A Reevaluation of the Simplified Psoriasis Index (SPI) Using the Thai Language Version: A Study Examining the Validity, Reliability, and Interpretability of SPI When Used in Translation

2019 ◽  
Vol 5 (1) ◽  
pp. 32-39 ◽  
Author(s):  
Leena Chularojanamontri ◽  
Chanisada Wongpraparut ◽  
Waranaree Winayanuwattikun ◽  
Chris E. M. Griffiths ◽  
Robert J. G. Chalmers
Keyword(s):  
Past History ◽  
Life Quality ◽  
Severity Index ◽  
Independent Study ◽  
Severe Psoriasis ◽  
Validity And Reliability ◽  
Summary Measure ◽  
Language Version ◽  
Thai Language ◽  
Cutoff Scores

Background: The Simplified Psoriasis Index (SPI) is a summary measure of psoriasis for current severity (SPI-s), psychosocial impact (SPI-p), and past history and interventions (SPI-i). Two complementary versions are available, differing only in that current severity is either professionally (proSPI-s) or patient self-assessed (saSPI-s). They have been shown to be valid, reliable, and interpretable. Objective: The current study investigated whether the validity, reliability, and interpretability of SPI could be replicated in an independent study in a different population and setting. Methods: A validated translation of SPI into Thai was used to assess the validity and reliability of SPI for assessing psoriasis in 100 Thai patients. The interpretability of proSPI-s and saSPI-s was assessed in 289 Thai patients. Results: There were close correlations between Psoriasis Area and Severity Index (PASI) and proSPI-s ( r = 0.84) and between PASI and saSPI-s ( r = 0.78). The SPI-p was closely correlated with the validated Thai version of the Dermatology Life Quality Index ( r = 0.78). Excellent intrarater (proSPI-s, saSPI-s, SPI-p, and SPI-i) reliability was demonstrated (all ICC ≥0.88). The PASI-equivalent cutoff scores for mild (PASI < 10) and severe psoriasis (PASI ≥ 20) were <9 and ≥18 for proSPI-s and <11 and ≥20 for saSPI-s. Conclusion: Our study confirms that SPI retains good validity and reliability in translation. The cutoff points we obtained were very close to those of the original study and confirmed that the originally proposed PASI-equivalent cutoff scores for mild and severe psoriasis of <9 and ≥18 for psoSPI-s and <10 and ≥20 for saSPI-s, respectively, were valid for use in a very different language and setting.

Psoriasis: IL-17A-Inhibitor zeigt gute Langzeitwirksamkeit

2020 ◽  
Vol 8 (1) ◽  
pp. 12-13
Author(s):  
Natalia Kirsten
Keyword(s):  
Safety Profile ◽  
Human Monoclonal Antibody ◽  
Life Quality ◽  
Severity Index ◽  
Severe Psoriasis ◽  
Open Label ◽  
The Core ◽  
Favourable Safety ◽  
Trial Treatment ◽  
Double Blinded

Background: Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has been shown to have significant efficacy and a favourable safety profile in the treatment of moderate-to-severe psoriasis and psoriatic arthritis. Objective: To assess the efficacy and safety of secukinumab through 5 years of treatment in moderate-to-severe psoriasis. Methods: In the core SCULPTURE study, Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 continued receiving subcutaneous secukinumab until Year 1. Thereafter, patients entered the extension phase and continued treatment as per the core trial. Treatment was double-blinded until the end of Year 3 and open-label from Year 4. Here, we focus on the 300 mg fixed-interval (every 4 weeks) treatment, the recommended per label dose. Efficacy data are primarily reported as observed, but multiple imputation (MI) and last observation carried forward (LOCF) techniques were also undertaken as supportive analyses. Results: At Year 1, 168 patients entered the extension study and at the end of Year 5, 126 patients completed 300 mg (every 4 weeks) treatment. PASI 75/90/100 responses at Year 1 (88.9%, 68.5% and 43.8%, respectively) were sustained to Year 5 (88.5%, 66.4% and 41%). PASI responses were consistent regardless of the analysis undertaken (as observed, MI, or LOCF). The average improvement in mean PASI was approximately 90% through 5 years compared with core study baseline. DLQI (dermatology life quality index) 0/1 response also sustained through 5 years (72.7% at Year 1 and 65.5% at Year 5). The safety profile of secukinumab remained favourable, with no cumulative or unexpected safety concerns identified. Conclusion: Secukinumab 300 mg treatment delivered high and sustained levels of skin clearance and improved quality of life through 5 years in patients with moderate-to-severe psoriasis. Favourable safety established in the secukinumab phase 2/3 programme was maintained through 5 years.

