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. Methods: Ten respondents who were members of the ISOQOL's CP-SIG and worked in various clinical areas, participated in a survey or telephone interview. Participants were from Canada (n=2), Denmark (n=1), England (n=2), Holland (n=1) and the United States (n=4). Results: Based on the information provided by respondents, a Companion Guide was produced, organized according to the nine questions presented in the User's Guide. An additional section for key take-home messages was also provided. This guide provides examples of issues and considerations related to the implementation of PRO measures in clinical practice. Conclusions: Respondents provided insight into their experiences and emphasized that PRO initiatives were likely to be more successful if there is purposeful, designed integration into clinical practice, meaningful substantive engagement with all stakeholders and access to necessary organizational resources. The ability to leverage existing technology as well as realistic and stakeholder consensus-driven expectations for planning and timing were also key to the successful implementation of PRO measures.

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. The first part of the study included three stages: in-person concept elicitation (CE) interviews, a 2-week daily electronic diary (eDiary) study, and in-person cognitive debriefing (CD) interviews. An Itch numeric rating scale (NRS) (v1.0) and a Skin Pain NRS (v1.0) evaluation during CD interviews required participants to think about their ‘worst’ itch and ‘worst’ skin pain in the past 24 h. Other PRO measures allowed for psychometric testing. The second part of the study involved telephone-depth interviews (TDIs) and qualitative feedback from participants who had not participated in the CD interviews. Qualitative data were thematically analyzed. Psychometric evaluation of NRS measures was performed using eDiary data. Results In the CE interviews, itch and/or itching and skin pain were the most prevalent symptoms consistently discussed by participants. Both NRS measures demonstrated strong psychometric reliability and were applicable across ages with suitable concurrent validity. During the CD interviews, some participants focused their answers on their ‘average’ itch/itching in the past 24 h, rather than their ‘worst’ itch. Some participants answered the Skin Pain NRS thinking about general pain or other types of pain, rather than skin pain specifically. Consequently, modifications to both measures addressed these issues and re-tested as paper-and-pen versions in subsequent TDIs. Itch NRS (v2.0) modifications helped participants focus on their worst itching. Most participants preferred Skin Pain NRS v2.0b, which included skin pain descriptors. Conclusions Itching and skin pain are the most important and relevant AD symptoms. The Itch NRS (v2.0) and Skin Pain NRS (v2.0b) appear to be appropriate endpoints for the assessment of itching and skin pain severity for clinical trials with adults and adolescents with AD.

BackgroundUlcerative 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.MethodsTo 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). Eligibility and medical history were confirmed by clinician report. A previously conducted literature review and resultant conceptual model informed the discussion guide to explore symptoms and HRQoL. Age appropriate creative tasks (“animal” task and collage) were employed to facilitate discussion. Transcripts and collages were subjected to thematic analysis using ATLAS.ti software.ResultsClinician-reported UC severity included 24% mild, 38% moderate, 38% severe among adults; and 64% mild, 29% moderate, 7% severe among adolescents. Among adults, 52% were female, 67% were white. Among adolescents, 50% were female, 71% were white. During analysis it was noted that all participants reported stomach/abdominal pain. Other key symptoms identified were frequent bowel movements, diarrhea, blood in stools, sudden need for bowel movement, stomach cramping, bloating, and feeling gassy/passing gas (≥75% of participants). Key impacts identified were embarrassment, dietary limitations, having to plan around UC, worry/fear, anger, low mood/depression, and relationship with others, (≥75% of participants). In creative tasks, animals were chosen to represent their UC and content included in the collages reflected the most commonly discussed themes from the interviews. Only adults discussed feeling dehydrated, while only adolescents discussed the impact of UC on school life.ConclusionsOpen-ended interviews highlighted the HRQoL and symptomatic experiences of UC from the patient’s perspective, which were similar between adult and adolescent UC patients.

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An awareness of the specific cultural learning needs of international nursing students is an important first step to the provision of culturally competent supervision for this cohort of students. There is an urgent need for education and role preparation for all registered nurses supervising international nursing students, along with adequate recognition of the additional time required to effectively supervise these students.