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Purpose: Despite a known risk of cellulitis recurrence, the management of the wider impact and risk factors has been neglected. The innovative National Cellulitis Improvement Programme (NCIP) addresses this by providing evidence-based and individualised care to improve patient reported outcomes and reduce the risk of recurrence. The aim of this paper is to examine the longer-term impact of cellulitis and to identify a suitable and clinically relevant Patient Reported Outcome Measure (PROM). Methods: A review of existing cellulitis-specific PROMs was undertaken, alongside literature detailing the patient-focused impact of cellulitis, to identify a suitable PROM for clinical use. A group of expert therapists and patient representatives (n = 14) shared their individual and collective experiences over a series of events to discuss and debate the impact of cellulitis and review available PROMs. CELLUPROM© is introduced with anonymised PROM data and case study information reported to establish the impact of CELLUPROM© within usual NCIP care. Results: No cellulitis-specific PROMs were identified. Literature focused on the signs and symptoms of an acute episode of cellulitis, with outcome measures primarily used to evidence the impact of an intervention. An enduring physical, social and emotional impact of cellulitis was identified in this study, providing the basis for the new cellulitis-specific PROM (CELLUPROM©), which has been implemented with good effect in clinical care. Conclusion: This study has highlighted the lasting impact of cellulitis. Using CELLUPROM© within the risk-reduction NCIP has helped develop Value-Based Healthcare and support programme evaluation. [ABSTRACT FROM AUTHOR]

Objectives: Bowel urgency is an impactful core symptom of ulcerative colitis (UC). Patient-reported outcome (PRO) questionnaires have been developed and used to assess the patient experience of this important symptom. The objective of this paper is to present evidence from qualitative research conducted to support the use and interpretation of select PRO questionnaires to assess bowel urgency related to the UC patient experience. Methods: Qualitative interviews were conducted with ten adults with a clinician-confirmed diagnosis of moderately to severely active UC. Interviews aimed to document patient interpretation of modified recall periods for the Urgency Numeric Rating Scale (Urgency NRS), two global assessments (i.e., the Patient Global Impression of Severity [PGIS] and Patient Global Impression of Change [PGIC]), and four items (Items 11, 16, 23, and 26) of the Inflammatory Bowel Disease Questionnaire (IBDQ), and explore the patient perspective of meaningful change on these questionnaires. Results: Both modified Urgency NRS versions (with 7-day or 3-day recall period) were interpreted as intended by most patients (≥ 88.9%), and slightly more than half of patients (60.0%) reported that the 7-day recall period was more relevant to their bowel urgency experience. Patients reported thinking of bowel urgency (≥ 80.0%) or bowel urgency-related accidents (70.0% of patients) when interpreting the global assessments and IBDQ items. Most patients reported a 1- to 3-point change as the smallest meaningful improvement that would be meaningful on the Urgency NRS (similar to findings on other questionnaires). Conclusion: Adults with UC can understand and respond to the Urgency NRS with modified recall periods (i.e., 7-day or 3-day), interpret the conceptual content of the PGIS, PGIC, and select IBDQ items to be inclusive of bowel urgency and bowel urgency-related accidents, and select answers representing meaningful improvements on the Urgency NRS, PGIS, PGIC, and IBDQ item response scales. These results further contribute patient-centered data to existing UC and bowel urgency research. [ABSTRACT FROM AUTHOR]

Background: The use of patient-reported outcome measures (PROM) and patient-reported experience measures (PREM) provide health providers with valuable feedback on how to improve clinical care and patient outcomes. This paper describes a qualitative study that was conducted to learn about factors influencing the well-being of people living with HIV (PLHIV) in Finland. The findings will be used to develop themes for HIV-specific PROM and PREM questions. Methods: PROMs and PREMs were developed by the Finnish Institute for Health (THL) as a part of a project to develop a national quality-of-care registry for HIV. The study aimed to identify issues and concerns among people living with HIV (PLHIV) that influence their well-being (PROMs) and their experiences in the healthcare system (PREMs). The data were collected through face-to-face in-depth interviews and focus group discussions based on open-ended and semi-structured questions. The data were analyzed using thematic analysis. Results: The assessment identified the following PROMs of concern: psychological well-being, concerns about stigma, physical health, social well-being, sexual well-being, medication uptake, managing other medications with antiretrovirals (ARVs), and growing old. The assessment identified the following PREMs: helping patients understand their own health status, proving an opportunity for patients to discuss physical health, psychological and sexual well-being, supporting the uptake of ARVs, assisting patients with medication use, showing compassion towards patients, and empowering patients against stigma. Conclusion: These findings of the study can be used to develop domain-specific PROM and PREM questions for the national HIV quality care register. [ABSTRACT FROM AUTHOR]

The increasing need for mental health support and a shortage of therapists have led to the development of the eXtended-reality Artificial Intelligence Assistant (XAIA). This platform combines spatial computing, virtual reality (VR), and artificial intelligence (AI) to provide immersive mental health support. Utilizing GPT-4 for AI-driven therapy, XAIA engaged participants with mild-to-moderate anxiety or depression in biophilic VR environments. Speaking with an AI therapy avatar in VR was considered acceptable, helpful, and safe, with participants observed to engage genuinely with the program. However, some still favored human interaction and identified shortcomings with using a digital VR therapist. The study provides initial evidence of the acceptability and safety of AI psychotherapy via spatial computing, warranting further research on technical enhancements and clinical impact. [ABSTRACT FROM AUTHOR]

Background: Presbyopia is a progressive condition that reduces the eye's ability to focus on near objects with increasing age. After a systematic literature review identified no existing presbyopia-specific patient-reported outcome (PRO) instruments meeting regulatory guidance, a new PRO instrument, the Near Vision Presbyopia Task-based Questionnaire (NVPTQ), was developed. Results: To explore the patient experience with presbyopia, concept elicitation interviews were conducted with 20 presbyopic participants. The most frequently reported impacts were difficulty with reading menus/books/newspapers/magazines, reading on a cell phone/caller ID, and reading small print. Based on these results, a task-based PRO instrument (the NVPTQ) was developed instructing participants to complete four near-vision, paper-based reading tasks (book, newspaper, nutrition label, menu) under standardized settings, and subsequently assess their vision-related reading ability and associated satisfaction. The draft NVPTQ was cognitively debriefed with a sample of 20 presbyopes, which demonstrated that most participants interpreted the items as intended and endorsed the relevance of the concepts being assessed. After the qualitative research, the draft instrument was psychometrically tested using data from a Phase 2 study. Based on item-level analyses, all items in the NVPTQ demonstrated expected response option patterns and lacked substantial floor or ceiling effects. The reliability, validity, and responsiveness of the NVPTQ Performance and Satisfaction domain scores were assessed. All domains scores had large Cronbach's coefficient α values and good test–retest statistics, indicating that the scores are internally consistent and produce stable values over time. The pattern of correlations with a concurrent measure of visual functioning (National Eye Institute Visual Function Questionnaire 25) demonstrated that the NVPTQ domain scores were related to an alternative assessment of near-vision activities. The NVPTQ domain scores were able to distinguish between groups that were known to differ on the clinical outcome of uncorrected near visual acuity, supporting the construct validity of these scores. The NVPTQ domain scores showed evidence of responsiveness to change by being able to distinguish between groups defined as improved and not improved based on patient-reported and clinical outcomes. Conclusions: This research has resulted in a content-valid and psychometrically sound instrument designed to evaluate vision-related reading ability and satisfaction with vision-related reading ability. Trial registration: ClinicalTrials.gov NCT02780115. Registered 23 May 2016, https://www.clinicaltrials.gov/ct2/show/NCT02780115?term=NCT02780115&draw=2&rank=1. [ABSTRACT FROM AUTHOR]

Background: Hypertension is the most prevalent risk factor for cardiovascular disease globally. Roughly one-third of the adult population has hypertension. However, most people diagnosed with hypertension do not benefit from blood pressure control with pharmacologic interventions: they are overdiagnosed and overtreated and might experience negative psychosocial consequences of being labelled. These consequences are relevant outcomes that need to be assessed and validly measured to identify all benefits and harms related to interventions designed to prevent cardiovascular disease. Objectives: To develop a pool of items with high content validity for a draft version of a condition-specific questionnaire to measure the psychosocial consequences of being labelled with mild hypertension. Methods: We selected relevant items from existing Consequences of Screening (COS) questionnaires. These items belonged to two groups: COS core items and potential condition-specific items. All items were originally in Danish and were translated into Brazilian Portuguese using the dual-panel method. Individual and group interviews were conducted with people with mild hypertension and low risk for cardiovascular disease, and were designed to test the translated items for face and content validity and were also used to generate new relevant items. Structured individual interviews were conducted to categorise all the items into domains. Results: The Brazilian Portuguese dual-panel translation of both groups of items was found to be relevant for adults diagnosed with hypertension. We generated 52 new items to achieve high content validity. The result was a set of 132 items divided into 22 domains in 2 parts. Part I was directed at the general population, whereas part II was directed only at people diagnosed with hypertension and it consisted of 38 items in 8 domains. Twelve items remained as single items. High content validity was achieved with the pool of 132 items divided into 22 domains in 2 parts. Discussion: High content validity was achieved for a condition-specific questionnaire measuring the psychosocial consequences of being labelled with mild hypertension. This instrument encompassed 132 items divided into 22 domains in 2 parts. Thereby, a draft of the Consequneces of Hypertension questionnaire (COH) was developed. The psychometric properties of this questionnaire will be discussed in a diferent paper. [ABSTRACT FROM AUTHOR]

