Clinical Outcome Measures of Psoriasis (original) (raw)
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Journal of Investigative Dermatology, 2010
Background A large number of clinical measures of psoriasis are used in clinical trials and daily practice. These measures lack uniformity and validation. Valid outcome and severity measures for psoriasis are a prerequisite for fully informative clinical research and evidence based medicine. Purpose To identify all clinical measures of psoriasis severity and outcome in use and to evaluate the quality of these measures using clinimetric criteria. Results We identified 53 separate clinical measures and they were regrouped into 11 measures for quality analysis. No measure could be scored on all items used in the clinimetric analysis. The Lattice System Physician's Global Assessment and Physician's Global Assessment were most highly noted. Conclusions None of the psoriasis measures is adequately validated. The Psoriasis Area and Severity Index is the most commonly used clinical measure in research, but has substantial limitations including low response distribution, no consensus on interpretability and low responsiveness in mild disease. Nevertheless, because of its widespread use the Psoriasis Area and Severity Index permits some degree of comparison of results among clinical trials. Overall, no best instrument was identified and different situations may call for different measures.
Outcome Measures of Psoriasis in Clinical Trials: An Overview
Journal of Medical Science And clinical Research, 2016
Psoriasis is a common chronic inflammatory dermatological disorder resulting from interactions between genetic predisposition and triggering environmental factors. It affects approximately 1-3% of the population and poses a lifelong burden on those, affected. Psoriasis typically follows a relapsing and remitting course. It can occur at any age, although is uncommon in children (0.71%) but the majority of cases occur before 35 years. Psoriasis is associated with arthritis in a significant proportion of patients (reported in one study at 13.8%). Usually the psoriasis is not life threatening but it can be life ruining due to its visibility. In clinical trials, several outcome measures have been used to assess the severity of psoriasis. The common outcome measures include PASI (psoriasis area and severity index) score,
The British journal of dermatology, 2012
Summary Background As moderate to severe psoriasis is a systemic disease with large effects on health-related quality of life, generic measures that include overall health, not only skin involvement, are necessary. Knowledge about the relationship between the generic preference-based EuroQol 5D (EQ-5D) and dermatology-specific measures in psoriasis is limited.Objectives To analyse EQ-5D, the Dermatology Life Quality Index (DLQI) and the Psoriasis Area and Severity Index (PASI) in patients with moderate to severe psoriasis in Swedish clinical practice by demographic characteristics, to compare EQ-5D among patients vs. Swedish population values, and to analyse the relationships between EQ-5D, DLQI and PASI.Methods This observational cohort study was based on PsoReg, the Swedish National Registry for Systemic Treatment of Psoriasis. EQ-5D was compared among patients with psoriasis vs. a defined general population in Sweden, retrieved from a previous study. Relationships between measures were examined with correlation tests and regression analysis.Results In total, 2450 patients (1479 men and 971 women) were included. Median EQ-5D, DLQI and PASI scores were 0·769, 4 and 4·7, respectively. Patients with psoriasis had a significantly lower EQ-5D compared with the defined general population. EQ-5D correlated moderately with DLQI (−0·55) and weakly with PASI (−0·25) (P < 0·001).Conclusions When assessing psoriasis treatments and making decisions about treatment guidelines and resource allocation, EQ-5D, DLQI and PASI provide a useful set of complementary tools, answering to different needs. If EQ-5D is not included in the original trial the second-best option in cost-effectiveness studies is to use mapping between DLQI and EQ-5D.
BMC Medical …, 2011
Background: Observational studies, if conducted appropriately, play an important role in the decision-making process providing invaluable information on effectiveness, patient-reported outcomes and costs in a real-world environment. We conducted a systematic review of large-scale, prospective, cohort studies with the aim of (a) summarising design characteristics, the interventions or aspects of the disease studied and the outcomes measured and (b) investigating methodological quality. Methods: We included prospective, cohort studies which included at least 100 adults with psoriasis or psoriatic arthritis. Studies were identified through searches in electronic databases (Pubmed, Medline, Cochrane library, Centre for Reviews and Dissemination). Information on study characteristics were extracted and tabulated and quality assessment, using a checklist of 18 questions, was conducted.
