Dennis C. Turk

The concepts of sex and gender are often incorrectly used in health research. Sex is a biological construct while gender is a social construct, but both may have differential effects on the outcome of pain treatments. To better understand how chronic pain trials collect, report, and analyze data regarding sex and gender we conducted a targeted systematic review of randomized clinical trials of pharmacological and non-pharmacological treatments for various chronic pain conditions. Across 6 pain specialty journals, 2,883 abstracts from papers published 2016-2021 were screened, and 73 manuscripts ultimately reviewed for reporting and analysis of sex and gender. All 73 studies collected information on sex, yet only 16 papers (21.9%) reported how they collected this information (e.g., self-report, medical record review). No studies collected information on gender, and 30 papers (41.1%) used the terms sex and gender …

Large variability in the individual response to even the most-efficacious pain treatments is observed clinically, which has led to calls for a more personalized, tailored approach to treating patients with pain (ie, “precision pain medicine”). Precision pain medicine, currently an aspirational goal, would consist of empirically based algorithms that determine the optimal treatments, or treatment combinations, for specific patients (ie, targeting the right treatment, in the right dose, to the right patient, at the right time). Answering this question of “what works for whom” will certainly improve the clinical care of patients with pain. It may also support the success of novel drug development in pain, making it easier to identify novel treatments that work for certain patients and more accurately identify the magnitude of the treatment effect for those subgroups. Significant preliminary work has been done in this area, and analgesic trials …

The decades since the inauguration of the International Association for the Study of Pain have witnessed major advances in scientific concepts (such as the biopsychosocial model and chronic primary pain as a disease in its own right) and in new technologies and approaches (from molecular biology to brain imaging) that have inspired innovations in pain research. These have guided progress in pain management and education about pain for healthcare professionals, the general public, and administrative agencies.

The management of patients with chronic pain is one of the most important issues In medicine and public health. Chronic pain conditions cause substantial suffering for patients, their significant others and society over years and even decades and increases healthcare utilization resources including the cost of medical care, loss of productivity and provision of disability services. Primary care providers are at the frontline in the identification and management of patients with chronic pain, as the majority of patients enter the healthcare system through primary care and are managed by primary care providers. Due to the complexity of chronic pain and the range of issues involved, the accurate diagnosis of the causes of pain and the formulation of effective treatment plans presents significant challenges in the primary care setting. In this review, we use the classification of pain types based on pathophysiology as the …

ImportanceNovel treatments for opioid use disorder (OUD) are needed to address both the ongoing opioid epidemic and long-standing barriers to existing OUD treatments that target the endogenous μ-opioid receptor (MOR) system. The goal of this review is to highlight unique clinical trial design considerations for the study of emerging treatments for OUD that address targets beyond the MOR system. In November 2019, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration sponsored a meeting to discuss the current evidence regarding potential treatments for OUD, including cannabinoids, psychedelics, sedative-hypnotics, and immunotherapeutics, such as vaccines.ObservationsConsensus recommendations are presented regarding the most critical elements of trial design for …

Science and medicine have a long and troubling history of reinforcing racist, antiethnic, and sexist attitudes and beliefs, as well as ignoring and mistreating marginalized people. In their editorial in Nature, 1 titled “Science Must Overcome Its Racist Legacy,” Nobles and colleagues described how the scientific enterprise has reinforced racist beliefs and cultures over time. For example, the authors discussed the impact of colonization on racism, including how apartheid, imperialism, colonialism, slavery, and eugenics were memorably endorsed by science. They then asserted that acknowledging and learning this history is necessary if we are to restore, rebuild, and avoid perpetuating these injustices. Similarly, there is a long history of exclusion of women from science and medicine as a profession due to structural discrimination as well as exclusion of women from research participation in clinical trials to develop …

Objectives: To better understand the relationships among treatment, pain, and physical function (PF).Methods: Data were collected from 2 published randomized clinical trials of osteoarthritis patients who received tanezumab or a placebo. PF was measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) PF domain. Pain (WOMAC pain domain) was a mediator of the effect of treatment on PF. A set of mediation models were investigated. Variables were treatment (tanezumab vs placebo), WOMAC pain domain, and WOMAC PF domain. Cross-sectional mediation models were assessed separately at different weeks. Longitudinal mediation models used data from all weeks simultaneously. Results could identify a steady-state period.Results: The cross-sectional and longitudinal mediation models showed a stable indirect effect of treatment through the pain on PF across time, indicating …

Self-reported pain intensity, frequently used as an outcome in randomized clinical trials (RCTs) of chronic pain, is often highly variable and could be associated with multiple baseline factors. Thus, the assay sensitivity of pain trials (ie, the ability of the trial to detect a true treatment effect) could be improved by including prespecified baseline factors in the primary statistical model. The objective of this focus article was to characterize the baseline factors included in statistical analyses of chronic pain RCTs. Seventy-three RCTs published between 2016 and 2021 that investigated interventions for chronic pain were included. The majority of trials identified a single primary analysis (72.6%; n = 53). Of these, 60.4% (n = 32) included one or more covariates in the primary statistical model, most commonly baseline value of the primary outcome, study site, sex, and age. Only one of the trials reported information regarding …