Objectives Systemic lupus erythematosus (SLE) is a chronic autoimmune condition with heterogeneous presentation and Supplementary file 1. [hackbus.info] . [DOWNLOAD PDF] The Lupus Cookbook: Anti-Inflammatory Recipes to Live Well With Lupus Free Epub/MOBI/EBooks. Often considered the prototypic autoimmune disease, Lupus is characterized by protean Digitally watermarked, DRM-free; Included format: PDF, EPUB; ebooks can be used on all reading devices; Immediate eBook download after purchase.
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Original Article. Systemic lupus erythematosus (SLE) is a prototype CNS lupus, arthritis and skin involvements. The . Epub Mar. PDF | The epidemiology of systemic lupus erythematosus (SLE) in Africa is largely by guest on November 3, hackbus.infonloaded from. PDF | Systemic lupus erythematosus (SLE) is a chronic, multisystem Open Access Rheumatology: Research and Reviews downloaded from.
Conventional immunosuppressive therapies have radically transformed patient survivalin systemic lupus erythematosus SLE , but their use is associated with considerabletoxicity and a substantial proportion of patients remain refractory to treatment. Amore comprehensive understanding of the complexity of SLE immunopathogenesis hasevolved over the past decade and has led to the testing of several biologic agents inclinical trials. There is a clear need for new therapeutic agents that overcome theseissues, and biologic agents offer exciting prospects as future SLE therapies. Systemic lupus erythematosus SLE is a complex autoimmune rheumatic disease,characterized by unpredictable exacerbations and remissions. Theprevalence of SLE varies significantly in different ethnic groups. The overall prevalence of SLE in theUK is approximately 28 per , head of population, rising to approximately per, in Afro-Caribbean females [ 3 ].
Provides internists and rheumatologists with the essentials of lupus diagnosis and treatment Easily readable and concise Written by leading experts in the field see more benefits. Buy eBook. Buy Hardcover. Buy Softcover. Rent the eBook. FAQ Policy.
About this book Often considered the prototypic autoimmune disease, Lupus is characterized by protean manifestations and affects a wide range of organ systems. Show all. From the reviews: Pages The Treatment of Lupus: To enable worldwide use of the PROs, translators assessed whether the questionnaires could be readily translated into three etymologically distinct languages German, Japanese, and Portuguese.
Based on the CD interviews, clinician input, and the translatability assessment, both PROs were revised. All interviews were recorded and transcribed for analysis; patient identifiable information was not included in any transcripts or analyses to ensure patient confidentiality.
All data were held in strict confidence in accordance with local, state, and federal law. A coding dictionary was developed and used in the thematic analysis. Each transcript was coded by one coder, then reviewed, summarized, and analyzed by a second coder. In addition to analyzing the data from the code book, representative quotes were reviewed. In this way, the rich patient narratives were converted into the final list of symptoms included in the SSD and the impacts described in the SIQ.
Safety was not assessed in the study; however, if patients reported an adverse event during the interview, they were instructed to report it to their healthcare provider; if relevant this was also reported to the study sponsor. SF a [ 11 ]. General population surveys and clinical trials to estimate disease burden and compare disease-specific benchmarks with general population norms.
Generic measure of physical and mental functioning with 36 items contributing to 8 subscales: LupusQoL [ 16 ]. LupusPRO [ 17 ]. L-QoL [ 29 , 32 ]. SSC [ 21 ]. Lup-QOL [ 32 , 33 ].
Includes 19 items with generic and disease-specific components including symptoms and interference, cognitive and confidence and planning. Existing measures were also found to be insufficient as their development lacked substantial, documented input from patients with SLE e.
It was, therefore, concluded that the development of novel measures to evaluate symptoms and impacts would be of value for both clinical research and clinical practice. CD interviews to assess the content and clarity of the draft questionnaires were completed by a second group of 18 patients with SLE: At the final round of CD interviews there was little new information gained.
The majority of instructions and questions were found to be clear and concise and could be paraphrased correctly by most patients. As the majority of patients thought the 0—10 response scale was appropriate, and no patients indicated they would prefer a different set of response options, the point NRS was retained.
Novel therapeutic agents in clinical development for systemic lupus erythematosus
As a result of the translatability assessment, minor revisions were made to some questions and the instructions. People with lupus may experience a variety of symptoms.
Please indicate how severe the following lupus symptoms were at their worst in the past 24 hours by selecting one number. Sample questions from the SIQ: Seventeen patients completed CD interviews of the SIQ; due to the length of the questionnaire, it was not feasible to cognitively debrief all items, therefore, items with words or terms that were more complex or could potentially have more than one interpretation were focused upon.
For example, patients were debriefed on whether they considered the terms joint pain and joint stiffness to be the same, whether questions referring to both symptoms should be included, whether they should be kept as separate items and if they answered questions referring to them differently. Most revisions to the SIQ involved combining similar items or making minor wording changes to enhance translatability.
As such, a numeric rating of this impact would not necessarily be familiar or meaningful to patients. In addition, unlike the SSD, which is administered daily, the SIQ is administered weekly, as symptom impacts are less likely to change on a daily basis.
A Likert-type scale is appropriate for detecting these changes in impacts, as it is easy for respondents to understand and still sensitive enough to detect subtle changes [ 26 ]. Sample items are provided in Table 4. Existing PROs were either designed for different purposes e. Although the LupusPRO and LIT may have been developed in alignment with best measurement science, with content validity in the target population of interest and adequate measurement properties as required by the FDA, to the best of our knowledge, at the time of this study there was not comprehensive, publicly available, documented evidence that demonstrated this.
