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A previously developed educational e-health tool considers both clinical and psychosocial factors when selecting patients with chronic pain for spinal cord stimulation (SCS). The validity of the composite recommendations was evaluated in a retrospective study, demonstrating a strong relationship with patient outcomes after SCS.
Learn More >Psoriasis poses a substantial economic burden by reducing the work productivity of affected patients. We aimed to evaluate the negative impact of plaque psoriasis on work productivity and effectiveness of brodalumab in improving work productivity impairment in real-life employed patients. This analysis was conducted in employed patients from ProLOGUE, an open-label, multicenter, prospective cohort study (Japan Registry of Clinical Trials identifier: jRCTs031180037). Outcomes included association of Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) domain scores with scores from various patient-reported outcome measures or Psoriasis Area and Severity Index (PASI) scores at baseline. Change from baseline in WPAI-PSO domain scores following brodalumab treatment was also evaluated. Of the 73 patients enrolled, 51, 48, and 40 patients were considered employed at baseline, Week 12, and Week 48 of brodalumab treatment, respectively. In the model adjusted by age and sex, the work productivity loss score correlated with the Dermatology Life Quality Index (DLQI), itch Numeric Rating Scale (NRS), Patient Health Questionnaire-8 (PHQ-8), and skin pain NRS scores (partial Spearman correlation coefficient [ρ] = 0.608, 0.510, 0.461, and 0.424, respectively); presenteeism score correlated with the DLQI, itch NRS, and skin pain NRS scores (ρ = 0.568, 0.500, and 0.403, respectively); and activity impairment score correlated with the DLQI and PHQ-8 scores (ρ = 0.530 and 0.414, respectively). None of the WPAI-PSO domain scores correlated with the PASI score. All WPAI-PSO domain scores (except absenteeism) significantly reduced from baseline to Weeks 12 (p < 0.0001) and 48 (p < 0.001) with brodalumab treatment. In conclusion, work productivity impairment in psoriasis was associated with various subjective symptoms that can be captured using patient-reported outcome measures. Brodalumab treatment improved work productivity in real-life employed patients with plaque psoriasis.
Learn More >Migraine is a disease characterized by cerebral vasodilation. While diabetes has previously been associated with a lower risk of migraine, it is not known if diabetic retinopathy (DR), a retinal peripheral vascular occlusive disease, is a potential biomarker of protection against migraine. Therefore, we aimed to examine diabetic retinopathy as a marker of prevalent and 5-year incident migraine. In a national cohort, we compared patients with diabetes attending DR screening from The Danish National Registry of Diabetic Retinopathy (cases, n = 205,970) to an age- and gender-matched group of patients without diabetes (controls, n = 1,003,170). In the cross-sectional study, a multivariable model demonstrated a lower prevalence of migraine among cases compared with controls (OR 0.83, 95% CI 0.81-0.85), with a lower risk in cases with DR than in those without (OR 0.69, 95% CI 0.65-0.72). In the prospective study, a lower risk of incident migraine was found in a multivariable model in cases (HR 0.76, 95% CI 0.70-0.82), but this did not depend upon the presence of DR. To conclude, in a national study of more than 1.2 million people, patients screened for DR had a lower risk of present migraine, but DR was not a protective marker of incident migraine.
Learn More >Osteoarthritis (OA) and chronic low back pain (CLBP) are common musculoskeletal disorders with substantial patient and societal burden. Nordic administrative registers offer a unique opportunity to study the impact of these conditions in the real-world setting. The Burden of Disease and Management of Osteoarthritis and Chronic Low Back Pain: Health Care Utilization and Sick Leave in Sweden, Norway, Finland and Denmark (BISCUITS) study was designed to study disease prevalence and the societal and economic burden in broad OA and CLBP populations.
