scholarly journals Psychometric Validation and Responder Definition of Sleep Disturbance Numerical Rating Scale in Moderate‐To‐Severe Atopic Dermatitis

Author(s):  
J. Puelles ◽  
F. Fofana ◽  
D. Rodriguez ◽  
J.I. Silverberg ◽  
A. Wollenberg ◽  
...  
Author(s):  
Carla Dias-Barbosa ◽  
Rodolfo Matos ◽  
Margaret Vernon ◽  
Colleen E. Carney ◽  
Andrew Krystal ◽  
...  

Abstract Background The intense itching associated with atopic dermatitis (AD) often causes patients to experience severe sleep disturbance. Here, we describe the results of a two-phase concept elicitation and cognitive interview study to establish the content validity of a sleep disturbance numerical rating scale (SD NRS) and a Consensus Sleep Diary adapted for adults and adolescents with moderate-to-severe AD (CSD-AD©). Results In phase I, a concept elicitation conducted in 20 adults and 10 adolescents with moderate-to-severe AD revealed that the following sleep-related issues were important and relevant: nighttime awakening (87%), trouble falling asleep (73%), feeling unrested (53%), daytime fatigue or sleepiness (53%), and feeling as if they did not get enough sleep (33%). The frequency and extent of sleep disturbance varied substantially from day to day due to varying degrees of itching and flares, medication use, and changes in the weather. All participants understood the SD NRS question, with most finding it easy or very easy to understand (100% of adults and 90% of adolescents) and most understanding the anchors as intended (95% of adults, and 100% of adolescents). Most participants (94% of adults, and 90% of adolescents) indicated that they would consider a one- or two-point change meaningful on the SD NRS. The CSD-AD© was revised based on participant feedback, and tested during phase II in a convenience sample of six adults and four adolescents from phase I. The changes made to the CSD-AD© were confirmed to be relevant and understandable. All patients were able to provide an answer to each item in the CSD-AD©, and most were able to estimate the duration of nighttime awakenings, daytime naps, and dozing. Conclusions The study supported the content validity of the SD NRS and CSD-AD© in adults and adolescents with moderate-to-severe AD. It also emphasized the importance of using these instruments daily when assessing the benefit of a new treatment on sleep quality in this population.


2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Carla Dias-Barbosa ◽  
Rodolfo Matos ◽  
Margaret Vernon ◽  
Colleen E. Carney ◽  
Andrew Krystal ◽  
...  

An amendment to this paper has been published and can be accessed via the original article.


2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Alfonsina Casalena ◽  
Ilaria Frattale ◽  
Valeria Caponnetto ◽  
Amleto Gabriele ◽  
...  

Abstract BackgroundMost patients treated with erenumab in clinical practice have chronic migraine (CM). We assessed the rate and possible predictors of conversion from CM to episodic migraine (EM) in a real-life study.Main bodyWe performed a subgroup analysis of patients treated with erenumab from January 2019 to February 2020 in the Abruzzo region, central Italy. Treatment was provided according to current clinical practice. For the purpose of the present study, we included patients fulfilling the definition of CM for the three months preceding erenumab treatment and with at least 6 months of follow-up after treatment. We assessed the rate of conversion to EM from baseline to Months 4–6 of treatment and during each month of treatment. To test the clinical validity of conversion to EM, we also assessed the decrease in monthly headache days (MHDs), acute medication days, and median headache intensity on a Numerical Rating Scale (NRS). We included in our study 91 patients with CM. At Months 4–6, 62 patients (68.1%) converted from CM to EM; the proportion of converters increased from Month 1 to Month 5. In the overall group of patients, median MHDs decreased from 26.5 (IQR 20–30) to 7.5 (IQR 5–16; P < 0.001) compared with baseline, while median acute medication days decreased from 21 (IQR 16–30) to 6 (IQR 3–10; P < 0.001) and median NRS scores decreased from 8 (IQR 7–9) to 6 (IQR 4–7; P < 0.001). Significant decreases were found both in converters and in non-converters. We found no significant predictors of conversion to EM among the patients’ baseline characteristics.ConclusionsIn our study, two thirds of patients with CM converted to EM during 6 months of treatment with erenumab. MHDs, acute medication use, and headache intensity decreased regardless of conversion from CM to EM.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Dong Hyek Jang ◽  
Seok Jae Heo ◽  
Hyung Don Kook ◽  
Dong Heon Lee ◽  
Hye Jung Jung ◽  
...  