Patients reported that the PROs were clear, comprehensive, and relevant. Minor modifications to the draft PROs were made based on patient feedback, further clinician input, and an assessment of translatability.
Best scientific practices, as described in the FDA PRO Guidance [ 4 ], were followed throughout the development of both PROs, including an iterative development methodology and substantial patient input. Sample sizes were sufficient to support their development. We are confident that the CD sample size was sufficient and all items were evaluated satisfactorily; by the final round of reviewing there was little new information gained from the interviews.
Both Caucasian and African American patients were interviewed, and patients with a wide range of disease duration were included.
There were some instances where patients with mild SLE did not believe an item was relevant because they had not experienced it; therefore, it is important that future evaluation of the PROs includes patients with severe SLE. It may have been possible to obtain a more representative sample if a larger number of patients had been recruited instead of purposely selecting patients to generate a diverse sample for characteristics including age, race, disease severity and time since diagnosis.
Background demographic and clinical information was not collected from patients not eligible to participate or who declined to participate in the study, so it is unclear whether our patient population is representative of the total population approached. Another potential limitation of this study is that not all questions were asked of all patients during the cognitive debriefing of the instruments, therefore in some cases the sample size was smaller. Despite some limitations, primarily related to the characteristics of the study participants, using patient input to inform the content of the PROs enabled the inclusion of concepts that are most important and relevant to patients.
Importantly they were developed in accordance with the FDA PRO Guidance [ 4 ] and may be appropriate in a specified context to support claims in approved medical product labelling. Also, both PROs have been developed for electronic administration to enable patients to complete them regularly and with ease, and ensure more accurate reporting while minimizing missing data.
Previously, ePROs have been demonstrated to be a feasible and convenient tool for patients with chronic inflammatory disease [ 31 ].
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Prior to use, it will be necessary to perform exploratory factor analysis for both PROs, in order to confirm the structure of each scale and develop scoring algorithms. Without this information, only item level data can be presented descriptively. In addition, the measurement properties of the questionnaires, including internal consistency reliability, test-retest reliability, construct validity, known groups validity, responsiveness to change over time, and an estimation of what change is clinically meaningful should be evaluated.
Development of a responder definition will support the interpretation of scale scores. We assessed the translatability of the PROs into three distinct languages; if it becomes necessary to translate the PROs in to other languages, further modifications may be required to ensure conceptual equivalence.
Following psychometric testing and adequate demonstration of the required measurement properties, these tools can be used in clinical research and clinical practice to assess the symptoms and impacts experienced by patients with SLE.
(PDF) Management of systemic lupus erythematosus during pregnancy: Challenges and solutions
American College of Rheumatology. European Medicines Agency. Food and Drug Administration. Lupus Impact Tracker. Lupus Patient Reported Outcome questionnaire. Lupus Quality of Life questionnaire. Short Form SLE Impact questionnaire. Systemic Lupus Activity Questionnaire. SLE-specific Quality of Life. The study was funded by GSK plc. GSK contributed to the development of the study concept and design, conducted the study, and contributed to the interpretation of the data.
GSK supported the authors in development of the manuscript. At this time, no additional data will be shared as the tools were developed to generate evidence to demonstrate treatment benefits of GlaxoSmithKline GSK therapies for SLE that are still in development and to differentiate them from competitor treatments.
PB contributed to the conception and interpretation of this study. KP contributed to the analysis and interpretation of the study. All authors contributed to the drafting and revising of this manuscript and have approved the final version for publication. Independent review board approval Copernicus Group; reference number: HOS1— was obtained. All patients provided written informed consent to participate in the study.
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Research Open Access. Patient experience in systemic lupus erythematosus: Mathias 1 Email author , P. Berry 2 , J. De Vries 3 , K. Pascoe 3 , H. Colwell 1 , D.
Chang 2 and A. Askanase 4. Journal of Patient-Reported Outcomes 2: Abstract Background Comprehensive assessment of systemic lupus erythematosus SLE and its treatment requires patient-reported outcome PRO measures to capture impacts and fluctuating symptoms. Methods Following independent review board approval, six US rheumatology practices recruited patients with SLE to participate in concept elicitation CE interviews, in order to identify important SLE symptoms and their impacts.
Results Forty-one patients completed CE interviews. Patient experience Patient-reported outcomes Questionnaire Systemic lupus erythematosus Symptoms.
Study design A detailed research protocol was developed in accordance with best measurement science Fig. PRO Concept measured Intended use Content Recall period SF a [ 11 ] HRQoL General population surveys and clinical trials to estimate disease burden and compare disease-specific benchmarks with general population norms Generic measure of physical and mental functioning with 36 items contributing to 8 subscales: Includes 19 items with generic and disease-specific components including symptoms and interference, cognitive and confidence and planning Varies according to the item SSD Symptoms Patients with SLE in clinical trials and practice 17 items measuring SLE symptoms including: CE interviews were completed by 41 patients 3—10 patients from each study site: Table 2 Demographic and clinical characteristics of patients.
I enjoy company of other people. I ran organizations. I had a lot of friends. In the CE interviews, patients reported daily fluctuations in symptoms. For these reasons, items with short recall periods or items that ask patients to describe their current or recent state are usually preferable.
Sample questions from the SSD: American College of Rheumatology CD: Short Form SIQ: Funding The study was funded by GSK plc.
Availability of data and materials At this time, no additional data will be shared as the tools were developed to generate evidence to demonstrate treatment benefits of GlaxoSmithKline GSK therapies for SLE that are still in development and to differentiate them from competitor treatments.
Ethics approval and consent to participate Independent review board approval Copernicus Group; reference number: Consent for publication Not applicable. Guidelines for referral and management of systemic lupus erythematosus in adults.