PMID- 31073927 OWN - NLM STAT- MEDLINE DCOM- 20190708 LR - 20231011 IS - 1179-1969 (Electronic) IS - 1170-229X (Print) IS - 1170-229X (Linking) VI - 36 IP - Suppl 1 DP - 2019 Apr TI - Recommendations for the Reporting of Harms in Manuscripts on Clinical Trials Assessing Osteoarthritis Drugs: A Consensus Statement from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). PG - 145-159 LID - 10.1007/s40266-019-00667-8 [doi] AB - BACKGROUND: There is strong evidence of under-reporting of harms in manuscripts on randomized controlled trials (RCTs) compared with the volume of raw data retrieved from these trials. Many guidelines have been developed to tackle this, but they have failed to address some important issues that would allow for standardization and transparency. As a consequence, harms reporting in manuscripts remains suboptimal. OBJECTIVE: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) aimed to deliver accurate recommendations for better reporting of harms in clinical trials manuscripts on anti-osteoarthritis (OA) drugs. These could help to better inform clinicians on harms recorded in RCTs and further help researchers conducting meta-analyses. METHODS: Using the outcomes of several systematic reviews on the safety of anti-OA drugs, we summarized the ways in which harms have been reported in OA RCT manuscripts to date. Next, we drafted some recommendations and initiated a modified Delphi process that involved a panel of clinicians and clinical researchers to build an expert consensus on recommendations from the ESCEO for the reporting of harms in future manuscripts on RCTs assessing anti-OA drugs. RESULTS: These recommendations emphasize that all treatment-emergent adverse events (AEs) should always be taken into account for harms reporting, with no frequency threshold, and describe how specific AEs should be reported; they also provide a list of the most relevant organ systems to be considered according to each class of drug for reporting of harms within the results section of a manuscript. Irrespective of the drug, the ESCEO recommends that total, severe and serious AEs and withdrawals due to AEs should always be reported; guidance on the reporting of specific events pertaining to each category is provided. The ESCEO also recommends the reporting of information on drug effect on biological parameters, with specific guidance. CONCLUSIONS: These recommendations may contribute to improve transparency in the field of safety of anti-OA medications. Pharmaceutical companies developing drugs for OA, and researchers conducting clinical trials, are encouraged to comply with them when reporting harms-related results in manuscripts on RCTs. The ESCEO also encourages journals to refer to the ESCEO recommendations in their instructions to authors for the publication of manuscripts on trials of anti-OA medications. FAU - Honvo, Germain AU - Honvo G AUID- ORCID: 0000-0002-6992-6712 AD - Department of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium. germain.honvo@uliege.be. AD - WHO Collaborating Centre for Public Heath Aspects of Musculoskeletal Health and Aging, Liege, Belgium. germain.honvo@uliege.be. FAU - Bannuru, Raveendhara R AU - Bannuru RR AD - Division of Rheumatology, Allergy and Immunology, Center for Treatment Comparison and Integrative Analysis, Tufts Medical Center, Boston, MA, USA. FAU - Bruyere, Olivier AU - Bruyere O AD - Department of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium. AD - WHO Collaborating Centre for Public Heath Aspects of Musculoskeletal Health and Aging, Liege, Belgium. FAU - Rannou, Francois AU - Rannou F AD - Division of Physical Medicine and Rehabilitation, Department of Rheumatology, AP-HP Cochin Hospital, INSERM U1124, Universite Paris Descartes Sorbonne Paris Cite, Paris, France. FAU - Herrero-Beaumont, Gabriel AU - Herrero-Beaumont G AD - Bone and Joint Research Unit, Department of Rheumatology, Fundacion Jimenez Diaz, Universidad Autonoma, Madrid, Spain. FAU - Uebelhart, Daniel AU - Uebelhart D AD - Division of Musculoskeletal, Internal Medicine and Oncological Rehabilitation, Department of Orthopaedics and Traumatology, Hopital du Valais (HVS), Centre Hospitalier du Valais Romand (CHVR), CVP, Crans-Montana, Switzerland. FAU - Cooper, Cyrus AU - Cooper C AD - WHO Collaborating Centre for Public Heath Aspects of Musculoskeletal Health and Aging, Liege, Belgium. AD - MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK. AD - Musculoskeletal Biomedical Research Unit, National Institute for Health Research (NIHR), University of