scholarly journals Cost-Effectiveness Analysis of Psoriasis Treatment Modalities in Malaysia

2019 ◽  
Vol 8 (7) ◽  
pp. 394-402
Author(s):  
Nor Azmaniza Azizam ◽  
Aniza Ismail ◽  
Saperi Sulong ◽  
Norazirah Md Nor
Keyword(s):  
Cost Effectiveness ◽  
Treatment Options ◽  
Life Quality ◽  
Severity Index ◽  
Severe Psoriasis ◽  
Public Hospitals ◽  
Treatment Modalities ◽  
Psoriasis Area Severity Index ◽  
Cost Effective Treatment ◽  
The Cost

Background: There is limited evidence detailing the cost-effectiveness of psoriasis treatments in the Asian region. Therefore, this study is aimed to evaluate the cost-effectiveness of 3 psoriasis treatments tailored for moderate to severe psoriasis, namely topical and phototherapy (TP), topical and systemic (TS), and topical and biologic (TB) regimens, respectively. Methods: This has been achieved by the participation of a prospective cohort involving a total of 90 moderate to severe psoriasis patients, which has been conducted at 5 public hospitals in Malaysia. The main outcome measures have been evaluated via cost and effectiveness psoriasis area severity index (PASI)-75 and/or body surface area (BSA) <5 and/or dermatology life quality index (DLQI) ≤5), estimated from the societal perspective over a 6-months duration. All costs are based on 2015’s recorded Malaysian Ringgit (RM) currency. Results: Consequently, TS has been found to be the most cost-effective treatment with the lowest cost/PASI-75/and/or BSA <5 and/or DLQI ≤5, valued at RM9034.56 (US$2582.55). This is followed by TP, which is valued at RM28 080.71 (US$8026.93) and TB, valued at RM54 287.02 (US$15 518.06). Furthermore, one-way sensitivity analysis has highlighted the cost of medication as the most sensitive parameter. Conclusion: Thus, the input from this study is helpful for policy-makers in determining the first line treatment for moderate to severe psoriasis with consideration of the costs and its effectiveness in Malaysia. This will consequently allow hospitals to justify and provide the essential resources for further research and development, as well as the adoption of better treatment options.

scholarly journals Association of Pathogenic Th17 Cells with the Disease Severity and Its Potential Implication for Biological Treatment Selection in Psoriasis Patients

2020 ◽  
Vol 2020 ◽  
pp. 1-16
Author(s):  
Cristina Aguilar-Flores ◽  
Octavio Castro-Escamilla ◽  
Elizabeth M. Ortega-Rocha ◽  
César Maldonado-García ◽  
Fermín Jurado-Santa Cruz ◽  
...  
Keyword(s):  
Disease Severity ◽  
Peripheral Blood ◽  
Th17 Cells ◽  
Life Quality ◽  
Severity Index ◽  
Experimental Models ◽  
Cutaneous Lesions ◽  
Potential Implication ◽  
Th17 Lymphocytes ◽  
Pasi Score