Self-completed questionnaires (usually distributed by post) and visual analogue scales (VAS) are common means for collecting valuations for hypothetical EQ-5D health states. Although opportunities for respondents to comment on aspects of the exercise are often included, these data have rarely been the focus of analyses. This paper, therefore, reports on solicited and unsolicited written comments received in a New Zealand survey in 1999 to which 1360 people responded of whom approximately 50% made comments. The comments were systematically analysed via an inductive process that allowed principal themes to emerge with respect to understanding the peculiarities of respondents' valuations, particularly common 'data problems', and their perceptions as to the adequacy or otherwise of the EQ-5D classification system. From our findings we conclude that the valuation exercise imposes a substantial cognitive burden on respondents and many do not understand it (for a variety of reasons documented in the paper). Also, although there is some evidence for expanding the EQ-5D (generic) health-related quality of life dimensions, more research as to whether this holds for a larger sample and across cultural settings is needed. We offer recommendations for future research into understanding respondents' cognitive processes and possible revisions to the design and administration of the EQ-5D. [ABSTRACT FROM AUTHOR]

Introduction: The EQ Health and Wellbeing (EQ-HWB) is a new questionnaire for measuring quality of life (QoL) from a broad perspective. The items of the EQ-HWB were derived based on a 'qualitative review' of literature, which reported primarily on Western studies. It can be argued that the QoL is a cultural-related concept and therefore people from China have a different understanding of the QoL. This study aimed to explore whether Chinese citizens could understand the EQ-HWB's candidate items and what they thought of those items. In doing so, we wanted to examine the face validity of the candidate items and explore if further cultural adaptation is necessary. Methods: This research was part of the E-QALY project, in which 36 candidate items were selected for the EQ-HWB from a 97-item pool. In China, three interviewers investigated the face validity of these EQ-HWB candidate items in semi-structured qualitative face-to-face interviews. Respondents were invited to report 'problems' with regard to the interpretation of the items and these problems were grouped into themes. We explored to what extent those themes related to specific cultural aspects in China. We also classified the rates of reported problems for each item into three groups: 1) less than 20%, 2) from 20–50%, and 3) over 50%. Results: For 17 items the rate of reported problems was less than 20%, 15 items fell into the second group (with 20 − 50%) and for 4 items the rate of problems reported was more than 50%. The thematic analysis revealed eight themes: ambiguous problems in the interpretation of 16 items; difficult to understand (11); contained a complex negative expression (10); examples used seemed inappropriate (7); misleading connotation in Chinese (2); long and complex (2); complex response options (1); and use of non-colloquial language (1). Discussion: Our research shows that EQ-HWB candidate items require careful examination to make them more comprehensible. Most of the reported problem themes were generic problems related to the items, and only a few face validity issues appeared to relate to specific cultural aspects in China, even though most of the items were based on Western studies. Our findings are reassuring for the instrument's international application, especially in China. [ABSTRACT FROM AUTHOR]

Background: Psychometric theory offers a range of tests that can be used as supportive evidence of both validity and reliability of instruments aimed at measuring patient-reported outcomes (PRO). The aim of this paper is to illustrate psychometric tests within the Classical Test Theory (CTT) framework, comprising indices that are frequently applied to assess item- and scale-level psychometric properties of PRO instruments. Methods: Using data on the PROMIS Depression Item Bank, typical CTT indices for the assessment of psychometric properties are illustrated, including content validity, item-level data exploration, reliability, and construct validity, particularly confirmatory factor analysis, to test the unidimensionality assumption underlying the item bank. Analyses are carried out on an original item set of 51 depression items, the final (official) PROMIS Depression Item Bank consisting of 28 items, and an 8-item short form. Results: The analyses reported provide an informative illustration on how item- and scale-level reliability and validity statistics can be used to assess the psychometric quality of a PRO instrument. The results illustrate how the reported statistics can be used for item selection from an item pool (here: 51 items). Both the (final) 28-item bank and the 8-item short form show good psychometric properties supporting the high quality of individual items and the unidimensionality assumption of the item bank. Conclusions: It is our hope that our illustration of CTT methods, in conjunction with two companion papers illustrating modern test theory methods, will help researchers to confidently apply a range of statistical tests to evaluate item- and scale-level psychometric performance of PRO instruments. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QoL) is an important determinant of physical and mental health. QoL in head and neck cancer tends to deteriorate due to changes in the physical, functional, psychological aspects. EORTC-QLQ-H&N35 is an instrument that measure the QoL specifically in head and neck cancer patients. EORTC-QLQ-H&N35 give a numeric value to QoL of patients with high value correspond to better QoL. Objective: The aim of present study was to find out the cut-off points of numeric values of EORTC-QLQ-H&N35 to categorize QoL impairment into different categories (normal, mild, moderate, and severe). Present study also aims analyze the QoL among head and neck cancer patients under these new categories. Methodology: Total 205 patients of head and neck cancer visiting to the outpatient unit were enrolled in this study. Hindi version of EORTC-QLQ-H&N35 was used to evaluate the QoL. Total 9 classification schemes were created with different cut-off points to classify the global QoL score into normal, mild, moderate and severe categories. QoL data was then analyze using the scheme having highest F value in ANOVA test. Results: Classification scheme having cut-off values 76–100 for normal QoL, 51–75 for mild QoL impairment, 26–50 for moderate and 0–25 for severe QoL impairment found to have highest F value (729.915) in ANOVA test. The mean QoL score among total 205 patients were 60.08 ± 19.06. Based on the new classification scheme, QoL was normal in 46 (22.4%) patients whereas QoL was impaired to mild level in 76 (37.1%) patients, to moderate level in 76 (37.1%) and to severe level in 7 (3.4%) patients. Role functioning, emotional functioning and social functioning was impaired to severe level in 4 (2.0%), 13 (6.3%) and 3 (1.5%) patients respectively. Conclusion: EORTC-QLQ-H&N35 offer a comprehensive review of QoL in head and neck cancer patients. By designating the QoL score into different categories, it will become easier for clinician to have a better idea of QoL of head and neck cancer patients. [ABSTRACT FROM AUTHOR]

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Background: SMA is a hereditary neuromuscular disease that causes progressive muscle weakness and atrophy. Several studies have shown that the burden of SMA is very high at many levels. Functional assessment tools currently used do not completely address the impact of the disease in patients' life. The objective of this qualitative study was to identify aspects of SMA that are relevant to patients and to design items useful for assessment purposes. Results: Five focus group sessions were run during an annual SMA families meeting in Madrid, Spain. Focus groups were composed by parents of SMA type I children, sitter children type II-III, parents of sitter children type II-III, adult patients, and parents of walker children. Two trained facilitators conducted the focus groups using a semi-structured guideline to cover previously agreed topics based on the input of a Scientific and Patient Advisory Committee. The guideline was adapted for the different groups. According to what was communicated by participants, SMA entails a high burden of disease for both patients and their parents. Burden was perceived in physical, psychological, and social areas. Patient's physical domain was the most relevant for participants, especially for parents of non-ambulant children, followed by limitations of motor scales to capture all changes, parents psychological burden, treatment expectations and patient's psychological burden. Ten domains were the main areas identified as impacted by the disease: mobility and independence, fatigue and fatigability, infections and hospital consultations, scoliosis and contractures, vulnerability, pain, feeding, time spent in care, breathing, and sleep and rest. Conclusions: This study confirms the necessity of evaluating other aspects of the disease that are not assessed in the functional motor scale. Measures of other aspects of the disease, such as pain, fatigue, feeding, should be also considered. A patient-reported outcomes instrument measuring such aspects in a valid and reliable way would be very useful. This study generated a list of new items relevant to be systematically measured in the assessment of the impact of SMA on the patients' everyday life. [ABSTRACT FROM AUTHOR]

Background: Rheumatoid arthritis (RA) is a systemic autoimmune chronic inflammatory disease, causing progressive disability. Methotrexate (MTX) is the gold standard drug treatment for RA. Long-term use of MTX is associated with intolerance including gastrointestinal effects. In addition, anticipatory, associative, and behavioral symptoms such as anxiety and irritability are also observed which are often inadequately managed, leading to discontinuation of treatment. Methotrexate Intolerance Severity Score (MISS) questionnaire designed to measure MTX intolerance. The work aims to validate the MISS questionnaire Arabic version for the detection of MTX intolerance among Egyptian RA patients to halt the progression of the disease. Results: A total of 80 patients were involved in this study. Of those, 67 (83.8%) were females with a mean disease duration of 6.9 ± 6.1 years. Forty-eight patients (60%) were intolerant to MTX and 32 patients (40%) were tolerant. Comparison between the tolerant group (n = 32) to MTX and the intolerant group (n = 48) revealed a statistically significant difference between them regarding the DAS28 score and HAQ score. Behavioral intolerance is the predominant factor that directs MTX intolerance. Conclusion: The MISS questionnaire has a good predictive ability to detect MTX intolerance among Egyptian RA patients. Due to its good reliability, serves as an invaluable tool as it detects anticipatory and associative symptoms. [ABSTRACT FROM AUTHOR]