Oxford, Oxford, UK. FAU - Arden, Nigel AU - Arden N AD - Musculoskeletal Biomedical Research Unit, National Institute for Health Research (NIHR), University of Oxford, Oxford, UK. AD - Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis, University of Oxford, Oxford, UK. FAU - Conaghan, Philip G AU - Conaghan PG AD - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK. FAU - Reginster, Jean-Yves AU - Reginster JY AD - Department of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium. AD - WHO Collaborating Centre for Public Heath Aspects of Musculoskeletal Health and Aging, Liege, Belgium. AD - Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia. FAU - Thomas, Thierry AU - Thomas T AD - Department of Rheumatology, Hopital Nord, CHU de St-Etienne and INSERM 1059, Universite de Lyon, Saint-Etienne, France. FAU - McAlindon, Tim AU - McAlindon T AD - Division of Rheumatology, Tufts Medical Center, Boston, MA, USA. LA - eng GR - MC_U147585819/MRC_/Medical Research Council/United Kingdom GR - MC_UP_A620_1014/MRC_/Medical Research Council/United Kingdom GR - MC_UU_12011/1/MRC_/Medical Research Council/United Kingdom GR - G0400491/MRC_/Medical Research Council/United Kingdom GR - MC_U147585824/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Drugs Aging JT - Drugs & aging JID - 9102074 RN - 0 (Analgesics) SB - IM MH - Adverse Drug Reaction Reporting Systems/*standards MH - Analgesics/*adverse effects/analysis/therapeutic use MH - Consensus MH - Drug-Related Side Effects and Adverse Reactions/*prevention & control MH - Europe MH - Guidelines as Topic MH - Humans MH - Osteoarthritis/*drug therapy/economics MH - Osteoporosis/*drug therapy/economics MH - Outcome Assessment, Health Care MH - Randomized Controlled Trials as Topic/*standards MH - Societies, Medical PMC - PMC6509216 COIS- O Bruyere reports grants from Biophytis, IBSA, MEDA, Servier, SMB, and Theramex, outside of the submitted work. C. Cooper reports personal fees from Alliance for Better Bone Health, Amgen, Eli Lilly, GSK, Medtronic, Merck, Novartis, Pfizer, Roche, Servier, Takeda, and UCB, outside of the submitted work. J-Y. Reginster reports grants from IBSA-Genevrier, Mylan, CNIEL, Radius Health (through institution), consulting fees from IBSA-Genevrier, Mylan, CNIEL, Radius Health, and Pierre Fabre; fees for participation in review activities from IBSA-Genevrier, MYLAN, CNIEL, Radius Health, and Teva; payment for lectures from AgNovos, CERIN, CNIEL, Dairy Research Council (DRC), Echolight, IBSA-Genevrier, Mylan, Pfizer Consumer Health, Teva, and Theramex, outside of the submitted work. N. Arden reports personal fees from Bioventus, Flexion, Merck, Pfizer/Lilly, Regeneron, Smith & Nephew, and Freshfields Bruckhaus Deringer and grants from Bioiberica and Merck, outside the submitted work. P.G. Conaghan reports consultancy or speakers' bureaus fees from Abbvie, BMS, Flexion Therapeutics, GlaxoSmithKline, Merck Serono, Novartis, Pfizer, Roche, and Samumed outside of the submitted work. F. Rannou reports grants from APHP, INSERM, University Paris Descartes, and Arthritis (Road Network) and consulting fees from Pierre Fabre, Expanscience, Thuasne, Servier, Genevrier, Sanofi Aventis, and Genzyme, outside of the submitted work. T. McAlindon reports fees for participation in review activities from Pfizer and fees for consulting activities from Flexion, Samumed, Sanofi, Visgo, Roche, Astellas, Pfizer, Seikayaku, Regeneron, and Anika, outside of the submitted work. T. Thomas reports personal fees from Abbvie, Amgen, Arrow, BMS, Chugai, Expanscience, Gilead, HAC-Pharma, LCA, Lilly, Medac, MSD, Pfizer, Thuasne, TEVA, and UCB and grants from Amgen, Bone Therapeutics, Chugai, HAC-Pharma, MSD, Novartis, Pfizer, and UCB, outside of the submitted work. R. Bannuru was supported by the National Center for Complementary and Integrative Health (K23AT009374) and reports honorarium from Sanofi, Bioventus, and Fidia, outside of the submitted work. G. Honvo, G. Herrero-Beaumont, and D. Uebelhart have no conflicts of interest that are directly relevant to the content of this article. The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. EDAT- 2019/05/11 06:00 MHDA- 2019/07/10 06:00 PMCR- 2019/05/09 CRDT- 2019/05/11 06:00 PHST- 2019/05/11 06:00 [entrez] PHST- 2019/05/11 06:00 [pubmed] PHST- 2019/07/10 06:00 [medline] PHST- 2019/05/09 00:00 [pmc-release] AID - 10.1007/s40266-019-00667-8 [pii] AID - 667 [pii] AID - 10.1007/s40266-019-00667-8 [doi] PST - ppublish SO - Drugs Aging. 2019 Apr;36(Suppl 1):145-159. doi: 10.1007/s40266-019-00667-8.