Psoriasis is an inflammatory autoimmune disease characterized by cutaneous lesions in plaques. It has been proposed that the immune response has a key role in the disease progression. Particularly, the Th17 cells through IL-17 can contribute to maintain the inflammatory process. The pathogenic Th17 phenotype has been described in human diseases and associated with high severity in inflammatory experimental models. However, it is not clear if the pathogenic phenotype could be present in the skin and peripheral blood as well as its possible association to severity in psoriasis. In the lesional skin, we found high infiltration of Th17 cells and the pathogenic phenotype, finding a correlation between the frequency of Th17 cells and the Psoriasis Area and Severity Index (PASI) score. In peripheral blood, we observed a pool of Th17 lymphocytes with potential to acquire pathogenic features. Interestingly, the percentage of pathogenic Th17 cells (CD4+ RORγt+ IFN-γ+) correlates with disease severity. Moreover, we distinguished three groups of patients based on their IL-17/IFN-γ production by Th17 lymphocytes, which seems to be related with a dynamic or stable potential to express these cytokines. Remarkably, we evaluated the cytokine production by Th17 cells as an immunological marker for the adequate selection of biologic therapy. We found that patients analyzed by this immunological approach and treated with antibodies against IL-17 and TNFα showed great improvement depicted by reduction in PASI and Dermatology Life Quality Index (DLQI) score as well as the percentage of Body Surface Area (BSA). Altogether, our results highlight the importance of the assessment of the pathogenic phenotype in Th17 cells as an immune personalized analysis with the potential to support the therapy choice in the clinical practice.

Trends in Hidradenitis Suppurativa Disease Severity and Quality of Life Outcome Measures: A Systematic Review (Preprint)

2021 ◽  
Author(s):  
Jalal Maghfour ◽  
Torunn Elise Sivesind ◽  
Cory A. Dunnick ◽  
Robert Paul Dellavalle
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Disease Severity ◽  
Outcome Measures ◽  
Hidradenitis Suppurativa ◽  
Life Quality ◽  
Clinical Score ◽  
Validity And Reliability ◽  
Patient Reported

BACKGROUND While there has been an increase in the number of randomized, controlled trials (RCTs) evaluating treatment efficacy for HS, instrument measurements of disease severity and quality of life (QoL) are varied, making compilation of data and comparison between studies a challenge for clinicians. OBJECTIVE The aim of this review is to evaluate trends in disease severity scales and patient reported outcome measures used in RCTs assessing treatment interventions among HS patients. METHODS A primary systematic literature review was conducted in August 2020. PubMed/MEDLINE, Embase, Web of Science, and Cochrane databases were used to identify all articles published from January 1964 to July 2020. The study was prospectively registered with PROSPERO (ID: 209582). Twenty-five articles were included in the systematic review. RESULTS Sartorius and modified Sartorius scores (n=8), and Hidradenitis Suppurativa Clinical score (HiSCs) (n=8) were the most commonly used instruments for disease severity. Participants’ pain, followed by Dermatology Life Quality Index (DLQI), were the most common QoL measures used in the reviewed studies. CONCLUSIONS Heterogeneity of data characterizing both the validity and reliability of existing outcome measures hinders interpretation and translation of the results from RCTs into clinical practice. Many of the QoL measures identified were not specific to HS and may not be representative of all factors impacting patients.

scholarly journals Validation of the Brazilian version of the Attentional Function Index

2013 ◽  
Vol 21 (2) ◽  
pp. 604-609 ◽  
Author(s):  
Carla Klava dos Reis Dutra ◽  
Edinêis de Brito Guirardello
Keyword(s):  
Convergent Validity ◽  
Validity And Reliability ◽  
Alpha Coefficient ◽  
Index Method ◽  
Cronbach Alpha ◽  
Cronbach Alpha Coefficient ◽  
Language Version ◽  
Attentional Function ◽  
Function Index ◽  
Brazilian Version

OBJECTIVES: To assess the reliability and validity of the Brazilian version of the Attentional Function Index. METHOD: Methodological study. The sample was made up of 138 students from an undergraduate nursing course. The psychometric properties were assessed through the convergent construct validity, using the Brazilian version of the Attentional Function Index and the Portuguese-language version of the Profile of Mood States instrument, while the reliability was measured by its internal consistency, expressed by the Cronbach Alpha Coefficient. RESULTS: The Cronbach Alpha Coefficient was 0.86 for the total score, and varied from 0.64 to 0.86 in the three subscales. A strong significant negative correlation (r=-0.64; p<0.0001) was obtained for the convergent validity. CONCLUSION: The Brazilian version of the Attentional Function Index resulted in satisfactory levels of validity and reliability, demonstrating its viability for use in practice and in undertaking further research.