Background: The Brief Pain Inventory-short form (BPI-sf) is widely used in self-reported pain assessment, incorporates pain numeric rating scales (NRS) and is commonly utilized in electronic format in clinical trials, however, there is no published information about its usability as an electronic patient-reported outcome (ePRO) measure. The objective of this qualitative study was threefold: 1) to better understand pain experiences among patients with pleural or peritoneal mesothelioma; 2) to assess the interpretability of the instructions, item stem, recall period, and response option of the "worst pain" item of the BPI-sf; and 3) to examine the usability of the TrialMax Touch™ (CRF Health, Inc., Plymouth Meeting, PA) screen-based handheld device and the electronic format of the BPI-sf in a sub-sample of pleural mesothelioma patients. Methods: A cross-sectional qualitative study was conducted among participants with pleural and peritoneal mesothelioma recruited from 4 clinical sites in the US. Semi-structured telephone or in-person interviews were conducted consisting of concept elicitation, cognitive interviewing of the 11-item BPI-sf, and in-person interview evaluation of ePRO assessment usability in pleural mesothelioma patients. Results: Twenty-one participants recruited from 4 clinical sites in the US were interviewed in-person (n = 9) and by telephone (n = 12); 71% male; mean age 68.7 ± 13.6 years. Pleural and peritoneal patients described pain as ranging from discomfort to intense pain and reported being able to distinguish tumor pain from treatment pain. The BPI-sf "worst pain" item was relevant to, and easily understood by, study participants with pleural and peritoneal mesothelioma. The ePRO version was found to be easy to use, but readability of small font may be an issue. Participants reported minimal differences between their responses on the paper and ePRO version for all of the pain severity and pain interference items. Conclusions: Results support the relevance and ease of understanding of the "worst pain" item and provide support for its content validity in patients with pleural and peritoneal mesothelioma. Usability of the ePRO format of the BPI-sf was confirmed for use in clinical trials among patients with pleural mesothelioma. [ABSTRACT FROM AUTHOR]

Background: This study evaluated the content validity and psychometric properties of the Patient-Reported Outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) v1.0 scale to determine its suitability in clinical trials to assess fatigue in patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC). Methods: A qualitative interview assessed patients' experience living with CD (N = 20) and UC (N = 19). The contents of the SF-7a scale were cognitively debriefed to evaluate content validity. A psychometric evaluation was performed using data from clinical trials of patients with CD (N = 360) and UC (N = 214). Correlations with Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Activity Index (CDAI; CD only), and Mayo score (UC only) determined validity. The Patient Global Impression of Change (PGIC) was used to evaluate reliability and responsiveness to change. Using PGIC as an anchor, a preliminary threshold for clinically meaningful change was identified to define fatigue response in both CD and UC patients. Results: All patients reported fatigue as a common symptom. Patients confirmed SF-7a items were relevant to assessing fatigue, instructions and response options were clear, and its 7-day recall period was appropriate. Higher SF-7a scores were associated with higher disease activity (CDAI and Mayo score) and lower health-related quality of life (IBDQ), confirming known groups validity. The correlation of the SF-7a scale was higher with fatigue-related items. (rs ≥ -0.70) than with items not directly associated with fatigue. Test-retest reliability was moderate to good (0.54–0.89) among patients with stable disease, and responsiveness to change in disease severity was demonstrated from baseline to Week 12. A ≥7point decrease was identified as a reasonable threshold to define clinically meaningful improvement. Conclusion: The SF-7a scale is a valid, reliable, and sensitive measure of fatigue in patients with moderately to severely active IBD and can be used to evaluate treatment response. [ABSTRACT FROM AUTHOR]

Background: The vaccine industry is one of the most important health-related industries. It can be affected by accession to the World Trade Organization (WTO) because of probable dramatic changes in the business environment. Iran has already initiated accession negotiations. Purpose of the study: In this paper, we investigate the position of, challenges to, and opportunities for vaccine manufacturing in Iran with regard to accession to the WTO. Methods: This is a qualitative and cross sectional study. To collect information, we designed a questionnaire and interviewed some of the vaccine industry's key opinion leaders in Iran. Before the interviews were conducted, the questionnaires were sent to these individuals by email. Results: According to the interviewees, the country's main challenges with regard to accession to the WTO are the lack of firm internal intellectual property (IP) rules, not being recognized as pre-qualified by the World Health Organization (WHO), the use of old equipment, and a lack of cooperation with global vaccine companies. Major conclusions: Iran's local vaccine industry, with a long history and international reputation that could be used as an advantage, is faced with several challenges, such as problems with keeping up with Current Good Manufacturing Practice (cGMP), a lack of adequate and meaningful investment in research and development (R&D), and limitations on private sector participation in the production of vaccines. Gradual privatization of the industry, improved international relations, utilization of the R&D power of small hi-tech companies, consistent education of human resources, and modernization of infrastructures and equipment are among the suggested solutions. [ABSTRACT FROM AUTHOR]

Home country re-entry from cross-cultural missionary work abroad may be associated with psychological distress. Re-entrants experience multiple losses including loss of identity which may be associated with personal/relational identity gaps and depersonalization/dehumanization. However, research suggests that some re-entrants are resilient with good mental health, while others are fragile with poor mental health. The aims of this paper are to explore the nature and frequency of re-entering missionaries' identity gaps and their depersonalization/dehumanization in resilient and fragile re-entrants. Fifteen re-entering adult Australian cross-cultural missionary workers from four interdenominational Australian mission organizations completed semi-structured interviews. Results were analysed using modified Consensual Qualitative Research methods. Links were established between personal/relational identity gaps, depersonalization/dehumanization and resilience on re-entry. Implications for re-entrants' care are discussed with suggestions for further research. [ABSTRACT FROM AUTHOR]

Purpose: To produce a culturally adapted translation of the Rapid Assessment of Physical Activity (RAPA) questionnaire for German speaking Austrians and to conduct a linguistic validation of the new language version. Methods: The original English RAPA questionnaire was translated into German for Austria and underwent an independent forward and back translation, followed by cognitive debriefing interviews with older adults aged 55 to 78 years with and without health conditions (n = 13), for linguistic validation. Results: Several distinct choices were made in the translation of the RAPA questionnaire to German, including the use of colloquial terms for 'physical activity' and 'intensity'; and the decision to keep to the original examples and images of different physical activities for illustrating the intensity levels (light, moderate, vigorous) of physical activity. In cognitive debriefing, interviewees commented that some example activities for the respective intensity levels could – depending on the individual – also represent a higher or lower intensity level; and that the wording of RAPA items 4 and 5, which describe the category 'under-active regular' aerobic activity, was difficult to understand. Both issues were addressed and resolved through minor iterative modifications made during the cognitive debriefing process. Conclusions: A new version of the RAPA questionnaire in German for Austria has been produced by forward and back translation and linguistic validation. The questionnaire may now undergo psychometric evaluation. [ABSTRACT FROM AUTHOR]

Background: Exercise therapy is considered effective for the treatment of motor impairment in patients with Parkinson's disease (PD). During the COVID-19 pandemic, training sessions were cancelled and the implementation of telerehabilitation concepts became a promising solution. The aim of this controlled interventional feasibility study was to evaluate the long-term acceptance and to explore initial effectiveness of a digital, home-based, high-frequency exercise program for PD patients. Training effects were assessed using patient-reported outcome measures combined with sensor-based and clinical scores. Methods: 16 PD patients (smartphone group, SG) completed a home-based, individualized training program over 6–8 months using a smartphone app, remotely supervised by a therapist, and tailored to the patient's motor impairments and capacity. A control group (CG, n = 16) received medical treatment without participating in digital exercise training. The usability of the app was validated using System Usability Scale (SUS) and User Version of the Mobile Application Rating Scale (uMARS). Outcome measures included among others Unified Parkinson Disease Rating Scale, part III (UPDRS-III), sensor-based gait parameters derived from standardized gait tests, Parkinson's Disease Questionnaire (PDQ-39), and patient-defined motor activities of daily life (M-ADL). Results: Exercise frequency of 74.5% demonstrated high adherence in this cohort. The application obtained 84% in SUS and more than 3.5/5 points in each subcategory of uMARS, indicating excellent usability. The individually assessed additional benefit showed at least 6 out of 10 points (Mean = 8.2 ± 1.3). From a clinical perspective, patient-defined M-ADL improved for 10 out of 16 patients by 15.5% after the training period. The results of the UPDRS-III remained stable in the SG while worsening in the CG by 3.1 points (24%). The PDQ-39 score worsened over 6–8 months by 83% (SG) and 59% (CG) but the subsection mobility showed a smaller decline in the SG (3%) compared to the CG (77%) without reaching significance level for all outcomes. Sensor-based gait parameters remained constant in both groups. Conclusions: Long-term training over 6–8 months with the app is considered feasible and acceptable, representing a cost-effective, individualized approach to complement dopaminergic treatment. This study indicates that personalized, digital, high-frequency training leads to benefits in motor sections of ADL and Quality of Life. [ABSTRACT FROM AUTHOR]

