Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

被引：290

作者：

Edwards, Robert R. ^{[1
]}

Dworkin, Robert H. ^{[2
]}

Turk, Dennis C. ^{[3
]}

Angst, Martin S. ^{[4
]}

Dionne, Raymond ^{[5
]}

Freeman, Roy ^{[1
]}

Hansson, Per ^{[6
,7
]}

Haroutounian, Simon ^{[8
]}

Arendt-Nielsen, Lars ^{[9
]}

Attal, Nadine ^{[10
,11
,12
]}

Baron, Ralf ^{[13
]}

Brell, Joanna ^{[14
]}

Bujanover, Shay ^{[15
]}

Burke, Laurie B. ^{[16
,17
]}

Carr, Daniel ^{[18
]}

Chappell, Amy S. ^{[19
]}

Cowan, Penney ^{[20
]}

Etropolski, Mila ^{[21
]}

Fillingim, Roger B. ^{[22
]}

Gewandter, Jennifer S. ^{[2
]}

Katz, Nathaniel P. ^{[18
,23
]}

Kopecky, Ernest A. ^{[24
]}

Markman, John D. ^{[2
]}

Nomikos, George ^{[25
]}

Porter, Linda ^{[26
]}

Rappaport, Bob A.

Rice, Andrew S. C. ^{[27
]}

Scavone, Joseph M. ^{[28
]}

Scholz, Joachim ^{[29
]}

Simon, Lee S. ^{[30
]}

Smith, Shannon M. ^{[2
]}

Tobias, Jeffrey ^{[31
]}

Tockarshewsky, Tina ^{[32
]}

Veasley, Christine ^{[33
]}

Versavel, Mark ^{[34
]}

Wasan, Ajay D. ^{[35
]}

Wen, Warren ^{[36
]}

Yarnitsky, David ^{[37
,38
]}

机构：

[1] Harvard Med Sch, Boston, MA USA

[2] Univ Rochester, Rochester, NY USA

[3] Univ Washington, Seattle, WA 98195 USA

[4] Stanford Univ, Palo Alto, CA 94304 USA

[5] East Carolina Univ, Greenville, NC USA

[6] Oslo Univ Hosp, Oslo, Norway

[7] Karolinska Inst, Stockholm, Sweden

[8] Washington Univ, St Louis, MO USA

[9] Aalborg Univ, Aalborg, Denmark

[10] Hop Ambroise Pare, APHP, Boulogne, France

[11] INSERM U987, Boulogne, France

[12] Univ Versailles St Quentin, Versailles, France

[13] Univ Kiel, Kiel, Germany

[14] MetroHlth Med Ctr, Cleveland, OH USA

[15] Depomed, Newark, CA USA

[16] LORA Grp LLC, Royal Oak, MD USA

[17] Univ Maryland, Baltimore, MD 21201 USA

[18] Tufts Univ, Boston, MA 02111 USA

[19] Eli Lilly, Indianapolis, IN USA

[20] Amer Chron Pain Assoc, Rocklin, CA USA

[21] Johnson & Johnson, Titusville, NJ USA

[22] Univ Florida, Gainesville, FL USA

[23] Analges Solut, Natick, MA USA

[24] Collegium Pharmaceut Inc, Canton, MA USA

[25] Astellas Pharma, Northbrook, IL USA

[26] NIH, Bldg 10, Bethesda, MD 20892 USA

[27] Imperial Coll, London, England

[28] Pfizer Inc, Groton, CT 06340 USA

[29] Columbia Univ, New York, NY USA

[30] SDG LLC, Cambridge, MA USA

[31] Jazz Pharmaceut, Palo Alto, CA USA

[32] Ceres Consulting, Ft Montgomery, NY USA

[33] Chron Pain Res Alliance, North Kingstown, RI USA

[34] Zalicus, Cambridge, MA USA

[35] Univ Pittsburgh, Pittsburgh, PA USA

[36] Purdue Pharma, Stamford, CT USA

[37] Rambam Hlth Care Campus, Haifa, Israel

[38] Technion Israel Inst Technol, Fac Med, Haifa, Israel

来源：

PAIN | 2016年 / 157卷 / 09期

关键词：

Phenotype; Central pain modulation; Neuropathic; Quantitative sensory testing; Psychosocial; Sleep; LOW-BACK-PAIN; TAPENTADOL PROLONGED RELEASE; INTRAVENOUS KETAMINE TEST; ORAL DEXTROMETHORPHAN TREATMENT; EXERCISE-INDUCED HYPOALGESIA; PSYCHOLOGICAL RISK-FACTORS; CHRONIC POSTOPERATIVE PAIN; PREDICTIVE RESPONSE TOOL; SPINAL-CORD STIMULATION; GERMAN RESEARCH NETWORK;

D O I：

10.1097/j.pain.0000000000000602

中图分类号：

R614 [麻醉学];

学科分类号：

100217 [麻醉学];

摘要：

There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for "precision medicine" or personalized pain therapeutics (ie, empirically based algorithms that determine the optimal treatments, or treatment combinations, for individual patients) that would presumably improve both the clinical care of patients with pain and the success rates for putative analgesic drugs in phase 2 and 3 clinical trials. However, before implementing this approach, the characteristics of individual patients or subgroups of patients that increase or decrease the response to a specific treatment need to be identified. The challenge is to identify the measurable phenotypic characteristics of patients that are most predictive of individual variation in analgesic treatment outcomes, and the measurement tools that are best suited to evaluate these characteristics. In this article, we present evidence on the most promising of these phenotypic characteristics for use in future research, including psychosocial factors, symptom characteristics, sleep patterns, responses to noxious stimulation, endogenous pain-modulatory processes, and response to pharmacologic challenge. We provide evidence-based recommendations for core phenotyping domains and recommend measures of each domain.

引用

页码：1851 / 1871

页数：21

共 273 条

[1]

[Anonymous], 2012, From acute to chronic back pain: risk factors, mechanisms, and clinical implications

[2]

An Investigation of Factors Contributing to Higher Levels of Placebo Response in Clinical Trials in Neuropathic Pain: A Systematic Review and Meta-Analysis [J].