BACKGROUND: The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin\'s lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale.
METHODS: Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10.
RESULTS: Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (n = 14), fatigue (n = 11), and pain (n = 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms.
CONCLUSIONS: This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.

BACKGROUND: The 12-item Medical Outcomes Study Sleep Scale (MOS Sleep Scale) has been used to capture patient-reported sleep problems in hundreds of studies. A revised version of the MOS Sleep Scale (MOS Sleep-R) was developed that uses simplified response sets, provides interpretable norm-based scoring, and has two recall versions (one-week or four-week). The objective of this study was to evaluate the psychometric properties (reliability and construct validity) of the MOS Sleep-R using data from a representative sample of U.S. adults.
METHODS: Standardization of raw scores into norm-based T-scores (mean = 50, standard deviation = 10) was based on data from a 2009 U.S. internet-based general population survey. The internal consistency reliability of multi-item subscales and global sleep problems indices for both one-week and four-week recall forms of the MOS Sleep-R were examined using Cronbach\'s alphas and inter-item correlations. Construct validity was tested by comparing item-scale correlations between items within subscales with item-scale correlations across subscales. Scale-level convergent validity was tested using correlations with measures including generic health-related quality of life (i.e., SF-36v2) and other relevant outcomes (e.g., job performance, number of days in bed due to illness or injury, happiness/satisfaction with life, frequency of stress/pressure in daily life, the impact of stress/pressure on health, and overall health).
RESULTS: The one-week and four-week recall forms of the MOS Sleep-R were completed by 2045 and 2033 respondents, respectively. The psychometric properties of the one-week and four-week forms were similar. All multi-item subscales and global index scores showed adequate internal consistency reliability (all Cronbach\'s alpha > 0.75). Patterns of inter-item and item-scale correlations support the scaling assumptions of the MOS Sleep-R. Patterns of correlations between MOS Sleep-R scores with criterion measures of health-related quality of life and other outcomes indicated adequate construct validity.
CONCLUSIONS: The MOS Sleep-R introduces a number of revisions to the original survey, including simplified response sets, the introduction of a one-week recall form, and norm-based scoring that enhances interpretability of scores. Both the one-week and four-week recall period forms of the MOS Sleep-R demonstrated good internal consistency reliability and construct validity in a U.S. general population sample.

BACKGROUND: Robust outcome measures are needed to assess and monitor the impact of chronic low back pain (CLBP) on physical functioning. The Roland Morris Disability Questionnaire (RMDQ) is a well-established measure designed to capture the impacts of back pain on everyday functioning, with a particular emphasis on physical functioning. It has documented evaluation of psychometric properties. However, there is no documented qualitative evidence to confirm the content validity of the tool, nor have changes made for electronic administration been debriefed in participants with CLBP.
METHODS: In-depth, semi-structured, concept elicitation and cognitive debriefing interviews were conducted with 23 US participants with confirmed CLBP. Interviews allowed participants to describe the impact of CLBP on their day-to-day functioning and discuss comprehension and suitability of the RMDQ. Interviews were transcribed verbatim and analyzed using thematic analysis.
RESULTS: Concept elicitation and cognitive debriefing revealed the substantial burden associated with CLBP, highlighting 15 key areas of functional impact. These were grouped into overarching themes of mobility (walking, stairs, sitting/standing, bending/kneeling, lifting, lying down), activities (chores/housework, dressing, washing, driving, work) and other (relationships/socializing, mood, sleep, appetite), which are consistent with those evaluated within the RMDQ. All participants found the RMDQ to be relevant with most reporting that the instructions, recall period, and response options were suitable. A few suggested minor changes, however, none were consistent or necessary to support content validity. Updates to the measure for electronic administration and to clarify the response options were well received.
CONCLUSIONS: The qualitative data from individuals with CLBP confirmed that the RMDQ has content validity and, alongside documented psychometric evidence, supports the use of the RMDQ as a reliable and valid tool to assess the impact of CLBP on physical functioning.

BACKGROUND: Patients with plaque psoriasis experience a variety of signs and symptoms that can impact daily life, which may not be evaluated by clinician-reported outcomes. This study aimed to develop and assess the content validity of a new patient-reported outcome (PRO) measure to capture patient experiences of the signs, symptoms and impacts of psoriasis and aid integration of the patient perspective in treatment benefit-risk decision-making.
METHODS: The psoriasis symptoms and impacts measure (P-SIM) was developed based on a literature search and interviews with five clinical experts in psoriasis to identify frequent signs, symptoms and impacts of psoriasis. Hybrid concept elicitation, cognitive debriefing and usability testing interviews were conducted with moderate to severe psoriasis patients to evaluate the content validity and patient understanding of the preliminary P-SIM. The preliminary P-SIM was refined using initial quantitative analyses of phase 2b data from psoriasis patients to inform the removal of any items.
RESULTS: A preliminary 19-item P-SIM was developed for administration on a hand-held electronic tablet device using a 0-10 numerical response scale over a 24-h recall period. Patient interviews and testing demonstrated most patients interpreted the items and responses as intended, would not re-word any items, felt the responses matched the items and rated the device as easy to use. After quantitative testing, five items were removed from the preliminary 19-item measure because of conceptual overlap, floor effects and/or skewed distributions to generate the final 14-item P-SIM.
CONCLUSIONS: The P-SIM questionnaire has good content validity; patients reported it was easy to understand and reflective of their experiences. Following psychometric validation, the P-SIM may be a useful PRO measure for capturing the signs, symptoms and impacts of psoriasis and may support clinician-reported outcomes when assessing treatment benefits in clinical trials.

