, and to examine study factors associated with adequacy of harms reporting. A total of 101 randomized, double-blind, noninvasive pharmacologic trials were identified in the 2000-2003 (epoch 1) and 2008-2011 (epoch 2) issues of these journals. Out of 10 reporting recommendations, the mean number fulfilled was 6.08 (SD2.65). Although more harms recommendations were fulfilled in epoch 2 (m(2)=6.49, SD2.66) than in epoch 1 (m(1)=5.39, SD2.52; P=0.04), only the recommendation to report harms per arm was satisfied by >90% of trials in epoch 2, whereas <60% reported withdrawals due to harms. Several trial characteristics (study design, participant type, pain type, frequency of treatment administration, treatment administration method, sponsor, and number of randomized participants) were significantly associated with harms reporting. However, when trial characteristics and epoch were entered into a multiple regression analysis, only trials studying pain patients, those using oral treatments, and industry-sponsored trials were associated with better harms reporting. Despite some improvement in harms reporting, greater improvement is needed to provide informative, consistent reporting of adverse events and safety in analgesic clinical trials.
Related Concept Videos
Types of Reports III: Telephone and Verbal Reports
Here's an overview of each type:
Telephone Orders
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Analgesia and Pain Management
SBAR II: Application of SBAR
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
Introduction to Documentation and Reporting
Nursing documentation records essential information and details regarding a patient's care and treatment in written or electronic form. It is a critical aspect of nursing practice that involves documenting assessments, interventions, outcomes, and other relevant details about a patient's health status.
Documentation maps the patient's health journey by creating a comprehensive and precise...
Targets for Drug Action: Overview
Receptors are either membrane-spanning or intracellular proteins, which upon binding a ligand, get activated and transmit the signal downstream to elicit a response. Drugs bind receptors, either mimicking the action of endogenous ligands or blocking the receptor activity to bring about a modified response. Nearly 35% of approved drugs target the G...