Unmet medical needs for chronic spontaneous urticaria patients: highlighting the real-life clinical practice in Taiwan

2015 ◽  
Vol 30 (1) ◽  
pp. 41-49 ◽  
Author(s):  
Y.-T. Cho ◽  
Y.-C. Pao ◽  
C.-Y. Chu
2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
James Burton ◽  
Sebastian Walpen ◽  
Sandrine Danel ◽  
Lucy Snowdon ◽  
Bernd Schroeppel

Abstract Background and Aims Chronic kidney disease-associated pruritus (CKD-aP) is a common yet under-recognised condition in patients with CKD undergoing haemodialysis (HD), in whom it is associated with reduced health-related quality of life (HRQoL), poor sleep quality, and a greater risk of depression. This real-world study obtained insights from nephrologists in Europe and Australia into the current practices, attitudes and unmet medical needs relating to the diagnosis and treatment of CKD-aP. Method Qualitative data were obtained from structured interviews conducted Oct–Nov 2019 with 72 nephrologists from France, Germany, Italy, Spain, UK and Australia (n=12 in each country). Quantitative data relating to diagnostic/treatment practices for CKD-aP were collected May–July 2020 by a 20-minute physician survey and collection of patient record forms (PRF). The survey was completed by 301 nephrologists from France (n=50), Germany (n=56), Italy (n=58), Spain (n=55), UK (n=52), and Australia (n=30). Respondents’ level of agreement was assessed using a 7-point scale, from 1 (do not agree at all) to 7 (strongly agree). PRF data were also captured for 1435 HD patients with CKD-aP from all countries. All nephrologists who completed the interviews and surveys were currently treating >5 HD patients with CKD-aP. Results Most nephrologists (75%) agreed that CKD-aP is under-diagnosed in HD patients, which is mainly driven by the lack of systematic screening by nephrologists and under-reporting of the condition by patients. The main barriers to screening for CKD-aP identified by nephrologists included the lack of diagnostic guidelines and absence of standardised pruritus intensity scales to consistently diagnose and classify CKD-aP severity. The majority (74%) agreed new clinical guidelines for nephrologists are needed to aid diagnosis. Nephrologists perceived that on average ∼34% of their HD patients experienced CKD-aP, and that 55% of them had moderate-severe symptoms. However, most nephrologists (79%) do not use any itch scales in clinical practice and 71% agreed a consistent international scale to diagnose CKD-aP is needed. 80% of nephrologists agreed diagnosis of CKD-aP is usually patient-driven, indicating there is a reliance on patients mentioning their symptoms. Less than half of nephrologists (46%) agreed that CKD-aP was easy to diagnose by clinical observation alone. The lack of targeted treatment guidelines and approved therapies for CKD-aP leads to an inconsistent, fragmented approach to management. Analysis of prescription data captured in the PRFs of 1435 HD patients with CKD-aP showed treatment in current clinical practice relies on incremental add-on therapy. The majority of patients (∼85-90%) receiving second- or subsequent lines of therapy for CKD-aP were prescribed combinations of different treatments. Commonly prescribed (off-label) medications for CKD-aP included antihistamines, moisturizers/emollients, corticosteroids and gabapentinoids. However, there was no single standard of care for the treatment of CKD-aP, highlighting the uncertainties nephrologists face relating to best treatment practice. Most nephrologists (72%) agreed that treatment options are very limited for patients with bothersome CKD-aP, and the survey responses indicated a high unmet need for novel treatments. The majority of nephrologists felt a major improvement was needed over current treatments, particularly in terms of improved efficacy for reduction of itch intensity (62%) and the ability to improve the patient HRQoL (57%). Conclusion This real-world international survey study of nephrologists showed that CKD-aP is a frequent, but under-diagnosed condition affecting many HD patients, with a lack of effective treatment options. Furthermore, there is an urgent need to develop guidelines to assist in the diagnosis of CKD-aP and new targeted treatment options that are both effective and well tolerated.