Background: Pediatric asthma has been identified by regulators, clinicians, clinical trial sponsors, and caregivers as an area in need of novel fit-for-purpose clinical outcome assessments (COAs) developed in accordance with the U.S. Food and Drug Administration's (FDA's) regulatory guidance for evaluating clinical benefit in treatment trials. To address this gap, the Patient-Reported Outcome (PRO) Consortium's Pediatric Asthma Working Group has continued development of 2 COAs to assess asthma signs and symptoms in pediatric asthma clinical trials to support efficacy endpoints: a PRO measure, the Pediatric Asthma Diary—Child (PAD-C) for children 8–11 years old (y.o.) and an observer-reported outcome measure, the Pediatric Asthma Diary-Observer (PAD—O) for caregivers of children 4–11 y.o. This qualitative research aimed to generate evidence regarding the content validity of the PAD-C and PAD-O. Methods: Semi-structured combined concept elicitation and cognitive interviews were conducted with a diverse sample of U.S. participants (15 children 8–11 y.o. and 30 caregivers of children 4–11 y.o.). All children had clinician-diagnosed mild to severe asthma. Interviews explored the experience of pediatric asthma and assessed the understanding and relevance of both measures. Interviews were conducted across 3 iterative rounds to allow for modifications. Results: Concept elicitation findings demonstrated that the core sign/symptom and impact concepts assessed in the PAD-C (cough, hard to breathe, out of breath, wheezing, chest tightness, and nighttime awakenings/symptoms) and PAD-O (cough, difficulty breathing, short of breath, wheezing, and nighttime awakenings/signs) correspond to those most frequently reported by participants; concept saturation was achieved. All PAD-C and PAD-O instructions and core items were well understood and considered relevant by most participants. Feedback from participants, the Pediatric Asthma Working Group, advisory panel, and FDA supported modifications to the measures, including addition of 1 new item to both measures and removal of 1 caregiver item. Conclusions: Findings provide strong support for the content validity of both measures. The cross-sectional measurement properties of both measures and their user experience and feasibility in electronic format will be assessed in a future quantitative pilot study with qualitative exit interviews, intended to support the reliability, construct validity, final content, and, ultimately, FDA qualification of the measures. Plain English summary: Pediatric asthma is one of the most common chronic diseases in children. However, there are problems of underdiagnosis, poor disease management, and undertreatment for many pediatric asthma patients, pressuring healthcare systems worldwide. Evaluating asthma symptoms is an important part of the development of treatments for pediatric asthma. However, there are few clinical outcome assessments (COAs) developed in line with regulatory guidance to directly assess symptom severity and evaluate the benefit of new treatments in children with asthma. In this study, we continued the development of the Pediatric Asthma Diary—Child (PAD-C) and the Pediatric Asthma Diary—Observer (PAD-O), according to regulatory guidance, to assess asthma signs and symptoms in children 4 through 11 years old and address this unmet need. The study aimed to explore the experience of pediatric asthma and assess how well-understood and relevant the measures are. Three rounds of qualitative interviews were conducted with 15 children 8 through 11 years old and 30 caregivers of children 4 through 11 years old with asthma. Results show that both measures are well-understood and assess the relevant and important aspects of pediatric asthma reported by children and caregivers. Findings provide evidence supporting the PAD-C and PAD-O as measures of symptom severity and their future use in pediatric asthma treatment trials. Further research is underway to evaluate their measurement properties and assess the user experience and feasibility of electronic completion, to ultimately support the PAD-C and PAD-O in an ongoing COA qualification process by the United States Food and Drug Administration. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) provide a measure of self-perceived health status or health-related quality of life. They have been used to support provider-patient decisions, healthcare delivery, and value-based healthcare models. A barrier to routine collection of PROMs is the perception that PROMs lack clinical utility. As such, it is important to establish clinicians' acceptability of the PROM prior to large-scale implementation. This study explored the acceptability of the routine use and collection of a generic PROM in healthcare services from the perspective of healthcare staff. Methods: Individual semi-structured interviews were completed from September 2020 to March 2021 with 26 staff from two multi-disciplinary community healthcare services in Melbourne, Australia. Interviews explored their experiences of using the EQ-5D-5L in their routine care. Interviews were recorded and transcribed verbatim. Data were analysed according to a framework approach, using inductive and deductive techniques. Results: Participants discussed the acceptability of the EQ-5D-5L with reference to four themes: practicalities of use; holistic nature; influence on client care; and influence on health service. Participants found the EQ-5D-5L quick and easy to administer, and appreciated that it measured multiple domains of health that were relevant to their clients' care. They believed the EQ-5D-5L helped to identify client problems, and inform service delivery. They also reported features that were less acceptable, including a lack of item specificity to some healthcare disciplines. Participants reported the challenge of managing conflict between their assessment of the client's health and the client's perspective of their own health, leading some to question whether the client could provide an accurate reflection of their own health. Conclusions: The EQ-5D-5L has several features that healthcare staff viewed as acceptable for routine collection and use in healthcare. Training on the validity of the patient reported perspective and broadening the scope of PROMs collection beyond the EQ-5D-5L should be considered to facilitate large-scale implementation. [ABSTRACT FROM AUTHOR]

Background: Within pediatric health care services, Patient-reported Outcomes (PROs) regarding the patient's health status are mainly used for research purposes in a chronic care setting. However, PROs are also applied in clinical settings in the routine care of children and adolescents with chronic health conditions. PROs have the potential to involve patients because they 'place the patient at the center' of his or her treatment. The investigation of how PROs are used in the treatment of children and adolescents and how this use can influence the involvement of these patients is still limited. The aim of this study was to investigate how children and adolescents with type 1 diabetes (T1D) experience the use of PROs in their treatment with a focus on the experience of involvement. Results: Employing Interpretive Description, 20 semi-structured interviews were conducted with children and adolescents with T1D. The analysis revealed four themes related to the use of PROs: Making room for conversation, Applying PROs under the right circumstances, Questionnaire structure and content, and Becoming partners in health care. Conclusions: The results clarify that, to some extent, PROs fulfill the potential they promise, including patient-centered communication, detection of unrecognized problems, a strengthened patient-clinician (and parent-clinician) partnership, and increased patient self-reflection. However, adjustments and improvements are needed if the potential of PROs is to be fully achieved in the treatment of children and adolescents. [ABSTRACT FROM AUTHOR]

Background: To capture the broad range of treatment burden issues experienced by adolescent and adult people with hemophilia (PWH), the Hemophilia Treatment Experience Measure (Hemo-TEM) was developed. We describe the development of this new hemophilia-specific patient-reported outcome (PRO) measure including concept elicitation, cognitive debriefing, and psychometric validation. Results: Concept elicitation interviews were conducted with 5 clinical experts and 30 adult PWH in the United States (US). The qualitative analysis of these interviews and a review of the literature informed the PRO measure development. The project team reviewed concept endorsement rates and generated a 27-item preliminary version of the Hemo-TEM. Cognitive debriefing interviews were conducted to ensure participant understanding and item relevance in samples of (adolescent (n = 20) and adult (n = 14)) PWH in the US. The refined, validation-ready version of the Hemo-TEM included 30 items. Lastly, data from 3 clinical trials comprised the 4 analysis sets used for the psychometric validation with a sample size of N = 88. Item reduction dropped 4 items resulting in a final 26-item measure. Factor analysis generated 5 domains in the Hemo-TEM [injection difficulties (3 items), physical impact (6 items), treatment bother (7 items), interference with daily life (4 items), and emotional impact (6 items)] and a total score. All scores were reliable [internally consistent (0.84–0.88)]. For convergent validity, with the exception of one domain, all hypothesized associations were met. Preliminary sensitivity to change effect sizes were between − 0.30 and − 0.70. Meaningful change thresholds ranged from 6 points (physical impact and emotional impact) to 10 points (treatment bother) with 8 points for the Hemo-TEM total score. Conclusions: Findings from the concept elicitation, cognitive debriefing, and psychometric validation phases provide evidence that the Hemo-TEM is a well-designed, valid, and reliable measure of the burden of hemophilia treatment, including treatment impact on adolescent and adult PWH. [ABSTRACT FROM AUTHOR]

Background: To examine the acceptability of a Patient Reported Outcome Measure (PROM) that assesses perceptions and experiences of implants for breast reconstruction or augmentation, and the feasibility of implementing it in the Australian Breast Device Registry (ABDR). Methods: The BREAST-Q Implant Surveillance (BREAST-Q IS) is a 5-question PROM derived from the BREAST-Q questionnaire. It assesses perceptions of breast appearance and sensation, and experiences of pain. Breast implant recipients (recruited via community networks, social media and notices in surgeons' rooms) and surgeons contributing to the ABDR were invited to review the BREAST-Q-IS. Participation was by individual semi-structured interviews by telephone or email, or by completion of a paper questionnaire. Transcripts of audio recordings and emailed text were analysed thematically. Results: Twenty one breast implant recipients (10 after reconstruction and 11 augmentation), 8 surgeons (five plastic, three breast) and 2 medical professionals performing cosmetic surgeries were interviewed. Six themes were identified: Overall impression, Emotional response to the BREAST-Q IS, Method of follow-up, Suggested improvements, Group variation, and Potential Clinical utility. Overall, breast implant recipients and surgeons found the BREAST-Q IS to be acceptable and unlikely to provoke strong emotional reactions. Email was the preferred mode of contact. Most suggested improvements were to add questions. Surgeons expressed concern that subjective responses to the PROM might not accurately reflect experiences and that the PROM would predict need for revision rather than device failure. Conclusion: This study supports the acceptability and feasibility of BREAST-Q IS as a PROM for recipients of breast implants. Further validation of the Breast-Q IS is required. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: A glaucoma-specific health-related quality of life (HRQoL) item bank (IB) and computerized adaptive testing (CAT) system relevant to Asian populations is not currently available. We aimed to develop content for an IB focusing on HRQoL domains important to Asian people with glaucoma; and to compare the content coverage of our new instrument with established glaucoma-specific instruments. Methods: In this qualitative study of glaucoma patients recruited from the Singapore National Eye Centre (November 2018-November 2019), items/domains were generated from: (1) glaucoma-specific questionnaires; (2) published articles; (3) focus groups/semi-structured interviews with glaucoma patients (n = 27); and (4) feedback from glaucoma experts. Data were analyzed using the constant comparative method. Items were systematically refined to a concise set, and pre-tested using cognitive interviews with 27 additional glaucoma patients. Results: Of the 54 patients (mean ± standard deviation [SD] age 66.9 ± 9.8; 53.7% male), 67 (62.0%), 30 (27.8%), and 11 (10.2%) eyes had primary open angle glaucoma, angle closure glaucoma, and no glaucoma respectively. Eighteen (33.3%), 11 (20.4%), 8 (14.8%), 12 (22.2%), and 5 (9.3%) patients had no, mild, moderate, severe, or advanced/end-stage glaucoma (better eye), respectively. Initially, 311 items within nine HRQoL domains were identified: Visual Symptoms, Ocular Comfort Symptoms, Activity Limitation, Driving, Lighting, Mobility, Psychosocial, Glaucoma management, and Work; however, Driving and Visual Symptoms were subsequently removed during the refinement process. During cognitive interviews, 12, 23 and 10 items were added, dropped and modified, respectively. Conclusion: Following a rigorous process, we developed a 221-item, 7-domain Asian glaucoma-specific IB. Once operationalised using CAT, this new instrument will enable precise, rapid, and comprehensive assessment of the HRQoL impact of glaucoma and associated treatment efficacy. [ABSTRACT FROM AUTHOR]