scholarly journals Serbian Translation and Validation of SF-36 for Assessment of Quality of Life in Patients with Diagnosed Arterial Hypertension

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Aleksandra Nikolic ◽  
Vladimir Biocanin ◽  
Nemanja Rancic ◽  
Mirjana Duspara ◽  
Dusan Djuric
Keyword(s):  
Arterial Hypertension ◽  
Test Validity ◽  
Life Quality ◽  
Special Importance ◽  
Validity And Reliability ◽  
Alpha Coefficient ◽  
Internal Reliability ◽  
Questionnaire Measure ◽  
Sf 36 ◽  
Serbian Version

Abstract Precise estimation of life quality is of special importance in patients with chronic diseases, such as arterial hypertension. There are many questionnaires for that purpose. SF 36 with 8 domains has been proved as one of the most appropriate. To date, there was no translated and validated SF 36 in the Serbian language for hypertensive patients. The aim of this study was to test validity and reliability of the SF-36 in Serbian patients with diagnosed arterial hypertension. Cronbach’s alpha coefficient was calculated to assess the internal consistency of the Serbian version of the SF-36. After deducting the overlap between each of the 36 items and its related domain, the collective validity was considered to be good if the correlation coefficient remains > 0.4. Only 2.54% answers to the questions were missing. The values of all 8 domains were higher in men than in women. Cronbach alpha coefficient was high for the SF-36, 0.897, and it suggests that the SF-36 had good internal reliability. All 8 domains showed high values of non-rotating factorial weights (>0.300) (range from 0.742-0.856), and all measure the same thing. It means that all components in this questionnaire measure the things they are assigned to.

scholarly journals PGA×BSA: A Measure of Psoriasis Severity Tested in Patients with Active Psoriatic Arthritis and Treated with Certolizumab Pegol

2018 ◽  
Vol 45 (7) ◽  
pp. 922-928 ◽  
Author(s):  
Jessica A. Walsh ◽  
Terri Arledge ◽  
Tommi Nurminen ◽  
Luke Peterson ◽  
Jeffrey Stark
Keyword(s):  
Psoriatic Arthritis ◽  
Dermatology Life Quality Index ◽  
Certolizumab Pegol ◽  
Life Quality ◽  
Severity Index ◽  
Strong Correlations ◽  
Double Blind ◽  
Percentage Improvement ◽  
High Concordance ◽  
Psoriasis Severity

Objective.The product of physician’s global assessment and body surface area (PGA×BSA) to assess psoriasis severity has previously been investigated in patients with psoriasis, with the aim of assessing PGA×BSA as an alternative to the time-consuming Psoriasis Area and Severity Index (PASI). Here, we investigate PGA×BSA as an alternative to PASI in patients with psoriatic arthritis (PsA).Methods.Analyses used data from the double-blind, placebo-controlled, RAPID-PsA trial (NCT01087788) that investigated the efficacy of certolizumab pegol (CZP) in patients with PsA. Outcomes assessed whether the PGA×BSA and PASI results were comparable, and whether these outcomes correlated with one another or with the Dermatology Life Quality Index (DLQI).Results.For CZP-treated patients, both PGA×BSA and PASI demonstrated similar sensitivities to treatment between baseline and Week 24, with mean improvements of 77.4% and 69.0%, respectively. Similar improvements were also seen with placebo (PGA×BSA: 3.2%, PASI: 6.1%). Achievement of 75% response criterion in PGA×BSA and PASI was attained by similar proportions of patients with CZP (PGA×BSA75: 59.0%, PASI75: 61.4%) and placebo (PGA × BSA75: 15.1%, PASI75: 15.1%). Cross tabulations showed high concordance between achievement of response outcomes in PGA×BSA and PASI (79.6–95.2%). Spearman correlations revealed strong correlations between PGA×BSA and PASI at baseline (r = 0.78; n = 225) and percentage improvement to Week 24 (r = 0.85; n = 186). Both outcomes were only moderately correlated with DLQI (r = 0.41–0.50; n = 179–249).Conclusion.PGA×BSA is sensitive to changes in skin manifestations in patients with PsA treated with CZP. Further, PGA×BSA correlates strongly with PASI, and achievement of 75% improvement was similar for PGA×BSA and PASI.

