Although improving, 'harms reporting' in analgesic clinical trials is generally poor. On average the 101 studied analgesic trials met only 60% of harms reporting recommendations.

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• Shannon M Smith, R Daniel Chang, Anthony Pereira, Nirupa Shah, Ian Gilron, Nathaniel P Katz, Allison H Lin, Michael P McDermott, Bob A Rappaport, Michael C Rowbotham, Cristina Sampaio, Dennis C Turk, and Robert H Dworkin.
• Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. shannon1_smith@urmc.rochester.edu
• Pain. 2012 Dec 1;153(12):2415-21.

AbstractRecommendations 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.Copyright © 2012 International Association for the Study of Pain. All rights reserved.

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