Background: Life engagement in the context of mental health is a broad term that describes positive health aspects relating to cognition, vitality, motivation and reward, and the ability to feel pleasure—concepts that are meaningful to patients. The aim of this systematic literature review was to identify validated patient-reported outcomes (PROs) that can assess any aspect of life engagement in adults, in the field of general mental health. Methods: This was a systematic literature review of articles in English from the MEDLINE database (date of search: September 9, 2020). The search strategy had three components: (1) terms to capture PROs; (2) terms to capture mental health; and (3) terms to capture aspects of life engagement. Articles were eligible if they included a PRO that: (1) is named; (2) can be used across mental health disorders; (3) is used to assess any aspect of life engagement; and (4) has undergone psychometric validation and/or qualitative content validation. A list of PROs was extracted. Results: A total of 1585 records were screened and 233 articles were eligible for inclusion. Within these 233 articles, 49 distinct PROs were identified, two of which specifically captured their authors' interpretation of life engagement: the Engaged Living Scale (ELS) and the Life Engagement Test (LET). However, while the ELS and LET covered motivation and reward, life fulfillment, and value-based living, neither scale captured the cognitive or vitality aspects of life engagement. The remaining identified PROs generally captured single aspects of life engagement, most commonly motivation/reward/energy–apathy, pleasure–anhedonia, and mental/psychological well-being. Conclusion: Numerous PROs are available that may capture aspects of life engagement. However, a need remains for a new PRO that can be used in clinical trials to provide a more comprehensive description of the improvements in life engagement that patients with mental health disorders may experience with successful treatment. [ABSTRACT FROM AUTHOR]

Background: The outlook for patients with metastatic synovial sarcoma (mSS) is poor. Better understanding of patient experience in this setting, beyond clinical measures, may guide improvements in management. Validated patient-reported outcome (PRO) instruments specific to many types of cancer exist, but for rare cancers this is often not the case. Methods: This study aimed to characterize patient experiences of symptoms and impacts of mSS and evaluate the content validity and relevance of the novel European Organization for Research and Treatment of Cancer Item Library 31 (EORTC IL31) Disease Symptoms PRO tool assessing synovial sarcoma symptoms. This tool comprises items from preexisting, validated cancer-specific PRO instruments from the EORTC Item Library. It was developed as an mSS-specific add-on to the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), which evaluates general cancer and treatment-related symptoms and functioning. This was a non-interventional, qualitative interview study involving semi-structured, concept elicitation (CE) and cognitive debriefing (CD) telephone interviews in adults with mSS. CE explored symptoms and their impact on functioning and quality of life; CD assessed participant understanding and relevance of the PRO tools. Results: Among the 8 participants, the most common disease-related symptoms reported during CE were fatigue and pain, while shortness of breath was one of the most bothersome. The greatest negative impacts of mSS occurred in domains of physical functioning and sleep. Key treatment priorities for patients were to improve disrupted sleep and ability to undertake strenuous activities. Conclusions: The interviews showed that, when used together, the EORTC IL31 and EORTC QLQ-C30 covered symptoms and impacts of most relevance and importance to patients with mSS, with no notable gaps and good conceptual coverage. This study therefore supports the content validity of 2 tools in mSS, advocating their use in clinical trials to assess treatment impact on PRO measures of importance to these patients. [ABSTRACT FROM AUTHOR]

Background: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a Patient-Reported Outcome Measure (PROM) used to evaluate the health status of patients with heart failure (HF) but has predominantly been tested in settings serving predominately white, male, and economically well-resourced populations. We sought to examine the acceptability of the shorter version of the KCCQ (KCCQ-12) among racially and ethnically diverse patients receiving care in an urban, safety-net setting. Methods: We conducted cognitive interviews with a diverse population of patients with heart failure in a safety net system to assess their perceptions of the KCCQ-12. We conducted a thematic analysis of the qualitative data then mapped themes to the Capability, Opportunity, Motivation Model of Behavior framework. Results: We interviewed 18 patients with heart failure and found that patients broadly endorsed the concepts of the KCCQ-12 with minor suggestions to improve the instrument's content and appearance. Although patients accepted the KCCQ-12, we found that the instrument did not adequately measure aspects of health care and quality of life that patients identified as being important components of managing their heart failure. Patient-important factors of heart failure management coalesced into three main themes: social support, health care environment, and mental health. Conclusions: Patients from this diverse, low-income, majority non-white population experience unique challenges and circumstances that impact their ability to manage disease. In this study, patients were receptive to the KCCQ-12 as a tool but perceived that it did not adequately capture key health components such as mental health and social relationships that deeply impact their ability to manage HF. Further study on the incorporation of social determinants of health into PROMs could make them more useful tools in evaluating and managing HF in diverse, underserved populations. [ABSTRACT FROM AUTHOR]

Introduction: Presbyopia is a progressive, age-related visual condition that is characterized by reduced ability to focus on near/close objects, causing impacts on individuals' daily function and health-related quality of life. The Presbyopia Impact and Coping Questionnaire (PICQ) is a new patient-reported outcome (PRO) instrument that assesses presbyopia impact and use of coping behaviors among presbyopic individuals. Methods: To document the impacts of presbyopia and associated coping behaviors, concept elicitation (CE) interviews were conducted with 20 presbyopic participants. Results from the CE interviews were used to develop draft items for additional testing. Following item generation, the draft PICQ was cognitively debriefed with 20 participants. Data from a phase 2 controlled clinical trial were used for psychometric analyses of the PICQ. The PICQ was administered at site visits throughout a 28-day treatment period. Confirmatory factor analysis (CFA) methods were used to guide the development of the scoring algorithm. The reliability (internal consistency, test–retest), construct validity (convergent and discriminant validity, known-groups methods), and responsiveness (Guyatt's responsiveness statistic [GRS]) of the PICQ scores were evaluated. Finally, anchor-based and distribution-based methods were used to inform thresholds for interpreting meaningful within-patient change. Results: CE interviews identified the important and relevant presbyopia-related impacts and coping behaviors and 22 items were drafted and cognitively debriefed. Following minor revisions and item addition/deletion, a version of the PICQ including 23 items was subjected to psychometric testing. The analysis sample included 151 participants. The CFA established two PICQ domain scores, Coping and Impact, on 0-to-4 scales that demonstrate good model fit (root mean square error of approximation = 0.06, comparative fit index = 0.98, Tucker-Lewis index = 0.98, standardized root mean square = 0.07). Cronbach's alphas for the Coping and Impact scores were 0.89 and 0.84, respectively. Test–retest intraclass correlation coefficients were 0.77 for Coping and 0.67 for Impact. The pattern of results assessing construct validity was acceptable for the PICQ Coping and Impact scores, with the magnitude of correlations and effect sizes generally meeting a priori expectations. The corresponding GRS effect sizes for the PICQ Coping scores were −1.23 (i.e., large) for Patient Global Impression of Change (PGIC) and −0.72 (i.e., medium) for uncorrected near visual acuity (UNVA). The GRS effect sizes for the PICQ Impact scores were −0.60 (i.e., medium) for PGIC and −0.35 (i.e., small) for UNVA. Across three sets of anchor-based analyses for interpreting individual-level change, a responder threshold of −1.00 was identified for both PICQ Coping and PICQ Impact scores. Conclusions: The totality of evidence from the qualitative and quantitative research establishes that the PICQ scores produced are valid and reliable measures of presbyopia impacts and coping behaviors that are important and relevant for assessing presbyopia treatment outcomes. ClinicalTrials.gov identifier: NCT02780115; date of registration May 19, 2016. [ABSTRACT FROM AUTHOR]