scholarly journals Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e032552 ◽  
Author(s):  
Bernd Schweikert ◽  
Chiara Malmberg ◽  
Mercedes Núñez ◽  
Tatiana Dilla ◽  
Christophe Sapin ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Cost Effectiveness ◽  
Maintenance Therapy ◽  
Induction Period ◽  
Severity Index ◽  
Cost Effectiveness Analysis ◽  
Severe Psoriasis ◽  
Base Case ◽  
Psoriasis Area Severity Index ◽  
Effectiveness Analysis

ObjectiveTo conduct a cost-effectiveness analysis from the perspective of the Spanish National Health System (NHS) comparing ixekizumab versus secukinumab.DesignA Markov model with a lifetime horizon and monthly cycles was developed based on the York model. Four health states were included: a biological disease-modifying antirheumatic drug (bDMARD) induction period of 12 or 16 weeks, maintenance therapy, best supportive care (BSC) and death. Treatment response was assessed based on both Psoriatic Arthritis Response Criteria (PsARC) and ≥90% improvement in the Psoriasis Area Severity Index score (PASI90). At the end of the induction period, responders transitioned to maintenance therapy. Non-responders and patients who discontinued maintenance therapy transitioned to BSC. Clinical efficacy data were derived from a network meta-analysis. Health utilities were generated by applying a regression analysis to Psoriasis Area Severity Index and Health Assessment Questionnaire‒Disability Index scores collected in the ixekizumab SPIRIT studies. Results were subject to extensive sensitivity and scenario analysis.SettingSpanish NHS.ParticipantsA hypothetical cohort of bDMARD-naïve patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis was modelled.InterventionsIxekizumab and secukinumab.ResultsIxekizumab performed favourably over secukinumab in the base-case analysis, although cost savings and quality-adjusted life-year (QALY) gains were modest. Total costs were €153 901 compared with €156 559 for secukinumab (difference −€2658). Total QALYs were 9.175 vs 9.082 (difference 0.093). Base-case results were most sensitive to the annual bDMARD discontinuation rate and the modification of PsARC and PASI90 response to ixekizumab or secukinumab.ConclusionIxekizumab provided more QALYs at a lower cost than secukinumab, with differences being on a relatively small scale. Sensitivity analysis showed that base-case results were generally robust to changes in most input parameters.Trial registration numberSPIRIT-P1: NCT01695239; Post-results, SPIRIT-P2: NCT02349295; Post-results.

scholarly journals Treatment of moderate to severe psoriasis with apremilast over 2 years in the context of long-term treated HIV infection: A case report

2019 ◽  
Vol 7 ◽  
pp. 2050313X1984519 ◽  
Author(s):  
Misha Zarbafian ◽  
Benoit Cote ◽  
Vincent Richer
Keyword(s):  
Hiv Infection ◽  
Opportunistic Infections ◽  
Total Body Surface Area ◽  
Undetectable Viral Load ◽  
Severity Index ◽  
Severe Psoriasis ◽  
Psoriasis Area Severity Index ◽  
Quality Of Life Index ◽  
Pasi Score ◽  
Total Body

Treatment of moderate-to-severe psoriasis in patients with HIV infection is a clinical challenge. We present the case of a patient with a longstanding history of well-controlled HIV. He had failed topical management, and his hypertriglyceridemia made use of acitretin potentially unsafe. He was unable to regularly attend a phototherapy unit. Physical examination revealed 12% total body surface area involvement with a Psoriasis Area Severity Index (PASI) of 10.2. His Dermatology Quality of Life Index (DLQI) was 20. After 3 months of apremilast treatment, his PASI decreased to 4.1. After 7 months, his PASI decreased to 2.7 and his DLQI to 1. Two years later, his PASI score was 2.4, with a stable CD4 count of 1200 cells/mm3 and an undetectable viral load. There were no serious opportunistic infections or laboratory abnormalities. To our knowledge, this represents the second reported case of psoriasis treatment with apremilast in a patient with HIV.

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