Developing Angelman syndrome-specific clinician-reported and caregiver-reported measures to support holistic, patient-centered drug development.

Background: Angelman syndrome (AS) is a rare, heterogenous neurogenetic condition, which significantly impacts the lives of people with AS and their families. Valid and reliable measures reporting key symptoms and functional impairments of AS are required to support development of patient-centered therapies. We describe the development of clinician- and caregiver-reported, AS-specific Global Impression scales for incorporation into clinical trials.

Summary of Research: Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

This is a summary of the original article 'Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)'. Individuals with insomnia are best positioned to assess the impact of insomnia on their quality of life. Patient reported outcomes (PROs) are self-reported health measures created to allow people to record their experience of their disease.

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings.

Objective: To quantitatively compare equivalence and compliance of patient-reported outcome (PRO) data collected via provisioned device (PD) versus bring your own device (BYOD).

Methods: Participants with stable chronic obstructive pulmonary disease (COPD) completed the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) daily and COPD Assessment Test™ (CAT) and Patient Global Impression of Severity (PGIS) of COPD weekly on either PD or BYOD for 15 days, then switched device types for 15 days. EXACT was scored using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) algorithm and equivalence assessed using intraclass correlation coefficients (ICCs) adjusting for cross-over sequence, period, and time.

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings.

Background: There is interest in participants using their own smartphones or tablets ("bring your own device"; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies. Our study aimed to qualitatively evaluate participants' experience using a provisioned device (PD) versus their own smartphone (BYOD) for this purpose.

Methods: Participants with chronic obstructive pulmonary disease (COPD) were recruited for this observational, cross-over study and completed PRO measures daily on one device type for 15 days, then switched to the other device type to complete the same measures for another 15 days.

A Patient-Centered Conceptual Model of Symptoms and Their Impact in Early Parkinson's Disease: A Qualitative Study.

Background: Individuals with Parkinson's disease (PD) develop a significant disease burden over time that contributes to a progressive decline in health-related quality of life. There is a paucity of qualitative research to understand symptoms and impacts in individuals with early-stage PD (i.e.

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.

Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

Background And Objective: Chronic insomnia has major consequences for daytime functioning, yet no fully validated patient-reported outcome instrument for once-daily assessments is available to measure these consequences. This study describes the development and psychometric evaluation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

Methods: The Daytime Insomnia Symptom Scale (DISS), an existing 20-item instrument for assessing daytime functioning, was modified to give an 18-item version of the IDSIQ (IDSIQ-18) based on iterative qualitative interviews with 54 subjects with insomnia and expert input.

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.

A qualitative study exploring the health-related quality of life and symptomatic experiences of adults and adolescents with ulcerative colitis.

Background: Ulcerative colitis (UC) often first presents during adolescence and early adulthood. Primary symptoms of UC are well known, yet similarities and differences of disease experience in adults and adolescents are not well characterized.

Methods: To understand the health-related quality of life (HRQoL) and symptomatic experience of UC, in-depth interviews were conducted in the US with 21 adults (20-70 years) and 14 adolescents (12-17 years).

Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis.

Background: Atopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQoL). The study objective was to understand the patient perspective of AD burden and determine suitable patient-reported outcome (PRO) measures.

Methods: This mixed methods study involved the collection of qualitative and quantitative information from adults (≥ 18 years old) and adolescents (12 - 17 years old) with clinician-confirmed AD regarding their experiences of AD symptoms and its impact on HRQoL.

Implementing patient-reported outcome measures in clinical practice: a companion guide to the ISOQOL user's guide.

Purpose: The use of patient-reported outcome (PRO) measures in clinical practice is increasing. Following the creation of a 'User's Guide to Implementing PRO Assessment in Clinical Practice' by the International Society for Quality of Life Research (ISOQOL), volunteers from ISOQOL sought to create a Companion Guide to assist health care providers with the scientific and practical considerations involved in implementing and using PRO measures in clinical care by using information from real-world case studies. This paper summarizes the key issues presented in the Companion Guide.

Experiences of registered nurses who supervise international nursing students in the clinical and classroom setting: an integrative literature review.

Aims And Objectives: To examine the literature reporting the experiences and perceptions of registered nurses who supervise international nursing students in the clinical and classroom setting.

Background: Nursing education relies on clinical experts to supervise students during classroom and clinical education, and the quality of that supervision has a significant impact on student development and learning. Global migration and internationalisation of nursing education have led to increasing numbers of registered nurses supervising international nursing students.

Cone beam CT dose reduction in prostate radiotherapy using Likert scale methods.

Objective: To use a Likert scale method to optimize image quality (IQ) for cone beam CT (CBCT) soft-tissue matching for image-guided radiotherapy of the prostate.

Methods: 23 males with local/locally advanced prostate cancer had the CBCT IQ assessed using a 4-point Likert scale (4 = excellent, no artefacts; 3 = good, few artefacts; 2 = poor, just able to match; 1 = unsatisfactory, not able to match) at three levels of exposure. The lateral separations of the subjects were also measured.

Review of Penner's criteria for proficiency testing in cytopathology: implications for the redesign of the federally mandated proficiency testing in cytopathology.

Thirty-three years ago Penner advocated six criteria for the performance of proficiency testing in cytopathology (PTC). Since that time, several further requirements have been added by other authors. The present article critically evaluates and modifies the original criteria and adds two more principles, validity and reliability, that we recognize as crucially important in the performance of PTC.

Cytopathology proficiency testing: where do we go from here?

With the recent introduction of nationwide proficiency testing in cytopathology (PTC), reconsideration of several aspects of this controversial quality assurance method becomes justified. This paper discusses various merits and demerits of the PTC system currently prescribed by federal regulations, points out perceived deficiencies, and suggests methods for improvement.