Background: Most children with autism spectrum disorder (ASD) suffer from aberrant responses to sensory stimuli that significantly impact the quality of life. To develop sensory interventions, individually tailored outcome measures are crucially needed for the domain of sensory reactivity problems. Here, we describe the identification of relevant sensory themes according to caregivers of children with ASD according to the guidelines for developing a (parent proxy) patient-reported outcome measure set. Subsequently, we identify parallels between these themes and a well-validated and supported PROMIS® portal to facilitate implementation. Interviews with clinicians and focus groups and interviews with parents of children with ASD were used in the initial phase for concept elicitation. Codes and themes were generated by qualitative thematic data analysis on the transcripts and cognitive interviews with different parents were used for revisions. The resulting themes were compared to existing generic PROMIS-item banks and other existing questionnaires. Results: A total of 11 parent-reported outcomes were identified that could be either classified as directly or indirectly related to sensory reactivity. Directly related themes comprised of: (1) sensory stimulation tolerance and (2) sensitivity to sensory stimuli. Indirectly related themes were: (3) irritable behavior (4) anxiety problems (5) mood problems (6) sleep problems (7) fatigue (8) physical complaints (9) daily functioning and participation (10) routines, structure and dealing with change and (11) problems in social interaction and communication. Seven out of 11 themes could be measured with generic PROMIS item banks. The four remaining outcomes (sensory stimulation tolerance; irritable behaviour; routines, structure and dealing with change; and sensitivity to sensory stimuli) were found suitable to be inventoried by existing PROMs. Conclusion: The majority of parent-reported problems seemed related to indirect consequences of sensory reactivity, which are suitable to be measured with generic item banks. In sum, we identified a sensory-reactivity PROM (parent-proxy) set consisting of PROMIS® item banks and additional domains that together form a comprehensive and readily available outcome set for sensory reactivity problems in children with ASD. [ABSTRACT FROM AUTHOR]

Background: Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia. Methods: Participants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a "think-aloud" process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds. Results: The participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity. Conclusions: Developed in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments. [ABSTRACT FROM AUTHOR]

Background: Childhood obesity can affect physical as well as psychosocial wellbeing. Therefore, childhood obesity care aims to improve all dimensions of health related quality of life (HRQoL). HRQoL can be measured with the generic questionnaire PedsQL4.0 and the weight-specific IWQOL-Kids. In the Netherlands, HRQoL assessment is conducted by the coordinating professional (CP). The aim of this qualitative study was to examine how and when to implement the measurement and discussion of HRQoL using the PedsQL4.0 and IWQOL-Kids within the integrated care for children with obesity in the Netherlands. Semi-structured interviews were conducted with fourteen CPs, in which the following was discussed: a) familiarity and attributions with regard to the assessment of HRQoL; b) wishes and needs with regard to the usage of the questionnaires; c) its practical incorporation. Results: Interviews revealed that most CPs gained insight into the HRQoL by talking with families. One CP used the PedsQL4.0, the remaining CPs were unfamiliar with the two questionnaires. Even though some barriers, for instance a lack of time, might hinder the implementation of the PedsQL4.0 and IWQOL-Kids, all participants think the usage of either one or both questionnaires would have additional value to the support and care for children with obesity. There was no consensus about the questionnaire of preference. Conclusions: When the right preconditions are met, HRQoL questionnaires have the potential to support CPs in improving the care for children with obesity, tailored to each individual child. [ABSTRACT FROM AUTHOR]

Background: Symptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) tool may be relevant to patients with asthma. The purpose of this study was to evaluate content validity and psychometric performance of the E-RS: COPD in moderate/severe asthma patients. Methods: Content validity of the E-RS: COPD was evaluated in patients with moderate/severe asthma using concept elicitation and cognitive debriefing interviews. Secondary analyses using data from two clinical trials in patients with moderate/severe asthma evaluated the factor structure of the E-RS: COPD plus two supplementary items (wheeze; shortness of breath with strenuous physical activity) and assessed psychometric properties of the tool, which will be referred to as E-RS®: Asthma when used in asthma populations. Results: Qualitative interviews (N = 25) achieved concept saturation for asthma respiratory symptoms. Concepts in the E-RS: COPD were relevant to patients and instructions were understood. Most patients (19/25; 76%) reported experiencing all concepts in the E-RS: COPD; no patients indicated missing symptoms. Secondary analyses of clinical trial data supported the original factor structure (RS-Total and three symptom-specific subscales). The two supplemental items did not fit with this factor structure and were not retained. RS-Total and subscale score reliability was high (internal consistency [α] > 0.70). Validity was demonstrated through significant (P < 0.0001) relationships with the St George's Respiratory Questionnaire (SGRQ) and Asthma Symptom Severity scale. E-RS: Asthma was responsive to change when evaluated using SGRQ, Patient Global Impression of Change and Asthma Quality of Life Questionnaire as anchors (P < 0.0001). Clinically meaningful change thresholds were also identified (RS-Total: − 2.0 units). Conclusions: The E-RS: Asthma is reliable and responsive for evaluating respiratory symptoms in patients with moderate/severe asthma. [ABSTRACT FROM AUTHOR]

Background: Duchenne muscular dystrophy is a rare genetic neuromuscular disorder, which can result in early death due to disease progression. Ataluren is indicated for the treatment of nonsense mutation Duchenne muscular dystrophy, in ambulatory individuals aged two years and older. This study explored the impact of caring for an ambulatory individual with nonsense mutation Duchenne muscular dystrophy, as well as the impact of treatment with ataluren on the caregiver experience, using retrospective recall. Methods: Qualitative interviews were conducted with caregivers in the UK. Interviews were conducted by telephone, were recorded and transcribed. Data were analysed using thematic analysis and saturation was recorded. Results: Ten interviews were conducted with parents of individuals aged 4–19 years. Caregivers reported proximal impacts (physical, emotional, time-related), and distal impacts (work, relationships, social life) of caring for their sons. The relationships between these impacts were illustrated in a conceptual model. Changes to the caregiver experience since initiation with their son's treatment were discussed. Conclusion: Caring for an ambulatory individual with nonsense mutation Duchenne muscular dystrophy has a substantial multifaceted impact on caregivers. Treatments which have the potential to improve symptoms or delay progression, may also have a positive impact on the quality of life of caregivers. [ABSTRACT FROM AUTHOR]

Background: Contrary to common usage in the health sciences, the term "valid" refers not to the properties of a measurement instrument but to the extent to which data-derived inferences are appropriate, meaningful, and useful for intended decision making. The aim of this study was to determine how validity testing theory (the Standards for Educational and Psychological Testing) and methodology (Kane's argument-based approach to validation) from education and psychology can be applied to validation practices for patient-reported outcomes that are measured by instruments that assess theoretical constructs in health. Methods: The Health Literacy Questionnaire (HLQ) was used as an example of a theory-based self-report assessment for the purposes of this study. Kane's five inferences (scoring, generalisation, extrapolation, theory-based interpretation, and implications) for theoretical constructs were applied to the general interpretive argument for the HLQ. Existing validity evidence for the HLQ was identified and collated (as per the Standards recommendation) through a literature review and mapped to the five inferences. Evaluation of the evidence was not within the scope of this study. Results: The general HLQ interpretive argument was built to demonstrate Kane's five inferences (and associated warrants and assumptions) for theoretical constructs, and which connect raw data to the intended interpretation and use of the data. The literature review identified 11 HLQ articles from which 57 sources of validity evidence were extracted and mapped to the general interpretive argument. Conclusions: Kane's five inferences and associated warrants and assumptions were demonstrated in relation to the HLQ. However, the process developed in this study is likely to be suitable for validation planning for other measurement instruments. Systematic and transparent validation planning and the generation (or, as in this study, collation) of relevant validity evidence supports developers and users of PRO instruments to determine the extent to which inferences about data are appropriate, meaningful and useful (i.e., valid) for intended decisions about the health and care of individuals, groups and populations. [ABSTRACT FROM AUTHOR]

Purpose: We evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS. Methods: Cross-sectional, in-person, qualitative interviews were conducted in the United States (Texas, Illinois) and European Union (UK, France) with women aged 40–64 years experiencing moderate to severe VMS (≥35/wk). Main outcomes were impact of VMS on sleep based on concept elicitation and content validity of PROMIS Sleep-Related Impairment and Sleep Disturbance short forms via cognitive debriefing. Results: Thirty-two women (US: n = 16; EU: n = 16) participated. A majority (US: 93.8%; EU: 93.8%) said VMS affected sleep; specifically, they had sleep interrupted by sweating or overheating and had difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US: 75%; EU: 50%). VMS-associated sleep disturbance affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found both PROMIS sleep measures relevant and easy to answer; the Sleep Disturbance measure was considered the most relevant. Participants had no difficulty remembering their experiences over the 7-day recall period and found the response options to be distinct. Conclusion: VMS associated with menopause significantly interferes with sleep and next-day functioning (e.g., work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with moderate to severe VMS found that the PROMIS Sleep-Related Impairment and Sleep Disturbance short forms assessed constructs important to understanding sleep in the context of menopause-associated VMS. [ABSTRACT FROM AUTHOR]

Background: Post-stroke fatigue (PSF) is commonly reported and described as disabling by patients recovering from stroke. However, a major challenge is how to accurately diagnose and assess PSF. Therefore, the aim of this study was to explore PSF as it is experienced by stroke survivors and described by health professionals to guide future development of a PSF-specific PROM. Methods: Individual semi-structured interviews were conducted with stroke survivors experiencing PSF (n = 9) and three focus groups were conducted with health professionals (n = 16). Data were analyzed through inductive content analysis. Results: The analysis revealed four themes illustrating the experience and descriptions of PSF: 1) PSF characteristics, 2) interfering and aggravating factors, 3) management, and 4) PSF awareness, which refers to stroke survivors first becoming aware of PSF after their initial hospital admission. Conclusion: This study highlights the complexity and multidimensionality of PSF. The results from this study will guide future development of a PSF-PROM and support its content validity. [ABSTRACT FROM AUTHOR]