Learn More >Capsaicin, an agonist at the transient receptor potential vanilloid 1, is used for the topical treatment of peripheral neuropathic pain. Reversible receptor defunctionalization and degeneration and subsequent regeneration of cutaneous nociceptors are discussed as its mechanism of action. Here, we hypothesize an accelerated functional recovery of a sub-class of nociceptive afferents, the peptidergic vasoactive nociceptors, as the potential cause of capsaicin analgesia.In this non-interventional exploratory trial, 23 patients with peripheral neuropathic pain were treated with one topical high-concentration capsaicin application. Baseline pain ratings, co-morbidities and quality-of-life were assessed. Functional laser-speckle-contrast-analysis (fLASCA, heat-evoked neurogenic vasodilatation to assess functional properties of peptidergic nociceptors) and quantitative sensory testing (QST) were performed in the affected skin. Four weeks after treatment fLASCA and questionnaires were repeated. Telephone interviews were conducted at week 2, 10 and 12.Topical capsaicin treatment induced a significant reduction of pain intensity with a maximum at four weeks. At the same time, heat-evoked neurogenic vasodilatation was on average similar to pre-treatment values. Half of the patients not only showed a functional recovery but also an improvement of vasodilatation, indicating regeneration of nerve fibers. Patients with improved heat-evoked neurogenic vasodilatation at week 4 showed a greater pain reduction than patients with deterioration. The degree of vasodilatation significantly correlated with pain reduction.These findings suggest that (i) regeneration of peptidergic nociceptors may be one mechanism of capsaicin-induced analgesia and (ii) that a disease-modifying effect of capsaicin on these fibers already occurs four weeks after application.
Learn More >Atopic dermatitis (AD) is a chronic skin disease that significantly impacts patient quality of life (QoL). It is unknown whether patients and physicians have the same interpretation of AD burden. Unmet needs and AD disease burden were evaluated by comparing terminology used in social media with terminology used in scientific literature. AD terminology in social media was identified using the NetBase platform, and natural language processing was performed. Topics and words driving negative sentiment were evaluated overall and in relation to specific symptoms. The systematic review of scientific literature identified publications that included AD and QoL terms was identified from PubMed. Term analysis of titles and abstracts was conducted via natural language processing. The occurrence of topics and co-occurrence of words associated with QoL terms were evaluated. More than 3 million social media mentions (2018-2020) and 1519 scientific publications (2000-2020) were evaluated. There were more negative than positive social media mentions, and flare and pain were common symptoms driving negative sentiment. Face and hands were major drivers of negative sentiment in relation to AD symptoms in social media. Sleep and pain were often mentioned together. In scientific literature, pruritus and depression were the most frequently occurring symptoms. Similarly, pruritus was the most common AD symptom co-occurring with QoL terms in the assessed scientific literature. Social media analyses provide a unique view into the patient experience of AD. Symptoms driving negative sentiment in social media appear to be discordantly represented in scientific literature. Incorporating patient perspectives may improve disease understanding and management.
Learn More >The efficacy and safety of tralokinumab, a fully human monoclonal antibody that specifically neutralizes interleukin-13, plus topical corticosteroids (TCS) as needed were evaluated over 32 weeks in the phase III ECZTRA 3 trial. Significantly more tralokinumab- versus placebo-treated patients achieved the primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and 75% improvement in Eczema Area and Severity Index (EASI-75) and all confirmatory endpoints at Week 16.
Learn More >White matter hyperintensities (WMHs) are frequently found in migraineurs. However, their clinical significance and correlation to different migraine phenotypes and treatment responses are not well defined. The study aimed to examine the association of WMHs with migraine clinical patterns and treatment response.
Learn More >This study examines how onset of chronic pain affects characteristics of personal social networks among adults aged 51+ across Europe.
Learn More >Initial content validation and roadmap for a new patient-reported outcome measure of pain intensity.
Measures of pain intensity (e.g., numeric rating scales [NRS]) are widely used in clinical research and practice. While these measures have evidence for validity and reliability, poor standardization of instructions and response options limits precision of pain assessment, allows for inconsistency in interpretation, and presents a challenge for comparison and aggregation of study results. Despite these pitfalls, the 0-to-10 NRS remains the most commonly used primary outcome measure in clinical trials of pain treatments and is the core measure recommended by regulatory agencies. The purpose of this study was to describe the first phase in the development of a pain intensity measure that is easily interpretable, psychometrically sound, and that adheres to FDA qualification processes. The Analgesic, Anesthetic, and Addiction Clinical Trial, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership conducted concept elicitation interviews (N=44; 22 with acute pain; 22 with chronic pain) to understand the patient perspective on rating pain intensity and to identify actionable suggestions for improved clarity and meaningfulness of instructions, recall periods, and response options. This article summarizes interview findings, describes how patient input and FDA feedback informed preliminary candidate measures, and provides an overview of the FDA qualification process. PERSPECTIVE: Concept elicitation interviews informed the development of content-valid candidate measures of acute and chronic pain intensity for planned use in clinical trials of pain treatments, and comprise the initial stage in FDA clinical outcome assessment qualification. Measures will subsequently be evaluated through cognitive interviews and a series of psychometric studies.
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