scholarly journals Conversion From Chronic to Episodic Migraine in Patients Treated With Erenumab: Real-life Data From an Italian Region

2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Alfonsina Casalena ◽  
Ilaria Frattale ◽  
Valeria Caponnetto ◽  
Amleto Gabriele ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Central Italy ◽  
Real Life ◽  
Episodic Migraine ◽  
Headache Intensity ◽  
Acute Medication ◽  
Numerical Rating ◽  
Definition Of

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.

scholarly journals Conversion From Chronic To Episodic Migraine In Patients Treated With Erenumab: Real-Life Data From An Italian Region

2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Alfonsina Casalena ◽  
Ilaria Frattale ◽  
Valeria Caponnetto ◽  
Amleto Gabriele ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Central Italy ◽  
Real Life ◽  
Episodic Migraine ◽  
Main Body ◽  
Life Study ◽  
Headache Intensity ◽  
Acute Medication

Abstract Background. Most 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 body. We 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.Conclusions. In 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.

Acupuncture for Insomnia in Pregnancy – a Prospective, Quasi-Randomised, Controlled Study

2005 ◽  
Vol 23 (2) ◽  
pp. 47-51 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pregnant Women ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Randomised Controlled Study ◽  
Numerical Rating ◽  
Randomised Controlled

Objective This study was undertaken to test the effects of acupuncture on insomnia in a group of pregnant women under real life conditions, and to compare the results with a group of patients undergoing conventional treatment alone (sleep hygiene). Methods A total of 30 conventionally treated pregnant women were allocated at random into groups with or without acupuncture. Seventeen patients formed the study group and 13 the control group. The pregnant women scored the severity of insomnia using a Numerical Rating Scale from 0 to 10. Women were followed up for eight weeks and interviewed five times, at two-week intervals. Results Eight women dropped out, five in the study group and three in the control group. The study group reported a larger reduction on insomnia rating (5.1) than the control group (0.0), a difference which was statistically significant (P=0.0028). Average insomnia scores decreased by at least 50% over time in nine (75%) patients in the study group and in three (30%) of the control group. Conclusion The results of this study suggest that acupuncture alleviates insomnia during pregnancy and further research is justified.

scholarly journals Assessing Pain Intensity in Children with Chronic Pain: Convergent and Discriminant Validity of The 0 To 10 Numerical Rating Scale in Clinical Practice

2014 ◽  
Vol 19 (3) ◽  
pp. 141-148 ◽  
Author(s):  
Danielle Ruskin ◽  
Chitra Lalloo ◽  
Khushnuma Amaria ◽  
Jennifer N Stinson ◽  
Erika Kewley ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Clinical Practice ◽  
Pain Intensity ◽  
Discriminant Validity ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Pain Clinic ◽  
Small Range ◽  
Convergent And Discriminant Validity ◽  
Numerical Rating

BACKGROUND: In clinical practice, children are often asked to rate their pain intensity on a simple 0 to 10 numerical rating scale (NRS). Although the NRS is a well-established measure for adults, no study has yet evaluated its validity for children with chronic pain.OBJECTIVES: To examine the convergent and discriminant validity of the NRS as it is used within regular clinical practice to document pain intensity for children with chronic pain. Interchangeability between the NRS and an analogue pain measure was also assessed.METHODS: A cohort of 143 children (mean [± SD] age 14.1±2.4 years; 72% female) rated their pain intensity (current, usual, lowest and strongest levels) on a verbally administered 0 to 10 NRS during their first appointment at a specialized pain clinic. In a separate session that occurred either immediately before or after their appointment, children also rated their pain using the validated 0 to 10 coloured analogue scale (CAS).RESULTS: NRS ratings met a priori criteria for convergent validity (r>0.3 to 0.5), correlating with CAS ratings at all four pain levels (r=0.58 to 0.68; all P<0.001). NRS for usual pain intensity differed significantly from an affective pain rating, as hypothesized (Z=2.84; P=0.005), demonstrating discriminant validity. The absolute differences between NRS and CAS pain scores were small (range 0.98±1.4 to 1.75±1.9); however, the two scales were not interchangeable.CONCLUSIONS: The present study provides preliminary evidence that the NRS is a valid measure for assessing pain intensity in children with chronic pain.

Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study

2020 ◽  
Vol 91 (9) ◽  
pp. 914-920
Author(s):  
Clara Grazia Chisari ◽  
Claudio Solaro ◽  
Pasquale Annunziata ◽  
Roberto Bergamaschi ◽  
Assunta Bianco ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Large Population ◽  
Real Life ◽  
Discontinuation Rate ◽  
Real Life Data ◽  
Numerical Rating ◽  
Therapy Option

IntroductionDelta-δ-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were to provide real-life data on long-term clinical outcomes in a large population of Italian patients treated with THC:CBD and to evaluate predictors of THC:CBD therapy continuation.Materials and methodsThis prospective observational multicentre Italian study screened all patients with MS consecutively included in the Agenzia Italiana del Farmaco e-registry at the start of THC:CBD treatment (baseline), after 4 weeks (T1), 12±3 weeks (T2), 24±3 weeks (T3), 48±3 weeks (T4) and 72±3 weeks (T5) from baseline.ResultsA total of 1845 patients were recruited from 32 MS Italian centres. At T1, 1502 (81.4%) of patients reached a Numerical Rating Scale (NRS) improvement of ≥20%, with an NRS reduction of 26.9% at T1 and of 34.4% at T5. At T5, 725 patients (48.3% of 1502) discontinued treatment with highest discontinuation rate at T2 and T3. Daily number of puffs was generally stable through the observation period. The multivariate analysis showed that higher NRS scores at baseline (OR 2.28, 95% CI 1.15 to 6.36, p<0.01) and higher differences of NRS between T0 and T1 (OR 2.11, 95% CI 1.08 to 8.26, p<0.05) were associated with an increased probability to continue therapy after 18 months.DiscussionTHC:CBD effects were sustained for 18 months with a relatively stable number of puffs per day. About 50% of patients abandoned THC:CBD therapy for loss of efficacy or adverse events.

scholarly journals Fremanezumab in the Prevention of High-Frequency Episodic and Chronic Migraine: A 12-Week, Multicenter, Real-Life, Cohort Study (The FRIEND Study).

2021 ◽  
Author(s):  
Piero Barbanti ◽  
Gabriella Egeo ◽  
Cinzia Aurilia ◽  
Florindo d'Onofrio ◽  
Maria Albanese ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
High Frequency ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Drug Effects ◽  
Episodic Migraine ◽  
Primary Study ◽  
Life Study ◽  
Younger Age

Abstract Background Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8-14 days/month) or CM. Methods This is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9-12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥50%, ≥75% and 100% responder rates at the same time intervals. Results 67 migraine patients had received ≥1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p<0.05), MHDs (-9.4, p<0.001), MAI (-5.7, p<0.05; -11.1, p<0.001), NRS (-3.1, p<0.001; -2.5, p<0.001), and MIDAS scores (-58.3, p<0.05; -43.7; p<0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p<0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥50%, ≥75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR=0.91; 95% CI 0.85-0.98, p=0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason. Conclusions Fremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor.

scholarly journals Evaluation of the effectiveness of intra-articular administration of highly purified hyaluronic acid in knee osteoarthritis in real clinical practice

2021 ◽  
Vol 15 (5) ◽  
pp. 57-61
Author(s):  
V. A. Nesterenko ◽  
E. I. Byalik ◽  
M. A. Makarov ◽  
S. A. Makarov ◽  
V. E. Byalik ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Clinical Practice ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Knee Oa ◽  
Numerical Rating ◽  
Pain At Rest ◽  
Favorable Safety ◽  
Real Clinical Practice

Knee osteoarthritis (kOA) is a common cause of turning for medical advice, associated with chronic pain and disability. One of the methods of OA treatment is the local administration of hyaluronic acid (HA) drugs.Objective: to evaluate the effectiveness of intra-articular (IA) administration of highly purified HA (Armaviskon Plus) in kOA.Patients and methods. The study group consisted of 58 patients (74.1% women and 25.9% men, aged 59.5±11.8 years) with kOA, experiencing moderate/severe pain (≥40 mm on a visual analogue scale, VAS). All patients received IA injection of HA Armaviskon Plus (2 ml of a 1.5% solution), 2 injections with an interval of 7 days. The effectiveness criterion was the dynamics of pain at rest and during movement (VAS 0-100 mm) and the function of the knee joint according to a numerical rating scale (NRS 0-100 points) 2 weeks, 1 and 3 months after administration of therapy.Results and discussion. During the treatment, there was a significant improvement in all indicators. The average severity of pain during movement at baseline, after 2 weeks, 1 and 3 months was 50 [40; 60], 30 [20; 40], 15 [0; 30], 20 [0; 30] mm (p<0.001), at rest 20 [10; 40], 5 [0; 20], 0 [0; 20], 10 [0; 20] mm (p<0.05) by VAS. The average values of functional indicators were 40 [10; 60], 10 [0; 40], 20 [0; 40], 10 [10; 30] scores according to the NRS. A decrease in non-steroidal anti-inflammatory drugs demand was recorded: 67.1% of patients were initially taking them, after 3 months – 36.1% (p<0.001). No serious adverse reactions were noted.Conclusion. IA administration of HA is an effective and safe method for the treatment of kOA. Armaviskon Plus, a highly purified high-molecular- weight HA drug, has shown good results in pain reduction and improvement of function in knee OA as well as a favorable safety profile, which makes it possible to recommend its use in real clinical practice.