2021 ◽  
Author(s):  
Gabriel Hawthorne ◽  
Adam Harvey

AbstractPoint-of-care assays offer a decentralised and fast solution to the diagnosis of SARS-CoV-2 and provide benefits for patients, healthcare workers, healthcare facilities and other environments. This technology has to potential to prevent outbreaks, enable faster adoption of life-changing measures and improve hospitalar workflow. While reviews regarding the performance of those assays exist, a review focused on the real-life clinical performance and point-of-care feasibility of those platforms was missing. Therefore, the objective of this study is to help end users (clinicians, healthcare providers and organisations) to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities, or inside hospitals. 871 studies were screened in 3 major databases and 51 studies were included, evaluating 20 antigen tests and 10 nucleic-acid amplification platforms. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs in our inclusion criteria. We also investigated package inserts, instructions for use, comments on published studies and manufacturers websites in order to assess feasibility of POC placement and additional information of relevance to the end user. Apart from sensitivity and specificity, we present information on time to results, hands-on time, kit storage, machine operating conditions and regulatory status. To the best of our knowledge, this is the first review to systematically evaluate POC test performance in real-life clinical practice. We found the performance of tests in clinical practice to be markedly different from the manufacturers reported performance and laboratory-only evaluations in the majority of studies. Our findings may help in the decision-making process related to SARS-CoV-2 test in real-life clinical settings.Rationale for the reviewA review focused on the real-life clinical performance and point-of-care feasibility of SARS-CoV-2 diagnostic platforms was missing, impairing the ability of individuals, healthcare providers and test providers to make informed decisions on the adoption of such platforms.Objective(s) or question(s) the review addressesThe objective of this study is to help clinicians, healthcare providers and organisations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities or in complex hospitalar environments.


2021 ◽  
Vol 53 ◽  
pp. S529-S530
Author(s):  
G. Mattingly ◽  
H. Ren ◽  
M. Cronquist Christensen ◽  
K. Simonsen ◽  
L. Hammer-Helmich

2020 ◽  
Vol 45 (8) ◽  
pp. 1003-1010
Author(s):  
S. Savic ◽  
L. Leeman ◽  
T. El‐Shanawany ◽  
R. Ellis ◽  
J.E. Gach ◽  
...  

2019 ◽  
Vol Volume 13 ◽  
pp. 3181-3186 ◽  
Author(s):  
Laura Vollono ◽  
Arianna Piccolo ◽  
Caterina Lanna ◽  
Maria Esposito ◽  
Mauro Bavetta ◽  
...  

2016 ◽  
Vol 27 ◽  
pp. ii45 ◽  
Author(s):  
T. Buchler ◽  
Z. Bortlicek ◽  
K. Hejduk ◽  
B. Melichar ◽  
P. Pokorna ◽  
...  
Keyword(s):  

2016 ◽  
Vol 84 (1-2) ◽  
Author(s):  
Enrico Natale ◽  
Alfiera Marsocci

<p>Generally in the clinical practice patients are more complex in comparison with those included in the clinical trials. In this article, we discuss three relevant items, which may implement the transferability of the clinical trial results in the real world. The observational studies have fewer restrictions on the number of patients included, due to more relaxed inclusion and exlusion criteria than in randomized clinical trials. The absence of randomization however may lead to potential for bias. The recurrent event analysis may extend the positive results of clinical trials regarding the reductions of the first primary endpoint event to total events, including those beyond the first event. This analysis is of great interest in the clinical practice, where recurrent events are common. Finally the reliability of subgroup analysis is discussed. Pre-specified subgroup analyses are more credible and valuable than <em>post-hoc</em> analyses.</p><p><strong>Riassunto</strong></p><p>Nella pratica clinica i pazienti sono generalmente più complessi rispetto alle popolazioni studiate nei trial clinici. Si rendono necessari pertanto strumenti di analisi che integrino i trial clinici. In questo articolo vengono esaminati alcuni punti di rilevante importanza nella definizione di una corretta applicabilità dei risultati dei trial clinici al mondo reale. Il primo punto riguarda il ruolo e i limiti degli studi osservazionali. Il secondo tratta delle analisi degli eventi ricorrenti, una modalità di analisi dei trial clinici che rende i risultati più aderenti alla vita reale, nella consapevolezza che limitare i dati di outcome al primo evento sia riduttivo rispetto alla necessità di stabilire che l’intervento studiato nel trial confermi la sua efficacia anche sugli eventi successivi al primo. Il terzo punto riguarda la controversa questione delle analisi per sottogruppi, uno strumento utile per generare ipotesi, ma discutibile quando impiegato per rimediare a trial con risultati negativi o estendere i risultati di trial positivi a sottopopolazioni particolari di pazienti. </p>


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