Clinical outcome assessment in clinical trials of chronic pain treatments
نویسندگان
چکیده
Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and critical for determining whether a treatment is effective. The objectives of this study (1) describe the different types COAs provide an overview key considerations evaluating COAs, (2) review other measures chronic pain treatments recommended by Initiative on Methods, Measurement, Pain Assessment Trials (IMMPACT) or expert groups, (3) advances understanding pain-related relevant trials. authors reviewed articles, chapters, guidance documents from European Medicines Agency U.S. Food Drug Administration. Since original core set were IMMPACT 14 years ago, several new advancements publications measurement interpretation have emerged, presenting research opportunities. Despite progress quality domains pain, there remain some challenges require further methodological investigation.
منابع مشابه
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.
Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4) Disruption of the P2X(7) purinoceptor gene abolishes chronic inflammatory and neuropathic pain
متن کاملCore outcome domains for chronic pain clinical trials: IMMPACT recommendations.
OBJECTIVE To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research propos...
متن کاملThe outcome of control groups in clinical trials of conservative treatments for chronic mechanical neck pain: a systematic review
BACKGROUND Chronic neck pain is highly prevalent in Western societies, with about 15% of females and 10% of males suffering with it at any time. The course of untreated chronic neck pain patients in clinical trials has not been well-defined and the placebo effect has not been clarified. METHODS A systematic review of RCT's of conservative treatments for chronic mechanical neck pain was conduc...
متن کاملIdentifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain.
This two-phase study was conducted to identify relevant domains of patient-reported outcomes from the perspective of people who experience chronic pain. In Phase 1, focus groups were conducted to generate a pool of patient outcome-related domains and their components. The results of the focus groups identified 19 aspects of their lives that were significantly impacted by the presence of their s...
متن کاملEvaluation of Clinical Trials
In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Pain reports
سال: 2021
ISSN: ['2471-2531']
DOI: https://doi.org/10.1097/pr9.0000000000000784