scholarly journals Multicenter survey on emergency nurses’ perception of Numerical Rating Scale reliability at triage time in adult Emergency Department patients

2018 ◽  
Vol 14 (3) ◽  
Author(s):  
Gianfranco Cervellin ◽  
Ivan Comelli ◽  
Andrea Bellone ◽  
Fabrizio Giostra ◽  
Nicoletta Acierno ◽  
...  
Keyword(s):  
Pain Measurement ◽  
Pain Perception ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Central Italy ◽  
Reliability And Validity ◽  
Emergency Nurses ◽  
Multicenter Survey ◽  
Numerical Rating ◽  
Triage Time

Since pain perception is highly subjective and culturally mediated, its objective evaluation remains difficult. Nevertheless, pain measurement should ideally be a part of the assessment of patients in order to plan adequate pain relief. Several scales have been proposed for pain measurement, being the numerical rating scale (NRS) the most widely used, often at triage time. NRS have demonstrated acceptable reliability and validity, in post-operative medicine and in oncologic pain, but data in the Emergency Departments (EDs) are poor. The aim of this study is to evaluate the Emergency Nurses’ (ENs) perception about the reliability of NRS in the triage process. A questionnaire based on 11 items was designed and subsequently administered to a large number of ENs in several EDs in Northern and Central Italy. 301 questionnaires were filled out and returned. The majority declares using NRS scale to measure pain (item 2, mode = 4, mean = 3.8), and attributing priority code based on NRS value (item 3, mode = 4, mean = 3.4). In general, triage nurses believe that NRS is only indicative and that their judgement matters (item 4, mode = 4, mean = 3.2). The vast majority of triage nurses do believe that the patients will indicate a fake higher NRS value with the aim to get a more urgent code (item 5, mode = 5, mean = 4), while only a small minority expects that patients would underestimate their NRS for fear of penalizing more urgent patients. Very few believe that such scale underestimates the patients’ condition, while the majority is ambivalent about whether such scale overestimates it. In conclusion, NRS confirms to be a potentially valuable tool for pain evaluation at triage time, but many nurses express some doubts on its reliability, and will attribute the triage code mainly basing on their own judgement.

Acupuncture for Dyspepsia in Pregnancy: A Prospective, Randomised, Controlled Study

2009 ◽  
Vol 27 (2) ◽  
pp. 50-53 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay ◽  
Rassen Saidah
Keyword(s):  
Conventional Treatment ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Controlled Study ◽  
Control Group ◽  
Life Conditions ◽  
Randomised Controlled Study ◽  
Numerical Rating ◽  
Randomised Controlled

Objectives This study was undertaken to describe under real-life conditions the effects of acupuncture on symptomatic dyspepsia during pregnancy and to compare this with a group of patients undergoing conventional treatment alone. Methods A total of 42 conventionally treated pregnant women were allocated by chance into two groups to be treated, or not, by acupuncture. They reported the severity of symptoms and the disability these were causing in daily aspects of life such as sleeping and eating, using a numerical rating scale. The study also observed the use of medications. Results Six women dropped out (one in the acupuncture group and five in the control group). Significant improvements in symptoms were found in the study group. This group also used less medication and had a greater improvement in their disabilities when compared with the control group. Conclusions This study suggests that acupuncture may alleviate dyspepsia during pregnancy.

Assessment of cancer pain

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19500-19500
Author(s):  
A. F. Dugas ◽  
B. A. Murphy ◽  
N. Wells ◽  
M. S. Dietrich ◽  
K. Dwyer
Keyword(s):  
Pain Assessment ◽  
Pain Control ◽  
Severe Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Mean Value ◽  
Emotional Reactions ◽  
Numerical Rating ◽  
The Mean ◽  
Definition Of

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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