A5040000631- Diet and metabolism studies
- Allergic Rhinitis and Sensitization
- Metabolism and Genetic Disorders
- Dermatology and Skin Diseases
- Inflammatory Bowel Disease
- Child and Adolescent Psychosocial and Emotional Development
- Liver Disease Diagnosis and Treatment
- Oral Health Pathology and Treatment
- Digestive system and related health
- Alcoholism and Thiamine Deficiency
- Systemic Sclerosis and Related Diseases
- Systemic Lupus Erythematosus Research
- Autoimmune and Inflammatory Disorders
- Salivary Gland Tumors Diagnosis and Treatment
- Nursing Diagnosis and Documentation
- Eating Disorders and Behaviors
- Stress Responses and Cortisol
- Behavioral Health and Interventions
- Olfactory and Sensory Function Studies
- Food Allergy and Anaphylaxis Research
- Health Education and Validation
- Salivary Gland Disorders and Functions
- Sinusitis and nasal conditions
- Delphi Technique in Research
- Microscopic Colitis
Adelphi Group (United Kingdom)
2020-2024
Most patient-reported outcome (PRO) instruments that measure atopic dermatitis (AD) symptoms do not have sufficient documented evidence of content validity to satisfy regulatory agency guidance for inclusion in product-labelling claims the USA or Europe. The objective this study was develop a PRO instrument accordance with assess daily AD during course therapy and establish its psychometric properties. Pruritus Symptoms Assessment Atopic Dermatitis (PSAAD) diary developed based on...
SLE and lupus nephritis (LN) have significant impacts on the health-related quality of life patients living with condition, which are important to capture from patient's perspective using patient-reported outcomes (PROs). The objectives this study were evaluate content validity PROs commonly used in LN (36-Item Short Form Health Survey (SF-36), Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) Lupus Quality Life (LupusQoL), as well novel PRO symptom severity items measuring...
Long-chain fatty acid oxidation disorders (LC-FAOD) are a group of rare autosomal-recessive genetic characterized by metabolic deficiencies in which the body is unable to convert long-chain acids into energy. To date, however, there limited understanding patient experience LC-FAOD.The symptoms, observable signs, and quality life (QoL) impacts associated with LC-FAOD were explored via focus (n = 8) semi-structured interviews 6) patients caregivers LC-FAOD, 4) expert clinicians. Data analyzed...
To date, no patient-reported outcome measures have been specifically developed to assess pharmacological treatment effect in participants with severe chronic rhinosinusitis (CRS) recurrent bilateral nasal polyps (NP). These studies aimed (1) the psychometric properties and (2) content validity of Visual Analogue Scales (VAS) assessing NP symptom severity.(1) Retrospective validation study using clinical trial data cross-sectional qualitative patient interview study.(1) Multicentre trial;...
European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) is a clinician-reported outcome (ClinRO) instrument, assessing disease activity from the physician perspective. EULAR Patient Reported (ESSPRI) patient-reported (PRO) patient-defined symptom severity. Both instruments are commonly used as clinical trial endpoints and have been psychometrically validated. However, qualitative evidence supporting content validity what constitutes...
Pediatric asthma has been identified by regulators, clinicians, clinical trial sponsors, and caregivers as an area in need of novel fit-for-purpose outcome assessments (COAs) developed accordance with the U.S. Food Drug Administration's (FDA's) regulatory guidance for evaluating benefit treatment trials. To address this gap, Patient-Reported Outcome (PRO) Consortium's Asthma Working Group continued development 2 COAs to assess signs symptoms pediatric trials support efficacy endpoints: a PRO...