The Journal of rheumatology, 2014
In the United States, access to care is the number one issue facing our patients with dermatological conditions. In part, this is because we do not have outcome measures that are useful in clinical practice and available in databases where payers and governmental agencies can compare the performance of physicians and treatments. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials and subsequently in clinical practice. The International Dermatology Outcome Measures group includes all willing stakeholders: patients, physicians, payers, and pharmaceutical scientists. As reported herein, the group's goal is to develop outcome measures in dermatology that address the needs of all involved.
Journal of the American Academy of Dermatology, 2012
Background: Although there are many psoriasis assessment tools currently published, one of the unmet needs in psoriasis research remains consensus about the single best validated and reproducible assessment tool. Objectives: In this systematic review we sought to determine the degree of correlation between two commonly used psoriasis assessment tools, the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA). Methods: Randomized controlled systemic trials in moderate to severe psoriasis were reviewed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We recorded and compared the percent of patients achieving both 75% reduction in PASI score (PASI 75) and PGA 0 or 1 (clear or almost clear) at 8 to 16 weeks, 17 to 24 weeks, and greater than 24 weeks of treatment with the investigational drug. Results: Our literature review yielded 30 randomized controlled trials using biologic agents in moderate to severe psoriasis. We found that the two assessment tools correlate very tightly except at the lower bounds of therapeutic efficacy. The r 2 values for the correlation between PASI 75 and a score of clear or almost clear on the PGA were 0.9157 at 8 to 16 weeks and 0.892 at 17 to 24 weeks. Limitations: Limitations of our study include the small number of randomized controlled trials publishing the percent of patients achieving 75% reduction in PASI score and a score of clear or almost clear on the PGA after 24 weeks of therapy. In addition, our results are not generalizable beyond the patients with moderate to severe plaque psoriasis. Conclusion: The two assessment tools are substantially redundant and either alone is a sufficient tool for assessing psoriasis severity in patients with moderate to severe disease. Because the PASI is better validated and more detailed, it remains the score of choice for clinical trials, but the simpler PGA may be well suited for community-based outcomes projects.
Clinical evaluation of different therapeutic modalities in psoriasis by Pasi score
Our Dermatol Online, 2013
Psoriasis is a chronic recurrent papulosquamous disorder characterized by epidermal hyperplasia. The management of psoriasis can be challenging. Although, there are many therapeutic modalities available but still there are no clear cut guidelines regarding the usage of different modalities depending on the severity of psoriasis evaluated by PASI score. Taking this into consideration, a randomized controlled trial was undertaken to clinically evaluate different therapeutic modalities in psoriasis by PASI scoring. We selected fifty clinically diagnosed cases of psoriasis and confirmed by histopathology. The patients were put on different modalities depending on the psoriasis area and severity index score (PASI score) and all the patients were followed up to 24 weeks for any relapse.
Psoriasis is a chronic condition that has a significant negative impact on a patient’s quality of life (QoL). Measures of the clinical severity of psoriasis alone may not reflect patients’ perceptions of the impact of the disease on their lives. The aim of our study was to assess QoL in psoriasis patients who were candidates to receive one of the new biological treatments in order to obtain a more complete evaluation of the severity of the disease prior to treatment. A total of 180 patients were analysed, with all being affected by plaquetype psoriasis. The clinical severity of psoriasis was assessed by the Psoriasis Area and Severity Index, while QoL was assessed by three measures: the Dermatology Life Quality Index, the Skindex-29, and the Psoriasis Disability Index. Our results show how pervasive the impact of psoriasis is in patients who are candidates for the new biological treatments, and they further confirm the lack of a strong correlation between measures of clinical severity and QoL.