Clinical outcome assessment in clinical trials of chronic pain treatments, 2021, Turk et al

Patel KV, Amtmann D, Jensen MP, Smith SM, Veasley C, Turk DC. Clinical outcome assessment in clinical trials of chronic pain treatments. Pain Rep. 2021 Jan 21;6(1):e784. doi: 10.1097/PR9.0000000000000784. PMID: 33521482; PMCID: PMC7837993.


Abstract

Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and are critical for determining whether a treatment is effective.

The objectives of this study are to (1) describe the different types of COAs and provide an overview of key considerations for evaluating COAs, (2) review COAs and other outcome measures for chronic pain treatments that are recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) or other expert groups, and (3) review advances in understanding pain-related COAs that are relevant to clinical trials.

The authors reviewed relevant articles, chapters, and guidance documents from the European Medicines Agency and U.S. Food and Drug Administration. Since the original core set of outcome measures were recommended by IMMPACT 14 years ago, several new advancements and publications relevant to the measurement or interpretation of COAs for chronic pain trials have emerged, presenting new research opportunities.

Despite progress in the quality of measurement of several outcome domains for clinical trials of chronic pain, there remain some measurement challenges that require further methodological investigation.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837993/

Open Access

 

This paper I think is interesting with regard to the discrepancy in the research on useful outcome measures for pain compared to the research on outcome measures for fatigue or even PEM.

Does not actually tackle the subjective-endpoints-alone-in-unblined-trials issue but discusses advantages and disadvantages of different types of outcome measures, and also shortcomings in reporting of adverse events.

Also has a paragraph on accelerometers.