Ambroise Paré Hospital, France
Institute of Pain Medicine, Rambam Health Care Campus, Israel
Medicines and Healthcare products Regulatory Agency, UK
Professor of Pain Research Imperial College, UK
In neuropathic pain, and indeed many other areas, a general failure in efficient translation of knowledge from preclinical experiments to clinical effectiveness has compromised bringing new drugs to the clinic. The reasons for this failure are complex and multifactorial; but include, for example, shortcomings in rigour, transparency and internal and external validity in the design, conduct, analysis and dissemination of pre-clinical experiments. This generates a requirement for robust and reliable tools to appraise preclinical data in a structured and consistent manner in order to inform decisions relating to justification of clinical trials and their design.
This presentation will focus on the emerging opportunities for efficient and rigorous appraisal of pre-clinical evidence using systematic review and meta-analysis. These techniques have, over the last 4 decades, evolved to be the cornerstone of clinical medicine – informing decisions at both individual patient and policy levels. We are now at the start of an exciting new era where such methods are now deployable to appraise pre-clinical data. The speaker will discuss some of the unique challenges in conducting pre-clinical systematic review and how recent technical developments have addressed these. Using examples from his own work the speaker will describe the valuable knowledge revealed by these approaches, including risk of bias assessment and effect size estimation.
The direction of travel in clinical neuropathic pain is towards biomarker driven stratified trials and precision medicine. Time permitting, the speaker will briefly touch on the need to align animal and human biomarkers and make a case for including ethologically relevant behavioral paradigms in preclinical composite biomarkers.
University of Nottingham, UK
Imperial College Healthcare NHS Trust, UK
Harvard Medical School, USA
National Institut for Health and Medical Research (Inserm), France
Jena University Hospital, Germany
Ruth Zaslansky,1 Phlipp Baumbach,1 Winfried Meissner,1 and the PAIN OUT collaborative
Dept. of Anaesthesiology and Intensive Care, University Hospital Jena, Erlanger Allee 101, D 07740 Jena, Germany.
A person’s response to pain is a complex interaction between biological, psychological and social factors. When carried out in a single country, the focus of pain studies is often on the biological and/or psychological factors. When multi-country studies are carried out, social or ‘cultural’ factors will potentially affect responses. ‘Culture’ is difficult to define and to operationalize. The effects of ‘culture’ on pain should probably not be ignored as there may be need to adapt assessment tools and/or treatments when they are applied in countries or to people who speak languages other than where they were first developed. Clinicians, researchers and regulatory authorities, should be aware about these ‘cultural’ components so they are taken into account when these stakeholders carry out their respective tasks.1,2
In the international, perioperative pain registry, PAIN OUT, we compared patient reported outcomes (PROs) from a sample of American patients after orthopedic surgery with patients’ reports from 13 countries (‘International’).3 USA patients rated some PROs higher than the ‘International’ patients, specifically ‘worst pain’; for other PROs, differences were not so apparent. This was puzzling. Were the differences in ‘worst pain’ assessments related to culture? To differences in care? Is this a methods question? Is ‘worst pain’ less sensitive to change compared to some other PROs? It is one of the most commonly used PROs in pain studies.
These preliminary findings apply to reports of acute pain in patients after orthopedic surgery. We are in the process of carrying out studies in additional patient populations and pain conditions, acute and chronic. Results will be presented and discussed during the talk.
- Sharma, S, Ferreira-Valente, A, de C. Williams, A.C., Abbott,JH , Pais-Ribeiro, J , Jensen, M.P , Group Differences Between Countries and Between Languages in Pain-Related Beliefs, Coping, and Catastrophizing in Chronic Pain: A Systematic Review, Pain Medicine, pnz373, https://doi.org/10.1093/pm/pnz373
- Feng, Y., Herdman, M., van Nooten, F. et al. An exploration of differences between Japan and two European countries in the self-reporting and valuation of pain and discomfort on the EQ-5D. Qual Life Res 26, 2067–2078 (2017). https://doi.org/10.1007/s11136-017-1541-5
- Zaslansky R, Meissner W, Chapman CR. Pain after orthopaedic surgery: differences in patient reported outcomes in the United States vs internationally. An observational study from the PAIN OUT dataset. Br J Anaesth. 2018;120(4):790-797. doi:10.1016/j.bja.2017.11.109
University Hospital Muenster, Germany
Jena University Hospital, Germany
UKSH Universitätsklinikum Schleswig-Holstein, Germany
Christian-Albrechts-Universitaet Kiel, Germany
As the SARS-Cov-2 pandemic requires special attention on its psychological effects and the impact on patients with chronic pain, we conducted a study aimed at examining the influence of the COVID-19 pandemic- associated restrictions initiated by the German government on pain intensity and characteristics, emotional well-being and everyday life of patients with painful polyneuropathy.
43 patients (well-assessed with questionnaires prior to the pandemic and without change of their health status between baseline and current assessment) were investigated with validated, standardised self-reported questionnaires two weeks after the restrictions came into effect.
Pain intensity remained stable or even improved while the Rumination scores of the Pain Catastrophizing Scale were lower during compared to before the pandemic restrictions.
Results suggest a shift of attention from the chronic pain condition towards the imminent threat of a global pandemic. As the impacts of the pandemic are persistent and evolving, the development of the measured parameters during the course of it will be of great interest.
University College London, UK
Heidelberg University, Germany