Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis.

Background: Pruritus, or itch, is a key symptom of atopic dermatitis (AD); as such, mitigating itch is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Pruritus Numeric Rating Scale (Pruritus NRS), a novel single-item scale for assessing itch severity in clinical trials of AD treatments.

Methods: In this mixed-methods study, qualitative interviews were conducted with 21 people with moderate-to-severe AD (n = 15 adult, n = 6 adolescent) to develop a conceptual model of the patient experience in AD and explore the content validity of the Pruritus NRS.

Standardising personalised diabetes care across European health settings: A person-centred outcome set agreed in a multinational Delphi study.

Objective: Standardised person-reported outcomes (PRO) data can contextualise clinical outcomes enabling precision diabetes monitoring and care. Comprehensive outcome sets can guide this process, but their implementation in routine diabetes care has remained challenging and unsuccessful at international level. We aimed to address this by developing a person-centred outcome set for Type 1 and Type 2 diabetes, using a methodology with prospects for increased implementability and sustainability in international health settings.

Which diabetes specific patient reported outcomes should be measured in routine care? A systematic review to inform a core outcome set for adults with Type 1 and 2 diabetes mellitus: The European Health Outcomes Observatory (H2O) programme.

Objectives: The objective was to identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine care, as part of an international project to enhance care outcomes for people with diabetes.

Methods: PubMed, COSMIN and COMET databases were searched. Published studies were included if they recommended patient reported outcomes that were clinically useful and/or important to people with diabetes.

Validation of the bowel urgency numeric rating scale in patients with Crohn's disease: results from a mixed methods study.

Purpose: Bowel urgency (BU) is an important symptom of Crohn's disease (CD), however there is no patient-reported outcome (PRO) scale validated in this population to assess BU severity. Here we evaluated the content validity and psychometric properties of the Urgency Numeric Rating Scale (NRS).

Method: Qualitative interviews were conducted with moderate-to-severe CD participants to confirm importance and relevance of BU in this population, cognitively debrief the Urgency NRS, and explore score interpretation and CD remission.

Real-world treatment patterns of immunosuppressants in Adults with systemic lupus erythematosus: A claims database analysis in the United States.

Objective: To explore initiation, persistence, and adherence to secondline prescribed treatments for SLE, specifically regarding the immunosuppressants azathioprine, methotrexate, and mycophenolate (conventional DMARDs), and belimumab (a biologic).

Methods: Clinical and insurance records were obtained for 801 patients with SLE who initiated treatment with azathioprine, belimumab, methotrexate, or mycophenolate between July 2015 and June 2019. The date of initiation defined the index date, with a 6-month pre-index and 12-month post-index period.

Patient-reported disease impact of systemic lupus erythematosus with active joint symptoms: Results from the systemic lupus erythematosus-update survey.

Background: Many people with systemic lupus erythematosus (SLE) experience joint pain, swelling, and stiffness. These joint symptoms are associated with problems in physical functioning and work disability. We used survey data from adults with SLE to explore the burden and impact of joint symptoms.

Co-creation of practical "how-to guides" for patient engagement in key phases of medicines development-from theory to implementation.

Background: The effective impact of patient engagement (PE) across the medicines development continuum is widely acknowledged across diverse health stakeholder groups, including health authorities; however, the practical applications of how to implement meaningful and consistent PE are not always addressed. Guidance for the practical implementation of PE requires granularity, and the need for such guidance has been identified as a priority. We describe the co-production and summarize the content of how-to guides that focus on PE in the early stages of medicines development.

A qualitative study to explore symptoms and impacts of pediatric and adolescent Crohn's disease from patient and caregiver perspective.

Background: Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that affects people across the age spectrum but often starts in childhood or early adulthood. Despite this, almost all published research examining the symptomatic and health-related quality of life (HRQL) experiences of CD has been conducted in an adult population. Studies providing a comprehensive overview of the lived experience of pediatric and adolescent CD are virtually non-existent.

Patient Experiences, Satisfaction, and Expectations with Current Systemic Lupus Erythematosus Treatment: Results of the SLE-UPDATE Survey.

Objectives: To provide information on systemic lupus erythematosus (SLE) patients' experiences, satisfaction, and expectations with treatments and examine the association between treatment satisfaction and patient-reported outcomes (PRO).

Methods: A cross-sectional, non-interventional, online survey of US adult patients with SLE was conducted in 2019. The survey consisted of 104 questions about SLE and the following PRO instruments: LupusPRO™, Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue, Work Productivity and Activity Impairment (WPAI), an 11-point Worst Pain Numerical Rating scale (NRS), and an 11-point Worst Joint Pain NRS.

Qualitative research to explore the symptoms and impacts experienced by children with ulcerative colitis.

Background: Ulcerative Colitis (UC) is a chronic gastrointestinal disease that often presents during one's most productive years and is characterized by colon inflammation. Key symptoms and impacts in adults are well-known, however, experiences among pediatric populations have not been well documented. The purpose of this study was to understand the health-related quality of life and symptomatic experience of children (2-11 years) living with UC.

Patient's Perspective on Disease Burden, Remission Definition, and Symptoms Associated With Treatment Seeking: A Qualitative Study in Adult and Adolescent Patients With Crohn's Disease.

Background: Disease burden, a definition of remission, and symptoms that drive treatment seeking were explored in a Crohn's disease (CD) population.

Methods: A qualitative semistructured interview guide was developed, informed by published literature. Clinicians identified adolescents and adult patients with CD.

Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative.

Introduction: Meaningful patient engagement (PE) can enhance medicines' development. However, the current PE landscape is fragmentary and lacking comprehensive guidance.

Methods: We systematically searched for PE initiatives (SYNaPsE database/publications).

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

Aims: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry.

Methods: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals.

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance.

In recent years, pharmacovigilance has undergone some major changes. First, the patient's active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT).

Role of viruses and atypical bacteria in exacerbations of asthma in hospitalized children: a prospective study in the Nord-Pas de Calais region (France).

We studied the role of viruses and atypical bacteria in children hospitalized with exacerbated asthma by a prospective study of children with acute asthma admitted to the Department of Pediatrics in Lille, and to 15 hospitals in the Nord-Pas de Calais region, from October 1, 1998-June 30, 1999. We included children aged 2-16 years with active asthma, defined as three or more recurrent episodes of reversible wheezing. The severity of asthma and of asthmatic exacerbations was recorded.