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Drugs Aging. 2019 Apr;36(Suppl 1):145-159. doi: 10.1007/s40266-019-00667-8.

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).

Author information

1
Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium. germain.honvo@uliege.be.
2
WHO Collaborating Centre for Public Heath Aspects of Musculoskeletal Health and Aging, Liège, Belgium. germain.honvo@uliege.be.
3
Division of Rheumatology, Allergy and Immunology, Center for Treatment Comparison and Integrative Analysis, Tufts Medical Center, Boston, MA, USA.
4
Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium.
5
WHO Collaborating Centre for Public Heath Aspects of Musculoskeletal Health and Aging, Liège, Belgium.
6
Division of Physical Medicine and Rehabilitation, Department of Rheumatology, AP-HP Cochin Hospital, INSERM U1124, Université Paris Descartes Sorbonne Paris Cité, Paris, France.
7
Bone and Joint Research Unit, Department of Rheumatology, Fundación Jiménez Diaz, Universidad Autonoma, Madrid, Spain.
8
Division of Musculoskeletal, Internal Medicine and Oncological Rehabilitation, Department of Orthopaedics and Traumatology, Hôpital du Valais (HVS), Centre Hospitalier du Valais Romand (CHVR), CVP, Crans-Montana, Switzerland.
9
MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
10
Musculoskeletal Biomedical Research Unit, National Institute for Health Research (NIHR), University of Oxford, Oxford, UK.
11
Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis, University of Oxford, Oxford, UK.
12
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
13
Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia.
14
Department of Rheumatology, Hôpital Nord, CHU de St-Etienne and INSERM 1059, Université de Lyon, Saint-Étienne, France.
15
Division of Rheumatology, Tufts Medical Center, Boston, MA, USA.

Abstract

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.

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