Background: Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) is a child-centred caries-specific quality of life measure. This study aimed to select, and validate with children, a classification system for a paediatric condition-specific preference-based measure, based on CARIES-QC. Methods: First, a provisional classification system for a preference-based measure based on CARIES-QC was identified using Rasch analysis, psychometric testing, involvement of children and parents, and the developer of CARIES-QC. Second, qualitative, semi-structured 'think aloud' validation interviews were undertaken with a purposive sample of children with dental caries. The interviewer aimed to identify whether items were considered important and easily understood, whether any were overlapping and if any excluded items should be reintroduced. Interview recordings were transcribed verbatim and thematic analysis conducted. Results: Rasch analysis identified poor item spread for the items 'cross' and 'school'. Items relating to eating were correlated and the better performing items were considered for selection. Children expressed some confusion regarding the items 'school' and 'food stuck'. Parent representatives thought that impacts surrounding toothbrushing ('brushing') were encompassed by the item 'hurt'. Five items were selected from CARIES-QC for inclusion in the provisional classification system; 'hurt', 'annoy', 'carefully', 'kept awake' and 'cried'. Validation interviews were conducted with 20 children aged 5–16 years old. Participants thought the questionnaire was straightforward and covered a range of impacts. Children thought an item about certain foods being 'hard to eat' was more relevant than one about having to eat more carefully because of their teeth and so the 'carefully' item was replaced with 'hard to eat'. Conclusion: Following child-centred modification, the preliminary five-item classification system is considered valid and suitable for use in a valuation survey. The innovative child-centred methods used to both identify and validate the classification system can be applied in the development of other preference-based measures. [ABSTRACT FROM AUTHOR]

Background: Hip and knee replacement are effective procedures for end-stage arthritis that has not responded to medical management. However, until now, there have been no validated, patient-reported tools to measure early recovery in this growing patient population. The process of development and psychometric evaluation of the Oxford Arthroplasty Early Recovery Score (OARS), a 14-item patient-reported outcome measure (PROM) measuring health status, and the Oxford Arthroplasty Early Change Score (OACS) a 14-item measure to assess change during the first 6 weeks following surgery is reported. Patients and methods: A five-phased, best practice, iterative approach was used. From a literature based starting point, qualitative interviews with orthopaedic healthcare professionals, were then performed ascertaining if and how clinicians would use such a PROM and change measure. Analysis of in-depth patient-interviews in phase one identified important patient-reported factors in early recovery which were used to provide questionnaire themes. In Phase two, candidate items from Phase One interviews were generated and pilot questionnaires developed and tested. Exploratory factor analysis with item reduction and final testing of the questionnaires was performed in phase three. Phase Four involved validation testing. Results: Qualitative interviews (n = 22) with orthopaedic healthcare professionals, helped determine views of potential users, and guide structure. In Phase One, factors from patient interviews (n = 30) were used to find questionnaire themes and generate items. Pilot questionnaires were developed and tested in Phase Two. Items were refined in the context of cognitive debrief interviews (n = 34) for potential inclusion in the final tools. Final testing of questionnaire properties with item reduction (n = 168) was carried out in phase three. Validation of the OARS and OACS was performed in phase four. Both measures were administered to consecutive patients (n = 155) in an independent cohort. Validity and reliability were assessed. Psychometric testing showed positive results, in terms of internal consistency and sensitivity to change, content validity and relevance to patients and clinicians. In addition, these measures have been found to be acceptable to patients throughout early recovery with validation across the 6 week period. Conclusions: These brief, easy-to-use tools could be of great use in assessing recovery pathways and interventions in arthroplasty surgery. [ABSTRACT FROM AUTHOR]

Background: Anemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients' health-related quality of life. Methods: We conducted qualitative concept elicitation (CE) and cognitive debriefing (CD) interviews to assess the frequency, duration, and severity of symptoms and impacts associated with anemia of CKD and to facilitate the development of a new patient-reported outcome (PRO) measure. We interviewed 36 patients with CKD and hemoglobin levels ≥8.0 to <12.0 g/dL using a semi-structured interview guide developed specifically for this study until saturation was reached. We used MAXQDA to perform qualitative analysis of interview transcripts to determine the most relevant symptoms and impacts (based on the frequency of concept mentions) experienced by participants. Results: Most participants had stage 4/5 CKD (81%) and were being treated with an erythropoietin stimulating agent (69%). Spontaneously reported symptoms included feeling tired (79%), shortness of breath (39%), and weak/lacking strength (36%). We developed the Chronic Kidney Disease and Anemia Questionnaire (CKD-AQ), which includes 23 items assessing frequency and severity of the most relevant symptoms and impacts identified by patients with anemia of CKD. The CD interviews confirmed the clarity and relevance of the concepts identified in the CE phase. Conclusion: The CKD-AQ is a novel PRO measure that captures the frequency and severity of the most relevant symptoms and impacts associated with anemia of CKD. Future studies will evaluate its psychometric properties and its potential utility in anemia management. [ABSTRACT FROM AUTHOR]

Issues of feasibility, acceptability, satisfaction, safety, and fidelity were examined in a single case program review as an initial step to assessment of the clinical utility of the SAFE PLACE program, a unique multi-disciplinary intervention program for children with complex trauma and sensory processing disorder. The feasibility of conducting a pilot intervention study was also examined. A mixed methods, single-case, program review was conducted. The intervention was the 12-week SAFE PLACE program with pre and post-intervention baseline periods. Random intervention sessions were assessed for fidelity. Post-program interviews and questionnaires were utilized to obtain qualitative and quantitative information on feasibility, acceptability, satisfaction, and safety. The SAFE PLACE fidelity measure demonstrated the intervention was safe and implemented with fidelity to the intervention model. The intervention was acceptable to the family with an average rating of 4.3 (between acceptable and perfectly acceptable) on a five-point scale. The family was very satisfied with the intervention and its outcomes with a rating of 4.75 (between satisfied and very satisfied). Numerous positive qualitative comments about participation in the program and outcomes of the intervention were spontaneously provided by the family. Staff satisfaction rating was 4.3. Scheduling, staffing and financial reimbursement feasibility challenges were identified. Preliminary outcomes of the intervention suggested positive results and provided guidance for selection of future clinical and research outcome measures. The SAFE PLACE intervention was found to be a safe, acceptable intervention with high caregiver satisfaction that could be delivered with fidelity. The program was deemed feasible for future research studies but scheduling, staffing and financial reimbursement challenges may inhibit implementation in routine clinical practice. [ABSTRACT FROM AUTHOR]

Background: Neurotrophic keratopathy/keratitis (NK) is a rare disease of the cornea that can lead to anatomical loss of the eye. Little is known about the NK experience from the patients' perspective. The objectives of this study were to examine the symptomatic experience and impacts of NK on patients and assess the overall comprehension, relevance, and content validity of a new questionnaire. Methods: This was a cross-sectional, qualitative study conducted with NK patients with varying levels of disease severity, recruited from one clinical site. One-on-one interviews using concept elicitation and cognitive interviewing techniques were conducted. Results: Fourteen NK patients participated; 64.3% were female (n = 9), mean age was 65.7 ± 13.3, and 14.3% (n = 2), 21.4% (n = 3), and 64.3% (n = 9) were classified as Mackie stage I, stage II, or stage III, respectively. Participants reported 24 concepts, including: redness (n = 12, 86%), sensitivity to light (n = 11, 79%), general discomfort (n = 9, 64%), dry eye (n = 9, 64%), reduced visual acuity (n = 9, 64%), blurred vision (n = 8, 57%), and eye fatigue (n = 8, 57%). No new concepts were reported after the 13th interview. The most frequently reported impacts included frustration (n = 10, 71%), driving impairment (n = 8, 57%), reading impairment (n = 7, 50%), difficulty watching television (n = 7, 50%), and concern with potentially losing their eyesight due to NK (n = 6, 43%). Participants provided positive feedback on the draft NK Questionnaire (NKQ) and felt that it was comprehensive and relevant to their experience with NK. Additionally, the recall period, instructions, item concepts, and response options were well-understood by participants. Minor revisions were made to the tool for consistency (i.e., the timeframe "in the past 7 days" was added to items 12–14); item 14 was modified to include "how often"; examples were added to item 9. Conclusions: The results of the concept elicitation portion of the qualitative study support the content validity of the draft NKQ. The clinically significant concepts identified in the literature and raised during concept elicitation are included as items in the questionnaire. Further assessment of the psychometric properties should be conducted in support of this new tool to measure the effect of new treatments on symptoms and impacts associated with NK. [ABSTRACT FROM AUTHOR]

