scholarly journals The use of patient-reported outcome research in modern ophthalmology: impact on clinical trials and routine clinical practice

2019 ◽  
Vol Volume 10 ◽  
pp. 9-24 ◽  
Author(s):  
Tasanee Braithwaite ◽  
Melanie Calvert ◽  
Alastair Gray ◽  
Konrad Pesudovs ◽  
Alastair Denniston
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Outcome Research ◽  
Patient Reported Outcome ◽  
Routine Clinical Practice ◽  
Patient Reported

scholarly journals Patient Reported Outcome Measure in Atopic Dermatitis Patients Treated with Dupilumab: 52-Weeks Results

2021 ◽  
Author(s):  
Servando E. Marron ◽  
Lucia Tomas-Aragones ◽  
Carlos A. Moncin-Torres ◽  
Manuel Gomez-Barrera ◽  
Francisco Javier Garcia-Latasa de Aranibar
Keyword(s):  
Quality Of Life ◽  
Atopic Dermatitis ◽  
Clinical Practice ◽  
Stressful Life Events ◽  
Severe Disease ◽  
Patient Reported Outcome ◽  
Routine Clinical Practice ◽  
Severe Atopic Dermatitis ◽  
Patient Reported

Dupilumab is used to treat atopic dermatitis patients who have proven to be refractory to previous treatments. The aim of this study was to assess evolution and patient reported outcome measures in adult patients with moderate-to-severe atopic dermatitis treated with Dupilumab in routine clinical practice. The outcomes were evaluated and registered at baseline and weeks-16, 40 and 52. The variables evaluated were: diseases severity, pruritus, stressful life events, difficulty to sleep, anxiety and depression, quality of life, satisfaction, adherence to the treatment, efficacy and safety. Eleven patients were recruited between Nov 14th 2017 and Jan 16th 2018. Demographic variables: 90% Caucasian, 82% women. Clinical variables: Mean duration of AD =17.7 (±12.8), 91% had severe disease severity. At baseline, SCORAD mean score = 61.7 (±15.5); itch was reported by 100% of patients; itch Visual Analogue Scale mean range of 8 (6-10); HADS mean total score =13.9 (±5.5); DLQI mean score =13.3 (±8.3): EQ-5D-3L mean range = 57 (30-99). At week-52 there is a significant reduction of SCORAD scores, HADS total score and improved quality of life. ¡This study confirms that Dupilumab, used for 52-weeks under routine clinical practice, maintains the improved atopic dermatitis signs and symptoms obtained at week-16, with a good safety profile.

scholarly journals Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Psychometric Properties ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Routine Clinical Practice ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Numeric Rating

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.

The Psoriasis Symptom Inventory: An Effective Patient-reported Outcome Measure of Psoriasis Severity

2015 ◽  
Vol 42 (6) ◽  
pp. 1034-1036 ◽  
Author(s):  
Philip J. Mease
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Severity Index ◽  
Patient Reported Outcome ◽  
Measurement Instruments ◽  
Symptom Inventory ◽  
Clinical Registries ◽  
Patient Reported ◽  
Psoriasis Severity

There is a need for simple, practical, and reliable measurement instruments for use in clinical trials, registries, and clinical practice to assess psoriasis severity and the change in symptoms with treatment. The Psoriasis Area and Severity Index (PASI) is the standard measure of psoriasis used in clinical trials, but it is rarely used in clinical practice and it is not readily used in clinical registries because of its complexity. The Physician Static Global Assessment score is a simpler measure also used in clinical trials and less frequently in registries and practice, but like the PASI, it requires some degree of experience to score. The Psoriasis Symptom Inventory (PSI) was developed as a simple measure to enable patients to self-score psoriasis severity. It has been demonstrated to be reliable and discriminative, and it correlated with the PASI score in a psoriasis clinical trial. It also was recently validated to assess psoriasis in a psoriatic arthritis (PsA) clinical trial. The PSI may be a useful and practical measure of psoriasis severity in psoriasis and PsA clinical trials, registries, and in clinical practice.

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