Since most patients with hepatitis C virus (HCV) infection now receive treatment irrespective of liver disease severity, special attention to patient quality of life (QoL), including psycho-social aspects, is required. No QoL questionnaire is specific for patients with HCV.
To develop and validate a short Italian questionnaire (HepaDisk) assessing the QoL of patients affected by HCV with intuitive graphic results that is understandable by patients and physicians.
A questionnaire, drafted by a steering committee, underwent a Delphi survey. A multicenter, observational study was conducted to validate the developed HepaDisk versus other tools (CLDQ-I, SF-36, WPAI:HCV), and to evaluate its correlation with disease severity in Italian patients with HCV.
The 10-item questionnaire was validated in 214 patients. HepaDisk showed a high correlation with CLDQ overall score and WPAI:HCV activity impairment (Spearman\'s rank correlation: 0.651 and 0.595, respectively) and a lower correlation with SF-36. Strong internal consistency (Cronbach coefficient: 0.912), good test-retest reliability (Pearson\'s correlation coefficient: 0.789; 95% CI, 0.714-0.865), and responsiveness to changes among improved patients were demonstrated.
HepaDisk is a reliable and user-friendly tool that can monitor disease impact on patient QoL over time, providing a visual representation easily understandable by both patients and physicians.

OBJECTIVE: The Penn Facial Pain Scale (Penn-FPS) was originally developed as a supplemental module to the Brief Pain Inventory Pain Interference Index (BPI-PII) in order to fully assess the impact of trigeminal neuralgia (TN) pain on patients\' health-related quality of life (HRQoL). The current objective is to create and establish the content validity of a new stand-alone version of the measure, the Penn-FPS-Revised (Penn-FPS-R).
METHODS: Twenty participants (15 USA and 5 UK) with confirmed TN engaged in concept elicitation and cognitive debriefing interviews. These semi-structured interviews allowed participants to spontaneously describe the ways in which TN impacts on HRQoL and report on the extent to which the Penn-FPS and BPI-PII measure concepts are most relevant to them. Participants were also asked to report on the suitability of the instructions, recall period, and response options.
RESULTS: Concept elicitation revealed nine themes involving TN restrictions on daily activities and HRQoL, including: \"talking,\" \"self-care,\" \"eating,\" \"eating hard foods/chewing foods,\" \"daily activities,\" \"activities with temperature change,\" \"touching,\" \"mood,\" and \"relationships.\" Cognitive debriefing confirmed that all of the Penn-FPS concepts and some of the BPI-PII concepts (\"mood,\" \"general activities,\" and \"relations with others\") were relevant, although some items required edits to better capture individuals\' experiences. The impact of temperature and/or weather on activities was also identified as an important concept that is not captured by the Penn-FPS or BPI-PII. Participants confirmed the acceptability of recall period, instructions, and response options. Results from the interviews were applied to create the Penn-FPS-R, a new brief outcome measure that assesses the impacts of TN most important to patients.
CONCLUSIONS: The Penn-FPS-R is a new 12-item HRQoL outcome measure with content validity that can be used to assess and monitor the impact of TN treatment interventions in both clinical practice and research.

UNASSIGNED: PLM is an online platform that provides tools for individuals to track their health and connect with other patients and while PLM has invited patients to participate in various research projects throughout the years, an examination into what motivates patients to want to get involved in clinical research has not been done. During our analysis of applications submitted by members of the PLM community, we looked for reasons patients want to participate in research and their overall beliefs about clinical research, in general. In addition, we analyzed obstacles and barriers toward patients\' research participation. We observed the following:Patients are typically motivated by their individual needs and are most interested in research specific to their own condition.To get the most from patients\' involvement and to enhance patients\' contribution towards research goals, researchers should explain the research goal and requirements of each goal in clear and transparent terms, making it easy for patients to understand, thus avoiding any potential miscommunication.Future studies are needed to determine the best methods for involving patients in clinical research.
BACKGROUND: Historically, throughout the clinical and medical research arenas, patients have been perceived as passive \"subjects\" rather than as individuals who may have thoughts regarding research development, research plans, implementation of research studies, and data analysis. However, it is becoming more clear that patients increasingly want to have a more active role in clinical research studies and in the management of their own medical conditions as evidenced by a \"no decision about us without us\" stance, meaning patients want to make informed decisions about their health while working alongside their healthcare professionals. The central aim of this research study was to determine patients\' motivations for being involved in research design and understand their perceptions of current research practices.
METHODS: Two independent qualitative studies were conducted. In Study 1, we analyzed applications submitted by self-identified patients from within the PatientsLikeMe (PLM) community, for acceptance onto our advisory panel. The advisory panel was tasked with developing a best practice guide for how to involve patients in research. During the qualitative analysis, we identified major reasons for and topics of interest associated with PLM members\' motivation to apply to the advisory panel. In Study 2, we analyzed applications from PLM community members and from patients outside the PLM community for a patient-led patient-reported-outcome (PRO) development project. Similar to Study 1, we identified themes associated with patients\' motivations to participate in developing a new PRO.
RESULTS: PLM members are interested in being involved in medical research for various reasons, including facilitating provider-patient communication, improving comprehension of medical information, understanding their disease, and bringing a more individualized approach to health care in general.
CONCLUSIONS: Challenges in the process of appropriate involvement of patients in research are discussed. In both studies, the applicants shared their interests in being involved in research. However, in Study 2, many of the patients shared ideas that were not appropriate for the development of a PRO, which indicated limitations in how the invitation and application explained the project to patients. Future studies should contribute to determining the most appropriate method for involving patients in various settings.