Background: Endometriosis is a common, chronic, impactful condition in women of reproductive age. In the absence of established sensitive and specific biomarkers, disease severity is determined by patient-reported symptoms and impacts. This article details the development of two new patient-reported outcome (PRO) measures designed to assess efficacy endpoints in clinical studies: The Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS). Methods: The ESD and EIS were developed according to best practice and scientific standards (including the Food and Drug Administration (FDA) PRO Guidance) and with extensive input from women with surgically-confirmed endometriosis. Research included: a review of published qualitative literature; concept elicitation interviews in the US, Germany and France (n = 45) to explore the experiences of women with endometriosis and to inform ESD and EIS development; and cognitive interviews in the US and Germany (n = 31) to assess relevance and understanding of the ESD and EIS and usability of administration using an electronic handheld device. The FDA and the European Medicines Agency (EMA) as well as PRO and clinical experts were consulted throughout the process. Results: Pelvic pain was identified as the most frequent, severe and bothersome symptom for women with endometriosis. Pain was reported to be greatest during menstruation (dysmenorrhea) and during or after sexual intercourse (dyspareunia). Pain resulted in significant impairments in physical activities, work/study, social/leisure activities, household activities and sexual functioning. All women highlighted the emotional impact of endometriosis. Descriptions of pain and associated impacts were largely consistent across participants from the US and Europe, with the most notable differences being the words used to describe the location of pain (e.g., 'pelvis' vs. 'abdomen'). Testing during cognitive interviews indicated that the ESD and EIS were well understood and consistently interpreted. Furthermore, all participants found the ePRO devices easy to use and no issues regarding visual presentation, selection of responses or navigation were identified. Conclusions: Evidence from extensive qualitative research supports the content validity of the ESD and EIS as patient-reported measures of the disease-defining symptoms of endometriosis and the associated impact on women's lives. Future research will seek to establish the measurement properties of the measures. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study was to pilot test the English and Urdu version of the Colon Cancer Screening Behaviours Survey among South Asians in Canada. The first objective was to evaluate feasibility of administration, data collection using computer assisted personal interviewing software on a tablet, and response burden. The second objective was to examine the prevalence of colorectal cancer screening among South Asians and evaluate the psychometric properties of sub-scales in the survey. Methods: Purposive, network and snowball sampling were used to recruit participants for this cross-sectional study. Interviewer-led administration of the Colon Cancer Screening Behaviours Survey was conducted across two cities in Ontario, Canada. Qualitative data analysis assessed feasibility; and sub-scales were evaluated through principal component analysis, item-scale correlations, and construct validity using multiple linear and logistic regression. Results: A total of 328 South Asians participated, 47% Urdu speaking, and 53% English speaking. There was a 23% refusal rate to participate. Feasibility identified: (1) successful recruitment despite reasons for refusal; (2) problematic items and response categories; and (3) computer/tablet limitations. Principal component analysis identified 14 components that explained 68.7% of total variance; 34 items were retained after factor analysis. Internal consistency of 4 scales ranged from 0.79–0.91. There were significant differences in perceived barriers scale scores (− 12.21; 95% CI, − 17.13 to - 7.28; p < 0.0001) between those who participated and those who did not participate in screening. No association was found with years of residence and uptake of screening after adjustment (OR 0.91 (0.46–1.79), p = 0.783). Conclusions: Recruitment and data collection methods are feasible among South Asians if functionality of the tablet selected is improved. The Colon Cancer Screening Behaviours Survey was finalized and retained items in sub-scales demonstrated good psychometric properties to assess behaviours for colon cancer screening among South Asians in Canada. The interviewer-led survey may be used by public health, cancer care or other health practitioners to describe or predict colorectal cancer screening behaviours among South Asians in similar settings or adapted and tested in other contexts. [ABSTRACT FROM AUTHOR]

Background: For at least the past two decades, medical educators have worked to improve patient communication and health care delivery to diverse patient populations; despite efforts, patients continue to report prejudice and bias during their clinical encounters. Targeted instruction in implicit bias recognition and management may promote the delivery of equitable care, but students at times resist this instruction. Little guidance exists to overcome this resistance and to engage students in implicit bias instruction; instruction over time could lead to eventual skill development that is necessary to mitigate the influence of implicit bias on clinical practice behaviors.Objective: To explore student perceptions of challenges and opportunities when participating in implicit bias instruction.Approach: We conducted a qualitative study that involved 11 focus groups with medical students across each of the four class years to explore their perceptions of challenges and opportunities related to participating in such instruction. We analyzed transcripts for themes.Key Results: Our analysis suggests a range of attitudes toward implicit bias instruction and identifies contextual factors that may influence these attitudes. The themes were (1) resistance; (2) shame; (3) the negative role of the hidden curriculum; and (4) structural barriers to student engagement. Students expressed resistance to implicit bias instruction; some of these attitudes are fueled from concerns of anticipated shame within the learning environment. Participants also indicated that student engagement in implicit bias instruction was influenced by the hidden curriculum and structural barriers.Conclusions: These insights can inform future curriculum development efforts. Considerations related to instructional design and programmatic decision-making are highlighted. These considerations for implicit bias instruction may provide useful frameworks for educators looking for opportunities to minimize student resistance and maximize engagement in multi-session instruction in implicit bias recognition and management. [ABSTRACT FROM AUTHOR]

Background Joint procurement of medicines is a way to improve access and justice in developing countries. The aimof this study is to determine local indicators for assessing the performance of joint procurement agencies and compare the indicators in those pharmacies which use centralized purchasing before and after this change. Methods This was a mixed method study. In the first qualitative phase, 3 expert panels were held including 20 national experts who were selected through purposeful sampling. Data was analyzed applying a five-stage framework analysis using MAXQDA. In the second quantitative phase, financial, supply and procurement, physical and functional indicators of two hospitals affiliated with joint procurement were assessed and the satisfactions of patients from the pharmacy performance were compared applying a valid questionnaire. Data was analyzed using SPSS through independent test, Paired t-test and ANOVA. Results Results show that after settlement of joint procurement, the cost of transportation has increased by 54%, a part of the cost of overhead has increased by 30%, the cost of manpower has increased by 88.9% and cost of insurance of warehouses has increased by 71.85% in 2016 compared to 2015. In addition, the total costs of holding were 89.8% of selling revenue. In other words, the profit was about 10%of revenue in total. Moreover the average score of pharmacies under the Holding has been higher than similar ones in all aspects of satisfaction from the patients' points of view. Conclusion The one-year experience of deploying centralized purchasing to supply medicine has led to increased income and patient satisfaction. However, increase in staffing costs, longevity, overhead and warehouse costs have been significant that need appropriate monitoring and interventions. [ABSTRACT FROM AUTHOR]

Introduction: Patients and family members can contribute to resident assessment in competency-based medical education. However, few studies have examined the use of patient/family member feedback generated from questionnaire-based assessments. To implement appropriate assessment strategies and optimize feedback use, we need to understand how residents and physician-educators would use feedback from these stakeholders. This study aimed to understand how paediatric residents and physician-educators would use parent feedback generated from questionnaire-based assessments.Methods: This study was conducted at a paediatric academic health science centre. We held dyadic interviews with six residents and six physician-educators. A three-step approach was used to analyze the data: data reduction, data display, and conclusions/verifications. We developed an initial coding scheme, conducted an in-depth review of the data and coded it, finalized our coding scheme, and identified categories.Results: Participants described that they would use parent feedback to: (a) provide additional direct observations of residents’ performances, (b) teach and coach residents, (c) assess residents’ overall performance and progression, and (d) encourage resident self-assessment and behaviour change.Discussion: Parents directly observe residents as they interact with them and their children and, therefore, can provide feedback on residents’ performances. Residency programs should include parent feedback and promote and facilitate its use by residents and physician-educators.Conclusion: This study provides an initial understanding of how paediatric residents and physician-educators would use parent feedback if they were to receive it. This information, combined with future research, can inform the development and implementation of parent feedback strategies in competency-based medical education. [ABSTRACT FROM AUTHOR]

Objectives: Undernutrition is a major health concern particularly in vulnerable older adults. The present study aimed to reveal the causes of undernutrition as reported by community-dwelling older adults. Design: Twenty-five semi-structured interviews and two focus group discussions were performed and analyzed. Setting: Community-dwelling. Participants: Older adults. Measurements: A questionnaire on demographics, Short Nutritional Assessment Questionnaire 65+ and interviews on the potential causes of undernutrition. Results: 33 older adults agreed to participate in the interviews and focus groups. Our findings indicate that a wide variety of causes of undernutrition, both modifiable and non-modifiable, were mentioned by the older adults. Many modifiable causes of undernutrition were reported in the mental, social or food & appetite theme, such as poor food quality provided by meal services, the inability to do groceries, loneliness and mourning. Non-modifiable causes included, forgetfulness, aging, surgery and hospitalization. Conclusions: This study provides guidance to better understand the underlying causes of undernutrition from an older adult's perspective. The modifiable causes provide specific direction towards practical implications that might decrease or prevent undernutrition. Non-modifiable causes should raise awareness of an increased risk of undernutrition by health professionals in primary and secondary care, caregivers and family members. [ABSTRACT FROM AUTHOR]

Objectives: To describe the process and feasibility of our randomised, controlled intervention study (NuAD trial) that positively affected the nutrition and quality of life, and prevented falls of home-dwelling persons with Alzheimer disease (AD). Design, setting, participants: This qualitative study comprised 40 persons with AD and spousal caregivers of our trial. Our intervention during one year involved tailored nutritional guidance for these couples. The nutritionist's field notes (about 100 pages) and the participant feedback questionnaires (N = 28) served to analyse the feasibility of intervention, factors promoting the application of intervention and challenges hindering it. Thematic content analysis served to analyse our data with the grounded theory approach. Results: We identified several positive elements promoting better nutrition: positive attitudes on nutrition to participants including a participant-centred approach, positive feedback, findings of food diaries and practical suggestions. Home visits by the nutritionist were convenient and participants felt that someone cares. Group meetings which included protein-rich snacks strengthened the nutritional message by enabling discussions and socialising. The oral nutritional supplements (ONS) helped participants to regain their energy and to motivate them to exercise and make changes in their diets. Obstacles to making changes in diets included participants' false ideas about nutrition, especially with regard to weight gain. Health problems and functional limitations hampered food management, and some families had inveterate eating habits. The positive feedback from participants indicated the feasibility of our tailored nutritional guidance. Conclusions: Assessment-based, tailored nutritional guidance implemented with a personal and positive approach may inspire and empower AD families to make positive changes in their diets, leading them to improved nutrition and quality of life. [ABSTRACT FROM AUTHOR]