AbstractPreviously, we have reported short term effectiveness and safety of dupilumab in Korea. In this study, we are trying to report the long-term effectiveness and safety of dupilumab in Korea. Ninety-nine patients with moderate to severe AD were analyzed. They were evaluated using Eczema Area and Severity Index (EASI), Numerical Rating Scale (NRS), Patient Oriented Eczema Measure (POEM), and Dermatology Quality of Life Index (DLQI) at baseline, week 16, 32 and 52. Efficacy outcomes showed higher improvement at 52 weeks compared with 16 weeks; high percentual reductions in EASI (88.1%), peak pruritus NRS (65.6%), POEM (67.2%), and DLQI (69.0%) compared to baseline. Proportion of patients achieving EASI 75 and 90 were 90.2% and 53.7%. POEM and DLQI had high correlation with clinical measured outcomes. In the analysis for the factors affecting achievement of EASI 90, female gender (OR 2.5), eosinophilia (OR 0.2) and elevated LDH (OR 0.07) were significantly associated. Most frequent adverse events included facial erythema (19.2%) and conjunctivitis (17.2%), which were mild/moderate and resolved during treatment. In conclusion, dupilumab treatment for 52 weeks in Korean patients with moderate-to-severe AD confirmed long term effectiveness and safety.


2020 ◽  
Vol 4 (3) ◽  
pp. 279
Author(s):  
Matthew T Reynolds ◽  
Scott M Dinehart ◽  
Katlyn R Anderson ◽  
Joe Gorelick

Objectives: Prurigo nodularis (PN) is a disease of aberrant and recalcitrant itching which is difficult to effectively manage. There are no current FDA-approved therapies for PN.  The current topical and systemic medications used for this condition provide less than optimal efficacy for the majority of patients with this condition and often have unacceptable side effects.  We report 4 patients who were effectively treated with dupilumab (Dupixent) for the treatment of recalcitrant PN.Methods:  Four patients were treated successfully with dupilumab, a systemic biologic agent that is not immunosuppressive (Dupixent; Sanofi-Regeneron). Patients were treated with dupilumab monotherapy, without the use of other systemic immunosuppressing agents. The peak pruritus numerical rating scale (NRSi) was used to evaluate patients at weeks 0 and 4. Results: Dupilumab therapy results in a dramatic reduction in NRSi scores by week 4 and that result continues throughout the duration of therapy. This reduction in itch is seen with continuous therapy.Conclusion: Dupilumab therapy appears effective in reducing the overall itch severity in patients with PN. The usage of dupilumab as a monotherapy shows promise in the treatment of PN. The therapeutic response to dupilumab seen in PN suggests that the pathogenesis of PN may overlap with that of atopic dermatitis. 


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19500-19500
Author(s):  
A. F. Dugas ◽  
B. A. Murphy ◽  
N. Wells ◽  
M. S. Dietrich ◽  
K. Dwyer

19500 Background: This study investigates: 1) The concordance between patients and staffs’ standard use of the numerical rating scale (NRS) for pain, in which 1–4 is mild pain, 5–6 is moderate and 7 and above is severe; 2) The relative importance of functional impairment secondary to pain in patients’ pain ratings. Methods: Patients with cancer and current or previous pain (N=178) were asked to complete a fifteen minute interview with open-ended questions about their perception of pain. Results: When asked to define mild, moderate and severe pain according to the NRS, 65% of patients gave numbers that did not meet standard definitions as noted above. When asked to define mild, moderate and severe pain in general, 38% differentiated severity of pain based on its impact on their ability to fulfill activities of daily living (ADLs) and 39% differentiated it based on their emotional reactions. When asked to define tolerable pain, 28% described it in terms of its impact on ADLs, while 30% described it in terms of the NRS. For those patients who used a NRS, the mean value for tolerable pain was 4.9 (range 2–8) and the mean value for intolerable pain was 8.1 (range 5–10). 26% of patients defined satisfactory pain control based its impact on ADLs while only 2% defined it according to a NRS. 68% of patients reported that pain interfered with their ADLs, however only 33% reported that pain medication interfered. Conclusions: There is discordance between the standard definition of the NRS and patient perceptions of it, suggesting it should be supplemented by other types of pain assessment. Based on NRS, patients tolerate higher levels of pain than expected. Patient satisfaction with pain control is more dependent upon ability to complete ADLs than on a numerical rating of pain. Therefore, patients’ ability to function at an acceptable level should be part of the standard pain assessment. No significant financial relationships to disclose.


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